The primary efficacy endpoint was reduction in Hamilton Anxiety Scale ( HAM-A ) total scores from baseline after 8weeks of treatment .


Key secondary outcomes were changes from baseline in HAM-A total scores for the 2.5 and 10mg dose , Hospital Anxiety and Depression anxiety subscore , 36-Item Short-Form Health Survey , Sheehan Disability Scale , and Clinical Global Impression-Improvement Scale score , as well as HAM-A response rate at week 8 .


Neither vortioxetine dose achieved a statistically significant improvement over placebo on the primary endpoint ( least-squares mean differencestandard error from placebo : -0.870.803 [ p = 0.279 ] for 2.5 mg and -0.810.791 [ p = 0.306 ] for 10mg vortioxetine ) or on any secondary efficacy endpoints .


Common adverse events ( 5 % in either vortioxetine group ) were nausea , dry mouth , headache , diarrhea , constipation , and vomiting .


Vortioxetine 2.5 and 10mg treatment did not significantly improve generalized anxiety disorder symptoms versus placebo .


Vortioxetine was safe and well tolerated in this patient population .


In acute stroke , the volume of salvageable brain tissue is maximal at onset and declines rapidly with time .


Prehospital start of clinical trial interventions would enable delivery of neuroprotective agents , such as magnesium sulfate , to stroke patients in the hyperacute period when they are potentially most effective .


A broad aim of the FAST-MAG study is to develop and validate techniques to perform pivotal trials of neuroprotective therapies for acute stroke in the prehospital setting .


In tandem with an accompanying general trial design article , this manuscript provides a detailed overview of several novel prehospital study methods employed in the NIH FAST-MAG Trial .


Multicenter , randomized , double-blinded , placebo-controlled , pivotal clinical trial .


Special Prehospital Procedures Distinctive prehospital methods deployed in FAST-MAG include : identifying likely stroke patients using the Los Angeles Prehospital Stroke Screen ; eliciting explicit informed consent from patients or on scene legally authorized representatives via cellphone discussion with off-scene physicians ; paramedic rating of pretreatment stroke severity using the Los Angeles Motor Scale ; assigning patients to a study arm using blinded , pre-encounter randomization ; facilitating continuity of study infusion from the field to the ED by stocking ambulances with study kits including both field and hospital doses ; and electronic fax consent signature documentation by geographically separated subjects and enrolling physicians .


The suite of prehospital trial methods developed for the FAST-MAG Trial enable enrollment of patients in very early time windows , including the hyperacute , ` golden hour ' period immediately after stroke onset .


The development of periarticular thickening of skin on the hands and limited joint mobility ( cheiroarthropathy ) is associated with diabetes and can lead to significant disability .


The objective of this study was to describe the prevalence of cheiroarthropathy in the well-characterized Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications ( DCCT/EDIC ) cohort and examine associated risk factors , microvascular complications , and the effect of former DCCT therapy ( intensive [ INT ] vs. conventional [ CONV ] ) on its development .


This cross-sectional analysis was performed in 1,217 participants ( 95 % of the active cohort ) in EDIC years 18/19 after an average of 24 years of follow-up .


Cheiroarthropathy-defined as the presence of any one of the following : adhesive capsulitis , carpal tunnel syndrome , flexor tenosynovitis , Dupuytren 's contracture , or a positive prayer sign-was assessed using a targeted medical history and standardized physical examination .


A self-administered questionnaire ( Disabilities of the Arm , Shoulder and Hand [ DASH ] ) assessed functional disability .


Cheiroarthropathy was present in 66 % of subjects ( 64 % of the INT group and 68 % of the CONV group ; P = 0.1640 ) and was associated with age , sex , diabetes duration , skin intrinsic fluorescence , HbA1c , neuropathy , and retinopathy ( P < 0.005 for each ) .


DASH functional disability scores were worse among subjects with cheiroarthropathy ( P < 0.0001 ) .


Cheiroarthropathy is common in people with type 1 diabetes of long duration ( 30 years ) and is related to longer duration and higher levels of glycemia .


Clinicians should include cheiroarthropathy in their routine history and physical examination of patients with type 1 diabetes because it causes clinically significant functional disability .


The present research examined the effects of a mindfulness-based intervention to foster healthy eating .


Specifically , we tested whether a brief mindfulness manipulation can prevent the portion size effect , and reduce overeating on unhealthy snacks when hungry .


110 undergraduate participants ( MAge = 20.92.3 ; MBMI = 22.32.5 ) were served a small or a large portion of chocolate chip cookies after listening to an audio book or performing a mindfulness exercise ( i.e. , body scan ) .


Current level of hunger was assessed unobtrusively on a visual analog scale before the eating situation .


Calorie intake from chocolate chip cookies .


When presented with a large compared to a small portion , participants consumed more cookies ( +83 kcal ) .


This was not affected by the mindfulness intervention or by hunger .


However , while control participants ate more unhealthy food when hungry than when not hungry ( +67 kcal ) , participants in the mindfulness condition did not ( +1 kcal ) .


Findings confirm the prevalence and robustness of the portion size effect and suggest that it may be independent from awareness of internal cues .


Prevention strategies may benefit more from targeting awareness of the external environment .


However , mindfulness-based interventions may be effective to reduce effects of hunger on unhealthy food consumption .


This study aimed to investigate the potential use of icotinib as first-line treatment to prevent brain metastasis from advanced lung adenocarcinoma .


This investigation was designed as a retrospective nonrandomized controlled study .


Enrolled patients received either icotinib or traditional chemotherapy as their first-line treatment .


The therapeutic efficacy was compared among patients with advanced ( stages IIIB and IV ) lung adenocarcinoma with epidermal growth factor receptor ( EGFR ) - sensitive mutation .


The primary endpoint was the cumulative incidence of brain metastasis , whereas the secondary endpoint was overall survival ( OS ) .


Death without brain metastasis was considered a competitive risk to calculate the cumulative risk of brain metastasis .


Survival analysis was conducted using the Kaplan-Meier method and statistical significance were determined using the log-rank test .


The present study included 396 patients with 131 in the icotinib group and 265 in the chemotherapy group .


Among those with EGFR-sensitive mutation , the cumulative risk of brain metastasis was lower in the icotinib group than in the chemotherapy group .


However , no significant difference in OS was observed between the two groups .


Icotinib can effectively reduce the incidence of brain metastasis and therefore improve prognosis in advanced lung adenocarcinoma patients with EGFR-sensitive mutation .


Many people with suicidal thoughts do not receive treatment .


The Internet can be used to reach more people in need of support .


To test the effectiveness of unguided online self-help to reduce suicidal thoughts .


236 adults with mild to moderate suicidal thoughts were randomised to the intervention ( n = 116 ) or a waitlist control group ( n = 120 ) .


Assessments took place at baseline , and 2 , 4 and 6 weeks later .


Primary outcome was suicidal thoughts .


Secondary outcomes were depressive symptoms , anxiety , hopelessness , worry , and health status .


The intervention group showed a small significant effect in reducing suicidal thoughts ( d = 0.28 ) .


Effects were more pronounced for those with a history of repeated suicide attempts .


There was also a significant reduction in worry ( d = 0.33 ) .


All other secondary outcomes showed small but non-significant improvements .


Although effect sizes were small , the reach of the internet could enable this intervention to help many people reduce their suicidal thoughts .


Netherlands Trial Register NTR1689 .


Matrix metalloproteinase-2 and -9 , known as gelatinases , are considered to be essential for tissue remodelling during the reproductive process .


However , their role in reproduction is unclear .


In the present study , we aimed to investigate the relationship between follicular fluid gelatinase levels and oocyte quality and fertilization , and to compare the activities of gelatinase levels with different drug stimulation protocols .


We evaluated 60 women with unexplained infertility who underwent in vitro fertilization ( IVF ) treatment .


Thirty patients underwent a gonadotropin-releasing hormone ( GnRH ) agonist protocol and 30 underwent a GnRH antagonist protocol .


Follicular fluid was obtained during oocyte retrieval .


Oocyte quality was determined using light microscopy , and oocytes were considered to be fertilized when two pronuclei were present .


Gelatinase activities were measured using commercial enzyme-linked immunosorbent assay kits .


The study was partially supported by the Scientific Research Unit of Suleyman Demirel University ( Protocol Number : 3620-TU1-13 ) , and all procedures were conducted with the approval of the Suleyman Demirel University Local Ethics Board .


Statistical analyses of the data were performed using the independent t test , Fisher exact test , Mann-Whitney U test , one-way ANOVA , and posthoc least significant difference .


Follicular fluid gelatinase levels were significantly higher for agonist drug administration ( p = 0.001 ) , and a positive correlation was observed between matrix metalloproteinase-9 levels and oocyte grade ( p = 0.01 ) .


Moreover , a positive relationship between matrix metalloproteinase-9 levels and fertilization was observed ( p = 0.02 ) .


Follicular fluid gelatinase activities , particularly MMP-9 activity , might be a predictor of oocyte quality and IVF success .


Remifentanil is an ultrashort-acting synthetic opioid , and the metabolism of which is not influenced by hepatic or renal function .


This study aims to compare the efficacy of two remifentanil doses during procedures in ventilated preterm infants .


Prospective , randomized , double-blind , noninferiority trial .


Neonatal ICU .


Preterm infants who were supported by a mechanical ventilator with tracheal tube and requiring central venous access .


Two remifentanil dosages were administered in mechanically ventilated preterm infants during peripherally inserted central catheter insertion .


Fourteen preterm infants were randomly assigned to low-dose ( 0.1 g/kg/min ) or high-dose ( 0.25 g/kg/min ) remifentanil infusion .


The Premature Infant Pain Profile was used to score pain during the procedure , and changes in the Premature Infant Pain Profile score between needle puncture and baseline were analyzed to investigate the noninferiority of low-dose to high-dose remifentanil .


Occurrence of cardiorespiratory complications was also recorded .


The median gestational age ( minimum , maximum ) was 26 weeks ( 24 , 31 ) , and the median birth weight was 825 g ( 610 , 1,280 ) .


Changes in Premature Infant Pain Profile in the high-dose and low-dose groups were 1.43 3.10 and -0.60 5.32 , respectively .


The difference in changes in the Premature Infant Pain Profile score between the high-dose and low-dose groups was -2.03 4.13 .


The corresponding lower limit of one-tailed 97.5 % CI was -7.24 , below the noninferiority margin .


Apneic events and bradycardia did not occur in the low-dose group ; however , there were three episodes of apnea ( 42.9 % ) and one of bradycardia ( 14.3 % ) in the high-dose group ( p = 0.683 and 0.366 , respectively ) .


For mechanically ventilated preterm infants , the use of remifentanil at 0.25 g/kg/min as an analgesic for short procedures represents a therapeutic option .


Our pilot study suggests the need for larger randomized trials .


The objective of this study was to compare two different periodontal plastic surgery procedures to treat Miller 's class I recession : a coronally advanced flap ( control group ) versus the pouch technique ( test group ) , both of which were associated with connective tissue graft .


Forty consecutive patients were included , with 20 patients being allocated for each group .


The level of recession coverage , the keratinized tissue ( KT ) quantity , gingival aesthetics ( PES ) and post-operative outcomes were assessed for a follow-up period of 6 months .


After 6 months , both techniques allowed for the excellent mean root coverage of 96.3 plus/minus 12.1 % in the control group and of 91.3 plus/minus 17.6 % in the test group.Complete root coverage was achieved in 89.5 % ( 17/19 ) and 79 % ( 15/19 ) of the recession cases in the control and the test groups respectively .


A significant increase in KT height ( p = 0.0011 ) was observed in the test group .


A significant improvement in the pink aesthetic score was found in the two groups , but gingival texture displayed significantly better results in the test group ( p < 0.0001 ) .


No significant difference between the two groups was found in terms of the morbidity outcomes .


Pain killer consumption was similar in the two groups and significantly decreased over time .


Both surgical techniques are relevant in treating Miller 's class I recession .


The pouch technique seems to increase the height of KT better and provides good gingival-related aesthetic outcomes .


To explore the effects and mechanism of acupuncture at Zusanli ( ST 36 ) combined with oral administration of Gexia Zhuyu decoction on damp-heat ulcerative colitis at active phase .


One hundred and twenty cases of damp-heat ulcerative colitis at active phase , by using random draw method , were divided into an observation group and a control group , 60 cases in each one .


Patients in the control group were treated with basic treatment combined with oral administration of Gexia Zhuyu decoction .


Based on this , patients in the observation group were additionally treated with acupuncture at Zusanli ( ST 36 ) .


The treatment was given both for 14 days .


The efficacy , each symptom score , serum interleukin-1beta ( IL-1beta ) , interleukin-6 ( IL-6 ) and tumor necrosis factor-alpha ( TNF-alpha ) were observed .


( 1 ) After treatment , the total effective rate was 98.3 % ( 59/60 ) in the observation group , which was significantly higher than 86.7 % ( 52/60 ) in the control group ( P < 0.05 ) .


( The improvement rates of ulceration , edema , erosion and polyp in the observation group were obviously higher than those in the control group ( all P < 0.05 ) .


( 3 ) After treatment , the symptom scores of diarrhea , bloody purulent stool , abdominal pain , tenesmus as well as inflammatory factors of IL-1beta , IL-6 and TNF-alpha were all improved compared with those before treatment in the two groups ( all P < 0.05 ) ; the differences between the observation , group and control group were statistically significant ( all P < 0.05 ) .


( 4 ) During the 3-month follow up visit , the recurrence rate was 1.7 % ( 1/59 ) in the observation group , which was significantly lower than 11.5 % ( 6/52 ) in the control group ( P < 0.05 ) .


The Gexia Zhuyu decoction combined with acupuncture at Zusanli ( ST 36 ) could effectively improve efficacy , reduce recurrence rate , relieve clinical symptoms and prompt recovery of mucous membrane in patients with damp-heat ulcerative colitis at active phase , which is related with reducing the expression of inflammation .


To compare the incidence and intensity of posterior capsule opacification ( PCO ) between 2 similar 1-piece foldable hydrophobic acrylic intraocular lenses ( IOLs ) over 3 years .


Department of Ophthalmology , Medical University Vienna , Vienna , Austria .


Randomized prospective patient - and examiner-masked clinical trial with intraindividual comparison .


Patients with bilateral age-related cataract had cataract surgery and implantation of a Tecnis ZCB00 continuous-optic-edge IOL in 1 eye and an Acrysof SA60AT interrupted-optic-edge IOL in the other eye .


Postoperative examinations were performed at 6 months and 3 years .


Digital retroillumination images were taken of each eye .


The amount of PCO ( score 0 to 10 ) was assessed subjectively at the slitlamp and objectively using automated image-analysis software .


The study comprised 54 patients ( 108 eyes ) .


The mean objective PCO score was 1.3 1.7 ( SD ) for the continuous-optic-edge IOLs and 0.9 1.3 for the interrupted-optic-edge IOLs ( P = .10 ) .


Three years postoperatively , a neodymium : YAG ( Nd : YAG ) capsulotomy was performed in 26.1 % of eyes with the continuous-optic-edge IOL and 21.7 % with the interrupted-optic-edge IOL ( P = .56 ) .


There was no significant difference in corrected distance visual acuity , capsulorhexisIOL overlap , capsule folds , or anterior capsule opacification 3 years after surgery .


Both IOLs had comparable PCO and Nd : YAG rates 3 years postoperatively .


The optimized barrier function of the continuous-optic-edge IOL and the material properties of the interrupted-optic-edge IOL seemingly outbalanced the effect on lens epithelial cell migration and proliferation beneath the optic .


To use a cine balanced steady-state free precession magnetic resonance enterography ( cine MRE ) pulse sequence to assess the effectiveness of a sublingual ( SL ) antiperistaltic agent , hyoscyamine sulfate .


Institutional review board approval was granted with an exemption for informed consent in this Health Insurance Portability and Accountability Act-compliant , retrospective , single-institution study .


Of the 288MRE examinations performed between October 1 , 2007 and January 15 , 2011 , 92 using SL hyoscyamine sulfate for antiperistalsis were included for review , each with cine MRE before and after medication .


These 184 cine MRE data sets were randomized , blinded for treatment , and independently reviewed by five attending abdominal radiologists , who rated the degree of whole abdomen bowel motility on each cine MRE data set on a 5-point scale .


Pre - and postmedication mean peristalsis ratings , standard deviation , mean difference , and treatment effect sizes werecalculated .


A repeated measures analysis of variance test was performed using a significance threshold of P = .05 .


Interobserver reliabilities were also calculated .


Mean peristalsis ratings ranged 2.63-3 .34 and 2.36-3 .03 , before and after medication administration , respectively .


The mean differences ranged from 0.22 to 0.46 , which are treatment effect sizes of 0.20 to 0.37 .


The decrease in peristalsis observed by the five reviewing radiologists after SL hyoscyamine sulfate administration was significant ( df = 1/182 , f = 7.35 , P < .01 ) .


The interobserver reliabilities were 0.34 for the pretest and 0.33 for the posttest .


Although cine MRE sequences show decreased bowel peristalsis after the use of SL hyoscyamine sulfate , the small size ofthe observed treatment effect is likely insufficient to justify its use for MRE .


CONCERTO was a randomised , double-blind , parallel-armed study of methotrexate ( MTX ) in combination with adalimumab to assess whether an increasing trend of efficacy and decreased safety exists when increasing MTX dose in patients with early rheumatoid arthritis ( RA ) .


Early , biologic and MTX-naive RA patients ( N = 395 ) were evenly randomised to open-label adalimumab ( 40mg every other week ) plus weekly blinded 2.5 , 5 , 10 or 20mg MTX for 26weeks .


Clinical , radiographic and functional outcomes were analysed using two-sided linear trend tests or one-way analysis of covariance .


Statistically significant increasing trends were observed in the proportion of patients achieving the primary endpoint , 28-joint count disease activity score with C reactive protein ( DAS28 ( CRP ) ) < 3.2 ( 42.9 % , 44.0 % , 56.6 % and 60.2 % for 2.5 , 5 , 10 or 20mg/week MTX , respectively ) , DAS28 ( CRP ) < 2.6 and American College of Rheumatology 50/70/90 responses with increasing doses of MTX in combination with adalimumab .


No statistical differences in minimal clinically important differences in physical function were detected .


Statistically significant trends for achieving low disease activity and remission were demonstrated with increasing MTX dose by validated clinical indices ; differences comparing 10 and 20mg MTX were minimal .


Adalimumab serum concentrations increased with ascending dose up to 10mg MTX .


More patients experienced infectious adverse events with increasing MTX dose .


Increasing doses of MTX in combination with adalimumab demonstrated a statistically significant trend in improved clinical outcomes that mimicked the adalimumab pharmacokinetic profile .


In early RA patients initiating adalimumab combination therapy , efficacy of 10 and 20mg/week MTX appeared equivalent .


To compare transvaginal prolapse repair combined with midurethral sling ( MUS ) versus prolapse repair only .


Multi-centre randomised trial .


Fourteen teaching hospitals in the Netherlands .


Women with symptomatic stage two or greater pelvic organ prolapse ( POP ) , and subjective or objective stress urinary incontinence ( SUI ) without prolapse reduction .


Women were randomly assigned to undergo vaginal prolapse repair with or without MUS .


Analysis was according to intention to treat .


The primary outcome at 12 months ' follow-up was the absence of urinary incontinence ( UI ) assessed with the Urogenital Distress Inventory and treatment for SUI or overactive bladder .


Secondary outcomes included complications .


One hundred and thirty-four women were analysed at 12 months ' follow-up ( 63 in MUS and 71 in control group ) .


More women in the MUS group reported the absence of UI and SUI ; respectively 62 % versus 30 % UI ( relative risk [ RR ] 2.09 ; 95 % confidence interval [ CI ] 1.39-3 .15 ) and 78 % versus 39 % SUI ( RR 1.97 ; 95 % CI 1.44-2 .71 ) .


Fewer women underwent treatment for postoperative SUI in the MUS group ( 10 % versus 37 % ; RR 0.26 ; 95 % CI 0.11-0 .59 ) .


In the control group , 12 women ( 17 % ) underwent MUS after prolapse surgery versus none in the MUS group .


Severe complications were more common in the MUS group , but the difference was not statistically significant ( 16 % versus 6 % ; RR 2.82 ; 95 % CI 0.93-8 .54 ) .


Women with prolapse and co-existing SUI are less likely to have SUI after transvaginal prolapse repair with MUS compared with prolapse repair only .


However , only 17 % of the women undergoing POP surgery needed additional MUS .


A well-informed decision balancing risks and benefits of both strategies should be tailored to individual women .


To compare the postprandial plasma glucose level after diabetic specific formula ( DSF ) and standard formula ( SF ) administration in type 2 diabetic patients .


Thirty type 2 diabetic patients were included in the present randomized , controlled , double-blind , cross-over study .


Subjects received DSF and isocaloric SF as a bolus administration of 400 mL while continuing their anti-diabetic medications .


Venous blood samples were collected and analyzed to assess plasma glucose levels at pre - and at 30 , 60 , 90 , 120 , and 180 min post-administration of the formulas .


Postprandial glucose profiles were significantly lower with DSF compared to SF administration determined as a mean glucose concentration at 2-hour post-administration .


The glucose area under the curve ( AUC ) after DSF consumption was 33 % lower than the AUC after SF consumption , p < 0.001 .


Use of DSF resulted in a significantly lower postprandial rise in plasma glucose concentrations than using SF .


It should be the preferred option in diabetic patients who need nutritional support .


Irisin is a recently identified exercise-induced myokine .


However , the circulating levels of irisin in response to different types of exercise in subjects with metabolic syndrome are unknown .


This study aimed to study the levels of irisin in healthy males and subjects with metabolic syndrome at baseline and in response to exercise .


Each individual completed high-intensity interval exercise ( HIIE ) , continuous moderate-intensity exercise ( CME ) , and resistance exercise ( RE ) sessions in a random , crossover design .


Percentage change in circulating irisin levels was examined .


Two different irisin assays were used to compare the results of the RE study .


Circulating irisin increased immediately after HIIE , CME , and RE and declined 1 hour later .


The increase was greater in response to resistance compared with either high-intensity intermittent exercise or CME .


Change in irisin in response to exercise did not differ between individuals with and without metabolic syndrome .


Exercise is able to increase circulating irisin levels in individuals with the metabolic syndrome as well as healthy individuals .


Whether this increase may contribute to the beneficial effects of exercise on patients with the metabolic syndrome remains to be studied further .


Blacks receive live donor kidney transplant ( LDKT ) less often than patients of all other races .


We evaluated the effectiveness of educational interventions in removing barriers to LDKT for blacks .


Patients were randomized to three interventions in which health educator ( s ) delivered an intervention to ( a ) the patient and his/her guests in the patient 's home ( house calls [ HC ] , n = 54 ) , ( b ) clusters of patients and their guests in the transplant center ( group based [ GB ] , n = 49 ) , and ( c ) the individual patient alone in the transplant center ( individual counseling [ IC ] , n = 49 ) .


At the 2-year endpoint , 15 % ( n = 8 ) , 8 % ( n = 4 ) , and 6 % ( n = 3 ) of HC , GB , and IC patients , respectively , received LDKT ( P = 0.30 ) .


Patients in the HC group were more likely than patients in the GB and IC groups to have at least one donor inquiry ( 82 % vs. 61 % vs. 47 % , P = 0.001 ) and evaluation ( 65 % vs. 39 % vs. 27 % , P < 0.001 ) .


Patients in the HC group also were more likely to have higher knowledge , fewer concerns , and higher willingness to talk to others about donation 6 weeks after intervention .


These findings underscore the importance of including the patient 's social network in LDKT education and the potential of the HC intervention to reduce racial disparity in LDKT rates .


Shared decision making is a crucial component of evidence-based practice , but a lack of training in the `` how to '' of it is a major barrier to its uptake .


To evaluate the effectiveness of a brief intervention for facilitating shared decision making skills in clinicians and student clinicians .


Multi-centre randomized controlled trial .


One hundred and seven medical students , physiotherapy or occupational therapy students undertaking a compulsory course in evidence-based practice as part of their undergraduate or postgraduate degree from two Australian universities .


The 1-h small-group intervention consisted of facilitated critique of five-step framework , strategies , and pre-recorded modelled role-play .


Both groups were provided with a chapter about shared decision making skills .


The primary outcome was skills in shared decision making and communicating evidence [ Observing Patient Involvement ( OPTION ) scale , items from the Assessing Communication about Evidence and Patient Preferences ( ACEPP ) Tool ] , rated by a blinded assessor from videorecorded role-plays .


confidence in these skills and attitudes towards patient-centred communication ( Patient Practitioner Orientation Scale ( PPOS ) ) .


Of participants , 95 % ( 102 ) completed the primary outcome measures .


Two weeks post-intervention , intervention group participants scored significantly higher on the OPTION scale ( adjusted group difference = 18.9 , 95 % CI 12.4 to 25.4 ) , ACEPP items ( difference = 0.9 , 95 % CI 0.5 to 1.3 ) , confidence measure ( difference = 13.1 , 95 % CI 8.5 to 17.7 ) , and the PPOS sharing subscale ( difference = 0.2 , 95 % CI 0.1 to 0.5 ) .


There was no significant difference for the PPOS caring subscale .


This brief intervention was effective in improving student clinicians ' ability , attitude towards , and confidence in shared decision making facilitation .


Following further testing of the longer-term effects of this intervention , incorporation of this brief intervention into evidence-based practice courses and workshops should be considered , so that student clinicians graduate with these important skills , which are typically neglected in clinician training .


This randomised trial tested ( i ) whether a home-based expressive writing ( EW ) intervention improves quality of life in patients with colorectal cancer ( CRC ) and ( ii ) whether the intervention is more beneficial for men or for people who feel constrained in disclosing cancer-related concerns and feelings .


Patients treated for CRC were randomised to an EW ( n = 101 ) or control writing ( CW ; n = 92 ) group .


Assessments were completed at 1 month pre - and post-intervention .


Sex and perceived social constraints on disclosure were evaluated as moderators .


Primary outcomes were depressive symptoms , sleep problems and quality of life indicators .


Eighty-one per cent of participants completed all writing assignments .


Consistent with hypotheses , relative to the CW group , participants in the EW group expressed more negative emotion in writing and rated their writings as more meaningful , personal and emotionally revealing .


There were no significant main effects of EW or moderating effects of sex or social constraints on outcomes .


Although EW is feasible to use with persons who have CRC , it was not effective as a stand-alone psychotherapeutic intervention .


Neither was it more effective for men nor for people who felt they could not freely disclose cancer-related concerns and feelings .


Ideal fluid management during surgery still poses a clinical dilemma gauging the benefits and adverse effects .


This randomized controlled trial compared the tissue perfusion and coagulation profiles under clinically equivalent hydroxyethyl starch ( HES 130/0 .4 ) and lactated Ringer 's solution ( LR ) .


Eighty-four patients undergoing major abdominal surgery were randomized to receive either HES or LR .


Tissue perfusion parameters using heart rate , arterial blood pressure , central venous pressure , cardiac index , stroke volume index , and central venous oxygen saturation were measured at T0 ( baseline ) , T1 ( start of surgery ) , T2 ( 1 hour after start of surgery ) , and T3 ( end of surgery ) .


Coagulation parameters using thrombelastography ( TEG ) were measured at T0 ( baseline ) , T4 ( after 15mL/kg fluid transfused ) , and T5 ( 24 hours after baseline ) .


The total amount of fluid administrated was 1547.9424.0 mL in HES group and 2303.11033.7 mL in LR group ( p < 0.001 ) .


The parameters of tissue perfusion and TEG did not differ significantly between groups at any time point except for a transient decrease in clot kinetic and clot strength at T4 for HES group .


There was no significant difference in blood loss and consumption of blood products between the two fluids .


HES 130/0 .4 is a more efficient intravascular volume expander to maintain tissue perfusion than conventional crystalloid .


Transient hypocoagulability induced by HES 130/0 .4 does not warrant excessive blood loss and blood transfusion .


To determine the relationship between host immunity and the characteristics of viral infection or nucleoside analogues ( NAs ) themselves in patients with chronic hepatitis B ( CHB ) receiving NA therapy .


Fifty-two hepatitis B envelope antigen ( HBeAg ) positive CHB patients were enrolled and divided equally into two groups .


One group received telbivudine ( LDT , 600 mg/d ) , and the other group received lamivudine ( LAM , 100 mg/d ) .


Clinical , virological and immunological parameters were assessed at the baseline and at 4 , 12 , 24 , 36 and 48 wk .


Both groups achieved significant hepatitis B virus ( HBV ) replication inhibition and alanine aminotransferase normalization at 48 wk .


At the baseline , compared to healthy controls , CHB patients had a lower circulating CD8 T cell frequency ( 29.44 % 11.55 % vs 37.17 % 7.30 % , P = 0.03 ) and higher frequencies of programmed death 1 positive CD8 T cells ( PD-1 + CD8 T ) ( 16.48 % 10.82 % vs 7.02 % 3.62 % , P = 0.0001 ) and CD4 + CD25 + FoxP3 + T regulatory cells ( Tregs ) ( 23.64 % 9.38 % vs 13.60 % 6.06 % , P = 0.001 ) .


On therapy , at the beginning 24 wk with the levels of hepatitis B virus deoxyribonucleic acid ( HBV DNA ) and HBeAg declining , the frequencies of PD-1 + CD8 T cells and Treg cells gradually and significantly declined at 12 and 24 wk in both therapy groups .


At treatment week 4 , patients treated with LDT had a lower frequency of PD-1 + CD8 T cells compared to patients treated with LAM ( 10.08 % 6.83 % vs 20.51 % 20.96 % , P = 0.02 ) .


The frequency of PD-1 + CD8 T cells in all of the CHB patients was significantly correlated with both the HBV DNA level ( r = 0.45 , P = 0.01 ) and HBeAg level ( r = 0.47 , P = 0.01 ) at treatment week 24 , but the frequency of Treg cells was only significantly correlated with the HBeAg level ( r = 0.44 , P = 0.02 ) .


Furthermore , the ability of CD8 T cells to secrete pro-inflammatory cytokines was partially restored after 24 wk of therapy .


NA-mediated HBV suppression could down-regulate the production of negative regulators of host immunity during the first 24 wk of therapy and could partially restore the ability of CD8 T cells to secrete pro-inflammatory cytokines .


This immune modulating response may be correlated with the levels of both HBV DNA and HBeAg .


Patient-centered medical homes have not been shown to reduce adverse outcomes or costs in adults or children with chronic illness .


To assess whether an enhanced medical home providing comprehensive care prevents serious illness ( death , intensive care unit [ ICU ] admission , or hospital stay > 7 days ) and/or reduces costs among children with chronic illness .


Randomized clinical trial of high-risk children with chronic illness ( 3 emergency department visits , 2 hospitalizations , or 1 pediatric ICU admissions during previous year , and > 50 % estimated risk for hospitalization ) treated at a high-risk clinic at the University of Texas , Houston , and randomized to comprehensive care ( n = 105 ) or usual care ( n = 96 ) .


Enrollment was between March 2011 and February 2013 ( when predefined stopping rules for benefit were met ) and outcome evaluations continued through August 31 , 2013 .


Comprehensive care included treatment from primary care clinicians and specialists in the same clinic with multiple features to promote prompt effective care .


Usual care was provided locally in private offices or faculty-supervised clinics without modification .


Primary outcome : children with a serious illness ( death , ICU admission , or hospital stay > 7 days ) , costs ( health system perspective ) .


Secondary outcomes : individual serious illnesses , medical services , Medicaid payments , and medical school revenues and costs .


In an intent-to-treat analysis , comprehensive care decreased both the rate of children with a serious illness ( 10 per 100 child-years vs 22 for usual care ; rate ratio [ RR ] , 0.45 [ 95 % CI , 0.28-0 .73 ] ) , and total hospital and clinic costs ( $ 16,523 vs $ 26,781 per child-year , respectively ; cost ratio , 0.58 [ 95 % CI , 0.38-0 .88 ] ) .


In analyses of net monetary benefit , the probability that comprehensive care was cost neutral or cost saving was 97 % .


Comprehensive care reduced ( per 100 child-years ) serious illnesses ( 16 vs 44 for usual care ; RR , 0.33 [ 95 % CI , 0.17-0 .66 ] ) , emergency department visits ( 90 vs 190 ; RR , 0.48 [ 95 % CI , 0.34-0 .67 ] ) , hospitalizations ( 69 vs 131 ; RR , 0.51 [ 95 % CI , 0.33-0 .77 ] ) , pediatric ICU admissions ( 9 vs 26 ; RR , 0.35 [ 95 % CI , 0.18-0 .70 ] ) , and number of days in a hospital ( 276 vs 635 ; RR , 0.36 [ 95 % CI , 0.19-0 .67 ] ) .


Medicaid payments were reduced by $ 6243 ( 95 % CI , $ 1302 - $ 11,678 ) per child-year .


Medical school losses ( costs minus revenues ) increased by $ 6018 ( 95 % CI , $ 5506 - $ 6629 ) per child-year .


Among high-risk children with chronic illness , an enhanced medical home that provided comprehensive care to promote prompt effective care vs usual care reduced serious illnesses and costs .


These findings from a single site of selected patients with a limited number of clinicians require study in larger , broader populations before conclusions about generalizability to other settings can be reached .


clinicaltrials.gov Identifier : NCT02128776 .


To compare the effect of 7 h of prolonged sitting on resting blood pressure with a similar duration of sitting combined with intermittent brief bouts of light-intensity or moderate-intensity physical activity .


Overweight/obese adults ( n = 19 ; aged 45-65 years ) were recruited for a randomized three-treatment crossover trial with a one-week washout between treatments : 1 ) uninterrupted sitting ; 2 ) sitting with 2 min bouts of light-intensity walking at 3.2 km/h every 20 min ; and , 3 ) sitting with 2 min bouts of moderate-intensity walking at between 5.8 and 6.4 km/h every 20 min .


After an initial 2 h period seated , participants consumed a test meal ( 75 g carbohydrate , 50 g fat ) and completed each condition over the next 5 h. Resting blood pressure was assessed oscillometrically every hour as a single measurement , 5 min prior to each activity bout .


GEE models were adjusted for sex , age , BMI , fasting blood pressure and treatment order .


After adjustment for potential confounding variables , breaking up prolonged sitting with light and moderate-intensity activity breaks was associated with lower systolic blood pressure [ light : 120 1 mmHg ( estimated marginal mean SEM ) , P = 0.002 ; moderate : 121 1 mmHg , P = 0.02 ] , compared to uninterrupted sitting ( 123 1 mmHg ) .


Diastolic blood pressure was also significantly lower during both of the activity conditions ( light : 76 1 mmHg , P = 0.006 ; moderate : 77 1 mmHg , P = 0.03 ) compared to uninterrupted sitting ( 79 1 mmHg ) .


No significant between-condition differences were observed in mean arterial pressure or heart rate .


Regularly breaking up prolonged sitting may reduce systolic and diastolic blood pressure .


ACTRN12609000656235 ( http://www.anzctr.org.au ) TRIAL REGISTRATION DATE : August 4th 2009 .


Physical illnesses frequently co-occur with depression and substance use disorders and may impact their improvement .


Physical illness symptoms may overlap with or exacerbate somatic symptoms of depression .


Individuals may use substances to cope with symptoms of physical illness .


We examined whether chronic physical health problems moderated changes in depression and substance use among dual diagnosed individuals during and in the year following treatment .


Participants were recruited from a Veterans Affairs dual diagnosis outpatient program between March 2000 and November 2007 and were randomized to either Integrated Cognitive-Behavioral Therapy or Twelve-Step Facilitation Therapy .


A total of 214 veterans with assessment data for the variables of interest were included in analyses .


Participants completed quarterly depression , substance use , and health assessments over an 18 month period .


We used linear-mixed effects models to analyze patterns of change for depression and substance use .


Individuals with severe chronic health problems and higher intake depression showed slower improvements in both nonsomatic and somatic depression symptoms .


Individuals with severe chronic health problems and higher midtreatment substance use showed less improvement in substance use .


Assessing and addressing physical health issues during depression and substance use disorder treatment may improve outcomes .


Several different surgical techniques have been described to address the coracoclavicular ( CC ) ligaments in acromioclavicular ( AC ) joint injuries .


However , very few techniques focus on reconstructing the AC ligaments , despite its importance in providing stability .


The purpose of our study was to compare the biomechanical properties of two free-tissue graft techniques that reconstruct both the AC and CC ligaments in cadaveric shoulders , one with an extramedullary AC reconstruction and the other with an intramedullary AC reconstruction .


We hypothesized intramedullary AC reconstruction will provide greater anteroposterior translational stability and improved load to failure characteristics than an extramedullary technique .


Six matched cadaveric shoulders underwent translational testing at 10 N and 15 N in the anteroposterior and superoinferior directions , under AC joint compression loads of 10 N , 20 N , and 30 N.


After the AC and CC ligaments were transected , one of the specimens was randomly assigned the intramedullary free-tissue graft reconstruction while its matched pair received the extramedullary graft reconstruction .


Both reconstructed specimens then underwent repeat translational testing , followed by load to failure testing , via superior clavicle distraction , at a rate of 50 mm/min .


Intramedullary reconstruction provided significantly greater translational stability in the anteroposterior direction than the extramedullary technique for four of six loading conditions ( p < 0.05 ) .


There were no significant differences in translational stability in the superoinferior direction for any loading condition .


The intramedullary reconstructed specimens demonstrated improved load to failure characteristics with the intramedullary reconstruction having a lower deformation at yield and a higher ultimate load than the extramedullary reconstruction ( p < 0.05 ) .


Intramedullary reconstruction of the AC joint provides greater stability in the anteroposterior direction and improved load to failure characteristics than an extramedullary technique .


Reconstruction of the injured AC joint with an intramedullary free tissue graft may provide greater strength and stability than other currently used techniques , allowing patients to have improved clinical outcomes .


Pharmacokinetic data regarding a drug-drug interaction between everolimus and tacrolimus are sparse .


In a pharmacokinetic substudy of the randomized ASSET trial , 46 de novo kidney transplant patients receiving very low ( 1.5-3 ng/mL ) or low ( 4-7 ng/mL ) tacrolimus exposure after month 3 , both with everolimus and steroids , provided area under the curve ( AUC ) concentration profiles at day 5 and months 1 , 3 , and 12 .


At month 12 , mean values for tacrolimus trough concentration ( C0 ) , peak concentration ( Cmax ) , and AUC0-12 in the very low tacrolimus group were approximately half that in the low tacrolimus group , but everolimus dose , C0 , Cmax , and AUC0-12 were virtually identical in both groups .


In a cross-study comparison with data at months 1 and 3 from the pharmacokinetic substudy of the A2307 trial , in which patients received cyclosporine , mean values for everolimus C0 , Cmax and AUC0-12 were similar to those in the ASSET trial but the everolimus dose needed to achieve similar exposure was 1.5 - to 2-fold higher with concomitant tacrolimus versus cyclosporine .


Everolimus exposure is unaffected when tacrolimus exposure is down-titrated within the trough concentration range of 1.5-7 ng/mL .


Higher doses of everolimus are needed to achieve a given exposure when combined with tacrolimus versus cyclosporine .


Patient-relevant treatment benefit is traditionally measured with health-related quality of life ( HRQoL ) instruments .


The Patient Benefit Index ( PBI ) methodology allows for a more direct measurement , with the patients rating both importance and achievement of treatment goals .


Here , we developed and validated a PBI version specific for the assessment of benefit in lymphedema and lipedema treatment ( PBI-L ) .


The development included five steps : ( 1 ) open item collection ; ( 2 ) consensus of items in a multidisciplinary expert panel ; ( 3 ) application of the German PBI-L in a cross-sectional study ( n = 301 ) ; ( 4 ) translation into English ; ( 5 ) application of the English PBI-L in a randomized clinical trial ( n = 82 ) .


Subscales were developed using factor analysis .


Construct validity was analyzed by correlating PBI-L and convergent criteria such as HRQoL and quality of care .


To test for responsiveness , the association to change in HRQoL measures was computed .


Floor and ceiling effects were low .


There were few missing values .


Two well-interpretable subscales were found with Cronbach 's alpha > 0.8 each .


Global and subscale scores correlated with convergent criteria and with change in disease-specific HRQoL , but not with change in generic HRQoL .


The PBI-L is an internally consistent , valid , and responsive instrument for the assessment of patient-relevant benefit of edema treatment .


Heart failure ( HF ) is a major public health problem affecting predominantly older adults .


Nonadherence to diet remains a significant contributor to acute decompensated HF ( ADHF ) .


The sodium-restricted Dietary Approaches to Stop Hypertension ( DASH/SRD ) eating plan reduces cardiovascular dysfunction that can lead to ADHF and is consistent with current HF guidelines .


We propose that an intervention that promotes adherence to the DASH/SRD by home-delivering meals will be safe and improve health-related quality of life ( QOL ) in older adults after hospitalization for ADHF .


This is a 3-center , randomized , single-blind , controlled trial of 12-week duration designed to determine the safety and efficacy of home-delivered DASH/SRD-compliant meals in older adults after discharge from ADHF hospitalization .


Sixty-six subjects will be randomized in a 1:1 stratified fashion by gender and left ventricular ejection fraction ( < 50 % vs 50 % ) .


Study subjects will receive either preprepared , home-delivered DASH/SRD-compliant meals or usual dietary advice for 4weeks after hospital discharge .


Investigators will be blinded to group assignment , food diaries , and urinary electrolyte measurements until study completion .


The primary efficacy end point is the change in the Kansas City Cardiomyopathy Questionnaire summary scores for health-related QOL from study enrollment to 4weeks postdischarge .


Safety evaluation will focus on hypotension , renal insufficiency , and hyperkalemia .


Exploratory end points include echocardiography , noninvasive vascular testing , markers of oxidative stress , and salt taste sensitivity .


This randomized controlled trial will test the efficacy , feasibility , and safety of 4weeks of DASH/SRD after ADHF hospitalization .


By testing a novel dietary intervention supported by multiple levels of evidence including preliminary data in outpatients with stable HF , we will address a critical evidence gap in the care of older patients with ADHF .


If effective and safe , this intervention could be scaled to assess effects on readmission and healthcare costs in older adults after ADHF .


It has been observed that a large number of patients with low urinary tract symptoms due to benign prostatic hyperplasia ( LUTS/BPH ) ) has been treated with a combination of tamsulosin ( TAM ) + Serenoa repens ( SR ) ( TAM + SR ) .


The aim of this study was to compare a combination TAM + SR with TAM and SR alone , to see if there was any difference in efficacy and tolerance of each in patients with LUTS/BPH .


In this prospective study patients had to have prostate volume ( PV ) < 50 mL , International Prostate Symptom Score ( IPSS ) of 7-18 , Quality of Life score ( QoLs ) > 3 , a maximal flow rate ( Qmax ) of 5-15 mL/s , with post voiding residual volume ( PVR ) < 150 mL and serum prostatic antigen ( PSA ) < 4 ng/mL .


TAM ( 0.4 mg ) was administered once a day , SR ( 320 mg ) daily or SR ( 320 mg ) + TAM ( 0.4 mg ) daily for a median period of 6 months .


A total of 297 patients were recruited , whereas 265 patients were fully available : 87 into the group TAM , 97 into the group SR and 81 into the group TAM + SR. .


There was no statistically significant difference between the treatment groups in the sense of demographic and other baseline parameters .


No difference was found among the 3 treatment groups , neither in the major endpoint of the study in the sense of a change between baseline and final evaluation in total IPSS , obstructive and irritative subscores , improvement of QoLs , increase in Qmax , nor for the second endpoint including diminution of PV , PSA and PVR .


During the treatment period 20 ( 23 % ) of the patients managed with TAM and 17 ( 21 % ) with TAM + SR had drug - treated with related adverse reactions .


No adverse effect was detected in the group SR. .


Treatment of BPH by both SR and TAM seems to be efficacious alone .


None of them had superiority over another and , additionally , a combined therapy ( TAM + SR ) does not provide extra benefits .


Furthermore , SR is a well-tolerated agent that can be used alternatively in the treatment of LUTS/BPH .


This study investigated the effect of high frequency transcutaneous electric nerve stimulation ( TENS ) as a pain relieving complementary therapy at the transition from epidural ( EDA ) to general analgesia after pancreatic surgery by horizontal , abdominal incision .


Fifty-five consecutive patients undergoing pancreatic resection were enrolled in the study and randomly assigned to active or sham TENS treatment .


Twenty subjects were included in the analysis .


Pain , quality of recovery and additional analgesia consumption were measured during the 24hof transition from EDA to general analgesia .


Additional analgesic consumption and pain estimations at 24hafter EDA termination differed between the two groups , but was not statistically significant .


This study did not find support to reject use of high frequency TENS as complement during transition from EDA to general analgesia after major abdominal surgery with horizontal incision .


To assess the efficacy of Yiqi Zhujing Particle in the treatment of idiopathic oligoasthenozoospermia .


We equally randomized 78 patients with idiopathic oligoasthenozoospermia to a control group and a Yiqi Zhujing group , the former treated with oral medication of zinc gluconate liquid ( 10 ml , bid ) and vitamin E ( 100 mg , bid ) , and the latter given Yiqi Zhujing Granule ( 1 packet , bid ) in addition , both for 3 months .


We compared the semen parameters and biochemical indexes of the seminal plasma obtained before and after medication between the two groups of patients .


After 3 months of treatment , remarkable improvement was observed in the percentage of progressively motile sperm and sperm viability in the control group ( P < 0.05 ) as well as in the total sperm count , sperm concentration , percentage of progressively motile sperm , and sperm viability in the Yiqi Zhujing group ( P < 0.05 ) .


The total sperm count , sperm concentration , percentage of progressively motile sperm , and sperm viability were even more significantly improved in the Yiqi Zhujing than in the control group ( P < 0.05 ) .


Besides , both groups showed different degrees of improvement in the biochemical indexes of the seminal plasma , and the Yiqi Zhujing group exhibited even more significant improvement in seminal plasma zinc , alpha-glucoside enzyme , seminal plasma fructose , and acid phosphatase than the control ( P < 0.05 ) .


The improvement of sperm concentration was correlated positively with the change of seminal plasma zinc ( r = 0.201 , P < 0.05 ) but negatively with that of seminal plasma fructose after treatment ( r = -0.136 , P < 0.05 ) .


There was a positive correlation between the alpha-glucoside enzyme level and sperm viability ( r = 0.314 , P < 0.05 ) .


Yiqi Zhujing Particle is effective for idiopathic oligoasthenozoospermia by significantly improving the total sperm count , sperm concentration , percentage of progressively motile sperm , sperm viability , seminal plasma zinc , seminal plasma fructose , and alpha-glucoside enzyme .


Agents that augment GLP-1 effects enhance glucose-dependent - cell insulin production and secretion and thus are hoped to prevent progressive impairment in insulin secretion characteristic of type 2 diabetes ( T2D ) .


The purpose of this study was to evaluate GLP-1 effects on - cell secretory capacity , an in vivo measure of functional - cell mass , early in the course of T2D .


We conducted a randomized controlled trial in 40 subjects with early T2D who received the GLP-1 analog exenatide ( n = 14 ) , the dipeptidyl peptidase IV inhibitor sitagliptin ( n = 12 ) , or the sulfonylurea glimepiride ( n = 14 ) as an active comparator insulin secretagogue for 6 months .


Acute insulin responses to arginine ( AIRarg ) were measured at baseline and after 6 months of treatment with 5 days of drug washout under fasting , 230 mg/dL ( glucose potentiation of arginine-induced insulin release [ AIRpot ] ) , and 340 mg/dL ( maximum arginine-induced insulin release [ AIRmax ] ) hyperglycemic clamp conditions , in which AIRmax provides the - cell secretory capacity .


The change in AIRpot was significantly greater with glimepiride versus exenatide treatment ( P < 0.05 ) , and a similar trend was notable for the change in AIRmax ( P = 0.1 ) .


Within each group , the primary outcome measure , AIRmax , was unchanged after 6 months of treatment with exenatide or sitagliptin compared with baseline but was increased with glimepiride ( P < 0.05 ) .


- Cell glucagon secretion ( AGRmin ) was also increased with glimepiride treatment ( P < 0.05 ) , and the change in AGRmin trended higher with glimepiride than with exenatide ( P = 0.06 ) .


After 6 months of treatment , exenatide or sitagliptin had no significant effect on functional - cell mass as measured by - cell secretory capacity , whereas glimepiride appeared to enhance - and - cell secretion .


The aim of this study was to assess whether bladder training ( BT ) combined with high-intensity pelvic floor muscle training ( BT+PFMT ) results in better outcomes in the short term than BT alone on female urinary incontinence ( UI ) .


We randomly assigned 108 women with diagnoses of stress UI ( SUI , n = 50 ) , urgency UI ( UUI , n = 16 ) , or mixed UI ( MUI , n = 42 ) to 6 weeks of BT+PFMT or BT alone ( control group ) .


The primary outcome measure was self-reported improvement .


Secondary outcome measures were UI severity , symptom distress , quality of life ( QOL ) , mean number of UI episodes and micturitions per day , and pelvic floor muscle strength and endurance ( PFME ) .


Overall and in the SUI and MUI subgroups , significantly more patients in the BT+PFMT group reported cured and improved symptoms .


Overall and in SUI patients , the BT+PFMT group also improved to significantly greater degree in UI severity , symptom distress , QOL , daily UI episodes , and PFME .


The only parameter showing more improvement in patients with UUI was QOL , and UI severity in patients with MUI ( p < 0.05 ) .


There were no other significant differences between the two study groups in overall and subgroup analysis ( p > 0.05 ) .


High-intensity PFMT combined with BT is more effective than BT alone in the short term for treating UI or SUI .


It appears that the combination therapy may also lead to greater benefits for patients with UUI and MUI .


Based on the results of this study , further studies with larger sample sizes ( for UUI ) and long-term follow-ups are warranted .


To examine the effect of certolizumab pegol ( CZP ) on patient-reported outcomes ( PROs ) in psoriatic arthritis ( PsA ) patients with and without prior tumor necrosis factor ( TNF ) inhibitor exposure .


The ongoing phase III RAPID-PsA trial was double blind and placebo controlled to week 24 .


Patients were randomized 1:1:1 to placebo every 2 weeks or CZP 400 mg at weeks 0 , 2 , and 4 , followed by either CZP 200 mg every 2 weeks or CZP 400 mg every 4 weeks .


PRO measures evaluated were the Health Assessment Questionnaire ( HAQ ) disability index ( DI ) , health status ( measured by the Short Form 36 [ SF-36 ] health survey ) , Psoriatic Arthritis Quality of Life ( PsAQOL ) , Fatigue Assessment Scale , patient assessment of pain ( visual analog scale ) , and Dermatology Life Quality Index ( DLQI ) .


Post hoc analyses of PROs in patients with and without prior TNF inhibitor exposure were conducted .


Change from baseline for all PROs was analyzed for the randomized population using analysis of covariance with last observation carried forward imputation .


A total of 409 patients were randomized .


Twenty percent had received a prior TNF inhibitor .


Baseline demographics were similar between the treatment groups .


At week 24 , clinically meaningful differences in HAQ DI , SF-36 , PsAQOL , fatigue , pain , and DLQI were observed in both CZP arms versus placebo ( P < 0.001 ) , irrespective of prior TNF inhibitor exposure .


More CZP-treated patients reached SF-36 general population norms than placebo-treated patients .


Both CZP dosing schedules provided rapid improvements in PROs across multiple disease aspects in patients with PsA .


The benefits of CZP treatment for health-related quality of life were seen across generic , PsA-specific , and dermatology-specific measures and were observed in patients regardless of prior TNF inhibitor exposure .


The purpose of the study was to evaluate the effect of BodyBalance ( ) training on balance , functional task performance , fear of falling , and health-related quality of life in adults aged over 55 years .


A total of 28 healthy , active adults aged 665 years completed the randomized controlled trial .


Balance , functional task performance , fear of falling , and self-reported quality of life were assessed at baseline and after 12 weeks .


Participants either undertook two sessions of BodyBalance per week for 12 weeks ( n = 15 ) or continued with their normal activities ( n = 13 ) .


Significant group-by-time interactions were found for the timed up and go ( P = 0.038 ) , 30-second chair stand ( P = 0.037 ) , and mediolateral center-of-pressure range in narrow stance with eyes closed ( P = 0.017 ) .


There were no significant effects on fear of falling or self-reported quality of life .


Twelve weeks of BodyBalance training is effective at improving certain balance and functional based tasks in healthy older adults .


Acute inflammation induced by administration of Escherichia coli lipopolysaccharide endotoxin ( LPS ) reduces plasma concentrations of vitamin C and impairs vascular endothelium-derived nitric oxide ( NO ) bioactivity .


We tested the hypothesis that systemically administered high dose vitamin C restores the endogenous anti-oxidant potential and improves NO-dependent vasodilatation in the forearm vasculature .


36 male subjects were enrolled in this balanced , placebo controlled cross-over study .


Forearm blood flow ( FBF ) reactivity to acetylcholine ( ACh ) and glyceryl-trinitrate ( GTN ) , a sensitive test for endothelial function , was assessed at baseline and 4h after LPS-administration ( 20 IU/kg i.v ) .


The effect of two different doses of intravenous vitamin C ( Vitamin C-Injektopas ) , 320 mg/kg and 480 mg/kg over 2h , or placebo on forearm vascular function was studied after LPS .


LPS caused transient flu-like symptoms , decreased plasma vitamin C concentrations and reduced the ACh-dependent increase in FBF by up to 76 % .


Vitamin C at a mean plasma concentration of 3.2 or 4.9 mmol/L restored the response to ACh compared to baseline .


High dose systemic vitamin C recovers LPS-induced endothelium-dependent vasodilation in the forearm resistance vasculature .


This provides a rationale for a further clinical study of the systemic vitamin C effect under inflammatory conditions .


The prevalence of multiple somatic symptoms is high in primary and hospital outpatient populations .


Multiple somatic symptoms may be present in patients sick-listed because of low back pain ( LBP ) and may be associated with increased risk of not returning to work ( RTW ) .


To explore whether multiple somatic symptoms in a subset of patients with nonspecific LBP was associated with RTW , sickness absence ( SA ) , or other social benefits .


The study was a cohort study based on a randomized clinical trial with a prospective 2-year follow-up period .


Patients were referred from general practices to the Spine Center , Regional Hospital Silkeborg , Denmark .


Patients were 285 sick-listed employees ( 4-12 weeks ) , with nonspecific LBP as their prime reason for SA .


Exclusion criteria were unemployment , radiculopathy , LBP surgery within the past year , previous lumbar fusion , suspected cauda equina syndrome , progressive paresis or other serious back disease , pregnancy , known substance abuse , or primary psychiatric diagnosis .


Self-reported health was assessed by the LBP rating scale and questions about pain and health in general .


Disabilities were measured by the Roland Morris Questionnaire , the Short Form-36 , and the Fear-Avoidance Beliefs Questionnaire .


Work-related questions comprised expectations about RTW and risk of losing job because of SA .


The Common Mental Disorder Questionnaire ( subscale SCL-SOM ) was used to assess multiple somatic symptoms ( 12 items ) .


We categorized multiple somatic symptoms into four groups based on the SCL-SOM sum score : < 6 , 6 to 12 , 13 to 18 and > 18 .


Status of SA ( > 2 weeks ) and RTW were gathered from a national database ( DREAM ) .


The patients ( N = 285 ) were randomized into either multidisciplinary or brief intervention at the Spine Center ( 2004-2008 ) .


Both interventions comprised clinical examination and advice by a physiotherapist and a rheumatologist .


Data were collected from questionnaires at baseline ( inclusion ) and 1 year after inclusion .


Data on SA benefits were gathered from the DREAM database that contains data on all social transfer payments ( such as sick leave benefits and other disability benefits ) registered on a weekly basis .


All health factors , female gender , and poor work ability were significantly associated with a higher level of multiple somatic symptoms .


The percentage of persons with SA increased significantly with the symptom score after 1 year , and the duration of SA remained significantly longer after 2 years of follow-up between the multiple somatic symptoms groups .


The percentages with RTW after 1 and 2 years were negatively associated with a higher level of multiple somatic symptoms at baseline .


We found no difference between the intervention groups .


A higher level of multiple somatic symptoms was significantly associated with poor health and work ability at baseline and with longer duration of SA and unsuccessful RTW through a 2-year follow-up period .


Electrical and pharmacological cardioversion ( ECV , PCV ) are important treatment options for symptomatic patients with recent onset atrial fibrillation ( AF ) .


RHYTHM-AF is an international registry of present-day cardioversion providing information that is not currently available on country differences and acute and long-term arrhythmia outcomes of ECV and PCV .


3940 patients were enrolled , of whom 75 % underwent CV .


All patients were followed for 2 months .


There were large variations concerning mode of CV used , ECV being heterogeneous .


A choice of PCV drug depended on the clinical patient profile .


Sinus rhythm was restored in 89.7 % of patients by ECV and in 69.1 % after PCV .


Among patients not undergoing CV during admission , 34 % spontaneously converted to sinus rhythm within 24h .


ECV was most successful in patients pretreated with antiarrhythmic drugs ( mostly amiodarone ) .


PCV was enhanced by class Ic antiarrhythmic drugs ; conversion rate on amiodarone was similar to that seen with rate control drugs .


Female patients and those with paroxysmal and first detected AF as well as those without previous ECV responded well to PCV .


The median duration of hospital stay was 16.2 and 24.0 h for ECV and PCV patients , respectively .


There were very few CV-related complications regardless of mode of CV .


Chronic maintenance of sinus rhythm was enhanced in patients on chronic antiarrhythmic drugs , beta-blockers or inhibitors of the renin-angiotensin system .


Mode of CV varied significantly , but both PCV and ECV were safe and effective .


Class Ic drugs were most effective conversion drugs , but amiodarone is used most frequently despite providing merely rate control rather than shorten time to conversion .


Systemic hypothermia may reduce infarct size if established before reperfusion .


The large surface area of the bowel may facilitate rapid hypothermia .


We therefore examined the feasibility , safety , and efficacy of hypothermia induced by an automated peritoneal lavage system in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention .


Patients with ST-segment-elevation myocardial infarction within 6 hours of symptom onset were randomized to peritoneal hypothermia before and for 3 hours after percutaneous coronary intervention versus control .


The primary safety end point was the 30-day composite rate of death , reinfarction , ischemia-driven target vessel revascularization , major bleeding , sepsis , pneumonia , peritonitis , severe arrhythmia , or renal failure .


The primary efficacy end point was infarct size assessed by cardiac MRI on day 3 to 5 .


Fifty-four patients were randomized at 7 centers to hypothermia ( n = 28 ) versus control ( n = 26 ) .


Hypothermia was successfully initiated in 96.3 % of patients , and median [ interquartile range ] temperature at first balloon inflation was 34.7 [ 34.0-34 .9 ] C. Median door-to-balloon times in the hypothermia and control groups were 62 [ 51-81 ] and 47 [ 37-55 ] minutes , respectively ( P = 0.007 ) .


The primary safety end point occurred in 6 ( 21.4 % ) and 0 ( 0 % ) patients in the hypothermia and control groups , respectively ( P = 0.01 ) , including 3 versus 0 stent thrombosis events .


Infarct size was 17.2 % [ 15.1-20 .6 ] and 16.1 % [ 10.0-22 .2 ] in the hypothermia and control groups , respectively ( P = 0.54 ) .


Peritoneal hypothermia is feasible and achieves rapid cooling with only a modest increase in treatment times in the setting of ST-segment-elevation myocardial infarction .


However , in the present randomized trial , peritoneal hypothermia was associated with an increased rate of adverse events without reducing infarct size .


http://www.clinicaltrials.gov .


Unique identifier : NCT01655433 .


To determine whether concurrent chemoradiotherapy ( CCRT ) can improve survival rates compared to the neoadjuvant chemotherapy ( NACT ) regimen in locoregionally advanced nasopharyngeal carcinoma ( NPC ) patients .


A total of 338 patients with biopsy-proven NPC were randomly assigned to receive NACT followed by radical radiotherapy ( RT ) then adjuvant chemotherapy ( AC ) or CCRT followed by AC .


With a median follow-up of 60 months , the 5-year overall survival ( OS ) rate did not differ significantly between two groups ( 75.5 % vs 79.4 % in CCRT and NACT group respectively , P = 0.47 , HR = 0.84 , 95 % CI 0.53-1 .33 ) .


Metastasis-free survival ( MFS ) rate was significantly improved by the CCRT ( 79.0 % vs 86.9 % , P = 0.05 , HR = 0.59 , 95 % CI 0.35-1 .00 ) .


Subgroup analysis indicated that the benefit of CCRT was derived from N0/N1 tumors ( 78.0 % vs 93.5 % , P = 0.05 , HR = 0.35 , 95 % CI 0.12-0 .99 ) .


Higher rates of mucositis ( 52.4 % vs. 35.9 % P = 0.02 ) and vomiting ( 13.7 % vs. 4.7 % P = 0.00 ) were noted in the CCRT arm .


Late toxicities were similar in two groups .


The updated results demonstrated no significant survival benefit of CCRT over NACT in patients with locoregionally advanced NPC .


CCRT only showed significant MFS efficacy in T3-4N0-1 populations .


Lumbar transforaminal epidural injections are commonly utilized to treat radicular pain due to intervertebral disc herniation .


This study aims to determine if there was a major difference in effectiveness between particulate and nonparticulate corticosteroids for acute radicular pain due to lumbar disc herniation .


A multicenter , double blind , prospective , randomized trial on 78 consecutive subjects with acute uni-level disc herniation resulting in unilateral radicular pain .


All subjects received a single level transforaminal epidural steroid injection with either dexamethasone or triamcinolone .


Repeat injections were allowed as determined by the blinded physician and subjects .


Primary outcomes included : number of injections received , surgical rates , and categorical pain scores at 2 weeks , 3 months , and 6 months .


Secondary outcomes included mean Oswestry Disability Index .


Both triamcinolone and dexamethasone resulted in statically significant improvements in pain and function at 2 weeks , 3 months , and 6 months , without clear differences between groups .


The surgical rates were comparable with 14.6 % of the dexamethasone group and 18.9 % of the triamcinolone group receiving surgery .


There was a statistically significant difference in the number of injections received , with 17.1 % of the dexamethasone group receiving three injections vs only 2.7 % of the triamcinolone group .


Transforaminal epidural corticosteroid injections are an effective treatment for acute radicular pain due to disc herniation , and frequently only require 1 or 2 injections for symptomatic relief .


Dexamethasone appears to possess reasonably similar effectiveness when compared with triamcinolone .


However , the dexamethasone group received slightly more injections than the triamcinolone group to achieve the same outcomes .


To test the feasibility and effectiveness of a Web-based lifestyle intervention based on the Diabetes Prevention Program modified for women with recent gestational diabetes mellitus to reduce postpartum weight retention .


We randomly allocated 75 women with recent gestational diabetes mellitus to either a Web-based lifestyle program ( Balance after Baby ) delivered over the first postpartum year or to a control group .


Primary outcomes were change in body weight at 12 months from 1 ) first postpartum measured weight ; and 2 ) self-reported prepregnancy weight .


There were no significant differences in baseline characteristics between groups including age , body mass index , race , and income status .


Women assigned to the Balance after Baby program ( n = 36 , three lost to follow-up ) lost a mean of 2.8 kg ( 95 % confidence interval -4.8 to -0.7 ) from 6 weeks to 12 months postpartum , whereas the control group ( n = 39 , one lost to follow-up ) gained a mean of 0.5 kg ( -1.4 to +2.4 ) ( P = .022 ) .


Women in the intervention were closer to prepregnancy weight at 12 months postpartum ( mean change -0.7 kg ; -3.5 to +2.2 ) compared with women in the control arm ( +4.0 kg ; +1.3 to +6.8 ) ( P = .035 ) .


A Web-based lifestyle modification program for women with recent gestational diabetes mellitus decreased postpartum weight retention .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT01158131 .


I.


To observe differences of therapeutic effects among acupuncture bloodletting , penicillin and acupuncture bloodletting combined with penicillin for children acute tonsillitis and providea better treatment method in cli nic .


Seventy-five mild cases were selected into section of mild symptoms while seventy-five severe cases were selected into section of severe symptoms .


Cases in the two sections then were divided into , an acupuncture bloodletting group , a penicillin group and a comprehensive group by random digital table method separately , 25 cases in each one .


Qu-chi ( LI 11 ) , Hegu ( LI 4 ) , Dazhui ( GV 14 ) , Shaoshang ( LU 11 ) and Erjian ( EX 11 ) were selected in the acupuncture bloodletting group , intravenous injection of penicillin sodium was applied in the penicillin group and acupuncture bloodletting combined with penicillin was applied in the comprehensive group .


Efficacy assessment was conducted after 3 days in the section of mild symptoms and after 5 days in the section of severe symptoms .


For the section of mild symptoms , the total effective rate was 96.0 % ( 24/25 ) in the comprehensive group and 92.0 % ( 23/25 ) in the acupuncture bloodletting group , which were both superior to 68.0 % ( 17/25 ) in the penicillin group ( P < 0.05 ) , but no statistical significance was seen between the comprehensive group and acupuncture bloodletting group ( P > 0.05 ) .


For the section of severe symptoms , the total effective rate was 96.0 % ( 24/25 ) in the comprehensive group , which was obviously superior to 60.0 % ( 15/25 ) in the acupuncture bloodletting group ( P < 0.01 ) and 68.0 % ( 17/25 ) in the penicillin group ( P < 0.05 ) , and no statistical significance was seen between the acupuncture bloodletting group and penicillin group ( P > 0.05 ) .


The efficacy of acupuncture bloodletting combined with penicillin is little different from that of acupuncture bloodletting for treatment of children acute tonsillitis with mild accompanied symptoms , which were both superior to intravenous injection of penicillin sodium .


For severe accompanied symptoms , the efficacy of acupuncture bloodletting combined with penicillin is obviously superior to acupuncture bloodletting and penicillin .


To evaluate the effects of sex and menopausal status on acute - , continuation - , and maintenance-phase treatment outcomes in patients with recurrent major depressive disorder ( MDD ) .


This was a secondary analysis of data from the Prevention of Recurrent Episodes of Depression With Venlafaxine for Two Years ( PREVENT ) trial , a multiphase , multicenter , double-blind study in which adult outpatients with recurrent MDD ( by DSM-IV criteria ) were randomly assigned to 10 weeks of acute-phase venlafaxine extended release ( ER ) ( 75-300 mg/d ) or fluoxetine ( 20-60 mg/d ) .


Patients achieving response or remission had 6 months of continuation-phase treatment .


Responding or remitting patients in the venlafaxine ER group were randomly assigned to venlafaxine ER or placebo for 2 consecutive 12-month maintenance phases ; fluoxetine-treated patients continued receiving fluoxetine .


The outcome measures for this analysis were acute - and continuation-phase response and remission rates ( as measured by the 17-item Hamilton Depression Rating Scale ) and time to depression recurrence in the maintenance phases according to sex and menopausal status at baseline .


The intent-to-treat population comprised 781 patients in the venlafaxine ER group ( 65 % women ) and 266 patients in the fluoxetine group ( 61 % women ) ; 64 % of all women were premenopausal , and 25 % were postmenopausal ( 5 % perimenopausal ; not analyzed ) .


At acute-phase end , remission rates in the venlafaxine ER vs fluoxetine groups were 44 % vs 47 % in men , 51 % vs 52 % in women , 50 % vs 52 % in premenopausal women , and 52 % vs 55 % in postmenopausal women .


At continuation-phase end , remission rates in the venlafaxine ER vs fluoxetine groups were 71 % vs 74 % in men , 72 % vs 67 % in women , 72 % vs 69 % in premenopausal women and 71 % vs 63 % in postmenopausal women .


Response rates were consistent with these findings .


Based on a Cox proportional hazards model , sex was not a significant predictor of recurrence during the first or second maintenance phase ( hazard ratio [ HR ] = 1.233 ; P = .3712 and HR = 1.103 ; P = .8075 , respectively ) , and neither was menopausal status at acute-phase baseline ( HR = 0.941 ; P = .8234 and HR = 0.531 ; P = .2065 , respectively ) .


In this study of patients with recurrent MDD , treatment outcomes with venlafaxine ER and fluoxetine did not differ on the basis of sex or menopausal status .


Our confidence in these findings is limited by the lack of a placebo arm during the acute and continuation phases and by the small sample sizes for subgroup analyses in the maintenance phases .


ClinicalTrials.gov identifier : NCT00046020 .


To assess the design and the Mainland China subgroup baseline characteristics of the study to evaluate the efficacy and safety of alogliptin versus placebo in subjects with type 2 diabetes ( T2DM ) as monotherapy , add-on to metformin or add-on to pioglitazone .


This was a multi-center , randomized , double-blind , placebo-controlled , 16-week study comparing alogliptin ( ALO , 25 mg , 1/d ) versus placebo ( PLA ) as monotherapy ( A ) , add-on to metformin ( B ) or add-on to pioglitazone metformin ( C ) .


The T2DM subjects with glycosylated hemoglobin A1c ( HbA1c ) between 7 % and 10 % and aged between 18 years and 75 years were enrolled and randomized to the alogliptin group and the placebo group in 1 : 1 ratio with 16 weeks treatment .


All patients were followed up every 4 weeks .


The safety endpoints consisted of the incidence of hypoglycemia and other adverse events .


A total of 491 patients were enrolled in the Mainland China subgroup of the study ( 181 in group A , 186 in group B and 124 in group C ) .


In each treatment group , the baseline characteristics including age , gender , body mass index , diabetes duration , HbA1c , fasting plasma glucose , body weight , daily dosage of metformin and daily dosage of pioglitazone were all well balanced .


The demographic data , medical history , glycemic profile and treatment regimen at baseline in Mainland China subgroup are well balanced .


The result of this study will provide the clinical evidence for the use of alogliptin in Chinese T2DM patients .


Behavioral activation ( BA ) is an empirically validated treatment that reduces depression by increasing overt behaviors and exposure to reinforcing environmental contingencies .


Although research has identified an inverse correlation between pleasant or rewarding activities and depression , the causal relation between increased structured activities and reduced depression has not directly been studied .


In the context of a recent randomized trial ( Hopko , Armento , et al. , 2011 ) , this study used longitudinal data and growth curve modeling to examine relationships among the quantity of activities completed , proportion of activities completed ( i.e. , therapeutic compliance ) , environmental reward , and depression in breast cancer patients treated with BA treatment for depression ( n = 23 ) .


Therapeutic compliance with assigned activities was causally related to depression reduction , whereas the specific quantity of completed activities was not systematically related .


Logistic regression indicated that for patients completing all assigned activities , treatment response and remission were achieved for all patients .


Neither therapeutic compliance nor the quantity of completed activities was directly associated with self-reported environmental reward during the BA interval ( Session 3 to posttreatment ) , and environmental reward did not mediate the relation between activation and depression .


Patient compliance with BA assignments is causally associated with depression reduction , whereas the quantity of completed activities is less relevant toward conceptualizing positive treatment outcome .


Study findings are discussed in the context of behavioral models of depression and BA therapy .


Our previous study , a 6-month randomised controlled trial , demonstrated that a group-based support promoted weight loss as compared to an education-only intervention .


The purpose of this study was to examine weight loss maintenance for 2 years .


Originally , 188 overweight Japanese adults , aged 40-65 years , were randomly assigned to 3 groups : control , education-only or group-based support .


After the 6-month intervention , 125 participants in the education-only and the group-based support groups were followed up for 2 years .


The primary outcome was the amount of weight lost .


The participants were retrospectively grouped into quartiles of percent weight loss for secondary analyses .


At the end of follow-up , the amount of weight lost in the education-only and the group-based support groups was the same ( 3.3 kg ) .


Secondary analyses using data of those who completed the study ( n = 100 ) revealed that the participants in the highest quartile of percent weight loss significantly increased their step counts and moderate-to-vigorous physical activity compared with the lowest quartile .


No significant differences were observed in the energy intake among the four groups .


The effects of group-based support disappear within 2 years .


Increasing physical activity may be a crucial factor for successful maintenance of weight loss .


To date only a few randomized controlled studies have compared grafting strategies in patients with multi-vessel coronary disease .


This study represents a pilot RCT designed to test the feasibility of a trial comparing conventional CABG performed with a LIMA-LAD plus saphenous vein grafts ( LIMA+SVG ) and CABG performed with total arterial grafting ( TAG ) .


Consenting patients undergoing non-redo isolated CABG surgery at a single institution were randomized to TAG or LIMA+SVG groups .


Exclusion criteria included prior CABG , emergent procedure , concomitant procedure , varicose veins and renal dysfunction .


The primary endpoints were : enrolment > 20 % and completion of CT coronary angiography at 6 months > 80 % .


Statistical investigation was performed on an intention to treat analysis .


Of 421 eligible patients , 60 were enrolled and 2 withdrew ( n = 30 in TAG , n = 28 LIMA+SVG ) for 14 % enrolment rate .


Patient characteristics were similar in each group .


No patients died in hospital and adverse events such as MI , stroke and deep sternal wound infection were not significantly different between groups .


Clinical follow-up was complete in 100 % of patients , with 44/58 ( 76 % ) undergoing CT coronary angio at 6 months .


Graft occlusion occurred in 2 patients in each group for patency rates of 89 % ( TAG ) and 91 % ( LIMA+SVG ) .


We provide evidence that an RCT comparing grafting strategy is possible but also show that achieving recruitment or follow-up CT may be difficult .


Given the excellent patency results and little difference between groups , our findings suggest that the sample size required may make it infeasible to compare graft patency at 6 months as a study end-point .


Randomized Controlled Trial number : ISRCTN80270323 .


Few RCT 's exist comparing conventional CABG performed with a LIMA-LAD plus saphenous vein grafts ( LIMA+SVG ) compared to CABG performed with total arterial grafting ( TAG ) .


This study is a pilot RCT designed to test the feasibility of such a trial and identify pitfalls .


We measured the long-term retention of knowledge gained through selected American Academy of Neurology annual meeting courses and compared the effects of repeated quizzing ( known as test-enhanced learning ) and repeated studying on that retention .


Participants were recruited from 4 annual meeting courses .


All participants took a pretest .


This randomized , controlled trial utilized a within-subjects design in which each participant experienced 3 different postcourse activities with each activity performed on different material .


Each key information point from the course was randomized in a counterbalanced fashion among participants to one of the 3 activities : repeated short-answer quizzing , repeated studying , and no further exposure to the materials .


A final test covering all information points from the course was taken 5.5 months after the course .


Thirty-five participants across the 4 courses completed the study .


Average score on the pretest was 36 % .


Performance on the final test showed that repeated quizzing led to significantly greater long-term retention relative to both repeated studying ( 55 % vs 46 % ; t [ 34 ] = 3.28 , SEM = 0.03 , p = 0.01 , d = 0.49 ) and no further exposure ( 55 % vs 44 % ; t [ 34 ] = 3.16 , SEM = 0.03 , p = 0.01 , d = 0.58 ) .


Relative to the pretest baseline , repeated quizzing helped participants to retain almost twice as much of the knowledge acquired from the course compared to repeated studying or no further exposure .


Whereas annual meeting continuing medical education ( CME ) courses lead to long-term gains in knowledge , when repeated quizzing is added , retention is significantly increased .


CME planners may consider adding repeated quizzing to increase the impact of their courses .


Methylene blue ( MB ) has been shown to be safe and effective against falciparum malaria in Africa and to have pronounced gametocytocidal properties .


Three days of treatment with artesunate ( AS ) - amodiaquine ( AQ ) combined with MB was compared with AS-AQ treatment in a randomized controlled phase IIb study ; the study included 221 children aged 6-59 months with uncomplicated falciparum malaria in Burkina Faso .


The primary end point was gametocyte prevalence during follow-up , as determined by microscopy and real-time quantitative nucleic acid sequence-based amplification ( QT-NASBA ) .


The gametocyte prevalence of Plasmodium falciparum at baseline was 3.6 % ( microscopy ) and 97 % ( QT-NASBA ) .


It was significantly lower in the AS-AQ-MB than in the AS-AQ group on day 7 of follow-up ( microscopy , 1.2 % vs 8.9 % [ P < .05 ] ; QT-NASBA , 36.7 % vs 63.3 % [ P < .001 ] ) .


Hemoglobin values were significantly lower in the AS-AQ-MB group than in the AS-AQ group at days 2 and 7 of follow-up .


Vomiting of the study medication occurred significantly more frequently in the AS-AQ-MB group .


The combination of MB with an artemisinin-based combination therapy has been confirmed to be effective against the gametocytes of P. falciparum .


MB-based combinations need to be compared with primaquine-based combinations , preferably using MB in an improved pediatric formulation .


Clinical Trials Registration : NCT01407887 .


To prospectively assess treatment response using volumetric functional magnetic resonance imaging ( MRI ) metrics in patients with hepatocellular carcinoma ( HCC ) treated with the combination of doxorubicin-eluting bead-transarterial chemoembolization ( DEB TACE ) and sorafenib .


A single center study enrolled 41 patients treated with systemic sorafenib , 400 mg twice a day , combined with DEB TACE .


All patients had a pre-treatment and 3-4 week post-treatment MRI .


Anatomic response criteria ( RECIST , mRECIST and EASL ) and volumetric functional response ( ADC , enhancement ) were assessed .


Statistical analyses included paired Student 's t-test , Kaplan-Meier curves , Cohen 's Kappa , and multivariate cox proportional hazard model .


Median tumour size by RECIST remained unchanged post-treatment ( 8.34.1 cm vs. 8.14.3 cm , p = 0.44 ) .


There was no significant survival difference for early response by RECIST ( p = 0.93 ) .


EASL and mRECIST could not be analyzed in 12 patients .


Volumetric ADC increased significantly ( 1.3210 ( -3 ) mm ( 2 ) / sec to 1.6010 ( -3 ) mm ( 2 ) / sec , p < 0.001 ) , and volumetric enhancement decreased significantly in HAP ( 38.2 % to 17.6 % , p < 0.001 ) and PVP ( 76.6 % to 41.2 % , p < 0.005 ) .


Patients who demonstrated 65 % decrease PVP enhancement had significantly improved overall survival compared to non-responders ( p < 0.005 ) .


Volumetric PVP enhancement was demonstrated to be significantly correlated with survival in the combination of DEB TACE and sorafenib for patients with HCC , enabling precise stratification of responders and non-responders .


PVP enhancement is significantly correlated with survival in responders ( p < 0.005 ) .


There was no significant survival difference for early response using RECIST ( p = 0.93 ) .


mRECIST or EASL could not assess tumour response in 29 % of patients .


To determine whether insulin delivered via a 4-mm 32-gauge pen needle ( PN ) provides equivalent glycemic control as 8-mm 31-gauge and 12.7-mm 29-gauge PNs in obese ( body mass index 30 ) patients with diabetes .


This prospective , multicenter , randomized , open-label , 2-period , crossover , equivalence , home-based study was conducted from October 26 , 2010 , through May 31 , 2012 .


After a 3-week wash-in period , eligible patients aged 18 to 80 years with a hemoglobin A1c ( HbA1c ) level of 5.5 % to 9.5 % ( 37-80 mmol/mol ) were randomized to compare either 4 - vs 8-mm PNs or 4 - vs 12.7-mm PNs , using each of the 2 assigned PNs for 12 weeks in random order .


The primary outcome was change in HbA1c level , with equivalence limits of 0.4 % .


The 274 patients randomized ( mean SD age , 56.711.0 years ) had a mean SD body mass index of 37.06.1 ( range , 29.1-59 .9 ) and took up to 350 U of insulin daily ; 226 patients were included in the modified intention-to-treat analysis .


Mean ( 95 % CI ) changes in HbA1c levels with the 4-mm PN were -0.08 % ( -0.21 to 0.06 ) and -0.10 % ( -0.19 to 0.00 ) vs the 8 - and 12.7-mm PNs , respectively , within equivalence margins .


The 4-mm PN was less painful than the larger PNs ( P < .05 ) , with similar leakage rates reported ( 4.1 % -4.3 % ) .


Patients preferred the 4-mm PN over the 12.7-mm PN ( P < .05 ) but not significantly vs the 8-mm PN .


There were no differences between PNs in insulin doses and hypoglycemic or hyperglycemic adverse event rates .


The 4-mm 32-gauge PN provides equivalent glycemic control as 8 - and 12.7-mm PNs in obese patients with diabetes , with less pain and no increase in leakage .


Shorter PNs should be considered in all insulin-requiring patients with diabetes , including those who are obese .


clinicaltrials.gov Identifier : NCT01231984 .


External ventricular drainage ( EVD ) and lumbar drainage ( LD ) are the most widely used procedures for continued bloody cerebrospinal fluid drainage .


Each has his own advantages and disadvantages .


Here , we compared complications and clinical outcomes in patients with World Federation of Neurosurgical Societies ( WFNS ) grade III aneurysmal subarachnoid hemorrhage ( aSAH ) who underwent coil placement followed by EVD or LD .


In this prospective , controlled study , all patients with aSAH classified as WFNS grade III who underwent coil placement at our institution were divided randomly into 2 groups : the EVD group and the LD group .


The ratios of intracerebral hemorrhage , vasospasm , infection , duration of catheter placement , hydrocephalus , and Glasgow outcome scale ( GOS ) after 2 months of onset were analyzed between the 2 groups .


A total of 148 patients ( mean age 56.8 years ) were enrolled in this study .


Seventy-six patients were assigned to the EVD group , and 72 patients were assigned to the LD group .


The average time interval from stroke onset to surgery was 35.1 h. Compared with the EVD group , the LD group had a lower incidence of intracerebral hemorrhage , slightly higher rates of infection and hydrocephalus , and similar vasospasm and chronic hydrocephalus rates , durations of catheter placement , and GOS scores at 2 months after onset .


In order to improve the clinical outcomes of patients with aSAH , we suggest that LD is better than EVD for patients with WFNS grade III aSAH who underwent coil placement .


To investigate the effect of antibiotics on postoperative inflammatory complications after surgical extraction of the impacted mandibular third molar .


Ninety-Six patients had their bilateral third molars removed through a split-mouth , double-blind , controlled , clinical trial in two visits .


On one side amoxicillin ( or clindamycin ) was used ( antibiotics group ) from 1 h pre-operation to 3 d post-operation .


On the other side , placebo was used ( placebo group ) the same time .


Postoperative inflammatory complications including alveolar osteitis ( AO ) , surgical site infection ( SSI ) , pre-buccal site infection and anterior isthmus faucium space infection were monitored and recorded 2 d and 10 d after the surgery .


The pain , swelling , and trismus were also recorded .


All 96 patients completed the study .


Two AO ( 2.1 % ) , one SSI ( 1.0 % ) and seven other infections were observed in the treatment group .


Also three AO ( 3.1 % ) , one SSI ( 1.0 % ) and eleven other infections were observed in the placebo group .


However , no statistically significant differences were found in the incidence of various postoperative inflammatory complications and reactions between the groups ( P > 0.05 ) .


There was no significant difference on the postoperative reaction , except pain on 10 d. Patients who had inflammatory infection recovered well with symptomatic anti-infection treatment .


The use of amoxicillin ( or clindamycin ) can not effectively prevent and reduce the postoperative inflammatory complications after surgical extraction of the impacted mandibular third molar .


The identification of the cause of chronic low back pain ( CLBP ) represents a great challenge to orthopedists due to the controversy over the diagnosis of discogenic low back pain ( DLBP ) and the existence of a number of cases of CLBP of unknown origin .


This study aimed to develop diagnostic models to distinguish DLBP from other forms of CLBP and to identify serum biomarkers for DLBP .


Serum samples were collected from patients with DLBP , chronic lumbar disc herniation ( LDH ) , or CLBP of unknown origin , and healthy controls ( N ) , and randomly divided into a training set ( n = 30 ) and a blind test set ( n = 30 ) .


Matrix-assisted laser desorption ionization time-of-flight mass spectrometry was performed for protein profiling of these samples .


After the discriminative ability of two most significantly differential peaks from each two groups was assessed using scatter plots , classification models were developed using differential peptide peaks to evaluate their diagnostic accuracy .


The identity of peptides corresponding to three representative differential peaks was analyzed .


The fewest statistically significant differential peaks were identified between DLBP and CLBP ( 3 ) , followed by CLBP vs. N ( 5 ) , DLBP vs. N ( 9 ) , LDH vs. CLBP ( 20 ) , DLBP vs. LDH ( 23 ) , and LDH vs. N ( 43 ) .


The discriminative ability of two most significantly differential peaks was poor in classifying DLBP vs. CLBP but good in classifying DLBP vs. LDH .


The accuracy of models for classification of DLBP vs. CLBP was not very high in the blind test ( forecasting ability , 67.24 % ; sensitivity , 70 % ) , although a higher accuracy was observed for classification of DLBP vs. LDH and LDH vs. N ( forecasting abilities , ~ 90 % ; sensitivities , > 90 % ) .


A further investigation of three representative differential peaks led to the identification of two peaks as peptides of complement C3 , and one peak as a human fibrinogen peptide .


Our findings benefit not only the diagnosis of CLBP but also the understanding of the differences between different forms of DLBP .


The ability to distinguish between different causes of CLBP and the identification of serum biomarkers may be of great value to diagnose different causes of DLBP and predict treatment efficacy .


The aim of this study was to evaluate the cost-effectiveness of a home-based palliative care model relative to usual care in expediting discharge or enabling patients to remain at home .


Economic evaluation of a pilot randomised controlled trial with 28 days follow-up .


Mean costs and effectiveness were calculated for the Palliative Care Extended Packages at Home ( PEACH ) and usual care arms including : days at home ; place of death ; PEACH intervention costs ; specialist palliative care service use ; acute hospital and palliative care unit inpatient stays ; and outpatient visits .


PEACH mean intervention costs per patient ( $ 3489 ) were largely offset by lower mean inpatient care costs ( $ 2450 ) and in this arm , participants were at home for one additional day on average .


Consequently , PEACH is cost-effective relative to usual care when the threshold value for one extra day at home exceeds $ 1068 , or $ 2547 if only within-study days of hospital admission are costed .


All estimates are high uncertainty .


The results of this small pilot study point to the potential of PEACH as a cost-effective end-of-life care model relative to usual care .


Findings support the feasibility of conducting a definitive , fully powered study with longer follow-up and comprehensive economic evaluation .


Figitumumab is a human IgG2 monoclonal antibody targeting insulin-like growth factor 1 receptor ( IGF-1R ) , with antitumor activity in prostate cancer .


This phase II trial randomized chemotherapy-nave men with progressing castration-resistant prostate cancer to receive figitumumab every 3 weeks with docetaxel/prednisone ( Arm A ) or docetaxel/prednisone alone ( Arm B1 ) .


At progression on Arm B1 , patients could cross over to the combination ( Arm B2 ) .


Prostate-specific antigen ( PSA ) response was the primary endpoint ; response assessment on the two arms was noncomparative and tested separately ; H0 = 0.45 versus HA = 0.60 ( = 0.05 ; = 0.09 ) for Arm A ; H0 = 0.05 versus HA = 0.20 ( = 0.05 , = 0.10 ) for Arm B2 .


A comparison of progression-free survival ( PFS ) on Arms A and B1 was planned .


A total of 204 patients were randomized and 199 treated ( Arm A : 97 ; Arm B1 : 102 ) ; 37 patients crossed over to Arm B2 ( median number of cycles started : Arm A = 8 ; B1 = 8 ; B2 = 4 ) .


PSA responses occurred in 52 % and 60 % of Arms A and B1 , respectively ; the primary PSA response objective in Arm A was not met .


Median PFS was 4.9 and 7.9 months , respectively ( HR = 1.44 ; 95 % confidence interval , 1.06-1 .96 ) .


PSA response rate was 28 % in Arm B2 .


The figitumumab combination appeared more toxic , with more treatment-related grade 3/4 adverse events ( 75 % vs. 56 % ) , particularly hyperglycemia , diarrhea , and asthenia , as well as treatment-related serious adverse events ( 41 % vs. 15 % ) , and all-causality grade 5 adverse events ( 18 % vs. 8 % ) .


IGF-1R targeting may merit further evaluation in this disease in selected populations , but combination with docetaxel is not recommended .