The aim of this study was to therefore assess the efficacy of the hybrid therapy as a first-line treatment for H.pylori eradication in a prospective trial .


From December 2012 to August 2013 , 184 patients with confirmed H.pylori infections received either the 14-day hybrid therapy or the 14-day sequential therapy .


Eradication outcomes were evaluated using a 13C-urea breath test at least 4 weeks after treatment cessation .


A total of 184 patients ( 90 receiving hybrid treatment and 94 receiving sequential treatment ) completed the study .


The eradication rates of the hybrid and sequential therapy groups were 81.1 % ( 73/90 ; 95 % confidence interval [ CI ] = 73.0-89 .2 % ) and 79.8 % ( 75/94 ; 95 % CI = 71.7-87 .9 % ) , respectively , by intention-to-treat analysis ( P = 0.821 ) .


By per protocol analysis , eradication rates were 85.9 % ( 73/85 ; 95 % CI = 78.5-93 .3 % ) and 82.0 % ( 73/89 ; 95 % CI = 74.0-89 .9 % ; P = 0.489 ) , respectively .


There were no significant intergroup differences in treatment compliance or discontinuation induced by severe side effects .


The hybrid therapy achieved acceptable eradication rate ( 85.9 % ) , but not statistically significantly higher rates than the sequential therapy ( 82.0 % ) .


Further studies are therefore needed to identify first-line treatments with even better eradication rates in the Korean population .


The purpose of this study was to quantify the time required for transvaginal cervical length measurements during a second-trimester anatomy scan and to evaluate patient attitudes regarding cervical length assessment .


Consenting women were randomly assigned to one of the following : ( 1 ) standard arm-cervix visualized , no prespecified cervical length measurement ; ( 2 ) sequential arm-3 transabdominal cervical length measurements obtained , transvaginal sonography performed if images were inadequate or if any measurement was 3 cm or less ; and ( 3 ) screening transvaginal sonography arm-3 transvaginal cervical length measurements obtained .


Times were recorded for the entire examination and cervical length evaluation .


Participants completed a questionnaire at the end of their visits .


Sixty of 230 eligible women enrolled .


Demographic characteristics were similar across groups except for body mass index , which was greater in the sequential arm than the screening arm ( mean SD , 28.5 7.75 versus 24.7 3.89 kg/m ( 2 ) ; P = .03 ) .


There were no differences in total examination times between the 3 arms ( 24.8 8.59 versus 27.8 8.75 versus 28.5 7.78 minutes ; P = .39 ) .


There were no differences across groups in participant attitudes regarding examination discomfort or embarrassment .


Performing screening transvaginal sonography to measure cervical length did not have a statistically significant impact on the amount of time for completion of the entire examination .


Participants had positive responses regarding cervical length assessment by transabdominal and transvaginal sonography .


The objective of the study was to evaluate the efficacy of intravaginal application of 5 % 5-fluorouracil ( 5-FU ) for the treatment of cervical intraepithelial neoplasia ( CIN ) 2 in women .


Women aged 18-29 years with CIN 2 were recruited for this randomized controlled trial of observation vs treatment with intravaginal 5-FU .


Women in the observation group returned in 6 months for a Papanicolaou smear , colposcopy , and a human papillomavirus ( HPV ) deoxyribonucleic acid test .


Women in the 5-FU group were treated with intravaginal 5-FU once every 2 weeks for a total of 16 weeks and were similarly evaluated at 6 months .


All women who had a baseline visit were included in the intention-to-treat analysis .


Values of P < .05 were considered statistically significant .


Between August 2010 and June 2013 , 60 women were randomized and had a baseline visit for intervention ( n = 31 ) vs observation ( n = 29 ) .


Of women who had cervical biopsy results at 6 months , regression of disease was demonstrated in 93 % of women in the 5-FU group ( 26 of 28 ) and 56 % of women in the observation group ( 15 of 27 ) .


Under the intention-to-treat analysis , a relative risk for cervical disease regression of 1.62 ( 95 % confidence interval [ CI ] , 1.10-2 .56 ) was found between the 5-FU and observation arms ( P = .01 ) .


When the cervical biopsy , Papanicolaou smear , and HPV results were combined for the 6 month follow-up visit , 50 % of the 5-FU group ( 14 of 28 ) had a documented normal biopsy , normal Papanicolaou smear , and negative HPV test compared with 22 % in the observation group ( 6 of 27 ) ( relative risk , 2.25 ; 95 % confidence interval , 1.05-5 .09 ; P < .05 ) .


There were no moderate or severe side effects in the intervention group .


Topical 5-FU appears to be an effective medical therapy for CIN 2 in young women .


5-FU is readily available and may be considered as an off-label treatment option for young women with CIN 2 who are interested in the treatment of disease but want to avoid excisional procedures .


Pain is expected during noninvasive skin tightening and can be anxiety provoking , especially for those who have not had prior treatments .


To compare pain reported by patients nave to nonablative skin tightening energy devices with those who were not naive .


The non-nave group at least three nonablative laser procedures or one nonablative skin tightening procedure , and the nave group no previous treatments .


Four sites at each of two anatomic locations ( periorbital and midface or cheek ) were treated in each subject with needle prick , pulsed dye laser , radiofrequency , and ultrasound with the order of the interventions randomized .


All interventions except ultrasound were also applied to three abdominal sites .


The difference in mean pain scores between nave and nonnave subjects were averaged over the anatomic sites .


Ten nave and 10 non-nave subjects completed study procedures .


Mean pain scores ranged from 1.3 to 4.9 .


The mean for all nave conditions was 2.3 1.0 , vs 2.2 1.4 for non-nave conditions .


There was no overall difference according to group , device , or anatomic area .


There was no significant difference in pain between nave and non-nave subjects undergoing cutaneous energy treatments .


Individual devices may elicit more pain at specific anatomic locations .


The purpose of this study was to investigate the effects of 4 weeks of custom foot orthotics on pain , disability , recurrence of spinal fixation , and muscle dysfunction in adult low back pain patients receiving limited chiropractic care .


Adult volunteers with low back pain of greater than or equal to 1 month 's duration were randomized to receive custom orthotics ( group A ) or a flat insole sham ( group B ) with limited chiropractic care in 5 visits over 4 weeks .


Primary outcome measures are as follows : Quadruple Numerical Pain Rating Scale ( for back ) , the Roland-Morris Disability Questionnaire , the number of muscles grade 4 or lower on manual muscle testing , and the number of spinal fixations detected by motion palpation and vertebral challenge at intake ( B1 ) , 2 weeks later before treatment began and orthotic use was initiated ( B2 ) and before each subsequent treatment at approximately days 3 , 10 , 17 , and 24 after B2 .


Secondary outcome measures are correlations of all primary outcomes .


Both groups improved on all Numerical Pain Rating Scale , Roland-Morris Disability Questionnaire , and the number of muscles from intake ( B1 ) to final visit .


Only group B yielded significant improvements in the number of spinal fixations .


No outcome measures showed statistical difference between groups at any time point ; however , those who wore custom orthotics longer each day showed trends toward greater improvements in some outcome measures .


Both groups improved with chiropractic care including spinal manipulation ; however , there were no statistical differences shown between sham and custom orthotic groups .


Future studies should formally measure the time that orthotics or shams are worn in a weight-bearing capacity each day .


We aimed to test the effectiveness of checklists for emergency procedures on medical staff performance in intensive care crises .


This is a prospective single-center randomized trial in a high-fidelity simulation center modeling an intensive care unit ( ICU ) in a tertiary care hospital in Germany .


Teams consisted of 1 ICU resident and 2 ICU nurses ( in total , n = 48 ) .


All completed 4 crisis scenarios , in which they were randomized to use checklists or to perform without any aid .


In 2 of the scenarios , checklists could be used immediately ( type 1 scenarios ) ; and for the remaining , some further steps , for example , confirming diagnosis , were required first ( type 2 scenarios ) .


Outcome measurements were number of predefined items and time to completion of more than 50 % and more than 75 % of steps , respectively .


When using checklists , participants initiated items faster and more completely according to appropriate treatment guidelines ( 9 vs 7 items with and without checklists , P < .05 ) .


Benefit of checklists was better in type 2 scenarios than in type 1 scenarios ( 2 vs 1 additional item , P < .05 ) .


In type 2 scenarios , time to complete 50 % and 75 % of items was faster with the use of checklists ( P < .005 ) .


Use of checklists in ICU crises has a benefit on the completion of critical treatment steps .


Within the type 2 scenarios , items were fulfilled faster with checklists .


The implementation of checklists for intensive care crises is a promising approach that may improve patients ' care .


Rapid reversal of vitamin K antagonist ( VKA ) - induced anticoagulation is often necessary for patients needing urgent surgical or invasive procedures .


The optimum means of VKA reversal has not been established in comparative clinical trials .


We compared the efficacy and safety of four-factor prothrombin complex concentrate ( 4F-PCC ) with that of plasma in VKA-treated patients needing urgent surgical or invasive procedures .


In a multicentre , open-label , phase 3b randomised trial we enrolled patients aged 18 years or older needing rapid VKA reversal before an urgent surgical or invasive procedure .


We randomly assigned patients in a 1:1 ratio to receive vitamin K concomitant with a single dose of either 4F-PCC ( Beriplex/Kcentra/Confidex ; CSL Behring , Marburg , Germany ) or plasma , with dosing based on international normalised ratio ( INR ) and weight .


The primary endpoint was effective haemostasis , and the co-primary endpoint was rapid INR reduction ( 13 at 05 h after infusion end ) .


The analyses were intended to evaluate , in a hierarchical fashion , first non-inferiority ( lower limit 95 % CI greater than -10 % for group difference ) for both endpoints , then superiority ( lower limit 95 % CI > 0 % ) if non-inferiority was achieved .


Adverse events and serious adverse events were reported to days 10 and 45 , respectively .


This trial is registered at ClinicalTrials.gov , number NCT00803101 .


181 patients were randomised ( 4F-PCC n = 90 ; plasma n = 91 ) .


The intention-to-treat efficacy population comprised 168 patients ( 4F-PCC , n = 87 ; plasma , n = 81 ) .


Effective haemostasis was achieved in 78 ( 90 % ) patients in the 4F-PCC group compared with 61 ( 75 % ) patients in the plasma group , demonstrating both non-inferiority and superiority of 4F-PCC over plasma ( difference 143 % , 95 % CI 28-258 ) .


Rapid INR reduction was achieved in 48 ( 55 % ) patients in the 4F-PCC group compared with eight ( 10 % ) patients in the plasma group , demonstrating both non-inferiority and superiority of 4F-PCC over plasma ( difference 453 % , 95 % CI 319-564 ) .


The safety profile of 4F-PCC was generally similar to that of plasma ; 49 ( 56 % ) patients receiving 4F-PCC had adverse events compared with 53 ( 60 % ) patients receiving plasma .


Adverse events of interest were thromboembolic adverse events ( six [ 7 % ] patients receiving 4F-PCC vs seven [ 8 % ] patients receiving plasma ) , fluid overload or similar cardiac events ( three [ 3 % ] patients vs 11 [ 13 % ] patients ) , and late bleeding events ( three [ 3 % ] patients vs four [ 5 % ] patients ) .


4F-PCC is non-inferior and superior to plasma for rapid INR reversal and effective haemostasis in patients needing VKA reversal for urgent surgical or invasive procedures .


CSL Behring .


Major depressive disorder ( MDD ) places a significant disease burden on individuals as well as on societies .


Several web-based interventions for MDD have shown to be effective in reducing depressive symptoms .


However , it is not known whether web-based interventions , when used as adjunctive treatment tools to regular psychotherapy , have an additional effect compared to regular psychotherapy for depression .


This study is a currently recruiting pragmatic randomized controlled trial ( RCT ) that compares regular psychotherapy plus a web-based depression program ( `` deprexis '' ) with a control condition exclusively receiving regular psychotherapy .


Adults with a depressive disorder ( N = 800 ) will be recruited in routine secondary care from therapists over the course of their initial sessions and will then be randomized within therapists to one of the two conditions .


The primary outcome is depressive symptoms measured with the Beck Depression Inventory ( BDI-II ) at three months post randomization .


Secondary outcomes include changes on various indicators such as anxiety , somatic symptoms and quality of life .


All outcomes are again assessed at the secondary endpoint six months post randomization .


In addition , the working alliance and feasibility/acceptability of the treatment condition will be explored .


This is the first randomized controlled trial to examine the feasibility/acceptability and the effectiveness of a combination of traditional face-to-face psychotherapy and web-based depression program compared to regular psychotherapeutic treatment in depressed outpatients in routine care .


ISRCTN20165665 .


To the best of our knowledge , no study has examined the effects of vitamin D-calcium cosupplementation on inflammatory biomarkers and adipocytokines in vitamin D-insufficient type 2 diabetics .


This study was performed to assess the effects of vitamin D and calcium supplementation on inflammatory biomarkers and adipocytokines in vitamin D-insufficient people with type 2 diabetes .


Totally , 118 diabetic patients were enrolled in this randomized , placebo-controlled clinical trial .


After matching for age , sex , body mass index , type and dose of hypoglycemic agents , and duration of diabetes , subjects were randomly assigned into 4 groups receiving the following : 1 ) 50000 IU/wk vitamin D + calcium placebo ; 2 ) 1000 mg/d calcium + vitamin D placebo ; 3 ) 50 000 IU/wk vitamin D + 1000 mg/d calcium ; or 4 ) vitamin D placebo + calcium placebo for 8 weeks .


Blood sampling was done for the quantification of inflammatory biomarkers and adipocytokines at the study baseline and after 8 weeks of intervention .


Calcium ( changes from baseline : -75 19 ng/ml , P = .01 ) and vitamin D alone ( -56 19 ng/mL , P = .01 ) and joint calcium-vitamin D supplementation ( -92 19 ng/mL , P = .01 ) resulted in a significant reduction in serum leptin levels compared with placebo ( -9 18 ng/mL ) .


This was also the case for serum IL-6 , such that calcium ( -2 1 pg/mL , P < .001 ) and vitamin D alone ( -4 1 pg/mL , P < .001 ) and their combination ( -4 1 pg/mL , P < .001 ) led to significant reductions compared with placebo ( 3 1 pg/mL ) .


After adjustment for potential confounders , individuals in the calcium ( -3.1 1.3 , P < .05 ) , vitamin D ( -3.1 1.3 , P < .05 ) , and joint calcium-vitamin D groups ( -3.4 1.3 , P < .05 ) had greater reductions in serum TNF - concentrations compared with placebo ( 0.1 1.2 ) .


Individuals who received joint calcium-vitamin D supplements tended to have a decrease in serum high-sensitivity C-reactive protein levels compared with placebo after controlling for baseline levels ( -1.14 0.25 vs 0.02 0.24 ng/mL , P = .09 ) .


Joint calcium-vitamin D supplementation might improve systemic inflammation through decreasing IL-6 and TNF - concentrations in vitamin D-insufficient people with type 2 diabetes .


There has not been sufficient data to evaluate the serial vascular healing pattern after everolimus-eluting stent ( EES ) implantation .


Using optical coherence tomography , we compared serial changes in strut coverage of the EES and the first-generation sirolimus-eluting stent ( SES ) .


Sixty patients were randomly assigned to receive either EES ( n = 30 ) or first-generation SES ( n = 30 ) for coronary artery disease .


Serial optical coherence tomography evaluation immediately after the procedure , and 3 - and 12-month follow-ups were performed in 50 patients with 54 stents ( 25 patients with 28 EES vs. 25 patients with 26 SES ) .


The percentage of uncovered struts was defined as the ratio of uncovered struts to total struts .


The primary end point was the percentage of uncovered struts at 12-month follow-up .


The secondary primary end point was the percentage of uncovered struts at the 3-month follow-up and the comparative percentage change ( ) of uncovered struts at 3 - and 12-month follow-ups of EES vs SES .


The percentage of uncovered struts was significantly lower in the EES group compared with the SES group ( median value , 6.9 % ; interquartile range [ IQR ] , 3.9-10 .6 % vs. 11.1 % ; IQR , 5.5-29 .4 % , respectively ) at the 3-month follow-up ( P = 0.03 ) , and at the 12-month follow-up ( median value , 1.3 % ; IQR , 0.3-3 .5 % vs. 3.6 % ; IQR , 1.0-9 .4 % ; P = 0.02 ) .


The percentage of uncovered struts from the 3 - to the 12-month follow-up was similar ( -7.0 6.9 % in EES vs. -10.5 13.6 % in SES ; P = 0.24 ) .


The EES group showed more favourable stent strut coverage than the first-generation SES group at the early and late periods after stent implantation .


These findings suggest that EES have a more beneficial effect for vascular healing .


Perineural dexamethasone has been investigated as an adjuvant for brachial plexus nerve blocks , but it is not known whether the beneficial effect of perineural dexamethasone on analgesia duration leads to a better quality of surgical recovery .


We hypothesized that patients receiving dexamethasone would have a better quality of recovery than patients not receiving dexamethasone .


We also sought to compare the effect of perineural with that of IV dexamethasone on block characteristics .


Patients undergoing elective ankle and foot surgery were recruited over a 9-month period .


Patients received ultrasound-guided sciatic nerve blocks by using 0.5 % bupivacaine with epinephrine 1:300,000 ( 0.45 mL/kg ) and were randomized into 3 groups : group 1 = perineural dexamethasone 8 mg/2 mL with 50 mL IV normal saline , group 2 = perineural saline/2 mL with IV 8 mg dexamethasone in 50 mL normal saline , and group 3 = perineural saline/2 mL with 50 mL normal saline .


The primary outcome was the global score in the quality of recovery ( QoR-40 ) .


The secondary outcomes included analgesia duration , opioid consumption , patient satisfaction , numeric pain rating scores , and postoperative neurologic symptoms .


Eighty patients were randomized , and 78 patients completed the study protocol .


There was no improvement in the global QoR-40 score at 24 hours between the perineural dexamethasone and saline , median ( 97.5 % CI ) difference of -3 ( -7 to 3 ) ; IV dexamethasone and saline , median difference of -1 ( -8 to 5 ) ; or perineural dexamethasone and IV dexamethasone median difference of -2 ( -6 to 5 ) .


Analgesia duration ( P < 0.001 ) and time to first toe movement ( P < 0.001 ) were prolonged by perineural dexamethasone compared with saline .


IV dexamethasone prolonged time to first toe movement compared with saline ( P = 0.008 ) but not analgesia duration ( P = 0.18 ) .


There was no significant difference in the time to first toe movement or analgesia duration between the perineural and IV dexamethasone groups .


Postoperative opioid consumption was not different among study groups .


Self-reported neurologic symptoms at 24 hours were not different among perineural dexamethasone ( 17 , 63 % ) , IV dexamethasone ( 10 , 42 % ) , or normal saline ( 8 , 30 % ) ( P = 0.31 ) .


All postoperative neurologic sequelae were resolved by 8 weeks .


Preoperative administration of IV and perineural dexamethasone compared with saline did not improve overall QoR-40 or decrease opioid consumption but did prolong analgesic duration in patients undergoing elective foot and ankle surgery and receiving sciatic nerve block .


Given the lack of clinical benefit and the concern of dexamethasone neurotoxicity as demonstrated in animal studies , the practice of perineural dexamethasone administration needs to be further evaluated .


Stroke has a huge impact , leaving more than a third of affected people with lasting disability and rehabilitation remains a cornerstone treatment in the National Health Service ( NHS ) .


Recovery of mobility and arm function post-stroke occurs through re-learning to use the affected body parts and/or learning to compensate with the lesser affected side .


Promising evidence suggests that the addition of Co-careldopa to physical therapy and occupational therapy may improve the recovery of arm and leg movement and lead to improved function .


Dopamine Augmented Rehabilitation in Stroke ( DARS ) is a multi-centre double-blind , randomised , placebo , controlled clinical trial of Co-careldopa in addition to routine NHS occupational therapy and physical therapy as part of early stroke rehabilitation .


Participants will be randomised on a 1:1 basis to either Co-careldopa or placebo .


The primary objective of the trial is to determine whether the addition of six weeks of Co-careldopa treatment to rehabilitation therapy can improve the proportion of patients who can walk independently eight weeks post-randomisation .


The DARS trial will provide evidence as to whether Co-careldopa , in addition to routine NHS occupational and physical therapy , leads to a greater recovery of motor function , a reduction in carer dependency and advance rehabilitation treatments for people with stroke .


ISRCTN99643613 assigned on 4 December 2009 .


A pilot study was conducted to assess the acceptability and feasibility of a breast milk expression education and support intervention in mothers of preterm infants and study procedures .


Forty mothers of preterm infants born at less than 30 weeks of gestation .


Pilot randomized controlled trial .


Mothers of preterm infants were randomly allocated to the breast milk expression education and support intervention or standard care .


The experimental intervention encompassed a breast milk expression education session on 7 themes , telephone follow-up , and telephone helpline .


Data related to the acceptability and feasibility of the intervention and study procedures were collected throughout the study .


At the end of the study , mothers allocated to the experimental intervention completed a self-report questionnaire assessing the acceptability of each of the intervention components .


It was feasible to recruit 70 % of eligible mothers and retain 83 % of mothers who consented to participate in the study .


Mothers reported that all the intervention components were appropriate and effective in supporting their breast milk production .


Although the reliability of the data collection method was demonstrated , the fidelity of the telephone follow-up faced some challenges .


Both the intervention and study procedures were acceptable and feasible .


Improvements related to the fidelity of the intervention would ensure the feasibility and internal validity of a larger-scale trial .


We assessed the effects of left dorsolateral prefrontal cortex transcranial direct current stimulation ( DLPF-tDCS ) on Coma Recovery Scale-Revised ( CRS-R ) scores in severely brain-damaged patients with disorders of consciousness .


In a double-blind sham-controlled crossover design , anodal and sham tDCS were delivered in randomized order over the left DLPF cortex for 20 minutes in patients in a vegetative state/unresponsive wakefulness syndrome ( VS/UWS ) or in a minimally conscious state ( MCS ) assessed at least 1 week after acute traumatic or nontraumatic insult .


Clinical assessments were performed using the CRS-R directly before and after anodal and sham tDCS stimulation .


Follow-up outcome data were acquired 12 months after inclusion using the Glasgow Outcome Scale-Extended .


Patients in MCS ( n = 30 ; interval 43 63 mo ; 19 traumatic , 11 nontraumatic ) showed a significant treatment effect ( p = 0.003 ) as measured by CRS-R total scores .


In patients with VS/UWS ( n = 25 ; interval 24 48 mo ; 6 traumatic , 19 nontraumatic ) , no treatment effect was observed ( p = 0.952 ) .


Thirteen ( 43 % ) patients in MCS and 2 ( 8 % ) patients in VS/UWS further showed postanodal tDCS-related signs of consciousness , which were observed neither during the pre-tDCS evaluation nor during the pre - or post-sham evaluation ( i.e. , tDCS responders ) .


Outcome did not differ between tDCS responders and nonresponders .


tDCS over left DLPF cortex may transiently improve signs of consciousness in MCS following severe brain damage as measured by changes in CRS-R total scores .


This study provides Class II evidence that short-duration tDCS of the left DLPF cortex transiently improves consciousness as measured by CRS-R assessment in patients with MCS .


Obese men with normal semen parameters exhibit reduced fertility but few prospective data are available .


This study aimed to determine the effect of male factors and body mass among the Pregnancy in Polycystic Ovary Syndrome II ( PPCOS II ) participants .


This is a secondary analysis of the PPCOS II trial .


A total of 750 infertile women with polycystic ovary syndrome ( PCOS ) were randomly assigned to up to receive five cycles of letrozole or clomiphene citrate .


Females were 18-39-years-old and had a male partner with sperm concentration of at least 14 million/mL who consented to regular intercourse .


Analysis was limited to couples with complete male partner information ( n = 710 ) .


Male body mass index ( BMI ) was higher in couples who failed to conceive ( 29.5 kg/m ( 2 ) vs 28.2 kg/m ( 2 ) ; P = .039 ) as well as those who did not achieve a live birth ( 29.5 kg/m ( 2 ) vs 28.1 kg/m ( 2 ) ; P = .047 ) .


At least one partner was obese in 548 couples ( 77.1 % ) .


A total of 261 couples were concordant for obesity ( 36.8 % ) .


After adjustment for female BMI , the association of male BMI with live birth was no longer significant ( odds ratio [ OR ] = 0.85 ; 95 % confidence interval [ CI ] , 0.68-1 .05 ; P = .13 ) .


Couples in which both partners smoked had a lower chance of live birth vs nonsmokers ( OR = 0.20 ; 95 % CI , 0.08-0 .52 ; P = .02 ) , whereas there was not a significant effect of female or male smoking alone .


Live birth was more likely in couples with at least three sexual intercourse attempts over the previous 4 weeks ( reported at baseline ) as opposed to couples with lesser frequency ( OR = 4.39 ; 95 % CI , 1.52-12 .4 ; P < .01 ) .


In this large cohort of obese women with PCOS , effect of male obesity was explained by female BMI .


Lower chance of success was seen among couples where both partners smoked .


Obesity and smoking are common among women with PCOS and their partners and contribute to a decrease in fertility treatment success .


To assess risk factors associated with substantial microbial bioburden of lids , conjunctivae , contact lenses , and storage cases during daily wear of silicone hydrogel contact lenses .


Two hundred eighteen patients were fit to lotrafilcon A lenses , randomized to use either a multipurpose solution or a hydrogen peroxide care system , and followed up for 1 year .


Lenses , lens transport saline , lids , conjunctivae , and storage cases were cultured and considered to have substantial microbial bioburden when they harbored high levels of commensal or pathogenic organisms .


Univariate and multivariate logistic regression analyses were conducted to examine which demographic covariates were associated with significant bioburden at each location while controlling for solution use .


In multivariate analyses , smoking trended toward an association with lens bioburden ( odds ratio [ OR ] = 2.15 , 95 % confidence interval [ CI ] : 0.95-4 .88 ) .


Clerical occupations were found to be associated with more frequent overall storage case contamination ( OR = 3.51 , 95 % CI : 1.15-10 .70 ) and , specifically , higher gram-positive storage case contamination ( OR = 5.57 , 95 % CI : 1.82-17 .06 ) .


The peroxide system was associated with more frequent storage case contamination ( OR = 7.6 , 95 % CI : 3.79-15 .19 ) .


Coagulase-negative staphylococci ( CNS ) were the most frequently cultured organisms within storage cases , and in multivariate analyses , CNS were more frequently found in storage cases of peroxide users ( OR = 6.12 , 95 % CI : 2.91-13 .09 ) .


Clerical occupations were associated with increased microbial bioburden of storage cases during daily wear of silicone hydrogel lenses .


Smoking may increase the risk of lens contamination .


Storage cases are most frequently contaminated with normal skin flora , and peroxide cases were associated with more frequent contamination .


However , the solution type was not associated with lid or lens contamination nor with corneal infiltrative events in this study .


Training-induced cognitive bias may affect performance .


Using a simulation-based emergency airway curriculum , we tested the hypothesis that curriculum design would induce bias and affect decision making .


Twenty-three novice anesthesiology residents were randomized into 2 groups .


The primary outcome measure was the initiation of supraglottic airway and cricothyroidotomy techniques in a simulated cannot-ventilate , cannot-intubate scenario during 3 evaluation sessions .


Secondary outcomes were response times for device initiation .


After a baseline evaluation and didactic lecture , residents received an initial practical training in either surgical cricothyroidotomy ( CRIC group ) or supraglottic airway ( SGA group ) .


After the midtest , the groups switched to receive the alternate training .


From baseline to midtest , the SGA group increased initiation of supraglottic airway but not cricothyroidotomy .


The CRIC group increased initiation of cricothyroidotomy but not supraglottic airway .


After completion of training in both techniques , the SGA group increased initiation of both supraglottic airway and cricothyroidotomy .


In contrast , the CRIC group increased initiation of cricothyroidotomy but failed to change practice in supraglottic airway .


Final test response times showed that the CRIC group was slower to initiate supraglottic airway and faster to initiate cricothyroidotomy .


Practical training in only 1 technique caused bias in both groups despite a preceding didactic lecture .


The chief finding was an asymmetrical effect of training sequence even after training in both techniques .


Initial training in cricothyroidotomy caused bias that did not correct despite subsequent supraglottic airway training .


Educators must be alert to the risk of inducing cognitive bias when designing curricula .


Gastric sonography can provide information about gastric content and volume that can help determine aspiration risk at the bedside .


The primary objective of this study is to assess the intrarater and interrater reliability of a previously validated method of gastric volume assessment based on gastric antral area .


The secondary objective is to evaluate the agreement between two different methods to measure gastric antral area .


Three independent raters performed a standardized gastric ultrasound assessment in healthy subjects who had been randomly allocated to ingest a predetermined volume of clear fluid ( apple juice ) from 0 to 400 ml .


Each rater measured the gastric antral area , using twice the two-diameter method and twice the free-tracing method .


The rater order was allocated at random and raters were unaware of the volume ingested and of one-another 's measurements .


The Guidelines for Reporting Reliability and Agreement Studies were followed for conducting and reporting this study .


Twenty-two volunteers were studied .


Ultrasound assessment of antral cross-sectional area and volume was found to have `` nearly perfect '' intrarater and interrater reliability ( correlation coefficient > 0.8 ) with maximum differences within 13 % .


A Bland-Altman analysis suggests that the free-tracing method and the two-diameter method are essentially equivalent , within a clinically acceptable level of agreement .


Ultrasound assessment of gastric volume by clinical anesthesiologists is highly reproducible with high intrarater and interrater reliability .


The free-tracing method to measure antral cross-sectional area is equivalent to the two-diameter method .


Although childhood sexual and/or physical abuse ( CSA/CPA ) is known to have severe psychopathological consequences , there is little evidence on psychotherapeutic interventions for adolescents and young adults suffering from post-traumatic stress disorder ( PTSD ) .


Equally sparse are data on moderators of treatment response on PTSD-related epigenetic changes , health care costs and loss of productivity , alterations in cognitive processing , and on how successful interventions affect all of these factors .


Early treatment may prevent later ( co ) morbidity .


In this paper , we present a study protocol for the evaluation of a newly developed psychotherapeutic manual for PTSD after CSA/CPA in adolescents and young adults - the Developmentally Adapted Cognitive Processing Therapy ( D-CPT ) .


In a multicenter randomized controlled trial ( RCT ) D-CPT is compared to treatment as usual ( TAU ) .


A sample of 90 adolescent outpatients aged 14 to 21 years will be randomized to one of these conditions .


Four assessments will be carried out at baseline , at end of treatment , and 3 and 6 months after end of therapy .


Each time , patients will be assessed via clinical interviews and a wide range of questionnaires .


In addition to PTSD symptoms and comorbidities , we will evaluate moderators of treatment response , epigenetic profiles , direct and indirect costs of this disorder , and neurophysiological processing of threat cues in PTSD and their respective changes in the course of these two treatments ( D-CPT and TAU ) .


The study will provide new insights in the understudied field of PTSD in adolescents and young adults .


A newly developed intervention will be evaluated in this therapeutically underserved population .


Results will provide data on treatment efficacy , direct and indirect treatment costs , as well as on associations of treatment outcome and PTSD intensity both to epigenetic profiles and to the neurobiological processing of threat cues .


Besides , they will help to learn more about the psychopathology and possible new objective correlates of PTSD .


Germanctr.de identifier : DRKS00004787 .


Ulcerative colitis ( UC ) is associated with an increased risk of colorectal cancer .


Chromoendoscopy showed superiority to conventional colonoscopy ( CC ) in surveillance studies including high-risk patients .


We aimed to compare chromoendoscopy-guided endomicroscopy ( CGE ) with CC for intraepithelial neoplasia ( IN ) detection in patients with longstanding UC without primary sclerosing cholangitis and/or history of IN .


One hundred sixty-two patients with longstanding ( 8 yr ) distal/extensive UC and without primary sclerosing cholangitis and/or history of IN were prospectively randomized to undergo CGE ( group A ) or CC ( group B ) .


Seventeen patients were excluded .


In group A ( n = 72 ) , circumscribed lesions highlighted by pan-chromoendoscopy were evaluated by endomicroscopy , and targeted biopsy/polypectomy was performed .


In group B ( n = 73 ) , 4 random biopsies every 10 cm and targeted biopsy/polypectomy of detected lesions were performed .


Thirteen IN , all low grade , were detected : 7 IN in group A and 6 in group B ( P > 0.05 ) , distributed , respectively , by 6 and 4 patients ( P > 0.05 ) .


Significantly , more biopsies were performed in group B ( 4.7 4.9 versus 36.0 6.2 , P < 0.001 ) , and the per-biopsy yield of IN was higher in group A ( 1/48 versus 1/438 , P < 0.001 ) .


Examination time was 61.5 15.6 minutes in group A and 40.7 8.7 minutes in group B ( P < 0.001 ) .


The IN detection by endomicroscopy revealed : sensitivity = 85.7 % , specificity = 97.9 % , positive predictive value = 75.0 % , and negative predictive value = 98.9 % .


CGE does not improve the detection of IN in the endoscopic screening of patients with longstanding UC without primary sclerosing cholangitis and/or history of IN .


CGE takes longer than CC , but it decreases the number of biopsies performed and significantly increases the per-biopsy yield of IN .


Endomicroscopy is an accurate tool for IN detection .


Age-associated declines in muscle mass and function are major risk factors for an impaired ability to carry out activities of daily living , falls , prolonged recovery time after hospitalization , and mortality in older adults .


New strategies that can slow the age-related loss of muscle mass and function are needed to help older adults maintain adequate performance status to reduce these risks and maintain independence .


We evaluated the efficacy of fish oil-derived n-3 ( -3 ) PUFA therapy to slow the age-associated loss of muscle mass and function .


Sixty healthy 60-85-y-old men and women were randomly assigned to receive n-3 PUFA ( n = 40 ) or corn oil ( n = 20 ) therapy for 6 mo. .


Thigh muscle volume , handgrip strength , one-repetition maximum ( 1-RM ) lower - and upper-body strength , and average power during isokinetic leg exercises were evaluated before and after treatment .


Forty-four subjects completed the study [ 29 subjects ( 73 % ) in the n-3 PUFA group ; 15 subjects ( 75 % ) in the control group ] .


Compared with the control group , 6 mo of n-3 PUFA therapy increased thigh muscle volume ( 3.6 % ; 95 % CI : 0.2 % , 7.0 % ) , handgrip strength ( 2.3 kg ; 95 % CI : 0.8 , 3.7 kg ) , and 1-RM muscle strength ( 4.0 % ; 95 % CI : 0.8 % , 7.3 % ) ( all P < 0.05 ) and tended to increase average isokinetic power ( 5.6 % ; 95 % CI : -0.6 % , 11.7 % ; P = 0.075 ) .


Fish oil-derived n-3 PUFA therapy slows the normal decline in muscle mass and function in older adults and should be considered a therapeutic approach for preventing sarcopenia and maintaining physical independence in older adults .


This study was registered at clinicaltrials.gov as NCT01308957 .


In HIV-HCV co-infected patients who failed to achieve sustained viral response ( SVR ) with PEG-IFN + RBV , data on SVR rate after re-treatment with Peginterferon ( PEG-IFN ) + ribavirin ( RBV ) are scarce .


The aim of this study was to identify factors predictive of SVR after re-treatment in a large cohort of HIV/HCV co-infected patients - the ANRS-CO7 Ribavic cohort study , which is a long term follow-up study of patients who were included in the randomized controlled trial ANRS-HC02 RIBAVIC .


Among the 176 patients who did not achieve a SVR during the RIBAVIC trial , sixty-six patients ( 38 % ) experienced a re-treatment with PEG-IFN + RBV .


The SVR observed to the second course of HCV treatment was 44 % overall , i.e. 93 % in patients who were relapsers and 29 % in nonresponders .


In the nonresponders subgroup , the SVR rate was 42 % in patients with genotype 2-3 and 26 % in patients with genotype 1-4 .


In multivariate analysis , age 40 years ( OR 12.4 95 % CI 1.9-171 , p = 0.003 ) , genotype 2-3 versus 1-4 ( OR 8.1 95 % CI 8.1 1.2-97 , p = 0.002 ) and relapser status at first treatment ( OR 32.9 95 % CI 3.2-278 , p < 0.0001 ) were significantly associated with SVR .


Our findings strongly suggest that patients who relapse after first treatment , particularly those infected with HCV genotype 2-3 , or living in countries with no access to the direct acting antiviral drugs for HCV , could be successfully re-treated with standard bi-therapy of PEG-IFN + RBV regimen .


To evaluate two different treatment systems with regard to incisor position , transverse dimension changes in maxillary arch , changes in maxillary molar inclinations , clinical periodontal parameters , and pain intensity in patients with a Class I malocclusion .


Seventeen patients ( with a mean age of 14.5 years ) underwent orthodontic treatment with the Roth prescribed edgewise bracket systems after expanding the maxillary arch with a quad-helix appliance , and 16 patients ( with a mean age of 14.8 years ) underwent orthodontic treatment with the Damon 3MX bracket system .


Each subject 's lateral cephalometric and posteroanterior radiographs and dental casts were obtained at the beginning of the treatment and after debonding .


In addition to these , the periodontal index and pain scores were taken .


Cephalometric data showed that in both treatment systems , overjet value decreased and maxillary and mandibular incisors proclined .


Posteroanterior measurements demonstrated a greater increase in the maxillary molar inclination in the Damon group .


Significant increase of maxillary intercanine , interpremolar , and intermolar widths was shown in both systems .


Periodontal index and pain score changes between different observation periods were the same .


The conventional and Damon systems were found similar with regard to the incisor position , transverse dimension changes in maxillary arch , clinical periodontal parameters , and pain intensity .


The only significant difference was that the Damon system inclined the maxillary molars more buccally than the conventional group .


Strategies are needed to improve medication management among vulnerable populations .


We tested the effect of providing illustrated , plain-language medication lists on medication understanding , adherence , and satisfaction among Latino patients with diabetes in a safety net clinic .


Randomized controlled trial .


Intervention patients received a PictureRx illustrated medication list that depicted the medication , indication , and dosing instructions , accompanied by plain language bilingual text .


Usual care patients received a written list of their medications in their preferred language , with indication but no images .


Outcomes were assessed by telephone approximately 1 week later .


The Medication Understanding Questionnaire measured patients ' ability to report the indication , strength , dosing , and frequency for their medication regimen .


Self-reported adherence and satisfaction were secondary outcomes .


Analysis was performed by intention to treat .


Of 200 enrolled participants , 197 ( 98.5 % ) completed follow-up .


Most ( 71 % ) had not graduated high school , and 59 % had low health literacy .


Patients randomized to illustrated medication instructions had better overall understanding of their medications ( P < .001 ) , including greater ability to report the drug indication ( P < .01 ) , strength ( P < .05 ) , dosing ( P < .01 ) , and frequency of administration ( P < .001 ) .


Self-reported adherence did not differ significantly between study groups .


Patients who received illustrated medication lists were very satisfied with them .


In this randomized controlled trial , patients who received illustrated , plain-language medication lists demonstrated significantly greater understanding of their medication regimen .


Such tools have the potential to improve medication use and chronic disease control , as well as reduce health disparities-although this requires further study .


To investigate the effect of Soothing liver therapy on infertile women undergoing in vitro fertilization and embryo transfer ( IVF-ET ) and to explore its mechanism .


Fifty-eight women with tubal infertility were randomized into two groups : 30 in an experimental group treated with Xiaoyao powder ( Shugan ) plus gonadotropin-releasing hormone analog ( GnRHa ) / follicle-stimulating hormone ( FSH ) / human chorionic gonadotropin ( hCG ) and 28 in the control group who were treated with GnRHa/FSH / hCG only .


The total gonadotropin ( Gn ) doses required , endometrial thickness , oocyte numbers , high quality embryo production rate and pregnancy rate of the two groups were compared .


The concentration of growth differentiation factor-9 ( GDF-9 ) in follicular fluid was detected by western blotting and the expression of GDF-9 mRNA in granulosa cells was measured using reverse transcription-polymerase chain reaction amplification .


In the experimental group , the Gn dose was significantly lower than that in the control group ; the endometrial thickness , high quality embryo production and pregnancy rates were significantly higher and the expression of GDF-9 mRNA was also significantly higher than in the control group ( all P < 0.05 ) .


Shugan treatment can improve the pregnancy rate of women with tubal infertility ; its mechanism is possibly related to the increased expression of GDF-9 in granulosa cells .


To compare the effects of horizontal and vertical vaginal cuff closure techniques on vagina length after vaginal hysterectomy .


Prospective randomized study ( Canadian Task Force classification I ) .


Teaching and research hospital , a tertiary center .


Fifty-two women with POP-Q stage 0 or 1 uterine prolapse were randomized into 2 groups using vertical ( n = 26 ) or horizontal ( n = 26 ) vaginal cuff closure .


All patients underwent vaginal hysterectomy .


Vagina length in the 2 groups was compared preoperatively , immediately after surgery , and at 6 weeks postoperatively .


Mean ( SD ) preoperative vagina length in the horizontal and vertical groups was similar ( 7.87 [ 0.92 ] cm vs 7.99 [ 0.78 ] cm ; p = .41 ) .


Immediately postoperatively , the vagina was significantly shorter in the horizontal group than in the vertical group ( 6.61 [ 0.89 ] cm vs 7.51 [ 0.74 ] cm ; p < .001 ) .


At 6 weeks postoperatively , the vagina was still significantly shorter in the horizontal group ( 6.55 [ 0.89 ] cm vs 7.42 ( 0.73 ) cm ; p < .001 ) .


The mean difference in vagina length before and after surgery was also significantly higher in the horizontal group than in the vertical group ( -1.26 [ 0.12 ] cm vs 0.49 [ 0.11 ] cm ; p < .001 ) .


Vertical cuff closure during vaginal hysterectomy seems to preserve vagina length better than does horizontal cuff closure .


Information on benefits and risks of drugs is a key element affecting doctors ' prescribing decisions .


Outreach visits promoting independent information have proved moderately effective in changing prescribing behaviours .


Testing the short and long-term effectiveness on general practitioners ' prescribing of small groups meetings led by pharmacists .


Two cluster open randomised controlled trials ( RCTs ) were carried out in a large scale NHS setting .


Ad hoc prepared evidence based material were used considering a therapeutic area approach -- TEA , with information materials on osteoporosis or prostatic hyperplasia -- and a single drug oriented approach -- SIDRO , with information materials on me-too drugs of 2 different classes : barnidipine or prulifloxacin .


In each study , all 115 Primary Care Groups in a Northern Italy area ( 2.2 million inhabitants , 1737 general practitioners ) were randomised to educational small groups meetings , in which available evidence was provided together with drug utilization data and clinical scenarios .


Main outcomes were changes in the six-months prescription of targeted drugs .


Longer term results ( 24 and 48 months ) were also evaluated .


In the TEA trial , one of the four primary outcomes showed a reduction ( prescription of alfuzosin compared to tamsulosin and terazosin in benign prostatic hyperplasia : prescribing ratio -8.5 % , p = 0.03 ) .


Another primary outcome ( prescription of risedronate ) showed a reduction at 24 and 48 months ( -7.6 % , p = 0.02 ; and -9,8 % , p = 0.03 ) , but not at six months ( -5.1 % , p = 0.36 ) .


In the SIDRO trial both primary outcomes showed a statistically significant reduction ( prescription of barnidipine -9.8 % , p = 0.02 ; prescription of prulifloxacin -11.1 % , p = 0.04 ) , which persisted or increased over time .


These two cluster RCTs showed the large scale feasibility of a complex educational program in a NHS setting , and its potentially relevant long-term impact on prescribing habits , in particular when focusing on a single drug .


National Health systems should invest in independent drug information programs .


Controlled-Trials .


com ISRCTN05866587 .


There are no long-term medical treatments for uterine fibroids , and non-invasive biomarkers are needed to evaluate novel therapeutic interventions .


The aim of this study was to determine whether serial dynamic contrast-enhanced MRI ( DCE-MRI ) and magnetization transfer MRI ( MT-MRI ) are able to detect changes that accompany volume reduction in patients administered GnRH analogue drugs , a treatment which is known to reduce fibroid volume and perfusion .


Our secondary aim was to determine whether rapid suppression of ovarian activity by combining GnRH agonist and antagonist therapies results in faster volume reduction .


Forty women were assessed for eligibility at gynaecology clinics in the region , of whom thirty premenopausal women scheduled for hysterectomy due to symptomatic fibroids were randomized to three groups , receiving ( 1 ) GnRH agonist ( Goserelin ) , ( 2 ) GnRH agonist + GnRH antagonist ( Goserelin and Cetrorelix ) or ( 3 ) no treatment .


Patients were monitored by serial structural , DCE-MRI and MT-MRI , as well as by ultrasound and serum oestradiol concentration measurements from enrolment to hysterectomy ( approximately 3 months ) .


A volumetric treatment effect assessed by structural MRI occurred by day 14 of treatment ( 9 % median reduction versus 9 % increase in untreated women ; P = 0.022 ) and persisted throughout .


Reduced fibroid perfusion and permeability assessed by DCE-MRI occurred later and was demonstrable by 2-3 months ( 43 % median reduction versus 20 % increase respectively ; P = 0.0093 ) .


There was no apparent treatment effect by MT-MRI .


Effective suppression of oestradiol was associated with early volume reduction at days 14 ( P = 0.041 ) and 28 ( P = 0.0061 ) .


DCE-MRI is sensitive to the vascular changes thought to accompany successful GnRH analogue treatment of uterine fibroids and should be considered for use in future mechanism/efficacy studies of proposed fibroid drug therapies .


GnRH antagonist administration does not appear to accelerate volume reduction , though our data do support the role of oestradiol suppression in GnRH analogue treatment of fibroids .


ClinicalTrials.gov NCT00746031 .


Dysregulated chylomicron metabolism may account for hypertriglyceridemia and increased risk of cardiovascular disease in obese subjects .


Supplementation with -3 fatty acid ethyl ester ( FAEE ) decreases plasma triglyceride .


However , its effect on postprandial chylomicron metabolism in obese subjects on a weight-loss diet has not yet been investigated .


We aimed to examine the effect of -3 FAEE supplementation on apolipoprotein ( apo ) B-48 kinetics in obese subjects on a weight-loss diet .


We carried out a 12-week , randomized trial of a hypocaloric diet plus 4 g/d -3 FAEE supplementation ( 46 % eicosapentaenoic acid and 38 % docosahexaenoic acid ) ( n = 13 ) compared with a hypocaloric diet alone ( n = 12 ) on postprandial apoB-48 kinetics in obese subjects after ingestion of an oral load .


The apoB-48 kinetics were determined using stable isotope tracer kinetics and multicompartmental modeling .


We evaluated plasma total and incremental apoB-48 0 - to 10-hour area under the curves ( AUCs ) as well as apoB-48 secretion and fractional catabolic rate .


Weight loss with or without -3 FAEE supplementation significantly reduced body weight , total fat mass , homeostasis model assessment score , fasting triglyceride concentration , postprandial triglyceride AUC , and increased plasma high-density lipoprotein cholesterol concentration ( P < .05 in all ) .


Compared with weight loss alone , weight loss plus -3 FAEE significantly ( all P < .05 ) decreased fasting triglyceride ( -11 % ) , apoB-48 ( -36 % ) concentrations , postprandial triglyceride ( -21 % ) , and apoB-48 ( -22 % ) total AUCs , as well as incremental postprandial triglyceride AUCs ( -32 % ) .


The -3 FAEE also significantly decreased apoB-48 secretion in the basal state , without a significant effect during the postprandial period ( 3-6 hours ) .


The fractional catabolic rate of apoB-48 increased with both interventions with no significant independent effect of -3 FAEE supplementation .


Addition of -3 FAEE supplementation to a moderate weight-loss diet in obese subjects can significantly improve chylomicron metabolism by independently decreasing the secretion of apoB-48 .


To compare rates of Copper T380A intrauterine device ( IUD ) utilization and satisfaction with immediate versus delayed IUD insertion after cesarean delivery in Kampala , Uganda .


This study was a randomized clinical trial of women undergoing cesarean section who desired an IUD in Kampala , Uganda .


Participants were randomly assigned to IUD insertion at the time of cesarean delivery or 6weeks afterward .


The primary outcome was IUD utilization at 6months after delivery .


Among 68 women who underwent randomization , an IUD was inserted in 100 % ( 34/34 ) of the women in the immediate insertion group and in 53 % ( 18/34 ) in the delayed group .


IUD use at 6 months was higher in the immediate insertion group ( 93 % vs. 50 % after delayed insertion ; p < .0001 ) .


Infection and expulsion were rare and did not differ between groups .


When we pooled both groups and looked at IUD users compared to nonusers , 91 % ( 39/43 ) of IUD users were satisfied or very satisfied with their contraceptive method compared to 44 % ( 11/25 ) of nonusers ( p < .0001 ) .


Women who chose not to be in the study or had the IUD removed often did so because of perceived husband or community disapproval .


The 6-month utilization of an IUD after immediate insertion was significantly higher than after delayed insertion without increased complications .


Contraceptive satisfaction was significantly higher among IUD users than nonusers .


Community and husband attitudes influence IUD utilization and continuation in Kampala , Uganda .


This work is important because it shows the safety and efficacy of providing IUDs during cesarean section in a setting where access to any healthcare , including contraception , can be extremely limited outside of childbearing and the consequences of an unintended , closely spaced pregnancy after a cesarean section can be life threatening .


Controversy exists over the prognostic significance of perihematomal edema ( PHE ) in intracerebral hemorrhage .


We aimed to determine the association of early PHE and clinical outcome among participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial ( INTERACT ) studies .


Pooled analyses of computed tomographic substudies in the pilot phase ( INTERACT1 ) and main phase ( INTERACT2 ) , both international , prospective , open , blinded end point , randomized controlled trials , of patients with spontaneous intracerebral hemorrhage ( < 6 hours ) and elevated systolic blood pressure , randomly assigned to intensive ( target systolic blood pressure , < 140 mm Hg ) or guideline-based ( systolic blood pressure , < 180 mm Hg ) blood-pressure management .


Substudy participants ( n = 1310 ; 346 INTERACT1 , 964 INTERACT2 ) had blinded central analyses of digital images from standardized baseline and 24-hour computed tomography .


Predictors of death or dependency ( modified Rankin scale scores , 3 ) at 90 days were assessed in logistic regression models and reported with odds ratios and 95 % confidence intervals .


INTERACT studies are registered at ClinicalTrials.gov ( NCT00226096 and NCT00716079 ) .


Of 1138 ( 87 % ) patients with 2 CTs available for edema analysis and outcome information , time from intracerebral hemorrhage onset to baseline computed tomography , baseline hematoma volume , 24-hour hematoma growth , and intraventricular extension were independent predictors of 24-hour PHE growth .


Absolute growth in PHE volume was significantly associated with death or dependency ( adjusted odds ratio , 1.17 ; 95 % confidence interval , 1.02-1 .33 per 5 mL increase from baseline ; P = 0.025 ) at 90 days after adjustment for demographic , clinical , and hematoma parameter prognostic factors .


Associations were consistent across various sensitivity analyses .


PHE growth is an independent prognostic factor in intracerebral hemorrhage .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT00226096 and NCT00716079 .


To prevent or combat infection , increasing the effectiveness of the immune response is highly desirable , especially in case of compromised immune system function .


However , immunostimulatory therapies are scarce , expensive , and often have unwanted side-effects .


- glucans have been shown to exert immunostimulatory effects in vitro and in vivo in experimental animal models .


Oral - glucan is inexpensive and well-tolerated , and therefore may represent a promising immunostimulatory compound for human use .


We performed a randomized open-label intervention pilot-study in 15 healthy male volunteers .


Subjects were randomized to either the - glucan ( n = 10 ) or the control group ( n = 5 ) .


Subjects in the - glucan group ingested - glucan 1000 mg once daily for 7 days .


Blood was sampled at various time-points to determine - glucan serum levels , perform ex vivo stimulation of leukocytes , and analyze microbicidal activity .


- glucan was barely detectable in serum of volunteers at all time-points .


Furthermore , neither cytokine production nor microbicidal activity of leukocytes were affected by orally administered - glucan .


The present study does not support the use of oral - glucan to enhance innate immune responses in humans .


ClinicalTrials.gov NCT01727895 .


To investigate if contact lens-related discomfort is a function of the time of day at which lenses are worn .


This was a randomized , crossover , open-label clinical trial where subjective responses , with and without contact lenses , were assessed every 2 hours during five stages ( A to E ) .


Each stage began at the time when subjects would normally have inserted their contact lenses ( T0 ) .


During stage A , no lenses were worn , whereas in stage B , lenses were worn continuously for 12 hours .


In stages C to E , lenses were worn for only 4 hours .


Contact lenses were inserted at T0 for stage C , but for stages D and E , lenses were not inserted until T0 + 4 and T0 + 8 hours , respectively .


Mixed linear models were used for statistical analysis .


In the absence of contact lenses , ocular comfort and dryness remained reasonably constant throughout the observation period .


Ocular comfort and dryness decreased during 12 hours of continuous lens wear and became significantly worse from the 8-hour time onward compared with insertion ( p < 0.023 ) .


There were no significant differences in terms of ocular comfort and dryness between any of the 4-hour lens wear stages ( p < 0.82 ) .


During each 4-hour stage , both comfort and dryness behaved in a similar fashion ( p > 0.05 ) to the first 4 hours of continuous contact lens wear .


Comparing the scores of each of these stages with the no-lens response at the corresponding time showed no significant differences for comfort ( p > 0.23 ) or dryness ( p > 0.37 ) .


Short periods of wear can be experienced at any time of day without significant change in ocular discomfort and dryness .


This suggests that subjective responses at the end of the day are determined by the length of time lenses are in contact with the eye , rather than the time of day at which lenses are worn .


To investigate a quantitative method for using radial artery pulse waveforms to assess the effect of pulsatile flow during cardiopulmonary bypass ( CPB ) .


A total of 34 adults with heart disease who underwent open-heart surgery between April 2010 and January 2011 were randomized into a pulsatile perfusion group ( n = 17 ) and a non-pulsatile perfusion group ( n = 17 ) .


Radial arterial pulse waveforms of pulsatile and non-pulsatile perfusion patients were observed and compared before and during CDB .


No pulse waveform could be detected at patients ' radial artery in both groups when the aorta was cross-clamped .


Pulse waveforms could be detected at pulsatile perfusion patients ' radial artery , but could not be detected at non-pulsatile perfusion patients ' radial artery during CPB .


Additionally , patients ' pulse waveforms during pulsatile perfusion were lower than those before the operation .


Our findings indicate that radial artery sphygmogram can be used as a valid indicator to evaluate the effectiveness of pulsatile perfusion during CPB .


The Internet is an optimal setting to provide massive access to tobacco treatments .


To evaluate open-access Web-based smoking cessation programs in a real-world setting , adherence and retention data should be taken into account as much as abstinence rate .


The objective was to analyze the usage and effectiveness of a fully automated , open-access , Web-based smoking cessation program by comparing interactive versus noninteractive versions .


Participants were randomly assigned either to the interactive or noninteractive version of the program , both with identical content divided into 4 interdependent modules .


At baseline , we collected demographic , psychological , and smoking characteristics of the smokers self-enrolled in the Web-based program of Universidad Nacional de Educacin a Distancia ( National Distance Education University ; UNED ) in Madrid , Spain .


The following questionnaires were administered : the anxiety and depression subscales from the Symptom Checklist-90-Revised , the 4-item Perceived Stress Scale , and the Heaviness of Smoking Index .


At 3 months , we analyzed dropout rates , module completion , user satisfaction , follow-up response rate , and self-assessed smoking abstinence .


A total of 23,213 smokers were registered , 50.06 % ( 11,620 / 23,213 ) women and 49.94 % ( 11,593 / 23,213 ) men , with a mean age of 39.5 years ( SD 10.3 ) .


Of these , 46.10 % ( 10,701 / 23,213 ) were married and 34.43 % ( 7992/23 ,213 ) were single , 46.03 % ( 10,686 / 23,213 ) had university education , and 78.73 % ( 18,275 / 23,213 ) were employed .


Participants smoked an average of 19.4 cigarettes per day ( SD 10.3 ) .


Of the 11,861 smokers randomly assigned to the interactive version , 2720 ( 22.93 % ) completed the first module , 1052 ( 8.87 % ) the second , 624 ( 5.26 % ) the third , and 355 ( 2.99 % ) the fourth .


Completion data was not available for the noninteractive version ( no way to record it automatically ) .


The 3-month follow-up questionnaire was completed by 1085 of 23,213 enrolled smokers ( 4.67 % ) .


Among them , 406 ( 37.42 % ) self-reported not smoking .


No difference between groups was found .


Assuming missing respondents continued to smoke , the abstinence rate was 1.74 % ( 406/23 ,213 ) , in which 22,678 were missing respondents .


Among follow-up respondents , completing the 4 modules of the intervention increased the chances of smoking cessation ( OR 1.95 , 95 % CI 1.27-2 .97 , P < .001 ) , as did smoking 30 minutes ( OR 1.58 , 95 % CI 1.04-2 .39 , P = .003 ) or 1 hour after waking ( OR 1.93 , 95 % CI 1.27-2 .93 , P < .001 ) compared to smoking within the first 5 minutes after waking .


The findings suggest that the UNED Web-based smoking cessation program was very accessible , but a high level of attrition was confirmed .


This could be related to the ease of enrollment , its free character , and the absence of direct contact with professionals .


It is concluded that , in practice , the greater the accessibility to the program , the lower the adherence and retention .


Professional support from health services and the payment of a reimbursable fee could prevent high rates of attrition .


Stroke volume variation ( SVV ) and pulse pressure variation ( PPV ) , termed dynamic markers of preload responsiveness , may predict the response to i.v. fluid in critically ill patients .


However , the predictive accuracy of these variables during gastrointestinal surgery remains uncertain .


Observational study of patients aged 50 yr undergoing major gastrointestinal surgery , enrolled in the OPTIMISE trial .


Patients received six 250 ml fluid challenges with i.v. colloid solution ( three during and three after surgery ) , while SVV and PPV were measured using the LiDCOrapid monitor ( LiDCO Ltd , UK ) .


Fluid responsiveness was defined as a stroke volume increase 10 % .


Area under the receiver operating characteristic curve was calculated with 95 % confidence intervals .


Adjustment for covariates was performed by regression modelling and a clustering method was used to adjust for intra-patient correlation .


One hundred patients were recruited between August 2010 and October 2012 .


Five hundred and fifty-six fluid challenges were administered and 159 ( 28.6 % ) were associated with increased stroke volume .


The predictive value of both variables was poor during surgery [ SVV 0.69 ( 0.63-0 .77 ) ; PPV 0.70 ( 0.62-0 .77 ) ] , and also after surgery [ SVV 0.69 ( 0.63-0 .78 ) ; PPV 0.64 ( 0.56-0 .73 ) ] .


The findings were similar when analysed according to whether patients were mechanically ventilated [ SVV 0.68 ( 0.63-0 .77 ) ; PPV 0.69 ( 0.61-0 .77 ) ] or breathing spontaneously [ SVV 0.69 ( 0.61-0 .77 ) ; PPV 0.63 ( 0.56-0 .72 ) ] .


Predictive value improved slightly in a sensitivity analysis excluding outlier values of SVV and PPV .


In this study , the predictive accuracy of SVV and PPV for fluid responsiveness was insufficient to recommend for routine clinical use during or after major gastrointestinal surgery .


To report the 6-month comparative outcomes and bleb morphology for needle revision with bevacizumab and mitomycin C ( MMC ) versus MMC alone of failed trabeculectomy and ExPRESS shunt blebs .


Patients undergoing bleb needle revision procedures were enrolled in this study .


All patients received a subconjunctival injection of 0.1 mL MMC ( 0.4 mg/mL ) mixed with 0.1 mL preservative-free lidocaine ( 1 % ) at the beginning of the procedure .


The patients were randomized into 2 cohorts assigned to receive either 1.0 mg ( 0.04 mL of 25 mg/mL ) subconjunctival bevacizumab ( treatment group ) or 0.04 mL of balanced salt solution ( control group ) injected in an identical manner posterior to the bleb after the bleb needling .


Success was defined as 20 % reduction in intraocular pressure ( IOP ) without any IOP-lowering medications .


Qualified success was defined as 20 % reduction of IOP with IOP-lowering medications .


Failure was defined as IOP > 21 mm Hg , IOP reduction < 20 % , or need for additional surgery .


Bleb morphology was classified using the Indiana Bleb Appearance Grading Scale .


Six months postoperatively , in treatment group ( n = 29 ) , 57 % of patients achieved complete success , and 43 % failed .


In control group ( n = 29 ) , 41 % of patients achieved complete success , 7 % achieved qualified success , and 52 % failed .


The difference in success rates between the 2 groups was not statistically significant ( P = 0.35 ) .


At 6 months , the mean IOP was 11.52 in treatment group and 12.83 in control group ( P = 0.45 ) ; patients in treatment group were on a mean of 0.16 medications as compared with 0.58 medications in control group ( P = 0.058 ) .


For bleb morphology of treatment group compared with control group , the blebs had less vascularity ( 0.76 vs. 1.20 , respectively , on a scale of 0 to 4 , P < 0.05 ) and greater extent ( 2.68 vs. 2.36 , on a scale of 0 to 3 , P = 0.022 ) in treatment group .


There was no significant difference between the success rates and IOPs at postoperative month 6 between treatment and control groups .


Postoperative blebs in the treatment group were less vascular and had greater extent .


Venous thromboembolism ( VTE ) is an important complication after major orthopedic surgery .


Pharmaceutical methods represent the main strategy of VTE prevention .


The use of aspirin in VTE prevention is still controversial worldwide , especially in China .


The purpose of this study was to evaluate the role of aspirin combined with mechanical measures in the prevention of VTE after total knee arthroplasty ( TKA ) .


Between January 2012 and May 2013 and in accordance with the inclusion criteria , 120 patients undergoing TKA were randomly allocated to two groups .


To prevent VTE , patients in group A received aspirin combined with mechanical measures postoperatively , while patients in group B received low-molecular-weight heparin ( LMWH ) sodium and rivaroxaban sequentially in combination with mechanical measures postoperatively .


All surgeries were performed by one surgeon using a posterior-stabilized cemented prosthesis .


The two groups were followed up and compared for the incidence of deep vein thrombosis ( DVT ) by duplex ultrasound scan and clinical VTE events .


The adverse events , the blood loss index , and the cost of VTE prevention were also compared .


DVT was detected in 10 of 60 patients in group A ( 16.7 % , 95 % CI : 7.3 % -26.1 % ) compared with 11 of 60 in group B ( 18.3 % , 95 % CI : 8.5 % -27.8 % ) ( P = 0.500 ) .


There is no statistical evidence supporting the inferior effect of aspirin in preventing DVT as compared with the other medications .


There were no cases of symptomatic VTE or death during the follow-up period .


Area of ecchymosis was lower in group A than in group B , and the differences were statistically significant .


Patients in group A had the lower blood loss index as compared with patients in group B. No transfusion cases were found in both groups .


The differences were statistically significant .


The cost of VTE prevention analysis indicated a cost reduction using aspirin in group A compared with using LMWH and rivaroxaban in group B.


Aspirin combined with mechanical measures had a good effect on prevention of VTE after TKA and resulted in lower cost , less blood loss , and less subcutaneous ecchymosis .


Catheter-related infections ( CRIs ) caused by peripheral intravenous catheters ( PIVCs ) are an increasingly common iatrogenic complication .


To prevent this , recommended timelines for routine replacement of PIVCs have increased from 48 h to 72 h and subsequently to 96 h , despite a lack of supporting scientific evidence .


To compare closed-system ( COS ) PIVCs with open-system ( MOS ) PIVCs .


This prospective , randomized controlled trial compared the indwell time of COS PIVCs without complications with that of MOS PIVCs , removed only by clinical indication .


In total , 1199 PIVCs ( 642 inpatients ) were randomized and 283 PIVCs were cultured .


Sixteen catheters ( 11 patients ) were lost to the study after randomization .


In total , 104,469 catheter-hours ( 54,173 h in 584 COS and 50,296 h in 599 MOS ) were recorded .


The median dwell time was 137.1 h for COS PIVCs and 96 h for MOS PIVCs ( P = 0.001 ) .


Among PIVCs in place for 24 h , the median dwell time was 144.5 h for COS PIVCs [ 95 % confidence interval ( CI ) 123.4-165 .6 ] and 99 h for MOS PIVCs ( 95 % CI 87.2-110 .8 ) .


Use of COS PIVCs reduced phlebitis rates by 29 % ( 31 vs 45 cases/1000 catheter-days ; P = 0.004 ) .


The probability that a MOS PIVC would last for 96 h was 79.9 % , and the probability that a COS PIVC would last for 144 h was 80.4 % .


There were no significant differences in rates of bacterial colonization per 1000 catheter-days ( 51.1 COS vs 54.1 MOS ) or CRI ( 5.76 COS vs 6.65 MOS ) .


Nevertheless , there was a 20 % relative risk reduction in CRI .


Use of COS PIVCs reduced episodes of phlebitis and risk of infection at a cost of only 0.09 / day .


When PIVCs are replaced based on clinical indication , COS PIVCs last for up to 144 h and MOS PIVCs last for up to 96 h without increased risk and with significant cost savings ( 786,257 / year/1000 beds ) .


Hypertension is a global health problem .


Multiple classes of drugs including angiotensin receptor blockers ( ARBs ) are available for the treatment of hypertension .


Olmesartan is a relatively newer ARB used in hypertension management .


To assess the efficacy and safety of WIN-BP ( Olmesartan 20mg/40mg ) tablet in Indian patients with hypertension .


An open label , non-comparative , multi-centric , real world post marketing observational study included Indian adult hypertensive patients who were treated with olmesartan 20mg/40mg tablet once daily for six months .


The primary outcome was reduction of systolic blood pressure ( SBP ) to < 140mmHg and diastolic BP ( DBP ) to < 90mmHg at 3 and 6 months after initiation of treatment with olmesartan .


All reported adverse events were recorded .


A total of 8940 patients were enrolled in this study .


Baseline SBP of 164mmHg was reduced to 153 , 145 , 134 and 130mmHg at the end of 15 days , 1 , 3 and 6 months respectively .


Similarly , baseline DBP of 100mmHg was reduced to 93 , 89 , 84 and 82mmHg at the end of 15 days , 1 , 3 and 6 months respectively .


The reduction in both systolic and diastolic blood pressure from day 15 to month 6 was statistically significant ( p < 0.0001 ) with olmesartan treatment .


The percentage of responders for both systolic and diastolic blood pressure increased consistently from day 15 to month 6 .


Only 0.08 % patients reported the adverse events .


No serious adverse event was reported in the study .


Olmesartan 20mg/40mg is effective and well tolerated without any serious adverse events in patients with hypertension .


We suggest an alternative chest compression ( CC ) in kneeling posture using a ` kneeling stool ' on which the performer kneels beside the patient on a bed in-hospital .


In kneeling posture , we can maintain high quality cardiopulmonary resuscitation ( CPR ) without the bed height adjustment , which is necessary and inconvenient in standing posture .


This study is a randomised crossover trial with 38 participants working in one ED .


The first group knelt on the kneeling stool beside a manikin placed on a bed , whereas the second group stood on a step stool with the manikin at knee level using bed height adjustment .


All the participants performed continuous chest compression for 5 min without audio-visual feedback .


After that , the posture was changed in each group .


The parameters of CC quality ( CC depth , rate , accuracy , and incomplete chest recoil ) , visual analogue scale ( VAS ) for fatigue and pain , and preference of participants were compared between the two groups .


The data of 33 participants in both postures were analysed following exclusion of five participants .


In the comparisons overall and per minute between the two postures , the parameters and VAS do not differ significantly ( all P > 0.05 ) except for the median 1st CC rate that was faster in kneeling posture than in standing posture , P = 0.01 ) .


Twenty-three performers preferred the kneeling posture .


A kneeling posture with a kneeling stool were preferred by participants , which have shown similar results in CC parameters and VAS with a standing posture on a stepstool with bed height adjustment during in-hospital CPR .


The purpose of this study was to establish , using a quasi-experimental design , whether 2 family risk factors , parental psychological dysfunction and nonsupportive parenting , during preadolescence could longitudinally predict elevated sympathetic nervous system ( SNS ) activity 9 years later , and to determine whether participation in an efficacious family centered prevention program could moderate these associations if they emerged .


Rural African American preadolescents ( N = 476 ) were assigned randomly to the Strong African American Families ( SAAF ) program or to a control condition .


When youths were 11 years of age ( M = 11.2 years ) , primary caregivers provided data on their own depressive symptoms and self-esteem , and youths provided data on their receipt of nonsupportive parenting .


When the youths were 20 years of age , indicators of SNS activity , the catecholamines epinephrine and norepinephrine , were assayed from their overnight urine voids .


Parental psychological dysfunction and nonsupportive parenting forecast elevated catecholamine levels for youths in the control condition , but not for those in the SAAF condition .


The demonstration that a prevention program can induce reduction of catecholamine levels is important from both theoretical and public health perspectives , because it shows that the developmental progression from family risk factors to heightened sympathetic nervous system activity is not immutable .


The technical performance score ( TPS ) has been reported in a single center study to predict the outcomes after congenital cardiac surgery .


We sought to determine the association of the TPS with outcomes in patients undergoing the Norwood procedure in the Single Ventricle Reconstruction trial .


We calculated the TPS ( class 1 , optimal ; class 2 , adequate ; class 3 , inadequate ) according to the predischarge echocardiograms analyzed in a core laboratory and unplanned reinterventions that occurred before discharge from the Norwood hospitalization .


Multivariable regression examined the association of the TPS with interval to first extubation , Norwood length of stay , death or transplantation , unplanned postdischarge reinterventions , and neurodevelopment at 14 months old .


Of 549 patients undergoing a Norwood procedure , 356 ( 65 % ) had an echocardiogram adequate to assess atrial septal restriction or arch obstruction or an unplanned reintervention , enabling calculation of the TPS .


On multivariable regression , adjusting for preoperative variables , a better TPS was an independent predictor of a shorter interval to first extubation ( P = .019 ) , better transplant-free survival before Norwood discharge ( P < .001 ; odds ratio , 9.1 for inadequate vs optimal ) , shorter hospital length of stay ( P < .001 ) , fewer unplanned reinterventions between Norwood discharge and stage II ( P = .004 ) , and a higher Bayley II psychomotor development index at 14 months ( P = .031 ) .


The TPS was not associated with transplant-free survival after Norwood discharge , unplanned reinterventions after stage II , or the Bayley II mental development index at 14 months .


TPS is an independent predictor of important outcomes after Norwood and could serve as a tool for quality improvement .


Quality improvement is central to improving the care of patients with cardiovascular disease ; however , the optimum type of data feedback to support such efforts is unknown .


Over 26 months , 149 eligible Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines hospitals were randomized to receive either standard ( n = 76 control ) or targeted ( n = 73 intervention ) performance feedback reports for acute myocardial infarction patient care .


Each report summarized performance on identified metrics ( providing hospitals with detailed data on their 3 lowest-performing quality metrics , relative to their peers ) .


Intervention sites received 5 targeted feedback reports .


Overall composite performance was compared between cohorts at end of study and as a change from baseline .


Intervention ( n = 60 ) and control ( n = 64 ) hospitals that completed the study had similar baseline performance ( median score 83.7 % vs 84.2 % ) .


Over 26 months of follow-up , the change in overall composite score across hospitals was neutral ( median 0.1 % [ interquartile range { IQR } -2.4 % to 3.3 % ] ) .


There was no difference in observed improvement in either the intervention ( median -0.2 % [ IQR-2 .6 % to 3.3 % ] ) or control ( median 0.1 % [ IQR -2.2 % to 3.4 % ] ) hospitals .


We were unable to demonstrate that targeted performance feedback reports lead to more rapid care improvements than standard reports .


Future directions should explore the relationship between hospital self-selection of targeted metrics and the identification and promulgation of less common metrics -- particularly those that reflect processes of care .


The use of the incentive spirometer ( IS ) and expiratory positive airway pressure ( EPAP ) provides several benefits in patients with respiratory disorders .


However , the effects of the use of these devices coupled ( IS+EPAP ) are still unknown in asthmatic patients .


The aim of this study was to evaluate the effect of IS associated with EPAP on exercise tolerance ( six-minute walk test - 6MWT ) , lung function ( by spirometry ) , asthma control ( Asthma Control Questionnaire - ACQ ) and quality of life ( Asthma Quality of Life Questionnaire - AQLQ ) in patients with severe asthma .


Patients were randomised into two groups : IS+EPAP ( n = 8 ) and control ( n = 6 ) .


The IS+EPAP group performed breathing exercises at home , twice daily for 20min , over a period of 5 weeks .


There was no significant difference in spirometric variables and in the distance walked in the 6MWT in both groups .


However , the IS+EPAP group showed an improvement in asthma control ( p = 0.002 ) and quality of life ( p = 0.02 ) .


These findings demonstrate that the IS+EPAP protocol , when performed at home , provides an improvement in asthma control and quality of life for patients with severe asthma when evaluated by ACQ and AQLQ , respectively .


The aim of this study was to test the effect different unstable footwear constructions have on centre of pressure motion when standing .


Sixteen young female volunteers were tested in five conditions , three unstable footwear ( Reebok Easy-Tone , FitFlop and Skechers Shape-Ups ) , a standard shoe and barefoot in a randomised order .


Double and single leg balance on a force plate was assessed via centre of pressure excursions and displacements in each condition .


For double leg and single leg standing centre of pressure excursions in the anterior-posterior direction were significantly increased wearing Skechers Shape-Ups compared to barefoot and the standard shoe .


For the Reebok Easy Tone during single leg standing excursions in the anterior-posterior direction were significantly greater compared to the barefoot condition .


Cumulative displacement of the centre of pressure in medial-lateral direction increased significantly during single leg standing when wearing Skechers Shape-Ups compared to barefoot and standard shoe as well as for Reebok Easy Tone vs. barefoot .


It would appear from these quiet standing results that the manner of the construction of instability shoes effects the CoP movement which is associated with induced instability .


Greater CoP excursion occurred in the A-P direction while the cumulative displacements were greater in the M-L direction for those shoes with the rounded sole and soft foam and those with airpods .


The shoe construction with altered density foam did not induce any change in the CoP movement , during quite standing , which tends to suggest that it is not effective at inducing balance .


Not all instability shoes are effective in altering the overall instability of the wearer .


To observe the clinical effect of cupping combined with acupuncture stimulation of trigger points on lumbar myofascial pain syndrome ( MPS ) .


Sixty MPS patients were randomly divided into acupuncture + TDP group ( n = 30 ) , and cupping + acupuncture group ( n = 30 ) .


Patients in the acupuncture + TDP group were treated by acupuncture stimulation of trigger points and local TDP irradiation , and patients of the cupping + acupuncture group treated by intensive cupping applied to the myofascial band and acupuncture stimulation of the locus according to the position of muscular tension band .


The therapeutic effects were assessed according to the score of the McGill pain questionnaire composing of pain rating index ( PRI ) , visual analogue scale ( VAS ) and present pain intensity ( PPI ) before , immediately and 1 month after the treatment .


After the treatment , the total effective rates of the acupuncture + TDP and cupping + acupuncture groups were 83.3 % ( 25/30 ) and 96.6 % ( 29/30 ) , respectively , without significant difference between the two groups ( P > 0.05 ) .


One month 's follow-up showed that the total effective rates of the acupuncture + TDP and cupping + acupuncture groups were 40.0 % and 90.0 % respectively , and the latter group was significantly better than the acupuncture + TDP group in the therapeutic effect ( P < 0.05 ) .


The scores of PRI , VAS , PPI after the treatment were markedly decreased in both groups ( P < 0.05 ) .


One month later , the scores of PRI , VAS and PPI in the cupping + acupuncture group were obviously lower than those of the acupuncture group ( P < 0.05 ) .


Both acupuncture stimulation of trigger points plus TDP and cupping plus acupuncture can effectively relieve pain in MPS patients , while the therapeutic effect of cupping plus acupuncture treatment lasts longer analgesic effect .


The efficacy of cognitive behavioral therapy for insomnia ( CBT-I ) has been suggested for insomnia concomitant with depression , but its impact on quality of life ( QoL ) has not been adequately evaluated .


The study aimed to determine which aspects of QoL could be affected by CBT-I and how any changes in QoL were mediated by changes in insomnia and depression .


We conducted a 4-week randomized controlled trial with 4-week follow-up in outpatient clinics in Japan .


Thirty-seven patients with DSM-IV diagnosis of major depressive disorder concomitant with chronic insomnia were randomly assigned to the treatment-as-usual ( TAU ) alone arm or the TAU with brief behavioral therapy for insomnia ( TAU plus psychotherapy ) arm using modified CBT-I consisting of 4 weekly individual sessions .


We evaluated QoL using norm-based scoring of the Short Form-36 at baseline and at 8 weeks .


We also examined associations between QoL subscales and remission in insomnia or depression while controlling for baseline scores of the entire sample .


We tested group effects while controlling for baseline scores .


TAU plus psychotherapy resulted in significantly better scores on physical functioning ( p = 0.006 ) , social functioning ( p = 0.002 ) , and mental health ( p = 0.041 ) subscales than TAU alone at 8 weeks .


Patients with either remitted insomnia or depression showed higher QoL scores than non-remitted patients ; scores approximated those within the normal range .


For patients with insomnia in depression , adding CBT-I to TAU can produce substantive benefits in some aspects of QoL .


ClinicalTrials.gov Identifier : NCT00610259 , http://www.clinicaltrials.gov/ .


The feasibility of an interventional clinical trial in idiopathic pulmonary fibrosis ( IPF ) using death and hospitalization as primary end points is an area of uncertainty .


Using data from a large well-characterized clinical trial population , this article aims to illustrate the impact of cohort enrichment and study duration on sample size requirements for IPF clinical trials in which death alone or death plus hospitalization serve as the primary end point .


Event rate estimates for death and hospitalization were determined from patients enrolled in National Institutes of Health-sponsored IPF Clinical Research Network clinical trials .


Standard equations were applied to estimate the total sample size required for varying gender , age , and pulmonary function ( GAP ) stage-based cohorts .


Risk estimates for death and hospitalization in the clinical trial cohort were substantially lower than those published .


An IPF trial with death as its primary end point enrolling subjects designated as GAP stage 1 and 2 over 1 year with a minimum follow-up of 1 year would require an estimated 7,986 subjects to achieve 90 % power for a hazard ratio of 0.70 .


Alternatively , an IPF trial with death plus hospitalization as its primary end point enrolling subjects with GAP stage 2 and 3 over 2 years with a minimum follow-up of 1 year would require an estimated 794 subjects for the same power and hazard ratio .


Study design decisions , in particular cohort enrichment strategies , have a substantial impact on sample size requirements for IPF clinical trials using time-to-event primary end points such as death and death plus hospitalization .


Epidermal growth factor ( EGF ) is an important growth factor in regulation of cell proliferation , differentiation , survival and apoptosis .


Studies showed that food-grade Lactococcus lactis ( L. lactis ) and NICE expression system have superior performance in exogenous protein expression .


This study aimed to construct and express porcine EGF ( pEGF ) , and use L. lactis as vehicle for producing and delivering pEGF .


Furthermore , investigating biological activity of pEGF and exploring applications feasibility of combination effects of L. lactis and pEGF on early weaned piglets ' production .


A recombinant Lactococcus lactis which produced and secreted pEGF at 1000 ng/ml in culture supernatant was generated .


Secreted pEGF was a fully biologically active protein , as demonstrated by its capacity to stimulate L929 mouse fibroblast cell line proliferation in vitro .


For in vivo study , forty piglets were randomly allocated to control , antibiotic control , empty vector-expressing L. lactis ( LL-EV ) and pEGF-secreting L. lactis ( LL-pEGF ) .


After 14 d of rearing , final body weight and average daily gain in LL-pEGF were greater ( P < 0.05 , 8.95 vs. 8.37 kg , 206.1 vs. 157.7 g/day , respectively ) than those in control , but no significant differences between LL-pEGF , LL-EV and antibiotic control .


Overall period average daily feed intake was higher in LL-pEGF , LL-EV and antibiotic control than in control ( P < 0.05 , 252.9 , 255.6 , 250.0 , 207.3 g/day , respectively ) .


No significant difference was observed on ADFI/ADG .


LL-pEGF increased villous height in the duodenum , jejunum and ileum than in control and LL-EV ( P < 0.05 ) .


Sucrase in the 3 intestinal segments , aminopeptidase A in the duodenum and Jejunum , aminopeptidase N and dipeptidase IV in the duodenum in LL-pEGF were higher than those in control ( P < 0.05 ) .


Furthermore , Escherichia coli and Enterococcus counts decreased in the ileum and Lactobacillus increased in the ileum and cecum digesta in LL-pEGF compare with the control ( P < 0.05 ) .


Lactobacillus increased in the cecum in LL-EV compared with control and antibiotic control ( P < 0.05 ) .


We have generated a recombinant Lactococcus lactis which produced and secreted fully biologically active porcine EGF .


Oral administration of pEGF-secreting L. lactis had beneficial effects on intestinal health and performance of early-weaned piglets .


Sequence-dependent improved efficacy of topoisomerase I followed by topoisomerase 2 inhibitors was assessed in a randomized phase II study in extensive-stage small-cell lung cancer ( SCLC ) .


Patients with previously untreated extensive-stage SCLC with measurable disease , ECOG performance status of 0-3 and stable brain metastases were eligible .


Arm A consisted of topotecan ( 0.75 mg/m ( 2 ) ) on days 1 , 2 and 3 , etoposide ( 70 mg/m ( 2 ) ) and cisplatin ( 20 mg/m ( 2 ) ) ( PET ) on days 8 , 9 and 10 in a 3-week cycle .


Arm B consisted of irinotecan ( 50 mg/m ( 2 ) ) and cisplatin ( 20 mg/m ( 2 ) ) on days 1 and 8 followed by etoposide ( 85 mg/m ( 2 ) PO bid ) on days 3 and 10 ( PIE ) in a 3-week cycle .


We enrolled 140 patients and randomized 66 eligible patients to each arm .


Only 54.5 % of all patients completed the planned maximum 6 cycles .


There were grade 3 treatment-related adverse events in approximately 70 % of the patients on both arms including 6 treatment-related grade 5 events .


The overall response rates ( CR + PR ) were 69.7 % ( 90 % CI 59.1-78 .9 , 95 % CI 57.1-80 .4 % ) for arm A and 57.6 % ( 90 % CI 46.7-67 .9 , 95 % CI 44.8-69 .7 % ) for arm B.


The median progression-free survival and overall survival were 6.4 months ( 95 % CI 5.4-7 .5 months ) and 11.9 months ( 95 % CI 9.6-13 .7 months ) for arm A and 6.0 months ( 95 % CI 5.4-7 .0 months ) and 11.0 months ( 95 % CI 8.6-13 .1 months ) for arm B.


Sequential administration of topoisomerase inhibitors did not improve on the historical efficacy of standard platinum-doublet chemotherapy for extensive-stage SCLC .


Atrial fibrillation is associated with inflammation and oxidative stress .


Carvedilol and N-acetyl cysteine ( NAC ) combination decreases inflammation , oxidative stress , and postoperative atrial fibrillation ( POAF ) rates more than metoprolol or carvedilol .


Preoperative and postoperative total oxidative stress ( TOS ) , total antioxidant capacity ( TAC ) , and white blood cells ( WBC ) were measured in metoprolol , carvedilol , or carvedilol plus NAC groups , and association with POAF was evaluated .


Preoperative TAC , TOS , and WBC levels were similar among the groups .


Postoperative TAC levels were lower in the metoprolol group compared with the carvedilol group ( 1.0 vs 1.4 ) or the carvedilol plus NAC group ( 1.0 vs 1.9 ) and were also lower in the carvedilol group compared with the carvedilol plus NAC group ( all P < 0.0001 ) .


Postoperative TOS levels were higher in the metoprolol group as compared with the carvedilol ( 29.6 vs 24.2 ; P < 0.0001 ) or the carvedilol plus NAC groups ( P < 0.0001 ) , and were also higher in the carvedilol group as compared with the carvedilol plus NAC group ( 24.2 vs 19.3 ; P < 0.0001 ) .


Postoperative WBC counts were lower in the carvedilol plus NAC group compared with the metoprolol group ( 12.9 vs 14.8 ; P = 0.004 ) , were similar between the carvedilol and the metoprolol groups ( 13 vs 14.8 ) and between the carvedilol plus NAC group and the carvedilol group ( both P > 0.05 ) .


Postoperative TAC , TOS , and WBC were associated with POAF .


Carvedilol plus NAC reduced oxidative stress and inflammation compared with metoprolol and decreased oxidative stress compared with carvedilol .


The issue on timing and number of bile sampling for exfoliative bile cytology is still unsettled .


A total of 100 patients with cholangiocarcinoma undergoing resection after external biliary drainage were randomized into two groups : a 2-day group where bile was sampled five times per day for 2 days ; and a 10-day group where bile was sampled once per day for 10 days ( registered University Hospital Medical Information Network/ID 000005983 ) .


The outcome of 87 patients who underwent laparotomy was analyzed , 44 in the 2-day group and 43 in the 10-day group .


There were no significant differences in patient characteristics between the two groups .


Positivity after one sampling session was significantly lower in the 2-day group than in the 10-day group ( 17.0 3.7 % vs. 20.7 3.5 % , P = 0.034 ) .


However , cumulative positivity curves were similar and overlapped each other between both groups .


The final cumulative positivity by the 10th sampling session was 52.3 % in the 2-day group and 51.2 % in the 10-day group .


We observed a small increase in cumulative positivity after the 5th or 6th session in both groups .


Bile cytology positivity is unlikely to be affected by sample time .


To identify nasal width changes occurring after Le Fort I osteotomy and to compare prospectively the effect of three surgical techniques for controlling postoperative nasal width .


In the study , 79 patients ( 22 male and 57 female , mean age 23.2 3.4 years ) , who received Le Fort I osteotomy at Peking University Hospital of Stomatology from 2011 to 2014 , were randomly divided into three groups .


Group 1 was treated with traditional intraoral alar base cinch suture ( ABCS ) ; Group 2 with extraoral ABCS , and Group 3 with traditional ABCS plus an extra intraoral suture at points G.lat .


All the patients had taken 3D photos using 3dMD camera before operation , and 3 , and 6 months after operation .


The nasal widths , which were indicated as distances between Sbal-Sbal , G.lat-G .


lat and Al-Al , were measured by two examiners in the 3D photos three times with a time-interval of one week .


SPSS 13.0 was used to do the statistic analysis .


At the end of the postoperative 6 months , the nasal widths lessened as compared with the postoperative 3 months .


No significant differences were found between the three groups 6 months after the operation .


The degree of the postoperative nasal width widening had positive correlation with that of the intraoperative nasal width widening , and had negative correlation with the initial nasal width and the amount of post-suture narrowing .


There is no difference between three suturing techniques for controlling nasal width widening after Le Fort I osteotomy .


The postoperative nasal width-widening ca n't be totally avoided , and the alteration might last at least 6 months after the operation .


For patients with narrow nasal width and need to move maxilla forward , more overcorrection of ABCS is needed to control the postoperative nasal base widening .


To examine physical activity ( PA ) thresholds affecting glucose , insulin and lipid concentrations and body fat composition in high-risk patients for type 2 diabetes ( T2D ) .


A total of 113 subjects of both genders having abnormal glucose levels in the oral glucose tolerance test were contacted .


A total of 78 subjects with age 58.810.4 years and body mass index 31.75.3 kgm ( -2 ) were randomly assigned to intervention and control groups .


INTERVENTION consisted of a supervised walking ( 60min three times weekly ) for 3 months .


All the subjects received standard care for PA and weight reduction and wore an accelerometer during the whole wakeful time .


Over 80 % of the daily steps clustered at an acceleration level of 0.3-0 .7 g ( 2-3kmh ( -1 ) of walking ) and were 5870 in the intervention and 4434 in the control group ( P < 0.029 ) .


Between 0 and 3 months no significant changes were observed in fasting and 2-h glucose , body weight or maximal oxygen uptake .