Ricoeur 's phenomenological hermeneutical philosophy inspired the analysis .


Patients initiated exercising median 15 days postoperative .


Eight patients included in the interview study dropped out of the intervention due to side effects of chemotherapy ( n = 3 ) and external circumstances ( n = 5 ) .


The mean attendance rate for the eleven participants who completed the intervention was 82 % .


No patients experienced severe adverse events .


Motivation for participation included patients ' expectations of physical benefits and the security of having professionals present .


Patients experienced physical and emotional benefits and affirmed their social identity .


Barriers were primarily related to side effects of chemotherapy .


The exercise intervention was undertaken safely by operable lung cancer patients initiated 2 weeks after surgery .


The intervention put the patients on track to a healthier lifestyle regarding physical activity and smoking .


The study indicates that exercise initiated early in the treatment trajectory is beneficial for operable lung cancer patients and especially for those who were physically active and motivated pre-illness and who did not experience side effect of treatment .


We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers , linked to evidence-based treatment algorithms and reference guides ( the longer-term stroke care system of care ) to address the poor longer-term recovery experienced by many patients with stroke .


A pragmatic , multicentre , cluster randomized controlled trial of this system of care .


Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice .


The primary outcome was improved patient psychological well-being ( General Health Questionnaire-12 ) at 6 months ; secondary outcomes included functional outcomes for patients , carer outcomes , and cost-effectiveness .


Follow-up was through self-completed postal questionnaires at 6 and 12 months .


Thirty-two stroke services were randomized ( 29 participated ) ; 800 patients ( 399 control ; 401 intervention ) and 208 carers ( 100 control ; 108 intervention ) were recruited .


In intention to treat analysis , the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was -0.6 points ( 95 % confidence interval , -1.8 to 0.7 ; P = 0.394 ) indicating no evidence of statistically significant difference between the groups .


Costs of Stroke Care Coordinator inputs , total health and social care costs , and quality-adjusted life year gains at 6 months , 12 months , and over the year were similar between the groups .


This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice .


URL : http://www.controlled-trials.com .


Unique identifier : ISRCTN 67932305 .


To investigate the comparative efficacy of cognitive behavioral therapy ( CBT ) , Tai Chi Chih ( TCC ) , and sleep seminar education control ( SS ) on the primary outcome of insomnia diagnosis , and secondary outcomes of sleep quality , fatigue , depressive symptoms , and inflammation in older adults with insomnia .


Randomized controlled , comparative efficacy trial .


Los Angeles community .


123 older adults with chronic and primary insomnia .


Random assignment to CBT , TCC , or SS for 2-hour group sessions weekly over 4 months with follow-up at 7 and 16 months .


Insomnia diagnosis , patient-reported outcomes , polysomnography ( PSG ) , and high-sensitivity C-reactive protein ( CRP ) levels .


CBT performed better than TCC and SS in remission of clinical insomnia as ascertained by a clinician ( P < 0.01 ) , and also showed greater and more sustained improvement in sleep quality , sleep parameters , fatigue , and depressive symptoms than TCC and SS ( all P values < 0.01 ) .


As compared to SS , CBT was associated with a reduced risk of high CRP levels ( > 3.0 mg/L ) at 16 months ( odds ratio [ OR ] , 0.26 [ 95 % CI , 0.07-0 .97 ] P < 0.05 ) .


Remission of insomnia was associated with lower levels of CRP ( P < 0.05 ) at 16 months .


TCC was associated with improvements in sleep quality , fatigue , and depressive symptoms as compared to SS ( all P 's < 0.05 ) , but not insomnia remission .


PSG measures did not change .


Treatment of late-life insomnia is better achieved and sustained by cognitive behavioral therapies .


Insomnia treatment and remission reduces a marker of inflammatory risk , which has implications for cardiovascular morbidity and diabetes observed with sleep disturbance in epidemiologic surveys .


The use of bone marrow mononuclear cells ( BM-MNCs ) has achieved great outcomes in clinical practice .


We aim to evaluate the efficacy and safety of autologous BM-MNC infusion and hyperbaric oxygen therapy ( HOT ) in type 2diabetes mellitus .


This single-center , randomized , open-label , controlled clinical trial with a factorial design included two phases .


The patients received standard medical therapy in the run-in phase ; in the treatment phase , patients with glycated hemoglobin of 7.5-9 .5 % were randomly assigned into four groups and underwent BM-MNC infusion along with HOT ( BM-MNC + HOT group ) , BM-MNC infusion ( BM-MNC group ) , HOT ( HOT group ) and standard medical therapy ( control group ) , respectively .


The area under the curve of C-peptide was recorded as a primary end point .


Our research is registered at ClinicalTrials.gov ( NCT00767260 ) .


A total of 80 patients completed the follow-up .


At 12months after treatment , the area under the curve of C-peptide ( ng/mL per 180 min ) of the BM-MNC + HOT group and the BM-MNC group were significantly improved ( 34.0 % and 43.8 % from the baseline , respectively ) .


The changes were both significant compared with that in the control group , but no remarkable change was observed in the HOT group .


Treatment-related adverse events were mild , including transient abdominal pain ( n = 5 ) and punctual hemorrhage ( n = 3 ) .


BM-MNC infusion for type 2 diabetes mellitus improves islet function and metabolic control , with mild adverse effects .


HOT does not synergize with BM-MNC infusion .


Alcohol consumption in adolescence is associated with problem drinking in later life , and there is a need to develop evidence-based interventions to reduce adolescent alcohol consumption .


The aims of the present study were to test the ability of a very brief intervention based on self-affirmation theory to reduce alcohol consumption in a sample of adolescents and to examine potential mediators of the effects .


67 adolescents were randomly allocated either to form a self-affirming implementation intention or to complete a distractor task .


All participants were exposed to a threatening message concerning the health risks of alcohol consumption .


The main outcome measure was subsequent alcohol intake , but message processing ( operationalized as perceived threat and message derogation ) , behavioral intention , and self-efficacy were also measured as potential mediators .


The intervention produced a significant decrease in alcohol consumption : Participants in the self-affirming implementation intention condition consumed 2.48 fewer grams of pure alcohol per day at the end of the study than adolescents who completed the distractor task .


The effect was not mediated by perceived threat , message derogation , behavioral intention , or self-efficacy .


The findings provide support for the efficacy of the self-affirming implementation intention for promoting health behavior change and extend previous research by testing an adolescent sample and observing longer term effects .


Further research is needed to find out what mediates the effects of self-affirming implementation intentions on health behavior change .


Impaired sexual function is increasingly recognized as a side effect of psychopharmacological treatment .


However , underlying mechanisms of action of the different drugs on sexual processing are still to be explored .


Using functional magnetic resonance imaging , we previously investigated effects of serotonergic ( paroxetine ) and dopaminergic ( bupropion ) antidepressants on sexual functioning ( Abler et al. , 2011 ) .


Here , we studied the impact of noradrenergic and antidopaminergic medication on neural correlates of visual sexual stimulation in a new sample of subjects .


Nineteen healthy heterosexual males ( mean age 24 years , SD 3.1 ) under subchronic intake ( 7 days ) of the noradrenergic agent reboxetine ( 4 mg/d ) , the antidopaminergic agent amisulpride ( 200mg/d ) , and placebo were included and studied with functional magnetic resonance imaging within a randomized , double-blind , placebo-controlled , within-subjects design during an established erotic video-clip task .


Subjective sexual functioning was assessed using the Massachusetts General Hospital-Sexual Functioning Questionnaire .


Relative to placebo , subjective sexual functioning was attenuated under reboxetine along with diminished neural activations within the caudate nucleus .


Altered neural activations correlated with decreased sexual interest .


Under amisulpride , neural activations and subjective sexual functioning remained unchanged .


In line with previous interpretations of the role of the caudate nucleus in the context of primary reward processing , attenuated caudate activation may reflect detrimental effects on motivational aspects of erotic stimulus processing under noradrenergic agents .


Several studies on lactobacilli have demonstrated they are effective against atopic dermatitis ( AD ) in children , but there are very few reports of their effects in adults .


We investigated the changes in AD symptoms in adults after the ingestion of the Lactobacillus acidophilus strain L-92 ( L-92 ) , which has been shown to have a curative effect on AD in children .


A double-blind , parallel-group , placebo-controlled comparison was performed on 49 AD patients aged 16 years using heat-killed L-92 .


Skin lesions were assessed using the SCORing AD ( SCORAD ) index before the start of L-92 ingestion and 4 and 8 weeks after ingestion .


Serum cytokine and blood marker levels were measured 8 weeks after the start of L-92 ingestion .


The group that ingested L-92 had lower SCORAD scores than the controls ( p = 0.002 ) .


The L-92 group also had decreased ratios of change for eosinophil count ( p = 0.03 ) and increased ratios of change for serum TGF - ( p = 0.03 ) .


Ratios of change for serum TGF - rose significantly ( p = 0.04 ) in patients showing mitigated symptoms with L-92 administration .


Administration of heat-killed L-92 was effective for AD symptoms in adults .


L-92 may contribute to the suppression of Th2-dominant inflammation .


Our preliminary trial is the first to report the effects of L-92 on adult AD .


The incidence and severity of gastroesophageal reflux disease ( GERD ) in Japan tends to increase in elderly women .


Rikkunshito ( RKT ) , a traditional Japanese medicine , acts as a prokinetic agent and improves gastric emptying and gastric accommodation .


Our previous prospective randomized placebo-controlled study showed that RKT combined with a standard-dose of rabeprazole ( RPZ ) significantly improved the acid-related dysmotility symptoms ( ARD ) in elderly patients with proton pump inhibitor ( PPI ) - refractory non-erosive reflux disease ( NERD ) .


This study aimed to evaluate clinical characteristics of elderly PPI-refractory NERD patients with ARD symptoms who responded to RKT .


Two hundred forty-two patients with PPI-refractory NERD were randomly assigned to 8 weeks of either RPZ ( 10 mg/q .


d. ) + RKT ( 7.5 g/t .


i.d. ) ( RKT group ) or RPZ + placebo ( PL group ) .


Among them , 95 were elderly ( 65 years ) with ARD ( RKT group : n = 52 ; PL group : n = 43 ) .


We analyzed the changes using the 12 subscale score of frequency scale for the symptoms of GERD ( FSSG ) and 15 items of the Gastrointestinal Symptom Rating Scale at 4 and 8 weeks and compared the therapeutic efficacy between the 2 groups .


There were no marked differences in baseline demographic or clinical characteristics in the 2 groups except for rate of current smoking .


The FSSG score ( mean SD at 0 , 4 , and 8 weeks ) in both the RKT ( 16.0 7.0 ; 9.9 8.4 ; 7.0 6.4 ) and PL ( 15.1 6.4 ; 10.9 6.7 , 11.1 8.5 ) groups significantly decreased after treatment .


However , the degree of improvement of total and ARD scores of FSSG after the 8-week treatment was significantly greater in the RKT group than in the PL group .


Combination therapy with RKT for 8 weeks showed significant improvement in 3 subscale scores ( abdominal bloating , heavy feeling in stomach and sick feeling after meals ) of the ARD domain and 1 subscale score ( heartburn after meals ) of the reflux symptom domain .


RKT may be useful for improving GERD symptoms in elderly PPI-refractory NERD patients with ARD .


Thus , RKT was particularly effective for resolving postprandial GERD symptoms ( heavy feeling in stomach , sick feeling , and heartburn after meals ) .


( UMIN000005880 ) .


Acute exacerbation of chronic obstructive pulmonary disease ( AECOPD ) is a common cause of morbidity and mortality .


Traditional Chinese medicine ( TCM ) is used to treat AECOPD as adjunctive therapy .


This study aimed to evaluate the efficacy and safety of the TCM formula Xuan Bai Cheng Qi as an adjuvant therapy for AECOPD patients with the syndrome type of phlegm-heat obstructing the lungs .


A multicenter , randomized , double-blind , placebo-controlled clinical trial was conducted .


A total of 244 patients were divided into the intervention group ( n = 122 , treated with conventional medicine and Xuan Bai Cheng Qi ) and the control group ( n = 122 , treated with conventional medicine and placebo ) .


Total symptom scores ( cough , phlegm , wheezing , chest congestion ) before treatment and at 3 , 5 , 7 , 10 days post-treatment were recorded .


Lung function , arterial blood gas , serum inflammatory cytokines , oxidation/anti-oxidation index were observed before treatment and at the end of the 10-day treatment .


A total of 242 patients completed the study .


The full analysis set ( FAS ) population was 244 and the per-protocol analysis set ( PPS ) population was 229 .


After the 10-day treatment , symptom scores of the Xuan Bai Cheng Qi group were significantly lower over time compared with the control group ( FAS : mean difference -1.84 , 95 % CI -2.66 to -1.03 , P < .001 ; PPS : mean difference -1.87 , 95 % CI -2.71 to -1.03 , P < .001 ) .


FEV1 , FVC , and FEV1 % pred were significantly higher over time in the Xuan Bai Cheng Qi group compared with those in the control group ( day 10 , FAS and PPS : P < .05 ) .


PaO2 and PaCO2 were significantly improved in the Xuan Bai Cheng Qi group ( day 10 , FAS and PPS : P < .05 ) .


Xuan Bai Cheng Qi was also found to ameliorate cytokine levels and oxidation/antioxidant index compared with placebo .


There were no differences in safety variables and adverse events between the two groups .


Xuan Bai Cheng Qi formula appears to be a safe and beneficial treatment for AECOPD of phlegm-heat obstructing the lungs syndrome type .


Both contingency management ( CM ) and exercise have shown promise as smoking cessation treatments , but their combined effects have not been evaluated .


The present study evaluated whether CM ( in which motivational incentives are provided for abstinence ) plus exercise reduced smoking more than either component alone .


In a within-subjects design , 20 smokers were exposed to exercise plus CM , exercise plus CM-control ( non-contingent incentives ) , inactivity plus CM , and inactivity plus CM-control .


CM increased latencies to smoke and decreased total puffs ( Mdns = 39.6 min and .8 puffs , respectively ) relative to CM-control ( Mdns = 2.5 min and 12.8 puffs ) .


Exercise decreased craving relative to baseline for craving based on both the pleasurable consequences of smoking ( D = -10.7 on a 100-point visual analog scale ) and anticipated relief from withdrawal ( D = -5.9 ) , whereas inactivity increased both components of craving ( Ds = 7.6 and 3.5 ) .


Exercise had no effect on smoking or a measure of temporal discounting .


Although exercise decreased craving , it did not affect smoking behavior .


Exercise plus CM was not more effective than CM alone .


The diagnosis of varicocle is clinical .


In order to improve diagnosis of varicocele , we compared the clinical with the ultrasound findings in schoolboys with the condition .


This is because the conditions can affect testicular growth .


It was a cross-sectional , descriptive study of schoolboys aged from 10 to 19 years who had varicocele .


Among 2724 boys examined , 149 had varicocele and only 81 had scrotal ( 18 with Doppler ) and renal ultrasound examination .


Among the 81 adolescents who were clinically diagnosed with varicocele and also with the aid of ultrasound scan , 25 , 36 and 20 had grade 1 , 2 and 3 , respectively .


Testicular hypotrophy ( TH ) was clinically noticed in 17 cases .


At ultrasonography , varicocele was bilateral in 87.66 % and unilateral in 12.34 % ( P = 0.01 ) with 32 adolescents ( 39.51 % ) showing TH compared with 20.99 % being diagnosed with TH using clinical examination alone ( P = 0.01 ) .


In 50 schoolboys ( 61.73 % ) with unilateral varicocele , a subclinical type was discovered at other side .


Renal ultrasound revealed abnormalities in 4.93 % of cases .


Doppler ultrasound helped in finding varicoceles along the top edge of the testis ( n = 15 ) and under tunica albuginea ( n = 3 ) .


TH due to varicocele is better studied by ultrasound .


To evaluate the psychological consequences among family members given the option to be present during the CPR of a relative , compared with those not routinely offered the option .


Prospective , cluster-randomized , controlled trial involving 15 prehospital emergency medical services units in France , comparing systematic offer for a relative to witness CPR with the traditional practice among 570 family members .


Main outcome measure was 1-year assessment included proportion suffering post-traumatic stress disorder ( PTSD ) , anxiety and depression symptoms , and/or complicated grief .


Among the 570 family members [ intention to treat ( ITT ) population ] , 408 ( 72 % ) were evaluated at 1 year .


In the ITT population ( N = 570 ) , family members had PTSD-related symptoms significantly more frequently in the control group than in the intervention group [ adjusted odds ratio , 1.8 ; 95 % confidence interval ( CI ) 1.1-3 .0 ; P = 0.02 ] as did family members to whom physicians did not propose witnessing CPR [ adjusted odds ratio , 1.7 ; 95 % CI 1.1-2 .6 ; P = 0.02 ] .


In the observed cases population ( N = 408 ) , the proportion of family members experiencing a major depressive episode was significantly higher in the control group ( 31 vs. 23 % ; P = 0.02 ) and among family members to whom physicians did not propose the opportunity to witness CPR ( 31 vs. 24 % ; P = 0.03 ) .


The presence of complicated grief was significantly greater in the control group ( 36 vs. 21 % ; P = 0.005 ) and among family members to whom physicians did not propose the opportunity to witness resuscitation ( 37 vs. 23 % ; P = 0.003 ) .


At 1 year after the event , psychological benefits persist for those family members offered the possibility to witness the CPR of a relative in cardiac arrest .


During leisure activities young people are often exposed to excessive noise levels resulting in an increase of noise-induced symptoms such as hearing loss , tinnitus and hyperacusis .


Noise-induced tinnitus is often perceived after loud music exposure and provides an important marker for overexposure as a temporary threshold shift that is often not experienced by the individual itself .


As oxidative stress plays an important role in the pathogenesis of noise-induced hearing loss , the use of antioxidants to prevent hearing damage has recently become the subject of research .


This study proposes a randomized , double-blind , placebo-controlled crossover trial to assess the effects of a prophylactic combination of N-acetylcysteine ( 600 mg ) and magnesium ( 200 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 16 kHz , distortion product otoacoustic emissions , transient-evoked otoacoustic emissions and speech-in-noise testing will be performed prior to and within 7 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 present protocol is registered at ClinicalTrials.gov : NCT01727492 .


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 5 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 ( 17 randomized to CMHAB ; 13 randomized to NAB ) with mean age of 40.3 , Injury Severity Score of 30 , Abbreviated Injury Score ( AIS ) - abdomen of 3.68 , APACHE II score of 14.4 , and 67 % 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 ( 15 vs 22 days ; P < .05 ) .


Intraoperative adhesion scores were not different during the first four operations but diverged significantly at the 5th operative intervention or after about 1 week of OA therapy .


After the 5th operation , adhesion scores in the NAB group were 67 % greater ( approximately 1 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 > 9 days or requiring 5 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 = 151 dyads ) was used to determine if the effect of TDP on driver performance operated through five hypothesized mediators : ( 1 ) parent-perceived social support ; ( 2 ) teen-perceived social support ; ( 3 ) parent engagement ; ( 4 ) practice quantity ; and ( 5 ) practice diversity .


Certified driving evaluators , blinded to teens ' treatment allocation , assessed teens ' driving performance 24weeks 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 .


161 ADHF patients ( 78 years ; 46 % female ; ejection fraction 31 % ) were randomized to 8-hour continuous infusions of : a ) high-dose furosemide ( HDF , n = 50 , 20mg/h ) , b ) low-dose furosemide and low-dose dopamine ( LDFD , n = 56 , 5mg/h and 5 g kg ( -1 ) min ( -1 ) respectively ) , or c ) low-dose furosemide ( LDF , n = 55 , furosemide 5mg/h ) .


The main outcomes were 60-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 ) 0.3 mg/dL ) , and length of stay ( LOS ) were also assessed .


The urinary output at 2 , 4 , 6 , 8 , and 24h was not significantly different in the three groups .


Neither the ACM at day 60 ( 4.0 % , 7.1 % , and 7.2 % ; P = 0.74 ) or at one year ( 38.1 % , 33.9 % and 32.7 % , P = 0.84 ) nor the HHF at day 60 ( 22.0 % , 21.4 % , and 14.5 % , P = 0.55 ) or one year ( 60.0 % , 50.0 % , and 47 % , P = 0.40 ) 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 1 ( 24 % vs. 11 % vs. 7 % , P < 0.0001 ) but not at sCr peak ( 44 % vs. 38 % vs. 29 % , P = 0.27 ) .


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 37 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 15-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 CO2 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 ( 2.04 0.75 vs 2.17 0.7 , p = 0.24 ) , nor the total blood loss ( p = 0.43 ) .


On the cocaine side , there was a correlation between surgical field grade and duration of surgery ( p < 0.05 ) as well as blood loss ( p < 0.05 ) and MAP ( p < 0.05 ) .


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 < 40 % , optimized medical therapy , and ineligible for cardiac resynchronization received BAT for 6 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 6 months from 45.1 7.7 to 31.3 8.3 bursts/min and from 67.6 12.7 to 45.1 11.6 bursts/100 heartbeats , decreases of 31 % and 33 % , respectively ( P < 0.01 ) .


Concomitant improvements occurred in baroreflex sensitivity , EF , NYHA class , quality of life and 6 min hall walk ( 6 MHW ) distance ( P 0.05 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 365 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 95 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 1.99 , 95 percent CI 1.07-3 .72 ) after controlling for age , level of education , and difficulty paying a $ 100 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 = 0.04 , bias-corrected 95 percent CI 0.004-0 .105 , 21.2 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 .


80 ASA physical status 1 and 2 women scheduled for elective breast cancer surgery .


Patients were randomly allocated to two groups in double-blinded fashion : Group B ( betamethasone ; 37 pts ) and Group C ( control ; 38 pts ) .


Group B received 8 mg of betamethasone intravenously before the start of surgery .


The rate of PONV and pain were recorded using a numeric rating scale ( NRS ; 0-10 ) , as well as rescue doses of antiemetics ( ondansetron ) and analgesics ( ketobemidone ) .


There was a significant lower incidence of postoperative nausea ( PON ) scoring NRS 1 in Group B in the 4 to 12-hour period compared with Group C ( P = 0.02 ) .


The cumulative incidence of PON was 57 % in Group B versus 68 % in Group C ( P = 0.27 ) .


The overall incidence of postoperative vomiting ( POV ) was 18 % and 20 % in Groups B and C , respectively .


Postoperative pain was reduced by 40 % in Group B in the 4 to 12-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 2 inhibitor , inhibits reabsorption of glucose in the proximal renal tubule .


It was developed for the treatment of type 2 diabetes mellitus .


For this first human study of luseogliflozin , randomized , single-blind , placebo-controlled , single ascending dose ( 1-25mg ) and multiple ascending dose ( 5 or 10mg/day , 7days ) 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 0.667 to 2.25 h.


The mean plasma half-life of luseogliflozin ( T 1/2 ) after multiple dosing for 7days ranged from 9.14 to 10.7 h , and no detectable accumulation of luseogliflozin was observed .


Urinary glucose excretion increased in a dose-dependent manner , ranging from 18.9 to 70.9 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 619 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 10 % .


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 45.2 % ; with DHAP the response rate was 44.0 % ( 95 % CI for difference , -9.0 % to 6.7 % ) , meeting protocol-defined criteria for noninferiority of GDP ( P = .005 ) .


Similar results were obtained in a per-protocol analysis .


The transplantation rates were 52.1 % with GDP and 49.3 % with DHAP ( P = .44 ) .


At a median follow-up of 53 months , no differences were detected in event-free survival ( HR , 0.99 ; stratified log-rank P = .95 ) or overall survival ( HR , 1.03 ; P = .78 ) between GDP and DHAP .


Treatment with GDP was associated with less toxicity ( P < .001 ) and need for hospitalization ( P < .001 ) , and preserved quality of life ( P = .04 ) .


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 200 consecutive CRRC patients that met clinic discharge criteria ( HbA1c 7 % ( 53 mmol/mol ) ; blood pressure 140/80 mmHg for those with diabetes and 140/90 mmHg for those without diabetes ; and an LDL-cholesterol 2.59 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 1:1:1 ratio , followed by a 2:2:1 ratio after first 100 patients .


Primary outcome measures were time to failure for guideline recommended goals of HbA1c and blood pressure over 12-months .


Of the 200 participants randomized , 89 % had diabetes and were similar in other cardiovascular risk factors .


After 1-year , the HbA1c failure rate was 0.36 [ 95 % CI , 0.28-0 .47 ] per quarter for the group medical visit arm , 0.24 [ 95 % CI , 0.18-0 .33 ] per quarter for the quarterly CRRC individual arm and , 0.82 [ 95 % CI , 0.69-0 .96 ] per quarter for the usual care control arm , p < 0.001 .


The rate of failure for blood pressure was 0.31 [ 95 % CI , 0.23-0 .41 ] per quarter for the group medical visit arm , 0.22 [ 95 % CI , 0.16-0 .30 ] per quarter for the CRRC individual arm and , 0.53 [ 95 % CI , 0.40-0 .71 ] per quarter the control arm , p < 0.001 .


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 1-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 2005-2010 were compared .


Children initiated ritonavir-boosted lopinavir ( LPV/r ) - based ART before 24 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 76 weeks post-randomization and then long-term follow up continued for a minimum of 99 weeks and maximum of 245 weeks after randomization .


Viral load , CD4 count , lipids , anthropometrics , drug concentrations , and adherence were measured at regular intervals .


Outcomes were compared between sexes within treatment strata .


A total of 323 children ( median age 8.8 months , IQR 5.1-13 .5 ) , including 168 boys and 155 girls , initiated LPV/r-based ART and 195 children were randomized .


No sex differences in risk of virological failure ( confirmed viral load > 1000 copies/mL ) by 156 weeks post-randomization were observed within either treatment group .


Girls switched to nevirapine had more robust CD4 count improvement relative to boys in this group through 112 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 3.4 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 .


ClinicalTrials.gov Identifier : NCT00117728 .


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 1 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 0.67 ( 95 % confidence interval [ CI ] , .48 , .94 ) and 0.74 ( 95 % CI , .55 , .99 ) , 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 = .04 and P = .02 , 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 3 groups : ( 1 ) website only , ( 2 ) website plus HCP support , or ( 3 ) usual care .


Patient-Oriented Eczema Measure ( POEM ) scores were measured online by carer report at baseline and at 12 weeks .


Qualitative interviews were carried out with 13 HCPs ( primarily practice nurses ) and 26 participants to explore their experiences of taking part in the study .


A total of 143 carers were recruited through 31 practices .


We found a decrease of 2 in follow-up compared with baseline POEM score in 23 of 42 ( 55 % ) participants in the website only group , 16 of 49 ( 33 % ) in the usual care group , and 18 of 47 ( 38 % ) in the website plus HCP group .


Website use data showed that 75 of 93 ( 81 % ) participants allocated to the website groups completed the core modules , but less than half used other key components ( videos : 35 % ; regular text reminders : 39 % ) .


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 .


International Standard Randomized Controlled Trial Number ( ISRCTN ) : 98560867 ; http://www.controlled-trials.com/ISRCTN98560867 ( Archived by WebCite at http://www.webcitation.org/6NcxvMtgN ) .


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 : NCT01673035 ) .


Participants ( n = 158 ) with a principal diagnosis of severe health anxiety were allocated to 12 weeks of exposure-based CBT ( n = 79 ) or BSM ( n = 79 ) 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 , 1.78 ; BSM , 1.22 ) .


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 3 trial comparing crizotinib with chemotherapy in 343 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 250 mg twice daily or to receive intravenous chemotherapy ( pemetrexed , 500 mg per square meter of body-surface area , plus either cisplatin , 75 mg per square meter , or carboplatin , target area under the curve of 5 to 6 mg per milliliter per minute ) every 3 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 , 10.9 months vs. 7.0 months ; hazard ratio for progression or death with crizotinib , 0.45 ; 95 % confidence interval [ CI ] , 0.35 to 0.60 ; P < 0.001 ) .


Objective response rates were 74 % and 45 % , respectively ( P < 0.001 ) .


Median overall survival was not reached in either group ( hazard ratio for death with crizotinib , 0.82 ; 95 % CI , 0.54 to 1.26 ; P = 0.36 ) ; the probability of 1-year survival was 84 % with crizotinib and 79 % 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 1014 ClinicalTrials.gov number , NCT01154140 . )


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 20 women undergoing elective cesarean delivery under epidural anesthesia were randomized to receive either 0.5 % levobupivacaine or 0.5 % racemic bupivacaine via an epidural catheter .


Immediately before and 30min , 1h , 2h , 6h , 12h and 24h 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 30min after epidural administration .


Concentrations of both agents showed constant and similar decreases in milk and plasma and were nearly undetectable at 24h .


The milk/plasma ratios were 0.340.13 for levobupivacaine and 0.370.14 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 8 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 ( 61 % vs 42.9 % , P < .001 ) , high-risk anatomic sites in women ( 88.6 % vs 46.5 % , P < .001 ) and men ( 92.1 % vs 34.8 % , P < .001 ) , and the ABCDEs of melanoma ( 98.4 % vs 91.2 % , P < .001 ) .


Students demonstrated increased confidence in the SCE ( 66.93 % vs 16.40 % , P < .001 ) and augmented intentions to practice it ( 99.05 % vs 13.9 % , P < .001 ) .


A greater proportion ( 70.4 % vs 41.9 % , P < .001 ) of students thought less than 3 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 65 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 12 weeks , with three sessions per week , building from 20 minute to 30 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 .


Australian New Zealand Clinical Trials Registry ACTRN12612001127897 .


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 25 patients each in arm A , B and arm C.


The mean baseline serum 25 - ( OH ) vitamin D content was 12.5 + / - 3.0 ( range , 2.5 to 19.5 ) ng/mL , with no statistical difference among the three arms .


Among 7 ( 9.33 % ) patients who developed definite acute cellular rejection ( Banff score > or = 6 ) , only 1 ( 4 % , 1/25 ) were from arm C while 6 ( 12 % , 6/50 ) of them were from either arm A or B.


The acute cellular rejection rate was 20 % ( 5/25 ) for arm C , 32 % ( 8/25 ) for arm A and 28 % ( 7/25 ) for arm B ( arm C vs. arm A or B , P < 0.05 ) .


Flow cytometric analysis showed that the proportion of circulating CD4 + CD25 ( high ) CD ( 127 - ) ( Treg ) cells in arm C increased by 63.22 % at one week post transplant ( 3.95 + / - 4.0 % ) compared to baseline ( 2.42 + / - 2.35 % ) ( P < 0.05 ) .


No significant difference was observed in arm A or B ( P > 0.05 in both vs. baseline ) .


Furthermore , no significant difference was noted among the three arms in the proportion of CD4 ( + ) CD45RA ( - ) CD45RO ( + ) , CD4 ( + ) CD25 ( low ) CD45RA ( + ) and CD4 ( + ) CD25 ( low ) CD45RA ( - ) 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 1 and 2 randomized , blinded , placebo-controlled study involving 65 patients with ischemic cardiomyopathy and left ventricular ( LV ) ejection fraction less than 50 % ( September 1 , 2009-July 12 , 2013 ) .


The study compared injection of MSCs ( n = 19 ) with placebo ( n = 11 ) and BMCs ( n = 19 ) with placebo ( n = 10 ) , with 1 year of follow-up .


Injections in 10 LV sites with an infusion catheter .


Treatment-emergent 30-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 30 .


The 1-year incidence of serious adverse events was 31.6 % ( 95 % CI , 12.6 % to 56.6 % ) for MSCs , 31.6 % ( 95 % CI , 12.6 % -56.6 % ) for BMCs , and 38.1 % ( 95 % CI , 18.1 % -61.6 % ) for placebo .


Over 1 year , the Minnesota Living With Heart Failure score improved with MSCs ( -6.3 ; 95 % CI , -15.0 to 2.4 ; repeated measures of variance , P = .02 ) and with BMCs ( -8.2 ; 95 % CI , -17.4 to 0.97 ; P = .005 ) but not with placebo ( 0.4 ; 95 % CI , -9.45 to 10.25 ; P = .38 ) .


The 6-minute walk distance increased with MSCs only ( repeated measures model , P = .03 ) .


Infarct size as a percentage of LV mass was reduced by MSCs ( -18.9 % ; 95 % CI , -30.4 to -7.4 ; within-group , P = .004 ) but not by BMCs ( -7.0 % ; 95 % CI , -15.7 % to 1.7 % ; within-group , P = .11 ) or placebo ( -5.2 % ; 95 % CI , -16.8 % to 6.5 % ; within-group , P = .36 ) .


Regional myocardial function as peak Eulerian circumferential strain at the site of injection improved with MSCs ( -4.9 ; 95 % CI , -13.3 to 3.5 ; within-group repeated measures , P = .03 ) but not BMCs ( -2.1 ; 95 % CI , -5.5 to 1.3 ; P = .21 ) or placebo ( -0.03 ; 95 % CI , -1.9 to 1.9 ; P = .14 ) .


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 .


clinicaltrials.gov Identifier : NCT00768066 .


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 = 1 , 268 ) were assigned to the combination of medication and psychosocial intervention or treatment as usual for up to 12 months .


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


Quality-adjusted life year ( QALY ) ratings were assessed with Short - Form 6D .


Average monthly psychosocial intervention costs for combined treatment were higher than treatment as usual ( p = 0.005 ) , but no significant differences were found in direct costs , indirect costs , and total costs between two groups ( all p-values 0.556 ) .


Combined treatment was associated with significant higher QALY ratings than treatment as usual ( p = 0.039 ) .


Compared with treatment as usual , combined treatment resulted in a gain of 0.031 QALY ratings at an additional cost of US$ 56.4 , yielding an incremental cost-effectiveness ratio of US$ 1819.4 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 .


clinicaltrials.gov Identifier : NCT00654576 .


To evaluate T1-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 1.5 T magnetic resonance ( MR ) system using relaxivity-adjusted doses of gadobutrol ( 0.15 mmol/kg ) and Gd-DTPA ( 0.2 mmol/kg ) in random order .


T1-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 ( < 0.05 ) .


Within 3 min of contrast agent administration ( CA ) , IM showed significantly lower T1-relaxation times than RM with both contrast agents , indicating beginning cardiac late enhancement .


Differences between gadobutrol and Gd-DTPA in T1-relaxation times of IM and RM were statistically not significant through all time points .


However , gadobutrol led to significantly higher T1-relaxation times of LVC than Gd-DTPA from 6 to 9 min ( 220 15 ms vs. 195 30 ms p < 0.01 ) onwards , resulting in a significantly greater T1 of IM to LVC at 9-12 min ( -20 35 ms vs. 0 35 ms , p < 0.05 ) and 12-15 min ( -25 45 ms vs. -10 60 ms , p < 0.05 ) .


Using Gd-DTPA , comparable T1 values were reached only after 25-35 min .


This study indicates good delineation of IM to RM with both contrast agents as early as 3 min after administration .


However , we found significant differences in T1 relaxation times with greater T1 IM-LVC using 0.15 mmol/kg gadobutrol compared to 0.20 mmol/kg Gd-DTPA after 9-15 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 1427 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 , 96 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 5 nerves ( median , ulnar , radial , medial cutaneous nerve of the forearm , and musculocutaneous ) measured at 5 , 10 , 15 , and 20 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 20 % to 31 % higher in the TI group than in the SI group at 10 , 15 , and 20 minutes after injection ( all P < 0.035 ) .


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 < 0.026 ) .


The average time needed to perform the block was significantly longer in the TI than the SI group ( 6.5 2.1 vs 4.7 2.1 minutes , P = 0.001 ) .


The overall success of surgical anesthesia measured at 30 minutes did not differ significantly between the 2 groups ( 96 % in TI vs 87 % in SI , P = 0.253 ) .


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 20 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 ( 18 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 ( 90 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 19-9 ) , 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 .


The POUDER trial has been registered at ClinicalTrials.gov with an ID NCT01879878 and WHO with an ID U1111-1144-2013 on June 13th 2013 .


This study aimed to test the hypothesis that high-dose prednisolone ( 4 mg/kg/day ) may be more efficacious than usual-dose ( 2 mg/kg/day ) prednisolone for spasm resolution at 14-days in children with infantile spasms .


This was a randomized , open-label-trial conducted at a tertiary-level-hospital from February-2012 to March-2013 .


Children aged 3-months to 2-years presenting with infantile spasms in clusters ( at least 1 cluster/day ) with hypsarrhythmia or its variants on EEG were enrolled .


The study participants were randomized to receive either high-dose prednisolone ( 4 mg/kg/day ) or the usual-dose ( 2 mg/kg/day ) prednisolone .


The primary outcome measure was the proportion of children who achieved spasm freedom for 48-h at day-14 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 : NCT01575639 ) .


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


The proportion of children with spasm cessation on day-14 was significantly higher in the high-dose group as compared to the usual-dose group ( 51.6 % vs. 25 % , p = 0.03 ) .


The absolute risk reduction was 26.6 % ( 95 % confidence interval 11.5-41 .7 % ) with number needed to treat being 4 .


The adverse effects were comparable in both the groups .


High-dose prednisolone ( 4 mg/kg/d ) was more effective than low-dose prednisolone ( 2mg/kg/d ) in achieving spasm cessation at 14-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 388 respondents , 296 questionnaires were eligible for analysis .


Mean age of respondents was 62.9 years .


Overall , 56 % ( n = 165 ) had ED , with up to 86 % in patients with heart failure .


Mean bother experienced due to ED was 5.93 ( 2.57 ) on a 0 to 10 scale .


Most respondents indicated to feel comfortable discussing sexual health with the cardiologists ( 88 % ) .


Of men with ED ( n = 165 ) , 46 % would like to have a conversation with the cardiologist about possibilities to improve sexual function , 55 % would be helped if questions could be asked during consultation with a specialized nurse , and 58 % would appreciate written information .


Of all respondents ( n = 296 ) , 28 % ever tried a phosphodiesterase inhibitor ; 4 % 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 120 individuals who have either : ( 1 ) been diagnosed with severe , irreversible sight loss , or ( 2 ) registered as blind or partially sighted within the last 3months .


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 3 , 6 , and 9months after recruitment and assignment to intervention or control group .


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


5-Reductase ( 5R ) types 1 and 2 catalyze the A-ring reduction of steroids , including androgens and glucocorticoids .


5-R inhibitors lower dihydrotestosterone in benign prostatic hyperplasia ; finasteride inhibits 5R2 , and dutasteride inhibits both 5R2 and 5R1 .


In rodents , loss of 5R1 promotes fatty liver .


Our objective was to test the hypothesis that inhibition of 5R1 causes metabolic dysfunction in humans .


This double-blind randomized controlled parallel group study at a clinical research facility included 46 men ( 20-85 years ) studied before and after intervention .


Oral dutasteride ( 0.5 mg daily ; n = 16 ) , finasteride ( 5 mg daily ; n = 16 ) , or control ( tamsulosin ; 0.4 mg daily ; n = 14 ) was administered for 3 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 -5.7 [ 3.2 ] mol/kg fat-free mass/min , versus finasteride +7.2 [ 3.0 ] , and tamsulosin +7.0 [ 2.0 ] ) .


Dutasteride also reduced suppression of nonesterified fatty acids by insulin and increased body fat ( by 1.6 % [ 0.6 % ] ) .


Glucose production and glycerol turnover were unchanged .


Consistent with metabolic effects of dutasteride being mediated in peripheral tissues , mRNA for 5R1 but not 5R2 was detected in human adipose tissue .


Dual inhibition of 5Rs , but not inhibition of 5R2 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-1 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 ( P4 ) 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 = 10 ) or a well-fed group ( WF , n = 9 ) .


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 53 % lower than group WF .


Insulin and IGF-1 concentrations were higher in WF than in R mares .


GH and IGF-2 concentrations were lower in plasma from WF mares than from R mares , but the difference was not significant in FF .


The IGFBP-2 / IGFBP-3 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 , P4 concentrations were not affected by feeding but were higher in preovulatory FF than in plasma .


The bioavailability of IGF-1 or IGF-2 , represented by the IGFBP2/IGFBP3 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 TRC150094 , a thyroid hormone mimetic .


This 4-week , randomized , placebo-controlled , double-blind trial was conducted in India and The Netherlands .


Forty subjects were randomized at a 1:1 ratio to receive either TRC150094 dosed at 50 mg or placebo once daily for 4 weeks .


Hyperinsulinemic euglycemic clamp and ( 1 ) H-Magnetic Resonance Spectroscopy ( MRS ) were performed before and after treatment .


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


TRC150094 dosed 50 mg once daily was safe and well tolerated .


Hepatic nor peripheral insulin sensitivity improved after TRC150094 treatment , expressed as the suppression of Endogenous Glucose Production from 59.5 to 62.1 % ; p = 0.477 , and the rate of glucose disappearance from 28.8 to 26.4 mol kg ( -1 ) min ( -1 ) , p = 0.185 .


TRC150094 administration did not result in differences in fasting plasma free fatty acids from 0.51 to 0.51 mmol/L , p = 0.887 or in insulin-mediated suppression of lipolysis from 57 to 54 % , p = 0.102 .


Also , intrahepatic triglyceride content was unaltered .


Collectively , these data show that , in contrast to the potent metabolic effects in experimental models , TRC150094 at a dose of 50 mg daily does not improve the metabolic homeostasis in subjects at an increased cardiometabolic risk .


Further studies are needed to evaluate whether TRC150094 has beneficial effects in patients with more severe metabolic derangement , such as overt diabetes mellitus and hypertriglyceridemia .


clinicaltrials.gov NCT01408667 .


We previously observed that 30 months of inhaled corticosteroid ( ICS ) treatment can attenuate FEV1 decline in COPD , but it is unclear whether withdrawal induces a relapse .


We hypothesized that FEV1 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 6-month or 30-month treatment with fluticasone ( 500 g bid ) , 30-month treatment with fluticasone and salmeterol ( 500/50 g bid ) , or placebo ( first part of the Groningen and Leiden Universities Corticosteroids in Obstructive Lung Disease [ GLUCOLD ] study [ GL1 ] ) .


The subsequent 5 years , patients were prospectively followed annually , treated by their physician ( GLUCOLD follow-up study [ GL2 ] ) .


Postbronchodilator FEV1 , AHR , and QOL were initially recorded at baseline , at 30 months ( GL1 ) , and annually during GL2 .


Analysis was performed by linear mixed-effects models .


Among 101 adherent patients during GL1 , 79 patients started and 58 completed GL2 .


Patients using ICSs during GL1 , but only using ICSs 0 % to 50 % of the time during GL2 ( n = 56 of 79 ) , had significantly accelerated annual FEV1 decline compared with GL1 ( difference GL2-GL1 [ 95 % CI ] : 30-month treatment with fluticasone and salmeterol , -68 mL/y [ -112 to -25 ] , P = .002 ; 30-month treatment with fluticasone , -73 mL/y [ -119 to -26 ] , P = .002 ) , accompanied by deterioration in AHR and QOL .


ICS discontinuation after 30 months in COPD can worsen lung function decline , AHR , and QOL during 5-year follow-up .


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


ClinicalTrials.gov ; No. : NCT00158847 ; URL : www.clinicaltrials.gov .


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 1985 and 1990 in Qidong , China , included 39,292 newborns who were randomly assigned to the vaccination group in which 38,366 participants completed the HBV vaccination series and 34,441 newborns who were randomly assigned to the control group in which the participants received neither a vaccine nor a placebo .


However , 23,368 ( 67.8 % ) participants in the control group received catch-up vaccination at age 10-14 years .


By December 2013 , a total of 3,895 ( 10.2 % ) in the vaccination group and 3,898 ( 11.3 % ) 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 31 , 2013 .


Two cross-sectional surveys on HBV surface antigen ( HBsAg ) seroprevalence were conducted in 1996-2000 and 2008-2012 .


The participation rates of the two surveys were 57.5 % ( 21,770 ) and 50.7 % ( 17,204 ) in the vaccination group and 36.3 % ( 12,184 ) and 58.6 % ( 17,395 ) 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 84 % ( 95 % CI 23 % -97 % ) , 70 % ( 95 % CI 15 % -89 % ) , and 69 % ( 95 % CI 34 % -85 % ) , respectively .


The estimated efficacy of catch-up vaccination on HBsAg seroprevalence in early adulthood was 21 % ( 95 % CI 10 % -30 % ) , substantially weaker than that of the neonatal vaccination ( 72 % , 95 % CI 68 % -75 % ) .


Receiving a booster at age 10-14 years decreased HBsAg seroprevalence if participants were born to HBsAg-positive mothers ( hazard ratio [ HR ] = 0.68 , 95 % CI 0.47-0 .97 ) .


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 75mg twice daily for 5 days or placebo , in addition to the standard pain care regimen .


There was no statistically significant difference in the primary outcome of 10 % 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 1 and 2 .


The pregabalin group required an average of 1.7 doses of rescue medications on postoperative day 1 versus 2.4 doses in the placebo group , and 1.7 doses versus 2.6 doses on postoperative day 2 ( P < 0.05 ) .


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 13 vaccine , recently registered in South Africa .


In a blinded randomized controlled field trial , 404 animals ( 85 cattle , 168 sheep , and 151 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 13 and the other given placebo .


Groups B included animals in 1st half of pregnancy , and group C animals in 2nd 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 14 , 28 , 56 , 183 and 365 .


In vaccinated goats ( N = 72 ) , 72 % developed anti-RVF virus IgM antibodies and 97 % neutralizing IgG antibodies .


In vaccinated sheep ( N = 77 ) , 84 % developed IgM and 91 % neutralizing IgG antibodies .


Vaccinated cattle ( N = 42 ) did not develop IgM antibodies but 67 % developed neutralizing IgG antibodies .


At day 14 post-vaccination , the odds of being seropositive for IgG in the vaccine group was 3.6 ( 95 % CI , 1.5 - 9.2 ) in cattle , 90.0 ( 95 % CI , 25.1 - 579.2 ) in goats , and 40.0 ( 95 % CI , 16.5 - 110.5 ) 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 13 vaccine is safe to use and has high ( > 90 % ) immunogenicity in sheep and goats but moderate ( > 65 % ) 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-3 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 12-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-3 PUFA in preventing relapses .


A randomized placebo-controlled one-center trial will be used to compare the efficacy of 26-week intervention , composed of either 1320mg/day of EPA and 880mg/day of DHA , or olive oil placebo with regard to symptom severity and relapse rate in first-episode schizophrenia patients .


Eighty-two patients ( aged 16-35 ) 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 26-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-3 PUFA and correlates of change , and contribute to the improvement of mental health care for individuals suffering from schizophrenia .


This study has been registered at Clinical Trials.gov with the following number : NCT02210962 .


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


From April to October 2011 , 60 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 4 hours preoperatively .


The 500 ml carbohydrate or placebo were administrated orally 2-3 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 3 % 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 48 patients ( 34 males and 14 females ) completed the trial .


The 24 and 24 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 12.68 3.13 , ( 1458 169 ) kcal/d , 0.73 0.42 , ( 0.53 0.24 ) g/L and 1.14 0.33 , respectively .


And the above items were 5.67 1.40 , ( 1341 110 ) kcal/d , 0.79 0.22 , ( 1.04 0.97 ) g/L and 0.92 0.19 in oral carbohydrate groups respectively .


All difference was statistically significant ( t = 6.646 , 2.851 , 6.546 , 2.542 and 2.730 , all P < 0.05 ) .


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 2007 to January 2012 ( analysis , Spring 2012 ) .


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


Included participants were aged 50-79 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 12 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 70.3 % ( 701 ) .


Most participants ( 83 % ) were Latino , Asian , or black .


Most had income < $ 30,000 ( 96 % ) and public health insurance ( 86 % ) .


Higher trust in PCP was associated with screening completion ( OR = 1.11 , 95 % CI = 1.03 , 1.17 ) , but trust in doctors was not ( OR = 1.02 , 95 % CI = 0.82 , 1.28 ) .


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 28 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 ( 5,000 IU vitamin A/kg/day vs. placebo ) for 28 days in ELBW neonates requiring mechanical ventilation , noninvasive ventilatory support or supplemental oxygen at 24 h of age .


The primary end point is the proportion of children who died before 36 weeks ' gestational age or developed moderate or severe BPD .


BPD is defined as the need for supplemental oxygen to maintain SaO2 of 92 % at rest at 36 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 36 weeks ' PMA in ELBW infants .


Research on the role of nutrition in type 2 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 15 adult patients with a medical diagnosis of type 2 diabetes mellitus with or without medication and with an increased waist circumference ( 80cm for women and94cm 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 .


This trial was registered at clinicaltrials.gov as NCT01891955 and Spanish Agency of Medication and Sanitary Products ( AEMPS ) registration code : MFV-ADI-2013-01 .


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 , 56 individuals with major depressive disorder were treated with curcumin ( 500 mg twice daily ) or placebo for 8 weeks .


The primary measure was the Inventory of Depressive Symptomatology self-rated version ( IDS-SR30 ) .


Secondary outcomes included IDS-SR30 factor scores and the Spielberger State-Trait Anxiety Inventory ( STAI ) .