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-###24290286
-BACKGROUND	IgE sensitization to Aspergillus fumigatus and a positive sputum fungal culture result are common in patients with refractory asthma .
-BACKGROUND	It is not clear whether these patients would benefit from antifungal treatment .
-OBJECTIVE	We sought to determine whether a 3-month course of voriconazole improved asthma-related outcomes in patients with asthma who are IgE sensitized to A fumigatus .
-METHODS	Asthmatic patients who were IgE sensitized to A fumigatus with a history of at least 2 severe exacerbations in the previous 12 months were treated for 3 months with 200 mg of voriconazole twice daily , followed by observation for 9 months , in a double-blind , placebo-controlled , randomized design .
-METHODS	Primary outcomes were improvement in quality of life at the end of the treatment period and a reduction in the number of severe exacerbations over the 12 months of the study .
-RESULTS	Sixty-five patients were randomized .
-RESULTS	Fifty-nine patients started treatment ( 32 receiving voriconazole and 27 receiving placebo ) and were included in an intention-to-treat analysis .
-RESULTS	Fifty-six patients took the full 3 months of medication .
-RESULTS	Between the voriconazole and placebo groups , there were no significant differences in the number of severe exacerbations ( 1.16 vs 1.41 per patient per year , respectively ; mean difference , 0.25 ; 95 % CI , 0.19-0 .31 ) , quality of life ( change in Asthma Quality of Life Questionnaire score , 0.68 vs 0.88 ; mean difference between groups , 0.2 ; 95 % CI , -0.05 to -0.11 ) , or any of our secondary outcome measures .
-CONCLUSIONS	We were unable to show a beneficial effect of 3 months of treatment with voriconazole in patients with moderate-to-severe asthma who were IgE sensitized to A fumigatus on either the rate of severe exacerbations , quality of life , or other markers of asthma control .
-
-###24464531
-BACKGROUND	Opioid antagonists ( e.g. , naltrexone ) and positive modulators of - aminobutyric-acidA ( GABAA ) receptors ( e.g. , alprazolam ) modestly attenuate the abuse-related effects of stimulants like amphetamine .
-BACKGROUND	The use of higher doses to achieve greater efficacy is precluded by side effects .
-BACKGROUND	Combining naltrexone and alprazolam might safely maximize efficacy while avoiding the untoward effects of the constituent compounds .
-OBJECTIVE	The present pilot study tested the hypothesis that acute pretreatment with the combination of naltrexone and alprazolam would not produce clinically problematic physiological effects or negative subjective effects and would reduce the positive subjective effects of d-amphetamine to a greater extent than the constituent drugs alone .
-METHODS	Eight nontreatment-seeking , stimulant-using individuals completed an outpatient experiment in which oral d-amphetamine ( 0 , 15 , and 30 mg ) was administered following acute pretreatment with naltrexone ( 0 and 50 mg ) and alprazolam ( 0 and 0.5 mg ) .
-METHODS	Subjective effects , psychomotor task performance , and physiological measures were collected .
-RESULTS	Oral d-amphetamine produced prototypical physiological and stimulant-like positive subjective effects ( e.g. , VAS ratings of Active/Alert/Energetic , Good Effect , and High ) .
-RESULTS	Pretreatment with naltrexone , alprazolam , and their combination did not produce clinically problematic acute physiological effects or negative subjective effects .
-RESULTS	Naltrexone and alprazolam each significantly attenuated some of the subjective effects of d-amphetamine .
-RESULTS	The combination attenuated a greater number of subjective effects than the constituent drugs alone .
-CONCLUSIONS	The present results support the continued evaluation of an opioid receptor antagonist combined with a GABAA-positive modulator using more clinically relevant experimental conditions like examining the effect of chronic dosing with these drugs on methamphetamine self-administration .
-
-###24494594
-BACKGROUND	The sequencing of learning materials greatly influences the knowledge that learners construct .
-BACKGROUND	Recently , learning theorists have focused on the sequencing of instruction in relation to solving related problems .
-BACKGROUND	The general consensus suggests explicit instruction should be provided ; however , when to provide instruction remains unclear .
-OBJECTIVE	We tested the impact of conceptual instruction preceding or following mathematics problem solving to determine when conceptual instruction should or should not be delayed .
-OBJECTIVE	We also examined the learning processes supported to inform theories of learning more broadly .
-METHODS	We worked with 122 second - and third-grade children .
-METHODS	In a randomized experiment , children received instruction on the concept of math equivalence either before or after being asked to solve and explain challenging equivalence problems with feedback .
-RESULTS	Providing conceptual instruction first resulted in greater procedural knowledge and conceptual knowledge of equation structures than delaying instruction until after problem solving .
-RESULTS	Prior conceptual instruction enhanced problem solving by increasing the quality of explanations and attempted procedures .
-CONCLUSIONS	Providing conceptual instruction prior to problem solving was the more effective sequencing of activities than the reverse .
-CONCLUSIONS	We compare these results with previous , contrasting findings to outline a potential framework for understanding when instruction should or should not be delayed .
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-###25585595
-BACKGROUND	Patient adherence to appointments is key to improving outcomes in health care .
-BACKGROUND	`` No-show '' appointments contribute to suboptimal resource use .
-BACKGROUND	Patient navigation and telephone reminders have been shown to improve cancer care and adherence , particularly in disadvantaged populations , but may not be cost-effective if not targeted at the appropriate patients .
-METHODS	In 5 clinics within a large academic cancer center , patients who were considered to be likely ( the top 20th percentile ) to miss a scheduled appointment without contacting the clinic ahead of time ( `` no-shows '' ) were identified using a predictive model and then randomized to an intervention versus a usual-care group .
-METHODS	The intervention group received telephone calls from a bilingual patient navigator 7 days before and 1 day before the appointment .
-RESULTS	Over a 5-month period , of the 40,075 appointments scheduled , 4425 patient appointments were deemed to be at high risk of a `` no-show '' event .
-RESULTS	After the patient navigation intervention , the no-show rate in the intervention group was 10.2 % ( 167 of 1631 ) , compared with 17.5 % in the control group ( 280 of 1603 ) ( P < .001 ) .
-RESULTS	Reaching a patient or family member was associated with a significantly lower no-show rate ( 5.9 % and 3.0 % , respectively ; P < .001 and .006 , respectively ) compared with leaving a message ( 14.7 % : P = .117 ) or no contact ( no-show rate , 21.6 % : P = .857 ) .
-CONCLUSIONS	Telephone navigation targeted at those patients predicted to be at high risk of visit nonadherence was found to effectively and substantially improve patient adherence to cancer clinic appointments .
-CONCLUSIONS	Further studies are needed to determine the long-term impact on patient outcomes , but short-term gains in the optimization of resources can be recognized immediately .
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-###25344483
-BACKGROUND	Insufficient skills in drug dose calculations increase the risk for medication errors .
-BACKGROUND	Even experienced nurses may struggle with such calculations .
-BACKGROUND	Learning flexibility and cost considerations make e-learning interesting as an alternative to classroom teaching .
-BACKGROUND	This study compared the learning outcome and risk of error after a course in drug dose calculations for nurses with the two methods .
-METHODS	In a randomised controlled open study , nurses from hospitals and primary healthcare were randomised to either e-learning or classroom teaching .
-METHODS	Before and after a 2-day course , the nurses underwent a multiple choice test in drug dose calculations : 14 tasks with four alternative answers ( score 0-14 ) , and a statement regarding the certainty of each answer ( score 0-3 ) .
-METHODS	High risk of error was being certain that incorrect answer was correct .
-METHODS	The results are given as the mean ( SD ) .
-RESULTS	16 men and 167 women participated in the study , aged 42.0 ( 9.5 ) years with a working experience of 12.3 ( 9.5 ) years .
-RESULTS	The number of correct answers after e-learning was 11.6 ( 2.0 ) and after classroom teaching 11.9 ( 2.0 ) ( p = 0.18 , NS ) ; improvement were 0.5 ( 1.6 ) and 0.9 ( 2.2 ) , respectively ( p = 0.07 , NS ) .
-RESULTS	Classroom learning was significantly superior to e-learning among participants with a pretest score below 9 .
-RESULTS	In support of e-learning was evaluation of specific value for the working situation .
-RESULTS	There was no difference in risk of error between groups after the course ( p = 0.77 ) .
-CONCLUSIONS	The study showed no differences in learning outcome or risk of error between e-learning and classroom teaching in drug dose calculations .
-CONCLUSIONS	The overall learning outcome was small .
-CONCLUSIONS	Weak precourse knowledge was associated with better outcome after classroom teaching .
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-###24917452
-BACKGROUND	Previous investigation showed that the volume-time curve technique could be an alternative for endotracheal tube ( ETT ) cuff management .
-BACKGROUND	However , the clinical impact of the volume-time curve application has not been documented .
-BACKGROUND	The purpose of this study was to compare the occurrence and intensity of a sore throat , cough , thoracic pain , and pulmonary function between these 2 techniques for ETT cuff management : volume-time curve technique versus minimal occlusive volume ( MOV ) technique after coronary artery bypass grafting .
-METHODS	A total of 450 subjects were randomized into 2 groups for cuff management after intubation : MOV group ( n = 222 ) and volume-time curve group ( n = 228 ) .
-METHODS	We measured cuff pressure before extubation .
-METHODS	We performed spirometry 24 h before and after surgery .
-METHODS	We graded sore throat and cough according to a 4-point scale at 1 , 24 , 72 , and 120 h after extubation and assessed thoracic pain at 24 h after extubation and quantified the level of pain by a 10-point scale .
-RESULTS	The volume-time curve group presented significantly lower cuff pressure ( 30.9 2.8 vs 37.7 3.4 cm H2O ) , less incidence and intensity of sore throat ( 1 h , 23.7 vs 51.4 % ; and 24 h , 18.9 vs 40.5 % , P < .001 ) , cough ( 1 h , 19.3 vs 48.6 % ; and 24 h , 18.4 vs 42.3 % , P < .001 ) , thoracic pain ( 5.2 1.8 vs 7.1 1.7 ) , better preservation of FVC ( 49.5 9.9 vs 41.8 12.9 % , P = .005 ) , and FEV1 ( 46.6 1.8 vs 38.6 1.4 % , P = .005 ) compared with the MOV group .
-CONCLUSIONS	The subjects who received the volume-time curve technique for ETT cuff management presented a significantly lower incidence and severity of sore throat and cough , less thoracic pain , and minimally impaired pulmonary function than those subjects who received the MOV technique during the first 24 h after coronary artery bypass grafting .
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-###25376617
-OBJECTIVE	To investigate safety and evidence of efficacy of IBI-20089 , an intravitreal , liquid , sustained drug delivery system formulated with triamcinolone acetonide ( TA ) in combination with ranibizumab ( Lucentis ) for neovascular age related macular degeneration .
-METHODS	Patients received a single intravitreal injection of IBI-20089 containing either 6.9 mg ( 25L ) TA or 13.8 mg ( 50L ) TA followed a week later by intravitreal injection of 0.5 mg ranibizumab .
-METHODS	Patients were followed monthly and underwent best corrected visual acuity testing , slit lamp biomicroscopy , dilated ophthalmoscopy , fundus photos and optical coherence tomography .
-METHODS	Patients received pro re nata dosing of ranibizumab .
-RESULTS	Patients ranged in age from 59 years to 81years ( mean 73.4 years ) and all completed 1year follow-up .
-RESULTS	No serious related adverse events occurred .
-RESULTS	Ocular adverse events included mild , transient , elevated intraocular pressure in eight patients and cataract progression in three of the five phakic patients .
-RESULTS	At 1year , 30 of a total 120 ( 25 % ) possible pro re nata re-Rx 's had been given .
-RESULTS	Combination therapy resulted in a median number of 3.5 re-treatments at and including month 12 .
-CONCLUSIONS	Combination therapy IBI-20089 and ranibizumab was well-tolerated and resulted in fewer ranibizumab retreatments .
-CONCLUSIONS	Transient intraocular pressure elevation and cataract progression occurred .
-BACKGROUND	NCT01175395 .
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-###25710288
-OBJECTIVE	To estimate age at attaining Tanner stages in Ugandan/Zimbabwean HIV-infected children initiating antiretroviral therapy ( ART ) in older childhood and investigate predictors of delayed puberty , particularly age at ART initiation .
-METHODS	Observational analysis within a randomized trial .
-METHODS	Tanner staging was assessed every 24 weeks from 10 years of age , menarche every 12 weeks and height every 4-6 weeks .
-METHODS	Age at attaining different Tanner stages was estimated using normal interval regression , considering predictors using multivariable regression .
-METHODS	Growth was estimated using multilevel models with child-specific intercepts and trajectories .
-RESULTS	Median age at ART initiation was 9.4 years ( inter-quartile range 7.8 , 11.3 ) ( n = 582 ) .
-RESULTS	At the first assessment , the majority ( 80.2 % ) were in Tanner stage 1 ; median follow-up with staging was 2.8 years .
-RESULTS	There was a strong delaying effect of older age at ART initiation on age at attaining all Tanner stages ( P < 0.05 ) and menarche ( P = 0.02 ) ; in boys the delaying effect generally weakened with older age .
-RESULTS	There were additional significant delays associated with greater impairments in pre-ART height-for-age Z-score ( P < 0.05 ) in both sexes and pre-ART BMI-for-age in girls ( P < 0.05 ) .
-RESULTS	There was no evidence that pre-ART immuno-suppression independently delayed puberty or menarche .
-RESULTS	However , older children/adolescents had significant growth spurts in intermediate Tanner stages , and were still significantly increasing their height when in Tanner stage 5 ( P < 0.01 ) .
-CONCLUSIONS	Delaying ART initiation until older childhood substantially delays pubertal development and menarche , independently of immuno-suppression .
-CONCLUSIONS	This highlights that factors other than CD4 , such as pubertal development , need consideration when making decisions about timing of ART initiation in older children .
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-###25255799
-OBJECTIVE	To assess the effects of a patient oriented decision aid for prioritising treatment goals in diabetes compared with usual care on patient empowerment and treatment decisions .
-METHODS	Pragmatic randomised controlled trial .
-METHODS	18 general practices in the north of the Netherlands .
-METHODS	344 patients with type 2 diabetes aged 65 years at the time of diagnosis and managed in primary care between April 2011 and August 2012 : 225 were allocated to the intervention group and 119 to the usual care group .
-METHODS	The intervention comprised a decision aid for people with diabetes , with individually tailored risk information and treatment options for multiple risk factors .
-METHODS	The aid was intended to empower patients to prioritise between clinical domains and to support treatment decisions .
-METHODS	It was offered to participants before a regular diabetes check-up and to their healthcare provider during the consultation .
-METHODS	Four different formats of the decision aid were included for additional explorative analyses .
-METHODS	The primary outcome was the effects on patient empowerment for setting and achieving goals .
-METHODS	The secondary outcomes were changes in the prescribing of drugs to regulate glucose , blood pressure , lipids , and albuminuria .
-METHODS	Data were collected through structured questionnaires and automated data extraction from electronic health records during six months before and after the intervention .
-RESULTS	Of all intervention participants , 103 ( 46 % ) reported to have received the basic elements of the intervention .
-RESULTS	For the primary outcome analysis , 199 intervention and 107 control patients with sufficient baseline and follow-up data could be included .
-RESULTS	The mean empowerment score increased 0.1 on a 5 point scale in the overall intervention group , which was not significantly different from that of the control group ( mean difference after adjusting for baseline 0.039 , 95 % confidence interval -0.056 to 0.134 ) .
-RESULTS	Lipid regulating drug treatment was intensified in 25 % of intervention and 12 % of control participants with increased cholesterol levels , which did not reach significance when the intervention was compared with the usual care group ( odds ratio 2.54 , 95 % confidence interval 0.89 to 7.23 ) .
-RESULTS	Prespecified explorative analyses showed that this effect was significant for the printed version of the decision aid in comparison to usual care ( 3.90 , 1.29 to 11.80 ) .
-RESULTS	No relevant or significant changes were seen for other treatments .
-CONCLUSIONS	We found no evidence that the patient oriented treatment decision aid improves patient empowerment by an important amount .
-CONCLUSIONS	The aid was not used to its full extent in a substantial number of participants .
-BACKGROUND	Dutch trial register NTR1942 .
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-###26048455
-BACKGROUND	Bicalutamide blocks androgen action and is frequently used in men with non-metastatic , castration-resistant prostate cancer ( CRPC ) .
-BACKGROUND	By reducing intracellular dihydrotestosterone , dutasteride ( dual 5-alpha reductase inhibitor ) could increase the effectiveness of bicalutamide in this setting .
-BACKGROUND	The objective of the study is therefore to prospectively evaluate dutasteride plus bicalutamide in men with asymptomatic , non-metastatic CRPC with rising prostate-specific antigen ( PSA ) .
-METHODS	Prostate cancer patients with rising PSA whilst on first-line androgen deprivation therapy ( ADT ) were randomised ( 1:1 ) in a double-blind trial to receive bicalutamide 50mg plus placebo or bicalutamide 50mg plus dutasteride 3.5 mg once daily for 18 months .
-METHODS	Randomisation was stratified by centre ; treatment assignments were generated using GlaxoSmithKline 's RandAll System .
-METHODS	Subjects who completed 18 months could participate in the 2-year extension .
-METHODS	Central laboratory and study sites/monitors remained treatment-blinded .
-METHODS	Primary end-point was time to disease progression ( TDP ) up to 42 months ( defined as PSA progression from baseline or nadir , radiographic disease progression , death from prostate cancer or receipt of rescue medication ) .
-RESULTS	There was no statistically significant difference in TDP in 127 men treated with bicalutamide/dutasteride ( n = 62 ) compared with bicalutamide/placebo ( n = 65 ) ( hazard ratio ( HR ) = 0.94 [ 95 % confidence interval ( CI ) 0.61 , 1.46 ] ; p = 0.79 ) .
-RESULTS	The estimated median TDP was 425 days ( 95 % CI 302 , 858 ) in the bicalutamide/placebo group and 623 days ( 95 % CI 369 , 730 ) in the bicalutamide/dutasteride group .
-RESULTS	There was no statistically significant difference between the treatment groups for any secondary efficacy end-points , including time to treatment failure or PSA response .
-RESULTS	In the multivariate analysis , age , non-White race , higher baseline testosterone and lower baseline PSA were associated with longer TDP .
-RESULTS	Adverse events were comparable between treatment groups .
-CONCLUSIONS	In men with non-metastatic CRPC , adding dutasteride to bicalutamide did not significantly prolong TDP .
-CONCLUSIONS	Prospective data are provided concerning the common practice of using bicalutamide in this setting .
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-###25422589
-BACKGROUND	Menopause is the stage when the menstrual period permanently stops , and is a part of every woman 's life .
-BACKGROUND	It usually occurs between the ages of 40 and 60 years , and is associated with hormonal , physical , and psychological changes .
-BACKGROUND	Estrogen and progesterone levels play the biggest part in menopause .
-BACKGROUND	In this stage , the ovaries make less estrogen and progesterone .
-BACKGROUND	When the body produces less of these hormones , the parts of the body that depend on estrogen to keep them healthy will react and this often causes discomfort for women .
-BACKGROUND	This study tested the impact of a complementary health approach to quality of life in menopausal women .
-METHODS	A community-based interventional study was conducted in selected areas in Kattankulathur Block , Kanchipuram District , Tamil Nadu , India .
-METHODS	A simple random sampling technique was used to select menopausal women for the study .
-METHODS	Of 260 menopausal women identified , 130 were allocated to a study group and 130 to a control group .
-METHODS	The study group underwent yoga training for 1.5 hours per day on 5 consecutive days .
-METHODS	After the 5-day intensive yoga training program , the menopausal women practiced yoga daily at home for 35-40 minutes a day .
-METHODS	Along with daily yoga practice , they underwent group yoga practice for 2 days a week under the supervision of one of the investigators until 18 weeks .
-METHODS	The yoga training program consisted of Yogasanas , Pranayama ( breathing exercises ) , and meditation .
-METHODS	The standardized World Health Organization QoL BREF scale was used to assess the women 's quality of life .
-METHODS	We distributed an instruction manual on steps of selected yoga practice for the women 's self-reference at home after the 5 days of continuous yoga practice .
-METHODS	A yoga practice diary was used to confirm regular performance of yoga .
-METHODS	The women in the control group did not participate in the yoga program ; however , on completion of the study , these women received intensive yoga training for 5 days .
-RESULTS	There was an extremely high statistically significant difference ( P = 0.001 ) between the study group and the control group with regard to the physical , psychological , social , and environmental domains of quality of life after 6 , 12 , and 18 weeks of yoga therapy .
-RESULTS	The mean gain score was high in all the domains of quality of life in the study group at weeks 6 , 12 , and 18 .
-RESULTS	The overall mean gain score in the study group was 31.58 versus 1.61 in the control group .
-RESULTS	The overall mean gain score difference was 29.97 in all domains of quality of life between the study group and the control group .
-RESULTS	In the study group , the physical , psychological , social , and environmental domains of quality of life were greatly improved by practicing yoga for 18 weeks .
-RESULTS	No adverse events were reported by the women after yoga practice .
-CONCLUSIONS	Quality of life in menopausal women was greatly improved after 18 weeks of yoga practice .
-CONCLUSIONS	Women who regularly practice yoga find that they are able to enjoy menopause and experience the freedom , liberation , and energy that it brings .
-CONCLUSIONS	We conclude that yoga is an effective complementary health approach for improving quality of life in menopausal women .
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-###24928802
-BACKGROUND	Constipation has a significant impact on quality of life .
-BACKGROUND	Aim of this study was to evaluate the safety and the efficacy for relieving dyschezia symptoms of a CO2-releasing suppository in a randomized , placebo-controlled , clinical trial .
-METHODS	Fifty-three office-based primary care physicians and 24 gastroenterologists conducted the study in France , between November 2010 and January 2012 .
-METHODS	Patients ( aged 18-75 years ) with dyschezia were eligible .
-METHODS	Patients were randomly allocated a once-a-day suppository ( CO2-releasing suppository or placebo ) for 21 days .
-METHODS	Primary endpoint was the change , from Day 0 to Day 21 , in the intensity of discomfort related to dyschezia based on a self-assessed 0-100 visual analogue scale .
-RESULTS	A total of 323 patients were randomized , i.e. 166 into the intervention group and 157 into the placebo group .
-RESULTS	Co-variance analysis showed a greater reduction in discomfort visual analogue scale score in the intervention group ( -34.5 mm ; standard error of the mean : 1.8 mm ) than in the placebo group ( -26.2 mm ; standard error of the mean : 1.9 mm ; p < 0.001 ) .
-RESULTS	The greater efficacy of the CO2-releasing suppository was confirmed for all secondary efficacy parameters .
-RESULTS	No significant side effects for either treatment were observed .
-CONCLUSIONS	A CO2-releasing suppository is more effective than a placebo for the relief of symptoms of dyschezia .
-CONCLUSIONS	This efficacy is associated with a good safety profile .
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-###24499812
-BACKGROUND	Tubal ectopic pregnancy can be surgically treated by salpingectomy , in which the affected Fallopian tube is removed , or salpingotomy , in which the tube is preserved .
-BACKGROUND	Despite potentially increased risks of persistent trophoblast and repeat ectopic pregnancy , salpingotomy is often preferred over salpingectomy because the preservation of both tubes is assumed to offer favourable fertility prospects , although little evidence exists to support this assumption .
-BACKGROUND	We aimed to assess whether salpingotomy would improve rates of ongoing pregnancy by natural conception compared with salpingectomy .
-METHODS	In this open-label , multicentre , international , randomised controlled trial , women aged 18 years and older with a laparoscopically confirmed tubal pregnancy and a healthy contralateral tube were randomly assigned via a central internet-based randomisation program to receive salpingotomy or salpingectomy .
-METHODS	The primary outcome was ongoing pregnancy by natural conception .
-METHODS	Differences in cumulative ongoing pregnancy rates were expressed as a fecundity rate ratio with 95 % CI , calculated by Cox proportional-hazards analysis with a time horizon of 36 months .
-METHODS	Secondary outcomes were persistent trophoblast and repeat ectopic pregnancy ( expressed as relative risks [ RRs ] with 95 % CIs ) and ongoing pregnancy after ovulation induction , intrauterine insemination , or IVF .
-METHODS	The researchers who collected data for fertility outcomes were masked to the assigned intervention , but patients and the investigators who analysed the data were not .
-METHODS	All endpoints were analysed by intention to treat .
-METHODS	We also did a ( non-prespecified ) meta-analysis that included the findings from the present trial .
-METHODS	This trial is registered , number ISRCTN37002267 .
-RESULTS	446 women were randomly assigned between Sept 24 , 2004 , and Nov 29 , 2011 , with 215 allocated to salpingotomy and 231 to salpingectomy .
-RESULTS	Follow-up was discontinued on Feb 1 , 2013 .
-RESULTS	The cumulative ongoing pregnancy rate was 607 % after salpingotomy and 562 % after salpingectomy ( fecundity rate ratio 106 , 95 % CI 081-138 ; log-rank p = 0678 ) .
-RESULTS	Persistent trophoblast occurred more frequently in the salpingotomy group than in the salpingectomy group ( 14 [ 7 % ] vs 1 [ < 1 % ] ; RR 150 , 20-1134 ) .
-RESULTS	Repeat ectopic pregnancy occurred in 18 women ( 8 % ) in the salpingotomy group and 12 ( 5 % ) women in the salpingectomy group ( RR 16 , 08-33 ) .
-RESULTS	The number of ongoing pregnancies after ovulation induction , intrauterine insemination , or IVF did not differ significantly between the groups .
-RESULTS	43 ( 20 % ) women in the salpingotomy group were converted to salpingectomy during the initial surgery because of persistent tubal bleeding .
-RESULTS	Our meta-analysis , which included our own results and those of one other study , substantiated the results of the trial .
-CONCLUSIONS	In women with a tubal pregnancy and a healthy contralateral tube , salpingotomy does not significantly improve fertility prospects compared with salpingectomy .
-BACKGROUND	Netherlands Organisation for Health Research and Development ( ZonMW ) , Region Vstra Gtaland Health & Medical Care Committee .
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-###24270743
-OBJECTIVE	To examine the diagnostic accuracy of novel biomarkers of myocardial injury and troponin assays for diagnosis of myocardial infarction .
-METHODS	850 patients randomised to the point-of-care testing arm of the Randomised Assessment of Panel Assay of Cardiac markers ( RATPAC ) study in six emergency departments of low-risk patients presenting with chest pain were studied .
-METHODS	Blood samples were obtained on admission and 90 min from admission .
-METHODS	Myocardial infarction was defined by the universal definition of myocardial infarction .
-METHODS	The following diagnostic strategies were compared by receiver operator characteristic curve analysis and comparison of area under the curve : individual marker values and the combination of presentation heart fatty acid binding protein ( HFABP ) and copeptin with troponin .
-RESULTS	68 patients had a final diagnosis of myocardial infarction .
-RESULTS	Admission samples were available from 838/1132 patients enrolled in the study .
-RESULTS	Areas under the curve were as follows ( CIs in parentheses ) : cardiac troponin I ( cTnI ) Stratus CS 0.94 ( 0.90 to 0.98 ) , cTnI Beckmann 0.92 ( 0.88 to 0.96 ) , cTnI Siemens ultra 0.90 ( 0.85 to 0.95 ) , cardiac troponin T high sensitivity 0.92 ( 0.88 to 0.96 ) , HFABP 1 0.84 ( 0.77 to 0.90 ) copeptin 0.62 ( 0.57 to 0.68 ) .
-RESULTS	HFABP and copeptin were diagnostically inferior to troponin .
-RESULTS	The combination of HFABP ( at the 95th percentile ) and troponin ( at the 99th percentile ) increased diagnostic sensitivity .
-CONCLUSIONS	High-sensitivity cardiac troponin is the best single marker .
-CONCLUSIONS	Addition of HFABP to high-sensitivity troponin increased diagnostic sensitivity .
-CONCLUSIONS	Additional measurement of copeptin is not useful in the chest pain population .
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-###25031187
-BACKGROUND	Multidimensional tinnitus models describe dysfunctional cognitions as a complicating factor in the process of tinnitus habituation .
-BACKGROUND	However , this concept has rarely been investigated in previous research .
-OBJECTIVE	The present study investigated the effects of two cognitive-behavioral treatments on dysfunctional tinnitus-related cognitions in patients with chronic tinnitus .
-OBJECTIVE	Furthermore , dysfunctional cognitions were examined as possible predictors of the therapeutic effect on tinnitus distress .
-METHODS	A total of 128 patients with chronic tinnitus were randomly assigned to either an Internet-delivered guided self-help treatment ( Internet-based cognitive-behavioral therapy , ICBT ) , a conventional face-to-face group therapy ( cognitive-behavioral group therapy , GCBT ) , or an active control group in the form of a web-based discussion forum ( DF ) .
-METHODS	To assess tinnitus-related dysfunctional thoughts , the Tinnitus Cognitions Scale ( T-Cog ) was used at pre - and post-assessment , as well as at the 6 - and 12-month follow-up .
-RESULTS	Multivariate ANOVAs with post hoc tests revealed significant and comparable reductions of dysfunctional tinnitus-related cognitions for both treatments ( GCBT and ICBT ) , which remained stable over a 6 - and 12-month period .
-RESULTS	Negative correlations were found between the catastrophic subscale of the T-Cog and therapy outcome for ICBT , but not for GCBT .
-RESULTS	This means a higher degree of catastrophic thinking at baseline was associated with lower benefit from ICBT directly after the treatment .
-RESULTS	Hierarchical regression analysis confirmed catastrophizing as a predictor of poorer therapy outcome regarding emotional tinnitus distress in ICBT .
-RESULTS	No associations were detected in the follow-up assessments .
-CONCLUSIONS	Both forms of CBT are successful in reducing dysfunctional tinnitus-related cognitions .
-CONCLUSIONS	Catastrophizing significantly predicted a less favorable outcome regarding emotional tinnitus distress in ICBT .
-CONCLUSIONS	Clinical implications of these results are described .
-CONCLUSIONS	Dysfunctional cognitions could be targeted more intensively in therapy and in future research on tinnitus .
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-###24706369
-OBJECTIVE	Handling emergency telephone consultations ( ETCs ) is a challenging and very important task for doctors .
-OBJECTIVE	The aims of the study were to document insecurity in medical students during ETCs and to identify the reasons for that insecurity .
-OBJECTIVE	We hypothesised that insecurity is associated with advising more urgent action ( e.g. advice to call for an ambulance ) in ETCs .
-METHODS	We used ETCs with simulated patients ( SPs ) , with each student randomly allocated two of four possible cases .
-METHODS	After the training , 137 students reported on any insecurity that they had in the various ETC phases .
-METHODS	We analysed the reasons for insecurity using descriptive statistics .
-METHODS	The association between the students ' advice that urgent action was needed and their insecurity was analysed with Spearman rank correlation .
-RESULTS	Overall , 95 % of the students felt insecure in at least one phase of their ETC. .
-RESULTS	History taking was the phase in which students felt most insecure ( 63.1 % ) , followed by the phase of analysing the information given by the patient ( 44.9 % ) .
-RESULTS	Perceived insecurity was associated with more urgent advice in one case scenario ( abdominal pain ; correlation r = 0.46 ; p < 0.01 ) .
-RESULTS	The other two cases ( child with fever ; chest pain ) also had a positive , but not statistically significant , correlation trend ( p < 0.12 ; p < 0.08 ) .
-CONCLUSIONS	Insecurity is highly prevalent among medical students in their ETC decision-making .
-CONCLUSIONS	ETC training in medical schools , with a focus on structured history taking and formulating discriminating questions , might help decrease insecurity in ETCs .
-CONCLUSIONS	Medical education should also teach management of insecurity .
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-###25511347
-OBJECTIVE	We investigated the efficacy of intravenous ( IV ) preemptive paracetamol on postoperative total fentanyl consumption and fentanyl-related side effects in patients undergoing open nephrectomy .
-METHODS	A total of 60 patients scheduled for elective open nephrectomy under general anesthesia were included .
-METHODS	All patients received Patient-controlled IV analgesia with fentanyl postoperatively .
-METHODS	Patients were randomly allocated into three equal groups : The fentanyl group received 100 mL of IV normal saline as a placebo , with the first dose ending 30 min before intubation .
-METHODS	In paracetamol group , IV 1 g paracetamol was given to the patients 30 min after extubation with repeated doses every 6 h totally 4 times a day .
-METHODS	In preemptive paracetamol group , patients received IV 1 g paracetamol every 6 h , with the first dose ending 30 min before intubation .
-RESULTS	Postoperative cumulative fentanyl consumption for 24 h was significantly higher in the fentanyl group ( 1009 139.361 g ) than those of paracetamol ( 752.25 112.665 g ) and preemptive paracetamol groups ( 761.10 226.625 g ) ( P = 0.001 for both ) .
-RESULTS	In early postoperative period ( 0-4 h ) ; whereas total fentanyl consumption showed no statistically significant difference among groups ( P = 0.186 ) , the nausea-vomiting scores were significantly higher in the fentanyl group compared with other groups ( P = 0.012 ) .
-CONCLUSIONS	In patients undergoing open nephrectomy , use of preemptive or postoperative paracetamol reduces fentanyl related nausea-vomiting without a decrease in total fentanyl consumption in the early postoperative period .
-CONCLUSIONS	Furthermore , use of preemptive or postoperative paracetamol reduces total fentanyl requirements in the first 24 h postoperatively providing a safe and effective postoperative analgesia .
-
-###25677309
-BACKGROUND	Brain lesions on diffusion-weighted imaging ( DWI ) are frequently found after carotid artery stenting ( CAS ) , but their clinical relevance remains unclear .
-OBJECTIVE	This study sought to investigate whether periprocedural ischemic DWI lesions after CAS or carotid endarterectomy ( CEA ) are associated with an increased risk of recurrent cerebrovascular events .
-METHODS	In the magnetic resonance imaging ( MRI ) substudy of ICSS ( International Carotid Stenting Study ) , 231 patients with symptomatic carotid stenosis were randomized to undergo CAS ( n = 124 ) or CEA ( n = 107 ) .
-METHODS	MRIs were performed 1 to 7 days before and 1 to 3 days after treatment .
-METHODS	The primary outcome event was stroke or transient ischemic attack in any territory occurring between the post-treatment MRI and the end of follow-up .
-METHODS	Time to occurrence of the primary outcome event was compared between patients with ( DWI + ) and without ( DWI - ) new DWI lesions on the post-treatment scan in the CAS and CEA groups separately .
-RESULTS	Median time of follow-up was 4.1 years ( interquartile range : 3.0 to 5.2 ) .
-RESULTS	In the CAS group , recurrent stroke or transient ischemic attack occurred more often among DWI + patients ( 12 of 62 ) than among DWI - patients ( 6 of 62 ) , with a cumulative 5-year incidence of 22.8 % ( standard error [ SE ] : 7.1 % ) and 8.8 % ( SE : 3.8 % ) , respectively ( unadjusted hazard ratio : 2.85 ; 95 % confidence interval : 1.05 to 7.72 ; p = 0.04 ) .
-RESULTS	In DWI + and DWI - patients , 8 and 2 events , respectively , occurred within 6 months after treatment .
-RESULTS	In the CEA group , there was no difference in recurrent cerebrovascular events between DWI + and DWI - patients .
-CONCLUSIONS	Ischemic brain lesions discovered on DWI after CAS seem to be a marker of increased risk for recurrent cerebrovascular events .
-CONCLUSIONS	Patients with periprocedural DWI lesions might benefit from more aggressive and prolonged antiplatelet therapy after CAS .
-CONCLUSIONS	( A Randomised Comparison of the Risks , Benefits and Cost Effectiveness of Primary Carotid Stenting With Carotid Endarterectomy : International Carotid Stenting Study ; ISRCTN25337470 ) .
-
-###25817472
-BACKGROUND	Misoprostol is established for the treatment of incomplete abortion but has not been systematically assessed when provided by midwives at district level in a low-resource setting .
-BACKGROUND	We investigated the effectiveness and safety of midwives diagnosing and treating incomplete abortion with misoprostol , compared with physicians .
-METHODS	We did a multicentre randomised controlled equivalence trial at district level at six facilities in Uganda .
-METHODS	Eligibility criteria were women with signs of incomplete abortion .
-METHODS	We randomly allocated women with first-trimester incomplete abortion to clinical assessment and treatment with misoprostol either by a physician or a midwife .
-METHODS	The randomisation ( 1:1 ) was done in blocks of 12 and was stratified for study site .
-METHODS	Primary outcome was complete abortion not needing surgical intervention within 14-28 days after initial treatment .
-METHODS	The study was not masked .
-METHODS	Analysis of the primary outcome was done on the per-protocol population with a generalised linear-mixed effects model .
-METHODS	The predefined equivalence range was -4 % to 4 % .
-METHODS	The trial was registered at ClinicalTrials.gov , number NCT01844024 .
-RESULTS	From April 30 , 2013 , to July 21 , 2014 , 1108 women were assessed for eligibility .
-RESULTS	1010 women were randomly assigned to each group ( 506 to midwife group and 504 to physician group ) .
-RESULTS	955 women ( 472 in the midwife group and 483 in the physician group ) were included in the per-protocol analysis .
-RESULTS	452 ( 958 % ) of women in the midwife group had complete abortion and 467 ( 967 % ) in the physician group .
-RESULTS	The model-based risk difference for midwife versus physician group was -08 % ( 95 % CI -29 to 14 ) , falling within the predefined equivalence range ( -4 % to 4 % ) .
-RESULTS	The overall proportion of women with incomplete abortion was 38 % ( 36/955 ) , similarly distributed between the two groups ( 42 % [ 20/472 ] in the midwife group , 33 % [ 16/483 ] in the physician group ) .
-RESULTS	No serious adverse events were recorded .
-CONCLUSIONS	Diagnosis and treatment of incomplete abortion with misoprostol by midwives is equally safe and effective as when provided by physicians , in a low-resource setting .
-CONCLUSIONS	Scaling up midwives ' involvement in treatment of incomplete abortion with misoprostol at district level would increase access to safe post-abortion care .
-BACKGROUND	The Swedish Research Council , Karolinska Institutet , and Dalarna University .
-
-###24398076
-BACKGROUND	Much of the existing literature on physical activity ( PA ) interventions involves physically inactive individuals recruited from community settings rather than clinical practice settings .
-BACKGROUND	Recruitment of patients into interventions in clinical practice settings is difficult due to limited time available in the clinic , identification of appropriate personnel to efficiently conduct the process , and time-consuming methods of recruitment .
-BACKGROUND	The purpose of this report is to describe the approach used to identify and recruit veterans from the Veterans Affairs ( VA ) Pittsburgh Healthcare System Primary Care Clinic into a randomized controlled PA study .
-METHODS	A sampling frame of veterans was developed using the VA electronic medical record .
-METHODS	During regularly scheduled clinic appointments , primary care providers ( PCPs ) screened identified patients for safety to engage in moderate-intensity PA and willingness to discuss the study with research staff members .
-METHODS	Research staff determined eligibility with a subsequent telephone screening call and scheduled a research study appointment , at which time signed informed consent and baseline measurements were obtained .
-RESULTS	Of the 3,482 veterans in the sampling frame who were scheduled for a primary care appointment during the study period , 1,990 ( 57.2 % ) were seen in the clinic and screened by the PCP ; moderate-intensity PA was deemed safe for 1,293 ( 37.1 % ) , 871 ( 25.0 % ) agreed to be contacted for further screening , 334 ( 9.6 % ) were eligible for the study , and 232 ( 6.7 % ) enrolled .
-CONCLUSIONS	Using a semiautomated screening approach that combined an electronically-derived sampling frame with paper and pencil prescreening by PCPs and research staff , VA-STRIDE was able to recruit 1 in 15 veterans in the sampling frame .
-CONCLUSIONS	Using this approach , a high proportion of potentially eligible veterans were screened by their PCPs .
-BACKGROUND	Clinical trials.gov identifier : NCT00731094 .
-
-###24700403
-OBJECTIVE	We tested the hypothesis that clevidipine , a rapidly acting dihydropyridine calcium channel blocker , is not inferior to nitroglycerin ( NTG ) in controlling blood pressure before cardiopulmonary bypass ( CPB ) during coronary artery bypass grafting ( CABG ) .
-METHODS	In this double-blind study from October 4 , 2003 to April 26 , 2004 , 100 patients undergoing CABG with CPB were randomized at four centres to receive intravenous infusions of clevidipine ( 0.2-8gkg ( -1 ) min ( -1 ) ) or NTG ( 0.4 gkg ( -1 ) min ( -1 ) to a clinician-determined maximum dose rate ) from induction of anesthesia through 12hr postoperatively .
-METHODS	The study drug was titrated in the pre-CPB period with the aim of maintaining mean arterial pressure ( MAP ) within 5mmHg of a clinician-predetermined target .
-METHODS	The primary endpoint was the area under the curve ( AUC ) for the total time each patient 's MAP was outside the target range from drug initiation to the start of CPB , normalized per hour ( AUCMAP-D ) .
-METHODS	The predefined non-inferiority criterion for the primary endpoint was a 95 % confidence interval ( CI ) upper limit no greater than 1.50 for the geometric means ratio between clevidipine and NTG .
-RESULTS	Total mean [ standard deviation ( SD ) ] dose pre-bypass was 4.5 ( 4.7 ) mg for clevidipine and 6.9 ( 5.4 ) mg for NTG ( P < 0.05 ) .
-RESULTS	The geometric mean AUCMAP-D for clevidipine was 283mmHgminhr ( -1 ) ( n = 45 ) and for NTG was 292mmHgminhr ( -1 ) ( n = 48 ) ; the geometric means ratio was 0.97 ( 95 % CI 0.74 to 1.27 ) .
-RESULTS	The geometric mean AUCMAP-D during aortic cannulation was 357.7 mmHgminhr ( -1 ) for clevidipine compared with 190.5 mmHgminhr ( -1 ) for NTG .
-RESULTS	Mean ( SD ) heart rate with clevidipine was 76.0 ( 13.8 ) beatsmin ( -1 ) compared with 81.5 ( 14.4 ) beatsmin ( -1 ) for NTG .
-RESULTS	There were no clinically important differences between groups in adverse events .
-CONCLUSIONS	During CABG , clevidipine was not inferior to NTG for blood pressure control pre-bypass .
-
-###25877711
-OBJECTIVE	To observe the efficacy of bromfenac sodium eye drops on relieving the irritative symptoms after LASEK surgery .
-METHODS	Sixty-four people who had received LASEK surgery were randomly divided into two groups , observing the right eye for each group .
-METHODS	group A was given 0.1 % bromfenac sodium eye drops twice a day in three days before surgery and one day after surgery ; group B was given 0.5 % ketorolac tromethamine ( acular ) eye drops four times a day in three days before surgery and on day after surgery .
-METHODS	In the 1 ( st ) , 3 ( rd ) , 5 ( th ) and 7 ( th ) day after surgery , irritative symptoms grade , duration of irritation , time for corneal epithelial healing , and uncorrected visual acuity were observed and compared between the two groups .
-RESULTS	0.1 % no discomfort in group A with bromfenac sodium eye drops was observed while 0.5 % ketorolac tromethamine eye drops caused tingling , burning discomfort that lasted for 2-3 seconds in 16 of the 28 subjects ( 87.5 % ) .
-RESULTS	No significant difference was observed between the irritation grades of group A and B ( Z = -1.625 , P = 0.104 ) ; the duration of irritative symptom was significantly shorter in group A than that in group B ( Z = -2.895 , P = 0.004 ) .
-RESULTS	No significant difference was observed between the time of healing and visual acuity recovery of the two groups .
-CONCLUSIONS	0.1 % bromfenac sodium eye drops can effectively relieve the post-LASEK irritative symptoms , and it is better tolerated than 0.5 % ketorolac tromethamine eye drops .
-
-###25248497
-BACKGROUND	Postnatal common mental disorders among women are an important public health problem internationally .
-BACKGROUND	Interventions to prevent postnatal depression have had limited success .
-BACKGROUND	What Were We Thinking ( WWWT ) is a structured , gender-informed , psychoeducational group programme for parents and their first infant that addresses two modifiable risks to postnatal mental health .
-BACKGROUND	This paper describes the protocol for a cluster randomised controlled trial to test the clinical effectiveness and cost-effectiveness of WWWT when implemented in usual primary care .
-METHODS	48 maternal and child health ( MCH ) centres from six diverse Local Government Areas , in Victoria , Australia are randomly allocated to the intervention group ( usual care plus WWWT ) or the control group ( usual care ) .
-METHODS	The required sample size is 184 women in each group .
-METHODS	English-speaking primiparous women receiving postpartum healthcare in participating MCH centres complete two computer-assisted telephone interviews : baseline at 4weeks and outcome at 6months postpartum .
-METHODS	Women attending intervention MCH centres are invited to attend WWWT in addition to usual care .
-METHODS	The primary outcome is meeting Diagnostic and Statistical Manual-IV ( DSM-IV ) diagnostic criteria for major depressive episode ; generalised anxiety disorder ; panic disorder with or without agoraphobia , agoraphobia with or without panic , social phobia , adult separation anxiety or adjustment disorder with depressed mood , anxiety or mixed depressed mood and anxiety within the past 30days at 6months postpartum .
-METHODS	Secondary outcomes are self-rated general and emotional health , infant sleep problems , method of infant feeding , quality of mother-infant relationship and intimate partner relationship , and healthcare costs and outcomes .
-BACKGROUND	Approval to conduct the study has been granted .
-BACKGROUND	A comprehensive dissemination plan has been devised .
-BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12613000506796 .
-BACKGROUND	UTN : U1111-1125-8208 .
-
-###24300131
-BACKGROUND	To evaluate the efficacy of the surgical fat-filling procedure ( SFFP ) in the treatment of refractory cough and quality of life ( QOL ) after systematic mediastinal lymphadenectomy in patients with right lung cancer .
-METHODS	This is a blinded , randomized , controlled clinical trial to evaluate refractory cough and QOL in patients after mediastinal lymphadenectomy for lung cancer .
-METHODS	One hundred eligible lung cancer patients were randomly divided into two groups : the fat-filling group and non-filling group .
-METHODS	In the fat-filling group , post-lymphadenectomy residual cavities ( PLRCs ) were filled with fatty tissue autografts after lymph node dissection .
-METHODS	In the non-filling group , the PLRCs remained unfilled .
-METHODS	Clinical endpoints were postoperative cough score and QOL .
-RESULTS	The SFFP did not increase intraoperative bleeding , extend operation time , or hospital stay .
-RESULTS	Further , night cough was significantly improved after 4wk in the fat-filling group after the removal of a chest drainage tube .
-RESULTS	QOL issues , such as emotional condition , functional status , and additional concerns , demonstrated a remarkable improvement in the fat-filling group at postoperative 1mo compared with the non-filling ( control ) group .
-CONCLUSIONS	This study demonstrates that filling PLRCs with fatty tissue autografts is a safe and partially effective treatment for refractory cough after major pulmonary resection and mediastinal lymphadenectomy .
-CONCLUSIONS	This novel procedure significantly improved patient QOL and may prove useful as a relatively safe preventive surgical adjunct operation for refractory cough .
-
-###24337761
-OBJECTIVE	Modafinil has been reported to benefit a subgroup of patients suffering severe fatigue while undergoing chemotherapy .
-OBJECTIVE	Docetaxel is associated with fatigue that may lead to premature therapy withdrawal .
-OBJECTIVE	We investigated whether modafinil could reduce fatigue during docetaxel chemotherapy .
-METHODS	This multicenter , randomized , double-blind , placebo-controlled study evaluated the efficacy of modafinil in patients with metastatic prostate or breast cancer undergoing docetaxel chemotherapy ( every 21 days ; minimum dose 50 mg/m ( 2 ) ) .
-METHODS	At the start of their third or subsequent chemotherapy cycle , patients with significant docetaxel-associated fatigue were randomized to receive concurrent modafinil 200 mg/day or placebo for 15 days ( `` treatment periods '' ( TP ) ) .
-METHODS	Docetaxel was continued for up to four further cycles .
-METHODS	Fatigue was evaluated with the fatigue component of the MD Anderson Symptom Inventory ( MDASI ) .
-METHODS	The primary endpoint was cumulative MDASI area under the curve ( AUC ) during the first 7 days of study medication during TP1 and TP2 .
-RESULTS	Evaluable data were available from 83 patients ( 65 with prostate cancer ) .
-RESULTS	There was no statistically significant difference between the two treatment arms for the primary endpoint ( MSADI AUC3-10 35.9 vs 39.6 ; 95 % confidence interval -8.9 , 1.4 ; P = 0.15 ) .
-RESULTS	Overall toxicity was comparable between treatment groups ; however , the incidence of grade 2 nausea and vomiting was higher in the modafinil arm ( 45.4 vs 25 % ) .
-CONCLUSIONS	Assessing and managing chemotherapy-related fatigue remains a major challenge .
-CONCLUSIONS	There was a lack of difference between the two arms in the planned primary endpoint .
-CONCLUSIONS	However , there was a modest but consistent trend towards improvement of docetaxel-related fatigue in those treated with modafinil .
-CONCLUSIONS	Based on the study findings , modafinil for the treatment of fatigue associated with docetaxel chemotherapy elicits modest improvements .
-CONCLUSIONS	Larger , longer term , randomized , controlled studies are required to clarify the exact role of modafinil in the treatment of docetaxel-related fatigue .
-
-###25275672
-BACKGROUND	Topiramate ( TOP ) and anticonvulsants in general are considered safe and effective drugs for the treatment of alcohol dependence , even though TOP-induced adverse events are quite common , especially for high initial doses or if titration to 300 mg/d is too rapid .
-BACKGROUND	The aim of the present study was to assess the efficacy and tolerability profile of low-dose TOP for relapse prevention .
-METHODS	After detoxification , 52 patients were randomized into 2 groups as follows : 26 patients received 100 mg of TOP ( oral , twice daily ) , titrated over 2 weeks , and 26 patients received placebo ( PLA ) .
-METHODS	Both groups underwent rehabilitation twice a week .
-RESULTS	After 6 weeks of treatment , compared with the PLA group , patients receiving TOP showed the following : ( 1 ) fewer drinking days ( P < 0.05 ) ; ( 2 ) less daily alcohol consumption ( P < 0.05 ) ; ( 3 ) more days of treatment ( P < 0.05 ) ; ( 4 ) reduced levels of craving ( Obsessive-Compulsive Drinking Scale ) and withdrawal symptoms ( Clinical Institute Withdrawal Assessment for Alcohol-Revised ) ; and ( 5 ) improvement of anxiety , depression , and obsessive-compulsive symptom severity ( Symptom Check List 90 Revised ) .
-CONCLUSIONS	Despite the small sample size and the short follow-up period , the present PLA-controlled study demonstrated the potential usefulness of TOP , even when administered at a dosage of 100 mg/d , for the treatment of detoxified alcohol-dependent subjects , confirming results from previous studies testing higher doses of TOP .
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-###24798104
-BACKGROUND	Sympathectomy is currently used as the fourth step of the modified World Health Organization ( WHO ) analgesic ladder .
-BACKGROUND	Sympathectomy can be performed early , before the second step on the ladder .
-OBJECTIVE	We hypothesized that early sympathectomy would reduce pain and opioid consumption and improve quality of life .
-METHODS	One hundred nine patients , with inoperable abdominal or pelvic cancer , reporting visceral pain of 40-70 on a visual analogue scale and taking nonopioid analgesics were allocated randomly into two groups : either blocks were performed before Step 2 of the WHO ladder , then analgesics were managed according to the ladder ( Group I ) or analgesics were given according to the WHO ladder , and blocks were performed as the fourth step after failure of strong opioids to control pain ( Group II ) .
-METHODS	Visual analogue scale scores , responder analysis , daily opioid consumption , related side effects , and quality of life were assessed .
-RESULTS	Responders were significantly higher in Group I ( P < 0.0001 ) , and partial responders and nonresponders significantly increased in Group II ( P < 0.0001 and 0.006 , respectively ) .
-RESULTS	Opioid consumption significantly decreased in Group I ( P < 0.0001 during first 12 months and 0.007 at the last assessment time ) , with concomitant significant reduction in related side effects .
-RESULTS	The number of patients who had a good analgesic response on tramadol significantly increased in Group I during the first five months ( P < 0.05 ) .
-RESULTS	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 global quality-of-life subscale scores revealed significant improvement until the fifth month in Group I ( P < 0.05 ) .
-CONCLUSIONS	Sympathectomy before Step 2 on the WHO analgesic ladder seems to lead to better pain control , less opioid consumption , and better quality of life in cancer patients .
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-###24628898
-OBJECTIVE	To study the effects of oromucosal detomidine gel administered sublingually to calves prior to disbudding , and to compare its efficacy with intravenously ( IV ) administered detomidine .
-METHODS	Randomised , prospective clinical study .
-METHODS	Twenty dairy calves aged 12.4 4.4 days ( mean SD ) , weight 50.5 9.0 kg .
-METHODS	Detomidine at 80 g kg ( -1 ) was administered to ten calves sublingually ( GEL ) and at 30 g kg ( -1 ) to ten control calves IV ( V. jugularis ) .
-METHODS	Meloxicam ( 0.5 mg kg ( -1 ) ) and local anaesthetic ( lidocaine 3 mg kg ( -1 ) ) were administered before heat cauterization of horn buds .
-METHODS	Heart rate ( HR ) , body temperature and clinical sedation were monitored over 240 minutes .
-METHODS	Blood was collected from the V. cephalica during the same period for drug concentration analysis .
-METHODS	Pharmacokinetic variables were calculated from the plasma detomidine concentration-time data using non-compartmental methods .
-METHODS	Statistical analyses compared routes of administration by Student 's t-test and linear mixed models as relevant .
-RESULTS	The maximum plasma detomidine concentration after GEL was 2.1 1.2 ng mL ( -1 ) ( mean SD ) and the time of maximum concentration was 66.0 36.9 minutes .
-RESULTS	The bioavailability of detomidine was approximately 34 % with GEL .
-RESULTS	Similar sedation scores were reached in both groups after administration of detomidine , but maximal sedation was reached earlier in the IV group ( 10 minutes ) than in the GEL group ( 40 minutes ) .
-RESULTS	HR was lower after IV than GEL from 5 to 10 minutes after administration .
-RESULTS	All animals were adequately sedated , and we were able to administer local anaesthetic without resistance to all of the calves before disbudding .
-CONCLUSIONS	Oromucosally administered detomidine is an effective sedative agent for calves prior to disbudding .
-
-###25608502
-BACKGROUND	Several studies have demonstrated that local ischemic preconditioning can reduce myocardial ischemia-reperfusion injury in cardiac surgery patients ; however , preconditioning has not become a standard cardioprotective intervention , primarily because of the increased risk of atheroembolism during repetitive aortic cross-clamping .
-BACKGROUND	In the present study , we aimed to describe and validate a novel technique of preconditioning induction .
-METHODS	Patients undergoing coronary artery bypass grafting ( 12 women and 78 men ; mean age , 5611years ) were randomized into 3 groups : ( 1 ) Controls ( n = 30 ) , ( 2 ) Perfusion ( n = 30 ) , and ( 3 ) Preconditioning ( n = 30 ) .
-METHODS	All patients were operated under cardiopulmonary bypass using normothermic blood cardioplegia .
-METHODS	Preconditioning was induced by subjecting the hemodynamically unloaded heart to 2cycles of 3min of ischemia and 3min of reperfusion with normokalemic blood prior to cardioplegia .
-METHODS	In the Perfusion group , the heart perfusion remained unaffected for 12min .
-METHODS	Troponin I ( TnI ) levels were analyzed before surgery , and 12 , 24 , 48h , and 7days after surgery .
-METHODS	The secondary endpoints included the cardiac index , plasma natriuretic peptide level , and postoperative use of inotropes .
-RESULTS	Preconditioning resulted in a significant reduction in the TnI level on the 7th postoperative day only ( 0.100.05 and 0.330.88 ng/ml in Preconditioning and Perfusion groups , respectively , P < 0.05 ) .
-RESULTS	In addition , cardiac index was significantly higher in the Preconditioning group than in the Control and Perfusion groups just after weaning from cardiopulmonary bypass .
-RESULTS	The number of patients requiring inotropic support with2 agents after surgery was significantly lower in the Preconditioning and Perfusion group than in the Control group ( P < 0.05 ) .
-RESULTS	No complications of the procedure were recorded in the Preconditioning group .
-CONCLUSIONS	The preconditioning procedure described can be performed safely in cardiac surgery patients .
-CONCLUSIONS	The application of this technique of preconditioning was associated with certain benefits , including improved left ventricular function after weaning from cardiopulmonary bypass and a reduced need for inotropic support .
-CONCLUSIONS	However , the infarct-limiting effect of preconditioning in the early postoperative period was not evident .
-CONCLUSIONS	The procedure does not involve repetitive aortic cross-clamping , thus avoiding possible embolic complications .
-
-###24920841
-BACKGROUND	Minimal-change nephrotic syndrome ( MCNS ) is a common cause of steroid sensitive nephrotic syndrome ( NS ) with frequent relapse .
-BACKGROUND	Although steroids and calcineurin inhibitors ( CNIs ) are the cornerstone treatments , the use of rituximab ( RTX ) , a monoclonal antibody targeting B cells , is an efficient and safe alternative in childhood .
-METHODS	Because data from adults remain sparse , we conducted a large retrospective and multicentric study that included 41 adults with MCNS and receiving RTX .
-RESULTS	Complete ( NS remission and withdrawal of all immunosuppressants ) and partial ( NS remission and withdrawal of at least one immunosuppressants ) clinical responses were obtained for 25 and 7 patients , respectively ( overall response 78 % ) , including 3 patients that only received RTX and had a complete clinical response .
-RESULTS	After a follow-up time of 39 months ( 6-71 ) , relapses occurred in 18 responder patients [ 56 % , median time 18 months ( 3-36 ) ] .
-RESULTS	Seventeen of these received a second course of RTX and then had a complete ( n = 13 ) or partial ( n = 4 ) clinical response .
-RESULTS	From multivariate analysis , on-going mycophenolate mofetil ( MMF ) therapy at the time of RTX was the only predictive factor for RTX failure [ HR = 0.07 95 % CI ( 0.01-0 .04 ) , P = 0.003 ] .
-RESULTS	Interestingly , nine patients were still in remission at 14 months ( 3-36 ) after B-cell recovery .
-RESULTS	No significant early or late adverse event occurred after RTX therapy .
-CONCLUSIONS	RTX is safe and effective in adult patients with MCNS and could be an alternative to steroids or CNIs in patients with a long history of relapsing MCNS .
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-###24240384
-OBJECTIVE	Extracorporeal circulation ( ECC ) of blood during cardiopulmonary surgery has been shown to stimulate various proinflammatory molecules such as cytokines and chemokines .
-OBJECTIVE	The biochemical oxidation/reduction pathways of - lipoic acid suggest that it may have antioxidant properties .
-METHODS	In this study we aimed to evaluate only patients with coronary heart disease and those planned for coronary artery bypass graft operation .
-METHODS	Blood samples were obtained from the patients before the operation ( P1 ) and one ( P2 ) , four ( P3 ) , 24 ( P4 ) and 48 hours ( P5 ) after administration of - lipoic acid ( LA ) .
-METHODS	The patients were divided into two groups , control and LA treatment group .
-METHODS	Levels of interleukin - 6 ( IL-6 ) and -8 ( IL-8 ) , complement 3 ( C3 ) and 4 ( C4 ) , anti-streptolysin ( ASO ) , C-reactive protein ( CRP ) and haptoglobin were assessed in the blood samples .
-RESULTS	Cytokine IL-6 and IL-8 levels were significantly higher after surgery .
-RESULTS	Compared with the control groups , LA significantly decreased IL-6 and IL-8 levels in a time-dependent manner .
-RESULTS	CRP levels did not show significant variation in the first three time periods .
-RESULTS	CRP levels were higher after surgery , especially in the later periods .
-RESULTS	These results demonstrate that CRP formation depends on cytokine release .
-RESULTS	C3 and C4 levels were significantly higher after surgery than in the pre-operative period .
-RESULTS	LA treatment decreased C3 and C4 levels .
-RESULTS	Therefore , LA administration may be useful for the treatment of diseases and processes where excessive cytokine release could cause oxidative damage .
-CONCLUSIONS	Our findings suggest a possible benefit of using LA during cardiac surgery to reduce cytokine levels .
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-###24503408
-OBJECTIVE	To study the intraocular distribution and safety of polymethylmethacrylate nanoparticles loaded with carboplatin after posterior subtenon injection in humans .
-METHODS	Prospective , interventional , comparative case series .
-METHODS	Six patients ( mean age : 26.83 7.5 years ) , scheduled to undergo planned uniocular enucleation in aninstitutional setting , were randomly divided into 3 groups .
-METHODS	Each group received a 10mg/mL posterior subtenon injection of nanoparticle carboplatin in the eye to be enucleated .
-METHODS	Two eyes were enucleated 6 , 24 and 72 hours post injection .
-METHODS	Intravenous blood was collected during enucleation .
-METHODS	The concentration of carboplatin reaching various intraocular tissues was determined by inductively coupled plasma atomic emission spectroscopy .
-METHODS	The drug toxicity in the ocular tissues was assessed by histopathology and high-resolution transmission electron microscopy .
-RESULTS	The highest level of carboplatin was detected in retinas ( 8.33 1.69 mg/g ) , up to 24 hours post treatment .
-RESULTS	The intravitreal concentration continued to increase gradually until 72 hours ( 3.46 0.26 mg/g ) .
-RESULTS	The choroids and lenses showed very low levels of carboplatin after 6 hours , with negligible amounts at 72 hours .
-RESULTS	No signs of tissue damage were observed on histopathology or electron microscopy .
-RESULTS	Intravenous concentration of carboplatin was undetectable in all patients .
-CONCLUSIONS	Results may indicate an increased facilitated trans-scleral transport of nanoparticle carboplatin , with a sustained-release behavior but without any associated short-term ocular or systemic side effects in humans .
-CONCLUSIONS	The very high concentrations achieved in vitreous and retina after a single posterior subtenon injection may be clinically useful for adjunctive treatment of advanced intraocular retinoblastoma with vitreous seeds .
-CONCLUSIONS	However , further studies are needed to assess long-term toxicity andclinical efficacy .
-
-###25102193
-BACKGROUND	Serial wide-field fluorescein angiography was performed on eyes with preproliferative ( ischemic ) central retinal vein occlusion to evaluate retinal perfusion .
-METHODS	Serial wide-field fluorescein angiography was performed on 12 preproliferative central retinal vein occlusion eyes in the 3-year Rubeosis Anti-VEGF ( RAVE ) trial using the Staurenghi lens ( Ocular Staurenghi 230SLO Retina Lens ) with a scanning laser ophthalmoscope ( Heidelberg HRA Spectralis ) .
-METHODS	`` Disk area '' was defined anatomically for each eye .
-RESULTS	Mean total field of gradable retina was 290 disk areas ( range , 178-452 ) .
-RESULTS	All eyes demonstrated extensive areas of retinal nonperfusion ; at baseline , mean area of retinal perfusion was 106 disk areas ( range , 37-129 ) , correlating with a mean of 46.5 % perfused retinal area ( range , 19.1-56 .4 % ) .
-RESULTS	The area of retinal nonperfusion increased in all eyes with a mean loss of approximately 8.1 % of perfused retinal area per year ( range , 4.3-12 .4 % ) , which corresponded to a mean 15-disk areas ( range , 12-35 ) of retina evolving from perfused to nonperfused annually .
-RESULTS	The extent of baseline and final nonperfusion was not significantly different between eyes that developed neovascularization and eyes that did not .
-CONCLUSIONS	In this population of severe central retinal vein occlusion eyes , profound retinal nonperfusion was observed with wide-field fluorescein angiography at baseline and the extent of nonperfusion progressed while undergoing anti-vascular endothelial growth factor therapy .
-
-###25115430
-OBJECTIVE	To evaluate effects of preoperative high-dose glucocorticoid on the inflammatory response and recovery after endovascular aortic aneurysm repair ( EVAR ) .
-BACKGROUND	The postimplantation syndrome after EVAR may delay recovery due to the release of proinflammatory mediators .
-BACKGROUND	Glucocorticoids may reduce postoperative inflammatory responses and enhance recovery , but with limited information on EVAR .
-METHODS	A single-center , randomized , double-blind , placebo-controlled trial of 153 patients undergoing elective EVAR between November 2009 and January 2013 .
-METHODS	Patients received 30 mg/kg of methylprednisolone ( MP ) ( n = 77 ) or placebo ( n = 76 ) preoperatively .
-METHODS	Primary outcome was a modified version of the systemic inflammatory response syndrome .
-METHODS	Secondary outcome measures were the effect on inflammatory biomarkers , morbidity , and time to meet discharge criteria .
-RESULTS	Of 153 randomized patients , 150 ( 98 % ) were evaluated for the primary outcome .
-RESULTS	MP reduced systemic inflammatory response syndrome from 92 % to 27 % ( P < 0.0001 ) ( number needed to treat = 1.5 ) , maximal plasma interleukin 6 from 186 pg/mL [ interquartile range ( IQR ) = 113-261 pg/mL ] to 20 pg/mL ( IQR = 11-28 pg/mL ) ( P < 0.001 ) and fulfillment of discharge criteria was shorter [ 2 days ( IQR = 2-4 days ) vs 3 days ( IQR = 3-4 days ) ] ( P < 0.001 ) .
-RESULTS	C-reactive protein , temperature , interleukin 8 , and soluble tumor necrosis factor receptor were also reduced ( P < 0.001 ) by MP .
-RESULTS	Myeloperoxidase , D-dimer , and matrix metalloproteinase 9 were not modified .
-RESULTS	No differences in 30-day medical ( 23 % vs 36 % ) ( P = 0.1 ) or surgical ( 20 % vs 21 % ) morbidity were found in the active group versus the placebo group .
-CONCLUSIONS	Preoperative MP attenuates the inflammatory response with a faster recovery after EVAR for abdominal aortic aneurysms .
-CONCLUSIONS	Further safety and dose-response studies are required to allow recommendations for general practice .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00989729 .
-
-###24335026
-OBJECTIVE	The present study tested the hypothesis that pretreatment with metformin decreases postprocedural myocardial injury and improves clinical outcomes in metabolic syndrome patients following percutaneous coronary intervention ( PCI ) .
-METHODS	We enrolled 152 metabolic syndrome patients with no prior history of metformin treatment .
-METHODS	Patients scheduled for elective coronary intervention were randomized to the metformin or control group 7 days before the procedure .
-METHODS	Creatine kinase-MB ( CK-MB ) and troponin I levels were measured at baseline and 8 and 24 h after the procedure , and clinical outcomes were monitored for 1 year .
-RESULTS	Post-PCI myocardial injury as indicated by CK-MB elevation ( 14.5 vs. 32.9 % , p = 0.008 ) and troponin I elevation ( 14.5 vs. 34.2 % , p = 0.005 ) was significantly lower in the metformin group than in the control group .
-RESULTS	Postprocedural peak values of CK-MB ( 2.70 4.30 vs. 6.29 8.03 ng/ml , p < 0.001 ) and troponin I ( 0.02 0.05 vs. 0.07 0.10 ng/ml , p = 0.001 ) were also significantly lower in the metformin group than in the control group .
-RESULTS	At 1 year , the composite endpoint of death from any cause , post-PCI myocardial infarction ( MI ) , MI after PCI hospitalization or ischemia-driven target lesion revascularization occurred in 7.9 % of metformin-treated patients and 28.9 % of controls ( hazard ratio 0.25 , 95 % CI 0.10-0 .62 , log rank p = 0.001 ) .
-CONCLUSIONS	A 7-day metformin pretreatment regimen ( 250 mg 3 times a day ) significantly reduces postprocedural myocardial injury and improves 1-year clinical outcomes in metabolic syndrome patients undergoing PCI .
-
-###24720396
-OBJECTIVE	To evaluate tooth position after six and 9 months of orthodontics with conventional brackets on one side of the dentition and ligature-less brackets on the other .
-METHODS	Orthodontic Division , Vienna Medical University .
-METHODS	Twenty patients aged 22.5 5.7 years , symmetrical malocclusion and arch form , no premolar extraction .
-METHODS	Prospective split-mouth study , 0.022-inch SmartClip self-ligating brackets assigned randomly to the left or right dentition , conventional 0.018-inch brackets on the other side .
-METHODS	52 dental landmarks , digitized on plaster casts , represented dental arches at baseline ( t0 ) , 6 months and 9 months ( t1 , t2 ) .
-METHODS	During t0-t1 , we used 0.016 and 0.014 x 0.025 inch superelastic wires , during t1-t2 connected reverse-curve hemiarch wires : 0.017 x 0.025 inch - titanium on the ligature-less side , and 0.016 x 0.022 inch Elgiloy multiloop wires on conventional brackets .
-METHODS	Morphometric analyses were used to assess differences in dental arch shapes .
-RESULTS	Neither initial alignment nor the reverse-curve phase showed statistically significant differences between ligature-less and conventional brackets in moving teeth .
-CONCLUSIONS	Morphometric shape analyses corroborated current evidence that self-ligating brackets were no more effective than conventional brackets with steel ligatures after 6-month initial alignment .
-CONCLUSIONS	From months 6-9 treatment with - titanium reverse-curve wires on 0.022-inch ligature-less brackets resulted in similar tooth positions as accomplished by Elgiloy multiloop wires on 0.018-inch steel-ligature-tied brackets .
-
-###24650832
-OBJECTIVE	To examine the effect of cognitive-behavioral therapy for insomnia ( CBTI ) on sleep improvement , daytime symptoms , and quality of life ( QOL ) in breast cancer survivors ( BCSs ) after cancer treatment .
-METHODS	A prospective , longitudinal , randomized , controlled trial .
-METHODS	Oncology clinics , breast cancer support groups , and communities in Colorado .
-METHODS	56 middle-aged BCSs with chronic insomnia .
-METHODS	Women were randomly assigned to CBTI or behavioral placebo treatment ( BPT ) and completed measures of sleep , QOL , functioning , fatigue , and mood at baseline , postintervention , and at three - and six-month follow-ups .
-METHODS	Sleep outcomes ( e.g. , sleep efficiency , sleep latency , total sleep time , wake after sleep onset , number of nightly awakenings ) ; secondary variables included sleep medication use , insomnia severity , QOL , physical function , cognitive function , fatigue , depression , anxiety , and sleep attitudes or knowledge .
-RESULTS	Sleep efficiency and latency improved more in the CBTI group than the BPT group ; this difference was maintained during follow-up .
-RESULTS	Women in the CBTI group had less subjective insomnia , greater improvements in physical and cognitive functioning , positive sleep attitudes , and increased sleep hygiene knowledge .
-RESULTS	No group differences in improvement were noted relative to QOL , fatigue , or mood .
-CONCLUSIONS	Nurse-delivered CBTI appears to be beneficial for BCSs ' sleep latency/efficiency , insomnia severity , functioning , sleep knowledge , and attitudes more than active placebo , with sustained benefit over time .
-CONCLUSIONS	Oncology nurses are in a unique position to identify insomnia in cancer survivors .
-CONCLUSIONS	When sleep disturbances become chronic , nurses need to make recommendations and referrals .
-
-###24432677
-OBJECTIVE	To observe changes of brain glucose metabolism by needling at Waiguan ( SJ5 ) in cerebral infraction ( CI ) patients using 18F-fluorodeoxyglucose ( FDG ) positron-emission computer tomography ( PET/CT ) , thus exploring its effect and mechanisms .
-METHODS	A total of 21 patients with CI were recruited in this study .
-METHODS	The location of lesion was limited to the left basal ganglia by CT or MRI scan .
-METHODS	All patients were randomly assigned to three groups .
-METHODS	i.e. , the acupoint group ( Group A ) , the non-acupoint group ( Group B ) , the blank control group ( Group C ) , 7 in each group .
-METHODS	Patients in Group A were needled at right Waiguan ( SJ5 ) .
-METHODS	Those in Group B were needled at non-acupoint [ 10 mm beside Waiguan ( SJ5 ) ] , whereas those in Group C did not receive any treatment .
-METHODS	All patients underwent PET/CT head scan .
-METHODS	All data were statistically analyzed using SPSS 13.0 Software and SPM8 Software .
-RESULTS	Compared with Group C , glucose metabolism increased in bilateral superior temporal gyrus ( BA38 ) , right superior frontal gyrus ( BA9 ) , left cingulate gyrus ( BA24 ) , left culmen and pyramid of cerebellum , and right cerebellar tonsil of cerebellum in Group A. Compared with Group C , glucose metabolism increased in bilateral superior frontal gyrus ( BA6 , BA9 , BA10 ) , bilateral middle frontal gyrus ( BA6 , BA10 ) , left middle frontal gyrus ( BA4 ) , bilateral uncus of limbic lobe ( BA36 , BA38 ) , left cingulate gyrus ( BA24 , BA31 ) , left posterior cingulate gyrus ( BA30 ) , left precuneus ( BA7 ) , left inferior parietal lobule ( BA4 ) , and left lingual gyrus of occipital lobe ( BA18 ) in Group B. Compared with Group B , glucose metabolism increased in bilateral superior temporal gyrus ( BA22 , BA38 ) , right inferior frontal gyrus ( BA47 ) , left culmen and cerebellar tonsil of cerebellum in Group A. Activated encephalic regions of needling at Waiguan ( SJ5 ) were mainly dominated in the healthy side , bilateral superior temporal gyrus , and right inferior frontal gyrus .
-RESULTS	Activated encephalic regions of cerebellum were located at the left cerebellar hemisphere , left culmen of anterior cerebella lobe , and bilateral cerebellar tonsil of posterior cerebella lobe .
-CONCLUSIONS	Needling at Waiguan ( SJ5 ) of CI patients induced increased glucose metabolism in local cerebral regions .
-CONCLUSIONS	Functional neuroimaging using PET/CT could directly reflect changes of brain glucose metabolism by acupuncture .
-
-###24409833
-BACKGROUND	Asians are prone to develop epidermal pigmentary lesions as a result of photoaging .
-BACKGROUND	Solar lentigines , especially those which are light in color , show somewhat limited response to pigment lasers and intense pulsed light sources .
-OBJECTIVE	We sought to compare the early effects as well as side effects of Q-switched Nd : YAG and Er : YAG micropeel in treating light solar lentigines in Asians .
-METHODS	This was a split-face , evaluator-blind , randomized controlled study .
-METHODS	A single session of treatment was performed on Asian patients with light facial lentigines .
-METHODS	Q-switched Nd : YAG laser was allocated to one half of the face , and Er : YAG micropeel to the other half .
-METHODS	The response to therapy was evaluated by two independent dermatologists with standardized photographs taken 2 weeks and 1 month after the laser treatment .
-METHODS	Patients ' satisfaction and preference in treatment were also assessed .
-RESULTS	Fifteen patients completed the study and were analyzed .
-RESULTS	A reduction in pigment was observed with both lasers during the study period .
-RESULTS	The degree of pigment reduction in the Q-switched Nd : YAG treated side of the face was significantly higher than that of the Er : YAG micropeel treated side at 2-week follow-up ( p < 0.001 ) .
-RESULTS	The degree of pigment reduction between the Q-switched Nd : YAG-treated side and the Er : YAG micropeel-treated side was similar at 1-month follow-up ( p = 0.110 ) .
-CONCLUSIONS	While there is no perfect therapy for light solar lentigines , a single session of Q-switched Nd : YAG laser and Er : YAG micropeel was shown to reduce pigmentation .
-CONCLUSIONS	The immediate effects ( 2-week follow-up ) were better with the Q-switched Nd : YAG laser but there was no great difference between the two laser types at 1-month follow-up due to the greater degree of post-inflammatory hyperpigmentation following Q-switched Nd : YAG .
-CONCLUSIONS	Both laser types could be applied either singly in turns , or in combination for maximal efficacy in future .
-
-###25212703
-OBJECTIVE	Daclizumab is a humanized monoclonal antibody that blocks the - subunit of the interleukin-2 receptor with demonstrated benefits in the treatment of multiple sclerosis .
-OBJECTIVE	The present work aimed to characterize the pharmacokinetics of daclizumab high-yield process ( HYP ) in healthy volunteers .
-METHODS	Three double-blind , randomized , placebo-controlled , phaseI studies evaluated the pharmacokinetics of daclizumab HYP in healthy volunteers following single subcutaneous administration ( 50 , 150 , or 300mg ) , multiple subcutaneous administrations ( 100 or 200mg biweekly with a 200mg loading dose ) , or single intravenous administration ( 200 or 400mg ) .
-METHODS	Measurable serum concentrations ( n = 925 ) from 70 subjects treated with daclizumab HYP in the three studies were analyzed using non-linear mixed-effects modeling .
-RESULTS	A two-compartment model with a first-order absorption and elimination adequately described daclizumab HYP pharmacokinetics .
-RESULTS	Daclizumab HYP clearance , inter-compartmental clearance , and central and peripheral volumes of distribution were 10mL/h , 44mL/h , 3.89 L , and 2.52 L , respectively , scaled by [ bodyweight ( kg ) / 70 ] with 0.54 and 0.64 exponents for clearance and volume parameters , respectively .
-RESULTS	Lag-time , mean absorption time , and absolute bioavailability ( 100-300mg ) for subcutaneous administration were 2h , 4.6 days , and 84 % , respectively .
-RESULTS	Bodyweight explained only ~ 20 % of daclizumab HYP pharmacokinetic variability .
-RESULTS	With this limited dataset , sex , age , race , or presence of antibodies did not correlate with daclizumab HYP clearance .
-RESULTS	The estimated effective half-life was 21-25days .
-RESULTS	The developed model was robust in bootstrap evaluation and predicted the data adequately in stochastic simulations .
-CONCLUSIONS	Daclizumab HYP is characterized by slow clearance , linear pharmacokinetics ( at doses100mg ) , high subcutaneous bioavailability , and a half-life suitable for monthly administration .
-
-###24635770
-BACKGROUND	The Surviving Sepsis Campaign recommends targeting a mean arterial pressure of at least 65 mm Hg during initial resuscitation of patients with septic shock .
-BACKGROUND	However , whether this blood-pressure target is more or less effective than a higher target is unknown .
-METHODS	In a multicenter , open-label trial , we randomly assigned 776 patients with septic shock to undergo resuscitation with a mean arterial pressure target of either 80 to 85 mm Hg ( high-target group ) or 65 to 70 mm Hg ( low-target group ) .
-METHODS	The primary end point was mortality at day 28 .
-RESULTS	At 28 days , there was no significant between-group difference in mortality , with deaths reported in 142 of 388 patients in the high-target group ( 36.6 % ) and 132 of 388 patients in the low-target group ( 34.0 % ) ( hazard ratio in the high-target group , 1.07 ; 95 % confidence interval [ CI ] , 0.84 to 1.38 ; P = 0.57 ) .
-RESULTS	There was also no significant difference in mortality at 90 days , with 170 deaths ( 43.8 % ) and 164 deaths ( 42.3 % ) , respectively ( hazard ratio , 1.04 ; 95 % CI , 0.83 to 1.30 ; P = 0.74 ) .
-RESULTS	The occurrence of serious adverse events did not differ significantly between the two groups ( 74 events [ 19.1 % ] and 69 events [ 17.8 % ] , respectively ; P = 0.64 ) .
-RESULTS	However , the incidence of newly diagnosed atrial fibrillation was higher in the high-target group than in the low-target group .
-RESULTS	Among patients with chronic hypertension , those in the high-target group required less renal-replacement therapy than did those in the low-target group , but such therapy was not associated with a difference in mortality .
-CONCLUSIONS	Targeting a mean arterial pressure of 80 to 85 mm Hg , as compared with 65 to 70 mm Hg , in patients with septic shock undergoing resuscitation did not result in significant differences in mortality at either 28 or 90 days .
-CONCLUSIONS	( Funded by the French Ministry of Health ; SEPSISPAM ClinicalTrials.gov number , NCT01149278 . )
-
-###24937907
-OBJECTIVE	The main aim of the study was to evaluate the effect on subjects ' temperature measurement readings when using the infrared tympanic thermometer after correct earphone placement and use , with or without music transmission through the earphone .
-METHODS	A comparative study design was adopted .
-METHODS	A sample of 39 healthy people was randomly divided into three groups .
-METHODS	Subjects in all groups used an earphone that had been correctly placed in the right ear only : Group 1 : listened to heavy metal music through the earphone ( 13 participants ) ; Group 2 : listened to classical music through the earphone ( 13 participants ) ; Group 3 : no music or sound was transmitted through the earphone ( 13 participants ) .
-METHODS	Average differences ( CI 95 % ) and Pearson correlations for the temperature measured in the right ear , which was exposed to the different independent variables , and the left ear which was not exposed , were calculated at different times : ( 1 ) after 10 minutes compared to the baseline measurement ; ( 2 ) after 30 minutes compared to the 10 minutes measurement ; and ( 3 ) after 30 minutes compared to the baseline measurement .
-RESULTS	The inter-ear temperature correlation at the baseline was Pearson r .801 ( p = .01 ) .
-RESULTS	There was a significant decrease in the correlations between right and left ear temperatures in Group 1 and in Group 3 which was demonstrated after 10 minutes of earphone use , and reached critical values after 30 minutes of use in all groups .
-RESULTS	The average warmth in the right ear , as perceived by participants after 20 minutes , was reported .
-RESULTS	Using the Numerical Rating Score the average was 3.3 + / - 1.3 for Group 1 , for Group 2 was 1.9 + / - 1.3 and for Group 3 was 3.3 + / - 1.2 ( p = .05 ) .
-CONCLUSIONS	Within the limitations of the study , which involved a limited number of healthy people the results show that it is best to not measure tympanic temperature in an ear that has very recently had an earphone in place .
-
-###26171933
-BACKGROUND	The aim of this study was to assess the efficacy of neoadjuvant anastrozole and fulvestrant treatment of large operable or locally advanced hormone-receptor-positive breast cancer not eligible for initial breast-conserving surgery , and to identify genomic changes occurring after treatment .
-METHODS	One hundred and twenty post-menopausal patients were randomised to receive 1mg anastrozole ( 61 patients ) or 500mg fulvestrant ( 59 patients ) for 6 months .
-METHODS	Genomic DNA copy number profiles were generated for a subgroup of 20 patients before and after treatment .
-RESULTS	A total of 108 patients were evaluable for efficacy and 118 for toxicity .
-RESULTS	The objective response rate determined by clinical palpation was 58.9 % ( 95 % CI = 45.0-71 .9 ) in the anastrozole arm and 53.8 % ( 95 % CI = 39.5-67 .8 ) in the fulvestrant arm .
-RESULTS	The breast-conserving surgery rate was 58.9 % ( 95 % CI = 45.0-71 .9 ) in the anastrozole arm and 50.0 % ( 95 % CI = 35.8-64 .2 ) in the fulvestrant arm .
-RESULTS	Pathological responses > 50 % occurred in 24 patients ( 42.9 % ) in the anastrozole arm and 13 ( 25.0 % ) in the fulvestrant arm .
-RESULTS	The Ki-67 score fell after treatment but there was no significant difference between the reduction in the two arms ( anastrozole 16.7 % ( 95 % CI = 13.3-21 .0 ) before , 3.2 % ( 95 % CI = 1.9-5 .5 ) after , n = 43 ; fulvestrant 17.1 % ( 95 % CI = 13.1-22 .5 ) before , 3.2 % ( 95 % CI = 1.8-5 .7 ) after , n = 38 ) or between the reduction in Ki-67 in clinical responders and non-responders .
-RESULTS	Genomic analysis appeared to show a reduction of clonal diversity following treatment with selection of some clones with simpler copy number profiles .
-CONCLUSIONS	Both anastrozole and fulvestrant were effective and well-tolerated , enabling breast-conserving surgery in over 50 % of patients .
-CONCLUSIONS	Clonal changes consistent with clonal selection by the treatment were seen in a subgroup of patients .
-
-###25200170
-BACKGROUND	The purpose of the present study is to evaluate the impact of a health psychology-led bariatric rehabilitation service ( BRS ) on patient weight loss following bariatric surgery at 1 year .
-METHODS	A single-site open-randomised parallel group control trial based at St. Richard 's Hospital in Chichester in the UK .
-METHODS	Patients ( n = 162 ) were recruited immediately prior to Roux-en-Y gastric bypass and randomly allocated to receive either treatment as usual ( n = 80 ) or the BRS ( n = 82 ) .
-METHODS	The BRS involved three 50-min one-to-one sessions with a health psychologist and provided information , support and mentoring pre and post surgery addressing psychological issues such as dietary control , self esteem , coping and emotional eating .
-METHODS	Weight loss was assessed at 1 year .
-METHODS	The key outcome variable was BMI and change in BMI .
-RESULTS	Follow-up weight was available for 145 patients .
-RESULTS	Intention-to-treat analysis ( n = 162 ) using last measured weights showed that mean change in BMI by 1 year post surgery was -16.49 .
-RESULTS	There was no significant difference between the two groups ( control group = -16.37 , 95 % CI = 15.15-17 .57 ; intervention = -16.6 , 95 % CI = 15.42-17 .81 ; p ( 2 ) = 0.001 ) .
-RESULTS	Similarly , explanatory analysis ( n = 145 ) showed a mean change in BMI of -17.17 .
-RESULTS	The difference between the two groups was not significant ( control group = -16.9 , 95 % CI = 15.78-18 .18 ; intervention = -17.35 , 95 % CI = 18.5-16 .16 ; p ( 2 ) = 0.001 ) .
-CONCLUSIONS	Psychological support pre and post bariatric surgery had no impact on weight loss as measured by BMI and change in BMI by 1 year .
-CONCLUSIONS	It is argued that psychological support should be targeted to patients who start to demonstrate weight regain at a later stage .
-BACKGROUND	ClinicalTrials.gov NCT01264120 .
-
-###24257456
-BACKGROUND	The Orsiro Hybrid sirolimus-eluting stent is a newly developed third-generation drug-eluting stent , featuring a unique dual-polymer mix .
-BACKGROUND	An active bioabsorbable polymer delivers the anti-proliferative drug , sirolimus , via controlled release , while a passive biocompatible polymeric coating shields the metallic strut from surrounding tissue , preventing interaction .
-BACKGROUND	To date , the Orsiro Hybrid sirolimus-eluting stent has excelled in terms of late lumen loss at 9 months in a first-in-man single-arm trial .
-BACKGROUND	However , the efficacy and safety data for Orsiro Hybrid sirolimus-eluting stents in a broader population of all-comers are limited .
-BACKGROUND	The present study offers an angiographic and clinical comparison of the Orsiro Hybrid sirolimus-eluting stent and the Resolute Integrity zotarolimus-eluting stent in the treatment of patients with coronary artery disease .
-METHODS	The ORIENT trial is a multicenter , randomized , open-label , parallel-arm study designed to demonstrate the non-inferiority of the Orsiro Hybrid sirolimus-eluting stent relative to the Resolute Integrity zotarolimus-eluting stent .
-METHODS	A total of 375 patients with a spectrum of coronary artery disease will undergo prospective , random assignment to a Orsiro Hybrid sirolimus-eluting stent or Resolute Integrity zotarolimus-eluting stent ( 2:1 ratio ) , for a primary endpoint of in-stent late lumen loss at 9 months by quantitative coronary angiography .
-METHODS	Secondary 12-month clinical endpoints are death , target lesion revascularization , target vessel revascularization , myocardial infarction , stent thrombosis and target lesion failure ( a composite of cardiac death , target lesion revascularization and target vessel-related myocardial infarction ) .
-CONCLUSIONS	The ORIENT trial is the first study to date comparing the Orsiro Hybrid sirolimus-eluting stent with the Resolute Integrity zotarolimus-eluting stent for efficacy and safety in a population of all-comers with coronary artery disease .
-BACKGROUND	Clinicaltrials.gov NCT01826552 .
-
-###25908066
-BACKGROUND	Patients receiving oral anticoagulation ( OAC ) who undergo drug-eluting stent ( DES ) implantation require additional dual antiplatelet therapy with aspirin and clopidogrel .
-BACKGROUND	Such triple therapy confers an elevated bleeding risk , and its optimal duration is not known .
-OBJECTIVE	The goal of this study was to evaluate whether shortening the duration of clopidogrel therapy from 6 months to 6 weeks after DES implantation was associated with a superior net clinical outcome in patients receiving concomitant aspirin and OAC .
-METHODS	In this randomized , open-label trial , we enrolled patients receiving OAC who underwent DES implantation at 3 European centers between September 2008 and December 2013 .
-METHODS	A total of 614 patients receiving concomitant aspirin and OAC were randomized to either 6-week clopidogrel therapy ( n = 307 ) or 6-month clopidogrel therapy ( n = 307 ) .
-METHODS	The primary endpoint was a composite of death , myocardial infarction ( MI ) , definite stent thrombosis , stroke , or Thrombolysis In Myocardial Infarction ( TIMI ) major bleeding at 9 months .
-RESULTS	The primary endpoint occurred in 30 patients ( 9.8 % ) in the 6-week group compared with 27 patients ( 8.8 % ) in the 6-month group ( hazard ratio [ HR ] : 1.14 ; 95 % CI : 0.68 to 1.91 ; p = 0.63 ) .
-RESULTS	There were no significant differences for the secondary combined ischemic endpoint of cardiac death , MI , definite stent thrombosis , and ischemic stroke ( 12 [ 4.0 % ] vs. 13 [ 4.3 % ] ; HR : 0.93 ; 95 % CI : 0.43 to 2.05 ; p = 0.87 ) or the secondary bleeding endpoint of TIMI major bleeding ( 16 [ 5.3 % ] vs. 12 [ 4.0 % ] ; HR : 1.35 ; 95 % CI : 0.64 to 2.84 ; p = 0.44 ) .
-CONCLUSIONS	Six weeks of triple therapy was not superior to 6 months with respect to net clinical outcomes .
-CONCLUSIONS	These results suggest that physicians should weigh the trade-off between ischemic and bleeding risk when choosing the shorter or longer duration of triple therapy .
-CONCLUSIONS	( Triple Therapy in Patients on Oral Anticoagulation After Drug Eluting Stent Implantation [ ISAR-TRIPLE ] ; NCT00776633 ) .
-
-###26039600
-BACKGROUND	The Veterans Affairs Diabetes Trial previously showed that intensive glucose lowering , as compared with standard therapy , did not significantly reduce the rate of major cardiovascular events among 1791 military veterans ( median follow-up , 5.6 years ) .
-BACKGROUND	We report the extended follow-up of the study participants .
-METHODS	After the conclusion of the clinical trial , we followed participants , using central databases to identify procedures , hospitalizations , and deaths ( complete cohort , with follow-up data for 92.4 % of participants ) .
-METHODS	Most participants agreed to additional data collection by means of annual surveys and periodic chart reviews ( survey cohort , with 77.7 % follow-up ) .
-METHODS	The primary outcome was the time to the first major cardiovascular event ( heart attack , stroke , new or worsening congestive heart failure , amputation for ischemic gangrene , or cardiovascular-related death ) .
-METHODS	Secondary outcomes were cardiovascular mortality and all-cause mortality .
-RESULTS	The difference in glycated hemoglobin levels between the intensive-therapy group and the standard-therapy group averaged 1.5 percentage points during the trial ( median level , 6.9 % vs. 8.4 % ) and declined to 0.2 to 0.3 percentage points by 3 years after the trial ended .
-RESULTS	Over a median follow-up of 9.8 years , the intensive-therapy group had a significantly lower risk of the primary outcome than did the standard-therapy group ( hazard ratio , 0.83 ; 95 % confidence interval [ CI ] , 0.70 to 0.99 ; P = 0.04 ) , with an absolute reduction in risk of 8.6 major cardiovascular events per 1000 person-years , but did not have reduced cardiovascular mortality ( hazard ratio , 0.88 ; 95 % CI , 0.64 to 1.20 ; P = 0.42 ) .
-RESULTS	No reduction in total mortality was evident ( hazard ratio in the intensive-therapy group , 1.05 ; 95 % CI , 0.89 to 1.25 ; P = 0.54 ; median follow-up , 11.8 years ) .
-CONCLUSIONS	After nearly 10 years of follow-up , patients with type 2 diabetes who had been randomly assigned to intensive glucose control for 5.6 years had 8.6 fewer major cardiovascular events per 1000 person-years than those assigned to standard therapy , but no improvement was seen in the rate of overall survival .
-CONCLUSIONS	( Funded by the VA Cooperative Studies Program and others ; VADT ClinicalTrials.gov number , NCT00032487 . )
-
-###25221851
-OBJECTIVE	To determine inter - and intra-tester reliability of strength measurements during maximal electrically induced contractions ( MEIC ) using a hand-held dynamometer ( HHD ) .
-METHODS	Thirty-seven healthy young female adults , mean age ( SD ) 23.4 ( 2.4 ) years , were tested by two examiners during two sessions , with order of examiners randomized .
-METHODS	Biphasic pulses ( phase duration -- 300s ; pulse frequency -- 75Hz ) were employed in order to induce contractions of the quadriceps femoris muscle at a maximally tolerated current level .
-METHODS	Strength of maximal voluntary isometric contractions ( MVIC ) and of MEIC was recorded with a HHD utilizing a stabilization belt .
-RESULTS	Good to excellent inter - and intra-tester reliability were determined with intra-class correlation coefficients ranging between 0.8 and 0.9 , and no bias in the Bland-Altman plots .
-RESULTS	The 95 % repeatability ranged between 8.7 and 13.0 kg for the MVIC and MEIC , and between 20.7 and 25.6 % for the % MVIC .
-CONCLUSIONS	Our results confirm previous findings indicating good to excellent reliability of quadriceps femoris muscle MVIC assessment with a HHD .
-CONCLUSIONS	However , a high 95 % repeatability range indicates the HHD is not sufficiently reliable as an indicator of the force level attained during electrically induced contractions .
-CONCLUSIONS	Other methods need to be investigated to assist in determining whether MEIC have reached therapeutic levels .
-
-###24225740
-OBJECTIVE	To compare the effects of a 3-week supplementation between two different mixtures of antioxidants and placebo on aerobic exercise performance in acute normobaric hypoxia .
-METHODS	Seventeen subjects were randomly assigned in a double-blind fashion to receive a broad-based antioxidants supplement containing beta-carotene , ascorbic acid , d-alpha-tocopherol-succinate , N-acetylcysteine , riboflavin , zinc , and selenium ( antioxidant capsule group [ AO group ] ) , or a combination of alpha-ketoglutaric acid ( - KG ) and 5-hydroxymethylfurfural ( 5-HMF ; CYL concentrate supplementation group [ CS group ] ) , or placebo ( PL group ) .
-METHODS	Before and after supplementation , subjects performed two incremental cycle-exercise tests until exhaustion .
-METHODS	The first test was conducted under normoxic conditions ( LA , FiO2 of 20.9 % , ~ 547 m ) and the second after the 3-week supplementation period under normobaric hypoxic conditions ( AHA , FiO2 of 12.9 % , ~ 4300m ) .
-RESULTS	In CS peak cycling performance ( peak power ) declined from LA to AHA 7.3 % ( 90 % CI : 2.2-12 .4 ) less compared with PL ( p = .04 ) and 6.7 % ( 90 % CI : 3.2-10 .2 ) less compared with AO ( p = .03 ) .
-RESULTS	Better maintenance of aerobic exercise capacity in CS was associated with an attenuated reduction in maximal heart rate in hypoxia .
-CONCLUSIONS	Aerobic exercise performance was less impaired in acute normobaric hypoxia after 3 weeks with supplementation of - KG and 5-HMF compared with a broad-based antioxidants supplement or PL .
-
-###25470228
-OBJECTIVE	Previous reports of the RAPID-axSpA trial ( NCT01087762 ) described the efficacy and safety of certolizumab pegol ( CZP ) over 24 weeks in patients with axial spondyloarthritis ( SpA ) , including ankylosing spondylitis ( AS ) and nonradiographic axial SpA .
-OBJECTIVE	We report efficacy and safety data up to week 96 of the study .
-METHODS	The RAPID-axSpA trial is double-blind and placebo-controlled to week 24 , dose-blind to week 48 , and open-label to week 204 .
-METHODS	Outcome variables included Assessment of SpondyloArthritis international Society criteria for 20 % and 40 % improvement in disease activity ( ASAS20/40 ) , ASAS partial remission responses ( analyzed by nonresponder imputation ) , AS Disease Activity Score ( ASDAS ) , ASDAS inactive disease , ASDAS major improvement , Bath AS Disease Activity Index ( BASDAI ) , Bath AS Functional Index ( BASFI ) , and Bath AS Metrology Index ( BASMI ) linear score ( analyzed by the last observation carried forward method ) .
-METHODS	Safety data were collected for patients treated with 1 dose of CZP .
-RESULTS	Of the 325 patients who were randomized , 218 received CZP from week 0 .
-RESULTS	Of these , 93 % completed week 24 , 88 % completed week 48 , and 80 % completed week 96 .
-RESULTS	Improvements in ASAS responses were maintained to week 96 ( for ASAS20 , 67.4 % , 72.0 % , and 62.8 % at weeks 24 , 48 , and 96 , respectively ) , as well as improvements in ASDAS , BASDAI ( mean score 3.3 , 3.1 , and 3.0 at weeks 24 , 48 , and 96 , respectively ) , BASFI , and BASMI linear score .
-RESULTS	Comparable improvements were observed with both dosing regimens ( 200 mg every 2 weeks or 400 mg every 4 weeks ) and in patients with AS and those with nonradiographic axial SpA .
-RESULTS	In the safety set , adverse events occurred in 279 patients ( 88.6 % ) and serious adverse events in 41 ( 13.0 % ) .
-RESULTS	No deaths or malignancies were reported .
-CONCLUSIONS	Clinical improvements to week 24 in both CZP dosing regimens were sustained to week 96 .
-CONCLUSIONS	Similar sustained improvements were observed in AS and nonradiographic axial SpA subpopulations .
-CONCLUSIONS	The safety profile was consistent with previous reports from RAPID-axSpA , with no new safety signals observed with longer exposure .
-
-###25301457
-BACKGROUND	Transradial access ( TRA ) has been associated with reduced access site-related bleeding complications and mortality after percutaneous coronary intervention ( PCI ) .
-BACKGROUND	It is unclear , however , whether these observed benefits are influenced by baseline bleeding risk .
-OBJECTIVE	This study investigated the relationship between baseline bleeding risk , TRA utilization , and procedure-related outcomes in patients undergoing PCI enrolled in the British Cardiovascular Intervention Society database .
-METHODS	Baseline bleeding risk was calculated by using modified Mehran bleeding risk scores in 348,689 PCI procedures performed between 2006 and 2011 .
-METHODS	Four categories for bleeding risk were defined for the modified Mehran risk score ( MMRS ) : low ( < 10 ) , moderate ( 10 to 14 ) , high ( 15 to 19 ) , and very high ( 20 ) .
-METHODS	The impact of baseline bleeding risk on 30-day mortality and its relationship with access site were studied .
-RESULTS	TRA was independently associated with a 35 % reduction in 30-day mortality risk ( odds ratio [ OR ] : 0.65 [ 95 % confidence interval ( CI ) : 0.59 to 0.72 ] ; p < 0.0001 ) , with the magnitude of mortality reduction related to baseline bleeding risk ( MMRS < 10 , OR : 0.73 [ 95 % CI : 0.62 to 0.86 ] ; MMRS 20 , OR : 0.53 [ 95 % CI : 0.47 to 0.61 ] ) .
-RESULTS	In patients with an MMRS < 10 , TRA was used in 71,771 ( 43.2 % ) of 166,083 PCI procedures ; TRA was used in 8,655 ( 40.1 % ) of 21,559 PCI procedures in patients with an MMRS 20 , illustrating that TRA was used less in those at highest risk from bleeding complications ( p < 0.0001 ) .
-CONCLUSIONS	TRA was independently associated with reduced 30-day mortality , and the magnitude of this effect was related to baseline bleeding risk ; those at highest risk of bleeding complications gained the greatest benefit from adoption of TRA during PCI .
-
-###25189222
-BACKGROUND	Patients with severe acute exacerbations of asthma often receive inappropriate antibiotic treatment .
-BACKGROUND	We aimed to determine whether serum procalcitonin ( PCT ) levels can effectively and safely reduce antibiotic exposure in patients experiencing exacerbations of asthma .
-METHODS	In this randomized controlled trial , a total of 216 patients requiring hospitalization for severe acute exacerbations of asthma were screened for eligibility to participate and 169 completed the 12-month follow-up visit .
-METHODS	Patients were randomized to either PCT-guided ( PCT group ) or standard ( control group ) antimicrobial therapy .
-METHODS	In the control group , patients received antibiotics according to the attending physician 's discretion ; in the PCT group , patients received antibiotics according to an algorithm based on serum PCT levels .
-METHODS	The primary end point was antibiotic exposure ; secondary end points were clinical recovery , length of hospital stay , clinical and laboratory parameters , spirometry , number of asthma exacerbations , emergency room visits , hospitalizations and need for corticosteroid use due to asthma .
-RESULTS	PCT guidance reduced antibiotic prescription ( 48.9 % versus 87.8 % , respectively ; P < 0.001 ) and antibiotic exposure ( relative risk , 0.56 ; 95 % confidence interval , 0.44 to 0.70 ; P < 0.001 ) compared to standard therapy .
-RESULTS	There were no significant differences in clinical recovery , length of hospital stay or clinical , laboratory and spirometry outcomes in both groups .
-RESULTS	Number of asthma exacerbations , emergency room visits , hospitalizations and need for corticosteroid use due to asthma were similar during the 12-month follow-up period .
-CONCLUSIONS	A PCT-guided strategy allows antibiotic exposure to be reduced in patients with severe acute exacerbation of asthma without apparent harm .
-BACKGROUND	Chinese Clinical Trial Register ChiCTR-TRC-12002534 ( registered 26 September 2012 ) .
-
-###25458910
-BACKGROUND	Respiratory syncytial virus ( RSV ) bronchiolitis in infancy is a major risk factor for recurrent wheezing and asthma .
-BACKGROUND	Because azithromycin attenuated neutrophilic airway inflammation in a murine viral bronchiolitis model , demonstration of similar effects in human subjects might provide a strategy for the prevention of postbronchiolitis recurrent wheezing .
-OBJECTIVE	We sought to investigate whether azithromycin treatment during RSV bronchiolitis reduces serum and nasal lavage IL-8 levels and the occurrence of postbronchiolitis recurrent wheezing .
-METHODS	We performed a randomized , double-masked , placebo-controlled proof-of-concept trial in 40 otherwise healthy infants hospitalized with RSV bronchiolitis who were treated with azithromycin or placebo for 14 days .
-METHODS	IL-8 levels were measured in nasal lavage fluid and serum on randomization , day 8 , and day 15 ( nasal lavage only ) .
-METHODS	The occurrence of wheezing episodes was assessed monthly over the ensuing 50 weeks .
-RESULTS	Compared with placebo , azithromycin treatment did not reduce serum IL-8 levels at day 8 ( P = .6 ) but resulted in a greater decrease in nasal lavage fluid IL-8 levels by day 15 ( P = .03 ) .
-RESULTS	Twenty-two percent of azithromycin-treated participants experienced at least 3 wheezing episodes compared with 50 % of participants in the placebo group ( P = .07 ) .
-RESULTS	Azithromycin treatment resulted in prolonged time to the third wheezing episode ( P = .048 ) and in fewer days with respiratory symptoms over the subsequent year in comparison with placebo ( 36.7 vs 70.1 days , P = .01 ) .
-CONCLUSIONS	In this proof-of-concept study azithromycin treatment during RSV bronchiolitis reduced upper airway IL-8 levels , prolonged the time to the third wheezing episode , and reduced overall respiratory morbidity over the subsequent year .
-
-###24687833
-OBJECTIVE	To evaluate panitumumab plus modified fluorouracil , leucovorin , and oxaliplatin ( mFOLFOX6 ) or bevacizumab plus mFOLFOX6 in patients with previously untreated wild-type ( WT ) KRAS exon 2 ( codons 12 and 13 ) metastatic colorectal cancer ( mCRC ) .
-OBJECTIVE	A prespecified secondary objective was to assess treatment effects in an extended RAS analysis that included exons 2 , 3 , and 4 of KRAS and NRAS .
-METHODS	Patients with WT KRAS exon 2 tumors were randomly assigned at a one-to-one ratio to panitumumab plus mFOLFOX6 or bevacizumab plus mFOLFOX6 .
-METHODS	The primary end point was progression-free survival ( PFS ) ; secondary end points included overall survival ( OS ) and safety .
-RESULTS	Of 285 randomly assigned patients , 278 received treatment .
-RESULTS	In the WT KRAS exon 2 intent-to-treat group , PFS was similar between arms ( hazard ratio [ HR ] , 0.87 ; 95 % CI , 0.65 to 1.17 ; P = .353 ) .
-RESULTS	Median OS was 34.2 and 24.3 months in the panitumumab and bevacizumab arms , respectively ( HR , 0.62 ; 95 % CI , 0.44 to 0.89 ; P = .009 ) .
-RESULTS	In the WT RAS subgroup ( WT exons 2 , 3 , and 4 of KRAS and NRAS ) , PFS favored the panitumumab arm ( HR , 0.65 ; 95 % CI , 0.44 to 0.96 ; P = .029 ) .
-RESULTS	Median OS was 41.3 and 28.9 months ( HR , 0.63 ; 95 % CI , 0.39 to 1.02 ; P = .058 ) in the panitumumab and bevacizumab arms , respectively .
-RESULTS	Treatment discontinuation rates because of adverse events were similar between arms .
-CONCLUSIONS	PFS was similar and OS was improved with panitumumab relative to bevacizumab when combined with mFOLFOX6 in patients with WT KRAS exon 2 tumors .
-CONCLUSIONS	Patients with WT RAS tumors seemed to experience more clinical benefit with anti-epidermal growth factor receptor therapy .
-
-###25059121
-BACKGROUND	Although effectiveness of web-based interventions on lifestyle changes are recognized , the potential of such programs on metabolic syndrome has not been explored .
-BACKGROUND	We describe the protocol of a randomized controlled trial that aims to determine the feasibility , acceptability , usability , and effectiveness of interactive technology on lifestyle intervention in a population with metabolic syndrome .
-METHODS	This is a two-arm randomized controlled trial .
-METHODS	The study includes 160 participants ( n = 80 per arm ) who will be recruited via online registration on the study website .
-METHODS	The inclusion criteria are that they should have metabolic syndrome and have access to the Internet .
-METHODS	All participants will receive information on dietary intake and physical activity through the study website .
-METHODS	The intervention group will receive additional resources via the study website including interactive Healthy Heart Profile and calorie restricted diet tailored to the participants .
-METHODS	The primary outcomes are feasibility , acceptability , usability , and the change in metabolic syndrome components .
-METHODS	The secondary outcomes are comparing quality of life , physical activity and food intake among the study arms .
-METHODS	The participants will be followed up to 6 months with data collection scheduled at baseline , 3 and 6 months .
-CONCLUSIONS	There is a need for developing and evaluating web-based interventions that target people with high risk for cardiovascular diseases .
-CONCLUSIONS	This study will therefore make an important contribution to this novel field of research and practice .
-BACKGROUND	IRCT201111198132N1 .
-
-###24829969
-OBJECTIVE	The purpose of this ongoing randomized study was to assess differences in bone level changes and success rates using implants supporting single crowns in the posterior mandible either with platform matched or platform switched abutments .
-METHODS	Patients aged 18 and above , missing at least two teeth in the posterior mandible and with a natural tooth mesial to the most proximal implant site were enrolled .
-METHODS	Randomization followed implant placement .
-METHODS	Definitive restorations were placed after a minimum transgingival healing period of 8 weeks .
-METHODS	Changes in crestal bone level from surgery and loading ( baseline ) to 12-month post-loading were radiographically measured .
-METHODS	Implant survival and success were determined .
-RESULTS	Sixty-eight patients received 74 implants in the platform switching group and 72 in the other one .
-RESULTS	The difference of mean marginal bone level change from surgery to 12 months was significant between groups ( p < 0.004 ) .
-RESULTS	Radiographical mean bone gain or no bone loss from loading was noted for 67.1 % of the platform switching and 49.2 % of the platform matching implants .
-RESULTS	Implant success rates were 97.3 % and 100 % , respectively .
-CONCLUSIONS	Within the same implant system the platform switching concept showed a positive effect on marginal bone levels when compared with restorations with platform matching .
-
-###24245880
-BACKGROUND	Pronounced nasojugal groove ( tear trough deformity ) is one of the landmarks of aging .
-BACKGROUND	Hyaluronic acid filler can be used for attenuating the nasojugal sulcus but irregular lumpness and overcorrection are common adverse reactions .
-OBJECTIVE	We evaluated the effect of Restylane Vital with its specialized injector on volume correction and skin tone of nasojugal groove .
-METHODS	Ten Korean women were enrolled in this study .
-METHODS	Subjects were randomized to be injected a stabilized hyaluronic acid-based gel of nonanimal origin ( NAHSA injector , Restylane Vital , Q-med ) on one side of nasojugal groove , with the other side paired as control .
-METHODS	The treatment was performed in one session .
-METHODS	Outcome assessments included standardized photography , mexameter , and spectrometer for skin tone , global evaluation by blinded investigators , and patients ' self-assessment .
-METHODS	An assessment was made before treatment , immediately after treatment , and 1 , 3 , and 6 months after the treatment .
-RESULTS	All patients reported a high degree of satisfaction .
-RESULTS	Duration of overall effect varied among the patients .
-RESULTS	Correction of the nasojugal groove with a Restylane Vital injector causes minimal tissue trauma and allows exact placement of hyaluronic acid .
-RESULTS	Restylane Vital injector offers more predictable results and a lower incidence of adverse effects than more commonly used techniques .
-CONCLUSIONS	Hyaluronic acid filler intradermal injection with special injector is a safe and effective method for correction of nasojugal groove .
-
-###24796048
-OBJECTIVE	To evaluate the efficacy and safety of acupuncture-moxibustion combined with modified Mojie tablet ( see text ) in the prevention of the recurrence of endometriosis ( EMS ) after laparoscopic surgery .
-METHODS	After laparoscopic surgery , 120 cases of EMS were randomized into an acupuncture-moxibustion group , a western medication group , a Chinese medication group and a combined therapy of acupuncture-moxibustion and Chinese medication group ( combined therapy group ) , 30 cases in each one .
-METHODS	In the acupuncture-moxibustion group , acupuncture was applied at Xuehai ( SP 10 ) , Sanyinjiao ( SP 6 ) and Guanyuan ( CV 4 ) ; the isolated moxibustion with ginger was used at Guanyuan ( CV 4 ) , once a day , twice a week .
-METHODS	In the western medication group , gestrinone was prescribed for oral administration , 2.5 mg , once a day , twice a week .
-METHODS	In the Chinese medication group , the self-prepared Mojie tablet were prescribed for oral administration .
-METHODS	In the combined therapy group , acupuncture , moxibustion and modified Mojie tablet for oral administration were used in combination .
-METHODS	The therapeutic methods were same as the acupuncture-moxibustion group and the Chinese medication group .
-METHODS	Totally , the treatment of 3 months was required .
-METHODS	Separately , before treatment , after treatment , in 3 months after treatment and in 6 months after treatment , EHP-5 score ( endometriosis health profile-5 ) , the abdominal/vaginal ultrasound examination , serum CA125 detection and safety index ( ALT detection ) were compared in patients among 4 groups .
-RESULTS	In 3 and 6 months after treatment , the positive rates of EHP-5 score were 0 % ( 0/30 ) in the combined therapy group and 0 % ( 0/30 ) in the acupuncture-moxibuston group , which were all lower significantly than 13.3 % ( 4/30 ) in the western medication group ( both P < 0.05 ) .
-RESULTS	In follow-up stage of 6 months after treatment , there was no recurrence case in abdominal lviginal ultrasound examination in the combined therapy group , which was lower than 13.3 % ( 4/30 ) in the western medication group ( P < 0.05 ) ; the serum CA125 detection in the combined therapy group did not find any abnormal case , which was lower than 16.7 % ( 5/30 ) in the western medication group ( P < 0.05 ) .
-RESULTS	At the end of treatment session and in the follow-up stage of 3 months after treatment , the abnormal rate of ALT were 20.0 % ( 6/30 ) and 13.3 % ( 4/30 ) in the western medication group , which were higher than those in any of the rest groups ( P < 0.05 ) .
-RESULTS	In the follow-up stage of 6 months after treatment , there were 3 abnormal cases of ALT in the western medication group , but which was not different significantly as compared with the rest groups ( P > 0.05 ) .
-CONCLUSIONS	Acupuncture and moxibustion combined with modified Mojie tablet effectively prevent from the recurrence of EMS after laparoscopic surgery and improve the life quality of the patients .
-CONCLUSIONS	This combined therapy brings less damage on the liver as compared with the western medication of gestrinone and indicates its definite efficacy and safety .
-
-###24403197
-BACKGROUND	Considering the increasing incidence of chronic kidney disease and the increased use of peritoneal dialysis , we wanted to assess whether the multidisciplinary management of patients in peritoneal dialysis might produce improvement in the quality of patients ' lives when compared to management by a routine team of operators .
-METHODS	Our study observed 40 patients on peritoneal dialysis in our Department between 2010 and 2012 .
-METHODS	They were randomly assigned to either group A , the routine team which consisted of a nephrologist and a nurse , or group B , a multidisciplinary team comprising several medical specialists , a nurse , a psychologist and a social worker .
-METHODS	Two tests , KDQOL-SF and MMPI-2 , were administered to both groups .
-RESULTS	In group B , the number of days of hospitalization and day hospital were more than 88 % lower when compared to group A.
-RESULTS	The multidisciplinary team achieved better results with the KDQOL-SF test with regards to both emotional and objective dimensions .
-RESULTS	The Pearson coefficient between the results of the two questionnaires shows how multidisciplinary management can positively influence the perceived well-being of the patient and his or her adherence to treatment .
-CONCLUSIONS	In a multidisciplinary team , each operator , in addition to his or her specific role , also contributes to the achievement of the overall objective , namely of ensuring an optimal quality of life to the patient on peritoneal dialysis thereby allowing these patients to continue their professional and social lives .
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-###25607594
-OBJECTIVE	Changes in pulmonary dynamics following laparotomy are well documented .
-OBJECTIVE	Deep breathing exercises , with or without incentive spirometry , may help counteract postoperative decreased vital capacity ; however , the evidence for the role of incentive spirometry in the prevention of postoperative atelectasis is inconclusive .
-OBJECTIVE	Furthermore , data are scarce regarding the prevention of postoperative atelectasis in sub-Saharan Africa .
-OBJECTIVE	To determine the effect of the use of incentive spirometry on pulmonary function following exploratory laparotomy as measured by forced vital capacity ( FVC ) .
-METHODS	This was a single-center , randomized clinical trial performed at Kamuzu Central Hospital , Lilongwe , Malawi .
-METHODS	Study participants were adult patients who underwent exploratory laparotomy and were randomized into the intervention or control groups ( standard of care ) from February 1 to November 30 , 2013 .
-METHODS	All patients received routine postoperative care , including instructions for deep breathing and early ambulation .
-METHODS	We used bivariate analysis to compare outcomes between the intervention and control groups .
-METHODS	Adult patients who underwent exploratory laparotomy participated in postoperative deep breathing exercises .
-METHODS	Patients in the intervention group received incentive spirometers .
-METHODS	We assessed pulmonary function using a peak flow meter to measure FVC in both groups of patients .
-METHODS	Secondary outcomes , such as hospital length of stay and mortality , were obtained from the medical records .
-RESULTS	A total of 150 patients were randomized ( 75 in each arm ) .
-RESULTS	The median age in the intervention and control groups was 35 years ( interquartile range , 28-53 years ) and 33 years ( interquartile range , 23-46 years ) , respectively .
-RESULTS	Men predominated in both groups , and most patients underwent emergency procedures ( 78.7 % in the intervention group and 84.0 % in the control group ) .
-RESULTS	Mean initial FVC did not differ significantly between the intervention and control groups ( 0.92 and 0.90 L , respectively ; P = .82 [ 95 % CI , 0.52-2 .29 ] ) .
-RESULTS	Although patients in the intervention group tended to have higher final FVC measurements , the change between the first and last measured FVC was not statistically significant ( 0.29 and 0.25 L , respectively ; P = .68 [ 95 % CI , 0.65-1 .95 ] ) .
-RESULTS	Likewise , hospital length of stay did not differ significantly between groups .
-RESULTS	Overall postoperative mortality was 6.0 % , with a higher mortality rate in the control group compared with the intervention group ( 10.7 % and 1.3 % , respectively ; P = .02 [ 95 % CI , 0.01-0 .92 ] ) .
-CONCLUSIONS	Education and provision of incentive spirometry for unmonitored patient use does not result in statistically significant improvement in pulmonary dynamics following laparotomy .
-CONCLUSIONS	We would not recommend the addition of incentive spirometry to the current standard of care in this resource-constrained environment .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01789177 .
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-###24532997
-OBJECTIVE	To assess the effect of armodafinil on task-related prefrontal cortex activation using functional magnetic resonance imaging ( fMRI ) in patients with obstructive sleep apnea ( OSA ) and excessive sleepiness despite continuous positive airway pressure ( CPAP ) therapy .
-METHODS	This 2-week , multicenter , prospective , randomized , double-blind , placebo-controlled , parallel-group study was conducted at five neuroimaging sites and four collaborating clinical study centers in the United States .
-METHODS	Patients were 40 right-handed or ambidextrous men and women aged between 18 and 60 years , with OSA and persistent sleepiness , as determined by multiple sleep latency and Epworth Sleepiness Scale scores , despite effective , stable use of CPAP .
-METHODS	Treatment was randomized ( 1:1 ) to once-daily armodafinil 200 mg or placebo .
-METHODS	The primary efficacy outcome was a change from baseline at week 2 in the volume of activation meeting the predefined threshold in the dorsolateral prefrontal cortex during a 2-back working memory task .
-METHODS	The key secondary measure was the change in task response latency .
-RESULTS	No significant differences were observed between treatment groups in the primary or key secondary outcomes .
-RESULTS	Armodafinil was generally well tolerated .
-RESULTS	The most common adverse events ( occurring in more than one patient [ 5 % ] ) were headache ( 19 % ) , nasopharyngitis ( 14 % ) , and diarrhea ( 10 % ) .
-CONCLUSIONS	Armodafinil did not improve fMRI-measured functional brain activation in CPAP-treated patients with OSA and excessive sleepiness .
-BACKGROUND	Double-Blind , Placebo-Controlled , Functional Neuroimaging Study of Armodafinil ( 200 mg/Day ) on Prefrontal Cortical Activation in Patients With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea .
-
-###24568271
-BACKGROUND	Antisocial behaviour and adult criminality often have their origins in childhood and are best addressed early in the child 's life using evidence-based treatments such as the ` Incredible Years Parent Programme ' .
-BACKGROUND	However , families with additional risk factors who are at highest risk for poor outcomes do not always make sufficient change while attending such programmes .
-BACKGROUND	Additional support to address barriers and improve implementation of positive parenting strategies while these families attend the Incredible Years Programme may improve overall outcomes.The study aims to evaluate the efficacy of adding a structured home visiting intervention ( Home Parent Support ) to improve outcomes in families most at risk of poor treatment response from the Incredible Years intervention .
-BACKGROUND	This study will inform the design of a larger prospective randomised controlled trial .
-METHODS	A pilot single-blind , parallel , superiority , randomised controlled trial .
-METHODS	Randomisation will be undertaken using a computer-generated sequence in a 1:1 ratio to the two treatments arranged in permuted blocks with stratification by age , sex , and ethnicity .
-METHODS	One hundred and twenty six participants enrolled in the Incredible Years Parent Programme who meet the high-risk criteria will be randomly allocated to receive either Incredible Years Parent Programme and Home Parent Support , or the Incredible Years Parent Programme alone .
-METHODS	The Home Parent Support is a 10-session structured home visiting intervention provided by a trained therapist , alongside the usual Incredible Years Parent Programme , to enhance the adoption of key parenting skills .
-METHODS	The primary outcome is the change in child behaviour from baseline to post-intervention in parent reported Eyberg Child Behavior Inventory Problem Scale .
-CONCLUSIONS	This is the first formal evaluation of adding Home Parent Support alongside Incredible Years Parent Programme for families with risk factors who typically have poorer treatment outcomes .
-CONCLUSIONS	We anticipate that the intervention will help vulnerable families stay engaged , strengthen the adoption of effective parenting strategies , and improve outcomes for both the children and families .
-BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12612000878875 .
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-###24717011
-BACKGROUND	Childhood obesity is a growing concern in Sweden .
-BACKGROUND	Children with overweight and obesity run a high risk of becoming obese as adults , and are likely to develop comorbidities .
-BACKGROUND	Despite the immense demand , there is still a lack of evidence-based comprehensive prevention programmes targeting pre-school children and their families in primary health care settings .
-BACKGROUND	The aims are to describe the design and methodology of the PRIMROSE cluster-randomised controlled trial , assess the relative validity of a food frequency questionnaire , and describe the baseline characteristics of the eligible young children and their mothers .
-METHODS	The PRIMROSE trial targets first-time parents and their children at Swedish child health centres ( CHC ) in eight counties in Sweden .
-METHODS	Randomisation is conducted at the CHC unit level .
-METHODS	CHC nurses employed at the participating CHC received training in carrying out the intervention alongside their provision of regular services .
-METHODS	The intervention programme , starting when the child is 8-9months of age and ending at age 4 , is based on social cognitive theory and employs motivational interviewing .
-METHODS	Primary outcomes are children 's body mass index and waist circumference at fouryears .
-METHODS	Secondary outcomes are children 's and mothers ' eating habits ( assessed by a food frequency questionnaire ) , and children 's and mothers ' physical activity ( measured by accelerometer and a validated questionnaire ) , and mothers ' body mass index and waist circumference .
-CONCLUSIONS	The on-going population-based PRIMROSE trial , which targets childhood obesity , is embedded in the regular national ( routine ) preventive child health services that are available free-of-charge to all young families in Sweden .
-CONCLUSIONS	Of the participants ( n = 1369 ) , 489 intervention and 550 control mothers ( 75.9 % ) responded to the validated physical activity and food frequency questionnaire at baseline ( i.e. , before the first intervention session , or , for children in the control group , before they reached 10months of age ) .
-CONCLUSIONS	The food frequency questionnaire showed acceptable relative validity when compared with an 8-day food diary .
-CONCLUSIONS	We are not aware of any previous RCT , concerned with the primary prevention of childhood obesity through sessions at CHC that addresses healthy eating habits and physical activity in the context of a routine child health services programme .
-BACKGROUND	ISRCTN16991919 .
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-###25074771
-OBJECTIVE	To investigate the effects of lutein supplementation on plasma lutein concentrations and the macular pigment optical density ( MPOD ) in central serous chorioretinopathy ( CSC ) .
-METHODS	In this double-masked placebo-controlled study , 20 patients received lutein 20 mg/d and 19 received placebo .
-METHODS	The plasma lutein concentration and MPOD using autofluorescence spectrometry ( density unit , DU ) were measured at baseline and 1 and 4 months .
-RESULTS	The mean plasma lutein concentrations and MPOD values in the lutein and control groups , respectively , were 91.5 and 78.2 ng/mL and 0.444 and 0.437 DU at baseline ; 204.9 and 79.3 ng/mL and 0.460 and 0.442 DU at 1 month ; and 228.0 and 78.4 ng/mL and 0.441 and 0.421 DU at 4 months .
-RESULTS	The plasma concentration in the lutein group was significantly higher than in controls at 1 and 4 months ( P < 0.0001 for both comparisons ) ; however , the MPOD values did not differ significantly between groups at 1 ( P = 0.479 ) or 4 months ( P = 0.883 ) .
-RESULTS	In patients with a plasma lutein concentration below the mean level in 20 age-matched healthy subjects ( mean 105.3 ng/mL ; n = 13 in lutein group , n = 15 in control group ) , the control MPOD values significantly ( P = 0.0430 ) decreased at 4 months ( mean baseline , 0.437 DU ; 4 months , 0.404 DU ) .
-RESULTS	The MPOD in the lutein group remained at the baseline level ( mean baseline , 0.426 DU ; 4 months , 0.438 DU ) ( P = 0.6542 ) .
-CONCLUSIONS	The MPOD did not increase in patients with CSC with short-term lutein supplementation ; however , among patients with low plasma lutein , supplemental lutein prevented a decline in MPOD that was observed in control subjects ( www.umin.ac.jp/ctr number , UMIN000005849 ) .
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-###24923683
-BACKGROUND	Fluid therapy is widely used in critically ill patients to restore effective intravascular volume and improve organ perfusion .
-BACKGROUND	Recent studies have questioned the administration of colloid-based solutions , especially if containing hydroxyethyl starch ( HES ) , in different ICU populations ; however , there is still uncertainty on the use of colloids as initial fluid therapy for early resuscitation .
-METHODS	The aim of this study was to investigate the effect of two different resuscitation fluid strategies on the mortality of patients with shock .
-METHODS	In a multicentric ( 57 ICUs ) , controlled , open-label trial ( from February 2003 to August 2012 ) , the authors randomized patients with signs of acute hypovolemia , defined by the combination of hypotension , evidence of low filling pressures or cardiac index and at least two signs of tissue hypoperfusion ( such as altered consciousness , mottled skin , oliguria , lactate levels > 2 mmol/L ) , to received either a colloid - or crystalloid-based therapy .
-METHODS	Both cohorts received maintenance fluids consisting in isotonic crystalloids and albumin in case of severe hypoalbuminemia ( < 2 g/dL ) .
-METHODS	Exclusion criteria included previous fluid therapy , pregnancy , brain death , extended burns , chronic hemodialysis or liver disease , known coagulopathy , acute anaphylaxis , dehydration and hypotension due to sedative drugs .
-RESULTS	Among the 6498 eligible patients , 2857 were eventually randomized in one of the two groups .
-RESULTS	The 28-day mortality was 25.4 % in the colloid and 27.0 % in the crystalloid group ( P = 0.26 ) .
-RESULTS	In the sub-group analysis , similar mortality rates were reported for shock due to hypovolemia , sepsis or trauma .
-RESULTS	Also , the use of continuous renal replacement therapy was similar between groups ( 11.0 % vs. 12.5 % , P = 0.19 ) .
-RESULTS	There were more days alive without mechanical ventilation or vasopressors during the first 7 and 28 days and a lower 90-day mortality in the colloid group .
-CONCLUSIONS	These data suggest that mortality was not increased and probably decreased with the use of colloids in different forms of shock requiring early fluid resuscitation .
-CONCLUSIONS	We discussed herein some methodological issues that may explain the discrepancies of this trial with the other studies developed in the same field .
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-###25515123
-BACKGROUND	Cochlear implantation with the aim of hearing preservation for combined electric-acoustic stimulation ( EAS ) is the therapy of choice for patients with residual low-frequency hearing .
-BACKGROUND	Preserved residual acoustic hearing has a positive effect on speech intelligibility in difficult noise conditions .
-OBJECTIVE	The goal of this study was to assess speech reception thresholds in various complex noise conditions for patients with EAS in comparison with patients using bilateral cochlear implants ( CI ) .
-METHODS	Speech perception in noise was measured for bilateral CI and EAS patient groups .
-METHODS	A total of 22 listeners with normal hearing served as a control group .
-METHODS	Speech reception thresholds ( SRT ) were measured using a closed-set sentence matrix test .
-METHODS	Speech was presented with a single source in frontal position ; noise was presented in frontal position or in a multisource noise field ( MSNF ) consisting of a four-loudspeaker array with independent noise sources .
-METHODS	Modulated speech-simulating noise and pseudocontinuous noise served respectively as interference signal with different temporal characteristics .
-RESULTS	The average SRTs in the EAS group were significantly better in all test conditions than those of the group with bilateral CI .
-RESULTS	Both user groups showed significant improvement in the MSNF condition compared with the frontal noise condition as a result of bilateral interaction .
-RESULTS	The normal-hearing control group was able to use short temporal gaps in modulated noise to improve speech perception in noise ( gap listening ) .
-RESULTS	This effect was absent in both implanted user groups .
-CONCLUSIONS	Patients with combined EAS in one ear and a hearing aid in the contralateral ear show significantly improved speech perception in complex noise conditions compared with bilateral CI recipients .
-
-###24702710
-BACKGROUND	Patient-reported outcomes ( PROs ) are particularly relevant in influenza vaccine trials in the elderly where reduction in symptom severity could prevent illness-related functional impairment .
-OBJECTIVE	To evaluate PROs in people aged 65 years receiving two different vaccines .
-METHODS	This was a phase III , randomised , observer-blind study ( NCT00753272 ) of the AS03-adjuvanted inactivated trivalent split-virion influenza vaccine ( AS03-TIV ) versus non-adjuvanted vaccine ( TIV ) .
-METHODS	Using the FluiiQ questionnaire , symptom ( systemic , respiratory , total ) and life impact ( activities , emotions , relationships ) scores were computed as exploratory endpoints , with minimal important difference ( MID ) in influenza severity between vaccines considered post-hoc as > 7 % .
-METHODS	Vaccine efficacy of AS03-TIV relative to TIV in severe influenza ( hospitalisation , complication , most severe one-third of episodes based on the area under the curve for systemic symptom score ) was calculated post-hoc .
-METHODS	The main analyses ( descriptive ) were conducted in the according-to-protocol cohort ( n = 280 AS03-TIV , n = 315 TIV ) for influenza confirmed by culture or reverse transcriptase polymerase chain reaction .
-RESULTS	Mean systemic symptom , total symptom and impact on activities scores were lower with AS03-TIV versus TIV .
-RESULTS	Mean respiratory symptom , impact on emotions and impact on relationships scores were similar .
-RESULTS	Influenza tended to be less severe with AS03-TIV , but the MID was reached only for impact on activities ( mean 9.0 % ) .
-RESULTS	Relative vaccine efficacy in severe influenza was 29.38 % ( 95 % CI : 7.60-46 .02 ) .
-CONCLUSIONS	AS03-TIV had advantages over TIV in impact on systemic symptoms and activities as measured by the FluiiQ in elderly people .
-CONCLUSIONS	Higher efficacy of AS03-TIV relative to TIV was shown for prevention of severe illness .
-
-###25733460
-BACKGROUND	Dietary patterns characterized by high intakes of fruits and vegetables , whole grains , low-fat dairy products , and low glycemic load have been associated with lower type 2 diabetes mellitus ( T2DM ) risk .
-BACKGROUND	In contrast , dietary patterns that include high intakes of refined grains , processed meats , and high amounts of added sugars have been associated with increased T2DM risk .
-OBJECTIVE	This randomized , 2-period crossover trial compared the effects of dairy and sugar-sweetened product ( SSP ) consumption on insulin sensitivity and pancreatic - cell function in men and women at risk of the development of T2DM who habitually consume sugar-sweetened beverages .
-METHODS	In a randomized , controlled crossover trial , participants consumed dairy products ( 474 mL/d 2 % milk and 170 g/d low-fat yogurt ) and SSPs ( 710 mL/d nondiet soda and 108 g/d nondairy pudding ) , each for 6 wk , with a 2-wk washout between treatments .
-METHODS	A liquid meal tolerance test ( LMTT ) was administered at baseline and the end of each period .
-RESULTS	Participants were 50 % female with a mean age and body mass index of 53.8 y and 32.2 kg/m ( 2 ) , respectively .
-RESULTS	Changes from baseline were significantly different between dairy product and SSP conditions for median homeostasis model assessment 2-insulin sensitivity ( HOMA2 - % S ) ( 1.3 vs. -21.3 % , respectively , P = 0.009 ; baseline = 118 % ) , mean LMTT disposition index ( -0.03 vs. -0.36 , respectively , P = 0.011 ; baseline = 2.59 ) , mean HDL cholesterol ( 0.8 vs. -4.2 % , respectively , P = 0.015 ; baseline = 44.3 mg/dL ) , and mean serum 25-hydroxyvitamin D [ 25 ( OH ) D ] ( 11.7 vs. -3.3 , respectively , P = 0.022 ; baseline = 24.5 g/L ) .
-RESULTS	Changes from baseline in LMTT Matsuda insulin sensitivity index ( -0.10 vs. -0.49 , respectively ; baseline = 4.16 ) and mean HOMA2 -- cell function ( -2.0 vs. 5.3 % , respectively ; baseline = 72.6 % ) did not differ significantly between treatments .
-CONCLUSIONS	These results suggest that SSP consumption is associated with less favorable values for HOMA2 - % S , LMTT disposition index , HDL cholesterol , and serum 25 ( OH ) D in men and women at risk of T2DM vs. baseline values and values during dairy product consumption .
-CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01936935 .
-
-###25205361
-BACKGROUND	Neurofibromatosis type 1 ( NF1 ) is an autosomal dominant disorder with an estimated prevalence of about 1/3000 , independent of ethnicity , race , or gender .
-BACKGROUND	Attention Deficit Hyperactivity like Disorder ( ADHD ) - like characteristics are often reported in patients with NF1 .
-BACKGROUND	We hypothesised that learning disabilities in NF1 children were related to ADHD symptoms .
-BACKGROUND	Treatment with methylphenidate ( MPD ) has improved learning disabilities in ADHD by acting on neurotransmitters .
-BACKGROUND	Our objective was to evaluate its efficacy on ADHD-like symptoms in neurofibromatosis type 1 children ( 7-12 years ) .
-METHODS	This was a randomised , double blind , placebo controlled , and crossover trial comparing 0.5 to 0.8 mg/kg/d of MPD as it is indicated for ADHD to placebo in NF1 children with ADHD-like symptoms .
-METHODS	Children aged 7 to 12years were eligible when their IQ was between 80 and 120 .
-METHODS	The total follow-up was 9weeks including 4weeks for each period and 1week wash out .
-METHODS	Fifty subjects ( 25 for each period ) were required for testing the primary study hypothesis .
-METHODS	The main outcome was an improvement in scores on the simplified Conners ' Parent Rating Scale .
-RESULTS	Thirty-nine patients were included between April 2004 and December 2010 .
-RESULTS	Twenty participants received MPD and 19 placebo during the first period .
-RESULTS	They all completed the trial .
-RESULTS	MPD decreased the simplified Conners by 3.9 points ( 1.1 , p = 0.0003 ) .
-CONCLUSIONS	This is the first randomised controlled trial showing the short-term benefit of MPD on simplified Conners scores in NF1 children .
-BACKGROUND	ClinicalTrials.gov NCT00169611 .
-
-###24467672
-BACKGROUND	Liver transection is considered a critical factor influencing intra-operative blood loss .
-BACKGROUND	A increase in the number of complex liver resections has determined a growing interest in new devices able to ` optimize ' the liver transection .
-BACKGROUND	The aim of this randomized controlled study was to compare a radiofrequency vessel-sealing system with the ` gold-standard ' clamp-crushing technique .
-METHODS	From January to December 2012 , 100 consecutive patients undergoing a liver resection were randomized to the radiofrequency vessel-sealing system ( LF1212 group ; N = 50 ) or to the clamp-crushing technique ( Kelly group , N = 50 ) .
-RESULTS	Background characteristics of the two groups were similar .
-RESULTS	There were not significant differences between the two groups in terms of blood loss , transection time and transection speed .
-RESULTS	In spite of a not-significant larger transection area in the LF1212 group compared with the Kelly group ( 51.5 versus 39cm ( 2 ) , P = 0.116 ) , the overall and ` per cm ( 2 ) ' blood losses were similar whereas the transection speed was better ( even if not significantly ) in the LF1212 group compared with the Kelly group ( 1.1 cm ( 2 ) / min versus 0.8 , P = 0.089 ) .
-RESULTS	Mortality , morbidity and bile leak rates were similar in both groups .
-CONCLUSIONS	The radiofrequency vessel-sealing system allows a quick and safe liver transection similar to the gold-standard clamp-crushing technique .
-
-###24582019
-BACKGROUND	Enamel demineralization and gingival inflammation are the most prevalent consequences of biofilm formation in orthodontics .
-BACKGROUND	Our hypothesis was that educating patients about the severe consequences of biofilm accumulation could enhance their oral hygiene while wearing fixed appliances .
-METHODS	This study was designed as a randomized controlled 4-arm parallel trial .
-METHODS	A total of 148 participants in Chengdu , China , matching the eligibility criteria of 11 to 25 years of age , at least 20 natural teeth , and a treatment plan that included conventional stainless steel brackets , were randomly assigned to 4 intervention groups based on computer-generated random sequencing using simple randomization without blocking .
-METHODS	In group A ( n = 37 ) , the subjects were shown images illustrating the severe consequences of biofilm formation , including enamel demineralization and gingival inflammation ; subjects in group B ( n = 40 ) were given biofilm disclosing tablets ; those in group C ( n = 38 ) received a combination of A and B ; the subjects in group D ( n = 33 ) served as the controls .
-METHODS	The investigators were blinded to the allocations , and the researcher managing the random sequence did not participate in allocation or measurement .
-METHODS	All groups received routine oral hygiene instructions .
-METHODS	Plaque index and gingival index scores were recorded at each appointment during a 6-month follow-up .
-RESULTS	Eighteen participants were lost during follow-up , resulting in a total of 130 participants after the trial ( group A , 35 ; group B , 32 ; group C , 34 ; group D , 29 ) .
-RESULTS	No adverse events were recorded .
-RESULTS	Groups A and C exhibited a significantly lower plaque index scores ( parameter-estimate [ 95 % confidence interval ] = -1.20 [ -1.76 to -0.63 ] for group A , and -1.12 [ -1.69 to -0.56 ] for group C ) and gingival index scores ( -0.13 [ -0.21 to -0.04 ] , and -0.19 [ -0.28 to -0.10 ] ) , respectively , compared with group D ( P < 0.001 for all ) , whereas no significant difference was found between groups B and D , or between groups A and C ( P > 0.05 ) .
-RESULTS	The adults had significantly lower plaque index ( 0.48 [ 0.13-0 .84 ] , P < 0.001 ) and gingival index ( 0.06 [ 0.01-0 .11 ] , P = 0.018 ) scores than did the teenagers , and the female subjects had significantly higher gingival index ( -0.06 [ -0.11 to -0.01 ] , P = 0.040 ) scores than did the male subjects .
-CONCLUSIONS	The use of images showing the severe consequences of biofilm accumulation enhanced the oral hygiene of patients treated with fixed appliances .
-
-###25307979
-OBJECTIVE	The purpose of the study is to compare neuromuscular electrical stimulation ( NMES ) vs sham on leg strength at hospital discharge in mechanically ventilated patients .
-METHODS	We conducted a randomized pilot study of NMES vs sham applied to 3 bilateral lower extremity muscle groups for 60 minutes daily in the intensive care unit ( ICU ) .
-METHODS	Between June 2008 and March 2013 , we enrolled adults who were receiving mechanical ventilation within the first week of ICU stay and who could transfer independently from bed to chair before hospital admission .
-METHODS	The primary outcome was lower extremity muscle strength at hospital discharge using Medical Research Council score ( maximum , 30 ) .
-METHODS	Secondary outcomes at hospital discharge included walking distance and change in lower extremity strength from ICU awakening .
-METHODS	Clinicaltrials.gov : NCT00709124 .
-RESULTS	We stopped enrollment early after 36 patients due to slow patient accrual and the end of research funding .
-RESULTS	For NMES vs sham , mean ( SD ) lower extremity strength was 28 ( 2 ) vs 27 ( 3 ) , P = .072 .
-RESULTS	Among secondary outcomes , NMES vs sham patients had a greater mean ( SD ) walking distance ( 514 [ 389 ] vs 251 [ 210 ] ft , P = .050 ) and increase in muscle strength ( 5.7 [ 5.1 ] vs 1.8 [ 2.7 ] , P = .019 ) .
-CONCLUSIONS	In this pilot randomized trial , NMES did not significantly improve leg strength at hospital discharge .
-CONCLUSIONS	Significant improvements in secondary outcomes require investigation in future research .
-
-###24721240
-OBJECTIVE	To prospectively evaluate the efficacy of a traditional Chinese medicine ( TCM ) - based therapy for treating liver fibrosis in patients with chronic hepatitis B ( CHB ) , and to investigate the patients ' perception of the treatment 's effects on quality of life ( QoL ) .
-METHODS	A total of 430 patients with CHB-related liver fibrosis were randomly assigned to treatment groups for receipt of a 12-month course of the antiviral drug entecavir alone ( control group ) or in combination with the TCM Liuweiwuling tablets .
-METHODS	Patients were assessed before ( pre-treatment ) and after therapy and the treatment-related differences in clinical manifestations , levels of liver function markers and liver fibrosis indexes , color ultrasound images , and hepatitis B virus ( HBV ) DNA load were compared between the two groups by statistical analysis .
-METHODS	The generic QoL scale developed by the World Health Organization ( WHOQOL-BREF ) was used to score the patients ' perceptions of treatment outcome .
-RESULTS	After treatment , the patients in both groups showed significant improvement in the majority of clinical manifestations ( both P less than 0.05 ) , with the exception of bloating .
-RESULTS	In addition , both groups showed significant improvements of liver function markers and in signs of liver fibrosis ( both P less than 0.05 ) .
-RESULTS	Both groups also showed significant reductions in the diameters of the portal and splenic ( both P less than 0.05 ) , as well as increases in the rate of undetectable HBV DNA ( with a statistically similar outcome achieved in the two groups ) .
-RESULTS	Finally , both groups had higher QoL scores after treatment , with all assessed parameters except environment showing a significant improvement ( all P less than 0.05 ) .
-CONCLUSIONS	When used in combination with entecavir , the TCM Liuweiwuling tablet is a safe therapy for CHB and its related liver fibrosis and may help to improve the QoL of these patients .
-
-###25425308
-OBJECTIVE	Progressive decline of psychophysical cone-mediated measures has been reported in type 1 ( USH1 ) and type 2 ( USH2 ) Usher syndrome .
-OBJECTIVE	Conventional cone electroretinogram ( ERG ) responses in USH demonstrate poor signal-to-noise ratio .
-OBJECTIVE	We evaluated cone signals in USH1 and USH2 by recording microvolt level cycle-by-cycle ( CxC ) ERG .
-METHODS	Responses of molecularly genotyped USH1 ( n = 18 ) and USH2 ( n = 24 ) subjects ( age range , 15-69 years ) were compared with those of controls ( n = 12 ) .
-METHODS	A subset of USH1 ( n = 9 ) and USH2 ( n = 9 ) subjects was examined two to four times over 2 to 8 years .
-METHODS	Photopic CxC ERG and conventional 30-Hz flicker ERG were recorded on the same visits .
-RESULTS	Usher syndrome subjects showed considerable cone flicker ERG amplitude losses and timing phase delays ( P < 0.01 ) compared with controls .
-RESULTS	USH1 and USH2 had similar rates of progressive logarithmic ERG amplitude decline with disease duration ( -0.012 log V/y ) .
-RESULTS	Of interest , ERG phase delays did not progress over time .
-RESULTS	Two USH1C subjects retained normal response timing despite reduced amplitudes .
-RESULTS	The CxC ERG method provided reliable responses in all subjects , whereas conventional ERG was undetectable in 7 of 42 subjects .
-CONCLUSIONS	Cycle-by-cycle ERG showed progressive loss of amplitude in both USH1 and USH2 subjects , comparable to that reported with psychophysical measures .
-CONCLUSIONS	Usher subjects showed abnormal ERG response latency , but this changed less than amplitude with time .
-CONCLUSIONS	In USH syndrome , CxC ERG is more sensitive than conventional ERG and warrants consideration as an outcome measure in USH treatment trials .
-
-###25740265
-OBJECTIVE	This study aimed to evaluate influence of ethnic factors on the pharmacokinetics of orally inhaled QMF149 , a novel combination of an approved longacting 2-agonist , indacaterol ( Onbrez Breezhaler for COPD ) , and an approved inhaled corticosteroid , mometasone furoate ( MF ) , ( Asmanex Twisthaler for asthma ) , following multiple dose administration of QMF149 ( indacaterol acetate/MF ) 150/80 g and 150/320 g via the Breezhaler device in healthy Japanese and Caucasian subjects .
-METHODS	This was a single-center , openlabel , multiple-dose , two-period , complete crossover study that randomized healthy Japanese and , age and weight matched Caucasian subjects to QMF149 150/80 g or 150/320 g once daily ( o.d. ) for 14 days in each period .
-METHODS	Pharmacokinetics ( PK ) were assessed up to 24 hours on days 1 and 14 .
-RESULTS	24 Japanese and 24 Caucasian healthy subjects were enrolled .
-RESULTS	Indacaterol and MF had similar PK profiles across both the doses and both ethnic groups .
-RESULTS	The maximum geometric mean ratios ( 90 % confidence interval ( CI ) ) for Japanese vs. Caucasian subjects for Cmax were 1.23 ( 1.11 - 1.38 ) and 1.24 ( 1.11 - 1.38 ) for indacaterol and MF , respectively .
-RESULTS	For AUC , the maximum ratios were 1.22 ( 1.09 - 1.36 ) and 1.30 ( 1.18 - 1.44 ) for indacaterol and MF , respectively .
-RESULTS	The mild trend towards higher exposure in Japanese subjects could be explained by the fact that the mean body weight was 14 % higher for Caucasians compared to their Japanese counterparts .
-RESULTS	No serious adverse events or discontinuations related to study medication were reported .
-CONCLUSIONS	The study demonstrated increase of mean exposure parameters in Japanese subjects vs. Caucasian subjects , which ranged between 19 - 23 % and 17 - 30 % , for indacaterol and MF components , respectively .
-CONCLUSIONS	Multiple doses of both the QMF149 dose levels were safe and well-tolerated in all subjects .
-CONCLUSIONS	Body weight was considered a key contributory factor for the observed difference in exposure .
-CONCLUSIONS	These results suggest no dose adjustment for QMF149 is required in Asian populations .
-
-###25455834
-OBJECTIVE	The purpose of this study is to measure the prevalence of graded disc degeneration , spondylolisthesis , transitional segmentation , and the distribution of sacral slope in patients 21 to 65 years of age with chronic low back pain ( CLBP ) .
-METHODS	This retrospective study analyzed 247 digital lumbar radiographic series obtained during a randomized controlled trial of chiropractic patients with CLBP .
-METHODS	Chronic low back pain was defined as pain in the low back lasting 12 weeks or longer .
-METHODS	Radiographic findings of disc degeneration , spondylolisthesis , and lumbosacral transitional segmentation were graded by 2 authors using established classification criteria .
-METHODS	Sacral slope was measured with a digital tool contained within imaging software .
-RESULTS	Lumbosacral transitional segments graded I to IV ( Castellvi classification ) were present in 14 % of cases .
-RESULTS	Lumbar disc degeneration was most prevalent at L3-4 ( 49 % ) , followed by L4-5 ( 42 % ) , L2-3 ( 41 % ) , L5-S1 ( 37 % ) , and L1-2 ( 29 % ) .
-RESULTS	Isthmic spondylolisthesis was present in 5 % of cases , with L5 the most common location .
-RESULTS	Degenerative spondylolisthesis demonstrated a prevalence of 18 % , most commonly occurring at L4 .
-RESULTS	The prevalence of degenerative spondylolisthesis was 51 % for women aged 50 to 59 years and 24 % for men in the same age range .
-CONCLUSIONS	Moderate-severe disc degeneration , multilevel disc narrowing , and degenerative spondylolisthesis were common in individuals with CLBP with age more than 40 years .
-CONCLUSIONS	Isthmic spondylolisthesis was not more prevalent than what has been reported in other populations .
-CONCLUSIONS	Transitional segmentation was identified in a minority of participants , with some of these exhibiting accessory joints or fusion .
-CONCLUSIONS	Mean sacral slope in individuals with CLBP was not substantially different from mean slopes reported in other populations .
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-###25087835
-OBJECTIVE	( 1 ) Compare ideal cut-off points for DS and % FEV1 at 1 and 3hto predict hospitalization/relapse in subjects with moderate to severe asthma exacerbation ( 2 ) Develop a multivariate regression model using DS , % FEV1 , demographic , and clinical variables to predict hospitalization/relapse .
-METHODS	Subjects with acute exacerbation of asthma ( FEV1 < 50 % predicted following 30minof standardized treatment : 5mg nebulized albuterol ; 0.5-1 .5 mg nebulized ipratropium ; and 50mg oral prednisone ) were eligible .
-METHODS	All subjects had % FEV1 and DS obtained at baseline and hourly for 3h .
-METHODS	Using hospitalization/relapse as the outcome of interest ; we compared the area under the receiveroperator curves ( AUC ) between the 1 and 3hDS and % FEV1 measurements , and the AUC for the change in DS and % FEV1 between baseline and hour-3 .
-METHODS	We determined ideal cut-points for % FEV1 and DS to maximize sensitivity and specificity .
-METHODS	Sensitivity , specificity , positive and negative predictive values , and positive and negative likelihood ratios ( LR ) were compared between % FEV1 and DS .
-METHODS	We developed a multivariate regression model examining the association of specific demographic and clinical variables to hospitalization/relapse .
-RESULTS	142 patients were included for analysis .
-RESULTS	The AUC was greatest for the 3-hDS ( 0.721 ) , followed by the 3-h % FEV1 ( 0.669 ) .
-RESULTS	Optimum cut-off values were a DS of 2 , and an FEV1 of 42 % .
-RESULTS	These were associated with a + LR for the composite outcome of 3.06 and 2.48 respectively .
-RESULTS	Logistic regression showed baseline DS , 3-hDS , change in DS , and oxygen use at hour 3 were all associated with the composite outcome .
-CONCLUSIONS	The 3-hscore for % FEV1 and DS performed better than scores at any other time point and better than either parameter over time .
-CONCLUSIONS	The 3-hDS had the greatest association with the composite outcome .
-CONCLUSIONS	Neither test was a strong enough predictor to be used solely for this purpose .
-
-###24508922
-BACKGROUND	Sarcopenia is currently best described as an age-related decline in skeletal muscle mass and function .
-BACKGROUND	However , no consensus exists as to how to best quantify muscle function in older adults .
-BACKGROUND	The muscle quality index ( MQI ) was recently recommended as an ideal evidence-based assessment of functional status in older adults .
-BACKGROUND	Nevertheless , the usefulness of MQI to assess physical function is limited by whether it is reflective of muscle qualitative changes to an intervention .
-BACKGROUND	Thus , the purpose of this investigation was to determine whether MQI changes in response to resistance exercise training and detraining and how such changes correspond to other recommended measures of physical function proposed by suggested definitions of sarcopenia .
-METHODS	Twenty-five older adults ( 70.66.1 y ; BMI = 28.15.4 kgm ( -2 ) ) completed a 6-week resistance training program in a wait-list controlled , cross-over design .
-METHODS	MQI was determined as power output from timed sit to stand ( STS ) , body mass , and leg length .
-METHODS	Gait speed , hand grip strength , get-up-and-go and lean body mass ( LBM ) were evaluated before and after exercise training and detraining .
-METHODS	MQI and functional changes to training and detraining were evaluated with repeated measures ANOVA and clinical interpretations of magnitude based inferences .
-RESULTS	Short term resistance training significantly and clinically improved MQI ( 203.464.31 to 244.382.92 W ) , gait time ( 1.850.36 to 1.660.27 s ) and sit to stand performance ( 13.212.51 to 11.051.58 s ) .
-RESULTS	Changes in LBM and hand grip strength were not significant or clinically meaningful .
-RESULTS	De-training for 6-weeks did not result in significant changes in any measure from post-training performance .
-
-###24245738
-BACKGROUND	The decreased number and senescence of circulating endothelial progenitor cells ( EPCs ) are considered markers of vascular senescence associated with aging , atherosclerosis , and coronary artery disease ( CAD ) in elderly .
-BACKGROUND	In this study , we explore the role of vascular senescence in premature CAD ( PCAD ) in a developing country by comparing the numerical status and senescence of circulating EPCs in PCAD patients to controls .
-METHODS	EPCs were measured by flow cytometry in 57 patients with angiographically documented CAD , and 57 controls without evidence of CAD , recruited from random patients 50 years of age at All India Institute of Medical Sciences .
-METHODS	EPC senescence as determined by telomere length ( EPC-TL ) and telomerase activity ( EPC-TA ) was studied by real time polymerase chain reaction ( q PCR ) and PCR - ELISA respectively .
-RESULTS	The number of EPCs ( 0.18 % Vs. 0.039 % of total WBCs , p < 0.0001 ) , and EPC-TL ( 3.83 Vs. 5.10 kb/genome , p = 0.009 ) were markedly lower in PCAD patients compared to controls .
-RESULTS	These differences persisted after adjustment for age , sex , BMI , smoking and medications .
-RESULTS	EPC-TA was reduced in PCAD patients , but was statistically significant only after adjustment for confounding factors ( 1.81 Vs. 2.20 IU/cell , unadjusted p = 0.057 , adjusted p = 0.044 ) .
-CONCLUSIONS	We observed an association between increased vascular cell senescence with PCAD in a sample of young patients from India .
-CONCLUSIONS	This suggests that early accelerated vascular cell senescence may play an important mechanistic role in CAD epidemic in developing countries like India where PCAD burden is markedly higher compared to developed countries .
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-###25509730
-OBJECTIVE	To compare the clinical efficacy differences between medicinal vesiculation combined with quick cupping at Shenque ( CV 8 ) and regular medication for allergic rhinitis with syndrome of yang deficiency .
-METHODS	Eighty-two cases were randomly divided into an observation group ( 42 cases ) and a control group ( 40 cases ) .
-METHODS	The observation group was treated with medicinal vesiculation combined with quick cupping at Shenque ( CV 8 ) .
-METHODS	The medicinal vesiculation was applied at Feishu ( BL 13 ) , Gaohuang ( BL 43 ) , Fengmen ( BL 12 ) , Mingmen ( GV 4 ) on the dog days in the summer , one treatment on the 1st dog-day , 2nd dog-day and last dog-day respectively with an interval of 10 days between two treatments .
-METHODS	Three treatments were taken as one course , and totally one course was given .
-METHODS	The quick cupping was applied at Shenque ( CV 8 ) , once a day , ten treatments were taken as one course , and totally three courses was given .
-METHODS	The control group was treated with oral administration of loratadine and nasal spray of budesonide .
-METHODS	The loratadine was given 10 mg per time , once a day for continuous 14 days ; budesonide was given once a day , ten treatments were taken as one course , and totally three courses was given .
-METHODS	The clinical efficacy in two groups after treatment was observed , and the contents of immune globulin E ( IgE ) , interleukin-4 ( IL-4 ) , interleukin-5 ( IL-5 ) and tumor necrosis factor - ( TNF - ) in peripheral serum were measured before and after the treatments .
-RESULTS	Of all the 82 patients , 79 cases completed the treatment , and 1 patient in the observation group and 2 patients in the control group dropped out .
-RESULTS	The effective rate was 87.8 % ( 36/41 ) in the observation group , which was superior to 78.9 % ( 30/38 ) in the control group ( P < 0.05 ) .
-RESULTS	After treatment , both groups effectively reduced the contents of IgE , IL-4 , IL-5 and TNF - , and the observation group had superior effect on reducing IgE and IL-4 to the control group ( P < 0.05 ) .
-CONCLUSIONS	The medicinal vesiculation combined with quick cupping at Shenque ( CV 8 ) have better effect for allergic rhinitis with syndrome of yang deficiency than oral administration of loratadine and nasal spray of budesonide .
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-###24755125
-OBJECTIVE	Tamsulosin and mirabegron may be used concomitantly in patients with lower urinary tract symptoms .
-OBJECTIVE	Since alpha1-adrenoceptor antagonists are associated with cardiovascular side effects , potential pharmacokinetic and cardiovascular interactions were evaluated .
-METHODS	This was an open-label , randomized , 2-arm , 2-sequence study in 48 healthy men ( 24/arm ) aged 44 - 72 years .
-METHODS	In arm 1 , subjects received single-dose tamsulosin hydrochloride modified release capsules ( 0.4 mg ) alone and with steady-state mirabegron oral controlled absorption system tablets ( 100 mg once daily ) in random sequence .
-METHODS	In arm 2 , subjects received single-dose mirabegron alone and with steady-state tamsulosin .
-METHODS	Samples for mirabegron and tamsulosin plasma concentrations were collected .
-METHODS	Blood pressure ( BP ) and pulse rate ( PR ) were measured and orthostatic stress tests were performed .
-RESULTS	Mirabegron increased tamsulosin C ( max ) to 159 % ( 90 % confidence interval ( CI ) 143 - 177 % ) , AUC ( ) to 161 % ( 90 % CI 149 - 173 % ) , and t ( 1/2 ) to 116 % .
-RESULTS	Tamsulosin reduced mirabegron C ( max ) to 85 % ( 90 % CI 71 - 103 % ) and AUC ( ) to 84 % ( 90 % CI 74 - 95 % ) without effect on t1/2 .
-RESULTS	Mirabegron and tamsulosin co-treatment caused no statistically significant changes ( p > 0.05 ) in PR or systolic BP versus mono-treatment up to 12 hours post-dose .
-RESULTS	Mean diastolic BP decreases of -2.1 ( 95 % CI -4.1 , -0.1 ) to -4.2 ( -7.5 , -0.9 ) mmHg in arm 1 and -3.0 ( -5.7 , -0.3 ) to -4.2 ( -7.4 , -1.0 ) mmHg in arm 2 were observed , statistically significant ( p < 0.05 ) at several time points , not accompanied by orthostatic symptoms or increases in positive orthostatic stress tests .
-RESULTS	Adverse and orthostatic events were balanced across treatments .
-CONCLUSIONS	The observed pharmacokinetic interactions upon add-on of mirabegron or tamsulosin to existing tamsulosin or mirabegron therapy did not cause clinically relevant changes in cardiovascular safety or safety profiles .
-
-###25145986
-BACKGROUND	The efficacy of single-allergen-specific immunotherapy in polysensitized subjects is a matter of debate .
-BACKGROUND	This study aimed to investigate the efficacy of house dust mite ( HDM ) sublingual immunotherapy ( SLIT ) in monosensitized and polysensitized children .
-METHODS	A total of 112 children , aged 4 to 13 years old , with HDM-induced respiratory allergic diseases were allocated to a monosensitized group ( n = 56 ) or a polysensitized group ( n = 56 ) .
-METHODS	Both groups were treated by standard pharmacotherapy and SLIT with Dermatophagoides farinae ( American HDM ) extracts for 52 weeks .
-METHODS	Symptoms , medications , visual analogue scale ( VAS ) , and presence of adverse events ( AEs ) were assessed once a month .
-METHODS	Skin-prick test ( SPT ) was done before and after treatment .
-METHODS	After treatment , subjects in the polysensitized group who completed the study were further analyzed as subgroup 1 ( n = 20 ) and subgroup 2 ( n = 15 ) according to the number of coexisting allergens .
-RESULTS	Forty-one subjects in the monosensitized group and 35 subjects in the polysensitized group completed the study .
-RESULTS	The global clinical parameters had significantly improved after treatment , with no significant difference between the monosensitized and polysensitized group throughout this period ( all p > 0.05 ) .
-RESULTS	The comparison among the monosensitized group , subgroup 1 , and subgroup 2 indicated that there was no significant difference in symptoms scores and VAS at each scheduled follow-up visit .
-RESULTS	There was also no significant difference in total medications score ( TMS ) in the monosensitized group , subgroup 1 , and subgroup 2 after week 24 ( all p > 0.05 ) .
-RESULTS	No severe systemic AEs were reported .
-CONCLUSIONS	No significant difference was observed in the clinical effects of HDM SLIT between polysensitized and monosensitized children with respiratory allergic diseases .
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-###25213566
-BACKGROUND	Obesity is associated with cardiometabolic disease , including insulin resistance ( IR ) and diabetes .
-BACKGROUND	Cyclic guanosine monophosphate ( cGMP ) signaling affects energy balance , IR , and glucose metabolism in experimental models .
-BACKGROUND	We sought to examine effects of phosphodiesterase-5 inhibition with tadalafil on IR in a pilot study of obese nondiabetic individuals .
-RESULTS	We conducted a randomized , double-blinded , placebo-controlled trial of adults age 18 to 50 years with obesity and elevated fasting insulin levels ( 10 U/mL ) .
-RESULTS	Participants were randomized to tadalafil 20 mg daily or placebo for 3 months .
-RESULTS	Oral glucose tolerance tests were performed , and the effect of tadalafil on IR was examined .
-RESULTS	A total of 53 participants ( mean age , 33 years ; body mass index [ BMI ] , 38 kg/m ( 2 ) ) were analyzed , 25 randomized to tadalafil and 28 to placebo .
-RESULTS	In the overall sample , measures of IR did not differ between tadalafil and placebo groups at 3 months .
-RESULTS	However , in individuals with severe obesity ( BMI 36.2 kg/m ( 2 ) ) , tadalafil use was associated with improved IR ( homeostatic model assessment for IR ) , compared to placebo ( P = 0.02 , respectively ) .
-RESULTS	Furthermore , one measure of - cell compensation for IR ( oral disposition index ) improved with tadalafil in the overall sample ( P = 0.009 ) and in the subgroup with severe obesity ( P = 0.01 ) .
-CONCLUSIONS	Results of this pilot study did not show improvements in IR with tadalafil , compared to placebo .
-CONCLUSIONS	However , tadalafil may have favorable effects on - cell compensation , particularly in individuals with severe obesity .
-CONCLUSIONS	Future studies evaluating the potential metabolic benefits of cGMP modulation in obesity are warranted .
-BACKGROUND	ClinicalTrials.gov .
-BACKGROUND	Unique Identifier : NCT01444651 .
-
-###25031315
-BACKGROUND	Inpatient medical settings offer an opportunistic environment for initiating smoking cessation interventions to patients reflecting on their health .
-BACKGROUND	Current evidence has shown the superior efficacy of varenicline tartrate ( VT ) for smoking cessation compared with other tobacco cessation therapies ; however , recent evidence also has highlighted concerns about the safety and tolerability of VT. .
-BACKGROUND	Given these apprehensions , we aimed to evaluate the safety and effectiveness of VT plus quitline-counseling compared to quitline-counseling alone in the inpatient medical setting .
-METHODS	Adult patients ( n = 392 , 20-75 years ) admitted with a smoking-related illnesses to 3 hospitals were randomized to receive either 12 weeks of varenicline tartrate ( titrated from 0.5 mg daily to 1mg twice daily ) plus quitline-counseling ( VT+C ) , ( n = 196 ) or quitline-counseling alone ( n = 196 ) .
-RESULTS	VT was well tolerated in the inpatient setting among subjects admitted with acute smoking-related illnesses ( mean age 52.82.89 and 53.72.77 years in the VT+C and counseling alone groups , respectively ) .
-RESULTS	The most common self-reported adverse event during the 12-week treatment phase was nausea ( 16.3 % in the VT+C group compared with 1.5 % in the counseling alone group ) .
-RESULTS	Thirteen deaths occurred during the study period ( n = 6 were in the VT+C arm compared with n = 7 in the counseling alone arm ) .
-RESULTS	All of these subjects had known comorbidities or developed underlying comorbidities .
-CONCLUSIONS	VT appears to be a safe and well-tolerated opportunistic treatment for inpatient smokers who have related chronic disease .
-CONCLUSIONS	Based on the proven efficacy of varenicline from outpatient studies and our recent inpatient evidence , we suggest it be considered as part of standard care in the hospital setting .
-
-###25010883
-OBJECTIVE	Although the VITA 3D-Master ( 3D ) shade guide offers improved shade-matching performance , many dental materials are only available in VITA Classical ( VC ) shades .
-OBJECTIVE	This study aimed to clarify whether it is possible to convert 3D shades determined by observers into VC shades ( indirect method ) without adding a clinically significant error in comparison with direct shade determination using the VC shade guide .
-METHODS	Forty ceramic specimens were fabricated .
-METHODS	L * a * b * values were recorded using a spectroradiometer .
-METHODS	Sixty participants ( 35 dentists , 15 technicians , and 10 students ) were recruited and asked to determine the shades of specimens using the VC and 3D shade guides under standardized conditions .
-METHODS	Conversion tables were constructed by allocating the closest VC shade tab to every matched 3D shade and by use of an optimization algorithm ( indirect methods ) .
-METHODS	Differences between E values for VC matches and for the indirect methods were evaluated using t tests .
-RESULTS	A mean E ( SD ) of 4.34 ( 2.00 ) for VC and 4.22 ( 2.21 ) for 3D was observed ( P = .040 ) .
-RESULTS	Compared with direct shade matching using VC , the indirect method with the optimized tables resulted in a mean E of 4.32 ( 1.96 ) , which was not significantly different ( P = .586 ) .
-CONCLUSIONS	Within the limitations of this study , the conversion tables were suitable for the determination of tooth color using the 3D shade guide followed by conversion into VC shades without adding a clinically significant error .
-
-###24498875
-BACKGROUND	It has been well documented that the maturing oocyte is very vulnerable to changes in its micro-environment , the follicular fluid ( FF ) .
-BACKGROUND	Recent research has focused on different components within this FF , like hormones , growth factors and metabolites , and how their concentrations are altered by diet and the metabolic health of the mother .
-BACKGROUND	It has been proposed that fatty acids ( FAs ) are potential factors that influence oocyte maturation and subsequent embryo development .
-BACKGROUND	However , a thorough study of the specific FF FA composition per lipid fraction and how this may be affected by BMI is currently lacking .
-BACKGROUND	Therefore , we investigated the BMI-related concentration of FAs in the phospholipid ( PL ) , cholesteryl-ester ( CHE ) , triglyceride ( TG ) and non-esterified ( NE ) lipid fraction in the FF of women undergoing assisted reproductive treatment ( ART ) .
-METHODS	In this descriptive cross-sectional study , the FF of normal weight ( 18.5 BMI < 25.0 kg/m ( 2 ) , n = 10 ) , overweight ( 25.0 BMI < 30.0 kg/m ( 2 ) , n = 10 ) and obese ( BMI30 .0 kg/m ( 2 ) , n = 10 ) women , undergoing ART , was sampled and analyzed for 23 specific FAs in the PL , CHE , TG and NEFA fraction , using a gas chromatographic analysis method .
-METHODS	Differences between BMI-groups were studied by means of univariate general linear models and post hoc Sheff tests .
-RESULTS	Total FA concentrations in the PL and CHE fraction did not differ between BMI groups .
-RESULTS	Total TG concentrations tended to differ and total NEFA concentrations differed significantly between BMI groups .
-RESULTS	Interestingly , 42 % and 34 % of the total FAs was esterified in the PL and CHE fraction , respectively , while only 10 % were present in both the TG and NEFA fraction .
-RESULTS	Only few individual FA concentrations differed in the PL , CHE and TG fraction between BMI groups , whereas abundant BMI-related differences were found in the NEFA fraction .
-CONCLUSIONS	Our data show that differences in BMI are associated with alterations in the FA composition of the FF , an effect most pronounced in the NEFA fraction .
-CONCLUSIONS	These BMI-related variations could possibly affect granulosa cell viability , oocyte developmental competence and subsequent embryo quality possibly explaining differences in oocyte quality in obese patients described by others .
-
-###24283282
-OBJECTIVE	To compare three children 's sodium fluoride toothpastes to placebo with respect to enamel remineralisation potential , enamel fluoride uptake and net acid resistance using an in situ palatal caries model in children aged 11-14 years following a single brushing .
-METHODS	This was a randomised , single blind ( laboratory analyst ) , single-centre , four-treatment , crossover study with a 7-day washout period between treatments .
-METHODS	The treatments were 1,426 ppm fluoride , 1,000 ppm fluoride , 500 ppm fluoride and 0 ppm fluoride ( placebo ) toothpaste ( NaF/silica ) .
-METHODS	A custom made in situ palatal appliance was used by each subject in all treatment periods .
-METHODS	At each of the four treatment visits subjects wore the appliance containing four partially demineralised human enamel specimens for 5 minutes and then brushed their teeth using a standardised procedure for 60 seconds under supervision using 1.0 g ( 0.1 g ) of their assigned toothpaste .
-METHODS	After 4 hours the appliance was removed and enamel specimen recovered .
-METHODS	This process was repeated until all subjects completed all four study treatment visits .
-METHODS	Recovered enamel specimens were analysed for per cent surface microhardness recovery ( % SMHR ; Knoop ) and enamel fluoride uptake ( EFU ; microdrill biopsy ) .
-METHODS	Subsequently , specimens were demineralised in vitro to determine their % net acid resistance ( % NAR ; Knoop ) .
-RESULTS	All three fluoride toothpastes demonstrated significantly greater % SMHR , EFU and % NAR compared with 0 ppm F toothpaste .
-RESULTS	The model demonstrated a dose response over the range 0 to 1,426 ppm fluoride for % SMHR , EFU and % NAR .
-RESULTS	There was no significant difference between 500 ppm F and 1,000 ppm F for % SMHR and between 1,000 ppm F and 1,426 ppm F for % SMHR , EFU and % NAR .
-CONCLUSIONS	The present in situ study demonstrated that the children 's fluoride toothpastes tested are capable of delivering cariostatic amounts of fluoride to early caries lesions following a single brushing .
-
-###24281004
-BACKGROUND	This randomised phase II trial compared dose-escalated weekly paclitaxel ( wPTX ) vs standard-dose wPTX for patients with previously treated advanced gastric cancer ( AGC ) .
-METHODS	Ninety patients were randomised to a standard dose of wPTX ( 80mgm ( -2 ) ) or an escalated dose of wPTX ( 80-120mgm ( -2 ) ) to assess the superiority of overall survival ( OS ) with a one-sided alpha error of 0.3 and a power of 0.8 .
-RESULTS	The median OS showed a trend towards longer survival in the dose-escalated arm ( 11.8 vs 9.6 months ; hazard ratio ( HR ) , 0.75 ; one-sided P = 0.12 ) , although it was statistically not significant .
-RESULTS	The median progression-free survival ( PFS ) was significantly longer in the dose-escalated arm ( 4.3 vs 2.5 months , HR , 0.55 ; P = 0.017 ) .
-RESULTS	Objective response rate was 30.3 % with dose escalation and 17.1 % with standard dose ( P = 0.2 ) .
-RESULTS	The frequency of all grades of neutropenia was significantly higher with dose escalation ( 88.7 % vs 60.0 % , P = 0.002 ) ; however , no significant difference was observed in the proportion of patients experiencing grade 3 or more ( 40.9 % vs 31.1 % , P = 0.34 ) .
-CONCLUSIONS	Dose-escalated wPTX in patients with pretreated AGC met our predefined threshold of primary end point , OS ( P < 0.3 ) ; however , it did not show a significantly longer OS .
-CONCLUSIONS	Progression-free survival was significantly better with dose escalation .
-
-###25833983
-BACKGROUND	Abdominal obesity and exaggerated postprandial lipemia are independent risk factors for cardiovascular disease ( CVD ) and mortality , and both are affected by dietary behavior .
-OBJECTIVE	We investigated whether dietary supplementation with whey protein and medium-chain saturated fatty acids ( MC-SFAs ) improved postprandial lipid metabolism in humans with abdominal obesity .
-METHODS	We conducted a 12-wk , randomized , double-blinded , diet intervention study .
-METHODS	Sixty-three adults were randomly allocated to one of 4 diets in a 2 2 factorial design .
-METHODS	Participants consumed 60 g milk protein ( whey or casein ) and 63 g milk fat ( with high or low MC-SFA content ) daily .
-METHODS	Before and after the intervention , a high-fat meal test was performed .
-METHODS	We measured changes from baseline in fasting and postprandial triacylglycerol , apolipoprotein B-48 ( apoB-48 ; reflecting chylomicrons of intestinal origin ) , free fatty acids ( FFAs ) , insulin , glucose , glucagon , glucagon-like peptide 1 ( GLP-1 ) , and gastric inhibitory polypeptide ( GIP ) .
-METHODS	Furthermore , changes in the expression of adipose tissue genes involved in lipid metabolism were investigated .
-METHODS	Two-factor ANOVA was used to examine the difference between protein types and fatty acid compositions , as well as any interaction between the two .
-RESULTS	Fifty-two participants completed the study .
-RESULTS	We found that the postprandial apoB-48 response decreased significantly after whey compared with casein ( P = 0.025 ) independently of fatty acid composition .
-RESULTS	Furthermore , supplementation with casein resulted in a significant increase in the postprandial GLP-1 response compared with whey ( P = 0.003 ) .
-RESULTS	We found no difference in postprandial triacylglycerol , FFA , insulin , glucose , glucagon , or GIP related to protein type or MC-SFA content .
-RESULTS	We observed no interaction between milk protein and milk fat on postprandial lipemia .
-CONCLUSIONS	We found that a whey protein supplement decreased the postprandial chylomicron response compared with casein in persons with abdominal obesity , thereby indicating a beneficial impact on CVD risk .
-CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01472666 .
-
-###25342896
-BACKGROUND	Aging involves a progressive reduction of respiratory muscle strength as well as muscle strength .
-OBJECTIVE	Compare the effects of resistance training volume on the maximum inspiratory pressure ( MIP ) , maximum expiratory pressure ( MEP ) , functional performance , and muscle strength in elderly women .
-METHODS	Thirty elderly women were randomly assigned to a group performing either single sets ( 1-SET ) or three sets ( 3-SET ) of exercises .
-METHODS	The sit-to-stand test , MIP , MEP , and muscle strength were assessed before and after 24 training sessions .
-METHODS	Progressive resistance training was performed two times per week for a total of 8-12 repetitions , using the main muscle groups of the upper and lower limbs .
-RESULTS	The main results showed that the participants significantly increased their MEP ( P < 0.05 ; 1-SET : 34.6 % ; 3-SET : 35.8 % ) and MIP ( P < 0.05 ; 1-SET : 13.7 % ; 3-SET : 11.2 % ) .
-RESULTS	Both groups also improved in the sit-to-stand test ( P < 0.05 ; 1-SET : 10.6 % ; 3-SET : 17.1 % ) .
-RESULTS	After 24 training sessions , muscle strength also significantly increased ( P < 0.0001 ; 40 % -80 % ) in both groups .
-RESULTS	An intergroup comparison did not show any statistically significant differences between the groups in any of the parameters analyzed .
-CONCLUSIONS	Single - and multiple-set resistance training programs increased MIP , MEP , muscle strength , and sit-to-stand test performance in elderly women after 24 sessions of training .
-CONCLUSIONS	In conclusion , our results suggested that elderly women who are not in the habit of physical activity may start with single-set resistance training programs as a short-term strategy for the maintenance of health .
-
-###25724455
-OBJECTIVE	Infliximab , a tumor necrosis factor antagonist , is effective for treating patients with Crohn 's disease ( CD ) and ulcerative colitis ( UC ) .
-OBJECTIVE	We aimed to determine whether dosing based on therapeutic drug monitoring increases rate of remission and whether continued concentration-based dosing is superior to clinically based dosing of infliximab for maintaining remission in patients with CD and UC .
-METHODS	We performed a 1-year randomized controlled trial at a tertiary referral center , including 263 adults ( 178 with CD and 85 with UC ) with stable responses to maintenance infliximab therapy .
-METHODS	Doses were escalated or reduced using an algorithm to reach a target trough concentration ( TC ) of 3-7 g/mL in all patients ( optimization phase ) .
-METHODS	Patients were randomly assigned ( 1:1 ) to groups that received infliximab dosing based on their clinical features ( n = 123 ) or continued dosing based on TCs ( n = 128 ) ( maintenance phase ) .
-METHODS	The primary end point was clinical and biochemical remission at 1 year after the optimization phase .
-RESULTS	At screening , 115 of 263 patients had a TC of infliximab of 3-7 g/mL ( 43.7 % ) .
-RESULTS	Of 76 patients with TCs < 3 g/mL , 69 patients ( 91 % ) achieved TCs of 3-7 g/mL after dose escalation .
-RESULTS	This resulted in a higher proportion of CD patients in remission than before dose escalation ( 88 % vs 65 % ; P = .020 ) and a decrease in the median concentration of C-reactive protein , compared with before the dose increase ( 3.2 vs 4.3 mg/L ; P < .001 ) ; these changes were not observed in patients with UC .
-RESULTS	Of 72 patients with TCs > 7 g/mL , 67 patients ( 93 % ) achieved TCs of 3-7 g/mL after dose reduction .
-RESULTS	This resulted in a 28 % reduction in drug cost from before dose reduction ( P < .001 ) .
-RESULTS	Sixty-six percent of patients whose dosing was based on clinical features and 69 % whose dosing was based on TC achieved remission , the primary end point ( P = .686 ) .
-RESULTS	Disease relapsed in 21 patients who received clinically based dosing ( 17 % ) and 9 patients who received concentration-based dosing ( 7 % ) ( P = .018 ) .
-CONCLUSIONS	Targeting patients ' infliximab TCs to 3-7 g/mL results in a more efficient use of the drug .
-CONCLUSIONS	After dose optimization , continued concentration-based dosing was not superior to clinically based dosing for achieving remission after 1 year , but was associated with fewer flares during the course of treatment .
-CONCLUSIONS	ClinicalTrialsRegister.eu number : 2011-002061-38 .
-
-###24314835
-OBJECTIVE	To determine if volunteers can simulate and reproduce 3 types of neurologic field defects : hemianopia , quadrantanopia , and central scotoma .
-METHODS	Cross-sectional study .
-METHODS	Thirty healthy volunteers new to perimetry ( including automated perimetry ) .
-METHODS	After informed consent , volunteers were randomized to 1 of the 3 visual field defects listed above .
-METHODS	All visual field testing was performed on the right eye using the Humphrey Field Analyzer ( HFA ; Carl Zeiss Meditec , Dublin , CA ) SITA Fast 24-2 protocol .
-METHODS	Each volunteer was provided with standard new patient instructions and was shown a diagram of the defect to be simulated .
-METHODS	Two sets of visual fields were performed on the right eye with 10 minutes between tests .
-METHODS	Three experts used the Ocular Hypertension Treatment Study reading center criteria and determined if the simulation was successful .
-METHODS	Proportion of volunteers able to simulate the assigned visual field .
-RESULTS	All 10 volunteers ( 100 % ) successfully simulated a hemianopia on the first and second fields .
-RESULTS	All 10 volunteers ( 100 % ) simulated a quadrantanopia on the first field and 9 ( 90 % ) did so on the second field .
-RESULTS	Eight volunteers ( 80 % ) successfully simulated a central scotoma in the first field and all 10 ( 100 % ) did so on in the second field .
-RESULTS	Reliability criteria were excellent .
-RESULTS	Forty-seven fields ( 78 % ) had 0 fixation losses , 48 ( 80 % ) had 0 false-positive results , and 44 ( 73 % ) had 0 false-negative results .
-CONCLUSIONS	It is easy to simulate reproducible and reliable neurologic field defects on automated perimetry using HFA .
-
-###24525630
-BACKGROUND	The authors investigated the efficacy of bilateral suprazygomatic maxillary nerve block ( SMB ) for postoperative pain relief in infants undergoing cleft palate repair .
-METHODS	In this prospective , double-blind , single-site , randomized , and parallel-arm controlled trial , 60 children were assigned to undergo bilateral SMB with general anesthesia with either 0.15 ml/kg of 0.2 % ropivacaine ( Ropi group ) or 0.15 ml/kg of isotonic saline ( Saline group ) on each side .
-METHODS	The primary endpoint was total postoperative morphine consumption at 48 h. Pain scores and respiratory - and SMB-related complications were noted .
-RESULTS	The overall dose of intravenous morphine after 48 h ( mean [ 95 % CI ] ) was lower in the Ropi group compared with that in the Saline group ( 104.3 [ 68.9 to 139.6 ] vs. 205.2 [ 130.7 to 279.7 ] g/kg ; P = 0.033 ) .
-RESULTS	Continuous morphine infusion was less frequent in the Ropi group compared with that in the Saline group ( 1 patient [ 3.6 % ] vs. 9 patients [ 31 % ] ; P = 0.006 ) .
-RESULTS	Three patients in the Saline group had an episode of oxygen desaturation requiring oxygen therapy .
-RESULTS	There were no technical failures or immediate complications of the SMB .
-RESULTS	Intraoperative hemodynamic parameters , doses of sufentanil , pain scores , and postoperative hydroxyzine requirements were not different between the two groups .
-CONCLUSIONS	Bilateral SMB is an easy regional anesthesia technique that reduces total morphine consumption at 48 h after cleft palate repair in children and the use of continuous infusion of morphine and may decrease postoperative respiratory complications .
-
-###25355310
-OBJECTIVE	To evaluate the efficacy and safety of AVP-825 , a drug-device combination of low-dose sumatriptan powder ( 22mg loaded dose ) delivered intranasally through a targeted Breath Powered device vs an identical device containing lactose powder ( placebo device ) in the treatment of migraine headache .
-BACKGROUND	Early treatment of migraine headaches is associated with improved outcome , but medication absorption after oral delivery may be delayed in migraineurs because of reduced gastric motility .
-BACKGROUND	Sumatriptan powder administered with an innovative , closed-palate , Bi-Directional , Breath Powered intranasal delivery mechanism is efficiently absorbed across the nasal mucosa and produces fast absorption into the circulation .
-BACKGROUND	Results from a previously conducted placebo-controlled study of AVP-825 showed a high degree of headache relief with an early onset of action ( eg , 74 % AVP-825 vs 38 % placebo device at 1 hour , P < .01 ) .
-METHODS	In this double-blind , placebo-controlled , parallel-group study in adults with a history of migraine with or without aura , participants were randomized via computer-generated lists to AVP-825 or placebo device to treat a single migraine headache of moderate or severe intensity .
-METHODS	The primary endpoint was headache relief ( defined as reduction of headache pain intensity from severe or moderate migraine headache to mild or none ) at 2 hours post-dose .
-RESULTS	Two hundred and thirty patients ( 116 AVP-825 and 114 placebo device ) were randomized , of whom 223 ( 112 and 111 , respectively ) experienced a qualifying migraine headache ( their next migraine headache that reached moderate or severe intensity ) .
-RESULTS	A significantly greater proportion of AVP-825 patients reported headache relief at 2 hours post-dose compared with those using the placebo device ( 68 % vs 45 % , P = .002 , odds ratio 2.53 , 95 % confidence interval [ 1.45 , 4.42 ] ) .
-RESULTS	Between-group differences in headache relief were evident as early as 15 minutes , reached statistical significance at 30 minutes post-dose ( 42 % vs 27 % , P = .03 ) , and were sustained at 24 hours ( 44 % vs 24 % , P = .002 ) and 48 hours ( 34 % vs 20 % , P = .01 ) .
-RESULTS	Thirty-four percent of patients treated with AVP-825 were pain-free at 2 hours compared with 17 % using the placebo device ( P = .008 ) .
-RESULTS	More AVP-825 patients reported meaningful pain relief ( patient interpretation ) of migraine within 2 hours of treatment vs placebo device ( 70 % vs 45 % , P < .001 ) , and fewer required rescue medication ( 37 % vs 52 % , P = .02 ) .
-RESULTS	Total migraine freedom ( patients with no headache , nausea , phonophobia , photophobia , or vomiting ) reached significance following treatment with AVP-825 at 1 hour ( 19 % vs 9 % ; P = .04 ) .
-RESULTS	There were no serious adverse events ( AEs ) , and no systemic AEs occurred in more than one patient .
-RESULTS	Chest pain or pressure was not reported , and only one patient taking AVP-825 reported mild paresthesia .
-RESULTS	No other triptan sensations were reported .
-CONCLUSIONS	Targeted delivery of a low-dose of sumatriptan powder via a novel , closed-palate , Breath Powered , intranasal device ( AVP-825 ) provided fast relief of moderate or severe migraine headache in adults that reached statistical significance over placebo by 30 minutes .
-CONCLUSIONS	The treatment was well tolerated with a low incidence of systemic AEs .
-
-###25150159
-OBJECTIVE	To characterize the pharmacokinetics ( PK ) and pharmacodynamics ( PD ) of a new insulin glargine comprising 300 units mL ( -1 ) ( Gla-300 ) , compared with insulin glargine 100 units mL ( -1 ) ( Gla-100 ) at steady state in people with type 1 diabetes .
-METHODS	A randomized , double-blind , crossover study ( N = 30 ) was conducted , applying the euglycemic clamp technique over a period of 36 h.
-METHODS	In this multiple-dose to steady-state study , participants received once-daily subcutaneous administrations of either 0.4 ( cohort 1 ) or 0.6 units kg ( -1 ) ( cohort 2 ) Gla-300 for 8 days in one treatment period and 0.4 units kg ( -1 ) Gla-100 for 8 days in the other .
-METHODS	Here we focus on the results of a direct comparison between 0.4 units kg ( -1 ) of each treatment .
-METHODS	PK and PD assessments performed on the last treatment day included serum insulin measurements using a radioimmunoassay and the automated euglycemic glucose clamp technique over 36 h.
-RESULTS	At steady state , insulin concentration ( INS ) and glucose infusion rate ( GIR ) profiles of Gla-300 were more constant and more evenly distributed over 24 h compared with those of Gla-100 and lasted longer , as supported by the later time ( 3 h ) to 50 % of the area under the serum INS and GIR time curves from time zero to 36 h post dosing .
-RESULTS	Tight blood glucose control ( 105 mg dL ( -1 ) ) was maintained for approximately 5 h longer ( median of 30 h ) with Gla-300 compared with Gla-100 .
-CONCLUSIONS	Gla-300 provides more even steady-state PK and PD profiles and a longer duration of action than Gla-100 , extending blood glucose control well beyond 24 h.
-
-###26241253
-OBJECTIVE	To evaluate intramuscular ketorolac compared with placebo saline injection for pain control with intrauterine device ( IUD ) placement .
-METHODS	We conducted a randomized , double-blind , placebo-controlled trial between July 2012 and March 2014 .
-METHODS	Patients received 30 mg ketorolac or placebo saline intramuscular injection 30 minutes before IUD placement .
-METHODS	The primary outcome was pain with IUD placement on a 10-cm visual analog scale .
-METHODS	Sample size was calculated to provide 80 % power to show a 2.0-cm difference ( = 0.05 ) in the primary outcome .
-METHODS	Secondary outcomes included pain with study drug injection , speculum insertion , tenaculum placement , uterine sounding , and at 5 and 15 minutes after IUD placement .
-RESULTS	A total of 67 women participated in the study , 33 in the ketorolac arm and 34 in the placebo arm .
-RESULTS	There were no differences in baseline demographics including age , body mass index , and race .
-RESULTS	There were no differences in median pain scores for IUD placement in the placebo compared with ketorolac groups ( 5.2 compared with 3.6 cm , P = .99 ) .
-RESULTS	There was a decrease in median pain scores at 5 minutes ( 2.2 compared with 0.3 cm , P. 001 ) and 15 minutes ( 1.6 compared with 0.1 cm , P. 001 ) after IUD placement but no difference for all other time points .
-RESULTS	Nulliparous participants ( n = 16 , eight per arm ) had a decrease in pain scores with IUD placement ( 8.1 compared with 5.4 cm , P = .02 ) .
-RESULTS	In this study , 22 % of participants in the placebo group and 18 % in the ketorolac group reported injection pain was as painful as IUD placement .
-CONCLUSIONS	Ketorolac does not reduce pain with IUD placement but does reduce pain at 5 and 15 minutes after placement .
-BACKGROUND	ClinicalTrials.gov ; www.clinicaltrials.gov , NCT01664559 .
-METHODS	I.
-
-###25381300
-OBJECTIVE	To study activin signaling and its blockade in sporadic inclusion body myositis ( sIBM ) through translational studies and a randomized controlled trial .
-METHODS	We measured transforming growth factor signaling by SMAD2/3 phosphorylation in muscle biopsies of 50 patients with neuromuscular disease ( 17 with sIBM ) .
-METHODS	We tested inhibition of activin receptors IIA and IIB ( ActRII ) in 14 patients with sIBM using one dose of bimagrumab ( n = 11 ) or placebo ( n = 3 ) .
-METHODS	The primary outcome was the change in right thigh muscle volume by MRI at 8 weeks .
-METHODS	Lean body mass , strength , and function were secondary outcomes .
-METHODS	Twelve of the patients ( 10 bimagrumab , 2 placebo ) participated in a subsequent 16-week observation phase .
-RESULTS	Muscle SMAD2/3 phosphorylation was higher in sIBM than in other muscle diseases studied ( p = 0.003 ) .
-RESULTS	Eight weeks after dosing , the bimagrumab-treated patients increased thigh muscle volume ( right leg +6.5 % compared with placebo , p = 0.024 ; left leg +7.6 % , p = 0.009 ) and lean body mass ( +5.7 % compared with placebo , p = 0.014 ) .
-RESULTS	Subsequently , bimagrumab-treated patients had improved 6-minute walking distance , which peaked at 16 weeks ( +14.6 % , p = 0.008 ) compared with placebo .
-RESULTS	There were no serious adverse events ; the main adverse events with bimagrumab were mild acne and transient involuntary muscle contractions .
-CONCLUSIONS	Transforming growth factor superfamily signaling , at least through ActRII , is implicated in the pathophysiology of sIBM .
-CONCLUSIONS	Inhibition of ActRII increased muscle mass and function in this pilot trial , offering a potential novel treatment of sIBM .
-METHODS	This study provides Class I evidence that for patients with inclusion body myositis , bimagrumab increases thigh muscle volume at 8 weeks .
-
-###24559178
-BACKGROUND	Although dental care settings provide an exceptional opportunity to reach smokers and provide brief cessation advice and treatment to reduce oral and other tobacco-related health conditions , dental care providers demonstrate limited adherence to evidence-based guidelines for treatment of tobacco use and dependence .
-METHODS	Guided by a multi-level , conceptual framework that emphasizes changes in provider beliefs and organizational characteristics as drivers of improvement in tobacco treatment delivery , the current protocol will use a cluster , randomized design and multiple data sources ( patient exit interviews , provider surveys , site observations , chart audits , and semi-structured provider interviews ) to study the process of implementing clinical practice guidelines for treating tobacco dependence in 18 public dental care clinics in New York City .
-METHODS	The specific aims of this comparative-effectiveness research trial are to : compare the effectiveness of three promising strategies for implementation of tobacco use treatment guidelines-staff training and current best practices ( CBP ) , CBP + provider performance feedback ( PF ) , and CBP+PF + provider reimbursement for delivery of tobacco cessation treatment ( pay-for-performance , or P4P ) ; examine potential theory-driven mechanisms hypothesized to explain the comparative effectiveness of three strategies for implementation ; and identify baseline organizational factors that influence the implementation of evidence-based tobacco use treatment practices in dental clinics .
-METHODS	The primary outcome is change in providers ' tobacco treatment practices and the secondary outcomes are cost per quit , use of tobacco cessation treatments , quit attempts , and smoking abstinence .
-CONCLUSIONS	We hypothesize that the value of these promising implementation strategies is additive and that incorporating all three strategies ( CBP , PF , and P4P ) will be superior to CBP alone and CBP+PF in improving delivery of cessation assistance to smokers .
-CONCLUSIONS	The findings will improve knowledge pertinent to the implementation , dissemination , and sustained utilization of evidence-based tobacco use treatment in dental practices .
-BACKGROUND	NCT01615237 .
-
-###24875964
-METHODS	Multicenter , randomized , controlled trial on preoperative pain neuroscience education ( NE ) for lumbar radiculopathy .
-OBJECTIVE	To determine if the addition of NE to usual preoperative education would result in superior outcomes with regard to pain , function , surgical experience , and health care utilization postsurgery .
-BACKGROUND	One in 4 patients after lumbar surgery ( LS ) for radiculopathy experience persistent pain and disability , which is nonresponsive to perioperative treatments .
-BACKGROUND	NE focusing on the neurophysiology of pain has been shown to decrease pain and disability in populations with chronic low back pain .
-METHODS	Eligible patients scheduled for LS for radiculopathy were randomized to receive either preoperative usual care ( UC ) or a combination of UC plus 1 session of NE delivered by a physical therapist ( verbal one-on-one format ) and a NE booklet .
-METHODS	Sixty-seven patients completed the following outcomes prior to LS ( baseline ) , and 1 , 3 , 6 , and 12 months after LS : low back pain ( numeric rating scale ) , leg pain ( numeric rating scale ) , function ( Oswestry Disability Index ) , various beliefs and experiences related to LS ( 10-item survey with Likert scale responses ) , and postoperative utilization of health care ( utilization of health care questionnaire ) .
-RESULTS	At 1-year follow-up , there were no statistical differences between the experimental and control groups with regard to primary outcome measure of low back pain ( P = 0.183 ) , leg pain ( P = 0.075 ) , and function ( P = 0.365 ) .
-RESULTS	In a majority of the categories regarding surgical experience , the NE group scored significantly better : better prepared for LS ( P = 0.001 ) ; preoperative session preparing them for LS ( P < 0.001 ) and LS meeting their expectations ( P = 0.021 ) .
-RESULTS	Health care utilization post-LS also favored the NE group ( P = 0.007 ) resulting in 45 % less health care expenditure compared with the control group in the 1-year follow-up period .
-CONCLUSIONS	NE resulted in significant behavior change .
-CONCLUSIONS	Despite a similar pain and functional trajectory during the 1-year trial , patients with LS who received NE viewed their surgical experience more favorably and used less health care facility in the form of medical tests and treatments .
-METHODS	2 .
-
-###25005057
-OBJECTIVE	To compare extra-abdominal repair of the uterine incision at cesarean delivery with in situ repair .
-METHODS	The present study was a double-blind randomized controlled trial conducted at a university hospital in Egypt during 2012-2013 , and included women with an indication for cesarean delivery .
-METHODS	Extra-abdominal repair was used in group 1 ( n = 500 ) and in situ repair in group 2 ( n = 500 ) .
-METHODS	The primary outcome measure was the surgery duration .
-RESULTS	Surgery duration was significantly longer in group 1 than group 2 ( 49.92.3 minutes vs 39.91.8 minutes ; P < 0.001 ) .
-RESULTS	More patients in group 1 than in group 2 had postoperative moderate-to-severe pain ( 165 [ 33.0 % ] vs 115 [ 23.0 % ] ; P = 0.001 ) and needed additional postoperative analgesia ( 100 [ 20.0 % ] vs 50 [ 10.0 % ] ; P < 0.001 ) .
-RESULTS	Moreover , mean time to bowel movement was longer in group 1 than in group 2 ( 17.02.7 hours vs 14.01.9 hours ; P < 0.001 ) .
-CONCLUSIONS	In situ uterine closure is more advantageous than extra-abdominal repair in terms of surgery duration , postoperative pain and need for additional analgesia , and return of bowel movement .
-CONCLUSIONS	ClinicalTrials.gov : NCT01723605 .
-
-###24685085
-OBJECTIVE	The aim of this study was to compare the efficacy of low molecular weight heparin ( LMWH ) combined with graduated compression stockings ( GCS ) with GCS alone as prophylactic measures for venous thromboembolism ( VTE ) in post-operative patients with gynecologic cancer .
-METHODS	Patients diagnosed with gynecologic cancer undergoing primary major surgery between 2010 and 2011 in our institute were randomized to receive LMWH+GCS or GCS as VTE prophylaxis post-operatively .
-RESULTS	Altogether 247 patients were enrolled .
-RESULTS	The incidence of VTE in patients treated with LMWH + GCS was significantly lower than that in patients using GCS alone ( 0.8 % Vs. 8.1 % , P = 0.01 ) .
-RESULTS	There were no severe bleeding complications in the patients with prophylactic use of LMWH and the occurrence rate of wound dehiscence was comparable between the two groups ( P > 0.05 ) .
-RESULTS	Multivariable logistic regression analysis revealed that age over 60 years ( P = 0.015 ) , duration of operation over 3 hours ( P = 0.04 ) and without prophylactic use of LMWH ( P = 0.02 ) were independent risk factors for VTE .
-CONCLUSIONS	Dual prophylaxis with LMWH and GCS should be recommended for gynecologic cancer patients undergoing major surgery for its better efficacy than GCS .
-CONCLUSIONS	Prophylactic use of LMWH is safe and convenient .
-CONCLUSIONS	Patients with older age and prolonged operation time are at highest risk of developing VTE post-operatively .
-
-###24598599
-OBJECTIVE	Until recently , very few intervention studies have investigated the effects of whole-grain cereals on postprandial glucose , insulin and lipid metabolism , and the existing studies have provided mixed results .
-OBJECTIVE	The objective of this study was to evaluate the effects of a 12-week intervention with either a whole-grain-based or a refined cereal-based diet on postprandial glucose , insulin and lipid metabolism in individuals with metabolic syndrome .
-RESULTS	Sixty-one men and women age range 40-65 years , with the metabolic syndrome were recruited to participate in this study using a parallel group design .
-RESULTS	After a 4-week run-in period , participants were randomly assigned to a 12-week diet based on whole-grain products ( whole-grain group ) or refined cereal products ( control group ) .
-RESULTS	Blood samples were taken at the beginning and end of the intervention , both fasting and 3 h after a lunch , to measure biochemical parameters .
-RESULTS	Generalized linear model ( GLM ) was used for between-group comparisons .
-RESULTS	Overall , 26 participants in the control group and 28 in the whole-grain group completed the dietary intervention .
-RESULTS	Drop-outs ( five in the control and two in the whole-grain group ) did not affect randomization .
-RESULTS	After 12 weeks , postprandial insulin and triglyceride responses ( evaluated as average change 2 and 3 h after the meal , respectively ) decreased by 29 % and 43 % , respectively , in the whole-grain group compared to the run-in period .
-RESULTS	Postprandial insulin and triglyceride responses were significantly lower at the end of the intervention in the whole-grain group compared to the control group ( p = 0.04 and p = 0.05 ; respectively ) whereas there was no change in postprandial response of glucose and other parameters evaluated .
-CONCLUSIONS	A twelve week whole-grain cereal-based diet , compared to refined cereals , reduced postprandial insulin and triglycerides responses .
-CONCLUSIONS	This finding may have implications for type 2 diabetes risk and cardiovascular disease .
-
-###25875256
-BACKGROUND	Oral ulcers , the hallmark of Behet 's syndrome , can be resistant to conventional treatment ; therefore , alternative agents are needed .
-BACKGROUND	Apremilast is an oral phosphodiesterase-4 inhibitor that modulates several inflammatory pathways .
-METHODS	We conducted a phase 2 , multicenter , placebo-controlled study in which 111 patients with Behet 's syndrome who had two or more oral ulcers were randomly assigned to receive 30 mg of apremilast twice daily or placebo for 12 weeks .
-METHODS	This regimen was followed by a 12-week extension phase in which the placebo group was switched to apremilast and a 28-day post-treatment observational follow-up phase .
-METHODS	The patients and clinicians were unaware of the study assignments throughout the trial .
-METHODS	The primary end point was the number of oral ulcers at week 12 .
-METHODS	Secondary outcomes included pain from these ulcers ( measured on a 100-mm visual-analogue scale , with higher scores indicating worse pain ) , the number of genital ulcers , overall disease activity , and quality of life .
-RESULTS	The mean ( SD ) number of oral ulcers per patient at week 12 was significantly lower in the apremilast group than in the placebo group ( 0.51.0 vs. 2.12.6 ) ( P < 0.001 ) .
-RESULTS	The mean decline in pain from oral ulcers from baseline to week 12 was greater with apremilast than with placebo ( -44.724.3 mm vs. -16.032.5 mm ) ( P < 0.001 ) .
-RESULTS	Nausea , vomiting , and diarrhea were more common in the apremilast group ( with 22 , 9 , and 12 incidents , respectively , among 55 patients ) than in the placebo group ( with 10 , 1 , and 2 incidents , respectively , among 56 patients ) , findings that were similar to those in previous studies of apremilast .
-RESULTS	There were two serious adverse events in patients receiving apremilast .
-CONCLUSIONS	Apremilast was effective in treating oral ulcers , which are the cardinal manifestation of Behet 's syndrome .
-CONCLUSIONS	This preliminary study was neither large enough nor long enough to assess long-term efficacy , the effect on other manifestations of Behet 's syndrome , or the risk of uncommon serious adverse events .
-CONCLUSIONS	( Funded by Celgene ; ClinicalTrials.gov number , NCT00866359 . )
-
-###25116277
-OBJECTIVE	Leg compression is considered basic treatment for superficial vein thrombosis ( SVT ) , although scientific proof for its efficacy is lacking .
-OBJECTIVE	The aim of the study was to evaluate the therapeutic effect of compression stockings on isolated SVT of the legs .
-METHODS	This was a single-center randomized controlled trial .
-METHODS	Eighty patients with isolated SVT of the legs were instructed to wear compression stockings ( 23-32mmHg ) ( CG ) or no compression ( NCG ) for 3 weeks .
-METHODS	All patients received low molecular weight heparin ( LMWH ) at prophylactic dosage .
-METHODS	Non-steroidal anti-inflammatory drugs ( NSAIDs ) were allowed .
-METHODS	The primary outcome variable was the reduction of pain as assessed by a visual analog scale ( VAS ) and the Lowenberg test .
-METHODS	Secondary outcomes were the consumption of analgesics , thrombus length , skin erythema , D-dimer , and quality of life ( QoL ) .
-RESULTS	Seventy-three patients completed the study .
-RESULTS	Clinical symptoms and QoL significantly improved from baseline to day 21 in both groups ( p < .001 for VAS , Lowenberg test , thrombus length , and erythema ; p < .006 for QoL ) , and consumption of analgesics and D-dimer significantly decreased ( p < .001 ) .
-RESULTS	There was no significant difference between the groups for all tested variables .
-RESULTS	At day 7 , patients in the CG revealed a significantly faster thrombus regression ( p = .02 ) .
-CONCLUSIONS	Adding compression stockings for 3 weeks to LMWH and NSAIDs does not bring significant additional benefit in the treatment of isolated SVT .
-CONCLUSIONS	When worn for 1 week , compression stockings stimulate significantly faster thrombus regression .
-
-###24766353
-OBJECTIVE	Two reports of infants found dead after sleeping in baby hammocks have raised international concern about the safety of infant hammocks .
-OBJECTIVE	We therefore tested whether hammock sleep affected oxygenation in infants , when they were at an age of high risk of sudden , unexpected infant death .
-METHODS	Healthy , full-term 4 - to 8-week-old infants were randomised to sleep either in a commercially available hammock ( n = 14 ) or a standard bassinet ( n = 9 ) , and sleep state , oxygen desaturation ( a fall in peripheral haemoglobin oxygen saturation ( SpO2 ) 4 % , for 4 sec from baseline to nadir ) , apnoea and hypopnoea , and mean SpO2 were analysed .
-RESULTS	There was no significant difference in mean SpO2 ( both 98.5 % ) or rate of oxygen desaturation events between the hammock and the bassinet cot ( mean SD , 24 20 vs. 28 23 events per hour ) , but infants slept less in the hammock ( 59 31 vs. 81 34 min , p < 0.02 ) .
-CONCLUSIONS	When correctly used , the hammock sleep position did not compromise the upper airway of sleeping infants .
-CONCLUSIONS	The significance of shorter duration of sleep in the hammocks is unclear .
-CONCLUSIONS	These findings should not be applied to all baby hammocks , nor to older babies , particularly once the infant can roll .
-CONCLUSIONS	Given that it is not possible to predict when an infant will be able to roll , we strongly recommend that hammocks should not be used for unsupervised sleep .
-
-###24360173
-OBJECTIVE	To explore the effects of reconstructing method ( narrow gastric tube ( NGT ) versus whole stomach ( WS ) ) on health-related quality of life ( HRQL ) in patients during a 3-year follow-up .
-METHODS	In a prospective randomized single-center study from 2007 to 2008 , 104 patients underwent esophagectomy for cancer .
-METHODS	They were divided into NGT ( n = 52 ) and WS ( n = 52 ) groups .
-METHODS	To assess HRQL , a questionnaire in references to EORTC-QLQ-C30 and QLQ-OES18 was administered at 3 weeks , 6 months , 1 year , 2 year and 3 years post-operation .
-METHODS	Their clinical data were collected prospectively and follow-up was performed regularly .
-RESULTS	The patients in the NGT group reported significantly ( P < 0.05 ) better average scores of HRQL at both 6 months and 1 year.However , no significant difference in average scores of HRQL was found at 3 years .
-RESULTS	Patients in the NGT group reported significantly ( P < 0.05 ) better scores of reflux at 3 weeks , 6 months and 1 year.Nausea was the only item with significant difference on HRQL at 2 years and 3 years.No significant difference existed between two groups with regards to cumulative survival rate at 3 years .
-CONCLUSIONS	No significant difference existed between two groups with regards to cumulative survival rate at 3 years .
-CONCLUSIONS	The patients with gastric tube reconstruction after oncologic esophagectomy present better HRQL.Further studies are warranted to perform survival analysis beyond 3 year post-operation .
-
-###24337060
-OBJECTIVE	It was to test the validity and reliability of an online version of the Female Sexual Function Index ( FSFI ) .
-METHODS	An online version of the FSFI was compared to the pen and paper traditional version .
-METHODS	Physiotherapy students in three cities were randomly allocated to two groups - G-pp/ol ( n = 126 ) and G-ol/pp ( n = 147 ) .
-METHODS	G-pp/ol women replied to th FSFI using the traditional pen and paper method , while G-ol/pp women answered an online version of the same questionnaire .
-METHODS	Data were collected ageing after 15 days , when G-pp/ol women answered the online version while G-ol/pp women answered on paper .
-METHODS	All data were transferred to SPSS software .
-METHODS	Demographic differences between the test two groups were determined by Student 's t-test or Fisher exact ( 95 % CI ; p > 0.05 ) .
-METHODS	Association and correlation between the responses of G-pp/ol and G-ol/pp were assessed for each sample by the t-test and Pearson 's coefficient .
-METHODS	An identical strategy was used for intragroup comparisons .
-RESULTS	A total of 273 women participated in the study and 28 ( 10.2 % ) giving up the second collection .
-RESULTS	There were no demographic differences between groups .
-RESULTS	Fifteen of the 19 FSFI questions were associated and correlated between the two groups in both test and the retest .
-RESULTS	The intragroup analysis revealed that all FSFI questions and scores were associated and weakly correlated for the same group during both test and retest .
-CONCLUSIONS	The online version of the FSFI showed acceptable validity and reliability when compared to the paper version , and can justify the choice of this modality , especially in studies involving private questions .
-
-###24607889
-OBJECTIVE	We aimed to compare the clinical outcomes of intra-articular calcaneus fractures treated with open reduction and internal fixation with conventional plate via L-shaped lateral approach ( routine treatment ) versus those with percutaneous plate via a sinus tarsi approach ( minimally invasive treatment ) .
-METHODS	One hundred and seventeen displaced intra-articular calcaneal fractures in 108 patients from January 2007 and September 2010 were randomly allocated to receive routine treatment ( 49 patients ) or minimally invasive treatment ( 59 patients ) .
-METHODS	Operative time , preoperative and postoperative calcaneal height , width , length , Bhlers angle , Gissanes angle , and incision healing were recorded .
-METHODS	Maryland foot score system was used to evaluate clinical functional outcomes .
-RESULTS	The operative time of minimally invasive group was significantly shorter than that of the routine group [ 46-80 min ( mean , 62 min ) vs 65-110 min ( mean , 93 min ) , p < 0.01 ] .
-RESULTS	Postoperative X-ray showed the calcaneal height , width , length , Bhlers angle and Gissanes angle were significantly improved in both two groups , and no significant difference was observed between two groups postoperatively .
-RESULTS	No feet developed wound complications in minimally invasive group , but incision complications occurred in 8 feet in routine group .
-RESULTS	The excellent and good rate according to the Maryland foot score was significantly higher in minimally invasive group than that in the routine group ( 93.8 % vs 86.8 % ) .
-CONCLUSIONS	Compared with L-shaped lateral approach treatment of displaced intra-articular calcaneal fractures , sinus tarsi approach for the reduction and internal fixation with percutaneous plate seems to be more safe and effective , with satisfactory clinical therapeutic effects and without postoperative complications .
-
-###25409678
-BACKGROUND	The incidence of acute kidney injury ( AKI ) is estimated at 10 to 20 % in patients admitted to intensive care units ( ICU ) and often requires renal replacement therapy ( RRT ) .
-BACKGROUND	ICU mortality in AKI patients can exceed 50 % .
-BACKGROUND	Venous catheters are the preferred vascular access method for AKI patients requiring RRT , but carry a risk of catheter thrombosis or infection .
-BACKGROUND	Catheter lock solutions are commonly used to prevent such complications .
-BACKGROUND	Heparin and citrate locks are both widely used for tunneled , long-term catheters , but few studies have compared citrate versus heparin for patients with short-term , non-tunneled catheters .
-BACKGROUND	We aim to compare citrate 4 % catheter lock solution versus heparin in terms of event-free survival of the first non-tunneled hemodialysis catheter inserted in ICU patients with AKI requiring RRT .
-BACKGROUND	Secondary objectives are the rate of fibrinolysis , incidence of catheter thrombosis and catheter-related infection per 1,000 catheter days , length of stay in ICU and in-hospital and 28-day mortality .
-METHODS	The VERROU-REA study is a randomized , prospective , multicenter , double-blind , parallel-group , controlled superiority study carried out in the medical , surgical and nephrological ICUs of two large university hospitals in eastern France .
-METHODS	A catheter lock solution composed of trisodium citrate at 4 % will be compared to unfractionated heparin at a concentration of 5,000 IU/mL .
-METHODS	All consecutive adult patients with AKI requiring extracorporeal RRT , and in whom a first non-tunneled catheter is to be inserted by the jugular or femoral approach , will be eligible .
-METHODS	Catheters inserted by the subclavian approach , patients with acute liver failure , thrombopenia or contraindication to systemic anticoagulation will be excluded .
-METHODS	Patients will be followed up daily in accordance with standard practices for RRT until death or discharge .
-CONCLUSIONS	Data is scarce regarding the use of non-tunneled catheters in the ICU setting in patients with AKI .
-CONCLUSIONS	This study will provide an evidence base for recommendations regarding the use of anticoagulant catheter locks for the prevention of dysfunction in non-tunneled hemodialysis catheters in patients with AKI in critical or intensive care .
-BACKGROUND	Registered with Clinicaltrials.gov ( registration number : NCT01962116 ) on 27 August 2013 .
-
-###24656704
-OBJECTIVE	This is a controlled , prospective study which compares the effects of a low-dose heat patch for self-medication on the reduction of pain symptoms in dysmenorrhea .
-METHODS	The sample group included female sophomore students studying at a university in Istanbul , Turkey , between 2007 and 2008 .
-METHODS	These female participants completed the Dysmenorrhea Identification Form to determine the sample group , and a total of 193 female students possessed the eligible criteria .
-METHODS	The research control group consisted of 66 patients , the analgesia group consisted of 61 , and the heat patch group consisted of 66 .
-METHODS	The control group did not use any treatments , while the self-medication group used analgesic medication ( single dose ) , and the heat patch group applied a heat patch on the lower abdomen , against the skin , for an application period of 2 menstrual cycles .
-METHODS	Using a visual analog scale ( VAS ) , the pain severity was recorded at the baseline , after 4 hours of intervention , and after 8 hours of intervention .
-METHODS	The data were examined using ANOVA .
-RESULTS	There were significant differences between the groups in terms of pain severity after 8 hours of application ( P < .001 ) .
-RESULTS	All groups had similar pain levels at baseline and during the fourth and eighth hours , with no significant differences between the groups during the first and the second menstrual cycles ( P > .05 ) .
-CONCLUSIONS	The authors conclude that the heat patch is an effective method for reducing dysmenorrhea .
-
-###24670297
-BACKGROUND	Paradoxically , a breast cancer risk reduction with conjugated equine estrogens ( CEE ) and a risk elevation with CEE plus medroxyprogesterone acetate ( CEE+MPA ) were observed in the Women 's Health Initiative ( WHI ) randomized controlled trials .
-BACKGROUND	The effects of hormone therapy on serum sex hormone levels , and on the association between baseline sex hormones and disease risk , may help explain these divergent breast cancer findings .
-METHODS	Serum sex hormone concentrations were measured for 348 breast cancer cases in the CEE+MPA trial and for 235 cases in the CEE trial along with corresponding pair-matched controls , nested within the WHI trials of healthy postmenopausal women .
-METHODS	Association and mediation analyses , to examine the extent to which sex hormone levels and changes can explain the breast cancer findings , were conducted using logistic regression .
-RESULTS	Following CEE treatment , breast cancer risk was associated with higher concentrations of baseline serum estrogens , and with lower concentrations of sex hormone binding globulin .
-RESULTS	However , following CEE+MPA , there was no association of breast cancer risk with baseline sex hormone levels .
-RESULTS	The sex hormone changes from baseline to year 1 provided an explanation for much of the reduced breast cancer risk with CEE .
-RESULTS	Specifically , the treatment odds ratio ( 95 % confidence interval ) increased from 0.71 ( 0.43 , 1.15 ) to 0.92 ( 0.41 , 2.09 ) when the year 1 measures were included in the logistic regression analysis .
-RESULTS	In comparison , the CEE+MPA odds ratio was essentially unchanged when these year 1 measures were included .
-CONCLUSIONS	Breast cancer risk remains low following CEE use among women having favorable baseline sex hormone profiles , but CEE+MPA evidently produces a breast cancer risk for all women similar to that for women having an unfavorable baseline sex hormone profile .
-CONCLUSIONS	These patterns could reflect breast ductal epithelial cell stimulation by CEE+MPA that is substantially avoided with CEE , in conjunction with relatively more favorable effects of either regimen following a sustained period of estrogen deprivation .
-CONCLUSIONS	These findings may have implications for other hormone therapy formulations and routes of delivery .
-BACKGROUND	clinicaltrials.gov identifier : NCT00000611 .
-
-###25184356
-OBJECTIVE	Cerebral autosomal-dominant arteriopathy with subcortical infarcts and leukoencephalopathy ( CADASIL ) , a rare autosomal dominant disorder caused by NOTCH3 mutations , is characterized by vascular smooth muscle and endothelial cells abnormalities , altered vasoreactivity , and recurrent lacunar infarcts .
-OBJECTIVE	Vasomotor function may represent a key factor for disease progression .
-OBJECTIVE	Tetrahydrobiopterin , essential cofactor for nitric oxide synthesis in endothelial cells , ameliorates endothelial function .
-OBJECTIVE	We assessed whether supplementation with sapropterin , a synthetic tetrahydrobiopterin analog , improves endothelium-dependent vasodilation in CADASIL patients .
-METHODS	In a 24-month , multicenter randomized , double-blind , placebo-controlled trial , CADASIL patients aged 30 to 65 years were randomly assigned to receive placebo or sapropterin 200 to 400 mg BID .
-METHODS	The primary end point was change in the reactive hyperemia index by peripheral arterial tonometry at 24 months .
-METHODS	We also assessed the safety and tolerability of sapropterin .
-METHODS	Analysis was done by intention-to-treat .
-RESULTS	The intention-to-treat population included 61 patients .
-RESULTS	We found no significant difference between sapropterin ( n = 32 ) and placebo ( n = 29 ) in the primary end point ( mean difference in reactive hyperemia index by peripheral arterial tonometry changes 0.19 [ 95 % confidence interval , -0.18 , 0.56 ] ) .
-RESULTS	Reactive hyperemia index by peripheral arterial tonometry increased after 24 months in 37 % of patients on sapropterin and in 28 % on placebo ; however , after adjustment for age , sex , and clinical characteristics , improvement was not associated with treatment arm .
-RESULTS	The proportion of patients with adverse events was similar on sapropterin and on placebo ( 50 % versus 48.3 % ) ; serious adverse events occurred in 6.3 % versus 13.8 % , respectively .
-CONCLUSIONS	Sapropterin was safe and well-tolerated at the average dose of 5 mg/kg/day , but did not affect endothelium-dependent vasodilation in CADASIL patients .
-BACKGROUND	https://www.clinicaltrialsregister.eu .
-BACKGROUND	Unique identifier : 2007-004370-55 .
-
-###24322060
-OBJECTIVE	Community-based efforts to prevent adolescent problem behaviors are essential to promote public health and achieve collective impact community wide .
-OBJECTIVE	OBJECTIVE To test whether the Communities That Care ( CTC ) prevention system reduced levels of risk and adolescent problem behaviors community wide 8 years after implementation of CTC .
-METHODS	A community-randomized trial was performed in 24 small towns in 7 states , matched within state , assigned randomly to a control or intervention group in 2003 .
-METHODS	All fifth-grade students attending public schools in study communities in 2003-2004 who received consent from their parents to participate ( 76.4 % of the eligible population ) were included .
-METHODS	A panel of 4407 fifth graders was surveyed through 12th grade , with 92.5 % of the sample participating at the last follow-up .
-METHODS	A coalition of community stakeholders received training and technical assistance to install CTC , used epidemiologic data to identify elevated risk factors and depressed protective factors for adolescent problem behaviors in the community , and implemented tested and effective programs for youths aged 10 to 14 years as well as their families and schools to address their community 's elevated risks .
-METHODS	MAIN OUTCOMES AND MEASURES Levels of targeted risk ; sustained abstinence , and cumulative incidence by grade 12 ; and current prevalence of tobacco , alcohol , and other drug use , delinquency , and violence in 12th grade .
-RESULTS	By spring of 12th grade , students in CTC communities were more likely than students in control communities to have abstained from any drug use ( adjusted risk ratio [ ARR ] = 1.32 ; 95 % CI , 1.06-1 .63 ) , drinking alcohol ( ARR = 1.31 ; 95 % CI , 1.09-1 .58 ) , smoking cigarettes ( ARR = 1.13 ; 95 % CI , 1.01-1 .27 ) , and engaging in delinquency ( ARR = 1.18 ; 95 % CI , 1.03-1 .36 ) .
-RESULTS	They were also less likely to ever have committed a violent act ( ARR = 0.86 ; 95 % CI , 0.76-0 .98 ) .
-RESULTS	There were no significant differences by intervention group in targeted risks , the prevalence of past-month or past-year substance use , or past-year delinquency or violence .
-CONCLUSIONS	Using the CTC system continued to prevent the initiation of adolescent problem behaviors through 12th grade , 8 years after implementation of CTC and 3 years after study-provided resources ended , but did not produce reductions in current levels of risk or current prevalence of problem behavior in 12th grade .
-CONCLUSIONS	TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT01088542 .
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-###24634923
-OBJECTIVE	In some randomized controlled trials laparoscopic cholecystectomy ( LC ) for acute cholecystitis was associated with a shorter hospital stay when compared with open cholecystectomy ( OC ) .
-OBJECTIVE	These studies were not double blinded and without intention to treat purpose .
-METHODS	The present study project was a prospective , randomized investigation .
-METHODS	The study was performed in the Department of General , Emergency and Transplant Surgery St Orsola-Malpighi University Hospital ( Bologna , Italy ) .
-METHODS	Subjects were divided in two groups : in the first group the patient was submitted to LC while in the second group was submitted to OC .
-RESULTS	Of 164 consecutive patients , 20 were excluded from the study .
-RESULTS	The two groups were similar in demographic and clinical characteristics .
-RESULTS	Seven ( 9.7 % ) patients in the LC group required conversion to OC .
-RESULTS	There were no deaths or bile duct lesions in either group , and the postoperative complication rate was similar ( p = n.s. ) .
-RESULTS	The mean postoperative hospital stay was also comparable .
-CONCLUSIONS	Even though LC for acute and gangrenous cholecystitis is technically demanding , in experienced hands it is safe and effective .
-CONCLUSIONS	It does not increase the mortality and the morbidity rate with a low conversion rate and no difference in hospital stay .
-
-###24332577
-BACKGROUND	The role of three factors in drinking outcome after brief intervention among heavily drinking HIV patients were investigated : strength of commitment to change drinking , alcohol dependence , and treatment type : brief Motivational Interview ( MI ) only , or MI plus HealthCall , a technological extension of brief intervention .
-METHODS	HIV primary care patients ( N = 139 ) who drank 4 drinks at least once in the 30 days before study entry participated in MI-only or MI+H ealthCall in a randomized trial to reduce drinking .
-METHODS	Patients were 95.0 % minority ; 23.0 % female ; 46.8 % alcohol dependent ; mean age 46.3 .
-METHODS	Outcome at end of treatment ( 60 days ) was drinks per drinking day ( Timeline Follow-Back ) .
-METHODS	Commitment strength ( CS ) was rated from MI session recordings .
-RESULTS	Overall , stronger CS predicted end-of-treatment drinking ( p < .001 ) .
-RESULTS	After finding an interaction of treatment , CS and alcohol dependence ( p = .01 ) , we examined treatmentCS interactions in alcohol dependent and non-dependent patients .
-RESULTS	In alcohol dependent patients , the treatmentcommitment strength interaction was significant ( p = .006 ) ; patients with low commitment strength had better outcomes in MI+H ealthCall than in MI-only ( lower mean drinks per drinking day ; 3.5 and 4.6 drinks , respectively ) .
-RESULTS	In non-dependent patients , neither treatment nor CS predicted outcome .
-CONCLUSIONS	Among alcohol dependent HIV patients , HealthCall was most beneficial in drinking reduction when MI ended with low commitment strength .
-CONCLUSIONS	HealthCall may not merely extend MI effects , but add effects of its own that compensate for low commitment strength .
-CONCLUSIONS	Thus , HealthCall may also be effective when paired with briefer interventions requiring less skill , training and supervision than MI .
-CONCLUSIONS	Replication is warranted .
-
-###24612164
-OBJECTIVE	To evaluate the effectiveness of the Healthy School and Drugs programme on alcohol , tobacco and marijuana use among Dutch early adolescents .
-METHODS	Randomized clustered trial with two intervention conditions ( i.e. e-learning and integral ) .
-METHODS	General population of 11-15-year-old adolescents in the Netherlands .
-METHODS	A total of 3784 students of 23 Dutch secondary schools .
-METHODS	Structured digital questionnaires were administered pre-intervention and at 32 months follow-up .
-METHODS	The primary outcome measures were new incidences of alcohol ( life-time and 1-month prevalence ) , tobacco ( life-time and 1-month prevalence ) and marijuana use ( life-time prevalence ) .
-RESULTS	Main effect analyses showed no programme effects on incidences of alcohol consumption ( life-time prevalence : e-learning condition : B = 0.102 , P = 0.549 ; integral condition : B = -0.157 , P = 0.351 ; 1-month prevalence : e-learning condition : B = 0.191 , P = 0.288 ; integral condition : B = -0.140 , P = 0.445 ) , tobacco consumption ( life-time prevalence : e-learning condition : B = 0.164 , P = 0.444 ; integral condition : B = 0.160 , P = 0.119 ; 1-month prevalence : e-learning condition : B = 0.088 , P = 0.746 ; integral condition : B = 0.261 , P = 0.093 ) , or marijuana consumption ( life-time prevalence : e-learning condition : B = 0.070 , P = 0.732 ; integral condition : B = 0.186 , P = 0.214 ) .
-CONCLUSIONS	The non-significant impact of the Healthy School and Drugs programme ( a Dutch school-based prevention programme for early adolescents ) on incidences of alcohol , tobacco and marijuana use indicates that the programme is either ineffective or implemented inadequately .
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-###24767575
-BACKGROUND	Esophageal resection is associated with a high incidence of postoperative pneumonia .
-BACKGROUND	Respiratory complications account for almost half of the readmissions to the critical care unit .
-BACKGROUND	Postoperative complications can result in prolonged hospital stay and consequently increase healthcare costs .
-BACKGROUND	In cardiac surgery a preoperative inspiratory muscle training program has shown to prevent postoperative pneumonia and reduce length of hospital stay .
-BACKGROUND	While in some surgical centers inspiratory muscle training is already used in the preoperative phase in patients undergoing esophageal resection , the added value of this intervention on the reduction of pulmonary complications has not yet been investigated in large surgical populations other than cardiac surgery in a randomized and controlled study design .
-METHODS	The effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection will be studied in a single blind multicenter randomized controlled trial ( the PREPARE study ) .
-METHODS	In total 248 patients ( age > 18years ) undergoing esophageal resection for esophageal cancer will be included in this study .
-METHODS	They are randomized to either usual care or usual care with an additional inspiratory muscle training intervention according to a high-intensity protocol which is performed with a tapered flow resistive inspiratory loading device .
-METHODS	Patients have to complete 30 dynamic inspiratory efforts twice daily for 7days a week until surgery with a minimum of 2weeks .
-METHODS	The starting training load will be aimed to be 60 % of maximal inspiratory pressure and will be increased based on the rate of perceived exertion.The main study endpoint is the incidence of postoperative pneumonia .
-METHODS	Secondary objectives are to evaluate the effect of preoperative inspiratory muscle training on length of hospital stay , duration of mechanical ventilation , incidence of other postoperative ( pulmonary ) complications , quality of life , and on postoperative respiratory muscle function and lung function .
-CONCLUSIONS	The PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection .
-BACKGROUND	NCT01893008 .
-
-###24957569
-OBJECTIVE	Few data are available on the influence of a colonoscope length for trainees , which could affect both the duration of training and colonoscopy quality .
-OBJECTIVE	We conducted this study to validate which scope needs more duration for training to reach technical competence and to shows better quality indicators during diagnostic colonoscopy .
-METHODS	We conducted a prospective randomly assigned study from April 2010 to February 2011 at Asan Medical Center .
-METHODS	Among the 1329 patients enrolled , 1200 colonoscopies were analyzed .
-METHODS	We compared cecal intubation rate , adenoma detection rate , cecal intubation time ( < 20 min ) , and withdrawal time between the trainees using the intermediate-length colonoscope and those using long-length colonoscope .
-RESULTS	Trainees who used the long-length colonoscope showed a higher overall cecal intubation rate ( 88.2 % vs. 81.0 % , p = 0.001 ) and adenoma detection rate ( 49.7 % vs. 34.2 % , p < 0.001 ) than those using the intermediate-length colonoscope .
-RESULTS	The successful cecal intubation rate improved significantly and reached the requisite standard of competence ( > 90 % ) after 90 procedures in the long-length colonoscope group .
-RESULTS	However , the trainees using the intermediate-length colonoscope reached the requisite standard of competence after 150 procedures .
-RESULTS	Logistic regression analysis revealed that prolonged cecal intubation was associated with the use of the intermediate-length colonoscope , poor colon preparation , a small number of esophagastroduodenoscopy or sigmoidoscopy procedures conducted , and pain during procedures .
-CONCLUSIONS	During the same training period , use of the long-length colonoscope in trainee was better in terms of reaching competency and quality indicators , and was less painful for the patients during colonoscopic procedures .
-
-###24424076
-OBJECTIVE	The current study was performed to investigate the effects of the Dietary Approaches to Stop Hypertension ( DASH ) eating plan on pregnancy outcomes in pregnant women with gestational diabetes mellitus ( GDM ) .
-METHODS	This randomized controlled clinical trial was performed among 52 women diagnosed with GDM .
-METHODS	Participants were randomly assigned to consume either the control ( n = 26 ) or the DASH diet ( n = 26 ) for 4 weeks .
-METHODS	The control diet was designed to contain 45-55 % carbohydrates , 15-20 % protein and 25-30 % total fat .
-METHODS	The DASH diet was rich in fruits , vegetables , whole grains and low-fat dairy products , and contained lower amounts of saturated fats , cholesterol and refined grains with a total of 2400 mg/day sodium .
-METHODS	The numbers of women who commenced insulin therapy after dietary intervention , the mode of delivery and prevalence of polyhydramnios were assessed .
-METHODS	The length , weight and head circumference of infants were measured during the first 24 h after birth .
-RESULTS	Whereas 46.2 % of women in the DASH diet needed to have a cesarean section , this percentage for the control group was 80.8 % ( P = 0.01 ) .
-RESULTS	The percentage of those who needed to commence insulin therapy after intervention was also significantly different between the two groups ( 23 % for DASH vs 73 % for control group , P < 0.0001 ) .
-RESULTS	Infants born to mothers on the DASH diet had significantly lower weight ( 3222.7 vs 3818.8 g , P < 0.0001 ) , head circumference ( 34.2 vs 35.1 cm , P = 0.01 ) and ponderal index ( 2.50 vs 2.87 kg/m ( 3 ) , P < 0.0001 ) compared with those born to mothers on the control diet .
-CONCLUSIONS	In conclusion , consumption of DASH diet for 4 weeks among pregnant women with GDM resulted in improved pregnancy outcomes .
-
-###25111822
-OBJECTIVE	Functional near-infrared spectroscopy ( fNIRS ) is an emerging technique for the in vivo assessment of functional activity of the cerebral cortex as well as in the field of brain-computer interface ( BCI ) research .
-OBJECTIVE	A common challenge for the utilization of fNIRS in these areas is a stable and reliable investigation of the spatio-temporal hemodynamic patterns .
-OBJECTIVE	However , the recorded patterns may be influenced and superimposed by signals generated from physiological processes , resulting in an inaccurate estimation of the cortical activity .
-OBJECTIVE	Up to now only a few studies have investigated these influences , and still less has been attempted to remove/reduce these influences .
-OBJECTIVE	The present study aims to gain insights into the reduction of physiological rhythms in hemodynamic signals ( oxygenated hemoglobin ( oxy-Hb ) , deoxygenated hemoglobin ( deoxy-Hb ) ) .
-METHODS	We introduce the use of three different signal processing approaches ( spatial filtering , a common average reference ( CAR ) method ; independent component analysis ( ICA ) ; and transfer function ( TF ) models ) to reduce the influence of respiratory and blood pressure ( BP ) rhythms on the hemodynamic responses .
-RESULTS	All approaches produce large reductions in BP and respiration influences on the oxy-Hb signals and , therefore , improve the contrast-to-noise ratio ( CNR ) .
-RESULTS	In contrast , for deoxy-Hb signals CAR and ICA did not improve the CNR .
-RESULTS	However , for the TF approach , a CNR-improvement in deoxy-Hb can also be found .
-CONCLUSIONS	The present study investigates the application of different signal processing approaches to reduce the influences of physiological rhythms on the hemodynamic responses .
-CONCLUSIONS	In addition to the identification of the best signal processing method , we also show the importance of noise reduction in fNIRS data .
-
-###25782319
-OBJECTIVE	To study effect of combined therapy with amlodipine with ramipril on the circadian profile of arterial pressure in patients with arterial hypertension in the Far North depending on the shiftwork regime .
-METHODS	130 patients with grade 2-3 AH were divided into 2 groups depending on the work-time schedule .
-METHODS	Group 1 included 67 daywork patients group 2 consisted of 63 patients working in the alternating daywork and nightwork regime .
-METHODS	24 hr AH monitoring was performed before , 4 weeks and 6 months after the onset of the study .
-RESULTS	Six months after the onset of therapy practically all patients reached the target AD level ( 94.4 % in group 1 and 94.7 % in group ) .
-RESULTS	The patients fairly well tolerated therapy AD circadian profile was normalized 1.9 times in group 1 and 3.2 times in group 2 .
-RESULTS	Recovered AP variability in group 1 resulted in a decreased frequency of target organ affection .
-RESULTS	In group 2 , the initially higher variability accounted for the normalization of only diastolic AP variability after 6 month therapy .
-RESULTS	It suggests the necessity of prescription of a third anti-AH preparation to these patients .
-RESULTS	Morning AP dynamics improved in both groups .
-
-###24702612
-OBJECTIVE	To ( 1 ) develop a model of cyclical adduction force on an abducted left arytenoid cartilage that mimics swallowing or coughing ; ( 2 ) determine if arytenoid abduction by a clamp before knot tying will improve the maintenance of abduction under cyclical adduction testing .
-METHODS	Experimental .
-METHODS	Cadaveric equine larynges ( n = 14 ) .
-METHODS	Left laryngoplasty performed using a single suture of # 5 Ethibond with ( n = 7 ) and without ( n = 7 ) abducting the arytenoid with a clamp before knot tying .
-METHODS	Each laryngoplasty was loaded cyclically from 2 to 26N at 0.5 Hz for 5000 cycles in a servohydraulic test frame .
-METHODS	Arytenoid displacement data were collected at 1Hz intervals and median percent loss of abduction compared between groups .
-METHODS	Significance was set at P < .05 .
-RESULTS	Median left arytenoid abduction distance was 16.9 mm ( range , 9.8-19 .8 mm ) .
-RESULTS	One larynx in each group failed at < 1000 cycles .
-RESULTS	Loss of abduction was determined by progressive displacement of the testing actuator and confirmed by measurement .
-RESULTS	There was no difference in loss of abduction between clamped and non-clamped larynges after 5000 cycles .
-RESULTS	This model of cyclical adduction resulted in arytenoid displacements similar to those seen in the 1st week postoperatively .
-CONCLUSIONS	Ex vivo cyclical adductory forces produced a significant loss of laryngoplasty abduction .
-CONCLUSIONS	The use of a clamp to abduct the arytenoid cartilage before knot tying did not reduce the loss of abduction .
-
-###25226015
-OBJECTIVE	To assess the potential efficacy , safety , and optimal dosing concentration of tavaborole , a novel , boron-based pharmaceutical agent with broad-spectrum antifungal activity , for the treatment of onychomycosis of the toenail due to dermatophytes .
-METHODS	One double-blind , randomized , vehicle-controlled study ( study 1 ) and two open-label studies ( studies 2 and 3 ) examined the efficacy , safety , and optimal dosing concentration of tavaborole topical solution applied once daily or three times weekly for 180 days at concentrations of 1.0 % , 2.5 % , 5.0 % , or 7.5 % .
-METHODS	Patient cohort 3 of study 2 received open-label tavaborole 5.0 % once daily for 360 days .
-METHODS	All three studies assessed day 180 treatment success , defined as complete or partial clinical evidence of clear nail growth plus negative fungal culture .
-RESULTS	A total of 336 patients were included in the intent-to-treat ( ITT ) or modified ITT populations and efficacy analyses across the 3 studies .
-RESULTS	In study 1 , treatment success rates at day 180 were higher with tavaborole 2.5 % , 5.0 % , and 7.5 % vs vehicle ( 27 % , 26 % , and 32 % vs 14 % , respectively ; slope P = 0.030 ) .
-RESULTS	In cohort 3 of study 2 , 7 % of patients achieved treatment success with tavaborole 5.0 % at day 360 .
-RESULTS	Negative culture rates at day 180 in study 1 were numerically higher for tavaborole 2.5 % , 5.0 % , and 7.5 % vs vehicle ( slope P = 0.046 ) .
-RESULTS	Application-site reactions of general irritation , erythema , scaling , and stinging/burning were most common with tavaborole 7.5 % , were generally mild to moderate , and resolved with treatment discontinuation and/or a reduction in dosing frequency .
-RESULTS	No systemic safety concerns were observed .
-CONCLUSIONS	Tavaborole solution demonstrated favorable efficacy and safety in phase 2 clinical studies .
-CONCLUSIONS	Based on these findings , tavaborole topical solution , 5 % was further investigated in larger , more definitive phase 3 studies .
-CONCLUSIONS	Results from these completed phase 3 studies will provide additional evidence regarding the safety and efficacy of tavaborole in the treatment of toenail onychomycosis .
-
-###24650164
-BACKGROUND	Evidence about long-term effects of preventive health services for youth with complex needs is lacking .
-BACKGROUND	Prime Time , a youth development intervention , aims to reduce pregnancy risk among vulnerable adolescent females seeking clinic services .
-METHODS	In a randomized trial , 253 sexually active females aged 13-17 who were at high risk for pregnancy were assigned to the Prime Time intervention or usual clinic services .
-METHODS	The 18-month intervention , initiated in 2007-2008 , comprised regular meetings with case managers and participation in youth leadership groups .
-METHODS	Trial participants completed surveys at baseline and 30 months .
-METHODS	Regression analyses were used to evaluate differences between groups in sexual and psychosocial outcomes at follow-up .
-RESULTS	At 30 months , the intervention group reported more months of consistent condom use ( adjusted means , 1.8 vs. 1.1 ) and dual contraceptive use ( 0.9 vs. 0.3 ) in the past seven months than did controls .
-RESULTS	The intervention was most effective in promoting consistent use among participants with relatively high levels of connectedness to family or school .
-RESULTS	Fifteen percent of intervention participants , but only 6 % of controls , reported having abstained from sex in the past six months ( adjusted odds ratio , 2.9 ) .
-RESULTS	Moreover , among high school graduates , those in the intervention group were more likely than those in the control group to have enrolled in college or technical school ( 72 % vs. 37 % ; odds ratio , 4.5 ) .
-CONCLUSIONS	Health services grounded in a youth development framework can lead to reductions in sexual risk among vulnerable youth that are evident one year following conclusion of services .
-
-###24786016
-OBJECTIVE	We aimed to investigate the population pharmacokinetics ( PK ) of soluble recombinant human tumor necrosis factor receptor fusion protein ( rhTNFR - Fc ) in Chinese patients with rheumatic arthritis ( RA ) .
-OBJECTIVE	The PK differences between Chinese patients with RA and healthy Chinese subjects were also compared .
-METHODS	40 patients were randomized to a single subcutaneous ( SC ) injections of 12.5 mg ( n = 10 ) , 25 mg ( n = 10 ) , and 50 mg ( n = 10 ) of rhTNFR-Fc , and six SC injection of rhTNFR - Fc at 25 mg once in 3 days ( n = 10 ) respectively .
-METHODS	A total of 550 serum concentration data points were collected in the RA patients .
-METHODS	The population PK analysis was performed by NONMEM .
-METHODS	Based on the population PK parameters obtained herein and those reported in healthy Chinese subjects , simulation was conducted to compare the difference of rhTNFR-Fc exposure between these populations .
-RESULTS	The PK data of Chinese patients with RA were best described by a one compartment model with lag time .
-RESULTS	A higher CL/F was noted in RA patients compared with that of the healthy Chinese subjects ( 1.64 L/h vs. 1.10 L/h ) , and a lower Ka was noticed in the RA patients compared with that of the healthy subjects ( 0.0317 h-1 vs. 0.0605 h-1 ) .
-RESULTS	The simulate results showed that rhTNFR-Fc exposure in Chinese patients with RA was significantly lower than that in healthy subjects .
-RESULTS	The mean patients/healthy subjects C ( max ) and AUC ( ss ) ratios were 0.870 and 0.890 , respectively .
-CONCLUSIONS	A population PK model of rhTNFR - Fc was developed in Chinese patients with RA .
-CONCLUSIONS	Statistical difference was noted in the PK of rhTNFR-Fc between Chinese patients with RA and healthy Chinese subjects .
-
-###25063041
-BACKGROUND	Korean red ginseng ( KRG ) is a processed ginseng from raw ginseng to enhance safety , preservation and efficacy , known having beneficial effects on women 's health due to its estrogen like function .
-BACKGROUND	While estrogen supplementation showed some modulation of endocrine disrupting chemicals , bisphenol A ( BPA ) has been focused as a potential endocrine disrupting chemical .
-BACKGROUND	In this study , we examined the efficacy and safety outcomes of KRG against BPA , focusing on female quality of life ( QOL ) .
-BACKGROUND	Individual variations in susceptibility to KRG were also investigated with the Sasang Typology , the personalized medicine used for hundred years in Korea .
-METHODS	We performed a single-blind randomized clinical trial .
-METHODS	Study subjects were young women ( N = 22 ) , consumed 2.7 g of KRG or placebo per day for 2 weeks and filled up questionnaires regarding gynecologic complaints at the 4 time spots .
-METHODS	We analyzed urinary total BPA and malondialdehyde ( MDA ) , an oxidative stress biomarker , with GC/MS and HPLC/UVD respectively , and diagnosed their Sasang Typology with the questionnaire for the Sasang constitution Classification ( QSCC II ) .
-RESULTS	KRG consumption decreased urinary BPA and MDA levels ( ps < 0.05 ) and alleviated ` menstrual irregularity ' , ` menstrual pain ' , and ` constipation ' ( ps < 0.05 ) .
-RESULTS	SoEum type ( Lesser Yin person ) among the Sasang types showed significant alleviation in insomnia , flushing , perspiration and appetite by KRG consumption , rather than other Sasang types .
-RESULTS	During the intervention , no one experienced any aggravated side effects .
-CONCLUSIONS	We suggest KRG is efficient for protection for female QOL and BPA - exposure and - related oxidative stress .
-CONCLUSIONS	However , individual variation in susceptibility to KRG should be further considered for identifying ideal therapy .
-BACKGROUND	KCT0000920 .
-
-###24939366
-OBJECTIVE	Conventional total uncinectomy may be unnecessary in localized maxillary sinus lesion .
-OBJECTIVE	Partial removal of the uncinate process and middle meatal antrostomy would be sufficient to eradicate the pathological condition .
-OBJECTIVE	Therefore , we aimed to evaluate the efficacy of partial uncinectomy versus total removal of the uncinate process in patients with localized maxillary sinus disease .
-METHODS	In total , 25 patients were assigned randomly to partial and total uncinectomy groups .
-METHODS	Preoperative computed tomography established that all patients had localized pathology in the maxillary sinus .
-METHODS	The lower half of the uncinate process was removed in the partial uncinectomy group , while the total uncinectomy group underwent the conventional surgery .
-METHODS	Time required for the uncinectomy , healing period for the uncinectomy site , incidence of lamina papyracea or nasolacrimal duct injury , obstruction or stenosis of the frontal recess , and incidence of synechia formation in the middle meatus were compared between the groups .
-RESULTS	All patients completed the follow-up and were included in the analysis .
-RESULTS	Surgical indications included chronic maxillary sinusitis , fungal sinusitis , antrochoanal polyp , and odontogenic sinusitis .
-RESULTS	Operation durations and healing periods were significantly shorter in the partial uncinectomy group .
-RESULTS	One patient had a minor injury to the lamina papyracea and two patients showed partial synechia formations in the total uncinectomy group .
-RESULTS	However , other parameters did not differ significantly between the groups .
-CONCLUSIONS	Partial uncinectomy may be useful in patients with pathological conditions confined to the maxillary sinus .
-CONCLUSIONS	Shorter operation duration , more rapid healing , and lower incidence of complications are advantages over a conventional total uncinectomy .
-
-###25012765
-BACKGROUND	Cumulative evidence from epidemiological , preclinical and clinical studies suggests estrogens may have psychoprotective effects in schizophrenic patients .
-BACKGROUND	Selective Estrogen Receptor Modulators could have therapeutic benefits in schizophrenia for both sexes without being hazardous to gynecological tissues or having feminizing effects .
-BACKGROUND	Few studies have been conducted regarding the effects of raloxifene on postmenopausal women suffering from schizophrenia .
-BACKGROUND	We conducted this placebo-controlled trial to compare the add-on effect of raloxifene to risperidone versus risperidone with placebo .
-METHODS	This was an 8-week , parallel-group , placebo-controlled trial undertaken at two universities affiliated psychiatric Hospitals in Iran .
-METHODS	Forty-six postmenopausal women with the definite diagnosis of schizophrenia were enrolled in the study .
-METHODS	Patients received risperidone ( 6 mg/day in 3 divided doses ) combined with either placebo ( N = 23 ) or 120 mg/day of raloxifene ( N = 23 ) for 8 weeks .
-METHODS	Patients were assessed by a psychiatrist at baseline and at 2 and 8 weeks after the start of medical therapy .
-METHODS	Efficacy was defined as the change from baseline to endpoint in score on Positive and Negative Syndrome Scale ( PANSS ) .
-RESULTS	For PANSS scores , the main effect comparing two types of intervention was not significant [ F ( 1 , 48 ) = 1.77 , p = 0.18 ] .
-RESULTS	For positive subscale scores , there was marginal significant interaction between intervention type and time [ F ( 2 , 47 ) = 2.93 , p = 0.06 ] and there was substantial main effect for time [ F ( 2 , 47 ) = 24.39 , p = 0.001 ] within both groups showing reduction in positive subscale scores across the three time periods .
-RESULTS	In addition , the main effect comparing two types of intervention was significant [ F ( 1 , 48 ) = 3.78 , p = 0.02 ] .
-RESULTS	On the other hand , for negative subscale scores , the main effect comparing two types of intervention was not significant [ F ( 1 , 48 ) = 1.43 , p = 0.23 ] .
-RESULTS	For general subscale scores , the main effect comparing two types of intervention was not significant [ F ( 1 , 48 ) = 0.03 , p = 0.86 ] .
-CONCLUSIONS	According to our findings , raloxifene as an adjunctive treatment to risperidone was only superior in improvement of positive symptoms and it was not effective in treating negative and general psychopathology symptoms .
-BACKGROUND	The trial was registered at the Iranian registry of clinical trials : IRCT201205131556N42 .
-
-###24737198
-OBJECTIVE	We investigated the long-term effects of repetitive transcranial magnetic stimulation ( rTMS ) delivered to the temporoparietal junction and compared contralateral and ipsilateral application in patients with unilateral tinnitus .
-METHODS	Prospective study .
-METHODS	A total of 61 patients with asymmetric hearing loss and nonpulsatile chronic tinnitus localized to the poorer ear who were refractory to medical treatment were enrolled .
-METHODS	Patients were randomly assigned to one of two treatment groups : 1-Hz stimulation applied to the temporoparietal junction either ipsilaterally ( n = 30 ) or contralaterally ( n = 31 ) to the symptomatic ear .
-METHODS	Changes in the Tinnitus Handicap Inventory ( THI ) scores and self-rating visual analog scores ( VAS ) for loudness , awareness , and annoyance were analyzed before and after treatment for 6 months .
-METHODS	Improved patients were defined as those with decreases in their THI scores by > 10 points and 20 % .
-RESULTS	There were no major complications or worsening of hearing .
-RESULTS	When analyzing the THI scores and VAS pre-rTMS and 6 months after rTMS , significant decreases were observed in patients overall ( P < .001 ) .
-RESULTS	For the comparison of long-term outcomes between the ipsilateral and contralateral stimulation groups , there were no differences in the degree of decrease in THI scores or VAS ( P > .05 ) .
-RESULTS	In addition , there was no significant difference in the rate of patients who improved between the ipsilateral ( 14 of 30 ) and contralateral ( 16 of 31 ) stimulation groups ( P = .800 ) .
-RESULTS	The ipsilateral group showed a more rapid improvement than the contralateral group .
-CONCLUSIONS	Daily application of 1-Hz rTMS to the temporoparietal area is safe and has long-term beneficial effects .
-CONCLUSIONS	The laterality of stimulation is not the decisive factor .
-
-###25145581
-BACKGROUND	A prospective endoscopic and radiologic evaluation of long-term outcomes of crushing and crushing with intrinsic stripping , 2 minimally destructive techniques used for the surgical treatment of concha bullosa .
-METHODS	Forty-two patients who underwent concha bullosa surgery ( a total of 55 conchae surgeries ) were included in the study .
-METHODS	The patients were allocated consecutively to either of the 2 groups : Group 1 ( crushing , n = 28 ) and Group 2 ( crushing with intrinsic stripping , n = 27 ) .
-METHODS	All procedures were performed endoscopically .
-METHODS	The presurgical and 1-year postsurgical endoscopic nasal cavity images and computed tomography ( CT ) scans of all patients were recorded .
-METHODS	Preoperative and postoperative measurements were compared using paired t test and Student t test .
-RESULTS	Gender and mean age of the 42 patients ( 55 conchae bullosa ) were as follows : 23 males , mean age 25.6 ( range , 18 to 41 ) years ; 18 females , mean age 24.2 ( range , 18 to 33 ) years .
-RESULTS	The patients were followed for 12.5 1.3 months .
-RESULTS	Comparisons of both the grading of endoscopic images and the concha bullosa volumes measured in CT images before and after treatment showed significant postsurgical reductions in both groups ; comparison between groups showed significant postsurgical decreases for Group 2 in both concha bullosa volumes and in endoscopic scoring ( p < 0.05 ) .
-CONCLUSIONS	Crushing with intrinsic stripping is an effective and easy technique ; when compared to crushing alone ; this technique provides a significantly more decrease in middle concha volumes as demonstrated both by the CT and by endoscopic evaluations .
-
-###25363099
-OBJECTIVE	The premenstrual syndrome ( PMS ) is a series of physical , mental , and behavioral symptoms with various severities , and disturbs social and personal relationships .
-OBJECTIVE	The syndrome appears during luteal phase of the menstrual cycle and is a common disorder of reproductive age .
-OBJECTIVE	Different treatments have been introduced for the syndrome due to its unknown complicated causes .
-OBJECTIVE	Vitamin B1 ( Thiamin ) may reduce symptoms of the syndrome through affecting the performance of coenzymes in the metabolism of carbohydrates and main branch of amino acid that plays an important role in appearance of physical and mental symptoms of the PMS .
-OBJECTIVE	Vitamin B1 is the first water-soluble discovered vitamin .
-OBJECTIVE	As it is effective in neural activity and muscle tonus in different body activities , including hematopoiesis , metabolism of carbohydrates , activities of the central nervous system and neuromuscular system , etc. , it can be effective in this dysmenorrhea that is a disorder resulting from uterine muscular contraction .
-OBJECTIVE	There are no enough studies and research on the effect of vitamin B1 on the symptoms of PMS , therefore , this study was conducted to determine the effect of vitamin B1 on the symptoms of PMS in students residing at dormitories of Jahrom University of Medical Sciences in 2013 .
-METHODS	In this double-blind placebo-controlled clinical trial , 80 students with PMS residing at dormitories of Jahrom University of Medical Sciences were divided randomly into two groups , vitamin B1 and placebo .
-METHODS	The severity of the symptoms of PMS in two cycles , before the intervention and during the intervention , was recorded by the students .
-METHODS	The data were collected using an information collection form , PMS provisional diagnosis form , daily status record form , Beck Depression Inventory .
-METHODS	The data were analyzed using descriptive and inferential statistics .
-RESULTS	There was no significant difference among the studied variables in terms of confounding variables .
-RESULTS	The comparison of vitamin B1 group before the intervention with that after the intervention showed that vitamin B1 reduced mean mental ( 35.08 % ) and physical ( 21.2 % ) symptoms significantly ( P < 0.0001 ) .
-RESULTS	Moreover , there was a significant difference between vitamin B1 and placebo groups in terms of mean mental and physical symptoms , as mean symptoms in vitamin B1 group was significantly lower than that in the placebo group ( P < 0.0001 ) .
-CONCLUSIONS	It seems that vitamin B1 is effective in recovery of mental and physical symptoms of PMS .
-CONCLUSIONS	Therefore , this vitamin can be used to reach a major goal of midwifery , that is , reduction of symptom severity of PMS , without any side effects .
-
-###24839984
-BACKGROUND	Chronic venous leg ulcers ( CVU ) are a common , unresolved medical problem .
-BACKGROUND	Silica gel fibre ( SGF ) is a novel biodegradable inorganic material developed to serve as a carrier substrate for the local release of pharmaceutical agents facilitating tissue repair .
-OBJECTIVE	To assess the performance and safety of SGF in subjects with CVU .
-METHODS	Open , randomized , standard-of-care-controlled , multi-centre trial .
-METHODS	Subjects ( ITT 120 patients ) received either SGF in addition to standard treatment or standard-of-care treatment ( S-o-C ) alone .
-METHODS	The primary performance variable was the time to healing of the target ulcer until the end of a 12 week treatment period .
-RESULTS	SGF was well tolerated .
-RESULTS	Mean time to healing up to week 12 was 85.62 days for the SGF group ( SE 1.5 ) and 79.66 days for the S-o-C group ( SE 1.77 ) ( p-value = 0.217 ) .
-RESULTS	There was no statistically relevant difference regarding the incidence of complete healing of the target ulcers by weeks 12 and 24 between the SGF and the S-o-C groups ( p-value > 0.05 ) .
-CONCLUSIONS	SGF is well tolerated and offers a promising perspective as a carrier substrate for the local release of active pharmaceutical agents into the wound site to promote tissue repair .
-
-###25045152
-METHODS	Genistein from foods or supplements is metabolized by the gut microbiota and the human body , thereby releasing many different metabolites into systemic circulation .
-METHODS	The order of their appearance in plasma and the possible influence of food format are still unknown .
-METHODS	This study compared the nutrikinetic profiles of genistein metabolites .
-RESULTS	In a randomized cross-over trial , 12 healthy young volunteers were administered a single dose of 30 mg genistein provided as a genistein tablet , a genistein tablet in low fat milk , and soy milk containing genistein glycosides .
-RESULTS	A high mass resolution LC-LTQ-Orbitrap FTMS platform detected and quantified in human plasma : free genistein , seven of its phase-II metabolites and 15 gut-derived metabolites .
-RESULTS	Interestingly , a novel metabolite , genistein-4 ' - glucuronide-7-sulfate ( G-4 ` G-7S ) was identified .
-RESULTS	Nutrikinetic analysis using population-based modeling revealed the order of appearance of five genistein phase II metabolites in plasma : ( 1 ) genistein-4 ' ,7 - diglucuronide , ( 2 ) genistein-7-sulfate , ( 3 ) genistein-4 ' - sulfate-7-glucuronide , ( 4 ) genistein-4 ' - glucuronide , and ( 5 ) genistein-7-glucuronide , independent of the food matrix .
-CONCLUSIONS	The conjugated genistein metabolites appear in a distinct order in human plasma .
-CONCLUSIONS	The specific early appearance of G-4 ' ,7 - diG suggests a multistep formation process for the mono and hetero genistein conjugates , involving one or two deglucuronidation steps .
-
-###24395492
-BACKGROUND	Charcot-Marie-Tooth ( CMT ) disease type 1A is the most common form of CMT .
-BACKGROUND	The main clinical features are distal weakness , sensory loss , and skeletal deformities .
-BACKGROUND	Although pain is a frequent complaint , small fiber involvement in CMT1A has not been studied extensively .
-METHODS	We assessed pain and small fiber involvement in 49 CMT1A patients using a variety of pain scales , pain questionnaires , and thermal thresholds .
-RESULTS	Forty-three of 49 patients ( 88 % ) complained of pain .
-RESULTS	The pain was localized to the feet in 61 % of patients .
-RESULTS	Only 18 % of patients had neuropathic pain .
-RESULTS	Cold and warm detection thresholds were elevated in 53 % and 12 % of patients , respectively .
-CONCLUSIONS	Our findings confirm that CMT1A patients have significant pain , which is more likely to be multifactorial in origin and suggests that a proportion of patients have small fiber dysfunction affecting mainly thinly myelinated A fibers .
-
-###24350936
-BACKGROUND	Metformin monotherapy is recommended as initial treatment of type 2 diabetes .
-BACKGROUND	The selection of optimal second-line therapy that is often necessary due to the progressive nature of the disease is still a subject of ongoing discussions .
-OBJECTIVE	The aim of the international EDGE ( Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin ) study was to prospectively compare the efficacy and safety of vildagliptin vs other oral antidiabetic agents in patients with type 2 diabetes not adequately controlled on monotherapy in a real-life clinical setting .
-OBJECTIVE	In this paper , we present the data of patients participating in the EDGE study in the Czech Republic .
-METHODS	Patients with type 2 diabetes not adequately controlled on monotherapy were enrolled into the study , and randomised into either the vildagliptin arm or control arm with another OAD at the discretion of the treating physician .
-METHODS	Patients with the addition of other incretin-based medications were not enrolled into the study .
-METHODS	The efficiency was evaluated as a proportion of patients reaching the combined endpoint of decreasing HbA1c > 3 mmol/mol without hypoglycaemia , peripheral oedema or treatment termination due to gastrointestinal side effects during the 12 months of treatment .
-RESULTS	654 patients were enrolled into the study in the Czech Republic .
-RESULTS	The mean age of the patients when enrolled into the study ( vildagliptin group vs control group ) was 59.5 10.6 vs 63.7 8.5 years , mean body mass index was 32.4 5.7 vs 31.7 6.5 kg/m2 , mean HbA1c was 62 12 vs 64 11 mmol/mol .
-RESULTS	The probability of reaching the combined primary endpoint ( calculated using a binary logistic regression model to calculate the odds ratios with 95 % confidence intervals ) was higher for vildagliptin regardless of baseline HbA1c or type of medication added in the control group .
-RESULTS	Primary endpoint was reached by 60.6 % of patients in the vildagliptin group vs 51.3 % of patients in the control group , odds ratio 1.46 ( 1.06 , 1.99 ) ; p < 0.019 .
-RESULTS	The proportion of patients reaching secondary endpoint ( HbA1c < 54 mmol/mol without hypoglycemic event or weight gain 3 % with baseline glycated hemoglobin > 54 mmol/mol was higher for vildagliptin 45.7 % vs 31.4 % in the control arm , odds ratio 1.84 ( 1.26 , 2.68 ) , p < 0.001 .
-RESULTS	The rate of adverse events was comparable in both groups .
-CONCLUSIONS	In a real-life clinical set-ting , the percentage of patients reaching the combined endpoint of decreasing HbA1c > 3 mmol/mol , without hypoglycaemia , peripheral oedema or treatment termination due to gastrointestinal side effects was higher after the addition of vildagliptin as compared to other antidiabetic agents with comparable rate of side effects .
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-###25426896
-OBJECTIVE	To evaluate the effect of ozonated oil on palatal wounds .
-METHODS	Eighteen patients were randomized and allocated to either the ozone group ( n = 8 ) or control ( n = 10 ) group .
-METHODS	Free gingival graft surgery was performed , and post-harvested palatal wounds were treated with either 2 mL ozonated oil or control oil daily for 1 week .
-METHODS	A planimetrical analysis analyzed the digital image for the wound sizes and shape factor at baseline , at 24 h , and days 5 , 7 , 14 , 21 , and 28 , postoperatively .
-METHODS	A cytological analysis used the keratinization and superficial cell indices at baseline , 24 h , and days 3 , 7 , 14 , and 21 and the second and third months , postoperatively .
-RESULTS	Planimetrical results showed a significant ( P 0.05 ) improvement in wound size on days 5 , 7 , 14 , 21 , and 28 , postoperatively , in the ozone group compared to the control group .
-RESULTS	Cytological results showed a significant ( P 0.001 ) improvement in epithelial healing on days 7 , 14 , and 21 , and the second and third months , postoperatively , after the application of ozonated oil compared to control oil .
-CONCLUSIONS	Our results showed significant improvement in wound size and epithelial healing after topical ozonated oil application compared to control oil on palatal wounds .
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-###25650633
-OBJECTIVE	The comparative incidences of hemidiaphragmatic paralysis associated with contemporary ultrasound-guided supraclavicular versus infraclavicular blockade have not received extensive study .
-OBJECTIVE	We tested the hypothesis that the infraclavicular approach results in a lower incidence of hemidiaphragmatic paralysis compared with supraclavicular blockade when a standard local anesthetic volume and concentration are used .
-METHODS	With institutional human ethics board approval , we enrolled 64 patients undergoing right-sided upper extremity surgery in a randomized , blinded , parallel-group trial .
-METHODS	Patients were assigned to ultrasound-guided supraclavicular or infraclavicular blockade with 30 mL of 0.5 % ropivacaine .
-METHODS	The primary end point was complete hemidiaphragmatic paralysis at 30 minutes , defined as a greater than 75 % reduction in diaphragmatic excursion measured with the voluntary sniff test using M-mode ultrasonography .
-METHODS	Partial paralysis was defined as a 25 % to 75 % reduction .
-RESULTS	Eleven ( 34 % ) of 32 patients in the supraclavicular group versus 1 ( 3 % ) of 32 in the infraclavicular group had complete hemidiaphragmatic paralysis ( P = 0.001 [ 1-tailed ] ; relative risk , 11.0 [ 95 % confidence interval , 1.5-80 .3 ] ) ; 44 % versus 13 % had any ( complete or partial ) paralysis ( P = 0.006 ; relative risk , 3.5 [ 95 % confidence interval , 1.3-9 .5 ] ) .
-RESULTS	Eight ( 25 % ) of 32 patients in the supraclavicular group versus 5 ( 16 % ) of 32 in the infraclavicular group reported dyspnea ( P = 0.54 ) .
-CONCLUSIONS	Ultrasound-guided supraclavicular blockade with 30 mL of 0.5 % ropivacaine produced complete hemidiaphragmatic paralysis in approximately one-third of patients .
-CONCLUSIONS	The infraclavicular approach greatly reduced this risk but did not eliminate it .
-CONCLUSIONS	These data may aid in the selection of the approach to brachial plexus blockade , particularly in ambulatory patients and/or those with respiratory comorbidities .
-
-###24284442
-BACKGROUND	Leucine is a key amino acid involved in the regulation of skeletal muscle protein synthesis .
-OBJECTIVE	We assessed the effect of the supplementation of a lower-protein mixed macronutrient beverage with varying doses of leucine or a mixture of branched chain amino acids ( BCAAs ) on myofibrillar protein synthesis ( MPS ) at rest and after exercise .
-METHODS	In a parallel group design , 40 men ( 21 1 y ) completed unilateral knee-extensor resistance exercise before the ingestion of 25 g whey protein ( W25 ) ( 3.0 g leucine ) , 6.25 g whey protein ( W6 ) ( 0.75 g leucine ) , 6.25 g whey protein supplemented with leucine to 3.0 g total leucine ( W6 + Low-Leu ) , 6.25 g whey protein supplemented with leucine to 5.0 g total leucine ( W6 + High-Leu ) , or 6.25 g whey protein supplemented with leucine , isoleucine , and valine to 5.0 g total leucine .
-METHODS	A primed continuous infusion of l - [ ring - ( 13 ) C6 ] phenylalanine with serial muscle biopsies was used to measure MPS under baseline fasted and postprandial conditions in both a rested ( response to feeding ) and exercised ( response to combined feeding and resistance exercise ) leg .
-RESULTS	The area under the blood leucine curve was greatest for the W6 + High-Leu group compared with the W6 and W6 + Low-Leu groups ( P < 0.001 ) .
-RESULTS	In the postprandial period , rates of MPS were increased above baseline over 0-1 .5 h in all treatments .
-RESULTS	Over 1.5-4 .5 h , MPS remained increased above baseline after all treatments but was greatest after W25 ( 267 % ) and W6 + High-Leu ( 220 % ) treatments ( P = 0.002 ) .
-CONCLUSIONS	A low-protein ( 6.25 g ) mixed macronutrient beverage can be as effective as a high-protein dose ( 25 g ) at stimulating increased MPS rates when supplemented with a high ( 5.0 g total leucine ) amount of leucine .
-CONCLUSIONS	These results have important implications for formulations of protein beverages designed to enhance muscle anabolism .
-CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT 1530646 .
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-###25869393
-OBJECTIVE	Prucalopride is effective at alleviating symptoms of chronic constipation in women .
-OBJECTIVE	The aim of this study was to assess the efficacy of 12 weeks of prucalopride treatment compared with placebo in men with chronic constipation .
-METHODS	This was a multicenter , stratified , randomized , parallel-group , double-blind , placebo-controlled , phase 3 study ( ClinicalTrials.gov identifier : NCT01147926 ) .
-METHODS	The primary end point was the proportion of patients with a mean of three or more spontaneous complete bowel movements ( SCBMs ) per week across the treatment period .
-METHODS	Efficacy end points were assessed using daily electronic diaries , global assessment of the severity of constipation and efficacy of treatment , and Patient Assessment of Constipation-Symptoms ( PAC-SYM ) and Patient Assessment of Constipation-Quality of Life ( PAC-QOL ) questionnaires .
-RESULTS	In total , 374 patients were enrolled in the study .
-RESULTS	Significantly more patients achieved a mean of three or more SCBMs per week in the prucalopride group ( 37.9 % ) than in the placebo group ( 17.7 % , P < 0.0001 ) .
-RESULTS	The proportion of patients rating their constipation treatment as `` quite a bit '' to `` extremely '' effective at the final on-treatment visit was 46.7 and 30.4 % in the prucalopride and placebo groups , respectively .
-RESULTS	The difference between treatment groups was statistically significant ( P < 0.0001 ) .
-RESULTS	The proportion of patients with an improvement of at least 1 point in PAC-QOL satisfaction subscale score was 52.7 and 38.8 % in the prucalopride and placebo groups , respectively ( P = 0.0035 ) .
-RESULTS	Prucalopride had a good safety profile and was well tolerated .
-CONCLUSIONS	Prucalopride is effective , has a good safety profile , and is well tolerated for the treatment of men with chronic constipation .
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-###26095435
-BACKGROUND	People with prediabetes are at increased risk for developing type 2 diabetes mellitus .
-BACKGROUND	Weight reduction through lifestyle modification can significantly reduce diabetes risk .
-BACKGROUND	Yet , weight loss varies among individuals and some people do not achieve clinically meaningful weight loss after treatment .
-OBJECTIVE	Our aim was to evaluate the time point and threshold for achieving 5 % weight loss after completion of a 16-week worksite , lifestyle intervention for diabetes prevention .
-METHODS	Weight change before and after the behavioral intervention among participants randomized to the experimental group was examined .
-METHODS	Individuals with prediabetes aged 18 to 65 years with a body mass index ( calculated as kg/m ( 2 ) ) of 25 to 50 at Ohio State University were eligible .
-METHODS	The 16-week , group-based intervention , adapted from the Diabetes Prevention Program , was delivered to 32 participants in the experimental group .
-METHODS	Percent weight loss was assessed weekly during the intervention and at 4 - and 7-month follow-up .
-METHODS	Linear regression modeled the relationship between percent weight loss during month 1 of the intervention and percent weight loss at 4 and 7 months .
-METHODS	Logistic regression modeled failure to lose 5 % weight loss at 4 and 7 months using weekly weight change during the first month of intervention .
-RESULTS	Percent weight loss at intervention week 5 was significantly associated with percent weight loss at 4 and 7 months ( all P < 0.001 ) .
-RESULTS	Only 11.1 % and 12.5 % of participants who failed to achieve a 2.5 % weight-loss threshold during month 1 achieved 5 % weight loss at months 4 and 7 , respectively .
-CONCLUSIONS	The first month of lifestyle treatment is a critical period for helping participants achieve weight loss .
-CONCLUSIONS	Otherwise , individuals who fail to achieve at least 2.5 % weight loss may benefit from more intensive rescue efforts or stepped-care interventions .
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-###25011946
-OBJECTIVE	Mealtime insulin is commonly added to manage hyperglycemia in type 2 diabetes when basal insulin is insufficient .
-OBJECTIVE	However , this complex regimen is associated with weight gain and hypoglycemia .
-OBJECTIVE	This study compared the efficacy and safety of exenatide twice daily or mealtime insulin lispro in patients inadequately controlled by insulin glargine and metformin despite up-titration .
-METHODS	In this 30-week , open-label , multicenter , randomized , noninferiority trial with 12 weeks prior insulin optimization , 627 patients with insufficient postoptimization glycated hemoglobin A1c ( HbA1c ) were randomized to exenatide ( 10-20 g/day ) or thrice-daily mealtime lispro titrated to premeal glucose of 5.6-6 .0 mmol/L , both added to insulin glargine ( mean 61 units/day at randomization ) and metformin ( mean 2,000 mg/day ) .
-RESULTS	Randomization HbA1c and fasting glucose ( FG ) were 8.3 % ( 67 mmol/mol ) and 7.1 mmol/L for exenatide and 8.2 % ( 66 mmol/mol ) and 7.1 mmol/L for lispro .
-RESULTS	At 30 weeks postrandomization , mean HbA1c changes were noninferior for exenatide compared with lispro ( -1.13 and -1.10 % , respectively ) ; treatment differences were -0.04 ( 95 % CI -0.18 , 0.11 ) in per-protocol ( n = 510 ) and -0.03 ( 95 % CI -0.16 , 0.11 ) in intent-to-treat ( n = 627 ) populations .
-RESULTS	FG was lower with exenatide than lispro ( 6.5 vs. 7.2 mmol/L ; P = 0.002 ) .
-RESULTS	Weight decreased with exenatide and increased with lispro ( -2.5 vs. +2.1 kg ; P < 0.001 ) .
-RESULTS	More patients reported treatment satisfaction and better quality of life with exenatide than lispro , although a larger proportion of patients with exenatide experienced treatment-emergent adverse events .
-RESULTS	Exenatide resulted in fewer nonnocturnal hypoglycemic episodes but more gastrointestinal adverse events than lispro .
-CONCLUSIONS	Adding exenatide to titrated glargine with metformin resulted in similar glycemic control as adding lispro and was well tolerated .
-CONCLUSIONS	These findings support exenatide as a noninsulin addition for patients failing basal insulin .
-
-###25078901
-OBJECTIVE	We evaluated the effect of the MD-Logic system on overnight glycemic control at patients ' homes .
-METHODS	Twenty-four patients ( aged 12-43 years ; average A1c 7.5 0.8 % , 58.1 8.4 mmol/mol ) were randomly assigned to participate in two overnight crossover periods , each including 6 weeks of consecutive nights : one under closed loop and the second under sensor-augmented pump ( SAP ) therapy at patients ' homes in real-life conditions .
-METHODS	The primary end point was time spent with sensor glucose levels below 70 mg/dL ( 3.9 mmol/L ) overnight .
-RESULTS	Closed-loop nights significantly reduced time spent in hypoglycemia ( P = 0.02 ) and increased the percentage of time spent in the target range of 70-140 mg/dL ( P = 0.003 ) compared with nights when the SAP therapy was used .
-RESULTS	The time spent in substantial hyperglycemia above 240 mg/dL was reduced by a median of 52.2 % ( interquartile range [ IQR ] 4.8 , 72.9 % ; P = 0.001 ) under closed-loop control compared with SAP therapy .
-RESULTS	Overnight total insulin doses were lower in the closed-loop nights compared with the SAP nights ( P = 0.04 ) .
-RESULTS	The average daytime glucose levels after closed-loop operation were reduced by a median of 10.0 mg/dL ( IQR -2.7 , 19.2 ; P = 0.017 ) while lower total insulin doses were used ( P = 0.038 ) .
-RESULTS	No severe adverse events occurred during closed-loop control ; there was a single event of severe hypoglycemia during a control night .
-CONCLUSIONS	The long-term home use of automated overnight insulin delivery by the MD-Logic system was found to be a feasible , safe , and an effective tool to reduce nocturnal hypoglycemia and improve overnight glycemic control in subjects with type 1 diabetes .
-
-###25405577
-OBJECTIVE	This study aimed to describe pretreatment patient characteristics and baseline quality-of-life scores as they relate to the development of grade 3 or 4 toxicity in patients receiving chemotherapy for advanced/recurrent cervical cancer .
-METHODS	The study sample was drawn from Gynecologic Oncology Group protocols 179 and 204 .
-METHODS	Grade 3 or 4 toxicities were considered in 4 specified categories as follows : peripheral neuropathy , fatigue , hematological , and gastrointestinal ( GI ) .
-METHODS	The data variables explored included age , stage , pretreatment radiation , performance status ( PS ) at treatment initiation , and baseline Functional Assessment of Cancer Therapy-Cervix ( FACT-Cx ) score .
-METHODS	A logistic regression model was developed with various adverse events as binary ( 0/1 ) outcomes .
-RESULTS	Six hundred seventy-three patient-reported questionnaires were used in the analyses .
-RESULTS	At baseline , pain was the most severe patient-reported symptom .
-RESULTS	Baseline line-item patient concerns did demonstrate specific correlations with the development of individual toxicities .
-RESULTS	In 401 patients who were enrolled on Gynecologic Oncology Group 204 ( fatigue not measured on 179 ) , a worse PS predicted the development of grade 3 or 4 fatigue ( odds ratio , 2.78 ; 95 % confidence interval , 1.66-4 .68 ) .
-RESULTS	Exposure to previous radiation , treatment regimen , and a worse FACT-Cx score were associated with the reporting of both grade 3 or 4 leukopenia ( P < 0.05 ) and anemia ( P < 0.0005 ) .
-RESULTS	Performance status and treatment regimen ( P < 0.05 ) were associated with the development of grade 3 or 4 thrombocytopenia .
-RESULTS	Age and treatment regimen ( P < 0.05 ) were associated with the development of grade 3 or 4 neutropenia .
-RESULTS	The FACT-Cx score ( P = 0.0016 ) predicted grade 3 or 4 GI toxicity .
-CONCLUSIONS	The development of fatigue , hematological , and GI toxicity might be predictable based on factors other than treatment assignment such as age , PS , and patient-reported quality-of-life measurement .
-
-###24708645
-BACKGROUND	The ongoing scale-up of antiretroviral therapy ( ART ) in sub-Saharan Africa has prompted the interest in surveillance of transmitted and acquired HIV drug resistance .
-BACKGROUND	Resistance data on virological failure and mutations in HIV infected populations initiating treatment in sub-Saharan Africa is sparse .
-METHODS	HIV viral load ( VL ) and resistance mutations pre-ART and after 6 months were determined in a prospective cohort study of ART-nave HIV patients initiating first-line therapy in Jimma , Ethiopia .
-METHODS	VL measurements were done at baseline and after 3 and 6 months .
-METHODS	Genotypic HIV drug resistance ( HIVDR ) was performed on patients exhibiting virological failure ( > 1000 copies/mL at 6 months ) or slow virological response ( > 5000 copies/mL at 3 months and < 1000 copies/mL at 6 months ) .
-RESULTS	Two hundred sixty five patients had VL data available at baseline and at 6 months .
-RESULTS	Virological failure was observed among 14 ( 5.3 % ) participants out of 265 patients .
-RESULTS	Twelve samples were genotyped and six had HIV drug resistance ( HIVDR ) mutations at baseline .
-RESULTS	Among virological failures , 9/11 ( 81.8 % ) harbored one or more HIVDR mutations at 6 months .
-RESULTS	The most frequent mutations were K103N and M184VI .
-CONCLUSIONS	Our data confirm that the currently recommended first-line ART regimen is efficient in the vast majority of individuals initiating therapy in Jimma , Ethiopia eight years after the introduction of ART .
-CONCLUSIONS	However , the documented occurrence of transmitted resistance and accumulation of acquired HIVDR mutations among failing patients justify increased vigilance by improving the availability and systematic use of VL testing to monitor ART response , and underlines the need for rapid , inexpensive tests to identify the most common drug resistance mutations .
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-###24419019
-BACKGROUND	Mirror therapy ( MT ) and electromyography-triggered neuromuscular stimulation ( ETMS ) are both effective treatments for impaired upper limbs following stroke .
-BACKGROUND	A combination of these two treatments ( ETMS-MT ) may result in greater gain than either treatment alone .
-OBJECTIVE	The feasibility and possible effects of ETMS-MT upon upper extremity function were investigated in stroke patients .
-METHODS	Thirteen post-acute stroke patients were randomly assigned to an immediate ETMS-MT group or a delayed ETMS-MT group and then underwent an 8-week training program .
-METHODS	The immediate ETMS-MT group received ETMS-MT in addition to physical and occupational therapy ( PT+OT ) for 4 weeks .
-METHODS	They then received only PT+OT for the next 4 weeks .
-METHODS	In the delayed ETMS-MT group , interventions were provided in the reverse order .
-METHODS	The main outcome measure was the Fugl-Meyer Assessment ( FMA ) .
-RESULTS	The immediate ETMS-MT group showed significantly greater gain in FMA in the first 4 weeks .
-RESULTS	The delayed ETMS-MT group showed significantly greater gain in active range of motion during the latter 4 weeks .
-RESULTS	No adverse effects were reported following ETMS-MT .
-CONCLUSIONS	ETMS-MT might be as effective as independent MT or ETMS without causing any side effects .
-CONCLUSIONS	Future research should focus upon the direct comparisons between independent and combined interventions .
-
-###24329481
-BACKGROUND	Gold-standard assessment of acute wound healing has traditionally been through histological analysis of biopsied tissue .
-BACKGROUND	However , this process is invasive with recognized side-effects .
-BACKGROUND	Optical coherence tomography ( OCT ) is a noninvasive technique generating high-resolution real-time images of cutaneous architecture .
-OBJECTIVE	To compare OCT with histological assessment of in vivo acute wound healing and ascertain the level of agreement between modalities for measurement of defined cutaneous structures .
-METHODS	Punch biopsies ( 5mm ) were harvested from 50 healthy volunteers .
-METHODS	Wounds healed by secondary intention until they were re-excised 7 , 14 , 21 or 28days later depending on random group allocation .
-METHODS	Wounds were assessed weekly for 6weeks using OCT and compared with histological findings derived from time-matched biopsies .
-METHODS	Dimensions of four cutaneous structures were measured using both modalities and the level of agreement was established by Bland-Altman analysis .
-METHODS	The mean greyscale value ( MGV ) of the upper reticular dermis was derived from OCT images at all time points .
-RESULTS	Both techniques showed anatomical congruity in normal and wounded skin with correlating architectural changes associated with inflammatory , proliferative and remodelling wound healing phases .
-RESULTS	MGV was significantly increased 6weeks after wounding ( P = 0001 ) and may represent a novel measure of wound fibrosis .
-RESULTS	Despite good association of histomorphometric values with low but consistent bias ( range -4181 to 0431m ) , Bland-Altman plots demonstrated poor agreement between OCT and histology .
-CONCLUSIONS	Optical coherence tomography enabled accurate assessment of healing tissue comparable with histological analysis of biopsy specimens .
-CONCLUSIONS	This noninvasive tool is highly suited to wound assessment and may represent a diagnostic alternative to punch biopsies .
-
-###25197812
-OBJECTIVE	Obstructive sleep apnea ( OSA ) is commoner in patients with fluid-retaining states than in those without fluid retention , in men than in women , and worsens with aging .
-OBJECTIVE	In men , OSA severity is related to the amount of fluid shifting out of the legs overnight , but a cause-effect relationship is not established .
-OBJECTIVE	Our objective was to test the hypothesis that mimicking fluid overload during sleep would increase severity of OSA more in older ( 40 years ) than in younger men ( < 40 years ) .
-METHODS	Randomized , single-blind , double crossover study .
-METHODS	Research sleep laboratory .
-METHODS	Seven older and 10 younger men with non-severe or no sleep apnea , matched for body mass index .
-METHODS	During the control arm , normal saline was infused to keep the vein open .
-METHODS	During intervention , subjects received an intravenous bolus of normal saline ( 22 mL/kg body weight ) after sleep onset while they were wearing compression stockings to prevent fluid accumulation in the legs .
-RESULTS	Compared to younger men , infusion of similar amounts of saline in older men caused a greater increase in neck circumference ( P < 0.05 ) and in the AHI ( 32.2 22.1 vs. 2.2 7.1 , P = 0.002 ) .
-CONCLUSIONS	Older men are more susceptible to the adverse effects of intravenous fluid loading on obstructive sleep apnea severity than younger men .
-CONCLUSIONS	This may be due to age-related differences in the amount of fluid accumulating in the neck or upper airway collapsibility in response to intravenous fluid loading .
-CONCLUSIONS	These possibilities remain to be tested in future studies .
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-###24662128
-OBJECTIVE	Biopsy confirmed that cervical intraepithelial neoplasia ( CIN ) may naturally regress or progress .
-OBJECTIVE	Currently , the risk assessment for CIN progression to cervical cancer is still not satisfactory in clinical practice .
-OBJECTIVE	We investigated copy number and protein expression of TP63 and MYC and explored the possibility to use them as progression biomarkers .
-METHODS	Copy numbers of TP63 and MYC , as well as human papilloma virus ( HPV ) integration status , were determined by fluorescence in situ hybridization in 39 patients with CIN and 66 patients with cervical cancer .
-METHODS	Corresponding protein expressions were analyzed by immunohistochemistry .
-METHODS	Receiver operating characteristic curves were used to measure the diagnostic test performance for the detection of cervical cancer from CIN .
-METHODS	Sensitivity and specificity values of biomarkers were calculated .
-RESULTS	The average copy number and expression of TP63 and MYC , as well as the HPV integration rate , increased in the progression of CIN to cervical cancer .
-RESULTS	Receiver operating characteristic analysis for detection of cervical cancer resulted in area under the curve ( AUC ) values of TP63 copy number ( AUC , 0.96 ; 95 % confidence interval [ CI ] , 0.91-1 .00 ) , MYC copy number ( AUC , 0.92 ; 95 % CI , 0.85-0 .96 ) , TP63 expression ( AUC , 0.73 ; 95 % CI , 0.61-0 .85 ) , and HPV-16 integration ( AUC , 0.73 ; 95 % CI , 0.60-0 .85 ) .
-RESULTS	MYC expression was not able to statistically distinguish cancer from CIN ( P = 0.393 ) .
-RESULTS	The combinations increased the specificity slightly but not sensitivity .
-RESULTS	Among them , TP63 amplification showed the best diagnostic performance .
-CONCLUSIONS	Amplification and overexpression of TP63 and MYC , and HPV integration rate , are associated with the transition of CIN to cervical cancer .
-CONCLUSIONS	Future studies on these biomarkers will help to assess the risk of CIN progression .
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-###25262259
-BACKGROUND	Discontinuations and/or interruptions in aspirin therapy for secondary cardioprotection due to upper gastrointestinal ( UGI ) complications or symptoms have been shown to increase the risk for subsequent cardiovascular events .
-BACKGROUND	PA32540 is a coordinated-delivery , combination tablet consisting of enteric-coated aspirin ( EC-ASA ) 325 mg and immediate-release ( IR ) omeprazole 40 mg .
-METHODS	Two identically-designed , 6-month , randomized , double-blind trials evaluated PA32540 vs. EC-ASA 325 mg in a secondary cardiovascular disease prevention population taking aspirin 325 mg daily for 3 months and at risk for ASA-associated gastric ulcers ( GUs ) .
-METHODS	The combined study population was 1049 subjects ( 524 randomized to PA32540 , 525 to EC-ASA 325 mg ) .
-METHODS	The primary endpoint was the occurrence of endoscopically-determined gastric ulceration over 6 months .
-METHODS	Safety outcomes included the rates of major adverse cardiovascular events ( MACE ) and UGI symptoms .
-RESULTS	Significantly fewer PA32540-treated subjects ( 3.2 % ) developed endoscopic GUs vs. EC-ASA 325 mg-treated subjects ( 8.6 % ) ( P < .001 ) .
-RESULTS	Overall occurrence of MACE was low ( 2.1 % ) , with no significant differences between treatments in types or incidence of MACE .
-RESULTS	PA32540-treated subjects had significantly fewer UGI symptoms ( P < .001 ) and significantly fewer discontinuations due to pre-specified UGI adverse events ( 1.5 % vs. 8.2 % , respectively ; P < .001 ) .
-CONCLUSIONS	PA32540 reduced the incidence of endoscopic GUs compared to EC-ASA 325 mg , but with a similar cardiovascular event profile .
-CONCLUSIONS	Due to fewer UGI symptoms , continuation on aspirin therapy was greater in the PA32540 treatment arm .
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-###24410783
-BACKGROUND	Anaphylaxis is a life-threatening emergency .
-BACKGROUND	If promptly administered , adrenaline is potentially life-saving .
-BACKGROUND	Many food-allergic-children/carers are unsure when to use their adrenaline autoinjectors , contributing to a low quality of life and worse outcomes in the setting of an acute allergic reaction .
-OBJECTIVE	The aim of this study was to assess the effectiveness of 24-hour telephone access to specialist clinical advice on disease-specific quality of life .
-METHODS	A pragmatic two-arm , parallel-group randomized control trial was conducted .
-METHODS	Children/carers ( < 16years ) with food allergy , trained in adrenaline auto-injector use , were recruited from a hospital-based paediatric allergy clinic .
-METHODS	Baseline disease-specific quality of life was ascertained using the validated Food-Allergy-Related Quality-of-Life Questionnaire ( FAQLQ ) , either Parent Form , Child Form or Teenager Form depending on child 's age .
-METHODS	Participants were then centrally randomized for a 6-month period to 24-hour telephone specialist support line or to usual care .
-METHODS	The primary outcome measure was a change in FAQL scores , at one and 6months postrandomization , compared with baseline .
-METHODS	The minimum clinically important difference ( MCID ) in score is 0.5 .
-RESULTS	Fifty two children/carers were recruited .
-RESULTS	FAQL scores remained static in the control group across the three time points .
-RESULTS	Scores gradually improved in the intervention group , with a significant difference seen at 6months ( T1-T3 Mean difference = -1.5 , ( CI 0.87-2 .25 ) P < 0.005 ] Follow-up questionnaires , 6months after the intervention was removed , T4 , showed sustained significant difference between the groups ( control M = 3.0 ; intervention M = 1.1 [ t = -4.113 , P < 0.05 ] ) .
-CONCLUSIONS	The 24-hour helpline improved food-allergy-specific quality of life in children .
-CONCLUSIONS	Six-month intervention support resulted in sustained benefits for at least a further 6months .
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-###25146509
-OBJECTIVE	To evaluate the effects of prone position ventilation combined with recruitment maneuvers ( RM ) on clinical outcomes in patients with severe acute respiratory distress syndrome ( ARDS ) .
-METHODS	In this prospective , randomized , controlled trial , we randomly assigned 116 sequential patients with severe ARDS to the intervention group ( which undergo prone-positioning with RM sessions of at least 10 hours ) or to the control group ( which be left in the supine position ) .
-RESULTS	From July 2012 to July 2013 , 116 severe ARDS patients sequentially admitted to the critical department of Peking Union Medical College Hospital were enrolled in the study with 60 patients assigned to the control group and 56 patients to the intervention group .
-RESULTS	No significant difference was found between the two groups in the demographics including the median patient age , sex ratio , initial Acute Physiology and Chronic Health Evaluation II scores , initial pulmonary function and the sources of ARDS .
-RESULTS	The oxygenation index recorded in the supine position was significantly higher in the intervention group than in the control group since day 3 , whereas the positive end-expiratory pressure and fraction of inspired O2 were significantly lower in the intervention group .
-RESULTS	The plateau pressure and static compliance of the respiratory system were similar in the two groups .
-RESULTS	The intervention group had shorter length of ICU stay , fewer ventilation days and decreased 28-day mortality than the control group .
-RESULTS	The tracheotomy ratio and the time to successful extubation were similar in the two groups .
-RESULTS	No significant difference between the two groups was shown in the incidence of complications , except for the grade 1 pressure sore , which was higher in the intervention group .
-CONCLUSIONS	In patients with severe ARDS , application of prolonged prone-positioning with RM sessions significantly improves the clinical outcomes .
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-###24548289
-BACKGROUND	Diets rich in fermentable residues increase intestinal gas production .
-BACKGROUND	Our aim was to demonstrate the potential effects of diet on gas-related symptoms .
-METHODS	The effect of a low-flatulogenic test diet ( restricted to foodstuffs low in fermentable residues ; n = 15 ) was compared to that of a balanced control diet ( Mediterranean type ; n = 15 ) in 30 patients complaining of flatulence and other abdominal symptoms using a randomized parallel design .
-METHODS	The following outcomes were measured daily : number of anal gas evacuations by an event marker , severity of gas-related symptoms by 0-10 scales , and sensation of digestive comfort by a -5 ( unpleasant ) to +5 ( pleasant ) scale .
-METHODS	Measurements were taken pretreatment for 3days on their habitual diet and for 7days during the treatment phase .
-RESULTS	No pretreatment differences were detected between patients allocated to the control or test diets .
-RESULTS	The test diet significantly reduced the number of gas evacuations ( by 5410 % ; p = 0.002 vs basal diet ) whereas the control diet had a lesser effect ( reduction by 289 % ; p = 0.059 vs basal diet ; p = 0.089 vs test diet ) .
-RESULTS	Compared to the control diet , the test diet significantly reduced flatulence ( by 487 % vs 278 % , respectively ; p = 0.018 ) , abdominal distension ( by 484 % vs 2212 % , respectively ; p = 0.038 ) , and enhanced digestive well-being ( by 14918 % vs 5822 % , respectively ; p = 0.006 ) .
-CONCLUSIONS	In patients with gas-related symptoms , a low-flatulogenic diet produces immediate beneficial effects with digestive , cognitive , and emotive dimensions .
-CONCLUSIONS	The number of gas evacuations is an objective biological marker of response to dietary treatment .
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-###25457355
-OBJECTIVE	To examine the efficacy of an integrative yoga programme as adjuvant treatment of essential arterial hypertension .
-METHODS	An Integrative yoga programme was conducted during three months in 26 sessions with a group of ten essential arterial hypertension patients at a public health centre .
-METHODS	The same number of patients acted as the control group without treatment .
-METHODS	The patients were randomly selected and assigned to the groups .
-METHODS	All patients filled in the Positive and Negative Affect Schedule ( PANAS ) , the Hospital Anxiety and Depression Scale ( HADS ) and the Smith Relaxation States Inventory 3 ( SRSI3 ) before and after the treatment .
-RESULTS	A statistically significant reduction of systolic and diastolic blood pressure , negative affect , symptoms of anxiety and degree of stress could be observed in the study group .
-CONCLUSIONS	These positive and promising results confirm the effectiveness of these techniques in the treatment of essential arterial hypertension and suggest possible further investigations .
-
-###25795645
-OBJECTIVE	To test if TIA/stroke electronic decision support in primary care improves management .
-METHODS	Multicenter , single-blind , parallel-group , cluster randomized , controlled trial comparing TIA/stroke electronic decision support guided management with usual care .
-METHODS	Main outcomes were guideline adherence and 90-day stroke risk .
-METHODS	Secondary outcomes were cerebrovascular/vascular/death / adverse events , cost , and user feedback .
-METHODS	Main analysis was logistic regression with a normal random effect for clusters using a generalized linear mixed model .
-RESULTS	Twenty-nine clinics were randomized to intervention , 27 to control , recruiting 172 and 119 eligible patients .
-RESULTS	More intervention patients received guideline-adherent care ( 131/172 ; 76.2 % ) than control patients ( 49/119 ; 41.2 % ) ( adjusted odds ratio [ OR ] 4.57 ; 95 % confidence interval [ CI ] 2.39-8 .71 ; p < 0.001 ) .
-RESULTS	Ninety-day stroke occurred in 2/172 ( 1.2 % ) intervention and 5/119 ( 4.2 % ) control patients ( OR 0.27 ; 95 % CI 0.05-1 .41 ; p = 0.098 ) .
-RESULTS	Ninety-day TIA or stroke occurrence was lower in the intervention group , 4/172 ( 2.3 % ) compared to 10/119 ( 8.5 % ) control ( adjusted OR 0.26 ; 95 % CI 0.70-0 .97 ; p = 0.045 ) .
-RESULTS	Fewer vascular events/deaths occurred in intervention , 6/172 ( 3.5 % ) , than in control patients , 14/119 ( 11.9 % ) ( adjusted OR 0.27 ; 95 % CI 0.09-0 .78 ; p = 0.016 ) .
-RESULTS	Treatment cost ratio of 0.65 ( 95 % CI 0.47-0 .91 ; p = 0.013 ) favored the intervention without increased adverse events .
-RESULTS	Clinician feedback was positive .
-CONCLUSIONS	Primary care use of the TIA/stroke electronic decision support tool improves guideline adherence , safely reduces treatment cost , achieves positive user feedback , and may reduce cerebrovascular and vascular event risk following TIA/stroke .
-METHODS	This study provides Class II evidence that a primary care electronic decision support tool improves guideline adherence and might reduce 90-day stroke risk .
-
-###25190522
-BACKGROUND	Nicotine is a known analgesic .
-BACKGROUND	Our primary aim was to test the hypothesis that intranasal nicotine administered intraoperatively reduces the need for postoperative opioids .
-BACKGROUND	The secondary outcomes included evaluation of both postoperative pain and nausea and vomiting ( PONV ) .
-METHODS	Nonsmoking female patients undergoing laparoscopic bariatric operations were randomized to receive either 3 mg intranasal nicotine ( N = 42 ) or placebo spray ( N = 47 ) at the conclusion of surgery .
-METHODS	Postoperative opioid use converted to intravenous morphine equivalents ( iv MEQ ) and PONV rates were recorded during both the recovery room postanesthesia care unit ( PACU ) stay and the first 24 postoperative hours .
-METHODS	All patients received multimodal antiemetic prophylaxis .
-RESULTS	Total iv MEQ were not significantly reduced during the PACU stay in patients receiving nicotine ( median [ interquartile range ( IQR ) ] , 5.3 [ 0 , 10.0 ] mg for nicotine vs. 5.2 [ 0 , 12.7 ] mg for placebo , one-tailed P = 0.414 ) or for the first 24 h following PACU discharge ( 39.6 [ 20.0 , 52.5 ] mg for nicotine vs. 32.7 [ 20.3 , 51.3 ] mg for placebo , one-tailed P = 0.752 ) .
-RESULTS	For the combined period ( PACU + 24-h post-PACU discharge ) , iv MEQ were 45.8 [ 27.0 , 58.6 ] mg for nicotine and 39.4 [ 23.5 , 60.0 ] mg for placebo , one-tailed P = 0.801 .
-RESULTS	Compared to placebo , a higher percentage of patients administered nicotine received antiemetics in the PACU ( 57.1 vs. 25.5 % , P = 0.002 ) .
-CONCLUSIONS	Intraoperative intranasal nicotine did not exhibit opioid-sparing effect in nonsmoking bariatric female patients .
-CONCLUSIONS	Despite antiemetic prophylaxis , the use of nicotine was associated with the higher frequency of the use of rescue antiemetics in PACU .
-
-###25335329
-OBJECTIVE	To study the effect of Shugan Jiangu Recipe ( SJR ) on bone mineral density ( BMD ) and serum bone metabolic biochemical markers in postmenopausal breast cancer patients with osteopenia .
-METHODS	Totally 38 patients of postmenopausal women with breast cancer , who received aromatase inhibitors ( AIs ) , were assigned to the treatment group ( 21 cases ) and the control group ( 17 cases ) by using random digit table .
-METHODS	All patients took Caltrate D Tablet ( containing Ca 600 mg and Vit D3 125 IU ) , one tablet daily .
-METHODS	Patients in the treatment group took SJR , 6 g each time , twice daily for 6 successive months .
-METHODS	The bone mineral density ( BMD ) level was detected before treatment and at months 6 after treatment .
-METHODS	Levels of bone alkaline phosphatase ( BALP ) , bone gla protein ( BGP ) , tartrate-resistant acid phosphatase ( TRAP ) , and C-terminal telopeptide of type II collagen ( CTX-II ) were detected by enzyme linked immunosorbent assay ( ELISA ) .
-METHODS	The drug safety was also assessed .
-RESULTS	Compared with before treatment , BMD of L2-4 and femur neck obviously increased in the treatment group at month 6 after treatment ( P < 0.01 ) , serum BALP and TRAP decreased ( P < 0.05 ) .
-RESULTS	Compared with before treatment , BMD of L2-4 and femur neck obviously decreased in the control group at month 6 after treatment ( P < 0.05 ) , serum BALP and TRAP increased ( P < 0.01 ) .
-RESULTS	Compared with the control group , lumbar and femur neck BMD obviously increased , serum levels of BGP and BALP obviously decreased , and serum levels of CTX-II and TRAP obviously increased in the treatment group at month 6 after treatment ( P < 0.01 ) .
-RESULTS	No serious adverse event occurred during the treatment period .
-RESULTS	Bone fracture occurred in one case of the control group ( 5.8 % ) .
-CONCLUSIONS	SJR could attenuate bone loss of postmenopausal women with breast cancer who received AIs , increase BMD and improve abnormal bone metabolism .
-
-###25488331
-BACKGROUND	School-based influenza immunization can effectively address accessibility barriers , but injected inactivated influenza vaccines ( IIV ) may not be acceptable to some children and parents in school settings .
-OBJECTIVE	To better understand the feasibility of offering intranasal live attenuated influenza vaccines ( LAIV ) through schools , we assessed uptake , stakeholder acceptability , and cost of school-based delivery of LAIV compared to IIV .
-METHODS	We piloted an open-label cluster randomized trial involving 10 elementary schools in Peterborough , Ontario during the 2013-2014 influenza vaccination campaign .
-METHODS	Schools were randomized to having students receive IIV or LAIV at publicly-funded school-based clinics organized by the local public health department .
-METHODS	We measured the percentage of students vaccinated with at least one dose of influenza vaccine at school .
-METHODS	Stakeholder acceptability was evaluated through a questionnaire of parents and interviews of public health department personnel and school principals .
-METHODS	We compared the costs per dose of vaccine administered , including staff time and costs of vaccines and supplies .
-RESULTS	Single-dose influenza vaccine uptake was higher for the five schools offering LAIV than for the five offering IIV ( 19.3 % vs. 12.2 % , p = 0.02 ) .
-RESULTS	Interviews with nine school principals and five public health department personnel suggested that the clinics ran smoothly with little disruption to school routines , and that LAIV was associated with increased efficiency and calmer children .
-RESULTS	All interviewees cited unfamiliarity with LAIV and the study recruitment package length as potential reasons for low uptake .
-RESULTS	The cost per vaccine dose administered was $ 38.67 for IIV and $ 43.50 for LAIV .
-CONCLUSIONS	Use of LAIV in school-based clinics was associated with increased vaccine uptake and the perception among immunizing staff of reduced child anxiety , but also slightly higher vaccine administration costs , compared to IIV .
-CONCLUSIONS	However , uptake was low for both groups .
-CONCLUSIONS	More effective strategies to promote influenza vaccines and to obtain parent consent may improve vaccine uptake .
-BACKGROUND	ClinicalTrials.gov NCT01995851 .
-BACKGROUND	Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network .
-
-###25452229
-OBJECTIVE	To assess the long-term effects of an intensive lifestyle intervention on physical function using a randomized post-test design in the Look AHEAD trial .
-METHODS	Overweight and obese ( BMI 25 kg m ( -2 ) ) middle-aged and older adults ( aged 45-76 years at enrollment ) with type 2 diabetes ( n = 964 ) at four clinics in Look AHEAD , a trial evaluating an intensive lifestyle intervention ( ILI ) designed to achieve weight loss through caloric restriction and increased physical activity compared to diabetes support and education ( DSE ) , underwent standardized assessments of performance-based physical function including an expanded short physical performance battery ( SPPBexp ) , 20-m and 400-m walk , and grip and knee extensor strength 8 years post-randomization , during the trial 's weight maintenance phase .
-RESULTS	Eight years post-randomization , individuals randomized to ILI had better SPPBexp scores [ adjusted mean ( SE ) difference : 0.055 ( 0.022 ) , P = 0.01 ] and faster 20-m and 400-m walk speeds [ 0.032 ( 0.012 ) m s ( -1 ) , P = 0.01 , and 0.025 ( 0.011 ) m s ( -1 ) , P = 0.02 , respectively ] compared to those randomized to DSE .
-RESULTS	Achieved weight loss greatly attenuated the group differences in physical function , and the intervention effect was no longer significant .
-CONCLUSIONS	An intensive lifestyle intervention has long-term benefits for mobility function in overweight and obese middle-aged and older individuals with type 2 diabetes .
-
-###25496176
-CONCLUSIONS	Although children vaccinated with heptavalent pneumococcal conjugate vaccine ( PCV ) had fewer episodes of acute otitis media ( AOM ) , this trial was unable to prove a simultaneous decrease in nasopharyngeal carriage .
-OBJECTIVE	Carriage rates of AOM pathogens in the nasopharynx are high among children , and colonization is the first step towards infection .
-OBJECTIVE	The possible impact of PCV on carriage is therefore of interest , particularly in children with recurrent AOM .
-OBJECTIVE	The aims of this study were to examine the effect of heptavalent PCV on carriage of AOM pathogens in children at high risk of developing recurrent disease , and to monitor carriage of resistant pathogens in vaccinated and unvaccinated children .
-METHODS	A total of 109 children with an onset of AOM before 6 months of age , 89 of whom developed recurrent disease , were enrolled in a trial .
-METHODS	Fifty-two children were vaccinated and all were closely monitored for 3 years .
-RESULTS	There was no difference statistically between vaccinated children and controls concerning the carriage of any of the major AOM pathogens .
-RESULTS	There was evidence of within-child clustering for S. pneumoniae ( p = 0.002 ) and H. influenzae ( p < 0.001 ) , indicating that children continued to carry either species over time .
-RESULTS	Resistance rates were generally low and comparable with national levels .
-
-###25953020
-OBJECTIVE	Locoregional anesthesia is an effective method for evaluating cerebral function during carotid endarterectomy ( CEA ) .
-OBJECTIVE	Landmark-guided regional anesthesia ( RA ) is currently used for CEA and can provoke substantial perioperative hypertension .
-OBJECTIVE	Ultrasound-guided RA ( US-RA ) is a new method for performing RA in CEA ; however , the effect on sympathetic activity and blood pressure is uncertain .
-OBJECTIVE	This study assessed early sympathetic activity during CEA in US-RA compared with general anesthesia ( GA ) .
-METHODS	Patients were prospectively randomized to receive US-RA ( n = 32 ) or GA ( n = 28 ) for CEA .
-METHODS	The primary end point was the change in systolic arterial blood pressure after induction of anesthesia ( just before starting surgery ) comparing US-RA with GA. .
-METHODS	We also recorded heart rate and analyzed concentrations of plasma blood hormones , including cortisol , metanephrine , and normetanephrine at five different times .
-METHODS	Creatinine kinase , troponin I , and N-terminal pro-B-type natriuretic peptide were analyzed to detect potential changes in cardiac biomarkers during the procedure .
-RESULTS	Systolic arterial blood pressure ( mean standard deviation ) increased significantly in US-RA patients compared with GA patients even before surgery was initiated ( 180 26 mm Hg vs 109 24 mm Hg ; P < .001 ) , then remained elevated during the entire surgery and returned to baseline values 1 hour after admission to the postoperative anesthesia care unit .
-RESULTS	Heart rate ( US-RA : 78 16 beats/min , GA : 52 12 beats/min ; P < .001 ) and cortisol levels ( US-RA : 155 97 g/L , GA : 99 43 g/L ; P = .006 ) were also significantly higher in the US-RA group after induction of anesthesia .
-RESULTS	Other values did not differ .
-CONCLUSIONS	The US-RA technique for CEA induces temporary intraoperative hypertension and an increase in stress hormone levels .
-CONCLUSIONS	Nevertheless , US-RA is a feasible , effective , and safe form of locoregional for CEA that enables targeted placement of low volumes of local anesthesia under direct visualization .
-
-###25884724
-BACKGROUND	Adults living in the sunny Australian climate are at high risk of skin cancer , but vitamin D deficiency ( defined here as a serum 25-hydroxyvitamin D ( 25 ( OH ) D ) concentration of less than 50 nmol/L ) is also common .
-BACKGROUND	Vitamin D deficiency may be a risk factor for a range of diseases .
-BACKGROUND	However , the optimal strategies to achieve and maintain vitamin D adequacy ( sun exposure , vitamin D supplementation or both ) , and whether sun exposure itself has benefits over and above initiating synthesis of vitamin D , remain unclear .
-BACKGROUND	The Sun Exposure and Vitamin D Supplementation ( SEDS ) Study aims to compare the effectiveness of sun exposure and vitamin D supplementation for the management of vitamin D insufficiency , and to test whether these management strategies differentially affect markers of immune and cardio-metabolic function .
-METHODS	The SEDS Study is a multi-centre , randomised controlled trial of two different daily doses of vitamin D supplementation , and placebo , in conjunction with guidance on two different patterns of sun exposure .
-METHODS	Participants recruited from across Australia are aged 18-64 years and have a recent vitamin D test result showing a serum 25 ( OH ) D level of 40-60 nmol/L .
-CONCLUSIONS	This paper discusses the rationale behind the study design , and considers the challenges but necessity of data collection within a non-institutionalised adult population , in order to address the study aims .
-CONCLUSIONS	We also discuss the challenges of participant recruitment and retention , ongoing engagement of referring medical practitioners and address issues of compliance and participant retention .
-BACKGROUND	Australia New Zealand Clinical Trials Registry : ACTRN12613000290796 Registered 14 March 2013 .
-
-###24585423
-OBJECTIVE	Patching of the operative eye is occasionally used in pediatric strabismus surgery .
-OBJECTIVE	The primary purpose of this study was to investigate the psychological and physiologic effects of patching after operation by multifactorial methods .
-METHODS	We analyzed the perioperative behaviors of 61 children with strabismus conducted from June 2012 to July 2013 in this prospective longitudinal study .
-METHODS	The children were randomized into 2 groups .
-METHODS	Patients in the patching group underwent postoperative patching and others received no patching .
-METHODS	Main outcome measures included The Faces Pain Scale-Revised score or numerical rating scales score , Children 's Hospital of Eastern Ontario Pain Scale ( CHEOPS ) score , crying time , and preoperative and postoperative physiologic parameters .
-RESULTS	Crying time was significantly longer in the patching group than in the no patching group , but self-report scores showed no difference in the groups .
-RESULTS	Repeated-measures analysis of variance on ranks revealed that postoperative CHEOPS score was lower in the no patching group than in the patching group , whereas no physiologic parameters were significantly different in the 2 groups .
-CONCLUSIONS	Patching is not necessary for reducing postoperative pain or the risk of infection in children undergoing strabismus surgery .
-
-###25266425
-OBJECTIVE	To assess the effect of a physical activity ( PA ) intervention on brain and behavioral indices of executive control in preadolescent children .
-METHODS	Two hundred twenty-one children ( 7-9 years ) were randomly assigned to a 9-month afterschool PA program or a wait-list control .
-METHODS	In addition to changes in fitness ( maximal oxygen consumption ) , electrical activity in the brain ( P3-ERP ) and behavioral measures ( accuracy , reaction time ) of executive control were collected by using tasks that modulated attentional inhibition and cognitive flexibility .
-RESULTS	Fitness improved more among intervention participants from pretest to posttest compared with the wait-list control ( 1.3 mL/kg per minute , 95 % confidence interval [ CI ] : 0.3 to 2.4 ; d = 0.34 for group difference in pre-to-post change score ) .
-RESULTS	Intervention participants exhibited greater improvements from pretest to posttest in inhibition ( 3.2 % , 95 % CI : 0.0 to 6.5 ; d = 0.27 ) and cognitive flexibility ( 4.8 % , 95 % CI : 1.1 to 8.4 ; d = 0.35 for group difference in pre-to-post change score ) compared with control .
-RESULTS	Only the intervention group increased attentional resources from pretest to posttest during tasks requiring increased inhibition ( 1.4 V , 95 % CI : 0.3 to 2.6 ; d = 0.34 ) and cognitive flexibility ( 1.5 V , 95 % CI : 0.6 to 2.5 ; d = 0.43 ) .
-RESULTS	Finally , improvements in brain function on the inhibition task ( r = 0.22 ) and performance on the flexibility task correlated with intervention attendance ( r = 0.24 ) .
-CONCLUSIONS	The intervention enhanced cognitive performance and brain function during tasks requiring greater executive control .
-CONCLUSIONS	These findings demonstrate a causal effect of a PA program on executive control , and provide support for PA for improving childhood cognition and brain health .
-
-###24567516
-BACKGROUND	Recurrent and/or metastatic squamous cell carcinoma of the head and neck ( R/M-SCCHN ) overexpresses v5 integrin .
-BACKGROUND	Cilengitide selectively inhibits v3 and v5 integrins and is investigated as a treatment strategy .
-METHODS	The phase I/II study ADVANTAGE evaluated cilengitide combined with cisplatin , 5-fluorouracil , and cetuximab ( PFE ) in R/M-SCCHN .
-METHODS	The phase II part reported here was an open-label , randomized , controlled trial investigating progression-free survival ( PFS ) .
-METHODS	Patients received up to six cycles of PFE alone or combined with cilengitide 2000 mg once ( CIL1W ) or twice ( CIL2W ) weekly .
-METHODS	Thereafter , patients received maintenance therapy ( cilengitide arms : cilengitide plus cetuximab ; PFE-alone arm : cetuximab only ) until disease progression or unacceptable toxicity .
-RESULTS	One hundred and eighty-two patients were treated .
-RESULTS	Median PFS per investigator read was similar for CIL1W + PFE , CIL2W + PFE , and PFE alone ( 6.4 , 5.6 , and 5.7 months , respectively ) .
-RESULTS	Accordingly , median overall survival and objective response rates were not improved with cilengitide ( 12.4 months/47 % , 10.6 months/27 % , and 11.6 months/36 % , respectively ) .
-RESULTS	No clinically meaningful safety differences were observed between groups .
-RESULTS	None of the tested biomarkers ( expression of integrins , CD31 , Ki-67 , vascular endothelial growth factor receptor 2 , vascular endothelial-cadherin , type IV collagen , epidermal growth factor receptor , or p16 for human papillomavirus ) were predictive of outcome .
-CONCLUSIONS	Neither of the cilengitide-containing regimens demonstrated a PFS benefit over PFE alone in R/M-SCCHN patients .
-
-###24942531
-OBJECTIVE	The purpose of this secondary analysis was to determine changes in physical inactivity from baseline to 5 years and to identify factors associated with and predictive of physical inactivity among individuals with type 2 diabetes enrolled in the Detection of Ischemia in Asymptomatic Diabetics ( DIAD ) study .
-METHODS	DIAD was a prospective randomized screening trial that assessed the prevalence of silent ischemia in asymptomatic patients with type 2 diabetes .
-METHODS	Subjects were recruited from diabetes and primary care practices at 14 centers throughout the United States and Canada .
-METHODS	This is a secondary data analysis of the physical activity data ( type and hours/week ) collected .
-METHODS	No intervention was conducted .
-RESULTS	In all subjects , physical inactivity rose from 24 % at baseline to 33 % at 5 years ( S = 28.93 ; P < .0001 ) .
-RESULTS	This change was significant in both men ( S = 11.44 ; P < .0001 ) , increasing from 23 % to 31 % , and women ( S = 18.05 ; P < .0001 ) , increasing from 25 % to 36 % .
-RESULTS	Gender differences were noted in several factors associated with baseline physical inactivity as well as in factors predictive of physical inactivity at 5 years .
-RESULTS	Important factors associated at both time points included lower level of education , current employment , presence of peripheral and autonomic neuropathy , and indicators of overweight/obesity .
-RESULTS	Baseline physical inactivity was strongly predictive of physical inactivity at 5 years ( odds ratio , 3.27 ; 95 % confidence interval , 2.36-4 .54 ; P < .0001 ) .
-CONCLUSIONS	Gender-related differences were noted in factors associated with and predictive of physical inactivity .
-
-###24774442
-BACKGROUND	We have previously observed that intravaginal prasterone ( dehydroepiandrosterone , DHEA ) improved all domains of female sexual dysfunction ( FSD ) .
-OBJECTIVE	Investigate the influence of moderate/severe pain at sexual activity ( dyspareunia ) ( MSD ) at baseline on FSD following prasterone administration .
-METHODS	The effect of daily administration of prasterone ( 0 , 3.25 mg , 6.5 mg or 13mg ) for 12 weeks on FSD in 215 postmenopausal women with or without MSD at baseline was evaluated in a prospective , randomized , double-blind , and placebo-controlled phase III clinical trial .
-METHODS	Differences were examined on desire , arousal and orgasm .
-RESULTS	Comparable benefits were observed in women not having MSD ( n = 56 ) vs. those having MSD ( n = 159 ) .
-RESULTS	The benefits over placebo in prasterone-treated women for desire , avoiding intimacy and vaginal dryness as well as for the total sexual domain of the MENQOL ( Menopause Specific Quality of Life ) questionnaire , ranged between 18.0 % and 38.2 % with P values of < 0.05 or < 0.01 except in one out of 12 subgroups .
-RESULTS	For the arousal/sensation , arousal/lubrication and summary score of the ASF ( Abbreviated Sexual Function ) questionnaire , in the MSD + group , improvements of 64.2 % ( P = 0.01 ) , 118 % ( P = 0.001 ) and 31.1 % ( P = 0.03 ) were observed over placebo , respectively , while similar differences ( 58.0 % , 67.6 % and 32.1 % ) did not reach statistical significance in the MSD - group having up to only 44 prasterone-treated women compared with 119 in the MSD + group .
-CONCLUSIONS	No MSD at baseline does not apparently affect the effects of intravaginal prasterone on sexual dysfunction .
-CONCLUSIONS	Knowing the absence of significant effects of estrogens on FSD , the present data suggest that vulvovaginal atrophy ( VVA ) and vulvovaginal sexual dysfunction ( VVSD ) are two different consequences of sex steroid deficiency at menopause which can respond independently .
-CONCLUSIONS	In addition , the present data seriously question the justification of pain being part of FSD as well as the separation of FSD into separate domains .
-
-###24309414
-BACKGROUND	Supportive supervision is a form of supervision that promotes quality at all levels of health system by strengthening relationships within the system through prompt identification and resolution of problems among others .
-BACKGROUND	It is an effective intervention in improving health worker performance in low resource settings .
-BACKGROUND	Malaria is responsible for majority of outpatient consultations in Nigeria at all levels of care .
-METHODS	This was a facility-based interventional study with pre and post-intervention phases conducted among two groups.The study subjects were selected through a multistage sampling technique and data collection was done using both semistructured interviewer administered questionnaire and supervisory checklist .
-RESULTS	The mean knowledge scores of malaria within the intervention group showed an increase from 10.3 1.4 at preintervention to 11.3 1.5 at post-intervention ( P < 0.0015 ) .
-RESULTS	The proportion of respondents who correctly followed malaria management guidelines increased from 32.73 % at first supervisory visit to 70.91 % by the third supervisory visit ( P < 0.001 ) .
-RESULTS	An analysis of the supervisory checklist showed improvement in performance of healthcare workers with each supportive supervisory visit in most of the variables examined .
-CONCLUSIONS	This study has demonstrated that supportive supervision is a feasible and practicable tool in improving knowledge and practice of malaria case management among PHC workers .
-
-###25027157
-BACKGROUND	Functional neck/shoulder stiffness is one of the most well-known indications for acupuncture treatment in Japan .
-BACKGROUND	There is little evidence for the effectiveness of acupuncture treatment for functional neck/shoulder stiffness .
-BACKGROUND	Research using two different placebos may allow an efficient method to tease apart the components of real acupuncture from various kinds of ` non-specific ' effects such as ritual with touch or ritual alone .
-BACKGROUND	Herein , we describe a protocol of an ongoing , single-centre , randomised , placebo-controlled trial which aims to assess whether , in functional neck/shoulder stiffness , acupuncture treatment with skin piercing has a specific effect over two types of placebo : skin-touching plus ritual or ritual alone .
-METHODS	Six acupuncturists and 400 patients with functional neck/shoulder stiffness are randomly assigned to four treatment groups : genuine acupuncture penetrating the skin , skin-touch placebo or no-touch placebo needles in a double-blind manner ( practitioner-patient blinding ) or no-treatment control group .
-METHODS	Each acupuncturist applies a needle to each of four acupoints ( Bladder10 , Small Intestine14 , Gallbladder21 and Bladder42 ) in the neck/shoulder to 50 patients .
-METHODS	Before , immediately after and 24 hours after the treatment , patients are asked about the intensity of their neck/shoulder stiffness .
-METHODS	After the treatment , practitioners and patients are asked to guess whether the treatment is `` penetrating '' , `` skin-touch '' or `` no-touch '' or to record `` can not identify the treatment '' .
-CONCLUSIONS	In addition to intention-to-treat analysis , we will conduct subgroup analysis based on practitioners ' or patients ' guesses to discuss the efficacy and effectiveness of treatments with skin piercing and various placebo controls .
-CONCLUSIONS	The results of practitioner and patient blinding will be discussed .
-CONCLUSIONS	We believe this study will further distinguish the role of different components of acupuncture .
-BACKGROUND	Current Controlled Trial ISRCTN76896018 .
-
-###25450993
-OBJECTIVE	The aim of this study was to compare the effects of 4 weeks of CT and AT , which training impulse ( total external workload and perceived exertion ) , are similar on power associated at VO2 peak ( pVO2 peak ) and cardiorespiratory responses of patient with CAD .
-METHODS	Eighteen male with CAD ( 62 7 years , 175 2 cm , 84 16 kg , fraction of ejection = 0.49 0.16 ) performed 4 weeks of CT ( n = 9 ) or AT ( n = 9 ) .
-METHODS	pVO2 peak , maximal and first ventilatory threshold values of oxygen uptake ( VO2 peak , VO2-vt ) and heart rate ( HRmax , HR-vt ) were measured before and after training session .
-METHODS	Total training impulse ( exercise rehabilitation and other paramedical actions ) were evaluated and harmonized between AT and CT according to Foster et al. formula ( 1996 ) RESULTS : No significant difference were found in training impulse between AT and CT ( 3650 220 vs 3497 190 U , P = NS ) .
-METHODS	VO2 pic increased after AT ( 16.9 4.4 vs 18.9 4.9 mL O2/min/kg , P < 0.05 ) and remained unchanged after CT ( 17.7 7.8 vs 17.8 7.2 , P = NS ) .
-METHODS	Four weeks of training induced significant increase in pVO2 peak , VO2-vt and FC-vt , expressed in absolute or relative value ( P < 0,05 ) , without any difference between AT and CT modalities ( P = NS ) .
-CONCLUSIONS	Improving pVO2 pic following an exercise training does not necessarily preclude an improvement in coronary VO2 pic .
-CONCLUSIONS	pVO2 peak was not improved with the same cardiorespiratory adaptations between AT and CT. .
-CONCLUSIONS	Thus , there seems important to measure gas exchanges of subject with CAD during the incremental test and identify the respective part of muscular and cardiorespiratory functions in exercise exhaustion .
-
-###24433682
-BACKGROUND	The UK lags behind many European countries in terms of cancer survival .
-BACKGROUND	Initiatives to address this disparity have focused on barriers to presentation , symptom recognition , and referral for specialist investigation .
-BACKGROUND	Selection of patients for further investigation has come under particular scrutiny , although preferences for referral thresholds in the UK population have not been studied .
-BACKGROUND	We investigated preferences for diagnostic testing for colorectal , lung , and pancreatic cancers in primary-care attendees .
-METHODS	In a vignette-based study , researchers recruited individuals aged at least 40 years attending 26 general practices in three areas of England between Dec 6 , 2011 , and Aug 1 , 2012 .
-METHODS	Participants completed up to three of 12 vignettes ( four for each of lung , pancreatic , and colorectal cancers ) , which were randomly assigned .
-METHODS	The vignettes outlined a set of symptoms , the risk that these symptoms might indicate cancer ( 1 % , 2 % , 5 % , or 10 % ) , the relevant testing process , probable treatment , possible alternative diagnoses , and prognosis if cancer were identified .
-METHODS	Participants were asked whether they would opt for diagnostic testing on the basis of the information in the vignette .
-RESULTS	3469 participants completed 6930 vignettes .
-RESULTS	3052 individuals ( 88 % ) opted for investigation in their first vignette .
-RESULTS	We recorded no strong evidence that participants were more likely to opt for investigation with a 1 % increase in risk of cancer ( odds ratio [ OR ] 102 , 95 % CI 099-106 ; p = 0189 ) , although the association between risk and opting for investigation was strong when colorectal cancer was analysed alone ( 108 , 103-113 ; p = 00001 ) .
-RESULTS	In multivariable analysis , age had an effect in all three cancer models : participants aged 60-69 years were significantly more likely to opt for investigation than were those aged 40-59 years , and those aged 70 years or older were less likely .
-RESULTS	Other variables associated with increased likelihood of opting for investigation were shorter travel times to testing centre ( colorectal and lung cancers ) , a family history of cancer ( colorectal and lung cancers ) , and higher household income ( colorectal and pancreatic cancers ) .
-CONCLUSIONS	Participants in our sample expressed a clear preference for diagnostic testing at all risk levels , and individuals want to be tested at risk levels well below those stipulated by UK guidelines .
-CONCLUSIONS	This willingness should be considered during design of cancer pathways , particularly in primary care .
-CONCLUSIONS	The public engagement with our study should encourage general practitioners to involve patients in referral decision making .
-BACKGROUND	The National Institute for Health Research Programme Grants for Applied Research programme .
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-###24462735
-OBJECTIVE	Little is known about the benefit of antiviral therapy for hepatitis B e antigen ( HBeAg ) - positive patients with high viral load and normal levels of alanine aminotransferase .
-OBJECTIVE	We evaluated the effects of single and combination therapies in immune-tolerant patients with chronic hepatitis B.
-METHODS	In a double-blind study , nucleos ( t ) ide-nave patients with high levels of hepatitis B virus ( HBV ) DNA who were positive for HBeAg and had normal levels of alanine aminotransferase were randomly assigned to groups given either oral tenofovir disoproxil fumarate ( TDF , 300 mg ) and placebo ( n = 64 ) or a combination of TDF ( 300 mg ) and emtricitabine ( 200 mg , n = 62 ) for 192 weeks .
-METHODS	The primary end point was proportion of patients with serum levels of HBV DNA < 69 IU/mL at week 192 .
-RESULTS	The study population ( mean age was 33 years ; 89 % were Asian ) was predominantly infected with HBV genotypes B and C ( 93 % ) , 99 % were HBeAg positive with a mean baseline level of HBV DNA of 8.41 log10 IU/mL .
-RESULTS	At week 192 , 55 % of patients ( 35 of 64 ) in the TDF + placebo group and 76 % of patients ( 47 of 62 ) in the TDF + emtricitabine group had levels of HBV DNA < 69 IU/mL ( P = .016 ) .
-RESULTS	No patients were found to have viral resistance to therapy .
-RESULTS	HBeAg seroconversion occurred in 3 patients ( 5 % ) , all in the TDF + placebo group ; no patient had loss of hepatitis B surface antigen .
-RESULTS	In multivariate analysis , female sex ( odds ratio = 7.05 ; P = .002 ) and TDF + emtricitabine treatment ( odds ratio = 3.9 ; P = .01 ) were associated with a favorable response .
-RESULTS	Both regimens were well tolerated .
-CONCLUSIONS	In HBeAg-positive patients with chronic HBV infection , high viral loads , normal levels of alanine aminotransferase , and therapy with the combination of TDF and emtricitabine provided better viral suppression than TDF alone , although rates of HBeAg seroconversion and hepatitis B surface antigen loss were low .
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-###25363100
-BACKGROUND	Routine immunization is a key child survival intervention .
-BACKGROUND	Issues related to quality of service delivery pose operational challenges in delivering effective immunization services .
-BACKGROUND	Accumulated evidences suggest that `` supportive supervision '' improves the quality of health care services .
-BACKGROUND	During 2009-10 , Govt .
-BACKGROUND	of Odisha ( GoO ) and UNICEF jointly piloted this strategy in four districts to improve routine immunization .
-BACKGROUND	The present study aims to assess the effect of supportive supervision strategy on improvement of knowledge and practices on routine immunization among service providers .
-METHODS	We adopted a ` post-test only ' study design to compare the knowledge and practices of frontline health workers and their supervisors in four intervention districts with that of two control districts .
-METHODS	Altogether we interviewed 170 supervisors and supervisees ( health workers ) , each , using semi-structured interview schedules .
-METHODS	We also directly observed 25 ice lined refrigerator ( ILR ) points in both groups of districts .
-METHODS	The findings were compared with the baseline information , available only for the intervention districts .
-RESULTS	The health workers in the intervention districts displayed a higher knowledge score in selected items than in the control group .
-RESULTS	No significant difference in knowledge was observed between control and intervention supervisors .
-RESULTS	The management practices at ILR points on key routine immunization components were found to have improved significantly in intervention districts .
-CONCLUSIONS	The observed improvements in the ILR management practices indicate positive influence of supportive supervision .
-CONCLUSIONS	Higher level of domain knowledge among intervention health workers on specific items related to routine immunization could be due to successful transfer of knowledge from supervisors .
-CONCLUSIONS	A ` pre-post ' study design should be undertaken to gain insights into the effectiveness of supportive supervision in improving routine immunization services .
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-###24356474
-BACKGROUND	Previous global studies examined etanercept ( ETN ) + methotrexate ( MTX ) for treatment of rheumatoid arthritis ( RA ) , but included few subjects from Latin America .
-OBJECTIVE	The objective of this study was to compare the safety and efficacy of ETN + MTX versus a standard-of-care disease-modifying antirheumatic drug ( DMARD ) + MTX in Latin American subjects with moderate to severe active RA despite MTX therapy .
-METHODS	This open-label , active-comparator study ( NCT00848354 ) randomized subjects 2:1 to ETN 50 mg/wk + MTX or investigator-selected DMARD ( sulfasalazine or hydroxychloroquine ) + MTX ( ETN + MTX , n = 281 ; DMARD + MTX , n = 142 ) .
-METHODS	The primary end point was the proportion achieving American College of Rheumatology ( ACR ) 50 at week 24 .
-METHODS	Secondary end points included ACR20/70 , disease activity score ( DAS ) 28 measures , and mean change in modified total Sharp score .
-METHODS	Patient-reported outcomes were the Health Assessment Questionnaire , 36-item Short-Form , Hospital Anxiety and Depression Scale , Work Productivity and Activity Impairment : RA ( WPAI : RA ) , and Caregiver Burden and Resource Utilization .
-METHODS	Statistical analyses were stratified by country ; test and analysis of covariance were used .
-METHODS	Adverse events were monitored .
-RESULTS	More subjects achieved ACR50 at week 24 with ETN + MTX versus DMARD + MTX ( 62 % vs 23 % , respectively ) , in addition to secondary end points ( P < 0.0001 for all ) ; mean change in modified total Sharp score was lower for the ETN + MTX group ( 0.4 vs 1.4 , respectively ; P = 0.0270 ) .
-RESULTS	Improvements in patient-reported outcomes favored ETN + MTX for Health Assessment Questionnaire , 36-item Short-Form , Hospital Anxiety and Depression Scale for depression , WPAI : RA , and Caregiver Burden and Resource Utilization emergency department visits for RA ( P < 0.01 ) .
-RESULTS	Overall , adverse events were similar between the groups ( 69 % vs 68 % , ) ; serious adverse events were also similar ( 4 % vs 1 % ) .
-RESULTS	The rate of overall infections was higher with ETN + MTX ( 38 % ) than DMARD + MTX ( 22 % , P 0.001 ) .
-CONCLUSIONS	Consistent with published global data among RA patients with inadequate response to MTX , adding ETN to MTX demonstrated better efficacy than adding one other conventional DMARD to MTX .
-CONCLUSIONS	No new safety issues were observed .
-CONCLUSIONS	ETN + MTX provided favorable benefit-risk profile among RA patients from LA region .
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-###24984211
-BACKGROUND	Despite national guidelines recommending bone mineral density screening with dual-energy x-ray absorptiometry ( DXA ) in women aged 65 years and older , many women do not receive initial screening .
-OBJECTIVE	To determine the effectiveness of health system and patient-level interventions designed to increase appropriate DXA testing and osteoporosis treatment through ( 1 ) an invitation to self-refer for DXA ( self-referral ) ; ( 2 ) self-referral plus patient educational materials ; and ( 3 ) usual care ( UC , physician referral ) .
-METHODS	Parallel , group-randomized , controlled trials performed at Kaiser Permanente Northwest ( KPNW ) and Kaiser Permanente Georgia ( KPG ) .
-METHODS	Women aged 65 years and older without a DXA in past 5 years .
-METHODS	DXA completion rates 90 days after intervention mailing and osteoporosis medication receipt 180 days after initial intervention mailing .
-RESULTS	From > 12,000 eligible women , those randomized to self-referral were significantly more likely to receive a DXA than UC ( 13.0 % -24.1 % self-referral vs. 4.9 % -5.9 % UC , P < 0.05 ) .
-RESULTS	DXA rates did not significantly increase with patient educational materials .
-RESULTS	Osteoporosis was detected in a greater proportion of self-referral women compared with UC ( P < 0.001 ) .
-RESULTS	The number needed to receive an invitation to result in a DXA in KPNW and KPG regions was approximately 5 and 12 , respectively .
-RESULTS	New osteoporosis prescription rates were low ( 0.8 % -3.4 % ) but significantly greater among self-referral versus UC in KPNW .
-CONCLUSIONS	DXA rates significantly improved with a mailed invitation to schedule a scan without physician referral .
-CONCLUSIONS	Providing women the opportunity to self-refer may be an effective , low-cost strategy to increase access for recommended osteoporosis screening .
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-###26042485
-OBJECTIVE	Budesonide formoterol ( BF ) Spiromax is a breath-actuated dry-powder inhaler designed to deliver similar combinations of budesonide and formoterol as Symbicort Turbohaler .
-OBJECTIVE	We performed two studies to demonstrate pharmacokinetic ( PK ) equivalence of BF Spiromax with BF Turbohaler .
-METHODS	Two single-center , open-label , randomized , 5-period crossover studies were performed .
-METHODS	The first study compared BF Spiromax 160/4 .5 g with BF Turbohaler 200/6 g , while the second study compared BF Spiromax 320/9 g with BF Turbohaler 400/12 g. All treatments were administered with and without charcoal .
-METHODS	PK parameters were calculated by measuring plasma drug concentrations from blood samples taken pre-dose and up to 24 hours post-dose .
-RESULTS	In each study , 90 healthy volunteers were randomized .
-RESULTS	Bioequivalence of BF Spiromax with BF Turbohaler was demonstrated for budesonide and formoterol ( AUC0-t and Cmax ( 90 % confidence intervals of the geometric mean between-device ratios for both parameters were within the predefined range of 0.80-1 .25 in both studies ) ) .
-RESULTS	Equivalence was observed without use of charcoal ( overall absorption post-inhalation ) and with charcoal ( pulmonary absorption ) .
-RESULTS	There were no major differences between treatments in tmax for either budesonide or formoterol .
-RESULTS	All study treatments were well tolerated ( one treatment-emergent adverse event ( TEAE ) in the medium-dose study and four TEAEs in the high-dose study ) .
-CONCLUSIONS	These studies indicate that BF Spiromax ( charcoal block ) is bioequivalent to BF Turbohaler with respect to the PK parameters assessed .
-CONCLUSIONS	Single doses of BF Spiromax were well tolerated ; the overall safety profile of BF Spiromax and BF Turbohaler was similar .
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-###25580060
-BACKGROUND	Noncystic fibrosis bronchiectasis ( NCFB ) is characterized by airway expansion and recurrent acute exacerbations .
-BACKGROUND	Macrolide has been shown to exhibit anti-inflammatory effects in some chronic airway diseases .
-OBJECTIVE	To assess the efficacy of roxithromycin on airway inflammation and remodeling in patients with NCFB under steady state .
-METHODS	The study involved an open-label design in 52 eligible Chinese patients with NCFB , who were assigned to control ( receiving no treatment ) and roxithromycin ( receiving 150mg/day for 6 months ) groups .
-METHODS	At baseline and 6 months , the inflammatory markers such as interleukin - ( IL - ) 8 , neutrophil elastase ( NE ) , matrix metalloproteinase - ( MMP ) 9 , hyaluronidase ( HA ) , and type IV collagen in sputum were measured , along with the detection of dilated bronchus by throat computed tomography scan , and assessed the exacerbation .
-RESULTS	Forty-three patients completed the study .
-RESULTS	The neutrophil in the sputum was decreased in roxithromycin group compared with control ( P < 0.05 ) .
-RESULTS	IL-8 , NE , MMP-9 , HA , and type IV collagen in sputum were also decreased in roxithromycin group compared with the control group ( all P < 0.01 ) .
-RESULTS	Airway thickness of dilated bronchus and exacerbation were reduced in roxithromycin group compared with the control ( all P < 0.05 ) .
-CONCLUSIONS	Roxithromycin can reduce airway inflammation and airway thickness of dilated bronchus in patients with NCFB .
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-###24442926
-OBJECTIVE	CAM2028 , a vehicle that forms a bioadhesive lipid barrier when applied to the oral mucosa , was developed as a carrier system for local delivery of benzydamine , an NSAID used for pain relief in oral mucositis .
-OBJECTIVE	This trial compared the analgesic effect of CAM2028 plus benzydamine ( CAM2028-benzydamine ) with unmedicated CAM2028 ( CAM2028-control ) for the treatment of oral mucositis in patients with head-and-neck cancer .
-METHODS	Thirty-eight study participants were enrolled during their 3rd to 4th week of radiation therapy .
-METHODS	Participants were required to have symptomatic oral mucositis ( WHO Grade 2 or above ) at screening and pain scores of at least 6 on an 11-point Likert scale at screening and on each day before treatment with study medication .
-METHODS	After undergoing radiation , patients were administered a single dose of CAM2028-control or CAM2028-benzydamine 2 days apart , in a randomized crossover fashion .
-METHODS	Pain was assessed over the following 8 h.
-RESULTS	With both treatments , patients experienced a mean 40 % decrease in pain intensity at 6 h ( the primary study endpoint ) .
-RESULTS	Both treatments resulted in significant pain relief within 5 min of application that was evident during the entire 8-h assessment period .
-RESULTS	There was no difference in pain relief between the two interventions at any time point .
-RESULTS	Both treatments were safe and well tolerated .
-CONCLUSIONS	CAM2028-benzydamine and CAM2028-control were both efficacious in reducing pain in patients with oral mucositis related to radiation therapy for head-and-neck cancer .
-CONCLUSIONS	Analgesic effects of both medications were immediate , clinically significant , and persistent for up to 8 h.
-
-###24519752
-OBJECTIVE	The aim of this study was to characterize trastuzumab population pharmacokinetics ( PKs ) in patients with human epidermal growth factor receptor 2-positive advanced gastric or gastroesophageal junction cancer and the relationship of trastuzumab PK with patient response .
-METHODS	A nonlinear mixed effects PK model was built using data from the ToGA study .
-METHODS	Patients were randomized to intravenous trastuzumab plus chemotherapy or chemotherapy alone .
-METHODS	The influence of demographic , laboratory , and disease characteristics on PK parameters was assessed .
-METHODS	An exploratory exposure-response analysis compared various PK parameters at steady state with best overall tumor response and overall survival ( OS ) .
-RESULTS	Trastuzumab PK was best described by a two-compartment model with parallel linear and nonlinear ( Michaelis-Menten ) elimination from the central compartment .
-RESULTS	Total clearance ( and half-life ) of trastuzumab was concentration-dependent .
-RESULTS	Body weight , prior gastrectomy , and serum albumin had the greatest influence on trastuzumab PK ; increasing weight and decreasing albumin levels were associated with increased clearance , while prior gastrectomy correlated with decreased clearance .
-RESULTS	Median values for AUC , Cmax , and Cmin were lower in patients with progressive disease ( PD ) than other response categories , although the 1.5 interquartile ranges overlapped .
-RESULTS	Patients with the lowest Cmin had the highest PD rate and a shorter OS .
-CONCLUSIONS	In the advanced gastric cancer population , trastuzumab PK was best described by a two-compartment model with parallel linear and nonlinear elimination .
-CONCLUSIONS	Predicted PK exposure was lower than previously reported for breast cancer .
-CONCLUSIONS	Patients with the lowest Cmin had a shorter OS and the highest PD rate , but a distinct correlation was not observed for tumor response .
-
-###24567266
-BACKGROUND	Whilst surgery will face an imminent workforce shortage , an increasing majority of students decide against a surgical career .
-BACKGROUND	This study evaluated the current career expectations of medical students and tested a hands-on virtual reality ( VR ) intervention as a tool to increase their interest in surgery .
-METHODS	Randomly selected medical students of the University of Basel received a short questionnaire to rank their interest in five different postgraduate working environments prior to a lecture .
-METHODS	After the lecture they participated in a hands-on VR demonstration .
-METHODS	Thereafter an online questionnaire regarding workplace expectations , surgery and VR was sent to the students .
-RESULTS	The online questionnaire response rate was 87 % ( 225/258 ) .
-RESULTS	Before using the VR intervention , a nonsurgical career was preferred by the majority of students , followed by a surgical career , cross-disciplinary specialties , research and , finally , nonclinical work .
-RESULTS	Surgery ( n = 99 , 44 % ) and emergency medicine ( n = 111 , 49 % ) were rated as incompatible with a good work-life balance .
-RESULTS	Further drawbacks to surgery were apprehension of competitive mentality , unclear career perspectives and longer working hours .
-RESULTS	The VR intervention had limited impact on re-ranking the five working sectors and slightly increased the students ' interest in surgery .
-CONCLUSIONS	Students ' work environment expectations , their declining interest in a surgical career and the increasing need for surgeons represent challenges for surgical societies to address , in order to improve the attractiveness of surgery amongst students .
-CONCLUSIONS	VR sessions may be integrated as part of the actions required to improve students ' interest in a surgical career and should be further evaluated within controlled study designs .
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-###24512909
-OBJECTIVE	The comparative efficacy and safety of infliximab and azathioprine therapy alone or in combination for ulcerative colitis ( UC ) have not been evaluated previously .
-METHODS	This randomized , double-blind trial evaluated the efficacy and safety of 16 weeks of treatment with infliximab monotherapy , azathioprine monotherapy , or the 2 drugs combined in tumor necrosis factor-a antagonist-naive adults with moderate to severe UC .
-METHODS	Patients were assigned randomly to receive intravenous infusions of infliximab 5 mg/kg at weeks 0 , 2 , 6 , and 14 plus daily oral placebo capsules ; oral azathioprine 2.5 mg/kg daily plus placebo infusions on the infliximab schedule ; or combination therapy with the 2 drugs .
-METHODS	Corticosteroid-free clinical remission ( primary end point , week 16 ) was evaluated at weeks 8 and 16 .
-METHODS	The study was terminated before the enrollment target was reached .
-RESULTS	A total of 239 patients were included in efficacy analyses .
-RESULTS	Baseline characteristics were similar between treatment groups .
-RESULTS	Corticosteroid-free remission at week 16 was achieved by 39.7 % ( 31 of 78 ) of patients receiving infliximab/azathioprine , compared with 22.1 % ( 17 of 77 ) receiving infliximab alone ( P = .017 ) and 23.7 % ( 18 of 76 ) receiving azathioprine alone ( P = .032 ) .
-RESULTS	Mucosal healing at week 16 occurred in 62.8 % ( 49 of 78 ) of patients receiving infliximab/azathioprine , compared with 54.6 % ( 42 of 77 ) receiving infliximab ( P = .295 ) and 36.8 % ( 28 of 76 ) receiving azathioprine ( P = .001 ) .
-RESULTS	Serious infections occurred in 2 patients ( 1 patient receiving infliximab , and 1 patient receiving azathioprine ) .
-CONCLUSIONS	Antitumor necrosis factor-anaive patients with moderate to severe UC treated with infliximab plus azathioprine were more likely to achieve corticosteroid-free remission at 16 weeks than those receiving either monotherapy .
-CONCLUSIONS	Combination therapy led to significantly better mucosal healing than azathioprine monotherapy .
-CONCLUSIONS	ClinicalTrials.gov number , NCT00537316 .
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-###24719128
-OBJECTIVE	Prolonged duration of cardiopulmonary bypass aggravates the degree of inflammation and coagulopathy .
-OBJECTIVE	We investigated the influence of 6 % hydroxyethyl starch ( HES ) 130/0 .4 on coagulation and inflammation compared with albumin when used for both cardiopulmonary bypass priming and perioperative fluid therapy in patients undergoing complex valvular heart surgery .
-METHODS	Fifty four patients were randomly allocated into albumin-HES , albumin-nonHES , and HES-HES groups .
-METHODS	The cardiopulmonary bypass circuit was primed with 5 % albumin in the albumin-HES and albumin-nonHES group , and with HES in the HES-HES group .
-METHODS	As perioperative fluid , only plasmalyte was used in the albumin-nonHES group whereas HES was used up to 20 mL/kg in the albumin-HES and albumin-HES group .
-METHODS	Serial assessments of coagulation profiles using the rotational thromboelastometry and inflammatory markers ( tissue necrosis factor - , interleukin-6 , and interleukin-8 ) were performed .
-RESULTS	Patients ' characteristics and the duration of cardiopulmonary bypass ( albumin-HES ; 13734 min , HES-HES ; 13647 min , albumin-nonHES ; 13239 min ) were all similar among the groups .
-RESULTS	Postoperative coagulation profiles demonstrated sporadic increases in clot formation time and coagulation time , without any differences in the actual amount of perioperative bleeding and transfusion requirements among the groups .
-RESULTS	Also , inflammatory markers showed significant activation after cardiopulmonary bypass without any differences among the groups .
-CONCLUSIONS	Even in the presence of prolonged duration of cardiopulmonary bypass , HES seemed to yield similar influence on the ensuing coagulopathy and inflammatory response when used for priming and perioperative fluid therapy following complex valvular heart surgery compared with conventional fluid regimen including albumin and plasmalyte .
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-###24307559
-OBJECTIVE	To assess the reproducibility of brain-activation and eye-movement patterns in a saccade paradigm when comparing subjects , tasks , and magnetic resonance ( MR ) systems .
-METHODS	Forty-five healthy adults at two different sites ( n = 45 ) performed saccade tasks with varying levels of target predictability : predictable ( PRED ) , position predictable ( pPRED ) , time predictable ( tPRED ) , and prosaccade ( SAC ) .
-METHODS	Eye-movement pattern was tested with a repeated-measures analysis of variance .
-METHODS	Activation maps reproducibility were estimated with the cluster overlap Jaccard index and signal variance coefficient of determination for within-subjects test-retest data , and for between-subjects data from the same and different sites .
-RESULTS	In all groups latencies increased with decreasing target predictability : PRED < pPRED < tPRED < SAC ( P < 0,001 ) .
-RESULTS	Activation overlap was good to fair ( > 0.40 ) in all tasks in the within-subjects test-retest comparisons and poor ( < 0.40 ) in the tPRED for different subjects .
-RESULTS	The overlap of the different tasks for within-groups data was higher ( 0.40-0 .68 ) than for the between-groups data ( 0.30-0 .50 ) .
-RESULTS	Activation consistency was 60-85 % in the same subjects , 50-79 % in different subjects , and 50-80 % in different sites .
-RESULTS	In SAC , the activation found in the same and in different subjects was more consistent than in other tasks ( 50-80 % ) .
-CONCLUSIONS	The predictive saccade tasks produced evidence for brain-activation and eye-movement reproducibility .
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-###24971591
-OBJECTIVE	The cortisol awakening response ( CAR ) is a natural metabolic response that can be potentiated by negative cognitive-emotional processes , including stress appraisals , negative affect , and rumination .
-OBJECTIVE	Psychological distress and the CAR are not consistently related , however .
-OBJECTIVE	Individual differences in aspects of dispositional mindfulness which reflect how people relate to negative thoughts and emotions may help explain such inconsistencies .
-OBJECTIVE	We tested whether the tendency to ( 1 ) label and describe inner experiences and ( 2 ) accept negative thoughts and feelings without judgment moderated the association between psychological distress and the CAR .
-METHODS	Self-reported dispositional mindfulness , perceived stress , anxiety , negative affect , rumination , and the CAR were assessed among overweight/obese women .
-METHODS	Regression analyses were conducted to examine whether dispositional mindfulness moderated the relationship between indicators of psychological distress and the CAR .
-RESULTS	While psychological distress was consistently positively related to the CAR , these associations were qualified by significant interactions with both components of dispositional mindfulness .
-RESULTS	Psychological distress was associated with the CAR at lower levels of dispositional mindfulness but not at higher levels .
-CONCLUSIONS	These findings are consistent with the idea that the tendency to describe and accept experiences may buffer the impact of psychological distress on physiological arousal .
-CONCLUSIONS	These metacognitive processes may be important moderators in unraveling the complex relationship between psychological distress and physiological stress reactivity .
-CONCLUSIONS	Further research is recommended to replicate this approach in other populations .
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-###24471750
-OBJECTIVE	To evaluate intra-articular autologous protein solution ( APS ) for the treatment of osteoarthritis in horses .
-OBJECTIVE	Animals-40 client-owned horses with naturally occuring osteoarthritis .
-METHODS	APS was generated from a dual-device system that concentrated plasma and WBC proteins and enriched platelet growth factors .
-METHODS	Horses were randomly assigned to receive an intra-articular injection of 5 mL of saline ( 0.9 % NaCl ) solution ( n = 20 ) or APS ( 20 ) , exercised on a treadmill , and evaluated on the basis of lameness grades , kinetic gait analysis , joint circumference , and range of motion for 14 days .
-METHODS	Horses that received saline solution were administered APS at termination of the study , and clients scored horses for lameness and discomfort before , 12 weeks after , and 52 weeks after the APS injection .
-RESULTS	The APS group had significant improvements in lameness grade , asymmetry indices of vertical peak force , and range of joint motion by 14 days , compared with baseline or control group values .
-RESULTS	No adverse effects associated with APS treatment were evident .
-RESULTS	Clients assessed lameness and comfort as improved at 12 and 52 weeks .
-RESULTS	The APS had greater likelihood ( OR , 4.3 to 30.0 ) of a therapeutic response in horses with a lameness score < 4 , < 10 % vertical force asymmetry , or absence of marked osteophyte formation , subchondral sclerosis , or joint space narrowing .
-RESULTS	Concentration of interleukin-1 receptor antagonist in APS was 5.8 times that in blood .
-CONCLUSIONS	Intra-articular administration of APS can be considered an effective treatment option for equine osteoarthritis , with the potential for disease-modifying effects .
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-###25897039
-BACKGROUND	Consistent evidence suggests that obstructive sleep apnoea ( OSA ) is associated with increased cardiovascular risk .
-BACKGROUND	However , it is unclear whether OSA is underdiagnosed in the cardiology outpatient setting .
-BACKGROUND	In the present study , we prospectively evaluated the potential underdiagnosis of OSA in several subspecialties from a tertiary cardiology university hospital .
-METHODS	Consecutive outpatients from five subspecialties ( hypertension , coronary , arrhythmia , heart failure ( HF ) , valvular heart disease ) were studied .
-METHODS	We performed anthropometric measurements , assessed the risk of OSA using the Berlin Questionnaire and evaluated the prior diagnosis and treatment for OSA .
-METHODS	In a subset of patients randomly selected , we performed portable sleep monitoring to objectively evaluate the presence of OSA ( defined by an apnoea-hypopnoea index 15 events/h of sleep ) .
-RESULTS	We evaluated 500 patients ( 100 from each subspecialty ) .
-RESULTS	The mean age and body mass index ( BMI ) were 5913years and 28.25.3 kg/m ( 2 ) , respectively .
-RESULTS	We found that 51.6 % ( 258 patients ) had a high risk for OSA ( Berlin Questionnaire ) .
-RESULTS	However , only 13 ( 3.1 % ) of these patients had a previous diagnosis of OSA .
-RESULTS	Of those , only six patients were receiving specific OSA treatment .
-RESULTS	Fifty patients ( 10 from each specialty ) participated in sleep studies .
-RESULTS	No differences were found in patients who underwent sleep monitoring and those who did not .
-RESULTS	We found a high frequency of OSA ( 66 % ) , varying from 50 % ( hypertension group ) to 80 % ( HF group ) .
-CONCLUSIONS	Despite significant scientific evidence pointing to OSA as an emerging cardiovascular risk factor , OSA is still underdiagnosed in several cardiology subspecialties .
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-###24835303
-OBJECTIVE	To compare two concentrations of ropivacaine administered for tumescent local anesthesia ( TLA ) in dogs undergoing mastectomy .
-METHODS	Prospective randomized clinical study .
-METHODS	Seventeen bitches of various breeds , aged 122years and weighing 106.5 kg requiring total unilateral or bilateral mastectomy .
-METHODS	Dogs were premedicated with acepromazine ( 0.04 mgkg ( -1 ) ) and morphine ( 0.4 mgkg ( -1 ) ) intramuscularly .
-METHODS	Anesthesia was induced with propofol ( 2.5 mgkg ( -1 ) ) and midazolam ( 0.2 mgkg ( -1 ) ) intravenously , followed by intubation and maintenance with isoflurane and TLA .
-METHODS	Dogs were randomly allocated to receive TLA either with 0.1 % ropivacaine ( group G1 ) or with 0.05 % ropivacaine ( group G05 ) .
-METHODS	TLA was performed by insertion of a multihole needle under the skin and infusion of ropivacaine and lactated Ringer 's solution at a fixed volume of 15mLkg ( -1 ) .
-METHODS	Ropivacaine concentrations in arterial blood were measured by high-performance liquid chromatography .
-METHODS	Post-operative pain was assessed using two scales ( University of Melbourne pain scale and a modified composite measure pain scale ) and von Frey filaments , 4hours after TLA and at 1hour intervals until sensitivity was regained .
-METHODS	A score above 30 % of the maximum possible score was considered a positive indicator of pain .
-RESULTS	Peak plasma concentrations of ropivacaine were measured 240minutes after TLA in G1 .
-RESULTS	Low concentrations were measured in G05 for 60minutes , with subsequent increase .
-RESULTS	Analgesic rescue and return of sensitivity occurred at 72.3 and 71.9 hours ( mean SD ) after TLA for G1 and G05 , respectively .
-CONCLUSIONS	Tumescent local anesthesia with ropivacaine provided satisfactory post-operative analgesia that lasted for several hours , with no difference in duration between the concentrations .
-CONCLUSIONS	No serious side effects were attributed to TLA .
-CONCLUSIONS	Results indicated that 0.05 % ropivacaine provided adequate analgesia for mastectomy , however , more studies are required to support this conclusion .
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-###24562806
-OBJECTIVE	ST-segment resolution ( STR ) after reperfusion therapy has been shown to correlate with prognosis in patients with ST-segment elevation myocardial infarction ( STEMI ) .
-OBJECTIVE	We investigated whether acute ECG measurements also correlate with ultimate infarct size .
-RESULTS	The INFUSE-AMI trial randomized 452 patients with anterior STEMI to intracoronary bolus abciximab vs. no abciximab , and to thrombus aspiration vs. no aspiration .
-RESULTS	Infarct size as percentage of total LV mass was calculated by cardiac magnetic resonance imaging ( MRI ) 30 days post intervention .
-RESULTS	Five ECG methods were analysed for their ability to predict MRI infarct mass : ( 1 ) summed STR across all infarct-related ECG leads ( STR ) ; ( 2 ) STR in the single lead with maximum baseline ST-segment elevation ( maxSTR ) ; ( 3 ) summed residual ST-segment elevation across all infarct-related leads at 60 min post intervention ( ST residual ) ; ( 4 ) maximum residual ST-segment elevation in the worst single lead at 60 min post intervention ( maxST residual ) ; ( 5 ) number of new significant Q-waves ( Qwave ) at 60 min .
-RESULTS	All ECG methods strongly correlated with 30-day MRI infarct mass ( all p < 0.003 ) .
-RESULTS	Simpler ECG measurements such as maxSTresidual and Qwave were as predictive as more complex measurements .
-RESULTS	A subset analysis of 158 patients who had microvascular obstruction ( MVO ) determined by MRI 5 days post intervention also showed strong correlations of MVO with the ECG measures .
-CONCLUSIONS	ST-segment and Q-wave changes after primary PCI in anterior STEMI strongly correlated with 30-day infarct size by MRI .
-CONCLUSIONS	In particular , maxST residual and Qwave at 60 min are simple ECG parameters that offer rapid analysis for prognostication .
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-###25095886
-BACKGROUND	The quality of evidence for invasive revascularization in intermittent claudication is low or very low .
-BACKGROUND	This prospective , randomized , controlled study tested the hypothesis that an invasive treatment strategy versus continued noninvasive treatment improves health-related quality of life after 1 year in unselected patients with intermittent claudication .
-RESULTS	After clinical and duplex ultrasound assessment , unselected patients with intermittent claudication requesting treatment for claudication were randomly assigned to invasive ( n = 79 ) or noninvasive ( n = 79 ) treatment groups .
-RESULTS	Primary end point was health-related quality of life after 1 year , assessed with Medical Outcomes Study Short Form 36 version 1 and Vascular Quality of Life Questionnaire , and secondary end points included walking distances on a graded treadmill .
-RESULTS	The Medical Outcomes Study Short Form 36 version 1 physical component summary ( P < 0.001 ) and 2 Medical Outcomes Study Short Form 36 version 1 physical subscales improved significantly more in the invasive versus the noninvasive treatment group .
-RESULTS	Overall , Vascular Quality of Life Questionnaire score ( P < 0.01 ) and 3 of 5 domain scores improved significantly more in the invasive versus the noninvasive treatment group .
-RESULTS	Intermittent claudication distance improved significantly in the invasive ( +124 m ) versus the noninvasive ( +50 m ) group ( P = 0.003 ) , whereas the change in maximum walking distance was not significantly different between groups .
-CONCLUSIONS	An invasive treatment strategy improves health-related quality of life and intermittent claudication distance after 1 year in patients with stable lifestyle-limiting claudication receiving current medical management .
-CONCLUSIONS	Long-term follow-up data and health-economic assessments are warranted to further establish the role for revascularization in intermittent claudication .
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-###25863654
-BACKGROUND	Macrosomic fetuses are at increased risk of shoulder dystocia .
-BACKGROUND	We aimed to compare induction of labour with expectant management for large-for-date fetuses for prevention of shoulder dystocia and other neonatal and maternal morbidity associated with macrosomia .
-METHODS	We did this pragmatic , randomised controlled trial between Oct 1 , 2002 , and Jan 1 , 2009 , in 19 tertiary-care centres in France , Switzerland , and Belgium .
-METHODS	Women with singleton fetuses whose estimated weight exceeded the 95th percentile , were randomly assigned ( 1:1 ) , via computer-generated permuted-block randomisation ( block size of four to eight ) to receive induction of labour within 3 days between 37 ( +0 ) weeks and 38 ( +6 ) weeks of gestation , or expectant management .
-METHODS	Randomisation was stratified by centre .
-METHODS	Participants and caregivers were not masked to group assignment .
-METHODS	Our primary outcome was a composite of clinically significant shoulder dystocia , fracture of the clavicle , brachial plexus injury , intracranial haemorrhage , or death .
-METHODS	We did analyses by intention to treat .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT00190320 .
-RESULTS	We randomly assigned 409 women to the induction group and 413 women to the expectant management group , of whom 407 women and 411 women , respectively , were included in the final analysis .
-RESULTS	Mean birthweight was 3831 g ( SD 324 ) in the induction group and 4118 g ( 392 ) in the expectant group .
-RESULTS	Induction of labour significantly reduced the risk of shoulder dystocia or associated morbidity ( n = 8 ) compared with expectant management ( n = 25 ; relative risk [ RR ] 032 , 95 % CI 015-071 ; p = 0004 ) .
-RESULTS	We recorded no brachial plexus injuries , intracranial haemorrhages , or perinatal deaths .
-RESULTS	The likelihood of spontaneous vaginal delivery was higher in women in the induction group than in those in the expectant management group ( RR 114 , 95 % CI 101-129 ) .
-RESULTS	Caesarean delivery and neonatal morbidity did not differ significantly between the groups .
-CONCLUSIONS	Induction of labour for suspected large-for-date fetuses is associated with a reduced risk of shoulder dystocia and associated morbidity compared with expectant management .
-CONCLUSIONS	Induction of labour does not increase the risk of caesarean delivery and improves the likelihood of spontaneous vaginal delivery .
-CONCLUSIONS	These benefits should be balanced with the effects of early-term induction of labour .
-BACKGROUND	Assistance Publique-Hpitaux de Paris and the University of Geneva .
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-###24656636
-BACKGROUND	Elevated concentrations of doxorubicin are found in eccrine sweat glands of the palms and soles .
-BACKGROUND	We therefore evaluated an antiperspirant as preventive treatment for palmar-plantar erythrodysesthesia ( hand-foot syndrome ) in patients with metastatic breast cancer treated with pegylated liposomal doxorubicin .
-METHODS	An antiperspirant containing aluminum chlorohydrate or placebo cream was applied to the left or right hand and foot in a double-blinded manner ( intra-patient randomization ) .
-METHODS	The primary endpoint was the rate of grade 2 or 3 palmar-plantar erythrodysesthesia .
-METHODS	A secondary endpoint was the patient-reported symptom burden ( tingling , numbness , pain , or skin problems ) .
-METHODS	Using McNemar 's matched pairs design , 53 patients were needed to detect a 20 % difference between the treatment and placebo sides with a significance level of 5 % and power of 90 % .
-RESULTS	Grade 2 or 3 PPE occurred in 30 ( 58 % ) of 52 evaluable patients ; in six patients adverse effects occurred on the placebo side but not on the treatment side , whereas one patient developed palmar-plantar erythrodysesthesia on the treatment side only ( P = 0.07 ) .
-RESULTS	Four patients developed grade 2 or 3 palmar-plantar erythrodysesthesia on their foot on the placebo side but not on the treatment side ( P = 0.05 ) .
-RESULTS	In the cohort with grade 2 or 3 palmar-plantar erythrodysesthesia there was a trend towards fewer dermatologic symptomatologies with the active treatment ( P = 0.05 ) , and no difference for other adverse events .
-CONCLUSIONS	Using topical aluminum chlorohydrate as an antiperspirant appears to reduce the incidence of grade 2 or 3 palmar-plantar erythrodysesthesia following pegylated liposomal doxorubicin chemotherapy for metastatic breast cancer .
-
-###24941177
-BACKGROUND	Methotrexate is the most frequently used first-line antirheumatic drug .
-BACKGROUND	We report the findings of a phase 3 study of monotherapy with tofacitinib , an oral Janus kinase inhibitor , as compared with methotrexate monotherapy in patients with rheumatoid arthritis who had not previously received methotrexate or therapeutic doses of methotrexate .
-METHODS	We randomly assigned 958 patients to receive 5 mg or 10 mg of tofacitinib twice daily or methotrexate at a dose that was incrementally increased to 20 mg per week over 8 weeks ; 956 patients received a study drug .
-METHODS	The coprimary end points at month 6 were the mean change from baseline in the van der Heijde modified total Sharp score ( which ranges from 0 to 448 , with higher scores indicating greater structural joint damage ) and the proportion of patients with an American College of Rheumatology ( ACR ) 70 response ( 70 % reduction in the number of both tender and swollen joints and 70 % improvement in three of five other criteria : the patient 's assessment of pain , level of disability , C-reactive protein level or erythrocyte sedimentation rate , global assessment of disease by the patient , and global assessment of disease by the physician ) .
-RESULTS	Mean changes in the modified total Sharp score from baseline to month 6 were significantly smaller in the tofacitinib groups than in the methotrexate group , but changes were modest in all three groups ( 0.2 points in the 5-mg tofacitinib group and < 0.1 point in the 10-mg tofacitinib group , as compared with 0.8 points in the methotrexate group [ P < 0.001 for both comparisons ] ) .
-RESULTS	Among the patients receiving tofacitinib , 25.5 % in the 5-mg group and 37.7 % in the 10-mg group had an ACR 70 response at month 6 , as compared with 12.0 % of patients in the methotrexate group ( P < 0.001 for both comparisons ) .
-RESULTS	Herpes zoster developed in 31 of 770 patients who received tofacitinib ( 4.0 % ) and in 2 of 186 patients who received methotrexate ( 1.1 % ) .
-RESULTS	Confirmed cases of cancer ( including three cases of lymphoma ) developed in 5 patients who received tofacitinib and in 1 patient who received methotrexate .
-RESULTS	Tofacitinib was associated with increases in creatinine levels and in low-density and high-density lipoprotein cholesterol levels .
-CONCLUSIONS	In patients who had not previously received methotrexate or therapeutic doses of methotrexate , tofacitinib monotherapy was superior to methotrexate in reducing signs and symptoms of rheumatoid arthritis and inhibiting the progression of structural joint damage .
-CONCLUSIONS	The benefits of tofacitinib need to be considered in the context of the risks of adverse events .
-CONCLUSIONS	( Funded by Pfizer ; ORAL Start ClinicalTrials.gov number , NCT01039688 . )
-
-###25257064
-BACKGROUND	Depression is common and the efficacy of antidepressants is suboptimal .
-BACKGROUND	High plasma homocysteine has been consistently associated with depression , and treatment with certain B vitamins demonstrably reduces its concentration .
-OBJECTIVE	To determine whether vitamins B6 , B12 and folic acid enhance response to antidepressant treatment over 52 weeks .
-METHODS	Randomised , double-blind , placebo-controlled trial of citalopram ( 20-40 g ) together with 0.5 mg of vitamin B12 , 2 mg of folic acid and 25 mg of vitamin B6 for 52 weeks ( Australian and New Zealand Clinical Trials Registry : 12609000256279 ) .
-METHODS	Participants were community-dwelling adults aged 50 years or over with DSM-IV-TR major depression .
-METHODS	We measured severity of symptoms with the Montgomery-sberg Depression Rating Scale ( MADRS ) .
-METHODS	The primary outcome was remission of the depressive episode after 12 , 26 and 52 weeks .
-METHODS	Secondary outcomes included reduction of MADRS scores over time and relapse of major depression after recovery by week 12 .
-METHODS	Results In total , 153 people were randomised ( 76 placebo , 77 vitamins ) .
-METHODS	Remission of symptoms was achieved by 78.1 and 79.4 % of participants treated with placebo and vitamins by week 12 ( P = 0.840 ) , by 76.5 and 85.3 % at week 26 and 75.8 and 85.5 % at week 52 ( effect of intervention over 52 weeks : odds ratio ( OR ) = 2.49 , 95 % CI 1.12-5 .51 ) .
-METHODS	Group differences in MADRS scores over time were not significant ( P = 0.739 ) .
-METHODS	The risk of subsequent relapse among those who had achieved remission of symptoms at week 12 was lower in the vitamins than placebo group ( OR = 0.33 , 95 % CI 0.12-0 .94 ) .
-CONCLUSIONS	B vitamins did not increase the 12-week efficacy of antidepressant treatment , but enhanced and sustained antidepressant response over 1 year .
-CONCLUSIONS	Replication of these findings would mandate that treatment guidelines adopt the adjunctive use of B vitamins as a safe and inexpensive strategy to manage major depression in middle-aged and older adults .
-
-###25627340
-OBJECTIVE	The Veterans Administration Cooperative Studies Program # 468 , a multicenter study that randomized Parkinson 's disease ( PD ) patients to either subthalamic nucleus ( STN ) or globus pallidus internus ( GPi ) deep brain stimulation ( DBS ) , found that stimulation at either target provided similar overall motoric benefits .
-OBJECTIVE	We conducted an additional analysis of this data set to evaluate whether PD motor subtypes responded differently to the 2 stimulation targets .
-METHODS	We classified 235 subjects by motor subtype : tremor dominant ( TD ) , intermediate ( I ) , or postural instability gait difficulty ( PIGD ) , based on pre-DBS baseline Unified Parkinson 's Disease Rating Scale ( UPDRS ) scores off-medication .
-METHODS	The primary outcome was change in UPDRS part III ( UPDRS-III ) off-medication scores from baseline to 24 months post-DBS , compared among subjects with particular PD motor subtypes and by DBS target ( STN vs GPi ) .
-METHODS	Changes in tremor , rigidity , akinesia , and gait scores were also assessed using the UPDRS .
-RESULTS	TD patients had greater mean overall motor improvement , measured by UPDRS-III , after GPi DBS , compared to STN DBS ( 17.513.0 vs 14.614.9 , p = 0.02 ) , with improvement in gait accounting for this difference .
-RESULTS	Regardless of stimulation target , PIGD subjects had lower mean overall improvement in UPDRS-III scores compared with I or TD subjects ( 8.712.2 vs 21.711.2 vs 16.313.8 , p = 0.001 ) .
-CONCLUSIONS	Our results suggest that responsiveness to both GPi and STN DBS is similar among different PD motor subtypes , although the TD motor subtype may have a greater response to GPi DBS with respect to gait .
-CONCLUSIONS	PIGD patients obtained less overall benefit from stimulation .
-
-###25465711
-OBJECTIVE	To compare the six-month outcome of three different ultrasound-guided treatments for de Quervain 's disease ( DQD ) .
-METHODS	We prospectively treated 75 consecutive patients ( 51 females , 24 males , mean age standard deviation = 45.39.8 years ) with DQD .
-METHODS	Patients ' features ( hand dominance , intraretinaculum septum , accessory tendons ) were recorded .
-METHODS	Visual analogue scale ( VAS ) , reduced disability ( quickDASH ) score , and retinaculum thickness were evaluated at baseline and after one ( excluding retinaculum thickness ) , three , and six months .
-METHODS	Patients were randomized into three groups of 25 patients each treated under ultrasound guidance : Group A ( 1 ml methylprednisolone acetate ; mean baseline thickness = 1.6 mm ; mean baseline VAS = 6 ; mean baseline quickDASH = 55 ) ; Group B ( 1 ml methylprednisolone acetate +15 - day delayed 2 ml saline 0.9 % ; 1.4 ; 6 ; 56 ) ; Group C ( 1 ml methylprednisolone acetate +15 - day delayed 2 ml low molecular weight hyaluronic acid ; 1.7 ; 6 ; 55 ) .
-RESULTS	After one month results were : Group A mean VAS = 2 ; mean quickDASH = 23 ; Group B 2 ; 22 ; Group C 2 ; 21 .
-RESULTS	After three months results were : Group A retinaculum thickness = 0.7 mm ; 3 ; 27 ) ; Group B 0.8 mm ; 1 ; 25 ; Group C 0.5 mm ; 1 ; 23 .
-RESULTS	After six months results were : Group A 1.5 mm ; 3 ; 51 ; Group B 1 mm ; 2 ; 51 ; Group C 0.7 mm ; 1 ; 26 ( P < 0.001 for all vs. baseline ) .
-RESULTS	Patients ' age , sex , hand dominance , presence of subcompartment dividing septum , and supernumerary tendons had no influence on outcome ( P 0.177 ) .
-CONCLUSIONS	Addition of hyaluronic acid to ultrasound-guided injections of steroids to treat DQD seems to improve the outcome and to reduce the recurrence rate .
-CONCLUSIONS	Ultrasound guidance allows for safe injection procedures to treat de Quervains ' disease Steroid injections allow prompt recovery in de Quervain 's disease with short-term recurrence Addition of hyaluronic acid allows recurrence rate reduction compared to simple steroid injections .
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-###25354581
-BACKGROUND	Older individuals often have a reduced immune response to influenza vaccination , which might be improved by administering a higher vaccine dose .
-BACKGROUND	We compared the immune response to two single doses of the AS03A-adjuvanted H5N1 pandemic vaccine ( 3.75 g hemagglutinin of A/Vietnam/1194 / 2004 ) with that of two double vaccine doses ( 7.5 g hemagglutinin ) in adults aged 61 years .
-BACKGROUND	Here we report the 2-year persistence of the humoral and cellular immune response .
-METHODS	In this phase II , open-label study , healthy participants aged 61 to 88 years ( median 68 years ) were randomised ( 3:1:3:1 ) to receive two single doses of the AS03A-adjuvanted vaccine ( 1xH5N1-AS ) or the non-adjuvanted vaccine ( 1xH5N1 ) , or two double doses of the AS03A-adjuvanted vaccine ( 2xH5N1-AS ) or the non-adjuvanted vaccine ( 2xH5N1 ) , 21 days apart .
-METHODS	Serum haemagglutination inhibition antibodies and cellular immune responses against A/Vietnam/1194 / 2004 were measured in all groups at months 12 and 24 ; neutralising antibodies were assessed in a subset of the adjuvanted groups .
-METHODS	Serious adverse events and adverse events of specific interest were recorded .
-RESULTS	At month 24 , haemagglutination inhibition antibody seroprotection rates were 37.2 % ( 95 % CI 27.0 % to 48.3 % ) for 1xH5N1-AS , 30.9 % ( 95 % CI 21.1 % to 42.1 % ) for 2xH5N1-AS , 16.2 % ( 95 % CI 6.2 % to 32.0 % ) for 1xH5N1 , and 8.3 % ( 95 % CI 1.0 % to 27.0 % ) for 2xH5N1 .
-RESULTS	Haemagglutination inhibition antibody geometric mean titres were 17.6 ( 95 % CI 13.7 to 22.5 ) for 1xH5N1-AS , 18.4 ( 95 % CI 14.2 to 23.8 ) for 2xH5N1-AS , 12.3 ( 95 % CI 8.9 to 16.9 ) for 1xH5N1 and 9.8 ( 95 % CI 6.7 to 14.4 ) for 2xH5N1 .
-RESULTS	The median frequency of antigen-specific CD4 + T cells per 106 T cells ( 25th quartile ; 75th quartile ) was 852 ( 482 ; 1477 ) for 1xH5N1-AS , 1147 ( 662 ; 1698 ) for 2xH5N1-AS , 556 ( 343 ; 749 ) for 1x-H5N1 and 673 ( 465 ; 1497 ) for 2xH5N1 .
-RESULTS	Neutralising antibody geometric mean titres were 391.0 ( 95 % CI 295.5 to 517.5 ) in the 1xH5N1-AS group and 382.8 ( 95 % CI 317.4 to 461.6 ) in the 2xH5N1-AS group .
-CONCLUSIONS	Antibody levels declined substantially in all groups .
-CONCLUSIONS	Seroprotection rates , geometric mean titres for haemagglutination inhibition antibodies , and CD4 + T-cell responses tended to be higher in the AS03A-adjuvanted groups .
-CONCLUSIONS	There was no clear benefit , in terms of long-term persistence of the immune response , of doubling the dose of the adjuvanted vaccine .
-CONCLUSIONS	No safety concern was observed up to 24 months post-primary vaccination .
-BACKGROUND	NCT00397215 ( 7 November 2006 ) .
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-###24824051
-BACKGROUND	School-based mass treatment with praziquantel is the cornerstone for schistosomiasis control in school-aged children .
-BACKGROUND	However , uptake of treatment among school-age children in Uganda is low in some areas .
-BACKGROUND	The objective of the study was to examine the effectiveness of a pre-treatment snack on uptake of mass treatment .
-RESULTS	In a cluster randomized trial carried out in Jinja district , Uganda , 12 primary schools were randomized into two groups ; one received education messages for schistosomiasis prevention for two months prior to mass treatment , while the other , in addition to the education messages , received a pre-treatment snack shortly before mass treatment .
-RESULTS	Four weeks after mass treatment , uptake of praziquantel was assessed among a random sample of 595 children in the snack schools and 689 children in the non-snack schools as the primary outcome .
-RESULTS	The occurrence of side effects and the prevalence and mean intensity of Schistosoma mansoni infection were determined as the secondary outcomes .
-RESULTS	Uptake of praziquantel was higher in the snack schools , 93.9 % ( 95 % CI 91.7 % -95.7 % ) , compared to that in the non-snack schools , 78.7 % ( 95 % CI 75.4 % -81.7 % ) ( p = 0.002 ) .
-RESULTS	The occurrence of side effects was lower in the snack schools , 34.4 % ( 95 % CI 31.5 % -39.8 % ) , compared to that in the non-snack schools , 46.9 % ( 95 % CI 42.2 % -50.7 % ) ( p = 0.041 ) .
-RESULTS	Prevalence and mean intensity of S. mansoni infection was lower in the snack schools , 1.3 % ( 95 % CI 0.6 % -2.6 % ) and 38.3 eggs per gram of stool ( epg ) ( 95 % CI 21.8-67 .2 ) , compared to that in the non-snack schools , 14.1 % ( 95 % CI 11.6 % -16.9 % ) ( p = 0.001 ) and 78.4 epg ( 95 % CI 60.6-101 .5 ) ( p = 0.001 ) , respectively .
-CONCLUSIONS	Our results suggest that provision of a pre-treatment snack combined with education messages achieves a higher uptake compared to the education messages alone .
-CONCLUSIONS	The use a pre-treatment snack was associated with reduced side effects as well as decreased prevalence and intensity of S. mansoni infection .
-BACKGROUND	www.ClinicalTrials.gov NCT01869465
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-###25440798
-BACKGROUND	The tradeoff between stent thrombosis ( ST ) and major bleeding ( MB ) of 12 - versus 6-month dual antiplatelet therapy ( DAPT ) after coronary stent implantation has not been clearly defined .
-METHODS	Definite/probable ST and MB ( TIMI major and Bleeding Academic Research Consortium ( BARC ) 3 ) were compared in 2 subsequent trials with similar inclusion criteria but different DAPT duration , that is , BASKET ( 6 months ; n = 557 ) and BASKET-PROVE ( 12 months ; n = 2,314 ) , between months 0 to 6 ( DAPT in both trials ) , 7 to 12 ( DAPT in BASKET-PROVE only ) , and 13 to 24 ( aspirin in both trials ) using propensity score-adjusted , time-stratified Cox proportional hazard models .
-RESULTS	Overall , event rates were low with fewer ST but similar MB in prolonged DAPT .
-RESULTS	Analysis of the 3 periods showed a uniform pattern for ST ( interaction DAPT/period ; P = .145 ) but an inconsistent pattern for MB ( interaction DAPT/period ; P < .001 for TIMI major and P = .046 for BARC 3 ) , with more MB occurring during months 7 to 12 with prolonged DAPT .
-RESULTS	Considering observed case fatality rates of 31 % with ST and 11 % with MB , the extrapolated prevention of 27 ST deaths and the excess of 5 MB deaths resulted in an expected benefit of 22 survivors/10 ,000 patients treated over 2 years with prolonged DAPT .
-CONCLUSIONS	Despite overall low event rates , prolonged DAPT was associated with more MB during months 7 to 12 according to the interaction DAPT/period .
-CONCLUSIONS	Given the higher observed case fatality rates of ST versus MB , 12 - versus 6-month DAPT was associated with an extrapolated reduction in mortality .
-CONCLUSIONS	Effective treatment periods and case fatality rates seem important in the analysis of different DAPT durations , specifically with regard to ongoing trials .
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-###24581465
-OBJECTIVE	To identify risk factors for port infections within 30 days of placement .
-METHODS	A retrospective chart review of port placements from 2002-2009 was conducted .
-METHODS	Patients who had port removals secondary to infection within the first 30 days of placement were included .
-METHODS	This group of patients was compared with a control group of patients with ports with no evidence of infection .
-METHODS	For every one patient with a port infection , two control subjects were chosen of the same gender and new port placement during the same month as the corresponding patient with an infected port .
-RESULTS	From 2002-2009 , 4,404 ports were placed .
-RESULTS	Of the 4,404 patients , 33 ( 0.7 % ) were found to have a port infection within 30 days of placement .
-RESULTS	Compared with the control group , the early infection group had a higher prevalence of leukopenia ( 21.2 % vs 6.1 % , P = .039 ) and thrombocytopenia ( 33 % vs 12 % , P = .0158 ) .
-RESULTS	There was also a higher prevalence of an inpatient hospital stay during port placement and high international normalized ratio in the early infection group .
-CONCLUSIONS	Low preoperative white blood cell and platelet counts were risk factors for early infection .
-CONCLUSIONS	Abnormal coagulation profiles and inpatient access of ports after placement could be additional risk factors .
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-###24762371
-OBJECTIVE	Quality of life ( QOL ) can be considered as a quality indicator of health care systems and nurses can play an important role to improve QOL in patients with congestive heart failure ( CHF ) .
-OBJECTIVE	The aim of this study was to determine the effects of education provided by nurses on the QOL in patients with CHF in home-visit care compared to usual care .
-METHODS	In a single-blind randomized controlled trial conducted from September 2011 to June 2012 , 110 patients with CHF were randomly assigned into two groups .
-METHODS	While patients in group I were received usual education at the time of hospital discharge , patients in Group II , in addition to usual education , were received special education regards to their illness by nurses who visited patients in their homes .
-METHODS	The 36-item short-form ( SF-36 ) questionnaire was used to evaluate the patient 's QOL at the time of discharge and also six months after hospital discharge .
-RESULTS	At the time of hospital discharge , mean score of all 8 sub-score of SF-36 questionnaire was 63.47.8 in patients of group II and 61.16.4 in patients of group I , respectively ( P > 0.05 ) .
-RESULTS	QOL was decreased in group I and increased in group II compared to the time of hospital discharge .
-RESULTS	After six months , mean score of QOL was higher in group II than in group I.
-CONCLUSIONS	QOL of patients with CHF were decreased after hospital discharge .
-CONCLUSIONS	Education provided by nurses in home-visit care could improve the QOL in patients with CHF , based on the findings of this study .
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-###24248037
-BACKGROUND	Short message service ( SMS ) has been suggested as an effective method to improve adherence to medical therapy in some chronic diseases .
-BACKGROUND	However , data on the effects of SMS interventions to allergic rhinitis ( AR ) treatment is limited at present .
-BACKGROUND	We aimed to assess whether a daily SMS reminder could improve AR patients ' adherence to medication and treatment outcomes .
-METHODS	Fifty outpatients with AR were randomized to either receive ( SMS group ) or not ( control group ) a daily SMS reminder on their cell phone to take intranasal corticosteroid treatment for 30 days .
-METHODS	The primary study outcomes were self-reported adherence to medication , clinic attendance rate , and severity of AR symptoms using a visual analogue scale ( VAS ) .
-METHODS	Secondary outcomes were changes in nasal patency ( minimum cross-sectional area , nasal cavity volume , and nasal airway resistance ) and exhaled nasal nitric oxide levels .
-RESULTS	Self-reported adherence to medication in the SMS group ( 15/25 , 60 % ) , was significantly higher than in the control group ( 7/25 , 28 % , p = 0.02 ) .
-RESULTS	Similarly , the clinic attendance rate in the SMS group ( 72 % ) was significantly higher than in the control group ( 40 % , p = 0.02 ) .
-RESULTS	Although the VAS score improved significantly from baseline in both study groups , the improvement in the SMS group was significantly greater than in the control group ( 4.38 4.38 vs. 8.74 6.54 , p = 0.031 ) .
-RESULTS	No significant differences were observed between the two groups for the secondary outcomes .
-CONCLUSIONS	A daily SMS reminder may be an effective intervention to improve adherence to medication and treatment outcomes in AR patients .
-
-###26382998
-BACKGROUND	The American Academy of Pediatrics recommends a permissive hypoxaemic target for an oxygen saturation of 90 % for children with bronchiolitis , which is consistent with the WHO recommendations for targets in children with lower respiratory tract infections .
-BACKGROUND	No evidence exists to support this threshold .
-BACKGROUND	We aimed to assess whether the 90 % or higher target for management of oxygen supplementation was equivalent to a normoxic 94 % or higher target for infants admitted to hospital with viral bronchiolitis .
-METHODS	We did a parallel-group , randomised , controlled , equivalence trial of infants aged 6 weeks to 12 months of age with physician-diagnosed bronchiolitis newly admitted into eight paediatric hospital units in the UK ( the Bronchiolitis of Infancy Discharge Study [ BIDS ] ) .
-METHODS	A central computer randomly allocated ( 1:1 ) infants , in varying length blocks of four and six and without stratification , to be clipped to standard oximeters ( patients treated with oxygen if pulse oxygen saturation [ SpO2 ] < 94 % ) or modified oximeters ( displayed a measured value of 90 % as 94 % , therefore oxygen not given until SpO2 < 90 % ) .
-METHODS	All parents , clinical staff , and outcome assessors were masked to allocation .
-METHODS	The primary outcome was time to resolution of cough ( prespecified equivalence limits of plus or minus 2 days ) in the intention-to-treat population .
-METHODS	This trial is registered with ISRCTN , number ISRCTN28405428 .
-RESULTS	Between Oct 3 , and March 30 , 2012 , and Oct 1 , and March 29 , 2013 , we randomly assigned 308 infants to standard oximeters and 307 infants to modified oximeters .
-RESULTS	Cough resolved by 150 days ( median ) in both groups ( 95 % CI for difference -1 to 2 ) and so oxygen thresholds were equivalent .
-RESULTS	We recorded 35 serious adverse events in 32 infants in the standard care group and 25 serious adverse events in 24 infants in the modified care group .
-RESULTS	In the standard care group , eight infants transferred to a high-dependency unit , 23 were readmitted , and one had a prolonged hospital stay .
-RESULTS	In the modified care group , 12 infants were transferred to a high-dependency unit and 12 were readmitted to hospital .
-RESULTS	Recorded adverse events did not differ significantly .
-CONCLUSIONS	Management of infants with bronchiolitis to an oxygen saturation target of 90 % or higher is as safe and clinically effective as one of 94 % or higher .
-CONCLUSIONS	Future research should assess the benefits and risks of different oxygen saturation targets in acute respiratory infection in older children , particularly in developing nations where resources are scarce .
-BACKGROUND	National Institute for Health Research , Health Technology Assessment programme .
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-###24346989
-OBJECTIVE	Chronic periodontitis , a destructive inflammatory disorder of the supporting structures of the teeth , is prevalent in patients with diabetes .
-OBJECTIVE	Limited evidence suggests that periodontal therapy may improve glycemic control .
-OBJECTIVE	To determine if nonsurgical periodontal treatment reduces levels of glycated hemoglobin ( HbA1c ) in persons with type 2 diabetes and moderate to advanced chronic periodontitis .
-METHODS	The Diabetes and Periodontal Therapy Trial ( DPTT ) , a 6-month , single-masked , multicenter , randomized clinical trial .
-METHODS	Participants had type 2 diabetes , were taking stable doses of medications , had HbA1c levels between 7 % and less than 9 % , and untreated chronic periodontitis .
-METHODS	Five hundred fourteen participants were enrolled between November 2009 and March 2012 from diabetes and dental clinics and communities affiliated with 5 academic medical centers .
-METHODS	The treatment group ( n = 257 ) received scaling and root planing plus chlorhexidine oral rinse at baseline and supportive periodontal therapy at 3 and 6 months .
-METHODS	The control group ( n = 257 ) received no treatment for 6 months .
-METHODS	Difference in change in HbA1c level from baseline between groups at 6 months .
-METHODS	Secondary outcomes included changes in probing pocket depths , clinical attachment loss , bleeding on probing , gingival index , fasting glucose level , and Homeostasis Model Assessment ( HOMA2 ) score .
-RESULTS	Enrollment was stopped early because of futility .
-RESULTS	At 6 months , mean HbA1c levels in the periodontal therapy group increased 0.17 % ( SD , 1.0 ) , compared with 0.11 % ( SD , 1.0 ) in the control group , with no significant difference between groups based on a linear regression model adjusting for clinical site ( mean difference , -0.05 % [ 95 % CI , -0.23 % to 0.12 % ] ; P = .55 ) .
-RESULTS	Periodontal measures improved in the treatment group compared with the control group at 6 months , with adjusted between-group differences of 0.28 mm ( 95 % CI , 0.18 to 0.37 ) for probing depth , 0.25 mm ( 95 % CI , 0.14 to 0.36 ) for clinical attachment loss , 13.1 % ( 95 % CI , 8.1 % to 18.1 % ) for bleeding on probing , and 0.27 ( 95 % CI , 0.17 to 0.37 ) for gingival index ( P < .001 for all ) .
-CONCLUSIONS	Nonsurgical periodontal therapy did not improve glycemic control in patients with type 2 diabetes and moderate to advanced chronic periodontitis .
-CONCLUSIONS	These findings do not support the use of nonsurgical periodontal treatment in patients with diabetes for the purpose of lowering levels of HbA1c .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00997178 .
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-###24280465
-OBJECTIVE	To evaluate the sustaining effects of Tai chi Qigong in improving the physiological health for COPD patients at sixth month .
-METHODS	A randomized controlled trial .
-METHODS	Subjects were in three randomly assigned groups : Tai chi Qigong group , exercise group , and control group .
-METHODS	The 206 subjects were recruited from five general outpatient clinics .
-METHODS	Tai chi Qigong group completed a 3-month Tai chi Qigong program .
-METHODS	Exercise group practiced breathing and walking as an exercise .
-METHODS	Control group received usual care .
-METHODS	Primary outcomes included six-minute walking distance and lung functions .
-METHODS	Secondary outcomes were dyspnea and fatigue levels , number of exacerbations and hospital admissions .
-RESULTS	Tai chi Qigong group showed a steady improvement in exercise capacity ( P < .001 ) from baseline to the sixth month .
-RESULTS	The mean walking distance increased from 298 to 349 meters ( +17 % ) .
-RESULTS	No significant changes were noted in the other two groups .
-RESULTS	Tai chi Qigong group also showed improvement in lung functions ( P < .001 ) .
-RESULTS	Mean forced expiratory volume in 1s increased from .89 to .99 l ( +11 % ) .
-RESULTS	No significant change was noted in the exercise group .
-RESULTS	Deterioration was found in the control group , with mean volume decreased from .89 to .84 l ( -5.67 % ) .
-RESULTS	Significant decreased in the number of exacerbations was observed in the Tai chi Qigong group .
-RESULTS	No changes in dyspnea and fatigue levels were noted among the three groups .
-CONCLUSIONS	Tai chi Qigong has sustaining effects in improving the physiological health and is a useful and appropriate exercise for COPD patients .
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-###24754203
-BACKGROUND	During maneuvering , fighter pilots experience loads of up to 50-70 kg on their necks .
-BACKGROUND	Neck disorders are common and have been linked to impairment in muscle control .
-BACKGROUND	We conducted an intervention study introducing targeted training for 24 wk that reduced neck pain .
-BACKGROUND	The current study reports the results of the secondary objective , which was to increase the understanding of possible mechanisms underlying such neck pain and its intervention-related relief .
-METHODS	In a parallel , single-blinded , randomized controlled study , 55 F-16 pilots were evaluated at baseline and randomized to a control group ( CG ; N = 28 ) or training group ( TG ; N = 27 ) .
-METHODS	Postural control was tested in four different settings : Romberg with open and closed eyes , unilateral stance , and perturbation .
-METHODS	Maximal voluntary contraction and force steadiness was measured for shoulder elevation .
-RESULTS	At follow-up , there was a significant between-group difference in the Romberg test with closed eyes only ( 95 % confidence ellipse area ; CG : 761 + / - 311 mm2 ; TG : 650 + / - 405 mm2 ) .
-RESULTS	Prior to randomization , there were no significant differences in postural control and steadiness between 30 pilots who experienced neck pain within the previous 3 mo and 25 pilots without such pain .
-CONCLUSIONS	Impaired postural control and steadiness may only be quantifiable in individuals experiencing acute neck pain of certain intensity , and there may be a ceiling effect in the ability to improve these parameters .
-CONCLUSIONS	For individuals with highly developed physiological capacity , a battery of tests with more stringent demands should be considered , e.g. , increased number of repetitions , prolonged duration of the tests , or testing with eyes closed .
-
-###25140041
-OBJECTIVE	The aim of this study was to assess the degree of fluctuation of osteitis on MRI during long-term treatment with etanercept ( ETN ) in patients with early axial SpA ( axSpA ) with active inflammation ( osteitis ) on whole-body MRI in the spine and/or the SI joints at baseline .
-METHODS	We analysed MRI data from 328 SI joint quadrants and 943 spine vertebral units ( VUs ) in terms of osteitis in the pooled data set of 41 patients who were treated with ETN for 3 consecutive years .
-METHODS	Scoring was performed by two blinded radiologists at baseline , year 2 and year 3 .
-RESULTS	Through years 2 and 3 , osteitis on MRI resolved completely in 56 of 144 ( 38.9 % ) SI joint quadrants and in 20 of 40 ( 50 % ) VUs affected at baseline , while persistent osteitis was found in 24 of 144 ( 16.7 % ) SI joint quadrants and in 8 of 40 ( 20.0 % ) spine VUs .
-RESULTS	The development of new osteitis in sites that were free of osteitis at baseline only occurred in 2 of 131 ( 1.5 % ) SI joint quadrants and in 3 of 862 ( 0.4 % ) spine VUs in both year 2 and year 3 .
-CONCLUSIONS	There was a consistently small amount of osteitis on MRI in patients with early axSpA compared with baseline values , and only a very low rate of new-onset osteitis was found during 3 years of continuous treatment with ETN .
-BACKGROUND	www.clinicaltrials.gov , NCT00844142 .
-
-###24615217
-OBJECTIVE	Current tobacco use treatment approaches require smokers to request treatment or depend on the provider to initiate smoking cessation care and are therefore reactive .
-OBJECTIVE	Most smokers do not receive evidence-based treatments for tobacco use that include both behavioral counseling and pharmacotherapy .
-OBJECTIVE	To assess the effect of a proactive , population-based tobacco cessation care model on use of evidence-based tobacco cessation treatments and on population-level smoking cessation rates ( ie , abstinence among all smokers including those who use and do not use treatment ) compared with usual care among a diverse population of current smokers .
-METHODS	The Veterans Victory Over Tobacco Study , a pragmatic randomized clinical trial involving a population-based registry of current smokers aged 18 to 80 years .
-METHODS	A total of 6400 current smokers , identified using the Department of Veterans Affairs ( VA ) electronic medical record , were randomized prior to contact to evaluate both the reach and effectiveness of the proactive care intervention .
-METHODS	Current smokers were randomized to usual care or proactive care .
-METHODS	Proactive care combined ( 1 ) proactive outreach and ( 2 ) offer of choice of smoking cessation services ( telephone or in-person ) .
-METHODS	Proactive outreach included mailed invitations followed by telephone outreach to motivate smokers to seek treatment with choice of services .
-METHODS	The primary outcome was 6-month prolonged smoking abstinence at 1 year and was assessed by a follow-up survey among all current smokers regardless of interest in quitting or treatment utilization .
-RESULTS	A total of 5123 participants were included in the primary analysis .
-RESULTS	The follow-up survey response rate was 66 % .
-RESULTS	The population-level , 6-month prolonged smoking abstinence rate at 1 year was 13.5 % for proactive care compared with 10.9 % for usual care ( P = .02 ) .
-RESULTS	Logistic regression mixed model analysis showed a significant effect of the proactive care intervention on 6-month prolonged abstinence ( odds ratio [ OR ] , 1.27 [ 95 % CI , 1.03-1 .57 ] ) .
-RESULTS	In analyses accounting for nonresponse using likelihood-based not-missing-at-random models , the effect of proactive care on 6-month prolonged abstinence persisted ( OR , 1.33 [ 95 % CI , 1.17-1 .51 ] ) .
-CONCLUSIONS	Proactive , population-based tobacco cessation care using proactive outreach to connect smokers to evidence-based telephone or in-person smoking cessation services is effective for increasing long-term population-level cessation rates .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00608426 .
-
-###26115073
-OBJECTIVE	To investigate the effects of multimodal supervised exercise on physical functioning , falls , and related injuries in older women .
-METHODS	Two-year randomized controlled trial .
-METHODS	Tampere , Finland .
-METHODS	Women aged 70 to 80 who had fallen in the previous year ( n = 409 ) .
-METHODS	Participants were randomly assigned to an exercise or control group ( ClinicalTrial.gov NCT00986466 ) .
-METHODS	Exercisers participated in group exercise classes twice a week for 12 months and once a week for the subsequent 12 months and home exercises .
-METHODS	Controls maintained their current physical activity .
-METHODS	Physical functioning assessed at baseline and at 6-month intervals during the intervention .
-METHODS	Falls and related injuries monitored with fall diaries .
-RESULTS	Intention-to-treat analyses showed that exercise led to significant improvements in physical functioning .
-RESULTS	Leg strength differed significantly between the groups ( mean change : 14.1 % , 95 % confidence interval ( CI ) = 8.0 to 20.2 in exercisers ; 1.6 % , 95 % CI = -4.5 to 7.7 in controls ; P < .001 ) .
-RESULTS	Chair stand time also differed significantly between groups ( 7.4 % , 95 % CI 3.8 to 10.8 % in exercisers ; 2.4 % , 95 % CI = -1.6 to 6.2 ) in controls ; P = .02 ) .
-RESULTS	Between-group differences were significant for fast walking speed ( P = .003 ) and probability of completing the backward walking test ( P < .001 ) , favoring exercisers .
-RESULTS	Timed Up-and-Go and grip strength did not differ between groups .
-RESULTS	There was no difference in the total falls incidence rate ratio ( IRR = 1.0 , 95 % CI = 0.79 to 1.26 ) , but exercisers were less likely to have medically attended injurious falls ( IRR = 0.45 , 95 % CI = 0.27 to 0.78 ; P = .004 ) .
-CONCLUSIONS	Twenty-four months of multimodal exercise enhanced physical functioning in women aged 70 to 80 with a history of falls .
-CONCLUSIONS	Although the total number of falls was not lower than in controls , the rate of medically attended injurious falls was more than 50 % lower .
-
-###24321006
-OBJECTIVE	To test the strength of the association between parental monitoring trajectories throughout early adolescence ( ages 11-14 ) and gambling behaviours by young adulthood ( age 22 ) .
-METHODS	Longitudinal cohort design .
-METHODS	Baltimore , Maryland .
-METHODS	The sample of 514 participants with gambling data between ages 16-22 and parental monitoring data between ages 11-14 were predominantly African American and received subsidized lunches at age 6 .
-METHODS	The South Oaks Gambling Screen and South Oaks Gambling Screen-Revised for Adolescents collected self-reports on annual gambling and gambling problems between ages 16-22 .
-METHODS	The Parental Monitoring Subscale of the Structured Interview of Parent Management Skills and Practices-Youth Version collected self-reports on annual parental monitoring between ages 11-14 .
-RESULTS	General growth mixture modelling identified two parental monitoring trajectories : ( i ) ` stable ' class ( 84.9 % ) began with a high level of parental monitoring at age 11 that remained steady to age 14 ; ( ii ) ` declining ' class ( 15.1 % ) began with a significantly lower level of parental monitoring at age 11 and experienced a significant to through age 14 .
-RESULTS	The declining class had increased significantly unadjusted ( OR = 1.91 ; 95 % CI = 1.59 , 2.23 ; P0 .001 ) and adjusted ( aOR = 1.57 ; 95 % CI = 1.24 , 1.99 ; P = 0.01 ) odds of problem gambling compared with non-gambling .
-CONCLUSIONS	Low and/or declining parental monitoring of children between the ages of 11 and 14 is associated significantly with problem gambling when those children reach young adulthood .
-
-###25575084
-METHODS	Prospective randomized controlled multicenter study .
-OBJECTIVE	To compare the effect of X-Stop with minimally invasive decompression ( MID ) in patients with neurogenic intermittent claudication due to lumbar spinal stenosis .
-BACKGROUND	Lumbar spinal stenosis is the most common indication for operative treatment in elderly .
-BACKGROUND	Laminectomy has been the `` gold standard , '' but MID is now widely used .
-BACKGROUND	Another minimally invasive surgery option is X-Stop showing good result compared with nonoperative treatment , but showing higher reoperation rate than laminectomy .
-METHODS	We enrolled 96 patients aged 50 to 85 years , with symptoms of neurogenic intermittent claudication within 250-m walking distance and 1 - or 2-level lumbar spinal stenosis , randomized to either MID or X-Stop .
-METHODS	Primary outcome was Zurich Claudication Questionnaire in this intention-to-treat analysis .
-METHODS	Secondary outcome was Oswestry Disability Index , EuroQol 5-dimensional questionnaire , numerical rating scale 11 for lower back pain and leg pain , and risk for secondary surgery and complications .
-RESULTS	No significant differences were found in Zurich Claudication Questionnaire between the groups at any follow-ups .
-RESULTS	Both groups had a statistical and clinical significant improvement at 6 weeks and throughout the 2-year observation period .
-RESULTS	The number of patients having secondary surgery due to persistent or recurrent symptoms was significantly higher in the X-Stop group , odds ratio ( 95 % confidence interval ) = 6.5 ( 1.3-31 .9 ) .
-RESULTS	Complication rate was similar and low , but more severe for MID .
-CONCLUSIONS	Both MID and X-Stop led to significant symptom improvements .
-CONCLUSIONS	There were no significant clinical differences in effect between the methods at any of the follow-up time points .
-CONCLUSIONS	X-Stop had significant higher risk of secondary surgery .
-CONCLUSIONS	Complication was more severe for MID .
-
-###25428762
-BACKGROUND	In clinical practice , nonsteroidal anti-inflammatory drugs ( NSAIDs ) are commonly discontinued after response to biologic therapy is achieved in patients with axial spondyloarthritis ( axSpA ) , but the impact of NSAID discontinuation has not been assessed in prospective controlled trials .
-BACKGROUND	The aim of the SPARSE study was to evaluate the effects of the anti-tumor necrosis factor agent etanercept on NSAID intake and conventional clinical outcomes in axSpA patients .
-METHODS	In the double-blind , placebo-controlled period , patients with active ( mini Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) 4 ) axSpA despite optimal NSAID intake were randomized to receive etanercept 50mg or placebo once weekly for 8weeks .
-METHODS	All patients were advised to taper/discontinue their NSAID intake during the treatment period .
-METHODS	NSAID intake was self-reported by diary and Assessment of SpondyloArthritis International Society ( ASAS ) - NSAID scores calculated based on ASAS recommendations .
-METHODS	The primary endpoint was change from baseline to week 8 in ASAS-NSAID score ( analysis of covariance ) .
-RESULTS	In 90 randomized patients at baseline , mean age ( standard deviation ) was 38.9 ( 11.8 ) years ; disease duration , 5.7 ( 8.1 ) years ; 59/90 ( 66 % ) were human leukocyte antigen-B27 positive ; 51/90 ( 57 % ) had radiographic sacroiliitis ; and 45/90 ( 50 % ) were magnetic resonance imaging sacroiliitis-positive .
-RESULTS	Mean ASAS-NSAID scores were similar between etanercept and placebo groups at baseline ( 98.2 ( 39.0 ) versus 93.0 ( 23.4 ) ) , as were BASDAI ( 6.0 ( 1.7 ) versus 5.9 ( 1.5 ) ) , and Bath Ankylosing Spondylitis Functional Index ( 5.2 ( 2.1 ) versus 5.1 ( 2.2 ) ) .
-RESULTS	Mean changes ( SE ) in ASAS-NSAID score from baseline to week 8 were -63.9 ( 6.1 ) and -36.6 ( 5.9 ) in the etanercept and placebo groups ( between-group difference , -27.3 ; P = 0.002 ) .
-RESULTS	Significantly higher proportions of patients receiving etanercept versus placebo had an ASAS-NSAID score < 10 ( 46 % versus 17 % ; P = 0.008 ) and ASAS-NSAID score of 0 ( 41 % versus 14 % ; P = 0.013 ) at this time point .
-RESULTS	Significantly more patients in the etanercept versus placebo group achieved BASDAI50 ( 39 % versus 18 % ; P = 0.032 ) and ASAS40 ( 44 % versus 21 % ; P = 0.028 ) at week 8 .
-CONCLUSIONS	In patients with axSpA , etanercept was associated with clinically relevant NSAID-sparing effects in addition to significant improvements in conventional clinical outcomes .
-BACKGROUND	ClinicalTrials.gov NCT01298531 .
-BACKGROUND	Registered 16 February 2011 .
-
-###24797294
-OBJECTIVE	Antimicrobial treatment reduces the symptoms of acute otitis media ( AOM ) .
-OBJECTIVE	The effect of antimicrobial treatment on the duration of middle ear effusion ( MEE ) and concomitant hearing impairment is not known .
-OBJECTIVE	To determine whether the antimicrobial treatment of AOM reduces the duration of MEE .
-METHODS	This randomized , double-blind , placebo-controlled trial involved a total of 84 children with AOM between 6 months and 15 years of age .
-METHODS	Participants were recruited from September 14 , 1999 , to January 4 , 2000 ; October 10 , 2005 , to December 16 , 2005 ; and September 22 , 2009 , to June 4 , 2012 , from among children attending an AOM prevention trial and children visiting local outpatient clinics in Oulu , Finland .
-METHODS	Children were randomly allocated to receive either 40 mg/kg of amoxicillin-clavulanate or a placebo mixture per day for 7 days .
-METHODS	The primary outcome measure was the time to the disappearance of MEE as defined by a normal tympanogram finding ( A curve ) from both ears on 2 consecutive measurement days .
-METHODS	Parents performed daily tympanometry at home .
-METHODS	The study physician performed tympanometry and otoscopy at study entry , after 3 and 7 days , and then weekly until both ears were healthy .
-METHODS	The main secondary outcome measures were the time to normal otoscopy findings and the proportion of children without persistent MEE at 14 days and 2 months .
-RESULTS	Middle ear effusion disappeared 2.0 weeks ( 13.7 days ) earlier ( P = .02 ) in the antimicrobial group ( mean time , 2.7 weeks ; 95 % CI , 1.7-3 .7 ) than in the placebo group ( 4.7 weeks ; 95 % CI , 3.6-5 .7 ) .
-RESULTS	Normal otoscopy findings were observed 1.4 weeks sooner in the antimicrobial group than in the placebo group ( P = .02 ) .
-RESULTS	On day 14 , 69 % of children in the antimicrobial group and 38 % in the placebo group had normal tympanometry findings ( number needed to treat , 3.2 ; 95 % CI , 2.0-10 .5 ) .
-RESULTS	On day 60 , 2 children ( 5 % ) in the antimicrobial group and 10 children ( 24 % ) in the placebo group had persistent MEE ( P = .01 ) .
-CONCLUSIONS	Antimicrobial treatment effectively reduced the duration of MEE and possible concomitant hearing impairment in children with AOM .
-CONCLUSIONS	Antimicrobial treatment also reduced the risk for persistent MEE .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01244581 .
-
-###24532523
-OBJECTIVE	Although the analgesic effects of corticosteroids have been well documented , little information is available on periarticular injection ( PI ) containing corticosteroids for early postoperative pain management after total knee arthroplasty ( TKA ) .
-OBJECTIVE	We performed a prospective double-blind randomized trial to evaluate the efficacy and safety of an intraoperative corticosteroid PI in patients undergoing TKA .
-METHODS	Seventy-six consecutive female patients undergoing bilateral staged TKA were randomized to receive steroid or non-steroid PI , with 3 months separating the procedures .
-METHODS	The steroid group received PI with a mixture containing triamcinolone acetonide ( 40 mg ) .
-METHODS	The non-steroid group received the same injection mixture without corticosteroid .
-METHODS	During the postoperative period , nighttime pain , functional recovery [ straight leg raising ( SLR ) ability and maximal flexion ] , patient satisfaction , and complications were recorded .
-METHODS	Short-term postoperative clinical scores and patient satisfaction were evaluated at 6 months .
-RESULTS	The pain level was significantly lower in the PI steroid than the non-steroid group on the night of the operation ( VAS , 1.2 vs. 2.3 ; p = 0.021 ) .
-RESULTS	Rebound pain was observed in both groups at POD1 ( VAS , 3.2 vs. 3.8 ; p = 0.248 ) , but pain remained at a low level thereafter .
-RESULTS	No significant differences were seen in maximal flexion , frequency of acute rescuer , clinical scores , and patient satisfaction .
-RESULTS	The steroid group was able to perform SLR earlier than the non-steroid group ( p = 0.013 ) .
-RESULTS	The incidence of complications was similar between the groups .
-CONCLUSIONS	PI containing a corticosteroid provided an additional pain-relieving effect on the night of the operation .
-CONCLUSIONS	In addition , corticosteroid PI did not increase the perioperative complications of TKA .
-
-###24592578
-OBJECTIVE	Our aim was to characterize articulation proficiency and differences between tumor sites before and after chemoradiotherapy for advanced head and neck cancer with the help of acoustic measures .
-OBJECTIVE	Our further goal was to improve objective speech measures and gain insight into muscle functioning before and after treatment .
-METHODS	In 34 patients with laryngeal or hypopharyngeal , nasal or nasopharyngeal , or oral or oropharyngeal cancer , we acoustically analyzed nasality , vowel space , precision , and strength of articulation in 12 speech sounds ( / a / , / i / , / u / , / p / , / s / , / z / , / 1 / , / t / , / tj / , / k / , / x / , / r / ) before treatment and 10 weeks and 1 year after treatment .
-METHODS	Outcomes were compared between assessment points and between tumor sites .
-RESULTS	Nasality in nonlaryngeal sites was significantly reduced by treatment .
-RESULTS	Most affected in articulation were the oral or oropharyngeal cancer sites , followed by the nasal or nasopharyngeal sites .
-RESULTS	One year after treatment , vowel space had not recovered and consonant articulation had weakened .
-RESULTS	Laryngeal sites were less affected in articulation by tumor or treatment .
-CONCLUSIONS	Analyses of articulatory-acoustic features are a useful instrument for assessing articulation and speech quality objectively .
-CONCLUSIONS	Assessment of a number of sounds representing various articulation manners , places , and tongue shapes revealed patterns of speech deterioration after chemoradiotherapy .
-CONCLUSIONS	The results suggest that patients ' speech could benefit from articulation exercises to address changes in muscle coordination and/or sensitivity and to counteract side effects and `` underexercise '' atrophy .
-
-###25194409
-BACKGROUND	The aim of this study was to assess the effects of pioglitazone on blood glucose control and inflammatory biomarkers in diabetic patients receiving insulin after kidney transplantation .
-METHODS	In a randomized placebo-controlled trial , 62 diabetic kidney transplant patients were followed for 4 months after randomly assigned to placebo and pioglitazone ( 30 mg/d ) groups .
-METHODS	All of the patients continued their insulin therapy irrespective of the group that they were assigned to , in order to evaluate the effects of addition of pioglitazone on blood glucose and inflammation biomarkers including serum C-reactive protein , high-sensitivity C-reactive protein , and interleukin-18 levels , as well as erythrocyte sedimentation rate .
-RESULTS	At baseline , there were no significant differences in laboratory studies between the two groups .
-RESULTS	After 4 months of intervention , along with significant improvement in hemoglobin A1c in the pioglitazone group , daily insulin requirements also decreased and lipid profile improved significantly .
-RESULTS	In addition , erythrocyte sedimentation rate , C-reactive protein , and high-sensitivity C-reactive protein values were significantly lower in the pioglitazone group ( P = .03 , P < .001 , and P = .01 ) .
-RESULTS	Interleukin-18 levels were not significantly different at the end of the study between the two groups , but it had a decreasing trend in the pioglitazone group ( P = .002 ) .
-CONCLUSIONS	Pioglitazone complementing insulin in diabetic kidney transplant patients not only improved glycemic control , evidenced by hemoglobin A1c , and reduced daily insulin requirement , but also decreased inflammatory markers which may have an impact on overall cardiovascular events and mortalities beyond glycemic control .
-
-###24738701
-BACKGROUND	Gut microbiota modifiers may have beneficial effects of non-alcoholic fatty liver disease ( NAFLD ) but randomised controlled trials ( RCT ) are lacking in children .
-OBJECTIVE	To perform a double-blind RCT of VSL # 3 vs. placebo in obese children with biopsy-proven NAFLD .
-METHODS	Of 48 randomised children , 44 ( 22 VSL # 3 and 22 placebo ) completed the study .
-METHODS	The main outcome was the change in fatty liver severity at 4 months as detected by ultrasonography .
-METHODS	Secondary outcomes were the changes in triglycerides , insulin resistance as detected by the homoeostasis model assessment ( HOMA ) , alanine transaminase ( ALT ) , body mass index ( BMI ) , glucagon-like peptide 1 ( GLP-1 ) and activated GLP-1 ( aGLP-1 ) .
-METHODS	Ordinal and linear models with cluster confidence intervals were used to evaluate the efficacy of VSL # 3 vs. placebo at 4 months .
-RESULTS	At baseline , moderate and severe NAFLD were present in 64 % and 36 % of PLA children and in 55 % and 45 % of VSL # 3 children .
-RESULTS	The probability that children supplemented with VSL # 3 had none , light , moderate or severe FL at the end of the study was 21 % , 70 % , 9 % and 0 % respectively with corresponding values of 0 % , 7 % , 76 % and 17 % for the placebo group ( P < 0.001 ) .
-RESULTS	No between-group differences were detected in triglycerides , HOMA and ALT while BMI decreased and GLP-1 and aGLP1 increased in the VSL # 3 group ( P < 0.001 for all comparisons ) .
-CONCLUSIONS	A 4-month supplement of VSL # 3 significantly improves NAFLD in children .
-CONCLUSIONS	The VSL # 3-dependent GLP-1 increase could be responsible for these beneficial effects .
-CONCLUSIONS	Trial identifier : NCT01650025 ( www.clinicaltrial.gov ) .
-
-###24308025
-BACKGROUND	Exposure to electromagnetic fields has been reported to have analgesic and antinociceptive effects in several organisms .
-OBJECTIVE	To test the effect of very low-intensity transcranial magnetic stimulation on symptoms associated with fibromyalgia syndrome .
-METHODS	A double-blinded , placebo-controlled clinical trial was performed in the Sagrado Corazn Hospital , Seville , Spain .
-METHODS	Female fibromyalgia patients ( 22 to 50 years of age ) were randomly assigned to either a stimulation group or a sham group .
-METHODS	The stimulation group ( n = 28 ) was stimulated using 8 Hz pulsed magnetic fields of very low intensity , while the sham group ( n = 26 ) underwent the same protocol without stimulation .
-METHODS	Pressure pain thresholds before and after stimulation were determined using an algometer during the eight consecutive weekly sessions of the trial .
-METHODS	In addition , blood serotonin levels were measured and patients completed questionnaires to monitor symptom evolution .
-RESULTS	A repeated-measures ANOVA indicated statistically significant improvement in the stimulation group compared with the control group with respect to somatosensory pain thresholds , ability to perform daily activities , perceived chronic pain and sleep quality .
-RESULTS	While improvement in pain thresholds was apparent after the first stimulation session , improvement in the other three measures occurred after the sixth week .
-RESULTS	No significant between-group differences were observed in scores of depression , fatigue , severity of headaches or serotonin levels .
-RESULTS	No adverse side effects were reported in any of the patients .
-CONCLUSIONS	Very low-intensity magnetic stimulation may represent a safe and effective treatment for chronic pain and other symptoms associated with fibromyalgia .
-
-###24884779
-BACKGROUND	The increasing prevalence of cardiometabolic disease ( CMD ) in combination with an ageing population is a major public health problem .
-BACKGROUND	Early detection and management of individuals at risk for CMD is required to prevent future health problems with associated costs .
-BACKGROUND	General practice is the optimal health care setting to accomplish this goal .
-BACKGROUND	Prevention programs for identification and treatment of patients with an increased risk for CMD in primary care have been proven feasible .
-BACKGROUND	However , the effectiveness and cost-effectiveness have yet to be demonstrated .
-BACKGROUND	The ` Personalized Prevention Approach for CardioMetabolic Risk ' ( PPA CMR ) is such a prevention program .
-BACKGROUND	The objective of the INTEGRATE study is to investigate the effectiveness and cost-effectiveness of PPA CMR , as well as to establish determinants for participation and compliance .
-METHODS	The INTEGRATE study is designed as a stepped-wedge randomized controlled trial with a waiting list control group .
-METHODS	In approximately 40 general practices , all enlisted patients without CMD aged 45-70 years , are invited to participate in PPA CMR .
-METHODS	After an online risk estimation , patients with a score above risk threshold are invited to the GP for additional measurements , detailed risk profiling and tailored treatment of risk factors through medication and/or lifestyle counseling .
-METHODS	At baseline and after twelve months of follow-up lifestyle , health and work status of all participants are established with online questionnaires .
-METHODS	Additionally after twelve months , we will determine health care utilization , costs of PPA CMR and compliance .
-METHODS	Primary endpoints are the number of newly detected patients with CMD and changes in individual risk factors between the intervention and waiting list control group .
-METHODS	Medical data will be extracted from the GPs ' electronic medical records .
-METHODS	In order to assess factors related to participation , we will send questionnaires to non-participants and assess characteristics of participating practices .
-METHODS	For all participants , additional demographic characteristics will be available through Statistics Netherlands .
-CONCLUSIONS	The INTEGRATE study will provide insight into the effectiveness and cost-effectiveness of PPA CMR as well as determinants for participation and compliance , which represents essential information to guide further large-scale implementation of primary prevention programs for CMD .
-BACKGROUND	NTR4277 , The Netherlands National Trial Register , 26-11-2013 .
-
-###25920944
-OBJECTIVE	To investigate whether different study-to-participant communication methods increase response , increase response from hard-to-engage individuals , and influence participants ' consent decisions .
-METHODS	A randomized controlled trial within the Avon Longitudinal Study of Parents and Children .
-METHODS	Cohort members were invited to re-enroll at age 18 and consent to linkage to their health and administrative records .
-METHODS	Participants were randomized to receive one of eight combinations of three interventions : a prior-notification postcard or no contact , a standard or professionally designed consent pack , and a phone or postal reminder .
-METHODS	The primary outcome was return of the consent form ( `` response '' ) , with consent decision being the secondary outcome .
-RESULTS	Of 1,950 participants , 806 ( 41 % ) responded .
-RESULTS	Response rates were 2.7 % higher ( 95 % confidence interval : -0.06 , 5.5 % ; P = 0.06 ) among those receiving designed packs than among those receiving standard packs and 6.4 % higher ( 2.3 , 10.6 % ; P = 0.002 ) among those receiving phone reminders ( compared with postal reminders ) .
-RESULTS	The prior-notification postcard did not influence response rates [ difference = 0 % ( -2.8 , 2.8 % ; P = 1.0 ) ] , and we found no evidence that the communication method influenced consent decision .
-CONCLUSIONS	This trial provides evidence that communication material design can influence response rates and that phone reminders have superior cost/benefit returns over designed materials .
-CONCLUSIONS	Experimental evaluation of communications strategies and dissemination of findings may benefit cohort studies .
-
-###25741153
-OBJECTIVE	To evaluate the necessity of endoscopic nasobiliary drainage ( ENBD ) catheter placement after clearance of common bile duct ( CBD ) stones .
-METHODS	Patients enrolled in this study were randomly divided into two groups , according to whether or not they received ENBD after the removal of CBD stones .
-METHODS	Group 1 ( ENBD group ) was then subdivided into three groups : G1a patients received an endoscopic papillary balloon dilatation ( EPBD ) , G1b patients received an endoscopic sphincterotomy ( EST ) , and G1c patients received neither .
-METHODS	Group 2 ( non-ENBD group ) patients were also subdivided into three groups ( G2a , G2b , and G2c ) , similar to Group 1 .
-METHODS	The maximum CBD diameter , the time for C-reactive protein ( CRP ) to normalize , levels of serum amylase , total serum bilirubin ( TB ) and alanine aminotransferase ( ALT ) , and postoperative hospitalization duration ( PHD ) were measured .
-RESULTS	A total of 218 patients ( 139 males , 79 females ) , with an average age of 60.110.8 years , were enrolled in this study .
-RESULTS	One hundred and thirteen patients who received ENBD were included in Group 1 , and 105 patients who did not receive ENBD were included in Group 2 .
-RESULTS	The baseline clinical characteristics were similar in both groups .
-RESULTS	There were no significant differences in post-endoscopic retrograde cholangiopancreatography ( ERCP ) - related complications when Groups 1 and 2 were compared .
-RESULTS	Seventy-seven patients underwent EPBD , and 41 received an ENBD tube ( G1a ) and 36 did not ( G2a ) .
-RESULTS	Seventy-three patients underwent EST , and 34 patients received an ENBD tube ( G1b ) and 39 did not ( G2b ) .
-RESULTS	The remaining 68 patients underwent neither EPBD nor EST ; of these patients , 38 received an ENBD tube ( G1c ) and 30 did not ( G2c ) .
-RESULTS	For each of the three pairs of subgroups ( G1a vs G2a , G1b vs G2b , G1c vs G2c ) , there were no significant differences detected in the PHD or the time to normalization of CRP , TB and ALT .
-RESULTS	In the EPBD group , the incidence of post-ERCP pancreatitis , hyperamylasemia and overall patient complications was significantly higher for G2a ( post-ERCP pancreatitis : 6/36 vs 0/41 , P = 0.0217 ; hyperamylasemia : 11/36 vs 4/41 , P = 0.0215 ; overall patient complications : 18/36 vs 7/41 , P = 0.0029 ) .
-CONCLUSIONS	After successful CBD stone clearance , ENBD is only beneficial when an EPBD procedure has been performed .
-
-###24708597
-BACKGROUND	Asthma is the most prevalent chronic disease to complicate pregnancies worldwide , affecting around 12 % of pregnant women in Australia .
-BACKGROUND	Oxidative stress and inflammation manifest during pregnancy ; however asthma in pregnancies further intensifies oxidative stress .
-BACKGROUND	Consumption of antioxidant-rich foods has been shown to be beneficial for asthma control in non-pregnant asthmatic adults .
-BACKGROUND	It has not been investigated whether antioxidant-rich foods can improve the elevated oxidative stress that occurs with asthma in pregnancy , thereby improving asthma control .
-BACKGROUND	The primary aim of this study is to determine whether increased consumption of antioxidant-rich foods for 12 weeks will improve maternal asthma control , compared to standard dietary intake during pregnancy .
-METHODS	A 12 week , parallel randomized controlled trial will be conducted .
-METHODS	One hundred and sixty eight pregnant women with mild , moderate , or severe asthma , currently using inhaled corticosteroids , and with poor diet quality , will be recruited at approximately12 weeks gestation .
-METHODS	Following a 4 week run-in period , women will be randomized to either a 12 week antioxidant intervention ( increased consumption of antioxidant-rich foods ( 5 servings/day vegetables , 2 servings/day fruit , 8 servings/day grains ( mostly wholegrains ) , 3-4 serving/week lean meat ) or standard pregnancy care .
-METHODS	The primary outcome is asthma control score ( decrease of 0.5 , the minimally clinically significant change ) .
-METHODS	Secondary outcomes include plasma antioxidants , markers of oxidative stress , and time to , and number of , exacerbations .
-METHODS	With two-tailed t-tests at 80 % power , a sample size of 52 completions per group is required .
-METHODS	Allowing for a 78 % retention including a 20 % removal of women from the analysis due to non-compliance , we will recruit 168 women .
-CONCLUSIONS	It is expected that this 12 week study will improve asthma control .
-CONCLUSIONS	This is significant because asthma is the most prevalent condition to complicate pregnancies and contributes to poor maternal , neonatal and infant health outcomes .
-CONCLUSIONS	Our research will provide the first evidence to show that , in pregnancy , consumption of antioxidant-rich foods is a key modifier of clinical asthma status .
-CONCLUSIONS	This research is crucial for contributing to the evidence base to inform future guidelines given existing clinical and research gaps .
-BACKGROUND	ACTRN12613000301763 .
-
-###25514079
-OBJECTIVE	This study aimed to compare the clinical and radiographic success of preveneered posterior NuSmile and Kinder Krowns over one year and to assess the level of parental satisfaction with their esthetics .
-METHODS	Three trained operators placed 120 crowns in a split-mouth design with a random allocation for 36 participants ( mean age : 5.8 years ) who received two , four , six , or eight crowns .
-METHODS	Blind assessment of the clinical and radiographic performance of the restorations was performed by four calibrated examiners after one year .
-METHODS	Results were analyzed by Fisher 's exact test and McNemar test .
-METHODS	Examiner reliability was determined by Cohen 's kappa score .
-METHODS	Visual analogue scale ( VAS ) was used to assess the level of parental satisfaction .
-RESULTS	All crowns but one were retained , and the majority ( 83 percent ) had no facing fractures .
-RESULTS	Parental satisfaction was high ( 9.4 / 10 on the VAS ) .
-RESULTS	Primary maxillary first molar crowns had more occlusal facing fractures than their mandibular counterparts ( P = .02 ) .
-RESULTS	Primary mandibular second molar crowns showed more facing fractures than their maxillary counterparts ( P = .008 ) .
-RESULTS	Both types showed no statistical difference in most categories , but Kinder Krowns had more facing fractures ( P < .02 ) .
-CONCLUSIONS	Posterior preveneered crowns have predictable durability at 12 months while offering natural appearance to restored teeth .
-
-###24231400
-OBJECTIVE	To determine whether physical activity may affect cognitive performance in patients with Parkinson 's disease by measuring reaction times in patients participating in the Berlin BIG study .
-METHODS	Randomized controlled trial , rater-blinded .
-METHODS	Ambulatory care .
-METHODS	Patients with mild to moderate Parkinson 's disease ( N = 60 ) were randomly allocated to 3 treatment arms .
-METHODS	Outcome was measured at the termination of training and at follow-up 16 weeks after baseline in 58 patients ( completers ) .
-METHODS	Patients received 16 hours of individual Lee Silverman Voice Treatment-BIG training ( BIG ; duration of treatment , 4wk ) , 16 hours of group training with Nordic Walking ( WALK ; duration of treatment , 8wk ) , or nonsupervised domestic exercise ( HOME ; duration of instruction , 1hr ) .
-METHODS	Cued reaction time ( cRT ) and noncued reaction time ( nRT ) .
-RESULTS	Differences between treatment groups in improvement in reaction times from baseline to intermediate and baseline to follow-up assessments were observed for cRT but not for nRT .
-RESULTS	Pairwise t test comparisons revealed differences in change in cRT at both measurements between BIG and HOME groups ( intermediate : -52 ms ; 95 % confidence interval [ CI ] , -84 / -20 ; P = .002 ; follow-up : 55ms ; CI , -105 / -6 ; P = .030 ) and between WALK and HOME groups ( intermediate : -61 ms ; CI , -120 / -2 ; P = .042 ; follow-up : -78 ms ; CI , -136 / -20 ; P = .010 ) .
-RESULTS	There was no difference between BIG and WALK groups ( intermediate : 9ms ; CI , -49 / 67 ; P = .742 ; follow-up : 23ms ; CI , -27 / 72 ; P = .361 ) .
-CONCLUSIONS	Supervised physical exercise with Lee Silverman Voice Treatment-BIG or Nordic Walking is associated with improvement in cognitive aspects of movement preparation .
-
-###24806623
-BACKGROUND	Curative treatment of upper gastrointestinal tract neoplasms is complex and associated with high morbidity and mortality .
-BACKGROUND	In general , the patients are already malnourished , and early postoperative enteral nutrition is recommended .
-BACKGROUND	However , there is no consensus concerning the best enteral access route in these cases .
-METHODS	A prospective randomized trial was performed from 2008 to 2012 with 59 patients who underwent esophagectomy , total gastrectomy , or pancreaticoduodenectomy .
-METHODS	In all , 4 patients declined to participate , and 13 did not meet the inclusion criteria and were excluded .
-METHODS	Of the 42 included patients , 21 had nasoenteric tubes , and 21 had a jejunostomy .
-RESULTS	The two groups were similar in demographic and clinical aspects .
-RESULTS	The nasoenteric ( NE ) and jejunostomy groups underwent early enteral therapy in 71 and 62 % of cases ( p > 0.05 ) , respectively .
-RESULTS	The median length of enteral therapy use was less in the NE group ( 5.0 vs. 8.5 days ) , but the difference was not statistically significant .
-RESULTS	The NE group required introduction of parenteral therapy more frequently than the jejunostomy group ( p < 0.05 ) .
-RESULTS	Complications related to the enteral route occurred in 38.0 and 28.5 % of patients ( p > 0.05 ) in the NE and jejunostomy groups , respectively .
-RESULTS	In the NE group , there were four losses and four tube obstructions .
-RESULTS	In the jejunostomy group , there were two losses , four obstructions , and two cases of leakage around the tube .
-RESULTS	In the latter group , patients who underwent therapy for a longer time had tubal complications ( p < 0.05 ) and longer intensive care unit and hospital stays ( p < 0.05 ) .
-CONCLUSIONS	The two enteral routes were associated with the same number of complications .
-CONCLUSIONS	However , the presence of a jejunostomy allowed enteral therapy for longer periods , especially in patients with complications , thus avoiding the need for parenteral nutrition .
-
-###25631483
-OBJECTIVE	To assess the efficacy and safety of intravitreal bevacizumab ( IVB ) compared with ranibizumab ( IVR ) in the treatment of macular oedema due to branch retinal vein occlusion ( BRVO ) .
-METHODS	In this prospective , randomised , non-inferiority trial , 75 participants with macular oedema due to BRVO received intravitreal injections of ranibizumab or bevacizumab after 1:1 block randomisation .
-METHODS	The primary outcome measure was the difference in mean changes in best-corrected visual acuity ( BCVA ) at 6months .
-METHODS	Secondary outcome measures included mean change in central retinal thickness ( CRT ) , the proportion of patients improving by > 15 letters and the proportion of patients developing neovascularisation .
-RESULTS	Participants received either IVR ( n = 37 ) or IVB ( n = 38 ) .
-RESULTS	The mean BCVA at baseline was 52.814.4 letters ( 20/80 ) and 56.110.0 letters ( 20/80 ) ( p = 0.24 ) in the ranibizumab and bevacizumab groups , respectively .
-RESULTS	At 6months , the mean gains in BCVA were +18.1 letters ( p < 0.0001 ; 95 % CI , +12.8 to +22.6 ) in the ranibizumab group and +15.6 letters ( p < 0.0001 ; 95 % CI +12.0 to +20.5 ) in the bevacizumab group .
-RESULTS	The difference between the mean visual gains of the treated groups ( bevacizumab-ranibizumab ) was -2.5 letters ( 95 % CI -8.0 to +5.0 ; p = 0.74 ) .
-RESULTS	Mean reductions in CRT at 6months were 177.1122.3 m in the ranibizumab group ( p < 0.0001 ) and 201.7166.2 m in the bevacizumab group ( p < 0.0001 ) , with no significant difference between the two groups ( p = 0.48 ) .
-RESULTS	The mean numbers of ranibizumab and bevacizumab injections were 3.21.5 and 3.01.4 , respectively ( p = 0.55 ) .
-RESULTS	Two serious adverse events occurred in the ranibizumab group and one in the bevacizumab group but both were unrelated to intravitreal injections .
-CONCLUSIONS	This study demonstrated significant gain in visual acuity in eyes with BRVO treated with either bevacizumab or ranibizumab .
-CONCLUSIONS	Pro-re-nata strategy was effective in maintaining the visual gain .
-BACKGROUND	http://www.ctri.nic.in/ CTRI/2012/01 / 003120 .
-
-###25982801
-BACKGROUND	To investigate the ability of the prostate genetic score ( PGS-33 ) , a germ-line biomarker of prostate cancer ( PCa ) risk , to categorize men participating in the Prostate , Lung , Colorectal and Ovarian ( PLCO ) Cancer Screening Trial .
-METHODS	We obtained the genetic data from the Cancer Genetic Markers of Susceptibility ( CGEMS ) , a nested case control study examining germ-line DNA in the screened arm of the PLCO trial .
-METHODS	A PGS-33 was calculated based on their genotype at 33 PCa associated single nucleotide polymorphisms ( SNPs ) .
-METHODS	The primary outcome was the diagnosis of PCa and primary predictor was PGS-33 .
-RESULTS	We identified 2,244 subjects ( no cancer , N = 1017 ) and cases ( N = 1227 ) .
-RESULTS	The PGS-33 ( P < 0.001 ) , prostate specific antigen ( PSA ; P < 0.001 ) , family history of PCa ( < 0.001 ) , abnormal digital rectal exam ( DRE , P < 0.001 ) , and history of ever smoking ( P = 0.037 ) were associated with a PCa diagnosis .
-RESULTS	In multivariable analysis , the log ( PGS-33 ) was associated with PCa diagnosis with an odds ratio of 1.68 ( 95 % CI 1.36-2 .08 , P < 0.001 ) , log ( PSA ) ( OR 8.2 ; 95 % CI 6.75-10 .04 , P < 0.001 ) , and family history of PCa ( OR 2.01 ; 95 % CI 1.26-3 .20 , P = 0.003 ) .
-RESULTS	PGS-33 quartiles noted an increasing rate of PCa detection in addition to PSA : 43.2 % ( Q1 ) , 47.8 % ( Q2 ) , 58.8 % ( Q3 ) , and 69.4 ( Q4 ) ( P < 0.001 ) and improvement in PSA performance ( P < 0.001 ) .
-CONCLUSIONS	Germ-line DNA in the form of the PGS-33 is able to risk stratify men regarding their risk of PCa .
-CONCLUSIONS	The PGS-33 may have implications regarding who may benefit most from PCa screening and possibly add to PSA performance .
-
-###25631224
-BACKGROUND	Community-based health education programs may be helpful in improving health outcomes in patients with chronic illnesses .
-BACKGROUND	This study aimed to evaluate community-based health education strategies in the management of hypertensive patients with low socioeconomic status in Dongguan City , China .
-METHODS	This was a randomized , non-blinded trial involving 360 hypertensive patients enrolled in the community health service centre of Liaobu Town , Dongguan City , China .
-METHODS	Participants were randomized to receive one of the three community-based health education programs over 2 years : self-learning reading ( Group 1 ) , monthly regular didactic lecture ( Group 2 ) , monthly interactive education workshop ( Group 3 ) .
-METHODS	Outcomes included the changes in the proportion of subjects with normalized blood pressure ( BP ) , hypertension-related knowledge score , adherence to antihypertensive treatment , lifestyle , body mass index and serum lipids .
-RESULTS	After the 2-y intervention , the proportion of subjects with normalized BP increased significantly in Group 2 ( from 41.2 % to 63.2 % , p < 0.001 ) , and increased more substantially in Group 3 ( from 40.2 % to 86.3 % , p < 0.001 ) , but did not change significantly in Group 1 .
-RESULTS	Improvements in hypertension-related knowledge score , adherence to regular use of medications , appropriate salt intake and regular physical activity were progressively greater from group 1 to group 2 to group 3 .
-RESULTS	Group 3 had the largest reductions in body mass index and serum LDL cholesterol levels .
-CONCLUSIONS	Interactive education workshops may be the most effective strategy in community-based health promotion education programs for hypertensive patients in improving patients ' knowledge on hypertension and alleviating clinical risk factors for preventing hypertension-related complications .
-
-###24525654
-BACKGROUND	Cocaine dependence is a major public health problem with no available robustly effective pharmacotherapy .
-BACKGROUND	This study 's aim was to determine if treatment with sertraline ( SERT ) or SERT plus gabapentin ( GBP ) improved treatment retention , depressive symptoms , and/or cocaine use .
-METHODS	Depressed cocaine-dependent patients ( N = 99 ) were enrolled in a 12-week , double-blind , randomized , placebo ( PLA ) - controlled , clinical trial and placed in research beds at a residential treatment facility ( Recovery Centers of Arkansas ) .
-METHODS	They were randomized by depressive symptom severity and inducted onto 1 of the following while residing at the Recovery Centers of Arkansas : SERT ( 200 mg/d ) , SERT ( 200 mg/d ) plus GBP ( 1200 mg/d ) , or PLA .
-METHODS	Participants transferred to outpatient treatment at the start of their third week , continued receiving study medications or PLA ( weeks 3-12 ) , and participated in weekly individual cognitive behavioral therapy .
-METHODS	Compliance was facilitated through the use of contingency management procedures .
-METHODS	Supervised urine samples were obtained thrice weekly and self-reported mood weekly .
-METHODS	At the end of 12 weeks , participants were tapered off the study medication over 5 days and referred to a local treatment program .
-RESULTS	Sertraline , but not SERT plus GBP , showed a significantly lower overall percentage of cocaine-positive urine samples compared with that of PLA .
-RESULTS	A significantly greater percentage of participants experienced relapse in the PLA group ( 88.9 % ) compared with that of the SERT group ( 65.2 % ) .
-RESULTS	Hamilton depression ratings decreased significantly over time regardless of the treatment group .
-RESULTS	Retention in treatment did not differ significantly between the treatment groups .
-CONCLUSIONS	Sertraline plus GBP may not be superior to SERT alone in delaying relapse among abstinent cocaine-dependent individuals undergoing cognitive behavioral therapy .
-
-###25654961
-OBJECTIVE	To evaluate and compare the efficacy of platelet-rich fibrin ( PRF ) with enamel matrix derivative ( EMD ; Emdogain ) in the treatment of periodontal intrabony defects in patients with chronic periodontitis , six months after surgery .
-METHODS	Forty-four ( 44 ) intrabony defects in 30 patients ( 15 males ) were randomly allocated into two treatment groups : EMD ( n = 22 ) and PRF ( n = 22 ) .
-METHODS	Measurement of the defects was done using clinical and cone beam computed tomography at baseline and 6 months .
-METHODS	Clinical and radiographic parameters such as probing depth , clinical attachment level , intrabony defect depth and defect angle , were recorded at baseline and 6 months post-operatively .
-METHODS	Within group change was evaluated using the Wilcoxon signed rank test .
-METHODS	Intergroup comparisons were made using the Mann-Whitney U test .
-RESULTS	Postsurgical measurements revealed that there was an equal reduction in probing depth and a greater but statistically non-significant attachment gain for the Emdogain group when compared to the platelet-rich fibrin group .
-RESULTS	The Emdogain group presented with significantly greater percentage defect resolution ( 43.07 % 12.21 ) than did the platelet-rich fibrin group ( 32.41 % 14.61 ) .
-RESULTS	Post-operatively the changes in defect width and defect angle were significant in both groups , but upon intergroup comparison they were found to be statistically non-significantly different .
-CONCLUSIONS	Both Emdogain and platelet-rich fibrin were effective in the regeneration of intrabony defects .
-CONCLUSIONS	Emdogain was significantly superior in terms of percentage defect resolution .
-
-###24602137
-OBJECTIVE	HM30181 is a third generation P-glycoprotein ( P-gp ) inhibitor currently under development .
-OBJECTIVE	The objectives of this study were to evaluate the effects of a single dose of HM30181 on the pharmacodynamics and pharmacokinetics of loperamide , a P-gp substrate , and to compare them with those of quinidine .
-METHODS	Eighteen healthy male subjects were administered loperamide alone ( period 1 ) or with loperamide plus quinidine or HM30181 in period 2 or 3 , respectively .
-METHODS	In period 3 , subjects randomly received one of three HM30181 doses : 15 , 60 or 180mg .
-METHODS	Changes in pupil size , alertness , oxygen saturation and the oral bioavailability of loperamide were assessed in each period .
-METHODS	In addition , the pharmacokinetics of HM30181 were determined .
-RESULTS	Pupil size , alertness and oxygen saturation did not change over time when loperamide alone or loperamide plus HM30181 was administered while HM30181 significantly increased the systemic exposure to loperamide , i.e. the geometric mean ratio ( 90 % confidence interval ) of AUC ( 0 , tlast ) for loperamide with and without HM30181 was 1.48 ( 1.08 , 2.02 ) .
-RESULTS	Co-administered quinidine significantly increased the systemic exposure to loperamide 2.2-fold ( 1.53 , 3.18 ) , which also markedly reduced pupil size , resulting in a decrease of 24.7 mmh in the area under the effect curve of pupil size change from baseline compared with loperamide alone .
-CONCLUSIONS	HM30181 inhibits P-gp mainly in the intestinal endothelium , which can be beneficial because pan-inhibition of P-gp , particularly in the brain , could lead to detrimental adverse events .
-CONCLUSIONS	Further studies are warranted to investigate adequately the dose-exposure relationship of HM30181 , along with its duration of effect .
-
-###24643406
-OBJECTIVE	Most stroke rehabilitation studies have been performed in high-income countries .
-OBJECTIVE	The aim of this study was to identify the main barriers for patient inclusion in a research protocol performed in Brazil .
-METHODS	We evaluated reasons for exclusion of patients in a pilot , randomized , double-blinded clinical trial of stroke rehabilitation .
-METHODS	Descriptive statistical analysis was performed .
-RESULTS	Only 5.6 % of 571 screened patients were included .
-RESULTS	Recurrent stroke was responsible for exclusion of 45.4 % of potentially eligible patients .
-CONCLUSIONS	Recurrent stroke represented a big barrier to enroll patients in the protocol .
-CONCLUSIONS	External validity of rehabilitation trials will benefit from definition of study criteria according to regional characteristics of patients , including rates of recurrent stroke .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT01333579 .
-
-###24825641
-OBJECTIVE	Patients with colorectal cancer with liver metastases undergo hepatic resection with curative intent .
-OBJECTIVE	Positron emission tomography combined with computed tomography ( PET-CT ) could help avoid noncurative surgery by identifying patients with occult metastases .
-OBJECTIVE	To determine the effect of preoperative PET-CT vs no PET-CT ( control ) on the surgical management of patients with resectable metastases and to investigate the effect of PET-CT on survival and the association between the standardized uptake value ( ratio of tissue radioactivity to injected radioactivity adjusted by weight ) and survival .
-METHODS	A randomized trial of patients older than 18 years with colorectal cancer treated by surgery , with resectable metastases based on CT scans of the chest , abdomen , and pelvis within the previous 30 days , and with a clear colonoscopy within the previous 18 months was conducted between 2005 and 2013 , involving 21 surgeons at 9 hospitals in Ontario , Canada , with PET-CT scanners at 5 academic institutions .
-METHODS	Patients were randomized using a 2 to 1 ratio to PET-CT or control .
-METHODS	The primary outcome was a change in surgical management defined as canceled hepatic surgery , more extensive hepatic surgery , or additional organ surgery based on the PET-CT .
-METHODS	Survival was a secondary outcome .
-RESULTS	Of the 263 patients who underwent PET-CT , 21 had a change in surgical management ( 8.0 % ; 95 % CI , 5.0 % -11.9 % ) .
-RESULTS	Specifically , 7 patients ( 2.7 % ) did not undergo laparotomy , 4 ( 1.5 % ) had more extensive hepatic surgery , 9 ( 3.4 % ) had additional organ surgery ( 8 of whom had hepatic resection ) , and the abdominal cavity was opened in 1 patient but hepatic surgery was not performed and the cavity was closed .
-RESULTS	Liver resection was performed in 91 % of patients in the PET-CT group and 92 % of the control group .
-RESULTS	After a median follow-up of 36 months , the estimated mortality rate was 11.13 ( 95 % CI , 8.95-13 .68 ) events/1000 person-months for the PET-CT group and 12.71 ( 95 % CI , 9.40-16 .80 ) events/1000 person-months for the control group .
-RESULTS	Survival did not differ between the 2 groups ( hazard ratio , 0.86 [ 95 % CI , 0.60-1 .21 ] ; P = .38 ) .
-RESULTS	The standardized uptake value was associated with survival ( hazard ratio , 1.11 [ 90 % CI , 1.07-1 .15 ] per unit increase ; P < .001 ) .
-RESULTS	The C statistic for the model including the standardized uptake value was 0.62 ( 95 % CI , 0.56-0 .68 ) and without it was 0.50 ( 95 % CI , 0.44-0 .56 ) .
-RESULTS	The difference in C statistics is 0.12 ( 95 % CI , 0.04-0 .21 ) .
-RESULTS	The low C statistic suggests that the standard uptake value is not a strong predictor of overall survival .
-CONCLUSIONS	Among patients with potentially resectable hepatic metastases of colorectal adenocarcinoma , the use of PET-CT compared with CT alone did not result in frequent change in surgical management .
-CONCLUSIONS	These findings raise questions about the value of PET-CT scans in this setting .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00265356 .
-
-###24603072
-OBJECTIVE	Intravenous recombinant tissue-type plasminogen activator ( r-tPA ) , despite a risk of early symptomatic intracranial hemorrhage ( sICH ) , is of net clinical benefit to acute stroke patients .
-OBJECTIVE	We tested if predictive models could identify patients least likely to be harmed by sICH or those who gained no net benefit .
-METHODS	We used the Third International Stroke Trial ( IST-3 ) trial data set , an international , multicenter , open treatment randomized trial of 0.9 mg/kg r-tPA versus control in 3035 patients with acute ischemic stroke .
-METHODS	We compared the discrimination and calibration of previously developed predictive models for ICH and poststroke poor outcome and developed a new model using variables selected by systematic review .
-METHODS	We calculated the absolute and relative risk reduction of death or dependency with r-tPA in patients at a low , medium , or high predicted risk of sICH or poor functional outcome .
-RESULTS	Prediction models for sICH or poor outcome ( Hemorrhage After Thrombolysis [ HAT ] ; Sugar , Early Infarct Signs , Dense Artery , Age , National Institutes of Health ( NIH ) Stroke Score ( SEDAN ) ; Glucose Race Age Sex Pressure Stroke Severity [ GRASPS ] ; Stroke Thrombolytic Predictive Instrument ; Dense Artery , Rankin Score , Age , Glucose , Onset to Treatment Time , NIHSS [ DRAGON ] ; Totaled Health Risks in Vascular Events [ THRIVE ] ; our new model ; and a model with National Institutes of Health Stroke Scale and age ) had similar area under receiver operator characteristic curves ( AUROCC ) to predict sICH ( P for difference > 0.05 ) .
-RESULTS	The simplest model ( with covariates National Institutes of Health Stroke Scale and age ) predicted both sICH ( AUROCC , 0.63 ; 95 % CI , 0.58-0 .68 ) and poststroke poor functional outcome ( AUROCC , 0.80 ; 95 % CI , 0.77-0 .82 ) similarly to complex models .
-RESULTS	There was no evidence that the effect of r-tPA in patients at high predicted risk of sICH or poor functional outcome after stroke was less than in those at lower risk .
-CONCLUSIONS	There is a clinically relevant net positive effect of r-tPA in patients with acute stroke at a high predicted risk of sICH or poor functional outcome .
-BACKGROUND	http://www.controlled-trials.com .
-BACKGROUND	Unique identifier : ISRCTN25765518 .
-
-###24836474
-BACKGROUND	We sought to determine whether the design of 3 different double-lumen endobronchial tubes ( DLT ) ( Rusch , Mallinckrodt , Fuji ) has an effect on the ease of placement over an airway exchange catheter ( AEC ) using a video laryngoscope .
-METHODS	A convenience sample of 17 anesthesia residents and fellows with at least 3 years of anesthesia training was recruited from teaching hospitals in Toronto for a randomized crossover trial .
-METHODS	Each participant passed each DLT over an AEC in an airway simulator , visualized and video recorded via a video laryngoscope ( GlideScope ) .
-METHODS	The order of exchange was randomized by blindly pulling the name of the manufacturer of a DLT from a box .
-METHODS	The primary outcome was time to intubate , defined as time from the bronchial lumen entering the GlideScope view to the bronchial lumen passing the vocal cords .
-METHODS	Also recorded were participants ' subjective rating of the ease of use and failure rate , defined as an attempt > 150-second duration .
-RESULTS	Time to intubate was faster with the Fuji-Phycon DLT ( median 2 seconds ) compared with both the Rusch ( median 27 seconds , P = 0.0144 ) and Mallinckrodt ( median 21 seconds , P = 0.0117 ) .
-RESULTS	On a scale of 1 to 10 , with 10 being very easy to use and 1 being very difficult , the Fuji-Phycon was judged to be easier to use ( median 10 seconds ) compared with the Rusch ( median 3 , P = 0.0186 ) and the Mallinckrodt ( median 4 seconds , P = 0.0123 ) .
-RESULTS	The Rusch was associated with significantly more failures than the other DLTs , P = 0.002 .
-CONCLUSIONS	The Fuji-Phycon DLT was easier to pass over an AEC in this simulator trial and warrants consideration in patients with difficult airways who require 1-lung ventilation .
-
-###24397879
-OBJECTIVE	Acute kidney injury ( AKI ) after cardiac surgery procedures is associated with poor patient outcomes .
-OBJECTIVE	Cystatin C as a marker for renal failure has been shown to be of prognostic value ; however , a wide range of its predictive accuracy has been reported .
-OBJECTIVE	The aim of the study was to evaluate whether the measurement of pre - and postoperative serum cystatin C improves the prediction of AKI .
-METHODS	In a single-centre , prospective study of 70 patients ( 74 9 ys ; range 47-85 ys ; 77 % male ) , cystatin C was measured six times : ( T1 = preoperative , T2 = start cardiopulmonary bypass ( CPB ) , T3 = 20 min after CPB , T4 = end of operation ; T5 = 24 h postoperatively ; T6 = 7d postoperatively ) .
-METHODS	Predictive property , in terms of the need for renal replacement therapy ( RRT ) , was analysed by receiver operating characteristics ( ROC ) statistics and described by the area under the curve ( AUC ) .
-RESULTS	With respect to RRT ( n = 8 ) , serum cystatin C was significantly higher at the end of the operation ( T4 ) , 24 h postoperatively at T5 and at T6 .
-RESULTS	The AUCs for preoperative T1 and intraoperative T2/3 cystatin C were < 0.7 ( 95 % CI , 0.47-0 .85 ) .
-RESULTS	The earliest significant predictive AUCs were found at the end of the operation ( T4 : p = 0.03 95 % CI 0.58-0 .88 AUC 0.73 ) and 24 h postoperatively ( T5 : p = 0.003 95 % CI 0.74-0 .96 AUC 0.85 ) .
-CONCLUSIONS	Early postoperative serum cystatin C increase appears to be a moderate biomarker in the prediction of AKI , whereas a preoperative and intraoperative cystatin C increase has only a limited diagnostic and predictive value .
-
-###25243647
-OBJECTIVE	To examine whether 12 weeks of treatment with a dipeptidyl peptidase-4 ( DPP-4 ) inhibitor , sitagliptin , influences the insulin secretion induced by glucose , glucose-dependent insulinotropic polypeptide ( GIP ) and glucagon-like peptide-1 ( GLP-1 ) during a hyperglycaemic clamp in patients with type 2 diabetes ( T2DM ) .
-METHODS	A randomized , double-blind , placebo-controlled study was conducted over 12 weeks , during which 25 patients with T2DM completed treatment with either sitagliptin ( 100mg once daily ) or placebo as add-on therapy to metformin [ sitagliptin group ( n = 12 ) : meanstandard error of the mean ( s.e.m. ) age 542.5 years , means.e.m .
-METHODS	HbA1c 7.80.2 % ; placebo group ( n = 13 ) : means.e.m .
-METHODS	age : 573.0 years , means.e.m .
-METHODS	HbA1c 7.90.2 % ] .
-METHODS	In weeks 1 and 12 , the patients underwent three 2-h 15-mM hyperglycaemic clamp experiments with infusion of either saline , GLP-1 or GIP .
-METHODS	- cell function was evaluated according to first-phase , second-phase , incremental and total insulin and C-peptide responses .
-RESULTS	In the sitagliptin group , the mean HbA1c concentration was significantly reduced by 0.9 % ( p = 0.01 ) .
-RESULTS	The total - cell response during GIP infusion improved significantly from week 1 to week 12 , both within the sitagliptin group ( p = 0.004 ) and when compared with the placebo group ( p = 0.04 ) .
-RESULTS	The total - cell response during GLP-1 infusion was significantly higher ( p = 0.001 ) when compared with saline and GIP infusion , but with no improvement from week 1 to week 12 .
-RESULTS	No significant changes in - cell function occurred in the placebo group .
-CONCLUSIONS	Treatment with the DPP-4 inhibitor sitagliptin over 12 weeks in patients with T2DM partially restored the lost insulinotropic effect of GIP , whereas the preserved insulinotropic effect of GLP-1 was not further improved .
-CONCLUSIONS	A gradual enhancement of the insulinotropic effect of GIP , therefore , possibly contributes to the antidiabetic actions of DPP-4 inhibitors .
-
-###25610500
-OBJECTIVE	Fluticasone and formoterol are effective in the treatment of asthma .
-OBJECTIVE	When a corticosteroid alone fails to control asthma , combination therapy is the treatment of choice .
-OBJECTIVE	The objective of this study was to compare the efficacy and safety of formulations containing budesonide/formoterol ( BUD/FOR ) , fluticasone alone ( FLU ) , and the single-capsule combination of fluticasone/formoterol ( FLU/FOR ) on lung function in patients with mild-to-moderate persistent asthma .
-METHODS	This was a randomized , multicenter , open phase III trial conducted in Brazil .
-METHODS	The primary efficacy analysis was the assessment of non-inferiority between FLU/FOR and BUD/FOR combinations regarding FEV1 ( in L ) at the final visit .
-METHODS	The secondary analyses were PEF , level of asthma control , serum cortisol levels , frequency of adverse events , adherence to treatment , and appropriate inhaler use .
-RESULTS	We randomized 243 patients to three groups : FLU/FOR ( n = 79 ) , BUD/FOR ( n = 83 ) , and FLU ( n = 81 ) .
-RESULTS	In terms of the mean FEV1 after 12 weeks of treatment , the difference between the FLU/FOR and BUD/FOR groups was 0.22 L ( 95 % CI : -0.06 to 0.49 ) , whereas the difference between the FLU/FOR and FLU groups was 0.26 L ( 95 % CI : -0.002 to 0.52 ) .
-RESULTS	Non-inferiority was demonstrated by the difference between the lower limits of the two 95 % CIs ( -0.06 vs. -0.002 ) .
-RESULTS	The level of asthma control and PEF were significantly greater in the FLU/FOR and BUD/FOR groups than in the FLU group .
-RESULTS	There were no significant differences among the groups regarding patient adherence , patient inhaler use , or safety profile of the formulations .
-CONCLUSIONS	The single-capsule combination of FLU/FOR showed non-inferiority to the BUD/FOR and FLU formulations regarding efficacy and safety , making it a new treatment option for persistent asthma .
-
-###24692475
-OBJECTIVE	Atrial fibrillation is associated with decline of cognitive function .
-OBJECTIVE	Observational evidence suggests that anticoagulation might protect against this decline .
-OBJECTIVE	We report the first randomized controlled trial evidence on the effect of anticoagulation on cognitive function in elderly patients with atrial fibrillation .
-METHODS	A total of 973 patients aged75 years with atrial fibrillation were recruited from primary care and randomly assigned to warfarin ( n = 488 ; target international normalized ratio , 2-3 ) or aspirin ( n = 485 ; 75 mg/d ) .
-METHODS	Neither participants nor investigators were masked to group assignment .
-METHODS	Follow-up was for a mean of 2.7 years ( SD , 1.2 ) .
-METHODS	Cognitive outcome was assessed using the Mini-Mental State Examination at 9 - , 21 - , and 33-month follow-up .
-METHODS	Participants who had a stroke were censored from the analysis , which was by intention to treat with imputation for missing data .
-RESULTS	There was no difference between mean Mini-Mental State Examination scores in people assigned to warfarin or aspirin at 9 or 21 months .
-RESULTS	At 33-month follow-up , there was a nonsignificant difference of 0.56 in favor of warfarin that decreased to 0.49 ( 95 % confidence interval , -0.01 to 0.98 ) after imputation .
-CONCLUSIONS	We found no evidence that anticoagulation confers clinically important protection over aspirin against cognitive decline as measured by the Mini-Mental State Examination in atrial fibrillation in the first 33 months of treatment other than that provided by preventing clinical stroke .
-BACKGROUND	http://www.controlled-trials.com .
-BACKGROUND	Unique identifier : ISRCTN89345269 .
-
-###24912901
-OBJECTIVE	The aim of this study was to identify the effects of a communication skills training ( CST ) program for oncologists , developed based on patient preferences regarding oncologists ' communication .
-METHODS	Thirty oncologists were randomly assigned to either an intervention group ( IG ; 2-day CST workshop ) or control group ( CG ) .
-METHODS	Participants were assessed on their communication performance during simulated consultation and their confidence in communicating with patients at baseline and follow-up .
-METHODS	A total of 1,192 patients ( response rate , 84.6 % ) who had consultations with the participating oncologists at baseline and/or follow-up were assessed regarding their distress using the Hospital Anxiety and Depression Scale , satisfaction with the consultation , and trust in their oncologist after the consultation .
-RESULTS	At the follow-up survey , the performance scores of the IG had improved significantly , in terms of their emotional support ( P = .011 ) , setting up a supportive environment ( P = .002 ) , and ability to deliver information ( P = .001 ) , compared with those of the CG .
-RESULTS	Oncologists in the IG were rated higher at follow-up than those in the CG in terms of their confidence in themselves ( P = .001 ) .
-RESULTS	Patients who met with oncologists after they had undergone the CST were significantly less depressed than those who met with oncologists in the CG ( P = .027 ) .
-RESULTS	However , the CST program did not affect patient satisfaction with oncologists ' style of communication .
-CONCLUSIONS	A CST program based on patient preferences is effective for both oncologists and patients with cancer .
-CONCLUSIONS	Oncologists should consider CST as an approach to enhancing their communication skills .
-
-###24342386
-OBJECTIVE	Attention bias modification treatment ( ABMT ) is a promising novel treatment for anxiety disorders , but clinical trials have focused largely on stand-alone formats among adults .
-OBJECTIVE	This randomized controlled trial examined the augmenting effects of threat-based ABMT on cognitive behavioral therapy ( CBT ) in clinically anxious youth .
-METHODS	Sixty-three treatment-seeking children with anxiety disorder were randomly assigned to 1 of the following 3 treatment groups : ABMT + CBT ; ABMT placebo + CBT ; and CBT-alone .
-METHODS	Participants in the 2 ABMT conditions received repeated training on dot-probe tasks either designed to shift attention away from threats ( active ) or designed to induce no changes in attention patterns ( placebo ) .
-METHODS	Primary outcome measures were frequency and severity of anxiety symptoms as determined by a clinician using a semi-structured interview .
-METHODS	Self - and parent-rated anxiety measures and threat-related attention bias scores were also measured before and after treatment .
-RESULTS	Both the active and placebo ABMT groups showed greater reductions in clinician-rated anxiety symptoms than the CBT-alone group .
-RESULTS	Furthermore , only the active ABMT group showed significant reduction in self - or parent-rated anxiety symptoms .
-RESULTS	Finally , all groups showed a shift in attention patterns across the study , starting with a bias toward threat at baseline and shifting attention away from threat after treatment .
-CONCLUSIONS	Active and placebo ABMT might augment the clinical response to CBT for anxiety .
-CONCLUSIONS	This effect could arise from benefits associated with performing computer-based paradigms such as the dot-probe task .
-CONCLUSIONS	Given the absence of group differences in attention-bias changes during treatment , possible mechanisms and methodological issues underlying the observed findings are discussed .
-CONCLUSIONS	Clinical trial registration information-Augmenting Effects of ABMT on CBT in Anxious Children : A Randomized Clinical Trial ; http://clinicaltrials.gov/; NCT01730625 .
-
-###25525278
-OBJECTIVE	To analyze the effect of psychological intervention on reducing performance anxiety and the consequences of the intervention on first-year pharmacy students .
-METHODS	In this experimental study , 236 first-year undergraduate pharmacy students from a private university in Malaysia were approached between weeks 5 and 7 of their first semester to participate in the study .
-METHODS	The completed responses for the Westside Test Anxiety Scale ( WTAS ) , the Kessler Perceived Distress Scale ( PDS ) , and the Academic Motivation Scale ( AMS ) were received from 225 students .
-METHODS	Out of 225 students , 42 exhibited moderate to high test anxiety according to the WTAS ( score ranging from 30 to 39 ) and were randomly placed into either an experiment group ( n = 21 ) or a waiting list control group ( n = 21 ) .
-RESULTS	The prevalence of test anxiety among pharmacy students in this study was lower compared to other university students in previous studies .
-RESULTS	The present study 's anxiety management of psychoeducation and systematic education for test anxiety reduced lack of motivation and psychological distress and improved grade point average ( GPA ) .
-CONCLUSIONS	Psychological intervention helped significantly reduce scores of test anxiety , psychological distress , and lack of motivation , and it helped improve students ' GPA .
-
-###25882396
-BACKGROUND	Treatment for patients with chronic lymphocytic leukaemia who are elderly or who have comorbidities is challenging because fludarabine-based chemoimmunotherapies are mostly not suitable .
-BACKGROUND	Chlorambucil remains the standard of care in many countries .
-BACKGROUND	We aimed to investigate whether the addition of ofatumumab to chlorambucil could lead to better clinical outcomes than does treatment with chlorambucil alone , while also being tolerable for patients who have few treatment options .
-METHODS	We carried out a randomised , open-label , phase 3 trial for treatment-naive patients with chronic lymphocytic leukaemia in 109 centres in 16 countries .
-METHODS	We included patients who had active disease needing treatment , but in whom fludarabine-based treatment was not possible .
-METHODS	We randomly assigned patients ( 1:1 ) to receive oral chlorambucil ( 10 mg/m ( 2 ) ) on days 1-7 of a 28 day treatment course or to receive chlorambucil by this schedule plus intravenous ofatumumab ( cycle 1 : 300 mg on day 1 and 1000 mg on day 8 ; subsequent cycles : 1000 mg on day 1 ) for three to 12 cycles .
-METHODS	Assignment was done with a randomisation list that was computer generated at GlaxoSmithKline , and was stratified , in a block size of two , by age , disease stage , and performance status .
-METHODS	The primary endpoint was progression-free survival in the intention-to-treat population and assessment was done by an independent review committee that was masked to group assignment .
-METHODS	The study is registered with ClinicalTrials.gov , number NCT00748189 .
-RESULTS	We enrolled 447 patients , median age 69 years ( range 35-92 ) .
-RESULTS	Between Dec 22 , 2008 , and May 26 , 2011 , we randomly assigned 221 patients to chlorambucil plus ofatumumab and 226 patients to chlorambucil alone .
-RESULTS	Median progression-free survival was 224 months ( 95 % CI 190-252 ) in the group assigned to chlorambucil plus ofatumumab compared with 131 months ( 106-138 ) in the group assigned to chlorambucil only ( hazard ratio 057 , 95 % CI 045-072 ; p < 00001 ) .
-RESULTS	Grade 3 or greater adverse events were more common in the chlorambucil plus ofatumumab group ( 109 [ 50 % ] patients ; vs 98 [ 43 % ] given chlorambucil alone ) , with neutropenia being the most common event ( 56 [ 26 % ] vs 32 [ 14 % ] ) .
-RESULTS	Grade 3 or greater infections had similar frequency in both groups .
-RESULTS	Grade 3 or greater infusion-related adverse events were reported in 22 ( 10 % ) patients given chlorambucil plus ofatumumab .
-RESULTS	Five ( 2 % ) patients died during treatment in each group .
-CONCLUSIONS	Addition of ofatumumab to chlorambucil led to clinically important improvements with a manageable side-effect profile in treatment-naive patients with chronic lymphocytic leukaemia who were elderly or had comorbidities .
-CONCLUSIONS	Chlorambucil plus ofatumumab is therefore an important treatment option for these patients who can not tolerate more intensive therapy .
-BACKGROUND	GlaxoSmithKline , Genmab A/S .
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-###24898304
-OBJECTIVE	To compare the efficacy and safety of weekly albiglutide with daily sitagliptin , daily glimepiride , and placebo .
-METHODS	Patients with type 2 diabetes receiving metformin were randomized to albiglutide ( 30 mg ) , sitagliptin ( 100 mg ) , glimepiride ( 2 mg ) , or placebo .
-METHODS	Blinded dose titration for albiglutide ( to 50 mg ) and glimepiride ( to 4 mg ) was based on predefined hyperglycemia criteria .
-METHODS	The primary end point was change in HbA1c from baseline at week 104 .
-METHODS	Secondary end points included fasting plasma glucose ( FPG ) , weight , and time to hyperglycemic rescue .
-RESULTS	Baseline characteristics were similar among the albiglutide ( n = 302 ) , glimepiride ( n = 307 ) , sitagliptin ( n = 302 ) , and placebo ( n = 101 ) groups .
-RESULTS	Baseline HbA1c was 8.1 % ( 65.0 mmol/mol ) ; mean age was 54.5 years .
-RESULTS	The mean doses for albiglutide and glimepiride at week 104 were 40.5 and 3.1 mg , respectively .
-RESULTS	At week 104 , albiglutide significantly reduced HbA1c compared with placebo ( -0.9 % [ -9.8 mmol/mol ] ; P < 0.0001 ) , sitagliptin ( -0.4 % [ -4.4 mmol/mol ] ; P = 0.0001 ) , and glimepiride ( -0.3 % [ -3.3 mmol/mol ] ; P = 0.0033 ) .
-RESULTS	Outcomes for FPG and HbA1c were similar .
-RESULTS	Weight change from baseline for each were as follows : albiglutide -1.21 kg ( 95 % CI -1.68 to -0.74 ) , placebo -1.00 kg ( 95 % CI -1.81 to -0.20 ) , sitagliptin -0.86 kg ( 95 % CI -1.32 to -0.39 ) , glimepiride 1.17 kg ( 95 % CI 0.70-1 .63 ) .
-RESULTS	The difference between albiglutide and glimepiride was statistically significant ( P < 0.0001 ) .
-RESULTS	Hyperglycemic rescue rate at week 104 was 25.8 % for albiglutide compared with 59.2 % ( P < 0.0001 ) , 36.4 % ( P = 0.0118 ) , and 32.7 % ( P = 0.1504 ) for placebo , sitagliptin , and glimepiride , respectively .
-RESULTS	Rates of serious adverse events in the albiglutide group were similar to comparison groups .
-RESULTS	Diarrhea ( albiglutide 12.9 % , other groups 8.6-10 .9 % ) and nausea ( albiglutide 10.3 % , other groups 6.2-10 .9 % ) were generally the most frequently reported gastrointestinal events .
-CONCLUSIONS	Added to metformin , albiglutide was well tolerated ; produced superior reductions in HbA1c and FPG at week 104 compared with placebo , sitagliptin , and glimepiride ; and resulted in weight loss compared with glimepiride .
-
-###25363127
-BACKGROUND	Despite a favorable clinical experience , little evidence exists for the efficacy of greater occipital nerve block ( GONB ) in migraine treatment .
-BACKGROUND	Considering such a premise , we wished to evaluate the therapeutic efficacy of GONB in patients affected by migraine headaches .
-METHODS	A randomized double-blinded controlled trial was conducted on 48 patients suffering from migraine headaches .
-METHODS	A syringe containing 1.0 mL of lidocaine 2 % , 0.5 mL of either saline ( control group , N = 24 ) or triamcinolone 0.5 mL ( intervention group , N = 24 ) was prepared for each patient .
-METHODS	Patients were assessed prior to the injection , and also 2 weeks , 1 month , and 2 months thereafter for severity and frequency of pain , times to use analgesics and any appeared side effects .
-RESULTS	No significant differences were revealed in pain severity , pain frequency , and analgesics use between the two groups at the four study time points including at baseline , and 2 , 4 , and 8 weeks after the intervention .
-RESULTS	However , in both groups , the indices of pain severity , pain frequency , and analgesics use were significantly reduced at the three time points after the intervention compared with before the intervention .
-CONCLUSIONS	GONB with triamcinolone in combination with lidocaine or normal saline with lidocaine results in reducing pain severity and frequency as well as use of analgesics up to two months after the intervention , however any difference attributed to the drug regimens by assessing of the trend of pain characteristics changes .
-
-###24515619
-OBJECTIVE	The aim of the article was to investigate the effect of ondansetron preloading with crystalloid infusion after spinal anesthesia during cesarean delivery .
-METHODS	A total of 66 parturient women scheduled for elective caesarean sections were randomly assigned to two groups .
-METHODS	Five minutes before spinal anesthesia , Group O patients were injected with 4 mg of ondansetron , while Group S patients were injected with 5 mL physiological saline .
-METHODS	Maternal blood pressure and heart rate were measured at 2 minute intervals for 30 minutes .
-METHODS	After delivery , umbilical cord blood samples were analyzed .
-RESULTS	Maternal hypotension and nausea were significantly lower in ondansetron-treated patients versus placebo ( p = 0.011 vs. 0.004 ) .
-RESULTS	Umbilical venous pH was significantly higher in ondansetron-treated patients ( p = 0.006 ) , while partial pressure of carbon dioxide ( Pco 2 ) was significantly lower ( p = 0.002 ) .
-RESULTS	Decreases in maternal systolic and mean arterial blood pressures were significantly lower in ondansetron-treated patients ( p = 0.008 vs. 0.025 ) , with less requirement for phenylephrine administration compared with controls ( p = 0.029 ) .
-CONCLUSIONS	Ondansetron preloading combined with crystalloid infusion significantly reduced hypotension and nausea , while improving acid-base status , as well as reducing vasoconstrictor use .
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-###25332466
-BACKGROUND	The common bean is a staple crop in many African and Latin American countries and is the focus of biofortification initiatives .
-BACKGROUND	Bean iron concentration has been doubled by selective plant breeding , but the additional iron is reported to be of low bioavailability , most likely due to high phytic acid ( PA ) concentrations .
-OBJECTIVE	The present study evaluated the impact of PA on iron bioavailability from iron-biofortified beans .
-METHODS	Iron absorption , based on erythrocyte incorporation of stable iron isotopes , was measured in 22 Rwandese women who consumed multiple , composite bean meals with potatoes or rice in a crossover design .
-METHODS	Iron absorption from meals containing biofortified beans ( 8.8 mg Fe , 1320 mg PA/100 g ) and control beans ( 5.4 mg Fe , 980 mg PA/100 g ) was measured with beans containing either their native PA concentration or with beans that were 50 % dephytinized or > 95 % dephytinized .
-RESULTS	The iron concentration of the cooked composite meals with biofortified beans was 54 % higher than in the same meals with control beans .
-RESULTS	With native PA concentrations , fractional iron absorption from the control bean meals was 9.2 % , 30 % higher than that from the biofortified bean meals ( P < 0.001 ) .
-RESULTS	The quantity of iron absorbed from the biofortified bean meals ( 406 g ) was 19 % higher ( P < 0.05 ) than that from the control bean meals .
-RESULTS	With 50 % and > 95 % dephytinization , the quantity of iron absorbed from the biofortified bean meals increased to 599 and 746 g , respectively , which was 37 % ( P < 0.005 ) and 51 % ( P < 0.0001 ) higher than from the control bean meals .
-CONCLUSIONS	PA strongly decreases iron bioavailability from iron-biofortified beans , and a high PA concentration is an important impediment to the optimal effectiveness of bean iron biofortification .
-CONCLUSIONS	Plant breeders should focus on lowering the PA concentration of high-iron beans .
-CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01521273 .
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-###24880843
-BACKGROUND	The exact force systems as well as their progressions generated by removable thermoplastic appliances have not been investigated .
-BACKGROUND	Thus , the purposes of this experimental study were to quantify the forces and moments delivered by a single aligner and a series of aligners ( Invisalign ; Align Technology , Santa Clara , Calif ) and to investigate the influence of attachments and power ridges on the force transfer .
-METHODS	We studied 970 aligners of the Invisalign system ( 60 series of aligners ) .
-METHODS	The aligners came from 30 consecutive patients , of which 3 tooth movements ( incisor torque , premolar derotation , molar distalization ) with 20 movements each were analyzed .
-METHODS	The 3 movement groups were subdivided so that 10 movements were supported with an attachment and 10 were not .
-METHODS	The patients ' ClinCheck ( Align Technology , Santa Clara , Calif ) was planned so that the movements to be investigated were performed in isolation in the respective quadrant .
-METHODS	Resin replicas of the patients ' intraoral situation before the start of the investigated movement were taken and mounted in a biomechanical measurement system .
-METHODS	An aligner was put on the model , the force systems were measured , and the calculated movements were experimentally performed until no further forces or moments were generated .
-METHODS	Subsequently , the next aligners were installed , and the measurements were repeated .
-RESULTS	The initial mean moments were about 7.3 Nmm for maxillary incisor torque and about 1.0 N for distalization .
-RESULTS	Significant differences in the generated moments were measured in the premolar derotation group , whether they were supported with an attachment ( 8.8 Nmm ) or not ( 1.2 Nmm ) .
-RESULTS	All measurements showed an exponential force change .
-CONCLUSIONS	Apart from a few maximal initial force systems , the forces and moments generated by aligners of the Invisalign system are within the range of orthodontic forces .
-CONCLUSIONS	The force change is exponential while a patient is wearing removable thermoplastic appliances .
-
-###24937024
-OBJECTIVE	This study aims to evaluate the treatment effects of physical exercise on menopausal symptoms in middle-aged female medical staff experiencing perimenopausal syndrome .
-METHODS	A total of 157 female medical staff aged 40 to 55 years and with a Kupperman index score of 15 points or higher were randomized 1:1 into an intervention group ( n = 78 ) or a control group ( n = 79 ) .
-METHODS	Women in the intervention group were asked to perform aerobic physical exercise ( walking with strides ) three times a week or more , whereas those in the control group continued as normal .
-METHODS	Measurements were taken at baseline and on weeks 4 , 8 , and 12 , with total Kupperman index score , scores on individual elements of the scale , weight , and waist circumference recorded .
-METHODS	In addition , fasting blood glucose , triglycerides , total cholesterol , high-density lipoprotein cholesterol , and low-density lipoprotein cholesterol were recorded at baseline and on week 12 .
-METHODS	The effects of physical exercise therapy on perimenopausal syndrome were evaluated by comparing changes in these parameters between the control group and the intervention group .
-RESULTS	Fifty-four and 57 women completed all three follow-ups in the intervention and control groups , respectively .
-RESULTS	On week 12 , the mean ( SD ) change in total Kupperman index score ( -9.23 [ 6.23 ] ) from baseline to week 12 ; the mean ( SD ) changes in individual scores for paresthesia ( -1.08 [ 1.51 ] ) , insomnia ( -1.00 [ 1.46 ] ) , irritability ( -1.00 [ 1.34 ] ) , joint or muscle pain ( -0.75 [ 0.74 ] ) , fatigue ( -0.56 [ 0.75 ] ) , headache ( -0.54 [ 0.75 ] ) , formication ( -0.38 [ 0.66 ] ) , and sexual life ( -0.62 [ 1.71 ] ) ; and the mean ( SD ) changes in total cholesterol ( -0.76 [ 0.63 ] mmol/L ) and triglycerides ( -0.20 [ 0.50 ] mmol/L ) were significantly higher in the intervention group than in the control group ( P < 0.05 ) .
-RESULTS	In the intervention group , total Kupperman index score , weight , body mass index , waist circumference , triglycerides , and total cholesterol were significantly lower on week 12 compared with baseline ( P < 0.05 ) .
-CONCLUSIONS	Physical exercise can substantially reduce menopausal symptoms and improve blood lipid status and body weight .
-
-###24550202
-BACKGROUND	In-hospital cardiac arrest ( IHCA ) outcomes vary widely between hospitals , even after adjusting for patient characteristics , suggesting variations in practice as a potential etiology .
-BACKGROUND	However , little is known about the standards of IHCA resuscitation practice among US hospitals .
-OBJECTIVE	To describe current US hospital practices with regard to resuscitation care .
-METHODS	A nationally representative mail survey .
-METHODS	A random sample of 1000 hospitals from the American Hospital Association database , stratified into 9 categories by hospital volume tertile and teaching status ( major teaching , minor teaching , and nonteaching ) .
-METHODS	Surveys were addressed to each hospital 's cardiopulmonary resuscitation ( CPR ) committee chair or chief medical/quality officer .
-METHODS	A 27-item questionnaire .
-RESULTS	Responses were received from 439 hospitals with a similar distribution of admission volume and teaching status as the sample population ( P = 0.50 ) .
-RESULTS	Of the 270 ( 66 % ) hospitals with a CPR committee , 23 ( 10 % ) were chaired by a hospitalist .
-RESULTS	High frequency practices included having a rapid response team ( 91 % ) and standardizing defibrillators ( 88 % ) .
-RESULTS	Low frequency practices included therapeutic hypothermia and use of CPR assist technology .
-RESULTS	Other practices such as debriefing ( 34 % ) and simulation training ( 62 % ) were more variable and correlated with the presence of a CPR committee and/or dedicated personnel for resuscitation quality improvement .
-RESULTS	The majority of hospitals ( 79 % ) reported at least 1 barrier to quality improvement , of which the lack of a resuscitation champion and inadequate training were the most common .
-CONCLUSIONS	There is wide variability among hospitals and within practices for resuscitation care in the United States with opportunities for improvement .
-
-###24314123
-BACKGROUND	Medications for respiratory disorders including asthma and chronic obstructive pulmonary disease ( COPD ) are typically delivered to the lung by means of a handheld inhaler .
-BACKGROUND	Patient preference for and ability to use the inhaler may influence their adherence to maintenance therapy , and adherence may affect treatment outcomes .
-BACKGROUND	In this study , patient experience of using a dry powder inhaler ( DPI ) , the ELLIPTA DPI , in clinical trials of a new maintenance therapy for asthma and COPD was investigated .
-BACKGROUND	The ELLIPTA DPI has been designed to contain two separate blister strips from which inhalation powder can be delivered , and to be simple to use with a large , easy-to-read dose counter .
-METHODS	Semi-structured , in-depth , qualitative interviews were carried out 2-4 weeks after patients had completed one of six phase IIIa clinical trials using the ELLIPTA DPI .
-METHODS	Interview participants were asked about their satisfaction with various attributes of the inhaler and their preference for the ELLIPTA DPI relative to currently-prescribed inhalers , and responses were explored using an inductive content analysis approach .
-METHODS	Participants also rated the performance of the inhaler on several criteria , using a subjective 1-10 scale .
-RESULTS	Participants with asthma ( n = 33 ) and COPD ( n = 42 ) reported high levels of satisfaction with the ELLIPTA DPI .
-RESULTS	It was frequently described as straightforward to operate and easy to use by interview participants .
-RESULTS	Ergonomic design , mouthpiece fit , and dose counter visibility and ease of interpretation emerged as frequently cited drivers of preference for the ELLIPTA DPI compared with their current prescribed inhaler .
-RESULTS	Of participants with asthma , 71 % preferred the ELLIPTA DPI to DISKUS and 60 % to metered dose inhalers .
-RESULTS	Of participants with COPD , 86 % preferred the ELLIPTA DPI to DISKUS , 95 % to HandiHaler , and 85 % to metered dose inhalers .
-RESULTS	Overall average performance scores were > 9 ( out of 10 ) in participants with asthma and COPD .
-CONCLUSIONS	The ELLIPTA DPI was associated with high patient satisfaction and was preferred to other inhalers by interview participants with asthma and COPD .
-CONCLUSIONS	The development of an inhaler that is regarded as easy and intuitive to use may have positive implications for adherence to therapy in asthma and COPD .
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-###24359521
-BACKGROUND	Despite the high incidence and the economic impact of the common cold , there are still no effective therapeutic options available .
-BACKGROUND	Although traditional Chinese medicine ( TCM ) is widely used in China to treat the common cold , there is still a lack of high-quality clinical trials .
-BACKGROUND	This article sets forth the protocol for a high-quality trial of a new TCM drug , Baoji Tablets , which is designed to treat the common cold with summer-heat and dampness syndrome ( CCSDS ) .
-BACKGROUND	The trial is evaluating both the efficacy and safety of Baoji Tablets .
-METHODS	This study is designed as a multicenter , phase II , parallel-group , double-blind , double-dummy , randomized and placebo-controlled trial .
-METHODS	A total of 288 patients will be recruited from four centers .
-METHODS	The new tablets group are administered Baoji Tablets 0.9 g and dummy Baoji Pills 3.7 g.
-METHODS	The old pills group are administered dummy Baoji Tablets 0.9 g and Baoji Pills 3.7 g.
-METHODS	The placebo control group are administered dummy Baoji Tablets 0.9 g and dummy Baoji Pills 3.7 g. All drugs are taken three times daily for 3 days .
-METHODS	The primary outcome is the duration of all symptoms .
-METHODS	Secondary outcomes include the duration of primary and secondary symptoms , changes in primary and secondary symptom scores and cumulative symptom score at day 4 , as well as an evaluation of treatment efficacy .
-CONCLUSIONS	This is the first multicenter , double-blind , double-dummy , randomized and placebo-controlled trial designated to treat CCSDS in an adult population from China .
-CONCLUSIONS	It will establish the basis for a scientific and objective assessment of the efficacy and safety of Baoji Tablets for treating CCSDS , and provide evidence for a phase III clinical trial .
-BACKGROUND	This study is registered with the Chinese Clinical Trial Registry .
-BACKGROUND	The registration number is ChiCTR-TRC-13003197 .
-
-###24905305
-BACKGROUND	Diabetes is a chronic disease characterized by elevated blood glucose levels .
-BACKGROUND	The appropriate goals in the management of diabetes include maintaining blood glucose levels as close to the normal range as possible , minimizing the adverse effects of free radicals by enhancing antioxidant defenses .
-BACKGROUND	Supplementation with appropriate vitamins may therefore be of value in the prevention and treatment of diabetes .
-METHODS	A total of 92 patients with diabetic neuropathy were enrolled in this randomized controlled study from the general medicine department of a tertiary care hospital .
-METHODS	Patients were randomized into two groups viz. , usual care ( n = 46 ) and intervention group ( n = 46 ) .
-METHODS	Usual care group patients received pregabalin with oral hypoglycemic agents .
-METHODS	Patients in the intervention group received vitamin-E along with their regular medicines .
-METHODS	Pain intensity and quality of life ( QoL ) of patients were assessed using Neuropathy Pain Score and RAND 36 questionnaire .
-METHODS	Blood samples were analyzed for the levels of random blood sugar level and HbA ( 1c ) at the baseline and on the 12th week .
-RESULTS	Significant ( p < 0.05 ) decrease in the random blood sugar level was observed in intervention group when compared with the usual care group and a significant ( p < 0.01 ) reduction in total pain score , and a significant ( p < 0.05 ) improvement in physical health after 12 week treatment of vitamin-E was observed .
-CONCLUSIONS	The study concluded that vitamin-E is a natural antioxidant and it is found to be effective in reducing pain score in diabetic neuropathy patients .
-CONCLUSIONS	The future studies may be directed towards extended duration of action .
-
-###24411681
-BACKGROUND	Childbirth is an important experience in a woman 's life , and unfavorable birth experiences have been shown to negatively impact postpartum maternal health .
-BACKGROUND	Aim of this study was to evaluate the effects of music therapy on postpartum pain , anxiety level , satisfaction and early pospartum depression rate .
-METHODS	Totally 161 primiparous women were recruited and randomized either music group ( n = 80 ) or a control group ( n = 81 ) .
-METHODS	Women in the music group listened to self-selected music during labor .
-METHODS	Postpartum pain intensity , anxiety level and satisfaction rate were measured using the visual analog scale ( VAS ) , postpartum depression rate was assessed with Edinburg Postpartum Depression Scale ( EPDS ) at postpartum day one and day eight .
-RESULTS	Mothers in the music therapy group had a lower level of postpartum pain and anxiety than the control group and it was statistically significant at all time intervals ( 1 , 4 , 8 , 16 and 24h , p < 0.001 ) .
-RESULTS	A significant difference was observed between the two groups in terms of satisfaction rate ( p < 0.001 ) and postpartum depression rate at postpartum day one and day eight ( p < 0.05 ) .
-CONCLUSIONS	We only measured the effect of music therapy on early postpartum depression rate .
-CONCLUSIONS	Effect of music on late postpartum depression rate should be investigated in future .
-CONCLUSIONS	Using music therapy during labor decreased postpartum anxiety and pain , increased the satisfaction with childbirth and reduced early postpartum depression rate .
-CONCLUSIONS	Music therapy can be clinically recommended as an alternative , safe , easy and enjoyable nonpharmacological method for postpartum well-being .
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-###24606626
-BACKGROUND	Learners can focus on mastery ( i.e. task orientation ) or on learning relative to others ( i.e. ego orientation ) .
-BACKGROUND	Previous research suggests task orientations are optimal for learning , a benefit usually linked to the suggestion that qualitative comments are better for learning than quantitative comparisons ( i.e. grades ) .
-BACKGROUND	Yet , it is not clear if the observed effects are attributable to the feedback orientation ( i.e. task versus ego ) , feedback format ( i.e. comments versus numerical scores ) , or an interaction between the two .
-BACKGROUND	Here , we aimed to clarify the effects of feedback orientation and feedback format during simulation-based training in endotracheal intubation .
-METHODS	Forty-one medical students were randomly assigned to four feedback conditions : Task-oriented Numerical ; Ego-oriented Numerical ; Task-oriented Comment , and Ego-oriented Comment .
-METHODS	Participants performed a total of 20 trials of endotracheal intubation .
-METHODS	Pre-test , post-test and retention test assessments included the use of hand motion analysis and a global rating scale ( GRS ) .
-METHODS	Participants rated feedback credibility , self-assessment and self-confidence using Likert-type scales .
-METHODS	Analyses of variance were used to examine group differences .
-RESULTS	Participants ' performance did not differ significantly on the easiest ( p > 0.2 ) or two complex variations of intubation ( p > 0.3 ) .
-RESULTS	For the moderately difficult variation , analyses of hand motion and GRS data revealed significant group differences at post-test ( p < 0.05 ) , but no differences on the retention test .
-RESULTS	Analysis of participants ' perceptions showed significant interactions whereby the Ego-oriented Numerical group rated feedback credibility ( p < 0.01 ) higher than the Task-oriented Numerical group ; the two Comment groups did not differ .
-RESULTS	Some participants recounted negative experiences with the feedback they received .
-CONCLUSIONS	Medical students responded to feedback in ways that challenge previous education research .
-CONCLUSIONS	Specifically , students preferred and improved more in the short term ( but not at retention ) when receiving Ego-oriented feedback in Numerical form .
-CONCLUSIONS	Although learning retention did not differ significantly across feedback conditions , students ' perceptions of themselves and of the teacher and training environment did differ and the implications for trainees ' future learning must be considered .
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-###26349123
-OBJECTIVE	To evaluate the in situ caries performance and safety of two experimental fluoride dentifrice formulations ( 1450 ppm fluoride ) with and without 2 % isopentane as an excipient , in comparison to a positive control , currently marketed dentifrice ( 1450 ppm fluoride ) and a negative control dentifrice ( 0 ppm fluoride ) .
-METHODS	This was a single-center , examiner-blind , randomized , controlled , four-treatment cross-over study .
-METHODS	During each treatment period , the subject wore a modified mandibular partial denture fitted with two gauze-covered , partially demineralized human enamel specimens , and brushed at home for one timed minute , twice daily , for two weeks .
-METHODS	At the end of each treatment period , the enamel specimens were removed from the dentures for analysis .
-METHODS	During the week between treatment periods , subjects returned to their usual dental hygiene practices for four to five days , received a dental prophylaxis , and used a study-designated non-fluoride dentifrice for two to three days before starting the next treatment .
-METHODS	Treatment effect on enamel specimen remineralization was assessed by surface microhardness ( SMH ) .
-METHODS	Enamel fluoride uptake was assessed using microdrill enamel biopsy .
-RESULTS	All fluoride-containing dentifrices demonstrated significant , superior SMH recovery and levels of fluoride uptake compared to the negative control dentifrice .
-RESULTS	No significant differences were observed for either efficacy variable between the experimental dentifrice formulations and the positive control dentifrice .
-RESULTS	No significant difference was observed between the 2 % isopentane dentifrice and the 0 % isopentane dentifrice for SMH recovery .
-CONCLUSIONS	The addition of 2 % isopentane did not positively or negatively affect fluoride efficacy in this model .
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-###25467848
-BACKGROUND	PBT2 is a metal protein-attenuating compound that might reduce metal-induced aggregation of mutant huntingtin and has prolonged survival in a mouse model of Huntington 's disease .
-BACKGROUND	We aimed to assess the safety , tolerability , and efficacy of PBT2 in patients with Huntington 's disease .
-METHODS	In this 26-week , randomised , double-blind , placebo-controlled trial , adults ( 25 years old ) with early-stage to mid-stage Huntington 's disease were randomly assigned ( 1:1:1 ) by a centralised interactive response system to once daily PBT2 250 mg , PBT2 100 mg , or placebo .
-METHODS	Randomisation was stratified by site with a block size of three .
-METHODS	Participants , carers , the steering committee , site investigators , study staff , and the study sponsor were masked to treatment assignment .
-METHODS	Primary endpoints were safety and tolerability .
-METHODS	The safety population consisted of all participants who were randomly assigned and had at least one dose of study drug .
-METHODS	The principal secondary endpoint was cognition , measured by the change from baseline to week 26 in the main composite Z score of five cognitive tests ( Category Fluency Test , Trail Making Test Part B , Map Search , Symbol Digit Modalities Test , and Stroop Word Reading Test ) and scores on eight individual cognitive tests ( the five aforementioned plus the Trail Making Test Part A , Montreal Cognitive Assessment , and the Speeded Tapping Test ) .
-METHODS	The intention-to-treat population comprised participants who were randomly assigned and had at least one efficacy assessment after administration of study drug .
-METHODS	This trial is registered with ClinicalTrials.gov , NCT01590888 .
-RESULTS	Between April 18 , 2012 , and Dec 14 , 2012 , 109 participants were randomly assigned to PBT2 250 mg ( n = 36 ) , PBT2 100 mg ( n = 38 ) , or placebo ( n = 35 ) at 19 research centres in Australia and the USA .
-RESULTS	32 ( 89 % ) individuals on PBT2 250 mg , 38 ( 100 % ) on PBT2 100 mg , and 34 ( 97 % ) on placebo completed the study .
-RESULTS	Six serious adverse events ( acute coronary syndrome , major depression , pneumonia , suicide attempt , viral infection , and worsening of Huntington 's disease ) occurred in five participants in the PBT2 250 mg group , three ( fall with subdural haematoma , suicide attempt , and hospital admission for stabilisation of Huntington 's disease ) occurred in two participants in the PBT2 100 mg group , and one ( increasing aggression ) occurred in a participant in the placebo group .
-RESULTS	The site investigators deemed all , except the worsening of Huntington 's disease , as unrelated to study drug .
-RESULTS	32 ( 89 % ) participants on PBT2 250 mg , 30 ( 79 % ) on PBT2 100 mg , and 28 ( 80 % ) on placebo had at least one adverse event .
-RESULTS	Compared with placebo , neither PBT2 100 mg ( least-squares mean 002 , 95 % CI -010 to 014 ; p = 0772 ) nor PBT2 250 mg ( 007 , -005 to 020 ; p = 0240 ) significantly improved the main composite cognition Z score between baseline and 26 weeks .
-RESULTS	Compared with placebo , the Trail Making Test Part B score was improved between baseline and 26 weeks in the PBT2 250 mg group ( 1765 s , 065-3465 ; p = 0042 ) but not in the 100 mg group ( 079 s improvement , -1575 to 1732 ; p = 0925 ) ; neither dose significantly improved cognition on the other tests .
-CONCLUSIONS	PBT2 was generally safe and well tolerated in patients with Huntington 's disease .
-CONCLUSIONS	The potential benefit on executive function will need to be confirmed in a larger study .
-BACKGROUND	Prana Biotechnology Limited .
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-###25365717
-METHODS	A retrospective radiographical study .
-OBJECTIVE	To construct a predictive model for pelvic tilt ( PT ) based on the sacrofemoral-pubic ( SFP ) angle in patients with thoracolumbar kyphosis secondary to ankylosing spondylitis ( or AS ) .
-BACKGROUND	PT is a key pelvic parameter in the regulation of spine sagittal alignment that can be used to plan the appropriate osteotomy angle in patients with AS with thoracolumbar kyphosis .
-BACKGROUND	However , it could be difficult to measure PT in patients with femoral heads poorly visualized on lateral radiographs .
-BACKGROUND	Previous studies showed that the SFP angle could be used to evaluate PT in adult patients with scoliosis .
-BACKGROUND	However , this method has not been validated in patients with AS .
-METHODS	A total of 115 patients with AS with thoracolumbar kyphosis were included .
-METHODS	Full-length anteroposterior and lateral spine radiographs were all available , with spinal and pelvic anatomical landmarks clearly identified .
-METHODS	PT , SFP angle , and global kyphosis were measured .
-METHODS	The patients were randomly divided into group A ( n = 65 ) and group B ( n = 50 ) .
-METHODS	In group A , the predictive model for PT was constructed by the results of the linear regression analysis .
-METHODS	In group B , the predictive ability and accuracy of the predictive model were investigated .
-RESULTS	In group A , the Pearson correlation analysis revealed a strong correlation between the SFP angle and PT ( r = 0.852 ; P < 0.001 ) .
-RESULTS	The predictive model for PT was constructed as PT = 72.3-0 .82 ( SFP angle ) .
-RESULTS	In group B , PT was predicted by the model with a mean error of 4.6 ( SD = 4.5 ) with a predictive value of 78 % .
-CONCLUSIONS	PT can be accurately predicted by the SFP angle using the current model : PT = 72.3-0 .82 ( SFP angle ) , when the femur heads are poorly visualized on lateral radiographs in patients with AS with thoracolumbar kyphosis .
-METHODS	4 .
-
-###25407792
-BACKGROUND	In type 2 diabetes , acute hyperglycemia worsens endothelial function and inflammation , while resistance to GLP-1 action occurs .
-BACKGROUND	All these phenomena seem to be related to the generation of oxidative stress .
-BACKGROUND	A Mediterranean diet , supplemented with olive oil , increases plasma antioxidant capacity , suggesting that its implementation can have a favorable effect on the aforementioned phenomena .
-BACKGROUND	In the present study , we test the hypothesis that a Mediterranean diet using olive oil can counteract the effects of acute hyperglycemia and can improve the resistance of the endothelium to GLP-1 action .
-METHODS	Two groups of type 2 diabetic patients , each consisting of twelve subjects , participated in a randomized trial for three months , following a Mediterranean diet using olive oil or a control low-fat diet .
-METHODS	Plasma antioxidant capacity , endothelial function , nitrotyrosine , 8-iso-PGF2a , IL-6 and ICAM-1 levels were evaluated at baseline and at the end of the study .
-METHODS	The effect of GLP-1 during a hyperglycemic clamp , was also studied at baseline and at the end of the study .
-RESULTS	Compared to the control diet , the Mediterranean diet increased plasma antioxidant capacity and improved basal endothelial function , nitrotyrosine , 8-iso-PGF2a , IL-6 and ICAM-1 levels .
-RESULTS	The Mediterranean diet also reduced the negative effects of acute hyperglycemia , induced by a hyperglycemic clamp , on endothelial function , nitrotyrosine , 8-iso-PGF2a , IL-6 and ICAM-1 levels .
-RESULTS	Furthermore , the Mediterranean diet improved the protective action of GLP-1 on endothelial function , nitrotyrosine , 8-iso-PGF2a , IL-6 and ICAM-1 levels , also increasing GLP-1-induced insulin secretion .
-CONCLUSIONS	These data suggest that the Mediterranean diet , using olive oil , prevents the acute hyperglycemia effect on endothelial function , inflammation and oxidative stress , and improves the action of GLP-1 , which may have a favorable effect on the management of type 2 diabetes , particularly for the prevention of cardiovascular disease .
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-###24685956
-OBJECTIVE	To investigate the effect of a 9-month physical activity intervention on cardiorespiratory fitness and adiposity among prepubertal children .
-METHODS	Prepubertal children ( 8 - to 9-year-olds , N = 220 , 103 girls ) were randomly assigned to a 9-month physical activity intervention or a control group .
-METHODS	The intervention provided 70 minutes ( 5 days/week ) of moderate to vigorous physical activity .
-METHODS	Maximum oxygen consumption ( Vo2max percentile ) and dual-energy radiograph absorptiometry measured cardiorespiratory fitness and adiposity , respectively .
-METHODS	Intention-to-treat analysis was performed to assess baseline and follow-up cardiorespiratory fitness , percentage fat mass ( % FM ) , percentage central fat mass ( % CFM ) , and estimated visceral adipose tissue ( VAT ) area .
-RESULTS	The intervention group increased in cardiorespiratory fitness ( 5.4 th percentile ; 95 % confidence interval [ CI ] , 1.8 to 8.9 ) and decreased in % FM ( -0.7 % ; 95 % CI , -1.1 to -0.4 ) and % CFM ( -1.3 % ; 95 % CI , -1.9 to -0.7 ) .
-RESULTS	Reductions in % FM were evident for both nonoverweight ( -0.62 % ; 95 % CI , -1.07 to -0.17 ) and overweight or obese ( -0.86 % ; 95 % CI,-1 .46 to -0.25 ) intervention participants .
-RESULTS	Conversely , the control group displayed no change in cardiorespiratory fitness while exhibiting increases in % FM ( 0.4 % ; 95 % CI , 0.1 to 0.7 ) , % CFM ( 0.6 ; 95 % CI , 0.1 to 1.1 ) , and VAT area ( 3.0 cm ( 2 ) ; 95 % CI , 1.6 to 4.4 ) .
-RESULTS	Nonoverweight control participants increased in % FM ( 0.52 % ; 95 % CI , 0.13 to 0.91 ) , and their overweight and obese counterparts increased in VAT ( 4.76 cm ( 2 ) ; 95 % CI , 1.90 to 7.63 ) .
-CONCLUSIONS	The physical activity intervention improved cardiorespiratory fitness , reduced % FM , and prevented accumulation of % CFM among prepubertal children with varying adiposity levels .
-CONCLUSIONS	These findings provide support for daily physical activity recommendations to prevent excess fat mass accumulation in childhood .
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-###24253615
-BACKGROUND	Applying a direct renin inhibitor ( DRI ) to advanced stage chronic kidney disease ( CKD ) patients is a matter of controversy .
-BACKGROUND	The purpose of this study was to evaluate the effect of the DRI , aliskiren , in patients with therapy-resistant hypertension undergoing hemodialysis ( HD ) .
-METHODS	The study was a prospective , randomized multicenter trial exploring the antihypertensive effect of aliskiren in comparison with amlodipine , a calcium channel blocker , in patients undergoing HD .
-METHODS	A total of 83 participants whose blood pressure ( BP ) had previously been treated with more than one antihypertensive agent and not having achieved the BP goal of < 140/90 mmHg were randomly assigned to either aliskiren 150 mg or amlodipine 5 mg as an add-on therapy .
-RESULTS	A significant decrease in pre-dialysis clinic BP and home BP was found only in the amlodipine group and not in the aliskiren group .
-RESULTS	In contrast , there was a significant decrease in atrial natriuretic peptide ( ANP ) in the aliskiren group but not in the amlodipine group .
-RESULTS	N-terminal pro-B-type natriuretic hormone remained unchanged in both groups .
-RESULTS	Aliskiren significantly reduced angiotensin I and II , plasma renin activity , and increased plasma renin content .
-RESULTS	However , such changes were not observed in the amlodipine group .
-CONCLUSIONS	Amlodipine , not aliskiren , effectively reduces BP in CKD patients with refractory hypertension undergoing HD .
-CONCLUSIONS	Aliskiren suppresses the renin-angiotensin system and reduces ANP .
-CONCLUSIONS	Whether the DRI is beneficial in improving cardiovascular events in patients undergoing HD remains to be elucidated in future studies .
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-###25444961
-OBJECTIVE	We determined the feasibility of a definitive trial comparing the effectiveness of group vs individual urotherapy for children with bladder-bowel dysfunction .
-METHODS	Children 6 to 10 years old with bladder-bowel dysfunction were recruited during the course of 1 year .
-METHODS	Feasibility data on screening , eligibility , recruitment and protocol compliance rates were collected .
-METHODS	Patients with high grade hydronephrosis , vesicoureteral reflux or learning disabilities and those who had previously undergone urotherapy were excluded .
-METHODS	Patients were randomized to 1-hour group urotherapy or 15-minute individual urotherapy .
-METHODS	Symptoms and quality of life were measured using the Vancouver Nonneurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome Questionnaire and the Pediatric Incontinence Questionnaire at baseline and at 3 to 6 months of followup .
-METHODS	Within/between group comparisons were conducted using t-tests .
-RESULTS	Of 455 screened children 79 were eligible and 60 were recruited to participate .
-RESULTS	A total of 24 patients randomized to group urotherapy and 25 randomized to individual urotherapy completed the pilot trial ( 6 undergoing group and 5 undergoing individual urotherapy withdrew from the study ) .
-RESULTS	Symptomology scores between group and individual urotherapy were not different at followup ( mean SD 14.7 7.9 vs 13.4 6.3 , p = 0.54 , 95 % CI -5.4 -2.8 ) .
-RESULTS	Quality of life scores between patients undergoing group and individual urotherapy at baseline differed ( mean SD 21.1 10.8 vs 31.0 14.3 , p < 0.01 , 95 % CI 2.7-7 .3 ) but became similar at followup ( 21.0 14.2 vs 20.1 15.3 , p = 0.84 , 95 % CI -9.4 -7.6 ) .
-RESULTS	Within group analyses demonstrated improvement in symptomology from baseline to followup in patients undergoing group ( mean SD 3.6 7.6 , p = 0.03 , 95 % CI 0.4-6 .8 ) and individual urotherapy ( 6.0 5.4 , p < 0.01 , 95 % CI 3.8-8 .3 ) .
-RESULTS	Within group quality of life analyses revealed improvement in Pediatric Incontinence Questionnaire scores from baseline to followup in patients undergoing individual urotherapy ( p < 0.01 , 95 % CI 5.0-16 .9 ) only .
-CONCLUSIONS	Urotherapy , regardless of modality , effectively improved bladder-bowel dysfunction symptoms .
-CONCLUSIONS	A definitive randomized controlled trial is feasible , considering that a high recruitment rate ( 76 % ) for this population has been established .
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-###24412265
-OBJECTIVE	To describe changes in and predictors of comfortable gait speed ( GS-C ) after using a foot-drop stimulator ( FDS ; Bioness L300 ; Bioness Inc , Valencia , CA ) for 42 weeks in persons who had sustained a stroke .
-METHODS	Secondary analysis of prospective assessments .
-METHODS	Multicenter clinical trial .
-METHODS	A total of 99 subjects who had sustained a stroke 3 months earlier and who had GS-C 0.8 m/s and drop foot with a mean age of 60.7 years and a poststroke time of 4.8 years .
-METHODS	GS-C was assessed at baseline and at 30 weeks with and without use of an FDS ( therapeutic effect ) and at 6 , 12 , 30 , 36 , and 42 weeks with use of an FDS ( total effect ) .
-METHODS	After subjects participated in 8 physical therapy sessions , an FDS was used for ambulation over the course of 42 weeks .
-METHODS	Changes in mean GS-C over time , FDS `` responder '' status defined as either 0.1 m/s gain in GS-C ( the minimal clinically important difference [ MCID ] ) or advancing by one Perry Ambulation Category ( PAC ) , and the incidence and nature of adverse events ( AEs ) .
-RESULTS	A total of 74 ( 75 % ) and 69 ( 70 % ) of 99 subjects completed assessments at 30 weeks and 42 weeks , respectively .
-RESULTS	Baseline GS-C was 0.42 m/s without use of an FDS and 0.49 m/s with use of an FDS .
-RESULTS	GS-C improved to 0.54 m/s at 30 weeks without use of an FDS ( effect size = 0.75 ) and 0.54 , 0.55 , 0.58 , 0.60 , and 0.61 m/s at 6 , 12 , 30 , 36 , and 42 weeks with use of an FDS , respectively ( effect size 0.84 at 42 weeks ) .
-RESULTS	Half of the subjects achieved a maximum GS-C by 12 weeks .
-RESULTS	Approximately 18 % were PAC responders and 29 % were MCID responders for 30-week therapeutic effect , and 55 % were PAC responders and 67 % were MCID responders for 42-week total effect .
-RESULTS	After logistic regression , the following factors emerged as the strongest predictors of FDS responders : younger age , faster baseline GS-C and Timed Up and Go , and balance .
-RESULTS	At 42 weeks , 60 % reported a device-related AE ; 92 % were mild and 96 % were anticipated .
-CONCLUSIONS	When an FDS was used , GS-C improved progressively over 42 weeks , with 50 % of patients achieving a clinically meaningful 42-week total effect and 50 % achieving a maximum GS-C by 12 weeks .
-CONCLUSIONS	Younger patients with greater mobility levels may benefit most from use of an FDS .
-CONCLUSIONS	AEs were frequent , mild , and reversible .
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-###24407163
-BACKGROUND	One of the advantages of Internet-based research is the ability to efficiently recruit large , diverse samples of international participants .
-BACKGROUND	Currently , there is a dearth of information on the behind-the-scenes process to setting up successful online recruitment tools .
-OBJECTIVE	The objective of the study was to examine the comparative impact of Spanish - and English-language keywords for a Google AdWords campaign to recruit pregnant women to an Internet intervention and to describe the characteristics of those who enrolled in the trial .
-METHODS	Spanish - and English-language Google AdWords campaigns were created to advertise and recruit pregnant women to a Web-based randomized controlled trial for the prevention of postpartum depression , the Mothers and Babies/Mams y Bebs Internet Project .
-METHODS	Search engine users who clicked on the ads in response to keyword queries ( eg , pregnancy , depression and pregnancy ) were directed to the fully automated study website .
-METHODS	Data on the performance of keywords associated with each Google ad reflect Web user queries from February 2009 to June 2012 .
-METHODS	Demographic information , self-reported depression symptom scores , major depressive episode status , and Internet use data were collected from enrolled participants before randomization in the intervention study .
-RESULTS	The Google ads received high exposure ( 12,983,196 impressions ) and interest ( 176,295 clicks ) from a global sample of Web users ; 6745 pregnant women consented to participate and 2575 completed enrollment in the intervention study .
-RESULTS	Keywords that were descriptive of pregnancy and distress or pregnancy and health resulted in higher consent and enrollment rates ( i.e. , high-performing ads ) .
-RESULTS	In both languages , broad keywords ( eg , pregnancy ) had the highest exposure , more consented participants , and greatest cost per consent ( up to US $ 25.77 per consent ) .
-RESULTS	The online ads recruited a predominantly Spanish-speaking sample from Latin America of Mestizo racial identity .
-RESULTS	The English-speaking sample was also diverse with most participants residing in regions of Asia and Africa .
-RESULTS	Spanish-speaking participants were significantly more likely to be of Latino ethnic background , not married , completed fewer years of formal education , and were more likely to have accessed the Internet for depression information ( P < .001 ) .
-CONCLUSIONS	The Internet is an effective method for reaching an international sample of pregnant women interested in online interventions to manage changes in their mood during the perinatal period .
-CONCLUSIONS	To increase efficiency , Internet advertisements need to be monitored and tailored to reflect the target population 's conceptualization of health issues being studied .
-BACKGROUND	ClinicalTrials.gov NCT00816725 ; http://clinicaltrials.gov/show/NCT00816725 ( Archived by WebCite at http://www.webcitation.org/6LumonjZP ) .
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-###25307976
-BACKGROUND	Excessive systemic inflammatory response remains as a major problem underlying severe burns .
-BACKGROUND	This study aimed to assess the effect of low-dose glucocorticoid treatment in downregulating systemic inflammation in severely burned patients .
-METHODS	A prospective study from 2001 to 2014 at our hospital was conducted to compare the patients who received low-dose glucocorticoid during the acute phase with those who did not .
-METHODS	Patients with burns 70 % or greater of their total body surface area were included , and their plasma levels of inflammatory cytokines and clinical outcomes were compared .
-RESULTS	A total of 69 patients were included in this study , with 31 patients receiving glucocorticoid treatment and the others not .
-RESULTS	Patient demographics including age , burn size , and incidence of inhalation injury were similar in both groups .
-RESULTS	The incidence of pulmonary infection and stress ulcer ( and/or hemorrhage ) was 24.2 % and 3.0 % in the treatment group , respectively , significantly lower than 47.8 % and 19.6 % of the control group ( P < .05 ) .
-RESULTS	Length of hospital stay was almost 13 days shorter in the treatment group ( P < .05 ) , whereas there was no significant difference in the overall mortality , duration of mechanical ventilation , and incidence of sepsis between the 2 groups .
-RESULTS	The enzyme-linked immunosorbent assay results confirmed that the plasma levels of C-reactive protein , tumor necrosis factor - , interleukin-6 , and interleukin-8 were significantly lower in the treatment group ( P < .05 ) .
-CONCLUSIONS	Low dose of glucocorticoid treatment during the acute phase could reduce the levels of proinflammatory cytokines in severely burned patients and subsequently decrease the incidence of pulmonary infection and stress ulcer , as well as the length of hospital stay .
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-###24550580
-OBJECTIVE	To compare the effectiveness and safety of add on therapy of bromocriptine with metformin in type 2 diabetes mellitus ( DM ) patients .
-METHODS	Adult type 2 DM patients fulfilling the inclusion criteria were randomized in three groups .
-METHODS	Group A received metformin ( 1000 mg / day ) , while group B patients were treated with metformin ( 1000 mg/day ) plus bromocriptine ( 0.8 mg/day ) and group C received metformin ( 1000 mg/day ) plus bromocriptine ( 1.6 mg/day ) for 12 weeks .
-METHODS	Fasting plasma glucose ( FPG ) , postprandial plasma glucose ( PPPG ) , and body weight were measured at week 4 , 8 , and 12 visits and glycosylated hemoglobin ( HbA ( 1C ) ) at week 12 visit .
-RESULTS	Metformin alone and in combination with bromocriptine in escalating dose ( 0.8 mg/day and 1.6 mg/day ) significantly ( P < 0.05 ) decreased FPG and PPPG levels at weeks 4 , 8 , and 12 compared with pretreatment values .
-RESULTS	HbA ( 1C ) level in all three treatment groups significantly ( P < 0.05 ) decreased at week 12 as compared with pretreatment baseline value .
-RESULTS	HbA1C level in groups B and C significantly ( P < 0.05 ) decreased as compared with group A at week 12 .
-RESULTS	Addition of bromocriptine to metformin also significantly ( P < 0.05 ) decreased FPG and PPPG levels in a dose-dependent manner as compared with metformin alone .
-RESULTS	Intergroup analysis did not show any statistically significant change in weight of study subjects at different intervals .
-CONCLUSIONS	The combination of bromocriptine with metformin significantly decreased FPG , PPPG , and HbA1C compared with metformin alone in type 2 DM patients in a dose-dependent manner .
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-###24529671
-OBJECTIVE	Nowadays , conventional analgesic agents , which are widely used for pain relief after cesarean section , provide suboptimal analgesia with occasional serious side effects .
-OBJECTIVE	We designed a randomized , double-blind , placebo-controlled study to evaluate the analgesic efficacy of intrathecal ketamine added to bupivacaine after cesarean section .
-METHODS	Sixty patients scheduled for cesarean section under spinal anesthesia were randomly allocated to one of the two groups to receive either bupivacaine 10 mg combined with 0.1 mg/kg ketamine , or bupivacaine 10 mg combined with 0.5 mL distilled water intrathecally .
-METHODS	The time to the first analgesic request , analgesic requirement in the first 24 hours after surgery , onset times of sensory and motor blockades , the durations of sensory and motor blockades , and the incidences of adverse effects such as hypotension , ephedrine requirement , bradycardia , and hypoxemia , were recorded .
-RESULTS	Patients who received ketamine had a significantly prolonged duration of anesthesia compared with those who did not in the control group [ 95 % confidence intervals ( CI ) 195-217 ; p = 0.001 ] .
-RESULTS	The mean time to the first analgesic request was also significantly longer in ketamine group ( 95 % CI 252.5-275 ; p < 0.001 ) .
-RESULTS	The total analgesic consumption in the 24 hours following surgery significantly lessened in the ketamine group compared with that of the control group ( 95 % CI 2-2 .5 ; p < 0.001 ) .
-RESULTS	The two groups did not differ significantly in intraoperative and postoperative side effects .
-CONCLUSIONS	Intrathecal ketamine 0.1 mg/kg co-administered with spinal bupivacaine elongated the time to the first analgesic request and lessened the total analgesic consumption in the first 24 postoperative hours in comparison with bupivacaine alone in the control group following elective cesarean delivery .
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-###25349316
-OBJECTIVE	To measure the effects of participating in structured oral presentation evaluation sessions early in pediatric clerkships on students ' subsequent presentations .
-METHODS	We conducted a single-blind , 3-arm , cluster randomized controlled trial during pediatric clerkships at Boston University School of Medicine , University of Maryland School of Medicine , Oregon Health & Science University , and Case Western Reserve University School of Medicine .
-METHODS	Blocks of students at each school were randomly assigned to experience either ( 1 ) no formal presentation feedback ( control ) or a small-group presentation feedback session early in pediatric clerkships in which students gave live presentations and received feedback from faculty who rated their presentations by using a ( 2 ) single-item ( simple ) or ( 3 ) 18-item ( detailed ) evaluation form .
-METHODS	At the clerkship end , overall quality of subjects ' presentations was rated by faculty blinded to randomization status , and subjects reported whether their presentations had improved .
-METHODS	Analyses included multivariable linear and logistic regressions clustered on clerkship block that controlled for medical school .
-RESULTS	A total of 476 participants were evenly divided into the 3 arms , which had similar characteristics .
-RESULTS	Compared with controls , presentation quality was significantly associated with participating in detailed ( coefficient : 0.38 ; 95 % confidence interval [ CI ] : 0.07-0 .69 ) but not simple ( coefficient : 0.16 ; 95 % CI : -0.12 -0.43 ) feedback sessions .
-RESULTS	Similarly , student self-report of presentation improvement was significantly associated with participating in detailed ( odds ratio : 2.16 ; 95 % CI : 1.11-4 .18 ] but not simple ( odds ratio : 1.89 ; 95 % CI : 0.91-3 .93 ) feedback sessions .
-CONCLUSIONS	Small-group presentation feedback sessions led by faculty using a detailed evaluation form resulted in clerkship students delivering oral presentations of higher quality compared with controls .
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-###24712684
-BACKGROUND	Stroke is a major cause of death and disability in the world , and the prevalence of stroke tends to increase with age .
-BACKGROUND	Despite advances in acute care and secondary preventive strategies , primary prevention should play the most significant role in the reduction of the burden of stroke .
-BACKGROUND	As an important component of traditional Chinese Qigong , Baduanjin exercise is a simple , safe exercise , especially suitable for older adults .
-BACKGROUND	However , current evidence is insufficient to inform the use of Baduanjin exercise in the prevention of stroke.The aim of this trail is to systematically evaluate the prevention effect of Baduanjin exercise on ischemic stroke in the community elder population with high risk factors .
-METHODS	A total of 170 eligible participants from the community elder population will be randomly allocated into the Baduanjin exercise group and usual physical activity control group in a 1:1 ratio .
-METHODS	Besides usual physical activity , participants in the Baduanjin exercise group will accept a 12-week Baduanjin exercise training with a frequency of five days a week and 40 minutes a day .
-METHODS	Primary and secondary outcomes will be measured at baseline , 13 weeks ( at end of intervention ) and 25 weeks ( after additional 12-week follow-up period ) .
-CONCLUSIONS	This study will be the randomized trial to evaluate the effectiveness of Baduanjin exercise for primary prevention of stroke in community elder population with high risk factors of stroke .
-CONCLUSIONS	The results of this trial will help to establish the optimal approach for primary prevention of stroke .
-BACKGROUND	Chinese Clinical Trial Registry : ChiCTR-TRC-13003588 .
-BACKGROUND	Registration date : 24 July , 2013 .
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-###25395354
-BACKGROUND	Oak moss absolute , an extract from the lichen Evernia prunastri , is a valued perfume ingredient but contains extreme allergens .
-OBJECTIVE	To compare the elicitation properties of two preparations of oak moss absolute : ` classic oak moss ' , the historically used preparation , and ` new oak moss ' , with reduced contents of the major allergens atranol and chloroatranol .
-METHODS	The two preparations were compared in randomized double-blinded repeated open application tests and serial dilution patch tests in 30 oak moss-sensitive volunteers and 30 non-allergic control subjects .
-RESULTS	In both test models , new oak moss elicited significantly less allergic contact dermatitis in oak moss-sensitive subjects than classic oak moss .
-RESULTS	The control subjects did not react to either of the preparations .
-CONCLUSIONS	New oak moss is still a fragrance allergen , but elicits less allergic contact dermatitis in previously oak moss-sensitized individuals , suggesting that new oak moss is less allergenic to non-sensitized individuals .
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-###24239202
-OBJECTIVE	This study sought to evaluate the long-term safety and efficacy of everolimus-eluting stents ( EES ) and paclitaxel-eluting stents ( PES ) in patients with obstructive coronary artery disease .
-BACKGROUND	The use of EES compared to PES has been shown to result in improved clinical outcomes in patients undergoing PCI .
-BACKGROUND	However , there have been concerns regarding the durability of these benefits over longer-term follow-up .
-METHODS	SPIRIT III was a prospective , multicenter trial in which 1,002 patients were randomized 2:1 to EES versus PES .
-METHODS	Endpoints included ischemia-driven target vessel failure ( TVF ) ( death , myocardial infarction ( MI ) , or ischemia-driven target vessel revascularization [ TVR ] ) , the pre-specified primary endpoint ) , target lesion failure ( TLF ) ( cardiac death , target-vessel MI , or ischemia-driven target lesion revascularization [ TLR ] ) , major adverse cardiac events ( MACE ) ( cardiac death , MI , or ischemia-driven TLR ) , their individual components and stent thrombosis .
-RESULTS	Five-year follow-up was available in 91.9 % of patients .
-RESULTS	Treatment with EES versus PES resulted in lower 5-year Kaplan-Meier rates of TVF ( 19.3 % vs. 24.5 % , p = 0.05 ) , TLF ( 12.7 % vs. 19.0 % , p = 0.008 ) , and MACE ( 13.2 % vs. 20.7 % , p = 0.007 ) .
-RESULTS	EES also resulted in reduced rates of all-cause death ( 5.9 % vs. 10.1 % , p = 0.02 ) , with nonsignificantly different rates of MI , stent thrombosis , and TLR , and no evidence of late catch-up of TLR over time .
-CONCLUSIONS	At 5 years after treatment , EES compared to PES resulted in durable benefits in composite safety and efficacy measures as well as all-cause mortality .
-CONCLUSIONS	Additionally , the absolute difference in TLR between devices remained stable over time without deterioration of effect during late follow-up .
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-###24439655
-BACKGROUND	Neuropeptide S Receptor ( NPSR1 ) gene has been associated with multiple allergic phenotypes in several patient populations .
-OBJECTIVE	We analysed the effect of the NPSR1 genotypes in the development of asthma , rhinitis , eczema , or food allergy in children randomly receiving either probiotic or placebo treatment .
-METHODS	796 children born to families at high risk for allergic diseases were examined by a paediatrician at the age of three months , six months , two years , and five years .
-METHODS	Asthma , rhinitis , eczema , and food allergy were diagnosed according to international guidelines .
-METHODS	Treatment with probiotics ( double-blinded and placebo controlled ) was begun with mothers at 35 weeks of gestation age and continued after the birth of infants up to the age of six months .
-METHODS	Association and additive inheritance models were used in genetic analyses .
-RESULTS	Distribution of the hopo546333 was suggestive in the group of patients with atopic eczema at two years .
-RESULTS	The hopo546333_G was found more often in those with eczema in the placebo group ( p = 0.048 , after Bonferroni correction ) and the hopo546333_A was found more often in those with eczema and probiotics compared to those with eczema and placebo treatment .
-RESULTS	None of the NPSR1 tagging SNPs was associated with asthma , IgE-mediated asthma , or sensitisation .
-RESULTS	Allergic disease in both parents doubled the risk for IgE-mediated allergic disease ( OR 2.1 ) .
-CONCLUSIONS	The NPSR1 gene SNP hopo546333 showed a suggestive association for high IgE-associated atopic eczema at two years .
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-###25471907
-BACKGROUND	Abundant literature regarding the use of intravenous tranexamic acid ( TXA ) in primary total knee replacement is available .
-BACKGROUND	Randomized controlled trials have confirmed the efficacy of topical TXA compared with placebo , but the comparison between topical and intravenous TXA is unclear .
-BACKGROUND	The present study was designed to verify noninferior efficacy and safety of topical intra-articular TXA compared with intravenous TXA in primary total knee replacement with cemented implants .
-METHODS	A Phase-III , single-center , double-blind , randomized , controlled clinical trial was performed to compare topical intra-articular TXA ( 3 g of TXA in 100 mL of physiological saline solution ) with two intravenous doses of TXA ( 15 mg/kg in 100 mL of physiological saline solution , one dose before tourniquet release and another three hours after surgery ) in a multimodal protocol for blood loss prevention .
-METHODS	The primary outcome was the blood transfusion rate , and the secondary outcomes included visible blood loss ( as measured in the drain ) at twenty-four hours postoperatively and invisible blood loss ( as estimated from the Nadler formula ) at forty-eight hours postoperatively .
-METHODS	The sample size of seventy-eight patients was calculated to give a statistical power of 99 % for demonstrating noninferiority .
-METHODS	Thirty-nine patients each were allocated to receive topical intra-articular TXA ( the experimental group ) and intravenous TXA ( the control group ) ; there were no significant differences in demographics or preoperative laboratory values between the groups .
-METHODS	Noninferiority was estimated by comparing the confidence intervals with a delta of 10 % .
-METHODS	Student t and Mann-Whitney tests were used to assess the significance of any differences .
-RESULTS	The transfusion rate was zero in both groups ; thus , noninferiority was demonstrated for the primary efficacy end point , suggesting equivalence .
-RESULTS	Noninferiority was also demonstrated for the secondary efficacy end points .
-RESULTS	Drain blood loss at twenty-four hours was 315.6 mL ( 95 % confidence interval [ CI ] , 248.5 to 382.7 mL ) in the experimental group and 308.1 mL ( 95 % CI , 247.6 to 368.5 mL ) in the control group ( p = 0.948 , Mann-Whitney ) .
-RESULTS	Also , estimated blood loss at forty-eight hours was 1259.0 mL ( 95 % CI , 1115.6 to 1402.3 mL ) in the experimental group and 1317.9 mL ( 95 % CI , 1175.4 to 1460.4 mL ) in the control group ( p = 0.837 , Mann-Whitney ) .
-RESULTS	No significant safety differences were seen between groups .
-CONCLUSIONS	Topical administration of TXA according to the described protocol demonstrated noninferiority compared with intravenous TXA , with no safety concerns .
-CONCLUSIONS	This randomized controlled trial supports the topical intra-articular administration of TXA in primary total knee replacement with cemented implants .
-METHODS	Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .
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-###26385950
-BACKGROUND	Nutritional anemia is a public health problem among Ghanaian schoolchildren .
-BACKGROUND	There is need to employ dietary modification strategies to solve this problem through school and household feeding programs .
-OBJECTIVE	To evaluate the effectiveness of cowpea-based food containing fish meal served with vitamin C-rich drink to improve iron stores and hemoglobin concentrations in Ghanaian schoolchildren .
-METHODS	The study involved cross-sectional baseline and nutrition intervention phases .
-METHODS	There were 150 participants of age 6 to 12 years .
-METHODS	They were randomly assigned to 3 groups , fish meal - vitamin C ( n = 50 ) , vitamin C ( n = 50 ) , and control ( n = 50 ) , and given different cowpea-based diets for a 6-month period .
-METHODS	Height and weight measurements were done according to the standard procedures , dietary data were obtained by 24-hour recall and food frequency questionnaire , hemoglobin concentrations were determined by Hemocue Hemoglobinometer , and serum ferritin and complement-reactive protein ( CRP ) were determined by enzyme-linked immunosorbent assay .
-METHODS	Participants ' blood samples were examined for malaria parasitemia and stools for helminthes using Giemsa stain and Kato-Katz techniques , respectively .
-RESULTS	Mean ferritin concentration was not significantly different among groups .
-RESULTS	End line mean or change in hemoglobin concentrations between fish meal-vitamin C group ( 128.4 7.2 / 8.3 10.6 g/L ) and control ( 123.1 6.6 / 4.2 10.4 g/L ) were different , P < .05 .
-RESULTS	Change in prevalence of anemia in fish meal-vitamin C group ( 19.5 % ) was different compared to those of vitamin C group ( 9.3 % ) and the control ( 12.2 % ) .
-RESULTS	Levels of malaria parasitemia and high CRP among study participants at baseline and end line were 58 % and 80 % then 55 % and 79 % , respectively .
-RESULTS	Level of hookworm infestation was 13 % .
-CONCLUSIONS	Cowpea-based food containing 3 % fish meal and served with vitamin C-rich drink improved hemoglobin concentration and minimized the prevalence of anemia among the study participants .
-
-###25444575
-BACKGROUND	Mild cognitive impairment ( MCI ) increases dementia risk with no pharmacologic treatment available .
-METHODS	The Study of Mental and Resistance Training was a randomized , double-blind , double-sham controlled trial of adults with MCI .
-METHODS	Participants were randomized to 2 supervised interventions : active or sham physical training ( high intensity progressive resistance training vs seated calisthenics ) plus active or sham cognitive training ( computerized , multidomain cognitive training vs watching videos/quizzes ) , 2-3 days/week for 6 months with 18-month follow-up .
-METHODS	Primary outcomes were global cognitive function ( Alzheimer 's Disease Assessment Scale-cognitive subscale ; ADAS-Cog ) and functional independence ( Bayer Activities of Daily Living ) .
-METHODS	Secondary outcomes included executive function , memory , and speed/attention tests , and cognitive domain scores .
-RESULTS	One hundred adults with MCI [ 70.1 ( 6.7 ) years ; 68 % women ] were enrolled and analyzed .
-RESULTS	Resistance training significantly improved the primary outcome ADAS-Cog ; [ relative effect size ( 95 % confidence interval ) -0.33 ( -0.73 , 0.06 ) ; P < .05 ] at 6 months and executive function ( Wechsler Adult Intelligence Scale Matrices ; P = .016 ) across 18 months .
-RESULTS	Normal ADAS-Cog scores occurred in 48 % ( 24/49 ) after resistance training vs 27 % ( 14/51 ) without resistance training [ P < .03 ; odds ratio ( 95 % confidence interval ) 3.50 ( 1.18 , 10.48 ) ] .
-RESULTS	Cognitive training only attenuated decline in Memory Domain at 6 months ( P < .02 ) .
-RESULTS	Resistance training 18-month benefit was 74 % higher ( P = .02 ) for Executive Domain compared with combined training [ z-score change = 0.42 ( 0.22 , 0.63 ) resistance training vs 0.11 ( -0.60 , 0.28 ) combined ] and 48 % higher ( P < .04 ) for Global Domain [ z-score change = .0.45 ( 0.29 , 0.61 ) resistance training vs 0.23 ( 0.10 , 0.36 ) combined ] .
-CONCLUSIONS	Resistance training significantly improved global cognitive function , with maintenance of executive and global benefits over 18 months .
-
-###25027552
-BACKGROUND	We performed a randomized , non-comparative phase II study evaluating docetaxel in combination with either daily continuous ( protracted IV ) 5-fluorouracil or cisplatin administered weekly , concurrent to radiotherapy in the treatment of locally advanced pancreatic carcinoma .
-BACKGROUND	Results of the docetaxel plus cisplatin regimen are reported .
-METHODS	Forty chemotherapy-naive patients with locally advanced pancreatic carcinoma were randomly assigned to receive 5-fluorouracil and docetaxel or docetaxel 20mg/m ( 2 ) and cisplatin 20mg/m ( 2 ) / week , plus concurrent radiotherapy for 6 weeks .
-METHODS	The radiation dose to the primary tumour was 54Gy in 30 fractions .
-METHODS	The trial 's primary endpoint was the 6-month crude non-progression rate .
-RESULTS	51 patients from 7 centres were included in the docetaxel-cisplatin treatment group .
-RESULTS	Six-month non-progression rate was 39 % ( 95 % confidence interval : 26-53 ) .
-RESULTS	Median overall survival was 9.6 months ( 95 % confidence interval : 2.4-60 .7 ) ; 6 complete and 8 partial responses were obtained .
-RESULTS	Six patients survived more than 2 years after their inclusion in the trial .
-RESULTS	Grade 3 toxicity was reported in 63 % of patients ; no treatment-related death occurred .
-RESULTS	Severe toxicities were mainly anorexia ( 22 % ) , vomiting ( 20 % ) and fatigue ( 24 % ) .
-CONCLUSIONS	Despite inadequate efficacy according to the main end point , this regimen gave a satisfactory rate of objective response ( 27 % ) with tolerable toxicity .
-
-###24911076
-BACKGROUND	Recombinant granulocyte colony-stimulating factor ( G-CSF ) is widely used to mobilize haematopoietic stem cells .
-BACKGROUND	We compared the efficacy and safety of a biosimilar G-CSF ( Zarzio ( ) , Sandoz Biopharmaceuticals ) with the originator G-CSF ( Neupogen ( ) , Amgen ) in patients with haematological malignancies .
-METHODS	A total of 108 patients were included in this study , 59 of whom were female ( 49 male ) , with an overall median age of 51 years ( range 19-69 ) .
-METHODS	Patients had multiple myeloma ( n = 46 ) , non-Hodgkin 's lymphoma ( n = 28 ) , Hodgkin 's lymphoma ( n = 26 ) , or other diagnosis ( n = 8 ) .
-METHODS	After administration of mobilizing regimens ( primarily high-dose etoposide , high-dose cyclophosphamide , intermediate-dose Ara-C or ESHAP ) , patients were randomized to a standard daily 10 g/kg dose of biosimilar G-CSF ( n = 54 ) or originator G-CSF ( n = 54 ) .
-RESULTS	Median duration of G-CSF administration was 8 days with both biosimilar G-CSF ( range 4-17 ) and originator G-CSF ( range 4-14 ) .
-RESULTS	Both groups had a median of one apheresis with a median time until first apheresis of 11 days .
-RESULTS	There were no statistically significant differences between groups in the mean SD number of mobilized CD34 + cells/L in peripheral blood or the number of CD34 + cells/kg body weight .
-RESULTS	Five patients ( 9 % ) in the originator G-CSF group and six patients in the biosimilar G-CSF group ( 11 % ) did not mobilize sufficient CD34 + cells .
-RESULTS	The adverse event profile was similar between groups .
-CONCLUSIONS	A biosimilar G-CSF ( Zarzio ( ) ) demonstrated similar efficacy and safety as the reference originator G-CSF ( Neupogen ( ) ) in hematopoietic stem cell mobilization in patients with haematological malignancies .
-
-###24369433
-BACKGROUND	The standardized patient approach has proved to be an effective training tool for medical educators .
-BACKGROUND	This article explains the process of employing standardized patients in an HIV stigma reduction intervention in healthcare settings in China .
-METHODS	The study was conducted in 40 hospitals in two provinces of China .
-METHODS	One year after the stigma reduction intervention , standardized patients made unannounced visits to participating hospitals , randomly approached service providers on duty and presented symptoms related to HIV and disclosed HIV-positive test results .
-METHODS	After each visit , the standardized patients evaluated their providers ' attitudes and behaviours using a structured checklist .
-METHODS	Standardized patients also took open-ended observation notes about their experience and the evaluation process .
-RESULTS	Seven standardized patients conducted a total of 217 assessments ( 108 from 20 hospitals in the intervention condition ; 109 from 20 hospitals in the control condition ) .
-RESULTS	Based on a comparative analysis , the intervention hospitals received a better rating than the control hospitals in terms of general impression and universal precaution compliance as well as a lower score on stigmatizing attitudes and behaviours toward the standardized patients .
-CONCLUSIONS	Standardized patients are a useful supplement to traditional self-report assessments , particularly for measuring intervention outcomes that are sensitive or prone to social desirability .
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-###25683074
-BACKGROUND	Anecdotal reports have demonstrated the feasibility of needle aspiration to deflate a distended bowel , but we do not know of any prospective study that has evaluated this technique .
-BACKGROUND	We designed a controlled study to evaluate the use of the selective transperitoneal needle aspiration of a bowel loop ( STAB ) in infants .
-METHODS	Candidates were patients of less than 6 months of age , scheduled for laparoscopic Nissen fundoplication , in whom severe colonic distension was observed .
-METHODS	We randomized the patients to the study drug or placebo in a 1:1 mode .
-METHODS	The treatment group received STAB , whereas the control group was subject to conventional maneuvers .
-METHODS	We performed 403 Nissen procedures laparoscopically : 102 were in infants 6 months old , but only 44 presented severe transverse colonic distension .
-RESULTS	STAB facilitated the surgical procedure and drastically reduced surgical time .
-RESULTS	Thus , we calculated our sample size with use of the following inputs : 90 % power , a critical P value of .05 , and 50 % reduction in surgical time .
-RESULTS	This resulted in a necessary sample size of 21 subjects per group , for a total required sample size of 42 subjects .
-RESULTS	STAB procedures were done in 23 patients , and conventional measures were used in 21 .
-RESULTS	STAB was attempted a total of 45 times .
-RESULTS	Mean operative time was shorter in the STAB group .
-CONCLUSIONS	We propose the use of STAB as alternative therapy to decompress a dilated large-bowel loop during laparoscopic surgery .
-CONCLUSIONS	This maneuver is simple and efficient and has no clinical complications .
-CONCLUSIONS	Future studies are required to evaluate its role in the subset of other patients or procedures .
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-###24368867
-BACKGROUND	The traditional oxygen delivery methods for oxygen therapy are continuous flow oxygen ( CFO ) and demand oxygen delivery ( DOD ) ; however , oxygen waste is considerable in CFO , while DOD is uncomfortable for patients .
-BACKGROUND	Synchronized DOD ( SDOD ) , which was designed to overcome the drawbacks of both CFO and DOD , supplies oxygen according to the patient 's breathing pattern and the desired oxygen saving .
-BACKGROUND	This study was conducted to examine the overall performance of SDOD in terms of oxygen saturation ( SpO2 ) , patients ' comfort , and oxygen saving ratio ( SR ) .
-METHODS	Study subjects were patients who required oxygen for COPD or pneumonia .
-METHODS	Patients received oxygen through nasal prongs by CFO and SDOD for 30 min each .
-METHODS	SpO2 was measured every 10 min by pulse oximetry , and subjects recorded their level of comfort after 30 min .
-METHODS	The flow of discharged oxygen was recorded to calculate SR. .
-RESULTS	Ten subjects ( median age , 68 y ; range , 56-86 y ) were enrolled .
-RESULTS	The SpO2 of patients during SDOD ( 97 2 % ) was similar to that during CFO ( 96 3 % ) with no statistically significant difference ( P = .53 ) .
-RESULTS	Subjects reported SDOD to be more comfortable than CFO .
-RESULTS	The comfort score of subjects treated with SDOD was 7.05 2.07 ( 0 : very uncomfortable , 10 : very comfortable ) ; this was significantly higher ( P = .02 ) than the comfort score ( 5.20 1.83 ) of subjects treated with CFO .
-RESULTS	The SR values set by clinicians were very similar to calculated SR values .
-CONCLUSIONS	SDOD appears to be more suitable for oxygen therapy than CFO when considering SpO2 , patients ' comfort , and SR. .
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-###25833784
-BACKGROUND	In Haiti and other countries , large-scale investments in school feeding programs have been made with marginal evidence of nutrition outcomes .
-OBJECTIVE	We aimed to examine the effectiveness of a fortified ready-to-use supplementary food ( RUSF ) , Mamba , on reduced anemia and improved body composition in school-aged children compared to an unfortified cereal bar , Tablet Yo , and control groups .
-METHODS	A cluster , randomized trial with children ages 3-13 y ( n = 1167 ) was conducted in the north of Haiti .
-METHODS	Six schools were matched and randomized to the control group , Tablet Yo group ( 42 g , 165 kcal ) , or Mamba group ( 50 g , 260 kcal , and > 75 % of the RDA for critical micronutrients ) .
-METHODS	Children in the supplementation groups received the snack daily for 100 d , and all were followed longitudinally for hemoglobin concentrations , anthropometry , and bioelectrical impedance measures : baseline ( December 2012 ) , midline ( March 2013 ) , and endline ( June 2013 ) .
-METHODS	Parent surveys were conducted at baseline and endline to examine secondary outcomes of morbidities and dietary intakes .
-METHODS	Longitudinal regression modeling using generalized least squares and logit with random effects tested the main effects .
-RESULTS	At baseline ,14.0 % of children were stunted , 14.5 % underweight , 9.1 % thin , and 73 % anemic .
-RESULTS	Fat mass percentage ( mean SD ) was 8.1 % 4.3 % for boys and 12.5 % 4.4 % for girls .
-RESULTS	In longitudinal modeling , Mamba supplementation increased body mass index z score ( regression coefficient SEE ) 0.25 0.06 , fat mass 0.45 0.14 kg , and percentage fat mass 1.28 % 0.27 % compared with control at each time point ( P < 0.001 ) .
-RESULTS	Among boys , Mamba increased fat mass ( regression coefficient SEE ) 0.73 0.19 kg and fat-free mass 0.62 0.34 kg compared with control ( P < 0.001 ) .
-RESULTS	Mamba reduced the odds of developing anemia by 28 % compared to control ( adjusted OR : 0.72 ; 95 % CI : 0.57 , 0.91 ; P < 0.001 ) .
-RESULTS	No treatment effect was found for hemoglobin concentration .
-CONCLUSIONS	To our knowledge , this is the first study to give evidence of body composition effects from an RUSF in school-aged children .
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-###24402740
-OBJECTIVE	To examine the effect of incentive spirometry in pulmonary rehabilitation of chronic obstructive pulmonary disease ( COPD ) patients and compare its efficacy with inspiratory resistive muscle training ( IMT ) technique .
-METHODS	Randomized controlled trial .
-METHODS	Thirty patients with COPD , from a general hospital in Mashhad , Iran , were randomly assigned to two study groups .
-METHODS	All subjects trained daily in two 15-minute sessions , 4 days a week , for 4 weeks .
-METHODS	Respiratory function tests were compared before interventions and at the end of weeks 2 and 4 .
-RESULTS	Both techniques improved the mean values of all respiratory function tests ( p. 01 ) .
-RESULTS	The IMT technique was more effective to improve MVV and PImax ( p. 05 ) .
-RESULTS	PEFR was better improved in the incentive spirometry group ( p. 05 ) .
-RESULTS	There was no significant difference for other spirometric parameters between two groups .
-CONCLUSIONS	Incentive spirometry can be considered as an effective component for pulmonary rehabilitation in COPD patients .
-
-###25638011
-OBJECTIVE	Secukinumab , a fully human anti-interleukin-17A monoclonal antibody , exhibited promising activity in a proof-of-concept study when administered in intravenous ( IV ) doses to patients with active , chronic , noninfectious uveitis .
-OBJECTIVE	This study compared the efficacy and safety of different IV and subcutaneous ( SC ) doses of secukinumab in patients with noninfectious uveitis .
-METHODS	Multicenter , randomized , double-masked , dose-ranging , phase 2 clinical trial .
-METHODS	Thirty-seven patients with active noninfectious intermediate uveitis , posterior uveitis , or panuveitis who required corticosteroid-sparing immunosuppressive therapy .
-METHODS	Patients were randomized to secukinumab 300 mg SC every 2 weeks for 4 doses , secukinumab 10 mg/kg IV every 2 weeks for 4 doses , or secukinumab 30 mg/kg IV every 4 weeks for 2 doses .
-METHODS	Intravenous or SC saline was administered to maintain masking .
-METHODS	Efficacy was assessed on day 57 ( 2-4 weeks after last dose ) .
-METHODS	Percentage of patients with treatment response , defined as ( 1 ) at least a 2-grade reduction in vitreous haze score or trace or absent vitreous haze in the study eye without an increase in corticosteroid dose and without uveitis worsening or ( 2 ) reduction in corticosteroid dosages to prespecified levels without uveitis worsening .
-METHODS	Percentage of patients with remission , defined as anterior chamber cell and vitreous haze scores of 0 or 0.5 + in both eyes without corticosteroid therapy or uveitis worsening .
-RESULTS	Secukinumab 30 mg/kg IV and 10 mg/kg IV , compared with the 300 mg SC dose , produced higher responder rates ( 72.7 % and 61.5 % vs. 33.3 % , respectively ) and remission rates ( 27.3 % and 38.5 % vs. 16.7 % , respectively ) .
-RESULTS	Statistical and clinical superiority for the 30 mg/kg IV dose compared with the 300 mg SC dose was established in a Bayesian probability model .
-RESULTS	Other measures , including time to response onset , change in visual acuity , and change in vitreous haze score , showed numeric trends favoring IV dosing .
-RESULTS	Secukinumab , administered in IV or SC formulations , appeared safe and was well tolerated .
-CONCLUSIONS	Intravenous secukinumab was effective and well tolerated in noninfectious uveitis requiring systemic corticosteroid-sparing immunosuppressive therapy .
-CONCLUSIONS	Greater activity with IV dosing suggests that patients may not receive sufficient drug with SC administration .
-CONCLUSIONS	High-dose IV secukinumab may be necessary to deliver secukinumab in therapeutic concentrations .
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-###25151903
-OBJECTIVE	To explore the effects of walking exercise during late trimester on pregnancy outcome of low-risk primipara .
-METHODS	A prospective randomized controlled study was conducted for 123 cases of low-risk primipara who had regular prenatal care at Shengjing Hospital , China Medical University from July 2012 to June 2013 .
-METHODS	And informed consent was obtained .
-METHODS	The control group included 116 cases of other low-risk primipara in the same period .
-METHODS	Except that the experimental group had regular structured walking exercise from 34 weeks of gestational age to delivery , other consulting guidance were the same as the control group .
-METHODS	The inter-group differences , such as delivery mode , mean body weight gain per week after 34 weeks of gestation , duration of labor , labor pain perception , neonatal weight and neonatal birth condition , were detected and analyzed .
-RESULTS	Finally there were 13 and 8 dropouts in experimental and control groups respectively .
-RESULTS	For two groups , the rate of caesarean section was 12.7 % and 18.5 % , the mean body weight gain per week after 34 weeks of gestational age ( 0.41 0.13 ) and ( 0.56 0.09 ) kg , the labor pain score are 6.1 1.9 and 7.6 2.3 , the duration of labor ( 12 4 ) and ( 15 6 ) h , the neonatal birth weight ( 3.4 0.3 ) and ( 3.7 0.6 ) kg and the rate of macrosomia 4.5 % and 7.4 % respectively .
-RESULTS	The differences had statistical significance ( P < 0.05 ) .
-RESULTS	The rate of preterm birth was 5.5 % and 4.6 % , the rate of premature rupture of membrane 15.5 % and 13.9 % and the rate of neonatal asphyxia 2.7 % and 3.7 % respectively .
-RESULTS	The differences had no statistical significance ( all P > 0.05 ) .
-CONCLUSIONS	Simple , safe and effective , walking exercise during late trimester may improve the pregnancy outcomes of low-risk primipara .
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-###25416724
-OBJECTIVE	Visceral adipose tissue ( VAT ) is associated with an increased risk of metabolic syndrome ( MetS ) .
-OBJECTIVE	Recent studies have suggested that VAT negatively affects bone .
-OBJECTIVE	However , MetS has also been associated with higher estradiol ( E2 ) levels , which is bone protective .
-OBJECTIVE	We therefore investigated the impact of VAT and E2 levels on bone density , structural parameters , and strength estimates .
-METHODS	A cross-sectional study was conducted in 72 obese men with MetS to investigate the impact of VAT and E2 levels on bone .
-METHODS	Bone parameters were assessed by dual-energy X-ray absorptiometry ( DXA ) , quantitative computed tomography ( QCT ) , and high-resolution peripheral QCT ( HRpQCT ) at lumbar spine , proximal femur , radius , and tibia .
-METHODS	VAT volume was measured by magnetic resonance imaging ( MRI ) and sexual hormones were measured in blood samples .
-RESULTS	Men with high VAT had a lower bone density at the hip ( P < 0.05 ) , lower cortical thickness , and higher buckling ratio at femoral neck ( FN ) ( P = 0.008 and P = 0.02 ) , compared with men with low VAT , despite a similar body weight and BMI .
-RESULTS	Generally , E2 levels were low ( median 43pmol/l ) , and men with E2 levels below median had reduced bone density at lumbar spine ( P = 0.04 ) , and impaired structural parameters at radius and tibia , compared with men with E2 levels above median .
-RESULTS	At the hip , VAT volume and E2 levels affected bone density independently and additively , and 50 % of men with high VAT and low E2 levels had osteopenia with significantly lower T-score at FN ( P = 0.004 ) .
-CONCLUSIONS	High VAT and low E2 negatively affect bone in obese men with MetS .
-CONCLUSIONS	VAT and E2 affect bone density at the hip independently and additively , revealing an unexpected high prevalence of osteopenia in middle-aged men with MetS .
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-###25070960
-OBJECTIVE	Thromboxane prostaglandin receptors have been implicated to be involved in the atherosclerotic process .
-OBJECTIVE	We assessed whether Terutroban , a thromboxane prostaglandin receptor antagonist , affects the progression of atherosclerosis , as measured by common carotid intima-media thickness and carotid plaques .
-METHODS	A substudy was performed among 1141 participants of the aspirin-controlled Prevention of Cerebrovascular and Cardiovascular Events of Ischemic Origin with Terutroban in Patients with a History of Ischemic Stroke or Transient Ischemic Attack ( PERFORM ) trial .
-METHODS	Common carotid intima-media thickness and carotid plaque occurrence was measured during a 3-year period .
-RESULTS	Baseline characteristics did not differ between Terutroban ( n = 592 ) and aspirin ( n = 549 ) treated patients and were similar as in the main study .
-RESULTS	Mean study and treatment duration were similar ( 28 and 25 months , respectively ) .
-RESULTS	In the Terutroban group , the annualized rate of change in common carotid intima-media thickness was 0.006 mm per year ( 95 % confidence interval , -0.004 to 0.016 ) and -0.005 mm per year ( 95 % confidence interval , -0.015 to 0.005 ) in the aspirin group .
-RESULTS	There was no statistically significant difference between the groups in the annualized rate of change of common carotid intima-media thickness ( 0.011 mm per year ; 95 % confidence interval , -0.003 to 0.025 ) .
-RESULTS	At 12 months of follow-up , 66 % of Terutroban patients had no emergent plaques , 31 % had 1 to 2 emergent plaques , and 3 % had 3 emergent plaques .
-RESULTS	In the aspirin group , the corresponding percentages were 64 % , 32 % , and 4 % .
-RESULTS	Over time , there was no statistically significant difference in the number of emergent carotid plaques between treatment modalities ( rate ratio , 0.91 ; 95 % confidence interval , 0.77-1 .07 ) .
-CONCLUSIONS	Compared with aspirin , Terutroban did not beneficially affect progression of carotid atherosclerosis among well-treated patients with a history of ischemic stroke or transient ischemic attacks with an internal carotid stenosis < 70 % .
-BACKGROUND	http://www.controlled-trials.com .
-BACKGROUND	Unique identifier : ISRCTN66157730 .
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-###24300843
-OBJECTIVE	The objectives of the study were to evaluate the image quality and diagnostic performance of sinogram-affirmed iterative reconstruction ( SAFIRE ) for detecting hepatic metastasis and to estimate the potential radiation dose reduction at abdominal computed tomography ( CT ) .
-METHODS	Fifty-nine consecutive patients ( mean age , 59.2 years ; range , 42-81 years ) who had hepatic metastasis and who underwent dual-source abdominal CT were enrolled in this study .
-METHODS	The image noise of the liver was compared between full-dose filtered back projection images ( FD-FBP ) and simulated half-dose images , which used only single-source projection data , and reconstructed with different strengths of SAFIRE ( HD-SAFIRE ( 1-5 ) ) by 1-way analysis of variance with Bonferroni correction .
-METHODS	The diagnostic performance for hepatic metastasis was compared by logistic regression with the weighted least squares method and noninferiority test between the FD-FBP images and the half-dose sinogram-affirmed iterative reconstruction ( HD-SAFIRE ) images .
-RESULTS	As the SAFIRE strength increased , image noise decreased ( P < 0.001 ) .
-RESULTS	The images of HD-SAFIRE ( 2 ) showed similar image noise for liver parenchyma ( 13.4 Hounsfield unit [ HU ] ) , signal-to-noise ratio for liver parenchyma ( 9.2 ) , and lesion-to-liver contrast-to-noise ratio ( 4.5 ) , compared with the FD-FBP images ( 12.6 HU , P = 0.668 ; 9.6 , P > 0.999 ; and 4.5 , P > 0.999 , respectively ) .
-RESULTS	The diagnostic accuracy for hepatic metastasis with the HD-SAFIRE ( 2 ) images ( 87.5 % ) was not different from that of the FD-FBP images ( 87.5 % , P > 0.999 ) .
-RESULTS	The diagnostic performance of the HD-SAFIRE ( 2 ) images was also noninferior to that of the FD-FBP images ( 95 % confidence interval lower limit difference [ -9.16 % ] excluding the -10 % clinical noninferiority limit ) .
-RESULTS	The mean ( SD ) volume CT dose index of FD-FBP was 11.26 ( 2.66 ) mGy , and the mean ( SD ) radiation dose equivalent associated with HD-SAFIRE was estimated to be 5.63 ( 1.33 ) mGy .
-CONCLUSIONS	By applying SAFIRE2 , the radiation dose could be reduced by up to 50 % compared with the standard-of-care abdominal CT protocol without increasing image noise and without deteriorating diagnostic performance for the detection of hepatic metastasis .
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-###24565089
-OBJECTIVE	Shoulder arthroscopic surgeries evolve with intense postoperative pain .
-OBJECTIVE	Several analgesic techniques have been advocated .
-OBJECTIVE	The aim of this study was to compare suprascapular and axillary nerve blocks in shoulder arthroscopy using the interscalene approach to brachial plexus blockade .
-METHODS	According to the technique used , sixty-eight patients were allocated into two groups : interscalene group ( IG , n = 34 ) and selective group ( SG , n = 34 ) , with neurostimulation approach used for both techniques .
-METHODS	After appropriate motor response , IG received 30 mL of 0.33 % levobupivacaine in 50 % enantiomeric excess with adrenalin 1:200,000 .
-METHODS	After motor response of suprascapular and axillary nerves , SG received 15 mL of the same substance on each nerve .
-METHODS	General anesthesia was then administered .
-METHODS	Variables assessed were time to perform the blocks , analgesia , opioid consumption , motor block , cardiovascular stability , patient satisfaction and acceptability .
-RESULTS	Time for interscalene blockade was significantly shorter than for selective blockade .
-RESULTS	Analgesia was significantly higher in the immediate postoperative period in IG and in the late postoperative period in SG .
-RESULTS	Morphine consumption was significantly higher in the first hour in SG .
-RESULTS	Motor block was significantly lower in SG .
-RESULTS	There was no difference between groups regarding cardiocirculatory stability and patient satisfaction and acceptability .
-RESULTS	Failure occurred in IG ( 1 ) and SG ( 2 ) .
-CONCLUSIONS	Both techniques are safe , effective , and with the same degree of satisfaction and acceptability .
-CONCLUSIONS	The selective blockade of both nerves showed satisfactory analgesia , with the advantage of providing motor block restricted to the shoulder .
-
-###25152289
-OBJECTIVE	To explore the effects of pri ming rocuronium on neuromuscular blockade produced by mivacurium .
-METHODS	Ethical approval was granted by the medical ethics committee of our hospital with a reference number of C-2013-018-01 .
-METHODS	A total of 120 ASA physical status I and II patients undergoing selective otorhinolaryngologic surgery under general anesthesia signed the form of informed consent .
-METHODS	And they were randomly divided by a random number table into 4 groups .
-METHODS	After a standardized imidazole-propofol-fentanyl induction , they received a saline placebo injection ( GroupI ) and a pri ming dose of rocuronium 0.06 mg/kg ( GroupII ) , rocuronium 0.075 mg/kg ( Group III ) and rocuronium 0.1 mg/kg ( Group IV ) .
-METHODS	An intubating dose of mivacurium 0.15 mg/kg was offered 3 minutes later .
-METHODS	Anesthesia was maintained with propofol and remifentanyl continuous infusion .
-METHODS	Neuromuscular block was monitored with train of four ( TOF ) stimulation .
-METHODS	The onset time , reappearance of T1 ( DUR TOFc 1 ) , times of T1 25 % and 75 % recovery , recovery index and times of TOF25 % , 75 % and 90 % recovery were recorded .
-RESULTS	The onset time of mivacurium was significantly shorter and the times of T1 25 % and 75 % recovery were significantly longer in groups of II , III and IV than those in groupI .
-RESULTS	No significant difference existed in recovery index among 4 groups .
-RESULTS	The onset time of mivacurium became progressively shorter with the growing pri ming dose of rocurium among three experiment groups .
-RESULTS	And it was not statistically significant .
-CONCLUSIONS	Pri ming rocuronium decreases the onset and intubating times of mivacurium without effect on recovery index .
-CONCLUSIONS	No significant difference exists in drug effect among 3 experiment groups .
-
-###24934544
-BACKGROUND	Oxidative stress and inflammation are two key mechanisms suggested to be involved in the pathogenesis of Alzheimer 's disease ( AD ) .
-BACKGROUND	Omega-3 fatty acids ( -3 FAs ) found in fish and fish oil have several biological properties that may be beneficial in AD .
-BACKGROUND	However , they may also auto-oxidize and induce in vivo lipid peroxidation .
-OBJECTIVE	The objective of this study was to evaluate systemic oxidative stress and inflammatory biomarkers following oral supplementation of dietary -3 FA .
-METHODS	Forty patients with moderate AD were randomized to receive 1.7 g DHA ( 22:6 ) and 0.6 g EPA ( 20:5 ) or placebo for 6 months .
-METHODS	Urinary samples were collected before and after supplementation .
-METHODS	The levels of the major F2-isoprostane , 8-iso-PGF2 , a consistent in vivo biomarker of oxidative stress , and 15-keto-dihydro-PGF2 , a major metabolite of PGF2 and biomarker of inflammatory response , were measured .
-RESULTS	F2-isoprostane in urine increased in the placebo group after 6 months , but there was no clear difference in treatment effect between supplemented and non-supplemented patients on the urinary levels of F2-isoprostanes and 15-keto-dihydro-PGF2 .
-RESULTS	At baseline , the levels of 15-keto-dihydro-PGF2 showed negative correlative relationships to -3 FAs , and a positive correlation to linoleic acid .
-RESULTS	8-iso-PGF2 correlated negatively to the -6 FA arachidonic acid .
-CONCLUSIONS	The findings indicate that supplementation of -3 FAs to patients with AD for 6 months does not have a clear effect on free radical-mediated formation of F2-isoprostane or cyclooxygenase-mediated formation of prostaglandin F2 .
-CONCLUSIONS	The correlative relationships to FAs indicate a potential role of FAs in immunoregulation .
-
-###24448652
-BACKGROUND	Morning dose or twice-daily proton pump inhibitor ( PPI ) use is often prescribed to heal severe reflux esophagitis .
-OBJECTIVE	Compare the effect of single dose morning ( control arm ) versus nighttime ( experimental arm ) omeprazole/sodium bicarbonate ( Zegerid ( ) ) ( IR-OME ) on esophagitis and gastroesophageal reflux symptoms .
-METHODS	Adult outpatients with Los Angeles grade C or D esophagitis were allocated to open-label 40 mg IR-OME once a day for 8 weeks in a prospective , randomized , parallel design , single center study .
-METHODS	Esophagogastroduodenoscopy ( EGD ) and validated self-report symptom questionnaires were completed at baseline and follow-up .
-METHODS	Intention-to-treat and per-protocol analyses were performed .
-RESULTS	Ninety-two of 128 ( 72 % ) eligible subjects participated [ 64 ( 70 % ) male , mean age 58 ( range 19-86 ) , median BMI 29 ( range 21-51 ) , 58 C :34 D ] .
-RESULTS	Overall , 81 ( 88 % ) subjects healed [ n = 70 ( 76 % ) ] or improved [ n = 11 ( 12 % ) ] erosions .
-RESULTS	There was no significant difference ( morning vs. night ) in mucosal healing [ 81 vs. 71 % , ( p = 0.44 ) ] or symptom resolution [ heartburn ( 77 vs. 65 % , p = 0.12 ) , acid regurgitation ( 82 vs. 73 % , p = 0.28 ) ] .
-RESULTS	Prevalence of newly identified Barrett 's esophagus was 14 % with half diagnosed only after treatment .
-CONCLUSIONS	Once-daily IR-OME ( taken morning or night ) effectively heals severe reflux esophagitis and improves GERD symptoms .
-CONCLUSIONS	Results support the clinical practice recommendation to repeat EGD after 8 weeks PPI therapy in severe esophagitis patients to assure healing and exclude Barrett 's esophagus .
-
-###25932701
-BACKGROUND	Alerts embedded in electronic health records ( EHRs ) are designed to improve processes at the point of care .
-OBJECTIVE	The aim of this study was to determine if an EHR alert-at emergency department ( ED ) triage-increases the ED triage nurse 's utilization of triage protocols .
-METHODS	ED triage nurses were randomized to receive either a passive EHR alert or no intervention for patients with the following complaints : minor trauma with extremity injuries or female patients with abdominal pain .
-METHODS	The EHR alert notified the nurse that the patient was eligible for diagnostic testing : radiographs for patients with injured extremities or urinalysis for female patients with abdominal pain .
-RESULTS	Twenty-eight nurses triaged 20,410 patients in the 6 months before the intervention and 19,157 in the 6 months after the intervention .
-RESULTS	Before the intervention , the urinalysis protocol was implemented in 101/624 ( 16.2 % ) patients triaged by the intervention group and 116/711 ( 16.3 % ) triaged by the control group .
-RESULTS	After the intervention , the urinalysis protocol was implemented in 146/530 ( 27.6 % ) patients triaged by the intervention group and 174/679 ( 25.6 % ) triaged by the control group .
-RESULTS	Before the intervention , the radiograph protocol was implemented in 58/774 ( 7.5 % ) patients triaged by the intervention group and 45/684 ( 6.6 % ) triaged by the control group .
-RESULTS	After the intervention , the radiograph protocol was implemented in 78/614 ( 12.7 % ) patients triaged by the intervention group and 79/609 ( 13.0 % ) triaged by the control group .
-CONCLUSIONS	The use of a passive EHR alert to promote ED triage protocols showed little benefit .
-CONCLUSIONS	Before the widespread implementation of EHR alerts for patient care , rigorous studies are required to determine the best alert methods and the impacts of such interventions .
-
-###26174905
-BACKGROUND	Hemolysis reaction is a rare class effect of therapy with intravenously administered human normal immunoglobulin ( IVIG ) .
-BACKGROUND	Anti-A/B isoagglutinins ( isohemagglutinins ) originating from donor plasma are considered a probable risk factor for hemolysis .
-BACKGROUND	We hypothesized that screening and exclusion of plasma obtained from donors with high isoagglutinin titers from the manufacturing process would produce a meaningful reduction of anti-A/B isoagglutinin titers of the final IVIG product .
-METHODS	A donor screening method for anti-A isoagglutinins using an automated indirect agglutination test ( IAT ) in gel cards was developed .
-METHODS	Industry-scale donor plasma pools and final IVIG product were prepared according to the manufacturing process of Privigen ( human 10 % liquid IVIG ) .
-METHODS	Anti-A/B isoagglutinin levels were measured by IAT , direct agglutination test , and a flow cytometry-based assay .
-RESULTS	Screening of plasma from 705 randomly selected donors identified 6.8 % donors with high anti-A isoagglutinin titers in plasma .
-RESULTS	Exclusion of plasma from these donors resulted in a one-titer-step reduction of anti-A isoagglutinin in laboratory-scale pooled plasma .
-RESULTS	The same donor screening method applied to industry-scale production resulted in exclusion of 5.1 % of donors and produced a one-titer-step reduction of both anti-A and anti-B isoagglutinin titers in the final IVIG product .
-CONCLUSIONS	Anti-A/B isoagglutinin titers in IVIG products can be reduced on an industrial scale through implementation of anti-A donor screening , which may lower the risk of hemolysis after IVIG therapy .
-
-###24853314
-BACKGROUND	Rectus sheath block can provide analgesia following umbilical hernia repair .
-BACKGROUND	However , conflicting reports on its analgesic effectiveness exist .
-BACKGROUND	No study has investigated plasma local anesthetic concentration following ultrasound-guided rectus sheath block ( USGRSB ) in children .
-OBJECTIVE	Compare the effectiveness and bupivacaine absorption following USGRSB or wound infiltration ( WI ) for umbilical hernia repair in children .
-METHODS	A randomized blinded study comparing WI with USGRSB in 40 children undergoing umbilical hernia repair was performed .
-METHODS	Group WI ( n = 20 ) received wound infiltration 1 mgkg ( -1 ) 0.25 % bupivacaine .
-METHODS	Group RS ( n = 20 ) received USGRSB 0.5 mgkg ( -1 ) 0.25 % bupivacaine per side in the posterior rectus sheath compartment .
-METHODS	Pain scores and rescue analgesia were recorded .
-METHODS	Blood samples were drawn at 0 , 10 , 20 , 30 , 45 , and 60 min .
-RESULTS	Patients in the WI group had a twofold increased risk of requiring morphine ( hazard ratio 2.06 , 95 % CI 1.01 , 4.20 , P = 0.05 ) .
-RESULTS	When required , median time to first morphine dose was longer in the USGRSB group ( 65.5 min vs. 47.5 min , P = 0.049 ) .
-RESULTS	Peak plasma bupivacaine concentration was higher following USGRSB than WI ( median : 631.9 ngml ( -1 ) IQR : 553.9-784 .1 vs. 389.7 ngml ( -1 ) IQR : 250.5-502 .7 , P = 0.002 ) .
-RESULTS	Tmax was longer in the USGRSB group ( median 45 min IQR : 30-60 vs. 20 min IQR : 20-45 , P = 0.006 ) .
-CONCLUSIONS	USGRSB provides more effective analgesia than WI for umbilical hernia repair .
-CONCLUSIONS	USGRSB with 1 mgkg ( -1 ) 0.25 % bupivacaine is associated with safe plasma bupivacaine concentration that peaks higher and later than WI .
-CONCLUSIONS	Caution against using larger volumes of higher concentration local anesthetic for USGRSB is advised .
-
-###25345427
-OBJECTIVE	Drug-drug interactions between canagliflozin , a sodium glucose co-transporter 2 inhibitor approved for the management of type-2 diabetes mellitus , and an oral contraceptive ( OC ) , warfarin , and digoxin were evaluated in three phase 1 studies in healthy participants .
-METHODS	All studies were open-label ; study 1 included a fixed-sequence design , and studies 2 and 3 used a crossover design .
-METHODS	Regimens were : study 1 : OC ( levonorgestrel ( 150 g ) + ethinyl estradiol ( 30 g ) ) / day ( day 1 ) , canagliflozin 200 mg/day ( days 4 - 8 ) , and canagliflozin with OC ( day 9 ) ; study 2 : canagliflozin 300 mg/day ( days 1 - 12 ) with warfarin 30 mg/day ( day 6 ) in period 1 , and only warfarin 30 mg/day ( day 1 ) in period 2 , or vice versa ; study 3 : digoxin alone ( 0.5 mg/day ( day 1 ) + 0.25 mg/day ( days 2 - 7 ) ) in period 1 , and with canagliflozin 300 mg/day ( days 1 - 7 ) in period 2 , or vice versa .
-METHODS	Pharmacokinetics ( PK ) were assessed at prespecified intervals ; OC : days 1 and 9 , canagliflozin : days 8 - 9 ( study 1 ) ; warfarin : days 6 ( period 1 ) and 1 ( period 2 ) ( study 2 ) ; and digoxin : days 5 - 7 ( periods 1 and 2 ) ( study 3 ) .
-METHODS	Warfarin 's pharmacodynamics ( PD ; International Normalized Ratio ( INR ) ) was assessed on days 6 ( period 1 ) and 1 ( period 2 ) .
-RESULTS	Canagliflozin increased the plasma exposure of OC ( maximum plasma concentration ( Cmax ) : 22 % , area under the curve ( AUC ) : 6 % ) and digoxin ( Cmax : 36 % , AUC : 20 % ) ; but did not alter warfarin 's PK and PD .
-RESULTS	No clinically relevant safety findings ( including hypoglycemia ) were noted .
-CONCLUSIONS	Canagliflozin can be coadministered with OC , warfarin , or digoxin without dose adjustments .
-CONCLUSIONS	All treatments were well-tolerated .
-
-###24270198
-OBJECTIVE	This study aimed to determine during 36 months of follow-up the ( 1 ) clinical outcomes and ( 2 ) influence of high-risk human papillomavirus ( HPV ) status on the risk of progression to cervical intraepithelial neoplasia 2 + ( CIN 2 + ) , among women with histologically proven CIN 1 .
-METHODS	This is an ad hoc analysis of women with CIN 1 within TOMBOLA , a randomized trial of the management of women with low-grade cervical cytology .
-METHODS	Women from the colposcopy arm with CIN 1 confirmed on punch biopsies and managed conservatively by cytology every 6 months in primary care were included .
-METHODS	Sociodemographic data and a sample for HPV testing were collected at recruitment .
-METHODS	Data on the sample women were extracted to calculate the cumulative incidence of CIN 2 + and the performance characteristics of the baseline HPV test .
-METHODS	Detection of CIN 2 or worse ( CIN 2 + ) during follow-up or at exit colposcopy was analyzed .
-RESULTS	A total of 171 women were included .
-RESULTS	Their median age was 29 years .
-RESULTS	Fifty-two percent were high-risk HPV positive , 17 % were HPV-16 positive , and 11 % were HPV-18 positive .
-RESULTS	Overall , 21 women ( 12 % ) developed CIN 2 + , with a median time to detection of 25 months .
-RESULTS	Factors associated with progression to CIN 2 + were presence of HPV-18 ( relative risk = 3.04 ; 95 % CI = 1.09-8 .44 ) and HPV-16 and/or HPV-18 at recruitment ( relative risk = 3.98 ; 95 % CI = 1.60-9 .90 ) .
-RESULTS	The sensitivity and specificity of a combined HPV-16 / HPV-18 test for the detection of CIN 2 + during 3 years were 58 % and 78 % , respectively .
-CONCLUSIONS	Our results suggest that women with confirmed CIN 1 have low rates of progression to high-grade CIN within 3 years .
-CONCLUSIONS	Because the median time to progression was 25 months , conservative management could recommend the next repeat cytology at 2 years .
-
-###24835757
-OBJECTIVE	To determine longitudinal changes in angle configuration in the eyes of primary angle-closure suspects ( PACS ) treated by laser peripheral iridotomy ( LPI ) and in untreated fellow eyes .
-METHODS	Longitudinal cohort study .
-METHODS	Primary angle-closure suspects aged 50 to 70 years were enrolled in a randomized , controlled clinical trial .
-METHODS	Each participant was treated by LPI in 1 randomly selected eye , with the fellow eye serving as a control .
-METHODS	Angle width was assessed in a masked fashion using gonioscopy and anterior segment optical coherence tomography ( AS-OCT ) before and at 2 weeks , 6 months , and 18 months after LPI .
-METHODS	Angle width in degrees was calculated from Shaffer grades assessed under static gonioscopy .
-METHODS	Angle configuration was also evaluated using angle opening distance ( AOD250 , AOD500 , AOD750 ) , trabecular-iris space area ( TISA500 , TISA750 ) , and angle recess area ( ARA ) measured in AS-OCT images .
-RESULTS	No significant difference was found in baseline measures of angle configuration between treated and untreated eyes .
-RESULTS	At 2 weeks after LPI , the drainage angle on gonioscopy widened from a mean of 13.5 at baseline to a mean of 25.7 in treated eyes , which was also confirmed by significant increases in all AS-OCT angle width measures ( P < 0.001 for all variables ) .
-RESULTS	Between 2 weeks and 18 months after LPI , a significant decrease in angle width was observed over time in treated eyes ( P < 0.001 for all variables ) , although the change over the first 5.5 months was not statistically significant for angle width measured under gonioscopy ( P = 0.18 ) , AOD250 ( P = 0.167 ) and ARA ( P = 0.83 ) .
-RESULTS	In untreated eyes , angle width consistently decreased across all follow-up visits after LPI , with a more rapid longitudinal decrease compared with treated eyes ( P values for all variables 0.003 ) .
-RESULTS	The annual rate of change in angle width was equivalent to 1.2 / year ( 95 % confidence interval [ CI ] , 0.8-1 .6 ) in treated eyes and 1.6 / year ( 95 % CI , 1.3-2 .0 ) in untreated eyes ( P < 0.001 ) .
-CONCLUSIONS	Angle width of treated eyes increased markedly after LPI , remained stable for 6 months , and then decreased significantly by 18 months after LPI .
-CONCLUSIONS	Untreated eyes experienced a more consistent and rapid decrease in angle width over the same time period .
-
-###25541333
-OBJECTIVE	Chronic pain and progressive loss of physical function with AS may adversely affect health-related quality of life ( HRQoL ) .
-OBJECTIVE	The objective of this study was to assess the 5-year data regarding spinal mobility , physical function and HRQoL in patients with AS who participated in the Adalimumab Trial Evaluating Long-term Efficacy and Safety for AS ( ATLAS ) study .
-METHODS	Patients received blinded adalimumab 40 mg or placebo every other week for 24 weeks , then open-label adalimumab for up to 5 years .
-METHODS	Spinal mobility was evaluated using linear BASMI ( BASMIlin ) .
-METHODS	BASDAI , total back pain , CRP , BASFI , Short Form-36 and AS quality of life ( ASQoL ) were also assessed .
-METHODS	Correlations between BASMIlin and clinical , functional and ASQoL outcomes after 12 weeks and after 5years of adalimumab exposure were evaluated using Spearman 's rank correlation .
-METHODS	Associations were further analysed using multivariate regression .
-RESULTS	Three hundred and eleven patients received 1 dose of adalimumab ; 125 of the 208 patients originally randomized to adalimumab received treatment for 5 years .
-RESULTS	Improvements in BASMIlin were sustained through 5 years , with a mean change of -0.6 from baseline in the population who completed 5 years of treatment with adalimumab .
-RESULTS	Improvements in disease activity , physical function and ASQoL were also sustained through 5 years .
-RESULTS	BASMIlin was significantly correlated with all evaluated clinical outcomes ( P < 0.001 ) .
-RESULTS	The highest correlation was with BASFI at 12 weeks ( r = 0.52 ) and at 5 years ( r = 0.65 ) .
-RESULTS	Multivariate regression analysis confirmed this association ( P < 0.001 ) .
-CONCLUSIONS	Treatment with adalimumab for up to 5 years demonstrated sustained benefits in spinal mobility , disease activity , physical function and HRQoL in patients with active AS .
-CONCLUSIONS	Spinal mobility was significantly associated with short - and long-term physical function in these patients .
-BACKGROUND	Clinicaltrials.gov ; https://clinicaltrials.gov/NCT00085644 .
-
-###24680759
-BACKGROUND	The intragastric balloon has been reported to be a safe and effective tool for temporary weight loss .
-BACKGROUND	The aim of this study is the evaluation of the possible predictive role of intragastric balloon when used before laparoscopic adjustable gastric banding .
-METHODS	A longitudinal multicenter study was conducted in patients with body mass index ( BMI ) > 35 kg/m ( 2 ) who underwent gastric banding with the BioEnterics Intragastric Balloon ( BIB ) .
-METHODS	After balloon removal ( 6 mo ) , patients were allocated into 2 group according to their percentage of excess weight loss ( % EWL ) : group > 25 ( % EWL > 25 % ) and group < 25 ( % EWL < 25 % ) .
-METHODS	Patients from both group underwent laparoscopic adjustable gastric banding ( LAGB ) 1-3 months after BIB removal .
-METHODS	The LAP-BAND AP band was placed in all patients via pars flaccida .
-METHODS	Weight loss parameters were considered in both groups .
-RESULTS	From January 2005 to December 2009 , 1357 patients were enrolled in this study .
-RESULTS	Mean BMI at time of BIB positioning was 44.98.4 ( range 29-82 .5 ) .
-RESULTS	After 6 months , at time of removal , mean BMI was 39.47.3 .
-RESULTS	According to the cutoff , patients were allocated into group A ( n = 699 ) and group B ( n = 658 ) .
-RESULTS	At this time the mean BMI was 36.46.4 and 42.76.9 ( P = .001 ) in groups A and B , respectively .
-RESULTS	At 1-year follow-up from LAGB , mean BMI was 35.86.5 and 40.07.4 ( P < .001 ) in groups A and B , respectively .
-RESULTS	This significant difference was confirmed at 3 - and 5-year follow-ups .
-RESULTS	A similar pattern was observed with the % EWL .
-CONCLUSIONS	Satisfactory results with BIB are predictive of a positive outcome of LASB at 1 , 3 , and 5 years after the procedure , and poor results do not inevitably indicate a negative outcome for gastric banding .
-
-###25297013
-BACKGROUND	Calcitonin gene-related peptide ( CGRP ) is crucial in the pathophysiology of migraine .
-BACKGROUND	We assessed the safety , tolerability , and efficacy of ALD403 , a genetically engineered humanised anti-CGRP antibody , for migraine prevention .
-METHODS	In this randomised , double-blind , placebo-controlled , exploratory , proof-of-concept phase 2 trial , patients aged 18-55 years with five to 14 migraine days per 28-day period were randomly assigned ( 1:1 ) via an interactive web response system to receive an intravenous dose of ALD403 1000 mg or placebo .
-METHODS	Site investigators , patients , and the sponsor were masked to treatment allocation during the study .
-METHODS	The primary objective was to assess safety at 12 weeks after infusion .
-METHODS	The primary efficacy endpoint was the change from baseline to weeks 5-8 in the frequency of migraine days , as recorded in patient electronic diaries .
-METHODS	Patients were followed up until 24 weeks for exploratory safety and efficacy analyses .
-METHODS	Safety and efficacy analyses were done by intention to treat .
-METHODS	This study is registered with ClinicalTrials.gov , NCT01772524 .
-RESULTS	Between Jan 28 , 2013 , and Dec 23 , 2013 , of 174 patients randomly assigned at 26 centres in the USA , 163 received either ALD403 ( n = 81 ) or placebo ( n = 82 ) .
-RESULTS	Adverse events were experienced by 46 ( 57 % ) of 81 patients in the ALD403 group and 43 ( 52 % ) of 82 in the placebo group .
-RESULTS	The most frequent adverse events were upper respiratory tract infection ( placebo 6 [ 7 % ] patients vs ALD403 7 [ 9 % ] patients ) , urinary tract infection ( 4 [ 5 % ] vs 1 [ 1 % ] ) , fatigue ( 3 [ 4 % ] vs 3 [ 4 % ] ) , back pain ( 4 [ 5 % ] vs 3 [ 4 % ] ) , arthralgia ( 4 [ 5 % ] vs 1 [ 1 % ] ) , and nausea and vomiting ( 2 [ 2 % ] vs 3 [ 4 % ] ) .
-RESULTS	Six serious adverse events were reported by three patients and were judged to be unrelated to study drug : in the ALD403 group , one patient had four serious adverse events and one had one serious adverse event , and in the placebo group , one patient had one serious adverse event .
-RESULTS	There were no differences in vital signs or laboratory safety data between the two treatment groups .
-RESULTS	The mean change in migraine days between baseline and weeks 5-8 was -56 ( SD 30 ) for the ALD403 group compared with -46 ( 36 ) for the placebo group ( difference -10 , 95 % CI -20 to 01 ; one-sided p = 00306 ) .
-CONCLUSIONS	No safety concerns were noted with an intravenous dose of ALD403 1000 mg .
-CONCLUSIONS	This study also provides preliminary evidence for the efficacy of ALD403 in the preventive treatment of migraine in patients with a high monthly frequency of migraine days .
-BACKGROUND	Alder Biopharmaceuticals .
-
-###25111236
-OBJECTIVE	Polycystic liver disease ( PLD ) , the most common extrarenal manifestation of autosomal-dominant polycystic kidney disease ( ADPKD ) , has become more prevalent as a result of increased life expectancy , improved renal survival , reduced cardiovascular mortality , and renal replacement therapy .
-OBJECTIVE	No studies have fully characterized PLD in large cohorts .
-OBJECTIVE	We investigated whether liver and cyst volumes are associated with volume of the hepatic parenchyma , results from liver laboratory tests , and patient-reported outcomes .
-METHODS	We performed a cross-sectional analysis of baseline liver volumes , measured by magnetic resonance imaging , and their association with demographics , results from liver laboratory and other tests , and quality of life .
-METHODS	The data were collected from a randomized , placebo-controlled trial underway at 7 tertiary-care medical centers to determine whether the combination of an angiotensin I-converting enzyme inhibitor and angiotensin II-receptor blocker was superior to the inhibitor alone , and whether low blood pressure ( < 110/75 mm Hg ) was superior to standard blood pressure ( 120-130/70 -80 mm Hg ) , in delaying renal cystic progression in 558 patients with ADPKD , stages 1 and 2 chronic kidney disease , and hypertension ( age , 15-49 y ) .
-RESULTS	We found hepatomegaly to be common among patients with ADPKD .
-RESULTS	Cysts and parenchyma contributed to hepatomegaly .
-RESULTS	Cysts were more common and liver and cyst volumes were greater in women , increasing with age .
-RESULTS	Patients with advanced disease had a relative loss of liver parenchyma .
-RESULTS	We observed small abnormalities in results from liver laboratory tests , and that splenomegaly and hypersplenism were associated with PLD severity .
-RESULTS	Higher liver volumes were associated with a lower quality of life .
-CONCLUSIONS	Hepatomegaly is common even in early stage ADPKD and is not accounted for by cysts alone .
-CONCLUSIONS	Parenchymal volumes were larger , compared with liver volumes of patients without ADPKD or with those predicted by standardized equations , even among patients without cysts .
-CONCLUSIONS	The severity of PLD was associated with altered biochemical and hematologic features , as well as quality of life .
-CONCLUSIONS	ClinicalTrials.gov identifier : NCT00283686 .
-
-###25412095
-OBJECTIVE	Peripancreatic fluid collections ( PFCs ) have been adequately drained using multiple plastic stents placed in a single-step endoscopic ultrasound ( EUS ) procedure .
-OBJECTIVE	Recent reports have presented the usefulness of metal stents for this procedure ; however , there has been no prospective comparative study on their effectiveness and safety .
-OBJECTIVE	We conducted a prospective randomized study to compare multiple plastic stents with fully covered , self-expanding metal stents ( FCSEMSs ) for the drainage of PFCs .
-METHODS	Between January 2012 and May 2013 , patients with PFCs demonstrated by various modalities were enrolled in our study .
-METHODS	Patients were randomly assigned to receive either a FCSEMS or plastic stents for EUS-guided PFC drainage .
-METHODS	The procedure time , technical success rate , and adverse event rates of the PFCs were evaluated .
-RESULTS	50 patients ( 41 men ) were included and randomly assigned to either the FCSEMS group ( n = 25 ) or the plastic stent group ( n = 25 ) .
-RESULTS	The median procedure time with FCSEMS was significantly shorter than with plastic stents ( 15.0 min vs. 29.5 min , P < 0.01 ) .
-RESULTS	The technical success rate was 100 % for both groups .
-RESULTS	The clinical success rate was 20 out of 23 for FCSEMS and 20 out of 22 for plastic stents ( P = 0.97 ) .
-RESULTS	No adverse events occurred in the FCSEMS group , while adverse events occurred in two patients in the plastic stent group ( P = 0.16 ) .
-RESULTS	One recurrence was observed during follow-up in the FCSEMS group and none in the plastic stent group ( P = 0.15 ) .
-CONCLUSIONS	EUS-guided PFC drainage with FCSEMSs is comparable to such drainage with plastic stents in terms of technical feasibility , efficacy , and safety ; however , the use of FCSEMSs may also simplify and shorten the procedure .
-BACKGROUND	KCT0000766 ( https://cris.nih.go.kr ) .
-
-###24517298
-BACKGROUND	It is projected that in Australia there will be between 28 % and 48 % of palliative care patients living alone by the year 2031 .
-BACKGROUND	As such , it will become increasingly important to provide appropriate home-based care in order to support these patients to be cared for and die at home .
-OBJECTIVE	This study explored the experiences of community-based palliative care cancer patients who live alone without a caregiver and what psychosocial issues they face .
-METHODS	Face-to-face semistructured interviews were conducted with eight participants , and constant comparison was used for the analysis .
-RESULTS	Four main themes emerged : ( 1 ) loss of social networks ; ( 2 ) maintaining independence ; ( 3 ) balancing independence and the need for assistance ; and ( 4 ) planning for the end of life .
-CONCLUSIONS	Participants balanced independence with the need to accept help in order to maintain independence .
-CONCLUSIONS	Participants became more flexible about their preferred place of death .
-CONCLUSIONS	The practice implications for working with people close to death who are living alone are that supports and assistance may be needed to maintain social networks and also a sense of independence .
-
-###24886378
-BACKGROUND	The timely publication of findings in peer-reviewed journals is a primary goal of clinical research .
-BACKGROUND	In clinical trials , the processes leading to publication can be complex from choice and prioritization of analytic topics through to journal submission and revisions .
-BACKGROUND	As little literature exists on the publication process for multicenter trials , we describe the development , implementation , and effectiveness of such a process in a multicenter trial .
-METHODS	The Hepatitis C Antiviral Long-Term Treatment against Cirrhosis ( HALT-C ) trial included a data coordinating center ( DCC ) and clinical centers that recruited and followed more than 1,000 patients .
-METHODS	Publication guidelines were approved by the steering committee , and the publications committee monitored the publication process from selection of topics to publication .
-RESULTS	A total of 73 manuscripts were published in 23 peer-reviewed journals .
-RESULTS	When manuscripts were closely tracked , the median time for analyses and drafting of manuscripts was 8months .
-RESULTS	The median time for data analyses was 5months and the median time for manuscript drafting was 3months .
-RESULTS	The median time for publications committee review , submission , and journal acceptance was 7months , and the median time from analytic start to journal acceptance was 18months .
-CONCLUSIONS	Effective publication guidelines must be comprehensive , implemented early in a trial , and require active management by study investigators .
-CONCLUSIONS	Successful collaboration , such as in the HALT-C trial , can serve as a model for others involved in multidisciplinary and multicenter research programs .
-BACKGROUND	The HALT-C Trial was registered with clinicaltrials.gov ( NCT00006164 ) .
-
-###24801269
-BACKGROUND	Several evidences have supported the benefits of home blood pressure monitoring ( HBPM ) in improving hypertension awareness and control .
-BACKGROUND	However , little was known about the use of HBPM by hypertensive patients in primary care in China .
-METHODS	A cross-sectional questionnaire survey on HBPM use was conducted on 1915 hypertensive patients in Xinzhuang County Hospital in Shanghai , and the factors related to regular use of HBPM were also determined .
-RESULTS	Overall , 1011 of the 1915 participants engaged in using HBPM , among whom 786 individuals used HBPM more than once a month .
-RESULTS	Of the 1011 HBPM users , 25.42 % chose a mercury sphygmomanometer , 33.55 % used wrist-cuff electronic devices , and 46.5 % selected arm-cuff electronic devices .
-RESULTS	In addition , 73 % of HBPM users reported HBP readings to their general practitioners .
-RESULTS	Compared with the less frequent users , patients who used HBPM daily were likely to report their blood pressure ( BP ) values to the doctors depending on notebook or mechanical memory than on their own memories ( P < 0.001 ) .
-RESULTS	Moreover , patients with college education were 2.7 times more likely than those with middle school education or less to engage in frequent HBPM use ( odds ratio = 2.71 , 95 % confidence interval = 2.03-3 .61 ) .
-CONCLUSIONS	This local community survey showed that 40 % of hypertension patients used HBPM frequently in primary care in China .
-CONCLUSIONS	However , certain patients chose the improper BP monitoring device or questionable reporting methods .
-CONCLUSIONS	Therefore , the use of arm-cuff electric devices with multiple memory storage or a home BP telemonitoring system should be promoted by health education targeted at hypertensive patients .
-
-###24878589
-BACKGROUND	Use of rehabilitation technology , such as ( electro ) mechanical devices or robotics , could partly relieve the increasing strain on stroke rehabilitation caused by an increasing prevalence of stroke .
-BACKGROUND	Arm support ( AS ) training showed improvement of unsupported arm function in chronic stroke .
-OBJECTIVE	To examine the effect of weight-supported arm training combined with computerized exercises on arm function and capacity , compared with dose-matched conventional reach training in subacute stroke patients .
-METHODS	In a single-blind , multicenter , randomized controlled trial , 70 subacute stroke patients received 6 weeks of training with either an AS device combined with computerized exercises or dose-matched conventional training ( CON ) .
-METHODS	Arm function was evaluated pretraining and posttraining by Fugl-Meyer assessment ( FM ) , maximal reach distance , Stroke Upper Limb Capacity Scale ( SULCS ) , and arm pain via Visual Analogue Scale , in addition to perceived motivation by Intrinsic Motivation Inventory posttraining .
-RESULTS	FM and SULCS scores and reach distance improved significantly within both groups .
-RESULTS	These improvements and experienced pain did not differ between groups .
-RESULTS	The AS group reported higher interest/enjoyment during training than the CON group .
-CONCLUSIONS	AS training with computerized exercises is as effective as conventional therapy dedicated to the arm to improve arm function and activity in subacute stroke rehabilitation , when applied at the same dose .
-
-###25310118
-BACKGROUND	Rates of retention in care of HIV-positive pregnant women in care programs in Nigeria remain generally poor with rates around 40 % reported for specific programs .
-BACKGROUND	Poor quality of services in health facilities and long waiting times are among the critical factors militating against retention of these women in care .
-BACKGROUND	The aim of the interventions in this study is to assess whether a continuous quality improvement intervention using a Breakthrough Series approach in local district hospitals and primary health care clinics will lead to improved retention of HIV-positive women and mothers .
-METHODS	A cluster randomized controlled trial with 32 health facilities randomized to receive a continuous quality improvement/Breakthrough Series intervention or not .
-METHODS	The care protocol for HIV-infected pregnant women and mothers is the same in all sites .
-METHODS	The quality improvement intervention started 4 months before enrollment of individual HIV-infected pregnant women and initially focused on reducing waiting times for women and also ensuring that antiretroviral drugs are dispensed on the same day as clinic attendance .
-METHODS	The primary outcome measure is retention of HIV-positive mothers in care at 6 months postpartum .
-CONCLUSIONS	Results of this trial will inform whether quality improvement interventions are an effective means of improving retention in prevention of mother-to-child transmission of HIV programs and will also guide where health system interventions should focus to improve the quality of care for HIV-positive women .
-CONCLUSIONS	This will benefit policymakers and program managers as they seek to improve retention rates in HIV care programs .
-
-###24853809
-OBJECTIVE	Determine prevalence of diabetes , and describe use of blood glucose lowering ( BGL ) drugs and glycemic control in Norwegian nursing homes .
-METHODS	In this cross-sectional study we collected details of BGL drugs , capillary blood glucose measurements ( CBGM ) in the last four weeks and HbA1c measurements in the last 12 months from the medical records of patients with diabetes , within a population of 742 long-term care patients from 19 randomly selected nursing homes in Western Norway .
-METHODS	Descriptive statistics were applied , and Pearson 's chi-squared ( P0 .05 ) or non-overlapping 95 % confidence intervals were interpreted as significant effects .
-RESULTS	116 patients ( 16 % ) had diabetes , 100 of these gave informed consent and medical data were available .
-RESULTS	BGL treatment was as follows : ( 1 ) insulin only ( 32 % ) , ( 2 ) insulin and oral antidiabetics ( OADs ) ( 15 % ) , ( 3 ) OADs only ( 27 % ) and ( 4 ) no drugs ( 26 % ) .
-RESULTS	Patients with cognitive impairment were less likely to receive medical treatment ( P = 0.04 ) .
-RESULTS	CBGM and HbA1c measurements were performed for 73 % and 77 % of patients , respectively .
-RESULTS	Mean HbA1c was 7.3 % ( 57 mmol/mol ) , 46 % of patients had an HbA1c < 7.0 % ( 53 mmol/mol ) , and CBGM consistent with risk of hypoglycemia was found for 60 % of these patients .
-CONCLUSIONS	Prevalence of diabetes and BGL treatment in Norwegian nursing homes is comparable to other European countries .
-CONCLUSIONS	Although special care seems to be taken when choosing treatment for patients with cognitive impairment , there are signs of overtreatment in the population as a whole .
-CONCLUSIONS	The strict glycemic control unveiled may negatively affect these frail patients ' quality of life and increase the risk of early death .
-
-###24596360
-OBJECTIVE	To investigate whether the negative quality of life result of a large randomized exercise intervention study ( BREX ) was due to considerable spontaneous recovery after adjuvant treatments .
-METHODS	The change in QoL was studied in the control patients of the BREX study ( Group 1 ) and a group of similar follow-up patients that did not participate in any intervention study ( Group 2 ) .
-METHODS	QoL was measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 with the breast cancer module supplement 6 and 12 months after surgery .
-RESULTS	QoL improved in both groups between 6 and 12 months after surgery .
-RESULTS	The improvement was similar in both groups for global QoL and for most of the QoL sub-scales .
-CONCLUSIONS	No evidence was found to support the hypothesis that participation in an exercise intervention per se significantly improves QoL .
-CONCLUSIONS	Spontaneous improvement in QoL began during the first six months after the primary treatments , which might have confounded the results of the intervention of the BREX study .
-
-###24265330
-OBJECTIVE	Cranial electrotherapy stimulation ( CES ) is used as a treatment for depression and anxiety , and as an adjunctive intervention for pain management .
-OBJECTIVE	This prospective study investigated whether CES could decrease preoperative anxiety , the injection pain of rocuronium , postoperative pain and stress hormone levels .
-METHODS	Female patients undergoing thyroidectomy were randomly assigned to two groups , to receive either no pretreatment ( control group ) or CES pretreatment .
-METHODS	Anxiety score , withdrawal response on rocuronium injection , and pain scores at 1 , 4 , 12 and 24 h post surgery were evaluated .
-METHODS	Adrenocorticotrophic hormone ( ACTH ) , cortisol and glucose levels were measured .
-METHODS	Patients were blinded to the treatment condition .
-RESULTS	Fifty patients entered the study ( n = 25 per group ) .
-RESULTS	Anxiety score and withdrawal responses during rocuronium injection were significantly reduced in the CES group compared with the control group .
-RESULTS	Pain score was significantly lower in the CES group than in the control group , 1 h and 4 h post surgery .
-RESULTS	There were no significant differences in ACTH , cortisol and glucose levels .
-CONCLUSIONS	CES pretreatment appears to reduce the level of preoperative anxiety , injection pain of rocuronium and postoperative pain .
-CONCLUSIONS	However , CES pretreatment did not affect stress hormone responses .
-
-###24702577
-OBJECTIVE	To compare visual outcomes following photorefractive keratectomy ( PRK ) , PRK with mitomycin C ( MMC-PRK ) , and LASEK in moderate and high myopia in military personnel .
-METHODS	This prospective , randomized contralateral eye study included 167 patients 21 years or older with manifest spherical equivalent -5.99 1.40 diopters ( D ) ( range : -3.88 to -9.38 D ) randomized to either MMC-PRK or LASEK treatment in their dominant eye and conventional PRK without MMC in the fellow eye .
-METHODS	All procedures were performed using the LADARVision 4000 Excimer Laser System ( Alcon Surgical Inc. , Ft. Worth , TX ) .
-METHODS	High - and low-contrast visual acuities , manifest refraction , endothelial cell count , and corneal haze were evaluated up to 12 months postoperatively .
-RESULTS	At 12 months postoperatively , visual outcomes were comparable among the treatment groups .
-RESULTS	Corneal haze of any grade was less common in MMC-PRK compared to PRK at 1 month ( 21.4 % vs 31.0 % ; P < .01 ) and 3 months ( 12.8 % vs 35.9 % ; P = .03 ) postoperatively ; it was also less common in MMC-PRK compared to LASEK at 1 month ( 21.4 % vs 55.9 % ; P < .01 ) , 3 months ( 12.8 % vs 42.4 % ; P < .01 ) , and 6 months ( 12.2 % vs 36.4 % ; P = .03 ) postoperatively .
-RESULTS	Haze rate ( grade 0.5 or higher ) was comparable between LASEK and PRK .
-RESULTS	Clinically significant haze ( grade 2 or higher ) developed after PRK ( 4 eyes ) and LASEK ( 2 eyes ) , but not after MMC-PRK .
-CONCLUSIONS	MMC-PRK showed some benefits in minimizing corneal haze formation .
-CONCLUSIONS	One year after surgery , there was no discernible difference in the postoperative refractive outcomes among the three methods .
-
-###25669614
-OBJECTIVE	To establish the relative bioavailability ( rBA ) between two p.o. 5-mg levomethadone hydrochloride formulations , i.e. , L-Polamidon 5 mg tablets ( test ) vs. L-Polamidon solution for substitution ( reference ) .
-OBJECTIVE	To assess the safety and tolerability of both formulations .
-METHODS	A total of 33 healthy male subjects , aged 29 6 years ( BMI : 23.9 2.5 kg/m2 ) completed this single center , open-label , randomized , 2-period cross-over study with single dose administrations under fasting conditions and coadministration with naltrexone for safety reasons .
-METHODS	Administrations of both investigational products were separated by a washout period of at least 2 weeks , i.e. , 13 treatmentfree days .
-METHODS	The total dose for each subject was 2 x 5 mg resulting in 10 mg levomethadone hydrochloride .
-METHODS	For pharmacokinetic evaluation , blood samples were withdrawn until 72 hours postdose .
-METHODS	A validated non-stereoselective liquid chromatography-tandem mass spectroscopy method ( LC-MS/MS ) was applied for the determination of levomethadone in plasma .
-METHODS	The lower limit of quantitation was 0.100 ng/mL .
-METHODS	Adverse events were descriptively analyzed in the study population .
-RESULTS	The geometric means of the parameters related with the extent of total exposure of levomethadone , i.e. , AUC ( 0-tlast ) and AUC ( 0 - ) , were 244.422 ng x h/mL and 332.999 ng x h/mL for test and 246.837 ng x h/mL and 329.467 ngh/mL for reference , respectively .
-RESULTS	The geometric means of the peak exposure for levomethadone , i.e. , Cmax , were 8.923 ng/mL for test and 8.635 ng/mL for reference .
-RESULTS	The point estimates ( PEs ) of the Test/Reference ( T/R ) adjusted geometric mean ratios of AUC ( 0-last ) , AUC ( 0 - ) , and C ( max ) were 99.20 % , 101.42 % , and 104.11 % , respectively , and all of them showed 90 % - confidence intervals ( CIs ) within the range of 80.00 - 125.00 % as suggested by regulatory requirements for bioequivalence assessment In total , 21 subjects experienced 55 AEs during the study , the most frequently reported AE , i.e. , headache , accounted for 13 out of the total 55 AEs ( 23.6 % ) and no AEs of severe intensity were reported .
-CONCLUSIONS	Bioequivalence could be demonstrated in terms of rate and extent of absorption after administration of test and reference products under naltrexone protection .
-CONCLUSIONS	Concerning the safety evaluation , no negative implications on the possible use of the test formulation could be determined .
-
-###25545757
-BACKGROUND	Vincristine causes known side effects of peripheral sensory , motor , autonomic and cranial neuropathies .
-BACKGROUND	No preventive interventions are known .
-METHODS	We performed a randomized , placebo-controlled , double-blind trial of oral glutamic acid as a preventive agent in pediatric patients with cancer who would be receiving vincristine therapy for at least 9 consecutive weeks ( Stratum 1 = Wilms tumor and rhabdomyosarcoma ) or 4 consecutive weeks in conjunction with steroids ( Stratum 2 = Acute lymphoblastic leukemia and non-Hodgkin lymphoma ) .
-METHODS	At designated time points , a scored neurologic exam using the Modified Balis Pediatric Scale of Peripheral Neuropathies was performed to document neurologic toxicity .
-RESULTS	Between 2007 and 2012 , 250 patients were enrolled ( Stratum 1 = 50 , Stratum 2 = 200 ) .
-RESULTS	The glutamic acid treated group did not have a significantly lower percentage of neurotoxicity compared to placebo treated group either overall or within stratum or age subgroups .
-RESULTS	The only subgroup which was suggestive of treatment effect was for age .
-RESULTS	Patients 13 years or older showed a larger benefit in favor of glutamic acid ( P = 0.055 ) compared to patients less than 13 years ( P = 1.00 ) .
-RESULTS	Constipation was the most frequently reported ( 14 % ) Grade II or higher neurotoxicity .
-CONCLUSIONS	Vincristine-associated neurotoxicity in pediatric oncology remains a frequent complication of chemotherapy for multiple diagnoses with an approximate 30 % of patients affected .
-CONCLUSIONS	Glutamic acid is not effective for prevention in pre-adolescents .
-CONCLUSIONS	There is a suggestion of benefit in patients 13 years or older , but the study was not designed to provide adequate power to test the treatment effect within this age group alone .
-
-###25621943
-OBJECTIVE	To evaluate retinal sensitivity in patients with diabetic macular edema who received intravitreal aflibercept injection ( IAI ) or laser .
-METHODS	A substudy included 46 patients from DA VINCI ( a randomized , double-masked Phase 2 study ) receiving either laser , 0.5 mg IAI every 4 weeks , 2 mg IAI every 4 weeks , 2 mg IAI every 8 weeks after 3 monthly doses ( 2q8 ) , or 2 mg IAI as-needed after 3 monthly doses for 52 weeks .
-METHODS	Retinal sensitivity was measured in one ( central ) , five ( one central and four inner ) , and eight ( four inner and four outer ) optical coherence tomography subfields .
-RESULTS	Mean best-corrected visual acuity improvement in the subgroup at Week 52 was 3.3 letters with laser and ranged from 5.4 to 16.3 letters in the IAI groups .
-RESULTS	Retinal sensitivity of laser patients at Week 52 was comparable with baseline in the central optical coherence tomography subfield but decreased in the five and eight optical coherence tomography subfields .
-RESULTS	Compared with laser , retinal sensitivity significantly increased with IAI in the 2q8 and pooled IAI groups in the 5 and 8 optical coherence tomography subfields at Week 52 ( P < 0.05 ) .
-CONCLUSIONS	Intravitreal aflibercept injection improved best-corrected visual acuity and retinal sensitivity in this subgroup of patients .
-CONCLUSIONS	Laser may cause a deterioration of macular function that is not detectable with best-corrected visual acuity testing .
-
-###24812287
-OBJECTIVE	Prediction of radiographic progression ( RP ) in early rheumatoid arthritis ( eRA ) would be very useful for optimal choice among available therapies .
-OBJECTIVE	We evaluated a multi-biomarker disease activity ( MBDA ) score , based on 12 serum biomarkers as a baseline predictor for 1-year RP in eRA .
-METHODS	Baseline disease activity score based on erythrocyte sedimentation rate ( DAS28-ESR ) , disease activity score based on C-reactive protein ( DAS28-CRP ) , CRP , MBDA scores and DAS28-ESR at 3months were analysed for 235 patients with eRA from the Swedish Farmacotherapy ( SWEFOT ) clinical trial .
-METHODS	RP was defined as an increase in the Van der Heijde-modified Sharp score by more than five points over 1year .
-METHODS	Associations between baseline disease activity measures , the MBDA score , and 1-year RP were evaluated using univariate and multivariate logistic regression , adjusted for potential confounders .
-RESULTS	Among 235 patients with eRA , 5 had low and 29 moderate MBDA scores at baseline .
-RESULTS	None of the former and only one of the latter group ( 3.4 % ) had RP during 1year , while the proportion of patients with RP among those with high MBDA score was 20.9 % ( p = 0.021 ) .
-RESULTS	Among patients with low/moderate CRP , moderate DAS28-CRP or moderate DAS28-ESR at baseline , progression occurred in 14 % , 15 % , 14 % and 15 % , respectively .
-RESULTS	MBDA score was an independent predictor of RP as a continuous ( OR = 1.05 , 95 % CI 1.02 to 1.08 ) and dichotomised variable ( high versus low/moderate , OR = 3.86 , 95 % CI 1.04 to 14.26 ) .
-CONCLUSIONS	In patients with eRA , the MBDA score at baseline was a strong independent predictor of 1-year RP .
-CONCLUSIONS	These results suggest that when choosing initial treatment in eRA the MBDA test may be clinically useful to identify a subgroup of patients at low risk of RP .
-BACKGROUND	WHO database at the Karolinska Institute : CT20080004 ; and clinicaltrials.gov : NCT00764725 .
-
-###24622318
-BACKGROUND	Results of an exploratory phase 2 study showed that insulin degludec , a basal insulin with an action profile of longer than 42 h , provided similar glycaemic control when injected three times a week ( IDeg 3TW ) to once-daily insulin glargine ( IGlar OD ) .
-BACKGROUND	To provide further evidence , we did two phase 3 trials to compare the efficacy and safety of IDeg 3TW with IGlar OD in insulin-naive patients with type 2 diabetes .
-METHODS	In two 26 week , randomised , open-label , parallel group , non-inferiority trials IDeg was injected Monday , Wednesday , and Friday before breakfast ( IDeg 3TW ( AM ) ) in the AM trial ( 94 sites in seven countries ) or with the evening meal ( IDeg 3TW ( PM ) ) in the PM trial ( 89 sites in seven countries ) , and compared with IGlar OD .
-METHODS	Adults with type 2 diabetes ( HbA ( 1c ) 7.0-10 .0 % ; body-mass index 45 kg/m ( 2 ) ) were randomly allocated ( 1:1 ) without stratification by a central interactive response system to IDeg 3TW or IGlar OD .
-METHODS	Both groups continued taking metformin with or without dipeptidyl peptidase-4 inhibitors .
-METHODS	Insulin was titrated to achieve a prebreakfast self-monitored blood glucose ( SMBG ) concentration of between 3.9 and less than 5.0 mmol/L .
-METHODS	The primary outcome was non-inferiority of IDeg 3TW compared with IGlar OD , as assessed by change in HbA ( 1c ) from baseline to 26 weeks ( non-inferiority limit of 0.4 % ) by ANOVA in an intent-to-treat analysis ( full analysis set ) .
-METHODS	These trials are registered with ClinicalTrials.gov , numbers NCT01068678 and NCT01076647 .
-RESULTS	We recruited 460 patients for the AM trial ( IDeg 3TW ( AM ) , n = 230 ; IGlar OD , n = 230 ) and 467 patients for the PM trial ( IDeg 3TW ( PM ) , n = 233 ; IGlar OD , n = 234 ) .
-RESULTS	After 26 weeks , mean HbA decreased by 0.9 % ( IDeg 3TW ( AM ) ) and 1.3 % ( IGlar OD ) in the AM trial , and by 1.1 % ( IDeg 3TW ( PM ) ) and 1.4 % ( IGlar OD ) in the PM trial .
-RESULTS	Non-inferiority was not confirmed in either trial ( estimated treatment difference [ IDeg 3TW ( AM ) - IGlar OD ] 0.34 % , 95 % CI 0.18-0 .51 ; [ IDeg 3TW ( PM ) - IGlar OD ] 0.26 % , 0.11-0 .41 ) .
-RESULTS	Across the two trials , rates of confirmed hypoglycaemia ( SMBG < 3.1 mmol/L or severe [ needing assistance ] ) ranged from 1.0 to 1.6 episodes per patient-year and were similar for IDeg 3TW ( AM ) and IGlar OD ( estimated rate ratio [ ERR ] 1.04 , 95 % CI 0.69-1 .55 ) , but higher for IDeg 3TW ( PM ) than for IGlar OD ( ERR 1.58 , 1.03-2 .43 ) .
-RESULTS	The rate of nocturnal confirmed hypoglycaemia was higher for IDeg 3TW ( AM ) than for IGlar OD ( ERR 2.12 , 1.08-4 .16 ) ; we noted no significant difference between IDeg 3TW ( PM ) and IGlar OD ( ERR 0.60 , 0.21-1 .69 ) .
-CONCLUSIONS	The inferior glycaemic control and increased risk of hypoglycaemia with IDeg 3TW compared with IGlar OD do not support a three-times-weekly dosing regimen .
-BACKGROUND	Novo Nordisk .
-
-###24623027
-OBJECTIVE	To evaluate the efficacy of two office-based treatments designed to prevent deterioration in glycemic control in young adolescents with type 1 diabetes in a randomized clinical trial .
-OBJECTIVE	An individualized , more intensive family teamwork Coping skills program was compared with a diabetes Education treatment .
-METHODS	A baseline assessment was followed by four brief treatment sessions and immediate posttesting over the course of 1.5 years .
-METHODS	Families of 226 early adolescents ( ages 11-14 ) were randomized to receive either individualized coping skills education or diabetes education as adjunctive treatment to quarterly medical appointments .
-METHODS	Continued follow-up occurred at 3.5-month intervals for a long-term follow-up of up to 3 years .
-METHODS	A post hoc Usual Care group facilitated comparisons of glycemic control .
-RESULTS	Growth curve analysis showed that both treatment groups successfully prevented deterioration in adolescent disease care and simultaneously improved adolescent and parent quality of life that included indicators of more effective communication and reduced adherence barriers-without a concomitant increase in diabetes-related or general family conflict .
-RESULTS	However , contrary to expectation , the Education group was more efficacious than the Coping group in improvement of disease adherence and glycemic control over a 3-year follow-up .
-CONCLUSIONS	Low-intensity office-based quarterly treatment can maintain or improve disease care adherence in early adolescence when provided to adolescent/parent dyads .
-CONCLUSIONS	Better outcomes are achieved when treatment goals and techniques match the needs of the targeted population .
-
-###24338466
-BACKGROUND	In spinal anaesthesia for a Caesarean delivery , it is important to limit anaesthesia only at the surgical area , and to resolve fast motor block .
-BACKGROUND	We compared the intraoperative effectiveness , hemodynamic effects , anaesthetic recovery times and patients satisfaction after isobaric levobupivacaine ( L ) 0.25 % versus L0 .50 % spinal anaesthesia during elective Caesarean deliveries performed with the Stark technique .
-METHODS	In this double-blinded prospective study , seventy women undergoing elective caesarean delivery were randomized to receive either intrathecal 7.5 mg Levobupivacaine 0.25 % plus sufentanil 2.5 g ( Group L0 .25 ) , or intrathecal 7.5 mg L 0.50 % plus sufentanil 2.5 g ( GroupControl ) .
-METHODS	The onset time , duration of anaesthesia , analgesia and sensory and motor block and hemodynamic parameters were measured from the beginning of spinal anaesthesia until four hours after spinal anaesthesia ( T240 ) .
-RESULTS	Onset time , duration of anaesthesia and haemodynamic variations were similar in the two groups .
-RESULTS	No patients required general anesthesia to complete surgery .
-RESULTS	Motor block vanished faster in Group L0 .25 as compared with GroupControl ( p < .01 ) .
-RESULTS	The cephalad spread of the 0.50 % solution was higher than that of the 0.25 % solution : no patient in Group L0 .25 experienced paresthesia of the upper limbs vs 14 % in GroupControl ( p < .05 ) .
-RESULTS	In GroupControl anaesthesia reached the dermatome T1 in 15 % of cases .
-RESULTS	Maternal and surgeon satisfaction was good in every patient .
-CONCLUSIONS	Levobupivacaine 7.5 milligrams at 0.25 % may be used as a suitable alternative to L 0.50 % for spinal anaesthesia for caesarean deliveris with the Stark technique with good maternal satisfaction .
-CONCLUSIONS	In Group L0 .25 a lower appearance of nausea and hypotension were observed and motor and sensitive block developed and diminished faster while no clinically significant differences in hemodynamic behavior was observed between groups .
-
-###24864325
-OBJECTIVE	To compare functional and morphological outcomes of femtosecond laser clear corneal incision ( CCI ) versus manual CCI during cataract surgery .
-METHODS	Sixty eyes of 60 patients who underwent CCI during cataract surgery were randomized into two groups : femtosecond laser CCI ( 30 eyes ) and manual CCI ( 30 eyes ) .
-RESULTS	There were no significant between-group differences in uncorrected distance visual acuity , corrected distance visual acuity , surgically induced astigmatism , and corneal aberrations .
-RESULTS	Keratometric astigmatism was significantly lower in the femtosecond laser CCI group compared to the manual CCI group at 30 and 180 days ( P < .05 ) .
-RESULTS	Central endothelial cell count was significantly higher in the femtosecond laser CCI group compared to the manual CCI group at 7 and 30 days postoperatively ( P < .05 ) .
-RESULTS	A lower increase of corneal thickness at the incision site was observed at 30 and 180 days postoperatively in the femtosecond laser CCI group compared to the manual CCI group ( P < .05 ) .
-RESULTS	In addition , femtosecond laser CCI showed a better morphology ( lower percentage of endothelial and epithelial gaping and endothelial misalignment ) compared to manual CCI at different time points .
-RESULTS	Total phacoemulsification time was significantly lower in the femtosecond laser CCI group ( P < .05 ) .
-CONCLUSIONS	The femtosecond laser procedure was safe , efficient , and less damaging , as evidenced by lower central endothelial cell loss , lower increase of corneal thickness at the incision site , and better tunnel morphology compared to the manual technique .
-
-###24887252
-OBJECTIVE	The aim of this study was to compare the duration of postoperative analgesia and possible adverse effects produced by caudal bupivacaine 0.25 % at 1 ml/kg with or without 1.5 ug/kg of neostigmine in children undergoing unilateral herniotomy .
-METHODS	Sixty-six children aged 1-6 years , of ASA physical status classes I or II for elective unilateral herniotomy under general anaesthesia without premedication were studied .
-METHODS	The patients were randomly allocated into two groups of 33 each .
-METHODS	Group B received caudal analgesia with plain bupivacaine 0.25 % at 1 ml/kg alone , while group BN received caudal analgesia using a mixture of plain bupivacaine 0.25 % at 1 ml/kg and neostigmine 1.5 ug / kg .
-METHODS	Postoperatively , monitoring of pain scores and time to first analgesic request and , total dose of analgesics administered in the first 24 hours were recorded .
-RESULTS	All the patients participated throughout the study .
-RESULTS	There were no differences in the demographic characteristics ( age , weight , ASA status ) between the two groups .
-RESULTS	The mean duration of effective analgesia was significantly longer in group BN , 460 60.2 min .
-RESULTS	compared to group B , 286.4 47.8 mins , ( p < 0.001 ) .
-RESULTS	The analgesic requirement within the first 24 hours postoperatively was also significantly reduced in group BN , p < 0.001 .
-CONCLUSIONS	The study shows that the addition of low dose neostigmine to caudal isobaric bupivacaine significantly prolonged the time to first analgesic request and hence significantly reduced postoperative analgesic requirement .
-
-###25236187
-BACKGROUND	The American College of Surgeons Oncology Group Z0011 trial has been lauded as practice changing .
-BACKGROUND	We sought to identify its impact on breast cancer surgery in the community hospital setting .
-METHODS	A retrospective review was performed from 8 community hospitals identifying patients with invasive breast cancer meeting the Z0011 criteria .
-METHODS	The primary outcome measures were the rate of completion axillary lymph node dissection ( ALND ) and performance of intraoperative sentinel lymph node ( SLN ) analysis over time .
-RESULTS	A total of 1,125 lumpectomies with SLN biopsies were performed with 180 subjects meeting inclusion criteria .
-RESULTS	Performance of ALND ( P < .0001 ) and intraoperative SLN analysis ( P < .0001 ) declined during each time period .
-RESULTS	Patients more likely to undergo ALND included those with extracapsular extension ( odds ratio [ OR ] 12.8 , 95 % confidence interval [ CI ] 2.5 to 67.1 ) and those who underwent reoperative surgery ( OR 10.8 , 95 % CI 2.6 to 44.4 ) or intraoperative SLN analysis ( OR 5.1 , 95 % CI 1.2 to 21.9 ) .
-CONCLUSIONS	American College of Surgeons Oncology Group Z0011 trial has been rapidly practice changing in the community hospital setting .
-
-###25639879
-BACKGROUND	Indomethacin is a potent analgesic that , similar to other nonsteroidal anti-inflammatory drugs , is associated with serious dose-related adverse events .
-BACKGROUND	There is a need for newer nonsteroidal anti-inflammatory drug products with improved tolerability .
-BACKGROUND	Low-dose submicron indomethacin was developed using SoluMatrix Fine Particle Technology to enable treatment at lower doses than commercially available indomethacin drug products .
-BACKGROUND	This study evaluated the pharmacokinetics and safety of submicron indomethacin 20 and 40 mg compared with indomethacin 50-mg capsules .
-METHODS	This was a phase 1 , randomized , open-label , 4-period , 4-sequence , single-dose crossover study .
-METHODS	Forty healthy volunteers received low-dose submicron indomethacin 20 - or 40-mg capsules , or indomethacin 50-mg capsules under fasting or fed conditions .
-METHODS	Pharmacokinetic parameters and safety were assessed .
-RESULTS	Comparable fasting peak plasma levels ( mean standard deviation ) were demonstrated for submicron indomethacin 40 mg ( 2368.79 631.38 ng/ml ) and indomethacin 50 mg ( 2369.40 969.06 ng/ml ) .
-RESULTS	The overall systemic exposure ( geometric least squares mean ; 95 % CI ) was > 21 % lower for submicron indomethacin 40 mg ( 6007.71 ngh/mL ; 5585.73-6461 .58 ) compared with indomethacin 50 mg ( 7646.23 ngh/ml ; 7110.44-8222 .40 ) under fasting conditions .
-RESULTS	Food delayed the rate but did not affect the extent of indomethacin absorption from submicron indomethacin 40 mg .
-RESULTS	Submicron indomethacin 40 mg administration resulted in earlier time to peak plasma levels ( median 1.67 ; min-max 0.5-3 .5 hours ) under fasting conditions compared with indomethacin 50 mg ( 2.02 ; 0.5-5 .0 hours ) .
-RESULTS	Submicron indomethacin 20 and 40 mg were dose proportional and generally well tolerated .
-CONCLUSIONS	Compared with indomethacin 50 mg , submicron indomethacin 40 mg achieved similar peak plasma concentrations , lower systemic exposure , and a faster time to peak plasma concentration , indicating rapid absorption .
-CONCLUSIONS	The current formulation of low-dose submicron indomethacin has recently demonstrated efficacy in 2 phase 3 studies in patients with acute pain following bunionectomy and represents a new , low-dose treatment option for patients with acute pain .
-
-###25675651
-OBJECTIVE	To describe the profile of patients who participated in the Randomised Clinical Trial for Uniform Multidrug Therapy for Leprosy Patients in Brazil ( U-MDT/CT-BR ) and determine the level of satisfaction with a uniform therapy regimen , especially among paucibacillary patients .
-METHODS	This is a descriptive cross-sectional epidemiologic study nested in the wider U-MDT/CT-BR .
-METHODS	The study was conducted using a convenience sample composed of patients from the Dona Libnia Dermatology Centre in Fortaleza , Cear and from the Alfredo da Matta Foundation in Manaus , Amazonas in Brazil .
-METHODS	The absolute and relative frequencies of categorical variables and the median age were calculated .
-METHODS	Hypothesis testing was done using the Chi-squared and Mann-Whitney tests with a 0.05 level of significance .
-RESULTS	Of the 859 patients included in the clinical trial , 342 were interviewed .
-RESULTS	The majority of patients were male ( 58.2 % ) and multibacillary ( 78.3 % ) with a median age of 42 ( 7-65 ) years .
-RESULTS	Most of the interviewees had not completed primary education ( 48.0 % ) , earned an income below three times the minimum wage ( 53.8 % ) , were non-smokers ( 85.1 % ) , did not regularly consume alcohol ( 88.3 % ) , had not experienced any leprosy-related discrimination ( 69.2 % ) and showed a basic knowledge of the disease .
-RESULTS	With regards to paucibacillary patients , 87.8 % and 90.9 % of the PB U-MDT and PB R-MDT groups , respectively , indicated that they had not thought of defaulting treatment at any time .
-RESULTS	On a satisfaction scale of 1-5 ( with five as the highest score ) , 92.7 % of PB U-MDT and 100.0 % of PB R-MDT patients gave a mark between three and five .
-CONCLUSIONS	The data suggest that the introduction of clofazimine into the therapeutic regimen did not diminish the level of treatment satisfaction among PB patients .
-
-###24832787
-BACKGROUND	Circulating tumor cells ( CTCs ) have been shown to predict reduced survival outcomes in metastatic breast cancer .
-METHODS	CTCs were analyzed in 2026 patients with early breast cancer before adjuvant chemotherapy and in 1492 patients after chemotherapy using the CellSearch System .
-METHODS	After immuno-magnetic enrichment for cells expressing the epithelial-cell adhesion molecule , CTCs were defined as nucleated cells expressing cytokeratin and lacking CD45 .
-METHODS	The patients were followed for a median of 35 months ( range = 0-54 ) .
-METHODS	Kaplan-Meier analyses and the log-rank test were used for survival analyses .
-METHODS	All statistical tests were two-sided .
-RESULTS	Before chemotherapy , CTCs were detected in 21.5 % of patients ( n = 435 of 2026 ) , with 19.6 % ( n = 136 of 692 ) of node-negative and 22.4 % ( n = 299 of 1334 ) of node-positive patients showing CTCs ( P < .001 ) .
-RESULTS	No association was found with tumor size , grading , or hormone receptor status .
-RESULTS	After chemotherapy , 22.1 % of patients ( n = 330 of 1493 ) were CTC positive .
-RESULTS	The presence of CTCs was associated with poor disease-free survival ( DFS ; P < .0001 ) , distant DFS ( P < .001 ) , breast cancer-specific survival ( P = .008 ) , and overall survival ( OS ; P = .0002 ) .
-RESULTS	CTCs were confirmed as independent prognostic markers in multivariable analysis for DFS ( hazard ratio [ HR ] = 2.11 ; 95 % confidence interval [ CI ] = 1.49 to 2.99 ; P < .0001 ) and OS ( HR = 2.18 ; 95 % CI = 1.32 to 3.59 ; P = .002 ) .
-RESULTS	The prognosis was worst in patients with at least five CTCs per 30 mL blood ( DFS : HR = 4.51 , 95 % CI = 2.59 to 7.86 ; OS : HR = 3.60 , 95 % CI = 1.56 to 8.45 ) .
-RESULTS	The presence of persisting CTCs after chemotherapy showed a negative influence on DFS ( HR = 1.12 ; 95 % CI = 1.02 to 1.25 ; P = .02 ) and on OS ( HR = 1.16 ; 95 % CI = 0.99 to 1.37 ; P = .06 ) CONCLUSIONS : These results suggest the independent prognostic relevance of CTCs both before and after adjuvant chemotherapy in a large prospective trial of patients with primary breast cancer .
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-###24462043
-OBJECTIVE	Reduction of cardiovascular risk with high consumption of fish in diet is still a matter of debate , and concerns about heavy metal contamination have limited consumption of oily fish .
-OBJECTIVE	We aimed to evaluate the effect of regular ingestion of white fish on cardiovascular risk factors in patients with metabolic syndrome .
-RESULTS	Multicenter randomized crossover clinical trial including 273 individuals with metabolic syndrome .
-RESULTS	An 8-week only-one dietary intervention : 100 g/d of white fish ( Namibia hake ) with advice on a healthy diet , compared with no fish or seafood with advice on a healthy diet .
-RESULTS	Outcomes were lipid profile , individual components of the metabolic syndrome , serum insulin concentrations , homeostasis model of insulin resistance , serum C-reactive protein and serum fatty acid levels .
-RESULTS	We found a significant lowering effect of the intervention with white fish on waist circumference ( P < 0.001 ) and diastolic blood pressure ( P = 0.014 ) .
-RESULTS	A significant lowering effect was also shown after the dietary intervention with fish on serum LDL concentrations ( P = 0.048 ) , whereas no significant effects were found on serum HDL or triglyceride concentrations .
-RESULTS	A significant rise ( P < 0.001 ) in serum EPA and DHA fatty acids was observed following white fish consumption .
-RESULTS	Overall adherence to the intervention was good and no adverse events were found .
-CONCLUSIONS	In individuals with metabolic syndrome , regular consumption of hake reduces LDL cholesterol concentrations , waist circumference and blood pressure components of the metabolic syndrome .
-BACKGROUND	White Fish for Cardiovascular Risk Factors in Patients with Metabolic Syndrome Study , Registered under ClinicalTrials.gov Identifier : NCT01758601 .
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-###24365274
-BACKGROUND	Despite the popularity of hypnotherapy for smoking cessation , the efficacy of this method is unclear .
-BACKGROUND	We aimed to investigate the efficacy of a single-session of group hypnotherapy for smoking cessation compared to relaxation in Swiss adult smokers .
-METHODS	This was a cluster-randomised , parallel-group , controlled trial .
-METHODS	A single session of hypnosis or relaxation for smoking cessation was delivered to groups of smokers ( median size = 11 ) .
-METHODS	Participants were 223 smokers consuming 5 cigarettes per day , willing to quit and not using cessation aids ( 47.1 % females , M = 37.5 years [ SD = 11.8 ] , 86.1 % Swiss ) .
-METHODS	Nicotine withdrawal , smoking abstinence self-efficacy , and adverse reactions were assessed at a 2-week follow-up .
-METHODS	The main outcome , self-reported 30-day point prevalence of smoking abstinence , was assessed at a 6-month follow up .
-METHODS	Abstinence was validated through salivary analysis .
-METHODS	Secondary outcomes included number of cigarettes smoked per day , smoking abstinence self-efficacy , and nicotine withdrawal .
-RESULTS	At the 6-month follow up , 14.7 % in the hypnosis group and 17.8 % in the relaxation group were abstinent .
-RESULTS	The intervention had no effect on smoking status ( p = .73 ) or on the number of cigarettes smoked per day ( p = .56 ) .
-RESULTS	Smoking abstinence self-efficacy did not differ between the interventions ( p = .14 ) at the 2-week follow-up , but non-smokers in the hypnosis group experienced reduced withdrawal ( p = .02 ) .
-RESULTS	Both interventions produced few adverse reactions ( p = .81 ) .
-CONCLUSIONS	A single session of group hypnotherapy does not appear to be more effective for smoking cessation than a group relaxation session .
-BACKGROUND	Current Controlled Trials ISRCTN72839675 .
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-###25323219
-OBJECTIVE	A review on headache and insomnia revealed that insomnia is a risk factor for increased headache frequency and headache intensity in migraineurs .
-OBJECTIVE	The authors designed a randomized , double blind , placebo-controlled , parallel-group , pilot study in which migraineurs who also had insomnia were enrolled , to test this observation .
-METHODS	In the study , the authors treated 79 subjects with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia for 6 weeks with 3 mg eszopiclone ( Lunesta ( ) ) or placebo at bedtime .
-METHODS	The treatment was preceded by a 2-week baseline period and followed by a 2-week run-out period .
-RESULTS	Of the 79 subjects treated , 75 were evaluable , 35 in the eszopiclone group , and 40 in the placebo group .
-RESULTS	At baseline , the groups were comparable except for sleep latency .
-RESULTS	Of the three remaining sleep variables , total sleep time , nighttime awakenings , and sleep quality , the number of nighttime awakenings during the 6-week treatment period was significantly lower in the eszopiclone group than in the placebo group ( P = 0.03 ) .
-RESULTS	Of the three daytime variables , alertness , fatigue , and functioning , this was also the case for fatigue ( P = 005 ) .
-RESULTS	The headache variables , frequency , duration , and intensity , did not show a difference from placebo during the 6-week treatment period .
-CONCLUSIONS	The study did not meet primary endpoint , that is , the difference in total sleep time during the 6-week treatment period between eszopiclone and placebo was less than 40 minutes .
-CONCLUSIONS	Therefore , it failed to answer the question as to whether insomnia is , indeed , a risk factor for increased headache frequency and headache intensity in migraineurs .
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-###24465617
-BACKGROUND	The MAINTAIN study is an on-going RCT comparing high-dose micronutrient and anti-oxidant supplementation versus recommended daily allowance ( RDA ) vitamins in slowing HIV immune deficiency progression in ART-nave people with HIV infection .
-OBJECTIVE	We planned analysis of the first 127 participants to determine the baseline prevalence of serum micronutrient deficiencies and correlates , as well as tolerance and adherence to study interventions .
-METHODS	Participants receive eight capsules twice daily of 1 ) high-dose or 2 ) RDA supplements for two years and are followed-up quarterly for measures of immune deficiency progression , safety and tolerability .
-METHODS	Regression analysis was used to identify correlates of micronutrient levels at baseline .
-METHODS	Adherence was measured by residual pill count , self-report using the General Treatment Scale ( GTS ) and short-term recall HIV Adherence Treatment Scale ( HATS ) .
-RESULTS	Prior micronutrient supplementation ( within 30 days ) was 27 % at screening and 10 % of study population , and was not correlated with baseline micronutrient levels .
-RESULTS	Low levels were frequent for carotene ( 24 % < 1 nmol/L ) , vitamin D ( 24 % < 40 nmol/L ) and serum folate ( 20 % < 15 nmol/L ) .
-RESULTS	The proportion with B12 deficiency ( < 133 pmol/L ) was 2.4 % .
-RESULTS	Lower baseline levels of B12 correlated lower baseline CD4 count ( r = 0.21 , p = 0.02 ) with a 21 pmol/L reduction in B12 per 100 cells/L CD4 .
-RESULTS	Vitamin D levels were higher in men ( p < 0.001 ) .
-RESULTS	After a median follow-up of 1.63 years , there were 19 ( 15 % ) early withdrawals from the study treatment .
-RESULTS	Mean treatment adherence using pill count was 88 % .
-RESULTS	Subjective adherence by the GTS was 81 % and was moderately but significantly correlated with pill count ( r = 0.29 , p < 0.001 ) .
-RESULTS	Adherence based on short-term recall ( HATS ) was > 80 % in 75 % of participants .
-CONCLUSIONS	Micronutrient levels in asymptomatic HIV + persons are in keeping with population norms , but micronutrient deficiencies are frequent .
-CONCLUSIONS	Adherence levels are high , and will permit a valid evaluation of treatment effects .
-BACKGROUND	ClinicalTrials.gov NCT00798772 .
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-###24800381
-BACKGROUND	Gestational diabetes mellitus ( GDM ) increases risks for type 2 diabetes and cardiovascular diseases .
-BACKGROUND	Low glycaemic index ( GI ) diets improve cardio-metabolic outcomes in insulin-resistant individuals .
-BACKGROUND	We examined the feasibility of lowering GI through GI-based-education among Asian post-GDM women .
-METHODS	A 3-month investigation was carried out on 60 Malaysian women with a mean age of 31.0 + / - 4.5 years and a history of GDM .
-METHODS	Subjects were randomised into two groups : LGIE and CHDR .
-METHODS	The CHDR group received conventional healthy dietary recommendations only .
-METHODS	The LGIE group received GI based-education in addition to conventional healthy dietary recommendations .
-METHODS	At baseline and after 3-months , dietary intake of energy and macronutrient intakes including GI diet and glycaemic load was assessed using 3-day food records .
-METHODS	Diabetes-Diet and GI-concept scores and physical activity levels were assessed using a questionnaire .
-METHODS	Adherence to dietary instructions was measured at the end of 3 months .
-RESULTS	At the end of 3 months , the LGIE group had significant reductions in energy intake ( 241.7 + / - 522.4 Kcal , P = 0.037 , ES = 0.463 ) , total carbohydrate ( 48.7 + / - 83.5 g , P = 0.010 , ES = 0.583 ) , GI ( 3.9 + / - 7.1 , P = 0.017 , ES = 0.549 ) and GL ( 39.0 + / - 55.3 , P = 0.003 , ES = 0.705 ) and significant increases in protein ( 3.7 + / - 5.4 g , 0.003 , ES = 0.685 ) and diet fibre ( 4.6 + / - 7.3 g , P = 0.06 ) .
-RESULTS	The CHDR group had a significant reduction in fat only ( 5.7 + / - 9.4 g , P = 0.006 , ES = 0.606 ) .
-RESULTS	There was a 30 % increase in GI-concept scores in the LGIE group ( p < 0.001 ) .
-RESULTS	Changes in GI-concept scores correlated significantly to the reduction in dietary GI ( r = -0.642 , P = 0.045 ) .
-RESULTS	Dietary adherence was comparable in both groups .
-CONCLUSIONS	GI-education improves GI-concept knowledge and helps lower dietary glycaemic index among women with a history of GDM .
-
-###24428857
-OBJECTIVE	To determine whether single-dose tranexamic acid given intravenously immediately before surgery for presumed advanced ovarian cancer reduces perioperative blood loss and blood transfusions .
-METHODS	A randomized double-blind , placebo-controlled multicenter study .
-METHODS	Two university hospitals and two central hospitals in the southeast health region of Sweden .
-METHODS	One hundred women with presumed advanced ovarian cancer scheduled for radical debulking surgery between March 2008 and May 2012 who complied with inclusion/exclusion criteria were randomized ; 50 were allocated to receive tranexamic acid and 50 to receive placebo .
-METHODS	Analysis was performed according to intention-to-treat principles .
-METHODS	The volume of tranexamic acid ( 15mg/kg body weight , 100mg/mL tranexamic acid ) or the same volume of placebo ( 0.9 % NaCl ) was added to a 100-mL saline solution plastic bag .
-METHODS	The study medication was given immediately before the start of surgery .
-METHODS	Data were analyzed by means of non-parametric statistics and multivariate models adjusted for confounding factors .
-METHODS	Blood loss and red blood cell transfusions .
-RESULTS	The total blood loss volume and transfusion rate were significantly lower in the tranexamic acid group compared with the placebo group .
-RESULTS	Median total blood loss was 520 and 730mL , respectively ( p = 0.03 ) .
-RESULTS	Fifteen ( 30 % ) and 22 ( 44 % ) , respectively received transfusions ( odds ratio 0.44 ; upper 95 % CI 0.97 ; p = 0.02 ) .
-CONCLUSIONS	A single dose of tranexamic acid given immediately before surgery reduces blood loss and transfusion rates significantly in advanced ovarian cancer surgery .
-CONCLUSIONS	Tranexamic acid may be recommended as standard prophylactic treatment in advanced ovarian cancer surgery .
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-###25976288
-OBJECTIVE	To determine the effectiveness of a physical activity intervention for smoking cessation during pregnancy .
-METHODS	Parallel group , randomised controlled , multicentre trial .
-METHODS	13 hospitals in England , April 2009 to January 2014 .
-METHODS	789 pregnant smokers , aged 16-50 years and at 10-24 weeks ' gestation , who smoked at least one cigarette daily and were prepared to quit smoking one week after enrollment were randomised ( 1:1 ) ; 785 were included in the intention to treat analyses , with 392 assigned to the physical activity group .
-METHODS	Interventions began one week before a target quit date .
-METHODS	Participants were randomised to six weekly sessions of behavioural support for smoking cessation ( control ) or to this support plus 14 sessions combining supervised treadmill exercise and physical activity consultations .
-METHODS	The primary outcome was continuous smoking abstinence from the target quit date until end of pregnancy , validated by exhaled carbon monoxide or salivary cotinine levels .
-METHODS	To assess adherence , levels of moderate-vigorous intensity physical activity were self reported and in a 11.5 % ( n = 90 ) random subsample of participants , physical activity was objectively measured by an accelerometer .
-RESULTS	No significant difference was found in rates of smoking abstinence at end of pregnancy between the physical activity and control groups ( 8 % v 6 % ; odds ratio 1.21 , 95 % confidence interval 0.70 to 2.10 ) .
-RESULTS	For the physical activity group compared with the control group , there was a 40 % ( 95 % confidence interval 13 % to 73 % ) , 34 % ( 6 % to 69 % ) , and 46 % ( 12 % to 91 % ) greater increase in self reported minutes carrying out physical activity per week from baseline to one week , four weeks , and six weeks post-quit day , respectively .
-RESULTS	According to the accelerometer data there was no significant difference in physical activity levels between the groups .
-RESULTS	Participants attended a median of four treatment sessions in the intervention group and three in the control group .
-RESULTS	Adverse events and birth outcomes were similar between the two groups , except for significantly more caesarean births in the control group than in the physical activity group ( 29 % v 21 % , P = 0.023 ) .
-CONCLUSIONS	Adding a physical activity intervention to behavioural smoking cessation support for pregnant women did not increase cessation rates at end of pregnancy .
-CONCLUSIONS	During pregnancy , physical activity is not recommended for smoking cessation but remains indicated for general health benefits .
-CONCLUSIONS	Trial registration Current Controlled Trials ISRCTN48600346 .
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-###26179201
-BACKGROUND	Cisplatin and gemcitabine is the standard first-line chemotherapy regimen for patients with advanced biliary tract cancer ; expression of VEGF and its receptors is associated with adverse outcomes .
-BACKGROUND	We aimed to assess the effect of the addition of cediranib ( an oral inhibitor of VEGF receptor 1 , 2 , and 3 ) to cisplatin and gemcitabine on progression-free survival .
-METHODS	In this multicentre , placebo-controlled , randomised phase 2 study , we recruited patients aged 18 years or older with histologically confirmed or cytologically confirmed advanced biliary tract cancer from hepatobiliary oncology referral centres in the UK .
-METHODS	Patients were eligible if they had an ECOG performance status of 0-1 and an estimated life expectancy of longer than 3 months .
-METHODS	Patients were given first-line cisplatin and gemcitabine chemotherapy ( 25 mg/m ( 2 ) cisplatin and 1000 mg/m ( 2 ) gemcitabine [ on days 1 and 8 every 21 days , for up to eight cycles ] ) with either 20 mg oral cediranib or placebo once a day until disease progression .
-METHODS	We randomly assigned patients ( 1:1 ) with a minimisation algorithm , incorporating the stratification factors : extent of disease , primary disease site , previous treatment , ECOG performance status , and centre .
-METHODS	The primary endpoint was progression-free survival in the intention-to-treat population .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT00939848 , and was closed on Sept 30 , 2014 ; results of the final analysis for the primary endpoint are presented .
-RESULTS	Between April 5 , 2011 , and Sept 28 , 2012 , we enrolled 124 patients ( 62 in each group ) .
-RESULTS	With a median follow-up of 122 months ( IQR 73-185 ) , median progression-free survival was 80 months ( 95 % CI 65-93 ) in the cediranib group and 74 months ( 57-85 ) in the placebo group ( HR 093 , 80 % CI 074-119 , 95 % CI 065-135 ; p = 072 ) .
-RESULTS	Patients who received cediranib had more grade 3-4 toxic effects than did patients who received placebo : hypertension ( 23 [ 37 % ] vs 13 [ 21 % ] ; p = 005 ) , diarrhoea ( eight [ 13 % ] vs two [ 3 % ] ; p = 005 ) ; platelet count decreased ( ten [ 16 % ] vs four [ 6 % ] ; p = 009 ) , white blood cell decreased ( 15 [ 24 % ] vs seven [ 11 % ] ; p = 006 ) and fatigue ( 16 [ 24 % ] vs seven [ 11 % ] ; p = 004 ) .
-CONCLUSIONS	Cediranib did not improve the progression-free survival of patients with advanced biliary tract cancer in combination with cisplatin and gemcitabine , which remains the standard of care .
-CONCLUSIONS	Although patients in the cediranib group had more adverse events , we recorded no unexpected toxic effects .
-CONCLUSIONS	The role of VEGF inhibition in addition to chemotherapy for patients with advanced biliary tract cancer remains investigational .
-BACKGROUND	Cancer Research UK and AstraZeneca Pharmaceuticals .
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-###25385878
-BACKGROUND	In the United Kingdom , licensed nicotine-containing products can be recommended to reduce the harm associated with smoking .
-BACKGROUND	Many smokers find currently available nicotine replacement products unsatisfactory .
-BACKGROUND	The arterial and venous pharmacokinetics ( PK ) of nicotine delivered via a novel inhaler device were determined .
-METHODS	Results are reported for Parts A ( N = 18 ) and C ( N = 18 ) of a 4-part ( A-D ) Phase I study .
-METHODS	Participants ( 18-55 years , 10 cigarettes/day , smoking within 1 hr of waking , expired carbon monoxide > 10 ppm on screening ) orally inhaled 2 single doses of nicotine ( 2 of 3 dose levels [ 0.22 , 0.45 , and 0.67 mg ] ) ( Part A ) and repeated hourly doses of 0.67 mg nicotine for 12 hr ( Part C ) , via the novel device .
-METHODS	Arterial and venous PK and tolerability were assessed .
-RESULTS	In Part A , mean arterial plasma nicotine concentrations at 2 min after the start of inhalation were 1.10 , 2.06 , and 2.59 ng/mL for the 0.22 , 0.45 , and 0.67 mg doses , respectively .
-RESULTS	Mean maximum arterial plasma nicotine concentrations ( C ( max ) ) were 2.11 , 3.73 , and 4.38 ng/mL and mean times to C ( max ) were 10.2 , 7.3 , and 6.5 min after the start of inhalation for the 0.22 , 0.45 , and 0.67 mg doses , respectively .
-RESULTS	In Part C , the mean pre - and postdose venous plasma nicotine concentration increased steadily and fluctuated in the range 8-10 mg/mL after 9 hr .
-RESULTS	The novel device was well tolerated ; most adverse events were mild .
-CONCLUSIONS	The novel inhaler device delivers nicotine rapidly into the systemic circulation and offers a viable alternative to cigarettes for those finding it difficult to quit the behavioral and sensorial aspects of smoking .
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-###24821196
-BACKGROUND	The N-methyl-D-aspartate glutamate receptor antagonist ketamine , delivered via an intravenous route , has shown rapid antidepressant effects in patients with treatment-resistant depression .
-BACKGROUND	The current study was designed to test the safety , tolerability , and efficacy of intranasal ketamine in patients with depression who had failed at least one prior antidepressant trial .
-METHODS	In a randomized , double-blind , crossover study , 20 patients with major depression were randomly assigned , and 18 completed 2 treatment days with intranasal ketamine hydrochloride ( 50 mg ) or saline solution .
-METHODS	The primary efficacy outcome measure was change in depression severity 24 hours after ketamine or placebo , measured using the Montgomery-sberg Depression Rating Scale .
-METHODS	Secondary outcomes included persistence of benefit , changes in self-reports of depression , changes in anxiety , and proportion of responders .
-METHODS	Potential psychotomimetic , dissociative , hemodynamic , and general adverse effects associated with ketamine were also measured .
-RESULTS	Patients showed significant improvement in depressive symptoms at 24 hours after ketamine compared to placebo ( t = 4.39 , p < .001 ; estimated mean Montgomery-sberg Depression Rating Scale score difference of 7.6 3.7 ; 95 % confidence interval , 3.9-11 .3 ) .
-RESULTS	Response criteria were met by 8 of 18 patients ( 44 % ) 24 hours after ketamine administration compared with 1 of 18 ( 6 % ) after placebo ( p = .033 ) .
-RESULTS	Intranasal ketamine was well tolerated with minimal psychotomimetic or dissociative effects and was not associated with clinically significant changes in hemodynamic parameters .
-CONCLUSIONS	This study provides the first controlled evidence for the rapid antidepressant effects of intranasal ketamine .
-CONCLUSIONS	Treatment was associated with minimal adverse effects .
-CONCLUSIONS	If replicated , these findings may lead to novel approaches to the pharmacologic treatment of patients with major depression .
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-###24902920
-BACKGROUND	High blood pressure is an important public health concern because it is highly prevalent and a risk factor for adverse health outcomes , including coronary heart disease , stroke , decompensated heart failure , chronic kidney disease , and decline in cognitive function .
-BACKGROUND	Observational studies show a progressive increase in risk associated with blood pressure above 115/75 mm Hg .
-BACKGROUND	Prior research has shown that reducing elevated systolic blood pressure lowers the risk of subsequent clinical complications from cardiovascular disease .
-BACKGROUND	However , the optimal systolic blood pressure to reduce blood pressure-related adverse outcomes is unclear , and the benefit of treating to a level of systolic blood pressure well below 140 mm Hg has not been proven in a large , definitive clinical trial .
-OBJECTIVE	To describe the design considerations of the Systolic Blood Pressure Intervention Trial ( SPRINT ) and the baseline characteristics of trial participants .
-METHODS	The Systolic Blood Pressure Intervention Trial is a multicenter , randomized , controlled trial that compares two strategies for treating systolic blood pressure : one targets the standard target of < 140 mm Hg , and the other targets a more intensive target of < 120 mm Hg .
-METHODS	Enrollment focused on volunteers of age 50 years ( no upper limit ) with an average baseline systolic blood pressure 130 mm Hg and evidence of cardiovascular disease , chronic kidney disease , 10-year Framingham cardiovascular disease risk score 15 % , or age 75 years .
-METHODS	The Systolic Blood Pressure Intervention Trial recruitment also targeted three pre-specified subgroups : participants with chronic kidney disease ( estimated glomerular filtration rate < 60 mL/min/1 .73 m ( 2 ) ) , participants with a history of cardiovascular disease , and participants 75 years of age or older .
-METHODS	The primary outcome is first the occurrence of a myocardial infarction ( MI ) , acute coronary syndrome , stroke , heart failure , or cardiovascular disease death .
-METHODS	Secondary outcomes include all-cause mortality , decline in kidney function or development of end-stage renal disease , incident dementia , decline in cognitive function , and small-vessel cerebral ischemic disease .
-RESULTS	Between 8 November 2010 and 15 March 2013 , Systolic Blood Pressure Intervention Trial recruited and randomized 9361 people at 102 clinics , including 3331 women , 2648 with chronic kidney disease , 1877 with a history of cardiovascular disease , 3962 minorities , and 2636 75 years of age .
-CONCLUSIONS	Although the overall recruitment target was met , the numbers recruited in the high-risk subgroups were lower than planned .
-CONCLUSIONS	The Systolic Blood Pressure Intervention Trial will provide important information on the risks and benefits of intensive blood pressure treatment targets in a diverse sample of high-risk participants , including those with prior cardiovascular disease , chronic kidney disease , and those aged 75 years .
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-###25046950
-OBJECTIVE	To observe the clinical effect of Shen-reinforcing and menstrual cycle-regulating therapy ( SRMCRT ) combined with Western medicine ( WM ) in treating decline in ovarian reserve ( DOR ) .
-METHODS	Totally 78 patients with DOR were assigned to the traditional Chinese medicine combined WM group ( abbreviated as IM group , 40 cases ) , and the WM group ( 38 cases ) according to random digit table method .
-METHODS	Patients in the WM group were treated with hormone replacement therapy , while those in the IM group additionally received SRMCRT .
-METHODS	The therapeutic course for all was 3 consecutive months .
-METHODS	The therapeutic efficacy was compared between the two groups .
-METHODS	The serum levels of follicle stimulating hormone ( FSH ) , FSH/luteinizing hormone ( LH ) , and estradiol ( E2 ) , as well as the development of sinus follicles were compared between before and after treatment in the two groups .
-RESULTS	The therapeutic effective rate was 92.5 % in the IM group , higher than that of the WM group ( 73.68 % , P < 0.05 ) .
-RESULTS	The serum levels of FSH , FSH/LH , and E2 decreased ( P < 0.05 ) and the number of the sinus follicle increased ( P < 0.05 ) in the two groups after treatment .
-RESULTS	Besides , IM was superior in decreasing serum levels of FSH and FSH/LH , and increasing the number of the sinus follicle ( P < 0.05 ) .
-CONCLUSIONS	SRMCRT was an effective method for treating ROD .
-CONCLUSIONS	IM was superior in decreasing serum levels of FSH and FSH/LH , and increasing the number of the sinus follicle .
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-###25213687
-BACKGROUND	Animal studies suggest that the renin-angiotensin-aldosterone system is involved in neurocognitive function and the response to antihypertensive therapy .
-BACKGROUND	We investigated the impact of circulating aldosterone and renin activity on cognition and cerebral hemodynamics at baseline and after antihypertensive therapy for 1 year .
-METHODS	Participants were older adults ( n = 47 ; mean age = 71 years ) enrolled in a clinical trial .
-METHODS	Routine antihypertensive medications were replaced with the study regimen to achieve a blood pressure < 140/90 mm Hg .
-METHODS	Executive function , memory , cerebral hemodynamics ( blood flow velocity ) , CO2 vasoreactivity ( measured using transcranial Doppler ultrasonography ) , plasma renin activity , and aldosterone were measured at baseline and at 6 and 12 months after the initiation of treatment .
-RESULTS	At baseline , higher levels of circulating aldosterone were associated with lower blood flow velocity ( = -0.02 ; P = 0.03 ) , lower CO2 vasoreactivity ( = -0.11 ; P = 0.007 ) , and decreased autoregulation abilities ( = -0.09 ; P = 0.01 ) .
-RESULTS	Those with higher levels of aldosterone at baseline demonstrated the greatest improvement in executive function ( P = 0.014 for the aldosterone effect ) and in CO2 vasoreactivity ( P = 0.026 for the aldosterone effect ) after 12 months of lowering blood pressure ( < 140/90 mm Hg ) .
-RESULTS	Plasma renin activity was not associated with any of the measures .
-CONCLUSIONS	Higher levels of aldosterone may be associated with decreased cerebrovascular function in hypertension .
-CONCLUSIONS	Those with higher aldosterone levels may benefit the most from lowering blood pressure .
-CONCLUSIONS	The role of aldosterone in brain health warrants further investigation in a larger trial .
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-###25509734
-OBJECTIVE	To compare the difference in the clinical efficacy on cervical spondylosis between acupuncture at three lines of cervical Jiaji ( EX-B 2 ) and oral administration of jingfukang granules .
-METHODS	Three hundred cases of cervical spondylosis were divided into an acupuncture group and a medication group , 150 cases in each one .
-METHODS	In the acupuncture group , according to the different types of cervical spondylosis , acupuncture was applied at three lines of cervical Jiaji ( EX-B 2 ) , once a day .
-METHODS	In the medication group , jingfukang granules were prescribed for oral administration , one bag each time , three times a day .
-METHODS	The treatment of ten days made one session in the two groups and two sessions were required totally .
-METHODS	Before and after two sessions of treatment , the clinical assessment scale for cervical spondylosis ( CASCS ) was adopted to evaluate the score of subjective symptoms , clinical physical signs and adaptability as well as the total score in the patients of the two groups and the efficacy was compared .
-RESULTS	The patients ' symptoms and physical signs were alleviated , the adaptability was improved and the score of each item and the total score were increased in the two groups after treatment ( all P < 0.01 ) .
-RESULTS	The improvements in the acupuncture group were better than those in the medication group ( all P < 0.01 ) .
-RESULTS	The curative and markedly effective rate was 90.7 % ( 136/150 ) in the acupuncture group , better than 66.0 % ( 99/150 ) in the medication group ( P < 0.01 ) .
-CONCLUSIONS	Acupuncture at three lines of cervical Jiaji ( EX-B 2 ) achieves the significant clinical efficacy on cervical spondylosis .
-CONCLUSIONS	This therapy is superior to relieving symptoms and physical signs and recovering adaptability as compared with jingfukang granules .
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-###25981812
-BACKGROUND	The standard of care for operable , stage I , non-small-cell lung cancer ( NSCLC ) is lobectomy with mediastinal lymph node dissection or sampling .
-BACKGROUND	Stereotactic ablative radiotherapy ( SABR ) for inoperable stage I NSCLC has shown promising results , but two independent , randomised , phase 3 trials of SABR in patients with operable stage I NSCLC ( STARS and ROSEL ) closed early due to slow accrual .
-BACKGROUND	We aimed to assess overall survival for SABR versus surgery by pooling data from these trials .
-METHODS	Eligible patients in the STARS and ROSEL studies were those with clinical T1-2a ( < 4 cm ) , N0M0 , operable NSCLC .
-METHODS	Patients were randomly assigned in a 1:1 ratio to SABR or lobectomy with mediastinal lymph node dissection or sampling .
-METHODS	We did a pooled analysis in the intention-to-treat population using overall survival as the primary endpoint .
-METHODS	Both trials are registered with ClinicalTrials.gov ( STARS : NCT00840749 ; ROSEL : NCT00687986 ) .
-RESULTS	58 patients were enrolled and randomly assigned ( 31 to SABR and 27 to surgery ) .
-RESULTS	Median follow-up was 402 months ( IQR 230-473 ) for the SABR group and 354 months ( 189-407 ) for the surgery group .
-RESULTS	Six patients in the surgery group died compared with one patient in the SABR group .
-RESULTS	Estimated overall survival at 3 years was 95 % ( 95 % CI 85-100 ) in the SABR group compared with 79 % ( 64-97 ) in the surgery group ( hazard ratio [ HR ] 014 [ 95 % CI 0017-1190 ] , log-rank p = 0037 ) .
-RESULTS	Recurrence-free survival at 3 years was 86 % ( 95 % CI 74-100 ) in the SABR group and 80 % ( 65-97 ) in the surgery group ( HR 069 [ 95 % CI 021-229 ] , log-rank p = 054 ) .
-RESULTS	In the surgery group , one patient had regional nodal recurrence and two had distant metastases ; in the SABR group , one patient had local recurrence , four had regional nodal recurrence , and one had distant metastases .
-RESULTS	Three ( 10 % ) patients in the SABR group had grade 3 treatment-related adverse events ( three [ 10 % ] chest wall pain , two [ 6 % ] dyspnoea or cough , and one [ 3 % ] fatigue and rib fracture ) .
-RESULTS	No patients given SABR had grade 4 events or treatment-related death .
-RESULTS	In the surgery group , one ( 4 % ) patient died of surgical complications and 12 ( 44 % ) patients had grade 3-4 treatment-related adverse events .
-RESULTS	Grade 3 events occurring in more than one patient in the surgery group were dyspnoea ( four [ 15 % ] patients ) , chest pain ( four [ 15 % ] patients ) , and lung infections ( two [ 7 % ] ) .
-CONCLUSIONS	SABR could be an option for treating operable stage I NSCLC .
-CONCLUSIONS	Because of the small patient sample size and short follow-up , additional randomised studies comparing SABR with surgery in operable patients are warranted .
-BACKGROUND	Accuray Inc , Netherlands Organisation for Health Research and Development , NCI Cancer Center Support , NCI Clinical and Translational Science Award .
-
-###25335963
-BACKGROUND	Major depression is a serious mental disorder that causes substantial distress and impairment in individuals and places an enormous burden on society .
-BACKGROUND	Although antidepressant treatment is the most common therapy provided in routine practice , there is little evidence to guide second-line therapy for patients who have failed to respond to antidepressants .
-BACKGROUND	The aim of this paper is to describe the study protocol for a randomised controlled trial that measures the clinical effectiveness of cognitive behavioural therapy ( CBT ) as an augmentation strategy to treat patients with non-psychotic major depression identified as suboptimal responders to usual depression care .
-METHODS	The current study is a 16-week assessor-blinded randomised , parallel-groups superiority trial with 12-month follow-up at an outpatient clinic as part of usual depression care .
-METHODS	Patients aged 20-65years with Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition ( DSM-IV ) Major Depressive Disorder who have experienced at least one failed trial of antidepressants as part of usual depression care , will be randomly assigned to receive CBT plus treatment as usual , or treatment as usual alone .
-METHODS	The primary outcome is the change in clinician-rated 17-item GRID-Hamilton Depression Rating Scale ( GRID-HAMD ) score at 16weeks , and secondary outcomes include severity and change in scores of subjective depression symptoms , proportion of responders and remitters , safety and quality of life .
-METHODS	The primary population will be the intention-to-treat patients .
-BACKGROUND	All protocols and the informed consent form comply with the Ethics Guideline for Clinical Research ( Japanese Ministry of Health , Labour and Welfare ) .
-BACKGROUND	Ethics review committees at the Keio University School of Medicine and the Sakuragaoka Memorial Hospital approved the study protocol .
-BACKGROUND	The results of the study will be disseminated at several research conferences and as published articles in peer-reviewed journals .
-BACKGROUND	The study will be implemented and reported in line with the CONSORT statement .
-BACKGROUND	UMIN Clinical Trials Registry : UMIN000001218 .
-
-###25316430
-OBJECTIVE	The enigmatic etiology of neurodegenerative diseases poses a challenge for the development of novel and efficient drugs .
-OBJECTIVE	The objective of the present study was to evaluate the efficacy of a polyherbal ( test ) formulation on cognitive functions , inflammatory markers and oxidative stress in healthy elderly as well as senile dementia of Alzheimer 's type ( SDAT ) patients .
-METHODS	A randomized double-blind placebo - and active-controlled clinical trial was performed in healthy elderly subjects and SDAT patients with an age range of 60-75 years .
-METHODS	The polyherbal test formulation along with a placebo was given to healthy elderly subjects while the SDAT patients received either the test formulation containing extracts of Bacopa monnieri ( whole plant ) , Hippophae rhamnoides ( leaves and fruits ) and Dioscorea bulbifera ( bulbils ) at a dose of 500 mg or donepezil drug ( Aricept ) at a dose of 10 mg , twice daily , for a period of 12 months .
-METHODS	After every three months , cognitive functions were assessed by determining the mini mental state examination ( MMSE ) score , digital symbol substitution ( DSS ; subtest of the Wechsler Adult Intelligence Scale-Revised ) , immediate and delayed word recall ( digital memory apparatus-Medicaid systems , Chandigarh , India ) , attention span ( Attention Span Apparatus-Medicaid systems , Chandigarh , India ) , functional activity questionnaire ( FAQ ) and depression ( geriatric depression scale ) scores .
-METHODS	Further inflammatory markers and level of oxidative stress were analyzed using standard biochemical tests .
-RESULTS	The trial was performed in 109 healthy subjects and 123 SDAT patients of whom 97 healthy subjects and 104 SDAT patients completed the study .
-RESULTS	Administration of the test formulation for a period of 12 months was effective in improving cognitive functions in the SDAT patients , when compared to the donepezil-treated group , as determined by the DSS ( 38.984 3.016 vs 35.852 4.906 , P = 0.0001 ) , word recall immediate ( 3.594 1.003 vs 2.794 0.593 , P < 0.0001 ) and attention span ( 4.918 1.239 vs 4.396 0.913 , P = 0.0208 ) scores .
-RESULTS	A significant improvement in the FAQ ( 11.873 2.751 vs 9.801 1.458 , P < 0.0001 ) and depression ( 16.387 2.116 vs 21.006 2.778 , P < 0.0001 ) scores was also observed , whereas no significant differences were observed in the MMSE and word recall delayed scores .
-RESULTS	The level of inflammation and oxidative stress was markedly reduced in the SDAT patients treated with the test formulation when compared to the donepezil-treated group indicating a likely mechanism of action of the test formulation ( homocysteine 30.22 3.87 vs 44.73 7.11 nmol/L , P < 0.0001 ; C-reactive protein [ CRP ] 4.751 1.149 vs 5.887 1.049 mg/L , P < 0.0001 ; tumour necrosis factor alpha [ TNF - ] 1139.45 198.87 vs 1598.77 298.52 pg/ml , P < 0.0001 ; superoxide dismutase [ SOD ] 1145.92 228.75 vs 1296 225.72 U/g Hb , P = 0.0013 ; glutathione peroxidase [ GPx ] 20.78 3.14 vs 25.99 4.11 U/g Hb , P < 0.0001 ; glutathione [ GSH ] 9.358 2.139 vs 6.831 1.139 U/g Hb , P < 0.0001 ; thiobarbituric acid reactive substances [ TBARS ] 131.62 29.68 vs 176.40 68.11 nmol/g Hb , P < 0.0001 ) .
-RESULTS	Similarly , when healthy elderly subjects treated with the test formulation for 12 months were compared to the placebo group , a significant ( P < 0.001 ) improvement in cognitive measures ( MMSE , DSS , word recall delayed but not immediate , attention span , FAQ and depression scores ) and a reduction in inflammation ( reduction in homocysteine , CRP , IL-6 and TNF - levels ) and oxidative stress levels ( reduction in SOD , GPx and TBARS and increase in GSH ) was observed .
-RESULTS	This indicated a protective effect of the test formulation in managing cognitive decline associated with the ageing process .
-CONCLUSIONS	The results of this study demonstrate the therapeutic potential of this novel polyherbal formulation for the management and treatment of SDAT .
-
-###24639421
-OBJECTIVE	To determine the costs and cost-effectiveness of an early childhood home visiting program delivered to families in socio-economically disadvantaged areas of Sydney , Australia during 2007-2010 .
-METHODS	Economic evaluation of a randomized controlled trial , the healthy beginnings ( HB ) trial , from the perspective of the health funder .
-METHODS	Intervention resources were determined from local health district records in 2012 $ AUD .
-METHODS	Health-care resource utilization was determined through patient-level data linkage .
-RESULTS	The cost of HB intervention in the clinical trial over 2 years was $ 1309 per child ( 2012 $ AUD ) .
-RESULTS	The incremental cost-effectiveness ratio was $ 4230 per unit BMI avoided and $ 631 per 0.1 reduction in BMI z-score .
-RESULTS	It was estimated that the program could be delivered in practice for $ 709 per child ; with incremental cost-effectiveness ratios of $ 2697 per unit BMI avoided and $ 376 per 0.1 reduction in BMI z-score .
-CONCLUSIONS	We present the first economic evaluation of an effective obesity prevention initiative in early childhood .
-CONCLUSIONS	HB is a moderately priced intervention with demonstrated effectiveness that offers similar or better value for money than existing obesity prevention or treatment interventions targeted at older children .
-
-###25574111
-OBJECTIVE	To compare the Helicobacter pylori ( H. pylori ) eradication rate of clarithromycin-based triple therapy , metronidazole-based triple therapy , sequential therapy and concomitant therapy .
-METHODS	A total of 680 patients infected with H. pylori were divided into 4 groups and each group was treated with a different eradication therapy .
-METHODS	Clarithromycin-based triple therapy was applied to the first group [ rabeprazole , amoxicillin and clarithromycin ( PAC ) group : proton pump inhibitor ( PPI ) , amoxicillin , clarithromycin ] , whereas the second group was treated with metronidazole-based triple therapy [ rabeprazole , amoxicillin and metronidazole ( PAM ) group : PPI , amoxicillin , metronidazole ] .
-METHODS	The third group was treated with rabeprazole and amoxicillin , followed by rabeprazole , clarithromycin and metronidazole ( sequential group ) .
-METHODS	The final group was simultaneously treated with rabeprazole , amoxicillin clarithromycin and metronidazole ( concomitant therapy group ) .
-METHODS	In the case of a failure to eradicate H. pylori , second-line quadruple and third-line eradication therapies were administered .
-RESULTS	The per protocol ( PP ) analysis was performed on 143 , 139 , 141 and 143 patients in the PAC , PAM , sequential and concomitant groups , respectively .
-RESULTS	We excluded patients who did not receive a C ( 13 ) - urea breath test ( 22 , 20 , 23 and 22 patients , respectively ) and patients with less than an 80 % compliance level ( 5 , 11 , 6 and 5 patients , respectively ) .
-RESULTS	The eradication rates were 76.2 % ( 109/143 ) in the PAC group , 84.2 % ( 117/139 ) in the PAM group , 84.4 % ( 119/141 ) in the sequential group and 94.4 % ( 135/143 ) in the concomitant group ( P = 0.0002 ) .
-RESULTS	All 14 patients who failed second-line therapy were treated with third-line eradication therapy .
-RESULTS	Among these 14 patients , 6 infections were successfully eradicated with the third-line therapy .
-RESULTS	Both PP and intention-to-treat analysis showed an eradication rate of 42.9 % ( 6/14 ) .
-RESULTS	In the PAC group , 3 of 4 patients were successfully cured ( 3/4 , 75 % ) ; 2 of 2 patients in the PAM group ( 2/2 , 100 % ) and 1 of 5 patients in the sequential group ( 1/5 , 20 % ) were also cured .
-RESULTS	In the concomitant group , all 3 patients failed ( 0/3 , 0 % ) .
-CONCLUSIONS	The eradication rate for the concomitant therapy was much higher than those of the standard triple therapy or sequential therapy ( ClinicalTrials.gov number NCT01922765 ) .
-
-###24933332
-BACKGROUND	Ramucirumab is a human IgG1 monoclonal antibody that targets the extracellular domain of VEGFR-2 .
-BACKGROUND	We aimed to assess efficacy and safety of treatment with docetaxel plus ramucirumab or placebo as second-line treatment for patients with stage IV non-small-cell-lung cancer ( NSCLC ) after platinum-based therapy .
-METHODS	In this multicentre , double-blind , randomised phase 3 trial ( REVEL ) , we enrolled patients with squamous or non-squamous NSCLC who had progressed during or after a first-line platinum-based chemotherapy regimen .
-METHODS	Patients were randomly allocated ( 1:1 ) with a centralised , interactive voice-response system ( stratified by sex , region , performance status , and previous maintenance therapy [ yes vs no ] ) to receive docetaxel 75 mg/m ( 2 ) and either ramucirumab ( 10 mg/kg ) or placebo on day 1 of a 21 day cycle until disease progression , unacceptable toxicity , withdrawal , or death .
-METHODS	The primary endpoint was overall survival in all patients allocated to treatment .
-METHODS	We assessed adverse events according to treatment received .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT01168973 .
-RESULTS	Between Dec 3 , 2010 , and Jan 24 , 2013 , we screened 1825 patients , of whom 1253 patients were randomly allocated to treatment .
-RESULTS	Median overall survival was 105 months ( IQR 51-212 ) for 628 patients allocated ramucirumab plus docetaxel and 91 months ( 42-180 ) for 625 patients who received placebo plus docetaxel ( hazard ratio 086 , 95 % CI 075-098 ; p = 0023 ) .
-RESULTS	Median progression-free survival was 45 months ( IQR 23-83 ) for the ramucirumab group compared with 30 months ( 14-69 ) for the control group ( 076 , 068-086 ; p < 00001 ) .
-RESULTS	We noted treatment-emergent adverse events in 613 ( 98 % ) of 627 patients in the ramucirumab safety population and 594 ( 95 % ) of 618 patients in the control safety population .
-RESULTS	The most common grade 3 or worse adverse events were neutropenia ( 306 patients [ 49 % ] in the ramucirumab group vs 246 [ 40 % ] in the control group ) , febrile neutropenia ( 100 [ 16 % ] vs 62 [ 10 % ] ) , fatigue ( 88 [ 14 % ] vs 65 [ 10 % ] ) , leucopenia ( 86 [ 14 % ] vs 77 [ 12 % ] ) , and hypertension ( 35 [ 6 % ] vs 13 [ 2 % ] ) .
-RESULTS	The numbers of deaths from adverse events ( 31 [ 5 % ] vs 35 [ 6 % ] ) and grade 3 or worse pulmonary haemorrhage ( eight [ 1 % ] vs eight [ 1 % ] ) did not differ between groups .
-RESULTS	Toxicities were manageable with appropriate dose reductions and supportive care .
-CONCLUSIONS	Ramucirumab plus docetaxel improves survival as second-line treatment of patients with stage IV NSCLC .
-BACKGROUND	Eli Lilly .
-
-###25158273
-OBJECTIVE	We compared the long-term success of desmopressin sublingual lyophilisate formulation and enuretic alarm therapy in children with primary monosymptomatic nocturnal enuresis , and determined predictive factors for treatment success .
-METHODS	A total of 142 children with primary monosymptomatic nocturnal enuresis were randomized to receive treatment consisting of desmopressin or enuretic alarm for 6 months .
-METHODS	Treatment compliance and response were reviewed monthly in each patient using a 30-day bed-wetting diary .
-METHODS	Outcomes were assessed according to International Children 's Continence Society criteria , and success rates at 6 and 12 months were compared for desmopressin and enuretic alarm .
-METHODS	Additional intention to treat analyses were performed , considering cases with missing data as failures .
-METHODS	Possible demographic factors predicting success were investigated by logistic regression analysis .
-RESULTS	Overall 4 children ( 5.2 % ) in the desmopressin group and 20 ( 30.7 % ) in the enuretic alarm group withdrew after randomization .
-RESULTS	Based on patients who completed 6 months of treatment , success ( more than 90 % reduction in wet nights per month ) was achieved in 76.8 % and 61.8 % of children in the desmopressin and enuretic alarm groups , respectively .
-RESULTS	At 12 months 77.8 % of those receiving desmopressin and 75 % of those treated with enuretic alarm had success .
-RESULTS	However , long-term success rate was significantly higher with desmopressin ( 68.8 % vs 46.2 % ) if intention to treat population was considered .
-RESULTS	Multivariate analysis revealed treatment group , severity of enuresis and monthly income as independent predictors of cure at 6 months .
-CONCLUSIONS	In compliant patients desmopressin lyophilisate and enuretic alarm provided equivalent success at the end of treatment and after extended followup .
-CONCLUSIONS	Alarm therapy had a high rate of early withdrawal from therapy and consequently lower rates of success on intention to treat analyses .
-CONCLUSIONS	Severe enuresis ( more than 5 wet nights weekly ) is an important predictive factor for cure after first-line treatment .
-
-###24675386
-OBJECTIVE	Following from previous research in which post-encoding suggestions of threat led to the development of a memory bias ( in the presumed absence of an attentional bias ; Senn & Radomsky , 2012 ) , we sought to examine whether the development of a similar threat-relevant memory bias could be fostered via a purely informational pathway .
-METHODS	A vignette about a classroom interaction was read aloud to ( n = 96 ) undergraduate participants who then completed a post-encoding recall test .
-METHODS	Participants were told that the experimenter forgot to read the last sentence of the vignette , and were then randomly assigned either to the Threat condition , in which the additional statement indicated that a character in the vignette had a highly contagious flu , or to the No-Threat condition , in which the additional statement indicated that a character in the vignette had been accepted to graduate school .
-METHODS	A second recall test was then administered .
-RESULTS	Participants in the Threat condition ( but not those in the No-Threat condition ) demonstrated aproportionate memory bias in favor of threatening information .
-RESULTS	This bias was not evident at the initial recall test .
-CONCLUSIONS	Time spent engaging in active recall was not assessed .
-CONCLUSIONS	Also , although the study was designed to minimize demand characteristics , it is possible that these played a role .
-CONCLUSIONS	An explicit memory bias for threat can be created through informational means alone , even when no threat was present at encoding .
-CONCLUSIONS	Results are discussed in terms of pathways to fear and of cognitive approaches to understanding and treating anxiety disorders .
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-###24471325
-OBJECTIVE	To evaluate the multi-function rapid allergic skin test instrument for application in drug allergy testing .
-METHODS	Three hundred patients were planned to be treated with cephalosporins Injection were divided randomly into 3 groups , the new allergic skin test instrument group , normal allergic skin test instrument group , and traditional skin test group , the true positive rate and false positive rate were calculated .
-METHODS	Using multifunctional rapid allergy skin test was carried out on 210 cases of volunteers preliminary clinical evaluation of traditional Chinese medicine injections skin test .
-RESULTS	There were no significance difference between the new allergic skin test instrument group and control group in the true positive rate .
-RESULTS	As compared with the control group , a significance difference was found between the new allergic skin test instrument group and control group in false positive rate respectively ( P < 0.05 ) .
-CONCLUSIONS	The multi-function rapid allergic skin test instrument is safe and easy to use , with a higher rate of accuracy and lower false positive rate .
-
-###25659256
-BACKGROUND	Current medical knowledge has provided us with a wide range of possibilities of treating chronic wounds .
-BACKGROUND	Over the recent decades , in particular , significant progress has been made in this field .
-BACKGROUND	The authors present an overview of current knowledge of chronic wound healing , pointing out the surgeons role in the process of chronic wound management .
-BACKGROUND	Using surgical therapy , we are able to heal a chronic wound in a shorter period of time , particularly if the treatment is accelerated by the application of platelet-rich plasma ( PRP ) as a source of growth factors .
-METHODS	The pilot randomized prospective study included four patients with chronic wounds of the lower leg after previous failure of conservative therapy who were indicated for skin transplantation .
-METHODS	Following previous vacuum-assisted closure therapy , the patients undergoing skin transplantation were prospectively randomized into two groups .
-METHODS	Autologous PRP was used in one of the groups and standard skin transplantation without PRP was performed in the other one .
-RESULTS	In the PRP group , 99 % of the wound areas were healed on the 15th day after the operation .
-RESULTS	In the other group , 90 % of the areas were healed on the 15th day following the operation .
-RESULTS	In the PRP group , complete healing of the defect occurred in both patients at 15 and 20 days post-surgery .
-RESULTS	In the second group , one patient completely healed within 28 days ; the other one was not fully healed even at 3 months post-surgery .
-CONCLUSIONS	Most patient groups at great risk may benefit from the method using PRP , as well as patients with chronic wounds who have failed conventional methods available for both general and local therapy .
-CONCLUSIONS	This fact has been confirmed by the authors initial experience presented.Key words : platelet-rich plasma ( PRP ) - platelets wound healing chronic wound .
-
-###24248549
-OBJECTIVE	To compare lag-screw sliding characteristics and fixation stability of two cephalomedullary nails ( CMN ) with different lag-screw designs ( solid and telescopic ) , we conducted a biomechanical study and an analysis of clinical results .
-METHODS	Six pairs of cadaver femurs with simulated intertrochanteric fractures were randomly assigned to one of two CMN fixations .
-METHODS	Femur constructs were statically then cyclically loaded on an MTS machine .
-METHODS	Lag-screw sliding and inferior and lateral femoral head displacements were measured , following which failure strength of the construct was determined .
-METHODS	Forty-five patients with intertrochanteric fractures treated with these CMN were identified .
-METHODS	Medical records and radiographs were reviewed and analyzed using Fisher 's exact test and Student 's t test to determine lag-screw sliding .
-RESULTS	No difference was seen with cycling in inferior femoral head displacement between the two screw designs .
-RESULTS	The solid screw had an average inferior head displacement of 1.75 mm compared with 1.59 mm for the telescoping screw ( p = 0.772 ) .
-RESULTS	The solid lag screws slid an average of 2.79 mm lateral from the nail , whereas the telescoping screws slid an average of 0.27 mm ( p = 0.003 ) .
-RESULTS	In our clinical review , the average lateral sliding of the telescoping screw was 0.5 mm and of the solid screw was 3.7 mm ( p < 0.001 ) .
-RESULTS	Despite differences in lateral sliding , there were no reoperations for prominent or painful hardware in either group .
-CONCLUSIONS	Both designs are acceptable devices for stabilization of intertrochanteric fractures .
-CONCLUSIONS	Clinical and biomechanical data demonstrate greater lateral sliding in the solid lag-screw group , making for greater potential for lateral-sided hip pain in CMNs with solid lag screws as opposed to telescoping lag screws .
-
-###24793722
-OBJECTIVE	Neonatal diagnoses are often used as surrogate endpoints for longer-term outcomes .
-OBJECTIVE	We sought to characterize the correlation between neonatal diagnoses and early childhood neurodevelopment .
-METHODS	We conducted secondary analysis of a multicenter randomized controlled trial of antenatal magnesium sulfate vs placebo administered to women at imminent risk for delivery < 32.0 weeks to prevent death and cerebral palsy in their offspring .
-METHODS	Singletons and twins delivering 23.0-33 .9 weeks who survived to hospital discharge and had 2-year-old outcome data were included .
-METHODS	Those surviving to age 2 years were assessed by trained physicians and the Bayley II Scales of Infant Development Mental Development and Psychomotor Development Indices .
-METHODS	Neonatal diagnoses at the time of each baby 's initial hospital discharge were examined singly and in combination to determine those most predictive of childhood neurodevelopmental impairment , defined as a childhood diagnosis of moderate/severe cerebral palsy and/or Bayley scores > 2 SD below the mean .
-METHODS	Data were analyzed by multiple regression models and area under receiver operating characteristic curves .
-RESULTS	A total of 1771 children met criteria .
-RESULTS	Children were delivered at a mean of 29.4 weeks ' gestation .
-RESULTS	In all , 459 ( 25.9 % ) had neurodevelopmental impairment .
-RESULTS	In models controlling for gestational age at delivery , maternal education , maternal race , tobacco/alcohol/drug use during pregnancy , randomization to magnesium , fetal sex , and chorioamnionitis , individual neonatal morbidities were moderately predictive of childhood neurodevelopmental impairment ( best model area under receiver operating characteristic curve , 0.68 ; 95 % confidence interval , 0.65-0 .71 ) .
-RESULTS	Combinations of 2 , 3 , and 4 morbidities did not improve the prediction of neurodevelopmental impairment .
-CONCLUSIONS	Approximately 1 in 4 previously preterm children had neurodevelopmental impairment at age 2 years .
-CONCLUSIONS	Prediction of childhood outcomes from neonatal diagnoses remains imperfect .
-
-###24313916
-OBJECTIVE	This 24-week , multicenter , double-blind , randomized , placebo-controlled study ( NCT00791999 ) compared efficacy and safety of certolizumab pegol ( CZP ) in combination with methotrexate ( MTX ) vs placebo plus MTX in Japanese rheumatoid arthritis ( RA ) patients with inadequate response to MTX .
-METHODS	In total , 316 patients were randomized 1:1:1:1 to subcutaneous CZP 100 , 200 , or 400 mg ( induction dose : 200 mg or 400 mg CZP at Weeks 0 , 2 , and 4 ) plus MTX or placebo plus MTX every 2 weeks .
-METHODS	Primary endpoint was ACR20 response at Week 12 .
-RESULTS	ACR20 response rates were 62.5 % , 76.8 % , 77.6 % , and 28.6 % at Week 12 , and 61.1 % , 73.2 % , 71.8 % , and 24.7 % at Week 24 for CZP 100 , 200 , and 400 mg , and placebo groups , respectively , with statistical significance between each CZP group and placebo .
-RESULTS	Change in Total Sharp Score over 24 weeks was significantly smaller in CZP 200 and 400 mg groups vs placebo .
-RESULTS	Improvements in health-related quality of life ( HRQoL ) were observed in all three CZP groups vs placebo .
-RESULTS	Incidence of adverse events was similar between CZP groups .
-CONCLUSIONS	CZP plus MTX resulted in rapid , sustained reductions in RA signs and symptoms in Japanese patients with inadequate response to MTX , with significant inhibition of radiographic progression and improved HRQoL .
-
-###24329506
-BACKGROUND	Growth hormone deficiency ( GHD ) is associated with reduced bone mineral content and increased risk of osteoporotic fractures .
-BACKGROUND	Reduced peak bone mass might explain the low bone mineral density ( BMD ) among patients with childhood onset GHD ( CO-GHD ) whilst the cause of osteopenia in adult-onset GHD ( AO-GHD ) is not fully understood .
-OBJECTIVE	Prospective multicentric study to asses bone status in GHD adults after two years of recombinant growth hormone replacement treatment .
-METHODS	In 94 GHD adults ( 49 men ; 34.5 yrs ) we have measured BMD and bone markers ( CTX , osteocalcin ) during two years of rhGH treatment ( at baseline , after 3 and 6 months , and after 1 and 2 years ) .
-METHODS	Patients were adequately substituted for GHD and other pituitary deficiencies .
-RESULTS	We have observed an increase in BMD-lumbar spine : n = 42 , 0.8155 0.9418 g/cm2 , p < 0.0001 ; femoral neck n = 41 ; 0.8468 0.9031 ; p = 0.0004 ; BMD-whole body 1.0179 1.0774 ; p = 0.0003 .
-RESULTS	We have compared gender difference : BMD-L-spine by 15.8 % in men ( n = 21 ) and by 5.6 % in women ( n = 19 ) ( p = 0.008 ) ; BMD-femoral neck increased by 11.03 % in men and by about 3.0 % in women ( p = 0.032 ) .
-RESULTS	In women , the initial decrease in BMD was recorded after 3 months .
-RESULTS	CO-GHD adults yielded a higher increase in BMD - L-spine ( 16.6 % , p = 0.022 ) .
-RESULTS	A correlation exists between IGF-I levels and BMD in lumbar spine ( 1st year : R = 0.348 , p = 0.026 ; 2nd year : R = 0.33 , p = 0.0081 ) and between IGF-I and osteocalcin ( 1st year : R = 0.383 ; p = 0.0038 ) .
-CONCLUSIONS	Two-year therapy with recombinant human growth hormone improved bone status .
-CONCLUSIONS	IGF-I appears to be a good indicator of rhGH effect on bone ( Tab .
-CONCLUSIONS	3 , Fig. 9 , Ref .
-CONCLUSIONS	36 ) .
-CONCLUSIONS	Text in PDF www.elis.sk .
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-###25157964
-OBJECTIVE	Up to 70 % of patients with treatment-resistant schizophrenia do not respond to clozapine .
-OBJECTIVE	Pharmacological augmentation to clozapine has been studied with unimpressive results .
-OBJECTIVE	The authors examined the use of ECT as an augmentation to clozapine for treatment-refractory schizophrenia .
-METHODS	In a randomized single-blind 8-week study , patients with clozapine-resistant schizophrenia were assigned to treatment as usual ( clozapine group ) or a course of bilateral ECT plus clozapine ( ECT plus clozapine group ) .
-METHODS	Nonresponders from the clozapine group received an 8-week open trial of ECT ( crossover phase ) .
-METHODS	ECT was performed three times per week for the first 4 weeks and twice weekly for the last 4 weeks .
-METHODS	Clozapine dosages remained constant .
-METHODS	Response was defined as 40 % reduction in symptoms based on the psychotic symptom subscale of the Brief Psychiatric Rating Scale , a Clinical Global Impressions ( CGI ) - severity rating < 3 , and a CGI-improvement rating 2 .
-RESULTS	The intent-to-treat sample included 39 participants ( ECT plus clozapine group , N = 20 ; clozapine group , N = 19 ) .
-RESULTS	All 19 patients from the clozapine group received ECT in the crossover phase .
-RESULTS	Fifty percent of the ECT plus clozapine patients met the response criterion .
-RESULTS	None of the patients in the clozapine group met the criterion .
-RESULTS	In the crossover phase , response was 47 % .
-RESULTS	There were no discernible differences between groups on global cognition .
-RESULTS	Two patients required the postponement of an ECT session because of mild confusion .
-CONCLUSIONS	The augmentation of clozapine with ECT is a safe and effective treatment option .
-CONCLUSIONS	Further research is required to determine the persistence of the improvement and the potential need for maintenance treatments .
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-###24851692
-OBJECTIVE	To evaluate the performance effect of short-term catheter-directed thrombolysis with different dosage of rt-PA allied with endovascular interventional therapy for patients with acute lower limb ischemia .
-METHODS	To separate 84 consecutive patients suffered from acute lower limb ischemia into two groups at random , then adopt catheter-directed thrombolysis for each group of patients injected 20 mg ( Group A ) or 10 mg ( Group B ) rt-PA into the occlusive lesion correspondingly , and subsequently perform endovascular intervention on significant underlying lesions on the base of angiography results .
-METHODS	Adopt statistical methods to assess treatment effectiveness , rates of complication and amputation rates within 30 days , 6 months or 12 months .
-METHODS	The statistic analysis was performed under SPSS 16.0 format , and adopts t test and ( 2 ) test .
-RESULTS	There was no statistical difference on patient characteristics and lesions between both groups ( P > 0.05 ) .
-RESULTS	Procedural success rates as well clinical success rates were all 100 % .
-RESULTS	Not incur any diversity on thrombolysis effectiveness between both groups injected different dosage of rt-PA ( P > 0.05 ) .
-RESULTS	Not found major differences on ratios of PTA or implant stent between both groups ( P > 0.05 ) .
-RESULTS	During the follow-up period of 30-day , 6 - , 12 - months , there were no statistical differences on the amputation-free survival rates and complication rates between both groups .
-CONCLUSIONS	Whereas short-term catheter-directed thrombolysis combined with endovascular interventional therapy won good operation effectiveness on patients with acute lower limb ischemia , moreover the dosage of rt-PA did not impact on thrombolysis , it is worthy to be applied in the clinical practice .
-
-###24285581
-OBJECTIVE	The Prevencin con Dieta Mediterrnea ( PREDIMED ) trial showed that a Mediterranean diet ( MedDiet ) supplemented with either extra virgin olive oil or 30 g/d of mixed nuts reduced incident cardiovascular events compared with a control ( low fat ) diet .
-OBJECTIVE	The mechanisms of cardiovascular protection afforded by MedDiets remain to be uncovered .
-OBJECTIVE	We assessed the effect of both supplemented MedDiets on internal carotid intima-media thickness ( ICA-IMT ) and plaque height , the ultrasound features that best predict future cardiovascular events , in subjects at high cardiovascular risk .
-RESULTS	In a PREDIMED subcohort ( n = 175 ) , plaque height and carotid IMT of 3 prespecified segments ( ICA , bifurcation , and common ) were sonographically assessed at baseline and after intervention for a mean of 2.4 years .
-RESULTS	We evaluated 164 subjects with complete data .
-RESULTS	In a multivariate model , mean ICA-IMT progressed in the control diet group ( mean [ 95 % confidence interval ] , 0.052 mm [ -0.014 to 0.118 mm ] ) , whereas it regressed in the MedDiet + nuts group ( -0.084 mm [ -0.158 to -0.010 mm ] ; P = 0.024 versus control ) .
-RESULTS	Similar results were observed for maximum ICA-IMT ( control , 0.188 mm [ 0.077 to 0.299 mm ] ; MedDiet + nuts , -0.030 mm [ -0.153 to 0.093 mm ] ; P = 0.034 ) and maximum plaque height ( control , 0.106 mm [ 0.001 to 0.210 mm ] ; MedDiet + nuts , -0.091 mm [ -0.206 to 0.023 mm ] ; P = 0.047 ) .
-RESULTS	There were no changes in ICA-IMT or plaque after the MedDiet + extra virgin olive oil .
-CONCLUSIONS	Compared with a control diet , consumption of a MedDiet supplemented with nuts is associated with delayed progression of ICA-IMT and plaque .
-CONCLUSIONS	The results contribute mechanistic evidence for the reduction of cardiovascular events observed in the PREDIMED trial .
-BACKGROUND	http://www.controlled-trials.com .
-BACKGROUND	Unique identifier : ISRCTN35739639 .
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-###24639432
-BACKGROUND	This study assessed the efficacy and safety of the once-daily glucagon-like peptide-1 receptor agonist , lixisenatide , in Asian patients with type 2 diabetes mellitus inadequately controlled on metforminsulfonylurea .
-METHODS	In this 24-week , double-blind , placebo-controlled , multinational study , patients were randomized to lixisenatide 20 g once daily or placebo .
-METHODS	The primary endpoint was absolute change in glycated haemoglobin ( HbA1c ) from baseline to week 24 .
-RESULTS	A total of 391 patients were randomized .
-RESULTS	Lixisenatide significantly reduced HbA1c levels compared with placebo ( LS mean difference : -0.36 % , p = 0.0004 ) .
-RESULTS	A significantly higher proportion of lixisenatide-treated patients achieved HbA1c targets of < 7 % ( p = 0.003 ) and 6.5 % ( p = 0.001 ) versus placebo .
-RESULTS	Lixisenatide was associated with a statistically significant reduction in 2-h postprandial plasma glucose after a standardized breakfast versus placebo ( LS mean difference : -4.28 mmol/L , p < 0.0001 ) and a significant reduction in fasting plasma glucose ( p = 0.0109 ) .
-RESULTS	There was no difference in weight loss versus placebo , with a modest reduction in body weight reported for both groups ( lixisenatide : -1.50 kg , placebo : -1.24 kg ; p = 0.296 ) .
-RESULTS	The incidence of treatment-emergent adverse events ( TEAEs ) was 64.3 % with lixisenatide versus 47.4 % with placebo , with serious TEAEs reported in 1.5 % versus 2.1 % of patients , respectively .
-RESULTS	The most common TEAE in the lixisenatide group was nausea ( 16.3 % vs 2.6 % with placebo ) .
-RESULTS	The incidence of symptomatic hypoglycaemia was 5.6 % with lixisenatide treatment and 2.6 % with placebo ( p = 0.1321 ) , with no severe symptomatic hypoglycaemia events reported .
-CONCLUSIONS	In Asian patients with type 2 diabetes mellitus insufficiently controlled on metforminsulfonylurea , lixisenatide significantly improved glycaemic control and was well tolerated during the 24-week study .
-
-###24837113
-BACKGROUND	School absenteeism because of infections is one of the most important problems facing both public and private primary schools .
-BACKGROUND	The aim of the study was to assess the impact of infections on school absenteeism and their reduction with a handwashing program using hand sanitizer .
-METHODS	The study was an 8-month-long , randomized , controlled open study ( N = 1,609 children , aged 4-12 years old ) at 5 state schools in Almeria ( Spain ) .
-METHODS	The experimental group ( EG ) washed their hands with soap and water , complemented with the use of hand sanitizer , and the control group ( CG ) followed the usual handwashing procedure .
-METHODS	The total number of episodes and days missed as well as those because of upper respiratory infections and gastrointestinal infections were compared in both groups with a Z-test .
-RESULTS	The students were absent 12,386 days in 7,945 episodes .
-RESULTS	The incidence of total absent episodes and percent of missed days , including those because of upper respiratory infections and gastrointestinal infections , were significantly lower in the EG than the CG ( P < .001 ) , and this was maintained through the flu pandemic period .
-CONCLUSIONS	School absenteeism because of infections in schools is reduced when a hand hygiene program utilizing sanitizing gels is properly carried out , especially during the flu season .
-
-###25062129
-OBJECTIVE	The purpose of the study was to measure contact lens lipid spoliation of silicone hydrogel PureVision ( balafilcon A ) and hydrogel Acuvue 2 ( etafilcon A ) contact lenses worn for 10 hours single use ( DD ) and 7 days of extended wear ( EW ) .
-METHODS	Two similar study populations ( DD , n = 55 ; EW , n = 53 ) , were enrolled at four study sites .
-METHODS	In each population , a bilateral , randomized , crossover ( lens material ) , subject-masked experimental design was followed .
-METHODS	Worn contact lenses were analyzed for lipid uptake using high-performance liquid chromatography by two laboratories : Alcon Laboratories ( right lens total uptake ) and OTG Research & Consultancy ( left lens total uptake and individual lipid classes ) .
-RESULTS	Lipid uptake was different for the two materials : total lipid ( p < 0.007 ) , cholesterol esters ( p < 0.001 ) , cholesterol ( p < 0.001 EW only ) , and triglycerides/phospholipids ( p < 0.001 ) were higher for balafilcon A , whereas fatty acid ( p < 0.0025 EW only ) was higher for etafilcon A.
-RESULTS	The ratio of the extracted lipids was also different : higher percentages of triglycerides/phospholipids ( p < 0.001 ) and cholesterol ( p < 0.001 EW only ) for balafilcon A and higher percentages of fatty acids/di - and monoglycerides ( p < 0.014 ) for etafilcon A.
-CONCLUSIONS	Total lipid uptake was highly material dependent .
-CONCLUSIONS	Both laboratories measured a greater uptake of lipids by the silicone hydrogel than the hydrogel material , a difference that was evident after only 10 hours of DD .
-CONCLUSIONS	Total lipid uptake was greater after 7 days of EW compared with 10 hours of DD .
-CONCLUSIONS	Of interest for contact lens spoliation and its avoidance was the differential lipid uptake profile , indicating material selectivity .
-CONCLUSIONS	Whereas greater differentiation between materials was possible after 7 days of EW for each material , the lipid uptake profile was similar for DD and EW , indicating a greater material effect than a wear modality effect .
-
-###24261345
-BACKGROUND	This study was done to investigate how nicardipine , remifentanil and dexmedetomidine affect the balance of the autonomic nervous system in patients receiving controlled hypotension under general anaesthesia by evaluating heart rate variability indices .
-METHODS	Sixty-two patients were randomly allocated to either the nicardipine-sevoflurane ( Group N , n = 21 ) , remifentanil-sevoflurane ( Group R , n = 21 ) or dexmedetomidine-sevoflurane ( Group D , n = 20 ) group for controlled hypotension during orthognathic surgery .
-METHODS	Electrocardiogram data acquisition was done after vital sign stabilization following anaesthesia induction ( T1 ) and 30min after controlled hypotension was induced ( T2 ) .
-RESULTS	Total power and low frequency ( LF ) power was significantly decreased at T2 compared with T1 in all groups , while a decrease in high frequency ( HF ) power was only observed in Group N ( P < 0.001 ) .
-RESULTS	LF/HF ratios of Group R and D were significantly suppressed at T2 compared with T1 ( P = 0.001 and P < 0.001 , respectively ) , but was increased Group N ( P = 0.009 ) .
-RESULTS	The LF/HF ratio of Group N was significantly higher than Group R and D at T2 ( P < 0.001 in both ) , with Group D showing a significantly lower LF/HF ratio compared with Group R ( P < 0.001 ) .
-CONCLUSIONS	Remifentanil and dexmedetomidine did not have sympathetic nervous system-stimulating effects during controlled hypotension , while remifentanil seemed to be superior in preserving the overall balance in autonomic nervous system activity .
-CONCLUSIONS	Nicardipine was found to stimulate the sympathetic nervous system , which may be problematic in patients vulnerable to disturbances in the autonomic nervous system .
-
-###26035185
-BACKGROUND	Vortioxetine ( Lu AA21004 ) is an antidepressant with a mechanism of action thought to be related to a combination of 2 pharmacologic actions : direct modulation of several receptors and inhibition of the serotonin transporter .
-OBJECTIVE	To evaluate the efficacy of vortioxetine 10 and 20 mg once daily in outpatients with major depressive disorder .
-METHODS	This 8-week , multicenter , randomized , double-blind , placebo-controlled , parallel-group study was conducted from July 2010 to January 2012 among adults with a primary diagnosis of recurrent major depressive disorder ( DSM-IV-TR ) .
-METHODS	Eligible subjects were randomized in 1:1:1 ratio to 1 of 3 treatment arms : vortioxetine 10 mg , vortioxetine 20 mg , or placebo once daily for 8 weeks .
-METHODS	Subjects who completed the 8-week trial entered a 2-week blinded discontinuation period to assess potential discontinuation symptoms .
-METHODS	The primary endpoint was the least squares mean change in Montgomery-Asberg Depression Rating Scale ( MADRS ) total score from baseline .
-METHODS	Key secondary outcomes were analyzed in the following prespecified sequential order : MADRS response ( 50 % decrease from baseline in total score ) , Clinical Global Impressions-Improvement score , change from baseline in MADRS total score in subjects with baseline Hamilton Anxiety Rating Scale score 20 , MADRS remission ( total score 10 ) , and change from baseline in Sheehan Disability Scale total score ( all at week 8 ) .
-RESULTS	A total of 462 subjects were randomized to placebo ( n = 157 ) , vortioxetine 10 mg ( n = 155 ) , and vortioxetine 20 mg ( n = 150 ) .
-RESULTS	Mean ( SE ) reductions from baseline in MADRS total score ( week 8 ) were -10.77 ( 0.807 ) , -12.96 ( 0.832 ) , and -14.41 ( 0.845 ) for the placebo , vortioxetine 10 mg ( P = .058 vs placebo ) , and vortioxetine 20 mg ( P = .002 vs placebo ) groups .
-RESULTS	MADRS response/remission was achieved in 28.4 % / 14.2 % , 33.8 % / 21.4 % , and 39.2 % / 22.3 % of subjects , respectively , in the 3 groups .
-RESULTS	Only MADRS response for vortioxetine 20 mg significantly separated from placebo ( P = .044 ) .
-RESULTS	Treatment was well tolerated , with the most frequently reported adverse events consisting of nausea , headache , diarrhea , and dizziness .
-CONCLUSIONS	Vortioxetine 20 mg significantly reduced MADRS total score at 8 weeks in this study population .
-CONCLUSIONS	Overall , vortioxetine was well tolerated in this study .
-BACKGROUND	ClinicalTrials.gov identifier : NCT01163266 .
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-###25516195
-OBJECTIVE	Experimental evidence has indicated the benefits of simvastatin for the treatment of subarachnoid hemorrhage .
-OBJECTIVE	Two randomized placebo-controlled pilot trials that used the highest clinically approved dose of simvastatin ( 80 mg daily ) gave positive results despite the fact that a lower dose of simvastatin ( 40 mg daily ) did not improve clinical outcomes .
-OBJECTIVE	We hypothesized that a high dose of 80 mg of simvastatin daily for 3 weeks would reduce the incidence of delayed ischemic deficits after subarachnoid hemorrhage compared with a lower dose ( 40 mg of simvastatin daily ) and lead to improved clinical outcomes .
-METHODS	The study design was a randomized controlled double-blinded clinical trial .
-METHODS	Patients with aneurysmal subarachnoid hemorrhage ( presenting within 96 hours of the ictus ) from 6 neurosurgical centers were recruited for 3 years .
-METHODS	The primary outcome measure was the presence of delayed ischemic deficits , and secondary outcome measures included a modified Rankin disability score at 3 months and an analysis of cost-effectiveness .
-RESULTS	No difference was observed between the groups treated with the higher dose or the lower dose of simvastatin in the incidence of delayed ischemic deficits ( 27 % versus 24 % ; odds ratio , 1.2 ; 95 % confidence interval , 0.7-2 .0 ; P = 0.586 ) or in the rate of favorable outcomes ( modified Rankin Scale score , 0-2 ) at 3 months ( 73 % versus 72 % ; odds ratio , 1.1 ; 95 % confidence interval , 0.6-1 .9 ; P = 0.770 ) .
-CONCLUSIONS	High-dose simvastatin treatment should not be prescribed routinely for aneurysmal subarachnoid hemorrhage .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT01077206 .
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-###24884753
-OBJECTIVE	We examined the cost-effectiveness of an intervention to reduce coronary heart disease ( CHD ) risk and blood pressure in African Americans .
-METHODS	Stochastic cost-effectiveness analysis alongside a clinical trial , augmented by a Markov model of lifetime cost-effectiveness .
-METHODS	In 2 urban academic primary care practices , we randomized African American patients with uncontrolled hypertension to a 6-month intervention of office practice and peer coach behavioral support ( N = 136 ) or informational brochures about CHD risk factors ( N = 144 ) .
-METHODS	Costs were estimated from the perspective of the provider .
-METHODS	Outcomes included estimated CHD events avoided over 6 months and reduction in systolic blood pressure ( SBP ) ( mm Hg ) .
-METHODS	Subgroup analysis was performed for compliers who received an `` effective '' dose of the peer coach and office staff visits .
-METHODS	Long-term cost-effectiveness was estimated by applying the clinical trial cost and effectiveness into a Markov model of CHD risk .
-RESULTS	The average cost for the behavioral support intervention group was $ 435.36 compared with $ 74.39 for the brochure control group .
-RESULTS	The incremental cost-effectiveness ratio ( ICER ) was $ 47 per mm Hg reduction in SBP and $ 453,419 per CHD event avoided in 6 months .
-RESULTS	Modeled over a 10-year horizon , the intervention had an ICER only as high as $ 3998 per incremental quality-adjusted life-year .
-CONCLUSIONS	A community-primary care practice behavioral intervention to reduce hypertension in African Americans with sustained uncontrolled hypertension does not appear to be cost-effective in the first 6 months .
-CONCLUSIONS	If intervention results are sustained over the long term , the program may be cost-effective over the patient 's lifetime .
-
-###24975869
-OBJECTIVE	Our primary objective was to determine the proportion of patients with atrial fibrillation ( AF ) eligible for enrollment in a randomized controlled trial for a novel oral anticoagulant , the ARISTOTLE trial .
-OBJECTIVE	A secondary objective was to describe the reasons for trial ineligibility .
-METHODS	We performed a cross-sectional study of an unselected population including 2274 patients in Skellefte , Sweden with at least one verified episode of AF on or before December 31 , 2010 .
-METHODS	Patients were classified as suitable or unsuitable for anticoagulant treatment according to current guidelines .
-METHODS	The enrollment criteria from the ARISTOTLE trial were extracted from the original publication and applied to the population .
-RESULTS	Among all patients with AF , 1579 were classified as suitable for anticoagulant treatment .
-RESULTS	Of these , only 658 patients ( 42 % ) were eligible for participation in the ARISTOTLE trial .
-RESULTS	Among the 921 patients ineligible for participation , 498 did not meet the ECG criteria , 272 had psychosocial problems , and in addition , 78 patients were excluded due to both of these criteria .
-CONCLUSIONS	Our study shows that a majority of the patients in an unselected population with AF suitable for anticoagulant treatment were ineligible for participation in the ARISTOTLE trial .
-CONCLUSIONS	The applicability of the ARISTOTLE trial is therefore unknown for a considerable proportion of patients with AF in real life .
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-###25380538
-OBJECTIVE	The purpose of this study was to evaluate the safety and effectiveness of 2-level total disc replacement ( TDR ) using a Mobi-C cervical artificial disc at 48 months ' follow-up .
-METHODS	A prospective randomized , US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at 24 centers in the U.S. Three hundred thirty patients with degenerative disc disease were randomized and treated with cervical total disc replacement ( 225 patients ) or the control treatment , anterior cervical discectomy and fusion ( ACDF ) ( 105 patients ) .
-METHODS	Patients were followed up at regular intervals for 4 years after surgery .
-RESULTS	At 48 months , both groups demonstrated improvement in clinical outcome measures and a comparable safety profile .
-RESULTS	Data were available for 202 TDR patients and 89 ACDF patients in calculation of the primary endpoint .
-RESULTS	TDR patients had statistically significantly greater improvement than ACDF patients for the following outcome measures compared with baseline : Neck Disability Index scores , 12-Item Short Form Health Survey Physical Component Summary scores , patient satisfaction , and overall success .
-RESULTS	ACDF patients experienced higher subsequent surgery rates and displayed a higher rate of adjacent-segment degeneration as seen on radiographs .
-RESULTS	Overall , TDR patients maintained segmental range of motion through 48 months with no device failure .
-CONCLUSIONS	Four-year results from this study continue to support TDR as a safe , effective , and statistically superior alternative to ACDF for the treatment of degenerative disc disease at 2 contiguous cervical levels .
-CONCLUSIONS	Clinical trial registration no. : NCT00389597 ( clinicaltrials.gov ) .
-
-###25491714
-OBJECTIVE	The objective of this study was to test the effect of a brief educational and counseling intervention on increasing the uptake of free testing for Chlamydia trachomatis ( chlamydia ) and Neisseria gonorrhea ( gonorrhea ) among young female emergency department ( ED ) patients .
-OBJECTIVE	Women are particularly vulnerable to more serious consequences of these infections due to asymptomatic presentation .
-OBJECTIVE	Increased testing is important to detect , treat , and halt the spread of these infections among asymptomatic women .
-METHODS	This was a randomized controlled trial .
-METHODS	Research assistants ( RAs ) approached female patients in two EDs .
-METHODS	Eligible patients were between 18 and 35 years of age , who reported having sex with males , but were not attending the ED for either treatment of sexually transmitted infection ( STI ) or testing for possible STI exposure .
-METHODS	Participants responded to survey questions about their lifetime and past 3-month substance use , number of recent sexual partners , condom use , and perception of risks for chlamydia and gonorrhea infections .
-METHODS	Following the survey , the RAs randomized participants into study control or treatment arms .
-METHODS	Each treatment arm participant received a brief educational/counseling intervention from the RA .
-METHODS	The brief intervention focused on the woman 's personal risks for chlamydia and gonorrhea and condoms attitudes and usage .
-METHODS	As the primary outcome of this study , participants were offered free urine tests for chlamydia and gonorrhea infection postintervention or post-survey completion , depending on group assignment .
-RESULTS	A total of 171 women completed the baseline assessment and were offered chlamydia and gonorrhea testing .
-RESULTS	The mean ( SD ) age was 26 ( 4.76 ) years , 18 % were Hispanic , and 12 % were Spanish-speaking only .
-RESULTS	The brief intervention that was offered to increase these women 's awareness of their STI risk did not result in increased acceptance of testing ; 48 % in the brief intervention group accepted testing ( 95 % confidence interval [ CI ] = 32 % to 64 % ) versus 36 % in the control group ( 95 % CI = 19 % to 53 % ) .
-RESULTS	In a multivariable logistic regression , only self-identifying as being Hispanic was associated with greater willingness to be tested .
-RESULTS	Of the asymptomatic women tested ( n = 71 ) , five tested positive for chlamydia .
-RESULTS	This represents a positivity rate of 7 % .
-RESULTS	There were no positive test results for gonorrhea .
-RESULTS	Women who reported high-risk factors for STI , such as younger age ( 25 years ) , having sex in the past 90 days without using condoms , identified substance use , or previous STI , were not more likely to accept the offer of chlamydia and gonorrhea testing .
-CONCLUSIONS	The brief intervention used in this study did not increase the uptake of testing for chlamydia and gonorrhea infections in this sample , in comparison to receiving no intervention .
-CONCLUSIONS	Although Hispanic women were more likely to accept chlamydia and gonorrhea testing , it is concerning that those women who report STI risk factors were not more likely to accept the offer of chlamydia and gonorrhea testing .
-CONCLUSIONS	Future research should focus on the refinement of an intervention protocol to focus on prior STI and lack of condom use to increase the uptake of testing among this high-risk group .
-
-###24557088
-BACKGROUND	Preclinical studies support the hypothesis that endogenous neuroactive steroids mediate some effects of alcohol .
-OBJECTIVE	The aim of this study was to examine the effect of dutasteride inhibition of 5-reduced neuroactive steroid production on subjective responses to alcohol in adult men .
-METHODS	Using a within-subject factorial design , 70 men completed four randomly ordered monthly sessions in which pretreatment with 4 mg dutasteride or placebo was paired with a moderate dose of alcohol ( 0.8 g/kg ) or placebo beverage .
-METHODS	The pharmacologic effect of dutasteride was measured by an assay of serum androstanediol glucuronide .
-METHODS	Self-reports of alcohol effects were obtained at 40-min intervals following alcohol administration using the Biphasic Alcohol Effects Scale ( BAES ) and the Alcohol Sensation Scale ( SS ) .
-METHODS	We used linear mixed models to examine the effects of dutasteride and alcohol on BAES and SS responses and the interaction of dutasteride with the GABRA2 alcohol dependence-associated polymorphism rs279858 .
-METHODS	We also examined whether exposure to dutasteride influenced drinking in the weeks following each laboratory session .
-RESULTS	A single 4-mg dose of dutasteride produced a 70 % reduction in androstanediol glucuronide .
-RESULTS	Dutasteride pretreatment reduced alcohol effects on the BAES sedation and SS anesthesia scales .
-RESULTS	There was no interaction of dutasteride with rs279858 .
-RESULTS	Heavy drinkers had fewer heavy drinking days during the 2 weeks following the dutasteride sessions and fewer total drinks in the first week after dutasteride .
-CONCLUSIONS	These results provide evidence that neuroactive steroids mediate some of the sedative effects of alcohol in adult men and that dutasteride may reduce drinking , presumably through its effects on neuroactive steroid concentrations .
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-###25054392
-BACKGROUND	Tapentadol prolonged release ( PR ) is effective and well tolerated for chronic osteoarthritis , low back , and diabetic peripheral neuropathic pain .
-OBJECTIVE	To evaluate the efficacy and tolerability of tapentadol PR compared with placebo and morphine controlled release ( CR ) for managing moderate to severe chronic malignant tumor-related pain .
-METHODS	Randomized-withdrawal , parallel group , active - and placebo-controlled , double-blind phase 3 study ( NCT00472303 ) .
-METHODS	Primary , secondary , and tertiary care settings in 16 countries .
-METHODS	Eligible patients ( pain intensity 5 [ 11-point numerical rating scale ] on prior analgesics ) were randomized ( 2:1 ) and titrated to their optimal dose of tapentadol PR ( 100-250 mg bid ) or morphine sulfate CR ( 40-100 mg bid ) over 2 weeks .
-METHODS	Morphine sulfate immediate release 10 mg was permitted as needed for rescue medication ( no maximum dose ) .
-METHODS	Patients who completed titration and , during the last 3 days of titration , had mean pain intensity < 5 ( based on twice-daily ratings ) and mean rescue medication use = 20 mg/day continued into a 4-week maintenance period ; patients who received morphine CR during titration continued taking morphine CR , and those who received tapentadol PR were re-randomized ( 1:1 ) to tapentadol PR or placebo bid .
-METHODS	Response during maintenance ( primary efficacy endpoint ) was defined as having : ( 1 ) completed the maintenance period , ( 2 ) a mean pain intensity < 5 during maintenance , and ( 3 ) used an average of = 20 mg/day of rescue medication during maintenance .
-METHODS	Response at the end of titration was defined similarly , with pain intensity and rescue medication averages based on the last 3 days of titration .
-RESULTS	Of 622 patients screened , 496 were randomized , treated during titration , and evaluable for safety ; 327 were re-randomized , treated during maintenance , and evaluable for safety ; and 325 were evaluable for efficacy .
-RESULTS	The adjusted responder rate estimate during maintenance ( logistic regression adjusting for treatment group , pooled center , and pain intensity at start of maintenance ) was significantly higher with tapentadol PR ( 64.3 % ) than with placebo ( 47.1 % ; odds ratio ( OR ) , 2.02 [ 95 % confidence interval ( CI ) , 1.12 - 3.65 ] ; P = 0.02 ) .
-RESULTS	Based on responder rates at the end of titration , tapentadol PR ( 76.0 % [ 174/229 ] ) was non-inferior to morphine CR ( 83.0 % [ 83/100 ] ) .
-RESULTS	The lower limit of the 95 % CI for the between-groups difference ( -15.5 % ) was within the pre-specified 20 % non-inferiority margin .
-RESULTS	During titration , incidences of treatment-emergent adverse events ( TEAEs ) were 50.0 % ( 169/338 ) with tapentadol PR and 63.9 % ( 101/158 ) with morphine CR ; incidences of nausea , vomiting , and dry mouth were lower with tapentadol PR than with morphine CR .
-RESULTS	During maintenance , incidences of TEAEs were 56.3 % ( 63/112 ) , 62.3 % ( 66/106 ) , and 62.4 % ( 68/109 ) with placebo , tapentadol PR , and morphine CR , respectively .
-CONCLUSIONS	Statistical comparisons between tapentadol PR and morphine CR were limited to descriptive statistics during the maintenance period because of the pre-selection of responders to tapentadol PR or morphine CR during titration .
-CONCLUSIONS	Results obtained during maintenance indicate that tapentadol PR ( 100-250 mg bid ) is effective compared with placebo for managing moderate to severe chronic malignant tumor-related pain .
-CONCLUSIONS	Based on results obtained during titration , tapentadol PR provides comparable efficacy to that of morphine sulfate CR ( 40-100 mg bid ) , but is associated with better gastrointestinal tolerability .
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-###25188774
-OBJECTIVE	The aim of this study was to determine the effect of a single dose of 150g of clonidine as an adjuvant to levobupivacaine ( Chirocaine ( ) ) in retrobulbar block on postoperative safety and analgesia .
-METHODS	This was a prospective , randomized , controlled , double-blind trial .
-METHODS	One hundred twenty patients with a rhegmatogenous retinal detachment scheduled to undergo external buckling surgery and cryocoagulation were asked to participate .
-METHODS	Participants were randomly assigned either to receive 3-5mL Chirocaine ( 22.5-37 .5 mg ) or 3-5mL Chirocaine and 1mL clonidine ( 150g ) before surgery .
-METHODS	Main outcome measures were postoperative pain , use of analgesics , blood pressure , and plasma clonidine concentration .
-METHODS	Nine nonrandomized patients consented to give blood samples for pharmacokinetic analysis .
-RESULTS	There was no significant difference in pain score between both groups .
-RESULTS	On average , the use of analgesic medication occurred later in the clonidine group ( P = 0.0004 ) , but there was no statistical difference in the first time that postoperative medication was taken ( P = 0.13 ) .
-RESULTS	Blood pressure was reduced by clonidine ( systolic : P = 0.02 , diastolic : P = 0.006 ) .
-RESULTS	Clonidine levels could be demonstrated during the 24-h postoperative period , with an average half-life of 22h .
-CONCLUSIONS	Administration of clonidine as an adjuvant to conventional retrobulbar block is safe , and delays the postoperative use of analgesics .
-CONCLUSIONS	The reduction of postoperative pain and the time of first use of analgesic medication , however , were not significantly different between groups .
-CONCLUSIONS	Further , pain scores in both study groups remained low .
-CONCLUSIONS	Therefore , the beneficial effect of clonidine in conventional scleral buckle surgery appears to be limited .
-
-###25560820
-OBJECTIVE	Osteoporosis is a skeletal disorder characterized by impaired bone turnover and compromised bone strength , thereby predisposing to increased risk of fracture .
-OBJECTIVE	Preclinical research has shown that compounds produced by the olive tree ( Olea europaea ) , may protect from bone loss , by increasing osteoblast activity at the expense of adipocyte formation .
-OBJECTIVE	The aim of this exploratory study was to obtain a first insight on the effect of intake of an olive extract on bone turnover in postmenopausal women with decreased bone mass ( osteopenia ) .
-METHODS	For that , a double blind , placebo-controlled study was performed in which participants were randomly allocated to either treatment or placebo groups .
-METHODS	64 osteopenic patients , with a mean bone mineral density ( BMD ) T-score between -1.5 and -2.5 in the lumbar spine ( L2-L4 ) were included in the study .
-METHODS	PARTICIPANTS received for 12 months daily either 250 mg/day of olive extract and 1000 mg Ca ( treatment ) or 1000 mg Ca alone ( placebo ) .
-METHODS	Primary endpoints consisted of evaluation of bone turnover markers .
-METHODS	Secondary endpoints included BMD measurements and blood lipid profiles .
-RESULTS	After 12 months , the levels of the pro-osteoblastic marker osteocalcin were found to significantly increase in the treatment group as compared to placebo .
-RESULTS	Simultaneously , BMD decreased in the placebo group , while remaining stable in the treatment group .
-RESULTS	In addition , improved lipid profiles were observed , with significant decrease in total - and LDL-cholesterol in the treatment group .
-CONCLUSIONS	This exploratory study supports preclinical observations and warrants further research by showing that a specific olive polyphenol extract ( Bonolive ) affects serum osteocalcin levels and may stabilize lumbar spine BMD .
-CONCLUSIONS	Moreover , the improved blood lipid profiles suggest additional health benefits associated to the intake of the olive polyphenol extract .
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-###25260762
-BACKGROUND	Recruitment is a challenge in developing population-representative pregnancy and birth cohorts .
-METHODS	We developed a collaborative recruitment infrastructure ( CRI ) to recruit pregnant women for 4 pregnancy cohorts using : faxes from obstetrical offices , in-clinic recruiters , university and funder-driven free-media events , paid-media , and attendance at relevant tradeshows .
-METHODS	Recruitment rates and demographic differences were compared between recruitment methods .
-RESULTS	We received 5008 referrals over 40 months .
-RESULTS	Compared to fax , free-media referrals were 13 times more likely to be recruited ( OR 13.0 , 95 % CI 4.2 , 40.4 : p < 0.001 ) and paid-media referrals were 4 times more likely to be recruited ( OR 4.6 , 95 % CI 2.1 , 10.3 : p < 0.001 ) .
-RESULTS	Among paid-media advertisements , free-to-read print ( e.g. Metro ) was the most effective ( OR 3.3 , 95 % CI 2.3 , 4.5 : p < 0.05 ) .
-RESULTS	Several demographic differences were identified between recruitment methods and against a reference population .
-RESULTS	Between recruitment methods , media recruits had a similar proportion families with incomes $ 40,000 ( paid-media : 94.4 % ; free-media : 93.3 % ) compared to fax recruits ( 95.7 % ) , while in-clinic recruits were less likely to have family incomes $ 40,000 ( 88.8 % , p < 0.05 ) .
-RESULTS	Maternal recruits from fax and in-clinic were more likely to attend university ( Fax : 92.6 % , in-clinic 89.8 % ) versus the reference population ( 52.0 % ; p < 0.05 for both ) and both were less likely to smoke ( Fax : 6.8 % , in-clinic 4.2 % ) versus reference ( 18.6 % ; p < 0.05 for both ) .
-RESULTS	However , while fax referrals were more likely to be Caucasian ( 85.9 % versus reference 77.5 % ; p < 0.05 ) , in-clinic referrals were not significantly different ( 78.2 % ; P > 0.05 ) .
-CONCLUSIONS	Recruitment methods result in different recruitment rates and participant demographics .
-CONCLUSIONS	A variety of methods are required to recruit a generalizable sample .
-
-###25064019
-BACKGROUND	Research on contingency management to treat excessive alcohol use is limited due to feasibility issues with monitoring adherence .
-BACKGROUND	This study examined the effectiveness of using transdermal alcohol monitoring as a continuous measure of alcohol use to implement financial contingencies to reduce heavy drinking .
-METHODS	Twenty-six male and female drinkers ( from 21 to 39 years old ) were recruited from the community .
-METHODS	Participants were randomly assigned to one of the two treatment sequences .
-METHODS	Sequence 1 received 4 weeks of no financial contingency ( i.e. , $ 0 ) drinking followed by 4 weeks each of $ 25 and then $ 50 contingency management ; Sequence 2 received 4 weeks of $ 25 contingency management followed by 4 weeks each of no contingency ( i.e. , $ 0 ) and then $ 50 contingency management .
-METHODS	During the $ 25 and $ 50 contingency management conditions , participants were paid each week when the Secure Continuous Remote Alcohol Monitor ( SCRAM-II ) identified no heavy drinking days .
-RESULTS	Participants in both contingency management conditions had fewer drinking episodes and reduced frequencies of heavy drinking compared to the $ 0 condition .
-RESULTS	Participants randomized to Sequence 2 ( receiving $ 25 contingency before the $ 0 condition ) exhibited less frequent drinking and less heavy drinking in the $ 0 condition compared to participants from Sequence 1 .
-CONCLUSIONS	Transdermal alcohol monitoring can be used to implement contingency management programs to reduce excessive alcohol consumption .
-
-###26194675
-OBJECTIVE	In the European HIT-SIOP PNET4 randomized controlled trial , children with standard risk medulloblastoma were allocated to hyperfractionated radiation therapy ( HFRT arm , including a partially focused boost ) or standard radiation therapy ( STRT arm ) , followed , in both arms , by maintenance chemotherapy .
-OBJECTIVE	Event-free survival was similar in both arms .
-OBJECTIVE	Previous work showed that the HFRT arm was associated with worse growth and better questionnaire-based executive function , especially in children < 8years of age at diagnosis .
-OBJECTIVE	Therefore , the aim of this study was to compare performance-based cognitive outcomes between treatment arms .
-METHODS	Neuropsychological data were collected prospectively in 137 patients .
-METHODS	Using the Wechsler Intelligence Scales , Kaufman Assessment Battery for Children , and Raven 's Progressive Matrices , we estimated full-scale intelligence quotient ( FSIQ ) and , when available , verbal IQ ( VIQ ) , performance IQ ( PIQ ) , working memory index ( WMI ) , and processing speed index ( PSI ) .
-RESULTS	Among the 137 participants ( HFRT arm n = 71 , STRT arm n = 66 , 63.5 % males ) , mean ( SD ) ages at diagnosis and assessment respectively were 9.3 ( 3.2 ) years of age ( 40.8 % < 8years of age at diagnosis ) and 14.6 ( 4.3 ) years of age .
-RESULTS	Mean ( SD ) FSIQ was 88 ( 19 ) , and mean intergroup difference was 3.88 ( 95 % confidence interval : -2.66 to 10.42 , P = .24 ) .
-RESULTS	No significant differences were found in children > 8years of age at diagnosis .
-RESULTS	In children < 8years of age at diagnosis , a marginally significant trend toward higher VIQ was found in those treated in the HFRT arm ; a similar trend was found for PSI but not for PIQ , WMI , or FSIQ ( mean intergroup differences were : 12.02 for VIQ [ 95 % CI : 2.37-21 .67 ; P = .02 ] ; 3.77 for PIQ [ 95 % CI : -5.19 to 12.74 ; P > .10 ] ; 5.20 for WMI [ 95 % CI : -2.07 to 12.47 ; P > .10 ] ; 10.90 for PSI [ 95 % CI : -1.54 to 23.36 ; P = .08 ] ; and 5.28 for FSIQ [ 95 % CI : -4.23 to 14.79 ; P > .10 ] ) .
-CONCLUSIONS	HFRT was associated with marginally higher VIQ in children < 8years of age at diagnosis , consistent with a previous report using questionnaire-based data .
-CONCLUSIONS	However , overall cognitive ability was not significantly different .
-
-###24628437
-OBJECTIVE	Compare the treatment outcome after scaling and root-planing using local anesthesia gel or injected local anesthesia .
-METHODS	Thirty-eight patients with periodontitis and good general health were included in a randomized , single-blind , split-mouth clinical trial .
-METHODS	Probing depths and clinical attachment levels were recorded at baseline and 6weeks after treatment .
-METHODS	Performed treatment procedures were scaling and root planing using two types of local anesthesia for separate treatment appointments .
-METHODS	Anesthetics used were intra-pocket lidocaine and prilocaine gel ( 2.5 % each ) and injected articaine ( 1:100,000 adrenaline ) .
-METHODS	Type of anesthesia for first appointment was randomized and switched for second appointment .
-METHODS	Patients ' pain perception and anesthesia acceptance were recorded on questionnaires .
-RESULTS	No influence of applied type of anesthesia could be detected for change of probing pocket depths and clinical attachment level ( p > 0.05 ) .
-RESULTS	These findings are valid even for deeper pockets .
-RESULTS	Gel-group had significant higher intra-operative pain perception .
-RESULTS	In retrospect 69 % of patients favored gel .
-CONCLUSIONS	Treatment outcome is not compromised by use of anesthesia gel in comparison to injected anesthesia .
-CONCLUSIONS	The same beneficial results for probing pocket depths and clinical attachment gain could be detected .
-CONCLUSIONS	The majority of patients prefer local anesthesia gel despite a slightly greater procedural discomfort .
-
-###24548447
-OBJECTIVE	To explore the clinical values of detecting drug related molecules excision repair cross complementing 1 ( ERCC1 ) and top-isomerase I ( TOPO I ) in individualized therapies of metastatic colorectal cancer .
-METHODS	From June 2009 to December 2011 , 90 patients at Huadong Hospital with metastatic colorectal cancer were randomly separated into 2 groups after operation .
-METHODS	Each group had 45 patients without difference in gender , age or TNM stage .
-METHODS	The expressions of ERCC1 and TOPO Iin cancer tissues were detected by immunohistochemical staining .
-METHODS	The testing group received individualized chemotherapies following the expression results while the control group had random chemotherapies .
-METHODS	The survival difference between two groups was analyzed by log-rank test and Kaplan-Meier analysis .
-METHODS	And curative effect was analyzed by ( 2 ) or Fisher 's analysis .
-RESULTS	The expressions of ERCC1 and TOPO I had no statistical significance between two groups ( both P > 0.05 ) .
-RESULTS	In the testing group , the median survival time was 281 days and the beneficial ratio 51.1 % ( 23/45 ) versus 246 days and 44.4 % ( 20/45 ) respectively in the control group .
-RESULTS	The inter-group comparisons of survival ( P = 0.235 ) and curative effect ( ( 2 ) = 0.04 , P > 0.05 ) showed no statistical significance .
-RESULTS	In the estimated drug tolerated group ( ERCC1 high expression or TOPO I low expression ) , the median survival time was 196 days and the beneficial ratio 4/14 versus 304 days and 51.3 % ( 39/76 ) in the estimated drug sensitive group .
-RESULTS	The inter-group comparisons of survival and curative effect ( both P < 0.05 ) had statistical significance .
-RESULTS	The median survival time and beneficial ratio significantly increased in estimated drug sensitive group than those in estimated drug tolerated group .
-CONCLUSIONS	The expression of drug related molecule in colorectal cancer tissue is significantly associated with curative effect in patients .
-CONCLUSIONS	Patients with down-regulated ERCC1 on Oxaliplatin or up-regulated TOPO Ion Irinotecan have longer survival and better curative effect .
-CONCLUSIONS	And chemotherapies guided by drug related molecule detection may boost curative effects in metastatic colorectal cancer .
-
-###25411159
-BACKGROUND	Biodegradable-polymer drug-eluting stents ( BP-DES ) were developed to be as effective as second-generation durable-polymer drug-eluting stents ( DP-DES ) and as safe > 1 year as bare-metal stents ( BMS ) .
-BACKGROUND	Thus , very late stent thrombosis ( VLST ) attributable to durable polymers should no longer appear .
-RESULTS	To address these early and late aspects , 2291 patients presenting with acute or stable coronary disease needing stents 3.0 mm in diameter between April 2010 and May 2012 were randomly assigned to biolimus-A9-eluting BP-DES , second-generation everolimus-eluting DP-DES , or thin-strut silicon-carbide-coated BMS in 8 European centers .
-RESULTS	All patients were treated with aspirin and risk-adjusted doses of prasugrel .
-RESULTS	The primary end point was combined cardiac death , myocardial infarction , and clinically indicated target-vessel revascularization within 2 years .
-RESULTS	The combined secondary safety end point was a composite of VLST , myocardial infarction , and cardiac death .
-RESULTS	The cumulative incidence of the primary end point was 7.6 % with BP-DES , 6.8 % with DP-DES , and 12.7 % with BMS .
-RESULTS	By intention-to-treat BP-DES were noninferior ( predefined margin , 3.80 % ) compared with DP-DES ( absolute risk difference , 0.78 % ; -1.93 % to 3.50 % ; P for noninferiority 0.042 ; per protocol P = 0.09 ) and superior to BMS ( absolute risk difference , -5.16 ; -8.32 to -2.01 ; P = 0.0011 ) .
-RESULTS	The 3 stent groups did not differ in the combined safety end point , with no decrease in events > 1 year , particularly VLST with BP-DES .
-CONCLUSIONS	In large vessel stenting , BP-DES appeared barely noninferior compared with DP-DES and more effective than thin-strut BMS , but without evidence for better safety nor lower VLST rates > 1 year .
-CONCLUSIONS	Findings challenge the concept that durable polymers are key in VLST formation .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT01166685 .
-
-###25136048
-BACKGROUND	The World Health Organization recommends vitamin A supplementation ( VAS ) at routine vaccination contacts after 6 months of age based on the assumption that it reduces mortality by 24 % .
-BACKGROUND	The policy has never been evaluated in randomized controlled trials for its effect on overall mortality .
-BACKGROUND	We conducted a randomized double-blind trial to evaluate the effect of VAS with vaccines .
-METHODS	We randomized children aged 6 to 23 months 1:1 to VAS ( 100000 IU if aged 6-11 months , 200000 IU if aged 12-23 months ) or placebo at vaccination contacts in Guinea-Bissau .
-METHODS	Mortality rates were compared in Cox proportional-hazards models overall , and by gender and vaccine .
-RESULTS	Between August 2007 and November 2010 , 7587 children were enrolled .
-RESULTS	Within 6 months of follow-up 80 nonaccident deaths occurred ( VAS : 38 ; placebo : 42 ) .
-RESULTS	The mortality rate ratio ( MRR ) comparing VAS versus placebo recipients was 0.91 ( 95 % confidence interval 0.59-1 .41 ) and differed significantly between boys ( MRR 1.92 [ 0.98-3 .75 ] ) and girls ( MRR 0.45 [ 0.24-0 .87 ] ) ( P = .003 for interaction between VAS and gender ) .
-RESULTS	At enrollment , 42 % ( 3161/7587 ) received live measles vaccine , 29 % ( 2154/7587 ) received inactivated diphtheria-tetanus-pertussis-containing vaccines , and 21 % ( 1610/7587 ) received both live and inactivated vaccines .
-RESULTS	The effect of VAS did not differ by vaccine group .
-CONCLUSIONS	This is the first randomized controlled trial to assess the effect of the policy on overall mortality .
-CONCLUSIONS	VAS had no overall effect , but the effect differed significantly by gender .
-CONCLUSIONS	More trials to ensure an optimal evidence-based vitamin A policy are warranted .
-
-###24565243
-OBJECTIVE	Sedation-analgesia is recommended for comfortable colonoscopy procedures , which are invasive and can be painful .
-OBJECTIVE	This study aimed to compare the combinations of propofol-alfentanil and propofol-fentanyl for sedation-analgesia in elective colonoscopy patients .
-METHODS	This prospective and randomized study was planned in ASA I-II groups and included 80 patients between the ages of 18 and 65 years .
-METHODS	Sedation-analgesia induction was performed as 1 g.kg ( -1 ) fentanyl , 1mg .
-METHODS	kg ( -1 ) propofol in the propofol-fentanyl group ( Group PF ) and 10 g.kg ( -1 ) alfentanil , 1mg .
-METHODS	kg ( -1 ) propofol in the propofol-alfentanil group ( Group PA ) .
-METHODS	Patients ' scores were limited to 3-4 values on the Ramsey Sedation Scale ( RSS ) by 0.5 mg.kg ( -1 ) bolus additional doses of propofol in sedation-analgesia maintenance .
-METHODS	We recorded demographical data , heart rate , mean arterial pressure ( MAP ) , oxygen saturation of hemoglobin ( SpO2 ) , RSS value , colonoscopy time , total dose of propofol , complications , recovery time , and discharge time , as well as colonoscopist and patient satisfaction scores .
-RESULTS	MAP at the 15 ( th ) minute in Group PA was significantly higher than in Group PF ( p = 0.037 ) .
-RESULTS	Group PA 's beginning mean heart rate was higher than the mean heart rate at subsequent readings ( p = 0.012 , p = 0.002 ) .
-RESULTS	The mean total propofol dose of Group PA was significantly higher than the total dose of Group PF ( p = 0.028 ) .
-RESULTS	The mean recovery time of Group PA was significantly longer than that of Group PF ( p = 0.032 ) .
-CONCLUSIONS	Fentanyl provides better operative conditions and reduces the need for additional propofol doses .
-CONCLUSIONS	These advantages cause a shorter recovery time .
-CONCLUSIONS	Therefore , propofol-fentanyl is superior to the propofol-alfentanil for sedation-analgesia in colonoscopy .
-
-###24494737
-OBJECTIVE	To investigate the immediate effects of manipulation of bilateral sacroiliac joints ( SIJs ) on the plantar pressure distribution in asymptomatic participants in the standing position .
-METHODS	Randomized , controlled , double-blind clinical trial .
-METHODS	Sixty-two asymptomatic men and women ( mean age , 20.662.56 years ) randomly assigned to 2 groups .
-METHODS	The experimental group underwent mobilization without tension of the hips in the supine position and high-velocity , low-amplitude manipulation in the SIJs bilaterally .
-METHODS	The control group underwent only mobilization , without tension of the hips in supine position .
-METHODS	Pre - and postintervention outcomes measured by an assessor blinded to the treatment allocation of the participants included a baropodometric analysis performed by using a force platform .
-METHODS	Baseline between-group differences were examined with a Kolmogorov-Smirnov test .
-METHODS	A chi-square test was used for categorical data .
-METHODS	Analysis of covariance ( ANCOVA ) was used to assess differences between groups , with the preintervention value as covariant ( 95 % confidence level ) .
-RESULTS	At baseline , no variables significantly differed between groups .
-RESULTS	Baropodometric analysis showed statistically significant differences in the location of the maximum pressure point in the experimental group ( p = 0.028 ) .
-RESULTS	Pre - and postintervention analysis with ANCOVA showed statistically significant differences between both groups in the left hindfoot load percentage ( interaction p = 0.0259 ; ANCOVA p = 0.0277 ) , right foot load percentage ( ANCOVA p = 0.0380 ) , and surface of the right forefoot ( interaction p = 0.0038 ) .
-RESULTS	There was also a significant effect in the variables that analyze the entire foot ( left foot : surface [ interaction p = 0.0452 ] , percentage of load [ ANCOVA p = 0.0295 ] ) and between both groups ( right foot : weight [ interaction p = 0.0070 ; ANCOVA p = 0.0296 ] ) .
-CONCLUSIONS	Sacroiliac joint manipulation applied bilaterally in asymptomatic persons resulted in immediate changes in load distribution on plantar support in the standing position .
-CONCLUSIONS	Study limitations and suggestions for future studies are discussed .
-
-###24452849
-BACKGROUND	New-onset diabetes after transplantation ( NODAT ) is a common complication after renal transplantation .
-BACKGROUND	There are limited available oral drugs to treat hyperglycaemia in this population owing to reduced renal function , potential interactions with immunosuppressive drugs and adverse effects such as hypoglycaemic events that may increase the cardiovascular risk .
-BACKGROUND	This study was initiated to investigate efficacy and safety of sitagliptin treatment that may represent a novel alternative in renal transplant recipients .
-METHODS	Nineteen long-term stable renal transplant recipients with NODAT were included in a controlled , cross-over study and randomized to first receive either sitagliptin 50-100 mg/day or a sitagliptin-free period of 4 weeks .
-METHODS	Median age ( interquartile range , IQR ) was 67 ( 62-72 ) years ( 12 males/7 females ) , all studied 1 ( 1-3 ) year after transplantation .
-METHODS	The immunosuppressive regimen was a triple calcineurin inhibitor-based therapy .
-METHODS	Oral glucose tolerance test ( OGTT ) with insulin and C-peptide responses and laser Doppler ( LD ) flowmetry assessment of endothelial function were performed at baseline and after each treatment period .
-METHODS	Home measurements of plasma glucose were performed daily during the study .
-RESULTS	The median ( IQR ) first - and second-phase insulin secretion responses increased significantly by 56.3 % ( 45.2-112 .6 % , P = 0.005 ) and 39.3 % ( 26.5-81 .0 % , P = 0.006 ) , respectively , following sitagliptin treatment as compared with no sitagliptin treatment .
-RESULTS	Fasting and 2-h plasma glucose concentrations fell significantly { 0.9 mmol/L [ 0.5-1 .7 mmol/L ( 16.2 mg/dL ) , P = 0.003 ] and 2.9 mmol/L [ 0.5-6 .4 mmol/L ( 52.3 mg/dL ) , P = 0.004 ] , respectively } , as did also home measurements of plasma glucose .
-RESULTS	Endothelial function and plasma markers of cardiovascular risk were unaffected .
-RESULTS	No serious adverse events were observed .
-RESULTS	Two mild and asymptomatic hypoglycaemic episodes were observed in combination with glipizide .
-CONCLUSIONS	Sitagliptin increases insulin secretion and reduces fasting and postprandial plasma glucose in renal transplant recipients with NODAT .
-CONCLUSIONS	The short-term treatment was well tolerated , and sitagliptin seems safe in this population .
-
-###24393424
-BACKGROUND	Sepsis , a leading cause of death in critically ill patients , is the result of complex interactions between the infecting microorganisms and the host responses that influence clinical outcomes .
-BACKGROUND	We evaluated the prognostic value of presepsin ( sCD14-ST ) , a novel biomarker of bacterial infection , and compared it with procalcitonin ( PCT ) .
-METHODS	This is a retrospective , case-control study of a multicenter , randomized clinical trial enrolling patients with severe sepsis or septic shock in ICUs in Italy .
-METHODS	We selected 50 survivors and 50 non-survivors at ICU discharge , matched for age , sex and time from sepsis diagnosis to enrollment .
-METHODS	Plasma samples were collected 1 , 2 and 7 days after enrollment to assay presepsin and PCT .
-METHODS	Outcome was assessed 28 and 90 days after enrollment .
-RESULTS	Early presepsin ( day 1 ) was higher in decedents ( 2,269 pg/ml , median ( Q1 to Q3 ) , 1,171 to 4,300 pg/ml ) than in survivors ( 1,184 pg/ml ( median , 875 to 2,113 ) ; P = 0.002 ) , whereas PCT was not different ( 18.5 g/L ( median 3.4 to 45.2 ) and 10.8 g/L ( 2.7 to 41.9 ) ; P = 0.31 ) .
-RESULTS	The evolution of presepsin levels over time was significantly different in survivors compared to decedents ( P for time-survival interaction = 0.03 ) , whereas PCT decreased similarly in the two groups ( P = 0.13 ) .
-RESULTS	Presepsin was the only variable independently associated with ICU and 28-day mortality in Cox models adjusted for clinical characteristics .
-RESULTS	It showed better prognostic accuracy than PCT in the range of Sequential Organ Failure Assessment score ( area under the curve ( AUC ) from 0.64 to 0.75 vs. AUC 0.53 to 0.65 ) .
-CONCLUSIONS	In this multicenter clinical trial , we provide the first evidence that presepsin measurements may have useful prognostic information for patients with severe sepsis or septic shock .
-CONCLUSIONS	These preliminary findings suggest that presepsin may be of clinical importance for early risk stratification .
-
-###25600720
-OBJECTIVE	To compare the efficacy of celecoxib for treatment of withdrawal headache vs prednisone in patients with medication overuse headache ( MOH ) .
-METHODS	In this prospective , double-blind , parallel-group clinical trial , 97 consecutive subjects with MOH were randomized ( simple randomization using computer-generated numbers ) for treatment with either 400mg/day celecoxib ( for the first 5 days then decreased at a rate of 100mg every 5 days ) or prednisone 75 mg/day orally ( for the first 5 days then tapered off every 5 days ) .
-METHODS	Subjects who met the International Headache Society criteria for MOH were included in the trial .
-METHODS	The change in headache days and intake of rescue medication were considered as primary outcomes while the change in headache severity defined as a secondary outcome .
-RESULTS	Patients treated with celecoxib experienced lower headache intensity during the first 3 weeks after withdrawal ( after 3 weeks , the median of visual analog scale was 3 for patients in celecoxib group vs 4.5 for prednisone group [ P < .001 ] ) .
-RESULTS	However , headache frequency and the need for rescue medication intake were not different between 2 groups .
-CONCLUSIONS	During withdrawal in MOH , in order to reduce headache days or rescue medication intake , using either of celecoxib or prednisone as a bridge is not different .
-
-###25280410
-OBJECTIVE	Short-term dietary glucose supplementation has been shown to accelerate the gastric emptying rate of both glucose and fructose solutions .
-OBJECTIVE	The aim of this study was to examine gastric emptying rate responses to monosaccharide ingestion following short-term dietary fructose supplementation .
-METHODS	The gastric emptying rate of a fructose solution containing 36 g of fructose and an equicaloric glucose solution containing 39.6 g glucose monohydrate were measured in 10 healthy non-smoking men with and without prior fructose supplementation ( water control ) using a randomized crossover design .
-METHODS	Gastric emptying rate was assessed for a period of 1 h using the [ ( 13 ) C ] breath test with sample collections at baseline and 10-min intervals following drink ingestion .
-METHODS	Additionally , appetite ratings of hunger , fullness , and prospective food consumption were recorded at baseline and every 10 min using visual analog scales .
-RESULTS	Increased dietary fructose ingestion resulted in significantly accelerated half-emptying time of a fructose solution ( mean = 48 , SD = 6 versus 58 , SD = 14 min control ; P = 0.037 ) , whereas the emptying of a glucose solution remained unchanged ( mean = 85 , SD = 31 versus 78 , SD = 27 min control ; P = 0.273 ) .
-RESULTS	Time of maximal emptying rate of fructose was also significantly accelerated following increased dietary fructose intake ( mean = 33 , SD = 6 versus 38 , SD = 9 min control ; P = 0.042 ) , while it remained unchanged for glucose ( mean = 45 , SD = 14 versus 44 , SD = 14 min control ; P = 0.757 ) .
-RESULTS	No effects of supplementation were observed for appetite measures .
-CONCLUSIONS	Three d of supplementation with 120 g/d of fructose resulted in an acceleration of gastric emptying rate of a fructose solution but not a glucose solution .
-
-###26248345
-OBJECTIVE	To evaluate intraocular lens ( IOL ) axial movements and refractive changes during a 6-month follow-up period after femtosecond laser-assisted cataract surgery and conventional cataract surgery , investigate the influence of capsulorhexis features on postoperative IOL axial changes , and assess the prediction error for both techniques .
-METHODS	Eighty eyes of 80 candidates for cataract extraction were randomized into two groups : femtosecond laser ( 40 eyes ) and manual ( 40 eyes ) .
-RESULTS	The overall anterior chamber depth variation was significantly lower in the femtosecond laser group compared to the manual group during follow-up ( P < .001 ) .
-RESULTS	At 30 and 180 days postoperatively , the mean spherical equivalent showed a hyperopic shift ( 0.090.28 diopters [ D ] ) in the femtosecond laser group and a myopic shift in the manual group ( -0.250.18 D ) .
-RESULTS	Median absolute error was not significantly different between the two groups with standard formulas ranging between 0.29 and 0.64 ( Hoffer Q ) in the femtosecond laser group and between 0.24 ( SRK-T ) and 0.55 D ( Hoffer Q ) in the manual group .
-RESULTS	There was a significant lower deviation from intended versus achieved capsulotomy/capsulorhexis area in the femtosecond laser group ( P < .001 ) compared to the manual group .
-RESULTS	The femtosecond laser group showed better IOL centration compared to the manual group at all time periods ( P < .001 ) .
-CONCLUSIONS	Femtosecond laser-assisted cataract surgery was related to a lower overall variability of anterior chamber depth compared to conventional cataract surgery with more stable postoperative refraction .
-CONCLUSIONS	The two techniques did not show significant differences of prediction error .
-
-###24337154
-OBJECTIVE	Insulin-sensitive tissues ( muscle , liver ) of individuals with obesity and type 2 diabetes mellitus are in a state of low-grade inflammation , characterised by increased Toll-like receptor ( TLR ) expression and TLR-driven signalling .
-OBJECTIVE	However , the cause of this mild inflammatory state is unclear .
-OBJECTIVE	We tested the hypothesis that a prolonged mild increase in plasma NEFA will increase TLR expression and TLR-driven signalling ( nuclear factor B [ NFB ] and mitogen-activated kinase [ MAPK ] ) and impair insulin action in muscle of lean healthy individuals .
-METHODS	Twelve lean , normal-glucose-tolerant participants were randomised to receive a 48 h infusion ( 30 ml/h ) of saline or Intralipid followed by a euglycaemic-hyperinsulinaemic clamp .
-METHODS	Vastus lateralis muscle biopsies were performed before and during the clamp .
-RESULTS	Lipid infusion impaired insulin-stimulated IRS-1 tyrosine phosphorylation and reduced peripheral insulin sensitivity ( p < 0.01 ) .
-RESULTS	The elevation in circulating NEFA increased expression of TLR3 , TLR4 and TLR5 , and several MAPK ( MAPK8 , MAP4K4 , MAP2K3 ) and inhibitor of B kinase-NFB ( CHUK [ IKKA ] , c-REL [ REL ] and p65 [ RELA , NFKB3 , p65 ] ) signalling genes ( p < 0.05 ) .
-RESULTS	The lipid infusion also increased extracellular signal-regulated kinase ( ERK ) phosphorylation ( p < 0.05 ) and tended to reduce the content of inhibitor of kappa B ( p = 0.09 ) .
-RESULTS	The muscle content of most diacylglycerol , ceramide and acylcarnitine species was unaffected .
-RESULTS	In summary , insulin resistance induced by prolonged low-dose lipid infusion occurs together with increased TLR-driven inflammatory signalling and impaired insulin-stimulated IRS-1 tyrosine phosphorylation .
-CONCLUSIONS	A sustained , mild elevation in plasma NEFA is sufficient to increase TLR expression and TLR-driven signalling ( NFB and MAPK ) in lean individuals .
-CONCLUSIONS	The activation of this pathway by NEFA may be involved in the pathogenesis of insulin resistance in humans .
-BACKGROUND	ClinicalTrials.gov NCT01740817 .
-
-###24856939
-OBJECTIVE	In children with cerebral palsy , does a 6-month physical activity stimulation program improve physical activity , mobility capacity , fitness , fatigue and attitude towards sports more than usual paediatric physiotherapy ?
-METHODS	Multicentre randomised controlled trial with concealed allocation , blinded assessments and intention-to-treat analysis .
-METHODS	Forty-nine walking children ( 28 males ) aged 7-13 years with spastic cerebral palsy and severity of the disability classified as Gross Motor Function Classification System level I-III .
-METHODS	The intervention group followed a 6-month physical activity stimulation program involving counselling through motivational interviewing , home-based physiotherapy , and 4 months of fitness training .
-METHODS	The control group continued their usual paediatric physiotherapy .
-METHODS	Primary outcomes were walking activity ( assessed objectively with an activity monitor ) and parent-reported physical activity ( Activity QUESTIONnaire for Adults and Adolescents ) .
-METHODS	Secondary outcomes were : mobility capacity , consisting of Gross Motor Function Measure-66 ( GMFM-66 ) , walking capacity and functional strength , fitness ( aerobic and anaerobic capacity , muscle strength ) , self-reported fatigue , and attitude towards sport ( child and parent ) .
-METHODS	Assessments were performed at baseline , 4 months , 6 months and 12 months .
-RESULTS	There were no significant intervention effects for physical activity or secondary outcomes at any assessment time .
-RESULTS	Positive trends were found for parent-reported time at moderate-to-vigorous intensity ( between-group change ratio = 2.2 , 95 % CI 1.1 to 4.4 ) and GMFM-66 ( mean between-group difference = 2.8 points , 95 % CI 0.2 to 5.4 ) at 6 months , but not at 12 months .
-RESULTS	There was a trend for a small , but clinically irrelevant , improvement in the children 's attitudes towards the disadvantages of sports at 6 months , and towards the advantages of sports at 12 months .
-CONCLUSIONS	This physical activity stimulation program , that combined fitness training , counselling and home-based therapy , was not effective in children with cerebral palsy .
-CONCLUSIONS	Further research should examine the potential of each component of the intervention for improving physical activity in this population .
-BACKGROUND	NTR2099 .
-
-###25298165
-OBJECTIVE	To evaluate glucose-lowering treatment strategies with linagliptin and metformin in people with newly diagnosed type 2 diabetes and marked hyperglycaemia , a prevalent population for which few dedicated studies of oral antidiabetes drugs have been conducted .
-METHODS	A total of 316 patients , with type 2 diabetes diagnosed for 12months and with glycated haemoglobin ( HbA1c ) concentration in the range 8.5-12 .0 % , were randomized 1:1 to double-blind , free-combination treatment with linagliptin 5mg once daily and metformin twice daily ( uptitrated to 2000mg/day maximum ) or to linagliptin monotherapy .
-METHODS	The primary endpoint was change in HbA1c concentration from baseline at week 24 ( per-protocol completers ' cohort : n = 245 ) .
-RESULTS	The mean ( standard deviation ) age and HbA1c at baseline were 48.8 ( 11.0 ) years and 9.8 ( 1.1 ) % , respectively .
-RESULTS	At week 24 , the meanstandard error ( s.e. ) HbA1c decreased from baseline by -2.80.1 % with linagliptin/metformin and -2.00.1 % with linagliptin ; a treatment difference of -0.8 % ( 95 % confidence interval -1.1 to -0.5 ; p < 0.0001 ) .
-RESULTS	Similar results were observed in a sensitivity analysis based on intent-to-treat principles : adjusted means.e .
-RESULTS	changes in HbA1c of -2.70.1 % and -1.80.1 % , respectively ; treatment difference of -0.9 % ( 95 % CI -1.3 to -0.6 ; p < 0.0001 ) .
-RESULTS	A treatment response of HbA1c < 7.0 % was achieved by 61 and 40 % of patients in the linagliptin/metformin and linagliptin groups , respectively .
-RESULTS	Few patients experienced drug-related adverse events ( 8.8 and 5.7 % of patients in the linagliptin/metformin and linagliptin groups , respectively ) .
-RESULTS	Hypoglycaemia occurred in 1.9 and 3.2 % of patients in the linagliptin/metformin and linagliptin groups , respectively ( no severe episodes ) .
-RESULTS	Body weight decreased significantly with the combination therapy ( -1.3 kg between-group difference ; p = 0.0033 ) .
-CONCLUSIONS	Linagliptin in initial combination with metformin in patients with newly diagnosed type 2 diabetes and marked hyperglycaemia , an understudied group , elicited significant improvements in glycaemic control with a low incidence of hypoglycaemia , weight gain or other adverse effects .
-CONCLUSIONS	These results support early combination treatment strategies and suggest that newly diagnosed patients with marked hyperglycaemia may be effectively managed with oral , non-insulin therapy .
-
-###24269603
-OBJECTIVE	To assess post-operative pain in patients who underwent arthroscopic anterior cruciate ligament ( ACL ) reconstruction by the all-inside technique .
-METHODS	A prospective randomized comparative parallel trial was performed in 2010-2011 including all patients who underwent an ACL reconstruction in an orthopaedic department in accordance with the CONSORT statement 2010 .
-METHODS	Patients were randomized to the surgical procedure , all-inside or classical , and were blinded to the surgical technique .
-METHODS	Primary evaluation criterion was pain assessed on the Visual Analogical Scale 1 month after surgery .
-METHODS	Secondary parameters were analgesic consumption , tunnel positioning on X-ray according to Aglietti 's criteria and functional evaluation at six months with IKDC score .
-METHODS	None of the patients was lost to follow-up .
-RESULTS	46 consecutive patients were included , 23 in each group , mean age 29.39 years .
-RESULTS	Two patients were excluded due to postoperative complications that required early revision surgery .
-RESULTS	Forty-four patients were analyzed , 22 in each group .
-RESULTS	At one month , the pain level was 3.25.5 for the all-inside group and 8.610 for the classical group , p = 0.057 ( 95 % CI 0.5-10 .4 ) .
-RESULTS	Postoperative analgesic consumption was similar .
-RESULTS	The position of the tibial tunnels was better with the all-inside method , p = 0.002 ( 95 % CI 1.9-6 .6 % ) .
-RESULTS	There was no significant difference in the mean IKDC subjective score at six months , p = 0.92 ( 95 % CI-9 .7 to 9.2 ) .
-CONCLUSIONS	At one month , the pain level seemed lower in the all-inside group than in the classical group , at the limit of statistical significance because the study was underpowered .
-CONCLUSIONS	The all-inside technique is a reliable procedure with very good results for pain , stability and knee function .
-METHODS	I ; Therapeutic study .
-
-###24927436
-OBJECTIVE	To evaluate the effect of oral administration of probiotics on intestinal colonization with drug-resistant bacteria among preterm infants in the neonatal intensive care unit ( NICU ) .
-METHODS	A double-blind , randomized , placebo-controlled trial was carried out in the preterm infants who were transferred to the NICU immediately after birth .
-METHODS	These infants were stratified by whether they were breastfed and then randomized into test group and control group .
-METHODS	The test group was given probiotics from the day when enteral feeding began , while the control group was treated conventionally without probiotics .
-METHODS	The two groups were compared in terms of the colonization with extended-spectrum beta-lactamase-producing bacteria , as assessed by rectal swabs on days 1 , 3 , 7 , and 14 after birth , and the incidence of diseases .
-RESULTS	Rectal colonization with drug-resistant bacteria was found in the test group ( n = 119 ) and control group ( n = 138 ) on days 1 , 3 , 7 , and 14 after birth .
-RESULTS	There were no significant differences in the incidence of late-onset sepsis and necrotizing enterocolitis between the two groups ( P > 0.05 ) .
-RESULTS	Among non-breastfed infants , the test group had significantly decreased rectal colonization with drug-resistant bacteria compared with the control group on day 14 after birth ( 71.1 % vs 88.9 % ; P = 0.04 ) .
-RESULTS	No probiotic-related adverse events were observed in the study .
-CONCLUSIONS	Oral administration of probiotics may reduce rectal colonization with drug-resistant bacteria in preterm infants under certain conditions and shows good safety .
-
-###25286173
-OBJECTIVE	The clinical benefit of adding a macrolide to a - lactam for empirical treatment of moderately severe community-acquired pneumonia remains controversial .
-OBJECTIVE	To test noninferiority of a - lactam alone compared with a - lactam and macrolide combination in moderately severe community-acquired pneumonia .
-METHODS	Open-label , multicenter , noninferiority , randomized trial conducted from January 13 , 2009 , through January 31 , 2013 , in 580 immunocompetent adult patients hospitalized in 6 acute care hospitals in Switzerland for moderately severe community-acquired pneumonia .
-METHODS	Follow-up extended to 90 days .
-METHODS	Outcome assessors were masked to treatment allocation .
-METHODS	Patients were treated with a - lactam and a macrolide ( combination arm ) or with a - lactam alone ( monotherapy arm ) .
-METHODS	Legionella pneumophila infection was systematically searched and treated by addition of a macrolide to the monotherapy arm .
-METHODS	Proportion of patients not reaching clinical stability ( heart rate < 100/min , systolic blood pressure > 90 mm Hg , temperature < 38.0 C , respiratory rate < 24/min , and oxygen saturation > 90 % on room air ) at day 7 .
-RESULTS	After 7 days of treatment , 120 of 291 patients ( 41.2 % ) in the monotherapy arm vs 97 of 289 ( 33.6 % ) in the combination arm had not reached clinical stability ( 7.6 % difference , P = .07 ) .
-RESULTS	The upper limit of the 1-sided 90 % CI was 13.0 % , exceeding the predefined noninferiority boundary of 8 % .
-RESULTS	Patients infected with atypical pathogens ( hazard ratio [ HR ] , 0.33 ; 95 % CI , 0.13-0 .85 ) or with Pneumonia Severity Index ( PSI ) category IV pneumonia ( HR , 0.81 ; 95 % CI , 0.59-1 .10 ) were less likely to reach clinical stability with monotherapy , whereas patients not infected with atypical pathogens ( HR , 0.99 ; 95 % CI , 0.80-1 .22 ) or with PSI category I to III pneumonia ( HR , 1.06 ; 95 % CI , 0.82-1 .36 ) had equivalent outcomes in the 2 arms .
-RESULTS	There were more 30-day readmissions in the monotherapy arm ( 7.9 % vs 3.1 % , P = .01 ) .
-RESULTS	Mortality , intensive care unit admission , complications , length of stay , and recurrence of pneumonia within 90 days did not differ between the 2 arms .
-CONCLUSIONS	We did not find noninferiority of - lactam monotherapy in patients hospitalized for moderately severe community-acquired pneumonia .
-CONCLUSIONS	Patients infected with atypical pathogens or with PSI category IV pneumonia had delayed clinical stability with monotherapy .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00818610 .
-
-###24966672
-BACKGROUND	Olodaterol is a long-acting 2-agonist with a 24-hour bronchodilator profile .
-BACKGROUND	Two replicate , randomized , double-blind , placebo-controlled , parallel-group , Phase III trials were performed as part of a comprehensive clinical program to investigate the long-term safety and efficacy of olodaterol in patients with moderate to very severe chronic obstructive pulmonary disease ( COPD ) receiving usual-care background therapy .
-METHODS	Patients received olodaterol 5 g or 10 g or placebo once daily for 48 weeks .
-METHODS	Coprimary end points were forced expiratory volume in 1 second ( FEV1 ) area under the curve from 0 to 3 hours ( AUC0-3 ) response ( change from baseline ) , and trough FEV1 response at 12 weeks .
-METHODS	Secondary end points included additional lung function assessments , use of rescue medications , FEV1 AUC response from 0 to 12 hours , and Patient Global Rating over 48 weeks .
-RESULTS	Overall , 624 and 642 patients were evaluated in studies 1222.11 and 1222.12 , respectively .
-RESULTS	In both studies , olodaterol 5 g and 10 g significantly improved the FEV1 AUC0-3 response ( P < 0.0001 ) and trough FEV1 ( study 1222.11 , P < 0.0001 ; study 1222.12 , P < 0.05 , post hoc ) at week 12 , with an incidence of adverse events comparable with that of placebo .
-RESULTS	Secondary end points supported the efficacy of olodaterol .
-CONCLUSIONS	These studies demonstrate the long-term efficacy and safety of once-daily olodaterol 5 g and 10 g in patients with moderate to very severe COPD continuing with usual-care maintenance therapy .
-
-###25300706
-OBJECTIVE	WARCEF randomized 2,305 patients in sinus rhythm with ejection fraction ( EF ) 35 % to warfarin ( INR 2.0-3 .5 ) or aspirin 325 mg .
-OBJECTIVE	Warfarin reduced the incident ischemic stroke ( IIS ) hazard rate by 48 % over aspirin in a secondary analysis .
-OBJECTIVE	The IIS rate in heart failure ( HF ) is too low to warrant routine anticoagulation but epidemiologic studies show that prior stroke increases the stroke risk in HF .
-OBJECTIVE	In this study , we explore IIS rates in WARCEF patients with and without baseline stroke to look for risk factors for IIS and determine if a subgroup with an IIS rate high enough to give a clinically relevant stroke risk reduction can be identified .
-METHODS	We compared potential stroke risk factors between patients with baseline stroke and those without using the exact conditional score test for Poisson variables .
-METHODS	We looked for risk factors for IIS , by comparing IIS rates between different risk factors .
-METHODS	For EF we tried cut-off points of 10 , 15 and 20 % .
-METHODS	The cut-off point 15 % was used as it was the highest EF that was associated with a significant increase in IIS rate .
-METHODS	IIS and EF strata were balanced as to warfarin/aspirin assignment by the stratified randomized design .
-METHODS	A multiple Poisson regression examined the simultaneous effects of all risk factors on IIS rate .
-METHODS	IIS rates per hundred patient years ( / 100 PY ) were calculated in patient groups with significant risk factors .
-METHODS	Missing values were assigned the modal value .
-RESULTS	Twenty of 248 ( 8.1 % ) patients with baseline stroke and 64 of 2,048 ( 3.1 % ) without had IIS .
-RESULTS	IIS rate in patients with baseline stroke ( 2.37 / 100 PY ) was greater than patients without ( 0.89 / 100 PY ) ( rate ratio 2.68 , p < 0.001 ) .
-RESULTS	Fourteen of 219 ( 6.4 % ) patients with ejection fraction ( EF ) < 15 % and 70 of 2,079 ( 3.4 % ) with EF 15 % had IIS .
-RESULTS	In the multiple regression analysis stroke at baseline ( p < 0.001 ) and EF < 15 % vs. 15 % ( p = 0.005 ) remained significant predictors of IIS .
-RESULTS	IIS rate was 2.04 / 100 PY in patients with EF < 15 % and 0.95 / 100 PY in patients with EF 15 % ( p = 0.009 ) .
-RESULTS	IIS rate in patients with baseline stroke and reduced EF was 5.88 / 100 PY with EF < 15 % decreasing to 2.62 / 100 PY with EF < 30 % .
-CONCLUSIONS	In a WARCEF exploratory analysis , prior stroke and EF < 15 % were risk factors for IIS .
-CONCLUSIONS	Further research is needed to determine if a clinically relevant stroke risk reduction is obtainable with warfarin in HF patients with prior stroke and reduced EF .
-
-###24219891
-OBJECTIVE	High intake of added sweeteners is considered to have a causal role in the pathogenesis of cardiometabolic disorders .
-OBJECTIVE	Especially , high-fructose intake is regarded as potentially harmful to cardiometabolic health .
-OBJECTIVE	It may cause not only weight gain but also low-grade inflammation , which represents an independent risk factor for developing type 2 diabetes and cardiovascular disease .
-OBJECTIVE	In particular , fructose has been suggested to induce plasminogen activator inhibitor-1 ( PAI-1 ) expression in the liver and to increase circulating inflammatory cytokines .
-OBJECTIVE	We therefore aimed to investigate , whether high-fructose diet has an impact on PAI-1 , monocyte chemoattractant protein-1 ( MCP-1 ) , e-selectin and C-reactive protein ( CRP ) concentrations in healthy humans .
-METHODS	We studied 20 participants ( 12 males and 8 females ) of the TUebingen FRuctose Or Glucose study .
-METHODS	This is an exploratory , parallel , prospective , randomized , single-blinded , outpatient , hypercaloric , intervention study .
-METHODS	The participants had a mean age of 30.9 2.1 years and a mean body mass index of 26.0 0.5 kg/m ( 2 ) and they received 150 g of either fructose or glucose per day for 4 weeks .
-RESULTS	There were neither significant changes of PAI-1 , MCP-1 , e-selectin and CRP after fructose ( n = 10 ) and glucose ( n = 10 ) intervention nor treatment effects ( all P > 0.2 ) .
-RESULTS	Moreover , we did not observe longitudinal associations of the inflammatory parameters with triglycerides , liver fat , visceral fat and body weight in the fructose group .
-CONCLUSIONS	Temporary high-fructose intake does not seem to cause inflammation in apparently healthy people in this secondary analysis of a small feeding trial .
-
-###24502959
-BACKGROUND	Studies have demonstrated that plasmakinetic enucleation of the prostate ( PKEP ) and open prostatectomy ( OP ) have equivalent short-term efficacy for large prostates , but no comparison concerning their long-term results was reported .
-OBJECTIVE	To demonstrate the noninferiority of PKEP to OP concerning maximum urinary flow rate ( Qmax ) at 1 yr postoperatively and to compare the long-term results of both procedures .
-METHODS	From 2004 to 2007 , 160 patients with prostates > 100g were randomized to receive PKEP or OP .
-METHODS	A total of 153 patients ( 95.6 % ) completed the noninferiority study , and 123 patients ( 76.9 % ) finished a 6-yr follow-up assessment .
-METHODS	The PKEP procedures were performed with 27F Karl Storz continuous flow resectoscopy and the Gyrus PlasmaKinetic device .
-METHODS	OP was performed by a suprapubic transvesical approach .
-METHODS	The primary end point was Qmax at 1 yr postoperatively .
-METHODS	Secondary end points included other perioperative parameters and postoperative micturition variables .
-METHODS	The student t test , Mann-Whitney U test , chi-square test , or Fisher exact probability test was used as appropriate .
-CONCLUSIONS	PKEP was noninferior to OP regarding Qmax at 1 yr postoperatively .
-CONCLUSIONS	Compared with OP , PKEP was associated with less perioperative hemoglobin decrease , shorter catheterization time , and shorter postoperative hospital stay ( 1.0 vs 3.2 g/dl , 40 vs 148h , and 3 vs 8 d , respectively ; p < 0.001 for all ) , as well as fewer short-term complications ( 22.5 % vs 42.5 % , p = 0.031 ) .
-CONCLUSIONS	On intention-to-treat analysis , both the PKEP and OP groups had equivalent Qmax ( 25.27.0 ml/s vs 25.77.6 ml/s , respectively ; p = 0.688 ) , International Prostate Symptom Score ( 3.5 [ 2-5 ] vs 3 [ 2-5 ] , respectively p = 0.755 ) , quality of life ( 2 [ 1-3 ] vs 2 [ 1-3 ] , respectively ; p = 0.950 ) , and postvoid residual urine ( 20 [ 9-33 .5 ] vs 16.5 [ 7-31 ] ml , respectively ; p = 0.469 ) at 72 mo postoperatively .
-CONCLUSIONS	No patients required reoperation because of recurrence of BPH .
-CONCLUSIONS	The relatively small sample size is the limitation .
-CONCLUSIONS	PKEP is a durable procedure with short - to long-term micturition improvement equivalent to OP and significantly lower perioperative morbidity .
-RESULTS	We compared PKEP with OP for large prostates and found that PKEP is less invasive , with short - to long-term micturition improvement equivalent to OP .
-BACKGROUND	Plasmakinetic Enucleation of the Prostate and Open Prostatectomy to Treat Large Prostates .
-BACKGROUND	ClinicalTrials.gov identifier NCT01952912 .
-BACKGROUND	http://www.clinicaltrials.gov/ct2/show/NCT01952912?term=NCT016301952912&rank=1 .
-
-###25414152
-OBJECTIVE	To evaluate whether treatment of mild gestational diabetes mellitus ( GDM ) confers sustained offspring health benefits , including a lower frequency of obesity .
-METHODS	Follow-up study of children ( ages 5-10 ) of women enrolled in a multicenter trial of treatment versus no treatment of mild GDM .
-METHODS	Height , weight , blood pressure , waist circumference , fasting glucose , fasting insulin , triglycerides , and HDL cholesterol were measured .
-RESULTS	Five hundred of 905 eligible offspring ( 55 % ) were enrolled .
-RESULTS	Maternal baseline characteristics were similar between the follow-up treated and untreated groups .
-RESULTS	The frequencies of BMI 95th ( 20.8 % and 22.9 % ) and 85th ( 32.6 % and 38.6 % ) percentiles were not significantly different in treated versus untreated offspring ( P = 0.69 and P = 0.26 ) .
-RESULTS	No associations were observed for BMI z score , log waist circumference , log triglycerides , HDL cholesterol , blood pressure , or log HOMA-estimated insulin resistance ( HOMA-IR ) .
-RESULTS	The effect of treatment was different by sex for fasting glucose and log HOMA-IR ( P for interaction = 0.002 and 0.02 , respectively ) but not by age-group ( 5-6 and 7-10 years ) for any outcomes .
-RESULTS	Female offspring of treated women had significantly lower fasting glucose levels .
-CONCLUSIONS	Although treatment for mild GDM has been associated with neonatal benefits , no reduction in childhood obesity or metabolic dysfunction in the offspring of treated women was found .
-CONCLUSIONS	However , only female offspring of women treated for mild GDM had lower fasting glucose .
-
-###25703320
-OBJECTIVE	To evaluate the long-term effects of an illicit drug use prevention program for adolescents that integrates life skills into the theory of planned behavior .
-METHODS	We conducted a cluster-randomized trial in which 24 participating schools were randomized to either an intervention group ( 12 schools , n = 1,176 students ) or a control group ( 12schools , n = 915 students ) .
-METHODS	Participants were grade 7 students .
-METHODS	The intervention comprised a main intervention of 10 sessions and two booster interventions .
-METHODS	Booster 1 ( four sessions ) and booster 2 ( two sessions ) were performed at 6months and 12months , respectively , after completion of the main intervention .
-METHODS	Assessments were made at baseline , after the main intervention , and after each booster session using specific questionnaires for measuring participants ' attitudes , subjective norms , perceived behavioral control , and life skills .
-RESULTS	Retention rates were 71.9 % ( 845/1 ,176 ) in the intervention group and 90.7 % ( 830/915 ) in the control group after the 12-month follow-up .
-RESULTS	A significantly lower proportion of intervention group participants reported illicit drug use after the first and second booster sessions compared with control group participants ( .1 % vs. 1.7 % and .2 % vs. 1.7 % , respectively ; both p < .05 ) .
-RESULTS	Attitudes , subjective norms , perceived behavioral control , life skills , and behavioral intention scores of theintervention group were significantly higher than those of control group after the first and second booster sessions ( all p < .001 ) , suggesting that intervention group students tended to avoid drug use .
-CONCLUSIONS	A drug use prevention program integrating life skills into the theory of planned behavior may be effective for reducing illicit drug use and improving planned behavior-related constructs in adolescents .
-
-###26054142
-OBJECTIVE	To compare the difference of the clinical efficacy in treatment of nervous tinnitus of kidney deficiency between the combined therapy of Zhuang medicine at Qineihuan point combined with the conventional acupuncture and simple conventional acupancture .
-METHODS	Sixty patients were randomized into an observation group and a control group , 30 cases in each one .
-METHODS	In the control group , the conventional acupuncture was applied to Taixi ( KI 3 ) , Zhaohai ( KI 6 ) , Tinggong ( SI 19 ) and Waiguan ( TE 5 ) , etc. and the needles were retained for 30 min .
-METHODS	In the observation group , on the basic treatment as the control group , Zhuang medicine acupuncture at Qineihuan point was added .
-METHODS	The treatment was given once every day , 10 treatments made one session and there were 2 days of interval between the sessions .
-METHODS	In 3 sessions of treatment , the changes of tinnitus were observed and the clinical efficacy was evaluated .
-RESULTS	After treatment , tinnitus score and tinnitus grade were all improved as compared with those before treatment in the two groups ( all P < 0.05 ) and the results in the observation group were better than those in the control group ( all P < 0.05 ) .
-RESULTS	The curative and remarkably effective rate was 63.3 % ( 19/30 ) and the total effective rate was 93.3 % ( 28/30 ) in the observation group , better than 30.0 % ( 9/30 ) and 73.3 % ( 22/30 ) in the control group ( both P < 0.05 ) .
-CONCLUSIONS	The combined therapy of Zhuang medicine at Qineihuan point and conventional acupuncture achieves the better efficacy on nervous tinnitus of kidney deficiency as compared with the simple conventional acupuncture .
-
-###25319385
-OBJECTIVE	Presepsin is a soluble fragment of the cluster-of-differentiation marker protein 14 ( CD14 ) involved in pathogen recognition by innate immunity .
-OBJECTIVE	We evaluated the relation between its circulating concentration , host response , appropriateness of antibiotic therapy , and mortality in patients with severe sepsis .
-METHODS	Plasma presepsin was measured 1 , 2 , and 7 days after enrollment of 997 patients with severe sepsis or septic shock in the multicenter Albumin Italian Outcome Sepsis ( ALBIOS ) trial .
-METHODS	They were randomized to albumin or crystalloids .
-METHODS	We tested with univariate and adjusted models the association of single measurements of presepsin or changes over time with clinical events , organ dysfunctions , appropriateness of antibiotic therapy , and ICU or 90-day mortality .
-RESULTS	Presepsin concentration at baseline ( 946 [ 492-1 ,887 ] ng/L ) increased with the SOFA score , the number of prevalent organ dysfunctions or failures , and the incidence of new failures of the respiratory , coagulation , liver , and kidney systems .
-RESULTS	The concentration decreased in ICU over 7 days in patients with negative blood cultures , and in those with positive blood cultures and appropriate antibiotic therapy ; it increased with inappropriate antibiotic therapy ( p = 0.0009 ) .
-RESULTS	Baseline presepsin was independently associated with , and correctly reclassified , the risk of ICU and 90-day mortality .
-RESULTS	Increasing concentrations of presepsin from day 1 to day 2 predicted higher ICU and 90-day mortality ( adjusted p < 0.0001 and 0.01 , respectively ) .
-RESULTS	Albumin had no effect on presepsin concentration .
-CONCLUSIONS	Presepsin is an early predictor of host response and mortality in septic patients .
-CONCLUSIONS	Changes in concentrations over time seem to reflect the appropriateness of antibiotic therapy .
-
-###24507830
-BACKGROUND	The methacholine challenge test quantifies airway hyper-responsiveness , which is measured by the provocative concentration of methacholine causing a 20 % decrease in forced expiration volume in 1 second ( PC20 ) .
-BACKGROUND	The dose-response effect of inhaled corticosteroids ( ICS ) on PC20 has been inconsistent and within-patient variability of PC20 is not well established .
-OBJECTIVE	To determine the effect of high - vs low-dose ICS on PC20 and within-patient variability in those with repeated measurements of PC20 .
-METHODS	A randomized , double-masked , crossover trial was conducted in patients with asthma on controller medications with PC20 of 8 mg/mL or lower ( n = 64 ) to evaluate the effect of high-dose ( 1,000 g/d ) vs low-dose ( 250 g/d ) fluticasone for 4 weeks on PC20 .
-METHODS	In addition , the variability of PC20 was assessed in participants who underwent 2 or 3 PC20 measurements on the same dose of ICS ( n = 27 ) over a 4-week interval .
-RESULTS	Because there was a significant period effect , dose comparison of the change in PC20 was assessed in the first treatment period .
-RESULTS	There was no significant difference in the change in PC20 for high - vs low-dose ICS ( 39 % vs 30 % increase , respectively ; P = .87 ) .
-RESULTS	The within - and between-participant variances for log PC20 were 0.84 and 0.96 , respectively , with an intra-class correlation of 0.53 , and 37 % of participants had more than 2 doubling dose changes in PC20 in those with repeated measurements .
-CONCLUSIONS	The effect of ICS on PC20 is not dose dependent at fluticasone levels of 250 and 1,000 g/d .
-CONCLUSIONS	Interpersonal variability for PC20 is large .
-CONCLUSIONS	A lack of precise measurements should be taken into account when interpreting any change in PC20 .
-
-###24976433
-OBJECTIVE	Selenium supplementation for women infected with HIV may increase genital shedding of HIV-1 , however , to our knowledge , no studies have examined the effect on viral shedding in breast milk .
-OBJECTIVE	The aim of this study was to determine the effect of selenium supplementation on HIV-1 RNA detection in breast milk of HIV-infected women .
-METHODS	HIV-infected pregnant women enrolled at 12 to 27 wk gestation in a randomized , double-blind , placebo-controlled trial of daily selenium ( 200 g as selenomethionine ) had cell-free HIV-1 RNA quantified in breast milk at 4 to 9 wk postpartum .
-METHODS	All participants received high-dose multivitamins containing vitamin B complex , C , and E as standard of care .
-RESULTS	The proportion of women with detectable ( > 50 copies/mL ) HIV-1 RNA in breast milk appeared to be increased in the selenium group ( 36.4 % ) compared with those in the placebo group ( 27.5 % ) among the total cohort ( N = 420 ) , but results were borderline statistically significant ( relative risk [ RR ] , 1.32 ; 95 % confidence interval [ CI ] , 1.00-1 .76 ; P = 0.05 ) .
-RESULTS	In secondary analyses , the proportion of women with detectable HIV-1 RNA in breast milk was significantly greater in the selenium group ( 37.8 % ) compared with placebo group ( 27.5 % ) among women who did not receive highly active antiretroviral therapy ( HAART ; RR , 1.37 ; 95 % CI , 1.03-1 .82 ; P = 0.03 ) .
-RESULTS	This relationship was primarily due to a significant effect of selenium among primiparous women ( RR , 2.24 ; 95 % CI , 1.30-3 .86 ; P < 0.01 ) , but not multiparous women ( RR , 1.14 ; 95 % CI , 0.81-1 .59 ; P = 0.54 ) ( P-value for interaction = 0.02 ) .
-RESULTS	Too few women received HAART in this study ( n = 12 ) to establish the effect of selenium supplementation .
-CONCLUSIONS	Selenium supplementation appears to increase HIV-1 RNA detection in breast milk among primiparous women not receiving HAART .
-CONCLUSIONS	Safety studies among pregnant women on HAART need to be conducted before administering selenium-containing supplements .
-
-###25249415
-BACKGROUND	Published studies have reported conflicting results regarding the effects of cinnamon on glucose , lipids and insulin .
-BACKGROUND	To gain further insight into the metabolic effects of Cinnamomum cassia we performed randomized , double-blinded placebo-controlled study using euglycaemic-hyperinsulinaemic clamp .
-METHODS	Twenty-one subjects with impaired glucose tolerance ( IGT ) were included in the study ( 10 or 11 subjects in each group ) .
-METHODS	The study groups were matched for age , gender and body mass index ( BMI ) .
-METHODS	Waist-to-hip ratio , BMI , blood pressure , fasting blood glucose , insulin , triglycerides , total cholesterol , low-density lipoprotein , high-density lipoprotein , HbA1c , ASAT , ALAT , bilirubin , ALP , GT and PK were measured before and after the intake of capsules equivalent to 6 g cinnamon twice a day for 12 weeks .
-METHODS	The changes in insulin resistance were measured by euglycaemic-hyperinsulinaemic clamp .
-METHODS	The Wilcoxon signed rank sum test , the Mann-Whitney U test and Pearson 's chi-squared test were used to analyse the data .
-METHODS	Values of p < 0.05 were considered to indicate statistically significant differences .
-RESULTS	At enrolment , the groups were similar in terms of age , gender and BMI .
-RESULTS	Of the 21 randomized patients with IGT , 17 completed the study ( 8 controls vs. 9 treated ) .
-RESULTS	The ingestion of 6 g cinnamon twice a day for 12 weeks had no significant effect on insulin sensitivity , HbA1c , fasting glucose or BMI .
-RESULTS	No significant changes were seen in lipids or liver enzymes .
-CONCLUSIONS	This study showed that ingestion of 6 g C. cassia twice a day for 12 weeks did not change the insulin sensitivity or liver enzymes in subjects with IGT .
-
-###24443982
-BACKGROUND	Up to 30 % of patients suffer from long-term functional restrictions following conservative treatment of distal radius fractures .
-BACKGROUND	Whether duration of cast immobilisation influences functional outcome remains unclear .
-METHODS	The aim of the study is to evaluate whether the duration of immobilization of non or minimally displaced distal radial fractures can be safely reduced .
-METHODS	We will compare three weeks of plaster cast immobilization with five weeks of plaster cast immobilization in adult patient with non or minimally displaced distal radial fractures .
-METHODS	a prospective randomized clinical trial .
-METHODS	adult ( > 18 years ) ( independent in activities of daily living ) patients with a non/minimal displaced distal radius fracture ( dorsal angulation < 15 , volar tilt < 20 , radial inclination > 15 , ulnar positive variance < 5 mm and an articular step off < 2 mm ) .
-METHODS	three weeks of plaster cast immobilization versus five weeks of plaster cast immobilization.Main study parameters : primary outcome parameters : Patient related wrist evaluation ( PRWE ) Quick Disability of Arm , Shoulder and Hand ( QUICKDASH ) score after a one year follow-up , and secondary parameters : range of motion , pain level ( VAS ) and complications .
-CONCLUSIONS	The expectation of this study is that shorter duration of plaster cast immobilisation is beneficial for the patient with a distal radius fracture .
-CONCLUSIONS	This risk of specific complications is low and generally similar in both treatment options .
-CONCLUSIONS	Moreover , the burden of the study is not much higher compared to standard treatment .
-CONCLUSIONS	Follow-up is standardized according to current trauma guidelines .
-CONCLUSIONS	Literature indicates that both treatment options from the study are accepted for displaced distal radius fractures .
-CONCLUSIONS	No clear advantage for one treatment options is found at present in the literature , although there is no level I evidence present .
-CONCLUSIONS	This trial will provide level-1 evidence for the comparison of consolidation and functional outcome between two treatment options for non-displaced distal radial fractures .
-CONCLUSIONS	The gathered data may support the development of a clinical guideline for conservative treatment of distal radial fractures .
-BACKGROUND	Netherlands National Trial Register NTR3552 .
-
-###24265159
-BACKGROUND	The event-free survival of childhood acute lymphoblastic leukemia ( ALL ) has been reported to be superior when oral methotrexate ( MTX ) and 6-mercaptopurine ( 6MP ) maintenance therapy ( MT ) is administered in the evening compared to the morning .
-METHODS	In the ALL92 MT study we prospectively registered the intake of MTX/6MP .
-METHODS	The registration was done when blood samples for erythrocyte MTX/6MP metabolite measurements were collected , and referred to the time of intake in the period since last registration .
-METHODS	Nine thousand one hundred ninety-five registrations in total .
-METHODS	The administration of MTX/6MP was scored as morning , midday , or evening .
-RESULTS	Of 532 patients , 296 took their medication consistently in the evening , 129 in the evening 50.0-99 .9 % of the time , and 101 in the evening < 50 % of the time , six did not have any registrations .
-RESULTS	The circadian schedule did not differ significantly by age , sex , MTX/6MP doses , and average absolute neutrophil counts .
-RESULTS	The circadian schedule groups did differ on risk groups ( P = 0.003 ) with fewer HR patients in the 50-99 .9 % group , and there was a negative correlation between percentage of time on evening schedule and average WBC ( Spearman 's rho -0.15 ; P = 0.0004 ) .
-RESULTS	Average WBC was not associated with relapse on ALL92 .
-RESULTS	In a Cox multivariate model the circadian schedule of MTX/6MP was not of prognostic significance for the risk of relapse , and the 10-year cumulative relapse risk was below 20 % in all groups .
-CONCLUSIONS	An evening schedule may still be recommended based on the previous publications , but in this study morning administration of MTX and 6MP does not seem to impact EFS .
-
-###25710762
-OBJECTIVE	To quantify plasma concentrations and determine adverse ocular , renal , or hepatic effects associated with repeated topical ophthalmic application of 0.1 % diclofenac to healthy cats .
-METHODS	8 healthy sexually intact male cats .
-METHODS	A randomized , placebo-controlled crossover study was conducted .
-METHODS	A topical formulation of 0.1 % diclofenac was administered 4 times/d for 7 days to 4 cats , and artificial tear ( control ) solution was administered to the other 4 cats .
-METHODS	After a 12-day washout period , cats received the other treatment .
-METHODS	Ophthalmic examinations were performed daily .
-METHODS	Plasma samples were obtained on days 1 and 7 for pharmacokinetic analysis .
-METHODS	A CBC , serum biochemical analysis , urinalysis , determination of urine protein-to-creatinine ratio , and determination of glomerular filtration rate were performed before the start of the study and after each 7-day treatment period .
-RESULTS	Mild conjunctival hyperemia was the only adverse ocular effect detected .
-RESULTS	Maximal drug concentration and area under the curve were significantly higher on day 7 than on day 1 .
-RESULTS	Diclofenac-treated cats had a significantly lower glomerular filtration rate than did control-treated cats after the second but not after the first treatment period , presumably associated with iatrogenic hypovolemia .
-CONCLUSIONS	Topical ophthalmic administration of 0.1 % diclofenac was well tolerated in healthy cats , with only mild signs of ocular irritation .
-CONCLUSIONS	Detectable systemic concentrations of diclofenac were achieved with accumulation over 7 days .
-CONCLUSIONS	Systemic absorption of diclofenac may be associated with reduced glomerular filtration rate , particularly in volume-contracted animals .
-CONCLUSIONS	Topical ophthalmic 0.1 % diclofenac should be used with caution in volume-contracted or systemically ill cats .
-
-###25636048
-BACKGROUND	Mild primary hyperparathyroidism ( PHPT ) is a common disease especially in middle-aged and elderly women .
-BACKGROUND	The diagnosis is frequently made incidentally and treatment strategies are widely discussed .
-OBJECTIVE	To study the effect of parathyroidectomy ( PTX ) compared with observation ( OBS ) on biochemistry , safety , bone mineral density ( BMD ) , and new fractures .
-METHODS	Prospective , randomized controlled study ( SIPH study ) , with a 5-year follow-up .
-METHODS	The study was conducted at multicenter , tertiary referral centers .
-METHODS	Of 191 randomized patients with mild PHPT , biochemical data were available for 145 patients after 5 years , with a mean age at inclusion of 62.8 years ( OBS group , 9 males ) and 62.1 years ( PTX group , 10 males ) .
-METHODS	Parathyroidectomy vs observation .
-METHODS	Biochemistry , BMD , and new radiographic vertebral fractures .
-RESULTS	Serum-calcium and PTH-levels normalized after surgery and did not deteriorate by observation .
-RESULTS	BMD Z-scores were normal at inclusion in the lumbar spine ( LS ) and femoral neck ( FN ) .
-RESULTS	For LS , BMD Z-scores were stable for 5 years with observation , but decreased in FN ( P < .02 ) .
-RESULTS	After surgery , BMD Z-scores increased significantly in both compartments ( P < .02 for both ) , with a highly significant treatment effect of surgery compared to observation ( P < .001 ) .
-RESULTS	During follow-up , five new clinically unrecognized vertebral fractures were found in 5 females , all in the OBS group ( P = .058 ) .
-CONCLUSIONS	Even though new vertebral fractures occurred only in the observation group , the frequency was not significantly different from the surgery group .
-CONCLUSIONS	Longer follow-up is needed before firm conclusions can be drawn about the long-term safety of observation , as opposed to surgery .
-
-###24965060
-BACKGROUND	The purpose of this multicenter randomly controlled clinical trial was to compare two acellular dermal matrix ( ADM ) materials produced by different processing techniques , freeze-dried ( FDADM ) and solvent-dehydrated ( SDADM ) ADM , in their ability to correct Miller Class I and II recession defects .
-METHODS	Eighty individuals from four study centers , each with a single maxillary anterior Miller Class I or II recession defect were enrolled .
-METHODS	Participants were randomly assigned and treated with coronally advanced flap ( CAF ) + FDADM ( n = 42 ) or CAF + SDADM ( n = 38 ) .
-METHODS	Gingival thickness , recession depth , recession width , probing depth ( PD ) , clinical attachment level , gingival index , plaque index , patient discomfort , and wound healing index were recorded before surgery ( day 0 ) , immediately after surgery ( day 1 ) , and 2 , 4 , 12 , 24 , and 52 weeks postoperatively .
-METHODS	The Student t test , paired t test , and Kruskal-Wallis one-way ANOVA were used to analyze the data .
-RESULTS	When evaluating the clinical parameters after 1 year , both groups showed significant ( P < 0.05 ) improvement for most of the parameters evaluated when compared to baseline ( day 0 ) .
-RESULTS	For example , percentage of root coverage was 77.21 % 29.10 % for CAF + FDADM and 71.01 % 32.87 % for CAF + SDADM .
-RESULTS	Conversely , no significant differences were observed between the two materials for any clinical parameter tested or for patient satisfaction except PD on the mesial side of the defects ( P = 0.03 ) .
-CONCLUSIONS	Both FDADM and SDADM can be used successfully to correct Miller Class I or II recession defects .
-CONCLUSIONS	There were no statistically significant differences between groups for any of the clinical parameters tested .
-
-###24889213
-BACKGROUND	Total Hip Arthroplasty ( THA ) is being used more commonly in younger higher demand patients .
-BACKGROUND	The purpose of this randomized pilot study was to explore a ) feasibility of comprehensive postoperative rehabilitation compared to usual care following primary THA in subjects < 65 years , b ) appropriate outcome measures including performance-based measures and c ) timing of assessments .
-METHODS	21 subjects who underwent primary THA were randomized to receive a three-month out-patient rehabilitation program ( Intervention ) or usual postoperative care ( Control ) .
-METHODS	Subjects were assessed preoperatively , six-weeks postoperatively ( Pre-intervention ) and four and 12 months postoperatively ( Post-intervention ) .
-METHODS	Self-report measures were the Western Ontario McMaster Osteoarthritis Index ( WOMAC ) and Rand 36-Item Health Survey ( RAND-36 ) .
-METHODS	Performance-based measures included lower extremity strength , walking speed and endurance , and gait laboratory assessment .
-RESULTS	Ten Control and 11 Intervention subjects with an average age of 53.4 ( SD9 .3 ) years were randomized .
-RESULTS	All Intervention subjects completed the program without adverse effects .
-RESULTS	Although no statistically significantly results were reported , four months postoperatively , Intervention subjects had clinically important differences ( CID ) in strength compared with Control subjects .
-RESULTS	Walking endurance , WOMAC and RAND scores improved significantly with no CID noted between groups .
-RESULTS	Ten ( 48 % ) subjects reported a ceiling effect on the WOMAC ( 9 ( 43 % ) subjects on Pain ; 1 ( 5 % ) subject on Function ) .
-RESULTS	No group CID were noted in gait measures .
-CONCLUSIONS	Our recommendations would be that performance-based strength measures should be considered for the primary outcome in this younger cohort .
-CONCLUSIONS	Because of the ceiling effects with WOMAC Pain , a different pain measure is indicated .
-CONCLUSIONS	Other more challenging functional performance-based tests should be considered such as a more prolonged endurance test .
-CONCLUSIONS	There is merit in one-year follow-up as strength improved after four months in both groups .
-
-###24429202
-BACKGROUND	Long-term complications of cystic fibrosis include osteoporosis and fragility fractures , but few data are available about effective treatment strategies , especially in young patients .
-BACKGROUND	We investigated treatment of low bone mineral density in children , adolescents , and young adults with cystic fibrosis .
-METHODS	We did a multicentre trial in two phases .
-METHODS	We enrolled patients aged 5-30 years with cystic fibrosis and low bone mineral density , from ten cystic fibrosis regional centres in Italy .
-METHODS	The first phase was an open-label , 12-month observational study of the effect of adequate calcium intake plus calcifediol .
-METHODS	The second phase was a 12-month , double-blind , randomised , placebo-controlled , parallel group study of the efficacy and safety of oral alendronate in patients whose bone mineral apparent density had not increased by 5 % or more by the end of the observational phase .
-METHODS	Patients were randomly assigned to either alendronate or placebo .
-METHODS	Both patients and investigators were masked to treatment assignment .
-METHODS	We used dual x-ray absorptiometry at baseline and every 6 months thereafter , corrected for body size , to assess lumbar spine bone mineral apparent density .
-METHODS	We assessed bone turnover markers and other laboratory parameters every 3-6 months .
-METHODS	The primary endpoint was mean increase of lumbar spine bone mineral apparent density , assessed in the intention-to-treat population .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT01812551 .
-RESULTS	We screened 540 patients and enrolled 171 ( mean age 138 years , SD 59 , range 5-30 ) .
-RESULTS	In the observational phase , treatment with calcium and calcifediol increased bone mineral apparent density by 5 % or more in 43 patients ( 25 % ) .
-RESULTS	128 patients entered the randomised phase .
-RESULTS	Bone mineral apparent density increased by 163 % in the alendronate group ( n = 65 ) versus 31 % in the placebo group ( n = 63 ; p = 00010 ) .
-RESULTS	19 of 57 young people ( 333 % ) receiving alendronate attained a normal-for-age bone mineral apparent density Z score .
-RESULTS	In the observational phase , five patients had moderate episodes of hypercalciuria , which resolved after short interruption of calcifediol treatment .
-RESULTS	During the randomised phase , one patient taking alendronate had mild fever versus none in the placebo group ; treatment groups did not differ significantly for other adverse events .
-CONCLUSIONS	Correct calcium intake plus calcifediol can improve bone mineral density in some young patients with cystic fibrosis .
-CONCLUSIONS	In those who do not respond to calcium and calcifediol alone , alendronate can safely and effectively increase bone mineral density .
-BACKGROUND	Telethon Foundation ( Italy ) .
-
-###25005045
-BACKGROUND	The optimal crystalloid solution to use perioperatively in patients undergoing open radical cystectomy remains unclear .
-BACKGROUND	Many of the fluids used for intravenous hydration contain supraphysiologic concentrations of chloride , which can induce hyperchloremia and metabolic acidosis , resulting in renal vasoconstriction and decreased renal function .
-BACKGROUND	In addition , patients receiving less fluid and less sodium show faster recovery of gastrointestinal ( GI ) function after colonic surgery .
-METHODS	This is an investigator-initiated , single-center , randomized , controlled , parallel group trial with assessor-blinded outcome assessment , in the Department of Urology , University Hospital Bern , Switzerland .
-METHODS	The study will involve 44 patients with bladder cancer scheduled for radical cystectomy and urinary diversion .
-METHODS	The primary outcome is the duration between the end of surgery and the return of the GI function ( first defecation ) .
-METHODS	Secondary outcomes are fluid balance ( body weight difference postoperatively versus preoperatively ) and the incidence of kidney function disorders according to the Risk-Injury-Failure-Loss-End Stage Renal Disease ( RIFLE classification ) .
-METHODS	An equal number of patients are allocated to receive Ringerfundin solution or a glucose/potassium-based balanced crystalloid solution as baseline infusion during the entire time that intravenous administration of fluid is necessary during the perioperative period .
-METHODS	The randomized crystalloid solution is infused at a rate of 1 ml/kg/h until the bladder has been removed , followed by 3 ml/kg/h until the end of surgery .
-METHODS	Postoperative hydration is identical in both groups and consists of 1,500 ml of the randomized crystalloid solution per 24 hours .
-METHODS	Postoperative patient care is identical in both groups ; patients are allowed to drink clear fluids immediately after surgery , and liquid diet is started on postoperative day 1 , as well as active mobilization and the use of chewing gum .
-METHODS	Body weight is measured daily in the morning .
-METHODS	Time of first flatus and first defecation are recorded .
-CONCLUSIONS	This trial assesses the benefits and harms of two different balanced crystalloid solutions for perioperative fluid management in patients undergoing open radical cystectomy with urinary diversion , with regard to return of GI function and effects on postoperative renal function .
-BACKGROUND	Current Controlled Trials ISRCTN32976792 ( registered on November 21 2013 ) .
-
-###25200821
-OBJECTIVE	Tubal factor accounts for 25-30 % of cases of female infertility .
-OBJECTIVE	Laparoscopy `` Gold Standard '' for tubal evaluation .
-OBJECTIVE	However , it is known that during the initial infection of the fallopian tube mucosal damage occurs , a condition which plays a decisive role in reproduction .
-METHODS	In this prospective randomized study , 468 infertile women with evidence of fallopian tube disease were included .
-METHODS	In this , for 256 patients ( group 1 ) after laparoscopic salpingolysis , salpingostomy we performed an additional step operation transcervical falloposcopy tubal dilatation ( TFTD ) .
-METHODS	212 patients ( group 2 ) produced only laparoscopic salpingolysis , salpingostomy .
-RESULTS	As a result , TFTD patency of the fallopian tubes for coaxial catheter was restored in 50 ( 78 % ) of 64 tubes with bilateral total occlusion , in 238 ( 93 % ) of 254 with partial occlusion of the bilateral , in 14 ( 58 % ) of 24 total unilateral occlusion and 26 ( 92 % ) of 28 with partial unilateral occlusion .
-RESULTS	Total number of pregnancies for one year in the first group of patients was 152 ( 59.3 % ) , in the second 57 ( 27.1 % ) , of which in the first group 147 - intrauterine pregnancies ( 57.4 % ) and in the second - 46 ( 21.7 % ) .
-CONCLUSIONS	Falloposcopy surgeon provides good opportunities for the diagnosis and treatment of intralumen lesions .
-CONCLUSIONS	Significant increase in the frequency of uterine pregnancy in the case of an additional step - TFTD during salpingolysis , salpingostomy in patients with tubal factor infertility .
-
-###24582119
-OBJECTIVE	To determine clinical and demographic characteristics associated with antimuscarinic treatment response using a regression model .
-METHODS	Adults with overactive bladder ( OAB ) symptoms for > 3 months and 1 urgency urinary incontinence ( UUI ) episode and 8 micturitions per 24 hours at baseline were randomized to fesoterodine ( 8 mg ) , tolterodine extended-release ( 4 mg ) , or placebo in two 12-week , double-blind , head-to-head studies .
-METHODS	Fesoterodine-treated patients received 4 mg/d during the first week and 8 mg/d thereafter .
-METHODS	Patients completed 3-day bladder diaries and the Overactive Bladder Questionnaire at baseline and week 12 .
-METHODS	Pooled data for changes from baseline to week 12 in winsorized UUI episodes , micturitions , and urgency episodes per 24 hours and Overactive Bladder Questionnaire Symptom Bother and health-related quality of life scores were analyzed posthoc using a regression model that selects outcome predictors from baseline values and patient characteristics while retaining baseline values and treatment , with stepwise inclusion of significant covariates and assessment of treatment interactions .
-METHODS	Logistic regression was used for analysis of diary-dry rates .
-RESULTS	Younger age , lack of previous antimuscarinic treatment , shorter duration of OAB diagnosis , and female gender were common predictors of larger changes in outcomes from baseline to week 12 .
-RESULTS	Baseline measures often interacted with treatment , such that poorer baseline outcomes were predictive of larger treatment differences .
-RESULTS	Longer duration since OAB diagnosis predicted greater treatment differences for UUI episodes and in diary-dry rate , and increased age predicted greater treatment differences for micturitions .
-CONCLUSIONS	Symptom severity and duration , age , gender , and previous antimuscarinic pharmacotherapy impact the response to antimuscarinic treatment .
-
-###24441734
-OBJECTIVE	To compare long-term functional and radiological outcome following microfracture technique ( MF ) versus osteochondral autologous transplantation ( OAT ) mosaicplasty for treating focal chondral lesions of the knee .
-METHODS	Twenty-five patients ( mean age 32.3 years , SD 7.7 ) with a full-thickness ( International Cartilage Repair Society grade 3 or 4 ) chondral lesion of the articulating surface of the femur were randomized to either MF ( n = 11 ) or OAT mosaicplasty ( n = 14 ) .
-METHODS	At a median follow-up of 9.8 years ( range 4.9-11 .4 ) , the patients were evaluated using Lysholm score ( n = 25 ) , Knee Injury and Osteoarthritis Outcome Score ( KOOS , n = 25 ) , isokinetic quadriceps measurement and hamstring strength measurement ( n = 22 ) and standing radiographs ( n = 23 ) .
-RESULTS	There were no significant differences in Lysholm score , KOOS , isokinetic muscle strength or radiographic osteoarthritis between MF-treated patients and OAT mosaicplasty-treated patients at follow-up .
-RESULTS	Mean Lysholm score at follow-up was 69.7 [ 95 % confidence interval ( CI ) , 55.1-84 .4 ] for the MF group and 62.6 ( 95 % CI , 52.6-72 .6 ) for the OAT mosaicplasty group .
-CONCLUSIONS	At long-term follow-up , there were no significant differences between patients treated with MF and patients treated with OAT mosaicplasty in patient-reported outcomes , muscle strength or radiological outcome .
-METHODS	Therapeutic study , Level II .
-
-###25463664
-BACKGROUND	Studies suggest that smokers present more or greater numbers of potential periodontal pathogens than non-smokers .
-BACKGROUND	The aim of this study was to investigate the microbiologic effects of adjunctive aPDT on nonsurgical periodontal treatment in smokers with chronic periodontitis ( CP ) .
-METHODS	Twenty smokers with CP had two contralateral teeth randomly assigned in a split-mouth design to receive SRP ( CG ) or SRP + a single episode of aPDT ( TG ) , with a diode laser and a phenothiazine photosensitizer .
-METHODS	Levels of 40 subgingival species were measured using checkerboard DNA-DNA hybridization at baseline and 1 , 4 and 12 weeks after periodontal treatment .
-RESULTS	All 40 bacterial species evaluated were detected in different levels at baseline , with no statistic significant differences between groups .
-RESULTS	After periodontal treatment , the levels of some bacterial species decreased , while some other species presented an increase .
-RESULTS	Despite this variation , the statistical analysis was not able to identify significant differences neither at intragroup nor at intergroup comparisons .
-CONCLUSIONS	Periodontal treatment with SRP or SRP + aPDT was not able to reduce levels of 40 subgingival species in smokers with CP .
-CONCLUSIONS	These outcomes indicate that smoking impairs periodontal healing after nonsurgical treatment even associated with aPDT .
-
-###24429164
-OBJECTIVE	To evaluate whether patients with rheumatoid arthritis who did not respond sufficiently to tocilizumab ( TCZ ) plus disease-modifying antirheumatic drug ( DMARD ) treatment by Week 8 responded at later timepoints when continuing to take their original dose of TCZ .
-METHODS	In this posthoc analysis of data from phase III randomized controlled trials of inadequate responders ( IR ) to DMARD or tumor necrosis factor - inhibitors ( anti-TNF ) , percentages of patients meeting early response criteria were calculated by randomized treatment arm ( TCZ 4 mg/kg , 8 mg/kg , or placebo in combination with DMARD ) .
-METHODS	Percentages of patients achieving certain disease activity thresholds at later timepoints were calculated for patients who had/had not achieved response by Week 8 .
-RESULTS	In DMARD-IR early nonresponders , 29.0 % , 17.2 % , and 3.7 % of TCZ 8 mg/kg-randomized , TCZ 4 mg/kg-randomized , and placebo-randomized patients , respectively , achieved 28-joint Disease Activity Score ( DAS28 ) 3.2 by Week 24 .
-RESULTS	Among anti-TNF-IR patients without early response , 26.5 % , 8.5 % , and 1.9 % of TCZ 8 mg/kg-randomized , TCZ 4 mg/kg-randomized , and placebo-randomized patients , respectively , achieved DAS28 3.2 at Week 24 .
-CONCLUSIONS	A substantial number of DMARD-IR patients taking TCZ 4 or 8 mg/kg and anti-TNF-IR patients taking TCZ 8 mg/kg who failed to respond by 8 weeks benefited from continued TCZ treatment in combination with DMARD .
-CONCLUSIONS	In contrast , the anti-TNF-IR patients without early responses who continued to take TCZ 4 mg/kg were unlikely to experience a cumulative benefit .
-CONCLUSIONS	ClinicalTrials.gov registration numbers : NCT00106548 , NCT00106574 , NCT00106535 , NCT00106522 .
-
-###25277144
-OBJECTIVE	The objective of this study was to assess the safety , tolerability , pharmacokinetics , and pharmacodynamics of selexipag , an orally available selective prostacyclin receptor agonist , in development for pulmonary arterial hypertension in healthy subjects .
-METHODS	This was a double-blind , placebo-controlled , randomised , multiple-ascending-dose , up-titration study .
-METHODS	Male subjects received increasing oral doses of selexipag ( 400-1 ,800 g ; n = 12 ) or placebo ( n = 4 ) twice daily for 3 days each , using incremental steps of 200 g between each dose level .
-METHODS	Standard safety and tolerability data were collected .
-METHODS	Blood samples were taken to assess the pharmacokinetics of selexipag and its active metabolite ACT-333679 and possible effects on platelet aggregation .
-RESULTS	Dose levels of selexipag up to 1,600 g were well tolerated and this dose was identified as the maximum tolerated dose .
-RESULTS	Plasma exposure to ACT-333679 was approximately 4 times higher than that to selexipag .
-RESULTS	Steady-state conditions for both compounds were reached on day 3 of each dose level , and no accumulation of selexipag or ACT-333679 was observed .
-RESULTS	Based on the area under the curve and the maximum plasma concentration , the pharmacokinetics of selexipag and ACT-333679 were dose proportional .
-RESULTS	At the highest dose level , the geometric mean terminal half-life of selexipag and ACT-333679 was 1.4 and 8.7 h , respectively .
-RESULTS	The observed effects on platelet aggregation were variable without obvious drug - or dose-dependent pattern .
-CONCLUSIONS	Oral administration of increasing doses of selexipag was well tolerated .
-CONCLUSIONS	The present results support the conduct of future clinical trials .
-
-###25512670
-BACKGROUND	The objective of this study was to compare the costs and outcomes of two sexually transmitted infection ( STI ) screening interventions targeted at men in football club settings in England , including screening promoted by team captains .
-METHODS	A comparison of costs and outcomes was undertaken alongside a pilot cluster randomised control trial involving three trial arms : ( 1 ) captain-led and poster STI screening promotion ; ( 2 ) sexual health advisor-led and poster STI screening promotion and ( 3 ) poster-only STI screening promotion ( control/comparator ) .
-METHODS	For all study arms , resource use and cost data were collected prospectively .
-RESULTS	There was considerable variation in uptake rates between clubs , but results were broadly comparable across study arms with 50 % of men accepting the screening offer in the captain-led arm , 67 % in the sexual health advisor-led arm and 61 % in the poster-only control arm .
-RESULTS	The overall costs associated with the intervention arms were similar .
-RESULTS	The average cost per player tested was comparable , with the average cost per player tested for the captain-led promotion estimated to be 88.99 compared with 88.33 for the sexual health advisor-led promotion and 81.87 for the poster-only ( control ) arm .
-CONCLUSIONS	Costs and outcomes were similar across intervention arms .
-CONCLUSIONS	The target sample size was not achieved , and we found a greater than anticipated variability between clubs in the acceptability of screening , which limited our ability to estimate acceptability for intervention arms .
-CONCLUSIONS	Further evidence is needed about the public health benefits associated with screening interventions in non-clinical settings so that their cost-effectiveness can be fully evaluated .
-
-###24660603
-OBJECTIVE	To explore the regulatory effects of established Chinese herbal formulas on inflammatory mediators released during asthma attacks , and to elucidate the molecular mechanism of Traditional Chinese Medicine in the treatment of asthma .
-METHODS	Seventy-five asthmatic children were randomly divided into a Chinese medication group ( 45 cases ) and a Western medication control group ( 30 cases ) .
-METHODS	Patients in the Chinese medication group were treated with a series of established Chinese herbal formulas , whereas the Western medication control group received a leukotriene receptor antagonist and a bronchial relaxant .
-METHODS	Real-time PCR was used to determine the mRNA expression levels of interleukin ( IL ) -4 , cysteinyl leukotriene receptor 1 ( CysLTR1 ) , and interferon ( IFN ) - gamma in peripheral blood mononuclear cells before and after treatment .
-METHODS	Enzyme-linked immunosorbent assay was used to measure the peripheral blood levels of IL-4 , leukotriene ( LTE ) -4 , and INF-gamma before and after treatment .
-RESULTS	After treatment , the mRNA expression levels of IL-4 and CysLTR1 were down-regulated ( P < 0.01 ) and the mRNA expression levels of IFN-gamma were up-regulated ( P < 0.05 ) in the Chinese medication and Western medication groups ; no significant difference was found between the two groups .
-RESULTS	In the Chinese medication group , IL-4 blood level was decreased and it was significantly different from that in the Western medication group ( P < 0.05 ) ; there was also a significant increase in IFN-gamma blood levels after treatment with Chinese medication ( P < 0.05 ) .
-RESULTS	There were no significant differences in LTE-4 blood levels between the two groups before and after treatment ( P > 0.05 ) .
-CONCLUSIONS	Chinese medication has a regulatory effect on leukotriene receptor gene expression and the imbalance of Th1/Th2 immune cells during asthma attacks in pediatric patients .
-
-###24725787
-OBJECTIVE	To determine inter-rater reliability in identifying a knee extension lag using the sitting active and prone passive lag test ( SAPLT ) .
-METHODS	56 patients with a diagnosis of knee pain were randomly assigned and independently examined by two physical therapists at a time , to determine the presence of an active or a passive extension lag at the knee .
-METHODS	An active lag was determined by the inability of the erectly seated subject to actively extend the involved knee in maximal dorsiflexion of the ankle to the same level as the normal knee held in maximal extension and ankle in maximal dorsiflexion , as seen by the levels of the toes .
-METHODS	A passive lag was determined by placing the subject prone with the knees just past the edge of the table and determining the high position of the heel in a fully resting extension position compared to the heel on the normal side .
-RESULTS	For the sitting active lag test , the inter-rater reliability was ` good ' ( Kappa 0.792 , SE of kappa 0.115 , 95 % confidence interval ) .
-RESULTS	For the prone passive lag test , the inter-rater reliability was ` good ' ( Kappa 0.636 , SE of kappa 0.136 , 95 % confidence interval ) .
-CONCLUSIONS	The SAPLT may be incorporated as a simple yet effective test to determine the presence of a knee extension lag .
-CONCLUSIONS	It identifies the type of restraint , active , passive or both , and is suggestive of the most appropriate management .
-
-###25274048
-BACKGROUND	In a large cluster-randomized trial on the impact of a prediction model , presenting the calculated risk of postoperative nausea and vomiting ( PONV ) on-screen ( assistive approach ) increased the administration of risk-dependent PONV prophylaxis by anaesthetists .
-BACKGROUND	This change in therapeutic decision-making did not improve the patient outcome ; that is , the incidence of PONV .
-BACKGROUND	The present study aimed to quantify the effects of adding a specific therapeutic recommendation to the predicted risk ( directive approach ) on PONV prophylaxis decision-making and the incidence of PONV .
-METHODS	A prospective before-after study was conducted in 1483 elective surgical inpatients .
-METHODS	The before-period included care-as-usual and the after-period included the directive risk-based ( intervention ) strategy .
-METHODS	Risk-dependent effects on the administered number of prophylactic antiemetics and incidence of PONV were analysed by mixed-effects regression analysis .
-RESULTS	During the intervention period anaesthetists administered 0.5 [ 95 % confidence intervals ( CIs ) : 0.4-0 .6 ] more antiemetics for patients identified as being at greater risk of PONV .
-RESULTS	This directive approach led to a reduction in PONV [ odds ratio ( OR ) : 0.60 , 95 % CI : 0.43-0 .83 ] , with an even greater reduction in PONV in high-risk patients ( OR : 0.45 , 95 % CI : 0.28-0 .72 ) .
-CONCLUSIONS	Anaesthetists administered more prophylactic antiemetics when a directive approach was used for risk-tailored intervention compared with care-as-usual .
-CONCLUSIONS	In contrast to the previously studied assistive approach , the increase in PONV prophylaxis now resulted in a lower PONV incidence , particularly in high-risk patients .
-CONCLUSIONS	When one aims for a truly ` PONV-free hospital ' , a more liberal use of prophylactic antiemetics must be accepted and lower-risk thresholds should be set for the actionable recommendations .
-
-###24601857
-OBJECTIVE	Several field triage systems have been developed to rapidly sort patients following a mass casualty incident ( MCI ) .
-OBJECTIVE	JumpSTART ( Simple Triage and Rapid Transport ) is a pediatric-specific MCI triage system .
-OBJECTIVE	SALT ( Sort , Assess , Lifesaving interventions , Treat/Transport ) has been proposed as a new national standard for MCI triage for both adult and pediatric patients , but it has not been tested in a pediatric population .
-OBJECTIVE	This pilot study hypothesizes that SALT is at least as good as JumpSTART in triage accuracy , speed , and ease of use in a simulated pediatric MCI .
-METHODS	Paramedics were invited and randomly assigned to either SALT or JumpSTART study groups .
-METHODS	Following randomization , subjects viewed a 15-minute PowerPoint lecture on either JumpSTART or SALT .
-METHODS	Subjects were provided with a triage algorithm card for reference and were asked to assign triage categories to 10 pediatric patients in a simulated building collapse .
-METHODS	The scenario consisted of 4 children in moulage and 6 high-fidelity pediatric simulators .
-METHODS	Injuries and triage categories were based on a previously published MCI scenario .
-METHODS	One investigator followed each subject to record time and triage assignment .
-METHODS	All subjects completed a post-test survey and structured interview following the simulated disaster .
-RESULTS	Forty-three paramedics were enrolled .
-RESULTS	Seventeen were assigned to the SALT group with an overall triage accuracy of 66 % 15 % , an overtriage mean rate of 22 16 % , and an undertriage rate of 10 9 % .
-RESULTS	Twenty-six participants were assigned to the JumpSTART group with an overall accuracy of 66 12 % , an overtriage mean of 23 16 % , and an undertriage rate of 11.2 11 % .
-RESULTS	Ease of use was not statistically different between the two systems ( median Likert value of both systems = 2 , p = 0.39 ) Time to triage per patient was statistically faster in the JumpSTART group ( SALT = 34 23 seconds , JumpSTART = 26 19 seconds , p = 0.02 ) .
-RESULTS	Both systems were prone to cognitive and affective error .
-CONCLUSIONS	SALT appears to be at least as good as JumpSTART in overall triage accuracy , overtriage , or undertriage rates in a simulated pediatric MCI .
-CONCLUSIONS	Both systems were considered easy to use .
-CONCLUSIONS	However , JumpSTART was 8 seconds faster per patient in time taken to assign triage designations .
-
-###25876348
-OBJECTIVE	To explore the clinical efficacy and effect mechanism on chronic urticaria treated with moving cupping therapy combined with autohemotherapy with acupaint injection for desensitization at acupoints .
-METHODS	One hundred and four patients of chronic urticaria were randomized into a comprehensive therapy group and a medication group , 52 cases in each one .
-METHODS	In the comprehensive therapy group , the moving cupping therapy along the governor vessel and bladder meridian of foot-taiyang was applied combined with autohemotherapy with acupaint injection for desensitization at acupoints .
-METHODS	The self-venous blood was injected at bilateral Quchi ( LI 11 ) and Zusanli ( ST 36 ) , 1 mL at each acupoint , once every 3 days .
-METHODS	In the medication group , cetirizine tablets , 10 mg were prescribed for oral administration , once every day , and the compound dexamethasone acetate cream was used externally , once to twice a day .
-METHODS	The clinical efficacy : was observed in 30 days of treatment in the two groups .
-METHODS	The changes of serum interleukin 4 ( IL-4 ) and immunoglobulin E ( Ig E ) before and after treatment were observed .
-METHODS	The recurrence rate was compared between the two groups in 3 months after treatment .
-RESULTS	The cured and markedly effective rate was 90.4 % ( 47/52 ) in the comprehensive therapy group , which was higher obviously than 78.8 % ( 41/52 , P < 0.05 ) in the medication group .
-RESULTS	The levels of serum IL-4 and IgE were reduced in the patients of the two groups , indicating the significant difference in comparison before and after treatment ( all P < 0.01 ) and the reducing degree in the comprehensive therapy group was much more significant than that in the medicine group ( both P < 0.01 ) .
-RESULTS	The recurrence rate was 19.1 % ( 9/47 ) in the comprehensive therapy group in the 3-month follow-up after treatment , and apparently lower than 51.2 % ( 21/41 , P < 0.01 ) .
-CONCLUSIONS	The moving cupping therapy combined with autohemotherapy with acupaint injection for desensitization at acupoints achieves the better efficacy on chronic urticaria compared with the routine western medicine treatment and the recurrence rate is low .
-CONCLUSIONS	The effect mechanism is possibly related to the down-regulation of serum IL-4 and IgE in the patients .
-
-###24469141
-OBJECTIVE	To investigate the education effect of case-based learning ( CBL ) pattern on clinical internship of conservative dentistry and endodontics .
-METHODS	Forty-one undergraduates were randomly assigned into CBL group and traditional teaching group .
-METHODS	After clinical internship in the department of conservative dentistry and endodontics for 11 weeks , each student in the 2 groups underwent comprehensive examinations including medical record writing , case analysis , academic knowledge , professional skills and the ability of winning the trust of the patients .
-METHODS	The scores were compared between the 2 groups using SPSS 13.0 software package .
-RESULTS	There was no significant difference between the 2 groups with regard to the scores of academic knowledge and profession skills ( P > 0.05 ) .
-RESULTS	However , the results of medical record writing , case analysis and the ability of winning the trust of the patients showed significant difference between the 2 groups ( P < 0.05 ) .
-CONCLUSIONS	Proper application of CBL in clinical internship of conservative dentistry and endodontics contributes to improve students ' ability of clinical thinking , synthetical analysis and adaptability to different patients .
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-###25016303
-BACKGROUND	People with dementia living in care homes often have complex mental health problems , disabilities and social needs .
-BACKGROUND	Providing more comprehensive training for staff working in care home environments is a high national priority .
-BACKGROUND	It is important that this training is evidence based and delivers improvement for people with dementia residing in these environments .
-BACKGROUND	Well-being and Health for People with Dementia ( WHELD ) combines the most effective elements of existing approaches to develop a comprehensive but practical staff training intervention .
-BACKGROUND	This optimised intervention is based on a factorial study and qualitative evaluation , to combine : training on person-centred care , promoting person-centred activities and interactions , and providing care home staff and general practitioners with updated knowledge regarding the optimal use of psychotropic medications for persons with dementia in care homes .
-METHODS	The trial will be a randomised controlled two-arm cluster single blind trial that will take place for nine months across 80 care homes in the United Kingdom .
-CONCLUSIONS	The overarching goal of this trial is to determine whether this optimised WHELD intervention is more effective in improving the quality of life and mental health than the usual care provided to people with dementia living in nursing homes .
-CONCLUSIONS	This study will be the largest and best powered randomised controlled trial ( RCT ) evaluating the benefits of an augmented person-centred care training intervention in care homes worldwide .
-BACKGROUND	Current controlled trials ISRCTN62237498 Date registered : 5 September 2013 .
-
-###26237979
-OBJECTIVE	To observe the clinical effect of slow-rapid reinforcing-reducing needling manipulation at Jiaji ( EX-B 2 ) acupoint for lumbar intervertebral disc protrusion .
-METHODS	Sixty subjects met the inclusion criteria of disc herniation were randomly divided into treatment group ( n = 30 ) and control group ( n = 30 ) .
-METHODS	In the treatment group , the stimulation mode ( slow or fast , reinforcement or reduction ) of Jiaji acupoints ( EX-B 2 ) was based on the status of the patients by an overall analysis of symptoms and signs .
-METHODS	Other acupoints such as Huantiao ( GB 30 ) , Weizhong ( BL 40 ) , etc. were stimulated with uniform reinforcing-reducing manipulation .
-METHODS	In the control group , all the acupoints were stimulated in uniform reinforcing-reducing mode .
-METHODS	The treatment was conducted once a day , continuously for 18 days with 1 day 's break between every 6 days .
-METHODS	The clinical efficacy appraisal , visual analogue scale ( VAS ) and Japanese orthopaedic association ( JOA ) scores and traditional Chinese medicine ( TCM ) syndrome scores were used for outcome assessment .
-RESULTS	In comparison with pretreatment , the VAS scores and TCM syndrome scores were significantly decreased in both control and treatment groups ( P < 0.05 ) , and the JOA scores were markedly increased after the treatment ( P < 0.05 ) .
-RESULTS	The therapeutic effects of the treatment group were obviously superior to those of the control group in down-regulating the VAS score and TCM syndome score and up-regulating JOA score ( P < 0.05 ) .
-CONCLUSIONS	Slow-fast reinforcing-reducing needling manipulation is superior to the routine acupuncture in the management of lumbar intervertebral disc protrusion .
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-###24527853
-BACKGROUND	There are limited clinical experiments addressing the effects of photodynamic therapy ( PDT ) as an adjunct to conventional scaling and root planing ( SRP ) on clinical and biologic features of periodontitis .
-BACKGROUND	This trial compares the clinical parameters and cytokine profiles in gingival crevicular fluid of patients with moderate-to-severe chronic periodontitis ( CP ) who have been treated using SRP alone or SRP + PDT .
-METHODS	Twenty-two patients with two contralateral teeth affected with moderate-to-severe CP were selected .
-METHODS	After SRP , the participants ' teeth were randomized to receive either no further treatment or a single application of PDT using a 638-nm laser and toluidine blue .
-METHODS	Although the change in probing depth was the primary outcome , bleeding on probing , clinical attachment level , gingival recession , interleukin-1 , tumor necrosis factor ( TNF ) - , and matrix metalloproteinase 8 and 9 were also evaluated at baseline and 3 months postintervention .
-METHODS	An oral rinse assay was also performed to determine the total levels of oral polymorphonuclear cells ( PMNs ) before and 3 months after the treatments .
-RESULTS	Within each group , significant improvements ( P < 0.001 ) were found for all variables in 3-month follow-up compared with baseline .
-RESULTS	Only TNF - was significantly improved in the PDT + SRP versus SRP group .
-RESULTS	Total levels of PMNs were reduced for all patients compared with baseline levels ( P < 0.001 ) .
-CONCLUSIONS	In patients with CP , a single application of PDT ( using a 638-nm laser and toluidine blue ) did not provide any additional benefit to SRP in terms of clinical parameters or inflammatory markers 3 months following the intervention .
-
-###24565123
-OBJECTIVE	The combination of ketamine and remifentanil seems to be associated with better analgesia and duration .
-OBJECTIVE	The aim of this study was to evaluate whether a ketamine - remifentanil combination promotes improved postoperative analgesia .
-METHODS	Prospective , randomized , double blind study of 40 patients undergoing video laparoscopic cholecystectomy .
-METHODS	Anesthesia was performed with remifentanil , propofol , atracurium , and 50 % oxygen .
-METHODS	Group 1 ( GI ) patients received remifentanil ( 0.4 mcg.kg ( -1 ) .
-METHODS	min ( -1 ) ) and ketamine ( 5 mcg.kg ( -1 ) .
-METHODS	min ( -1 ) ) and Group 2 ( G2 ) received remifentanil ( 0.4 mcg.kg ( -1 ) .
-METHODS	min ( -1 ) ) and saline solution .
-METHODS	Morphine 0.1 mg.kg ( -1 ) was administered at the end of the procedure , and postoperative pain was treated with morphine via PCA .
-METHODS	We evaluated the severity of postoperative pain by a numerical scale from zero to 10 during 24 hours .
-METHODS	We registered the time to the first analgesic supplementation , amount of morphine used in the first 24 hours , and adverse effects .
-RESULTS	There was a decrease in pain severity between extubation and other times evaluated in G1 and G2 .
-RESULTS	There was no significant difference in pain intensity between the groups .
-RESULTS	There was no difference between G1 ( 22 24.9 min ) and G2 ( 21.5 28.1 min ) regarding time to first dose of morphine and dose supplement of morphine consumed in G1 ( 29 18.4 mg ) and G2 ( 25.1 13.3 mg ) .
-CONCLUSIONS	The combination of ketamine ( 5 mcg.kg ( -1 ) .
-CONCLUSIONS	min ( -1 ) ) and remifentanil ( 0.4 mcg.kg ( -1 ) .
-CONCLUSIONS	min ( -1 ) ) for cholecystectomy did not alter the severity of postoperative pain , time to first analgesic supplementation or dose of morphine in 24 hours .
-
-###24812898
-OBJECTIVE	To observe the efficacy of integrative medical sequential method in treating cerebral palsy ( CP ) children 's intelligence development , muscular tension , serum interleukin 6 ( IL-6 ) , and tumor necrosis factor alpha ( TNF-alpha ) .
-METHODS	Totally 111 CP children were randomly assigned to the control group ( 50 cases ) and the treatment group ( 61 cases ) .
-METHODS	All patients received comprehensive rehabilitation training and intravenous dripping of Monosialotetrahexosylganglioside Sodium Injection for 10 days .
-METHODS	But those in the treatment group additionally received Chinese medical enema for brain resuscitation , relieving rigidity of muscles and activating collaterals for 14 days .
-METHODS	Then they started another medication cycle and lasted for a total of 6 cycles .
-METHODS	Serum IL-6 levels and TNF-alpha contents were determined before treatment .
-METHODS	Scoring for muscular tension , Gesell score for intelligence development , contents of serum IL-6 and TNF-alpha were assessed before and after treatment in the two groups .
-RESULTS	Compared with before treatment in this group , muscular tension , Gesell scores for intelligence development all decreased in the two groups ( P < 0.05 ) .
-RESULTS	As for inter-group comparison , the decrement was more obvious in the treatment group than in the control group ( P < 0.05 ) .
-RESULTS	The total effective rate was 86.9 % in the treatment group and 76.0 % in the control group ( P < 0.05 ) .
-RESULTS	The contents of IL-6 and TNF-alpha were obviously reduced in the treatment group and the control group after treatment ( P < 0.01 ) .
-RESULTS	The decrement was more obvious in the treatment group ( P < 0.05 ) .
-CONCLUSIONS	The two treatment methods were effective for CP children , but the efficacy was superior in the treatment group than in the control group , indicating integrative medical methods could play a synergistic effect and optimize the treatment program for CP .
-
-###25879524
-BACKGROUND	A post-hoc analysis was performed on the data from a 54weeks phase III study ( ClinicalTrials.gov identifier : NCT00923091 ) to measure changes in the health-related quality of life ( HRQoL ) of 2,690 patients aged 18 with moderate-to-severe hypertension who received one of six doses of olmesartan/amlodipine/hydrochlorothiazide ( OLM/AML/HCTZ ) , using the MINICHAL and EQ-5D instruments .
-METHODS	Descriptive statistics were used to assess blood pressure and HRQoL scores over the study period .
-METHODS	Analysis of covariance ( ANCOVA ) was used to identify those factors that could possibly have influenced HRQoL .
-METHODS	Linear regression was used to assess the relationship between changes in blood pressure and HRQoL scores .
-RESULTS	Patients ' baseline MINICHAL mood and somatic domains scores were 5.5 and 2.6 .
-RESULTS	Over the study period HRQoL improved as both MINICHAL scores decreased by 31-33 % .
-RESULTS	Patients ' baseline EQ-5D index and VAS scores were 0.9 and 73.4 respectively , increasing by 6 % and 12 % over the study period .
-RESULTS	Patients ' QALY gain over the 54weeks study period was estimated to be 0.029 QALYs .
-RESULTS	The ANCOVA showed that changes in patients ' HRQoL was likely to have been influenced by patients ' achievement of blood pressure control , the amount of concomitant medication and patients ' last used dosage strength of antihypertensive .
-RESULTS	Linear regression showed that blood pressure improvement may have been associated with improved HRQoL .
-CONCLUSIONS	This study showed that OLM/AML/HCTZ reduced blood pressure and significantly increased blood pressure control whilst improving patients ' HRQoL .
-CONCLUSIONS	Achieving blood pressure control , amount of concomitant medication and dosage strength of antihypertensive impacted on patients ' HRQoL .
-
-###24583820
-BACKGROUND	The effect of anaesthetic drugs on long-term oncological outcomes after cancer surgery is an area of current interest .
-BACKGROUND	Dexamethasone is widely used in anaesthetic practice ; however , its effect on long-term survival and cancer outcomes is not known .
-BACKGROUND	This study presents the results of a 5-yr follow-up of patients receiving dexamethasone before elective colectomy as part of a previous randomized clinical trial .
-METHODS	Sixty patients who underwent elective open colonic resection for any indication between June 2006 and March 2008 were randomized to receive either 8 mg i.v. dexamethasone or placebo before surgery .
-METHODS	A 5-yr follow-up analysis was conducted to evaluate overall survival , disease-free survival and recurrence specifically for patients undergoing resection for Stage I-III colon cancer .
-METHODS	Kaplan-Meier analysis was performed and log-rank test was used to evaluate difference in survival between groups .
-RESULTS	Forty-three of the 60 subjects had Stage I-III colon cancer and were included in the follow-up analysis .
-RESULTS	Twenty received preoperative dexamethasone and 23 received placebo .
-RESULTS	There were no significant differences between groups in baseline or disease characteristics .
-RESULTS	No differences were found between groups for overall or disease-free survival .
-RESULTS	In the dexamethasone group , there was a significantly higher rate of distant recurrence ( 6 compared with 1 , P = 0.04 ) .
-CONCLUSIONS	Preoperative dexamethasone was associated with a higher rate of distant recurrence in patients undergoing colectomy for colon cancer .
-CONCLUSIONS	Given the small sample size , this finding should be interpreted with caution , but warrants further investigation in a prospective study .
-
-###24432712
-BACKGROUND	The EXAcerbations of Chronic Pulmonary Disease Tool ( EXACT ) is a patient-reported outcome measure to standardize the symptomatic assessment of chronic obstructive pulmonary disease exacerbations , including reported and unreported events .
-BACKGROUND	The instrument has been validated in a short-term study of patients with acute exacerbation and stable disease ; its performance in longer-term studies has not been assessed .
-OBJECTIVE	To test the EXACT 's performance in three randomized controlled trials and describe the relationship between resource-defined medically treated exacerbations ( MTEs ) and symptom ( EXACT ) - defined events .
-METHODS	Prespecified secondary analyses of data from phase II randomized controlled trials testing new drugs for the management of chronic obstructive pulmonary disease : one 6-month trial ( United States ) ( n = 235 ) and two 3-month , multinational trials ( AZ 1 [ n = 749 ] , AZ 2 [ n = 597 ] ) .
-METHODS	In each case , the experimental drugs were found to be ineffective , permitting assessment of the EXACT 's performance in three independent studies of moderate to severe high-risk patients on maintenance therapies .
-RESULTS	The mean age of subjects was 62 to 64 years ; 48 to 76 % were male .
-RESULTS	Mean FEV1 % predicted was 42 to 59 % .
-RESULTS	EXACT scores exhibited internal consistency ( Cronbach 's 0.90 ) , reproducibility ( intraclass correlation 0.70 ) , correlation with St. George 's Respiratory Questionnaire ( Spearman rho [ rs ] = 0.62 , 0.46 , 0.46 in the three trials ; P < 0.001 ) , and Breathlessness Cough and Sputum Scale ( AZ 1 , rs = 0.83 ; AZ 2 , rs = 0.83 ; P < 0.001 ) .
-RESULTS	EXACT-defined events had a high correspondence with alternative indicators of worsening ( 94 , 88 , and 93 % ) .
-RESULTS	In each trial , unreported events were similar in severity ( mean EXACT score , 56 , 57 , 61 vs. 53 , 54 [ P < 0.05 ] , 57 [ P < 0.05 ] , respectively ; 100-point scale ) and longer ( median , 9 , 8 , 7 vs. 8 , 7 [ P < 0.01 ] , 6 days , respectively ) than moderate MTEs .
-CONCLUSIONS	Data generated through the EXACT offers insight into the symptomatic nature of MTEs and the frequency , severity , and duration of unreported symptom-defined events .
-CONCLUSIONS	Clinical trials registered with www.clinicaltrials.gov ( MPEX : NCT00739648 ; AZ 1 : NCT00949975 ; AZ 2 : NCT01023516 ) .
-
-###24621686
-BACKGROUND	Complex regional pain syndrome is multifactorial .
-BACKGROUND	Exaggerated inflammatory responses to limb injury may be involved .
-BACKGROUND	The authors hypothesized that capsaicin-induced pain and neurogenic inflammation ( skin perfusion and flare area ) are increased in patients with complex regional pain syndrome compared with that in controls .
-METHODS	Twenty patients with unilateral upper-limb complex regional pain syndrome and 20 age - , sex - , and body mass index-matched controls participated .
-METHODS	Topical capsaicin 5 % was applied to the back of both hands for 30 min , and pain intensity was assessed on a visual analogue scale .
-METHODS	A laser Doppler perfusion imager scanner estimated capsaicin-induced skin perfusion and flare area .
-METHODS	Autonomic and small-fiber function was assessed by sensory testing , quantitative sudomotor axon reflex test , and vasoconstrictor responses .
-RESULTS	The authors found bilateral hypersensitivity to capsaicin ( P 0.02 ) , skin fold ( P = 0.001 ) , joint pressure ( P < 0.0001 ) , cold ( P 0.01 ) , and heat pain ( P 0.04 ) in patients compared with that in controls and thermal and mechanical hyperalgesia in the complex regional pain syndrome-affected hand compared with that in the unaffected hand ( P 0.001 ) .
-RESULTS	The patients had normal capsaicin-induced flare areas , thermal detection thresholds , quantitative sudomotor axon reflex test , and vasoconstrictor responses .
-CONCLUSIONS	The main finding is bilaterally increased capsaicin-induced pain in patients compared with controls .
-CONCLUSIONS	The flare response to capsaicin was normal , suggesting that the increased pain response was not due to increased neurogenic inflammation .
-CONCLUSIONS	The bilateral hypersensitivity to painful chemical , thermal , and mechanical stimuli not confined to the innervation area of a peripheral nerve or root can not be explained by a regional change and may partly be due to central sensitization .
-
-###25037883
-BACKGROUND	Diurnal variation in serum growth hormone ( s-GH ) levels after exogenous GH delivery has previously been reported in patients with no endogenous GH secretion .
-BACKGROUND	Changes in postural position or physical activity , leading to changes in blood flow and/or lymphatic drainage may be underlying explanations .
-OBJECTIVE	The primary aim of this study is to study a possible impact of exercise and supine rest on pharmacokinetics ( PK ) and day-to-day variation of subcutaneously ( s.c. ) administered GH in adult GH deficient ( AGHD ) patients .
-OBJECTIVE	The secondary aim of this study is to compare s-IGF-I , s-insulin , and plasma ( p ) - glucose profiles after a carbohydrate rich breakfast following s.c. GH injection vs. continuous infusion .
-METHODS	During supine rest eight AGHD males ( 59.88 years , BMI 29.74.9 kg/m ( 2 ) ) were treated with one daily s.c. GH injections of 3 mg/24 h for 48 h ( treatment sessions A , B ) or a continuous s.c. GH infusion of 3 mg/24 h for 60 h ( treatment sessions C , D ) .
-METHODS	Exercise comprised 1 h bicycling with 50 W load on two consecutive days during treatment sessions B and D.
-RESULTS	Administration of GH as a bolus injection , but not as a continuous GH infusion , resulted in about 32 % higher s-GH levels during exercise ( 60 min ) as well as 30 min after ( s-GH logAUC ( B-A ) difference was 0.28 ; 95 % CI : 0.14-0 .4 ; p < 0.001 ) .
-RESULTS	However , the total s-GH ( AUC 0-24 h ) ( p = 0.75 ) and s-IGF-I ( AUC0-48 h ) levels ( p = 0.51 ) remained unchanged between the two occasions .
-RESULTS	P-glucose and insulin profiles were significantly higher after carbohydrate rich breakfast before first and second dosing both following s.c. GH injection and continuous infusion ( p < 0.05 ) .
-CONCLUSIONS	Moderate exercise intermittently increased s-GH levels .
-CONCLUSIONS	These changes seem to have no clinical short-term relevance , since total s-GH ( 24 h ) and s-IGF-I ( 48 h ) levels were unaffected .
-
-###24420155
-OBJECTIVE	The purpose of this prospective , randomised study was to evaluate long-term clinical results , radiographic findings , complications and revision and survivorship rates in patients < 55 years at a minimum of 16 years after undergoing bilateral , sequential , simultaneous , cemented and cementless total knee arthroplasties ( TKAs ) in the same patients .
-METHODS	Bilateral , sequential , simultaneous TKAs were performed in 80 patients ( 160 knees ) .
-METHODS	There were 63 women and 17 men with a mean age of 54.3 years ( range 49-55 ) , who received a cementless prosthesis in one knee and a cemented prosthesis in the other .
-METHODS	The mean follow-up was 16.6 years ( range 16-17 ) .
-RESULTS	At final review , the mean Knee Society ( KS ) knee scores ( 95.8 versus 96.9 ) , Western Ontario and McMaster Universities ( WOMAC ) osteoarthritis ( OA ) index ( 25.4 versus 25.9 ) , range of motion ( ROM ) ( 125 versus 128 ) , patient satisfaction ( 8.1 versus 8.3 ) and radiological results were similar in both groups .
-RESULTS	Femoral component survival rate was 100 % in both groups at 17 years ; at 17 years , the cemented tibial component survival rate was 100 % and the cementless tibial component 98.7 % .
-RESULTS	No osteolysis was identified in either group .
-CONCLUSIONS	Long-term results of both cementless and cemented TKAs were encouraging in patients with OA who were < 55 years .
-CONCLUSIONS	However , we found no evidence to prove the superiority of cementless over cemented TKAs .
-
-###25022777
-OBJECTIVE	To assess the relationship between session-by-session mediators and treatment outcomes in traditional cognitive-behavioral therapy ( CBT ) and acceptance and commitment therapy ( ACT ) for social anxiety disorder .
-METHODS	Session-by-session changes in negative cognitions ( a theorized mediator of CBT ) and experiential avoidance ( a theorized mediator of ACT ) were assessed in 50 adult outpatients randomized to CBT ( n = 25 ) or ACT ( n = 25 ) for DSM-IV social anxiety disorder .
-RESULTS	Multilevel modeling analyses revealed significant nonlinear decreases in the proposed mediators in both treatments , with ACT showing steeper decline than CBT at the beginning of treatment and CBT showing steeper decline than ACT at the end of treatment .
-RESULTS	Curvature ( or the nonlinear effect ) of experiential avoidance during treatment significantly mediated posttreatment social anxiety symptoms and anhedonic depression in ACT , but not in CBT , with steeper decline of the Acceptance and Action Questionnaire at the beginning of treatment predicting fewer symptoms in ACT only .
-RESULTS	Curvature of negative cognitions during both treatments predicted outcome , with steeper decline of negative cognitions at the beginning of treatment predicting lower posttreatment social anxiety and depressive symptoms .
-CONCLUSIONS	Rate of change in negative cognitions at the beginning of treatment is an important predictor of change across both ACT and CBT , whereas rate of change in experiential avoidance at the beginning of treatment is a mechanism specific to ACT .
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-###25011612
-BACKGROUND	Although the benefits of physical activity ( PA ) on to prevent and manage non-communicable diseases are well known , strategies to help increase the levels of PA among different populations are limited .
-BACKGROUND	Exercise-referral schemes have emerged as one effective approach to promote PA ; however , there is uncertainty about the feasibility and effectiveness of these schemes in settings outside high-income countries .
-BACKGROUND	This study will examine the effectiveness of a scheme to refer hypertensive patients identified in Primary Health Care facilities ( PHCU ) of the Mexican social security institution to a group PA program offered in the same institution .
-METHODS	We will describe the methods of a cluster randomized trial study designed to evaluate the effectiveness of an exercise referral scheme to increasing physical activity in hypertensive patients compared to a non-referral scheme .
-METHODS	Four PHCU were selected for the study ; the PHCU will take part as the unit of randomization and sedentary hypertensive patients as the unit of assessment .
-METHODS	2 PHCU of control group ( GC ) will provide information to hypertensive patients about physical activity benefits and ways to increase it safely .
-METHODS	2 PHCU of intervention group ( IG ) will refer patients to sports facilities at the same institution , to follow a group-based PA program developed to increase the PA levels with a designed based on the Transtheoretical Model and Social Cognitive Theory .
-METHODS	To evaluate the effects of the intervention as well as short-term maintenance of the intervention 's effects , PA will be assessed at baseline , at 24 and 32 weeks of follow-up .
-METHODS	The main outcome will be the difference before and after intervention in the percentage of participants meeting recommended levels of PA between and within intervention and control groups .
-METHODS	PA will be measured through self-report and with objective measure by accelerometer .
-CONCLUSIONS	This study will allow us to evaluate a multidisciplinary effort to link the primary care and community-based areas of the same health care system .
-CONCLUSIONS	Our findings will provide important information about the feasibility and effectiveness of an exercise-referral scheme and will be useful for decision-making about the implementation of strategies for increasing PA among hypertensive and other clinical populations in Mexico and Latin America .
-BACKGROUND	Clinicaltrials.gov Identifier : NCT01910935 .
-BACKGROUND	Date of registration : 07/05/2013 .
-
-###24719046
-OBJECTIVE	Rheumatoid arthritis ( RA ) patients display high levels of oxidative stress .
-OBJECTIVE	Transient exercise-induced increases in oxidative stress are thought to be adaptive in healthy populations .
-OBJECTIVE	This study investigated the effect of exercise on markers of oxidative stress in RA , following acute exercise and a period of exercise training .
-METHODS	Acute exercise study : RA patients ( N = 12 , age : 5611 ) undertook a bout of exercise ( 30-40min , 70 % VO2MAX ) , and blood samples were taken before and after exercise to assess markers of oxidative stress .
-METHODS	Training study : RA patients ( N = 19 , age : 5610 ) were randomised into either a control or exercise group , who undertook 3 exercise sessions per week ( 30-40min @ 70 % VO2MAX ) for 3months .
-METHODS	Plasma markers of oxidative stress ( protein carbonyls ( PC ) , lipid hydroperoxides ( LOOH ) , 3-nitrotyrosine ( 3-NT ) , total antioxidant capacity ( TAC ) and catalase ( CAT ) activity ) , inflammation ( interleukin-8 ( IL-8 ) and C-reactive protein ( CRP ) ) and nitric oxide metabolites ( NOx ) were assessed before and after training .
-RESULTS	Acute exercise study : Protein carbonyls ( PC ) ( +18 % ) and NOx ( +27 % ) were significantly increased following exercise .
-RESULTS	Training study : 3-nitrotyrosine ( 3-NT ) decreased ( 2.181.78 to 1.100.93 M ) in the exercise group only , alongside increases in aerobic fitness ( 24.454.98 to 27.104.51 ml/kg/min ( -1 ) ) and reductions in disease activity score ( DAS : 3.471.17 to 2.880.76 ) .
-RESULTS	PC , LOOH , TAC , IL-8 , CRP and NOx concentrations , and CAT activity were unchanged in both groups .
-CONCLUSIONS	Aerobic exercise training did not increase markers of oxidative stress in RA patients .
-CONCLUSIONS	3-Nitrotyrosine and disease activity were decreased following exercise training .
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-###25019632
-BACKGROUND	The application of internet technology for telerehabilitation in patients with stroke has developed rapidly .
-OBJECTIVE	The current study aimed to evaluate the effect of a bidirectional and multi-user telerehabilitation system on balance and satisfaction in patients with chronic stroke living in long-term care facilities ( LTCFs ) .
-METHODS	This pilot study used a multi-site , blocked randomization design .
-METHODS	Twenty-four participants from three LTCFs were recruited , and the participants were randomly assigned into the telerehabilitation ( Tele ) and conventional therapy ( Conv ) groups within each LTCF .
-METHODS	Tele group received telerehabilitation but the Conv group received conventional therapy with two persons in each group for three sessions per week and for four weeks .
-METHODS	The outcome measures included Berg Balance Scale ( BBS ) , Barthel Index ( BI ) , and the telerehabilitation satisfaction of the participants .
-METHODS	A telerehabilitation system included `` therapist end '' in a laboratory , and the `` client end '' in LTCFs .
-METHODS	The conventional therapy was conducted in LTCFs .
-RESULTS	Training programs conducted for both the Tele and Conv groups showed significant effects within groups on the participant BBS as well as the total and self-care scores of BI .
-RESULTS	No significant difference between groups could be demonstrated .
-RESULTS	The satisfaction of participants between the Tele and the Conv groups also did not show significant difference .
-CONCLUSIONS	This pilot study indicated that the multi-user telerehabilitation program is feasible for improving the balance and functional activity similar to conventional therapy in patients with chronic stroke living in LTCFs .
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-###24312382
-BACKGROUND	The reward value of food is partly dependent on learned associations .
-BACKGROUND	It is not yet known whether replacing sugar with non-caloric sweeteners in food is affecting long-term acceptance .
-OBJECTIVE	To determine the effect of replacing sugar with non-caloric sweeteners in a nutrient-empty drink ( soft drink ) versus nutrient-rich drink ( yoghurt drink ) on reward value after repeated exposure .
-METHODS	We used a randomized crossover design whereby forty subjects ( 15 men , 25 women ) with a mean SD age of 21 2 y and BMI of 21.5 1.7 kg/m ( 2 ) consumed a fixed portion of a non-caloric sweetened ( NS ) and sugar sweetened ( SS ) versions of either a soft drink or a yoghurt drink ( counterbalanced ) for breakfast which were distinguishable by means of colored labels .
-METHODS	Each version of a drink was offered 10 times in semi-random order .
-METHODS	Before and after conditioning the reward value of the drinks was assessed using behavioral tasks on wanting , liking , and expected satiety .
-METHODS	In a subgroup ( n = 18 ) fMRI was performed to assess brain reward responses to the drinks .
-RESULTS	Outcomes of both the behavioral tasks and fMRI showed that conditioning did not affect the reward value of the NS and SS versions of the drinks significantly .
-RESULTS	Overall , subjects preferred the yoghurt drinks to the soft drinks and the ss drinks to the NS drinks .
-RESULTS	In addition , they expected the yoghurt drinks to be more satiating , they reduced hunger more , and delayed the first eating episode more .
-RESULTS	Conditioning did not influence these effects .
-CONCLUSIONS	Our study showed that repeated consumption of a non-caloric sweetened beverage , instead of a sugar sweetened version , appears not to result in changes in the reward value .
-CONCLUSIONS	It can not be ruled out that learned associations between sensory attributes and food satiating capacity which developed preceding the conditioning period , during lifetime , affected the reward value of the drinks .
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-###24439713
-OBJECTIVE	We test the hypothesis that anesthesia , measured as pain scores , induced by a novel topical anesthetic putty is non-inferior ( margin = 1.3 ) to that provided by conventional lidocaine infiltration for the repair of lacerations .
-METHODS	A randomized controlled trial was conducted in the emergency department ( ED ) of a local hospital .
-METHODS	Participants were randomly allocated to receive either infiltration anesthesia or topical anesthetic putty as per the trial protocol .
-METHODS	Pain scores were recorded 15 minutes after infiltration and 30 minutes after topical anesthetic putty application .
-METHODS	Median pain scores were compared between groups .
-METHODS	Wound evaluation scores were conducted after 7 to 10 days and adverse events were monitored for both groups of participants throughout the study .
-RESULTS	One hundred and ten participants were enrolled in the study , with 56 receiving infiltration and 54 receiving topical anesthetic putty .
-RESULTS	The median difference between the pain scores of the 2 groups was 0 ( 95 % confidence interval -1 to 0 ) .
-RESULTS	There were no substantial differences between the 2 groups in terms of either the wound evaluation scores or the incidence of adverse events .
-CONCLUSIONS	The novel topical anesthetic putty was not inferior to infiltration with lidocaine with respect to the pain experienced during suturing , and this putty is a feasible alternative to infiltration anesthesia of lacerations in the ED .
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-###25529948
-OBJECTIVE	To explore the value of preoperative evaluation with three-dimensional endoanal ultrasonography ( 3D-EAUS ) for anal fistula in order to provide preoperative assessment for anal fistula .
-METHODS	One hundred patients diagnosed with anal fistula undergoing surgery between March 2012 and March 2013 in our department were prospectively enrolled .
-METHODS	All the patients were randomly divided into the ultrasound group and the control group with fifty patients in each group .
-METHODS	The ultrasound group received 3D-EAUS and the control group received routine examinations ( digital examination and probe ) to assess the position of the internal opening , the type of fistula and secondary tracks , respectively .
-METHODS	The concordance rate of the preoperative assessment and intraoperative exploration was evaluated between the two groups .
-RESULTS	The accuracy of identifying internal opening was 96.0 % for the ultrasound group and 82.0 % for the control group with statistically significant difference ( P = 0.02 ) .
-RESULTS	The accuracy of identifying internal opening for simple anal fistula was similar ( 95.0 % vs. 91.3 % , P = 1 ) .
-RESULTS	For complex anal fistula , the accuracy was also higher in the ultrasound group ( 96.7 % vs. 74.1 % , P = 0.025 ) .
-RESULTS	The accuracy of fistula classification was 78.0 % for the ultrasound group and 96.0 % for the control group with significant difference ( P = 0.01 ) .
-RESULTS	The accuracy of identifying a second track was higher in the ultrasound group ( 96.0 % vs. 82.0 % , P = 0.025 ) .
-CONCLUSIONS	It is significantly superior for 3D-EAUS to detect the internal opening , fistula classification and identification of a second track in complex anal fistulas as compared to conventional examination .
-CONCLUSIONS	3D-EAUS should be recommended as a preoperative assessment for anal fistula , especially for complex one .
-
-###26225442
-OBJECTIVE	The quality of integrated diabetes care is important for reducing the burden of diabetes .
-OBJECTIVE	Therefore , we have evaluated the effect of a supervision program on the quality of integrated diabetes care in the Netherlands in the 2011-2012 period .
-METHODS	In this cluster RCT , the supervision program was assigned to randomly selected care groups providing care to diabetes patients .
-METHODS	The supervision program included announcements of inspections , site visits , and sending individualized reports .
-METHODS	Indicators of effectiveness were derived from the structures , processes , and outcomes of care .
-METHODS	These indicators were collected from patients ' files , before and after the supervision program .
-METHODS	Hierarchical linear and logistic regression models were used to analyze data from 356 patients of 10 intervention and 8 control care groups .
-RESULTS	Structures and processes of care did not improve more in the intervention groups than in the control care groups .
-RESULTS	Moreover , health outcomes did not improve more in the intervention groups than in the control care groups .
-RESULTS	Although structures of care improved over time in the total population of intervention and control care groups , there were no changes in process of care or health outcomes .
-CONCLUSIONS	In this cluster RCT , we could not demonstrate improvements in quality of integrated diabetes care resulting from the supervision program .
-CONCLUSIONS	Although structures of care did improve over time , other quality-improvement initiatives are necessary to substantially strengthen integrated care for diabetes patients .
-
-###25807408
-BACKGROUND	Following a major burn , skeletal muscle protein synthesis rate increases but is often insufficient to compensate for massively elevated muscle protein breakdown rates .
-BACKGROUND	Given the long-term nature of the pathophysiologic response to burn injury , we hypothesized that muscle protein synthesis rate would be chronically elevated in severely burned children .
-BACKGROUND	The objectives of this study were to characterize muscle protein synthesis rate of burned children over a period of 24 months after injury and to identify predictors that influence this response .
-METHODS	A total of 87 children with 40 % or greater total body surface area ( TBSA ) burned were included .
-METHODS	Patients participated in stable isotope infusion studies at 1 , 2 , and approximately 4 weeks after burn and at 6 , 12 , and 24 months after injury to determine skeletal muscle protein fractional synthesis rate .
-METHODS	Generalized estimating equations with log link normal distribution were applied to account for clustering of patients and control for patient characteristics .
-RESULTS	Patients ( 8 6 years ) had large ( 62 , 51-72 % TBSA ) and deep ( 47 % 21 % TBSA third degree ) burns .
-RESULTS	Muscle protein fractional synthesis rate was elevated throughout the first 12 months after burn compared with established values from healthy young adults .
-RESULTS	Muscle protein fractional synthesis rate was lower in boys , in children older than 3 years , and when burns were greater than 80 % TBSA .
-CONCLUSIONS	Muscle protein synthesis is elevated for at least 1 year after injury , suggesting that greater muscle protein turnover is a component of the long-term pathophysiologic response to burn trauma .
-CONCLUSIONS	Muscle protein synthesis is highly affected by sex , age , and burn size in severely burned children .
-CONCLUSIONS	These findings may explain the divergence in net protein balance and lean body mass in different populations of burn patients .
-METHODS	Prognostic study , level III .
-
-###25754845
-BACKGROUND	In this study , we evaluated long-term survival in patients treated with and without mechanical bowel preparation ( MBP ) before colorectal surgery for cancer .
-METHODS	Long-term outcome of patients of 2 main participating hospitals in a prior multicenter randomized trial comparing clinical outcome of MBP versus no MBP was reviewed .
-METHODS	Primary endpoint was cancer-related mortality and secondary endpoint was all-cause mortality .
-RESULTS	A total of 382 patients underwent potentially curative surgery for colorectal cancer .
-RESULTS	One hundred seventy-seven ( 46 % ) patients were treated with MBP and 205 ( 54 % ) were not before surgery .
-RESULTS	Median follow-up was 7.6 years ( mean 6.6 , range .01 to 12.73 ) .
-RESULTS	There was no significant difference in both cancer-related mortality and all-cause mortality in patients treated with MBP and without MBP ( P = .76 and P = .36 , respectively ) .
-RESULTS	Multivariate analysis , taking account of age , sex , AJCC cancer stage , and ASA classification , also showed no survival difference .
-CONCLUSIONS	Our results indicate that MBP does not seem to influence long-term survival in patients surgically treated for colorectal cancer .
-
-###24477032
-BACKGROUND	Applying appropriate positive end-expiratory pressure ( PEEP ) to corresponding intra-abdominal pressure ( IAP ) can improve gas exchange during capnoperitoneum without any hemodynamic effects .
-METHODS	A total of 75 patients were randomly allocated to group 0PEEP ( n = 25 ) , group 5PEEP ( n = 25 ) , and group 10PEEP ( n = 25 ) according to the level of PEEP , in whom capnoperitoneum was created with IAP of 14 , 8 , and 14 mm Hg , respectively .
-METHODS	Hemodynamic and respiratory parameters were recorded up to 30 minutes after capnoperitoneum .
-RESULTS	In 0PEEP group , mean end-tidal carbon dioxide demonstrated significant rise 2 minutes after capnoperitoneum and plateaued at about 15 minutes but remained at high level for up to 30 minutes when compared with the 5PEEP and 10PEEP groups ( P < 0.05 ) .
-RESULTS	Correspondingly , the mean PaCO2 ( 48.04.1 mm Hg ) for the 0PEEP group was higher at 30 minutes when compared with 5PEEP ( 37.82.7 mm Hg ) and 10PEEP ( 37.23.9 mm Hg ) groups .
-RESULTS	The oxygenation was better preserved in 5PEEP and 10PEEP groups with significantly higher PaO2/Fio2 ratio .
-RESULTS	Heart rate , mean arterial pressure , and cardiac output remained stable throughout the study in all the 3 groups .
-CONCLUSIONS	Application of appropriate PEEP corresponding to the IAP helped maintain CO2 elimination and improved oxygenation without any hemodynamic disturbance in patients undergoing laparoscopic cholecystectomy .
-
-###24939433
-OBJECTIVE	Isoflavones are present in soy foods and soy-based supplements .
-OBJECTIVE	Despite low plasma isoflavone concentrations in the general Western population , concentrations in supplement users exceed those suggested to be beneficial for health in Asian populations , raising concerns for adverse effects .
-OBJECTIVE	To aid risk assessment , quantification of the relation between isoflavone intake and plasma concentrations is essential .
-METHODS	Plasma samples were collected from postmenopausal women in three placebo-controlled crossover studies with 8-week periods for supplements ( two studies , ~ 100mg isoflavones/day , n = 88 ) or 4-week periods for soy foods ( one study , ~ 48mg isoflavones/day , n = 15 ) .
-METHODS	Plasma isoflavone concentrations ( daidzein , equol , genistein and glycitein ) were quantified using high-performance liquid chromatography and electrochemical detection .
-METHODS	The association between plasma concentrations and isoflavone intake , equol producer status , intake-producer interaction and background dietary intake was assessed based on the assumption of a log-linear relation .
-RESULTS	Median plasma total isoflavone concentrations after the soy food and supplement interventions were respectively 2.16 and 3.47 mol/l for equol producers and 1.30 and 2.39 mol/l for non-producers .
-RESULTS	Regression analysis showed that doubling isoflavone intake increased plasma concentrations by 55-62 % ( s.e. 1-2 % , R ( 2 ) > 0.87 ) for daidzein , genistein , equol ( only for producers ) and total isoflavones ; for glycitein the association was weaker ( 151 % , R ( 2 ) = 0.48 ) .
-RESULTS	Adjustments for energy , carbohydrate and fat intake did not affect these estimates .
-RESULTS	Inter-individual variation , estimated based on repeated measures in one of the studies , was 30-96 % .
-CONCLUSIONS	Although the relation between isoflavone intake and plasma concentrations was adequately quantified , the use of isoflavone intake data for risk assessment needs caution due to large inter-individual variation in plasma concentrations .
-
-###25907821
-BACKGROUND	The simultaneous presence of cancer and other medical conditions ( comorbidity ) is frequent .
-BACKGROUND	Cigarette smoking is the major risk factor for as well head and neck cancer ( HNC ) and lung cancer ( LC ) as chronic obstructive pulmonary disease ( COPD ) .
-BACKGROUND	COPD is the most common comorbidity in LC patients , and presence of COPD worsens the prognosis of HNC and LC .
-BACKGROUND	COPD is under-diagnosed and under-treated in the Danish population .
-BACKGROUND	The aims of this study were to determine the prevalence of COPD in a HNC and LC population , and to determine the need and feasibility of a randomized controlled phase II trial comparing usual care with optimized medical treatment of COPD in cancer patients .
-METHODS	All patients with HNC or LC referred for oncologic treatment in a university hospital during a 10-month period were invited to attend a pulmonary clinic for evaluation of lung function .
-METHODS	Patients who were found to have concomitant COPD were randomized to intervention or usual care .
-METHODS	Primary endpoints were prevalence of COPD among the referred patients with either LC or HNC , and further whether the patients that were diagnosed with COPD already received treatment in accordance with Danish COPD guidelines .
-METHODS	Secondary outcome was feasibility , i.e. the proportion of eligible patients that accepted follow-up in the pulmonary clinic for 24 weeks in addition to oncological treatment .
-METHODS	The design of the randomized trail is described in detail .
-RESULTS	In total 130 patients of whom 65 % had LC and 35 % HNC have been screened during the first seven months of this ongoing trial .
-RESULTS	Sixty-eight percent of LC patients and 22 % of HNC patients had COPD .
-RESULTS	All but one of 68 eligible patients accepted randomization .
-RESULTS	Nearly one third ( 31 % ) of the LC and HNC patients with COPD were diagnosed prior to study entry , and of these , only 33 % were receiving correct treatment according to current guidelines .
-CONCLUSIONS	For patients with LC , and to a lesser extend HNC , there is a need for improved diagnosis and treatment of concomitant COPD .
-CONCLUSIONS	Furthermore , patients found it acceptable to be scheduled for a 24-week follow-up in a pulmonary clinic along with their oncological treatment .
-
-###25101966
-BACKGROUND	Existing eye-tracking literature has shown that both adults and children with autism spectrum disorders ( ASD ) show fewer and slower fixations on faces .
-BACKGROUND	Despite this reduced saliency and processing of other faces , recognition of their own face is reported to be more `` typical '' in nature .
-BACKGROUND	This study uses eye-tracking to explore the typicality of gaze patterns when children with ASD attend their own faces compared to other familiar and unfamiliar faces .
-METHODS	Eye-tracking methodology was used to explore fixation duration and time taken to fixate on the Eye and Mouth regions of familiar , unfamiliar and Self Faces .
-METHODS	Twenty-one children with ASD ( 9-16 years ) were compared to typically developing matched groups .
-RESULTS	There were no significant differences between children with ASD and typically matched groups for fixation patterns to the Eye and Mouth areas of all face types ( familiar , unfamiliar and self ) .
-RESULTS	Correlational analyses showed that attention to the Eye area of unfamiliar and Self Faces was related to socio-communicative ability in children with ASD .
-CONCLUSIONS	Levels of socio-communicative ability in children with ASD were related to gaze patterns on unfamiliar and Self Faces , but not familiar faces .
-CONCLUSIONS	This lack of relationship between ability and attention to familiar faces may indicate that children across the autism spectrum are able to fixate these faces in a similar way .
-CONCLUSIONS	The implications for these findings are discussed .
-
-###25070547
-OBJECTIVE	To determine if increasing the hormone dose or eliminating the hormone-free interval improves key pharmacokinetic ( PK ) alterations caused by obesity during oral contraceptive ( OC ) use .
-METHODS	Obese [ body mass index ( BMI ) 30 kg/m ( 2 ) ] , ovulatory , otherwise healthy , women received an OC containing 20 mcg ethinyl estradiol ( EE ) / 100 mcg levonorgestrel ( LNG ) dosed cyclically ( 21 days active pills with 7-day placebo week ) for two cycles and then were randomized for two additional cycles to the following : continuous cycling ( CC , a dose neutral arm using the same OC with no hormone-free interval ) or increased dose ( ID , a dose escalation arm using an OC containing 30 mcg EE/150 mcg LNG cyclically ) .
-METHODS	During Cycles 2 , 3 and 4 , outpatient visits were performed to assess maximum serum concentration ( Cmax ) , area under the curve ( AUC0 - ) and time to steady state as well as pharmacodynamics .
-METHODS	These key PK parameters were calculated and compared within groups between baseline and treatment cycles .
-RESULTS	A total of 31 women enrolled and completed the study ( CC group , n = 16 ; ID group , n = 15 ) .
-RESULTS	Demographics were similar between groups [ mean BMI : CC , 38 kg/m ( 2 ) ( S.D. 5.1 ) ; ID , 41 kg/m ( 2 ) ( S.D. 7.6 ) ] .
-RESULTS	At baseline , the key LNG PK parameters were no different between groups ; average time to reach steady state was 12 days in both groups ; Cmax were CC : 3.821.28 ng/mL and ID : 3.130.87 ng/mL ; and AUC0 - were CC : 267115 h ng/mL and ID : 19975 h ng/mL .
-RESULTS	Following randomization , the CC group maintained steady-state serum levels whereas the ID group had a significantly higher Cmax ( p < .001 ) but again required 12 days to achieve steady state .
-RESULTS	However , AUC was not significantly different between CC ( 412255 h ng/mL ) and ID ( 283130 h ng/mL ) .
-RESULTS	Forty-five percent ( 14/31 ) of the study population had evidence of an active follicle-like structure prior to randomization and afterwards this decreased to 9 % ( 3/31 ) .
-CONCLUSIONS	Both increasing the OC dose and continuous dosing appear to counteract the impact of obesity on key OC PK parameters .
-CONCLUSIONS	Obesity adversely affects the pharmacokinetics of very low dose OC pills .
-CONCLUSIONS	Although the impact of these changes on OC efficacy is still under debate , PK parameters can be normalized in obese users by continuous dosing or increasing to a low-dose pill .
-
-###25341431
-BACKGROUND	Postural balance and potentially fall risk increases among older adults living with neurological diseases , especially Parkinson 's disease ( PD ) .
-BACKGROUND	Since conventional therapies such as levodopa or deep brain stimulation may fail to alleviate or may even worsen balance , interest is growing in evaluating alternative PD therapies .
-OBJECTIVE	The purpose of the current study was to assess improvement in postural balance in PD patients following electroacupuncture ( EA ) as an alternative therapy .
-METHODS	15 aging adults ( 71.2 6.3 years ) with idiopathic PD and 44 healthy age-matched participants ( 74.6 6.5 years ) were recruited .
-METHODS	The PD participants were randomly assigned ( at a ratio of 2:1 ) to an intervention ( n = 10 ) or to a control group ( n = 5 ) .
-METHODS	The intervention group received a 30-min EA treatment on a weekly basis for 3 weeks , while the control group received a sham treatment .
-METHODS	Outcomes were assessed at baseline and after the final therapy .
-METHODS	Measurements included balance assessment , specifically the ratio of medial-lateral ( ML ) center-of-gravity ( COG ) sway to anterior-posterior ( AP ) sway ( COGML/AP ) and ankle/hip sway during eyes-open , eyes-closed , and eyes-open dual-task trials , the Unified Parkinson 's Disease Rating Scale ( UPDRS ) , as well as quality of life , concerns for fall , and pain questionnaires .
-RESULTS	No difference was observed for the assessed parameters between the intervention and the control group at baseline .
-RESULTS	After treatment , an improvement in balance performance was observed in the intervention group .
-RESULTS	Compared with the healthy population , PD patients prior to treatment had larger COGML/AP sway with more dependency on upper-body movements for maintaining balance .
-RESULTS	Following EA therapy , COGML/AP sway was reduced by 31 % and ankle/hip sway increased by 46 % in the different conditions ( p = 0.02 for the dual-task condition ) .
-RESULTS	The clinical rating revealed an overall improvement ( p < 0.01 ) in mentation , behavior , and mood ( UPDRS part I , 49 % ) , activities of daily living ( UPDRS part II , 46 % ) , and motor examination ( UPDRS part III , 40 % ) .
-RESULTS	There was a significant reduction ( p < 0.02 ) in the specific items regarding UPDRS fall status ( 67 % ) and rigidity ( 48 % ) .
-RESULTS	Changes were small and nonsignificant in the controls ( p > 0.29 ) .
-CONCLUSIONS	This pilot study demonstrates improvement in rigidity and balance following EA .
-CONCLUSIONS	These preliminary results suggest EA could be a promising alternative treatment for balance disturbance in PD .
-
-###25358095
-BACKGROUND	Smoking reduction remains a pivotal issue in public health policy , but quit rates obtained with traditional quit-smoking therapies remain disappointingly low .
-BACKGROUND	Tobacco Harm Reduction ( THR ) , aiming at less harmful ways of consuming nicotine , may provide a more effective alternative .
-BACKGROUND	One promising candidate for THR are electronic cigarettes ( e-cigs ) .
-BACKGROUND	The aim of this study was to investigate the efficacy of second-generation e-cigs both in terms of acute craving-reduction in the lab and in terms of smoking reduction and experienced benefits/complaints in an eight-month Randomized Controlled Trial ( RCT ) .
-METHODS	RCT with three arms .
-METHODS	Participants ( N = 48 ) unwilling to quit smoking were randomized into two e-cig groups and one control group .
-METHODS	During three lab sessions ( over two months ) participants , who had been abstinent for four hours , vaped/smoked for five minutes , after which we monitored the effect on craving and withdrawal symptoms .
-METHODS	eCO and saliva cotinine levels were also measured .
-METHODS	In between lab sessions , participants in the e-cig groups could use e-cigs or smoke ad libitum , whereas the control group could only smoke .
-METHODS	After the lab sessions , the control group also received an e-cig .
-METHODS	The RCT included several questionnaires , which repeatedly monitored the effect of ad libitum e-cig use on the use of tobacco cigarettes and the experienced benefits/complaints up to six months after the last lab session .
-RESULTS	From the first lab session on , e-cig use after four hours of abstinence resulted in a reduction in cigarette craving which was of the same magnitude as when a cigarette was smoked , while eCO was unaffected .
-RESULTS	After two months , we observed that 34 % of the e-cig groups had stopped smoking tobacco cigarettes , versus 0 % of the control group .
-RESULTS	After five months , the e-cig groups demonstrated a total quit-rate of 37 % , whereas the control group showed a quit rate of 38 % three months after initiating e-cig use .
-RESULTS	At the end of the eight-month study , 19 % of the e-cig groups and 25 % of the control group were totally abstinent from smoking , while an overall reduction of 60 % in the number of cigarettes smoked per day was observed ( compared to intake ) .
-RESULTS	eCO levels decreased , whereas cotinine levels were the same in all groups at each moment of measurement .
-RESULTS	Reported benefits far outweighed the reported complaints .
-CONCLUSIONS	In a series of controlled lab sessions with e-cig nave tobacco smokers , second generation e-cigs were shown to be immediately and highly effective in reducing abstinence induced cigarette craving and withdrawal symptoms , while not resulting in increases in eCO .
-CONCLUSIONS	Remarkable ( > 50 pc ) eight-month reductions in , or complete abstinence from tobacco smoking was achieved with the e-cig in almost half ( 44 % ) of the participants .
-
-###24783961
-BACKGROUND	Improving nutrition and physical activity behaviors associated with childhood obesity are significant national public health goals .
-BACKGROUND	Energy Balance for Kids with Play ( EB4K with Play ) , developed through a partnership between the Academy of Nutrition and Dietetics Foundation and Playworks , is a multi-component school-based intervention designed to address youth 's nutrition and physical activity behaviors .
-BACKGROUND	This article describes the EB4K with Play intervention and evaluation study and presents the baseline data .
-METHODS	The evaluation is a 2-year cluster-randomized design targeting third - to fifth-grade students enrolled in a low-income , urban school district in northern California .
-METHODS	Six schools were recruited to participate .
-METHODS	Four were randomized to the intervention group and two into a control group .
-METHODS	Baseline student-level data pertaining to nutrition , physical activity , fitness , and BMI were collected in the fall of 2011 .
-METHODS	The EB4K with Play program , which includes direct-to-student nutrition and physical activity interventions , a school wellness component , and parent/community partner outreach components , began immediately after baseline data collection .
-RESULTS	An ethnically diverse sample of students ( n = 844 ) was recruited to participate in the study .
-RESULTS	Baseline data showed a higher percent of eligibility for free and reduced-price school lunch and higher rates of obesity/overweight than the California state averages .
-RESULTS	Fitness levels and levels of moderate-to-vigorous physical activity were comparable to state averages .
-CONCLUSIONS	End-point data will be collected after 2 years of the intervention .
-CONCLUSIONS	The findings from this study should help guide future efforts to design effective intervention programs to support the prevention of pediatric obesity .
-
-###25040180
-BACKGROUND	A topical fixed-dose clindamycin phosphate 12 % and benzoyl peroxide 30 % combination gel ( CLNP/BPO 3 % ) is known to be effective and safe in white people with acne .
-OBJECTIVE	To evaluate the efficacy and safety of CLNP/BPO 30 % topically applied once or twice daily vs. CLNP twice daily in Japanese patients with acne .
-METHODS	Eight hundred patients were randomized to receive CLNP/BPO 30 % once daily , CLNP/BPO 30 % twice daily or CLNP twice daily for 12weeks .
-METHODS	Primary endpoints were absolute change in number of total lesions ( TLs ) from baseline to week 12 to demonstrate the superiority of CLNP/BPO 30 % twice daily and noninferiority of CLNP/BPO 30 % once daily vs. CLNP twice daily .
-METHODS	Secondary endpoints were absolute and percentage changes in TLs , inflammatory lesions ( ILs ) , noninflammatory lesions ( non-ILs ) and Investigator 's Static Global Assessment ( ISGA ) score .
-METHODS	Safety assessments included adverse events ( AEs ) , laboratory tests , vital signs and local skin tolerability .
-RESULTS	Change in TL counts from baseline to week 12 for CLNP/BPO 30 % twice daily was superior to CLNP twice daily ( difference -110 ; P < 001 ) ; CLNP/BPO 30 % once daily was not inferior to CLNP twice daily ( difference -103 ; P < 001 ) .
-RESULTS	Absolute and percentage reductions in TL , IL and non-IL counts and ISGA score were greater for CLNP/BPO 30 % once or twice daily than for CLNP twice daily with significant differences seen from early on .
-RESULTS	Most AEs were mild or moderate .
-RESULTS	The incidence of adverse drug reactions was higher for CLNP/BPO 30 % once ( 240 % ) or twice ( 351 % ) daily than for CLNP twice daily ( 90 % ) .
-CONCLUSIONS	Compared with CLNP twice daily , CLNP/BPO 30 % once daily was more effective and CLNP/BPO 30 % twice daily at least as effective , with an early onset of action and an acceptable safety and tolerability profile in Japanese patients .
-
-###25265449
-OBJECTIVE	No effective pharmaceutical agents have yet been identified to treat acute kidney injury after cardiac surgery .
-OBJECTIVE	To determine whether fenoldopam reduces the need for renal replacement therapy in critically ill cardiac surgery patients with acute kidney injury .
-METHODS	Multicenter , randomized , double-blind , placebo-controlled , parallel-group study from March 2008 to April 2013 in 19 cardiovascular intensive care units in Italy .
-METHODS	We randomly assigned 667 patients admitted to intensive care units after cardiac surgery with early acute kidney injury ( 50 % increase of serum creatinine level from baseline or oliguria for 6 hours ) to receive fenoldopam ( 338 patients ) or placebo ( 329 patients ) .
-METHODS	We used a computer-generated permuted block randomization sequence for treatment allocation .
-METHODS	All patients completed their follow-up 30 days after surgery , and data were analyzed according to the intention-to-treat principle .
-METHODS	Continuous infusion of fenoldopam or placebo for up to 4 days with a starting dose of 0.1 g/kg/min ( range , 0.025-0 .3 g/kg/min ) .
-METHODS	The primary end point was the rate of renal replacement therapy .
-METHODS	Secondary end points included mortality ( intensive care unit and 30-day mortality ) and the rate of hypotension during study drug infusion .
-RESULTS	The study was stopped for futility as recommended by the safety committee after a planned interim analysis .
-RESULTS	Sixty-nine of 338 patients ( 20 % ) allocated to the fenoldopam group and 60 of 329 patients ( 18 % ) allocated to the placebo group received renal replacement therapy ( P = .47 ) .
-RESULTS	Mortality at 30 days was 78 of 338 ( 23 % ) in the fenoldopam group and 74 of 329 ( 22 % ) in the placebo group ( P = .86 ) .
-RESULTS	Hypotension occurred in 85 ( 26 % ) patients in the fenoldopam group and in 49 ( 15 % ) patients in the placebo group ( P = .001 ) .
-CONCLUSIONS	Among patients with acute kidney injury after cardiac surgery , fenoldopam infusion , compared with placebo , did not reduce the need for renal replacement therapy or risk of 30-day mortality but was associated with an increased rate of hypotension .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00621790 .
-
-###24886638
-BACKGROUND	Osteoarthritis ( OA ) is a common problem in older women that is associated with pain and disabilities .
-BACKGROUND	Although yoga is recommended as an exercise intervention to manage arthritis , there is limited evidence documenting its effectiveness , with little known about its long term benefits .
-BACKGROUND	This study 's aims were to assess the feasibility and potential efficacy of a Hatha yoga exercise program in managing OA-related symptoms in older women with knee OA .
-METHODS	Eligible participants ( N = 36 ; mean age 72 years ) were randomly assigned to 8-week yoga program involving group and home-based sessions or wait-list control .
-METHODS	The yoga intervention program was developed by a group of yoga experts ( N = 5 ) .
-METHODS	The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) total score that measures knee OA pain , stiffness , and function at 8 weeks .
-METHODS	The secondary outcomes , physical function of the lower extremities , body mass index ( BMI ) , quality of sleep ( QOS ) , and quality of life ( QOL ) , were measured using weight , height , the short physical performance battery ( SPPB ) , the Pittsburgh Sleep Quality Index ( PSQI ) , the Cantril Self-Anchoring Ladder , and the SF12v2 Health Survey .
-METHODS	Data were collected at baseline , 4 weeks and 8 weeks , and 20 weeks .
-RESULTS	The recruitment target was met , with study retention at 95 % .
-RESULTS	Based on ANCOVAs , participants in the treatment group exhibited significantly greater improvement in WOMAC pain ( adjusted means [ SE ] ) ( 8.3 [ .67 ] , 5.8 [ .67 ] ; p = .01 ) , stiffness ( 4.7 [ .28 ] , 3.4 [ .28 ] ; p = .002 ) and SPPB ( repeated chair stands ) ( 2.0 [ .23 ] , 2.8 [ .23 ] ; p = .03 ) at 8 weeks .
-RESULTS	Significant treatment and time effects were seen in WOMAC pain ( 7.0 [ .46 ] , 5.4 [ .54 ] ; p = .03 ) , function ( 24.5 [ 1.8 ] , 19.9 [ 1.6 ] ; p = .01 ) and total scores ( 35.4 [ 2.3 ] , 28.6 [ 2.1 ] ; p = .01 ) from 4 to 20 weeks .
-RESULTS	Sleep disturbance was improved but the PSQI total score declined significantly at 20 weeks .
-RESULTS	Changes in BMI and QOL were not significant .
-RESULTS	No yoga related adverse events were observed .
-CONCLUSIONS	A weekly yoga program with home practice is feasible , acceptable , and safe for older women with knee OA , and shows therapeutic benefits .
-BACKGROUND	ClinicalTrials.gov : NCT01832155 .
-
-###24384959
-OBJECTIVE	To select suitable chemotherapy for cervical cancer patients by ATP-tumor chemosensitivity assay .
-METHODS	Seventy-two hospitalized patients with cervical cancer between July 2007 and October 2009 were enrolled .
-METHODS	The patients were randomly divided into a trial group ( n = 35 ) and a control group ( n = 37 ) .
-METHODS	ATP-TCA was used to detect the sensitivity of 35 samples of cervical cancer in the trial group to 6 combined chemotherapy regimens .
-METHODS	The chemotherapy regimen in the trial group was confirmed by the results of susceptibility testing and that in the control group was confirmed by clinical experience .
-METHODS	One-year recurrence rate and 3 - year survival rate of two groups were compared after 3 year follow-up .
-RESULTS	ATP-TCA was measured in 32 of the 35 patients in the trial group .
-RESULTS	The sensitive patients for paclitaxel + carboplatin , paclitaxel + oxaliplatin , bleomycin + ifosfamide + cisplatin , bleomycin + vincristine + cisplatin , fluorouracil + cisplatin , and gemcitabine + cisplatin were 20 , 18 , 17 , 18 , 17 , and 21 , respectively .
-RESULTS	There was no significant difference in the 1-year recurrence between the two groups ( P > 0.05 ) , while the 3-year survivors in the trial group were more than those in the control group ( P < 0.05 ) .
-CONCLUSIONS	ATP-TCA method is good for patients with cervical cancer because it is sensitive , effective , and individualized .
-
-###25439084
-BACKGROUND	Exercise is a potential treatment for depression .
-BACKGROUND	However , few studies have evaluated the role of adjunct exercise in the treatment of severely major depressed inpatients .
-BACKGROUND	The goal of this study was to evaluate the effects of add-on exercise on the usual treatment of severely depressed inpatients .
-METHODS	Fifty participants were randomized to an exercise ( exercise + usual treatment ) or a control ( usual treatment ) group .
-METHODS	Twenty-five patients were randomly allocated to each group .
-METHODS	The participants in the exercise group performed three sessions per week throughout the hospitalization period , with a goal dose of 16.5 kcal/kg/week plus the usual pharmacological treatment .
-METHODS	Depressive symptoms and the Quality of Life ( QoL ) of the participants were assessed at the baseline , the second week , and discharge .
-RESULTS	A significant group time interaction was found for depressive symptoms and the physical and psychological domains of QoL .
-RESULTS	Differences between groups occurred at the second week and discharge with respect to depressive symptoms and the physical and psychological domains of QoL .
-RESULTS	There was no difference in the remission rate at discharge ( 48 % and 32 % for the exercise and control group , respectively ) .
-RESULTS	An NNT of 6.25 was found .
-RESULTS	No significant baseline characteristics predict remission at discharge .
-CONCLUSIONS	Add-on exercise is an efficacious treatment for severely depressed inpatients , improving their depressive symptoms and QoL .
-CONCLUSIONS	Initial acceptance of exercise remains a challenge .
-
-###25692840
-BACKGROUND	The IMProved Reduction of Outcomes : Vytorin Efficacy International Trial ( IMPROVE-IT ) is evaluating the potential benefit for reduction in major cardiovascular ( CV ) events from the addition of ezetimibe versus placebo to 40 mg/d of simvastatin therapy in patients who present with acute coronary syndromes and have low-density lipoprotein cholesterol ( LDL-C ) 125 mg/dl .
-METHODS	Randomized double blind clinical trial in patients with acute coronary syndrome and low cholesterol level .
-METHODS	The simvastatin monotherapy arms LDL-C target was < 70 mg/dl , the comparison arm was simvastatin + ezetimibe .
-METHODS	Ezetimibe was assumed to further lower LDL-C by 15 mg/dl and produce an estimated ~ 8 % to 9 % treatment effect .
-METHODS	The primary composite end point was CV death , nonfatal myocardial infarction ( MI ) , nonfatal stroke , rehospitalization for unstable angina ( UA ) , and coronary revascularization ( 30 days postrandomization ) .
-METHODS	The targeted number of events was 5,250 .
-RESULTS	18,144 patients were enroled with either ST segment elevation MI ( STEMI , n = 5,192 ) or UA/non-ST segment elevation MI ( UA/NSTEMI , n = 12,952 ) from October 2005 to July 2010 .
-RESULTS	Primary endpoint occured in 2742 patients ( 34.7 % ) treated with simvastatin in monotherapy and in 2572 patients ( 32.7 % ) ( p = 0.016 ) treated with combination .
-RESULTS	Compared to patients with coronary heart disease given the drug simvastatin plus a placebo , those given both simvastatin and the non-statin drug , ezetimibe , had a 6.4 % lower combined risk of subsequent heart attack , stroke , cardiovascular death , rehospitalization for unstable angina and procedures to restore blood flow to the heart .
-RESULTS	Heart attacks alone were reduced by 13 % , and non-fatal stroke by 20 % .
-RESULTS	Deaths from cardiovascular disease were statistically the same in both groups .
-RESULTS	Patients were followed an average of approximately six years , and some as long as 8.5 years .
-RESULTS	Approximately 2 patients out of every 100 patients treated for 7 years avoided a heart attack or stroke [ Number Needed to Treat ( NNT ) = 50/7 years ] .
-CONCLUSIONS	The study has shown a claer benefit from combination treatment with simvastatin and ezetimibe in patients with acute coronary syndrome and low LDL-C .
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-###24705855
-OBJECTIVE	We investigated the feasibility and acceptance of electronic monitoring of symptoms and syndromes in oncological outpatient clinics using a PALM ( handheld computer ) .
-METHODS	The assessment of a combination of symptoms and clinical benefit parameters grouped in four pairs was tested in a pilot phase in advanced cancer patients .
-METHODS	Based on these experiences , the software E-MOSAIC was developed , consisting of patient-reported symptoms and nutritional intake and objective assessments ( weight , weight loss , performance status and medication for pain , fatigue , and cachexia ) .
-METHODS	E-MOSAIC was then tested in four Swiss oncology centers .
-METHODS	In order to compare the methods , patients completed the E-MOSAIC as a paper and a PALM version .
-METHODS	Preferences of version and completion times were collected .
-METHODS	Assessments were compared using Wilcoxon signed-rank tests , and the test-retest reliability was evaluated .
-RESULTS	The pilot phase was completed by 22 patients .
-RESULTS	Most patients and physicians perceived the assessment as useful .
-RESULTS	Sixty-two patients participated in the feasibility study .
-RESULTS	Twelve patients reported problems ( understanding , optical , tactile ) , and five patients could not complete the assessment .
-RESULTS	The median time to complete the PALM-based assessment was 3min .
-RESULTS	Forty-nine percent of patients preferred the PALM , 23 % preferred a paper version , and 28 % of patients had no preference .
-RESULTS	Paper vs. PALM revealed no significant differences in symptoms , but in nutritional intake ( p = 0.013 ) .
-RESULTS	Test-retest ( 1h , n = 20 ) reliability was satisfactory ( r = 073-98 ) .
-CONCLUSIONS	Electronic symptom and clinical benefit monitoring is feasible in oncology outpatient clinics and perceived as useful by patients , oncology nurses , and oncologists .
-CONCLUSIONS	E-MOSAIC is tested in a prospective randomized trial .
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-###24669146
-OBJECTIVE	To perform a comparative evaluation of the efficacy and acceptability of Rose-K and Soper contact lenses in Keratoconus .
-METHODS	Dr. Rajendra Prasad Center for Ophthalmic Sciences , All India Institute of Medical Sciences , New Delhi .
-METHODS	A randomized comparative clinical trial was performed in keratoconic eyes fitted with Rose-K ( Rose-K group ) and Soper ( Soper group ) contact lenses .
-METHODS	Patients data were evaluated for best spectacle corrected visual acuity , best contact lens corrected visual acuity ( BCLCVA ) , corneal topography , glare acuity , contrast sensitivity , tear function tests and specular microscopy .
-METHODS	Patients were also asked to complete a self-reported comfort questionnaire at each visit .
-RESULTS	Sixty eyes were randomized to the Rose-K and Soper groups .
-RESULTS	The two groups were comparable in all the baseline parameters .
-RESULTS	There was a statistically significant improvement in BCLCVA in both groups at 3 months ( P < 0.01 , both groups ) .
-RESULTS	The difference between in BCLCVA in both groups was not statistically significant .
-RESULTS	In both groups , there was a significant improvement in the comfort score at 3 months compared to baseline ( P < 0.05 , both group ) .
-RESULTS	The Rose-K group had statistically significantly better scores at 1 and 3 months compared with the Soper group ( P = 0.006 and P < 0.001 respectively ) .
-RESULTS	Both groups were associated with a significant ( P < 0.01 ) , but comparable improvement in glare acuity at 3 months .
-RESULTS	There was a significant improvement in contrast sensitivity at 3 months in both groups ( P < 0.01 ) ; the Rose-K group was significantly better than the Soper group at 1 and 3 months ( P = 0.001 and 0.002 respectively ) .
-RESULTS	The mean number of trial lenses required for fitting Rose-K lens ( 2.00 0.59 ) was significantly lower than the Soper lens ( 3.43 0.82 ; P < 0.001 ) .
-CONCLUSIONS	Both the contact lens designs provide an equal improvement in visual acuity in patients with Keratoconus .
-CONCLUSIONS	However , Rose-K contact lens provides greater comfort , better quality of vision and requires less chair time compared with the Soper lens and hence may possibly have a greater acceptability .
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-###25854021
-OBJECTIVE	To observe the effect of electroacupuncture ( EA ) combined with ultraviolet therapy on herpes zoster at the acute stage and the impacts on serum interleukin 2 ( IL-2 ) , interleukin 6 ( IL-6 ) and interleukin 10 ( IL-10 ) in the patients .
-METHODS	Thirty-four patients of herpes zoster were randomized into a medicine group and a combined therapy group , 17 cases in each one .
-METHODS	In the medicine group , the intravenous drops with acyclovir injection , muscular injection with cobamamide and the topical with acyclovir ointment were applied .
-METHODS	Additionally , TDP was radiated locally .
-METHODS	In the combined therapy group , on the basis of the treatment as the medicine group , EA and ultraviolet therapy were supplemented .
-METHODS	The duration of treatment was 10 days in the two groups .
-METHODS	Before and after treatment , blister relief , incrustation time and the visible analogue scale ( VAS ) were recorded in the two groups .
-METHODS	The clinical efficacy was assessed in the two groups and the levels of serum IL-2 , IL-6 and IL-10 were determined in the two groups .
-RESULTS	In the combined therapy group , the time of blister relief and incrustation was earlier apparently than that in the medicine group ( both P < 0.05 ) .
-RESULTS	VAS score after treatment were reduced as compared with that before treatment in the two groups ( both P < 0.01 ) , and the reducing amplitude in the combined therapy group was larger than that in the medicine group ( P < 0.01 ) .
-RESULTS	The total effective rate was 94.1 % ( 16/17 ) in the combined therapy group , higher than 76.4 % ( 13/17 ) in the medicine group ( P < 0.05 ) .
-RESULTS	After treatment , IL-2 levels were increased as compared with those before treatment in the two groups ( both P < 0.05 ) , the levels of IL-6 and IL-10 were reduced obviously as compared with those before treatment in the two groups ( all P < 0.01 ) .
-RESULTS	After treatment , the levels of IL-6 , IL-10 were reduced much more apparently in the combined therapy group as compared with those in the medicine group ( both P < 0.05 ) .
-CONCLUSIONS	EA combined with ultraviolet irradiation more rapidly and effectively relief the symptoms of herpes zoster , significantly relief pain , shorten the duration of sickness , improve the body immunity and reduce nerve injury .
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-###25881751
-BACKGROUND	Imatinib mesylate ( IM ) is a selective tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia and gastrointestinal stromal tumors .
-BACKGROUND	A new once-daily 400-mg film-coated tablet of imatinib has been developed by a pharmaceutical company in Korea .
-OBJECTIVE	The present study was designed to assess and compare the PK parameters , bioavailability , and bioequivalence of the new imatinib 400-mg formulation ( test ) versus the conventional 100-mg formulation ( reference ) administered as a single 400-mg dose in healthy adult male volunteers .
-METHODS	This randomized , open-label , single-dose , two-way crossover study was conducted in healthy Korean male volunteers .
-METHODS	Eligible subjects were randomly assigned in a 1 : 1 ratio to receive 400 mg of the test ( one 400-mg tablet ) or reference ( four 100-mg tablets ) formulation , followed by a 2-week washout period and administration of the alternate formulation .
-METHODS	Serial blood samples were collected at 0 ( predose ) , 0.5 , 1 , 1.5 , 2 , 2.5 , 3 , 4 , 6 , 8 , 10 , 12 , 24 , 48 , and 72 hours after administration .
-METHODS	Plasma imatinib concentrations were determined using liquid chromatography coupled with tandem mass spectrometry .
-METHODS	The formulations were to be considered bioequivalent if the 90 % confidence intervals ( CIs ) of the adjusted geometric mean ratios for Cmax , AUC ( 0-t ) , and AUC ( 0 - ) were within the predetermined range of 0.80 - 1.25 .
-RESULTS	In total , 35 subjects completed the study .
-RESULTS	No serious adverse event was reported during the study .
-RESULTS	The 90 % CIs of the adjusted geometric mean ratios of the test formulation to the reference formulation for C ( max ) , AUC ( 0-t ) and AUC ( 0 - ) of imatinib were all within the bioequivalence criteria range of 0.8 - 1.25 .
-CONCLUSIONS	The test formulation of imatinib met the Korean regulatory requirements for bioequivalence .
-CONCLUSIONS	Both imatinib formulations were well-tolerated in all subjects .
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-###25972254
-OBJECTIVE	To assess the safety and effectiveness of the Hydrus Microstent ( Ivantis , Inc , Irvine , CA ) with concurrent cataract surgery ( CS ) for reducing intraocular pressure ( IOP ) in open-angle glaucoma ( OAG ) .
-METHODS	Prospective , multicenter , randomized , single-masked , controlled clinical trial .
-METHODS	One hundred eyes from 100 patients 21 to 80 years of age with OAG and cataract with IOP of 24 mmHg or less with 4 or fewer hypotensive medications and a washed-out diurnal IOP ( DIOP ) of 21 to 36 mmHg .
-METHODS	On the day of surgery , patients were randomized 1:1 to undergo CS with the microstent or CS alone .
-METHODS	Postoperative follow-up was at 1 day , 1 week , and 1 , 3 , 6 , 12 , 18 , and 24 months .
-METHODS	Washout of hypotensive medications was repeated at 12 and 24 months .
-METHODS	Response to treatment was defined as a 20 % or more decrease in washed out DIOP at 12 and 24 months of follow-up compared with baseline .
-METHODS	Mean DIOP at 12 and 24 months , the proportion of subjects requiring medications at follow-up , and the mean number of medications were analyzed .
-METHODS	Safety measures included change in visual acuity , slit-lamp observations , and adverse events .
-RESULTS	The proportion of patients with a 20 % reduction in washed out DIOP was significantly higher in the Hydrus plus CS group at 24 months compared with the CS group ( 80 % vs. 46 % ; P = 0.0008 ) .
-RESULTS	Washed out mean DIOP in the Hydrus plus CS group was significantly lower at 24 months compared with the CS group ( 16.93.3 mmHg vs. 19.24.7 mmHg ; P = 0.0093 ) , and the proportion of patients using no hypotensive medications was significantly higher at 24 months in the Hydrus plus CS group ( 73 % vs. 38 % ; P = 0.0008 ) .
-RESULTS	There were no differences in follow-up visual acuity between groups .
-RESULTS	The only notable device-related adverse event was focal peripheral anterior synechiae ( 1-2 mm in length ) .
-RESULTS	Otherwise , adverse event frequency was similar in the 2 groups .
-CONCLUSIONS	Intraocular pressure was clinically and statistically significantly lower at 2 years in the Hydrus plus CS group compared with the CS alone group , with no differences in safety .
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-###24996984
-OBJECTIVE	To determine whether bronchoalveolar lavage ( BAL ) - directed therapy for infants and young children with cystic fibrosis ( CF ) , rather than standard therapy , was justified on the grounds of a decrease in average costs and whether the use of BAL reduced treatment costs associated with hospital admissions .
-METHODS	Costs were assessed in a randomized controlled trial conducted in Australia and New Zealand on infants diagnosed with CF after newborn screening and assigned to receive either BAL-directed or standard therapy until they reached 5 years of age .
-METHODS	A health care funder perspective was adopted .
-METHODS	Resource use measurement was based on standardized data collection forms administered for patients across all sites .
-METHODS	Unit costs were obtained primarily from government schedules .
-RESULTS	Mean costs per child during the study period were Australian dollars ( AUD ) 92860 in BAL-directed therapy group and AUD90958 in standard therapy group ( mean difference AUD1902 , 95 % CI AUD-27782 to 31586 , P = .90 ) .
-RESULTS	Mean hospital costs per child during the study period were AUD57302 in the BAL-directed therapy group and AUD66590 in the standard therapy group ( mean difference AUD-9288 ; 95 % CI AUD-35252 to 16676 , P = .48 ) .
-CONCLUSIONS	BAL-directed therapy did not result in either lower mean hospital admission costs or mean costs overall compared with managing patients with CF by a standard protocol based upon clinical features and oropharyngeal culture results alone .
-CONCLUSIONS	Following on our previous findings that BAL-directed treatment offers no clinical advantage over standard therapy at age 5 years , flexible bronchoscopy with BAL can not be recommended for the routine management of preschool children with CF on the basis of overall cost savings .
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-###25493129
-BACKGROUND	Recent research has investigated the use of ultrasound ( US ) for confirming endotracheal tube ( ETT ) placement with varying techniques , accuracies , and challenges .
-BACKGROUND	Our objective was to evaluate the accuracy of a novel , simplified , four-step ( 4S ) technique .
-METHODS	We conducted a blinded , randomized trial of the 4S technique utilizing an adult human cadaver model .
-METHODS	ETT placement was randomized to tracheal or esophageal location .
-METHODS	Three US experts and 45 emergency medicine residents ( EMR ) performed a total of 150 scans .
-METHODS	The primary outcome was the overall sensitivity and specificity of both experts and EMRs to detect location of ETT placement .
-METHODS	Secondary outcomes included a priori subgroup comparison of experts and EMRs for thin and obese cadavers , time to detection , and level of operator confidence .
-RESULTS	Experts had a sensitivity of 100 % ( 95 % CI = 72 % to 100 % ) and specificity of 100 % ( 95 % CI = 77 % to 100 % ) on thin , and a sensitivity of 93 % ( 95 % CI = 66 % to 100 % ) and specificity of 100 % ( 95 % CI = 75 % to 100 % ) on obese cadavers .
-RESULTS	EMRs had a sensitivity of 91 % ( 95 % CI = 69 % to 98 % ) and of specificity 96 % ( 95 % CI = 76 % to 100 % ) on thin , and a sensitivity of 100 % ( 95 % CI = 82 % to 100 % ) specificity of 48 % ( 95 % CI = 27 % to 69 % ) on obese cadavers .
-RESULTS	The overall mean time to detection was 17 seconds ( 95 % CI = 13 seconds to 20 seconds , range : 2 to 63 seconds ) for US experts and 29 seconds ( 95 % CI = 25 seconds to 33 seconds ; range : 6 to 120 seconds ) for EMRs .
-RESULTS	There was a statistically significant decrease in the specificity of this technique on obese cadavers when comparing the EMRs and experts , as well as an increased overall time to detection among the EMRs .
-CONCLUSIONS	The simplified 4S technique was accurate and rapid for US experts .
-CONCLUSIONS	Among novices , the 4S technique was accurate in thin , but appears less accurate in obese cadavers .
-CONCLUSIONS	Further studies will determine optimal teaching time and accuracy in emergency department patients .
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-###25771069
-OBJECTIVE	Uncertainty remains about the efficacy of folic acid therapy for the primary prevention of stroke because of limited and inconsistent data .
-OBJECTIVE	To test the primary hypothesis that therapy with enalapril and folic acid is more effective in reducing first stroke than enalapril alone among Chinese adults with hypertension .
-METHODS	The China Stroke Primary Prevention Trial , a randomized , double-blind clinical trial conducted from May 19 , 2008 , to August 24 , 2013 , in 32 communities in Jiangsu and Anhui provinces in China .
-METHODS	A total of 20,702 adults with hypertension without history of stroke or myocardial infarction ( MI ) participated in the study .
-METHODS	Eligible participants , stratified by MTHFR C677T genotypes ( CC , CT , and TT ) , were randomly assigned to receive double-blind daily treatment with a single-pill combination containing enalapril , 10 mg , and folic acid , 0.8 mg ( n = 10,348 ) or a tablet containing enalapril , 10 mg , alone ( n = 10,354 ) .
-METHODS	The primary outcome was first stroke .
-METHODS	Secondary outcomes included first ischemic stroke ; first hemorrhagic stroke ; MI ; a composite of cardiovascular events consisting of cardiovascular death , MI , and stroke ; and all-cause death .
-RESULTS	During a median treatment duration of 4.5 years , compared with the enalapril alone group , the enalapril-folic acid group had a significant risk reduction in first stroke ( 2.7 % of participants in the enalapril-folic acid group vs 3.4 % in the enalapril alone group ; hazard ratio [ HR ] , 0.79 ; 95 % CI , 0.68-0 .93 ) , first ischemic stroke ( 2.2 % with enalapril-folic acid vs 2.8 % with enalapril alone ; HR , 0.76 ; 95 % CI , 0.64-0 .91 ) , and composite cardiovascular events consisting of cardiovascular death , MI , and stroke ( 3.1 % with enalapril-folic acid vs 3.9 % with enalapril alone ; HR , 0.80 ; 95 % CI , 0.69-0 .92 ) .
-RESULTS	The risks of hemorrhagic stroke ( HR , 0.93 ; 95 % CI , 0.65-1 .34 ) , MI ( HR , 1.04 ; 95 % CI , 0.60-1 .82 ) , and all-cause deaths ( HR , 0.94 ; 95 % CI , 0.81-1 .10 ) did not differ significantly between the 2 treatment groups .
-RESULTS	There were no significant differences between the 2 treatment groups in the frequencies of adverse events .
-CONCLUSIONS	Among adults with hypertension in China without a history of stroke or MI , the combined use of enalapril and folic acid , compared with enalapril alone , significantly reduced the risk of first stroke .
-CONCLUSIONS	These findings are consistent with benefits from folate use among adults with hypertension and low baseline folate levels .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00794885 .
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-###24819432
-OBJECTIVE	To establish whether there was a difference in health-related quality of life ( HRQoL ) in people with chronic musculoskeletal disorders ( PwCMSKD ) after participating in a multimodal physiotherapy program ( MPP ) either two or three sessions a week .
-METHODS	Total of 114 PwCMSKD participated in this prospective randomised controlled trial .
-METHODS	An individualised MPP , consisting of exercises for mobility , motor-control , muscle strengthening , cardiovascular training , and health education , was implemented either twice a week ( G2 : n = 58 ) or three times a week ) ( G3 : n = 56 ) for 1 year .
-RESULTS	HRQoL physical and mental health state ( PHS/MHS ) , Roland Morris disability Questionnaire ( RMQ ) , Neck-Disability-Index ( NDI ) and Western Ontario and McMaster Universities ' Arthritis Index ( WOMAC ) were used to measure outcomes of MPP for people with chronic low back pain , chronic neck pain and osteoarthritis , respectively .
-RESULTS	Measures were taken at baseline , 8 weeks ( 8 w ) , 6 months ( 6m ) , and 1 year ( 1y ) after starting the programme .
-RESULTS	No statistically significant differences were found between the two groups ( G2 and G3 ) , except in NDI at 8 w ( -3.34 , ( CI 95 % : -6.94 / 0.84 , p = 0.025 ( scale 0-50 ) ) .
-RESULTS	All variables showed improvement reaching the following values ( from baseline to 1y ) G2 : PHS : 57.72 ( baseline : 41.17 ; ( improvement : 16.55 % ) , MHS : 74.51 ( baseline : 47.46 , 27.05 % ) , HRQoL 0.90 ( baseline : 0.72 , 18 % ) ) , HRQoL-VAS 84.29 ( baseline : 58.04 , 26.25 % ) , RMQ 4.15 ( baseline : 7.85 , 15.42 % ) , NDI 3.96 ( baseline : 21.87 , 35.82 % ) , WOMAC 7.17 ( baseline : 25.51 , 19.10 % ) .
-RESULTS	G3 : PHS : 58.64 ( baseline : 39.75 , 18.89 % ) , MHS : 75.50 ( baseline : 45.45 , ( 30.05 % ) , HRQoL 0.67 ( baseline : 0.88 , 21 % ) , HRQoL-VAS 86.91 ( baseline : 52.64 , 34.27 % ) , RMQ 4.83 ( baseline : 8.93 , 17.08 % ) , NDI 4.91 ( baseline : 23.82 , 37.82 % ) , WOMAC 6.35 ( baseline : 15.30 , 9.32 % ) .
-CONCLUSIONS	No significant differences between the two groups were found in the outcomes of a MPP except in the NDI at 8 weeks , but both groups improved in all variables during the course of 1 year under study .
-CONCLUSIONS	Implications for Rehabilitation A multimodal physiotherapy program ( MPP ) improves quality of life , overall health , and function in people with chronic musculoskeletal disease after an intervention of short , medium and long term .
-CONCLUSIONS	This implies that twice a week MPP for people with chronic musculoskeletal pain has comparable results to three times a week provision and therefore may have implications in saving resources and cost for patients and service providers without compromising the outcomes of treatment .
-CONCLUSIONS	These results can be considered not only for therapists , but also for managers who offer the services to optimise the balance cost-effectiveness of the proposed interventions .
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-###24232362
-OBJECTIVE	The beneficial role of exercise as a treatment approach in Huntington 's disease ( HD ) has support from both preclinical work and small-scale studies ; however , there have been no controlled studies of gym-based exercise in people with HD .
-OBJECTIVE	This phase 2 randomized trial ( ISRCTN 59910670 ) assessed feasibility , safety , acceptability , and benefit of a structured exercise program .
-METHODS	Thirty-one participants ( 16 men ; mean [ SD ] age = 50.4 [ 11.4 ] years ) were randomly allocated to intervention ( n = 16 ) or control group ( usual care ; n = 15 ) .
-METHODS	The intervention entailed a weekly supervised gym session of stationary cycling and resistance exercises , and a twice weekly independent home-based walking program .
-METHODS	Retention and adherence rates and adverse events were recorded .
-METHODS	Acceptability was determined from subjective reports of tolerability and physiological measures recorded during the gym sessions .
-METHODS	Assessment of benefit included measures of physical abilities , disease severity , and quality of life ( 36-Item Short Form Health Survey ) .
-METHODS	Analysis of covariance was used to test outcomes of interest .
-RESULTS	The retention rate was 81 % ( 9 of the 11 individuals who started the intervention completed it ) and of the 9 who completed the program , 7 attended more than 75 % ( 9/12 ) of the gym sessions .
-RESULTS	There were no related adverse events and the intervention was well tolerated by most participants .
-RESULTS	The between-group effect estimate for the Mental Component Summary score of the 36-Item Short Form Health Survey ( n = 9 ; intervention , n = 13 ; control ) was 7 ( 95 % CI : 0.4-13 .7 ) Moderate effect sizes for cognitive outcomes and measures of walking were also observed .
-CONCLUSIONS	Observed effect sizes for clinical outcomes suggest the structured exercise program has benefit for persons with HD ; larger scale trials are warranted.Video Abstract available ( see Video , Supplemental Digital Content 1 , http://links.lww.com/JNPT/A60 ) for more insights from the authors .
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-###25116938
-BACKGROUND	To optimize positive outcomes , the design of new pharmacy services should consider the preferences of consumers with chronic condition ( s ) and their carers .
-OBJECTIVE	( i ) To evaluate the relative importance of community pharmacy service characteristics , from the perspective of consumers with chronic condition ( s ) and carers ; ( ii ) To compare consumer and carer preferences to health professional beliefs about ideal service characteristics for consumers .
-METHODS	A discrete choice experiment was completed by consumers with chronic condition ( s ) and/or carers ( n = 602 ) and health professionals ( n = 297 ) , recruited from four regions in Australia .
-METHODS	Participants were each randomized to one survey version containing four ( from a total 72 ) different choices between two new pharmacy services .
-METHODS	Consumer and carer participants were also given an ` opt out ' alternative of current service .
-METHODS	Each service was described using six attributes related to pharmacy service characteristics : continued medicines supply , continuity and coordinated care , location , medication management , education and information , and cost .
-RESULTS	Consumers and carers placed highest priority on continued medicines supply by a pharmacist for regular and symptom flare up medicines ( 100 priority points ) , a pharmacy located within a ` one-stop ' health center ( 61 points ) and home delivery of medicines ( 52 points ) .
-RESULTS	Although continuedmedicines supply was most important for consumers and carers , pharmacy location was perceivedby health professionals to be the most important characteristic for consumers .
-RESULTS	Participants were less inclined to choose new services if their current pharmacy offered high quality services thatwere person-centered , easy to access and responsive to their needs .
-RESULTS	Younger , more highly educated and employed participants , and those with established condition ( s ) were more likely to choose new services .
-CONCLUSIONS	Person-centered care is a fundamental tenet for pharmacy services .
-CONCLUSIONS	The provision of continued medicines supply ( e.g. through pharmacist prescribing ) , convenient and coordinated care delivered through a one stop health centre , and home delivery of medicines , should be prioritized when planning pharmacy services to best assist consumers to manage chronic conditions .
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-###24360924
-OBJECTIVE	Farm youth continue to experience high rates of injury and deaths as a result of agricultural activities .
-OBJECTIVE	Farm machinery , especially tractors , is the most common cause of casualties to youth .
-OBJECTIVE	A Roll-Over Protection Structure ( ROPS ) along with a fastened seatbelt can prevent almost all injuries and fatalities from tractor overturns .
-OBJECTIVE	Despite this knowledge , the use of seatbelts by farmers on ROPS tractors remains low .
-OBJECTIVE	This study treats farm safety as a family issue and builds on the central role of parents as teachers and role models of farm safety for youth .
-METHODS	This research study used a longitudinal , repeated-measures , randomized-control design in which youth 10-19years of age were randomly assigned to either of two intervention groups ( parent-led group and staff-led group ) or the control group .
-RESULTS	Fathers in the parent-led group were less likely to operate ROPS tractors without a seatbelt compared with other groups .
-RESULTS	They were more likely to have communicated with youth about the importance of wearing seatbelts on ROPS tractors .
-RESULTS	Consequently , youth in the parent-led group were less likely to operate a ROPS tractor without a seatbelt than the control group at post-test .
-CONCLUSIONS	This randomized control trial supports the effectiveness of a home-based , father-led farm safety intervention as a promising strategy for reducing youth as well as father-unsafe behaviors ( related to tractor seatbelts ) on the farm .
-CONCLUSIONS	This intervention appealed to fathers ' strong motivation to practice tractor safety for the sake of their youth .
-CONCLUSIONS	Involving fathers helped change both father as well as youth unsafe tractor-seatbelt behaviors .
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-###24255597
-BACKGROUND	Several studies have confirmed dramatic changes in skin surface parameters during the winter months .
-BACKGROUND	Although there are many studies supporting the positive effects of topical treatment , there are no published studies demonstrating the effects of oral supplementation in the prevention of negative skin changes during winter .
-BACKGROUND	The purpose of this study was to evaluate the efficacy of an oral micronutrient supplement in preventing the negative effects of winter weather on skin quality using noninvasive biometrologic instruments .
-METHODS	This study included 80 healthy female volunteers aged 35-55 years with phototype II-IV skin .
-METHODS	Randomization was balanced .
-METHODS	Two tablets of a micronutrient supplement ( Perfectil Platinum ) or placebo were administered once daily for 4 months .
-METHODS	The volunteers were examined at baseline , after 4 months , and 6 weeks after termination of treatment ( month 5.5 ) .
-METHODS	The evaluation included skin microrelief by Visioscan as the main outcome , and the secondary outcomes were results on standard macrophotography , skin tension by Reviscometer , skin high-frequency ultrasound , and self-assessment .
-RESULTS	For all pseudoroughness and microrelief indicators , there was a significant increase from baseline to month 4 in the placebo group ( P < 0.05 ) but no change in the active group .
-RESULTS	Descriptive statistics for the mean minimum , mean maximum , and minimum to maximum ratio on the nonexposed study zone showed a significant and dramatic difference between baseline and month 4 and between baseline and month 5.5 ( P < 0.05 ) in the active group , indicating decreasing anisotropy of the skin .
-RESULTS	High-frequency ultrasound on the exposed study zone revealed that skin thickness was significantly decreased in the placebo group during winter but was stable in the treated group ( P < 0.01 ) .
-RESULTS	The photography scaling and self-assessment questionnaire revealed no significant changes in either group .
-CONCLUSIONS	These results indicate that the skin is prone to seasonal changes during winter , particularly in exposed areas .
-CONCLUSIONS	The data also indicate that oral supplementation can be a safe treatment , with no serious side effects , and may prevent or even eliminate the negative effects of winter on the skin .
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-###25576320
-OBJECTIVE	To compare the effectiveness of in vitro fertilisation with single embryo transfer or in vitro fertilisation in a modified natural cycle with that of intrauterine insemination with controlled ovarian hyperstimulation in terms of a healthy child .
-METHODS	Multicentre , open label , three arm , parallel group , randomised controlled non-inferiority trial .
-METHODS	17 centres in the Netherlands .
-METHODS	Couples seeking fertility treatment after at least 12 months of unprotected intercourse , with the female partner aged between 18 and 38 years , an unfavourable prognosis for natural conception , and a diagnosis of unexplained or mild male subfertility .
-METHODS	Three cycles of in vitro fertilisation with single embryo transfer ( plus subsequent cryocycles ) , six cycles of in vitro fertilisation in a modified natural cycle , or six cycles of intrauterine insemination with ovarian hyperstimulation within 12 months after randomisation .
-METHODS	The primary outcome was birth of a healthy child resulting from a singleton pregnancy conceived within 12 months after randomisation .
-METHODS	Secondary outcomes were live birth , clinical pregnancy , ongoing pregnancy , multiple pregnancy , time to pregnancy , complications of pregnancy , and neonatal morbidity and mortality
-RESULTS	602 couples were randomly assigned between January 2009 and February 2012 ; 201 were allocated to in vitro fertilisation with single embryo transfer , 194 to in vitro fertilisation in a modified natural cycle , and 207 to intrauterine insemination with controlled ovarian hyperstimulation .
-RESULTS	Birth of a healthy child occurred in 104 ( 52 % ) couples in the in vitro fertilisation with single embryo transfer group , 83 ( 43 % ) in the in vitro fertilisation in a modified natural cycle group , and 97 ( 47 % ) in the intrauterine insemination with controlled ovarian hyperstimulation group .
-RESULTS	This corresponds to a risk , relative to intrauterine insemination with ovarian hyperstimulation , of 1.10 ( 95 % confidence interval 0.91 to 1.34 ) for in vitro fertilisation with single embryo transfer and 0.91 ( 0.73 to 1.14 ) for in vitro fertilisation in a modified natural cycle .
-RESULTS	These 95 % confidence intervals do not extend below the predefined threshold of 0.69 for inferiority .
-RESULTS	Multiple pregnancy rates per ongoing pregnancy were 6 % ( 7/121 ) after in vitro fertilisation with single embryo transfer , 5 % ( 5/102 ) after in vitro fertilisation in a modified natural cycle , and 7 % ( 8/119 ) after intrauterine insemination with ovarian hyperstimulation ( one sided P = 0.52 for in vitro fertilisation with single embryo transfer compared with intrauterine insemination with ovarian hyperstimulation ; one sided P = 0.33 for in vitro fertilisation in a modified natural cycle compared with intrauterine insemination with controlled ovarian hyperstimulation ) .
-CONCLUSIONS	In vitro fertilisation with single embryo transfer and in vitro fertilisation in a modified natural cycle were non-inferior to intrauterine insemination with controlled ovarian hyperstimulation in terms of the birth of a healthy child and showed comparable , low multiple pregnancy rates.Trial registration Current Controlled Trials ISRCTN52843371 ; Nederlands Trial Register NTR939 .
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-###25415157
-OBJECTIVE	The comparative risks and benefits of early compared with delayed cord clamping in the preterm neonate remain unclear .
-OBJECTIVE	Our objective was to evaluate the short-term effects of delayed clamping of the umbilical cord in preterm neonates .
-METHODS	We conducted a randomized controlled trial comparing immediate with delayed cord clamping among preterm neonates born between 24 and 34 weeks of gestation .
-METHODS	The primary study outcome was the need for blood transfusion .
-METHODS	To detect a 33 % reduction in this outcome ( from 65 to 43.5 % ) with a two-tailed of 0.5 and of 0.8 required 178 patients equally divided into two groups .
-RESULTS	A total of 200 women were randomized , 99 to the delayed and 101 to the immediate clamp group .
-RESULTS	The groups were similar with respect to baseline characteristics .
-RESULTS	The mean gestational age at delivery was 30.83.1 weeks in the delayed compared with 30.72.8 weeks in the immediate clamp group ( P = .64 ) .
-RESULTS	There was no statistically significant difference between groups with regard to the need for blood transfusion : 25 of 99 ( 25.3 % ) in the delayed cord clamp group received one or more blood transfusion compared with 24 of 101 ( 23.7 % ) in the immediate clamp group ( P = .8 ) .
-RESULTS	The rates of various neonatal outcomes including respiratory distress syndrome , periventricular leukomalacia , necrotizing enterocolitis , anemia of prematurity , and neonatal morality did not differ significantly between the groups .
-RESULTS	However , the mean initial hemoglobin ( 17.42.5 compared with 16.32.3 g/dL , P = .001 ) and hematocrit ( 51.37.3 compared with 47.47.3 , P = .001 ) was significantly higher in the delayed group .
-RESULTS	In the delayed clamp group , 11.1 % ( 11/99 ) of neonates had intraventricular hemorrhage compared with 19.8 % ( 20/101 ) in the immediate clamp group ( P = .09 ) .
-CONCLUSIONS	Delayed cord clamping for 30 seconds did not decrease the need for blood transfusion among preterm neonates .
-BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT00579839 .
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-###25037201
-BACKGROUND	Acute hamstring re-injuries are common and hard to predict .
-BACKGROUND	The aim of this study was to investigate the association between clinical and imaging findings and the occurrence of hamstring re-injuries .
-METHODS	We obtained baseline data ( clinical and MRI findings ) of athletes who sustained an acute hamstring injury within 5days of initial injury .
-METHODS	We also collected data of standardised clinical tests within 7days after return to play ( RTP ) .
-METHODS	The number of re-injuries was recorded within 12months .
-METHODS	We analysed the association between the possible predictive variables and re-injuries with a multivariate Cox proportional-hazards regression model .
-RESULTS	Eighty patients were included at baseline and 64 patients could be included in the final analysis because data after RTP were not available in 16 cases .
-RESULTS	There were 17 re-injuries ( 27 % ) .
-RESULTS	None of the baseline MRI findings were univariately associated with re-injury .
-RESULTS	A higher number of previous hamstring injuries ( adjusted OR ( AOR ) 1.33 ; 95 % CI 1.11 to 1.61 ) , more degrees of active knee extension deficit after RTP ( AOR 1.13 ; 95 % CI 1.03 to 1.25 ) , isometric knee flexion force deficit at 15 after RTP ( AOR 1.04 ; 95 % CI 1.01 to 1.07 ) and presence of localised discomfort on hamstring palpation after RTP ( AOR 3.95 ; 95 % CI 1.38 to 11.37 ) were significant independent predictors of re-injury .
-RESULTS	Athletes with localised discomfort on hamstring palpation just after RTP were consequently almost four times more likely to sustain a re-injury .
-CONCLUSIONS	The number of previous hamstring injuries , active knee extension deficit , isometric knee flexion force deficit at 15 and presence of localised discomfort on palpation just after RTP are associated with a higher hamstring re-injury rate .
-CONCLUSIONS	None of the baseline MRI parameters was a predictor of hamstring re-injury .
-BACKGROUND	ClinicalTrial.gov number NCT01812564 .
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-###25851766
-OBJECTIVE	Intra-arterial treatment ( IAT ) in patients with acute ischemic stroke ( AIS ) can be performed with or without general anesthesia ( GA ) .
-OBJECTIVE	Previous studies suggested that IAT without the use of GA ( non-GA ) is associated with better clinical outcome .
-OBJECTIVE	Nevertheless , no consensus exists about the anesthetic management during IAT of AIS patients .
-OBJECTIVE	This study investigates the association between type of anesthesia and clinical outcome in a large cohort of patients with AIS treated with IAT .
-METHODS	All consecutive patients with AIS of the anterior circulation who received IAT between 2002 and 2013 in 16 Dutch hospitals were included in the study .
-METHODS	Primary outcome was functional outcome on the modified Rankin Scale at discharge .
-METHODS	Difference in primary outcome between GA and non-GA was estimated using multiple ordinal regression analysis , adjusting for age , stroke severity , occlusion of the internal carotid artery terminus , previous stroke , atrial fibrillation , and diabetes mellitus .
-RESULTS	Three hundred forty-eight patients were included in the analysis ; 70 patients received GA and 278 patients did not receive GA. .
-RESULTS	Non-GA was significantly associated with good clinical outcome ( odds ratio 2.1 , 95 % confidence interval 1.02-4 .31 ) .
-RESULTS	After adjusting for prespecified prognostic factors , the point estimate remained similar ; statistical significance , however , was lost ( odds ratio 1.9 , 95 % confidence interval 0.89-4 .24 ) .
-CONCLUSIONS	Our study suggests that patients with AIS of the anterior circulation undergoing IAT without GA have a higher probability of good clinical outcome compared with patients treated with general anesthesia .
-
-###24613691
-OBJECTIVE	Restenosis is a limitation of endovascular interventions performed in the superficial femoral artery ( SFA ) .
-OBJECTIVE	Preclinical studies have demonstrated that the perivascular delivery of tissue-engineered allogeneic aortic endothelial cells ( PVS-10200 ) reduced stenosis in porcine models of SFA revascularization .
-OBJECTIVE	The purpose of this study was to investigate the safety and feasibility of percutaneous PVS-10200 delivery after angioplasty and stenting in the SFA of patients with peripheral artery disease .
-METHODS	In this phase I open-label trial , 21 patients ( average lesion length of 10.10 2.36 cm and 70 % stenosis ) were treated with PVS-10200 : 11 in a low-dose cohort ( cohort A ) and 10 in a high-dose cohort ( cohort B ) .
-METHODS	The primary objective was to demonstrate the safety ( incidence of major adverse events ) of PVS-10200 within 4 weeks after surgery .
-METHODS	Secondary end points included assessments of resting ankle-brachial index ( ABI ) in the treated leg , Fontaine class , and time to target lesion revascularization ( TLR ) .
-RESULTS	No patient had a major adverse event within 4 weeks .
-RESULTS	One patient required a limb amputation at 30 weeks .
-RESULTS	At 48 weeks , cohort A and cohort B patients maintained a 37 % and 62 % increase in ABI compared with baseline , respectively ; 70 % of cohort A and 78 % of cohort B improved by 1 Fontaine classification stage , and the TLR rate was 39 % for cohort A and 20 % for cohort B.
-CONCLUSIONS	Percutaneous local delivery of PVS-10200 is a well-tolerated and novel therapeutic approach that may be a suitable treatment for patients after endovascular intervention of the SFA .
-CONCLUSIONS	Larger randomized trials are needed to determine if PVS-10200 can improve ABI and reduce TLR rates .
-
-###26027613
-BACKGROUND	Prior studies have demonstrated a significant gap between guideline-based recommendations and clinical practice in the management of acute ischemic stroke ( AIS ) in China .
-OBJECTIVE	This study implements a targeted multifaceted quality improvement intervention in AIS patients and identifies the feasibility and efficacy of this intervention .
-METHODS	This is a multicenter , 2-arm , open-label , cluster-randomized trial involving 40 clusters ( hospitals ) from China National Network of Stroke Research .
-METHODS	Hospitals are randomized to receive a targeted multifaceted quality improvement intervention ( experimental group ) or routine standard of care ( control group ) .
-METHODS	The multifaceted intervention includes an evidence-based clinical pathway , written care protocols , a quality coordinator , and a monitoring and feedback system of performance measures .
-METHODS	The number of enrolled patients in the trial will be 4,800 .
-METHODS	Primary outcome is the measure of the adherence to AIS evidence-based performance measures including the composite measure ( defined as the total number of interventions performed among eligible patients divided by the total number of possible interventions among eligible patients ) and the all-or-none measure ( defined as the proportion of eligible patients who receive all of the performance measure interventions for which they are eligible ) .
-METHODS	Secondary patient outcomes include inhospital death ; a new vascular event ; disability ; and all-cause death at 3 , 6 , and 12 months after initial symptom onset .
-METHODS	All analyses will be performed according to the intention-to-treatment principle and accounted for clustering using generalized estimating equations .
-CONCLUSIONS	If proven effective , this targeted multifaceted intervention model will be extended nationwide as a model to bridge the evidence-based gap in the AIS management in China .
-
-###24906040
-OBJECTIVE	Administration of secretin improves noninvasive imaging of the pancreatic duct with magnetic resonance cholangiopancreatography ( MRCP ) .
-OBJECTIVE	We performed a large prospective study to investigate whether synthetic human secretin ( RG1068 ) - stimulated MRCP detects pancreatic duct abnormalities with higher levels of sensitivity than MRCP .
-METHODS	We performed a phase 3 , multicenter , baseline-controlled study of patients with acute or acute recurrent pancreatitis who were scheduled to undergo endoscopic retrograde cholangiopancreatography ( ERCP ) between March 26 , 2008 , and October 28 , 2009 .
-METHODS	Patients underwent a baseline MRCP that was immediately followed by administration of RG1068 and repeat MRCP and then underwent ERCP within 30 days ; they were followed up for 30 days .
-METHODS	MRCP and ERCP images were read centrally by 3 radiologists and 2 endoscopists , respectively , who were all independent and blinded ; pancreatic duct abnormalities were evaluated .
-METHODS	The accuracy of MRCP was evaluated using ERCP as the standard .
-RESULTS	In total , 258 patients were enrolled in the study ; 251 MRCP image sets were assessed , and 236 patients had evaluable ERCPs .
-RESULTS	Pancreatic duct abnormalities were observed in 60.2 % of ERCP images .
-RESULTS	All radiologists identified duct abnormalities in RG1068-cin MRCP image sets with significantly higher levels of sensitivity ( P < .0001 ) than in images from MRCP , with minimal loss of specificity .
-RESULTS	Adverse events were reported in 38.0 % of patients after MRCP and 68.1 % after ERCP .
-RESULTS	Of the 55 patients who experienced a serious adverse event , 3 ( 1.2 % ) and 52 ( 20.5 % ) of the events were reported to be temporally associated with MRCP and ERCP , respectively .
-RESULTS	The adverse events most frequently considered related to RG1068 were nausea , abdominal pain , and flushing ; most were mild .
-CONCLUSIONS	Compared with images from MRCP , those from RG1068-stimulated MRCP are improved in many aspects and could aid in diagnosis and clinical decision making for patients with acute , acute recurrent , or chronic pancreatitis .
-CONCLUSIONS	RG1068-enhanced MRCP might also better identify patients in need of therapeutic ERCP ( ClinicalTrials.gov , Number : NCT00660335 ) .
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-###24383441
-BACKGROUND	Stress , depression , and anxiety affect 15 % to 25 % of pregnant women .
-BACKGROUND	However , substantial barriers to psychosocial assessment exist , resulting in less than 20 % of prenatal care providers assessing and treating mental health problems .
-BACKGROUND	Moreover , pregnant women are often reluctant to disclose their mental health concerns to a healthcare provider .
-BACKGROUND	Identifying screening and assessment tools and procedures that are acceptable to both women and service providers , cost-effective , and clinically useful is needed .
-METHODS	The primary objective of this randomized , parallel-group , superiority trial is to evaluate the feasibility and acceptability of a computer tablet-based prenatal psychosocial assessment ( e-screening ) compared to paper-based screening .
-METHODS	Secondary objectives are to compare the two modes of screening on : ( 1 ) the level of detection of prenatal depression and anxiety symptoms and psychosocial risk ; ( 2 ) the level of disclosure of symptoms ; ( 3 ) the factors associated with feasibility , acceptability , and disclosure ; ( 4 ) the psychometric properties of the e-version of the assessment tools ; and ( 5 ) cost-effectiveness .
-METHODS	A sample of 542 women will be recruited from large , primary care maternity clinics and a high-risk antenatal unit in an urban Canadian city .
-METHODS	Pregnant women are eligible to participate if they : ( 1 ) receive care at one of the recruitment sites ; ( 2 ) are able to speak/read English ; ( 3 ) are willing to be randomized to e-screening ; and ( 4 ) are willing to participate in a follow-up diagnostic interview within 1 week of recruitment .
-METHODS	Allocation is by computer-generated randomization .
-METHODS	Women in the intervention group will complete an online psychosocial assessment on a computer tablet , while those in the control group will complete the same assessment in paper-based form .
-METHODS	All women will complete baseline questionnaires at the time of recruitment and will participate in a diagnostic interview within 1 week of recruitment .
-METHODS	Research assistants conducting diagnostic interviews and physicians will be blinded .
-METHODS	A qualitative descriptive study involving healthcare providers from the recruitment sites and women will provide data on feasibility and acceptability of the intervention .
-METHODS	We hypothesize that mental health e-screening in primary care maternity settings and high-risk antenatal units will be as or more feasible , acceptable , and capable of detecting depression , anxiety , and psychosocial risk compared to paper-based screening .
-BACKGROUND	ClinicalTrials.gov Identifier : NCT01899534 .
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-###24687829
-OBJECTIVE	To determine the effects of bevacizumab on patient-reported outcomes ( PROs ; secondary end point ) in the AURELIA trial .
-METHODS	Patients with platinum-resistant ovarian cancer were randomly assigned to chemotherapy alone ( CT ) or with bevacizumab ( BEV-CT ) .
-METHODS	PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module 28 ( EORTC QLQ-OV28 ) and Functional Assessment of Cancer Therapy-Ovarian Cancer symptom index ( FOSI ) at baseline and every two or three cycles ( 8/9 weeks ) until disease progression .
-METHODS	The primary PRO hypothesis was that more patients receiving BEV-CT than CT would achieve at least a 15 % ( 15-point ) absolute improvement on the QLQ-OV28 abdominal/GI symptom subscale ( items 31-36 ) at week 8/9 .
-METHODS	Patients with missing week 8/9 questionnaires were included as unimproved .
-METHODS	Questionnaires from all assessments until disease progression were analyzed using mixed-model repeated-measures ( MMRM ) analysis .
-METHODS	Sensitivity analyses were used to determine the effects of differing assumptions and methods for missing data .
-RESULTS	Baseline questionnaires were available from 89 % of 361 randomly assigned patients .
-RESULTS	More BEV-CT than CT patients achieved a 15 % improvement in abdominal/GI symptoms at week 8/9 ( primary PRO end point , 21.9 % v 9.3 % ; difference , 12.7 % ; 95 % CI , 4.4 to 20.9 ; P = .002 ) .
-RESULTS	MMRM analysis covering all time points also favored BEV-CT ( difference , 6.4 points ; 95 % CI , 1.3 to 11.6 ; P = .015 ) .
-RESULTS	More BEV-CT than CT patients achieved 15 % improvement in FOSI at week 8/9 ( 12.2 % v 3.1 % ; difference , 9.0 % ; 95 % CI , 2.9 % to 15.2 % ; P = .003 ) .
-RESULTS	Sensitivity analyses gave similar results and conclusions .
-CONCLUSIONS	Bevacizumab increased the proportion of patients achieving a 15 % improvement in patient-reported abdominal/GI symptoms during chemotherapy for platinum-resistant ovarian cancer .
-
-###25281300
-BACKGROUND	Breastfeeding is associated with significant positive health outcomes for mothers and infants .
-BACKGROUND	However , despite recommendations from the World Health Organization , exclusive breastfeeding for six months is uncommon .
-BACKGROUND	Increased breastfeeding support early in the postpartum period may be effective in improving breastfeeding maintenance .
-BACKGROUND	This trial will evaluate two community-based interventions to increase breastfeeding duration in Local Government Areas ( LGAs ) in Victoria , Australia .
-METHODS	A three-arm cluster randomised controlled trial design will be used .
-METHODS	Victorian LGAs with a lower than average rate of any breastfeeding at discharge from hospital and more than 450 births per year that agree to participate will be randomly allocated to one of three trial arms : 1 ) standard care ; 2 ) home-based breastfeeding support ; or 3 ) home-based breastfeeding support plus access to a community-based breastfeeding drop-in centre .
-METHODS	The services provided in LGAs allocated to ` standard care ' are those routinely available to postpartum women .
-METHODS	LGAs allocated to the home-based visiting intervention will provide home-visits to women who are identified as at risk of breastfeeding cessation in the early postnatal period .
-METHODS	These visits will be provided by Maternal and Child Health Nurses who have received training to provide the intervention ( SILC-MCHNs ) .
-METHODS	In areas allocated to receive the second intervention , in addition to home-based breastfeeding support , community breastfeeding drop-in centres will be made available , staffed by a SILC-MCHN .
-METHODS	The interventions will run in LGAs for a nine to twelve month period depending on birth numbers .
-METHODS	The primary outcome is the proportion of infants receiving any breast milk at four months of age .
-METHODS	Breastfeeding outcomes will be obtained from routinely collected Maternal and Child Health centre data and from a new data item collecting infant feeding ` in the last 24 hours ' .
-METHODS	Information will also be obtained directly from women via a postal survey .
-METHODS	A comprehensive process evaluation will be conducted .
-CONCLUSIONS	This study will determine if early home-based breastfeeding support by a health professional for women at risk of stopping breastfeeding , with or without access to a community-based breastfeeding drop-in centre , increases breastfeeding duration in Victorian LGAs with low breastfeeding rates .
-BACKGROUND	Australian New Zealand Clinical Trials Registry : ACTRN12611000898954 .
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-###26093872
-BACKGROUND	Insulin-resistant states , including type 2 diabetes ( T2D ) and prediabetes , are associated with elevated cardiovascular ( CV ) risk .
-BACKGROUND	Aleglitazar is a dual peroxisome proliferator-activated receptor / agonist with favorable insulin-sensitizing and glucose-lowering actions , favorable effects on blood lipids , and an acceptable safety profile in short-time studies .
-BACKGROUND	Therefore , it was hypothesized that aleglitazar would reduce CV morbidity and mortality in patients with T2D mellitus and prediabetes ( defined as glycosylated hemoglobin 5.7 % to < 6.5 % ) with previous CV complications .
-METHODS	ALEPREVENT was a phase III , multicenter , randomized , double-blind , trial comparing aleglitazar 150 g or placebo daily in patients with T2D or prediabetes with established , stable CV disease .
-METHODS	The intended sample size was 19,000 with a primary efficacy measure of major adverse CV events .
-METHODS	However , the trial was halted prematurely after 1,999 patients had been randomized because of futility and an unfavorable benefit risk ratio in another CV outcomes trial evaluating aleglitazar .
-RESULTS	At study termination after 58 38 days of treatment , data had been collected from 1,996 patients ( 1,581 with T2D and 415 with pre-T2D ) .
-RESULTS	Despite the brief duration of treatment , aleglitazar induced favorable changes in glycosylated hemoglobin and blood lipids , similar for participants with T2D or prediabetes .
-RESULTS	However , compared with placebo , aleglitazar increased the incidence of hypoglycemia ( 86 vs 166 ; P < .0001 ) , and muscular events ( 3 vs12 ; P = .012 ) .
-CONCLUSIONS	Even within a short duration of exposure , aleglitazar was associated with excess adverse events , corroborating the findings of a larger and longer trial in T2D .
-CONCLUSIONS	Coupled with the previous failure of several other peroxisome proliferator-activated receptor / activators , this class now holds little promise for CV therapeutics .
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-###24760465
-OBJECTIVE	Monopolar electrosurgery is the gold standard for surgical preparation in thoracoscopic spine procedures .
-OBJECTIVE	However , use of ultrasound scissors could decrease blood loss , accelerate the preparation time and improve patient safety , while minimizing operative costs .
-OBJECTIVE	This trial compares both preparation techniques for ventral thoracoscopic spondylodesis .
-METHODS	The study design is an open , prospective , randomized , and double-blinded two-armed clinical trial performed in two centres .
-METHODS	Forty-one patients with vertebral body fractures from T10 to L2 were included .
-METHODS	Primary endpoint : preparation time .
-METHODS	Secondary endpoints : blood loss , organ injuries , duration of hospitalization .
-RESULTS	Primary and secondary endpoints did not differ significantly between groups ( p level 0.05 ) .
-RESULTS	Increased blood loss ( 150 ml or more ) was eliminated with ultrasound scissors ( p = 0.0014 ) .
-CONCLUSIONS	Primary and secondary endpoints did not differ significantly between the two preparation techniques .
-CONCLUSIONS	The use of either ultrasound scissors or electric scalpel offers safe and effective preparation for thoracoscopic spine surgery .
-
-###24461612
-BACKGROUND	Delirium is frequently diagnosed in critically ill patients and is associated with poor clinical outcomes .
-BACKGROUND	Haloperidol is the most commonly used drug for delirium despite little evidence of its effectiveness .
-BACKGROUND	The aim of this study was to establish whether early treatment with haloperidol would decrease the time that survivors of critical illness spent in delirium or coma .
-METHODS	We did this double-blind , placebo-controlled randomised trial in a general adult intensive care unit ( ICU ) .
-METHODS	Critically ill patients ( 18 years ) needing mechanical ventilation within 72 h of admission were enrolled .
-METHODS	Patients were randomised ( by an independent nurse , in 1:1 ratio , with permuted block size of four and six , using a centralised , secure web-based randomisation service ) to receive haloperidol 2.5 mg or 0.9 % saline placebo intravenously every 8 h , irrespective of coma or delirium status .
-METHODS	Study drug was discontinued on ICU discharge , once delirium-free and coma-free for 2 consecutive days , or after a maximum of 14 days of treatment , whichever came first .
-METHODS	Delirium was assessed using the confusion assessment method for the ICU ( CAM-ICU ) .
-METHODS	The primary outcome was delirium-free and coma-free days , defined as the number of days in the first 14 days after randomisation during which the patient was alive without delirium and not in coma from any cause .
-METHODS	Patients who died within the 14 day study period were recorded as having 0 days free of delirium and coma .
-METHODS	ICU clinical and research staff and patients were masked to treatment throughout the study .
-METHODS	Analyses were by intention to treat .
-METHODS	This trial is registered with the International Standard Randomised Controlled Trial Registry , number ISRCTN83567338 .
-RESULTS	142 patients were randomised , 141 were included in the final analysis ( 71 haloperidol , 70 placebo ) .
-RESULTS	Patients in the haloperidol group spent about the same number of days alive , without delirium , and without coma as did patients in the placebo group ( median 5 days [ IQR 0-10 ] vs 6 days [ 0-11 ] days ; p = 0.53 ) .
-RESULTS	The most common adverse events were oversedation ( 11 patients in the haloperidol group vs six in the placebo group ) and QTc prolongation ( seven patients in the haloperidol group vs six in the placebo group ) .
-RESULTS	No patient had a serious adverse event related to the study drug .
-CONCLUSIONS	These results do not support the hypothesis that haloperidol modifies duration of delirium in critically ill patients .
-CONCLUSIONS	Although haloperidol can be used safely in this population of patients , pending the results of trials in progress , the use of intravenous haloperidol should be reserved for short-term management of acute agitation .
-BACKGROUND	National Institute for Health Research .
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-###25389218
-OBJECTIVE	A recently published study showed the safety and efficacy of LSD-assisted psychotherapy in patients with anxiety associated with life-threatening diseases .
-OBJECTIVE	Participants of this study were included in a prospective follow-up .
-METHODS	12 months after finishing LSD psychotherapy , 10 participants were tested for anxiety ( STAI ) and participated in a semi-structured interview .
-METHODS	A Qualitative Content Analysis ( QCA ) was carried out on the interviews to elaborate about LSD effects and lasting psychological changes .
-RESULTS	None of the participants reported lasting adverse reactions .
-RESULTS	The significant benefits as measured with the STAI were sustained over a 12-month period .
-RESULTS	In the QCA participants consistently reported insightful , cathartic and interpersonal experiences , accompanied by a reduction in anxiety ( 77.8 % ) and a rise in quality of life ( 66.7 % ) .
-RESULTS	Evaluations of subjective experiences suggest facilitated access to emotions , confrontation of previously unknown anxieties , worries , resources and intense emotional peak experiences la Maslow as major psychological working mechanisms .
-RESULTS	The experiences created led to a restructuring of the person 's emotional trust , situational understanding , habits and world view .
-CONCLUSIONS	LSD administered in a medically supervised psychotherapeutic setting can be safe and generate lasting benefits in patients with a life-threatening disease .
-CONCLUSIONS	Explanatory models for the therapeutic effects of LSD warrant further study .
-
-###24837141
-OBJECTIVE	This study aimed to evaluate the effectiveness of a static ground reaction ankle foot orthosis and strapping system on improving gait parameters in children with spastic diplegic cerebral palsy .
-METHODS	The current study was conducted at the physical therapy faculty of Cairo University , Egypt .
-METHODS	This study included 57 children of both sexes , aged 6 to 8 years .
-METHODS	Three-armed randomized control trial .
-METHODS	Participants in all groups received a traditional neuro-developmental physical therapy program that included standing and gait training exercises .
-METHODS	Children in group A performed the training program without any orthotic management , in group B with the TheraTogs strapping system , and in group C with the TheraTogs strapping system and static ground reaction ankle foot orthoses .
-METHODS	Children underwent treatment for two hours daily , except on weekends , for twelve successive weeks .
-METHODS	Gait speed , cadence , stride length , and hip and knee flexion angles in the mid-stance phase were evaluated pre-and post-treatment using a three-dimensional motion analysis system ( pre-reflex system ) .
-RESULTS	Statistically significant differences were recorded among the three groups post-treatment in gait speed , cadences , and stride length .
-RESULTS	The P-values for these variable differences were 0.03 , 0.011 , and 0.001 respectively .
-RESULTS	Significant post-treatment differences were also recorded for bilateral hip-and knee-flexion angles .
-RESULTS	For all measured parameters , better significant results were registered for group C than for the other groups .
-CONCLUSIONS	Orthotic intervention composed of a static ground reaction ankle foot orthosis combined with the TheraTogs strapping system improves gait more than conventional treatment with or without TheraTogs in children with spastic diplegic cerebral palsy .
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-###24727897
-BACKGROUND	To investigate if the cramp threshold frequency ( CTF ) can be altered by electrical muscle stimulation in a shortened position .
-METHODS	A total of 15 healthy male sport students were randomly allocated to an intervention ( IG , n = 10 ) and a non-treatment control group ( CG , n = 5 ) .
-METHODS	Calf muscles of both legs in the IG were stimulated equally twice a week over 6 weeks .
-METHODS	The protocol was 35 s on , 10 s off , 150 s impulse width , 30 Hz above the individual CTF , and was at 85 % of the maximal tolerated stimulation energy .
-METHODS	One leg was stimulated in a shortened position , inducing muscle cramps ( CT ) , while the opposite leg was fixated in a neutral position at the ankle , hindering muscle cramps ( nCT ) .
-METHODS	CTF tests were performed prior to the first and 96 h after the 6 ( th ) ( 3 w ) and 12 ( th ) ( 6 w ) training session .
-RESULTS	After 3 w , the CTF had significantly ( p < 0.001 ) increased in CT calves from 23.35.7 Hz to 33.36.9 Hz , while it remained unchanged in nCT ( pre : 23.65.7 Hz , mid : 22.33.5 Hz ) and in both legs of the CG ( pre : 21.83.2 Hz , mid : 22.02.7 Hz ) .
-RESULTS	Only CT saw further insignificant increases in the CTF .
-RESULTS	The applied stimulation energy ( mA s ) positively correlated with the effect on the CTF ( r = 0.92 ; p < 0.001 ) .
-CONCLUSIONS	The present study may be useful for developing new non-pharmacological strategies to reduce cramp susceptibility .
-BACKGROUND	German Clinical Trials Register DRKS00005312 .
-
-###25238659
-OBJECTIVE	To determine the effects of addition of different dosages of gonadotrophin releasing hormone agonist ( GnRH-a ) to routine luteal phase support ( LPS ) on implantation and pregnancy rates .
-METHODS	Three hundred infertile couples who were treated by intracytoplasmic sperm injection and embryo transfer ( ICSI-ET ) following controlled ovarian stimulation ( COS ) with long luteal GnRH agonist protocol were enrolled .
-METHODS	All women received 600 mg/day vaginal micronized progesterone plus 4 mg 17 estradiol for LPS starting from the day of oocyte retrieval .
-METHODS	Patients ( n = 300 ) were randomized into three treatment groups .
-METHODS	Group A ( n = 100 ) received leuprolide acetate 1 mg s.c. injection 3 days after ET in addition to routine LPS .
-METHODS	Group B ( n = 100 ) received two sequential doses of leuprolide acetate 1 mg s.c. injections 3 and 6 days after ET in addition to routine LPS .
-METHODS	Control group ( n = 100 ) received only the routine LPS .
-RESULTS	A total of 279 patients completed the study .
-RESULTS	The groups were comparable in terms of baseline demographic parameters including age , duration of infertility and day 3 levels of FSH and estradiol .
-RESULTS	The cycle parameters of the groups were also comparable regarding the E2 level on day of hCG , number of retrieved oocytes , number of day 3 embryos , number of embryos transferred , and endometrial thickness on both days of OPU and ET .
-RESULTS	The implantation rates were similar in between the Groups A , B , and control group ( 20.7 % and 25.8 % vs. 13.3 % , respectively ; P = .099 ) .
-RESULTS	The clinical pregnancy rates and miscarriage rates were similar in between the groups .
-RESULTS	The ongoing pregnancy rates were 27.4 % in control group , 36 % in Group A and 42.9 % in Group B ( P = .093 ) .
-RESULTS	The OHSS rates were comparable in between the groups .
-RESULTS	The multiple pregnancy rates were significantly higher in Groups A and B than in control group ( 12 % and 17.9 % vs. 4.2 % , respectively ; P = .014 ) .
-CONCLUSIONS	The implantation , clinical pregnancy and ongoing pregnancy and multiple pregnancy rates seem to be increased with the addition of GnRH-a to routine luteal phase support .
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-###24572452
-OBJECTIVE	Obesity-induced chronic inflammation is a key component of the pathogenesis of insulin resistance .
-OBJECTIVE	Mounting evidence has demonstrated anti-inflammatory characteristics for vitamin D. Although analogues of vitamin D3 have extensively been used in the treatment of various chronic inflammatory diseases , to our knowledge , no such research is conducted in regards with obesity .
-OBJECTIVE	The aim of this double blind clinical trial study is to investigate whether alphacalcidol treatment in obese subjects can affect the cytokine profile and insulin resistance .
-OBJECTIVE	Moreover , we evaluated the pathways of vitamin D receptor ( VDR ) , PPAR and PGC1 gene expressions which may lead to insulin resistance following treatment with either alphacalcidol or placebo .
-METHODS	A total of 94 obese participants ( BMI30 ) were recruited for the current double blind clinical trial study .
-METHODS	Patients were divided into two intervention ( N. = 40 ) and control groups ( N. = 54 ) based on the stratified randomized method .
-METHODS	One-Alpha Capsules 1 microgram : alfacalcidol ( 1 - hydroxyvitamin D3 ) and placebo were given to subjects once a day for 8 weeks .
-METHODS	Analysis of body composition was performed with use of Body Composition Analyzer .
-METHODS	The circulating levels of TNF - , IL-1 , IL-4 , IL-6 , IL-10 , IL-13 , IL-17 , PTH , and 25-Hydroxy Vi-tamin D were measured with the use of EIA method .
-METHODS	The PBMCs were separated from whole blood by Ficoll-hypaque technique .
-METHODS	Total cellular RNA was extracted and the cDNA was synthesized .
-METHODS	The real-time PCR using specific primer pairs for VDR , PGC1 , PPAR , and - actin was performed .
-RESULTS	The FPG , fat percent and PTH levels were decreased and the levels of HDL-cholesterol and 25-hydroxy vitamin D were significantly increased after treatment with Alfacalcidol .
-RESULTS	Regarding to cytokines levels , the levels of IL6 were significantly decreased and IL10 were significantly increased in Alfacalcidol group in comparison with the control group .
-RESULTS	The relative expressions of VDR , PGC1 , and PPAR genes significantly increased in Alfacalcidol group .
-RESULTS	We found also significant positive correlation between circulating 25-OH vitamin D and relative PGC1 gene expression in participants with insulin resistance .
-CONCLUSIONS	It seems that Alfacalcidol treatment may be effective in amelioration of the inflammatory state in obesity .
-CONCLUSIONS	This supplement might also improve resistance to insulin through enhancement of relative VDR and its downstream genes expression , which are demonstrated to be involved in glucose homeostasis pathways .
-
-###24229360
-BACKGROUND	Macrolides reduce exacerbations in patients with COPD .
-BACKGROUND	Their effects on health status has not been assessed as primary outcome and is less clear .
-BACKGROUND	This study assessed the effects of prophylactic azithromycin on cough-specific health status in COPD-patients with chronic productive cough .
-METHODS	In this randomised controlled trial 84 patients met the eligibility criteria : age of 40 years , COPD GOLD stage 2 and chronic productive cough .
-METHODS	The intervention-group ( n = 42 ) received azithromycin 250 mg 3 times a week and the control-group ( n = 42 ) received a placebo .
-METHODS	Primary outcome was cough-specific health status at 12 weeks , measured with the Leicester Cough Questionnaire ( LCQ ) .
-METHODS	Secondary outcomes included generic and COPD-specific health status and exacerbations .
-METHODS	Changes in adverse events and microbiology were monitored .
-RESULTS	Mean age of participants was 6810 years and mean FEV1 was 1.360.47 L.
-RESULTS	The improvement in LCQ total score at 12 weeks was significantly greater with azithromycin ( difference 1.30.5 , 95 % CI 0.3 ; 2.3 , p = 0.01 ) and met the minimal clinically important difference .
-RESULTS	Similar results were found for the domain scores , and COPD-specific and generic health status questionnaires .
-RESULTS	Other secondary endpoints were non-significant .
-RESULTS	No imbalances in adverse events were found .
-CONCLUSIONS	Prophylactic azithromycin improved cough-specific health status in COPD-patients with chronic productive cough to a clinically relevant degree .
-BACKGROUND	ClinicalTrials.gov NCT01071161 .
-
-###25332329
-BACKGROUND	High intake of cow-milk protein in formula-fed infants is associated with higher weight gain and increased adiposity , which have led to recommendations to limit protein intake in later infancy .
-BACKGROUND	The impact of protein from meats for breastfed infants during complementary feeding may be different .
-OBJECTIVE	We examined the effect of protein from meat as complementary foods on growth and metabolic profiles of breastfed infants .
-METHODS	This was a secondary analysis from a trial in which exclusively breastfed infants ( 5-6 mo old from the Denver , CO , metro area ) were randomly assigned to receive commercially available pureed meats ( Meat group ; n = 14 ) or infant cereal ( Cereal group ; n = 28 ) as their primary complementary feedings for 5 mo. .
-METHODS	Anthropometric measures and diet records were collected monthly from 5 to 9 mo of age ; intakes from complementary feeding and breast milk were assessed at 9 mo of age .
-RESULTS	The Meat group had significantly higher protein intake , whereas energy , carbohydrate , and fat intakes from complementary feeding did not differ by group over time .
-RESULTS	At 9 mo of age , mean ( SEM ) intakes of total ( complementary feeding plus breast milk ) protein were 2.9 0.6 and 1.4 0.4 g kg ( -1 ) d ( -1 ) , 17 % and 9 % of daily energy intake , for Meat and Cereal groups , respectively ( P < 0.001 ) .
-RESULTS	From 5 to 9 mo of age , the weight-for-age z score ( WAZ ) and length-for-age z score ( LAZ ) increased in the Meat group ( WAZ : 0.24 0.19 ; LAZ : 0.14 0.12 ) and decreased in the Cereal group ( WAZ : -0.07 0.17 ; LAZ : -0.27 0.24 ) ( P-group by time < 0.05 ) .
-RESULTS	The change in weight-for-length z score did not differ between groups .
-RESULTS	Total protein intake at 9 mo of age and baseline WAZ were important predictors of changes in the WAZ ( R ( 2 ) = 0.23 , P = 0.01 ) .
-CONCLUSIONS	In breastfed infants , higher protein intake from meats was associated with greater linear growth and weight gain but without excessive gain in adiposity , suggesting that potential risks of high protein intake may differ between breastfed and formula-fed infants and by the source of protein .
-
-###25379850
-OBJECTIVE	We aimed to examine the association between total number of resected nodes and survival in patients after esophagectomy with and without nCRT .
-BACKGROUND	Most studies concerning the potentially positive effect of extended lymphadenectomy on survival have been performed in patients who underwent surgery alone .
-BACKGROUND	As nCRT is known to frequently `` sterilize '' regional nodes , it is unclear whether extended lymphadenectomy after nCRT is still useful .
-METHODS	Patients from the randomized CROSS-trial who completed the entire protocol ( ie , surgery alone or chemoradiotherapy + surgery ) were included .
-METHODS	With Cox regression models , we compared the impact of number of resected nodes as well as resected positive nodes on survival in both groups .
-RESULTS	One hundred sixty-one patients underwent surgery alone , and 159 patients received multimodality treatment .
-RESULTS	The median ( interquartile range ) number of resected nodes was 18 ( 12-27 ) and 14 ( 9-21 ) , with 2 ( 1-6 ) and 0 ( 0-1 ) resected positive nodes , respectively .
-RESULTS	Persistent lymph node positivity after nCRT had a greater negative prognostic impact on survival as compared with lymph node positivity after surgery alone .
-RESULTS	The total number of resected nodes was significantly associated with survival for patients in the surgery-alone arm ( hazard ratio per 10 additionally resected nodes , 0.76 ; P = 0.007 ) , but not in the multimodality arm ( hazard ratio 1.00 ; P = 0.98 ) .
-CONCLUSIONS	The number of resected nodes had a prognostic impact on survival in patients after surgery alone , but its therapeutic value is still controversial .
-CONCLUSIONS	After nCRT , the number of resected nodes was not associated with survival .
-CONCLUSIONS	These data question the indication for maximization of lymphadenectomy after nCRT .
-
-###24439644
-OBJECTIVE	To examine the effects of foot reflexology massage on anxiety in patients following CABG surgery .
-METHODS	In this randomized controlled trial , 80 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups after they were matched on age and gender .
-METHODS	On the days following surgery , the experimental group received foot reflexology massage on their left foot 20mina day for 4 days , while the control group was given a gentle foot rub with oil for one minute .
-METHODS	Anxiety was measured using the short-form of the Spielberger State-Trait Anxiety Inventory and the Visual Analogue Scale-Anxiety .
-RESULTS	Both measurement instruments confirmed a significant decrease in anxiety following the foot reflexology massage .
-CONCLUSIONS	The significant decrease in anxiety in the experimental group following the foot reflexology massage supports the use of this complementary therapy technique for the relief of anxiety .
-
-###25773557
-OBJECTIVE	To estimate the effect of sequence on response precision and response behavior in health valuation studies .
-METHODS	Time trade-off ( TTO ) and paired comparison responses from six health valuation studies-four US , one Spanish , and one Dutch-were examined ( 22,225 respondents ) to test whether task sequence influences response precision ( e.g. , rounding ) , response changes , and median response times .
-METHODS	Each study used a computer-based instrument that randomized task sequence among a national sample of adults , age 18 years or older , from the general population .
-RESULTS	For both TTO and paired comparisons , median response times decreased with sequence ( i.e. , learning ) , but tended to flatten after the first three tasks .
-RESULTS	Although the paired comparison evidence demonstrated that sequence had no effect on response precision , the frequency of rounded TTO responses ( to either 1-year or 5-year units ) increased with sequence .
-CONCLUSIONS	Based on these results , randomizing or reducing the number of paired comparison tasks does not appear to influence response precision ; however , generalizability , practicality , and precautionary considerations remain .
-CONCLUSIONS	Overall , participants learned to respond efficiently within the first three tasks and did not resort to satisficing , but may have rounded their TTO responses .
-
-###24704117
-OBJECTIVE	Bulkamid is a new polyacrylamide hydrogel bulking agent for stress urinary incontinence that is injected in the urethral submucosa using a specifically designed device .
-OBJECTIVE	We evaluated the safety and efficacy of Bulkamid vs Contigen collagen gel for stress urinary incontinence or stress predominant mixed urinary incontinence .
-METHODS	This was a single-blind , randomized , prospective , 33-center , 2-arm parallel study of hydrogel vs collagen gel with followup to 1year .
-METHODS	At baseline patients underwent physical examination and bladder testing , and completed quality of life questionnaires and bladder diaries .
-METHODS	After randomization patients could receive up to 3 injections at 1-month intervals .
-METHODS	Patients were assessed 3 , 6 , 9 and 12 months after bulking .
-METHODS	They completed bladder diaries and quality of life questionnaires , and pad weight was tested .
-METHODS	Atthe last visit Valsalva leak point pressure was measured .
-METHODS	Subjective and objective incontinence outcomes and adverse events were compared .
-RESULTS	Of the 345 women 229 were randomized to hydrogel and 116 were randomized to collagen gel .
-RESULTS	At 12 months a 50 % or greater decrease in leakage and incontinence episodes was seen in 53.2 % and 55.4 % of patients who received hydrogel and collagen gel , respectively .
-RESULTS	At 12 months 47.2 % of patients with hydrogel and 50 % with collagen gel reported zero stress incontinence episodes , and 77.1 % and 70 % , respectively , considered themselves cured or improved .
-RESULTS	Major adverse events were rare in each group .
-CONCLUSIONS	Bulkamid is not inferior to Contigen .
-CONCLUSIONS	It has a favorable , persistent effect on stress urinary incontinence with a low risk of serious adverse events .
-CONCLUSIONS	Bulkamid is a new , simple , office based bulking system that shows promise asatreatment in women with stress urinary incontinence , particularly since Contigen is no longer commercially available .
-
-###25300885
-OBJECTIVE	Most problematic alcohol users never seek professional help to reduce their use , and Web-based interventions might fulfill users ' unmet needs for professional support .
-METHODS	This randomized controlled trial compared two open Web-based interventions , one extended self-help program and one brief screening and feedback intervention , with an assessment-only control group .
-METHODS	Participants were 633 Internet help seekers with at least hazardous alcohol use ( Alcohol Use Disorders Identification Test , AUDIT 6 for women and 8 for men ) .
-RESULTS	All groups reduced their alcohol use at 3-month follow-up ( p < 0.001 ) , remaining stable at the 6 - and 12-month follow-ups ( n.s. ) according to AUDIT-C and AUDIT scores ( intention-to-treat , ITT , analysis ) .
-RESULTS	Per protocol ( PP ) analysis , including only participants who accessed the interventions and also reported accessing additional outside interventions during the trial , showed that about 75 % of extended self-help participants moved from probable dependence , harmful or hazardous use to lower alcohol use levels at 3 - and 6 - and 12-month follow-ups , compared to about 40-60 % of brief intervention users and controls who accessed extra help ( p < 0.05 ) .
-CONCLUSIONS	ITT analysis suggested parity over time for all interventions , including assessment only , in reducing problematic alcohol use .
-CONCLUSIONS	In contrast , PP analysis suggested that cognitive-behavioral extended self-help in combination with other interventions was more effective in changing alcohol use than brief intervention or assessment only .
-
-###24796059
-OBJECTIVE	To compare the difference in the efficacy on cervical type of cervical spondylosis ( CS ) between the combined treatment of sword-like needle and chiropractic spinal manipulation ( the combined therapy ) and the simple chiropractic spinal manipulation .
-METHODS	One hundred and thirty-eight cases of cervical type of CS were randomized into a combined therapy group ( 76 cases ) and a simple chiropractic spinal manipulation group ( 62 cases ) .
-METHODS	In the combined therapy group , the sword-like needle therapy was applied at Fengchi ( GB 20 ) , Tianzhu ( BL 10 ) and Jiaji ( EX-B 2 ) C3-C5 .
-METHODS	The chiropractic spinal manipulation was used in combination .
-METHODS	In the chiropractic spinal manipulation group , the simple chiropractic spinal manipulation was adopted .
-METHODS	The treatment was given once every other day in the two groups , 10 days made one session .
-METHODS	One session of treatment was required .
-METHODS	Visual analog scale ( VAS ) score was observed before and after treatment in the two groups and the efficacies were compared between the two groups .
-RESULTS	VAS score after treatment was reduced obviously as compared with that before treatment in the patients of the two groups ( both P < 0.01 ) and VAS score after treatment in the combined therapy group was lower than that in the simple chiropractic spinal manipulation group ( 1.50 + / - 0.58 vs 1.87 + / -1.05 , P < 0.01 ) .
-RESULTS	In the combined therapy group , 48 cases were cured , 20 cases remarkably effective , 8 cases improved and 0 case failed .
-RESULTS	In the chiropractic spinal manipulation group , 30 cases were cured , 16 cases remarkably effective , 15 cases improved and 1 case failed .
-RESULTS	The overall efficacy in the combined therapy group was better than that in the chiropractic spinal manipulation ( P < 0.05 ) .
-CONCLUSIONS	The sword-like needle therapy combined with chiropractic spinal manipulation relieve effectively pain in cervical type of CS and the efficacy is superior to the simple chiropractic spinal manipulation .
-
-###24878085
-BACKGROUND	Recently it has been reported a benefit effect with the use of metformin in patients with malignant disease .
-BACKGROUND	Our objective was to evaluate the effect of adding metformin to chemotherapy regimen over the percentage of early relapse in acute lymphoblastic leukemia .
-METHODS	A prospective , longitudinal and experimental study was performed in patients with de novo acute lymphoblastic leukemia enrolled in the Hospital General de Mxico .
-METHODS	They were divided in two groups : first group received chemotherapy + metformin ( 850 mg three times a day ) ; second group only received standard chemotherapy .
-METHODS	The sample was randomized 3:1 in favor of the second group .
-RESULTS	93 patients were included ( 73 treated with chemotherapy + metformin and 20 received standard chemotherapy ) , with 303 53 days of follow-up .
-RESULTS	Complete remission was higher in the group without metformin ( 81.3 % [ n = 61 ] versus 70 % [ n = 14 ] ) , which also presented more patients with relapse ( 47.9 % versus 25 % ) .
-RESULTS	Overall survival at one year was of 68 % and free survival disease was 64 % , without significant differences between groups .
-RESULTS	Absence of metformin was the only variable of adverse prognostic considered significant ( p = 0.55 ) .
-RESULTS	Cox regression showed that adding metfomin reduced 56 % the risk of relapse .
-CONCLUSIONS	The adding metformin to the treatment of leukemias showed that was useful in our research .
-CONCLUSIONS	However , randomized and double-blind studies must be designed in order to express final recommendations about its use .
-
-###24384646
-OBJECTIVE	To determine whether smaller brain volumes in older women who had completed Women 's Health Initiative ( WHI ) - assigned conjugated equine estrogen-based hormone therapy ( HT ) , reported by WHI Memory Study ( WHIMS ) - MRI , correspond to a continuing increased rate of atrophy an average of 6.1 to 7.7 years later in WHIMS-MRI2 .
-METHODS	A total of 1,230 WHI participants were contacted : 797 ( 64.8 % ) consented , and 729 ( 59 % ) were rescanned an average of 4.7 years after the initial MRI scan .
-METHODS	Mean annual rates of change in total brain volume , the primary outcome , and rates of change in ischemic lesion volumes , the secondary outcome , were compared between treatment groups using mixed-effect models with adjustment for trial , clinical site , age , intracranial volumes , and time between MRI measures .
-RESULTS	Total brain volume decreased an average of 3.22 cm ( 3 ) / y in the active arm and 3.07 cm ( 3 ) / y in the placebo arm ( p = 0.53 ) .
-RESULTS	Total ischemic lesion volumes increased in both arms at a rate of 0.12 cm ( 3 ) / y ( p = 0.88 ) .
-CONCLUSIONS	Conjugated equine estrogen-based postmenopausal HT , previously assigned at WHI baseline , did not affect rates of decline in brain volumes or increases in brain lesion volumes during the 4.7 years between the initial and follow-up WHIMS-MRI studies .
-CONCLUSIONS	Smaller frontal lobe volumes were observed as persistent group differences among women assigned to active HT compared with placebo .
-CONCLUSIONS	Women with a history of cardiovascular disease treated with active HT , compared with placebo , had higher rates of accumulation in white matter lesion volume and total brain lesion volume .
-CONCLUSIONS	Further study may elucidate mechanisms that explain these findings .
-
-###26179814
-BACKGROUND	Surgical patients are at risk of adverse drug events ( ADEs ) causing morbidity and mortality .
-BACKGROUND	Much harm is preventable .
-BACKGROUND	Ward-based pharmacy interventions to reduce medication-related harm have not been evaluated in surgical patients .
-METHODS	This multicentre prospective clinical trial evaluated a protocolled , ward-based pharmacy method compared with standard pharmaceutical care in surgical patients .
-METHODS	Allocation of study group was done by one-time randomization at ward level .
-METHODS	Consecutive patients admitted for elective surgery with an expected hospital stay longer than 48 h were included .
-METHODS	Pharmacy practitioners performed bedside medication reconciliation at admission and discharge , and hospital pharmacists undertook regular medication reviews in the study wards .
-METHODS	Preventable ADEs and clinical outcomes were assessed .
-RESULTS	A total of 1094 surgical patients were studied .
-RESULTS	Some 880 specific interventions were made by the hospital pharmacist to improve pharmacotherapy in 309 of 547 patients on study wards .
-RESULTS	A further 547 patients were included on control wards .
-RESULTS	A crude non-significant reduction in incidence of preventable ADEs was seen on intervention wards in comparison with control wards ( 2.74 versus 3.84 preventable ADEs per 100 admissions ; incidence rate ratio 0.71 , 95 per cent c.i. 0.37 to 1.39 ; P = 0.324 ) .
-RESULTS	After adjustment for differences in treatment groups and for potential confounding , the incidence rate ratio remained non-significant ( 0.82 , 0.39 to 1.72 ; P = 0.598 ) .
-RESULTS	No differences were seen for other outcomes , such as duration of hospital stay , number of complications and quality of life .
-CONCLUSIONS	The present prospective controlled trial showed no significant reduction in medication-related harm or changes in clinical outcomes when surgical patients received protocolled ward-based pharmacy interventions .
-
-###25923552
-BACKGROUND	The Diabetes Control and Complications Trial ( DCCT ) showed a beneficial effect of 6.5 years of intensive glycemic control on retinopathy in patients with type 1 diabetes .
-METHODS	Between 1983 and 1989 , a total of 1441 patients with type 1 diabetes in the DCCT were randomly assigned to receive either intensive diabetes therapy or conventional therapy aimed at preventing hyperglycemic symptoms .
-METHODS	They were treated and followed until 1993 .
-METHODS	Subsequently , 1375 of these patients were followed in the observational Epidemiology of Diabetes Interventions and Complications ( EDIC ) study .
-METHODS	The self-reported history of ocular surgical procedures was obtained annually .
-METHODS	We evaluated the effect of intensive therapy as compared with conventional therapy on the incidence and cost of ocular surgery during these two studies .
-RESULTS	Over a median follow-up of 23 years , 130 ocular operations were performed in 63 of 711 patients assigned to intensive therapy ( 8.9 % ) and 189 ocular operations in 98 of 730 patients assigned to conventional therapy ( 13.4 % ) ( P < 0.001 ) .
-RESULTS	After adjustment for DCCT baseline factors , intensive therapy was associated with a reduction in the risk of any diabetes-related ocular surgery by 48 % ( 95 % confidence interval [ CI ] , 29 to 63 ; P < 0.001 ) and a reduction in the risk of all such ocular procedures by 37 % ( 95 % CI , 12 to 55 ; P = 0.01 ) .
-RESULTS	Forty-two patients who received intensive therapy and 61 who received conventional therapy underwent cataract extraction ( adjusted risk reduction with intensive therapy , 48 % ; 95 % CI , 23 to 65 ; P = 0.002 ) ; 29 patients who received intensive therapy and 50 who received conventional therapy underwent vitrectomy , retinal-detachment surgery , or both ( adjusted risk reduction , 45 % ; 95 % CI , 12 to 66 ; P = 0.01 ) .
-RESULTS	The costs of surgery were 32 % lower in the intensive-therapy group .
-RESULTS	The beneficial effects of intensive therapy were fully attenuated after adjustment for mean glycated hemoglobin levels over the entire follow-up .
-CONCLUSIONS	Intensive therapy in patients with type 1 diabetes was associated with a substantial reduction in the long-term risk of ocular surgery .
-CONCLUSIONS	( Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others ; DCCT/EDIC ClinicalTrials.gov numbers , NCT00360893 and NCT00360815 . )
-
-###24792106
-OBJECTIVE	To compare the safety and efficacy of microcoaxial phacoemulsification surgeries performed with the OZil Intelligent Phaco torsional mode ( Alcon Laboratories , Inc. , Fort Worth , USA ) and combined torsional/longitudinal ultrasound mode using 45 degree aperture angled tips .
-METHODS	Prospective randomized clinical trial .
-METHODS	setting : Maltepe University , Istanbul .
-METHODS	patient population : Eighty eyes of 80 cataract patients were randomly assigned to 2.2 mm microcoaxial phacoemulsification using the OZil Intelligent Phaco torsional mode ( Group 1 ) or combined torsional/longitudinal ultrasound mode ( Group 2 ) .
-METHODS	observation procedure : Intraoperative fluid and energy usage and postoperative examinations were evaluated .
-METHODS	main outcome measures : Ultrasound time , cumulative dissipated energy , longitudinal and torsional ultrasound amplitudes , mean operation time , mean volume of fluid used , and surgical complications .
-RESULTS	Both groups included 40 eyes .
-RESULTS	Mean ultrasound time , cumulative dissipated energy , and longitudinal and torsional ultrasound amplitudes in Group 1 were 58.2133.81 seconds , 7.746.23 , 0.450.30 , and 26.3012.60 % , respectively , and these parameters in Group 2 were 64.7530.23 seconds , 12.616.21 , 26.325.85 , and 40.988.33 % , respectively .
-RESULTS	Cumulative dissipated energy and longitudinal and torsional amplitudes were found to be significantly lower in Group 1 ( P = .001 , P < .001 , P < .001 ) .
-RESULTS	Mean volumes of fluid used in Groups 1 and 2 were 73.3019.87 cc and 107.0721.82 cc , respectively ( P < .001 ) .
-CONCLUSIONS	With the aid of a 45 degree aperture angled tip , the OZil Intelligent Phaco torsional mode provided more effective lens removal than the combined torsional/longitudinal ultrasound mode , with a lower cumulative dissipated energy and volume of fluid used .
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-###24356749
-OBJECTIVE	The aim of this study was to investigate whether genetic variance can influence the efficacy of glibenclamide in patients with type 2 diabetes .
-METHODS	A total of 747 patients with type 2 diabetes was enrolled from the Xiaoke Pills Clinical Trial , which is a double-blind , randomised controlled trial .
-METHODS	All the patients had been treated with glibenclamide for 48 weeks , with strict drug dose adjustment and data collection .
-METHODS	Treatment failure was confirmed when patients reached the criteria for terminating their participation in the study ( fasting blood glucose level 7.0 mmol/l on two consecutive tests 4 weeks after reaching the pre-set maximal dose or maximal tolerated dose ) .
-METHODS	Using this cohort , we tested 44 single-nucleotide polymorphisms ( SNPs ) in 27 gene regions .
-METHODS	The genes in our study were involved in the metabolism of sulfonylureas , islet beta cell function , insulin resistance and beta cell growth and differentiation .
-METHODS	A logistic regression model was used to evaluate the relationship between genetic variants and treatment failure over a period of 48 weeks .
-RESULTS	We found that no SNP reached the significance level of p < 0.00125 if Bonferroni correction was performed for multiple testing in the logistic regression model used in this pharmacogenetic study .
-RESULTS	Participants with the minor allele C of rs10811661 in CDKN2A/CDKN2B showed a significantly greater reduction in fasting blood glucose ( TT vs TC vs CC : 9.3 % ( 0-20 .0 % ) vs 9.2 % ( 0.9-20 .5 % ) vs 12.7 % ( 5.2-24 .4 % ) , p = 0.008 ) after the initial 4 weeks of treatment independent of age , sex and BMI .
-RESULTS	There was a significant difference in beta cell function among carriers of different genotypes of rs10811661 .
-CONCLUSIONS	Our study demonstrated that the CDKN2A/CDKN2B gene may be nominally associated with the efficacy of glibenclamide , and that CDKN2A/CDKN2B is associated with beta cell function .
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-###25346376
-OBJECTIVE	The effect of the Pillar implant on mild sleep-disordered breathing ( SDB ) has been assessed in various studies .
-OBJECTIVE	However , most of these were conducted among a non-Asian population at a single institution .
-OBJECTIVE	Therefore , the aim of this study was to prospectively evaluate the efficacy of the Pillar implant in Asian patients with simple snoring and mild obstructive sleep apnea ( OSA ) at multiple centers .
-METHODS	Multicenter prospective clinical trials .
-METHODS	This study included consecutive subjects with simple snoring or mild OSA .
-METHODS	We examined subjective symptoms ( snoring intensity , frequency , witnessed apnea , and daytime sleepiness ) and objective snoring and respiratory parameters ( snoring duration [ proportion of sleep while snoring louder than 50 dB ] , snoring loudness , apnea-hypopnea index , respiratory disturbance index , minimum arterial oxygen saturation , and oxygen desaturation index4 % ) at 3 to 6 months after surgery .
-METHODS	Adverse events were also investigated .
-RESULTS	Twenty-nine subjects with mild SDB completed the study .
-RESULTS	Whole group analysis found significant improvements in various subjective symptoms , but not in the objective snoring and respiratory parameters .
-RESULTS	A subgroup analysis of subjects with mild OSA ( n = 11 ) found significant alleviation in various subjective symptoms , apnea-hypopnea index , respiratory disturbance index , and oxygen desaturation index4 % .
-RESULTS	No major complication related to surgery was observed , and most minor adverse effects were resolved without morbidity .
-CONCLUSIONS	In selected Korean patients , the Pillar implant significantly improved not only subjective symptoms of mild SDB but also respiratory disturbances in mild OSA .
-METHODS	2b .
-
-###25109754
-OBJECTIVE	The study objective was to determine the impact of diabetes on radial artery and saphenous vein graft occlusion and clinical outcomes more than 5 years after coronary artery bypass surgery in the multicenter Radial Artery Patency Study ( NCT00187356 ) .
-METHODS	A total of 529 patients aged less than 80 years with triple-vessel disease undergoing coronary bypass surgery participated in this study .
-METHODS	Angiographic follow-up occurred more than 5 years after surgery with annual clinical follow-up .
-METHODS	The primary objective was to compare the proportion of complete graft occlusion between radial artery and saphenous vein grafts among diabetic and nondiabetic persons .
-METHODS	Additional objectives included determining predictors of complete graft occlusion and comparison of major adverse cardiac events defined by cardiac death , late myocardial infarction , and reintervention .
-RESULTS	There were 148 of 529 patients ( 27.8 % ) with diabetes ; 269 patients ( 83/269 [ 30.9 % ] diabetic ) underwent late angiography at mean of 7.71.5 years after surgery .
-RESULTS	In diabetic patients , the proportion of complete graft occlusion was significantly lower in the radial grafts ( 4/83 [ 4.8 % ] ) than in the saphenous grafts ( 21/83 [ 25.3 % ] ) ( P = .0004 ) , and this was similar in nondiabetic patients ( P = .19 ) .
-RESULTS	Multivariate modeling showed that the use of the radial artery and high-grade target vessel stenosis were protective against late graft occlusion , whereas female gender , smoking history , and elevated creatinine were associated with an increased risk ; interaction between diabetic status and conduit type also was significant ( P = .02 ) .
-RESULTS	Major adverse cardiac events were higher in diabetic patients ( 23/148 [ 15.5 % ] vs 35/381 [ 9.2 % ] , P = .04 ) .
-CONCLUSIONS	The use of the radial artery should be strongly considered in diabetic patients undergoing coronary bypass surgery , especially with high-grade target vessel stenosis .
-
-###24738516
-BACKGROUND	Andropause and aging are associated with neuroendocrine dysfunctions .
-BACKGROUND	Growth hormone and testosterone play a significant role in several processes affecting adaptation and thereby also everyday functioning .
-BACKGROUND	The aim of this research project was to evaluate the effects of recombinant human growth hormone and testosterone enanthate injections on body mass and body composition , aerobic and anaerobic fitness and lipid profile in middle-aged men .
-METHODS	The research group was comprised of 14 men aged 45 - 60 years .
-METHODS	Two series of laboratory analyses were performed .
-METHODS	Independent tests were carried out at baseline and after 12 weeks of the experiment .
-METHODS	The data were analyzed using Statistica 9.1 software .
-RESULTS	A two-way repeated measures ANOVA revealed a statistically significant effect of the intervention programme on fat-free mass ( ( 2 ) = 0.34 ) , total body fat ( ( 2 ) = 0.79 ) , total cholesterol ( ( 2 ) = 0.30 ) , high-density lipoprotein cholesterol ( ( 2 ) = 0.31 ) , low-density lipoprotein cholesterol ( ( 2 ) = 0.42 ) , triglyceride ( ( 2 ) = 0.28 ) , testosterone ( ( 2 ) = 0.52 ) , insulin-like growth factor 1 ( ( 2 ) = 0.47 ) and growth hormone ( ( 2 ) = 0.63 ) .
-RESULTS	Furthermore , ANOVA revealed a statistically significant effect of the rhGH and T treatment on maximal oxygen uptake ( ( 2 ) = 0.63 ) , anaerobic threshold ( ( 2 ) = 0.61 ) and maximal work rate ( ( 2 ) = 0.53 ) .
-CONCLUSIONS	It should be emphasized that the lipid profile was affected not only by rhGH + T replacement therapy , but also by the prescribed physical activity programme .
-CONCLUSIONS	The strength and endurance fitness programme alone did not cause significant changes in body mass and composition , nor the anaerobic and aerobic capacity .
-CONCLUSIONS	On the other hand , the rhGH = T treatment stimulated these changes significantly .
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-###25488897
-OBJECTIVE	The objective of this study was to compare participation rates and clinical effectiveness of sedated esophagogastroduodenoscopy ( sEGD ) and unsedated transnasal endoscopy ( uTNE ) for esophageal assessment and Barrett 's esophagus ( BE ) screening in a population-based cohort .
-METHODS	This was a prospective , randomized , controlled trial in a community population .
-METHODS	Subjects 50 years of age who previously completed validated gastrointestinal symptom questionnaires were randomized ( stratified by age , sex , and reflux symptoms ) to one of three screening techniques ( either sEGD or uTNE in a mobile research van ( muTNE ) or uTNE in a hospital outpatient endoscopy suite ( huTNE ) ) and invited to participate .
-RESULTS	Of the 459 subjects , 209 ( 46 % ) agreed to participate ( muTNE n = 76 , huTNE n = 72 , and sEGD n = 61 ) .
-RESULTS	Participation rates were numerically higher in the unsedated arms of muTNE ( 47.5 % ) and huTNE ( 45.7 % ) compared with the sEGD arm ( 40.7 % ) , but were not statistically different ( P = 0.27 ) .
-RESULTS	Complete evaluation of the esophagus was similar using muTNE ( 99 % ) , huTNE ( 96 % ) , and sEGD ( 100 % ) techniques ( P = 0.08 ) .
-RESULTS	Mean recovery times ( min ) were longer for sEGD ( 67.3 ) compared with muTNE ( 15.5 ) and huTNE ( 18.5 ) ( P < 0.001 ) .
-RESULTS	Approximately 80 % of uTNE subjects were willing to undergo the procedure again in future .
-RESULTS	Respectively , 29 % and 7.8 % of participating subjects had esophagitis and BE .
-CONCLUSIONS	Mobile van and clinic uTNE screening had comparable clinical effectiveness with similar participation rates and safety profile to sEGD .
-CONCLUSIONS	Evaluation time with uTNE was significantly shorter .
-CONCLUSIONS	Prevalence of BE and esophagitis in community subjects 50 years of age was substantial .
-CONCLUSIONS	Mobile and outpatient unsedated techniques may provide an effective alternative strategy to sEGD for esophageal assessment and BE screening .
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-###25945691
-OBJECTIVE	Although medical intervention is the first option for treatment of nasal polyps , surgery is still a therapeutic option for symptomatic cases that do not respond or partially respond to medical intervention .
-OBJECTIVE	However , there is a need for high-level evidence for the preoperative use of steroids in nasal polyposis surgery .
-OBJECTIVE	We aimed to assess the perioperative effect of preoperative use of oral prednisolone for advanced-stage diffuse nasal polyposis .
-METHODS	Prospective , double-blind , randomized , placebo-controlled study .
-METHODS	A visual analog scale ( VAS ) was evaluated for smell , nasal discharge , nasal obstruction , facial pressure , headache , butanol smell threshold , and peak nasal inspiratory flow ( PNIF ) before and after the use of study drug .
-METHODS	Perioperative bleeding volume , visibility of operative field , operative time , hospital stay , and complication rate were also evaluated .
-RESULTS	The improvement in the corticosteroid group ( CG ) in the VAS scores , butanol thresholds , and PNIF values showed statistically significant differences compared to the placebo group ( PG ) ( P < .05 ) .
-RESULTS	The perioperative bleeding volume , visibility score , operative time , and hospital stay for CG/PG were 141 mL/384 mL , 2.4 / 3.4 , 61 min/71 .6 min , and 1.1 day/1 .8 day , respectively ( P < .05 ) .
-RESULTS	The difference between the complication rates for the two groups did not show any statistically significant difference ( P = .214 ) .
-CONCLUSIONS	Preoperative administration of systemic corticosteroids improves the perioperative visibility by reducing blood loss and shortens the operation time .
-CONCLUSIONS	We recommend the use of preoperative corticosteroid for the safety of the patients .
-CONCLUSIONS	The optimum dose and duration have not been established and require further studies .
-METHODS	1b .
-
-###24470436
-OBJECTIVE	Observational studies suggest that hydroxychloroquine ( HCQ ) may reduce the risk of developing diabetes mellitus in patients with rheumatoid arthritis ( RA ) .
-OBJECTIVE	We examined the effect of HCQ on insulin resistance in subjects without diabetes mellitus with stable RA .
-METHODS	Twenty-three RA subjects not currently using HCQ completed a 16-week , double-blind crossover study .
-METHODS	Subjects were randomly allocated to receive HCQ ( 6.5 mg/kg/day ) or placebo for the first 8 weeks , followed by crossover to the other arm for the final 8 weeks .
-METHODS	Subjects underwent oral glucose tolerance testing and fasting lipid measurements at baseline , 8 weeks , and 16 weeks .
-METHODS	The change SD from baseline in insulin sensitivity index ( ISI ) , homeostatic model assessment for insulin resistance ( HOMA-IR ) , and lipid parameters were compared between placebo and HCQ using linear regression .
-RESULTS	The mean patient age was 56 years , with 96 % women , and the median body mass index was 26.0 kg/m2 .
-RESULTS	After 8 weeks of HCQ , the mean SD ISI increase was 0.4 2.9 compared with a small increase during placebo of 0.14 3.1 ( adjusted P = 0.785 ) , and the mean SD HOMA-IR decrease was 0.3 1.5 during HCQ versus a decrease of 0.42 1.4 during placebo ( adjusted P = 0.308 ) .
-RESULTS	Small decreases in total cholesterol ( 12.7 mg/dl ) and low-density lipoprotein ( LDL ) cholesterol ( 12.4 mg/dl ) were observed during the HCQ treatment periods ( both adjusted P < 0.05 compared to placebo ) .
-CONCLUSIONS	HCQ use for 8 weeks in patients without diabetes mellitus with stable RA produced no significant change in insulin resistance .
-CONCLUSIONS	We observed small and statistically significant improvements in total and LDL cholesterol during HCQ treatment .
-
-###24428951
-BACKGROUND	Breastfeeding has countless benefits to mothers , children and community at large , especially in developing countries .
-BACKGROUND	Studies from Lebanon report disappointingly low breastfeeding exclusivity and continuation rates .
-BACKGROUND	Evidence reveals that antenatal breastfeeding education , professional lactation support , and peer lay support are individually effective at increasing breastfeeding duration and exclusivity , particularly in low-income settings .
-BACKGROUND	Given the complex nature of the breastfeeding ecosystem and its barriers in Lebanon , we hypothesize that a complex breastfeeding support intervention , which is centered on the three components mentioned above , would significantly increase breastfeeding rates .
-METHODS	A multi-center randomized controlled trial .
-METHODS	443 healthy pregnant women in their first trimester will be randomized to control or intervention group .
-METHODS	A `` prenatal/postnatal '' professional and peer breastfeeding support package continuing till 6 months postpartum , guided by the Social Network and Social Support Theory .
-METHODS	Control group will receive standard prenatal and postnatal care .
-METHODS	Mothers will be followed up from early pregnancy till five years after delivery .
-METHODS	Total and exclusive breastfeeding rates , quality of life at 1 , 3 and 6 months postpartum , maternal breastfeeding knowledge and attitudes at 6 months postpartum , maternal exclusive breastfeeding rates of future infants up to five years from baseline , cost-benefit and cost-effectiveness analyses of the intervention .
-METHODS	Descriptive and regression analysis will be conducted under the intention to treat basis using the most recent version of SPSS .
-CONCLUSIONS	Exclusive breastfeeding is a cost-effective public health measure that has a significant impact on infant morbidity and mortality .
-CONCLUSIONS	In a country with limited healthcare resources like Lebanon , developing an effective breastfeeding promotion and support intervention that is easily replicated across various settings becomes a priority .
-CONCLUSIONS	If positive , the results of this study would provide a generalizable model to bolster breastfeeding promotion efforts and contribute to improved child health in Lebanon and the Middle East and North Africa ( MENA ) region .
-BACKGROUND	Current Controlled Trials ISRCTN17875591 .
-
-###24935020
-OBJECTIVE	Beta-blockers ( BBs ) improve outcomes in heart failure .
-OBJECTIVE	Results from the Cardiac Insufficiency Bisoprolol Study in Elderly ( CIBIS-ELD ) trial previously demonstrated the feasibility of heart rate , not maximum dose , as a treatment goal .
-OBJECTIVE	In this pre-specified analysis , we investigated the prognostic value of achieved heart rate after BB optimization on long-term mortality .
-RESULTS	Elderly heart failure patients from the CIBIS-ELD trial were invited to participate in a follow-up examination 4 years after the initial 12-week BB up-titration period .
-RESULTS	The relationship between all-cause mortality , BB dose , and heart rate after titration and potentially confounding clinical variables was analysed by multivariable Cox regression .
-RESULTS	In total , 728 patients ( 38 % women ; mean age 72.9 5.4 years ) were included .
-RESULTS	During a mean follow-up period of 45 9 months , 134 patients ( 19 % ) died , thus accumulating 2268 patient-years at risk .
-RESULTS	There was no significant difference in baseline heart rate for survivors and non-survivors ( P = 0.19 ) .
-RESULTS	In models adjusting for age , sex , BB pre-treatment , ventricular function , heart rate , and NYHA class at baseline , a heart rate increase by 10 b.p.m. following up-titration was associated with a subsequent mortality hazard ratio of 1.19 ( 95 % confidence interval 1.02-1 .38 , P = 0.023 ) .
-RESULTS	The heart rate range with the lowest mortality and the fewest treatment-related adverse events was 55-64 b.p.m.
-RESULTS	The achieved BB dose was not associated with mortality risk .
-CONCLUSIONS	The heart rate after up-titration , but not BB dose , predicted all-cause mortality risk in elderly patients with chronic heart failure .
-CONCLUSIONS	These patients should be titrated to resting heart rates between 55 and 64 b.p.m.
-
-###24518763
-OBJECTIVE	Regional analgesic techniques are commonly used in pediatric urology .
-OBJECTIVE	Ultrasound guided transversus abdominis plane block has recently gained popularity .
-OBJECTIVE	However , there is a paucity of information supporting a benefit over regional field infiltration .
-OBJECTIVE	We present a parallel group , randomized , controlled trial evaluating ultrasound guided transversus abdominis plane block superiority over surgeon delivered regional field infiltration for children undergoing open pyeloplasty at a tertiary referral center .
-METHODS	Following ethics board approval and registration , children 0 to 6 years old were recruited and randomized to undergo perioperative transversus abdominis plane block or regional field infiltration for early post-pyeloplasty pain control .
-METHODS	General anesthetic delivery , surgical technique and postoperative analgesics were standardized .
-METHODS	A blinded assessor regularly captured pain scores in the recovery room using the FLACC ( Face , Legs , Activity , Cry , Consolability ) scale .
-METHODS	The primary outcome was the need for rescue morphine administration based on a FLACC score of 3 or higher .
-RESULTS	Two pediatric urologists performed 57 pyeloplasties during a 2.5-year period , enrolling 32 children ( 16 in each group , balanced for age and weight ) .
-RESULTS	There were statistically significant differences in the number of children requiring rescue morphine administration ( 13 of 16 receiving transversus abdominis plane block and 6 of 16 receiving regional field infiltration , p = 0.011 ) , mean SD total morphine consumption ( 0.066 0.051 vs 0.028 0.040 mg/kg , p = 0.021 ) and mean SD pain scores ( 5 5 vs 2 3 , p = 0.043 ) in the recovery room , in favor of surgeon administered regional field infiltration .
-RESULTS	No local anesthetic specific adverse events were noted .
-CONCLUSIONS	Ultrasound guided transversus abdominis plane block is not superior to regional field infiltration with bupivacaine as a strategy to minimize early opioid requirements following open pyeloplasty in children .
-CONCLUSIONS	Instead , our data suggest that surgeon delivered regional field infiltration provides better pain control .
-
-###24305430
-BACKGROUND	The addition of hydrophobically modified polymers ( HMPs ) to cleansers that contain surfactants can create polymer-surfactant complexes that are less irritating to the skin than commercially available mild cleansers .
-BACKGROUND	Our objective was to compare the tolerability and efficacy of a test foaming liquid facial cleanser containing HMPs with a commercial liquid nonfoaming facial cleanser in women with sensitive skin .
-METHODS	In this randomized , prospective , double-blind , comparative study , women ( n = 20 per group ) with mild-to-moderate atopic dermatitis ( AD ) , eczema , acne , or rosacea used a test gentle foaming liquid facial cleanser containing HMPs or a commercial gentle liquid nonfoaming facial cleanser daily for 3weeks .
-METHODS	Investigators assessed irritation and skin condition .
-METHODS	Study subjects also assessed their skin properties and the performance of each cleanser .
-RESULTS	Clinicians as well as study subjects consistently rated the test cleanser as effective or slightly more effective at improving symptoms than the commercial cleanser , although no significant differences between groups were observed .
-RESULTS	At weeks 1 and 3 , respectively , more users of the commercial cleanser reported irritation ( 20 % and 10 % ) than users of the test cleanser ( 5 % and 5 % ) .
-RESULTS	In addition , subject self-assessments of skin condition and cleansing properties were slightly more improved with the test cleanser than with the commercial cleanser .
-CONCLUSIONS	Both the test foaming cleanser containing HMPs and the commercial nonfoaming cleanser were effective and well accepted by most women in the study .
-CONCLUSIONS	Improvements were observed by both clinicians and subjects in the group using the test cleanser containing HMPs in all evaluated skin categories .
-
-###24684105
-OBJECTIVE	To determine the safety and effectiveness of electroacupuncture ( EA ) intervention combined with general anesthesia ( GA ) for craniocerebral tumor-removal surgery involving cerebral eloquent areas .
-METHODS	A total of 20 patients with cerebral tumors ( durosarcoma , neurogliocytoma , metastatic tumor ) involving the cerebral eloquent areas were recruited in the present summary .
-METHODS	They were equally divided into general anesthesia ( GA ) group and EA + GA group .
-METHODS	Patients of the EA + GA group were treated with EA stimulation ( 2 Hz/100 Hz ) of the bilateral Fengchi ( GB 20 ) , Shuaigu ( GB 8 ) and acupuncture stimulation of Quanliao ( SI 18 ) , Zulinqi ( GB 41 ) and Taichong ( LR 3 ) , and not given intubation during surgery .
-METHODS	Patients of the GA group were treated with intravenous administration of Propofol , Fentanyl , Midazolam , Isopropanol , etc. .
-METHODS	In addition , all the patients were given with controlled hypotension by intravenous injection of Propofol and Fentanyl .
-METHODS	Dosages of Propofol and Sulfentanyl used were recorded .
-METHODS	Karnofsky performance status scale was used to assess the patient 's general well-being and activities of daily life .
-RESULTS	The craniocerebral tumor-removal surgery was successful in all the 20 patients .
-RESULTS	Compared with the GA group , the dosages of Sulfentanyl and Propofol of the EA + GA group were significantly lower ( P < 0.05 ) .
-RESULTS	No significant difference was found between the GA and EA + GA groups in Karnofsky performance scores ( P > 0.05 ) .
-RESULTS	Patients of the EA+GA group experienced successful tumour-removal surgery without trachea cannula , were awake and could make a good cooperation with the operator during surgery .
-RESULTS	They had no aggravation of neurofunctional disturbance following the operation .
-CONCLUSIONS	EA combined with general anesthesia is safe and effective for patients with craniocerebral tumor-removal operations involving cerebral eloquent areas .
-
-###25139724
-OBJECTIVE	To determine if intrauterine administration of 5 cc of 2 % lidocaine in addition to paracervical block reduces pain during laminaria insertion , when compared with paracervical block and saline placebo .
-METHODS	This was a randomized , double blind placebo-controlled trial .
-METHODS	Women presenting for abortion by dilation and evacuation ( D&E ) at 14-24 weeks gestational age were randomized to receive an intrauterine instillation of either 5 mL of 2 % lidocaine or 5 mL of normal saline , in addition to standard paracervical block with 20 cc of 0.25 % bupivacaine .
-METHODS	Our primary outcome was self-reported pain scores on a 100mm Visual Analogue Scale ( VAS ) immediately following laminaria insertion .
-METHODS	Secondary outcome was self-reported VAS pain score indicating the maximum level of pain experienced during the 24-48-h interval between laminaria insertion and D&E procedure .
-RESULTS	Seventy-two women were enrolled , and data for 67 women were analyzed , only two of whom were more than 21 weeks on gestation .
-RESULTS	The range of pain scores at both time points was large ( 1-90 mm at laminaria insertion ; 0-100mm in laminaria-D & E interval ) .
-RESULTS	Mean pain scores were not different between treatment groups at laminaria insertion , ( 33 vs. 32 , p = .8 ) or in the laminaria - D&E interval ( 43 vs. 44 , p = .9 ) .
-CONCLUSIONS	Intrauterine administration of 5 cc of 2 % lidocaine in addition to paracervical block did not reduce pain with laminaria insertion when compared to paracervical block with saline placebo .
-CONCLUSIONS	Intrauterine lidocaine combined with paracervical block does not improve pain control at laminaria insertion when compared with paracervical block and saline placebo .
-CONCLUSIONS	Wide variation in pain scores and persistent pain after laminaria insertion suggests patient would benefit from more effective methods of pain control at laminaria insertion and during the post-laminaria interval .
-
-###25256368
-BACKGROUND	Our aim was to determine if a surgeon 's behaviors can encourage or discourage trainees from speaking up when they witness a surgical mistake .
-METHODS	A randomized clinical trial in which medical students ( n = 55 ) were randomly assigned to an `` encouraged '' ( n = 28 ) or `` discouraged '' ( n = 27 ) group .
-METHODS	Participants underwent personality tests to assess decision-making styles , and were then trained on basic tasks ( `` burn '' then `` cut '' ) on a laparoscopic surgery simulator .
-METHODS	After randomization , students assisted at a simulated laparoscopic salpingectomy .
-METHODS	The senior surgeon used either an `` encourage '' script ( eg , `` Your opinion is important . '' )
-METHODS	or a `` discourage '' script ( eg , `` Do what I say .
-METHODS	Save questions for next time . '' )
-METHODS	Otherwise , the surgery was conducted identically .
-METHODS	Subsequently , a surgical mistake was made by the senior surgeon when he instructed students to cut without burning .
-METHODS	Students were considered to have spoken up if they questioned the instruction and did not cut .
-METHODS	Potential personality bias was assessed with two validated personality tests before simulation .
-METHODS	Data were processed with Mann-Whitney and Fisher exact tests .
-RESULTS	The students in the encouraged group were significantly more likely to speak up ( 23 of 28 [ 82 % ] vs 8 of 27 [ 30 % ] ; p < 0.001 ) .
-RESULTS	There was no statistically significant difference between the two groups in personality traits , student training level ( p = 1.0 ) , or sex ( p = 0.53 ) .
-CONCLUSIONS	A discouraging environment decreases the frequency with which trainees speak up when witnessing a surgical error .
-CONCLUSIONS	The senior surgeon plays an important role in improving intraoperative communication between junior and senior clinicians and can enhance patient safety .
-
-###24913003
-BACKGROUND	Despite growing emphasis on transitional care to reduce costs and improve quality , few studies have examined transitional care improvements in socioeconomically disadvantaged adults .
-BACKGROUND	It is important to consider these patients separately as many are high-utilizers , have different needs , and may have different responses to interventions .
-OBJECTIVE	To evaluate the impact of a multicomponent transitional care improvement program on 30-day readmissions , emergency department ( ED ) use , transitional care quality , and mortality .
-METHODS	Clustered randomized controlled trial conducted at a single urban academic medical center in Portland , Oregon .
-METHODS	Three hundred eighty-two hospitalized low-income adults admitted to general medicine or cardiology who were uninsured or had public insurance .
-METHODS	Multicomponent intervention including ( 1 ) transitional nurse coaching and education , including home visits for highest risk patients ; ( 2 ) pharmacy care , including provision of 30 days of medications after discharge for those without prescription drug coverage ; ( 3 ) post-hospital primary care linkages ; ( 4 ) systems integration and continuous quality improvement .
-METHODS	Primary outcomes included 30-day inpatient readmission and ED use .
-METHODS	Readmission data were obtained using state-wide administrative data for all participants ( insured and uninsured ) .
-METHODS	Secondary outcomes included quality ( 3-item Care Transitions Measure ) and mortality .
-METHODS	Research staff administering questionnaires and assessing outcomes were blinded .
-RESULTS	There was no significant difference in 30-day readmission between C-TraIn ( 30/209 , 14.4 % ) and control patients ( 27/173 , 16.1 % ) , p = 0.644 , or in ED visits between C-TraIn ( 51/209 , 24.4 % ) and control ( 33/173 , 19.6 % ) , p = 0.271 .
-RESULTS	C-TraIn was associated with improved transitional care quality ; 47.3 % ( 71/150 ) of C-TraIn patients reported a high quality transition compared to 30.3 % ( 36/119 ) control patients , odds ratio 2.17 ( 95 % CI 1.30-3 .64 ) .
-RESULTS	Zero C-TraIn patients died in the 30-day post-discharge period compared with five in the control group ( unadjusted p = 0.02 ) .
-CONCLUSIONS	C-TraIn did not reduce 30-day inpatient readmissions or ED use ; however , it improved transitional care quality .
-
-###24786469
-OBJECTIVE	To compare the effect of heated , humidified , high-flow nasal cannula ( HHHFNC ) and nasal continuous positive airways pressure ( NCPAP ) on lung function and mechanics in preterm infants with respiratory distress syndrome ( RDS ) at the same level of retropharyngeal pressure ( Prp ) .
-METHODS	Randomised crossover trial .
-METHODS	Neonatal intensive care unit , Ospedale Maggiore Policlinico , Milan , Italy .
-METHODS	20 preterm infants ( gestational age : 311 wks ) with mild-moderate RDS requiring non-invasive respiratory support within 96 h after birth .
-METHODS	Infants were exposed to a randomised sequence of NCPAP and HHHFNC at different settings ( 2 , 4 and 6 cmHO for NCPAP and 2 , 4 , 6 L/min for HHHFNC ) to enable comparison at the same level of Prp .
-METHODS	Tidal volume by respiratory inductance plethysmography , pleural pressure estimated by oesophageal pressure , and gas exchange were evaluated at each setting and used to compute breathing pattern parameters , lung mechanics and work of breathing ( WOB ) .
-RESULTS	A poor linear regression between flow and Prp was found during HHHFNC ( Prp = 0.3 +0.7 * flow ; r = 0.37 ) .
-RESULTS	Only in 15 out of 20 infants it was possible to compare HHHFNC and NCPAP at a Prp of 2 and 4 cmHO .
-RESULTS	No statistically significant differences were found in breathing pattern , gas exchange , lung mechanics and total WOB .
-RESULTS	Resistive WOB in the upper airways was slightly but significantly higher during HHHFNC ( 0.65 ( 0.49 ; 1.09 ) vs 1.57 ( 0.85 ; 2.09 ) cmHO median ( IQR ) ) .
-CONCLUSIONS	Despite differing mechanisms for generating positive airway pressure , when compared at the same Prp , NCPAP and HHHFNC provide similar effects on all the outcomes explored .
-
-###25619520
-BACKGROUND	Recurrent airway obstruction ( RAO ) , an asthma-like disease , is 1 of the most common allergic diseases in horses in the northern hemisphere .
-BACKGROUND	Hypersensitivity reactions to environmental antigens cause an allergic inflammatory response in the equine airways .
-BACKGROUND	Cytosine-phosphate-guanosine-oligodeoxynucleotides ( CpG-ODN ) are known to direct the immune system toward a Th1-pathway , and away from the pro-allergic Th2-line ( Th2/Th1-shift ) .
-BACKGROUND	Gelatin nanoparticles ( GNPs ) are biocompatible and biodegradable immunological inert drug delivery systems that protect CpG-ODN against nuclease degeneration .
-BACKGROUND	Preliminary studies on the inhalation of GNP-bound CpG-ODN in RAO-affected horses have shown promising results .
-OBJECTIVE	The aim of this study was to evaluate the clinical and immunological effects of GNP-bound CpG-ODN in a double-blinded , placebo-controlled , prospective , randomized clinical trial and to verify a sustained effect post-treatment .
-METHODS	Twenty-four RAO-affected horses received 1 inhalation every 2 days for 5 consecutive administrations .
-METHODS	Horses were examined for clinical , endoscopic , cytological , and blood biochemical variables before the inhalation regimen ( I ) , immediately afterwards ( II ) , and 4 weeks post-treatment ( III ) .
-RESULTS	At time points I and II , administration of treatment rather than placebo corresponded to a statistically significant decrease in respiratory effort , nasal discharge , tracheal secretion , and viscosity , AaDO2 and neutrophil percentage , and an increase in arterial oxygen pressure .
-CONCLUSIONS	Administration of a GNP-bound CpG-ODN formulation caused a potent and persistent effect on allergic and inflammatory-induced clinical variables in RAO-affected horses .
-CONCLUSIONS	This treatment , therefore , provides an innovative , promising , and well-tolerated strategy beyond conventional symptomatic long-term therapy and could serve as a model for asthma treatment in humans .
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-###26057285
-OBJECTIVE	Some patients with lower leg amputations may be candidates for motorized prosthetic limbs .
-OBJECTIVE	Optimal control of such devices requires accurate classification of the patient 's ambulation mode ( eg , on level ground or ascending stairs ) and natural transitions between different ambulation modes .
-OBJECTIVE	To determine the effect of including electromyographic ( EMG ) data and historical information from prior gait strides in a real-time control system for a powered prosthetic leg capable of level-ground walking , stair ascent and descent , ramp ascent and descent , and natural transitions between these ambulation modes .
-METHODS	Blinded , randomized crossover clinical trial conducted between August 2012 and November 2013 in a research laboratory at the Rehabilitation Institute of Chicago .
-METHODS	Participants were 7 patients with unilateral above-knee ( n = 6 ) or knee-disarticulation ( n = 1 ) amputations .
-METHODS	All patients were capable of ambulation within their home and community using a passive prosthesis ( ie , one that does not provide external power ) .
-METHODS	Electrodes were placed over 9 residual limb muscles and EMG signals were recorded as patients ambulated and completed 20 circuit trials involving level-ground walking , ramp ascent and descent , and stair ascent and descent .
-METHODS	Data were acquired simultaneously from 13 mechanical sensors embedded on the prosthesis .
-METHODS	Two real-time pattern recognition algorithms , using either ( 1 ) mechanical sensor data alone or ( 2 ) mechanical sensor data in combination with EMG data and historical information from earlier in the gait cycle , were evaluated .
-METHODS	The order in which patients used each configuration was randomized ( 1:1 blocked randomization ) and double-blinded so patients and experimenters did not know which control configuration was being used .
-METHODS	The main outcome of the study was classification error for each real-time control system .
-METHODS	Classification error is defined as the percentage of steps incorrectly predicted by the control system .
-RESULTS	Including EMG signals and historical information in the real-time control system resulted in significantly lower classification error ( mean , 7.9 % [ 95 % CI , 6.1 % -9.7 % ] ) across a mean of 683 steps ( range , 640-756 steps ) compared with using mechanical sensor data only ( mean , 14.1 % [ 95 % CI , 9.3 % -18.9 % ] ) across a mean of 692 steps ( range , 631-775 steps ) , with a mean difference between groups of 6.2 % ( 95 % CI , 2.7 % -9.7 % ] ( P = .01 ) .
-CONCLUSIONS	In this study of 7 patients with lower limb amputations , inclusion of EMG signals and temporal gait information reduced classification error across ambulation modes and during transitions between ambulation modes .
-CONCLUSIONS	These preliminary findings , if confirmed , have the potential to improve the control of powered leg prostheses .
-
-###25127697
-OBJECTIVE	To measure choroidal thickness on spectral-domain optical coherence tomography ( SD OCT ) images using automated algorithms and to correlate choroidal pathology with retinal changes attributable to diabetic macular edema ( DME ) .
-METHODS	Post hoc analysis of multicenter clinical trial baseline data .
-METHODS	SD OCT raster scans/fluorescein angiograms were obtained from 284 treatment-nave eyes of 142 patients with clinically significant DME and from 20 controls .
-METHODS	Three-dimensional ( 3D ) SD OCT images were evaluated by a certified independent reading center analyzing retinal changes associated with diabetic retinopathy .
-METHODS	Choroidal thicknesses were analyzed using a fully automated algorithm .
-METHODS	Angiograms were assessed manually .
-METHODS	Multiple endpoint correction according to Bonferroni-Holm was applied .
-METHODS	Main outcome measures were average retinal/choroidal thickness on fovea-centered or peak of edema ( thickest point of edema ) - centered Early Treatment Diabetic Retinopathy Study grid , maximum area of leakage , and the correlation between retinal and choroidal thicknesses .
-RESULTS	Total choroidal thickness is significantly reduced in DME ( 175 23 m ; P = .0016 ) and nonedematous fellow eyes ( 177 20 m ; P = .009 ) of patients compared with healthy control eyes ( 190 23 m ) .
-RESULTS	Retinal/choroidal thickness values showed no significant correlation ( 1-mm : P = .27 , r ( 2 ) = 0.01 ; 3-mm : P = .96 , r ( 2 ) < 0.0001 ; 6-mm : P = .42 , r ( 2 ) = 0.006 ) .
-RESULTS	No significant difference was found in the 1 - or 3-mm circle of a retinal peak of edema-centered grid .
-RESULTS	All other measurements of choroidal/retinal thickness ( DME vs healthy , DME vs peak of edema-centered , DME vs fellow , healthy vs fellow , peak of edema-centered vs healthy , peak of edema-centered vs fellow eyes ) were compared but no statistically significant correlation was found .
-RESULTS	By tendency a thinner choroid correlates with larger retinal leakage areas .
-CONCLUSIONS	Automated algorithms can be used to reliably assess choroidal thickness in eyes with DME .
-CONCLUSIONS	Choroidal thickness was generally reduced in patients with diabetes if DME is present in 1 eye ; however , no correlation was found between choroidal/retinal pathologies , suggesting different pathogenetic pathways .
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-###24756814
-BACKGROUND	This update of a randomized , prospective study presents the effect of external beam radiation therapy ( EBRT ) on long-term overall survival , local control , and limb function following limb-sparing surgery ( LSS ) for the treatment extremity soft tissue sarcoma ( STS ) .
-METHODS	Following LSS , patients with extremity STS were randomized to receive EBRT or surgery alone .
-METHODS	All patients with high-grade STS received adjuvant chemotherapy .
-METHODS	Long-term follow-up was obtained through telephone interviews using a questionnaire based on validated methods .
-METHODS	Overall survival ( OS ) was determined by Kaplan-Meier method .
-RESULTS	A total of 141 patients with extremity STS were randomized to receive adjuvant EBRT ( n = 70 ) or LSS alone ( n = 71 ) .
-RESULTS	Median follow-up was 17.9 years .
-RESULTS	The 10 - and 20-year survival was 77 % ( 95 % CI 66-85 % ) and 64 % ( 95 % CI 52-75 % ) for patients receiving LSS alone and 82 % ( 95 % CI 72-90 % ) and 71 % ( 95 % CI 59-81 % ) for patients receiving EBRT ( p = 0.22 ) .
-RESULTS	Of the 54 patients who completed telephone interviews , the incidence of local recurrence during the follow-up period was 4 % ( 1 of 24 ) in the LSS alone cohort compared with 0 % ( 0 of 30 ) in those who received EBRT ( p = 0.44 ) .
-RESULTS	Patients treated with EBRT tended to have more wound complications ( 17 vs. 12.5 % , p = 0.72 ) , clinically significant edema ( 25 vs. 12 % , p = 0.31 ) , and functional limb deficits ( 15 vs. 12 % , p = 0.84 ) .
-CONCLUSIONS	Adjuvant EBRT following surgery for STS of the extremity provides excellent local control with acceptable treatment-related morbidity and no statistically significant improvement in overall survival .
-
-###24820932
-OBJECTIVE	In this pilot study we evaluated the feasibility of and methods for assessing the quality of life of long term survivors of European Organisation for Research and Treatment of Cancer ( EORTC ) phase III clinical trials .
-OBJECTIVE	Here we report the results pertaining to the feasibility of conducting such research .
-METHODS	In this cross-sectional study , we recruited long-term , disease-free survivors from two mature EORTC clinical trials in testicular and prostate cancer from centres in Northern and Southern Europe , and the United Kingdom ( UK ) .
-RESULTS	A number of challenges were encountered in recruiting participating centres , obtaining medical ethical approval and in recruiting survivors and collecting the health-related quality of life ( HRQoL ) data in a timely manner .
-RESULTS	The efficiency with which the study could be conducted varied widely across centres and countries .
-RESULTS	Time to obtain medical ethical approval for the study ranged from 1.5 to 25 months .
-RESULTS	We encountered most problems with ethical approval in the UK , Italy and Belgium .
-RESULTS	In most cases , data collection was completed within 3 months ( range 10 weeks-1 year ) .
-RESULTS	Completed questionnaires were obtained from 68 % and 56 % , respectively , of the testicular and prostate cancer survivors who were approached .
-CONCLUSIONS	HRQoL research among long-term survivors of EORTC phase III clinical trials is possible , but the process of ethical approval and data collection is a lengthy one .
-CONCLUSIONS	To minimise many of the logistical problems , long-term follow-up of patients should be an integral part of future clinical trials .
-CONCLUSIONS	Moreover , regulations governing medical ethical approval for clinical research within the EU should be carefully evaluated to facilitate long-term follow-up of cancer survivors in Europe .
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-###25339155
-BACKGROUND	The serum collection under the abdominal flap is the most common complication after a lipo-abdominoplasty .
-BACKGROUND	The frequency of seroma increases further among obese patients , who have achieved massive weight loss after bariatric surgery .
-BACKGROUND	The purpose of this study is to demonstrate the effectiveness of fibrin glues with a low concentration of thrombin in reducing seroma formation after a lipo-abdominoplasty .
-METHODS	Thirty patients , that had achieved a significant weight loss after an intervention of laparoscopic adjustable gastric banding ( LAGB ) , underwent a circular lipo-abdominoplasty at our bariatric surgery department .
-METHODS	Patients were divided into two groups of 15 subjects each : group A underwent traditional surgery ; in group B , we applied a slow-clotting variant of fibrin glue ( ARTISS , Baxter ) under the abdominal flap .
-METHODS	All subjects were evaluated clinically using an ultrasound device on postoperative day 15 .
-METHODS	We considered positive for seroma , those cases with a liquid collection greater than 20 cc .
-RESULTS	The groups were homogeneous for age , BMI , male/female ratio , and diabetic or smoker patients .
-RESULTS	The mean hospital stay was significantly longer in group A than in group B.
-RESULTS	We found eight cases of serum collection > 20 cc in group A and only one case in group B. Hematoma , umbilicus necrosis , and surgical site infection occurred in both groups , but overall complication rate was lower in group B.
-CONCLUSIONS	The use of a fibrin glue with a low concentration of thrombin could be useful during wound closure and may decrease seroma formation in postbariatric patients undergoing lipo-abdominoplasty .
-
-###24548796
-BACKGROUND	Children with pulmonary hypertension routinely undergo pulmonary vascular resistance studies to assess the disease severity and vasodilator responsiveness .
-BACKGROUND	It is vital that results are accurate and reliable and are not influenced by the choice of anaesthetic agent .
-BACKGROUND	However , there are anecdotal data to suggest that propofol and inhalational agents have different effects on pulmonary vascular resistance .
-METHODS	A total of 10 children with pulmonary hypertension were selected sequentially to be included in the study .
-METHODS	To avoid confounding because of baseline anatomic or demographic details , a crossover protocol was implemented , using propofol or isoflurane , with time for washout in between each agent and blinding of the interventionalist .
-RESULTS	Pulmonary and systemic vascular resistance were not significantly different when using propofol or isoflurane .
-RESULTS	However , the calculated resistance fraction - ratio of pulmonary resistance to systemic resistance - was significantly lower when using propofol than when using isoflurane .
-CONCLUSIONS	Although no difference in pulmonary vascular resistance was demonstrated , this pilot study suggests that the choice of anaesthetic agent may affect the calculation of relative pulmonary and systemic vascular resistance , and provides some preliminary evidence to favour propofol over isoflurane .
-CONCLUSIONS	These findings require replication in a larger study , and thus they should be considered in future calculations to make informed decisions about the management of children with pulmonary hypertension .
-
-###25069770
-BACKGROUND	Dirofilaria repens is the causative agent of subcutaneous dirofilariosis of dogs , other animals and humans .
-BACKGROUND	This nematode is transmitted by mosquitoes of Aedes , Anopheles and Culex genera .
-BACKGROUND	In dogs , the parasite may cause subclinical infection or cutaneous signs .
-BACKGROUND	Recently , D. repens has emerged and spread in different geographical areas , with an increase of cases in dogs and humans .
-BACKGROUND	Chemoprevention in dogs in endemic areas is the most reliable approach for controlling this infection .
-BACKGROUND	This paper describes a randomized , blocked and multicentric clinical field study investigating the efficacy of an oral , chewable formulation containing milbemycin oxime/praziquantel ( Milbemax , Novartis Animal Health ) in the chemoprevention of subcutaneous dirofilariosis in dogs .
-METHODS	This study was conducted in endemic areas of Italy .
-METHODS	A total of 249 dogs , at two sites , negative for D. repens , were allocated into two groups ( i.e. Treated - T1 vs Untreated-T2 ) with a ratio of 1:1 , and subjected to clinical visits and blood sampling once monthly until the end of the study .
-METHODS	All blood samples were microscopically and genetically examined .
-METHODS	Animals belonging to T1 group received a minimum target dose of 0.5 mg/kg bodyweight of milbemycin oxime and 5 mg/kg of praziquantel in commercial tablets ( Milbemax ) according body weight once every 4 weeks .
-METHODS	Animals of group T2 were not treated with Milbemax but received , when necessary , specific parasiticide treatments .
-METHODS	The study duration was 336 2 days for each dog .
-RESULTS	A total of 219 dogs completed the study ( i.e. 111 in T1 and 108 in T2 ) , while 30 dogs ( i.e. 13 in T1 , 17 in T2 ) were withdrawn for a variety of reasons unrelated to administration of Milbemax .
-RESULTS	The percentages of animals not showing microfilariae of D. repens were 100 % ( 111 animals ) in T1 and 94.7 % ( 108 animals out of 114 ) in group T2 .
-RESULTS	Milbemax was shown to be safe in treated dogs .
-CONCLUSIONS	The results of this study confirm that the monthly use of Milbemax in dogs is effective and safe for the prevention of subcutaneous dirofilariosis in endemic areas .
-
-###24651243
-BACKGROUND	We investigated whether medial cord stimulation is inferior to posterior cord stimulation for vertical infraclavicular block with respect to block success .
-METHODS	Ninety-six patients scheduled for upper limb surgery were randomly elicited a medial or posterior cord response for infraclavicular block using 40 mL of 0.5 % ropivacaine .
-METHODS	We assessed block success ( complete sensory block of the 5 nerves in the forearm at 50 minutes ) as the primary end point and block procedure characteristics and adverse events as secondary end points .
-RESULTS	The block success rates did not differ significantly between medial and posterior cord stimulation ( 95.7 % [ 44/46 ] vs 91.7 % [ 44/48 ] , 95 % CI of difference , -7.4 % to 15.6 % ) , while the secondary end points were comparable in both groups .
-CONCLUSIONS	Needle manipulation to elicit medial cord response is noninferior to posterior cord response of block success during neurostimulation-guided vertical infraclavicular block .
-
-###25117066
-BACKGROUND	Pharmacokinetically guided ( PK-guided ) versus body surface area-based 5-fluorouracil ( 5-FU ) dosing results in higher response rates and better tolerability .
-BACKGROUND	A paucity of data exists on PK-guided 5-FU dosing in the community setting .
-METHODS	Seventy colorectal cancer patients , from one academic and five community cancer centers , received the mFOLFOX6 regimen ( 5-FU 2,400 mg/m ( 2 ) over 46 hours every 2 weeks ) with or without bevacizumab at cycle 1 .
-METHODS	The 5-FU continuous-infusion dose was adjusted for cycles 2-4 using a PK-guided algorithm to achieve a literature-based target area under the concentration-time curve ( AUC ) .
-METHODS	The primary objective was to demonstrate that PK-guided 5-FU dosing improves the ability to achieve a target AUC within four cycles of therapy .
-METHODS	The secondary objective was to demonstrate reduced incidence of 5-FU-related toxicities .
-RESULTS	At cycles 1 and 4 , 27.7 % and 46.8 % of patients achieved the target AUC ( 20-25 mg hour/L ) , respectively ( odds ratio [ OR ] : 2.20 ; p = .046 ) .
-RESULTS	Significantly more patients were within range at cycle 4 compared with a literature rate of 20 % ( p < .0001 ) .
-RESULTS	Patients had significantly higher odds of not being underdosed at cycle 4 versus cycle 1 ( OR : 2.29 ; p = .037 ) .
-RESULTS	The odds of a patient being within range increased by 30 % at each subsequent cycle ( OR : 1.30 ; p = .03 ) .
-RESULTS	Less grade 3/4 mucositis and diarrhea were observed compared with historical data ( 1.9 % vs 16 % and 5.6 % vs 12 % , respectively ) ; however , rates of grade 3/4 neutropenia were similar ( 33 % vs 25 % -50 % ) .
-CONCLUSIONS	PK-guided 5-FU dosing resulted in significantly fewer underdosed patients and less gastrointestinal toxicity and allows for the application of personalized colorectal cancer therapy in the community setting .
-
-###24815101
-OBJECTIVE	To assess the side effects unrelated to disease activity and the acceptability of combined oral contraceptives ( COCs ) , progestin-only pills ( POPs ) and copper-releasing intrauterine devices ( IUDs ) in women with systemic lupus erythematosus ( SLE ) .
-METHODS	A randomized clinical trial including 162 women with SLE , assigned to COC ( n = 54 ) , POP ( n = 54 ) or IUD ( n = 54 ) .
-METHODS	Follow-up visits were conducted after 1 , 2 , 3 , 6 , 9 and 12 months of treatment to monitor the presence of symptoms , changes in body weight and blood pressure as well as the development of health problems other than those relating to lupus .
-METHODS	Reasons for discontinuation and satisfaction with the use of the assigned method were recorded at the end of treatment .
-METHODS	Statistical analysis included descriptive statistics , repeated measure analyses and Kaplan-Meier curves .
-RESULTS	Significantly different discontinuation rates due to any reason [ 35 % , 55 % , 29 % ( p < 0.01 ) ] or nonmedical reasons [ ( 11 % , 31 % , 4 % ( p < 0.05 ) ] were observed among the COC , POP and IUD groups .
-RESULTS	Nausea was most frequent among COC users , dysmenorrhea among IUD users and acne and hirsutism among POP users .
-RESULTS	Mean blood pressures remained unchanged .
-RESULTS	Mild increases in body weight were observed over time in all treatment groups .
-RESULTS	Most women were satisfied with the use of the assigned contraceptive method .
-CONCLUSIONS	Oral contraceptives and IUD are acceptable birth control methods for patients with lupus , when counseling and specialized health attention are provided ; however , the acceptability of POP appears to be inferior .
-CONCLUSIONS	Side effects unrelated to lupus disease activity are not frequent reasons to discontinue the contraceptive methods .
-CONCLUSIONS	This study delves into an area that has not been explored among patients with lupus .
-CONCLUSIONS	Our findings on the associated side effects and reasons for discontinuing COCs , POPs or copper-bearing IUDs may be useful in improving contraceptive counseling for women with lupus .
-CONCLUSIONS	Furthermore , they also heighten our knowledge on the reasons that may preclude the widespread use of effective contraceptives among lupus patients .
-
-###24684165
-BACKGROUND	Post-inflammatory hyperpigmentation is a frequent concern when treating solar lentigines .
-OBJECTIVE	To assess the safety and efficacy of a triple combination cream with fluocinolone acetonide 0.01 % , hydroquinone 4 % and tretinoin 0.05 % as adjuvant to cryotherapy in the treatment of solar lentigines in hands dorsum , and in the prevention of post-inflammatory hyperpigmentation after cryotherapy .
-METHODS	This prospective , randomized , controlled , investigator-blinded , single-centre study enrolled 50 patients .
-METHODS	Twenty-five patients received a 2-week daily triple combination cream plus sunscreen pre-treatment and 25 received sunscreen alone .
-METHODS	After that , cryotherapy was performed in all patients followed by a 3-week recovery period .
-METHODS	After this period , patients received the same initial treatment and were followed up for 8weeks .
-METHODS	Melanin and erythema levels of a target and a control lentigo were objectively measured using a narrowband reflectance spectrophotometer .
-METHODS	Lentigines count , colour homogeneity and global improvement were also assessed .
-RESULTS	The number of solar lentigines reduced in the first 2weeks only in patients who used the triple combination 257 vs. 228 ( P < 0.0001 ) , and reduced at the end of the study for both groups ( P < 0.0001 ) .
-RESULTS	The melanin levels also reduced in the first 2weeks only in patients who used the triple combination 29769 vs. 27366 ( P < 0.0001 ) and reduced at the end of the study for both groups ( P < 0.0001 ) .
-RESULTS	Erythema and residual blisters from cryotherapy were the reported adverse reactions .
-CONCLUSIONS	Triple combination cream can be used to enhance the resolution of solar lentigines , and to significantly reduce melanin levels and lentigines count , improving treatment results .
-CONCLUSIONS	It was well-tolerated and did not increase the occurrence of neither erythema nor other side-effects after the cryotherapy .
-
-###25053749
-OBJECTIVE	The purpose of this article is to investigate the efficacy and safety of frovatriptan plus dexketoprofen 25 or 37.5 mg ( FroDex25 or FroDex37 .5 , respectively ) compared to that of frovatriptan 2.5 mg ( Frova ) in menstrually related migraine ( MRM ) .
-OBJECTIVE	The aim of this article is to analyze a subgroup of 76 women who treated an MRM attack in this multicenter , randomized , double-blind , parallel-group study .
-METHODS	The primary end-point was the proportion of patients who were pain free ( PF ) at two hours .
-METHODS	Secondary end-points included pain-relief ( PR ) at two hours and 48 hours sustained pain free ( SPF ) .
-RESULTS	PF rates at two hours were 29 % under Frova , 48 % under FroDex25 and 64 % under FroDex37 .5 ( p < 0.05 ) .
-RESULTS	PR at two hours was Frova 52 % , FroDex25 81 % and FroDex37 .5 88 % , while 48 hours SPF was 18 % under Frova , 30 % under FroDex25 and 44 % under FroDex37 .5 .
-CONCLUSIONS	Combining frovatriptan + dexketoprofen produced higher PF rates at two hours compared to Frova while maintaining efficacy at 48 hours .
-CONCLUSIONS	Tolerability profiles were comparable .
-
-###25667975
-OBJECTIVE	Triage of HPV screen-positive women is needed to identify those with underlying cervical intraepithelial neoplasia grade 2/3 or worse ( CIN2/3 + ) .
-OBJECTIVE	Presently , cytology on a physician-taken cervical scrape is mostly accepted as triage test , but needs follow-up testing in order not to miss severe disease .
-OBJECTIVE	Here , we evaluated the performance of combined cytology and bi-marker CADM1/MAL-methylation analysis as triage test on physician-taken cervical scrapes of HPV positive women .
-METHODS	In this post-hoc analysis , we used 364 left-over HPV positive cytology triage samples of participants of a randomized controlled trial ( PROHTECT-3 : n = 46,001 ) performed in population-based cervical screening .
-METHODS	Study endpoints were CIN2 + and CIN3 + detection .
-METHODS	Cytology testing with and without methylation marker analysis was evaluated with regard to sensitivity , specificity , positive and negative predictive value , and referral rate .
-RESULTS	Bi-marker CADM1/MAL-methylation positivity increased proportionally with severity of underlying lesions .
-RESULTS	Overall , cytology and bi-marker CADM1/MAL-methylation analysis yielded similar performances with regard to CIN3 + detection , yet in combination a significantly higher sensitivity for CIN3 + ( 88.7 % ) was obtained at a specificity of 53.6 % and a colposcopy referral rate of 53.6 % .
-RESULTS	The combined strategy detected all six cervical cancers , whereas triage by cytology alone failed to detect two of them .
-CONCLUSIONS	Cytology and bi-marker CADM1/MAL-methylation analysis perform complementary for CIN2 + / CIN3 + detection when used as triage tool on cervical scrapes of HPV positive women .
-CONCLUSIONS	This approach not only results in a higher CIN3 + sensitivity than cytology triage with an acceptable referral rate , but also seems to reduce the risk of missing cervical cancers and advanced high-grade lesions .
-
-###25347623
-BACKGROUND	The analgesic efficacy of the transversus abdominis plane peripheral nerve block following abdominal tissue breast reconstruction has not been studied in a randomized controlled trial .
-METHODS	The authors conducted a double-blind , placebo-controlled , 1:1 allocation , two-arm parallel group , superiority design , randomized controlled trial in patients undergoing microsurgical abdominally based breast reconstruction .
-METHODS	Intraoperatively , epidural catheters were inserted under direct vision through the triangle of Petit on both sides of the abdomen into the transversus abdominis plane just before rectus fascial closure .
-METHODS	Patients received either bupivacaine ( study group ) or saline ( placebo group ) through the catheters for 2 postoperative days .
-METHODS	All patients received hydromorphone by means of a patient-controlled analgesic pump .
-METHODS	The primary outcome was the difference in the parenteral opioid consumption on each postoperative day between the groups .
-METHODS	The secondary outcome measures included the following : total in-hospital opioid ; antinausea medication ; pain , nausea , and sedation scores ; Quality of Recovery Score ; time to ambulation ; and hospital stay duration .
-RESULTS	Between September of 2011 and June of 2013 , 93 patients were enrolled : 49 received bupivacaine and 44 received saline .
-RESULTS	There were 11 postoperative complications ( 13 percent ) ; none were related to the catheter .
-RESULTS	Primary outcomes were completed by 85 of 93 patients ( 91.3 percent ) ; the mean parenteral morphine consumption was significantly reduced on postoperative day 1 in the bupivacaine group ( 20.720.1 mg ) compared with 30.019.1 mg in the control group ( p = 0.02 ) .
-RESULTS	There were no significant differences in secondary outcomes .
-CONCLUSIONS	Following abdominally based breast reconstruction , transversus abdominis plane peripheral nerve block is safe and significantly reduces morphine consumption in the early postoperative period .
-METHODS	Therapeutic , II .
-
-###25436350
-OBJECTIVE	The aim of this study was to comparatively examine the convenience of use of the QUEST and GerdQ questionnaires as self-administered diagnostic instruments .
-METHODS	This was a two-way crossover study conducted from December 2011 to April 2012 .
-METHODS	The subjects were 70 third-year nursing students of Yokohama Soei University in Yokohama , Japan .
-METHODS	They were randomly assigned to fill in either of the study questionnaires first , and then the other on a later .
-RESULTS	A significant difference was observed in the questionnaire completion time between the QUEST and GerdQ questionnaires ( 125.5 vs. 44 seconds , P < 0.0001 ) and also in the number of subjects asking questions while completing the questionnaires ( 26 vs. 1 subject , respectively : P < 0.0001 ) .
-RESULTS	To detect GERD based on a QUEST score of 4 , ROC analysis revealed an area under the curve for the GerdQ score of 0.616 .
-RESULTS	The optimal cutoff value of the GerdQ score was 6 , and the sensitivity and specificity calculated using this cutoff value were 0.842 and 0.312 , respectively .
-CONCLUSIONS	This study revealed that Japanese subjects may find it easier to complete the GerdQ than the QUEST questionnaire .
-
-###24756128
-OBJECTIVE	Prevention of iron deficiency in infancy may promote neurodevelopment .
-OBJECTIVE	Delayed cord clamping ( DCC ) can prevent iron deficiency during the first 6 months of life .
-OBJECTIVE	However , no data are available on long-term effects on infant outcomes in relation to time for umbilical cord clamping .
-OBJECTIVE	To investigate effects of DCC , as compared with early cord clamping ( ECC ) , on infant iron status and neurodevelopment at age 12 months in a European setting .
-METHODS	Randomized clinical trial of 382 full-term infants born after a low-risk pregnancy at a Swedish county hospital .
-METHODS	Follow-up at 12 months included evaluation of iron status ( ferritin level , transferrin saturation , transferrin receptor level , reticulocyte hemoglobin level , and mean cell volume ) and parental assessment of neurodevelopment by the Ages and Stages Questionnaire , second edition ( ASQ ) .
-METHODS	Infants were randomized to DCC ( 180 seconds after delivery ) or ECC ( 10 seconds after delivery ) .
-METHODS	The main outcome was iron status at age 12 months ; the secondary outcome was ASQ score .
-RESULTS	In total , 347 of 382 infants ( 90.8 % ) were assessed .
-RESULTS	The DCC and ECC groups did not differ in iron status ( mean ferritin level , 35.4 vs 33.6 ng/mL , respectively ; P = .40 ) or neurodevelopment ( mean ASQ total score , 229.6 vs 233.1 , respectively ; P = .42 ) at age 12 months .
-RESULTS	Predictors of ferritin levels were infant sex and ferritin in umbilical cord blood .
-RESULTS	Predictors of ASQ score were infant sex and breastfeeding within 1 hour after birth .
-RESULTS	For both outcomes , being a boy was associated with lower results .
-RESULTS	Interaction analysis showed that DCC was associated with an ASQ score 5 points higher among boys ( mean [ SD ] score , 229 [ 43 ] for DCC vs 224 [ 39 ] for ECC ) but 12 points lower among girls ( mean [ SD ] score , 230 [ 39 ] for DCC vs 242 [ 36 ] for ECC ) , out of a maximum of 300 points ( P = .04 for the interaction term ) .
-CONCLUSIONS	Delayed cord clamping did not affect iron status or neurodevelopment at age 12 months in a selected population of healthy term-born infants .
-CONCLUSIONS	However , it may not be possible to demonstrate minor effects on neurodevelopment with the size of the study population and the chosen method for assessment .
-CONCLUSIONS	The current data indicate that sex may influence the effects on infant development after DCC in different directions .
-CONCLUSIONS	The magnitude and biological reason for this finding remain to be investigated .
-CONCLUSIONS	TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT01245296 .
-
-###25439692
-BACKGROUND	Dacomitinib is an irreversible pan-HER tyrosine-kinase inhibitor with preclinical and clinical evidence of activity in non-small-cell lung cancer .
-BACKGROUND	We designed BR .26 to assess whether dacomitinib improved overall survival in heavily pretreated patients with this disease .
-METHODS	In this double-blind , randomised , placebo-controlled , phase 3 trial , we enrolled adults ( aged 18 years ) with advanced or metastatic non-small-cell lung cancer from 75 centres in 12 countries .
-METHODS	Eligible patients had received up to three previous lines of chemotherapy and either gefitinib or erlotinib , and had assessable disease ( RECIST 1.1 ) and tumour tissue samples for translational studies .
-METHODS	Patients were stratified according to centre , performance status , tobacco use , best response to previous EGFR tyrosine-kinase inhibitor , weight loss within the previous 3 months , and ethnicity , and were then randomly allocated 2:1 to oral dacomitinib 45 mg once-daily or matched placebo centrally via a web-based system .
-METHODS	Treatment continued until disease progression or unacceptable toxicity .
-METHODS	The primary outcome was overall survival in the intention-to-treat population ; secondary outcomes included overall survival in predefined molecular subgroups , progression-free survival , the proportion of patients who achieved an objective response , safety , and quality of life .
-METHODS	This study is completed , although follow-up is ongoing for patients on treatment .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT01000025 .
-RESULTS	Between Dec 23 , 2009 , and June 11 , 2013 , we randomly assigned 480 patients to dacomitinib and 240 patients to placebo .
-RESULTS	At the final analysis ( January , 2014 ) , median follow-up was 234 months ( IQR 156-296 ) for patients in the dacomitinib group and 244 months ( 115-389 ) for those in the placebo group .
-RESULTS	Dacomitinib did not improve overall survival compared with placebo ( median 683 months [ 95 % CI 608-749 ] for dacomitinib vs 631 months [ 532-752 ] for placebo ; hazard ratio [ HR ] 100 [ 95 % CI 083-121 ] ; p = 0506 ) .
-RESULTS	However , patients in the dacomitinib group had longer progression-free survival than those in the placebo group ( median 266 months [ 191-332 ] vs 138 months [ 099-174 ] , respectively ; HR 066 [ 95 % CI 055-079 ] ; p < 00001 ) , and a significantly greater proportion of patients in the dacomitinb group achieved an objective response than in the placebo group ( 34 [ 7 % ] of 480 patients vs three [ 1 % ] of 240 patients , respectively ; p = 0001 ) .
-RESULTS	Compared with placebo , the effect of dacomitinib on overall survival seemed similar in patients with EGFR-mutation-positive tumours ( HR 098 , 95 % CI 067-144 ) and EGFR wild-type tumours ( 093 , 071-121 ; pinteraction = 069 ) .
-RESULTS	However , we noted qualitative differences in the effect of dacomitinib on overall survival for patients with KRAS-mutation-positive tumours ( 210 , 105-422 ) and patients with KRAS wild-type tumours ( 079 , 061-103 ; pinteraction = 008 ) .
-RESULTS	Compared with placebo , patients allocated dacomitinib had significantly longer time to deterioration of cough ( p < 00001 ) , dyspnoea ( p = 0049 ) , and pain ( p = 0041 ) .
-RESULTS	185 ( 39 % ) of 477 patients who received dacomitinib and 86 ( 36 % ) of 239 patients who received placebo had serious adverse events .
-RESULTS	The most common grade 3-4 adverse events were diarrhoea ( 59 [ 12 % ] patients on dacomitinib vs no controls ) , acneiform rash ( 48 [ 10 % ] vs one [ < 1 % ] ) , oral mucositis ( 16 [ 3 % ] vs none ) , and fatigue ( 13 [ 3 % ] vs four [ 2 % ] ) .
-CONCLUSIONS	Dacomitinib did not increase overall survival and can not be recommended for treatment of patients with advanced non-small-cell lung cancer previously treated with chemotherapy and an EGFR tyrosine-kinase inhibitor .
-BACKGROUND	Canadian Cancer Society Research Institute and Pfizer .
-
-###24333184
-OBJECTIVE	Treatment for CH-C contains interferon with substantial associated side effects and health-related quality of life ( HRQL ) impairment .
-OBJECTIVE	Currently , there is no published data assessing the impact of interferon-free regimens on HRQL .
-OBJECTIVE	The aim is to report the HRQL of patients who participated in clinical trials of sofosbuvir ( SOF ) for CH-C .
-METHODS	CH-C patients were treated with sofosbuvir ( SOF ) , pegylated interferon ( PegIFN ) , ribavirin ( RBV ) , or placebo in different combinations and duration ( POSITRON , FISSION , FUSION , and NEUTRINO phase III trials ) .
-METHODS	HRQL was assessed using SF-36 at baseline , during treatment , at the end of treatment , and at follow-up , and compared between treatment arms .
-RESULTS	HRQL scores decreased over the course of treatment for all treatment arms in all studies ; however , patients returned to their baseline score by the end of follow-up .
-RESULTS	Compared to placebo , SOF and RBV was not associated with HRQL impairment ( POSITRON ) .
-RESULTS	Compared to SOF and RBV , HRQL was significantly more impaired in the PegIFN and RBV arm ( FISSION ) .
-RESULTS	For those treated with SOF and RBV , there was no difference in HRQL between 12 weeks or 16 weeks of treatment ( FUSION ) .
-RESULTS	Multivariate analysis demonstrated that depression , fatigue , and insomnia were important predictors of patients ' HRQL prior , during or after treatment .
-RESULTS	Additionally , anemia and receiving interferon were predictors of HRQL impairment during treatment .
-RESULTS	Achieving sustained virologic response after 12 weeks of follow-up ( SVR-12 ) with SOF and RBV was associated with improvement in HRQL scores from baseline .
-CONCLUSIONS	Treatment-related HRQL impairment during SOF and RBV regimen is mild , and does not increase with longer treatment duration .
-CONCLUSIONS	Achieving SVR-12 with SOF and RBV is associated with an improvement in HRQL .
-
-###24866985
-BACKGROUND	Fetal Alcohol Spectrum Disorders ( FASDs ) are the leading known preventable birth defects in North America .
-BACKGROUND	Knowledge surveys about FASD have been conducted with various health and allied healthcare providers and have proven useful in identifying gaps in knowledge and differences among provider groups to support prevention efforts .
-BACKGROUND	To date , no research has been conducted exploring FASD knowledge among college students .
-OBJECTIVE	This study explored FASD knowledge in a sample of college students , a group at particularly high risk for alcohol-exposed pregnancies .
-OBJECTIVE	Findings are compared to professionals in several healthcare and affiliated professional groups who were previously surveyed with the same FASD-related items .
-METHODS	Surveys from 1,035 college students at a northwestern university were analyzed .
-METHODS	Included with the ACHA-National College Health Assessment II were questions regarding FASD .
-METHODS	College students ' knowledge was compared with that of professionals in key healthcare and affiliated positions to define their relative awareness of FASD risk .
-RESULTS	Overall , findings revealed adequate FASD knowledge among college students .
-RESULTS	Although minor differences emerged when comparing students and professionals ' responses , most respondent groups answered with an 85 % accuracy rate or higher .
-CONCLUSIONS	College students demonstrated adequate knowledgeable about FASD .
-CONCLUSIONS	Future research must explore whether such knowledge translates into lower risk behavior and consequent reduction in alcohol-exposed pregnancies .
-
-###25140931
-BACKGROUND	High - and low-frequency repetitive transcranial magnetic stimulation ( HF-rTMS and LF-rTMS ) has been shown to be beneficial for upper limb hemiparesis in patients with acute stroke .
-BACKGROUND	However , no study has examined the usefulness of bilateral application of HF - and LF-rTMS ( BL-rTMS ) .
-METHODS	Fifty-eight hemiparetic patients with acute stroke were randomly assigned into two groups : HF-rTMS group and BL-rTMS group .
-METHODS	All patients were scheduled to receive five sessions of either HF-rTMS over the lesional hemisphere or BL-rTMS over both hemispheres for 5 days .
-METHODS	Motor function of the affected upper limb was evaluated using the Brunnstrom Recovery Stage ( BRS ) for upper-limb and hand-fingers , grip strength and tapping frequency , before the first session and after the last session of rTMS .
-RESULTS	Improvement of BRS for the upper limb and hand/finger was significantly greater in the BL-rTMS group than the HF-rTMS group ( p < 0.01 ) .
-RESULTS	Improvement in grip strength and tapping frequency was also greater in the BL-rTMS group , although the differences were not statistically significant .
-CONCLUSIONS	The proposed BL-rTMS is safe and feasible and showed a greater improvement of BRS of the affected upper limb compared to HF-rTMS .
-CONCLUSIONS	This novel rTMS approach may be a useful intervention for hemiparetic patients with acute stroke .
-
-###24997003
-BACKGROUND	The evaluation of intestinal trophism , mainly the mucosal layer , is an important issue in various conditions associated with injury , atrophy , recovery , and healing of the gut .
-BACKGROUND	The aim of the present study was to evaluate the kinetics of the proliferation and apoptosis of enterocytes by immunohistochemistry and to assess the complexity of intestinal mucosa by fractal dimension ( FD ) analysis in Solea solea fed different experimental diets .
-RESULTS	Histomorphological evaluation of all intestinal segments did not show signs of degeneration or inflammation .
-RESULTS	Cell proliferation index and FD were significantly reduced with a diet high in mussel meal ( MM ; p = 0.0034 and p = 0.01063 , respectively ) , while apoptotic index did not show any significant difference for the same comparison ( p = 0.3859 ) .
-RESULTS	Linear regression analysis between apoptotic index ( independent variable ) and FD ( dependent variable ) showed a statistically significant inverse relationship ( p = 0.002528 ) .
-RESULTS	Linear regression analysis between cell proliferation index ( independent variable ) and FD ( dependent variable ) did not show any significant correlation ( p = 0.131582 ) .
-CONCLUSIONS	The results demonstrated that diets containing increasing levels of mussel meal in substitution of fishmeal did not incite a hyperplastic response of the intestinal mucosa .
-CONCLUSIONS	The mussel meal , which is derived from molluscs , could mimic the characteristics of the sole 's natural prey , being readily digestible , even without increasing the absorptive surface of intestinal mucosa .
-CONCLUSIONS	Interestingly , from this study emerged that FD could be used as a numeric indicator complementary to in situ quantification methods to measure intestinal trophism , in conjunction with functional parameters .
-
-###25970252
-OBJECTIVE	It is unclear whether d-cycloserine ( DCS ) , a partial N-methyl-d-aspartate agonist that enhances fear extinction , can augment the effects of exposure-based cognitive behavioral therapy ( CBT ) for obsessive-compulsive disorder ( OCD ) .
-OBJECTIVE	To examine whether DCS augments the effects of CBT for OCD and to explore ( post hoc ) whether concomitant antidepressant medication moderates the effects of DCS .
-METHODS	A 12-week , double-blind randomized clinical trial with 3-month follow-up conducted at an academic medical center between September 4 , 2012 , and September 26 , 2013 .
-METHODS	Participants included 128 adult outpatients with a primary diagnosis of OCD and a Yale-Brown Obsessive Compulsive Scale ( Y-BOCS ) score of 16 or higher .
-METHODS	Concurrent antidepressant medication was permitted if the dose had been stable for at least 2 months prior to enrollment and remained unchanged during the trial .
-METHODS	The main analysis was by intention-to-treat population .
-METHODS	All participants received a previously validated Internet-based CBT protocol over 12 weeks and were randomized to receive either 50 mg of DCS or placebo , administered 1 hour before each of 5 exposure and response prevention tasks .
-METHODS	Clinician-administered Y-BOCS score at week 12 and at 3-month follow-up .
-METHODS	Remission was defined as a score of 12 or lower on the Y-BOCS .
-RESULTS	In the primary intention-to-treat analyses , DCS did not augment the effects of CBT compared with placebo ( mean [ SD ] clinician-rated Y-BOCS score , DCS : 13.86 [ 6.50 ] at week 12 and 12.35 [ 7.75 ] at 3-month follow-up ; placebo : 11.77 [ 5.95 ] at week 12 and 12.37 [ 6.68 ] at 3-month follow-up ) but showed a significant interaction with antidepressants ( clinician-rated Y-BOCS , B = -1.08 ; Z = -2.79 ; P = .005 ) .
-RESULTS	Post hoc analyses revealed that antidepressants significantly impaired treatment response in the DCS group but not the placebo group , at both posttreatment and follow-up ( clinician-rated Y-BOCS : t62 = -3.00 ; P = .004 ; and t61 = -3.49 ; P < .001 , respectively ) .
-RESULTS	In the DCS group , a significantly greater proportion of antidepressant-free patients achieved remission status at follow-up ( 60 % [ 95 % CI , 45 % -74 % ] ) than antidepressant-medicated patients ( 24 % [ 95 % CI , 9 % -48 % ] ) ( P = .008 ) .
-RESULTS	Antidepressants had no effect in the placebo group ( 50 % [ 95 % CI , 36 % -64 % ] remission rate in both groups ) .
-CONCLUSIONS	The findings suggest that antidepressants may interact with DCS to block its facilitating effect on fear extinction .
-CONCLUSIONS	Use of DCS may be a promising CBT augmentation strategy but only in antidepressant-free patients with OCD .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01649895 .
-
-###24666826
-BACKGROUND	Acute heart failure ( AHF ) is characterized by inadequate cardiac output ( CO ) , congestive symptoms , poor peripheral perfusion and end-organ dysfunction .
-BACKGROUND	Treatment often includes a combination of diuretics , oxygen , positive pressure ventilation , inotropes and vasodilators or vasopressors .
-BACKGROUND	Lactate is a marker of illness severity but is also an important metabolic substrate for the myocardium at rest and during stress .
-BACKGROUND	We tested the effects of half-molar sodium lactate infusion on cardiac performance in AHF .
-METHODS	We conducted a prospective , randomised , controlled , open-label , pilot clinical trial in 40 patients fulfilling two of the following three criteria for AHF : ( 1 ) left ventricular ejection fraction < 40 % , ( 2 ) acute pulmonary oedema or respiratory failure of predominantly cardiac origin requiring mechanical ventilation and ( 3 ) currently receiving vasopressor and/or inotropic support .
-METHODS	Patients in the intervention group received a 3 ml/kg bolus of half-molar sodium lactate over the course of 15 minutes followed by 1 ml/kg/h continuous infusion for 24 hours .
-METHODS	The control group received only a 3 ml/kg bolus of Hartmann 's solution without continuous infusion .
-METHODS	The primary outcome was CO assessed by transthoracic echocardiography 24 hours after randomisation .
-METHODS	Secondary outcomes included a measure of right ventricular systolic function ( tricuspid annular plane systolic excursion ( TAPSE ) ) , acid-base balance , electrolyte and organ function parameters , along with length of stay and mortality .
-RESULTS	The infusion of half-molar sodium lactate increased ( meanSD ) CO from 4.051.37 L/min to 5.491.9 L/min ( P < 0.01 ) and TAPSE from 14.75.5 mm to 18.37 mm ( P = 0.02 ) .
-RESULTS	Plasma sodium and pH increased ( 1364 to 1466 and 7.400.06 to 7.530.03 , respectively ; both P < 0.01 ) , but potassium , chloride and phosphate levels decreased .
-RESULTS	There were no significant differences in the need for vasoactive therapy , respiratory support , renal or liver function tests , duration of ICU and hospital stay or 28 - and 90-day mortality .
-CONCLUSIONS	Infusion of half-molar sodium lactate improved cardiac performance and led to metabolic alkalosis in AHF patients without any detrimental effects on organ function .
-BACKGROUND	Clinicaltrials.gov NCT01981655 .
-BACKGROUND	Registered 13 August 2013 .
-
-###25482425
-BACKGROUND	Experimental data indicate that reducing factor XI levels attenuates thrombosis without causing bleeding , but the role of factor XI in the prevention of postoperative venous thrombosis in humans is unknown .
-BACKGROUND	FXI-ASO ( ISIS 416858 ) is a second-generation antisense oligonucleotide that specifically reduces factor XI levels .
-BACKGROUND	We compared the efficacy and safety of FXI-ASO with those of enoxaparin in patients undergoing total knee arthroplasty .
-METHODS	In this open-label , parallel-group study , we randomly assigned 300 patients who were undergoing elective primary unilateral total knee arthroplasty to receive one of two doses of FXI-ASO ( 200 mg or 300 mg ) or 40 mg of enoxaparin once daily .
-METHODS	The primary efficacy outcome was the incidence of venous thromboembolism ( assessed by mandatory bilateral venography or report of symptomatic events ) .
-METHODS	The principal safety outcome was major or clinically relevant nonmajor bleeding .
-RESULTS	Around the time of surgery , the mean ( SE ) factor XI levels were 0.380.01 units per milliliter in the 200-mg FXI-ASO group , 0.200.01 units per milliliter in the 300-mg FXI-ASO group , and 0.930.02 units per milliliter in the enoxaparin group .
-RESULTS	The primary efficacy outcome occurred in 36 of 134 patients ( 27 % ) who received the 200-mg dose of FXI-ASO and in 3 of 71 patients ( 4 % ) who received the 300-mg dose of FXI-ASO , as compared with 21 of 69 patients ( 30 % ) who received enoxaparin .
-RESULTS	The 200-mg regimen was noninferior , and the 300-mg regimen was superior , to enoxaparin ( P < 0.001 ) .
-RESULTS	Bleeding occurred in 3 % , 3 % , and 8 % of the patients in the three study groups , respectively .
-CONCLUSIONS	This study showed that factor XI contributes to postoperative venous thromboembolism ; reducing factor XI levels in patients undergoing elective primary unilateral total knee arthroplasty was an effective method for its prevention and appeared to be safe with respect to the risk of bleeding .
-CONCLUSIONS	( Funded by Isis Pharmaceuticals ; FXI-ASO TKA ClinicalTrials.gov number , NCT01713361 . )
-
-###24666696
-BACKGROUND	Inhalation of capsaicin , the extract of hot chili peppers , induces coughing in both animals and human subjects through activation of transient receptor potential vanilloid 1 ( TRPV1 ) on airway sensory nerves .
-BACKGROUND	Therefore the TRPV1 receptor is an attractive target for the development of antitussive agents .
-OBJECTIVE	We sought to assess the antitussive effect of TRPV1 antagonism in patients with refractory chronic cough .
-METHODS	Twenty-one subjects with refractory chronic cough ( > 8 weeks ) attending a specialist clinic were recruited to a randomized , double-blind , placebo-controlled crossover trial assessing a TRPV1 antagonist ( SB-705498 ) .
-METHODS	Cough reflex sensitivity to capsaicin ( concentration of capsaicin inducing at least 5 coughs ) and 24-hour cough frequency were coprimary end points assessed after a single dose of SB-705498 ( 600 mg ) and matched placebo .
-METHODS	Cough severity and urge to cough were reported on visual analog scales , and cough-specific quality of life data were also collected .
-RESULTS	Treatment with SB-705498 produced a significant improvement in cough reflex sensitivity to capsaicin at 2 hours and a borderline significant improvement at 24 hours compared with placebo ( adjusted mean difference of +1.3 doubling doses at 2 hours [ 95 % CI , +0.3 to +2.2 ; P = .0049 ] and +0.7 doubling doses at 24 hours [ 95 % CI , +0.0 to +1.5 ; P = .0259 ] ) .
-RESULTS	However , 24-hour objective cough frequency was not improved compared with placebo .
-RESULTS	Patient-reported cough severity , urge to cough , and cough-specific quality of life similarly suggested no effect of SB-705498 .
-CONCLUSIONS	This study raises important questions about both the role of TRVP1-mediated mechanisms in patients with refractory chronic cough and also the predictive value of capsaicin challenge testing in the assessment of novel antitussive agents .
-
-###24220704
-OBJECTIVE	To develop an optimal model and age-specific centiles for the decline in antimllerian hormone ( AMH ) as measured by the new Beckman Coulter AMH Generation II ( Gen II ) assay and compare this to the previous nomogram derived for the Diagnostics Systems Laboratory ( DSL ) assay .
-METHODS	Multicenter retrospective population study , with validation of linear , biphasic linear , differential , power , and quadratic equations .
-METHODS	Two clinical pathology laboratories .
-METHODS	A new cohort of 10,984 women aged 25 to 45 years old attending infertility clinics , randomly divided into a training cohort of 5,492 women and a validation cohort of 5,492 women , and an existing cohort of 9,601 women , who had contributed to the development and validation of a nomogram for AMH measured by the DSL assay .
-METHODS	Serum measurement of AMH as determined by the Beckman Coulter AMH Generation II assay in 10,984 women .
-METHODS	Optimal model for the decline in AMH as measured by the AMH Gen II assay with age , with age-specific 5th , 10th , 25th , 50th , 75th , 90th , and 95th percentiles .
-RESULTS	A quadratic model defined as ( 2.431 + 0.089 * Age + -0.003 * Age ( 2 ) ) fitted the decline in AMH with age .
-RESULTS	The anticipated 40 % increase in age-specific population values relative to the previously validated DSL assay nomogram was not observed .
-CONCLUSIONS	Age-specific reference ranges for the AMH gen II assay suggest a systematic shift in assay calibration since initial evaluation and commercial release of the AMH Gen II assay .
-
-###24886034
-BACKGROUND	Mild cognitive impairment ( MCI ) is a condition characterized by memory problems that are more severe than the normal cognitive changes due to aging , but less severe than dementia .
-BACKGROUND	Reduced working memory ( WM ) is regarded as one of the core symptoms of an MCI condition .
-BACKGROUND	Recent studies have indicated that WM can be improved through computer-based training .
-BACKGROUND	The objective of this study is to evaluate if WM training is effective in improving cognitive function in elderly patients with MCI , and if cognitive training induces structural changes in the white and gray matter of the brain , as assessed by structural MRI .
-METHODS	The proposed study is a blinded , randomized , controlled trail that will include 90 elderly patients diagnosed with MCI at a hospital-based memory clinic .
-METHODS	The participants will be randomized to either a training program or a placebo version of the program .
-METHODS	The intervention is computerized WM training performed for 45minutes of 25 sessions over 5weeks .
-METHODS	The placebo version is identical in duration but is non-adaptive in the difficulty level of the tasks .
-METHODS	Neuropsychological assessment and structural MRI will be performed before and 1 month after training , and at a 5-month folllow-up .
-CONCLUSIONS	If computer-based training results in positive changes to memory functions in patients with MCI this may represent a new , cost-effective treatment for MCI .
-CONCLUSIONS	Secondly , evaluation of any training-induced structural changes to gray or white matter will improve the current understanding of the mechanisms behind effective cognitive interventions in patients with MCI .
-BACKGROUND	ClinicalTrials.gov NCT01991405 .
-BACKGROUND	November 18 , 2013 .
-
-###24294837
-OBJECTIVE	We compared mindfulness-based cognitive therapy ( MBCT ) with both cognitive psychological education ( CPE ) and treatment as usual ( TAU ) in preventing relapse to major depressive disorder ( MDD ) in people currently in remission following at least 3 previous episodes .
-METHODS	A randomized controlled trial in which 274 participants were allocated in the ratio 2:2:1 to MBCT plus TAU , CPE plus TAU , and TAU alone , and data were analyzed for the 255 ( 93 % ; MBCT = 99 , CPE = 103 , TAU = 53 ) retained to follow-up .
-METHODS	MBCT was delivered in accordance with its published manual , modified to address suicidal cognitions ; CPE was modeled on MBCT , but without training in meditation .
-METHODS	Both treatments were delivered through 8 weekly classes .
-RESULTS	Allocated treatment had no significant effect on risk of relapse to MDD over 12 months follow-up , hazard ratio for MBCT vs. CPE = 0.88 , 95 % CI [ 0.58 , 1.35 ] ; for MBCT vs. TAU = 0.69 , 95 % CI [ 0.42 , 1.12 ] .
-RESULTS	However , severity of childhood trauma affected relapse , hazard ratio for increase of 1 standard deviation = 1.26 ( 95 % CI [ 1.05 , 1.50 ] ) , and significantly interacted with allocated treatment .
-RESULTS	Among participants above median severity , the hazard ratio was 0.61 , 95 % CI [ 0.34 , 1.09 ] , for MBCT vs. CPE , and 0.43 , 95 % CI [ 0.22 , 0.87 ] , for MBCT vs. TAU .
-RESULTS	For those below median severity , there were no such differences between treatment groups .
-CONCLUSIONS	MBCT provided significant protection against relapse for participants with increased vulnerability due to history of childhood trauma , but showed no significant advantage in comparison to an active control treatment and usual care over the whole group of patients with recurrent depression .
-
-###25233569
-BACKGROUND	The aim of this study was to evaluate the patient 's perceived pain response to injection and anesthetic deposition for the greater palatine nerve block .
-METHODS	Heft-Parker Visual Analog Scale ( VAS ) pain scale measurements were used to compare the following techniques for the injection : ( 1 ) control ( no concurrent stimulation ) , ( 2 ) pressure , ( 3 ) pressure and topical anesthetic ( 20 % benzocaine ) , and ( 4 ) pressure and cold ( TFE ) .
-METHODS	Forty-two volunteers , 21 male and 21 female , participated in the study .
-METHODS	A bilateral model was used on each patient to give an injection on each side of the palate with two different techniques followed by the next appointment ( > or = two weeks later ) , when the two other injection techniques were used .
-METHODS	Following injection given in the supine position , the patients were returned to an upright position and asked to rate their pain on a VAS .
-RESULTS	Pain upon needle insertion appears less than that of anesthetic deposition .
-RESULTS	There was no statistically significant difference in perceived pain response among the four techniques , the visit , the order , the side , or patient gender at either time point .
-RESULTS	Following the application of Endo Ice , 81 % of participants reported a sore on their palate occurring two to 48 hours after cold application and persisting for one to 10 days .
-RESULTS	The pain score for this injection had a mean value of 30 % ( 51.4 / 170 ) .
-CONCLUSIONS	This prospective , single-blind study evaluating three injection techniques to reduce posterior palatal injection pain to a control injection method showed no significant reduction in pain with any of the three techniques .
-CONCLUSIONS	Furthermore , 1,1,1,2-tetrafluoroethane placed with pressure for 10 seconds appeared injurious to the oral mucosa .
-
-###25034216
-BACKGROUND	Continuous glucose monitoring ( CGM ) has been shown to improve glucose control in adults with type 1 diabetes .
-BACKGROUND	Effectiveness of CGM is directly linked with CGM adherence , which can be challenging to maintain in children and adolescents .
-BACKGROUND	We hypothesize that initiating CGM at the same time as starting insulin pump therapy in pump nave children and adolescents with type 1 diabetes will result in greater CGM adherence and effectiveness compared to delaying CGM introduction by 6 months , and that this is related to greater readiness for making behaviour change at the time of pump initiation .
-METHODS	The CGM TIME Trial is a multicenter randomized controlled trial .
-METHODS	Eligible children and adolescents ( 5-18 years ) with established type 1 diabetes were randomized to simultaneous initiation of pump ( Medtronic Veo ) and CGM ( Enlite ) or to standard pump therapy with delayed CGM introduction .
-METHODS	Primary outcomes are CGM adherence and hemoglobin A1C at 6 and 12 months post pump initiation .
-METHODS	Secondary outcomes include glycemic variability , stage of readiness , and other patient-reported outcomes with follow-up to 24 months .
-METHODS	144 ( 95 % ) of the 152 eligible patients were enrolled and randomized .
-METHODS	Allowing for 10 % withdrawals , this will provide 93 % power to detect a between group difference in CGM adherence and 86 % power to detect a between group difference in hemoglobin A1C .
-METHODS	Baseline characteristics were similar between the treatment groups .
-METHODS	Analysis of 12 month primary outcomes will begin in September 2014 .
-CONCLUSIONS	The CGM TIME Trial is the first study to examine the relationship between timing of CGM initiation , readiness for behaviour change , and subsequent CGM adherence in pump nave children and adolescents .
-CONCLUSIONS	Its findings will advance our understanding of when and how to initiate CGM in children and adolescents with type 1 diabetes .
-BACKGROUND	ClinicalTrial.gov NCT01295788 .
-BACKGROUND	Registered 14 February 2011 .
-
-###25262434
-OBJECTIVE	Early statin therapy after acute coronary syndrome reduces atherothrombotic vascular events .
-OBJECTIVE	This study aimed to compare the effects of hydrophilic and hydrophobic statins on myocardial salvage and left ventricular ( LV ) function in patients with ST-elevated myocardial infarction ( STEMI ) .
-METHODS	Seventy-five STEMI patients who had received emergency reperfusion therapy were enrolled and randomized into the hydrophilic statin group ( rosuvastatin ; 5 mg/day , n = 38 ) and hydrophobic statin group ( atorvastatin ; 10 mg/day , n = 37 ) for 6 months .
-METHODS	LV ejection fraction ( LVEF ) , and B-type natriuretic peptide ( BNP ) and co-enzyme Q10 ( CoQ10 ) levels were measured at baseline and the end of treatment .
-METHODS	The myocardial salvage index was assessed by single photon emission computed tomography with ( 123 - ) I -- methyl-iodophenylpentadecanoic acid ( ischemic area-at-risk at onset of STEMI : AAR ) and ( 201 - ) thallium scintigraphy ( area-at-infarction at 6 months : AAI ) [ myocardial salvage index = ( AAR-AAI ) 100/AAR ( % ) ] .
-RESULTS	Onset-to-balloon time and maximum creatine phosphokinase levels were comparable between the groups .
-RESULTS	After 6 months , rosuvastatin ( -37.6 % 17.2 % ) and atorvastatin ( -32.4 % 22.4 % ) equally reduced low-density lipoprotein-cholesterol ( LDL-C ) levels ( p = 0.28 ) .
-RESULTS	However , rosuvastatin ( +3.1 % 5.9 % , p < 0.05 ) , but not atorvastatin ( +1.6 % 5.7 % , p = 0.15 ) , improved LVEF .
-RESULTS	Rosuvastatin reduced BNP levels compared with atorvastatin ( -53.3 % 48.8 % versus -13.8 % 82.9 % , p < 0.05 ) .
-RESULTS	The myocardial salvage index was significantly higher in the rosuvastatin group than the atorvastatin group ( 78.6 % 29.1 % versus 52.5 % 38.0 % , p < 0.05 ) .
-RESULTS	CoQ10/LDL-C levels at 6 months were increased in the rosuvastatin group ( +23.5 % , p < 0.01 ) and percent changes in CoQ10/LDL-C were correlated with the myocardial salvage index ( r = 0.56 , p < 0.01 ) .
-CONCLUSIONS	Rosuvastatin shows better beneficial effects on myocardial salvage than atorvastatin in STEMI patients , including long-term cardiac function , associated with increasing CoQ10/LDL-C .
-BACKGROUND	URL http://www.umin.ac.jp/ctr/index.htm Unique Identifier : UMIN000003893 .
-
-###24746254
-BACKGROUND	Laparoscopic common bile duct exploration ( LCBDE ) is now one of the main methods for treating choledocholithiasis accompanied with cholelithiasis .
-BACKGROUND	The objective of our study was to assess the safety and effectiveness of laparoscopic primary closure for the treatment of common bile duct ( CBD ) stones compared with T-tube drainage .
-METHODS	Patients who underwent CBD stones were studied prospectively from 2002-2012 in a single center .
-METHODS	A total of 194 patients were randomly assigned to group A ( LCBDE with primary closure ) with 101 cases and group B ( LCBDE with T-tube drainage ) with 93 cases .
-METHODS	Intraoperative cholangiography and choledochoscopy were performed in all patients .
-METHODS	Patient demographics , intraoperative findings , postoperative stay , complications , and hospital expenses were recorded and analyzed .
-RESULTS	There was no mortality in the two groups .
-RESULTS	Four patients ( 3.96 % ) of group A were converted to open surgery , and three patients ( 3.23 % ) in group B.
-RESULTS	The mean operating time was much shorter in group A than in group B ( 102.6 15.2 min versus 128.6 20.4 min , P < 0.05 ) .
-RESULTS	The length of postoperative hospital stay was longer in group B ( 4.9 3.2 d ) than in group A ( 3.2 2.1 d ) .
-RESULTS	The hospital expenses were significantly lower in group A. Three patients experienced postoperative complications , which were related to the usage of the T-tube in group B.
-RESULTS	The incidences of overall postoperative complications were insignificantly lower in group A.
-CONCLUSIONS	Laparoscopic primary closure of CBD is safe and effective for the management of CBD stones , and can be performed routinely as an alternative to T-tube drainage .
-
-###24325584
-OBJECTIVE	A recently discovered myokine , irisin , may have an important role in energy metabolism .
-OBJECTIVE	This study aimed to evaluate the relationship between this hormone and the lipid profile of patients with metabolic syndrome ( MetS ) following a hypocaloric diet .
-METHODS	Ninety-three Caucasian adults ( 52 men/41 women ) diagnosed with MetS followed an 8-week-long energy-restricted programme ( -30 % of the energy requirements ) .
-METHODS	Anthropometric measurements , biochemical markers and plasma irisin levels were analysed before and after the nutritional intervention .
-RESULTS	Global plasma irisin levels were significantly reduced at the end of the study ( -72.0 100.9 ng/ml , P < 0.001 ) accompanying the weight loss ( -6.9 % ) .
-RESULTS	The depletion of irisin significantly correlated with changes in some atherogenic-related variables : total cholesterol ( B = 0.106 , P = 0.018 ) , total cholesterol/high-density lipoprotein cholesterol ratio ( B = 0.002 , P = 0.036 ) , low-density lipoprotein cholesterol ( B = 0.085 , P = 0.037 ) and apolipoprotein B ( B = 0.052 , P = 0.002 ) , independently of changes in body weight .
-CONCLUSIONS	An association between the reduction in plasma irisin levels and the depletion of important lipid metabolism biomarkers was observed in patients with MetS undergoing an energy-restricted programme .
-
-###25012957
-BACKGROUND	The 23-valent pneumococcal polysaccharide vaccine is recommended for elders , especially those with chronic conditions .
-OBJECTIVE	The aim of this study was to determine if an additional multi-component health education intervention increases the uptake rate of the pneumococcal vaccination among older patients with chronic diseases .
-METHODS	A cluster randomized controlled trial was conducted from 3 December 2007 to 7 March 2008 .
-METHODS	The clusters were the individual weeks within five Hong Kong outpatient clinics over a 10-week period .
-METHODS	A sample of 2517 patients aged 65 or above with chronic diseases was recruited .
-METHODS	Intervention group received a 3-min brief telephone education intervention before and a 3-min face-to-face intervention during scheduled medical appointments at the respective clinics .
-METHODS	All subjects received standard care including health education leaflets and/or a video show at the clinics .
-METHODS	Pneumococcal vaccination rate and awareness of the vaccination at 3-month follow up were measured .
-RESULTS	The vaccination rate was higher in the intervention group compared to the control group ( 57 % vs 48 % ; relative risk = 1.20 , 95 % CI = 1.06-1 .37 ) , but the two groups did not differ significantly in their awareness of the vaccination at 3-month follow up ( 65 % vs 59 % , relative risk = 0.86 , 95 % CI = 0.69-1 .07 ) .
-CONCLUSIONS	A nurse-delivered brief health education intervention was effective in increasing uptake of pneumococcal vaccination among older patients with chronic diseases .
-
-###25035114
-BACKGROUND	In assessing quality of care in developing countries , retrospectively collected data are usually used given their availability .
-BACKGROUND	Retrospective data however suffer from such biases as recall bias and non-response bias .
-BACKGROUND	Comparing results obtained using prospectively and retrospectively collected data will help validate the use of the easily available retrospective data in assessing quality of care in past and future studies .
-METHODS	Prospective and retrospective datasets were obtained from a cluster randomized trial of a multifaceted intervention aimed at improving paediatric inpatient care conducted in eight rural Kenyan district hospitals by improving management of children admitted with pneumonia , malaria and diarrhea and/or dehydration .
-METHODS	Four hospitals received a full intervention and four a partial intervention .
-METHODS	Data were collected through 3 two weeks surveys conducted at baseline , after 6 and 18 months .
-METHODS	Retrospective data was sampled from paediatric medical records of patients discharged in the preceding six months of the survey while prospective data was collected from patients discharged during the two week period of each survey .
-METHODS	Risk Differences during post-intervention period of 16 quality of care indicators were analyzed separately for prospective and retrospective datasets and later plotted side by side for comparison .
-RESULTS	For the prospective data there was strong evidence of an intervention effect for 8 of the indicators and weaker evidence of an effect for one indicator , with magnitude of effect sizes varying from 23 % to 60 % difference .
-RESULTS	For the retrospective data , 10 process ( these include the 8 indicators found to be statistically significant in prospective data analysis ) indicators had statistically significant differences with magnitude of effects varying from 10 % to 42 % .
-RESULTS	The bar-graph comparing results from the prospective and retrospective datasets showed similarity in terms of magnitude of effects and statistical significance for all except two indicators .
-CONCLUSIONS	Multifaceted interventions can help improve adoption of clinical guidelines and hence improve the quality of care .
-CONCLUSIONS	The similar inference reached after analyses based on prospective assessment of case management is a useful finding as it supports the utility of work based on examination of retrospectively assembled case records allowing longer time periods to be studied while constraining costs .
-BACKGROUND	Current Controlled Trials ISRCTN42996612 .
-BACKGROUND	Trial registration date : 20/11/2008 .
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-###24863954
-OBJECTIVE	Poor patient understanding of their diagnosis and treatment plan can adversely impact clinical outcome following hospital discharge .
-OBJECTIVE	Discharge summaries are primarily written for the doctor rather than the patient .
-OBJECTIVE	We determined patient understanding of the reasons for hospitalisation , in-hospital tests , treatments and post-discharge recommendations , and whether a brief patient-directed discharge letter ( PADDLE ) delivered during a brief discussion prior to discharge would improve understanding .
-METHODS	A prospective randomised controlled trial was conducted , including 67 hospitalised patients .
-METHODS	After a baseline questionnaire , patients were randomised to receive the PADDLE letter or usual care .
-METHODS	Those receiving the letter had an immediate follow-up questionnaire .
-METHODS	Patient understanding was compared with a summary letter written by the treating clinician , using a 5-point Likert scale ranging from none to full understanding .
-METHODS	A questionnaire was administered at 3 and 6 months .
-RESULTS	At baseline , patients had almost full understanding ( median score 4 ) of reasons for hospitalisation and treatments .
-RESULTS	However , despite high self-appraisal , patients objectively had very little understanding of tests performed and post-discharge recommendations ( median 2 ) .
-RESULTS	Those receiving the letter had an immediate increase to almost full understanding ( median 4 ) of tests performed ( P < 0.001 ) and to full understanding ( median 5 ) of post-discharge recommendations .
-RESULTS	This increase did not persist at 3 or 6 months .
-CONCLUSIONS	A simple patient-directed letter delivered during a brief discussion improves patient understanding of their hospitalisation and post-discharge recommendations , which is otherwise limited .
-CONCLUSIONS	Further evaluation of this brief and well-received intervention is indicated , with the goal of improving patient understanding , satisfaction and clinical outcomes .
-
-###25315148
-BACKGROUND	Patient reported outcome measures ( PROMs ) are used to evaluate lifestyle interventions but little is known about differences between patients returning valid and invalid responses , or of potential for bias in evaluations .
-BACKGROUND	We aimed to examine the characteristics of patients who returned valid responses to lifestyle questionnaires compared to those whose responses were invalid for evaluating lifestyle change .
-METHODS	We conducted a secondary data analysis from the SPHERE Study , a trial of an intervention to improve outcomes for patients with coronary heart disease in primary care .
-METHODS	Postal questionnaires were used to assess physical activity ( Godin ) and diet ( DINE ) among study participants at baseline and 18 month follow-up .
-METHODS	Three binary response variables were generated for analysis : ( 1 ) valid Godin score ; ( 2 ) valid DINE Fibre score ; and ( 3 ) valid DINE Total Fat score .
-METHODS	Multivariate analysis comprised generalised estimating equation regression to examine the association of patients ' characteristics with their return of valid responses at both timepoints .
-RESULTS	Overall , 92.1 % of participants ( 832/903 ) returned questionnaires at both baseline and 18 months .
-RESULTS	Relatively fewer valid Godin scores were returned by those who left school aged < 15 years ( 36.5 % ) than aged 18 and over ( 50.5 % ) , manual workers ( 39.5 % ) than non-manual ( 49.5 % ) and those with an elevated cholesterol ( > 5 mmol ) ( 34.7 % ) than those with a lower cholesterol ( 44.4 % ) but multivariate analysis identified that only school leaving age ( p = 0.047 ) was of statistical significance.Relatively fewer valid DINE scores were returned by manual than non-manual workers ( fibre : 80.8 % v 86.8 % ; fat : 71.2 % v 80.0 % ) , smokers ( fibre : 72.6 % v 84.7 % ; fat : 67.5 % v 76.9 % ) , patients with diabetes ( fibre : 75.9 % v 82.9 % ; fat : 66.9 % v 75.8 % ) and those with cholesterol > 5 mmol ( fat : 68.2 % v 76.2 % ) but multivariate analysis showed statistical significance only for smoking ( fibre : p = 0.013 ; fat : p = 0.045 ) , diabetes ( fibre : p = 0.039 ; fat : p = 0.047 ) , and cholesterol ( fat : p = 0.039 ) .
-CONCLUSIONS	Our findings illustrate the importance of detailed reporting of research methods , with clear information about response rates , respondents and valid outcome data .
-CONCLUSIONS	Outcome measures which are relevant to a study population should be chosen carefully .
-CONCLUSIONS	The impact of methods of outcome measurement and valid response rates in evaluating healthcare requires further study .
-
-###24304291
-BACKGROUND	Previous studies have shown that a calcium ( Ca ) pre-rinse given before a 228 ppm fluoride ( F ) rinse greatly increased salivary fluoride .
-BACKGROUND	Objectives .
-BACKGROUND	The aim of this randomized controlled trial is to examine if Ca pre-rinse could increase the fluoride concentration in the overnight unstimulated saliva after a 905 ppm F-rinse .
-METHODS	Pre-rinses containing 150 mM , 75 mM or 0 mM Ca-lactate prepared by a validated pharmaceutical cGPM procedure were tested by nine subjects in a randomized order immediately followed by a 905 ppm F-rinse .
-METHODS	The fluoride concentration was measured in unstimulated saliva collected 10 h later .
-CONCLUSIONS	The Ca pre-treatment significantly increased F level in overnight saliva following the 905 ppm fluoride rinse by 1.7 relative to the 905 ppm F-rinse alone ; however , a significant effect was only observed with the highest ( 150 mM ) Ca concentration as pre-rinse .
-CONCLUSIONS	Clinical relevance .
-CONCLUSIONS	High concentration F rinses ( 905 ppm ) are commonly recommended for patients at high-risk of caries .
-CONCLUSIONS	A pre-treatment with high levels of Ca may further improve the cariostatic effect of this ion .
-
-###25035882
-OBJECTIVE	Social media sites , such as Facebook , merge two factors that influence risk for eating disorders : media and peers .
-OBJECTIVE	Previous work has identified cross-sectional and temporal associations between Facebook use and disordered eating .
-OBJECTIVE	This study sought to replicate and extend these findings using an experimental design .
-METHODS	In Study 1 , 960 women completed self-report surveys regarding Facebook use and disordered eating .
-METHODS	In Study 2 , 84 women were randomly assigned to use Facebook or to use an alternate internet site for 20 min .
-RESULTS	More frequent Facebook use was associated with greater disordered eating in a cross-sectional survey .
-RESULTS	Facebook use was associated with the maintenance of weight/shape concerns and state anxiety compared to an alternate internet activity .
-CONCLUSIONS	Facebook use may contribute to disordered eating by maintaining risk for eating pathology .
-CONCLUSIONS	As such , targeting Facebook use may be helpful in intervention and prevention programs .
-
-###25294250
-BACKGROUND	Oritavancin is a lipoglycopeptide antibiotic with rapid bactericidal activity against gram-positive bacteria .
-BACKGROUND	Its concentration-dependent activity and long half-life allow for single-dose treatment .
-METHODS	In a randomized , double-blind trial , adults with acute bacterial skin and skin structure infections ( ABSSSIs ) received either a single intravenous 1200-mg dose of oritavancin or 7-10 days of twice-daily vancomycin .
-METHODS	Three efficacy endpoints were tested for noninferiority : ( 1 ) primary composite endpoint at 48-72 hours ( cessation of spreading or reduction in lesion size , absence of fever , and no rescue antibiotic ) ; ( 2 ) investigator-assessed clinical cure 7-14 days after end of treatment ; and ( 3 ) 20 % reduction in lesion area at 48-72 hours .
-RESULTS	A total of 503 and 502 patients comprised the modified intent-to-treat population for oritavancin and vancomycin , respectively .
-RESULTS	All 3 efficacy endpoints met the 10 % noninferiority margin : the primary composite endpoint ( 80.1 % vs 82.9 % ; 95 % confidence interval [ CI ] , -7.5 to 2.0 ) , investigator-assessed clinical cure ( 82.7 % vs 80.5 % ; 95 % CI , -2.6 to 7.0 ) , and proportion of patients attaining 20 % reduction in lesion area ( 85.9 % vs 85.3 % ; 95 % CI , -3.7 to 5.0 ) for oritavancin vs vancomycin , respectively .
-RESULTS	Efficacy outcomes by pathogen , including methicillin-resistant Staphylococcus aureus and the frequency of adverse events , were similar between treatment groups .
-CONCLUSIONS	A single 1200-mg dose of oritavancin was noninferior to 7-10 days of vancomycin in treating ABSSSIs caused by gram-positive pathogens , and was well tolerated .
-CONCLUSIONS	Oritavancin provides a single-dose alternative to multidose therapies for the treatment of ABSSSIs .
-CONCLUSIONS	Clinical Trials Registration .
-CONCLUSIONS	NCT01252732 .
-
-###24528934
-OBJECTIVE	To test a combination of dexamethasone intravitreal implant with macular grid laser for macular edema in patients with branch retinal vein occlusion ( BRVO ) .
-METHODS	Prospective interventional , randomized , multicenter study .
-METHODS	Patients with macular edema secondary to BRVO underwent an Ozurdex intravitreal implant at baseline .
-METHODS	After 1 month , patients were randomly assigned to 2 study groups .
-METHODS	Patients in Group 1 were followed up monthly and retreated with Ozurdex implant whenever there was a recurrence of macular edema or a decrease in best-corrected visual acuity ( BCVA ) .
-METHODS	In Group 2 patients macular grid laser was performed between weeks 6 and 8 .
-METHODS	After that , patients were followed up and retreated as for Group 1 .
-RESULTS	In Group 1 at 4 months , mean BCVA was 0.49 0.35 logMAR and central retinal thickness ( CRT ) was 391 172 m ; both improved significantly at 6 months , to 0.32 0.29 logMAR and 322 160 m , respectively .
-RESULTS	In Group 2 , CRT was reduced significantly to 291 76 m at 4 months , and BCVA improved to 0.25 0.20 logMAR .
-RESULTS	At the final visit , BCVA was 0.18 0.14 logMAR and mean CRT was 271 44 m.
-RESULTS	The number of Ozurdex implants at 4 months was 12 of 25 ( 48 % ) in Group 1 patients vs 3 of 25 ( 12 % ) in Group 2 patients ( P = .012 ) .
-RESULTS	At 6 months 3 of 25 patients ( 12 % ) in Group 1 vs 0 of 25 ( 0 % ) in Group 2 ( P = .23 ) were retreated .
-CONCLUSIONS	The combination of Ozurdex implant and macular grid laser is synergistic in increasing BCVA and lengthening the time between injections .
-
-###25122150
-BACKGROUND	Pulmonary arterial hypertension ( PAH ) is a progressive disease with high rates of morbidity and mortality .
-BACKGROUND	Current therapies improve symptoms , functional capacity , and , in select cases , survival .
-BACKGROUND	Little is known about patient factors that may predict the likelihood of patient-important , clinically relevant responses to therapy such as the 6-min walk distance ( 6MWD ) and health-related quality of life ( HRQoL ) .
-METHODS	Data from the randomized clinical trial of tadalafil in PAH were used .
-METHODS	Adjusted logistic regression models were created to examine the relationship between baseline characteristics and odds of achieving the minimal important difference ( MID ) in three parameters , defined as either a > 33-m increase in 6MWD , a > 5-unit increase in physical component summary score of the Medical Outcomes Study Short Form-36 ( SF-36 ) , or a > 5-unit increase in mental component summary score of the SF-36 .
-RESULTS	The study included 405 subjects .
-RESULTS	Younger age , male sex , lower baseline 6MWD , and disease etiology were associated with greater odds of achieving the MID for the 6-min walk test .
-RESULTS	Active treatment , younger age , and male sex were associated with greater odds of achieving the MID for the physical component summary score .
-RESULTS	Male sex was associated with greater odds of achieving the MID for the mental component summary score .
-CONCLUSIONS	Age , sex , baseline functional capacity , and disease etiology are variably associated with the likelihood of achieving clinically relevant responses in patient-important outcomes to PAH-specific therapy such as 6MWD and HRQoL .
-CONCLUSIONS	The increased likelihood of response in men compared with women is a novel finding and may reflect pathophysiologic differences between sexes .
-
-###24288395
-BACKGROUND	Vascular calcification is a potent predictor of plaque instability and cardiac events .
-BACKGROUND	Osteoprotegerin ( OPG ) , well-known vascular calcification mediator , is a signaling molecule involved in bone remodeling , which has been implicated in the regulation of vascular calcification and atherogenesis .
-BACKGROUND	The purpose of this study was to compare the combination treatments of olmesartan/azelnidipine and olmesartan/diuretics on serum bone-related markers in patients with essential hypertension .
-RESULTS	A total of 48 patients with hypertension treated with 20 mg olmesartan were randomized to receive combination treatment with 16 mg azelnidipine ( O/A group ) or diuretics ( 1 mg indapamide ; O/D group ) for 12 months .
-RESULTS	Osteoprotegerin , matrix metalloproteinase 2 ( MMP-2 ) , and high-sensitive CRP ( hs-CRP ) were measured after 3 and 12 months of treatment .
-RESULTS	Cardio-ankle vascular index ( CAVI ) was measured as the arterial stiffness using a VaSera CAVI instrument at the same time points .
-RESULTS	In both groups , the systolic and diastolic blood pressure reduction is similar .
-RESULTS	Serum OPG , MMP-2 , and hs-CRP were significantly decreased at 12 months in the O/A group ( P < .05 ) , while there were no significant reductions in the O/D group .
-RESULTS	CAVI was significantly improved at 12 months in both the treatment groups .
-RESULTS	The improvement in CAVI was significantly greater in the O/A group than in the O/D group .
-CONCLUSIONS	Azelnidipine , but not indapamide , combined with olmesartan , improved arterial stiffness and were associated with significant decrease in OPG , MMP-2 , and hs-CRP concentrations .
-CONCLUSIONS	These results suggest that the beneficial effects of the combination treatments of olmesartan/azelnidipine on arterial stiffness are mediated by alteration in bone-remodeling and inflammatory markers .
-
-###25653199
-BACKGROUND	Excessive alcohol use is a prevalent and worldwide problem .
-BACKGROUND	Excessive drinking causes a significant burden of disease and is associated with both morbidity and excess mortality .
-BACKGROUND	Prototype alteration and provision of a cue reminder could be useful strategies to enhance the effectiveness of online tailored interventions for excessive drinking .
-OBJECTIVE	Through a Web-based randomized controlled trial , 2 strategies ( ie , prototype alteration and cue reminders ) within an existing online personalized feedback intervention ( Drinktest ) aimed to reduce adults ' excessive drinking .
-OBJECTIVE	It was expected that both strategies would add to Drinktest and would result in reductions in alcohol consumption by intrinsic motivation and the seizure of opportunities to act .
-METHODS	Participants were recruited online and through printed materials .
-METHODS	Excessive drinking adults ( N = 2634 ) were randomly assigned to 4 conditions : original Drinktest , Drinktest plus prototype alteration , Drinktest plus cue reminder , and Drinktest plus prototype alteration and cue reminder .
-METHODS	Evaluation took place at 1-month posttest and 6-month follow-up .
-METHODS	Differences in drinking behavior , intentions , and behavioral willingness ( ie , primary outcomes ) were assessed by means of longitudinal multilevel analyses using a last observation carried forward method .
-METHODS	Measures were based on self-reports .
-RESULTS	All conditions showed reductions in drinking behavior and willingness to drink , and increased intentions to reduce drinking .
-RESULTS	Prototype alteration ( B = -0.15 , P < .05 ) and cue reminder usage ( B = -0.15 , P < .05 ) were both more effective in reducing alcohol consumption than when these strategies were not provided .
-RESULTS	Combining the strategies did not produce a synergistic effect .
-RESULTS	No differences across conditions were found regarding intentions or willingness .
-CONCLUSIONS	Although individuals ' awareness of their cue was reasonable , their reported alcohol consumption was nevertheless reduced .
-CONCLUSIONS	Individuals appeared to distance their self-image from heavier drinking prototypes .
-CONCLUSIONS	Thus , prototype alteration and cue reminder usage may be feasible and simple intervention strategies to promote reductions in alcohol consumption among adults , with an effect up to 6 months .
-BACKGROUND	Nederlands Trial Register ( NTR ) : 4169 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4169 ( Archived by WebCite at http://www.webcitation.org/6VD2jnxmB ) .
-
-###24604881
-BACKGROUND	Evidence suggests depression increases hospital readmission risk .
-OBJECTIVE	Determine whether depressive symptoms are associated with unplanned readmission within 30 days of discharge of general medical patients .
-METHODS	Secondary analysis of the Project Re-Engineered Discharge ( RED ) randomized controlled trials .
-METHODS	Urban academic safety-net hospital .
-METHODS	A total of 1418 hospitalized adult English-speaking patients .
-METHODS	The 9-Item Patient Health Questionnaire ( PHQ-9 ) was used to screen patients for depressive symptoms .
-METHODS	Hospital readmission within 30 days of discharge .
-METHODS	Poisson regression was used to control for confounding variables .
-RESULTS	There were 225 ( 16 % ) patients who screened positive for mild depressive symptoms ( 5 PHQ-9 9 ) and 336 ( 24 % ) for moderate or severe depressive symptoms ( PHQ-9 10 ) .
-RESULTS	After controlling for confounders , a higher rate of readmission was observed in subjects with mild depressive symptoms compared to subjects with PHQ-9 < 5 , incidence rate ratio ( IRR ) 1.49 ( 95 % confidence interval [ CI ] : 1.11-2 .00 ) .
-RESULTS	The adjusted IRR of readmission for those with moderate-to-severe symptoms was 1.96 ( 95 % CI : 1.51-2 .49 ) compared to those with no depression .
-CONCLUSIONS	Screening positive for mild and moderate-to-severe depressive symptoms during a hospitalization on a general medical service is associated with an increased dose-dependent readmission rate within 30 days of discharge in an urban , academic , safety-net hospital .
-CONCLUSIONS	Further research is needed to determine whether treatments targeting the reduction of depressive symptoms reduce the risk of readmission .
-
-###25688781
-OBJECTIVE	Gaucher disease type 1 is characterized by hepatosplenomegaly , anemia , thrombocytopenia , and skeletal disease .
-OBJECTIVE	A safe , effective oral therapy is needed .
-OBJECTIVE	To determine whether eliglustat , a novel oral substrate reduction therapy , safely reverses clinical manifestations in untreated adults with Gaucher disease type 1 .
-METHODS	Phase 3 , randomized , double-blind , placebo-controlled trial conducted at 18 sites in 12 countries from November 2009 to July 2012 among eligible patients with splenomegaly plus thrombocytopenia and/or anemia .
-METHODS	Of 72 patients screened , 40 were enrolled .
-METHODS	Patients were stratified by spleen volume and randomized 1:1 to receive eliglustat ( 50 or 100 mg twice daily ; n = 20 ) or placebo ( n = 20 ) for 9 months .
-METHODS	The primary efficacy end point was percentage change in spleen volume in multiples of normal from baseline to 9 months ; secondary efficacy end points were change in hemoglobin level and percentage changes in liver volume and platelet count .
-RESULTS	All patients had baseline splenomegaly and thrombocytopenia ( mostly moderate or severe ) , most had mild or moderate hepatomegaly , and 20 % had mild anemia .
-RESULTS	Least-square mean spleen volume decreased by 27.77 % ( 95 % CI , -32.57 % to -22.97 % ) in the eliglustat group ( from 13.89 to 10.17 multiples of normal ) vs an increase of 2.26 % ( 95 % CI , -2.54 % to 7.06 % ) in the placebo group ( from 12.50 to 12.84 multiples of normal ) for an absolute treatment difference of -30.03 % ( 95 % CI , -36.82 % to -23.24 % ; P < .001 ) .
-RESULTS	For the secondary end points , the least-square mean absolute differences between groups all favored eliglustat , with a 1.22-g / dL increase in hemoglobin level ( 95 % CI , 0.57-1 .88 g/dL ; P < .001 ) , 6.64 % decrease in liver volume ( 95 % CI , -11.37 % to -1.91 % ; P = .007 ) , and 41.06 % increase in platelet count ( 95 % CI , 23.95 % -58.17 % ; P < .001 ) .
-RESULTS	No serious adverse events occurred .
-RESULTS	One patient in the eliglustat group withdrew ( non-treatment related ) ; 39 of the 40 patients transitioned to an open-label extension study .
-CONCLUSIONS	Among previously untreated adults with Gaucher disease type 1 , treatment with eliglustat compared with placebo for 9 months resulted in significant improvements in spleen volume , hemoglobin level , liver volume , and platelet count .
-CONCLUSIONS	The clinical significance of these findings is uncertain , and more definitive conclusions about clinical efficacy and utility will require comparison with the standard treatment of enzyme replacement therapy as well as longer-term follow-up .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00891202 .
-
-###24848282
-OBJECTIVE	To investigate urine excretion of nephrin in patients with proteinuric nephropathies associated with rheumatoid arthritis ( RA ) .
-METHODS	We enrolled in the study 42 patients with seropositive RA and proteinuria , the control group ( 20 persons ) was formed from healthy blood donors , the comparison group ( 23 persons ) was formed from RA patients without proteinuria .
-METHODS	Kidney biopsy was performed in 26 patients ( glomerulonephritis was diagnosed in 14 patients , - amyloidosis in 7 patients and tubulointerstitial nephritis in 5 patients ) .
-RESULTS	Urine nephrin concentration in patients with RA and proteinuria was 6.2 ( 3.0 ; 8.8 ) ng/ml and significantly differed in its levels both in controls - 3.6 ( 2.4 ; 5.3 ) ng/ml ( p = 0.03 ) and RA patients without proteinuria - 3.2 ( 2.1 ; 5.1 ) ng / ml ( p = 0.015 ) group .
-RESULTS	In RA patients with proteinuria , we found a positive correlation between urine nephrin and protein concentrations ( r = 0.4 ; p = 0.04 ) .
-RESULTS	Urine nephrin levels in patients of the glomerulonephritis - 7.3 ( 5.9 ; 9.2 ) and amyloidosis groups - 6.9 ( 3.9 ; 9.8 ) ng/ml were higher than in the controls ( p = 0.001 ; p = 0.04 ) and in the group of patients without proteinuria ( p = 0.005 ; p = 0.03 ) .
-RESULTS	In the patients with tubulointerstitial nephritis urine nephrin concentration did not differ significantly with the values in both the control and the RA patients without proteinuria groups .
-CONCLUSIONS	According to our data , proteinuria in the overall cohort of patients with seropositive RA is associated with increased levels of urine nephrin excretion , the highest levels of nephrin excretion were registered in patients with glomerulonephritis and amyloidosis .
-
-###25416496
-BACKGROUND	Depression is one the most common mental disorders that can be seen all over the world .
-BACKGROUND	In traditional Persian medicine , some medicinal herbs are recommended for depression treatment .
-BACKGROUND	This study aimed to evaluate the effects of Cuscuta planiflora Ten .
-BACKGROUND	and Nepeta menthoides Boiss .
-BACKGROUND	& Buhse in patients with major depression .
-METHODS	This study is a randomized triple-blind controlled clinical trial conducted in the year 2010 in Shiraz University of Medical Sciences on patients with major depression .
-METHODS	Pharmaceutical capsules of Cuscuta planiflora ( 500 mg ) and Nepeta menthoides ( 400 mg ) were prepared by a pharmacist .
-METHODS	Patients were randomly assigned to 3 groups : group A ( treated with Nepeta menthoides capsules and conventional drugs ) , group B ( treated with Cuscuta planiflora capsules and conventional drugs ) , and group C ( treated only with conventional drugs ) .
-METHODS	The study period was 8 weeks and depression was measured before and after the study by Beck Depression Inventory and Hamilton Depression Inventory .
-METHODS	The data were analyzed by SPSS version 20 and the P < .05 was considered statistically significant .
-RESULTS	A total of 43 subjects participated in this study , of whom 81.4 % were females ( n = 35 ) and 18.6 % were males ( n = 8 ) .
-RESULTS	The mean standard deviation of age of the participants was 38 10.9 years .
-RESULTS	The majority of patients ( 65.1 % , n = 28 ) were married .
-RESULTS	There were 15 patients ( 34.9 % ) in group A , 13 ( 30.29 % ) in group B , and 15 ( 34.9 % ) in group C.
-RESULTS	There was a significant decrease in mean scores of Beck and Hamilton depression inventories in the 3 groups after treatment ( P < .01 ) ; moreover , there was more decrease in scores of the Beck and Hamilton depression inventories in groups A and B compared with group C after treatment ( P < .01 ) .
-CONCLUSIONS	Despite the paucity of the population under study , the findings showed that Cuscuta planiflora and Nepeta menthoides capsules could be effective , affordable herbal medicines with improved cost-benefit in treatment of major depression and it is worth designing further and more extensive studies to get to a more accurate conclusion .
-
-###24667038
-OBJECTIVE	To evaluate the effect of side-cut angle profile on corneal biomechanical properties after femtosecond laser in situ keratomileusis ( FS-LASIK ) .
-METHODS	Ninety-six myopic eyes of 48 patients underwent FS-LASIK .
-METHODS	One eye of each patient was randomized to flap creation with a side-cut angle of 115 .
-METHODS	The fellow eye flap side-cut angle was adjusted to 70 .
-METHODS	Mean absolute error of flap diameter and mean change in Goldmann-correlated intra-ocular pressure ( IOPg ) , corneal-compensated IOP ( IOPcc ) , corneal hysteresis ( CH ) , corneal resistance factor ( CRF ) , p1 area , p2 area , p1 area 1 and p2 area 1 were compared between both groups .
-RESULTS	Overall , the mean IOPg and CRF showed significant reduction at the end of 1 and 3months , as well as between 1 and 3months postoperatively ( p0 .03 ) .
-RESULTS	The mean IOPcc and CH showed significant reduction ( p < 0.001 ) at the end of 3months postoperatively .
-RESULTS	The parameters p1 area , p2 area , p1 area 1 and p2 area 1 changed significantly at the end of 1 and 3months postoperatively ( p < 0.001 ) .
-RESULTS	There was no significant difference between both groups with regards to the mean change of IOPg , IOPcc , CH , CRF , p1 area , and p1 area 1 .
-RESULTS	In 115 group , the mean absolute error in flap diameter was greater compared with 70 group ( p = 0.014 ) .
-CONCLUSIONS	The stability of IOP and corneal biomechanical properties were not enhanced in FS-LASIK flaps with an inverted side-cut angle .
-CONCLUSIONS	The size of corneal flap created with 70 side-cut angle was more accurate compared with 115 side-cut angle .
-
-###25764643
-OBJECTIVE	To study post-operative pain and blood loss after intraoperative periarticular injection with the multimodal drugs diclofenac , adrenaline , marcaine ( bupivacaine ) and morphine in total knee arthroplasty .
-METHODS	A prospective randomized controlled trial of knee osteoarthritis patients age more than 55 years undergoing total knee arthroplasty at Maharat Nakhon Ratchasima hospital from January 2011 through June 2012 was performed .
-METHODS	A group receiving intra-operative periarticular injections was compared to a control group receiving no injections .
-METHODS	Half of a group of forty-two patients , 2 males and 40 females , average age 67.9 years ( range 57-84 years ) , were randomly assigned to receive the periarticular injection ( the injection group ) , the others to the control group .
-METHODS	Pain was measured by two methods : visual analog score at 6 , 12 , 24 and 48 hours post-operation and by patient controlled analgesia ( PCA ) measuring the daily amount of intravenous morphine used .
-METHODS	The amount of blood loss post operation ( in the redivac drain ) , degree of knee flexion , time to onset of assisted ambulation , length of hospital stay and any complications were also analyzed .
-RESULTS	The mean VAS at 6 and 12 hours post operation of the injection group were 2.67 and 2.48 , whereas the values for the control group were 6.10 and 4.95 , respectively ( p < 0.05 ) .
-RESULTS	Mean quantities of morphine used by PCA by the injection group during the first day was 9.43 mg , significantly lower than the 18.81 mg used by the control group .
-RESULTS	Average blood loss of the injection group at 263.8 ml was also significantly below the 362.1 ml of the control group ( p < 0.05 ) .
-RESULTS	The degree of knee flexion , time to onset of assist ambulation , length of hospital stay and complications , however were not significantly different between the groups .
-CONCLUSIONS	Multimodal drugs , periarticular injections consisting of diclofenac , adrenaline , Marcaine plus a patient controled anesthetic machine ( PCA ) with morphine can significantly reduce post-operative pain and blood loss in total knee arthroplasty without significant adverse effects .
-
-###24861959
-OBJECTIVE	Most primary care clinicians lack the skills and resources to offer effective lifestyle and medication ( L&M ) counseling to reduce coronary heart disease ( CHD ) risk .
-OBJECTIVE	Thus , effective and feasible CHD prevention programs are needed for typical practice settings .
-OBJECTIVE	To assess the effectiveness , acceptability , and cost-effectiveness of a combined L&M intervention to reduce CHD risk offered in counselor-delivered and web-based formats .
-METHODS	A comparative effectiveness trial in 5 diverse family medicine practices in North Carolina .
-METHODS	Participants were established patients , aged 35 to 79 years , with no known cardiovascular disease , and at moderate to high risk for CHD ( 10-year Framingham Risk Score [ FRS ] , 10 % ) .
-METHODS	Participants were randomized to counselor-delivered or web-based format , each including 4 intensive and 3 maintenance sessions .
-METHODS	After randomization , both formats used a web-based decision aid showing potential CHD risk reduction associated with L&M risk-reducing strategies .
-METHODS	Participants chose the risk-reducing strategies they wished to follow .
-METHODS	The primary outcome was within-group change in FRS at 4-month follow-up .
-METHODS	Other measures included standardized assessments of blood pressure , blood lipid levels , lifestyle behaviors , and medication adherence .
-METHODS	Acceptability and cost-effectiveness were also assessed .
-METHODS	Outcomes were assessed at 4 and 12 months .
-RESULTS	Of 2274 screened patients , 385 were randomized ( 192 counselor ; 193 web ) : mean age , 62 years ; 24 % African American ; and mean FRS , 16.9 % .
-RESULTS	Follow-up at 4 and 12 months included 91 % and 87 % of the randomized participants , respectively .
-RESULTS	There was a sustained reduction in FRS at both 4 months ( primary outcome ) and 12 months for both counselor-based ( -2.3 % [ 95 % CI , -3.0 % to -1.6 % ] and -1.9 % [ 95 % CI , -2.8 % to -1.1 % ] , respectively ) and web-based groups ( -1.5 % [ 95 % CI , -2.2 % to -0.9 % ] and -1.7 % [ 95 % CI , -2.6 % to -0.8 % ] respectively ) .
-RESULTS	At 4 months , the adjusted difference in FRS between groups was -1.0 % ( 95 % CI , -1.8 % to -0.1 % ) ( P = .03 ) , and at 12 months , it was -0.6 % ( 95 % CI , -1.7 % to 0.5 % ) ( P = .30 ) .
-RESULTS	The 12-month costs from the payer perspective were $ 207 and $ 110 per person for the counselor - and web-based interventions , respectively .
-CONCLUSIONS	Both intervention formats reduced CHD risk through 12-month follow-up .
-CONCLUSIONS	The web format was less expensive .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01245686 .
-
-###25650503
-OBJECTIVE	This randomized , double-blind 8 week study compared the efficacy and tolerability of fixed-dose treatment with vortioxetine ( 10mg/day ) and venlafaxine extended release ( XR ) ( 150mg/day ) in major depressive disorder ( MDD ) patients .
-METHODS	Patients aged 18-65 years with a primary diagnosis of recurrent MDD , a Montgomery-sberg Depression Rating Scale ( MADRS ) total score 26 and a Clinical Global Impression-Severity ( CGI-S ) score 4 were randomized ( 1:1 ) to treatment with either vortioxetine or venlafaxine XR .
-METHODS	The primary endpoint was change from baseline to Week 8 in MADRS total score ( analysis of covariance [ ANCOVA ] , full-analysis set [ FAS ] , last observation carried forward [ LOCF ] ) , using a non-inferiority margin of +2.5 points .
-METHODS	Pre-specified secondary endpoints included MADRS response and remission rates , anxiety symptoms ( HAM-A ) , CGI , overall functioning ( SDS ) , and health-related quality of life ( Q-LES-Q ) .
-BACKGROUND	This study ( SOLUTION ) has the www.ClinicalTrials.gov identifier : NCT01571453 .
-RESULTS	On the primary efficacy endpoint at Week 8 , non-inferiority was established with a difference of -1.2 MADRS points in favor of vortioxetine ( 95 % CI : -3.0 to 0.6 ) .
-RESULTS	The MADRS total score decreased ( improved ) from 32.34.6 at baseline to 13.69.6 ( vortioxetine : n = 209 ) and from 32.34.5 to 14.810.4 ( venlafaxine XR : n = 215 ) ( FAS , LOCF ) .
-RESULTS	At Week 8 , the HAM-A and SDS total scores , CGI and Q-LES-Q scores , and response and remission rates demonstrated similar improvement for vortioxetine and venlafaxine XR , with remission rates ( MADRS 10 ) of 43.1 % ( vortioxetine ) versus 41.4 % ( venlafaxine XR ) ( LOCF ) .
-RESULTS	Fewer vortioxetine than venlafaxine XR patients withdrew for any reason ( 18.0 % versus 27.4 % ) or for adverse events ( 6.6 % versus 13.7 % ) .
-RESULTS	The most frequent adverse events ( 5 % ) for both treatments were nausea , dizziness , headache , and dry mouth .
-RESULTS	In addition , accidental overdose , decreased appetite , constipation and insomnia were reported by ( 5 % ) of patients treated with venlafaxine XR .
-CONCLUSIONS	The inclusion and exclusion criteria may limit the generalizability of the study .
-CONCLUSIONS	Since patients with a history of lack of response to venlafaxine XR were excluded from this study , there is a selection bias in favor of venlafaxine XR .
-CONCLUSIONS	Vortioxetine was at least as efficacious as venlafaxine XR and was safe and better tolerated than venlafaxine XR .
-
-###24733807
-OBJECTIVE	Empiric antibiotic monotherapy is considered the standard of treatment for febrile neutropenic patients with cancer , but this approach may be inadequate because of the increasing prevalence of infections caused by multidrug resistant ( MDR ) bacteria .
-METHODS	In this multicenter , open-label , randomized , superiority trial , adult , febrile , high-risk neutropenic patients ( FhrNPs ) with hematologic malignancies were randomly assigned to receive piperacillin/tazobactam ( 4.5 g intravenously every 8 hours ) with or without tigecycline ( 50 mg intravenously every 12 hours ; loading dose 100 mg ) .
-METHODS	The primary end point was resolution of febrile episode without modifications of the initial allocated treatment .
-RESULTS	Three hundred ninety FhrNPs were enrolled ( combination/monotherapy , 187/203 ) and were included in the intention-to-treat analysis ( ITTA ) .
-RESULTS	The ITTA revealed a successful outcome in 67.9 % v 44.3 % of patients who had received combination therapy and monotherapy , respectively ( 127/187 v 90/203 ; absolute difference in risk ( adr ) , 23.6 % ; 95 % CI , 14 % to 33 % ; P < .001 ) .
-RESULTS	The combination regimen proved better than monotherapy in bacteremias ( adr , 32.8 % ; 95 % CI , 19 % to 46 % ; P < .001 ) and in clinically documented infections ( adr , 36 % ; 95 % CI , 9 % to 64 % ; P < .01 ) .
-RESULTS	Mortality and number of adverse effects were limited and similar in the two groups .
-CONCLUSIONS	The combination of piperacillin/tazobactam and tigecycline is safe , well tolerated , and more effective than piperacillin/tazobactam alone in febrile , high-risk , neutropenic hematologic patients with cancer .
-CONCLUSIONS	In epidemiologic settings characterized by a high prevalence of infections because of MDR microorganisms , this combination could be considered as one of the first-line empiric antibiotic therapies .
-
-###24899755
-OBJECTIVE	To compare pregabalin versus placebo and pramipexole for reducing restless legs syndrome ( RLS ) - related sleep disturbance .
-METHODS	Randomized , double-blinded , crossover trial .
-METHODS	Twenty-three US sleep centers .
-METHODS	Eighty-five individuals with moderate to severe idiopathic RLS and associated sleep disturbance .
-METHODS	Participants were randomized across 6 treatment sequences comprising three 4-week periods on pregabalin 300 mg/day ( n = 75 ) , pramipexole 0.5 mg/day ( n = 76 ) , or placebo ( n = 73 ) .
-RESULTS	Polysomnography was conducted over 2 nights at the end of each period .
-RESULTS	Primary ( wake after sleep onset [ WASO ] , pregabalin vs placebo ) and key secondary endpoints were analyzed for statistical significance , with descriptive statistics for other endpoints .
-RESULTS	Pregabalin improved sleep maintenance , demonstrated by reductions in WASO ( -27.1 min vs placebo [ P < 0.0001 ] ; -26.9 vs pramipexole ) and number of awakenings after sleep onset ( -2.7 vs placebo ; -7.9 vs pramipexole [ P < 0.0001 ] ) by polysomnography , and an increase in subjective total sleep time ( 30.8 min vs placebo [ P < 0.0001 ] ; 26.8 vs pramipexole ) .
-RESULTS	Pregabalin also increased slow wave sleep duration ( 20.9 min vs placebo ; 32.1 vs pramipexole [ P < 0.0001 ] ) .
-RESULTS	Reduction in periodic limb movement arousal index ( PLMAI ) with pregabalin was similar to pramipexole and greater than placebo ( -3.7 PLMA/h [ P < 0.0001 ] ) , although reduction in total PLM in sleep was less than for pramipexole .
-CONCLUSIONS	This study demonstrated improvements in objective and subjective measures of sleep maintenance and sleep architecture with pregabalin compared with placebo and pramipexole .
-CONCLUSIONS	Effects of pregabalin on periodic limb movement arousal index were comparable to pramipexole .
-BACKGROUND	ClinicalTrials.gov identifier , NCT00991276 ; http://clinicaltrials.gov/show/NCT00991276 .
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-###25042266
-OBJECTIVE	Limited data exist on radial access in carotid artery stenting .
-OBJECTIVE	This multicentre prospective randomised study was performed to compare the outcome and complication rates of transradial and transfemoral carotid artery stenting .
-RESULTS	The clinical and angiographic data of 260 consecutive patients with high risk for carotid endarterectomy , treated between 2010 and 2012 by carotid stenting with cerebral protection , were evaluated .
-RESULTS	Patients were randomised to transradial ( n = 130 ) or transfemoral ( n = 130 ) groups and several parameters were evaluated .
-RESULTS	Primary combined endpoint : major adverse cardiac and cerebral events , rate of access-site complications .
-RESULTS	Secondary endpoints : angiographic outcome of the procedure , fluoroscopy time and X-ray dose , procedural time , crossover rate to another puncture site and hospitalisation in days .
-RESULTS	Procedural success was achieved in all 260 patients ( 100 % ) , the crossover rate was 10 % in the TR and 1.5 % in the TF group ( p < 0.05 ) .
-RESULTS	A major access-site complication was encountered in one patient ( 0.9 % ) in the TR group and in one patient ( 0.8 % ) in the TF group ( p = ns ) .
-RESULTS	The incidence of major adverse cardiac and cerebral events was 0.9 % in the TR and 0.8 % in the TF group ( p = ns ) .
-RESULTS	Procedure time ( 1,620 [ 1,230-2 ,100 ] vs. 1,500 [ 1,080-2 ,100 ] sec , p = ns ) and fluoroscopy time ( 540 [ 411-735 ] vs. 501 [ 378-702 ] sec , p = ns ) were not significantly different , but the radiation dose was significantly higher in the TR group ( 195 [ 129-274 ] vs. 148 [ 102-237 ] Gy * cm2 , p < 0.05 ) by per-protocol analysis .
-RESULTS	Hospitalisation days were significantly lower in the TR group ( 1.170.40 vs. 1.250.45 , p < 0.05 ) .
-RESULTS	By intention-to-treat analysis there was a significantly higher radiation dose in the TR group ( 195 [ 130-288 ] vs. 150 [ 104-241 ] , p < 0.05 ) , but no difference in major events ( 0.9 vs. 0.8 , p = ns ) and length of hospitalisation in days ( 1.42.6 vs. 1.250.45 , p = ns ) .
-CONCLUSIONS	The transradial approach for carotid artery stenting is safe and efficacious ; however , the crossover rate is higher with transradial access .
-CONCLUSIONS	There are no differences in the total procedure duration and fluoroscopy time between the two approaches but the radiation dose is significantly higher in the radial group , and the hospitalisation is shorter with the use of transradial access by per-protocol analysis .
-CONCLUSIONS	By evaluating the patient data according to intention-to-treat analysis we found no difference in major adverse events and hospitalisation .
-CONCLUSIONS	In both groups , vascular complications rarely occurred .
-
-###24620920
-OBJECTIVE	Here , we evaluated the safety and immunogenicity of hepatitis B virus ( HBV ) DNA vaccine , HB-110 , in mice and Korean patients with chronic hepatitis B ( CHB ) undergoing adefovir dipivoxil ( ADV ) treatment .
-METHODS	For animal study , mice ( BALB/c or HBV transgenic ) were immunized with mHB-110 , and T-cell and antibody responses were evaluated .
-METHODS	For clinical study , 27 patients randomly received either ADV alone or ADV in combination with HB-110 .
-METHODS	Liver function tests , serum HBV DNA levels and the presence of HBeAg/anti-HBe were analysed .
-METHODS	T-cell responses were estimated by ELISPOT and FACS analysis .
-RESULTS	mHB-110 induced higher T-cell and antibody responses than mHB-100 in mice .
-RESULTS	No adverse effects were observed by HB-110 cotreated with ADV. HBV-specific T-cell responses were induced in a portion of patients in medium to high dose of HB-110 .
-RESULTS	Interestingly , HB-110 exhibited positive effects on ALT normalization and maintenance of HBeAg seroconversion .
-RESULTS	One patient , who received high dose of HB-110 exhibited HBeAg seroconversion during vaccination , which correlated with vaccine-induced T-cell responses without ALT elevation .
-CONCLUSIONS	HB-110 was safe and tolerable in CHB patients .
-CONCLUSIONS	In contrast to results in animal models , HB-110 in Korean patients exhibited weaker capability of inducing HBV-specific T-cell responses and HBeAg seroconversion than HB-100 in Caucasian patients .
-CONCLUSIONS	As Asian patients , who are generally infected via vertical transmission , appeared to have higher level of immune tolerance than Caucasian , novel approaches for breaking immune tolerance rather than enhancing immunogenicity may be more urgently demanded to develop effective therapeutic HBV DNA vaccines .
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-###25127208
-BACKGROUND	We assessed the efficacy , safety , and tolerability of ponesimod , an oral , selective , reversible modulator of sphingosine 1-phosphate receptor 1 , in patients with moderate to severe chronic plaque psoriasis .
-METHODS	Between Sept 22 , 2010 , and Oct 24 , 2012 , patients with psoriasis area and severity index ( PASI ) scores higher than 10 were enrolled into this multicentre double-blind , phase 2 study .
-METHODS	They received 20 mg or 40 mg ponesimod or placebo once daily for 16 weeks .
-METHODS	Those with at least 50 % reduction in PASI score at 16 weeks and who were receiving ponesimod were rerandomised to receive maintenance ponesimod therapy or placebo until week 28 .
-METHODS	The primary endpoint was reduction in PASI score from baseline of at least 75 % ( PASI75 ) at week 16 .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT01208090 .
-RESULTS	Of 326 patients initially randomised ( 20 mg ponesimod n = 126 , 40 mg ponesimod n = 133 , and placebo n = 67 ) PASI75 was achieved at week 16 in 58 ( 460 % ) , 64 ( 481 % ) , and nine ( 134 % ) , respectively .
-RESULTS	The treatment effect was significant for the two ponesimod doses ( both p < 00001 ) .
-RESULTS	Of 219 patients who entered the maintenance period , PASI75 was achieved by week 28 in 35 ( 714 % ) of 49 who continued on 20 mg ponesimod and 41 ( 774 % ) of 53 on 40 mg ponesimod , and in 19 ( 422 % ) of 45 who swapped from 20 mg to placebo and 19 ( 404 % ) of 47 from 40 mg to placebo .
-RESULTS	Ponesimod was associated with dyspnoea , raised liver enzyme concentrations , and dizziness .
-CONCLUSIONS	Significant clinical benefit was seen at week 16 that increased with maintenance therapy .
-BACKGROUND	Actelion Pharmaceuticals .
-
-###24889819
-OBJECTIVE	We have previously reported excellent cecal intubation rates using a short double-balloon endoscope in patients with a history of incomplete colonoscopy .
-OBJECTIVE	However , data on the endoscopic treatment of colorectal tumors using a double-balloon endoscope are limited .
-OBJECTIVE	The aim of the present study was to evaluate the efficacy and safety of endoscopic intervention of colorectal tumors using a short double-balloon endoscope .
-METHODS	We analyzed data from a multicenter , prospective study on 110 patients ( 62 men , median age 66.5 years ) who underwent total colonoscopy after incomplete colonoscopy to assess the characteristics of colorectal tumors , endoscopic interventions , and complications .
-RESULTS	In all , 113 colorectal tumors were detected in 55 patients ; 109 of the tumors were adenomas ( 24 advanced adenomas ) and two each were intramucosal and advanced cancers .
-RESULTS	Locations of the lesions were eight in the cecum , 30 in the ascending colon , 18 in the transverse colon , 12 in the descending colon , 34 in the sigmoid colon , five in the rectosigmoid and six in the rectum .
-RESULTS	Average tumor diameter was 6.86.3 mm .
-RESULTS	Fifty-nine polypectomies , 22 endoscopic mucosal resections , four hot biopsies , and six cold biopsies were done .
-RESULTS	All endoscopic interventions were successfully completed and no complications were noted .
-RESULTS	Two advanced cancers were located in the ascending colon and only a double-balloon endoscope could reach them to take a biopsy sample .
-CONCLUSIONS	Double-balloon endoscopy is effective and safe for endoscopic intervention of colorectal tumors , irrespective of the location , in patients after incomplete colonoscopy .
-
-###25982133
-BACKGROUND	The commonality between chronic conditions that are treated with low-dose ketamine , such as specific chronic pain conditions , depression , and post-traumatic stress disorder , can be found in relation to the stress system , particularly the hypothalamus-pituitary-adrenal axis .
-BACKGROUND	In this study we assess the effect of ketamine on the stress system by measuring plasma and saliva cortisol production during and following exposure to low-dose ketamine .
-METHODS	In a double-blind , randomized , placebo-controlled study , the influence of subanaesthetic ketamine ( 0.29 mg kg ( -1 ) h ( -1 ) for 1 h , followed by 0.57 mg kg ( -1 ) h ( -1 ) for another hour ) was studied with repeated plasma and saliva cortisol samples in 12 healthy male volunteers .
-METHODS	A pharmacokinetic-pharmacodynamic model was used to describe the circadian rhythm-dependent ketamine-induced production of cortisol .
-RESULTS	The endogenous mean baseline cortisol production was 7.9 ( SE 1.5 ) nM min ( -1 ) .
-RESULTS	Consistent with the circadian rhythm , cortisol production decayed by 1.25 nM min ( -1 ) h ( -1 ) .
-RESULTS	Ketamine doubled the cortisol production at a concentration of 165 ( SE 35 ) ng ml ( -1 ) .
-RESULTS	The salivary cortisol concentration closely mirrored the plasma concentration and was exponentially related to the plasma concentration with , at 100 ng ml ( -1 ) ketamine , a saliva : plasma ratio of 0.036 ( se 0.006 ) .
-CONCLUSIONS	Ketamine has an appreciable effect on cortisol production .
-CONCLUSIONS	This may impact on critical physiological and psychological functions .
-BACKGROUND	This study was registered in the Dutch Trial Register under number NTR2717 at www.trialregister.nl .
-
-###24630956
-OBJECTIVE	The purpose of this randomized controlled study was to compare knee stability , kneeling pain , harvest site pain , sensitivity loss , and subjective clinical outcome after primary anterior cruciate ligament ( ACL ) reconstruction with either bone-patellar tendon-bone ( BPTB ) or quadriceps tendon-bone ( QTB ) autografts in a noninferiority study design .
-METHODS	From 2005 to 2009 , a total of 51 patients were included in the present study .
-METHODS	Inclusion criteria were isolated ACL injuries in adults .
-METHODS	Twenty-five patients were randomized to BPTB grafts and 26 to QTB grafts .
-METHODS	An independent examiner performed follow-up evaluations 1 and 2 years postoperatively .
-METHODS	Anteroposterior knee laxity was measured with a KT-1000 arthrometer ( MEDmetric , San Diego , CA ) .
-METHODS	Anterior knee pain was assessed clinically and by knee-walking ability .
-METHODS	Knee Injury and Osteoarthritis Outcome Score ( KOOS ) and subjective International Knee Documentation Committee ( IKDC ) score were used for patient-evaluated outcome .
-RESULTS	Anterior knee laxity was equal between the 2 groups with KT-1000 values of 1.1 1.4 mm and 0.8 1.7 mm standard deviation ( SD ) at follow-up in QTB and BPTB groups , respectively ( P = .65 ) , whereas positive pivot shift test results were seen less frequently ( 14 % compared with 38 % , respectively ; P = .03 ) .
-RESULTS	Anterior kneeling pain , evaluated by the knee walking ability test , was significantly less in the QTB group , with only 7 % of patients grading knee walking as difficult or impossible compared with 34 % in the BPTB group .
-RESULTS	At 1 and 2 years ' follow-up , there was no difference between the 2 groups in subjective patient-evaluated outcome .
-RESULTS	The IKDC score was 75 13 patients and 76 16 SD at 1-year follow-up in QTB and BPTB groups , respectively ( P = .78 ) .
-RESULTS	At 2 years , 12 patients were lost to follow-up , resulting in 18 in the BPTB group and 21 in the QTB group .
-CONCLUSIONS	The use of the QTB graft results in less kneeling pain , graft site pain , and sensitivity loss than seen with BPTB grafts ; however , similar anterior knee stability and subjective outcomes are seen .
-CONCLUSIONS	The results of this study show that QTB is a viable option for ACL reconstruction .
-METHODS	Level II , randomized controlled clinical trial .
-
-###25362221
-BACKGROUND	This study was aimed to investigate the effects of raloxifene on intact parathyroid hormone ( PTH ) level and bone mineral density ( BMD ) for 8 months in women on hemodialysis and women with chronic kidney disease stage 5 not dependent on dialysis to determine its effect on secondary hyperparathyroidism and osteoporosis .
-METHODS	Fifty-one women on hemodialysis and 9 with chronic kidney disease stage 5 were randomly assigned to receive oral raloxifene , 60 mg/d , or placebo for 8 months .
-METHODS	Baseline blood determinations and BMD were done and repeated after 8 months .
-METHODS	Serum levels of total calcium , phosphorus , alkaline phosphatase , and intact PTH were measured .
-RESULTS	Serum levels of intact PTH significantly decreased in both groups , and there was no difference between the two groups after 8 months ( P = .37 ) .
-RESULTS	Serum phosphorus levels also decreased by 1.8 % in the two groups .
-RESULTS	After 8 months of treatment , the BMD of the lumbar spine and femural neck decreased by 1.9 % in the control group , while an increase in BMD was observed in the raloxifene group , with an average increase in both BMDs of the lumbar spine and the femural neck by 2 % ( significant in the lumbar spine ; P = .01 ) .
-CONCLUSIONS	Raloxifene has proven to be an effective medication in terms of improving BMD , with no adverse effects .
-CONCLUSIONS	However , it had no effect on controlling hyperparathyroidism in our patients .
-CONCLUSIONS	Long-term studies should be done to investigate the effects of raloxifene in chronic kidney disease and dialysis patients .
-
-###24864639
-OBJECTIVE	To determine whether the addition of 8 mg dexamethasone to axillary brachial plexus block would prolong the duration of sensory and motor block in patients undergoing hand and forearm surgery .
-METHODS	The prospective , randomised , double-blinded study was conducted at the Eskisehir Osmangazi University Medical School , Turkey , from October 2008 to December 2009 .
-METHODS	It comprised 45 American Society of Anaesthesiologists grade I and II patients under elective surgery of the hand and forearm .
-METHODS	The patients were randomly divided into 3 groups : 5 mg/kg of 2 % prilocaine was applied to Group 1 ; 5 mg/kg of 2 % prilocaine +8 mg of dexamethasone ( 2 ml ) was applied to Group 2 ; and 1.5 mg/kg 0.5 % levobupivacaine was applied to Group 3 .
-METHODS	Sensory and motor block onset time as well as the duration of motor and sensory block of those were monitored and recorded .
-METHODS	SPSS 15 was used for statistical analysis .
-RESULTS	Of the 45 patients , 27 ( 60 % ) were men and 18 ( 40 % ) were women .
-RESULTS	There was no significant difference among the groups in terms of demographic data .
-RESULTS	Based on the duration of motor and sensory block , similar periods of time in Group 1 and Group 2 were noted , whereas this period was statistically different and significantly longer in Group 3 ( p < or = 0.001 ) .
-RESULTS	There were no complications encountered .
-CONCLUSIONS	The addition of dexamethasone to prilocaine prolonged the duration of sensory and motor block .
-CONCLUSIONS	It could be used as an effective adjuvant agent .
-CONCLUSIONS	Levobupivacain could be a more appropriate local anaesthetic in postoperative analgesia and prolonged surgical procedures .
-
-###24233244
-OBJECTIVE	To investigate the effect of 16 weeks of aerobic training performed at two different intensities on nitric oxide ( tNOx ) availability and iNOS/nNOS expression , oxidative stress ( OS ) and inflammation in obese humans with or without type 2 diabetes mellitus ( T2DM ) .
-METHODS	Twenty-five sedentary , obese ( BMI > 30 kg/m2 ) males ( 52.8 7.2 years ) ; 12 controls versus 13 T2DM were randomly allocated to four groups that exercised for 30 min , three times per week either at low ( Fat-Max ; 30-40 % VO ( 2max ) ) or moderate ( T ( vent ) ; 55-65 % VO ( 2max ) ) intensity .
-METHODS	Before and after training , blood and muscle samples ( v. lateralis ) were collected .
-RESULTS	Baseline erythrocyte glutathione was lower ( 21.8 2.8 vs. 32.7 4.4 nmol/ml ) and plasma protein oxidative damage and IL-6 were higher in T2DM ( 141.7 52.1 vs. 75.5 41.6 nmol/ml ) .
-RESULTS	Plasma catalase increased in T2DM after T ( vent ) training ( from 0.98 0.22 to 1.96 0.3 nmol/min/ml ) .
-RESULTS	T2DM groups demonstrated evidence of oxidative damage in response to training ( elevated protein carbonyls ) .
-RESULTS	Baseline serum tNOx were higher in controls than T2DM ( 18.68 2.78 vs. 12.34 3.56 mol/l ) .
-RESULTS	Training at T ( vent ) increased muscle nNOS and tNOx in the control group only .
-RESULTS	Pre-training muscle nNOS was higher in controls than in T2DMs , while the opposite was found for iNOS .
-RESULTS	No differences were found after training for plasma inflammatory markers .
-CONCLUSIONS	Exercise training did not change body composition or aerobic fitness , but improved OS markers , especially when performed at T ( vent ) .
-CONCLUSIONS	Non-diabetics responded to T ( vent ) training by increasing muscle nNOS expression and tNOx levels in skeletal muscle while these parameters did not change in T2DM , perhaps due to higher insulin resistance ( unchanged after intervention ) .
-
-###25112084
-OBJECTIVE	To verify the efficacy of Jianpi-xingniao needling therapy on prevention and treatment of motion sickness .
-METHODS	Sixty volunteers of motion sickness were randomized into an acupuncture group and a delayed acupuncture group , 30 cases in each one .
-METHODS	In the acupuncture group , acupuncture was given at Baihui ( GV 20 ) , Sishencong ( EX-HN 1 ) , Neiguan ( PC 6 ) , Zusanli ( ST 36 ) and Hegu ( LI 4 ) .
-METHODS	The needles were retained for 20 min .
-METHODS	The treatment was given twice a week and 10 treatments were required .
-METHODS	In the delayed acupuncture group , acupuncture was postponed , meaning no acupuncture during observation stage .
-METHODS	Graybel scale was adopted to observe the score of symptoms and physical signs of the subjects of motion sickness before and after intervention .
-METHODS	The efficacy was compared between the two groups .
-RESULTS	Twenty-five cases in the acupuncture group and 22 cases in the delayed acupuncture group were included in the statistical analysis .
-RESULTS	The score of symptoms and physical signs of motion sickness was reduced significantly after treatment in the acupuncture group as compared with that before treatment ( 10.12 + / - 3.37 vs 0.92 + / - 0.40 , P < 0.05 ) .
-RESULTS	The score in the acupuncture group was lower apparently than that in the delayed acupuncture group ( 0.92 + / - 0.40 vs 9.86 + / - 2.53 , P < 0.05 ) .
-RESULTS	The difference was not significant before and after treatment in the self-comparison of the delayed acupuncture group ( P > 0.05 ) .
-RESULTS	The total effective rate was 96.0 % ( 24/25 ) in the acupuncture group , which was significantly better than 0.0 % ( 0/22 ) in the delayed acupuncture group ( P < 0.01 ) .
-CONCLUSIONS	Jianpixingniao needling therapy relieves the symptoms of motion sickness in the patients and achieves a better clinical efficacy .
-
-###25118967
-BACKGROUND	Rapid HIV testing in high-risk populations can increase the number of persons who learn their HIV status and avoid spending clinic resources to locate persons identified as HIV infected .
-METHODS	We determined the cost to sexually transmitted disease ( STD ) clinics of point-of-care rapid HIV testing using data from 7 public clinics that participated in a randomized trial of rapid testing with and without brief patient-centered risk reduction counseling in 2010 .
-METHODS	Costs included counselor and trainer time , supplies , and clinic overhead .
-METHODS	We applied national labor rates and test costs .
-METHODS	We calculated median clinic start-up costs and mean cost per patient tested , and projected incremental annual costs of implementing universal rapid HIV testing compared with current testing practices .
-RESULTS	Criteria for offering rapid HIV testing and methods for delivering nonrapid test results varied among clinics before the trial .
-RESULTS	Rapid HIV testing cost an average of US $ 22/patient without brief risk reduction counseling and US $ 46/patient with counseling in these 7 clinics .
-RESULTS	Median start-up costs per clinic were US $ 1100 and US $ 16,100 without and with counseling , respectively .
-RESULTS	Estimated incremental annual costs per clinic of implementing universal rapid HIV testing varied by whether or not brief counseling is conducted and by current clinic testing practices , ranging from a savings of US $ 19,500 to a cost of US $ 40,700 without counseling and a cost of US $ 98,000 to US $ 153,900 with counseling .
-CONCLUSIONS	Universal rapid HIV testing in STD clinics with same-day results can be implemented at relatively low cost to STD clinics , if brief risk reduction counseling is not offered .
-
-###25009161
-BACKGROUND	The risk of persistent tardive dyskinesia ( TD ) was compared in patients with acute psychosis or agitation aged 55 years or older who were treated with olanzapine ( OLZ ) or conventional antipsychotic ( CNV ) drug therapy .
-METHODS	Patients without TD were randomized to treatment with OLZ ( 2.5-20 mg/d ; n = 150 ) or CNV ( dosed per label ; n = 143 ) .
-METHODS	Following a 6-week drug tapering/initiation period , patients without TD were treated with OLZ or CNV for up to 1 year .
-METHODS	The a priori defined primary outcome end point was persistent TD defined as Abnormal Involuntary Movement Scale ( AIMS ) scores = 2 on at least 2 items or 3 on at least 1 item ( items 1-7 ) lasting at least for 1 month ( Criterion A ) .
-METHODS	Post hoc analyses assessed persistent TD meeting the criterion of moderate severity defined as AIMS score 3 on at least 1 item persisting for 1 month ( Criterion B ) and probable TD defined as elevated AIMS scores ( Criterion A or B ) not persisting for 1 month .
-METHODS	Treatment groups were compared using Kaplan-Meier curve with log-rank exact test .
-RESULTS	On average , patients were 78 years of age ; the predominant diagnosis was dementia ( 76.7 % in the OLZ group and 82.5 % in the CNV group ) .
-RESULTS	Approximately , 40.6 % of patients in the CNV group received haloperidol .
-RESULTS	No significant difference in time to developing persistent TD was observed during treatment with OLZ or CNV ( cumulative incidence : OLZ , 2.5 % [ 95 % confidence interval [ 95 % CI ] : 0.5-7 .0 ] ; CNV , 5.5 % [ 95 % CI : 2.1-11 .6 ] , P = .193 ) .
-RESULTS	The exposure-adjusted event rates per 100 person-years were not significantly different between treatment groups : OLZ ( 2.7 ) and CNV ( 6.3 ; ratio : 0.420 ; 95 % CI : 0.068-1 .969 ) .
-RESULTS	Post hoc analyses revealed a significantly lower risk of at least moderately severe persistent TD persisting for 1 month ( P = .012 ) and probable TD not persisting for 1 month ( Criterion A , P = .030 ; Criterion B , P = .048 ) in OLZ-treated patients .
-RESULTS	For those patients without significant extrapyramidal symptoms at baseline , significantly more patients in the CNV treatment group developed treatment-emergent parkinsonism than for patients in the OLZ treatment group ( CNV : 70 % , 35 of 50 patients ; OLZ 44 % , 25 of 57 patients ; P = .011 ) .
-RESULTS	No significant difference between the groups was observed for treatment-emergent akathisia ( CNV : 6 % , 7 of 117 patients ; OLZ : 10 % , 13 of 130 patients ; P = .351 ) .
-CONCLUSIONS	The cumulative incidence of persistent TD was low and the risk of persistent TD did not differ significantly among predominantly older adult patients having dementia with acute psychosis or agitation treated with OLZ or CNV .
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-###25186820
-BACKGROUND	The effect of anaesthesia on postoperative outcome is unclear .
-BACKGROUND	Cardioprotective properties of volatile anaesthetics have been demonstrated experimentally and in haemodynamically stable patients undergoing coronary artery bypass grafting .
-BACKGROUND	Their effects in patients undergoing high-risk cardiac surgery have not been reported .
-METHODS	We performed a multicentre , randomized , parallel group , controlled study among patients undergoing high-risk cardiac surgery ( combined valvular and coronary surgery ) in 2008-2011 .
-METHODS	One hundred subjects assigned to the treatment group received sevoflurane for anaesthesia maintenance , while 100 subjects assigned to the control group received propofol-based total i.v. anaesthesia .
-METHODS	The primary outcome was a composite of death , prolonged intensive care unit ( ICU ) stay , or both .
-METHODS	Thirty day and 1 yr follow-up , focused on mortality , was performed .
-RESULTS	All 200 subjects completed the follow-up and were included in efficacy analyses , conducted according to the intention-to-treat principle .
-RESULTS	Death , prolonged ICU stay , or both occurred in 36 out of 100 subjects ( 36 % ) in the propofol group and in 41 out of 100 subjects ( 41 % ) in the sevoflurane group ; relative risk 1.14 , 95 % confidence interval 0.8-1 .62 ; P = 0.5 .
-RESULTS	No difference was identified in postoperative cardiac troponin release [ 1.1 ( 0.7-2 ) compared with 1.2 ( 0.6-2 .4 ) ng ml ( -1 ) , P = 0.6 ] , 1 yr all-cause mortality [ 11/100 ( 11 % ) compared with 11/100 ( 11 % ) , P = 0.9 ] , re-hospitalizations [ 20/89 ( 22.5 % ) compared with 11/89 ( 12.4 % ) , P = 0.075 ] , and adverse cardiac events [ 10/89 ( 11.2 % ) compared with 9/89 ( 10.1 % ) , P = 0.8 ] .
-CONCLUSIONS	There was no observed beneficial effect of sevoflurane on the composite endpoint of prolonged ICU stay , mortality , or both in patients undergoing high-risk cardiac surgery .
-BACKGROUND	ClinicalTrials.gov : identifier NCT00821262 .
-BACKGROUND	Eudra CT ( 2008-001752-43 ) .
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-###25480782
-BACKGROUND	Characteristics and outcomes of patients with heart failure and reduced ejection fraction receiving care at Veterans Affairs ( VA ) versus non-VA hospitals have not been previously reported .
-RESULTS	In the randomized controlled Beta-blocker Evaluation of Survival Trial ( BEST ; 1995-1999 ) , of the 2707 ( bucindolol = 1353 ; placebo = 1354 ) patients with heart failure and left ventricular ejection fraction 35 % , 918 received care at VA hospitals , of which 98 % ( n = 898 ) were male .
-RESULTS	Of the 1789 receiving care at non-VA hospitals , 68 % ( n = 1216 ) were male .
-RESULTS	Our analyses were restricted to these 2114 male patients .
-RESULTS	VA patients were older with higher symptom and comorbidity burdens .
-RESULTS	There was no significant between-group difference in unadjusted primary end point of 2-year all-cause mortality ( 35 % VA versus 32 % non-VA ; hazard ratio associated with VA hospitals , 1.09 ; 95 % confidence interval , 0.94-1 .26 ) , which remained unchanged after adjustment for age and race ( hazard ratio , 1.00 ; 95 % confidence interval , 0.86-1 .16 ) or multivariable adjustment , including cardiovascular morbidities ( hazard ratio , 0.94 ; 95 % confidence interval , 0.80-1 .10 ) .
-RESULTS	There was no between-group difference in cause-specific mortalities or hospitalizations .
-RESULTS	Chronic kidney disease , pulmonary edema , left ventricular ejection fraction < 20 % , and peripheral arterial disease were significant predictors of mortality for both groups .
-RESULTS	African America race , New York Heart Association class IV symptoms , atrial fibrillation , and right ventricular ejection fraction < 20 % were associated with higher mortality among non-VA hospital patients only ; however , these differences from VA patients were not significant .
-CONCLUSIONS	Patients with heart failure and reduced ejection fraction receiving care at VA hospitals were older and sicker ; yet their risk of mortality and hospitalization was similar to younger and healthier patients receiving care at non-VA hospitals .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00000560 .
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-###24582046
-OBJECTIVE	The aim of this study was to assess the effectiveness and safety of different strategies of ivabradine therapy by comparing the effects on heart rate ( HR ) , blood pressure ( BP ) , and image quality of coronary CT angiography ( CTA ) .
-METHODS	A total of 192 consecutive patients were randomly assigned to 3 groups of oral premedication with ivabradine 15 mg ( single dose ) , 10 mg ( single dose ) , and 5 mg twice daily for 5 days , prospectively .
-METHODS	Patients using HR-lowering drugs and patients with - blockade contraindication were excluded .
-METHODS	The target HR was 65 beats/min .
-METHODS	In addition 5 to 10 mg of intravenous metoprolol was administered to the patients at the CT unit , if required .
-METHODS	The systolic and diastolic blood BP values and the HRs were recorded .
-METHODS	Image quality was assessed for 8 of 15 coronary segments with a 4-point grading scale .
-METHODS	Results were compared with the Kruskal-Wallis test , one-way ANOVA , and 2 test .
-RESULTS	Reductions in mean HR after the treatment were 18 6 , 14 4 , and 17 7 beats/min for groups 1 , 2 , and 3 , respectively .
-RESULTS	With the total additional therapies , 81.3 % , 67.2 % , and 84.3 % of the patients achieved HR < 65 beats/min in groups 1 , 2 , and 3 , respectively .
-RESULTS	The mean BP values before coronary CTA were not significantly changed except for patients in group 2 .
-RESULTS	Unacceptable ( score 0 ) image quality was obtained in only 4.5 % , 10.2 % , and 4.2 % of all the coronary segments , in groups 1 , 2 , and 3 , respectively .
-CONCLUSIONS	Our study indicates that coronary CTA with premedication with oral ivabradine in all 3 strategies is safe and effective in reducing HR , in particular with a - blockade combination .
-CONCLUSIONS	All 3 ivabradine regimes may be an alternative strategy for HR lowering in patients undergoing coronary CTA .
-CONCLUSIONS	Ivabradine 15 mg ( single dose ) and ivabradine 5 mg twice daily for 5 days are superior to the ivabradine 10-mg single-dose regime for HR lowering without adjunctive intravenous - blocker usage .
-
-###24925124
-OBJECTIVE	There has been no systematic investigation of the individual and combined effects of impaired glucose tolerance ( IGT ) and obesity on cognitive function in the absence of ageing .
-OBJECTIVE	The aims were to examine the effects of IGT and increased waist circumference on cognitive function in ostensibly healthy adults , and to investigate whether a low glycaemic load ( GL ) breakfast can attenuate cognitive impairments in these populations .
-RESULTS	Sixty five females aged 30-50 years were classified into one of four groups following waist circumference ( WC ) measurements and an oral glucose tolerance test : NGT/low WC ( n = 25 ) , NGT/high WC ( n = 22 ) , IGT/low WC ( n = 9 ) , IGT/high WC ( n = 9 ) .
-RESULTS	Memory , psychomotor and executive functions were examined 30 and 120 min after consuming low GL , high GL and water breakfasts according to a randomised , crossover , counterbalanced design .
-RESULTS	IGT was associated with impairment of verbal and spatial memory , and psychomotor function relative to females with NGT , independent of waist circumference .
-RESULTS	Increased waist circumference was associated with impairment of verbal memory and executive function relative to females with low WC , independent of IGT .
-RESULTS	Consumption of the LGL breakfast attenuated verbal memory impairment in the IGT/high WC group relative to the HGL breakfast and no energy control .
-CONCLUSIONS	Increased central adiposity and abnormalities in glucose tolerance preceding type 2 diabetes can have demonstrable negative effects on cognitive function , even in ostensibly healthy , middle-aged females .
-CONCLUSIONS	The potential for GL manipulations to modulate glycaemic response and cognitive function in type 2 diabetes and obesity merits further investigation .
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-###25027257
-BACKGROUND	Tracheal intubation with Macintosh laryngoscope is taught to medical students as it is a lifesaving procedure .
-BACKGROUND	However , it is a difficult technique to learn and the consequences of intubation failure are potentially serious .
-BACKGROUND	The Airtraq optical laryngoscope is a relatively novel intubation device , which allows visualization of the glottic plane without alignment of the oral , pharyngeal , and tracheal axes , possessing advantages over Macintosh for novice personnel .
-BACKGROUND	We introduced a teaching mode featured with a progressive evaluation scheme for preparation and performance of tracheal intubation with medical students in this prospective randomized crossover trial who had no prior airway management experience to find the superior one .
-METHODS	Twenty-six medical students of the 8-year programme in the 6th year participated in this trial , when they did their one-week rotation in the department of anaesthesiology .
-METHODS	Each of the students intubated 6 patients , who were scheduled for surgeries under general anaesthesia , each laryngoscope for 3 patients respectively .
-METHODS	One hundred and forty-nine consecutive patients scheduled for surgical procedures requiring tracheal intubation were enrolled .
-METHODS	Patients were randomly allocated to undergo tracheal intubation using Macintosh ( n = 75 ) or Airtraq ( n = 74 ) laryngoscope .
-METHODS	The progressive evaluation scheme was applied to each intubation attempt .
-RESULTS	Intubation success rate was significantly higher in Airtraq group than Macintosh group ( 87.8 % vs. 66.7 % , P < 0.05 ) .
-RESULTS	Duration of glottis exposure was significantly shorter in Airtraq group compared to Macintosh group ( 50 19 s vs. 81 27 s , P < 0.001 ) .
-RESULTS	A grade I Cormack and Lehane glottic view was obtained in 94.6 % of patients in the Airtraq group versus 32 % of patients in the Macintosh group ( P < 0.001 ) .
-RESULTS	Duration of intubation in Airtraq group was significantly shorter ( 68 21 s vs. 96 22 s , P < 0.05 ) compared to Macintosh group .
-CONCLUSIONS	Airtraq laryngoscope is easier to master for novice personnel with a higher intubation success rate and shorter intubation duration compared with the Macintosh laryngoscope .
-BACKGROUND	Trial registration number is ChiCTR-TRC-13003987 , approval date Dec 12 , 2013 .
-
-###24884894
-BACKGROUND	Previously considered as a disease of the affluent , west or urban people and not of public health importance , diabetes mellitus is increasingly becoming a significant cause of morbidity and mortality in sub-Saharan Africa .
-BACKGROUND	However , population-based data to inform prevention , treatment and control are lacking .
-METHODS	Using the WHO STEPwise approach to chronic disease risk factor surveillance , a population-based , nationwide cross-sectional survey was conducted between July and September 2009 on participants aged 25-64 years .
-METHODS	A multi-stage cluster sample design and weighting were used to produce a national representative data for that age range .
-METHODS	Detailed findings on the magnitude of diabetes mellitus and impaired fasting blood glucose are presented in this paper .
-RESULTS	Fasting blood glucose measurement was conducted on 3056 participants ( 70.2 % females , 87.9 % from rural areas ) .
-RESULTS	The age - sex standardised population-based mean fasting blood glucose was 4.3 mmol/L ( 95 % CI 4.1-4 .4 mmol/L ) with no significant differences by age , sex and location ( urban/rural ) .
-RESULTS	The overall prevalence of impaired fasting blood glucose was 4.2 % ( 95 % CI 3.0 % -5.4 % ) .
-RESULTS	Prevalence of impaired blood glucose was higher in men than in women , 5.7 % ( 95 % CI 3.9 % -7.5 % ) vs 2.7 % ( 95 % CI 1.6 % - 3.8 % ) , p < 0.01 .
-RESULTS	In both men and women , prevalence of raised fasting blood glucose or currently on medication for diabetes was 5.6 % ( 95 % CI 2.6 % - 8.5 % ) .
-RESULTS	Although the prevalence of diabetes was higher in men than women , 6.5 % ( 95 % CI 2.6 % -10.3 % ) vs 4.7 % ( 95 % CI 2.4 % -7.0 % ) , in rural than urban , 5.4 % ( 95 % CI 2.4 % -8.4 % ) vs 4.4 % ( 95 % CI 2.8 % -5.9 % ) and in males in rural than males in urban , 6.9 % ( 95 % CI 2.8 % -11.0 % ) vs 3.2 % ( 95 % CI 0.1 % -6.3 % ) , the differences were not statistically significant , p > 0.05 .
-RESULTS	Compared to previous estimates , prevalence of diabetes increased from < 1.0 % in 1960s to 5.6 % in 2009 ( this study ) .
-CONCLUSIONS	High prevalence of impaired fasting blood glucose and diabetes mellitus call for the implementation of primary healthcare approaches such as the WHO package for essential non-communicable diseases to promote healthy lifestyles , early detection , treatment and control .
-
-###25498773
-BACKGROUND	Malaria rapid diagnostic tests ( RDTs ) are a valid alternative to malaria testing with microscopy and are recommended for the testing of febrile patients before prescribing an antimalarial .
-BACKGROUND	There is a need for interventions to support the uptake of RDTs by health workers .
-OBJECTIVE	To evaluate the cost-effectiveness of introducing RDTs with basic or enhanced training in health facilities in which microscopy was available , compared with current practice .
-METHODS	A three-arm cluster randomized trial was conducted in 46 facilities in central and northwest Cameroon .
-METHODS	Basic training had a practical session on RDTs and lectures on malaria treatment guidelines .
-METHODS	Enhanced training included small-group activities designed to change health workers ' practice and reduce the consumption of antimalarials among test-negative patients .
-METHODS	The primary outcome was the proportion of febrile patients correctly treated : febrile patients should be tested for malaria , artemisinin combination therapy should be prescribed for confirmed cases , and no antimalarial should be prescribed for patients who are test-negative .
-METHODS	Individual patient data were obtained from facility records and an exit survey .
-METHODS	Costs were estimated from a societal perspective using project reports and patient exit data .
-METHODS	The analysis used bivariate multilevel modeling and adjusted for imbalance in baseline covariates .
-RESULTS	Incremental cost per febrile patient correctly treated was $ 8.40 for the basic arm and $ 3.71 for the enhanced arm .
-RESULTS	On scale-up , it was estimated that RDTs with enhanced training would save $ 0.75 per additional febrile patient correctly treated .
-CONCLUSIONS	Introducing RDTs with enhanced training was more cost-effective than RDTs with basic training when each was compared with current practice .
-
-###25238874
-BACKGROUND	Functional decline and frailty are common in community dwelling older adults , increasing the risk of adverse outcomes .
-BACKGROUND	Given this , we investigated the prevalence of frailty-associated risk factors and their distribution according to the severity of perceived risk in a cohort of community dwelling older adults , using the Risk Instrument for Screening in the Community ( RISC ) .
-METHODS	A cohort of 803 community dwelling older adults were scored for frailty by their public health nurse ( PHN ) using the Clinical Frailty Scale ( CFS ) and for risk of three adverse outcomes : i ) institutionalisation , ii ) hospitalisation and iii ) death , within the next year , from one ( lowest ) to five ( highest ) using the RISC .
-METHODS	Prior to scoring , PHNs stated whether they regarded patients as frail .
-RESULTS	The median age of patients was 80years ( interquartile range 10 ) , of whom 64 % were female and 47.4 % were living alone .
-RESULTS	The median Abbreviated Mental Test Score ( AMTS ) was 10 ( 0 ) and Barthel Index was 18/20 ( 6 ) .
-RESULTS	PHNs regarded 42 % of patients as frail , while the CFS categorized 54 % ( scoring 5 ) as frail .
-RESULTS	Dividing patients into low-risk ( score one or two ) , medium-risk ( score three ) and high-risk ( score four or five ) using the RISC showed that 4.3 % were considered high risk of institutionalization , 14.5 % for hospitalization , and 2.7 % for death , within one year of the assessment .
-RESULTS	There were significant differences in median CFS ( 4/9 versus 6/9 versus 6/9 , p < 0.001 ) , Barthel Index ( 18/20 versus 11/20 versus 14/20 , p < 0.001 ) and mean AMTS scores ( 9.51 versus 7.57 versus 7.00 , p < 0.001 ) between those considered low , medium and high risk of institutionalisation respectively .
-RESULTS	Differences were also statistically significant for hospitalisation and death .
-RESULTS	Age , gender and living alone were inconsistently associated with perceived risk .
-RESULTS	Frailty most closely correlated with functional impairment , r = -0.80 , p < 0.001 .
-CONCLUSIONS	The majority of patients in this community sample were perceived to be low risk for adverse outcomes .
-CONCLUSIONS	Frailty , cognitive impairment and functional status were markers of perceived risk .
-CONCLUSIONS	Age , gender and social isolation were not and may not be useful indicators when triaging community dwellers .
-CONCLUSIONS	The RISC now requires validation against adverse outcomes .
-
-###24369195
-BACKGROUND	Currently , there is limited data on the prevention of chemotherapy-induced nausea and vomiting ( CINV ) in Indian patients .
-OBJECTIVE	This post hoc study assessed the efficacy and safety of fosaprepitant compared with aprepitant for prevention of CINV in the Indian population .
-OBJECTIVE	A subgroup analysis was performed from data collected in a phase 3 study of intravenous ( IV ) fosaprepitant or oral aprepitant , plus the 5-HT 3 antagonist ondansetron and the corticosteroid dexamethasone , in cisplatin-nave patients with solid malignancies .
-METHODS	Patients scheduled to receive cisplatin ( 70 mg/m 2 ) were administered a single IV dose of fosaprepitant dimeglumine ( 150 mg ) on day 1 or a 3-day dosing regimen of oral aprepitant ( day 1:125 mg , days 2 and 3:80 mg ) with standard doses of ondansetron and dexamethasone .
-METHODS	Patients recorded nausea and/or vomiting episodes and their use of rescue medication and were monitored for adverse events ( AEs ) and tolerability .
-METHODS	Differences in response rates between fosaprepitant and aprepitant were calculated using the Miettinen and Nurminen method .
-RESULTS	In the Indian subpopulation ( n = 372 ) , efficacy was similar for patients in both the fosaprepitant or aprepitant groups ; complete response in the overall , acute , and delayed phases and no vomiting in all phases were approximately 4 percentage points higher in the fosaprepitant group compared with the aprepitant group .
-RESULTS	Fosaprepitant was generally well-tolerated ; common AEs were similar to oral aprepitant .
-CONCLUSIONS	IV fosaprepitant is as safe and effective as oral aprepitant in the Indian subpopulation and offers an alternative to the oral formulation .
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-###24281396
-BACKGROUND	Collaborative stepped care ( CSC ) may be an appropriate model to provide evidence-based treatment for anxiety disorders in primary care .
-METHODS	In a cluster randomised controlled trial , the effectiveness of CSC compared to care as usual ( CAU ) for adults with panic disorder ( PD ) or generalised anxiety disorder ( GAD ) in primary care was evaluated .
-METHODS	Thirty-one psychiatric nurses who provided their services to 43 primary care practices in the Netherlands were randomised to deliver CSC ( 16 psychiatric nurses , 23 practices ) or CAU ( 15 psychiatric nurses , 20 practices ) .
-METHODS	CSC was provided by the psychiatric nurses ( care managers ) in collaboration with the general practitioner and a consultant psychiatrist .
-METHODS	The intervention consisted of 3 steps , namely guided self-help , cognitive behavioural therapy and antidepressants .
-METHODS	Anxiety symptoms were measured with the Beck Anxiety Inventory ( BAI ) at baseline and after 3 , 6 , 9 and 12 months .
-RESULTS	We recruited 180 patients with a DSM-IV diagnosis of PD or GAD , of whom 114 received CSC and 66 received usual primary care .
-RESULTS	On the BAI , CSC was superior to CAU [ difference in gain scores from baseline to 3 months : -5.11 , 95 % confidence interval ( CI ) -8.28 to -1.94 ; 6 months : -4.65 , 95 % CI -7.93 to -1.38 ; 9 months : -5.67 , 95 % CI -8.97 to -2.36 ; 12 months : -6.84 , 95 % CI -10.13 to -3.55 ] .
-CONCLUSIONS	CSC , with guided self-help as a first step , was more effective than CAU for primary care patients with PD or GAD .
-
-###24711047
-OBJECTIVE	Optimizing assessments of rate of progression in Parkinson disease ( PD ) is important in designing clinical trials , especially of potential disease-modifying agents .
-OBJECTIVE	To examine the value of measures of impairment , disability , and quality of life in assessing progression in early PD .
-METHODS	Inception cohort analysis of data from 413 patients with early , untreated PD who were enrolled in 2 multicenter , randomized , double-blind clinical trials .
-METHODS	Participants were randomly assigned to 1 of 5 treatments ( 67 received creatine , 66 received minocycline , 71 received coenzyme Q10 , 71 received GPI-1485 , and 138 received placebo ) .
-METHODS	We assessed the association between the rates of change in measures of impairment , disability , and quality of life and time to initiation of symptomatic treatment .
-METHODS	Time between baseline assessment and need for the initiation of symptomatic pharmaceutical treatment for PD was the primary indicator of disease progression .
-RESULTS	After adjusting for baseline confounding variables with regard to the Unified Parkinson 's Disease Rating Scale ( UPDRS ) Part II score , the UPDRS Part III score , the modified Rankin Scale score , level of education , and treatment group , we assessed the rate of change for the following measurements : the UPDRS Part II score ; the UPDRS Part III score ; the Schwab and England Independence Scale score ( which measures activities of daily living ) ; the Total Functional Capacity scale ; the 39-item Parkinson 's Disease Questionnaire , summary index , and activities of daily living subscale ; and version 2 of the 12-item Short Form Health Survey Physical Summary and Mental Summary .
-RESULTS	Variables reaching the statistical threshold in univariate analysis were entered into a multivariable Cox proportional hazards model using time to symptomatic treatment as the dependent variable .
-RESULTS	More rapid change ( ie , worsening ) in the UPDRS Part II score ( hazard ratio , 1.15 [ 95 % CI , 1.08-1 .22 ] for 1 scale unit change per 6 months ) , the UPDRS Part III score ( hazard ratio , 1.09 [ 95 % CI , 1.06-1 .13 ] for 1 scale unit change per 6 months ) , and the Schwab and England Independence Scale score ( hazard ratio , 1.29 [ 95 % CI , 1.12-1 .48 ] for 5 percentage point change per 6 months ) was associated with earlier need for symptomatic therapy .
-CONCLUSIONS	AND RELEVANCE In early PD , the UPDRS Part II score and Part III score and the Schwab and England Independence Scale score can be used to measure disease progression , whereas the 39-item Parkinson 's Disease Questionnaire and summary index , Total Functional Capacity scale , and the 12-item Short Form Health Survey Physical Summary and Mental Summary are not sensitive to change .
-BACKGROUND	clinicaltrials.gov Identifiers : NCT00063193 and NCT00076492 .
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-###24411480
-BACKGROUND	To examine the effects of complex cognitive ( mahjong ) and physical ( Tai Chi ) activities on dementia severity in nursing home residents with dementia .
-METHODS	Cluster-randomized open-label controlled design .
-METHODS	110 residents were randomized by nursing home into three conditions : mahjong , Tai Chi , and simple handicrafts ( control ) .
-METHODS	Activities were conducted three times a week for 12 weeks .
-METHODS	Clinical Dementia Rating ( CDR ) was taken at 0 ( baseline ) , 3 ( post-treatment ) , 6 , and 9 months .
-METHODS	The outcome measure was CDR sum-of-box , which is a composite measure of both cognitive and functional deterioration in dementia .
-RESULTS	Intent-to-treat analyses were performed using multilevel regression models .
-RESULTS	Apolipoprotein E 4 allele and education were included as covariates .
-RESULTS	Neither treatments had effects on the cognitive and functional components of the CDR , but mahjong had a significant interaction with time on the CDR sum-of-box total , suggesting a slower rate of global deterioration in the mahjong group as compared with the control group .
-CONCLUSIONS	Mahjong led to a gradual improvement in global functioning and a slightly slower rate of dementia progression over time .
-CONCLUSIONS	The effect was generalized and was not specific to cognition or daily functioning .
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-###24430407
-BACKGROUND	There are limited treatment options for tissue restoration and the prevention of degenerative changes in the knee .
-BACKGROUND	Stem cells have been a focus of intense preclinical research into tissue regeneration but limited clinical investigation .
-BACKGROUND	In a randomized , double-blind , controlled study , the safety of the intra-articular injection of human mesenchymal stem cells into the knee , the ability of mesenchymal stem cells to promote meniscus regeneration following partial meniscectomy , and the effects of mesenchymal stem cells on osteoarthritic changes in the knee were investigated .
-METHODS	A total of fifty-five patients at seven institutions underwent a partial medial meniscectomy .
-METHODS	A single superolateral knee injection was given within seven to ten days after the meniscectomy .
-METHODS	Patients were randomized to one of three treatment groups : Group A , in which patients received an injection of 50 10 allogeneic mesenchymal stem cells ; Group B , 150 10 allogeneic mesenchymal stem cells ; and the control group , a sodium hyaluronate ( hyaluronic acid/hyaluronan ) vehicle control .
-METHODS	Patients were followed to evaluate safety , meniscus regeneration , the overall condition of the knee joint , and clinical outcomes at intervals through two years .
-METHODS	Evaluations included sequential magnetic resonance imaging ( MRI ) .
-RESULTS	No ectopic tissue formation or clinically important safety issues were identified .
-RESULTS	There was significantly increased meniscal volume ( defined a priori as a 15 % threshold ) determined by quantitative MRI in 24 % of patients in Group A and 6 % in Group B at twelve months post meniscectomy ( p = 0.022 ) .
-RESULTS	No patients in the control group met the 15 % threshold for increased meniscal volume .
-RESULTS	Patients with osteoarthritic changes who received mesenchymal stem cells experienced a significant reduction in pain compared with those who received the control , on the basis of visual analog scale assessments .
-CONCLUSIONS	There was evidence of meniscus regeneration and improvement in knee pain following treatment with allogeneic human mesenchymal stem cells .
-CONCLUSIONS	These results support the study of human mesenchymal stem cells for the apparent knee-tissue regeneration and protective effects .
-
-###25648901
-BACKGROUND	Amyotrophic lateral sclerosis patients have significant respiratory abnormalities with incomplete understanding of respiratory control .
-BACKGROUND	This study analyzes electromyography ( EMG ) of the diaphragm ( dEMG ) using implanted diaphragm pacing ( DP ) electrodes .
-METHODS	Retrospective analysis of dEMG data were obtained during Institutional Review Board and US Food and Drug Administration approved trials .
-METHODS	The electrodes were used to analyze epochs of dEMG during multiple respiratory cycles .
-RESULTS	Fifty-three patients were implanted .
-RESULTS	Thirty-six had bilateral dEMG assessments , 18 had continuous overnight readings with pulse oximetry , and 19 had serial analysis .
-RESULTS	Several findings revealed an alteration in the central respiratory drive including central apnea , hypoventilation , and hypercarbia .
-RESULTS	The electrodes showed unilateral dysfunction and demonstrated noninvasive ventilation suppression of diaphragm activity .
-RESULTS	DP can be used for serial monitoring , to decrease hypercarbia , improve sleep , and decrease atrophy .
-CONCLUSIONS	Multiple abnormalities of respiratory control can be seen in amyotrophic lateral sclerosis patients using dEMG through therapeutic DP electrodes .
-CONCLUSIONS	DP is used to overcome instability of respiratory control when there are intact diaphragm motor units leading to improved survival .
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-###24593225
-BACKGROUND	Atherosclerotic cardiovascular disease ( CVD ) is the most common cause of morbidity and mortality among hemodialysis ( HD ) patients .
-BACKGROUND	It has been attributed , among other causes , to hypertension and dyslipidemia .
-BACKGROUND	The aim of the present study was to investigate the effect of a year-long consumption of Pomegranate juice ( PJ ) , on two traditional cardiovascular ( CV ) risk factors : hypertension and lipid profile , as well as on cardiovascular events .
-METHODS	101 HD patients were randomized to receive 100cc of PJ ( 0.7 mM polyphenols ) or matching placebo juice , three times a week for one year .
-METHODS	The primary endpoints were traditional CV risk factors ; blood pressure and lipid profile .
-METHODS	Systolic , diastolic and pulse pressure , plasma levels of triglycerides ( TG ) , high density lipoprotein ( HDL ) , low density lipoprotein ( LDL ) and total cholesterol were monitored quarterly during the study year .
-METHODS	Secondary endpoint was incidence of cardiovascular events .
-RESULTS	PJ consumption yielded a significant time response improvement in systolic blood pressure , pulse pressure , triglycerides and HDL level ; an improvement that was not observed in the placebo intake group .
-RESULTS	These beneficial outcomes were more pronounced among patients with hypertension , high level of triglycerides and low levels of HDL .
-CONCLUSIONS	Regular PJ consumption by HD patients reduced systolic blood pressure and improved lipid profile .
-CONCLUSIONS	These favorable changes may reduce the accelerated atherosclerosis and high incidence of CVD among HD patients .
-BACKGROUND	ClinicalTrials.gov registry , Identifier number : NCT00727519 .
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-###24256699
-OBJECTIVE	Statins and calcium channel blockers have been proven beneficial toward improvement of endothelial function .
-OBJECTIVE	The aim of this study was to compare the effect of combination therapy of statin and calcium channel blocker with solo treatment in patients with cardiac syndrome X.
-RESULTS	Sixty-eight patients with cardiac syndrome X were divided randomly into three groups : fluvastatin ( 40 mg/day , n = 23 ) , diltiazem ( 90 mg/day , n = 22 ) , and combination of fluvastatin ( 40 mg/day ) and diltiazem ( 90 mg/day , n = 23 ) .
-RESULTS	At the end of 90 days , the coronary flow reserve was improved in the three groups ( fluvastatin-treated group : 23.2 % ; diltiazem-treated group : 12.4 % ; fluvastatin + diltiazem-treated group : 29.1 % , all P < 0.05 ) .
-RESULTS	The time to 1 mm ST segment depression increased significantly in the fluvastatin-treated group ( from 24197 to 410140 s , P < 0.05 ) , the diltiazem-treated group ( from 25891 to 392124 s , P < 0.05 ) , and the fluvastatin + diltiazem-treated group ( from 250104 to 446164 s , P < 0.05 ) .
-RESULTS	The improvement in coronary flow reserve and prolonged time to 1 mm ST segment depression in the combination treatment group were more remarkable than in those who received monotherapy .
-RESULTS	Combination therapy also induced a significant increase ( 35.6 % , P < 0.05 ) in nitric oxide and an apparent reduction ( 48.7 % , P < 0.05 ) in endothelin-1 .
-CONCLUSIONS	Combination treatment with fluvastatin and diltiazem is more effective on endothelial function and exercise tolerance than solo treatment in patients with cardiac syndrome X.
-CONCLUSIONS	The benefits of these drugs may be related to the elevation of nitric oxide and reduction of endothelin-1 .
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-###24393120
-BACKGROUND	Pulmonary embolism ( PE ) is the third most common cause of death from cardiovascular disease .
-BACKGROUND	Computed-tomographic pulmonary angiography ( CTPA ) is an accurate and safe test for diagnosing PE .
-BACKGROUND	The aim of this retrospective analysis was to evaluate the effects on image quality ( IQ ) of electrocardiogram ( ECG ) gating during CTPA .
-METHODS	Fifty consecutive patients presenting for CTPA were included in the study .
-METHODS	A single acquisition was performed , resulting in two reconstructions : one at 75 % of the R-R interval and the other without ECG influence .
-METHODS	IQ evaluation was undertaken by two radiologists , focusing on respiratory and cardiac motion , image noise , low-contrast resolution , vessel and lung clarity , contrast media opacification and artefacts .
-METHODS	Various regions of the lungs and vasculature were evaluated , and IQ scores were statistically compared .
-RESULTS	For the ECG-tagged reconstructions , IQ was noted to be better overall with regard to vessel clarity ( P < 0.05 ) and cardiac motion ( P < 0.05 ) , while lung clarity was better only in the left lower zone ( P < 0.05 ) .
-RESULTS	IQ was better with regard to image noise ( P < 0.05 ) and low-contrast resolution ( P < 0.05 ) in the non-ECG-tagged reconstructions .
-RESULTS	No statistical IQ difference between the two types of reconstruction was noted with regard to respiratory motion , contrast media opacification or presence of artefacts .
-CONCLUSIONS	The two types of reconstruction provide complementary information for evaluating CTPA results .
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-###25742308
-BACKGROUND	Adaptive support ventilation ( ASV ) is a closed loop mode of mechanical ventilation ( MV ) that provides a target minute ventilation by automatically adapting inspiratory pressure and respiratory rate with the minimum work of breathing on the part of the patient .
-BACKGROUND	The aim of this study was to determine the effect of ASV on total MV duration when compared with pressure assist/control ventilation .
-METHODS	Adult medical patients intubated and mechanically ventilated for > 24 h in a medical ICU were randomized to either ASV or pressure assist/control ventilation .
-METHODS	Sedation and medical treatment were standardized for each group .
-METHODS	Primary outcome was the total MV duration .
-METHODS	Secondary outcomes were the weaning duration , number of manual settings of the ventilator , and weaning success rates .
-RESULTS	Two hundred twenty-nine patients were included .
-RESULTS	Median MV duration until weaning , weaning duration , and total MV duration were significantly shorter in the ASV group ( 67 [ 43-94 ] h vs 92 [ 61-165 ] h , P = .003 ; 2 [ 2-2 ] h vs 2 [ 2-80 ] h , P = .001 ; and 4 [ 2-6 ] days vs 4 [ 3-9 ] days , P = .016 , respectively ) .
-RESULTS	Patients in the ASV group required fewer total number of manual settings on the ventilator to reach the desired pH and Paco2 levels ( 2 [ 1-2 ] vs 3 [ 2-5 ] , P < .001 ) .
-RESULTS	The number of patients extubated successfully on the first attempt was significantly higher in the ASV group ( P = .001 ) .
-RESULTS	Weaning success and mortality at day 28 were comparable between the two groups .
-CONCLUSIONS	In medical patients in the ICU , ASV may shorten the duration of weaning and total MV duration with a fewer number of manual ventilator settings .
-BACKGROUND	ClinicalTrials.gov ; No. : NCT01472302 ; URL : www.clinicaltrials.gov .
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-###24498368
-BACKGROUND	We aim to test the hypothesis that high plasma YKL-40 is associated with short progression-free survival ( PFS ) and overall survival ( OS ) in patients with metastatic colorectal cancer ( mCRC ) treated with first-line oxaliplatin and 5-flourouracil with or without cetuximab .
-METHODS	A total of 566 patients in the NORDIC VII Study were randomized 111 to arm A ( Nordic FLOX ) , arm B ( Nordic FLOX + cetuximab ) , or arm C ( Nordic FLOX + cetuximab for 16 weeks followed by cetuximab alone as maintenance therapy ) .
-METHODS	Pretreatment plasma samples were available from 510 patients .
-METHODS	Plasma YKL-40 was determined by ELISA and dichotomized according to the age-corrected 95 % YKL-40 level in 3130 healthy subjects .
-RESULTS	Pretreatment plasma YKL-40 was elevated in 204 patients ( 40 % ) , and median YKL-40 was higher in patients with mCRC than in healthy subjects ( age adjusted , P < 0.001 ) .
-RESULTS	Patients with elevated YKL-40 had shorter PFS than patients with normal YKL-40 ( 7.5 vs. 8.2 months ; hazard ratio ( HR ) = 1.27 95 % confidence interval ( CI ) 1.05-1 .53 P = 0.013 ) and shorter OS ( 16.8 vs. 23.9 months ; HR = 1.33 , 1.04-1 .69 , P = 0.024 ) .
-RESULTS	Multivariate Cox analysis demonstrated that elevated pretreatment YKL-40 was an independent biomarker of short OS ( HR = 1.12 , 1.01-1 .25 , P = 0.033 ) .
-RESULTS	The ratio of the updated plasma YKL-40 ( i.e. level after 1 , 2 , 8 weeks of treatment , and at end of treatment compared to the baseline level ) was associated with OS ( HR = 1.27 , 1.06-1 .52 , P = 0.011 ) .
-CONCLUSIONS	Plasma YKL-40 is an independent prognostic biomarker in patients with mCRC treated with first-line oxaliplatin-based therapy alone or combined with cetuximab .
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-###24497345
-OBJECTIVE	Intra-myocardial transplantation of CD133 ( + ) bone marrow stem cells ( BMC ) yielded promising results in clinical pilot trials .
-OBJECTIVE	We now performed the double-blinded , randomized , placebo-controlled CARDIO133 trial to determine its impact on left ventricular ( LV ) function and clinical symptoms .
-RESULTS	Sixty patients with chronic ischaemic heart disease and impaired LV function ( left ventricular ejection fraction , LVEF < 35 % ) were randomized to undergo either coronary artery bypass grafting ( CABG ) and injection of CD133 ( + ) BMC in the non-transmural , hypokinetic infarct border zone ( CD133 ) , or CABG and placebo injection ( placebo ) .
-RESULTS	Pre-operative LVEF was 27 6 % in CD133 patients and 26 6 % in placebo patients .
-RESULTS	Outcome was assessed after 6 months , and the primary endpoint was LVEF measured by cardiac magnetic resonance imaging ( MRI ) at rest .
-RESULTS	The incidence of adverse events was similar in both groups .
-RESULTS	There was no difference in 6-min walking distance , Minnesota Living with Heart Failure score , or Canadian Cardiovascular Society ( CCS ) class between groups at follow-up , and New York Heart Association class improved more in the placebo group ( P = 0.004 ) .
-RESULTS	By cardiac MRI , LVEF at 6 months was 33 8 % in the placebo group and 31 7 % in verum patients ( P = 0.3 ) , with an average inter-group difference of -2.1 % ( 95 % CI -6.3 to 2.1 ) .
-RESULTS	Systolic or diastolic LV dimensions at 6 months were not different , either .
-RESULTS	In the CD133 group , myocardial perfusion at rest recovered in more LV segments than in the placebo group ( 9 vs. 2 % , P < 0.001 ) .
-RESULTS	Scar mass decreased by 2.2 5 g in CD133 ( + ) patients ( P = 0.05 ) , but was unchanged in the placebo group ( 0.3 4 g , P = 0.7 ; inter-group difference in change = 2 g ( 95 % CI -1.1 to 5 ) ) .
-RESULTS	By speckle-tracking echocardiography , cell-treated patients showed a better recovery of regional wall motion when the target area was posterior .
-CONCLUSIONS	Although there may be some improvements in scar size and regional perfusion , intra-myocardial injection of CD133 ( + ) BMC has no effect on global LV function and clinical symptoms .
-CONCLUSIONS	Improvements in regional myocardial function are only detectable in patients with posterior infarction , probably because the interventricular septum after anterior infarction is not accessible by trans-epicardial injection .
-BACKGROUND	This trial was registered at http://www.clinicaltrials.gov under NCT00462774 .
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-###25189358
-BACKGROUND	Although adolescent girls are the main population for prophylactic human papillomavirus ( HPV ) vaccines , adult women who remain at risk of cervical cancer can also be vaccinated .
-BACKGROUND	We report data from the interim analysis of the ongoing VIVIANE study , the aim of which is to assess the efficacy , safety , and immunogenicity of the HPV 16/18 AS04-adjuvanted vaccine in adult women .
-METHODS	In this phase 3 , multinational , double-blind , randomised controlled trial , we randomly assigned healthy women older than 25 years to the HPV 16/18 vaccine or control ( 1:1 ) , via an internet-based system with an algorithm process that accounted for region , age stratum , baseline HPV DNA status , HPV 16/18 serostatus , and cytology .
-METHODS	Enrolment was age-stratified , with about 45 % of participants in each of the 26-35 and 36-45 years age strata and 10 % in the 46 years and older stratum .
-METHODS	Up to 15 % of women in each age stratum could have a history of HPV infection or disease .
-METHODS	The primary endpoint was vaccine efficacy against 6-month persistent infection or cervical intraepithelial neoplasia grade 1 or higher ( CIN1 + ) associated with HPV 16/18 .
-METHODS	The primary analysis was done in the according-to-protocol cohort for efficacy , which consists of women who received all three vaccine or control doses , had negative or low-grade cytology at baseline , and had no history of HPV disease .
-METHODS	Secondary analyses included vaccine efficacy against non-vaccine oncogenic HPV types .
-METHODS	Mean follow-up time was 403 months .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT00294047 .
-RESULTS	The first participant was enrolled on Feb 16 , 2006 , and the last study visit for the present analysis took place on Dec 10 , 2010 ; 5752 women were included in the total vaccinated cohort ( n = 2881 vaccine , n = 2871 control ) , and 4505 in the according-to-protocol cohort for efficacy ( n = 2264 vaccine , n = 2241 control ) .
-RESULTS	Vaccine efficacy against HPV 16/18-related 6-month persistent infection or CIN1 + was significant in all age groups combined ( 811 % , 977 % CI 521-940 ) , in the 26-35 years age group ( 835 % , 450-968 ) , and in the 36-45 years age group ( 772 % , 28-969 ) ; no cases were seen in women aged 46 years and older .
-RESULTS	Vaccine efficacy against atypical squamous cells of undetermined significance or greater associated with HPV 16/18 was also significant .
-RESULTS	We also noted significant cross-protective vaccine efficacy against 6-month persistent infection with HPV 31 ( 791 % , 977 % CI 276-959 ) and HPV 45 ( 769 % , 185-956 ] ) Serious adverse events occurred in 285 ( 10 % ) of 2881 women in the vaccine group and 267 ( 9 % ) of 2871 in the control group ; five ( < 1 % ) and eight ( < 1 % ) of these events , respectively , were believed to be related to vaccination .
-CONCLUSIONS	In women older than 25 years , the HPV 16/18 vaccine is efficacious against infections and cervical abnormalities associated with the vaccine types , as well as infections with the non-vaccine HPV types 31 and 45 .
-BACKGROUND	GlaxoSmithKline Biologicals SA .
-
-###24578074
-OBJECTIVE	To describe the predictors of nurse actions in response to a mobile health decision-support system ( mHealth DSS ) for guideline-based screening and management of tobacco use .
-METHODS	Observational design focused on an experimental arm of a randomized , controlled trial .
-METHODS	Acute and ambulatory care settings in the New York City metropolitan area .
-METHODS	14,115 patient encounters in which 185 RNs enrolled in advanced practice nurse ( APN ) training were prompted by an mHealth DSS to screen for tobacco use and select guideline-based treatment recommendations .
-METHODS	Data were entered and stored during nurse documentation in the mHealth DSS and subsequently stored in the study database where they were retrieved for analysis using descriptive statistics and logistic regressions .
-METHODS	Predictor variables included patient gender , patient race or ethnicity , patient payer source , APN specialty , and predominant payer source in clinical site .
-METHODS	Dependent variables included the number of patient encounters in which the nurse screened for tobacco use , provided smoking cessation teaching and counseling , or referred patients for smoking cessation for patients who indicated a willingness to quit .
-RESULTS	Screening was more likely to occur in encounters where patients were female , African American , and received care from a nurse in the adult nurse practitioner specialty or in a clinical site in which the predominant payer source was Medicare , Medicaid , or State Children 's Health Insurance Program .
-RESULTS	In encounters where the patient payer source was other , nurses were less likely to provide tobacco cessation teaching and counseling .
-CONCLUSIONS	mHealth DSS has the potential to affect nurse provision of guideline-based care .
-CONCLUSIONS	However , patient , nurse , and setting factors influence nurse actions in response to an mHealth DSS for tobacco cessation .
-CONCLUSIONS	The combination of a reminder to screen and integration of guideline-based recommendations into the mHealth DSS may reduce racial or ethnic disparities to screening , as well as clinician barriers related to time , training , and familiarity with resources .
-
-###25733652
-BACKGROUND	Although iron supplementation in malaria-free areas mostly reduces infectious morbidity , it can sometimes increase morbidity from infections as a result of the dependence of pathogenic microorganisms on iron .
-BACKGROUND	Supplementation with n-3 ( -3 ) long-chain polyunsaturated fatty acids ( LCPUFAs ) improved morbidity in several human studies .
-BACKGROUND	However , information on the combined effect of iron and n-3 LCPUFA supplementation on infectious morbidity is limited .
-OBJECTIVE	We determined whether n-3 LCPUFAs and iron supplementation , alone or in combination , affected absenteeism and illness in iron-deficient schoolchildren with low fish intake .
-METHODS	A total of 321 South African children ( aged 6-11 y ) with iron deficiency ( ID ) were randomly divided into 4 groups to receive 1 ) iron plus placebo , 2 ) a mixture of docosahexaenoic acid and eicosapentaenoic acid ( DHA/EPA ) plus placebo , 3 ) iron plus DHA/EPA , or 4 ) placebo plus placebo as oral supplements 4 times/wk for 8.5 mo. .
-METHODS	Morbidity was recorded , and iron-status indexes were measured .
-METHODS	The total phospholipid fatty acid composition of peripheral blood mononuclear cell membranes was analyzed in a subsample ( n = 130 ) .
-RESULTS	Iron supplementation increased the number of days with illness when all symptoms were considered ( B : 0.87 ; 95 % CI : 0.71 , 1.03 ) as well as illness that was specifically caused by respiratory symptoms ( B : 1.45 ; 95 % CI : 1.21 , 1.70 ) , whereas DHA/EPA reduced the number of days with illness at school ( B : -0.96 ; 95 % CI : -1.33 , -0.59 ) .
-RESULTS	The increases caused by iron were reduced to the levels seen in the placebo plus placebo group when iron was provided in combination with DHA/EPA as indicated by significant iron DHA/EPA interactions ( both P < 0.001 ) .
-CONCLUSIONS	Iron supplementation increased morbidity ( mostly respiratory ) in iron-deficient South African schoolchildren with low DHA/EPA intake , but when iron was given in combination with DHA/EPA , this effect was prevented .
-
-###25250660
-OBJECTIVE	Anorexia nervosa ( AN ) is a serious disorder with high rates of morbidity and mortality .
-OBJECTIVE	Family-based treatment ( FBT ) is an evidence-based therapy for adolescent AN , but less than half of those who receive this approach recover .
-OBJECTIVE	Hence , it is important to identify other approaches to prevent the development of the chronic form of AN for which there is no known evidence-based treatment .
-OBJECTIVE	To compare FBT with systemic family therapy ( SyFT ) for the treatment of adolescent-onset AN .
-METHODS	Research in Anorexia Nervosa ( RIAN ) is a 2-group ( FBT and SyFT ) randomized trial conducted between September 2005 and April 2012 .
-METHODS	Interviewers were blinded to the treatment condition .
-METHODS	A total of 564 adolescents receiving care at 6 outpatient clinics experienced in the treatment of AN were screened .
-METHODS	Of these , 262 adolescents did not meet the inclusion criteria and 138 declined to participate ; hence , 164 adolescents ( aged 12-18 years ) of both sexes meeting the criteria for Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , AN ( except for amenorrhea ) were enrolled .
-METHODS	Three participants were withdrawn from FBT and 7 were withdrawn from SyFT after serious adverse events occurred .
-METHODS	Two manualized family therapies with 16 one-hour sessions during 9 months .
-METHODS	Family-based therapy focuses on the facilitation of weight gain , whereas SyFT addresses general family processes .
-METHODS	The primary outcomes were percentage of ideal body weight ( IBW ) and remission ( 95 % of IBW ) .
-METHODS	The a priori hypothesis was that FBT would result in faster weight gain early in treatment and at the end of treatment ( EOT ) .
-RESULTS	There were no statistically significant differences between treatment groups for the primary outcome , for eating disorder symptoms or comorbid psychiatric disorders at the EOT or follow-up .
-RESULTS	Remission rates included FBT , 33.1 % at the EOT and 40.7 % at follow-up and SyFT , 25.3 % and 39.0 % , respectively .
-RESULTS	Family-based therapy led to significantly faster weight gain early in treatment , significantly fewer days in the hospital , and lower treatment costs per patient in remission at the EOT ( FBT , $ 8963 ; SyFT , $ 18005 ) .
-RESULTS	An exploratory moderator analysis found that SyFT led to greater weight gain than did FBT for participants with more severe obsessive-compulsive symptoms .
-CONCLUSIONS	The findings of this study suggest that FBT is the preferred treatment for adolescent AN because it is not significantly different from SyFT and leads to similar outcomes at a lower cost than SyFT .
-CONCLUSIONS	Adolescents with more severe obsessive-compulsive symptoms may receive more benefits with SyFT .
-BACKGROUND	clinicaltrials.gov Identifier NCT00610753 .
-
-###24279284
-BACKGROUND	The aim of the present study was to assess the efficacy of structured education in insulin-treated type 2 diabetes mellitus ( T2DM ) patients .
-METHODS	In a 16-week open-label randomized controlled study , 1511 T2DM patients with inadequate responses to two or more oral antidiabetic drugs ( OADs ) for > 3 months ( HbA1c > 7.5 % ) were randomized ( 1:1 ) to either an education group ( structured diabetes education plus insulin therapy ) or a control group ( usual care plus insulin therapy ) .
-METHODS	Both groups discontinued previous OADs ( except biguanides and - glucosidase inhibitors ) and started twice daily injections of 30 % soluble-70 % isophane recombinant insulin .
-METHODS	The primary endpoint was the change in HbA1c from baseline .
-METHODS	Efficacy and safety data were analyzed for within - and between-group differences .
-RESULTS	Of the initial 1511 patients , 1289 completed the study ( 643 in the control group ; 646 in the education group ) .
-RESULTS	At the end of the study , significant reductions in HbA1c versus baseline were evident in both groups , but the reduction was greater in the education group ( 2.16 % vs. 2.08 % ; P < 0.05 ) .
-RESULTS	A higher proportion of patients in the education group achieved target HbA1c levels < 7 % ( 43.81 % vs. 36.86 % ; P < 0.05 ) and 6.5 % ( 28.48 % vs. 22.71 % ; P < 0.05 ) .
-RESULTS	In addition , patients in the education group showed greater increments in scores and improvement in the Morisky Medication Adherence Scale ( P < 0.05 ) .
-RESULTS	The overall incidence of hypoglycemic events was similar in the two groups .
-CONCLUSIONS	Structured education can promote the ability of patients to self-manage and their compliance with medications , thereby achieving better outcomes .
-
-###24461364
-OBJECTIVE	The present study is a comparison of two point-of-care ( POC ) tests as endpoints of protamine titration after CPB .
-OBJECTIVE	The authors hypothesized that using the heparinase-kaolin thromboelastography ( TEG-HK ) R-time difference would more readily identify residual heparin necessitating additional protamine than when using activated coagulation time ( ACT ) .
-OBJECTIVE	The primary endpoint was the between-group difference in protamine dose .
-OBJECTIVE	Whether this approach would lessen postoperative bleeding and sequelae also was investigated .
-METHODS	Single center , blinded , prospective , randomized study .
-METHODS	University teaching hospital .
-METHODS	Eighty-two adult patients for on-pump coronary artery bypass and/or valve surgery .
-METHODS	Patients were randomized .
-METHODS	In the ACT group , protamine was titrated until ACT did not exceed baseline by more than 10 % .
-METHODS	In the TEG group , a TEG-HK R-time difference less than 20 % was targeted .
-METHODS	Protamine was repeated to achieve the endpoints .
-METHODS	Clinicians in the ACT group were blinded to TEG data and vice versa .
-RESULTS	There was no between-group difference in total protamine dose ( 3.9 0.6 and 4.2 0.7 ; 95 % CI of the difference between means : -0.544 to 0.008 mg/kg ; p = 0.057 ) or protamine : heparin ratios ( 1.3:1 and 1.4:1 ; 95 % CI of the difference between means : -0.05 to 0.03 mg/mg ; p = 0.653 ) .
-RESULTS	In the ACT group , 17 % of patients required a second protamine dose , and in the TEG group , 24 % of patients required a second protamine dose .
-RESULTS	No between-group differences in the postoperative transfusion requirements or intensive care unit length of stay were demonstrated .
-CONCLUSIONS	No difference was identified in protamine dosing using either ACT or TEG-HK R-time difference as endpoints .
-CONCLUSIONS	Heparinase TEG may be useful for monitoring heparin reversal .
-
-###24830716
-BACKGROUND	Clinical practice guidelines are considered important instruments to improve quality of care .
-BACKGROUND	However , success is dependent on adherence , which may be improved using peer assessment , a strategy in which professionals assess performance of their peers in a simulated setting .
-OBJECTIVE	The aim of this study was to determine whether peer assessment is more effective than case-based discussions to improve knowledge and guideline-consistent clinical reasoning in the Dutch physical therapy guideline for low back pain ( LBP ) .
-METHODS	A cluster randomized controlled trial was conducted .
-METHODS	Ten communities of practice ( CoPs ) of physical therapists were cluster randomized ( N = 90 ) : 6 CoPs in the peer-assessment group ( n = 49 ) and 4 CoPs in the case-based discussion group ( control group ) ( n = 41 ) .
-METHODS	Both groups participated in 4 educational sessions and used clinical patient cases .
-METHODS	The peer-assessment group reflected on performed LBP management in different roles .
-METHODS	The control group used structured discussions .
-METHODS	Outcomes were assessed at baseline and at 6 months .
-METHODS	The primary outcome measure was knowledge and guideline-consistent reasoning , measured with 12 performance indicators using 4 vignettes with specific guideline-related patient profiles .
-METHODS	For each participant , the total score was calculated by adding up the percentage scores ( 0-100 ) per vignette , divided by 4 .
-METHODS	The secondary outcome measure was reflective practice , as measured by the Self-Reflection and Insight Scale ( 20-100 ) .
-RESULTS	Vignettes were completed by 78 participants ( 87 % ) .
-RESULTS	Multilevel analysis showed an increase in guideline-consistent clinical reasoning of 8.4 % in the peer-assessment group , whereas the control group showed a decline of 0.1 % ( estimated group difference = 8.7 % , 95 % confidence interval = 3.9 to 13.4 ) .
-RESULTS	No group differences were found on self-reflection .
-CONCLUSIONS	The small sample size , a short-term follow-up , and the use of vignettes as a proxy for behavior were limitations of the study .
-CONCLUSIONS	Peer assessment leads to an increase in knowledge and guideline-consistent clinical reasoning .
-
-###25781193
-BACKGROUND	Eczema is one of the most common chronic inflammatory skin diseases , affecting about 20 % of children .
-BACKGROUND	The pathogenic mechanisms of eczema are still not fully understood , and current treatment of moderate-severe eczema is often difficult .
-BACKGROUND	Recently , it has been suggested that Vitamin D plays a key role in this disease , even if mechanisms are only partially known .
-OBJECTIVE	The purpose of our study was to assess the 25-Hydroxyvitamin D serum levels in a pediatric population suffering from chronic eczema ( IgE-mediated and non-IgE-mediated ) , and to correlate these phenotypes with the SCORAD severity and selected clinical and biological parameters .
-OBJECTIVE	Moreover , we aimed to evaluate whether a supplementation of Vitamin D3 could affect the same clinical and laboratory parameters .
-METHODS	89 children with chronic eczema were enrolled in the study .
-METHODS	Severity of eczema was assessed with the SCORAD index .
-METHODS	Past and present history was taken , and patients were divided into two groups according to the state of sensitization .
-METHODS	According to a randomization schedule , the enrolled children were assigned to the following groups : supplementation group , which received a daily oral Vitamin D3 supplementation ( 2000 IUs ) for 3 months ; control group which received no supplementation .
-RESULTS	Vitamin D concentrations in patients with moderate and severe eczema were not statistically different from Vitamin D concentration detected in the serum of patients with mild eczema .
-RESULTS	Furthermore , we did not find any correlation between Vitamin D levels , total IgEs and SCORAD index , both in the Sensitized and in the Not-Sensitized group .
-RESULTS	The Vitamin D3 supplementation did not influence the SCORAD severity or the total IgEs concentration .
-CONCLUSIONS	To our knowledge , our study is the first one that shows no correlation between serum levels of Vitamin D , eczema severity and IgE sensitization in a pediatric population suffering from chronic eczema .
-
-###25444222
-BACKGROUND	Up to 25 % of severely injured patients develop trauma-induced coagulopathy .
-BACKGROUND	To study interventions for this vulnerable population for whom consent can not be obtained easily , the Food and Drug Administration issued regulations for emergency research with an exception from informed consent ( ER-EIC ) .
-BACKGROUND	We describe the community consultation and public disclosure ( CC/PD ) process in preparation for an ER-EIC study , namely the Control Of Major Bleeding After Trauma ( COMBAT ) study .
-METHODS	The CC/PD was guided by the four bioethical principles .
-METHODS	We used a multimedia approach , including one-way communications ( newspaper ads , brochures , television , radio , and web ) and two-way communications ( interactive in-person presentations at community meetings , printed and online feedback forms ) to reach the trials catchment area ( Denver County 's population : 643,000 and the Denver larger metro area where commuters reside : 2.9 million ) .
-METHODS	Particular attention was given to special-interests groups ( eg , Jehovah Witnesses , homeless ) and to Spanish-speaking communities ( brochures and presentations in Spanish ) .
-METHODS	Opt-out materials were available during on-site presentations or via the COMBAT study website .
-RESULTS	A total of 227 community organizations were contacted .
-RESULTS	Brochures were distributed to 11 medical clinics and 3 homeless shelters .
-RESULTS	The multimedia campaign had the potential to reach an estimated audience of 1.5 million individuals in large metro Denver area , the majority via one-way communication and 1900 in two-way communications .
-RESULTS	This resource intensive process cost more than $ 84,000 .
-CONCLUSIONS	The CC/PD process is resource-intensive , costly , and complex .
-CONCLUSIONS	Although the multimedia CC/PD reached a large audience , the effectiveness of this process remains elusive .
-CONCLUSIONS	The templates can be helpful to similar ER-EIC studies .
-
-###25417403
-OBJECTIVE	To assess the clinical curative effect of fuzi-cake-separated moxibustion at Zhongji ( CV 3 ) and Guanyuan ( CV 4 ) for preventing dysuria after internal fixation of lower limb fractures .
-METHODS	Sixty patients conforming to the inclusion standards were randomly divided into a treatment group ( n = 30 ) and a control group ( n = 30 ) .
-METHODS	Fuzi-cake-separated moxibustion was performed at Guanyuan ( CV 4 ) and Zhongji ( CV 3 ) , 20 min at a time , twice a day , for 3 days before operation in the treatment group .
-METHODS	No fuzi-cake-separated moxibustion was performed in the control group .
-METHODS	After treatment , the score for symptoms of first urination , urinary time , urinary volume , 24 h remaining urinary volume , incidence of uroschesis , and rate of controlling dysuria were compared to evaluate the curative effect of preventing post-operative dysuria .
-RESULTS	The score for symptoms of first urination , 24 h remaining urinary volume ( maximum 120 mL vs 250 ml , and less than 10 ml in 24 cases vs 15 cases ) , and the rate of controlling dysuria ( 83.34 % vs 30 % ) were significantly better ( P < 0.05 , P < 0.05 , and P < 0.001 , respectively ) in the treatment compared with the control group .
-RESULTS	There was no statistical difference ( P > 0.05 ) between the two groups in first post-operative urinary time , urinary volume , or incidence of 24 h uroschesis .
-CONCLUSIONS	Fuzi-cake-separated moxibustion at Zhongji ( CV 3 ) and Guanyuan ( CV 4 ) can better prevent post-operative dysuria , effectively promote the functional restoration of the urinary bladder , and control the incidence of post-operative dysuria .
-
-###24628859
-BACKGROUND	Chronic angina is a profoundly symptomatic disease .
-BACKGROUND	We evaluated the relationship between angina frequency and health utility .
-METHODS	We used data from stable angina patients reporting 3 attacks/week enrolled in the Efficacy of Ranolazine in Chronic Angina ( ERICA ) trial .
-METHODS	Angina frequency was classified using the Seattle Angina Questionnaire angina frequency ( SAQAF ) domain into no ( 100 ) ; monthly ( 61-99 ) ; weekly ( 31-60 ) ; and daily ( 0-30 ) angina .
-METHODS	EuroQol ( EQ ) -5 D health utility scores were derived from SAQ data using two mapping equations .
-METHODS	Median EQ-5D utility scores for each SAQAF classification after the 6-week trial period were calculated ( reported as : Equation 1/Equation 2 ) .
-METHODS	Changes in EQ-5D utility scores from baseline to end-of-trial for patients achieving and not achieving a 20-point improvement in SAQAF score and improving and not improving 1 SAQAF classification were compared .
-RESULTS	Median EQ-5D utility scores ( n = 548 ) were 0.68 / 0.60 .
-RESULTS	Compared to patients reporting no angina symptoms ( n = 28 ; 0.89 / 0.87 ) patients reporting monthly ( n = 188 ; 0.80 / 0.76 ) , weekly ( n = 283 ; 0.72 / 0.65 ) and daily ( n = 49 ; 0.65 / 0.54 ) symptoms had poorer health utility ( p < 0.001 for both equations ) .
-RESULTS	Patients improving 1SAQAF classification ( n = 254/541 , 47 % ) experienced a median 0.05 / 0.07 greater improvement in EQ-5D health utility compared to those not improving 1 classification ( p < 0.001 for both equations ) .
-RESULTS	Patients improving 20-points on the SAQAF ( n = 355/541 , 66 % ) experienced a median 0.06 / 0.07 greater improvement in health utility compared to those not achieving a 20-point improvement ( p < 0.001 for both ) .
-CONCLUSIONS	Chronic angina patient health utility decreases as angina frequency increases .
-CONCLUSIONS	Patients reporting clinically important improvement in angina frequency experience a tangible improvement in health utility .
-BACKGROUND	NCT00091429 .
-
-###25420431
-BACKGROUND	Patients with bipolar disorder often show decreased adherence with mood stabilizers and frequently interventions on prodromal depressive and manic symptoms are delayed .
-BACKGROUND	Recently , the MONARCA I randomized controlled trial investigated the effect of electronic self-monitoring using smartphones on depressive and manic symptoms .
-BACKGROUND	The findings suggested that patients using the MONARCA system had more sustained depressive symptoms than patients using a smartphone for normal communicative purposes , but had fewer manic symptoms during the trial .
-BACKGROUND	It is likely that the ability of these self-monitored measures to detect prodromal symptoms of depression and mania may be insufficient compared to automatically generated objective data on measures of illness activity such as phone usage , social activity , physical activity , and mobility .
-BACKGROUND	The Monsenso system , for smartphones integrating subjective and objective measures of illness activity was developed and will be tested in the present trial .
-METHODS	The MONARCA II trial uses a randomized controlled single-blind parallel-group design .
-METHODS	Patients with bipolar disorder according to ICD-10 who previously have been treated at the Copenhagen Clinic for Affective Disorder , Denmark are included and randomized to either daily use of the Monsenso system including an feedback loop between patients and clinicians ( the intervention group ) or to the use of a smartphone for normal communicative purposes ( the control group ) for a 9-month trial period .
-METHODS	The trial was started in September 2014 and recruitment is ongoing .
-METHODS	The outcomes are : differences in depressive and manic symptoms ; rate of depressive and manic episodes ( primary ) ; automatically generated objective data on measures of illness activity ; number of days hospitalized ; psychosocial functioning ( secondary ) ; perceived stress ; quality of life ; self-rated depressive symptoms ; self-rated manic symptoms ; recovery ; empowerment and adherence to medication ( tertiary ) between the intervention group and the control group during the trial .
-METHODS	Ethical permission has been obtained .
-METHODS	Positive , neutral and negative findings will be published .
-CONCLUSIONS	If the system is effective in reducing depressive and/or manic symptoms ( and other symptoms of bipolar disorder ) and the rate of episodes , there will be basis for extending the use to the treatment of bipolar disorder in general and in larger scale .
-BACKGROUND	ClinicalTrials.gov NCT02221336 .
-BACKGROUND	Registered 26th of September 2014 .
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-###24996379
-OBJECTIVE	There are scarce data regarding the impact of sphincterotome design on cannulation success .
-OBJECTIVE	We aimed to compare two different 5.5 Fr standard sphincterotomes to determine initial cannulation success .
-METHODS	Adult patients with naive papillae were enrolled in a prospective , randomized , crossover study .
-METHODS	Two different 5.5 Fr sphincterotomes preloaded with guidewire ( GW ) were used in two groups with 140 patients included per group .
-METHODS	A total of five papillary attempts and two pancreatic channel entries were allowed as maximum targets .
-METHODS	In a case of more than two pancreatic entries , a double GW technique was attempted before crossover .
-METHODS	If choledochal cannulation was not achieved within ten papillary attempts or more than four pancreatic entries despite crossover , access papillotomy was performed .
-METHODS	Successful biliary cannulation was the primary outcome .
-METHODS	Secondary outcomes were incidence of early complications and overall cannulation success .
-RESULTS	Higher initial cannulation success was achieved in group I compared with group II ( 88.5 vs. 77.1 % , p = 0.011 ) .
-RESULTS	The crossover and double GW techniques reduced the need for precut from 11.7 to 5.3 % .
-RESULTS	The overall cannulation success including precut for failed cases was 99.2 % ( group I ) and 98.5 % ( group II ) .
-RESULTS	Sphincterotome type , presence of crossover , and number of cannulation attempts were predictors of successful cannulation in multivariate analysis .
-CONCLUSIONS	There was a significant difference in cannulation success between two different 5.5 Fr sphincterotomes .
-CONCLUSIONS	The cannulation success was mainly governed by sphincterotome design which serves a proper spatial orientation during the procedure .
-CONCLUSIONS	The combined use of crossover and double GW techniques may substantially decrease precut necessity .
-
-###24239213
-BACKGROUND	Providing written medicine information to consumers enables them to make informed decisions about their medicines , playing an important role in educating and improving health literacy .
-BACKGROUND	In Australia , standardized written medicine information called Consumer Medicine Information ( CMI ) is available for medicines as package inserts , computer prints , or leaflets .
-BACKGROUND	Consumers want and read CMI , but may not always ask for it .
-BACKGROUND	General practitioners ( GPs ) and pharmacists are an important source of written medicine information , yet may not always provide CMI in their practice .
-OBJECTIVE	To examine and compare the awareness , use and provision of CMI by consumers , pharmacists and general practitioners ( GPs ) .
-METHODS	Based on previous studies , structured questionnaires were developed and administered to a national sample of consumers ( phone survey ) ; community pharmacists and GPs ( postal surveys ) about utilization of CMI .
-METHODS	Descriptive , comparative and logistic regression analyses were conducted .
-RESULTS	The respondents comprised of 349 pharmacists , 181 GPs and 1000 consumers .
-RESULTS	Two-thirds of consumers , nearly all ( 99 % ) pharmacists and 90 % of GPs were aware of CMI .
-RESULTS	About 88 % of consumers reported receiving CMI as a package insert , however most pharmacists ( 99 % ) and GPs ( 56 % ) reported providing computer-generated CMI .
-RESULTS	GPs ' and pharmacists ' main reason for providing CMI was on patient request .
-RESULTS	Reasons for not providing were predominantly because consumers were already taking the medicine , concerns regarding difficulty understanding the information , or potential non-adherence .
-RESULTS	Of the 691 consumers reportedly reading CMI , 35 % indicated concerns after reading .
-RESULTS	Factors associated with reading included gender , type of CMI received and frequency of provision .
-CONCLUSIONS	Consumers want and read information about their medicines , especially when received from their GP or pharmacist .
-CONCLUSIONS	Healthcare professionals report usually discussing CMI when providing it to patients , although continued improvements in dissemination rates are desirable .
-CONCLUSIONS	Regular use of CMI remains a challenge , and ongoing strategies to promote CMI use are necessary to improve uptake of CMI in Australia .
-
-###24872002
-OBJECTIVE	The aim of this study was to compare the contrast-to-noise ratio ( CNR ) values of infarct and remote myocardium as well as infarct and blood after application of 0.1 mmol/kg gadobutrol and 0.1 mmol/kg gadobenate dimeglumine on late gadolinium enhancement magnetic resonance ( MR ) images .
-METHODS	The study was a prospective randomized controlled clinical study .
-METHODS	After informed consent was obtained , 20 patients ( 12 men , 8 women ; mean age , 67 11 years ) with known chronic myocardial infarction were included for an intraindividual comparison of a single-dose gadobutrol and a single-dose gadobenate dimeglumine .
-METHODS	Two MR imaging examinations were performed within a period of 28 days in a crossover design .
-METHODS	Late gadolinium enhancement imaging was performed 10 minutes after gadolinium administration using a 2-dimensional phase-sensitive inversion recovery gradient echo sequence at 3 T. Infarct size , signal intensities ( SIs ) , signal-to-noise ratio , and CNR were determined on phase-sensitive MR images .
-METHODS	Values for CNR were calculated as CNRinfarct/myocardium = ( SIinfarct - SImyocardium ) / SDnoise and CNRinfarct/blood = ( SIinfarct - SIblood ) / SDnoise .
-METHODS	In addition , the areas of myocardial infarction were determined on single slices .
-METHODS	The entire infarct volumes were calculated by adding the areas with hyperenhancement multiplied by the slice thickness .
-RESULTS	Late gadolinium enhancement was present in all patients .
-RESULTS	Median values of the infarct area , infarct volume , and transmurality for gadobutrol and gadobenate dimeglumine showed good to excellent concordance ( rc = 0.85 , rc = 0.95 , and rc = 0.71 , respectively ) .
-RESULTS	The mean signal-to-noise ratio values for infarct , remote myocardium , and ventricular blood were 18.6 6.5 , 4.1 3.7 , and 14.6 7.5 , respectively , for gadobutrol and 18.8 8.9 , 4.9 4.5 , and 17.8 10.1 , respectively , for gadobenate dimeglumine ( P = 0.93 , P = 0.48 , and P = 0.149 , respectively ) .
-RESULTS	The mean values of CNRinfarct/myocardium and CNRinfarct/blood were 14.5 5.9 and 4.0 4.6 , respectively , for gadobutrol and 13.9 6.1 and 0.9 4.5 , respectively , for gadobenate dimeglumine ( P = 0.69 and P = 0.02 , respectively ) .
-CONCLUSIONS	Both gadobutrol and gadobenate dimeglumine allow for successful late gadolinium enhancement imaging of chronic myocardial infarction after a single-dose application ( 0.1 mmol/kg ) at 3 T. Gadobutrol provides a higher CNR between infarct and blood .
-CONCLUSIONS	The CNRs between infarct and normal myocardium , infarct size , and transmural extent were similar for both contrast agents .
-
-###24956453
-OBJECTIVE	Patients undergoing breast cancer surgery frequently experience chronic postoperative pain .
-OBJECTIVE	The primary objective of this randomized study was to determine if thoracic paravertebral block ( TPVB ) reduced the incidence of chronic pain after a modified radical mastectomy ( MRM ) when compared with general anesthesia ( GA ) .
-METHODS	One hundred eighty women undergoing MRM were randomized to 1 of 3 study groups : group 1 : standardized GA , group 2 : GA with a single-injection TPVB and placebo paravertebral infusion , and group 3 : GA with a continuous TPVB .
-METHODS	Outcomes assessed postoperatively included acute postoperative pain and analgesic consumption and , at 3 and 6 months , the incidence and severity of chronic pain and physical and mental health-related quality of life ( HRQOL ) .
-RESULTS	There was no significant difference in the incidence of chronic pain at 3 months ( P = 0.13 ) and 6 months ( P = 0.79 ) after the MRM between the study groups .
-RESULTS	The relative risk of developing chronic pain ( P = 0.25 ) was also similar between the groups .
-RESULTS	There was no difference in acute pain ( P = 0.22 ) or postoperative analgesic consumption ( P = 0.67 ) between the groups .
-RESULTS	Nevertheless , differences were observed in chronic pain-related secondary outcome variables .
-RESULTS	The TPVB groups reported lower chronic pain scores ( P < 0.05 ) , exhibited fewer symptoms and signs of chronic pain ( P 0.01 ) , and also experienced better physical and mental HRQOL than did the GA group .
-RESULTS	Chronic pain scores also decreased with time in all study groups ( P < 0.05 ) .
-CONCLUSIONS	There is no significant difference in the incidence or relative risk of chronic pain at 3 and 6 months after an MRM when TPVB is used in conjunction with GA. .
-CONCLUSIONS	Nevertheless , patients who receive a TPVB report less severe chronic pain , exhibit fewer symptoms and signs of chronic pain , and also experience better physical and mental HRQOL .
-
-###25927297
-BACKGROUND	Narrative exposure therapy ( NET ) is a brief , manualised treatment for Posttraumatic Stress Disorder ( PTSD ) .
-BACKGROUND	It has been shown to have therapeutic benefits for a wide range of individuals and settings .
-BACKGROUND	This study , following our previous work applying the original NET in earthquake survivors , aimed to revise NET to be adaptable for treating PTSD after a natural disaster .
-METHODS	A randomised waiting-list controlled study was conducted with 30 adult participants with PTSD who were randomly allocated to NET ( n = 10 ) , revised NET ( NET-R ; n = 10 ) or a waiting list condition ( WL ; n = 10 ) .
-METHODS	Participants in NET and NET-R received treatment immediately ; those in the WL condition received NET-R treatment after a waiting period .
-METHODS	All groups were assessed on PTSD , general distress , anxiety , depression , social support , coping and posttraumatic change before and after treatment and three-month follow-up .
-RESULTS	Compared with WL , both NET and NET-R groups showed significant reductions in PTSD and related symptoms .
-RESULTS	Significant increases were found in posttraumatic growth , active coping and perceived social support .
-RESULTS	The WL group showed similar improvements after treatment .
-RESULTS	Further reductions on PTSD symptoms were found at three months , showing that NET-R is as effective as the original NET in treating post-earthquake traumatic symptoms in adult Chinese earthquake survivors .
-CONCLUSIONS	NET-R is a feasible and cost-effective intervention for Chinese earthquake survivors .
-CONCLUSIONS	Further studies are needed to replicate these findings in other survivor populations , and with larger samples and over longer periods .
-CONCLUSIONS	This study highlighted the value of oral narrative approach , which is well-accepted and useful in the context of single natural disaster and lower - income area .
-BACKGROUND	Chinese Clinical Trial Registry : ChiCTR-TRC-12002931 .
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-###24473367
-OBJECTIVE	The objective of the study was to test the diagnostic performance of low-dose computed tomography pulmonary angiography ( CTPA ) at peak tube voltage of 80 kVp with both reduced radiation and reduced contrast material ( CM ) dose .
-METHODS	In this single-center , single-blinded prospective randomized trial , 501 patients with body weights of less than 100 kg with suspected acute pulmonary embolism ( PE ) were assigned to normal-dose CTPA ( 100-kVp tube energy and 100-mL CM , 255 patients ) and low-dose CTPA ( 80-kVp tube energy and 75-mL CM , 246 patients ) .
-METHODS	Primary end points were evidence of PE in CTPA and accuracy of CTPA on a composite reference standard .
-METHODS	Results were compared by calculating the odds ratio with the 95 % confidence interval .
-RESULTS	The reference diagnosis was equivocal in 20 of the 501 patients .
-RESULTS	Diagnosis of CTPA was correct in 240 patients and incorrect in 5 in the normal-dose group .
-RESULTS	Computed tomography pulmonary angiography was correct in 230 patients and incorrect in 6 in the low-dose group ( odds ratio , 1.25 ; 95 % confidence interval , 0.38-4 .16 ; P = 0.77 ) .
-RESULTS	Sensitivity was 96.9 % and 100 % and specificity was 98.1 % and 97.1 % in the normal-dose and low-dose groups , respectively .
-RESULTS	No PE or PE-related death occurred during the 90-day follow-up .
-RESULTS	The size-specific dose estimates were 30 % lower at 80 kVp ( 4.8 1.0 mGy ) compared with that at 100 kVp ( 6.8 1.2 mGy ; P < 0.001 ) .
-CONCLUSIONS	The accuracy of low-dose CTPA at 80 kVp with a 30 % reduced radiation dose and a 25 % lower CM volume is not significantly different from that of normal-dose CTPA at 100 kVp in detecting acute PE in patients weighing less than 100 kg .
-
-###26143666
-OBJECTIVE	To evaluate the association of subretinal hyperreflective material ( SHRM ) with visual acuity ( VA ) , geographic atrophy ( GA ) , and scar in the Comparison of Age-Related Macular Degeneration Treatments Trials ( CATT ) .
-METHODS	Prospective cohort study within a randomized clinical trial .
-METHODS	The 1185 CATT participants .
-METHODS	Masked readers graded scar and GA on fundus photography and fluorescein angiography and graded SHRM on time-domain and spectral-domain ( SD ) optical coherence tomography ( OCT ) throughout 104 weeks .
-METHODS	Measurements of SHRM height and width in the fovea , within the center 1 mm ( 2 ) , or outside the center 1mm ( 2 ) were obtained on SD OCT images at 56 ( n = 76 ) and 104 ( n = 66 ) weeks .
-METHODS	Presence of SHRM , as well as location and size , and associations with VA , scar , and GA. .
-RESULTS	Among CATT participants , the percentage with SHRM at enrollment was 77 % , decreasing to 68 % at 4 weeks after treatment and to 54 % at 104 weeks .
-RESULTS	At 104 weeks , scar was present more often in eyes with persistent SHRM than in eyes with SHRM that resolved ( 64 % vs. 31 % ; P < 0.0001 ) .
-RESULTS	Among eyes with detailed evaluation of SHRM at weeks 56 ( n = 76 ) and 104 ( n = 66 ) , mean VA letter score was 73.5 ( standard error [ SE ] , 2.8 ) , 73.1 ( SE , 3.4 ) , 65.3 ( SE , 3.5 ) , and 63.9 ( SE , 3.7 ) when SHRM was absent , present outside the central 1 mm ( 2 ) , present within the central 1 mm ( 2 ) but not the foveal center , or present at the foveal center ( P = 0.02 ) , respectively .
-RESULTS	When SHRM was present , the median maximum height under the fovea , within the central 1 mm ( 2 ) including the fovea and anywhere within the scan , was 86 m , 120 m , and 122 m , respectively .
-RESULTS	Visual acuity was decreased with greater SHRM height and width ( P < 0.05 ) .
-CONCLUSIONS	In eyes with neovascular age-related macular degeneration ( AMD ) , SHRM is common and often persists after anti-vascular endothelial growth factor treatment .
-CONCLUSIONS	At 2 years , eyes with scar were more likely to have SHRM than other eyes .
-CONCLUSIONS	Greater SHRM dimensions were associated with worse VA. .
-CONCLUSIONS	In eyes with neovascular AMD , SHRM is an important morphologic biomarker .
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-###25307295
-BACKGROUND	A phase 3 randomized clinical trial was designed to test whether bardoxolone methyl , a nuclear factor erythroid-2-related factor 2 ( Nrf2 ) activator , slows progression to end-stage renal disease in patients with stage 4 chronic kidney disease and type 2 diabetes mellitus .
-BACKGROUND	The trial was terminated because of an increase in heart failure in the bardoxolone methyl group ; many of the events were clinically associated with fluid retention .
-RESULTS	We randomized 2,185 patients with type 2 diabetes mellitus ( T2DM ) and stage 4 chronic kidney disease ( CKD ) ( estimated glomerular filtration rate 15 to < 30 mL min ( -1 ) 1.73 m ( -2 ) ) to once-daily bardoxolone methyl ( 20 mg ) or placebo .
-RESULTS	We used classification and regression tree analysis to identify baseline factors predictive of heart failure or fluid overload events .
-RESULTS	Elevated baseline B-type natriuretic peptide and previous hospitalization for heart failure were identified as predictors of heart failure events ; bardoxolone methyl increased the risk of heart failure by 60 % in patients with these risk factors .
-RESULTS	For patients without these baseline characteristics , the risk for heart failure events among bardoxolone methyl - and placebo-treated patients was similar ( 2 % ) .
-RESULTS	The same risk factors were also identified as predictors of fluid overload and appeared to be related to other serious adverse events .
-CONCLUSIONS	Bardoxolone methyl contributed to events related to heart failure and/or fluid overload in a subpopulation of susceptible patients with an increased risk for heart failure at baseline .
-CONCLUSIONS	Careful selection of participants and vigilant monitoring of the study drug will be required in any future trials of bardoxolone methyl to mitigate the risk of heart failure and other serious adverse events .
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-###24247300
-OBJECTIVE	Small studies suggest that low-dose dopamine or low-dose nesiritide may enhance decongestion and preserve renal function in patients with acute heart failure and renal dysfunction ; however , neither strategy has been rigorously tested .
-OBJECTIVE	To test the 2 independent hypotheses that , compared with placebo , addition of low-dose dopamine ( 2 g/kg/min ) or low-dose nesiritide ( 0.005 g/kg/min without bolus ) to diuretic therapy will enhance decongestion and preserve renal function in patients with acute heart failure and renal dysfunction .
-METHODS	Multicenter , double-blind , placebo-controlled clinical trial ( Renal Optimization Strategies Evaluation [ ROSE ] ) of 360 hospitalized patients with acute heart failure and renal dysfunction ( estimated glomerular filtration rate of 15-60 mL/min/1 .73 m2 ) , randomized within 24 hours of admission .
-METHODS	Enrollment occurred from September 2010 to March 2013 across 26 sites in North America .
-METHODS	Participants were randomized in an open , 1:1 allocation ratio to the dopamine or nesiritide strategy .
-METHODS	Within each strategy , participants were randomized in a double-blind , 2:1 ratio to active treatment or placebo .
-METHODS	The dopamine ( n = 122 ) and nesiritide ( n = 119 ) groups were independently compared with the pooled placebo group ( n = 119 ) .
-METHODS	Coprimary end points included 72-hour cumulative urine volume ( decongestion end point ) and the change in serum cystatin C from enrollment to 72 hours ( renal function end point ) .
-RESULTS	Compared with placebo , low-dose dopamine had no significant effect on 72-hour cumulative urine volume ( dopamine , 8524 mL ; 95 % CI , 7917-9131 vs placebo , 8296 mL ; 95 % CI , 7762-8830 ; difference , 229 mL ; 95 % CI , -714 to 1171 mL ; P = .59 ) or on the change in cystatin C level ( dopamine , 0.12 mg/L ; 95 % CI , 0.06-0 .18 vs placebo , 0.11 mg/L ; 95 % CI , 0.06-0 .16 ; difference , 0.01 ; 95 % CI , -0.08 to 0.10 ; P = .72 ) .
-RESULTS	Similarly , low-dose nesiritide had no significant effect on 72-hour cumulative urine volume ( nesiritide , 8574 mL ; 95 % CI , 8014-9134 vs placebo , 8296 mL ; 95 % CI , 7762-8830 ; difference , 279 mL ; 95 % CI , -618 to 1176 mL ; P = .49 ) or on the change in cystatin C level ( nesiritide , 0.07 mg/L ; 95 % CI , 0.01-0 .13 vs placebo , 0.11 mg/L ; 95 % CI , 0.06-0 .16 ; difference , -0.04 ; 95 % CI , -0.13 to 0.05 ; P = .36 ) .
-RESULTS	Compared with placebo , there was no effect of low-dose dopamine or nesiritide on secondary end points reflective of decongestion , renal function , or clinical outcomes .
-CONCLUSIONS	In participants with acute heart failure and renal dysfunction , neither low-dose dopamine nor low-dose nesiritide enhanced decongestion or improved renal function when added to diuretic therapy .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01132846 .
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-###25130678
-BACKGROUND	The administration of statins seems to be a promising new avenue in the treatment of patients suffering from major depressive disorder ( MDD ) , though patients suffering from severe MDD remain unstudied in this respect .
-BACKGROUND	The aim of the present study was therefore to investigate , in a randomized double-blind clinical trial , the influence of adjuvant atorvastatin on symptoms of depression in patients with MDD .
-METHODS	A total of 60 patients suffering from MDD ( mean age : 32.25 years ; 53 % males ) received a standard medication of 40 mg/d citalopram .
-METHODS	Next , patients were randomly assigned either to the atorvastatin group ( 20 mg/d ) or to the placebo group .
-METHODS	Blood lipid values were assessed at baseline and on completion of the study 12 weeks later .
-METHODS	Experts rated depressive symptoms via Hamilton Depression Rating Scales ( HDRS ) at baseline and 3 , 6 and 12 weeks later .
-RESULTS	HDRS scores decreased over time ; the significant Time by Group interaction showed that symptoms of depression decreased more in the atorvastatin than in the placebo group .
-RESULTS	Compared to the placebo group , in the atorvastatin group cholesterol , triglyceride , and Low Density Lipids ( LDL ) significantly decreased , and High Density Lipids ( HDL ) significantly increased over time .
-RESULTS	HDRS scores and blood lipid values were generally not associated .
-CONCLUSIONS	The pattern of results suggests that adjuvant atorvastatin favorably influences symptoms of depression among patients with severe MDD .
-CONCLUSIONS	Given that after 12 weeks of monotherapy and adjuvant atorvastatin patients were still moderately to severely depressed , more powerful treatment algorithms such as augmentation and change of medication are highly recommended .
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-###24721460
-OBJECTIVE	To compare measurement properties of the P4 pain scale , Western Ontario and McMaster Universities Arthritis Index pain subscale ( WOMAC-pain ) , and Intermittent and Constant Osteoarthritis Pain ( ICOAP ) measure in patients with knee osteoarthritis ( OA ) .
-METHODS	A secondary analysis from a randomized controlled trial included participants ( n = 156 ) with knee OA that were consulting with a surgeon regarding knee arthroplasty .
-METHODS	They completed pain measures ( P4 , WOMAC-pain , ICOAP ) and WOMAC-function subscale ( WOMAC-function ) at baseline and 2 weeks .
-METHODS	Measurement properties assessed in various subgroups included floor/ceiling effects , test-retest reliability using intraclass correlation coefficients ( ICC2 ,1 ) , internal consistency using Cronbach 's , factorial structure of each pain measure combined with WOMAC-function using principal component analysis , and responsiveness using standardized response mean ( SRM ) .
-RESULTS	P4 had low floor and ceiling effects ( < 1 % ) .
-RESULTS	P4 test-retest reliability ( ICC2 ,1 = 0.72 ) , internal consistency ( Chronbach 's = 0.91 ) , and responsiveness ( SRM = 0.56 ) were similar to the values for WOMAC-pain and ICOAP .
-RESULTS	Factorial structure of P4 and ICOAP were separate from WOMAC-function items .
-RESULTS	WOMAC-pain and WOMAC-function items loaded on similar factors .
-RESULTS	ICOAP-constant subscale had a large floor effect ( 33 % ) .
-CONCLUSIONS	P4 should be used to measure pain in patients with knee OA .
-CONCLUSIONS	It had acceptable measurement properties which is comparable to more widely used pain measures .
-CONCLUSIONS	WOMAC-pain shared a factorial structure with WOMAC-function indicating these measures might be capturing the same construct , questioning its validity to measure pain separately from function .
-CONCLUSIONS	ICOAP had acceptable properties .
-CONCLUSIONS	More work should compare pain measures in less severely affected OA populations .
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-###25907157
-BACKGROUND	Individuals with a history of recurrent depression have a high risk of repeated depressive relapse or recurrence .
-BACKGROUND	Maintenance antidepressants for at least 2 years is the current recommended treatment , but many individuals are interested in alternatives to medication .
-BACKGROUND	Mindfulness-based cognitive therapy ( MBCT ) has been shown to reduce risk of relapse or recurrence compared with usual care , but has not yet been compared with maintenance antidepressant treatment in a definitive trial .
-BACKGROUND	We aimed to see whether MBCT with support to taper or discontinue antidepressant treatment ( MBCT-TS ) was superior to maintenance antidepressants for prevention of depressive relapse or recurrence over 24 months .
-METHODS	In this single-blind , parallel , group randomised controlled trial ( PREVENT ) , we recruited adult patients with three or more previous major depressive episodes and on a therapeutic dose of maintenance antidepressants , from primary care general practices in urban and rural settings in the UK .
-METHODS	Participants were randomly assigned to either MBCT-TS or maintenance antidepressants ( in a 1:1 ratio ) with a computer-generated random number sequence with stratification by centre and symptomatic status .
-METHODS	Participants were aware of treatment allocation and research assessors were masked to treatment allocation .
-METHODS	The primary outcome was time to relapse or recurrence of depression , with patients followed up at five separate intervals during the 24-month study period .
-METHODS	The primary analysis was based on the principle of intention to treat .
-METHODS	The trial is registered with Current Controlled Trials , ISRCTN26666654 .
-RESULTS	Between March 23 , 2010 , and Oct 21 , 2011 , we assessed 2188 participants for eligibility and recruited 424 patients from 95 general practices .
-RESULTS	212 patients were randomly assigned to MBCT-TS and 212 to maintenance antidepressants .
-RESULTS	The time to relapse or recurrence of depression did not differ between MBCT-TS and maintenance antidepressants over 24 months ( hazard ratio 089 , 95 % CI 067-118 ; p = 043 ) , nor did the number of serious adverse events .
-RESULTS	Five adverse events were reported , including two deaths , in each of the MBCT-TS and maintenance antidepressants groups .
-RESULTS	No adverse events were attributable to the interventions or the trial .
-CONCLUSIONS	We found no evidence that MBCT-TS is superior to maintenance antidepressant treatment for the prevention of depressive relapse in individuals at risk for depressive relapse or recurrence .
-CONCLUSIONS	Both treatments were associated with enduring positive outcomes in terms of relapse or recurrence , residual depressive symptoms , and quality of life .
-BACKGROUND	National Institute for Health Research ( NIHR ) Health Technology Assessment ( HTA ) programme , and NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula .
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-###24862764
-OBJECTIVE	To compare the effects of exergaming with conventional weight-shift training on balance function in patients with chronic stroke .
-METHODS	Single-blind randomized controlled trial .
-METHODS	Medical center .
-METHODS	Patients ( N = 30 ) with chronic stroke and balance deficits .
-METHODS	Twelve weeks of Wii Fit training or conventional weight-shift training .
-METHODS	Static balance was assessed using posturography .
-METHODS	We recorded the stability index and percentage of weight bearing on the affected leg in 8 positions .
-METHODS	We also used the timed Up and Go and forward reach tests for dynamic balance evaluation , Falls Efficacy Scale-International for fear of falling assessment , and Physical Activity Enjoyment Scale for estimating the enjoyment of training .
-RESULTS	The exergaming group showed more improvement in stability index than the control group in head straight with eyes open while standing on a foam surface , eyes closed while standing on a solid surface with head turned 30 to the left , and eyes closed while standing on a solid surface with head turned up positions ( time-group interaction P = .02 , .04 , and .03 , respectively ) ; however , the effects were not maintained .
-RESULTS	At 3-month follow-up , the control group showed more improvement in weight-bearing symmetry in the head straight with eyes open while standing on a solid surface position than the exergaming group ( time-group interaction P = .03 ) .
-RESULTS	Both groups showed improvement in the timed Up and Go test , forward reach test , and fear of falling .
-RESULTS	The improvement in fear of falling was not maintained .
-RESULTS	The exergaming group enjoyed training more than the control group ( P = .03 ) .
-CONCLUSIONS	Exergaming is enjoyable and effective for patients with chronic stroke .
-
-###25474232
-OBJECTIVE	The aim of this study was to compare the recurrence rates for primary pterygia after fibrin glue-assisted conjunctival autograft ( CAG ) versus conjunctivolimbal autograft ( CLAG ) transplantation , using a technique of limited conjunctival resection and Tenon extended removal .
-METHODS	In this comparative case series , 49 eyes of 47 patients with primary nasal pterygium were included .
-METHODS	Patients were randomized into 2 groups to undergo fibrin glue-assisted CAG ( group 1 , 24 eyes ) or fibrin glue-assisted CLAG ( group 2 , 25 eyes ) following excision of pterygium .
-METHODS	The surgical technique used in all patients involved limited conjunctival resection combined with extensive removal of the Tenon capsule up to the caruncle medially and also 5 mm beyond the inferior and superior free edges of the conjunctiva .
-METHODS	The main outcome measure studied was the absence or presence of recurrence .
-RESULTS	There was 0 % recurrence rate in both groups after a mean follow-up of 63 weeks ( range , 54-81 weeks ) with all eyes completing at least 1-year of follow-up .
-CONCLUSIONS	Fibrin glue-assisted CAG and CLAG using the technique of conjunctival resection and Tenon extended removal were equally efficacious in terms of preventing recurrences in patients with primary pterygia in our series .
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-###24421886
-BACKGROUND	Acellular pertussis vaccines do not control pertussis .
-BACKGROUND	A new approach to offer protection to infants is necessary .
-BACKGROUND	BPZE1 , a genetically modified Bordetella pertussis strain , was developed as a live attenuated nasal pertussis vaccine by genetically eliminating or detoxifying 3 toxins .
-METHODS	We performed a double-blind , placebo-controlled , dose-escalating study of BPZE1 given intranasally for the first time to human volunteers , the first trial of a live attenuated bacterial vaccine specifically designed for the respiratory tract .
-METHODS	12 subjects per dose group received 10 , 10 or 10 colony-forming units as droplets with half of the dose in each nostril .
-METHODS	12 controls received the diluent .
-METHODS	Local and systemic safety and immune responses were assessed during 6 months , and nasopharyngeal colonization with BPZE1 was determined with repeated cultures during the first 4 weeks after vaccination .
-RESULTS	Colonization was seen in one subject in the low dose , one in the medium dose and five in the high dose group .
-RESULTS	Significant increases in immune responses against pertussis antigens were seen in all colonized subjects .
-RESULTS	There was one serious adverse event not related to the vaccine .
-RESULTS	Other adverse events were trivial and occurred with similar frequency in the placebo and vaccine groups .
-CONCLUSIONS	BPZE1 is safe in healthy adults and able to transiently colonize the nasopharynx .
-CONCLUSIONS	It induces immune responses in all colonized individuals .
-CONCLUSIONS	BPZE1 can thus undergo further clinical development , including dose optimization and trials in younger age groups .
-BACKGROUND	ClinicalTrials.gov NCT01188512 .
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-###25041312
-OBJECTIVE	This study aimed to evaluate the internal consistency reliability and construct validity of the Fitzpatrick Skin Type Scale during radiation therapy in a cohort of women receiving treatment for breast cancer .
-METHODS	The assessment of the scale was performed as a nested study within a randomised controlled trial of two creams used for radiation therapy skin care for breast cancer patients .
-METHODS	The sample consisted of 244 female patients undergoing radiation therapy for breast cancer .
-METHODS	Participants completed a modified version of the Fitzpatrick Skin Type Scale .
-RESULTS	Internal consistency as measured by Cronbach 's alpha was 0.505 , 0.829 and 0.339 for the Genetic Disposition , Sun Exposure and Tanning Habits subscales respectively .
-RESULTS	Only the Sun Exposure subscale surpassed the 0.70 cut-off , indicating good internal consistency .
-RESULTS	Maximum likelihood factor analysis with promax rotation method confirmed the a priori factor structure for the Sun Exposure subscale as well as providing evidence of construct validity for this subscale .
-RESULTS	Analysis for the other two subscales highlighted issues with internal reliability and construct validity suggesting that not all items on each subscale truly measure the intended trait .
-CONCLUSIONS	The study findings support reliability and validity of the Sun Exposure subscale of the Fitzpatrick Skin Type Scale in a convenience sample of women receiving radiation therapy for cancer .
-CONCLUSIONS	Despite limitations with two of the three subscales , this tool continues to be used in clinical practice .
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-###25611228
-BACKGROUND	Treatment impact on quality of life ( QoL ) informs treatment management decisions in advanced nonsquamous non-small-cell lung cancer ( NS NSCLC ) .
-BACKGROUND	QoL outcomes from the phase III PointBreak trial are reported .
-METHODS	Chemonaive patients ( n = 939 ) with stage IIIB/IV nonsquamous non-small-cell lung cancer and Eastern Cooperative Oncology Group performance status 0 to 1 were randomized ( 1:1 ) to pemetrexed-carboplatin-bevacizumab ( pemetrexed arm ) or paclitaxel-carboplatin-bevacizumab ( paclitaxel arm ) .
-METHODS	Patients without progressive disease received maintenance pemetrexed-bevacizumab ( pemetrexed arm ) or bevacizumab ( paclitaxel arm ) .
-METHODS	QoL was assessed using Functional Assessment of Cancer Therapy ( FACT ) - General ( FACT-G ) , FACT-Lung ( FACT-L ) , and FACT/Gynecologic Oncology Group-Neurotoxicity ( FACT-Ntx ) instruments .
-METHODS	Subscale scores , total scores , and trial outcome indices were analyzed using linear mixed-effects models .
-METHODS	Post hoc analyses examined the association between baseline FACT scores and overall survival ( OS ) .
-RESULTS	Mean score differences in change from baseline significantly favored the pemetrexed arm for the neurotoxicity subscale score , FACT-Ntx total scores , and FACT-Ntx trial outcome index .
-RESULTS	They occurred at cycle 2 ( p < 0.001 ) and persisted through induction cycles 2 to 4 and six maintenance cycles .
-RESULTS	Investigator-assessed , qualitative , drug-related differences in grade 2 ( 1.6 % versus 10.6 % ) and grade 3 ( 0.0 % versus 4.1 % ) sensory neuropathy and grade 3/4 fatigue ( 10.9 % versus 5.0 % , p = 0.0012 ) were observed between the pemetrexed and paclitaxel arms .
-RESULTS	Baseline FACT-G , FACT-L , and FACT-Ntx scores were significant prognostic factors for OS ( p < 0.001 ) .
-CONCLUSIONS	Randomized patients reported similar changes in QoL , except for less change from baseline in neurotoxicity on the pemetrexed arm ; investigators reported greater neurotoxicity on the paclitaxel arm and greater fatigue on the pemetrexed arm .
-CONCLUSIONS	Higher baseline FACT scores were favorable prognostic factors for OS .
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-###24565092
-OBJECTIVE	Initiation of epidural anesthesia with long-lasting local anesthetics consumes a significant amount of time , which could be problematic in busy obstetric anesthesia suites .
-OBJECTIVE	We have hypothesized that a combination of articaine and ropivacaine provides faster onset and even an early recovery of sensory-motor block characteristics .
-METHODS	Sixty term parturients scheduled to have elective cesarean section were randomly allocated into three groups to receive either 20 mL 2 % articaine ( Group A ) , 10 mL 2 % articaine + 10 mL 0.75 % ropivacaine ( Group AR ) or 20 mL 0.75 % ropivacaine ( Group R ) via lumbar epidural catheter .
-METHODS	The onset time of sensory block to T10 , T6 and maximum sensory block level , time to two segments regression from maximum sensory block level , onset time and duration of motor block were all recorded .
-METHODS	Intraoperative and postoperative additional analgesic requirements were also recorded .
-RESULTS	Demographic data were similar .
-RESULTS	The onset times of sensorial block to T10 and T6 were significantly shorter in Groups A and AR in comparison with Group R ( p < 0.05 ) .
-RESULTS	The onset times of motor block were similar in all groups , but a more intense motor block was observed in Group R ( p < 0.05 ) .
-RESULTS	Two segments regression time and motor block durations were significantly shorter in Groups A and AR in comparison with Group R ( p < 0.05 ) .
-RESULTS	Intraoperative supplementary analgesic requirements were higher in Group A than in the other two groups ( p < 0.05 ) .
-CONCLUSIONS	A combination of 2 % articaine and 0.75 % ropivacaine for epidural anesthesia in a cesarean section should be preferred over epidural 0.75 % ropivacaine alone .
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-###24638852
-BACKGROUND	Few clinical studies involving cigarettes have provided a comprehensive picture of smoke exposure , test article characterization , and insights into sensory properties combined .
-BACKGROUND	The purpose of these pilot studies was to determine whether cigarettes with different levels of nicotine but similar tar levels would affect sensory experience or smoking behavior so as to significantly alter levels of selected biomarkers of exposure ( BOE ) .
-METHODS	In 2 confined , double-blind studies , 120 adult smokers switched from Marlboro Gold cigarettes at baseline to either 1 of 2 lower nicotine cigarettes or 1 of 2 higher nicotine cigarettes and then to the other cigarette after 5 days .
-METHODS	Urinary excretion of exposure biomarkers ( nicotine equivalents [ NE ] , total and free 4 - ( methylnitrosamino ) -1 - ( 3-pyridyl ) -1 - butanol [ NNAL ] , 1-hydroxypyrene , and 3-hydroxypropyl mercapturic acid ) as well as carboxyhemoglobin and plasma cotinine were measured at baseline , Day 5 , and Day 10 .
-METHODS	Daily cigarette consumption was monitored and sensory characteristics were rated for each cigarette .
-RESULTS	With higher nicotine yield , urine NE , urine total NNAL , and plasma cotinine increased while nonnicotine BOE decreased without changes in cigarette consumption .
-RESULTS	In contrast , with lower nicotine yield , urine NE , urine total NNAL , and plasma cotinine dropped while nonnicotine BOE and cigarettes per day increased .
-RESULTS	Higher nicotine cigarettes were rated harsher and stronger than at baseline while lower nicotine cigarettes were less strong .
-RESULTS	All 4 test cigarettes were highly disliked .
-CONCLUSIONS	These studies demonstrate that abrupt increases or decreases in nicotine and the resulting sensory changes impact BOE through changes in intensity or frequency of smoking .
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-###25970861
-OBJECTIVE	To compare the measurements and growth rates of geographic atrophy ( GA ) secondary to age-related macular degeneration ( AMD ) obtained using different imaging modalities .
-METHODS	Thirty patients with AMD and GA measuring from 1.25 mm to 18 mm based on spectral-domain optical coherence tomography ( SD-OCT ) fundus imaging were enrolled .
-METHODS	Imaging was performed at baseline and at follow-up months 3 , 6 , 9 , and 12 , including autofluorescence ( AF ) imaging with a fundus camera-based flash system ( TRC-50DX ; Topcon Medical Systems , Oakland , NJ ; AF excitation : 535-585 nm ; detection : 605-715 nm ) , AF and fluorescein angiography ( FA ) imaging with a confocal scanning laser ophthalmoscopy ( SLO ) system ( Spectralis ; Heidelberg Engineering , Heidelberg , Germany ; AF excitation : 488 nm ; detection : > 500 nm ) , and SD-OCT en face imaging ( Cirrus ; Carl Zeiss Meditec , Dublin , CA ) .
-RESULTS	Average baseline square root measurements and enlargement rates of square root areas appeared similar across all modalities ; 0.2 mm was the largest difference between any pair of measurement means .
-RESULTS	The intraclass correlation coefficients ( ICC ) were essentially equal to 1 for all comparisons of area measurements but were lower for growth rates than area measurements .
-RESULTS	Comparison of 26-week average enlargement rates showed no significant difference between the SLO AF image and enhanced SD-OCT en face image ( mean difference : 0.01 mm ; SD : 0.10 ; P = .70 ) .
-CONCLUSIONS	Agreement among all imaging modalities in measuring the areas of GA at baseline diminished when the growth rates of GA were compared over 26 weeks , likely because each imaging technique identifies different anatomic features along the border of GA , which may appear similar but change at different rates .
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-###25130704
-BACKGROUND	Red blood cell ( RBC ) transfusion is frequently used to treat women with acute anaemia after postpartum haemorrhage .
-BACKGROUND	We aimed to assess the economic consequences of red blood cell transfusion compared to non-intervention in these women .
-METHODS	A trial-based cost-effectiveness analysis was performed alongside the Well-Being of Obstetric patients on Minimal Blood transfusions ( WOMB ) trial .
-METHODS	Women with acute anaemia [ Hb 48-79g / dl ( 30-49mm ) ] after postpartum haemorrhage , without severe anaemic symptoms , were randomly allocated to RBC transfusion or non-intervention .
-METHODS	Primary outcome of the trial was physical fatigue ( Multidimensional Fatigue Inventory , scale 4-20 ; 20 represents maximal fatigue ) .
-METHODS	Total costs per arm were calculated using a hospital perspective with a 6weeks time horizon .
-RESULTS	Per woman , mean costs in the RBC transfusion arm ( n = 258 ) were 1957 compared to 1708 in the non-intervention arm ( n = 261 ; P = 0024 ) .
-RESULTS	The 13 % difference in costs between study arms predominantly originated from costs of RBC units , as costs of RBC units were six times higher in the RBC transfusion arm .
-RESULTS	RBC transfusion led to a small improvement in physical fatigue of 058 points per day ; thus , the costs to improve the physical fatigue score with one point would be 431 .
-CONCLUSIONS	In women with acute anaemia after postpartum haemorrhage ( PPH ) , RBC transfusion is on average 249 more expensive per woman than non-intervention , with only a small gain in HRQoL after RBC transfusion .
-CONCLUSIONS	Taking both clinical and economic consequences into account , implementation of a non-intervention policy seems justified .
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-###25077896
-BACKGROUND	Regular endotracheal tube cuff monitoring may prevent silent aspiration .
-OBJECTIVE	We hypothesised that active management of the cuff of the tracheal tube during deep hypothermic cardiac arrest would reduce silent subglottic aspiration .
-OBJECTIVE	We also determined to study its effect on postoperative mechanical ventilation and the incidence of postoperative positive tracheal cultures .
-METHODS	A randomised clinical trial .
-METHODS	The study was conducted in a University Teaching Hospital from September 2008 to November 2009 .
-METHODS	Twenty-four patients undergoing elective pulmonary endarterectomy were included in the study .
-METHODS	After induction of general anaesthesia and tracheal intubation , the cuff of the tracheal tube was inflated to 25cmH2O .
-METHODS	Following this , 1ml of methylene blue dye diluted in 2ml of physiological saline was injected into the hypopharynx .
-METHODS	Patients were randomly assigned to active cuff management during cooling and warming ( where cuff pressure was monitored and the cuff was reinflated if it dropped below 20cmH2O , or deflated if pressure exceeded 30cmH2O ) or passive monitoring ( where cuff pressure was monitored but volume was not altered ) .
-METHODS	Before weaning from cardiopulmonary bypass , fibreoptic bronchoscopy was performed .
-METHODS	Silent aspiration was then diagnosed if blue dye was seen in the trachea below the cuff of the tube .
-METHODS	The primary aim of this study was to determine the incidence of silent aspiration .
-METHODS	Secondary outcomes included duration of postoperative mechanical ventilation of the lungs and incidence of positive culture of tracheal aspirate .
-RESULTS	Active cuff management patients were younger than controls ( 51.211.6 vs. 63.29 years , P = 0.028 ) , but otherwise the two groups were similar .
-RESULTS	The primary endpoint was reached because we showed that silent aspiration was significantly less frequent in the study group ( 0/12 vs. 8/12 patients , P = 0.001 ) .
-RESULTS	Significantly lower intracuff pressures were measured in the control group patients at several timepoints during cooling , just before hypothermic arrest and at all timepoints during rewarming .
-CONCLUSIONS	We recommend that the cuff of the tracheal tube should be checked regularly during surgery under deep hypothermia , and the cuff pressure adjusted as required .
-
-###24742019
-BACKGROUND	Cetuximab is a chimeric monoclonal antibody against the epidermal growth factor receptor ( EGFR ) .
-BACKGROUND	Skin reactions are the most common side effects of cetuximab .
-BACKGROUND	Rhagades of the tips of the fingers and toes , the heels and especially the interphalangeal joints are one of the most frightening and painful dermatological side effects that may develop from EGFR-inhibitor therapy .
-BACKGROUND	Rhagades are characterized by pain , severe tenderness and poor healing response .
-BACKGROUND	They are challenging to treat .
-BACKGROUND	Thus , rhagades often poses the most significant threat to the quality of life ( QoL ) for these patients .
-BACKGROUND	Ethyl-2-cyanoacrylate ( ECA ) , an ethyl ester of the 2-cyano-2-propenoic acid , is often used as adhesive in a variety of different work settings in industry , i.e. as a component in nail-care products such as nail glue .
-BACKGROUND	In addition , ECA is used for various medical indications , such as for liquid bandages and for suture-less surgery .
-BACKGROUND	Wound healing can be accelerated with ECA .
-BACKGROUND	The purpose of the SUPPORT trial is to investigate the efficacy of ECA for the treatment of cetuximab-induced rhagades and to assess the clinical usefulness of the SUPO score , a new classification system for rhagades induced by EGFR-inhibitor therapy .
-METHODS	The SUPPORT trial is an open-label , prospective , randomized , national multicenter intervention study to evaluate the effectiveness of ECA versus the standard treatment of each institution on the pain intensity and QoL in patients with locally advanced head and neck cancer suffering from painful cetuximab-induced rhagades during radioimmunotherapy .
-METHODS	Primary endpoint is the assessment of the pain intensity 24 hours after application of ECA or the standard treatment quantified by the visual analogue scale ( VAS ) .
-METHODS	Secondary endpoints are the evaluation of QoL assessed by the EORTC-QoL-C30 questionnaire and the Dermatological Life Quality Index ( DLQI ) .
-CONCLUSIONS	During treatment with EGFR inhibitors it is necessary to recognize and manage side effects promptly to assure better patient QoL .
-CONCLUSIONS	The SUPPORT trial is the first randomized clinical trial evaluating a new treatment option for painful cetuximab-induced rhagades .
-CONCLUSIONS	Furthermore , the new SUPO score will be prospectively assessed in terms of clinical usefulness for classification of EGFR inhibitor-induced rhagades .
-BACKGROUND	Current Controlled Trials NCT01693159 .
-
-###24655119
-BACKGROUND	The aim of this study was to characterize cardiac reactivity measures , heart rate ( HR ) , and heart rate variability ( HRV ) , following acute intravenous ( IV ) alcohol administration and their association with subjective responses in social drinkers .
-METHODS	Twenty-four subjects ( 11 females ) received IV alcohol infusions to attain and clamp the breath alcohol concentration ( BrAC ) at 50 mg % or placebo in separate sessions .
-METHODS	Serial 5-minute cardiac recordings at baseline and during the infusion were analyzed to obtain frequency and time domain cardiac measures .
-METHODS	Self-reported subjective perceptions were also obtained at the same time points .
-RESULTS	HR showed significant decreases from baseline , while the HRV measure pNN50 showed steady increases during the ascending phase of alcohol infusion .
-RESULTS	HR was inversely correlated with pNN50 across time and treatment .
-RESULTS	There was a significant association of HR with subjective feelings of high , intoxication , feeling drug effects , and liking drug effects across time during the ascending phase .
-CONCLUSIONS	Acute IV alcohol resulted in decreases in HR and increases in HRV consistent with autonomic parasympathetic activation .
-CONCLUSIONS	The association of these changes with subjective responses suggests that cardiac reactivity may serve as a physiological marker of subjective alcohol effects .
-CONCLUSIONS	This study broadens the understanding of acute cardiovascular effects of alcohol and clinically significant cardiac conditions such as arrhythmia and cardiomyopathy associated with chronic alcohol drinking .
-
-###24911577
-OBJECTIVE	A 5-h phase advance model of insomnia was used to evaluate the efficacy of lorediplon , a new non-benzodiazepine hypnotic .
-METHODS	Thirty-five male , healthy subjects were included in a five-way randomized cross-over study .
-METHODS	During each of the periods , sleep was recorded , and residual effects were measured .
-METHODS	All subjects received lorediplon 1 , 5 , and 10 mg , placebo , and zolpidem 10 mg ( i.e. , active control ) .
-RESULTS	Polysomnographic evaluation revealed that lorediplon ( 5 and 10 mg ) significantly decreased wake after sleep onset ( WASO ) and increased total sleep time .
-RESULTS	Analysis by quarters of the night showed a progressive increasing effectiveness of lorediplon 10 mg across the first three quarters .
-RESULTS	Lorediplon increased non-rapid eye movement slow wave sleep and stage N2 sleep in the second and third quarters .
-RESULTS	The magnitude of these effects was dose related , with minimal effects seen with 1 mg .
-RESULTS	No residual effects were observed 13 h post dose .
-CONCLUSIONS	Lorediplon demonstrated a dose-dependent improvement in sleep , whereas zolpidem showed a more sustained WASO effect .
-CONCLUSIONS	No next-day hangover effects were observed .
-CONCLUSIONS	These sleep effects are also consistent with the pharmacokinetic profile of lorediplon .
-CONCLUSIONS	These results warrant clinical trials in patients with insomnia .
-
-###24290290
-BACKGROUND	Whether adiposity indicators other than body mass index ( BMI ) should be used in studies of childhood asthma is largely unknown .
-BACKGROUND	The role of atopy in `` obese asthma '' is also unclear .
-OBJECTIVE	To examine the relationship among adiposity indicators , asthma , and atopy in Puerto Rican children , and to assess whether atopy mediates the obesity-asthma association .
-METHODS	In a study of Puerto Rican children with ( n = 351 ) and without ( n = 327 ) asthma , we measured BMI , percent of body fat , waist circumference , and waist-to-hip ratio .
-METHODS	The outcomes studied included asthma , lung function , measures of atopy , and , among cases , indicators of asthma severity or control .
-METHODS	We performed mediation analysis to assess the contribution of atopy to the relationship between adiposity and asthma .
-RESULTS	BMI , percent of body fat , and waist circumference were associated with increased odds of asthma .
-RESULTS	Among cases , all 3 measures were generally associated with lung function , asthma severity/control , and atopy ; however , there were differences depending on the adiposity indicator analyzed .
-RESULTS	Atopy considerably mediated the adiposity-asthma association in this population : allergic rhinitis accounted for 22 % to 53 % of the association with asthma , and sensitization to cockroach mediated 13 % to 20 % of the association with forced vital capacity and 29 % to 42 % of the association with emergency department visits for asthma .
-CONCLUSIONS	Adiposity indicators are associated with asthma , asthma severity/control , and atopy in Puerto Rican children .
-CONCLUSIONS	Atopy significantly mediates the effect of adiposity on asthma outcomes .
-CONCLUSIONS	Longitudinal studies are needed to further investigate the causal role , if any , of adiposity distribution and atopy on `` obese asthma '' in childhood .
-
-###24702835
-BACKGROUND	Preconception-initiated low-dose aspirin might positively affect pregnancy outcomes , but this possibility has not been adequately assessed .
-BACKGROUND	Our aim was to investigate whether low-dose aspirin improved livebirth rates in women with one to two previous pregnancy losses .
-METHODS	In this multicentre , block-randomised , double-blind , placebo-controlled trial , women aged 18-40 years who were attempting to become pregnant were recruited from four medical centres in the USA .
-METHODS	Participants were stratified by eligibility criteria -- the original stratum was restricted to women with one loss at less than 20 weeks ' gestation during the previous year , whereas the expanded stratum included women with one to two previous losses , with no restrictions on gestational age or time of loss .
-METHODS	Women were block-randomised by centre and eligibility stratum in a 1:1 ratio .
-METHODS	Preconception-initiated daily low-dose aspirin ( 81 mg per day ) plus folic acid was compared with placebo plus folic acid for up to six menstrual cycles ; for women who conceived , study treatment continued until 36 weeks ' gestation .
-METHODS	Participants , trial staff , and investigators were masked to the assigned treatment .
-METHODS	The primary outcome was livebirth rate , which was analysed by intention to treat .
-METHODS	The trial is registered with ClinicalTrials.gov , number NCT00467363 .
-RESULTS	Overall , 1228 women were recruited and randomly assigned between June 15 , 2007 , and July 15 , 2011 , 1078 of whom completed the trial and were included in the analysis ( 535 in the low-dose aspirin group and 543 in the placebo group ) .
-RESULTS	309 ( 58 % ) women in the low-dose aspirin group had livebirths , compared with 286 ( 53 % ) in the placebo group ( p = 00984 ; absolute difference in livebirth rate 509 % [ 95 % CI -084 to 1102 ] ) .
-RESULTS	Pregnancy loss occurred in 68 ( 13 % ) women in the low-dose aspirin group , compared with 65 ( 12 % ) women in the placebo group ( p = 07812 ) .
-RESULTS	In the original stratum , 151 ( 62 % ) of 242 women in the low-dose aspirin group had livebirths , compared with 133 ( 53 % ) of 250 in the placebo group ( p = 00446 ; absolute difference in livebirth rate 920 % [ 051 to 1789 ] ) .
-RESULTS	In the expanded stratum , 158 ( 54 % ) of 293 women in the low-dose aspirin group and 153 ( 52 % ) of 293 in the placebo group had livebirths ( p = 07406 ; absolute difference in livebirth rate 171 % [ -637 to 979 ] ) .
-RESULTS	Major adverse events were similar between treatment groups .
-RESULTS	Low-dose aspirin was associated with increased vaginal bleeding , but this adverse event was not associated with pregnancy loss .
-CONCLUSIONS	Preconception-initiated low-dose aspirin was not significantly associated with livebirth or pregnancy loss in women with one to two previous losses .
-CONCLUSIONS	However , higher livebirth rates were seen in women with a single documented loss at less than 20 weeks ' gestation during the previous year .
-CONCLUSIONS	Low-dose aspirin is not recommended for the prevention of pregnancy loss .
-BACKGROUND	Eunice Kennedy Shriver National Institute of Child Health and Human Development ( US National Institutes of Health ) .
-
-###25735045
-OBJECTIVE	To evaluate intereye corneal asymmetry in Pentacam ( Oculus Optikgerte GmbH , Wetzlar , Germany ) indices as a diagnostic method between normal patients and patients with keratoconus .
-METHODS	A retrospective , observational case series of 177 healthy , 44 indeterminate , and 121 patients with keratoconus classified by Pentacam ectasia detection indices , randomized to analysis and validation datasets .
-METHODS	Intereye asymmetry in 20 Scheimpflug tomography corneal descriptors was calculated and compared to develop diagnostic models .
-RESULTS	Intereye asymmetry was not correlated with anisometropia in healthy controls but was correlated with the ectasia grade of the worse eye in patients with keratoconus .
-RESULTS	Patients with keratoconus had significantly greater intereye asymmetry in all descriptors except for relational thickness indices .
-RESULTS	Intereye asymmetry in front elevation at the thinnest corneal location afforded the single highest diagnostic performance ( 71 % sensitivity and 85 % specificity ) , whereas the best multivariate model combining intereye asymmetry in anterior and posterior keratometry , corneal thickness , and front and back elevation at the thinnest point provided 65 % sensitivity and 97 % specificity .
-RESULTS	Multivariate models upheld their performance in the validation dataset .
-RESULTS	Most ( more than 90 % ) indeterminate patients , according to conventional Pentacam analysis , showed within-normal-range corneal asymmetry .
-CONCLUSIONS	Healthy corneas are markedly symmetric irrespective of anisometropia , but corneal asymmetry analysis does not provide sufficient sensitivity to be used alone for detecting keratoconus .
-CONCLUSIONS	However , its remarkable specificity suggests that it could be used combined with conventional single cornea Pentacam analysis to reduce the false-positive rate or in dubious cases .
-
-###25847555
-OBJECTIVE	To determine effects of Argentine tango on motor and non-motor manifestations of Parkinson 's disease .
-METHODS	Randomized control trial .
-METHODS	Forty patients with idiopathic Parkinson 's disease .
-METHODS	Movement disorder clinic and dance studio .
-METHODS	Two randomized groups : group ( N = 18 ) with 24 partnered tango classes , and control self-directed exercise group ( N = 15 ) .
-METHODS	The primary outcome was overall motor severity .
-METHODS	Secondary outcomes included other motor measures , balance , cognition , fatigue , apathy , depression and quality of life .
-RESULTS	On the primary intention-to-treat analysis there was no difference in motor severity between groups MDS-UPDRS-3 ( 1.6 vs.1.2-point reduction , p = 0.85 ) .
-RESULTS	Patient-rated clinical global impression of change did not differ ( p = 0.33 ) , however examiner rating improved in favor of tango ( p = 0.02 ) .
-RESULTS	Mini-BESTest improved in the tango group compared to controls ( 0.72.2 vs. -2.75.9 , p = 0.032 ) .
-RESULTS	Among individual items , tango improved in both simple TUG time ( -1.31.6 s vs. 0.12.3 , p = 0.042 ) and TUG Dual Task score ( 0.40.9 vs. -0.20.4 , p = 0.012 ) , with borderline improvement in walk with pivot turns ( 0.20.5 vs. -0.10.5 , p = 0.066 ) .
-RESULTS	MoCa ( 0.41.6 vs. -0.61.5 , p = 0.080 ) and FSS ( -3.610.5 vs. 2.56.2 , p = 0.057 ) showed a non-significant trend toward improvement in the tango group .
-RESULTS	Tango participants found the activity more enjoyable ( p < 0.001 ) and felt more `` overall '' treatment satisfaction ( p < 0.001 ) .
-RESULTS	We found no significant differences in other outcomes or adverse events .
-CONCLUSIONS	Argentine tango can improve balance , and functional mobility , and may have modest benefits upon cognition and fatigue in Parkinson 's disease .
-CONCLUSIONS	These findings must be confirmed in longer-term trials explicitly powered for cognition and fatigue .
-
-###25390870
-OBJECTIVE	The aim of this preliminary clinical report was to evaluate and compare the clinical outcomes of immediate and early loaded mini-implants ( MIs ) supporting mandibular overdentures .
-METHODS	Thirty-six completely edentulous patients ( 20 men and 16 women ) complaining of insufficient retention of their mandibular dentures were randomly assigned to two groups .
-METHODS	Each patient received four MIs in the interforaminal area of the mandible using the nonsubmerged flapless surgical approach .
-METHODS	In group 1 ( G1 ) , MIs were loaded with mandibular overdentures using the immediate loading protocol , while in group 2 ( G2 ) , MIs were loaded with overdentures using the early loading protocol .
-METHODS	The cumulative survival rate was calculated using Kaplan-Meier analysis .
-METHODS	Peri-implant health indices ( Plaque Index/Bleeding Index ) , probing depths , and marginal bone levels were recorded for both groups after MI insertions and 6 , 12 , 24 , and 36 months thereafter .
-RESULTS	The cumulative implant survival rates were 91.7 % and 96.7 % for G1 and G2 , respectively .
-RESULTS	G1 recorded significantly higher Plaque Index , Bleeding Index , and probing depths than G2 after 12 months , while other observation times demonstrated no significant difference between groups .
-RESULTS	Most of the recorded marginal bone loss occurred in the first year , and no significant bone loss was noted in subsequent years .
-RESULTS	After 6 months , marginal bone loss was significantly higher in G1 compared to G2 , but no significant differences between groups were noted thereafter .
-CONCLUSIONS	Within the limitations of this study 's research design and duration of follow-up outcome analyses , immediate and early loading protocols showed good clinical results with favorable peri-implant tissue response 3 years after implant insertion .
-CONCLUSIONS	Early loading of MIs supporting a mandibular overdenture appears to be preferable to immediate loading .
-
-###24627290
-OBJECTIVE	Gemigliptin is a novel dipeptidyl peptidase-4 ( DPP-4 ) inhibitor used in the treatment of type 2 diabetes mellitus .
-OBJECTIVE	This study evaluated possible pharmacodynamic and pharmacokinetic interactions between gemigliptin and metformin and investigated their tolerability .
-METHODS	A randomized , open-label , multiple-dose , three-treatment , three-period , three-sequence crossover study was conducted in healthy male subjects .
-METHODS	Twenty-seven subjects received gemigliptin ( 50mg once daily ) , metformin ( 1,000 mg twice a day ) , or both drugs for 7days per dosing period .
-METHODS	Blood samples were drawn over 24h on the seventh day of each period for pharmacokinetic and pharmacodynamic evaluations , including plasma DPP-4 activity and total/active glucagon-like peptide-1 ( GLP-1 ) levels .
-METHODS	Meal tolerance tests were conducted for pharmacodynamic assessment on the eighth day .
-METHODS	Safety and tolerability were evaluated using adverse events , vital signs , ECGs , and clinical laboratory tests .
-RESULTS	Coadministration of gemigliptin and metformin had no significant effect on the pharmacokinetics of gemigliptin or metformin .
-RESULTS	The inhibition of DPP-4 by gemigliptin was not affected by coadministration with metformin .
-RESULTS	Co-therapy of gemigliptin and metformin showed additional effects by increasing plasma active GLP-1 concentrations and lowering serum glucose levels .
-RESULTS	The plasma glucagon level was lower in co-therapy than with metformin monotherapy .
-RESULTS	The coadministration of gemigliptin and metformin was well-tolerated without serious adverse events .
-CONCLUSIONS	Coadministration of gemigliptin and metformin showed beneficial anti-diabetic effects without pharmacokinetic drug-drug interactions .
-
-###24898680
-BACKGROUND	The purpose of the PROLUCA study is to investigate the efficacy of preoperative and early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer with special focus on exercise .
-METHODS	Using a 2 x 2 factorial design with continuous effect endpoint ( Maximal Oxygen Uptake ( VO2peak ) ) , 380 patients with non-small cell lung cancer ( NSCLC ) stage I-IIIa referred for surgical resection will be randomly assigned to one of four groups : ( 1 ) preoperative and early postoperative rehabilitation ( starting two weeks after surgery ) ; ( 2 ) preoperative and late postoperative rehabilitation ( starting six weeks after surgery ) ; ( 3 ) early postoperative rehabilitation alone ; ( 4 ) today 's standard care which is postoperative rehabilitation initiated six weeks after surgery .
-METHODS	The preoperative rehabilitation program consists of an individually designed , 30-minute home-based exercise program performed daily .
-METHODS	The postoperative rehabilitation program consists of a supervised group exercise program comprising cardiovascular and resistance training two-hour weekly for 12 weeks combined with individual counseling .
-METHODS	The primary study endpoint is VO2peak and secondary endpoints include : Six-minute walk distance ( 6MWD ) , one-repetition-maximum ( 1RM ) , pulmonary function , patient-reported outcomes ( PROs ) on health-related quality of life ( HRQoL ) , symptoms and side effects of the cancer disease and the treatment of the disease , anxiety , depression , wellbeing , lifestyle , hospitalization time , sick leave , work status , postoperative complications ( up to 30 days after surgery ) and survival .
-METHODS	Endpoints will be assessed at baseline , the day before surgery , pre-intervention , post-intervention , six months after surgery and one year after surgery .
-CONCLUSIONS	The results of the PROLUCA study may potentially contribute to the identification of the optimal perioperative rehabilitation for operable lung cancer patients focusing on exercise initiated immediately after diagnosis and rehabilitation shortly after surgery .
-BACKGROUND	NCT01893580 .
-
-###25736132
-OBJECTIVE	To investigate the safety and feasibility of domestically made endoscopic stapling instrument in laparoscopic assisted rectal cancer resection ( Dixon ) .
-METHODS	Sixty-four patients with rectal cancer were randomly divided into the research group ( 35 cases ) to receive laparoscopic assisted rectal cancer resection using ENDO RLC general endoscopic linear cutter and single-use loading unit and circular staplers with staples ( from REACH medical equipment co.LTD ) and the control group ( 29 cases ) to receive surgery with the corresponding products widely used ( fom Johnson and Johnson Medical Euipment C.Ltd ) .
-METHODS	The clinical data of the two groups were compared .
-RESULTS	Satisfactory therapeutic effects were obtained in all the cases .
-RESULTS	The two groups showed no significant differences in the operative time , intraoperative anastomosis success rate , or postoperative complications ( anastomotic bleeding , leakage , or stricture ) between the two groups ( P > 0.05 ) , but the average cost of endoscopic stapling instrument was significantly lower in the research group ( 6604.31 699.95 vs 7822.28 576.98 RMB Yuan , P < 0.05 ) .
-CONCLUSIONS	The domestic endoscopic stapling instrument is safe , effective and less costly for laparoscopic assisted rectal cancer resection .
-
-###25647781
-OBJECTIVE	Axitinib is a potent and selective inhibitor of vascular endothelial growth factor receptors 1-3 .
-OBJECTIVE	This analysis compared efficacy and safety of axitinib plus gemcitabine in patients with advanced pancreatic cancer from Japan , North America and the European Union , enrolled in a randomized Phase III study .
-METHODS	Patients ( n = 632 ) , stratified by disease extent , were randomly assigned ( 1:1 ) to receive axitinib/gemcitabine or placebo/gemcitabine .
-METHODS	Axitinib was administered at a starting dose of 5 mg orally twice daily and gemcitabine at 1000 mg/m ( 2 ) once weekly for 3 weeks in 4 week cycles .
-METHODS	Primary endpoint was overall survival .
-RESULTS	Among Japanese patients , median overall survival was not estimable ( 95 % confidence interval , 7.4 months-not estimable ) with axitinib/gemcitabine ( n = 58 ) and 9.9 months ( 95 % confidence interval , 7.4-10 .5 ) with placebo/gemcitabine ( n = 56 ) ( hazard ratio 1.093 [ 95 % confidence interval , 0.525-2 .274 ] ) .
-RESULTS	Median survival follow-up ( range ) was 5.1 months ( 0.02-12 .3 ) with axitinib/gemcitabine vs. 5.4 months ( 1.8-10 .5 ) with placebo/gemcitabine .
-RESULTS	Similarly , no difference was detected in overall survival between axitinib/gemcitabine and placebo/gemcitabine in patients from North America or the European Union .
-RESULTS	Common adverse events with axitinib/gemcitabine in Japanese patients were fatigue , anorexia , dysphonia , nausea and decreased platelet count .
-RESULTS	Axitinib safety profile was generally similar in patients from the three regions , although there were differences in incidence of some adverse events .
-RESULTS	An exploratory analysis did not show any correlation between axitinib/gemcitabine-related hypertension and overall survival .
-CONCLUSIONS	Axitinib/gemcitabine , while tolerated , did not provide survival benefit over gemcitabine alone in patients with advanced pancreatic cancer from Japan or other regions .
-
-###24507404
-OBJECTIVE	Bypass Angioplasty Revascularization Investigation 2 Diabetes ( BARI 2D ) was a study of management strategies for diabetic patients with myocardial ischemia and coronary artery disease .
-OBJECTIVE	In a 22 design , early revascularization versus medical management with or without late revascularization and insulin sensitization versus insulin provision were examined .
-OBJECTIVE	No advantage for either strategy was seen , except in the group undergoing early coronary artery bypass grafting ( CABG ) .
-OBJECTIVE	In that group , a reduction in subsequent myocardial infarction was noted .
-OBJECTIVE	The purpose of our report was to characterize the conduct and short-term outcomes for CABG that led to this result .
-METHODS	Data from the BARI 2D CABG stratum were collected , including the baseline demographic and cardiovascular characteristics , technical details of the operation , and perioperative morbidity and mortality , and analyzed .
-RESULTS	A total of 347 patients were studied .
-RESULTS	The average cardiac function was normal , and most had multivessel disease .
-RESULTS	Almost all had undergone CABG by way of a median sternotomy using an internal mammary artery , and one third were off pump .
-RESULTS	The perioperative morbidity and mortality were low and compared well with larger outcomes databases .
-CONCLUSIONS	BARI 2D showed that early CABG in patients with type 2 diabetes and myocardial ischemia and multivessel disease reduced the subsequent myocardial infarction rates .
-CONCLUSIONS	The present results have demonstrated that this was achieved using off-pump surgery in certain cases , standard myocardial protection , and routine use of the internal mammary artery or other arterial grafts .
-
-###25236611
-BACKGROUND	Interpretive front-of-pack nutrition labels are better understood than non-interpretive labels .
-BACKGROUND	However , robust evidence on the effects of such labels on consumer food purchases in the real-world is lacking .
-BACKGROUND	Our aim is to assess the effects of two interpretive front-of-pack nutrition labels , compared with a non-interpretive label , on the healthiness of consumer food purchases .
-METHODS	A five-week ( 1-week baseline and 4-week intervention ) three-arm parallel randomised controlled trial will be conducted using a bespoke smartphone application , which will administer study questionnaires and deliver intervention ( Multiple Traffic Light and Health Star Rating ) and control ( Nutrition Information Panel ) labels .
-METHODS	To view their allocated nutrition label , participants scan the barcode of packaged food products using their smartphone camera .
-METHODS	The assigned label is displayed instantly on the smartphone screen .1500 eligible participants ( New Zealand adult smartphone owners who shop in a supermarket at least once a week and are main household shoppers ) will be randomised in a 1:1:1 ratio to one of the three nutrition label formats , using computer-generated randomisation sequences .
-METHODS	Randomisation will be stratified by ethnicity and interest in healthy eating .
-METHODS	Food and beverage purchase data will be collected continuously throughout the study via hard copy till receipts and electronic grocery purchase lists recorded and transmitted using the smartphone application .
-METHODS	The primary outcome will be healthiness of food purchases in each trial arm , assessed as mean Food Standards Australia New Zealand nutrient profiling score criterion score for all food and beverages purchased over the intervention period .
-METHODS	Secondary outcomes will include saturated fat , sugar , sodium and energy content of food purchases ; food expenditure ; labelling profile of food purchases ( i.e. mean number of Health Star Rating stars and proportion of red , green and amber traffic lights ) ; nutrient profiling score over time and by food categories ; purchases of unpackaged foods ; self-reported nutrition knowledge and recorded use of assigned labelling system .
-CONCLUSIONS	The Starlight randomised , controlled trial will determine the effects of interpretive front-of-pack nutrition labels on the healthiness of consumer food purchases in the real world .
-BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12614000644662 ( registered 18 June 2014 ) .
-
-###24884942
-BACKGROUND	A gene-based estimate of lung cancer risk in smokers has been shown to act as a smoking cessation motivator in hospital recruited subjects .
-BACKGROUND	The objective of this trial is to determine if this motivator is as effective in subjects recruited from an NHS primary care unit .
-METHODS	Subjects will be recruited by mailings using smoking entries on the GP electronic data-base ( total practice population = 32,048 ) to identify smokers who may want to quit .
-METHODS	Smoking cessation clinics based on medical centre premises will run for eight weeks .
-METHODS	Clinics will be randomised to have the gene-based test for estimation of lung cancer risk or to act as controls groups .
-METHODS	The primary endpoint will be smoking cessation at eight weeks and six months .
-METHODS	Secondary outcomes will include ranking of the gene-based test with other smoking cessation motivators .
-CONCLUSIONS	The results will inform as to whether the gene-based test is both effective as motivator and acceptable to subjects recruited from primary care .
-BACKGROUND	Registered with Clinical Trials.gov ,
-BACKGROUND	NCT01176383 .
-
-###25537303
-BACKGROUND	Acid suppressant drugs are a mainstay of treatment for cats with gastrointestinal erosion and ulceration .
-BACKGROUND	However , clinical studies have not been performed to compare the efficacy of commonly PO administered acid suppressants in cats .
-OBJECTIVE	To compare the effect of PO administered famotidine , fractionated omeprazole tablet ( fOT ) , and omeprazole reformulated paste ( ORP ) on intragastric pH in cats .
-OBJECTIVE	We hypothesized that both omeprazole formulations would be superior to famotidine and placebo .
-METHODS	Six healthy adult DSH colony cats .
-METHODS	Utilizing a randomized , 4-way crossover design , cats received 0.88-1 .26 mg/kg PO q12h fOT , ORP , famotidine , and placebo ( lactose capsules ) .
-METHODS	Intragastric pH monitoring was used to continuously record intragastric pH for 96 hours beginning on day 4 of treatment .
-METHODS	Plasma omeprazole concentrations at steady state ( day 7 ) were determined by high performance liquid chromatography ( HPLC ) with ultraviolet detection .
-METHODS	Mean percentage time that intragastric pH was 3 and 4 were compared among groups using ANOVA with a posthoc Tukey-Kramer test ( = 0.05 ) .
-RESULTS	The mean percentage time SD that intragastric pH was 3 was 68.4 35.0 % for fOT , 73.9 23.2 % for ORP , 42.8 18.6 % for famotidine , and 16.0 14.2 % for placebo .
-RESULTS	Mean SD plasma omeprazole concentrations were similar in cats receiving fOT compared to those receiving ORP and in a range associated with acid suppression reported in other studies .
-CONCLUSIONS	These results suggest that both omeprazole formulations provide superior acid suppression in cats compared to famotidine or placebo .
-CONCLUSIONS	Fractionated enteric-coated OT is an effective acid suppressant despite disruption of the enteric coating .
-
-###24335016
-BACKGROUND	Recent publications show that heat-mediated tissue tightening is a promising treatment for the lax abdomen and may provide better long-term outcomes than traditional suction-assisted liposuction ( SAL ) .
-OBJECTIVE	The author evaluates the degree and duration of skin surface area contraction , as well as the influence of anatomic location of the treatment region on the degree of tissue tightening , in a study comparing SAL alone vs SAL plus radiofrequency-assisted liposuction ( RFAL ) .
-METHODS	In this prospective , randomized , split abdominal study , 12 consecutive patients were treated with SAL alone on 1 side and with SAL plus RFAL on the other side .
-METHODS	Each patient had 4 ( 3 3-cm ) squares-2 per treatment type-tattooed in the lower abdominal region ( 2 on the right and 2 on the left ) .
-METHODS	The surface area of these squares was measured with the Vectra computerized measurement system ( Canfield , Inc , Fairfield , New Jersey ) at pretreatment , at 6 weeks posttreatment , and at 1 year posttreatment .
-METHODS	All measurements were subjected to statistical analysis using predictive analytic software and were evaluated for statistical significance .
-RESULTS	In regions treated with SAL alone , there was a 10.4 % mean skin surface area contraction at 6 weeks and 8.3 % at 1 year posttreatment .
-RESULTS	The mean skin surface area reduction was 25.8 % in regions treated with radiofrequency plus SAL at 6 weeks and at 1 year .
-RESULTS	The anatomic location of each square ( medial vs lateral ) did not statistically correlate with more or less tissue tightening .
-CONCLUSIONS	Radiofrequency-assisted tissue tightening , when applied in conjunction with SAL , is effective in achieving greater skin surface area reduction .
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-###25431855
-OBJECTIVE	Inhalation therapy is the main treatment for asthma and its adequate use has been a factor responsible for disease control ; therefore , the aim of the study was to determine whether a digital media tool , which features portability on mobile phones , modifies the assimilation of the inhalation technique .
-METHODS	A total of 66 professionals working in the health care area with the pediatric population were selected .
-METHODS	They were submitted to a pre-test on their knowledge of inhalation therapy .
-METHODS	The professionals were randomized into two groups ( A and B ) .
-METHODS	Group A received a media application on their mobile phones showing the steps of inhalation therapy , while group B received the same information in written form only .
-METHODS	A post-test was applied after 15 days .
-METHODS	The results ( pre - and post - ) were analyzed by two pediatric pulmonologists .
-RESULTS	Of the 66 professionals , 87.9 % were females .
-RESULTS	Of a total possible score of ten , the mean score obtained in the pre-test was 5.3 3 , and in the second test , 7.5 2 ( p < 0.000 ) .
-RESULTS	There were no significant differences when comparing the two groups ( p = 0.726 ) .
-RESULTS	The nurses had the lowest mean scores in the initial test ( 2.3 2 ) ; however , they were the group that learned the most with the intervention , showing similar means to those of other groups in the second test ( 6.1 3 ) .
-CONCLUSIONS	There was significant improvement in knowledge about inhalation therapy in all professional categories using both methods , demonstrating that education , when available to professionals , positively modifies medical practice .
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-###24625934
-BACKGROUND	Succinylcholine a depolarizing muscle relaxant with rapid onset , predictable course and short duration of action is associated with myalgia .
-OBJECTIVE	The aim of this study is to evaluate the efficacy of pregabalin , gabapentin and diclofenac on the incidence and severity of succinylcholine-induced myalgia .
-METHODS	Tertiary Care Teaching Hospital .
-METHODS	A total of 120 patients undergoing laparoscopic cholecystectomy were randomly assigned into three groups : Pregabalin group received 150 mg of pregabalin , gabapentin group received 600 mg of gabapentin and diclofenac group received 100 mg of diclofenac sodium orally 2 h prior to surgery .
-METHODS	Anesthesia was induced with fentanyl 3 g/kg , propofol 2-2 .5 mg/kg and succinylcholine 1.5 mg/kg and was maintained with oxygen with sevoflurane in the air and intermittent vecuronium bromide .
-METHODS	A blinded observer recorded post-operative pain scores on visual analog scale at different time intervals and myalgia at 24 h. Post-operative pain relief was provided with fentanyl based patient-controlled analgesia .
-METHODS	Fentanyl consumption in 24 h was recorded as a primary outcome .
-METHODS	Patients ' characteristics and total fentanyl consumption were compared using one-way ANOVA followed by post-hoc test .
-METHODS	Pain score was compared amongst the groups using Kruskal Wallis test .
-RESULTS	The myalgia occurred in 15 , 14 and 13 patients in pregabalin , gabapentin and diclofenac sodium group respectively ( P > 0.85 ) .
-RESULTS	Patients in diclofenac group had significantly higher fentanyl consumption ( 674.85 115.58 g ) compared with pregabalin group ( 601.87 129.57 g ) ( 95 % confidence interval [ CI ] = 34.8-120 .7 ) and gabapentin group ( 612.29 105.12 g ) ( 95 % CI = 14.9-170 .5 ) .
-RESULTS	However , there was no significant difference in fentanyl consumption between pregabalin and gabapentin groups ( 95 % CI = -34.8 -120.7 ) .
-RESULTS	There was a significant difference in visual analog score at time points 12 , 18 and 24 h among the study groups .
-CONCLUSIONS	Pre-treatment with pregabalin , gabapentin and diclofenac had equal efficacy in reducing the incidence and severity of succinylcholine-induced myalgia .
-CONCLUSIONS	However , pre-treatment with pregabalin and gabapentin decreased post-operative pain scores and fentanyl consumption .
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-###25488084
-OBJECTIVE	To undertake a five year follow up of a cohort of women and children delivered by forceps or vacuum extractor in a randomised controlled study .
-METHODS	Follow up of a randomised controlled trial .
-METHODS	District general hospital in the West Midlands .
-METHODS	Follow up questionnaires were sent to 306 of the 313 women originally recruited at the North Staffordshire Hospital to a randomised controlled study comparing forceps and vacuum extractor for assisted delivery .
-METHODS	Two hundred and twenty-eight women responded ( 74.5 % ) and all were included in the study ; forceps ( n = 115 ) and vacuum extractor ( n = 113 ) .
-METHODS	Bowel and urinary dysfunction , child vision assessment , and child development .
-RESULTS	Maternal adverse symptoms at long term follow up were relatively common .
-RESULTS	Urinary incontinence of various severity was reported by 47 % , bowel habit urgency was reported by 44 % ( 98/225 ) , and loss of bowel control ` sometimes ' or ` frequently ' by 20 % of women ( 46/226 ) .
-RESULTS	No significant differences between instruments were found in terms of either bowel or urinary dysfunction .
-RESULTS	Overall , 13 % ( 20/158 ) of children were noted to have visual problems .
-RESULTS	There was no significant difference in visual function between the two groups : ventouse 11/86 ( 12.8 % ) , compared with forceps 9/72 ( 12.5 % ) ; odds ratio 0.97 , 95 % CI 0.38-2 .50 .
-RESULTS	Of the 20 children with visual problems , a family history was known in 18 , and 17/18 ( 94 % ) had a positive family history for visual problems .
-RESULTS	No significant differences in child development were found between the two groups .
-CONCLUSIONS	There is no evidence to suggest that at five years after delivery use of the ventouse or forceps has specific maternal or child benefits or side effects .
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-###24818633
-BACKGROUND	Recently , we documented the likely non-inferiority of Combinatietherapie Bij Reumatode Artritis ( COBRA ) - light therapy ( methotrexate increased to 25mg/week with initial prednisolone 30mg/day ) compared with the original COBRA therapy ( methotrexate 7.5 mg/week , sulfasalazine 2g/day , with initial prednisolone 60mg/day ) after 26weeks in patients with early active rheumatoid arthritis ( RA ) .
-OBJECTIVE	To assess the non-inferiority of COBRA-light versus COBRA after 1year in terms of disease activity ( DAS44 ) , functional outcome ( Health Assessment Questionnaire ( HAQ ) ) and radiographic progression ( Sharp/van der Heijde score ( SHS ) ) , and to assess the effect of adding etanercept .
-METHODS	An open-label , randomised controlled , non-inferiority trial of 162 patients with active early RA , following a treat-to-target protocol incorporating the addition of etanercept if DAS44 1.6 at weeks 26 or 39 .
-RESULTS	Both groups showed major improvements in DAS44 after 52weeks : mean ( SD ) -2.41 ( 1.2 ) in the COBRA and -2.02 ( 1.0 ) in the COBRA-light group ( p = ns ) .
-RESULTS	In both groups , functional ability improved and radiological progression of joints was minimal .
-RESULTS	At least one adverse event was reported in 96 % of the patients in both groups .
-RESULTS	In total , 25 serious adverse events occurred : 9 vs 16 in COBRA and COBRA-light , respectively .
-RESULTS	Treatment actually instituted was often less intensive than required by the protocol : of the total population , 108 patients ( 67 % ) required etanercept ( more in the COBRA-light group ) , but only 67 of these ( 62 % ) actually received it .
-CONCLUSIONS	Intensive COBRA or COBRA-light therapy has major , comparably favourable effects on disease activity , functional ability and radiological outcome after 1year in patients with early RA .
-CONCLUSIONS	Protocolised addition of etanercept was often not implemented by treating rheumatologists , and patients receiving it appeared to have limited added benefit , probably because of low disease activity levels at its initiation .
-BACKGROUND	ISRCTN55552928 .
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-###24468198
-OBJECTIVE	This study compared time-to-hospitalization among subjects enrolled in different diabetes self-management programs ( DSMP ) .
-OBJECTIVE	We sought to determine whether the interventions delayed the occurrence of any acute event necessitating hospitalization .
-METHODS	Electronic medical records ( EMR ) were obtained for 376 adults enrolled in a randomized controlled trial ( RCT ) of Type 2 diabetes ( T2DM ) self-management programs .
-METHODS	All study participants had uncontrolled diabetes and were randomized into either : personal digital assistant ( PDA ) , Chronic Disease Self-Management Program ( CDSMP ) , combined PDA and CDSMP ( COM ) , or usual care ( UC ) groups .
-METHODS	Subjects were followed for a maximum of two years .
-METHODS	Time-to-hospitalization was measured as the interval between study enrollment and the occurrence of a diabetes-related hospitalization .
-RESULTS	Subjects enrolled in the CDSMP-only arm had significantly prolonged time-to-hospitalization ( Hazard ratio : 0.10 ; p = 0.002 ) when compared to subjects in the control arm .
-RESULTS	Subjects in the PDA-only and combined PDA and CDSMP arms showed no improvements in comparison to the control arm .
-CONCLUSIONS	CDSMP can be effective in delaying time-to-hospitalization among patients with T2DM .
-CONCLUSIONS	Reducing unnecessary healthcare utilization , particularly inpatient hospitalization is a key strategy to improving the quality of health care and lowering associated health care costs .
-CONCLUSIONS	The CDSMP offers the potential to reduce time-to-hospitalization among T2DM patients .
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-###25788230
-BACKGROUND	The benefit of CT coronary angiography ( CTCA ) in patients presenting with stable chest pain has not been systematically studied .
-BACKGROUND	We aimed to assess the effect of CTCA on the diagnosis , management , and outcome of patients referred to the cardiology clinic with suspected angina due to coronary heart disease .
-METHODS	In this prospective open-label , parallel-group , multicentre trial , we recruited patients aged 18-75 years referred for the assessment of suspected angina due to coronary heart disease from 12 cardiology chest pain clinics across Scotland .
-METHODS	We randomly assigned ( 1:1 ) participants to standard care plus CTCA or standard care alone .
-METHODS	Randomisation was done with a web-based service to ensure allocation concealment .
-METHODS	The primary endpoint was certainty of the diagnosis of angina secondary to coronary heart disease at 6 weeks .
-METHODS	All analyses were intention to treat , and patients were analysed in the group they were allocated to , irrespective of compliance with scanning .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT01149590 .
-RESULTS	Between Nov 18 , 2010 , and Sept 24 , 2014 , we randomly assigned 4146 ( 42 % ) of 9849 patients who had been referred for assessment of suspected angina due to coronary heart disease .
-RESULTS	47 % of participants had a baseline clinic diagnosis of coronary heart disease and 36 % had angina due to coronary heart disease .
-RESULTS	At 6 weeks , CTCA reclassified the diagnosis of coronary heart disease in 558 ( 27 % ) patients and the diagnosis of angina due to coronary heart disease in 481 ( 23 % ) patients ( standard care 22 [ 1 % ] and 23 [ 1 % ] ; p < 00001 ) .
-RESULTS	Although both the certainty ( relative risk [ RR ] 256 , 95 % CI 233-279 ; p < 00001 ) and frequency of coronary heart disease increased ( 109 , 102-117 ; p = 00172 ) , the certainty increased ( 179 , 162-196 ; p < 00001 ) and frequency seemed to decrease ( 093 , 085-102 ; p = 01289 ) for the diagnosis of angina due to coronary heart disease .
-RESULTS	This changed planned investigations ( 15 % vs 1 % ; p < 00001 ) and treatments ( 23 % vs 5 % ; p < 00001 ) but did not affect 6-week symptom severity or subsequent admittances to hospital for chest pain .
-RESULTS	After 17 years , CTCA was associated with a 38 % reduction in fatal and non-fatal myocardial infarction ( 26 vs 42 , HR 062 , 95 % CI 038-101 ; p = 00527 ) , but this was not significant .
-CONCLUSIONS	In patients with suspected angina due to coronary heart disease , CTCA clarifies the diagnosis , enables targeting of interventions , and might reduce the future risk of myocardial infarction .
-BACKGROUND	The Chief Scientist Office of the Scottish Government Health and Social Care Directorates funded the trial with supplementary awards from Edinburgh and Lothian 's Health Foundation Trust and the Heart Diseases Research Fund .
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-###24392486
-OBJECTIVE	To evaluate the effect of different polymerization sequences employed during application of bis-GMAbased particulate filler composites ( PFC ) or a flowable resin ( FR ) on fiber-reinforced composite ( FRC ) .
-METHODS	Unidirectional , pre-impregnated S2-glass fibers ( Dentapreg ) and multidirectional preimpregnated E-glass fibers ( Dentapreg ) ( length : 40 mm ; thickness : 0.5 mm ) were obtained ( N = 144 , n = 12 per group ) and embedded in translucent silicone material with the adhesion surface exposed .
-METHODS	The resulting specimens were randomly divided into 12 groups for the following application sequences : a ) FRC+PFC ( photopolymerized in one step ) , b ) FRC+FR ( photopolymerized in one step ) , c ) FRC+PFC ( photopolymerized individually ) , d ) FRC+FR ( photopolymerized individually ) , e ) FRC ( photopolymerized ) + intermediate adhesive resin and PFC ( photopolymerized in one step ) , f ) FRC ( photopolymerized ) + intermediate adhesive resin and FR ( photopolymerized in one step ) .
-METHODS	The sequences of unidirectional ( groups a to f ) were repeated for multidirectional ( groups g to l ) FRCs .
-METHODS	PFCs were debonded from the FRC surfaces using the shear bond test in a universal testing machine ( 1 mm/min ) .
-METHODS	On additional specimens from each FRC type , thermogravimetric analysis ( TGA ) was performed to characterize the fiber weight content ( Wf ) ( N = 6 , n = 3 per group ) .
-METHODS	After debonding , all specimens were analyzed using SEM to categorize the failure modes .
-METHODS	The data were statistically analyzed using 3-way ANOVA and Tukey 's tests ( = 0.05 ) .
-RESULTS	Significant effects of the FRC type ( S2 or E-glass ) ( p < 0.01 ) , resin type ( PFC or FR ) ( p < 0.01 ) and polymerization protocol ( p < 0.05 ) were observed on the bond strength ( MPa ) .
-RESULTS	Interaction terms were also significant ( p < 0.05 ) .
-RESULTS	The multidirectional FRC groups ( g to l ) showed significantly lower bond strengths ( 2.3 0.2 to 7.3 0.3 MPa ) than did the unidirectional FRC groups ( a to f ) ( 10.7 0.6 to 24.4 0.8 MPa ) .
-RESULTS	Among the unidirectional FRC groups , the highest values were obtained with protocol f ( 24.4 0.8 ) , followed by protocol e ( 18.6 0.4 ) .
-RESULTS	PFC adhesion to unidirectional FRC was lower when FRC and PFC were polymerized in one step ( protocol a : 11.3 0.5 ) than individual polymerization ( protocol c : 14.1 0.5 ) .
-RESULTS	The opposite situation was true for FR ( protocol b : 17.5 0.4 ; protocol d : 10.7 0.6 ) .
-RESULTS	Groups a to f presented exclusively mixed failures ( a combination of partial cohesive failure in the PFC and adhesive failure between the FRC and PFC ) and groups g to l demonstrated only adhesive failure ( intact FRC no cohesive failure of PFC ) .
-RESULTS	TGA revealed 55 3 wt % fiber content for multidirectional and 60 3 wt % for unidirectional FRCs tested .
-CONCLUSIONS	Multidirectional pre-impregnated E-glass fibers can not be recommended in combination with the PFC and FR materials tested in this study .
-CONCLUSIONS	Application of an intermediate adhesive resin layer increases the adhesion of both PFC and FR to unidirectional FRC .
-CONCLUSIONS	FRC and FR can be polymerized in one step , but FRC and PFC combinations should be polymerized individually .
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-###25074387
-BACKGROUND	Medium chain triglycerides ( MCT ) enhance thermogenesis and may reduce food intake relative to long chain triglycerides ( LCT ) .
-BACKGROUND	The goal of this study was to establish the effects of MCT on appetite and food intake and determine whether differences were due to differences in hormone concentrations .
-METHODS	Two randomized , crossover studies were conducted in which overweight men consumed 20g of MCT or corn oil ( LCT ) at breakfast .
-METHODS	Blood samples were obtained over 3h .
-METHODS	In Study 1 ( n = 10 ) , an ad lib lunch was served after 3h .
-METHODS	In Study 2 ( n = 7 ) , a preload containing 10g of test oil was given at 3h and lunch was served 1h later .
-METHODS	Linear mixed model analyses were performed to determine the effects of MCT and LCT oil on change in hormones and metabolites from fasting , adjusting for body weight .
-METHODS	Correlations were computed between differences in hormones just before the test meals and differences in intakes after the two oils for Study 1 only .
-RESULTS	Food intake at the lunch test meal after the MCT preload ( Study 2 ) was ( means.e.m . )
-RESULTS	532389kcal vs 804486kcal after LCT ( P < 0.05 ) .
-RESULTS	MCT consumption resulted in a lower rise in triglycerides ( P = 0.014 ) and glucose ( P = 0.066 ) and a higher rise in peptide YY ( PYY , P = 0.017 ) and leptin ( P = 0.036 ) compared with LCT ( combined data ) .
-RESULTS	Correlations between differences in hormone levels ( glucagon-like peptide ( GLP-1 ) , PYY ) and differences in food intake were in the opposite direction to expectations .
-CONCLUSIONS	MCT consumption reduced food intake acutely but this does not seem to be mediated by changes in GLP-1 , PYY and insulin .
-
-###25304255
-BACKGROUND	High-risk prescribing in primary care is common and causes considerable harm .
-BACKGROUND	Feedback interventions have small/moderate effects on clinical practice , but few trials explicitly compare different forms of feedback .
-BACKGROUND	There is growing recognition that intervention development should be theory-informed , and that comprehensive reporting of intervention design is required by potential users of trial findings .
-BACKGROUND	The paper describes intervention development for the Effective Feedback to Improve Primary Care Prescribing Safety ( EFIPPS ) study , a pragmatic three-arm cluster randomised trial in 262 Scottish general practices .
-METHODS	The NHS chose to implement a feedback intervention to utilise a new resource , new Prescribing Information System ( newPIS ) .
-METHODS	The development phase required selection of high-risk prescribing outcome measures and design of intervention components : ( 1 ) educational material ( the usual care comparison ) , ( 2 ) feedback of practice rates of high-risk prescribing received by both intervention arms and ( 3 ) a theory-informed behaviour change component to be received by one intervention arm .
-METHODS	Outcome measures , educational material and feedback design , were developed with a National Health Service Advisory Group .
-METHODS	The behaviour change component was informed by the Theory of Planned Behaviour and the Health Action Process Approach .
-METHODS	A focus group elicitation study and an email Delphi study with general practitioners ( GPs ) identified key attitudes and barriers of responding to the prescribing feedback .
-METHODS	Behaviour change techniques were mapped to the psychological constructs , and the content was informed by the results of the elicitation and Delphi study .
-RESULTS	Six high-risk prescribing measures were selected in a consensus process based on importance and feasibility .
-RESULTS	Educational material and feedback design were based on current NHS Scotland practice and Advisory Group recommendations .
-RESULTS	The behaviour change component was resource constrained in development , mirroring what is feasible in an NHS context .
-RESULTS	Four behaviour change interventions were developed and embedded in five quarterly rounds of feedback targeting attitudes , subjective norms , perceived behavioural control and action planning ( 2 ) .
-CONCLUSIONS	The paper describes a process which is feasible to use in the resource-constrained environment of NHS-led intervention development and documents the intervention to make its design and implementation explicit to potential users of the trial findings .
-BACKGROUND	ClinicalTrials.gov : NCT01602705 .
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-###25409167
-OBJECTIVE	Rectal nonsteroidal anti-inflammatory drugs have been shown to reduce the incidence of postendoscopic retrograde cholangiopancreatography ( ERCP ) pancreatitis ( PEP ) .
-OBJECTIVE	The aim of this study was to determine whether intramuscular diclofenac reduces the risk of PEP .
-METHODS	Patients who underwent ERCP were randomized to receive either 90mg of diclofenac or placebo by intramuscular injection immediately after the procedure .
-METHODS	PEP was defined as elevated serum amylase levels ( at least three times the upper limit of normal 24 hours after the procedure ) associated with new or worsened upper abdominal , epigastric , or back pain .
-RESULTS	In total , 380 patients were randomized , and 343 were eligible for analysis .
-RESULTS	The two groups were similar regarding clinical and demographic factors , as well as patient - and procedure-related risk factors for PEP .
-RESULTS	PEP developed in 20/170 patients ( 11.8 % ) in the placebo group and in 22/173 patients ( 12.7 % ) in the diclofenac group ( P = 0.87 ) .
-RESULTS	Multivariate regression analysis failed to illustrate that intramuscular diclofenac prevented PEP ( odds ratio 0.79 ; 95 % confidence interval 0.39-1 .25 ; P = 0.51 ) .
-CONCLUSIONS	Prophylactic intramuscular diclofenac had no beneficial preventive effect on PEP.Clinicaltrials.gov NCT01717599 .
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-###25891548
-BACKGROUND	Infusion of PDA-001 , a preparation of mesenchymal-like cells derived from full-term human placenta , is a new approach in the treatment of patients with multiple sclerosis .
-OBJECTIVE	This safety study aimed to rule out the possibility of paradoxical exacerbation of disease activity by PDA-001 in patients with multiple sclerosis .
-METHODS	This was a phase 1b , multicenter , randomized , double-blind , placebo-controlled , 2-dose ranging study including patients with relapsing-remitting multiple sclerosis or secondary progressive multiple sclerosis .
-METHODS	The study was conducted at 6 sites in the United States and 2 sites in Canada .
-METHODS	Patients were randomized 3:1 to receive 2 low-dose infusions of PDA-001 ( 15010 ( 6 ) cells ) or placebo , given 1 week apart .
-METHODS	After completing this cohort , subsequent patients received high-dose PDA-001 ( 60010 ( 6 ) cells ) or placebo .
-METHODS	Monthly brain magnetic resonance imaging scans were performed .
-METHODS	The primary end point was ruling out the possibility of paradoxical worsening of MS disease activity .
-METHODS	This was monitored using Cutters rule ( 5 new gadolinium lesions on 2 consecutive scans ) by brain magnetic resonance imaging on a monthly basis for six months and also the frequency of multiple sclerosis relapse .
-RESULTS	Ten patients with relapsing-remitting multiple sclerosis and 6 with secondary progressive multiple sclerosis were randomly assigned to treatment : 6 to low-dose PDA-001 , 6 to high-dose PDA-001 , and 4 to placebo .
-RESULTS	No patient met Cutters rule .
-RESULTS	One patient receiving high-dose PDA-001 had an increase in T2 and gadolinium lesions and in Expanded Disability Status Scale score during a multiple sclerosis flare 5 months after receiving PDA-001 .
-RESULTS	No other patient had an increase in Expanded Disability Status Scale score > 0.5 , and most had stable or decreasing Expanded Disability Status Scale scores .
-RESULTS	With high-dose PDA-001 , 1 patient experienced a grade 1 anaphylactoid reaction and 1 had grade 2 superficial thrombophlebitis .
-RESULTS	Other adverse events were mild to moderate and included headache , fatigue , infusion site reactions , and urinary tract infection .
-CONCLUSIONS	PDA-001 infusions were safe and well tolerated in relapsing-remitting multiple sclerosis and secondary progressive multiple sclerosis patients .
-CONCLUSIONS	No paradoxical worsening of lesion counts was noted with either dose .
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-###24409075
-OBJECTIVE	To evaluate the efficacy and toxicity of nedaplatin ( NDP ) concurrent with radiotherapy in the treatment of locally advanced esophageal carcinoma .
-METHODS	Sixty-eight patients with locally advanced esophageal carcinoma were randomized into either a NDP group ( n = 34 ) or a cisplatin ( DDP ) group ( n = 34 ) .
-METHODS	The NDP group received NDP 80-100 mg/m iv on day 1 + leucovorin ( CF ) 100 mg/m iv on days 1-5 + 5-fluorouracil ( 5-FU ) 500 mg/m iv on days 1-5 .
-METHODS	The DDP group received DDP 30 mg/m iv on days 1-3 + CF 100 mg/m on days 1-5 + 5-FU 500 mg/m iv on days 1-5 .
-METHODS	The treatment was repeated every 4 wk in both groups .
-METHODS	Concurrent radiotherapy [ 60-66 Gy / ( 30-33 f ) / ( 6-7 wk ) ] was given during chemotherapy .
-RESULTS	There was no significant difference in the short-term response rate between the NDP group and DDP group ( 90.9 % vs 81.3 % , P = 0.528 ) .
-RESULTS	Although the 1 - and 2-year survival rates were higher in the NDP group than in the DDP group ( 75.8 % vs 68.8 % , 57.6 % vs 50.0 % ) , the difference in the overall survival rate was not statistically significant between the two groups ( P = 0.540 ) .
-RESULTS	The incidences of nausea , vomiting and nephrotoxicity were significantly lower in the NDP group than in the DDP group ( 17.6 % vs 50.0 % , P = 0.031 ; 11.8 % vs 47.1 % , P = 0.016 ; 8.8 % vs 38.2 % , P = 0.039 ) .
-RESULTS	There was no significant difference in the incidence of myelosuppression , radiation-induced esophagitis or radiation-induced pneumonia between the two groups .
-CONCLUSIONS	NDP-based concurrent chemoradiotherapy is effective and well-tolerated in patients with locally advanced esophageal carcinoma .
-CONCLUSIONS	NDP-based regimen has comparable efficacy to DDP-based regimen but is associated with lower incidences of gastrointestinal and renal toxicity .
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-###25439340
-OBJECTIVE	A growing body of studies consistently demonstrates that social responsiveness toward others is influenced by the neurohormone oxytocin .
-OBJECTIVE	However , the potential role of oxytocin for self-perception remains relatively unexplored .
-OBJECTIVE	Thus , we investigated whether oxytocin administration influences the self-attribution of positive and negative adjectives at the early , effortful stage of self-related information processing .
-METHODS	Sixty healthy male participants received either 24I .
-METHODS	U. oxytocin or a placebo in a randomized double-blind study before completing a sorting task , in which they were instructed to co-classify , as fast as possible , positive and negative adjectives into either self or non-self categories .
-RESULTS	Oxytocin-treated participants reported stronger positive attitudes toward themselves compared to placebo .
-CONCLUSIONS	The present findings demonstrate that oxytocin administration influences the early stage of self-related information processing and suggests that the oxytocinergic system might be involved in psychopathological conditions characterized by a negative representation of self .
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-###24225379
-OBJECTIVE	Nonarteriitic anterior ischemic optic neuropathy ( NAION ) is a leading cause of sudden loss of vision , which particularly affects individuals older than 50 years .
-OBJECTIVE	Up to now there is no treatment that is effective at reversing or limiting the course of this disease .
-OBJECTIVE	To study the short - and long-term effects of fluocortolone ( FC ) on the visual outcome of patients with acute NAION compared to standard treatment with pentoxifylline ( PFX ) .
-METHODS	A prospective , quasirandomized intervention trial was conducted involving 60 patients with acute-onset NAION .
-METHODS	Patients in the comparison ( PFX ) group ( n = 30 ) received PFX intravenously and per os for 7 days and then per os for a further 6 months , which is a standard treatment .
-METHODS	Patients in the intervention ( PFX + FC ) group ( n = 30 ) received the standard treatment plus 1 mg/kg FC for 5 days , with a subsequent stepwise dose reduction over time .
-METHODS	As a primary outcome measure , the best corrected visual acuity ( BCVA ) was determined at the initial baseline consultation ( i.e. , before treatment ) , and at 3 days and 6 months after therapy onset .
-METHODS	Visual field ( VF ) was analyzed using standard automated perimetry at the initial baseline examination and at 6 month after therapy onset .
-METHODS	Changes in BCVA and visual field in the PFX and PFX + FC groups were compared and analyzed statistically .
-RESULTS	Treatment with FC resulted in a significant improvement in BCVA .
-RESULTS	Patients receiving FC in acute NAION were more likely to experience improvement and less likely to have worsened visual acuity ( mean BCVA scores : at baseline , 0.22 ; after 3 days and 6 months of treatment , 0.33 and 0.43 , respectively ) than PFX patients ( mean BCVA scores : at baseline , 0.33 ; after 3 days and 6 months of treatment , 0.33 and 0.28 , respectively ; p < 0.002 and 0.001 ) .
-RESULTS	The beneficial effect was even more marked 6 months after therapy onset .
-RESULTS	Remarkably , patients with a baseline BCVA score of > = 0.05 profited significantly by FC treatment ( p < 0.006 and 0.001 ) , whereas those with a baseline BCVA score of < 0.05 did not ( p < 0.4 ) .
-RESULTS	PFX did not improve BCVA .
-RESULTS	However , VF did not show any significant improvement due to FC therapy .
-CONCLUSIONS	This is the first prospective randomized intervention trial that demonstrates the distinctive beneficial effects of FC in terms of the visual outcome of patients with NAION compared to standard treatment with only PFX .
-CONCLUSIONS	FC significantly improves both short - and long-term visual acuity in patients with moderate BCVA impairment due to recent onset of NAION , while VF did not show any significant improvement ; however , PFX did neither enhance BCVA nor VF .
-CONCLUSIONS	Administration of FC should be seriously considered for the treatment of NAION whenever there are no contraindications .
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-###24671237
-OBJECTIVE	Currently , there is no consensus concerning the possible beneficial colonic and systemic effects of prebiotic-containing infant formula .
-OBJECTIVE	This study assesses whether the feeding of a galactooligosaccharides ( GOS ) - containing infant formula ( 0.44 g/dl of GOS ) and the subsequent feeding of a GOS-containing follow-on formula ( 0.50 g/dl of GOS ) have a prebiotic effect on intestinal microbiota that helps to decrease infections and allergy manifestations in healthy infants during the first year of life .
-METHODS	A multicentre , randomised , double-blind and placebo-controlled trial was carried out on 365 healthy term infants enrolled before 8 weeks of age and randomly assigned to a formula with or without GOS , until 12 months of age .
-METHODS	The incidence of infections and allergy manifestations , the antibiotics prescribed and faecal characteristics were recorded up to 12 months of age , while faecal samples were collected up to 4 months for the measurement of secretory immunoglobulin A , short-chain fatty acids and microbiota .
-RESULTS	A prebiotic effect on the faecal analysis was observed at 4 months of life .
-RESULTS	The GOS group showed a lower faecal pH ( P = 0.019 ) , a lower decreasing trend in secretory immunoglobulin A ( P = 0.078 ) , lower butyric acid concentration ( P = 0.040 ) and an increase in Bifidobacterium counts ( P = 0.010 ) .
-RESULTS	Changes in faecal characteristics involved greater frequency ( P < 0.001 ) and softer consistency ( P < 0.05 ) .
-RESULTS	The incidence of infections or allergic manifestations during the first year of life was similar in both groups , with no statistical differences ( P > 0.05 ) .
-CONCLUSIONS	The feeding of GOS-containing infant formula produced a definite prebiotic effect consisting of changes in faecal composition and microbiota , and in faecal consistency and the frequency of defaecation .
-CONCLUSIONS	No changes in the incidence of infection or allergic manifestation during the first year of life were observed .
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-###24754911
-BACKGROUND	The Canola Oil Multicenter Intervention Trial ( COMIT ) was a randomized controlled crossover study designed to evaluate the effects of five diets that provided different oils and/or oil blends on cardiovascular disease ( CVD ) risk factors in individuals with abdominal obesity .
-BACKGROUND	The present objective is to report preliminary findings on plasma fatty acid profiles in volunteers with abdominal obesity , following the consumption of diets enriched with n-3 , n-6 and n-9 fatty acids .
-METHODS	COMIT was conducted at three clinical sites , Winnipeg , Manitoba , Canada , Qubec City , Qubec , Canada and University Park , Pennsylvania , United States .
-METHODS	Inclusion criteria were at least one of the followings : waist circumference ( 90 cm for males and 84 cm for females ) , and at least one other criterion : triglycerides 1.7 mmol/L , high density lipoprotein cholesterol < 1 mmol/L ( males ) or < 1.3 mmol/L ( females ) , blood pressure 130 mmHg ( systolic ) and/or 85 mmHg ( diastolic ) , and glucose 5.5 mmol/L .
-METHODS	Weight-maintaining diets that included shakes with one of the dietary oil blends were provided during each of the five 30-day dietary phases .
-METHODS	Dietary phases were separated by four-week washout periods .
-METHODS	Treatment oils were canola oil , high oleic canola oil , high oleic canola oil enriched with docosahexaenoic acid ( DHA ) , flax oil and safflower oil blend , and corn oil and safflower oil blend .
-METHODS	A per protocol approach with a mixed model analysis was decided to be appropriate for data analysis .
-RESULTS	One hundred and seventy volunteers were randomized and 130 completed the study with a dropout rate of 23.5 % .
-RESULTS	The mean plasma total DHA concentrations , which were analyzed among all participants as a measure of adherence , increased by more than 100 % in the DHA-enriched phase , compared to other phases , demonstrating excellent dietary adherence .
-CONCLUSIONS	Recruitment and retention strategies were effective in achieving a sufficient number of participants who completed the study protocol to enable sufficient statistical power to resolve small differences in outcome measures .
-CONCLUSIONS	It is expected that the study will generate important data thereby enhancing our understanding of the effects of n-3 , n-6 , and n-9 fatty acid-containing oils on CVD risks .
-BACKGROUND	ClinicalTrials.gov NCT01351012 .
-
-###24506142
-OBJECTIVE	UK cancer guidelines recommend patients with colonic obstruction due to suspected malignancy be considered for stenting with a self-expanding metal stent ( SEMS ) .
-OBJECTIVE	Considerable variation in practice exists due to a lack of expertise , technical difficulties and other , as yet ill-defined features .
-OBJECTIVE	This retrospective multi-centre study aims to determine the outcome following colonic stenting for large bowel obstruction and identify factors associated with successful intervention .
-METHODS	A regional programme of colonic stenting for large bowel obstruction , in five UK centres from 2005 to 2010 was evaluated for outcome including technical and clinical success , survival , complications and reoperation .
-RESULTS	A SEMS was inserted in 334 patients , including 264 ( 79.0 % ) for palliation and 52 ( 15.6 % ) as a bridge to surgery .
-RESULTS	Technical success was achieved in 292 ( 87.4 % ) patients , with 46 ( 13.8 % ) experiencing a complication or technical failure .
-RESULTS	Reoperation was required in 39 ( 14.8 % ) patients stented for palliation of colorectal cancer of whom 16 ( 6.1 % ) subsequently required a colostomy .
-RESULTS	A one-stage primary anastomosis was achieved in 35 ( 67.3 % ) of the 52 patients undergoing stenting as a bridge to resection .
-RESULTS	Technical success did not vary by indication or site of obstruction ( P = 0.60 ) but was higher for operators who had performed more than 10 procedures ( OR 3.34 , P = 0.001 ) .
-RESULTS	ASA grade 3 predicted a worse clinical outcome ( OR 0.43 , P = 0.04 ) .
-RESULTS	The through-the-scope ( TTS ) endoscopy technique was more successful than radiological placement alone ( 90.3 % vs 74.8 % , P < 0.001 ) .
-CONCLUSIONS	Experienced operators using a TTS technique achieved a better outcome for the emergency management of large bowel obstruction .
-CONCLUSIONS	Older , sicker patients and those with extracolonic and benign strictures fared less well .
-
-###24907703
-OBJECTIVE	The guided outcomes in learned efficiency ( GOLE ) model emphasizes the use of evidence-based resources to understand the diagnosis , treatment , follow-up , and prevention of disease .
-OBJECTIVE	We seek to determine whether presentations created using the GOLE model are superior to an unstructured approach in achieving Accreditation Council for Graduate Medical Education ( ACGME ) Core Competencies .
-METHODS	Consenting medical students were randomized to GOLE or control groups to individually research a self-selected clinical topic .
-METHODS	A validated survey instrument was used prepresentation and postpresentation to assess perceived improvement in knowledge .
-METHODS	Subjects completed self-evaluations at enrollment and after presentation of their chosen clinical topic .
-METHODS	Other students , residents , and a faculty member also completed evaluations after each student presentation .
-METHODS	Standard statistical methods ( analysis of variance , 2-tailed t test ) were used to determine if a statistically significant difference existed between intervention and control groups .
-RESULTS	Self-assessments were similar in the GOLE and control groups .
-RESULTS	Externally perceived presentation scores were greater in the GOLE group ( ACGME global P < .0001 , presentation global P = .07 ) , which demonstrated a significant improvement in 5 core competencies .
-RESULTS	Time spent preparing the presentation and resources utilized did not differ between groups .
-CONCLUSIONS	The presentations prepared using the GOLE model were rated higher by observers than those prepared using traditional techniques .
-
-###25311606
-OBJECTIVE	The neighborhoods in which children live , play , and eat provide an environmental context that may influence obesity risk and ameliorate or exacerbate health disparities .
-OBJECTIVE	The current study examines whether neighborhood characteristics predict obesity in a prospective cohort of girls .
-METHODS	Participants were 174 girls ( aged 8-10 years at baseline ) , a subset from the Cohort Study of Young Girls ' Nutrition , Environment , and Transitions .
-METHODS	Trained observers completed street audits within a 0.25-mile radius around each girl 's residence .
-METHODS	Four scales ( food and service retail , recreation , walkability , and physical disorder ) were created from 40 observed neighborhood features .
-METHODS	BMI was calculated from clinically measured height and weight .
-METHODS	Obesity was defined as BMI-for-age 95 % .
-METHODS	Logistic regression models using generalized estimating equations were used to examine neighborhood influences on obesity risk over 4 years of follow-up , controlling for race/ethnicity , pubertal status , and baseline BMI .
-METHODS	Fully adjusted models also controlled for household income , parent education , and a census tract measure of neighborhood socioeconomic status .
-RESULTS	A 1-SD increase on the food and service retail scale was associated with a 2.27 ( 95 % confidence interval , 1.42 to 3.61 ; P < .001 ) increased odds of being obese .
-RESULTS	A 1-SD increase in physical disorder was associated with a 2.41 ( 95 % confidence interval , 1.31 to 4.44 ; P = .005 ) increased odds of being obese .
-RESULTS	Other neighborhood scales were not associated with risk for obesity .
-CONCLUSIONS	Neighborhood food and retail environment and physical disorder around a girl 's home predict risk for obesity across the transition from late childhood to adolescence .
-
-###25321869
-OBJECTIVE	Cervical total disc replacement ( CTDR ) was developed to treat cervical spondylosis , while preserving motion .
-OBJECTIVE	While anterior cervical discectomy and fusion ( ACDF ) has been the standard of care for 2-level disease , a randomized clinical trial ( RCT ) suggested similar outcomes .
-OBJECTIVE	Cost-effectiveness of this intervention has never been elucidated .
-OBJECTIVE	To determine the cost-effectiveness of CTDR compared with ACDF .
-METHODS	Data were derived from an RCT that followed up 330 patients over 24 months .
-METHODS	The original RCT consisted of multi-institutional data including private and academic institutions .
-METHODS	Using linear regression for the current study , health states were constructed based on the stratification of the Neck Disability Index and a visual analog scale .
-METHODS	Data from the 12-item Short-Form Health Survey questionnaires were transformed into utilities values using the SF-6D mapping algorithm .
-METHODS	Costs were calculated by extracting Diagnosis-Related Group codes from institutional billing data and then applying 2012 Medicare reimbursement rates .
-METHODS	The costs of complications and return-to-work data were also calculated .
-METHODS	A Markov model was built to evaluate quality-adjusted life-years ( QALYs ) for both treatment groups .
-METHODS	The model adopted a third-party payer perspective and applied a 3 % annual discount rate .
-METHODS	Patients included in the original RCT had to be diagnosed as having radiculopathy or myeloradiculopathy at 2 contiguous levels from C3-C7 that was unresponsive to conservative treatment for at least 6 weeks or demonstrated progressive symptoms .
-METHODS	Incremental cost-effectiveness ratio of CTDR compared with ACDF .
-RESULTS	A strong correlation ( R2 = 0.6864 ; P < .001 ) was found by projecting a visual analog scale onto the Neck Disability Index .
-RESULTS	Cervical total disc replacement had an average of 1.58 QALYs after 24 months compared with 1.50 QALYs for ACDF recipients .
-RESULTS	Cervical total disc replacement was associated with $ 2139 greater average cost .
-RESULTS	The incremental cost-effectiveness ratio of CTDR compared with ACDF was $ 24,594 per QALY at 2 years .
-RESULTS	Despite varying input parameters in the sensitivity analysis , the incremental cost-effectiveness ratio value stays below the threshold of $ 50,000 per QALY in most scenarios ( range , - $ 58,194 to $ 147,862 per QALY ) .
-CONCLUSIONS	The incremental cost-effectiveness ratio of CTDR compared with traditional ACDF is lower than the commonly accepted threshold of $ 50,000 per QALY .
-CONCLUSIONS	This remains true with varying input parameters in a robust sensitivity analysis , reaffirming the stability of the model and the sustainability of this intervention .
-
-###24601174
-BACKGROUND	Dipeptidyl peptidase-4 ( DPP-4 ) inhibitors are a new class of antihyperglycemic drugs that block degradation ofincretin hormones .
-OBJECTIVE	To assess the effects oftreatment with DPP-4 inhibitors on glucoregulation and body weight in obese patients with type 2 diabetes mellitus .
-METHODS	The study included 9 females and 9 males with type 2 diabetes ( n = 18 ) , BMI = 31.24 + / - 2,26 kg/m2 , mean age 58 + / - 6,8 years .
-METHODS	The patients have been thoroughly evaluated before treatment , and 6 months after treatment with DPP-4 inhibitor ( sitagliptin ) in combination with metformin .
-RESULTS	After 6 months of treatment with DPP-4 inhibitors in combination with metformin HbAlc ( -1,49 % ) .
-RESULTS	, FBG ( -3.75 mmol/L ) and PBG ( -5.79 mmol/L ) significantly reduced ( p = 0.000 ) .
-RESULTS	Mean body weight also significantly reduced ( -12.5 % ; p = 0.000 ) .
-RESULTS	Reduction of mean fasting insulin was 5.46 mIU/L or 27 % ( p = 0.000 ) .
-RESULTS	Mean HOMA-IR change was -1.64 ( p = 0.000 ) .
-RESULTS	Also there was significant decreasing of systolic blood pressure ( p = 0.001 ) , cholesterol ( p = 0.004 ) , triglycerides ( p = 0.001 ) , LDL ( p = 0.002 ) and increasing of HDL ( p = 0.002 ) .
-RESULTS	Hypoglycaemia was not registered in any of the patients .
-CONCLUSIONS	These results show that in obese patients with type 2 diabetes , DPP-4 inhibitors treatment in combination with metformin was associated with improvements in glycaemic control , and a reduction in body weight .
-
-###24742970
-BACKGROUND	This is a report of a clinical trial on the therapeutic efficacy and safety of combined aliskiren and losartan ( an angiotensin II receptor blocker ( ARB ) ) versus aliskiren alone and ARB alone in non-diabetic chronic kidney disease ( CKD ) over a 3-year period .
-METHODS	This was a randomised trial in 155 patients with non-diabetic CKD comparing aliskiren ( 150 mg/day ) ( n = 52 ) versus losartan ( 100 mg/day ) ( n = 52 ) and the third group aliskiren ( 150 mg/day ) combined with losartan ( 100 mg/day ) ( n = 51 ) .
-METHODS	The trial utilised primary renal end points of eGFR < 15 ml/min or end-stage renal failure .
-RESULTS	All three groups had significant reduction of proteinuria ( p < 0.001 for all ) .
-RESULTS	The changes in eGFR , total urinary protein from baseline to each year were not significantly different between the three therapeutic groups .
-CONCLUSIONS	This study in non-diabetic CKD patients showed that combination therapy with aliskiren and ARB was as efficacious as aliskiren alone and ARB alone .
-CONCLUSIONS	There was one patient who developed a non-fatal stroke in the combined aliskiren and ARB group while the other two groups had none .
-
-###25117466
-OBJECTIVE	Very low density lipoprotein triglyceride ( VLDL-TG ) and free fatty acids ( FFA ) constitute a substantial proportion of human energy supply both at rest and during exercise .
-OBJECTIVE	Exercise acutely decreases VLDL-TG concentration , and VLDL-TG clearance is increased after an exercise bout .
-OBJECTIVE	However , the effects of long-term training are not clear .
-METHODS	The aim was to investigate long-term effects of training by direct assessments of VLDL-TG and palmitate kinetics and oxidation in healthy lean men ( n = 9 ) at rest , before and after a 10-week training program , compared with a non-training control group ( n = 9 ) .
-METHODS	VLDL-TG kinetics were assessed by a primed constant infusion of [ 1-14C ] VLDL-TG , and VLDL-TG oxidation by specific activity ( 14CO2 ) in expired air .
-METHODS	The metabolic study days were placed 60-72h after the last exercise bout .
-RESULTS	Palmitate kinetics and oxidation were assessed by a 2h constant infusion of [ 9,10 - ( 3 ) H ] palmitate .
-RESULTS	In the training group ( n = 9 ) , maximal oxygen uptake increased significantly by 20 % ( P < 0.05 ) , and the insulin sensitivity ( assessed by the hyperinsulinemic-euglycemic clamp ) improved significantly ( P < 0.05 ) .
-RESULTS	Despite these metabolic improvements , no changes were observed in VLDL-TG secretion , clearance , or oxidation or in palmitate kinetics .
-CONCLUSIONS	We conclude that 10 weeks of exercise training did not induce changes in VLDL-TG and palmitate kinetics in healthy lean men .
-
-###25229957
-OBJECTIVE	To explore the effect of structural family therapy ( SFT ) , which refers to the application of the theory and technology of SFT for improving the internal family environment of pediatric patients through reorganization of the family roles , tasks , and boundaries , on the family structure and function in children with hematological tumors .
-METHODS	Forty children with hematological tumors were randomly divided into SFT and control groups ( n = 20 each ) .
-METHODS	The control group received conventional chemotherapy .
-METHODS	The SFT group received SFT by a trained therapist in addition to conventional chemotherapy ; the family of each patient received SFT four times ( once every two weeks ) .
-METHODS	Both groups were assessed by the Family Assessment Device ( FAD ) and Family Environment Scale-Chinese Version ( FES-CV ) on admission and one month after the end of SFT .
-RESULTS	After treatment , the SFT group showed significant decreases in all factor scores of FAD ( P < 0.05 ) ; the SFT group had significantly lower scores of problem solving , communication , roles , affective involvement , behavior control , and general functioning than the control group ( P < 0.05 ) .
-RESULTS	In addition , the SFT group had significantly increased FES-CV scores of cohesion , emotional expression , intellectual-cultural orientation , and active-recreational orientation and a significantly decreased score of conflict after treatment ( P < 0.05 ) , and the SFT group was significantly superior to the control group in terms of these items ( P < 0.05 ) .
-CONCLUSIONS	SFT could promote beneficial family changes in children with hematological tumors by improving the family function and internal environment , which would increase the long-term chemotherapy compliance of these children and their parents .
-
-###24720741
-OBJECTIVE	The aim of this study was to assess pain associated with subcutaneous injection into the abdomen and thigh of different combinations of injection speeds and volumes .
-METHODS	The study was a single-centre , one-visit , double-blinded , randomized controlled trial in 82 adults with type 1 or type 2 diabetes receiving daily injections of insulin or glucagon-like peptide-1 ( GLP-1 ) agonists .
-METHODS	Participants received 17 subcutaneous injections ( 12 in abdomen , 5 in thigh ) of saline at different injection speeds ( 150 , 300 and 450 l/s ) , with different volumes ( 400 , 800 , 1200 and 1600 l ) , and two needle insertions without any injection .
-METHODS	Pain was evaluated on a 100-mm visual analogue scale ( VAS ) ( 0 mm no pain , 100 mm worst pain ) and on a yes/no scale for pain acceptability .
-RESULTS	Injection speed had no impact on injection pain ( p = 0.833 ) .
-RESULTS	Injection of larger volumes caused significantly more pain [ VAS least square mean differences 1600 vs. 400 l , 7 2 mm ( 95 % confidence interval - CI ; 4.6-9 .7 ; p < 0.0001 ) ; 1600 vs. 800 l , 7.2 mm ( 4.4-10 .0 ; p < 0.0001 ) ; 1200 vs. 400 l , 3.5 mm ( 0.4-6 .6 ; p = 0.025 ) and 1200 vs. 800 l , 3.6 mm ( 0.4-6 .7 ; p = 0.027 ) ] .
-RESULTS	Significantly more pain occurred in the thigh versus the abdomen [ 9.0 mm ( 6.7-11 .3 ; p < 0.0001 ) ] .
-CONCLUSIONS	Injection speed had no effect on injection pain , whereas higher injection volumes caused more pain .
-CONCLUSIONS	The results of this study may be of value for guiding patients to use the appropriate injection site and technique to reduce their injection pain .
-CONCLUSIONS	Furthermore , these findings may have important implications for the development of new injection devices and drug formulations for clinical practice .
-
-###26258318
-OBJECTIVE	To compare with antibiotics with methicillin-resistant microbial coverage in a prospective fashion .
-BACKGROUND	Current antibiotic prophylaxis for vascular procedures includes a first generation cephalosporin .
-BACKGROUND	No changes in recommendations have occurred despite changes in reports of incidence of MRSA related surgical site infections .
-BACKGROUND	Does supplemental anti-MRSA prophylactic coverage provide a significant reduction in Gram-positive or MRSA infections ?
-METHODS	Single center prospective double blinded randomized study of patients undergoing lower extremity vascular procedures from 2011 to 2014 .
-METHODS	One hundred seventy-eight ( 178 ) patients were evaluated at 90 days for surgical site infection .
-METHODS	Infections were categorized as early infections less than 30 days of the index procedure and late after 90 days .
-RESULTS	Early vascular surgical site infection occurred in 7 ( 8.24 % ) of patients in the Vancomycin arm , and 11 ( 11.83 % ) in the Daptomycin arm ( P = 0.43 ) .
-RESULTS	Gram-positive related infections and MRSA infections occurred in 1 ( 1.18 % ) / 0 ( 0 % ) of Vancomycin patients and 9 ( 9.68 % ) / 1 ( 1.08 % ) of Daptomycin patients , respectively ( P < 0.02 and P = 1.00 ) .
-RESULTS	Readmissions related to surgical site infections occurred in 4 ( 4.71 % ) in the Vancomycin group and 11 ( 11.8 % ) in the Daptomycin group ( P = 0.11 ) .
-RESULTS	Patients undergoing operative exploration occurred in 5 ( 5.88 % ) in the Vancomycin group and 10 ( 10.75 % ) of the Daptomycin group ( P = 0.17 ) .
-RESULTS	Late infections were reported in 3 patients , 2 of which were in the combined Daptomycin group .
-RESULTS	Median hospital charges related to readmissions due to a surgical site infection was $ 50,823 in the combination Vancomycin arm and $ 110,920 in the combination Daptomycin group ; however , no statistical significance was appreciated ( P = 0.11 ) .
-CONCLUSIONS	Vancomycin supplemental prophylaxis seems to reduce the incidence of Gram-positive infection compared with adding supplemental Daptomycin prophylaxis .
-CONCLUSIONS	The Incidence of MRSA-related surgical site infections is low with the addition of either anti-MRSA agents compared with historical incidence of MRSA-related infection .
-
-###24758510
-BACKGROUND	The management of patients with angiographically intermediate coronary lesions is a major clinical issue .
-BACKGROUND	Fractional flow reserve provides validated functional insights while optical coherence tomography provides high resolution anatomic imaging .
-BACKGROUND	Both techniques may be applied to guide management in case of angiographically intermediate coronary lesions .
-BACKGROUND	Moreover , these techniques may be used to optimize the result of percutaneous coronary intervention .
-BACKGROUND	We aim to compare the clinical and economic impact of fractional flow reserve versus optical coherence tomography guidance in patients with angiographically intermediate coronary lesions .
-METHODS	Patients with at least one angiographically intermediate coronary lesion will be randomized ( ratio 1:1 ) to fractional flow reserve or optical coherence tomography guidance .
-METHODS	In the fractional flow reserve arm , percutaneous coronary intervention will be performed if fractional flow reserve value is 0.80 , and will be conducted with the aim of achieving a post-percutaneous coronary intervention fractional flow reserve target value of 0.90 .
-METHODS	In the optical coherence tomography arm , percutaneous coronary intervention will be performed if percentage of area stenosis ( AS % ) is 75 % or 50 to 75 % with minimal lumen area < 2.5 mm2 , or if a major plaque ulceration is detected .
-METHODS	In case of percutaneous coronary intervention , optical coherence tomography will guide the procedure in order to minimize under-expansion , malapposition , and edge dissections.Cost load and clinical outcome will be prospectively assessed at one and thirteen months .
-METHODS	The assessed clinical outcome measures will be : major cardiovascular events and occurrence of significant angina defined as a Seattle Angina Questionnaire score < 90 in the angina frequency scale .
-CONCLUSIONS	The FORZA trial will provide useful guidance for the management of patients with coronary artery disease by prospectively assessing the use of two techniques representing the gold standard for functional and anatomical definition of coronary plaques .
-BACKGROUND	Clinicaltrials.gov NCT01824030 .
-
-###25474278
-OBJECTIVE	The aim of this study was to evaluate the prognostic value of MSI-H and p53 overexpression in metastatic colorectal cancer ( mCRC ) treated with oxaliplatin and fluoropyrimidine-based first line chemotherapy .
-METHODS	Tumour samples were retrospectively obtained from 229 patients from a prospective randomised phase III trial of the AIO colorectal study group , comparing CAPOX and FUFOX in mCRC .
-METHODS	Immunohistochemistry of p53 and MMR proteins as well as microsatellite analysis were performed .
-RESULTS	The incidence of MSI-H and p53 overexpression was 7.9 % and 65.4 % , respectively .
-RESULTS	MSI-H status was not correlated with ORR , PFS and OS .
-RESULTS	We observed a trend to lower DCR for MSI-H tumours ( 65 % vs. 85 % , p = 0.055 ) .
-RESULTS	p53 overexpression was not correlated with DCR , ORR and PFS .
-RESULTS	The median OS of patients with tumors with p53 overexpression was significantly longer compared to tumors withhout p53 overexpression ( 19.6 vs. 15.8 months ; p = 0.05 ) .
-RESULTS	The post-progression survival ( PPS ) of p53-positive patients undergoing 2nd and/or 3rd line chemotherapy with irinotecan and/or cetuximab was significantly longer compared to p53-negative patients .
-CONCLUSIONS	MSI-H tumours tend to have lower disease control rates when treated with an oxaliplatin/fluoropyrmidin combination .
-CONCLUSIONS	mCRC patients with p53 overexpression undergoing an irinotecan containing second - or third-line chemotherapy after oxaliplatin failure have a significantly longer post-progression survival compared to patients without p53 overexpression .
-CONCLUSIONS	To validate the clinical impact of p53 in patients with mCRC treated with irinotecan - and/or cetuximab further studies are needed .
-
-###24629635
-BACKGROUND	New drug regimens of greater efficacy and shorter duration are needed for tuberculosis ( TB ) treatment .
-BACKGROUND	The identification of accurate , quantitative , non-culture based markers of treatment response would improve the efficiency of Phase 2 TB drug testing .
-METHODS	In an unbiased biomarker discovery approach , we applied a highly multiplexed , aptamer-based , proteomic technology to analyze serum samples collected at baseline and after 8 weeks of treatment from 39 patients with pulmonary TB from Kampala , Uganda enrolled in a Centers for Disease Control and Prevention ( CDC ) TB Trials Consortium Phase 2B treatment trial .
-RESULTS	We identified protein expression differences associated with 8-week culture status , including Coagulation Factor V , SAA , XPNPEP1 , PSME1 , IL-11 R , HSP70 , Galectin-8 , 2-Antiplasmin , ECM1 , YES , IGFBP-1 , CATZ , BGN , LYNB , and IL-7 .
-RESULTS	Markers noted to have differential changes between responders and slow-responders included nectin-like protein 2 , EphA1 ( Ephrin type-A receptor 1 ) , gp130 , CNDP1 , TGF-b RIII , MRC2 , ADAM9 , and CDON .
-RESULTS	A logistic regression model combining markers associated with 8-week culture status revealed an ROC curve with AUC = 0.96 , sensitivity = 0.95 and specificity = 0.90 .
-RESULTS	Additional markers showed differential changes between responders and slow-responders ( nectin-like protein ) , or correlated with time-to-culture-conversion ( KLRK1 ) .
-CONCLUSIONS	Serum proteins involved in the coagulation cascade , neutrophil activity , immunity , inflammation , and tissue remodeling were found to be associated with TB treatment response .
-CONCLUSIONS	A quantitative , non-culture based , five-marker signature predictive of 8-week culture status was identified in this pilot study .
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-###24481333
-OBJECTIVE	The ability of polymer-modified coils to promote stable aneurysm occlusion after endovascular treatment is not well-documented .
-OBJECTIVE	Angiographic aneurysm recurrence is widely used as a surrogate for treatment failure , but studies documenting the correlation of angiographic recurrence with clinical failure are limited .
-OBJECTIVE	This trial compares the effectiveness of Matrix ( 2 ) polyglycolic/polylactic acid biopolymer-modified coils with bare metal coils and correlates the angiographic findings with clinical failure ( ie , target aneurysm recurrence ) , a composite end point that includes any incident of posttreatment aneurysm rupture , retreatment , or unexplained death .
-METHODS	This was a multicenter randomized noninferiority trial with blinded end point adjudication .
-METHODS	We enrolled 626 patients , divided between Matrix ( 2 ) and bare metal coil groups .
-METHODS	The primary outcome was target aneurysm recurrence at 12 3 months .
-RESULTS	At 455 days , at least 1 target aneurysm recurrence event had occurred in 14.6 % of patients treated with bare metal coils and 13.3 % of Matrix ( 2 ) ( P = .76 , log-rank test ) patients ; 92.8 % of target aneurysm recurrence events were re-interventions for aneurysms that had not bled after treatment , and 5.8 % of target aneurysm recurrence events resulted from hemorrhage or rehemorrhage , with or without retreatment .
-RESULTS	Symptomatic re-intervention occurred in only 4 ( 0.6 % ) patients .
-RESULTS	At 455 days , 95.8 % of patients with unruptured aneurysms and 90.4 % of those with ruptured aneurysms were independent ( mRS 2 ) .
-RESULTS	Target aneurysm recurrence was associated with incomplete initial angiographic aneurysm obliteration , presentation with rupture , and a larger aneurysmal dome and neck size .
-CONCLUSIONS	Tested Matrix ( 2 ) coils were not inferior to bare metal coils .
-CONCLUSIONS	Endovascular coiling of intracranial aneurysms was safe , and the rate of technical success was high .
-CONCLUSIONS	Target aneurysm recurrence is a promising clinical outcome measure that correlates well with established angiographic measurements .
-
-###25140032
-BACKGROUND	Regular aerobic exercise in patients with cystic fibrosis ( CF ) improves aerobic conditioning and delays disease progression , resulting in better quality of life .
-BACKGROUND	The purpose of this study was to evaluate the effect of an aerobic exercise program based on verbal and written guidelines on maximum exercise capacity using a cardiopulmonary exercise test , quality of life , and the self-reported aerobic exercise practice of children and adolescents with CF.
-METHODS	This randomized controlled trial followed guidelines for physical exercise in a CF center .
-METHODS	Subjects were assigned to 2 groups : intervention ( group 1 ) , with 17 subjects ; and control ( group 2 ) , also with 17 subjects .
-METHODS	Data were collected from October 2010 to October 2011 , and the study population comprised 7-20-y-old children and adolescents with CF. The intervention consisted of handing out a manual with guidelines for aerobic physical exercises and reinforcing recommendations in telephone calls every 2 weeks .
-RESULTS	Thirty-four subjects were included in the study , 20 of whom were boys ( 58.5 % ) .
-RESULTS	The groups were similar at baseline .
-RESULTS	In group 1 , 6 subjects ( 35.2 % ) reported practicing physical exercises regularly .
-RESULTS	The mean age was 13.4 2.8 y , the mean percent-of-predicted FEV1 was 95.5 17.9 % , and the mean peak oxygen uptake ( VO2 ) relative to body mass was 34.9 9.0 mL/kg/min .
-RESULTS	In group 2 , 4 subjects ( 23.5 % ) reported practicing physical exercises regularly .
-RESULTS	The mean age was 12.7 3.3 y , the mean percent-of-predicted FEV1 was 100.1 21.2 % , and the mean peak VO2 was 33.2 8.2 mL/kg/min .
-RESULTS	In group 1 , there was a significant increase in physical exercise practice as reported by subjects after 3 months of intervention compared with group 2 ( P = .01 ) .
-RESULTS	No statistically significant differences were found for the other variables .
-CONCLUSIONS	Verbal and written guidelines for aerobic exercise , together with supervision over the telephone , had a positive impact on the self-reported regular physical exercise practice of children and adolescents .
-CONCLUSIONS	However , no improvement was found in lung function and maximum exercise capacity or domains of the quality of life questionnaire .
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-###25915712
-BACKGROUND	The stepped care program Bridging Intervention in Anesthesiology ( BRIA ) aims at motivating and supporting surgical patients with comorbid mental disorders to engage in psychosocial mental healthcare options .
-BACKGROUND	This study examined the efficacy of BRIA .
-METHODS	This randomized , parallel-group , open-label , controlled trial was conducted in the preoperative anesthesiological assessment clinics and surgical wards of a large university hospital in Germany .
-METHODS	A total of 220 surgical patients with comorbid mental disorders were randomized by using the computer-generated lists to one of two intervention groups : BRIA psychotherapy sessions up to 3 months postoperatively ( BRIA ) versus no psychotherapy/computerized brief written advice ( BWA ) only .
-METHODS	Primary outcome was participation in psychosocial mental healthcare options at month 6 .
-METHODS	Secondary outcome was change of self-reported general psychological distress ( Global Severity Index of the Brief Symptom Inventory ) between baseline and month 6 .
-RESULTS	At 6-month follow-up , the rate of patients who engaged in psychosocial mental healthcare options was 30 % ( 33 of 110 ) in BRIA compared with 11.8 % ( 13 of 110 ) in BWA ( P = 0.001 ) .
-RESULTS	Number needed to treat and relative risk reduction were 6 ( 95 % CI , 4 to 13 ) and 0.21 ( 0.09 to 0.31 ) , respectively .
-RESULTS	In BRIA , Global Severity Index decreased between baseline and month 6 ( P < 0.001 ) , whereas it did not change significantly in BWA ( P = 0.197 ) .
-CONCLUSIONS	Among surgical patients with comorbid mental disorders , BRIA results in an increased engagement in subsequent therapy options and a decrease of general psychological distress .
-CONCLUSIONS	These data suggest that it is reasonable to integrate innovative psychotherapy programs into the context of interdisciplinary surgical care .
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-###24812543
-OBJECTIVE	This study investigated the effects of fatty fish on sleep , daily functioning and biomarkers such as heart rate variability ( HRV ) , vitamin D status ( serum 25-hydroxyvitamin D ( 25OHD ) , and eicosapentaenoic acid ( EPA , 20:5 n-3 ) + docosahexaenoic acid ( DHA , 22:6 n-3 ) in red blood cells .
-OBJECTIVE	Moreover the relationship among sleep , daily functioning , HRV , vitamin D status , and levels of EPA+DHA was investigated .
-METHODS	Ninety-five male forensic patients from a secure forensic inpatient facility in the USA were randomly assigned into a Fish or a Control group .
-METHODS	The Fish group received Atlantic salmon three times per week from September to February , and the Control group was provided an alternative meal ( e.g. , chicken , pork , beef ) , but with the same nutritional value as their habitual diet , three times per week during the same period .
-METHODS	Sleep ( sleep latency , sleep efficiency , actual sleep time , and actual wake time ) , self-perceived sleep quality and daily functioning , as well as vitamin D status , EPA+DHA , and HRV , were assessed pre - and post-intervention period .
-RESULTS	There was a significant increase in sleep latency from pre - to post-test in the Control group .
-RESULTS	The Fish group reported better daily functioning than the Control group during post-test .
-RESULTS	Fish consumption throughout the wintertime had also an effect on resting HRV and EPA+DHA , but not on vitamin D status .
-RESULTS	However , at post-test , the vitamin D status in the Fish group was still closer to the level regarded as optimal compared to the Control group .
-RESULTS	Vitamin D status correlated negatively with actual wake time and positively with sleep efficiency during pre-test , as well as positively with daily functioning and sleep quality during post-test .
-RESULTS	Finally , HRV correlated negatively with sleep latency and positively with daily functioning .
-CONCLUSIONS	Fish consumption seemed to have a positive impact on sleep in general and also on daily functioning , which may be related to vitamin D status and HRV .
-
-###25092547
-OBJECTIVE	Neurocysticercosis ( NCC ) is a major cause of seizures and epilepsy in endemic countries .
-OBJECTIVE	Antiparasitic treatment of brain cysts leads to seizures due to the host 's inflammatory reaction , requiring concomitant steroids .
-OBJECTIVE	We hypothesized that increased steroid dosing will reduce treatment-associated seizures .
-METHODS	Open-label randomized trial comparing 6 mg/day dexamethasone for 10 days ( conventional ) with 8 mg/day for 28 days followed by a 2-week taper ( enhanced ) in patients with NCC receiving albendazole .
-METHODS	Follow-up included active seizure surveillance and brain imaging .
-METHODS	Study outcomes were seizure days and patients with seizures , both measured in days 11-42 .
-METHODS	Additional analyses compared days 1-10 , 11-21 , 22-32 , 33-42 , 43-60 , and 61-180 .
-RESULTS	Thirty-two individuals were randomized into each study arm ; two did not complete follow-up .
-RESULTS	From days 11 to 42 , 59 partial and 6 generalized seizure days occurred in 20 individuals , nonsignificantly fewer in the enhanced arm ( 12 vs. 49 , p = 0.114 ) .
-RESULTS	The numbers of patients with seizures in this period showed similar nonsignificant differences .
-RESULTS	In the enhanced steroid arm there were significantly fewer days and individuals with seizures during antiparasitic treatment ( days 1-10 : 4 vs. 17 , p = 0.004 , and 1 vs. 10 , p = 0.003 , number needed to treat [ NNT ] 4.6 , relative risk [ RR ] 0.1013 , 95 % confidence interval [ CI ] 0.01-0 .74 ) and early after dexamethasone cessation ( days 11-21 : 6 vs. 27 , p = 0.014 , and 4 vs. 12 , p = 0.021 , NNT 4.0 , RR 0.33 , 95 % CI 0.12-0 .92 ) but not after day 21 .
-RESULTS	There were no significant differences in antiparasitic efficacy or relevant adverse events .
-CONCLUSIONS	Increased dexamethasone dosing results in fewer seizures for the first 21 days during and early after antiparasitic treatment for viable parenchymal NCC but not during the first 11-42 days , which was the primary predetermined time of analysis .
-
-###24240611
-OBJECTIVE	A strategy using mechanical chest compressions might improve the poor outcome in out-of-hospital cardiac arrest , but such a strategy has not been tested in large clinical trials .
-OBJECTIVE	To determine whether administering mechanical chest compressions with defibrillation during ongoing compressions ( mechanical CPR ) , compared with manual cardiopulmonary resuscitation ( manual CPR ) , according to guidelines , would improve 4-hour survival .
-METHODS	Multicenter randomized clinical trial of 2589 patients with out-of-hospital cardiac arrest conducted between January 2008 and February 2013 in 4 Swedish , 1 British , and 1 Dutch ambulance services and their referring hospitals .
-METHODS	Duration of follow-up was 6 months .
-METHODS	Patients were randomized to receive either mechanical chest compressions ( LUCAS Chest Compression System , Physio-Control/Jolife AB ) combined with defibrillation during ongoing compressions ( n = 1300 ) or to manual CPR according to guidelines ( n = 1289 ) .
-METHODS	Four-hour survival , with secondary end points of survival up to 6 months with good neurological outcome using the Cerebral Performance Category ( CPC ) score .
-METHODS	A CPC score of 1 or 2 was classified as a good outcome .
-RESULTS	Four-hour survival was achieved in 307 patients ( 23.6 % ) with mechanical CPR and 305 ( 23.7 % ) with manual CPR ( risk difference , -0.05 % ; 95 % CI , -3.3 % to 3.2 % ; P > .99 ) .
-RESULTS	Survival with a CPC score of 1 or 2 occurred in 98 ( 7.5 % ) vs 82 ( 6.4 % ) ( risk difference , 1.18 % ; 95 % CI , -0.78 % to 3.1 % ) at intensive care unit discharge , in 108 ( 8.3 % ) vs 100 ( 7.8 % ) ( risk difference , 0.55 % ; 95 % CI , -1.5 % to 2.6 % ) at hospital discharge , in 105 ( 8.1 % ) vs 94 ( 7.3 % ) ( risk difference , 0.78 % ; 95 % CI , -1.3 % to 2.8 % ) at 1 month , and in 110 ( 8.5 % ) vs 98 ( 7.6 % ) ( risk difference , 0.86 % ; 95 % CI , -1.2 % to 3.0 % ) at 6 months with mechanical CPR and manual CPR , respectively .
-RESULTS	Among patients surviving at 6 months , 99 % in the mechanical CPR group and 94 % in the manual CPR group had CPC scores of 1 or 2 .
-CONCLUSIONS	Among adults with out-of-hospital cardiac arrest , there was no significant difference in 4-hour survival between patients treated with the mechanical CPR algorithm or those treated with guideline-adherent manual CPR .
-CONCLUSIONS	The vast majority of survivors in both groups had good neurological outcomes by 6 months .
-CONCLUSIONS	In clinical practice , mechanical CPR using the presented algorithm did not result in improved effectiveness compared with manual CPR .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00609778 .
-
-###25237116
-BACKGROUND	Parkinson 's disease ( PD ) has a progressive course and is characterized by the degeneration of dopaminergic neurons .
-BACKGROUND	Although no neuroprotective treatments for PD have been found to date , the endocannabinoid system has emerged as a promising target .
-METHODS	From a sample of 119 patients consecutively evaluated in a specialized movement disorders outpatient clinic , we selected 21 PD patients without dementia or comorbid psychiatric conditions .
-METHODS	Participants were assigned to three groups of seven subjects each who were treated with placebo , cannabidiol ( CBD ) 75 mg/day or CBD 300 mg/day .
-METHODS	One week before the trial and in the last week of treatment participants were assessed in respect to ( i ) motor and general symptoms score ( UPDRS ) ; ( ii ) well-being and quality of life ( PDQ-39 ) ; and ( iii ) possible neuroprotective effects ( BDNF and H ( 1 ) - MRS ) .
-RESULTS	We found no statistically significant differences in UPDRS scores , plasma BDNF levels or H ( 1 ) - MRS measures .
-RESULTS	However , the groups treated with placebo and CBD 300 mg/day had significantly different mean total scores in the PDQ-39 ( p = 0.05 ) .
-CONCLUSIONS	Our findings point to a possible effect of CBD in improving quality of life measures in PD patients with no psychiatric comorbidities ; however , studies with larger samples and specific objectives are required before definitive conclusions can be drawn .
-
-###24273298
-BACKGROUND	Gait training for patients with hemiparesis is carried out independently overground or on a treadmill .
-BACKGROUND	Several studies have shown differences in hemiparetic gait parameters during overground versus treadmill walking .
-BACKGROUND	However , few studies have compared the effects of these 2 gait training conditions on gait parameters , and no study has compared the short-term effects of these techniques on all biomechanical gait parameters .
-OBJECTIVE	To determine whether a gait training session performed overground or on a treadmill induces specific short-term effects on biomechanical gait parameters in patients with hemiparesis .
-METHODS	Twenty-six subjects with hemiparesis were randomly assigned to a single session of either overground or treadmill gait training .
-METHODS	The short-term effects on spatiotemporal , kinematic , and kinetic gait parameters were assessed using gait analysis before and immediately after the training and after a 20-minute rest .
-RESULTS	Speed , cadence , percentage of single support phase , peak knee extension , peak propulsion , and braking on the paretic side were significantly increased after the gait training session .
-RESULTS	However , there were no specific changes dependent on the type of gait training performed ( overground or on a treadmill ) .
-CONCLUSIONS	A gait training session performed by subjects with hemiparesis overground or on a treadmill did not induce specific short-term effects on biomechanical gait parameters .
-CONCLUSIONS	The increase in gait velocity that followed a gait training session seemed to reflect specific modifications of the paretic lower limb and adaptation of the nonparetic lower limb .
-
-###25062861
-BACKGROUND	Virtual visits through web-based video conferencing can increase access to specialty care for individuals with Huntington disease ( HD ) and facilitate research participation .
-OBJECTIVE	To determine the feasibility of conducting virtual visits directly into the homes of individuals with HD , to assess the reliability of conducting remote versus in-person motor assessments , and to determine the test-retest reliability of conducting motor assessments remotely .
-METHODS	Individuals with mild to moderate HD underwent baseline in-person clinic assessments and completed a HD care survey .
-METHODS	Participants were randomized to receive three virtual visits from one of two physicians over four months that included a modified Unified Huntington 's Disease Rating Scale motor examination ( excluding rigidity and balance assessments ) via web-based video conferencing .
-METHODS	Intraclass coefficients ( ICC ) were calculated to determine the level of agreement between remote and in-person assessments .
-METHODS	Participants also completed a survey on their interest in telemedicine .
-RESULTS	Thirteen individuals underwent baseline assessments , eleven ( 85 % ) participants completed at least one virtual visit , and 27 ( 82 % ) of 33 total virtual visits were completed .
-RESULTS	Remote motor scores demonstrated good reliability ( ICC = 0.78 ; n = 11 ) compared to in-person motor scores .
-RESULTS	Test-retest reliability of motor scores conducted remotely was excellent ( ICC = 0.90 ; n = 11 ) .
-RESULTS	Participants expressed moderate future interest in using virtual visits to participate in research and to receive care .
-CONCLUSIONS	In this pilot study , virtual visits into the home were feasible and reliable for conducting motor assessments in HD .
-CONCLUSIONS	Larger scale studies need to confirm and generalize these findings to a broader population of participants .
-
-###24962503
-OBJECTIVE	To improve adolescent notification of positive sexually transmitted infection ( STI ) tests using mobile phone technology and STI information cards .
-METHODS	A randomized intervention among 14 - to 21-year olds in a pediatric emergency department ( PED ) .
-METHODS	A 2 3 factorial design with replication was used to evaluate the effectiveness of six combinations of two factors on the proportion of STI-positive adolescents notified within 7days of testing .
-METHODS	Independent factors included method of notification ( call , text message , or call + text message ) and provision of an STI information card with or without a phone number to obtain results .
-METHODS	Covariates for logistic regression included age , empiric STI treatment , days until first attempted notification , and documentation of confidential phone number .
-RESULTS	Approximately half of the 383 females and 201 males enrolled were 18years of age .
-RESULTS	Texting only or type of card was not significantly associated with patient notification rates , and there was no significant interaction between card and notification method .
-RESULTS	For females , successful notification was significantly greater for call + text message ( odds ratio , 3.2 ; 95 % confidence interval , 1.4-6 .9 ) , and documenting a confidential phone number was independently associated with successful notification ( odds ratio , 3.6 ; 95 % confidence interval , 1.7-7 .5 ) .
-RESULTS	We found no significant predictors of successful notification for males .
-RESULTS	Of patients with a documented confidential phone number who received a call + text message , 94 % of females and 83 % of males were successfully notified .
-CONCLUSIONS	Obtaining a confidential phone number and using call + text message improved STI notification rates among female but not male adolescents in a pediatric emergency department .
-
-###24379072
-OBJECTIVE	To investigate biochemically whether total intravenous anesthesia ( TIVA ) using propofol creates a risk for Propofol Infusion Syndrome ( PRIS ) .
-METHODS	Forty patients scheduled for thyroid gland surgery were randomly assigned into Group T or C and premedicated 30 min before operation .
-METHODS	Group T received remifentanyl hydrochloride , propofol infusion following anesthesia induction with propofol , vecuronium bromide and intubation .
-METHODS	Group C received remifentanyl hydrochloride infusion , 1-1 .5 MAC desflurane inhalation following anesthesia induction with thiopental , vecuronium bromide and intubation .
-METHODS	Patients were respired 50 % O2-air mixture .
-METHODS	Blood gas , potassium , lactic acid , CK-MB , myoglobin , troponin I , total carnitine , triglyceride , creatinine concentrations were determined before operation , at intraoperative hour-2 , postoperative hour-6 .
-RESULTS	There were no significant differences between groups in potassium , lactic acid CK-MB , myoglobin , total carnitine or creatinine levels .
-RESULTS	Triglyceride level at intraoperative hour-2 increased in Group T , decreased at postoperative hour-6 .
-RESULTS	Troponin I was higher in Group C than Group T at intraoperative hour-2 ( p < 0.05 ) .
-RESULTS	No asystole , bradycardia , arrhythmia , hypotension or change in urine color was detected .
-CONCLUSIONS	The present biochemical findings suggest that TIVA using propofol is safe .
-
-###25687878
-OBJECTIVE	Traditional rotation-based models of placebo nausea are limited because they do not have vehicle settings and are tied to their context .
-OBJECTIVE	The present study introduces a new model for examining placebo-induced nausea in the laboratory that overcomes these limitations , namely , Galvanic Vestibular Stimulation ( GVS ) .
-OBJECTIVE	GVS stimulates the vestibular system to cause nausea through sensory mismatch with visual cues and importantly has a non-nauseating placebo setting .
-OBJECTIVE	Using this , we tested whether conditioning could elicit placebo nausea when participants were later exposed to placebo stimulation as well as whether this placebo nausea was generalised across contexts -- something that is extremely difficult to test with rotation-based models of placebo nausea .
-METHODS	Thirty healthy undergraduate students were randomised to receive either placebo GVS ( controls ) or active GVS during training ( Context-Consistent and Context-Change ) .
-METHODS	On test , all groups received placebo GVS .
-METHODS	The controls and Context-Consistent groups were tested in the same context as training , whereas the Context-Change group was tested in a new context .
-RESULTS	Participants conditioned with nausea during training had significantly higher nausea symptom ratings after placebo stimulation on test than those given no conditioning .
-RESULTS	This placebo-induced nausea also generalised to a novel test context with no differences observed between the Context-Change and Context-Consistent groups .
-CONCLUSIONS	GVS provides a new model of placebo-induced nausea that overcomes limitations to traditional rotation-based paradigms .
-CONCLUSIONS	Future studies should use this device to explore the effect of instructions and conditioning on the development of placebo nausea and to assess the efficacy of conditioning-based interventions for clinical use .
-
-###24529654
-BACKGROUND	Contrasting results have been reported regarding the influence of the use of adhesive on biofilm formation .
-OBJECTIVE	The purpose of this study was to evaluate the influence of the use of adhesive on the formation of biofilm on the internal surface of complete dentures and the palatal mucosa of denture wearers .
-METHODS	Thirty participants with well-fitting complete dentures were randomly divided according to the experimental design : protocol 1 , adhesive use during the first 15 days , followed by no use of adhesive over the next 15 days ; protocol 2 , no use of adhesives during the first 15 days , followed by adhesive use over the next 15 days .
-METHODS	After each period , material from the mucosa and intaglio of the maxillary dentures was collected .
-METHODS	Replicate aliquots were plated onto Petri dishes containing selective media for Candida spp , Streptococcus mutans , and a nonselective culture medium .
-METHODS	Colony-forming units were expressed as log ( CFU +1 ) / mL .
-METHODS	In addition , the internal surfaces of the maxillary and mandibular complete dentures were stained and photographed .
-METHODS	From the photographs , the total internal surface and the surface stained with biofilm were quantified ( software ImageTool 3.00 ) , and the percentage of the biofilm-covered area ( % ) on the maxillary and mandibular dentures was calculated and compared with 2-way ANOVA .
-METHODS	For the nonselective culture medium , data were compared with the paired-sample t test , and the Wilcoxon signed rank test was performed to compare the colony counts of Candida spp and Streptococcus mutans ( = .05 ) .
-RESULTS	Similar colony counts were found with or without the use of adhesive for the mucosa and internal surfaces of maxillary dentures , irrespective of the culture medium ( P > .05 ) .
-RESULTS	The area of dentures covered with biofilm was influenced by the use of adhesive ( P = .025 ) , regardless of the type of denture ( P = .121 ) .
-CONCLUSIONS	The use of adhesive did not alter the colony counts of microorganisms from the palatal mucosa and maxillary dentures of complete denture wearers during the 15-day period , but it did influence the area covered with biofilm on the internal surfaces of the complete dentures .
-
-###24645966
-OBJECTIVE	To compare the efficacy and tolerability of a low-volume ( 2-L ) polyethylene glycol ( PEG ) regimen for colonoscopy compared to single ( 4-L ) or split-dose ( 2-L +2 - L ) regimens .
-METHODS	In-hospital patients who were candidates for colonoscopy were randomly assigned to : group 1 single-dose ( PEG 4L the day before the study , n = 60 ) ; group 2 : split-dose ( 2L the day before and 2L on the day of the procedure , n = 61 ) ; and group 3 : low-volume 2-L PEG solution ( the day of the procedure , n = 59 ) .
-METHODS	A blinded evaluation of the quality of colonic preparation was assessed by the Boston bowel preparation scale .
-RESULTS	Satisfactory bowel preparation of the right colon was more frequently reported for group 3 than for group 1 ( 70 % vs 53 % , P = 0.045 ) , in the transverse colon it was 82 % versus 69 % ( P = 0.032 ) , and on the left side of the colon it was 80 % versus 67.7 % ( P = 0.028 ) .
-RESULTS	Compared to group 2 , satisfactory bowel preparation in group 3 was similar in the transverse colon and left colon .
-RESULTS	Nausea , vomiting , and abdominal discomfort were less frequent in patients of group 3 .
-RESULTS	Patients in group 3 had fewer sleep disorders and fewer hours of sleep loss compared to patients in the other groups .
-CONCLUSIONS	Preparation with 2L caused less abdominal discomfort and fewer sleep disorders .
-CONCLUSIONS	The split dose had a better quality of preparation in the right colon .
-CONCLUSIONS	Both preparations were clearly better than the 4-L preparation .
-
-###24861837
-BACKGROUND	Traditional Chinese medicine ( TCM ) is considered an important complementary therapy with beneficial effects for cancer patients .
-BACKGROUND	Elderly patients with non-small-cell lung cancer ( NSCLC ) are a complex patient group with increasing co-morbidity and shrinking physiological reserve , and may derive substantial benefit from the supportive aspects of TCM .
-BACKGROUND	Researchers from Shanghai Longhua Hospital found that qi and yin deficiency is a common syndrome in patients with stage III or IV lung cancer .
-BACKGROUND	This project was designed to study the combination of single-agent chemotherapy with TCM methods of benefiting qi and yin in elderly patients with advanced NSCLC .
-METHODS	This is a double-blind controlled , multi-center , and prospective study with randomly selected participants from elderly NSCLC patients in China .
-METHODS	Seventy-six patients who meet the inclusion criteria will be allocated into two groups , which will receive treatments of 3-week single-agent chemotherapy with TCM or placebo for four cycles .
-METHODS	Progression-free survival ( PFS ) is the primary end point , and the secondary end points are overall survival , objective response rate , time-to-progression , and quality of life ( EORTC QLQ-LC43 , and TCM syndrome score ) .
-METHODS	Meanwhile , other end points such as toxicity , side effects and safety of the treatments will be assessed .
-CONCLUSIONS	Results from this study may provide evidence on the effectiveness , and parameters for the usage of single-agent chemotherapy combined with or without TCM on PFS of elderly patients with NSCLC .
-BACKGROUND	ClinicalTrials.gov .
-BACKGROUND	( Identifier : NCT01780181 ) .
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-###25592987
-BACKGROUND	Coadministration of a bacterial adjuvant with oral immunotherapy ( OIT ) has been suggested as a potential treatment for food allergy .
-OBJECTIVE	To evaluate a combined therapy comprising a probiotic together with peanut OIT .
-METHODS	We performed a double-blind , placebo-controlled randomized trial of the probiotic Lactobacillus rhamnosus CGMCC 1.3724 and peanut OIT ( probiotic and peanut oral immunotherapy [ PPOIT ] ) in children ( 1-10 years ) with peanut allergy .
-METHODS	The primary outcome was induction of sustained unresponsiveness 2 to 5 weeks after discontinuation of treatment ( referred to as possible sustained unresponsiveness ) .
-METHODS	Secondary outcomes were desensitization , peanut skin prick test , and specific IgE and specific IgG4 measurements .
-RESULTS	Sixty-two children were randomized and stratified by age ( 5 and > 5 years ) and peanut skin test wheal size ( 10 and > 10 mm ) ; 56 reached the trial 's end .
-RESULTS	Baseline demographics were similar across groups .
-RESULTS	Possible sustained unresponsiveness was achieved in 82.1 % receiving PPOIT and 3.6 % receiving placebo ( P < .001 ) .
-RESULTS	Nine children need to be treated for 7 to achieve sustained unresponsiveness ( number needed to treat , 1.27 ; 95 % CI , 1.06-1 .59 ) .
-RESULTS	Of the subjects , 89.7 % receiving PPOIT and 7.1 % receiving placebo were desensitized ( P < .001 ) .
-RESULTS	PPOIT was associated with reduced peanut skin prick test responses and peanut-specific IgE levels and increased peanut-specific IgG4 levels ( all P < .001 ) .
-RESULTS	PPOIT-treated participants reported a greater number of adverse events , mostly with maintenance home dosing .
-CONCLUSIONS	This is the first randomized placebo-controlled trial evaluating the novel coadministration of a probiotic and peanut OIT and assessing sustained unresponsiveness in children with peanut allergy .
-CONCLUSIONS	PPOIT was effective in inducing possible sustained unresponsiveness and immune changes that suggest modulation of the peanut-specific immune response .
-CONCLUSIONS	Further work is required to confirm sustained unresponsiveness after a longer period of secondary peanut elimination and to clarify the relative contributions of probiotics versus OIT .
-
-###24331381
-BACKGROUND	Atopic dermatitis ( AD ) is a common inflammatory skin disease with a global prevalence ranging from 3 % to 20 % .
-BACKGROUND	Patients with AD have an increased risk for complications after viral infection ( eg , herpes simplex virus ) , and vaccination of patients with AD with live vaccinia virus is contraindicated because of a heightened risk of eczema vaccinatum , a rare but potentially lethal complication associated with smallpox vaccination .
-OBJECTIVE	We sought to develop a better understanding of immunity to cutaneous viral infection in patients with AD .
-METHODS	In a double-blind randomized study we investigated the safety and immunogenicity of live attenuated yellow fever virus ( YFV ) vaccination of nonatopic subjects and patients with AD after standard subcutaneous inoculation or transcutaneous vaccination administered with a bifurcated needle .
-METHODS	Viremia , neutralizing antibody , and antiviral T-cell responses were analyzed for up to 30 days after vaccination .
-RESULTS	YFV vaccination administered through either route was well tolerated .
-RESULTS	Subcutaneous vaccination resulted in higher seroconversion rates than transcutaneous vaccination but elicited similar antiviral antibody levels and T-cell responses in both the nonatopic and AD groups .
-RESULTS	After transcutaneous vaccination , both groups mounted similar neutralizing antibody responses , but patients with AD demonstrated lower antiviral T-cell responses by 30 days after vaccination .
-RESULTS	Among transcutaneously vaccinated subjects , a significant inverse correlation between baseline IgE levels and the magnitude of antiviral antibody and CD4 ( + ) T-cell responses was observed .
-CONCLUSIONS	YFV vaccination of patients with AD through the transcutaneous route revealed that high baseline IgE levels provide a potential biomarker for predicting reduced virus-specific immune memory after transcutaneous infection with a live virus .
-
-###25807399
-BACKGROUND	Optimal resuscitation of hypotensive trauma patients has not been defined .
-BACKGROUND	This trial was performed to assess the feasibility and safety of controlled resuscitation ( CR ) versus standard resuscitation ( SR ) in hypotensive trauma patients .
-METHODS	Patients were enrolled and randomized in the out-of-hospital setting .
-METHODS	Nineteen emergency medical services ( EMS ) systems in the Resuscitation Outcome Consortium participated .
-METHODS	Eligible patients had an out-of-hospital systolic blood pressure ( SBP ) of 90 mm Hg or lower .
-METHODS	CR patients received 250 mL of fluid if they had no radial pulse or an SBP lower than 70 mm Hg and additional 250-mL boluses to maintain a radial pulse or an SBP of 70 mm Hg or greater .
-METHODS	The SR group patients received 2 L initially and additional fluid as needed to maintain an SBP of 110 mm Hg or greater .
-METHODS	The crystalloid protocol was maintained until hemorrhage control or 2 hours after hospital arrival .
-RESULTS	A total of 192 patients were randomized ( 97 CR and 95 SR ) .
-RESULTS	The CR and SR groups were similar at baseline .
-RESULTS	The mean ( SD ) crystalloid volume administered during the study period was 1.0 L ( 1.5 ) in the CR group and 2.0 L ( 1.4 ) in the SR group , a difference of 1.0 L ( 95 % confidence interval [ CI ] , 0.6-1 .4 ) .
-RESULTS	Intensive care unit-free days , ventilator-free days , renal injury , and renal failure did not differ between the groups .
-RESULTS	At 24 hours after admission , there were 5 deaths ( 5 % ) in the CR group and 14 ( 15 % ) in the SR group ( adjusted odds ratio , 0.39 ; 95 % CI , 0.12-1 .26 ) .
-RESULTS	Among patients with blunt trauma , 24-hour mortality was 3 % ( CR ) and 18 % ( SR ) with an adjusted odds ratio of 0.17 ( 0.03-0 .92 ) .
-RESULTS	There was no difference among patients with penetrating trauma ( 9 % vs. 9 % ; adjusted odds ratio , 1.93 ; 95 % CI , 0.19-19 .17 ) .
-CONCLUSIONS	CR is achievable in out-of-hospital and hospital settings and may offer an early survival advantage in blunt trauma .
-CONCLUSIONS	A large-scale , Phase III trial to examine its effects on survival and other clinical outcomes is warranted .
-METHODS	Therapeutic study , level I.
-
-###25256183
-OBJECTIVE	Early and intensive blood pressure-lowering treatment seems to be beneficial in patients with acute hemorrhagic stroke and high blood pressure .
-OBJECTIVE	We wanted to see if similar benefits can be shown from a later and more gradual blood pressure lowering , using data from the Scandinavian Candesartan Acute Stroke Trial ( SCAST ) .
-METHODS	SCAST was a randomized - and placebo-controlled , double-masked trial of candesartan given for 7 days , in 2029 patients with acute stroke and systolic blood pressure 140 mm Hg .
-METHODS	We assessed the effects of candesartan in the 274 patients with hemorrhagic stroke , using the trial 's 2 coprimary effect variables : the composite vascular end point of vascular death , stroke or myocardial infarction , and functional outcome at 6 months , according to the modified Rankin Scale .
-METHODS	We used Cox proportional hazards models and ordinal regression for analysis and adjusted for key , predefined prognostic variables .
-RESULTS	There was no association between treatment with candesartan and risk of vascular events ( 17 of 144 [ 11.8 % ] versus 13 of 130 [ 10.0 % ] ; hazard ratio , 1.36 ; 95 % confidence interval , 0.65-2 .83 ; P = 0.41 ) .
-RESULTS	For functional outcome we found evidence of a negative effect of candesartan ( common odds ratio , 1.61 ; 95 % confidence interval , 1.03-2 .50 ; P = 0.036 ) .
-CONCLUSIONS	There was no evidence that blood pressure-lowering treatment with candesartan is beneficial during the first week of hemorrhagic stroke .
-CONCLUSIONS	Instead , there were signs that such treatment may be harmful , but this needs to be verified in larger studies .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00120003 .
-
-###25449513
-BACKGROUND	The prognostic significance of long-term visit-to-visit blood pressure variability ( BPV ) has not yet been validated in `` real world '' hypertensive patients .
-BACKGROUND	The aim of the current study is to explore the prognostic value of BPV on stroke in hypertensive patients .
-METHODS	This was a dynamic prospective cohort study based on electronic medical records in Shanghai , China .
-METHODS	Hypertensive patients ( N = 122,636 ) without history of stroke at baseline , were followed up from 2005 to 2011 .
-METHODS	The cohort comprised of 4522 stroke patients and 118,114 non-stroke patients during a mean follow-up duration of 48 months .
-METHODS	BPV was measured by standard deviation ( SD ) and the coefficient of variation ( CV ) of blood pressure .
-RESULTS	The visit-to-visit variability of both systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) was independently associated with the occurrence of stroke [ SD : the hazard ratios ( 95 % confidence intervals ) of SBP and DBP were 1.042 ( 1.021 to 1.064 ) and 1.052 ( 1.040 to 1.065 ) ; CV : the hazard ratios ( 95 % confidence intervals ) of SBP and DBP were 1.183 ( 1.010 to 1.356 ) and 1.151 ( 1.005 to 1.317 ) , respectively ] .
-RESULTS	The hazard ratio values increased along with an increase of the BPV levels of SBP and DBP .
-RESULTS	The increment effect remained significant after controlling the blood pressure control status of subjects .
-CONCLUSIONS	Increased BPV of both SBP and DBP , independent of the average blood pressure , is a predictor of stroke among community hypertensive patients in real-world clinical practice .
-CONCLUSIONS	The risk of stroke increased along with increased BPV .
-CONCLUSIONS	Stabilizing BPV might be a therapeutic target in hypertension .
-
-###25271779
-OBJECTIVE	Trichotillomania is a psychiatric condition characterized by the chronic pulling and plucking of one 's own hair .
-OBJECTIVE	Cognitive-behavioral therapy shows promise as a treatment for trichotillomania and might be preferable to pharmacotherapy .
-OBJECTIVE	However , there have been no randomized , controlled studies of the efficacy of group cognitive-behavioral therapy .
-METHODS	We evaluated 44 subjects , recruited from April 2009 to May 2010 , all of whom met DSM-IV criteria for a diagnosis of trichotillomania .
-METHODS	Subjects were randomized to receive 22 sessions of either group cognitive-behavioral therapy or group supportive therapy ( control ) .
-METHODS	Treatment evaluation was non-blind and used self-report scales .
-METHODS	The primary outcome measure was the improvement of hair-plucking behavior as assessed by the Massachusetts General Hospital Hairpulling Scale .
-METHODS	Secondary measures included scores on the Beck Depression Inventory , the Beck Anxiety Inventory , and the Social Adjustment Scale-Self-Report .
-RESULTS	Both groups showed significant posttreatment improvement in the scores from the Massachusetts General Hospital Hairpulling Scale ( F = 23.762 , P < .001 ) and the Beck Depression Inventory ( F = 6.579 , P = .003 ) .
-RESULTS	The decrease in hair-plucking behavior over time was significantly greater in the study group than in the control group ( F = 3.545 , P < .038 ) .
-RESULTS	There were no significant differences between the pretreatment and posttreatment time points or between the groups in the scores from the Beck Anxiety Inventory and the Social Adjustment Scale-Self-Report .
-CONCLUSIONS	We conclude that group cognitive-behavioral therapy is a valid treatment for trichotillomania .
-CONCLUSIONS	This treatment model should be further revised and expanded to address comorbidities such as anxiety and social maladjustment .
-BACKGROUND	ClinicalTrials.gov identifier : NCT01968343 .
-
-###25668198
-BACKGROUND	Longitudinal data on bone mineral density ( BMD ) in children and adolescents with Prader-Willi Syndrome ( PWS ) during long-term GH treatment are not available .
-OBJECTIVE	This study aimed to determine effects of long-term GH treatment and puberty on BMD of total body ( BMDTB ) , lumbar spine ( BMDLS ) , and bone mineral apparent density of the lumbar spine ( BMADLS ) in children with PWS .
-METHODS	This was a prospective longitudinal study of a Dutch PWS cohort .
-METHODS	Seventy-seven children with PWS who remained prepubertal during GH treatment for 4 years and 64 children with PWS who received GH treatment for 9 years participated in the study .
-METHODS	The children received GH treatment , 1 mg/m ( 2 ) / day ( 0.035 mg/kg/d ) .
-METHODS	BMDTB , BMDLS , and BMADLS was measured by using the same dual-energy x-ray absorptiometry machine for all annual measurements .
-RESULTS	In the prepubertal group , BMDTB standard deviation score ( SDS ) and BMDLSSDS significantly increased during 4 years of GH treatment whereas BMADLSSDS remained stable .
-RESULTS	During adolescence , BMDTBSDS and BMADLSSDS decreased significantly , in girls from the age of 11 years and in boys from the ages of 14 and 16 years , respectively , but all BMD parameters remained within the normal range .
-RESULTS	Higher Tanner stages tended to be associated with lower BMDTBSDS ( P = .083 ) and a significantly lower BMADLSSDS ( P = .016 ) .
-RESULTS	After 9 years of GH treatment , lean body mass SDS was the most powerful predictor of BMDTBSDS and BMDLSSDS in adolescents with PWS .
-CONCLUSIONS	This long-term GH study demonstrates that BMDTB , BMDLS , and BMADLS remain stable in prepubertal children with PWS but decreases during adolescence , parallel to incomplete pubertal development .
-CONCLUSIONS	Based on our findings , clinicians should start sex hormone therapy from the age of 11 years in girls and 14 years in boys unless there is a normal progression of puberty .
-
-###24676798
-OBJECTIVE	To examine disordered eating and associations with health-related quality of life ( HRQOL ) in rural overweight/obese ( OW/OB ) children .
-METHODS	Cross-sectional analyses were conducted with 272 rural OW/OB children aged 8-12 years ( M = 10.36 ; SD = 1.39 ) .
-METHODS	Child anthropometrics , demographics , disordered eating attitudes , unhealthy weight control behaviors ( UWCBs ) , and HRQOL were measured .
-METHODS	Relationships between these variables were analyzed using bootstrapped multiple linear regressions .
-RESULTS	Clinically significant disordered eating attitudes were endorsed by 17 % of the sample , and the majority endorsed UWCBs .
-RESULTS	Disordered eating attitudes and weight status were the most common predictors of HRQOL .
-RESULTS	Disordered eating attitudes and UWCBs were negatively related to emotional HRQOL but were unrelated to social , school , or physical HRQOL .
-CONCLUSIONS	Disordered eating is a serious and relevant problem in OW/OB children living in rural areas and may be indicative of impairments in emotional functioning .
-CONCLUSIONS	Early intervention may reduce the risk for eating disorders and associated negative sequelae .
-
-###24344215
-OBJECTIVE	From 2002 to 2007 , the International Berlin-Frankfurt-Mnster Study Group conducted a prospective randomized clinical trial ( ALL IC-BFM 2002 ) for the management of childhood acute lymphoblastic leukemia ( ALL ) in 15 countries on three continents .
-OBJECTIVE	The aim of this trial was to explore the impact of differential delayed intensification ( DI ) on outcome in all risk groups .
-METHODS	For this trial , 5,060 eligible patients were divided into three risk groups according to age , WBC , early treatment response , and unfavorable genetic aberrations .
-METHODS	DI was randomized as follows : standard risk ( SR ) , two 4-week intensive elements ( protocol III ) versus one 7-week protocol II ; intermediate risk ( IR ) , protocol III 3 versus protocol II 1 ; high risk ( HR ) , protocol III 3 versus either protocol II 2 ( Associazione Italiana Ematologia Oncologia Pediatrica [ AIEOP ] option ) , or 3 HR blocks plus single protocol II ( Berlin-Frankfurt-Mnster [ BFM ] option ) .
-RESULTS	At 5 years , the probabilities of event-free survival and survival were 74 % ( 1 % ) and 82 % ( 1 % ) for all 5,060 eligible patients , 81 % and 90 % for the SR ( n = 1,564 ) , 75 % and 83 % for the IR ( n = 2,650 ) , and 55 % and 62 % for the HR ( n = 846 ) groups , respectively .
-RESULTS	No improvement was accomplished by more intense and/or prolonged DI .
-CONCLUSIONS	The ALL IC-BFM 2002 trial is a good example of international collaboration in pediatric oncology .
-CONCLUSIONS	A wide platform of countries able to run randomized studies in ALL has been established .
-CONCLUSIONS	Although the alternative DI did not improve outcome compared with standard treatment and the overall results are worse than those achieved by longer established leukemia groups , the national results have generally improved .
-
-###26437532
-OBJECTIVE	To evaluate the efficacy and safety of azithromycinfor treatment of uncomplicated pediatric scrub typhus .
-METHODS	A randomized controlled trial was performed .
-METHODS	We compared azithromycin with doxycycline or chloramphenicol in uncomplicated pediatric scrub typhus from inpatient pediatric department of Chiangrai Prachanukroh Hospital .
-METHODS	The primary outcome was cure rate at day 3 .
-METHODS	The secondary outcomes were timing to defervescence within 72 hours , side effects , and relapsed rate .
-METHODS	We compared data between both groups with Fisher 's exact test or Mann-Whitney U test , and failure rate was demonstrated by Kaplan-Meier survival curve and Log-rank test .
-RESULTS	We included 57 patients , ofwhom , 28 were assigned to doxycycline or chloramphenicol ( control group ) and 29 to azithromycin ( study group ) .
-RESULTS	The baseline characteristics of both groups were similar The cure rate was 85.7 % in the doxycycline or chloramphenicol group , as compared to 79.3 % in the azithromycin group ( p = 0.73 ) , and a median time to defervescence was 30 hours ( IQR 21 , 48 ) vs. 36 hours ( IQR 20 , 68 ) respectively ( p = 0.166 ) .
-RESULTS	There was a little minor side effect in azithromycin group .
-RESULTS	No relapsed was found in either groups .
-CONCLUSIONS	Azithromycin was as effective as doxycycline or chloramphenicol in treatment of uncomplicated pediatric scrub typhus .
-
-###24509504
-BACKGROUND	Obesity in youth remains a major public health issue .
-BACKGROUND	Yet no effective long-term preventive strategy exists .
-BACKGROUND	We previously showed that a school-based socio-ecological approach targeting behavior and social/environmental influences on physical activity ( PA ) prevented 4-year excessive weight gain in 12-year olds .
-BACKGROUND	In this study , we investigated if this efficacy persists 30 months after intervention cessation .
-RESULTS	The program targeted students , family , school and the living environment to promote/support PA and prevent sedentary behavior ( SB ) .
-RESULTS	A total of 732 students from eight randomized middle schools completed the 4-year trial .
-RESULTS	At the 30-month post-trial follow-up , body mass index ( BMI ) , fat mass index ( FMI ) , leisure PA ( LPA ) , home/school/workplace active commuting , TV/video time ( TVT ) , and attitudes toward PA were measured in 531 adolescents .
-RESULTS	The beneficial effects of the intervention on the excess BMI increase ( +0.01 vs +0.34 kgm ( -2 ) in the intervention and control groups , respectively ) and on the overweight incidence in initially non-overweight students ( 4.3 % vs 8.6 % ; odds ratio = 0.48 ( 95 % confidence interval : 0.23-1 .01 ) ) were maintained at the post-trial follow-up .
-RESULTS	LPA was not maintained at the level achieved during the trial .
-RESULTS	However , we still observed a prevention of the age-related decrease of the adolescents ' percentage reporting regular LPA ( -14.4 % vs -26.5 % ) and a higher intention to exercise in the intervention group .
-RESULTS	The intervention promoted lower TVT ( -14.0 vs +13.6 min per day ) and higher active commuting changes ( +11.7 % vs -4.8 % ) .
-RESULTS	Trends in higher BMI reduction in students with high initial TVT and in the least wealthy group were noted .
-RESULTS	TVT changes throughout the follow-up predicted excess BMI and FMI changes .
-CONCLUSIONS	Long-term multilevel approach targeting PA and SB prevents excessive weight gain up to 30 months after intervention cessation .
-CONCLUSIONS	The efficacy may be higher in the most sedentary and least wealthy adolescents .
-CONCLUSIONS	Healthy PA-related behavior inducing long-lasting weight effects can be promoted in youth providing that an ecological approach is introduced in the prevention strategy .
-
-###24843066
-BACKGROUND	Adolescents with chronic disease ( ACD ) must develop independent disease self-management and learn to communicate effectively with their health care team to transition from pediatric to adult-oriented health care systems .
-BACKGROUND	Disease-specific interventions have been implemented to aid specific ACD groups through transition .
-BACKGROUND	A generic approach might be effective and cost-saving .
-METHODS	Eighty-one ACD , aged 12 to 20 years , were recruited for a randomized clinical trial evaluating an 8-month transition intervention ( MD2Me ) .
-METHODS	MD2Me recipients received a 2-month intensive Web-based and text-delivered disease management and skill-based intervention followed by a 6-month review period .
-METHODS	MD2Me recipients also had access to a texting algorithm for disease assessment and health care team contact .
-METHODS	The intervention was applicable to adolescents with diverse chronic illnesses .
-METHODS	Controls received mailed materials on general health topics .
-METHODS	Disease management , health-related self-efficacy , and health assessments were performed at baseline and at 2 and 8 months .
-METHODS	Frequency of patient-initiated communications was recorded over the study period .
-METHODS	Outcomes were analyzed according to assigned treatment group over time .
-RESULTS	MD2Me recipients demonstrated significant improvements in performance of disease management tasks , health-related self-efficacy , and patient-initiated communications compared with controls .
-CONCLUSIONS	Outcomes in ACD improved significantly among recipients of a generic , technology-based intervention .
-CONCLUSIONS	Technology can deliver transition interventions to adolescents with diverse chronic illnesses , and a generic approach offers a cost-effective means of positively influencing transition outcomes .
-CONCLUSIONS	Further research is needed to determine whether improved short-term outcomes translate into an improved transition for ACD .
-
-###24877146
-BACKGROUND	NK cells have anti-HIV activity mediated through killer cell immunoglobulin-like receptors ( KIRs ) .
-BACKGROUND	The current prospective cohort study evaluated whether variation in KIR genes is associated with HIV infection in discordant couples ( DCs ) , where one spouse remains seronegative ( HSN ) despite repeated exposure to the HIV .
-METHODS	KIR was genotyped using PCR SSP .
-METHODS	Viral load and CD4 counts were estimated using commercially available reagents .
-METHODS	Data were analyzed using SPSS software .
-RESULTS	Among the 47 DCs , HSN spouses had significantly ( P = 0.006 ) higher frequencies of KIR3DS1 .
-RESULTS	Regression analysis revealed significant ( P = 0.009 ) association of KIR2DS1 with low viral load .
-RESULTS	KIR2DS4 variant was associated ( P = 0.032 ) with high viral load .
-RESULTS	Three pairs of KIR genes were in strong LD in HSNs and two pairs in HSPs .
-RESULTS	There were 60 KIR genotypes , and 16 are reported the first time in the Indian population .
-RESULTS	Exclusive genotypes were present either in HSPs ( N = 22 , 11 unique genotypes ) or in HSNs ( n = 27 , 9 unique genotypes ) .
-CONCLUSIONS	This study highlights for the first time in the Indian population an association of KIR genes in HIV infection where presence of exclusive and unique genotypes indicates possible association with either HIV infection or with protection .
-
-###25624132
-BACKGROUND	Allergic rhinitis ( AR ) is an inflammatory condition of the nasal mucosa characterized by symptoms of nasal discharge , itching , sneezing , and congestion .
-BACKGROUND	Ocular symptoms are commonly associated with AR and include itching or burning , tearing or watering , and redness .
-BACKGROUND	Intranasal corticosteroids are a mainstay of treatment , and their effect on nasal symptoms is well described .
-OBJECTIVE	To demonstrate that a 14-day course of 200 g/d of nasal fluticasone propionate is superior to placebo in relieving ocular symptoms associated with AR .
-METHODS	This was a randomized , double-blind , parallel group , multicenter study comparing 200 g/d of fluticasone propionate with placebo in patients with seasonal allergic rhinitis .
-METHODS	The primary end point was mean change from baseline in patient-rated reflective total ocular symptom score ( rTOSS ) .
-METHODS	Key secondary end points included mean change from baseline in the morning and evening rTOSS , end-of-treatment assessment of response , and effect on activities of daily living .
-METHODS	The primary analysis was performed using analysis of covariance with a linear fixed-effects model .
-RESULTS	Fluticasone was statistically significantly more efficacious in reducing the ocular symptoms of AR than placebo .
-RESULTS	The least squares mean difference in the change from baseline of rTOSS was -0.36 ( P = .002 ) .
-RESULTS	A statistically significant difference in mean change from baseline was observed in favor of fluticasone for morning and evening rTOSS .
-RESULTS	Significantly more patients taking fluticasone achieved an overall response compared with placebo .
-RESULTS	Fluticasone had a significantly greater effect on daily living activities and was well tolerated .
-CONCLUSIONS	This study supports the efficacy of fluticasone in treating ocular symptoms associated with AR .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01817790 .
-
-###26017129
-BACKGROUND	The Checklist During Multidisciplinary Visits for Reduction of Mortality in Intensive Care Units ( Checklist - ICU ) trial is a pragmatic , two-arm , cluster-randomised trial involving 118 intensive care units in Brazil , with the primary objective of determining if a multifaceted qualityimprovement intervention with a daily checklist , definition of daily care goals during multidisciplinary daily rounds and clinician prompts can reduce inhospital mortality .
-OBJECTIVE	To describe our trial statistical analysis plan ( SAP ) .
-METHODS	This is an ongoing trial conducted in two phases .
-METHODS	In the preparatory observational phase , we collect three sets of baseline data : ICU characteristics ; patient characteristics , processes of care and outcomes ; and completed safety attitudes questionnaires ( SAQs ) .
-METHODS	In the randomised phase , ICUs are assigned to the experimental or control arms and we collect patient data and repeat the SAQ .
-RESULTS	Our SAP includes the prespecified model for the primary and secondary outcome analyses , which account for the cluster-randomised design and availability of baseline data .
-RESULTS	We also detail the multiple mediation models that we will use to assess our secondary hypothesis ( that the effect of the intervention on inhospital mortality is mediated not only through care processes targeted by the checklist , but also through changes in safety culture ) .
-RESULTS	We describe our approach to sensitivity and subgroup analyses and missing data .
-CONCLUSIONS	We report our SAP before closing our study database and starting analysis .
-CONCLUSIONS	We anticipate that this should prevent analysis bias and enhance the utility of results .
-
-###25240700
-BACKGROUND	The aim of this study is to investigate if therapeutic weight loss reduces P wave dispersion .
-METHODS	20 obese patients ( 10 males and 10 females ) , part of a randomized clinical trial , were examined over a 6 month period .
-METHODS	They were treated with a diet , aiming at 5 % weight loss at the 6th month .
-METHODS	After physical examination , they underwent laboratory tests , bioelectrical impedance analysis and a electrocardiogram ( ECG ) .
-METHODS	ECGs were transferred to a personal computer via a scanner and then magnified 400 times .
-METHODS	We examined at baseline and at the 6th month , maximum and minimum P-wave duration , P-wave dispersion and heart rate .
-RESULTS	Comparing responders ( patients who lost 5 % of weight at t6 ) and not responders ( who lost less than 5 % ) , responders showed a significant reduction of P wave dispersion value ( -0.38 [ SD : 0.35 ] mm equal to -32.3 [ SD : 11.3 ] % p = 0.00001 ) .
-RESULTS	All responders present a reduction of P wave dispersion , while for not-responders this is no longer evident .
-RESULTS	Finally , a good degree of correlation ( r = 0.54 ) between P wave dispersion difference and the decrease of weight was noticed .
-RESULTS	Females have a better response in P dispersion reduction strictly connected with their weight loss with a good correlation , ( r = 0.7 , p = 0.002 ) , versus a moderate correlation evidenced in males ( r = 0.5 , p = 0.011 ) .
-CONCLUSIONS	P wave duration and dispersion are significantly reduced in patients who lost more than 5 % of weight and this decrease is highly related to the extent of weight loss .
-
-###24342196
-OBJECTIVE	To evaluate the efficacy and safety of iron protein succinylate ( IPS ) oral solution in preventing and treating anemia of prematurity ( AOP ) .
-METHODS	Sixty premature infants less than 35 weeks of gestation were randomly divided into IPS ( n = 30 ) and polysaccharide iron complex ( PIC ) groups ( n = 30 ) .
-METHODS	Treatment began at two weeks after birth .
-METHODS	The infants received IPS or PIC in addition to recombinant human erythropoietin .
-METHODS	On days 14 , 28 , 42 , and 60 after treatment , hemoglobin ( Hb ) , red blood cell count ( RBC ) , hematocrit ( HCT ) , percentage of reticulocytes , serum iron , and serum ferritin were determined .
-METHODS	Liver and renal functions were evaluated before and after treatment .
-RESULTS	There were significant differences in the changing trends of RBC and HCT between the two groups ( P < 0.05 ) .
-RESULTS	In the IPS group , RBC and HCT gradually decreased after birth , but began to rise gradually on days 28 and 42 of treatment ; in the PIC group , RBC and HCT kept decreasing from birth to day 60 of treatment .
-RESULTS	On day 60 of treatment , the IPS group had significantly higher levels of Hb , RBC , HCT , serum iron , and serum ferritin than the PIC group ( P < 0.05 ) .
-RESULTS	No notable adverse events occurred in either group .
-CONCLUSIONS	IPS oral solution has good efficacy and tolerability in preventing and treating AOP .
-
-###25450242
-OBJECTIVE	To compare the features of capsulotomy obtained during femtosecond laser-assisted cataract surgery with those of continuous curvilinear capsulorhexis ( CCC ) obtained using a standard manual technique .
-METHODS	Ophthalmology Clinic , Department of Medicine and Science of Ageing , University G. D'Annunzio Chieti-Pescara , Chieti , Italy .
-METHODS	Prospective randomized clinical study .
-METHODS	Candidates for cataract extraction were randomized into 1 of 3 groups as follows : Lensx femtosecond laser-assisted cataract surgery capsulotomy ( laser group 1 ) , Lensar femtosecond laser-assisted cataract surgery capsulotomy ( laser group 2 ) , and manual CCC ( manual group ) .
-RESULTS	Each group comprised 30 eyes ( 30 patients ) .
-RESULTS	The capsulotomies in laser group 1 and laser group 2 showed significantly better circularity than the manual CCCs at 7 days ( P < .001 ) .
-RESULTS	There was a significant correlation between the intended versus achieved capsulotomy size in the 2 laser groups .
-RESULTS	Both laser groups had better intraocular lens ( IOL ) centration than the manual group at all timepoints ( P < .001 ) .
-RESULTS	Between-group differences in uncorrected and corrected distance visual acuities were not statistically significant .
-RESULTS	The residual spherical equivalent and mean absolute error were statistically significantly smaller in the 2 laser groups than in the manual group ( P = .038 ) and increased significantly over time in all the groups ( P < .001 ) .
-CONCLUSIONS	Femtosecond laser capsulotomies showed better circularity with more predictable size than manual CCCs .
-CONCLUSIONS	In addition , IOL centration was better immediately after surgery and over time with better refractive results in the 2 laser groups .
-
-###25052076
-OBJECTIVE	To evaluate the effect of automated tube voltage selection on radiation dose and image quality at cardiovascular CT angiography ( CTA ) .
-METHODS	We retrospectively analysed paired studies in 72 patients ( 41 male , 60.516.5 years ) , who had undergone CTA acquisitions of the heart or aorta both before and after the implementation of an automated x-ray tube voltage selection algorithm ( ATVS ) .
-METHODS	All other parameters were kept identical between the two acquisitions .
-METHODS	Subjective image quality ( IQ ) was rated and objective IQ was measured by image noise , signal-to-noise ratio ( SNR ) , contrast-to-noise ratio ( CNR ) and figure of merit ( FOM ) .
-METHODS	Image quality parameters and effective dose were compared between acquisitions .
-RESULTS	Overall subjective image quality improved with the percentage of cases scored as adequate or higher increasing from 79 % to 92 % after implementation of ATVS ( P = 0.03 ) .
-RESULTS	SNR ( 14.15.9 , 15.76.1 , P = 0.009 ) , CNR ( 11.65.3 , 13.25.6 , P = 0.011 ) , and FOM ( 19.923.3 , 43.851.1 , P < 0.001 ) were significantly higher after implementation of ATVS .
-RESULTS	Mean image noise ( 24.18.4 HU , 22.77.1 HU , P = 0.048 ) and mean effective dose ( 10.65.9 mSv , 8.85.0 mSv , P = 0.003 ) were significantly lower after implementation of ATVS .
-CONCLUSIONS	Automated tube voltage selection can operator-independently optimize cardiovascular CTA image acquisition parameters with improved image quality at reduced dose .
-CONCLUSIONS	Automatic tube voltage selection optimizes tube voltage for each individual patient .
-CONCLUSIONS	In this population , overall radiation dose decreased while image quality improved .
-CONCLUSIONS	This tool may become valuable for improving dose/quality ratio .
-
-###24841163
-BACKGROUND	Inhaled corticosteroids ( ICSs ) are widely used in asthma control .
-BACKGROUND	Ciclesonide ( CIC ) is an ICS with on-site lung activation for potent anti-inflammatory activity .
-OBJECTIVE	This study aimed to compare the clinical benefit of CIC with budesonide ( BUD ) in step-down therapy .
-METHODS	A total of 150 patients with mild-to-moderate asthma well controlled by a combination of ICS and long-acting 2-agonist were randomised to receive either CIC 320g ( n = 75 ) once daily or 2 inhalations of BUD 200g ( n = 75 ) twice daily for 12 weeks .
-METHODS	The forced expiratory volume in 1s ( FEV1 ) , maximum mid-expiratory flow ( MMEF ) and asthma control test ( ACT ) scores were measured .
-METHODS	Ranked stratification of patients and physicians was assessed .
-RESULTS	Drug adherence was significantly higher in the CIC group than in the BUD group ( 76.0 % vs. 58.7 % , P = 0.03 ) .
-RESULTS	The FEV1 and MMEF remained stable throughout the 12-week CIC treatment .
-RESULTS	In the BUD group , FEV1 significantly decreased at weeks 4 and 12 .
-RESULTS	MMEF had a higher value in the CIC group than in the BUD group .
-RESULTS	Both patients and physicians ranked CIC over BUD .
-CONCLUSIONS	CIC is more effective and has better drug adherence than BUD as step-down treatment when asthma is well controlled by combination therapy .
-
-###25240140
-BACKGROUND	The efficacy of psychodynamic therapy ( PDT ) for depression is debated due to a paucity of high-quality studies .
-BACKGROUND	We compared short psychodynamic supportive psychotherapy ( SPSP ) to cognitive behavioral therapy ( CBT ) in a randomized clinical trial .
-BACKGROUND	We used therapist-rated outcomes to examine how the course of change during treatment could be best represented and to compare treatment efficacy , hypothesizing non-significant differences .
-METHODS	Three hundred and forty-one adults meeting DSM-IV criteria for a depressive episode and with Hamilton Depression Rating Scale ( HAM-D ) scores 14 were randomized to 16 sessions of individual manualized CBT or SPSP .
-METHODS	Severely depressed patients ( HAM-D > 24 ) received additional antidepressant medication .
-METHODS	After each session , therapists rated the Clinical Global Impression Scale subscales ` Severity of Illness ' ( CGI-S ) and ` Global Improvement ' ( CGI-I ) , and the DSM-IV Axis V Global Assessment of Functioning Scale ( GAF ) .
-METHODS	We fitted growth curves using mixed model analyses with intention-to-treat samples .
-RESULTS	CGI-S and GAF scores during treatment were best represented by a linear symptom decrease .
-RESULTS	CGI-I scores were best represented by an S-shaped curve with relative more improvement in the first and last phases than in the middle phase of treatment .
-RESULTS	No significant post-treatment treatment differences were found .
-RESULTS	A non-significant trend for a treatment effect on CGI-S scores vanished when controlling for therapist gender and profession .
-CONCLUSIONS	Therapists were not specifically trained for CGI and GAF assessments .
-CONCLUSIONS	These findings add to the evidence-base of PDT for depression .
-CONCLUSIONS	Therapist characteristics and differences between severity and improvement measures might influence ratings and need to be taken into account when using therapist-rated outcome measures .
-
-###24809759
-OBJECTIVE	To compare asthma control assessment using the Asthma APGAR system , a tool developed by primary care clinicians , in a multicenter primary care sample with the Asthma Control Test ( ACT ) / Childhood Asthma Control Test ( CACT ) , a tool developed by asthma specialists .
-METHODS	This is a substudy of a multicenter , randomized , controlled pragmatic trial that tests the effectiveness of the Asthma APGAR system in primary care practices .
-METHODS	As part of the study , enrolled patients completed both the ACT/CACT and the Asthma APGAR system between March 1 , 2011 , and December 31 , 2011 .
-METHODS	Kappa and McNemar statistics were used to compare the results of questionnaires .
-RESULTS	Of the 468 patients in our sample , 306 ( 65 % ) were classified as not controlled by the ACT/CACT or the Asthma APGAR system .
-RESULTS	The overall agreement was 84.4 % , with a kappa value of .68 ( substantial agreement ) and a McNemar test P value of .35 ( suggesting no significant difference in the direction of disagreement ) .
-RESULTS	Of those with poor control as defined by the Asthma APGAR system , 23.8 % ( 73 ) had no controller medications and 76.5 % ( 234 ) were seldom or sometimes able to avoid identified triggers for their asthma .
-RESULTS	Of those who stated that they had been prescribed controller medications , 116 of 332 ( 35 % ) stated that they did not use the controller medication on a daily basis .
-CONCLUSIONS	The Asthma APGAR system and the ACT/CACT similarly assess asthma control in a multicenter primary care-based sample .
-CONCLUSIONS	The Asthma APGAR system identified an `` actionable item '' in more than 75 % ( 234 ) of the individuals with poor asthma control , thus linking an assessment of poor asthma control with a management strategy .
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-###25791707
-OBJECTIVE	To evaluate the applicability of magnetic resonance imaging ( MRI ) as a method for monitoring the activity of otospongiotic lesions before and after clinical treatment .
-METHODS	Prospective , randomized , controlled , double-blind study .
-METHODS	One single tertiary care institution in a large , cosmopolitan city .
-METHODS	Twenty-six patients ( n = 42 ears ) with clinical , audiometric , and tomographic diagnosis of otosclerosis were enrolled .
-METHODS	If computed tomography ( CT ) demonstrated active lesions , these patients underwent MRI to detect otospongiotic foci , seen as areas of gadolinium enhancement .
-METHODS	Patients were divided into 3 groups and received treatment with placebo , sodium alendronate , or sodium fluoride for 6 months .
-METHODS	After this period , clinical and audiometric evaluations and a second MRI were performed .
-METHODS	Each MRI was evaluated by both a neuroradiologist and an otolaryngologist in a subjective ( visual ) and objective ( using specific eFilm Workstation software ) manner .
-RESULTS	Otospongiosis was most predominantly identified in the region anterior to the oval window , and this site was reliable for comparing pre - and posttreatment scans .
-RESULTS	The patients in the alendronate and sodium fluoride groups had MRI findings that suggested a decrease in activity of otospongiotic lesions , more relevant in the alendronate group .
-RESULTS	These findings were statistically significant for both subjective and objective MRI evaluations .
-CONCLUSIONS	MRI shows higher sensitivity than clinical or audiometric assessment for detecting reduction in activity of otospongiosis .
-CONCLUSIONS	The objective MRI evaluation based on software analysis was the most accurate method of monitoring clinical treatment response in otospongiosis .
-
-###24462183
-BACKGROUND	The PLATINUM randomized trial enrolled 1530 patients treated with either the platinum chromium PROMUS Element everolimus-eluting stent ( PtCr-EES ; Boston Scientific , Natick , MA , USA ) or the predicate cobalt chromium PROMUS/XIENCE V EES ( CoCr-EES ; manufactured as XIENCE V by Abbott Vascular , Santa Clara , CA , USA also distributed as PROMUS by Boston Scientific ) , including 124 patients from Japanese sites .
-BACKGROUND	This substudy examines 2-year outcomes in the Japanese and non-Japanese cohorts .
-METHODS	Patients with 1 or 2 de novo native coronary artery lesions ( baseline vessel diameter 2.50 mm to 4.25 mm and length 24mm ) were randomized 1:1 to PtCr-EES ( N = 63 patients in Japan ) versus CoCr-EES ( N = 61 patients in Japan ) .
-RESULTS	Several significant differences were noted in baseline demographics , lesion characteristics , and procedural technique between Japanese and non-Japanese patients , including longer fluoroscopy time , less use of contrast , and greater post-dilatation usage and maximum pressure in Japan .
-RESULTS	Dual antiplatelet usage at 2 years was also higher in Japan .
-RESULTS	Despite these differences , the 2-year rates of target lesion failure were comparable in patients treated with PtCr-EES and CoCr-EES both in Japan ( 3.2 % vs 5.0 % respectively , p = 0.68 ) and outside Japan ( 4.7 % vs 5.9 % respectively , p = 0.33 ; p for interaction = 0.82 ) .
-CONCLUSIONS	This PLATINUM study subanalysis suggests that the PtCr-EES and CoCr-EES provide comparable safety and efficacy in both Japanese and non-Japanese patients .
-
-###24350416
-BACKGROUND	Postoperative sore throat ( POST ) is a frequent consequence following ETT intubation , which may negatively affect the postoperative course and patient satisfaction .
-BACKGROUND	Benzydamine hydrochloride is a topically-applied non-steroidal anti-inflammatory drug ( NSAID ) .
-BACKGROUND	The authors evaluated the analgesic effect of benzydamine hydrochloride dripping on the ETT cuff on POST .
-METHODS	Eighty-six patients participated in this randomized controlled trial .
-METHODS	They were assigned into either the benzydamine hydrochloride or the control group .
-METHODS	The whole ETT cuff was dripped either with 3 ml ( 4.5 mg ) of benzydamine hydrochloride or nothing five minutes prior to anesthesia induction .
-METHODS	The incidence and severity of POST at 0 , 2 , 4 , 6 , 12 and 24 hours postoperatively were assessed .
-METHODS	The potential adverse effects of benzydamine hydrochloride ( throat numbness throat burning sensation , dry mouth , and thirst ) were also evaluated .
-RESULTS	Twenty-five patients ( 58.14 % ) in each group had POST ( p-value = 1 ) .
-RESULTS	The severity of POST ( calculated from affected patients ) in both groups at different time points was not significantly different .
-RESULTS	Patients in the benzydamine hydrochloride group did not have a higher incidence of adverse effects .
-CONCLUSIONS	We found that dripping benzydamine hydrochloride on the ETT cuff neither reduced the incidence of POST nor increased the incidence of adverse effects in comparison with no intervention .
-
-###24788217
-BACKGROUND	Inflammatory bowel diseases impose on patients a broad spectrum of somatic and psychosocial burden .
-BACKGROUND	We hypothesized that patients ' self-responsibility in planning and initiating adequate usually multimodal health care can be supported by self-assessment and proactive information , thus improving health-related quality of life and social participation .
-METHODS	We conducted a randomized controlled trial among a random sample of adult members of a German statutory health insurance with Crohn 's disease or ulcerative colitis with at least 1 inflammatory bowel diseases-related hospital stay or sick leave in 2009 or 2010 .
-METHODS	Five hundred fourteen patients completed a postal screening questionnaire inquiring about 22 problems .
-METHODS	The intervention group ( IG ) received an automated data analysis with individualized written advice on appropriate health services , and the control group received usual care .
-METHODS	Main outcomes were health-related quality of life and social participation .
-METHODS	Secondary outcomes included health care utilization , number of screened problems , and self-management skills .
-RESULTS	After 12 months , small beneficial effects were seen for all primary outcomes in the IG : EuroQol visual analog scale score ( difference between IG and control group : 4.4 ; 95 % confidence interval , 7.7-1 .0 ; P = 0.011 ) , index for measuring participation restriction ( IMET ) score ( difference between IG and control group : 0.4 ; 95 % confidence interval , 0.07-0 .62 ; P = 0.013 ) .
-RESULTS	The number of disability days improved only in the IG .
-RESULTS	The IG reported significantly fewer outpatient visits , fewer disease-related problems , and improved self-management skills ( health education impact questionnaire scores ) with no increase in disease activity , hospital stays , or consultations with allied health professionals .
-CONCLUSIONS	Our activation and information procedure is effective and beneficial .
-CONCLUSIONS	Further studies might show its usefulness in comprehensive management of patients with inflammatory bowel diseases .
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-###24225216
-OBJECTIVE	To investigate the significance of dynamic monitoring of procalcitonin ( PCT ) in guiding the use of antibiotics for treating patients with sepsis in intensive care unit ( ICU ) .
-METHODS	Eighty-two patients with sepsis from January 2012 to June 2013 hospitalized in ICU of First Hospital of Jilin University were enrolled , and they were randomly divided into regular antibiotic therapy group ( RAT group , n = 40 ) and PCT monitoring in guiding the use of antibiotics group ( PCT group , n = 42 ) .
-METHODS	Patients in RAT group were treated according to principle of antibiotics usage , while in PCT group patients ' PCT value was observed everyday .
-METHODS	When no active symptoms of infection were shown , and acute physiology and chronic health evaluation II ( APACHEII ) scores declined , PCT value decreased over 90 % or PCT value lower than 0.25 g/L time point were selected as drug withdrawal indication .
-METHODS	The general status of the patient , antimicrobial drug use time , and prognosis were compared between the two groups , and Kaplan-Meier method was used for survival curve analysis .
-METHODS	Variance analysis was used for repeating measurement to observe dynamic serum PCT level of the two groups of patients for survival and death during 7 days .
-RESULTS	Mann-Whitney U test or ( 2 ) test showed that there were no statistical significance in age , gender , APACHEII score , blood culture positive rate , sputum culture positive rate , cardiac insufficiency , renal failure , respiratory failure , and ventilator and hemofiltration usage ( all P > 0.05 ) .
-RESULTS	Log Rank test results showed that the time of antimicrobial drug usage was significantly reduced in PCT group than that in RAT group [ days : 8.10.3 , 95 % confidence interval ( 95 % CI 8.3-9 .7 ) vs. 9.30.3 ( 95 % CI 8.7-10 .1 ) , P = 0.013 ] .
-RESULTS	Kaplan-Meier univariate survival curves showed that the speed of curve declination in PCT group was faster significantly than that in RAT group , suggesting that the time of using antimicrobial drug was shortened .
-RESULTS	There was no significant difference in length of hospital stay , ICU stay time , number of death in 28 days , number of cases of recurrence in 28 days and clinical cure rate between two groups ( all P > 0.05 ) .
-RESULTS	PCT level in non-survivors in both groups was significantly higher than that in the survivors , exceeding more than 10 g/L in the early and late stages of treatment .
-CONCLUSIONS	Dynamic monitoring of PCT can effectively reduce antimicrobial drug use in ICU patients with sepsis , but there is no significant difference in patients ' prognosis .
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-###24524806
-OBJECTIVE	The PDY6797 study evaluated efficacy , safety and pharmacodynamics of lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus ( T2DM ) insufficiently controlled with sulphonylureas with/without metformin .
-METHODS	This randomized , double-blind , placebo-controlled trial comprised a single-dose assessment of lixisenatide 5 and 10g , and a 5 - to 6-week repeated dose-escalation assessment of lixisenatide 5 to 30g once ( QD ) or twice daily ( BID ) .
-METHODS	The primary endpoint was change in postprandial plasma glucose ( PPG ) area under the curve ( AUC ) [ 0:29 -4:30 h ] after a standardized breakfast at the highest tolerated lixisenatide dose .
-METHODS	Change from baseline in glycated haemoglobin ( HbA1c ) , 2-h PPG and fasting plasma glucose ( FPG ) were assessed , as were adverse events .
-RESULTS	Change from baseline in PPG AUC [ 0:29 -4:30 h ] with lixisenatide QD and BID was significantly greater than placebo ( p < 0.0001 for all study populations ) , with particularly prominent effects in Japanese patients .
-RESULTS	Greater reductions in PPG AUC [ 0:29 -4:30 h ] were seen with lixisenatide QD versus BID , while the totality of evidence suggested that the lixisenatide 20g dose was optimal .
-RESULTS	In the overall population , changes from baseline for 2-h PPG , HbA1c and FPG were significant with lixisenatide QD and BID versus placebo ( p < 0.01 for all ) .
-RESULTS	Lixisenatide was well tolerated .
-CONCLUSIONS	Lixisenatide significantly reduced PPG AUC [ 0:29 -4:30 h ] versus placebo at the highest well-tolerated dose in patients with T2DM treated with sulphonylureas with/without metformin and had a good safety and tolerability profile .
-CONCLUSIONS	Japanese patients experienced particular benefits with lixisenatide in terms of reductions in PPG excursions .
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-###25867812
-BACKGROUND	Relatively low radioiodine uptake ( RAIU ) represents a common obstacle for radioiodine ( ( 131 ) I ) therapy in patients with multinodular goiter complicated by hyperthyroidism .
-OBJECTIVE	To evaluate whether thiamazole ( MTZ ) pretreatment can increase ( 131 ) I therapeutic efficacy .
-METHODS	Twenty-two patients with multinodular goiter , subclinical hyperthyroidism , and RAIU < 50 % were randomized to receive either a low-iodine diet ( LID ; n = 10 ) or MTZ 30 mg/d ( n = 12 ) for 42 days .
-METHODS	Thyroid function and 24-hour RAIU were measured before and after treatment .
-METHODS	Thyroid volume was evaluated by either magnetic resonance imaging or single photon emission computed tomography .
-RESULTS	Mean 24-hour RAIU increased significantly from 32 10 % to 63 18 % in the MTZ group ( P < .001 ) .
-RESULTS	Consequently , there was a 31 % decrease in the calculated median therapeutic ( 131 ) I activity after MTZ ( P < .05 ) .
-RESULTS	No significant changes in 24-hour RAIU were observed after diet .
-RESULTS	In the MTZ group , median serum TSH levels increased significantly by 9 % and mean serum free T4 and free T3 concentrations decreased by 22 % and 15 % , respectively , whereas no changes in thyroid function were observed in the LID group .
-RESULTS	Thyroid volume did not significantly change in either of the two groups .
-RESULTS	At 12 months after radioiodine treatment , median serum TSH was within the normal range in both groups .
-CONCLUSIONS	MTZ treatment before ( 131 ) I therapy resulted in an average 2-fold increase in thyroid RAIU and enhanced the efficiency of radioiodine therapy assessed at 12 months .
-CONCLUSIONS	MTZ pretreatment is therefore a safe , easily accessible alternative to recombinant human TSH stimulation and a more effective option than LID .
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-###25898472
-OBJECTIVE	To evaluate pregnancy rates based on the route of progesterone replacement in frozen embryo transfer ( FET ) cycles .
-METHODS	A randomized controlled trial and retrospective analysis .
-METHODS	In the randomized group 76 FET cycles were randomized .
-METHODS	In the retrospective group 508 FET cycles were reviewed .
-METHODS	Intramuscular ( IM ) proges-erone in oil 100 mg daily or oral micronized progesterone prior to transfer followed by compounded vaginal proges-erone 200 mg 3 times daily ( OV ) .
-METHODS	The main outcome measure was the clinical pregnancy rate ( CPR ) .
-RESULTS	Baseline characteristics did not vary be-ween groups in either cohort .
-RESULTS	In the randomized group there were no significant differences in CPR ( 31.43 % vs. 21.05 % ) or live birth rate ( LBR ) ( 31.43 % vs. 18.92 % ) for IM and OV progesterone replacement , respectively .
-RESULTS	In the retrospective cohort patients there wore also no significant differences in CPR ( 35.56 % vs. 32.35 % ) or LBR ( 32.23 % vs. 28.51 % ) f or the IM and OVp rogester-ne replacement groups , respectively .
-CONCLUSIONS	This study demonstrates that either OV or IM progesterone is effective for luteal phase support for FETs .
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-###24785925
-BACKGROUND	Surgically assisted rapid palatal expansion ( SARPE ) is the procedure of choice for treatment of adults with transverse maxillary deficiency greater than 7 mm .
-BACKGROUND	There is no consensus about the dentoskeletal effect of an orthodontic retainer on the outcome of SARPE .
-BACKGROUND	Our objective was to assess the effectiveness of an orthodontic retainer on dentoskeletal stability .
-METHODS	Ninety digitized dental casts of 30 adults undergoing SARPE were divided into 2 groups-no retention ( n = 15 ) and retention ( n = 15 ) - and assessed .
-METHODS	The dental casts were obtained at 3 checkpoints : ( 1 ) 7 days on average before SARPE ( preoperatively ) , ( 2 ) 4 months after expansion , and ( 3 ) 10 months after expansion was completed .
-METHODS	The retention patients received a transpalatal arch just after expander removal , at checkpoint 2 .
-METHODS	The transpalatal arch was kept for 10 months after completion of the expansion ( checkpoint 3 and end of the study ) .
-METHODS	The dental casts were scanned with a Vivid 9i 3D laser scanner ( Konica Minolta , Wayne , NJ ) .
-METHODS	The distances measured were premolar and molar intercusp distances , premolar and molar intercervical distances , premolar and molar inter-WALA ( Will Andrews and Lawrence Andrews ) ridge distances , and palate height at the maxillary first molar .
-RESULTS	The planned maxillary expansion was within the expected amount ( P < 0.05 ) .
-RESULTS	Palatal height at the 4-month checkpoint decreased by 0.79 mm ( 4.38 % ) ( P < 0.001 ) and again at the 10-month checkpoint by 0.38 mm ( 0.98 % ) ( P > 0.05 ) but not significantly in both groups .
-RESULTS	The premolar intercusp distance had a relapse at checkpoint 3 of 1.84 mm ( 7.18 % ) ( P < 0.001 ) in the no-retention group .
-RESULTS	Both groups had average relapses of 0.95 mm in the premolar intercervical distances , of 0.88 mm in the premolar inter-WALA ridge distances , of 1.04 mm in the molar intercusp distances , of 0.74 mm in the molar intercervical distances , and of 0.84 mm in the molar inter-WALA ridge distances ( P < 0.05 ) at checkpoint 3 .
-CONCLUSIONS	The analysis of relapse in both groups suggests that the use of a transpalatal arch as a retaining device does not improve dento-osseous stability .
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-###26066615
-BACKGROUND	Acellular dermal matrix ( ADM ) has been used for antiadhesion formation along with wound healing in various surgical fields .
-OBJECTIVE	The aim is to assess the efficacy of ADM implantation in the prevention of postoperative scars and adhesions after conventional , open , total thyroidectomy .
-METHODS	Forty-four patients with papillary thyroid carcinoma undergoing thyroidectomy were randomly assigned to the study ( ADM implantation ) or control group ( without ADM ) .
-METHODS	Global photographic assessment , Vancouver scar scale ( VSS ) , objective scar assessment , and swallowing impairment index were assessed at baseline , immediately after surgery , and at 1 and 2 months after surgery .
-RESULTS	Nineteen control and 20 study group participants completed the study .
-RESULTS	The mean VSS score of the study group was significantly lower than the controls at both 1 month ( 3.06 1.25 vs 4.41 1.54 , respectively ) and 2 months ( 2.76 1.56 vs 4.35 1.58 , respectively ) after surgery .
-RESULTS	Scar quality measures ( mean melanin and erythema indexes ) were significantly lower in the study group compared with controls .
-RESULTS	Study group participants had significantly lower swallowing impairment scores than controls .
-RESULTS	The mean postoperative hospitalization of both groups was not significantly different .
-CONCLUSIONS	Acellular dermal matrix-assisted implants appear to improve post-thyroidectomy scar and swallowing impairments without delays in operation time .
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-###24249049
-BACKGROUND	Heart failure with preserved ejection fraction ( HFpEF ) is associated with substantial morbidity and mortality .
-BACKGROUND	Existing data on cardiac structure and function in HFpEF suggest significant heterogeneity in this population .
-RESULTS	Echocardiograms were obtained from 935 patients with HFpEF ( left ventricular ejection fraction 45 % ) enrolled in the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist ( TOPCAT ) trial before initiation of randomized therapy .
-RESULTS	Average age was 7010 years , 49 % were women , 14 % were of African descent , and comorbidities were highly prevalent .
-RESULTS	Centralized quantitative analysis in a blinded core laboratory demonstrated a mean left ventricular ejection fraction of 59.37.9 % , with prevalent concentric left ventricular remodeling ( 34 % ) and hypertrophy ( 43 % ) , and left atrial enlargement ( 53 % ) .
-RESULTS	Diastolic dysfunction was present in 66 % of gradable participants and was significantly associated with greater left ventricular hypertrophy and a higher prevalence of left atrial enlargement .
-RESULTS	Doppler evidence of pulmonary hypertension was present in 36 % .
-RESULTS	At least 1 measure of structural heart disease was present in 93 % of patients .
-CONCLUSIONS	Patients enrolled in TOPCAT demonstrated heterogeneous patterns of ventricular remodeling , with high prevalence of structural heart disease , including left ventricular hypertrophy and left atrial enlargement , in addition to pulmonary hypertension , each of which has been associated with adverse outcomes in HFpEF .
-CONCLUSIONS	Diastolic function was normal in approximately one third of gradable participants , highlighting the heterogeneity of the cardiac phenotype in this syndrome .
-CONCLUSIONS	These findings deepen our understanding of the TOPCAT trial population and expand our knowledge of the diversity of the cardiac phenotype in HFpEF .
-BACKGROUND	URL : http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00094302 .
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-###24286966
-OBJECTIVE	This study examined the relationships between treatment fidelity and treatment outcomes in a community-based trial of a 12-Step Facilitation ( TSF ) intervention .
-METHODS	In a prior multi-site randomized clinical trial , 234 participants in 10 outpatient drug treatment clinics were assigned to receive the Stimulant Abuser Groups to Engage in 12-Step ( STAGE-12 ) intervention .
-METHODS	A secondary analysis reviewed and coded all STAGE-12 sessions for fidelity to the protocol , using the Twelve Step Facilitation Adherence Competence Empathy Scale ( TSF ACES ) .
-METHODS	Linear mixed-effects models tested the relationship between three fidelity measures ( adherence , competence , empathy ) and six treatment outcomes ( number of days of drug use and five Addiction Severity Index ( ASI ) composite scores ) measured at 3 months post-baseline .
-RESULTS	Adherence , competence and empathy were robustly associated with improved employment status at follow up .
-RESULTS	Empathy was inversely associated with drug use , as was competence in a non-significant trend ( p = .06 ) .
-RESULTS	Testing individual ASI drug composite score items suggested that greater competence was associated with fewer days of drug use and , at the same time , with an increased sense of being troubled or bothered by drug use .
-CONCLUSIONS	Greater competence and empathy in the delivery of a TSF intervention were associated with better drug use and employment outcomes , while adherence was associated with employment outcomes only .
-CONCLUSIONS	Higher therapist competence was associated with lower self-report drug use , and also associated with greater self-report concern about drug use .
-CONCLUSIONS	The nature of TSF intervention may promote high levels of concern about drug use even when actual use is low .
-
-###24799054
-OBJECTIVE	Clinical activity of chemotherapy plus trastuzumab in HER2 overexpressing advanced breast cancer has been documented .
-OBJECTIVE	We report the activity and safety results of biweekly combination of trastuzumab , docetaxel and gemcitabine as first-line therapy in HER2-positive advanced breast cancer .
-METHODS	Patients were biweekly treated with trastuzumab ( 4 mg/kg ) , gemcitabine ( 1000 mg/m ( 2 ) ) and docetaxel ( 50 mg/m ( 2 ) ) .
-METHODS	The primary end point was overall response rate , secondary time to progression , clinical benefit rate ( partial response plus complete response plus stable disease for 24 weeks ) and tolerability .
-RESULTS	A total of 65 patients with HER2-positive advanced breast cancer have been enrolled .
-RESULTS	In total , 47 patients responded ( 73 % ; 95 % CI , 60-84 ) , 11 achieved complete response ( 17 % ; 95 % CI : 8.9-28 .7 ) , 36 achieved partial response ( 56 % ; 95 % CI : 43-68 .6 ) .
-RESULTS	The clinical benefit rate was 87.5 % ( 95 % CI : 77-94 ) .
-RESULTS	Three patients ( 4.7 % ) experienced progressive disease .
-RESULTS	The median time to progression was 14.2 months ( 95 % CI : 10.6-17 .8 ) , the median overall survival was 39.3 months and the 36-month survival rate was 55.5 % ( 95 % CI : 58-73 ) .
-RESULTS	The worst toxicities were grade 3 neutropenia ( 12 % ) , thrombocytopenia ( 6 % ) and diarrhea ( 6 % ) .
-RESULTS	No cardiac toxicity was reported .
-CONCLUSIONS	As first-line therapy , this combination allowed the delivery of polychemotherapy in association to targeted therapy , with clinical activity and mild toxicity .
-CONCLUSIONS	The promising results should be further explored in Phase III randomized clinical trials .
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-###24285491
-OBJECTIVE	To assess whether in early ( rheumatoid ) arthritis ( RA ) patients , metacarpal bone mineral density ( BMD ) loss after 4months predicts radiological progression after 1year of antirheumatic treatment .
-METHODS	Metacarpal BMD was measured 4 monthly during the first year by digital X-ray radiogrammetry ( DXR-BMD ) in patients participating in the IMPROVED study , a clinical trial in 610 patients with recent onset RA ( 2010 criteria ) or undifferentiated arthritis , treated according to a remission ( disease activity score < 1.6 ) steered strategy .
-METHODS	With Sharp/van der Heijde progression 0.5 points after 1year ( yes/no ) as dependent variable , univariate and multivariate logistic regression analyses were performed .
-RESULTS	Of 428 patients with DXR-BMD results and progression scores available , 28 ( 7 % ) had radiological progression after 1year .
-RESULTS	Independent predictors for radiological progression were presence of baseline erosions ( OR ( 95 % CI ) 6.5 ( 1.7 to 25 ) ) and early DXR-BMD loss ( OR ( 95 % CI ) 1.5 ( 1.1 to 2.0 ) ) .
-RESULTS	In 366 ( 86 % ) patients without baseline erosions , early DXR-BMD loss was the only independent predictor of progression ( OR ( 95 % CI ) 2.0 ( 1.4 to 2.9 ) ) .
-CONCLUSIONS	In early RA patients , metacarpal BMD loss after 4months of treatment is an independent predictor of radiological progression after 1year .
-CONCLUSIONS	In patients without baseline erosions , early metacarpal BMD loss is the main predictor of radiological progression .
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-###24969260
-OBJECTIVE	To compare the effectiveness of two low-intensity approaches for distressed patients with cancer and caregivers who had called cancer helplines seeking support .
-OBJECTIVE	Baseline distress was hypothesized as a moderator of intervention effect .
-METHODS	Randomized trial .
-METHODS	Community-based cancer helplines in Queensland and New South Wales , Australia .
-METHODS	354 patients with cancer and 336 caregivers .
-METHODS	Participants were randomized to either a single session of nurse-led self-management intervention or a five-session psychologist cognitive behavioral intervention delivered by telephone .
-METHODS	Assessments were undertaken at baseline ( preintervention ) and at 3 , 6 , and 12 months .
-METHODS	Psychological and cancer-specific distress and post-traumatic growth .
-RESULTS	No significant moderation by baseline cancer-specific distress was noted .
-RESULTS	For low-education patients , only the psychologist intervention was associated with a significant drop in distress .
-RESULTS	For all other participants , distress decreased over time in both arms with small to large effect sizes ( Cohen 's ds = 0.05-0 .82 ) .
-RESULTS	Post-traumatic growth increased over time for all participants ( Cohen 's ds = 0.6-0 .64 ) .
-CONCLUSIONS	Many distressed patients with cancer and their caregivers may benefit significantly from a single session of a nurse psychoeducation intervention that can be delivered remotely by telephone and supported by self-management materials .
-CONCLUSIONS	Research is needed to develop an algorithm that moves beyond the use of distress as the only indicator for referral to specialist psychological services .
-CONCLUSIONS	Survivors and caregivers with low education and low literacy may require more in-depth and targeted support .
-CONCLUSIONS	Brief nurse psychoeducation and stress management for cancer survivors and caregivers should be considered as part of a tiered approach to psychosocial care .
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-###25684224
-OBJECTIVE	To compare the effectiveness of controlled-released carbamazepine ( CR-CBZ ) to levetiracetam ( LEV ) and to lamotrigine ( LTG ) in elderly patients with newly diagnosed focal epilepsy .
-METHODS	Randomized , double-blind , parallel-group trial conducted between January 2007 and August 2011 , in 47 ambulatory or hospital sites in Germany , Austria , or Switzerland .
-METHODS	Eligible participants were aged 60 , had new-onset epilepsy , had no acute illness as the cause of their seizures , and had no contraindication to the drugs in the trial .
-METHODS	Patients were randomized 1:1:1 to CR-CBZ , LTG , or LEV .
-METHODS	Doses were up-titrated for 6 weeks and could be maintained or adjusted depending on seizure relapse or tolerability over an additional period of 52 weeks .
-METHODS	Primary outcome was the retention to treatment at week 58 ; secondary measures related to seizure and adverse event frequency .
-RESULTS	Of 361 randomized patients , 359 were included ( CR-CBZ n = 121 , LTG n = 117 , LEV n = 122 ) in the modified intent-to-treat population ( mean age [ range ] 71.4 [ 60-95 ] years ) .
-RESULTS	At week 58 , the retention rate for LEV was significantly higher than for CR-CBZ ( 61.5 % vs. 45.8 % , p = 0.02 ) , and similar to LTG ( 55.6 % ) .
-RESULTS	Seizure freedom rates at weeks 30 and 58 were not different across the groups .
-RESULTS	Twice as many patients receiving CR-CBZ discontinued due to adverse events or death compared to those in the LEV group ( 32.2 % vs. 17.2 % ; odds ratio 2.28 , 95 % confidence interval [ CI ] 1.25-4 .19 , p = 0.007 ) , whereas discontinuation was intermediate for LTG ( 26.3 % ) .
-RESULTS	Median daily doses of completers ( n = 195 ) were CR-CBZ 380.0 mg/day ( 333.0-384 .0 ) , LTG 95 mg/day ( 94.0-97 .0 ) , and LEV 950 mg/day ( 940.0-985 .0 ) .
-CONCLUSIONS	In the initial monotherapy of focal epilepsy in the elderly , 1-year retention to LEV was higher compared to CR-CBZ due to better tolerability .
-CONCLUSIONS	Retention of LTG was intermediate and close to LEV , but did not differ significantly from either comparators .
-CONCLUSIONS	NCT00438451 , www.clinicaltrials.gov .
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-###25332492
-OBJECTIVE	To determine whether an evidence-based pediatric outpatient intervention for parents who smoke persisted after initial implementation .
-METHODS	A cluster randomized controlled trial of 20 pediatric practices in 16 states that received either Clinical and Community Effort Against Secondhand Smoke Exposure ( CEASE ) intervention or usual care .
-METHODS	The intervention provided practices with training to provide evidence-based assistance to parents who smoke .
-METHODS	The primary outcome , assessed by the 12-month follow-up telephone survey with parents , was provision of meaningful tobacco control assistance , defined as discussing various strategies to quit smoking , discussing smoking cessation medication , or recommending the use of the state quitline after initial enrollment visit .
-METHODS	We also assessed parental quit rates at 12 months , determined by self-report and biochemical verification .
-RESULTS	Practices ' rates of providing any meaningful tobacco control assistance ( 55 % vs 19 % ) , discussing various strategies to quit smoking ( 25 % vs 10 % ) , discussing cessation medication ( 41 % vs 11 % ) , and recommending the use of the quitline ( 37 % vs 9 % ) were all significantly higher in the intervention than in the control groups , respectively ( P < .0001 for each ) , during the 12-month postintervention implementation .
-RESULTS	Receiving any assistance was associated with a cotinine-confirmed quitting adjusted odds ratio of 1.89 ( 95 % confidence interval : 1.13-3 .19 ) .
-RESULTS	After controlling for demographic and behavioral factors , the adjusted odds ratio for cotinine-confirmed quitting in intervention versus control practices was 1.07 ( 95 % confidence interval : 0.64-1 .78 ) .
-CONCLUSIONS	Intervention practices had higher rates of delivering tobacco control assistance than usual care practices over the 1-year follow-up period .
-CONCLUSIONS	Parents who received any assistance were more likely to quit smoking ; however , parents ' likelihood of quitting smoking was not statistically different between the intervention and control groups .
-CONCLUSIONS	Maximizing parental quit rates will require more complete systems-level integration and adjunctive cessation strategies .
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-###25069621
-OBJECTIVE	To examine the feasibility , acceptability , and initial efficacy of a technology-based weight loss intervention for urban , low-income mothers .
-METHODS	Eighteen obese , ethnic minority , socioeconomically disadvantaged mothers in the first year after childbirth were randomly assigned to either : 1 ) technology-based intervention , which included empirically supported behavior-change strategies , daily skills , and self-monitoring text messages with personalized feedback , biweekly counseling calls from a health coach , and access to a Facebook support group , or 2 ) usual-care control .
-RESULTS	After 14 weeks of treatment , the technology-based intervention participants had significantly greater weight loss ( -2.9 3.6 kg ) than usual care ( 0.5 2.3 kg ; adjusted mean difference : -3.2 kg , 95 % confidence interval -6.2 to -0.1 kg , P = .04 ) .
-RESULTS	One-third of intervention participants ( 3 of 9 ) and no control participants lost > 5 % of their initial body weight at follow up .
-CONCLUSIONS	Results suggest the potential for using technology to deliver a postpartum weight loss intervention among low-income racial/ethnic minorities .
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-###24727325
-OBJECTIVE	A let-7 microRNA-complementary site ( LCS6 ) polymorphism in the 3 ' untranslated region of the KRAS gene has been shown to disrupt let-7 binding and upregulate KRAS expression .
-OBJECTIVE	We evaluated the LCS6 genotype and its association with KRAS mutation status , clinicopathologic features , and disease-free survival ( DFS ) in patients with stage III colon cancer who enrolled in a phase III clinical trial ( NCCTG N0147 ) .
-METHODS	The LCS6 genotype was assayed by real-time PCR in DNA extracted from whole blood ( n = 2,834 ) and compared with paired tumor tissue ( n = 977 ) .
-METHODS	( 2 ) and two-sample t tests were used to compare baseline factors and KRAS mutation status between patients defined by LCS6 variant status .
-METHODS	Log-rank tests and multivariate Cox models assessed associations between LCS6 status and DFS , respectively .
-RESULTS	We identified 432 ( 15.2 % ) blood samples and 143 ( 14.6 % ) tumor samples heterozygous or homozygous for the LCS6 G-allele , and 2,402 of 2,834 ( 84.8 % ) blood samples and 834 of 977 ( 85.4 % ) tumor samples homozygous for the LCS6 T-allele .
-RESULTS	Genotype results were highly concordant ( 99.8 % ) in cases with paired blood and tumor tissue ( n = 977 ) .
-RESULTS	G-allele carriers were significantly more frequent in Caucasians versus other races ( ( 2 ) test , P < 0.0001 ) .
-RESULTS	The LCS6 genotype was not associated with KRAS mutation status , clinicopathologic features ( all P > 0.2 ) , or DFS ( log-rank P = 0.49 ; HR , 0.929 ; 95 % confidence interval , 0.76-1 .14 ) , even after combining LCS6 genotype with KRAS mutation status .
-CONCLUSIONS	In the largest association study investigating the LCS6 polymorphism in colon cancers , the germline LCS6 genotype was not associated with KRAS mutation status or with clinical outcome in patients with stage III tumors .
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-###24279638
-OBJECTIVE	To assess whether an interdisciplinary intervention is more effective than usual care for improving the health-related quality of life ( HRQoL ) among patients with fibromyalgia ( FM ) , and to identify variables that were predictors of improvement in HRQoL .
-METHODS	In a randomized controlled clinical trial carried out on an outpatient basis in a hospital pain management unit , 153 patients with FM were randomly allocated to an experimental group ( EG ) or a control group ( CG ) .
-METHODS	Participants completed the Fibromyalgia Impact Questionnaire ( FIQ ) at baseline and 6months after the intervention .
-METHODS	The EG received an interdisciplinary treatment ( 12 sessions for 6weeks ) which consisted of coordinated psychological , medical , educational , and physiotherapeutic interventions while the CG received standard-of-care pharmacologic treatment .
-METHODS	Descriptive statistics , ANOVA , Chi square and Fisher tests and generalized linear models were used for data analysis .
-RESULTS	Six months after the intervention , statistically significant improvements in HRQoL were observed in physical functioning ( P = 0.01 ) , pain ( P = 0.03 ) and total FIQ score ( P = 0.04 ) in the EG compared to the CG .
-RESULTS	The number of physical illnesses was identified as a predictor for improvement .
-CONCLUSIONS	This interdisciplinary intervention has shown effectiveness in improving the HRQoL of this sample of patients with FM .
-CONCLUSIONS	The number of physical illnesses was identified as a predictor of that improvement .
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-###24616448
-OBJECTIVE	To determine the short-term efficacy of oral glucosamine supplementation by evaluating structural lesions in the knee joints , as assessed using 3T magnetic resonance imaging ( MRI ) .
-METHODS	This study was designed as a randomized , double-blind , placebo-controlled trial .
-METHODS	Recruitment was performed via mass mailings and an arthritis registry in southwestern Pennsylvania .
-METHODS	In total , 201 participants with mild-to-moderate pain in one or both knees , as defined by a Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) pain score 25 and 100 , were enrolled .
-METHODS	Of these subjects , 69.2 % had a Kellgren/Lawrence grade 2 in at least 1 knee .
-METHODS	Participants received 24 weeks of treatment with 1,500 mg glucosamine hydrochloride in beverage form or a placebo beverage .
-METHODS	The primary outcome was decreased worsening of cartilage damage on 3T MRI of both knees , assessed according to a validated scoring system , the Whole-Organ MRI Score ( WORMS ) .
-METHODS	Secondary outcomes included change in bone marrow lesion ( BML ) scores in all knees and change in excretion of urinary C-terminal crosslinking telopeptide of type II collagen ( CTX-II ) .
-RESULTS	The adjusted odds ratio ( OR ) for the likelihood of decreased cartilage damage over 24 weeks in any WORMS-scored subregion of the knee in the glucosamine treatment group compared to the control group was 0.938 ( 95 % confidence interval [ 95 % CI ] 0.528 , 1.666 ) .
-RESULTS	Compared to subjects treated with glucosamine , control subjects showed more improvement in BMLs ( adjusted OR 0.537 , 95 % CI 0.291 , 0.990 ) but no difference in worsening BMLs ( adjusted OR 0.691 , 95 % CI 0.410 , 1.166 ) over 24 weeks .
-RESULTS	There was no indication that treatment with glucosamine decreased the excretion of urinary CTX-II ( = -0.10 , 95 % CI -0.21 , 0.002 ) .
-CONCLUSIONS	The results of this short-term study provide no evidence of structural benefits ( i.e. , improvements in MRI morphologic features or urinary CTX-II excretion ) from glucosamine supplementation in individuals with chronic knee pain .
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-###24884501
-BACKGROUND	Polymorphisms of genes encoding the Fcy receptors ( Fc fragment of IgG receptor 2A ( FCGR2A ) and 3A ( FCGR3A ) ) , which influence their affinity for the Fc fragment , have been linked to the pharmacodynamics of monoclonal antibodies .
-BACKGROUND	Most studies have been limited by small samples sizes and have reported inconsistent associations between the FCGR2A and the FCGR3A polymorphisms and clinical outcome in metastatic colorectal cancer ( mCRC ) patients treated with cetuximab .
-BACKGROUND	We investigated the association of these polymorphisms and clinical outcome in a large cohort of mCRC patients treated with first-line 5-fluorouracil/folinic acid and oxaliplatin ( Nordic FLOX ) + / - cetuximab in the NORDIC-VII study ( NCT00145314 ) .
-METHODS	504 and 497 mCRC patients were evaluable for the FCGR2A and FCGR3A genotyping , respectively .
-METHODS	Genotyping was performed on TaqMan ABI HT 7900 ( Applied Biosystems , Foster City , CA , USA ) with pre-designed SNP genotyping assays for FCGR2A ( rs1801274 ) and FCGR3A ( rs396991 ) .
-RESULTS	The response rate for patients with the FCGR2A R/R genotype was significantly increased when cetuximab was added to Nordic FLOX ( 31 % versus 53 % , interaction P = 0.03 ) , but was not significantly different compared to the response rate of patients with the FCGR2A H/H or H/R genotypes given the same treatment .
-RESULTS	A larger increase in response rate with the addition of cetuximab to Nordic FLOX in patients with KRAS mutated tumors and the FCGR2A R/R genotype was observed ( 19 % versus 50 % , interaction P = 0.04 ) .
-RESULTS	None of the FCGR3A polymorphisms were associated with altered response when cetuximab was added to Nordic FLOX ( interaction P = 0.63 ) .
-RESULTS	Neither of the FCGR polymorphisms showed any significant associations with progression-free survival or overall survival .
-CONCLUSIONS	Patients with KRAS mutated tumors and the FCGR2A R/R polymorphism responded poorly when treated with chemotherapy only , and experienced the most benefit of the addition of cetuximab in terms of response rate .
-
-###25112521
-BACKGROUND	There is a large body of evidence for the involvement of the parietal cortex in orientation and navigation in space .
-BACKGROUND	This has been supplemented by investigation of the contribution of a number of subregions using transcranial magnetic stimulation .
-OBJECTIVE	The role of the precuneus area , located in the medial plane of posterior parietal cortex ( PPC ) , in visuospatial functions is not well understood .
-OBJECTIVE	We investigated the contribution of this area using the landmark task .
-METHODS	Participants were asked to make forced-choice judgments of which side of prebisected line was longer for near and far viewing conditions ( 70 and 180cm , respectively ) .
-METHODS	Online 10Hz , repetitive transcranial magnetic stimulation ( rTMS ) was delivered for 500ms over the right precuneus , rPPC and vertex ( control ) , in separate blocks of trials .
-METHODS	The rPPC stimulation was used as a positive control , having previously resulted in `` neglect like '' spatial bias effects in a number of studies .
-RESULTS	A no-TMS condition showed a leftward spatial bias ( pseudoneglect ) for near space judgments but not for far space and was used as the baseline .
-RESULTS	Precuneus stimulation resulted in rightward spatial bias from the midpoint in near space similar to the rPPC neglect-like effect .
-RESULTS	No significant effects were seen with vertex stimulation .
-CONCLUSIONS	This study shows that precuneus , like other parietal areas , is involved in visuospatial functions .
-CONCLUSIONS	Further work is required to clarify how the contribution of this area differs from other parietal regions .
-
-###26126565
-OBJECTIVE	To determine whether Care Navigation ( CN ) , a nurse-led hospital-based coordinated care intervention , reduced the use of hospital services and improved quality of life for patients with chronic illness .
-METHODS	Randomised controlled trial ; participants were allocated to CN or standard care .
-METHODS	Patients with chronic illness presenting to the emergency department of Nepean Hospital , Sydney , New South Wales .
-METHODS	High-risk status for an unplanned admission was defined as i ) three or more unplanned hospital admissions in 12 months for patients aged 70 or at least one admission for cardiac or respiratory disease in patients aged 16-69 years ; or ii ) judged by a CN nurse to be high risk and likely to benefit .
-METHODS	Numbers of re-presentations or readmissions , quality of life , time to re-presentation , readmission or death , length of stay , and access to hospital and community health services .
-RESULTS	500 participants were randomised between May 2010 and February 2011 ; 359 by previous unplanned admission and 141 by clinical impression .
-RESULTS	The CN group received more community health services ( rate ratio , 1.94 ; 95 % CI , 1.35-2 .81 ; P < 0.001 ) than participants receiving standard care ; however , this did not result in statistically significant differences in number of re-presentations ( rate ratio , 0.83 ; 95 % CI , 0.68-1 .01 ; P = 0.07 ) , number of readmissions ( rate ratio , 0.85 ; 95 % CI , 0.70-1 .04 ; P = 0.11 ) , quality of life at 24 months ( mean difference , 0 ; 95 % CI , -0.10 to 0.09 , P = 0.93 ) , or other measures .
-CONCLUSIONS	CN did not improve quality of life or reduce unplanned hospital presentations or admissions despite community health services almost doubling .
-CONCLUSIONS	Future service development should explore potential benefits of linking navigated intrahospital care to ongoing , proactive care planning and delivery in the community .
-BACKGROUND	ACTRN12609000554268 .
-
-###24952836
-OBJECTIVE	For people with chronic low back pain , does Kinesio Taping , applied according to the treatment manual to create skin convolutions , reduce pain and disability more than a simple application without convolutions ?
-METHODS	Randomised trial with concealed allocation , intention-to-treat analysis and blinded assessment of some outcomes .
-METHODS	148 participants with chronic non-specific low back pain .
-METHODS	Experimental group participants received eight sessions ( over four weeks ) of Kinesio Taping applied according to the Kinesio Taping Method treatment manual ( ie , 10 to 15 % tension applied in flexion to create skin convolutions in neutral ) .
-METHODS	Control group participants received eight sessions ( over four weeks ) of Kinesio Taping with no tension , creating no convolutions .
-METHODS	The primary outcome measures were pain intensity and disability after the four-week intervention .
-METHODS	Secondary outcomes were pain intensity and disability 12 weeks after randomisation , and global perceived effect at both four and 12 weeks after randomisation .
-RESULTS	Applying Kinesio Tape to create convolutions in the skin did not significantly change its effect on pain ( MD-0 .4 points , 95 % CI-1 .3 to 0.4 ) or disability ( MD-0 .3 points , 95 % CI-1 .9 to 1.3 ) at four weeks .
-RESULTS	There was a small difference in favour of the experimental group for the secondary outcome of global perceived effect ( MD 1.4 points , 95 % CI 0.3 to 2.5 ) at four weeks .
-RESULTS	No significant between-group differences were observed for the other secondary outcomes .
-CONCLUSIONS	Kinesio Taping applied with stretch to generate convolutions in the skin was no more effective than simple application of the tape without tension for the outcomes measured .
-CONCLUSIONS	These results challenge the proposed mechanism of action of this therapy .
-BACKGROUND	Brazilian Registry of Clinical Trials , RBR-7ggfkv .
-
-###24599111
-OBJECTIVE	The estimation of effect size in clinical trials commonly disregards recurrent outcomes .
-OBJECTIVE	We investigated the effectiveness of a complex intervention on recurrent outcomes in patients with type 2 diabetes .
-METHODS	In the Diabetes Care in General Practice ( DCGP ) randomised controlled trial , 1,381 patients newly diagnosed with type 2 diabetes were randomised to 6 years of structured personal care or routine care ( ClinicalTrials.gov NCT01074762 ) .
-METHODS	The trial had 19 years of registry-based follow-up and was analysed with Cox regression models .
-METHODS	Repeated occurrences in the same patient of outcomes ( any diabetes-related endpoint , myocardial infarction [ MI ] , stroke , peripheral vascular disease and microvascular disease ) were accounted for with the Wei , Lin and Weissfeld method .
-RESULTS	As previously shown , the intervention reduced the rates of first occurrence of both MI and any diabetes-related endpoint .
-RESULTS	However , for all outcomes , the HR for a second event showed a statistically non-significant tendency to be increased .
-RESULTS	We estimated a combined HR for all marginal failure times , regardless of whether they were first , second or later events .
-RESULTS	This showed that the intervention had no effect on the rate of any of the outcomes , including MI ( HR 0.89 , 95 % CI 0.76 , 1.05 ) and any diabetes-related endpoint ( HR 0.98 , 95 % CI 0.87 , 1.09 ) .
-CONCLUSIONS	In the DCGP study , a smaller proportion of patients who received structured care experienced a first occurrence of MI or any diabetes-related endpoint compared with patients who received routine care .
-CONCLUSIONS	However , the patients who received structured care tended to experience more recurrent outcomes , so the total outcome rate was not affected by the intervention .
-
-###24315894
-OBJECTIVE	This study sought to report additional safety results from the ROCKET AF ( Rivaroxaban Once-daily oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ) .
-BACKGROUND	The ROCKET AF trial demonstrated similar risks of stroke/systemic embolism and major/nonmajor clinically relevant bleeding ( principal safety endpoint ) with rivaroxaban and warfarin .
-METHODS	The risk of the principal safety and component bleeding endpoints with rivaroxaban versus warfarin were compared , and factors associated with major bleeding were examined in a multivariable model .
-RESULTS	The principal safety endpoint was similar in the rivaroxaban and warfarin groups ( 14.9 vs. 14.5 events/100 patient-years ; hazard ratio : 1.03 ; 95 % confidence interval : 0.96 to 1.11 ) .
-RESULTS	Major bleeding risk increased with age , but there were no differences between treatments in each age category ( < 65 , 65 to 74,75 years ; pinteraction = 0.59 ) .
-RESULTS	Compared with those without ( n = 13,455 ) , patients with a major bleed ( n = 781 ) were more likely to be older , current/prior smokers , have prior gastrointestinal ( GI ) bleeding , mild anemia , and a lower calculated creatinine clearance and less likely to be female or have a prior stroke/transient ischemic attack .
-RESULTS	Increasing age , baseline diastolic blood pressure ( DBP ) 90 mm Hg , history of chronic obstructive pulmonary disease or GI bleeding , prior acetylsalicylic acid use , and anemia were independently associated with major bleeding risk ; female sex and DBP < 90 mm Hg were associated with a decreased risk .
-CONCLUSIONS	Rivaroxaban and warfarin had similar risk for major/nonmajor clinically relevant bleeding .
-CONCLUSIONS	Age , sex , DBP , prior GI bleeding , prior acetylsalicylic acid use , and anemia were associated with the risk of major bleeding .
-CONCLUSIONS	( An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation : NCT00403767 ) .
-
-###24423913
-OBJECTIVE	To compare the efficacy of laryngeal mask airway-Supreme ( TM ) versus common laryngeal mask airway in children with general anesthesia .
-METHODS	With local research ethics committee 's approval and written informed parental consent , 100 children were randomly divided into groups L ( size 2.0 common laryngeal mask airway ) and S ( size 2.0 laryngeal mask airway-Supreme ( TM ) ) according to random number ( n = 50 each ) .
-METHODS	After anesthesia induction , a common laryngeal mask airway or laryngeal mask airway-Supreme ( TM ) was inserted and mechanically ventilated .
-METHODS	Time and ease for insertion , insertion success rate , airway leak pressure , success rate and ease of disposal sputum collecting tube insertion in group S , quality of airway during anesthetic maintenance , abdominal circumference changes and complications within 24 h post-operation were measured .
-RESULTS	Compared with group L , abdominal circumference increased less in group S ( 0.90 0.35 vs 0.43 0.18 cm , n = 46 , P < 0.01 ) .
-RESULTS	No significant inter-group differences existed for other measurements .
-RESULTS	Disposal sputum collecting tube was successfully placed in group S ( 100 % ) .
-CONCLUSIONS	In children with mechanical ventilation , laryngeal mask airway-Supreme ( TM ) can be effectively applied to maintain a good airway .
-CONCLUSIONS	And the incidence of gastric insufflation is lower .
-CONCLUSIONS	It is particularly useful for those requiring evacuation of gastric contents during general anesthesia .
-
-###25397800
-OBJECTIVE	The purpose of this trial was to evaluate crestal bone level changes radiographically in a standardized fashion over a period of 12 months in humans for implants with a 0.7-mm machined collar ( implant type A ) versus type B implants with a 1.5-mm machined collar .
-METHODS	Twenty-five patients with multiple missing teeth in posterior sectors were randomly assigned to one of the two groups : A ( 0.7-mm machined-collar implants ) or B ( 1.5-mm machined-collar implants ) .
-METHODS	Changes at crestal bone level were assessed by measuring the shoulder-crest distance ( SCD ) on the mesial and distal aspects of each implant on customized periapical radiographs , which were taken on the day of surgery and 3 , 6 , and 12 months after surgery .
-RESULTS	Eighty-one implants were included in the study .
-RESULTS	Mean SCD was 0.54 0.53 mm at baseline and 1.49 0.40 mm after 12 months .
-RESULTS	For 0.7-mm-collar implants , mean SCD was 1.40 0.39 mm , while it was 1.56 0.40 mm for 1.5-mm-collar implants .
-RESULTS	Statistically significant differences were found only between the two types of implants for distal measurements at 3 and 12 months after placement .
-CONCLUSIONS	Both 0.7 - and 1.5-mm machined-collar implants can be used with predictable results , as changes in peri-implant crestal bone levels are similar for both implant types and do not seem to be significant from a clinical point of view .
-CONCLUSIONS	The SCD may well depend more on the location of the abutment-implant interface than on machined-collar height .
-
-###24725582
-OBJECTIVE	To explore the early childhood pulmonary outcomes of infants who participated in the National Institute of Child Health and Human Development 's Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial ( SUPPORT ) , using a factorial design that randomized extremely preterm infants to lower vs higher oxygen saturation targets and delivery room continuous positive airway pressure ( CPAP ) vs intubation/surfactant .
-METHODS	The Breathing Outcomes Study , a prospective secondary study to the Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial , assessed respiratory morbidity at 6-month intervals from hospital discharge to 18-22 months corrected age ( CA ) .
-METHODS	Two prespecified primary outcomes-wheezing more than twice per week during the worst 2-week period and cough longer than 3 days without a cold-were compared for each randomized intervention .
-RESULTS	One or more interviews were completed for 918 of the 922 eligible infants .
-RESULTS	The incidences of wheezing and cough were 47.9 % and 31.0 % , respectively , and did not differ between the study arms of either randomized intervention .
-RESULTS	Infants randomized to lower vs higher oxygen saturation targets had a similar risk of death or respiratory morbidity ( except for croup and treatment with oxygen or diuretics at home ) .
-RESULTS	Infants randomized to CPAP vs intubation/surfactant had fewer episodes of wheezing without a cold ( 28.9 % vs 36.5 % ; P < .05 ) , respiratory illnesses diagnosed by a doctor ( 47.7 % vs 55.2 % ; P < .05 ) , and physician or emergency room visits for breathing problems ( 68.0 % vs 72.9 % ; P < .05 ) by 18-22 months CA .
-CONCLUSIONS	Treatment with early CPAP rather than intubation/surfactant is associated with less respiratory morbidity by 18-22 months CA .
-CONCLUSIONS	Longitudinal assessment of pulmonary morbidity is necessary to fully evaluate the potential benefits of respiratory interventions for neonates .
-
-###24837862
-OBJECTIVE	To evaluate whether a polyethylene total body wrapping ( covering both the body and head ) is more effective than conventional treatment ( covering up to the shoulders ) in reducing perinatal thermal losses in very preterm infants .
-METHODS	This was a multicenter , prospective , randomized , parallel 1:1 , unblinded , controlled trial of infants < 29 weeks ' gestation age , comprising two study groups : experimental group ( total body group ; both the body and head covered with a polyethylene occlusive bag , with the face uncovered ) and control group ( only the body , up to the shoulders , covered with a polyethylene occlusive bag ) .
-METHODS	The primary outcome was axillary temperature on neonatal intensive care unit admission immediately after wrap removal .
-RESULTS	One hundred randomly allocated infants ( 50 in the total body group and 50 controls ) completed the study .
-RESULTS	Mean axillary temperature on neonatal intensive care unit admission was similar in the two groups ( 36.50.6 C total body vs 36.40.8 C controls ; P = .53 ) .
-RESULTS	The rate of moderate hypothermia ( temperature < 36C ) was 12 % in the total body group and 20 % in the control group ( P = .41 ) .
-RESULTS	Three subjects in each group ( 6.0 % ) had an axillary temperature > 37.5 C on admission , and one subject in control group had an axillary temperature > 38C .
-CONCLUSIONS	Total body wrapping is comparable with covering the body up to the shoulders in preventing postnatal thermal losses in very preterm infants .
-
-###24231627
-BACKGROUND	Available preclinical and phase 2 clinical data suggest that the addition of cetuximab , a monoclonal antibody directed against the epidermal growth factor receptor ( EGFR ) , to chemotherapy might improve outcome in patients with advanced non-small-cell lung cancer ( NSCLC ) .
-BACKGROUND	We aimed to assess whether the addition of cetuximab to chemotherapy improved progression-free survival in patients with recurrent or progressive NSCLC after platinum-based therapy .
-METHODS	In this unmasked , open-label randomised phase 3 trial we enrolled patients with metastatic , unresectable , or locally advanced NSCLC from 121 sites in Canada and the USA .
-METHODS	Eligible patients were those aged 18 years or older who had experienced progressive disease during or after one previous platinum-based regimen .
-METHODS	Initially , patients were randomly assigned to receive either pemetrexed ( 500 mg/m ( 2 ) ) or docetaxel ( 75 mg/m ( 2 ) ) and then randomly assigned within each group to receive their chemotherapy with or without cetuximab ( 400 mg/m ( 2 ) at first dose and 250 mg/m ( 2 ) weekly thereafter ) until disease progression or unacceptable toxicity .
-METHODS	However , after a change in the standard of care , investigators chose whether to treat with pemetrexed or docetaxel on a patient-by-patient basis .
-METHODS	The primary analysis was changed to compare progression-free survival with cetuximab plus pemetrexed versus pemetrexed , on an intention-to-treat basis .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT00095199 .
-RESULTS	Between Jan 10 , 2005 , and Feb 10 , 2010 , we enrolled 939 patients ; data for one patient was accidentally discarded .
-RESULTS	Of the remaining 938 patients , 605 received pemetrexed ( 301 patients with cetuximab and 304 alone ) and 333 received docetaxel ( 167 in combination with cetuximab and 166 alone ) .
-RESULTS	Median progression-free survival with cetuximab plus pemetrexed was 29 months ( 95 % CI 27-32 ) versus 28 months ( 25-33 ) with pemetrexed ( HR 103 , 95 % CI 087-121 ; p = 076 ) .
-RESULTS	The most common grade 3-4 adverse events with cetuximab plus pemetrexed were fatigue ( 33 [ 11 % ] of 292 patients ) , acneiform rash ( 31 [ 11 % ] ) , dyspnoea ( 29 [ 10 % ] ) , and decreased neutrophil count ( 28 [ 10 % ] ) , and with pemetrexed alone were dyspnoea ( 35 [ 12 % ] of 289 patients ) , decreased neutrophil count ( 26 [ 9 % ] ) , and fatigue ( 23 [ 8 % ] ) .
-RESULTS	A significantly higher proportion of patients in the cetuximab plus pemetrexed group ( 119 [ 41 % ] of 292 patients ) experienced at least one serious adverse event than those patients in the pemetrexed group ( 85 [ 29 % ] of 289 patients ; p = 00054 ) .
-RESULTS	Nine ( 3 % ) of 292 treated patients in the cetuximab and pemetrexed group died of adverse events compared with five ( 2 % ) of 289 treated patients in the pemetrexed alone group .
-CONCLUSIONS	The use of cetuximab is not recommended in combination with chemotherapy in patients previously treated with platinum-based therapy .
-BACKGROUND	Eli Lilly and Company and ImClone Systems LLC , a wholly owned subsidiary of Eli Lilly and Company .
-
-###25522389
-BACKGROUND	Some studies suggest better overall outcomes when right unilateral electroconvulsive therapy ( RUL ECT ) is given with an ultrabrief , rather than brief , pulse width .
-METHODS	The aim of the study was to test if ultrabrief-pulse RUL ECT results in less cognitive side effects than brief - pulse RUL ECT , when given at doses which achieve comparable efficacy .
-METHODS	One hundred and two participants were assigned to receive ultrabrief ( at 8 times seizure threshold ) or brief ( at 5 times seizure threshold ) pulse RUL ECT in a double-blind , randomized controlled trial .
-METHODS	Blinded raters assessed mood and cognitive functioning over the ECT course .
-RESULTS	Efficacy outcomes were not found to be significantly different .
-RESULTS	The ultrabrief group showed less cognitive impairment immediately after a single session of ECT , and over the treatment course ( autobiographical memory , orientation ) .
-CONCLUSIONS	In summary , when ultrabrief RUL ECT was given at a higher dosage than brief RUL ECT ( 8 versus 5 times seizure threshold ) , efficacy was comparable while cognitive impairment was less .
-
-###25245767
-BACKGROUND	We compared the effects of intravenous lidocaine ( IVL ) with lumbar epidural lidocaine analgesia ( LEA ) on pain and ileus after open colonic surgery .
-METHODS	Between December 2011 and February 2013 , 60 patients were randomly allocated to IVL , LEA , or control group .
-METHODS	The IVL group received intraoperatively lidocaine 2 % intravenously ( 1.5 mg/kg bolus , 2 mg/kg/h infusion ) and normal saline ( NS ) epidurally .
-METHODS	The LEA group received lidocaine epidurally ( 1.5 mg/kg bolus , 2 mg/kg/h infusion ) and NS intravenously .
-METHODS	The control group received NS both intravenously and epidurally , as bolus and infusion .
-METHODS	All NS volumes were calculated as if containing lidocaine 2 % at the aforementioned doses .
-METHODS	We assessed pain intensity at rest/cough at 1 , 2 , 4 , 12 , 24 , and 48 h postoperatively ( numerical rating scale 0-10 ) , 48-h analgesic consumption , and time to first flatus passage .
-RESULTS	Data from 60 patients ( 20 per group ) were analyzed .
-RESULTS	The IVL group had significantly lower pain scores at rest and cough compared to LEA or control group only at 1 , 2 , and 4 h postoperatively ( P < 0.005 for all comparisons ) .
-RESULTS	The 48-h analgesic requirements and time to first flatus passage did not differ significantly between IVL group and LEA or control group ( P > 0.05 ) .
-CONCLUSIONS	Compared with LEA-lidocaine or placebo , intravenous lidocaine offered no clinically significant benefit in terms of analgesia and bowel function .
-
-###24983434
-OBJECTIVE	To compare patient satisfaction between telemedicine and in-person follow-up appointments for orthopedic trauma .
-METHODS	Prospective randomized controlled trial ( pilot study ) .
-METHODS	Level I trauma center .
-METHODS	Twenty-four patients were enrolled and randomized into 2 groups .
-METHODS	Eight patients who had telemedicine follow-up appointments and 9 who had in-person follow-up visits were included in a per-protocol analysis .
-METHODS	In the telemedicine group , 2 patients left the study because of nonadherence , 1 patient withdrew because of a weak Internet connection , and 1 patient sustained an open fracture .
-METHODS	Three control patients left the study because of nonadherence .
-METHODS	The patients had 4 follow-up appointments during a 6-month period .
-METHODS	Patients either had their 6-week and 6-month follow-ups through video calls or in the clinic .
-METHODS	After 6-week and 6-month follow-up appointments , the patients were given survey questions that were developed using literature-supported methods to compare follow-up experiences .
-METHODS	The patients were monitored for complications .
-RESULTS	There was no significant difference in patient satisfaction between telemedicine and in-person clinic visits ( telemedicine : 89 % satisfied ; control : 100 % satisfied ; P = 0.74 ) .
-RESULTS	Zero percent of patients in the telemedicine group took time off their work for their appointment compared with 55.6 % in the control ( P = 0.03 ) .
-RESULTS	Telemedicine patients spent significantly less time on their visits ( P = 0.01 ) .
-RESULTS	The majority of the patients in the telemedicine group reported clear visual ( 87.5 % ) and sound quality ( 100 % ) through and agreed to future follow-up visits through telemedicine ( 75.0 % ) .
-RESULTS	One patient in each group developed complications .
-CONCLUSIONS	Telemedicine may be a viable alternative to some in-person clinic visits because of similar measures of patient satisfaction but with significantly less time and distance traveled .
-METHODS	Therapeutic level II .
-METHODS	See Instructions for authors for a complete description of levels of evidence .
-
-###25179493
-BACKGROUND	Chronic hepatitis B ( CHB ) is a major public health concern , particularly in endemic areas like Asia-Pacific .
-BACKGROUND	Sustained virologic suppression correlates with regression of histologic fibrosis and cirrhosis .
-OBJECTIVE	This study evaluated efficacy and safety of tenofovir disoproxil fumarate ( TDF ) in Asian patients through 240 weeks of treatment .
-METHODS	Post hoc analysis of the Asian subpopulation from two phase 3 clinical studies was performed .
-METHODS	Following a 48-week randomized , double-blind evaluation of once-daily TDF versus once-daily adefovir dipivoxil , open-label TDF for up to 240 weeks was evaluated .
-METHODS	Patients with both baseline and week 240 liver biopsies were evaluated for histologic changes .
-RESULTS	At baseline , 189/641 ( 29 % ) patients randomized were Asian .
-RESULTS	Sixty-eight percent of Asian patients were male ; 50 % were hepatitis B e antigen ( HBeAg ) - positive .
-RESULTS	At week 240 , similar proportions of Asian ( 88 % ) and non-Asian ( 87 % ) patients demonstrated improvement in liver histology , and 19/22 ( 86 % ) Asian patients with baseline cirrhosis were no longer cirrhotic .
-RESULTS	By modified intent-to-treat analysis , 74 % of Asian patients and 76 % of non-Asian patients had HBV DNA < 400 copies/mL at the end of week 240 ( P = 0.602 ) .
-RESULTS	No differences were seen in HBeAg loss or seroconversion in Asian versus non-Asian patients .
-RESULTS	No Asian patient experienced hepatitis B surface antigen loss .
-RESULTS	Safety and tolerability of TDF through week 240 , including changes in renal function and in hip/spine bone mineral density ( from weeks 192 to 240 ) , were comparable between Asian and non-Asian patients .
-CONCLUSIONS	Long-term virologic and histologic efficacy and safety of TDF are comparable in Asian and non-Asian CHB patients .
-
-###24909093
-OBJECTIVE	To study the effect of exogenous i.m. glucagon on recovery from controlled insulin-induced hypoglycaemia in patients with type 2 diabetes treated with the novel glucokinase activator AZD1656 , in combination with metformin .
-METHODS	This was a single-centre randomized , open , two-way crossover phase I , automated glucose clamp ( Biostator ( ) ; Life Science Instruments , Elkhart , MD , USA ) study ( NCT00817271 ) in eight patients ( seven men and one woman , mean age 58.6 years , body mass index 28.1 kg/m ( 2 ) ) .
-METHODS	All patients received a stable dose of metformin twice daily , ranging from 1000 to 2250 mg .
-METHODS	A 2-day titration phase commenced with 40 mg AZD1656 twice daily , escalating to 80 mg twice daily if tolerated .
-METHODS	This was followed by a single dose of 80 or 160 mg AZD1656 , administered on days 5 and 8 when metabolic studies were performed .
-METHODS	After an overnight fast on days 5 and 8 , controlled hypoglycaemia was induced using an exogenous i.v. infusion of insulin .
-METHODS	Plasma glucose was lowered in a stepwise fashion over 3 h to attain a target nadir of 2.7 mmol/l .
-METHODS	This was sustained for 30 min , at the end of which the hypoglycaemic clamp was released .
-METHODS	In random sequence , patients either received an i.m. injection of 1 mg glucagon or were allowed to recover from hypoglycaemia by endogenous counter-regulation .
-METHODS	To avoid prolonged hypoglycaemia , a reverse glucose clamp was applied from 4 to 6 h post-dose .
-RESULTS	Three patients received 40 mg AZD1656 twice daily and five patients 80 mg twice daily .
-RESULTS	Mean plasma glucose at 20 min after release of the hypoglycaemic clamp was significantly lower ( 3.1 0.3 mmol/l ) for AZD1656 alone than for AZD1656 + glucagon ( 4.9 0.8 mmol/l ; p < 0.001 between the groups ) .
-RESULTS	Catecholamine and cortisol responses were similar on the AZD1656 + glucagon and AZD alone study days .
-RESULTS	Growth hormone response was 18 % lower for AZD1656 alone ( p = 0.01 ) , consistent with the effect of a pharmacological dose of glucagon on growth hormone secretion .
-RESULTS	No safety or tolerability concerns were observed during treatment with AZ1656 .
-CONCLUSIONS	Exogenous glucagon was effective as a rescue treatment for hypoglycaemia induced during treatment with AZD1656 , given in combination with metformin in patients with type 2 diabetes .
-
-###25358059
-OBJECTIVE	Retrograde intrarenal surgery ( RIRS ) involves a minimally invasive stone surgery , lending itself potential to combined spinal-epidural anesthesia ( CSEA ) , although it is performed preferably under general anesthesia ( GA ) .
-OBJECTIVE	This prospective randomized study was undertaken to evaluate the feasibility and efficacy of CSEA for patients undergoing RIRS .
-METHODS	Seventy consecutive patients who were scheduled for RIRS were randomized to receive CSEA ( n = 35 ) or GA ( n = 35 ) .
-METHODS	Operative time , stone clearance rate , visual analog scale ( VAS ) of pain , complication rate , anesthetic cost , and hospital stay were compared between the two groups .
-RESULTS	A total of 65 patients randomized to CSEA ( 31 ) or GA ( 34 ) completed the study .
-RESULTS	In the CSEA group , each procedure was completed and there was no anesthetic conversion .
-RESULTS	Although based on the prospective randomized method , the GA group still had a little larger stone size ( p = 0.059 ) and more multiple caliceal stones ( p = 0.037 ) .
-RESULTS	Overall , there were no statistically significant differences in operative time ( p = 0.088 ) , stone fragmentation time ( p = 0.074 ) , postoperative VAS pain score at 6 and 24 hours ( p = 0.156 , 0.146 ) , incidence of complications ( p = 0.870 ) , stone-free rate ( p = 0.804 ) , and hospital stays ( p = 0.907 ) between the two groups .
-RESULTS	The patients in the GA group experienced a higher mean hemoglobin drop ( 6.53.2 vs 8.62.7 g/L , p = 0.012 ) .
-RESULTS	In addition , the anesthetic cost was much cheaper in the CSEA group ( 183.831.4 vs 391.959.1 dollars , p < 0.001 ) .
-CONCLUSIONS	RIRS with CSEA can be completed with no anesthetic conversions and with the same efficacy and safety compared with GA. .
-CONCLUSIONS	When considering economical aspects , CSEA appears to be a preferable alternative to GA for the patient whose general health status permits it .
-
-###24465425
-BACKGROUND	Progesterone is effective treatment for hot flushes/night sweats .
-BACKGROUND	The cardiovascular effects of progesterone therapy are unknown but evidence suggests that premenopausal normal estradiol with also normal progesterone levels may provide later cardiovascular protection .
-BACKGROUND	We compared the effects of progesterone to placebo on endothelial function , weight , blood pressure , metabolism , lipids , inflammation and coagulation .
-RESULTS	We conducted a randomized , double-blind , 3-month placebo-controlled trial of progesterone ( 300 mg daily ) among 133 healthy postmenopausal women in Vancouver , Canada from 2003-2009 .
-RESULTS	Endothelial function by venous occlusion plethysmography was a planned primary outcome .
-RESULTS	Enrolled women were 1-11 y since last menstruation , not using hormones ( for > 6 months ) , non-smoking , without diabetes , hypertension , heart disease or their medications .
-RESULTS	Randomized ( 11 ) women ( 55 4 years , body mass index 25 3 ) initially had normal blood pressure , fasting lipid , glucose and electrocardiogram results .
-RESULTS	Endothelial function ( % forearm blood flow above saline ) was not changed with progesterone ( 487 189 % , n = 18 ) compared with placebo ( 408 278 % , n = 16 ) ( 95 % CI diff [ -74 to 232 ] , P = 0.30 ) .
-RESULTS	Progesterone ( n = 65 ) and placebo ( n = 47 ) groups had similar changes in systolic and diastolic blood pressure , resting heart rate , weight , body mass index , waist circumference , total cholesterol , low-density lipoprotein cholesterol and triglyceride levels .
-RESULTS	High-density lipoprotein was lower ( -0.14 mmol/L , P = 0.001 ) on progesterone compared with placebo .
-RESULTS	Fasting glucose , hs-C-reactive protein , albumin and D-dimer changes were all comparable to placebo .
-RESULTS	Framingham General Cardiovascular Risk Profile scores were initially low and remained low with progesterone therapy and not statistically different from placebo .
-CONCLUSIONS	Results indicate that progesterone has short-term cardiovascular safety .
-CONCLUSIONS	Endothelial function , weight , blood pressure , waist circumference , inflammation and coagulation were unchanged as were lipids except for HDL-C .
-CONCLUSIONS	The statistically significant decrease in HDL-C levels was not clinically important ( based on lack of Cardiovascular Risk Profile change ) .
-BACKGROUND	ClinicalTrials.gov NCT00152438 .
-
-###25315498
-BACKGROUND	Fluralaner ( Bravecto ; Merck/MSD Animal Health ) is a novel systemic ectoparasiticide for dogs providing long-acting flea and tick control after a single oral dose .
-BACKGROUND	Milbemycin oxime and praziquantel are routinely used to control Dirofilaria immitis and intestinal worm infections in dogs .
-BACKGROUND	The safety of concurrent use of fluralaner and a commercially available milbemycin oxime plus praziquantel combination tablet , in particular with regard to gastrointestinal symptoms , was investigated using oral doses at or above the maximum recommended rates .
-RESULTS	Some minor and transient clinical findings were observed during the study period ; however , none of these was considered to be related to concurrent treatment with fluralaner and milbemycin oxime plus praziquantel , or to the use of either product alone .
-CONCLUSIONS	Concurrent treatment with fluralaner , milbemycin oxime and praziquantel is well tolerated in dogs .
-
-###24941286
-OBJECTIVE	Afterschool programs can be health-promoting environments for children .
-OBJECTIVE	Written policies positively influence nutrition and physical activity ( PA ) environments , but effective strategies for building staff capacity to write such policies have not been evaluated .
-OBJECTIVE	This study measures the comprehensiveness of written nutrition , PA , and screen time policies in afterschool programs and assesses impact of the Out of School Nutrition and Physical Activity ( OSNAP ) intervention on key policies .
-METHODS	Twenty afterschool programs in Boston , MA participated in a group-randomized , controlled trial from September 2010 to June 2011 .
-METHODS	Intervention program staff attended learning collaboratives focused on practice and policy change .
-METHODS	The Out-of-School Time ( OST ) Policy Assessment Index evaluated written policies .
-METHODS	Inter-rater reliability and construct validity of the measure and impact of the intervention on written policies were assessed .
-RESULTS	The measure demonstrated moderate to excellent inter-rater reliability ( Spearman 's r = 0.53 to 0.97 ) and construct validity .
-RESULTS	OSNAP was associated with significant increases in standards-based policy statements surrounding snacks ( +2.6 , p = 0.003 ) , beverages ( +2.3 , p = 0.008 ) , screen time ( +0.8 , p = 0.046 ) , family communication ( +2.2 , p = 0.002 ) , and a summary index of OSNAP goals ( +3.3 , p = 0.02 ) .
-CONCLUSIONS	OSNAP demonstrated success in building staff capacity to write health-promoting policy statements .
-CONCLUSIONS	Future research should focus on determining policy change impact on practices .
-
-###24424074
-OBJECTIVE	Nut consumption has been found to decrease risk of coronary heart disease and diabetes and to promote healthy body weights possibly related to their favorable macronutrient profile .
-OBJECTIVE	We therefore assessed the effect of pistachios on postprandial glucose and insulin levels , gut hormones related to satiety and endothelial function .
-METHODS	In this randomized crossover study , 20 subjects with metabolic syndrome consumed five study meals over 5-10 weeks .
-METHODS	The meals differed in fat type and quantity , but were matched according to available carbohydrates ( CHOs ) .
-METHODS	Three meals had 50 g available CHO : white bread ( WB50g ) , white bread , butter and cheese ( WB+B+C h ) and white bread and pistachios ( WB+P ) .
-METHODS	Two meals had 12 g available CHO : white bread ( WB12g ) and pistachios ( P ) .
-RESULTS	Within each group of available CHO meals , postprandial glucose levels were the highest following the white bread-only meals , and glucose response was significantly attenuated when butter and cheese or pistachios were consumed ( P < 0.05 ) .
-RESULTS	Postprandial insulin levels were highest after the WB+B+C h meal ( P < 0.05 ) , but did not differ between the white bread-only and pistachio meals .
-RESULTS	Both endothelial function ( reactive hyperemia index ) and arterial stiffness ( augmentation index ) significantly increased after the white bread-only meals compared with the WB+B+C h meal ( all P < 0.05 ) .
-RESULTS	Insulin secretagogue levels were higher when butter and cheese or pistachios were consumed than when white bread only was consumed ( P < 0.05 ) .
-CONCLUSIONS	Compared with white bread , pistachio consumption reduced postprandial glycemia , increased glucagon-like-peptide levels and may have insulin-sparing properties .
-CONCLUSIONS	These effects could be beneficial for individuals with diabetes and metabolic syndrome .
-
-###26125443
-BACKGROUND	Bevacizumab prolongs progression-free survival ( PFS ) in patients with metastatic colorectal cancer .
-BACKGROUND	We analysed the protein expression levels of vascular endothelial growth factor ( VEGF ) ligands and receptors to determine their prognostic and predictive effects .
-METHODS	We graded expression of VEGF-A , VEGF-B , VEGF-C , VEGF-D , VEGF-R1 , and VEGF-R2 to assess whether overexpression predicted bevacizumab resistance in samples from 268 of 471 patients randomised to capecitabine ( C ) , capecitabine and bevacizumab ( CB ) , or CB and mitomycin ( CBM ) in the MAX trial and extended the analysis to the CAIRO-2 population .
-RESULTS	Patients with low expression of VEGF-D ( 0 , 1 ) benefited from bevacizumab treatment ( PFS hazard ratio ( HR ) ( C vs CBCBM ) , 0.21 ; 95 % CI , 0.080.55 ; overall survival ( OS ) HR , 0.35 ; 95 % CI , 0.130.90 ) .
-RESULTS	Patients with higher VEGF-D expression received less benefit ( VEGF-D 2 PFS HR , 0.67 ; 95 % CI , 0.451.00 ; OS HR , 0.82 ; 95 % CI , 0.521.30 ; VEGF-D 3 PFS HR , 0.77 ; 95 % CI , 0.501.17 ; OS HR , 1.28 ; 95 % CI , 0.792.09 ) ( P interaction o0 .05 ) .
-RESULTS	In CAIRO-2 , there was no difference in PFS or OS according to VEGF-D expression .
-CONCLUSIONS	The predictive value of VEGF-D expression for bevacizumab may depend on the chemotherapy backbone used .
-CONCLUSIONS	Further evaluation is required before clinical utilisation .
-
-###25122186
-BACKGROUND	Abnormalities in cardiac structure and function in heart failure with preserved ejection fraction may help identify patients at particularly high risk for cardiovascular morbidity and mortality .
-RESULTS	Cardiac structure and function were assessed by echocardiography in a blinded core laboratory at baseline in 935 patients with heart failure with preserved ejection fraction ( left ventricular ejection fraction 45 % ) enrolled in the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist ( TOPCAT ) trial and related to the primary composite outcome of cardiovascular death , heart failure hospitalization , or aborted cardiac arrest , and its components .
-RESULTS	At a median follow-up of 2.9 years , 244 patients experienced the primary outcome .
-RESULTS	Left ventricular hypertrophy ( adjusted hazard ratio , 1.52 ; 95 % confidence interval , 1.16-2 .00 ) , elevated left ventricular filling pressure ( E/E ' ; adjusted hazard ratio 1.05 per 1 integer increase ; 95 % confidence interval , 1.02-1 .07 ) , and higher pulmonary artery pressure assessed by the tricuspid regurgitation velocity ( hazard ratio , 1.23 per 0.5 m/s increase ; 95 % confidence interval , 1.02-1 .49 ) were associated with the composite outcome and heart failure hospitalization alone after adjusting for clinical and laboratory variables .
-RESULTS	The risk of adverse outcome associated with left ventricular hypertrophy was additive to the risk associated with elevated E/E ' .
-CONCLUSIONS	Among heart failure with preserved ejection fraction patients enrolled in TOPCAT , left ventricular hypertrophy , higher left ventricular filling pressure , and higher pulmonary artery pressure were predictive of heart failure hospitalization , cardiovascular death , or aborted cardiac arrest independent of clinical and laboratory predictors .
-CONCLUSIONS	These features , both alone and in combination , identify heart failure with preserved ejection fraction patients at particularly high risk for cardiovascular morbidity and mortality .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00094302 .
-
-###25376940
-BACKGROUND	The clinical benefits of bioimpedance spectroscopy ( BIS ) - guided fluid management in patients on hemodialysis have been widely demonstrated .
-BACKGROUND	However , no previous reports have evaluated the effect of regular and serial BIS-guided fluid management on the residual renal function ( RRF ) in patients on peritoneal dialysis ( PD ) .
-BACKGROUND	Therefore , we will evaluate the clinical efficacy of BIS-guided fluid management for preserving RRF and protecting cardiovascular events in patients on PD .
-METHODS	This is a multicenter , prospective , randomized controlled trial .
-METHODS	A total of 138 participants on PD will be enrolled and randomly assigned to receive either BIS-guided fluid management or fluid management based only on the clinical information for 1 year .
-METHODS	The primary outcome is the change in the glomerular filtration rate ( GFR ) between months 0 and 12 after starting treatment .
-METHODS	The secondary outcomes will include GFR at month 12 , time to the anuric state ( urine volume < 100 ml/day ) , and fatal and nonfatal cardiovascular events during treatment .
-CONCLUSIONS	This is the first clinical trial to investigate the effect of BIS-guided fluid management on RRF and for protecting against cardiovascular events in patients on PD .
-BACKGROUND	Clinical Trials.gov number NCT01887262 , June 24 , 2013 .
-
-###24307845
-OBJECTIVE	This study was performed to compare the mucosal findings after esophagogastroduodenoscopy in two groups before and after the use of alendronate only and following administration of the enteric-coated alendronate ( 5 mg ) and calcitriol ( 0.5 g ) combined drug ( Maxmarvil , Yuyu Co. ) .
-METHODS	The study population consisted of 33 postmenopausal healthy female volunteers , aged 50 to 70 years ( mean age , 58 5 ) without gastrointestinal symptoms and with normal baseline endoscopic findings .
-METHODS	Esophagogastroduodenoscopy was performed at baseline and was repeated 2 weeks later after daily intake of Maxmarvil ( n = 17 subjects ) or alendronate only ( n = 16 subjects ) .
-METHODS	Mucosal injury scores were reported by an endoscopist after 2 weeks of treatment with each medication schedule .
-RESULTS	Esophageal mucosal injuries developed in two of 16 subjects in the alendronate only group and 0 of 17 in the Maxmarvil group .
-RESULTS	Gastric mucosal injuries developed in eight subjects in the alendronate group and four subjects in the Maxmarvil group ; this difference was statistically significant .
-CONCLUSIONS	The mucosal damage scores for the alendronate group ( total score 24 ) were significantly higher than those for the Maxmarvil group ( total score 9 ) in the esophagus and stomach .
-CONCLUSIONS	Therefore , this study suggested that enteric-coated Maxmarvil is less harmful to gastrointestinal mucosa than alendronate , and may improve the tolerability of osteoporosis medication in clinical practice .
-
-###24723432
-OBJECTIVE	Although antidepressant drugs are used as first-line intervention to treat patients with generalized anxiety disorder ( GAD ) , only one-third of patients respond positively to treatment .
-OBJECTIVE	In our study , we investigated whether functional genetic polymorphisms in the dopamine active transporter 1 ( DAT1 ) and dopamine receptor D2 ( DRD2 ) may play a role in antidepressant treatment response in GAD .
-METHODS	We examined 156 patients diagnosed with GAD who received venlafaxine Extended-Release ( XR ) treatment as part of an 18-month relapse-prevention study to determine whether variation in these genes had an effect on treatment response after 6months of open-label treatment .
-METHODS	Genotypes were obtained for rs1076560 ( DRD2 ) , rs1800497 ( DRD2 ) , rs2550948 ( DAT1 ) , and a variable number tandem repeat in the 3 ' untranslated region of the DAT1 gene using standard methods .
-RESULTS	Results show that none of the tested variants were associated with treatment response to venlafaxine XR in GAD .
-RESULTS	Genotype and allele frequencies did not differ statistically significantly between responders and non-responders using either the Hamilton Anxiety or Clinical Global Impressions of Improvement Scale at 6months .
-CONCLUSIONS	Although we detected no association in our sample , future studies using larger samples and more comprehensive gene coverage are needed to evaluate potential effects of dopaminergic variants on antidepressant treatment response in anxiety disorders .
-
-###24419415
-BACKGROUND	In non-small-cell lung cancer , an exon 19 deletion and an L858R point mutation in the epidermal growth factor receptor ( EGFR ) are predictors of a response to EGFR-tyrosine kinase inhibitors .
-BACKGROUND	However , it is uncertain whether other uncommon EGFR mutations are associated with sensitivity to EGFR-tyrosine kinase inhibitors .
-METHODS	A post-hoc analysis to assess prognostic factors was performed with the use of patients with EGFR mutations ( exon 19 deletion , L858R , G719X , and L861Q ) who were treated with gefitinib in the NEJ002 study , which compared gefitinib with carboplatin-paclitaxel as the first-line therapy .
-RESULTS	In the NEJ002 study , 225 patients with EGFR mutations received gefitinib at any treatment line .
-RESULTS	The Cox proportional hazards model indicated that performance status , response to chemotherapy , response to gefitinib , and mutation types were significant prognostic factors .
-RESULTS	Overall survival ( OS ) was significantly shorter among patients with uncommon EGFR mutations ( G719X or L861Q ) compared with OS of those with common EGFR mutations ( 12 versus 28.4 months ; p = 0.002 ) .
-RESULTS	In the gefitinib group ( n = 114 ) , patients with uncommon EGFR mutations had a significantly shorter OS ( 11.9 versus 29.3 months ; p < 0.001 ) .
-RESULTS	By contrast , OS was similar between patients with uncommon mutations and those with common mutations in the carboplatin-paclitaxel group ( n = 111 ; 22.8 versus 28 months ; p = 0.358 ) .
-CONCLUSIONS	The post-hoc analyses clearly demonstrated shorter survival for gefitinib-treated patients with uncommon EGFR mutations compared with the survival of those with common mutations and suggest that the first-line chemotherapy may be relatively effective for non-small-cell lung cancer with uncommon EGFR mutations .
-
-###24628999
-OBJECTIVE	To compare refractive changes after corneal crosslinking with and without mechanical compression of the cornea .
-METHODS	In a prospective , open , randomized case-control study conducted at the Department of Ophthalmology , Ume University Hospital , Sweden , sixty eyes of 43 patients with progressive keratoconus aged 18-28 years planned for corneal crosslinking and corresponding age - and sex-matched control subjects were included .
-METHODS	The patients were randomized to conventional corneal crosslinking ( CXL ; n = 30 ) or corneal crosslinking with mechanical compression using a flat rigid contact lens sutured to the cornea during treatment ( CRXL ; n = 30 ) .
-METHODS	Subjective refraction and ETDRS best spectacle-corrected visual acuity ( BSCVA ) , axial length measurement , keratometry and pachymetry were performed before and 1 and 6 months after treatment .
-RESULTS	The keratoconus patients had poorer BSCVA , higher refractive astigmatism and higher keratometry readings than the control subjects at baseline ( p < 0.01 ) .
-RESULTS	In the CXL group , BSCVA increased from 0.19 0.26 to 0.14 0.18 logMar ( p = 0.03 ) , and the spherical equivalent improved from -1.9 2.8 D to -1.4 2.4 D ( p = 0.03 ) .
-RESULTS	Maximum keratometry readings decreased after CXL from 53.1 4.9 D to 52.6 5.2 D ( p = 0.02 ) , and the axial length decreased in the CXL group , likely due to post-treatment corneal thinning ( p = 0.03 ) .
-RESULTS	In the CRXL group , all the above variables were unaltered ( p > 0.05 ) .
-CONCLUSIONS	At 6 months , the refractive results from CRXL did not surpass those of conventional CXL treatment .
-CONCLUSIONS	Rather , some variables indicated a slightly inferior effect .
-CONCLUSIONS	Possibly , stronger crosslinking would be necessary to stabilize the cornea in the flattened configuration achieved by the rigid contact lens .
-
-###24841107
-BACKGROUND	Although coexisting obstructive sleep apnea ( OSA ) and Cheyne-Stokes respiration ( CSR ) occur frequently in patients with heart diseases , optimal treatment remains unclear .
-BACKGROUND	Positive airway pressure ( PAP ) effectively treats OSA and adaptive servo-ventilation ( ASV ) has been shown to improve CSR .
-BACKGROUND	We compared a new treatment algorithm combining automatic continuous positive airway pressure ( APAP ) and ASV ( anticyclic modulated ventilation , ACMV ) versus continuous positive airway pressure ( CPAP ) .
-METHODS	Thirty-nine patients ( 35 male , four female ; aged 65.59.7 years ; body mass index , 31.05.9 kg/m2 ) with underlying heart disease and coexisting OSA and CSR were enrolled .
-METHODS	After diagnostic polysomnography ( PSG ) and CPAP titration , patients were randomized either to CPAP or to ACMV for four weeks of treatment in a crossover design .
-RESULTS	Total apnea-hypopnea index ( AHI ) was 49.018.8 / h at baseline , 12.314.6 / h with CPAP ( P < 0.001 vs baseline ) , and 3.75.6 / h with ACMV ( P < 0.001 vs. baseline and vs. CPAP ) .
-RESULTS	Obstructive AHI was 20.714.4 / h at baseline , 5.19.3 / h with CPAP ( P < 0.001 vs. baseline ) , and 0.40.4 / h with ACMV ( P < 0.001 vs. baseline and vs. CPAP ) .
-RESULTS	Central AHI was 28.313.4 / h at baseline , 7.29.7 / h with CPAP ( P < 0.001 vs baseline ) and 3.35.4 / h with ACMV ( P < 0.001 vs. baseline and vs. CPAP ) .
-RESULTS	Ejection fraction was increased significantly ( from 38.615.6 to 44.412.2 % ) only with ACMV .
-RESULTS	Subjective sleepiness significantly improved only with CPAP whereas objective sleep quality and treatment adherence were not different between both treatment modalities .
-CONCLUSIONS	ACMV is an effective treatment option in patients with coexisting OSA and CSR .
-CONCLUSIONS	It is superior to CPAP in reducing total AHI as well as obstructive and central AHI .
-
-###25098819
-BACKGROUND	HER2 and TOP2A gene status are assessed for diagnostic and research purposes in breast cancer with fluorescence in situ hybridization ( FISH ) .
-BACKGROUND	However , FISH probes do not target only the annotated gene , while chromosome 17 ( chr17 ) is among the most unstable chromosomes in breast cancer .
-BACKGROUND	Here we asked whether the status of specifically targeted genes on chr17 might help in refining prognosis of early high-risk breast cancer patients .
-METHODS	Copy numbers ( CN ) for 14 genes on chr17 , 4 of which were within and 10 outside the core HER2 amplicon ( HER2 - and non-HER2-genes , respectively ) were assessed with qPCR in 485 paraffin-embedded tumor tissue samples from breast cancer patients treated with adjuvant chemotherapy in the frame of two randomized phase III trials .
-RESULTS	HER2-genes CN strongly correlated to each other ( Spearman 's rho > 0.6 ) and were concordant with FISH HER2 status ( Kappa 0.6697 for ERBB2 CN ) .
-RESULTS	TOP2A CN were not concordant with TOP2A FISH status ( Kappa 0.1154 ) .
-RESULTS	CN hierarchical clustering revealed distinct patterns of gains , losses and complex alterations in HER2 - and non-HER2-genes associated with IHC4 breast cancer subtypes .
-RESULTS	Upon multivariate analysis , non-HER2-gene gains independently predicted for shorter disease-free survival ( DFS ) and overall survival ( OS ) in patients with triple-negative cancer , as compared to luminal and HER2-positive tumors ( interaction p = 0.007 for DFS and p = 0.011 for OS ) .
-RESULTS	Similarly , non-HER2-gene gains were associated with worse prognosis in patients who had undergone breast-conserving surgery as compared to modified radical mastectomy ( p = 0.004 for both DFS and OS ) .
-RESULTS	Non-HER2-gene losses were unfavorable prognosticators in patients with 1-3 metastatic nodes , as compared to those with 4 or more nodes ( p = 0.017 for DFS and p = 0.001 for OS ) .
-CONCLUSIONS	TOP2A FISH and qPCR may not identify the same pathology on chr17q .
-CONCLUSIONS	Non-HER2 chr17 CN patterns may further predict outcome in breast cancer patients with known favorable and unfavorable prognosis .
-
-###24225201
-BACKGROUND	Heart failure ( HF ) and chronic obstructive pulmonary disease ( COPD ) frequently coexist , with undefined prognostic and therapeutic implications .
-BACKGROUND	We investigated clinical profile and outcomes of patients with chronic HF and COPD , notably the efficacy and safety of ivabradine , a heart rate-reducing agent .
-METHODS	6505 ambulatory patients , in sinus rhythm , heart rate 70 bpm and stable systolic HF were randomised to placebo or ivabradine ( 2.5 to 7.5 mg bid ) .
-METHODS	Multivariate Cox model analyses were performed to compare the COPD ( n = 730 ) and non-COPD subgroups , and the ivabradine and placebo treatment effects .
-RESULTS	COPD patients were older and had a poorer risk profile .
-RESULTS	Beta-blockers were prescribed to 69 % of COPD patients and 92 % of non-COPD patients .
-RESULTS	The primary endpoint ( PEP ) and its component , hospitalisation for worsening HF , were more frequent in COPD patients ( HRs f , 1.22 [ p = 0.006 ] ; and 1.34 [ p < 0.001 ] ) respectively , but relative risk was reduced similarly by ivabradine in both COPD ( 14 % , and 17 % ) and non-COPD ( 18 % and 27 % ) patients ( p interaction = 0.82 , and 0.53 , respectively ) .
-RESULTS	Similar effect was noted also for cardiovascular death .
-RESULTS	Adverse events were more common in COPD patients , but similar in treatment subgroups .
-RESULTS	Bradycardia occurred more frequently in ivabradine subgroups , with similar incidence in patients with or without COPD .
-CONCLUSIONS	The association of COPD and HF results in a worse prognosis , and COPD represents a barrier to optimisation of beta-blocker therapy .
-CONCLUSIONS	Ivabradine is similarly effective and safe in chronic HF patients with or without COPD , and can be safely combined with beta-blockers in COPD .
-
-###24590419
-OBJECTIVE	Although several eating disorder prevention programs reduce eating disorder risk factors and symptoms for female high school and college students , few efficacious prevention programs exist for female middle school students , despite the fact that body image and eating disturbances often emerge then .
-OBJECTIVE	Two pilot trials evaluated a new dissonance-based eating disorder prevention program for middle school girls with body image concerns .
-METHODS	Female middle school students with body dissatisfaction from two sites [ Study 1 : N = 81 , M age = 12.1 , standard deviation ( SD ) = 0.9 ; Study 2 : N = 52 , M age = 12.5 , SD = 0.8 ] were randomized to a dissonance intervention ( MS Body Project ) or educational brochure control ; Study 2 included a 3-month follow-up .
-RESULTS	Intervention participants showed significant post-test reductions in only one of the six variables with both Studies 1 and 2 ( i.e. , pressure to be thin and negative affect , respectively ) , though post-test effect sizes suggested medium reductions in eating disorder risk factors and symptoms ( Study 1 : M d = .40 ; Study 2 : M d = .65 ) ; reductions at 3-month follow-up in Study 2 were not evident ( M d = .19 ) .
-CONCLUSIONS	Results suggest that this new middle school version of the Body Project is producing medium magnitude reductions in eating disorder risk factors at post-test but that effects are showing limited persistence .
-CONCLUSIONS	Continued refinement and evaluation of this intervention appears warranted to develop more effective prevention programs for this age group .
-
-###24809408
-OBJECTIVE	The aim of this study is to evaluate the effect of oral glutamine ( GL ) supplementation on gut permeability and endotoxemia ( surrogate end point ) in patients with severe acute pancreatitis .
-METHODS	In a randomized controlled trial , patients were randomized to be given placebo or GL for 7 days .
-METHODS	The primary outcome measures include the effect on gut permeability ( assessed by lactulose/mannitol excretion in urine and endotoxemia assessed by endotoxin core antibodies type IgG and IgM ( EndoCab IgG and IgM ) .
-METHODS	The secondary outcome measures include infectious complications , mortality , total hospital/intensive care unit stay , C-reactive protein , and prealbumin levels .
-RESULTS	Patients were assigned to GL ( n = 41 ) and placebo ( n = 39 ) groups .
-RESULTS	There was no change in gut permeability after the intervention .
-RESULTS	However , the EndoCab IgM levels increased significantly ( 33 [ 4 , 175 ] to 40 [ 8 , 350 ] GMU/mL ; P = 0.0164 ) and the C-reactive protein levels decreased significantly ( 133 [ 1 , 287 ] to 88 [ 1 , 267 ] ng/mL ; P = 0.0236 ) in the GL group .
-RESULTS	No difference was observed in infectious complication , prealbumin value , hospital/intensive care unit stay , and mortality in both groups .
-CONCLUSIONS	No significant trend was identified for an effect of GL on gut permeability .
-CONCLUSIONS	Decreased inflammation and endotoxemia did not translate into reduced infectious complications in severe acute pancreatitis .
-CONCLUSIONS	However , the study was underpowered to detect the aforementioned difference ( trial registration : CTRI/2009/000945 ) .
-
-###24713310
-BACKGROUND	Tapentadol is an analgesic agent for treatment of acute and chronic pain that activates the - opioid receptor combined with inhibition of neuronal norepinephrine reuptake .
-BACKGROUND	Both mechanisms are implicated in activation of descending inhibitory pain pathways .
-BACKGROUND	In this study , we investigated the influence of tapentadol on conditioned pain modulation ( CPM , an experimental measure of endogenous pain inhibition that gates incoming pain signals as a consequence of a preceding tonic painful stimulus ) and offset analgesia ( OA , a test in which a disproportionally large amount of analgesia becomes apparent upon a slight decrease in noxious heat stimulation ) .
-METHODS	Twenty-four patients with diabetic polyneuropathy ( DPN ) were randomized to receive daily treatment with tapentadol sustained-release ( SR ) [ average daily dose 433 ( 31 ) mg ] or placebo for 4 weeks .
-METHODS	CPM and OA were measured before and on the last day of treatment .
-RESULTS	Before treatment , none of the patients had significant CPM or OA responses .
-RESULTS	At week 4 of treatment , CPM was significantly activated by tapentadol SR and coincided with significant analgesic responses .
-RESULTS	CPM increased from 9.1 ( 5.4 ) % ( baseline ) to 14.3 ( 7.2 ) % ( placebo ) and 24.2 ( 7.7 ) % ( tapentadol SR , P < 0.001 vs placebo ) ; relief of DPN pain was also greater in patients treated with tapentadol than placebo ( P = 0.028 ) .
-RESULTS	Neither placebo nor tapentadol SR treatment had an effect on the magnitude of the OA responses ( P = 0.78 ) .
-CONCLUSIONS	Tapentadol 's analgesic effect in chronic pain patients with DPN is dependent on activation of descending inhibitory pain pathways as observed by CPM responses .
-BACKGROUND	The study was registered at trialregister.nl under number NTR2716 .
-
-###24548981
-OBJECTIVE	To characterize the safety , tolerability , pharmacokinetics ( PK ) and dose proportionality of mipomersen after single subcutaneous ( SC ) administration to Japanese healthy subjects ; and to compare the PK profiles of Japanese and Western subjects .
-METHODS	20 healthy first-generation Japanese male subjects were enrolled into one of three treatment cohorts ( 50 , 100 and 200 mg SC ) in a dose-escalation design .
-METHODS	Within each cohort , subjects were randomized in a 4 : 1 ratio to receive mipomersen or placebo .
-RESULTS	Mipomersen was absorbed rapidly after SC administration ; median tmax varied between 2 and 3 hours .
-RESULTS	After reaching peak levels , plasma concentrations of mipomersen decayed multiphasically with an initial distribution t1/2 in several hours and a terminal t1/2 of 261 - 393 hours .
-RESULTS	Mean Cmax increased in a dose-linear manner while all mean AUC from time 0 to different cut points increased slightly more than dose proportionally .
-RESULTS	Although mean terminal t1/2 varied in the dose range tested , it did not show dose-dependence .
-RESULTS	The PK profiles of mipomersen in Japanese subjects are similar to those observed in Western subjects .
-RESULTS	A single SC dose of 50 mg , 100 mg and 200 mg mipomersen was well tolerated by male Japanese subjects .
-CONCLUSIONS	Single SC doses of 50 - 200 mg were safe and well tolerated when administered to Japanese subjects .
-CONCLUSIONS	Comparison of PK between Japanese and Western subjects does not support any need for dose adjustment in Japanese population in future clinical development .
-
-###25465680
-BACKGROUND	The granisetron transdermal system ( GTS ) showed non-inferior efficacy to oral granisetron to control chemotherapy-induced nausea and vomiting ( CINV ) during multiday chemotherapy .
-BACKGROUND	We compared the efficacy and safety of GTS with that of intravenous and oral granisetron in Korean patients receiving moderately emetogenic chemotherapy ( MEC ) .
-METHODS	A total of 276 patients were randomized into GTS ( n = 139 , one patch on days 1-4 ) or control group ( n = 137 , intravenous on day 1 and oral on days 2-4 ) .
-METHODS	The primary endpoint was the percentage of patients achieving complete response ( CR ) from chemotherapy initiation until 24 h after the final administration .
-RESULTS	Out of 234 patients ( 112 in GTS and 122 in control group ) included in the per protocol analysis , 97.9 % had gastrointestinal cancer and 76.9 % received 3-day chemotherapy .
-RESULTS	The GTS showed non-inferior efficacy achieving CR in 75.0 % of the patients ; 74.6 % of the patients in the control group achieved CR ( 95 % confidence interval -10.73 to 11.55 % ) .
-RESULTS	The CR rate did not change after subgroup analyses by sex , age , and chemotherapy naivety and analysis per day and overall days of treatment .
-RESULTS	The GTS group showed sustained CR from day 1 to day 4 .
-RESULTS	Patients ' satisfaction , assessed using Functional Living Index-Emesis ( FLI-E ) , showed no difference .
-RESULTS	Both treatments were well tolerated and safe .
-CONCLUSIONS	The GTS showed non-inferior efficacy to intravenous and oral granisetron .
-CONCLUSIONS	The safety , tolerability , and FLI-E scores of the GTS were comparable to those of control group .
-CONCLUSIONS	The GTS offers a convenient alternative option for relieving CINV in patients receiving MEC .
-
-###25225008
-BACKGROUND	The Creighton Model FertilityCare System ( CrMS ) teaches women to identify days when intercourse is likely to result in pregnancy .
-BACKGROUND	We sought to assess the impact of the CrMS on time to pregnancy ( TTP ) , via per-cycle pregnancy rates ( fecundability ) .
-METHODS	We conducted a parallel randomised trial at the University of Utah School of Medicine , 2003-06 .
-METHODS	Women ages 18-35 years , in a relationship of proven fertility , who desired to conceive , were block-randomised and stratified for age , with allocation concealment by opaque sequentially numbered sealed envelopes .
-METHODS	The control group received the advice to have intercourse 2-3 times per week , and the intervention group received CrMS instruction .
-METHODS	All women were asked to begin trying to conceive starting the second cycle in the study and were followed actively up to seven cycles , without blinding of research personnel .
-METHODS	We calculated descriptive statistics and fecundability , and estimated Cox models for TTP .
-METHODS	( Clinicaltrials.gov NCT00161395 ) .
-RESULTS	There were 143 women randomised : 71 to the control group ( all analysed ) and 72 to the CrMS group ( 69 analysed ) .
-RESULTS	The adjusted hazard ratio for the influence of CrMS on TTP was 0.86 [ 95 % confidence interval ( CI ) : 0.53 , 1.38 ] .
-RESULTS	Fecundability in cycles with intent to conceive was 31 % in controls and 36 % with CrMS ( P = 0.32 ) .
-RESULTS	By the first cycle , fecundability was 17 % in controls , and 4 % with CrMS ( P = 0.02 ) .
-RESULTS	No adverse events were reported .
-CONCLUSIONS	We found no significant impact of CrMS on TTP or fecundability , but fewer of the women receiving CrMS conceived by the first cycle .
-
-###25598270
-BACKGROUND	Migraine is a highly disabling disease affecting a significant proportion of the Australian population .
-BACKGROUND	The methylenetetrahydrofolate reductase ( MTHFR ) C677T variant has been associated with increased levels of homocysteine and risk of migraine with aura ( MA ) .
-BACKGROUND	Folic acid ( FA ) , vitamin B6 , and B12 supplementation has been previously shown to reduce increased levels of homocysteine and decrease migraine symptoms .
-BACKGROUND	However , the influence of dietary folate intake on migraine has been unclear .
-BACKGROUND	The aim of the current study was to analyze the association of dietary folate intake in the form of dietary folate equivalent , FA , and total food folate ( TFF ) on migraine frequency , severity , and disability .
-METHODS	A cohort of 141 adult females of Caucasian descent with MA was genotyped for the MTHFR C677T variant using restriction enzyme digestion .
-METHODS	Dietary folate information was collected from all participants and analyzed using the `` FoodWorks '' 2009 package .
-METHODS	Folate consumption was compared with migraine frequency , severity , and disability using linear regression .
-RESULTS	A significant inverse relation was observed between dietary folate equivalent ( R ( 2 ) = 0.201 , B = -0.002 , P = .045 , 95 % confidence interval [ CI ] [ -0.004 , -0.001 ] ) and FA ( R ( 2 ) = 0.255 , B = -0.005 , P = .036 , 95 % CI [ -0.009 , -0.002 ] ) consumption and migraine frequency .
-RESULTS	It was also observed that in individuals with the CC genotype for the MTHFR C677T variant , migraine frequency was significantly linked to FA consumption ( R ( 2 ) = 0.106 , B = -0.004 , P = .029 , 95 % CI [ -0.007 , -0.004 ] ) .
-CONCLUSIONS	The results from this study indicate that folate intake in the form of FA may influence migraine frequency in female MA sufferers .
-
-###24573909
-BACKGROUND	Electronic monitoring is recommended for accurate measurement of medication adherence but a possible limitation is that it may influence adherence .
-OBJECTIVE	To test the reactive effect of electronic monitoring in a randomized controlled trial .
-METHODS	A total of 226 adults with type 2 diabetes and HbA1c 58mmol/mol were randomized to receiving their main oral glucose lowering medication in electronic containers or standard packaging .
-METHODS	The primary outcomes were self-reported adherence measured with the MARS ( Medication Adherence Report Scale ; range 5-25 ) and HbA1c at 8weeks .
-RESULTS	Non-significantly higher adherence and lower HbA1c were observed in the electronic container group ( differences in means , adjusting for baseline value : MARS , 0.4 [ 95 % CI -0.1 to 0.8 , p = 0.11 ] ; HbA1c ( mmol/mol ) , -1.02 [ -2.73 to 0.71 , p = 0.25 ] ) .
-CONCLUSIONS	Electronic containers may lead to a small increase in adherence but this potential limitation is outweighed by their advantages .
-CONCLUSIONS	Our findings support electronic monitoring as the method of choice in research on medication adherence .
-CONCLUSIONS	( Trial registration Current Controlled Trials ISRCT N30522359 ) .
-
-###25343949
-OBJECTIVE	High levels of fibroblast growth factor 23 are associated with accelerated progression of CKD .
-OBJECTIVE	Whether high fibroblast growth factor 23 levels also predict incident CKD is uncertain .
-METHODS	A prospective case-cohort study was conducted within the Action to Control Cardiovascular Risk in Diabetes Trial .
-METHODS	The analytic sample consisted of a random subcohort of 590 patients with type 2 diabetes without prevalent CKD at baseline , 124 of whom developed incident CKD during follow-up , and 520 additional patients with incident CKD outside the random subcohort .
-METHODS	The association between serum intact fibroblast growth factor 23 and incident CKD , defined as the new onset of eGFR < 60 ml/min per 1.73 m ( 2 ) that represented a 25 % decrease from baseline in an individual with eGFR60 ml/min per 1.73 m ( 2 ) and no microalbuminuria ( < 30 mg/g creatinine ) at baseline , was tested .
-RESULTS	The mean baseline eGFR in the random subcohort was 90.922.7 ml/min per 1.73 m ( 2 ) .
-RESULTS	During a median follow-up of 4.7 years , there was a total of 644 patients with incident CKD .
-RESULTS	The median baseline fibroblast growth factor 23 level was modestly higher among patients with incident CKD versus controls ( 43.5 , interquartile range = 34.7-55 .1 versus 39.8 , interquartile range = 31.9-49 .5 pg/ml ; P < 0.001 ) .
-RESULTS	Higher baseline fibroblast growth factor 23 levels were associated with higher risk of incident CKD in unadjusted and demographics-adjusted models , but the effect was attenuated after additional adjustment for clinical risk factors and baseline eGFR ( hazard ratio per SD of natural log fibroblast growth factor 23 , 1.09 ; 95 % confidence interval , 0.94 to 1.27 ) , which was the strongest predictor of incident CKD .
-RESULTS	Consistent with the results of primary analyses , baseline fibroblast growth factor 23 was not associated with eGFR slope .
-CONCLUSIONS	Higher fibroblast growth factor 23 levels are not independently associated with higher risk of incident CKD in patients with type 2 diabetes .
-
-###24886098
-BACKGROUND	Many commencing junior doctors worldwide feel ill-prepared to deal with their new responsibilities , particularly prescribing .
-BACKGROUND	Simulation has been widely utilised in medical education , but the use of extended multi-method simulation to emulate the junior doctor experience has rarely been reported .
-METHODS	A randomised controlled trial compared students who underwent two , week-long , extended simulations , several months apart ( Intervention ) , with students who attended related workshops and seminars alone ( Control ) , for a range of outcome measures .
-RESULTS	Eighty-four third year students in a graduate-entry medical program were randomised , and 82 completed the study .
-RESULTS	At the end of the first week , Intervention students scored a mean of 75 % on a prescribing test , compared with 70 % for Control students ( P = 0.02 ) and Intervention teams initiated cardiac compressions a mean of 29.1 seconds into a resuscitation test scenario , compared with 70.1 seconds for Control teams ( P < 0.01 ) .
-RESULTS	At the beginning of the second week , an average of nine months later , a significant difference was maintained in relation to the prescribing test only ( 78 % vs 70 % , P < 0.01 ) .
-RESULTS	At the end of the second week , significant Intervention vs Control differences were seen on knowledge and reasoning tests , a further prescribing test ( 71 % vs 63 % [ P < 0.01 ] ) and a paediatric resuscitation scenario test ( 252 seconds to initiation of fluid resuscitation vs 339 seconds [ P = 0.05 ] ) .
-CONCLUSIONS	The study demonstrated long-term retention of improved prescribing skills , and an immediate effect on knowledge acquisition , reasoning and resuscitation skills , from contextualising learning activities through extended multi-method simulation .
-
-###25038532
-OBJECTIVE	Identify predictors of non-compliance with first round screening exams in the Prostate , Lung , Colorectal and Ovarian ( PLCO ) Cancer Screening Trial .
-METHODS	The PLCO was conducted from 1993 to 2011 at 10 US institutions .
-METHODS	A total of 154,897 healthy men and women ages 55-74 years were randomized .
-METHODS	Intervention arm participants were invited to receive gender-appropriate screening exams for prostate , lung , colorectal and ovarian cancer .
-METHODS	Using intervention-arm data ( 73,036 participants ) , non-compliance percentages for 13 covariates were calculated , as were unadjusted and adjusted odds ratios ( ORs ) , and 95 % confidence intervals .
-METHODS	Covariates included demographic factors as well as factors specific to PLCO ( e.g. , method of consent , distance from screening center ) .
-RESULTS	The rate of non-compliance was 11 % overall but varied by screening center .
-RESULTS	Significant associations were observed for most covariates but indicated modest increases or decreases in odds .
-RESULTS	An exception was the use of a two-step consent process ( consented intervention arm participants for exams after randomization ) relative to a one-step process ( consented all participants prior to randomization ) ( OR : 2.2 , 95 % CI : 2.0-2 .5 ) .
-RESULTS	Non-compliance percentages increased with further distance from screening centers , but ORs were not significantly different from 1 .
-CONCLUSIONS	Many factors modestly influenced compliance .
-CONCLUSIONS	Consent process was the strongest predictor of compliance .
-
-###24491874
-BACKGROUND	Regular exercise is an effective intervention to decrease blood pressure ( BP ) in hypertension , but no data are available concerning the effects of heated water-based exercise ( HEx ) .
-BACKGROUND	This study examines the effects of HEx on BP in resistant hypertensive patients .
-METHODS	This is a parallel , randomized controlled trial .
-METHODS	125 nonconsecutive sedentary patients with resistant hypertension from a hypertension outpatient clinic in a university hospital were screened ; 32 patients fulfilled the study requirements .
-METHODS	The training was performed for 60-minute sessions in a heated pool ( 32C ) , three times a week for 12 weeks .
-METHODS	The HEx protocol consisted of callisthenic exercises and walking inside the pool .
-METHODS	The control group was asked to maintain habitual activities .
-METHODS	The main outcome measure was change in mean 24-hour ambulatory BP ( ABPM ) .
-RESULTS	32 patients ( HEx n = 16 ; control n = 16 ) were randomized ; none were lost to follow-up .
-RESULTS	Office BPs decreased significantly after heated water exercise ( 36/12 mmHg ) .
-RESULTS	HEx decreased 24-hour systolic ( from 13723 to 12012 mmHg , p = 0.001 ) and diastolic BPs ( from 8113 to 7210 mmHg , p = 0.009 ) ; daytime systolic ( from 14124 to 12013 mmHg , p < 0.0001 ) and diastolic BPs ( from 8414 to 7311 mmHg , p = 0.003 ) ; and nighttime systolic ( from 12922 to 11412 mmHg , p = 0.006 ) and diastolic BPs ( from 7411 to 6610 mmHg , p < 0.0001 ) .
-RESULTS	The control group after 12 weeks significantly increased in 24-hour systolic and diastolic BPs , and daytime and nighttime diastolic BPs .
-CONCLUSIONS	HEx reduced office BPs and 24-hour ABPM levels in resistant hypertensive patients .
-CONCLUSIONS	These effects suggest that HEx may be a potential new therapeutic approach in these patients .
-
-###25111351
-BACKGROUND	Botulinum neurotoxin type A trials in aesthetic indications have used differing efficacy parameters and responder definitions .
-OBJECTIVE	To analyze the treatment efficacy and duration of incobotulinumtoxinA for glabellar frown lines using pooled data from 2 large , Phase 3 , placebo-controlled trials , and end points similar to those used in previous botulinum neurotoxin type A studies .
-METHODS	IncobotulinumtoxinA and placebo groups comprised 366 and 181 subjects , respectively .
-METHODS	The efficacy of a single 20-U treatment of incobotulinumtoxinA or placebo was evaluated by investigator-assessed and subject-assessed responder rates ( 1-point improvement from baseline ) , mean score , and mean change from the baseline glabellar frown line severity score .
-RESULTS	At all follow-up visits , responder rates and mean change from the baseline score ( investigator-assessed and subject-assessed ) were significantly greater for incobotulinumtoxinA versus placebo ( p < .0001 ) .
-RESULTS	The maximum investigator-assessed responder rate ( 93.1 % ) was achieved at Day 30 after treatment , when the mean improvement on the 4-point facial wrinkle scale peaked at 1.88 .
-RESULTS	Treatment effect declined over time but the investigator-assessed responder rate was 45.7 % at the end of the study .
-CONCLUSIONS	Superiority of incobotulinumtoxinA over placebo for treating glabellar frown lines was confirmed .
-CONCLUSIONS	IncobotulinumtoxinA achieved a maximum responder rate of 93.1 % and a long duration of treatment effect : 45.7 % of subjects showed efficacy at 120 days .
-
-###25542740
-OBJECTIVE	To investigate whether standardised cigarette packaging increases the time spent looking at health warnings , regardless of the format of those warnings .
-METHODS	A factorial ( two pack styles x three warning types ) within-subject experiment , with participants randomised to different orders of conditions , completed at a university in London , UK .
-METHODS	Mock-ups of cigarette packets were presented to participants with their branded portion in either standardised ( plain ) or manufacturer-designed ( branded ) format .
-METHODS	Health warnings were present on all packets , representing all three types currently in use in the UK : black & white text , colour text , or colour images with accompanying text .
-METHODS	Gaze position was recorded using a specialised eye tracker , providing the main outcome measure , which was the mean proportion of a five-second viewing period spent gazing at the warning-label region of the packet .
-RESULTS	An opportunity sample of 30 ( six male , mean age = 23 ) young adults met the following inclusion criteria : 1 ) not currently a smoker ; 2 ) < 100 lifetime cigarettes smoked ; 3 ) gaze position successfully tracked for > 50 % viewing time .
-RESULTS	These participants spent a greater proportion of the available time gazing at the warning-label region when the branded section of the pack was standardised ( following current Australian guidelines ) rather than containing the manufacturer 's preferred design ( mean difference in proportions = 0.078 , 95 % confidence interval 0.049 to 0.106 , p < 0.001 ) .
-RESULTS	There was no evidence that this effect varied based on the type of warning label ( black & white text vs. colour text vs. colour image & text ; interaction p = 0.295 ) .
-CONCLUSIONS	During incidental viewing of cigarette packets , young adult never-smokers are likely to spend more time looking at health warnings if manufacturers are compelled to use standardised packaging , regardless of the warning design .
-
-###25287821
-OBJECTIVE	To provide the 4-week prevalence estimates of mental disorders in cancer populations .
-METHODS	We enrolled adult patients with cancer from in - and outpatient care facilities , using a proportional stratified random sample based on the nationwide cancer incidence in Germany .
-METHODS	Patients who scored 9 or above on the Patient Health Questionnaire ( PHQ-9 ) were administered to the standardized computer-assisted Composite International Diagnostic Interview for mental disorders adapted for cancer patients ( CIDI-O ) .
-METHODS	A random sample of those with a PHQ-9 score that was less than 9 were selected for a CIDI-O .
-RESULTS	A total of 5,889 patients were identified , which led to 4,020 participants ( a 68.3 % response rate ) ; of those , 2,141 patients were interviewed .
-RESULTS	The 4-week total prevalence for any mental disorder was 31.8 % ( 95 % CI , 29.8 % to 33.8 % ) ; this included any anxiety disorder ( 11.5 % ; 95 % CI , 10.2 % to 12.9 % ) , any adjustment disorder ( 11.1 % ; 95 % CI , 9.7 % to 12.4 % ) , any mood disorder ( 6.5 % ; 95 % CI , 5.5 % to 7.5 % ) , any somatoform/conversion disorder ( 5.3 % ; 95 % CI , 4.3 % to 6.2 % ) , nicotine dependence ( 4.5 % ; 95 % CI , 3.6 % to 5.4 % ) , alcohol abuse/dependence ( 0.3 % ; 95 % CI , 0.1 % to 0.6 % ) , any mental disorder resulting from general medical condition ( 2.3 % ; 95 % CI , 1.7 % to 2.9 % ) , and any eating disorder ( 0 % ) .
-RESULTS	The highest prevalence for any mental disorder was found in patients with breast cancer ( 41.6 % ; 95 % CI , 36.8 % to 46.4 % ) , followed by patients with head and neck cancer ( 40.8 % ; 95 % CI , 28.5 % to 53.0 % ) .
-RESULTS	The lowest prevalence was found in patients with pancreatic cancer ( 20.3 % ; 95 % CI , 8.9 % to 31.6 % ) and stomach/esophagus cancers ( 21.2 % ; 95 % CI , 12.8 % to 29.6 % ) .
-CONCLUSIONS	Our findings provide evidence for the strong need for psycho-oncological interventions .
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-###24910976
-BACKGROUND	Birt-Hogg-Dub syndrome ( BHD ) is a rare autosomal dominant disorder characterised by the occurrence of benign , mostly facial , skin tumours called fibrofolliculomas , multiple lung cysts , spontaneous pneumothorax and an increased renal cancer risk .
-BACKGROUND	Current treatments for fibrofolliculomas have high rates of recurrence and carry a risk of complications .
-BACKGROUND	It would be desirable to have a treatment that could prevent fibrofolliculomas from growing .
-BACKGROUND	Animal models of BHD have previously shown deregulation of mammalian target of rapamycin ( mTOR ) .
-BACKGROUND	Topical use of the mTOR inhibitor rapamycin is an effective treatment for the skin tumours ( angiofibromas ) in tuberous sclerosis complex , which is also characterised by mTOR deregulation .
-BACKGROUND	In this study we aimed to determine if topical rapamycin is also an effective treatment for fibrofolliculomas in BHD. .
-METHODS	We performed a double blinded , randomised , facial left-right controlled trial of topical rapamycin 0.1 % versus placebo in 19 BHD patients .
-METHODS	Trial duration was 6 months .
-METHODS	The primary outcome was cosmetic improvement as measured by doctors and patients .
-METHODS	Changes in fibrofolliculoma number and size were also measured , as was occurrence of side effects .
-RESULTS	No change in cosmetic status of fibrofolliculomas was reported in the majority of cases for the rapamycin treated ( 79 % by doctors , 53 % by patients ) as well as the placebo treated facial sides ( both 74 % ) .
-RESULTS	No significant differences between rapamycin and placebo treated facial halves were observed ( p = 1.000 for doctors opinion , p = 0.344 for patients opinion ) .
-RESULTS	No significant difference in fibrofolliculoma number or change in size of the fibrofolliculomas was seen after 6 months .
-RESULTS	Side effects occurred more often after rapamycin treatment ( 68 % of patients ) than after placebo ( 58 % of patients ; p = 0.625 ) .
-RESULTS	A burning sensation , erythema , itching and dryness were most frequently reported .
-CONCLUSIONS	This study provides no evidence that treatment of fibrofolliculomas with topical rapamycin in BHD results in cosmetic improvement .
-BACKGROUND	ClinicalTrials.gov NCT00928798 .
-
-###24263289
-BACKGROUND	Accurately estimating the period of time that individuals are exposed to online intervention content is important for understanding program engagement .
-BACKGROUND	This can be calculated from time-stamped data reflecting navigation to and from individual webpages .
-BACKGROUND	Prolonged periods of inactivity are commonly handled with a time-out feature and assigned a prespecified exposure duration .
-BACKGROUND	Unfortunately , this practice can lead to biased results describing program exposure .
-OBJECTIVE	The aim of the study was to describe how multiple imputations can be used to better account for the time spent viewing webpages that result in a prolonged period of inactivity or a time-out .
-METHODS	To illustrate this method , we present data on time-outs collected from the Q ( 2 ) randomized smoking cessation trial .
-METHODS	For this analysis , we evaluate the effects on intervention exposure of receiving content written in a prescriptive versus motivational tone .
-METHODS	Using multiple imputations , we created five complete datasets in which the time spent viewing webpages that resulted in a time-out were replaced with values estimated with imputation models .
-METHODS	We calculated standard errors using Rubin 's formulas to account for the variability due to the imputations .
-METHODS	We also illustrate how current methods of accounting for time-outs ( excluding timed-out page views or assigning an arbitrary viewing time ) can influence conclusions about participant engagement .
-RESULTS	A total of 63.00 % ( 1175/1865 ) of participants accessed the online intervention in the Q ( 2 ) trial .
-RESULTS	Of the 6592 unique page views , 683 ( 10.36 % , 683/6592 ) resulted in a time-out .
-RESULTS	The median time spent viewing webpages that did not result in a time-out was 1.07 minutes .
-RESULTS	Assuming participants did not spend any time viewing a webpage that resulted in a time-out , no difference between the two message tones was observed ( ratio of mean time online : 0.87 , 95 % CI 0.75-1 .02 ) .
-RESULTS	Assigning 30 minutes of viewing time to all page views that resulted in a time-out concludes that participants who received content in a motivational tone spent less time viewing content ( ratio of mean time online : 0.86 , 95 % CI 0.77-0 .98 ) than those participants who received content in a prescriptive tone .
-RESULTS	Using multiple imputations to account for time-outs concludes that there is no difference in participant engagement between the two message tones ( ratio of mean time online : 0.87 ; 95 % CI 0.75-1 .01 ) .
-CONCLUSIONS	The analytic technique chosen can significantly affect conclusions about online intervention engagement .
-CONCLUSIONS	We propose a standardized methodology in which time spent viewing webpages that result in a time-out is treated as missing information and corrected with multiple imputations .
-BACKGROUND	Clinicaltrials.gov NCT00992264 ; http://clinicaltrials.gov/ct2/show/NCT00992264 ( Archived by WebCite at http://www.webcitation.org/6Kw5m8EkP ) .
-
-###25714214
-OBJECTIVE	To evaluate the lung function and clinical outcome in severe chronic obstructive pulmonary disease in patients undergoing off-pump coronary artery bypass grafting with left internal thoracic artery graft , comparing the pleural drain insertion in the intercostal versus subxyphoid region .
-METHODS	A randomized controlled trial .
-METHODS	Chronic obstructive pulmonary disease patients were randomized into two groups according pleural drain site : II group ( n = 27 ) - pleural drain in intercostal space ; SI group ( n = 29 ) - pleural drain in the subxyphoid region .
-METHODS	Spirometry values ( Forced Vital Capacity - and Forced expiratory volume in 1 second ) were obtained on preoperative and 1 , 3 and 5 postoperative days .
-METHODS	Chest x-ray from preoperative until postoperative day 5 ( POD5 ) was performed for monitoring respiratory events , such as atelectasis and pleural effusion .
-METHODS	Pulmonary shunt fraction and pain score was evaluate preoperatively and on postoperative day 1 .
-RESULTS	In both groups there was a significant decrease of the spirometry values ( Forced Vital Capacity and Forced expiratory volume in 1 second ) until POD5 ( P < 0.05 ) .
-RESULTS	However , when compared , SI group presented less decrease in these parameters ( P < 0.05 ) .
-RESULTS	Pulmonary shunt fraction was significantly lower in SI group ( P < 0.05 ) .
-RESULTS	Respiratory events , pain score , orotracheal intubation time and postoperative length of hospital stay were lower in the SI group ( P < 0.05 ) .
-CONCLUSIONS	Subxyphoid pleural drainage in severe Chronic obstructive pulmonary disease patients determined better preservation and recovery of pulmonary capacity and volumes with lower pulmonary shunt fraction and better clinical outcomes on early postoperative off-pump coronary artery bypass grafting .
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-###24342746
-OBJECTIVE	Little is known about the effects of natural mineral water on constipation in adults .
-OBJECTIVE	We assessed the effect of a magnesium sulfate-rich natural mineral water ( Hpar ; Nestl Waters , Issy-les-Moulineaux , France ) on gastrointestinal transit in constipated women .
-METHODS	We performed a randomized , double-blind , placebo-controlled trial to evaluate the efficacy and safety of Hpar in outpatients with functional constipation ( based on the Rome III criteria ) .
-METHODS	The study included 244 female patients , age 18 to 60 years , identified by 62 general practitioners throughout France .
-METHODS	After a washout period , subjects drank 1.5 L natural low-mineral water daily ( control , n = 77 ) , 0.5 L Hpar and 1 L natural low-mineral water daily ( Hpar 0.5 group , n = 85 ) , or 1 L Hpar and 0.5 L natural low-mineral water daily ( Hpar 1 group , n = 82 ) for 4 weeks .
-METHODS	We collected information on the number and types of stools , abdominal pain , rescue medications , adverse events , and volume of water consumed .
-RESULTS	We observed no significant effect at week 1 .
-RESULTS	At week 2 , constipation was reduced in 21.1 % of patients in the control group , in 30.9 % in the Hpar 0.5 group ( P = .099 vs controls ) , and in 37.5 % in the Hpar 1 group ( P = .013 vs controls ) .
-RESULTS	The Hpar 1 group also had a decreased number of hard or lumpy stools ( Bristol scale , P = .030 vs baseline ) and a substantial decrease in the use of rescue medication ( P = .034 vs controls ) .
-RESULTS	Patient responses correlated with magnesium sulfate concentrations .
-RESULTS	Safety was very good ; there were no serious adverse events among patients who drank Hpar .
-CONCLUSIONS	In a controlled trial , daily consumption of 1 L Hpar reduced constipation and hard or lumpy stools in a greater percentage of women with functional constipation than natural low-mineral water , as early as the second week of treatment .
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-###25135542
-OBJECTIVE	To evaluate the efficacy of adding nepafenac 0.1 % ophthalmic suspension to dexamethasone 0.1 % eyedrops in controlling macular swelling and other manifestations of inflammation after uneventful cataract surgery .
-METHODS	Ophthalmology Department , Mlndal Hospital , Gothenburg , and St. Erik Eye Hospital , Stockholm , Sweden .
-METHODS	Randomized double-masked clinical trial .
-METHODS	Patients at low risk for postoperative inflammation were recruited and randomized to the nepafenac group or to the control group .
-METHODS	Postoperative swelling of the macula was assessed with ocular coherence tomography .
-METHODS	Laser flare intensity , corrected distance visual acuity , ocular discomfort , and visual complaints were also recorded .
-RESULTS	The analysis of intent-to-treat population comprised 75 patients in the nepafenac group and 77 patients in the control group .
-RESULTS	Compared with the control regimen , add-on nepafenac resulted in statistically significant reductions in the following parameters : change in macular volume at 3 weeks and 6 weeks ( P < .001 ) , proportion of patients with more than 10 m of swelling in the central macula at 3 weeks ( P < .0001 ) and 6 weeks ( P = .02 ) , mean laser flare intensity at 1 day ( P = .029 ) , pain during the first 24 hours postoperatively ( P < .0001 ) , and ocular discomfort and photophobia during the first 3 postoperative weeks ( P = .0058 and P = .0052 , respectively ) .
-CONCLUSIONS	The combination of topical nepafenac and steroid treatment reduced subclinical macular swelling and inflammation as well as subjective complaints , indicating it is an efficient antiinflammatory regimen after cataract surgery .
-BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .
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-###24625502
-OBJECTIVE	Cutaneous telangiectases are a characteristic and psychologically distressing feature of SSc .
-OBJECTIVE	Our aim was to assess the efficacy of two light-based treatments : pulsed dye laser ( PDL ) and intense pulsed light ( IPL ) .
-METHODS	Nineteen patients with facial or upper limb telangiectases underwent three treatments with PDL and IPL ( randomly assigned to left - and right-sided lesions ) .
-METHODS	Outcome measures were clinical photography ( assessed by two clinicians ) , dermoscopy ( assessed by two observers ) , laser Doppler imaging ( LDI ) and observer and patient opinion , including patient self-assessment psychological questionnaires [ Hospital Anxiety and Depression Scale ( HADS ) , Adapted Satisfaction with Appearance Scale ( ASWAP ) ] .
-RESULTS	Comparison between 16-week follow-up and baseline photography scores ( from -2 to +2 on a Likert scale , with > 0 being improvement ) were a mean score for PDL of 1.7 ( 95 % CI 1.4 , 2.0 ) and for IPL 1.4 ( 0.9 , 1.8 ) , with a mean difference between PDL and IPL of -0.3 ( -0.5 , -0.1 ) ( P = 0.01 ) .
-RESULTS	Dermoscopy scores also improved with both therapies : PDL 1.3 ( 1.1 , 1.5 ) and IPL 0.8 ( 0.5 , 1.1 ) , again greater with PDL ( P = 0.01 ) .
-RESULTS	LDI showed decreases in blood flow at 16 weeks , indicating a response to both therapies .
-RESULTS	All patients reported benefit from treatment ( more preferred PDL at 16 weeks ) .
-RESULTS	Psychological questionnaires also indicated improvement after therapy with mean change in ASWAP of -13.9 ( 95 % CI -20.5 , -7.4 ) .
-RESULTS	No side effects were reported for IPL ; PDL caused transient bruising in most cases .
-CONCLUSIONS	Both PDL and IPL are effective treatments for SSc-related telangiectases .
-CONCLUSIONS	Outcome measures indicate that PDL has better outcomes in terms of appearance , although IPL had fewer side effects .
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-###25146745
-OBJECTIVE	To explore the roles of ribavirin aerosol in the prevention and treatment of hand-foot-mouth disease ( HFMD ) .
-METHODS	For this prospective , multicenter , randomized , double-blind and placebo-controlled trial , a total of 300 HFMD outpatients from 3 class 3A hospitals from July 2011 to June 2013 were divided into treatment ( ribavirin aerosol ) and control ( placebo ) groups ( n = 150 each ) .
-METHODS	The age range was 6 months to 6 years .
-METHODS	The proportion of male and female was 1.5 : 1 .
-METHODS	Temperature , herpes of mouth and skin rash were observed before and after treatments .
-METHODS	Before treatment and 6-7 days after , their specimens of throat swab were collected and the levels of EV71 and CA16 detected with reverse transcription ( RT ) - PCR .
-METHODS	The software SAS 9.2 was used for statistic data analyses .
-RESULTS	Before treatment , no significant statistical difference existed in parameters between treatment and control groups ( all P > 0.05 ) .
-RESULTS	After treatment , the degree of herpes of mouth and papulovesicle of skin in treatment group was better than that in control group ( 100.0 % ( 147/147 ) vs 83.9 % ( 120/143 ) , ( 2 ) = 109.21 , P < 0.01 ) ; ( 100.0 % ( 147/147 ) vs 95.9 % ( 139/145 ) , ( 2 ) = 6.38 , P < 0.05 ) .
-RESULTS	The virus negative conversion rates had significant inter-group difference ( 80.0 % ( 102/110 ) vs 41.8 % ( 41/98 ) , ( 2 ) = 37.06 , P < 0.01 ) .
-RESULTS	The temperature , compliance and differences were not significant ( all P > 0.05 ) .
-RESULTS	The effective rate of comprehensive efficacy in treatment group was higher than that in control group ( 93.9 % ( 122/130 ) vs 52.0 % ( 64/123 ) , ( 2 ) = 111.08 , P < 0.01 ) .
-RESULTS	No obvious adverse drug reaction was observed .
-CONCLUSIONS	Ribavirin aerosol has multiple advantages of lower dose , quicker onset , higher local concentration , better clinical efficacy and fewer side-effects .
-CONCLUSIONS	Its therapeutic effect for local lesion is better than that for systemic lesion .
-CONCLUSIONS	Thus it may shorten the duration of oropharyngeal and skin lesions and lower the number and time of viral release .
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-###25701561
-BACKGROUND	Early combination antiretroviral therapy ( cART ) initiation at the time of primary HIV-1 infection could restrict the establishment of HIV reservoirs .
-BACKGROUND	We aimed to assess the effect of a cART regimen intensified with raltegravir and maraviroc , compared with standard triple-drug cART , on HIV-DNA load .
-METHODS	In this randomised , open-label , phase 3 trial , we recruited patients from hospitals across France .
-METHODS	Inclusion criteria were primary HIV-1 infection ( an incomplete HIV-1 western blot and detectable plasma HIV-RNA ) , with either symptoms or a CD4 + cell count below 500 cells per L. Patients were randomly assigned ( 1:1 ) to an intensive , five-drug cART regimen ( raltegravir 400 mg and maraviroc 150 mg twice daily , and a fixed-dose combination of tenofovir disoproxil fumarate 300 g plus emtricitabine 200 g , darunavir 800 g , and ritonavir 100 g once daily ) or a standard triple-drug cART regimen ( tenofovir disoproxil fumarate 300 g plus emtricitabine 200 g , darunavir 800 g , and ritonavir 100 g once daily ) using a predefined randomised list generated by randomly selected variable block sizes .
-METHODS	The primary endpoint was the median number of HIV-DNA copies per 10 ( 6 ) peripheral blood mononuclear cells ( PBMC ) at month 24 , analysed in the modified intention-to-treat population , defined as all patients who started their assigned treatment .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT01033760 .
-RESULTS	Between April 26 , 2010 , and July 13 , 2011 , 110 patients were enrolled , of whom 92 were randomly assigned and 90 started treatment ( 45 in each treatment group ) .
-RESULTS	Six ( 13 % ) patients in the intensive cART group and two ( 4 % ) in the standard cART group discontinued before month 24 .
-RESULTS	At month 24 , HIV-DNA loads were similar between groups ( 235 [ IQR 205-250 ] log per 10 ( 6 ) PBMC in the intensive cART group vs 225 [ 171-255 ] in the standard cART group ; p = 021 ) .
-RESULTS	Eight grade 3-4 clinical adverse events were reported in seven patients in the intensive cART group and seven grade 3-4 clinical adverse events were reported in seven patients in the standard cART group .
-RESULTS	Three serious clinical adverse events occurred : two ( pancreatitis and lipodystrophy ) in the standard cART group , which were regarded as treatment related , and one event ( suicide attempt ) in the intensive cART group that was unrelated to treatment .
-CONCLUSIONS	After 24 months , cART intensified with raltegravir and maraviroc did not have a greater effect on HIV blood reservoirs than did standard cART .
-CONCLUSIONS	These results should help to design future trials of treatments aiming to decrease the HIV reservoir in patients with primary HIV-1 infection .
-BACKGROUND	Inserm-ANRS , Gilead Sciences , Janssen Pharmaceuticals , Merck , and ViiV Laboratories .
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-###25503625
-OBJECTIVE	To test the effects of pregabalin on the induction of neurogenic claudication .
-METHODS	This study was a randomized , double-blind , active placebo-controlled , 2-period , crossover trial .
-METHODS	Twenty-nine subjects were randomized to receive pregabalin followed by active placebo ( i.e. , diphenhydramine ) or active placebo followed by pregabalin .
-METHODS	Each treatment period lasted 10 days , including a 2-step titration .
-METHODS	Periods were separated by a 10-day washout period , including a 3-day taper phase after the first period .
-METHODS	The primary outcome variable was the time to first moderate pain symptom ( Numeric Rating Scale score 4 ) during a 15-minute treadmill test ( Tfirst ) .
-METHODS	Secondary outcome measures included pain intensity at rest , pain intensity at the end of the treadmill test , distance walked , and validated self-report measures of pain and functional limitation including the Roland-Morris Disability Questionnaire , modified Brief Pain Inventory-Short Form , Oswestry Disability Index , and Swiss Spinal Stenosis Questionnaire .
-RESULTS	No significant difference was found between pregabalin and active placebo for the time to first moderate pain symptom ( difference in median Tfirst = -1.08 [ 95 % confidence interval -2.25 to 0.08 ] , p = 0.61 ) .
-RESULTS	In addition , none of the secondary outcome measures of pain or functional limitation were significantly improved by pregabalin compared with active placebo .
-CONCLUSIONS	Pregabalin was not more effective than active placebo in reducing painful symptoms or functional limitations in patients with neurogenic claudication associated with lumbar spinal stenosis .
-METHODS	This study provides Class I evidence that for patients with neurogenic claudication , compared with diphenhydramine , pregabalin does not increase the time to moderate pain during a treadmill test .
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-###25053388
-OBJECTIVE	A phase 1 study was conducted to evaluate the bioavailability and food effect of a new veliparib formulation in subjects with solid tumors .
-METHODS	Subjects ( planned : Stage I , N = 20 ; Stage II , N = 16 ) received four regimens of a single oral dose of veliparib utilizing a group-sequential design .
-METHODS	Subjects were administered single doses of 40 mg veliparib supplied as four 10 mg current formulation , four 10 mg new formulation and one 40 mg new formulation under fasting conditions and under non-fasting conditions .
-METHODS	Serial blood samples were collected for the determination of veliparib pharmacokinetics .
-METHODS	At the end of Stage I , the relative bioavailability between each pair of regimens was assessed by a two one-sided tests procedure from the analyses of the natural logarithms of C ( max ) and AUC .
-METHODS	A 92.7 % confidence interval within the 0.80-1 .25 range between each regimen pair determined bioequivalence .
-RESULTS	Four 10 mg current formulation capsules , four 10 mg new formulation and one 40 mg new formulation were bioequivalent with respect to C ( max ) and AUC under fasting conditions .
-RESULTS	The administration of a high-fat meal did not have a significant effect on AUC and only caused a slight decrease in veliparib C ( max ) ( 17 % ) and a delay of approximately 1 h in T ( max ) .
-CONCLUSIONS	The 40 mg new capsule was bioequivalent to currently used formulation .
-CONCLUSIONS	Food had no effect on the extent of veliparib absorption and only a small ( 17 % ) decrease in peak exposure of veliparib .
-
-###25012498
-BACKGROUND	Renin-angiotensin system inhibition ( RASI ) is frequently avoided in aortic stenosis ( AS ) patients because of fear of hypotension .
-BACKGROUND	We evaluated if RASI with angiotensin-converting enzyme inhibitor ( ACEI ) or angiotensin receptor blocker ( ARB ) increased mortality in patients with mild to moderate AS .
-METHODS	All patients ( n = 1873 ) from the Simvastatin and Ezetimibe in Aortic Stenosis study : asymptomatic patients with AS and preserved left ventricular ( LV ) ejection fraction were included .
-METHODS	Risks of sudden cardiac death ( SCD ) , cardiovascular death and all-cause mortality according to RASI treatment were analyzed by multivariable time-varying Cox models and propensity score matched analyses .
-RESULTS	769 ( 41 % ) patients received RASI .
-RESULTS	During a median follow-up of 4.3 0.9 years , 678 patients were categorized as having severe AS , 545 underwent aortic valve replacement , 40 SCDs , 103 cardiovascular and 205 all-cause deaths occurred .
-RESULTS	RASI was not associated with SCD ( HR : 1.19 [ 95 % CI : 0.50-2 .83 ] , p = 0.694 ) , cardiovascular ( HR : 1.05 [ 95 % CI : 0.62-1 .77 ] , p = 0.854 ) or all-cause mortality ( HR : 0.81 [ 95 % CI : 0.55-1 .20 ] , p = 0.281 ) .
-RESULTS	This was confirmed in propensity matched analysis ( all p > 0.05 ) .
-RESULTS	In separate analyses , RASI was associated with larger reduction in systolic blood pressure ( p = 0.001 ) and less progression of LV mass ( p = 0.040 ) .
-CONCLUSIONS	RASI was not associated with SCD , cardiovascular or all-cause mortality in asymptomatic AS patients .
-CONCLUSIONS	However , RASI was associated with a potentially beneficial decrease in blood pressure and reduced LV mass progression .
-
-###25247991
-BACKGROUND	Exercise capacity is a strong predictor of survival in patients with coronary artery disease ( CAD ) .
-BACKGROUND	Exercise capacity improves after cardiac rehabilitation exercise training , but previous studies have demonstrated a decline in peak oxygen uptake after ending a formal rehabilitation program .
-BACKGROUND	There is a lack of knowledge on how long-term exercise adherence can be achieved in CAD patients .
-BACKGROUND	We therefore assessed if a 12-month maintenance program following cardiac rehabilitation would lead to increased adherence to exercise and increased exercise capacity compared to usual care .
-METHODS	Two-centre , open , parallel randomized controlled trial with 12 months follow-up comparing usual care to a maintenance program .
-METHODS	The maintenance program consisted of one monthly supervised high intensity interval training session , a written exercise program and exercise diary , and a maximum exercise test every third month during follow-up .
-METHODS	Forty-nine patients ( 15 women ) on optimal medical treatment were included following discharge from cardiac rehabilitation .
-METHODS	The primary endpoint was change in peak oxygen uptake at follow-up ; secondary endpoints were physical activity level , quality of life and blood markers of cardiovascular risk .
-RESULTS	There was no change in peak oxygen uptake from baseline to follow-up in either group ( intervention group 27.9 ( 4.7 ) to 28.8 ( 5.6 ) mLkg ( -1 ) min ( -1 ) , control group 32.0 ( 6.2 ) to 32.8 ( 5.8 ) mLkg ( -1 ) min ( -1 ) , with no between-group difference , p = 0.22 ) .
-RESULTS	Quality of life and blood biomarkers remained essentially unchanged , and both self-reported and measured physical activity levels were similar between groups after 12 months .
-CONCLUSIONS	A maintenance exercise program for 12 months did not improve adherence to exercise or peak oxygen uptake in CAD patients after discharge from cardiac rehabilitation compared to usual care .
-CONCLUSIONS	This suggests that infrequent supervised high intensity interval training sessions are inadequate to improve peak oxygen uptake in this patient group .
-BACKGROUND	ClinicalTrials.gov NCT01246570 .
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-###25776532
-BACKGROUND	Early , goal-directed therapy ( EGDT ) is recommended in international guidelines for the resuscitation of patients presenting with early septic shock .
-BACKGROUND	However , adoption has been limited , and uncertainty about its effectiveness remains .
-METHODS	We conducted a pragmatic randomized trial with an integrated cost-effectiveness analysis in 56 hospitals in England .
-METHODS	Patients were randomly assigned to receive either EGDT ( a 6-hour resuscitation protocol ) or usual care .
-METHODS	The primary clinical outcome was all-cause mortality at 90 days .
-RESULTS	We enrolled 1260 patients , with 630 assigned to EGDT and 630 to usual care .
-RESULTS	By 90 days , 184 of 623 patients ( 29.5 % ) in the EGDT group and 181 of 620 patients ( 29.2 % ) in the usual-care group had died ( relative risk in the EGDT group , 1.01 ; 95 % confidence interval [ CI ] , 0.85 to 1.20 ; P = 0.90 ) , for an absolute risk reduction in the EGDT group of -0.3 percentage points ( 95 % CI , -5.4 to 4.7 ) .
-RESULTS	Increased treatment intensity in the EGDT group was indicated by increased use of intravenous fluids , vasoactive drugs , and red-cell transfusions and reflected by significantly worse organ-failure scores , more days receiving advanced cardiovascular support , and longer stays in the intensive care unit .
-RESULTS	There were no significant differences in any other secondary outcomes , including health-related quality of life , or in rates of serious adverse events .
-RESULTS	On average , EGDT increased costs , and the probability that it was cost-effective was below 20 % .
-CONCLUSIONS	In patients with septic shock who were identified early and received intravenous antibiotics and adequate fluid resuscitation , hemodynamic management according to a strict EGDT protocol did not lead to an improvement in outcome .
-CONCLUSIONS	( Funded by the United Kingdom National Institute for Health Research Health Technology Assessment Programme ; ProMISe Current Controlled Trials number , ISRCTN36307479 . )
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-###24462498
-OBJECTIVE	To identify characteristics of hemodialysis patients most likely to experience difficulty adhering to sodium restrictions associated with their dietary regimen .
-METHODS	Secondary analysis using baseline data from an ongoing randomized clinical trial examining the effects of a technology-supported behavioral intervention on dietary sodium intake in hemodialysis patients .
-METHODS	Thirteen dialysis centers in southwestern Pennsylvania .
-METHODS	We included 122 participants ( 61 % women ; 48 % African American ) aged 61 14 years undergoing maintenance , intermittent hemodialysis for end-stage renal disease .
-METHODS	Normalized dietary sodium intake , adjusted interdialytic weight gain , perceived problems , and self-efficacy for restricting dietary sodium .
-RESULTS	Younger participants were more likely to report problems managing their hemodialysis diet and low self-efficacy for restricting sodium intake .
-RESULTS	Consistent with these findings , younger participants had a higher median sodium intake and higher average adjusted interdialytic weight gain .
-RESULTS	Females reported more problems managing their diet .
-RESULTS	Race , time on dialysis , and perceived income adequacy did not seem to influence outcome measures .
-CONCLUSIONS	Our findings suggest that patients who are younger and female encounter more difficulty adhering to the hemodialysis regimen .
-CONCLUSIONS	Hence , there may be a need to individualize counseling and interventions for these individuals .
-CONCLUSIONS	Further investigation is needed to understand the independent effects of age and gender on adherence to hemodialysis dietary recommendations and perceived self-efficacy .
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-###25590926
-BACKGROUND	Ventricular and supraventricular premature complexes ( PC ) are frequent and usually symptomatic .
-BACKGROUND	According to a previous study , magnesium pidolate ( MgP ) administration to symptomatic patients can improve the PC density and symptoms .
-OBJECTIVE	To assess the late follow-up of that clinical intervention in patients treated with MgP or placebo .
-METHODS	In the first phase of the study , 90 symptomatic and consecutive patients with PC were randomized ( double-blind ) to receive either MgP or placebo for 30 days .
-METHODS	Monthly follow-up visits were conducted for 15 months to assess symptoms and control electrolytes .
-METHODS	24-hour Holter was performed twice , regardless of symptoms , or whenever symptoms were present .
-METHODS	In the second phase of the study , relapsing patients , who had received MgP or placebo ( crossing-over ) in the first phase , were treated with MgP according to the same protocol .
-RESULTS	Of the 45 patients initially treated with MgP , 17 ( 37.8 % ) relapsed during the 15-month follow-up , and the relapse time varied .
-RESULTS	Relapsing patients treated again had a statistically significant reduction in the PC density of 138.25 / hour ( p < 0.001 ) .
-RESULTS	The crossing-over patients reduced it by 247/hour ( p < 0.001 ) .
-RESULTS	Patients who did not relapse , had a low PC frequency ( 3 PC/hour ) .
-RESULTS	Retreated patients had a 76.5 % improvement in symptom , and crossing-over patients , 71.4 % .
-CONCLUSIONS	Some patients on MgP had relapse of symptoms and PC , indicating that MgP is neither a definitive nor a curative treatment for late follow-up .
-CONCLUSIONS	However , improvement in the PC frequency and symptoms was observed in the second phase of treatment , similar to the response in the first phase of treatment .
-
-###25831599
-OBJECTIVE	To compare the efficacy of an oscillating-rotating power toothbrush with a novel brush head incorporating angled CrissCross bristles ( Oral-B Pro 7000 SmartSeries and Oral-B CrossAction brush head ) versus a marketed sonic toothbrush ( Colgate ProClinical A1500 with the Triple Clean brush head ) in the reduction of gingivitis and plaque over a 6-week period .
-METHODS	This was a single center , randomized , open label , examiner-blind , 2-treatment , parallel group study .
-METHODS	Study participants who met the entrance criteria were enrolled in the study and randomly assigned to one of the two toothbrush groups .
-METHODS	Study participants brushed with their assigned toothbrush and a marketed fluoride dentifrice for 2 minutes twice daily at home for 6 weeks .
-METHODS	Gingivitis and plaque were evaluated at baseline and Week 6 .
-METHODS	Gingivitis was assessed using the Modified Gingival Index ( MGI ) and Gingival Bleeding Index ( GBI ) and plaque was assessed using the Rustogi Modified Navy Plaque Index ( RMNPI ) .
-METHODS	Data was analyzed using the ANCOVA with baseline as the covariate .
-RESULTS	In total , 130 study participants were randomized to treatment resulting in 64 study participants per group completing the study .
-RESULTS	Both brushes produced statistically significant ( P < 0.001 ) reductions in gingivitis and plaque measures relative to baseline .
-RESULTS	The oscillating-rotating , brush with the novel brush head demonstrated statistically significantly ( P < 0.05 ) greater reductions in all gingivitis measures , as well as whole mouth and interproximal plaque measures , compared to the sonic toothbrush .
-RESULTS	The benefit for the oscillating - rotating brush over the sonic brush was 21.3 % for gingivitis , 35.7 % for gingival bleeding , 34.7 % for number of bleeding sites , 17.4 % for whole mouth plaque , and 21.2 % for interproximal plaque .
-RESULTS	There were no adverse events reported or observed for either brush .
-
-###25084784
-BACKGROUND	Value of information analysis has been proposed as an alternative to the standard hypothesis testing approach , which is based on type I and type II errors , in determining sample sizes for randomized clinical trials .
-BACKGROUND	However , in addition to sample size calculation , value of information analysis can optimize other aspects of research design such as possible comparator arms and alternative follow-up times , by considering trial designs that maximize the expected net benefit of research , which is the difference between the expected cost of the trial and the expected value of additional information .
-OBJECTIVE	To apply value of information methods to the results of a pilot study on catheter securement devices to determine the optimal design of a future larger clinical trial .
-METHODS	An economic evaluation was performed using data from a multi-arm randomized controlled pilot study comparing the efficacy of four types of catheter securement devices : standard polyurethane , tissue adhesive , bordered polyurethane and sutureless securement device .
-METHODS	Probabilistic Monte Carlo simulation was used to characterize uncertainty surrounding the study results and to calculate the expected value of additional information .
-METHODS	To guide the optimal future trial design , the expected costs and benefits of the alternative trial designs were estimated and compared .
-RESULTS	Analysis of the value of further information indicated that a randomized controlled trial on catheter securement devices is potentially worthwhile .
-RESULTS	Among the possible designs for the future trial , a four-arm study with 220 patients/arm would provide the highest expected net benefit corresponding to 130 % return-on-investment .
-RESULTS	The initially considered design of 388 patients/arm , based on hypothesis testing calculations , would provide lower net benefit with return-on-investment of 79 % .
-CONCLUSIONS	Cost-effectiveness and value of information analyses were based on the data from a single pilot trial which might affect the accuracy of our uncertainty estimation .
-CONCLUSIONS	Another limitation was that different follow-up durations for the larger trial were not evaluated .
-CONCLUSIONS	The value of information approach allows efficient trial design by maximizing the expected net benefit of additional research .
-CONCLUSIONS	This approach should be considered early in the design of randomized clinical trials .
-
-###24251386
-OBJECTIVE	To conduct a cost-effectiveness analysis comparing two different tooth replacement strategies for partially dentate older patients , namely partial removable dental prostheses ( RDP ) and functionally orientated treatment based on the shortened dental arch concept ( SDA ) .
-METHODS	Ninety-two partially dentate older patients completed a randomized controlled clinical trial .
-METHODS	Patients were randomly allocated to two treatment groups : the RDP group and the SDA group .
-METHODS	Treatment effect was measured using impact on oral health-related quality of life ( OHrQOL ) , and the costs involved in providing and maintaining care were recorded for all patients .
-METHODS	Patients were followed for 12 months after treatment intervention .
-METHODS	All treatment was provided by a single operator .
-RESULTS	The total cost of achieving the minimally important clinical difference ( MID ) in OHrQOL for an average patient in the RDP group was 464.64 .
-RESULTS	For the SDA group , the cost of achieving the MID for an average patient was 252.00 .
-RESULTS	The cost-effectiveness ratio was therefore 1:1.84 in favour of SDA treatment .
-CONCLUSIONS	With an increasingly ageing population , many patients will continue to benefit from removable prostheses to replace their missing natural teeth .
-CONCLUSIONS	From a purely economic standpoint , the results from this analysis suggest that the treatment of partially dentate older adults should be focused on functionally orientated treatment because it is simply more cost-effective .
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-###24615684
-BACKGROUND	Previous reports suggest that adherence to patching is a major issue in amblyopia treatment .
-BACKGROUND	We tested with an unmasked randomised controlled clinical trial whether an intense educational/motivational intervention improves adherence when a high-dose regime is prescribed .
-METHODS	62 children with newly diagnosed amblyopia were randomly allocated into two treatment arms with and without educational/motivational intervention material .
-METHODS	Both were prescribed patching 10 h/day , 6 days/week for a fixed period of 12 weeks .
-METHODS	The intervention arm received an educational/motivational intervention before patching which included information booklets , video , a cartoon story book , sticker charts and a dedicated session with a researcher .
-METHODS	The control arm received the usual clinical information .
-METHODS	The primary outcome measure was adherence measured using electronic occlusion dose monitors where a success/failure binary outcome was used to account for participants who dropped out of the study defined as patching > 4 h/day .
-METHODS	Visual outcome , expressed as percentage visual deficit , was measured as secondary outcome .
-RESULTS	The intervention increased adherence success rate from 45.2 % in the control group to 80.6 % in the intervention group ( p = 0.0027 ) .
-RESULTS	However , visual outcome was not significantly better in the intervention group ( p = 0.190 ) .
-CONCLUSIONS	Our study shows that an intense educational/motivational intervention can improve adherence to patching to high prescribed doses although no significant improvement in visual outcome was observed .
-CONCLUSIONS	TRIALS REGISTRATION NUMBER : ISRCTN05346737 ( International Standard Randomised Controlled Trial Number Register ) .
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-###24934646
-BACKGROUND	Currently , there is an increased prevalence of diabetes mellitus among the elderly .
-BACKGROUND	To minimize adverse effects on glycemic control , prevention and management of general and oral complications in diabetic patients is essential .
-BACKGROUND	The purpose of the present study is to assess the effectiveness of a Lifestyle Change plus Dental Care ( LCDC ) program to improve glycemic and periodontal status in the elderly with type 2 diabetes .
-METHODS	A quasi-experimental study was conducted in Health Centers 54 ( intervention ) and 59 ( control ) from October 2013 to January 2014.66 diabetic patients per health center were included .
-METHODS	At baseline , the intervention group attended a 20 minute lifestyle and oral health education program , individual lifestyle counseling using motivational interviewing ( MI ) , application of self regulation manual , and individual oral hygiene instruction .
-METHODS	The intervention group received booster education every visit by viewing a 15 minute educational video .
-METHODS	The control group received a routine program .
-METHODS	Participants were assessed at baseline and 3 month follow up for glycosylated hemoglobin ( HbA1c ) , fasting plasma glucose ( FPG ) , body mass index ( BMI ) , periodontal status , knowledge , attitude and practice of oral health and diabetes mellitus .
-METHODS	Data were analyzed by using descriptive statistic , Chi-square test , Fisher 's exact test , t-test , and multiple linear regression .
-RESULTS	After the 3 month follow up , a multiple linear regression analysis showed that the intervention group was significantly negatively correlated in both glycemic and periodontal status .
-RESULTS	Participants in the intervention group had significantly lower glycosylated hemoglobin ( HbA1c ) , fasting plasma glucose ( FPG ) , plaque index score , gingival index score , pocket depth , clinical attachment level ( CAL ) , and percentage of bleeding on probing ( BOP ) when compared to the control group .
-CONCLUSIONS	The combination of lifestyle change and dental care in one program improved both glycemic and periodontal status in the elderly with type 2 diabetes .
-BACKGROUND	ClinicalTrials.in.th : TCTR20140602001 .
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-###24596005
-OBJECTIVE	The aim of this study is to evaluate the effects of hormone replacement therapy using dienogest and medroxyprogesterone acetate on psychological symptoms in perimenopausal and postmenopausal women .
-METHODS	A total of 73 patients who sought treatment at the menopause units of the authors ' gynecology and obstetrics clinics between of November 2003 and October 2004 complaining of vasomotor symptoms were included in the study prospectively .
-METHODS	The cases were divided into two groups : Group I ( 37 patients ) was given 2 mg estradiol valerate and 2 mg dienogest , and Group II ( 36 patients ) was given 2 mg estradiol valerate and 10 mg medroxyprogesterone acetate .
-METHODS	The groups ' results in months 0 and 6 were compared through the evaluation of vasomotor and psychological symptom levels .
-RESULTS	No significant difference was found between the groups when the initial levels of vasomotor and psychological symptom subtypes were compared ( p = 0.16 ) .
-RESULTS	It was observed that all the psychological symptoms decreased in the 6th month in the group using dienogest in comparison with the initial situation , and that psychological symptoms increased in the group using medroxyprogesterone acetate in the evaluation performed in the 6th month compared with the initial levels .
-RESULTS	It was also found out that there was a statistically significant difference between the two groups when compared in terms of these symptoms ( p < 0.0001 ) .
-CONCLUSIONS	While the use of dienogest normalizes the general psychological situation and sleep , it was observed that the use of medroxyprogesterone acetate ( MPA ) worsens the general psychological situation .
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-###25329583
-BACKGROUND	Cross-sectional and retrospective studies have associated major depressive disorder with glial activation and injury as well as blood-brain barrier disruption , but these associations have not been assessed prospectively .
-BACKGROUND	Here , we aimed to determine the relationship between changes in depressive symptom severity and in blood levels of S-100 calcium-binding protein B ( S-100B ) , high-sensitivity C-reactive protein , and interleukin-6 following an inflammatory challenge .
-METHODS	Fifty unselected participants were recruited from a randomized , controlled trial comparing coronary artery bypass grafting procedures performed with versus without cardiopulmonary bypass for the risk of neurocognitive decline .
-METHODS	Depressive symptom severity was measured at baseline , discharge , and six-month follow-up using the Beck Depression Inventory II ( BDI-II ) .
-METHODS	The primary outcome of the present biomarker study was acute change in depressive symptom severity , defined as the intra-subject difference between baseline and discharge BDI-II scores .
-METHODS	Blood biomarker levels were determined at baseline and 2 days postoperative .
-RESULTS	Changes in S-100B levels correlated positively with acute changes in depressive symptom severity ( Spearman , 0.62 ; P = 0.0004 ) and accounted for about one-fourth of their observed variance ( R2 , 0.23 ; P = 0.0105 ) .
-RESULTS	This association remained statistically significant after adjusting for baseline S-100B levels , age , weight , body-mass index , or - blocker use , but not baseline BDI-II scores ( P = 0.064 ) .
-RESULTS	There was no statistically significant association between the primary outcome and baseline S-100B levels , baseline high-sensitivity C-reactive protein or interleukin-6 levels , or changes in high-sensitivity C-reactive protein or interleukin-6 levels .
-RESULTS	Among most participants , levels of all three biomarkers were normal at baseline and markedly elevated at 2 days postoperative .
-CONCLUSIONS	Acute changes in depressive symptom severity were specifically associated with incremental changes in S-100B blood levels , largely independent of covariates associated with either .
-CONCLUSIONS	These findings support the hypothesis that glial activation and injury and blood-brain barrier disruption can be mechanistically linked to acute exacerbation of depressive symptoms in some individuals .
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-###25126027
-BACKGROUND	We hypothesized that untreated severe obstructive sleep apnea ( OSA ) is associated with elevated ambulatory blood pressure ( BP ) in subjects with high cardiovascular disease ( CVD ) risk despite medical management .
-METHODS	Data from the baseline examination of the Heart Biomarker Evaluation in Apnea Treatment ( HeartBEAT ) study , a 4-site randomized controlled trial were analyzed .
-METHODS	Individuals with moderate-severe OSA ( apnea hypopnea index , AHI = 15-50 ) and cardiovascular risk were recruited from cardiology practices .
-METHODS	Those with hypertension were included .
-METHODS	Intensive antihypertensive regimen ( IAR ) was defined as 3 antihypertensives including a diuretic .
-METHODS	Definitions were : controlled BP ( BP < 130/80 ) , uncontrolled elevated BP ( BP 130/80 not on IAR ) and resistant elevated BP ( BP 130/80 mm Hg despite IAR ) .
-METHODS	Associations of untreated severe OSA ( AHI 30 ) and uncontrolled and resistant elevated BP were evaluated using logistic regression analyses adjusted for age , sex , race , body mass index , smoking status , diabetes , and CVD .
-RESULTS	Among the 284 participants ( mean age 63.1 7.2 years , 23.6 % with severe OSA ) , 61.6 % had controlled BP , 28.5 % had uncontrolled elevated BP , and 9.9 % had resistant elevated BP .
-RESULTS	Among participants prescribed IAR , resistant elevated BP was more prevalent in those with severe compared to moderate OSA ( 58.3 % vs. 28.6 % , p = 0.01 ) .
-RESULTS	Participants with severe OSA had a 4-fold higher adjusted odds of resistant elevated BP ( OR 4.1 , 95 % CI : 1.7-10 .2 ) , a finding not reproduced in the absence of IAR use .
-CONCLUSIONS	Among patients with increased cardiovascular risk and moderate to severe OSA , untreated severe compared to moderate OSA was associated with elevated BP despite IAR suggesting untreated severe OSA contributes to poor BP control despite aggressive medication use .
-CONCLUSIONS	A commentary on this article appears in this issue on page 845 .
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-###24632316
-BACKGROUND	The aim of this study is to explore the efficacy and safety of the combination of autologous transplantation of granulocyte colony-stimulating factor ( G-CSF ) - mobilized peripheral blood mononuclear cells ( PBMNCs ) and Panax notoginseng saponins ( PNS ) in the treatment of unreconstructable critical limb ischemia ( CLI ) .
-METHODS	We performed an open-label , parallel-group , single-center , randomized clinical trial in this study .
-METHODS	A total of 52 patients were enrolled and randomly divided into 2 groups ( the PBMNC + PNS group and the PBMNC group ) in a 1:1 ratio .
-METHODS	Evaluation variables , including changes in the ankle-brachial index ( ABI ) of ischemic limbs , ulcer area , severity of rest pain , transcutaneous oxygen pressure ( T ( C ) PO2 ) , and 6-min walk distance from baseline to week 8 and 16 , as well as angiographic scores for new collateral vessel formation at week 16 , were used to compare the benefits of these 2 treatment approaches .
-RESULTS	After 16 weeks of treatment , improvement in ABI , T ( C ) PO2 , and 6-min walk distance was significantly better in the PBMNC + PNS group .
-RESULTS	In addition , the combination of PBMNC transplantation and PNS administration yielded a greater reduction in ulcer area and severity of rest pain than did PBMNC transplantation alone .
-RESULTS	The proportion of patients experiencing any adverse event was similar between both treatment groups .
-RESULTS	Adverse events caused by PBMNC transplantation or PNS were generally mild and no serious adverse events occurred throughout the entire period of study .
-CONCLUSIONS	A combination of PNS and PBMNC transplantation appears to be a safe and effective treatment for patients with unreconstructable CLI .
-CONCLUSIONS	This combination may have great potential advantages in comparison with PBMNC transplantation alone and might constitute a novel therapeutic option for unreconstructable CLI .
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-###24977755
-BACKGROUND	Bone marrow ( BM ) dysfunction is common in severely injured trauma patients , resulting from elevated catecholamines and plasma granulocyte colony-stimulating factor ( G-CSF ) as well as prolonged mobilization of hematopoietic progenitor cells ( HPCs ) .
-BACKGROUND	We have previously shown that propranolol ( - blocker [ BB ] ) reduces HPC mobilization in a rodent model of injury and hemorrhagic shock .
-BACKGROUND	We hypothesize that BB would prevent BM dysfunction in humans following severe injury .
-METHODS	Forty-five severely injured trauma patients were studied in a prospective , randomized pilot trial .
-METHODS	Twenty-five patients received BB , and 20 served as untreated controls .
-METHODS	The dose of propranolol was adjusted to decrease the heart rate by 10 % to 20 % from baseline .
-METHODS	Blood was analyzed for the presence of HPC ( blast-forming unit erythroid cells [ BFU-E ] and colony-forming unit erythroid cells ) and G-CSF .
-METHODS	Demographic data , Injury Severity Score ( ISS ) , hemoglobin , reticulocyte number , and outcome data were obtained .
-RESULTS	The mean age of the study population was 33 years ; 87 % were male , with a mean ISS of 29 .
-RESULTS	There is a significant increase in BFU-E in peripheral blood immediately following traumatic injury , and this mobilization persists for 30 days .
-RESULTS	The use of BB significantly decreases BFU-E and colony-forming unit erythroid cells at all time points .
-RESULTS	G-CSF is significantly elevated in both groups on admission ; the use of BB decreases G-CSF levels by 51 % as compared with 37 % for controls .
-RESULTS	The average hemoglobin is nearly 1 g higher on the day of discharge with propranolol treatment ( BB , 9.9 0.4 g/dL vs. no BB , 9.1 0.6 g/dL ) .
-CONCLUSIONS	Following severe trauma , early treatment with propranolol following resuscitation is safe .
-CONCLUSIONS	The use of propranolol blunts early tachycardia , reduces HPC mobilization , and results in a faster return to baseline of the G-CSF peak seen after injury .
-CONCLUSIONS	There is also a trend toward faster recovery and resolution of anemia .
-CONCLUSIONS	Propranolol may be the first therapeutic agent to show improved BM function after severe injury .
-METHODS	Therapeutic study , level III .
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-###25213157
-BACKGROUND	Despite evidence for the effectiveness of structured psychological therapies for bipolar disorder no psychological interventions have been specifically designed to enhance personal recovery for individuals with recent-onset bipolar disorder .
-OBJECTIVE	A pilot study to assess the feasibility and effectiveness of a new intervention , recovery-focused cognitive-behavioural therapy ( CBT ) , designed in collaboration with individuals with recent-onset bipolar disorder intended to improve clinical and personal recovery outcomes .
-METHODS	A single , blind randomised controlled trial compared treatment as usual ( TAU ) with recovery-focused CBT plus TAU ( n = 67 ) .
-RESULTS	Recruitment and follow-up rates within 10 % of pre-planned targets to 12-month follow-up were achieved .
-RESULTS	An average of 14.15 h ( s.d. = 4.21 ) of recovery-focused CBT were attended out of a potential maximum of 18 h. Compared with TAU , recovery-focused CBT significantly improved personal recovery up to 12-month follow-up ( Bipolar Recovery Questionnaire mean score 310.87 , 95 % CI 75.00-546 .74 ( s.e. = 120.34 ) , P = 0.010 , d = 0.62 ) and increased time to any mood relapse during up to 15 months follow-up ( 2 = 7.64 , P < 0.006 , estimated hazard ratio ( HR ) = 0.38 , 95 % CI 0.18-0 .78 ) .
-RESULTS	Groups did not differ with respect to medication adherence .
-CONCLUSIONS	Recovery-focused CBT seems promising with respect to feasibility and potential clinical effectiveness .
-CONCLUSIONS	Clinical - and cost-effectiveness now need to be reliably estimated in a definitive trial .
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-###24289224
-OBJECTIVE	Tofacitinib is a novel , oral Janus kinase inhibitor being investigated for psoriasis .
-OBJECTIVE	This study assessed the relationship between pruritus and clinical signs of psoriasis ( assessed by Physician 's Global Assessment [ PGA ] ) in patients with moderate-to-severe chronic plaque psoriasis receiving tofacitinib .
-METHODS	In this 16-week ( 12-week treatment period , 4-week observation period ) , double-blind , placebo-controlled , phase IIb study ( NCT00678210 ) , 197 patients were randomized to tofacitinib 2 , 5 or 15 mg BID , or placebo .
-METHODS	Pruritus was patient assessed using the Itch Severity Score ( ISS ) , a 0-10 ( 10 = worst itching ) rating scale recorded daily from baseline to week 2 and at study visits .
-METHODS	Mediation modeling was used to determine relationships between ISS ( average score weeks 2-12 ) , PGA ( average score weeks 2-12 ) and treatment groups .
-RESULTS	Mediation analysis showed that 70.2-80 .5 % ( p < 0.001 versus placebo ) of tofacitinib 's effect on pruritus was direct , and mostly independent of improvements in erythema , induration and scaling .
-RESULTS	ISS measurements had acceptable test-retest reliability .
-RESULTS	Correlation analyses with clinical outcomes supported the validity of the ISS as a pruritus measure .
-CONCLUSIONS	Tofacitinib has a direct , beneficial effect on patient-reported pruritus independent from improvements in clinician-reported psoriasis severity signs .
-CONCLUSIONS	The ISS demonstrated favorable psychometric characteristics , supporting its use as a pruritus assessment tool .
-
-###24533897
-BACKGROUND	Despite the widespread recognition that obesity in pregnant women is associated with adverse outcomes for mother and child , there is no intervention proven to reduce the risk of these complications .
-BACKGROUND	The primary aim of this randomised controlled trial is to assess in obese pregnant women , whether a complex behavioural intervention , based on changing diet ( to foods with a lower glycemic index ) and physical activity , will reduce the risk of gestational diabetes ( GDM ) and delivery of a large for gestational age ( LGA ) infant .
-BACKGROUND	A secondary aim is to determine whether the intervention lowers the long term risk of obesity in the offspring .
-METHODS	Multicentre randomised controlled trial comparing a behavioural intervention designed to improve glycemic control with standard antenatal care in obese pregnant women.Inclusion criteria ; women with a BMI 30 kg/m2 and a singleton pregnancy between 15 +0 weeks and 18 +6 weeks ' gestation .
-METHODS	Exclusion criteria ; pre-defined , pre-existing diseases and multiple pregnancy .
-METHODS	Randomisation is on-line by a computer generated programme and is minimised by BMI category , maternal age , ethnicity , parity and centre .
-METHODS	Intervention ; this is delivered by a health trainer over 8 sessions .
-METHODS	Based on control theory , with elements of social cognitive theory , the intervention is designed to improve maternal glycemic control .
-METHODS	Women randomised to the control arm receive standard antenatal care until delivery according to local guidelines .
-METHODS	All women have a 75 g oral glucose tolerance test at 27 +0 - 28 +6 weeks ' gestation.Primary outcome ; Maternal : diagnosis of GDM , according to the International Association of Diabetes in Pregnancy Study Group ( IADPSG ) criteria .
-METHODS	Neonatal ; infant LGA defined as > 90th customised birth weight centile.Sample size ; 1546 women to provide 80 % power to detect a 25 % reduction in the incidence of GDM and a 30 % reduction in infants large for gestational age .
-CONCLUSIONS	All aspects of this protocol have been evaluated in a pilot randomised controlled trial , with subsequent optimisation of the intervention .
-CONCLUSIONS	The findings of this trial will inform whether lifestyle mediated improvement of glycemic control in obese pregnant women can minimise the risk of pregnancy complications .
-BACKGROUND	Current controlled trials ; ISRCTN89971375 .
-
-###25269512
-OBJECTIVE	Animal-assisted therapy ( AAT ) , most frequently used with dogs , is being used increasingly as an adjunctive alternative treatment for psychiatric patients .
-OBJECTIVE	AAT with larger animals , such as horses , may have unique benefits .
-OBJECTIVE	In this randomized controlled study , equine and canine forms of AAT were compared with standard treatments for hospitalized psychiatric patients to determine AAT effects on violent behavior and related measures .
-METHODS	The study included 90 patients with recent in-hospital violent behavior or highly regressed behavior .
-METHODS	Hospitalization at the 500-bed state psychiatric hospital was two months or longer ( mean 5.4 years ) .
-METHODS	Participants were randomly selected to receive ten weekly group therapy sessions of standardized equine-assisted psychotherapy ( EAP ) , canine-assisted psychotherapy ( CAP ) , enhanced social skills psychotherapy , or regular hospital care .
-METHODS	Participants ' mean age was 44 , 37 % were female , 76 % had diagnoses of schizophrenia or schizoaffective disorder , and 56 % had been committed involuntarily for civil or forensic reasons .
-METHODS	Violence-related incident reports filed by staff in the three months after study intake were compared with reports two months preintake .
-RESULTS	Interventions were well tolerated .
-RESULTS	Analyses revealed an intervention group effect ( F = 3.00 , df = 3 and 86 , p = .035 ) ; post hoc tests showed specific benefits of EAP ( p < .05 ) .
-RESULTS	Similar AAT effects were found for the incidence of 1:1 clinical observation ( F = 2.70 , df = 3 and 86 , p = .051 ) ; post hoc tests suggested benefits of CAP ( p = .058 ) as well as EAP ( p = .082 ) .
-RESULTS	Covariance analyses indicated that staff can predict which patients are likely to benefit from EAP ( p = .01 ) .
-CONCLUSIONS	AAT , and perhaps EAP uniquely , may be an effective therapeutic modality for long-term psychiatric patients at risk of violence .
-
-###25635977
-OBJECTIVE	Knowledge about the inhibition of centrally located angiotensin-I ( AT-I ) receptors by highly lipophilic AT-I receptor blockers and its ' effect are limited with experimental studies .
-OBJECTIVE	Thus , we aimed to investigate the effect of Telmisartan on Inter-dialytic weight gain ( IDWG ) % and echocardiographic measurements in anuric hemodialysis ( HD ) patients .
-METHODS	A total of forty-one anuric HD patients with 6 months maintenance on HD were included in this prospective , randomized and self-controlled study .
-METHODS	Four weeks prior the study , angiotensin converting enzyme blockers and AT-I receptor blocker drugs were stopped .
-METHODS	Patients were assessed three times during the study protocol .
-METHODS	These are baseline , three months later ( without Telmisartan period ) and three months after Telmisartan therapy .
-RESULTS	IDWG % was significantly decreased in the period of with Telmisartan compared to period without Telmisartan ( 5.6 1.0 % vs 5.3 1.0 % , p = 0.03 ) .
-RESULTS	After the administration of Telmisartan left ventricule end-diastolic diameter ( LVEDD ) ( p = 0.001 ) and inferior vena cava diameter ( IVCD ) ( 19.1 3.8 mm vs 17.3 4.2 mm , p = 0.001 ) were significantly decreased compared to the period of without Telmisartan .
-RESULTS	Despite of significantly changes observed in IVCD and LVEDD measurements in a period without Telmisartan , there was no significantly difference in left ventricular mass index ( LVMI ) measurements in this period .
-RESULTS	However , LVMI was significantly regressed after the administration of Telmisartan ( 269.3 82.7 g vs 256.3 70.3 g , p = 0.003 respectively ) .
-CONCLUSIONS	Treatment of anuric HD patients with Telmisartan at a dose of 40 mg a day reduces IDWG % , LVEDD and IVCD measurements .
-CONCLUSIONS	Further studies investigating the long-term effect of these beneficial effects on clinical outcomes are necessary .
-
-###25086653
-BACKGROUND	There are currently no serum biomarkers capable of distinguishing elevations in serum alanine aminotransferase ( ALT ) that portend serious liver injury potential from benign elevations such as those occurring during cholestyramine treatment .
-BACKGROUND	The aim of the research was to test the hypothesis that newly proposed biomarkers of hepatotoxicity would not significantly rise in serum during elevations in serum ALT associated with cholestyramine treatment , which has never been associated with clinically relevant liver injury .
-METHODS	In a double-blind placebo-controlled trial , cholestyramine ( 8g ) was administered for 11 days to healthy adult volunteers .
-METHODS	Serum from subjects with elevations in alanine aminotransferase ( ALT ) exceeding three-fold the upper limit of normal ( ULN ) were utilized for biomarker quantification .
-RESULTS	In 11 of 67 subjects , cholestyramine treatment resulted in ALT elevation by > 3x ULN ( mean 6.9 fold ; range 3-28 fold ) .
-RESULTS	In these 11 subjects , there was a 22.4-fold mean increase in serum levels of miR-122 relative to baseline , supporting a liver origin of the serum ALT .
-RESULTS	Significant elevations were noted in mean levels of necrosis biomarkers sorbitol dehydrogenase ( 8.1 fold ) , cytokeratin 18 ( 2.1 fold ) and HMGB1 ( 1.7 fold ) .
-RESULTS	Caspase-cleaved cytokeratin 18 , a biomarker of apoptosis was also significantly elevated ( 1.7 fold ) .
-RESULTS	A rise in glutamate dehydrogenase ( 7.3 fold ) may support mitochondrial dysfunction .
-CONCLUSIONS	All toxicity biomarkers measured in this study were elevated along with ALT , confirming the liver origin and reflecting both hepatocyte necrosis and apoptosis .
-CONCLUSIONS	Since cholestyramine treatment has no clinical liver safety concerns , we conclude that interpretation of the biomarkers studied may not be straightforward in the context of assessing liver safety of new drugs .
-
-###24622367
-BACKGROUND	Type 2 diabetes can often be prevented by lifestyle modification ; however , successful lifestyle intervention programmes are labour intensive .
-BACKGROUND	Mobile phone messaging is an inexpensive alternative way to deliver educational and motivational advice about lifestyle modification .
-BACKGROUND	We aimed to assess whether mobile phone messaging that encouraged lifestyle change could reduce incident type 2 diabetes in Indian Asian men with impaired glucose tolerance .
-METHODS	We did a prospective , parallel-group , randomised controlled trial between Aug 10 , 2009 , and Nov 30 , 2012 , at ten sites in southeast India .
-METHODS	Working Indian men ( aged 35-55 years ) with impaired glucose tolerance were randomly assigned ( 1:1 ) with a computer-generated randomisation sequence to a mobile phone messaging intervention or standard care ( control group ) .
-METHODS	Participants in the intervention group received frequent mobile phone messages compared with controls who received standard lifestyle modification advice at baseline only .
-METHODS	Field staff and participants were , by necessity , not masked to study group assignment , but allocation was concealed from laboratory personnel as well as principal and co-investigators .
-METHODS	The primary outcome was incidence of type 2 diabetes , analysed by intention to treat .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT00819455 .
-RESULTS	We assessed 8741 participants for eligibility .
-RESULTS	537 patients were randomly assigned to either the mobile phone messaging intervention ( n = 271 ) or standard care ( n = 266 ) .
-RESULTS	The cumulative incidence of type 2 diabetes was lower in those who received mobile phone messages than in controls : 50 ( 18 % ) participants in the intervention group developed type 2 diabetes compared with 73 ( 27 % ) in the control group ( hazard ratio 064 , 95 % CI 045-092 ; p = 0015 ) .
-RESULTS	The number needed to treat to prevent one case of type 2 diabetes was 11 ( 95 % CI 6-55 ) .
-RESULTS	One patient in the control group died suddenly at the end of the first year .
-RESULTS	We recorded no other serious adverse events .
-CONCLUSIONS	Mobile phone messaging is an effective and acceptable method to deliver advice and support towards lifestyle modification to prevent type 2 diabetes in men at high risk .
-BACKGROUND	The UK India Education and Research Initiative , the World Diabetes Foundation .
-
-###24616335
-OBJECTIVE	We studied the unclear question whether blood pressure ( BP ) lowering reduces cardiovascular disease ( CVD ) in elderly individuals with systolic BP < 160 mm Hg .
-RESULTS	We initiated a randomized placebo-controlled stratified 2 2 factorial clinical trial evaluating the effects of BP lowering in 11 000 elderly individuals with systolic blood pressure ( SBP ) between 130 and 159 mm Hg , for 5 years .
-RESULTS	Following 5-week active run-in , participants were randomized to aliskiren ( 300 mg ) or placebo , and to an additional antihypertensive [ hydrochlorothiazide ( 25 mg ) or amlodipine ( 5 mg ) ] , or their respective placeboes .
-RESULTS	Study was terminated by sponsor after 1759 subjects ( age 72.1 5.2 years , 88 % receiving at least one antihypertensive ) were randomized and followed for 0.6 year .
-RESULTS	Study drugs were well tolerated with few serious adverse events during run-in and after randomization , with no significant differences between treatment groups .
-RESULTS	By design , three levels of BP reductions were achieved , adjusted mean BP reductions of 3.5 / 1.7 mm Hg ( P < 0.001 ) by aliskiren , 6.8 / 3.3 mm Hg ( P < 0.001 ) by hydrochlorothiazide or amlodipine , and 10.3 / 5.0 mm Hg ( P < 0.001 ) by double therapy compared with placebo .
-RESULTS	Twenty-five major CVD events occurred .
-RESULTS	Non-significant trends towards fewer CVD events with greater BP reductions are evident : hazard ratios ( HR ) 0.82 [ 95 % confidence interval ( CI ) : 0.37-1 .81 ] for 3.5 mm Hg SBP reduction ; HR 0.45 ( 95 % CI : 0.19-1 .04 ) for 6.8 mm Hg ; and HR 0.25 ( 0.05-1 .18 ) for 10.3 mm Hg reduction for primary composite of CV death , MI , stroke , or significant heart failure .
-CONCLUSIONS	Sizeable reductions in BP , with potential for substantial CVD reduction , can be safely achieved using combinations of BP drugs in the elderly with normal high and Stage 1 hypertension .
-BACKGROUND	NCT01259297 .
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-###24684456
-BACKGROUND	As a result of research suggesting increased health risk with low serum 25-hydroxycholecalciferol ( 25 ( OH ) D ) , health care providers are measuring it frequently .
-BACKGROUND	Providers and patients are faced with treatment choices when low status is identified .
-OBJECTIVE	To compare the safety and efficacy of three vitamin D3 dietary supplements with different delivery matrices .
-METHODS	A 12-week , parallel group , single-masked , clinical trial was conducted in Seattle , Washington and Kailua Kona , Hawaii .
-METHODS	Sixty-six healthy adults with ( 25 ( OH ) D ) < 33 ng/mL were randomly assigned to take one of three D3 supplements , ie , a chewable tablet ( TAB ) , an oil-emulsified drop ( DROP ) , or an encapsulated powder ( CAP ) at a label-claimed dose of 10,000 IU/day .
-METHODS	Actual D3 content was assessed by a third party and the results adjusted based on the actual D3 content administered .
-METHODS	Mean change in 25 ( OH ) D/mcg D3 administered ; difference in the proportion of D3 insufficient participants ( ie , 25 ( OH ) D 30 ng/mL ) reaching sufficiency ( ie , 25 ( OH ) D 30 ng/mL ) ; and mean change in serum 1 , 25-dihydroxycholecalciferol were measured .
-RESULTS	In two of the three products tested , the measured vitamin D3 content varied considerably from the label-claimed dose .
-RESULTS	Differences in 25 ( OH ) D/mcg D3 administered were significantly different between groups ( P = .04 ; n = 55 ) .
-RESULTS	Pairwise comparisons demonstrated DROP resulted in a greater increase than TAB ( P < .05 ) but not than CAP .
-RESULTS	TAB was not different from CAP .
-RESULTS	The proportions reaching sufficiency were : 100 % ( TAB and CAP ) and 80 % ( DROP ) ( P = .03 between groups ; n = 55 ) .
-RESULTS	1 , 25-Dihydroxycholecalciferol did not change significantly in any group .
-CONCLUSIONS	Oil-emulsified vitamin D3 supplements resulted in a greater mean change in serum 25 ( OH ) D concentration , but fewer patients reaching vitamin D sufficiency , than chewable or encapsulated supplements .
-
-###24569031
-BACKGROUND	In the REPAIR-AMI trial , intracoronary infusion of bone marrow-derived cells ( BMCs ) was associated with a significantly greater recovery of contractile function in patients with acute myocardial infarction ( AMI ) at 4-month follow-up than placebo infusion .
-BACKGROUND	The current analysis investigates clinical outcome and predictors of event-free survival at 5 years .
-RESULTS	In the multicentre , placebo-controlled , double-blind REPAIR-AMI trial , 204 patients received intracoronary infusion of BMCs ( n = 101 ) or placebo ( n = 103 ) into the infarct vessel 3-7 days following successful percutaneous coronary intervention .
-RESULTS	Fifteen patients died in the placebo group compared with seven patients in the BMC group ( P = 0.08 ) .
-RESULTS	Nine placebo-treated patients and five BMC-treated patients required rehospitalization for chronic heart failure ( P = 0.23 ) .
-RESULTS	The combined endpoint cardiac/cardiovascular/unknown death or rehospitalisation for heart failure was more frequent in the placebo compared with the BMC group ( 18 vs. 10 events ; P = 0.10 ) .
-RESULTS	Univariate predictors of adverse outcomes were age , the CADILLAC risk score , aldosterone antagonist and diuretic treatment , changes in left ventricular ejection fraction , left ventricular end-systolic volume , and N-terminal pro-Brain Natriuretic Peptide ( all P < 0.01 ) at 4 months in the entire cohort and in the placebo group .
-RESULTS	In contrast , in the BMC group , only the basal ( P = 0.02 ) and the stromal cell-derived factor-1-induced ( P = 0.05 ) migratory capacity of the administered BMC were associated with improved clinical outcome .
-CONCLUSIONS	In patients of the REPAIR-AMI trial , established clinical parameters are associated with adverse outcome at 5 years exclusively in the placebo group , whereas the migratory capacity of the administered BMC determines event-free survival in the BMC-treated patients .
-CONCLUSIONS	These data disclose a potency-effect relationship between cell therapy and long-term outcome in patients with AMI .
-
-###25423041
-BACKGROUND	Xpert MTB/RIF is approved for use in tuberculosis ( TB ) and rifampicin-resistance diagnosis .
-BACKGROUND	However , data are limited on the impact of Xpert under routine conditions in settings with high TB burden .
-RESULTS	A pragmatic prospective cluster-randomised trial of Xpert for all individuals with presumptive ( symptomatic ) TB compared to the routine diagnostic algorithm of sputum microscopy and limited use of culture was conducted in a large TB/HIV primary care clinic .
-RESULTS	The primary outcome was the proportion of bacteriologically confirmed TB cases not initiating TB treatment by 3 mo after presentation .
-RESULTS	Secondary outcomes included time to TB treatment and mortality .
-RESULTS	Unblinded randomisation occurred on a weekly basis .
-RESULTS	Xpert and smear microscopy were performed on site .
-RESULTS	Analysis was both by intention to treat ( ITT ) and per protocol .
-RESULTS	Between 7 September 2010 and 28 October 2011 , 1,985 participants were assigned to the Xpert ( n = 982 ) and routine ( n = 1,003 ) diagnostic algorithms ( ITT analysis ) ; 882 received Xpert and 1,063 routine ( per protocol analysis ) .
-RESULTS	13 % ( 32/257 ) of individuals with bacteriologically confirmed TB ( smear , culture , or Xpert ) did not initiate treatment by 3 mo after presentation in the Xpert arm , compared to 25 % ( 41/167 ) in the routine arm ( ITT analysis , risk ratio 0.51 , 95 % CI 0.33-0 .77 , p = 0.0052 ) .
-RESULTS	The yield of bacteriologically confirmed TB cases among patients with presumptive TB was 17 % ( 167/1 ,003 ) with routine diagnosis and 26 % ( 257/982 ) with Xpert diagnosis ( ITT analysis , risk ratio 1.57 , 95 % CI 1.32-1 .87 , p < 0.001 ) .
-RESULTS	This difference in diagnosis rates resulted in a higher rate of treatment initiation in the Xpert arm : 23 % ( 229/1 ,003 ) and 28 % ( 277/982 ) in the routine and Xpert arms , respectively ( ITT analysis , risk ratio 1.24 , 95 % CI 1.06-1 .44 , p = 0.013 ) .
-RESULTS	Time to treatment initiation was improved overall ( ITT analysis , hazard ratio 0.76 , 95 % CI 0.63-0 .92 , p = 0.005 ) and among HIV-infected participants ( ITT analysis , hazard ratio 0.67 , 95 % CI 0.53-0 .85 , p = 0.001 ) .
-RESULTS	There was no difference in 6-mo mortality with Xpert versus routine diagnosis .
-RESULTS	Study limitations included incorrect intervention allocation for a high proportion of participants and that the study was conducted in a single clinic .
-CONCLUSIONS	These data suggest that in this routine primary care setting , use of Xpert to diagnose TB increased the number of individuals with bacteriologically confirmed TB who were treated by 3 mo and reduced time to treatment initiation , particularly among HIV-infected participants .
-BACKGROUND	Pan African Clinical Trials Registry PACTR201010000255244 .
-BACKGROUND	Please see later in the article for the Editors ' Summary .
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-###25336730
-BACKGROUND	Circumsporozoite protein ( CS ) is the antigenic target for RTS , S , the most advanced malaria vaccine to date .
-BACKGROUND	Heterologous prime-boost with the viral vectors simian adenovirus 63 ( ChAd63 ) - modified vaccinia virus Ankara ( MVA ) is the most potent inducer of T-cells in humans , demonstrating significant efficacy when expressing the preerythrocytic antigen insert multiple epitope-thrombospondin-related adhesion protein ( ME-TRAP ) .
-BACKGROUND	We hypothesized that ChAd63-MVA containing CS may result in a significant clinical protective efficacy .
-METHODS	We conducted an open-label , 2-site , partially randomized Plasmodium falciparum sporozoite controlled human malaria infection ( CHMI ) study to compare the clinical efficacy of ChAd63-MVA CS with ChAd63-MVA ME-TRAP .
-RESULTS	One of 15 vaccinees ( 7 % ) receiving ChAd63-MVA CS and 2 of 15 ( 13 % ) receiving ChAd63-MVA ME-TRAP achieved sterile protection after CHMI .
-RESULTS	Three of 15 vaccinees ( 20 % ) receiving ChAd63-MVA CS and 5 of 15 ( 33 % ) receiving ChAd63-MVA ME-TRAP demonstrated a delay in time to treatment , compared with unvaccinated controls .
-RESULTS	In quantitative polymerase chain reaction analyses , ChAd63-MVA CS was estimated to reduce the liver parasite burden by 69 % -79 % , compared with 79 % -84 % for ChAd63-MVA ME-TRAP .
-CONCLUSIONS	ChAd63-MVA CS does reduce the liver parasite burden , but ChAd63-MVA ME-TRAP remains the most promising antigenic insert for a vectored liver-stage vaccine .
-CONCLUSIONS	Detailed analyses of parasite kinetics may allow detection of smaller but biologically important differences in vaccine efficacy that can influence future vaccine development .
-BACKGROUND	NCT01623557 .
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-###24333157
-OBJECTIVE	The purpose of the study was to compare behavioral outcomes ( physical activity , sedentary behavior , smoking cessation , diet ) between the intervention and usual care conditions from the TEAMcare trial .
-METHODS	TEAMcare was a randomized trial among 214 adults with depression and poorly controlled diabetes and/or coronary heart disease that promoted health behavior change and pharmacotherapy to improve health .
-METHODS	Behavioral outcomes were measured with the International Physical Activity Questionnaire ( physical activity , sitting time ) and the Summary of Diabetes Self-Care Activities Measure ( smoking , diet , exercise ) .
-METHODS	Poisson regression models among completers ( N = 185 ) were conducted adjusting for age , education , smoking status and depression .
-RESULTS	Intervention participants had more days/week following a healthy eating plan [ relative rate = 1.2 , 95 % confidence interval ( CI ) = 1.1-1 .4 ] and more days of participation in 30 min of physical activity ( relative rate = 1.2 , 95 % CI = 1.1-2 .0 ) compared to usual care .
-RESULTS	Intervention participants were more likely to meet physical activity guidelines ( 7.5 % increase ) compared to usual care ( 12 % decrease ; P = .053 ) .
-CONCLUSIONS	Diet and activity generally improved for those receiving the intervention , while there were no differences in some aspects of diet ( fruit and vegetable and high-fat food intake ) , smoking status and sitting time between conditions in the TEAMcare trial .
-
-###25252721
-BACKGROUND	The 2010 American Heart Association guidelines suggested an increase in cardiopulmonary resuscitation compression depth with a target > 50 mm and no upper limit .
-BACKGROUND	This target is based on limited evidence , and we sought to determine the optimal compression depth range .
-RESULTS	We studied emergency medical services-treated out-of-hospital cardiac arrest patients from the Resuscitation Outcomes Consortium Prehospital Resuscitation Impedance Valve and Early Versus Delayed Analysis clinical trial and the Epistry-Cardiac Arrest database .
-RESULTS	We calculated adjusted odds ratios for survival to hospital discharge , 1-day survival , and any return of circulation .
-RESULTS	We included 9136 adult patients from 9 US and Canadian cities with a mean age of 67.5 years , mean compression depth of 41.9 mm , and a return of circulation of 31.3 % , 1-day survival of 22.8 % , and survival to hospital discharge of 7.3 % .
-RESULTS	For survival to discharge , the adjusted odds ratios were 1.04 ( 95 % CI , 1.00-1 .08 ) for each 5-mm increment in compression depth , 1.45 ( 95 % CI , 1.20-1 .76 ) for cases within 2005 depth range ( > 38 mm ) , and 1.05 ( 95 % CI , 1.03-1 .08 ) for percentage of minutes in depth range ( 10 % change ) .
-RESULTS	Covariate-adjusted spline curves revealed that the maximum survival is at a depth of 45.6 mm ( 15-mm interval with highest survival between 40.3 and 55.3 mm ) with no differences between men and women .
-CONCLUSIONS	This large study of out-of-hospital cardiac arrest patients demonstrated that increased cardiopulmonary resuscitation compression depth is strongly associated with better survival .
-CONCLUSIONS	Our adjusted analyses , however , found that maximum survival was in the depth interval of 40.3 to 55.3 mm ( peak , 45.6 mm ) , suggesting that the 2010 American Heart Association cardiopulmonary resuscitation guideline target may be too high .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00394706 .
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-###24494277
-OBJECTIVE	To compare the efficacy differences between acupuncture combined with auricular point sticking therapy and clomiphene oral administration in the treatment of polycystic ovary syndrome ( PCOS ) .
-METHODS	One hundred cases of PCOS were randomized into two groups , 50 cases in each one .
-METHODS	Acupuncture com bined with auricular point sticking group ( group A ) : acupuncture was applied at Guanyuan ( CV 4 ) , Zhongji ( CV 3 ) and Zigong ( EX-CA 1 ) , once daily ; auricular point sticking was applied at Spleen ( pi , CO13 ) , Endocrine ( neifenmi , CO18 ) , Unterus and Kidney ( shen , CO10 ) , t he plaster was changed once a week .
-METHODS	Clomiphene grou p ( group B ) : oral clomiphene was prescribed at the 5th day of the menstrual , for 5 consecutive days , totally 3 menstrual cycles was needed .
-METHODS	The ovulation induction , pregnancy and menstruation resuming of patients in the two ' , The totally effective rate was 90.00 % ( 45/50 ) in group A , which was group were observed and compared .
-RESULTS	The totally effective rate was 90.0 % ( 45/50 ) in group A , which was superior to 86.0 % ( 43/50 ) in group B ( P < 0.05 ) ; the ovulation rate and pregnancy rate were 68.0 % ( 34/50 ) and 64.0 % ( 32/50 ) in group A , whiche were superior to that of group B ( all P < 0.05 ) ; the menstruation resuming rate was 94.00 ( 47/50 ) in group A , which was superior to 88.00 ( 44/50 ) in group B ( P < 0.05 ) .
-RESULTS	No adverse effect was observed in group A , while in group B , varying degrees of nausea , vomiting , headache and dermatitis were observed in 29 cases , ovarian hyperstimulation syndrome ( OHSS ) like polycystic ovary was observed in 14 cases under the B ultrasound .
-CONCLUSIONS	Acupuncture combined with auricular point sticking therapy has a better effect than clomiphene in the treatment of PCOS without any adverse effect .
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-###24315572
-BACKGROUND	Former sleep studies among non-treatment seeking chronic cocaine users had captured polysomnographic changes for as long as three weeks of abstinence .
-METHODS	20 cocaine dependent participants , randomized to placebo in an ongoing clinical trial , received 12 days of inpatient substance abuse treatment followed by 6 weeks of outpatient cognitive behavioral therapy .
-METHODS	Polysomnographic recording was performed on consecutive nights during the 1st and 2nd inpatient and 3rd and 6th outpatient weeks .
-METHODS	Number of days abstinent was determined from thrice weekly urine toxicology and self-report .
-METHODS	Polysomnographic sleep was compared between study week 1 and 2 , using paired t-tests .
-METHODS	Trajectory of total sleep time ( TST ) was modeled both as a linear and a quadratic function of days abstinent .
-RESULTS	Despite reporting an improvement in overall sleep quality , polysomnographic sleep worsened from week 1 to 2 .
-RESULTS	Among all participants , TST and stage 2 sleep time decreased , while REM sleep latency increased .
-RESULTS	Among participants who began the study with a positive urine test , there was also a decrease in REM and a trend for decreased slow wave sleep .
-RESULTS	TST compared to number of days abstinent ( up to 54 days ) was best fit with a quadratic model ( p = 0.002 ) , suggesting the possibility of an improvement in total sleep time with extended abstinence .
-CONCLUSIONS	This is the first polysomnographic characterization of sleep in a large sample of cocaine users in treatment .
-CONCLUSIONS	Present findings confirm earlier results of poor and deteriorating sleep early in abstinence , and raise the possibility of improvement after an extended abstinence .
-
-###25695686
-OBJECTIVE	Assessment of differences in soft tissue healing and long-term issues between two techniques for bone-anchored hearing implant ( BAHI ) surgery .
-METHODS	Single-center , randomized , nonblinded study using balanced randomization ( 1:1 ) .
-METHODS	Tertiary referral center in the Central Denmark Region .
-METHODS	Forty-seven adults with normal skin quality .
-METHODS	Operation with a BAHI system with randomization to 1 ) dermatome technique with soft tissue removal and 2 ) linear incision with no soft tissue reduction .
-METHODS	Holgers ' score , pain , and sensibility loss assessed at 0 , 3 , 7 , 10 , 14 , and 21 days and 1 , 3 , 6 , and 12 months postoperatively .
-METHODS	Implant loss .
-RESULTS	Forty-nine patients were randomized ( linear incision , n = 25 ; dermatome , n = 24 ) .
-RESULTS	Forty-seven patients were analyzed ( linear incision , n = 25 ; dermatome , n = 22 ) .
-RESULTS	Differences in proportions for grouped data ( outcome 0 and outcome > 0 ) for the total of all visits were Holgers ' Index : 0.13 ( p = 0.0004 ; 95 % confidence interval [ 95 % CI ] , 0.058-0 .21 ) ; sensibility loss : 0.50 ( p = 2.2 10 ; 95 % CI , 0.42-0 .58 ) ; pain : 0.096 ( p = 0.006 ; 95 % CI , 0.026-0 .17 ) .
-RESULTS	Soft tissue reactions and pain were most prominent in the early postoperative period , whereas issues with sensibility loss subsided throughout the 1-year follow-up period .
-RESULTS	No implants were lost .
-CONCLUSIONS	In a randomized trial for BAHI surgery , the linear incision with no subcutaneous reduction had a faster healing time and inflicted less pain and sensibility loss than the dermatome technique .
-CONCLUSIONS	The long-term soft tissue problems were similar in the two groups , thus favoring the linear incision , which is less invasive .
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-###25047649
-OBJECTIVE	The combined IVGTT-hyperinsulinaemic-euglycaemic clamp ( Botnia clamp ) allows the assessment of insulin secretion and sensitivity in one experiment .
-OBJECTIVE	It remains unclear whether this clamp yields results comparable with those of the standard hyperinsulinaemic-euglycaemic clamp ( SHEC ) in diabetes patients .
-OBJECTIVE	We hypothesised that the IVGTT induces responses affecting insulin sensitivity assessment .
-METHODS	Of 22 randomised diet - or metformin-treated patients with well-controlled type 2 diabetes , 19 randomly underwent a Botnia clamp and an SHEC , spaced by 2 weeks , in one clinical research centre in a crossover study .
-METHODS	The main outcomes were whole-body and hepatic insulin sensitivity as measured by the clamp and [ 6,6 - ( 2 ) H2 ] glucose .
-METHODS	Substrate utilisation was assessed from indirect calorimetry and beta cell function from insulin dynamics during IVGTT .
-RESULTS	The values of whole-body insulin sensitivity obtained from Botnia clamp and SHEC were correlated ( r = 0.87 , p < 0.001 ) , but also revealed intra-individual variations .
-RESULTS	Hepatic insulin sensitivity did not differ between experiments during the clamp , but differed after IVGTT .
-RESULTS	The contribution of glucose oxidation to glucose disposal increased by 2.2 0.3 and 1.2 0.4 mg kg fat-free mass ( FFM ) ( -1 ) min ( -1 ) ( Botnia and SHEC , p < 0.05 ) , whereas lipid oxidation decreased by 0.8 0.1 and 0.4 0.1 mg kg FFM ( -1 ) min ( -1 ) ( p < 0.05 ) from baseline .
-RESULTS	Differences in NEFA ( r = -0.60 , p < 0.01 ) , but not C-peptide ( r = -0.16 , p = 0.52 ) or hepatic insulin sensitivity between IVGTT and placebo before the clamps correlated with individual variations of insulin sensitivity .
-CONCLUSIONS	The Botnia clamp provides similar estimates of insulin sensitivity as SHEC in patients with type 2 diabetes , but changes in NEFA during IVGTT may affect insulin sensitivity and thereby the discrimination between insulin-sensitive and insulin-resistant individuals .
-BACKGROUND	ClinicalTrials.gov NCT01397279 FUNDING : The study was funded by the Ministry of Science and Research of the State of North Rhine-Westphalia and the German Federal Ministry of Health , and supported in part by grants from the Federal Ministry for Research to the Centers for Diabetes Research , Helmholtz Alliance Imaging and Curing Environmental Metabolic Diseases and the Schmutzler-Stiftung .
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-###25194408
-BACKGROUND	Clinical studies of recent years have shown that hyperuricemia is associated with poor outcomes such as cardiovascular mortality and dialysis inadequacy in patients undergoing hemodialysis .
-BACKGROUND	Our study investigated the effect of vitamin C supplementation on serum uric acid levels in hemodialysis patients .
-METHODS	This randomized placebo-controlled trial was conducted on 172 hemodialysis patients .
-METHODS	They were randomly divided into the intervention group , to receive 250 mg of vitamin C , three times per week , for 8 weeks , and control groups 1 and 2 , to receive placebo injection ( saline ) and no intervention , respectively .
-METHODS	Serum levels of uric acid and creatinine were measured at the start of the study and also after 8 weeks .
-RESULTS	The mean of serum levels of uric acid was 6.02 1.08 mg/dL ( reference range , 2.6 mg/dL to 6 mg/dL ) .
-RESULTS	Nearly , half of the patients ( 46.7 % ) had a serum level of uric acid greater than 6 mg/dL .
-RESULTS	The median baseline serum levels of uric acid were 6.2 mg/dL , 5.9 mg/dL , and 6 mg/dL in the intervention , control 1 , and control 2 groups , respectively ( P = .19 ) .
-RESULTS	After 2 months , median levels reduced significantly in the vitamin C group to 5.8 mg/dL as compared to 6.4 mg/dL and 6.3 mg/dL in control groups ( P = .02 ) .
-RESULTS	The mean serum creatinine level had no significant changes during the study .
-CONCLUSIONS	Our results demonstrated the existence of a significant negative relationship between vitamin C and serum uric acid levels .
-CONCLUSIONS	Detailed investigations with larger sample sizes and longer-term use of vitamin C are recommended .
-
-###25535985
-OBJECTIVE	This prospective long-term follow-up study evaluated the effects of half-dose etanercept ( 25 mg weekly ) on clinical remission and radiographic progression in a large cohort of patients with rheumatoid arthritis ( RA ) in clinical remission after etanercept 25 mg bi-weekly .
-METHODS	524 biologic-nave RA patients were treated with etanercept 25 mg bi-weekly after failure of conventional drugs .
-METHODS	Patients achieving remission ( DAS28 < 2.6 ) for 12 months were randomised to receive etanercept 25 mg weekly or 25 mg bi-weekly .
-METHODS	Patients were assessed at baseline and every 12 weeks .
-METHODS	Remission rates , radiographic progression , incidence of infections and costs of the regimens were compared .
-RESULTS	After a mean follow-up of 1811 months , 347 patients ( 66.2 % ) achieved DAS28 remission ; 323 were randomised to one of two dose regimens : etanercept 25 weekly ( group A , 159 patients ) and etanercept 25 mg bi-weekly ( group B , 164 patients ) .
-RESULTS	At the end of follow-up , 81.8 % patients of group A maintained remission for a mean of 3.61.5 years .
-RESULTS	Radiographic progression occurred in a small number of patients of group A and the rate of radiographic progression ( TSS > 0 ) was not significantly different in the two groups ( 18.85 % vs. 19.0 % after the first year and 16.9 % vs. 21.6 % after the second year , respectively ) .
-RESULTS	The incidence ratio of severe infections was 2.3 / 1.000 patient-years in group A. Etanercept half-dose regimen resulted in a saving of 3.190.545 with a cost saving up to 827.318 per year .
-CONCLUSIONS	Clinical remission and arrest of radiographic progression persisted in a substantial percentage of patients with RA even after reduction of standard-dose etanercept .
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-###24318410
-BACKGROUND	Acute appendicitis is the most common reason for abdominal surgery in young adults and children .
-BACKGROUND	Open appendectomy is still the treatment often chosen because it is simple , safe , and effective .
-BACKGROUND	Our aim was to study whether cosmetic results of appendectomy wounds are better after using continuous absorbable intradermal ( A ) sutures compared with wound closure with interrupted nonabsorbable ( NA ) sutures .
-METHODS	A total of 206 adult patients with clinically suspected appendicitis were allocated to the study and prospectively randomized into two wound-closure groups : the interrupted NA suture group and the A suture group .
-METHODS	Of these , 193 patients with sufficient data were invited to the outpatient clinic for cosmetic analysis .
-METHODS	Cosmetic results were evaluated after a median of 14 months .
-METHODS	For subjective scar assessment , the Vancouver scar scale , the patient and observer scar assessment scale ( POSAS ) , and a visual analog scale ( VAS ) were used .
-METHODS	Objective evaluation was carried out by measuring surface area , average width , and estimated concentration change ( ECC ) of hemoglobin and melanin in the scar using spectrocutometry .
-METHODS	For statistical analyses we used the Mann-Whitney test and Student 's t test .
-RESULTS	Both objective and subjective analyses showed better cosmetic results for absorbable intradermal suturing .
-RESULTS	The difference between the two groups was statistically significant as regards POSAS in both patient ( p = 0.032 ) and observer scales ( p = 0.001 ) , and VAS ( p = 0.002 ) .
-RESULTS	Scar surface area was significantly smaller in group A than in group NA ( p = 0.002 ) .
-RESULTS	ECC measurements showed higher values for melanin in group NA than in group A ( p = 0.034 ) .
-CONCLUSIONS	Continuous intradermal absorbable suturing yields a better cosmetic result than interrupted nonabsorbable suturing in lower abdominal transverse appendectomy .
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-###24445098
-OBJECTIVE	We investigated 3 approaches for implementing the Chronic Care Model to improve diabetes care : ( 1 ) practice facilitation over 6 months using a reflective adaptive process ( RAP ) approach ; ( 2 ) practice facilitation for up to 18 months using a continuous quality improvement ( CQI ) approach ; and ( 3 ) providing self-directed ( SD ) practices with model information and resources , without facilitation .
-METHODS	We conducted a cluster-randomized trial , called Enhancing Practice , Improving Care ( EPIC ) , that compared these approaches among 40 small to midsized primary care practices .
-METHODS	At baseline and 9 months and 18 months after enrollment , we assessed practice diabetes quality measures from chart audits and Practice Culture Assessment scores from clinician and staff surveys .
-RESULTS	Although measures of the quality of diabetes care improved in all 3 groups ( all P < .05 ) , improvement was greater in CQI practices compared with both SD practices ( P < .0001 ) and RAP practices ( P < .0001 ) ; additionally , improvement was greater in SD practices compared with RAP practices ( P < .05 ) .
-RESULTS	In RAP practices , Change Culture scores showed a trend toward improvement at 9 months ( P = .07 ) but decreased below baseline at 18 months ( P < .05 ) , while Work Culture scores decreased from 9 to 18 months ( P < .05 ) .
-RESULTS	Both scores were stable over time in SD and CQI practices .
-CONCLUSIONS	Traditional CQI interventions are effective at improving measures of the quality of diabetes care , but may not improve practice change and work culture .
-CONCLUSIONS	Short-term practice facilitation based on RAP principles produced less improvement in quality measures than CQI or SD interventions and also did not produce sustained improvements in practice culture .
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-###25240168
-OBJECTIVE	Intracoronary thrombus is disrupted by stent deployment and confounded by the development of intrastent plaque prolapse .
-OBJECTIVE	This study aims at investigating the feasibility and repeatability of thrombus quantification prior to stent implantation using optical coherence tomography ( OCT ) in ST-segment elevation myocardial infarction ( STEMI ) patients .
-RESULTS	Patients were enrolled in an OCT substudy of the TOTAL trial ( a randomized trial of routine aspiration ThrOmbecTomy with PCI vs. PCI ALone in patients with STEMI undergoing primary PCI ) of aspiration thrombectomy or percutaneous coronary intervention ( PCI ) alone in primary PCI ( PPCI ) of STEMI .
-RESULTS	Using OCT , thrombus burden ( TB ) and other measures of pre - and post-stent atherothrombus were analysed over the arterial segment defined by the final stent length .
-RESULTS	Feasibility was 86.2 % ( 25/29 patients ) for both pre - and post-stent OCT imaging .
-RESULTS	Altogether , 8111 OCT cross-sections were analysed .
-RESULTS	In Bland-Altman analyses of inter-observer variation ( n = 25 ) , the mean pre-stent TB was 8.76 % for Observer 1 and 8.97 % for Observer 2 ( limits of agreement -2.6 to 2.2 % ) .
-RESULTS	In Bland-Altman analyses of intra-observer variation ( n = 15 ) , the mean pre-stent TB was 8.06 % for the first and 7.35 % for the second round of analysis by Observer 1 ( limits of agreement -1.72 to 3.15 % ) .
-RESULTS	There was a good correlation between pre-stent TB and pre-stent quadrants with thrombus/mm ( r = 0.97 ) , but only modest correlation between pre-stent TB and post-stent atherothrombotic burden ( ATB ; r = 0.54 ) .
-CONCLUSIONS	Measurement of pre-stent TB by OCT during the PPCI of STEMI is feasible and highly repeatable .
-CONCLUSIONS	Pre-stent TB is only modestly correlated with post-stent ATB , which indicates that pre-stent measurements might be of additional value when assessing the TB in STEMI .
-
-###24866279
-OBJECTIVE	The aim of this study was to investigate the degree of correlation between the Pelvic Organ Quantification system ( POP-Q ) measurements and symptom questionnaire scores before and after surgery .
-OBJECTIVE	This was a part of a randomized controlled study comparing conventional colporrhaphy with mesh repair surgery .
-METHODS	The correlation between POP-Q measurements and Pelvic Floor Impact Questionnaire ( PFIQ-7 ) and Pelvic Floor Distress Inventory ( PFDI-20 ) scores was investigated in 164 women 55 years or older scheduled for primary anterior vaginal wall prolapse surgery at baseline and the correlation between the change in point Ba and scores following surgery .
-METHODS	Statistical analyses used McNemar 's and Wilcoxon signed-rank tests , Spearman 's rank-order correlation , and multiple linear regression .
-RESULTS	Surgery significantly improved POP-Q , PFIQ-7 , and PFDI-20 scores , including subscales .
-RESULTS	We observed weak correlations between POP-Q and PFIQ-7 , including subscales ( r 0.173-0 .324 , p < 0.05 ) , and PFDI-20 , including the Pelvic Organ Prolapse Distress Inventory ( POPDI ) subscale ( r 0.180-0 .211 , p < 0.05 ) .
-RESULTS	Regression analysis demonstrated a significant relationship between point Ba and PFIQ-7 ( p = 0.001 ) and PFDI-20 ( p = 0.04 ) , respectively .
-RESULTS	Furthermore , we observed a significant relationship between the change in point Ba ( following surgery ) and change in scores ; point Ba following surgery was significantly correlated with symptoms of bulging ( r = 0.303 , p < 0.01 ) and bladder-emptying problems ( r = 0.213 , p < 0.01 ) .
-CONCLUSIONS	The weak correlation between POP-Q and urogenital symptoms based on questionnaire scores suggests that neither scoring system is optimal .
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-###24393344
-BACKGROUND	Pressure ulcers are one of the most common health complaints , which often take months or years to heal , and affect patients ' morbidity and quality of life .
-BACKGROUND	Medical options for pressure ulcers are limited .
-BACKGROUND	Electroacupuncture ( EA ) has been employed to relieve the symptoms for patients with pressure ulcers , but there is limited clinical evidence for its effectiveness .
-METHODS	This study consists of a randomized controlled trial ( RCT ) with two parallel arms : a control group and an EA group .
-METHODS	Both groups will receive standard wound care ( including changing position , using mattresses and cushions , and a good diet ) of five sessions per week for a total of 40 sessions during the 8-week treatment period .
-METHODS	In addition , the EA group will receive the EA intervention .
-METHODS	The following outcome measurements will be used in examination of participants : wound surface area ( WSA ) , visual analogue scale ( VAS ) , and the proportion of ulcers healed within trial period ( PUHTP ) .
-METHODS	All the outcomes will be evaluated at the start of the study , at the end of the fourth week , at 8 weeks after randomization , and 1 month after treatment cessation .
-CONCLUSIONS	The aim of this study is to evaluate the effectiveness of EA for the treatment of patients with pressure ulcers .
-BACKGROUND	Chinese Clinical Trial Register : ChiCTR-TRC-11001693 .
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-###25190674
-OBJECTIVE	Although statins can induce coronary atheroma regression , this benefit has yet to be demonstrated in diabetic individuals .
-OBJECTIVE	We tested the hypothesis that high-intensity statin therapy may promote coronary atheroma regression in patients with diabetes .
-METHODS	The Study of Coronary Atheroma by Intravascular Ultrasound : Effect of Rosuvastatin Versus Atorvastatin ( SATURN ) used serial intravascular ultrasound measures of coronary atheroma volume in patients treated with rosuvastatin 40 mg or atorvastatin 80 mg for 24 months .
-METHODS	This analysis compared changes in biochemistry and coronary percent atheroma volume ( PAV ) in patients with ( n = 159 ) and without ( n = 880 ) diabetes .
-RESULTS	At baseline , patients with diabetes had lower LDL cholesterol ( LDL-C ) and HDL cholesterol ( HDL-C ) levels but higher triglyceride and CRP levels compared with patients without diabetes .
-RESULTS	At follow-up , diabetic patients had lower levels of LDL-C ( 61.0 20.5 vs. 66.4 22.9 mg/dL , P = 0.01 ) and HDL-C ( 46.3 10.6 vs. 49.9 12.0 mg/dL , P < 0.001 ) but higher levels of triglycerides ( 127.6 [ 98.8 , 163.0 ] vs. 113.0 mg/dL [ 87.6 , 151.9 ] , P = 0.001 ) and CRP ( 1.4 [ 0.7 , 3.3 ] vs. 1.0 [ 0.5 , 2.1 ] mg/L , P = 0.001 ) .
-RESULTS	Both patients with and without diabetes demonstrated regression of coronary atheroma as measured by change in PAV ( -0.83 0.13 vs. -1.15 0.13 % , P = 0.08 ) .
-RESULTS	PAV regression was less in diabetic compared with nondiabetic patients when on-treatment LDL-C levels were > 70 mg/dL ( -0.31 0.23 vs. -1.01 0.21 % , P = 0.03 ) but similar when LDL-C levels were 70 mg/dL ( -1.09 0.16 vs. -1.24 0.16 % , P = 0.50 ) .
-CONCLUSIONS	High-intensity statin therapy alters the progressive nature of diabetic coronary atherosclerosis , yielding regression of disease in diabetic and nondiabetic patients .
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-###25536736
-OBJECTIVE	To evaluate the effects of different intracorporeal ligation techniques with titanium clips , Plasma Trisector ( Gyrus , USA ) ( PTG ) , and surgical silk on bilateral laparoscopic varicocelectomy ( LPVx ) .
-METHODS	Between May 2009 and August 2012 , 100 patients who underwent bilateral LPVx were evaluated .
-METHODS	The demographic parameters of patients , preoperative radiological findings , semen analysis , operative data , and follow-up were recorded .
-METHODS	All of the patients were divided into 3 groups , randomized prospectively .
-METHODS	The patients whose veins were ligated by 5-mm titanium clips were included in group I , those whose veins were ligated by PTG were included in group II , and those whose veins were ligated by surgical silk were included in group III .
-METHODS	The recorded data of the groups were analyzed .
-RESULTS	Mean follow-up time was 18.8 + 1.1 months .
-RESULTS	According to the demographics of age , body mass index , spermiogram , and diameter of veins before surgery , there were no statistical differences between any of the groups ( P > 0.05 ) .
-RESULTS	However , operation time was longer in group III ( P < 0.0001 ) , while total numbers ofligated veins did not differ among the groups ( P > 0.05 ) .
-RESULTS	Additionally , hospital stay , oral intake , and complications were not different among the groups ( P > 0.05 ) .
-RESULTS	In follow-up the sperm count analysis was higher than the preoperative count analysis for all of the groups ( P < 0.05 ) .
-CONCLUSIONS	PTG may provide a shorter operation time than using titanium clips and/or surgical silk in LPVx .
-CONCLUSIONS	Additionally , PTG may increase sperm count with fewer complications than the other ligation techniques in LPVx .
-CONCLUSIONS	Therefore , PTG may be the new candidate electrosurgical standard device for LPVx in the nearby future .
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-###25230038
-OBJECTIVE	To compare the level of anxiety and performance of nursing students when performing a clinical simulation through the traditional method of assessment with the presence of an evaluator and through a filmed assessment without the presence of an evaluator .
-METHODS	Controlled trial with the participation of Brazilian public university 20 students who were randomly assigned to one of two groups : a ) assessment through the traditional method with the presence of an evaluator ; or b ) filmed assessment .
-METHODS	The level of anxiety was assessed using the Zung test and performance was measured based on the number of correct answers .
-RESULTS	Averages of 32 and 27 were obtained on the anxiety scale by the group assessed through the traditional method before and after the simulation , respectively , while the filmed group obtained averages of 33 and 26 ; the final scores correspond to mild anxiety .
-RESULTS	Even though there was a statistically significant reduction in the intra-groups scores before and after the simulation , there was no difference between the groups .
-RESULTS	As for the performance assessments in the clinical simulation , the groups obtained similar percentages of correct answers ( 83 % in the traditional assessment and 84 % in the filmed assessment ) without statistically significant differences .
-CONCLUSIONS	Filming can be used and encouraged as a strategy to assess nursing undergraduate students .
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-###24496455
-BACKGROUND	We aimed to evaluate whether oral anticoagulants ( OACs ) alter faecal immunochemical test ( FIT ) performance in average-risk colorectal cancer ( CRC ) screening .
-METHODS	Individuals aged 50-69 years were invited to receive one FIT sample ( cutoff 75 ng ml ( -1 ) ) between November 2008 and June 2011 .
-RESULTS	Faecal immunochemical test was positive in 9.3 % ( 21 out of 224 ) of users of OAC and 6.2 % ( 365 out of 5821 ) of non-users ( P-trend = 0.07 ) .
-RESULTS	The positive predictive value ( PPV ) for advanced neoplasia ( AN ) in non-users was 50.4 % vs 47.6 % in users ( odds ratio , 0.70 ; 95 % CI , 0.3-1 .8 ; P = 0.5 ) .
-RESULTS	The PPV for AN in OAC more antiplatelets ( aspirin or clopidogrel ) was 75 % ( odds ratio , 2 ; 95 % CI , 0.4-10 .8 ; P = 0.4 ) .
-CONCLUSIONS	Oral anticoagulant did not significantly modify the PPV for AN in this population-based colorectal screening program .
-CONCLUSIONS	The detection rate of advanced adenoma was higher in the combination OAC more antiplatelets .
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-###24738550
-BACKGROUND	Virtual patients ( VPs ) offer valuable alternative encounters when live patients with rare conditions , such as cranial nerve ( CN ) palsies , are unavailable ; however , little is known regarding simulation and optimal social learning context .
-OBJECTIVE	Compare learning outcomes and perspectives between students interacting with VPs in individual and team contexts .
-METHODS	Seventy-eight medical students were randomly assigned to interview and examine four VPs with possible CN damage either as individuals or in three-person teams , using Neurological Examination Rehearsal Virtual Environment ( NERVE ) .
-METHODS	Learning was measured through diagnosis accuracy and pre - / post-simulation knowledge scores .
-METHODS	Perspectives of learning context were collected post-simulation .
-RESULTS	Students in teams submitted correct diagnoses significantly more often than students as individuals for CN-IV ( p = 0.04 ; team = 86.1 % ; individual = 65.9 % ) and CN-VI ( p = 0.03 ; team = 97.2 % ; individual = 80.5 % ) .
-RESULTS	Knowledge scores increased significantly in both contexts ( p < 0.001 ) ; however , a significant aptitude-treatment interaction effect was observed ( p = 0.04 ) .
-RESULTS	At pre-test scores 25.8 % , students in teams scored significantly higher ( 66.7 % ) than students as individuals ( 43.1 % ) at post-test ( p = 0.03 ) .
-RESULTS	Students recommended implementing future NERVE exercises in teams over five other modality-timing combinations .
-CONCLUSIONS	Results allow us to define best practices for integrating VP simulators into medical education .
-CONCLUSIONS	Implementing NERVE experiences in team environments with medical students in the future may be preferable .
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-###25419883
-BACKGROUND	Exercise-induced cough ( EIC ) is frequently reported by winter athletes , but this symptom is not always associated with exercise-induced bronchoconstriction ( EIB ) .
-BACKGROUND	The aims of this study were to determine if EIC can be inhibited or reduced with the inhalation of ipratropium , and if EIC in winter athletes is associated with EIB .
-METHODS	On 2 visits , 24 cross-country skiers ( 10 males and 12 females , mean age 17 3 years ) performed an outdoor exercise in the winter ( 30-minute warm-up , followed by a 3-minute sprint ) , randomly preceded by the inhalation of ipratropium or a placebo .
-METHODS	A spirometry was done at baseline and 20 minutes after inhalation of ipratropium or placebo .
-METHODS	Exercise was then performed , followed by the measurement of forced expiratory volume in 1 second and the recording of the number of coughs until 60 minutes after exercise .
-METHODS	Before and after exercise , the perception of cough intensity was evaluated using a modified Borg scale .
-RESULTS	Twelve of 16 athletes who completed the study ( 75 % ) were symptomatic following exercise with placebo ( number of coughs 5 ) , but none developed EIB .
-RESULTS	For these athletes , the number of coughs after exercise ( mean number of coughs standard deviation : placebo , 26 14 ; ipratropium , 25 23 ; P value , nonsignificant ) and the maximal perception score for cough intensity ( mean Borg score standard deviation : placebo , 1.9 1.2 ; ipratropium , 2.0 1.1 ; P value , nonsignificant ) were not significantly different between ipratropium and placebo .
-RESULTS	A decrease in the number of coughs was observed in 6 of the symptomatic athletes and an increase was observed in the other 6 , resulting in a nonsignificant mean effect .
-CONCLUSIONS	Ipratropium does not appear to significantly influence the number and the perception of cough following exercise .
-CONCLUSIONS	Moreover , these results suggest that EIC is not mainly associated with EIB .
-CONCLUSIONS	However , a subgroup of athletes seems to show a beneficial response to ipratropium , suggesting different cough responses in this population .
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-###24408122
-OBJECTIVE	The Avosentan on Time to Doubling of Serum Creatinine , End Stage Renal Disease or Death ( ASCEND ) trial tested the renoprotective effect of the endothelin receptor antagonist avosentan in patients with diabetes and nephropathy , but the study was terminated due to an excess of congestive heart failure ( CHF ) events in the avosentan arms , likely due to fluid retention .
-OBJECTIVE	The aim of this study was to identify risk markers of CHF after treatment with avosentan .
-METHODS	In a post hoc analysis of the ASCEND trial ( N = 1392 participants ) , we assessed which baseline characteristics predicted CHF risk during avosentan treatment .
-METHODS	Furthermore , postrandomization changes between baseline and the first available measurement of body weight and hemoglobin were examined as potential clinical indicators of fluid retention for their relationship with CHF development .
-RESULTS	Relative to placebo , avosentan increased CHF risk ( hazard ratio , 2.76 ; 95 % confidence interval , 1.68 to 4.54 ) .
-RESULTS	The avosentan-related CHF risk was higher with lower baseline cholesterol levels ( P interaction = 0.003 ) and concomitant statin use ( P interaction = 0.06 ) , whereas it was lower with a lower estimated GFR ( P interaction = 0.04 ) .
-RESULTS	Patients allocated to avosentan had a median body weight increase of 0.6 kg ( interquartile range , 0.0 to 2.0 kg ) and a median hemoglobin decrease of 1.4 g/dl ( interquartile range , -2.1 to -0.7 g/dl ) at the first postrandomization measurement .
-RESULTS	The body weight increase induced by avosentan was associated with CHF development ( P interaction = 0.04 ) , whereas hemoglobin decrease was not ( P interaction = 0.64 ) .
-RESULTS	The increase in body weight was particularly pronounced in patients with a cardiovascular disease history and in patients using statins .
-CONCLUSIONS	In avosentan-treated patients , body weight increase , but not hemoglobin decrease , was associated with CHF development , indicating that close body weight monitoring could provide an early signal of CHF development in future trials with endothelin receptor antagonists .
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-###24681859
-OBJECTIVE	The aim of this study was to measure round window ( RW ) diameters in patients with congenital aural atresia ( CAA ) or sensorineural hearing loss ( SNHL ) and a normal control group and to analyze whether differences exist between these groups .
-METHODS	Temporal bone computed tomographic scans of 12 patients with CAA ( 5 males , 7 females ) aged 1 to 50 years ( median age , 6 years ) , 12 patients with SNHL ( 8 males , 4 females ) aged 2 to 32 years ( median age , 5 years ) , and 11 patients ( 3 males , 7 females ) aged 2 months to 53 years ( median age , 8 years ) randomly selected from a pool of patients with unilateral chronic otitis media or cholesteatoma were reviewed .
-METHODS	We measured RW diameter on oblique reconstruction planes .
-METHODS	To prevent possible individual differences , skull width was measured .
-RESULTS	There were no statistically significant differences between all groups for skull width .
-RESULTS	Both RW diameter and RW membrane width were found smaller in the CAA group than both SNHL group and control group with statistical significance , whereas there were no statistically significant differences between the SNHL group and the control group .
-CONCLUSIONS	We found that both the RW diameter and RW membrane width in CAA were smaller than those in the control group .
-CONCLUSIONS	If this finding is supported in future studies , the production of floating mass transducer with different sizes may be useful .
-CONCLUSIONS	We suggest that RW diameter should be measured in each patient before operation and thus a floating mass transducer with the appropriate caliber should be chosen .
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-###24428092
-BACKGROUND	New topical treatments studied in adults have been published to be potentially effective in the treatment of hypertrophic scar and keloids .
-BACKGROUND	There is still no study in Thai children .
-OBJECTIVE	To study the efficacy of 10 % onion extract in silicone derivative gel for the prevention of hypertrophic scar and keloid in median sternotomy wound from open heart surgery in pediatric patients .
-METHODS	Thirty-nine pediatric patients who had median sternotomy were recruited in this prospective randomized , double-blinded , placebo-controlled split-scar experimental study .
-METHODS	The wound in each patient was divided into upper and lower parts , and the treatment with , either onion extract gel or placebo was randomly applied by block randomization onto each part of the wound twice daily after the seventh day postoperatively for six months .
-METHODS	The incidence of scars , serial photographs of the wound , Vancouver Scar Scale ( VSS ) , and adverse effect were assessed at each visit .
-RESULTS	Thirty patients with the mean age of 4.3 years completed the 6-month study period .
-RESULTS	Six patients ( 20 % ) in onion extract gel group had no scar compared to one patient ( 3.3 % ) in placebo group ( p = 0.04 ) .
-RESULTS	Of the 27 patients with hypertrophic scar nine were from onion extract gel group and 18 from the placebo group ( p = 0.02 ) .
-RESULTS	Keloid was not statistically significant diferent in both groups ( p = 0.29 ) .
-RESULTS	VSS was not statistically significant different in all visits .
-RESULTS	One case had a pustule on the part of the onion extract in silicone derivative application at the sixth month .
-CONCLUSIONS	Onion extract in silicone derivative gel can significantly decreased the incidence of hypertrophic scar from median sternotomy wound in pediatric patients .
-CONCLUSIONS	Keloid did not show statistically significant differences in both groups .
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-###24782447
-OBJECTIVE	To investigate the characteristics of residual symptoms and to evaluate the effects of adjuvant vestibular suppressants on residual symptoms after successful canalith repositioning procedures ( CRPs ) .
-METHODS	Individual randomized controlled trial .
-METHODS	One hundred fifty patients with idiopathic benign paroxysmal positional vertigo who achieved successful CRPs on initial visit participated in this study .
-METHODS	Dizziness Handicap Inventory ( DHI ) questionnaires were completed before CRPs .
-METHODS	All study populations were divided into three groups after successful CRPs on the initial visit day : the medication ( V ) group ( treated with a vestibular suppressant [ dimenhydrinate 50 mg per day ] ) , the placebo ( P ) group , and the no medication ( N ) group .
-METHODS	One week after successful CRPs , residual symptoms were checked and repeated DHI questionnaires were completed to compare residual symptoms .
-RESULTS	Among the 138 patients who did not show positional nystagmus at follow-up , 67 ( 48.5 % ) complained of residual symptoms .
-RESULTS	The presence of residual symptoms was more prevalent in the P and N group compared with the V group ( P = .035 , P = .017 , respectively ) .
-RESULTS	The most frequent residual symptom was lightheadedness ( n = 42 ) .
-RESULTS	Moreover , in the V group , lightheadedness was significantly reduced compared with the P group ( P = .029 ) .
-RESULTS	However , in the analysis of DHI , total and subscale scores did not differ across the three groups before or after successful CRP .
-CONCLUSIONS	Vestibular suppressants significantly reduced residual symptoms compared to both placebo and no medication after CRP .
-CONCLUSIONS	However , there was no significant reduction in DHI score compared with the control group , suggesting that the residual symptoms could not be evaluated by DHI score alone .
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-###25907945
-OBJECTIVE	To study the effect of perioperative immunomodulatory therapy on postoperative recurrence of rectal cancer .
-METHODS	This prospective study was conducted among 238 rectal/anal cancer patients undergoing intersphincteric resection at our center between January , 2010 and January , 2011 , among whom 150 were eligible to be included and completed the study .
-METHODS	The 150 patients were randomized in a double-blinded fashion into 3 equal groups to receive immunomodulatory therapy with 8 mg/kg celecoxib ( group A ) , 0.4 mg/kg Sou-Medrol ( group B ) , or placebo ( group C ) , given daily from 5 days before surgery to 5 days after surgery , and the postoperative cancer recurrence were compared .
-RESULTS	At 3 days after the operation , the 3 groups showed significantly different C-reactive protein ( CRP ) levels , which decreased obviously in all the 3 groups compared with those at 1 day following the operation ( P = 0.022 ) , especially in group B.
-RESULTS	The levels of interleukin-6 ( IL-6 ) at 3 days after the operation also differed significantly between the 3 groups but were lower in all the 3 groups than those at 1 day after the operation ( P = 0.046 ) , and this reduction was the most obvious in group A. COX-2 expression differed significantly between the 3 groups ( P = 0.017 ) , among which group A showed the most obvious suppression of COX-2 expression .
-RESULTS	During the follow-up for a mean of 45 months , no significant difference in the recurrence rate was found between the 3 groups ( P = 0.549 ) .
-CONCLUSIONS	With a lower efficacy than Sou-Medrol in decreasing postoperative inflammation , celecoxib produces a better effect in inhibiting COX-2 expression , but it does not lower postoperative recurrence rate of rectal cancer .
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-###24405854
-BACKGROUND	In trials of behavioural interventions , the individuals who deliver the intervention are in a position of key influence on the success of the trial .
-BACKGROUND	Their fidelity to the intervention is crucial .
-BACKGROUND	Yet little is understood about the experiences of this group of trial personnel .
-BACKGROUND	This study aimed to investigate the views and experiences of educators who delivered a structured education intervention to people with type 2 diabetes , which incorporated training in self-monitoring of either blood glucose ( SMBG ) or urine glucose ( SMUG ) as part of a randomized controlled trial ( RCT ) .
-METHODS	Educators ' views were explored through focus groups before and after training ( N = 18 ) and approximately 1 year into the trial ( N = 14 ) , and semi-structured telephone interviews at approximately 2 years ( N = 7 ) .
-METHODS	Analysis was based on the constant comparative method .
-RESULTS	Educators held preferences regarding the intervention variants ; thus , they were not in individual equipoise .
-RESULTS	Training raised awareness of preferences and their potential to impact on delivery .
-RESULTS	Educators were confident in their unbiased delivery , but acknowledged the challenges involved .
-RESULTS	Concealing their preferences was helped by a sense of professionalism , the patient-centred nature of the intervention , and concessions in the trial protocol ( enabling participants to swap monitoring methods if needed ) .
-RESULTS	Commitment to unbiased delivery was explained through a desire for evidence-based knowledge in the contentious area of SMBG .
-CONCLUSIONS	The findings provide insight into a previously unexplored group of trial personnel -- intervention deliverers in trials of behavioural interventions -- which will be useful to those designing and running similar trials .
-CONCLUSIONS	Rather than individual equipoise , it is intervention deliverers ' awareness of personal preferences and their potential impact on the trial outcome that facilitates unbiased delivery .
-CONCLUSIONS	Further , awareness of community equipoise , the need for evidence , and relevance to the individual enhance commitment to the RCT .
-BACKGROUND	ISRCTN95696668 .
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-###25480457
-OBJECTIVE	The purpose of this study is to determine whether varying the format used to present prognostic data alters the perception of risk among surrogate decision makers in the intensive care unit ( ICU ) .
-METHODS	This was a prospective randomized comparative trial conducted in a 23-bed adult tertiary ICU .
-METHODS	Enrolled surrogate decision makers were randomized to 1 of 2 questionnaires , which presented hypothetical ICU scenarios , identical other than the format in which prognostic data were presented ( eg , frequencies vs percentages ) .
-METHODS	Participants were asked to rate the risk associated with each prognostic statement .
-RESULTS	We enrolled 141 surrogate decision makers .
-RESULTS	The perception of risk varied significantly dependent on the presentation format .
-RESULTS	For `` quantitative data , '' risks were consistently perceived as higher , when presented as frequencies ( eg , 1 in 50 ) compared with equivalent percentages ( eg , 2 % ) .
-RESULTS	Framing `` qualitative data '' in terms of chance of `` death '' rather than `` survival '' led to a statistically significant increase in perceived risks .
-RESULTS	Framing `` quantitative '' data in this way did not significantly affect risk perception .
-CONCLUSIONS	Data format had a significant effect on how surrogate decision makers interpreted risk .
-CONCLUSIONS	Qualitative statements are interpreted widely and affected by framing .
-CONCLUSIONS	Where possible , multiple quantitative formats should be used for presenting prognostic information .
-
-###24516645
-OBJECTIVE	The training response of an intensified period of high-intensity exercise is not clear .
-OBJECTIVE	Therefore , we compared the cardiovascular adaptations of completing 24 high-intensity aerobic interval training sessions carried out for either three or eight weeks , respectively .
-METHODS	Twenty-one healthy subjects ( 23.02.1 years , 10 females ) completed 24 high-intensity training sessions throughout a time-period of either eight weeks ( moderate frequency , MF ) or three weeks ( high frequency , HF ) followed by a detraining period of nine weeks without any training .
-METHODS	In both groups , maximal oxygen uptake ( VO2max ) was evaluated before training , at the 9 ( th ) and 17 ( th ) session and four days after the final 24 ( th ) training session .
-METHODS	In the detraining phase VO2max was evaluated after 12 days and thereafter every second week for eight weeks .
-METHODS	Left ventricular echocardiography , carbon monoxide lung diffusion transfer factor , brachial artery flow mediated dilatation and vastus lateralis citrate maximal synthase activity was tested before and after training .
-RESULTS	The cardiovascular adaptation after HF training was delayed compared to training with MF .
-RESULTS	Four days after ending training the HF group showed no improvement ( +3.0 % , p = 0.126 ) , whereas the MF group reached their highest VO2max with a 10.7 % improvement ( p < 0.001 : group difference p = 0.035 ) .
-RESULTS	The HF group reached their highest VO2max ( 6.1 % increase , p = 0.026 ) twelve days into the detraining period , compared to a concomitant reduction to 7.9 % of VO2max ( p < 0.001 ) above baseline in the MF group ( group difference p = 0.609 ) .
-CONCLUSIONS	Both HF and MF training of high-intensity aerobic exercise improves VO2max .
-CONCLUSIONS	The cardiovascular adaptation following a HF programme of high-intensity exercise is however delayed compared to MF training .
-BACKGROUND	ClinicalTrials.gov NCT00733941 .
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-###25301035
-OBJECTIVE	Impaired arterial function has been implicated in diabetes-related atherosclerosis , but its determinants in high-risk adults have not been well characterised .
-OBJECTIVE	We investigated factors associated with impaired arterial function in adults with type 2 diabetes .
-METHODS	Flow-mediated dilatation ( a marker of endothelial function ) and dilator response to glyceryl trinitrate ( to assess smooth muscle function ) of the brachial artery were assessed at baseline in 193 patients with type 2 diabetes from the Fenofibrate Intervention and Event Lowering in Diabetes ( FIELD ) study .
-METHODS	Traditional risk factors were assessed and a multivariable model was constructed to identify factors independently associated with impaired arterial function .
-RESULTS	Median age was 64 years ( interquartile range , 58-69 ; 61 % male ) and duration of diabetes was 4 years ( interquartile range , 2-9 ) .
-RESULTS	Flow-mediated dilatation ( 3.06 0.25 % , mean SEM ) was severely impaired but not significantly associated with other risk factors .
-RESULTS	Dilator responses to glyceryl trinitrate ( 10.56 0.52 % ) were significantly and independently impaired in past and present cigarette smokers ( P = 0.005 ) and in subjects with increased urinary albumin/creatinine ratio ( P = 0.01 ) .
-CONCLUSIONS	In adults with type 2 diabetes and known or suspected atherosclerosis , arterial smooth muscle-dependent dilatation was shown to be significantly impaired in cigarette smokers and those with elevated urinary albumin levels .
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-###25482242
-OBJECTIVE	To determine whether a home-based care coordination program focused on medication self-management would affect the cost of care to the Medicare program and whether the addition of technology , a medication-dispensing machine , would further reduce cost .
-METHODS	Randomized , controlled , three-arm longitudinal study .
-METHODS	Participant homes in a large Midwestern urban area .
-METHODS	Older adults identified as having difficulty managing their medications at discharge from Medicare Home Health Care ( N = 414 ) .
-METHODS	A team consisting of advanced practice nurses ( APNs ) and registered nurses ( RNs ) coordinated care for two groups : home-based nurse care coordination ( NCC ) plus a pill organizer group and NCC plus a medication-dispensing machine group .
-METHODS	To measure cost , participant claims data from 2005 to 2011 were retrieved from Medicare Part A and B Standard Analytical Files .
-RESULTS	Ordinary least squares regression with covariate adjustment was used to estimate monthly dollar savings .
-RESULTS	Total Medicare costs were $ 447 per month lower in the NCC plus pill organizer group ( P = .11 ) than in a control group that received usual care .
-RESULTS	For participants in the study at least 3 months , total Medicare costs were $ 491 lower per month in the NCC plus pill organizer group ( P = .06 ) than in the control group .
-RESULTS	The cost of the NCC plus pill organizer intervention was $ 151 per month , yielding a net savings of $ 296 per month or $ 3,552 per year .
-RESULTS	The cost of the NCC plus medication-dispensing machine intervention was $ 251 per month , and total Medicare costs were $ 409 higher per month than in the NCC plus pill organizer group .
-CONCLUSIONS	Nurse care coordination plus a pill organizer is a cost-effective intervention for frail elderly Medicare beneficiaries .
-CONCLUSIONS	The addition of the medication machine did not enhance the cost effectiveness of the intervention .
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-###24289887
-BACKGROUND	Numerous animal studies and clinical trials have demonstrated that erythropoietin ( EPO ) has therapeutic effects in ischemic and degenerative diseases .
-BACKGROUND	However , few clinical trials have investigated the effect of EPO in Parkinson 's disease ( PD ) patients .
-BACKGROUND	This study was an exploratory pilot study to investigate the effects of recombinant human EPO ( rhEPO ) on motor and non-motor symptoms ( NMS ) in PD patients .
-METHODS	A total of 26 PD patients at the Hanyang University Hospital were enrolled in the study .
-METHODS	The participants were randomly assigned to rhEPO and placebo groups .
-METHODS	The rhEPO group was infused intravenously ( 40,000 IU each ) twice a week for 5 weeks .
-METHODS	Clinical improvement was estimated using the Unified Parkinson 's Disease Rating Scale-III ( UPDRS-III ) , the NMS Scale ( NMSS ) and the 39-Item Parkinson 's Disease Questionnaire ( PDQ-39 ) .
-METHODS	[ ( 18 ) F ] N - ( 3-fluoropropyl ) -2 - carbon ethoxy-3 - ( 4-iodophenyl ) nortropane ( FP-CIT ) photon emission tomography ( PET ) scanning was performed on each participant at baseline and again after 12 months .
-RESULTS	The rhEPO administration significantly improved the NMSS and PDQ-39 scores at 12 months .
-RESULTS	The UPDRS-III , which reflects motor function , did not change significantly after the rhEPO treatment .
-RESULTS	With the NMSS , the domains of cardiovascular autonomic function , sleep/fatigue , mood/cognition and attention/memory showed significant changes .
-RESULTS	None of the participants experienced any serious adverse effects .
-CONCLUSIONS	We found that rhEPO had beneficial effects on NMS but not on motor function .
-CONCLUSIONS	Dopaminergic refractory NMS , such as cardiovascular autonomic dysfunction and cognition , showed improvement after the administration of rhEPO .
-CONCLUSIONS	Our results suggest that rhEPO might be a good candidate for the treatment of NMS in PD patients .
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-###24325386
-OBJECTIVE	In the present study , the potential benefits of oral carnitine in preventing antituberculosis drug-induced hepatotoxicity ( ATDH ) were evaluated .
-METHODS	Fifty-four patients in the carnitine and 62 patients in the placebo group completed the study .
-METHODS	The carnitine group received 1000mg oral carnitine solution twice daily for 4 weeks .
-METHODS	The placebo group received 10mL of oral placebo solution twice daily for 4 weeks .
-METHODS	ATDH was defined as an increase in the serum level of aspartate aminotransferase or alanine aminotransferase greater than three or five times of the upper limit of normal with or without clinical symptoms of hepatotoxicity , respectively .
-RESULTS	During the study period , 29 ( 25 % ) patients experienced ATDH .
-RESULTS	Among these patients , nine ( 16.7 % ) and 20 ( 32.3 % ) were in the carnitine and placebo groups , respectively ( P = 0.049 ) .
-RESULTS	Based on multivariate logistic regression model , age over 35 years old ( odds ratio [ OR ] = 7.01 , P = 0.002 ) , human immunodeficiency virus infection ( OR = 40.4 , P < 0.001 ) , diabetes mellitus ( OR = 37.6 , P = 0.001 ) , and placebo treatment ( OR = 0.1 , P = 0.01 ) were identified as predisposing factors for ATDH .
-CONCLUSIONS	Results of our preliminary clinical trial suggested that cotreatment with 2000mg oral L-carnitine solution daily for 4 weeks significantly decreased the rate of ATDH .
-
-###24468797
-OBJECTIVE	Girdles and abdominal binders may reduce pain and stabilize the abdominal wall after laparotomy , but a risk for increased intra-abdominal pressure and decreased lung function is also hypothesized .
-OBJECTIVE	The aim of this study was to investigate the effect of an abdominal girdle after midline laparotomy in a randomized controlled trial .
-METHODS	Twenty-three patients undergoing laparotomy were randomized to wear an elastic girdle postoperatively and 25 were randomized to no girdle .
-METHODS	Pulmonary function was evaluated with ; forced vital capacity ( FVC ) , forced expiratory volume during one second ( FEV1 ) , peak expiratory flow ( PEF ) , and cough PEF .
-METHODS	Pain was recorded using a visual analog scale ( VAS ) .
-METHODS	All patients completed the ventral hernia pain questionnaire ( VHPQ ) before surgery and at the end of the study .
-METHODS	Intra-abdominal pressure was measured via an indwelling urinary catheter .
-METHODS	Wound healing was assessed from photographs .
-RESULTS	FVC , FEV1 , PEF , and cough PEF were reduced by about 30 % after surgery , but there were no differences between patients with or without a girdle ( ANOVA ) .
-RESULTS	Intra-abdominal pressure and wound healing were the same in both groups .
-RESULTS	Pain was significantly lower on day 5 in the girdle group ( p = 0.004 ) .
-CONCLUSIONS	An individually fitted elastic girdle used after midline laparotomy was found to be safe , as this did not affect lung function , coughing , intra-abdominal pressure , or wound healing .
-CONCLUSIONS	The immediate decline in lung function after surgery is restrictive and due to anesthesia and the surgical procedure .
-CONCLUSIONS	Pain was significantly decreased in the girdle group .
-CONCLUSIONS	The study is registered at ClinicalTrials.gov , number NCT01517217 .
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-###24694337
-BACKGROUND	Sexual dimorphism in plasma triglyceride ( TG ) metabolism is well established but it is unclear to what extent it is driven by differences in the sex hormone milieu .
-BACKGROUND	RESULTS from previous studies evaluating the effects of sex steroids on plasma TG homeostasis are inconclusive because they relied on orally administered synthetic hormone preparations or evaluated only plasma lipid concentrations but not kinetics .
-OBJECTIVE	The purpose of this study was to evaluate the effects of systemically delivered 17-estradiol , progesterone , and T on very low density lipoprotein-triglyceride ( VLDL-TG ) concentration and kinetics in postmenopausal women .
-METHODS	VLDL-TG concentration and kinetics were evaluated by using stable isotope-labeled tracer techniques in four groups of postmenopausal women ( n = 27 total ) who were studied before and after treatment with either 17-estradiol ( 0.1 mg/d via continuous delivery skin patch ) , progesterone ( 100 mg/d via vaginal insert ) and T ( 12.5 mg/d via skin gel ) , or no intervention ( control group ) .
-RESULTS	VLDL-TG concentration and kinetics were unchanged in the control group and not altered by T and progesterone administration .
-RESULTS	Estradiol treatment , in contrast , reduced VLDL-TG concentration by approximately 30 % due to accelerated VLDL-TG plasma clearance ( 25.1 2.5 vs. 17.4 2.7 mL/min ; P < .01 ) .
-CONCLUSIONS	Estradiol , but not progesterone or T , is a major regulator of VLDL-TG metabolism .
-
-###25864104
-BACKGROUND	Ombrabulin ( AVE8062 ) disrupts the vasculature of established tumours and has shown preclinical synergistic anti-tumour activity when combined with cisplatin .
-BACKGROUND	In this phase 3 trial , we aimed to assess the efficacy and safety of ombrabulin plus cisplatin compared with placebo plus cisplatin in patients with advanced soft-tissue sarcomas .
-METHODS	We did this multinational , randomised , double-blind , placebo-controlled phase 3 study at 44 centres in ten countries .
-METHODS	Patients aged 18 years and older with metastatic soft-tissue sarcomas , an Eastern Cooperative Oncology Group performance status of 0-2 , and who had previously received treatment with anthracycline and ifosfamide were randomly assigned ( 1:1 ) to intravenous infusion of ombrabulin 25 mg/m ( 2 ) plus cisplatin 75 mg/m ( 2 ) or intravenous infusion of placebo plus cisplatin 75 mg/m ( 2 ) every 3 weeks .
-METHODS	Patients were allocated to treatment using a permuted blocks randomisation scheme ( block size of four ) via an interactive voice-response system , and stratified by histological subtype .
-METHODS	Patients , medical staff , study investigators , and individuals who handled and analysed the data were masked to treatment assignment .
-METHODS	Our primary endpoint was median progression-free survival in the intention-to-treat population .
-METHODS	Safety analyses were done on all randomised patients who received at least one dose of study drug .
-METHODS	This trial is now closed , and is registered with ClinicalTrials.gov , number NCT00699517 .
-RESULTS	Between June 13 , 2008 , and April 26 , 2012 , we randomly assigned 355 patients to ombrabulin plus cisplatin ( n = 176 ) or placebo plus cisplatin ( n = 179 ) .
-RESULTS	Median duration of follow-up was 279 ( IQR 209-332 ) in the placebo group and 305 months ( 207-376 ) in the ombrabulin group .
-RESULTS	Progression-free survival was slightly , but significantly , improved in the ombrabulin group compared with the placebo group ( median 154 months [ 95 % CI 145-269 ] vs 141 [ 138-158 ] months ; hazard ratio 076 [ 95 % CI 059-098 ] ; p = 00302 ) .
-RESULTS	Grade 3 or 4 adverse events occurred more frequently in individuals in the ombrabulin group than in those in the placebo group and included neutropenia ( 34 [ 19 % ] in the ombrabulin group vs 14 [ 8 % ] in the placebo group ) and thrombocytopenia ( 15 [ 8 % ] vs six [ 3 % ] for placebo ) .
-RESULTS	Adverse events leading to death occurred in 18 patients in the ombrabulin group and 10 patients in the placebo group .
-CONCLUSIONS	The combination of ombrabulin and cisplatin significantly improved progression-free survival ; however , it did not show a sufficient clinical benefit in patients with advanced soft-tissue sarcomas to support its use as a therapeutic option .
-CONCLUSIONS	Predictive biomarkers are needed for the rational clinical development of tumour vascular-disrupting drugs for soft-tissue sarcomas .
-BACKGROUND	Sanofi .
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-###24660579
-OBJECTIVE	To compare the curative effects of heat-sensitive moxibustion with conventional drugs on chronic persistent asthma and seek a valuable therapy to replace Western Medicine .
-METHODS	The participants in this multi-center , randomized , and controlled study were randomly divided into two groups : group A ( n = 144 ) , treated with heat-sensitive moxibustion ( 50 sessions ) and group B ( n = 144 ) , treated with Seretide ( salmeterol 50 plg/fluticasone 250 pg , twice a day ) .
-METHODS	The scores of asthma control test ( ACT ) , forced expiratory volume in 1 second ( FEV1 ) , peak expiratory flow ( PEF ) , and attack frequency were measured after 15 , 30 , 60 , and 90 days of treatment .
-METHODS	Patients followed up 3 and 6 months after treatment .
-RESULTS	There was a significant difference ( P = 0.0002 ) in the ACT score and lung function between the two groups after 3 months of treatment and ( P = 0.000 03 ) during the follow-up visits .
-RESULTS	In addition , heat-sensitive moxibustion reduced attack frequency in the period from inclusion to the 6-month follow-up visit .
-CONCLUSIONS	This study shows that heat-sensitive moxibustion may have a comparable curative effect to Seretide ( salmetero/fluticasone ) on asthma .
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-###24295530
-OBJECTIVE	To determine the efficacy of a custom-made wheelchair simulation in training children to use a powered wheelchair ( PWC ) .
-METHODS	Randomized controlled trial employing the 4C/ID-model of learning .
-METHODS	Twenty-eight typically developing children ( 13M , 15F ; mean age 6 years , SD 6 months ) were assessed on their operation of a PWC using a functional evaluation rating scale .
-METHODS	Participants were randomly assigned to intervention ( 8 30-minute training sessions using a joystick operated wheelchair simulation ) or control conditions ( no task ) , and were reassessed on their PWC use after the intervention phase .
-METHODS	Additional data from the simulation on completion times , errors , and total scores were recorded for the intervention group .
-RESULTS	Analysis of variance showed a main effect of time , with planned comparisons revealing a statistically significant change in PWC use for the intervention ( p = .022 ) but not the control condition .
-RESULTS	Although the intervention group showed greater improvement than the controls , this did not reach statistical significance .
-RESULTS	Multiple regression analyses showed that gender was predictive of pretest ( p = .005 ) functional ability .
-CONCLUSIONS	A simulated wheelchair task appears to be effective in helping children learn to operate a PWC .
-CONCLUSIONS	Greater attention should be given to female learners who underperformed when compared with their male counterparts .
-CONCLUSIONS	This low-cost intervention could be easily used at home to reduce PWC training times in children with motor disorders .
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-###24253956
-BACKGROUND	Aim of the study was to compare the chosen position of polyaxial locking screws with the position of monoaxial screws in the humeral head of proximal humeral fractures treated by locked plating .
-METHODS	In a prospective randomized observational study , 124 consecutive patients ( mean age 70.914.8 years ) sustaining a displaced proximal humeral fracture were treated with either monoaxial or polyaxial screw-inserted locking plate fixation .
-METHODS	The chosen positions of locking screws were identified from standardized postoperative radiographs in anteroposterior and outlet-view , with regard to a regional mapping of the humeral head .
-RESULTS	In monoaxial locking technique , a mean of 6 screws purchased the humeral head ( 95 % CI 5.1-6 .2 ) , and in polyaxial locking technique , a mean of 4 screws ( 95 % CI 3.3-4 .5 ) , respectively .
-RESULTS	Screws were placed in the regions superolateral : monoaxial 24.8 % , polyaxial 20.7 % ( p = 0.49 ) ; superomedial : monoaxial 21.9 % , polyaxial 20.0 % ( p = 0.433 ) ; inferolateral : monoaxial 32.5 % , polyaxial 35.0 % ( p = 0.354 ) ; inferomedial : monoaxial 20.8 % , polyaxial 24.2 % ( p = 0.07 ) , superoposterior : monoaxial 45.5 % , polyaxial 30.8 % ( p = 0.57 ) ; superoanterior : monoaxial 4.4 % , polyaxial 8.3 % ( p = 0.33 ) ; inferoposterior : monoaxial 22.5 % , polyaxial 29.8 % ( p = 0.49 ) and inferoanterior : monoaxial 27.5 % , polyaxial : 31.2 % ( p = 0.09 ) .
-CONCLUSIONS	The chosen screws ' position in monoaxial and polyaxial locking plate fixation of displaced proximal humeral fractures do not differ significantly .
-CONCLUSIONS	However , loss of fixation is observed more frequently if the fixation did not include at least one screw within the superoposterior region of the humeral head , suggesting that a screw purchasing the superoposterior region is beneficial in locked plating of proximal humeral fractures .
-METHODS	Treatment Study , Level II .
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-###25122979
-OBJECTIVE	To evaluate the efficacy of a marketed oscillating-rotating ( O-R ) power toothbrush ( Oral-B Triumph with SmartGuide and FlossAction brush head , D34/EB25 ) to a new sonic toothbrush ( Sonicare FlexCare Platinum ) in the reduction of gingivitis and plaque over a 12-week test period .
-METHODS	This was a single center , randomized , open label , examiner-blind , two-treatment , parallel group study .
-METHODS	Subjects who met the entrance criteria were enrolled in the study and randomly assigned to either the O-R or sonic treatment group .
-METHODS	Subjects brushed with their assigned toothbrush and a marketed fluoride dentifrice for two minutes twice daily at home for 12 weeks .
-METHODS	Gingivitis and plaque were evaluated at Baseline , Week 6 , and Week 12 .
-METHODS	Gingivitis was assessed using the Modified Gingival Index ( MGI ) and Gingival Bleeding Index ( GBI ) , and plaque was assessed using the Rustogi Modified Navy Plaque Index ( RMNPI ) .
-METHODS	Data were analyzed using an Analysis of Covariance ( ANCOVA ) with Baseline as the covariate .
-RESULTS	In total , 130 subjects ( 65 per group ) were randomized to treatment and 127 subjects completed the study .
-RESULTS	Both brushes produced statistically significant ( p < 0.001 ) reductions in gingivitis and plaque measures relative to Baseline .
-RESULTS	At Week 12 , the O-R brush demonstrated significantly greater reductions than the sonic brush in whole mouth gingivitis measures ( p = 0.007 ) .
-RESULTS	Additionally , the O-R brush presented significantly fewer bleeding sites ( p < 0.007 ) and significantly greater reductions in whole mouth plaque measures ( p < or = 0.035 ) at Weeks 6 and 12 versus the sonic brush .
-RESULTS	The benefit for the O-R brush versus the sonic brush at Week 12 was 11.7 % for gingivitis , 19.8 % for number of bleeding sites , and 12.2 % for whole mouth plaque .
-RESULTS	There were no adverse events reported or observed for either brush .
-CONCLUSIONS	The oscillating-rotating toothbrush demonstrated statistically significantly greater reductions in whole mouth plaque at Weeks 6 and 12 , as well as significantly greater gingivitis reductions over the long-term ( 12 weeks ) , compared to the new sonic toothbrush .
-
-###24702629
-BACKGROUND	The echocardiographic substudy of the OASIS-6 trial evaluated the prognostic implications of left ventricle ( LV ) systolic and diastolic dysfunction early postacute ST-segment elevation myocardial infarction ( STEMI ) in patients treated with fondaparinux versus usual care .
-METHODS	Comprehensive echocardiograms were performed a median of 6 days after the index STEMI in 528 patients , 258 randomized to fondaparinux and 270 to usual care ( unfractionated heparin or placebo ) , to assess LV systolic and diastolic function , LV mass , and LV end-systolic and end-diastolic volumes .
-METHODS	A total of 245 ( 46.4 % ) patients were followed up for 3 months and 283 ( 53.6 % ) for 6 months .
-METHODS	Major cardiac events ( MACE ) were defined as the composite of death , reinfarction , heart failure , or cardiogenic shock and resuscitated cardiac arrest .
-RESULTS	Patients with LV ejection fraction ( LVEF ) 45 % and restrictive diastolic function ( RDF ) were at greatly increased risk of MACE ( hazard ratio [ HR ] = 8.85 , 95 % CI , 4.2118.60 ) compared to patients with LVEF 45 % and without RDF .
-RESULTS	RDF remained a strong predictor for MACE in patients with LVEF 45 % ( HR = 4.38 , 95 % CI , 1.5212.60 ) and in multivariate models adjusted for LVEF , LV end-systolic volume , and clinical variables .
-CONCLUSIONS	In this large international trial , LV systolic and diastolic function , as determined by echocardiography early following STEMI , are incremental predictors of MACE .
-CONCLUSIONS	In addition , RDF is a strong independent predictor of MACE after STEMI across a broad range of LVEF .
-
-###24906419
-BACKGROUND	The self-reported health and functional status of persons with back pain in the United States have declined in recent years , despite greatly increased medical expenditures due to this problem .
-BACKGROUND	Although patient psychosocial factors such as pain-related beliefs , thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain , few patients receive treatments that address these factors .
-BACKGROUND	Cognitive-behavioral therapy ( CBT ) , which addresses psychosocial factors , has been found to be effective for back pain , but access to qualified therapists is limited .
-BACKGROUND	Another treatment option with potential for addressing psychosocial issues , mindfulness-based stress reduction ( MBSR ) , is increasingly available .
-BACKGROUND	MBSR has been found to be helpful for various mental and physical conditions , but it has not been well-studied for application with chronic back pain patients .
-BACKGROUND	In this trial , we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain , compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes .
-METHODS	In this trial , we will randomize 397 adults with nonspecific chronic back pain to CBT , MBSR or usual care arms ( 99 per group ) .
-METHODS	Both interventions will consist of eight weekly 2-hour group sessions supplemented by home practice .
-METHODS	The MBSR protocol also includes an optional 6-hour retreat .
-METHODS	Interviewers masked to treatment assignments will assess outcomes 5 , 10 , 26 and 52weeks postrandomization .
-METHODS	The primary outcomes will be pain-related functional limitations ( based on the Roland Disability Questionnaire ) and symptom bothersomeness ( rated on a 0 to 10 numerical rating scale ) at 26weeks .
-CONCLUSIONS	If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain , it will become a valuable addition to the limited treatment options available to patients with significant psychosocial contributors to their pain .
-BACKGROUND	Clinicaltrials.gov Identifier : NCT01467843 .
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-###24953208
-BACKGROUND	Endoplasmic reticulum stress and unfolded protein response have been recently associated with the development of inflammatory bowel diseases in adults .
-BACKGROUND	We aimed at assessing the involvement of these pathways also in paediatric inflammatory bowel disease by analysing the expression of the main genes involved in endoplasmic reticulum stress and correlating them with the degree of intestinal inflammation .
-METHODS	Real-time PCR and Western blot analysis of the expression of the endoplasmic reticulum stress marker HSPA5 and of selected genes representing the three pathways of unfolded protein response ( IRE-XBP1 , PERK-ATF4 , ATF6p90-p50 ) in inflamed and uninflamed biopsies from 28 inflammatory bowel disease paediatric patients and 10 controls .
-RESULTS	HSPA5 , PDIA4 , as well as unspliced and spliced XBP1 mRNAs were significantly increased in patients ' inflamed colonic mucosa compared to uninflamed mucosa and controls .
-RESULTS	HSPA5 , PDIA4 , ATF6 , and phospho-IRE proteins were also upregulated , indicating the activation of the IRE-XBP1 and ATF6p90-p50 branches of unfolded protein response .
-RESULTS	A positive significant correlation between interleukin-8 levels , as a marker of inflammation , and upregulated genes was found in the inflamed colonic mucosa .
-CONCLUSIONS	A deregulation of the genes involved in the endoplasmic reticulum stress and unfolded protein response pathways may be a key component of the inflammatory response in paediatric patients with inflammatory bowel disease .
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-###25910800
-BACKGROUND	The aims of the present study were to define the prevalence of untreated atrial fibrillation ( AF ) in a systematic screening program using intermittent ECG recordings among 75 - to 76-year-old individuals and to study the feasibility of initiating protective oral anticoagulant ( OAC ) treatment .
-RESULTS	Half of the 75 - to 76-year-old population in 2 Swedish regions were invited to a screening program for AF .
-RESULTS	Participants without a previous diagnosis of AF underwent intermittent ECG recordings over 2 weeks .
-RESULTS	If AF was detected , participants were offered OAC .
-RESULTS	During the 28-month inclusion period , 13331 inhabitants were invited .
-RESULTS	Of these , 7173 ( 53.8 % ) participated .
-RESULTS	Of the participants , 218 ( 3.0 % ; 95 % confidence interval [ CI ] , 2.7-3 .5 ) were found to have previously unknown AF , and of these , AF was found in 37 ( 0.5 % of the screened population ) on their first ECG .
-RESULTS	The use of intermittent ECGs increased new AF detection 4-fold .
-RESULTS	A previous diagnosis of AF was known in 9.3 % ( n = 666 ; 95 % CI , 8.6-10 .0 ) .
-RESULTS	Total AF prevalence in the screened population was 12.3 % .
-RESULTS	Of participants with known AF , 149 ( 2.1 % ; 95 % CI , 1.8-2 .4 ) had no OAC treatment .
-RESULTS	In total , 5.1 % ( 95 % CI , 4.6-5 .7 ) of the screened population had untreated AF ; screening resulted in initiation of OAC treatment in 3.7 % ( 95 % CI , 3.3-4 .2 ) of the screened population .
-RESULTS	More than 90 % of the participants with previously undiagnosed AF accepted initiation of OAC treatment .
-CONCLUSIONS	Mass screening for AF in a 75 - to 76-year-old population identifies a significant proportion of participants with untreated AF .
-CONCLUSIONS	Initiation of stroke prophylactic treatment was highly successful in individuals with newly diagnosed AF .
-BACKGROUND	URL : http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT01593553 .
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-###25605838
-OBJECTIVE	CEREBEL compared the incidence of CNS metastases as first site of relapse in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer receiving lapatinib-capecitabine or trastuzumab-capecitabine .
-METHODS	Patients without baseline CNS metastases were randomly assigned ( 1:1 ) to receive lapatinib-capecitabine ( lapatinib 1,250 mg per day ; capecitabine 2,000 mg/m ( 2 ) per day on days 1 to 14 every 21 days ) or trastuzumab-capecitabine ( trastuzumab loading dose of 8 mg/kg followed by an infusion of 6 mg/kg every 3 weeks ; capecitabine 2,500 mg/m ( 2 ) per day on days 1 to 14 every 21 days ) .
-METHODS	The primary end point was incidence of CNS metastases as first site of relapse .
-METHODS	Secondary end points included progression-free survival ( PFS ) and overall survival ( OS ) .
-RESULTS	The study was terminated early with 540 enrolled patients ( 271 received lapatinib-capecitabine , and 269 received trastuzumab-capecitabine ) .
-RESULTS	Incidence of CNS metastases as first site of relapse was 3 % ( eight of 251 patients ) for lapatinib-capecitabine and 5 % ( 12 of 250 patients ) for trastuzumab-capecitabine ( treatment differences , -1.6 % ; 95 % CI , -2 % to 5 % ; P = .360 ) .
-RESULTS	PFS and OS were longer with trastuzumab-capecitabine versus lapatinib-capecitabine ( hazard ratio [ HR ] for PFS , 1.30 ; 95 % CI , 1.04 to 1.64 ; HR for OS , 1.34 ; 95 % CI , 0.95 to 1.64 ) .
-RESULTS	Serious adverse events were reported in 13 % ( 34 of 269 patients ) and 17 % ( 45 of 267 patients ) of patients in the lapatinib-capecitabine and trastuzumab-capecitabine arms , respectively .
-CONCLUSIONS	CEREBEL is inconclusive for the primary end point , and no difference was detected between lapatinb-capecitabine and trastuzumab-capecitabine for the incidence of CNS metastases .
-CONCLUSIONS	A better outcome was observed with trastuzumab-capecitabine in the overall population .
-CONCLUSIONS	However , lapatinib-capecitabine efficacy may have been affected by previous exposure to a trastuzumab regimen and/or when treatment was given as first - or second-line therapy in the metastatic setting .
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-###24553304
-OBJECTIVE	Factors underlying differential responsiveness to opioid analgesic medications used in chronic pain management are poorly understood .
-OBJECTIVE	We tested whether individual differences in endogenous opioid inhibition of chronic low-back pain were associated with the magnitude of acute reductions in back pain ratings after morphine administration .
-METHODS	In randomized counterbalanced order over three sessions , 50 chronic low-back pain patients received intravenous naloxone ( 8 mg ) , morphine ( 0.08 mg/kg ) , or placebo .
-METHODS	Back pain intensity was rated predrug and again after peak drug activity was achieved using the McGill Pain Questionnaire-Short Form ( Sensory and Affective subscales , VAS Intensity measure ) .
-METHODS	Opioid blockade effect measures to index degree of endogenous opioid inhibition of back pain intensity were derived as the difference between predrug to postdrug changes in pain intensity across placebo and naloxone conditions , with similar morphine responsiveness measures derived across placebo and morphine conditions .
-RESULTS	Morphine significantly reduced back pain compared with placebo ( McGill Pain Questionnaire-Short Form Sensory , VAS ; P < 0.01 ) .
-RESULTS	There were no overall effects of opioid blockade on back pain intensity .
-RESULTS	However , individual differences in opioid blockade effects were significantly associated with the degree of acute morphine-related reductions in back pain on all measures , even after controlling for effects of age , sex , and chronic pain duration ( P < 0.03 ) .
-RESULTS	Individuals exhibiting greater endogenous opioid inhibition of chronic back pain intensity reported less acute relief of back pain with morphine .
-CONCLUSIONS	Morphine appears to provide better acute relief of chronic back pain in individuals with lower natural opioidergic inhibition of chronic pain intensity .
-CONCLUSIONS	Possible implications for personalized medicine are discussed .
-
-###25615542
-OBJECTIVE	The purpose of this study was to examine a dynamic assessment with graduated prompts to assess morphological awareness and determine whether such a task was related to third-grade literacy success .
-METHODS	A dynamic assessment of morphological awareness was adapted and administered to 54 third-grade students in addition to a norm-referenced language and literacy battery .
-RESULTS	A dynamic assessment of morphological awareness measured a range of performance including that of emerging morphological awareness abilities and provided rich linguistic insights for how best to scaffold and prompt for such a skill .
-RESULTS	In addition , the dynamic morphological awareness measure was found to be significantly related to , and to contribute unique variance to , reading comprehension abilities .
-CONCLUSIONS	These results suggest that morphological awareness is an important factor to consider when addressing students ' literacy performance in early elementary school and that dynamic assessment appears to be a clinically valuable tool when examining early morphological awareness abilities .
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-###24835379
-BACKGROUND	Esophagogastrostomy for oesophageal cancer is the standard surgical treatment .
-BACKGROUND	However , traditional techniques have been associated with high frequency of anastomotic complications .
-BACKGROUND	The purpose of this study is to clarify the superiority of the oesophageal flap valvuloplasty and wrapping suturing technique in preventing postoperative complications after oesophagectomy for oesophageal cancer .
-METHODS	A prospective , randomised study was performed on 394 patients treated for esophageal cancer between January 2006 and December 2010 .
-METHODS	The trial registry number is ChiCTR-TRC-13003817 in the Chinese Clinical Trial Registry .
-RESULTS	Anastomotic leaks occurred in four patients in group A ( 2.1 % ) and in twelve patients in group B ( 6.2 % ) with statistically significant ( P = 0.038 ) .
-RESULTS	During the evaluation of benign stricture seven patients were excluded for hospital mortality .
-RESULTS	Thirty three patients in group A ( 6.9 % ) and 25 patients in group B ( 13.2 % ) occurred anastomotic stricture respectively ( P = 0.044 ) .
-RESULTS	Furthermore , reflux oesophagitis and Barrett 's epithelium were found in 105 patients ( 55.3 % ) of group B , and 54 ( 28.7 % ) patients in group A ( P < 0.001 ) .
-CONCLUSIONS	The oesophageal flap valvuloplasty and wrapping suturing technique decreased anastomotic leakage incidence and stricture rate thereby decreasing the morbidity and mortality .
-CONCLUSIONS	This procedure also prevented the occurrence of gastroesophageal reflux after esophagectomy .
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-###24789659
-OBJECTIVE	Ultrasound-guided long-axis in-plane sciatic perineural catheter insertion has been described but not validated .
-OBJECTIVE	For the popliteal-sciatic nerve , we hypothesized that a long-axis in-plane technique , placing the catheter parallel and posterior to the nerve , results in faster onset of sensory anesthesia compared to a short-axis in-plane technique .
-METHODS	Preoperatively , patients receiving a popliteal-sciatic perineural catheter were randomly assigned to either the long-axis or short-axis technique .
-METHODS	Mepivacaine 2 % was administered via the catheter following insertion .
-METHODS	The primary outcome was time to achieve complete sensory anesthesia .
-METHODS	Secondary outcomes included procedural time , onset time of motor block , and pain on postoperative day 1 .
-RESULTS	Fifty patients were enrolled .
-RESULTS	In the long-axis group ( n = 25 ) , all patients except 1 ( 4 % ) had successful catheter placement per protocol .
-RESULTS	Two patients ( 8 % ) in the long-axis group and 1 patient ( 4 % ) in the short-axis group ( n = 25 ) did not achieve sensory anesthesia by 30 min and were withdrawn .
-RESULTS	Seventeen of 24 ( 71 % ) and 17 of 22 ( 77 % ) patients in the short-axis and long-axis groups , respectively , achieved the primary outcome of complete sensory anesthesia ( p = 0.589 ) .
-RESULTS	The short-axis group ( n = 17 ) required a median ( 10th-90th ) of 18.0 ( 8.4-30 .0 ) min compared to 18.0 ( 11.4-27 .6 ) min for the long-axis group ( n = 17 , p = 0.208 ) to achieve complete sensory anesthesia .
-RESULTS	Procedural time was 6.5 ( 4.0-12 .0 ) min for the short-axis and 9.5 ( 7.0-12 .7 ) min for the long-axis ( p < 0.001 ) group .
-RESULTS	There were no statistically significant differences in other secondary outcomes .
-CONCLUSIONS	Long-axis in-plane popliteal-sciatic perineural catheter insertion requires more time to perform compared to a short-axis in-plane technique without demonstrating any advantages .
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-###25288340
-OBJECTIVE	Although the analgesic effect of periarticular injection after total knee arthroplasty ( TKA ) has been well documented , the gold standard for drug combination has not yet been established .
-OBJECTIVE	In this study , the analgesic effects of six different drug combinations were compared .
-METHODS	A total of 256 patients undergoing TKA for primary osteoarthritis were randomized into one of six groups : a control group ( saline solution , epinephrine , and cefazolin , n = 42 ) , Group 1 ( ropivacaine , n = 43 ) , Group 2 ( ropivacaine + morphine , n = 43 ) , Group 3 ( ropivacaine + ketorolac , n = 42 ) , Group 4 ( ropivacaine + morphine + ketorolac , n = 43 ) , and Group 5 ( ropivacaine + morphine + ketorolac + methylprednisolone , n = 43 ) .
-METHODS	Pain level assessed by visual analogue scale ( VAS ) and opioid consumption were primary outcomes .
-METHODS	The incidence of complications , range of motion ( ROM ) , C-reactive protein ( CRP ) value , and the amount of post-operative blood drainage were also compared .
-RESULTS	Patients in Groups 4 and 5 complained less pain than the control group for the first 12 h after surgery , and the patients in the other groups showed less pain only during the initial 6 h after surgery .
-RESULTS	Groups 4 and 5 also showed less opioid consumption than the control group during the 24 h period after surgery .
-RESULTS	Patients in Group 5 showed no significant difference in VAS score and opioid consumption compared with Group 4 , but they had lower CRP value and greater ROM than any other groups at post-operative day 2 and day 4 .
-CONCLUSIONS	The combination of ropivacaine , morphine , and ketorolac showed a significantly stronger and sufficiently synergistic analgesic effect without adding methylprednisolone in periarticular injection after TKA .
-CONCLUSIONS	The clinical relevance of the study is that the combination of ropivacaine , morphine , and ketorolac can be a good option for periarticular injection following TKA in terms of synergistic analgesic effect and efficiency of drug combination .
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-###25982539
-BACKGROUND	Secukinumab has demonstrated high , sustained efficacy in psoriasis to 52 weeks on a fixed-interval regimen .
-OBJECTIVE	We sought to compare a retreatment-as-needed versus a fixed-interval regimen .
-METHODS	In this double-blind study , adults with moderate to severe plaque psoriasis were randomized 1:1 to subcutaneous secukinumab at 300 mg ( n = 484 ) or 150 mg ( n = 482 ) weekly from baseline until week 4 , and at week 8 .
-METHODS	At week 12 , patients achieving 75 % or more improvement from baseline Psoriasis Area and Severity Index score ( PASI 75 ) were rerandomized to 2 dose levels of secukinumab retreatment as needed ( n = 217 , 300 mg ; n = 206 , 150 mg ) or fixed interval ( n = 217 ; n = 203 ) .
-METHODS	Primary end point was noninferiority of retreatment as needed versus fixed interval for maintaining PASI 75 to week 52 .
-RESULTS	Secukinumab induced high responses by week 12 ( 84.4 % -91.1 % PASI 75 responders ) .
-RESULTS	From week 12 to week 52 , more patients on fixed interval ( 78.2 % , 300 mg ; 62.1 % , 150 mg ) maintained PASI 75 versus retreatment as needed ( 67.7 % ; 52.4 % ) ; statistical noninferiority of retreatment as needed was not established .
-RESULTS	Overall safety , including very low incidences of treatment-emergent anti-drug antibodies ( < 0.5 % ) , was similar between regimens .
-CONCLUSIONS	The primary end point was developed without any known precedent .
-CONCLUSIONS	Secukinumab fixed interval showed clear benefit versus the study-specified retreatment-as-needed regimen for maintaining efficacy .
-CONCLUSIONS	Both regimens exhibited safety consistent with previous trials .
-CONCLUSIONS	The potential of retreatment as needed with secukinumab warrants further investigation .
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-###25847605
-OBJECTIVE	The purpose of this study was to quantify the frequency and clinical severity of quality deficiencies in intensity modulated radiation therapy ( IMRT ) planning in the Radiation Therapy Oncology Group 0126 protocol .
-METHODS	A total of 219 IMRT patients from the high-dose arm ( 79.2 Gy ) of RTOG 0126 were analyzed .
-METHODS	To quantify plan quality , we used established knowledge-based methods for patient-specific dose-volume histogram ( DVH ) prediction of organs at risk and a Lyman-Kutcher-Burman ( LKB ) model for grade 2 rectal complications to convert DVHs into normal tissue complication probabilities ( NTCPs ) .
-METHODS	The LKB model was validated by fitting dose-response parameters relative to observed toxicities .
-METHODS	The 90th percentile ( 22 of 219 ) of plans with the lowest excess risk ( difference between clinical and model-predicted NTCP ) were used to create a model for the presumed best practices in the protocol ( pDVH0126 , top10 % ) .
-METHODS	Applying the resultant model to the entire sample enabled comparisons between DVHs that patients could have received to DVHs they actually received .
-METHODS	Excess risk quantified the clinical impact of suboptimal planning .
-METHODS	Accuracy of pDVH predictions was validated by replanning 30 of 219 patients ( 13.7 % ) , including equal numbers of presumed `` high-quality , '' `` low-quality , '' and randomly sampled plans .
-METHODS	NTCP-predicted toxicities were compared to adverse events on protocol .
-RESULTS	Existing models showed that bladder-sparing variations were less prevalent than rectum quality variations and that increased rectal sparing was not correlated with target metrics ( dose received by 98 % and 2 % of the PTV , respectively ) .
-RESULTS	Observed toxicities were consistent with current LKB parameters .
-RESULTS	Converting DVH and pDVH0126 , top10 % to rectal NTCPs , we observed 94 of 219 patients ( 42.9 % ) with 5 % excess risk , 20 of 219 patients ( 9.1 % ) with 10 % excess risk , and 2 of 219 patients ( 0.9 % ) with 15 % excess risk .
-RESULTS	Replanning demonstrated the predicted NTCP reductions while maintaining the volume of the PTV receiving prescription dose .
-RESULTS	An equivalent sample of high-quality plans showed fewer toxicities than low-quality plans , 6 of 73 versus 10 of 73 respectively , although these differences were not significant ( P = .21 ) due to insufficient statistical power in this retrospective study .
-CONCLUSIONS	Plan quality deficiencies in RTOG 0126 exposed patients to substantial excess risk for rectal complications .
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-###25475461
-BACKGROUND	Transfer patterns , procedure rates , and outcomes of patients with non-ST-segment elevation myocardial infarction ( NSTEMI ) presenting to Canadian community hospitals are not well understood .
-METHODS	We documented all patients admitted to British Columbia ( BC ) hospitals with a primary diagnosis of NSTEMI between 2007 and 2008 .
-METHODS	Patients were divided by admitting hospital type into tertiary care hospitals , nonremote community hospitals , and remote community hospitals .
-METHODS	The aims were to compare transfer rates and time to transfer to a tertiary hospital as well as procedure rates and outcomes at index admission , at 30 days , and at 1 year .
-RESULTS	The mean transfer rates to a tertiary hospital were 72.6 % for nonremote and 57.1 % for remote community hospitals ( P < 0.001 ) .
-RESULTS	Times to and rates of cardiac procedures differed significantly among these 3 hospital types .
-RESULTS	Admission to a nonremote or remote community hospital was associated with similar 1-year mortality compared with admission to a tertiary care hospital ( nonremote hospitals , adjusted odds ratio [ OR ] , 0.87 ; P = 0.26 ; remote hospitals , adjusted OR , 1.19 ; P = 0.33 ) .
-RESULTS	At 1 year , admission to a nonremote community hospital was associated with a lower composite outcome of death or readmission for acute myocardial infarction ( AMI ) ( adjusted OR , 0.80 ; P = 0.04 ) .
-CONCLUSIONS	One-year mortality rates were not different between patients with NSTEMI admitted to BC community and tertiary care hospitals ; however , the rate of readmission for AMI/death was significantly less in patients admitted to nonremote community hospitals .
-CONCLUSIONS	This should prompt the evaluation of key outcomes in NSTEMI in other community hospital settings .
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-###24636956
-BACKGROUND	There is limited evidence supporting the podiatric treatment of children with juvenile idiopathic arthritis ( JIA ) .
-BACKGROUND	This multicentre randomised controlled trial aimed to determine whether preformed foot orthoses ( FOs ) impacted on pain and quality of life ( QoL ) in children with JIA .
-METHODS	Eligible children were randomised to receive either ` fitted ' FOs with customised chair-side corrections or ` control ' FOs made without corrections .
-METHODS	Changes in pain and QoL were measured using a visual analogue scale and Paediatric Quality of Life questionnaire , respectively .
-METHODS	JIA children were assessed at baseline , 3 months and 6 months .
-RESULTS	60 children were recruited .
-RESULTS	179 out of a possible 180 assessments ( 99.4 % ) were completed .
-RESULTS	A statistically significant greater difference in pain reduction ( baseline - 6 months ) was seen between the two groups favouring fitted FOs ( p = 0.029 ) .
-RESULTS	The reduction in pain in the fitted FOs group was clinically important ( 8 mm ) .
-RESULTS	Significant differences in QoL favouring fitted FOs were also identified as measured by the children and independently by their parents/carers .
-CONCLUSIONS	Fitted FOs may reduce pain and improve QoL in selected children with JIA .
-BACKGROUND	NCT02001844 .
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-###25288125
-BACKGROUND	Edgewise fixed orthodontic appliances are available in two different bracket slot sizes ( 0.018 and 0.022 inch ) .
-BACKGROUND	Both systems are used by clinicians worldwide with some orthodontists claiming the superiority and clinical advantages of one system over the other .
-BACKGROUND	However , the scientific evidence supporting this area is scarce and weak .
-BACKGROUND	This leaves the clinician 's choice of bracket slot system to clinical preference .
-BACKGROUND	We aim to compare the 0.018-inch and 0.022-inch pre-adjusted bracket slot systems in terms of the effectiveness of orthodontic treatment .
-METHODS	This is a prospective , multicenter , randomized clinical trial , undertaken in the secondary care hospital environment in the NHS Tayside region of Scotland ( United Kingdom ) .
-METHODS	A total of 216 orthodontic patients will be recruited in three centers in secondary care hospitals in NHS Tayside .
-METHODS	The participants will be randomly allocated to treatment with either the 0.018-inch or 0.022-inch bracket slot systems ( n = 108 for each group ) using Victory series conventional pre-adjusted bracket systems ( 3 M Unitek , Monrovia , United States ) .
-METHODS	Baseline records and outcome data collected during and at the end of orthodontic treatment will be assessed .
-METHODS	The primary outcome measures will be the duration of orthodontic treatment in the maxillary and mandibular arches .
-METHODS	The secondary outcome measures will be the number of scheduled appointments for orthodontic treatment in the maxillary and mandibular arches , treatment outcome using Peer Assessment Rating index ( PAR ) , orthodontically induced inflammatory root resorption ( as measured using periapical radiographs ) and the patient 's perception of wearing orthodontic appliances .
-CONCLUSIONS	The results from the current study will serve as evidence to guide the clinician in deciding whether the difference in bracket slot size has a significant impact on the effectiveness of orthodontic treatment .
-BACKGROUND	Registered with ClinicalTrials.gov on 5 March 2014 , registration number : NCT02080338 .
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-###25141203
-OBJECTIVE	Compare the effectiveness of Papacarie gel for the chemo-mechanical removal of carious lesions on primary teeth to conventional caries removal with a low-speed bur with regard to execution time , clinical aspects and radiographic findings .
-METHODS	A randomized controlled clinical trial with a split-mouth design was carried out .
-METHODS	The sample was composed of 20 children aged four to seven years , in whom 40 deciduous teeth were randomly divided into two groups : chemo-mechanical caries removal with Papacarie and removal of carious dentin with a low-speed bur .
-METHODS	Each child underwent both procedures and served as his/her own control .
-METHODS	Restorations were performed with glass ionomer cement .
-METHODS	The time required to perform the procedure was also analyzed .
-METHODS	The patients underwent longitudinal clinical and radiographic follow-up of the restorations .
-RESULTS	No statistically significant difference between groups was found regarding the time required to perform the procedures and the radiographic follow up .
-RESULTS	Statistically significant differences between groups were found in the clinical evaluation at 6 and 18 months after treatment .
-CONCLUSIONS	Papacarie is as effective as the traditional method for the removal of carious dentin on deciduous teeth , but offers the advantages of the preservation of sound dental tissue as well as the avoidance of sharp rotary instruments and local anesthesia .
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-###25551626
-OBJECTIVE	To examine whether hippotherapy has a clinically significant effect on gross motor function in children with cerebral palsy ( CP ) .
-METHODS	Randomized controlled trial .
-METHODS	Outpatient therapy center .
-METHODS	Ninety-two children with CP , aged 4-10 years , presenting variable function ( Gross Motor Function Classification System [ GMFCS ] levels I-IV ) .
-METHODS	Hippotherapy ( 30 minutes twice weekly for 8 consecutive weeks ) .
-METHODS	Gross Motor Function Measure ( GMFM ) -88 , GMFM-66 , and Pediatric Balance Scale .
-RESULTS	Pre - and post-treatment measures were completed by 91 children ( 45 in the intervention group and 46 in the control group ) .
-RESULTS	Differences in improvement on all three measures significantly differed between groups after the 8-week study period .
-RESULTS	Dimensions of GMFM-88 improved significantly after hippotherapy varied by GMFCS level : dimension E in level I , dimensions D and E in level II , dimensions C and D in level III , and dimensions B and C in level IV .
-CONCLUSIONS	Hippotherapy positively affects gross motor function and balance in children with CP of various functional levels .
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-###25249320
-BACKGROUND	Treatment options for plantar fasciitis have resulted in varied patient outcomes .
-BACKGROUND	The aim of this study was to compare a novel treatment , cryopreserved human amniotic membrane ( c-hAM ) , to a traditional treatment , corticosteroid .
-BACKGROUND	Our hypothesis was that c-hAM would be safe and comparable to corticosteroids for plantar fasciitis in regard to patient outcomes .
-METHODS	A randomized , controlled , double-blind , single-center pilot study was completed .
-METHODS	Patients were randomized into one of 2 treatment groups : c-hAM or corticosteroid .
-METHODS	Patients received an injection at their initial baseline visit with an option for a second injection at their first 6-week follow-up .
-METHODS	Total follow-up was obtained for 12 weeks after the most recent injection .
-METHODS	The primary outcome measurement was the Foot Health Status Questionnaire ( FHSQ ) .
-METHODS	The secondary outcome measurements were the Visual Analog Scale ( VAS ) and verbally reported percentage improvement .
-METHODS	Data were analyzed between groups for the 2 different cohorts ( 1 injection versus 2 injections ) .
-METHODS	Twenty-three patients had complete follow-up .
-METHODS	Fourteen were randomized to receive corticosteroid and 9 were randomized to receive c-hAM .
-RESULTS	Three patients in each group received second injections .
-RESULTS	With the numbers available , the majority of outcome measurements showed no statistical difference between groups .
-RESULTS	The corticosteroid did , however , have greater FHSQ shoe fit improvement ( P = .0244 ) at 6 weeks , FHSQ general health improvement ( P = .0132 ) at 6 weeks , and verbally reported improvement ( P = .041 ) at 12 weeks in the one-injection cohort .
-RESULTS	Cryopreserved hAM had greater FHSQ foot pain improvement ( P = .0113 ) at 18 weeks in the 2-injection cohort .
-CONCLUSIONS	Cryopreserved hAM injection may be safe and comparable to corticosteroid injection for treatment of plantar fasciitis .
-CONCLUSIONS	This is a pilot study and requires further investigation .
-METHODS	Level I , prospective randomized trial .
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-###24732230
-BACKGROUND	Placing a central venous access device via the internal jugular or subclavian vein entails significant risks to both patient and healthcare worker .
-OBJECTIVE	The purpose of this randomized , prospective study was to determine whether the accelerated Seldinger technique ( AST ) offers significant safety advantages over the modified Seldinger technique ( MST ) for peripherally inserted central catheter insertion .
-METHODS	Patients were randomly assigned to undergo introducer sheath insertion by means of either MST or AST .
-METHODS	Primary outcome measures included time to completion of introducer sheath insertion , estimated blood loss , and success rate .
-METHODS	Secondary outcome measures included vessel-to-air exposure events and unprotected sharps exposure .
-CONCLUSIONS	While both insertion methods proved equivalent for successful vessel cannulation , AST was significantly faster ( P = 0.0048 ) and resulted in less blood loss ( P = 0.0295 ) than MST .
-CONCLUSIONS	Additionally , AST resulted in significantly fewer vessel-to-air exposure events ( P < 0.0001 ) and unprotected sharps exposures ( P < 0.0001 ) .
-CONCLUSIONS	Although this was a relatively small and unblinded study , the high degree of statistical significance of the study results suggests that , for both patients and healthcare workers , AST is faster and safer than MST for PICC peelable introducer sheath insertion .
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-###25504811
-OBJECTIVE	A significant proportion of patients with rheumatoid arthritis do not respond adequately to biologic treatment .
-OBJECTIVE	We hypothesized that lack of response to ( biologic ) disease-modifying antirheumatic drugs ( DMARDs ) is high in patients in whom the subjective , patient-reported component of the Disease Activity Score 28 ( DAS28 ) is high at baseline .
-OBJECTIVE	The primary aim of our present study was to investigate the contribution of the more subjective versus the objective components of the DAS28 to response to biologic agents in RA patients , as well as the changes in this contribution over time .
-OBJECTIVE	The secondary aim was to examine whether the value of this subjective contribution at baseline affects the response to treatment .
-METHODS	The DAS28-P ( the subjective components of the DAS28 relative to the total DAS28 ) was calculated .
-METHODS	Patients were derived from the computer-assisted Management in Early Rheumatoid Arthritis Trial-II and the Biologicals and Outcome Compared and Predicted in Utrecht Region in Rheumatoid Arthritis Study .
-METHODS	Ordinal logistic regression analyses were performed .
-RESULTS	The DAS28-P score at baseline was not associated with the level of response according to European League Against Rheumatism criteria at 3 months .
-RESULTS	Overall , a significant reduction in the DAS28-P score was observed 3 months after start of treatment , showing a greater reduction of the combined subjective components in good responders .
-CONCLUSIONS	The results reject the hypothesis that the lack of response to biologic DMARDs is especially high in patients in whom the patient-reported component of the DAS28 is high at baseline ; these subjective components are not linked to treatment response .
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-###25275368
-BACKGROUND	Coordination between breathing and swallowing helps prevent aspiration of foreign material into the respiratory tract .
-BACKGROUND	The authors examined the effects of anesthesia and hypercapnia on swallowing-breathing coordination .
-METHODS	In a randomized controlled crossover study , general anesthesia with propofol or sevoflurane was titrated using an up-down method to identify the threshold for suppression of the motor response to electrical stimulation of the forearm .
-METHODS	Additional measurements included bispectral index , genioglossus electromyogram , ventilation ( pneumotachometer ) , and hypopharyngeal pressure .
-METHODS	During wakefulness and at each level of anesthesia , carbon dioxide was added to increase the end-tidal pressure by 4 and 8 mmHg .
-METHODS	A swallow was defined as increased genioglossus activity with deglutition apnea and an increase in hypopharyngeal pressure .
-METHODS	Spontaneous swallows were categorized as physiological ( during expiration or followed by expiration ) or pathological ( during inspiration or followed by an inspiration ) .
-RESULTS	A total of 224 swallows were analyzed .
-RESULTS	Anesthesia increased the proportion of pathological swallows ( 25.9 % vs. 4.9 % ) and decreased the number of swallows per hour ( 1.73.3 vs. 28.022.3 ) compared to wakefulness .
-RESULTS	During anesthesia , hypercapnia decreased hypopharyngeal pressure during inspiration ( -14.13.7 vs. -8.72 mmHg ) and increased minute ventilation , the proportion of pathological swallows ( 19.1 % vs. 12.3 % ) , and the number of swallows per hour ( 5.517.0 .
-RESULTS	vs. 1.35.5 ) .
-CONCLUSIONS	Anesthesia impaired the coordination between swallowing and respiration .
-CONCLUSIONS	Mild hypercapnia increased the frequency of swallowing during anesthesia and the likelihood of pathological swallowing .
-CONCLUSIONS	During anesthesia , the risk for aspiration may be further increased when ventilatory drive is stimulated .
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-###25256013
-BACKGROUND	In ruminants , lower ruminal pH causes massive disruption of ruminal epithelial structure during periods of feeding high-concentrate diets .
-BACKGROUND	However , the influence of excessive organic fatty acids in the lumen of hindgut on the epithelial structure is unclear .
-BACKGROUND	In this study , twelve mid-lactating goats were randomly assigned to either a HC diet group ( 65 % concentrate of dry matter ; n = 6 ) or a LC diet group ( 35 % concentrate of dry matter ; n = 6 ) for 10 weeks .
-BACKGROUND	The colonic epithelial structure was detected by HE staining and transmission electron microscopy ( TEM ) , and the apoptotic status of epithelial cells was estimated by TUNEL method and caspase activities .
-RESULTS	HC goats showed higher level of free lipopolysaccharide ( LPS ) in rumen fluid ( p < 0.01 ) but not in colonic digesta ( p > 0.05 ) , and higher total volatile fatty acid ( VFA ) concentrations in rumen fluid ( p < 0.05 ) and in colonic digesta ( p < 0.01 ) , and higher content of starch in colonic digesta ( p < 0.05 ) compared to LC goats .
-RESULTS	HC goats demonstrated profound alterations in the colonic epithelial structure and tight junctions ( TJ ) , apparently due to damage of the epithelium with widened TJs space and nuclear breakdown and mitochondrial swelling .
-RESULTS	HC goats showed higher level of apoptosis in the colonic epithelium with higher proportion of TUNEL-positive apoptotic cells and increases of caspase-3 and -3 / 7 activities , as well as the lower ratio of bcl-2 / bax mRNA expression in the colonic mucosa ( p < 0.05 ) .
-RESULTS	However , - defense mRNA was significantly down-regulated in the colonic mucosa of HC goats compared to LC ( p < 0.05 ) .
-RESULTS	HC goats showed higher level of TJ proteins including claudin-1 and claudin-4 in the colonic mucosa than LC ( p < 0.05 ) .
-RESULTS	Neither free LPS content in the colonic digesta nor NF - B protein expression in tissues showed significant difference between HC and LC goats ( p > 0.05 ) .
-CONCLUSIONS	Our results reveal that long-term feeding HC diet to lactating goats causes severe damages to the colonic mucosa barrier associated with activating cells apoptosis .
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-###24625322
-BACKGROUND	Earlier kinetics of serum HCV core antigen ( HCVcAg ) and its predictive value on sustained virological response ( SVR ) were investigated in patients with genotype 1 HCV infection during antiviral treatment .
-METHODS	In a multi-centered , randomized and positive drug-controlled phase IIb clinical trial on type Y peginterferon -2 b ( NCT01140997 ) , forty-eight CHC patients who participated in pharmacokinetics were randomly divided into 4 cohorts and treated with PegIFN ( type Y peginterferon -2 b 90 g , 135 g , 180 g and PegIFN-2a 180 g , respectively , once a week ) and ribavirin ( < 75 kg , 1000 mg daily and75 kg , 1200 mg daily ) for 48 weeks , and then followed up for 24 weeks .
-METHODS	32 patients infected with genotype 1 HCV and completed the whole process were included in this study .
-METHODS	HCV RNAs were detected at baseline , and weeks 4 , 12 , 24 , 48 and 72 using Cobas TaqMan .
-METHODS	ARCHITECT HCVcAg was performed at 24 , 48 , 72 , 96 , 120 and 144 h in addition to the above time points .
-METHODS	The receiver operating curves ( ROCs ) were performed to study the predictive values of HCVcAg decline on SVR .
-RESULTS	Following antiviral treatment , serum HCVcAg levels rapidly declined within the first week and correlated well with corresponding HCV RNA at baseline , weeks 4 , 12 , 24 , 48 and 72 ( rs = 0.969 , 0.928 , 0.999 , 0.983 , 0.985 and 0.946 , respectively , P < 0.001 ) .
-RESULTS	All of the areas under the receiver operating curves ( AUROCs ) were more than 0.80 and showed good predictive power on SVR at 24 , 48 , 72 , 96 , 120 and 144 h. The144 h was the best predictive time point of HCVcAg decline on SVR because of its largest AUROC ( more than 0.90 ) .
-CONCLUSIONS	Early kinetics of serum HCVcAg predicts SVR very well in genotype 1 CHC patients during antiviral treatment , and its reduction value at 144 h is an earlier and stronger predictor on SVR than rapid virological response and early virological response .
-CONCLUSIONS	( TRN : NCT01140997 ) .
-
-###25376971
-BACKGROUND	The pectoral nerves ( Pecs ) block types I and II are novel techniques to block the pectoral , intercostobrachial , third to sixth intercostals , and the long thoracic nerves .
-BACKGROUND	They may provide good analgesia during and after breast surgery .
-BACKGROUND	Our study aimed to compare prospectively the quality of analgesia after modified radical mastectomy surgery using general anesthesia and Pecs blocks versus general anesthesia alone .
-METHODS	One hundred twenty adult female patients scheduled for elective unilateral modified radical mastectomy under general anesthesia were randomly allocated to receive either general anesthesia plus Pecs block ( Pecs group , n = 60 ) or general anesthesia alone ( control group , n = 60 ) .
-RESULTS	Statistically significant lower visual analog scale pain scores were observed in the Pecs group than in the control group patients .
-RESULTS	Moreover , postoperative morphine consumption in the Pecs group was lower in the first 12 hours after surgery than in the control group .
-RESULTS	In addition , statistically significant lower intraoperative fentanyl consumption was observed in the Pecs group than in the control group .
-RESULTS	In the postanesthesia care unit , nausea and vomiting as well as sedation scores were lower in the Pecs group compared with the control group .
-RESULTS	Overall , postanesthesia care unit and hospital stays were shorter in the Pecs group than in the control group .
-CONCLUSIONS	The combined Pecs I and II block is a simple , easy-to-learn technique that produces good analgesia for radical breast surgery .
-
-###26223721
-OBJECTIVE	To investigate the effects of different types of nasal packings on middle ear pressure in patients undergoing septoplasty .
-METHODS	Sixty patients who were suffering from nasal obstruction and who had to undergo septoplasty because of nasal septal deviation were included in the study .
-METHODS	After the septoplasty , Merocel packings and internal nasal splints were intraoperatively applied in thirty patients each .
-METHODS	Middle ear pressure was evaluated by tympanometry .
-METHODS	Tympanometric peak pressures were used for this aim .
-METHODS	Acoustic impedance measurements were performed in both ears , and the average values of the two ears were calculated .
-METHODS	Tympanometric measurements were performed for patients during the preoperative period and on the 2 ( nd ) and 5 ( th ) postoperative days .
-RESULTS	There were 30 ( 5 females , 25 males ; average age 23 years ) patients in the internal nasal splint group and 30 ( 8 females , 22 males ; average age 26 years ) patients in the anterior Merocel packing group .
-RESULTS	When the values obtained by acoustic impedancemetry before the operation and on the postoperative 5 ( th ) day were compared , there was no statistically significant difference between the groups .
-RESULTS	The middle ear pressure significantly decreased in the anterior Merocel packing group compared with that in the internal nasal splint group .
-RESULTS	The intragroup comparison of the acoustic impedance measurements of the internal nasal splint group revealed no significant difference between the preoperative acoustic impedance values and the values obtained on the postoperative 2 ( nd ) day .
-CONCLUSIONS	Cannulated silicone intranasal splints are better in terms of patient comfort after an intranasal surgery without effecting eustachian tube function .
-
-###25171216
-BACKGROUND	Cerebral palsy refers to permanent , mutable motor development disorders stemming from a primary brain lesion , causing secondary musculoskeletal problems and limitations in activities of daily living .
-BACKGROUND	The aim of the present study was to determine the effects of gait training combined with transcranial direct-current stimulation over the primary motor cortex on balance and functional performance in children with cerebral palsy .
-METHODS	A double-blind randomized controlled study was carried out with 24 children aged five to 12 years with cerebral palsy randomly allocated to two intervention groups ( blocks of six and stratified based on GMFCS level ( levels I-II or level III ) .
-METHODS	The experimental group ( 12 children ) was submitted to treadmill training and anodal stimulation of the primary motor cortex .
-METHODS	The control group ( 12 children ) was submitted to treadmill training and placebo transcranial direct-current stimulation .
-METHODS	Training was performed in five weekly sessions for 2 weeks .
-METHODS	Evaluations consisted of stabilometric analysis as well as the administration of the Pediatric Balance Scale and Pediatric Evaluation of Disability Inventory one week before the intervention , one week after the completion of the intervention and one month after the completion of the intervention .
-METHODS	All patients and two examiners were blinded to the allocation of the children to the different groups .
-RESULTS	The experimental group exhibited better results in comparison to the control group with regard to anteroposterior sway ( eyes open and closed ; p < 0.05 ) , mediolateral sway ( eyes closed ; p < 0.05 ) and the Pediatric Balance Scale both one week and one month after the completion of the protocol .
-CONCLUSIONS	Gait training on a treadmill combined with anodal stimulation of the primary motor cortex led to improvements in static balance and functional performance in children with cerebral palsy .
-BACKGROUND	Ensaiosclinicos.gov.br / RBR-9B5DH7 .
-
-###24875890
-OBJECTIVE	To determine the effects of dexmedetomidine premedication on the minimum alveolar concentration of sevoflurane for tracheal intubation ( MACTI ) in children .
-METHODS	Prospective , randomized , clinical comparison study .
-METHODS	Operating room of an academic hospital .
-METHODS	90 pediatric , ASA physical status 1 patients , aged 3 to 7 years , scheduled for minor elective surgery .
-METHODS	Patients were randomized to three groups to receive placebo , dexmedetomidine 1 g/kg , or dexmedetomidine 2 g/kg approximately 60 minutes before anesthesia .
-METHODS	Anesthesia was induced with sevoflurane .
-METHODS	Each concentration of sevoflurane for which a tracheal intubation was attempted was predetermined according to modification of the Dixon 's up-and-down method , with 0.25 % as a step size and held constant for at least 15 minutes before tracheal intubation .
-METHODS	All responses ( `` movement '' or `` no movement '' ) to tracheal intubation were assessed .
-RESULTS	The MACTI of sevoflurane was 2.82 % 0.17 % in the control group , 2.26 % 0.18 % in the 1 g/kg dexmedetomidine group , and 1.83 % 0.16 % in the 2 g/kg dexmedetomidine group .
-RESULTS	Dexmedetomidine premedication ( 1 and 2 g/kg ) decreased the MACTI of sevoflurane by 20 % and 35 % , respectively .
-RESULTS	There were no clinically significant episodes of hypotension or bradycardia in any patients .
-CONCLUSIONS	Intranasal dexmedetomidine premedication produces a dose-dependent decrease in the concentration of sevoflurane needed for tracheal intubation in children .
-
-###25611944
-OBJECTIVE	To examine the effect of weight loss on sleep duration , sleep quality , and mood in 390 obese men and women who received one of three behavioral weight loss interventions in the Practice-based Opportunities for Weight Reduction trial at the University of Pennsylvania ( POWER-UP ) .
-METHODS	Sleep duration and quality were assessed at baseline and months 6 and 24 by the Pittsburgh Sleep Quality Index ( PSQI ) questionnaire and mood by the Patient Health Questionnaire-8 ( PHQ-8 ) .
-METHODS	Changes in sleep and mood were examined according to treatment group and based on participants ' having lost 5 % of initial weight vs. < 5 % .
-RESULTS	There were few significant differences between treatment groups in changes in sleep or mood .
-RESULTS	At month 6 , however , mean ( SD ) min of sleep increased significantly more in participants who lost 5 % vs. < 5 % ( 21.67.2 vs. 1.26.0 min , P = 0.0031 ) .
-RESULTS	PSQI total scores similarly improved ( declined ) more in those who lost 5 % vs. < 5 % ( -1.20.2 vs. -0.40.2 , P < 0.001 ) , as did PHQ-8 scores ( -2.50.4 vs. -0.10.3 , P < 0.0001 ) .
-RESULTS	At month 24 , only the differences in mood remained statistically significant ( P < 0.05 ) .
-CONCLUSIONS	Losing 5 % of initial weight was associated with short-term improvements in sleep duration and sleep quality , as well as favorable short - and long-term changes in mood .
-
-###25219423
-OBJECTIVE	The STRIDE study assessed whether a lifestyle intervention , tailored for individuals with serious mental illnesses , reduced weight and diabetes risk .
-OBJECTIVE	The authors hypothesized that the STRIDE intervention would be more effective than usual care in reducing weight and improving glucose metabolism .
-METHODS	The study design was a multisite , parallel two-arm randomized controlled trial in community settings and an integrated health plan .
-METHODS	Participants who met inclusion criteria were 18 years old , were taking antipsychotic agents for 30 days , and had a body mass index 27 .
-METHODS	Exclusions were significant cognitive impairment , pregnancy/breastfeeding , recent psychiatric hospitalization , bariatric surgery , cancer , heart attack , or stroke .
-METHODS	The intervention emphasized moderate caloric reduction , the DASH ( Dietary Approaches to Stop Hypertension ) diet , and physical activity .
-METHODS	Blinded staff collected data at baseline , 6 months , and 12 months .
-RESULTS	Participants ( men , N = 56 ; women , N = 144 ; mean age = 47.2 years [ SD = 10.6 ] ) were randomly assigned to usual care ( N = 96 ) or a 6-month weekly group intervention plus six monthly maintenance sessions ( N = 104 ) .
-RESULTS	A total of 181 participants ( 90.5 % ) completed 6-month assessments , and 170 ( 85 % ) completed 12-month assessments , without differential attrition .
-RESULTS	Participants attended 14.5 of 24 sessions over 6 months .
-RESULTS	Intent-to-treat analyses revealed that intervention participants lost 4.4 kg more than control participants from baseline to 6 months ( 95 % CI = -6.96 kg to -1.78 kg ) and 2.6 kg more than control participants from baseline to 12 months ( 95 % CI = -5.14 kg to -0.07 kg ) .
-RESULTS	At 12 months , fasting glucose levels in the control group had increased from 106.0 mg/dL to 109.5 mg/dL and decreased in the intervention group from 106.3 mg/dL to 100.4 mg/dL .
-RESULTS	No serious adverse events were study-related ; medical hospitalizations were reduced in the intervention group ( 6.7 % ) compared with the control group ( 18.8 % ) .
-CONCLUSIONS	Individuals taking antipsychotic medications can lose weight and improve fasting glucose levels .
-CONCLUSIONS	Increasing reach of the intervention is an important future step .
-
-###24495287
-BACKGROUND	Verbal autopsy ( VA ) has been proposed to determine the cause of death ( COD ) distributions in settings where most deaths occur without medical attention or certification .
-BACKGROUND	We develop performance criteria for VA-based COD systems and apply these to the Registrar General of India 's ongoing , nationally-representative Indian Million Death Study ( MDS ) .
-METHODS	Performance criteria include a low ill-defined proportion of deaths before old age ; reproducibility , including consistency of COD distributions with independent resampling ; differences in COD distribution of hospital , home , urban or rural deaths ; age - , sex - and time-specific plausibility of specific diseases ; stability and repeatability of dual physician coding ; and the ability of the mortality classification system to capture a wide range of conditions .
-RESULTS	The introduction of the MDS in India reduced the proportion of ill-defined deaths before age 70 years from 13 % to 4 % .
-RESULTS	The cause-specific mortality fractions ( CSMFs ) at ages 5 to 69 years for independently resampled deaths and the MDS were very similar across 19 disease categories .
-RESULTS	By contrast , CSMFs at these ages differed between hospital and home deaths and between urban and rural deaths .
-RESULTS	Thus , reliance mostly on urban or hospital data can distort national estimates of CODs .
-RESULTS	Age - , sex - and time-specific patterns for various diseases were plausible .
-RESULTS	Initial physician agreement on COD occurred about two-thirds of the time .
-RESULTS	The MDS COD classification system was able to capture more eligible records than alternative classification systems .
-RESULTS	By these metrics , the Indian MDS performs well for deaths prior to age 70 years .
-RESULTS	The key implication for low - and middle-income countries where medical certification of death remains uncommon is to implement COD surveys that randomly sample all deaths , use simple but high-quality field work with built-in resampling , and use electronic rather than paper systems to expedite field work and coding .
-CONCLUSIONS	Simple criteria can evaluate the performance of VA-based COD systems .
-CONCLUSIONS	Despite the misclassification of VA , the MDS demonstrates that national surveys of CODs using VA are an order of magnitude better than the limited COD data previously available .
-
-###25409776
-BACKGROUND	Depression accounts for the greatest disease burden of all mental health disorders , contributes heavily to healthcare costs , and by 2020 is set to become the second largest cause of global disability .
-BACKGROUND	Although 10 % to 16 % of people aged 65 years and over are likely to experience depressive symptoms , the condition is under-diagnosed and often inadequately treated in primary care .
-BACKGROUND	Later-life depression is associated with chronic illness and disability , cognitive impairment and social isolation .
-BACKGROUND	With a progressively ageing population it becomes increasingly important to refine strategies to identity and manage depression in older people .
-BACKGROUND	Currently , management may be limited to the prescription of antidepressants where there may be poor concordance ; older people may lack awareness of psychosocial interventions and general practitioners may neglect to offer this treatment option .
-METHODS	CASPER Plus is a multi-centre , randomised controlled trial of a collaborative care intervention for individuals aged 65 years and over experiencing moderate to severe depression .
-METHODS	Selected practices in the North of England identify potentially eligible patients and invite them to participate in the study .
-METHODS	A diagnostic interview is carried out and participants with major depressive disorder are randomised to either collaborative care or usual care .
-METHODS	The recruitment target is 450 participants .
-METHODS	The intervention , behavioural activation and medication management in a collaborative care framework , has been adapted to meet the complex needs of older people .
-METHODS	It is delivered over eight to 10 weekly sessions by a case manager liaising with general practitioners .
-METHODS	The trial aims to evaluate the clinical and cost effectiveness of collaborative care in addition to usual GP care versus usual GP care alone .
-METHODS	The primary clinical outcome , depression severity , will be measured with the Patient Health Questionnaire-9 ( PHQ-9 ) at baseline , 4 , 12 and 18 months .
-METHODS	Cost effectiveness analysis will assess health-related quality of life using the SF-12 and EQ-5D and will examine cost-consequences of collaborative care .
-METHODS	A qualitative process evaluation will be undertaken to explore acceptability , gauge the extent to which the intervention is implemented and to explore sustainability beyond the clinical trial .
-CONCLUSIONS	Results will add to existing evidence and a positive outcome may lead to the commissioning of this model of service in primary care .
-BACKGROUND	ISRCTN45842879 ( 24 July 2012 ) .
-
-###24901823
-BACKGROUND	Endoscopic placement of a iodine-125 radioactive stent is useful to treat obstructive jaundice with unresectable periampullary tumors .
-BACKGROUND	This study aimed to retrospectively evaluate the obstructive component of biliary radioactive stents and discuss the different obstructive mechanism with common plastic stents .
-METHODS	Twenty consecutive patients with malignant obstruction underwent insertion of stents into the common bile duct , including 10 radioactive stents and 10 polyethylene stents .
-METHODS	The radioactive stents were withdrawn after 3 months or earlier if clinical signs suggested stent clogging .
-METHODS	Polyethylene stents were withdrawn after physical signs suggested stent clogging .
-METHODS	Bacteriologic analyses included identification of aerobic and anaerobic bacteria .
-METHODS	Stent surfaces were observed by scanning electron microscopy .
-METHODS	Stent deposition was identified by Fourier-transformed infrared spectroscopy and pyrolysis derivatization/gas chromatography/mass spectrometry .
-RESULTS	Radioactive stent group and polyethylene stent group stents were placed for 86 days ( interquartile range 62 , 114 ) and 146 days ( interquartile range 105 , 181 ) respectively .
-RESULTS	The placement duration of the two types of stents was statistically significant .
-RESULTS	A variety of microorganisms were cultured from the stent deposits .
-RESULTS	Scanning electron microscope images showed a thicker necrotic layer on the external surface of polyethylene stent than the radioactive stent group .
-RESULTS	The proportions of obstructive components in each stent were different , but none of them were statistically significant .
-RESULTS	Necrotic tumor tissue was found in the radioactive stent group .
-CONCLUSIONS	Similar clogging events occurred in both radioactive stents and polyethylene stents .
-CONCLUSIONS	The median duration time of the radioactive stent was shorter , probably because of the smaller inner diameter , and the radioactive seeds exerted no beneficial effect in inhibiting microorganisms .
-
-###24239154
-BACKGROUND	Previous studies on cognitive and interpersonal interventions have yielded inconsistent results in ischemic heart disease patients .
-METHODS	101 patients aged 70 years , and enrolled one week after complete revascularization with urgent/emergent angioplasty for an AMI , were randomized to standard cardiological therapy plus short-term humanistic-existential psychotherapy ( STP ) versus standard cardiological therapy only .
-METHODS	Primary composite end point was : one-year incidence of new cardiological events ( re-infarction , death , stroke , revascularization , life-threatening ventricular arrhythmias , and the recurrence of typical and clinically significant angina ) and of clinically significant new comorbidities .
-METHODS	Secondary end points were : rates for individual components of the primary outcome , incidence of re-hospitalizations for cardiological problems , New York Heart Association class , and psychometric test scores at follow-up .
-RESULTS	94 patients were analyzed at one year .
-RESULTS	The two treatment groups were similar across all baseline characteristics .
-RESULTS	At follow-up , STP patients had had a lower incidence of the primary endpoint , relative to controls ( 21/49 vs. 35/45 patients ; p = 0.0006 , respectively ; NNT = 3 ) ; this benefit was attributable to the lower incidence of recurrent angina and of new comorbidities in the STP group ( 14/49 vs. 22/45 patients , p = 0.04 , NNT = 5 ; and 5/49 vs. 25/45 , p < 0.0001 , NNT = 3 , respectively ) .
-RESULTS	Patients undergoing STP also had statistically fewer re-hospitalizations , a better NYHA class , higher quality of life , and lower depression scores .
-CONCLUSIONS	Adding STP to cardiological therapy improves cardiological symptoms , quality of life , and psychological and medical outcomes one year post AMI , while reducing the need for re-hospitalizations .
-CONCLUSIONS	Larger studies remain necessary to confirm the generalizability of these results .
-BACKGROUND	ClinicalTrial.gov : NCT00769366 .
-
-###24951828
-BACKGROUND	Noroviruses are the most important viral causes of gastroenteritis-related morbidity and mortality .
-BACKGROUND	A randomized , double-blind , placebo-controlled study evaluated an adjuvanted bivalent intramuscular norovirus virus-like particle ( VLP ) vaccine .
-METHODS	Forty-eight adults aged 18-49 years received either 2 doses containing genotype GI .1 VLP and a consensus GII .4 VLP or 2 doses of placebo .
-METHODS	Doses ( 5 g , 15 g , 50 g , or 150 g of each VLP ) were administered 4 weeks apart in the first stage .
-METHODS	Subsequently , 54 adults , aged 18-49 ( n = 16 ) , 50-64 ( n = 19 ) , and 65-85 ( n = 19 ) years , received 2 doses of vaccine containing 50 g of each VLP .
-METHODS	Total and class-specific antibody responses , as well as histoblood group antigen ( HBGA ) blocking antibody responses , were measured before and after each dose .
-RESULTS	Local reactions were mainly injection site pain/tenderness , with no reported fever or vaccine-related serious adverse events .
-RESULTS	One dose of vaccine containing 50 g of each VLP increased GI .1 geometric mean titers ( GMTs ) by 118-fold , 83-fold , and 24-fold and increased GII .4 GMTs by 49-fold , 25-fold , and 9-fold in subjects aged 18-49 , 50-64 , and 65-83 years , respectively .
-RESULTS	Serum antibody responses peaked at day 7 after the first dose , with no evidence of boosting following a second dose .
-RESULTS	Most subjects achieved HBGA-blocking antibody titers of 200 .
-CONCLUSIONS	The vaccine was well tolerated and immunogenic .
-CONCLUSIONS	Rapid immune response to a single dose may be particularly useful in military personnel and travelers and in the control of outbreaks .
-CONCLUSIONS	Clinical Trials Registration.NCT01168401 .
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-###24901635
-BACKGROUND	The threshold values of rapid shallow breathing index ( RSBI ) were compared in pressure support ventilation ( PSV ) and T-piece assessments for spontaneous breathing trials ( SBT ) .
-BACKGROUND	The ability of RSBI to also predict successful weaning was evaluated .
-METHODS	Two hundred eight patients were weaned from mechanical ventilation through oral intubation .
-METHODS	They were randomly divided into PSV group ( n = 93 ) and T-piece group ( n = 115 ) .
-METHODS	The RSBI was calculated as f/VT at SBT of 3 and 30 minutes .
-METHODS	Receiver operating characteristic curves of RSBI were also generated , cutoff values were determined and the changes in the RSBI were calculated .
-RESULTS	Of the 208 patients , 168 ( 80.77 % ) were successfully weaned from mechanical ventilation , 78/93 ( 83.9 % ) in the PSV group and 90/115 ( 78.3 % ) in the T-piece group ( P > 0.05 ) .
-RESULTS	In the PSV and T-piece groups , the average RSBI at 30-minute SBT was 67.18 11.55 breaths per min/L and 99.11 15.53 breaths per min/L , respectively ( P < 0.01 ) , and the average RSBI was 69 33 % and 119 35 % , respectively ( P < 0.01 ) .
-RESULTS	Additionally , in the 2 groups , an RSBI of 75 breaths per min/L ( PSV ) and 100 breaths per min/L ( T-piece ) yielded a diagnostic accuracy of 87 % and 82 % respectively .
-RESULTS	However , a RSBI of 90 % ( PSV ) and 130 % ( T-piece ) yielded a diagnostic accuracy of 82 % and 77 % respectively .
-CONCLUSIONS	The threshold values of RSBI , thus 75 breaths per min/L ( PSV ) and 100 breaths per min/L ( T-piece ) , for predicting successful weaning were more accurate than other values .
-CONCLUSIONS	Similarly , the change in the RSBI could also predict such successes .
-
-###24532547
-BACKGROUND	Continuous long-term treatment with nitrates may cause nitrate tolerance .
-BACKGROUND	Nebivolol is a highly selective beta1-adrenergic antagonist with additional nitric oxide ( NO ) - mediated vasodilatory effects .
-BACKGROUND	However , there have been no investigations into whether or not the long-term administration of nebivolol might cause nitrate tolerance .
-METHODS	We performed a randomized , double-blind , placebo-controlled , cross-over study in 16 healthy men .
-METHODS	Subjects received 5 mg nebivolol or placebo once daily for 8 days in random order divided by a drug-free interval of 2 weeks .
-METHODS	Forearm blood flow ( FBF ) was measured by venous occlusion plethysmography 3 h after oral intake of the first and last doses of nebivolol and placebo , respectively .
-METHODS	FBF was measured again following the intravenous administration of 4 g nitroglycerin/kg body weight/min for 5 min .
-RESULTS	Following 8 days of continuous intake of placebo , nitroglycerin increased FBF by 54 % ( p < 0.05 ) , whereas nitroglycerin increased FBF by 96 % ( p < 0.01 ) following 8 days of continuous intake of nebivolol , and the increase after 8 days of nebivolol was significantly ( p < 0.05 ) more pronounced than after 8 days of placebo .
-CONCLUSIONS	These findings indicate no evidence of nitrate tolerance caused by long-term administration of nebivolol .
-CONCLUSIONS	On the contrary , long-term intake of nebivolol increases rather than decreases the NO-mediated vasodilating effects .
-
-###25230595
-BACKGROUND	Most patients with extensive stage small-cell lung cancer ( ES-SCLC ) who undergo chemotherapy , and prophylactic cranial irradiation , have persistent intrathoracic disease .
-BACKGROUND	We assessed thoracic radiotherapy for treatment of this patient group .
-METHODS	We did this phase 3 randomised controlled trial at 42 hospitals : 16 in Netherlands , 22 in the UK , three in Norway , and one in Belgium .
-METHODS	We enrolled patients with WHO performance score 0-2 and confirmed ES-SCLC who responded to chemotherapy .
-METHODS	They were randomly assigned ( 1:1 ) to receive either thoracic radiotherapy ( 30 Gy in ten fractions ) or no thoracic radiotherapy .
-METHODS	All underwent prophylactic cranial irradiation .
-METHODS	The primary endpoint was overall survival at 1 year in the intention-to-treat population .
-METHODS	Secondary endpoints included progression-free survival .
-METHODS	This study is registered with the Nederlands Trial Register , number NTR1527 .
-RESULTS	We randomly assigned 498 patients between Feb 18 , 2009 , and Dec 21 , 2012 .
-RESULTS	Three withdrew informed consent , leaving 247 patients in the thoracic radiotherapy group and 248 in the control group .
-RESULTS	Mean interval between diagnosis and randomisation was 17 weeks .
-RESULTS	Median follow-up was 24 months .
-RESULTS	Overall survival at 1 year was not significantly different between groups : 33 % ( 95 % CI 27-39 ) for the thoracic radiotherapy group versus 28 % ( 95 % CI 22-34 ) for the control group ( hazard ratio [ HR ] 0.84 , 95 % CI 0.69-1 .01 ; p = 0.066 ) .
-RESULTS	However , in a secondary analysis , 2-year overall survival was 13 % ( 95 % CI 9-19 ) versus 3 % ( 95 % CI 2-8 ; p = 0.004 ) .
-RESULTS	Progression was less likely in the thoracic radiotherapy group than in the control group ( HR 0.73 , 95 % CI 0.61-0 .87 ; p = 0.001 ) .
-RESULTS	At 6 months , progression-free survival was 24 % ( 95 % CI 19-30 ) versus 7 % ( 95 % CI 4-11 ; p = 0.001 ) .
-RESULTS	We recorded no severe toxic effects .
-RESULTS	The most common grade 3 or higher toxic effects were fatigue ( 11 vs 9 ) and dyspnoea ( three vs four ) .
-CONCLUSIONS	Thoracic radiotherapy in addition to prophylactic cranial irradiation should be considered for all patients with ES-SCLC who respond to chemotherapy .
-BACKGROUND	Dutch Cancer Society ( CKTO ) , Dutch Lung Cancer Research Group , Cancer Research UK , Manchester Academic Health Science Centre Trials Coordination Unit , and the UK National Cancer Research Network .
-
-###24781851
-OBJECTIVE	The aim of this study was to test the efficacy of a 12-month lifestyle intervention in improving cardiovascular disease risk factors in community-based menopausal transition and early postmenopausal women in China .
-METHODS	One hundred healthy menopausal transition and early postmenopausal women aged 40 to 60 years were randomly assigned to receive either lifestyle change intervention ( n = 53 ) or usual care ( n = 47 ) .
-METHODS	Menopause status was defined by the menstrual change criteria of the Stages of Reproductive Aging Workshop + 10 based on prospective menstrual calendars .
-METHODS	Women in the intervention group were provided with a colorful booklet that included dietary and physical activity recommendations , were individually interviewed , and completed biophysical cardiovascular risk assessments at the Women 's Health Center ( Beijing , China ) .
-METHODS	Women were encouraged to follow a healthy eating pattern and to increase their aerobic activity ( moderate level , 3 d/wk , 40 min/d ) .
-METHODS	Women in the control group continued their usual eating patterns and activities .
-METHODS	Weight , body mass index ( BMI ) , waist circumference-to-hip circumference ratio ( WHR ) , waist circumference ( WC ) , body composition , blood pressure ( BP ) , blood glucose , and serum lipids were assessed at baseline , 3 months , 6 months , and 12 months in both groups .
-RESULTS	Women in the intervention group were observed to have significant decreases in weight , BMI , WC , WHR , systolic BP , total cholesterol , and low-density lipoprotein cholesterol compared with women in the control group .
-RESULTS	At 3 months , there were significant decreases in weight ( -0.28 vs 0.68 kg , P = 0.002 ) , BMI ( -0.06 vs 0.44 kg/m2 , P = 0.003 ) , WC ( -0.28 vs 1.43 cm , P = 0.001 ) , and WHR ( -0.01 vs 0.01 , P = 0.045 ) in the intervention group compared with the control group .
-RESULTS	At 6 months , there were significant decreases in WC ( -0.73 vs 1.02 cm , P = 0.012 ) , WHR ( -0.02 vs -0.003 , P = 0.020 ) , and systolic BP ( -7.52 vs -0.63 mm Hg , P = 0.012 ) favoring the intervention group over the control group .
-RESULTS	At 12 months , there were significant decreases in total cholesterol ( -0.07 vs 0.03 mmol/L , P = 0.045 ) and low-density lipoprotein cholesterol ( -0.13 vs 0.01 mmol/L , P = 0.022 ) in the intervention group versus the control group .
-CONCLUSIONS	Lifestyle intervention may be an effective means for reducing cardiovascular disease risk factors in menopausal transition and early postmenopausal women in China .
-
-###25005651
-OBJECTIVE	Ninety percent of cases of acute calculous cholecystitis are of mild ( grade I ) or moderate ( grade II ) severity .
-OBJECTIVE	Although the preoperative and intraoperative antibiotic management of acute calculous cholecystitis has been standardized , few data exist on the utility of postoperative antibiotic treatment .
-OBJECTIVE	To determine the effect of postoperative amoxicillin plus clavulanic acid on infection rates after cholecystectomy .
-METHODS	A total of 414 patients treated at 17 medical centers for grade I or II acute calculous cholecystitis and who received 2 g of amoxicillin plus clavulanic acid 3 times a day while in the hospital before and once at the time of surgery were randomized after surgery to an open-label , noninferiority , randomized clinical trial between May 2010 and August 2012 .
-METHODS	After surgery , no antibiotics or continue with the preoperative antibiotic regimen 3 times daily for 5 days .
-METHODS	The proportion of postoperative surgical site or distant infections recorded before or at the 4-week follow-up visit .
-RESULTS	An imputed intention-to-treat analysis of 414 patients showed that the postoperative infection rates were 17 % ( 35 of 207 ) in the nontreatment group and 15 % ( 31 of 207 ) in the antibiotic group ( absolute difference , 1.93 % ; 95 % CI , -8.98 % to 5.12 % ) .
-RESULTS	In the per-protocol analysis , which involved 338 patients , the corresponding rates were both 13 % ( absolute difference , 0.3 % ; 95 % CI , -5.0 % to 6.3 % ) .
-RESULTS	Based on a noninferiority margin of 11 % , the lack of postoperative antibiotic treatment was not associated with worse outcomes than antibiotic treatment .
-RESULTS	Bile cultures showed that 60.9 % were pathogen free .
-RESULTS	Both groups had similar Clavien complication severity outcomes : 195 patients ( 94.2 % ) in the nontreatment group had a score of 0 to I and 2 patients ( 0.97 % ) had a score of III to V , and 182 patients ( 87.8 % ) in the antibiotic group had a score of 0 to I and 4 patients ( 1.93 % ) had a score of III to V.
-CONCLUSIONS	Among patients with mild or moderate calculous cholecystitis who received preoperative and intraoperative antibiotics , lack of postoperative treatment with amoxicillin plus clavulanic acid did not result in a greater incidence of postoperative infections .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01015417 .
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-###25195059
-OBJECTIVE	To expose residents to two methods of education for point-of-care ultrasound , a traditional didactic lecture and a model/simulation-based lecture , which focus on concepts of cardiopulmonary function , volume status , and evaluation of severe thoracic/abdominal injuries ; and to assess which method is more effective .
-METHODS	Single-center , prospective , blinded trial .
-METHODS	University hospital .
-METHODS	Anesthesiology residents who were assigned to an educational day during the two-month research study period .
-METHODS	Residents were allocated to two groups to receive either a 90-minute , one-on-one didactic lecture or a 90-minute lecture in a simulation center , during which they practiced on a human model and simulation mannequin ( normal pathology ) .
-METHODS	Data points included a pre-lecture multiple-choice test , post-lecture multiple-choice test , and post-lecture , human model-based examination .
-METHODS	Post-lecture tests were performed within three weeks of the lecture .
-METHODS	An experienced sonographer who was blinded to the education modality graded the model-based skill assessment examinations .
-METHODS	Participants completed a follow-up survey to assess the perceptions of the quality of their instruction between the two groups .
-RESULTS	20 residents completed the study .
-RESULTS	No differences were noted between the two groups in pre-lecture test scores ( P = 0.97 ) , but significantly higher scores for the model/simulation group occurred on both the post-lecture multiple choice ( P = 0.038 ) and post-lecture model ( P = 0.041 ) examinations .
-RESULTS	Follow-up resident surveys showed significantly higher scores in the model/simulation group regarding overall interest in perioperative ultrasound ( P = 0.047 ) as well understanding of the physiologic concepts ( P = 0.021 ) .
-CONCLUSIONS	A model/simulation-based based lecture series may be more effective in teaching the skills needed to perform a point-of-care ultrasound examination to anesthesiology residents .
-
-###24556773
-OBJECTIVE	Women in academic medicine are not achieving the same career advancement as men , and face unique challenges in managing work and family alongside intense work demands .
-OBJECTIVE	The purpose of this study was to investigate how a supportive department/division culture buffered women from the impact of work demands on work-to-family conflict .
-METHODS	As part of a larger intervention trial , the authors collected baseline survey data from 133 women assistant professors at the University of Pennsylvania Perelman School of Medicine in 2010 .
-METHODS	Validated measures of work demands , work-to-family conflict , and a department/division culture were employed .
-METHODS	Pearson correlations and general linear mixed modeling were used to analyze the data .
-METHODS	Authors investigated whether work culture moderated the association between work demands and work-to-family conflict .
-RESULTS	Heavy work demands were associated with increased levels of work-to-family conflict .
-RESULTS	There were significant interactions between work demands , work-to-family conflict , and department/division culture .
-RESULTS	A culture conducive to women 's academic success significantly moderated the effect of work hours on time-based work-to-family conflict and significantly moderated the effect of work overload on strain-based work-to-family conflict .
-RESULTS	At equivalent levels of work demands , women in more supportive cultures experienced lower levels of work-to-family conflict .
-CONCLUSIONS	The culture of the department/division plays a crucial role in women 's work-to-family conflict and can exacerbate or alleviate the impact of extremely high work demands .
-CONCLUSIONS	This finding leads to important insights about strategies for more effectively supporting the careers of women assistant professors .
-
-###25003264
-BACKGROUND	The addition of glutamine in preoperative drinks may enhance the benefits of carbohydrate alone .
-OBJECTIVE	To evaluate the gastric residual volume after the intake of a beverage containing carbohydrate plus glutamine .
-METHODS	Eleven healthy volunteers ( 24-30 years-old ) were randomized in a crossover fashion to intake 400 mL ( 4h before ) and 200 mL ( 2h before ) of a beverage containing either 12.5 % maltodextrin ( carbohydrate group ) or 12.5 % maltodextrin plus 15 g of glutamine ( glutamine group ) in two different moments 7 days apart .
-METHODS	Magnetic ressonance was performed to measure the gastric residual volume ( mL ) 120 and 180 minutes after the last ingestion .
-RESULTS	Gastric residual volume similar to basal condition was found after 2h and 3h of the intake of beverages .
-RESULTS	There was no difference in the mean SD GRV ( mL ) found at 120 minutes ( carbohydrate group : 22.916.6 and glutamine group : 19.710.7 ) and at 180 minutes ( carbohydrate group : 21.524.1 and glutamine group : 15.110.1 ) between the two drinks .
-CONCLUSIONS	Gastric emptying is efficient , and occurs in up to two hours after the intake of a beverage containing either carbohydrate alone or carbohydrate associated with glutamine .
-CONCLUSIONS	The addition of glutamine to carbohydrate-enriched drink seems to be safe for the use up to 2h before an operation .
-
-###25583168
-BACKGROUND	Little is known about how different antiretrovirals effect inflammation and monocyte activation in human immunodeficiency virus ( HIV ) infection .
-METHODS	We examined plasma specimens obtained during a randomized , double-blinded trial in antiretroviral therapy ( ART ) - naive HIV-infected adults which compared the efficacy of elvitegravir/cobicistat/emtricitabine / tenofovir disoproxil fumarate ( EVG/c/FTC / TDF ) with that of efavirenz/emtricitabine/tenofovir disoproxil fumarate ( EFV/FTC/TDF ) .
-METHODS	From a random sample achieving an HIV type 1 RNA load of < 50 copies/mL by week 48 , changes over 24 and 48 weeks in levels of biomarkers of monocyte activation ( soluble CD14 [ sCD14 ] and soluble CD163 [ sCD163 ] ) , systemic inflammation ( soluble tumor necrosis factor receptor I [ sTNF-RI ] , interleukin 6 [ IL-6 ] , and high-sensitivity C-reactive protein [ hsCRP ] ) , and vascular inflammation ( lipoprotein-associated phospholipase A2 [ Lp-PLA2 ] ) were compared .
-METHODS	Multivariable linear regression was used .
-RESULTS	A total of 200 participants were included .
-RESULTS	Significant differences favoring EVG/c/FTC / TDF were noted for changes in sCD14 , hsCRP , and Lp-PLA2 levels .
-RESULTS	Factors independently associated with a larger decrease in the sCD14 level included random assignment to receive EVG/c/FTC / TDF , higher baseline sCD14 level , and larger decreases in hsCRP and sCD163 levels ; factors associated with a larger Lp-PLA2 decrease included higher baseline Lp-PLA2 and IL-6 levels , smaller increases in total cholesterol and triglycerides levels , a larger decrease in the sCD14 level , and a smaller decrease in the sCD163 level .
-CONCLUSIONS	EVG/c/FTC / TDF led to greater decreases in sCD14 , hsCRP , and Lp-PLA2 levels , compared with EFV/FTC/TDF .
-CONCLUSIONS	Randomization group independently predicted the change in sCD14 level , and changes in monocyte activation independently predicted the change in Lp-PLA2 level .
-CONCLUSIONS	There appears to be a more favorable effect of the integrase inhibitor EVG over efavirenz on immune activation , which may affect vascular inflammation .
-
-###25398967
-BACKGROUND	Vitamin D supplementation may be an inexpensive intervention to reduce heart failure ( HF ) incidence .
-BACKGROUND	However , there are insufficient data to support this hypothesis .
-BACKGROUND	This study evaluates whether vitamin D plus calcium ( CaD ) supplementation is associated with lower rates of HF in postmenopausal women and whether the effects differ between those at high versus low risk for HF .
-RESULTS	Analyses were restricted to 35 983 ( of original 36 282 ) women aged 50 to 79 years old in the Women 's Health Initiative randomized trial of CaD supplementation who were randomized 1:1 in a double-blinded fashion to receive 1000 mg/d of calcium plus 400 IU/d of vitamin D3 or placebo .
-RESULTS	Overall , 744 adjudicated incident HF cases ( intervention , 363 ; control , 381 ) occurred during a median follow-up of 7.1 ( interquartile range , 1.6 ) years .
-RESULTS	CaD supplementation , compared with placebo , was not associated with reduced HF risk in the overall population , hazard ratio , 0.95 ; P = 0.46 .
-RESULTS	However , CaD supplementation had differential effects ( P interaction = 0.005 ) in subgroups stratified by baseline risk status of HF defined by the presence ( high risk = 17 449 ) or absence ( low risk = 18 534 ) of pre-existing HF precursors including coronary heart diseases , diabetes mellitus , or hypertension : 37 % ( hazard ratio , 0.63 [ 95 % confidence interval , 0.46-0 .87 ] ) lower risk of HF in the low-risk versus hazard ratio , 1.06 ; P = 0.51 , in the high-risk subgroups .
-CONCLUSIONS	CaD supplementation did not significantly reduce HF incidence in the overall cohort , however , it was beneficial among postmenopausal women without major HF precursors while of little value in high-risk subgroups .
-CONCLUSIONS	Additional studies are warranted to confirm these findings and investigate the underlying mechanism .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00000611 .
-
-###24401928
-BACKGROUND	Nonpegylated liposomal doxorubicin liposomal doxorubicin , ( Myocet ; Sopherion Therapeutics , Inc Canada , and Cephalon , Europe ) ( NPLD ; Myocet ( ) ) in combination with trastuzumabHerceptin ( ) ( Hoffmann-La Roche ) has shown promising activity and cardiac safety .
-BACKGROUND	We conducted a randomized phase III trial of first-line NPLD plus trastuzumab and paclitaxel ( Pharmachemie B.V. ) ( MTP ) versus trastuzumab plus paclitaxel ( TP ) in patients with human epidermal growth factor 2 receptor ( HER2 ) - positive metastatic breast cancer .
-METHODS	Patients were randomly assigned to NPLD ( M , 50 mg/m ( 2 ) every 3 weeks for six cycles ) , trastuzumab ( T , 4 mg/kg loading dose followed by 2 mg/kg weekly ) , and paclitaxel ( P , 80 mg/m ( 2 ) weekly ) or T + P at the same doses until progression or toxicity .
-METHODS	The primary efficacy outcome was progression-free survival ( PFS ) .
-RESULTS	One hundred and eighty-one patients were allocated to receive MTP , and 183 to TP .
-RESULTS	Median PFS was 16.1 and 14.5 months with MTP and TP , respectively [ hazard ratio ( HR ) 0.84 ; two-sided P = 0.174 ] .
-RESULTS	In patients with estrogen receptor ( ER ) - and progesterone receptor ( PR ) - negative tumors , PFS was 20.7 and 14.0 months , respectively [ HR 0.68 ; 95 % confidence interval ( CI ) 0.47-0 .99 ] .
-RESULTS	Median overall survival ( OS ) was 33.6 and 28.9 months with MTP and TP , respectively ( HR 0.79 ; two-sided P = 0.083 ) .
-RESULTS	In ER - and PR-negative tumors , OS was 38.2 and 27.9 months , respectively ( HR 0.63 ; 95 % CI 0.42-0 .93 ) .
-RESULTS	The frequency of adverse events was higher with MTP , but there was no significant difference in cardiac toxicity between treatment arms .
-CONCLUSIONS	The trial failed to demonstrate a significant clinical improvement with the addition of M to TP regimen .
-CONCLUSIONS	The clinical benefit observed in an exploratory analysis in the ER - and PR-negative population deserves consideration for further clinical trials .
-BACKGROUND	NCT00294996 .
-
-###24581132
-OBJECTIVE	To evaluate the efficacy of reflex entropy ( RE ) / state entropy ( SE ) in monitoring the response to nociceptive stimulus during propofol-remifentanil infusion .
-METHODS	After the approval of the hospital ethics committee , sixty American Society of Anesthesiologists ( ASA ) classification 1-2 patients , aged 18-65 years , receiving the hypogastrium operation undergoing general anesthesia , were randomly allocated to groups A and B with different remifentanil concentrations .
-METHODS	After the concentration of propofol and remifentanil reached balance , tetanic stimulation , intubation , and incision were performed respectively with certain intervals .
-METHODS	RE and SE were monitored during this procedure .
-RESULTS	Twelve patients were withdrawn from this study due to the use of vasoactive drugs .
-RESULTS	Finally , there were 28 cases in group A and 20 cases in group B.
-RESULTS	The RE and SE were not significantly changed before and after the tetanic stimulation in both groups ( all P > 0.05 ) .
-RESULTS	Both RE and SE were significantly increased after intubation in group B ( both P < 0.05 ) and after skin incision in both groups ( all P < 0.05 ) .
-RESULTS	Under the same stimulation , RE and SE showed no significant difference among groups administered with different levels of remifentanil ( P > 0.05 ) .
-CONCLUSIONS	Under the anesthesia with propofol + remifentanil , nociceptive response may cause the increase of RE and SE .
-CONCLUSIONS	Therefore , RE and SE may be useful parameters for monitoring the nociceptive response during general anaesthesia .
-
-###24373326
-OBJECTIVE	To compare the outcome of deep sclerectomy ( DS ) with and without mitomycin-C ( MMC ) in patients with normal-tension glaucoma ( NTG ) .
-METHODS	We prospectively analysed the results of 37 eyes of 37 consecutive patients with NTG ( age ; mean SD ; 64 7 years ) who underwent DS with a collagen implant .
-METHODS	Patients were randomized to the MMC and non-MMC groups .
-METHODS	Subconjunctival MMC ( 0.4 mg/ml for 3 min ) was used intraoperatively in 15 of 37 eyes .
-METHODS	We defined total success as 25 % reduction in intraocular pressure ( IOP ) without medication .
-METHODS	Follow-up time was 12 months .
-RESULTS	The mean preoperative IOP was significantly reduced from 15.2 2.8 mmHg to 9.3 2.7 ( p < 0.001 ) in the MMC group after 12-month follow-up and from 15.1 2.9 mmHg to 11.8 2.0 ( p < 0.001 ) in the non-MMC group .
-RESULTS	At 12 months , the mean IOP was significantly lower in the MMC group ( p = 0.003 ) compared with the non-MMC group .
-RESULTS	Total success was achieved in 10 of 15 eyes ( 67 % ) in MMC group and in nine of 22 eyes ( 41 % ) in non-MMC group ( p = 0.12 ) .
-RESULTS	The number of glaucoma medications was decreased from 2.2 0.8 to 0.5 1.2 in MMC group ( p = 0.001 ) and from 2.6 1.0 to 0.5 0.7 in non-MMC group ( p < 0.001 ) .
-RESULTS	Goniopuncture was performed in seven eyes ( 47 % ) in the MMC group , compared with 16 eyes ( 73 % ) in the non-MMC group ( p = 0.13 ) .
-RESULTS	IOP < 10 mmHg was achieved in seven of 15 eyes in the MMC group and in two of 22 in the non-MMC group ( p = 0.009 ) .
-RESULTS	Complication rate was low , and no difference between groups was evident .
-CONCLUSIONS	Deep sclerectomy seems to be effective and safe in reducing IOP in patients with NTG .
-CONCLUSIONS	Intraoperative use of MMC results in lower postoperative IOP 12-month postoperatively without increased rate of complications .
-
-###24634346
-OBJECTIVE	Vent-HeFT is a multicentre randomized trial designed to investigate the potential additive benefits of inspiratory muscle training ( IMT ) on aerobic training ( AT ) in patients with chronic heart failure ( CHF ) .
-RESULTS	Forty-three CHF patients with a mean age of 5812 years , peak oxygen consumption ( peak VO2 ) 17.95 mL/kg/min , and LVEF 29.55 % were randomized to an AT/IMT group ( n = 21 ) or to an AT/SHAM group ( n = 22 ) in a 12-week exercise programme .
-RESULTS	AT involved 45 min of ergometer training at 70-80 % of maximum heart rate , three times a week for both groups .
-RESULTS	In the AT/IMT group , IMT was performed at 60 % of sustained maximal inspiratory pressure ( SPImax ) while in the AT/SHAM group it was performed at 10 % of SPImax , using a computer biofeedback trainer for 30 min , three times a week .
-RESULTS	At baseline and at 3 months , patients were evaluated for exercise capacity , lung function , inspiratory muscle strength ( PImax ) and work capacity ( SPImax ) , quality of life ( QoL ) , LVEF and LV diameter , dyspnoea , C-reactive protein ( CRP ) , and NT-proBNP .
-RESULTS	IMT resulted in a significantly higher benefit in SPImax ( P = 0.02 ) , QoL ( P = 0.002 ) , dyspnoea ( P = 0.004 ) , CRP ( P = 0.03 ) , and NT-proBNP ( P = 0.004 ) .
-RESULTS	In both AT/IMT and AT/SHAM groups PImax ( P < 0.001 , P = 0.02 ) , peak VO2 ( P = 0.008 , P = 0.04 ) , and LVEF ( P = 0.005 , P = 0.002 ) improved significantly ; however , without an additional benefit for either of the groups .
-CONCLUSIONS	This randomized multicentre study demonstrates that IMT combined with aerobic training provides additional benefits in functional and serum biomarkers in patients with moderate CHF .
-CONCLUSIONS	These findings advocate for application of IMT in cardiac rehabilitation programmes .
-
-###25571933
-BACKGROUND	Anaesthetists may fail to recognize and manage certain rare intraoperative events .
-BACKGROUND	Simulation has been shown to be an effective educational adjunct to typical operating room-based education to train for these events .
-BACKGROUND	It is yet unclear , however , why simulation has any benefit .
-BACKGROUND	We hypothesize that learners who are allowed to manage a scenario independently and allowed to fail , thus causing simulated morbidity , will consequently perform better when re-exposed to a similar scenario .
-METHODS	Using a randomized , controlled , observer-blinded design , 24 first-year residents were exposed to an oxygen pipeline contamination scenario , either where patient harm occurred ( independent group , n = 12 ) or where a simulated attending anaesthetist intervened to prevent harm ( supervised group , n = 12 ) .
-METHODS	Residents were brought back 6 months later and exposed to a different scenario ( pipeline contamination ) with the same end point .
-METHODS	Participants ' proper treatment , time to diagnosis , and non-technical skills ( measured using the Anaesthetists ' Non-Technical Skills Checklist , ANTS ) were measured .
-RESULTS	No participants provided proper treatment in the initial exposure .
-RESULTS	In the repeat encounter 6 months later , 67 % in the independent group vs 17 % in the supervised group resumed adequate oxygen delivery ( P = 0.013 ) .
-RESULTS	The independent group also had better ANTS scores [ median ( interquartile range ) : 42.3 ( 31.5-53 .1 ) vs 31.3 ( 21.6-41 ) , P = 0.015 ] .
-RESULTS	There was no difference in time to treatment if proper management was provided [ 602 ( 490-820 ) vs 610 ( 420-800 ) s , P = 0.79 ] .
-CONCLUSIONS	Allowing residents to practise independently in the simulation laboratory , and subsequently , allowing them to fail , can be an important part of simulation-based learning .
-CONCLUSIONS	This is not feasible in real clinical practice but appears to have improved resident performance in this study .
-CONCLUSIONS	The purposeful use of independent practice and its potentially negative outcomes thus sets simulation-based learning apart from traditional operating room learning .
-
-###25157013
-OBJECTIVE	Cardiovascular disease ( CVD ) and underlying atherosclerosis begin in childhood and are related to CVD risk factors .
-OBJECTIVE	This study evaluates tools and strategies to enhance adoption of new CVD risk reduction guidelines for children .
-METHODS	Thirty-two practices , recruited and supported by 2 primary care research networks , were cluster randomized to a multifaceted controlled intervention .
-METHODS	Practices were compared with guideline-based individual and composite measures for BMI , blood pressure ( BP ) , and tobacco .
-METHODS	Composite measures were constructed by summing the numerators and denominators of individual measures .
-METHODS	Preintervention and postintervention measures were assessed by medical record review of children ages 3 to 11 years .
-METHODS	Changes in measures ( pre-post and intervention versus control ) were compared .
-RESULTS	The intervention group BP composite improved by 29.5 % , increasing from 49.7 % to 79.2 % , compared with the control group ( 49.5 % to 49.6 % ; P < .001 ) .
-RESULTS	Intervention group BP interpretation improved by 61.1 % ( from 0.2 % to 61.3 % ) , compared with the control group ( 0.4 % to 0.6 % ; P < .001 ) .
-RESULTS	The assessment of tobacco exposure or use for 5 - to 11-year-olds in the intervention group improved by 30.3 % ( from 3.4 % to 49.1 % ) versus the control group ( 0.6 % to 21.4 % ) ( P = .042 ) .
-RESULTS	No significant change was seen in the BMI or tobacco composites measures .
-RESULTS	The overall composite of 9 measures improved by 13.4 % ( from 48.2 % to 69.8 % ) for the intervention group versus the control group ( 47.4 % to 55.2 % ) ( P = .01 ) .
-CONCLUSIONS	Significant improvement was demonstrated in the overall composite measure , the composite measure of BP , and tobacco assessment and advice for children aged 5 to 11 years .
-
-###24452810
-OBJECTIVE	Veliparib ( ABT-888 ) is a potent oral inhibitor of Poly ( ADP-ribose ) polymerase enzyme that is currently in development for the treatment of non-hematologic and hematologic malignancies .
-OBJECTIVE	This analysis characterizes the population pharmacokinetics of veliparib , including developing a structural pharmacokinetic model and testing patient demographics and covariates for potential influence on veliparib pharmacokinetics in patients with non-hematologic malignancies .
-METHODS	The analysis dataset included 3,542 veliparib concentration values from 325 patients with non-hematologic malignancies enrolled in three phase I and one phase II studies .
-METHODS	Population pharmacokinetic modeling was performed using NONMEM .
-METHODS	The likelihood ratio test was used for comparison of nested models , and visual predictive check was employed for model qualification .
-METHODS	Covariates tested included body size measures , creatinine clearance ( CLCR ) , formulation , age , sex , race , liver function tests , and coadministration with temozolomide .
-RESULTS	A one-compartment model with first-order absorption and elimination adequately described veliparib pharmacokinetics .
-RESULTS	The final model included fixed effects for CLCR on veliparib oral clearance ( CL/F ) and lean body mass ( LBM ) on volume of distribution ( V d/F ) .
-RESULTS	CL/F and V d/F were 20.9 L/h ( for a CLCR of 100 mL/min ) and 173 L ( for an LBM of 56 kg ) , respectively .
-CONCLUSIONS	Only LBM and CLCR were found to be determinants of veliparib V d/F and CL/F , respectively .
-CONCLUSIONS	Dosage adjustments of veliparib on the basis of body size , age , sex , race , liver function , and temozolomide coadministration are not necessary in patients with non-hematologic malignancies .
-CONCLUSIONS	This is the first study to characterize the population pharmacokinetics of veliparib , and the developed model will be used to conduct simulations and evaluate veliparib exposure-response relationships .
-
-###25516139
-OBJECTIVE	To determine whether supplementation with vitamin D improves resilience to the adverse effects of earthquakes .
-METHODS	Opportunistic addition to an established randomised double blind placebo controlled trial .
-METHODS	Christchurch , New Zealand , where a prolonged series of catastrophic earthquakes beginning on 4 September 2010 occurred , which caused widespread destruction , fatalities , and extensive psychological damage .
-METHODS	322 healthy adults ( 241 women ; 81 men ) aged 18-67 who were already participating in the vitamin D and acute respiratory infections study ( VIDARIS ) between February 2010 and November 2011 .
-METHODS	Participants were randomised to receive an oral dose of either 200,000 IU vitamin D3 monthly for two months then 100,000 IU monthly ( n = 161 ) or placebo ( n = 161 ) for a total of 18 months .
-METHODS	This is a post hoc analysis from the previously published VIDARIS trial .
-METHODS	The primary endpoint in the current analysis was the self reported effects and overall adverse impact of the Christchurch earthquakes as assessed by questionnaire four months after the most destructive earthquake on 22 February 2011 , which was used as the index event .
-METHODS	The secondary end point was the number of `` psychological '' adverse events that participants reported at their usual monthly appointments as part of the original VIDARIS trial .
-RESULTS	308 participants completed the earthquake impact questionnaire ( n = 152 in the vitamin D group and 156 in the placebo group ) .
-RESULTS	There was no significant difference in the number of self reported adverse effects between those receiving vitamin D supplementation and those receiving placebo .
-RESULTS	There was also no difference in the overall adverse impact score between treatment groups ( ( 2 ) P = 0.44 ) .
-RESULTS	The exception was that those in the vitamin D group experienced more adverse effects on family relationships ( 22 % v 13 % ; ( 2 ) P = 0.03 ) .
-RESULTS	The number of psychological adverse events-such as fatigue , stress , anxiety , and insomnia-that participants reported at their usual monthly appointments was significantly higher after the earthquake ( ( 2 ) P = 0.007 ) but did not differ between treatment groups .
-CONCLUSIONS	In this trial , vitamin D supplementation did not reduce the adverse impact of earthquakes in healthy adults .
-CONCLUSIONS	Trial registration Australian New Zealand Clinical Trials Registry ( anzctr.org.au ) ACTRN12609000486224 .
-
-###24297951
-OBJECTIVE	Cumulative neurotoxicity is a prominent toxicity of oxaliplatin-based therapy .
-OBJECTIVE	Intravenous calcium and magnesium have been extensively used to reduce oxaliplatin-induced neurotoxicity .
-OBJECTIVE	This trial was designed to definitively test whether calcium/magnesium decreases oxaliplatin-related neurotoxicity .
-METHODS	In all , 353 patients with colon cancer undergoing adjuvant therapy with FOLFOX ( fluorouracil , leucovorin , and oxaliplatin ) were randomly assigned to intravenous calcium/magnesium before and after oxaliplatin , a placebo before and after , or calcium/magnesium before and placebo after .
-METHODS	The primary end point was cumulative neurotoxicity measured by the sensory scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20 tool .
-RESULTS	There were no statistically significant neuropathy differences among the study arms as measured by the primary end point or additional measures of neuropathy , including clinician-determined measurement of the time to grade 2 neuropathy by using the National Cancer Institute Common Terminology Criteria for Adverse Events scale or an oxaliplatin-specific neuropathy scale .
-RESULTS	In addition , calcium/magnesium did not substantially decrease oxaliplatin-induced acute neuropathy .
-CONCLUSIONS	This study does not support using calcium/magnesium to protect against oxaliplatin-induced neurotoxicity .
-
-###24978428
-OBJECTIVE	To evaluate the effects of 0.3 mg or 0.5 mg of ranibizumab in eyes with macular telangiectasia type 2 without subretinal neovascularization .
-METHODS	Ten eyes were randomized to either 0.3 mg or 0.5 mg ranibizumab group in 1 eye only .
-METHODS	Study eye received ranibizumab at baseline and at Months 1 and 2 .
-METHODS	Injections at Months 3 , 4 , and 5 were at investigator 's discretion .
-METHODS	Participants were followed monthly through 6 months with best-corrected visual acuity , fluorescein angiography , and optical coherence tomography .
-RESULTS	For study eyes at baseline , median best-corrected visual acuity letter score was 60 ( 20/64 Snellen equivalent ) and central subfield retinal thickness was 181.5 m. Median number of injections was six .
-RESULTS	Median change in best-corrected visual acuity at Month 3 was 4 letters ( range : -5 to 9 letters ) at both doses in the study eye and 3 letters ( range : -10 to 5 letters ) in the untreated fellow eye .
-RESULTS	At Month 3 , retinal leakage decreased 0.87 disk area and 0.76 disk area for 0.3 mg and 0.5 mg ranibizumab , respectively .
-RESULTS	Median change in central subfield retinal thickness was 1 m and -11 m for 0.3 mg and 0.5 mg ranibizumab , respectively .
-CONCLUSIONS	Ranibizumab ( 0.3 mg or 0.5 mg ) decreases leakage secondary to macular telangiectasia type 2 , but accompanying improvements in best-corrected visual acuity appear similar to improvements in the untreated fellow eye where retinal thickness is relatively unchanged .
-
-###25552615
-BACKGROUND	Patients with transient ischaemic attack ( TIA ) or stroke are at risk for cognitive impairment and dementia .
-BACKGROUND	Currently , there is no known effective strategy to prevent this cognitive decline .
-BACKGROUND	Increasing evidence exists that physical exercise is beneficial for cognitive function .
-BACKGROUND	However , in patients with TIA or stroke who are at risk of cognitive impairment and dementia , only a few trials have been conducted .
-BACKGROUND	In this study , we aim to investigate whether a physical exercise programme ( MoveIT ) can prevent cognitive decline in patients in the acute phase after a TIA or minor ischaemic stroke .
-METHODS	A single-blinded randomised controlled trial will be conducted to investigate the effect of an aerobic exercise programme on cognition compared with usual care .
-METHODS	120 adult patients with a TIA or minor ischaemic stroke less than 1 month ago will be randomly allocated to an exercise programme consisting of a 12-week aerobic exercise programme and regular follow-up visits to a specialised physiotherapist during the period of 1 year or to usual care .
-METHODS	Outcome measures will be assessed at the baseline , and at the 1-year and 2-year follow-up .
-METHODS	The primary outcome is cognitive functioning measured with the Montreal Cognitive Assessment ( MoCA ) test and with additional neuropsychological tests .
-METHODS	Secondary outcomes include maximal exercise capacity , self-reported physical activity and measures of secondary prevention .
-BACKGROUND	The study received ethical approval from the VU University Amsterdam Ethics committee ( 2011/383 ) .
-BACKGROUND	The results of this study will be published in peer-reviewed journals and presented at international conferences .
-BACKGROUND	We will also disseminate the main results to our participants in a letter .
-BACKGROUND	The Nederlands Trial Register NTR3884 .
-
-###24816689
-OBJECTIVE	To compare staples with subcuticular sutures for skin closure in emergency Cesarean sections ( CS ) .
-METHODS	One hundred and thirty women ( undergoing emergency CS without previous abdominal delivery ) were randomly assigned to either staples or subcuticular skin closure ( monocryl 3-0 ) .
-METHODS	Primary outcome of the study was cosmetic outcome [ as assessed by patient and independent observer : Patient Scar Assessment Scale ( PSAS ) and Observer Scar Assessment Scale ( OSAS ) , respectively ] , 6weeks post-operative .
-METHODS	Secondary outcomes were wound complications , operating time , post-operative pain ( visual analogue scale day 3 post-operative and patient assessment of pain in scar 6weeks post-operative ) , and duration of hospital stay .
-RESULTS	112 women were available for evaluation of scar 6weeks post-operative .
-RESULTS	Cosmetic result of staples was significantly better than subcuticular sutures ( PSAS and OSAS : p value 0.022 and 0.000 , respectively ) , with significantly lesser duration of surgery ( 24 vs. 32min : p value 0.000 ) and comparable post-operative pain ( pain on day 3 and 6weeks post-operatively : p value 0.474 and 0.179 , respectively ) and wound complications ( p value 0.737 ) .
-RESULTS	However , duration of stay in hospital was increased ( 6 vs. 3days : p value 0.001 ) .
-CONCLUSIONS	Staples are the method of choice for skin closure in emergency CS as they are significantly better than subcuticular sutures with respect to cosmesis and duration of surgery .
-CONCLUSIONS	Post-operative pain and wound complications are comparable in two groups .
-CONCLUSIONS	However , staples are associated with significantly increased duration of hospital stay .
-CONCLUSIONS	Trial registered in clinical trial registry CTRI : REF/2013/05 / 005087 .
-
-###25429720
-BACKGROUND	Chronic thoracic pain after cardiac surgery is prevalent ( 11 to 56 % ) and may affect patients ' physical and mental health status .
-BACKGROUND	Despite its favorable pharmacokinetic and pharmacodynamic properties , high doses of remifentanil administered during surgery are reported to cause acute postoperative pain and increased requirements for analgesics .
-BACKGROUND	Recently , an association between remifentanil use and the incidence of chronic thoracic pain in the long term was also reported .
-BACKGROUND	Our objective is to investigate the influence of the intraoperative remifentanil on chronic postoperative pain in a prospective randomized controlled trial .
-METHODS	In this prospective , randomized , single-blind clinical trial , all patients ( N = 126 ) between 18 and 85 years undergoing cardiac surgery via sternotomy receive a continuous infusion of propofol together with intermittent intravenous fentanyl at predetermined times perioperatively .
-METHODS	Patients are randomized to receive either an additional continuous infusion of remifentanil ( 0.15 g ( -1 ) kgIBW ( -1 ) min ( -1 ) ) or additional fentanyl ( 200 to 500 g ) as needed during surgery.The primary end point is the prevalence of chronic thoracic pain 12 months after surgery .
-METHODS	Secondary end points include acute postoperative pain ; postoperative analgesic use ; chronic thoracic pain 3 and 6 months after surgery ; quality of life ( SF-12 ) at 3 , 6 and 12 months after surgery ; work productivity ; and use of health care .
-METHODS	In addition , thermal detection and pain thresholds are measured preoperatively , 3 days after surgery and 12 months after surgery using quantitative sensory testing ( QST ) .
-METHODS	Finally , the influence of several genetic variances on the different outcomes will be measured .
-CONCLUSIONS	Chronic thoracic pain is prevalent after cardiac surgery , and research is needed to minimize the risk of chronic persistent postoperative pain , which is an invalidating , long-term complication of surgery .
-CONCLUSIONS	The objective of this trial is to determine the influence of perioperative remifentanil on long-term pain outcomes for cardiac patients in a prospective randomized trial .
-CONCLUSIONS	The results may be used to optimize perioperative analgesia techniques and , thereby , improve quality of life after cardiac surgery .
-BACKGROUND	Clinicaltrials.gov NCT02031016 on 13 December 2013 .
-
-###25042932
-OBJECTIVE	To develop a reliable and safe laryngeal nerve conduction technique and to obtain consistent parameters as normal reference values .
-METHODS	A prospective single-arm study .
-METHODS	A nerve conduction test was performed on the contralateral normal side in 42 patients with unilateral vocal fold palsy .
-METHODS	The recording was performed in the intact thyroarytenoid muscle using a monopolar needle .
-METHODS	The electrical stimulation using a 37-mm monopolar needle was applied 3 cm below the lower margin of the cricoid cartilage , just lateral to the trachea and medial to the carotid artery , and its intensity was gradually increased until the amplitude of the electrical response reached the maximum level .
-METHODS	The latency of the evoked muscle response was acquired at the first evoked waveform deflection from the baseline .
-RESULTS	The average latency of the recurrent laryngeal nerves was 1.980.26 ms. The latencies showed normal distribution according to the quantile-quantile plot and Kolmogorov-Smirnov test ( P = .098 ) .
-RESULTS	There was no significant difference in latencies between the right and left recurrent laryngeal nerves .
-RESULTS	Anthropometric factors including height and weight did not show any correlation with the latencies .
-CONCLUSIONS	We developed a reliable and safe laryngeal nerve conduction technique and obtained normal reference values for the recurrent laryngeal nerve conduction study .
-CONCLUSIONS	This laryngeal nerve conduction study can be an additional tool for detecting recurrent laryngeal nerve injury if it is performed in combination with the conventional laryngeal electromyography .
-METHODS	4 .
-
-###25012422
-OBJECTIVE	Because increased dopamine neurotransmission occurs with most antidepressants , and because antipsychotics cause behavioural supersensitivity to dopamine , short-term low-dose antipsychotic treatment was tested on depressed patients with an expectation of clinical improvement in the supersensitive phase following drug withdrawal .
-METHODS	This was a randomized , double-blind , placebo-controlled study of 48 patients who met criteria for DSM-IV ( ) Major Depressive Disorder , were in a Major Depressive Episode , and had a Hamilton Depression Rating Scale ( HAMD ) rating of 14 .
-METHODS	Half the participants received 0.25 mg oral haloperidol each day for 7 days , after which they received placebo daily for 4 weeks .
-METHODS	The other half received placebo throughout the trial .
-RESULTS	One week after stopping the medication , the HAMD ratings of the drug-treated patients fell by 9.96 points , as compared to a reduction of 8.73 points in the placebo-treated patients , when comparing visits 1 and 4 .
-RESULTS	There was no such difference when comparing visits 2 and 4 .
-RESULTS	The differences were not significant , but indicated a trend .
-RESULTS	One week after the medication was stopped , the Clinical Global Index fell 1.640.18 units for the medication-treated patients , compared to 1.120.26 units for the placebo group ( P = 0.05 ) .
-RESULTS	The regimen was well tolerated .
-CONCLUSIONS	Seven days of an ultra-low dose of 0.25 mg haloperidol , followed by withdrawal of haloperidol , resulted in clinical depression improvement greater than placebo and significantly decreased psychomotor retardation , consistent with haloperidol-induced behavioural supersensitivity to dopamine .
-CONCLUSIONS	The sample was small .
-CONCLUSIONS	More patients are needed in a future study .
-
-###25261241
-OBJECTIVE	To determine whether stereopsis of infants treated for monocular cataracts varies with the type of optical correction used .
-METHODS	Randomized prospective clinical trial .
-METHODS	The Infant Aphakia Treatment Study randomized 114 patients with unilateral cataracts at age 1-7 months to either primary intraocular lens ( IOL ) or contact lens correction .
-METHODS	At 4.5 years of age a masked examiner assessed stereopsis on these patients using 3 different tests : ( 1 ) Frisby ; ( 2 ) Randot Preschool ; and ( 3 ) Titmus Fly .
-RESULTS	Twenty-eight patients ( 25 % ) had a positive response to at least 1 of the stereopsis tests .
-RESULTS	There was no statistically significant difference in stereopsis between the 2 treatment groups : Frisby ( contact lens , 6 [ 11 % ] ; IOL , 7 [ 13 % ] ; P = .99 ) , Randot ( contact lens , 3 [ 6 % ] ; IOL , 1 [ 2 % ] ; P = .62 ) , or Titmus ( contact lens , 8 [ 15 % ] ; IOL , 13 [ 23 % ] ; P = .34 ) .
-RESULTS	The median age at surgery for patients with stereopsis was younger than for those without stereopsis ( 1.2 vs 2.4 months ; P = .002 ) .
-RESULTS	The median visual acuity for patients with stereopsis was better than for those without stereopsis ( 20/40 vs 20/252 ; P = .0003 ) .
-CONCLUSIONS	The type of optical correction did not influence stereopsis outcomes .
-CONCLUSIONS	However , 2 other factors did : age at surgery and visual acuity in the treated eye at age 4.5 years .
-CONCLUSIONS	Early surgery for unilateral congenital cataract and the presence of visual acuity better than or equal to 20/40 appear to be more important than the type of initial optical correction used for the development of stereopsis .
-
-###24875781
-BACKGROUND	Although the rate of bleeding among patients with atrial fibrillation ( AF ) taking novel oral anticoagulants in randomized controlled trials is described , the rate of bleeding with `` real-world '' use is uncertain .
-METHODS	We conducted a retrospective electronic medical record interrogation and subsequent chart review among patients within Intermountain Healthcare between October 2010 and November 2012 .
-METHODS	Patients were included if they had a diagnosis of AF and were receiving either dabigatran or rivaroxaban .
-METHODS	Rates of major bleeding were calculated .
-RESULTS	Among 2579 patients , 13 ( 0.5 % ) experienced major bleeding ( 95 % confidence interval [ CI ] 0.23-0 .77 ) , 5 ( 0.19 % ) experienced intracranial hemorrhage ( 95 % CI 0.02-0 .36 ) , and 2 ( 0.08 % ) experienced fatal bleeding .
-RESULTS	Of the 13 patients experiencing a major bleed , 8 ( 61.5 % ) would have been excluded from the Randomized Evaluation of Long-Term Anticoagulation Therapy ( RE-LY ) and Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for prevention of Stroke and Embolism Trial in Atrial Fibrillation ( ROCKET AF ) clinical trials .
-CONCLUSIONS	We observed a rate of major bleeding similar to that reported in randomized clinical trials among patients with AF prescribed dabigatran or rivaroxaban .
-
-###25409911
-BACKGROUND	Psychosocial problems are highly prevalent among Dutch adolescents .
-BACKGROUND	We have conducted a trial to test whether offering chat-based consultations could be of added value within the context of Dutch Youth Health Care .
-BACKGROUND	This trial was ended prematurely because of recruitment issues .
-BACKGROUND	The aim of this study is to learn from this failed trial and to provide more insight into non-participation .
-BACKGROUND	Sources of data were non-participation forms , oral clarification , patient records , telephone interviews with adolescents that declined to participate , and a questionnaire-based process evaluation among nurses .
-RESULTS	Non-participation appears to be a multi-factorial problem .
-RESULTS	Of those 290 adolescents eligible to participate , the majority ( n = 165 , 57 % ) declined to do so .
-RESULTS	Two-third of those ( n = 109 ) also refused usual care , which might be indicative of not wanting help and/or experiencing problems and the validity of the assessment instrument .
-RESULTS	The other one-third ( n = 56 ) did enrol in usual care and indicated other reasons for non-participation , such as a preference for face-to-face consultations , the extensive information that was provided , and not liking the idea of being randomized .
-CONCLUSIONS	This study shows that even if a trial fails , we can learn about the challenges of recruiting adolescents in intervention trials .
-BACKGROUND	NL37668 .068.11 / METC11-3-077 .
-
-###25046949
-OBJECTIVE	To investigate the therapeutic effect of Yiqi Huaju Recipe ( YHR ) combined with routine therapy on the blood pressure , the blood pressure variability and other cardiovascular risk factors in hypertension patients complicated with metabolic syndrome ( MetS ) .
-METHODS	Totally 43 hypertension patients complicated with MetS were recruited in this study and randomly assigned to the treatment group ( 22 cases , treated with basic routine treatment + YHR ) and the control group ( 21 cases , treated with basic routine treatment + placebo ) .
-METHODS	The treatment course was 12 weeks .
-METHODS	Detected were parameters such as 24-h ambulatory blood pressure monitoring ( ABPM ) , body mass index ( BMI ) , waist circumference ( WC ) , waist to hip ratio ( WHR ) , homeostatic model assessment for insulin resistance ( HOMA-IR ) , fasting glycosylated hemoglobin A1c ( HbA1c ) , fasting plasma glucose ( FPG ) , 2 h postprandial plasma glucose ( 2 h PPG ) , fasting plasma insulin ( FPI ) , serum lipid , etc. .
-RESULTS	The anthropometric parameters and plasma glucose levels ( except HbAlc ) were obviously lowered after treatment than before treatment in the treatment group ( P < 0.01 , P < 0.05 ) .
-RESULTS	Besides , better effects were obtained in the WC , WHR , 2 h PPG , FPI and HOMA-IR ( P < 0.05 ) .
-RESULTS	The average blood pressure amplitude , the blood pressure variability , and blood pressure load at any time point were more obviously improved in the two groups after treatment than before treatment ( P < 0.01 , P < 0.05 ) .
-RESULTS	Besides , partial indices were better in the treatment group than in the control group ( P < 0.01 , P < 0.05 ) .
-CONCLUSIONS	YHR combined with routine therapy exhibited better effect on reducing the blood pressure amplitude , the blood pressure variability , and the blood pressure load in hypertension patients complicated with MetS .
-CONCLUSIONS	It could also effectively decrease the risk of other vascular disease .
-
-###24980066
-OBJECTIVE	Whether there are age-related changes in slow wave activity ( SWA ) rise time , a marker of homeostatic sleep drive , is unknown .
-OBJECTIVE	Additionally , although sleep medication use is highest among older adults , the quantitative electroencephalographic ( EEG ) profile of the most commonly prescribed sleep medication , zolpidem , in older adults is also unknown .
-OBJECTIVE	We therefore quantified age-related and regional brain differences in sleep EEG with and without zolpidem .
-METHODS	Thirteen healthy young adults aged 21.92.2 years and 12 healthy older adults aged 67.44.2 years participated in a randomized , double-blind , within-subject study that compared placebo to 5mg zolpidem .
-RESULTS	Older adults showed a smaller rise in SWA and zolpidem increased age-related differences in SWA rise time such that age differences were observed earlier after latency to persistent sleep .
-RESULTS	Age-related differences in EEG power differed by brain region .
-RESULTS	Older , but not young , adults showed zolpidem-dependent reductions in theta and alpha frequencies .
-RESULTS	Zolpidem decreased stage 1 in older adults and did not alter other age-related sleep architecture parameters .
-CONCLUSIONS	SWA findings provide additional support for reduced homeostatic sleep drive or reduced ability to respond to sleep drive with age .
-CONCLUSIONS	Consequences of reduced power in theta and alpha frequencies in older adults remain to be elucidated .
-
-###24722497
-OBJECTIVE	To assess the long-term effects of dietary interventions on glycemic control , need for diabetes medications , and remission of type 2 diabetes .
-METHODS	Originally , in a two-arm trial design , overweight , middle-aged men and women with newly diagnosed type 2 diabetes were randomized to a low-carbohydrate Mediterranean diet ( LCMD ; n = 108 ) or a low-fat diet ( n = 107 ) .
-METHODS	After 4 years , participants who were still free of diabetes medications were further followed up until the primary end point ( need of a diabetic drug ) ; remission of diabetes ( partial or complete ) and changes in weight , glycemic control , and cardiovascular risk factors were also evaluated .
-RESULTS	The primary end point was reached in all participants after a total follow-up of 6.1 years in the low-fat group and 8.1 years in the LCMD group ; median survival time was 2.8 years ( 95 % CI 2.4-3 .2 ) and 4.8 years ( 4.3-5 .2 ) , respectively .
-RESULTS	The unadjusted hazard ratio for the overall follow-up was 0.68 ( 0.50-0 .89 ; P < 0.001 ) .
-RESULTS	LCMD participants were more likely to experience any remission ( partial or complete ) , with a prevalence of 14.7 % ( 13.0-16 .5 % ) during the first year and 5.0 % ( 4.4-5 .6 % ) during year 6 compared with 4.1 % ( 3.1-5 .0 % ) at year 1 and 0 % at year 6 in the low-fat diet group .
-CONCLUSIONS	In patients with newly diagnosed type 2 diabetes , an LCMD resulted in a greater reduction of HbA1c levels , higher rate of diabetes remission , and delayed need for diabetes medication compared with a low-fat diet .
-
-###25313586
-OBJECTIVE	Many sub-Saharan African countries report high postpartum loss to follow-up of mother-baby pairs .
-OBJECTIVE	We aimed to determine whether interactive text messages improved rates of clinic attendance and early infant HIV testing in the Nyanza region of Kenya .
-METHODS	Parallel-group , unblinded , randomized controlled trial .
-METHODS	HIV-positive pregnant women at least 18 years old and enrolled in the prevention of mother-to-child transmission of HIV programme were randomized to receive either text messages ( SMS group , n = 195 ) or usual care ( n = 193 ) .
-METHODS	Messages were developed using formative focus group research informed by constructs of the Health Belief Model .
-METHODS	The SMS group received up to eight text messages before delivery ( depending on gestational age ) , and six messages postpartum .
-METHODS	Primary outcomes included maternal postpartum clinic attendance and virological infant HIV testing by 8 weeks postpartum .
-METHODS	The primary analyses were intention-to-treat .
-RESULTS	Of the 388 enrolled women , 381 ( 98.2 % ) had final outcome information .
-RESULTS	In the SMS group , 38 of 194 ( 19.6 % ) women attended a maternal postpartum clinic compared to 22 of 187 ( 11.8 % ) in the control group ( relative risk 1.66 , 95 % confidence interval 1.02-2 .70 ) .
-RESULTS	HIV testing within 8 weeks was performed in 172 of 187 ( 92.0 % ) infants in the SMS group compared to 154 of 181 ( 85.1 % ) in the control group ( relative risk 1.08 , 95 % confidence interval 1.00-1 .16 ) .
-CONCLUSIONS	Text messaging significantly improved maternal postpartum visit attendance , but overall return rates for these visits remained low .
-CONCLUSIONS	In contrast , high rates of early infant HIV testing were achieved in both arms , with significantly higher testing rates in the SMS compared to the control infants .
-
-###24432673
-OBJECTIVE	To evaluate the clinical effectiveness and safety of Fangfeng Tongsheng Granule ( FTG ) in the treatment of upper respiratory infection ( superficial cold and interior heat syndrome , exterior and interior excess syndrome ) .
-METHODS	A randomized , double-blinded , multi-centered , placebo-parallel-controlled clinical trial was adopted .
-METHODS	Totally 324 patients were enrolled and assigned to two groups , 216 patients in the treatment group and 108 patients in the control group .
-METHODS	Those in the treatment group took FTG at the daily dose of 3 g , twice per day , the therapeutic course being 3 days .
-METHODS	Those with axillary temperature more than 37 degrees C took one more time before medication .
-METHODS	Those in the control group took simulated agent granules the same dose and dosage as the treatment group .
-METHODS	The effect of Chinese medical syndrome ( ECMS ) , the rate of temperature-dropping-to-normal ( RT ) , the time of temperature-dropping-to-normal ( TT ) , the curative effect of single symptom ( CESS ) and adverse reactions were observed .
-RESULTS	Totally 203 completed the trial in the treatment group and 101 in the control group .
-RESULTS	In the treatment group , the cured-effective rate was 55.67 % ( 113 / 101 ) , the total effective rate was 93.10 % ( 189/101 ) , the ECMS score decreased by 9.24 + / - 4.46 , while they were 5.94 % ( 6/101 ) , 36.63 % ( 37/101 ) , and 3.27 + / - 3.29 , respectively in the control group ( P < 0.01 ) .
-RESULTS	The RT was 87.50 % ( 98/112 ) in the treatment group and 58.49 % ( 31/53 ) in the control group ( P < 0.01 ) .
-RESULTS	The TT in the treatment group was superior to that of the control group ( P < 0.01 ) .
-RESULTS	As for CESS , all of the three primary symptoms and nine secondary symptoms were improved more obviously in the treatment group than in the control group .
-RESULTS	The integral decreased obviously , showing statistical difference ( P < 0.01 ) .
-RESULTS	The decrease was more obvious in the treatment group than in the control group ( P < 0.01 ) .
-RESULTS	There was no adverse event related to FTG .
-CONCLUSIONS	FTG was effective and safe in treating upper respiratory infection ( superficial cold and interior heat syndrome , exterior and interior excess syndrome ) .
-
-###25239479
-BACKGROUND	The Modifications of Diet in Renal Disease ( MDRD ) and Chronic Kidney Disease Epidemiology Collaboration ( CKD-EPI ) are 2 equations commonly used to estimate glomerular filtration rate ( eGFR ) .
-BACKGROUND	The predictive performance offered by these equations , particularly in relation to clinical outcomes in elderly hypertensive patients , is not clear .
-METHODS	The Second Australian National Blood Pressure Study cohort was used to investigate the predictive performance of these 2 equations for long-term outcomes ( median 10.8 years ) in elderly treated hypertensive patients .
-METHODS	Both equations were used to calculate eGFR in 6,083 patients aged 65 years and classified as having chronic kidney disease ( CKD ) or no CKD ( eGFR 60ml/min/1 .73 m2 ) .
-RESULTS	More patients were classified as having no CKD using the CKD-EPI equation compared with the MDRD equation ( 72.1 % vs. 69.4 % ; P = 0.001 ) .
-RESULTS	Both equations performed similarly in risk prediction of all-cause and cardiovascular mortality with decreased eGFR , except for patients with baseline eGFR of 45-59ml / min/1 .73 m2 , where the CKD-EPI equation predicted higher risk of all-cause mortality compared with those with no CKD .
-RESULTS	However , the magnitude of difference in risk prediction was too small to be clinically meaningful .
-RESULTS	Both equations showed similar predictive performance .
-RESULTS	However , we observed longer survival and no higher risk in those who were reclassified as having no CKD using the CKD-EPI equation , but these patients were classified earlier as having CKD using the MDRD equation .
-CONCLUSIONS	There was no clinically relevant difference in predictive performance for long-term survival by eGFR calculated using either of these equations in this elderly hypertensive population .
-
-###25405390
-BACKGROUND	Ischemic mitral regurgitation is associated with increased mortality and morbidity .
-BACKGROUND	For surgical patients with moderate regurgitation , the benefits of adding mitral-valve repair to coronary-artery bypass grafting ( CABG ) are uncertain .
-METHODS	We randomly assigned 301 patients with moderate ischemic mitral regurgitation to CABG alone or CABG plus mitral-valve repair ( combined procedure ) .
-METHODS	The primary end point was the left ventricular end-systolic volume index ( LVESVI ) , a measure of left ventricular remodeling , at 1 year .
-METHODS	This end point was assessed with the use of a Wilcoxon rank-sum test in which deaths were categorized as the lowest LVESVI rank .
-RESULTS	At 1 year , the mean LVESVI among surviving patients was 46.122.4 ml per square meter of body-surface area in the CABG-alone group and 49.631.5 ml per square meter in the combined-procedure group ( mean change from baseline , -9.4 and -9.3 ml per square meter , respectively ) .
-RESULTS	The rate of death was 6.7 % in the combined-procedure group and 7.3 % in the CABG-alone group ( hazard ratio with mitral-valve repair , 0.90 ; 95 % confidence interval , 0.38 to 2.12 ; P = 0.81 ) .
-RESULTS	The rank-based assessment of LVESVI at 1 year ( incorporating deaths ) showed no significant between-group difference ( z score , 0.50 ; P = 0.61 ) .
-RESULTS	The addition of mitral-valve repair was associated with a longer bypass time ( P < 0.001 ) , a longer hospital stay after surgery ( P = 0.002 ) , and more neurologic events ( P = 0.03 ) .
-RESULTS	Moderate or severe mitral regurgitation was less common in the combined-procedure group than in the CABG-alone group ( 11.2 % vs. 31.0 % , P < 0.001 ) .
-RESULTS	There were no significant between-group differences in major adverse cardiac or cerebrovascular events , deaths , readmissions , functional status , or quality of life at 1 year .
-CONCLUSIONS	In patients with moderate ischemic mitral regurgitation , the addition of mitral-valve repair to CABG did not result in a higher degree of left ventricular reverse remodeling .
-CONCLUSIONS	Mitral-valve repair was associated with a reduced prevalence of moderate or severe mitral regurgitation but an increased number of untoward events .
-CONCLUSIONS	Thus , at 1 year , this trial did not show a clinically meaningful advantage of adding mitral-valve repair to CABG .
-CONCLUSIONS	Longer-term follow-up may determine whether the lower prevalence of mitral regurgitation translates into a net clinical benefit .
-CONCLUSIONS	( Funded by the National Institutes of Health and the Canadian Institutes of Health Research ; ClinicalTrials.gov number , NCT00806988 . )
-
-###25422247
-OBJECTIVE	To investigate the effects of stellate ganglion block ( SGB ) on the peri-operative vasomotor cytokine content and intrapulmonary shunt in patients with esophagus cancer who underwent thoracotomy .
-METHODS	Forty patients undergoing elective resection of esophageal cancer patients who had I ~ II American Society of Anesthesiologist ( ASA ) were randomly divided into total intravenous anesthesia group ( group N , n = 20 ) and total intravenous anesthesia combined with SGB group ( group S , n = 20 , 0.12 mL/kg 1 % lidocaine was used for SGB 10 min before induction ) .
-METHODS	Heart rate ( HR ) , mean arterial pressure ( MAP ) , central venous pressure ( CVP ) , mean pulmonary arterial pressure ( MPAP ) and continuous cardiac output ( CCO ) were continuously monitored .
-METHODS	The blood from internal jugular vein was drawn respectively before induction ( T0 ) , and 30 min ( T1 ) , 60 min ( T2 ) and 120 min ( T3 ) after one-lung ventilation ( OLV ) , and 30 min ( T4 ) after two-lung ventilation .
-METHODS	The contents of plasma endothelin ( ET ) , nitric oxide ( NO ) and calcitonin gene-related peptide ( CGRP ) were detected with enzyme linked immunosorbent assay ( ELISA ) .
-METHODS	Meanwhile , arterial and mixed venous blood samples were collected for determination of blood gas and calculation of intrapulmonary shunt fraction ( Qs/Qt ) .
-RESULTS	During OLV , ET contents were increased significantly in two groups ( P < 0.05 ) , and no significant difference was presented ( P > 0.05 ) .
-RESULTS	NO content in group S was obviously higher than in group N at T3 ( P < 0.05 ) , whereas CGRP content in group N was markedly lower than in group S at each time point ( P < 0.05 ) .
-RESULTS	Qs/Qt was significantly increased in both groups after OLV , but there was no statistical significant regarding the Qs/Qt at each time point between two groups .
-CONCLUSIONS	Total intravenous anesthesia combined with SGB is conducive to regulation of perioperative vasomotor cytokines in thoracotomy , and has little effect on intrapulmonary shunt at the time of OLV .
-
-###25482145
-BACKGROUND	Lenalidomide plus dexamethasone is a reference treatment for relapsed multiple myeloma .
-BACKGROUND	The combination of the proteasome inhibitor carfilzomib with lenalidomide and dexamethasone has shown efficacy in a phase 1 and 2 study in relapsed multiple myeloma .
-METHODS	We randomly assigned 792 patients with relapsed multiple myeloma to carfilzomib with lenalidomide and dexamethasone ( carfilzomib group ) or lenalidomide and dexamethasone alone ( control group ) .
-METHODS	The primary end point was progression-free survival .
-RESULTS	Progression-free survival was significantly improved with carfilzomib ( median , 26.3 months , vs. 17.6 months in the control group ; hazard ratio for progression or death , 0.69 ; 95 % confidence interval [ CI ] , 0.57 to 0.83 ; P = 0.0001 ) .
-RESULTS	The median overall survival was not reached in either group at the interim analysis .
-RESULTS	The Kaplan-Meier 24-month overall survival rates were 73.3 % and 65.0 % in the carfilzomib and control groups , respectively ( hazard ratio for death , 0.79 ; 95 % CI , 0.63 to 0.99 ; P = 0.04 ) .
-RESULTS	The rates of overall response ( partial response or better ) were 87.1 % and 66.7 % in the carfilzomib and control groups , respectively ( P < 0.001 ; 31.8 % and 9.3 % of patients in the respective groups had a complete response or better ; 14.1 % and 4.3 % had a stringent complete response ) .
-RESULTS	Adverse events of grade 3 or higher were reported in 83.7 % and 80.7 % of patients in the carfilzomib and control groups , respectively ; 15.3 % and 17.7 % of patients discontinued treatment owing to adverse events .
-RESULTS	Patients in the carfilzomib group reported superior health-related quality of life .
-CONCLUSIONS	In patients with relapsed multiple myeloma , the addition of carfilzomib to lenalidomide and dexamethasone resulted in significantly improved progression-free survival at the interim analysis and had a favorable risk-benefit profile .
-CONCLUSIONS	( Funded by Onyx Pharmaceuticals ; ClinicalTrials.gov number , NCT01080391 . )
-
-###25363108
-OBJECTIVE	One of the most important challenges in public health is to improve the quality of life in elders .
-OBJECTIVE	Aging may cause various disorders such as disabilities , high risk conditions and some chronic disease .
-OBJECTIVE	In this study the effect of educational intervention based on precede-proceed on quality of life in elders was examined .
-METHODS	This semi experimental study was carried out on 128 elders over 60 years in Zahedan that were randomly selected by multi-stage sampling method and divided in to control and intervention groups .
-METHODS	Data collection tool was a triploid questionnaire that included demographic data , questions of precede-proceed constructs and SF-36 questionnaire .
-METHODS	The validity and reliability of questionnaire confirmed by experts and Cranach 's Alpha coefficient ( 76 % ) .
-METHODS	After primary data collecting , educational intervention was performed and after nine months data was collected again and analyzed in spss .16 soft-ware using descriptive and analytical statistics .
-RESULTS	The results showed that mean score of quality of life in participants was low and more than 61 % of them had a mean score less than 50 % .
-RESULTS	After intervention the mean score of quality of life only in experimental group significantly increased from 47.72 to 58.90 .
-RESULTS	Behavior and self-rated health were the strongest predictors for quality of life in this study .
-CONCLUSIONS	Implementation educational intervention based on precedes-proceed model can improve quality of life in elders .
-CONCLUSIONS	Elderly women and older elderly individuals compared with elderly men and younger elderly should be considering as an important risk factor for reducing HRQOL .
-
-###24559095
-BACKGROUND	Yes-associated protein ( YAP1 ) is frequently reported to function as an oncogene in many types of cancer , but in breast cancer results remain controversial .
-BACKGROUND	We set out to clarify the role of YAP1 in breast cancer by examining gene and protein expression in subgroups of patient material and by downregulating YAP1 in vitro and studying its role in response to the widely used anti-estrogen tamoxifen .
-METHODS	YAP1 protein intensity was scored as absent , weak , intermediate or strong in two primary breast cancer cohorts ( n = 144 and n = 564 ) and mRNA expression of YAP1 was evaluated in a gene expression dataset ( n = 1107 ) .
-METHODS	Recurrence-free survival was analysed using the log-rank test and Cox multivariate analysis was used to test for independence .
-METHODS	WST-1 assay was employed to measure cell viability and a luciferase ERE ( estrogen responsive element ) construct was used to study the effect of tamoxifen , following downregulation of YAP1 using siRNAs .
-RESULTS	In the ER + ( Estrogen Receptor positive ) subgroup of the randomised cohort , YAP1 expression was inversely correlated to histological grade and proliferation ( p = 0.001 and p = 0.016 , respectively ) whereas in the ER - ( Estrogen Receptor negative ) subgroup YAP1 expression correlated positively to proliferation ( p = 0.005 ) .
-RESULTS	Notably , low YAP1 mRNA was independently associated with decreased recurrence-free survival in the gene expression dataset , specifically for the luminal A subgroup ( p < 0.001 ) which includes low proliferating tumours of lower grade , usually associated with a good prognosis .
-RESULTS	This subgroup specificity led us to hypothesize that YAP1 may be important for response to endocrine therapies , such as tamoxifen , extensively used for luminal A breast cancers .
-RESULTS	In a tamoxifen randomised patient material , absent YAP1 protein expression was associated with impaired tamoxifen response which was significant upon interaction analysis ( p = 0.042 ) .
-RESULTS	YAP1 downregulation resulted in increased progesterone receptor ( PgR ) expression and a delayed and weaker tamoxifen in support of the clinical data .
-CONCLUSIONS	Decreased YAP1 expression is an independent prognostic factor for recurrence in the less aggressive luminal A breast cancer subgroup , likely due to the decreased tamoxifen sensitivity conferred by YAP1 downregulation .
-
-###24996973
-BACKGROUND	Clinical validation of laboratory toothbrushing tests has important advantages .
-BACKGROUND	It was , therefore , the aim to demonstrate correlation of tooth cleaning efficiency of a new robot brushing simulation technique with clinical plaque removal .
-METHODS	Clinical programme : 27 subjects received dental cleaning prior to 3-day-plaque-regrowth-interval .
-METHODS	Plaque was stained , photographically documented and scored using planimetrical index .
-METHODS	Subjects brushed teeth 33-47 with three techniques ( horizontal , rotating , vertical ) , each for 20s buccally and for 20s orally in 3 consecutive intervals .
-METHODS	The force was calibrated , the brushing technique was video supported .
-METHODS	Two different brushes were randomly assigned to the subject .
-METHODS	Robot programme : Clinical brushing programmes were transfered to a 6-axis-robot .
-METHODS	Artificial teeth 33-47 were covered with plaque-simulating substrate .
-METHODS	All brushing techniques were repeated 7 times , results were scored according to clinical planimetry .
-METHODS	All data underwent statistical analysis by t-test , U-test and multivariate analysis .
-RESULTS	The individual clinical cleaning patterns are well reproduced by the robot programmes .
-RESULTS	Differences in plaque removal are statistically significant for the two brushes , reproduced in clinical and robot data .
-RESULTS	Multivariate analysis confirms the higher cleaning efficiency for anterior teeth and for the buccal sites .
-CONCLUSIONS	The robot tooth brushing simulation programme showed good correlation with clinically standardized tooth brushing.This new robot brushing simulation programme can be used for rapid , reproducible laboratory testing of tooth cleaning .
-
-###24401159
-BACKGROUND	Patients surviving stroke but who have significant impairment of function in the affected arm are at more risk of developing pain , stiffness and contractures .
-BACKGROUND	The abnormal muscle activity , associated with post-stroke spasticity , is thought to be causally associated with the development of these complications .
-BACKGROUND	Treatment of spasticity is currently delayed until a patient develops signs of these complications .
-METHODS	This protocol is for a phase II study that aims to identify whether using OnabotulinumtoxinA ( BoNT-A ) in combination with physiotherapy early post stroke when initial abnormal muscle activity is neurophysiologically identified can prevent loss of range at joints and improve functional outcomes.The trial uses a screening phase to identify which people are appropriate to be included in a double blind randomised placebo-controlled trial .
-METHODS	All patients admitted to Sandwell and West Birmingham NHS Trust Hospitals with a diagnosis of stroke will be screened to identify functional activity in the arm .
-METHODS	Those who have no function will be appropriate for further screening .
-METHODS	Patients who are screened and have abnormal muscle activity identified on EMG will be given electrical stimulation to forearm extensors for 3 months and randomised to have either injections of BoNT-A or normal saline .
-METHODS	The primary outcome measure is the action research arm test - a measure of arm function .
-METHODS	Further measures include spasticity , stiffness , muscle strength and fatigue as well as measures of quality of life , participation and caregiver strain .
-BACKGROUND	ISRCTN57435427 , EudraCT2010-021257-39 , NCT01882556 .
-
-###25335326
-OBJECTIVE	To observe the efficacy and safety of Qizhi Jiangtang Capsule ( QJC ) in treating stage 3b diabetic kidney disease ( DKD ) patients with macroalbuminuria .
-METHODS	Patients who conformed to the diagnostic criteria of stage 3b DKD were randomly assigned to two groups according to random digital table , the experiment group and the control group , 84 in each group .
-METHODS	All patients received a two-week elution period , and then were treated with basic Western therapy .
-METHODS	Patients in the experiment group took QJC , 5 pills per time , 3 times a day , while those in the control group took Valsartan Capsule 160 mg each time , once daily .
-METHODS	The observation period of follow-ups was limited within 6 months , and the time points were set as the baseline , 1st month , 3rd month , and 6th month .
-METHODS	Systolic blood pressure ( SBP ) , diastolic blood pressure ( DBS ) , 24 h urine protein quantitative ( 24 h UPQ ) , plasma albumin ( ALB ) , and serum creatinine ( SCr ) were detected and recorded , and estimated glomerular filtration rate ( eGFR ) was calculated .
-METHODS	The occurrence of hypoglycemic reaction , coagulation disorder , gastrointestinal tract reaction , allergy , hyperkalemia , doubling of creatinine , and overall adverse events were observed and recorded at same time .
-RESULTS	Finally 81 patients in the experiment group and 80 patients in the control group were effectively included .
-RESULTS	Compared with the baseline level , SBP and DBS obviously decreased in the control group at month 1 of treatment ( P < 0.05 ) , and more significantly decreased at month 6 of treatment ( P < 0.01 ) .
-RESULTS	SBP at month 1 , 3 , and 6 of follow-ups ; DBS at month 6 of follow-ups was lower in the control group than in the experiment group ( P < 0.05 ) .
-RESULTS	At month 1 , 3 , and 6 of follow-ups , 24 h UPQ of the experiment group was significantly lower than the baseline level ( P < 0.01 ) .
-RESULTS	It was also significantly lower than the level of the control group at the same time point ( P < 0.05 ) .
-RESULTS	There was no significant difference in 24 h UPQ at month 1 , 3 , and 6 of follow-ups between the control group and the baseline level ( P > 0.05 ) .
-RESULTS	ALB of the experiment group showed an increasing trend .
-RESULTS	It was significantly higher than the baseline level at month 6 ( P < 0.05 ) , which was also higher than that of the control group at same period ( P < 0.05 ) .
-RESULTS	There was no significant difference in the ALB level in the control group ( P > 0.05 ) .
-RESULTS	SCr of two groups showed an increasing trend .
-RESULTS	SCr of the experiment group was significantly higher at month 1 , 3 , and 6 follow-ups than the baseline level ( P < 0.05 ) .
-RESULTS	But the increment of SCr was higher in the control group than in the experimental group , and obviously higher than the baseline levels ( P < 0.05 ) .
-RESULTS	eGFR of both groups showed a decreasing trend .
-RESULTS	The decrement was higher in the control group than in the experimental group ( P < 0.05 ) .
-RESULTS	The proportion of progression of renal functions at month 1 , 3 , and 6 of follow-ups in the experimental group was 0.0 % ( 0 case ) , 9.55 % ( 8 cases ) , and 21.4 % ( 18 cases ) , while they were 8.3 % ( 7 cases ) , 21.4 % ( 18 cases ) , and 40.5 % ( 34 cases ) in the control group .
-RESULTS	There was no statistical difference in the proportion of progression of renal functions between the two groups at month 3 and 6 of follow-ups ( P < 0.05 ) .
-RESULTS	There was no statistical difference in the incidence of adverse reactions between two groups ( P > 0.05 ) .
-CONCLUSIONS	QJC could effectively reduce urinary protein of patients with stage 3b DKD , and delay the progression of renal functions .
-
-###24687430
-OBJECTIVE	To investigate and compare several quantification methods of myocardial perfusion measurements , paying special attention to the relation between the techniques and the required measurement duration .
-METHODS	Seven patients underwent contrast-enhanced rest and stress cardiac perfusion measurements at 3T .
-METHODS	Three slices were acquired in each patient and were divided into 16 segments , leading to 112 rest and stress data curves , which were analyzed using various tracer kinetic models as well as a model-free deconvolution .
-METHODS	Plasma flow , plasma volume , and myocardial perfusion reserve were analyzed for the complete acquisition as well as for the first pass data only .
-RESULTS	Deconvolution analysis yielded stable results for both rest and stress analysis , while Fermi and one compartment models agree well for first pass data ( rest measurements only ) and prolonged data acquisition ( stress measurements only ) .
-RESULTS	More complex models do not yield satisfactory results for the short measurement times investigated in this study .
-CONCLUSIONS	When performing MRI-based quantification of myocardial perfusion , care must be taken that the method used is appropriate for the time frame under investigation .
-CONCLUSIONS	When a numerical deconvolution is used instead of tracer kinetic models , more stable results are obtained .
-
-###24399554
-OBJECTIVE	Combining pharmacotherapies for tobacco-dependence treatment may increase smoking abstinence .
-OBJECTIVE	To determine efficacy and safety of varenicline and bupropion sustained-release ( SR ; combination therapy ) compared with varenicline ( monotherapy ) in cigarette smokers .
-METHODS	Randomized , blinded , placebo-controlled multicenter clinical trial with a 12-week treatment period and follow-up through week 52 conducted between October 2009 and April 2013 at 3 midwestern clinical research sites .
-METHODS	Five hundred six adult ( 18 years ) cigarette smokers were randomly assigned and 315 ( 62 % ) completed the study .
-METHODS	Twelve weeks of varenicline and bupropion SR or varenicline and placebo .
-METHODS	Primary outcome was abstinence rates at week 12 , defined as prolonged ( no smoking from 2 weeks after the target quit date ) abstinence and 7-day point-prevalence ( no smoking past 7 days ) abstinence .
-METHODS	Secondary outcomes were prolonged and point-prevalence smoking abstinence rates at weeks 26 and 52 .
-METHODS	Outcomes were biochemically confirmed .
-RESULTS	At 12 weeks , 53.0 % of the combination therapy group achieved prolonged smoking abstinence and 56.2 % achieved 7-day point-prevalence smoking abstinence compared with 43.2 % and 48.6 % in varenicline monotherapy ( odds ratio [ OR ] , 1.49 ; 95 % CI , 1.05-2 .12 ; P = .03 and OR , 1.36 ; 95 % CI , 0.95-1 .93 ; P = .09 , respectively ) .
-RESULTS	At 26 weeks , 36.6 % of the combination therapy group achieved prolonged and 38.2 % achieved 7-day point-prevalence smoking abstinence compared with 27.6 % and 31.9 % in varenicline monotherapy ( OR , 1.52 ; 95 % CI , 1.04-2 .22 ; P = .03 and OR , 1.32 ; 95 % CI , 0.91-1 .91 ; P = .14 , respectively ) .
-RESULTS	At 52 weeks , 30.9 % of the combination therapy group achieved prolonged and 36.6 % achieved 7-day point-prevalence smoking abstinence compared with 24.5 % and 29.2 % in varenicline monotherapy ( OR , 1.39 ; 95 % CI , 0.93-2 .07 ; P = .11 and OR , 1.40 ; 95 % CI , 0.96-2 .05 ; P = .08 , respectively ) .
-RESULTS	Participants receiving combination therapy reported more anxiety ( 7.2 % vs 3.1 % ; P = .04 ) and depressive symptoms ( 3.6 % vs 0.8 % ; P = .03 ) .
-CONCLUSIONS	Among cigarette smokers , combined use of varenicline and bupropion , compared with varenicline alone , increased prolonged abstinence but not 7-day point prevalence at 12 and 26 weeks .
-CONCLUSIONS	Neither outcome was significantly different at 52 weeks .
-CONCLUSIONS	Further research is required to determine the role of combination therapy in smoking cessation .
-BACKGROUND	clinicaltrials.gov Identifier : http://clinicaltrials.gov/show/NCT00935818 .
-
-###24684734
-OBJECTIVE	To study the efficacy of transdermal clonidine in the treatment of severe refractory hyperemesis gravidarum ( HG ) , the most severe illness of pregnancy .
-METHODS	The study had a randomised , double - blind , placebo-controlled , cross-over design ( RCT ) .
-METHODS	Single tertiary referral hospital after admission of patients .
-METHODS	Twelve women of gestational age 6-12 weeks and a major grade of HG clinical severity who were unresponsive to standard antiemetic treatment .
-METHODS	The patients were randomly treated with and without the active drug ( 5 mg patch ) for two consecutive periods of 5 days .
-METHODS	The patients were allocated to a random list to receive first placebo and then active drug or the other way round .
-METHODS	Other antiemetic drugs were administered on a scheduled or as-needed basis .
-METHODS	All patients received intravenous hydration and thiamine supplementation .
-METHODS	Pregnancy Unique Quantification of Emesis ( PUQE ) and visual analog scale ( VAS ) clinical scores , positive morning urine ketonuria , number of doses of standard antiemetic drugs required , and number of days off intravenous therapy were compared in the two periods .
-RESULTS	Transdermal clonidine led to a significantly greater improvement compared with placebo of the primary ( PUQE score P = 0.026 CI 0.43-3 .24 ; VAS score P = 0.010 CI 2.17-12 .83 ) and secondary outcome measures .
-RESULTS	A reduction of blood pressure was reported for systolic 6 mmHg P = 0.01 and diastolic 3 mmHg P = 0.055 .
-CONCLUSIONS	This preliminary RCT demonstrates the efficacy of transdermal clonidine in the treatment of severe HG , leading to a significant reduction of symptoms and reducing the need for other supportive measures and medications .
-
-###24720885
-BACKGROUND	Maternal obesity and gestational diabetes mellitus ( GDM ) may independently influence offspring fat mass and metabolic disease susceptibility .
-BACKGROUND	In this pilot study , body composition and fat distribution in offspring from obese women with and without GDM and lean women were assessed within the 1st year of life , and maternal and newborn plasma factors were related to offspring adipose tissue distribution .
-METHODS	Serum and plasma samples from pregnant obese women with ( n = 16 ) or without ( n = 13 ) GDM and normoglycemic lean women ( n = 15 ) at 3rd trimester and offspring cord plasma were used for analyzing lipid profiles , insulin and adipokine levels .
-METHODS	At week-1 and 6 , month-4 and year-1 , offspring anthropometrics and skinfold thickness ( SFT ) were measured and abdominal subcutaneous ( SCA ) and preperitoneal adipose tissue ( PPA ) were determined by ultrasonography .
-RESULTS	Cord insulin was significantly increased in the GDM group , whereas levels of cord leptin , total and high molecular weight ( HMW ) adiponectin were similar between the groups .
-RESULTS	Neonates of the GDM group showed significantly higher SFT and fat mass until week-6 and significantly increased SCA at week-1 compared to the lean group that persisted as strong trend at week-6 .
-RESULTS	Interestingly , PPA in neonates of the GDM group was significantly elevated at week-1 compared to both the lean and obese group .
-RESULTS	At month-4 and year-1 , significant differences in adipose tissue growth between the groups were not observed .
-RESULTS	Multiple linear regression analyses revealed that cord insulin levels are independently related to neonatal PPA that showed significant relation to PPA development at year-1 .
-RESULTS	Maternal fasted C-peptide and HMW adiponectin levels at 3rd trimester emerged to be determinants for PPA at week-1 .
-CONCLUSIONS	Maternal pregravid obesity combined with GDM leads to newborn hyperinsulinemia and increased offspring fat mass until week-6 , whereas pregravid obesity without GDM does not .
-CONCLUSIONS	This strongly suggests the pivotal role of GDM in the adverse offspring outcome .
-CONCLUSIONS	Maternal C-peptide and HMW adiponectin levels in pregnancy emerge to be predictive for elevated PPA in newborns and might be indicative for the obesity risk at later life .
-CONCLUSIONS	Altogether , the findings from our pilot study warrant evaluation in long-term studies .
-BACKGROUND	German Clinical Trials Register DRKS00004370 .
-
-###25399274
-OBJECTIVE	While effective in preventing stroke in patients with atrial fibrillation ( AF ) , warfarin is limited by a narrow therapeutic profile , a need for lifelong coagulation monitoring , and multiple drug and diet interactions .
-OBJECTIVE	To determine whether a local strategy of mechanical left atrial appendage ( LAA ) closure was noninferior to warfarin .
-METHODS	PROTECT AF was a multicenter , randomized ( 2:1 ) , unblinded , Bayesian-designed study conducted at 59 hospitals of 707 patients with nonvalvular AF and at least 1 additional stroke risk factor ( CHADS2 score 1 ) .
-METHODS	Enrollment occurred between February 2005 and June 2008 and included 4-year follow-up through October 2012 .
-METHODS	Noninferiority required a posterior probability greater than 97.5 % and superiority a probability of 95 % or greater ; the noninferiority margin was a rate ratio of 2.0 comparing event rates between treatment groups .
-METHODS	Left atrial appendage closure with the device ( n = 463 ) or warfarin ( n = 244 ; target international normalized ratio , 2-3 ) .
-METHODS	A composite efficacy end point including stroke , systemic embolism , and cardiovascular/unexplained death , analyzed by intention-to-treat .
-RESULTS	At a mean ( SD ) follow-up of 3.8 ( 1.7 ) years ( 2621 patient-years ) , there were 39 events among 463 patients ( 8.4 % ) in the device group for a primary event rate of 2.3 events per 100 patient-years , compared with 34 events among 244 patients ( 13.9 % ) for a primary event rate of 3.8 events per 100 patient-years with warfarin ( rate ratio , 0.60 ; 95 % credible interval , 0.41-1 .05 ) , meeting prespecified criteria for both noninferiority ( posterior probability , > 99.9 % ) and superiority ( posterior probability , 96.0 % ) .
-RESULTS	Patients in the device group demonstrated lower rates of both cardiovascular mortality ( 1.0 events per 100 patient-years for the device group [ 17/463 patients , 3.7 % ] vs 2.4 events per 100 patient-years with warfarin [ 22/244 patients , 9.0 % ] ; hazard ratio [ HR ] , 0.40 ; 95 % CI , 0.21-0 .75 ; P = .005 ) and all-cause mortality ( 3.2 events per 100 patient-years for the device group [ 57/466 patients , 12.3 % ] vs 4.8 events per 100 patient-years with warfarin [ 44/244 patients , 18.0 % ] ; HR , 0.66 ; 95 % CI , 0.45-0 .98 ; P = .04 ) .
-CONCLUSIONS	After 3.8 years of follow-up among patients with nonvalvular AF at elevated risk for stroke , percutaneous LAA closure met criteria for both noninferiority and superiority , compared with warfarin , for preventing the combined outcome of stroke , systemic embolism , and cardiovascular death , as well as superiority for cardiovascular and all-cause mortality .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00129545 .
-
-###25758270
-BACKGROUND	Despite great reduction of in-stent restenosis , first-generation drug-eluting stents ( DESs ) have increased the risk of late stent thrombosis due to delayed endothelialization .
-BACKGROUND	Arsenic trioxide , a natural substance that could inhibit cell proliferation and induce cell apoptosis , seems to be a promising surrogate of sirolimus to improve DES performance .
-BACKGROUND	This randomized controlled trial was to evaluate the efficacy and safety of a novel arsenic trioxide-eluting stent ( AES ) , compared with traditional sirolimus-eluting stent ( SES ) .
-METHODS	Patients with symptoms of angina pectoris were enrolled and randomized to AES or SES group .
-METHODS	The primary endpoint was target vessel failure ( TVF ) , and the second endpoint includes rates of all-cause death , cardiac death or myocardial infarction , target lesion revascularization ( TLR ) by telephone visit and late luminal loss ( LLL ) at 9-month by angiographic follow-up .
-RESULTS	From July 2007 to 2009 , 212 patients were enrolled and randomized 1:1 to receive either AES or SES .
-RESULTS	At 2 years of follow-up , TVF rate was similar between AES and SES group ( 6.67 % vs. 5.83 % , P = 0.980 ) .
-RESULTS	Frequency of all-cause death was significantly lower in AES group ( 0 vs. 4.85 % , P = 0.028 ) .
-RESULTS	There was no significant difference between AES and SES in frequency of TLR and in-stent restenosis , but greater in-stent LLL was observed for AES group ( 0.29 0.52 mm vs. 0.10 0.25 mm , P = 0.008 ) .
-CONCLUSIONS	After 2 years of follow-up , AES demonstrated comparable efficacy and safety to SES for the treatment of de novo coronary artery lesions .
-
-###24608069
-BACKGROUND	Raltegravir is an HIV-1 integrase inhibitor approved for use in adults , children and infants 4 weeks of age .
-BACKGROUND	As alternatives to the original film-coated tablet , a chewable ethylcellulose ( EC ) tablet and oral granules for suspension ( GFS ) have been developed for use in children .
-BACKGROUND	The purpose of this study was to evaluate these formulations in adults prior to use in paediatric studies .
-METHODS	This open-label , 4-period , randomized , crossover study investigated the safety , tolerability and pharmacokinetics of raltegravir paediatric formulations and the effect of a high-fat meal on EC tablet pharmacokinetics in healthy adults .
-METHODS	In a balanced , crossover design ( with a 4-day washout between treatments ) , 12 subjects received one 400 mg film-coated tablet ( fasted ) , four 100 mg EC tablets ( fasted ) , one 400 mg GFS dose ( fasted ) and four 100 mg EC tablets ( after a high-fat meal ) .
-RESULTS	AUC0 - and Cmax were 2.6-fold and 4.6-fold higher for GFS and 1.8-fold and 3.2-fold higher for EC versus film-coated tablets .
-RESULTS	The geometric mean C12h values for the GFS formulation ( 162 nM ) and the EC tablet ( 134 nM ) were similar to that of the film-coated tablet ( 149 nM ) .
-RESULTS	Administration with a high-fat meal increased C12h , decreased Cmax and delayed Tmax for the EC tablet , but did not affect AUC0 - .
-RESULTS	There were no serious adverse events ( AEs ) and no discontinuations due to drug-related clinical or laboratory AEs .
-CONCLUSIONS	Both paediatric formulations demonstrate moderately higher AUC0 - and Cmax , and similar C12h compared with the film-coated tablet .
-CONCLUSIONS	These data support the use of raltegravir GFS and EC formulations in paediatric studies .
-
-###24840756
-OBJECTIVE	To determine the effect of neonatal caffeine treatment on rates of developmental coordination disorder ( DCD ) .
-METHODS	Children in the Caffeine for Apnea of Prematurity trial were assessed for motor performance ( Movement Assessment Battery for Children [ MABC ] ) , clinical signs of cerebral palsy , and Full-Scale IQ at 5 years of age by staff who were unaware of the children 's treatment group .
-METHODS	DCD was defined as MABC < 5th percentile in children with a Full-Scale IQ > 69 who did not have a diagnosis of cerebral palsy .
-RESULTS	There were 1433 children with known MABC corrected-age percentile as well as known Full-Scale IQ at 5 years and cerebral palsy status , of whom 735 had been randomly assigned to caffeine and 698 to placebo therapy .
-RESULTS	The rate of DCD was lower in those treated with caffeine ( 11.3 % ) than in the placebo group ( 15.2 % ) ( OR adjusted for center and baseline covariates , 0.71 , 95 % CI , 0.52-0 .97 ; P = .032 ) .
-CONCLUSIONS	Neonatal caffeine therapy for apnea of prematurity reduces the rate of DCD at 5 years of age .
-CONCLUSIONS	As more children have DCD than have cerebral palsy , this is an important additional benefit from neonatal caffeine treatment .
-
-###25845088
-OBJECTIVE	To determine whether exercise training might exert anti-inflammatory effect by reducing HMGB1 levels in women with breast cancer ( BC ) .
-METHODS	We analyzed monocentric data from the DIANA ( DIET AND ANDROGENS ) -5 PROJECT .
-METHODS	Study population consisted of 94 patients randomized into two groups : 61 patients ( 53 + / - 8 yrs , training group ) were assigned to a structured exercise training intervention ( 3 times/week for the first 3 months , and once / week for the following 9 months ) ; whereas 33 patients ( 52 + / - 7 yrs , control group ) followed only the general indications to adhere to the life-style intervention suggestions of the DIANA protocol .
-METHODS	At study entry and after 12 months , all patients underwent cardiopulmonary exercise testing , biochemical as - sessment [ HMGB1 , high-sensitivity C-reactive protein ( hs-CRP ) , interleukin-6 ( IL-6 ) ] ; and lipid and glycemic profile .
-RESULTS	There were no significant differences between groups in baseline clinical and inflammatory profile .
-RESULTS	Among the training group , only 19/61 patients had high adherence to the exercise intervention .
-RESULTS	After stratifying the study population according to the level of adhesion to the exer - cise intervention , 1-year HMGB1 levels were lower among patients more adherent to exercise ( p for trend = 0.001 ) .
-RESULTS	Further adjusting for age , body mass index and baseline values , 1-year HMGB1 levels remained significantly and inversely associated to the level of adhesion to the exercise intervention ( B = -0.97 , SE = 0.43 , p = 0.01 ) .
-CONCLUSIONS	Moderate intensity exercise training in BC survivors is associated with reduced HMGB1 levels that are proportional to the level of adhesion to the exercise intervention , independently from other classical inflammatory molecules , suggesting an exercise-induced anti-inflammatory effect mediated by HMGB1 .
-
-###25010236
-BACKGROUND	According to the literature , 40 % of injuries affecting school-age children are sports related .
-BACKGROUND	The role of physical education students , as future teachers , seems to be of high importance in terms of protecting children 's safety during sports classes .
-OBJECTIVE	The aim is to evaluate the level of basic life support ( BLS ) knowledge and skills in physical education students instructed with the use of different methods .
-METHODS	Second-year physical education students ( n = 104 , M age = 200.6 years ) were randomly assigned to three groups : experimental 1 ( E1 ) , experimental 2 ( E2 ) , and control ( C ) .
-METHODS	Group E1 students participated in a 2-hour BLS course based on computer-assisted presentations .
-METHODS	Group E2 trainees practiced BLS algorithm in pairs during a 2-hour course .
-METHODS	No manikins were used in both intervention groups .
-METHODS	Students of Group C were asked to learn BLS algorithm on their own .
-METHODS	All groups fulfilled a 10-question multiple-choice test on BLS at the beginning and the end of the experiment .
-METHODS	After completing the course participants performed BLS on a manikin .
-RESULTS	The results of knowledge test were not significant before an experiment but differed essentially among the groups afterward ( analysis of variance contrast analysis , p < .05 ) .
-RESULTS	Regardless of teaching method used , no significant differences were found among the students in preparatory BLS actions and cardiopulmonary resuscitation ( CPR ) performance on a manikin .
-RESULTS	The level of CPR performance was very low in all groups .
-CONCLUSIONS	Students of both intervention groups improved their BLS knowledge after the training .
-CONCLUSIONS	Teaching methods used in the current study seemed to be ineffective in terms of practical CPR skills .
-CONCLUSIONS	Access to greater number of modern manikins should improve the BLS training in physical education students .
-CONCLUSIONS	Moreover , permanent consultation on instructional methods with emergency medicine experts is recommended for university teachers .
-
-###24621834
-BACKGROUND	This study evaluated the efficacy and safety of levosimendan , a positive inotropic drug with vasodilator effects , given intravenously to patients with acutely decompensated heart failure ( ADHF ) .
-METHODS	We performed 2 sequential trials , the first to develop a new measure of efficacy in 100 patients , and the second to use this measure to evaluate levosimendan in an additional 600 patients .
-METHODS	Patients admitted with ADHF received placebo or intravenous levosimendan for 24 h in addition to standard treatment .
-METHODS	The primary endpoint was a composite that evaluated changes in clinical status during the first 5 days after randomization .
-RESULTS	In the 600-patient trial , more levosimendan than placebo patients ( 58 vs. 44 ) were improved at all 3 pre-specified time points ( 6 h , 24 h , and 5 days ) , whereas fewer levosimendan patients ( 58 vs. 82 ) experienced clinical worsening ( p = 0.015 for the difference between the groups ) .
-RESULTS	These differences were apparent , despite more frequent intensification of adjunctive therapy in the placebo group ( 79 vs. 45 patients ) .
-RESULTS	Improvements in patient self-assessment and declines in B-type natriuretic peptide levels with levosimendan persisted for 5 days and were associated with reduced length of stay ( p = 0.009 ) .
-RESULTS	Similar findings were present in the 100-patient pilot trial .
-RESULTS	Levosimendan was associated with more frequent hypotension and cardiac arrhythmias during the infusion period and a numerically higher risk of death across the 2 trials ( 49 of 350 on a regimen of levosimendan vs. 40 of 350 on a regimen of placebo at 90 days , p = 0.29 ) .
-CONCLUSIONS	In patients with ADHF , intravenous levosimendan provided rapid and durable symptomatic relief .
-CONCLUSIONS	As dosed in this trial , levosimendan was associated with an increased risk of adverse cardiovascular events .
-CONCLUSIONS	( Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure ; NCT00048425 ) .
-
-###25171502
-OBJECTIVE	To compare the treatment outcome of tamsulosin 0.4 mg ( TAM ) with or without solifenacin 5 mg ( SOL ) for the most bothersome symptom in male lower urinary tract symptoms ( LUTS ) with overactive bladder ( OAB ) .
-METHODS	Male LUTS/OAB ( 50 years ) patients who had a total International Prostate Symptom Score ( I-PSS ) of 12 , I-PSS urgency-related question of 2 , and quality of life ( QoL ) of 3 points were enrolled .
-METHODS	Patients who complained of storage symptoms as the most bothersome were included in the ` storage ' group .
-METHODS	Patients who complained of voiding symptoms as the most bothersome were included in the ` voiding ' group .
-METHODS	The change in the I-PSS was compared between the two groups 4 weeks after commencing treatment .
-RESULTS	In the storage group , 172 were able to finish this study ( TAM : 88 , TAM + SOL : 84 ) .
-RESULTS	The improvement of I-PSS and QoL with TAM + SOL was significantly greater than with TAM alone ( p < 0.001 ) .
-RESULTS	In the voiding group , 108 were able to finish the study ( TAM : 54 , TAM + SOL : 54 ) .
-RESULTS	The improvement of I-PSS and QoL with TAM alone was significantly greater than with TAM + SOL ( p < 0.001 ) .
-CONCLUSIONS	The most bothersome symptom in male LUTS/OAB should be considered when choosing the appropriate medical treatment .
-
-###25384338
-BACKGROUND	Multiple phase-2 trials in men with biochemically-recurrent prostate cancer ( BRPC ) have assessed the impact of nonhormonal agents on PSA kinetics .
-BACKGROUND	We have previously demonstrated that changes in PSA kinetics correlate with metastasis-free survival ; however , it is unknown whether these changes also correlate with overall survival ( OS ) .
-METHODS	We performed a combined retrospective analysis of 146 men with BRPC treated on phase-2 trials using one of four investigational drugs : lenalidomide ( n = 60 ) , marimastat ( n = 39 ) , ATN-224 ( n = 22 ) and imatinib ( n = 25 ) .
-METHODS	We examined factors influencing OS , including within-subject changes in PSA kinetics ( PSA slope , PSA doubling time and PSA velocity ) , before and 6 months after treatment initiation .
-RESULTS	After a median follow-up of 83.1 months , 49 of 146 men had died .
-RESULTS	In univariate Cox regression analysis , two factors were associated with OS : baseline PSA velocity and change in PSA velocity on therapy .
-RESULTS	In a landmark multivariable model , stratified by study ( which controlled for age , Gleason score , type of local therapy and use of androgen-deprivation therapy prior to metastases ) , baseline PSA velocity and increase in PSA velocity on therapy remained independent predictors of OS .
-RESULTS	Median OS for men with an increase in PSA velocity on treatment was 115.4 months and was not reached for men with a decrease in PSA velocity ( hazard ratio = 0.47 , 95 % confidence interval 0.25-0 .88 ; P = 0.02 ) .
-CONCLUSIONS	This hypothesis-generating study suggests that within-subject changes in PSA velocity after initiation of nonhormonal therapy may correlate with OS in men with BRPC .
-CONCLUSIONS	If validated in prospective trials , change in PSA velocity may represent a reasonable intermediate end point for screening new agents in these patients .
-
-###24882460
-OBJECTIVE	The aims of the present study were to evaluate the efficacy of and compliance with a new device for autoinflation in the treatment of persistent otitis media with effusion ( OME ) in young children .
-METHODS	Forty-five children with persistent OME with a bilateral type B or C2 tympanogram for at least three months and history of subjective hearing loss , waiting for grommet surgery , were randomised to a treatment and a control group .
-METHODS	Twenty-three children aged between three and eight years started as the treatment group with the new device for autoinflation .
-METHODS	Another 22 children , aged between two and eight years were included as controls .
-METHODS	After a period of four weeks , a cross-over was performed .
-METHODS	Both groups underwent otomicroscopy , tympanometry and audiometry at inclusion and after one and two months for the evaluation of treatment efficiency .
-METHODS	The primary outcome measurements were improvement in middle-ear pressure and hearing thresholds at eight weeks .
-METHODS	Both groups were then followed up for another 10 months .
-RESULTS	In the treatment group , the mean middle-ear pressure for both ears and the mean hearing thresholds for the best ear improved by 166 daPa ( p < 0.0001 ) and 6 dB ( p < 0.0001 ) , respectively after four weeks , while in the control group , non-significant alterations were observed .
-RESULTS	After the cross-over of the control group to treatment , equivalent improvements in the mean middle-ear pressure and the mean hearing thresholds of 187 daPa ( p < 0.0001 ) and 7 dB ( p < 0.01 ) , respectively were achieved also in this group .
-RESULTS	After treatment in both groups at eight weeks , four of 45 children were submitted to grommet surgery .
-RESULTS	During the long-term follow-up another five children were submitted to surgery due to recurrence of disease .
-RESULTS	All the children managed to perform the manoeuvre and no side-effects were detected .
-CONCLUSIONS	The device demonstrated efficiency in improving both middle-ear pressure and hearing thresholds in most children after four weeks of treatment .
-CONCLUSIONS	It might therefore be possible to consider this method of autoinflation in children with persistent OME during the watchful waiting period .
-
-###24291151
-BACKGROUND	The negative consequences of unhealthy weight gain and the high likelihood of pediatric obesity tracking into adulthood highlight the importance of targeting youth who are ` at risk ' of obesity .
-BACKGROUND	The aim of this paper is to report the rationale and study protocol for the ` Active Teen Leaders Avoiding Screen-time ' ( ATLAS ) obesity prevention intervention for adolescent boys living in low-income communities .
-METHODS	The ATLAS intervention will be evaluated using a cluster randomized controlled trial in 14 secondary schools in the state of New South Wales ( NSW ) , Australia ( 2012 to 2014 ) .
-METHODS	ATLAS is an 8-month multi-component , school-based program informed by self-determination theory and social cognitive theory .
-METHODS	The intervention consists of teacher professional development , enhanced school-sport sessions , researcher-led seminars , lunch-time physical activity mentoring sessions , pedometers for self-monitoring , provision of equipment to schools , parental newsletters , and a smartphone application and website .
-METHODS	Assessments were conducted at baseline and will be completed again at 9 - and 18-months from baseline .
-METHODS	Primary outcomes are body mass index ( BMI ) and waist circumference .
-METHODS	Secondary outcomes include BMI z-scores , body fat ( bioelectrical impedance analysis ) , physical activity ( accelerometers ) , muscular fitness ( grip strength and push-ups ) , screen-time , sugar-sweetened beverage consumption , resistance training skill competency , daytime sleepiness , subjective well-being , physical self-perception , pathological video gaming , and aggression .
-METHODS	Hypothesized mediators of behavior change will also be explored .
-CONCLUSIONS	ATLAS is an innovative school-based intervention designed to improve the health behaviors and related outcomes of adolescent males in low-income communities .
-
-###24682081
-OBJECTIVE	Our recent work indicates that endogenous opioid activity influences analgesic responses to opioid medications .
-OBJECTIVE	This secondary analysis evaluated whether endogenous opioid activity is associated with degree of opioid analgesic adverse effects , and whether chronic pain status and sex affect these adverse effects .
-METHODS	Using a double-blind , randomized , placebo-controlled , crossover design , 51 subjects with chronic low back pain and 38 healthy controls participated in 3 separate sessions , undergoing 2 laboratory-evoked pain tasks ( ischemic and thermal ) after receiving placebo , naloxone , or morphine .
-METHODS	Endogenous opioid system function was indexed by the difference in pain responses between the placebo and naloxone conditions .
-METHODS	These measures were examined for associations with morphine-related adverse effects .
-RESULTS	Chronic pain subjects reported significantly greater itching and unpleasant bodily sensations with morphine than controls ( P < 0.05 ) .
-RESULTS	Across groups , only 6 of 112 possible associations between adverse effects and blockade effects were significant .
-RESULTS	For the ischemic task , higher endogenous opioid function was associated with greater itching ( visual analog scale [ VAS ] ; P < 0.05 ) , numbness ( tolerance ; P < 0.001 ) , dry mouth ( tolerance ; P < 0.05 ) , and unpleasant bodily sensations ( VAS ; P < 0.05 ) .
-RESULTS	For the thermal task , higher endogenous opioid function was associated with greater numbness ( VAS ; P < 0.05 ) and feeling carefree ( VAS ; P < 0.05 ) .
-RESULTS	There were no significant main or interaction effects of chronic pain status or sex on these findings .
-CONCLUSIONS	No consistent relationships were observed between endogenous opioid function and morphine-related adverse effects .
-CONCLUSIONS	This is in stark contrast to our previous observation of strong relationships between elevated endogenous opioid function and smaller morphine analgesic effects .
-
-###25098612
-OBJECTIVE	A new core biopsy needle for endoscopic ultrasound ( EUS ) - guided sampling has recently been developed .
-OBJECTIVE	The aim of this prospective multicenter study was to compare this needle with a standard needle in patients with solid pancreatic masses .
-METHODS	Consecutive patients with solid pancreatic masses referred to 17 centers for EUS-guided sampling were included .
-METHODS	Each patient had two passes with a standard 22G needle and a single pass with a 22G core needle performed in a randomized order .
-METHODS	Samples from both needles were separately processed for liquid-based cytology and cell-block preparation and were assessed independently by two blinded expert pathologists .
-METHODS	The primary endpoint was the accuracy of the detection of malignancy .
-METHODS	The reference standard was based on further cytohistological analysis obtained under ultrasound or computed tomography scanning , endoscopic or surgical guidance , and/or by clinical follow-up with repeated imaging examinations for at least 12 months .
-METHODS	The secondary endpoints were the rate of technical failure and the quality of the cytohistological samples obtained .
-RESULTS	Of the 80 patients included ( 49 men ; mean age 67.111.1 ) , 87.5 % had final malignant diagnoses ( adenocarcinoma n = 62 , 77.5 % ) .
-RESULTS	There was no difference between the needles in diagnostic accuracy ( standard needle 92.5 % vs. core needle 90 % ; P = 0.68 ) or technical failure .
-RESULTS	Both pathologists found the overall sample quality significantly better for the standard needle ( expert 1 , P = 0.009 ; expert 2 , P = 0.002 ) .
-CONCLUSIONS	The diagnostic accuracy of EUS sampling for solid pancreatic masses using standard and core needles seems comparable but with a better overall histological sample quality for the former .
-CONCLUSIONS	ClinicalTrial.gov identifier : NCT01479803 .
-
-###24717698
-OBJECTIVE	The purpose of this study was to evaluate the safety and efficacy of three different intravenous ( IV ) doses of palonosetron compared with placebo for the prevention of postoperative nausea and vomiting ( PONV ) in children undergoing dental rehabilitation under general anesthesia ( DRGA ) in the first 24 hours after discharge .
-METHODS	A total of 286 children who were classified with an American Society of Anesthesiologists physical status of I and II , between three and 13 years old ( mean = 6.13 years old ) , and undergoing DRGA were enrolled in this study .
-METHODS	The children were randomized to receive one of the three doses of palonosetron ( 0.0025 mg , 0.0050 mg , or 0.0075 mg ) or placebo immediately before induction of anesthesia .
-RESULTS	Compared with placebo , the incidence of PONV was significantly lower in the palonosetron groups ( P < .05 ) .
-RESULTS	However , there were no statistically significant differences among the palonosetron groups regarding the number of children with PONV during all time periods after anesthesia ( P < .05 ) .
-CONCLUSIONS	A single 0.0025 mg intravenous dose of palonosetron is recommended for further evaluation , as it appears to be an effective dose for prevention of postoperative nausea and vomiting in children undergoing dental rehabilitation under general anesthesia .
-
-###25256813
-OBJECTIVE	To assess bacillus Calmette-Gurin maintenance treatment schedule for non-muscle invasive bladder cancer at 2 years , using one-third of the full dose and fewer instillations every 3 months or 6 months .
-METHODS	This was a prospective , randomized , multicenter study .
-METHODS	All patients had an intermediate - or high-risk non-muscle invasive bladder cancer .
-METHODS	They received three weekly instillations of one-third dose bacillus Calmette-Gurin every 6 months ( group I ) and two weekly instillations every 3 months ( group II ) during 3 years .
-METHODS	In the two schedules we assessed efficacy , tolerance , leukocyturia and prostate-specific antigen .
-RESULTS	No significant difference was observed between the two groups for recurrence at 6 , 12 or 18 months .
-RESULTS	At 2 years , tumor recurrence was observed in 10.9 % and muscle invasion in 2.9 % of cases .
-RESULTS	Bacillus Calmette-Gurin tolerance was comparable - the adverse events score was 0.8 in group I and 1 in group II ( P = 0.242 ) .
-RESULTS	No statistical correlation was observed between the adverse events score over 2 years , either for leukocyturia ( P = 0.8891 ) or prostate-specific antigen level ( P = 0.7155 ) .
-RESULTS	Leukocyturia level was not significantly associated with tumor recurrence or progression .
-CONCLUSIONS	One-third dose maintenance bacillus Calmette-Gurin is effective with no impact on tumor recurrence or muscle invasion .
-CONCLUSIONS	Furthermore , there seems to be no difference in tumor response or side-effects between patients receiving two or three maintenance instillations every 3 months or 6 months .
-CONCLUSIONS	In clinical practice , the use of leukocyturia or total prostate-specific antigen levels do not appear to be useful in predicting bacillus Calmette-Gurin toxicity .
-
-###25217488
-OBJECTIVE	To evaluate the usefulness of velocity ratio ( VR ) in patients with low gradient severe aortic stenosis ( LGSAS ) and preserved EF .
-BACKGROUND	LGSAS despite preserved EF represents a clinically challenging entity .
-BACKGROUND	Reliance on mean pressure gradient ( MPG ) may underestimate stenosis severity as has been reported in the context of paradoxical low flow , LGSAS .
-BACKGROUND	On the other hand , grading of stenosis severity by aortic valve area ( AVA ) may overrate stenosis severity due to erroneous underestimation of LV outflow tract ( LVOT ) diameter , small body size or inconsistencies in cut-off values for severe stenosis .
-BACKGROUND	We hypothesised that VR may have conceptual advantages over MPG and AVA , predict clinical outcomes and thereby be useful in the management of patients with LGSAS .
-METHODS	Patients from the prospective Simvastatin and Ezetimibe in Aortic Stenosis ( SEAS ) study with an AVA < 1.0 cm ( 2 ) , MPG40mmHg and EF55 % and asymptomatic at baseline were stratified according to VR with a cut-off value of 0.25 .
-METHODS	Outcomes were evaluated according to aortic valve-related events and cardiovascular death .
-RESULTS	Of 435 patients with LGSAS , 197 ( 45 % ) had VR < 0.25 suggesting severe and 238 ( 55 % ) had VR0 .25 suggesting non-severe stenosis .
-RESULTS	Aortic valve-related events ( mean follow-up 4214months ) were more frequent in patients with VR < 0.25 ( 57 % vs 41 % ; p < 0.001 ) as was cardiovascular death within the first 24months ( p < 0.05 ) .
-RESULTS	In multivariable Cox regression analysis , MPG was the strongest independent predictor of aortic valve events ( p < 0.001 ) followed by VR ( p < 0.02 ) .
-RESULTS	Adjusting AVA by VR increased predictive accuracy for aortic valve events ( area under the receiver operating curve 0.62 ( 95 % CI 0.57 to 0.67 ) vs 0.56 ( 95 % CI 0.51 to 0.61 ) for AVA , p = 0.02 ) with net reclassification improvement calculated at 0.36 ( 95 % CI 0.17 to 0.54 , p < 0.001 ) .
-RESULTS	VR did not improve the prediction of clinical events by MPG .
-CONCLUSIONS	In the difficult setting of LGSAS , VR shows a strong association with valve-related events and-although not outperforming MPG-may be particularly useful in guiding clinical management .
-BACKGROUND	NCT00092677 .
-
-###24944332
-OBJECTIVE	The objective was to assess the long-term safety profile of dual-release hydrocortisone ( DR-HC ) in patients with adrenal insufficiency ( AI ) .
-METHODS	Randomised , open-label , crossover trial of DR-HC or thrice-daily hydrocortisone for 3 months each ( stage 1 ) followed by two consecutive , prospective , open-label studies of DR-HC for 6 months ( stage 2 ) and 18 months ( stage 3 ) at five university clinics in Sweden .
-METHODS	Sixty-four adults with primary AI started stage 1 , and an additional 16 entered stage 3 .
-METHODS	Patients received DR-HC 20-40mg once daily and hydrocortisone 20-40mg divided into three daily doses ( stage 1 only ) .
-METHODS	Main outcome measures were adverse events ( AEs ) and intercurrent illness ( self-reported hydrocortisone use during illness ) .
-RESULTS	In stage 1 , patients had a median 1.5 ( range , 1-9 ) intercurrent illness events with DR-HC and 1.0 ( 1-8 ) with thrice-daily hydrocortisone .
-RESULTS	AEs during stage 1 were not related to the cortisol exposure-time profile .
-RESULTS	The percentage of patients with one or more AEs during stage 1 ( 73.4 % with DR-HC ; 65.6 % with thrice-daily hydrocortisone ) decreased during stage 2 , when all patients received DR-HC ( 51 % in the first 3 months ; 54 % in the second 3 months ) .
-RESULTS	In stages 1-3 combined , 19 patients experienced 27 serious AEs , equating to 18.6 serious AEs/100 patient-years of DR-HC exposure .
-CONCLUSIONS	This long-term prospective trial is the first to document the safety of DR-HC in patients with primary AI and demonstrates that such treatment is well tolerated during 24 consecutive months of therapy .
-
-###25029619
-BACKGROUND	Low-fat and low-carbohydrate weight-loss diets can have a beneficial effect on longitudinal measures of blood pressure and blood lipids .
-BACKGROUND	We aimed to assess longitudinal changes in blood pressure and blood lipids in a population of premenopausal women .
-BACKGROUND	We hypothesized that results may differ by level of adherence to the respective diet protocol and baseline presence of hypertension or hyperlipidemia .
-METHODS	Overweight or obese premenopausal women were randomized to a low-fat ( n = 41 ) or low-carbohydrate ( n = 38 ) diet .
-METHODS	As part of the 52-week Lifestyle Eating and Fitness ( LEAF ) intervention trial , we fit linear mixed models to determine whether a change in outcome differed by treatment arm .
-RESULTS	Within-group trends in blood pressure and blood lipids did not differ ( p > 0.30 ) .
-RESULTS	Across study arms , there was a significant decrease in systolic blood pressure ( SBP , 3mm Hg , p = 0.01 ) over time , but diastolic blood pressure ( DBP ) did not change significantly over the course of the study .
-RESULTS	Blood lipids ( total cholesterol [ TC ] , low-density lipoproteins [ LDL ] , and high-density lipoproteins [ HDL ] ) all exhibited nonlinear trends over time ( p < 0.01 ) ; each decreased initially but returned to levels comparable to baseline by study conclusion ( p > 0.20 ) .
-RESULTS	We observed a decline in SBP among women who were hypertensive at baseline ( p < 0.01 ) , but hypercholesterolemia at baseline did not affect trends in blood lipids ( p > 0.40 ) .
-CONCLUSIONS	Our results support that dietary interventions may be efficacious for lowering blood pressure and blood lipids among overweight or obese premenopausal women .
-CONCLUSIONS	However , a decrease in SBP was the only favorable change that was sustained in this study population .
-CONCLUSIONS	These changes can be maintained over the course of a 1-year intervention , yet changes in blood lipids may be less sustainable .
-
-###24767098
-BACKGROUND	Intrafraction tumour motion in helical tomotherapy was investigated by comparing pre - and mid-fraction CT scans in patients with early non-small cell lung carcinoma ( NSCLC ) to assess the efficacy of a 7-mm margin around gross tumour volumes ( GTVs ) in stereotactic body radiation therapy ( SBRT ) .
-METHODS	Thirty patients with early-stage NSCLC received SBRT in four or five fractions for a total of 141 treatments .
-METHODS	A slow positron emission tomography/CT scan was fused with the simulation CT to determine the GTV .
-METHODS	A planning target volume was created by placing an isotropic margin of 7mm around the GTV .
-METHODS	Data were retrospectively analyzed to assess translational tumour positional changes along the x , y and z axes and vector changes in millimeters from the pretreatment megavoltage ( MV ) - CT to the mid-fraction MV-CT .
-RESULTS	Average movements for all 141 treatment days along the x , y and z axes were 0.52.3 , -0.33.0 and 0.93.0 mm , respectively .
-RESULTS	Average movements for each patient along the x , y and z axes were 0.51.5 , -0.22.0 and 0.91.9 mm , respectively .
-RESULTS	Average vector displacement was 4.32.4 mm for all treatment days and 4.21.7 mm for each patient .
-RESULTS	Of 141 treatments , 137 ( 97.2 % ) fell within 7.0 mm in all axes .
-CONCLUSIONS	The addition of a 7-mm margin to the GTV for patients receiving SBRT for NSCLC using tomotherapy is adequate to account for tumour movement .
-CONCLUSIONS	Mid-fraction CT scans proved to be valuable in assessing intrafraction tumour motion .
-
-###25545858
-OBJECTIVE	Standard varenicline tartrate dosing was formulated to avoid adverse effects ( primarily nausea ) , but some patients may be underdosed .
-OBJECTIVE	To our knowledge , no evidence-based guidance exists for physicians considering increasing varenicline dose if there is no response to the standard dosage .
-OBJECTIVE	To determine whether increasing varenicline dose in patients showing no response to the standard dosage improves treatment efficacy .
-METHODS	In a double-blind randomized placebo-controlled trial , 503 smokers attending a stop smoking clinic commenced varenicline use 3 weeks before their target quit date ( TQD ) .
-METHODS	Two hundred participants reporting no strong nausea , no clear reduction in smoking enjoyment , and less than 50 % reduction in their baseline smoking on day 12 received additional tablets of varenicline or placebo .
-METHODS	All participants began standard varenicline tartrate dosing , gradually increasing to 2 mg/d .
-METHODS	Dose increases of twice-daily varenicline ( 0.5 mg ) or placebo took place on days 12 , 15 , and 18 ( up to a maximum of 5 mg/d ) .
-METHODS	Participants rated their smoking enjoyment during the prequit period and withdrawal symptoms weekly for the first 4 weeks after the TQD .
-METHODS	Continuous validated abstinence rates were assessed at 1 , 4 , and 12 weeks after the TQD .
-RESULTS	The dose increase reduced smoking enjoyment during the prequit period , with mean ( SD ) ratings of 1.7 ( 0.8 ) for varenicline vs 2.1 ( 0.7 ) for placebo ( P = .001 ) .
-RESULTS	It had no effect on the mean ( SD ) frequency of urges to smoke at 1 week after the TQD , their strength , or the severity of withdrawal symptoms : these ratings for varenicline vs placebo were 2.7 ( 1.1 ) vs 2.6 ( 0.9 ) ( P = .90 ) , 2.6 ( 1.1 ) vs 2.8 ( 1.0 ) ( P = .36 ) , and 1.5 ( 0.4 ) vs 1.6 ( 0.5 ) ( P = .30 ) , respectively .
-RESULTS	The dose increase also had no effect on smoking cessation rates for varenicline vs placebo at 1 week ( 37 [ 37.0 % ] vs 48 [ 48.0 % ] , P = .14 ) , 4 weeks ( 51 [ 51.0 % ] vs 59 [ 59.0 % ] , P = .32 ) , and 12 weeks ( 26 [ 26.0 % ] vs 23 [ 23.0 % ] , P = .61 ) after the TQD .
-RESULTS	There was significantly more nausea ( P < .001 ) and vomiting ( P < .001 ) reported in the varenicline arm than in the placebo arm .
-CONCLUSIONS	Increasing varenicline dose in smokers with low response to the drug had no significant effect on tobacco withdrawal symptoms or smoking cessation .
-CONCLUSIONS	Physicians often consider increasing the medication dose if there is no response to the standard dosage .
-CONCLUSIONS	This approach may not work with varenicline .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01206010 .
-
-###24874316
-OBJECTIVE	To assess the efficacy of the cytoprotective neuropeptide cortexin in the complex treatment in acute and early rehabilitation stages of ischemic stroke ( II ) .
-METHODS	A multicenter prospective double-blind placebo-controlled trial has been carried out .
-METHODS	Two hundreds and seventy-two patients with II have been enrolled in the trial .
-METHODS	Cortexin was administered in low doses ( 10 mg three times a day intramuscular , using the following schemes : group 1 : 2 courses of cortexin ; group 2 : 1 course of cortexin with the following course of placebo ; group 3 : two courses of placebo .
-METHODS	The duration of treatment was 70 days .
-METHODS	Patients were examined during 4 visits using clinical tests and instrumental methods .
-RESULTS	High efficacy and safety of cortexin in the complex treatment of patients with II has been shown .
-RESULTS	The best therapeutic effect was seen in group 1 ( two 10-day courses of cortexin ) .
-RESULTS	The results were confirmed by the pharmacoeconomic analysis of treatment tactics based on the estimation of `` net monetary benefit '' .
-CONCLUSIONS	Cortexin is recommended for treatment and rehabilitation of patients with II .
-
-###25936187
-OBJECTIVE	To compare postoperative blood loss under different negative pressures of drainage after total hip arthroplasty for the treatment of femoral neck fractures .
-METHODS	From January 1st to December 30th 2013 , 74 patients with femoral neck fractures treated with total hip arthroplasty were randomly divided into two groups : high negative pressure drainage group and low negative pressure drainage group .
-METHODS	In high negative pressure drainage group , there were 34 cases including 10 males and 24 females , with a mean age of ( 75.94 9.02 ) years old , and the patients were treated with 60 kPa negative pressure of drainage .
-METHODS	In the low negative pressure drainage group , there were 40 cases including 13 males and 27 females , with an average age of ( 74.93 8.90 ) years old , and the patients were treated with 30 kPa negative pressure of drainage .
-METHODS	The amount of total drainage , total blood loss , and hemoglobin change were compared between these two groups .
-RESULTS	All the patients got primary healing without infections .
-RESULTS	In high negative pressure drainage group , the change of hemoglobin was ( 41.74 15.69 ) g/L , total blood loss was ( 1,217.73 459.50 ) ml and the drainage volume was ( 312.94 103.44 ) ml ; while in low negative pressure drainage group , the results were ( 34.90 12.90 ) g/L , ( 904.01 381.58 ) ml and ( 129.25 44.25 ) ml separately .
-RESULTS	All the results in high negative pressure drainage group were higher than those in the other group .
-RESULTS	Three days after operation , the change of hemoglobin was ( 46.00 13.29 ) g/L and total blood loss was ( 1,304.72 421.75 ) ml ; while in low negative pressure drainage group , the changes of hemoglobin was ( 43.87 11.39 ) g/L and total blood loss was ( 1,196.78 344.20 ) ml ; there were no statistically significant differences between two groups .
-CONCLUSIONS	When placing drainage devices after total hip arthroplasty for the treatment of femoral neck fractures , the level of negative pressure should be chosen according to preoperative level of hemoglobin and HCT in patients .
-CONCLUSIONS	For old patients with femoral neck fracture , low negative pressure is more suitable .
-
-###24280475
-OBJECTIVE	One objective of this study was to assess the effects of laughter on the psychological , immunological and physiological systems of the body .
-OBJECTIVE	Another objective was to introduce the Laughing Qigong Program ( LQP ) , as a method of standardization for simulated laughter interventions .
-METHODS	A randomized , prospective , experimental study of the LQP was conducted in a group of adolescents ( n = 67 ) in Taiwan .
-METHODS	During study-hall sessions , experimental subjects ( n = 34 ) attended the LQP for eight-weeks .
-METHODS	Simultaneously , control subjects ( n = 33 ) read or did their homework .
-METHODS	All subjects were tested before and after the intervention on the following : Rosenberg Self-Esteem scale ( RSE ) , Chinese Humor Scale ( CHS ) and Face Scale ( FS ) as psychological markers ; saliva cortisol ( CS ) as an immunological marker ; blood pressure ( BP ) , heart rate ( HR ) , and heart rate variability ( HRV ) as physiological markers of the body 's response to stress .
-METHODS	Mood states ( FS ) were measured before/after each LQP session .
-RESULTS	Mood states ( p = .00 ) and humor ( p = .004 ; p = .003 ) improved in the experimental group ; no significant changes were found in the controls ( p = 69 ; p = 60 ) .
-RESULTS	The immunological marker of stress , cortisol levels , decreased significantly for those who participated in the LQP ( p = .001 ) , suggesting lower levels of stress after completion of the program .
-CONCLUSIONS	The LQP is a non-pharmacological and cost-effective means to help adolescents mitigate stresses in their everyday life .
-
-###25077420
-BACKGROUND	Neisseria meningitidis serogroup B ( MnB ) is a major cause of invasive meningococcal disease in infants .
-BACKGROUND	A conserved , surface-exposed lipoprotein , LP2086 ( a factor H-binding protein [ fHBP ] ) , is a promising MnB vaccine target .
-BACKGROUND	A bivalent , recombinant vaccine targeting the fHBP ( rLP2086 ) of MnB was developed .
-METHODS	This phase 1/2 clinical study was designed to assess the immunogenicity , safety , and tolerability of a 4-dose series of the rLP2086 vaccine at 20 - , 60 - , 120 - , or 200-g dose levels in vaccine-naive infants when given with routine childhood vaccines .
-METHODS	The study was to consist of two phases : a single-blind sentinel phase and an open-label full enrollment phase .
-METHODS	During the sentinel phase , randomization of subjects to the next higher dose was delayed pending a 14-day safety review of dose 1 of the preceding dose cohort .
-METHODS	The full enrollment phase was to occur after completion of the sentinel phase .
-RESULTS	Local reactions were generally mild and adverse events infrequent ; however , after only 46 infants were randomized into the study , fever rates were 64 % and 90 % in subjects receiving one 20 - or 60-g rLP2086 dose , respectively .
-RESULTS	Most fevers were < 39.0 C. Only 2 subjects in the 20-g group and 1 subject in the 60-g group experienced fevers > 39.0 C ; no fevers were > 40.0 C. Due to these high fever rates , the study was terminated early .
-RESULTS	No immunogenicity data were collected .
-RESULTS	This report discusses the safety and acceptability of rLP2086 in infants after one 20 - or 60-g dose .
-CONCLUSIONS	Due to the high fever rate experienced in the 20 - and 60-g groups , rLP2086 in the current formulation may not be acceptable for infants .
-
-###24228533
-OBJECTIVE	To compare effects of integrated treatment traditional Chinese medicine and Western medicine ( TCM-WM ) and simple western medicine on TCM clincal symptoms in the patient of AIDS with pulmonary inflammation .
-METHODS	A multicenter randomized controlled trials of 164 subjects evaluated the effects of clinical symptoms of AIDS with pulmonary inflammation of TWO regimens : the TCM-WM group ( n = 111 ) and western medicine treatment group ( n = 53 ) , while incidence of TCM symptoms in different time points in two groups were analyzed .
-RESULTS	Twenty eight days after treatment , the cured and markedly effective rate of TCM symptoms in the TCM-WM group significantly exceeding that in the western medicine treatment group ( cured and markedly effective rate significant efficiency 44.55 % vs 20.00 % ) , while the incidence rate for the TCM symptoms of fever and headache in the TCM-WM group was significantly lower than that in western medicine group .
-CONCLUSIONS	The integrated treatment of traditional Chinese medicine and Western medicine helps to alleviate the TCM clinical symptoms of AIDS with pulmonary inflammation .
-
-###25239928
-OBJECTIVE	We evaluated the effects of cognitive speed of processing training ( SOPT ) on the development of additional Instrumental Activities of Daily Living ( IADL ) difficulties and the reduction of depressive symptoms in the Iowa Healthy and Active Minds Study ( IHAMS ) .
-METHODS	Six hundred eighty-one patients were randomized to 4 groups : 10 hr of on-site SOPT , 10 hr of on-site SOPT plus 4 hr of boosters , 10 hr of at-home SOPT , or 10 hr of on-site attention-control ( crossword puzzles ) .
-METHODS	Developing additional difficulties with IADLs and reductions in depressive symptoms 1 year later were evaluated using multiple logistic regression .
-RESULTS	The on-site SOPT with boosters group had reduced odds of developing additional difficulties with IADLs ( adjusted odds ratio [ AOR ] = 0.45 , p = .044 ) compared with attention-controls .
-RESULTS	The on-site SOPT with boosters group also had increased odds of reduced depressive symptom levels ( AOR = 2.93 , p = .003 ) compared with attention-controls .
-CONCLUSIONS	These findings provide evidence that SOPT transfers beyond the cognitive skills trained to meaningful downstream improvements in the lives of middle-aged and older adults .
-
-###25159241
-BACKGROUND	The success of damage-control surgery ( DCS ) for the treatment of trauma has led to its use in other surgical problems such as abdominal sepsis .
-BACKGROUND	Previous studies using direct peritoneal resuscitation ( DPR ) for the treatment of trauma have yielded promising results .
-BACKGROUND	We present the results of the application of this technique to patients experiencing abdominal sepsis .
-METHODS	We enrolled 88 DCS patients during a 5 year-period ( January 2008 to December 2012 ) into a propensity-matched study to evaluate the utility of using DPR in addition to standard resuscitation .
-METHODS	DPR consisted of peritoneal lavage with 2.5 % DELFLEX , and abdominal closure was standardized across both groups .
-METHODS	Patients were matched using Acute Physiology and Chronic Health Evaluation II ( APACHE II ) variables .
-METHODS	Univariate and multivariate analyses were performed .
-RESULTS	There were no differences between the control and experimental groups with regard to age , sex , ethnicity , or APACHE II at 24 hours .
-RESULTS	Indications for damage control included pancreatitis , perforated hollow viscous , bowel obstruction , and ischemic enterocolitis .
-RESULTS	Patients undergoing DPR had both a higher rate of ( 68 % vs. 43 % , p < 0.03 ) and a shorter time to definitive fascial closure ( 5.9 [ 3.2 ] days vs. 7.7 [ 4.1 ] days , p < 0.02 ) .
-RESULTS	DPR patients had a decreased APACHE II and Sequential Organ Failure Assessment ( SOFA ) score compared with the controls at 48 hours .
-RESULTS	In addition , DPR patients had fewer abdominal complications compared with the controls ( RR , 0.57 ; 95 % confidence interval , 0.32-1 .01 ; p = 0.038 ) .
-RESULTS	Ventilator days and intensive care unit length of stay were both significantly reduced in the DPR group .
-RESULTS	The DPR group showed a lower overall mortality at 30 days ( 16 % vs. 27 % , p = 0.15 ) .
-CONCLUSIONS	DPR reduces time to definitive abdominal closure , increases primary fascial closure , and reduces intra-abdominal complications following DCS .
-CONCLUSIONS	DPR may also attenuate progressive physiologic injury as demonstrated by a reduction in 48-hour intensive care unit severity scores .
-CONCLUSIONS	As a result , DPR following DCS may afford better outcomes to patients experiencing shock .
-METHODS	Therapeutic study , level III .
-
-###24364223
-BACKGROUND	The importance of vitamin D on bone health and osteoporosis was studied by many researchers .
-BACKGROUND	The main role of the Vitamin D is to absorb calcium and phosphate and increase bone mineralization .
-BACKGROUND	Older people are at an increased risk of the inadequate vitamin D production in the skin because of lower sun exposure and reduced ability of the skin to synthesize vitamin D.
-OBJECTIVE	The aim of this clinical trial was to evaluate the efficacy and tolerability of short-term ( 2 weeks ) low energy UVB irradiation in postmenopausal women with osteoporosis using bone mineral density and bone turnover markers .
-METHODS	A three-month , single-blinded , randomized , placebo-controlled clinical trial was conducted at the University hospital in Daegu , Republic of Korea .
-METHODS	Fifty-two postmenopausal Korean women ( older than 65 years ) with osteoporosis were randomly allocated to have either low energy UVB or placebo for 30 minutes a day for two weeks of treatment during winter .
-METHODS	Laboratory analysis and physical examination before and 4 , 8 and 12 weeks after treatment were carried out and BMD was measured before and 8 and 12 weeks after treatment .
-METHODS	The effects of time and treatment interaction between these two groups were evaluated by repeated-measure two-factor analysis , and subgroup analysis was performed to examine UVB effect on the vitamin D insufficient group [ serum 25 ( OH ) D3 concentration < 30 ng/mL ] .
-RESULTS	In vitamin D insufficient group , the effect of UVB irradiation on vitamin D and bone ALP as well as additional benefit on bone formation was confirmed .
-RESULTS	The vitamin D insufficient group showed statistically significant increment in serum 25 ( OH ) D3 compared with the normal group ( p < 0.05 ) .
-RESULTS	However , there was no significant difference between two groups in the other bone turnover markers , such as serum calcium , PTH-C , serum osteocalcin , serum CTX and BMD .
-CONCLUSIONS	Low-energy-short-term UVB radiation for postmenopausal women may be of use in vitamin D synthesis .
-CONCLUSIONS	There was a modest benefit in change of bone ALP especially in women with the insufficient vitamin D.
-
-###24816725
-OBJECTIVE	This phase II study evaluated the synthetic DNA-based immunomodulator and Toll-like receptor 9 agonist MGN1703 as maintenance treatment in metastatic colorectal carcinoma ( mCRC ) .
-METHODS	Fifty-nine patients with mCRC and disease control after standard first-line chemotherapy were randomised to MGN1703 60mg ( N = 43 ) or placebo ( N = 16 ) .
-RESULTS	The hazard ratio ( HR ) for the primary endpoint [ progression-free survival ( PFS ) from the start of maintenance ] was 0.56 ( 95 % CI 0.29-1 .08 ; P = 0.07 ) and 0.55 ( 95 % CI 0.3-1 .0 ; P = 0.04 ) by independent and investigator review , respectively .
-RESULTS	MGN1703 significantly improved PFS measured from the start of induction therapy versus placebo on independent ( HR 0.49 ; 95 % CI 0.26-0 .94 ; P = 0.03 ) and investigator review ( HR 0.50 ; 95 % CI 0.31-1 .02 ; P = 0.02 ) .
-RESULTS	Overall survival ( OS ) data remain immature ( HR 95 % ; 95 % CI 0.3-1 .5 ; P = 0.29 ) with 28/43 patients alive after a medium follow-up of > 17months .
-RESULTS	Retrospective subgroup analysis showed a significant effect of MGN1703 on PFS versus placebo in patients with greater than median tumour size reduction and normalised carcinoembryonic antigen concentrations following induction therapy , and in patients with elevated activated NKT cells3 .08 % .
-RESULTS	Adverse events were mild to moderate and limited to injection-site reactions or linked to general immune system activation .
-CONCLUSIONS	MGN1703 maintenance treatment was well tolerated and appears to induce durable and prolonged PFS and disease control in a subgroup of patients with mCRC following induction therapy .
-CONCLUSIONS	Activated NKT cells may be a predictive biomarker for selecting patients likely to benefit more from MGN1703 .
-
-###25539805
-BACKGROUND	Rheumatoid Arthritis ( RA ) is one of the most common autoimmune diseases , affecting approximately 1 % of the UK adult population .
-BACKGROUND	Patients suffer considerable pain , stiffness and swelling and can sustain various degrees of joint destruction , deformity , and significant functional decline .
-BACKGROUND	In addition , the economic burden due to hospitalisation and loss of employment is considerable , with over 50 % of patients being work-disabled within 10years of diagnosis .
-BACKGROUND	Despite several biologic disease modifying anti-rheumatic drugs ( bDMARD ) now available , there is a lack of data to guide biologic sequencing .
-BACKGROUND	In the UK , second-line biologic treatment is restricted to a single option , rituximab .
-BACKGROUND	The aim of the SWITCH trial is to establish whether an alternative-mechanism-TNF-inhibitor ( TNFi ) or abatacept are as effective as rituximab in patients with RA who have failed an initial TNFi drug .
-METHODS	SWITCH is a pragmatic , phase IV , multi-centre , parallel-group design , open-label , randomised , controlled trial ( RCT ) comparing alternative-mechanism-TNFi and abatacept with rituximab in patients with RA who have failed an initial TNFi drug .
-METHODS	Participants are randomised in a 1:1:1 ratio to receive alternative mechanism TNFi , ( monoclonal antibodies : infliximab , adalimumab , certolizumab or golimumab or the receptor fusion protein , etanercept ) , abatacept or rituximab during the interventional phase ( from randomisation up to week 48 ) .
-METHODS	Participants are subsequently followed up to a maximum of 96weeks , which constitutes the observational phase .
-METHODS	The primary objective is to establish whether an alternative-mechanism-TNFi or abatacept are non-inferior to rituximab in terms of disease response at 24weeks post randomisation .
-METHODS	The secondary objectives include the comparison of alternative-mechanism-TNFi and abatacept to rituximab in terms of disease response , quality of life , toxicity , safety and structural and bone density outcomes over a 12-month period ( 48weeks ) and to evaluate the cost-effectiveness of switching patients to alternative active therapies compared to current practice .
-CONCLUSIONS	SWITCH is a well-designed trial in this therapeutic area that aims to develop a rational treatment algorithm to potentially inform personalised treatment regimens ( as opposed to switching all patients to only one available ( and possibly unsuccessful ) therapy ) , which may lead to long-term improved patient outcomes and gains in population health .
-BACKGROUND	UKCRN Portfolio ID : 12343 ; ISRCTN89222125 ; NCT01295151 .
-
-###24888266
-BACKGROUND	There is a need for evidence of the clinical effectiveness of minimally invasive surgery for the treatment of esophageal cancer , but randomized controlled trials in surgery are often difficult to conduct .
-BACKGROUND	The ROMIO ( Randomized Open or Minimally Invasive Oesophagectomy ) study will establish the feasibility of a main trial which will examine the clinical and cost-effectiveness of minimally invasive and open surgical procedures for the treatment of esophageal cancer .
-METHODS	A pilot randomized controlled trial ( RCT ) , in two centers ( University Hospitals Bristol NHS Foundation Trust and Plymouth Hospitals NHS Trust ) will examine numbers of incident and eligible patients who consent to participate in the ROMIO study .
-METHODS	Interventions will include esophagectomy by : ( 1 ) open gastric mobilization and right thoracotomy , ( 2 ) laparoscopic gastric mobilization and right thoracotomy , and ( 3 ) totally minimally invasive surgery ( in the Bristol center only ) .
-METHODS	The primary outcomes of the feasibility study will be measures of recruitment , successful development of methods to monitor quality of surgery and fidelity to a surgical protocol , and development of a core outcome set to evaluate esophageal cancer surgery .
-METHODS	The study will test patient-reported outcomes measures to assess recovery , methods to blind participants , assessments of surgical morbidity , and methods to capture cost and resource use .
-METHODS	ROMIO will integrate methods to monitor and improve recruitment using audio recordings of consultations between recruiting surgeons , nurses , and patients to provide feedback for recruiting staff .
-CONCLUSIONS	The ROMIO study aims to establish efficient methods to undertake a main trial of minimally invasive surgery versus open surgery for esophageal cancer .
-BACKGROUND	The pilot trial has Current Controlled Trials registration number ISRCTN59036820 ( 25/02/2013 ) at http://www.controlled-trials.com; the ROMIO trial record at that site gives a link to the original version of the study protocol .
-
-###24907722
-OBJECTIVE	Posttransplant anemia is associated with an increased risk of congestive heart failure , left ventricular hypertrophy , and death .
-OBJECTIVE	The purpose of this study was to evaluate the effect of long-acting erythropoietin-stimulating agents on anemia after kidney transplant .
-METHODS	In 2306 kidney transplant recipients , 250 anemic patients ( 11 % ) with stable graft function were followed at the Hamed Al-Essa Organ Transplant Centre ( Kuwait ) and were assessed for anemia .
-METHODS	We enrolled 120 patients into this open-label study in 2 groups : group 1 had treatment with darbepoetin alfa ( 86 patients ) and group 2 had continuous erythropoietin receptor activator ( 34 patients ) .
-RESULTS	Patient age correlated negatively with serum iron level .
-RESULTS	Serum ferritin correlated negatively with hemoglobin level 6 months after transplant but not at time of transplant .
-RESULTS	Most patients were women who received their grafts from male donors .
-RESULTS	The 2 groups were comparable in frequency of rejection and mean hemoglobin and serum albumin levels at 3 , 6 , 9 , and 12 months after transplant .
-RESULTS	There was no difference between the 2 groups in renal function ( estimated glomerular filtration rate ) ; posttransplant complications such as new-onset diabetes after transplant , hypertension , serious bacterial infections , or patient and graft outcomes .
-CONCLUSIONS	Anemia is an important problem after kidney transplant , and iron use is suboptimal in kidney transplant recipients .
-CONCLUSIONS	Darbepoetin alfa and continuous erythropoietin receptor activator had comparable positive results .
-
-###25541155
-BACKGROUND	This study evaluates persistence and severity of docetaxel-induced neuropathy ( peripheral neuropathy ( PN ) ) and impact on health related quality of life in survivors from early-stage breast cancer .
-METHODS	One thousand and thirty-one patients with early-stage breast cancer , who received at least one cycle of docetaxel and provided information on PN during treatment , completed questionnaires on PN as an outcome ( Common Toxicity Criteria ( CTC ) scores , European Organisation for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy 20 ( EORTC CIPN20 ) and EORTC Quality of Life Questionnaire ( QLQ ) - C30 ) after 1-3years .
-RESULTS	Upon completion of docetaxel treatment , 241 patients ( 23 % ) reported PN , grades 2-4 .
-RESULTS	PN persisted for 1-3years among 81 ( 34 % ) while PN regressed to grades 0-1 among 160 ( 66 % ) .
-RESULTS	Among 790 patients ( 77 % ) without PN , 76 ( 10 % ) developed PN 1-3years later while 714 ( 90 % ) stayed free from PN .
-RESULTS	Significant risk factors for persistent PN were age 55 ( p = 0.001 ) , maximum grade of PN during docetaxel treatment ( p < 0.0001 ) , persistent muscle and joint pain ( p < 0.0001 ) , stomatitis ( p = 0.047 ) and fatigue ( p = 0.001 ) .
-RESULTS	Persistent PN had a significant negative correlation with health-related quality of life ( HRQOL ) , functional scales and symptom scales .
-CONCLUSIONS	Overall , 15 % of breast cancer survivors treated with docetaxel report PN 1-3years after treatment with a significant negative impact on HRQOL .
-
-###24665014
-BACKGROUND	A multivariable training has a positive impact on balance skills and risk of injury .
-BACKGROUND	To date the effect of this training using the Nintendo Wii balance board in sportive people has not yet been investigated .
-OBJECTIVE	The aim of this study was to investigate whether training with the Nintendo Wii balance board can improve balance skills .
-METHODS	20 people were randomized into a control and an intervention group each with 10 people who performed a unilateral stance test with eyes open and closed as well as the star excursion balance test before and after the intervention .
-METHODS	The control group completed their usual sports and the intervention group an adjunct training with the Nintendo Wii balance board for 4 weeks .
-RESULTS	Adjunct Training using the Nintendo Wii Balance Board did not improve sportive people 's balance skills significantly .
-RESULTS	The intervention group , however , attained better results in the star excursion balance test , whereas the control group did not show any changes .
-RESULTS	The unilateral stance tests did not provide significant differences before and after training within both groups .
-CONCLUSIONS	The use of the Nintendo Wii balance board should be further investigated by employing individual difficulty levels .
-
-###24723218
-OBJECTIVE	Although some studies suggest that art therapy may be useful in the treatment of negative symptoms of schizophrenia , a recent large trial of group art therapy found no clinical advantage over standard care , but the study population was heterogeneous and uptake of the intervention was poor .
-OBJECTIVE	This study aimed to investigate whether art therapy was more effective for specific subgroups of patients .
-METHODS	Secondary analysis of data from a randomised controlled trial of group art therapy as an adjunctive treatment for schizophrenia ( n = 140 ) versus standard care alone ( n = 137 ) .
-METHODS	Positive and Negative Syndrome Scale scores at 12 months were compared between trial arms .
-METHODS	Interaction between intervention effect and different subgroups , including those with more severe negative symptoms of schizophrenia , and those who expressed a preference for art therapy prior to randomisation , was tested using a linear mixed model .
-RESULTS	The clinical effectiveness of group art therapy did not significantly differ between participants with more or less severe negative symptoms [ interaction for difference in PANSS = 1.7 , 95 % CI ( -8.6 to 12.1 ) , P = 0.741 ] , or between those who did and did not express a preference for art therapy [ interaction = 3.9 , 95 % CI ( -6.7 to 14.5 ) , P = 0.473 ] .
-RESULTS	None of the other exploratory subgroups suggested differences in intervention effect .
-CONCLUSIONS	There was no evidence of greater improvement in clinical symptoms of schizophrenia for those with more severe negative symptoms or those with a preference for art therapy .
-CONCLUSIONS	Identification of patients with schizophrenia who may benefit most from group art therapy remains elusive .
-
-###24668359
-OBJECTIVE	To investigate the feasibility and potential efficacy of the Nintendo Wii for balance rehabilitation after stroke .
-METHODS	Phase II , single-blind , randomized controlled trial .
-METHODS	Inpatient rehabilitation facility .
-METHODS	Thirty adults ( mean age 63.6 ( 14.7 ) years ) undergoing inpatient rehabilitation who were less than three months post-stroke and able to stand unsupported .
-METHODS	Participants were allocated to a Balance Group , using the ` Wii Fit Plus ' in standing , or Upper Limb Group , using the ` Wii Sports/Sports Resort ' in sitting .
-METHODS	Both groups undertook three 45 minute sessions per week over two to four weeks in addition to standard care .
-METHODS	The primary focus was feasibility , addressed by recruitment , retention , adherence , acceptability and safety .
-METHODS	Efficacy was evaluated by balance , mobility and upper limb outcomes .
-RESULTS	Twenty-one percent of individuals screened were recruited and 86 % ( n = 30 ) of eligible people agreed to participate .
-RESULTS	Study retention and session adherence was 90 % and > 99 % , respectively , at two weeks ; dropping to 70 % and 87 % at four weeks due to early discharge .
-RESULTS	All participants reported enjoying the sessions and most felt they were beneficial .
-RESULTS	No major adverse events occurred .
-RESULTS	Wii use by the Balance Group was associated with trends for improved balance , with significantly greater improvement in outcomes including the Step Test and Wii Balance Board-derived centre of pressure scores .
-RESULTS	The Upper Limb Group had larger , non-significant changes in arm function .
-CONCLUSIONS	A Wii-based approach appears feasible and promising for post-stroke balance rehabilitation .
-CONCLUSIONS	A larger randomized controlled trial is recommended to further investigate efficacy .
-
-###24807158
-BACKGROUND	Poor prognosis patients with bulky stage III locally advanced non-small-cell lung cancer may not be offered concurrent chemoradiotherapy ( CRT ) .
-BACKGROUND	Following a phase III trial concerning the effect of palliative CRT in inoperable poor prognosis patients , this analysis was performed to explore how tumor size influenced survival and health-related quality of life ( HRQOL ) .
-METHODS	A total of 188 poor prognosis patients recruited in a randomized clinical trial received four courses intravenous carboplatin day 1 and oral vinorelbine day 1 and 8 , at 3-week intervals .
-METHODS	The experimental arm ( N = 94 ) received radiotherapy with fractionation 42 Gy/15 , starting at the second chemotherapy course .
-METHODS	This subset study compares outcomes in patients with tumors larger than 7 cm ( N = 108 ) versus tumors 7 cm or smaller ( N = 76 ) .
-RESULTS	Among those with tumors larger than 7 cm , the median overall survival in the chemotherapy versus CRT arm was 9.7 and 13.4 months , respectively ( p = 0.001 ) .
-RESULTS	The 1-year survival was 33 % and 56 % , respectively ( p = 0.01 ) .
-RESULTS	Except for a temporary decline during treatment , HRQOL was maintained in the CRT arm , regardless of tumor size .
-RESULTS	Among those who did not receive CRT , patients with tumors larger than 7 cm experienced a gradual decline in the HRQOL .
-RESULTS	The CRT group had significantly more esophagitis and hospitalizations because of side effects regardless of tumor size .
-CONCLUSIONS	In patients with poor prognosis and inoperable locally advanced non-small-cell lung cancer , large tumor size should not be considered a negative predictive factor .
-CONCLUSIONS	Except for performance status 2 , patients with tumors larger than 7 cm apparently benefit from CRT .
-
-###25595177
-OBJECTIVE	To evaluate the role of intravitreal aflibercept injection as a treatment for eyes with chronic central serous chorioretinopathy ( CSCR ) .
-METHODS	This prospective pilot study enrolled 12 patients with chronic CSCR who received a 6-month treatment regimen of intravitreal aflibercept .
-METHODS	Patients were followed with monthly Early Treatment of Diabetic Retinopathy Study ( ETDRS ) best-corrected visual acuity ( BCVA ) and spectral domain optical coherence tomography ( SD-OCT ) with enhanced depth imaging .
-RESULTS	All patients were men between 29 and 64years ( median 55 ) .
-RESULTS	Subfoveal fluid was present on OCT for a median duration of 6months ( range 4-29months ) prior to treatment .
-RESULTS	Baseline BCVA ranged from 20/25 to 20/160 ( median 20/50 ) with a mean of 62 ( SD = 13 ) ETDRS letters .
-RESULTS	No patients experienced serious ocular or systemic adverse events over the course of the study .
-RESULTS	Post-treatment BCVA ranged from 20/20 to 20/200 ( median 20/40 ) , with a mean of 64 ( SD = 16 ) ETDRS letters ( p = 0.56 ) .
-RESULTS	At baseline , three patients ( 25 % ) had BCVA of 20/40 versus seven patients ( 58 % ) at the conclusion of the study .
-RESULTS	Two patients gained at least 15 ETDRS letters and no patients lost more than 15 ETDRS letters .
-RESULTS	Six of 12 patients ( 50 % ) had complete resolution of subfoveal fluid .
-RESULTS	Mean central macular thickness decreased from 400m ( SD = 104m ) to 306m ( SD = 94m ) ( p = 0.03 ) , and mean subfoveal fluid decreased from 159m ( SD = 93m ) to 49m ( SD = 68m ) ( p = 0.02 ) .
-RESULTS	Mean choroidal thickness decreased from 307m ( SD = 72m ) to 263m ( SD = 63m ) ( p = 0.0003 ) .
-CONCLUSIONS	Intravitreal aflibercept was well tolerated over a 6-month treatment course for chronic CSCR .
-CONCLUSIONS	No change was observed in visual acuity metrics .
-CONCLUSIONS	Anatomic trends may suggest some morphological activity , but larger controlled trials are needed .
-BACKGROUND	NCT01710332 .
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-###24474383
-BACKGROUND	Serum infliximab trough levels correlate with efficacy ; dose escalation is often beneficial in patients with Crohn 's disease who stop responding to infliximab treatment .
-OBJECTIVE	To carry out a post hoc analysis of A Crohn 's Disease Clinical Trial Evaluating Infliximab in a New Long-term Treatment Regimen I ( ACCENT I ) to evaluate the association between serum infliximab trough levels and C-reactive protein ( CRP ) after 14weeks of induction treatment with durable sustained long-term response ( Crohn 's Disease Activity Index decrease 70 points and reduction 25 % from baseline ) .
-METHODS	ACCENT I was a multicentre , randomised , placebo-controlled study .
-METHODS	Week 14 trough levels and CRP percentage decrease from baseline to week 14 were compared between patients with and without durable sustained response through week 54 .
-METHODS	Sensitivity and specificity were determined to predict durable sustained response .
-METHODS	Receiver operating characteristic ( ROC ) curves identified optimal cut-off points ; logistic regression determined ORs .
-RESULTS	After induction with 5mg/kg infliximab , 25 % ( 37/147 ) and 33 % ( 47/144 ) of patients sustained week 14 response to infliximab 5 or 10mg/kg , respectively , administered every 8weeks without dose escalation , through week 54 .
-RESULTS	Median week 14 trough levels of patients with and without durable sustained response to infliximab 5mg/kg were 4.0 and 1.9 g/mL , respectively ( p = 0.0331 ) .
-RESULTS	Optimal predictors of durable sustained response to maintenance infliximab 5mg/kg were week 14 trough level 3.5 g/mL and 60 % CRP decrease ( ORs ( 95 % CI ) , 3.5 ( 1.1 to 11.4 ) and 7.3 ( 1.4 to 36.7 ) ) , respectively , in patients with raised baseline CRP ( > 8.0 mg/L ) ; area under the ROC curve was 0.75 for both predictors .
-RESULTS	A 3.5 g/mL week 14 infliximab serum level did not predict durable sustained response to 10mg/kg maintenance infliximab .
-CONCLUSIONS	Patients with durable sustained response to maintenance infliximab 5mg/kg had higher postinduction trough levels than patients without durable sustained response .
-CONCLUSIONS	Serum infliximab trough levels 3.5 g/mL and 60 % CRP decrease were significantly associated with durable sustained response .
-
-###25248996
-BACKGROUND	Intimate partner violence ( IPV ) and HIV are important and interconnected public health concerns .
-BACKGROUND	While it is recognized that they share common social drivers , there is limited evidence surrounding the potential of community interventions to reduce violence and HIV risk at the community level .
-BACKGROUND	The SASA !
-BACKGROUND	study assessed the community-level impact of SASA !
-BACKGROUND	, a community mobilization intervention to prevent violence and reduce HIV-risk behaviors .
-METHODS	From 2007 to 2012 a pair-matched cluster randomized controlled trial ( CRT ) was conducted in eight communities ( four intervention and four control ) in Kampala , Uganda .
-METHODS	Cross-sectional surveys of a random sample of community members , 18 - to 49-years old , were undertaken at baseline ( n = 1,583 ) and four years post intervention implementation ( n = 2,532 ) .
-METHODS	Six violence and HIV-related primary outcomes were defined a priori .
-METHODS	An adjusted cluster-level intention-to-treat analysis compared outcomes in intervention and control communities at follow-up .
-RESULTS	The intervention was associated with significantly lower social acceptance of IPV among women ( adjusted risk ratio 0.54 , 95 % confidence interval ( CI ) 0.38 to 0.79 ) and lower acceptance among men ( 0.13 , 95 % CI 0.01 to 1.15 ) ; significantly greater acceptance that a woman can refuse sex among women ( 1.28 , 95 % CI 1.07 to 1.52 ) and men ( 1.31 , 95 % CI 1.00 to 1.70 ) ; 52 % lower past year experience of physical IPV among women ( 0.48 , 95 % CI 0.16 to 1.39 ) ; and lower levels of past year experience of sexual IPV ( 0.76 , 95 % CI 0.33 to 1.72 ) .
-RESULTS	Women experiencing violence in intervention communities were more likely to receive supportive community responses .
-RESULTS	Reported past year sexual concurrency by men was significantly lower in intervention compared to control communities ( 0.57 , 95 % CI 0.36 to 0.91 ) .
-CONCLUSIONS	This is the first CRT in sub-Saharan Africa to assess the community impact of a mobilization program on the social acceptability of IPV , the past year prevalence of IPV and levels of sexual concurrency .
-CONCLUSIONS	SASA !
-CONCLUSIONS	achieved important community impacts , and is now being delivered in control communities and replicated in 15 countries .
-BACKGROUND	ClinicalTrials.gov #NCT 00790959 .
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-###26095867
-BACKGROUND	It is uncertain whether bridging anticoagulation is necessary for patients with atrial fibrillation who need an interruption in warfarin treatment for an elective operation or other elective invasive procedure .
-BACKGROUND	We hypothesized that forgoing bridging anticoagulation would be noninferior to bridging with low-molecular-weight heparin for the prevention of perioperative arterial thromboembolism and would be superior to bridging with respect to major bleeding .
-METHODS	We performed a randomized , double-blind , placebo-controlled trial in which , after perioperative interruption of warfarin therapy , patients were randomly assigned to receive bridging anticoagulation therapy with low-molecular-weight heparin ( 100 IU of dalteparin per kilogram of body weight ) or matching placebo administered subcutaneously twice daily , from 3 days before the procedure until 24 hours before the procedure and then for 5 to 10 days after the procedure .
-METHODS	Warfarin treatment was stopped 5 days before the procedure and was resumed within 24 hours after the procedure .
-METHODS	Follow-up of patients continued for 30 days after the procedure .
-METHODS	The primary outcomes were arterial thromboembolism ( stroke , systemic embolism , or transient ischemic attack ) and major bleeding .
-RESULTS	In total , 1884 patients were enrolled , with 950 assigned to receive no bridging therapy and 934 assigned to receive bridging therapy .
-RESULTS	The incidence of arterial thromboembolism was 0.4 % in the no-bridging group and 0.3 % in the bridging group ( risk difference , 0.1 percentage points ; 95 % confidence interval [ CI ] , -0.6 to 0.8 ; P = 0.01 for noninferiority ) .
-RESULTS	The incidence of major bleeding was 1.3 % in the no-bridging group and 3.2 % in the bridging group ( relative risk , 0.41 ; 95 % CI , 0.20 to 0.78 ; P = 0.005 for superiority ) .
-CONCLUSIONS	In patients with atrial fibrillation who had warfarin treatment interrupted for an elective operation or other elective invasive procedure , forgoing bridging anticoagulation was noninferior to perioperative bridging with low-molecular-weight heparin for the prevention of arterial thromboembolism and decreased the risk of major bleeding .
-CONCLUSIONS	( Funded by the National Heart , Lung , and Blood Institute of the National Institutes of Health ; BRIDGE ClinicalTrials.gov number , NCT00786474 . )
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-###25711323
-OBJECTIVE	The Strategic Timing of AntiRetroviral Treatment ( START ) trial has recruited antiretroviral-nave individuals with high CD4 cell counts from all regions of the world .
-OBJECTIVE	We describe the distribution of cardiovascular disease ( CVD ) risk factors , overall and by geographical region , at study baseline .
-METHODS	The distribution of CVD risk factors was assessed and compared by geographical region among START participants who had a baseline electrocardiogram ( n = 4019 ; North America , 11 % ; Europe/Australia/Israel , 36 % ; South America , 26 % ; Asia , 4 % ; Africa , 23 % ; median age 36 years ; 26 % female ) .
-RESULTS	About 58.3 % ( n = 2344 ) of the participants had at least one CVD risk factor and 18.9 % ( n = 761 ) had two or more .
-RESULTS	The most common CVD risk factors were current smoking ( 32 % ) , hypertension ( 19.3 % ) and obesity ( 16.5 % ) .
-RESULTS	There were significant differences in the prevalence of CVD risk factors among geographical regions .
-RESULTS	The prevalence of at least one risk factor across regions was as follows : North America , 70.0 % ; Europe/Australia/Israel , 65.1 % ; South America , 49.4 % ; Asia , 37.0 % ; Africa , 55.8 % ( P-value < 0.001 ) .
-RESULTS	Significant regional differences were also observed when risk factors were used as part of the Framingham and Data Collection on Adverse events of Anti-HIV Drugs ( D : A :D ) risk scores or used to define a favourable risk profile .
-CONCLUSIONS	CVD risk factors are common among START participants , and their distribution varies by geographical region .
-CONCLUSIONS	Better understanding of how and why CVD risk factors develop in people with HIV infection and their geographical distributions could shed light on appropriate strategies for CVD prevention and may inform the interpretation of the results of START , as CVD is expected to be a major fraction of the primary endpoints observed .
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-###24341820
-BACKGROUND	This randomized controlled trial aimed to evaluate whether the serum procalcitonin ( PCT ) level can be utilized to guide the use of antibiotics in the treatment of acute exacerbations of asthma .
-METHODS	A total of 293 consecutive patients with suspected asthma attacks from February 2005 to July 2010 participated in this study .
-METHODS	225 patients completed the study .
-METHODS	Serum PCT levels , and other inflammatory biomarkers of all patients were measured .
-METHODS	In addition to the standard treatment , the control group received antibiotics according to the attending physicians ' discretions , while the patients in the PCT group were treated with antibiotics according to serum PCT concentrations .
-METHODS	Antibiotics usage was strongly discouraged when the PCT concentration was below 0.1 g/L ; discouraged when the PCT concentration was between 0.1 g/L and 0.25 g/L ; or encouraged when the PCT concentration was above 0.25 g/L .
-METHODS	The primary endpoint was the determination of antibiotics usage .
-METHODS	The second endpoints included the diagnostic accuracy of PCT and other laboratory biomarkers the effectiveness of asthma control , secondary ED visits , hospital re-admissions , repeated needs for steroids or dosage increase , needs for antibiotics , WBC count , PCT levels and FEV1 % .
-RESULTS	At baseline , two groups were identical regarding clinical , laboratory and symptom score .
-RESULTS	Probability of the antibiotics usage in the PCT group ( 46.1 % ) was lower than that in the control group ( 74.8 % ) ( 2 = 21.97 , p < 0.001 .
-RESULTS	RR = 0.561 , 95 % CI 0.441-0 .713 ) .
-RESULTS	PCT and IL-6 showed good diagnostic significance for bacterial asthma ( r = 0.705 , p = 0.003 ) .
-RESULTS	The degrees of asthma control in patients were categorized to three levels and were comparable between the two groups at the six weeks follow-up period ( 2 = 1.62 , p = 0.45 ) .
-RESULTS	There were no significant difference regarding other secondary outcomes ( p > 0.05 ) .
-CONCLUSIONS	The serum PCT concentration can be used to effectively determine whether the acute asthma patients have bacterial infections in the respiratory tract , and to guide the use of antibiotics in the treatment of acute asthma exacerbations , which may substantially reduce unnecessary antibiotic use without compromising the therapeutic outcomes .
-BACKGROUND	ICTRP ChiCTR-TRC-12002534 .
-
-###25400162
-OBJECTIVE	The SYMPLICITY HTN-3 randomized , blinded , sham-controlled trial confirmed the safety of renal denervation ( RDN ) , but did not meet its primary efficacy endpoint .
-OBJECTIVE	Prior RDN studies have demonstrated significant and durable reductions in blood pressure .
-OBJECTIVE	This analysis investigated factors that may help explain these disparate results .
-RESULTS	Patients with resistant hypertension were randomized 2 : 1 to RDN ( n = 364 ) or sham ( n = 171 ) .
-RESULTS	The primary endpoint was the difference in office systolic blood pressure ( SBP ) change at 6 months .
-RESULTS	A multivariable analysis identified predictors of SBP change .
-RESULTS	Additional analyses examined the influence of medication changes , results in selected subgroups and procedural factors .
-RESULTS	Between randomization and the 6-month endpoint , 39 % of patients underwent medication changes .
-RESULTS	Predictors of office SBP reduction at 6 months were baseline office SBP 180 mmHg , aldosterone antagonist use , and non-use of vasodilators ; number of ablations was a predictor in the RDN group .
-RESULTS	Non-African-American patients receiving RDN had a significantly greater change in office SBP than those receiving sham ; -15.2 23.5 vs. -8.6 24.8 mmHg , respectively ( P = 0.012 ) .
-RESULTS	Greater reductions in office and ambulatory SBP , and heart rate were observed with a higher number of ablations and energy delivery in a four-quadrant pattern .
-CONCLUSIONS	Post hoc analyses , although derived from limited patient cohorts , reveal several potential confounding factors that may partially explain the unexpected blood pressure responses in both the sham control and RDN groups .
-CONCLUSIONS	These hypothesis-generating data further inform the design of subsequent research to evaluate the potential role of RDN in the treatment of resistant hypertension .
-CONCLUSIONS	CLINICALTRIALS.GOV IDENTIFIER : NCT01418261 .
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-###24424141
-OBJECTIVE	To test the hypothesis that patients with soft tissue changes related to superficial venous insufficiency ( SVI ) have greater benefits from treatment than those with only symptomatic varicose veins .
-BACKGROUND	A commonly held view is that SVI is only a minor ailment , yet randomized clinical trials ( RCTs ) show that treatment improves quality of life ( QoL ) and is cost-effective .
-BACKGROUND	In an effort to curb the treatment costs of this common disorder , rationing is applied in many health care systems , often limiting the reimbursement of treatment to those with soft tissue changes .
-METHODS	This cohort study draws its data from an interventional RCT .
-METHODS	After informed consent , consecutive patients with symptomatic unilateral SVI were randomized to receive surgical ligation and stripping or endovenous laser ablation .
-METHODS	This analysis differentially studies the outcomes of patients with simple varicose veins ( C2 : n = 191 ) and soft tissue complications ( C3-4 : n = 76 ) .
-METHODS	Effectiveness outcomes measured up to 1 year included the following : Qol [ short form 36 ( SF36 ) , EuroQol , and the Aberdeen Varicose Veins Questionnaire ] , clinical recurrence , and the need for secondary procedures .
-METHODS	Multivariable regression analysis was used to control for potential confounding factors .
-RESULTS	Both groups saw significant improvements in QoL .
-RESULTS	All improvements were equal between groups apart from the SF36 domain of Bodily Pain , where C2 saw an improvement of 12.8 [ 95 % confidence interval ( CI ) : 4.8-20 .8 ] points over C3-4 participants ( P = 0.002 ) , who also suffered more recurrence [ odds ratio ( OR ) = 2.7 , 95 % CI : 1.2-6 .1 , P = 0.022 ] and required more secondary procedures ( OR = 4.4 , 95 % CI : 1.2-16 .3 , P = 0.028 ) .
-CONCLUSIONS	This study suggests that rationing by clinical severity contradicts the evidence .
-CONCLUSIONS	Delaying treatment until the development of skin damage leads to a degree of irreversible morbidity and greater recurrence .
-BACKGROUND	NCT00759434 Clinicaltrials.gov .
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-###25867906
-OBJECTIVE	To determine whether addition of an electronic sepsis evaluation and management tool to electronic sepsis alerting improves compliance with treatment guidelines and clinical outcomes in septic ICU patients .
-METHODS	A pragmatic randomized trial .
-METHODS	Medical and surgical ICUs of an academic , tertiary care medical center .
-METHODS	Four hundred and seven patients admitted during a 4-month period to the medical or surgical ICU with a diagnosis of sepsis established at the time of admission or in response to an electronic sepsis alert .
-METHODS	Patients were randomized to usual care or the availability of an electronic tool capable of importing , synthesizing , and displaying sepsis-related data from the medical record , using logic rules to offer individualized evaluations of sepsis severity and response to therapy , informing users about evidence-based guidelines , and facilitating rapid order entry .
-RESULTS	There was no difference between the electronic tool ( 218 patients ) and usual care ( 189 patients ) with regard to the primary outcome of time to completion of all indicated Surviving Sepsis Campaign 6-hour Sepsis Resuscitation Bundle elements ( hazard ratio , 1.98 ; 95 % CI , 0.75-5 .20 ; p = 0.159 ) or time to completion of each element individually .
-RESULTS	ICU mortality , ICU-free days , and ventilator-free days did not differ between intervention and control .
-RESULTS	Providers used the tool to enter orders in only 28 % of available cases .
-CONCLUSIONS	A comprehensive electronic sepsis evaluation and management tool is feasible and safe but did not influence guideline compliance or clinical outcomes , perhaps due to low utilization .
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-###24406033
-BACKGROUND	Colorectal cancer is a major public health problem .
-BACKGROUND	There is growing support for colorectal cancer survivors who are experiencing problems after cancer treatment to engage in self-management programs to reduce symptom distress .
-BACKGROUND	However , there is inconclusive evidence as to the effectiveness of such program especially in Asian region .
-OBJECTIVE	This study tested the effects of a six-month nurse-led self-efficacy-enhancing intervention for patients with colorectal cancer , compared with routine care over a six-month follow up .
-METHODS	A randomized controlled trial with repeated measures , two-group design .
-METHODS	Three teaching hospitals in Guangzhou , China .
-METHODS	One hundred and fifty-two Chinese adult patients with a diagnosis of colorectal cancer were recruited .
-METHODS	The intervention group ( n = 76 ) received self-efficacy-enhancing intervention and the control group ( n = 76 ) received standard care .
-METHODS	The participants were randomized into either intervention or control group after baseline measures .
-METHODS	The outcomes of the study ( self-efficacy , symptom distress , anxiety , depression and quality of life ) were compared at baseline , three and six months after the intervention .
-RESULTS	Sixty-eight participants in the intervention group and 53 in the control group completed the study .
-RESULTS	Their mean age was 53 ( SD = 11.3 ) .
-RESULTS	Repeated measure MANOVA found that the patients in the intervention group had significant improvement in their self-efficacy ( F = 7.26 , p = 0.003 ) and a reduction of symptom severity ( F = 5.30 , p = 0.01 ) , symptom interference ( F = 4.06 , p = 0.025 ) , anxiety ( F = 6.04 , p = 0.006 ) and depression ( F = 6.96 , p = 0.003 ) at three and six months , compared with the control group .
-RESULTS	However , no statistically significant main effect was observed in quality of life perception between the two groups .
-CONCLUSIONS	The nurse-led self-efficacy enhancing intervention was effective in promoting self-efficacy and psychological well-being in patients with colorectal cancer , compared with standard care .
-CONCLUSIONS	The intervention can be incorporated into routine care .
-CONCLUSIONS	Future empirical work is required to determine the longer term effects of the intervention .
-
-###25491026
-BACKGROUND	Studies that have examined the impact of a physical activity intervention on cardiometabolic risk factors have yielded conflicting results .
-BACKGROUND	The objective of this study was to assess the impact of a standardized physical activity program on adiposity and cardiometabolic risk factors in schoolchildren .
-METHODS	Cluster randomized trial study of 712 schoolchildren , 8-10 years , from 20 public schools in the Province of Cuenca , Spain .
-METHODS	The intervention ( MOVI-2 ) consisted of play-based and non-competitive activities .
-METHODS	MOVI-2 was conducted during two 90-minute sessions on weekdays and one 150-minute session on Saturday mornings every week between September 2010 and May 2011 .
-METHODS	We measured changes in adiposity ( overweight/obesity prevalence , body mass index [ BMI ] , triceps skinfold thickness [ TST ] , body fat % , fat-free mass , waist circumference ) and other cardiometabolic risk factors ( LDL-cholesterol , triglycerides/HDL-cholesterol ratio , insulin , C-reactive protein and blood pressure ) .
-METHODS	The analyses used mixed regression models to adjust for baseline covariates under cluster randomization .
-RESULTS	Among girls , we found a reduction of adiposity in intervention versus control schools , with a decrease in TST ( -1.1 mm ; 95 % confidence interval [ CI ] -2.3 to -0.7 ) , body fat % ( -0.9 % ; 95 % CI -1.3 to -0.4 ) , waist circumference ( -2.7 cm ; 95 % CI -4.5 to -0.9 ) , and an increase in fat-free mass ( 0.3 kg ; 95 % CI 0.01 to 0.6 ) .
-RESULTS	The intervention also led to lower serum LDL-cholesterol and insulin levels .
-RESULTS	Among boys , a reduction in waist circumference ( -1.4 cm ; 95 % CI -2.6 to -0.1 ; P = 0.03 ) , and an increase in fat-free mass ( 0.5 kg ; 95 % CI 0.2 to 0.9 ; P = 0.003 ) was associated with the intervention versus control schools .
-RESULTS	The prevalence of overweight/obesity or underweight , BMI , and other cardiometabolic risk factors was not modified by the intervention .
-RESULTS	No important adverse events were registered .
-CONCLUSIONS	An extracurricular intervention of non-competitive physical activity during an academic year , targeting all schoolchildren regardless of body weight , is a safe and effective measure to reduce adiposity in both genders and to improve cardiometabolic risk profile in girls .
-BACKGROUND	Clinical trials NCT01277224 .
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-###24220935
-OBJECTIVE	We investigated potential biomarkers of efficacy in a phase III trial of sunitinib versus interferon-alpha ( IFN - ) , first-line in metastatic renal cell carcinoma ( mRCC ) , by analyzing plasma levels of vascular endothelial growth factor ( VEGF ) - A , VEGF-C , soluble VEGF receptor-3 ( sVEGFR-3 ) and interleukin ( IL ) -8 .
-METHODS	Seven hundred and fifty mRCC patients were randomized to oral sunitinib 50 mg/day in repeated cycles of a 4-week on/2-week off schedule or IFN - 9 million units subcutaneously thrice weekly .
-METHODS	Plasma samples collected from a subset of 63 patients on days 1 and 28 of cycles 1-4 and at end of treatment were analyzed by ELISA .
-RESULTS	Baseline characteristics of biomarker-evaluated patients in sunitinib ( N = 33 ) and IFN - ( N = 30 ) arms were comparable to their respective intent-to-treat populations .
-RESULTS	By univariate Cox regression analysis , low baseline soluble protein levels were associated with lower risk of progression/death ( all P < 0.05 ) : in both treatment arms , baseline VEGF-A and IL-8 were associated with overall survival ( OS ) and baseline VEGF-C with progression-free survival ( PFS ) ; in the sunitinib arm , baseline VEGF-A was associated with PFS and baseline sVEGFR-3 with PFS and OS ; in the IFN - arm , baseline IL-8 was associated with PFS .
-RESULTS	In multivariate analysis , baseline sVEGFR-3 and IL-8 remained independent predictors of OS in the sunitinib arm , while no independent predictors of outcome remained in the IFN - arm .
-RESULTS	Pharmacodynamic changes were not associated with PFS or OS for any plasma protein investigated .
-CONCLUSIONS	Our findings suggest that , in mRCC , baseline VEGF-A and IL-8 may have prognostic value , while baseline sVEGFR-3 may predict sunitinib efficacy .
-
-###24231639
-OBJECTIVE	The aim of the study was to evaluate the relation between nutritional intake ( kilocalories , protein ) and weight and length growth in preterm infants , and to describe their metabolic tolerance with a focus on those with high protein intake ( 4.6 g kg ( -1 ) day ( -1 ) ) .
-METHODS	Secondary analysis of data from appropriate-for-gestational age preterm infants in a 28-day randomized clinical trial that evaluated growth , tolerance , and safety of a new ultraconcentrated liquid human milk fortifier ( original study n = 150 ) .
-METHODS	This subset of 56 infants had complete growth and nutrition data and met criteria for the original study 's `` efficacy analysis '' ( eg , > 80 % of kilocalorie intake from study diet ) .
-METHODS	Nutritional intake was estimated , not actual .
-METHODS	Regressions were used to test cumulative kilocalories and protein as the predictors of 28-day change in weight and length z scores ( growth status ) , and to evaluate protein tolerance .
-RESULTS	Average intake was 118 8 kcal kg ( -1 ) day ( -1 ) and 4.3 0.4 g protein kg ( -1 ) day ( -1 ) , with 16 3 g kg ( -1 ) day ( -1 ) and 1.1 0.2 cm/week growth for 28 days .
-RESULTS	Cumulative total kilocalories and protein were significant predictors of improved length z score ( P = 0.0054 , 0.0005 ) but not weight z score change .
-RESULTS	Regression models indicated that protein not kilocalories explained the improvement in length z score , with protein explaining 19 % of the variability .
-RESULTS	The high protein group averaged 4.6 to 5.5 g kg ( -1 ) day ( -1 ) ( n = 16 ) .
-RESULTS	Protein tolerance was adequate for all of the study infants based on metabolic measures ( blood urea nitrogen , serum carbon dioxide , pH ) .
-CONCLUSIONS	Higher cumulative protein intake was tolerated and overall lessened the commonly occurring decline in the length but not weight growth status in a 28-day study of preterm infants .
-
-###24247211
-OBJECTIVE	The objective of this study was to investigate whether ingestion of fructose and fructans ( such as inulin ) can exacerbate irritable bowel syndrome ( IBS ) symptoms .
-OBJECTIVE	The aim was to better understand the origin of these symptoms by magnetic resonance imaging ( MRI ) of the gut .
-METHODS	A total of 16 healthy volunteers participated in a four-way , randomized , single-blind , crossover study in which they consumed 500ml of water containing 40g of either glucose , fructose , inulin , or a 1:1 mixture of 40g glucose and 40g fructose .
-METHODS	MRI scans were performed hourly for 5h , assessing the volume of gastric contents , small bowel water content ( SBWC ) , and colonic gas .
-METHODS	Breath hydrogen ( H2 ) was measured and symptoms recorded after each scan .
-RESULTS	Data are reported as mean ( s.d. ) ( 95 % CI ) when normally distributed and median ( range ) when not .
-RESULTS	Fructose increased area under the curve ( AUC ) from 0-5h of SBWC to 71 ( 23 ) l/min , significantly greater than for glucose at 36 ( 11-132 ) l/min ( P < 0.001 ) , whereas AUC SBWC after inulin , 33 ( 17-106 ) l/min , was no different from that after glucose .
-RESULTS	Adding glucose to fructose decreased AUC SBWC to 55 ( 28 ) l/min ( P = 0.08 ) vs. fructose .
-RESULTS	Inulin substantially increased AUC colonic gas to 33 ( 20 ) l/min , significantly greater than glucose and glucose + fructose ( both P < 0.05 ) .
-RESULTS	Breath H2 rose more with inulin than with fructose .
-RESULTS	Glucose when combined with fructose significantly reduced breath H2 by 7,700 ( 3,121-12 ,300 ) p.p.m. / min relative to fructose alone ( P < 0.01 , n = 13 ) .
-CONCLUSIONS	Fructose but not inulin distends the small bowel with water .
-CONCLUSIONS	Adding glucose to fructose reduces the effect of fructose on SBWC and breath hydrogen .
-CONCLUSIONS	Inulin distends the colon with gas more than fructose , but causes few symptoms in healthy volunteers .
-
-###25488963
-OBJECTIVE	This open-label phase III trial evaluated efficacy and tolerability of linifanib versus sorafenib in patients with advanced hepatocellular carcinoma ( HCC ) without prior systemic therapy .
-METHODS	Patients were randomly assigned in a 1:1 ratio to linifanib 17.5 mg once daily or sorafenib 400 mg twice daily .
-METHODS	Patients were stratified by region ( Outside Asia , Japan , and rest of Asia ) , Eastern Cooperative Oncology Group performance score ( ECOG PS ; 0 or 1 ) , vascular invasion or extrahepatic spread ( yes or no ) , and hepatitis B virus ( HBV ) infection ( yes or no ) .
-METHODS	The primary end point of the study was overall survival ( OS ) .
-METHODS	Secondary end points were time to progression ( TTP ) and objective response rate ( ORR ) per RECIST v1 .1 .
-RESULTS	We randomly assigned 1,035 patients ( median age , 60 years ; Asian , 66.6 % ; ECOG PS 0 , 65.2 % ; HBV , 49.1 % ; vascular invasion or extrahepatic spread , 70.1 % ) .
-RESULTS	Median OS was 9.1 months on the linifanib arm ( 95 % CI , 8.1 to 10.2 ) and 9.8 months on the sorafenib arm ( 95 % CI , 8.3 to 11.0 ; hazard ratio [ HR ] , 1.046 ; 95 % CI , 0.896 to 1.221 ) .
-RESULTS	For prespecified stratification subgroups , OS HRs ranged from 0.793 to 1.119 and the 95 % CI contained 1.0 .
-RESULTS	Median TTP was 5.4 months on the linifanib arm ( 95 % CI , 4.2 to 5.6 ) and 4.0 months on the sorafenib arm ( 95 % CI , 2.8 to 4.2 ; HR , 0.759 ; 95 % CI , 0.643 to 0.895 ; P = .001 ) .
-RESULTS	Best response rate was 13.0 % on the linifanib arm versus 6.9 % on the sorafenib arm .
-RESULTS	Grade 3/4 adverse events ( AEs ) ; serious AEs ; and AEs leading to discontinuation , dose interruption , and reduction were more frequent with linifanib ( all P < .001 ) .
-CONCLUSIONS	Linifanib and sorafenib had similar OS in advanced HCC .
-CONCLUSIONS	Predefined superiority and noninferiority OS boundaries were not met for linifanib and the study failed to meet the primary end point .
-CONCLUSIONS	TTP and ORR favored linifanib ; safety results favored sorafenib .
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-###24443804
-BACKGROUND	While many of the commonly used conservative treatments for knee osteoarthritis ( OA ) have been recognized to be effective , there is still insufficient evidence available .
-BACKGROUND	Among the pharmacological treatments for knee OA , oral non-steroidal anti-inflammatory drugs ( NSAIDs ) act rapidly and are recommended for the management of OA .
-BACKGROUND	However , frequent and serious adverse effects of NSAIDs have been recognized .
-BACKGROUND	Intra-articular injections of hyaluronic acid ( IA-HA ) for the treatment of knee OA have been shown to reduce pain and improve joint function .
-BACKGROUND	However , there has been no qualified direct comparison study of the efficacy and safety between IA-HA and NSAIDs for patients with knee OA .
-BACKGROUND	The aim of this study was to clarify the efficacy and safety of early-phase IA-HA in comparison to those of NSAIDs for patients with knee OA .
-METHODS	This multicenter , randomized , open-label , parallel-group , non-inferiority comparison study with an oral NSAID involved a total of 200 patients with knee OA .
-METHODS	An independent , computer-generated randomization sequence was used to randomly assign patients in a 1:1 ratio to NSAIDs three times per day for five weeks ( n = 100 ) or IA-HA once a week for five weeks ( n = 100 ) .
-METHODS	The primary endpoint was the percentage change in the patient-oriented outcome measure for knee OA , the Japanese Knee Osteoarthritis Measure ( JKOM ) score .
-METHODS	All patients were questioned regarding any adverse events during treatment .
-METHODS	The full analysis set ( FAS ) was used for analysis .
-METHODS	The margin of non-inferiority was 10 % .
-RESULTS	The analyses of primary endpoint included 98 patients in the IA-HA group and 86 patients in the NSAID group .
-RESULTS	The difference in the percentage changes of the JKOM score between the two intervention arms ( IA-HA ; -34.7 % ( P < 0.001 ) , NSAID ; -32.2 % ( P < 0.001 ) ) was -2.5 % ( 95 % confidence interval ( CI ) : -14.0 to 9.1 ) , indicating IA-HA was not inferior to NSAID .
-RESULTS	The frequency of both withdrawal and adverse events in the IA-HA group were significantly lower than those in the NSAID group ( P = 0.026 and 0.004 , respectively ) .
-CONCLUSIONS	The early efficacy of IA-HA is suggested to be not inferior to that of NSAIDs , and that the safety of the early phase of IA-HA is superior to that of NSAIDs for patients with knee OA .
-BACKGROUND	UMIN Clinical Trials Registry ( UMIN-CTR ) , UMIN000001026 .
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-###25160734
-BACKGROUND	Two randomized intraoperative radiation therapy trials for early-stage breast cancer were recently published .
-BACKGROUND	The ELIOT Trial used electrons ( IOERT ) , and the TARGIT-A Trial Update used 50-kV X-rays ( IORT ) .
-BACKGROUND	These studies were compared for similarities and differences .
-BACKGROUND	The results were analyzed and used to determine which patients might be suitable for single-dose treatment .
-METHODS	The primary sources of data were the ELIOT Trial and TARGIT-A Trial , as well as a comprehensive analysis of the peer-reviewed literature of accelerated partial breast irradiation ( APBI ) using 50-kV X-rays or electrons .
-METHODS	Studies published or presented prior to March 2014 were analyzed for efficacy , patient restrictions , complications , and outcome .
-RESULTS	With a median follow-up of 5.8 years , the 5-year recurrence rates for ELIOT versus external beam radiation therapy ( EBRT ) patients were 4.4 % and 0.4 % , respectively , p = .0001 .
-RESULTS	A low-risk ELIOT group was identified with a 5-year recurrence rate of 1.5 % .
-RESULTS	With a median follow-up of 29months , the 5-year recurrence rates for the TARGIT-A versus EBRT patients were 3.3 % and 1.3 % , respectively , p = .042 .
-CONCLUSIONS	With 5.8 years of median follow-up , IOERT appears to have a subset of low-risk women for whom IOERT is acceptable .
-CONCLUSIONS	With 29months of median follow-up the results of IORT with 50-kV devices are promising , but longer follow-up data are required .
-CONCLUSIONS	At the current time , single-fraction IOERT or IORT patients should be treated under strict institutional protocols .
-
-###24369008
-OBJECTIVE	To examine whether baseline obesity severity modifies the effects of two different , primary care-based , technology-enhanced lifestyle interventions among overweight or obese adults with prediabetes and/or metabolic syndrome .
-METHODS	We compared mean differences in changes from baseline to 15 months in clinical measures of general and central obesity among participants randomized to usual care alone ( n = 81 ) or usual care plus a coach-led group ( n = 79 ) or self-directed individual ( n = 81 ) intervention , stratified by baseline body mass index ( BMI ) category .
-RESULTS	Participants with baseline BMI 35 + had greater reductions in mean BMI , body weight ( as percentage change ) , and waist circumference in the coach-led group intervention , compared to usual care and the self-directed individual intervention ( P < 0.05 for all ) .
-RESULTS	In contrast , the self-directed intervention was more effective than usual care only among participants with baseline BMIs between 25 35 .
-RESULTS	Mean weight loss exceeded 5 % in the coach-led intervention regardless of baseline BMI category , but this was achieved only among self-directed intervention participants with baseline BMIs < 35 .
-CONCLUSIONS	Baseline BMI may influence behavioral weight-loss treatment effectiveness .
-CONCLUSIONS	Researchers and clinicians should take an individual 's baseline BMI into account when developing or recommending lifestyle focused treatment strategy .
-CONCLUSIONS	This trial is registered with ClinicalTrials.gov NCT00842426 .
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-###25326007
-BACKGROUND	Patients ' reported opinions of the health system need to be understood in order to provide patient-centered care .
-BACKGROUND	We investigated determinants of women 's ratings of the quality of care during their most recent facility delivery .
-METHODS	We conducted a census of all deliveries in the 6 weeks to 12 months preceding the survey , in villages served by 24 primary care clinics in rural Pwani Region , Tanzania .
-METHODS	Women who had delivered children in a study facility were included in this analysis ( n = 855 ) .
-METHODS	We interviewed women about demographic and obstetric factors and the quality of their obstetric care using a structured questionnaire .
-METHODS	We created a composite index of perceived quality from six quality questions .
-METHODS	We also assessed the functioning of the local health clinic using structured surveys .
-METHODS	We used a multi-level model to analyze factors associated with women 's rating of the quality of care during delivery .
-RESULTS	14 % of respondents rated the overall quality of care received during delivery as excellent .
-RESULTS	Women who listened to the radio daily reported lower quality composite scores ( : -0.99 , p < 0.001 ) .
-RESULTS	Women who reported receiving more services in ANC had higher quality scores ( : 0.46 , p = 0.001 ) , as did women receiving more delivery services ( : 0.55 , p < 0.001 ) .
-RESULTS	Women who reported disrespect and abuse during delivery had significantly lower quality scores ( : -4.13 , p < 0.001 ) .
-CONCLUSIONS	A woman 's expectations and prior and current experiences influence her perception of the quality of care she received .
-CONCLUSIONS	Health facility characteristics did not influence ratings of overall quality .
-CONCLUSIONS	Focusing on improving the process rather than inputs of service delivery during ANC visits and delivery may increase perceived quality of delivery care in low-resource settings .
-BACKGROUND	ISRCTN17107760 .
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-###25391382
-BACKGROUND	There is a lack of knowledge about antidementia drug treatment in community dwelling people with dementia in Germany .
-OBJECTIVE	To determine the frequency of treatment with antidementia drugs in patients in primary care , and the socio-demographic and clinical variables associated with antidementia drug treatment .
-METHODS	Present analyses are based on preliminary data from the DelpHi-trial , an ongoing GP-based , cluster-randomized , controlled intervention trial to implement and evaluate an innovative concept of collaborative dementia care management in Germany .
-METHODS	Our sample consists of n = 243 subjects who screened positive for dementia .
-RESULTS	29.6 % ( n = 72 ) of participants received antidementia drugs : memantine 44.5 % ( n = 32 ) ; donepezil 30.5 % ( n = 22 ) ; rivastigmine 13.9 % ( n = 10 ) ; galantamine 11.1 % ( n = 8 ) .
-RESULTS	A total of 46.4 % ( n = 45 ) of the subgroup of participants with a formal dementia diagnosis received antidementia drug treatment .
-RESULTS	Approximately 37.5 % ( n = 27 ) of our sample received treatment with antidementia drugs without having a formal diagnosis .
-RESULTS	Treatment with antidementia drugs was significantly associated with more severe cognitive impairment and having a formal dementia diagnosis .
-CONCLUSIONS	One in three people who screened positive for dementia in primary care received antidementia drug treatment , indicating the frequent use of this class of drugs .
-CONCLUSIONS	For those with a formal dementia diagnosis , these drug treatment rates are more than triple , compared to those in nursing homes .
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-###24767009
-BACKGROUND	Internet-delivered trauma-focused cognitive behavioural therapy is efficacious for PTSD ; however , no studies have investigated the roles of individual treatment components or the safety of online treatments .
-OBJECTIVE	To compare the efficacy and safety of an online treatment for PTSD comprised of psychoeducation , stress management , cognitive restructuring and exposure components with the equivalent protocol without the exposure components , using a randomised controlled trial design .
-METHODS	Sixty-six individuals were randomised to a non-exposure condition and 59 to the full protocol with exposure components .
-METHODS	Treatment duration was 8 weeks and pre - , post-treatment and three-month follow-up outcomes were analysed using a mixed linear modelling approach .
-RESULTS	Both groups achieved improvements in symptoms with no differences between groups on any primary or secondary outcome measures , diagnostic remission rates or adverse events .
-CONCLUSIONS	The study included several secondary measures that have not been previously validated and treatments were not time matched in terms of number of lessons .
-CONCLUSIONS	These findings indicate that trauma-focused cognitive behavioural therapy for PTSD with or without exposure components can be safe and efficacious .
-
-###24291239
-OBJECTIVE	Patients with genotype 3 hepatitis C virus ( HCV ) infection and cirrhosis have poor response rates after 24 weeks treatment with pegylated interferon and ribavirin .
-OBJECTIVE	Treatment for 48 weeks is therefore recommended , although the benefits of this are untested .
-OBJECTIVE	We examined extended therapy in patients with genotype 3 HCV and advanced fibrosis .
-METHODS	Multicentre , open labelled randomized trial comparing therapy with 24 weeks pegylated interferon and ribavirin to 48 weeks of the same therapy .
-RESULTS	136 patients completed the study .
-RESULTS	67 received 24 weeks therapy and the SVR rate ( 48 % ) did not differ from that seen in the 69 patients who received 48 weeks therapy ( 42 % ) .
-RESULTS	The response rates in patients with biopsy proven cirrhosis ( 13 patients treated for 24 weeks , 18 patients treated for 48 weeks ) or cirrhosis proven on imaging ( 28 patients treated for 24 weeks and 25 patients treated for 48 weeks ) were 46 % in those treated for 24 weeks and 40 % in those treated for 48 weeks .
-RESULTS	The differences were not significantly different .
-RESULTS	Treatment failure was due to relapse in the majority of patients .
-CONCLUSIONS	Patients with genotype 3 HCV and advanced fibrosis do not benefit from extended therapy with pegylated interferon and ribavirin .
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-###24689967
-OBJECTIVE	Epidemiological research links aggression to low serum concentrations of omega-3 fatty acids , such as those found in fish oil .
-OBJECTIVE	However , no studies have specifically examined whether fish oil supplementation can reduce the frequency and severity of impulsive aggression in children with disruptive behavior disorders .
-METHODS	Children presenting with impulsive aggression and meeting research criteria for diagnosis of disruptive behavior disorders were randomized to receive either : 1 ) Fish oil capsules ( 4g daily ) for 6 weeks followed by placebo ( identical-looking capsules ) for 6 weeks ; or 2 ) placebo for 6 weeks , followed by fish oil for 6 weeks , in a double-blind , crossover design .
-METHODS	Primary outcomes were the Children 's Aggression Scale and the Modified Overt Aggression Scale .
-METHODS	Secondary outcomes included emotional and behavioral functioning ( Strengths and Difficulties Questionnaire [ SDQ ] ) , hyperactivity symptoms ( Attention-Deficit/Hyperactivity Disorder [ ADHD ] Rating Scale ) , family functioning ( Family Assessment Device ) , and cognitive functioning ( Stop Signal Task , Trail-Making Task , and Eriksen Flanker Task ) .
-METHODS	Serum concentrations of omega-3 and omega-6 fatty acids were measured at baseline , and at 6 and 12 weeks .
-RESULTS	Twenty-one children participated ( 81 % male ; mean age 10.32.2 years ; range 7-14 ) .
-RESULTS	Fish oil treatment increased serum concentrations of eicosapentanoic acid ( F = 14.76 , p < 0.05 ) and total omega-3s ( F = 20.56 , p < 0.05 ) , but did not influence primary ratings of aggression .
-RESULTS	In fact , a trend suggested that fish oil worsened a secondary measure of aggression ( SDQ Conduct Subscale , F = 4.34 , p = 0.06 ) .
-RESULTS	Fish oil treatment was associated with an improvement in one rating of hyperactivity ( SDQ Hyperactivity Subscale , F = 2.22 , p < 0.05 ) , but did not influence any other outcome measures .
-CONCLUSIONS	These findings suggest that fish oil treatment does not improve aggression in children with disruptive behavior disorders .
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-###25486542
-OBJECTIVE	To compare outcomes of illuminated microcatheter-assisted circumferential trabeculotomy vs combined mitomycin C-augmented trabeculotomy-trabeculectomy for primary congenital glaucoma .
-METHODS	Prospective , randomized trial .
-METHODS	Of the 30 patients ( 60 eyes ) analyzed with bilateral primary congenital glaucoma aged 2 years , 1 eye of each patient was randomized to : illuminated microcatheter-assisted trabeculotomy ( Group I ) or combined trabeculotomy with trabeculectomy augmented with mitomycin C ( Group II ) .
-METHODS	Primary outcome measure was intraocular pressure ( IOP ) reduction .
-METHODS	Categorization into absolute success ( IOP 15mm Hg without medication ) and qualified success ( IOP 15mm Hg with medication ) was done .
-METHODS	Secondary outcomes included change in corneal diameter and clarity , optic disc status , refraction , need for anti-glaucoma therapy , and occurrence of complications .
-RESULTS	Mean age of patients was 6.63 5.74 months .
-RESULTS	IOP fell by 49.3 % ( 22.25 10.88 to 11.56 3.33 mm Hg ) in Group I and 46.6 % in Group II ( 21.73 8.89 to 11.60 3.03 mm Hg ) ( P < .001 in both ) .
-RESULTS	At 1 year , absolute success was achieved in 86.7 % ( 26/30 ) and 90.0 % ( 27/30 ) in Groups I and II , respectively ( P > .99 ) and qualified success in 93.3 % ( 28/30 ) in both groups ( P = 1 ) .
-RESULTS	There was significant improvement in corneal clarity ( P < .001 ) and cup-to-disc ratio ( P .01 ) in both groups at 1 year .
-RESULTS	Though incidence of hyphema was significantly more in Group I ( P = .0001 ) , no vision-threatening complications occurred in either group .
-CONCLUSIONS	Illuminated microcatheter-assisted circumferential trabeculotomy achieved comparable surgical outcomes to mitomycin C-augmented combined trabeculotomy-trabeculectomy and may be recommended as the initial surgical procedure for primary congenital glaucoma .
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-###25403717
-BACKGROUND	Non-attenders for cervical screening are at increased risk of cervical cancer .
-BACKGROUND	Studies offering self-sampling for high-risk Human Papillomavirus ( HrHPV ) testing have shown greater uptake than sending another invitation for cytology .
-OBJECTIVE	To explore whether uptake would increase in a less diverse , more stable population than the previous English study , which demonstrated a lower response rate than other studies .
-OBJECTIVE	The primary objective was whether non-attenders were more likely to respond to a postal invitation , including kit , to collect a self-sample compared with a further invitation for cytology screening .
-OBJECTIVE	The secondary objective was whether women with an abnormal result would attend for follow-up .
-METHODS	6000 non-attenders for screening in this pragmatic , randomized ( 1:1 ) controlled trial in Newcastle-upon-Tyne were sent an HPV self-sample kit ( intervention ) or a further invitation for cytology screening ( comparator ) .
-RESULTS	411 ( 13 % ) responded to the intervention , returning a self-sample ( 247 ( 8 % ) ) or attending for cytology ( 164 ( 5 % ) ) , compared with 183 ( 6 % ) attending for cytology , relative risk 2.25 ( 95 % CI 1.90-2 .65 ) ( comparator arm ) .
-RESULTS	Of those testing hrHPV positive ( 32 ( 13 % ) ) , 19 ( 59 % ) subsequently attended cytology screening .
-RESULTS	Of those in the intervention group who attended for cytology screening without returning an hrHPV self-sample ( n = 164 ) , 5 % ( n = 8 ) were referred for colposcopy-all attended .
-RESULTS	In the comparator group eight of the nine referred for colposcopy attended .
-CONCLUSIONS	Persistent non-responders to invitations for cervical screening are significantly more likely to respond to a postal invitation to return a self-collected sample for HPV testing than a further invitation for cytology screening .
-CONCLUSIONS	However , just over half followed up on this positive HPV result .
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-###24418670
-OBJECTIVE	To examine how the location where reading takes place and the availability of prior images can affect performance in breast test-set reading .
-METHODS	Under optimized viewing conditions , 10 expert screen readers each interpreted a reader-specific set of images containing 200 mammographic cases .
-METHODS	Readers , randomly divided into two groups read images under one of two pairs of conditions : clinical read with prior images and laboratory read with prior images ; laboratory read with prior images and laboratory read without prior images .
-METHODS	Region-of-interest ( ROI ) figure-of-merit ( FOM ) was analysed using JAFROC software .
-METHODS	Breast side-specific sensitivity and specificity were tested using Wilcoxon matched-pairs signed rank tests .
-METHODS	Agreement between pairs of readings was measured using Kendall 's coefficient of concordance .
-RESULTS	Group performances between test-set readings demonstrated similar ROI FOMs , sensitivity and specificity median values , and acceptable levels of agreement between pairs of readings were shown ( W = 0.75-0 .79 , p < 0.001 ) for both pairs of reading conditions .
-RESULTS	On an individual reader level , two readers demonstrated significant decreases ( p < 0.05 ) in ROI FOMs when prior images were unavailable .
-RESULTS	Reading location had an inconsistent impact on individual performance .
-CONCLUSIONS	Reading location and availability of prior images did not significantly alter group performance .
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-###25575599
-BACKGROUND	Effective strategies for contacting and recruiting study participants are critical in conducting clinical research .
-BACKGROUND	In this study , we conducted two sequential randomized controlled trials of mail - and telephone-based strategies for contacting and recruiting participants , and evaluated participant-related variables ' association with time to survey completion and survey completion rates .
-BACKGROUND	Subjects eligible for this study were survivors of acute lung injury who had been previously enrolled in a 12-month observational follow-up study evaluating their physical , cognitive and mental health outcomes , with their last study visit completed at a median of 34 months previously .
-METHODS	Eligible subjects were contacted to complete a new research survey as part of two randomized trials , initially using a randomized mail-based contact strategy , followed by a randomized telephone-based contact strategy for non-responders to the mail strategy .
-METHODS	Both strategies focused on using either a personalized versus a generic approach .
-METHODS	In addition , 18 potentially relevant subject-related variables ( e.g. , demographics , last known physical and mental health status ) were evaluated for association with time to survey completion .
-RESULTS	Of 308 eligible subjects , 67 % completed the survey with a median ( IQR ) of 3 ( 2 , 5 ) contact attempts required .
-RESULTS	There was no significant difference in the time to survey completion for either randomized trial of mail - or phone-based contact strategy .
-RESULTS	Among all subject-related variables , age 40 years and minority race were independently associated with a longer time to survey completion .
-CONCLUSIONS	We found that age 40 years and minority race were associated with a longer time to survey completion , but personalized versus generic approaches to mail - and telephone-based contact strategies had no significant effect .
-CONCLUSIONS	Repeating both mail and telephone contact attempts was important for increasing survey completion rate .
-BACKGROUND	NCT00719446 .
-
-###24717710
-OBJECTIVE	The purpose of this study was to compare the pain rating scale measurements from an exposure group ( injections with the aid of DentalVibe Injection Comfort System ) and control group ( traditional injection without the aid of the DentalVibe ) in adolescent patients using self-reported pain during administration of local anesthetic injections .
-METHODS	This was a randomized , controlled study .
-METHODS	Subjects consisted of 36 10 - to 17-year-old patients who required local anesthesia for dental treatment on both sides of the maxilla or mandible .
-METHODS	All subjects received a conventional injection ( control ) and an injection using DentalVibe ( experimental ) .
-METHODS	A pain rating for each injection was obtained from subjects using the Wong-Baker FACES Pain Rating Scale .
-RESULTS	Statistical analysis using a Wilcoxon signed rank test found a significant reduction in pain ratings for injections with the DentalVibe when compared to control injections .
-RESULTS	There was a positive correlation between the pain rating for control injection and the difference between the two types of injection , indicating that subjects who reported a higher pain score with the control injection had a greater reduction when DentalVibe was used .
-CONCLUSIONS	When compared to a conventional approach , DentalVibe significantly lowered self-reported pain during local anesthesia injection for adolescent subjects in this study .
-
-###25741642
-BACKGROUND	Recent recommendations for lung protective mechanical ventilation include a tidal volume target of 6 mL/kg predicted body weight ( PBW ) .
-BACKGROUND	Different PBW equations might introduce important differences in tidal volumes delivered to research subjects and patients .
-METHODS	PBW equations use height , age , and sex as input variables .
-METHODS	We compared National Institutes of Health ( NIH ) ARDS Network ( ARDSNet ) , actuarial table ( ACTUARIAL ) , and Stewart ( STEWART ) PBW equations used in clinical trials , across physiologic ranges for age and height .
-METHODS	We used three-dimensional and two-dimensional surface analysis to compare these PBW equations .
-METHODS	We then used age and height from actual clinical trial subjects to quantify PBW equation differences .
-RESULTS	Significant potential differences existed between these PBW predictions .
-RESULTS	The ACTUARIAL and ARDSNet surfaces for women were the only surfaces that intersected and produced both positive and negative differences .
-RESULTS	Mathematical differences between PBW equations at limits of height and age exceeded 30 % in women and 24 % in men for ACTUARIAL vs ARDSNet and about 25 % for women and 15 % for men for STEWART vs ARDSNet .
-RESULTS	The largest mathematical differences were present in older , shorter subjects , especially women .
-RESULTS	Actual differences for clinical trial subjects were as high as 15 % for men and 24 % for women .
-CONCLUSIONS	Significant differences between PBW equations for both men and women could be important sources of interstudy variation .
-CONCLUSIONS	Studies should adopt a standard PBW equation .
-CONCLUSIONS	We recommend using the NIH National Heart , Lung , and Blood Institute ARDS Network PBW equation because it is associated with the clinical trial that identified 6 mL/kg PBW as an appropriate target .
-
-###26035724
-OBJECTIVE	The authors examined the impacts of whole-body vibration ( WBV ) applications on balance control in postmenopausal women using clinical balance tests and computerized static posturography .
-METHODS	Patients were randomly divided into two groups and treated with WBV and/or home-based balance coordination exercises ( BCEs ) .
-METHODS	Patients in the WBV-BCE group were asked to stand on the platform in standing , squat , and deep squat positions .
-METHODS	During each position , 30-sec vibration ( 30-35 Hz ) and 60-sec rest periods were applied twice ( 20 sessions in total ) .
-METHODS	The BCE program was performed by subjects twice per day .
-METHODS	All subjects were evaluated before and after treatment using the Timed Up and Go test and the Berg Balance Scale ( BBS ) .
-METHODS	The fall index and the Fourier index were assessed via computerized static posturography .
-RESULTS	Sixty patients were recruited for the study , but only 42 patients ( 21 in each group ) completed it .
-RESULTS	Fall index and the total values of the Fourier index 2-4 and Fourier index 5-6 frequencies indicated a significant improvement in the WBV-BCE group ( P < 0.05 ) .
-RESULTS	Both groups showed significant improvements in the Berg Balance Scale and Timed Up and Go test ( P < 0.05 ) .
-CONCLUSIONS	The ease of applying WBV furthermore supports its inclusion in daily treatment protocols for age-related decline in balance performance in women and improved balance and mobility measures associated with increased fall risk .
-
-###25100891
-BACKGROUND	There is controversy in medical literature regarding the use of electromagnetic fields to promote bone healing .
-METHODS	After designing and building devices capable of generating an electromagnetic field for this study , their safety was confirmed and the electromagnetic therapy was randomly allocated and compared to placebo in patients with fracture of the femoral diaphysis .
-METHODS	Treatment began six weeks after the fracture and it was administered once a day , during 1 h , for eight consecutive weeks .
-METHODS	Twenty device were built , 10 of which were placebo-devices .
-METHODS	Between June 2008 and October 2009 , 64 patients were randomized in two different hospitals and were followed for 24 weeks .
-METHODS	The mean age was 30 years ( 18-59 ) and 81 % were males .
-RESULTS	Healing observed at week 12 was 75 % vs. 58 % ( p = 0.1 ) ; at week 18 it was 94 % vs. 80 % ( p = 0.15 ) ; and at week 24 it was 94 % vs. 87 % ( p = 0.43 ) for the device group and the placebo group , respectively .
-CONCLUSIONS	This study suggests that an electromagnetic field stimulus can promote earlier bone healing compared to placebo in femoral diaphyseal fractures .
-CONCLUSIONS	Faster bone healing translates into sooner weight bearing , which -- in turn -- permits quicker return to normal daily activities .
-
-###25046167
-OBJECTIVE	The aim of this study was to assess in healthy subjects the safety , tolerability , pharmacokinetics , and pharmacodynamics of ponesimod , an oral selective sphingosine-1-phosphate receptor 1 ( S1P1 ) modulator in development for multiple sclerosis , by using an uptitration scheme up to supratherapeutic doses .
-METHODS	This was a double-blind , placebo-controlled , randomised , parallel group , uptitration study .
-METHODS	Male and female subjects received ascending oral doses of ponesimod ( n = 12 ) or placebo ( n = 4 ) once daily for 3 days at each dose level ( 10-20-40-60-80-100mg ) .
-RESULTS	The most frequent adverse events were chest discomfort , headache , dizziness , dyspnoea , abdominal pain , and night sweats .
-RESULTS	Chest discomfort and dyspnoea were considered dose-limiting .
-RESULTS	A transient decrease in heart rate was observed following the first 10-mg ponesimod dose ( maximum mean decrease of 9 beats per minute ( bpm ) ( placebo : 2 bpm ) ) .
-RESULTS	After uptitration , effects on heart rate were indistinguishable from placebo .
-RESULTS	A dose-dependent effect on pulmonary function tests was observed and reached a plateau with 60-80 mg ponesimod ( maximum mean decrease from baseline of 1.24 l ( -30.5 % ) in forced expiratory volume in 1s ) .
-RESULTS	A plateau in mean lymphocyte count reduction of approximately 70 % from baseline was reached at the 40 mg dose level .
-RESULTS	Observed effects were fully reversible within 10days after treatment discontinuation .
-RESULTS	No relevant sex differences were observed .
-CONCLUSIONS	At supratherapeutic doses , symptoms of chest discomfort and dyspnoea were dose-limiting .
-CONCLUSIONS	An uptitration dosing scheme is to be preferred in clinical studies in patients in order to limit effects of ponesimod on heart rate and atrioventricular ( AV ) conduction .
-
-###24812022
-BACKGROUND	A recent meta-analysis of Internet interventions for smoking cessation found mixed evidence regarding effectiveness .
-BACKGROUND	One explanation may be differential use of non-assigned cessation treatments-including other Internet programs-that either amplify or mask study intervention effects .
-BACKGROUND	We examined the impact of non-assigned treatment use on cessation outcomes in The iQUITT Study , a randomized trial of Internet and telephone treatment for smoking cessation .
-METHODS	Participants were randomized to a basic Internet ( BI ) comparison condition ( N = 675 ) , enhanced Internet ( EI : N = 651 ) , or EI plus telephone counseling ( EI+P : N = 679 ) .
-METHODS	The primary outcome was 30-day point prevalence abstinence ( ppa ) at 3 and 6 months .
-METHODS	Assigned intervention use was assessed with automated tracking data .
-METHODS	Assessment of non-assigned treatments included pharmacotherapy , behavioral , alternative , and non-study Internet treatments .
-METHODS	Univariate and multivariate logistic regression models examined whether non-assigned treatment use was associated with 30-day ppa .
-RESULTS	About 70 % of participants used at least one non-assigned treatment .
-RESULTS	A higher rate of non-study Internet treatment among BI participants was the only treatment group difference at both 3 and 6 months .
-RESULTS	Multivariate models controlling for condition and baseline predictors of non-assigned treatment use showed that high-intensity non-study Internet treatment was positively associated with 30-day ppa at 3 and 6 months , and pharmacotherapy and behavioral treatment use was negatively associated with 30-day ppa at 6 months .
-CONCLUSIONS	Non-assigned treatment use is an important factor to consider when evaluating Internet cessation interventions .
-CONCLUSIONS	Results highlight methodological issues in selecting a comparison condition .
-CONCLUSIONS	Researchers should report non-assigned treatment use alongside main trial outcomes .
-
-###24423909
-OBJECTIVE	To explore the effects of nutritional liquid supplement designed for diabetes mellitus on postprandial glucose state and pregnancy outcomes in patients with gestational diabetes mellitus ( GDM ) .
-METHODS	A total of 69 cases of pregnant GDM women at Department of Obstetrics & Gynecology , First Affiliated Hospital , Chongqing Medical University from October 2011 to January 2012 were randomized into the intervention and control groups .
-METHODS	But only 31 cases in intervention group finished the study versus 29 cases in control group .
-METHODS	The inter-group differences were analyzed for general clinical profiles before intervention , 2-hour postprandial blood glucose levels and pregnancy outcomes , etc. .
-METHODS	The General Linear Model Repeated Measures process was used to analyze the variance of 2-hour postprandial blood glucose data .
-METHODS	And the Mauchy 's test of sphericity was employed to determine the correlation .
-RESULTS	( 1 ) No significant difference in general clinical profiles before intervention between intervention and control groups ( P > 0.05 ) .
-RESULTS	( 2 ) The mean values of 2-hour postprandial blood glucose were as follows : intervention group ( mmol/L ) : 6.2 0.7 ( 1w ) , 5.9 0.5 ( 2w ) , 5.7 0.5 ( 3w ) , 5.8 0.6 ( 4w ) , 5.7 0.5 ( 5w ) , 5.7 0.4 ( 6w ) , 5.9 0.3 ( 7w ) , 6.0 0.4 ( 8w ) , 6.0 0.5 ( 9w ) ; control group : 6.7 0.3 ( 1w ) , 6.2 0.4 ( 2w ) , 6.2 0.5 ( 3w ) , 6.2 0.4 ( 4w ) , 6.1 0.4 ( 5w ) , 6.0 0.3 ( 6w ) , 5.8 0.4 ( 7w ) , 6.1 0.4 ( 8w ) , 6.1 0.4 ( 9w ) .
-RESULTS	The results of Mauchy 's test of sphericity indicated that the blood glucose level of the intervention group was significantly lower than that of the control group ( P < 0.01 ) .
-RESULTS	( 3 ) The incidence of premature rupture of membranes and polyhydramnios , rate of neonatal pneumonia , weight of newborn and pregnancy women and level of glycosylated hemoglobin in intervention group were significantly lower than those in control group ( P < 0.05 ) .
-CONCLUSIONS	Compared with common diet , after using nutritional supplement , the postprandial blood glucose level is significantly reduced and the pregnancy outcomes also improved in GDM patients .
-
-###25753869
-OBJECTIVE	This prospective randomized study evaluated the efficacy of a 2.0 mm locking plate/screw system compared with a 2.0-mm nonlocking plate/screw system in fixation of 60 isolated non-comminuted mandibular angle fractures .
-METHODS	Sixty patients were randomly assigned to receive a 2.0 mm locking plate ( group A , n = 30 ) or 2.0 mm non-locking plate ( group B , n = 30 ) .
-METHODS	All patients were followed up to 6 months postoperatively and evaluated for complications , occlusal stability and overall results of fixation .
-RESULTS	Five complications occurred in the locking group and fourteen in the non-locking group with complication rates equalling 17 % and 47 % respectively .
-RESULTS	When comparing the overall results according to plates used , the test showed a statistically significant difference between the locking and non-locking plates ( p < 0.01 ) .
-RESULTS	Fewer patients required IMF in group A.
-CONCLUSIONS	Mandibular angle fractures treated with 2.0 mm locking plates show greater stability and were associated with fewer complications than with 2.0 mm non-locking plates .
-
-###25455875
-OBJECTIVE	To conduct a follow-up association mapping to independent genome-wide linkage and admixture mapping studies of uterine leiomyoma .
-METHODS	Case-control , cross-sectional study .
-METHODS	Not applicable .
-METHODS	A total of 1,045 premenopausal North American participants in the National Institute of Environmental Health Sciences Uterine Fibroid Study .
-METHODS	None .
-METHODS	We genotyped 2,772 single-nucleotide polymorphisms from candidate genes located in peaks of linkage ( 2q37 , 3p21 , 5p13 , 10p11 , 11p15 , 12q14 , and 17q25 ) or admixture linkage disequilibrium ( 2q37 , 4p16 .1 , and 10q26 ) mapping and reported to have regulated expression in uterine fibroids .
-RESULTS	We report significant associations of variant members of the collagen gene family with risk and tumor size , including missense variants in COL6A3 and COL13A , with replications in African American and European American study groups .
-RESULTS	Furthermore , the cell-matrix Rho GTPase-encoding ARHGAP26 gene , and MAN1C1 , a gene encoding a Golgi mannosidase involved in the maturation of procollagens , emerged as new candidate uterine leiomyoma genes affecting both risk and tumor size .
-CONCLUSIONS	Our data converge onto a possible model of uterine leiomyoma pathogenesis resulting from altered regulation , maintenance , and/or renewal of the extracellular matrix .
-
-###25616607
-OBJECTIVE	Ureaplasma urealyticum biovar 2 ( UU-2 ) , but not Ureaplasma parvum ( UP ) , has been associated with non-gonococcal urethritis ( NGU ) , but little is known about species-specific responses to standard therapies .
-OBJECTIVE	We examined species-specific treatment outcomes and followed men with treatment failure for 9weeks .
-METHODS	From May 2007 to July 2011 , men aged 16 attending a sexually transmitted disease ( STD ) clinic in Seattle , Washington , with NGU ( urethral discharge or urethral symptoms plus 5 polymorphonuclear leucocytes / high-powered field ) enrolled in a double-blind , randomised trial .
-METHODS	Participants received active azithromycin ( 1g ) + placebo doxycycline or active doxycycline ( 100mg twice a day 7days ) + placebo azithromycin .
-METHODS	Ureaplasma were detected in culture followed by species-specific PCR .
-METHODS	Outcomes were assessed at 3 , 6 and 9weeks .
-METHODS	At 3weeks , men with persistent Ureaplasma detection received ` reverse therapy ' ( e.g. , active doxycycline if they first received active azithromycin ) .
-METHODS	At 6weeks , persistently positive men received moxifloxacin ( 400mg7days ) .
-RESULTS	Of 490 men , 107 ( 22 % ) and 60 ( 12 % ) were infected with UU-2 and UP , respectively , and returned at 3weeks .
-RESULTS	Persistent detection was similar for UU-2-infected men initially treated with azithromycin or doxycycline ( 25 % vs. 31 % ; p = 0.53 ) , but differed somewhat for men with UP ( 45 % vs. 24 % ; p = 0.11 ) .
-RESULTS	At 6weeks , 57 % of UU-2-infected and 63 % of UP-infected men who received both drugs had persistent detection .
-RESULTS	Failure after moxifloxacin occurred in 30 % and 36 % , respectively .
-RESULTS	Persistent detection of UU-2 or UP was not associated with signs/symptoms of NGU .
-CONCLUSIONS	Persistent detection after treatment with doxycycline , azithromycin and moxifloxacin was common for UU and UP , but not associated with persistent urethritis .
-BACKGROUND	NCT00358462 .
-
-###24268433
-OBJECTIVE	To explore effects of whole-head/body tilt in the roll plane on ocular-vestibular evoked myogenic potentials ( oVEMP ) .
-METHODS	Twenty healthy subjects were randomly tilted in an Eply Omniax rotator across a series of eight angles from 0 to 360 ( at 45 separations ) in the roll plane .
-METHODS	At each position , oVEMPs to air-conducted ( AC ) and bone-conducted ( BC ) stimulation were recorded from unrectified infra-orbital surface electromyography during upward gaze .
-METHODS	oVEMP amplitudes , latencies and amplitude asymmetry were compared across each angle of orientation .
-RESULTS	Head orientation had a significant effect on oVEMP reflex amplitudes for both AC and BC stimulation ( p < 0.001 ) .
-RESULTS	For both stimuli there was a trend for lower amplitudes with increasing angular departure from the upright position .
-RESULTS	Mean amplitudes decreased by 42.6-56 .8 % ( AC ) and 23.2-25 .5 % ( BC ) when tilted 180 .
-RESULTS	Roll-plane tilt had a significant effect on amplitude asymmetry ratios recorded in response to AC stimuli ( p < 0.001 ) , indicating a trend for lower amplitudes from the dependent ( down ) ear .
-RESULTS	Amplitude asymmetry ratios for BC stimuli were unaffected by head and body orientation .
-CONCLUSIONS	The results confirm an effect of head and body orientation on oVEMP reflexes recorded in response to air - and bone-conducted stimuli .
-CONCLUSIONS	The upright position yields an optimal oVEMP response .
-
-###25748566
-OBJECTIVE	To evaluate the efficacy and safety of nebulized pentoxifylline for reducing the duration of oxygen supplementation in extremely preterm neonates at high risk of bronchopulmonary dysplasia ( BPD ) .
-METHODS	Single-center , randomized , double-blind , placebo-controlled trial was conducted .
-METHODS	Infants of 23 ( 0 ) to 27 ( 6 ) weeks ' gestational age requiring mechanical ventilation or 30 % supplemental oxygen on continuous positive airway pressure at 72-168 hours were randomized to receive 20 mg/kg ( 1 mL/kg ) nebulized pentoxifylline or an equal volume of normal saline placebo every 6 hours for 10 consecutive days via a vibrating mesh nebulizer .
-METHODS	The primary outcome was the duration of oxygen supplementation at 40 weeks ' postmenstrual age .
-METHODS	We used Cox proportional hazards regression modeling to analyze outcomes .
-RESULTS	All infants had adequate data for analysis of the primary outcome .
-RESULTS	Intention-to-treat analysis revealed no differences in duration of oxygen supplementation at 40 weeks ' postmenstrual age between pentoxifylline ( n = 41 ) and placebo ( n = 40 ) groups ( median 2262 vs 2160 hours , adjusted hazard ratio : 1.14 , 95 % CI 0.72-1 .80 , P = .63 ) .
-RESULTS	There was no difference in mortality and further secondary outcomes .
-RESULTS	No adverse effects were noted .
-CONCLUSIONS	Nebulized pentoxifylline is safe but did not reduce the duration of oxygen supplementation in extremely preterm infants at high risk of BPD .
-CONCLUSIONS	Dose-ranging studies and large , well-designed clinical trials are required to determine whether the use of nebulized or systemic pentoxifylline as a prophylactic therapy offers small but relevant benefits for prevention of BPD .
-BACKGROUND	Australian New Zealand Clinical Trials Registry : ACTRN12611000145909 .
-
-###24821270
-BACKGROUND	Secondhand smoke exposure ( SHSe ) is a significant modifiable risk for respiratory health in children .
-BACKGROUND	Although SHSe is declining overall , it has increased for low-income and minority populations .
-BACKGROUND	Implementation of effective SHSe interventions within community organizations has the potential for significant public health impact .
-OBJECTIVE	To evaluate the effectiveness of motivational interviewing ( MI ) delivered in the context of a SHS education reduction initiative within Head Start to reduce preschool children 's SHSe .
-METHODS	A total of 350 children enrolled in Baltimore City Head Start whose caregivers reported a smoker living in the home were recruited .
-METHODS	Caregivers were randomized to MI + education or education alone .
-METHODS	Assessments were conducted at baseline , 3 , 6 , and 12 months .
-RESULTS	The primary outcome measure was household air nicotine levels measured by passive dosimeters .
-RESULTS	Secondary outcomes included child salivary cotinine , self-report of home smoking ban ( HSB ) , and smoking status .
-RESULTS	Participants in the MI + education group had significantly lower air nicotine levels ( 0.29 vs. 0.40 mg ) , 17 % increase in prevalence of caregiver-reported HSBs , and a 13 % decrease in caregiver smokers compared with education-alone group ( all P values < 0.05 ) .
-RESULTS	Although group differences in salivary cotinine were not significant , among all families who reported having an HSB , salivary cotinine and air nicotine levels declined in both groups ( P < 0.05 ) .
-CONCLUSIONS	MI may be effective in community settings to reduce child SHSe .
-CONCLUSIONS	More research is needed to identify ways to tailor interventions to directly impact child SHSe and to engage more families to make behavioral change .
-CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 00927264 ) .
-
-###24460292
-BACKGROUND	Conspicuous differences in participation rates for breast self-examination ( BSE ) , clinical breast examination ( CBE ) , and referral for further investigations have been observed indicating involvement of a number of different factors .
-BACKGROUND	This study analysed determinants for participation in different levels of the breast cancer screening process in Indian females .
-METHODS	An intervention group of 52,011 women was interviewed in a breast cancer screening trial in Trivandrum district , India .
-METHODS	In order to assess demographic , socio-economic , reproductive , and cancer-related determinants of participation in BSE , CBE , and referral , uni - and multi-variate logistic regression was employed .
-RESULTS	Of the interviewed women , 23.2 % reported practicing BSE , 96.8 % had attended CBE , and 49.1 % of 2,880 screen-positives attended referral .
-RESULTS	Results showed an influence of various determinants on participation ; women who were currently not married or who had no family history of cancer were significantly less likely to attend the screening process at any level .
-CONCLUSIONS	Increasing awareness about breast cancer , early detection methods , and the advantages of early diagnoses among women , and their families , as well as health care workers offering social support , could help to increase participation over the entire screening process in India .
-
-###25963602
-BACKGROUND	Reducing consumption of food away from home is often targeted during pediatric obesity treatment , given the associations with weight status and gain .
-BACKGROUND	However , the effects of this dietary change on weight loss are unknown .
-OBJECTIVE	Our aim was to evaluate associations between changes in dietary factors and child anthropometric outcomes after treatment .
-OBJECTIVE	It is hypothesized that reduced consumption of food away from home will be associated with improved dietary intake and greater reductions in anthropometric outcomes ( standardized body mass index [ BMI ] and percent body fat ) , and the relationship between food away from home and anthropometric outcomes will be mediated by improved child dietary intake .
-METHODS	We conducted a longitudinal evaluation of associations between dietary changes and child anthropometric outcomes .
-METHODS	Child diet ( three 24-hour recalls ) and anthropometric data were collected at baseline and 16 weeks .
-METHODS	Participants were 170 overweight and obese children ages 7 to 11 years who completed a 16-week family-based behavioral weight-loss treatment as part of a larger multi-site randomized controlled trial conducted in two cohorts between 2010 and 2011 ( clinical research trial ) .
-METHODS	Dietary treatment targets during family-based behavioral weight-loss treatment included improving diet quality and reducing food away from home .
-METHODS	The main outcome measures in this study were child relative weight ( standardized BMI ) and body composition ( percent body fat ) .
-METHODS	We performed t tests and bootstrapped single-mediation analyses adjusting for relevant covariates .
-RESULTS	As hypothesized , decreased food away from home was associated with improved diet quality and greater reductions in standardized BMI ( P < 0.05 ) and percent body fat ( P < 0.01 ) .
-RESULTS	Associations between food away from home and anthropometric outcomes were mediated by changes in diet quality .
-RESULTS	Specifically , change in total energy intake and added sugars mediated the association between change in food away from home and standardized BMI , and change in overall diet quality , fiber , added sugars , and added fats mediated the association between change in food away from home and percent body fat .
-RESULTS	Including physical activity as a covariate did not significantly impact these findings .
-CONCLUSIONS	These results suggest that reducing food away from home can be an important behavioral target for affecting positive changes in both diet quality and anthropometric outcomes during treatment .
-
-###24767956
-BACKGROUND	Music has been employed in various clinical settings to reduce anxiety .
-BACKGROUND	However , meta-analysis has shown music to have little influence on haemodynamic parameters .
-BACKGROUND	This study aimed at investigating the effect of relaxing music on heart rate recovery after exercise .
-METHODS	Twenty-three student volunteers underwent treadmill exercise and were assessed for heart rate recovery and saliva analysis ; comparing exposure to sedative music with exposure to silence during the recovery period immediately following exercise .
-RESULTS	No differences were found between music and non-music exposure regarding : heart rate recovery , resting pulse rate , and salivary cortisol .
-RESULTS	Music was no different to silence in affecting these physiological measures , which are all associated with anxiety .
-CONCLUSIONS	Relaxing music unaccompanied by meditation techniques or other such interventions may not have a major role in reducing anxiety in certain experimental settings .
-
-###24254035
-BACKGROUND	Fatigue is one problem that is seen in high numbers in hemodialysis patients .
-BACKGROUND	Fatigue decreases quality of life by negatively affecting an individual 's daily performance , activities , professional life , relations with family and friends , and treatment process .
-OBJECTIVE	This study was carried out to determine the effect of acupressure on the level of fatigue in hemodialysis patients .
-METHODS	The study was conducted as experimental research with an acupressure ( intervention ) group and a control group .
-METHODS	The research , for which an ethics committee 's approval and institutional permission was obtained , was conducted in two central provinces of Turkey , Nevehir and Aksaray , at two hemodialysis centers with similar characteristics .
-METHODS	The research was completed with a total of 118 participants ( 52 in the intervention group and 66 in the control group ) who met the inclusion criteria .
-METHODS	A total of 12 acupressure sessions , 3 / wk for 1 mo , were performed for all participants in the intervention group , as required by the acupressure application protocol , applying acupressure at the Stomach 36 ( ST-36 ) , Gallbladder 34 ( GB-34 ) , Spleen 6 ( SP-6 ) , and Kidney 1 ( K-1 ) acupuncture points with a transcutaneous electrical nerve stimulation ( TENS ) acupuncture pen ( XFT-320 acupuncture pen , Shenzhen Xunfegtong Electronics Co , Ltd , Shenzhen , China ) .
-METHODS	A visual analog scale ( VAS ) for fatigue and the Piper Fatigue Scale ( PFS ) were used to evaluate the fatigue level of the participants before and after the acupressure application .
-RESULTS	After the acupressure applications for 1 mo , the subscale and total fatigue scores for the VAS ( P < .001 ) and PFS were lower ( P < .05 ) for participants in the intervention group compared to the controls , except for the cognitive subscale on the PFS ( P < .05 ) .
-CONCLUSIONS	The study found that acupressure , applied using an acupuncture pen , was effective in decreasing fatigue in hemodialysis patients .
-CONCLUSIONS	Based on this result , the current research team suggests that hemodialysis patients and nurses should be informed about acupressure application so as to extend the use of acupressure in reducing fatigue symptoms .
-
-###25944606
-OBJECTIVE	The aim of our study was to measure the volume of gestational sac and amniotic sac in physiological pregnancies and missed abortion .
-OBJECTIVE	We wanted to create nomograms for individual weeks of gestation .
-METHODS	Retrospective cohort study .
-METHODS	Institute for the Care of Mother and Child , Prague .
-METHODS	The study randomized 413 women after spontaneous conception .
-METHODS	The patients were divided into two groups : women with physiological pregnancy and childbirth in the period ( 374 ) , and women with pregnancy terminated by missed abortion .
-METHODS	Both groups were performed measurement volume of gestational and amniotic sac in the first trimester of pregnancy .
-METHODS	Analysis was performed using 4D View software applications , and volume calculations were performed using VOCAL ( Virtual Organ Computer Aided anaLysis ) .
-RESULTS	We have created the first in the Czech Republic nomograms volumes of gestational and amniotic sac in physiological pregnancies and missed abortion .
-RESULTS	We performed a correlation between the size of gestational sac and prosperity pregnancy .
-CONCLUSIONS	In our study we found no correlation between the volume of gestational sac and the development of the pregnancy .
-
-###26115386
-OBJECTIVE	To evaluate the effect of structured physical activity on sleep-wake behaviors in sedentary community-dwelling elderly adults with mobility limitations .
-METHODS	Multicenter , randomized trial of moderate-intensity physical activity versus health education , with sleep-wake behaviors prespecified as a tertiary outcome over a planned intervention period ranging from 24 to 30 months .
-METHODS	Lifestyle Interventions and Independence for Elders Study .
-METHODS	Community-dwelling persons aged 70 to 89 who were initially sedentary and had a Short Physical Performance Battery score less than 10 ( N = 1,635 ) .
-METHODS	Sleep-wake behaviors were evaluated using the Insomnia Severity Index ( ISI ) ( 8 defined insomnia ) , Epworth Sleepiness Scale ( ESS ) ( 10 defined daytime drowsiness ) , and Pittsburgh Sleep Quality Index ( PSQI ) ( > 5 defined poor sleep quality ) administered at baseline and 6 , 18 , and 30 months .
-RESULTS	The randomized groups were similar in terms of baseline demographic variables , including mean age ( 79 ) and sex ( 67 % female ) .
-RESULTS	Structured physical activity resulted in a significantly lower likelihood of having poor sleep quality ( adjusted odds ratios ( aOR ) for PSQI > 5 = 0.80 , 95 % confidence interval ( CI ) = 0.68-0 .94 ) , including fewer new cases ( aOR for PSQI > 5 = 0.70 , 95 % CI = 0.54-0 .89 ) , than health education but not in resolution of prevalent cases ( aOR for PSQI 5 = 1.13 , 95 % CI = 0.90-1 .43 ) .
-RESULTS	No significant intervention effects were observed for the ISI or ESS .
-CONCLUSIONS	Structured physical activity resulted in a lower likelihood of developing poor sleep quality ( PSQI > 5 ) over the intervention period than health education but had no effect on prevalent cases of poor sleep quality or on sleep-wake behaviors evaluated using the ISI or ESS .
-CONCLUSIONS	These results suggest that the benefit of physical activity in this sample was preventive and limited to sleep-wake behaviors evaluated using the PSQI .
-
-###25052238
-BACKGROUND	The results of preclinical studies suggest that baclofen may be useful in the treatment of stroke patients with persistent hiccups .
-BACKGROUND	This study was aimed to assess the possible efficacy of baclofen for the treatment of persistent hiccups after stroke .
-METHODS	In total , 30 stroke patients with persistent hiccups were randomly assigned to receive baclofen ( n = 15 ) or a placebo ( n = 15 ) in a double-blind , parallel-group trial .
-METHODS	Participants in the baclofen group received 10mg baclofen 3 times daily for 5days .
-METHODS	Participants assigned to the placebo group received 10mg placebo 3 times daily for 5days .
-METHODS	The primary outcome measure was cessation of hiccups .
-METHODS	Secondary outcome measures included efficacy in the two groups and adverse events .
-RESULTS	All 30 patients completed the study .
-RESULTS	The number of patients in whom the hiccups completely stopped was higher in the baclofen group than in the placebo group ( relative risk , 7.00 ; 95 % confidence interval , 1.91-25 .62 ; P = 0.003 ) .
-RESULTS	Furthermore , efficacy was higher in the baclofen group than in the placebo group ( P < 0.01 ) .
-RESULTS	No serious adverse events were documented in either group .
-RESULTS	One case each of mild transient drowsiness and dizziness was present in the baclofen group .
-CONCLUSIONS	Baclofen was more effective than a placebo for the treatment of persistent hiccups in stroke patients .
-BACKGROUND	Chinese Clinical Trials Register : ChiCTR-TRC-13004554 .
-
-###24456999
-BACKGROUND	A cardiac arrest can lead to hypoxic-ischaemic brain injury which can result in cognitive and emotional impairments and may negatively affect daily functioning , participation in society and quality of life .
-BACKGROUND	Furthermore , the impact on the family of the patient can be high .
-BACKGROUND	We designed an intervention called ` Stand still , and move on ' , which is a concise , individualised , semi-structured intervention for survivors of cardiac arrest and their caregivers , consisting of between one and six face-to-face consultations provided by a trained nurse .
-BACKGROUND	The intervention is directed at early detection of cognitive and emotional problems , provision of information , promotion of self-management and referral to specialised care if necessary .
-BACKGROUND	The effectiveness of the intervention is being examined in a randomised controlled trial [ ISRCTN74835019 ] .
-BACKGROUND	Alongside this trial we performed a process evaluation which aims to investigate the feasibility of the intervention by assessing : 1 ) the attendance and dose delivered ; 2 ) performance according to protocol ; and 3 ) the opinion of patients , caregivers and nurses on the intervention .
-METHODS	Participants of this process evaluation were 97 patients allocated to the intervention group of the RCT , their 91 caregivers , and six nurses who conducted the intervention .
-METHODS	Measurement instruments used were evaluation forms for patients and caregivers , registration and evaluation forms for nurses , and semi-structured interviews with nurses .
-RESULTS	Seventy-nine of the patients ( 81 % ) allocated to the intervention group and 65 caregivers ( 71 % ) participated in the intervention .
-RESULTS	The mean ( SD ) number of consultations per patient was 1.8 ( 1.0 ) , and most consultations were conducted at the patients ' home .
-RESULTS	The intervention was performed largely according to protocol , except that the intervention usually started later than intended , consultations were longer than expected , and the topic of self-management was not regularly addressed .
-RESULTS	Patients marked the quality of the intervention with a mean score of 7.5 and the performance of the nurse with an 8.0 out of ten .
-RESULTS	Overall , the intervention was positively evaluated by patients , caregivers and nurses .
-CONCLUSIONS	The intervention ` Stand still , and move on ' is a promising intervention which was performed largely according to protocol and seems feasible for implementation after some adaptations , if it is found to be effective .
-
-###24639290
-OBJECTIVE	To investigate the efficacy of bupivacaine-soaked spongostan in cesarean section wound for postoperative anxiety level , satisfaction and early postpartum depression rate .
-METHODS	A total of 121 women , American Society of Anesthesiologists physical status I-II , scheduled to undergo general anesthesia and elective cesarean section were recruited and randomized into a study group ( n = 61 ) or a control group ( n = 60 ) .
-METHODS	In the spongostan group , bupivacaine-soaked spongostan was placed in the cesarean section wound .
-METHODS	The control group did not receive spongostan , but only general postoperative care .
-METHODS	Maternal health was assessed using a visual analog scale for satisfaction , a visual analog scale for anxiety and the Edinburgh Postpartum Depression Scale for postpartum depression .
-METHODS	Also , first breast-feeding time , first mobilization time and opioid consumption were recorded and compared .
-RESULTS	The anxiety level of the spongostan group was lower than that of the control group and the difference was statistically significant at all time intervals ( 1 , 6 , 12 , 18 , 24 , 30 , 36 and 48 h , p < 0.001 , respectively ) .
-RESULTS	Postpartum depression rate again was significantly lower in the spongostan group both on postoperative day 2 and day 9 ( p 0.01 ) .
-RESULTS	All satisfaction scores were significantly higher in the spongostan group than in the control group ( p < 0.001 ) .
-RESULTS	Additionally , first breast-feeding and first mobilization times were significantly shorter and opioid consumption was lower in the spongostan group ( p < 0.001 ) .
-CONCLUSIONS	Placement of bupivacaine-soaked spongostan into the cesarean section wound resulted in decreased postoperative anxiety level and postpartum depression rate and increased satisfaction .
-
-###25239078
-OBJECTIVE	Chronic hepatitis C treatment for prior non-responders to peginterferon ( PegIFN ) / ribavirin remains suboptimal .
-OBJECTIVE	The MATTERHORN study evaluated regimens containing ritonavir-boosted danoprevir ( danoprevir/r ) in prior PegIFN alfa/ribavirin non-responders .
-METHODS	Prior partial responders ( N = 152 ) were randomized to 24 weeks of twice-daily danoprevir/r 100/100mg , mericitabine 1000 mg and ribavirin 1000/1200 mg ( IFN-free ) ; danoprevir/r plus PegIFN alfa-2a / ribavirin ( triple ) ; or danoprevir/r , mericitabine and PegIFN alfa-2a / ribavirin ( Quad ) .
-METHODS	Prior null responders ( N = 229 ) were randomized to 24 weeks of IFN-free therapy , or quad alone ( Quad 24 ) or quad plus 24-weeks of PegIFN alfa-2a / ribavirin ( Quad 48 ) .
-METHODS	The primary endpoint was sustained virological response ( HCV RNA < 25 IU/ml ) 24 weeks after end-of-treatment ( SVR24 ) .
-METHODS	Due to high relapse rates , genotype ( G ) 1a patients in IFN-free arms were offered additional PegIFN alfa-2a / ribavirin .
-RESULTS	Among prior partial responders , SVR24 rates were 46.2 % , 51.0 % , and 86.0 % , in the IFN-free , Triple and Quad arms , respectively ; among prior null responders , SVR24 rates were 45.5 % , 80.5 % , and 83.8 % respectively .
-RESULTS	Relapse rates were lower and SVR24 rates higher in G1b-infected than G1a-infected patients .
-RESULTS	SVR24 rates in G1a and G1b patients randomized to Quad were 75.0 % and 96.2 % , respectively , in the partial Quad arm , and 68.1 % and 100 % , respectively , in the null Quad 24 arm .
-RESULTS	Treatment failure was associated with resistance to danoprevir , but not to mericitabine , and was more common in G1a infected patients .
-RESULTS	Treatment was well-tolerated .
-CONCLUSIONS	Danoprevir/r , mericitabine plus PegIFN alfa-2a / ribavirin was well-tolerated and produced high overall SVR24 rates in prior partial and null responders to PegIFN alfa/ribavirin .
-CONCLUSIONS	In contrast , IFN-free regimens were associated with unacceptably high relapse rates .
-
-###24411718
-BACKGROUND	Long chain omega-3 polyunsaturated fatty acids ( LC n-3 PUFA ) such as EPA and DHA have been shown to possess beneficial health effects , and it is believed that many of their effects are mediated by their oxygenated products ( oxylipins ) .
-BACKGROUND	Recently , we have shown that serum levels of several hydroxy , epoxy , and dihydroxy FAs are dependent on the individual status of the parent FAs in a cohort of normo - and hyperlipidemic subjects .
-BACKGROUND	So far , the effect of an increased dietary LC n-3 PUFA intake on hydroxy , epoxy , and dihydroxy FA levels has not been investigated in subjects with mild combined hyperlipidemia .
-METHODS	In the present study , we compared oxylipin patterns of 10 hyperlipidemic ( cholesterol > 200mg/dl ; triglyceride > 150mg/ml ) and 10 normolipidemic men in response to twelve weeks of LC n-3 PUFA intake ( 1.14 g DHA and 1.56 g EPA ) .
-METHODS	Levels of 44 free hydroxy , epoxy and dihydroxy FAs were analyzed in serum by LC-MS .
-METHODS	Additionally , oxylipin levels were compared with their parent PUFA levels in erythrocyte membranes ; a biomarker for the individual PUFA status .
-RESULTS	Differences in the oxylipin pattern between normo - and hyperlipidemic subjects were minor before and after treatment .
-RESULTS	In all subjects , levels of EPA-derived oxylipins ( 170-4800pM ) were considerably elevated after LC n-3 PUFA intake ( 150-1400 % ) , the increase of DHA-derived oxylipins ( 360-3900pM ) was less pronounced ( 30-130 % ) .
-RESULTS	The relative change of EPA in erythrocyte membranes is strongly correlated ( r0 .5 ; p < 0.05 ) with the relative change of corresponding epoxy and dihydroxy FA serum levels .
-RESULTS	The effect on arachidonic acid ( AA ) - derived oxylipin levels ( 140-27 ,100 pM ) was inconsistent .
-CONCLUSIONS	The dietary LC PUFA composition has a direct influence on the endogenous oxylipin profile , including several highly biological active EPA - and DHA-derived lipid mediators .
-CONCLUSIONS	The shift in oxylipin pattern appears to be dependent on the initial LC PUFA status particularly for EPA .
-CONCLUSIONS	The finding that also levels of other oxylipins derived from ALA , LA or AA are modified by LC n-3 PUFA intake might suggest that at least some of the effects of EPA and DHA could be mediated by a shift in the entire oxylipin profile .
-
-###25711322
-OBJECTIVE	A small subset of HIV-positive adults have low HIV RNA in the absence of therapy , sometimes for years .
-OBJECTIVE	Clinical factors associated with low HIV RNA in early infection have not been well defined .
-METHODS	We assessed factors associated with low plasma HIV RNA level at study entry in the Strategic Timing of AntiRetroviral Treatment ( START ) trial .
-METHODS	All START participants had a baseline HIV RNA assessment within 60 days prior to randomization .
-METHODS	The key covariables considered for this analysis were race , and hepatitis B virus ( HBV ) and hepatitis C virus ( HCV ) status .
-METHODS	We assessed factors associated with HIV RNA 50 and 400 HIV-1 RNA copies/mL using logistic regression .
-METHODS	Because of the strong association between region of randomization and baseline low HIV RNA , analyses were stratified by region .
-RESULTS	We found that , of 4676 eligible participants randomized in START with a baseline HIV RNA assessment , 113 ( 2.4 % ) had HIV RNA 50copies/mL at baseline , and a further 257 ( 5.5 % ) between 51 and 400copies/mL .
-RESULTS	We found that HIV exposure routes other than male homosexual contact , higher high-density lipoprotein ( HDL ) cholesterol levels , higher CD4 cell counts , and higher CD4 : CD8 ratio were associated with increased odds of low HIV RNA .
-RESULTS	HCV antibody positivity was borderline statistically significantly associated with low HIV RNA .
-RESULTS	Race and HBV surface antigen positivity were not significantly associated with low HIV RNA .
-CONCLUSIONS	In a modern cohort of individuals with early untreated HIV infection , we found that HIV exposure routes other than male homosexual contact and higher HDL cholesterol were associated with increased odds of low HIV RNA .
-
-###24423823
-OBJECTIVE	To compare the efficacy and toxicity of chemotherapy under the guidance of molecular markers and with vinorelbine in elderly patients with epidermal growth factor receptor ( EGFR ) wild-type advanced non-small cell lung cancer ( NSCLC ) .
-METHODS	A total of 86 elderly patients with pathologically-confirmed advanced NSCLC with EGFR wild-type were recruited between June 2010 to October 2012 .
-METHODS	There were 69 males and 17 females , aging from 70 to 83 years .
-METHODS	They were divided randomly into 2 groups according to the proportion of 1 : 1 by SPSS 16.0 software .
-METHODS	The study group received chemotherapy ( cisplatin , gemcitabine , paclitaxel , and pemetrexed ) under the guidance of molecular markers ( excision repair cross-complementing 1 ERCC1 , ribonucleotide reductase M1 RRM1 , Class III beta-tubulin , thymidylate synthetase TS ) .
-METHODS	The control group received vinorelbine 25 mg/m ( 2 ) days 1 and 8 with 21 days as a cycle .
-RESULTS	The progression-free survival ( PFS ) of the study group and the control group was 4.0 months ( 95 % CI : 3.1-4 .9 ) and 3.0 months ( 95 % CI : 2.4-3 .6 ) respectively , the difference being statistically significant ( ( 2 ) = 4.750 , P = 0.029 ) .
-RESULTS	The objective response rate ( ORR ) was 23 % ( 10/43 ) and 19 % ( 8/43 ) ( ( 2 ) = 0.281 , P = 0.596 ) , the disease control rate ( DCR ) was 79 % ( 34/43 ) and 77 % ( 33/43 ) ( ( 2 ) = 0.068 , P = 0.795 ) , and the median overall survival ( OS ) was 8.3 months and 7.5 months ( ( 2 ) = 0.756 , P = 0.385 ) , respectively ; the differences being not significant .
-RESULTS	Adverse effects were similar between the study group and the control group .
-RESULTS	The most commonly seen adverse events were hematological toxicity , nausea , vomiting , fatigue , alopecia , joint and muscle pain .
-RESULTS	Most of the toxicity was of grade I and grade II .
-RESULTS	There was no treatment-related death .
-CONCLUSIONS	The PFS was prolonged in elderly patients with EGFR wild-type advanced NSCLC under the guidance of molecular markers , but there was no improvement in ORR , DCR and OS .
-CONCLUSIONS	Further studies are needed to evaluate the clinical significance of this treatment modality .
-
-###24831394
-OBJECTIVE	To investigate the modulatory effects that dynamic hyperinflation ( DH ) , defined as a reduction in inspiratory capacity ( IC ) , has on exercise tolerance after bronchodilator in patients with COPD .
-METHODS	An experimental , randomized study involving 30 COPD patients without severe hypoxemia .
-METHODS	At baseline , the patients underwent clinical assessment , spirometry , and incremental cardiopulmonary exercise testing ( CPET ) .
-METHODS	On two subsequent visits , the patients were randomized to receive a combination of inhaled fenoterol/ipratropium or placebo .
-METHODS	All patients then underwent spirometry and submaximal CPET at constant speed up to the limit of tolerance ( Tlim ) .
-METHODS	The patients who showed IC ( peak-rest ) < 0 were considered to present with DH ( DH + ) .
-RESULTS	In this sample , 21 patients ( 70 % ) had DH .
-RESULTS	The DH + patients had higher airflow obstruction and lower Tlim than did the patients without DH ( DH - ) .
-RESULTS	Despite equivalent improvement in FEV1 after bronchodilator , the DH - group showed higher IC ( bronchodilator-placebo ) at rest in relation to the DH + group ( p < 0.05 ) .
-RESULTS	However , this was not found in relation to IC at peak exercise between DH + and DH - groups ( 0.19 0.17 L vs. 0.17 0.15 L , p > 0.05 ) .
-RESULTS	In addition , both groups showed similar improvements in Tlim after bronchodilator ( median [ interquartile range ] : 22 % [ 3-60 % ] vs. 10 % [ 3-53 % ] ; p > 0.05 ) .
-CONCLUSIONS	Improvement in TLim was associated with an increase in IC at rest after bronchodilator in HD - patients with COPD .
-CONCLUSIONS	However , even without that improvement , COPD patients can present with greater exercise tolerance after bronchodilator provided that they develop DH during exercise .
-
-###24394686
-BACKGROUND	Acute otitis media ( AOM ) is a common childhood illness and the leading indication for antibiotic prescriptions for US children .
-BACKGROUND	Xylitol , a naturally occurring sugar alcohol , can reduce AOM when given 5 times per day as a gum or syrup , but a more convenient dosing regimen is needed for widespread adoption .
-METHODS	We designed a pragmatic practice-based randomized controlled trial to determine if viscous xylitol solution at a dose of 5 g 3 times per day could reduce the occurrence of clinically diagnosed AOM among otitis-prone children 6 months through 5 years of age .
-RESULTS	A total of 326 subjects were enrolled , with 160 allocated to xylitol and 166 to placebo .
-RESULTS	In the primary analysis of time to first clinically diagnosed AOM episode , the hazard ratio for xylitol versus placebo recipients was 0.88 ( 95 % confidence interval [ CI ] 0.61 to 1.3 ) .
-RESULTS	In secondary analyses , the incidence of AOM was 0.53 episodes per 90 days in the xylitol group versus 0.59 in the placebo group ( difference 0.06 ; 95 % CI -0.25 to 0.13 ) ; total antibiotic use was 6.8 days per 90 days in the xylitol group versus 6.4 in the placebo group ( difference 0.4 ; 95 % CI -1.8 to 2.7 ) .
-RESULTS	The lack of effectiveness was not explained by nonadherence to treatment , as the hazard ratio for those taking nearly all assigned xylitol compared with those taking none was 0.93 ( 95 % CI 0.56 to 1.57 ) .
-CONCLUSIONS	Viscous xylitol solution in a dose of 5 g 3 times per day was ineffective in reducing clinically diagnosed AOM among otitis-prone children .
-
-###24374549
-OBJECTIVE	To compare efficacy and safety of thromboprophylaxis with semuloparin started postoperatively versus enoxaparin started preoperatively in major abdominal surgery .
-BACKGROUND	Venous thromboembolism is an important complication following major abdominal surgery .
-BACKGROUND	Semuloparin is a novel ultra-low-molecular-weight heparin with high antifactor Xa and minimal antifactor IIa activity .
-METHODS	In this double-blind noninferiority trial , adult patients undergoing major abdominal or pelvic operation under general anesthesia lasting more than 45 minutes were assigned to either daily enoxaparin 40 mg commenced preoperatively or daily semuloparin 20 mg commenced postoperatively , for 7 to 10 days .
-METHODS	Patients underwent bilateral leg venography between 7 and 11 days postsurgery .
-METHODS	The primary efficacy end point was the composite of any deep vein thrombosis , nonfatal pulmonary embolism , or all-cause death .
-METHODS	The primary safety outcome was bleeding .
-METHODS	Both were independently adjudicated .
-RESULTS	In total , 4413 patients were randomized ; 3030 ( 1499 in the enoxaparin and 1531 in the semuloparin groups ) were evaluable for the primary efficacy end point , which occurred in 97 patients ( 6.3 % ) in the semuloparin group and 82 patients ( 5.5 % ) in the enoxaparin group [ odds ratio ( OR ) = 1.16 , 95 % confidence interval ( CI ) : 0.84-1 .59 ] .
-RESULTS	On the basis of a noninferiority margin of 1.25 , postoperative semuloparin did not demonstrate noninferiority to preoperative enoxaparin .
-RESULTS	Major bleeding occurred in 63 of 2175 patients ( 2.9 % ) in the semuloparin group and 98 of 2177 patients ( 4.5 % ) in the enoxaparin group ( OR = 0.63 , 95 % CI : 0.46-0 .87 ) .
-CONCLUSIONS	Semuloparin commenced postoperatively did not demonstrate noninferiority to enoxaparin initiated preoperatively for thromboprophylaxis after major abdominal surgery .
-CONCLUSIONS	Study registered with clinicaltrials.gov : NCT00679588 .
-
-###25375851
-OBJECTIVE	To compare visual outcome , higher-order aberrations , and corneal asphericity ( Q value ) between wavefront-guided and aspheric LASIK for myopia and myopic astigmatism .
-METHODS	Forty patients were randomly selected to receive wavefront-guided LASIK ( wavefront-guided group ) or aspheric LASIK ( aspheric group ) ( 40 eyes of 20 patients in each group ) using the Technolas 217z excimer laser platform ( Bausch & Lomb , Rochester , NY ) .
-METHODS	Flaps were created using the Zyoptix XP microkeratome ( Bausch & Lomb ) .
-METHODS	Preoperative and postoperative evaluation included uncorrected distance visual acuity ( UDVA ) , corneal topography , wavefront aberrometry , and contrast sensitivity .
-METHODS	Minimum follow-up period was 6 months .
-RESULTS	At 6 months postoperatively , the aspheric group had significantly better UDVA ( logMAR 0.04 0.04 [ Snellen 20/16 ] [ range : -0.079 to 0.000 ] ) and lower mean residual spherical error ( +0.10 0.52 diopters [ D ] [ range : -1.12 to 1.25 D ] ) than the wavefront-guided group ( logMAR UDVA 0.00 0.07 [ range : -0.079 to 0.176 ] ; MRSE -0.35 0.47 D [ range : -1.5 to 0.62 D ] ) ( P = .003 and < .001 , respectively ) .
-RESULTS	Mean change in higher-order aberration root mean square at 6 months postoperatively ( 6-mm pupil ) was 0.16 0.17 m after aspheric LASIK and 0.27 0.28 m after wavefront-guided LASIK ( P = .02 ) .
-RESULTS	Aspheric LASIK induced minimal change in spherical aberrations postoperatively ( 0.03 0.12 m , P = .09 ) , unlike wavefront-guided LASIK ( 0.23 0.17 m , P < .01 ) .
-RESULTS	Change in Q value was significantly less in the aspheric group ( 0.53 0.31 ) than the wavefront-guided group ( 0.91 0.30 ) ( P < .01 ) .
-RESULTS	The aspheric group had significant improvement in contrast sensitivity at all spatial frequencies ( P < .01 ) , whereas the wavefront-guided group showed a slight decrease at higher spatial frequency ( 18 cycles per degree ) .
-CONCLUSIONS	Aspheric LASIK induced significantly less change in higher-order aberrations and maintained corneal asphericity better than wavefront-guided LASIK .
-CONCLUSIONS	The visual outcome and contrast sensitivity was better in the aspheric group at 6 months postoperatively .
-
-###25029424
-BACKGROUND	Hyperparathyroidism occurs frequently in X-linked hypophosphatemia ( XLH ) and may exacerbate phosphaturia , potentially affecting skeletal abnormalities .
-OBJECTIVE	The objective of the study was to suppress elevated PTH levels in XLH patients .
-METHODS	This was a prospective , randomized , placebo-controlled , double-blind , 1-year trial of paricalcitol , with outcomes measured at entry and 1 year later .
-METHODS	PATIENTS were recruited from the investigators ' clinics or referred from throughout the United States .
-METHODS	Data were collected in an in-patient hospital research unit .
-METHODS	Subjects with a clinical diagnosis of XLH and hyperparathyroidism were offered participation and were eligible if they were 9 years old or older and not pregnant , and their serum calcium level was less than 10.7 mg/dL , their 25-hydroxyvitamin D level was 20 ng/mL or greater , and their creatinine level was 1.5 mg/dL or less .
-METHODS	The intervention for this study was the use of paricalcitol or placebo for 1 year .
-METHODS	Determined prior to trial onset was the change in PTH area under the curve .
-METHODS	Secondary outcomes included renal phosphate threshold per glomerular filtration rate , serum phosphorus , serum alkaline phosphatase activity , and ( 99m ) Tc-methylenediphosphonate bone scans .
-RESULTS	PTH area under the curve decreased 17 % with paricalcitol , differing ( P = .007 ) from the 20 % increase with placebo .
-RESULTS	The renal phosphate threshold per glomerular filtration rate increased 17 % with paricalcitol and decreased 21 % with placebo ( P = .05 ) .
-RESULTS	Serum phosphorus increased 12 % with paricalcitol but did not differ from placebo .
-RESULTS	Paricalcitol decreased alkaline phosphatase activity in adults by 21 % ( no change with placebo , P = .04 ) .
-RESULTS	Bone scans improved in 6 of 17 paricalcitol subjects , whereas no placebo-treated subject improved .
-RESULTS	Hypercalciuria developed in six paricalcitol subjects and persisted from baseline in one placebo subject .
-CONCLUSIONS	Suppression of PTH may be a useful strategy for skeletal improvement in XLH patients with hyperparathyroidism , and paricalcitol appears to be an effective adjunct to standard therapy in this setting .
-CONCLUSIONS	Although paricalcitol was well tolerated , urinary calcium and serum calcium and creatinine should be monitored closely with its use .
-
-###25319187
-BACKGROUND	Whether the type of dietary fat could alter cardiometabolic responses to a hypercaloric diet is unknown .
-BACKGROUND	In addition , subclinical cardiometabolic consequences of moderate weight gain require further study .
-RESULTS	In a 7-week , double-blind , parallel-group , randomized controlled trial , 39 healthy , lean individuals ( mean age of 274 ) consumed muffins ( 51 % of energy [ % E ] from fat and 44 % E refined carbohydrates ) providing 750 kcal/day added to their habitual diets .
-RESULTS	All muffins had identical contents , except for type of fat ; sunflower oil rich in polyunsaturated fatty acids ( PUFA diet ) or palm oil rich in saturated fatty acids ( SFA diet ) .
-RESULTS	Despite comparable weight gain in the 2 groups , total : high-density lipoprotein ( HDL ) cholesterol , low-density lipoprotein : HDL cholesterol , and apolipoprotein B : AI ratios decreased during the PUFA versus the SFA diet ( -0.370.59 versus +0.070.29 , -0.310.49 versus +0.050.28 , and -0.070.11 versus +0.010.07 , P = 0.003 , P = 0.007 , and P = 0.01 for between-group differences ) , whereas no significant differences were observed for other cardiometabolic risk markers .
-RESULTS	In the whole group ( ie , independently of fat type ) , body weight increased ( +2.2 % , P < 0.001 ) together with increased plasma proinsulin ( +21 % , P = 0.007 ) , insulin ( +17 % , P = 0.003 ) , proprotein convertase subtilisin/kexin type 9 , ( +9 % , P = 0.008 ) fibroblast growth factor-21 ( +31 % , P = 0.04 ) , endothelial markers vascular cell adhesion molecule-1 , intercellular adhesion molecule-1 , and E-selectin ( +9 , +5 , and +10 % , respectively , P < 0.01 for all ) , whereas nonesterified fatty acids decreased ( -28 % , P = 0.001 ) .
-CONCLUSIONS	Excess energy from PUFA versus SFA reduces atherogenic lipoproteins .
-CONCLUSIONS	Modest weight gain in young individuals induces hyperproinsulinemia and increases biomarkers of endothelial dysfunction , effects that may be partly outweighed by the lipid-lowering effects of PUFA .
-BACKGROUND	http://ClinicalTrials.gov .
-BACKGROUND	Unique identifier : NCT01427140 .
-
-###25425394
-OBJECTIVE	To characterize the variability in exposure and metabolic effect of insulin glargine 300U/ml ( Gla-300 ) at steady state in people with type 1 diabetes ( T1DM ) .
-METHODS	A total of 50 participants with T1DM underwent two 24-h euglycaemic clamps in steady-state conditions after six once-daily administrations of 0.4 U/kg Gla-300 in a double-blind , randomized , two-treatment , two-period , crossover clamp study .
-METHODS	Participants were randomized to receive Gla-300 as a standard cartridge formulation in the first treatment period , and as a formulation with enhanced stability through polysorbate-20 addition in the second treatment period , or vice versa .
-METHODS	This design allowed the assessment of bioequivalence between formulations and , subsequently , within - and between-day variability .
-RESULTS	The cumulative exposure and effect of Gla-300 developed linearly over 24h , and were evenly distributed across 6 - and 12-h intervals .
-RESULTS	Diurnal fluctuation in exposure ( within-day variability ) was low ; the peak-to-trough ratio of insulin concentration profiles was < 2 , and both the swing and peak-to-trough fluctuation were < 1 .
-RESULTS	Day-to-day reproducibility of exposure was high : the between-day within-subject coefficients of variation for total systemic exposure ( area under the serum insulin glargine concentration time curve from time 0 to 24h after dosing ) and maximum insulin concentration were 17.4 % [ 95 % confidence interval ( CI ) 15-21 ] and 33.4 % ( 95 % CI 28-41 ) , respectively .
-RESULTS	Reproducibility of the metabolic effect was lower than that of exposure .
-CONCLUSIONS	Gla-300 provides predictable , evenly distributed 24-h coverage as a result of low fluctuation and high reproducibility in insulin exposure , and appears suitable for effective basal insulin use .
-
-###25391355
-OBJECTIVE	Echocardiography-guided ( EG ) lead placement at the site of latest left ventricular ( LV ) mechanical activation improves outcome in patients receiving a cardiac resynchronization therapy ( CRT ) defibrillator ( D ) .
-OBJECTIVE	The purpose of this study is to examine whether a strategy of EG LV lead placement equally improves outcome in CRT recipients with wide ( 150 ms ) versus intermediate ( 120-149 ms ) QRS duration .
-METHODS	Patients treated with a CRT-D in the Speckle Tracking Assisted Resynchronization Therapy for Electrode Region ( STARTER ) prospective , randomized trial ( 108 EG strategy and 75 routine strategy ) were followed to the endpoint of death or first appropriate CRT-D therapy .
-METHODS	Of the patients enrolled in STARTER , 115 had QRS150 ms and 68 had 120 < QRS149 ms.
-RESULTS	Over a mean follow-up period of 3.72.1 years , 62 ( 33 % ) patients died and 40 ( 22 % ) received appropriate CRT-D therapy .
-RESULTS	Compared to patients with QRS150 ms , patients with intermediate QRS had meaningfully worse survival free from ICD therapy ( HR = 1.48 , p = 0.056 ) .
-RESULTS	CRT-D therapy-free survival was significantly worse in patients with intermediate QRS duration randomized to the routine LV lead placement strategy , compared to patients with intermediate QRS duration randomized to the EG LV lead placement strategy or patients with wide QRS duration regardless of LV implantation strategy ( HR = 2.08 , 95 % confidence interval = 1.21-3 .56 , P = 0.008 ) .
-RESULTS	This finding was independent in type of cardiomyopathy .
-CONCLUSIONS	A strategy of EG LV lead placement improves survival free from defibrillator therapy in patients with QRS between 120-149 ms to levels comparable to those of patients with QRS150 ms.
-
-###24256677
-BACKGROUND	After traumatic brain injury ( TBI ) , catecholamines ( CAs ) may be needed to maintain adequate cerebral perfusion pressure ( CPP ) , but there are no recommended alternative vasopressor therapies .
-BACKGROUND	This is an interim report of the first study to test the hypothesis that arginine vasopressin ( AVP ) is a safe and effective alternative to CAs for the management of CPP in patients with severe TBI .
-METHODS	Since 2008 , all TBI patients requiring intracranial pressure monitoring at this Level 1 trauma center have been eligible for a randomized trial to receive either CA or AVP if vasopressors were required to maintain CPP greater than 60 mm Hg .
-RESULTS	To date , 96 patients have been consented and randomized .
-RESULTS	Demographics , vital signs , and laboratory values were similar .
-RESULTS	As treated , 60 required no vasopressors and were the least severely injured group with the best outcomes .
-RESULTS	Twenty-three patients received CA ( 70 % levophed , 22 % dopamine , 9 % phenylephrine ) and 12 patients received AVP .
-RESULTS	The two vasopressor groups had similar demographics , but Injury Severity Score ( ISS ) and fluid requirements on intensive care unit Day 1 were worse in the AVP versus the CA groups ( all p < 0.05 ) before treatment .
-RESULTS	These differences indicate more severe injury with accompanying hemodynamic instability .
-RESULTS	Nevertheless , adverse events were not increased with AVP versus CA .
-RESULTS	Trends favored AVP versus CA , but no apparent differences were statistically significant at this interim point .
-RESULTS	There was no difference in mortality rates between CA and AVP .
-CONCLUSIONS	These preliminary results suggest that AVP is a safe and effective alternative to CA for the management of CPP after TBI and support the continued investigation and use of AVP when vasopressors are required for CPP management in TBI patients .
-METHODS	Therapeutic study , level II .
-
-###24468007
-BACKGROUND	Artemisinin-based combination therapy ( ACT ) is widely recommended as first-line therapy for uncomplicated Plasmodium falciparum malaria worldwide .
-BACKGROUND	Artemisinin resistance has now been reported in Southeast Asia with a clinical phenotype manifested by slow parasite clearance .
-BACKGROUND	Although there are no reliable reports of artemisinin resistance in Africa , there is a need to better understand the dynamics of parasite clearance in African children treated with ACT in order to better detect the emergence of artemisinin resistance .
-METHODS	Data from a cohort of Ugandan children four to five years old , enrolled in a longitudinal , randomized , clinical trial comparing two leading ACT , artemether-lumefantrine ( AL ) and dihydroartemisinin-piperaquine ( DP ) , were analysed .
-METHODS	For all episodes of uncomplicated P. falciparum malaria over a 14-month period , daily blood smears were performed for three days following the initiation of therapy .
-METHODS	Associations between pre-treatment variables of interest and persistent parasitaemia were estimated using multivariate , generalized , estimating equations with adjustment for repeated measures in the same patient .
-RESULTS	A total of 202 children were included , resulting in 416 episodes of malaria treated with AL and 354 episodes treated with DP .
-RESULTS	The prevalence of parasitaemia on days 1 , 2 , and 3 following initiation of therapy was 67.6 , 5.6 and 0 % in those treated with AL , and 52.2 , 5.7 and 0.3 % in those treated with DP .
-RESULTS	Independent risk factors for persistent parasitaemia on day 1 included treatment with AL vs DP ( RR = 1.34 , 95 % CI 1.20-1 .50 , p < 0.001 ) , having a temperature 38.0 C vs < 37.0 C ( RR = 1.19 , 95 % CI 1.05-1 .35 , p = 0.007 ) and having a parasite density > 20,000 / L vs < 4,000 / L ( RR = 3.37 , 95 % CI 2.44-4 .49 , p < 0.001 ) .
-RESULTS	Independent risk factors for having persistent parasitaemia on day 2 included elevated temperature , higher parasite density , and being HIV infected .
-CONCLUSIONS	Among Ugandan children , parasite clearance following treatment with AL or DP was excellent with only one of 752 patients tested having a positive blood slide three days after initiation of therapy .
-CONCLUSIONS	The type of ACT given , pre-treatment temperature , pre-treatment parasite density and HIV status were associated with differences in persistent parasitaemia , one or two days following therapy .
-BACKGROUND	Current Controlled Trials Identifier NCT00527800 .
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-###24297663
-BACKGROUND	Understanding the nature and time course of the pharmacodynamic effects of attention-deficit/hyperactivity disorder ( ADHD ) medications is useful .
-BACKGROUND	The Cognitive Drug Research Computerized Battery of Tests ( CDR-CBT ) is a 20-min battery of ten standardized , validated neuropsychometric tasks .
-OBJECTIVE	This pilot study examined the sensitivity and responsiveness of the CDR-CBT for assessing cognitive function in adults with ADHD prior to and up to 16 h postdose during treatment with lisdexamfetamine dimesylate ( LDX ) or mixed amphetamine salts immediate release ( MAS-IR ; various generics available ) .
-METHODS	This was a double-blind three-period crossover study .
-METHODS	Participants received LDX 50 mg/day , MAS-IR 20 mg/day , and placebo ( ~ 7 a.m. ) for 7 days each in randomized order .
-METHODS	CDR-CBT was administered on day 1 of period 1 and day 7 of each period at scheduled times between -0.5 ( predose ) and 16 h postdose .
-METHODS	Composite power of attention ( PoA ) score ( sum of simple reaction time , choice reaction time , and digit vigilance speed ) was the primary outcome measure .
-METHODS	The Conners ' Adult ADHD Rating Scales-Self-Report : Short Version ( CAARS-S : S ) was administered at baseline and on day 1 of period 1 , and days 6 and 7 of each treatment period .
-METHODS	Tertiary outcomes included CDR-CBT composite continuity of attention scores , its component task scores , cognitive reaction time , and response variability scores .
-METHODS	No inferential statistical comparisons were conducted .
-METHODS	Safety assessments included adverse events ( AEs ) and vital signs .
-RESULTS	This analysis included 18 participants ( mean age 30.8 years ) ; one withdrew because of AEs .
-RESULTS	Mean pretreatment PoA scores were 1175.9-1361 .2 ms , scores commensurate with a normative age of > 40 years .
-RESULTS	Maximum reductions in PoA scores with LDX and MAS-IR occurred at 5 h postdose at day 7 ( least squares mean difference [ 95 % CI ] of -150.0 [ -235.41 to -64.50 ] and -79.8 [ -165.72 to 6.21 ] ms vs. placebo , respectively ) .
-RESULTS	CAARS-S : S scores were unchanged with LDX and MAS-IR ( vs. placebo ) at all postdose timepoints .
-RESULTS	Tertiary attention-related CDR-CBT outcomes were sensitive to LDX and MAS-IR ( vs. placebo ) .
-RESULTS	Treatment-emergent AEs and vital signs were consistent with previous studies in adult ADHD .
-CONCLUSIONS	In adults with ADHD , PoA scores indicated impaired attention at baseline and response to treatment with LDX and MAS-IR ( vs. placebo ) , demonstrating value for measuring the time course of pharmacologic treatment effects .
-
-###24865129
-OBJECTIVE	To evaluate approximal caries increment among 12 - to 16-year-olds in a low caries prevalence area in Sweden after a 3.5-year school-based fluoride ( F ) varnish programme with Bifluorid 12 and Duraphat .
-METHODS	The design was a RCT study with 1365 adolescents , divided into following four groups : Group 1 Bifluorid 12 two applications/year ; Group 2 Duraphat two applications/year ; Group 3 Bifluorid 12 four applications/year and Group 4 no F varnish at school .
-METHODS	1143 children ( 84 % ) completed the study .
-METHODS	Approximal caries was registered on bitewing radiographs .
-RESULTS	There were no statistically significant differences in caries prevalence among the groups either at baseline or after 3.5 years .
-RESULTS	The caries increment for Group 1 was 1.342.99 ( meanSD ) , 1.242.84 for Group 2 , 1.072.66 for Group 3 and 1.252.75 for Group 4 , with no statically significant differences either between Bifluorid 12 and Duraphat with the same frequency of F varnish applications or between the F groups and the control group .
-CONCLUSIONS	In an area with low caries prevalence in Sweden , the supplementary caries-preventive effect of school-based F varnish applications , to regular use of F toothpaste at home and to regular caries prevention given at the Public Dental Clinics , appears to be nonsignificant regarding approximal caries increment .
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-###25675061
-BACKGROUND	Dexmedetomidine and midazolam both modulate spinal analgesia by different mechanisms , and yet , no human studies are available to compare them for postoperative analgesia after neuraxial administration .
-OBJECTIVE	We investigated the addition of dexmedetomidine or midazolam to intrathecal bupivacaine on the duration of effective analgesia and clinical safety profile .
-METHODS	Prospective , randomized , double blind , placebo controlled study .
-METHODS	University teaching hospital .
-METHODS	The study cohort included a consecutive and prospective series of patients , referred for endourological procedures .
-METHODS	The patients were randomly allocated into 3 groups ( 20 patients each ) to receive intrathecally 3 mL of 0.5 % hyperbaric bupivacaine in combination with 5 mcg of dexmedetomidine ( dexmedetomidine group ) , 1 mg of midazolam ( midazolam group ) or 0.5 mL of 0.9 % saline ( control group ) .
-METHODS	The groups were compared to the regression time of sensory block , duration of effective analgesia ( defined as the time interval between administration of intrathecal drug to the time of first analgesic request or a numeric rating scale = 4.0 ) , sedation score , and side effects in the first 24 hours .
-METHODS	One way-ANOVA , Kruskal Wallis test , and Chi-square test ( ) , significance level : P < 0.05 .
-RESULTS	The duration of effective analgesia ( time to first analgesic request ) was significantly prolonged in the dexmedetomidine group ( 286 64 minutes , P < 0.01 ) when compared with midazolam group ( 236.9 64.9 minutes ) and the control group ( 212.7 70.2 minutes ) .
-RESULTS	Pairwise comparisons among the 3 groups with Bonferroni adjustment revealed that patients from the dexmedetomidine group were more sedated in comparison to the midazolam and control groups at the end of the first 15 minutes after intrathecal injection [ ( 2 ) = 7.157 , P = 0.028 ] , with a mean rank sedation score of 35.58 for dexmedetomidine , 25.00 for midazolam , and 30.93 for control .
-RESULTS	No significant differences in the side effects were observed during the study period .
-RESULTS	Midazolam did not lengthen the time of the two segment sensory regression or the time to first request analgesia .
-CONCLUSIONS	The study can not be extrapolated to muscle cutting surgeries under spinal anaesthesia .
-CONCLUSIONS	The addition of dexmedetomidine ( 5 mcg ) to 3 mL of intrathecal hyperbaric bupivacaine ( 0.5 % ) significantly prolongs the duration of effective analgesia in comparison to 1 mg midazolam or placebo ( 0.9 % normal saline ) with a comparable incidences of side effects .
-
-###25123170
-BACKGROUND	Several studies have presented evidence suggesting that dairy consumption has beneficial effects on blood pressure ( BP ) in healthy subjects ; however , only a few studies have examined this possibility in patients with established essential hypertension using ambulatory blood pressure monitoring .
-BACKGROUND	The objective of this study was to investigate how consuming dairy products impacts mean daytime systolic and diastolic BP in men and women with mild to moderate essential hypertension .
-METHODS	Eighty-nine men and women with systolic BP135mm Hg and160mm Hg and diastolic BP110mm Hg were enrolled in this single-blind , randomized , cross-over , controlled study .
-METHODS	Participants had to incorporate three daily servings of dairy products or control products equivalent in macronutrients and sodium during four-week treatment phases .
-METHODS	Twenty-four hour ambulatory BP and endothelial function were assessed at screening and at the end of each dietary phase .
-RESULTS	The consumption of three daily servings of dairy products led to a significant reduction in mean daytime ambulatory systolic BP ( -2 mm Hg ; P = 0.05 ) in men compared with readings after the control phase .
-RESULTS	In women , dairy consumption had no effect on ambulatory systolic BP .
-RESULTS	Moreover , endothelial function was significantly improved by dairy consumption in the whole cohort .
-CONCLUSIONS	These data indicate that the consumption of three daily servings of dairy products have beneficial effects on daytime systolic ambulatory BP compared to a heart-healthy , dairy-free , diet in men with mild to moderate essential hypertension .
-BACKGROUND	This trial is registered at clinicaltrials.gov as NCT01776216 .
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-###24576874
-OBJECTIVE	The Age-Related Eye Disease Study 1 ( AREDS 1 ) has shown that nutritional supplementation with antioxidants and zinc modifies the natural course of AMD .
-OBJECTIVE	It is presumed that the supplements exert their beneficial effects by ameliorating oxidative stress due to the scavenging of reactive oxygen species ( ROS ) .
-OBJECTIVE	We have shown in a human model that under oxidative stress induced by administration of lipopolysaccharide ( LPS ) the vasoconstrictor response of retinal vessels to oxygen breathing is diminished .
-OBJECTIVE	This reduced vascular response to hyperoxia was previously shown to be normalized by the AREDS 1 supplements .
-OBJECTIVE	In the present study , we tested the hypothesis that the response can also be restored by a different antioxidant formulation .
-METHODS	This randomized , double-masked , placebo-controlled parallel group study included 40 healthy volunteers .
-METHODS	On each study day , retinal red blood cell ( RBC ) flow and the reactivity of retinal RBC flow to hyperoxia were investigated in the absence and presence of 2 ng/kg LPS .
-METHODS	Between the two study days , subjects received either the supplement or placebo for 14 days .
-RESULTS	Before supplementation LPS reduced retinal arterial vasoconstriction ( P < 0.001 ) and reactivity of retinal RBC flow ( P = 0.03 ) in response to 100 % oxygen breathing .
-RESULTS	Two weeks of supplementation did not affect baseline retinal RBC flow , but normalized the LPS-induced change in the response to hyperoxia .
-RESULTS	The arterial vasoconstrictor response during LPS and 100 % oxygen breathing was 4.1 1.0 % after administration of placebo and 10.6 0.9 % after supplementation ( P = 0.005 ) .
-RESULTS	The response of RBC flow to 100 % oxygen breathing during LPS was 52.2 2.1 % after administration of placebo and 59.5 2.0 % after supplementation ( P = 0.033 ) .
-CONCLUSIONS	Our data show that the supplement used in the present study can normalize the response of retinal RBC flow to hyperoxia under LPS administration .
-CONCLUSIONS	This indicates that supplementation can prevent endothelial dysfunction induced by oxidative stress , which is assumed to play a role in the pathophysiology of AMD .
-CONCLUSIONS	( ClinicalTrials.gov number , NCT00914576 . )
-
-###24438561
-OBJECTIVE	The aim of this clinical study was to identify changes in pulpal blood flow ( PBF ) in human central incisors resulting from short - and long-term intrusive orthodontic forces from mini-implants .
-METHODS	A total of 40 sound upper central and lateral incisors in 20 patients scheduled for intrusion for orthodontic reasons were divided into two groups .
-METHODS	From each group , 20 teeth were subjected to intrusive force from mini-implants ( Group 1 = Light Force : 40 g ; Group 2 = Heavy Force : 120 g ) , whereas the remaining 20 contralateral teeth were not subjected to forces from mini-implants and served as controls .
-METHODS	Laser-Doppler flowmetry ( LDF ) measurements were recorded at baseline and at 3 days and 3 weeks following intrusion .
-RESULTS	PBF decreased significantly at 3 days ( Light Force Group : 7.72 0.50 ; Heavy Force Group : 7.72 0.52 ) and then increased towards baseline at 3 weeks ( Light Force Group : 10.37 0.58 ; Heavy Force Group : 10.31 0.45 ) following intrusion .
-CONCLUSIONS	In other words , despite slight regressive changes in pulpal tissue in the short-term , PBF improved after 3 weeks following intrusion by mini-implants , indicating that the changes observed in PBF is reversible , even following radical incisor intrusion .
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-###25016216
-BACKGROUND	Depression during pregnancy has been demonstrated to be predictive of low birthweight , prematurity , and postpartum depression .
-BACKGROUND	These adverse outcomes potentially have lasting effects on maternal and child well-being .
-BACKGROUND	Socio-economically disadvantaged women are twice as likely as middle-class women to meet diagnostic criteria for antenatal major depression ( MDD ) , but have proven difficult to engage and retain in treatment .
-BACKGROUND	Collaborative care treatment models for depression have not been evaluated for racially/ethnically diverse , pregnant women on Medicaid receiving care in a public health system .
-BACKGROUND	This paper describes the design , methodology , culturally relevant enhancements , and implementation of a randomized controlled trial of depression care management compared to public health Maternity Support Services ( MSS ) .
-METHODS	Pregnant , public health patients , > 18 years with a likely diagnosis of MDD or dysthymia , measured respectively by the Patient Health Questionnaire-9 ( PHQ-9 ) or the Mini-International Neuropsychiatric Interview ( MINI ) , were randomized to the intervention or to public health MSS .
-METHODS	The primary outcome was reduction in depression severity from baseline during pregnancy to 18-months post-baseline ( one-year postpartum ) .
-RESULTS	168 women with likely MDD ( 96.4 % ) and/or dysthymia ( 24.4 % ) were randomized .
-RESULTS	Average age was 27.6 years and gestational age was 22.4 weeks ; 58.3 % racial/ethnic minority ; 71.4 % unmarried ; 22 % no high school degree/GED ; 65.3 % unemployed ; 42.1 % making < $ 10,000 annually ; 80.4 % having recurrent depression ; 64.6 % PTSD , and 72 % unplanned pregnancy .
-CONCLUSIONS	A collaborative care team , including a psychiatrist , psychologist , project manager , and 3 social workers , met weekly , collaborated with the patients ' obstetrics providers , and monitored depression severity using an electronic tracking system .
-CONCLUSIONS	Potential sustainability of the intervention within a public health system requires further study .
-
-###25612789
-OBJECTIVE	This pilot trial evaluated the feasibility and safety of an early discharge strategy ( EDS : 72 h , followed by outpatient lifestyle interventions ) , in comparison with a conventional discharge strategy ( CDS ) for low-risk ( Zwolle risk score 3 ) ST-elevation myocardial infarction ( STEMI ) patients treated with primary angioplasty .
-METHODS	One hundred patients were randomized to an EDS ( n = 54 ) or a CDS ( n = 46 ) .
-METHODS	The primary end point was the feasibility of the EDS : ( 1 ) 70 % of EDS patients discharged 72 h , ( 2 ) 70 % visited by a nurse 7 days after discharge , ( 3 ) 70 % with 3 visits by the nurse and ( 4 ) 70 % visited by a cardiologist 3 months .
-RESULTS	The mean age was 59.2 12.2 years and ejection fraction 54.0 7.1 % .
-RESULTS	Eighty-six percent were male ( 12 % diabetics ) .
-RESULTS	Vascular access was radial in 91 % .
-RESULTS	Ischemic time was 4 h in 75 % .
-RESULTS	Length of stay was shorter in EDS as compared with CDS ( 70.1 8.1 vs. 111.8 28.3 h , p < 0.001 ) .
-RESULTS	EDS feasibility was : ( 1 ) 72.2 % ; ( 2 ) 81.5 % ; ( 3 ) 76.9 % ; ( 4 ) 72.2 % .
-RESULTS	There were no adverse events or differences in intervention goals and quality of life between groups .
-CONCLUSIONS	An EDS in low-risk STEMI patients is feasible and seems to be safe .
-CONCLUSIONS	A shorter hospital stay could benefit patients and health care systems .
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-###25180722
-BACKGROUND	ICU-acquired weakness ( ICU-AW ) has immediate and long-term consequences for critically ill patients .
-BACKGROUND	Strategies for the prevention of weakness include modification of known risk factors , such as hyperglycemia and immobility .
-BACKGROUND	Intensive insulin therapy ( IIT ) has been proposed to prevent critical illness polyneuropathy .
-BACKGROUND	However , the effect of insulin and early mobilization on clinically apparent weakness is not well known .
-METHODS	This is a secondary analysis of all patients with mechanical ventilation ( N = 104 ) previously enrolled in a randomized controlled trial of early occupational and physical therapy vs conventional therapy , which evaluated the end point of functional independence .
-METHODS	Every patient had IIT and blinded muscle strength testing on hospital discharge to determine the incidence of clinically apparent weakness .
-METHODS	The effects of insulin dose and early mobilization on the incidence of ICU-AW were assessed .
-RESULTS	On logistic regression analyses , early mobilization and increasing insulin dose prevented the incidence of ICU-AW ( OR , 0.18 , P = .001 ; OR , 0.001 , P = .011 ; respectively ) independent of known risk factors for weakness .
-RESULTS	Early mobilization also significantly reduced insulin requirements to achieve similar glycemic goals as compared with control patients ( 0.07 units/kg/d vs 0.2 units/kg/d , P < .001 ) .
-CONCLUSIONS	The duel effect of early mobilization in reducing clinically relevant ICU-AW and promoting euglycemia suggests its potential usefulness as an alternative to IIT .
-
-###25736340
-BACKGROUND	The prevalence of chronic diseases such as type 2 diabetes and chronic low back pain is rising .
-BACKGROUND	Patient empowerment is a key strategy in the management of chronic diseases .
-BACKGROUND	Patient empowerment can be fostered by Web-based interactive health communication applications ( IHCAs ) that combine health information with decision support , social support , and/or behavioral change support .
-BACKGROUND	Tailoring the content and tone of IHCAs to the needs of individual patients might improve their effectiveness .
-OBJECTIVE	The main objective was to test the effectiveness of a Web-based , tailored , fully automated IHCA for patients with type 2 diabetes or chronic low back pain against a standard website with identical content without tailoring ( control condition ) on patients ' knowledge and empowerment .
-METHODS	We performed a blinded randomized trial with a parallel design .
-METHODS	In the intervention group , the content was delivered in dialogue form , tailored to relevant patient characteristics .
-METHODS	In the control group , the sections of the text were presented in a content tree without any tailoring .
-METHODS	Participants were recruited online and offline and were blinded to their group assignments .
-METHODS	Measurements were taken at baseline ( t0 ) , directly after the first visit ( t1 ) , and at 3-month follow-up ( t2 ) .
-METHODS	The primary hypothesis was that the tailored IHCA would have larger effects on knowledge and patient empowerment ( primary outcomes ) than the control website .
-METHODS	The secondary outcomes were decisional conflict and preparation for decision making .
-METHODS	All measurements were conducted by online self-report questionnaires .
-METHODS	Intention-to-treat ( ITT ) and available cases ( AC ) analyses were performed for all outcomes .
-RESULTS	A total of 561 users agreed to participate in the study .
-RESULTS	Of these , 179 ( 31.9 % ) had type 2 diabetes and 382 ( 68.1 % ) had chronic low back pain .
-RESULTS	Usage was significantly higher in the tailored system ( mean 51.2 minutes ) than in the control system ( mean 37.6 minutes ; P < .001 ) .
-RESULTS	Three months after system use , 52.4 % of the sample was retained .
-RESULTS	There was no significant intervention effect in the ITT analysis .
-RESULTS	In the AC analysis , participants using the tailored system displayed significantly more knowledge at t1 ( P = .02 ) and more emotional well-being ( subscale of empowerment ) at t2 ( P = .009 ) .
-RESULTS	The estimated mean difference between the groups was 3.9 ( 95 % CI 0.5-7 .3 ) points for knowledge and 25.4 ( 95 % CI 6.3-44 .5 ) points for emotional well-being on a 0-100 points scale .
-CONCLUSIONS	The primary analysis did not support the study hypothesis .
-CONCLUSIONS	However , content tailoring and interactivity may increase knowledge and reduce health-related negative effects in persons who use IHCAs .
-CONCLUSIONS	There were no main effects of the intervention on other dimensions of patient empowerment or decision-related outcomes .
-CONCLUSIONS	This might be due to our tailored IHCA being , at its core , an educational intervention offering health information in a personalized , empathic fashion that merely additionally provides decision support .
-CONCLUSIONS	Tailoring and interactivity may not make a difference with regard to these outcomes .
-BACKGROUND	International Clinical Trials Registry : DRKS00003322 ; http://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00003322 ( Archived by WebCite at http://www.webcitation.org/6WPO0lJwE ) .
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-###24370797
-OBJECTIVE	In this study , we tested the hypothesis that pulmonary artery venting would decrease the incidence of atrial fibrillation after coronary artery bypass surgery .
-METHODS	This prospective study included 301 patients who underwent complete myocardial revascularization with cardiopulmonary bypass in our department during a 2-year period .
-METHODS	The patients were randomly divided into 2 groups : group I included 151 patients who underwent aortic root venting and group II included 150 patients who underwent pulmonary arterial venting for decompression of the left heart .
-METHODS	Pre - , peri - , and postoperative risk factors for atrial fibrillation were assessed in both groups .
-RESULTS	The mean age was similar in the 2 groups .
-RESULTS	The mean number of anastomoses was significantly higher in group I ( 2.8 0.8 ) than in group II ( 2.4 0.8 ) ( P = 0.001 ) .
-RESULTS	The mean cross-clamp time was 42.7 17.4 minutes in group I and 54.1 23.8 minutes in group II ( P = 0.001 ) .
-RESULTS	The mean cardiopulmonary bypass time was 66.4 46.1 minutes in group I and 77.4 28.6 minutes in group II ( P = 0.08 ) .
-RESULTS	The incidence of atrial fibrillation was 14.5 % ( n = 21 ) in group I and 6.5 % ( n = 10 ) in group II ( P = 0.02 ) .
-RESULTS	Multivariate regression analysis showed that pulmonary artery venting decreased the postoperative incidence of atrial fibrillation by 17.6 % .
-CONCLUSIONS	Pulmonary arterial venting may be used as an alternative to aortic root venting during on-pump coronary bypass surgery , especially in patients at high risk of postoperative atrial fibrillation .
-
-###24521647
-OBJECTIVE	Biapenem is a newly developed carbapenem to treat moderate and severe bacterial infections .
-OBJECTIVE	This multicenter , randomized , parallel-controlled clinical trial was conducted to compare the clinical efficacy , bacterial eradication rates and safety of biapenem and meropenem in the treatment of bacterial lower respiratory tract infections and urinary tract infections ( UTIs ) at nine centres in China .
-METHODS	Patients diagnosed with bacterial lower respiratory tract infections or UTIs were randomly assigned to receive either biapenem ( 300 mg every 12 h ) or meropenem ( 500 mg every 8 h ) by intravenous infusion for 7 to 14 days according to their disease severity .
-METHODS	The overall clinical efficacy , bacterial eradication rates and drug-related adverse reactions of biapenem and meropenem were analyzed .
-RESULTS	A total of 272 enrolled cases were included in the intent-to-treat ( ITT ) analysis and safety analysis .
-RESULTS	There were no differences in demographics and baseline medical characteristics between biapenem group and meropenem group .
-RESULTS	The overall clinical efficacies of biapenem and meropenem were not significantly different , 94.70 per cent ( 125/132 ) vs. 93.94 per cent ( 124/132 ) .
-RESULTS	The overall bacterial eradication rates of biapenem and meropenem showed no significant difference , 96.39 per cent ( 80/83 ) vs. 93.75 per cent ( 75/80 ) .
-RESULTS	Drug-related adverse reactions were comparable in biapenem and meropenem groups with the incidence of 11.76 per cent ( 16/136 ) and 15.44 per cent ( 21/136 ) , respectively .
-RESULTS	The most common symptoms of biapenem-related adverse reactions were rash ( 2.2 % ) and gastrointestinal distress ( 1.5 % ) .
-CONCLUSIONS	Biapenem was non-inferior to meropenem and was well-tolerated in the treatment of moderate and severe lower respiratory tract infections and UTIs .
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-###24666767
-BACKGROUND	Early negative postoperative behavior ( e-PONB ) is common in children and manifests itself as emergence agitation ( EA ) , emergence delirium ( ED ) , and pain .
-BACKGROUND	The objective of this prospective double blind , randomized , placebo-controlled trial was to determine whether IV clonidine or IV fentanyl prior to surgery modifies e-PONB in children .
-METHODS	Ninety children scheduled for subumbilical surgery under sevoflurane anesthesia supplemented with regional anesthesia were randomized to either receive IV clonidine 2mcgkg ( -1 ) , IV fentanyl 2mcgkg ( -1 ) or placebo ( IV saline ) before surgery .
-METHODS	Primary outcome measures were the incidence of EA , ED and pain during the first hour after awakening .
-METHODS	Secondary outcome measures were side effects such as nausea and vomiting and delayed discharge from PACU .
-RESULTS	Eighty-seven children ( n = 29 per group ) completed the study .
-RESULTS	EA was present in 10 children ( six clonidine , none fentanyl , and four placebo , P = 0.04 ) whereas ED was observed in 20 children ( nine clonidine , three fentanyl , and eight placebo P = 0.13 ) .
-RESULTS	Sixteen children who received placebo had a CHIPPS score of 4 compared with nine children in fentanyl group and 18 children receiving clonidine ( P = 0.04 ) .
-RESULTS	Ten children receiving fentanyl vomited during the first postoperative day , compared with six children in placebo group and none in clonidine group ( P = 0.003 ) .
-RESULTS	Discharge from PACU was not affected .
-CONCLUSIONS	IV fentanyl before surgery but not IV clonidine modifies e-PONB in children undergoing lower abdominal surgery under general anesthesia supplemented with regional anesthesia .
-CONCLUSIONS	The use of fentanyl in this population was also associated with reduced pain scores after awakening but with significantly greater incidence of PONV .
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-###25060683
-BACKGROUND	Although pain is a common complication of endoscopic submucosal dissection ( ESD ) , management strategies are inadequate .
-BACKGROUND	The aim of this study was to evaluate the efficacy of topical bupivacaine and triamcinolone acetonide for abdominal pain relief and as a potential method of pain control after ESD for gastric neoplasia .
-METHODS	In this randomized , double-blind , placebo-controlled trial , 111 eligible patients with early gastric neoplasm were randomized into one of three groups : bupivacaine ( BV ) only , bupivacaine with triamcinolone ( BV-TA ) , or placebo .
-METHODS	The present pain intensity ( PPI ) score and the Short-Form McGill Pain Questionnaire ( SF-MPQ ) were used to evaluate pain at 0 , 6 , 12 , and 24 h after ESD .
-RESULTS	The mean values for the 6-hour PPI in the BV-TA and BV groups were lower than those of the placebo group ( 1.57 1.09 and 1.97 1.09 vs. 2.63 0.98 , p < 0.001 ) .
-RESULTS	The 12-hour PPI of the BV-TA group ( 1.20 0.83 ) was the lowest among the three groups ( p = 0.001 ) .
-RESULTS	The total 6-hour SF-MPQ score , especially in the sensory domain , was higher in the placebo group than in BV and BV-TA groups .
-RESULTS	The 12-hour SF-MPQ score was the lowest in the BV-TA group .
-RESULTS	Multivariate analysis demonstrated that BV-TA injection protocol , fibrosis , and size of residual ulcer were independently associated with the PPI score at 6 h.
-CONCLUSIONS	Bupivacaine after ESD was effective for pain relief at 6 h postoperatively .
-CONCLUSIONS	Particularly , topical infiltration of bupivacaine mixed with triamcinolone acetonide was helpful for producing a more long-lasting benefit of pain relief after gastric ESD .
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-###24731832
-OBJECTIVE	Physical activity is a cornerstone in therapy for patients with metabolic syndrome .
-OBJECTIVE	Walking and hiking in a mountain scenery represents an ideal approach to make them move .
-OBJECTIVE	The Austrian Moderate Altitude Study ( AMAS ) 2000 main study is a randomized controlled trial to investigate the cardiovascular effects of hiking at moderate altitude on patients with metabolic syndrome compared with a control group at low altitude , to assess a potential altitude-specific effect .
-METHODS	Seventy-one male patients with metabolic syndrome were randomly assigned to a moderate altitude group ( at 1700 m ) , with 36 participants , or to a low altitude group ( at 200 m ) , with 35 participants .
-METHODS	The 3-week vacation program included 12 hiking tours ( 4 per week , average duration 2.5 hours , intensity 55 % to 65 % of heart rate maximum ) .
-METHODS	Physical parameters , performance capacity , 24-hour blood pressure , and heart rate profiles were obtained before , during , and after the stay .
-RESULTS	In both groups , we found a significant mean weight loss of -3.13 kg ; changes in performance capacity were minor .
-RESULTS	Systolic , diastolic , and mean arterial pressures and circadian heart rate profiles were significantly reduced in both groups , with no differences between them .
-RESULTS	Consequently , the pressure-rate product was reduced as well .
-RESULTS	All study participants tolerated the vacation well without any adverse events .
-CONCLUSIONS	A 3-week hiking vacation at moderate or low altitude is safe for patients with metabolic syndrome and provides several improvements in their cardiovascular parameters .
-CONCLUSIONS	The cardiovascular benefits achieved are more likely to be the result of regular physical activity than the altitude-specific effect of a mountain environment .
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-###25144818
-BACKGROUND	Isolated limb perfusion ( ILP ) is a treatment option most commonly used in the treatment of melanoma in-transit metastases of the extremities .
-BACKGROUND	The principle idea is to surgically isolate a region of the body and then deliver a high concentration of a chemotherapeutic agent together with hyperthermia .
-BACKGROUND	There have been three randomised trials exploring whether adjuvant ILP to patients with recurrent or high-risk primary melanomas increases survival ; one of these trials has now been updated with a 25-year follow-up .
-METHODS	The original study randomised 69 patients ( between 1981 and 1989 ) with their first satellite or in-transit recurrence to either wide excision ( WE group , n = 36 patients ) or to WE and adjuvant ILP ( WE+ILP group , n = 33 patients ) .
-METHODS	Follow-up data 25 years later concerning survival and cause of death was retrieved from the Swedish National Cause of Death Register .
-RESULTS	In the WE+ILP group there were 20 deaths ( 61 % ) due to melanoma compared with 26 deaths ( 72 % ) in the WE group ( p = 0.31 ) .
-RESULTS	Median melanoma-specific survival was 95 months for WE+ILP compared to 38 months for the WE group , an almost 5 year benefit without statistical significance ( p = 0.24 ) .
-CONCLUSIONS	There is no evidence that adjuvant ILP prolongs survival in patients with high-risk or recurrent melanoma ; however , the existing randomised trials are largely underpowered to detect such a difference .
-CONCLUSIONS	New studies are exploring systemic immunological effects of ILP , and a combination of regional therapy and immunotherapy may serve as a rationale for new trials using ILP in the future .
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-###25491243
-BACKGROUND	Automated health behavior change interventions show promise , but suffer from high attrition and disuse .
-BACKGROUND	The Internet abounds with thousands of personal narrative accounts of health behavior change that could not only provide useful information and motivation for others who are also trying to change , but an endless source of novel , entertaining stories that may keep participants more engaged than messages authored by interventionists .
-OBJECTIVE	Given a collection of relevant personal health behavior change stories gathered from the Internet , the aim of this study was to develop and evaluate an automated indexing algorithm that could select the best possible story to provide to a user to have the greatest possible impact on their attitudes toward changing a targeted health behavior , in this case weight loss .
-METHODS	An indexing algorithm was developed using features informed by theories from behavioral medicine together with text classification and machine learning techniques .
-METHODS	The algorithm was trained using a crowdsourced dataset , then evaluated in a 22 between-subjects randomized pilot study .
-METHODS	One factor compared the effects of participants reading 2 indexed stories vs 2 randomly selected stories , whereas the second factor compared the medium used to tell the stories : text or animated conversational agent .
-METHODS	Outcome measures included changes in self-efficacy and decisional balance for weight loss before and after the stories were read .
-RESULTS	Participants were recruited from a crowdsourcing website ( N = 103 ; 53.4 % , 55/103 female ; mean age 35 , SD 10.8 years ; 65.0 % , 67/103 precontemplation ; 19.4 % , 20/103 contemplation for weight loss ) .
-RESULTS	Participants who read indexed stories exhibited a significantly greater increase in self-efficacy for weight loss compared to the control group ( F1 ,107 = 5.5 , P = .02 ) .
-RESULTS	There were no significant effects of indexing on change in decisional balance ( F1 ,97 = 0.05 , P = .83 ) and no significant effects of medium on change in self-efficacy ( F1 ,107 = 0.04 , P = .84 ) or decisional balance ( F1 ,97 = 0.78 , P = .38 ) .
-CONCLUSIONS	Personal stories of health behavior change can be harvested from the Internet and used directly and automatically in interventions to affect participant attitudes , such as self-efficacy for changing behavior .
-CONCLUSIONS	Such approaches have the potential to provide highly tailored interventions that maximize engagement and retention with minimal intervention development effort .
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-###24429275
-BACKGROUND	Many patients with asthma or chronic obstructive pulmonary disease ( COPD ) routinely receive a combination of an inhaled bronchodilator and anti-inflammatory glucocorticosteroid , but those with severe disease often respond poorly to these classes of drug .
-BACKGROUND	We assessed the efficacy and safety of a novel inhaled dual phosphodiesterase 3 ( PDE3 ) and PDE4 inhibitor , RPL554 for its ability to act as a bronchodilator and anti-inflammatory drug .
-METHODS	Between February , 2009 , and January , 2013 , we undertook four proof-of-concept clinical trials in the Netherlands , Italy , and the UK .
-METHODS	Nebulised RPL554 was examined in study 1 for safety in 18 healthy men who were randomly assigned ( 1:1:1 ) to receive an inhaled dose of RPL554 ( 0003 mg/kg or 0009 mg/kg ) or placebo by a computer-generated randomisation table .
-METHODS	Subsequently , six non-smoking men with mild allergic asthma received single doses of RPL554 ( three received 0009 mg/kg and three received 0018 mg/kg ) in an open-label , adaptive study , and then ten men with mild allergic asthma were randomly assigned to receive placebo or RPL554 ( 0018 mg/kg ) by a computer-generated randomisation table for an assessment of safety , bronchodilation , and bronchoprotection .
-METHODS	Study 2 examined the reproducibility of the bronchodilator response to a daily dose of nebulised RPL554 ( 0018 mg/kg ) for 6 consecutive days in a single-blind ( patients masked ) , placebo-controlled study in 12 men with clinically stable asthma .
-METHODS	The safety and bronchodilator effect of RPL554 ( 0018 mg/kg ) was assessed in study 3 , an open-label , placebo-controlled crossover trial , in 12 men with mild-to-moderate COPD .
-METHODS	In study 4 , a placebo-controlled crossover trial , the effect of RPL554 ( 0018 mg/kg ) on lipopolysaccharide-induced inflammatory cell infiltration in induced sputum was investigated in 21 healthy men .
-METHODS	In studies 3 and 4 , randomisation was done by computer-generated permutation with a block size of two for study 3 and four for study 4 .
-METHODS	Unless otherwise stated , participants and clinicians were masked to treatment assignment .
-METHODS	Analyses were by intention to treat .
-METHODS	All trials were registered with EudraCT , numbers 2008-005048-17 , 2011-001698-22 , 2010-023573-18 , and 2012-000742-34 .
-RESULTS	Safety was a primary endpoint of studies 1 and 3 and a secondary endpoint of studies 2 and 4 .
-RESULTS	Overall , RPL554 was well tolerated , and adverse events were generally mild and of equal frequency between placebo and active treatment groups .
-RESULTS	Efficacy was a primary endpoint of study 2 and a secondary endpoint of studies 1 and 3 .
-RESULTS	Study 1 measured change in forced expiratory volume in 1 s ( FEV1 ) and provocative concentration of methacholine causing a 20 % fall in FEV1 ( PC20MCh ) in participants with asthma .
-RESULTS	RPL554 produced rapid bronchodilation in patients with asthma with an FEV1 increase at 1 h of 520 mL ( 95 % CI 320-720 ; p < 00001 ) , which was a 14 % increase from placebo , and increased the PC20MCh by 15 doubling doses ( 95 % CI 063-228 ; p = 0004 ) compared with placebo .
-RESULTS	The primary endpoint of study 2 was maximum FEV1 reached during 6 h after dosing with RPL554 in patients with asthma .
-RESULTS	RPL554 produced a similar maximum mean increase in FEV1 from placebo on day 1 ( 555 mL , 95 % CI 442-668 ) , day 3 ( 505 mL , 392-618 ) , and day 6 ( 485 mL , 371-598 ; overall p < 00001 ) .
-RESULTS	A secondary endpoint of study 3 ( patients with COPD ) was the increase from baseline in FEV1 .
-RESULTS	RPL554 produced bronchodilation with a mean maximum FEV1 increase of 172 % ( SE 52 ) .
-RESULTS	In healthy individuals ( study 4 ) , the primary endpoint was percentage change in neutrophil counts in induced sputum 6 h after lipopolysaccharide challenge .
-RESULTS	RPL554 ( 0018 mg/kg ) did not significantly reduce the percentage of neutrophils in sputum ( 803 % in the RPL554 group vs 842 % in the placebo group ; difference -39 % , 95 % CI -94 to 16 , p = 015 ) , since RPL554 significantly reduced neutrophils ( p = 0002 ) and total cells ( p = 0002 ) to a similar degree .
-CONCLUSIONS	In four exploratory studies , inhaled RPL554 is an effective and well tolerated bronchodilator , bronchoprotector , and anti-inflammatory drug and further studies will establish the full potential of this new drug for the treatment of patients with COPD or asthma .
-BACKGROUND	Verona Pharma .
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-###24447053
-OBJECTIVE	Intensified repetitive transcranial magnetic stimulation ( rTMS ) applied to the left dorsolateral prefrontal cortex ( DLPFC ) may result in fast clinical responses in treatment resistant depression ( TRD ) .
-OBJECTIVE	In these kinds of patients , subgenual anterior cingulate cortex ( sgACC ) functional connectivity ( FC ) seems to be consistently disturbed .
-OBJECTIVE	So far , no de novo data on the relationship between sgACC FC changes and clinical efficacy of accelerated rTMS were available .
-METHODS	Twenty unipolar TRD patients , all at least stage III treatment resistant , were recruited in a randomized sham-controlled crossover high-frequency ( HF ) - rTMS treatment study .
-METHODS	Resting-state ( rs ) functional MRI scans were collected at baseline and at the end of treatment .
-RESULTS	HF-rTMS responders showed significantly stronger resting-state functional connectivity ( rsFC ) anti-correlation between the sgACC and parts of the left superior medial prefrontal cortex .
-RESULTS	After successful treatment an inverted relative strength of the anti-correlations was observed in the perigenual prefrontal cortex ( pgPFC ) .
-RESULTS	No effects on sgACC rsFC were observed in non-responders .
-CONCLUSIONS	Strong rsFC anti-correlation between the sgACC and parts of the left prefrontal cortex could be indicative of a beneficial outcome .
-CONCLUSIONS	Accelerated HF-rTMS treatment designs have the potential to acutely adjust deregulated sgACC neuronal networks in TRD patients .
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-###25428445
-BACKGROUND	Screening Tool of Older Person 's Prescriptions ( STOPP ) and the Screening Tool to Alert doctors to Right Treatment ( START ) have been increasingly used to evaluate potentially inappropriate prescriptions ( PIPs ) and potentially prescription omissions ( PPOs ) .
-BACKGROUND	The impact of hospitalization on PIPs/PPOs has not been investigated in depth .
-OBJECTIVE	To compare the prevalence of PIPs/PPOs in elderly patients on hospital admission and discharge and to identify associated risk factors .
-METHODS	An acute medical geriatric division of the Tel Aviv Medical Center ( Israel ) .
-METHODS	This retrospective cross-sectional study included patients admitted from 12/2011 to 12/2012 aged 65 years .
-METHODS	Data from patients ' records included demographic details , diagnoses and medications at admission and discharge .
-METHODS	STOPP/START criteria were applied to each patient 's record .
-METHODS	Prevalence of PIPs/PPOs on hospital admission and discharge .
-RESULTS	Three hundred patients were included ( mean SD age 81.9 7.2 years ) .
-RESULTS	Admission PIPs prevalence was 39.3 % ( 118 patients , 172 PIPs ) and it increased to 46.0 % ( 138 patients , 209 PIPs ) at discharge ( P = 0.009 ) .
-RESULTS	Admission PPOs prevalence was 41.0 % ( 123 patients , 153 PPOs ) and it decreased to 28.3 % ( 85 patients , 99 PPOs ) at discharge ( P < 0.001 ) .
-RESULTS	Having at least one PIP/PPO at discharge but not at admission was associated with length of hospital stay ( OR 1.02 , 95 % CI 1.001-1 .03 ) .
-RESULTS	History of falls increased the risk of being a `` new PIP patient '' ( OR 2.25 , 95 % CI 1.03-4 .9 ) , whereas diabetes increased the risk of being a `` new PPO patient '' ( OR 3.86 , 95 % CI 1.2-12 .5 ) .
-CONCLUSIONS	Hospitalization in a geriatric division resulted in an increase in PIPs and a decrease in PPOs .
-CONCLUSIONS	Strategies to reduce PIPs need to be implemented , especially for patients with longer hospital stay and a history of falls .
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-###25208597
-OBJECTIVE	Tadalafil is a potent and selective phosphodiesterase type 5 inhibitor that provides effective treatment for erectile dysfunction ( ED ) .
-OBJECTIVE	The purpose of this study was to explore the effect of a single on-demand dose of tadalafil compared to low-dose continuous administration on regional cerebral blood flow ( rCBF ) , in patients after stroke .
-METHODS	Thirty consecutive male patients ( mean age 58.3 7.9 years ) with ED and a history of stroke were included in the study .
-METHODS	The baseline single-photon emission computed tomography ( SPECT ) study was performed 15 min after iv injection of 740 MBq Tc-99m-HMPAO ( Ceretec ; GE Healthcare Ltd. .
-METHODS	Chalfont St. Giles , UK ) .
-METHODS	Fifteen randomized patients received a single dose of 20 mg tadalafil in the morning , and a second SPECT study was performed 6 h later .
-METHODS	Fifteen other patients received 5 mg of tadalafil each morning for seven consecutive days , and the second SPECT study was performed 6 h after the last dose .
-METHODS	The imaging data were evaluated using SPM software ( Wellcome Department of Cognitive Neurology , University College , London ) .
-RESULTS	Associations between any of the risk factors/comorbidities and the perfusion changes were not detected .
-RESULTS	All patients showed areas of reduced relative rCBF in the affected hemisphere after tadalafil administration compared to baseline ( P < 0.001 ) .
-RESULTS	No significant difference was found between patients on 5 mg tadalafil and 20 mg dose .
-CONCLUSIONS	Tadalafil administration after cerebral stroke may be associated with diminished blood flow to areas adjacent to the stroke .
-CONCLUSIONS	The alterations in perfusion suggest a need for caution in prescribing tadalafil to patients with a history of stroke , especially with continuous administration that may impose constant stress on the cerebral circulation .
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-###24732169
-OBJECTIVE	To investigate the short-term effect of a mixed Kinesio taping ( KT ) model on range of ankle motion ( ROAM ) , gait , pain , perimeter of lower limbs , and quality of life in postmenopausal women with chronic venous insufficiency ( CVI ) .
-METHODS	Double-blinded , randomized controlled trial .
-METHODS	Clinical setting .
-METHODS	Consecutive postmenopausal women ( N = 130 ; mean age SD , 65.4414.7 y ) with mild CVI .
-METHODS	No participant withdrew because of adverse effects .
-METHODS	Participants were randomly assigned to either ( 1 ) an experimental group to receive a mixed KT-compression treatment following KT recommendations for gastrocnemius muscle enhancement and functional correction of the ankle , and adding 2 tapes to simulate traditional compression bandages ( no KT guidelines ) ; or ( 2 ) a placebo control group for sham KT .
-METHODS	Both interventions were performed 3 times a week during a 4-week period .
-METHODS	ROAM , gait , pain , perimeter of right and left lower limb , and quality of life were assessed at baseline and 48 hours posttreatment .
-RESULTS	Quality of life was better in the intervention group by a mean of 8.76 points ( 95 % confidence interval [ CI ] , 4.96-12 .55 ) .
-RESULTS	The experimental group also showed significant pre - / posttreatment improvements in both lower limbs in gait dorsiflexion ROAM ( 95 % CI , 1.02-2 .49 ) , cadence ( 95 % CI , 3.45-1 .47 ) , stride length ( 95 % CI , 21.48-10 .83 ) , step length ( 95 % CI , 1.68-6 .61 ) , stance phase ( 95 % CI , 61-107 ) , and foot ( 95 % CI , .56 -.92 ) and malleolus ( 95 % CI , 1.15-1 .63 ) circumference .
-RESULTS	None of these variables were significantly modified in the placebo group .
-RESULTS	Both groups reported a significant reduction in pain .
-CONCLUSIONS	Ankle dorsiflexion during gait , walking parameters , peripheral edema , venous pain , and quality of life remain improved in patients with CVI at 1 month after mixed KT-compression therapy .
-CONCLUSIONS	KT may have a placebo effect on pain perception .
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-###24275909
-OBJECTIVE	The authors compared psychoanalytic psychotherapy and cognitive-behavioral therapy ( CBT ) in the treatment of bulimia nervosa .
-METHODS	A randomized controlled trial was conducted in which 70 patients with bulimia nervosa received either 2 years of weekly psychoanalytic psychotherapy or 20 sessions of CBT over 5 months .
-METHODS	The main outcome measure was the Eating Disorder Examination interview , which was administered blind to treatment condition at baseline , after 5 months , and after 2 years .
-METHODS	The primary outcome analyses were conducted using logistic regression analysis .
-RESULTS	Both treatments resulted in improvement , but a marked difference was observed between CBT and psychoanalytic psychotherapy .
-RESULTS	After 5 months , 42 % of patients in CBT ( N = 36 ) and 6 % of patients in psychoanalytic psychotherapy ( N = 34 ) had stopped binge eating and purging ( odds ratio = 13.40 , 95 % confidence interval [ CI ] = 2.45-73 .42 ; p < 0.01 ) .
-RESULTS	At 2 years , 44 % in the CBT group and 15 % in the psychoanalytic psychotherapy group had stopped binge eating and purging ( odds ratio = 4.34 , 95 % CI = 1.33-14 .21 ; p = 0.02 ) .
-RESULTS	By the end of both treatments , substantial improvements in eating disorder features and general psychopathology were observed , but in general these changes took place more rapidly in CBT .
-CONCLUSIONS	Despite the marked disparity in the number of treatment sessions and the duration of treatment , CBT was more effective in relieving binging and purging than psychoanalytic psychotherapy and was generally faster in alleviating eating disorder features and general psychopathology .
-CONCLUSIONS	The findings indicate the need to develop and test a more structured and symptom-focused version of psychoanalytic psychotherapy for bulimia nervosa .
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-###25369857
-BACKGROUND	Tobacco smoking prevalence continues to be high , particularly among adolescents and young adults with lower educational levels , and is therefore a serious public health problem .
-BACKGROUND	Tobacco smoking and problem drinking often co-occur and relapses after successful smoking cessation are often associated with alcohol use .
-BACKGROUND	This study aims at testing the efficacy of an integrated smoking cessation and alcohol intervention by comparing it to a smoking cessation only intervention for young people , delivered via the Internet and mobile phone .
-METHODS	A two-arm cluster-randomised controlled trial with one follow-up assessment after 6months will be conducted .
-METHODS	Participants in the integrated intervention group will : ( 1 ) receive individually tailored web-based feedback on their drinking behaviour based on age and gender norms , ( 2 ) receive individually tailored mobile phone text messages to promote drinking within low-risk limits over a 3-month period , ( 3 ) receive individually tailored mobile phone text messages to support smoking cessation for 3months , and ( 4 ) be offered the option of registering for a more intensive program that provides strategies for smoking cessation centred around a self-defined quit date .
-METHODS	Participants in the smoking cessation only intervention group will only receive components ( 3 ) and ( 4 ) .
-METHODS	Study participants will be 1350 students who smoke tobacco daily/occasionally , from vocational schools in Switzerland .
-METHODS	Main outcome criteria are 7-day point prevalence smoking abstinence and cigarette consumption assessed at the 6-month follow up .
-CONCLUSIONS	This is the first study testing a fully automated intervention for smoking cessation that simultaneously addresses alcohol use and interrelations between tobacco and alcohol use .
-CONCLUSIONS	The integrated intervention can be easily implemented in various settings and could be used with large groups of young people in a cost-effective way .
-BACKGROUND	Current Controlled Trials ISRCTN02427446 ( date of registration : 08th September , 2014 ) .
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-###25217473
-OBJECTIVE	To investigate the effect of intranasal ketamine versus alfentanil in addition to oral midazolam for the prevention of emergence agitation in children .
-METHODS	Children undergoing urological surgery with sevoflurane anaesthesia received oral midazolam 40 min before induction and were then randomly assigned to receive 2 mg/kg ketamine , 10 g/kg alfentanil or 1 ml isotonic saline intranasally .
-METHODS	Parental separation status and mask acceptance were assessed preoperatively .
-METHODS	Emergence agitation was evaluated using a paediatric anaesthesia emergence delirium ( PAED ) score .
-RESULTS	Data from 78 children were evaluated in the study .
-RESULTS	There were no significant differences between the groups in demographic characteristics , recovery times or parental separation scores .
-RESULTS	Mask acceptance was significantly better in the ketamine group than in the saline group .
-RESULTS	The mean PAED score in the ketamine group was significantly better than in the other two groups , but was similar in the saline and alfentanil groups .
-RESULTS	The incidence of emergence agitation was 3.8 % , 36.0 % and 40.7 % in the ketamine , alfentanil and saline groups , respectively .
-CONCLUSIONS	The addition of intranasal ketamine to oral midazolam significantly improved the quality of induction and reduced sevoflurane-induced emergence agitation , in children undergoing urological surgery .
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-###26075372
-OBJECTIVE	The aim of this study was to examine the effect of chitosan membrane on wound healing .
-METHODS	The effect of chitosan membranes was evaluated in an experimental rat model .
-METHODS	On day 0 , circular full-thickness skin sections were excised from the scalps of rats .
-METHODS	The wounds were then measured and the surrounding area tattooed .
-METHODS	Rats were sacrificed either immediately after excision , or randomised into control and chitosan groups and followed up on day 3 , 7 , 14 or 21 .
-METHODS	Control group wounds were covered with Aquacel ( wound dressing ) .
-METHODS	Chitosan group wounds were covered with chitosan membranes and the wound dressing .
-METHODS	Wounds and the distances between the tattooed marks were measured on follow-up , the wound sites were harvested and histologically examined , and serum interleukin ( IL-4 ) levels were analysed .
-RESULTS	A total of 54 rats were examined and all time points included 6 control and 6 chitosan treated animals , except for day 0 which consisted of control animals only .
-RESULTS	On day 3 , wounds in the chitosan group were significantly ( p < 0.05 ) smaller ( 606 % versus 7819 % of the original wound area ) than in the control group .
-RESULTS	Chitosan membranes were found to degrade at the wound sites between days 7 and 14 .
-RESULTS	Leukocyte counts were lower in the chitosan group than in the control group on day seven ( p < 0.05 ) .
-RESULTS	IL-4 levels were significantly higher on day 7 ( p < 0.001 ) and 14 ( p < 0.001 ) in the chitosan group .
-CONCLUSIONS	According to our results chitosan membrane may promote early wound healing , reduce inflammation and affect the IL-4 pathway , however , the membrane degrades at the wound site after day 7 .
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-###25738669
-BACKGROUND	The treatment of symptomatic congenital cytomegalovirus ( CMV ) disease with intravenous ganciclovir for 6 weeks has been shown to improve audiologic outcomes at 6 months , but the benefits wane over time .
-METHODS	We conducted a randomized , placebo-controlled trial of valganciclovir therapy in neonates with symptomatic congenital CMV disease , comparing 6 months of therapy with 6 weeks of therapy .
-METHODS	The primary end point was the change in hearing in the better ear ( `` best-ear '' hearing ) from baseline to 6 months .
-METHODS	Secondary end points included the change in hearing from baseline to follow-up at 12 and 24 months and neurodevelopmental outcomes , with each end point adjusted for central nervous system involvement at baseline .
-RESULTS	A total of 96 neonates underwent randomization , of whom 86 had follow-up data at 6 months that could be evaluated .
-RESULTS	Best-ear hearing at 6 months was similar in the 6-month group and the 6-week group ( 2 and 3 participants , respectively , had improvement ; 36 and 37 had no change ; and 5 and 3 had worsening ; P = 0.41 ) .
-RESULTS	Total-ear hearing ( hearing in one or both ears that could be evaluated ) was more likely to be improved or to remain normal at 12 months in the 6-month group than in the 6-week group ( 73 % vs. 57 % , P = 0.01 ) .
-RESULTS	The benefit in total-ear hearing was maintained at 24 months ( 77 % vs. 64 % , P = 0.04 ) .
-RESULTS	At 24 months , the 6-month group , as compared with the 6-week group , had better neurodevelopmental scores on the Bayley Scales of Infant and Toddler Development , third edition , on the language-composite component ( P = 0.004 ) and on the receptive-communication scale ( P = 0.003 ) .
-RESULTS	Grade 3 or 4 neutropenia occurred in 19 % of the participants during the first 6 weeks .
-RESULTS	During the next 4.5 months of the study , grade 3 or 4 neutropenia occurred in 21 % of the participants in the 6-month group and in 27 % of those in the 6-week group ( P = 0.64 ) .
-CONCLUSIONS	Treating symptomatic congenital CMV disease with valganciclovir for 6 months , as compared with 6 weeks , did not improve hearing in the short term but appeared to improve hearing and developmental outcomes modestly in the longer term .
-CONCLUSIONS	( Funded by the National Institute of Allergy and Infectious Diseases ; ClinicalTrials.gov number , NCT00466817 . )
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-###24428097
-OBJECTIVE	To compare the incidence and severity of emergence agitation , recovery profile , and adverse events between desflurane and sevoflurane anesthesia in unpremedicated pediatric ambulatory urologic surgery patients .
-METHODS	The study was conducted among 136 healthy children , aged six months to nine years , and randomized to two groups , sevoflurane and desflurane , during maintenance anesthesia with laryngeal mask airway .
-METHODS	Recovery profile and perioperative adverse events were recorded .
-METHODS	The emergence agitation ( EA ) was assessed using a 4-point scale by an anesthetist nurse in the recovery room who was blinded to the treatment .
-RESULTS	The incidences of EA between sevoflurane/desflurane were not significantly different at 36.8 % / 41.2 % , p = 0.73 , and neither was the median ( IQR ) of severity ( 2 ( 1 , 3 ) / 2 ( 1 , 3 ) , p = 0.4 ) .
-RESULTS	The awakening time in the desflurane group was 6.4 + / - 4.0 minutes , faster than in the sevoflurane group of 10.6 + / - 7.6 minutes ( p < 0.001 ) .
-RESULTS	The number of children having intraoperative respiratory events was significantly higher in the desflurane group ( 17 ) , compared to the sevoflurane group ( 7 ) ( p = 0.043 ) .
-CONCLUSIONS	The occurrence of EA and adverse events between sevoflurane and desflurane were not different , except that the overall of intraoperative respiratory events was higher in desflurane group .
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-###24838844
-BACKGROUND	Previous research suggests that African American smokers may have improved outcomes if interventions are culturally specific .
-BACKGROUND	However , few interventions sufficiently address the unique needs of this population in a format with large reach potential .
-BACKGROUND	The purpose of this study was to test the efficacy of a newly developed digital video disc ( DVD ) - based cessation intervention targeting African Americans .
-METHODS	In a 2-arm randomized trial , smokers ( N = 140 ) were randomly assigned to view either the new Pathways to Freedom ( PTF ) DVD or a standard control DVD .
-METHODS	Participants were assessed at baseline , immediately postviewing the DVD , and at a 1-month follow-up .
-METHODS	The primary outcomes were feasibility and process variables , including intervention evaluations , readiness to quit , and risk perceptions , and smoking-related behavior changes were examined as secondary outcomes .
-RESULTS	Findings demonstrated the hypothesized positive effects of the PTF DVD compared with the control DVD on content evaluations , risk perceptions , and readiness to quit at follow-up .
-CONCLUSIONS	We found initial evidence for the efficacy of the PTF DVD as a stand-alone intervention .
-CONCLUSIONS	Future research will test the efficacy of the DVD for smoking cessation in a larger randomized trial .
-CONCLUSIONS	The ultimate goal of this research is to validate a new intervention for an underserved community of smokers that can be used in multiple settings , such as community health clinics , primary care , quitlines , cessation clinics , and seminars/workshops .
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-###24582162
-BACKGROUND	The aim of this multicenter study was to determine the normal ranges and the clinical relevance of multidirectional systolic parameters to evaluate global left ventricular ( LV ) systolic function .
-METHODS	Three hundred twenty-three healthy adult subjects prospectively included at 10 centers and a cohort of 310 patients with hypertension were analyzed .
-METHODS	Multidirectional global LV systolic function was analyzed using two-dimensional speckle-tracking echocardiography by means of two indices : longitudinal-circumferential systolic index ( the average of longitudinal and circumferential global systolic strain ) and global systolic index ( the average of longitudinal , circumferential , and radial global systolic strain ) .
-RESULTS	The ranges of values of the multidirectional systolic parameters in healthy subjects were -21.22 2.22 % for longitudinal-circumferential systolic index and 29.71 5.28 % for global systolic index .
-RESULTS	In addition , the lowest expected values of these multidirectional indices were determined in this population ( calculated as -1.96 SDs from the mean ) : -16.86 % for longitudinal-circumferential systolic index and 19.36 % for global systolic index .
-RESULTS	Concerning the clinical relevance of these measurements , these indices indicated the presence of subtle LV global systolic dysfunction in patients with hypertension , even though LV global longitudinal systolic strain and LV ejection fraction were normal .
-RESULTS	Moreover , in these patients , functional class ( dyspnea [ New York Heart Association classification ] ) was inversely related to both the longitudinal-circumferential index and the global systolic index .
-CONCLUSIONS	In the present multicenter study analyzing a large cohort of healthy subjects and patients with hypertension , the normal range and the clinical relevance of multidirectional systolic parameters to evaluate global LV systolic function have been determined .
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-###24402825
-METHODS	Curcumin revealed various health-beneficial properties in numerous studies .
-METHODS	However its bioavailability is low due to its limited intestinal uptake and rapid metabolism .
-METHODS	The aim of our project was to develop novel curcumin formulations with improved oral bioavailability and to study their safety as well as potential sex-differences .
-RESULTS	In this crossover study , healthy subjects ( 13 women , 10 men ) took , in random order , a single oral dose of 500 mg curcuminoids as native powder , micronized powder , or liquid micelles .
-RESULTS	Blood and urine samples were collected for 24 h and total curcuminoids and safety parameters were quantified .
-RESULTS	Based on the area under the plasma concentration-time curve ( AUC ) , the micronized curcumin was 14 - , 5 - , and 9-fold and micellar curcumin 277 - , 114 - , and 185-fold better bioavailable than native curcumin in women , men , and all subjects , respectively .
-RESULTS	Thus , women absorbed curcumin more efficiently than men .
-RESULTS	All safety parameters remained within the reference ranges following the consumption of all formulations .
-CONCLUSIONS	Both , the micronized powder and in particular the liquid micellar formulation of curcumin significantly improved its oral bioavailability without altering safety parameters and may thus be ideally suited to deliver curcumin in human intervention trials .
-CONCLUSIONS	The observed sex differences in curcumin absorption warrant further investigation .
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-###24583275
-OBJECTIVE	Late adolescence represents a developmental risk period when many youth become involved in multiple forms of high-risk behaviors with adverse consequences .
-OBJECTIVE	This study assessed the degree to which two such behaviors , adolescent sexual behaviors and gambling , were associated in a community-based sample with a large African-American presence .
-METHODS	Data are derived from a cohort study .
-METHODS	This study focuses on 427 African-American participants with complete information on gambling and sexual behaviors by age 18 ( 72 % of original cohort ) .
-METHODS	Gambling involvement and related problems were based on responses to the South Oaks Gambling Screen - Revised for Adolescents .
-METHODS	Several questions assessed sexual behaviors , including age of initiation .
-METHODS	Multivariable logistic regression models adjusted for demographics , intervention status , impulsivity , depressive and anxiety symptoms , and alcohol and illegal drug use .
-RESULTS	Almost half of the sample ( 49 % , n = 211 ) had gambled at least once before age 18 .
-RESULTS	More gamblers than non-gamblers had initiated sexual intercourse by age 18 ( aOR : 2.29 [ 1.16 , 4.52 ] ) .
-RESULTS	Among those who had initiated sexual activity , more gamblers than non-gamblers with high impulsivity levels at age 13 ( vs. low impulsivity levels ) had become pregnant or had impregnated someone .
-RESULTS	Among those who had initiated sexual activity by age 18 , more male gamblers had impregnated someone by age 18 as compared to female gamblers becoming pregnant .
-CONCLUSIONS	Gambling and sexual behaviors often co-occur among adolescents .
-CONCLUSIONS	Such findings prompt the need for the inclusion of gambling , an often overlooked risky behavior , in behavioral prevention/intervention programs targeting adolescents .
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-###24463657
-OBJECTIVE	Laparoscopic and robotic sacrocolpopexy are widely used for pelvic organ prolapse ( POP ) treatment .
-OBJECTIVE	Evidence comparing outcomes and costs is lacking .
-OBJECTIVE	We compared costs and clinically relevant outcomes in women randomized to laparoscopic sacrocolpopexy compared with robotic sacrocolpopexy .
-METHODS	Participants with symptomatic stage POP II or greater , including significant apical support loss , were randomized to either laparoscopic or robotic sacrocolpopexy .
-METHODS	We compared surgical costs ( including costs for robot , initial hospitalization ) and rehospitalization within 6 weeks .
-METHODS	Secondary outcomes included postoperative pain , POP quantification , symptom severity and quality of life , and adverse events .
-RESULTS	We randomized 78 women ( mean age 59 years ) : laparoscopic ( n = 38 ) and robotic ( n = 40 ) .
-RESULTS	The robotic sacrocolpopexy group had higher initial hospital costs ( $ 19,616 compared with $ 11,573 , P < .001 ) and over 6 weeks , hospital costs remained higher for robotic sacrocolpopexy ( $ 20,898 compared with $ 12,170 , P < .001 ) .
-RESULTS	When we excluded costs of robot purchase and maintenance , we did not detect a statistical difference in initial day of surgery costs of robotic compared with laparoscopic ( $ 12,586 compared with $ 11,573 ; P = .160 ) or hospital costs over 6 weeks ( $ 13,867 compared with $ 12,170 ; P = .060 ) .
-RESULTS	The robotic group had longer operating room times ( 202.8 minutes compared with 178.4 minutes , P = .030 ) and higher pain scores 1 week after surgery ( 3.52.1 compared with 2.62.2 ; P = .044 ) .
-RESULTS	There were no group differences in symptom bother by Pelvic Floor Distress Inventory , POP stage , or rate of adverse events .
-CONCLUSIONS	Costs of robotic sacrocolpopexy are higher than laparoscopic , whereas short-term outcomes and complications are similar .
-CONCLUSIONS	Primary cost differences resulted from robot maintenance and purchase costs .
-BACKGROUND	Clinicaltrials.gov , www.clinicaltrials.gov , NCT01124916 .
-METHODS	I.
-
-###25046547
-BACKGROUND	Proton pump inhibitor ( PPI ) increases the risk of decrease in bone mineral density ( BMD ) .
-BACKGROUND	However , whether calcitrol improves this situation is unknown .
-OBJECTIVE	The current study investigates the effects of calcitriol on BMD in patients with esomeprazole therapy .
-METHODS	Three hundred and eighty-six participants with gastrointestinal ulcerations were enrolled and randomly assigned into controlled and supplemented groups .
-METHODS	Participants in the controlled group were prescribed esomeprazole ( 20mg/qd ) , while the supplemented group was prescribed esomeprazole ( 20mg/qd ) and calcitriol ( 2.5 g/qd ) .
-METHODS	BMD , serum levels of calcium , carboxy-terminal collagen crosslinks ( CTX ) , and alkaline-phosphatase ( ALP ) were assessed .
-RESULTS	( 1 ) No significant between-group difference of age , gender , smoking , previous glucocorticoid use and hemoglobin level was found ; ( 2 ) after 10.60.8 d of PPI therapy , BMD T score in the controlled group was slightly increased compared with initial ( -1.250.08 versus -1.280.06 , p = 0.084 ) , while there was no change in the supplemented group ( -1.250.05 versus -1.260.03 , p = 0.308 ) ; ( 3 ) during study termination , calcium level in the supplemented group was slightly higher than the controlled group ( 2.050.03 mmol/L versus 2.010.05 mmol/L , p = 0.073 ) , while no significant differences of CTX ( 366.5743.71 pg/mL versus 373.1550.23 pg/mL , p = 0.036 ) and ALP were found among these two groups ( 50.479.32 U/L versus 52.2310.45 U/L , p = 0.075 ) .
-CONCLUSIONS	Patients with gastrointestinal ulcerations with esomeprazole therapy , calcitriol supplement showed no efficacy on BMD changes .
-
-###24814528
-BACKGROUND	Polycystic ovary syndrome ( PCOS ) is the most common endocrine cause of menstrual irregularities , hirsutism and acne .
-BACKGROUND	Women with PCOS present elevated plasma insulin levels , both fasting and after a glucose load , as an indirect evidence of insulin resistance .
-BACKGROUND	PCOS women may also present hypertension , low levels of HDL cholesterol , hypertriglyceridemia , visceral obesity and a higher level of CRP and fibrinogen that can predict an atherosclerotic risk .
-METHODS	This study was carried out on 15 young women with PCOS selected according to the 2003 diagnostic criteria of The Rotterdam Consensus Statement and 15 Control women .
-METHODS	PCOS women were treated with pioglitazone 30 mg/day and at the beginning and after 6 months of treatment were evaluated : menstrual cycle trend , hirsutism and acne , total cholesterolemia and HDL , triglyceridemia , fibrinogenemia , C-reactive protein , oral glucose tolerance test , glycated hemoglobin , FSH , LH , 17OH-progesterone , 17-estradiol , free and total testosterone , SHBG , DHEA-S , 4-androstenedione and adiponectin .
-CONCLUSIONS	Treatment with pioglitazone improves the irregularities of menses and hirsutism .
-CONCLUSIONS	Six months of treatment modify other parameters linked with a higher risk of type 2 diabetes mellitus and cardiovascular diseases : adiponectin increased with reduction of insulin resistance while fibrinogen and CRP levels decreased .
-
-###25864242
-OBJECTIVE	To determine the efficacy in reducing dentin hypersensitivity ( DHS ) of a combined in-office and home-use desensitizing system , each product containing 8 % arginine and calcium carbonate ( Test ) , following a dental scaling procedure , compared to the combination of a conventional prophylactic paste and a potassium nitrate dentifrice ( Control ) , in a group of patients with known dentin hypersensitivity .
-METHODS	An 8-week clinical study , with 50 subjects , was conducted in Piracicaba , So Paulo , Brazil , using a double-blind/two treatment design .
-METHODS	Air blast sensitivity assessments were used to compare the efficacy of the two approaches using both the Schiff scale as well as a Visual Analogue Scale ( VAS ) .
-RESULTS	Immediately after prophylaxis , the Test treatment provided significant reduction in DHS when compared to baseline values ( VAS = 26.2 % and Schiff = 29.1 % ) , while for Control treatment this difference was not statistically significant ( VAS = 8.1 % and Schiff = 6.6 % ) .
-RESULTS	The comparison between groups after prophylaxis showed a greater DHS reduction for the Test treatment ( P < 0.05 ) .
-RESULTS	The reductions in DHS after 2 , 4 and 8 weeks were significant for both groups , however , when considering Schiff scale , the Test treatment provided greater DHS reduction after 2 weeks ( 44.5 % for Test versus 27.7 % for Control ) and 4 weeks ( 55.2 % for Test and 40.5 % for Control ) , while after 8 weeks there was no significant difference between groups ( 71.1 % for Test versus 61.1 % for Control ) .
-
-###26390793
-OBJECTIVE	To compare vision quality following phacoemulsification cataract extraction and implantation of a Big Bag or Akreos Adapt intraocular lens ( IOL ) in patients diagnosed with high myopia complicated with cataract .
-METHODS	This was a randomized prospective control study .
-METHODS	The patients with high myopia .
-METHODS	complicated with cataract , with axial length 28 mm , and corneal astigmatism 1D were enrolled and randomly divided into the Big Bag and Akreos Adapt IOL groups .
-METHODS	All patients underwent phacoemulsification cataract extraction and lens implantation .
-METHODS	At 3 months after surgery , intraocular high-order aberration was measured by a Tracey-iTrace wavefront aberrometer at a pupil diameter of 5 mm in an absolutely dark room and statistically compared between two groups .
-METHODS	The images of the anterior segment of eyes were photographed with a Scheimpflug camera using Penta-cam three-dimensional anterior segment analyzer .
-METHODS	The tilt and decentration of the IOL were calculated by Image-pro plus 6.0 imaging analysis software and statistically compared between two groups .
-RESULTS	In total , 127 patients ( 127 eyes ) , including 52 males and 75 females , were enrolled in this study .
-RESULTS	The total high-order aberration and coma in the Akreos Adapt group ( 59 eyes ) were significantly higher compared with those in the Big Bag ( P < 0.05 ) .
-RESULTS	The clover and spherical aberration did not differ between the two groups ( P > 0.05 ) .
-RESULTS	The horizontal and vertical decentration were significantly smaller in the Big Bag lens group than in the Akreos Adapt group ( both P < 0.05 ) , whereas the tilt of IOL did not significantly differ between the two groups ( P > 0.05 ) .
-CONCLUSIONS	Both Big Bag and Akreos Adapt IOLs possess relatively good intraocular stability implanted in patients with high myopia .
-CONCLUSIONS	Compared with the Akreos Adapt IOL , the Big Bag IOL presents with smaller intraocular high-order aberration .
-CONCLUSIONS	Coma is the major difference between the two groups .
-
-###25157767
-BACKGROUND	We hypothesized that the combination of bevacizumab , carboplatin , and pemetrexed will be an effective first-line regimen in fit , elderly patients with nonsquamous non-small-cell lung cancer .
-METHODS	Treatment-nave , stage IIIB/IV nonsquamous non-small-cell lung cancer patients more than 70 years old with good performance status ( Eastern Cooperative Oncology Group performance status 0-1 ) and adequate organ function were eligible .
-METHODS	Carboplatin area under the curve 6 , pemetrexed 500 mg/m , and bevacizumab 15 mg/kg were administered on day 1 of each 21-day cycle ( up to six cycles ) followed by maintenance pemetrexed and bevacizumab .
-METHODS	The primary end point of 6-month progression-free survival rate of at least 70 % was assessed using a one-stage binomial design .
-METHODS	Quality of life ( QOL ) questionnaires were administered .
-METHODS	Polymorphisms in genes encoding relevant proteins ( drug targets , transport , and metabolism proteins ) were correlated with treatment outcome .
-RESULTS	Fifty-seven eligible patients were enrolled .
-RESULTS	Median age was 74.5 years .
-RESULTS	Median treatment cycles received was 6 .
-RESULTS	The most common grade 3 or higher non-hematologic adverse events were fatigue ( 26 % ) and hypertension ( 11 % ) ; 16 % had grade 4 neutropenia and 6.5 % had grade 4 thrombocytopenia .
-RESULTS	Three patients experienced grade 3/4 hemorrhagic events ( one pulmonary , two gastrointestinal ) .
-RESULTS	Primary end point of PFS6 was 60 % ( 95 % confidence interval [ CI ] : 45.9-73 % ) .
-RESULTS	Median PFS was 7.0 months ( 95 % CI : 5.9-10 .1 ) , median overall survival was 13.7 months ( 95 % CI : 9.4-16 .8 ) .
-RESULTS	Polymorphic KDR and VEGFA variants correlated with survival and toxicity , respectively .
-RESULTS	There was no significant change in overall QOL scores over time .
-CONCLUSIONS	This regimen is feasible and did not decrease the QOL in this study population .
-CONCLUSIONS	However , it did not meet the primary efficacy end point .
-
-###24848178
-OBJECTIVE	The aim of this study was to evaluate patient satisfaction and cost in spinal and general anesthesia for lumbar disc surgery .
-METHODS	The study was performed on 66 ASA class I-II patients with one level lumbar disc herniation ( LDH ) .
-METHODS	In this prospective study , patients were assigned randomly to either spinal anesthesia or general anesthesia groups .
-METHODS	Hemodynamic variables , intraoperative opioid requirements , postoperative pain scores and analgesic requirements and complications were recorded .
-METHODS	Patients were handed a questionnaire about the procedure they underwent to determine patient satisfaction .
-METHODS	The costs of preoperative and postoperative anesthesia procedures , medications , and hospitalization were calculated individually .
-RESULTS	Spinal anesthesia and general anesthesia were similar concerning hemodynamic stability , first urination time , first mobilization time , postoperative analgesic requirement , and pain .
-RESULTS	Patients in group S needed less additional dose of fentanyl intraoperatively than the patients in group G. Patient satisfaction was significantly higher in Group S when compared to Group G. Total cost was higher in Group G compared to Group S.
-CONCLUSIONS	We conclude that successful LDH surgery can be performed using either anesthesia type .
-CONCLUSIONS	As long as patients are selected carefully , spinal anesthesia is a safe , comfortable , and a more economical alternative .
-
-###24707676
-OBJECTIVE	This study aims to determine the difference between transcervical resection of septum ( TCRS ) and transcervical incision of septum ( TCIS ) in the improvement of reproductive prognosis .
-METHODS	Women with uterine septum in the Affiliated Hospital of Ningxia Medical University were retrospectively analyzed .
-METHODS	A statistical method was used according to operative time , postoperative menstruation , postoperative pregnancy rate , postoperative term delivery rate , and so on .
-RESULTS	Compared with TCRS , the TCIS method decreased operative time , blood loss , and consumption of uterus distension medium .
-RESULTS	No statistical difference was observed in operative complications between the two methods .
-RESULTS	After TCIS , the incidence of uterine adhesion was low and the degree of endometrial epithelialisation was high by hysteroscopy review .
-RESULTS	No statistical difference was observed in residual septum after the operation .
-RESULTS	The total pregnancy rate after TCIS was higher than that of TCRS .
-RESULTS	However , no statistical difference was observed in early and late pregnancy loss rates , preterm birth rate , and term birth rate .
-CONCLUSIONS	TCIS exhibits advantages of decreasing operative time , blood loss , and consumption of uterus distension medium .
-CONCLUSIONS	TCIS can reduce the incidence of uterine adhesion and can promote endometrial epithelialisation , which are the key factors to increase pregnancy rate after operation .
-
-###25017001
-OBJECTIVE	Major depressive disorder has been linked with inflammatory processes , but it is unclear whether individual differences in levels of inflammatory biomarkers could help match patients to treatments that are most likely to be beneficial .
-OBJECTIVE	The authors tested the hypothesis that C-reactive protein ( CRP ) , a commonly available marker of systemic inflammation , predicts differential response to escitalopram ( a serotonin reuptake inhibitor ) and nortriptyline ( a norepinephrine reuptake inhibitor ) .
-METHODS	The hypothesis was tested in the Genome-Based Therapeutic Drugs for Depression ( GENDEP ) study , a multicenter open-label randomized clinical trial .
-METHODS	CRP was measured with a high-sensitivity method in serum samples from 241 adult men and women with major depressive disorder randomly allocated to 12-week treatment with escitalopram ( N = 115 ) or nortriptyline ( N = 126 ) .
-METHODS	The primary outcome measure was the score on the Montgomery-sberg Depression Rating Scale ( MADRS ) , administered weekly .
-RESULTS	CRP level at baseline differentially predicted treatment outcome with the two antidepressants ( CRP-drug interaction : = 3.27 , 95 % CI = 1.65 , 4.89 ) .
-RESULTS	For patients with low levels of CRP ( < 1 mg/L ) , improvement on the MADRS score was 3 points higher with escitalopram than with nortriptyline .
-RESULTS	For patients with higher CRP levels , improvement on the MADRS score was 3 points higher with nortriptyline than with escitalopram .
-RESULTS	CRP and its interaction with medication explained more than 10 % of individual-level variance in treatment outcome .
-CONCLUSIONS	An easily accessible peripheral blood biomarker may contribute to improvement in outcomes of major depressive disorder by personalizing treatment choice .
-
-###25636135
-OBJECTIVE	Chronic tension-type headache ( CTTH ) is a chronic syndrome characterized by frequent headache occurring more than 15 days per month .
-OBJECTIVE	The intensity and duration of headache pain can be very distressing and disabling on an individuals ' well-being .
-OBJECTIVE	The purpose of this study was to examine the applicability of sauna bathing as a new method of treatment for reducing pain in patients with CTTH .
-METHODS	Thirty-seven people who fulfilled the International Headache Society criteria for CTTH were randomly assigned into two groups .
-METHODS	The control group ( n = 20 ) received advice and education while the intervention group ( n = 17 ) received the same advice and attended a sauna regularly for 8 weeks .
-METHODS	Reductions in subjective pain were determined using the numerical pain rating scale ( NPRS ) .
-METHODS	Disturbance in sleep , depression as assessed by Beckman Disability Index ( BDI ) , and Headache Disability Index ( HDI ) were measured .
-RESULTS	Mean change in headache intensity significantly differed between the sauna and control group by 1.27 ( 95 % confidence interval , 0.48-2 .07 ; F = 10.17 ; df = 1 , 117 ; p = 0.002 ) .
-RESULTS	There was no statistically significant change in duration of headache or improvement in sleep , depression , or HDI between the sauna and control groups .
-CONCLUSIONS	Regular sauna bathing is a simple , self-directed treatment that is effective for reducing headache pain intensity in CTTH .
-
-###25103781
-BACKGROUND	Alpha adrenergic drugs are usually used in the treatment of erectile and ejaculatory dysfunction in humans .
-BACKGROUND	The influence of such drugs on the seminal characteristics of wild animals has not been verified ; whereas their impact on the seminal characteristics and erectile and ejaculatory functions of collared peccaries ( Tayassu tajacu ) has already been determined .
-BACKGROUND	This study aimed at investigating and comparing the effects of medetomidine and atipamezole on the seminal variables of collared peccaries undergoing electroejaculation as well as at determining whether these drugs affected the erectile and ejaculatory functions of this species .
-RESULTS	A statistically significant difference in sperm concentration was observed between AP ( 100.0 26.0 106 sperm/ml ) and MP ( 220.2 49.8 106 sperm/ml ) ; however , both these treatments did not differ from P treatment ( 180.0 50.7 106 sperm/ml ) .
-RESULTS	No statistically significant difference was observed among all treatments with regard to erectile function .
-RESULTS	With regard to ejaculation time , no significant difference was observed between the MP and AP treatments ; however , when compared with the P treatment , AP exhibited a significantly higher difference .
-CONCLUSIONS	When collared peccaries were anesthetized with propofol , neither medetomidine nor atipamezole significantly affected the characteristics of the semen or the erectile function , despite the fact that the AP treatment increased ejaculation time .
-CONCLUSIONS	Therefore , the data indicate that using propofol alone is an effective anesthetic protocol for collecting semen in collared peccaries .
-CONCLUSIONS	Other non-injectable anesthetic drugs , such as inhaled anesthetics , may be used in future research to collect semen from peccaries .
-
-###24256139
-BACKGROUND	The currently proven time window for thrombolysis in ischemic stroke is 4.5 h. Beyond this , the risks and benefits of thrombolysis are uncertain .
-OBJECTIVE	To determine whether thrombolysis and reperfusion were beneficial after 4.5 h , we examined clinical and radiological outcomes in patients treated with tissue plasminogen activator or placebo within 4.5-6h , using data from the Echoplanar Imaging Thrombolytic Evaluation Trial .
-METHODS	In the Echoplanar Imaging Thrombolytic Evaluation Trial , ischemic stroke patients presenting three to six-hours after stroke onset were randomized to tissue plasminogen activator or placebo , without knowledge of magnetic resonance imaging results .
-METHODS	This analysis was restricted to patients treated between 4.5 and 6h .
-METHODS	The effect of tissue plasminogen activator and reperfusion on infarct growth between baseline diffusion-weighted imaging and day 90 T2 imaging was assessed , along with good neurological outcome ( 8 point reduction or reaching 0-1 at 90 days on National Institutes of Health Stroke Scale ) and functional outcome ( modified Rankin scale ) .
-METHODS	The effect of tissue plasminogen activator on reperfusion was also analyzed .
-RESULTS	Sixty-nine patients were treated 4.5-6h after onset , and infarct growth was assessed in 63 .
-RESULTS	Tissue plasminogen activator was associated with lower relative growth ( 94 % vs. 168 % , P = 0.03 ) and a trend to lower absolute growth ( -0.17 ml versus 9.6 ml , P = 0.07 ) .
-RESULTS	Reperfusion was increased in the tissue plasminogen activator group ( 58 % versus 25 % , P = 0.03 ) and was associated with increased rates of good neurological ( 86 % versus 28 % P < 0.001 ) and functional ( modified Rankin scale 0-2 73 % versus 34 % , P = 0.01 ) outcomes .
-RESULTS	Reperfusion was strongly associated with lower relative ( 80 % versus 189 % , P < 0.001 ) and absolute ( -2.5 ml versus 40ml , P < 0.001 ) infarct growth .
-CONCLUSIONS	Thrombolysis 4.5-6h after stroke onset reduced infarct growth and increased the rate of reperfusion , which was associated with good neurological and functional outcome .
-
-###25109511
-BACKGROUND	Tianeptine is widely used for controlling depressive symptoms .
-OBJECTIVE	The aim of this study was to evaluate the bioequivalence between the generic ( test ) formulation containing tianeptine sodium 12.5 mg and the branded ( reference ) formulation Stablon with regard to their pharmacokinetic profiles .
-METHODS	A randomized , two-sequence , two-treatment crossover study was conducted in healthy male Korean volunteers .
-METHODS	All of the enrolled subjects were allocated to one of two sequence groups .
-METHODS	They were administered a tablet of the test or reference formulation and then administered the alternative formulation after a 7-day washout period .
-METHODS	The blood samples were taken before dosing and at 0.33 , 0.67 , 1 , 1.5 , 2 , 2.5 , 3 , 3.5 , 4 , 6 , 8 , and 10 hours after dosing .
-METHODS	The plasma concentrations of tianeptine were analyzed using high-performance liquid chromatography with tandem mass spectrometer .
-METHODS	Tolerability was assessed throughout the study .
-RESULTS	The pharmacokinetic parameters were assessed in the 40 subjects who completed the study .
-RESULTS	The tianeptine C ( max ) for the test formulation was 283.13 57.58 ng/mL ( mean SD ) and that for the reference formulation was 272.50 59.00 ng/mL .
-RESULTS	The AUC ( last ) of tianeptine was 803.24 180.94 ngh/mL for the test formulation and 792.27 180.93 ngh/mL for the reference formulation .
-RESULTS	The geometric mean ratio ( % ) of the test to reference formulation was 104.04 ( 90 % CI , 99.66 - 108.61 ) for C ( max ) and 101.30 ( 98.01 - 104.71 ) for AUC ( last ) .
-RESULTS	Clinically significant adverse events were not reported during the study .
-CONCLUSIONS	The test and reference formulations of tianeptine were bioequivalent with regard to the pharmacokinetic parameters of Cmax and AUC ( last ) .
-CONCLUSIONS	Both formulations were tolerated by all of the participants .
-
-###24581050
-BACKGROUND	Tinnitus is a result of hyper-activity/hyper-synchrony of auditory neurons coding the tinnitus frequency , which has developed to synchronous mass activity owing the lack of inhibition .
-BACKGROUND	We assume that removal of exactly these frequency components from an auditory stimulus will cause the brain to reorganize around tonotopic regions coding the tinnitus frequency .
-BACKGROUND	Based on this assumption a novel treatment for tonal tinnitus - tailor-made notched music training ( TMNMT ) ( Proc Natl Acad Sci USA 107:1207 -1210 , 2010 ; Ann N Y Acad Sci 1252:253 -258 , 2012 ; Frontiers Syst Neurosci 6:50 , 2012 ) has been introduced and will be tested in this clinical trial on a large number of tinnitus patients .
-METHODS	A randomized controlled trial ( RCT ) in parallel group design will be performed in a double-blinded manner .
-METHODS	The choice of the intervention we are going to apply is based on two `` proof of concept '' studies in humans ( Proc Natl Acad Sci USA 107:1207 -1210 , 2010 ; Ann N Y Acad Sci 1252:253 -258 , 2012 ; Frontiers Syst Neurosci 6:50 , 2012 ; PloS One 6 ( 9 ) : e24685 , 2011 ) and on a recent animal study ( Front Syst Neurosci 7:21 , 2013 ) .
-METHODS	The RCT includes 100 participants with chronic , tonal tinnitus who listened to tailor-made notched music ( TMNM ) for two hours a day for three months .
-METHODS	The effect of TMNMT is assessed by the tinnitus handicap questionnaire and visual analogue scales ( VAS ) measuring perceived tinnitus loudness , distress and handicap .
-CONCLUSIONS	This is the first randomized controlled trial applying TMNMT on a larger number of patients with tonal tinnitus .
-CONCLUSIONS	Our data will verify more securely and reliably the effectiveness of this kind of completely non-invasive and low-cost treatment approach on tonal tinnitus .
-BACKGROUND	Current Controlled Trials ISRCTN04840953 .
-
-###24754529
-BACKGROUND	Actinic damage is responsible for the development of multiple , recurrent non-melanoma skin cancers ( NMSCs ) , including actinic keratoses ( AKs ) .
-BACKGROUND	Photodynamic therapy ( PDT ) and imiquimod cream ( IMIQ ) 5 % are recommended as field-directed treatment options .
-OBJECTIVE	To compare efficacy and safety of methyl aminolevulinate ( MAL ) - PDT vs. IMIQ 5 % in the prevention of new NMSCs development patients with field changes .
-METHODS	Patients with field cancerization of the face or scalp were randomized to receive MAL-PDT on one side , and IMIQ 5 % on the mirror field .
-METHODS	The primary endpoint was the number of new lesions on the treated fields during a 12-month follow-up period .
-METHODS	Secondary assessments included adverse events and patient preference .
-RESULTS	Forty-four patients completed the study .
-RESULTS	MAL-PDT and IMIQ did not differ concerning the primary endpoint , as there was no statistically significant difference in terms of development of new NMSCs at any point of follow-up .
-RESULTS	Both treatment regimens were safe and well tolerated .
-RESULTS	Patients ' preference based on the procedure , response rates and future choice favoured MAL-PDT .
-CONCLUSIONS	MAL-PDT and IMIQ 5 % are safe and well-tolerated treatments that equally prevent development of new AKs in patients suffering from field changes .
-CONCLUSIONS	MAL-PDT treatment appears to be superior in terms of patients ' preference .
-
-###24980392
-BACKGROUND	DX-2930 is a human monoclonal antibody inhibitor of plasma kallikrein under investigation for long-term prophylaxis of hereditary angioedema .
-OBJECTIVE	To assess the safety , tolerability , pharmacokinetics , and pharmacodynamics of DX-2930 in healthy subjects .
-METHODS	A single-center , double-blinded study was performed in 32 healthy subjects randomized 3:1 to receive a single subcutaneous administration of DX-2930 or placebo within 1 of 4 sequential , ascending dose cohorts ( n = 8 each ) : 0.1 , 0.3 , 1.0 , or 3.0 mg/kg .
-RESULTS	No dose-limiting toxicity was observed .
-RESULTS	Headache was the most commonly reported treatment emergent adverse event ( AE ) , occurring at a rate of 25 % in the DX-2930 - and placebo-treated groups ; none were severe and all resolved .
-RESULTS	There were no serious AEs , discontinuations owing to an AE , or deaths .
-RESULTS	Two subjects had a severe AE reported as related to treatment by the blinded investigator ; the 2 AEs were asymptomatic creatinine phosphokinase elevations of 902 U/L in 1 subject receiving 0.1 mg/kg DX-2930 and 1,967 U/L in 1 subject receiving placebo .
-RESULTS	For the 0.1 - , 0.3 - , 1.0 - , and 3.0-mg / kg dose groups , respectively , mean maximum plasma concentrations were 0.6 , 1.4 , 5.6 , and 14.5 g/mL and mean elimination half-lives were 20.6 , 16.8 , 17.6 , and 21.2 days .
-RESULTS	Exploratory biomarker assays , involving exvivo activation of the kallikrein pathway , showed dose - and time-dependent inhibition of plasma kallikrein , with evidence of sustained bioactivity consistent with the pharmacokinetics profile .
-CONCLUSIONS	A single administration of DX-2930 in healthy subjects up to doses of 3.0 mg/kg was well tolerated without dose-limiting toxicity .
-CONCLUSIONS	Pharmacokinetic and pharmacodynamic data provide evidence fora long-acting biological effect relevant to long-term prophylaxis for hereditary angioedema with C1-inhibitor deficiency .
-BACKGROUND	ClinicalTrials.gov identifier : NCT01923207 .
-
-###24375969
-OBJECTIVE	The impact of a text messaging-assisted lifestyle weight loss intervention on weight change among overweight adults in Beijing was examined .
-METHODS	It was a 6-month randomized two arm clinical trial .
-METHODS	The control group received a brief advice session after randomization .
-METHODS	The intervention group received three group sessions , five coaching calls , and a daily text message prompting participants to follow predetermined lifestyle goals .
-RESULTS	A total of 123 participants were randomized .
-RESULTS	At 6 months , controls gained 0.24 0.28 kg ( 0.21 % 0.38 % ) ( NS ) while intervention participants lost 1.6 0.28 kg ( 2.31 % 0.38 % ) ( p < 0.0001 ) .
-RESULTS	Intervention participants decreased waist circumference ( WC ) ( -2.69 0.43 cm , p < 0.0001 ) , percent body fat ( % BF ) ( -0.66 % 0.19 % , p = 0.0007 ) , and systolic/diastolic blood pressure ( SBP/DBP ) significantly ( -1.71 1.12 / -3.24 0.87 mmHg ) , while the controls had no change in WC and % BF and increased SBP/DBP by 2.43 1.14 / 1.20 0.88 mmHg ( between groups : p = 0.01 / p = 0.0004 ) .
-CONCLUSIONS	This text message-assisted lifestyle intervention was effective in reducing weight , WC , % BF , and improving BP .
-CONCLUSIONS	Coupled with the scalable feature of the intervention , this finding is intriguing in light of the potential reach of the intervention for countries like China where mobile phone penetration is high and the obesity rate continues to rise .
-
-###25962601
-OBJECTIVE	Rheumatoid arthritis ( RA ) is a chronic autoimmune disease where TNF - is a central mediator of inflammation , and is cleaved from the cell surface by TACE/ADAM17 .
-OBJECTIVE	This metalloproteinase is also responsible for the release of soluble ( s ) CD163 .
-OBJECTIVE	Soluble CD163 reflects macrophage activation .
-OBJECTIVE	In RA , sCD163 has been suggested as a marker of disease activity and progression .
-OBJECTIVE	Our aim is to investigate sCD163 levels in early RA patients .
-METHODS	Soluble CD163 was measured by ELISA from 150 RA plasma samples from the OPERA trial .
-METHODS	Averaged disease duration was three months , prior to randomisation with methotrexate ( MTX ) and adalimumab ( DMARD+ADA ) or MTX and placebo ( DMARD+PLA ) .
-METHODS	Soluble CD163 levels were evaluated in relation to clinical disease parameters .
-RESULTS	Plasma sCD163 at baseline was 2.39 mg/l ( 1.74 mg/l -3.18 mg/l ) , mean ( 95 % CI ) , vs healthy controls : 1.63 mg/l ( 1.54 mg/l - 1.73 mg/l ) , ( p < 0.001 ) .
-RESULTS	After three months of treatment sCD163 levels decreased significantly ( average 23.5 % ) in both treatment groups .
-RESULTS	Significant incremental sCD163 levels followed withdrawal of ADA after 12 months of treatment .
-RESULTS	Baseline sCD163 correlated with CRP and all investigated disease activity markers ( = 0.16-0 .28 , p < 0.05 ) .
-RESULTS	In the DMARD+PLA group baseline sCD163 also correlated with CRP during the follow-up period .
-CONCLUSIONS	Soluble CD163 correlated with disease activity markers in early RA before treatment .
-CONCLUSIONS	Plasma sCD163 may add to currently available disease measures by specifically reflecting changes in macrophage activity as evidenced by increasing levels following anti-TNF withdrawal , despite maintenance of a stable clinical condition achieved by conventional remedies .
-CONCLUSIONS	It remains to be determined whether sCD163 is an early predictor of disease flare .
-
-###26027881
-BACKGROUND	Whether patients with early-stage oral cancers should be treated with elective neck dissection at the time of the primary surgery or with therapeutic neck dissection after nodal relapse has been a matter of debate .
-METHODS	In this prospective , randomized , controlled trial , we evaluated the effect on survival of elective node dissection ( ipsilateral neck dissection at the time of the primary surgery ) versus therapeutic node dissection ( watchful waiting followed by neck dissection for nodal relapse ) in patients with lateralized stage T1 or T2 oral squamous-cell carcinomas .
-METHODS	Primary and secondary end points were overall survival and disease-free survival , respectively .
-RESULTS	Between 2004 and 2014 , a total of 596 patients were enrolled .
-RESULTS	As prespecified by the data and safety monitoring committee , this report summarizes results for the first 500 patients ( 245 in the elective-surgery group and 255 in the therapeutic-surgery group ) , with a median follow-up of 39 months .
-RESULTS	There were 81 recurrences and 50 deaths in the elective-surgery group and 146 recurrences and 79 deaths in the therapeutic-surgery group .
-RESULTS	At 3 years , elective node dissection resulted in an improved rate of overall survival ( 80.0 % ; 95 % confidence interval [ CI ] , 74.1 to 85.8 ) , as compared with therapeutic dissection ( 67.5 % ; 95 % CI , 61.0 to 73.9 ) , for a hazard ratio for death of 0.64 in the elective-surgery group ( 95 % CI , 0.45 to 0.92 ; P = 0.01 by the log-rank test ) .
-RESULTS	At that time , patients in the elective-surgery group also had a higher rate of disease-free survival than those in the therapeutic-surgery group ( 69.5 % vs. 45.9 % , P < 0.001 ) .
-RESULTS	Elective node dissection was superior in most subgroups without significant interactions .
-RESULTS	Rates of adverse events were 6.6 % and 3.6 % in the elective-surgery group and the therapeutic-surgery group , respectively .
-CONCLUSIONS	Among patients with early-stage oral squamous-cell cancer , elective neck dissection resulted in higher rates of overall and disease-free survival than did therapeutic neck dissection .
-CONCLUSIONS	( Funded by the Tata Memorial Centre ; ClinicalTrials.gov number , NCT00193765 . )
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-###24722045
-OBJECTIVE	The goal of this study was to preliminarily test the efficacy of a telephone intervention , Family Intervention : Telephone Tracking , designed to assist stroke survivors and their primary caregivers during the first 6 months after stroke .
-METHODS	Forty-nine stroke survivors and their caregivers were randomly assigned to treatment as usual or treatment as usual plus the telephone intervention .
-METHODS	Global outcomes are reported for health care utilization , family functioning , and general functioning .
-RESULTS	Family and general functioning were positively and significantly changed at 3 and 6 months .
-RESULTS	Health care utilization was positively and significantly changed at 3 months .
-CONCLUSIONS	Findings suggest that the model has the potential to decrease health care utilization and improve quality of life for stroke survivors and their caregivers .
-CONCLUSIONS	Further study is warranted .
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-###24449733
-OBJECTIVE	Transesophageal echocardiography has become a standard tool for evaluating left ventricular function during cardiac surgery .
-OBJECTIVE	However , the image quality varies widely between patients and examinations .
-OBJECTIVE	The aim of this study was to investigate the influence of the image quality on 5 commonly used 2-dimensional methods .
-METHODS	Transesophageal real-time 3-dimensional echocardiography ( 3DE ) served as a reference .
-METHODS	Left ventricular function was evaluated in 63 patients with sufficient real-time 3DE image quality .
-METHODS	The image quality was rated using the ratio of the visualized border divided by the total endocardial border .
-METHODS	These ratings were used to generate groups of poor ( 0 % -40 % ) , fair ( 41 % -70 % ) , and good ( 71 % -100 % ) image quality .
-METHODS	The ejection fraction ( EF ) , end-diastolic volume , and end-systolic volume were analyzed by the Simpson method of disks ( biplane and monoplane ) , eyeball method , Teichholz method , and speckle-tracking method .
-METHODS	Furthermore , the fractional area change was determined .
-METHODS	Each correlation with real-time 3DE was evaluated .
-RESULTS	Correlations of the EF and volumes , respectively , as determined by long-axis view methods increased with improving image quality : the Simpson biplane method was found to be the most accurate method , with good image quality for the EF ( r = 0.946 ) and volumes ( end-diastolic volume , r = 0.962 ; end-systolic volume , r = 0.989 ) .
-RESULTS	Correlations of the EF and fractional area change by short-axis view methods decreased with improving image quality , with the Teichholz EF found to be most accurate with poor ( r = 0.928 ) in contrast to good ( r = 0.699 ) image quality .
-CONCLUSIONS	With good image quality , the Simpson biplane method is the most accurate 2-dimensional method for assessing the left ventricular EF .
-CONCLUSIONS	Short-axis view methods , especially the Teichholz method yield better correlations with poor image quality .
-CONCLUSIONS	The eyeball method was unaffected by image quality .
-
-###25228130
-BACKGROUND	In this study , we aimed to evaluate the protective effect of tight glucose control during cardiopulmonary bypass on myocardium in adult nondiabetic patients undergoing isolated aortic valve replacement in a prospective and randomized trial .
-METHODS	Sixty-five adult nondiabetic patients undergoing selective isolated aortic valve replacement were enrolled and randomly assigned to an insulin group ( patients received a continuous insulin infusion during surgery ; n = 33 ) or a control group ( patients were not administered insulin unless their blood glucose level exceeded 200 mg/dL ; n = 32 ) .
-METHODS	Cardiac troponin I was assayed preoperatively , and then at 2 , 6 , 12 , 24 , and 48 hours after aortic cross-declamping .
-METHODS	The pre - , intra - , and postoperative relevant data of all selected patients were analyzed .
-RESULTS	Tight glucose control reduced postoperative peak release by 48 % for cardiac troponin I compared with the control group ( 0.48 0.12 vs 0.71 0.17 ng/mL ; P < 0.0001 ) .
-RESULTS	Patients with continuous insulin infusion had lower peak inotropic score during the first postoperative 24 hours and peak level of blood glucose ( 5.8 2.2 vs 8.2 3.1 g/kg/min ; P < 0.0001 ; 131.9 23.8 vs 191.1 38.5 mg/dL ; P < 0.001 , respectively ) , shorter duration of mechanical ventilation and intensive care unit stay and hospital stay compared with the control group ( 11.6 2.9 hours vs 14.8 3.5 hours ; P = 0.0002 ; 28.4 7.2 hours vs 36.5 7.8 hours ; P < 0.0001 ; 9.4 3.3 days vs 11.5 4.2 days ; P = 0.0283 , respectively ) .
-CONCLUSIONS	Tight glucose control during cardiopulmonary bypass might provide myocardial protection in adult nondiabetic patients undergoing isolated aortic valve replacement .
-
-###24726507
-OBJECTIVE	The decision of whether to retain or remove a previously placed cervical cerclage in women who subsequently rupture fetal membranes in a premature gestation is controversial and all studies to date are retrospective .
-OBJECTIVE	We performed a multicenter randomized controlled trial of removal vs retention of cerclage in these patients to determine whether leaving the cerclage in place prolonged gestation and/or increased the risk of maternal or fetal infection .
-METHODS	A prospective randomized multicenter trial of 27 hospitals was performed .
-METHODS	Patients included were those with cerclage placement at 23 weeks 6 days in singleton or twin pregnancies , with subsequent spontaneous rupture of membranes between 22 weeks 0 days and 32 weeks 6 days .
-METHODS	Patients were randomized to retention or removal of cerclage .
-METHODS	Patients were then expectantly managed and delivered only for evidence of labor , chorioamnionitis , fetal distress , or other medical or obstetrical indications .
-METHODS	Management after 34 weeks was at the clinician 's discretion .
-RESULTS	The initial sample size calculation determined that a total of 142 patients should be included but after a second interim analysis , futility calculations determined that the conditional power for showing statistical significance after randomizing 142 patients for the primary outcome of prolonging pregnancy was 22.8 % .
-RESULTS	Thus the study was terminated after a total of 56 subjects were randomized with complete data available for analysis , 32 to removal and 24 to retention of cerclage .
-RESULTS	There was no statistical significance in primary outcome of prolonging pregnancy by 1 week comparing the 2 groups ( removal 18/32 , 56.3 % ; retention 11/24 , 45.8 % ) P = .59 ; or chorioamnionitis ( removal 8/32 , 25.0 % ; retention 10/24 , 41.7 % ) P = .25 , respectively .
-RESULTS	There was no statistical difference in composite neonatal outcomes ( removal 16/33 , 50 % ; retention 17/30 , 56 % ) , fetal/neonatal death ( removal 4/33 , 12 % ; retention 5/30 , 16 % ) ; or gestational age at delivery ( removal mean 200 days ; retention mean 198 days ) .
-CONCLUSIONS	Statistically significant differences were not seen in prolongation of latency , infection , or composite neonatal outcomes .
-CONCLUSIONS	However , there was a numerical trend in the direction of less infectious morbidity , with immediate removal of cerclage .
-CONCLUSIONS	These findings may not have met statistical significance if the original sample size of 142 was obtained , however they provide valuable data suggesting that there may be no advantage to retaining a cerclage after preterm premature rupture of membranes and a possibility of increased infection with cerclage retention .
-
-###24871247
-OBJECTIVE	To compare the speed and accuracy of answering clinical questions using Google versus summary resources .
-METHODS	In 2011 and 2012 , 48 internal medicine interns from two classes at Rutgers University Robert Wood Johnson Medical School , who had been trained to use three evidence-based summary resources , performed four-minute computer searches to answer 10 clinical questions .
-METHODS	Half were randomized to initiate searches for answers to questions 1 to 5 using Google ; the other half initiated searches using a summary resource .
-METHODS	They then crossed over and used the other resource for questions 6 to 10 .
-METHODS	They documented the time spent searching and the resource where the answer was found .
-METHODS	Time to correct response and percentage of correct responses were compared between groups using t test and general estimating equations .
-RESULTS	Of 480 questions administered , interns found answers for 393 ( 82 % ) .
-RESULTS	Interns initiating searches in Google used a wider variety of resources than those starting with summary resources .
-RESULTS	No significant difference was found in mean time to correct response ( 138.5 seconds for Google versus 136.1 seconds for summary resource ; P = .72 ) .
-RESULTS	Mean correct response rate was 58.4 % for Google versus 61.5 % for summary resource ( mean difference -3.1 % ; 95 % CI -10.3 % to 4.2 % ; P = .40 ) .
-CONCLUSIONS	The authors found no significant differences in speed or accuracy between searches initiated using Google versus summary resources .
-CONCLUSIONS	Although summary resources are considered to provide the highest quality of evidence , improvements to allow for better speed and accuracy are needed .
-
-###24510077
-OBJECTIVE	To assess LASIK flaps made by femtosecond laser and mechanical microkeratome .
-METHODS	Clinical , prospective , randomized , masked study of 32 eyes ( 16 patients ) .
-METHODS	Both eyes of all patients were operated , each patient underwent different techniques for lasik .
-METHODS	Microkeratome Hansatome ( TM ) Bausch & Lomb ( group microkeratome ) was used in one eye and femtosecond laser Femto LDV ( TM ) Ziemer ( group femtosecond ) was used for the fellow eye .
-METHODS	Patients were selected from the Refractive Surgery service of the Eye Hospital of Paran between July 2010 and September 2010 .
-METHODS	Inclusion criteria were myopia less than 6.00 D , astigmatism less than 3.00 D , hyperopia less than 5.00 D , stable refraction over one year , corneal diameter smaller than 11 mm , discontinuation of contact lenses seven days before the preoperative evaluation , corrected visual acuity of at least 20/20 .
-METHODS	Eyes were randomly allocated for each technique .
-METHODS	The studied variables were : visual acuity with and without correction , residual refractive error , high order aberrations , low contrast visual acuity , complications and subjective patient preference .
-RESULTS	All studied variables were similar between the two groups .
-CONCLUSIONS	We could not demonstrate any difference between the studied groups .
-
-###24472058
-BACKGROUND	Many physicians believe that the most effective way to treat chronic urticaria is to take a nonsedating second-generation H1 - antihistamine in the morning and a sedating first-generation H1 - antihistamine , usually hydroxyzine , at night to enhance sleep .
-BACKGROUND	But is this belief well founded ?
-OBJECTIVE	To test this belief by comparing the effectiveness and prevalence of unwanted sedative effects when treating patients with chronic spontaneous urticaria ( CSU ) with levocetirizine 15 mg daily plus hydroxyzine 50 mg at night ( levocetirizine plus hydroxyzine ) vs. levocetirizine 20 mg daily ( levocetirizine monotherapy ) .
-METHODS	In this randomized , double-blind , cross-over study , 24 patients with difficult-to-treat CSU took levocetirizine plus hydroxyzine or levocetirizine monotherapy for periods of 5 days each .
-METHODS	At the end of each treatment period , assessments were made of quality of life ( Chronic Urticaria Quality of Life Questionnaire , CU-Q2 oL ) , severity of urticaria symptoms ( Urticaria Activity Score , UAS ) , sleep disturbance during the night and daytime somnolence .
-RESULTS	Both treatments significantly decreased UAS , night-time sleep disturbances and CU-Q2 oL scores ( P < 0001 ) without significant differences between the two .
-RESULTS	Compared with baseline , daytime somnolence was significantly reduced by levocetirizine monotherapy ( P = 0006 ) but not by levocetirizine plus hydroxyzine ( P = 0218 ) .
-RESULTS	Direct comparison of the two treatment modalities in terms of daytime somnolence favoured levocetirizine monotherapy ( P = 0026 ) .
-CONCLUSIONS	The widespread belief that sleep is aided by the addition of a sedating first-generation H1 - antihistamine , usually hydroxyzine , at night is not supported .
-CONCLUSIONS	These results are in line with the urticaria guidelines , which state that first-line treatment for urticaria should be new-generation , nonsedating H1 - antihistamines only .
-
-###25440437
-BACKGROUND	Lignin peroxidase is a cosmetic skin-lightening alternative that breaks down plant cell walls and melanin .
-OBJECTIVE	This research examined the topical efficacy of lignin peroxidase in pigment lightening .
-METHODS	Sixty women aged 18 to 65 years with mild to moderate facial dyspigmentation were enrolled for 12 weeks in 2 cohorts .
-METHODS	Cohort 1 applied lignin peroxidase to 1 randomized side of the face and nothing to the opposite side .
-METHODS	Cohort 2 applied lignin peroxidase to 1 facial side and generic hydroquinone to the other .
-METHODS	Investigator , subject , and dermospectrophotometer measurements were obtained .
-RESULTS	In cohort 1 , improved skin texture ( P < .001 ) , roughness ( P < .001 ) , and overall appearance ( P = .002 ) was noted at week 2 with lignin peroxidase versus no treatment .
-RESULTS	By week 12 , there was a decrease in spot size with lignin peroxidase versus no treatment ( P = .014 ) .
-RESULTS	This was confirmed by a statistically significant reduction in melanin scores with the dermospectrophotometer on lignin peroxidase-treated side at weeks 4 , 8 , and 12 ( P = .003 ) and a similar reduction in Melasma Area Severity Index score .
-RESULTS	Cohort 2 demonstrated parity between lignin peroxidase and hydroquinone , but lignin peroxidase was statistically superior in skin texture and roughness .
-CONCLUSIONS	The sample size was limited .
-CONCLUSIONS	Lignin peroxidase might be an over-the-counter skin-lightening preparation with efficacy parity to hydroquinone .
-
-###25374230
-BACKGROUND	Increasing evidence suggests that stromal monocarboxylate transporter 4 ( MCT4 ) and carbonic anhydrase IX ( CA IX ) may play key roles in tumor development .
-BACKGROUND	However , their clinical value remains largely unexplored in gastric cancer ( GC ) .
-BACKGROUND	The present study aimed to determine clinicopathological significance and prognostic values of stromal MCT4 and CA IX in GC .
-METHODS	Specimens from 143 GC patients were immunohistochemically stained using polyclonal anti-MCT4 and anti-CA IX antibodies .
-METHODS	Expression was correlated with patient clinicopathologic characteristics and survival data .
-RESULTS	High stromal MCT4 expression was detected in 72 of 143 ( 50.3 % ) GCs and high CA IX in 74 ( 51.7 % ) .
-RESULTS	Both high stromal MCT4 and CA IX were correlated with advanced TNM stage ( p = 0.000 ; p = 0.000 ) .
-RESULTS	High CA IX expression was positively related to depth of invasion ( p = 0.022 ) and positive lymph nodes ( p = 0.002 ) as well .
-RESULTS	Survival analysis indicated high expression of stromal MCT4 to be an independent factor in predicting poor overall survival ( OS ) ( HR and 95 % CI = 1.962 , 1.032-3 .729 , p = 0.040 ) and disease free survival ( DFS ) ( HR and 95 % CI = 2.081 , 1.158-3 .741 , p = 0.014 ) of GC patients .
-RESULTS	However , high CA IX expression exhibited no significant predictive value .
-CONCLUSIONS	These findings suggest that high expression of stromal MCT4 and CA IX proteins is significantly correlated with GC progression .
-CONCLUSIONS	High stromal MCT4 heralds worse outcome of GC patient , suggesting a novel candidate prognostic marker and therapeutic target .
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-###25916135
-OBJECTIVE	To study the prevalence of H. pylori CagA strain and the activity of associated gastritis in schoolchildren of Tyva Republic ( Russia ) .
-METHODS	The cohorts had been formed out of 1064 native and alien schoolchildren picked up by random in Tyva Republic in the ages from 7 to 17 years .
-METHODS	We determined IgG to H. pylori CagA antigen in serum ( 106 aliens and 112 natives ) .
-METHODS	Out them 59 Tuvins and 72 Europoids with dyspeptic complaints were provided with endoscopic tests including biopsy of mucosa of antrum and stomach body .
-RESULTS	We had found ethnic peculiarities in the obtained indices in children , namely higher prevalence of the said strain of H. pylori and the absence of meaningful activity in antral sector and body of stomach in CagA-seropositive native children as compared to alien ones , in whom the activity of antral gastritis was higher than the activity in body of stomach .
-
-###24814814
-OBJECTIVE	To compare isoflurane and propofol for maintenance of anesthesia and quality of recovery in client-owned dogs with intracranial disease undergoing magnetic resonance imaging ( MRI ) .
-METHODS	Prospective , randomized , clinical trial .
-METHODS	Twenty-five client-owned dogs with intracranial pathology , 13 females and 12 males , ages 11months to 13years , weighing between 3.0 and 48.0 kg .
-METHODS	Each dog was randomly assigned to receive propofol or isoflurane for maintenance of anesthesia .
-METHODS	All dogs were not premedicated , were administered propofol intravenously to effect for induction , intubated and mechanically ventilated to maintain an end-tidal carbon dioxide tension 30-35mmHg ( 4.0-4 .7 kPa ) .
-METHODS	Temperature and cardiac output were measured pre - and post-MRI .
-METHODS	Scores for mentation , neurological status , ease of maintenance , and recovery were obtained pre - and post-anesthesia .
-METHODS	Pulse oximetry , end-tidal gases , arterial blood pressure , heart rate ( HR ) and requirements for dopamine administration to maintain mean arterial pressure ( MAP ) > 60mmHg were recorded throughout anesthesia .
-RESULTS	End-tidal isoflurane concentration was 0.730.35 % and propofol infusion rate was 292119gkg ( -1 ) minute ( -1 ) .
-RESULTS	Cardiac index was higher , while HR was lower , with propofol than isoflurane in dogs younger than 5years , but not in older dogs .
-RESULTS	Dogs maintained with isoflurane were 14.7 times more likely to require dopamine than propofol dogs .
-RESULTS	Mentation and maintenance scores and temperature were not different .
-RESULTS	MAP and diastolic arterial pressure were higher in the propofol group .
-RESULTS	Recovery scores were better with propofol , although times to extubation were similar .
-RESULTS	Change in neurological score from pre - to post-anesthesia was not different between treatments .
-CONCLUSIONS	Dogs maintained with propofol during MRI had higher arterial pressures , decreased requirements for dopamine , and better recovery scores , compared to dogs maintained with isoflurane .
-CONCLUSIONS	Propofol anesthesia offered cardiovascular and recovery advantages over isoflurane during MRI in dogs with intracranial disease in this study .
-
-###24551191
-OBJECTIVE	This study reported on correlates of parental perception of their child 's weight status .
-OBJECTIVE	Associations between parental misperception ( i.e. , underestimation of the child 's weight ) and parental intention to improve their child 's overweight-related health behaviors and their child meeting guidelines regarding these behaviors were also investigated .
-METHODS	Baseline data from the population-based ` Be active , eat right study ' were used .
-METHODS	The population for analysis consisted of 630 overweight and 153 obese five year-old children and their parents .
-METHODS	Questionnaires were used to measure parental perception of the child 's weight status , correlates of misperception ( i.e. , child age , child gender , child BMI , parental age , parental gender , parental country of birth , parental educational level and parental weight status ) , overweight-related health behaviors ( i.e. , child playing outside , having breakfast , drinking sweet beverages , and watching TV ) , and parental intention to improve these behaviors .
-METHODS	Height and weight were measured using standardized protocols .
-METHODS	Multivariable logistic regression analyses were performed .
-RESULTS	In total , 44.40 % of the parents misperceived their child 's weight status .
-RESULTS	Parental misperception was associated with lower child BMI , the parent being the father , a foreign parental country of birth , and a lower parental education level ( p < 0.05 ) .
-RESULTS	Parental misperception was not associated with parental intention to improve child overweight-related health behavior , nor with child meeting the guidelines of these behaviors .
-CONCLUSIONS	This study showed that almost half of the parents with an overweight or obese child misperceived their child 's weight status .
-CONCLUSIONS	A correct parental perception may be a small stepping-stone in improving the health of overweight and obese children .
-
-###25458326
-OBJECTIVE	To assess the beneficial effects of the components of lifestyle intervention in reducing incidence of diabetes in Asian Indian men with impaired glucose tolerance ( IGT ) in India .
-METHODS	This analysis was based on a 2 year prospective , randomized controlled primary prevention trial in a cohort of Asian Indian men with IGT ( n = 537 ) ( Clinical Trial No : NCT00819455 ) .
-METHODS	Intervention and control groups were given standard care advice at baseline .
-METHODS	Additionally , the intervention group received frequent , mobile phone based text message reminders on healthy lifestyle principles .
-METHODS	Dietary intake and physical activity habits were recorded by validated questionnaires .
-METHODS	The lifestyle goals were : reductions in consumption of carbohydrates , oil , portion size and body mass index of at least 1 unit ( 1 kg/m ( 2 ) ) from baseline and maintenance of good physical activity .
-METHODS	The association between diabetes and lifestyle goals achieved was assessed using multiple logistic regression analyses .
-METHODS	Changes in insulin sensitivity ( Matsuda 's insulin sensitivity index ) and oral disposition index during the follow-up were assessed .
-RESULTS	At the end of the study , 123 ( 23.8 % ) participants developed diabetes .
-RESULTS	The mean lifestyle score was higher in the intervention group compared with control ( 2.59 1.13 vs. 2.28 1.17 ; P = 0.002 ) .
-RESULTS	Among the 5 lifestyle variables , significant improvements in the 3 dietary goal were seen with intervention .
-RESULTS	Concomitant improvement in insulin sensitivity and oral disposition index was noted .
-RESULTS	Higher lifestyle score was associated with lower risk of developing diabetes ( odds ratio : 0.54 [ 95 % CI : 0.44-0 .70 ] ; P < 0.0001 ) .
-CONCLUSIONS	Beneficial effects of intervention were associated with increased compliance to lifestyle goals .
-CONCLUSIONS	The plausible mechanism is through improvement in insulin sensitivity and beta cell preservation .
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-###24325112
-OBJECTIVE	To investigate the safety and efficay of low-dose furosemide in the correction of oliguria in the patients undergoing gynecologic surgery .
-METHODS	A total of 120 patients , aged between 20 to 50 years old , who were scheduled to receive elective gynecological open surgery under general anesthesia , were randomly divided into 3 groups : the control group , furosemide 0.05 mg/kg ( F0 .5 ) group and furosemide 0.1 mg/kg ( F1 ) group ( n = 40 ) .
-METHODS	During surgery , blood volume and blood pressure was maintained in the normal range .
-METHODS	The urine volume was recorded every 30 minutes .
-METHODS	Oliguria was defined as the urine volume less than 0.5 mL / ( kg .
-METHODS	h ) , When oliguria was observed , flurosemide or saline was given to the patients based on the enrollment status .
-METHODS	If the patients were still oliguric 30 min later , the treatment was repeated .
-METHODS	The total time of surgery , net fluid infusion volume , urine volume per unit time per body weight at the completion of surgery , the incidence of intraoperative oliguria , the total amount of furosemide and the average specific gravity of urine were recorded .
-RESULTS	There was no statistically significant difference in sex , age , fasting time , the total time of surgery and intraoperative net fluid infusion volume among the three groups ( P > 0.05 ) .
-RESULTS	The urine volume per unit time per body weight in control group was significantly lower than that of the other two groups ( P < 0.01 ) .
-RESULTS	The incidence of intraoperative oliguria in the three groups ( control , low dose , high dose groups ) were 52.5 % , 12.5 % and 0 % , respectively ( P < 0.01 ) .
-CONCLUSIONS	Low-dose of furosemide could maintain normal urine volume and specific gravity of urine during gynecological surgery .
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-###25540891
-BACKGROUND	Ebola virus and Marburg virus cause serious disease outbreaks with high case fatality rates .
-BACKGROUND	We aimed to assess the safety and immunogenicity of two investigational DNA vaccines , one ( EBO vaccine ) encoding Ebola virus Zaire and Sudan glycoproteins and one ( MAR ) encoding Marburg virus glycoprotein .
-METHODS	RV 247 was a phase 1b , double-blinded , randomised , placebo-controlled clinical trial in Kampala , Uganda to examine the safety and immunogenicity of the EBO and MAR vaccines given individually and concomitantly .
-METHODS	Healthy adult volunteers aged 18-50 years were randomly assigned ( 5:1 ) to receive three injections of vaccine or placebo at weeks 0 , 4 , and 8 , with vaccine allocations divided equally between three active vaccine groups : EBO vaccine only , MAR vaccine only , and both vaccines .
-METHODS	The primary study objective was to investigate the safety and tolerability of the vaccines , as assessed by local and systemic reactogenicity and adverse events .
-METHODS	We also assessed immunogenicity on the basis of antibody responses ( ELISA ) and T-cell responses ( ELISpot and intracellular cytokine staining assays ) 4 weeks after the third injection .
-METHODS	Participants and investigators were masked to group assignment .
-METHODS	Analysis was based on the intention-to-treat principle .
-METHODS	This trial is registered at ClinicalTrials.gov , number NCT00997607 .
-RESULTS	108 participants were enrolled into the study between Nov 2 , 2009 , and April 15 , 2010 .
-RESULTS	All 108 participants received at least one study injection ( including 100 who completed the injection schedule ) and were included in safety and tolerability analyses ; 107 for whom data were available were included in the immunogenicity analyses .
-RESULTS	Study injections were well tolerated , with no significant differences in local or systemic reactions between groups .
-RESULTS	The vaccines elicited antibody and T-cell responses specific to the glycoproteins received and we detected no differences between the separate and concomitant use of the two vaccines .
-RESULTS	17 of 30 ( 57 % , 95 % CI 37-75 ) participants in the EBO vaccine group had an antibody response to the Ebola Zaire glycoprotein , as did 14 of 30 ( 47 % , 28-66 ) in the group that received both vaccines .
-RESULTS	15 of 30 ( 50 % , 31-69 ) participants in the EBO vaccine group had an antibody response to the Ebola Sudan glycoprotein , as did 15 of 30 ( 50 % , 31-69 ) in the group that received both vaccines .
-RESULTS	Nine of 29 ( 31 % , 15-51 ) participants in the MAR vaccine groups had an antibody response to the Marburg glycoprotein , as did seven of 30 ( 23 % , 10-42 ) in the group that received both vaccines .
-RESULTS	19 of 30 ( 63 % , 44-80 ) participants in the EBO vaccine group had a T-cell response to the Ebola Zaire glycoprotein , as did 10 of 30 ( 33 % , 17-53 ) in the group that received both vaccines .
-RESULTS	13 of 30 ( 43 % , 25-63 ) participants in the EBO vaccine group had a T-cell response to the Ebola Sudan glycoprotein , as did 10 of 30 ( 33 % , 17-53 ) in the group that received both vaccines .
-RESULTS	15 of 29 ( 52 % , 33-71 ) participants in the MAR vaccine group had a T-cell response to the Marburg glycoprotein , as did 13 of 30 ( 43 % , 25-63 ) in the group that received both vaccines .
-CONCLUSIONS	This study is the first Ebola or Marburg vaccine trial done in Africa , and the results show that , given separately or together , both vaccines were well tolerated and elicited antigen-specific humoral and cellular immune responses .
-CONCLUSIONS	These findings have contributed to the accelerated development of more potent Ebola virus vaccines that encode the same wild-type glycoprotein antigens as the EBO vaccine , which are being assessed during the 2014 Ebola virus disease outbreak in west Africa .
-BACKGROUND	US Department of Defense Infectious Disease Clinical Research Program and US National Institutes of Health Intramural Research Program .
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-###25304298
-BACKGROUND	Cure of lung cancer is impossible without local tumour control .
-BACKGROUND	This can be compromised by accelerated repopulation of tumour cells during radiotherapy and chemotherapy .
-BACKGROUND	A strategy to minimise accelerated repopulation might improve local control .
-BACKGROUND	We investigated whether concurrent chemo-radiotherapy could be given safely over four weeks .
-METHODS	We conducted a randomised phase II trial in which patients with inoperable Stage III Non-Small Cell Lung Cancer ( NSCLC ) received a radical radiation dose over four weeks rather than conventional fractionation .
-METHODS	Treatment was given either sequentially or concurrently with three to four cycles of cisplatinum and vinorelbine .
-METHODS	130 patients with inoperable stage III NSCLC and PS 0-1 were randomised to receive cisplatinum and vinorelbine with either sequential or concurrent chemo-radiation using 55Gy in 20 fractions over four weeks .
-METHODS	The primary end-point was treatment related mortality .
-METHODS	Secondary end-points were toxicity and survival .
-RESULTS	Treatment related mortality was : 2.9 % ( exact 95 % confidence interval [ CI ] 0.36-10 .2 % ) and 1.7 % ( exact 95 % CI 0.043-9 .1 % ) for the Concurrent and Sequential group respectively ; relative risk ( RR ) 1.25 ; ( 95 % CI 0.55 , 2.84 ) .
-RESULTS	Toxicity was similar between arms ; grade 3 or worse oesophagitis was 8.8 % versus 8.5 % ; RR 1.02 ( 95 % CI 0.58 , 1.79 ) .
-RESULTS	OS HR was 0.92 ; 95 % CI ( 0.60-1 .39 ; p = 0.682 ) .
-RESULTS	The 2 year overall survival rates were : 50 % versus 46 % ; RR 1.06 ( 95 % CI 0.77 , 1.46 ) for Concurrent versus Sequential .
-CONCLUSIONS	A strategy to minimise the effects of accelerated repopulation using accelerated hypofractionated radiotherapy with chemotherapy is feasible , and reasonably safe for patients with stage III NSCLC .
-CONCLUSIONS	The reported two year survival is promising and suggests that a four week regime of radiotherapy should be compared with conventionally fractionated radiotherapy in an adequately powered randomised controlled phase III trial .
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-###25296647
-OBJECTIVE	In this paper , we describe a trial protocol used to assess feasibility related to : study administration ( recruitment , randomization , retention , compliance , eligibility criteria , suitability of protocol instructions and data collection questionnaires ) ; resource and data management ( suitability of site , time and budget allocation , management of personnel and data ) ; intervention fidelity ( treatment dose , violations ) ; and effect size .
-BACKGROUND	Pressure injury can lead to increases in hospital length of stay and cost .
-BACKGROUND	The sacrum is identified as one of the most common anatomical pressure injury sites for hospitalized patients .
-BACKGROUND	Silicone foam border dressings have been proposed as one strategy to reduce pressure injury incidence ; however , rigorous testing of benefit in a general medical-surgical population is required .
-METHODS	Randomized controlled trial .
-METHODS	Eighty patients will be recruited after assessment of high risk of pressure injury in a large tertiary hospital in south-east Queensland , Australia .
-METHODS	Eligible , consenting participants will be randomly allocated to either a control group ( routine care ) or an intervention group ( routine care and a sacral prophylactic dressing ) .
-METHODS	The primary outcomes comprise feasibility criteria as identified above .
-METHODS	The secondary measure is the presence and severity of sacral pressure injury via blind assessment of digital photographs .
-METHODS	Research ethics approval was received in October 2013 .
-CONCLUSIONS	Prophylactic dressings applied to the sacrum may be an effective method for reducing pressure injury in high-risk general medical-surgical patients .
-CONCLUSIONS	However , more rigorous studies to confirm benefit are required .
-CONCLUSIONS	This pilot study will determine the feasibility and effect size to inform a larger randomized controlled trial .
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-###24423146
-BACKGROUND	Group cognitive behavioural intervention ( CBI ) is effective in reducing low-back pain and disability in comparison to advice in primary care .
-BACKGROUND	The aim of this analysis was to investigate the impact of compliance on estimates of treatment effect and to identify factors associated with compliance .
-METHODS	In this multicentre trial , 701 adults with troublesome sub-acute or chronic low-back pain were recruited from 56 general practices .
-METHODS	Participants were randomised to advice ( control n = 233 ) or advice plus CBI ( n = 468 ) .
-METHODS	Compliance was specified a priori as attending a minimum of three group sessions and the individual assessment .
-METHODS	We estimated the complier average causal effect ( CACE ) of treatment .
-RESULTS	Comparison of the CACE estimate of the mean treatment difference to the intention-to-treat ( ITT ) estimate at 12 months showed a greater benefit of CBI amongst participants compliant with treatment on the Roland Morris Questionnaire ( CACE : 1.6 points , 95 % CI 0.51 to 2.74 ; ITT : 1.3 points , 95 % CI 0.55 to 2.07 ) , the Modified Von Korff disability score ( CACE : 12.1 points , 95 % CI 6.07 to 18.17 ; ITT : 8.6 points , 95 % CI 4.58 to 12.64 ) and the Modified von Korff pain score ( CACE : 10.4 points , 95 % CI 4.64 to 16.10 ; ITT : 7.0 points , 95 % CI 3.26 to 10.74 ) .
-RESULTS	People who were non-compliant were younger and had higher pain scores at randomisation .
-CONCLUSIONS	Treatment compliance is important in the effectiveness of group CBI .
-CONCLUSIONS	Younger people and those with more pain are at greater risk of non-compliance .
-BACKGROUND	Current Controlled Trials ISRCTN54717854 .
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-###25071901
-OBJECTIVE	The use of proton pump inhibitors or misoprostol is known to prevent the gastrointestinal complications of nonsteroidal anti-inflammatory drugs ( NSAIDs ) .
-OBJECTIVE	Rebamipide is known to increase the mucosal generation of prostaglandins and to eliminate free oxygen radicals , thus enhancing the protective function of the gastric mucosa .
-OBJECTIVE	However , it is unknown whether rebamipide plays a role in preventing NSAID-induced gastropathy .
-OBJECTIVE	The aim of this study was to determine the effectiveness of rebamipide compared to misoprostol in preventing NSAID-induced gastrointestinal complications in patients requiring continuous NSAID treatment .
-METHODS	We studied 479 patients who required continuous NSAID treatment .
-METHODS	The patients were randomly assigned to groups that received 100 mg of rebamipide three times per day or 200 g of misoprostol three times per day for 12 weeks .
-METHODS	The primary endpoint of the analysis was the occurrence rate of gastric ulcers , as determined by endoscopy after 12 weeks of therapy .
-RESULTS	Of the 479 patients in the study , 242 received rebamipide , and 237 received misoprostol .
-RESULTS	Ultimately , 44 patients ( 18.6 % ) withdrew from the misoprostol group and 25 patients ( 10.3 % ) withdrew from the rebamipide group .
-RESULTS	There was a significant difference in withdrawal rate between the two groups ( p = 0.0103 ) .
-RESULTS	The per protocol analysis set was not valid because of the dropout rate of the misoprostol group ; thus , the intention to treat ( ITT ) analysis set is the main set for the efficacy analysis in this study .
-RESULTS	After 12 weeks , the occurrence rate of gastric ulcers was similar in the rebamipide and misoprostol groups ( 20.3 % vs 21.9 % , p = 0.6497 ) according to ITT analysis .
-RESULTS	In addition , the therapeutic failure rate was similar in the rebamipide and misoprostol groups ( 13.6 % vs 13.1 % , p = 0.8580 ) .
-RESULTS	The total severity score of the gastrointestinal symptoms was significantly lower in the rebamipide group than in the misoprostol group ( p = 0.0002 ) .
-RESULTS	The amount of antacid used was significantly lower in the rebamipide group than in the misoprostol group ( p = 0.0258 ) .
-CONCLUSIONS	Rebamipide can prevent gastric ulcers when used with NSAIDs and can decrease the gastrointestinal symptoms associated with NSAID administration .
-CONCLUSIONS	When the possibility of poor compliance and the potential adverse effects of misoprostol are considered , rebamipide appears to be a clinically effective and safe alternative .
-
-###24813026
-OBJECTIVE	The purpose of this study was to evaluate the efficacy and safety of duloxetine flexible dose in children ( 7-11 years ) and adolescents ( 12-17 years ) with major depressive disorder ( MDD ) .
-METHODS	Patients ( n = 337 ) in this 36 week study ( 10 week acute and 26 week extension treatment ) received duloxetine ( 60-120mg once daily [ QD ] , n = 117 ) , fluoxetine ( 20-40mg QD , n = 117 ) , or placebo ( n = 103 ) .
-METHODS	Measures included : Children 's Depression Rating Scale-Revised ( CDRS-R ) , treatment-emergent adverse events ( TEAEs ) , and Columbia-Suicide Severity Rating Scale ( C-SSRS ) .
-RESULTS	Neither active drug ( duloxetine or fluoxetine ) separated significantly ( p < 0.05 ) from placebo on mean change from baseline to end-point ( 10 weeks ) on the CDRS-R total score .
-RESULTS	There were no significant differences between the duloxetine or fluoxetine groups compared with placebo on serious AEs ( SAEs ) , total TEAEs , or discontinuation for AE during acute treatment .
-RESULTS	There were no completed suicides or deaths , and no clinically significant electrocardiogram ( ECG ) abnormalities observed during the study .
-RESULTS	One fluoxetine and one duloxetine patient experienced alanine aminotransferase ( ALT ) three or more times the upper limit of normal , which resolved during the study .
-RESULTS	A total of 8 ( 7.1 % ) duloxetine patients , 7 ( 6.8 % ) placebo patients , and 9 ( 8.0 % ) fluoxetine patients had worsening of suicidal ideation from baseline during acute treatment .
-RESULTS	Of the patients with suicidal ideation at baseline , 15/19 ( 79 % ) duloxetine , 19/19 ( 100 % ) placebo , and 16/19 ( 84 % ) fluoxetine had improvement in suicidal ideation at end-point during acute treatment .
-RESULTS	One duloxetine and two fluoxetine patients had treatment-emergent suicidal behavior during the 36 week study .
-CONCLUSIONS	Trial results were inconclusive , as neither the investigational drug ( duloxetine ) nor the active control ( fluoxetine ) separated from placebo on the CDRS-R at 10 weeks .
-CONCLUSIONS	No new duloxetine safety signals were identified relative to those seen in adults .
-CONCLUSIONS	Clinical Trial Registry Number : NCT00849901 .
-
-###25145522
-BACKGROUND	The 2014 Eighth Joint National Committee panel recommendations for management of high blood pressure ( BP ) recommend a systolic BP threshold for initiation of drug therapy and a therapeutic target of < 150 mm Hg in those60 years of age , a departure from prior recommendations of < 140 mm Hg .
-BACKGROUND	However , it is not known whether this is an optimal choice , especially for the large population with coronary artery disease ( CAD ) .
-OBJECTIVE	This study sought to evaluate optimal BP in patients60 years of age .
-METHODS	Patients 60 years of age or older with CAD and baseline systolic BP > 150 mm Hg randomized to a treatment strategy on the basis of either atenolol/hydrochlorothiazide or verapamil-SR ( sustained release ) / trandolapril in INVEST ( INternational VErapamil SR Trandolapril STudy ) were categorized into 3 groups on the basis of achieved on-treatment systolic BP : group 1 , < 140 mm Hg ; group 2 , 140 to < 150 mm Hg ; and group 3,150 mm Hg .
-METHODS	Primary outcome was first occurrence of all-cause death , nonfatal myocardial infarction ( MI ) , or nonfatal stroke .
-METHODS	Secondary outcomes were all-cause mortality , cardiovascular mortality , total MI , nonfatal MI , total stroke , nonfatal stroke , heart failure , or revascularization , tabulated separately .
-METHODS	Outcomes for each group were compared in unadjusted and multiple propensity score-adjusted models .
-RESULTS	Among 8,354 patients included in this analysis with an accumulated 22,308 patient-years of follow-up , 4,787 ( 57 % ) achieved systolic BP of < 140 mm Hg ( group 1 ) , 1,747 ( 21 % ) achieved systolic BP of 140 to < 150 mm Hg ( group 2 ) , and 1,820 ( 22 % ) achieved systolic BP of150 mm Hg ( group 3 ) .
-RESULTS	In unadjusted models , group 1 had the lowest rates of the primary outcome ( 9.36 % vs. 12.71 % vs. 21.32 % ; p < 0.0001 ) , all-cause mortality ( 7.92 % vs. 10.07 % vs. 16.81 % ; p < 0.0001 ) , cardiovascular mortality ( 3.26 % vs. 4.58 % vs. 7.80 % ; p < 0.0001 ) , MI ( 1.07 % vs. 1.03 % vs. 2.91 % ; p < 0.0001 ) , total stroke ( 1.19 % vs. 2.63 % vs. 3.85 % ; p < 0.0001 ) , and nonfatal stroke ( 0.86 % vs 1.89 % vs 2.86 % ; p < 0.0001 ) compared with groups 2 and 3 , respectively .
-RESULTS	In multiple propensity score-adjusted models , compared with the reference group of < 140 mm Hg ( group 1 ) , the risk of cardiovascular mortality ( adjusted hazard ratio [ HR ] : 1.34 ; 95 % confidence interval [ CI ] : 1.01 to 1.77 ; p = 0.04 ) , total stroke ( adjusted HR : 1.89 ; 95 % CI : 1.26 to 2.82 ; p = 0.002 ) and nonfatal stroke ( adjusted HR : 1.70 ; 95 % CI : 1.06 to 2.72 ; p = 0.03 ) was increased in the group with BP of 140 to < 150 mm Hg , whereas the risk of primary outcome , all-cause mortality , cardiovascular mortality , total MI , nonfatal MI , total stroke , and nonfatal stroke was increased in the group with BP150 mm Hg .
-CONCLUSIONS	In hypertensive patients with CAD who are60 years of age , achieving a BP target of 140 to < 150mm Hg as recommended by the JNC-8 panel was associated with less benefit than the previously recommended target of < 140 mm Hg .
-
-###25991758
-BACKGROUND	After cardiac surgery , patients receive large amounts of fluid in the Intensive Care Unit ( ICU ) .
-BACKGROUND	We plan to conduct a multi-centre randomised controlled trial , of a conservative fluid regime , in patients after cardiac surgery , and have reported results of a feasibility study that evaluated efficacy and safety of the proposed regime .
-METHODS	After ethical approval , a single-centre , prospectively randomised interventional study was undertaken .
-METHODS	Participants were randomised to either usual care , or to a protocolised algorithm , utilising stroke volume variation , to guide fluid administration to patients who were deemed to have inadequate cardiac output and were likely to be volume responsive .
-METHODS	The study protocol lasted from ICU admission to de-sedation or 24 h , whichever occurred first .
-RESULTS	We randomised 144 subjects over 9 months .
-RESULTS	Less bolus fluid and less total overall fluid volume was administered in the intervention group ( median ( IQR ) 1620 ml ( 500-3410 ) and 2525 ml ( 1440-5250 ; P < 0.001 ) , compared with the usual care group ( 2050 ml ( 910-4280 ) and 2980 ml ( 2070-6580 ; P = 0.001 ) , from ICU admission to extubation .
-RESULTS	There was no significant difference in incidence of acute kidney injury or the average amount of fluid administered to the usual care group at the beginning compared with the end of the study .
-CONCLUSIONS	It is both possible and safe to achieve a significant reduction in the amount of fluid administered to patients , allocated to a conservative fluid protocol .
-CONCLUSIONS	These results suggest that a planned multi-centre study is both justified and feasible .
-BACKGROUND	Australia New Zealand Clinical Trials Registry www.anzctr.org.au ( ACTRN12612000754842 ) .
-
-###25588594
-OBJECTIVE	Dexmedetomidine can prolong the duration of local anesthetics , but the effect of retrobulbar dexmedetomidine on the potency of ropivacaine for retrobulbar block has not been investigated .
-OBJECTIVE	Our study was designed to determine the effect of retrobulbar dexmedetomidine on ropivacaine for retrobulbar block in children .
-METHODS	A group of 90 children aged 10-16 years scheduled for vitreoretinal surgery who received retrobulbar block were randomly assigned to 1 of 3 groups : group L ( retrobulbar ropivacaine ) , group LD1 ( ropivacaine plus 0.5 g.kg-1 dexmedetomidine ) , or group LD2 ( ropivacaine plus 1 g.kg-1 dexmedetomidine ) .
-METHODS	The minimum local anesthetic concentration ( MLAC ) was determined according to a Dixon-Massey protocol .
-METHODS	The primary endpoint of the study was MLAC .
-METHODS	Secondary outcomes were duration of postoperative analgesia , postoperative pain scores , dexmedetomidine side effects , and time to hospital discharge .
-RESULTS	The MLAC values of retrobulbar ropivacaine were 0.314 % , 0.259 % , and 0.246 % in groups L , LD1 , and LD2 , respectively .
-RESULTS	The median ( interquartile range ) durations of analgesia in the postoperative period were 66 ( 54-117 ) , 89 ( 40-157 ) , and 168 ( 120-194 ) minutes in groups L , LD1 , and LD2 , respectively ( L vs LD1 or LD2 , p < 0.05 ) .
-RESULTS	Wake-up time was significantly increased in groups LD1 and LD2 .
-CONCLUSIONS	Retrobulbar dexmedetomidine reduces the MLAC values of ropivacaine and improves postoperative analgesia in children without any neurologic side effects .
-
-###25462898
-BACKGROUND	Empathy improves our ability to communicate in social interactions and motivates prosocial behavior .
-BACKGROUND	The neuropeptides arginine vasopressin and oxytocin play key roles in socioemotional processes such as pair bonding and parental care , which suggests that they may be involved in empathic processing .
-METHODS	We investigated how vasopressin and oxytocin affect empathic responding in a randomized , double-blind , placebo controlled , between-subjects study design .
-METHODS	We also examined the moderating role of parental warmth , as reported in the early family environment , on empathic responding following vasopressin , oxytocin , or placebo administration .
-RESULTS	Among participants who reported higher levels of paternal warmth ( but not maternal warmth ) , vasopressin ( vs. placebo and oxytocin ) increased ratings of empathic concern after viewing distressing and uplifting videos .
-RESULTS	No main or interaction effects were found for individuals who received oxytocin .
-CONCLUSIONS	Vasopressin has a role in enhancing empathy among individuals who received higher levels of paternal warmth .
-BACKGROUND	NCT01680718 .
-
-###24840511
-OBJECTIVE	Levels of stool fatty acid soaps and beneficial bacteria differ between formula-fed and breast-fed infants ; addition of specific formula ingredients may reduce these differences .
-OBJECTIVE	This study evaluated the effects of a term infant formula containing high sn-2 palmitate term infant formula ( sn-2 ) or an identical formula supplemented with oligofructose ( OF ) at 2 concentrations ( sn-2 +3 g/L OF , sn-2 +5 g/L OF ) on stool composition , stool characteristics , and fecal bifidobacteria .
-METHODS	Healthy , term formula-fed infants 7 to 14 days old ( n = 300 ) were randomized in a double-blind manner to receive standard formula ( control ) , sn-2 , sn-2 +3 g/L OF , or sn-2 +5 g/L OF for 8 weeks .
-METHODS	Human milk ( HM ) - fed infants ( n = 75 ) were studied in parallel .
-METHODS	Stool samples were collected from all subjects at week 8 for fatty acid soaps and mineral content , and from a subset at baseline and week 8 for bifidobacteria .
-METHODS	Stool characteristics were assessed via 3-day diary .
-RESULTS	The sn-2 group had 46 % less stool soap palmitate ( P < 0.001 ) and softer stools than control ( 20 % more mushy soft stools , P = 0.026 ; 50 % fewer formed stools , P = 0.003 ) .
-RESULTS	Addition of OF resulted in even fewer formed stools versus control ( 65 % fewer for sn-2 +3 g/L OF , 79 % fewer for sn-2 +5 g/L OF ) , with 5 g/L OF more closely resembling that of HM-fed infants .
-RESULTS	Both sn-2 ( P < 0.05 ) and sn-2 with OF groups ( P < 0.01 ) had significantly higher fecal bifidobacteria concentrations than control at week 8 , not differing from HM-fed infants .
-CONCLUSIONS	High sn-2-palmitate formulas led to reduced stool soaps , softer stools , and increased bifidobacteria , whereas addition of OF further improved stool consistency .
-CONCLUSIONS	Those modifications brought outcomes in formula-fed infants closer to that in HM-fed infants .
-
-###24560332
-BACKGROUND	Targeting the epidermal-growth-factor-receptor ( EGFR ) in non-small cell lung cancer ( NSCLC ) is an established treatment option with less toxicity compared to conventional chemotherapy .
-BACKGROUND	This study was undertaken to determine whether Erlotinib is non-inferior compared to chemotherapy as a first-line therapy in unselected elderly patients .
-METHODS	Patients 70 years with untreated , metastatic NSCLC were randomized to Erlotinib ( E ) , 150 mg/day or Carboplatin ( AUC5 ) plus Vinorelbine ( 25mg/m ( 2 ) on days 1 and 8 ) every three weeks ( CV ) .
-METHODS	Primary endpoint was progression-free survival ( PFS ) .
-METHODS	After progression , crossover was strongly recommended .
-METHODS	Secondary endpoints were duration of response , 1-year survival , overall survival ( OS ) , response rate ( RR ) , quality of life ( FACT-L ) , assessment of comorbidities by simplified comorbidity score ( SCS ) and Charlsons ' comorbidity score , safety and assessment of molecular markers .
-RESULTS	Between June 2006 and August 2008 284 pts were randomized to E ( 144 ) and CV ( 140 ) .
-RESULTS	PFS was significantly inferior with E ( median PFS 2.4 versus 4.6 months [ HR 1.6 , 75 % CI 1.22-2 .09 , p : 0.0005 ] ) as well as RR ( 7.8 % v 28.3 % , p : 0.0001 ) .
-RESULTS	No significant difference in OS appeared ( median E : 7.3 months versus CV : 8.4 months , HR : 1.24 [ 75 % CI 0.9-1 .71 ] ) .
-RESULTS	In never smokers PFS ( median PFS : 3.7 v 4.3 m , E v CV , HR 0.72 , 75 % CI 0.35-1 .48 ) and OS ( median : 16.5 versus 17 months , HR 0.99 [ 75 % CI 0.38-2 .57 ] ) were comparable .
-RESULTS	More skin toxicity and diarrhea was seen with E compared to more myelotoxicity , neurotoxicity and constipation with CV .
-RESULTS	Less severe adverse events were observed with E ( 81 v 102 , E v CV ) .
-CONCLUSIONS	CV had an increased efficacy compared with E in an unselected population of elderly patients with advanced NSCLC .
-
-###24508103
-BACKGROUND	In the BRIM-3 trial , vemurafenib was associated with risk reduction versus dacarbazine of both death and progression in patients with advanced BRAF ( V600 ) mutation-positive melanoma .
-BACKGROUND	We present an extended follow-up analysis of the total population and in the BRAF ( V600E ) and BRAF ( V600K ) mutation subgroups .
-METHODS	Patients older than 18 years , with treatment-naive metastatic melanoma and whose tumour tissue was positive for BRAF ( V600 ) mutations were eligible .
-METHODS	Patients also had to have a life expectancy of at least 3 months , an Eastern Cooperative Oncology Group ( ECOG ) performance status of 0 or 1 , and adequate haematological , hepatic , and renal function .
-METHODS	Patients were randomly assigned by interactive voice recognition system to receive either vemurafenib ( 960 mg orally twice daily ) or dacarbazine ( 1000 mg/m ( 2 ) of body surface area intravenously every 3 weeks ) .
-METHODS	Coprimary endpoints were overall survival and progression-free survival , analysed in the intention-to-treat population ( n = 675 ) , with data censored at crossover .
-METHODS	A sensitivity analysis was done .
-METHODS	This trial is registered with ClinicalTrials.gov , NCT01006980 .
-RESULTS	675 eligible patients were enrolled from 104 centres in 12 countries between Jan 4 , 2010 , and Dec 16 , 2010.337 patients were randomly assigned to receive vemurafenib and 338 to receive dacarbazine .
-RESULTS	Median follow-up was 125 months ( IQR 77-160 ) on vemurafenib and 95 months ( 31-147 ) on dacarbazine .
-RESULTS	83 ( 25 % ) of the 338 patients initially randomly assigned to dacarbazine crossed over from dacarbazine to vemurafenib .
-RESULTS	Median overall survival was significantly longer in the vemurafenib group than in the dacarbazine group ( 136 months [ 95 % CI 120-152 ] vs 97 months [ 79-128 ] ; hazard ratio [ HR ] 070 [ 95 % CI 057-087 ] ; p = 00008 ) , as was median progression-free survival ( 69 months [ 95 % CI 61-70 ] vs 16 months [ 16-21 ] ; HR 038 [ 95 % CI 032-046 ] ; p < 00001 ) .
-RESULTS	For the 598 ( 91 % ) patients with BRAF ( V600E ) disease , median overall survival in the vemurafenib group was 133 months ( 95 % CI 119-149 ) compared with 100 months ( 80-140 ) in the dacarbazine group ( HR 075 [ 95 % CI 060-093 ] ; p = 00085 ) ; median progression-free survival was 69 months ( 95 % CI 62-70 ) and 16 months ( 16-21 ) , respectively ( HR 039 [ 95 % CI 033-047 ] ; p < 00001 ) .
-RESULTS	For the 57 ( 9 % ) patients with BRAF ( V600K ) disease , median overall survival in the vemurafenib group was 145 months ( 95 % CI 112-not estimable ) compared with 76 months ( 61-166 ) in the dacarbazine group ( HR 043 [ 95 % CI 021-090 ] ; p = 0024 ) ; median progression-free survival was 59 months ( 95 % CI 44-90 ) and 17 months ( 14-29 ) , respectively ( HR 030 [ 95 % CI 016-056 ] ; p < 00001 ) .
-RESULTS	The most frequent grade 3-4 events were cutaneous squamous-cell carcinoma ( 65 [ 19 % ] of 337 patients ) and keratoacanthomas ( 34 [ 10 % ] ) , rash ( 30 [ 9 % ] ) , and abnormal liver function tests ( 38 [ 11 % ] ) in the vemurafenib group and neutropenia ( 26 [ 9 % ] of 287 patients ) in the dacarbazine group .
-RESULTS	Eight ( 2 % ) patients in the vemurafenib group and seven ( 2 % ) in the dacarbazine group had grade 5 events .
-CONCLUSIONS	Inhibition of BRAF with vemurafenib improves survival in patients with the most common BRAF ( V600E ) mutation and in patients with the less common BRAF ( V600K ) mutation .
-BACKGROUND	F Hoffmann-La Roche-Genentech .
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-###24773418
-OBJECTIVE	This study investigated the effect of exposure to television food advertising on accessibility of food-related cognitions and motivation to eat .
-METHODS	We initially developed a word stem completion task to measure accessibility of food-related cognitions .
-METHODS	In two subsequent experiments , 160 female undergraduate students ( Experiment 1 ) and 124 overweight or obese community-dwelling women ( Experiment 2 ) viewed a series of television commercials advertising either food or non-food products .
-METHODS	They then completed the word stem task and also rated their desire to eat .
-RESULTS	Exposure to televised food advertisements led to the completion of word stems with more food - and eating-related words in both experiments .
-RESULTS	It also increased self-reported desire to eat , but only for overweight and obese individuals ( Experiment 2 ) .
-RESULTS	In both samples , there was a positive association between accessibility of food-related cognitions and reported desire to eat , following priming with television food advertisements .
-CONCLUSIONS	We conclude that an increased activation of food-related cognitions may provide a mechanism for the link between food advertising and consumption .
-CONCLUSIONS	This has implications for tackling pathological ( over ) eating .
-
-###24916838
-BACKGROUND	The study aims to determine whether the route of insulin administration influences glycaemic variability and inflammatory or neurohormonal markers in patients with type 2 diabetes and congestive heart failure ( CHF ) exacerbation .
-METHODS	Patients ( n = 65 ) were randomized to intravenous ( IV ) insulin ( duration 48 h ) or subcutaneous ( SQ ) insulin .
-METHODS	Inflammatory cytokines and markers of lipid oxidation , high-frequency heart rate variability ( n = 27 ) and cardiac impedance ( pre-ejection period , n = 28 ) were used to estimate parasympathetic and sympathetic tone in patients with valid cardiac data .
-METHODS	Glycaemic variability was measured using a continuous glucose monitor .
-RESULTS	Mean glucose was lower ( 7.71.2 vs 9.42.7 mmol/L , p = 0.004 ) , coefficient of variation was higher ( p = 0.03 ) and glycaemic lability index was similar on day 1 in the IV group compared with the SQ group , but groups were similar by day 2 .
-RESULTS	The IV group had more confirmed hypoglycaemia ( p = 0.005 ) .
-RESULTS	There were no differences in hospital readmission or hospital length of stay between groups .
-RESULTS	There were no differences in CHF biomarkers , heart rate variability or pre-ejection period between groups .
-RESULTS	Increasing log glycaemic lability index was associated with lower on-treatment pre-ejection period ( p = 0.03 ) while increasing coefficient of variation was associated with increasing brain natriuretic peptide ( p = 0.004 ) and paroxonase-1 ( p = 0.02 ) .
-RESULTS	Other univariable analyses were not significant .
-CONCLUSIONS	There were modest , transient differences in glucose control between IV and SQ insulin in hospitalized CHF patients .
-CONCLUSIONS	However , the analyses do not support a link between insulin route and inflammatory markers or autonomic tone .
-CONCLUSIONS	Further study is needed to assess outcomes in hospitalized CHF patients .
-
-###24607003
-BACKGROUND	New vaccines containing highly conserved Streptococcus pneumoniae proteins such as pneumolysin toxoid ( dPly ) and histidine-triad protein D ( PhtD ) are being developed to provide broader protection against pneumococcal disease .
-BACKGROUND	This study evaluated the safety , reactogenicity and immunogenicity of different pneumococcal protein-containing formulations in adults .
-METHODS	In a phase I double-blind study ( www.clinicaltrials.gov : NCT00707798 ) , healthy adults ( 18-40 years ) were randomized ( 1:2:2:2:2:2:2 ) to receive two doses of one of six investigational vaccine formulations 2 months apart , or a single dose of the control 23-valent pneumococcal polysaccharide vaccine ( 23PPV ; Pneumovax23 , Sanofi Pasteur MSD ) followed by placebo .
-METHODS	The investigational formulations contained dPly alone ( 10 or 30 g ) , or both dPly and PhtD ( 10 or 30 g each ) alone or combined with the polysaccharide conjugates of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine ( PHiD-CV ; Synflorix , GlaxoSmithKline Vaccines ) .
-METHODS	Two groups primed with a formulation containing dPly and PhtD ( 10 or 30 g each ) continued to the follow-up phase II study ( NCT00896064 ) , in which they received a booster dose at 5-9 months after primary vaccination .
-RESULTS	Of 156 enrolled and vaccinated adults , 146 completed the primary immunization and 43 adults received a booster dose .
-RESULTS	During primary and booster vaccination , for any formulation , 8.9 % of doses were followed by grade 3 solicited local or general adverse events .
-RESULTS	No fever > 39.5 C ( oral temperature ) was reported .
-RESULTS	Unsolicited adverse events considered causally related to vaccination were reported following 33.3 % of investigational vaccine doses .
-RESULTS	No serious adverse events were reported for adults receiving investigational vaccine formulations .
-RESULTS	Formulations containing dPly with or without PhtD were immunogenic for these antigens ; polysaccharide conjugate-containing formulations were also immunogenic for those 10 polysaccharides .
-CONCLUSIONS	Investigational vaccine formulations containing dPly and PhtD were well tolerated and immunogenic when administered to healthy adults as standalone protein vaccine or combined with PHiD-CV conjugates .
-
-###25552616
-BACKGROUND	Early identification ( EI ) and brief interventions ( BIs ) for risky drinkers are effective tools in primary care .
-BACKGROUND	Lack of time in daily practice has been identified as one of the main barriers to implementation of BI .
-BACKGROUND	There is growing evidence that facilitated access by primary healthcare professionals ( PHCPs ) to a web-based BI can be a time-saving alternative to standard face-to-face BIs , but there is as yet no evidence about the effectiveness of this approach relative to conventional BI .
-BACKGROUND	The main aim of this study is to test non-inferiority of facilitation to a web-based BI for risky drinkers delivered by PHCP against face-to-face BI .
-METHODS	A randomised controlled non-inferiority trial comparing both interventions will be performed in primary care health centres in Catalonia , Spain .
-METHODS	Unselected adult patients attending participating centres will be given a leaflet inviting them to log on to a website to complete the Alcohol Use Disorders Identification Test ( AUDIT-C ) alcohol screening questionnaire .
-METHODS	Participants with positive results will be requested online to complete a trial module including consent , baseline assessment and randomisation to either face-to-face BI by the practitioner or BI via the alcohol reduction website .
-METHODS	Follow-up assessment of risky drinking will be undertaken online at 3 months and 1 year using the full AUDIT and D5-EQD5 scale .
-METHODS	Proportions of risky drinkers in each group will be calculated and non-inferiority assessed against a specified margin of 10 % .
-METHODS	Assuming reduction of 30 % of risky drinkers receiving standard intervention , 1000 patients will be required to give 90 % power to reject the null hypothesis .
-BACKGROUND	The protocol was approved by the Ethics Commmittee of IDIAP Jordi Gol i Gurina P14/028 .
-BACKGROUND	The findings of the trial will be disseminated through peer-reviewed journals , national and international conference presentations .
-BACKGROUND	ClinicalTrials.gov NCT02082990 .
-
-###24941010
-OBJECTIVE	The hyperglycemic response to surgery may be a risk factor for cognitive dysfunction .
-OBJECTIVE	We hypothesize that strict maintenance of normoglycemia during cardiac surgery preserves postoperative cognitive function .
-METHODS	As part of a larger randomized , single-blind , interventional efficacy study on the effects of hyperinsulinemic glucose control in cardiac surgery ( NCT00524472 ) , consenting patients were randomly assigned to receive combined administration of insulin and glucose , titrated to preserve normoglycemia ( 3.5-6 .1 mmol L ( -1 ) ; experimental group ) , or standard metabolic care ( blood glucose 3.5-10 mmol L ( -1 ) ; control group ) , during open heart surgery .
-METHODS	The patients ' cognitive function was assessed during three home visits , approximately two weeks before the operation , and two months and seven months after surgery .
-METHODS	The following tests were performed : Rey Auditory Verbal Learning Task ( RAVLT for verbal learning and memory ) , Digit Span Task ( working memory ) , Trail Making A & B ( visuomotor tracking and attention ) , and the Word Pair Task ( implicit memory ) .
-METHODS	Questionnaires measuring specific traits known to affect cognitive performance , such as self-esteem , depression , chronic stress and social support , were also administered .
-METHODS	The primary outcome was to assess the effect of hyperinsulinemic-normoglycemic clamp therapy versus standard therapy on specific cognitive parameters in patients receiving normoglycemic clamp , or standard metabolic care .
-RESULTS	Twenty-six patients completed the study with 14 patients in the normoglycemia and 12 patients in the control group .
-RESULTS	Multiple analysis of covariance ( MANCOVA ) for the RAVLT showed a significant effect for the interaction of group by visit ( F = 4.07 , p = 0.035 ) , and group by visit by recall ( F = 2.21 , p = 0.04 ) .
-RESULTS	The differences occurred at the second and third visit .
-RESULTS	MANCOVA for the digit span task , trail making and word pair association test showed no significant effect .
-CONCLUSIONS	Preserving intraoperative normoglycemia by intravenous insulin and glucose may prevent the impairment of memory function , both short and long-term , after cardiac surgery .
-
-###25935830
-BACKGROUND	Cardiovascular disease and cancer are leading causes of mortality for people with a history of alcohol or other substance use disorders .
-BACKGROUND	These chronic diseases share the same four primary behavioural risk factors i.e. excessive alcohol use , smoking , low intake of fruit and vegetables and physical inactivity .
-BACKGROUND	In addition to addressing problematic alcohol use , there is the potential for substance abuse treatment services to also address these other behaviours .
-BACKGROUND	Healthy Recovery is an 8-session group-based intervention that targets these multiple behavioural health risk factors and was developed specifically for people attending substance abuse treatment .
-BACKGROUND	This protocol describes a Cancer Institute NSW funded study that assesses the effectiveness of delivering Healthy Recovery for people who are attending residential alcohol and other substance abuse treatment .
-METHODS	The study uses a stepped wedge randomised controlled design , where randomisation occurs at the service level .
-METHODS	Participants will be recruited from residential rehabilitation programs provided by The Australian Salvation Army .
-METHODS	All participants who ( 1 ) currently smoke tobacco and ( 2 ) are expected to be in the residential program for the duration of the 5-week intervention will be asked to participate in the study .
-METHODS	Those participants residing at the facilities assigned to the treatment condition will complete Healthy Recovery .
-METHODS	The intervention is manual guided and will be delivered over a 5-week period , with participants attending 8 group sessions .
-METHODS	All participants will continue to complete The Salvation Army residential program , a predominantly 12-step based , modified therapeutic community .
-METHODS	Participants in the control condition will complete treatment as usual .
-METHODS	Research staff blind to treatment allocation will complete the primary and secondary outcome assessments at baseline and then at weeks 8 , 20 and 32 weeks post intervention .
-CONCLUSIONS	This study will provide comprehensive data on the effect of delivering a healthy lifestyle intervention ( i.e. Healthy Recovery ) within a residential substance abuse setting .
-CONCLUSIONS	If shown to be effective , this intervention can be disseminated within other residential substance abuse programs .
-BACKGROUND	Australian and New Zealand Clinical Trials Register ( ANZCTR ) : ACTRN12615000165583 .
-BACKGROUND	Registered 19 ( th ) February 2015 .
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-###25068412
-OBJECTIVE	Appropriate pain management may positively affect outcome following hip fractures .
-OBJECTIVE	Positioning patients for spinal anesthesia ( SA ) can be extremely painful .
-OBJECTIVE	Peripheral nerve blockades are gaining popularity in this setting .
-OBJECTIVE	This prospective , randomized study compares the efficacy of fascia iliaca compartment block ( FICB ) to intravenous ( IV ) fentanyl for positioning hip fracture patients for SA .
-METHODS	Forty-one patients scheduled for hip fracture surgery were randomized to receive a bolus dose of IV fentanyl ( IVFE ) 1.5 g/kg ( IVFE group ) or an FICB using 40 mL ropivacaine 0.5 % ( FICB group ) 5 or 20 minutes before positioning for SA , respectively .
-METHODS	Numeric rating pain scale scores before and following the analgesic intervention , time needed and quality of patient position for SA performance , postoperative analgesia in terms of time to first IV morphine dose demand and morphine consumption during the first 24 hours , and patient satisfaction were documented .
-RESULTS	Compared with the IVFE group , the FICB group showed significantly lower numeric rating pain scale scores in all instances following the analgesic intervention ( P < 0.001 ) , shorter spinal performance time ( P = 0.001 ) , and better quality of position ( P = 0.001 ) .
-RESULTS	Postoperative morphine consumption was lower ( P = 0.026 ) , the time to first dose demand was longer ( P = 0.001 ) , and patient satisfaction rates were higher ( P < 0.001 ) in the FICB group .
-CONCLUSIONS	Performing an FICB before positioning for SA provides superior pain management compared with IVFE administration , facilitates spinal performance , and yields satisfactory postoperative analgesia and wide patient acceptance , hence improving overall quality and efficiency of care .
-
-###24837000
-OBJECTIVE	To determine the psychometric properties of an observational scale of anxiety .
-METHODS	A cross-sectional and longitudinal survey with stroke survivor-carer dyads .
-METHODS	Eighty-nine dyads recruited in community stroke groups completed : a demographic questionnaire ; the Behavioural Outcomes of Anxiety scale ( BOA ) , survivor-rated ( survivor BOA ) and carer-rated ( carer BOA ) versions ; the anxiety scale of the Hospital Anxiety and Depression Scales ( HADS-A ) , also in carer and survivor versions .
-METHODS	Twenty-seven survivors and carers repeated the BOA after 1 week .
-RESULTS	Correlations between the carer BOA and the survivor HADS-A ( r = .55 , p < .001 ) and the survivor BOA ( r = .73 , p < .001 ) demonstrated construct validity .
-RESULTS	Cronbach 's alpha for the carer BOA was .81 ; item statistics did not identify any items for exclusion .
-RESULTS	The test-retest coefficient at 1 week was 0.83 .
-RESULTS	Receiver operating characteristic analysis against the survivor HADS-A and BOA produced areas under the curve of 0.75 and 0.88 , respectively .
-RESULTS	At a cut-off score of 13/14 sensitivity and specificity against the HADS-A were 0.77 and 0.58 , respectively , and 0.86 and 0.68 against the survivor BOA .
-RESULTS	The impact of stroke on memory was associated with elevated anxiety .
-RESULTS	Scores for both BOA versions were independent of demographic variables .
-CONCLUSIONS	The carer BOA has acceptable psychometric properties and is independent of survivor demographic variables such as age .
-CONCLUSIONS	It identifies self-reported cases with acceptable sensitivity and specificity .
-CONCLUSIONS	It has potential for use with persons unable to self-report anxiety .
-CONCLUSIONS	Further validation is recommended , but its continuing use is supported .
-
-###24758417
-OBJECTIVE	Ginseng root and its derivatives remain atop the most widely used medicinal herbs in cardiovascular disease , despite inadequate substantiation of efficacy .
-OBJECTIVE	We previously reported the potential of Korean red ginseng ( KRG ) to affect vascular tone by decreasing arterial wave reflection via an unknown mechanism .
-OBJECTIVE	Given the preclinical link between ginseng intake and vasoactivity related to nitric oxide ( NO ) production , we sought to directly evaluate the effects of KRG root and its major root components , on an established noninvasive measure of endothelial function .
-METHODS	In an acute , randomized , placebo-controlled , double-blind , crossover design , 16 healthy participants ( 9M :7 F , age :309 y , BMI : 24 kg3kg/m ( 2 ) , systolicBP/diastolicBP : 10911/668mmHg ) on four occasions were administered : KRG root ( 3g ) , KRG ginsenosides extract , KRG polysaccharides extract , and cornstarch control .
-METHODS	Extracted fractions were delivered at doses bioequivalent to those found in 3g of KRG .
-METHODS	Flow-mediated vasodilatation ( FMD ) assessment , preceding a brachial blood pressure measurement , was performed at baseline and at 90 and 180 min posttreatment to assess endothelial function .
-RESULTS	KRG significantly improved FMD posttreatment .
-RESULTS	Maximal vasodilatation of 2.572.8 % occurred at 180min compared with control ( -0.832.7 % , P = 0.003 for all comparisons ) .
-RESULTS	The ginsenoside extract produced a comparable response ( 1.752.6 % ) , but not the polysaccharide fraction ( 0.102.7 % ) .
-RESULTS	Brachial blood pressure remained unchanged for all treatments ( P = 0.45 ) .
-CONCLUSIONS	KRG acutely improved endothelial function in healthy individuals , which appears to be attributable to its ginsenoside containing fraction .
-CONCLUSIONS	Our data confirm preclinical data and support the potential for these compounds as targets for therapeutic strategies in disorders involving endothelial dysfunction .
-
-###25012707
-OBJECTIVE	The Micropuncture 21-gauge needle may reduce complications related to vessel trauma from inadvertent venous or posterior arterial wall puncture .
-METHODS	This was a single-center , multiple-user trial .
-METHODS	Four hundred and two patients undergoing possible or definite percutaneous coronary intervention ( PCI ) were randomized 1:1 to an 18-gauge versus a 21-gauge needle .
-METHODS	Patients and personnel pulling the sheaths and performing the follow-up were blinded .
-METHODS	The primary end point was a composite of access bleeding .
-METHODS	Events were tabulated following sheath removal , 24 h after the procedure and at the follow-up ( at 1-2 weeks ) .
-METHODS	End points were blindly adjudicated .
-RESULTS	The event rate overall was 12.4 % and did not differ significantly between groups , although the 21-gauge needle was found to reduce events by more than one third .
-RESULTS	An exploratory subgroup analysis of prespecified variables indicated that : patients who did not undergo PCI or elective procedures , female patients and those with a final sheath size of 6 Fr all had a significant or near-significant reduction of complications with Micropuncture .
-CONCLUSIONS	Although no significant differences between the use of the 18 - and 21-gauge needles were observed , there was a 50-75 % reduction with Micropuncture in several subgroups .
-CONCLUSIONS	The study was terminated prematurely .
-CONCLUSIONS	Access site complications may be reduced by the use of the 21-gauge needle , particularly when the risk of bleeding is not high .
-CONCLUSIONS	Further multicenter data will be required to confirm these hypothesis-generating observations .
-
-###24827405
-BACKGROUND	No randomized comparative trials have presented long-term outcomes for laparoscopic sleeve gastrectomy ( LSG ) and laparoscopic Roux-en-Y gastric bypass ( LRYGB ) .
-BACKGROUND	The present study was designed to compare the efficacy and safety of these two procedures .
-METHODS	From January 2007 to July 2008 , 64 eligible patients were randomly assigned to LSG or LRYGB .
-METHODS	During the 5-year follow-up , we compared morbidity rate , body mass index ( BMI ) , percent of excess weight loss ( % EWL ) , Moorehead-Ardelt ( M-A ) II quality of life , and resolution or improvement rate of obesity-related comorbidities between the groups .
-RESULTS	Both groups were matched with respect to age , gender , and BMI .
-RESULTS	Slightly more major complications were observed in patients undergoing LRYGB ( P > 0.05 ) .
-RESULTS	Weight loss was significantly better with LRYGB except during the first postoperative year .
-RESULTS	At 5 years , % EWL for LSG and LRYGB was 63.224.5 % and 76.221.7 % ( P = 0.02 ) , respectively .
-RESULTS	No statistical difference was observed in quality of life between the groups at all intervals ( P > 0.05 ) .
-RESULTS	At the last follow-up , most comorbidities in both groups were resolved or improved , with no difference between the groups ( P > 0.05 ) .
-CONCLUSIONS	LRYGB and LSG are equally safe and effective in quality of life and improvement or resolution of comorbidities , and LRYGB possesses the superiority in terms of weight loss .
-CONCLUSIONS	Further studies are needed to evaluate micronutrient deficiencies of these procedures .
-
-###24676435
-OBJECTIVE	To assess the effect of aerobic exercise on the cognition and functional capacity in Alzheimer 's disease ( AD ) patients .
-METHODS	Elderly ( n = 20 ) with mild dementia ( NINCDS-ADRDA/CDR1 ) were randomly assigned to an exercise group ( EG ) on a treadmill ( 30 minutes , twice a week and moderate intensity of 60 % VOmax ) and control group ( GC ) 10 patients .
-METHODS	The primary outcome measure was the cognitive function using Cambridge Cognitive Examination ( CAMCOG ) .
-METHODS	Specifics instruments were also applied to evaluate executive function , memory , attention and concentration , cognitive flexibility , inhibitory control and functional capacity .
-RESULTS	After 16 weeks , the EG showed improvement in cognition CAMCOG whereas the CG declined .
-RESULTS	Compared to the CG , the EG presented significant improvement on the functional capacity .
-RESULTS	The analysis of the effect size has shown a favorable response to the physical exercise in all dependent variables .
-CONCLUSIONS	Walking on treadmill may be recommended as an augmentation treatment for patients with AD .
-
-###24524600
-OBJECTIVE	To evaluate the effects and clinical prognosis of out-patient department-based smoking cessation services for coronary heart disease ( CHD ) patients .
-METHODS	A total of 140 smoking patients diagnosed with coronary heart disease in our cardiovascular department were randomly divided into the intensive smoking cessation clinic follow-up group ( intervention group , patients were informed on the importance and methods to quit smoking at the first visit and reminded for that at months interval for 6 months , n = 70 ) and the conventional treatment group ( control group , n = 70 ) .
-METHODS	After 6 months , the smoking status , cardiovascular event rates , drug usage , out-patient medical costs and quality of life were compared between the two groups .
-RESULTS	Age , gender , concomitant diseases , drug usage were similar between the two groups at baseline ( all P > 0.05 ) .
-RESULTS	After 6 months , smoking quit rate [ 34.2 % ( 24/70 ) vs. 5.7 % ( 4/70 ) , P < 0.01 ] , drug use rates : lipid-lowering drugs [ 95.3 % ( 67/70 ) vs. 80.4 % ( 56/70 ) ] , blockers [ 82.4 % ( 57/70 ) vs. 41.3 % ( 28/70 ) ] , and ACEI/ARB [ 61.4 % ( 43/70 ) vs. 34.4 % ( 24/70 ) ] were significantly higher in the intervention group than in the control group , while total cardiovascular event rates [ 21.4 % ( 15/70 ) vs. 47.1 % ( 33/70 ) , P < 0.01 ] and out-patient medical costs ( 3789.3 RMB vs. 4984.2 RMB , P < 0.01 ) were significantly lower in the intervention group than in the control group .
-RESULTS	The quality of life scores derived from MYO health survey questionnaire was significantly higher in the intervention group than in the control group ( P < 0.01 ) .
-RESULTS	The top three reasons responsible for continuous smoking for all patients failed to quit smoking were : ( 1 ) others smoked more than me and still alive and healthy [ 90.3 % ( 56/62 ) ] ; ( 2 ) smoking helped me to keep relaxed and reduce trouble in daily work and life [ 70.9 % ( 44/62 ) ] ; ( 3 ) smoking was essential while chatting and drinking with friends [ 66.1 % ( 41/62 ) ] .
-RESULTS	The overall satisfactory rate to this smoking cessation program was 42.8 % and the satisfactory rate was up to 50.0 % by patients .
-CONCLUSIONS	Intensive outpatient smoking cessation follow-up program can significantly improve the smoking cessation rates , the guideline drug use rate and the quality of life while reduce medical costs for coronary heart disease patients .
-
-###24439596
-BACKGROUND	We conducted a prospective , randomized trial comparing protocol to ad libitum ( ad lib ) feeding after laparoscopic pyloromyotomy .
-METHODS	Infants undergoing laparoscopic pyloromyotomy were randomized to protocol versus ad lib feeding strategies .
-METHODS	The protocol started with Pedialyte two hours post-operative .
-METHODS	This was repeated by another round of Pedialyte , then two rounds of half-strength formula or breast milk , followed by two rounds of full strength formula or breast milk , followed by the home feeding regimen , at which time the patient was discharged if feeding well .
-METHODS	The ad lib group was allowed formula or breast milk two hours after the operation and considered for discharge after tolerating three consecutive feeds .
-METHODS	The primary outcome variable was the length of postoperative hospitalization .
-RESULTS	One hundred fifty infants were enrolled between January 2010 and December 2011 .
-RESULTS	There were no differences in patient characteristics at presentation .
-RESULTS	While the ad lib group reached goal feeds sooner than the protocol group , this did not translate into a difference in duration of postoperative hospitalization .
-RESULTS	There were more patients with emesis in the ad lib group after goal feeding was reached , but no difference in readmissions .
-CONCLUSIONS	Ad lib feeding allows patients to reach goal feeds more rapidly than protocol feeding following laparoscopic pyloromyotomy .
-CONCLUSIONS	However , this goal is usually reached beyond discharge hours , resulting in a similar duration of hospitalization .
-
-###25761587
-OBJECTIVE	To evaluate the efficacy of dienogest + estradiol valerate ( E2V ) and gonadotrophin-releasing hormone analogue ( GnRH-a ) in reducing recurrence of pain in patients with chronic pelvic pain due to laparoscopically diagnosed and treated endometriosis .
-METHODS	Multi-center , prospective , randomized study .
-METHODS	Three university departments of obstetrics and gynecology in Italy .
-METHODS	Seventy-eight women who underwent laparoscopic surgery for endometriosis combined with chronic pelvic pain .
-METHODS	Post-operative administration of dienogest + E2V for 9 months ( group 1 ) or GnRH-a monthly for 6 months ( group 2 ) .
-METHODS	A visual analogue scale was used to test intensity of pain before laparoscopic surgery at 3 , 6 and 9 months of follow up .
-METHODS	A questionnaire to investigate quality of life was administered before surgery and at 9 months of follow up .
-RESULTS	The visual analogue scale score did not show any significant differences between the two groups ( p = 0.417 ) .
-RESULTS	The questionnaire showed an increase of scores for all women compared with pre-surgery values , demonstrating a marked improvement in quality of life and health-related satisfaction with both treatments .
-RESULTS	No significant differences were found between the groups .
-RESULTS	The rate of apparent endometriosis recurrence was 10.8 % in group 1 and 13.7 % in group 2 ( p = 0.962 ) .
-CONCLUSIONS	Both therapies seemed equally efficacious in preventing endometriosis-related chronic pelvic pain recurrence in the first 9 months of follow-up .
-
-###25084967
-BACKGROUND	The in utero environment is known to affect fetal development however many of the mechanisms by which this occurs remain unknown .
-BACKGROUND	The aim of this study was to examine the association between maternal dietary macronutrient intake and lifestyle throughout pregnancy and neonatal weight and adiposity .
-METHODS	This was an analysis of 542 mother and infant pairs from the ROLO study ( Randomised cOntrol trial of LOw glycaemic index diet versus no dietary intervention to prevent recurrence of fetal macrosomia ) .
-METHODS	Food diaries as well as food frequency and lifestyle and physical activity questionnaires were completed during pregnancy .
-METHODS	Maternal anthropometry was measured throughout pregnancy and neonatal anthropometry was measured at birth .
-RESULTS	Multiple linear regression analysis revealed the main maternal factor associated with increased birth weight was greater gestational weight gain R2adj 23.3 % ( F = 11.547 , p < 0.001 ) .
-RESULTS	The main maternal factor associated with increased birth length was non-smoking status R2adj 27.8 % ( F = 6.193 , p < 0.001 ) .
-RESULTS	Neonatal central adiposity ( determined using waist : length ratio ) was negatively associated with maternal age , and positively associated with the following parameters : smoking status , maternal pre-pregnancy arm circumference , percentage energy from saturated fat in late pregnancy , postprandial glucose at 28 weeks gestation and membership of the control group with a positive trend towards association with trimester 2 glycaemic load R2adj 38.1 % ( F = 8.000 , p < 0.001 ) .
-CONCLUSIONS	Several maternal diet and lifestyle factors were associated with neonatal anthropometry .
-CONCLUSIONS	Low glycaemic index dietary intervention in pregnancy was found to have a beneficial effect on neonatal central adiposity .
-CONCLUSIONS	Additionally , central adiposity was positively associated with maternal dietary fat intake and postprandial glucose highlighting the important role of healthy diet in pregnancy in promoting normal neonatal adiposity .
-BACKGROUND	Current Controlled Trials ISRCTN54392969 .
-
-###24737786
-OBJECTIVE	To estimate the incremental cost-effectiveness of infliximab versus conventional combination treatment over 21months in patients with methotrexate-refractory early rheumatoid arthritis .
-METHODS	In this multicentre , two-arm , parallel , randomised , active-controlled , open-label trial , rheumatoid arthritis patients with < 1year symptom duration were recruited from 15 rheumatology clinics in Sweden between October 2002 and December 2005 .
-METHODS	After 3-4months of methotrexate monotherapy , patients not achieving low disease activity were randomised to addition of infliximab or sulfasalazine + hydroxychloroquine ( conventional treatment group ) .
-METHODS	Costs of drugs , healthcare use , and productivity losses were retrieved from nationwide registers , while EuroQol 5-Dimensions utility was collected quarterly .
-RESULTS	Of 487 patients initially enrolled , 128 and 130 were randomised to infliximab and conventional treatment , respectively .
-RESULTS	The infliximab group accumulated higher drug and healthcare costs ( 27,487 vs 10,364 ; adjusted mean difference 16,956 ( 95 % CI 14,647 to 19,162 ) ) , while productivity losses did not differ ( 33,804 vs 29,220 ; 3961 ( 95 % CI -3986 to 11,850 ) ) , resulting in higher societal cost compared to the conventional group ( 61,291 vs 39,584 ; 20,916 ( 95 % CI 12,800 to 28,660 ) ) .
-RESULTS	Mean accumulated quality-adjusted life-years ( QALYs ) did not differ ( 1.10 vs 1.12 ; adjusted mean difference favouring infliximab treatment 0.01 ( 95 % CI -0.07 to 0.08 ) ) .
-RESULTS	The incremental cost-effectiveness ratios for the infliximab versus conventional treatment strategy were 2,404,197 / QALY from the societal perspective and 1,948,919 / QALY from the healthcare perspective .
-CONCLUSIONS	In early , methotrexate-refractory rheumatoid arthritis , a treatment strategy commencing with addition of infliximab , as compared to sulfasalazine + hydroxychloroquine , was not cost-effective over 21months at willingness to pay levels generally considered acceptable .
-BACKGROUND	NCT00764725 .
-
-###24655054
-OBJECTIVE	To identify growth-related collagen and bone parameters in small-for-gestational-age ( SGA ) and appropriate-for-gestational-age ( AGA ) preterm infants during the first six months post-term .
-OBJECTIVE	In SGA preterm infants , increased growth and decreased bone acquisition , which we demonstrated previously , may be reflected by these markers .
-METHODS	Observational study within a randomized controlled trial .
-METHODS	Thirty-three SGA ( weight , length or both at birth < -2 SDS ) and 98 AGA preterm infants ( gestational age [ median ( IQR ) ] : 311 ( 16 ) vs 303 ( 20 ) weeks ; 727 % vs 429 % boys ) .
-METHODS	Weight ( g ) , length ( cm ) , procollagen type I N-terminal peptide ( PINP ; g/l ) , urinary helical peptide ( UHP ; g/mmol creatinine ) and alkaline phosphatase ( ALP ; U/l ) expressed as standard deviation scores ( SDS ) at term age , three and six months post-term .
-RESULTS	Weight and length gain during the first six months post-term and PINP SDS at term age , three months and six months post-term were higher in SGA compared with AGA infants .
-RESULTS	UHP SDS and ALP SDS were similar in SGA and AGA infants .
-RESULTS	PINP SDS and UHP SDS at term age and PINP SDS at three months were associated with subsequent weight and length gain until six months post-term .
-CONCLUSIONS	Increased growth in SGA compared with AGA preterm infants is reflected by increased collagen type I synthesis during the first six months post-term , suggesting that PINP and UHP correspond with growth in preterm infants .
-CONCLUSIONS	An explanation for decreased bone acquisition of SGA preterm infants may be that increased collagen type I synthesis is not directly followed by increased bone mineralization .
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-###25758273
-BACKGROUND	Current randomized trials have demonstrated the effects of short-term rosuvastatin therapy in preventing contrast-induced acute kidney injury ( CIAKI ) .
-BACKGROUND	However , the consistency of these effects on patients administered different volumes of contrast media is unknown .
-METHODS	In the TRACK-D trial , 2998 patients with type 2 diabetes and concomitant chronic kidney disease ( CKD ) who underwent coronary/peripheral arterial angiography with or without percutaneous intervention were randomized to short-term ( 2 days before and 3 days after procedure ) rosuvastatin therapy or standard-of-care .
-METHODS	This prespecified analysis compared the effects of rosuvastatin versus standard therapy in patients exposed to ( moderate contrast volume [ MCV ] , 200-300 ml , n = 712 ) or ( high contrast volume [ HCV ] , 300 ml , n = 220 ) .
-METHODS	The primary outcome was the incidence of CIAKI .
-METHODS	The secondary outcome was a composite of death , dialysis/hemofiltration or worsened heart failure at 30 days .
-RESULTS	Rosuvastatin treatment was associated with a significant reduction in CIAKI compared with the controls ( 2.1 % vs. 4.4 % , P = 0.050 ) in the overall cohort and in patients with MCV ( 1.7 % vs. 4.5 % , P = 0.029 ) , whereas no benefit was observed in patients with HCV ( 3.4 % vs. 3.9 % , P = 0.834 ) .
-RESULTS	The incidence of secondary outcomes was significantly lower in the rosuvastatin group compared with control group ( 2.7 % vs. 5.3 % , P = 0.049 ) in the overall cohort , but it was similar between the patients with MCV ( 2.0 % vs. 4.2 % , P = 0.081 ) or HCV ( 5.1 % vs. 8.8 % , P = 0.273 ) .
-CONCLUSIONS	Periprocedural short-term rosuvastatin treatment is effective in reducing CIAKI and adverse clinical events for patients with diabetes and CKD after their exposure to a moderate volume of contrast medium .
-
-###25341356
-OBJECTIVE	To investgate the effect of Xuebijing Injection on immune regulation in patients with systemic inflammatory response syndrome ( SIRS ) .
-METHODS	56 SIRS patients admitted to the ICU of Guizhou Provincial Hospital from January 2013 to December 2013 were included in this study .
-METHODS	The patients were randomly divided into a control ( C ) and a treatment ( T ) group .
-METHODS	Patients in C group received routine treatment ; while patients in T group received additional Xuebijing Injection 50 mL Bid .
-METHODS	The following indicators were recorded and compared between the two groups before and 4 and 7 days after treatments : CD4 + , CD8 + , CD4 + / CD8 + , monocytes CD14 + / human leukocyte antigen-DR ( HLA-DR ) , score of acute physiology and chronic health evaluation II ( APACHE II ) , heart rate , white blood cells , body temperature , respiration rate , and MODS ( 7 d after treatment only ) .
-RESULTS	No differences were found between the two groups before treatments ( P > 0.05 ) .
-RESULTS	T Group had higher levels of CD4 + , CD8 , CD4 + / CD8 + and monocytes CD14 + / HLA-DR than C group at 4 and 7 d after treatments ( P < 0.05 ) .
-RESULTS	T group also had higher levels of improvement in vital indicators compared with C group ( P < 0.05 ) .
-RESULTS	No significant difference in incidence of multiple organ dysfunction syndrome ( MODS ) was found between the two groups ( P > 0.05 ) .
-CONCLUSIONS	Xuebijing Injection can regulate immune function of patients with SIRS .
-
-###24357423
-BACKGROUND	Incisional hernias in old stoma wounds occur in one-third of former stoma patients and pose a significant clinical problem .
-BACKGROUND	Parastomal hernias can be prevented by prophylactic mesh placement ; however , no trial results are available for incisional hernia prevention after stoma reversal .
-BACKGROUND	In this feasibility study , we explore the safety of placing an intraperitoneal mesh to prevent incisional herniation after temporary stoma reversal .
-METHODS	Ten patients who underwent a low anterior resection with a deviating double-loop stoma for rectal cancer received an intraperitoneal parastomal mesh at the time of stoma formation .
-METHODS	At stoma reversal , laparoscopy was performed and adhesions were scored .
-METHODS	After reversal , the mesh defect was closed .
-METHODS	Mesh and stoma complications were closely monitored .
-METHODS	Incisional herniation was assessed at the 2-year follow-up after stoma reversal using ultrasonography .
-RESULTS	No infections occurred after mesh placement .
-RESULTS	After a median of 6 months , stomas were reversed .
-RESULTS	Laparoscopy could be performed in seven patients ; all patients had adhesions ( median of 25 % of mesh surface ) .
-RESULTS	In three patients , the bowel was involved ; one required a laparotomy for bowel mobilization during stoma reversal .
-RESULTS	No adhesion-related morbidity was noted at any time .
-RESULTS	Except for one superficial wound infection after stoma reversal , no infectious complications were observed .
-RESULTS	After a median follow-up of 26 months , no incisional herniations were demonstrated .
-CONCLUSIONS	Prophylactic mesh placement in temporary stoma formations seems safe and feasible and prevents incisional herniation 2 years after stoma reversal .
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-###25596659
-BACKGROUND	We aimed to compare panitumumab , a fully human monoclonal antibody against EGFR , plus radiotherapy with chemoradiotherapy in patients with unresected , locally advanced squamous-cell carcinoma of the head and neck .
-METHODS	In this international , open-label , randomised , controlled , phase 2 trial , we recruited patients with locally advanced squamous-cell carcinoma of the head and neck from 22 sites in eight countries worldwide .
-METHODS	Patients aged 18 years and older with stage III , IVa , or IVb , previously untreated , measurable ( 10 mm for at least one dimension ) , locally advanced squamous-cell carcinoma of the head and neck ( non-nasopharygeal ) and an Eastern Cooperative Oncology Group performance status of 0-1 were randomly assigned ( 2:3 ) by an independent vendor to open-label chemoradiotherapy ( two cycles of cisplatin 100 mg/m ( 2 ) during radiotherapy ) or to radiotherapy plus panitumumab ( three cycles of panitumumab 9 mg/kg every 3 weeks administered with radiotherapy ) using a stratified randomisation with a block size of five .
-METHODS	All patients received 70-72 Gy to gross tumour and 54 Gy to areas of subclinical disease with accelerated fractionation radiotherapy .
-METHODS	The primary endpoint was local-regional control at 2 years , analysed in all randomly assigned patients who received at least one dose of their assigned protocol-specific treatment ( chemotherapy , radiation , or panitumumab ) .
-METHODS	The trial is closed and this is the final analysis .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT00547157 .
-RESULTS	Between Nov 30 , 2007 , and Nov 16 , 2009 , 152 patients were enrolled , and 151 received treatment ( 61 in the chemoradiotherapy group and 90 in the radiotherapy plus panitumumab group ) .
-RESULTS	Local-regional control at 2 years was 61 % ( 95 % CI 47-72 ) in the chemoradiotherapy group and 51 % ( 40-62 ) in the radiotherapy plus panitumumab group .
-RESULTS	The most frequent grade 3-4 adverse events were mucosal inflammation ( 25 [ 40 % ] of 62 patients in the chemoradiotherapy group vs 37 [ 42 % ] of 89 patients in the radiotherapy plus panitumumab group ) , dysphagia ( 20 [ 32 % ] vs 36 [ 40 % ] ) , and radiation skin injury ( seven [ 11 % ] vs 21 [ 24 % ] ) .
-RESULTS	Serious adverse events were reported in 25 ( 40 % ) of 62 patients in the chemoradiotherapy group and in 30 ( 34 % ) of 89 patients in the radiotherapy plus panitumumab group .
-CONCLUSIONS	Panitumumab can not replace cisplatin in the combined treatment with radiotherapy for unresected stage III-IVb squamous-cell carcinoma of the head and neck , and the role of EGFR inhibition in locally advanced squamous-cell carcinoma of the head and neck needs to be reassessed .
-BACKGROUND	Amgen .
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-###24852468
-BACKGROUND	High-intensity focused ultrasound ( HIFU ) is a noninvasive alternative to traditional invasive body sculpting procedures .
-OBJECTIVE	To assess the effectiveness and tolerability of HIFU treatment using high and low fluence settings with 2 treatment techniques , grid repeat ( GR ) and site repeat ( SR ) .
-METHODS	Two multicenter studies were conducted .
-METHODS	Subjects underwent 1 HIFU treatment with 1 of 5 treatment protocols ( total fluence , 150-180 J/cm ) .
-METHODS	Primary end point was change from baseline in waist circumference ( CBWC ) at 12 weeks .
-METHODS	Secondary end points included CBWC at 4 and 8 weeks and investigator - and subject-assessed clinical improvement .
-METHODS	Adverse events were monitored throughout the study .
-RESULTS	In the intent-to-treat ( ITT ) population , all subjects had a statistically significant mean circumferential reduction of -2.3 2.9 cm ( p < .0001 ) from baseline at 12 weeks , with no significant differences among the 5 treatment groups ( ITT : p = .153 ) .
-RESULTS	Analysis of secondary end points in the ITT population demonstrated a significant circumferential reduction starting as early as 4 weeks in all subjects ( -1.1 1.9 cm , p < .0001 ) .
-RESULTS	Most subjects in all treatment groups showed improvements at 12 weeks as rated by the investigators and subjects .
-CONCLUSIONS	High-intensity focused ultrasound treatment using either a low or high fluence setting in a GR or SR method is effective for circumferential waist reduction , resulting in statistically significant CBWC in all treatment groups .
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-###25797757
-BACKGROUND	Postoperative readmissions have been proposed by Medicare as a quality metric and can impact provider reimbursement .
-BACKGROUND	Because readmission after pancreatectomy is common , we sought to identify factors associated with readmission to establish a predictive risk scoring system .
-METHODS	A retrospective analysis of 2,360 pancreatectomies performed at 9 high-volume pancreatic centers between 2005 and 2011 was performed .
-METHODS	Forty-five factors strongly associated with readmission were identified .
-METHODS	To derive and validate a risk scoring system , the population was randomly divided into 2 cohorts in a 4:1 fashion .
-METHODS	A multivariable logistic regression model was constructed and scores were assigned based on the relative odds ratio ( OR ) of each independent predictor .
-METHODS	A composite Readmission after Pancreatectomy ( RAP ) score was generated and then stratified to create risk groups .
-RESULTS	Overall , 464 ( 19.7 % ) patients were readmitted within 90 days .
-RESULTS	Eight pre - and postoperative factors , including earlier MI ( OR = 2.03 ) , American Society of Anesthesiologists class 3 ( OR = 1.34 ) , dementia ( OR = 6.22 ) , hemorrhage ( OR = 1.81 ) , delayed gastric emptying ( OR = 1.78 ) , surgical site infection ( OR = 3.31 ) , sepsis ( OR = 3.10 ) , and short length of stay ( OR = 1.51 ) were independently predictive of readmission .
-RESULTS	The 32-point RAP score generated from the derivation cohort was highly predictive of readmission in the validation cohort ( area under the receiver operating curve = 0.72 ) .
-RESULTS	The low-risk ( 0 to 3 ) , intermediate-risk ( 4 to 7 ) , and high-risk ( > 7 ) groups correlated with 11.7 % , 17.5 % , and 45.4 % observed readmission rates , respectively ( p < 0.001 ) .
-CONCLUSIONS	The RAP score is a novel and clinically useful risk scoring system for readmission after pancreatectomy .
-CONCLUSIONS	Identification of patients with increased risk of readmission using the RAP score will allow efficient resource allocation aimed to attenuate readmission rates .
-CONCLUSIONS	It also has potential to serve as a new metric for comparative research and quality assessment .
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-###24314158
-OBJECTIVE	To compare the induction of remission and cost-effectiveness of enteral nutrition ( EN ) and infliximab ( IFX ) in moderate-to-severe active Crohn 's disease ( CD ) .
-METHODS	Moderate-to-severe active CD patients were divided into IFX group and EN group .
-METHODS	Remission rate , time to remission and treatment cost were compared between the two groups .
-METHODS	Clinical remission was defined as Crohn 's disease activity index ( CDAI ) < 150 .
-METHODS	The quality of life was evaluated by inflammatory bowel disease questionnaire of quality of life ( IBDQ ) .
-RESULTS	A total of 100 patients were analyzed , including 48 patients in IFX group and 52 patients in EN group .
-RESULTS	IFX group had higher remission rate [ 87.5 % ( 42/48 ) vs 67.3 % ( 35/52 ) , P = 0.017 ] and shorter time to remission [ ( 11.00 8.35 ) days vs ( 33.94 14.60 ) days , P < 0.001 ] than EN group .
-RESULTS	Treatment costs before remission were similar in two groups ( P = 0.351 ) .
-RESULTS	The increase of IBDQ scores before and after treatment in IFX group was much higher than that of EN group ( 42.74 27.50 vs 7.57 22.77 , P < 0.001 ) .
-RESULTS	Similarly , patients in EN group had greater increase of body mass index ( BMI ) than that of IFX group [ ( 1.32 0.29 ) kg/m ( 2 ) vs ( 0.51 0.07 ) kg/m ( 2 ) , P < 0.001 ] .
-RESULTS	For patients with CDAI < 280 , remission rate was not significantly different [ 85.7 % ( 24/28 ) vs 81.8 % ( 18/22 ) , P = 0.718 ] between the two groups , while treatment cost in EN group was less than that of IFX group [ ( 16.1 5.9 ) 10 ( 3 ) RMB vs ( 22.9 11.9 ) 10 ( 3 ) RMB , P = 0.021 ] .
-CONCLUSIONS	For patients with severe CD ( CDAI 280 ) , IFX has higher remission rate , shorter time to remission and comparable treatment cost than EN .
-CONCLUSIONS	But for patients with CDAI < 280 , EN group has comparable remission rate to IFX group with lower cost .
-
-###25050898
-BACKGROUND	Testicular germ cell cancer ( GCC ) patients treated with cisplatin-etoposide-bleomycin chemotherapy ( BEP ) have excellent prognosis but have an increased risk of late-occurring morbidities , which may be associated with changes in the inflammatory profile .
-OBJECTIVE	The objective of the study was to explore plasma cytokine concentrations in GCC patients randomized to resistance training or usual care during BEP , in comparison with healthy controls .
-METHODS	This was a randomized controlled trial in GCC patients enrolled from an oncology clinic , including a healthy reference group for comparison purposes .
-METHODS	Plasma granulocyte macrophage colony-stimulating factor , interferon - , IL-1 , IL-2 , IL-6 , IL-8 , IL-10 , IL-12 , and TNF - were measured in fasting blood samples from GCC patients randomized to resistance training ( INT ; n = 15 ) or usual care ( CON ; n = 15 ) and healthy age-matched controls ( REF ; n = 19 ) .
-METHODS	Clinical toxicity assessments and patient-reported end points were also recorded .
-RESULTS	CON and INT were balanced at baseline .
-RESULTS	Compared with REF , CON had higher concentrations of IL-10 , IL-6 , and interferon - , and INT had higher concentrations of IL-6 , IL-8 and TNF - ( all P < .05 ) .
-RESULTS	At the end of therapy , concentrations of IL-6 , IL-8 , and IL-10 increased in both GCC groups ( all P < .01 ) .
-RESULTS	Three months after therapy , all cytokine concentrations were comparable with the pretreatment levels in both GCC-groups but remained elevated compared with REF ( P < .05 ) .
-RESULTS	Changes in TNF - correlated with pulmonary toxicity ( P < .01 ) .
-RESULTS	At the end of therapy , IL-6 concentrations correlated with quality of life ( P < .05 ) and fatigue ( P < .01 ) .
-CONCLUSIONS	GCC patients treated with BEP display consistently elevated levels of systemic inflammatory markers compared with healthy controls .
-CONCLUSIONS	Resistance training during therapy has no impact on plasma cytokine concentrations .
-
-###25295437
-OBJECTIVE	This work tested the hypothesis that patients with high negative affectivity ( NA ) would have a better response to a serotonergic agent ( escitalopram ) than to one not thought to act directly on serotonin ( bupropion ) .
-METHODS	Data from a study conducted between August 2007 and July 2011 were reanalyzed retrospectively .
-METHODS	Patients ( N = 245 ) meeting criteria for major depressive disorder ( MDD ) , diagnosed with DSM-IV-TR , were randomly assigned to double-blind treatment with bupropion extended-release , escitalopram , or the combination .
-METHODS	Negative affectivity score was estimated using the guilt , hostility/irritability , and fear/anxiety items of the Hamilton Depression Rating Scale , the Montgomery-Asberg Depression Rating Scale , the Quick Inventory of Depressive Symptoms , and the Social Adjustment Scale .
-METHODS	We felt that these items captured published descriptions of the NA construct .
-METHODS	A Clinical Global Impressions-Severity of Illness ( CGI-S ) score 2 defined response .
-METHODS	Because combined treatment addressed both serotonin and non-serotonin systems , patients treated with both medications did not test the hypothesis and so were excluded from the analyses .
-RESULTS	Analysis of covariance with treatment as a grouping variable , NA as covariate , and CGI-S as dependent variable showed a significant 2-way interaction between treatment and NA ( F , = 4.82 , P < .03 ) .
-RESULTS	In the low-NA group , response rates were similar between treatments ( escitalopram : 28/42 [ 67 % ] ; bupropion : 23/40 [ 58 % ] ; NS ) , while there was a significant advantage for escitalopram in patients with high NA ( escitalopram : 24/40 [ 60 % ] ; bupropion = 14/41 [ 34 % ] ; P = .017 ) .
-CONCLUSIONS	These data suggest that patients with high negative affectivity respond preferentially to antidepressants that selectively enhance serotonin neurotransmission .
-CONCLUSIONS	Although patients with low NA appear to benefit from serotonin enhancement as well , they also improved with bupropion , an antidepressant not thought to directly affect serotonin neurotransmission .
-CONCLUSIONS	These findings come from retrospective analyses using unproven approximation of NA , so no clinical inferences should be made before independent replication utilizing accepted NA measurement .
-BACKGROUND	ClinicalTrials.gov identifier : NCT00519428 .
-
-###25415108
-BACKGROUND	There is no consensus on the efficacy of postoperative infusion of local anesthetics after radical mastectomy .
-METHODS	A randomized , double-blind , placebo-controlled , parallel-groups clinical trial was conducted in a tertiary hospital .
-METHODS	Eighty consecutive women with operable breast cancer with indications for modified radical mastectomy without breast reconstruction were assigned randomly to receive infusion of levobupivacaine ( 0.5 % ) or saline at 2 ml/hour for 48 hours through a wound catheter .
-METHODS	Seventy-three women finished the study ( intervention group , n = 34 ; control group , n = 39 ) .
-METHODS	During surgery , all patients received 0.25 % levobupivacaine ( 30 ml ) .
-RESULTS	The levobupivacaine group reported less pain ( p < 0.001 ) than controls in the postanesthesia care unit ( 1.6 1.3 versus 6.7 1.8 ) and on the ward at 24 ( 0.8 0.9 versus 4.2 1.9 ) and 48 ( 0.4 0.7 versus 3.3 2.3 ) hours .
-RESULTS	In the postanesthesia care unit , the levobupivacaine group consumed less metamizole ( 0.4 0.5 versus 0.8 0.4 ; p < 0.001 ) and dexketoprofen ( 0.1 0.3 versus 0.7 0.4 ; p < 0.001 ) , with differences in paracetamol use being insignificant ( 0.8 0.4 versus 0.9 0.3 ; p = 0.140 ) .
-RESULTS	On the ward , the levobupivacaine group used significantly less paracetamol ( 0.5 0.7 versus 2.0 2.0 ; p < 0.001 ) and metamizole ( 0.2 0.4 versus 1.2 1.4 ; p < 0.001 ) , but differences in dexketoprofen were not significant ( 0.03 0.2 versus 0.2 0.6 ; p = 0.074 ) .
-RESULTS	In the postanesthesia care unit , the levobupivacaine and control groups consumed 0 0 and 0.7 1.2 doses of opioids ( p = 0.001 ) , respectively .
-RESULTS	The authors observed no differences in nausea and vomiting at any stage in the postanesthesia care unit ( 0.2 0.4 versus 0.4 0.5 ; p = 0.081 ) or on the ward ( 0.3 0.5 versus 0.4 0.5 ; p = 0.563 ) .
-RESULTS	All participants reported high levels of satisfaction .
-CONCLUSIONS	Continuous infusion of local anesthetic reduces pain and analgesic consumption , with high satisfaction , but does not affect rates of nausea and vomiting .
-
-###24876261
-OBJECTIVE	The Interventional Management of Stroke ( IMS ) III study tested the effect of intravenous tissue-type plasminogen activator ( tPA ) alone when compared with intravenous tPA followed by endovascular therapy and collected cost data to assess the economic implications of the 2 therapies .
-OBJECTIVE	This report describes the factors affecting the costs of the initial hospitalization for acute stroke subjects from the United States .
-METHODS	Prospective cost analysis of the US subjects was treated with intravenous tPA alone or with intravenous tPA followed by endovascular therapy in the IMS III trial .
-METHODS	Results were compared with expected Medicare payments .
-RESULTS	The adjusted cost of a stroke admission in the study was $ 35 130 for subjects treated with endovascular therapy after intravenous tPA treatment and $ 25 630 for subjects treated with intravenous tPA alone ( P < 0.0001 ) .
-RESULTS	Significant factors related to costs included treatment group , baseline National Institutes of Health Stroke Scale , time from stroke onset to intravenous tPA , age , stroke location , and comorbid diabetes mellitus .
-RESULTS	The mean cost for subjects who had routine use of general anesthesia as part of endovascular therapy was $ 46 444 when compared with $ 30 350 for those who did not have general anesthesia .
-RESULTS	The costs of embolectomy for IMS III subjects and patients from the National Inpatient Sample cohort exceeded the Medicare diagnosis-related group payment in 75 % of patients .
-CONCLUSIONS	Minimizing the time to start of intravenous tPA and decreasing the use of routine general anesthesia may improve the cost-effectiveness of medical and endovascular therapy for acute stroke .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00359424 .
-
-###24675168
-BACKGROUND	Dietary linoleic acid ( LA , 18:2 n-6 ) lowering in rats reduces n-6 polyunsaturated fatty acid ( PUFA ) plasma concentrations and increases n-3 PUFA ( eicosapentaenoic ( EPA ) and docosahexaenoic acid ( DHA ) ) concentrations .
-OBJECTIVE	To evaluate the extent to which 12 weeks of dietary n-6 PUFA lowering , with or without increased dietary n-3 PUFAs , alters unesterified and esterified plasma n-6 and n-3 PUFA concentrations in subjects with chronic headache .
-METHODS	Secondary analysis of a randomized trial .
-METHODS	Subjects with chronic headache were randomized for 12 weeks to ( 1 ) average n-3 , low n-6 ( L6 ) diet ; or ( 2 ) high n-3 , low n-6 LA ( H3-L6 ) diet .
-METHODS	Esterified and unesterified plasma fatty acids were quantified at baseline ( 0 weeks ) and after 12 weeks on a diet .
-RESULTS	Compared to baseline , the L6 diet reduced esterified plasma LA and increased esterified n-3 PUFA concentrations ( nmol/ml ) , but did not significantly change plasma arachidonic acid ( AA , 20:4 n-6 ) concentration .
-RESULTS	In addition , unesterified EPA concentration was increased significantly among unesterified fatty acids .
-RESULTS	The H3-L6 diet decreased esterified LA and AA concentrations , and produced more marked increases in esterified and unesterified n-3 PUFA concentrations .
-CONCLUSIONS	Dietary n-6 PUFA lowering for 12 weeks significantly reduces LA and increases n-3 PUFA concentrations in plasma , without altering plasma AA concentration .
-CONCLUSIONS	A concurrent increase in dietary n-3 PUFAs for 12 weeks further increases n-3 PUFA plasma concentrations and reduces AA .
-
-###24656221
-OBJECTIVE	Cognitive behaviour therapy ( CBT ) has been found to reduce the impact of menopausal symptoms , hot flushes and night sweats .
-OBJECTIVE	This study investigates the moderators and mediators of CBT for women who had problematic menopausal symptoms following breast cancer treatment .
-METHODS	Analysis of 96 patients with breast cancer induced menopausal symptoms recruited to the MENOS1 trial ; 47 were randomly assigned to Group CBT and 49 to usual care .
-METHODS	Questionnaires were completed at baseline , 9 and 26 weeks post randomisation .
-METHODS	Potential moderators and mediators , including sociodemographic , clinical and psychological factors , of the treatment effect on the primary outcome were examined .
-METHODS	Hot Flush Problem Rating .
-RESULTS	CBT was effective at reducing problem rating at 9 weeks regardless of age , BMI , time since breast cancer diagnosis , menopausal status at time of diagnosis , or type of cancer treatment ( radiotherapy or chemotherapy or endocrine treatment ) .
-RESULTS	The treatment effect was significantly greater in women not receiving chemotherapy , those with higher levels of psychological distress at baseline and for non-white women .
-RESULTS	Beliefs about control/coping with hot flushes were the main mediators of improvement in problem rating following CBT .
-RESULTS	Beliefs about hot flushes in a social context , depressed mood and sleep problems were also identified as mediators .
-CONCLUSIONS	These findings suggest that CBT is widely applicable for breast cancer patients who are experiencing treatment related menopausal symptoms , and that CBT works mainly by changing beliefs and improving mood and sleep .
-
-###25985806
-OBJECTIVE	Opioid-induced androgen deficiency ( OPIAD ) affects patients treated with opioid analgesics .
-OBJECTIVE	The norepinephrine reuptake inhibitor ( NRI ) and - opioid receptor ( MOR ) agonist activities of tapentadol may result in tapentadol having less effect on serum androgen concentrations than analgesics acting through the MOR alone , such as morphine and oxycodone .
-OBJECTIVE	The objectives of this publication are to 1 ) evaluate the effects of tapentadol ( NUCYNTA and NUCYNTA extended release [ ER ] ) on sex hormone concentrations in healthy male volunteers ( vs placebo and morphine ) and patients with osteoarthritis ( vs placebo and oxycodone ) , and 2 ) present a mechanistic hypothesis explaining how the combined MOR agonist and NRI activities of tapentadol may result in less impact on androgen concentrations .
-METHODS	Three clinical studies were conducted : study 1 ( single-dose comparison study vs morphine in healthy volunteers ) , study 2 ( single-dose-escalation study in healthy volunteers without an active comparator ) , and study 3 ( multiple-dose study vs oxycodone in patients with osteoarthritis ) .
-METHODS	Studies 1 and 2 were conducted at medical research centers in Germany and the United Kingdom ; study 3 was conducted at primary and secondary care centers and medical research centers in the United States .
-METHODS	All three studies were randomized , double blind , and placebo controlled .
-METHODS	Concentrations of testosterone , luteinizing hormone ( LH ) , and follicle-stimulating hormone ( FSH ; study 3 only ) were evaluated at 6 and 24 hours postdose in studies 1 and 2 , respectively , and at varying time points postdose in study 3 .
-RESULTS	In study 1 , mean serum total testosterone concentrations in healthy male volunteers were similar at baseline for all treatment periods ; 6 hours after dosing , mean concentrations were comparable between placebo ( 8.6 nmol/L ) and tapentadol immediate release ( IR ; 43 mg , 8.8 nmol/L ; 86 mg , 9.3 nmol/L ) , but were lower following administration of morphine IR 30 mg ( 5.4 nmol/L ) .
-RESULTS	In study 2 , there were no or minimal changes in testosterone in the therapeutic dose range with tapentadol IR ( 75-100 mg ) , and there was a modest decrease that appeared to level off in the supratherapeutic range ( 125-175 mg ) ; mean testosterone and LH concentrations with all doses remained within normal ranges ( testosterone , 4.56-28 .2 nmol/L ; LH , 2.9-4 .6 U/L ) .
-RESULTS	In study 3 , the decrease in the mean [ standard deviation ] testosterone concentration from baseline to endpoint for male patients receiving tapentadol ER ( 100 mg , -1.9 [ 0.71 ] nmol/L ; 200 mg , -2.1 [ 0.93 ] nmol/L ) was numerically smaller compared to oxycodone CR ( 20 mg , -2.7 [ 0.93 ] nmol/L ) , but higher compared to placebo ( -0.3 [ 1.62 ] nmol/L ) .
-CONCLUSIONS	These results suggest that tapentadol , which has combined MOR and NRI activities , may have a lower impact on sex hormone concentrations than pure opioid analgesics , such as morphine or oxycodone .
-CONCLUSIONS	The data and mechanistic rationale presented herein provide a justification for conducting additional hypothesis testing studies , and are not intended to be used as a basis for clinical decision making .
-CONCLUSIONS	Future studies may help elucidate whether the observed trends are clinically significant and would translate into a reduced incidence of OPIAD .
-
-###24229754
-OBJECTIVE	Evaluate the 8-week efficacy and safety of desvenlafaxine at the recommended dose of 50 mg/d in perimenopausal and postmenopausal women with major depressive disorder ( MDD ) based on the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , Text Revision .
-METHODS	This phase 4 , multicenter , parallel-group , randomized , double-blind , placebo-controlled study was conducted from June 30 , 2010 , to June 8 , 2011 .
-METHODS	Patients received placebo or desvenlafaxine 50 mg/d ( 1:1 ratio ; n = 217 in each group ) .
-METHODS	The primary outcome measure was the change at week 8 in the 17-item Hamilton Depression Rating Scale ( HDRS17 ) total score .
-METHODS	Secondary outcome measures included change in the Sheehan Disability Scale ( SDS ) , the Clinical Global Impressions-Improvement scale ( CGI-I ) , the Montgomery-Asberg Depression Rating Scale ( MADRS ) , and the Visual Analog Scale-Pain Intensity ( VAS-PI ) .
-RESULTS	At end point , compared to placebo , desvenlafaxine was associated with a significantly greater decrease in HDRS17 total scores ( last-observation-carried-forward analysis ; adjusted mean change from baseline -9.9 vs -8.1 , respectively ; P = .004 ) and significant improvements on the CGI-I ( P < .001 ) , MADRS ( P = .002 ) , SDS ( P = .038 ) , and VAS-PI ( P < .001 ) .
-RESULTS	Improvements on the SDS and VAS-PI reached significance by week 2 .
-RESULTS	Desvenlafaxine was generally safe and well tolerated .
-CONCLUSIONS	Short-term treatment with desvenlafaxine 50 mg/d was effective for the treatment of MDD in perimenopausal and postmenopausal women , with significant benefits on pain and functional outcomes evident as early as week 2 .
-CONCLUSIONS	The safety and tolerability of desvenlafaxine were consistent with data in other populations .
-BACKGROUND	ClinicalTrials.gov identifier : NCT01121484 .
-
-###24452791
-OBJECTIVE	Anemia is associated with poor tumor control .
-OBJECTIVE	It was previously observed that accelerated radiotherapy combined with carbogen breathing and nicotinamide ( ARCON ) can correct this adverse outcome in patients with head and neck cancer .
-OBJECTIVE	The purpose of this study was to validate this observation based on data from a randomized trial .
-METHODS	Of 345 patients with cT2-4 laryngeal cancer , 174 were randomly assigned to accelerated radiotherapy and 171 to ARCON .
-METHODS	Hemoglobin levels , measured before treatment , were defined as low when < 7.5 mmol/L for women and < 8.5 mmol/L for men .
-METHODS	The hypoxia marker pimonidazole was used to assess the oxygenation status in tumor biopsies .
-METHODS	Data were analyzed 2 years after inclusion of the last patient .
-RESULTS	Pretreatment hemoglobin levels were available and below normal in 27 of 173 ( 16 % ) accelerated radiotherapy and 27 of 167 ( 16 % ) ARCON patients .
-RESULTS	In patients with normal pretreatment , hemoglobin levels treatment with ARCON had no significant effect on 5-year loco-regional control ( LRC , 79 % versus 75 % ; P = 0.44 ) and disease-free survival ( DFS , 75 % vs. 70 % ; P = 0.46 ) compared with accelerated radiotherapy .
-RESULTS	However , in patients with low pretreatment , hemoglobin levels ARCON significantly improved 5-year LRC ( 79 % vs. 53 % ; P = 0.03 ) and DFS ( 68 % vs. 45 % ; P = 0.04 ) .
-RESULTS	In multivariate analysis including other prognostic factors , pretreatment hemoglobin remained prognostic for LRC and DFS in the accelerated radiotherapy treatment arm .
-RESULTS	No correlation between pretreatment hemoglobin levels and pimonidazole uptake was observed .
-CONCLUSIONS	Results from the randomized phase III trial support previous observations that ARCON has the potential to correct the poor outcome of cancer patients with anemia ( ClinicalTrials.gov number , NCT00147732 ) .
-
-###25842726
-OBJECTIVE	To investigate the effect of different heat-stimulating time lengths on lower back pain .
-METHODS	Forty participants were randomly assigned to four groups of various heating time lengths .
-METHODS	The short heating time length group ( SL ) , moderate heating time length group ( ML ) , and long heating time length group ( LL ) respectively received 15 , 30 , and 60 min of moxibustion therapy stimulating the acupoint Guanyuan ( CV 4 ) .
-METHODS	The conventional acupuncture group ( CA ) received needle acupuncture treatment as a control group .
-METHODS	The participants were treated continuously over a 2-week treatment period for a total of 10 sessions , with five sessions given per week .
-METHODS	Participants were assessed weekly by blinded assessors , using the visual analogue scale ( VAS ) and Roland Morris Questionnaire ( RMQ ) .
-RESULTS	The VAS and RMQ scores reduced in all four groups during treatment .
-RESULTS	There were significant differences in VAS scores ( P < 0.01 ) and RMQ scores ( P < 0.01 ) between before treatment and after 2 weeks of treatment in the LL group .
-RESULTS	After treatment , the LL group reported significantly lower VAS scores compared with the CA group , ML group , and SL group ( P < 0.05 ) .
-CONCLUSIONS	The long and moderate lengths of heat-stimulating time of 30 and 60 min may be more effective for relieving lower back pain than that of short stimulating time lengths .
-
-###24687921
-OBJECTIVE	In a recent phase II study of onartuzumab ( MetMAb ) , patients whose non-small cell lung cancer ( NSCLC ) tissue scored as positive for MET protein by immunohistochemistry ( IHC ) experienced a significant benefit with onartuzumab plus erlotinib ( O+E ) versus erlotinib .
-OBJECTIVE	We describe development and validation of a standardized MET IHC assay and , retrospectively , evaluate multiple biomarkers as predictors of patient benefit .
-METHODS	Biomarkers related to MET and/or EGF receptor ( EGFR ) signaling were measured by IHC , FISH , quantitative reverse transcription PCR , mutation detection techniques , and ELISA .
-RESULTS	A positive correlation between IHC , Western blotting , and MET mRNA expression was observed in NSCLC cell lines/tissues .
-RESULTS	An IHC scoring system of MET expression taking proportional and intensity-based thresholds into consideration was applied in an analysis of the phase II study and resulted in the best differentiation of outcomes .
-RESULTS	Further analyses revealed a nonsignificant overall survival ( OS ) improvement with O+E in patients with high MET copy number ( mean5 copies/cell by FISH ) ; however , benefit was maintained in `` MET IHC-positive '' / MET FISH-negative patients ( HR , 0.37 ; P = 0.01 ) .
-RESULTS	MET , EGFR , amphiregulin , epiregulin , or HGF mRNA expression did not predict a significant benefit with onartuzumab ; a nonsignificant OS improvement was observed in patients with high tumor MET mRNA levels ( HR , 0.59 ; P = 0.23 ) .
-RESULTS	Patients with low baseline plasma hepatocyte growth factor ( HGF ) exhibited an HR for OS of 0.519 ( P = 0.09 ) in favor of onartuzumab treatment .
-CONCLUSIONS	MET IHC remains the most robust predictor of OS and progression-free survival benefit from O+E relative to all examined exploratory markers .
-
-###24641883
-OBJECTIVE	Energy deficit ( ED ) diminishes fat-free mass ( FFM ) with concomitant reductions in anabolic hormone secretion .
-OBJECTIVE	A modest increase in protein to recommended dietary allowance ( RDA ) levels during ED minimally attenuates decrements in insulin-like growth factor-I ( IGF-I ) .
-OBJECTIVE	The impact of dietary protein above the RDA on circulating anabolic hormones and their relationships with FFM in response to ED are not well described .
-METHODS	Thirty-three adults were assigned diets providing protein at 0.8 ( RDA ) , 1.6 ( 2-RDA ) , and 2.4 ( 3-RDA ) g/kg/d for 31days .
-METHODS	Testosterone , sex-hormone binding globulin ( SHBG ) and IGF-I system components were assessed after a 10-day period of weight-maintenance ( WM ) and after a 21-day period of ED ( 40 % ) achieved by an increase in energy expenditure and decreased energy intake .
-METHODS	Associations between the change in FFM and anabolic hormone levels were determined .
-RESULTS	As compared to WM and regardless of dietary protein intake , total and free testosterone , total IGF-I , and acid-labile subunit decreased ( P < 0.05 ) , whereas SHBG and IGF binding proteins-1 , -2 , and -3 increased ( P < 0.05 ) during ED .
-RESULTS	There were no energy-by-protein interactions on any hormones or IGF-I system components measured .
-RESULTS	Changes in FFM in response to ED were negatively associated with acid-labile subunit ( ALS ) ( r = -0.62 , P < 0.05 ) in 2-RDA ; however , no other relationships were observed .
-CONCLUSIONS	Consuming a high protein diet does not impact the androgenic and IGF-I system response to ED .
-CONCLUSIONS	These data suggest that the protective effects of high protein diets on FFM during ED are likely not influenced by anabolic hormone concentrations .
-
-###24330449
-BACKGROUND	After renal transplantation , postoperative pain is usually mild to moderate .
-BACKGROUND	Postoperative pain is a concern and administration of systemic analgesic may be difficult because of underlying co-morbidities and variable responses of the graft .
-BACKGROUND	The transversus abdominis plane ( TAP ) block is one of the different approaches for postoperative pain relief following abdominal surgeries .
-BACKGROUND	We evaluated analgesic efficacy of TAP block on early postoperative pain by numeric rating scale ( NRS ) and morphine consumption during the first 24 hours after kidney transplantation .
-METHODS	Forty-four patients , scheduled as kidney recipients were randomized into two equal groups and were anesthetized with the same technique .
-METHODS	After the induction of anesthesia , 15mL of 0.25 % Bupivacaine plus 5/ml epinephrine or saline was deposited into the transversus abdominis neuro-fascial plane on the side of surgery by ultrasound guide .
-METHODS	Each patient was assessed by a blinded investigator using NRS at 1st , 4th , 8th , 12th , and 24th hour postoperatively .
-RESULTS	Demographic data were not significantly different between the study groups .
-RESULTS	There was significant difference in median of NRS score measured at all time points in the study groups ( P < 0.001 ) .
-RESULTS	The 24-hour morphine consumption ( meanSD ) was 10.89.5 mg in bupivacaine group compared with 41.23.8 mg in the saline group ( P = 0.001 ) .
-RESULTS	There was statistically significant reduction in intraoperative fentanyl consumption in the TAP group 12020g compared to the control group 35824g ( P = 0.001 ) .
-RESULTS	In study group 4 patients and in control group 90 patients received morphine titration for pain relief ( P = 0.03 ) .
-RESULTS	There was no complication in the study groups related to nerve block .
-RESULTS	Only two patients in saline group had nausea ( P = 0.07 ) .
-RESULTS	None of our patients received any other oral or IV rescue medication .
-CONCLUSIONS	Ultrasound TAP block can reduce postrenal transplantation pain and the amount of opioids consumption intraoperatively and during the first 24 hours after surgery in kidney recipients .
-
-###24999963
-BACKGROUND	Elevated symmetric dimethylarginine ( SDMA ) has been shown to predict cardiovascular events and all cause mortality in diverse populations .
-BACKGROUND	The potential role of SDMA as a risk marker in renal transplant recipients ( RTR ) has not been investigated .
-METHODS	We analyzed SDMA in the placebo arm of the Assessment of Lescol in Renal Transplantation study , a randomized controlled trial of fluvastatin in RTR .
-METHODS	Mean follow-up was 5.1 years .
-METHODS	Patients were grouped into quartiles based on SDMA levels at study inclusion .
-METHODS	Relationships between SDMA and traditional risk factors for graft function and all-cause mortality were analyzed in 925 RTR using univariate and multivariate survival analyses .
-RESULTS	In univariate analysis , SDMA was significantly associated with renal graft loss , all-cause death , and major cardiovascular events .
-RESULTS	After adjustment for established risk factors including estimated glomerular filtration rate , an elevated SDMA-level ( 4th quartile , > 1.38 mol/L ) was associated with renal graft loss ; hazard ratio ( HR ) , 5.51 ; 95 % confidence interval ( CI ) , 1.95-15 .57 ; P = 0.001 , compared to the 1st quartile .
-RESULTS	Similarly , SDMA in the 4th quartile was independently associated with all-cause mortality ( HR , 4.56 ; 95 % CI , 2.15-9 .71 ; P < 0.001 ) , and there was a strong borderline significant trend for an association with cardiovascular mortality ( HR , 2.86 ; 95 % CI , 0.99-8 .21 ; P = 0.051 ) .
-CONCLUSIONS	In stable RTR , an elevated SDMA level is independently associated with increased risk of all-cause mortality and renal graft loss .
-
-###25112307
-BACKGROUND	Medication-overuse headache ( MOH ) is common in the general population .
-BACKGROUND	We investigated effectiveness of brief intervention ( BI ) for achieving drug withdrawal in primary care patients with MOH .
-METHODS	The study was double-blind , pragmatic and cluster-randomised controlled .
-METHODS	A total of 25,486 patients ( age 18-50 ) from 50 general practitioners ( GPs ) were screened for MOH .
-METHODS	GPs defined clusters and were randomised to receive BI training ( 23 GPs ) or to continue business as usual ( BAU ; 27 GPs ) .
-METHODS	The Severity of Dependence Scale was applied as a part of the BI .
-METHODS	BI involved feedback about individual risk of MOH and how to reduce overuse .
-METHODS	Primary outcome measures were reduction in medication and headache days/month 3 months after the intervention and were assessed by a blinded clinical investigator .
-RESULTS	42 % responded to the postal screening questionnaire , and 2.4 % screened positive for MOH .
-RESULTS	A random selection of up to three patients with MOH from each GP were invited ( 104 patients ) , 75 patients were randomised and 60 patients included into the study .
-RESULTS	BI was significantly better than BAU for the primary outcomes ( p < 0.001 ) .
-RESULTS	Headache and medication days were reduced by 7.3 and 7.9 ( 95 % CI 3.2 to 11.3 and 3.2 to 12.5 ) days/month in the BI compared with the BAU group .
-RESULTS	Chronic headache resolved in 50 % of the BI and 6 % of the BAU group .
-CONCLUSIONS	The BI method provides GPs with a simple and effective instrument that reduces medication-overuse and headache frequency in patients with MOH .
-BACKGROUND	NCT01314768 .
-
-###25341169
-OBJECTIVE	The aim of this study was to determine both the value of gadolinium-enhanced MRI in children with suspected acute appendicitis and the best sequences for detecting acute appendicitis , to thereby decrease imaging time .
-METHODS	This was a retrospective review of pediatric patients with suspected appendicitis who had undergone MRI at our institution between 2010 and 2011 after an indeterminate ultrasound examination .
-METHODS	MRI examinations included T1-weighted unenhanced and contrast-enhanced , T2-weighted , and balanced steady-state free precession ( SSFP ) sequences in axial and coronal planes .
-METHODS	Sequences were reviewed together and individually by five radiologists who were blinded to the final diagnosis .
-METHODS	Radiologists were asked to score their confidence of appendicitis diagnosis using a 5-point scale .
-METHODS	The diagnostic performance of each MR sequence was obtained by comparing the mean area under the curve ( AUC ) using receiver operating characteristic ( ROC ) analysis .
-RESULTS	A total of 49 patients with clinically suspected appendicitis were included , of whom 16 received a diagnosis of appendicitis .
-RESULTS	The mean AUCs for reviewing all sequences together , contrast-enhanced sequences alone , T2-weighted sequences alone , and balanced SSFP alone were 0.984 , 0.979 , 0.944 , and 0.910 , respectively .
-RESULTS	No significant difference was observed between reviewing all sequences together versus contrast-enhanced sequences alone ( p = 0.90 ) and T2-weighted sequences alone ( p = 0.23 ) .
-RESULTS	A significant difference was observed between contrast-enhanced sequences and balanced SSFP ( p < 0.03 ) .
-CONCLUSIONS	Gadolinium-enhanced images and T2-weighted images are most helpful in the assessment of acute appendicitis in the pediatric population .
-CONCLUSIONS	These findings have led to protocol modifications that have reduced imaging time .
-
-###24753225
-BACKGROUND	There is an urgent need for more effective treatments for major depressive disorder ( MDD ) .
-BACKGROUND	As understanding of the cognitive and affective neuroscience underlying psychiatric disorders expands , so do opportunities to develop interventions that capitalize on the capacity for brain plasticity .
-BACKGROUND	Cognitive training is one such strategy .
-BACKGROUND	In this article , we report a proof-of-concept study of a novel cognitive-emotional training exercise designed to enhance cognitive control for emotional information processing and targeting components of the neural networks that have been implicated in MDD .
-METHODS	Twenty-one participants with MDD in a current episode were randomly assigned to one of the two treatment conditions : 11 participating in a cognitive-emotional training paradigm ( emotional faces memory task ( EFMT ) ) involving eight sessions over 4 weeks , and 10 participating in an active control condition ( control training , CT ) .
-METHODS	Assessments of MDD symptoms , negative affective bias in cognitive processing , and neurocognition ( attention and working memory ) were administered at baseline and after 4 weeks .
-RESULTS	Participants in the EFMT group exhibited a greater reduction in MDD symptoms compared to the CT group , and 6 of the 11 EFMT participants achieved clinical response ( 50 % reduction in symptoms ) .
-RESULTS	EFMT participants also exhibited changes in negative affective bias in the hypothesized direction whereas the CT participants did not .
-RESULTS	Both groups exhibited similar , small improvements in attention and working memory .
-CONCLUSIONS	Cognitive-emotional training may represent a feasible and effective intervention strategy for MDD .
-CONCLUSIONS	This proof-of-concept study highlights the need for future studies to fully understand the effectiveness , and mechanisms of effect , of these training strategies .
-
-###24423077
-BACKGROUND	Uncertainty exists regarding the optimal method to estimate glomerular filtration rate ( GFR ) for disease detection and monitoring .
-BACKGROUND	Widely used GFR estimates have not been validated in British ethnic minority populations .
-METHODS	Iohexol measured GFR will be the reference against which each estimating equation will be compared .
-METHODS	The estimating equations will be based upon serum creatinine and/or cystatin C.
-METHODS	The eGFR-C study has 5 components : 1 ) A prospective longitudinal cohort study of 1300 adults with stage 3 chronic kidney disease followed for 3 years with reference ( measured ) GFR and test ( estimated GFR [ eGFR ] and urinary albumin-to-creatinine ratio ) measurements at baseline and 3 years .
-METHODS	Test measurements will also be undertaken every 6 months .
-METHODS	The study population will include a representative sample of South-Asians and African-Caribbeans .
-METHODS	People with diabetes and proteinuria ( ACR 30 mg/mmol ) will comprise 20-30 % of the study cohort .2 ) A sub-study of patterns of disease progression of 375 people ( 125 each of Caucasian , Asian and African-Caribbean origin ; in each case containing subjects at high and low risk of renal progression ) .
-METHODS	Additional reference GFR measurements will be undertaken after 1 and 2 years to enable a model of disease progression and error to be built .3 ) A biological variability study to establish reference change values for reference and test measures .4 ) A modelling study of the performance of monitoring strategies on detecting progression , utilising estimates of accuracy , patterns of disease progression and estimates of measurement error from studies 1 ) , 2 ) and 3 ) .5 ) A comprehensive cost database for each diagnostic approach will be developed to enable cost-effectiveness modelling of the optimal strategy.The performance of the estimating equations will be evaluated by assessing bias , precision and accuracy .
-METHODS	Data will be modelled as a linear function of time utilising all available ( maximum 7 ) time points compared with the difference between baseline and final reference values .
-METHODS	The percentage of participants demonstrating large error with the respective estimating equations will be compared .
-METHODS	Predictive value of GFR estimates and albumin-to-creatinine ratio will be compared amongst subjects that do or do not show progressive kidney function decline .
-CONCLUSIONS	The eGFR-C study will provide evidence to inform the optimal GFR estimate to be used in clinical practice .
-BACKGROUND	ISRCTN42955626 .
-
-###24277778
-BACKGROUND	Cardiovascular disease ( CVD ) accounts for 30 % of UK deaths .
-BACKGROUND	It is associated with modifiable lifestyle factors , including insufficient consumption of fruit and vegetables ( F&V ) .
-BACKGROUND	Lay health trainers ( LHTs ) offer practical support to help people develop healthier behaviour and lifestyles .
-BACKGROUND	Our two-group pilot randomized controlled trial ( RCT ) investigated the effectiveness of LHTs at promoting a heart-healthy lifestyle among adults with at least one risk factor for CVD to inform a full-scale RCT .
-METHODS	Eligible adults ( aged 21-78 years ) , recruited from five practices serving deprived populations , were randomized to health information leaflets plus LHTs ' support for 3 months ( n = 76 ) versus health information leaflets alone ( n = 38 ) .
-RESULTS	We recruited 114 participants , with 60 % completing 6 month follow-up .
-RESULTS	Both groups increased their self-reported F&V consumption and we found no evidence for LHTs ' support having significant added impact .
-RESULTS	Most participants were relatively less deprived , as were the LHTs we were able to recruit and train .
-CONCLUSIONS	Our pilot demonstrated that an LHT 's RCT whilst feasible faces considerable challenges .
-CONCLUSIONS	However , to justify growing investment in LHTs , any behaviour changes and sustained impact on those at greatest need should be demonstrated in an independently evaluated , robust , fully powered RCT .
-
-###26152000
-OBJECTIVE	To evaluate time-limited hydrotubation combined with clomiphene citrate as treatment for unexplained infertility .
-METHODS	In this unblinded , randomized controlled trial of patients who had unexplained infertility , 40 patients were treated with time-limited hydrotubation ( saline , 20 ml ; flushed within 20 to 30 seconds ) and clomphene citrate ( total , 70 cycles ) and 40 patients were treated with clomiphene citrate alone ( total , 74 cycles ) .
-METHODS	All women underwent an ovulation induction protocol with clomiphene citrate ( 100 mg/d orally for five days , from day 3 to day 7 of the cycle ) .
-METHODS	Hydrotubation was performed after detection of the dominant follicle .
-RESULTS	There were 15 pregnancies in the 80 patients ( 19 % ) ( total , 144 stimulated cycles ; 10 % pregnancies per cycle ) .
-RESULTS	The frequency of clinical pregnancy per cycle was significantly greater in patients who were treated with hydrotubation and clomiphene citrate ( nine pregnancies per cycle [ 13 % ] ) than those treated with clomiphene citrate alone ( two pregnancies per cycle [ 3 % ] ; odds ratio , 5.3 ; 95 % confidence interval , 1.1 to 25.5 ; p 0.05 ) .
-RESULTS	The frequency of pregnancy per patient ( total , clinical , or chemical ) was similar for the two treatment groups .
-RESULTS	The frequency of live birth or abortion per cycle or patient was similar between the two treatment groups .
-CONCLUSIONS	Time-limited hydrotubation and clomiphene citrate may increase the frequency of clinical pregnancy per cycle in women who have unexplained infertility .
-
-###24338756
-BACKGROUND	Although colonoscopy is the standard procedure in the diagnosis of colorectal neoplasia , a significant number of clinical relevant lesions may be missed even by experienced endoscopists using current technology .
-BACKGROUND	A transparent cap mounted at the tip of a colonoscope may be an easy way to extend the visual field during colonoscopy and may improve the detection rate of mucosal lesions .
-METHODS	The significance of cap assisted ( CAC ) vs. conventional colonoscopy ( CC ) on polyp detection rate was evaluated in a prospective randomized controlled trial in 504 patients .
-RESULTS	CC and CAC detected polyps in 39.3 % and 31.8 , not significantly different .
-RESULTS	There was also no significant difference between CAC and CC according to age , sex , indication for colonoscopy , diverticulosis , sedation , bowel cleansing , withdrawal time , time/number of attempts to intubate the cecal walve , number , localization , size or histology of polyps , .
-RESULTS	However , the time to reach the cecal floor and the overall time of colonoscopy were significantly lower for CAC ( 1 minute ) .
-CONCLUSIONS	CAC was without clinical impact on polyp detection rate or performance of colonoscopy .
-
-###25116294
-OBJECTIVE	Although most intensive care unit ( ICU ) admissions originate in the emergency department ( ED ) , a substantial number of admissions arrive from hospital wards .
-OBJECTIVE	Patients transferred from the hospital ward often share clinical characteristics with those admitted from the ED , but family expectations may differ .
-OBJECTIVE	An understanding of the impact of ICU admission source on family perceptions of end-of-life care may help improve patient and family outcomes by identifying those at risk for poor outcomes .
-METHODS	This was a cohort study of patients with chronic illness and acute respiratory failure requiring mechanical ventilation who died after admission to an ICU in any of the 14 participating hospitals in the Seattle-Tacoma area between 2003 and 2008 ( n = 1,500 ) .
-METHODS	Using regression models adjusted for hospital site and patient - , nurse - and family-level characteristics , we examined associations between ICU admission source ( hospital ward vs. ED ) and ( 1 ) family ratings of satisfaction with ICU care ; ( 2 ) family and nurse ratings of quality of dying ; ( 3 ) chart-based indicators of palliative care .
-RESULTS	Admission from the hospital ward was associated with lower family ratings of quality of dying [ -0.90 , 95 % confidence interval ( CI ) -1.54 , -0.26 , p = 0.006 ] and satisfaction ( total score -3.97 , 95 % CI -7.89 , -0.05 , p = 0.047 ; satisfaction with care domain score -5.40 , 95 % CI -9.44 , -1.36 , p = 0.009 ) .
-RESULTS	Nurses did not report differences in quality of dying .
-RESULTS	Patients from hospital wards were less likely to have family conferences [ odds ratio ( OR ) 0.68 , 95 % CI 0.52 , 0.88 , p = 0.004 ] or discussion of prognosis in the first 72 h after ICU admission ( OR 0.72 , 95 % CI 0.56 , 0.91 , p = 0.007 ) but were more likely to receive spiritual care ( OR 1.48 , 95 % CI 1.14 , 1.93 , p = 0.003 ) or have life support withdrawn ( OR 1.38 , 95 % CI 1.04 , 1.82 , p = 0.025 ) .
-CONCLUSIONS	Admission from the hospital ward is associated with family perceptions of a lower quality of dying and less satisfaction with ICU care .
-CONCLUSIONS	Differences in receipt of palliative care suggest that family of patients from the hospital ward receive less communication .
-CONCLUSIONS	Nurse ratings of quality of dying did not significantly differ by ICU admission source , suggesting dissimilarities between family and nurse perspectives .
-CONCLUSIONS	This study identifies a patient population at risk for poor quality palliative and end-of-life care .
-CONCLUSIONS	Future studies are needed to identify interventions to improve care for patients who deteriorate on the wards following hospital admission .
-
-###24232445
-OBJECTIVE	Hypericum perforatum ( St John 's wort ) is used to treat depression , but the effectiveness has not been established .
-OBJECTIVE	Recent guidelines described the analysis of clinical trials with missing data , inspiring the reanalysis of this trial using proper missing data methods .
-OBJECTIVE	The objective was to determine whether hypericum was superior to placebo in treating major depression .
-METHODS	A placebo-controlled , randomized clinical trial was conducted for 8 weeks to determine the effectiveness of hypericum or sertraline in reducing depression , measured using the Hamilton depression scale.We performed sensitivity analyses under different assumptions about the missing data process .
-RESULTS	Three hundred forty participants were randomized , with 28 % lost to follow-up .
-RESULTS	The missing data mechanism was not missing completely at random .
-RESULTS	Under missing at random assumptions , some sensitivity analyses found no difference between either treatment armand placebo , while some sensitivity analyses found a significant difference from baseline to week 8 between sertraline and placebo ( -1.28 , 95 % credible interval [ -2.48 ; -0.08 ] ) , but not between hypericum and placebo ( 0.56 , [ -0.64 ; 1.76 ] ) .
-RESULTS	The results were similar when the missing data process was assumed to be missing not at random .
-CONCLUSIONS	There is no difference between hypericum and placebo , regardless of the assumption about the missing data process .
-CONCLUSIONS	There is a significant difference between sertraline and placebo with some statistical-methods used .
-CONCLUSIONS	It is important to conduct an analysis that takes account of missing data using valid statistically principled methods .
-CONCLUSIONS	The assumptions about the missing data process could influence the results .
-
-###24875033
-BACKGROUND	An important factor in the functional results after total knee arthroplasty is the achieved maximal flexion .
-BACKGROUND	The main purpose of this study was to compare the maximal knee flexion one year after surgery in patients who received either the bicruciate substituting knee system or the conventional posterior stabilized system .
-METHODS	In a prospective randomized controlled trial , 124 patients presenting with osteoarthritis received the bicruciate substituting or the conventional posterior stabilized prosthesis .
-METHODS	The primary outcome was the maximum flexion angle at one year postoperatively on a lateral radiograph made with the supine patient using manual force to bend the knee .
-METHODS	Secondary outcomes were active flexion ( lying and standing ) , the Knee Society Score , the Patella Scoring System score , the University of California Los Angeles score , the number and type of adverse device effects , and visual analog scale satisfaction up to two years postoperatively .
-METHODS	The outcome measures of both groups were compared using one-sided t tests and non-parametric alternatives , with a significance level of p < 0.05 .
-RESULTS	No significant differences between the two groups were observed in maximal flexion on radiographs and in active flexion at baseline .
-RESULTS	The median maximal flexion on radiographs was 127 ( range , 83 to 150 ) for the bicruciate substituting group and 125 ( range , 74 to 145 ) for the conventional posterior stabilized group .
-RESULTS	The two groups showed comparable two-year results with respect to the Knee Society Score , the Patella Scoring System , the University of California Los Angeles score , and visual analog scale satisfaction .
-RESULTS	In the bicruciate substituting group , forty-one adverse device effects in twenty-six patients were reported , including three total system revisions and fourteen manipulations under anesthesia , compared with the conventional posterior stabilized group , in which sixteen adverse device effects were observed in thirteen patients , including six manipulations under anesthesia ( p = 0.012 ) .
-CONCLUSIONS	Patients who receive a bicruciate substituting system compared with those who receive a conventional posterior stabilized system have comparable knee flexion characteristics and clinical and functional outcomes but more complications by two years after total knee arthroplasty .
-METHODS	Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .
-
-###25693004
-BACKGROUND	Angiotensin II receptor blockers ( ARBs ) is a well-tolerated class of antihypertensive agents , exhibiting effective antihypertensive and cardiovascular protective function .
-BACKGROUND	The objective of the study was to examine the efficacy and safety of Allisartan Isoproxil , a newly developed , selective , nonpeptide blocker of the angiotensin II type 1 receptor ( AT1R ) , in essential hypertensive patients at low-medium risk .
-RESULTS	A Phase II prospective , randomized , double-blind , placebo-controlled , multicenter trial comparing Allisartan Isoproxil 240mg versus placebo was conducted in essential hypertensive patients at low-medium risk at 8 sites in China .
-RESULTS	After a 2-week placebo baseline period , 275 patients received once-daily treatment with Allisartan Isoproxil 240mg or placebo randomly for 8 weeks .
-RESULTS	Systolic/diastolic blood pressure ( SBP/DBP ) was measured at week 2 , 4 and 8 .
-RESULTS	By the end of treatment , mean reductions from baseline of SBP and DBP in Allisartan Isoproxil and placebo groups were 14.5 / 10.4 and 8.3 / 7.7 mmHg , respectively ( P < 0.01 ) .
-RESULTS	The rate of effective blood pressure control in Allisartan Isoproxil group was significantly higher than in placebo group at week 4 ( 61.3 % vs 50.0 % , P < 0.05 ) and week 8 ( 67.2 % vs 48.6 % , P < 0.01 ) .
-RESULTS	In terms of safety and tolerability , there were no report of death and serious adverse event ( SAE ) in all subjects .
-RESULTS	There was no difference of frequency between two groups in adverse event ( AE ) and adverse drug reaction ( ADR ) ( P > 0.05 ) .
-RESULTS	No one withdraw because of an ADR in two groups .
-RESULTS	124 patients received additional 56 weeks treatment with Allisartan Isoproxil and 84 of them completed the study .
-RESULTS	The rate of effective BP control kept up to 80 % since week 24 .
-RESULTS	No significant clinical change was observed and ADRs were generally mild or moderate during the long-term study .
-CONCLUSIONS	Allisartan Isoproxil 240mg was effective and safe for essential hypertension patients at low-medium risk .
-BACKGROUND	http://www.chictr.org/cn/ ChiCTR-TRC-10000886 .
-
-###24885673
-BACKGROUND	Bipolar I disorder ( BD-I ) is a chronic mental illness characterized by the presence of one or more manic episodes , or both depressive and manic episodes , usually separated by asymptomatic intervals .
-BACKGROUND	Pharmacists can contribute to the management of BD-I , mainly with the use of effective and safe drugs , and improve the patient 's life quality through pharmaceutical care .
-BACKGROUND	Some studies have shown the effect of pharmaceutical care in the achievement of therapeutic goals in different illnesses ; however , to our knowledge , there is a lack of randomized controlled trials designed to assess the effect of pharmacist intervention in patients with BD .
-BACKGROUND	The aim of this study is to assess the effectiveness of the Dader Method for pharmaceutical care in patients with BD-I .
-METHODS	Randomized , controlled , prospective , single-center clinical trial with duration of 12months will be performed to compare the effect of Dader Method of pharmaceutical care with the usual care process of patients in a psychiatric clinic .
-METHODS	Patients diagnosed with BD-I aged between 18 and 65years who have been discharged or referred from outpatients service of the San Juan de Dios Clinic ( Antioquia , Colombia ) will be included .
-METHODS	Patients will be randomized into the intervention group who will receive pharmaceutical care provided by pharmacists working in collaboration with psychiatrists , or into the control group who will receive usual care and verbal-written counseling regarding BD .
-METHODS	Study outcomes will be assessed at baseline and at 3 , 6 , 9 , and 12months after randomization .
-METHODS	The primary outcome will be to measure the number of hospitalizations , emergency service consultations , and unscheduled outpatient visits .
-METHODS	Effectiveness , safety , adherence , and quality of life will be assessed as secondary outcomes .
-METHODS	Statistical analyses will be performed using two-tailed McNemar tests , Pearson chi-square tests , and Student 's t-tests ; a P value < 0.05 will be considered as statistically significant .
-CONCLUSIONS	As far as we know , this is the first randomized controlled trial to assess the effect of the Dader Method for pharmaceutical care in patients with BD-I and it could generate valuable information and recommendations about the role of pharmacists in the improvement of therapeutic goals , solution of drug-related problems , and adherence .
-BACKGROUND	Registration number NCT01750255 on August 6 , 2012 .
-BACKGROUND	First patient randomized on 24 November 2011 .
-
-###24915259
-OBJECTIVE	The disease process leading to clinical type 1 diabetes often starts during the first years of life .
-OBJECTIVE	Early exposure to complex dietary proteins may increase the risk of - cell autoimmunity in children at genetic risk for type 1 diabetes .
-OBJECTIVE	Extensively hydrolyzed formulas do not contain intact proteins .
-OBJECTIVE	To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of diabetes-associated autoantibodies in young children .
-METHODS	A double-blind randomized clinical trial of 2159 infants with HLA-conferred disease susceptibility and a first-degree relative with type 1 diabetes recruited from May 2002 to January 2007 in 78 study centers in 15 countries ; 1078 were randomized to be weaned to the extensively hydrolyzed casein formula and 1081 were randomized to be weaned to a conventional cows ' milk-based formula .
-METHODS	The participants were observed to April 16 , 2013 .
-METHODS	The participants received either a casein hydrolysate or a conventional cows ' milk formula supplemented with 20 % of the casein hydrolysate .
-RESULTS	AND MEASURES : Primary outcome was positivity for at least 2 diabetes-associated autoantibodies out of 4 analyzed .
-RESULTS	Autoantibodies to insulin , glutamic acid decarboxylase , and the insulinoma-associated-2 ( IA-2 ) molecule were analyzed using radiobinding assays and islet cell antibodies with immunofluorescence during a median observation period of 7.0 years ( mean , 6.3 years ) .
-RESULTS	The absolute risk of positivity for 2 or more islet autoantibodies was 13.4 % among those randomized to the casein hydrolysate formula ( n = 139 ) vs 11.4 % among those randomized to the conventional formula ( n = 117 ) .
-RESULTS	The unadjusted hazard ratio for positivity for 2 or more autoantibodies among those randomized to be weaned to the casein hydrolysate was 1.21 ( 95 % CI , 0.94-1 .54 ) , compared with those randomized to the conventional formula , while the hazard ratio adjusted for HLA risk , duration of breastfeeding , vitamin D use , study formula duration and consumption , and region was 1.23 ( 95 % CI , 0.96-1 .58 ) .
-RESULTS	There were no clinically significant differences in the rate of reported adverse events between the 2 groups .
-CONCLUSIONS	Among infants at risk for type 1 diabetes , the use of a hydrolyzed formula , when compared with a conventional formula , did not reduce the incidence of diabetes-associated autoantibodies after 7 years .
-CONCLUSIONS	These findings do not support a benefit from hydrolyzed formula .
-CONCLUSIONS	TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT00179777 .
-
-###24502911
-BACKGROUND	Postural control associated with self-paced movement is critical for balance in frail older adults .
-BACKGROUND	The present work aimed to investigate the effects of a 2D virtual reality-based program on postural control associated with rapid arm movement in this population .
-METHODS	Participants in an upright standing position performed rapid arm-raising movements towards a target .
-METHODS	Practice-related changes were assessed by pre - and post-test comparisons of hand kinematics and centre-of-pressure ( CoP ) displacement parameters measured in a training group and a control group .
-METHODS	During these pre - and post-test sessions , patients have to reach towards yellow balls appearing on the screen , form a standardized upright position ( with 15cm between the two malleoli ) .
-METHODS	Training group patients took part in six sessions of virtual game .
-METHODS	In this , patients were asked to reach their arm towards yellow balls appearing on the screen , from an upright position .
-RESULTS	After training , we observed improvements in arm movements and in the initial phase of CoP displacement , especially in the anticipatory postural adjustments .
-RESULTS	Learning curves for these two types of motor improvements showed different rates .
-RESULTS	These were continuous for the control of the arm movement , and discontinuous for the control of the CoP during the anticipatory postural adjustments .
-CONCLUSIONS	These results suggest that some level of motor ( re ) - learning is maintained in frail patients with low functional reserves .
-CONCLUSIONS	They also suggest that re-learning of anticipatory postural control ( i.e. motor prediction ) is less robust than explicit motor learning involved for the arm reaching .
-CONCLUSIONS	This last point should encourage clinicians to extend the training course duration , even if reaching movement improvements seems acquired , in order to automate these anticipatory postural activities .
-CONCLUSIONS	However , other studies should be done to measure the retention of these two types of learning on a longer-term period .
-
-###24882173
-BACKGROUND	The hippocampal volume is reduced in patients with major depression .
-BACKGROUND	Exercise leads to an increased hippocampal volume in schizophrenia and in healthy old adults .
-BACKGROUND	The effect of exercise on hippocampal volume is potentially mediated by brain derived neurotrophic factor ( BDNF ) , vascular endothelial growth factor ( VEGF ) , and insulin like growth factor 1 ( IGF-1 ) .
-BACKGROUND	The aim of this trial was to assess the effect of an aerobic exercise intervention on hippocampal volume and serum BDNF , VEGF , and IGF-1 in patients with major depression .
-METHODS	Patients were randomized to an aerobic exercise intervention ( n = 41 ) or a control condition ( n = 38 ) .
-METHODS	Both interventions consisted of three supervised sessions per week during a three months period .
-RESULTS	Post-intervention the increase in maximal oxygen uptake was 3.90 ml/kg/min ( SD 5.1 ) in the aerobic exercise group and 0.95 ml/kg/min ( SD 6.2 ) in the control group ( p = 0.03 ) .
-RESULTS	The hippocampal volume , BDNF , VEGF , or IGF-1 did not differ between the two groups .
-RESULTS	Post-hoc we found a positive association between change in hippocampal volume and verbal memory ( Rho = 0.27 ; p = 0.05 ) and change in hippocampal volume and depressive symptoms ( Rho = 0.30 ; p = 0.03 ) .
-CONCLUSIONS	Participation was low in both groups corresponding to an average participation of one session per week .
-CONCLUSIONS	Despite a significant increase in maximal oxygen uptake , a pragmatic exercise intervention did not increase hippocampal volume or resting levels of neurotrophines in out-patients with mild to moderate major depression .
-CONCLUSIONS	Trial identifier : ClinicalTrials.gov ( NCT00695552 ) .
-
-###24726378
-OBJECTIVE	Intra-lesional bony overgrowth ( BO ) identified during or following cartilage repair treatment is being frequently described through subjective reports focusing primarily on incidence .
-OBJECTIVE	Our objective was to quantify the exact volume of intra-lesional BO at 12 months post-cartilage repair treatment , to determine if a correlation exists between the extent of BO and clinical outcomes , and to visualize and characterize the BO .
-METHODS	MRI scans were systematically obtained during a randomized clinical trial for cartilage repair ( Stanish etal. , 2013 ) that compared two microfracture-based treatments in 78 patients .
-METHODS	Semi-automated morphological segmentation of pre-treatment , 1 and 12 months post-treatment scans utilizing a programmed anatomical atlas for all knee bone and cartilage structures permitted three-dimensional reconstruction , quantitative analysis , as well as qualitative characterization and artistic visualization ofBO .
-RESULTS	Limited intra-lesional BO representing only 5.85.7 % of the original debrided cartilage lesion volume was found in 78 patients with available MRIs at 12 months .
-RESULTS	The majority ( 80 % ) of patients had very little BO ( < 10 % ) .
-RESULTS	Most occurrences of BO carried either spotty ( 56.4 % ) or planar ( 6.4 % ) morphological features , and the remaining balance ( 37.2 % ) was qualitatively unobservable by eye .
-RESULTS	Pre-existing BO recurred at 12 months in the same intra-lesional location in 36 % of patients .
-RESULTS	No statistical correlations were found between BO and clinical outcomes .
-CONCLUSIONS	Intra-lesional BO following microfracture-based treatments may not be as severe as previously believed , its incidence is partly explained by pre-existing conditions , and no relationship to clinical outcomes exists at 12 months .
-CONCLUSIONS	Morphologically , observable BO was categorized as comprising either spotty or planar bone .
-
-###25151027
-OBJECTIVE	To evaluate the role of post-surgical medical treatment with GnRHa in patients with DIE ( Deep Infiltrating Endometriosis ) that received complete or incomplete surgery laparoscopic excision .
-METHODS	Hundred fifty-nine patients with deep infiltrating endometriosis of the cul-de-sac and of the rectovaginal septum with pelvic pain undergoing laparoscopic surgery in academic tertiary-care medical center .
-METHODS	Eighty patients underwent complete laparoscopic excision of DIE ( Arm A ) while 79 patients underwent incomplete surgery ( Arm B ) .
-METHODS	After surgery each surgical arm was randomized in two groups : no treatment groups 1A [ 40 pts ] and 1B [ 40 pts ] and GnRHa treatment for 6 months groups 2A [ 40 pts ] and 2B [ 39 pts ] .
-METHODS	Pain recurrence and quality of life were evaluated in follow-up of 12 months and compared between groups .
-RESULTS	No differences were observed between patient groups 1A and 2A .
-RESULTS	Groups 1A , 2A and 2B obtained significantly lower pain scores than those achieved by the group 1B undergoing incomplete surgical treatment and no post-surgical therapy .
-RESULTS	At 1-year follow-up patients treated with en-block resection ( Groups 1A and 2A ) showed the lowest pain scores and the highest quality of life in comparison with the other two groups ( Group 1B and 2B ) .
-CONCLUSIONS	GnRHa administration is followed by a temporary improvement of pain in patients with incomplete surgical treatment .
-CONCLUSIONS	It seems that it has no role on post-surgical pain when the surgeon is able to completely excise DIE implants .
-
-###25012446
-BACKGROUND	Diminished quality of life ( QOL ) is associated with major depressive disorder ( MDD ) .
-METHODS	QOL was assessed in a post-hoc analysis of a double-blind , placebo-controlled trial .
-METHODS	Employed adult outpatients with MDD were randomly assigned to 12 weeks of treatment with desvenlafaxine 50mg/d or placebo .
-METHODS	Changes from baseline in the Short Form of the Quality of Life Enjoyment and Satisfaction Questionnaire ( Q-LES-Q ) item scores at week 12 were analyzed using analysis of covariance with treatment , region , and baseline in the model .
-METHODS	Correlations between change from baseline in the 17-item Hamilton Rating Scale for Depression ( HAM-D17 ) total score and Q-LES-Q scores were computed .
-RESULTS	The intent-to-treat population included 427 patients .
-RESULTS	There were statistically significant improvements from baseline for desvenlafaxine vs placebo in 10 of 16 Q-LES-Q item scores ( P values 0.0441 ) .
-RESULTS	The percentage of patients with severe QOL impairment ( 2 SD below community norm ) at week 12 was significantly lower for desvenlafaxine ( 46 % ) vs placebo ( 62 % ; P = 0.0024 ; baseline : 95 % and 94 % , respectively ) .
-RESULTS	Change in Q-LES-Q total score was highly correlated with change in HAM-D17 score at week 12 , LOCF ( P < 0.0001 ) , and improvement in HAM-D17 total score at week 2 predicted change in Q-LES-Q total score at week 12 for the desvenlafaxine group ( F = 24.89 ; P < 0.0001 ) but not placebo .
-CONCLUSIONS	This analysis excluded patients who were unemployed , had severe comorbidities , and those taking multiple , concomitant medications .
-CONCLUSIONS	Improvement in QOL and depressive symptoms was significantly greater for employed depressed patients treated with desvenlafaxine vs placebo .
-
-###25038064
-BACKGROUND	Although physical exercise improves motor aspects of Parkinson 's disease ( PD ) , it is not clear whether it may also have a neuroprotective effect .
-BACKGROUND	Objective .
-BACKGROUND	In this 2-year follow-up study , we determined whether intensive exercise in the early stages of the disease slows down PD progression .
-METHODS	Forty newly diagnosed patients with PD were treated with rasagiline and randomly assigned to 2 groups : MIRT Group ( two 28-day multidisciplinary intensive rehabilitation treatments [ MIRT ] , at 1-year interval ) and Control Group ( only drug ) .
-METHODS	In both groups , Unified Parkinson 's Disease Rating Scale Section II ( UPDRS II ) , UPDRS III , 6-minute walking test ( 6MWT ) , Timed Up-and-Go test ( TUG ) ; PD Disability Scale ( PDDS ) , and l-dopa equivalents were assessed at baseline ( T0 ) , 6 months ( T1 ) , 1 year ( T2 ) , 18 months ( T3 ) , and 2 years ( T4 ) later .
-RESULTS	Over 2 years , UPDRS II , UPDRS III , TUG , and PDDS differentially progressed in the 2 groups : In the MIRT Group , all scores at T4 were better than at T0 ( all Ps < .03 ) .
-RESULTS	No changes were noted in the Control Group .
-RESULTS	l-dopa equivalent dosages increased significantly only in the Control Group ( P = .0015 ) , with a decrease in the percentages of patients in monotherapy ( T1 40 % ; T2 , T3 , and T4 20 % ) .
-RESULTS	In the MIRT Group , the percentages of such patients remained higher ( T1 and T2 100 % ; T3 89 % ; T4 75 % ) .
-CONCLUSIONS	These results suggest that MIRT might slow down the progression of motor decay , it might delay the need for increasing drug treatment , and thus , it might have a neuroprotective effect .
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-###24292746
-OBJECTIVE	The aim of the present study was to investigate whether the following four markers : vitamin B12 , selenium , vitamin D , and parvalbumin may be used as compliance markers for fish intake .
-METHODS	Blood samples from a randomized cross-over herring intervention study ( n = 32 ) were analysed by HPLC and immunochemistry .
-METHODS	The criteria were that plasma or serum concentrations of candidate compliance markers after the herring diet should increase significantly compared to starting concentrations .
-METHODS	In addition , the reference meat diet should not yield an increase in plasma concentration of the candidate marker .
-RESULTS	Vitamin B12 and selenium met the set criteria for indicating a correlation between the marker and fish intake with significant increases in serum concentrations at 8.9 % ( p = 0.008 ) and 4.6 % ( p = 0.02 ) , respectively , after a 6-week herring intervention ( 5 meals a week ) .
-RESULTS	Parvalbumin and 25-hydroxy vitamin D3 levels did not increase significantly after the herring interventions .
-CONCLUSIONS	Vitamin B12 may be suitable as a compliance marker for fish intake .
-CONCLUSIONS	Although selenium also met the criteria , the change in selenium serum concentrations was small compared to the change in vitamin B12 levels .
-
-###25073573
-OBJECTIVE	To evaluate peripheral nerve safety and clinical efficacy of tanezumab in patients with painful osteoarthritis .
-METHODS	Patients received intravenous tanezumab 5mg , tanezumab 10mg , or placebo every 8 weeks for 24 weeks .
-METHODS	Neurological safety was evaluated via a composite score ( nerve conduction attributes and heart rate variability with deep breathing ; 5NC + HRdb ) , intraepidermal nerve fiber ( IENF ) density , and clinical assessments .
-METHODS	Efficacy and general safety were also evaluated .
-RESULTS	The study was stopped prematurely by an FDA partial clinical hold ( joint safety issues in other studies ) .
-RESULTS	Differences in change from baseline to Week 24 in 5NC + HRdb were not significant .
-RESULTS	Tanezumab 5mg vs placebo exceeded the prespecified clinically important difference using last observation carried forward imputation , but not with observed data or when patients with evidence of neuropathy at baseline were excluded .
-RESULTS	No significant differences were found in individual nerve conduction measures .
-RESULTS	No treatment exceeded the prespecified clinically important decrease in IENF .
-RESULTS	Tanezumab resulted in significant improvement in pain , physical function , and Patient 's Global Assessment .
-RESULTS	Safety was similar to previous tanezumab clinical trials .
-CONCLUSIONS	Tanezumab has a modulating effect on pain , does not appear to increase neurological safety signals , and offers a potentially promising , novel approach in treatment of pain .
-
-###25338241
-OBJECTIVE	To evaluate the safety of the performance of the traditional and protected collection techniques of tracheal aspirate and to identify qualitative and quantitative agreement of the results of microbiological cultures between the techniques .
-METHODS	Clinical , prospective , comparative , single-blind research .
-METHODS	The sample was composed of 54 patients of > 18 years of age , undergoing invasive mechanical ventilation for a period of 48 hours and with suspected Ventilator Associated Pneumonia .
-METHODS	The two techniques were implemented in the same patient , one immediately after the other , with an order of random execution , according to randomization by specialized software .
-RESULTS	No significant events occurred oxygen desaturation , hemodynamic instability or tracheobronchial hemorrhage ( p < 0.05 ) and , although there were differences in some strains , there was qualitative and quantitative agreement between the techniques ( p < 0.001 ) .
-CONCLUSIONS	Utilization of the protected technique provided no advantage over the traditional and execution of both techniques was safe for the patient .
-
-###25992536
-BACKGROUND	The spot urine protein/creatinine ratio ( UPCR ) is proposed to be a substitute for 24-hour urinary protein ( 24h-UP ) .
-BACKGROUND	This study is aimed to determine whether the predictive accuracy of 24h-UP using UPCR can be improved by simply multiplying estimated daily urine creatinine excretion ( eUCr ) and UPCR together .
-METHODS	This study enrolled 120 participants to investigate the correlation between spot UPCR and 24h-UP .
-METHODS	Three sets of spot urine samples were randomly collected throughout the day and night , along with the first morning void .
-METHODS	UPCR was weighted by eUCr to investigate the improvement of accuracy in using spot urine samples to predict 24h-UP .
-RESULTS	There were strong correlation and concordance between UPCR and 24h-UP irrespective of the time of spot urine sampling , and the correlation , concordance and agreement were improved after multiplying the UPCR value by the eUCr .
-RESULTS	Greater improvement was found in the subgroups with measured daily urine creatinine excretion 0.8 g/d and 1.2 g/d .
-CONCLUSIONS	This investigation demonstrated that multiplying UPCR by eUCr can improve the accuracy of only using UPCR to predict 24h-UP .
-
-###24832000
-BACKGROUND	Malignant pleural effusion is associated with short life expectancy and significant morbidity .
-BACKGROUND	A randomized controlled trial comparing indwelling pleural catheters ( IPCs ) with talc pleurodesis found that IPCs reduced in-hospital time and the need for additional procedures but were associated with excess adverse events .
-METHODS	Using data from the clinical trial , we compared costs associated with use of IPCs and with talc pleurodesis .
-METHODS	Resource use and adverse events were captured through case report forms over the 1-year trial follow-up .
-METHODS	Costs for outpatient and inpatient visits , diagnostic imaging , nursing , and doctor time were obtained from the UK National Health Service reference costs and University of Kent 's Unit Costs of Health and Social Care 2011 and inflated to 2013 using the UK Consumer Price Index .
-METHODS	Procedure supply costs were obtained from the manufacturer .
-METHODS	Difference in mean costs was compared using nonparametric bootstrapping .
-METHODS	All costs were converted to US dollars using the Organisation for Economic Co-operation and Development Purchasing Power Parity Index .
-RESULTS	Overall mean cost ( SD ) for managing patients with IPCs and talc pleurodesis was $ 4,993 ( $ 5,529 ) and $ 4,581 ( $ 4,359 ) , respectively .
-RESULTS	The incremental mean cost difference was $ 401 , with 95 % CI of - $ 1,387 to $ 2,261 .
-RESULTS	The mean cost related to ongoing drainage in the IPC group was $ 1,011 ( $ 732 ) vs $ 57 ( $ 213 ) in the talc pleurodesis group ( P = .001 ) .
-RESULTS	This included the cost of drainage bottles , dressing changes in the first month , and catheter removal .
-RESULTS	There was no significant difference in cost of the initial intervention or adverse events between the groups .
-RESULTS	For patients with survival < 14 weeks , IPC is significantly less costly than talc pleurodesis , with mean cost difference of - $ 1,719 ( 95 % CI , - $ 3,376 to - $ 85 ) .
-CONCLUSIONS	There is no significant difference in the mean cost of managing patients with IPCs compared with talc pleurodesis .
-CONCLUSIONS	For patients with limited survival , IPC appears less costly .
-BACKGROUND	isrctn.org ; No. : ISRCTN87514420 ; URL : www.isrctn.org .
-
-###24815795
-BACKGROUND	In pulmonary arterial hypertension ( PAH ) , adding oral sildenafil to intravenous epoprostenol improved 6-minute walk distance ( 6MWD ) and hemodynamics and delayed time to clinical worsening in a 16-week randomized , placebo-controlled trial ( Pulmonary Arterial Hypertension Combination Study of Epoprostenol and Sildenafil [ PACES-1 ] ) .
-METHODS	Patients completing PACES-1 could receive sildenafil ( titrated to 80 mg , three times daily , as tolerated ) in an open-label extension study ( PACES-2 ) for 3 years ; additional therapy was added according to investigator judgment .
-METHODS	Survival and changes from PACES-1 baseline in World Health Organization Functional Class and 6MWD were captured .
-RESULTS	In an open-label setting , 6MWD , an effort-dependent outcome measure , was known to have improved or to have been maintained in 59 % , 44 % , and 33 % of patients at 1 , 2 , and 3 years , respectively ; functional class was known to have improved or to have been maintained in 73 % , 59 % , and 46 % .
-RESULTS	At 3 years , 66 % of patients were known to be alive , 24 % were known to have died , and 10 % were lost to follow-up .
-RESULTS	Patients with PACES-1 baseline 6MWD < 325 meters without 6MWD improvement during the first 20 weeks of sildenafil treatment subsequently had poorer survival .
-CONCLUSIONS	Although reliable assessments of safety and efficacy require a long-term randomized trial , the addition of sildenafil to background intravenous epoprostenol therapy appeared generally to be well tolerated in PAH patients .
-
-###24474302
-OBJECTIVE	Erlotinib , N - ( 3-ethynylphenyl ) -6,7 - bis ( 2-methoxyethoxy ) quinazolin-4-amine is approved for the treatment for non-small cell lung cancer and pancreatic cancer .
-OBJECTIVE	Because erlotinib is metabolized predominately by CYP3A4 , co-administration of compounds that increase CYP3A4 activity may alter the efficacy and safety of erlotinib therapy .
-OBJECTIVE	Two phase I studies were conducted in healthy male subjects to evaluate the effect of pre - or co-administered rifampicin , a CYP3A4 inducer , on the pharmacokinetics of erlotinib .
-METHODS	Study 1 included Groups A ( erlotinib 150 mg days 1 and 15 , rifampicin 600 mg days 8-14 ) and B ( erlotinib 150 mg days 1 and 15 ) in a parallel group study design .
-METHODS	Study 2 subjects received erlotinib 150 mg day 1 , erlotinib 450 mg day 15 , and rifampicin 600 mg days 8-18 .
-METHODS	The primary endpoint in each study was the ratio of exposure ( AUC0 - and C max ) between days 1 and 15 .
-METHODS	Urinary cortisol metabolic induction ratios were determined in Study 1 for Group A subjects only .
-RESULTS	In Study 1 , the geometric mean ratios of AUC0 - and C max were 33 and 71 % , respectively , and the mean cortisol metabolic index increased from 7.4 to 27.0 , suggesting cytochrome P450 ( CYP ) enzyme induction .
-RESULTS	In Study 2 , the geometric mean ratios for AUC0 - and C max were 19 and 34 % ( when dose adjusted from 450 to 150 mg erlotinib ) , respectively , a greater relative decrease than observed in Study 1 .
-CONCLUSIONS	Erlotinib exposure ( AUC0 - and C max ) was reduced after pre - or concomitant dosing with rifampicin .
-CONCLUSIONS	Doses of 450 mg erlotinib may be necessary to compensate for concomitant medications with strong CYP3A4 enzyme induction effect .
-
-###25878306
-BACKGROUND	Radiostereometric analysis provides highly precise measurements of component micromotion relative to the bone that is otherwise undetectable by routine radiographs .
-BACKGROUND	This study compared , at a minimum of five years following surgery , the micromotion of tantalum and titanium acetabular cups and femoral head penetration in highly cross-linked polyethylene liners and conventional ( ultra-high molecular weight polyethylene ) liners in active patients who had undergone total hip replacement .
-METHODS	This institutional review board-approved prospective , randomized , blinded study involved forty-six patients .
-METHODS	Patients were randomized into one of four cohorts according to both acetabular cup and polyethylene liner .
-METHODS	Patients received either a cementless cup with a titanium mesh surface or a tantalum trabecular surface and either a highly cross-linked polyethylene liner or an ultra-high molecular weight polyethylene liner .
-METHODS	Radiostereometric analysis examinations and Short Form-36 Physical Component Summary , Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) , University of California Los Angeles ( UCLA ) activity , and Harris hip scores were obtained preoperatively , postoperatively , at six months , and annually thereafter .
-RESULTS	All patients had significant improvement ( p < 0.05 ) in Short Form-36 Physical Component Summary , WOMAC , UCLA activity , and Harris hip scores postoperatively .
-RESULTS	On radiostereometric analysis examination , highly cross-linked polyethylene liners showed significantly less median femoral head penetration at five years ( p < 0.05 ) .
-RESULTS	Steady-state wear rates from one year to five years were 0.04 mm per year for ultra-high molecular weight polyethylene liners and 0.004 mm per year for highly cross-linked polyethylene liners .
-RESULTS	At the five-year follow-up , the median migration ( and standard error ) was 0.05 0.20 mm proximally for titanium cups and 0.21 0.05 mm for tantalum cups .
-CONCLUSIONS	In this young population who had undergone total hip replacement , radiostereometric analysis showed significantly less femoral head penetration in the highly cross-linked polyethylene liners compared with that in the conventional ultra-high molecular weight polyethylene liners .
-CONCLUSIONS	Penetration rates were one order of magnitude less in highly cross-linked polyethylene liners compared with ultra-high molecular weight polyethylene liners .
-CONCLUSIONS	There was no significant difference in proximal migration between the tantalum and titanium acetabular cups through the five-year follow-up ( p > 0.19 ) .
-
-###26026737
-BACKGROUND	Inactivity and sedentary behavior are related to poorer health outcomes in breast cancer survivors .
-BACKGROUND	However , few studies examining these behaviors in survivors have used objective measures , considered activities other than moderate-to-vigorous intensity activity ( MVPA ) and/or sedentary behavior ( i.e. low intensity activities ) or compared survivors to healthy controls .
-BACKGROUND	The purpose of the present study is to compare accelerometer-measured activity of various intensities ( total , light , lifestyle , MVPA ) and sedentary behavior between breast cancer survivors and non-cancer controls .
-METHODS	An imputation-based approach of independent sample t-tests adjusting for multiple comparisons was used to compare estimates of participation in each activity and sedentary behavior between survivors [ n = 398 ; M ( SD ) age = 56.95 ( 9.11 ) ] and block-matched non-cancer controls [ n = 1120 ; M ( SD ) age = 54.88 ( 16.11 ) ] .
-METHODS	Potential moderating effects of body mass index ( BMI ) , age , and education were also examined .
-RESULTS	Breast cancer survivors registered less daily total ( 282.8 v. 346.9 ) light ( 199.1 v. 259.3 ) and lifestyle ( 62.0 v. 71.7 ) activity minutes and more MVPA ( 21.6 v. 15.9 ) and sedentary behavior ( 555.7 v. 500.6 ) minutes than controls ( p < 0.001 for all ) .
-RESULTS	These relationships were largely consistent across BMI , age and education .
-RESULTS	On average , survivors spent an estimated 66.4 % of their waking time sedentary and 31.1 % in light/lifestyle activity and 2.6 % in MVPA .
-CONCLUSIONS	Breast cancer survivors are more sedentary and participate in less low intensity activity than controls .
-CONCLUSIONS	Although survivors registered more MVPA , these levels were insufficient .
-CONCLUSIONS	Future research should explore these differences and potential benefits of targeting low intensity activities and reducing sedentary time in this population .
-
-###24804638
-BACKGROUND	Scarring represents a significant biomedical burden in clinical medicine .
-BACKGROUND	Mechanomodulation has been linked to scarring through inflammation , but until now a systematic approach to attenuate mechanical force and reduce scarring has not been possible .
-METHODS	The authors conducted a 12-month , prospective , open-label , randomized , multicenter clinical trial to evaluate abdominoplasty scar appearance following postoperative treatment with the embrace Advanced Scar Therapy device to reduce mechanical forces on healing surgical incisions .
-METHODS	Incisions from 65 healthy adult subjects were randomized to receive embrace treatment on one half of an abdominoplasty incision and control treatment ( surgeon 's optimal care methods ) on the other half .
-METHODS	The primary endpoint for this study was the difference between assessments of scar appearance for the treated and control sides using the visual analogue scale scar score .
-RESULTS	Final 12-month study photographs were obtained from 36 subjects who completed at least 5 weeks of dressing application .
-RESULTS	The mean visual analogue scale score for embrace-treated scars ( 2.90 ) was significantly improved compared with control-treated scars ( 3.29 ) at 12 months ( difference , 0.39 ; 95 percent confidence interval , 0.14 to 0.66 ; p = 0.027 ) .
-RESULTS	Both subjects and investigators found that embrace-treated scars demonstrated significant improvements in overall appearance at 12 months using the Patient and Observer Scar Assessment Scale evaluation ( p = 0.02 and p < 0.001 , respectively ) .
-RESULTS	No serious adverse events were reported .
-CONCLUSIONS	These results demonstrate that the embrace device significantly reduces scarring following abdominoplasty surgery .
-CONCLUSIONS	To the authors ' knowledge , this represents the first level I evidence for postoperative scar reduction .
-METHODS	Therapeutic , II .
-
-###24297318
-BACKGROUND	Peritoneal dialysis ( PD ) requires patients to take an active role in their adherence to fluid restrictions .
-BACKGROUND	Although fluid non-adherence had been identified among this patient group , no specific interventions have been researched or published with in the PD population .
-BACKGROUND	The current study sought to investigate whether an applied cognitive behavioural therapy ( CBT-based intervention ) used among haemodialysis patients would improve fluid adherence among PD patients ; utilizing clinical indicators used in practice .
-METHODS	Fifteen PD patients identified as fluid non-adherent were randomly assigned to an intervention group ( IG ) or a deferred-entry control group ( CG ) .
-METHODS	The study ran for a total of 21 weeks , with five data collection points ; at baseline , post-intervention and at three follow-up points ; providing a RCT phase and a combined longitudinal analysis phase .
-METHODS	The content of the group intervention encompassed educational , cognitive and behavioural components , aimed to assist patients ' self-management of fluid .
-RESULTS	No significant differences in weight ( kg ) reduction were found in either phase and undesirable changes in blood pressure ( BP ) were observed .
-RESULTS	However , in the longitudinal phase , a statistically significant difference in oedematous status was observed at 6-week follow-up ; which may be indicative of fluid adherence .
-RESULTS	Positive and significant differences were observed in the desired direction for measures of psychological well-being , quality of life and health beliefs ; areas correlated with enhanced fluid adherence in other research .
-CONCLUSIONS	This study reveals encouraging and significant changes in predictors of fluid adherence .
-CONCLUSIONS	Although there were no significant changes in weight as a crude clinical measure of fluid intake , significant reductions in oedematous status were observed as a consequence of this CBT-based group intervention .
-
-###25127659
-BACKGROUND	This study compared palonosetron and ondansetron as rescue medications for postoperative nausea and vomiting ( PONV ) in patients who received prophylactic ondansetron .
-BACKGROUND	Although guidelines recommend use of an agent from a different class when prophylaxis has failed , palonosetron has unique properties relative to other serotonin 5-HT3 receptor antagonists .
-BACKGROUND	Prior trials assessing its use for rescue have had conflicting results .
-BACKGROUND	Although palonosetron has compared favorably with ondansetron for PONV prevention , the drugs have not been compared in the rescue setting of failure of 5-HT3 receptor antagonist prophylaxis .
-METHODS	This was a randomized , open-label , multicenter trial comparing the efficacy and safety of intravenous palonosetron 0.075 mg and intravenous ondansetron 4mg in patients experiencing PONV following laparoscopic abdominal or gynecological surgery despite prophylactic ondansetron .
-RESULTS	Of 239 patients screened , 220 were enrolled and 98 were treated for PONV : 48 and 50 in the palonosetron and ondansetron arms , respectively .
-RESULTS	Complete control during 72hours after study drug administration was achieved in 25.0 % of palonosetron recipients and 18.0 % of ondansetron recipients ( 95 % confidence interval [ CI ] , -9.2 , 23.3 ; p = 0.40 ) .
-RESULTS	Corresponding incidences of vomiting were 29.2 % for palonosetron and 48.0 % for ondansetron ( 95 % CI , -0.06 , 37.7 ; p = 0.057 ) , and 62.5 % and 56.0 % required additional rescue treatment , respectively ( 95 % CI , -25.9 , 12.9 ; p = 0.52 ) .
-RESULTS	Other than a similar incidence of procedural pain in the 2 groups , the most common treatment-emergent adverse events , which were generally mild , were headache ( 14.6 % vs 12.0 % ) , constipation ( 8.3 % vs 10.0 % ) , and dizziness ( 6.3 % vs 8.0 % ) , for the palonosetron and ondansetron groups , respectively .
-CONCLUSIONS	Palonosetron and ondansetron did not show differences in the primary efficacy endpoint of CC during the 72hours after study drug administration .
-CONCLUSIONS	There was a trend toward less emesis in the 0-72h time period favoring palonosetron .
-CONCLUSIONS	While larger studies are needed to fully assess any clinical benefits of palonosetron to rescue patients who have failed ondansetron prophylaxis for PONV , the benefit , if any , would be limited based on this study .
-BACKGROUND	ClinicalTrials.gov , NCT00967499 ( Registered August 27 , 2009 ) .
-
-###25573393
-BACKGROUND	Current methods of the transtibial pull-out meniscal root repair significantly displace under cyclic loading in porcine models but have not been evaluated in human models .
-BACKGROUND	One potential explanation for the displacement is that a single transtibial tunnel may not fully restore the attachment of the entire posterior medial meniscal root .
-OBJECTIVE	The purpose of this study was to biomechanically evaluate the transtibial pull-out technique in a human cadaveric model using either 1 or 2 transtibial bone tunnels .
-OBJECTIVE	The hypothesis was that a transtibial pull-out technique using 2 transtibial bone tunnels would confer superior biomechanical properties in comparison to an iteration using 1 transtibial bone tunnel .
-METHODS	Controlled laboratory study .
-METHODS	Ten matched pairs of male human cadaveric knees ( average age , 52.7 years ) were randomly assigned ( 1 each of the pair ) to 2 groups consisting of a transtibial pull-out technique using either 1 or 2 transtibial bone tunnels .
-METHODS	The knees were cyclically loaded for 1000 cycles from 10 to 30 N at 0.5 Hz , representing the loads experienced during a typical meniscal root repair postoperative rehabilitation program , and then pulled to failure at a rate of 0.5 mm/s .
-RESULTS	Differences between 1 - and 2-tunnel repair groups were neither statistically nor clinically significant with respect to displacement or ultimate failure load .
-RESULTS	On average , the 1 - and 2-tunnel repair groups resulted in 3.32 mm and 3.23 mm of displacement , respectively , after 1000 testing cycles .
-RESULTS	At 1 , 100 , 500 , and 1000 testing cycles , displacement was not significantly different between groups ( P > .799 ) .
-RESULTS	The 2-tunnel repair technique resulted in a 10.2 % higher ultimate failure load ( 135 N vs. 123 N ) ; however , this was not significant ( P = .333 ) .
-CONCLUSIONS	Similar biomechanical properties were seen between transtibial pull-out repairs using either 1 or 2 transtibial bone tunnels in a human cadaveric model .
-CONCLUSIONS	Both repair groups exceeded the 3-mm threshold for nonanatomic displacement .
-CONCLUSIONS	This study indicates that a newly proposed iteration of the transtibial pull-out repair technique using a second transtibial tunnel , which theoretically restores more of the posterior medial meniscal root , was almost identical to the current clinical standard involving a single transtibial tunnel .
-CONCLUSIONS	As the importance of repairing meniscal root tears is increasingly recognized , further studies on new iterations of both techniques are warranted to minimize the risk of displacement caused by early motion in the initial postoperative rehabilitation period .
-
-###25397817
-BACKGROUND	Several evidence-based treatments are available to veterans diagnosed with posttraumatic stress disorder ( PTSD ) .
-BACKGROUND	However , not all veterans benefit from these treatments or prefer to engage in them .
-OBJECTIVE	The current study explored whether ( 1 ) a mantram repetition program ( MRP ) increased mindful attention among veterans with PTSD , ( 2 ) mindful attention mediated reduced PTSD symptom severity and enhanced psychological well-being , and ( 3 ) improvement in mindful attention was due to the frequency of mantram repetition practice .
-METHODS	Data from a randomized controlled trial comparing MRP plus treatment as usual ( MRP+TAU ) or TAU were analyzed using hierarchical linear models .
-METHODS	A total of 146 veterans with PTSD from military-related trauma were recruited from a Veterans Affairs outpatient PTSD clinic ( 71 MRP+TAU ; 75 TAU ) .
-METHODS	The Clinician Administered PTSD Scale ( CAPS ) , PTSD Checklist ( PCL ) , the Brief Symptom Inventory-18 depression subscale , Health Survey SF-12v2 , and Mindfulness Attention Awareness Scale ( MAAS ) were used .
-METHODS	Frequency of mantram repetition practice was measured using wrist-worn counters and daily logs .
-RESULTS	Intent-to-treat analyses indicated greater increases in mindful attention , as measured by the MAAS , for MRP+TAU as compared with TAU participants ( P < 0.01 ) .
-RESULTS	Mindful attention gains mediated previously reported treatment effects on reduced PTSD symptoms ( using both CAPS and PCL ) , reduced depression , and improved psychological well-being .
-RESULTS	Frequency of mantram repetition practice in turn mediated increased mindful attention .
-CONCLUSIONS	The MRP intervention and specifically , mantram practice , improved mindful attention in veterans with PTSD , yielding improved overall psychological well-being .
-CONCLUSIONS	MRP may be a beneficial adjunct to usual care in veterans with PTSD .
-
-###24974051
-BACKGROUND	ODM-201 is a novel androgen receptor ( AR ) inhibitor designed to block the growth of prostate cancer cells through high-affinity binding to the AR and inhibition of AR nuclear translocation .
-BACKGROUND	This trial assessed ODM-201 's safety , pharmacokinetics , and activity in men with metastatic castration-resistant prostate cancer .
-METHODS	The ARADES trial is an open-label phase 1-2 trial undertaken in 23 hospitals across Europe and USA with ongoing long-term follow-up .
-METHODS	Men with progressive metastatic castration-resistant prostate cancer , who had castrate concentrations of testosterone and an Eastern Cooperative Oncology Group score of 0-1 were enrolled .
-METHODS	In the phase 1 part of the trial , patients were given oral ODM-201 at a starting daily dose of 200 mg , which was increased to 400 mg , 600 mg , 1000 mg , 1400 mg , and 1800 mg .
-METHODS	In phase 2 , patients were randomly assigned centrally and stratified by previous chemotherapy and treatment with CPY17 inhibitors , to receive one of three daily doses of ODM-201 ( 200 mg , 400 mg , and 1400 mg ) .
-METHODS	The primary endpoint in phase 1 was safety and tolerability , whereas in phase 2 it was the proportion of patients with a PSA response ( 50 % or greater decrease in serum PSA ) at week 12 .
-METHODS	All analyses included patients who had received at least one dose of ODM-201 .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT01317641 , and NCT01429064 for the follow-up after 12 weeks .
-RESULTS	We enrolled patients between April 5 , 2011 , and March 12 , 2013 .
-RESULTS	In phase 1 , 24 patients were enrolled to six sequential cohorts of three to six patients and received a daily dose of ODM-201 , 200-1800 mg .
-RESULTS	No dose-limiting toxic effects were reported and the maximum tolerated dose was not reached .
-RESULTS	In phase 1 , three patients reported eight adverse events of grade 3 ( fracture , muscle injury , laceration , paralytic ileus , pain , presyncope , urinary retention , and vomiting ) and one patient had a grade 4 adverse event ( lymphoedema ) .
-RESULTS	None of the grade 3-4 adverse events were deemed to be related to ODM-201 .
-RESULTS	Of the phase 1 patients , the four who received 200 mg , seven who received 400 mg , and three who received 1400 mg entered the phase 2 part of the trial .
-RESULTS	In addition to these patients , 110 were randomly assigned to three groups : 200 mg ( n = 38 ) , 400 mg ( n = 37 ) , and 1400 mg ( n = 35 ) .
-RESULTS	For these patients , the most common treatment-emergent adverse events were fatigue or asthenia ( 15 [ 12 % ] of 124 patients ) , hot flush ( six [ 5 % ] ) , and decreased appetite ( five [ 4 % ] ) .
-RESULTS	One patient ( < 1 % ) had a grade 3 treatment-emergent adverse event ( fatigue ) ; no patients had a treatment-emergent grade 4 adverse event .
-RESULTS	38 patients who received 200 mg , 39 who received 400 mg , and 33 who received 1400 mg were assessable for PSA response at 12 weeks .
-RESULTS	11 ( 29 % ) patients in the 200 mg group , 13 ( 33 % ) in the 400 mg group , and 11 ( 33 % ) in the 1400 mg group had a PSA response at 12 weeks .
-CONCLUSIONS	Our results suggest that ODM-201 monotherapy in men with progressive metastatic castration-resistant prostate cancer provides disease suppression and that ODM-201 has a favourable safety profile .
-CONCLUSIONS	These findings support further investigation of clinical responses with ODM-201 in men with castration-resistant prostate cancer .
-BACKGROUND	Orion Corporation Orion Pharma , Endo Pharmaceuticals Inc. .
-
-###24553356
-BACKGROUND	The United Kingdom Employment Retention and Advancement ( U.K. ERA ) demonstration was the largest and most comprehensive social experiment ever conducted in the United Kingdom .
-BACKGROUND	It examined the extent to which a combination of postemployment advisory support and financial incentives could help lone parents on welfare to find sustained employment with prospects for advancement .
-BACKGROUND	ERA was experimentally tested across more than 50 public employment service offices and , within each office , individuals were randomly assigned to either a program ( or treatment ) group ( eligible for ERA ) or a control group ( not eligible ) .
-METHODS	This article presents the results of a multilevel nonexperimental analysis that examines the variation in office-level impacts and attempts to understand what services provided in the offices tend to be associated with impacts .
-RESULTS	The analysis suggests that impacts were greater in offices that emphasized in-work advancement , support while working and financial bonuses for sustained employment , and also in those offices that assigned more caseworkers to ERA participants .
-RESULTS	Offices that encouraged further education had smaller employment impacts .
-CONCLUSIONS	Plausible results are obtained identifying those particular implementation features that tended to be linked to stronger impacts of ERA .
-CONCLUSIONS	The methodology employed also allows the identification of which services are associated with employment and welfare receipt of control families receiving benefits under the traditional New Deal for Lone Parent program .
-
-###24816691
-BACKGROUND	Minimally invasive surgeries of the soft palate have emerged as a less-invasive treatment for habitual snoring .
-BACKGROUND	To date , there is only limited information available comparing the effects of snoring sound between different minimally invasive surgeries in the treatment of habitual snoring .
-OBJECTIVE	To compare the efficacy of palatal implant and radiofrequency surgery , in the reduction of snoring through subjective evaluation of snoring and objective snoring sound analysis .
-METHODS	Thirty patients with habitual snoring due to palatal obstruction ( apnea-hypopnea index 15 , body max index 30 ) were prospectively enrolled and randomized to undergo a single session of palatal implant or temperature-controlled radiofrequency surgery of the soft palate under local anesthesia .
-METHODS	Snoring was primarily evaluated by the patient with a 10 cm visual analogue scale ( VAS ) at baseline and at a 3-month follow-up visit and the change in VAS was the primary outcome .
-METHODS	Moreover , life qualities , measured by snore outcomes survey , and full-night snoring sounds , analyzed by a sound analytic program ( Snore Map ) , were also investigated at the same time .
-RESULTS	Twenty-eight patients completed the study ; 14 received palatal implant surgery and 14 underwent radiofrequency surgery .
-RESULTS	The VAS and snore outcomes survey scores were significantly improved in both groups .
-RESULTS	However , the good response ( postoperative VAS 3 or postoperative VAS 5 plus snore outcomes survey score 60 ) rate of the palatal implant group was significantly higher than that of the radiofrequency group ( 79 % vs. 29 % , P = 0.021 ) .
-RESULTS	The maximal loudness of low-frequency ( 40-300 Hz ) snores was reduced significantly in the palatal implant group .
-RESULTS	In addition , the snoring index was significantly reduced in the radiofrequency group .
-CONCLUSIONS	Both palatal implants and a single-stage radiofrequency surgery improve subjective snoring outcomes , but palatal implants have a greater effect on most measures of subjective and objective snoring .
-CONCLUSIONS	Multi-stage radiofrequency surgery was not tested .
-BACKGROUND	ClinicalTrials.gov NCT01955083 .
-
-###24793701
-OBJECTIVE	To investigate whether a maneuver for repeated cycles of collapse and reexpansion of the operative lung , termed `` intermittent reinflation '' ( IR ) , to counter hypoxemia during one-lung ventilation ( OLV ) , results in a time-dependent alteration of extravascular lung water .
-METHODS	Prospective , randomized clinical study .
-METHODS	Operating room and postsurgical intensive care unit of a university hospital .
-METHODS	36 ASA physical status 1 and 2 patients undergoing elective , video-assisted thoracic surgery for lung tumors .
-METHODS	Patients were randomly assigned to two groups .
-METHODS	Group C consisted of 18 patients whose nondependent lung was kept collapsed during OLV , while Group IR included 18 patients with IR that consisted of 4 separate , 10-second manual inflations and 5-second openings within one minute at intervals of 20 minutes during OLV .
-METHODS	Perioperative parameters included transcutaneous oxygen saturation ( SpO2 ) , hemodynamic data , extravascular lung water index ( EVLWI ) , pulmonary vascular permeability index ( PVPI ) as determined by the single-indicator transpulmonary thermodilution technique , and partial pressure of arterial oxygen/inspired oxygen fraction ( PaO2/FIO2 ) ratio .
-RESULTS	Group IR had significantly higher SpO2 at 20 minutes after commencement of OLV ( 98.9 % vs 96.3 % , P = 0.029 ) and average SpO2 throughout OLV ( 98.7 % vs 97.0 % , P = 0.020 ) .
-RESULTS	Hemodynamic data , EVLWI , PVPI , and PaO2/FIO2 ratio did not differ between the groups , and there were no differences between groups in postoperative morbidity or hospital stay .
-CONCLUSIONS	Intermittent reinflation had a beneficial effect on oxygenation during OLV , without any significant effects on EVLW or postoperative outcomes .
-
-###25284089
-OBJECTIVE	To report and discuss the multi-domain impact of elosulfase alfa , with focus on tertiary and composite endpoints , in the 24-week , randomized , double-blind , placebo-controlled phase 3 trial in patients with Morquio A syndrome ( mucopolysaccharidosis IVA ) .
-METHODS	Patients with Morquio A syndrome aged 5 years were randomized 1:1:1 to elosulfase alfa 2.0 mg/kg/week ( qw ; N = 58 ) , elosulfase alfa 2.0 mg/kg/every other week ( qow ; N = 59 ) , or placebo ( N = 59 ) for 24 weeks .
-METHODS	Primary and secondary efficacy measures were 6-minute walk test ( 6MWT ; primary ) , 3-minute stair climb test ( 3-MSCT ) and urinary keratan sulfate ( KS ) .
-METHODS	Safety was also evaluated .
-METHODS	Tertiary efficacy measures included respiratory function measures , activities of daily living ( MPS Health Assessment Questionnaire [ MPS-HAQ ] ) , anthropometric , echocardiographic and radiographic measures , hearing and corneal clouding assessment .
-METHODS	In order to fully characterize treatment impact in this heterogeneous disorder , the effect of elosulfase alfa on composite efficacy measures was evaluated as well .
-RESULTS	The study was not designed to have sufficient power for any of the tertiary outcomes .
-RESULTS	For most tertiary endpoints , subjects treated with the weekly dose of elosulfase alfa improved more than those receiving placebo .
-RESULTS	The largest treatment effects were seen in maximal voluntary ventilation ( MVV ) , MPS-HAQ , height , and growth rate .
-RESULTS	The qow group appeared similar to placebo .
-RESULTS	The analysis of a pre-specified composite endpoint ( combining changes from baseline in 6MWT , 3MSCT and MVV z-scores equally weighted ) showed a modest positive impact of elosulfase alfa qw versus placebo group ( P = 0.053 ) .
-RESULTS	As a pre-specified supportive analysis , the O'Brien Rank Sum composite endpoint ( changes from baseline in 6MWT , 3MSC , and MVV ) , analysis also showed that the qw group performed better than the placebo group ( P = 0.011 ) .
-RESULTS	In post-hoc analyses , combinations of other endpoints were also explored using the O'Brien Rank Sum test and showed statistically significant differences between elosulfase alfa qw and placebo favoring elosulfase alfa qw .
-RESULTS	Differences between elosulfase alfa qow and placebo were not statistically significant .
-RESULTS	Positive changes were observed in most tertiary variables , demonstrating the efficacy of weekly treatment with elosulfase alfa .
-CONCLUSIONS	Treatment with weekly elosulfase alfa led to improvements across most efficacy measures , resulting in clinically meaningful benefits in a heterogeneous study population .
-
-###24885600
-BACKGROUND	Acute myocardial infarction ( AMI ) is the leading cause of mortality worldwide .
-BACKGROUND	Oxidative stress has been involved in the ischemia-reperfusion injury in AMI .
-BACKGROUND	It has been suggested that reperfusion accounts for up to 50 % of the final size of a myocardial infarct , a part of the damage likely to be prevented.Therefore , we propose that antioxidant reinforcement through vitamins C and E supplementation should protect against the ischemia-reperfusion damage , thus decreasing infarct size.The PREVEC Trial ( Prevention of reperfusion damage associated with percutaneous coronary angioplasty following acute myocardial infarction ) seeks to evaluate whether antioxidant vitamins C and E reduce infarct size in patients subjected to percutaneous coronary angioplasty after AMI .
-METHODS	This is a randomized , 1:1 , double-blind , placebo-controlled clinical trial.The study takes place at two centers in Chile : University of Chile Clinical Hospital and San Borja Arriarn Clinical Hospital.The subjects will be 134 adults with acute myocardial infarction with indication for percutaneous coronary angioplasty.This intervention is being performed as a pilot study , involving high-dose vitamin C infusion plus oral administration of vitamin E ( Vitamin-treatment group ) or placebo ( Control group ) during the angioplasty procedure .
-METHODS	Afterward , the Vitamin-treatment group receives oral doses of vitamins C and E , and the Control group receives placebo for 84 days after coronary angioplasty.Primary outcome is infarct size , assessed by cardiac magnetic resonance ( CMR ) , measured 6 and 84 days after coronary angioplasty.Secondary outcomes are ejection fraction , measured 6 and 84 days after coronary angioplasty with CMR , and biomarkers for oxidative stress , antioxidant status , heart damage , and inflammation , which will be measured at baseline , at the onset of reperfusion , 6 to 8 hours after revascularization , and at hospital discharge .
-CONCLUSIONS	The ischemia-reperfusion event occurring during angioplasty is known to increase myocardial infarct size .
-CONCLUSIONS	The cardioprotective benefits of high doses of vitamin C combined with vitamin E have not been fully explored .
-CONCLUSIONS	The PREVEC Trial seeks to determine the suitability of the therapeutic use of vitamins C and E against the reperfusion damage produced during angioplasty.Patient recruitment opened in February 2013 .
-CONCLUSIONS	The trial is scheduled to end in March 2016 .
-BACKGROUND	ISRCTN56034553 .
-
-###24907062
-OBJECTIVE	To evaluate the safety and efficacy of dexamethasone intravitreal implant ( Ozurdex , DEX implant ) 0.7 and 0.35 mg in the treatment of patients with diabetic macular edema ( DME ) .
-METHODS	Two randomized , multicenter , masked , sham-controlled , phase III clinical trials with identical protocols were conducted .
-METHODS	Data were pooled for analysis .
-METHODS	Patients ( n = 1048 ) with DME , best-corrected visual acuity ( BCVA ) of 20/50 to 20/200 Snellen equivalent , and central retinal thickness ( CRT ) of 300 m by optical coherence tomography .
-METHODS	Patients were randomized in a 1:1:1 ratio to study treatment with DEX implant 0.7 mg , DEX implant 0.35 mg , or sham procedure and followed for 3 years ( or 39 months for patients treated at month 36 ) at 40 scheduled visits .
-METHODS	Patients who met retreatment eligibility criteria could be retreated no more often than every 6 months .
-METHODS	The predefined primary efficacy endpoint for the United States Food and Drug Administration was achievement of 15-letter improvement in BCVA from baseline at study end .
-METHODS	Safety measures included adverse events and intraocular pressure ( IOP ) .
-RESULTS	Mean number of treatments received over 3 years was 4.1 , 4.4 , and 3.3 with DEX implant 0.7 mg , DEX implant 0.35 mg , and sham , respectively .
-RESULTS	The percentage of patients with 15-letter improvement in BCVA from baseline at study end was greater with DEX implant 0.7 mg ( 22.2 % ) and DEX implant 0.35 mg ( 18.4 % ) than sham ( 12.0 % ; P 0.018 ) .
-RESULTS	Mean average reduction in CRT from baseline was greater with DEX implant 0.7 mg ( -111.6 m ) and DEX implant 0.35 mg ( -107.9 m ) than sham ( -41.9 m ; P < 0.001 ) .
-RESULTS	Rates of cataract-related adverse events in phakic eyes were 67.9 % , 64.1 % , and 20.4 % in the DEX implant 0.7 mg , DEX implant 0.35 mg , and sham groups , respectively .
-RESULTS	Increases in IOP were usually controlled with medication or no therapy ; only 2 patients ( 0.6 % ) in the DEX implant 0.7 mg group and 1 ( 0.3 % ) in the DEX implant 0.35 mg group required trabeculectomy .
-CONCLUSIONS	The DEX implant 0.7 mg and 0.35 mg met the primary efficacy endpoint for improvement in BCVA .
-CONCLUSIONS	The safety profile was acceptable and consistent with previous reports .
-
-###25854017
-OBJECTIVE	To explore the effects of early intervention of acupuncture on urinary function reconstruction of neurogenic bladder after spinal cord injury , so as to find the optimal treatment timing of acupuncture .
-METHODS	Fifty-three patients of neurogenic bladder after spinal cord injury were randomly divided into a prior-to-catheter group ( 25 cases ) and a posterior-to-catheter group ( 28 cases ) .
-METHODS	For the prior-to-catheter group , one week before the removal of catheter , acupoints on the abdomen and back such as Guanyuan ( CV 4 ) , Zhongji ( CV 3 ) , Baliao ( Shangliao ( BL 31 ) , Ciliao ( BL 32 ) , Zhongliao ( BL 33 ) , Xialiao ( BL 34 ) , Jiaji ( EX-B 2 ) and acupoints at distal end such as Zusanli ( ST 36 ) and Sanyinjiao ( SP 6 ) were selected ; after the catheter removal , simple method .
-METHODS	of water column was used to measure bladder capacity pressure to classify the type of bladder , and then different acupuncture manipulations were given ; intermittent catheterization was performed if condition was allowed .
-METHODS	The posterior-to-catheter group applied identical treatment after removal of catheter as the prior-to-catheter group .
-METHODS	The treatment was given 5 times per week ; after one-month treatment , five aspects including the time of first effective urination , time of establishing reflex urination , average residual volume of urine , time of residual urine less than 100 mL and quality of life ( QOL ) were evaluated .
-RESULTS	After treatment , the time of first effective urination , time of establishing reflex urination , average residual volume of urine and time of residual urineless than 100 mL in the prior-to-catheter group were all superior to those in the posterior-to-catheter group ( all P < 0.05 ) ; the score of QOL was improved in two groups after treatment ( both P < 0.01 ) , but the difference between two groups was not statistically significant ( P > 0.05 ) ; each index of urination function was not significant among patients with different injured segments of spinal cord ( all P > 0.05 ) .
-CONCLUSIONS	The early intervention of acupuncture ( prior to catheter ) has obvious improving function on establishing balanced bladder in patients with neurogenic bladder after spinal cord injury , which is superior to acupuncture intervention after removal of catheter , however , the effects of different injured segments on establishing balanced bladder are not different .
-
-###24289994
-OBJECTIVE	To identify a group of deliveries to mothers with indicators of subfertility ( SUBFERTILITY ) .
-METHODS	Longitudinal cohort study .
-METHODS	Hospital .
-METHODS	A total of 334,152 deliveries to Massachusetts mothers in a Massachusetts hospital between July 1 , 2004 , and December 31 , 2008 .
-METHODS	None .
-METHODS	Subfertility was defined by an indication on a current or past birth certificate or hospital utilization data of infertility or assisted reproductive technology ( ART ) cycle before index delivery and no indication of ART use with index delivery .
-RESULTS	Initially , 12,367 deliveries met the inclusion criteria for SUBFERTILITY ( 8,019 from birth certificates , 2,777 from hospital data , 1,571 from prior ART treatment ) .
-RESULTS	Removing deliveries from more than one data source resulted in 10,764 unique deliveries .
-RESULTS	Removing deliveries resulting from ART treatments left 6,238 deliveries in the SUBFERTILITY category .
-RESULTS	Demographic analysis indicated that deliveries in SUBFERTILITY were more similar to those in the ART population than to those in the fertile population .
-CONCLUSIONS	We have demonstrated the feasibility of using existing population-based linked public health data sets to identify SUBFERTILITY deliveries , and we have used ART data to distinguish ART and SUBFERTILITY births .
-CONCLUSIONS	The SUBFERTILITY category can serve as a comparison group of subfertile patients for studies of ART delivery and longitudinal health outcomes .
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-###24597472
-BACKGROUND	Idrabiotaparinux , a long-acting inhibitor of factor Xa , was shown to be effective in the treatment of patients with venous thromboembolism .
-OBJECTIVE	To assess non-inferiority for the efficacy of idrabiotaparinux versus warfarin in patients with atrial fibrillation ( AF ) at risk of stroke and systemic embolism .
-OBJECTIVE	Bleeding was also assessed .
-METHODS	This randomized , double-blind trial enrolled patients with electrocardiogram-documented AF .
-METHODS	Idrabiotaparinux was administered weekly via subcutaneous injection , and warfarin was administered daily with dose adjustment to maintain the international normalized ratio between 2.0 and 3.0 .
-METHODS	Each idrabiotaparinux injection was 3 mg for the first 7 weeks , followed by 2 mg thereafter , except in patients with a creatinine clearance of 30-50 mL min ( -1 ) or aged 75 years .
-METHODS	The patients received 1.5 mg after the first 7 weeks .
-METHODS	The efficacy outcome was the composite of all fatal or non-fatal strokes and systemic embolism .
-METHODS	The safety outcome was clinically relevant bleeding ( major and clinically relevant non-major bleeding ) .
-RESULTS	The study was terminated prematurely by the sponsor for strategic/commercial , not scientific , reasons , with 39 % of the planned number of patients included and an average duration of treatment of 240 days .
-RESULTS	Of the 1886 idrabiotaparinux recipients , 20 developed stroke or systemic embolism ( 1.5 % per year ) , whereas this occurred in 22 of the 1887 warfarin patients ( 1.6 % per year , hazard ratio 0.98 , 95 % confidence interval 0.49-1 .66 ) .
-RESULTS	The annual incidence of bleeding was 6.1 % in the idrabiotaparinux and 10.0 % in the warfarin group ( hazard ratio 0.61 , 95 % confidence interval 0.46-0 .81 ) .
-CONCLUSIONS	If anything , despite its early termination , the idrabiotaparinux regimen studied suggested a comparable efficacy to dose-adjusted warfarin , with a lower bleeding risk .
-
-###25350546
-BACKGROUND	Low rates of adherence to artemisinin-based combination therapy ( ACT ) regimens increase the risk of treatment failure and may lead to drug resistance , threatening the sustainability of current anti-malarial efforts .
-BACKGROUND	We assessed the impact of text message reminders on adherence to ACT regimens .
-METHODS	Health workers at hospitals , clinics , pharmacies , and other stationary ACT distributors in Tamale , Ghana provided flyers advertising free mobile health information to individuals receiving malaria treatment .
-METHODS	The messaging system automatically randomized self-enrolled individuals to the control group or the treatment group with equal probability ; those in the treatment group were further randomly assigned to receive a simple text message reminder or the simple reminder plus an additional statement about adherence in 12-hour intervals .
-METHODS	The main outcome was self-reported adherence based on follow-up interviews occurring three days after treatment initiation .
-METHODS	We estimated the impact of the messages on treatment completion using logistic regression .
-RESULTS	1140 individuals enrolled in both the study and the text reminder system .
-RESULTS	Among individuals in the control group , 61.5 % took the full course of treatment .
-RESULTS	The simple text message reminders increased the odds of adherence ( adjusted OR 1.45 , 95 % CI [ 1.03 to 2.04 ] , p-value 0.028 ) .
-RESULTS	Receiving an additional message did not result in a significant change in adherence ( adjusted OR 0.77 , 95 % CI [ 0.50 to 1.20 ] , p-value 0.252 ) .
-CONCLUSIONS	The results of this study suggest that a simple text message reminder can increase adherence to antimalarial treatment and that additional information included in messages does not have a significant impact on completion of ACT treatment .
-CONCLUSIONS	Further research is needed to develop the most effective text message content and frequency .
-BACKGROUND	ClinicalTrials.gov NCT01722734 .
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-###26072348
-OBJECTIVE	We sought to define normative visual field ( VF ) values for children using common clinical test protocols for kinetic and static perimetry .
-METHODS	Prospective , observational study .
-METHODS	We recruited 154 children aged 5 to 15 years without any ophthalmic condition that would affect the VF ( controls ) from pediatric clinics at Moorfields Eye Hospital .
-METHODS	Children performed perimetric assessments in a randomized order using Goldmann and Octopus kinetic perimetry , and Humphrey static perimetry ( Swedish Interactive Thresholding Algorithm [ SITA ] 24-2 FAST ) , in a single sitting , using standardized clinical protocols , with assessment by a single examiner .
-METHODS	Unreliable results ( assessed qualitatively ) were excluded from the normative data analysis .
-METHODS	Linear , piecewise , and quantile mixed-effects regression models were used .
-METHODS	We developed a method to display age-specific normative isopters graphically on a VF plot to aid interpretation .
-METHODS	Summary measures and graphical plots describing normative VF data for 3 common perimetric tests .
-RESULTS	Visual field area increased with age on testing with Goldmann isopters III4e , I4e , and I2e ( linear regression ; P < 0.001 ) and for Octopus isopters III4e and I4e ( linear regression ; P < 0.005 ) .
-RESULTS	Visual field development occurs predominately in the inferotemporal field .
-RESULTS	Humphrey mean deviation ( MD ) showed an increase of 0.3 decibels ( dB ; 95 % CI , 0.21-0 .40 ) MD per year up to 12 years of age , when adult MD values were reached and thereafter maintained .
-CONCLUSIONS	Visual field size and sensitivity increase with age in patterns that are specific to the perimetric approach used .
-CONCLUSIONS	These developmental changes should be accounted for when interpreting perimetric test results in children , particularly when monitoring change over time .
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-###25005346
-BACKGROUND	Guidelines for SPECT myocardial perfusion imaging ( MPI ) traditionally recommend a fixed tracer dose .
-BACKGROUND	Yet , clinical practice shows degraded image quality in heavier patients .
-BACKGROUND	The aim was to optimize and validate the tracer dose and scan time to obtain a constant image quality less dependent on patients ' physical characteristics .
-METHODS	125 patients underwent Cadmium Zinc Telluride ( CZT ) - SPECT stress MPI using a fixed Tc-99m-tetrofosmin tracer dose .
-METHODS	Image quality was scored by three physicians on a 4-point grading scale and related to the number of photon counts normalized to tracer dose and scan time .
-METHODS	Counts were correlated with various patient-specific parameters dealing with patient size and weight to find the best predicting parameter .
-METHODS	From these data , a formula to provide constant image quality was derived , and subsequently tested in 92 new patients .
-RESULTS	Degradation in image quality and photon counts was observed for heavier patients for all patients ' specific parameters ( P < .01 ) .
-RESULTS	We found body weight to be the best-predicting parameter for image quality and derived a new dose formula .
-RESULTS	After applying this new body weight-depended tracer dose and scan time in a new group , image quality was found to be constant ( P > .19 ) in all patients .
-CONCLUSIONS	Also in CZT SPECT image quality decreases with weight .
-CONCLUSIONS	The use of a tracer dose and scan time that depends linearly on patient 's body weight corrected for the varying image quality in CZT-SPECT MPI .
-CONCLUSIONS	This leads to better radiation exposure justification .
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-###24924991
-BACKGROUND	No randomised study has shown whether stratification of treatment by minimal residual disease ( MRD ) response improves outcome in children and young people with acute lymphoblastic leukaemia ( ALL ) .
-BACKGROUND	We assessed whether children and young people with clinical standard and intermediate-risk ALL who have persistent MRD at the end of induction therapy benefit from augmented post-remission therapy .
-METHODS	Between Oct 1 , 2003 , and June 30 , 2011 , we enrolled eligible patients aged 1-24 years and initially categorised them into clinical standard-risk , intermediate-risk , and high-risk groups on the basis of a combination of National Cancer Institute criteria , cytogenetics , and early morphological response to induction therapy .
-METHODS	Clinical standard-risk and intermediate-risk patients with MRD of 001 % or higher at day 29 of induction ( MRD high risk ) were randomly assigned ( 1:1 ) to standard therapy ( treatment regimens A and B ) or augmented post-remission therapy ( regimen C ) .
-METHODS	Compared with standard therapy , the augmented treatment regimen ( regimen C ) included an additional eight doses of pegylated asparaginase , 18 doses of vincristine , and escalated-dose intravenous methotrexate without folinic acid rescue during interim maintenance courses .
-METHODS	Computer randomisation was used for treatment allocation and was balanced for sex , age ( < 10 years vs 10 years ) , and white blood cell count at diagnosis ( < 5010 ( 9 ) / L vs 5010 ( 9 ) / L ) by minimisation .
-METHODS	Patients , clinicians , and data analysts were not masked to treatment allocation .
-METHODS	The primary outcomes were event-free survival and overall survival .
-METHODS	Analyses were by intention to treat .
-METHODS	This trial is registered with Current Controlled Trials , number ISRCTN07355119 .
-RESULTS	533 MRD high-risk patients were randomly assigned to receive standard ( n = 266 ) or augmented ( n = 267 ) post-remission therapy .
-RESULTS	After a median follow-up of 70 months ( IQR 52-91 ) , 5-year event-free survival was better in the augmented treatment group ( 896 % [ 95 % CI 859-933 ] ) than in the standard group ( 828 % [ 781-875 ] ; odds ratio [ OR ] 061 [ 95 % CI 039-098 ] , p = 004 ) .
-RESULTS	Overall survival at 5 years was numerically , but not significantly , higher in the augmented treatment group ( 929 % [ 95 % CI 898-960 ] ) than in the standard therapy group ( 889 % [ 850-928 ] ; OR 067 [ 95 % CI 038-117 ] , p = 016 ) .
-RESULTS	More adverse events occurred in the augmented treatment group than in the standard group ( asparaginase-related hypersensitivity in 18 [ 67 % ] in the augmented group vs two [ 08 % ] in the standard group and asparaginase-related pancreatitis in eight [ 30 % ] vs one [ 04 % ] ; intravenous methotrexate-related mucositis in 11 [ 41 % ] vs three [ 11 % ] and methotrexate-related stomatitis in 48 [ 180 % ] vs 12 [ 45 % ] ) .
-CONCLUSIONS	Our findings suggest that children and young people with acute lymphoblastic leukaemia and 001 % or more MRD at the end of remission induction therapy could benefit from augmented post-remission therapy .
-CONCLUSIONS	However , the asparaginase and intravenous methotrexate used in the augmented treatment regimen is associated with more adverse events than is the standard post-remission treatment regimen .
-BACKGROUND	Medical Research Council and Leukaemia and Lymphoma Research .
-
-###24571588
-BACKGROUND	Quantification of molecular cell processes is important for prognostication and treatment individualization of head and neck cancer ( HNC ) .
-BACKGROUND	However , individual tumor comparison can show discord in upregulation similarities when analyzing multiple biological mechanisms .
-BACKGROUND	Elaborate tumor characterization , integrating multiple pathways reflecting intrinsic and microenvironmental properties , may be beneficial to group most uniform tumors for treatment modification schemes .
-BACKGROUND	The goal of this study was to systematically analyze if immunohistochemical ( IHC ) assessment of molecular markers , involved in treatment resistance , and 18F-FDG PET parameters could accurately distinguish separate HNC tumors .
-METHODS	Several imaging parameters and texture features for 18F-FDG small-animal PET and immunohistochemical markers related to metabolism , hypoxia , proliferation and tumor blood perfusion were assessed within groups of BALB/c nu/nu mice xenografted with 14 human HNC models .
-METHODS	Classification methods were used to predict tumor line based on sets of parameters .
-RESULTS	We found that 18F-FDG PET could not differentiate between the tumor lines .
-RESULTS	On the contrary , combined IHC parameters could accurately allocate individual tumors to the correct model .
-RESULTS	From 9 analyzed IHC parameters , a cluster of 6 random parameters already classified 70.3 % correctly .
-RESULTS	Combining all PET/IHC characteristics resulted in the highest tumor line classification accuracy ( 81.0 % ; cross validation 82.0 % ) , which was just 2.2 % higher ( p = 5.210-32 ) than the performance of the IHC parameter/feature based model .
-CONCLUSIONS	With a select set of IHC markers representing cellular processes of metabolism , proliferation , hypoxia and perfusion , one can reliably distinguish between HNC tumor lines .
-CONCLUSIONS	Addition of 18F-FDG PET improves classification accuracy of IHC to a significant yet minor degree .
-CONCLUSIONS	These results may form a basis for development of tumor characterization models for treatment allocation purposes .
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-###25223462
-BACKGROUND	The EACH study assessed the efficacy of oxaliplatin , 5-fluorouracil , and leucovorin ( the FOLFOX4 regimen ) compared with doxorubicin alone in terms of overall survival ( OS ) , progression-free survival ( PFS ) , and safety in patients with advanced hepatocellular carcinoma ( HCC ) .
-BACKGROUND	We present the results of this study in Chinese patients .
-METHODS	In a multicenter , open-label , randomized , phase III study ( NCT00471965 ) , 371 patients ( 279 patients from the People 's Republic of China ) were randomized 1:1 to receive either FOLFOX4 or doxorubicin until disease progression , intolerable toxicity , death , or surgical resection .
-RESULTS	Baseline characteristics of the Chinese patients enrolled in the study were similar for the 2 treatment groups and in comparison with the whole EACH cohort .
-RESULTS	Median OS at the prespecified time point of treatment was 5.7 months with FOLFOX4 and 4.3 months with doxorubicin ( hazard ratio [ HR ] : 0.74 ; 95 % confidence interval [ CI ] :0.55 -0.98 ; p = .03 ) .
-RESULTS	At the end of the follow-up period , median OS was 5.9 months with FOLFOX4 and 4.3 months with doxorubicin ( HR : 0.75 ; 95 % CI :0.58 -0.98 ; p = .03 ) .
-RESULTS	Median PFS was 2.4 months and 1.7 months in the FOLFOX4 and doxorubicin groups , respectively ( HR : 0.55 ; 95 % CI :0.45 -0.78 ; p = .0002 ) .
-RESULTS	The response rate ( RR ) and disease control rate ( DCR ) were significantly higher in the FOLFOX4 group than in the doxorubicin group ( RR : 8.6 % vs. 1.4 % , p = .006 ; DCR : 47.1 % vs. 26.6 % , p = .0004 ) .
-RESULTS	Hematological toxicity was more frequently reported in the FOLFOX4 group .
-CONCLUSIONS	For Chinese HCC patients enrolled in the EACH study , FOLFOX4 significantly improved the RR and DCR and prolonged survival compared with doxorubicin .
-CONCLUSIONS	Systemic chemotherapy with oxaliplatin-based regimens may play an important role in the treatment of Chinese patients with advanced HCC .
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-###24843061
-OBJECTIVE	Children are vulnerable to diet inadequacies , which may affect immune function .
-OBJECTIVE	Our objective was to determine if a follow-up formula ( FUF ) containing DHA , the prebiotics PDX and GOS , and yeast - glucan affects incidence of respiratory infections and diarrheal disease in healthy children .
-METHODS	In a double-blind , randomized , controlled , prospective trial , 3-4 year old children were fed 3 servings per day of either a FUF with 25 mg DHA , 1.2 g PDX/GOS , and 8.7 mg yeast - glucan per serving or an unfortified , cow 's milk-based beverage ( control ) for 28 weeks .
-METHODS	Fecal and blood samples were collected to assess immune markers and iron/zinc status .
-METHODS	Incidence of acute respiratory infections ( ARI ) , diarrheal disease , and antibiotic treatment were obtained from medical records .
-RESULTS	The FUF group had fewer episodes and shorter duration of ARI ( mean days [ SE ] ; control = 4.3 [ 0.2 ] ; FUF = 3.5 [ 0.2 ] ; P = .007 ) , less antibiotic use ( n [ % ] ; control = 21 [ 14 % ] ; FUF = 8 [ 5 % ] ; P = .01 ) , and fewer missed days of day care due to illness .
-RESULTS	No diarrheal disease was diagnosed in either group .
-RESULTS	The FUF group had higher interleukin-10 and white blood cell count at the end of the study .
-RESULTS	There were no differences in hemoglobin , serum ferritin and zinc , or fecal secretory immunoglobulin A.
-CONCLUSIONS	Daily consumption of a FUF was associated with fewer episodes and shorter duration of ARI , as well as less antibiotic use .
-CONCLUSIONS	The children who consumed the FUF had increased interleukin-10 and white blood cells , suggesting an antiinflammatory mechanism and/or an increase of effector immune cells .
-
-###24998121
-BACKGROUND	In the PROTECT AF ( Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation ) trial that evaluated patients with nonvalvular atrial fibrillation ( NVAF ) , left atrial appendage ( LAA ) occlusion was noninferior to warfarin for stroke prevention , but a periprocedural safety hazard was identified .
-OBJECTIVE	The goal of this study was to assess the safety and efficacy of LAA occlusion for stroke prevention in patients with NVAF compared with long-term warfarin therapy .
-METHODS	This randomized trial further assessed the efficacy and safety of the Watchman device .
-METHODS	Patients with NVAF who had a CHADS2 ( congestive heart failure , hypertension , age > 75 years , diabetes mellitus , and previous stroke/transient ischemic attack ) score 2 or 1 and another risk factor were eligible .
-METHODS	Patients were randomly assigned ( in a 2:1 ratio ) to undergo LAA occlusion and subsequent discontinuation of warfarin ( intervention group , n = 269 ) or receive chronic warfarin therapy ( control group , n = 138 ) .
-METHODS	Two efficacy and 1 safety coprimary endpoints were assessed .
-RESULTS	At 18 months , the rate of the first coprimary efficacy endpoint ( composite of stroke , systemic embolism [ SE ] , and cardiovascular/unexplained death ) was 0.064 in the device group versus 0.063 in the control group ( rate ratio 1.07 [ 95 % credible interval ( CrI ) : 0.57 to 1.89 ] ) and did not achieve the prespecified criteria noninferiority ( upper boundary of 95 % CrI 1.75 ) .
-RESULTS	The rate for the second coprimary efficacy endpoint ( stroke or SE > 7 days ' postrandomization ) was 0.0253 versus 0.0200 ( risk difference 0.0053 [ 95 % CrI : -0.0190 to 0.0273 ] ) , achieving noninferiority .
-RESULTS	Early safety events occurred in 2.2 % of the Watchman arm , significantly lower than in PROTECT AF , satisfying the pre-specified safety performance goal .
-RESULTS	Using a broader , more inclusive definition of adverse effects , these still were lower in PREVAIL ( Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy ) trial than in PROTECT AF ( 4.2 % vs. 8.7 % ; p = 0.004 ) .
-RESULTS	Pericardial effusions requiring surgical repair decreased from 1.6 % to 0.4 % ( p = 0.027 ) , and those requiring pericardiocentesis decreased from 2.9 % to 1.5 % ( p = 0.36 ) , although the number of events was small .
-CONCLUSIONS	In this trial , LAA occlusion was noninferior to warfarin for ischemic stroke prevention or SE > 7 days ' post-procedure .
-CONCLUSIONS	Although noninferiority was not achieved for overall efficacy , event rates were low and numerically comparable in both arms .
-CONCLUSIONS	Procedural safety has significantly improved .
-CONCLUSIONS	This trial provides additional data that LAA occlusion is a reasonable alternative to warfarin therapy for stroke prevention in patients with NVAF who do not have an absolute contraindication to short-term warfarin therapy .
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-###25524481
-OBJECTIVE	To compare the clinical outcome and complications of high viscosity and low viscosity poly-methyl methacrylate bone cement PVP for severe OVCFs .
-METHODS	From December 2010 to December 2012 , 32 patients with severe OVCFs were randomly assigned to either group H using high viscosity cement ( n = 14 ) or group L using low viscosity cement ( n = 18 ) .
-METHODS	The clinical outcomes were assessed by the Visual Analog Scale ( VAS ) , Oswestry Disability Index ( ODI ) , Short Form-36 General Health Survey ( SF-36 ) , kyphosis Cobb 's angle , vertebral height , and complications .
-RESULTS	Significant improvement in the VAS , ODI , SF-36 scores , kyphosis Cobb 's angle , and vertebral height were noted in both the groups , and there were no significant differences between the two groups .
-RESULTS	Cement leakage was seen less in group H. Postoperative assessment using computed tomography identified cement leakage in 5 of 17 ( 29.4 % ) vertebrae in group H and in 15 of 22 ( 68.2 % ) vertebrae in group L ( P = 0.025 ) .
-CONCLUSIONS	The PVP using high viscosity bone cement can provide the same clinical outcome and fewer complications compared with PVP using low viscosity bone cement .
-
-###24456624
-BACKGROUND	Therapeutic vaccination is a promising novel approach to treat HIV-1 infected people by boosting or redirecting immune system to neutralize critical HIV-1 antigens whose biological effects are relevant in the context of viral pathogenesis .
-BACKGROUND	With the aim to induce neutralizing antibodies to the matrix protein p17 we have developed a peptide-based immunogen ( AT20-KLH ) and evaluated its safety and immunogenicity .
-METHODS	Twenty four asymptomatic HAART-treated HIV-1 + patients were enrolled in a phase I clinical study and were randomized to three groups : 2 groups were treated with five IM injection ( Arm A : 25g/inoculation ; Arm B : 100g/inoculation ) at day ( D ) D0 , D28 , D56 , D84 and D112 ; the control group ( Arm C ) were not injected .
-METHODS	Safety was assessed by monitoring local and systemic adverse events ( AEs ) , recorded till D168 .
-METHODS	Evaluation of immunogenicity was by titering antibodies at D0 , D35 , D56 , D63 , D84 , D91 , D112 , D140 and D168 using ELISA .
-RESULTS	In all , 105 local and systemic AEs were reported across the three groups .
-RESULTS	Most were mild and resolved without sequelae .
-RESULTS	Also the few unsolicited events , deemed unrelated to the study vaccines , caused no problems .
-RESULTS	No significant changes in the routine laboratory parameters , CD4 T-cell count or HIV-1 viremia were found .
-RESULTS	At the time of enrollment 23 out of 24 patients had no anti-AT20 antibodies , whereas 11 exhibited anti-p17 antibodies .
-RESULTS	Irrespective of the presence of preimmunization antibodies , all subjects developed high titers of anti-AT20 antibodies ( GM 9775 ) in response to both AT20-KLH doses .
-RESULTS	These antibodies were also capable of recognizing AT20 within the p17 framework .
-CONCLUSIONS	The AT20 peptide-based approach has allowed to redirect HAART-treated patients ' humoral responses toward a previously untargeted hotspot of functional activity .
-CONCLUSIONS	Overall , the tested AT20-KLH doses were safe and well tolerated , supporting further exploration of AT20-KLH as an HIV-1 therapeutic vaccine candidate .
-
-###26089332
-OBJECTIVE	Hypertensive patients with electrocardiographic left ventricular hypertrophy are at increased risk of all-cause and cardiovascular death .
-OBJECTIVE	Lowering blood pressure ( BP ) after stroke reduces the risk of recurrent stroke , but recent data suggest that lower systolic BP ( SBP ) measured 5 years after stroke is associated with increased mortality .
-OBJECTIVE	Whether lower SBP is associated with increased short-term mortality after stroke in hypertensive patients is unclear .
-METHODS	All-cause and cardiovascular mortality were examined in relation to average on-treatment SBP after stroke in 541 hypertensive patients with electrocardiographic left ventricular hypertrophy randomly assigned to losartan - or atenolol-based treatment who had new strokes during follow-up .
-METHODS	Patients with on-treatment SBP < 144 mm Hg ( lowest tertile ) and SBP > 157 ( highest tertile ) were compared with patients with average SBP between 144 and 157 .
-RESULTS	During 2.021.65 years mean follow-up after incident stroke , 170 patients ( 31.4 % ) died , 135 ( 25.0 % ) from cardiovascular causes .
-RESULTS	In multivariate Cox analyses , adjusting for significant univariate predictors of mortality , compared with average SBP between 144 and 157 , an average SBP < 144 was a significant predictor of all-cause ( hazard ratio , 1.81 ; 95 % confidence interval , 1.20-2 .73 ) and cardiovascular mortality ( hazard ratio , 1.60 ; 95 % confidence interval , 1.02-2 .54 ) , whereas patients who had an average SBP > 157 had no significant increased risk of death .
-CONCLUSIONS	Lower achieved SBP ( < 144 mm Hg ) is associated with a significantly increased risk of cardiovascular and all-cause mortality after initial stroke in hypertensive patients during short-term follow-up .
-CONCLUSIONS	Further study is required to determine ideal SBP goals after stroke .
-BACKGROUND	URL : http://clinicaltrials.gov/ .
-BACKGROUND	Unique identifier : NCT00338260 .
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-###25607118
-BACKGROUND	LifeWave Energy Enhancer ( LEE ) patches ( LifeWave Corp , San Diego , CA , USA ) on skin produce some changes that are consistent with increased energy production , but little is known about their effects on cortisol concentrations or the peripheral circulation .
-OBJECTIVE	The study intended to assess the effects of LEE patches on salivary cortisol , peripheral circulation , and psychological measures on healthy adults .
-METHODS	A double-blind , placebo-controlled , randomized pilot study was performed .
-METHODS	Measurements were made in the laboratory at Mind-Body-Science ( Tucson , AZ , USA ) .
-METHODS	Participants collected some of the saliva samples at work or home .
-METHODS	To obtain pilot data , 20 healthy individuals with no chronic conditions were recruited-5 males and 15 females-aged 30-69 y.
-METHODS	Participants completed baseline psychological questionnaires and provided saliva samples for hormonal analysis .
-METHODS	The next day , fingertip microvascular perfusion was measured , LEE or placebo patches were applied to participants ' wrists , and perfusion scans were repeated , first immediately after and then 10 min after application of the patch .
-METHODS	Saliva samples were collected , and questionnaires were completed .
-METHODS	Participants returned at noon and 4:00 PM for further scans , and at the end of that time , the patches were removed .
-METHODS	The protocol was repeated the following day using new patches .
-METHODS	The research team analyzed the saliva samples for levels of cortisol and measured the percentage changes in cutaneous microvascular perfusion .
-METHODS	The participants completed the energy visual analog scales ( eVASs ) and the Marlowe-Crowne Social Desirability survey .
-RESULTS	After the first patch application , the active group showed significantly higher cortisol concentrations than the placebo group , both at noon-2 .39 0.17 ng/mL vs 2.15 0.27 ( P = .0360 ) , respectively-and at 4:00 PM - 2.02 0.24 vs 1.67 0.31 ( P = .0155 ) , respectively .
-RESULTS	No consistent changes occurred in perfusion .
-RESULTS	The eVAS score decreased significantly compared with baseline in the placebo group but not in the active group .
-CONCLUSIONS	Cortisol concentrations and eVAS scores showed significant differences between groups , which is consistent with the patches increasing energy production , warranting further testing .
-
-###24968767
-BACKGROUND	Due to the availability of new devices , the use of ventricular assist devices ( VADs ) in children has been increasing ; however , patient selection and optimal timing of device implantation in this population remains uncertain .
-METHODS	A retrospective review of the United Network for Organ Sharing dataset identified 5,200 listings without mechanical circulatory support ( MCS ) for isolated pediatric heart transplant , 1995 to 2012 .
-METHODS	Patients were randomly divided into a derivation and validation cohort .
-METHODS	A multivariable logistic regression model predicting the likelihood of death or need for MCS within 60 days was built using the derivation cohort and tested in the validation cohort .
-METHODS	A simplified score ( PedsMCS score ) was developed and evaluated for accuracy .
-RESULTS	The predictive model consisted of variables present at listing ( age , albumin level , creatinine clearance , serum bilirubin , mechanical ventilation , and inotropic support ) .
-RESULTS	It had good predictive ability ( C statistic 0.7304 ) within the validation cohort .
-RESULTS	The simplified PedsMCS score was also predictive ( C statistic 0.7217 ) and there was a strong correlation between predicted and expected outcomes ( r = 0.91 , p < 0.0001 ) .
-RESULTS	Patients with PedsMCS score 16 or greater had a significantly higher risk of death or MCS within 2 months ( 36.6 % ) than those with low scores ( < 6 ) ( 1.5 % , p < 0.0001 ) .
-RESULTS	A single point increase in PedsMCS score was associated with a 16.7 % increase in the risk of death or MCS with 2 months ( p < 0.0001 ) .
-CONCLUSIONS	We have developed and validated a simplified score to predict the need for MCS based on risk factors present at listing .
-CONCLUSIONS	This will provide more accurate prognostication in children awaiting heart transplant , and may improve patient selection .
-
-###24958603
-OBJECTIVE	Not all hypertensive patients respond well to ACE inhibition .
-OBJECTIVE	Here we determined whether renin-angiotensin system ( RAS ) phenotyping , i.e. , the measurement of renin or ACE , can predict the individual response to RAS blockade , either chronically ( enalapril vs. enalapril + candesartan ) or acutely ( enalaprilhydrochlorothiazide , HCT ) .
-RESULTS	Chronic enalapril + candesartan induced larger renin rises , but did not lower blood pressure ( BP ) more than enalapril .
-RESULTS	Similar observations were made for enalapril + HCT vs. enalapril when given acutely .
-RESULTS	Baseline renin predicted the peak changes in BP chronically , but not acutely .
-RESULTS	Baseline ACE levels had no predictive value .
-RESULTS	Yet , after acute drug intake , the degree of ACE inhibition , like renin , did correlate with BP .
-RESULTS	Only the relationship with renin remained significant after chronic RAS blockade .
-RESULTS	Thus , a high degree of ACE inhibition and a steep renin rise associate with larger acute responses to enalapril .
-RESULTS	However , variation was large , ranging > 50mm Hg for a given degree of ACE inhibition or renin .
-RESULTS	The same was true for the relationships between renin and BP , and between baseline renin and the maximum reduction in BP in the chronic study .
-CONCLUSIONS	Our data do not support that RAS phenotyping will help to predict the individual BP response to RAS blockade .
-CONCLUSIONS	Notably , these conclusions were reached in a carefully characterized , homogenous population , and when taking into account the known fluctuations in renin that relate to gender , age , ethnicity , salt intake and diuretic treatment , it seems unlikely that a cut-off renin level can be defined that has predictive value .
-
-###25282285
-BACKGROUND	The main challenge in CT screening for lung cancer is the high prevalence of pulmonary nodules and the relatively low incidence of lung cancer .
-BACKGROUND	Management protocols use thresholds for nodule size and growth rate to determine which nodules require additional diagnostic procedures , but these should be based on individuals ' probabilities of developing lung cancer .
-BACKGROUND	In this prespecified analysis , using data from the NELSON CT screening trial , we aimed to quantify how nodule diameter , volume , and volume doubling time affect the probability of developing lung cancer within 2 years of a CT scan , and to propose and evaluate thresholds for management protocols .
-METHODS	Eligible participants in the NELSON trial were those aged 50-75 years , who have smoked 15 cigarettes or more per day for more than 25 years , or ten cigarettes or more for more than 30 years and were still smoking , or had stopped smoking less than 10 years ago .
-METHODS	Participants were randomly assigned to low-dose CT screening at increasing intervals , or no screening .
-METHODS	We included all participants assigned to the screening group who had attended at least one round of screening , and whose results were available from the national cancer registry database .
-METHODS	We calculated lung cancer probabilities , stratified by nodule diameter , volume , and volume doubling time and did logistic regression analysis using diameter , volume , volume doubling time , and multinodularity as potential predictor variables .
-METHODS	We assessed management strategies based on nodule threshold characteristics for specificity and sensitivity , and compared them to the American College of Chest Physicians ( ACCP ) guidelines .
-METHODS	The NELSON trial is registered at www.trialregister.nl , number ISRCTN63545820 .
-RESULTS	Volume , volume doubling time , and volumetry-based diameter of 9681 non-calcified nodules detected by CT screening in 7155 participants in the screening group of NELSON were used to quantify lung cancer probability .
-RESULTS	Lung cancer probability was low in participants with a nodule volume of 100 mm ( 3 ) or smaller ( 06 % [ 95 % CI 04-08 ] ) or maximum transverse diameter smaller than 5 mm ( 04 % [ 02-07 ] ) , and not significantly different from participants without nodules ( 04 % [ 03-06 ] , p = 017 and p = 100 , respectively ) .
-RESULTS	Lung cancer probability was intermediate ( requiring follow-up CT ) if nodules had a volume of 100-300 mm ( 3 ) ( 24 % [ 95 % CI 17-35 ] ) or a diameter 5-10 mm ( 13 % [ 10-18 ] ) .
-RESULTS	Volume doubling time further stratified the probabilities : 08 % ( 95 % CI 04-17 ) for volume doubling times 600 days or more , 40 % ( 18-83 ) for volume doubling times 400-600 days , and 99 % ( 69-141 ) for volume doubling times of 400 days or fewer .
-RESULTS	Lung cancer probability was high for participants with nodule volumes 300 mm ( 3 ) or bigger ( 169 % [ 95 % CI 141-200 ] ) or diameters 10 mm or bigger ( 152 % [ 127-181 ] ) .
-RESULTS	The simulated ACCP management protocol yielded a sensitivity and specificity of 909 % ( 95 % CI 812-961 ) , and 872 % ( 864-879 ) , respectively .
-RESULTS	A diameter-based protocol with volumetry-based nodule diameter yielded a higher sensitivity ( 924 % [ 95 % CI 831-971 ] ) , and a higher specificity ( 900 % [ 893-907 ) .
-RESULTS	A volume-based protocol ( with thresholds based on lung cancer probability ) yielded the same sensitivity as the ACCP protocol ( 909 % [ 95 % CI 812-961 ] ) , and a higher specificity ( 949 % [ 944-954 ] ) .
-CONCLUSIONS	Small nodules ( those with a volume < 100 mm ( 3 ) or diameter < 5 mm ) are not predictive for lung cancer .
-CONCLUSIONS	Immediate diagnostic evaluation is necessary for large nodules ( 300 mm ( 3 ) or 10 mm ) .
-CONCLUSIONS	Volume doubling time assessment is advocated only for intermediate-sized nodules ( with a volume ranging between 100-300 mm ( 3 ) or diameter of 5-10 mm ) .
-CONCLUSIONS	Nodule management protocols based on these thresholds performed better than the simulated ACCP nodule protocol .
-BACKGROUND	Zorgonderzoek Nederland Medische Wetenschappen and Koningin Wilhelmina Fonds .
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-###24249434
-BACKGROUND	The aim of this research was to compare the pharmacodynamics of the combination of mitiglinide and sitagliptin to that of each agent alone in Korean patients with type 2 diabetes mellitus ( T2DM ) .
-METHODS	Patients with T2DM received mitiglinide alone , sitagliptin alone , or both drugs together in randomized sequence .
-METHODS	A meal tolerance test ( MTT ) was conducted for each group , and plasma concentrations of glucose , insulin , C-peptide , glucagon , and intact glucagon-like peptide-1 , and dipeptidyl peptidase-4 activity were measured from 2 h before breakfast through 4 h after breakfast on day 0 ( pretreatment ) and day 1 ( posttreatment ) of each treatment period .
-METHODS	Integrated values of these pharmacodynamic variables were analyzed for changes from pretreatment to posttreatment and for differences between the three treatment groups .
-RESULTS	Twenty-six patients with glycated hemoglobin A1c level of 7.4 % 0.6 % , fasting plasma glucose concentration of 141 22 mg/dL , postprandial plasma glucose ( PPG ) concentration of 264 48 mg/dL 1 h after the MTT , and diabetes duration of 3.0 3.1 years ( mean SD ) were included in the study .
-RESULTS	Compared with mitiglinide or sitagliptin alone , the combination treatment lowered PPG additively ( P < 0.001 vs. mitiglinide or sitagliptin alone ) and the insulin secretory response ( P = 0.03 vs. mitiglinide or sitagliptin alone ) .
-RESULTS	The integrated insulin concentrations changed significantly from before to after treatment ( P < 0.01 ) , but the change did not differ between the combination and mitiglinide groups .
-RESULTS	The insulinogenic index increased significantly after the combination treatment ( P < 0.001 vs. mitiglinide or sitagliptin alone ) .
-RESULTS	The combination of mitiglinide and sitagliptin was generally well tolerated , with no hypoglycemic events .
-CONCLUSIONS	The combination of mitiglinide and sitagliptin did not trigger hypoglycemia and controlled postprandial glucose excursion more effectively compared with either drug alone .
-
-###24520741
-BACKGROUND	Alterations of the parameters of heart rate variability , phenomenon associated with autonomic nervous system balance , have been shown as a possibly very important factor for monitoring of cardiocirculatory system in the perioperative period .
-BACKGROUND	Periinduction period of general anaesthesia is very important with significant changes of haemodynamics what could be reflected in the changes of the parameter of heart rate variability .
-METHODS	A hundred patients of ASA I and ASA II status who were scheduled for elective abdominal surgical procedures of moderate stress response , were randomly assigned to group I and group II , who were administered propofol or thiopentone as induction anaesthetic , respectively .
-METHODS	Monitoring during periinduction period included of monitoring of mean blood pressure ( noninvasively ) , heart rate , pulseoxymetry and recording of electrocardiogram by holter ECG recorder for further analysis of heart rate variability , in four time segments in periinduction period : Tp , T1 , T2 , T3 .
-METHODS	Data were presented as mean values of absolute values of the power of the total spectrum of heart rate variability , mean values of the spectrum of low frequency band ( LF ) , mean values of the high frequency range , and the ratio LF/HF .
-RESULTS	Analysis of the values of hemodynamic parameters has shown decrease of mean arterial blood pressure after induction of anaesthesia with intravenous anesthetics thiopental or propofol , with simultaneous changes of heart rate in the four time segments in periinduction period , without statistically significant changes between the groups .
-RESULTS	Analysis of the values of parameters of heart rate variability measured in the frequency domain has shown changes of mean values of the absolute values of total power spectrum , mean values of the power of low frequency spectrum and mean values of the power of high power spectrum with reduction of the values of total power spectrum , the power of low frequency spectrum and the power of high frequency spectrum , most pronounced just after induction of anaesthesia with slight increase of the values of total power spectrum and individual components of the spectrum of heart rate variability in the later postinduction period , without statistically significant differences between the groups .
-CONCLUSIONS	The results have shown that in the groups of patients who underwent induction of general anaesthesia with propofol or thiopentone , there have been reductions of the total spectral power and the power of the spectrum of low frequency components and high frequency components with variations in the relationship between the components in the different periods of periinduction time .
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-###24986722
-BACKGROUND	In a task-environment where visibility has deteriorated , individuals rely heavily on tactile performance ( perception and manipulation ) to complete complex tasks .
-BACKGROUND	When this happens under hyperbaric conditions , factors like nitrogen narcosis could influence a person 's ability to successfully complete such tasks .
-OBJECTIVE	To examine the effect of nitrogen narcosis on a complex neuropsychological task measuring tactile performance at a pressure of 608 kPa ( 6 atm abs ) , in the absence of visual access to the task .
-METHODS	In a prospective cross-over study , 139 commercial divers were tested in a dry chamber at 101.3 kPa and 608 kPa .
-METHODS	They completed the Tupperware Neuropsychological Task ( TNT ) of tactile performance without visual access to the task , and completed questionnaires to provide psychological and biographical data , which included trait anxiety and transient mood states , as well as formal qualifications and technical proficiency .
-RESULTS	A significant decrement ( 9.5 % , P < 0.001 ) in performance on the TNT at depth was found , irrespective of the sequence of testing .
-RESULTS	Generally , neither the psychological nor biographical variables showed any significant effect on tactile performance .
-RESULTS	Tactile performance on the surface was a good indicator of performance at depth .
-CONCLUSIONS	These findings have practical implications for professional diving where conditions of low visibility during deeper diving occur .
-CONCLUSIONS	Recommendations are made towards managing potential impairments in tactile performance , such as pre-dive practical learning ( ` rehearsal ' ) as an aid to successful completion of tasks .
-
-###24928359
-OBJECTIVE	To compare the results for treatment of basal thumb osteoarthritis with and without the use of a bone tunnel at the base of the first metacarpal .
-METHODS	Women aged 40 years or older with stage IV osteoarthritis were randomized to 1 of 2 treatments .
-METHODS	Patients were evaluated preoperatively and postoperatively at 3 and 12 months by assessing pain , outcome function measures , range of motion , strength , time to return to work or activities , satisfaction with the results , and complication rate .
-RESULTS	A total of 79 patients were enrolled in this study .
-RESULTS	Three months after surgery , Patient-Rated Wrist and Hand Evaluation pain and total scores were significantly improved in the bone tunnel group compared with the tunnel-free group .
-RESULTS	At 12 months , however , we found no significant differences for all outcome scores between groups .
-RESULTS	In addition , we observed no significant differences between groups in strength , duration to return to work or activities , patient satisfaction , and complication rates .
-CONCLUSIONS	After the bone tunnel technique , patients have better function and less pain 3 months after surgery than do those in the non-bone tunnel group , which indicates faster recovery .
-CONCLUSIONS	However , 12 months after surgery , the functional outcome was similar .
-CONCLUSIONS	Because of faster recovery , we prefer the bone tunnel technique in the treatment of stage IV osteoarthritis .
-METHODS	Therapeutic I.
-
-###25329653
-BACKGROUND	Within the field of oncology , increasing access to high quality care has been identified as a priority to reduce cancer disparities .
-BACKGROUND	Previous research reveals that the facilities where patients receive their cancer care have implications for cancer outcomes .
-BACKGROUND	However , there is little understanding of how patients decide where to seek cancer care .
-BACKGROUND	This study examined the factors that shape patients ' pathways to seek their cancer care at a National Cancer Institute-designated comprehensive cancer center ( NCI-CCC ) , and differences in these factors by race , income and education .
-METHODS	In-depth interviews and survey questionnaires were administered to a random sample of 124 patients at one NCI-CCC in the Northeast US .
-METHODS	In-depth interview data was first analyzed qualitatively to identify themes and patterns in patients ' pathways to receive their cancer care at an NCI-CCC .
-METHODS	Logistic Regression was used to examine if these pathways varied by patient race , income , and education .
-RESULTS	Two themes emerged : following the recommendation of a physician and following advice from social network members .
-RESULTS	Quantitative data analysis shows that patient pathways to care at an NCI-CCC varied by education and income .
-RESULTS	Patients with lower income and education most commonly sought their cancer care at an NCI-CCC due to the recommendation of a physician .
-RESULTS	Patients with higher income and education most commonly cited referral by a specialist physician or the advice of a social network member .
-RESULTS	There were no statistically significant differences in pathways to care by race .
-CONCLUSIONS	Our findings show that most patients relied on physician recommendations or advice from a social network member in deciding to seek their cancer care at an NCI-CCC .
-CONCLUSIONS	Due to the role of physicians in shaping patients ' pathways to the NCI-CCC , initiatives that strengthen partnerships between NCI-CCCs and community physicians who serve underserved communities may improve access to NCI-CCCs .
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-###25571684
-OBJECTIVE	The aim of the present study is to determine the possible effect of Bifidobacterium bifidum DN-173 010 on dental plaque of children .
-METHODS	52 children ( 25 F and 27 M ) , between the ages of 8-10 , participated in the present study .
-METHODS	The study had a double blind , randomized crossover design and the experimental period consisted of four consecutive time periods .
-METHODS	During periods 2 and 4 ( 2 weeks each ) , children consumed 110 g probiotic fruit yogurt ( Bifidobacterium DN-173 010 ( 1 x 10 ( 10 ) cfu/g ) ) , or a placebo fruit yogurt per day .
-METHODS	Available supragingival plaque ( 24 h later ) was collected from teeth 16 , 11 , 36 and 31 at baseline and at the end of periods 2 and 4 .
-METHODS	The counts of dental plaque mutans streptococci ( MS ) were evaluated using Dentocult SM ( Strep Mutans ) .
-RESULTS	Changes of pre - and post-treatment levels of dental plaque MS were recorded for four consecutive sampling sites .
-RESULTS	There were no statistically differences between transition scores of test and placebo groups regarding different dental plaque sampling sites ( p > 0.05 ) ( unpaired t-test ) .
-CONCLUSIONS	Within the limitations of the present study , Bifidobacterium bifidum DN-173 010 has no effect on dental plaque MS levels in children .
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-###24957977
-OBJECTIVE	Accumulating evidence indicates that plastic changes can be maladaptive in nature , resulting in movement and neurological disorders .
-OBJECTIVE	The aim of this study was to further the understanding of these neurophysiological changes in sensorimotor integration ( SMI ) using somatosensory evoked potentials ( SEPs ) and concurrent performance changes following a repetitive typing task .
-METHODS	SEPs were recorded following median nerve stimulation at the wrist and performed pre and post intervention .
-METHODS	24 participants were randomly assigned to either an intervention group which performed a 20min repetitive typing task or a control group which participated in a 20min period of mental recitation .
-RESULTS	The P22-N24 amplitude increased by 59.6 % , compared to only 0.96 % increase following the control .
-RESULTS	The P22-N30 SEP peak amplitude increased on average 13.4 % following the motor training , compared to only 0.92 % following the control .
-RESULTS	Significant improvement in reaction time when comparing performance of the motor task for the intervention group was observed .
-CONCLUSIONS	The N24 increase supports the involvement of cerebellar connections and the N30 increase provides further support for changes in SMI following motor learning .
-CONCLUSIONS	Combining motor training tasks with electrophysiological techniques gives insight into the mechanisms of disordered SMI and whether the changes are adaptive or maladaptive .
-
-###25449510
-BACKGROUND	Electrocardiographic ( ECG ) identification of prior myocardial infarction ( MI ) during right ventricular ( RV ) pacing is of clinical importance .
-BACKGROUND	Proposed ECG criteria have been evaluated only during apical pacing .
-BACKGROUND	We evaluated the effect of pacing site on the predictive performance of ECG signs of prior MI .
-METHODS	The present study is a secondary analysis of a prospective , multicenter study which randomized recipients of an implantable cardioverter defibrillator to an apical versus septal RV lead positioning .
-METHODS	ECGs of patients with or without prior MI were analyzed for the presence of the following criteria : Cabrera sign , Chapman sign , QR pattern in leads I , aVL , V5 or V6 , QR in inferior leads and notching in the descending slope of the QRS complex in inferior leads .
-RESULTS	The MI group included 89 patients ( 55.1 % apically paced ) , while 99 patients had no prior MI ( 50.5 % apically paced ) .
-RESULTS	In the total population , the Cabrera sign presented the highest specificity ( 97 % ) and diagnostic accuracy ( 62.2 % ) , with a sensitivity of 23.6 % .
-RESULTS	The Cabrera sign was the only significant predictor of a prior MI [ OR = 9.9 , ( 95 % CI :2.8 -34.5 ) , p < 0.001 ] , among all ECG markers .
-RESULTS	Pacing site did not significantly influence the sensitivity and specificity of the Cabrera sign for detection of prior MI .
-CONCLUSIONS	In our study , the Cabrera sign was the only ECG marker that predicted the presence of prior MI during ventricular paced rhythm .
-CONCLUSIONS	Septal RV lead positioning did not affect the predictive performance of the Cabrera sign .
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-###24684104
-OBJECTIVE	To observe the protective effect of transcutaneous electrical acupoint stimulation ( TEAS ) on cerebral tissue in elderly hip replacement operation patients during general anesthesia under controlled hypotension .
-METHODS	Forty hip replacement operation patients were randomly divided into general anesthesia ( GA ) control group and TEAS + GA group ( n = 20 in each group ) .
-METHODS	Patients of the two groups during operation were treated with controlled hypotension for reducing blood loss .
-METHODS	TEAS ( 2 Hz/100 Hz , 8-12 mA ) was applied to bilateral Yuyao ( EX-HN 4 ) and Fengchi ( GB 20 ) and began 30 min before GA. .
-METHODS	General anesthesia was performed by intravenous injection of Midazolam , Diprivan , Fentanyl and Cis-atracurium , sevoflurane-inhaling , Remifentanil , etc. , and the patient 's mean arterial pressure was maintained to be about 70 % of the normal level ( controlled hypotension ) by using venous administration of Remifentanil about 10 min after the operation .
-METHODS	GEM Premier 3000 blood gas analyzer was used to analyze levels of the arterial oxygen ( CaO2 ) , internal jugular venous oxygen ( CjvO2 ) , arterio-venous oxygen content difference ( Da-jvO2 ) and cerebral oxygen ( CERO2 ) uptake rates of blood samples before controlled hypotension ( T0 ) , 20 min after controlled hypotension ( T ) .
-METHODS	40 min after controlled hypotension ( T2 ) and 20 min after the end of controlled hypotension ( T3 ) .
-RESULTS	Self-comparison of each group showed that in comparison with pre-controlled hypotension , CjvO2 levels at the time-points of T , T2 and T3 were significantly increased in both GA control and TEAS+GA groups ( P < 0.05 ) , while Da-jvO2 and CERO2 uptake rate levels at the time-points of T , .
-RESULTS	T2 and T3 in these two groups were significantly decreased ( P < 0.05 ) .
-RESULTS	Comparison between two groups showed that CivO2 levels at the time-points of T2 and T3 were significantly higher in the TEAS + GA group than in the GA control group ( P < 0.05 ) .
-RESULTS	while Da-jvO2 and CERO2 uptake rate levels at the time-point of T2 were obviously lower in the TEAS + GA group than in the GA control group ( P < 0.05 ) , suggesting a reduction of cerebral oxygen consumption after TEAS .
-RESULTS	No significant differences were found between these two groups in blood CjvO2 , Da-jvO2 and CERO2 uptake rate levels at the time-points of T0 and T1 ( P > 0.05 ) .
-CONCLUSIONS	TEAS can reduce cerebral oxygen uptake rate in elderly patients undergoing hip replacement during controlled hypotension , suggesting a protective effect of TEAS on patient 's cerebral tissue .
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-###25081652
-BACKGROUND	Home mechanical ventilation ( HMV ) in the Netherlands is normally initiated in hospital , but this is expensive and often a burden for the patient .
-BACKGROUND	In this randomised controlled study we investigated whether initiation of HMV at home in patients with chronic respiratory failure is non-inferior to an in hospital based setting .
-METHODS	Seventy-seven patients were included , of which 38 patients started HMV at home .
-METHODS	All patients were diagnosed with chronic respiratory failure due to a neuromuscular or thoracic cage disease .
-METHODS	Primary outcome was the arterial carbon dioxide ( PaCO2 ) while quality of life and costs were secondary outcomes .
-METHODS	Telemonitoring was used in the home group to provide therapeutic information , for example ; transcutaneous carbon dioxide , oxygen saturation and ventilator information , to the caregivers .
-METHODS	Follow-up was six months .
-RESULTS	PaCO2 , improved by 0.72 ( SE0 .16 ) kPa in the hospital group and by 0.91 ( 0.20 ) in the home group , both improvements being significant and the latter clearly not inferior .
-RESULTS	There were also significant improvements in quality of life in both groups , again not being inferior with home treatment .
-CONCLUSIONS	This study is the first to show that initiation of HMV at home in a selective group of patients with chronic respiratory failure is as effective for gas exchange and quality of life as hospital initiation .
-CONCLUSIONS	In addition we found that it is safe , technically feasible and that more than 3000 per patient can be saved compared to our standard care .
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-###24316711
-OBJECTIVE	To compare the three non-steroidal anti-inflammatory agents ( NSAIDs ) Diclofenac potassium , Etodolac and Naproxen sodium in relation to pain , swelling and trismus following impacted third molar surgery .
-METHODS	The study was a randomized and a double-blinded study which included 42 healthy young individuals with impacted third molars and bone retention .
-METHODS	Patients were randomly assigned to 3 groups ( n : 14 ) to which Diclofenac potassium , Naproxen sodium and Etodolac were administered orally an hour before the operation .
-METHODS	Impacted third molars were surgically extracted with local anaesthesia .
-METHODS	Visual analog scales ( VAS ) were used to assess the pain in the 6th , 12th hours and on the 1st , 2nd , 3rd , 5th , and 7th days postoperatively .
-METHODS	Swelling was evaluated using ultrasound ( US ) and mouth opening ( trismus ) was measured with a composing stick pre and post operatively on the 2nd and 7th days respectively .
-RESULTS	Regarding pain alleviation , Diclofenac potassium was better than Naproxen sodium and Naproxen sodium was better than Etodolac but these differences were not statistically significant .
-RESULTS	US measurements showed that the swelling on postoperative 2nd day was significantly lowest with Diclofenac potassium as compared to others ( p = 0.027 ) while Naproxen sodium and Etodolac acted similarly ( p = 0.747 ) .
-RESULTS	No difference was noted regarding trismus in any of the groups .
-CONCLUSIONS	NSAIDs ( Diclofenac , Naproxen and Etodolac ) are somehow similarly effective for controlling pain and trismus following extraction of mandibular third molars but Diclofenac potassium surpasses others in reduction of swelling .
-
-###24432626
-OBJECTIVE	To observe the efficacy of the combination of Qilin Pills and levofloxacin in the treatment of asthenospermia accompanied with accessory sex gland infection .
-METHODS	We randomly assigned 80 asthenospermia patients with accessory sex gland infection to groups 1 and 2 of equal number , the former treated with Qilin Pills + levofloxacin , and the latter with levofloxacin only .
-METHODS	Qilin Pills were administered at the dose of 6 g tid for 30 days , and levofloxacin at the dose of 0.5 g qd for 20 days .
-METHODS	We obtained semen parameters , including the percentage of progressively motile sperm and peroxidase-positive white blood cell ( WBC ) count , before and after medication , and compared the clinical effects between the two groups .
-RESULTS	All the patients accomplished the clinical trial .
-RESULTS	The therapeutic effectiveness rates in improving progressive sperm motility were 60 % in group 1 and 17.5 % in group 2 , with statistically significant differences between the two groups ( P < 0.05 ) .
-RESULTS	As for the peroxidase-positive WBC count in semen , the effectiveness rates were 87.5 % and 82.5 % , respectively , with no significant differences between the two groups ( P > 0.05 ) .
-CONCLUSIONS	For the treatment of asthenospermia accompanied with accessory sex gland infection , Qilin Pills combined with levofloxacin is evidently better than levofloxacin alone in improving sperm motility , and it has no obvious adverse effects .
-
-###25741969
-OBJECTIVE	To investigate the association between feeding patterns and HIV-free survival in children born to HIV-infected mothers and to clarify whether antiretroviral ( ARV ) prophylaxis modifies the association .
-METHODS	From June 2005 to August 2008 , HIV-infected pregnant women were counseled regarding infant feeding options , and randomly assigned to triple-ARV prophylaxis ( triple ARV ) until breastfeeding cessation ( BFC ) before age 6 months or antenatal zidovudine with single-dose nevirapine ( short-course ARV ) .
-METHODS	Eighteen-month HIV-free survival of infants HIV-negative at 2 weeks of age was assessed by feeding patterns ( replacement feeding from birth , BFC < 3 months , BFC 3 months ) .
-RESULTS	Of the 753 infants alive and HIV-negative at 2 weeks , 28 acquired infection and 47 died by 18 months .
-RESULTS	Overall HIV-free survival at 18 months was 0.91 [ 95 % confidence interval ( CI ) : 0.88-0 .93 ] .
-RESULTS	In the short-course ARV arm , HIV-free survival ( 0.88 ; CI : 0.84-0 .91 ) did not differ by feeding patterns .
-RESULTS	In the triple ARV arm , overall HIV-free survival was 0.93 ( CI : 0.90-0 .95 ) and BFC < 3 months was associated with lower HIV-free survival than BFC 3 months ( adjusted hazard ratio : 0.36 ; CI : 0.15-0 .83 ) and replacement feeding ( adjusted hazard ratio : 0.20 ; CI : 0.04-0 .94 ) .
-RESULTS	In the triple ARV arm , 4 of 9 transmissions occurred after reported BFC ( and 5 of 19 in the short-course arm ) , indicating that some women continued breastfeeding after interruption of ARV prophylaxis .
-CONCLUSIONS	In resource-constrained settings , early weaning has previously been associated with higher infant mortality .
-CONCLUSIONS	We show that , even with maternal triple-ARV prophylaxis during breastfeeding , early weaning remains associated with lower HIV-free survival , driven in particular by increased mortality .
-
-###25108545
-BACKGROUND	Fluticasone furoate ( FF ) is a novel , once-daily inhaled corticosteroid ( ICS ) that has been shown to improve lung function vs. placebo in asthma patients .
-BACKGROUND	This study evaluated the efficacy and safety of FF 50 mcg compared with placebo in asthma patients uncontrolled by non-ICS therapy .
-METHODS	This 12-week , multicentre , randomized , double-blind , placebo-controlled , parallel-group , phase III study randomized 248 patients ( aged 12 years ) to once-daily FF 50 mcg administered via the ELLIPTAa dry powder inhaler or placebo .
-METHODS	The primary endpoint was change from baseline in pre-dose evening trough forced expiratory volume in one second ( FEV1 ) .
-METHODS	Secondary endpoints were change from baseline in percentage of rescue-free 24-h periods ( powered ) , evening and morning peak expiratory flow , symptom-free 24-h periods and withdrawals due to lack of efficacy .
-METHODS	Other endpoints included Asthma Control Test , Asthma Quality of Life Questionnaire and ELLIPTA ease of use questions .
-METHODS	Safety was assessed throughout the study .
-RESULTS	There was a significant difference in evening trough FEV1 between FF 50 mcg and placebo ( treatment difference : 120 mL ; p = 0.012 ) .
-RESULTS	There was also a significant difference in rescue-free 24-h periods ( 11.6 % ; p = 0.004 ) vs. placebo .
-RESULTS	There were numerically greater improvements with FF vs. placebo for all remaining secondary endpoints .
-RESULTS	The incidence of adverse events was lower with FF ( 31 % ) than with placebo ( 38 % ) ; few were treatment-related ( FF 50 mcg : n = 1 , < 1 % ; placebo : n = 4 , 3 % ) .
-CONCLUSIONS	FF 50 mcg once daily significantly improved FEV1 and percentage of rescue-free 24-h periods experienced over 12 weeks vs. placebo , and was well tolerated .
-BACKGROUND	www.clinicaltrials.gov , registration number : NCT01436071 .
-
-###24921611
-OBJECTIVE	The aim of this study was to compare the effects of plyometric training versus basketball technique training on improving neuro-muscular performance .
-METHODS	Thirty-six ( age 14.90.9 years , body height 164.07.6 cm , body weight 54.08.7 kg , BMI 20.12.4 kgm-2 ) basketball players girls were randomly allocated to 2 groups : Basketball Plyometric Training ( BPT , N. = 18 ) and Basketball Technique Training ( BTT , N. = 18 ) .
-METHODS	The players were tested by two specific tests : counter movement jump ( CMJ ) and squat jump ( SJ ) before and after 6 training weeks .
-RESULTS	The jump height , as dependent variable , showed a different trend as an effect of the different training protocols , in contrast with the current knowledge .
-RESULTS	Manova did not show significant interactions between the two groups for the height of jumps , while significant differences were found for interaction time training ( P < 0.05 ) and for main effect time ( P < 0.001 ) .
-RESULTS	After training , the BPT group increased significantly CMJ performance by 11.3 % ( P < 0.05 ) , whereas the BTT group increased by 4.6 % .
-RESULTS	Likewise , the BPT group demonstrated a significant greater improvement of jump height than BTT group ( an increase of 15.4 % vs. 7.5 % , P < 0.01 ; respectively ) .
-CONCLUSIONS	These results suggest that both training protocols proposed in this study improved vertical jump performance .
-CONCLUSIONS	However , a combination of the two protocols , plyometric training and sport-specific-exercises , could be useful to optimize performance by an easy transition from controlled a-specific to sport-specific performance requirements .
-CONCLUSIONS	In conclusion , BPT is a safe and effective method of achieving a favourable neuro-muscular performance than BTT in female basketball players .
-
-###25377415
-OBJECTIVE	The objective of this study was to determine the feasibility of telementored instruction in bedside ultrasonography ( US ) using Google Glass .
-OBJECTIVE	The authors sought to examine whether first-time US users could obtain adequate parasternal long axis ( PSLA ) views to approximate ejection fraction ( EF ) using Google Glass telementoring .
-METHODS	This was a prospective , randomized , single-blinded study .
-METHODS	Eighteen second-year medical students were randomized into three groups and tasked with obtaining PSLA cardiac imaging .
-METHODS	Group A received real-time telementored education through Google Glass via Google Hangout from a remotely located expert .
-METHODS	Group B received bedside education from the same expert .
-METHODS	Group C represented the control and received no instruction .
-METHODS	Each subject was given 3 minutes to obtain a best PSLA cardiac imaging using a portable GE Vscan .
-METHODS	Image clips obtained by each subject were stored .
-METHODS	A second expert , blinded to instructional mode , evaluated images for adequacy and assigned an image quality rating on a 0 to 10 scale .
-RESULTS	Group A was able to obtain adequate images six out of six times ( 100 % ) with a median image quality rating of 7.5 ( interquartile range [ IQR ] = 6 to 10 ) out of 10 .
-RESULTS	Group B was also able to obtain adequate views six out of six times ( 100 % ) , with a median image quality rating of 8 ( IQR = 7 to 9 ) .
-RESULTS	Group C was able to obtain adequate views one out of six times ( 17 % ) , with a median image quality of 0 ( IQR = 0 to 2 ) .
-RESULTS	There were no statistically significant differences between Group A and Group B in the achievement of adequate images for E-point septal separation measurement or in image quality .
-CONCLUSIONS	In this pilot/feasibility study , novice US users were able to obtain adequate imaging to determine a healthy patient 's EF through telementored education using Google Glass .
-CONCLUSIONS	These preliminary data suggest telementoring as an adequate means of medical education in bedside US .
-CONCLUSIONS	This conclusion will need to be validated with larger , more powerful studies including evaluation of pathologic findings and varying body habitus among models .
-
-###24755132
-OBJECTIVE	To compare the pharmacokinetic profiles and to evaluate the bioequivalence of two commercial amoxicillin suspension formulations ( 500 mg/5 mL AMOXIL , reference formulation and AMOXI-PED , test formulation ) in healthy Brazilian volunteers .
-METHODS	Under fasting condition , 25 volunteers ( 13 males and 12 females ) were included in this randomized , open-label , two-period crossover ( 1-week washout interval ) bioequivalence study .
-METHODS	Blood samples were collected at pre-dose ( 0 hour ) and 0.5 , 1 , 1.33 , 1.66 , 2 , 2.5 , 3 , 4 , 6 , 8 , and 12 hours after drug ingestion .
-METHODS	Pharmacokinetic parameters ( Cmax , tmax , t1/2 , AUC0-tlast , and AUC0 - ) were calculated from plasma concentrations for both formulations in each subject .
-RESULTS	Arithmetic mean values of the pharmacokinetic parameters were : Cmax = 12.004 ( 2.824 ) gmL-1 ; tmax = 1.118 ( 0.396 ) h ; t1/2 = 1.226 ( 0.179 ) h ; AUC0-tlast = 29.297 ( 6.007 ) ghmL-1 ; and AUC0 - = 29.299 ( 6.007 ) ghmL-1 for reference formulation and Cmax = 11.456 ( 2.825 ) gmL-1 ; tmax = 1.331 ( 0.509 ) h ; t1/2 = 1.141 ( 0.133 ) h ; AUC0-tlast = 28.672 ( 5.778 ) ghmL-1 ; and AUC0 - = 28.693 ( 5.796 ) ghmL-1 for test formulation .
-RESULTS	The confidence intervals ( 90 % CI ) for reference and test formulations were , respectively , 90.74 - 100.46 % for Cmax and 93.62 - 103.61 % for AUC0-t .
-CONCLUSIONS	Based on the results , both formulations of amoxicillin evaluated in this study were considered bioequivalent according to FDA and ANVISA/Brazil criteria .
-
-###24870622
-OBJECTIVE	Autonomic nervous system dysfunction has been implicated in visceral hypersensitivity .
-OBJECTIVE	However , the specific contribution of the parasympathetic nervous system ( PNS ) is unclear .
-OBJECTIVE	We aimed to determine whether physiological and pharmacological manipulation of parasympathetic tone influences the development of hypersensitivity in a validated model of acid-induced oesophageal pain .
-METHODS	Prior to , and following , a 30-min distal oesophageal infusion of 0.15 M hydrochloric acid , pain thresholds to electrical stimulation were determined in the proximal non-acid exposed oesophagus in healthy subjects .
-METHODS	Validated sympathetic ( skin conductance response ) and parasympathetic ( cardiac vagal tone ) parameters were measured at baseline and continuously thereafter .
-METHODS	In study 1 , 55 subjects were randomised in a pragmatic blinded crossover design to receive deep breathing or un-paced breathing during acid infusion .
-METHODS	In study 2 , 32 subjects were randomised in a blinded , crossover design to receive intravenous atropine or placebo ( saline ) with deep breathing during acid infusion .
-RESULTS	Study 1 : Deep breathing increased cardiac vagal tone ( 2.12.3 vs -0.32.3 , p = 0.0006 ) with concomitant withdrawal of skin conductance response ( -0.64.9 vs 34.8 , p = 0.03 ) in comparison with un-paced breathing .
-RESULTS	Deep breathing prevented the development of acid-induced oesophageal hypersensitivity in comparison with sham breathing ( p = 0.0001 ) .
-RESULTS	Study 2 : Atropine , in comparison with placebo , blocked the attenuating effect of deep breathing on the development of acid-induced oesophageal hypersensitivity ( p = 0.046 ) .
-CONCLUSIONS	The development of oesophageal hyperalgesia is prevented by physiologically increasing parasympathetic tone .
-CONCLUSIONS	This effect is pharmacologically blocked with atropine , providing evidence that the PNS influences the development of oesophageal pain hypersensitivity .
-
-###26122460
-OBJECTIVE	Self-management challenges facing adults with epilepsy include limited understanding of the condition and treatment , associated psychosocial issues , and lack of community integration .
-OBJECTIVE	Self-management interventions improve patients ' medical , life role , and emotional management .
-OBJECTIVE	Previous interventions , developed from expert opinion , indicated issues with participant engagement/retention , and limited follow-up periods .
-OBJECTIVE	PACES in Epilepsy addressed methodologic concerns by utilizing patient needs assessment data ( n = 165 ) to derive self-management content and program features for evaluation via randomized controlled trial ( RCT ) .
-METHODS	Participants were adults with chronic epilepsy ( n = 83 ) , without serious mental illness or substantive intellectual impairment , who were recruited from two epilepsy centers .
-METHODS	Participants were assigned randomly to intervention or treatment-as-usual groups .
-METHODS	Outcomes included the Epilepsy Self-Management Scale ( ESMS ) , Epilepsy Self-Efficacy Scale ( ESES ) , Quality of Life in Epilepsy-31 ( QOLIE-31 ) , Patient Health Questionnaire-9 ( PHQ-9 ) , and the Generalized Anxiety Disorder-7 ( GAD-7 ) , administered at baseline , postintervention ( 8weeks ) , and 6months postintervention .
-METHODS	The intervention was an 8-week group of 6-8 adults co-led by a psychologist and trained peer with epilepsy that met one evening per week at a hospital for 75min .
-METHODS	Topics included medical , psychosocial , cognitive , and self-management aspects of epilepsy , in addition to community integration and optimizing epilepsy-related communication .
-METHODS	The treatment group provided satisfaction ratings regarding program features .
-RESULTS	PACES participants ( n = 38 ) improved relative to controls ( n = 40 ) on the ESMS ( p < 0.001 ) and subscales [ Information ( p < 0.001 ) ; Lifestyle ( p < 0.002 ) ] ; ESES ( p < 0.001 ) ; and QOLIE-31 ( p = 0.002 ) .
-RESULTS	At 6-month follow up , PACES participants remained improved on the ESMS ( p = 0.004 ) and Information subscale ( p = 0.009 ) ; and Energy/Fatigue ( p = 0.032 ) and Medication Effects ( p = 0.005 ) of the QOLIE-31 .
-RESULTS	Attrition in both groups was low ( 8 % in each group ) and all program satisfaction ratings exceeded 4.0 / 5.0 , with leadership ( 4.76 ) , topics ( 4.53 ) , and location ( 4.30 ) as the most highly rated aspects .
-CONCLUSIONS	A consumer generated epilepsy self-management program appears to be a promising intervention from multiple perspectives , particularly in relation to disability management .
-
-###25539660
-OBJECTIVE	Sublingual immunotherapy ( SLIT ) has been described as a significant intervention in the treatment of allergic rhinitis ( AR ) .
-OBJECTIVE	However , factors that may predict treatment outcomes with respect to quality of life ( QoL ) results and mainly the role of olfactory function are still being underestimated .
-OBJECTIVE	In this study , we investigated determinants that best predict treatment outcomes for QoL , exploring mainly the role of olfaction .
-METHODS	One hundred forty-five patients following SLIT , 45 placebo-controls , and 48 healthy subjects were studied .
-METHODS	Olfactory function was objectively evaluated using `` Sniffin ' Sticks '' test pre - and post-cessation of SLIT .
-METHODS	Three categories of validated QoL questionnaires were filled out by all subjects : questionnaire specific for olfaction ( Questionnaire of Olfactory Deficits ) , questionnaires for assessing psychology ( Beck Depression Inventory , Zung Depression Scale , State & Trait Anxiety Inventory ) , general Short Form-36 health survey .
-RESULTS	Statistically significant improvement of olfactory function by 11.1 % and of all QoL questionnaires results ( all P < .001 ) was observed on final evaluation .
-RESULTS	Anosmia , asthma history , and the severity of symptoms-expressed by the Total Symptoms Score-were proven independent determinants of clinically significant improvement in patients ' QoL .
-CONCLUSIONS	Several factors were found that may predict QoL outcomes in AR patients following SLIT .
-
-###25351119
-OBJECTIVE	To evaluate the effect of peer education on postoperative rehabilitation of patients with laryngeal cancer .
-METHODS	From January 2010 to December 2012 , 240 cases of primary laryngeal cancer were treated with partial or total laryngectomy as well as tracheotomy in the Department of Head and Neck Surgery in Shandong Provincial Hospital .
-METHODS	The patients were randomly divided into experimental group or control group by Stochastic tables law , 120 patients in control group accepted only conventional nursing , 120 patients in experimental group accepted both conventional nursing and peer education .
-METHODS	The difference in the treatment nursing cooperation attitude , postoperative recovery , postoperative symptoms and the incidence of complications between two groups were evaluated by postoperative quality of life ( UW-QOL ) , Eysenck personality questionnaire ( EPQ ) and coping style questionnaire ( CSQ ) score .
-METHODS	The independent sample T-test and test were used for statistical analysis .
-RESULTS	The patients of experimental group showed more positive attitude to treatment and care compared to the patients of control group ( = 10.7 , P < 0.01 ) .
-RESULTS	Experimental group had less time in postoperative wound healing time , gastric tube indwelling time and postoperative hospital stay than control group , with statistically significant differences ( t = 6.89 , t = 6.36 , t = 6.42 , respectively , P < 0.01 ) ; Incidence of postoperative discomfort symptoms in experimental group was less than that in control group ( P < 0.05 ) .
-RESULTS	Total score for quality of life ( UW-QOL ) in experimental group was higher than that in control group ( t = 2.40 , P < 0.05 ) .
-RESULTS	The P and N scores of EPQ in experimental group were lower than those in control group ( t = 2.28 , t = 2.60 , P < 0.05 ) , while the E score of EPQ in experimental group was significantly higher than that in control group ( t = 4.50 , P < 0.01 ) , with no significant difference in the L score of EPQ between two groups ( P > 0.05 ) .
-RESULTS	scores of factor to solve problem and help factor of CSQ in experimental group were higher than those in control group ( t = 7.05 , t = 7.73 , P < 0.01 ) , and the era factor score of experimental group was lower than that of control group ( t = 2.05 , P < 0.05 ) .
-CONCLUSIONS	Peer education can help the patients with laryngectomy to maintain good psychological and mental status , to cooperate actively with treatment , to reduce symptoms and complications , and to shorten the length of hospital stay , improving their postoperative rehabilitation and quality of life .
-
-###25272534
-OBJECTIVE	To further resolve the clinical equipoise on the choice of chemical sphincterotomy agent for early symptomatic relief of anal fissure by comparing the effectiveness of 2 % Diltiazem gel with 0.2 % Glyceryl TriNitrate .
-METHODS	The randomized clinical trial was conducted at Aga Khan University Hospital , Karachi , from February 1 , to July 30 , 2008 , and comprised 60 adult patients with anal fissure who were equally randomised to either Diltiazem or Glyceryl TriNitrate after taking informed consent .
-METHODS	The creams were applied locally ; the former twice daily , and the latter three times a day for a period of two weeks .
-METHODS	The rest of the treatment was standard .
-METHODS	Patients were followed up in clinic by the principal investigator at two weeks for primary outcome i.e. self-reported symptomatic relief on Visual Analogue Scale , and secondary outcomes i.e. side effects and the overall cost of treatment .
-RESULTS	Of the total , 31 ( 52 % ) patients were males and the overall mean age was 37 + / - 11 years .
-RESULTS	Patients , who used Diltiazem reported more symptomatic relief than Glyceryl TriNitrate ( p < 0.01 ) .
-RESULTS	Side effects were found more in Glyceryl TriNitrate than Diltiazem ( p < 0.01 ) , and most common side effect in the former group was headache in 12 ( 40 % ) patients .
-RESULTS	Cost of the treatment was not significantly different between both treatment arms ( p < 0.28 ) .
-CONCLUSIONS	Chemical sphincterotomy with topical 2 % Diltiazem gel is an effective first-line treatment for early symptomatic relief of anal fissures , owing to negligible side effects .
-
-###25226476
-OBJECTIVE	Antenatal magnesium sulfate given to pregnant women at imminent risk of very preterm delivery reduces the risk of cerebral palsy in early childhood , although its effects into school age have not been reported from randomized trials .
-OBJECTIVE	To determine the association between exposure to antenatal magnesium sulfate and neurological , cognitive , academic , and behavioral outcomes at school age .
-METHODS	The ACTOMgSO4 was a randomized clinical trial conducted in 16 centers in Australia and New Zealand , comparing magnesium sulfate with placebo given to pregnant women ( n = 535 magnesium ; n = 527 placebo ) for whom imminent birth was planned or expected before 30 weeks ' gestation .
-METHODS	Children who survived from the 14 centers who participated in the school-age follow-up ( n = 443 magnesium ; n = 424 placebo ) were invited for an assessment at 6 to 11 years of age between 2005 and 2011 .
-METHODS	Mortality , cerebral palsy , motor function , IQ , basic academic skills , attention and executive function , behavior , growth , and functional outcomes .
-METHODS	Main analyses were imputed for missing data .
-RESULTS	Of the 1255 fetuses known to be alive at randomization , the mortality rate to school age was 14 % ( 88/629 ) in the magnesium sulfate group and 18 % ( 110/626 ) in the placebo group ( risk ratio [ RR ] , 0.80 ; 95 % CI , 0.62-1 .03 , P = .08 ) .
-RESULTS	Of 867 survivors available for follow-up , outcomes at school age ( corrected age 6-11 years ) were determined for 669 ( 77 % ) .
-RESULTS	Comparing the magnesium sulfate and placebo groups revealed no statistically significant difference in proportions with cerebral palsy ( 23/295 [ 8 % ] and 21/314 [ 7 % ] , respectively ; odds ratio [ OR ] , 1.26 ; 95 % CI , 0.84-1 .91 ; P = .27 ) or abnormal motor function ( 80/297 [ 27 % ] and 80/300 [ 27 % ] , respectively ; OR , 1.16 ; 95 % CI , 0.88-1 .52 ; P = .28 ) .
-RESULTS	There was also little difference between groups on any of the cognitive , behavioral , growth , or functional outcomes .
-CONCLUSIONS	Magnesium sulfate given to pregnant women at imminent risk of birth before 30 weeks ' gestation was not associated with neurological , cognitive , behavioral , growth , or functional outcomes in their children at school age , although a mortality advantage can not be excluded .
-CONCLUSIONS	The lack of long-term benefit requires confirmation in additional studies .
-BACKGROUND	anzctr.org.au Identifier : ACTRN12606000252516 .
-
-###26055947
-BACKGROUND	The U.S. pivotal trial for the self-expanding valve found that among patients with severe aortic stenosis at increased risk for surgery , the 1-year survival rate was 4.9 percentage points higher in patients treated with a self-expanding transcatheter aortic valve bioprosthesis than in those treated with a surgical bioprosthesis .
-OBJECTIVE	Longer-term clinical outcomes were examined to confirm if this mortality benefit is sustained .
-METHODS	Patients with severe aortic stenosis who were at increased surgical risk were recruited .
-METHODS	Eligible patients were randomly assigned in a 1:1 ratio to transcatheter aortic valve replacement with the self-expanding transcatheter valve ( transcatheter aortic valve replacement [ TAVR ] group ) or to aortic valve replacement with a surgical bioprosthesis ( surgical group ) .
-METHODS	The 2-year clinical and echocardiographic outcomes were evaluated in these patients .
-RESULTS	A total of 797 patients underwent randomization at 45 centers in the United States .
-RESULTS	The rate of 2-year all-cause mortality was significantly lower in the TAVR group ( 22.2 % ) than in the surgical group ( 28.6 % ; log-rank test p < 0.05 ) in the as-treated cohort , with an absolute reduction in risk of 6.5 percentage points .
-RESULTS	Similar results were foundin the intention-to-treat cohort ( log-rank test p < 0.05 ) .
-RESULTS	The rate of 2-year death or major stroke was significantly lower in the TAVR group ( 24.2 % ) than in the surgical group ( 32.5 % ; log-rank test p = 0.01 ) .
-CONCLUSIONS	In patients with severe aortic stenosis who are at increased surgical risk , the higher rate of survival with a self-expanding TAVR compared with surgery was sustained at 2 years .
-CONCLUSIONS	( Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement ; NCT01240902 ) .
-
-###25036417
-BACKGROUND	A prospective , randomized study examined the effect of interventional preoperative education and orientation for scoliosis surgery ( PEOSS ) on anxiety levels of patients undergoing posterior spinal fusion ( PSF ) .
-BACKGROUND	Secondary outcomes analyzed were caregiver anxiety , length of stay , morphine equivalent usage , and patient/caregiver satisfaction .
-METHODS	Patients undergoing PSF were randomly distributed into a control group ( N = 39 ) or interventional group ( N = 26 ) .
-METHODS	All subjects and caregivers completed the State ( current ) - Trait ( typical ) Anxiety Inventory ( STAI ) at different intervals : preoperative appointment , preoperative holding area , postoperative orthopaedic unit , and discharge .
-METHODS	At discharge , patients and caregivers completed a satisfaction survey .
-RESULTS	Significantly higher state anxiety scores were found compared with baseline at all time intervals in both the control group and PEOSS group .
-RESULTS	The PEOSS group had higher state anxiety scores than the control group at the postoperative interval ( P = 0.024 ) .
-RESULTS	There were no significant differences in the caregiver state anxiety scores between the groups at any time interval .
-RESULTS	Trait anxiety scores for both groups remained stable over time , establishing that the measurement tool accurately reflected baseline anxiety .
-RESULTS	No significant differences were found in length of stay or morphine equivalent use .
-RESULTS	Patient satisfaction scores were higher in the PEOSS group than in the control group ( P = 0.0005 ) .
-CONCLUSIONS	PSF was associated with increased anxiety at all time intervals in adolescents in both groups .
-CONCLUSIONS	In the PEOSS group , PSF was associated with increased anxiety in the immediate postoperative period .
-CONCLUSIONS	Despite the increase in anxiety , patient satisfaction was higher in the intervention group .
-CONCLUSIONS	It is likely that patients need age-appropriate information and educational strategies to minimize anxiety during PSF .
-CONCLUSIONS	Further work is underway to study and develop more effective interventional strategies .
-METHODS	Level I study .
-
-###25040840
-OBJECTIVE	This randomized double-blind study was conducted to evaluate the analgesic efficacy and safety of addition of three different doses of dexmedetomidine in caudal ropivacaine compared with plain ropivacaine for postoperative analgesia in pediatric day care patients .
-METHODS	Eighty children of American Society of Anesthesiologists grade I-II , aged 1-8 years , undergoing lower abdominal and perineal surgery were included .
-METHODS	Children were randomly allocated into four groups .
-METHODS	Group 1 received 0.2 % plain ropivacaine 0.75 mlkg ( -1 ) , while group 2 , 3 , and 4 received dexmedetomidine 0.5 , 1.0 , and 1.5 gkg ( -1 ) , respectively , along with 0.2 % ropivacaine 0.75 mlkg ( -1 ) .
-METHODS	Anesthesia was induced and maintained with sevoflurane and 50 % N2O in oxygen .
-METHODS	Children were observed for postoperative pain , nausea-vomiting , agitation , sedation , and adverse effects .
-METHODS	Rescue analgesia was provided with oral paracetamol .
-RESULTS	Postoperative analgesia was significantly prolonged in all dexmedetomidine groups as compared to plain ropivacaine group ( P < 0.001 ) .
-RESULTS	All patients in the plain ropivacaine group required rescue analgesia within first 6 postoperative hours , while none in the other three groups .
-RESULTS	None of the patients showed delayed anesthetic emergence .
-RESULTS	Four patients in the plain ropivacaine group developed agitation , while none in the dexmedetomidine groups .
-RESULTS	Patients receiving dexmedetomidine 1.5 gkg ( -1 ) were more sedated as compared to the other groups ( P < 0.01 ) , but it did not delay discharge of the patients .
-CONCLUSIONS	All three doses of caudal dexmedetomidine appear to be effective for preventing postoperative pain in pediatric day care patients .
-CONCLUSIONS	Caudal dexmedetomidine used in these doses seems to be safe for day care surgery .
-
-###25398374
-OBJECTIVE	Tofacitinib is an oral Janus kinase ( JAK ) inhibitor for the treatment of rheumatoid arthritis ( RA ) .
-OBJECTIVE	The pathways affected by tofacitinib and the effects on gene expression in situ are unknown .
-OBJECTIVE	Therefore , tofacitinib effects on synovial pathobiology were investigated .
-METHODS	A randomised , double-blind , phase II serial synovial biopsy study ( A3921073 ; NCT00976599 ) in patients with RA with an inadequate methotrexate response .
-METHODS	Patients on background methotrexate received tofacitinib 10mg twice daily or placebo for 28days .
-METHODS	Synovial biopsies were performed on Days -7 and 28 and analysed by immunoassay or quantitative PCR .
-METHODS	Clinical response was determined by disease activity score and European League Against Rheumatism ( EULAR ) response on Day 28 in A3921073 , and at Month 3 in a long-term extension study ( A3921024 ; NCT00413699 ) .
-RESULTS	Tofacitinib exposure led to EULAR moderate to good responses ( 11/14 patients ) , while placebo was ineffective ( 1/14 patients ) on Day 28 .
-RESULTS	Tofacitinib treatment significantly reduced synovial mRNA expression of matrix metalloproteinase ( MMP ) -1 and MMP-3 ( p < 0.05 ) and chemokines CCL2 , CXCL10 and CXCL13 ( p < 0.05 ) .
-RESULTS	No overall changes were observed in synovial inflammation score or the presence of T cells , B cells or macrophages .
-RESULTS	Changes in synovial phosphorylation of signal transducer and activator of transcription 1 ( STAT1 ) and STAT3 strongly correlated with 4-month clinical responses ( p < 0.002 ) .
-RESULTS	Tofacitinib significantly decreased plasma CXCL10 ( p < 0.005 ) at Day 28 compared with placebo .
-CONCLUSIONS	Tofacitinib reduces metalloproteinase and interferon-regulated gene expression in rheumatoid synovium , and clinical improvement correlates with reductions in STAT1 and STAT3 phosphorylation .
-CONCLUSIONS	JAK1-mediated interferon and interleukin-6 signalling likely play a key role in the synovial response .
-BACKGROUND	NCT00976599 .
-
-###24287222
-BACKGROUND	Patellar straps or sports tapes are commonly used by athletes with patellar tendinopathy in order to reduce pain and to continue sports participation .
-BACKGROUND	Currently , there is no scientific evidence for the effectiveness of a patellar strap or sports tape in the management of this common injury .
-OBJECTIVE	To investigate the effect of the use of a patellar strap and sports tape on pain and sports participation in subjects with patellar tendinopathy .
-METHODS	The study is divided into two parts : a randomised controlled crossover experiment and a randomised controlled trial ( parallel group design ) .
-METHODS	140 patients diagnosed with patellar tendinopathy recruited from sports medical centres and physiotherapist practices .
-METHODS	In the first part of the study , participants serve as their own control by performing three functional tests under four different conditions ( patellar strap , sports tape , placebo tape , and no orthosis ) .
-METHODS	In the second part , participants keep a log for two weeks ( control week and intervention week ) about the pain experienced during and after sports and their level of sports participation .
-METHODS	In the intervention week participants will use the orthosis assigned to them during training and competition .
-METHODS	The amount of pain ( both parts of the study ) and sports participation ( second part only ) will be measured .
-METHODS	To analyse the effects of the orthoses a Linear Mixed Model will be used .
-CONCLUSIONS	The knowledge gained in this study can be used by practitioners in their advice for athletes with patellar tendinopathy about using patellar strap and sports tape during sports .
-
-###25012934
-OBJECTIVE	A head-to-head comparison was performed between vascular endothelial growth factor blockade and laser for treatment of diabetic macular edema ( DME ) .
-METHODS	Two similarly designed , double-masked , randomized , phase 3 trials , VISTA ( DME ) and VIVID ( DME ) .
-METHODS	We included 872 patients ( eyes ) with type 1 or 2 diabetes mellitus who presented with DME with central involvement .
-METHODS	Eyes received either intravitreal aflibercept injection ( IAI ) 2 mg every 4 weeks ( 2q4 ) , IAI 2 mg every 8 weeks after 5 initial monthly doses ( 2q8 ) , or macular laser photocoagulation .
-METHODS	The primary efficacy endpoint was the change from baseline in best-corrected visual acuity ( BCVA ) in Early Treatment Diabetic Retinopathy Study ( ETDRS ) letters at week 52 .
-METHODS	Secondary efficacy endpoints at week 52 included the proportion of eyes that gained 15 letters from baseline and the mean change from baseline in central retinal thickness as determined by optical coherence tomography .
-RESULTS	Mean BCVA gains from baseline to week 52 in the IAI 2q4 and 2q8 groups versus the laser group were 12.5 and 10.7 versus 0.2 letters ( P < 0.0001 ) in VISTA , and 10.5 and 10.7 versus 1.2 letters ( P < 0.0001 ) in VIVID .
-RESULTS	The corresponding proportions of eyes gaining 15 letters were 41.6 % and 31.1 % versus 7.8 % ( P < 0.0001 ) in VISTA , and 32.4 % and 33.3 % versus 9.1 % ( P < 0.0001 ) in VIVID .
-RESULTS	Similarly , mean reductions in central retinal thickness were 185.9 and 183.1 versus 73.3 m ( P < 0.0001 ) in VISTA , and 195.0 and 192.4 versus 66.2 m ( P < 0.0001 ) in VIVID .
-RESULTS	Overall incidences of ocular and nonocular adverse events and serious adverse events , including the Anti-Platelet Trialists ' Collaboration-defined arterial thromboembolic events and vascular deaths , were similar across treatment groups .
-CONCLUSIONS	At week 52 , IAI demonstrated significant superiority in functional and anatomic endpoints over laser , with similar efficacy in the 2q4 and 2q8 groups despite the extended dosing interval in the 2q8 group .
-CONCLUSIONS	In general , IAI was well-tolerated .
-
-###25552402
-OBJECTIVE	To determine the effects of food on the pharmacokinetics of sublingual asenapine .
-METHODS	Healthy male volunteers ( n = 26 , age 19-53 years ) randomly received a single sublingual dose of asenapine 5 mg after 10 h fasting ( Treatment A , reference ) , after a high-fat meal ( Treatment B ) and after 10 h fasting with a high-fat meal at 4 h post-dose ( Treatment C ) .
-METHODS	Blood samples were drawn over 72 h to measure asenapine plasma concentrations .
-METHODS	Effects of food intake on asenapine pharmacokinetics were assessed using bioequivalence criteria and evaluated using a compartmental modelling analysis .
-RESULTS	Compared with the reference , mean asenapine exposure ( AUC0-last and AUC0 - ) was approximately 20 % lower after intake of a high-fat meal prior to dosing , whereas Cmax decreased by only about 10 % .
-RESULTS	When a high-fat meal was taken 4 h post-dose in the fasting state , asenapine concentrations were similar to the reference during the first 4 h post-dose .
-RESULTS	After the meal intake , asenapine concentrations decreased quickly for several hours .
-RESULTS	Compartmental modelling indicated that a transient 2.5-fold increase in asenapine clearance after eating could explain the asenapine concentration-time profiles for both food regimens .
-CONCLUSIONS	To our knowledge , this is the first study investigating the effect of food upon the sublingual administration of a drug .
-CONCLUSIONS	A high-fat meal taken before or 4 h post-dose of sublingual asenapine indirectly caused a transient increase in liver blood flow that resulted in a temporal increase in asenapine clearance .
-CONCLUSIONS	As the effects on asenapine exposure were small and not clinically relevant , no additional restrictions are required for the timing of food intake in relation to asenapine dosing .
-
-###25527766
-BACKGROUND	Little is known about how the genetic variation in vitamin D modulating genes influences ultraviolet ( UV ) B-induced 25-hydroxyvitamin D [ 25 ( OH ) D ] concentrations .
-BACKGROUND	In the Food with vitamin D ( VitmaD ) study , we showed that common genetic variants rs10741657 and rs10766197 in 25-hydroxylase ( CYP2R1 ) and rs842999 and rs4588 in vitamin D binding protein ( GC ) predict 25 ( OH ) D concentrations at late summer and after 6-mo consumption of cholecalciferol ( vitamin D ) - fortified bread and milk .
-OBJECTIVE	In the current study , called the Vitamin D in genes ( VitDgen ) study , we analyzed associations between the increase in 25 ( OH ) D concentrations after a given dose of artificial UVB irradiation and 25 single nucleotide polymorphisms located in or near genes involved in vitamin D synthesis , transport , activation , or degradation as previously described for the VitmaD study .
-OBJECTIVE	Second , we aimed to determine whether the genetic variations in CYP2R1 and GC have similar effects on 25 ( OH ) D concentrations after artificial UVB irradiation and supplementation by vitamin D-fortified bread and milk .
-METHODS	The VitDgen study includes 92 healthy Danes who received 4 whole-body UVB treatments with a total dose of 6 or 7.5 standard erythema doses during a 10-d period in winter .
-METHODS	The VitmaD study included 201 healthy Danish families who were given vitamin D-fortified bread and milk or placebo for 6 mo during the winter .
-RESULTS	After UVB treatments , rs10741657 in CYP2R1 and rs4588 in GC predicted UVB-induced 25 ( OH ) D concentrations as previously shown in the VitmaD study .
-RESULTS	Compared with noncarriers , carriers of 4 risk alleles of rs10741657 and rs4588 had lowest concentrations and smallest increases in 25 ( OH ) D concentrations after 4 UVB treatments and largest decreases in 25 ( OH ) D concentrations after 6-mo consumption of vitamin D-fortified bread and milk .
-CONCLUSIONS	Common genetic variants in the CYP2R1 and GC genes modify 25 ( OH ) D concentrations in the same manner after artificial UVB-induced vitamin D and consumption of vitamin D-fortified bread and milk .
-
-###26180950
-OBJECTIVE	We evaluated a low-cost strategy for schools to improve the convenience and appeal of drinking water .
-METHODS	We conducted a group-randomized , controlled trial in 10 Boston , Massachusetts , schools in April through June 2013 to test a cafeteria-based intervention .
-METHODS	Signage promoting water and disposable cups were installed near water sources .
-METHODS	Mixed linear regression models adjusting for clustering evaluated the intervention impact on average student water consumption over 359 lunch periods .
-RESULTS	The percentage of students in intervention schools observed drinking water during lunch nearly doubled from baseline to follow-up compared with controls ( + 9.4 % ; P < .001 ) .
-RESULTS	The intervention was associated with a 0.58-ounce increase in water intake across all students ( P < .001 ) .
-RESULTS	Without cups , children were observed drinking 2.4 ( SE = 0.08 ) ounces of water from fountains ; with cups , 5.2 ( SE = 0.2 ) ounces .
-RESULTS	The percentage of intervention students observed with sugar-sweetened beverages declined ( -3.3 % ; P < .005 ) .
-CONCLUSIONS	The current default of providing water through drinking fountains in cafeterias results in low water consumption .
-CONCLUSIONS	This study shows that an inexpensive intervention to improve drinking water 's convenience by providing cups can increase student water consumption .
-
-###24975199
-BACKGROUND	Topical photodynamic therapy ( PDT ) for actinic keratoses ( AK ) is hampered by pain during illumination and inferior efficacy in organ-transplant recipients ( OTR ) .
-OBJECTIVE	We assessed ablative fractional laser ( AFL ) - assisted daylight photodynamic therapy ( PDT ) ( AFL-dPDT ) compared with daylight PDT ( dPDT ) , conventional PDT ( cPDT ) and AFL alone ( AFL ) in field treatment of AK in OTR .
-METHODS	In each patient , four areas in the same region were randomized to one treatment with AFL-dPDT , dPDT , cPDT and AFL .
-METHODS	AFL was delivered with a 2940-nm AFL at 23 mJ per pulse , 115 W , two stacks , 50-s pulse-duration , 24 % density .
-METHODS	In dPDT and AFL-dPDT , methyl aminolaevulinate ( MAL ) was applied for 25 h without occlusion during daylight exposure .
-METHODS	For cPDT , MAL was occluded for 3 h followed by red-light ( 630 nm ) irradiation at 37 J cm ( -2 ) .
-METHODS	The primary end-point was complete response ( CR ) 3 months post-treatment .
-RESULTS	Sixteen patients with 542 AK ( grades I-III ) in field-cancerized skin of the scalp , chest and extremities were treated during August and September 2012 .
-RESULTS	After 3 months , CR ( AK I-III ) rates were 74 % after AFL-dPDT , 46 % after dPDT , 50 % after cPDT and 5 % after AFL ( P < 0001 ) .
-RESULTS	CR rates in AFL-dPDT , dPDT and cPDT were also significantly different ( P = 0004 ) .
-RESULTS	Median maximal pain scores differed significantly during AFL-dPDT ( 0 ) , dPDT ( 0 ) , AFL ( 0 ) and cPDT ( 5 ) ( P < 0001 ) .
-RESULTS	Erythema and crusting were more intense following AFL-dPDT than dPDT and cPDT , but only transient hypopigmentation was observed .
-CONCLUSIONS	AFL-dPDT is a novel PDT modality that enhances CR with excellent tolerability compared with dPDT and cPDT in difficult-to-treat AK in OTR .
-
-###25537443
-BACKGROUND	Microprocessor knees have improved the gait and functional abilities of persons with transfemoral amputation .
-BACKGROUND	The Genium prosthetic knee offers an advanced sensor and control system designed to decrease impairment by : allowing greater stance phase flexion , easing transitions between gait phases , and compensating for changes in terrain .
-BACKGROUND	The aim of this study was to determine differences between the knee flexion angle of persons using the Genium knee , the C-Leg knee , and non-amputee controls ; and to evaluate the impact the prostheses on gait and level of impairment of the user .
-METHODS	This study used a randomized experimental crossover of persons with transfemoral amputation using the Genium and C-Leg microprocessor knees ( n = 25 ) , with an observational sample of non-amputee controls ( n = 5 ) .
-METHODS	Gait analysis by 3D motion tracking of subjects ambulating at different speeds on level ground and on 5 and 10 ramps was completed .
-RESULTS	Use of the Genium resulted in a significant increase in peak knee flexion for swing ( 5 , p < 0.01 , d = 0.34 ) and stance ( 2 , p < 0.01 , d = 0.19 ) phases relative to C-Leg use .
-RESULTS	There was a high degree of variability between subjects , and significant differences still remain between the Genium group and the control group 's knee flexion angles for most speeds and slopes .
-CONCLUSIONS	The Genium knee generally increases flexion in swing and stance , potentially decreasing the level of impairment for persons with transfemoral amputation .
-CONCLUSIONS	This study demonstrates functional differences between the C-Leg and Genium knees to help prosthetists determine if the Genium will provide functional benefits to individual patients .
-
-###26068325
-OBJECTIVE	The present study aimed to assess the effects of two different sports training methods - traditional and maturational - on the flexibility of female rhythmic gymnasts at different levels of biological maturation .
-METHODS	The sample consisted of 120 children , randomly divided ( by draw ) into six groups of 20 children ( eight and nine-years old ) : traditional training group ( TG ) ; maturational training group ( MG ) ; and the control group ( CG ) .
-METHODS	These were subdivided into early , normal and late , based on biological maturation assessment by hand/wrist X-ray examination .
-METHODS	Flexibility was evaluated by angle goniometer testing , applying the LABIFIE protocol .
-METHODS	A Lafayette Goniometer Set and Hoorn-Brasil exercise mat were used and the following exercises were performed : external shoulder rotation ( ESR ) and lumbar flexion ( LF ) .
-METHODS	Both the TG and MG participated in twice-weekly , 45-minute rhythmic gymnastics classes over 16 weeks .
-METHODS	The TG used the traditional sports training method while the MG executed sporting activities according to biological maturation .
-METHODS	The CG received no special treatment .
-RESULTS	The results showed a significant improvement ( P < 0.001 ) in the subgroups ( late , normal and early ) for both variables ( ESR = 7.54 and LF = 7.51 ) in the eight and nine-year age groups .
-RESULTS	Moreover , in relation to division by biological maturity , better results were recorded in the early subgroups .
-CONCLUSIONS	Thus , it can be inferred that , due to the changes in important physical parameters as a result of maturation , selecting children for physical education should not be based solely on chronological , but primarily on biological maturation .
-
-###24293753
-OBJECTIVE	Gender differences in the prevalence of sleep apnea/hypopnea syndrome may be mediated via male sex hormones .
-OBJECTIVE	Our objective was to determine the exact pathway for a testosterone-mediated increased propensity for central sleep apnea via blockade of the 5-reductase pathway of testosterone conversion by finasteride .
-METHODS	Randomization to oral finasteride vs. sham , single-center study .
-METHODS	Sleep research laboratory .
-METHODS	Fourteen healthy young males without sleep apnea .
-METHODS	Hypocapnia was induced via brief nasal noninvasive positive pressure ventilation during stable NREM sleep .
-METHODS	Cessation of mechanical ventilation resulted in hypocapnic central apnea or hypopnea .
-RESULTS	The apnea threshold ( AT ) was defined as the end-tidal CO ( P ( ET ) CO ) that demarcated the central apnea closest to the eupneic P ( ET ) CO. .
-RESULTS	The CO reserve was defined as the difference in P ( ET ) CO between eupnea and AT .
-RESULTS	The apneic threshold and CO reserve were measured at baseline and repeated after at a minimum of 1 month .
-RESULTS	Administration of finasteride resulted in decreased serum dihydrotestosterone .
-RESULTS	In the finasteride group , the eupneic ventilatory parameters were unchanged ; however , the AT was decreased ( 38.9 0.6 mm Hg vs. 37.7 0.9 mm Hg , P = 0.02 ) and the CO reserve was increased ( -2.5 0.3 mm Hg vs. -3.8 0.5 mm Hg , P = 0.003 ) at follow-up , with a significantly lower hypocapnic ventilatory response , thus indicating increased breathing stability during sleep .
-RESULTS	No significant changes were noted in the sham group on follow-up study .
-CONCLUSIONS	Inhibition of testosterone action via the 5-reductase pathway may be effective in alleviating breathing instability during sleep , presenting an opportunity for novel therapy for central sleep apnea in selected populations .
-
-###24823927
-OBJECTIVE	Alternative drug therapies are needed for the treatment of portal hypertension .
-OBJECTIVE	The aim of this randomized study was to evaluate and compare the effects of carvedilol and nebivolol on the hepatic venous pressure gradient ( HVPG ) response in the patients with liver cirrhosis .
-METHODS	In total , 20 cirrhotic patients were randomized into 2 groups and treated with carvedilol ( n = 10 ) or nebivolol ( n = 10 ) .
-METHODS	HVPG was measured at baseline , 60 minutes after the administration of carvedilol ( 25 mg ) or nebivolol ( 5 mg ) , and after 14 days of carvedilol ( 25 mg ) or nebivolol ( 5 mg ) administered daily .
-METHODS	RESULTS .
-METHODS	Carvedilol significantly reduced HVPG from 22.2 mm Hg ( SD , 4.4 ) to 15.2 mm Hg ( SD , 3.7 ) after 60 minutes and to 16.4 mm Hg ( SD , 2.9 ) after 14 days ( P < 0.01 ) .
-METHODS	Nebivolol reduced HVPG from 19.7 mm Hg ( SD , 2.5 ) to 15.7 mm Hg ( SD , 2.6 ) and 16.7 mm Hg ( SD , 3.2 ) , respectively ( P < 0.02 ) .
-METHODS	Carvedilol effectively decreased HVPG in a greater proportion of the patients after an acute probe ( 88 % vs. 57 % ) and after 14 days of the treatment ( 88 % vs. 28 % , P < 0.05 ) in comparison with nebivolol .
-CONCLUSIONS	Carvedilol and nebivolol reduce HVPG in cirrhotic patients ; however , the effect of carvedilol on the HVPG reduction might be superior to that of nebivolol , especially after 14 days of treatment .
-
-###25315663
-OBJECTIVE	To compare the efficacy and safety of intravitreal aflibercept injection ( IAI ) with macular grid laser photocoagulation for the treatment of macular edema after branch retinal vein occlusion ( BRVO ) .
-METHODS	The VIBRANT study was a double-masked , active-controlled , randomized , phase III trial .
-METHODS	Treatment-nave eyes with macular edema after BRVO were included in the study if the occlusion occurred within 12 months and best-corrected visual acuity ( BCVA ) was between 73 and 24 Early Treatment Diabetic Retinopathy Study ( ETDRS ) letters ( 20/40-20 / 320 Snellen equivalent ) .
-METHODS	Eyes ( 1 eye per patient ) received either IAI 2 mg every 4 weeks ( n = 91 ) from baseline to week 20 or grid laser ( n = 92 ) at baseline with a single grid laser rescue treatment , if needed , from weeks 12 through 20 .
-METHODS	The primary outcome measure was the proportion of eyes that gained 15 ETDRS letters from baseline BCVA at week 24 .
-METHODS	Secondary end points included mean change from baseline BCVA and central retinal thickness ( CRT ) at week 24 .
-RESULTS	The proportion of eyes that gained 15 ETDRS letters from baseline at week 24 was 52.7 % in the IAI group compared with 26.7 % in the laser group ( P = 0.0003 ) .
-RESULTS	The mean improvement from baseline BCVA at week 24 was 17.0 ETDRS letters in the IAI group and 6.9 ETDRS letters in the laser group ( P < 0.0001 ) .
-RESULTS	The mean reduction in CRT from baseline at week 24 was 280.5 m in the IAI group and 128.0 m in the laser group ( P < 0.0001 ) .
-RESULTS	Traumatic cataract in an IAI patient was the only ocular serious adverse event ( SAE ) that occurred .
-RESULTS	There were no cases of intraocular inflammation or endophthalmitis .
-RESULTS	The incidence of nonocular SAEs was 8.8 % in the IAI group and 9.8 % in the laser group .
-RESULTS	One Anti-Platelet Trialists ' Collaboration-defined event of nonfatal stroke ( 1.1 % ) and 1 death ( 1.1 % ) due to pneumonia occurred during the 24 weeks of the study , both in patients in the laser group .
-CONCLUSIONS	Monthly IAI provided significantly greater visual benefit and reduction in CRT at 24 weeks than grid laser photocoagulation in eyes with macular edema after BRVO .
-
-###24962864
-BACKGROUND	Patients undergoing sleeve gastrectomy experience a significant amount of postoperative gastrointestinal ( GI ) symptoms .
-BACKGROUND	The purpose of our study was to assess the efficacy of omentopexy during laparoscopic sleeve gastrectomy ( LSG ) in reducing postoperative food intolerance and GI symptoms .
-METHODS	Morbidly obese patients undergoing LSG were randomly assigned to have LSG with or without omentopexy from May 2012 to June 2013 .
-METHODS	A total of 60 patients were recruited with 30 patients in each group .
-METHODS	Patients and the symptom scorer were blinded as to the assigned surgery .
-METHODS	All procedures were performed by one of two surgeons utilizing the same surgical technique .
-METHODS	Patients were administered standardized surveys , including the Rhodes Index survey , gastroesophageal reflux disease ( GERD ) impact survey , and Eating Assessment Tool ( EAT ) survey at various time points postoperatively to assess nausea , vomiting , retching , frequency of GI symptoms , and level of distress .
-RESULTS	There was no significant difference in patient age , percent decrease in BMI at any time point , or length of hospitalization between the two groups ( P > 0.05 ) .
-RESULTS	Furthermore , there was no significant difference in Rhodes Index scores , GERD impact scores , or EAT scores at any time point ( P > 0.05 ) .
-RESULTS	Patients in the LSG with omentopexy group required significantly more ondansetron perioperatively ( 16.1 12.9 mg vs. 10.3 10.2 mg , respectively ; P = 0.04 ) ; however , there was no difference in metoclopramide requirement ( P = 0.22 ) .
-RESULTS	Surgical morbidity was not significantly different between the two groups ( P > 0.05 ) .
-RESULTS	Finally , there was no significant difference in number of postoperative clinic visits , office telephone encounters , total postoperative readmissions , or postoperative readmissions associated with GI symptoms ( P > 0.05 ) .
-CONCLUSIONS	Omentopexy did not significantly decrease postoperative food intolerance or GI symptoms in morbidly obese patients undergoing LSG .
-CONCLUSIONS	Other methods of mitigating postoperative intolerance to oral intake and GI symptoms should be investigated .
-
-###24641742
-OBJECTIVE	The rehabilitation program after flexor tendon repair of zone II laceration varies .
-OBJECTIVE	We designed a Prospective Randomized Controlled Trial of controlled passive mobilization ( modified Kleinert ) vs. Place and active hold exercises after zone 2-flexor tendon repair by two-strand suture ( Modified kessler ) .
-METHODS	Sixty-four fingers in 54 patients with zone 2 flexor tendon modified Kessler repairs were enrolled in a prospective randomized controlled trial comparing place and active hold exercises to controlled passive mobilization ( modified Kleinert ) .
-METHODS	The primary outcome measure was total active motion eight weeks after repair as measured by an independent and blinded therapist .
-RESULTS	Patients treated with place and active hold exercises had significantly greater total active motion ( 146 ) eight weeks after surgery than patients treated with controlled passive mobilization ( 114 ) ( modified Klinert ) .
-RESULTS	There were no ruptures in either group .
-CONCLUSIONS	Place and hold achieves greater motion than controlled passive mobilization after a two-strand repair for zone 2 flexor tendon repairs .
-
-###25710763
-OBJECTIVE	To determine whether directly measured arterial blood pressure differs among anatomic locations and whether arterial blood pressure is influenced by body position .
-METHODS	33 client-owned dogs undergoing anesthesia .
-METHODS	Dogs undergoing anesthetic procedures had 20-gauge catheters placed in both the superficial palmar arch and the contralateral dorsal pedal artery ( group 1 [ n = 20 ] ) or the superficial palmar arch and median sacral artery ( group 2 [ 13 ] ) .
-METHODS	Dogs were positioned in dorsal recumbency , and mean arterial blood pressure ( MAP ) , systolic arterial blood pressure ( SAP ) , and diastolic arterial blood pressure ( DAP ) were recorded for both arteries 4 times ( 2-minute interval between successive measurements ) .
-METHODS	Dogs were positioned in right lateral recumbency , and blood pressure measurements were repeated .
-RESULTS	Differences were detected between pressures measured at the 2 arterial sites in both groups .
-RESULTS	This was especially true for SAP measurements in group 1 , in which hind limb measurements were a mean of 16.12 mm Hg higher than carpus measurements when dogs were in dorsal recumbency and 14.70 mm Hg higher than carpus measurements when dogs were in lateral recumbency .
-RESULTS	Also , there was significant dispersion about the mean for all SAP , DAP , and MAP measurements .
-CONCLUSIONS	Results suggested that arterial blood pressures may be dependent on anatomic location and body position .
-CONCLUSIONS	Because this may affect outcomes of studies conducted to validate indirect blood pressure measurement systems , care must be used when developing future studies or interpreting previous results .
-
-###25444803
-OBJECTIVE	This study was designed to identify the optimal dose of an MF59-adjuvanted , monovalent , A/H1N1 influenza vaccine in healthy paediatric subjects .
-METHODS	Subjects aged 3-8 years ( n = 194 ) and 9-17 years ( n = 160 ) were randomized to receive two primary doses of A/H1N1 vaccine containing either 3.75 g antigen with half a standard dose of MF59 adjuvant , 7.5 g antigen with a full dose of MF59 , or ( children 3-8 years only ) , a non-adjuvanted 15 g formulation .
-METHODS	A booster dose of MF59-adjuvanted seasonal influenza vaccine including homologous A/H1N1 strain was given one year after priming .
-METHODS	Immunogenicity was assessed by haemagglutination inhibition ( HI ) and microneutralization assays .
-METHODS	Vaccine safety was assessed throughout the study ( up to 18 months ) .
-RESULTS	A single priming dose of either MF59-adjuvanted formulation was sufficient to meet the European licensure criteria for pandemic influenza vaccines ( HI titres 1:40 > 70 % ; seroconversion > 40 % ; and GMR > 2.5 ) .
-RESULTS	Two non-adjuvanted vaccine doses were required to meet the same licensure criteria .
-RESULTS	After first and second doses , percentage of subjects with HI titres 1:40 were between 97 % and 100 % in the adjuvanted vaccine groups compared with 68 % and 91 % in the non-adjuvanted group , respectively .
-RESULTS	Postvaccination seroconversion rates ranged from 91 % to 98 % in adjuvanted groups and were 68 % ( first dose ) and 98 % ( second dose ) in the non-adjuvanted group .
-RESULTS	HI titres 1:330 after primary doses were achieved in 69 % to 90 % in adjuvanted groups compared with 41 % in the non-adjuvanted group .
-RESULTS	Long-term antibody persistence after priming and a robust antibody response to booster immunization were observed in all vaccination groups .
-RESULTS	All A/H1N1 vaccine formulations were generally well tolerated .
-RESULTS	No vaccine-related serious adverse events occurred , and no subjects were withdrawn from the study due to an adverse event .
-CONCLUSIONS	An MF59-adjuvanted influenza vaccine containing 3.75 g of A/H1N1 antigen was well tolerated and sufficiently immunogenic to meet all the European licensure criteria after a single dose in healthy children 3-17 years old .
-
-###24576316
-OBJECTIVE	To evaluate the analgesic potential of the centrally acting analgesics tramadol , morphine and the novel analgesic tapentadol in a pre-clinical research model of acute nociceptive pain , the tail-flick model in dogs .
-METHODS	Prospective part-randomized pre-clinical research trial .
-METHODS	Fifteen male Beagle dogs ( HsdCpb : DOBE ) , aged 12-15 months .
-METHODS	On different occasions separated by at least 1 week , dogs received intravenous ( IV ) administrations of tramadol ( 6.81 , 10.0 mg kg ( -1 ) ) , tapentadol ( 2.15 , 4.64 , 6.81 mg kg ( -1 ) ) or morphine ( 0.464 , 0.681 , 1.0 mg kg ( -1 ) ) with subsequent measurement of tail withdrawal latencies from a thermal stimulus ( for each treatment n = 5 ) .
-METHODS	Blood samples were collected immediately after the pharmacodynamic measurements of tramadol to determine pharmacokinetics and the active metabolite O-demethyltramadol ( M1 ) .
-RESULTS	Tapentadol and morphine induced dose-dependent antinociception with ED50-values of 4.3 mg kg ( -1 ) and 0.71 mg kg ( -1 ) , respectively .
-RESULTS	In contrast , tramadol did not induce antinociception at any dose tested .
-RESULTS	Measurements of the serum levels of tramadol and the M1 metabolite revealed only marginal amounts of the M1 metabolite , which explains the absence of the antinociceptive effect of tramadol in this experimental pain model in dogs .
-CONCLUSIONS	Different breeds of dogs might not or only poorly respond to treatment with tramadol due to low metabolism of the drug .
-CONCLUSIONS	Tapentadol and morphine which act directly on - opioid receptors without the need for metabolic activation are demonstrated to induce potent antinociception in the experimental model used and should also provide a reliable pain management in the clinical situation .
-CONCLUSIONS	The non-opioid mechanisms of tramadol do not provide antinociception in this experimental setting .
-CONCLUSIONS	This contrasts to many clinical situations described in the literature , where tramadol appears to provide useful analgesia in dogs for post-operative pain relief and in more chronically pain states .
-
-###24226381
-BACKGROUND	This paper describes a randomized prospective study conducted in 308 patients undergoing caesarean section in spinal anaesthesia at a single hospital between 2010 and 2012 to find a suitable anti-emetic strategy for these patients .
-METHODS	Spinal anesthesia was performed in left prone position , at L3/L4 with hyperbaric 0.5 % Bupivacaine according to a cc/cm body height ratio .
-METHODS	There were no opioids given peri-operatively .
-METHODS	The patients received either no prophylaxis ( Group I ) or tropisetron and metoclopramide ( Group II ) or dimenhydrinate and dexamethasone ( Group III ) , or tropisetron as a single medication ( Group IV ) .
-METHODS	The primary outcome was nausea and/or vomiting ( NV ) in the intraoperative , early ( 0-2 h ) or late ( 2-24 h ) postoperative period .
-METHODS	Multivariate statistical analysis was conducted with a regression analysis and a backward elimination of factors without significant correlation .
-RESULTS	All prophylactic agents significantly reduced NV incidence intraoperatively .
-RESULTS	Relative risk reduction for NV by prophylaxis was most effective ( 59.5 % ) in Group II ( tropisetron and metoclopramide ) .
-RESULTS	In Group III ( dimenhydrinate and dexamethasone ) , NV risk was reduced by 29.9 % and by 28.7 % in Group IV ( tropisetron mono-therapy ) .
-RESULTS	The incidence of NV in the early ( 0 ?
-RESULTS	2 h ) and the late ( 2 ?
-RESULTS	24 h ) postoperative period was low all over ( 7.8 % ) , but the relative risk reduction of NV in the early postoperative period was 54.1 % ( Group IV ) , 45.1 % ( Group III ) , and 34.8 % ( Group II ) , respectively .
-RESULTS	In the late postoperative period , there was no significant difference between the 4 groups .
-CONCLUSIONS	We recommend a prophylactic medication with tropisetron 2 mg and metoclopramide 20 mg for patients during caesarean section .
-CONCLUSIONS	These agents are safe , reasonably priced , and highly efficient in preventing nausea and vomiting .
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-###24999104
-OBJECTIVE	To explore whether topical application of atropine gel controls epiphora secondary to submandibular gland ( SMG ) transplantion for severe keratoconjunctivitis sicca .
-METHODS	Eighteen patients with epiphora after SMG transplantation participated in a double-blind , controlled , crossover study .
-METHODS	Patients were treated with topical smear common atropine ( CA ) and modified atropine ( MA ) gels ( intervals 1 day ) .
-METHODS	The control effect of atropine gels was observed for 5 hours .
-METHODS	Tear flow was quantified in resting and stimulated ( after exercise ) states using the Schirmer I test .
-RESULTS	With the CA gel , tear flow decreased significantly at 10 , 30 , and 120 minutes .
-RESULTS	Average epiphora reduction rates ( AERRs ) were 22.37 % , 18.14 % , and 13.27 % , respectively ( P < .05 ) .
-RESULTS	With the MA gel , tear flow decreased significantly from 5 minutes to 5 hours ; AERRs increased from 24.06 % to 42.67 % ( P < .05 ) ; Maximum efficacy was maintained from 15 minutes to 3 hours ( P < .01 ) ; Tear flow gradually increased from 4 to 5 hours but was still lower than that before atropine use ( P < .05 ) .
-RESULTS	According to results of the Schirmer I test and AERRs , the control efficacy of the MA gel was significantly better than that of the CA gel ( P < .05 ) .
-CONCLUSIONS	Topical application of atropine gel could effectively control mild epiphora for patients with SMG transplantation for severe keratoconjunctivitis sicca .
-CONCLUSIONS	The efficacy of MA gel was much better than that of the CA gel .
-
-###24811963
-OBJECTIVE	Eye drops of aganirsen , an antisense oligonucleotide preventing insulin receptor substrate-1 expression , inhibited corneal neovascularization in a previous dose-finding phase II study .
-OBJECTIVE	We aimed to confirm these results in a phase III study and investigated a potential clinical benefit on visual acuity ( VA ) , quality of life ( QoL ) , and need for transplantation .
-METHODS	Multicenter , double-masked , randomized , placebo-controlled phase III study .
-METHODS	Analysis of 69 patients with keratitis-related progressive corneal neovascularization randomized to aganirsen ( 34 patients ) or placebo ( 35 patients ) .
-METHODS	Patients applied aganirsen eye drops ( 86 g/day/eye ) or placebo twice daily for 90 days and were followed up to day 180 .
-METHODS	The primary end point was VA. .
-METHODS	Secondary end points included area of pathologic corneal neovascularization , need for transplantation , risk of graft rejection , and QoL .
-RESULTS	Although no significant differences in VA scores between groups were observed , aganirsen significantly reduced the relative corneal neovascularization area after 90 days by 26.20 % ( P = 0.014 ) .
-RESULTS	This improvement persisted after 180 days ( 26.67 % , P = 0.012 ) .
-RESULTS	Aganirsen tended to lower the transplantation need in the intent-to-treat ( ITT ) population at day 180 ( P = 0.087 ) .
-RESULTS	In patients with viral keratitis and central neovascularization , a significant reduction in transplantation need was achieved ( P = 0.048 ) .
-RESULTS	No significant differences between groups were observed in the risk of graft rejection .
-RESULTS	However , aganirsen tended to decrease this risk in patients with traumatic/viral keratitis ( P = 0.162 ) at day 90 .
-RESULTS	The QoL analyses revealed a significant improvement with aganirsen in composite and near activity subscores ( P = 0.039 and 0.026 , respectively ) at day 90 in the per protocol population .
-RESULTS	Ocular and treatment-related treatment-emergent adverse events ( TEAEs ) were reported in a lower percentage with aganirsen compared with placebo .
-RESULTS	Only 3 serious TEAEs ( 2 with aganirsen and 1 with placebo ) were considered treatment-related .
-CONCLUSIONS	This first phase III study on a topical inhibitor of corneal angiogenesis showed that aganirsen eye drops significantly inhibited corneal neovascularization in patients with keratitis .
-CONCLUSIONS	The need for transplantation was significantly reduced in patients with viral keratitis and central neovascularization .
-CONCLUSIONS	Topical application of aganirsen was safe and well tolerated .
-
-###24232133
-BACKGROUND	Structural learning theory suggests that experiencing motor task variation enables the central nervous system to extract general rules regarding tasks with a similar structure - rules that can subsequently be applied to novel situations .
-BACKGROUND	Complex minimally invasive surgery ( MIS ) requires different port sites , but switching ports alters the limb movements required to produce the same endpoint control of the surgical instrument .
-BACKGROUND	The purpose of the present study was to determine if structural learning theory can be applied to MIS to inform training methods .
-METHODS	A tablet laptop running bespoke software was placed within a laparoscopic box trainer and connected to a monitor situated at eye level .
-METHODS	Participants ( right-handed , non-surgeons , mean age = 23.2 years ) used a standard laparoscopic grasper to move between locations on the screen .
-METHODS	There were two training groups : the M group ( n = 10 ) who trained using multiple port sites , and the S group ( n = 10 ) who trained using a single port site .
-METHODS	A novel port site was used as a test of generalization .
-METHODS	Performance metrics were a composite of speed and accuracy ( SACF ) and normalized jerk ( NJ ; a measure of movement ` smoothness ' ) .
-RESULTS	The M group showed a statistically significant performance advantage over the S group at test , as indexed by improved SACF ( p < 0.05 ) and NJ ( p < 0.05 ) .
-CONCLUSIONS	This study has demonstrated the potential benefits of incorporating a structural learning approach within MIS training .
-CONCLUSIONS	This may have practical applications when training junior surgeons and developing surgical simulation devices .
-
-###24772521
-BACKGROUND	The Randomized Olmesartan and Diabetes Microalbuminuria Prevention ( ROADMAP ) study showed that 40 mg Olmesartan medoxomil ( OM ) versus placebo delayed microalbuminuria onset in patients with type 2 diabetes and normoalbuminuria .
-RESULTS	One thousand seven hundred and fifty-eight ROADMAP patients ( placebo arm : 877 ; OM arm : 881 ) participated in the observational follow up ( OFU ) with an average of 3.3 years .
-RESULTS	They received standard medical care and micro - and macrovascular events were documented .
-RESULTS	During observational follow-up 62.9 % and 60.1 % in the former OM and placebo group , respectively , received treatment with a RAS blocking agent .
-RESULTS	During the OFU period the systolic blood pressure ( SBP ) increased to mean values of 135 mm Hg in both groups .
-RESULTS	Patients who had developed microalbuminuria during ROADMAP had a higher incidence of cardio - and cerebrovascular events ( OR 1.77 , CI 1.03 to 3.03 , P = 0.039 ) during the OFU period compared with patients in whom this was not the case .
-RESULTS	Diabetic retinopathy was significantly reduced in the former OM group ( 8 [ 0.9 % ] versus 23 [ 2.6 % ] , OR : 0.34 , CI 0.15 to 0.78 , P = 0.011 ) and the rate of microalbuminuria was numerically reduced .
-RESULTS	Congestive heart failure requiring hospitalization ( 3 [ 0.3 % ] versus 12 [ 1.4 % ] , OR : 0.23 , CI 0.06 to 0.85 , P = 0.027 ) was reduced and there was a trend of reduced cardio - / cerebrovascular events ( OM versus Pb : 73 [ 8.3 % ] versus 86 [ 9.8 % ] patients ) .
-RESULTS	Seven ( 0.8 % ) deaths ( including 2 CV events ) were reported in former placebo patients versus 3 ( 0.3 % ) ( non-CV events ) in former OM patients .
-CONCLUSIONS	Development of microalbuminuria is a valid marker for future CV events .
-CONCLUSIONS	RAS blockade with Olmesartan might cause sustained reduction ( legacy effect ) of micro - and macrovascular events .
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-###25892679
-BACKGROUND	Early mobilisation after stroke is thought to contribute to the effects of stroke-unit care ; however , the intervention is poorly defined and not underpinned by strong evidence .
-BACKGROUND	We aimed to compare the effectiveness of frequent , higher dose , very early mobilisation with usual care after stroke .
-METHODS	We did this parallel-group , single-blind , randomised controlled trial at 56 acute stroke units in five countries .
-METHODS	Patients ( aged 18 years ) with ischaemic or haemorrhagic stroke , first or recurrent , who met physiological criteria were randomly assigned ( 1:1 ) , via a web-based computer generated block randomisation procedure ( block size of six ) , to receive usual stroke-unit care alone or very early mobilisation in addition to usual care .
-METHODS	Treatment with recombinant tissue plasminogen activator was allowed .
-METHODS	Randomisation was stratified by study site and stroke severity .
-METHODS	Patients , outcome assessors , and investigators involved in trial and data management were masked to treatment allocation .
-METHODS	The primary outcome was a favourable outcome 3 months after stroke , defined as a modified Rankin Scale score of 0-2 .
-METHODS	We did analysis on an intention-to-treat basis .
-METHODS	The trial is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN12606000185561 .
-RESULTS	Between July 18 , 2006 , and Oct 16 , 2014 , we randomly assigned 2104 patients to receive either very early mobilisation ( n = 1054 ) or usual care ( n = 1050 ) ; 2083 ( 99 % ) patients were included in the 3 month follow-up assessment .
-RESULTS	965 ( 92 % ) patients were mobilised within 24 h in the very early mobilisation group compared with 623 ( 59 % ) patients in the usual care group .
-RESULTS	Fewer patients in the very early mobilisation group had a favourable outcome than those in the usual care group ( n = 480 [ 46 % ] vs n = 525 [ 50 % ] ; adjusted odds ratio [ OR ] 073 , 95 % CI 059-090 ; p = 0004 ) .
-RESULTS	88 ( 8 % ) patients died in the very early mobilisation group compared with 72 ( 7 % ) patients in the usual care group ( OR 134 , 95 % CI 093-193 , p = 0113 ) .
-RESULTS	201 ( 19 % ) patients in the very early mobilisation group and 208 ( 20 % ) of those in the usual care group had a non-fatal serious adverse event , with no reduction in immobility-related complications with very early mobilisation .
-CONCLUSIONS	First mobilisation took place within 24 h for most patients in this trial .
-CONCLUSIONS	The higher dose , very early mobilisation protocol was associated with a reduction in the odds of a favourable outcome at 3 months .
-CONCLUSIONS	Early mobilisation after stroke is recommended in many clinical practice guidelines worldwide , and our findings should affect clinical practice by refining present guidelines ; however , clinical recommendations should be informed by future analyses of dose-response associations .
-BACKGROUND	National Health and Medical Research Council , Singapore Health , Chest Heart and Stroke Scotland , Northern Ireland Chest Heart and Stroke , UK Stroke Association , National Institute of Health Research .
-
-###26180474
-BACKGROUND	To assess the short-term efficacy and safety of corneal collagen cross-linking ( CXL ) in preventing the progression of keratoconus ( KCN ) .
-METHODS	This randomized controlled clinical trial enrolled 26 patients diagnosed with bilateral progressive KCN and were eligible for CXL .
-METHODS	In each patient , one eye was randomly selected for treatment , and the contralateral eye served as the control .
-METHODS	The patients underwent CXL with riboflavin drops and ultraviolet radiation in the treated eye .
-METHODS	One year follow-up data are presented .
-METHODS	Postoperatively , patients were assessed for progression of KCN , visual changes , and other findings .
-METHODS	The main outcome measures were maximum simulated keratometry ( K-max ) , best spectacle-corrected visual acuity ( BSCVA ) , and average simulated keratometry .
-METHODS	P < 0.05 was considered as statistically significant .
-RESULTS	In the treated eyes , the mean K-max values decreased by 0.22 D at 1-year postoperatively and increased by 0.41 D in the control group .
-RESULTS	This difference was statistically significant ( P < 0.001 ) .
-RESULTS	BSCVA improved slightly ( a decrease of 0.13 LogMAR ) and decreased slightly in the control group ( a 0.01 LogMAR increase ) .
-RESULTS	The difference between groups was statistically significant ( P = 0.014 ) .
-RESULTS	There was no decrease in visual acuity attributable to complications of CXL in the treated eyes .
-RESULTS	At 1-year , the keratometry in 3 ( 12 % ) treated eyes increased by more than 0.50 D and were considered cases of failed treatment .
-CONCLUSIONS	Preliminary and 1-year results indicate CXL can halt the progression of KCN in most cases without causing serious complications .
-
-###25311746
-BACKGROUND	We describe the organization of a prospective , randomized , multicenter trial comparing the effectiveness of open popliteal artery aneurysm repair ( OPAR ) and endovascular popliteal artery aneurysm repair ( EPAR ) of asymptomatic popliteal artery aneurysms ( PAAs ) as an example for how to use the Vascular Quality Initiative ( VQI ) framework .
-BACKGROUND	Given that many centers participate in the VQI , this model can be used to perform multicenters ' prospective trials on very modest budget .
-METHODS	VQI prospectively collects data on many vascular procedures .
-METHODS	These data include many important perioperative , intraoperative , and postoperative details regarding both patients and their procedures .
-METHODS	We describe a study where minimal changes to the collected data by participating centers can provide level-1 evidence regarding a significant clinical question .
-METHODS	Data will be collected using modified VQI forms within the existing VQI data reporting structure .
-METHODS	We plan to enroll 148 patients with asymptomatic PAAs into the open and endovascular surgery cohorts .
-METHODS	Patients from participating VQI centers will be randomized 1:1 to either OPAR or EPAR and will be followed for an average of 2.5 years .
-METHODS	Our primary hypothesis is that major adverse limb event-free survival is lower in the EPAR cohort and that EPAR is associated with more secondary interventions , improved quality of life , and decreased length of stay .
-METHODS	The budget for this trial is fixed at $ 10,000 / year for the course of the study , and the trial is judged to be feasible because of the functionality of the VQI platform .
-CONCLUSIONS	Using the existing VQI infrastructure , Open versus Endovascular Repair of Popliteal Artery Aneurysm will provide level 1 data for PAA treatment on a modest budget .
-CONCLUSIONS	The proposed trial has an adequately powered comparative design that will use objective performance goals to describe limb-related morbidity and procedural reintervention rates .
-
-###26182736
-BACKGROUND	Many minimally invasive interventional techniques as well as expectant treatment exist for the management of lower ureteric calculi .
-BACKGROUND	This study was conducted to evaluate th efficacy of tamsulosin as an expulsive pharmacologic therapy for the treatment of distal uretern stone .
-METHODS	This randomized control trial included 100 patients over 18 years of age wit stone Size > or = mm in distal 1/3 of ureter .
-METHODS	Patients were randomly assigned into two groups ( A & B Group A Patients were given Capsule Tamsulosin 0.4 mg , 1 daily up to 4 weeks while group B patients were given placebo , 1 Capsule daily up to 4 weeks .
-METHODS	The primary endpoint was expulsio rate .
-METHODS	A written informed consent was taken from all the patients .
-METHODS	Expulsion time , need for analgesics , need for hospitalization and drug side effects were secondary endpoints .
-RESULTS	A total of 49 patients in group A and 48 patients in group B reported back , therefore 97 out of 10 patients were evaluated .
-RESULTS	Mean age of the patients was 36.34 years ( range 18-57 years ) .
-RESULTS	Mea stone size was 5.78 mm ( range 4-8 mm ) in greatest dimension .
-RESULTS	A stone expulsion rate of 85.71 C ( 42 patients ) was noted in group A and 54.20 % ( 26 patients ) in group B. Group A revealed statistically significant advantage in term of stone expulsion rate ( p = 0.032 ) .
-RESULTS	Considering expulsio time in days group A showed statistically significant advantage ( p = 0.015 ) .
-RESULTS	Regarding age , se ) stone size and stone lateralization ( right/left ) , there was no significant difference between th group A and B. No drug side effects were noted in both the groups .
-CONCLUSIONS	By usin tamsulosin a higher stone expulsion rates can be achieved in a shorter time .
-CONCLUSIONS	More randomize control trials are required to establish tamsulosin as a standard medical expulsive treatment fc
-
-###24880345
-BACKGROUND	Despite improvements in liver surgery over the past decades , hemostasis during hepatic resections remains challenging .
-BACKGROUND	This multicenter randomized study compares the hemostatic effect of a collagen hemostat vs. a carrier-bound fibrin sealant after hepatic resection .
-METHODS	Patients scheduled for elective liver resection were randomized intraoperatively to receive either the collagen hemostat ( COLL ) or the carrier-bound fibrin sealant ( CBFS ) for secondary hemostasis .
-METHODS	The primary endpoint was the proportion of patients with hemostasis after 3 min .
-METHODS	Secondary parameters were the proportions of patients with hemostasis after 5 and 10 min , the total time to hemostasis , and the complication rates during a 3 months follow-up period .
-RESULTS	A total of 128 patients were included .
-RESULTS	In the COLL group , 53 out of 61 patients ( 86.9 % ) achieved complete hemostasis within 3 min after application of the hemostat compared to 52 out of 65 patients ( 80.0 % ) in the CBFS group .
-RESULTS	The 95 % confidence interval for this difference [ -6.0 % , 19.8 % ] does not include the lower noninferiority margin ( -10 % ) .
-RESULTS	Thus , the COLL treatment can be regarded as noninferior to the comparator .
-RESULTS	The proportions of patients with hemostasis after 3 , 5 , and 10 min were not significantly different between the two study arms .
-RESULTS	Postoperative mortality and morbidity were similar in both treatment groups .
-CONCLUSIONS	The collagen hemostat is as effective as the carrier-bound fibrin sealant in obtaining secondary hemostasis during liver resection with a comparable complication rate .
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-###24253758
-OBJECTIVE	Several studies emphasise that arabinoxylan and - glucan have more beneficial effects on glucose metabolism than low-dietary fibre ( DF ) meals .
-OBJECTIVE	Less attention has been paid to the effects of concentrated DF compared with whole grain .
-OBJECTIVE	We compared the effects of DF and whole grain on glucose , hormone responses and appetite in subjects with the metabolic syndrome ( MetS ) .
-METHODS	Fifteen subjects with MetS participated in this acute , randomised , cross-over intervention study .
-METHODS	The test breads provided 50 g of digestible carbohydrate : wheat bread with concentrated arabinoxylan ( AX ) or - glucan ( BG ) , rye bread with kernels ( RK ) and wheat bread ( WB ) as control .
-METHODS	Blood samples were drawn for 270 min to determine glucose , insulin , glucagon-like peptide-1 , glucose-dependent insulinotropic peptide ( GIP ) and ghrelin .
-METHODS	Appetite score was addressed every 30 min .
-METHODS	Ad libitum energy intake ( EI ) was measured 270 min after test meals .
-RESULTS	Compared with WB , BG and RK induced lower initial glycaemic responses ( P < 0.001 ) , whereas AX only reduced the glucose peak value ( P < 0.001 ) .
-RESULTS	RK reduced insulin ( P < 0.001 ) and GIP responses ( P < 0.001 ) compared with the other breads .
-RESULTS	BG lowered insulin responses more than AX ( P < 0.001 ) .
-RESULTS	AX , BG and RK increased satiety feeling ( P < 0.001 ) more than WB , but did not differ significantly in terms of subsequent EI ( P = 0.089 ) .
-CONCLUSIONS	BG and RK had beneficial impact on the glucose response , whereas AX had only effect on the postprandial glucose peak .
-CONCLUSIONS	The impact of the AX bread was influenced by higher protein content .
-CONCLUSIONS	Whether the metabolic effects of the breads are still present to mixed meals remains to be tested .
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-###24661511
-OBJECTIVE	To evaluate the clinical effect of proton pump inhibitor-based triple therapy combined with Saccharomyces boulardii in the treatment of Helicobacter pylori ( Hp ) infection among children in terms of Hp eradication rate and incidence of adverse events .
-METHODS	A prospective randomised controlled study was conducted on 240 children with a confirmed diagnosis of Hp infection .
-METHODS	These patients were randomized into triple therapy ( n = 120 ) and probiotics groups ( n = 120 ) .
-METHODS	The triple therapy group received amoxicillin [ 40mg / ( kgd ) , Tid ] , clarithromycin [ 15mg / ( kgd ) , Bid ] and omeprazole [ 0.7-0 .8 mg / ( kgd ) , Qd ] , while the probiotics group received Saccharomyces boulardii ( 250mg , Bid ) in addition to triple therapy .
-METHODS	The course of treatment was 14 days in both groups .
-METHODS	The adverse events in subjects were recorded by their parents during treatment .
-METHODS	Hp eradiation was evaluated by ( 13 ) C breath test at 4 weeks after treatment , and the eradication rate and incidence of adverse events were compared between the two groups .
-RESULTS	The Hp eradication rates were 75.8 % ( 91/120 ) in the triple therapy group and 85 % ( 102/120 ) in the probiotics group ( P > 0.05 ) .
-RESULTS	Compared with the triple therapy group , the probiotics group had nonsignificantly lower incidence of nausea , vomiting , and abdominal pain ( P > 0.05 ) and significantly lower incidence of stomatitis , constipation and diarrhea ( P < 0.05 ) .
-CONCLUSIONS	Triple therapy combined with Saccharomyces boulardii can not significantly increase Hp eradication rate , but can significantly reduce the incidence of stomatitis , constipation , and diarrhea during treatment .
-
-###25186922
-BACKGROUND	Little is known about the differences between standard-dose statins effects on glucose level and lipids in Japanese patients with diabetes mellitus ( DM ) .
-RESULTS	The 1,049 patients were randomly assigned to either the rosuvastatin group or atorvastatin group .
-RESULTS	There were no significant differences between the 2 groups in the effect on non-high-density lipoprotein cholesterol ( non-HDL-C ) and HbA1c at 12 months .
-RESULTS	However , physicians tended to switch to more intensive therapy for DM in the atorvastatin group .
-CONCLUSIONS	Rosuvastatin 5 mg and atorvastatin 10 mg have a similar lowering effect on non-HDL-C , but might be different in terms of adverse effect on glucose levels .
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-###24888929
-OBJECTIVE	Oral feeding is likely to have an impact on early return of normal bowel function after uncomplicated surgery including cesarean section .
-OBJECTIVE	This study compared postoperative outcomes of early versus late oral feeding regimes after cesarean section .
-METHODS	In this clinical trial , 140 pregnant women who underwent elective cesarean section with regional anesthesia were randomized into two feeding groups .
-METHODS	In the early oral and delayed oral feeding groups , liquid diets were commenced 2 and 8 h after surgery , respectively .
-METHODS	Patients able to tolerate the liquid diet were then gradually introduced to the regular diet .
-METHODS	Main clinical outcomes included duration of hospital stay , time to return of normal bowel function and postoperative gastrointestinal complications .
-RESULTS	Time to return of bowel movement ( 7.8 2.9 vs 11.7 5 h , P < 0.0001 ) and time to mobilization ( 10.7 7.7 vs 13.5 5.9 h , P = 0.015 ) occurred significantly earlier in the early feeding group .
-CONCLUSIONS	Early oral feeding reduces the time required for return of normal bowel function .
-CONCLUSIONS	This is without significant detrimental effects on the incidence of gastrointestinal complications .
-
-###25113132
-BACKGROUND	Hepatitis C virus ( HCV ) infection is common among prisoners , particularly those with a history of injecting drug use ( IDU ) .
-BACKGROUND	Incarcerated people who inject drugs frequently report high-risk injecting practices both in prison and in the community .
-BACKGROUND	In spite of rising morbidity and mortality , utilisation of HCV-related services in Australia has been persistently low .
-BACKGROUND	This study aimed to describe the incidence , prevalence and correlates of HCV seropositivity in a large cohort of prisoners who have injected drugs , and to identify correlates of receiving confirmation of active infection .
-METHODS	Data-linkage to a State-wide statutory notifiable diseases surveillance system was used to investigate the incidence of notified HCV seropositivity , seroconversion and confirmed HCV infection in a cohort of 735 prisoners with a history of IDU , over 14 years of follow up .
-METHODS	Hepatitis C test results from prison medical records were used to identify correlates of testing positive in prison .
-RESULTS	The crude incidence of HCV notification was 5.1 cases per 100 person-years .
-RESULTS	By the end of follow up , 55.1 % of the cohort had been the subject of a HCV-related notification , and 47.4 % of those tested in prison were HCV seropositive .
-RESULTS	In multivariable analyses , injecting in prison was strongly associated with HCV seropositivity , as was opioid use compared to injection of other drugs .
-RESULTS	The rate of reported diagnostic confirmation among those with notified infections was very low , at 6.6 confirmations per 100 seropositive participants per year .
-CONCLUSIONS	Injecting drugs in prison was strongly associated with HCV seropositivity , highlighting the need for increased provision of services to mitigate the risk of transmission within prisons .
-CONCLUSIONS	Once identified as seropositive through screening , people with a history of IDU and incarceration may not be promptly receiving diagnostic services , which are necessary if they are to access treatment .
-CONCLUSIONS	Improving access to HCV-related services will be of particular importance in the coming years , as HCV-related morbidity and mortality is increasing , and next generation therapies are becoming more widely available .
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-###24747867
-OBJECTIVE	Data comparing the efficacy and safety of combination therapy with peginterferon plus low-dose ribavirin and peginterferon monotherapy in treatment-naive haemodialysis patients with hepatitis C virus genotype 2 ( HCV-2 ) infection are limited .
-METHODS	In this randomised trial , 172 patients received 24weeks of peginterferon alfa-2a 135g/week plus ribavirin 200mg/day ( n = 86 ) or peginterferon alfa-2a 135g/week ( n = 86 ) .
-METHODS	The efficacy and safety endpoints were sustained virological response ( SVR ) rate and adverse event ( AE ) - related withdrawal rate .
-RESULTS	Compared with monotherapy , combination therapy had a greater SVR rate ( 74 % vs 44 % , relative risk ( RR ) : 1.68 [ 95 % CI 1.29 to 2.20 ] ; p < 0.001 ) .
-RESULTS	The beneficial effect of combination therapy was more pronounced in patients with baseline viral load 800,000 IU/mL than those with baseline viral load < 800,000 IU/mL ( RR : 3.08 [ 95 % CI 1.80 to 5.29 ] vs. RR : 1.11 [ 95 % CI 0.83 to 1.45 ] ; interaction p = 0.001 ) .
-RESULTS	Patients receiving combination therapy were more likely to have a haemoglobin level of < 8.5 g/dL ( 70 % vs. 8 % , risk difference ( RD ) : 62 % [ 95 % CI 50 % to 73 % ] ; p < 0.001 ) and required a higher dosage [ mean : 13,417 vs. 6667 IU/week , p = 0.027 ] of epoetin to manage anaemia than those receiving monotherapy .
-RESULTS	The AE-related withdrawal rates were 6 % and 3 % in combination therapy and monotherapy groups , respectively ( RD : 2 % [ 95 % CI -4 % to 9 % ] ) .
-CONCLUSIONS	In treatment-naive haemodialysis patients with HCV-2 infection , combination therapy with peginterferon plus low-dose ribavirin achieved a greater SVR rate than peginterferon monotherapy .
-CONCLUSIONS	Most haemodialysis patients can tolerate combination therapy .
-BACKGROUND	ClinicalTrial.gov number , NCT00491244 .
-
-###24661672
-OBJECTIVE	The secreted protein acidic and rich in cysteine-like 1 ( SPARCL1 ) is expressed in various normal tissues and many types of cancers .
-OBJECTIVE	The function of SPARCL1 and its relationship to a patient 's prognosis have been studied , whereas its relationship to radiation therapy ( RT ) is not known .
-OBJECTIVE	Our aim was to investigate the expression of SPARCL1 in rectal cancer patients who participated in a clinical trial of preoperative RT. .
-METHODS	The study included 136 rectal cancer patients who were randomized to undergo preoperative RT and surgery ( n = 63 ) or surgery alone ( n = 73 ) .
-METHODS	The expression levels of SPARCL1 in normal mucosa ( n = 29 ) , primary tumor ( n = 136 ) , and lymph node metastasis ( n = 35 ) were determined by immunohistochemistry .
-RESULTS	Tumors with RT had stronger SPARCL1 expression than tumors without RT ( P = .003 ) .
-RESULTS	In the RT group , strong SPARCL1 expression was related to better survival than weak expression in patients with stage III tumors , independent of sex , age , differentiation , and margin status ( P = .022 ; RR = 18.128 ; 95 % confidence interval , 1.512-217 .413 ) .
-RESULTS	No such relationship was found in the non-RT group ( P = .224 ) .
-RESULTS	Further analysis of interactions among SPARCL1 expression , RT , and survival showed statistical significance ( P = .024 ) .
-RESULTS	In patients with metastases who received RT , strong SPARCL1 expression was related to better survival compared to weak expression ( P = .041 ) but not in the non-RT group ( P = .569 ) .
-CONCLUSIONS	SPARCL1 expression increases with RT and is related to better prognosis in rectal cancer patients with RT but not in patients without RT. .
-CONCLUSIONS	This result may help us to select the patients best suited for preoperative RT. .
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-###25168034
-BACKGROUND	Relatively few treatment programs have been developed specifically for smokeless tobacco ( ST ) users who want to quit .
-BACKGROUND	Their results suggest that self-help materials , telephone counseling , and nicotine lozenges are efficacious .
-BACKGROUND	This study provides the first direct examination of the separate and combined effects of telephone counseling and lozenges .
-METHODS	We recruited ST users online ( N = 1067 ) and randomly assigned them to 1 of 3 conditions : ( a ) a lozenge group ( n = 356 ) , who were mailed 4-mg nicotine lozenges ; ( b ) a coach calls group ( n = 354 ) , who were offered 3 coaching phone calls ; or ( c ) a lozenge + coach calls group ( N = 357 ) , who received both lozenges and coaching calls .
-METHODS	Additionally , all participants were mailed self-help materials .
-METHODS	Self-reported tobacco abstinence was assessed at 3 and 6 months after randomization .
-RESULTS	Complete-case and intention-to-treat ( ITT ) analyses for all tobacco abstinence were performed at 3 months , 6 months , and both 3 and 6 months ( repeated point prevalence ) .
-RESULTS	ITT analyses revealed a highly similar result : the lozenge + coach calls condition was significantly more successful in encouraging tobacco abstinence than either the lozenge group or the coach calls group , which did not differ .
-CONCLUSIONS	Combining nicotine lozenges and phone counseling significantly increased tobacco abstinence rates compared with either intervention alone , whereas coach calls and lozenges were equivalent .
-CONCLUSIONS	The study confirms the high tobacco abstinence rates for self-help ST cessation interventions and offers guidance to providing tobacco treatment to ST users .
-
-###26079800
-BACKGROUND	The authors conducted a randomized , controlled , parallel-arm , superiority study to test the hypothesis that a continuous adductor canal block decreases the time to attain four discharge criteria compared with a continuous femoral nerve block after tricompartment knee arthroplasty .
-METHODS	Subjects undergoing tricompartment knee arthroplasty were randomized using computer-generated lists to either an adductor canal or femoral perineural catheter ( 3-day ropivacaine 0.2 % infusion ) in an unmasked manner .
-METHODS	The primary outcome was the time to attain four criteria : ( 1 ) adequate analgesia ; ( 2 ) intravenous opioids independence ; ( 3 ) ability to stand , walk 3 m , return , and sit down ; and ( 4 ) ambulate 30 m.
-RESULTS	Subjects with an adductor canal catheter ( n = 39 ) reached all four criteria in a median of 55h ( interquartile , 42 to 63h ) compared with 61h ( 49 to 69h ) for those with a femoral catheter ( n = 41 ; 95 % CI , -13 to 1h ; P = 0.12 ) .
-RESULTS	The percentage of subjects who reached the two mobilization criteria on postoperative days 1 and 2 were 72 and 95 % for those with an adductor canal catheter ( n = 39 ) , but only 27 and 76 % in subjects with a femoral catheter ( n = 41 ; both P < 0.001 ) .
-RESULTS	Differences in pain scores at rest and intravenous opioid requirements were minimal , but femoral infusion improved dynamic analgesia ( P = 0.01 to 0.02 ) .
-CONCLUSIONS	Compared with a continuous femoral nerve block , a continuous adductor canal block did not appreciably decrease the time to overall discharge readiness even though it did decrease the time until adequate mobilization , primarily because both groups experienced similar analgesia and intravenous opioid requirements that -- in most cases -- exceeded the time to mobilization .
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-###24535654
-BACKGROUND	To our knowledge , only a few double-blind randomized controlled trials with antipsychotic drugs have been conducted to examine the treatment of methamphetamine-induced psychosis ( MAP ) .
-OBJECTIVE	The aims of this study are to compare the antipsychotic and adverse events of quetiapine , an atypical antipsychotic drug , to haloperidol , a standard treatment for primary psychotic disorder , in individuals with MAP .
-METHODS	Eighty individuals with MAP were randomly assigned into two groups , i.e. treatment with quetiapine ( n = 36 ) and haloperidol ( n = 44 ) .
-METHODS	Sixty-eight patients ( 85 % ) completed the study protocol , i.e. treatment with quetiapine at least 100 mg per day or haloperidol at least 2 mg per day orally once a day for 4 weeks .
-METHODS	The doses were increased every 5 days until no psychotic symptom was observed from the Positive and Negative Syndrome Scale ( PANSS ) .
-METHODS	Data were analysed by survival analysis with Cox 's proportional regression analysis , general estimating equations and log-rank tests .
-RESULTS	Thirty-two ( 89 % ) subjects from the quetiapine group and 37 subjects ( 84 % ) from the haloperidol group met the remission criteria at the end of the study .
-RESULTS	Baseline PANSS total scores of quetiapine and haloperidol groups were 82.4 16.6 and 90.0 18.4 , respectively ( mean SD ; p = 0.06 ) .
-RESULTS	The change-from-baseline scores were -47.8 for the quetiapine group and -53.2 for the haloperidol group .
-RESULTS	There were no significant differences between the antipsychotic effects ( coefficient value = -2.6 , p = 0.32 , 95 % CI = -7.6 , 2.5 ) and the adverse effects of quetiapine and haloperidol .
-CONCLUSIONS	Quetiapine may be used as an antipsychotic treatment for MAP with comparable therapeutic effects and adverse events to treatment with classical antipsychotic drugs .
-
-###24433609
-BACKGROUND	Despite the important role that health professionals have in reducing tobacco use , many have a smoking habit themselves .
-BACKGROUND	The prevalence of smoking is particularly high among nurses .
-OBJECTIVE	To test the efficacy , acceptability and feasibility of a motivational interviewing ( MI ) based smoking cessation intervention with nurses .
-METHODS	Two group parallel experimental design with random allocation to groups .
-METHODS	A large teaching hospital in the North of Spain .
-METHODS	Nurses who smoked ( n = 30 ) were randomised into two groups : motivational interviewing based intervention ( n = 15 ) and usual care ( n = 15 ) .
-METHODS	Motivational interviewing based intervention consisted of four individual MI sessions .
-METHODS	Usual care consisted of brief advice .
-METHODS	Variables considered to assess efficacy were biochemically verified smoking cessation , mean cigarettes smoked , stages of change , self-efficacy and depression score .
-METHODS	Variables to assess acceptability and feasibility included participant satisfaction , adherence to MI , and duration of sessions .
-METHODS	Data were collected at : baseline , end of intervention and three months after the end of the intervention .
-RESULTS	At three month follow up , compared with the control group , more nurses in the intervention group had quit ( absolute difference 33.3 % ; 95 % confidence interval [ CI ] 2.6-58 .2 ) .
-RESULTS	In the nurses who did not quit , there was no significant difference between the intervention and control groups in the number of cigarettes smoked per day , although progress in the stages of change was greater in the intervention group compared to the control group .
-RESULTS	Measures of acceptability and feasibility indicated good satisfaction with the intervention , with high levels of attendance and completion .
-CONCLUSIONS	This study found a beneficial effect of motivational interviewing on nurses ' smoking cessation .
-CONCLUSIONS	The intervention was acceptable for nurses and a number of aspects were identified that need to be considered prior to conducting a larger scale in order to optimise the intervention .
-CONCLUSIONS	Using MI might be a novel approach to the problem of health professionals who smoke .
-
-###24787302
-BACKGROUND	The traditional treatment after closed reduction of distal radius ( DR ) and distal both bone ( DBB ) forearm fractures has been application of a long-arm cast ( LAC ) or a short-arm cast ( SAC ) .
-BACKGROUND	Splinting is another option that avoids the potential complications associated with casting .
-BACKGROUND	The purpose of this study is to evaluate the maintenance of reduction of DR or DBB fractures placed in a double-sugar-tong splint ( DSTS ) compared with a LAC in a pediatric population .
-METHODS	This is an IRB-approved , prospective , randomized trial .
-METHODS	Patients aged 4 to 12 years with DR or DBB fractures treated at a single institution between 2010 and 2012 were enrolled .
-METHODS	After reduction , fractures were placed into either a LAC or a DSTS .
-METHODS	Radiographs were reviewed at initial injury , postreduction , and at set intervals for angulation , displacement , and apposition , as well as cast index and 3-point index .
-METHODS	The DSTS was overwrapped into a cast after week 1 .
-METHODS	The immobilization device was changed to a SAC at week 4 or 6 .
-METHODS	Total duration of immobilization was 6 to 8 weeks .
-RESULTS	Seventy-one patients were enrolled with 37 in the LAC and 34 in the DSTS .
-RESULTS	Average age was 8.73 years ( range , 4 to 12 ) with 43 being males .
-RESULTS	There were 28 isolated DR and 43 DBB fractures .
-RESULTS	There were no week-to-week differences between the 2 groups in regards to sagittal alignment , coronal alignment , apposition , or displacement .
-RESULTS	Sagittal alignment at immediate postreduction and week 2 showed that the DSTS was slightly better ( average 2.0 vs. 5.0 degrees , respectively , P = 0.04 ) .
-RESULTS	For the entire treatment period there was an increased risk of loss of reduction of 10 degrees in the LAC group versus the DSTS group ( 7 patients vs. 2 patients , respectively , P = 0.0001 ) , and of meeting the criteria for remanipulation ( 10 patients vs. 5 patients , respectively , P = 0.01 ) .
-RESULTS	At cast removal , there was no difference between groups .
-CONCLUSIONS	Although there were significant differences between the 2 groups with regards to risk of reduction loss , the DSTS and LAC were comparable in maintenance of reduction at the time of cast removal .
-CONCLUSIONS	Both the DSTS and LAC are appropriate immobilization devices for these pediatric fractures .
-METHODS	Level II-prospective , comparative study .
-
-###25459392
-BACKGROUND	Pancreatic ductal adenocarcinoma ( PDAC ) is one of the most common malignant tumours and is still associated with a poor prognosis in advanced disease .
-BACKGROUND	To improve the standard therapy with gemcitabine , we initiated a prospective randomised phase-II trial with gemcitabine ( GEM ) versus gemcitabine plus sunitinib ( SUNGEM ) based on data of in vitro trials and phase-I data for the combination treatment .
-BACKGROUND	The rational of adding sunitinib was its putative antiangiogenic mechanism of action .
-METHODS	A total of 106 eligible patients with locally advanced , unresectable or metastatic PDAC without previous system therapy were randomised to receive GEM at a dosage of 1.000 mg/m ( 2 ) d1 , 8 , 15 q28 versus a combination of SUNGEM at a dosage of GEM 1.000 mg/m ( 2 ) d1 +8 and sunitinib 50mg p.o. d1-14 , q21d .
-METHODS	The primary end-point was progression free survival ( PFS ) , secondary end-points were overall survival ( OS ) , toxicity and overall response rate ( ORR ) .
-RESULTS	The confirmatory analysis of PFS was based on the intend-to-treat ( ITT ) population ( N = 106 ) .
-RESULTS	The median PFS was 13.3 weeks ( 95 % confidence interval ( 95 % - CI ) : 10.4-18 .1 weeks ) for GEM and 11.6 weeks for SUNGEM ( 95 % - CI : 7.0-18 .0 weeks ; p = 0.78 one-sided log-rank ) .
-RESULTS	The ORR was 6.1 % ( 95 % - CI : 0.7-20 .2 % ) for GEM and for 7.1 % ( 95 % - CI : 0.9-23 .5 % ) for SUNGEM ( p = 0.87 ) .
-RESULTS	The median time to progression ( TTP ) was 14.0 weeks ( 95 % - CI : 12.4-22 .3 weeks ) for GEM and 18.0 weeks ( 95 % - CI : 11.3-19 .3 weeks ) for SUNGEM ( p = 0.60 ; two-sided log-rank ) .
-RESULTS	The median OS was 36.7 weeks ( 95 % - CI : 20.6-49 .0 weeks ) for the GEM arm and 30.4 weeks ( 95 % - CI : 18.1-37 .6 weeks ) for the SUNGEM ( p = 0.78 , one-sided log-rank ) .
-RESULTS	In regard to toxicities , suspected SAEs were reported in 53.7 % in the GEM arm and 71.2 % in the SUNGEM arm .
-RESULTS	Grade 3 and 4 neutropenia was statistically significantly higher in the SUNGEM arm with 48.1 % versus 27.8 % in the GEM arm ( p = 0.045 , two sided log-rank ) .
-CONCLUSIONS	The combination SUNGEM was not sufficient superior in locally advanced or metastatic PDAC compared to GEM alone in regard to efficacy but was associated with more toxicity .
-
-###24427279
-BACKGROUND	DHA is accumulated in the central nervous system ( CNS ) before birth and is involved in early developmental processes , such as neurite outgrowth and gene expression .
-OBJECTIVE	To determine whether fetal DHA insufficiency occurs and constrains CNS development in term gestation infants .
-METHODS	A risk reduction model using a randomized prospective study of term gestation single birth healthy infants born to women ( n = 270 ) given a placebo or 400 mg/day DHA from 16 wk gestation to delivery .
-METHODS	Fetal DHA deficiency sufficient to constrain CNS development was assessed based on increased risk that infants in the placebo group would not achieve neurodevelopment scores in the top quartile of all infants in the study .
-RESULTS	Infants in the placebo group were at increased risk of lower language development assessed as words understood ( OR 3.22 , CL 1.49-6 .94 , P = 0.002 ) and produced ( OR 2.61 , CL 1.22-5 .58 , P = 0.01 ) at 14 mo , and words understood ( OR 2.77 , CL 1.23-6 .28 , P = 0.03 ) and sentences produced ( OR 2.60 , CL 1.15-5 .89 , P = 0.02 ) at 18 mo using the McArthur Communicative Developmental Inventory ; receptive ( OR 2.23 , CL 1.08-4 .60 , P = 0.02 ) and expressive language ( OR 1.89 , CL 0.94-3 .83 , P = 0.05 ) at 18 mo using the Bayley Scales of Infant Development III ; and visual acuity ( OR 2.69 , CL 1.10-6 .54 , P = 0.03 ) at 2 mo. .
-BACKGROUND	ClinicalTrials.gov NCT00620672 .
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-###24886786
-BACKGROUND	Although screening , brief intervention , and referral to treatment ( SBIRT ) has shown promise for alcohol use , relatively little is known about its effectiveness for adult illicit drug use .
-BACKGROUND	This randomized controlled trial assessed the effectiveness of the SBIRT approach for outcomes related to drug use among patients visiting trauma and emergency departments ( EDs ) at two large , urban hospitals .
-METHODS	A total of 700 ED patients who admitted using illegal drugs in the past 30days were recruited , consented , provided baseline measures of substance use and related problems measured with the Addiction Severity Index-Lite ( ASI-Lite ) , and then randomized to the Life Shift SBIRT intervention or to an attention-placebo control group focusing on driving and traffic safety ( Shift Gears ) .
-METHODS	Both groups received a level of motivational intervention matched to their condition and risk level by trained paraprofessional health educators .
-METHODS	Separate measurement technicians conducted face-to-face follow-ups at 6months post-intervention and collected hair samples to confirm reports of abstinence from drug use .
-METHODS	The primary outcome measure of the study was past 30-day drug abstinence at 6months post-intervention , as self-reported on the ASI-Lite .
-RESULTS	Of 700 participants , 292 ( 42 % ) completed follow-up .
-RESULTS	There were no significant differences in self-reported abstinence ( 12.5 % vs. 12.0 % , p = 0.88 ) for Life Shift and Shift Gears groups , respectively .
-RESULTS	When results of hair analyses were applied , the abstinence rate was 7 percent for Life Shift and 2 percent for Shift Gears ( p = .074 ) .
-RESULTS	In an analysis in which results were imputed ( n = 694 ) , there was no significant difference in the ASI-Lite drug use composite scores ( Life Shift +0.005 vs. Shift Gears +0.017 , p = 0.12 ) .
-CONCLUSIONS	In this randomized controlled trial , there was no evidence of effectiveness of SBIRT on the primary drug use outcome .
-BACKGROUND	ClinicalTrials.gov NCT01683227 .
-
-###25544955
-OBJECTIVE	This study aimed to compare the effects of different local anesthetic solutions on postoperative pain of anal surgery in adult patients .
-METHODS	In this randomized double-blind prospective clinical trial , 60 adult patients ( 18 to 60 years old ) with physical status class I and class II that had been brought to a university hospital operating room for fistula anal surgery with spinal anesthesia were selected .
-METHODS	Patients were randomly divided into 4 equal groups according to table of random numbers ( created by Random Allocation Software 1 ) .
-METHODS	Group 1 received 3 mL of normal saline , group 2 , 1 mL of normal saline plus 2 mL of bupivacaine 0.5 % , group 3 , 1 mL of ketamine plus 2 mL of bupivacaine 0.5 % , and group 4 , no infiltration .
-METHODS	Intensity of pain in patients was measured using visual analogue scale ( VAS ) at 0 ( transfer to ward ) , 2 , 6 , 12 , and 24 hours after surgery .
-METHODS	Time interval to administration of drugs and overall dose of drugs were measured in 4 groups .
-RESULTS	Mean level of pain was the lowest in group 3 at all occasions with a significant difference , followed by groups 2 , 4 , and lastly 1 ( P < 0.001 ) .
-RESULTS	Furthermore , groups 2 and 3 compared to groups 1 and 4 had the least overall dose of analgesics and requested them the latest , with a significant difference ( P < 0.05 ) .
-CONCLUSIONS	Local anesthesia ( 1 mL of ketamine plus 2 mL of bupivacaine 0.5 % or 1 mL of normal saline plus 2 mL of bupivacaine 0.5 % ) combined with spinal anesthesia reduces postoperative pain and leads to greater comfort in recovering patients .
-
-###25481336
-OBJECTIVE	This study investigated inter-rater agreement ( IRA ) among EEG experts for the identification of electrographic seizures and periodic discharges ( PDs ) in continuous ICU EEG recordings .
-METHODS	Eight board-certified EEG experts independently identified seizures and PDs in thirty 1-h EEG segments which were selected from ICU EEG recordings collected from three medical centers .
-METHODS	IRA was compared between seizure and PD identifications , as well as among rater groups that have passed an ICU EEG Certification Test , developed by the Critical Care EEG Monitoring Research Consortium ( CCEMRC ) .
-RESULTS	Both kappa and event-based IRA statistics showed higher mean values in identification of seizures compared to PDs ( k = 0.58 vs. 0.38 ; p < 0.001 ) .
-RESULTS	The group of rater pairs who had both passed the ICU EEG Certification Test had a significantly higher mean IRA in comparison to rater pairs in which neither had passed the test .
-CONCLUSIONS	IRA among experts is significantly higher for identification of electrographic seizures compared to PDs .
-CONCLUSIONS	Additional instruction , such as the training module and certification test developed by the CCEMRC , could enhance this IRA .
-CONCLUSIONS	This study demonstrates more disagreement in the labeling of PDs in comparison to seizures .
-CONCLUSIONS	This may be improved by education about standard EEG nomenclature .
-
-###24494804
-BACKGROUND	The aim of this study was to comparatively evaluate three different stabilization methods with regards to the amount of shrinkage in free gingival graft .
-METHODS	Forty-five patients were included in three study groups : where stabilization was achieved with conventional technique , cyanoacrylate or microsurgery .
-METHODS	In the conventional group standardized 5-0 sutures were used .
-METHODS	In the microsurgery group grafts were stabilized with 7-0 sutures and loupe .
-METHODS	In the third group , graft was stabilized with cyanoacrylate .
-METHODS	Keratinized tissue width , graft area , gingival recession were calculated by a specific software on standard photographs at baseline , 1 - , 3 - , 6-month follow-ups .
-METHODS	Duration of surgery was also recorded .
-METHODS	Pain in recipient and donor sites was assessed using visual analogue scale within the first postoperative week .
-RESULTS	Change in keratinized tissue width was similar in the study groups at all times .
-RESULTS	Graft shrinkage was significantly less ( p < 0.05 ) in the cyanoacrylate group than the other groups , whereas those in the conventional and microsurgery groups were similar .
-RESULTS	Significantly less pain in the recipient site was reported by the patients in the cyanoacrylate group ( p < 0.05 ) .
-RESULTS	Duration of surgery was significantly less in the cyanoacrylate group than the other groups ( p < 0.05 ) .
-CONCLUSIONS	Less graft shrinkage in the free gingival graft , together with shorter surgery time and less pain in the recipient site obtained in the cyanoacrylate group , suggest that cyanoacrylate may be considered as an alternative for stabilization of free gingival grafts .
-
-###26001320
-OBJECTIVE	ECAR ( Endovasculaire ou Chirurgie dans les Anvrysmes aorto-iliaques Rompus ) is a prospective multicentre randomized controlled trial including consecutive patients with ruptured aorto-iliac aneurysms ( rAIA ) eligible for treatment by either endovascular ( EVAR ) or open surgical repair ( OSR ) .
-OBJECTIVE	Inclusion criteria were hemodynamic stability and computed tomography scan demonstrating aorto-iliac rupture .
-METHODS	Randomization was done by week , synchronously in all centers .
-METHODS	The primary end point was 30 day mortality .
-METHODS	Secondary end points were post-operative morbidity , length of stay in the intensive care unit ( ICU ) , amount of blood transfused ( units ) and 6 month mortality .
-RESULTS	From January 2008 to January 2013 , 107 patients ( 97 men , 10 women ; median age 74.4 years ) were enrolled in 14 centers : 56 ( 52.3 % ) in the EVAR group and 51 ( 47.7 % ) in the OSR group .
-RESULTS	The groups were similar in terms of age , sex , consciousness , systolic blood pressure , Hardman index , IGSII score , type of rupture , use of endoclamping balloon , and levels of troponin , creatinine , and hemoglobin .
-RESULTS	Delay to treatment was higher in the EVAR group ( 2.9 vs. 1.3 hours ; p < .005 ) .
-RESULTS	Mortality at 30 days and 1 year were not different between the groups ( 18 % in the EVAR group vs. 24 % in the OSR group at 30 days , and 30 % vs. 35 % , respectively , at 1 year ) .
-RESULTS	Total respiratory support time was lower in the EVAR group than in the OSR group ( 59.3 hours vs. 180.3 hours ; p = .007 ) , as were pulmonary complications ( 15.4 % vs. 41.5 % , respectively ; p = .050 ) , total blood transfusion ( 6.8 vs. 10.9 , respectively ; p = .020 ) , and duration of ICU stay ( 7 days vs. 11.9 days , respectively ; p = .010 ) .
-CONCLUSIONS	In this study , EVAR was found to be equal to OSR in terms of 30 day and 1 year mortality .
-CONCLUSIONS	However , EVAR was associated with less severe complications and less consumption of hospital resources than OSR .
-
-###24602409
-BACKGROUND	Interferon ( IFN ) - therapy for chronic hepatitis C virus infection is frequently associated with depression .
-BACKGROUND	The routine prophylaxis with antidepressants might expose patients to adverse effects , hence , the need for alternative preventive interventions .
-BACKGROUND	Omega-3 polyunsaturated fatty acids are safe and effective essential nutritional compounds used for the treatment of depression , putatively through an anti-inflammatory action .
-BACKGROUND	In addition , lower erythrocyte levels of omega-3 polyunsaturated fatty acids have been associated with an increased risk of IFN-induced depression .
-METHODS	We conducted a 2-week , double-blind , placebo-controlled trial comparing eicosapentaenoic acid ( EPA ) , docosahexaenoic acid ( DHA ) , and placebo for the prevention of IFN -- induced depression .
-METHODS	A total of 162 patients consented to participate and were randomized to the study .
-METHODS	All of the patients completed the 2-week trial ; 152 participants were followed throughout the 24 weeks of IFN - treatment and were included in the analysis .
-RESULTS	Compared with placebo , the incident rates of IFN -- induced depression were significantly lower in EPA-treated but not in DHA-treated patients ( 10 % and 28 % , respectively , versus 30 % for placebo , p = .037 ) .
-RESULTS	Both EPA and DHA significantly delayed the onset of IFN-induced depression ( week of onset : 12.0 and 11.7 , respectively , versus 5.3 for placebo , p = .002 ) .
-RESULTS	EPA and DHA were both well tolerated in this population .
-RESULTS	EPA treatment increased both EPA and DHA erythrocyte levels , but DHA only increased DHA erythrocyte levels .
-CONCLUSIONS	EPA is effective in the prevention of depression in hepatitis C virus patients received IFN - therapy .
-CONCLUSIONS	Our study confirms the notion that anti-inflammatory strategies are effective antidepressants in the context of depression associated with inflammation .
-
-###25727586
-BACKGROUND	Some children have residual amblyopia after treatment with atropine eyedrops for amblyopia due to strabismus and/or anisometropia .
-BACKGROUND	We conducted a randomized clinical trial to evaluate the effectiveness of augmenting the effect of atropine by changing the lens over the fellow eye to plano in children with residual amblyopia .
-METHODS	A total of 73 children 3 to < 8 years of age ( mean , 5.8 years ) with stable residual amblyopia ( range , 20/32 to 20/160 , mean 20/63 ( +1 ) ) were enrolled after at least 12 weeks of atropine treatment of the fellow eye .
-METHODS	Participants were randomly assigned to continuing weekend atropine alone or wearing a plano lens over the fellow eye ( while continuing atropine ) .
-METHODS	The primary outcome was assessed at 10 weeks , and participants were followed until improvement ceased .
-RESULTS	At the 10-week primary outcome visit , amblyopic-eye visual acuity had improved an average of 1.1 lines with the plano lens and 0.6 lines with atropine only ( difference adjusted for baseline visual acuity = + 0.5 line ; 95 % CI , -0.1 to +1.2 ) .
-RESULTS	At the primary outcome or later visit when the best-measured visual acuity was observed , the mean amblyopic-eye improvement from baseline was 1.9 lines with the plano lens and 0.8 lines with atropine only .
-CONCLUSIONS	When amblyopic-eye visual acuity stops improving with atropine treatment , there may be a small benefit to augmenting atropine therapy with a plano lens over the fellow eye .
-CONCLUSIONS	However , the effect was not statistically significant , and the large confidence interval raises the possibility of no benefit or a benefit larger than we observed .
-CONCLUSIONS	A larger study would be necessary to get a more precise estimate of the treatment effect .
-
-###24915914
-OBJECTIVE	To assess the efficacy and safety of heated humidified high-flow nasal cannula ( HHHFNC ) ventilation compared with nasal continuous positive airway pressure ( NCPAP ) on prevention of extubation failure in the NICUs .
-METHODS	A prospective randomized , controlled un-blinded study was conducted in 12 tertiary hospitals in Hebei Province from December 1 , 2012 to May 31 , 2013 .
-METHODS	Neonates were eligible for this study if they were admitted to the participating NICUs within 7 days of postnatal age , and needed noninvasive respiratory support after a period of mechanical ventilation with an endotracheal tube .
-METHODS	Infants were randomly assigned to either HHHFNC or NCPAP group .
-METHODS	The primary outcome measures included : the incidence of extubation failure , bronchopulmonary dysplasia and the mortality before discharge .
-RESULTS	Among the 255 cases included , 128 were in the HHHFNC group , and 127 were in the NCPAP group .
-RESULTS	There was no significant difference in gestational age , birth weight , and age at randomization , and male/female ratio between the two groups ( P > 0.05 ) .
-RESULTS	There were no significant differences between groups for days on ventilation , noninvasive respiratory support , oxygen requirement , hospital stay and time to full oral feedings ( P > 0.05 ) .
-RESULTS	The overall mortality of the studied population was 10.6 % ( 27/255 ) .
-RESULTS	The occurrence of extubation failure within 7 days was 9.4 % whereas 29.0 % in very low birth weight infants .
-RESULTS	There was no significant difference in the extubation failure for HHHFNC ( 12/128 , 9.4 % ) versus NCPAP ( 12/127 , 9.4 % ) ( P > 0.05 ) , or in mortality for HHHFNC ( 12/128 , 9.4 % ) versus NCPAP ( 15/127 , 11.8 % ) ( P > 0.05 ) .
-RESULTS	No significant difference was found between the study groups in the occurrence of bronchopulmonary dysplasia ( BPD ) and most of severe adverse outcomes analyzed , including air leak syndrome and nasal trauma .
-RESULTS	The occurrence of abdominal distention during treatment was higher in NCPAP than HHHFNC group ( 12.6 % vs. 5.5 % , P < 0.05 ) .
-CONCLUSIONS	Among infants 7 d of postnatal age , HHHFNC appears to have efficacy and safety similar to those of NCPAP group when applied immediately post-extubation to prevent extubation failure .
-CONCLUSIONS	Despite concerns on unmonitored pressure delivery during HHHFNC support , no increase of the occurrence of BPD , air leak syndrome or mortality was found .
-
-###24561752
-BACKGROUND	Randomized trials found that use of erythropoiesis-stimulating agents to target normal hematocrit ( Hct ) levels ( > 39 % ) compared with 27 % -34.5 % increases cardiovascular risk and mortality among chronic kidney disease patients .
-BACKGROUND	However , the effects of the most widely used Hct target in the past 2 decades , 34.5 % -39 % , have never been examined .
-OBJECTIVE	To compare the effects of 2 Hct target strategies-30 .0 % -34.5 % ( low ) and 34.5 % -39.0 % ( mid ) in a high-risk population : elderly dialysis patients with significant comorbidities .
-METHODS	Observational data from the US Renal Data System were used to emulate a randomized trial in which patients were assigned to either Hct strategy .
-METHODS	Follow-up started after completing 3 months of hemodialysis and ended 6 months later .
-METHODS	We conducted the observational analogs of intention-to-treat and per-protocol analyses .
-METHODS	Inverse-probability weighting was used to adjust for measured time-dependent confounding by indication .
-METHODS	A total of 22,474 elderly patients with both diabetes and cardiovascular disease who initiated hemodialysis in 2006-2008 .
-METHODS	Hazard ratios ( HRs ) and survival probabilities for all-cause mortality and a composite cardiovascular and mortality endpoint .
-RESULTS	The intention-to-treat HR ( 95 % confidence interval ) for mid versus low Hct strategy was 1.05 ( 0.99-1 .11 ) for all-cause mortality and 1.03 ( 0.98-1 .08 ) for the composite endpoint .
-RESULTS	The per-protocol HR ( 95 % confidence interval ) for mid versus low Hct strategy was 0.98 ( 0.78-1 .24 ) for all-cause mortality and 1.00 ( 0.81-1 .24 ) for the composite outcome .
-CONCLUSIONS	Among hemodialysis patients , we did not find differences in 6-month survival or cardiovascular risk between clinical strategies that target Hct at 30.0 % -34.5 % versus 34.5 % -39.0 % .
-
-###24885486
-BACKGROUND	Few cancers pose greater challenges than head and neck ( H&N ) cancer .
-BACKGROUND	Residual effects following treatment include body image changes , pain , fatigue and difficulties with appetite , swallowing and speech .
-BACKGROUND	Depression is a common comorbidity .
-BACKGROUND	There is limited evidence about ways to assist patients to achieve optimal adjustment after completion of treatment .
-BACKGROUND	In this study , we aim to examine the effectiveness and feasibility of a model of survivorship care to improve the quality of life of patients who have completed treatment for H&N cancer .
-METHODS	This is a preliminary study in which 120 patients will be recruited .
-METHODS	A prospective randomised controlled trial of the H&N Cancer Survivor Self-management Care Plan ( HNCP ) involving pre - and post-intervention assessments will be used .
-METHODS	Consecutive patients who have completed a defined treatment protocol for H&N cancer will be recruited from two large cancer services and randomly allocated to one of three study arms : ( 1 ) usual care , ( 2 ) information in the form of a written resource or ( 3 ) the HNCP delivered by an oncology nurse who has participated in manual-based training and skill development in patient self-management support .
-METHODS	The trained nurses will meet patients in a face-to-face interview lasting up to 60 minutes to develop an individualised HNCP , based on principles of chronic disease self-management .
-METHODS	Participants will be assessed at baseline , 3 and 6 months .
-METHODS	The primary outcome measure is quality of life .
-METHODS	The secondary outcome measures include mood , self-efficacy and health-care utilisation .
-METHODS	The feasibility of implementing this intervention in routine clinical care will be assessed through semistructured interviews with participating nurses , managers and administrators .
-METHODS	Interviews with patients who received the HNCP will explore their perceptions of the HNCP , including factors that assisted them in achieving behavioural change .
-CONCLUSIONS	In this study , we aim to improve the quality of life of a patient population with unique needs by means of a tailored self-management care plan developed upon completion of treatment .
-CONCLUSIONS	Delivery of the intervention by trained oncology nurses is likely to be acceptable to patients and , if successful , will be a model of care that can be implemented for diverse patient populations .
-BACKGROUND	ACTRN12613000542796 ( registered on 15 May 2013 ) .
-
-###25359924
-BACKGROUND	Antiviral therapy with interferon-alpha ( IFN - ) for hepatitis C virus ( HCV ) infection is associated with increased risk for depression .
-OBJECTIVE	To identify clinical predictors for IFN -- induced depression during antiviral therapy for HCV infection .
-METHODS	Depression ( defined with the Montgomery-sberg Depression Rating Scale ( MADRS ) ) was evaluated before and during antiviral treatment in 91 people with chronic HCV infection without a history of psychiatric disorders .
-METHODS	Cognitive function was evaluated using the Trail Making Test A/B ( TMT A/B ) .
-METHODS	( Trial registration at ClinicalTrials.gov : NCT00136318 . )
-RESULTS	Depression during antiviral therapy was significantly associated with a baseline MADRS score of 3 or higher ( P = 0.006 ) .
-RESULTS	In total , 89 % ( n = 16 ) of patients who had a baseline score > 0 for the single item sadness developed depression .
-RESULTS	Poor baseline performance in the TMT A ( P = 0.027 ) and TMT B ( P = 0.033 ) was predictive for severe depression .
-CONCLUSIONS	Pre-treatment screening for subthreshold depressive and cognitive symptoms will help to identify those at risk for IFN -- associated depression among patients with chronic hepatitis C.
-
-###25194996
-OBJECTIVE	To study the effects of closure vs nonclosure of buccal mucosal graft harvest site .
-METHODS	Patients were randomized to either primary closure or nonclosure of buccal mucosal harvest site during urethroplasty .
-METHODS	Graft widths were standardized to 2 cm .
-METHODS	Prospective data were collected via patient visual analog scales ( 0-10 ) of 5 domains examining pain , numbness , tightness , drinking , and eating at postoperative day 1 and 3 and then at 3 weeks and 3 months until 1 year .
-RESULTS	There were 34 patients who underwent randomization and completed the study .
-RESULTS	The preoperative demographics between both groups were comparable with no significant differences .
-RESULTS	The median age is 44 years .
-RESULTS	There were 16 patients in the closure group and 18 patients in the nonclosure group .
-RESULTS	The results show an improvement in the domains of pain ( P = .08 ) , drinking ( P = .06 ) , and eating ( P = .03 ) in favor of the closure group at postoperative day 1 and 3 .
-RESULTS	There are no significant differences in all 5 domains between both groups after 3 weeks postoperatively
-CONCLUSIONS	This study shows that primary closure of buccal mucosal graft bed improves pain as well as oral intake in the immediate postoperative period .
-CONCLUSIONS	There are no long-term differences .
-
-###25271389
-BACKGROUND	Uncertainty exists about the most effective route for delivery of early nutritional support in critically ill adults .
-BACKGROUND	We hypothesized that delivery through the parenteral route is superior to that through the enteral route .
-METHODS	We conducted a pragmatic , randomized trial involving adults with an unplanned admission to one of 33 English intensive care units .
-METHODS	We randomly assigned patients who could be fed through either the parenteral or the enteral route to a delivery route , with nutritional support initiated within 36 hours after admission and continued for up to 5 days .
-METHODS	The primary outcome was all-cause mortality at 30 days .
-RESULTS	We enrolled 2400 patients ; 2388 ( 99.5 % ) were included in the analysis ( 1191 in the parenteral group and 1197 in the enteral group ) .
-RESULTS	By 30 days , 393 of 1188 patients ( 33.1 % ) in the parenteral group and 409 of 1195 patients ( 34.2 % ) in the enteral group had died ( relative risk in parenteral group , 0.97 ; 95 % confidence interval , 0.86 to 1.08 ; P = 0.57 ) .
-RESULTS	There were significant reductions in the parenteral group , as compared with the enteral group , in rates of hypoglycemia ( 44 patients [ 3.7 % ] vs. 74 patients [ 6.2 % ] ; P = 0.006 ) and vomiting ( 100 patients [ 8.4 % ] vs. 194 patients [ 16.2 % ] ; P < 0.001 ) .
-RESULTS	There were no significant differences between the parenteral group and the enteral group in the mean number of treated infectious complications ( 0.22 vs. 0.21 ; P = 0.72 ) , 90-day mortality ( 442 of 1184 patients [ 37.3 % ] vs. 464 of 1188 patients [ 39.1 % ] , P = 0.40 ) , in rates of 14 other secondary outcomes , or in rates of adverse events .
-RESULTS	Caloric intake was similar in the two groups , with the target intake not achieved in most patients .
-CONCLUSIONS	We found no significant difference in 30-day mortality associated with the route of delivery of early nutritional support in critically ill adults .
-CONCLUSIONS	( Funded by the United Kingdom National Institute for Health Research ; CALORIES Current Controlled Trials number , ISRCTN17386141 . )
-
-###24556911
-OBJECTIVE	To evaluate the effect of the intravenous ( i.v. ) L-alanyl-L-glutamine dipeptide supplementation during 5 days on clinical outcome in trauma patients admitted to the intensive care unit ( ICU ) .
-METHODS	This was a prospective , randomized , double-blind , multicenter trial .
-METHODS	Glutamine was not given as a component of nutrition but as an extra infusion .
-METHODS	The primary outcome variable was the number of new infections within the first 14 days .
-RESULTS	We included 142 patients .
-RESULTS	There were no differences between groups in baseline characteristics .
-RESULTS	Up to 62 % of the patients in the placebo group and 63 % in the treatment group presented confirmed infections ( p = 0.86 ) .
-RESULTS	ICU length of stay was 14 days in both groups ( p = 0.54 ) .
-RESULTS	Hospital length of stay was 27 days in the placebo group and 29 in the treatment group ( p = 0.88 ) .
-RESULTS	ICU mortality was 4.2 % in both groups ( p = 1 ) .
-RESULTS	Sixty percent of the patients presented low glutamine levels before randomization .
-RESULTS	At the end of the treatment ( 6th day ) , 48 % of the patients maintained low glutamine levels ( 39 % of treated patients vs. 57 % in the placebo group ) .
-RESULTS	Patients with low glutamine levels at day 6 had more number of infections ( 58.8 vs. 80.9 % ; p = 0.032 ) and longer ICU ( 9 vs. 20 days ; p < 0.01 ) and hospital length of stay ( 24 vs. 41 days ; p = 0.01 ) .
-CONCLUSIONS	There was no benefit with i.v. L-alanyl-L-glutamine dipeptide supplementation ( 0.5 g/kg body weight/day of the dipeptide ) during 5 days in trauma patients admitted to the ICU .
-CONCLUSIONS	The i.v. glutamine supplementation was not enough to normalize the plasma glutamine levels in all patients .
-CONCLUSIONS	Low plasma glutamine levels at day 6 were associated with a worse outcome .
-
-###24708818
-BACKGROUND	Dietary sodium restriction is a key management strategy in chronic kidney disease ( CKD ) .
-BACKGROUND	Recent evidence has demonstrated short-term reduction in blood pressure ( BP ) and proteinuria with sodium restriction , however the effect on other cardiovascular-related risk factors requires investigation in CKD .
-METHODS	The LowSALT CKD study involved 20 hypertensive Stage III-IV CKD patients counselled by a dietitian to consume a low-sodium diet ( < 100mmol/day ) .
-METHODS	The study was a randomised crossover trial comparing 2weeks of high-sodium ( additional 120mmol sodium tablets ) and low-sodium intake ( placebo ) .
-METHODS	Measurements were taken after each crossover arm including BP ( peripheral and central ) , adipokines ( inflammation markers and adiponectin ) , volume markers ( extracellular-to-intracellular [ E/I ] fluid ratio ; N-terminal pro-brain natriuretic peptide [ NT-proBNP ] ) , kidney function ( estimated Glomerular Filtration Rate [ eGFR ] ) and proteinuria ( urine protein-creatinine ratio [ PCR ] and albumin-creatinine ratio [ ACR ] ) .
-METHODS	Outcomes were compared using paired t-test for each cross-over arm .
-RESULTS	BP-lowering benefits of a low-sodium intake ( peripheral BP ( meanSD ) 148/8221/12mmHg ) from high-sodium ( 159/8715/10mmHg ) intake were reflected in central BP and a reduction in eGFR , PCR , ACR , NTproBNP and E/I ratio .
-RESULTS	There was no change in inflammatory markers , total or high molecular weight adiponectin .
-CONCLUSIONS	Short-term benefits of sodium restriction on BP were reflected in significant change in kidney function and fluid volume parameters .
-CONCLUSIONS	Larger , long-term adequately powered trials in CKD are necessary to confirm these results .
-BACKGROUND	Universal Trial Number U1111-1125-2149 registered on 13/10/2011 ; Australian New Zealand Clinical Trials Registry Number ACTRN12611001097932 registered on 21/10/2011 .
-
-###24337884
-BACKGROUND	Endoscopic submucosal dissection ( ESD ) is a standard treatment for gastric neoplasia limited to the mucosa without lymph node metastasis .
-BACKGROUND	However , there are neither standardized guidelines nor studies on the best time to start oral intake after ESD .
-BACKGROUND	The aim of this study was to compare patient satisfaction , safety , length of hospital stay , and economic feasibility between an early post-ESD diet and the conventional immediate fasting protocol .
-METHODS	A total of 130 patients with 156 gastric epithelial neoplasias who underwent ESD by a single expert endoscopist were consecutively and prospectively enrolled .
-METHODS	Enrolled patients were randomized to an early diet group or a control group .
-METHODS	The early diet group started meals as a clear liquid diet on day 0 , and a soft diet and general diet in sequence on day 1 .
-METHODS	The fasting group was fasted for 2 days .
-METHODS	Patients in both groups underwent second-look endoscopy within 2 days following ESD and follow-up endoscopy after 2 months .
-RESULTS	In the course of the study , ten patients were excluded .
-RESULTS	The total number of patients in the early diet group and control group was 63 and 57 , respectively .
-RESULTS	Mean age was 62 years ( 9.4 ) .
-RESULTS	There were no significant differences in clinicopathologic conditions or endoscopic results such as procedure time or size of lesions between the two groups .
-RESULTS	There were no significant differences in abdominal pain score , rate of post-ESD bleeding or healing rate of ESD-induced ulcer between the two groups .
-RESULTS	However , the early diet protocol led to significantly higher patient satisfaction ( p = 0.001 ) , lower hospital costs ( p < 0.001 ) , and shorter hospital stay ( p < 0.001 ) than the conventional fasting protocol .
-CONCLUSIONS	An early post-ESD diet protocol provides higher patient satisfaction , is more cost effective , decreases hospital stay , and does not influence complication rates such as post-ESD bleeding , abdominal pain , or ulcer healing compared with the conventional fasting protocol .
-
-###25351025
-BACKGROUND	Internet-based applications are becoming more common in our modern world .
-BACKGROUND	While electronic health records ( EHR ) are available for patients and health care providers outside of Germany , most of the available data on EHR address only monetary advantages.This study explores whether or not internet-based communication between family physicians ( FP ) and patients is as safe as traditional oral communication and if it may lead to further benefits .
-METHODS	500 patients from 14 family doctors ' offices were included in this 6 months RCT .
-METHODS	Both groups were treated in the same manner by their respective physicians , but members of the study group ( SG ) were able to access an individual developed web-based software where they could view their diagnosis and medication , and send an electronic message to their doctors who would respond .
-METHODS	Their satisfication with the FP , certain health data and the FP 's workload were recorded .
-RESULTS	a ) Patients ' satisfaction : When e.g. asked about the organization of the family practice or trust in the doctor , there were no significant differences between the control ( CG ) and the SG ( p = 0.07 ; p = 0.53 ) .
-RESULTS	However , patients of the SG felt better informed ( p = 0.01 ) , and generally more satisfied with their FP ( p = 0.04 ) .
-RESULTS	b ) FP workload : Members of the CG had 8.44 contacts with their doctors during the study , while the SG only had 7.96 recorded contacts ( including web-based contacts , p = 0.32 ) .
-RESULTS	It took physicians 3:52 minutes less to read and respond to an electronic message than to see a patient during the consultation hours .
-RESULTS	c ) Changes in patients ' health : During the study the blood pressure ( BP ) in the CG rose 4.44 / 2.80 mmHg , while it dropped 3.13 / 4.36 mmHg in the SG ( p = 0.19 / 0.01 ) .
-RESULTS	The HbA ( 1C ) dropped in both groups ( p = 0.91 ) .
-RESULTS	One week after the first visit to the family doctor , patients of the SG rated their pain 0.28 points lower on a VAS than the CG ( p = 0.75 ) .
-RESULTS	91 % from the CG and 96 % from the SG requested the re-prescription of long-term medication on time ( p = 0.16 ) .
-CONCLUSIONS	Using an optional web-based communication platform is as safe as traditional consultations can be .
-CONCLUSIONS	Both patients and doctors may benefit from using the internet in this context .
-
-###24472665
-BACKGROUND	Many transfusion services are keeping thawed plasma ( TP ) ready for trauma patients .
-BACKGROUND	According to Chinese guidelines , once thawed , fresh frozen plasma ( FFP ) should be used within 24h .
-BACKGROUND	This may increase plasma wastage and delay plasma administration to critical patients .
-BACKGROUND	However , it can be avoided by being relabeled as TP .
-BACKGROUND	In this study we evaluated coagulation-related proteins in thawed apheresis FFP during 5 days of storage at 1-6 C.
-METHODS	Thirty apheresis fresh plasma units were aliquot and stored at -70 C. Aliquots were thawed at 37 C and stored at 1-6 C for 0 , 1 , 2 , 3 , 4 and 5 days , respectively .
-METHODS	Prothrombin time ( PT ) , activated partial thromboplastin time ( aPTT ) , thrombin time ( TT ) , fibrinogen ( Fbg ) , factor ( F ) II , FV , FVII , FVIII , FIX , FX , FXI , FXII , protein C ( PC ) , protein S ( PS ) , antithrombin III ( ATIII ) and ADAMTS13 levels were assessed at Days 0-5 , respectively .
-RESULTS	For 5 days of refrigerated storage , no significant differences were observed in Fbg , PC , PS , ATIII and ADAMTS13 .
-RESULTS	FII , FV , FVII , FVIII , FIX , FX , FXI and FXII declined significantly over time .
-RESULTS	The storage presented major decrease for FVIII , with a drop of 40 % .
-RESULTS	However , at least 60 % levels of all measured proteins were remained on Day 5 , when compared to Day 0 .
-CONCLUSIONS	All measured proteins in TP for 5 days of refrigerated storage were adequate .
-CONCLUSIONS	These could provide evidence that thawed FFP could be relabeled as TP , which is a potential to ensure rapid plasma availability in emergency situations in China .
-
-###26521576
-OBJECTIVE	To explore the clinical efficacy and safety of acupuncture and moxibustion for copracrasia .
-METHODS	By prospective live randomized controlled trial , 40 cases with copracrasia were randomly divided into an acupuncture-moxibustion group and a medication group , 20 cases in each one .
-METHODS	In the acupuncture-moxibustion group , acupuncture was applied at Ciliao ( BL 32 ) , Changqiang ( GV 1 ) and Tianshu ( ST 25 ) and mild moxibustion was used at Qihai ( CV 6 ) .
-METHODS	Treatment was given for 12 weeks and 32 times , 3 times a week in the front 8 weeks , 2 times a week in the latter 4 weeks .
-METHODS	In the medication group , conventional symptomatic treatment , support therapy , and complications preventing and treating were adopted for 12 weeks .
-METHODS	Anal incontinence score ( Vaizey incontinence score ) , effective rate and self-rating score for satisfaction were observed before and after treatment and in the follow-up period .
-RESULTS	After 12 weeks ' treatment in the two groups , Vaizey incontinence ' scores were both decreased ( both P < 0.05 ) , and after treatment and in the follow-up period the scores in the acupuncture-moxibustion group were lower than those in the corresponding period in the medication group ( both P < 0.05 ) .
-RESULTS	The effective rate of the acupuncture-moxibustion group was 80.0 % ( 16/20 ) , which was statistically different from 50.0 % ( 10/20 ) in the medication group ( P < 0.05 ) .
-RESULTS	The effective rate in the follow-up period of the acupuncture-moxibustion group was 90.0 % ( 18/20 ) and it was not statistically different from 80.0 % ( 16/20 ) in the medication group ( P > 0.05 ) .
-RESULTS	The self-rating scores for satisfaction in the acupuncture-moxibustion group were superior to those in the medication group after treatment and in the follow-up period ( both P < 0.05 ) .
-CONCLUSIONS	Acupuncture and moxibustion could improve copracrasia and the acupuncture-moxibustion rules and characteristics for the disorder should be paid attention to in the further research .
-
-###25380743
-BACKGROUND	Potential benefits of single-port laparoscopic surgery may include improved cosmetic results , less postoperative pain , surgical trauma and faster recovery .
-BACKGROUND	Results of randomized prospective studies with a focus on single-port rectal surgery have not yet been presented .
-BACKGROUND	The aim of the present study was to compare single-port and conventional laparoscopic surgery for rectal cancer in terms of short-term outcomes including postoperative pain and trauma-induced changes in certain bioactive substances .
-METHODS	Patients with non-metastasized rectal cancer were prospectively randomized to single-port ( n = 20 ) or conventional laparoscopic rectal surgery ( n = 20 ) .
-METHODS	Postoperative pain was assessed at rest , at coughing and during mobilization , with a numeric pain ranking score and was recorded at 6 h after the operation and subsequently every morning daily for 4 days .
-METHODS	Levels of C-reactive protein ( CRP ) , interleukin-6 ( IL-6 ) and tissue inhibitor of metalloproteinases-1 ( TIMP-1 ) were determined .
-METHODS	Blood samples were collected preoperatively ( baseline ) , and 6 , 24 , 48 , 72 and 96 h after skin incision .
-RESULTS	Pain scores were significantly reduced in the single-port group on postoperative days 2 , 3 and 4 during coughing and mobilization .
-RESULTS	In addition , the patients in the single-port group suffered significantly less pain at rest at 6 h after surgery and on postoperative days 1 , 3 and 4 .
-RESULTS	The levels of the three markers increased significantly after surgery .
-RESULTS	The increase was similar between groups for plasma IL-6 and TIMP-1 at all time points , while the CRP levels were significantly lower in the single-port group at 6 ( p < 0.001 ) and 24 h ( p < 0.05 ) after skin incision .
-RESULTS	Abdominal incisions lengths were significantly shorter in the single-port group ( p = 0.001 ) .
-RESULTS	There was no significant difference between groups in operating time and blood loss , morbidity or mortality rate .
-RESULTS	The short-term oncological outcome in the two groups was similar .
-CONCLUSIONS	Single-port rectal surgery may reduce postoperative pain .
-CONCLUSIONS	Although CRP levels were lower at some time points , results of the present randomized , pilot study suggest that the trauma-induced inflammatory response of single-port operations may be similar to the trauma-induced inflammatory response of conventional laparoscopic surgery .
-
-###24594421
-OBJECTIVE	To compare in dual-energy CT ( DECT ) conventionally reconstructed polyenergetic images ( PEI ) at 120 kVp to virtual monoenergetic images ( MEI ) at different kiloelectron volt ( keV ) levels for evaluation of liver and gastrointestinal stromal tumor ( GIST ) hepatic metastases with regard to objective ( IQob ) and subjective image quality ( IQsub ) assessed by two readers of varying experience .
-OBJECTIVE	Image quality was correlated to patient size and compared between PEI and MEI .
-METHODS	From 50 examinations of 17 GIST patients ( 12 with hepatic metastases ) undergoing abdominal dual-source DECT for staging , therapy monitoring or follow-up , PEI and nine MEI in 10-keV intervals from 40 to 120 keV were reconstructed .
-METHODS	Liver contrast-to-noise ratios ( CNR ) and metastasis-to-liver ratios were calculated .
-METHODS	MEI reconstructions with the highest IQob were compared to PEI for IQsub by one experienced reader ( ER ) and one inexperienced reader ( IR ) .
-METHODS	Patients ' diameters were correlated to IQob and IQsub ratings .
-RESULTS	MEI at 70 keV had the highest IQob with equal liver CNR and metastasis-to-liver ratio compared to PEI .
-RESULTS	The ER rated 70-keV MEI and PEI equally high ( median 4 ) , whereas the IR rated IQsub best in 70-keV MEI ( median 5 ) .
-RESULTS	Unlike in PEI , IQsub ratings in 70-keV MEI were not correlated to patient size .
-CONCLUSIONS	MEI at 70 keV provided an IQob equivalent to PEI .
-CONCLUSIONS	Regarding the IR , IQsub was improved in 70-keV MEI compared to PEI and less dependent on patient size .
-CONCLUSIONS	Therefore , IRs might improve their diagnostic confidence in the assessment of hepatic GIST metastases by evaluating MEI reconstructions at 70 keV .
-
-###24488608
-OBJECTIVE	Current stroke risk schemes need improvement of predictive value in patients with atrial fibrillation .
-OBJECTIVE	Transoesophageal echocardiography ( TEE ) may facilitate stroke risk assessment in such patients and guide antithrombotic treatment .
-METHODS	We randomised 238 patients with non-valvular atrial fibrillation and a moderate stroke risk to aspirin or adjusted vitamin K antagonist therapy after TEE had ruled out thrombogenic features in the atria and aorta .
-METHODS	The primary outcome was a composite of stroke , major bleeding , peripheral embolism and all-cause mortality .
-RESULTS	Mean CHA2DS2-VASc score was 2.11.1 .
-RESULTS	The incidences of the composite primary outcome at a mean follow-up of 1.6 years were 3.2 % ( 2.02 % per year ) in the aspirin group compared to 6.1 % ( 3.84 % per year ) in the vitamin K antagonists group with an absolute advantage of 2.9 percentage points .
-RESULTS	Aspirin was non-inferior to vitamin K antagonists ( p < 0.0001 ) because the upper limit of the 90 % CI did not exceed the 7 % absolute difference in event rate between the two treatment arms .
-CONCLUSIONS	This hypothesis-generating pilot trial has found that TEE may be used for refinement of stroke risk in paroxysmal atrial fibrillation patients .
-CONCLUSIONS	A larger trial is needed to confirm these data .
-CONCLUSIONS	( ClinicalTrials.gov number NTC00224757 ) .
-
-###24736370
-BACKGROUND	Insecticide-treated nets ( ITNs ) and indoor residual spraying ( IRS ) of houses provide effective malaria transmission control .
-BACKGROUND	There is conflicting evidence about whether it is more beneficial to provide both interventions in combination .
-BACKGROUND	A cluster randomised controlled trial was conducted to investigate whether the combination provides added protection compared to ITNs alone .
-RESULTS	In northwest Tanzania , 50 clusters ( village areas ) were randomly allocated to ITNs only or ITNs and IRS .
-RESULTS	Dwellings in the ITN+IRS arm were sprayed with two rounds of bendiocarb in 2012 .
-RESULTS	Plasmodium falciparum prevalence rate ( PfPR ) in children 0.5-14 y old ( primary outcome ) and anaemia in children < 5 y old ( secondary outcome ) were compared between study arms using three cross-sectional household surveys in 2012 .
-RESULTS	Entomological inoculation rate ( secondary outcome ) was compared between study arms .
-RESULTS	IRS coverage was approximately 90 % .
-RESULTS	ITN use ranged from 36 % to 50 % .
-RESULTS	In intention-to-treat analysis , mean PfPR was 13 % in the ITN+IRS arm and 26 % in the ITN only arm , odds ratio = 0.43 ( 95 % CI 0.19-0 .97 , n = 13,146 ) .
-RESULTS	The strongest effect was observed in the peak transmission season , 6 mo after the first IRS .
-RESULTS	Subgroup analysis showed that ITN users were additionally protected if their houses were sprayed .
-RESULTS	Mean monthly entomological inoculation rate was non-significantly lower in the ITN+IRS arm than in the ITN only arm , rate ratio = 0.17 ( 95 % CI 0.03-1 .08 ) .
-CONCLUSIONS	This is the first randomised trial to our knowledge that reports significant added protection from combining IRS and ITNs compared to ITNs alone .
-CONCLUSIONS	The effect is likely to be attributable to IRS providing added protection to ITN users as well as compensating for inadequate ITN use .
-CONCLUSIONS	Policy makers should consider deploying IRS in combination with ITNs to control transmission if local ITN strategies on their own are insufficiently effective .
-CONCLUSIONS	Given the uncertain generalisability of these findings , it would be prudent for malaria control programmes to evaluate the cost-effectiveness of deploying the combination .
-BACKGROUND	www.ClinicalTrials.gov NCT01697852 Please see later in the article for the Editors ' Summary .
-
-###25282033
-OBJECTIVE	The OPTION ( Optimal Anti-Tachycardia Therapy in Implantable Cardioverter-Defibrillator Patients Without Pacing Indications ) trial sought to compare long-term rates of inappropriate shocks , mortality , and morbidity between dual-chamber and single-chamber settings in implantable cardioverter-defibrillators ( ICDs ) patients .
-BACKGROUND	The use of dual-chamber ICDs potentially allows better discrimination of supraventricular arrhythmias and thereby reduces inappropriate shocks .
-BACKGROUND	However , it may lead to detrimental ventricular pacing .
-METHODS	This prospective multicenter , single-blinded trial enrolled 462 patients with de novo primary or secondary prevention indications for ICD placement and with left ventricular ejection fractions 40 % despite optimal tolerated pharmacotherapy .
-METHODS	All patients received atrial leads and dual-chamber defibrillators that were randomized to be programmed either with dual-chamber or single-chamber settings .
-METHODS	In the dual-chamber setting arm , the PARAD + algorithm , which differentiates supraventricular from ventricular arrhythmias , and SafeR mode , to minimize ventricular pacing , were activated .
-METHODS	In the single-chamber setting arm , the acceleration , stability , and long cycle search discrimination criteria were activated , and pacing was set to VVI 40 beats/min .
-METHODS	Ventricular tachycardia detection was required at rates between 170 and 200 beats/min , and ventricular fibrillation detection was activated above 200 beats/min .
-RESULTS	During a follow-up period of 27 months , the time to the first inappropriate shock was significantly longer in the dual-chamber setting arm ( p = 0.012 , log-rank test ) , and 4.3 % of patients in the dual-chamber setting group compared with 10.3 % in the single-chamber setting group experienced inappropriate shocks ( p = 0.015 ) .
-RESULTS	Rates of all-cause death or cardiovascular hospitalization were 20 % for the dual-chamber setting group and 22.4 % for the single-chamber setting group and satisfied the pre-defined margin for equivalence ( p < 0.001 ) .
-CONCLUSIONS	Therapy with dual-chamber settings for ICD discrimination combined with algorithms for minimizing ventricular pacing was associated with reduced risk for inappropriate shock compared with single-chamber settings , without increases in mortality and morbidity .
-CONCLUSIONS	( Optimal Anti-Tachycardia Therapy in Implantable Cardioverter-Defibrillator [ ICD ] Patients Without Pacing Indications [ OPTION ] ; NCT00729703 ) .
-
-###24835417
-BACKGROUND	The purpose of this study is to compare clinical outcomes in the treatment of deep non-contained intrabony defects ( i.e. , with 70 % 1-wall component and a residual 2 - to 3-wall component in the most apical part ) using deproteinized bovine bone mineral ( DBBM ) combined with either enamel matrix protein derivative ( EMD ) or collagen membrane ( CM ) .
-METHODS	Forty patients with multiple intrabony defects were enrolled .
-METHODS	Only one non-contained defect per patient with an intrabony depth 3 mm located in the interproximal area of single - and multirooted teeth was randomly assigned to the treatment with either EMD + DBBM ( test : n = 20 ) or CM + DBBM ( control : n = 20 ) .
-METHODS	At baseline and after 12 months , clinical parameters including probing depth ( PD ) and clinical attachment level ( CAL ) were recorded .
-METHODS	The primary outcome variable was the change in CAL between baseline and 12 months .
-RESULTS	At baseline , the intrabony component of the defects amounted to 6.1 1.9 mm for EMD + DBBM and 6.0 1.9 mm for CM + DBBM sites ( P = 0.81 ) .
-RESULTS	The mean CAL gain at sites treated with EMD + DBBM was not statistically significantly different ( P = 0.82 ) compared with CM + DBBM ( 3.8 1.5 versus 3.7 1.2 mm ) .
-RESULTS	No statistically significant difference ( P = 0.62 ) was observed comparing the frequency of CAL gain 4 mm between EMD + DBBM ( 60 % ) and CM + DBBM ( 50 % ) or comparing the frequency of residual PD 6 mm between EMD + DBBM ( 5 % ) and CM + DBBM ( 15 % ) ( P = 0.21 ) .
-CONCLUSIONS	Within the limitations of the present study , regenerative therapy using either EMD + DBBM or CM + DBBM yielded comparable clinical outcomes in deep non-contained intrabony defects after 12 months .
-
-###24946631
-OBJECTIVE	To compare the differences in the clinical function and lumbar and abdominal myodynamia in patiants of lumbar disc herniation treated with moxibustion at Dazhui ( GV 14 ) and Guanyuan ( CV 4 ) and acupuncture .
-METHODS	Forty cases were randomized into a moxibustion group and an acupuncture group , 20 cases in each group .
-METHODS	In the moxibustion group , the warm moxibustion was applied alternatively at Dazhui ( GV 14 ) and Guanyuan ( CV 4 ) once every other day , 1 h each time , once every day .
-METHODS	In the acupuncture group , acupuncture was applied to the corresponding acupoints based on the affected lumbar vertebras , such as Jiaji ( EX-B 2 ) , Shens-hu ( BL 23 ) , Dachangshu ( BL 25 ) and Huantiao ( GB 30 ) , etc. , once evey day 30 min each time .
-METHODS	The treatment for 3 weeks was taken as one session in each group .
-METHODS	Totally , one session treatment was required .
-METHODS	Surface electromyography ( SEMG ) of bilateral paraspinal muscle and rectus muscle , and JOA score of low back pain were observed in the two groups .
-RESULTS	( 1 ) JOA score : the score of subjective symptoms , score of activity of daily living ( ADL ) and total score were improved obviously as compared with those before treatment in the two groups ( P < 0.01 , P < 0.05 ) .
-RESULTS	The results of subjective symptoms score , score of ADL and total score in the acupuncture group were superior to those in the moxibustion group after treatment ( 6.95 + / -0.94 vs 5.50 + / -0.89,10.90 + / -1.86 vs 8.90 + / - 1.92,22.50 + / - 2.82 vs 19.35 + / - 2.70 , all P < 0.05 ) .
-RESULTS	( 2 ) SEMG comparison : root-mean-square value ( RMS ) was all reduced in SEMG of the anteflexion , rear protraction , orthostatism , bilateral bending and neck and leg rear flexion for strengthening lumbar muscle as compared with those before treatment in the two groups ( P < 0.05 , P < 0.01 ) .
-RESULTS	RMS of the anteflexion and bilateral bending in the acupunture group were reduced much obviously as compared with the moxibustion group .
-RESULTS	In terms of sitting position anteflexion , rear protraction , orthostatism , bilateral bending and neck and leg rear flexion for strengthening lumbar muscle , median frequency ( MF ) after treatment was all improved as compared with that before treatment in the two groups ( P < 0.05 , P < 0.01 ) .
-RESULTS	In terms of anteflexion , the electrode MF after treatment was improved much obviously in the acupuncture group ( P < 0.05 ) .
-CONCLUSIONS	Moxibustion at Dazhui ( GV 14 ) and Guanyuan ( CV 4 ) and conventional acupuncture all improve muscle function , relieve muscle fatigue , increase the ability of anti-muscle fatigue , strengthen lumbar vertebral stability , release subjective symptoms and improve ADL .
-CONCLUSIONS	But , the effects of moxibustion are slightly lower than those of acupuncture .
-
-###24278929
-OBJECTIVE	The aim of this study was to compare clinical outcomes and stability following immediate loading of two types of tapered implants in the partially edentulous posterior maxilla and mandible .
-METHODS	A randomized controlled trial with 1 year of follow-up was performed on participants missing two consecutive teeth in a posterior quadrant with tapered implants with a hybrid textured surface .
-METHODS	Group 1 received Osstem TSIII HA implants , and group 2 received Zimmer TSV implants .
-METHODS	Group 1 implants were 4.5 or 5.0 mm in diameter , and group 2 implants were 4.7 mm in diameter ; all implants were 10 mm long .
-METHODS	Subjects received provisional restorations within 48 hours .
-METHODS	Definitive restorations were provided 3 months ( mandible ) or 6 months ( maxilla ) later .
-METHODS	Outcome measures were survival and success rates , marginal bone level change , implant stability quotient , and peri-implant soft tissue indices .
-RESULTS	Fifty participants completed the trial ( group 1 : 52 implants in 26 patients ; group 2 : 48 implants in 24 patients ) .
-RESULTS	The success rates were similar -- 98.1 % in group 1 and 97.9 % in group 2 -- at 12 months after immediate loading , but marginal bone loss was significantly different according to the implant design .
-RESULTS	Implant stability increased significantly in both arches .
-RESULTS	There were no significant differences in soft tissue indices between implant systems .
-CONCLUSIONS	If high primary stability is acquired , tapered implants with hybrid textured surfaces are predictable for immediate loading in the posterior maxilla and mandible .
-CONCLUSIONS	In spite of the influence of implant design on marginal bone loss , all tapered implants showed successful clinical outcomes and stability in immediate loading .
-
-###24375220
-BACKGROUND	Cardiac surgery and sternotomy are procedures accompanied by substantial postoperative pain which is challenging to treat .
-BACKGROUND	In general , intravenous ( IV ) opioids are used in the immediate postoperative phase , followed by oral opioids .
-BACKGROUND	Oral opioids are easier to use and generally less expensive .
-BACKGROUND	Our goal was thus to determine whether a new opioid preparation provides adequate analgesia after sternotomy .
-BACKGROUND	In particular , we tested the primary hypothesis that total opioid use ( in morphine equivalents ) is not greater with oral opioid compared with patient-controlled IV morphine .
-BACKGROUND	Our secondary hypothesis was that analgesic efficacy is similar with oral and IV opioids .
-METHODS	A total of 51 patients having elective cardiac surgery were enrolled in this study .
-METHODS	After rapid postoperative respiratory weaning , the patients were randomised into one of two groups receiving different types of analgesia : oral Targin ( a combination of oxycodone-hydrochloride and the opioid antagonist naloxone hydrochloride-dihydrate ) or patient-controlled IV morphine .
-METHODS	Pain score ( visual analogue scale ) , sedation ( Ramsey score ) , respiratory rate and side effects were assessed at 3 , 5 , 7 , 9 and 11 h after surgery , and every 6 h throughout the third postoperative evening .
-RESULTS	The total opioid dose in morphine equivalent doses was significantly lower with oral opioid than with IV morphine ( adjusted geometric means [ 95 % confidence interval ] : 34 [ 29 ; 38 ] vs. 69 [ 61 ; 78 ] mg , respectively ) .
-RESULTS	Pain scores were similar in each group .
-CONCLUSIONS	Analgesic quality was comparable with oral and IV opioids , suggesting that postoperative pain even after very painful procedures can be sufficiently managed with oral opioids .
-
-###24603110
-OBJECTIVE	To evaluate the safety and feasibility of percutaneous tract dilation by the one-stage method in preschool children .
-METHODS	Between April 2009 and February 2013 , all preschool ( < 6 years ) children who were candidates for percutaneous nephrolithotomy were enrolled in this prospective study .
-METHODS	Patients were randomly assigned to dilation by serial metallic dilators ( group I , 31 patients ) or dilation by one-stage Amplatz according to Frattini et al. [ J Endourol 2001 ; 15:919 -923 ] ( group II , 31 patients ) .
-METHODS	The primary endpoint of interest was fluoroscopy time .
-METHODS	Secondary endpoints included tract creation and dilation time , success rate and complications .
-METHODS	Stone-free status was defined as residuals 3 mm .
-RESULTS	Age , stone size , operation success and operation time were not significantly different between the studied groups .
-RESULTS	The most common stone composition was calcium oxalate in both groups .
-RESULTS	The mean standard deviation of access and fluoroscopy times in groups I and II were 7.3 1.2 min vs. 5.9 1.5 min ( p > 0.05 ) and 70.0 8.9 s vs. 22.0 5.6 s ( p < 0.001 ) , respectively .
-RESULTS	Postoperative complications included one case of postoperative fever lasting less than 48 h in group I.
-CONCLUSIONS	Percutaneous tract dilation by the one-stage method is safe and effective .
-CONCLUSIONS	Also , it is associated with considerably less radiation exposure in preschool children .
-
-###25330837
-OBJECTIVE	To evaluate the effect of dehydroepiandrosterone ( DHEA ) on infertility patients with diminished ovarian reserve undergoing in vitro fertilization .
-METHODS	This is a prospective study .
-METHODS	Ninety-five patients with diminished ovarian reserve were included in this study .
-METHODS	Of them , 42 patients were randomly allocated to the DHEA group , who received DHEA 75 mg daily for three consecutive menstrual cycles prior to IVF cycles , and 53 patients were allocated to the control group , who entered IVF cycles directly .
-METHODS	All patients were treated with the same ovarian stimulation protocol .
-METHODS	Follicular fluid samples from both groups were collected for bone morphogenetic protein-15 ( BMP-15 ) and growth differentiation factor-9 ( GDF-9 ) .
-METHODS	Fluid from the first aspirated follicle without any visible blood contamination was carefully collected .
-METHODS	In addition , day 3 Blood samples were collected pre - and post-treatment of DHEA for serum anti-Mullerian hormone ( AMH ) , follicle stimulating hormone ( FSH ) and estradiol ( E2 ) in the DHEA group .
-RESULTS	The level of BMP-15 in follicular fluid samples from the DHEA group was significantly higher than that of the control samples ( P = .000 ) .
-RESULTS	Patients after DHEA treatment demonstrated a significantly higher level of AMH and a significantly lower level of FSH , E2 compared to themselves prior to DHEA therapy ( P = .015 ; P = .036 ; P = .002 ; respectively ) .
-RESULTS	Moreover , the accumulated score of embryos was significantly higher in the DHEA group ( P = .033 ) .
-CONCLUSIONS	These observations confirm the beneficial effect of DHEA for infertility patients with diminished ovarian reserve .
-BACKGROUND	ChiCTR-TRC-14005002 .
-
-###25525891
-OBJECTIVE	To compare subjective and objective visual performance of the Air Optix Aqua Multifocal lens to monovision in a group of subjects requiring a medium level of reading-addition power .
-METHODS	Fifty participants with reading additions between 1.25 and 2.00 diopters ( inclusive ) were randomized into a prospective , crossover clinical trial .
-METHODS	They wore monovision and multifocals for 2 weeks in a randomized order .
-METHODS	High - and low-contrast logMAR ( logarithm of the minimum angle of resolution ) acuity and stereopsis were measured at the beginning and end of each period .
-METHODS	During each phase , participants performed specific tasks followed by subjective rating surveys and also completed satisfaction rating surveys on days 3 , 7 , and 12 ; all were transferred in real time using BlackBerry smartphones .
-METHODS	A general rating survey was completed at the dispensing and 2-week visits .
-RESULTS	Forty-nine participants completed the study ( mean age , 52 years ) .
-RESULTS	Distance and near high - and low-contrast acuities were significantly better ( p < 0.05 ) with monovision at all visits .
-RESULTS	High-contrast intermediate acuity was only better ( p < 0.05 ) with multifocals after 2 weeks .
-RESULTS	Stereopsis was equivalent after 2 weeks , but better ( p < 0.05 ) with multifocals at dispensing .
-RESULTS	Subjective ratings were generally equivalent between modalities although there was a trend for multifocals to be rated higher for focus changing and driving , whereas monovision tended to be rated higher for near tasks .
-RESULTS	For both corrections , the satisfaction survey showed no significant change between days 3 , 7 , and 12 , and the general survey showed that comfort was maintained but subjective vision ratings decreased significantly over the 2 weeks .
-RESULTS	Twenty-five participants ( 51 % ) preferred multifocals , 18 ( 37 % ) preferred monovision , and the remaining 6 ( 12 % ) declared both unacceptable .
-CONCLUSIONS	In this cohort , distance and near acuities were better with monovision , whereas the subjective ratings tended to favor the Air Optix Aqua Multifocal , with the exception of near performance .
-CONCLUSIONS	Preference was statistically similar between both corrections , with a trend toward preferring the multifocal .
-
-###25414061
-BACKGROUND	Natural orifice transluminal endoscopic surgery ( NOTES ) is the consequence of further development of minimally invasive surgery to reduce abdominal incisions and surgical trauma .
-BACKGROUND	The potential benefits are expected to be less postoperative pain , faster convalescence , and reduced risk for incisional hernias and wound infections compared to conventional methods .
-BACKGROUND	Recent clinical studies have demonstrated the feasibility and safety of transvaginal NOTES , and transvaginal access is currently the most frequent clinically applied route for NOTES procedures .
-BACKGROUND	However , despite increasing clinical application , no firm clinical evidence is available for objective assessment of the potential benefits and risks of transvaginal NOTES compared to the current surgical standard .
-METHODS	The TRANSVERSAL trial is designed as a randomized controlled trial to compare transvaginal hybrid NOTES and laparoscopic-assisted sigmoid resection .
-METHODS	Female patients referred to elective sigmoid resection due to complicated or reoccurring diverticulitis of the sigmoid colon are considered eligible .
-METHODS	The primary endpoint will be pain intensity during mobilization 24 hours postoperatively as measured by the blinded patient and blinded assessor on a visual analogue scale ( VAS ) .
-METHODS	Secondary outcomes include daily pain intensity and analgesic use , patient mobility , intraoperative complications , morbidity , length of stay , quality of life , and sexual function .
-METHODS	Follow-up visits are scheduled 3 , 12 , and 36 months after surgery .
-METHODS	A total sample size of 58 patients was determined for the analysis of the primary endpoint .
-METHODS	The confirmatory analysis will be performed based on the intention-to-treat ( ITT ) principle .
-CONCLUSIONS	The TRANSVERSAL trial is the first study to compare transvaginal hybrid NOTES and conventionally assisted laparoscopic surgery for colonic resection in a randomized controlled setting .
-CONCLUSIONS	The results of the TRANSVERSAL trial will allow objective assessment of the potential benefits and risks of NOTES compared to the current surgical standard for sigmoid resection .
-BACKGROUND	The trial protocol was registered in the German Clinical Trials Register ( DRKS00005995 ) on March 27 , 2014 .
-
-###25539823
-BACKGROUND	Aetiology of childhood leukaemia and childhood neoplasm is poorly understood .
-BACKGROUND	Information on the prevalence of risk factors in the childhood population is limited .
-BACKGROUND	SETIL is a population based case-control study on childhood leukaemia , conducted with two companion studies on non-Hodgkin Lymphoma ( NHL ) and neuroblastoma .
-BACKGROUND	The study relies on questionnaire interviews and 50 Hz magnetic field ( ELF-MF ) indoor measurements .
-BACKGROUND	This paper discusses the SETIL study design and includes descriptive information .
-METHODS	The study was carried out in 14 Italian regions ( 78.3 % of Italian population aged 0-10 ) .
-METHODS	It included leukaemia , NHL and neuroblastoma cases incident in 0-10 year olds in 1998-2001 , registered by the Italian Association of Paediatric Haematology and Oncology ( AIEOP ) ( accrual over 95 % of estimated incidence ) .
-METHODS	Two controls for each leukaemia case were randomly sampled from the Local Health Authorities rolls , matched by gender , birthdate and residence .
-METHODS	The same controls were used in NHL and neuroblastoma studies .
-METHODS	Parents were interviewed at home on : physical agents ( ELF-MF and ionizing radiation ) , chemicals ( smoking , solvents , traffic , insecticides ) , occupation , medical and personal history of children and parents , infectious diseases , immunizations and associated factors .
-METHODS	Occupational exposure was collected using job specific modules .
-METHODS	ELF-MF was measured in the main rooms ( spot measurement ) and close to child 's bed ( 48 hours measurement ) .
-RESULTS	The study included : 683 leukaemia cases ( 87 % ALL , 13 % AnLL ) , 97 NHL , 155 neuroblastomas , and 1044 controls .
-CONCLUSIONS	SETIL represents a data source on exposure of Italian children to a broad array of potential carcinogenic factors .
-
-###24770617
-BACKGROUND	Highly HLA-sensitized ( HS ) patients have difficulty accessing compatible donors , especially deceased donor ( DD ) transplants .
-BACKGROUND	Desensitization protocols ( DES ) have evolved , but rigorous evaluation is lacking .
-BACKGROUND	Here , we examined the efficacy of rituximab as a DES agent in a placebo-controlled trial .
-METHODS	Candidates were randomized to IVIG + placebo versus IVIG + rituximab .
-METHODS	End points included rates of transplantation , antibody-mediated rejection ( ABMR ) , and renal function .
-METHODS	Protocol biopsies were performed at 1 year and analysis of patient and graft survival and donor-specific HLA antibodies ( DSA ) were performed .
-RESULTS	Initially , 15 HS DDs were randomized with 13 receiving transplants .
-RESULTS	However , we discontinued study entry after five serious adverse events were observed .
-RESULTS	The study was un-blinded and attribution of patients was noted ( IVIG + placebo N = 7 , IVIG + rituximab N = 6 ) .
-RESULTS	No significant differences were seen in DSA levels at transplant .
-RESULTS	All ABMR episodes occurred in the IVIG + placebo arm and required intense therapy ( P = 0.06 ) .
-RESULTS	The two graft losses were in the placebo group .
-RESULTS	DSA rebound associated with severe ABMR was seen in three patients in the IVIG + placebo group .
-RESULTS	No rebound was seen in the IVIG + rituximab group .
-RESULTS	Renal function at 6 and 12 months showed a significant benefit for IVIG + rituximab ( P = 0.04 ) .
-CONCLUSIONS	Based on limited assessment with acknowledged limitations , both protocols appear effective in achieving levels of DSA allowable for transplantation .
-CONCLUSIONS	However , IVIG + rituximab appeared more effective in preventing DSA rebound and , more importantly , preventing ABMR and development of transplant glomerulopathy .
-
-###24953368
-OBJECTIVE	To evaluate the clinical efficacy and safety of tissue-selecting therapy ( TST ) in treatment of mixed hemorrhoids .
-METHODS	A single-blind randomized study was carried out .
-METHODS	A total of 120 patients with mixed hemorrhoids from January to December 2012 were prospectively enrolled in the study and equally divided into two groups , TST group and procedure for prolapse and hemorrhoids ( PPH ) group .
-METHODS	Surgical data , efficacy and postoperative complications were compared between the two groups .
-RESULTS	As compared to PPH group , patients in TST group had shorter operation time [ ( 15.95.18 ) min vs. ( 22.67.1 ) min , P < 0.05 ] , lower scores of rectal urgency ( 0.50.2 vs. 1.51.4 , P < 0.05 ) , and shorter hospital stay [ ( 11.23.7 ) d vs. ( 14.83.7 ) d , P < 0.05 ] .
-RESULTS	No anastomotic stricture case was found in TST group , while 11 cases ( 18.3 % ) developed anastomotic stricture in PPH group .
-RESULTS	There were no significant differences in effective rate and pain score of first defecation between the two groups .
-CONCLUSIONS	TST is reliable and safe for mixed hemorrhoids with the advantage of simple , rapid recovery and less complications .
-
-###25234524
-OBJECTIVE	The surgical removal of mandibular third molars is frequently accompanied by significant postsurgicalsequelae , and different protocols have been described to decrease such adverse events .
-OBJECTIVE	The aim of this study was to investigate the performance of piezosurgery compared with traditional rotating instrumentsduring mandibular third molar removal .
-METHODS	A single-center , randomized , split-mouth study was performed using a consecutive series of unrelated healthy patients attending the Oral Surgery Unit of the University of Turin for surgical removal of bilateral mandibular third molar teeth .
-METHODS	Each patient was treated , at the same appointment , using bur removal on 1 side of the mandible and a piezoelectric device on the contralateral side .
-METHODS	The primaryoutcomes reported were postoperative pain , objective orofacial swelling , and surgical duration ; secondary outcomes were gender , age , and possible adverse events .
-METHODS	Analysis of variance or paired t test was used as appropriate to test any significant differences at baseline according to each treatment subgroup , and categorical variables were analyzed by ( 2 ) test .
-RESULTS	The study sample consisted of 100 otherwise healthy patients .
-RESULTS	The mean pain evaluation reportedby patients who underwent surgery with piezosurgery was significantly lower than that reported after bur ( conventional ) removal , reaching statistical difference after 4 days ( P = .043 ) .
-RESULTS	The clinical value oforofacial swelling at day 7 , normalized to baseline , was lower in the piezosurgery group ( P < .005 ) .
-RESULTS	Theaverage surgical duration was significantly shorter in the bur group than in the piezosurgery group ( P < .05 ) .
-RESULTS	Three patients having bur removal developed short-term complications ( 2 dry sockets and 1temporaryparaesthesia ) , which totally resolved by 4 weeks .
-CONCLUSIONS	To date , this prospective investigation is the largest reported split-mouth study on piezosurgeryfor lower third molar tooth removal .
-CONCLUSIONS	This study also compared surgeons with different degreesof experience .
-CONCLUSIONS	It is evident that using a piezoelectric device can enhance the patient experience and decrease postoperative pain and swelling .
-
-###25266438
-OBJECTIVE	To evaluate efficacy and safety of eszopiclone compared with placebo in children and adolescents with insomnia associated with attention-deficit/hyperactivity disorder ( ADHD ) .
-METHODS	A 12-week , randomized , double-blind , placebo-controlled trial evaluated efficacy and safety of high - or low-dose eszopiclone ( 1 or 2 mg in children aged 6-11 years , 2 or 3 mg in children ages 12-17 years ) , given every evening , in 486 patients with ADHD-related insomnia .
-METHODS	The primary efficacy variable was change in latency to persistent sleep from baseline to week 12 , based on polysomnography .
-METHODS	Key secondary measures were polysomnography-measured wake time after sleep onset , Clinical Global Impression Parent/Caregiver and Child scales , and the Conners ' ADHD rating scales .
-METHODS	The safety of eszopiclone was further studied over 1 year of open-label treatment in 55 patients who completed the double-blind study , and 249 patients with no previous eszopiclone exposure .
-RESULTS	Neither low-dose nor high-dose eszopiclone significantly reduced latency to persistent sleep compared with placebo after 12 weeks of treatment .
-RESULTS	Secondary outcomes were considered nonsignificant based on the hierarchical statistical analysis plan .
-RESULTS	The most frequent treatment-emergent adverse events over 12 weeks with eszopiclone were headache , dysgeusia , and dizziness .
-RESULTS	The study results demonstrated that eszopiclone was well tolerated over 1 year of treatment , with 11.2 % of patients discontinuing open-label treatment because of an adverse event .
-CONCLUSIONS	Eszopiclone ( up to 3 mg ) failed to reduce latency to persistent sleep on polysomnography after 12 weeks in children aged 6 to 17 years with ADHD-related insomnia .
-CONCLUSIONS	Eszopiclone was well tolerated in the 1-year study .
-
-###24252663
-BACKGROUND	Cognitive-behavioral therapy ( CBT ) has demonstrated efficacy and effectiveness for treating mood and anxiety disorders .
-BACKGROUND	Dissemination of CBT via videoconference may help improve access to treatment .
-OBJECTIVE	The present study aimed to compare the effectiveness of CBT administered via videoconference to in-person therapy for a mixed diagnostic cohort .
-METHODS	A total of 26 primarily Caucasian clients ( mean age 30 years , SD 11 ) who had a primary Diagnostic and Statistical Manual of Mental Disorders , 4th edition text revision ( DSM-IV-TR ) diagnosis of a mood or anxiety disorder were randomly assigned to receive 12 sessions of CBT either in-person or via videoconference .
-METHODS	Treatment involved individualized CBT formulations specific to the presenting diagnosis ; all sessions were provided by the same therapist .
-METHODS	Participants were recruited through a university clinic .
-METHODS	Symptoms of depression , anxiety , stress , and quality of life were assessed using questionnaires before , after , and 6 weeks following treatment .
-METHODS	Secondary outcomes at posttreatment included working alliance and client satisfaction .
-RESULTS	Retention was similar across treatment conditions ; there was one more client in the videoconferencing condition at posttreatment and at follow-up .
-RESULTS	Statistical analysis using multilevel mixed effects linear regression indicated a significant reduction in client symptoms across time for symptoms of depression ( P < .001 , d = 1.41 ) , anxiety ( P < .001 , d = 1.14 ) , stress ( P < .001 , d = 1.81 ) , and quality of life ( P < .001 , d = 1.17 ) .
-RESULTS	There were no significant differences between treatment conditions regarding symptoms of depression ( P = .165 , d = 0.37 ) , anxiety ( P = .41 , d = 0.22 ) , stress ( P = .15 , d = 0.38 ) , or quality of life ( P = .62 , d = 0.13 ) .
-RESULTS	There were no significant differences in client rating of the working alliance ( P = .53 , one-tailed , d = -0.26 ) , therapist ratings of the working alliance ( P = .60 , one-tailed , d = 0.23 ) , or client ratings of satisfaction ( P = .77 , one-tailed , d = -0.12 ) .
-RESULTS	Fisher 's Exact P was not significant regarding differences in reliable change from pre - to posttreatment or from pretreatment to follow-up for symptoms of depression ( P = .41 , P = .26 ) , anxiety ( P = .60 , P = .99 ) , or quality of life ( P = .65 , P = .99 ) but was significant for symptoms of stress in favor of the videoconferencing condition ( P = .03 , P = .035 ) .
-RESULTS	Difference between conditions regarding clinically significant change was also not observed from pre - to posttreatment or from pretreatment to follow-up for symptoms of depression ( P = .67 , P = .30 ) , anxiety ( P = .99 , P = .99 ) , stress ( P = .19 , P = .13 ) , or quality of life ( P = .99 , P = .62 ) .
-CONCLUSIONS	The findings of this controlled trial indicate that CBT was effective in significantly reducing symptoms of depression , anxiety , and stress and increasing quality of life in both in-person and videoconferencing conditions , with no significant differences being observed between the two .
-BACKGROUND	Australian New Zealand Clinical Trials Registry ID : ACTRN12609000819224 ; http://www.anzctr.org.au/ACTRN12609000819224.aspx ( Archived by WebCite at http://www.webcitation.org/6Kz5iBMiV ) .
-
-###25059523
-BACKGROUND	The aim of this study was to investigate the effects of mass drug administration on Schistosoma mansoni prevalence and associated liver morbidity in treated school-aged children and untreated preschool children .
-METHODS	In April 2008 , parasitological ( using the Kato-Katz method ) and morbidity ( determined by portal vein score ) data were collected from 263 schoolchildren aged 6 and 7 years .
-METHODS	The children had never received praziquantel .
-METHODS	In March 2010 , following two annual rounds of mass drug administration , 207 children aged 8 and 9 years old were examined to determine the effect of treatment .
-METHODS	In addition , 158 untreated 6-year-olds were assessed to compare with the untreated children from 2008 .
-RESULTS	Treatment significantly decreased the prevalence of S. mansoni and associated morbidity in the treated groups .
-RESULTS	The untreated preschool children also showed a significant decrease in the prevalence of S. mansoni , from 21.1 % ( 2008 ) to 6.3 % ( 2010 ) ( p < 0.001 ) .
-RESULTS	The percentage of untreated schoolchildren with a normal portal vein score increased significantly from 57.8 % ( 2008 ) to 70.3 % ( 2010 ) ( p = 0.029 ) .
-CONCLUSIONS	The significantly lower rates of S. mansoni and the decreased liver morbidity in untreated preschool children in 2010 suggest decreased environmental transmission rates and improved liver morbidity in untreated children following several rounds of mass drug administration .
-
-###25201533
-OBJECTIVE	To evaluate the efficacy of a large capsulorhexis and intraocular lens ( IOL ) in obtaining a larger anterior capsule opening after cataract surgery in patients with diabetes mellitus ( DM ) .
-METHODS	Department of Ophthalmology , University of Fukui , Fukui , Japan .
-METHODS	Prospective clinical trial .
-METHODS	Patients with DM had bilateral cataract surgery with a 2.8 or 3.0 mm scleral incision , a capsulorhexis with a diameter of approximately 5.0 or 6.0 mm , and implantation of a 6.0 mm optic ( Eternity X-60 ) or 7.0 mm optic ( Eternity X-70 ) IOL .
-METHODS	The anterior capsule opening area , aqueous flare intensity , surgically induced astigmatism ( SIA ) , corneal endothelial cell density ( ECD ) , and central corneal thickness ( CCT ) were measured 1 day , 1 week , and 1 , 3 , and 6 months after surgery .
-RESULTS	Thirty-one patients ( 62 eyes ) with DM were enrolled .
-RESULTS	At all postoperative timepoints , the anterior capsule opening was significantly larger in eyes with the 7.0 mm optic IOL than in eyes with the 6.0 mm optic IOL ( P < .05 , Mann-Whitney U test ) .
-RESULTS	There were no significant differences in postoperative aqueous flare intensity , SIA , ECD , or CCT based on the size of the capsulorhexis and IOL .
-CONCLUSIONS	A larger capsulorhexis and implantation of a 7.0 mm IOL resulted in a larger anterior capsule opening after cataract surgery in patients with DM .
-BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .
-
-###25056567
-OBJECTIVE	We sought to determine the dose-response effects of extended-release ( ER ) dexmethylphenidate ( d-MPH ) and ER mixed amphetamine salts ( MAS ) on objective measures of sleep .
-METHODS	This was an 8-week , double-blind , placebo-controlled , randomized , two period , crossover study of youth with attention-deficit hyperactivity disorder ( ADHD ) as confirmed by the Kiddie Schedule for Affective Disorders for School-Age Children-Present and Lifetime version ( K-SADS-PL ) .
-METHODS	Children aged 10-17 years were recruited from clinical practice , colleague referrals , and flyers .
-METHODS	Participants were randomized to initially receive either d-MPH or MAS .
-METHODS	During each 4-week drug period , children received three dose levels ( 10 , 20 , and 25/30mg ) in ascending order , with placebo substituted for active medication in a randomized fashion during 1week of the study .
-METHODS	After 4weeks , participants were switched to the alternative medication for another 4weeks of treatment .
-METHODS	The main outcome measure was sleep duration as measured by actigraphy .
-METHODS	Children , parents , and researchers were blinded to drug , dose , and placebo status .
-RESULTS	Sixty-five participants met the inclusion criteria and were enrolled in the study .
-RESULTS	Of these , 37 participants with sufficient sleep data for analysis were included .
-RESULTS	Sleep schedule measures showed a significant effect for dose on sleep start time ( F ( 1,36 ) = 6.284 ; p < 0.05 ) , with a significantly later sleep start time when children were receiving 20 - or 30-mg doses , compared with placebo ( p < 0.05 ) .
-RESULTS	A significant dose effect was found on actual sleep duration ( F ( 1,36 ) = 8.112 ; p < 0.05 ) , with significantly shorter actual sleep duration for subjects receiving 30mg compared with those receiving placebo ( p < 0.05 ) .
-RESULTS	There were no significant differences on sleep duration or sleep schedule between the two stimulant medications .
-RESULTS	The trial is complete and closed to follow-up .
-CONCLUSIONS	Higher stimulant doses were associated with reduced sleep duration and later sleep start times , regardless of medication class .
-BACKGROUND	ClinicalTrials.gov : NCT00393042 .
-
-###25366886
-BACKGROUND	Survival rates after sudden cardiac arrest could be increased if bystanders could be encouraged to perform CPR until emergency services arrive .
-BACKGROUND	This should be initiated by the dispatcher at the emergency control facility who receives the call .
-BACKGROUND	For the first time the ERC guidelines of 2010 included instructions to be given to untrained rescuers by the dispatcher .
-BACKGROUND	Rapid recognition of cardiac arrest and initiation of emergency measures is assured by means of specific training for the dispatchers .
-OBJECTIVE	The aim of this investigation was to determine whether the time between an emergency call and beginning of cardiopulmonary resuscitation ( CPR ) could be shortened using a simple protocol and whether a relationship exists between the intensity of phone contact between dispatcher and caller and if this improves the results .
-METHODS	In known cases of unconsciousness , group 1 ( 45 persons ) received short CPR instructions via the phone , where the dispatcher was on the phone for continuous advice until emergency services arrived .
-METHODS	Group 2 ( 45 persons ) received identical phone instructions like group 1 , but the phone call was terminated by the dispatcher after the information was provided .
-METHODS	Group 3 ( 29 persons ) only received instructions to start CPR .
-RESULTS	On average , all test persons in group 1 started reanimation after 68.033.5 s , in group 2 after 68.325.2 s , and in group 3 after 64.934.4 s.
-RESULTS	The compression frequency on average was 98.3 / min in group 1 , 84.8 / min in group 2 , and 85.2 / min in group 3 ; therefore , all groups reached an average frequency of > 80/min .
-RESULTS	The correct compression depth was achieved by 47.8 % of test persons in group 1 , by 44.2 % in group 2 , and by 30.2 % in group 3 .
-RESULTS	All volunteers felt well supported .
-RESULTS	Of the 90 people , 70 did not feel that they were missing instructions .
-CONCLUSIONS	There were no significant differences between the groups regarding the target variables .
-CONCLUSIONS	The results show that already extremely short instructions or advice by the dispatcher to start CPR is sufficient to encourage bystanders to give assistance in an emergency .
-CONCLUSIONS	Continuous support over the phone does not appear to be necessary .
-
-###24727030
-OBJECTIVE	To evaluate the effects of peritoneal cold nebulization of ropivacaine on pain control after gynecologic laparoscopy .
-METHODS	Evidence obtained from a properly designed , randomized , double-blind , placebo-controlled trial ( Canadian Task Force classification I ) .
-METHODS	Tertiary care center .
-METHODS	One hundred thirty-five women with American Society of Anesthesiologists disease classified as ASA I-III who were scheduled to undergo operative laparoscopy .
-METHODS	Patients were randomized to receive either nebulization of 30 mg ropivacaine before surgery ( preoperative group ) , nebulization of 30 mg ropivacaine after surgery ( postoperative group ) , instillation of 100 mg ropivacaine before surgery ( instillation group ) , or instillation of saline solution ( control group ) .
-METHODS	Nebulization was performed using the Aeroneb Pro device .
-RESULTS	Pain scores , morphine consumption , and ambulation time were collected in the post-anesthesia care unit and at 4 , 6 , and 24 hours postoperatively .
-RESULTS	One hundred eighteen patients completed the study .
-RESULTS	Patients in the preoperative group reported lower pain Numeric Ranking Scale values compared with those in the control group ( net difference 2 points ; 95 % confidence interval [ CI ] , 0.3-3 .1 at 4 hours , 1-3 at 6 hours , and 0.7-3 at 24 hours ; p = .01 ) Patients in the preoperative group consumed significantly less morphine than did those in the control group ( net difference 7 mg ; 95 % CI , 0.7-13 ; p = .02 ) .
-RESULTS	More patients who received nebulization walked without assistance within 12 hours after awakening than did those in the instillation and control groups ( net difference 15 % ; 95 % CI , 6 % -24 % ; p = .001 ) .
-CONCLUSIONS	Cold nebulization of ropivacaine before surgery reduced postoperative pain and morphine consumption and was associated with earlier walking without assistance .
-
-###24960387
-OBJECTIVE	The purpose of this study was to verify the influence of prebrushing mouthwashes on dental plaque removal in children .
-METHODS	This study had a double-blind , randomized , controlled , crossover , 25-day experimental design , including 38 12 - to 14-year-olds .
-METHODS	Four solutions were used as prebrushing mouthwashes ( Colgate Plax Magic , Listerine Cool Blue Agent , water and dye , and water ) by each participant with seven days ' washout .
-METHODS	The plaque index was evaluated before and after tooth-brushing during the experimental period .
-RESULTS	Intergroup comparisons showed no significant differences in plaque reduction among evaluated solutions ( Friedman test , P > .78 ) .
-RESULTS	Significantly more plaque was present before vs. after tooth-brushing ( Wilcoxon rank test , P < .001 ) , independent of the surface ( buccal or lingual/palatal ) .
-CONCLUSIONS	Use of prebrushing mouthwashes by children does not influence plaque removal by tooth-brushing .
-
-###25539757
-BACKGROUND	Treatments of eating disorders result too often in partial psychological and physical remission , chronicization , dropout , relapse and death , with no fully known explanations for this failure .
-BACKGROUND	In order to clarify this problem , we conducted three studies to identify the biochemical background of cognitive-behavioural psychotherapy ( CBT ) , individual psychology brief psychotherapy ( IBPP ) , and psychotherapy-pharmacotherapy with CBT + olanzapine in anorexics ( AN ) and bulimics ( BN ) by measuring the levels of plasma homovanillic acid ( HVA ) for dopamine secretion , plasma 3-methoxy-4-hydroxy-phenylglycol ( MHPG ) for noradrenalin secretion , and platelet [ 3H ] - Paroxetin-binding Bmax and Kd for serotonin transporter function .
-BACKGROUND	The data were then compared with psychopathological and physical alterations .
-METHODS	Study 1 investigated the effects of 4 months of CBT on plasma HVA , MHPG and [ 3H ] - Par-binding in 14 AN-restricted , 14 AN-bingeing/purging , and 22 BN inpatients .
-METHODS	Study 2 investigated the effects of 4 months of IBPP on plasma HVA in 15 AN and 17 BN outpatients .
-METHODS	Study 3 investigated the effect of 3 months of CBT + olanzapine ( 5 mg/day ) in 30 AN outpatients .
-METHODS	The data were analyzed using one-way ANOVA for repeated measures for the changes between basal and post-treatment biological and psychological parameters , two-way ANOVA for repeated measures for the differences in the psychobiological data in the 3 groups , Spearman 's test for the correlations between basal and final changes in the psychological and biological scores .
-RESULTS	Study 1 revealed significant amelioration of the psychopathology in the AN and BN patients , no effects on HVA , MHPG or Paroxetin binding Kd , and a significant increase in Par-binding Bmax only in the BN patients .
-RESULTS	Study 2 revealed a significant effect of IBPP on psychopathology in the AN and BN patients , and a significant increase in HVA only in the BN patients .
-RESULTS	Study 3 revealed a significant positive effect of CBT + olanzapine therapy on the psychopathology and increased HVA values .
-RESULTS	No correlations were observed in the 3 groups between biological and psychological effects of the three treatments .
-CONCLUSIONS	Our data advance suggestions on the mechanism of action of the three therapies ; however , the lack of correlations between biochemical and psychological effects casts doubt on their significance .
-CONCLUSIONS	Clinical Trials.gov .
-CONCLUSIONS	Identifier NCT01990755 .
-
-###24435063
-OBJECTIVE	This study explored the interest in genomic testing for modest changes in colorectal cancer risk and preferences for receiving genomic risk communications among individuals with intermediate disease risk due to a family history of colorectal cancer .
-METHODS	Surveys were conducted on 272 men and women at intermediate risk for colorectal cancer enrolled in a randomized trial comparing a remote personalized risk communication intervention ( TeleCARE ) aimed at promoting colonoscopy to a generic print control condition .
-METHODS	Guided by Leventhal 's Common Sense Model of Self-Regulation , we examined demographic and psychosocial factors possibly associated with interest in SNP testing .
-METHODS	Descriptive statistics and logistic regression models were used to identify factors associated with interest in SNP testing and preferences for receiving genomic risk communications .
-RESULTS	Three-fourths of participants expressed interest in SNP testing for colorectal cancer risk .
-RESULTS	Testing interest did not markedly change across behavior modifier scenarios .
-RESULTS	Participants preferred to receive genomic risk communications from a variety of sources : printed materials ( 69.5 % ) , oncologists ( 54.8 % ) , primary-care physicians ( 58.4 % ) , and the web ( 58.1 % ) .
-RESULTS	Overall , persons who were unmarried ( p = 0.029 ) , younger ( p = 0.003 ) and with greater cancer-related fear ( p = 0.019 ) were more likely to express interest in predictive genomic testing for colorectal cancer risk .
-RESULTS	In a stratified analysis , cancer-related fear was associated with the interest in predictive genomic testing in the intervention group ( p = 0.017 ) , but not the control group .
-CONCLUSIONS	Individuals with intermediate familial risk for colorectal cancer are highly interested in genomic testing for modest increases in disease risk , specifically unmarried persons , younger age groups and those with greater cancer fear .
-
-###25587090
-BACKGROUND	Despite effective treatments to reduce cardiovascular disease risk , their translation into practice is limited .
-RESULTS	Using a parallel arm cluster-randomized controlled trial in 60 Australian primary healthcare centers , we tested whether a multifaceted quality improvement intervention comprising computerized decision support , audit/feedback tools , and staff training improved ( 1 ) guideline-indicated risk factor measurements and ( 2 ) guideline-indicated medications for those at high cardiovascular disease risk .
-RESULTS	Centers had to use a compatible software system , and eligible patients were regular attendees ( Aboriginal and Torres Strait Islander people aged 35 years and others aged 45 years ) .
-RESULTS	Patient-level analyses were conducted using generalized estimating equations to account for clustering .
-RESULTS	Median follow-up for 38,725 patients ( mean age , 61.0 years ; 42 % men ) was 17.5 months .
-RESULTS	Mean monthly staff support was < 1 hour/site .
-RESULTS	For the coprimary outcomes , the intervention was associated with improved overall risk factor measurements ( 62.8 % versus 53.4 % risk ratio ; 1.25 ; 95 % confidence interval , 1.04-1 .50 ; P = 0.02 ) , but there was no significant differences in recommended prescriptions for the high-risk cohort ( n = 10,308 ; 56.8 % versus 51.2 % ; P = 0.12 ) .
-RESULTS	There were significant treatment escalations ( new prescriptions or increased numbers of medicines ) for antiplatelet ( 17.9 % versus 2.7 % ; P < 0.001 ) , lipid-lowering ( 19.2 % versus 4.8 % ; P < 0.001 ) , and blood pressure-lowering medications ( 23.3 % versus 12.1 % ; P = 0.02 ) .
-CONCLUSIONS	In Australian primary healthcare settings , a computer-guided quality improvement intervention , requiring minimal support , improved cardiovascular disease risk measurement but did not increase prescription rates in the high-risk group .
-CONCLUSIONS	Computerized quality improvement tools offer an important , albeit partial , solution to improving primary healthcare system capacity for cardiovascular disease risk management .
-BACKGROUND	https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=336630 .
-BACKGROUND	Australian New Zealand Clinical Trials Registry No. 12611000478910 .
-
-###25527071
-BACKGROUND	The Centre for the AIDS Programme of Research in South Africa ( CAPRISA ) 004 trial demonstrated a 39 % reduction in HIV infection , with a 54 % HIV reduction in women who used tenofovir gel consistently .
-BACKGROUND	A confirmatory trial is expected to report results in early 2015 .
-BACKGROUND	In the interim , we have a unique window of opportunity to prepare for and devise effective strategies for the future policy and programmatic scale-up of tenofovir gel provision .
-BACKGROUND	One approach is to integrate tenofovir gel provision into family planning ( FP ) services .
-BACKGROUND	The CAPRISA 008 implementation trial provides an opportunity to provide post-trial access to tenofovir gel while generating empiric evidence to assess whether integrating tenofovir gel provision into routine FP services can achieve similar levels of adherence as the CAPRISA 004 trial .
-METHODS	This is a two-arm , open-label , randomized controlled non-inferiority trial .
-METHODS	A maximum of 700 sexually active , HIV-uninfected women aged 18 years and older who previously participated in an antiretroviral prevention study will be enrolled from an urban and rural site in KwaZulu-Natal , South Africa .
-METHODS	The anticipated study duration is 30 months , with active accrual requiring approximately 12 months ( following which an open cohort will be maintained ) and follow-up continuing for approximately 18 months .
-METHODS	At each of the two sites , eligible participants will be randomly assigned to receive tenofovir gel through either FP services ( intervention arm ) or through the CAPRISA research clinics ( control arm ) .
-METHODS	As part of the study intervention , a quality improvement approach will be used to assist the FP services to expand their current services to include tenofovir gel provision .
-CONCLUSIONS	This protocol aims to address an important implementation question on whether FP services are able to effectively incorporate tenofovir gel provision for this at-risk group of women in South Africa .
-CONCLUSIONS	Provision of tenofovir gel to the women from the CAPRISA 004 trial meets the ethical obligation for post-trial access , and helps identify a potential avenue for future scale-up of microbicides within the public health system of South Africa .
-BACKGROUND	This trial was registered with the South Africa Department of Health ( reference : DOH-27-0812-4129 ) and ClinicalTrials.gov ( reference : NCT01691768 ) on 05 July 2012 .
-
-###24380989
-BACKGROUND	Food residue in the remnant stomach after subtotal gastrectomy ( STG ) interferes with endoscopic observation .
-BACKGROUND	We investigated whether intravenous erythromycin improves gastric mucosa visualization in patients with STG .
-METHODS	This study was conducted from April 2012 to October 2012 as a double-blinded , placebo-controlled , randomized trial .
-METHODS	Patients who received STG with complete resection ( stage T1-2N0M0 ) were included .
-METHODS	Exclusion criteria were diabetes mellitus , neurologic disease , myopathy , recent viral enteritis history , concomitant therapy influencing gastrointestinal motility and severe comorbidity .
-METHODS	Patients were instructed to consume a soft diet for dinner between 1800 and 2000 h , and endoscopies were performed between 0900 and 1200 h. Patients were assigned randomly to receive either erythromycin ( 125 mg in normal saline 50 cc ) or placebo saline .
-METHODS	The endoscopy was performed 15 min after infusion .
-METHODS	Grade of residual food was rated as follows : G0 , no residual food ; G1 , a small amount of residual food ; G2 , a moderate amount of residual food ; G3 , a moderate amount of residual food that hinders observation of the entire surface , even with body rolling ; G4 , a great amount of residual food such that endoscopic observation is impossible .
-RESULTS	When good visibility was defined as G0 + G1 , visibility was significantly better in the erythromycin group ( 61 + 19 % ) than in the placebo group ( 38 + 12 % , p < 0.001 ) .
-RESULTS	However , this effect was not seen in patients within 6 months after gastrectomy .
-RESULTS	The risk factor for food stasis in the placebo group ( n = 58 ) was food stasis at last endoscopy .
-RESULTS	The only factor predicting erythromycin response in the erythromycin group ( n = 56 ) was elapsed time since surgery .
-RESULTS	Adverse effects included nausea [ 11 ( 19.7 % ) ] and vomiting [ 1 ( 1.8 % ) ] in the erythromycin group and vomiting [ 3 ( 5.2 % ) ] in the placebo group .
-RESULTS	However , they were transient and tolerable .
-CONCLUSIONS	Premedication with erythromycin improves mucosal visualization during endoscopy in patients with STG .
-BACKGROUND	NCT01659619 ) .
-
-###24285617
-OBJECTIVE	To test the hypothesis that daily acute intermittent hypoxia ( dAIH ) and dAIH combined with overground walking improve walking speed and endurance in persons with chronic incomplete spinal cord injury ( iSCI ) .
-METHODS	Nineteen subjects completed the randomized , double-blind , placebo-controlled , crossover study .
-METHODS	Participants received 15 , 90-second hypoxic exposures ( dAIH , fraction of inspired oxygen [ Fio2 ] = 0.09 ) or daily normoxia ( dSHAM , Fio2 = 0.21 ) at 60-second normoxic intervals on 5 consecutive days ; dAIH was given alone or combined with 30 minutes of overground walking 1 hour later .
-METHODS	Walking speed and endurance were quantified using 10-Meter and 6-Minute Walk Tests .
-METHODS	The trial is registered at ClinicalTrials.gov ( NCT01272349 ) .
-RESULTS	dAIH improved walking speed and endurance .
-RESULTS	Ten-Meter Walk time improved with dAIH vs dSHAM after 1 day ( mean difference [ MD ] 3.8 seconds , 95 % confidence interval [ CI ] 1.1-6 .5 seconds , p = 0.006 ) and 2 weeks ( MD 3.8 seconds , 95 % CI 0.9-6 .7 seconds , p = 0.010 ) .
-RESULTS	Six-Minute Walk distance increased with combined dAIH + walking vs dSHAM + walking after 5 days ( MD 94.4 m , 95 % CI 17.5-171 .3 m , p = 0.017 ) and 1-week follow-up ( MD 97.0 m , 95 % CI 20.1-173 .9 m , p = 0.014 ) .
-RESULTS	dAIH + walking increased walking distance more than dAIH after 1 day ( MD 67.7 m , 95 % CI 1.3-134 .1 m , p = 0.046 ) , 5 days ( MD 107.0 m , 95 % CI 40.6-173 .4 m , p = 0.002 ) , and 1-week follow-up ( MD 136.0 m , 95 % CI 65.3-206 .6 m , p < 0.001 ) .
-CONCLUSIONS	dAIH walking improved walking speed and distance in persons with chronic iSCI .
-CONCLUSIONS	The impact of dAIH is enhanced by combination with walking , demonstrating that combinatorial therapies may promote greater functional benefits in persons with iSCI .
-METHODS	This study provides Class I evidence that transient hypoxia ( through measured breathing treatments ) , along with overground walking training , improves walking speed and endurance after iSCI .
-
-###24661817
-BACKGROUND	Pulmonary coagulopathy is a hallmark of lung injury following inhalation trauma .
-BACKGROUND	Locally applied heparin attenuates lung injury in animal models of smoke inhalation .
-BACKGROUND	Whether local treatment with heparin benefits patients with inhalation trauma is uncertain .
-BACKGROUND	The present trial aims at comparing a strategy using frequent nebulizations of heparin with standard care in intubated and ventilated burn patients with bronchoscopically confirmed inhalation trauma .
-METHODS	The Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized HEParin versus Placebo in BURN Patients with Inhalation Trauma ( HEPBURN ) is an international multi-center , double-blind , placebo-controlled , two-arm study .
-METHODS	One hundred and sixteen intubated and ventilated burn patients with confirmed inhalation trauma are randomized to nebulizations of heparin ( the nebulized heparin strategy ) or nebulizations of normal saline ( the control strategy ) every four hours for 14days or until extubation , whichever comes first .
-METHODS	The primary endpoint is the number of ventilator-free days , defined as days alive and breathing without assistance during the first 28days , if the period of unassisted breathing lasts for at least 24 consecutive hours .
-CONCLUSIONS	As far as the authors know , HEPBURN is the first randomized , placebo-controlled trial , powered to investigate whether local treatment with heparin shortens duration of ventilation of intubated and ventilated burn patients with inhalation trauma .
-BACKGROUND	NCT01773083 ( http://www.clinicaltrials.gov ) , registered on 16 January 2013 .
-BACKGROUND	Recruiting .
-BACKGROUND	Randomisation commenced on 1 January 2014 .
-
-###25384813
-OBJECTIVE	People are now living longer , but disability may affect the quality of those additional years of life .
-OBJECTIVE	We undertook a trial to assess whether case finding reduces disability among older primary care patients .
-METHODS	We conducted a cluster-randomized trial of the Brief Risk Identification Geriatric Health Tool ( BRIGHT ) among 60 primary care practices in New Zealand , assigning them to an intervention or control group .
-METHODS	Intervention practices sent a BRIGHT screening tool to older adults every birthday ; those with a score of 3 or higher were referred to regional geriatric services for assessment and , if needed , service provision .
-METHODS	Control practices provided usual care .
-METHODS	Main outcomes , assessed in blinded fashion , were residential care placement and hospitalization , and secondary outcomes were disability , assessed with Nottingham Extended Activities of Daily Living Scale ( NEADL ) , and quality of life , assessed with the World Health Organization Quality of Life scale , abbreviated version ( WHOQOL-BREF ) .
-RESULTS	All 8,308 community-dwelling patients aged 75 years and older were approached ; 3,893 ( 47 % ) participated , of whom 3,010 ( 77 % ) completed the trial .
-RESULTS	Their mean age was 80.3 ( SD 4.5 ) years , and 55 % were women .
-RESULTS	Overall , 88 % of the intervention group returned a BRIGHT tool ; 549 patients were referred .
-RESULTS	After 36 months , patients in the intervention group were more likely than those in the control group to have been placed in residential care : 8.4 % vs 6.2 % ( hazard ratio = 1.32 ; 95 % CI , 1.04-1 .68 ; P = .02 ) .
-RESULTS	Intervention patients had smaller declines in mean scores for physical health-related quality of life ( 1.6 vs 2.9 points , P = .007 ) and psychological health-related quality of life ( 1.1 vs 2.4 points , P = .005 ) .
-RESULTS	Hospitalization , disability , and use of services did not differ between groups , however .
-CONCLUSIONS	Our case-finding strategy was effective in increasing identification of older adults with disability , but there was little evidence of improved outcomes .
-CONCLUSIONS	Further research could trial stronger primary care integration strategies .
-
-###24434439
-OBJECTIVE	To investigate the effects of intensive atorvastatin therapy on programmed cell death 4 ( PDCD4 ) expression by CD4 + T lymphocytes in patients with unstable angina who received percutaneous coronary intervention ( PCI ) .
-METHODS	Patients with unstable angina were randomized to pretreatment with either an intensive dose ( 80 mg/day , n = 33 ) or a conventional dose ( 20 mg/day , n = 33 ) of atorvastatin .
-METHODS	Circulating CD4 + T cells were subsequently obtained prior to PCI , and also 18-24 h after PCI , using a magnetic cell sorting system .
-METHODS	Fluorescence-based quantitative real-time PCR was then used to measure levels of PDCD4 mRNA in the isolated CD4 + T lymphocytes , and Western blot analysis was used to detect levels of PDCD4 .
-METHODS	Serum levels of interleukin ( IL ) -10 and TNF - were quantified using enzyme-linked immunosorbent assays .
-RESULTS	Of the 66 patients with unstable angina that were examined , levels of PDCD4 mRNA and protein were found to dramatically decrease in patients who received an intensive dose of atorvastatin following PCI ( p < 0.05 ) .
-RESULTS	In contrast , serum levels of TNF - significantly increased following PCI in both the intensive dose group and the conventional dose group , with the latter being higher than the former ( p < 0.05 ) .
-RESULTS	Serum IL-10 levels also markedly increased following PCI for the two groups .
-RESULTS	However , higher values were associated with the intensive dose group ( p < 0.05 ) .
-CONCLUSIONS	Intensive atorvastatin treatment reduced the post-PCI myocardial inflammatory response in patients with unstable angina , possibly by inhibiting PDCD4 expression in CD4 + T lymphocytes .
-
-###24400719
-OBJECTIVE	A randomized and double-blinded study design was implemented to assess the stereo-acuity in patients symmetrically implanted with four types of multifocal intraocular lenses ( MIOLs ) , compared to a monofocal lens ( control group ) .
-OBJECTIVE	In addition , the influence of the type of test employed for the evaluation of stereo-acuity was explored .
-METHODS	Six months after cataract intervention , stereo-acuity was measured with the Titmus and TNO stereotests in 143 patients implanted with one of the following MIOL lens types : hybrid spherical SN60D3 , hybrid aspheric SN6AD1 , diffractive aspheric ZMA00 and refractive spherical NXG1 .
-METHODS	A control group implanted with the monofocal aspheric ZA9003 ( in which stereo-acuity was measured with a near addition ) was also included in the study .
-RESULTS	Statistically significant better stereo-acuity was found in the monofocal group with both stereotests ( except for the SN60D3 group with the Titmus test ) ( all p < 0.001 ) .
-RESULTS	No significant differences in stereo-acuity between MIOLs were found using the Titmus test .
-RESULTS	However , with the TNO , patients implanted with hybrid diffractive MIOLs exhibited statistically significant worse stereo-acuity than those with the refractive design ( SN60D3 , p < 0.001 ; SN6AD1 , p = 0.006 ) .
-CONCLUSIONS	Patients implanted with MIOLs have worse stereo-acuity than those implanted with monofocal IOLs due to the decrease in retinal image contrast originating in the simultaneous presence of two images .
-CONCLUSIONS	A wavelength-based stereotest such as the TNO induces large differences in image contrast between fellow eyes implanted with diffractive-based MIOLs , which may result in an underestimation of the real stereo-acuity of the patient .
-
-###24552184
-BACKGROUND	The effectiveness and durability of endovascular revascularization therapies for chronic critical limb ischemia ( CLI ) are challenged by the extensive burden of infrapopliteal arterial disease and lesion-related characteristics ( e.g. , severe calcification , chronic total occlusions ) , which frequently result in poor clinical outcomes .
-BACKGROUND	While infrapopliteal vessel patency directly affects pain relief and wound healing , sustained patency and extravascular care both contribute to the ultimate `` patient-centric '' outcomes of functional limb preservation , mobility and quality of life ( QoL ) .
-METHODS	IN.PACT DEEP is a 2:1 randomized controlled trial designed to assess the efficacy and safety of infrapopliteal arterial revascularization between the IN.PACT Amphirion paclitaxel drug-eluting balloon ( IA-DEB ) and standard balloon angioplasty ( PTA ) in patients with Rutherford Class 4-5-6 CLI .
-CONCLUSIONS	This multicenter trial has enrolled 358 patients at 13 European centers with independent angiographic core lab adjudication of the primary efficacy endpoint of target lesion late luminal loss ( LLL ) and clinically driven target lesion revascularization ( TLR ) in major amputation-free surviving patients through 12-months .
-CONCLUSIONS	An independent wound core lab will evaluate all ischemic wounds to assess the extent of healing and time to healing at 1 , 6 , and 12 months .
-CONCLUSIONS	A QoL questionnaire including a pain scale will assess changes from baseline scores through 12 months .
-CONCLUSIONS	A Clinical Events Committee and Data Safety Monitoring Board will adjudicate the composite primary safety endpoints of all-cause death , major amputation , and clinically driven TLR at 6 months and other trial endpoints and supervise patient safety throughout the study .
-CONCLUSIONS	All patients will be followed for 5 years .
-CONCLUSIONS	A literature review is presented of the current status of endovascular treatment of CLI with drug-eluting balloon and standard PTA .
-CONCLUSIONS	The rationale and design of the IN.PACT DEEP Trial are discussed .
-CONCLUSIONS	IN.PACT DEEP is a milestone , prospective , randomized , robust , independent core lab-adjudicated CLI trial that will evaluate the role of a new infrapopliteal revascularization technology , the IA-DEB , compared to PTA .
-CONCLUSIONS	It will assess the overall impact on infrapopliteal artery patency , limb salvage , wound healing , pain control , QoL , and patient mobility .
-CONCLUSIONS	The 1-year results of the adjudicated co-primary and secondary endpoints will be available in 2014 .
-BACKGROUND	NCT00941733 .
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-###24800582
-OBJECTIVE	To investigate the efficacy and safety of adjusting the doses of diuretics of different time in the treatment of advanced schistosomiasis ascites .
-METHODS	A total of 80 advanced schistosomiasis patients with ascites were randomly divided into an observation group and a control group ( 40 cases each ) .
-METHODS	The patients in the observation group received spironolactone and furosemide , and the first doses were 100 mg/d and 40 mg/d , respectively .
-METHODS	If the efficacy was poor , according to the first doses of the standard increments once every four days , the doses gradually increased to the maximum doses of spironolactone 400 mg/d and furosemide 160 mg/d , respectively .
-METHODS	The patients in the control group received spironolactone and furosemide , and the first doses were the same as those of the observation group .
-METHODS	If the efficacy was poor , according to the first doses of the standard increments once every seven days , the doses gradually increased to the maximum doses as those of the observation group .
-METHODS	Other conventional treatments were the same in both groups .
-RESULTS	In both groups , the reductions of the total amount of the weight were ( 5.62 + / - 1.28 ) kg and ( 5.42 + / - 1.37 ) kg respectively ; the time of efficacy beginning was ( 3.84 + / - 2.36 ) days and ( 4.65 + / - 2.86 ) days respectively ; the average daily amounts of weight loss were ( 0.41 + / - 0.16 ) kg and ( 0.35 + / - 0.11 ) kg respectively ; the efficient rates were 95 % and 92.5 % respectively ; and there were no significant differences between the two group ( all P > 0.05 ) .
-RESULTS	However , the time of reduction from moderate ascites to mild ascites was ( 10.70 + / - 3.01 ) days ( 6-20 days ) in the observation group and the time was ( 14.75 + / - 5.62 ) days ( 7-30 days ) in the control group ( u = 3.876 , P < 0.01 ) .
-CONCLUSIONS	The therapy of diuretic doses adjusted by a four-day cycle is more useful for advanced schistosomiasis patients with ascites .
-
-###24710621
-BACKGROUND	Preclinical studies suggest that stress potentiates cue-induced cocaine seeking and that this effect is more pronounced in females .
-BACKGROUND	These findings have not been characterized in clinical populations .
-OBJECTIVE	The objectives of this study were to examine the impact a pharmacological stressor , alpha-2 adrenergic receptor antagonist yohimbine , on the subjective , endocrine , and physiologic responses to drug-paired cues cocaine-dependent men and women .
-METHODS	In a double-blind placebo-controlled cross-over study , cocaine-dependent men ( n = 32 ) , cocaine-dependent women ( n = 30 ) , control men ( n = 32 ) , and control women ( n = 25 ) received either yohimbine or placebo prior to two cocaine cue exposure sessions .
-RESULTS	Yohimbine increased ratings of anxiety both before ( p < 0.001 ) and after ( p = 0.035 ) cues , and the post-cue increase in anxiety was more pronounced in women ( p = 0.001 ) .
-RESULTS	Yohimbine also significantly increased craving , compared with placebo ( p < 0.05 ) , following the cue presentation , and this effect was greater in women than men ( gender by treatment interaction ; p = 0.006 ) .
-RESULTS	Yohimbine also increased salivary cortisol ( p < 0.001 ) and dehydroepiandrosterone ( p = 0.003 ) levels , regardless of diagnostic group .
-RESULTS	Women had a significantly greater heart rate response following yohimbine as compared with men ( p < 0.001 ) .
-CONCLUSIONS	Stress may increase the salience of cocaine cues for cocaine-dependent women as compared with men .
-CONCLUSIONS	This suggests gender differences in vulnerability to craving and relapse under stressful conditions .
-
-###24613271
-OBJECTIVE	The effects of nutritional management among other intervention components have not been examined for hip-fractured elderly persons with poor nutritional status .
-OBJECTIVE	Accordingly , this study explored the intervention effects of an in-home program using a comprehensive care model that included a nutrition-management component on recovery of hip-fractured older persons with poor nutritional status at hospital discharge .
-METHODS	A secondary analysis of data from a randomized controlled trial with 24-month follow-up .
-METHODS	A 3000-bed medical center in northern Taiwan .
-METHODS	Subjects were included only if they had `` poor nutritional status '' at hospital discharge , including those at risk for malnutrition or malnourished .
-METHODS	The subsample included 80 subjects with poor nutritional status in the comprehensive care group , 87 in the interdisciplinary care group , and 85 in the usual care group .
-METHODS	The 3 care models were usual care , interdisciplinary care , and comprehensive care .
-METHODS	Usual care provided no in-home care , interdisciplinary care provided 4 months of in-home rehabilitation , and comprehensive care included management of depressive symptoms , falls , and nutrition as well as 1 year of in-home rehabilitation .
-METHODS	Data were collected on nutritional status and physical functions , including range of motion , muscle power , proprioception , balance and functional independence , and analyzed using a generalized estimating equation approach .
-METHODS	We also compared patients ' baseline characteristics : demographic characteristics , type of surgery , comorbidities , length of hospital stay , cognitive function , and depression .
-RESULTS	Patients with poor nutritional status who received comprehensive care were 1.67 times ( 95 % confidence interval 1.06-2 .61 ) more likely to recover their nutritional status than those who received interdisciplinary and usual care .
-RESULTS	Furthermore , the comprehensive care model improved the functional independence and balance of patients who recovered their nutritional status over the first year following discharge , but not of those who had not yet recovered .
-CONCLUSIONS	An in-home program using the comprehensive care model with a nutritional component effectively improved the nutritional status of hip-fractured patients with poor nutrition .
-CONCLUSIONS	This comprehensive care intervention more effectively improved recovery of functional independence and balance for patients with recovered nutritional status .
-
-###24397361
-OBJECTIVE	To determine the effect of vaginal progesterone as luteal support on pregnancy outcomes in infertile patients who undergo ovulation induction with gonadotropins and intrauterine insemination ( IUI ) .
-METHODS	Prospective randomized trial .
-METHODS	Tertiary referral center .
-METHODS	About 398 patients with primary infertility were treated during 893 ovarian stimulation and IUI cycles from February 2010 to September 2012 .
-METHODS	All patients underwent ovarian stimulation with gonadotropins combined with IUI .
-METHODS	Patients in the supported group received vaginal micronized progesterone capsules 200mg once daily from the day after insemination until next menstruation or continuing for up to 8 weeks of pregnancy .
-METHODS	Women allocated in the control group did not receive luteal phase support .
-METHODS	Livebirth rate , clinical pregnancy rate and early miscarriage rate per cycle .
-RESULTS	Of the 893 cycles , a total of 111 clinical pregnancies occurred .
-RESULTS	There were no significant differences between supported with progesterone and unsupported cycle in terms of livebirth rate ( 10.2 % versus 8.3 % , respectively , with a p value = 0.874 ) and clinical pregnancy rate ( 13.8 % compared with 11.0 % in unsupported cycle with a p value = 0.248 ) .
-RESULTS	An early miscarriage rate of 3.6 % was observed in the supported cycles and 2.7 % in the unsupported cycles , with no significant differences between the groups ( p value = 0.874 ) .
-CONCLUSIONS	In infertile patients treated with mildly ovarian stimulation with recombinant gonadotropins and IUI , luteal phase support with vaginal progesterone is not associated with higher livebirth rate or clinical pregnancy rate compared with patients who did not receive any luteal phase support .
-
-###24655871
-BACKGROUND	Post-burn hyperglycemia leads to graft failure , multiple organ failure , and death .
-BACKGROUND	A hyperinsulinemic-euglycemic clamp is used to keep serum glucose between 60 and 110 mg/dL .
-BACKGROUND	Because of frequent hypoglycemic episodes , a less-stringent sliding scale insulin protocol is used to maintain serum glucose levels between 80 and 160 mg/dL after elevations > 180 mg/dL .
-METHODS	We randomized pediatric patients with massive burns into 2 groups , patients receiving sliding scale insulin to lower blood glucose levels ( n = 145 ) and those receiving no insulin ( n = 98 ) , to determine the differences in morbidity and mortality .
-METHODS	Patients 0 to 18 years old with burns covering 30 % of the total body surface area and not randomized to receive anabolic agents were included in this study .
-METHODS	End points included glucose levels , infections , resting energy expenditure , lean body mass , bone mineral content , fat mass , muscle strength , and serum inflammatory cytokines , hormones , and liver enzymes .
-RESULTS	Maximal glucose levels occurred within 6 days of burn injury .
-RESULTS	Blood glucose levels were age dependent , with older children requiring more insulin ( p < 0.05 ) .
-RESULTS	Daily maximum and daily minimum , but not 6 am , glucose levels were significantly different based on treatment group ( p < 0.05 ) .
-RESULTS	Insulin significantly increased resting energy expenditure and improved bone mineral content ( p < 0.05 ) .
-RESULTS	Each additional wound infection increased incidence of hyperglycemia ( p = 0.004 ) .
-RESULTS	There was no mortality in patients not receiving insulin , only in patients who received insulin ( p < 0.004 ) .
-RESULTS	Muscle strength was increased in patients receiving insulin ( p < 0.05 ) .
-CONCLUSIONS	Burn-induced hyperglycemia develops in a subset of severely burned children .
-CONCLUSIONS	Length of stay was reduced in the no insulin group , and there were no deaths in this group .
-CONCLUSIONS	Administration of insulin positively impacted bone mineral content and muscle strength , but increased resting energy expenditure , hypoglycemic episodes , and mortality .
-CONCLUSIONS	New glucose-lowering strategies might be needed .
-
-###25815578
-OBJECTIVE	To determine the pharmacokinetics of doxycycline hyclate administered orally in the form of experimental formulations with different proportions of acrylic acid-polymethacrylate-based matrices .
-METHODS	30 healthy adult dogs .
-METHODS	In a crossover study , dogs were randomly assigned ( in groups of 10 ) to receive a single oral dose ( 20 mg/kg ) of doxycycline hyclate without excipients ( control ) or extended-release formulations ( ERFs ) containing doxycycline , acrylic acid polymer , and polymethacrylate in the following proportions : 1:0.5:0.0075 ( ERF1 ) or 1:1:0.015 ( ERF2 ) .
-METHODS	Serum concentrations of doxycycline were determined for pharmacokinetic analysis before and at several intervals after each treatment .
-RESULTS	Following oral administration to the study dogs , each ERF resulted in therapeutic serum doxycycline concentrations for 48 hours , whereas the control treatment resulted in therapeutic serum doxycycline concentrations for only 24 hours .
-RESULTS	All pharmacokinetic parameters for ERF1 and ERF2 were significantly different ; however , findings for ERF1 did not differ significantly from those for the control treatment .
-CONCLUSIONS	Results indicated that both ERFs containing doxycycline , acrylic acid polymer , and polymethacrylate had an adequate pharmacokinetic-pharmacodynamic relationship for a time-dependent drug and a longer release time than doxycycline alone following oral administration in dogs .
-CONCLUSIONS	Given the minimum effective serum doxycycline concentration of 0.26 g/mL , a dose interval of 48 hours can be achieved for each tested ERF .
-CONCLUSIONS	This minimum inhibitory concentration has the potential to be effective against several susceptible bacteria involved in important infections in dogs .
-CONCLUSIONS	Treatment of dogs with either ERF may have several benefits over treatment with doxycycline alone .
-
-###24962527
-BACKGROUND	This study compared mid-term functional and radiologic results of syndesmotic transfixation with no fixation in supination external rotation ( SER ) ankle fractures with intraoperatively confirmed syndesmosis disruption .
-BACKGROUND	Our hypothesis was that early-stage good functional results would remain and unfixed syndesmosis disruption in SER IV ankle fractures would not lead to an increased incidence of osteoarthritis .
-METHODS	A prospective study of 140 operatively treated patients with Lauge-Hansen SER IV ( Weber B ) ankle fractures was performed .
-METHODS	After bony fixation , the 7.5-Nm standardized external rotation stress test for both ankles was performed under fluoroscopy .
-METHODS	A positive stress examination was defined as a difference of more than 2 mm side-to-side in the tibiotalar or tibiofibular clear spaces on mortise radiographs .
-METHODS	The patients were randomized to either syndesmotic screw fixation ( 13 patients ) or no syndesmotic fixation ( 11 patients ) .
-METHODS	After a minimum of 4 years of follow-up ( mean , 58 months ) , ankle function and pain ( Olerud-Molander , a 100-mm visual analogue scale [ VAS ] for ankle function and pain ) and quality of life ( RAND-36 ) of all 24 patients were assessed .
-METHODS	Ankle joint congruity and osteoarthritis were assessed using mortise and lateral projection plain weight-bearing radiographs and magnetic resonance imaging ( MRI ; 3T ) scans .
-RESULTS	Improvement in Olerud-Molander score , VAS , and RAND-36 showed no significant difference between groups during the follow-up .
-RESULTS	In the syndesmotic transfixation group , improvements in all functional parameters and pain measurements were not significant , whereas in the group without syndesmotic fixation , the Olerud-Molander score improved from 84 to 93 ( P = .007 ) and the pain ( VAS ) score improved from 11 to 4 ( P = .038 ) from 1 year to last follow-up .
-RESULTS	X-ray or MRI imaging showed no difference between groups at the last follow-up visit .
-CONCLUSIONS	With the numbers available , no significant difference in functional outcome or radiologic findings could be detected between syndesmosis transfixation and no-fixation patients with SER IV ankle fracture after a minimum of 4 years of follow-up .
-METHODS	Level II , prospective comparative study .
-
-###24377217
-OBJECTIVE	To observe the impacts on post-stroke spastic hemiplegia treated with temporal three-needle therapy , spastic three-needle therapy , and rehabilitative therapy as well as combined application .
-METHODS	One hundred cases were randomized into a Jin 's three-needle group ( 35 cases ) , a rehabilitation group ( 33 cases ) and a combined therapy group ( 32 cases ) .
-METHODS	Beside the basic treatment , the acupuncture therapy of temporal three-needle and spastic three-needle techniques , rehabilitation training , and the combined therapy of acupuncture and rehabilitation were applied in the Jin 's three-needle group , the rehabilitation group and the combined therapy group , respectively .
-METHODS	Before treatment , in 7 days and 14 days of treatment , the functional comprehensive assessment scale ( FCA ) , clinical neurological defect score ( NDS ) , four-limb simplified Fugl-Meyer assessment ( FMA ) and clinical spasm index ( CSI ) were adopted to assess the spastic degree and limb function , respectively .
-RESULTS	In terms of FCA , NDS and FMA , in 7 days of treatment , except the rehabilitation group , the results in the other two groups were all improved as compared with those before treatment ( all P < 0.05 ) .
-RESULTS	The results in the Jin 's three-needle group and the combined therapy group were better than those in the rehabilitation group ( all P < 0.05 ) .
-RESULTS	In 14 days of treatment , the results in the three groups were improved as compared with those before treatment and in 7 days of treatment ( P < 0.05 , P < 0.01 ) .
-RESULTS	The results in the combined therapy group were better than those in the other two groups ( all P < 0.05 ) .
-RESULTS	Regarding CSI assessment , in 7 days of treatment , the results of the three groups were all improved significantly as compared with those before treatment ( P < 0.05 , P < 0.01 ) , and the results in the combined therapy group were better than those in the other two groups ( all P < 0.05 ) .
-RESULTS	In 14 days of treatment , CSI scores were further improved in the three groups , but the difference was not significant in comparison ( all P > 0.05 ) .
-CONCLUSIONS	The Jin 's three-needle therapy , rehabilitation therapy and the combined application all relieve the symptoms of post-stroke spastic hemiplegia .
-CONCLUSIONS	The effect in the Jin 's three-needle group and the combined therapy group is achieved in 7 days of treatment , which is better than that in the rehabilitation group .
-CONCLUSIONS	The combined therapy a chieves the best effect on spasm in comparison with the single therapy .
-
-###24386900
-BACKGROUND	The ` Older People 's Exercise intervention in Residential and nursing Accommodation ' ( OPERA ) cluster randomised trial evaluated the impact of training for care home staff together with twice-weekly , physiotherapist-led exercise classes on depressive symptoms in care home residents , but found no effect .
-BACKGROUND	We report a process evaluation exploring potential explanations for the lack of effect .
-METHODS	The OPERA trial included over 1,000 residents in 78 care homes in the UK .
-METHODS	We used a mixed methods approach including quantitative data collected from all homes .
-METHODS	In eight case study homes , we carried out repeated periods of observation and interviews with residents , care staff and managers .
-METHODS	At the end of the intervention , we held focus groups with OPERA research staff .
-METHODS	We reported our first findings before the trial outcome was known .
-RESULTS	Homes showed large variations in activity at baseline and throughout the trial .
-RESULTS	Overall attendance rate at the group exercise sessions was low ( 50 % ) .
-RESULTS	We considered two issues that might explain the negative outcome : whether the intervention changed the culture of the homes , and whether the residents engaged with the intervention .
-RESULTS	We found low levels of staff training , few home champions for the intervention and a culture that prioritised protecting residents from harm over encouraging activity .
-RESULTS	The trial team delivered 3,191 exercise groups but only 36 % of participants attended at least 1 group per week and depressed residents attended significantly fewer groups than those who were not depressed .
-RESULTS	Residents were very frail and therefore most groups only included seated exercises .
-CONCLUSIONS	The intervention did not change the culture of the homes and , in the case study homes , activity levels did not change outside the exercise groups .
-CONCLUSIONS	Residents did not engage in the exercise groups at a sufficient level , and this was particularly true for those with depressive symptoms at baseline .
-CONCLUSIONS	The physical and mental frailty of care home residents may make it impossible to deliver a sufficiently intense exercise intervention to impact on depressive symptoms .
-
-###24330983
-OBJECTIVE	To compare the effect of different types and concentrations of sweet solutions on neonatal pain during heel lance procedure .
-METHODS	Totally 560 full term neonates ( male 295 , female 265 ) were randomized into 7 groups : placebo group ( plain water ) , 10 % glucose , 25 % glucose , 50 % glucose , 12 % sucrose , 24 % sucrose and 30 % sucrose groups.In each group , 2 ml corresponding oral solutions were administered through a syringe by dripping into the neonate 's mouth 2 minute before heel lance .
-METHODS	The procedure process was recorded by videos , from which to collect heart rate , oxygen saturation and pain score 1 min before puncture , 3 , 5 and 10 min after puncture .
-RESULTS	The average heart rate increase 3 , 5 and 10 min after procedure in the 25 % and 50 % glucose groups , 12 % and 24 % and 30 % sucrose groups was significantly lower than those in the placebo group ( P < 0.01 or 0.05 ) .
-RESULTS	The average heart rate increase 3 min after procedure in the sucrose group was lower than that in the glucose group ( P < 0.01 ) .
-RESULTS	Neonates who received 30 % sucrose has a significantly lower average heart rate increase than those who received 12 % and 24 % sucrose 3 min after heel lance ( both P < 0.05 ) .
-RESULTS	The average oxygen saturation decrease 3 , 5 , 10 min after procedure was significantly lower than those in the placebo group ( P < 0.01 ) .
-RESULTS	The average oxygen saturation decrease 3 min after procedure in the sucrose groups was significantly lower than that in the glucose groups ( P < 0.01 ) .
-RESULTS	The average pain score 3 , 5 , 10 min after procedure was significantly lower than those in the placebo group ( P < 0.01 ) .
-RESULTS	The average pain score 3 min after procedure in the sucrose groups was significantly lower than that in the glucose groups ( P < 0.01 ) .
-CONCLUSIONS	Oral administration of sweet solutions is an effective way to relieve neonatal pain on procedure , and sucrose has a better pain relief action than glucose , moreover , 30 % sucrose provides better effect in control of heart rate increase 3 min after heel lance , but the best concentration of sucrose for pain relief needs further study .
-
-###25287828
-OBJECTIVE	To compare epirubicin , cisplatin , and capecitabine ( ECX ) with fluorouracil , leucovorin , and irinotecan ( FOLFIRI ) as first-line treatments in patients with advanced gastric or esophagogastric junction ( EGJ ) adenocarcinoma .
-METHODS	This open , randomized , phase III study was carried out in 71 centers .
-METHODS	Patients with locally advanced or metastatic gastric or EGJ cancer were randomly assigned to receive either ECX as first-line treatment ( ECX arm ) or FOLFIRI ( FOLFIRI arm ) .
-METHODS	Second-line treatment was predefined ( FOLFIRI for the ECX arm and ECX for the FOLFIRI arm ) .
-METHODS	The primary criterion was time-to-treatment failure ( TTF ) of the first-line therapy .
-METHODS	Secondary criteria were progression-free survival ( PFS ) , overall survival ( OS ) , toxicity , and quality of life .
-RESULTS	In all , 416 patients were included ( median age , 61.4 years ; 74 % male ) .
-RESULTS	After a median follow-up of 31 months , median TTF was significantly longer with FOLFIRI than with ECX ( 5.1 v 4.2 months ; P = .008 ) .
-RESULTS	There was no significant difference between the two groups in median PFS ( 5.3 v 5.8 months ; P = .96 ) , median OS ( 9.5 v 9.7 months ; P = .95 ) , or response rate ( 39.2 % v 37.8 % ) .
-RESULTS	First-line FOLFIRI was better tolerated ( overall rate of grade 3 to 4 toxicity , 69 % v 84 % ; P < .001 ; hematologic adverse events [ AEs ] , 38 % v 64.5 % ; P < .001 ; nonhematologic AEs : 53 % v 53.5 % ; P = .81 ) .
-CONCLUSIONS	FOLFIRI as first-line treatment for advanced gastric and EGJ cancer demonstrated significantly better TTF than did ECX .
-CONCLUSIONS	Other outcome results indicate that FOLFIRI is an acceptable first-line regimen in this setting and should be explored as a backbone regimen for targeted agents .
-
-###24758078
-OBJECTIVE	To observe the effect of Ginkgo Leaves Tablet ( GLT ) on memory quotient ( MQ ) of mild cognitive impairment ( MCI ) patients .
-METHODS	One hundred and thirteen patients were randomly assigned to the control group ( 55 cases ) and the treatment group ( 58 cases ) .
-METHODS	Patients in the control group received dietetic therapy and physical exercises , while those in the treatment group additionally took GLT , 19.2 mg each time , three times daily .
-METHODS	The treatment course was 12 months for all .
-METHODS	The MQ of all the patients was assessed by WMS-RC before treatment , at 6-month of treatment , and 12-month of treatment .
-RESULTS	Compared with the control group , the improvement of MQ increased in the treatment group 0.5 and 1 year after treatment ( P < 0.05 ) .
-RESULTS	The clinical efficiency of MQ obviously increased in the treatment group ( 48.28 % and 50.00 % ) , showing statistical difference when compared with the control group ( 30.91 % and 27.27 % , P < 0.05 , P < 0.01 ) .
-RESULTS	There was statistical difference in added scores of recognition , regeneration , understanding , and recitation test at 6-month of treatment and 12-month of treatment between the treatment group and the control group ( P < 0.05 , P < 0.01 ) .
-CONCLUSIONS	GLT was effective in improving MQ of MCI patients , especially in improving recognition , regeneration , understanding , and recitation test .
-
-###25460259
-OBJECTIVE	The current study is the first to examine whether reactivation of fear memory prior to exposure therapy reduces relapse in a randomized clinical sample .
-METHODS	In a standardized treatment protocol combining virtual reality and in-vivo exposure , patients underwent a fear reactivation procedure using a virtual spider 10 min prior to a virtual reality ( VR ) exposure ( reactivation group : RG , n = 15 ) .
-METHODS	A control group ( CG , n = 17 ) was exposed to a virtual plant 10 min prior to the VR exposure .
-METHODS	Outcome measures were a VR spontaneous recovery test ( SRT ) and in-vivo a behavioral avoidance test assessed 24 h after VR exposure .
-METHODS	One week later an in-vivo exposure session followed .
-METHODS	Additionally , a follow-up using psychometric assessment was conducted six months after the first session .
-RESULTS	Both groups benefitted significantly and equally from the combined treatment , and importantly , the SRT revealed no return of fear in both groups .
-RESULTS	Furthermore , follow-up tests showed long-term treatment effects with no group differences .
-CONCLUSIONS	Due to different study components ( VR treatment and in-vivo ) , we were not able to determine which treatment module was mainly responsible for the long-term treatment effect .
-CONCLUSIONS	Furthermore , no direct measure of memory destabilization was possible in this study .
-CONCLUSIONS	Our treatment package was highly effective in reducing phobic fear up to 6 months following treatment .
-CONCLUSIONS	Explicit fear reactivation prior to exposure was not beneficial in VR exposure treatment , possibly due to a failure to induce a memory destabilization or due to an implicit fear reactivation prior to treatment in both groups .
-
-###24758164
-BACKGROUND	Antibiotic prescribing in dentistry accounts for 9 % of total antibiotic prescriptions in Scottish primary care .
-BACKGROUND	The Scottish Dental Clinical Effectiveness Programme ( SDCEP ) published guidance in April 2008 ( 2nd edition , August 2011 ) for Drug Prescribing in Dentistry , which aims to assist dentists to make evidence-based antibiotic prescribing decisions .
-BACKGROUND	However , wide variation in prescribing persists and the overall use of antibiotics is increasing .
-METHODS	RAPiD is a 12-month partial factorial cluster randomised trial conducted in NHS General Dental Practices across Scotland .
-METHODS	Its aim is to compare the effectiveness of individualised audit and feedback ( A&F ) strategies for the translation into practice of SDCEP recommendations on antibiotic prescribing .
-METHODS	The trial uses routinely collected electronic healthcare data in five aspects of its design in order to : identify the study population ; apply eligibility criteria ; carry out stratified randomisation ; generate the trial intervention ; analyse trial outcomes .
-METHODS	Eligibility was determined on contract status and a minimum level of recent NHS treatment provision .
-METHODS	All eligible dental practices in Scotland were simultaneously randomised at baseline either to current audit practice or to an intervention group .
-METHODS	Randomisation was stratified by single-handed/multi-handed practices .
-METHODS	General dental practitioners ( GDPs ) working at intervention practices will receive individualised graphical representations of their antibiotic prescribing rate from the previous 14 months at baseline and an update at six months .
-METHODS	GDPs could not be blinded to their practice allocation .
-METHODS	Intervention practices were further randomised using a factorial design to receive feedback with or without : a health board comparator ; a supplementary text-based intervention ; additional feedback at nine months .
-METHODS	The primary outcome is the total antibiotic prescribing rate per 100 courses of treatment over the year following delivery of the baseline intervention .
-METHODS	A concurrent qualitative process evaluation will apply theory-based approaches using the Consolidated Framework for Implementation Research to explore the acceptability of the interventions and the Theoretical Domains Framework to identify barriers and enablers to evidence-based antibiotic prescribing behaviour by GDPs .
-CONCLUSIONS	RAPiD will provide a robust evaluation of A&F in dentistry in Scotland .
-CONCLUSIONS	It also demonstrates that linked administrative datasets have the potential to be used efficiently and effectively across all stages of an randomised controlled trial .
-BACKGROUND	Current Controlled Trials ISRCTN49204710 .
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-###26099868
-OBJECTIVE	To evaluate the efficacy of tramadol , lidocaine , and a combination of tramadol with lidocaine in pain relief using periprostatic nerve block technique by guidance of transrectal ultrasound ( TRUS ) before the prostate biopsy ( PBx ) .
-METHODS	For the indication of TRUS-PBx , the patients with a prostate-specific antigen ( PSA ) level > 4.0 ng/mL or abnormal digital examination findings were selected .
-METHODS	The patients were randomized through random method .
-METHODS	Group 1 : patients were administered 5 mL of 2 % lidocaine ; group 2 : patients were administered 5 mL of 25-mg tramadol ; and group 3 : patients were administered 5 mL of 2 % lidocaine + 25-mg tramadol .
-METHODS	The procedures were completed in 10 minutes , and a visual pain scale was administered to the patients to question the pain severity .
-RESULTS	TRUS-guided PBx was performed in 60 patients with an age range of 57-77 years ( mean age , 66.2 7.49 years ) and a PSA range of 1-1000 ng/mL .
-RESULTS	The mean PSA level of the groups was 28.5 ( 7.5 ) , 16.1 ( 5.0 ) , and 14.9 ( 2.9 ) ng/mL , respectively .
-RESULTS	The postprocedural pain scores by visual pain scale were 4.6 1.2 , 5.4 1.2 , and 3.6 0.9 in lidocaine , tramadol , and lidocaine + tramadol groups , respectively .
-CONCLUSIONS	Periprostatic nerve block is the current golden standard method owing to pain management and comfort provided , independent of the patient age and the number of core biopsies .
-CONCLUSIONS	We suggest that tramadol may also be used in this field to achieve better pain management by improving lidocaine 's effect or as an alternative to lidocaine .
-
-###25525672
-BACKGROUND	While Web-based interventions have been shown to assist a wide range of patients successfully in managing their illness , few studies have examined the relative contribution of different Web-based components to improve outcomes .
-BACKGROUND	Further efficacy trials are needed to test the effects of Web support when offered as a part of routine care .
-OBJECTIVE	Our aim was to compare in regular care the effects of ( 1 ) an Internet-based patient provider communication service ( IPPC ) , ( 2 ) WebChoice , a Web-based illness management system for breast cancer patients ( IPPC included ) , and ( 3 ) usual care on symptom distress , anxiety , depression , ( primary outcomes ) , and self-efficacy ( secondary outcome ) .
-OBJECTIVE	This study reports preliminary findings from 6 months ' follow-up data in a 12-month trial .
-METHODS	We recruited 167 patients recently diagnosed with breast cancer and undergoing treatment from three Norwegian hospitals .
-METHODS	The nurse-administered IPPC allowed patients to send secure e-messages to and receive e-messages from health care personnel at the hospital where they were treated .
-METHODS	In addition to the IPPC , WebChoice contains components for symptom monitoring , tailored information and self-management support , a diary , and communication with other patients .
-METHODS	A total of 20 care providers ( 11 nurses , 6 physicians , and 3 social workers ) were trained to answer questions from patients .
-METHODS	Outcomes were measured with questionnaires at study entry and at study months 2 , 4 , and 6 .
-METHODS	Linear mixed models for repeated measures were fitted to compare effects on outcomes over time .
-RESULTS	Patients were randomly assigned to the WebChoice group ( n = 64 ) , the IPPC group ( n = 45 ) , or the usual care group ( n = 58 ) .
-RESULTS	Response rates to questionnaires were 73.7 % ( 123/167 ) at 2 months , 65.9 ( 110/167 ) at 4 months , and 62.3 % ( 104/167 ) at 6 months .
-RESULTS	Attrition was similar in all study groups .
-RESULTS	Among those with access to WebChoice , 64 % ( 41/64 ) logged on more than once and 39 % ( 25/64 ) sent e-messages to care providers .
-RESULTS	In the IPPC group , 40 % ( 18/45 ) sent e-messages .
-RESULTS	Linear mixed models analyses revealed that the WebChoice group reported significantly lower symptom distress ( mean difference 0.16 , 95 % CI 0.06-0 .25 , P = .001 ) , anxiety ( mean difference 0.79 , 95 % CI 0.09-1 .49 , P = .03 ) , and depression ( mean difference 0.79 , 95 % CI 0.09-1 .49 , P = .03 ) compared with the usual care group .
-RESULTS	The IPPC group reported significant lower depression scores compared with the usual care group ( mean difference 0.69 , 95 % CI 0.05-1 .32 , P = .03 ) , but no differences were observed for symptom distress or anxiety .
-RESULTS	No significant differences in self-efficacy were found among the study groups .
-CONCLUSIONS	In spite of practice variations and moderate use of the interventions , our results suggest that offering Web support as part of regular care can be a powerful tool to help patients manage their illness .
-CONCLUSIONS	Our finding that a nurse-administered IPPC alone can significantly reduce depression is particularly promising .
-CONCLUSIONS	However , the multicomponent intervention WebChoice had additional positive effects .
-BACKGROUND	Clinicaltrials.gov : NCT00971009 ; http://clinicaltrials.gov/show/NCT00971009 ( Archived by WebCite at http://www.webcitation.org/6USKezP0Y ) .
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-###24345827
-OBJECTIVE	The aim of the study was to assess the impact of LYM-X-SORB ( LXS ) , an organized lipid matrix that has been shown to be absorbable without pancreatic enzyme therapy on fat-soluble vitamin status in children with cystic fibrosis ( CF ) and pancreatic insufficiency ( PI ) .
-METHODS	Children with CF and PI were randomized to daily LXS or an isocaloric placebo comparison supplement for 12 months .
-METHODS	Serum vitamins A ( retinol ) , D ( 25-hydroxyvitamin D [ 25D ] ) , E ( - tocopherol , - tocopherol : cholesterol ratio ) , and K ( percentage of undercarboxylated osteocalcin [ % ucOC ] and plasma proteins induced by vitamin K absence factor II [ PIVKA II ] ) were assessed at baseline and 12 months .
-METHODS	Dietary intake was determined using 3-day weighed food records and supplemental vitamin intake by a comprehensive questionnaire .
-RESULTS	A total of 58 subjects ( 32 boys , age 10.3 2.9 years [ mean standard deviation ] ) with complete serum vitamin , dietary and supplemental vitamin data were analyzed .
-RESULTS	After adjusting for dietary and supplemental vitamin intake , serum retinol increased 3.0 1.4 g/dL ( coefficient standard error ) ( adjusted R2 = 0.02 , P = 0.03 ) and vitamin K status improved as demonstrated by a decreased percentage of undercarboxylated osteocalcin of -6.0 % 1.6 % by 12 months ( adjusted R2 = 0.15 , P < 0.001 ) .
-RESULTS	These changes occurred in both the LXS and placebo comparison groups .
-RESULTS	No changes in serum 25D or - tocopherol were detected .
-RESULTS	Both nutrition interventions increased caloric intake a mean of 83 666 kcal/day by 12 months .
-CONCLUSIONS	Vitamins A and K status improved , whereas vitamins D and E status was unchanged during 12 months of LXS and isocaloric placebo comparison supplement in children with CF and PI .
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-###24596458
-BACKGROUND	The purpose of this study was to assess the effectiveness of a multifactorial intervention to reduce falls among the oldest-old people , including individuals with cognitive impairment or comorbidities .
-METHODS	A randomized , single-blind , parallel-group clinical trial was conducted from January 2009 to December 2010 in seven primary health care centers in Baix Llobregat ( Barcelona ) .
-METHODS	Of 696 referred people who were born in 1924 , 328 were randomized to an intervention group or a control group .
-METHODS	The intervention model used an algorithm and was multifaceted for both patients and their primary care providers .
-METHODS	Primary outcomes were risk of falling and time until falls .
-METHODS	Data analyses were by intention-to-treat .
-RESULTS	Sixty-five ( 39.6 % ) subjects in the intervention group and 48 ( 29.3 % ) in the control group fell during follow-up .
-RESULTS	The difference in the risk of falls was not significant ( relative risk 1.28 , 95 % confidence interval [ CI ] 0.94-1 .75 ) .
-RESULTS	Cox regression models with time from randomization to the first fall were not significant .
-RESULTS	Cox models for recurrent falls showed that intervention had a negative effect ( hazard ratio [ HR ] 1.46 , 95 % CI 1.03-2 .09 ) and that functional impairment ( HR 1.42 , 95 % CI 0.97-2 .12 ) , previous falls ( HR 1.09 , 95 % CI 0.74-1 .60 ) , and cognitive impairment ( HR 1.08 , 95 % CI 0.72-1 .60 ) had no effect on the assessment .
-CONCLUSIONS	This multifactorial intervention among octogenarians , including individuals with cognitive impairment or comorbidities , did not result in a reduction in falls .
-CONCLUSIONS	A history of previous falls , disability , and cognitive impairment had no effect on the program among the community-dwelling subjects in this study .
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-###24775991
-BACKGROUND	There is a need to identify novel pharmacologic targets to treat alcoholism .
-BACKGROUND	Animal and human studies suggest a role for ghrelin in the neurobiology of alcohol dependence and craving .
-BACKGROUND	Here , we were the first to test the hypothesis that intravenous administration of exogenous ghrelin acutely increases alcohol craving .
-METHODS	This was a double-blind , placebo-controlled human laboratory proof-of-concept study .
-METHODS	Nontreatment-seeking , alcohol-dependent , heavy-drinking individuals were randomized to receive intravenous ghrelin 1 mcg/kg , 3 mcg/kg or 0 mcg/kg ( placebo ) , followed by a cue-reactivity procedure , during which participants were exposed to neutral ( juice ) and alcohol cues .
-METHODS	The primary outcome variable was the increase in alcohol craving ( also called urge ) for alcohol , assessed by the Alcohol Visual Analogue Scale .
-RESULTS	Out of 103 screenings , 45 individuals received the study drug .
-RESULTS	Repeated measures of analysis of covariance revealed a group effect across ghrelin doses in increasing alcohol craving ( p < .05 ) .
-RESULTS	A dose-specific examination revealed a significant effect of ghrelin 3 mcg/kg versus placebo in increasing alcohol craving ( p < .05 ) with a large effect size ( d = .94 ) .
-RESULTS	By contrast , no significant ghrelin effect was found in increasing either urge to drink juice or food craving ( p = ns ) .
-RESULTS	No significant differences in side effects were found ( p = ns ) .
-CONCLUSIONS	Intravenous administration of exogenous ghrelin increased alcohol craving in alcohol-dependent heavy-drinking individuals .
-CONCLUSIONS	Although the small sample requires confirmatory studies , these findings provide preliminary evidence that ghrelin may play a role in the neurobiology of alcohol craving , thus demonstrating a novel pharmacologic target for treatment .
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-###24597699
-BACKGROUND	Various treatments are available for reducible unstable fractures of the distal radius , such as closed reduction combined with fixation by external fixator ( EF ) , and rigid internal fixation using a locked volar plate ( VP ) .
-BACKGROUND	Although there are studies comparing these methods , there is no conclusive evidence indicating which treatment is best .
-BACKGROUND	The hypothesis of this study is that surgical treatment with a VP is more effective than EF from the standpoint of functional outcome ( patient-reported ) .
-METHODS	The study is randomized clinical trial with parallel groups and a blinded evaluator and involves the surgical interventions EF and VP .
-METHODS	Patients will be randomly assigned ( assignment ratio 1:1 ) using sealed opaque envelopes .
-METHODS	This trial will include consecutive adult patients with an acute ( up to 15 days ) displaced , unstable fracture of the distal end of the radius of type A2 , A3 , C1 , C2 or C3 by the Arbeitsgemeinschaft fr Osteosynthesefragen-Association for the Study of Internal Fixation classification and type II or type III by the IDEAL32 classification , without previous surgical treatments of the wrist .
-METHODS	The surgical intervention assigned will be performed by three surgical specialists familiar with the techniques described .
-METHODS	Evaluations will be performed at 2 , and 8 weeks , 3 , 6 and 12 months , with the primary outcomes being measured by the Disabilities of the Arm , Shoulder and Hand ( DASH ) questionnaire and measurement of pain ( Visual Analog Pain Scale and digital algometer ) .
-METHODS	Secondary outcomes will include radiographic parameters , objective functional evaluation ( goniometry and dynamometry ) , and the rate of complications and method failure according to the intention-to-treat principle .
-METHODS	Final postoperative evaluations ( 6 and 12 months ) will be performed by independent blinded evaluators .
-METHODS	For the Student 's t-test , a difference of 10 points in the DASH score , with a 95 % confidence interval , a statistical power of 80 % , and 20 % sampling error results in 36 patients per group .
-CONCLUSIONS	Results from this study protocol will improve the current evidence regarding to the surgical treatment these fractures .
-BACKGROUND	ISCRTN09599740 .
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-###25733627
-BACKGROUND	Excess sodium intake is associated with high blood pressure , a major risk factor for cardiovascular disease ( CVD ) .
-BACKGROUND	It is unknown whether decreasing sodium intake to < 2300 mg/d has an effect on CVD or all-cause mortality .
-OBJECTIVE	The objective was to assess whether reductions in sodium intake to < 2300 mg/d were associated with either an increased or a decreased risk of fatal and nonfatal CVD and all-cause mortality .
-METHODS	This observational prospective study of the PREvencin con DIeta MEDiterrnea ( PREDIMED ) trial included 3982 participants at high CVD risk .
-METHODS	Sodium intake was evaluated with a validated food-frequency questionnaire and categorized as low ( < 1500 mg/d ) , intermediate ( 1500 to 2300 mg/d ) , high ( > 2300 to 3400 mg/d ) , or very high ( > 3400 mg/d ) .
-METHODS	Subsequently , 1-y and 3-y changes in sodium intake were calculated .
-METHODS	Multivariate relative risks were assessed by using Cox proportional hazards ratios .
-METHODS	Marginal structural models with inverse probability weighting were used to test the effect of changes in sodium intake and the Mediterranean diet ( MedDiet ) .
-RESULTS	We documented 125 CVD events and 131 deaths after a 4.8-y median follow-up .
-RESULTS	Sodium intake < 2300 mg/d was associated with a lower risk of all-cause mortality : 48 % ( HR : 0.52 ; 95 % CI : 0.30 , 0.91 ; P = 0.02 ) and 49 % ( HR : 0.51 ; 95 % CI : 0.26 , 0.98 ; P = 0.04 ) after 1 and 3 y , respectively .
-RESULTS	Increasing sodium intake after 1 y was associated with a 72 % ( HR : 1.72 ; 95 % CI : 1.01 , 2.91 ; P = 0.04 ) higher risk of CVD events .
-RESULTS	The incidence rate of CVD was reduced for those who reduced their sodium intake and were randomly assigned to MedDiet interventions [ 4.1 / 10,000 ( 95 % CI : 3.1 , 8.0 ) compared with 4.4 / 10,000 ( 95 % CI : 2.7 , 12.4 ) person-years ; P = 0.002 ] .
-CONCLUSIONS	Decreasing sodium intake to < 2300 mg/d was associated with a reduced risk of all-cause mortality , whereas increasing the intake to > 2300 mg/d was associated with a higher risk of CVD .
-CONCLUSIONS	Our observational data suggest that sodium intake < 2300 mg/d was associated with an enhanced beneficial effect of the MedDiet on CVD .
-CONCLUSIONS	These results should be interpreted with caution , and other confirmatory studies are necessary .
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-###24952855
-BACKGROUND	In patients with ST-segment elevation myocardial infarction ( STEMI ) who undergo primary percutaneous coronary intervention ( pPCI ) , the use of dual antiplatelet therapy is essential to prevent atherothrombotic complications .
-BACKGROUND	Therefore , patients are treated with acetylsalicylic acid and clopidogrel , prasugrel , or ticagrelor .
-BACKGROUND	Clopidogrel , however , shows a major interindividual variation in antiplatelet effect , which is correlated to an increase in atherothrombotic events in patients with high platelet reactivity .
-BACKGROUND	This interindividual variation is partly a result of CYP2C19 genetic variants .
-BACKGROUND	Ticagrelor and prasugrel reduce atherothrombotic events but increase bleeding rate and drug costs , as compared with clopidogrel .
-BACKGROUND	CYP2C19-based tailoring of antiplatelet therapy might be beneficial to STEMI patients .
-METHODS	POPular Genetics ( NCT01761786 ) is a randomized , open-label , multicenter trial involving 2,700 STEMI patients who undergo pPCI .
-METHODS	Patients are randomized to CYP2C19 genotyping or routine ticagrelor or prasugrel treatment .
-METHODS	In the genotyping group , * 1 / * 1 ( wild-type ) patients receive clopidogrel , and patients carrying 1 or 2 * 2 or * 3 loss-of-function alleles receive ticagrelor or prasugrel .
-METHODS	The primary net clinical benefit end point is the composite of death , ( recurrent ) myocardial infarction , definite stent thrombosis , stroke , and Platelet Inhibition and Patient Outcomes ( PLATO ) major bleeding at 1 year .
-METHODS	Primary safety end point is the composite of ( PLATO ) major and minor bleeding .
-METHODS	Cost-effectiveness and quality of life will be assessed by calculating quality-adjusted life-years , net costs per life-year , and per quality-adjusted life-year gained .
-CONCLUSIONS	The POPular Genetics study is the first large-scale trial comparing CYP2C19 genotype-guided antiplatelet therapy to a nontailored strategy in terms of net clinical benefit , safety , and cost-effectiveness .
-
-###24280999
-BACKGROUND	Head and neck cancer ( HNC ) patients are prone to have a poor health-related quality of life after cancer treatment .
-BACKGROUND	This study investigated the effect of the nurse counselling and after intervention ( NUCAI ) on the health-related quality of life and depressive symptoms of HNC patients between 12 and 24 months after cancer treatment .
-METHODS	Two hundred and five HNC patients were randomly allocated to NUCAI ( N = 103 ) or usual care ( N = 102 ) .
-METHODS	The 12-month nurse-led NUCAI is problem-focused and patient-driven and aims to help HNC patients manage with the physical , psychological and social consequences of their disease and its treatment .
-METHODS	Health-related quality of life was evaluated with the EORTC QLQ-C30 and QLQ H&N 35 .
-METHODS	Depressive symptoms were evaluated with the CES-D .
-RESULTS	At 12 months the intervention group showed a significant ( P < 0.05 ) improvement in emotional and physical functioning , pain , swallowing , social contact , mouth opening and depressive symptoms .
-RESULTS	At 18 months , global quality of life , role and emotional functioning , pain , swallowing , mouth opening and depressive symptoms were significantly better in the intervention group than in the control group , and at 24 months emotional functioning and fatigue were significantly better in the intervention group .
-CONCLUSIONS	The NUCAI effectively improved several domains of health-related quality of life and depressive symptoms in HNC patients and would seem a promising intervention for implementation in daily clinical practice .
-
-###25001020
-OBJECTIVE	To compare the efficacy and safety of the levonorgestrel-releasing intrauterine device ( LNG-IUD ) with dydrogesterone applied for the same duration in patients having endometrial hyperplasia ( EH ) without atypia .
-METHODS	One hundred thirty eight women aged between 30 and 50 years with abnormal uterine bleeding and diagnosed as EH by transvaginal ultrasound were randomized to receive either LNG-IUD or dydrogesterone for 6 months .
-METHODS	Primary outcome measures were regression of hyperplasia after 6 months of therapy .
-METHODS	Secondary outcome measures were occurrence of side effects during treatment or recurrence of hyperplasia during follow-up period .
-RESULTS	After 6 months of treatment , regression of EH occurs in 96 % of women in the levonorgestrel-releasing intrauterine system ( LNG-IUS ) group versus 80 % of women in the oral group ( P < .001 ) .
-RESULTS	Adverse effects were relatively common with minimal differences between the 2 groups .
-RESULTS	Intermenstrual vaginal spotting and amenorrhea were more common in the LNG-IUD group ( P value .01 and .0001 ) .
-RESULTS	Patient satisfaction was significantly higher in the LNG-IUS group ( P value .0001 ) .
-RESULTS	Hysterectomy rates were lower in the LNG-IUS group than in the oral group ( P = .001 ) .
-RESULTS	Recurrence rate was 0 % in the LNG-IUD group compared to 12.5 % in the oral group .
-CONCLUSIONS	In management of EH without atypia , LNG-IUS achieves a higher regression and a lower hysterectomy rate than oral progesterone and could be used as a first-line therapy .
-
-###26427105
-OBJECTIVE	To observe the effect of Sancaijiangtang powders on plasma nitric oxide and endothelin-1 levels .
-OBJECTIVE	We sought to identify the common pathological link and mechanism of action for Traditional Chinese medicine in type 2 diabetes mellitus and vascular dementia , and to explicate the material basis for treating the different diseases with the same method in Traditional Chinese Medicine .
-METHODS	In total , 168 patients with type 2 diabetes mellitus and vascular dementia were enrolled in the study , and randomly divided into two groups by simple randomization .
-METHODS	Patients in the treatment group received oral Sancaijiangtang powders with pioglitazone hydrochloride three times daily , while patients in the control group received pioglitazone hydrochloride alone .
-METHODS	The treatment course was for 12 weeks .
-METHODS	Mini-mental state examinations ( Chinese version ) and Montreal Cognitive Assessments ( Beijing version ) were performed , and fasting plasma glucose , fasting insulin , hemoglobin A1c , homeostasis model assessment of insulin resistance , plasma nitric oxide and endothelin-1 levels were measured before and after the treatment .
-RESULTS	The post-treatment levels for all measurements in both groups were better than pre-treat - ment levels ( P < 0.05 ) .
-RESULTS	The post-treatment levels for all measurements in the treatment group were better than the levels measured in the control group ( P < 0.05 ) .
-CONCLUSIONS	Type 2 diabetes mellitus and vascular dementia have common pathological mechanisms for insulin resistance and endothelium dysfunction .
-CONCLUSIONS	Sancaijiangtang powders could improve the release of nitric oxide and inhibit the secretion of endothelin-1 .
-CONCLUSIONS	Therefore , the material basis exists for treating the different diseases with the same method in Traditional Chinese Medicine .
-
-###24675241
-OBJECTIVE	The objectives of this prospective study were to compare the advantages of single-port laparoscopic cholecystectomy ( SPLC ) versus the classical four-port laparoscopic cholecystectomy ( CLC ) and to discuss these advantages in the light of current literature .
-METHODS	Forty eligible patients were randomized to receive SPLC ( Group A , N. = 20 ) and CLC ( Group B , N. = 20 ) , and investigated with regard to age , sex , BMI ( body mass index ) , ASA ( American Society of Anesthesiologists ) score , type of surgery , operative time , per-operative complication , indication for conversion to open surgery , indication for additional trocar placement in SPLC technique , post-operative pain score , additional narcotic analgesic requirement , nausea and vomiting , post-operative complication and length of hospital stay .
-METHODS	Visual analogue scale ( VAS ) was used for pain scoring in all cases .
-RESULTS	No significant difference was found among patients in Group A and Group B in terms of age , sex , weight/BMI , ASA score , VAS scores , additional analgesic requirement and length of hospital stay ( P > 0.05 ) .
-RESULTS	On the other hand , mean operative time in Group A was significantly ( P < 0.005 ) greater than that in Group B. Mean operative time in Group A was observed to be reduced after the first 10 operations .
-RESULTS	Conversion to open surgery was not required in any of the patients ; however , additional trocar placement was required in two patients in Group A due to body habitus and adhesions , and operations were completed laparoscopically .
-CONCLUSIONS	We conclude that SPLC is equally effective as CLC .
-CONCLUSIONS	Patient comfort is increased and pain is decreased as the surgeon gets experienced with the technique .
-
-###24560760
-BACKGROUND	The pediatric diffuse intrinsic pontine glioma ( DIPG ) outcome remains dismal despite multiple therapeutic attempts .
-OBJECTIVE	To compare the results of treatment of pediatric diffuse intrinsic pontine glioma ( DIPG ) using hypofractionated versus conventional radiotherapy .
-METHODS	Seventy-one newly diagnosed DIPG children were randomized into hypofractionated ( HF ) ( 39Gy/13 fractions in 2.6 weeks ) and conventional ( CF ) arm ( 54Gy/30 fractions in 6weeks ) .
-RESULTS	The median and one-year overall survival ( OS ) was 7.8 months and 36.48.2 % for the hypofractionated arm , and 9.5 and 26.27.4 % for the conventional arm respectively .
-RESULTS	The 18-month OS difference was 2.2 % .
-RESULTS	The OS hazard ratio ( HR ) was 1.14 ( 95 % CI : 0.70-1 .89 ) ( p = 0.59 ) .
-RESULTS	The hypofractionated arm had a median and one-year progression-free survival ( PFS ) of 6.6 months and 22.57.1 % , compared to 7.3 and 17.97.1 % for the conventional arm .
-RESULTS	The PFS HR was 1.10 ( 95 % CI : 0.67-1 .90 ) ( p = 0.71 ) .
-RESULTS	The 18-month PFS difference was 1.1 % .
-RESULTS	These differences exceed the non-inferiority margin .
-RESULTS	The immediate and delayed side effects were not different in the 2 arms .
-CONCLUSIONS	Hypofractionated radiotherapy offers lesser burden on the patients , their families and the treating departments , with nearly comparable results to conventional fractionation , though not fulfilling the non-inferiority assumption .
-
-###25582984
-OBJECTIVE	Pregnancy rates in US contraceptive clinical trials are increasing due to decreased treatment compliance .
-OBJECTIVE	This study compared compliance with a new low-dose levonorgestrel ( LNG ) and ethinyl estradiol ( EE ) contraceptive patch ( CP , Twirla ) with that of a low-dose combination oral contraceptive ( COC ) in a demographically diverse population .
-METHODS	This analysis was part of an open-label , parallel-group , multicenter phase 3 study that randomized healthy sexually active women ( 17-40years ) to 13cycles of LNG/EE CP or 6cycles of COC , then 7cycles of LNG/EE CP .
-METHODS	We defined self-reported compliance as cycles that , according to diaries , show 21days of patch wear without missed days or any patch worn > 7days or 21days of pill-taking without missed pill days .
-METHODS	We verified compliance by detectable plasma presence of LNG and EE at cycles 2 , 6 , and 13 .
-RESULTS	Of the intention-to-treat population with diary information ( N = 1328 , mean age 26.4 years , 46 % minorities , 33 % obese ) , 10.0 % of the CP ( n = 998 ) versus 21.2 % of the COC group ( n = 330 ) self-reported noncompliance after 6cycles ( p < .001 ) .
-RESULTS	Laboratory assessments verified 10-14 % of participants in both groups as noncompliant .
-RESULTS	Self-reported perfect use did not vary between obese [ body mass index ( BMI ) 30kg/m ( 2 ) ] versus nonobese ( BMI < 30kg/m ( 2 ) ) participants in both groups or when stratified by age , education , or race/ethnicity in the CP group .
-CONCLUSIONS	Self-reported compliance was significantly greater in the CP than COC group and did not vary by obesity status .
-CONCLUSIONS	Discrepancies between self-reported and verified compliance question reliability of patient diaries .
-CONCLUSIONS	This paper , based on an analysis of a phase 3 trial , shows that compliance was significantly greater with a new weekly transdermal CP than with a once-daily COC in obese as well as nonobese participants .
-CONCLUSIONS	Discrepancies between self-reported compliance and laboratory-verified compliance raise questions regarding the reliability of patient diaries .
-
-###25355940
-BACKGROUND	Pediatric respiratory infections caused by antibiotic-nonsusceptible Streptococcus pneumoniae ( ANSP ) continue to present an important challenge , even after introduction of 7-valent pneumococcal conjugate vaccine ( PCV7 ) .
-BACKGROUND	This randomized double-blind trial assessed the potential additional impact of PCV13 over PCV7 on reducing ANSP carriage .
-METHODS	Healthy infants were randomly assigned to receive PCV13 ( n = 932 ) or PCV7 ( n = 934 ) at ages 2 , 4 , 6 , or 12 months .
-METHODS	Eight nasopharyngeal specimens were collected by swabbing between ages 2 and 24 months .
-METHODS	S. pneumoniae isolates were serotyped and tested for antimicrobial susceptibility by the disk-diffusion method and the Etest .
-METHODS	Nasopharyngeal acquisition and prevalence of ANSP during ages 7-24 months were compared between the 2 vaccine groups .
-RESULTS	In general , new acquisition of pneumococci nonsusceptible to penicillin , erythromycin , clindamycin , penicillin plus erythromycin , and multiple drugs ( 3 antibiotics ) was significantly lower in the PCV13 group compared with the PCV7 group ; the main serotypes contributing to this significant decrease were serotype 19F , present in PCV13 and PCV7 , and serotypes 6A and 19A , present in PCV13 only .
-CONCLUSIONS	PCV13 has a significant added benefit over PCV7 in reducing carriage of ANSP .
-CONCLUSIONS	Because carriage determines transmission , these results suggest that PCV13 will provide protection against ANSP disease that exceeds protection provided by PCV7 .
-BACKGROUND	NCT00508742 .
-
-###24893602
-BACKGROUND	Homeless adults are more likely to smoke tobacco and are less likely to successfully quit smoking than smokers in the general population , despite comparable numbers of cessation attempts and desire to quit .
-BACKGROUND	To date , studies that have examined smoking cessation in homeless samples have used traditional lab/clinic-based assessment methodologies .
-BACKGROUND	Real-time assessment of key variables may provide new insights into the process of quitting among homeless smokers .
-METHODS	The purpose of the current study was to identify predictors of a quit attempt using real-time assessment methodology during the 6 days prior to a scheduled quit attempt among homeless adults seeking care at a shelter-based smoking cessation clinic .
-METHODS	Parameters for multiple variables ( i.e. , motivation for quitting , smoking expectancies , quit self-efficacy , smoking urges , negative affect , positive affect , restlessness , hostility , and stress ) were calculated and were used as predictors of biochemically verified quit date abstinence ( i.e. , 13hr abstinent ) using logistic regression analyses .
-RESULTS	Participants ( n = 57 ) were predominantly male ( 59.6 % ) , non-White ( 68.4 % ) , and smoked an average of 18 cigarettes per day .
-RESULTS	A total of 1,132 ecological momentary assessments ( 83 % completion rate ) were collected at random times ( i.e. , up to 4 assessments/day ) during the 6 days prior to a scheduled quit attempt .
-RESULTS	Results indicated that declining ( negative slope ) negative affect , restlessness , and stress predicted quit date abstinence .
-RESULTS	Additionally , increasing positive coping expectancies across the prequit week predicted quit date abstinence .
-CONCLUSIONS	Study findings highlight multiple variables that may be targeted during the precessation period to increase smoking cessation attempts in this difficult to treat population of smokers .
-
-###25231884
-OBJECTIVE	The goal of this research was to evaluate nutrition education targeting Latinas , a group at particular risk of obesity and diabetes , which predict to later life cardiovascular disease and dementia .
-METHODS	Culturally tailored , theory-based nutrition education was provided to Mexican origin Latinas aged 48 to 84 .
-METHODS	The randomized design compared participants in workshops incorporating the connection between dietary fat and brain health , participants in workshops focusing only on dietary fat and heart health , a waitlist control group , and a posttest only control group .
-RESULTS	Among those assigned to either intervention , there was statistically significant gain in health literacy , knowledge about dietary fat , and behaviors to reduce dietary fat compared with waitlist control .
-RESULTS	There was no difference in outcomes between those given the module about diet and brain health and those not provided that module .
-CONCLUSIONS	A program to encourage dietary fat modification in Latinas proved feasible and modestly effective .
-
-###24709780
-BACKGROUND	Umbilical cord milking ( UCM ) improves blood pressure and urine output , and decreases the need for transfusions in comparison to immediate cord clamping ( ICC ) .
-BACKGROUND	The immediate effect of UCM in the first few minutes of life and the impact on neonatal resuscitation has not been described .
-METHODS	Women admitted to a tertiary care center and delivering before 32 weeks gestation were randomized to receive UCM or ICC .
-METHODS	A blinded analysis of physiologic data collected on the newborns in the delivery room was performed using a data acquisition system .
-METHODS	Heart rate ( HR ) , SpO2 , mean airway pressure ( MAP ) , and FiO2 in the delivery room were compared between infants receiving UCM and infants with ICC .
-RESULTS	41 of 60 neonates who were enrolled and randomized had data from analog tracings at birth .
-RESULTS	20 of these infants received UCM and 21 had ICC .
-RESULTS	Infants receiving UCM had higher heart rates and higher SpO2 over the first 5 minutes of life , were exposed to less FiO2 over the first 10 minutes of life than infants with ICC .
-CONCLUSIONS	UCM when compared to ICC had decreased need for support immediately following delivery , and in situations where resuscitation interventions were needed immediately , UCM has the advantage of being completed in a very short time to improve stability following delivery .
-BACKGROUND	ClinicalTrials.gov NCT01434732 .
-
-###24723041
-OBJECTIVE	Dialectical Behavior Therapy has been initially designed and evaluated as an outpatient-treatment program for chronic suicidal female patients .
-OBJECTIVE	Within the last years , several adaptations of DBT for specific comorbidities , other settings or other disorders related to emotion dysregulation have been developed .
-OBJECTIVE	This report reviews conceptual aspects and the scientific evidence of initially designed Dialectical Behavior Therapy and the adaptations .
-METHODS	Systematic literature search and systematic review .
-RESULTS	Recently , two meta-analyses which are based on randomized controlled trials conclude robust and stabile effects of DBT Evidence from further RCTs and other studies show promise for the properties of many DBT adaptations .
-CONCLUSIONS	The current review of the literature suggests a good effectiveness of DBT , especially on complex disorders with deficits in the field of emotion regulation .
-
-###25374246
-BACKGROUND	Breast cancer ( BC ) is the most common cancer among females in Turkey .
-BACKGROUND	Predictors affecting the breast self-examination ( BSE ) performance vary in developing countries .
-OBJECTIVE	To determine the frequency of BSE performance and predictors of self-reported BSEs among women in the capital city of Turkey .
-METHODS	This cross-sectional study was conducted on 376 Turkish women using a self - administered questionnaire covering socio-demographic variables and BSE-related features .
-RESULTS	Of the participants , 78.7 % ( N = 296 ) reported practicing BSE , whereas 9.5 % ( N = 28 ) were implementing BSE regularly on a monthly basis , and only 5.7 % ( N = 17 ) were performing BSE regularly within a week after each menstrual cycle .
-RESULTS	Multivariate logistic regression modeling revealed that BSE performance was more likely in younger age groups [ 20-39 years ] ( p = 0.018 , OR = 3.215 ) and [ 40-49 years ] ( p = 0.009 , OR = 3.162 ) , women having a family history of breast disease ( p = 0.038 , OR = 2.028 ) , and housewives ( p = 0.013 , OR = 0.353 ) .
-CONCLUSIONS	Although it appears that the rates of BSE performers are high , the number of women conducting appropriate BSE on a regular time interval basis is lower than expected .
-CONCLUSIONS	Younger age groups , family history of breast diseases and not being employed were identified as significant predictors of practicing BSE appropriately .
-CONCLUSIONS	Older age and employment were risk factors for not performing BSE in this sample .
-
-###24286801
-OBJECTIVE	To analyze the results of the use of intra-articular cultured autologous bone marrow-derived mesenchymal stem cell ( MSC ) injections in conjunction with microfracture and medial opening-wedge high tibial osteotomy ( HTO ) .
-METHODS	Fifty-six knees in 56 patients with unicompartmental osteoarthritic knees and genu varum were randomly allocated to the cell-recipient group ( n = 28 ) or control group ( n = 28 ) .
-METHODS	Patients who had a joint line congruity angle of more than 2 , malalignment of the knee from femoral causes , a fixed flexion deformity , or age older than 55 years were excluded .
-METHODS	All patients underwent HTO and microfracture .
-METHODS	The cell-recipient group received intra-articular injection of cultured MSCs with hyaluronic acid 3 weeks after surgery , whereas the control group only received hyaluronic acid .
-METHODS	The primary outcome measure was the International Knee Documentation Committee ( IKDC ) score at intervals of 6 months , 1 year , and 2 years postoperatively .
-METHODS	Secondary outcome measures were Tegner and Lysholm clinical scores and 1-year postoperative Magnetic Resonance Observation of Cartilage Repair Tissue ( MOCART ) scores .
-RESULTS	The median age of the patients was 51 years , with a mean body mass index of 23.85 .
-RESULTS	Both treatment arms achieved improvements in Tegner , Lysholm , and IKDC scores .
-RESULTS	After adjustment for age , baseline scores , and time of evaluation , the cell-recipient group showed significantly better scores .
-RESULTS	The effect of treatment showed an added improvement of 7.65 ( 95 % confidence interval [ CI ] , 3.04 to 12.26 ; P = .001 ) for IKDC scores , 7.61 ( 95 % CI , 1.44 to 13.79 ; P = .016 ) for Lysholm scores , and 0.64 ( 95 % CI , 0.10 to 1.19 ; P = .021 ) for Tegner scores .
-RESULTS	Magnetic resonance imaging scans performed 1 year after surgical intervention showed significantly better MOCART scores for the cell-recipient group .
-RESULTS	The age-adjusted mean difference in MOCART score was 19.6 ( 95 % CI , 10.5 to 28.6 ; P < .001 ) .
-CONCLUSIONS	Intra-articular injection of cultured MSCs is effective in improving both short-term clinical and MOCART outcomes in patients undergoing HTO and microfracture for varus knees with cartilage defects .
-METHODS	Level II , randomized controlled trial .
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-###25187119
-CONCLUSIONS	This prospective study showed that the incidence of acute anterior uveitis , confirmed by ophthalmic examination , in patients receiving intravenous zoledronate infusions as part of a randomized controlled trial for fracture prevention is 1.1 % .
-BACKGROUND	We prospectively investigated the incidence of ocular side effects after a single intravenous zoledronate infusion .
-METHODS	In a secondary analysis of a double-blind , placebo-controlled trial in which early post-menopausal women ( N = 1054 ) with normal bone density or osteopenia were randomized to infusion of zoledronate 5 mg ( N = 703 ) or placebo ( N = 351 ) , we analyzed significant adverse ocular events occurring within 3 months .
-RESULTS	Fourteen participants reported ocular symptoms after the infusion .
-RESULTS	All were examined by an ophthalmologist and eight were diagnosed with acute anterior uveitis ( AAU ) and one with sectoral episcleritis .
-RESULTS	The incidence of AAU and episcleritis was 1.1 % ( 95 % CI 0.5-2 .1 ) and 0.1 % ( 95 % CI 0.0-0 .7 ) , respectively , in the zoledronate group and 0 % for both conditions in the placebo group ( 95 % CI 0.0-0 .8 ) .
-RESULTS	The mean time from infusion to symptom onset for AAU was 3 days ( range 2-4 ) .
-RESULTS	Three cases were bilateral .
-RESULTS	AAU was mild-moderate in seven participants and severe in one .
-RESULTS	All affected eyes were treated with topical cyclopentolate 1 % ( to break , or minimize , posterior synechiae ) , and intensive , potent , topical corticosteroids with a tapering regime based on treatment response .
-RESULTS	The mean duration of topical corticosteroid was 2610 days ( range 17-44 ) .
-RESULTS	The mean , best corrected visual acuity was 20/20 ( range 20/20-20 / 40 ) at presentation , which remained unchanged after AAU resolution .
-RESULTS	None of the participants lost vision , and no long-term sequelae were reported at last follow-up ( range 3-13 months post-infusion ) .
-CONCLUSIONS	Prescribers should inform patients about the possibility of ocular side effects with zoledronate infusions and refer promptly to an ophthalmologist if symptoms develop .
-
-###25301881
-OBJECTIVE	To evaluate the outcomes of standard automated perimetry ( SAP ) in patients with obstructive sleep apnea ( OSA ) .
-METHODS	Eighty OSA patients and 111 age-matched controls were consecutively and prospectively enrolled .
-METHODS	One eye per subject was randomly selected .
-METHODS	All participants underwent at least one reliable SAP ( 24-2 SITA Standard algorithm ) .
-METHODS	The peripapillary retinal nerve fiber layer thickness ( RNFL ) was measured with spectral-domain optical coherence tomography ( OCT ) .
-METHODS	Patients with OSA were classified into three groups according to the apnea/hypopnea index : mild , moderate , or severe OSA .
-METHODS	Parameters of SAP and OCT were compared between healthy controls and OSA patients .
-METHODS	Correlation of apnea/hypopnea index with OCT and SAP measurements were calculated .
-RESULTS	Mean age , best-corrected visual acuity , and central corneal thickness were similar between groups .
-RESULTS	Intraocular pressure , however , was lower in the OSA group .
-RESULTS	Mean deviation of SAP was -0.23 0.8 dB in the control group and -1.74 2.8 dB in the OSA group ( P < 0.001 ) .
-RESULTS	Thickness of RNFL measured with OCT did not differ significantly between groups .
-RESULTS	Patients with OSA showed reduced sensitivity at most points tested by white-on-white perimetry compared with healthy individuals .
-RESULTS	The threshold values were more depressed in the peripheral visual field .
-RESULTS	The apnea/hypopnea index was related to the SAP indices : Pearson correlations were -0.432 with mean deviation , 0.467 with pattern standard deviation , and -0.416 with the visual field index ( P < 0.001 ) .
-CONCLUSIONS	Patients with OSA exhibited reduced retinal sensitivity measured with SAP compared with healthy controls .
-
-###25337750
-BACKGROUND	A fluoropyrimidine plus irinotecan or oxaliplatin , combined with bevacizumab ( a monoclonal antibody against vascular endothelial growth factor ) , is standard first-line treatment for metastatic colorectal cancer .
-BACKGROUND	Before the introduction of bevacizumab , chemotherapy with fluorouracil , leucovorin , oxaliplatin , and irinotecan ( FOLFOXIRI ) showed superior efficacy as compared with fluorouracil , leucovorin , and irinotecan ( FOLFIRI ) .
-BACKGROUND	In a phase 2 study , FOLFOXIRI plus bevacizumab showed promising activity and an acceptable rate of adverse effects .
-METHODS	We randomly assigned 508 patients with untreated metastatic colorectal cancer to receive either FOLFIRI plus bevacizumab ( control group ) or FOLFOXIRI plus bevacizumab ( experimental group ) .
-METHODS	Up to 12 cycles of treatment were administered , followed by fluorouracil plus bevacizumab until disease progression .
-METHODS	The primary end point was progression-free survival .
-RESULTS	The median progression-free survival was 12.1 months in the experimental group , as compared with 9.7 months in the control group ( hazard ratio for progression , 0.75 ; 95 % confidence interval [ CI ] , 0.62 to 0.90 ; P = 0.003 ) .
-RESULTS	The objective response rate was 65 % in the experimental group and 53 % in the control group ( P = 0.006 ) .
-RESULTS	Overall survival was longer , but not significantly so , in the experimental group ( 31.0 vs. 25.8 months ; hazard ratio for death , 0.79 ; 95 % CI , 0.63 to 1.00 ; P = 0.054 ) .
-RESULTS	The incidences of grade 3 or 4 neurotoxicity , stomatitis , diarrhea , and neutropenia were significantly higher in the experimental group .
-CONCLUSIONS	FOLFOXIRI plus bevacizumab , as compared with FOLFIRI plus bevacizumab , improved the outcome in patients with metastatic colorectal cancer and increased the incidence of some adverse events .
-CONCLUSIONS	( Funded by the Gruppo Oncologico Nord Ovest and others ; ClinicalTrials.gov number , NCT00719797 . )
-
-###24613160
-OBJECTIVE	To determine whether graft patency after on-pump and off-pump coronary artery bypass surgery is similar when performed using the same heparinization protocol .
-METHODS	In a randomized , controlled , multicenter trial , 900 patients more than 70 years of age received either on-pump or off-pump coronary artery bypass surgery .
-METHODS	Heparin was given to achieve an activated clotting time of 400 seconds before arteriotomy in both groups .
-METHODS	After the procedure , protamine sulfate was given to revert the activated clotting time to less than 120 seconds .
-METHODS	Coronary angiography was performed 6 months after the operation and graft patency was assessed by independent blinded observers .
-RESULTS	A total of 481 patients underwent angiography .
-RESULTS	In the off-pump group , 561 ( 79 % ) of 710 grafts were open , 65 ( 9 % ) were stenotic , and 84 ( 12 % ) were occluded .
-RESULTS	In the on-pump group , 549 ( 86 % ) of 650 grafts were open , 38 ( 5 % ) were stenotic , and 63 ( 9 % ) were occluded .
-RESULTS	The difference between the proportion of open grafts was statistically significant in favor of on-pump surgery ( P = .01 ) .
-RESULTS	The proportion of open left internal thoracic artery grafts was 95 % in both groups .
-RESULTS	Perioperative use of intracoronary shunts did not increase the risk of stenosis of the coronary artery distal to the anastomosis .
-CONCLUSIONS	Despite comparable heparinization , graft patency after off-pump surgery was inferior to that after on-pump surgery .
-
-###26121788
-BACKGROUND	The recommended intake of clear liquids until 2 hours before surgery is reportedly safe and effective .
-BACKGROUND	We investigated whether oral rehydration therapy before surgery had improved satisfaction , stress response , and hemodynamics in patients during perioperative period .
-METHODS	Patients scheduled to undergo laparoscopic colectomy were enrolled and randomly divided into 2 groups .
-METHODS	The oral rehydration therapy ( ORT ) group ( 29 cases ) was allowed to drink clear liquids until 2 hours before anesthesia induction and the control group ( 29 cases ) fasted from 21 : 00 the night before surgery .
-METHODS	All patients entered the operating room at 8 : 40 .
-METHODS	Patient satisfaction was examined after admission to the operating room .
-METHODS	The volume and pH of gastric fluid were measured after anesthetic induction .
-METHODS	The serum concentrations of cortisol and catecholamine were measured as stress response indicators after anesthetic induction and at the completion of surgery .
-METHODS	Intraoperative hemodynamics was also recorded .
-RESULTS	There were no differences in patient satisfaction , stress response , and hemodynamics between the 2 groups .
-RESULTS	Intraoperative urine volume was significantly larger in the ORT group .
-RESULTS	Vomiting and aspiration were not observed in any patient
-CONCLUSIONS	Oral rehydration therapy until 2 hours before surgery seemed safe but did not improve satisfaction , stress response , and hemodynamics in perioperative patients .
-
-###25278093
-BACKGROUND	Residual proteinuria during renin-angiotensin-aldosterone system ( RAAS ) blockade is a major renal and cardiovascular risk factor in chronic kidney disease .
-BACKGROUND	Dietary sodium restriction potentiates the antiproteinuric effect of RAAS blockade , but residual proteinuria remains in many patients .
-BACKGROUND	Previous studies linked high fibroblast growth factor 23 ( FGF-23 ) levels with volume overload ; others linked higher serum phosphate levels with impaired RAAS-blockade efficacy .
-BACKGROUND	We hypothesized that FGF-23 reduces the capacity of dietary sodium restriction to potentiate RAAS blockade , impairing the antiproteinuric effect .
-METHODS	Post hoc analysis of cohort data from a randomized crossover trial with two 6-week study periods comparing proteinuria after a regular-sodium diet with proteinuria after a low-sodium diet , both during background angiotensin-converting enzyme inhibition .
-METHODS	47 nondiabetic patients with CKD with residual proteinuria ( median protein excretion , 1.9 [ IQR , 0.8-3 .1 ] g/d ; mean age , 5013 [ SD ] years ; creatinine clearance , 69 [ IQR , 50-110 ] mL/min ) .
-METHODS	Plasma carboxy-terminal FGF-23 levels .
-RESULTS	Difference in residual proteinuria at the end of the regular-sodium versus low-sodium study period .
-RESULTS	Residual proteinuria during the low-sodium diet period adjusted for proteinuria during the regular-sodium diet period .
-RESULTS	Higher baseline FGF-23 level was associated with reduced antiproteinuric response to dietary sodium restriction ( standardized = -0.46 ; P = 0.001 ; model R ( 2 ) = 0.71 ) .
-RESULTS	For every 100-RU/mL increase in FGF-23 level , the antiproteinuric response to dietary sodium restriction was reduced by 10.6 % .
-RESULTS	Higher baseline FGF-23 level was a determinant of more residual proteinuria during the low-sodium diet ( standardized = 0.27 ; P = 0.003 ) in linear regression analysis adjusted for baseline proteinuria ( model R ( 2 ) = 0.71 ) .
-RESULTS	There was no interaction with creatinine clearance ( P interaction = 0.5 ) .
-RESULTS	Baseline FGF-23 level did not predict changes in systolic or diastolic blood pressure upon intensified antiproteinuric treatment .
-CONCLUSIONS	Observational study , limited sample size .
-CONCLUSIONS	FGF-23 levels are associated independently with impaired antiproteinuric response to sodium restriction in addition to RAAS blockade .
-CONCLUSIONS	Future studies should address whether FGF-23-lowering strategies may further optimize proteinuria reduction by RAAS blockade combined with dietary sodium restriction .
-
-###26284719
-OBJECTIVE	Low-molecular-weight heparin is recommended over warfarin for the treatment of acute venous thromboembolism ( VTE ) in patients with active cancer largely based on results of a single , large trial .
-OBJECTIVE	To study the efficacy and safety of tinzaparin vs warfarin for treatment of acute , symptomatic VTE in patients with active cancer .
-METHODS	A randomized , open-label study with blinded central adjudication of study outcomes enrolled patients in 164 centers in Asia , Africa , Europe , and North , Central , and South America between August 2010 and November 2013 .
-METHODS	Adult patients with active cancer ( defined as histologic diagnosis of cancer and receiving anticancer therapy or diagnosed with , or received such therapy , within the previous 6 months ) and objectively documented proximal deep vein thrombosis ( DVT ) or pulmonary embolism , with a life expectancy greater than 6 months and without contraindications for anticoagulation , were followed up for 180 days and for 30 days after the last study medication dose for collection of safety data .
-METHODS	Tinzaparin ( 175 IU/kg ) once daily for 6 months vs conventional therapy with tinzaparin ( 175 IU/kg ) once daily for 5 to 10 days followed by warfarin at a dose adjusted to maintain the international normalized ratio within the therapeutic range ( 2.0-3 .0 ) for 6 months .
-METHODS	Primary efficacy outcome was a composite of centrally adjudicated recurrent DVT , fatal or nonfatal pulmonary embolism , and incidental VTE .
-METHODS	Safety outcomes included major bleeding , clinically relevant nonmajor bleeding , and overall mortality .
-RESULTS	Nine hundred patients were randomized and included in intention-to-treat efficacy and safety analyses .
-RESULTS	Recurrent VTE occurred in 31 of 449 patients treated with tinzaparin and 45 of 451 patients treated with warfarin ( 6-month cumulative incidence , 7.2 % for tinzaparin vs 10.5 % for warfarin ; hazard ratio [ HR ] , 0.65 [ 95 % CI , 0.41-1 .03 ] ; P = .07 ) .
-RESULTS	There were no differences in major bleeding ( 12 patients for tinzaparin vs 11 patients for warfarin ; HR , 0.89 [ 95 % CI , 0.40-1 .99 ] ; P = .77 ) or overall mortality ( 150 patients for tinzaparin vs 138 patients for warfarin ; HR , 1.08 [ 95 % CI , 0.85-1 .36 ] ; P = .54 ) .
-RESULTS	A significant reduction in clinically relevant nonmajor bleeding was observed with tinzaparin ( 49 of 449 patients for tinzaparin vs 69 of 451 patients for warfarin ; HR , 0.58 [ 95 % CI , 0.40-0 .84 ] ; P = .004 ) .
-CONCLUSIONS	Among patients with active cancer and acute symptomatic VTE , the use of full-dose tinzaparin ( 175 IU/kg ) daily compared with warfarin for 6 months did not significantly reduce the composite measure of recurrent VTE and was not associated with reductions in overall mortality or major bleeding , but was associated with a lower rate of clinically relevant nonmajor bleeding .
-CONCLUSIONS	Further studies are needed to assess whether the efficacy outcomes would be different in patients at higher risk of recurrent VTE .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01130025 .
-
-###24567515
-BACKGROUND	The role of body mass index ( BMI ) in survival outcomes is controversial among lymphoma patients .
-BACKGROUND	We evaluated the association between BMI at study entry and failure-free survival ( FFS ) and overall survival ( OS ) in three phase III clinical trials , among patients with diffuse large B-cell lymphoma ( DLBCL ) , follicular lymphoma ( FL ) and Hodgkin 's lymphoma ( HL ) .
-METHODS	A total of 537 , 730 and 282 patients with DLBCL , HL and FL were included in the analysis .
-METHODS	Baseline patient and clinical characteristics , treatment received and clinical outcomes were compared across BMI categories .
-RESULTS	Among patients with DLBCL , HL and FL , the median age was 70 , 33 and 56 ; 29 % , 29 % and 37 % were obese and 38 % , 27 % and 37 % were overweight , respectively .
-RESULTS	Age was significantly different among BMI groups in all three studies .
-RESULTS	Higher BMI groups tended to have more favorable prognosis factors at study entry among DLBCL and HL patients .
-RESULTS	BMI was not associated with clinical outcome with P-values of 0.89 , 0.30 and 0.40 for FFS , and 0.64 , 0.67 and 0.09 for OS , for patients with DLBCL , HL and FL , respectively .
-RESULTS	The association remains non-significant after adjusting for other clinical factors in the Cox model .
-RESULTS	A subset analysis of males with DLBCL treated on R-CHOP revealed no differences in FFS ( P = 0.48 ) or OS ( P = 0.58 ) .
-CONCLUSIONS	BMI was not significantly associated with clinical outcomes among patients with DLBCL , HD or FL , in three prospective phase III clinical trials .
-CONCLUSIONS	The findings contradict some previous reports of similar investigations .
-CONCLUSIONS	Further work is required to understand the observed discrepancies .
-
-###24853275
-OBJECTIVE	Although transcatheter arterial chemoembolization ( TACE ) is the most common treatment option in patients with hepatocellular carcinoma ( HCC ) , its clinical benefits remain still controversial .
-OBJECTIVE	Since TACE induces hypoxic necrosis in tumors , hypoxia-inducible factor 1 ( HIF-1 ) could critically affect biology in residual tumors after TACE treatment and subsequent prognosis .
-OBJECTIVE	However , HIF-1 and its prognostic relevance in TACE have rarely been examined in human specimens .
-OBJECTIVE	In the current study , we investigated the prognosis and expression of genes regulated by HIF-1 in HCC patients receiving preoperative TACE for the first time .
-METHODS	In total , 35 patients with HCC ( 10 patients undergoing preoperative TACE ) were retrospectively studied .
-METHODS	The prognostic significance of TACE was analyzed using Kaplan-Meier and Cox regression models .
-METHODS	Protein levels of HIF-1 and mRNA levels of HIF-1-associated genes were examined using immunohistochemistry ( IHC ) and real-time RT-PCR , respectively .
-RESULTS	Preoperative TACE was significantly associated with increased 2-year recurrence rate ( 80 vs. 36 % , P = 0.00402 ) and shorter disease-free survival ( DFS ) time ( 11.9 vs. 35.7 months , P = 0.0182 ) .
-RESULTS	TACE was an independent prognostic factor for recurrence ( P = 0.007 ) and poor DFS ( P = 0.010 ) in a multivariate analysis .
-RESULTS	Immunohistochemical staining revealed in vivo activation of HIF-1 in human specimens treated with TACE .
-RESULTS	Notably , protein levels of HIF-1 were significantly increased in TACE tissues demonstrated by IHC .
-RESULTS	Transcriptional targets of HIF-1 showed mRNA expression patterns consistent with activation of HIF-1 in TACE tissues .
-CONCLUSIONS	Our findings collectively demonstrate that preoperative TACE confers poor prognosis in HCC patients through activation of HIF-1 .
-
-###25190728
-BACKGROUND	There are conflicting reports on the impact of soy on breast carcinogenesis .
-BACKGROUND	This study examines the effects of soy supplementation on breast cancer-related genes and pathways .
-METHODS	Women ( n = 140 ) with early-stage breast cancer were randomly assigned to soy protein supplementation ( n = 70 ) or placebo ( n = 70 ) for 7 to 30 days , from diagnosis until surgery .
-METHODS	Adherence was determined by plasma isoflavones : genistein and daidzein .
-METHODS	Gene expression changes were evaluated by NanoString in pre - and posttreatment tumor tissue .
-METHODS	Genome-wide expression analysis was performed on posttreatment tissue .
-METHODS	Proliferation ( Ki67 ) and apoptosis ( Cas3 ) were assessed by immunohistochemistry .
-RESULTS	Plasma isoflavones rose in the soy group ( two-sided Wilcoxon rank-sum test , P < .001 ) and did not change in the placebo group .
-RESULTS	In paired analysis of pre - and posttreatment samples , 21 genes ( out of 202 ) showed altered expression ( two-sided Student 's t-test , P < .05 ) .
-RESULTS	Several genes including FANCC and UGT2A1 revealed different magnitude and direction of expression changes between the two groups ( two-sided Student 's t-test , P < .05 ) .
-RESULTS	A high-genistein signature consisting of 126 differentially expressed genes was identified from microarray analysis of tumors .
-RESULTS	This signature was characterized by overexpression ( > 2-fold ) of cell cycle transcripts , including those that promote cell proliferation , such as FGFR2 , E2F5 , BUB1 , CCNB2 , MYBL2 , CDK1 , and CDC20 ( P < .01 ) .
-RESULTS	Soy intake did not result in statistically significant changes in Ki67 or Cas3 .
-CONCLUSIONS	Gene expression associated with soy intake and high plasma genistein defines a signature characterized by overexpression of FGFR2 and genes that drive cell cycle and proliferation pathways .
-CONCLUSIONS	These findings raise the concerns that in a subset of women soy could adversely affect gene expression in breast cancer .
-
-###24290594
-OBJECTIVE	The aim of this study was to examine the effect of yeast hydrolysate on the abdominal fat in obese humans .
-METHODS	We observed the effects of yeast hydrolysate that had a molecular weight below 10 kDa on the anti-abdominal fat accumulation in obese men and women ages 20 to 50 y for 10 wk .
-METHODS	The abdominal fat mass was assessed by computed tomographic scans .
-RESULTS	By the sixth week , the reductions in energy intake in the yeast group ( yeast hydrolysate 1 g/d ) were significantly greater than those in the control group ( placebo 1 g/d ) ( P < 0.05 ) .
-RESULTS	The body weight and body mass index ( BMI ) were significantly reduced by week 10 compared with baseline in the yeast group , and these differences were significantly greater than those in the control group : body weight 0.83 kg versus -2.60 k g ( P < 0.001 ) , BMI 0.29 kg/m ( 2 ) versus -0.90 kg/m ( 2 ) ( P < 0.001 ) .
-RESULTS	Despite the increased loss of body weight in the yeast group , lean body mass did not significantly differ between the two groups .
-RESULTS	Body fat mass in the control group did not significantly change between baseline and week 10 .
-RESULTS	However , the yeast group lost a significant amount of body fat mass after 10 wk of treatment ( P < 0.01 ) .
-RESULTS	The differences in abdominal fat thickness and abdominal circumference between the two groups were significant after 10 wk of treatment ( P < 0.001 ) .
-RESULTS	The total abdominal fat area in the yeast group was significantly lower than in the control group after 10 wk of treatment ( -7.06 cm ( 2 ) versus -17.34 cm ( 2 ) ; P < 0.01 ) .
-CONCLUSIONS	Yeast hydrolysate can reduce body weight and the accumulation of abdominal fat without an adverse effect on lean body mass in obese adults , regardless of sex , via the reduction of energy intake .
-
-###24261644
-BACKGROUND	Delirium is a frequent disorder in intensive care unit ( ICU ) patients with serious consequences .
-BACKGROUND	Therefore , preventive treatment for delirium may be beneficial .
-BACKGROUND	Worldwide , haloperidol is the first choice for pharmacological treatment of delirious patients .
-BACKGROUND	In daily clinical practice , a lower dose is sometimes used as prophylaxis .
-BACKGROUND	Some studies have shown the beneficial effects of prophylactic haloperidol on delirium incidence as well as on mortality , but evidence for effectiveness in ICU patients is limited .
-BACKGROUND	The primary objective of our study is to determine the effect of haloperidol prophylaxis on 28-day survival .
-BACKGROUND	Secondary objectives include the incidence of delirium and delirium-related outcome and the side effects of haloperidol prophylaxis .
-METHODS	This will be a multicenter three-armed randomized , double-blind , placebo-controlled , prophylactic intervention study in critically ill patients .
-METHODS	We will include consecutive non-neurological ICU patients , aged 18 years with an expected ICU length of stay > 1 day .
-METHODS	To be able to demonstrate a 15 % increase in 28-day survival time with a power of 80 % and alpha of 0.05 in both intervention groups , a total of 2,145 patients will be randomized ; 715 in each group .
-METHODS	The anticipated mortality rate in the placebo group is 12 % .
-METHODS	The intervention groups will receive prophylactic treatment with intravenous haloperidol 1 mg/q8h or 2 mg/q8h , and patients in the control group will receive placebo ( sodium chloride 0.9 % ) , both for a maximum period of 28-days .
-METHODS	In patients who develop delirium , study medication will be stopped and patients will subsequently receive open label treatment with a higher ( therapeutic ) dose of haloperidol .
-METHODS	We will use descriptive summary statistics as well as Cox proportional hazard regression analyses , adjusted for covariates .
-CONCLUSIONS	This will be the first large-scale multicenter randomized controlled prevention study with haloperidol in ICU patients with a high risk of delirium , adequately powered to demonstrate an effect on 28-day survival .
-BACKGROUND	Clinicaltrials.gov : NCT01785290.EudraCT number : 2012-004012-66 .
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-###25373630
-BACKGROUND	Intranasal ( IN ) insulin acutely improves verbal memory in mild cognitive impairment ( MCI ) / Alzheimer 's disease ( AD ) , but its therapeutic effects may be attenuated in apolipoprotein E4 ( ApoE4 ) carriers .
-BACKGROUND	Furthermore , rapid-acting ( RA ) insulins may have superior therapeutic effects compared with regular insulin types .
-OBJECTIVE	To measure the safety and efficacy of intranasally delivered RA glulisine in ApoE4 carriers with mild-moderate AD .
-METHODS	We performed a double-blinded , randomized , cross-over study of RA insulin glulisine in nine mild-moderate AD subjects to better understand the relationship between RA insulin , ApoE4 carrier status and memory performance .
-RESULTS	IN glulisine was well tolerated but failed to have an acute impact on cognition in ApoE4 carriers with AD .
-RESULTS	Serum insulin levels acutely dropped following treatment , but peripheral glucose levels remained unchanged .
-CONCLUSIONS	Larger clinical trials of longer duration are necessary to better understand the relationships between RA insulin , ApoE4 carrier status and cognitive performance in AD .
-
-###25344693
-BACKGROUND	Health-promoting lifestyle choices of adolescents are closely related to current and subsequent health status .
-BACKGROUND	However , parsimonious yet reliable and valid screening tools are scarce .
-BACKGROUND	The original 40-item adolescent health promotion ( AHP ) scale was developed by our research team and has been applied to measure adolescent health-promoting behaviors worldwide .
-BACKGROUND	The aim of our study was to examine the psychometric properties of a newly developed short-form version of the AHP ( AHP-SF ) including tests of its reliability and validity .
-METHODS	The study was conducted in nine middle and high schools in southern Taiwan .
-METHODS	Participants were 814 adolescents randomly divided into two subgroups with equal size and homogeneity of baseline characteristics .
-METHODS	The first subsample ( calibration sample ) was used to modify and shorten the factorial model while the second subsample ( validation sample ) was utilized to validate the result obtained from the first one .
-METHODS	The psychometric testing of the AHP-SF included internal reliability of McDonald 's omega and Cronbach 's alpha , convergent validity , discriminant validity , and construct validity with confirmatory factor analysis ( CFA ) .
-RESULTS	The results of the CFA supported a six-factor model and 21 items were retained in the AHP-SF with acceptable model fit .
-RESULTS	For the discriminant validity test , results indicated that adolescents with lower AHP-SF scores were more likely to be overweight or obese , skip breakfast , and spend more time watching TV and playing computer games .
-RESULTS	The AHP-SF also showed excellent internal consistency with a McDonald 's omega of 0.904 ( Cronbach 's alpha 0.905 ) in the calibration group .
-CONCLUSIONS	The current findings suggest that the AHP-SF is a valid and reliable instrument for the evaluation of adolescent health-promoting behaviors .
-CONCLUSIONS	Primary health care providers and clinicians can use the AHP-SF to assess these behaviors and evaluate the outcome of health promotion programs in the adolescent population .
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-###25602877
-OBJECTIVE	We ( 1 ) evaluated the impact of an evidence-based HIV prevention program with and without a parent component among mid-adolescents living in the Caribbean and ( 2 ) determined the effect of prior receipt of a related intervention during preadolescence on intervention response .
-METHODS	A randomized , controlled 4-cell trial of a 10-session , theory-based HIV prevention intervention involving 2564 Bahamian grade-10 youths ( some of whom had received a comparable intervention in grade 6 ) was conducted ( 2008-2011 ) .
-METHODS	Randomization occurred at the level of the classroom with follow-up at 6 , 12 , and 18 months after intervention .
-METHODS	The 3 experimental conditions all included the youths ' curriculum and either a youth-parent intervention emphasizing adolescent-parent communication , a parent-only goal-setting intervention , or no parent intervention .
-RESULTS	An intervention delivered to mid-adolescents in combination with a parent-adolescent sexual-risk communication intervention increased HIV/AIDS knowledge , condom-use skills , and self-efficacy and had a marginal effect on consistent condom use .
-RESULTS	Regardless of prior exposure to a similar intervention as preadolescents , youths benefited from receipt of the intervention .
-CONCLUSIONS	Preadolescents and mid-adolescents in HIV-affected countries should receive HIV prevention interventions that include parental participation .
-
-###25175762
-BACKGROUND	Childhood cancer survivors have an increased risk of developing cardiovascular disease following treatment , yet few interventions have been evaluated to reduce this risk .
-BACKGROUND	Purple grape juice ( pGJ ) , a rich source of flavonoids with antioxidant properties , has been shown in adults to reduce oxidative stress and improve endothelial function .
-BACKGROUND	We examined the effects of supplementing meals with pGJ on microvascular endothelial function and markers of oxidative stress and inflammation in 24 cancer survivors ( ages 10-21 years ) .
-METHODS	In a randomized controlled crossover trial consisting of two , 4 week intervention periods , each preceded by a 4 week washout period , subjects received in random order 6 ounces twice daily of pGJ and clear apple juice ( cAJ ; similar in calories but lower in flavonoids ) .
-METHODS	Measurements were obtained before and after each supplementation period ; change was evaluated using mixed effects ANOVA .
-RESULTS	pGJ did not improve endothelial function , measured using digital reactive hyperemia , compared with cAJ ( mean change : pGJ 0.06 , cAJ 0.22 ; difference of mean change [ 95 % CI ] : -0.16 [ -0.42 - 0.11 ] , P = 0.25 ) .
-RESULTS	No significant changes in plasma concentrations of oxidized-LDL , myeloperoxidase , or high sensitivity C-reactive protein were observed .
-CONCLUSIONS	After 4 weeks of daily consumption of flavonoid-rich pGJ , no measurable change in vascular function was observed in these childhood cancer survivors .
-
-###25499753
-BACKGROUND	The development of secondary non-response ( SNR ) to botulinum neurotoxin type-A ( BoNT-A ) is considered a key issue in the management of cervical dystonia ( CD ) .
-BACKGROUND	This case-controlled study was performed to systematically identify factors influencing SNR during BoNT-A therapy .
-METHODS	This was a retrospective , international , non-interventional study of CD patients .
-METHODS	Patients with SNR were matched with up to three responder patients ( control ) on the basis of duration of therapy and number of injection cycles .
-METHODS	Factors influencing the development of SNR were screened using a univariate logistic regression model and confirmed using a multivariate conditional logistic regression model .
-RESULTS	216 patients were enrolled , and 201 ( SNR = 52 ; responder = 149 ) were matched and subdivided into blocks ( doublets , triplets or quadruplets ) .
-RESULTS	At baseline , a significantly higher proportion of SNR patients had received previous or concomitant therapies ( p = 0.038 ) and surgery for CD ( p = 0.007 ) compared with controls .
-RESULTS	Although disease severity at onset was similar between groups , a significantly higher proportion of SNR patients experienced severe CD at the time of SNR compared with controls at the last documented visit .
-RESULTS	Multivariate analyses identified five factors that were significantly associated in predicting SNR ( odds ratio [ OR ] > 1 indicated higher chances for being SNR ) : previous surgical procedure for CD ( OR 9.8 , p = 0.013 ) , previous BoNT-A related severe adverse event ( AE ) ( OR 5.6 p = 0.027 ) , physical therapy ( OR 4.6 , p = 0.028 ) , neuroleptic use ( OR 3.3 , p = 0.019 ) and average BoNT-A dose ( OR 2.7 , p = 0.010 ) .
-CONCLUSIONS	These findings suggest that SNR may not reflect true pharmacological resistance to BoNT-A therapy , but may be related to underlying disease severity .
-
-###24908241
-BACKGROUND	Acupuncture has been widely used as a treatment for stroke in China for more than 3,000 years .
-BACKGROUND	However , previous research has not yet shown that acupuncture is effective as a stroke treatment .
-BACKGROUND	We report a protocol for a multicenter , randomized , controlled , and outcome assessor-blind trial to evaluate the efficacy and safety of acupuncture on acute ischemic stroke .
-METHODS	In a prospective trial involving three hospitals in the Zhejiang Province ( China ) 250 patients with a recent ( less than 1 week previous ) episode of ischemic stroke will be included .
-METHODS	Patients will be randomized into two groups : an acupuncture group given scalp acupuncture and electroacupuncture , and a control group given no acupuncture .
-METHODS	Eighteen treatment sessions will be performed over a three-week period .
-METHODS	The primary outcome will be measured by changes in the National Institutes of Health Stroke Scale score at the one , three , and four-week follow-up .
-METHODS	Secondary outcome measures will be : 1 ) the Fugl-Meyer assessment scale for motor function ; 2 ) the mini-mental state examination and Montreal cognitive assessment for cognitive function ; 3 ) the video-fluoroscopic swallowing study for swallowing ability ; and 4 ) the incidence of adverse events .
-CONCLUSIONS	This trial is expected to clarify whether or not acupuncture is effective for acute stroke .
-CONCLUSIONS	It will also show if acupuncture can improve motor , cognitive , or swallowing function .
-BACKGROUND	Chinese Clinical Trial Registry ChiCTR-TRC-12001971 .
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-###24340290
-OBJECTIVE	The extant literature on predictors of treatment response to behavioral treatments for insomnia is equivocal and limited in scope .
-OBJECTIVE	The current study examined demographic , clinical , and sleep characteristics as predictors of clinically significant treatment response to brief behavioral treatment of insomnia ( BBTI ) in older adults with insomnia .
-METHODS	Thirty-nine older adults with insomnia ( 67 % females , mean age : 72.54 years ) were randomized to BBTI treatment .
-METHODS	Treatment outcomes were defined according to 2 criteria : ( 1 ) `` response , '' defined as change in Pittsburgh Sleep Quality Index ( PSQI ) score 3 points or increase in sleep diary sleep efficiency 10 % ) ; or ( 2 ) remission , defined as absence of a clinical diagnosis of insomnia according to standard diagnostic criteria .
-METHODS	Logistic regression examined whether baseline demographic , clinical , or sleep characteristics predicted treatment outcomes at 1 month follow-up .
-RESULTS	Demographic variables did not predict treatment outcomes for either criterion .
-RESULTS	Higher anxiety , depression , poorer sleep quality , and longer polysomnography ( PSG ) - assessed sleep latency predicted greater likelihood of response at follow-up ( p < 0.05 ) .
-RESULTS	Longer sleep duration at baseline ( measured by sleep diary and PSG ) predicted greater likelihood of the remission at follow-up ( p < 0.05 ) .
-CONCLUSIONS	Patients with insomnia who have greater distress at baseline or prolonged sleep latency are more likely to show positive response to BBTI .
-CONCLUSIONS	In contrast , short sleepers at baseline are less likely to have resolution of insomnia diagnosis following BBTI , perhaps due to the sleep restriction component of the treatment .
-CONCLUSIONS	Identifying the characteristics that predict positive BBTI treatment outcomes can facilitate personalized behavioral treatments to improve outcomes .
-
-###25271116
-OBJECTIVE	To compare the effects on health-related quality of life ( HRQoL ) of a 2-year intervention with a low-fat diet ( LFD ) or a low-carbohydrate diet ( LCD ) based on four group-meetings to achieve compliance .
-OBJECTIVE	To describe different aspects of taking part in the intervention following the LFD or LCD .
-METHODS	Prospective , randomized trial of 61 adults with Type 2 diabetes mellitus .
-METHODS	The SF-36 questionnaire was used at baseline , 6 , 12 and 24 months .
-METHODS	Patients on LFD aimed for 55-60 energy percent ( E % ) and those on LCD for 20 E % from carbohydrates .
-METHODS	The patients were interviewed about their experiences of the intervention .
-RESULTS	Mean body-mass-index was 32.7 5.4 kg/m ( 2 ) at baseline .
-RESULTS	Weight-loss did not differ between groups and was maximal at 6 months , LFD : -3.99 4.1 kg , LCD : -4.31 3.6 kg ( p < 0.001 within groups ) .
-RESULTS	There was an increase in the physical component score of SF-36 from 44.1 ( 10.0 ) to 46.7 ( 10.5 ) at 12 months in the LCD group ( p < 0.009 ) while no change occurred in the LFD group ( p < 0.03 between groups ) .
-RESULTS	At 12 months the physical function , bodily pain and general health scores improved within the LCD group ( p values 0.042-0 .009 ) while there was no change within the LFD group .
-CONCLUSIONS	Weight-changes did not differ between the diet groups while improvements in HRQoL only occurred after one year during treatment with LCD .
-CONCLUSIONS	No changes of HRQoL occurred in the LFD group in spite of a similar reduction in body weight .
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-###24722261
-BACKGROUND	Antifibrinolytics have been used for 2 decades to reduce bleeding in cardiac surgery .
-BACKGROUND	MDCO-2010 is a novel , synthetic , serine protease inhibitor .
-BACKGROUND	We describe the first experience with this drug in patients .
-METHODS	In this phase II , double-blind , placebo-controlled study , 32 patients undergoing isolated primary coronary artery bypass grafting with cardiopulmonary bypass were randomly assigned to 1 of 5 increasing dosage groups of MDCO-2010 .
-METHODS	The primary aim was to evaluate pharmacokinetics ( PK ) with assessment of plasmatic concentrations of the drug , short-term safety , and tolerance of MDCO-2010 .
-METHODS	Secondary end points were influence on coagulation , chest tube drainage , and transfusion requirements .
-RESULTS	PK analysis showed linear dosage-proportional correlation between MDCO-2010 infusion rate and PK parameters .
-RESULTS	Blood loss was significantly reduced in the 3 highest dosage groups compared with control ( P = 0.002 , 0.004 and 0.011 , respectively ) .
-RESULTS	The incidence of allogeneic blood product transfusions was lower with MDCO-2010 4/24 ( 17 % ) vs 4/8 ( 50 % ) in the control group .
-RESULTS	MDCO-2010 exhibited dosage-dependent antifibrinolytic effects through suppression of D-dimer generation and inhibition of tissue plasminogen activator-induced lysis in ROTEM analysis as well as anticoagulant effects demonstrated by prolongation of activated clotting time and activated partial thromboplastin time .
-RESULTS	No systematic differences in markers of end organ function were observed among treatment groups .
-RESULTS	Three patients in the MDCO-2010 groups experienced serious adverse events .
-RESULTS	One patient experienced intraoperative thrombosis of venous grafts considered possibly related to the study drug .
-RESULTS	No reexploration for mediastinal bleeding was required , and there were no deaths .
-CONCLUSIONS	This first-in-patient study demonstrated dosage-proportional PK for MDCO-2010 and reduction of chest tube drainage and transfusions in patients undergoing primary coronary artery bypass grafting .
-CONCLUSIONS	Antifibrinolytic and anticoagulant effects were demonstrated using various markers of coagulation .
-CONCLUSIONS	MDCO-2010 was well tolerated and showed an acceptable initial safety profile .
-CONCLUSIONS	Larger multi-institutional studies are warranted to further investigate the safety and efficacy of this compound .
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-###24311644
-BACKGROUND	In patients with brain tumors , the choice of antiepileptic medication is guided by tolerability and pharmacokinetic interactions .
-BACKGROUND	This study investigated the effectiveness of levetiracetam ( LEV ) and pregabalin ( PGB ) , 2 non-enzyme-inducing agents , in this setting .
-METHODS	In this pragmatic , randomized , unblinded phase II trial ( NCT00629889 ) , patients with primary brain tumors and epilepsy were titrated to a monotherapy of LEV or PGB .
-METHODS	Efficacy and tolerability were assessed using structured questionnaires .
-METHODS	The primary composite endpoint was the need to discontinue the study drug , add-on of a further antiepileptic treatment , or occurrence of at least 2 seizures with impaired consciousness during 1 year follow-up .
-RESULTS	Over 40 months , 25 patients were randomized to LEV , and 27 to PGB .
-RESULTS	Most were middle-aged men , with a high-grade tumor and at least one generalized convulsion .
-RESULTS	Mean daily doses were 1125 mg ( LEV ) and 294 mg ( PGB ) .
-RESULTS	Retention rates were 59 % in the LEV group , and 41 % in the PGB group .
-RESULTS	The composite endpoint was reached in 9 LEV and 12 PGB patients-need to discontinue : side effects , 6 LEV , 3 PGB ; lack of efficacy , 1 and 2 ; impaired oral administration , 0 and 2 ; add-on of another agent : 1 LEV , 4 PGB ; and seizures impairing consciousness : 1 in each .
-RESULTS	Seven LEV and 5 PGB subjects died of tumor progression .
-CONCLUSIONS	This study shows that LEV and PGB represent valuable monotherapy options in this setting , with very good antiepileptic efficacy and an acceptable tolerability profile , and provides important data for the design of a phase III trial .
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-###24268590
-BACKGROUND	Influenza causes substantial morbidity and mortality worldwide .
-BACKGROUND	Few data exist for the efficacy of neuraminidase inhibitors , which are the only readily available influenza treatment options , especially in low-income settings .
-BACKGROUND	We assessed the efficacy of treatment with the neuraminidase inhibitor oseltamivir to reduce patient illness and viral shedding in people with influenza , in whom treatment was started within 5 days of symptom onset , in an urban setting in Bangladesh .
-METHODS	We undertook a double-blind , randomised , controlled trial between May , 2008 , and December , 2010 .
-METHODS	Patients with a positive rapid influenza test identified by surveillance of households in Kamalapur , Bangladesh were randomly allocated on a 1:1 basis to receive oseltamivir or placebo twice daily for 5 days .
-METHODS	Randomisation lists for individuals enrolled less than 48 h and 48 h or longer since illness onset were generated with permuted blocks of variable length between two and eight .
-METHODS	Participants and study staff were masked to treatment group .
-METHODS	Participants provided nasal wash specimens at enrolment and 2 , 4 , and 7 days later , and were visited daily to record symptoms .
-METHODS	All specimens were tested for influenza with reverse-transcriptase PCR , and if the result was positive , we isolated the virus .
-METHODS	The primary endpoints were duration of clinical illness and viral shedding in patients treated less than and more than 48 h since illness onset and the frequency of oseltamivir resistance during treatment .
-METHODS	Analyses were intention to treat unless otherwise specified .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT00707941 .
-RESULTS	Overall , 1190 people with a median age of 5 years ( IQR 2-9 ) were enrolled : 794 ( 67 % ) less than 48 h since symptom onset and 396 ( 33 % ) 48 h or longer since symptom onset .
-RESULTS	592 participants were assigned to placebo and 598 to oseltamivir .
-RESULTS	The median duration of symptoms was shorter in the oseltamivir group ( 3 days , IQR 1-5 ) than in the placebo group ( 4 days , 1-6 ; p = 0.01 ) .
-RESULTS	When stratified by timing of treatment initiation , in participants enrolled 48 h or longer since illness onset , the median duration of symptoms was similar in both groups ( oseltamivir 3 days [ IQR 2-5 ] , placebo 3 days [ 1-5 ] ; p = 0.04 ) .
-RESULTS	The median duration of symptoms was reduced by 1 day in the group given oseltamivir who were enrolled less than 48 h since symptom onset compared with those given placebo , but this difference was not significant .
-RESULTS	In those with all swab specimens ( n = 1134 ) , oseltamivir significantly reduced virus isolation on days 2 ( placebo 374 [ 66 % ] vs oseltamivir 321 [ 56 % ] ; difference 15.2 % , 95 % CI 9.5-20 .8 , p = 0.0004 ) , 4 ( 241 [ 43 % ] vs 174 [ 30 % ] ; difference 30.2 % , 95 % CI 24.6-35 .8 , p < 0.0001 ) , and 7 ( 68 [ 12 % ] vs 36 [ 6 % ] ; difference 47.5 % , 95 % CI 44.2-50 .8 , p = 0.0009 ) .
-RESULTS	In participants enrolled 48 h or longer since illness onset , oseltamivir treatment significantly reduced virus isolation on days 2 and 4 , but not day 7 .
-RESULTS	In participants enrolled less than 48 h since illness onset , oseltamivir treatment significantly reduced virus isolation on days 2 , 4 , and 7 .
-RESULTS	The emergency of resistance to oseltamivir during treatment was rare overall ( < 1 % ) and in influenza A H1N1pdm09 viruses ( 3.9 % ) .
-CONCLUSIONS	Oseltamivir treatment resulted in a modest reduction in the duration of symptoms and virus shedding in people with uncomplicated influenza infections , even when treatment was started 48 h or longer after illness onset .
-BACKGROUND	Centers for Disease Control and Prevention ( in agreement with the International Centre for Diarrhoeal Disease Research , Bangladesh ) .
-
-###24885549
-BACKGROUND	The severity and course of spinal pain is poorly understood in adolescents .
-BACKGROUND	The study aimed to determine the prevalence and two-year incidence , as well as the course , frequency , and intensity of pain in the neck , mid back , and low back ( spinal pain ) .
-METHODS	This study was a school-based prospective cohort study .
-METHODS	All 5th and 6th grade students ( 11-13 years ) at 14 schools in the Region of Southern Denmark were invited to participate ( N = 1,348 ) .
-METHODS	Data were collected in 2010 and again two years later , using an e-survey completed during school time .
-RESULTS	The lifetime prevalence of spinal pain was 86 % and 89 % at baseline and follow-up , respectively .
-RESULTS	A group of 13.6 % ( 95 % CI : 11.8 , 15.6 ) at baseline and 19.5 % ( 95 % CI : 17.1 , 22.0 ) at follow-up reported that they had pain frequently .
-RESULTS	The frequency of pain was strongly associated with the intensity of pain , i.e. , the majority of the participants reported their pain as relatively infrequent and of low intensity , whereas the participants with frequent pain also experienced pain of higher intensity .
-RESULTS	The two-year incidence of spinal pain varied between 40 % and 60 % across the physical locations .
-RESULTS	Progression of pain from one to more locations and from infrequent to more frequent was common over the two-year period .
-CONCLUSIONS	Spinal pain is common at the age of 11-15 years , but some have more pain than others .
-CONCLUSIONS	The pain is likely to progress , i.e. , to more locations , higher frequency , and higher pain intensity over a two-year period .
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-###24564308
-OBJECTIVE	To evaluate the cardiorespiratory effects of IV administration of propofol ( 4 mg/kg ) , ketamine hydrochloride and propofol ( 2 mg/kg each ; K-P ) , or ketamine hydrochloride ( 5 mg/kg ) and diazepam ( 0.2 mg/kg ; K-D ) before and after induction of anesthesia ( IoA ) in dogs sedated with acepromazine maleate and oxymorphone hydrochloride .
-METHODS	10 healthy adult Beagles .
-METHODS	Each dog was randomly allocated to receive 2 of 3 treatments ( 1-week interval ) .
-METHODS	For instrumentation prior to each treatment , each dog was anesthetized with isoflurane .
-METHODS	After full recovery , acepromazine ( 0.02 mg/kg ) and oxymorphone ( 0.05 mg/kg ) were administered IV .
-METHODS	Fifteen minutes later ( before IoA ) , each dog received treatment IV with propofol , K-P , or K-D .
-METHODS	Cardiorespiratory and arterial blood gas variables were assessed before , immediately after , and 5 minutes after IoA .
-RESULTS	Compared with findings before IoA , dogs receiving the K-P or K-D treatment had increased cardiac output , oxygen delivery , and heart rate 5 minutes after IoA ; K-P administration did not change mean arterial blood pressure or stroke volume and decreased systemic vascular resistance .
-RESULTS	Propofol decreased mean arterial blood pressure and systemic vascular resistance immediately after IoA but did not change heart rate , cardiac output , or oxygen delivery .
-RESULTS	All treatments caused some degree of apnea , hypoventilation , and hypoxemia ( Pao2 < 80 mm Hg ) .
-CONCLUSIONS	In dogs , K-P treatment maintained mean arterial blood pressure better than propofol alone and increased heart rate , cardiac output , or oxygen delivery , as did the K-D treatment .
-CONCLUSIONS	Supplemental 100 % oxygen should be provided during IoA with all 3 treatments .
-
-###25531993
-OBJECTIVE	Antibiotic resistance is the main reason for failure of Helicobacter pylori ( H. pylori ) treatment .
-OBJECTIVE	Currently , guidelines recommend a treatment guided by antimicrobial susceptibility testing after two failures .
-OBJECTIVE	However , microbial culture is not feasible everywhere , and the limited number of effective antibiotics against the bacterium narrows the options ; thus a rescue therapy combining antibiotics with a low resistance may be fitting .
-METHODS	Patients who have failed a first-line treatment ( either prolonged triple or sequential regimens ) and , successively , a levofloxacin-based triple therapy were considered for the study .
-METHODS	Subjects underwent urea breath test ( UBT ) , stool antigen test ( ST ) and endoscopy/histology to confirm the diagnosis .
-METHODS	Cytopenia and impaired liver and kidney function were exclusion criteria .
-METHODS	Fifty-four subjects were randomized 1:1 to two regimens : RMB Rabeprazole/Rifabutin/Minocycline / Bismuth sub-citrate or MTB Rabeprazole/Tinidazole/Minocycline / Bismuth sub-citrate both for 10 days .
-METHODS	The results were checked 6 weeks after the end of therapy with ST/UBT plus endoscopy when indicated .
-RESULTS	RMB eradicated the bacterium in 21 patients .
-RESULTS	Two subjects dropped out .
-RESULTS	The eradication rate was 77.7 % ( CI 62.0-93 .4 % ) at intention-to-treat and 84.0 % ( CI 69.6-98 .4 % ) at per-protocol analysis .
-RESULTS	MTB was successful in 14 patients ( 51.9 % , CI 33.1-70 .7 % ) .
-RESULTS	No patient withdrew from the treatment for adverse events .
-RESULTS	Drug-related side effects were reported only in 3 subjects , but in all cases the treatment was carried on .
-CONCLUSIONS	The association minocycline/rifabutin seems to have a synergic effect and a good therapeutic outcome in patients who have failed at least two previous regimens , although a trial on a large population is needed .
-
-###25454938
-OBJECTIVE	To assess the effect of automated adjustment of the inspired oxygen fraction ( FiO2 ) on arterial oxygen saturation ( SpO2 ) and cerebral tissue oxygen saturation ( SctO2 ) in very low birth weight infants with frequent fluctuations in oxygenation .
-METHODS	Fifteen infants ( median gestational age , 25 weeks [ range , 23-28 weeks ] ; median age , 34 days [ range , 19-74 days ] ) were assigned in random sequence to 24 hours of automated adjustment of FiO2 or manual adjustment of FiO2 .
-METHODS	Primary outcome measurements were time within the SpO2 target range and the area under the curve above and below a defined SctO2 range .
-RESULTS	Percentage of time within the SpO2 target range increased during automated FiO2 control ( 76.3 % 9.2 % vs 69.1 % 8.2 % for manual ; P < .01 ) .
-RESULTS	Prolonged episodes with SpO2 < 88 % of > 60 seconds duration ( median , 115 episodes [ range , 67-240 ] vs 54 episodes [ range , 7-184 ] ; P < .01 ) and of > 180 seconds duration ( median , 13 episodes [ range , 6-39 ] vs 2 episodes [ range , 0-5 ] ; P < .01 ) decreased significantly during the automated period .
-RESULTS	Percentage of time with SpO2 > 96 % decreased during automated control ( 6.6 % 4.4 % vs 10.4 % 3.3 % ; P < .02 ) .
-RESULTS	There was no significant difference in FiO2 exposure .
-RESULTS	The area ( deviation time ) below and above the defined SctO2 threshold did not differ between the 2 periods ( median , 59.7 % * seconds [ range , 17.2 % -208.3 % ] for manual vs 49.0 % * seconds [ range , 4.3 % -193.7 % ] for automated ; P = .36 ) .
-CONCLUSIONS	Automated FiO2 control in preterm infants with frequent SpO2 fluctuations significantly increased the time within the SpO2 target range and reduced the incidence of prolonged hypoxemic events compared with manual FiO2 adjustment , but did not significantly affect cerebral tissue oxygenation .
-
-###25091790
-BACKGROUND	In patients with severe sepsis , no randomized clinical trial has tested the concept of de-escalation of empirical antimicrobial therapy .
-BACKGROUND	This study aimed to compare the de-escalation strategy with the continuation of an appropriate empirical treatment in those patients .
-METHODS	This was a multicenter non-blinded randomized noninferiority trial of patients with severe sepsis who were randomly assigned to de-escalation or continuation of empirical antimicrobial treatment .
-METHODS	Recruitment began in February 2012 and ended in April 2013 in nine intensive care units ( ICUs ) in France .
-METHODS	Patients with severe sepsis were assigned to de-escalation ( n = 59 ) or continuation of empirical antimicrobial treatment ( n = 57 ) .
-METHODS	The primary outcome was to measure the duration of ICU stay .
-METHODS	We defined a noninferiority margin of 2 days .
-METHODS	If the lower boundary of the 95 % confidence interval ( CI ) for the difference in patients assigned to the de-escalation group was less than 2 days , as compared with that of patients assigned to the continuation group , de-escalation was considered to be noninferior to the continuation strategy .
-METHODS	Secondary outcomes included mortality at 90 days , occurrence of organ failure , number of superinfections , and number of days with antibiotics during the ICU stay .
-RESULTS	The median duration of ICU stay was 9 [ interquartile range ( IQR ) 5-22 ] days in the de-escalation group and 8 [ IQR 4-15 ] days in the continuation group , respectively ( P = 0.71 ) .
-RESULTS	The mean difference was 3.4 ( 95 % CI -1.7 to 8.5 ) .
-RESULTS	A superinfection occurred in 16 ( 27 % ) patients in the de-escalation group and six ( 11 % ) patients in the continuation group ( P = 0.03 ) .
-RESULTS	The numbers of antibiotic days were 9 [ 7-15 ] and 7.5 [ 6-13 ] in the de-escalation group and continuation group , respectively ( P = 0.03 ) .
-RESULTS	Mortality was similar in both groups .
-CONCLUSIONS	As compared to the continuation of the empirical antimicrobial treatment , a strategy based on de-escalation of antibiotics resulted in prolonged duration of ICU stay .
-CONCLUSIONS	However , it did not affect the mortality rate .
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-###25239172
-OBJECTIVE	To evaluate the effect of a hamstring block for postoperative pain management using 20 mL of 0.25 % bupivacaine compared with placebo after anterior cruciate ligament ( ACL ) reconstruction with a hamstring autograft .
-METHODS	In a 3-month period , 45 patients undergoing ACL reconstruction with a hamstring autograft who all received a femoral nerve block were randomized to receive either 20 mL of 0.25 % bupivacaine or 20 mL of saline water administered through a catheter into the donor-site space .
-METHODS	The patients and recovery staff were blinded to the treatment .
-METHODS	Postoperative donor-site pain was evaluated subjectively by the patients using a pain score ( Likert scale from 0 to 10 ) .
-METHODS	The pain was registered for each hour in the first 6 hours and thereafter once daily for 8 days .
-METHODS	Furthermore , the requirement for postoperative analgesic medicine was registered .
-RESULTS	The hamstring block group ( n = 23 ) had significantly less pain for each of the first 6 postoperative hours .
-RESULTS	The pain score was reduced from 4.2 to 2.3 ( 95 % confidence interval , 1.3 to 3.3 ) ( P = .01 ) in the first hour and from 2.8 to 1.3 ( 95 % confidence interval , 0.6 to 1.9 ) in the sixth hour , and there was a significantly lower overall requirement for early postoperative fentanyl , reduced from a mean of 58 to 35 g ( P = .02 ) , and morphine , reduced from a mean of 10 to 6 mg ( P = .04 ) .
-RESULTS	After 6 hours , there was no difference in the pain level and use of analgesics between the 2 groups .
-CONCLUSIONS	With the use of a donor-site block in hamstring ACL reconstruction , the donor-site pain level , as well as the overall requirement for fentanyl and morphine , was significantly reduced in the first 6 postoperative hours .
-CONCLUSIONS	No effect of the donor-site block was seen after 6 hours .
-METHODS	Level I , therapeutic , randomized controlled study .
-
-###24424561
-OBJECTIVE	The aim of this study was to evaluate the effect of a low tube voltage technique and hybrid iterative reconstruction ( HIR ) on image quality at 3-dimensional computed tomographic angiography ( 3D-CTA ) of the liver .
-METHODS	Before hepatic surgery , we randomly assigned 60 patients ( 17 women , 43 men ; mean SD age , 68.9 10.1 years ) who had undergone 3D-CTA to 1 of 2 protocols ; 30 patients underwent scanning under the conventional 120-kilovolt ( peak ) protocol with filtered back projection ( P1 ) ; and 30 patients , under an 80-kilovolt ( peak ) protocol with HIR ( P2 ) .
-METHODS	The estimated effective radiation dose , computed tomographic attenuation , image noise , contrast-to-noise ratio , and figure of merit were calculated , and the visual image quality of 3D-CTA was scored on a 4-point scale .
-RESULTS	The mean effective radiation dose was significantly lower under P2 than P1 ( 4.8 1.2 vs 7.2 1.5 mSv , P < 0.01 ) .
-RESULTS	P1 and P2 did not significantly differ with respect to the image noise ( 10.5 2.3 vs 9.9 1.6 Hounsfield units ; P = 0.46 ) .
-RESULTS	Computed tomographic attenuation , contrast-to-noise ratio , figure of merit , and the visual scores for image quality were higher under P2 than P1 ( P < 0.01 ) .
-CONCLUSIONS	The use of low tube voltage and HIR can yield significantly improved image quality at 3D-CTA of the liver .
-
-###25161019
-OBJECTIVE	To improve arterial catheter ( AC ) securement and reduce AC failure ; to assess feasibility of a large randomised controlled trial .
-METHODS	A four-arm , parallel , randomised , controlled , non-blinded pilot trial with 195 intensive care patients taking part , in a tertiary referral hospital in Brisbane , Australia from May to November 2012 .
-METHODS	Standard polyurethane ( SPU ) dressing ( controls ) ; bordered polyurethane ( BPU ) + SPU dressing ; tissue adhesive ( TA ) + SPU dressing ; and sutureless securement device ( SSD ) + SPU dressing ( no sutures used ) .
-METHODS	AC failure , ie , complete dislodgement , occlusion ( monitor failure , inability to infuse or fluid leaking ) , pain or infection ( local or blood ) .
-RESULTS	Median AC dwell time was 26.2 hours and was comparable between groups .
-RESULTS	AC failure occurred in 26/195 patients ( 13 % ) .
-RESULTS	AC failure was significantly worse with SPU dressings ( 10/47 [ 21 % ] ) than with BPU + SPU dressings ( 2 / 43 [ 5 % ] ; P = 0.03 ) , but not significantly different to TA + SPU ( 6/56 [ 11 % ] ; P = 0.18 ) or SSD + SPU ( 8/49 [ 16 % ] ; P = 0.61 ) .
-RESULTS	The dressing applied at AC insertion lasted until AC removal in 68 % of controls ; 56 % of BPU + SPU dressings ; 73 % of TA + SPU dressings ; and 80 % of SSD + SPU dressings ( all P > 0.05 ) .
-RESULTS	There were no infections or serious adverse events .
-RESULTS	Patient and staff satisfaction with all products was high .
-RESULTS	Median costs ( labour and materials ) for securement per patient were significantly higher in all groups compared with the control group ( SPU , $ 3.48 [ IQR , $ 3.48 - $ 9.79 ] ; BPU + SPU , $ 5.07 [ IQR , $ 5.07 - $ 12.99 ] ; SSD + SPU , $ 10.90 [ IQR , $ 10.90 - $ 10.90 ] ; TA + SPU , $ 17.70 [ IQR , $ 17.70 - $ 38.36 ] ; all P < 0.01 ) .
-CONCLUSIONS	AC failure occurred significantly less often with BPU + SPU dressings than with SPU dressings .
-CONCLUSIONS	TA + SPU and SSD + SPU dressings should be further investigated and compared with BPU + SPU dressings as controls .
-CONCLUSIONS	The novel approach of TA + SPU dressings appeared safe and feasible .
-
-###25243819
-OBJECTIVE	To evaluate the veterinary student learning outcome of 2 methods of equine rectal examination training .
-METHODS	Randomized prospective study .
-METHODS	Veterinary students ( 3rd and 4th year ; n = 40 ) and practicing equine veterinarians ( n = 10 ) .
-METHODS	Year 1 : Group 1 ( n = 11 ) and Group 2 students ( n = 10 ) received skilled instructor ( SI ) and laparoscopic-guidance ( LG ) , respectively , during rectal exam instruction .
-METHODS	All students were tested on rectal identification of 4 abdominal organs .
-METHODS	Year 2 : One group of students ( n = 19 ) was trained and subsequently tested using each technique , first SI , followed by LG .
-METHODS	Subjective evaluation of laparoscopy as a teaching tool was achieved with veterinary students and equine practitioners .
-RESULTS	A significantly greater percentage of students having LG compared to SI were able to correctly identify the left kidney ( Year 1 ) and the spleen , cecum , and right ovary ( Year 2 ) .
-RESULTS	A significantly greater proportion of LG trained students in years 1 and 2 ( 100 % and 95 % , respectively ) were also able to identify 75 % of organs compared with SI ( 27 % and 21 % , respectively ) .
-RESULTS	Both students and veterinarians uniformly provided favorable feedback for LG in teaching rectal palpation skills .
-CONCLUSIONS	The LG method of equine rectal examination instruction resulted in improved learning for identification of several key abdominal organs compared with SI .
-
-###24572769
-OBJECTIVE	We report our experience with a modified mini-maze procedure and pulmonary vein isolation using radiofrequency energy for treating persistent atrial fibrillation during coronary artery bypass grafting ( CABG ) .
-METHODS	Ninety-five patients with persistent atrial fibrillation and coronary heart disease underwent open heart surgery combined with intraoperative irrigated radiofrequency ablation .
-METHODS	Patients were randomized into the following three groups : CABG and irrigated radiofrequency pulmonary vein isolation ( CABG+PVI , n = 31 ) ; CABG and an irrigated radiofrequency modified mini-maze procedure ( CABG+MM , n = 30 ) ; and isolated CABG ( CABG alone , n = 34 ) .
-METHODS	All patients received implantable loop recorders .
-RESULTS	No reoperation and no hospital mortality were recorded .
-RESULTS	Mean follow-up was 14.4 9.7 months .
-RESULTS	The implantable loop recorder-determined freedom from atrial fibrillation was 80 % in the CABG+PVI group , 86.2 % in the CABG+MM group and 44.1 % in the CABG alone group .
-CONCLUSIONS	Patients with concomitant atrial fibrillation and coronary heart disease may benefit from intraoperative ablation to prevent relapse of arrhythmia .
-
-###25042182
-BACKGROUND	Dystrophinopathy is a rare , severe muscle disorder , and nonsense mutations are found in 13 % of cases .
-BACKGROUND	Ataluren was developed to enable ribosomal readthrough of premature stop codons in nonsense mutation ( nm ) genetic disorders .
-METHODS	Randomized , double-blind , placebo-controlled study ; males 5 years with nm-dystrophinopathy received study drug orally 3 times daily , ataluren 10 , 10 , 20 mg/kg ( N = 57 ) ; ataluren 20 , 20 , 40 mg/kg ( N = 60 ) ; or placebo ( N = 57 ) for 48 weeks .
-METHODS	The primary endpoint was change in 6-Minute Walk Distance ( 6MWD ) at Week 48 .
-RESULTS	Ataluren was generally well tolerated .
-RESULTS	The primary endpoint favored ataluren 10 , 10 , 20 mg/kg versus placebo ; the week 48 6MWD = 31.3 meters , post hoc P = 0.056 .
-RESULTS	Secondary endpoints ( timed function tests ) showed meaningful differences between ataluren 10 , 10 , 20 mg/kg , and placebo .
-CONCLUSIONS	As the first investigational new drug targeting the underlying cause of nm-dystrophinopathy , ataluren offers promise as a treatment for this orphan genetic disorder with high unmet medical need .
-
-###25861467
-OBJECTIVE	Increased coagulation activation may contribute to the high incidence of cardiovascular complications observed in obese and type 2 diabetes ( T2D ) subjects .
-OBJECTIVE	Although tissue factor ( TF ) , the primary initiator of coagulation is increased in obesity , its expression in adipose tissues and its association with metabolic parameters are unclear .
-OBJECTIVE	We sought to compare TF expression in plasma and adipose tissues of obese subjects with and without T2D , its correlation with metabolic parameters , and regulation in response to antidiabetic drugs .
-METHODS	Subjects were recruited from diabetes clinics and adipose tissue was obtained by needle biopsy of lower subcutaneous abdominal depot .
-METHODS	For the intervention study , subjects were randomized into treatment groups with rosiglitazone or metformin for 4 months .
-RESULTS	Plasma TF antigen , activity , and adipose TF mRNA were greater in obese T2D subjects compared with obese nondiabetics .
-RESULTS	Plasma TF activity correlated with fasting insulin , glucose , and free fatty acids , ( FFAs ) , and adipose TF mRNA correlated with plasma FFA .
-RESULTS	Plasma TF activity was reduced by metformin and increased with rosiglitazone treatment .
-CONCLUSIONS	Specific diabetes-related metabolic parameters , but not obesity per se , are correlated with TF expression .
-CONCLUSIONS	Regulation of TF activity by different classes of antidiabetic drugs may relate to protective or adverse cardiovascular outcomes .
-
-###24715425
-OBJECTIVE	To observe the effects of Liuwei Dihuang Granule ( [ symbols ; see text ] , LDG ) for tonifying Kidney ( Shen ) on the outcomes of in vitro fertilization pre-embryo transfer ( IVF-ET ) of infertility women with Kidney-yin deficiency syndrome and to explore its mechanism by detecting the proteome expression in the follicular fluid .
-METHODS	Sixty-six infertility patients of Kidney-yin deficiency syndrome who would undergo IVF-ET , were randomly assigned to a treatment group and a control group according to a random number table , 33 cases in each group .
-METHODS	Another 33 cases of non-Kidney-yin deficiency syndrome was taken as a syndrome-control group .
-METHODS	Besides Western routine therapy , LDG was given 3 menstrual cycles before IVF to the treatment group , and a placebo granule to the control and syndrome-control groups .
-METHODS	The scores of Kidney-yin deficiency symptoms ( sore waist and knees , dry vagina , dysphoria with feverish sensation in the chest , palms and soles , etc. ) were assessed , the number of retrieved oocytes , rates of high quality oocytes and embryos , fertility rate and clinical pregnancy rate were recorded , and the follicular fluid was collected on the day when the ovum was picked up , the differential protein expression was detected using two-dimensional gel electrophoresis , and then , matrix assisted laser desorption ionization time-of flight mass spectrometry ( MALDI-TOF-MS ) was applied to identify the proteins .
-RESULTS	The syndrome score in the treatment group decreased significantly from 16.092.58 to 8.672.13 , while it changed insignificantly in the control group , with a significant difference in the lowering score between the two groups ( P < 0.05 ) ; the high quality rates of oocytes and embryos and clinical pregnancy rate were all superior in the treatment group to the control group ( 82.29 % vs 78.08 % , 76.76 % vs 68.79 % , 63.64 % vs 36.36 % , all P < 0.05 ) .
-RESULTS	The protein expression map from the follicular fluid showed that compared with the control group , 33 differential protein expressions were found in the syndrome-control group , among which 18 were down-regulated , and 15 up-regulated ; in the treatment group 28 differential protein expressions were found , among which 15 were down-regulated , and 13 up-regulated .
-RESULTS	Through MALDI-TOF-MS , 14 proteins were identified ( P < 0.05 ) .
-CONCLUSIONS	For the infertility patients undergoing IVF , LDG could alleviate clinical symptoms , improve rates of high quality oocytes and embryos , so as to raise clinical pregnancy rate .
-CONCLUSIONS	The mechanism may be through regulating proteome expression in the follicular fluid to improve the developmental microenvironment for oocytes which would lead to a successful embryo implantation .
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-###24354839
-OBJECTIVE	We evaluated the impact of influenza vaccine text message reminders in a low-income obstetric population .
-METHODS	We conducted a randomized controlled trial that enrolled 1187 obstetric patients from 5 community-based clinics in New York City .
-METHODS	The intervention group received 5 weekly text messages regarding influenza vaccination starting mid-September 2011 and 2 text message appointment reminders .
-METHODS	Both groups received standard automated telephone appointment reminders .
-METHODS	The prespecified endpoints were receipt of either pre - or postpartum influenza vaccination calculated cumulatively at the end of each month ( September-December 2011 ) .
-RESULTS	After adjusting for gestational age and number of clinic visits , women who received the intervention were 30 % more likely to be vaccinated as of December 2011 ( adjusted odds ratio [ AOR ] = 1.30 ; 95 % confidence interval [ CI ] = 1.003 , 1.69 end of September : AOR = 1.34 ; 95 % CI = 0.98 , 1.85 ; October : AOR = 1.35 ; 95 % CI = 1.05 , 1.75 ; November : AOR = 1.27 ; 95 % CI = 0.98 , 1.65 ) .
-RESULTS	The subgroup of women early in the third trimester at randomization showed the greatest intervention effect ( December 31 : 61.9 % intervention vs 49.0 % control ; AOR = 1.88 ; 95 % CI = 1.12 , 3.15 ) .
-CONCLUSIONS	In this low-income obstetric population , text messaging was associated with increased influenza vaccination , especially in those who received messages early in their third trimester .
-
-###24912060
-OBJECTIVE	Despite the large number of Latinos living in the United States , little research has evaluated the effectiveness of different vocational rehabilitation programs for individuals with severe mental illness in this rapidly growing minority population .
-OBJECTIVE	This article presents a secondary analysis of a randomized , controlled trial comparing supported employment with 2 other vocational rehabilitation programs in 3 ethnic/racial groups of participants with severe mental illness : Latinos , non-Latino African Americans , and non-Latino Whites .
-METHODS	The data were drawn from a previously published randomized , controlled trial comparing supported employment with standard vocational rehabilitation services and a psychosocial clubhouse program in persons with severe mental illness ( Mueser et al. , 2004 ) , including 64 Latinos , 91 non-Latino African Americans , and 43 non-Latino Whites .
-METHODS	Comparisons were made between the 3 groups at baseline on demographic characteristics , clinical and psychosocial functioning , and quality of life .
-METHODS	Within each ethnic/racial group , competitive employment and all paid employment outcomes were compared between the 3 vocational rehabilitation programs over the 2-year study period .
-RESULTS	At baseline , the Latino participants had lower levels of education and disability income , were less likely to have worked competitively over the previous 5 years , had more severe symptoms , and worse psychosocial functioning than the non-Latino African American or non-Latino White participants .
-RESULTS	Latinos randomized to supported employment had better competitive and all-paid work outcomes than those assigned to either standard services or the psychosocial clubhouse program , similar to the non-Latino consumers .
-RESULTS	Rates of competitive work for consumers in supported employment were comparable across all 3 racial/ethnic groups .
-CONCLUSIONS	Supported employment is effective at improving competitive work in Latinos with severe mental illness .
-CONCLUSIONS	Efforts should be made to increase access to supported employment in the growing population of Latinos with severe mental illness .
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-###25386609
-OBJECTIVE	A new , novel product , Cynatine HNS , was evaluated for its effects as a supplement for improving various aspects of hair and nails in a randomized , double-blind , placebo-controlled clinical trial .
-METHODS	A total of 50 females were included and randomized into two groups .
-METHODS	The active group ( n = 25 ) received 2 capsules containing Cynatine HNS , comprised of Cynatine brand keratin ( 500 mg ) plus vitamins and minerals , per day , and the placebo group ( n = 25 ) received 2 identical capsules of maltodextrin per day for 90 days .
-METHODS	End points for hair loss , hair growth , hair strength , amino acid composition , and hair luster were measured .
-METHODS	End points were also measured for nail strength and the appearance of nails .
-RESULTS	The results show that subjects taking Cynatine HNS showed statistically significant improvements in their hair and nails when compared to placebo .
-CONCLUSIONS	Cynatine HNS is an effective supplement for improving hair and nails in 90 days or less .
-CONCLUSIONS	EudraCT number is 2014-002645-22 .
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-###25001961
-BACKGROUND	Individuals with schizophrenia have functionally significant deficits in automatic and controlled social cognition , but no currently available pharmacologic treatments reduce these deficits .
-BACKGROUND	The neuropeptide oxytocin has multiple prosocial effects when administered intranasally in humans and there is growing interest in its therapeutic potential in schizophrenia .
-METHODS	We administered 40 IU of oxytocin and saline placebo intranasally to 29 male subjects with schizophrenia and 31 age-matched , healthy controls in a randomized , double-blind , placebo-controlled , cross-over study .
-METHODS	Social cognition was assessed with The Awareness of Social Inference Test ( TASIT ) and the Reading the Mind in the Eyes Test ( RMET ) .
-METHODS	We examined the effects of oxytocin administration on automatic social cognition ( the ability to rapidly interpret and understand emotional cues from the voice , face , and body ) ; controlled social cognition ( the ability to comprehend indirectly expressed emotions , thoughts , and intentions through complex deliberations over longer time periods ) ; and a control task ( the ability to comprehend truthful dialog and perform general task procedures ) in individuals with and without schizophrenia using mixed factorial analysis of variance models .
-RESULTS	Patients with schizophrenia showed significant impairments in automatic and controlled social cognition compared to healthy controls , and administration of oxytocin significantly improved their controlled , but not automatic , social cognition , F ( 1 , 58 ) = 8.75 ; p = 0.004 .
-RESULTS	Conversely , oxytocin administration had limited effects on social cognition in healthy participants .
-RESULTS	Patients and controls performed equally well and there were no effects of oxytocin administration on the control task .
-CONCLUSIONS	Intact social cognitive abilities are associated with better functional outcomes in individuals with schizophrenia .
-CONCLUSIONS	Our data highlight the potentially complex effects of oxytocin on some but not all aspects of social cognition , and support the exploration of intranasal oxytocin as a potential adjunct treatment to improve controlled social cognition in schizophrenia .
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-###25311600
-OBJECTIVE	To investigate associations between timing of adiposity rebound ( AR ; the period in childhood where BMI begins to increase from its nadir ) and adiposity ( BMI , fat mass ) at age 15 years in the Avon Longitudinal Study of Parents and Children ( ALSPAC ) .
-METHODS	The sample consisted of 546 children with AR derived in childhood and BMI and fat mass index ( FMI ; fat mass measured by dual-energy radiograph absorptiometry/height in m ( 2 ) ) measured at 15 years .
-METHODS	Multivariable linear regression models were based on standardized residuals of log BMI and log FMI to allow comparison of regression coefficients across outcomes .
-RESULTS	There were strong dose-response associations between timing of AR and both adiposity outcomes at 15 years independent of confounders .
-RESULTS	BMI was markedly higher in adolescence for those with very early AR ( by 3.5 years ; = 0.70 ; 95 % confidence interval [ CI ] : 0.33-1 .07 ; P .001 ) and was also higher for those with early AR ( between 3.5 and 5 years ; = 0.34 ; 95 % CI : 0.08-0 .59 ; P = .009 ) compared with those with later AR ( > 5 years ) after full adjustment for a range of potential confounders .
-RESULTS	Similar magnitudes of association were found for FMI after full adjustment for confounders ( compared with later AR : very early AR = 0.74 ; 95 % CI : 0.34-1 .15 ; P .001 ; early AR = 0.35 ; 95 % CI : 0.07-0 .63 ; P = .02 ) .
-CONCLUSIONS	Early AR is strongly associated with increased BMI and FMI in adolescence .
-CONCLUSIONS	Preventive interventions should consider targeting modifiable factors in early childhood to delay timing of AR .
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-###24568258
-METHODS	Randomized clinical trial .
-OBJECTIVE	To compare the effects of functional stabilization training ( FST ) versus standard training on knee pain and function , lower-limb and trunk kinematics , trunk muscle endurance , and eccentric hip and knee muscle strength in women with patellofemoral pain .
-BACKGROUND	A combination of hip - and knee-strengthening exercise may be more beneficial than quadriceps strengthening alone to improve pain and function in individuals with patellofemoral pain .
-BACKGROUND	However , there is limited evidence of the effectiveness of these exercise programs on the biomechanics of the lower extremity .
-METHODS	Thirty-one women were randomized to either the FST group or standard-training group .
-METHODS	Patients attended a baseline assessment session , followed by an 8-week intervention , and were reassessed at the end of the intervention and at 3 months after the intervention .
-METHODS	Assessment measures were a 10-cm visual analog scale for pain , the Lower Extremity Functional Scale , and the single-leg triple-hop test .
-METHODS	A global rating of change scale was used to measure perceived improvement .
-METHODS	Kinematics were assessed during the single-leg squat .
-METHODS	Outcome measures also included trunk endurance and eccentric hip and knee muscle strength assessment .
-RESULTS	The patients in the FST group had less pain at the 3-month follow-up and greater global improvement and physical function at the end of the intervention compared to those in the standard-training group .
-RESULTS	Lesser ipsilateral trunk inclination , pelvis contralateral depression , hip adduction , and knee abduction , along with greater pelvis anteversion and hip flexion movement excursions during the single-leg squat , were only observed in the FST group after the intervention .
-RESULTS	Only those in the FST group had greater eccentric hip abductor and knee flexor strength , as well as greater endurance of the anterior , posterior , and lateral trunk muscles , after training .
-CONCLUSIONS	An intervention program consisting of hip muscle strengthening and lower-limb and trunk movement control exercises was more beneficial in improving pain , physical function , kinematics , and muscle strength compared to a program of quadriceps-strengthening exercises alone .
-
-###24532685
-OBJECTIVE	To evaluate the 4-year results following a randomised controlled trial ( RCT ) comparing open ( ONF ) and laparoscopic ( LNF ) Nissen fundoplication in children .
-BACKGROUND	It is assumed that long-term results of ONF and LNF are comparable .
-BACKGROUND	No randomised studies have been performed in children .
-METHODS	A follow-up study was performed in children randomised to ONF or LNF ( clinicaltrials.gov identifier NCT00259961 ) .
-METHODS	Recurrent gastro-oesophageal reflux ( GER ) was documented by upper gastrointestinal contrast study and/or 24-h pH study .
-METHODS	Nutritional status , retching and other symptoms were investigated .
-METHODS	A questionnaire was used to assess the quality of life before and after surgery .
-RESULTS	Thirty-nine children were randomised to ONF ( n = 20 ) or LNF ( n = 19 ) .
-RESULTS	There were 15 ONF and 16 LNF neurologically impaired children .
-RESULTS	One patient ( ONF group ) was lost to follow-up .
-RESULTS	Follow-up was 4.1 years ( 3.1-5 .3 ) for ONF group and 4.1 years ( 2.6-5 .1 ) for LNF group ( p = 0.9 ) .
-RESULTS	Seven neurologically impaired children had died by the time of follow-up ( 3 ONF , 4 LNF ) .
-RESULTS	Incidence of recurrent GER was 12.5 % in the ONF and 20 % in the LNF ( p = ns ) .
-RESULTS	One patient in each group underwent redo-Nissen fundoplication .
-RESULTS	Nutritional status improved in both groups , as indicated by a significant increase in weight Z-score ( p < 0.01 ) .
-RESULTS	Gas bloat and dumping syndrome were present in both groups ( p = ns ) .
-RESULTS	Incidence of retching was lower in the laparoscopic group ( p = 0.01 ) .
-RESULTS	Quality of life improved in both groups ( p = ns ) .
-CONCLUSIONS	Open and laparoscopic Nissen provide similar control of reflux and quality of life at follow-up .
-CONCLUSIONS	LNF is associated with reduced incidence of retching persisting at 4-year follow-up .
-BACKGROUND	NCT00259961 .
-
-###26150444
-OBJECTIVE	To determine the efficacy of consolidation chemotherapy ( CC ) with docetaxel and cisplatin ( DP ) after concurrent chemoradiotherapy ( CCRT ) with the same agents in locally advanced non-small-cell lung cancer ( LA-NSCLC ) .
-METHODS	Patients were randomly assigned to either CCRT alone ( observation arm ) or CCRT followed by CC ( consolidation arm ) .
-METHODS	CCRT with docetaxel ( 20 mg/m ( 2 ) ) and cisplatin ( 20 mg/m ( 2 ) ) was administered every week for 6 weeks with a total dose of 66 Gy of thoracic radiotherapy in 33 fractions .
-METHODS	In the consolidation arm , patients were further treated with three cycles of DP ( 35 mg/m ( 2 ) each on days 1 and 8 , every 3 weeks ) .
-METHODS	The primary end point was 40 % improvement in progression-free survival ( PFS ) compared with observation .
-RESULTS	From October 2005 to April 2011 , 437 patients were randomly assigned .
-RESULTS	Seventeen patients did not start CCRT as a result of consent withdrawal or ineligibility reasons after random assignment , leaving 420 patients for this analysis ( n = 211 for observation ; n = 209 for consolidation ) .
-RESULTS	Patient characteristics were similar in both arms .
-RESULTS	In the consolidation arm , 143 patients ( 68 % ) received CC , of whom 88 ( 62 % ) completed three planned cycles .
-RESULTS	The median PFS was 8.1 months in the observation arm and 9.1 months in the consolidation arm ( hazard ratio , 0.91 ; 95 % CI , 0.73 to 1.12 ; P = .36 ) .
-RESULTS	Median overall survival times were 20.6 and 21.8 months in the observation and consolidation arms , respectively ( HR , 0.91 ; 95 % CI , 0.72 to 1.25 ; P = .44 ) .
-CONCLUSIONS	CC with DP after CCRT with weekly DP in LA-NSCLC failed to further prolong PFS .
-CONCLUSIONS	CCRT alone should remain the standard of care .
-
-###25200354
-BACKGROUND	In mainland China , peginterferon ( PEG-IFN ) alfa-2b 1.0 g/kg/wk for 24 weeks is the approved treatment for HBeAg-positive chronic hepatitis B.
-OBJECTIVE	This multicenter , randomized trial evaluated the safety and efficacy of regimens utilizing increased dose or treatment duration in treatment-naive Chinese patients with chronic hepatitis B.
-METHODS	670 HBeAg-positive patients from China , Malaysia , Taiwan area , Singapore , and Thailand were enrolled .
-METHODS	Patients received PEG-IFN alfa-2b 1.0 g/kg/wk ( arm A ) or 1.5 g/kg/wk ( arm B ) for 24 weeks , or 1.5 g/kg/wk for 48 weeks ( arm C ) .
-METHODS	The primary end point was loss of HBeAg 24 weeks after end of treatment .
-RESULTS	At the end of follow-up , HBeAg loss was significantly greater in arm C compared with arm A ( 31.3 % vs. 17.3 % ; P = 0.001 ) and arm B ( 31.3 % vs. 18.1 % ; P = 0.001 ) .
-RESULTS	No significant difference in the rate of HBeAg loss was observed between arms A and B.
-RESULTS	The proportions of patients with HBe seroconversion , HBV DNA levels < 20,000 IU/mL , and ALT normalization at the end of follow-up were significantly higher in arm C compared with arm A and arm B.
-RESULTS	In arms A , B , and C , rates of early treatment discontinuation were 6.3 % , 4.9 % , and 8.9 % ; of discontinuation due to an AE , 2 % , 3 % , and 3 % ; and of AEs requiring dose modification , 3 % , 6 % , and 10 % , respectively .
-CONCLUSIONS	In Chinese patients with HBeAg-positive chronic hepatitis B , PEG-IFN alfa-2b 1.5 g/kg/wk for 48 weeks is more efficacious compared with 1.0 and 1.5 g/kg/wk for 24 weeks .
-
-###24582868
-OBJECTIVE	To evaluate the impact of contact lens ( CL ) - induced corneal swelling on the optical quality of the eye by means of the double-pass technique .
-METHODS	Measurements of 6 healthy subjects were obtained in 5 visits over 1 week , at baseline and after sleeping with 4 different CLs of +0.50 D , +2.00 D , +5.00 D and +8.00 D ( Acuvue2 ) , randomly fitted on 4 different days .
-METHODS	The control eye wore no CL .
-METHODS	Corneal pachymetry and optical quality of the eye ( OQAS , Visiometrics ) were measured once at baseline and at three interval times in the follow-up visits : immediately after CL removal , and 1 and 2 h after CL removal .
-METHODS	Optical quality was evaluated by means of the Strehl ratio and OQAS values at 100 % , 20 % and 9 % contrasts .
-METHODS	Intraocular scattering was evaluated with the objective scatter index ( OSI ) .
-RESULTS	Mean overnight swelling was 5.98 4.29 % in CL-eyes versus 0.30 0.78 % in control eyes ( p < 0.01 ) .
-RESULTS	Corneal swelling was maximal immediately after CL removal and decreased with time ( p < 0.01 ) .
-RESULTS	A significant worsening in all optical quality parameters and a significant increase of the OSI were found in eyes with corneal swelling ( p < 0.05 ) .
-RESULTS	Two hours after CL removal there were no statistically significant differences ( p > 0.05 ) between CL-eyes and control eyes in any of the measured parameters .
-CONCLUSIONS	Corneal swelling has a significant impact on the optical quality of the eye and on intraocular scattering as assessed with the double-pass technique .
-
-###24983307
-BACKGROUND	Everolimus and cyclosporine A ( CsA ) exhibit synergistic immunosuppressive activity when used in combination .
-BACKGROUND	We examined the safety and efficacy of the use of everolimus with a cyclosporine-sparing strategy in de novo renal transplant recipients .
-METHODS	A comparative , parallel , randomized , open-label 1-year study has been performed in 148 patients from five transplant centers to compare the efficacy and tolerability of everolimus and reduced exposure CsA ( the investigational group ) or enteric-coated mycophenolate sodium and standard-exposure CsA ( the control group ) in combination with basiliximab and steroids .
-METHODS	The eligible subjects were randomly assigned at 1 month after transplantation .
-METHODS	Efficacy failure ( biopsy-proven acute rejection , death , graft loss , or loss to follow-up ) , safety , and renal function were evaluated .
-RESULTS	One graft loss has been reported in the control group and no patient death were reported in either group .
-RESULTS	The incidence of biopsy-proven acute rejection until 12 months after transplantation of the investigational group was 7.5 % , compared to 11.1 % of the control group ( P = 0.565 ) .
-RESULTS	The mean estimated glomerular filtration rates of the investigational group at 12 months after transplantation was significantly higher ( 68.1 16.8 ml/min/1 .73 m ( 2 ) ) than that of the control group ( 60.6 15.8 ml/min/1 .73 m ( 2 ) ; P = 0.016 ) .
-RESULTS	There was no significant difference ( P > 0.05 ) in the incidence of discontinuations and serious adverse events between the groups .
-CONCLUSIONS	The results of this study provide the evidences that ( 1 ) the calcineurin inhibitor ( CNI ) minimization by the introduction of everolimus after 1-month posttransplantation keeps the incidences of acute rejection and additional risks as low as the conventional immunosuppression ; ( 2 ) it allows minimizing CNI exposure , consequently reducing CNI nephrotoxicity and preserving renal function .
-
-###24473249
-OBJECTIVE	The purpose of this randomized controlled study was to examine and compare the immediate and retention effects of speed-dependent treadmill training ( SDTT ) and rhythmic auditory-cued ( RAC ) overground walking on gait function and fall risk in individuals with Parkinson 's disease ( PD ) .
-METHODS	Twenty participants ( mean age 66.1 yrs ) with idiopathic PD were randomized into either SDTT ( n = 10 ) or RAC ( n = 10 ) progressive , interval-based locomotor training protocols .
-METHODS	Immediate and retention training effects on gait function and fall risk were measured by comfortable and fast gait speed ( CGS , FGS ) , 6-Minute Walk Test ( 6MWT ) , and Functional Gait Assessment ( FGA ) .
-RESULTS	Immediate within-group training effects revealed significant gains in CGS , 6MWT , and FGA for the RAC group , and in FGS , 6-MinuteWalk Test , and FGA for the SDTT group .
-RESULTS	Retention effects were found at 3-month follow-up for all gait measures in the RAC group , and for FGS and FGA in the SDTT group .
-RESULTS	No statistically significant differences in immediate or retention training effects on gait measures were found between groups .
-CONCLUSIONS	Externally-cued locomotor training with progressive and interval-based speed challenges , either with RAC overground or on a treadmill , produced significant improvements in walking speed , endurance , and dynamic balance during walking .
-
-###24226808
-BACKGROUND	High-sensitivity troponin-I ( hs-TnI ) measurement improves risk assessment for cardiovascular events in many clinical settings , but the added value in atrial fibrillation patients has not been described .
-RESULTS	At randomization , hs-TnI was analyzed in 14 821 atrial fibrillation patients in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation ( ARISTOTLE ) trial comparing apixaban with warfarin .
-RESULTS	The associations between hs-TnI concentrations and clinical outcomes were evaluated by using adjusted Cox analysis .
-RESULTS	The hs-TnI assay detected troponin ( 1.3 ng/L ) in 98.5 % patients , 50 % had levels > 5.4 , 25 % had levels > 10.1 , and 9.2 % had levels 23 ng/L ( the 99th percentile in healthy individuals ) .
-RESULTS	During a median of 1.9 years follow-up , annual rates of stroke or systemic embolism ranged from 0.76 % in the lowest hs-TnI quartile to 2.26 % in the highest quartile ( > 10.1 ng/L ) .
-RESULTS	In multivariable analysis , hs-TnI was significantly associated with stroke or systemic embolism , adjusted hazard ratio 1.98 ( 1.42-2 .78 ) , P = 0.0007 .
-RESULTS	hs-TnI was also significantly associated with cardiac death ; annual rates ranged from 0.40 % to 4.24 % , hazard ratio 4.52 ( 3.05-6 .70 ) , P < 0.0001 , in the corresponding groups , and for major bleeding hazard ratio 1.44 ( 1.11-1 .86 ) , P = 0.0250 .
-RESULTS	Adding hs-TnI levels to the CHA2DS2VASc score improved c-statistics from 0.629 to 0.653 for stroke or systemic embolism , and from 0.591 to 0.731 for cardiac death .
-RESULTS	There were no significant interactions with study treatment .
-CONCLUSIONS	Troponin-I is detected in 98.5 % and elevated in 9.2 % of atrial fibrillation patients .
-CONCLUSIONS	The hs-TnI level is independently associated with a raised risk of stroke , cardiac death , and major bleeding and improves risk stratification beyond the CHA2DS2VASc score .
-CONCLUSIONS	The benefits of apixaban in comparison with warfarin are consistent regardless of hs-TnI levels .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00412984 .
-
-###24796381
-BACKGROUND	Heavy drinking among individuals with HIV is associated with major health concerns ( liver disease , medication nonadherence , immune functioning ) , but little is known about cognitive-motivational factors involved in alcohol consumption in this population , particularly reasons for limiting drinking .
-METHODS	Urban HIV primary care patients ( N = 254 ; 78.0 % male ; 94.5 % African American or Hispanic ) in a randomized trial of brief drinking-reduction interventions reported on reasons for limiting drinking , alcohol consumption , and alcohol dependence symptoms prior to intervention .
-RESULTS	Exploratory factor analysis indicated 3 main domains of reasons for limiting drinking : social reasons ( e.g. , responsibility to family ) , lifestyle reasons ( e.g. , religious/moral reasons ) , and impairment concerns ( e.g. , hangovers ) .
-RESULTS	These factors evidenced good internal consistency ( s = 0.76 to 0.86 ) .
-RESULTS	Higher scores on social reasons for limiting drinking were associated with lower typical quantity , maximum quantity , and binge frequency ( ps < 0.01 ) , and higher scores on lifestyle reasons were associated with lower maximum quantity , binge frequency , and intoxication frequency ( ps < 0.01 ) .
-RESULTS	In contrast , higher scores on impairment concerns were associated with more frequent drinking and intoxication , and higher risk of alcohol dependence ( ps < 0.05 ) , likely because dependent drinkers are more familiar with alcohol-induced impairment .
-CONCLUSIONS	The current study is the first to explore reasons for limiting drinking among individuals with HIV and how these reasons relate to alcohol involvement .
-CONCLUSIONS	This study yields a scale that can be used to assess reasons for limiting drinking among HIV-positive drinkers and provides information that can be used to enhance interventions with this population .
-CONCLUSIONS	Discussing social and lifestyle reasons for limiting drinking among less extreme drinkers may support and validate these patients ' efforts to limit engagement in heavy drinking ; discussion of impairment reasons for limiting drinking may be a way to engage dependent drinkers in efforts to decrease their alcohol consumption .
-
-###24273930
-BACKGROUND	Advanced type 2 diabetes mellitus ( T2DM ) needing insulin therapy is common .
-BACKGROUND	Most conventional anti-hyperglycemic drugs have limited efficacies and significant side effects , so that better anti-hyperglycemic agents are needed .
-BACKGROUND	Urtica dioica L. ( nettle ) leaves have insulin secretagogue , PPARgamma agonistic , and alpha-glucosidase inhibitory effects .
-BACKGROUND	Moreover , nettle leaves are used in traditional medicine as an anti-hyperglycemic agent to treat diabetes mellitus .
-BACKGROUND	Thus , efficacy and safety of nettle in the treatment of patients with advanced type 2 diabetes mellitus needing insulin were studied .
-METHODS	In this randomized double-blind placebo-controlled clinical trial , we evaluated the effects of taking nettle leaf extract ( one 500 mg capsule every 8 hours for 3 months ) combined with the conventional oral anti-hyperglycemic drugs on the blood levels of fasting glucose , postprandial glucose , glycosylated hemoglobin ( HbA1c ) , creatinine and liver enzymes SGOT and SGPT , and systolic and diastolic blood pressures in 46 patients and compared with the placebo group ( n = 46 ) .
-RESULTS	At the endpoint , the extract lowered the blood levels of fasting glucose , 2 hours postprandial glucose , and HbA1c significantly ( p < 0.001 , p = 0.009 , and p = 0.006 , respectively ) without any significant effects on the other parameters ( p > 0.05 ) compared with placebo .
-CONCLUSIONS	Nettle may safely improve glycemic control in type 2 diabetic patients needing insulin therapy .
-
-###25128002
-BACKGROUND	In women with mixed urinary incontinence , pelvic floor muscle training and solifenacin is the recommended conservative treatment , while electroacupuncture is a safe , economical and effective option .
-METHODS	In this prospective , multi-center , randomized controlled trial , five hundred women with mixed urinary incontinence , from 10 centers will be randomized to receive either electroacupuncture or pelvic floor muscle training plus solifenacin .
-METHODS	Women in the acupuncture group will receive electroacupuncture for 3 sessions per week , over 12 weeks , while women in the control group will receive pelvic floor muscle training plus solifenacin ( 5 mg once daily ) for 36 weeks .
-METHODS	The primary outcome measure is the proportion of change in 72-hour incontinence episode frequency from baseline to week 12 .
-METHODS	The secondary outcome measures include eleven items , including proportion of participants with 50 % decrease in average 72-h incontinence episode frequency , change from baseline in the amount of urine leakage and proportion of change from baseline in 72-h incontinence episode frequency in week 25-36 , and so forth .
-METHODS	Statistical analysis will include covariance analysis , nonparametric tests and t tests .
-CONCLUSIONS	The objective of this trial is to compare the efficacy and safety of electroacupuncture versus pelvic floor muscle training plus solifenacin in women with moderate and severe mixed urinary incontinence .
-BACKGROUND	ClinicalTrials.gov Identifier : NCT02047032 .
-
-###25376735
-BACKGROUND	In addition to their effects on bone health , high doses of cholecalciferol may have beneficial non-classic effects including the reduction of incidence of type 2 diabetes mellitus , cardiovascular disease , and cancer .
-BACKGROUND	These pleiotropic effects have been documented in observational and experimental studies or in small intervention trials .
-BACKGROUND	Vitamin D insufficiency is a frequent finding in renal transplant recipients ( RTRs ) , and this population is at risk of the previously cited complications .
-METHODS	The VITALE study is a prospective , multicentre , double-blind , randomized , controlled trial with two parallel groups that will include a total of 640 RTRs .
-METHODS	RTRs with vitamin D insufficiency , defined as circulating 25-hydroxyvitamin D levels of less than 30 ng/ml ( or 75 nmol/l ) , will be randomized between 12 and 48 months after transplantation to blinded groups to receive vitamin D3 ( cholecalciferol ) either at high or low dose ( respectively , 100,000 UI or 12,000 UI every 2 weeks for 2 months then monthly for 22 months ) with a follow-up of 2 years .
-METHODS	The primary objective of the study is to evaluate the benefit/risk ratio of high-dose versus low-dose cholecalciferol on a composite endpoint consisting of de novo diabetes mellitus ; major cardiovascular events ; de novo cancer ; and patient death .
-METHODS	Secondary endpoints will include blood pressure ( BP ) control ; echocardiography findings ; the incidences of infection and acute rejection episodes ; renal allograft function using estimated glomerular filtration rate ; proteinuria ; graft survival ; bone mineral density ; the incidence of fractures ; and biological relevant parameters of mineral metabolism .
-CONCLUSIONS	We previously reported that the intensive cholecalciferol treatment ( 100 000 IU every 2 weeks for 2 months ) was safe in RTR .
-CONCLUSIONS	Using a pharmacokinetic approach , we showed that cholecalciferol 100,000 IU monthly should maintain serum 25-hydroxyvitamin D at above 30 ng/ml but below 80 ng/ml after renal transplantation .
-CONCLUSIONS	Taken together , these results are reassuring regarding the safety of the cholecalciferol doses that will be used in the VITALE study .
-CONCLUSIONS	Analysis of data collected during the VITALE study will demonstrate whether high or low-dose cholecalciferol is beneficial in RTRs with vitamin D insufficiency .
-BACKGROUND	ClinicalTrials.gov Identifier : NCT01431430 .
-
-###25162362
-OBJECTIVE	The aim of the study was to evaluate the effectiveness and safety of 2 different polyethylene glycol ( PEG ) doses for the maintenance treatment of functional constipation in children .
-METHODS	Children with functional constipation according to the Rome III criteria were randomly assigned to receive PEG 4000 at a dose of either 0.7 g/kg ( high-dose group ; n = 45 ) or 0.3 g/kg ( low-dose group ; n = 47 ) for 6 weeks .
-METHODS	Adjustment of the therapy was recommended in the event of < 3 bowel movements ( BM ) per week or 3 BM per day .
-METHODS	The primary outcome measure was treatment success , defined as 3 BM per week with no fecal soiling during the last week of the intervention .
-RESULTS	A total of 90 of 92 randomized children , with a mean age of 3.72.1 years , completed the study .
-RESULTS	In the analysis based on allocated treatment , treatment success was similar in both groups ( relative risk 0.9 , 95 % confidence interval 0.78-1 .03 ) .
-RESULTS	Compared with the high-dose PEG group , the low-dose PEG group had an increased need for therapy adjustment of borderline significance ( relative risk 2.0 , 95 % confidence interval 1.0-4 .2 ) , an increased risk of painful defecation , a lower number of stools per week , and lower parental satisfaction .
-RESULTS	Adverse events were similar in both groups .
-CONCLUSIONS	To achieve treatment success , both tested doses of PEG were equally safe and effective in the treatment of children with functional constipation .
-
-###24310521
-OBJECTIVE	We sought to assess the prognostic role of collaterals in a large population of patients presenting with an acute coronary syndrome ( ACS ) .
-METHODS	The coronary collateral circulation was assessed by an independent angiographic core laboratory using the Rentrop Score in patients enrolled in the randomised Acute Catheterization and Urgent Intervention Triage Strategy trial .
-RESULTS	The cohort comprised 5412 patients with moderate to high risk ACS .
-RESULTS	A total of 858 patients ( 16.0 % ) had visible collaterals while 4554 patients ( 84.0 % ) had no collaterals .
-RESULTS	After multivariable adjustment , there were no differences in clinical outcomes at 1 year between the groups , including major adverse cardiac events ( MACE ) ( HR 0.94 ( 95 % CI 0.76 to 1.16 ) , p = 0.55 ) , mortality ( HR 1.03 ( 0.65 to 1.62 ) , p = 0.91 ) , myocardial infarction ( MI ) ( HR 1.07 ( 0.83 to 1.38 ) , p = 0.60 ) and unplanned target vessel revascularisation ( TVR ) ( HR 0.95 ( 0.71 to 1.28 ) , p = 0.75 ) .
-RESULTS	Similarly , in the subgroup of patients undergoing percutaneous coronary intervention ( PCI ) , the adjusted HR for major adverse cardiac events was 1.1 ( 0.76 to 1.61 ) , p = 0.595 ; 0.81 ( 0.10 to 6.44 ) , p = 0.999 for mortality ; and 0.86 ( 0.54 to 1.35 ) , p = 0.564 for MI .
-RESULTS	The risk of unplanned TVR was increased ( HR 2.74 ( 1.48 to 5.10 ) , p = 0.004 ) .
-CONCLUSIONS	In contrast to other studies , this large core laboratory-based analysis does not confirm a beneficial role of visible coronary collateral vessels on clinical outcomes in patients with ACS ; the presence of collaterals was even associated with increased mortality in the unadjusted analysis .
-CONCLUSIONS	Collaterals were associated with a higher risk of TVR in patients undergoing PCI , a finding that may not have been fully corrected given confounders and clinical differences between the groups .
-BACKGROUND	ClinicalTrials.gov Identifier : NCT00093158 .
-
-###24668250
-OBJECTIVE	The goal of this work was to evaluate the long-term efficacy of two dose-fractionation schedules for radiotherapy of calcaneodynia .
-METHODS	Between February 2006 and February 2010 , 457 evaluable patients were recruited for this prospective trial .
-METHODS	All patients received orthovoltage radiotherapy .
-METHODS	One course consisted of 6 fractions/3 weeks .
-METHODS	In case of insufficient remission of pain after 6 weeks a second series was performed .
-METHODS	Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy .
-METHODS	Endpoint was pain reduction .
-METHODS	Pain was measured before , right after ( early response ) , 6 weeks ( delayed response ) , and approximately 2.5 years after radiotherapy ( long-term response ) with a questionnaire-based visual analogue scale ( VAS ) and a comprehensive pain score ( CPS ) .
-RESULTS	The median follow-up was 32 months ( range 9-57 months ) .
-RESULTS	The overall early , delayed , and long-term response rates for all patients were 87 , 88 , and 95 % .
-RESULTS	The mean VAS values before treatment , for early , delayed , and long-term response for the 0.5 and 1.0 Gy groups were 65.522.1 and 64.020.5 ( p = 0.19 ) , 34.824.7 and 39.026.3 ( p = 0.12 ) , 25.126.8 and 28.926.8 ( p = 0.16 ) , and 16.324.3 and 14.119.7 ( p = 0.68 ) .
-RESULTS	The mean CPS values before treatment , for early , delayed , and log-term response were 10.12.7 and 10.03.0 ( p = 0.78 ) , 5.63.7 and 6.03.9 ( p = 0.34 ) , 4.04.1 and 4.33.6 ( p = 0.26 ) , and 2.13.3 and 2.33.2 ( p = 0.34 ) , respectively .
-RESULTS	No significant differences in long-term response quality between the two arms were found ( p = 0.50 ) .
-CONCLUSIONS	Radiotherapy is a very effective treatment for the management of benign calcaneodynia .
-CONCLUSIONS	For radiation protection reasons , the dose for a RT series should not exceed 3.0 Gy .
-
-###25650142
-OBJECTIVE	In the present study , we applied two incisionless suture techniques for otoplasty : Haytoglu et al. 's modification of incisionless otoplasty technique and Fritsch 's incisionless otoplasty technique for correction of prominent ears .
-METHODS	In this prospective study , 60 patients with prominent ears were included in the study .
-METHODS	In Group 1 , 55 ears of 30 patients ( 25 bilateral and 5 unilateral ) were operated with Haytoglu et al. 's modification of incisionless otoplasty technique .
-METHODS	In Group 2 , 57 ears of 30 patients ( 27 bilateral and 3 unilateral ) were operated with Fritsch 's incisionless otoplasty technique .
-METHODS	For comparison of two methods , auriculocephalic distances were measured at three levels which were level 1 ( the most superior point of the auricle ) , level 2 ( the midpoint of the auricle ) and level 3 ( level of the lobule ) pre-operatively ( preop ) ; and measurements were repeated at the end of the surgery ( PO ( 0-day ) ) , 1st month ( PO ( 1-Mo ) ) and 6th month ( PO ( 6-Mo ) ) after the surgery , in both groups .
-METHODS	Patient satisfaction was evaluated using a visual analog scale ( VAS ) .
-METHODS	Moreover , Global Aesthetic Improvement Scale ( GAIS ) was rated by an independent , non-participating plastic surgeon at 6 months after the surgery .
-RESULTS	Operation time was 15.95.6 min in Group 1 ( Haytoglu et al. 's ) and 194.7 min in Group 2 ( Fritsch ) .
-RESULTS	Hematoma , infection , bleeding , keloid scar formation , sharp edges or irregularities of the cartilage were not observed in any group .
-RESULTS	Suture extrusion was detected in 14.03 % of Group 1 and 16.1 % of Group 2 .
-RESULTS	No statistically significant difference was observed between auriculocephalic distances at levels 1-3 of groups at preop , PO ( 0-day ) , PO ( 1-Mo ) and PO ( 6-Mo ) separately .
-RESULTS	Similarly , difference in auriculocephalic distances ( preop values-PO ( 6-Mo ) values ) was not detected as statistically significant in Groups 1 and 2 at three levels .
-RESULTS	In both techniques , No statistically significant difference was observed in patient satisfaction at 6th months after the operation which was measured using Visual Analogue Scale ( VAS ) on 0 to 100 scales .
-RESULTS	According to GAIS , the patients were rated as 92.9 % `` improved '' and 7.1 % `` no change '' in Group 1 ; as 94.6 % `` improved '' and 5.4 % `` no change '' in Group 2 .
-CONCLUSIONS	Due to the similar results , Haytoglu et al. 's and Fritsch 's incisionless otoplasty techniques are good options in the treatment of prominent ears , especially in pediatric patients with isolated inadequate development of antihelical ridge , and with soft auricular cartilage .
-
-###26152838
-OBJECTIVE	Determine if oral treatment with a vasoconstrictor decreases the blood to middle ear exchange rate of the perfusion-limited gas , nitrous oxide ( N2O ) .
-METHODS	Randomized , double-blind , crossover study .
-METHODS	Ten adult subjects with and 10 without past middle ear disease completed paired experimental sessions , identical except for oral treatment with either pseudoephedrine hydrochloride or lactose placebo .
-METHODS	At each session , subjects were fitted with a nonrebreathing mask and breathed room air for 20 minutes ( acclimation period ) , 50 % N2O :50 % O2 for 20 minutes ( experimental period ) , and 100 % O2 for 10 minutes ( recovery period ) .
-METHODS	Throughout , heart rate , blood pressure , and O2 saturation were monitored , and bilateral middle ear pressures were recorded by tympanometry every minute .
-METHODS	The primary outcome was the slope of the middle ear pressure-time function for the experimental period , which estimates the volume N2O exchange rate .
-METHODS	Using repeated measures analysis of variance , the effects of group ( disease history ) , treatment ( active vs. placebo ) , and period ( 1 vs. 2 ) on the recorded vital signs , and of group , treatment , and ear ( left/right ) on the middle ear pressure-time slope were evaluated for statistical significance .
-RESULTS	Statistically significant effects of period on O2 saturation ( period 2 > period 1 ) and of treatment on heart rate ( active > placebo ) were documented .
-RESULTS	Only treatment was statistically significant for the middle ear pressure-time slope , with a shallower slope characterizing the active treatment session .
-CONCLUSIONS	The volume exchange rate across the middle ear mucosa of perfusion-limited gases can be modulated pharmacologically .
-CONCLUSIONS	Theoretically , similar drugs can be used to reduce the requisite eustachian tube opening efficiency for adequate middle ear pressure regulation .
-METHODS	1b .
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-###24393548
-OBJECTIVE	Pain attitudes and beliefs are hypothesized to influence pain and adjustment to pain .
-OBJECTIVE	Valid and reliable measures of these beliefs are necessary to test their hypothesized associations with outcomes .
-OBJECTIVE	The Pediatric version of the Survey of Pain Attitudes ( Peds-SOPA ) is a new measure with limited evidence regarding its psychometric properties .
-OBJECTIVE	This study sought to : 1 ) evaluate the predictive validity , reliability , and factor structure of the Peds-SOPA ; and 2 ) determine if there are sex - or age-related differences in children 's attitudes toward pain .
-METHODS	Longitudinal study .
-METHODS	Five hundred and sixty-one schoolchildren between 8 and 16 years old participated in this study .
-RESULTS	Factor analyses supported the seven-factor structure described by the original authors .
-RESULTS	The Peds-SOPA showed acceptable reliability with Cronbach alpha values ranging from 0.68 to 0.80 .
-RESULTS	The Peds-SOPA scales also demonstrated prospective predictive validity via their associations with pain intensity , and pain status at 1-year follow-up .
-RESULTS	The findings also showed some few sex - and age-specific differences in the Peds-SOPA scores .
-CONCLUSIONS	The current findings provide additional support for the reliability and validity of the Peds-SOPA , and suggest that children 's pain attitudes and beliefs might be important intervention targets in pain treatment .
-
-###25993609
-BACKGROUND	This is the third study in a Phase 3 program evaluating onabotulinumtoxinA treatment of crow 's feet lines ( CFL ) .
-OBJECTIVE	To assess the efficacy and safety of repeated onabotulinumtoxinA treatments of CFL alone or with glabellar lines ( GL ) in subjects with moderate-to-severe CFL and GL ( maximum smile ) .
-METHODS	This 5-month extension of a 7-month study randomized subjects who originally received onabotulinumtoxinA 24 U ( CFL only ; n = 227 ) or 44 U ( 24 U for CFL + 20 U for GL ; n = 260 ) to retreatment with the same dose .
-METHODS	Placebo-treated subjects were rerandomized to onabotulinumtoxinA 44 U ( n = 101 ) or placebo ( n = 96 ) .
-METHODS	Primary efficacy end point ( Day 30 ) was the proportion of subjects who achieved a CFL severity rating of none or mild ( maximum smile ) on the investigator-assessed Facial Wrinkle Scale ( FWS ) .
-METHODS	Additional efficacy end points and adverse events were evaluated .
-RESULTS	Responder rates ( primary end point ) were significantly greater in onabotulinumtoxinA-treated groups ( 24 U : 56.5 % ; 44 U : 63.6 % ; placebo : 1.1 % ; p < .001 ) .
-RESULTS	Improvements on most patient-reported outcomes ( PROs ) favored the 44-U group over the 24-U group .
-RESULTS	Adverse events did not differ among groups ; most were mild or moderate .
-CONCLUSIONS	Repeated onabotulinumtoxinA treatments significantly reduce CFL severity based on FWS and PROs .
-CONCLUSIONS	Adverse event profiles remain consistent with approved GL labeling .
-
-###25831464
-BACKGROUND	Few randomized clinical trials have investigated antiretroviral regimens in very advanced HIV-1-infected patients .
-BACKGROUND	The objective was to study the immune reconstitution in very immunosuppressed antiretroviral-naive , HIV-1-infected individuals by comparing an efavirenz-based regimen with 2 ritonavir-boosted protease inhibitor regimens .
-METHODS	Randomized , controlled , open-label , multicenter clinical trial .
-METHODS	Eighty-nine HIV-1-infected antiretroviral-naive patients with < 100 CD4 cells per cubic millimeter were randomly assigned in a 1:1:1 ratio to efavirenz ( n = 29 ) , atazanavir/ritonavir ( n = 30 ) , or lopinavir/ritonavir ( n = 30 ) combined with tenofovir plus emtricitabine .
-METHODS	The primary outcome was median increase in CD4 cell count at week 48 .
-METHODS	Secondary end points were the proportion of patients with HIV-1 RNA < 50 copies per milliliter , adverse events , disease progression , and death .
-RESULTS	In the on-treatment analysis , the median ( interquartile range ) increase in the CD4 count after 48 weeks was +193 ( 129-349 ) cells per microliter in the efavirenz arm , +197 ( 146-238 ) cells per microliter in the ritonavir-boosted atazanavir arm , and +205 ( 178-327 ) cells per microliter in the ritonavir-boosted lopinavir arm ( P = 0.73 ) .
-RESULTS	The percentage of patients achieving viral suppression was similar in all 3 treatment arms at 48 weeks { efavirenz , 85.71 % [ 95 % confidence interval ( CI ) : 68.5 to 94.3 ] ; atazanavir , 80 % [ 95 % CI : 62.7 to 90.5 ] ; and lopinavir , 82.8 % [ 95 % CI : 65.5 to 92.4 ] ; P = 0.88 } .
-RESULTS	Bacterial translocation , inflammation , immune activation , and apoptotic markers , but not D-dimer , declined significantly and similarly in the 3 treatment arms .
-RESULTS	Adverse events had a similar incidence in all 3 antiretroviral regimens .
-RESULTS	No patients died .
-CONCLUSIONS	The immune reconstitution induced by an efavirenz-based regimen in very advanced HIV-1-infected patients was similar to that induced by a ritonavir-boosted protease inhibitor-based regimen ( ClinicalTrials.gov registration number : NCT00532168 ) .
-
-###26156651
-BACKGROUND	There is a major unmet need for effective treatments in patients with squamous cell carcinoma of the lung .
-BACKGROUND	LUX-Lung 8 compared afatinib ( an irreversible ErbB family blocker ) with erlotinib ( a reversible EGFR tyrosine kinase inhibitor ) , as second-line treatment for patients with advanced squamous cell carcinoma of the lung .
-METHODS	We did this open-label , phase 3 randomised controlled trial at 183 cancer centres in 23 countries worldwide .
-METHODS	We enrolled adults with stage IIIB or IV squamous cell carcinoma of the lung who had progressed after at least four cycles of platinum-based-chemotherapy .
-METHODS	Participants were randomly assigned ( 1:1 ) to receive afatinib ( 40 mg per day ) or erlotinib ( 150 mg per day ) until disease progression .
-METHODS	The randomisation was done centrally with an interactive voice or web-based response system and stratified by ethnic origin ( eastern Asian vs non-eastern Asian ) .
-METHODS	Clinicians and patients were not masked to treatment allocation .
-METHODS	The primary endpoint was progression-free survival assessed by independent central review ( intention-to-treat population ) .
-METHODS	The key secondary endpoint was overall survival .
-METHODS	This trial is registered with ClinicalTrials.gov , NCT01523587 .
-RESULTS	795 eligible patients were randomly assigned ( 398 to afatinib , 397 to erlotinib ) .
-RESULTS	Median follow-up at the time of the primary analysis of progression-free survival was 67 months ( IQR 31-102 ) , at which point enrolment was not complete .
-RESULTS	Progression free-survival at the primary analysis was significantly longer with afatinib than with erlotinib ( median 24 months [ 95 % CI 19-29 ] vs 19 months [ 19-22 ] ; hazard ratio [ HR ] 082 [ 95 % CI 068-100 ] , p = 00427 ) .
-RESULTS	At the time of the primary analysis of overall survival ( median follow-up 184 months [ IQR 138-224 ] ) , overall survival was significantly greater in the afatinib group than in the erloinib group ( median 79 months [ 95 % CI 72-87 ] vs 68 months [ 59-78 ] ; HR 081 [ 95 % CI 069-095 ] , p = 00077 ) , as were progression-free survival ( median 26 months [ 95 % CI 20-29 ] vs 19 months [ 19-21 ] ; HR 081 [ 95 % CI 069-096 ] , p = 00103 ) and disease control ( 201 [ 51 % ] of 398 patients vs 157 [ 40 % ] of 397 ; p = 00020 ) .
-RESULTS	The proportion of patients with an objective response did not differ significantly between groups ( 22 [ 6 % ] vs 11 [ 3 % ] ; p = 00551 ) .
-RESULTS	Tumour shrinkage occurred in 103 ( 26 % ) of 398 patients versus 90 ( 23 % ) of 397 patients .
-RESULTS	Adverse event profiles were similar in each group : 224 ( 57 % ) of 392 patients in the afatinib group versus 227 ( 57 % ) of 395 in the erlotinib group had grade 3 or higher adverse events .
-RESULTS	We recorded higher incidences of treatment-related grade 3 diarrhoea with afatinib ( 39 [ 10 % ] vs nine [ 2 % ] ) , of grade 3 stomatitis with afatinib ( 16 [ 4 % ] vs none ) , and of grade 3 rash or acne with erlotinib ( 23 [ 6 % ] vs 41 [ 10 % ] ) .
-CONCLUSIONS	The significant improvements in progression-free survival and overall survival with afatinib compared with erlotinib , along with a manageable safety profile and the convenience of oral administration suggest that afatinib could be an additional option for the treatment of patients with squamous cell carcinoma of the lung .
-BACKGROUND	Boehringer Ingelheim .
-
-###24761456
-OBJECTIVE	Physicians adopt evidence-based guidelines with variable consistency .
-OBJECTIVE	Narratives , or stories , offer a novel dissemination strategy for clinical recommendations .
-OBJECTIVE	The study objective was to compare whether evidence-based narrative versus traditional summary improved recall of opioid prescribing guidelines from the American College of Emergency Physicians ( ACEP ) .
-METHODS	This was a prospective , randomized controlled experiment to compare whether narrative versus summary promoted short-term recall of six themes contained in the ACEP opioid guideline .
-METHODS	The experiment was modeled after the free-recall test , an established technique in studies of memory .
-METHODS	At a regional conference , emergency physicians ( EPs ) were randomized to read either a summary of the guideline ( control ) or a narrative ( intervention ) .
-METHODS	The fictional narrative was constructed to match the summary in content and length .
-METHODS	One hour after reading the text , participants listed all content that they could recall .
-METHODS	Two reviewers independently scored the responses to assess recall of the six themes .
-METHODS	The primary outcome was the total number of themes recalled per participant .
-METHODS	Secondary outcomes included the proportion of responses in each study arm that recalled individual themes and the proportion of responses in each arm that contained falsely recalled or extraneous information .
-RESULTS	Ninety-five physicians were randomized .
-RESULTS	Eighty-two physicians completed the experiment , for a response rate of 86 % .
-RESULTS	The mean of the total number of themes recalled per participant was 3.1 in the narrative arm versus 2.0 in the summary arm ( difference = 1.1 , 95 % confidence interval [ CI ] = 0.6 to 1.7 ) .
-RESULTS	For three themes , the proportion of responses that recalled the theme was significantly greater in the narrative arm compared to the summary arm , with the differences ranging from 20 % to 51 % .
-RESULTS	For one theme , recall was significantly greater in the summary arm .
-RESULTS	For two themes , there was no statistically significant difference in recall between the arms .
-RESULTS	In the summary arm , 54 % of responses were found to contain falsely recalled or extraneous information versus 21 % of responses in the narrative arm ( difference = 33 % , 95 % CI = 14 % to 53 % ) .
-CONCLUSIONS	Physicians exposed to a narrative about opioid guidelines were more likely to recall guideline content at 1 hour than those exposed to a summary of the guidelines .
-CONCLUSIONS	Future studies should examine whether the incorporation of narratives in dissemination campaigns improves guideline adoption and changes clinical practice
-
-###24237188
-OBJECTIVE	Paullinia cupana ( guaran ) is an Amazonian plant that has been previously shown to be effective in treating chemotherapy-related fatigue ( CRF ) in patients with breast cancer .
-OBJECTIVE	We aimed to evaluate the efficacy of a purified dry extract of P. cupana ( PC-18 ) in patients with various solid tumors treated with chemotherapy .
-METHODS	We included 40 patients with solid tumors who showed increases in their Brief Fatigue Inventory ( BFI ) questionnaire scores after 1 week of systemic chemotherapy .
-METHODS	PC-18 was administered at 37.5 mg by mouth two times per day ( PO bid ) , starting after 1 week of chemotherapy , for 3 weeks ( induction phase ) .
-METHODS	Patients who had an improvement in or stabilization of their BFI scores were randomized to receive either PC-18 at the same dose or placebo for the following 3 weeks ( maintenance phase ) .
-RESULTS	After PC-18 treatment , the BFI fatigue scores improved or stabilized in 36 out of the 40 patients ( mean BFI score difference = 2.503 ; 95 % confidence interval : 1.716-3 .375 , p = .0002 ) .
-RESULTS	Three weeks after randomization ( 16 patients on PC-18 and 17 on placebo ) , we observed no significant differences in the BFI , Functional Assessment of Chronic Illness Therapy , Hospital Anxiety and Depression Scale , and Pittsburgh Sleep Quality Index scores between patients randomized to PC-18 versus placebo .
-CONCLUSIONS	We conclude that the PC-18 extract may be effective for the treatment of CRF in patients with a variety of solid tumors .
-CONCLUSIONS	A conditioning effect , which was observed in patients who had a beneficial effect of PC-18 on CRF , may explain the better than expected fatigue scores of the placebo-treated patients .
-
-###24527503
-BACKGROUND	A single session of left prefrontal rTMS has been shown to have analgesic effects , and to reduce post-operative morphine use .
-BACKGROUND	We sought to test these findings in a larger sample , and try and see if multiple sessions had additive analgesic benefit .
-METHODS	108 patients undergoing laparoscopic gastric bypass surgery received two sessions of 10 Hz rTMS ( 110 % of motor threshold ) over the left dorsolateral prefrontal cortex ( one immediately following surgery and one 4 h later ) .
-METHODS	Participants were randomly assigned to receive 2 sessions of real rTMS , 2 sessions of sham , 1 real then 1 sham , or 1 sham then 1 real rTMS treatments .
-METHODS	Patients and study staff were blind to rTMS conditions .
-RESULTS	Unlike previous rTMS trials for post-operative pain , no differences emerged between groups with respect to total patient-controlled analgesia usage ( IV hydromorphone ) .
-RESULTS	However , despite no difference in IV analgesic usage , subjects that received 2 real rTMS sessions rated both the affective and sensory dimensions of their pain significantly lower than those in the shamsham group at several time points during the post-surgical/post-rTMS period .
-CONCLUSIONS	This study suggests that left prefrontal rTMS may produce significant analgesic effects in the perioperative setting .
-CONCLUSIONS	However , further work is needed to understand this effect and attempt to make it clinically useful in light of the lack of effect on PCA hydromorphone use .
-
-###25565482
-OBJECTIVE	Increasing physical activity is an important public-health goal worldwide , but there are few published mediation analyses of physical-activity interventions in low-to-middle-income countries like South Africa undergoing a health transition involving markedly increased mortality from non-communicable diseases .
-OBJECTIVE	This article reports secondary analyses on the mediation of a theory-of-planned-behavior-based behavioral intervention that increased self-reported physical activity in a trial with 1181 men in Eastern Cape Province , South Africa .
-METHODS	Twenty-two matched-pairs of neighborhoods were randomly selected .
-METHODS	Within pairs , neighborhoods were randomized to a health-promotion intervention or an attention-matched control intervention with baseline , immediate-post , and 6 - and 12-month post-intervention assessments .
-METHODS	Theory-of-planned-behavior constructs measured immediately post-intervention were tested as potential mediators of the primary outcome , self-reported physical activity averaged over the 6 - and 12-month post-intervention assessments , using a product-of-coefficients approach in a generalized-estimating-equations framework .
-METHODS	Data were collected in 2007-2010 .
-RESULTS	Attitude , subjective norm , self-efficacy , and intention were significant mediators of intervention-induced increases in self-reported physical activity .
-RESULTS	The descriptive norm , not affected by the intervention , was not a mediator , but predicted increased self-reported physical activity .
-CONCLUSIONS	The results suggest that interventions targeting theory-of-planned-behavior constructs may contribute to efforts to increase physical activity to reduce the burden of non-communicable diseases among South African men .
-
-###25790673
-OBJECTIVE	To observe the intervention effect of nourishing Xin and Shen method ( NXSM ) on the cognitive function of mild cognitive impairment due to subcortical small vessel disease ( MCI-SSVD ) .
-METHODS	All 54 MCI-SSVD patients came from Department of Traditional Chinese Medicine , Affiliated Union Hospital of Fujian Medical University from June 2010 to August 2013 .
-METHODS	They were randomly assigned to the treatment group ( 28 cases ) and the control group ( 26 cases ) .
-METHODS	Another 33 volunteers were recruited as a healthy control group .
-METHODS	On the basis of targeting risk factors of blood vessels , MCI-SSVD patients were treated respectively with NXSM and donepezil hydrochloride , with the therapeutic course of 12 weeks .
-METHODS	Neuropsychological scales [ mini-mental state examination ( MMSE ) and Montreal cognitive assessment ( MoCA ) ] , and Chinese medical dementia syndrome scales were performed in all subjects , and results were compared among groups or intra-group before and after treatment .
-RESULTS	MMSE and MoCA scores of the two treatment groups decreased more , when compared with those of the healthy control group ( P < 0.05 ) .
-RESULTS	In particular , MoCA score was significantly decreased ( P < 0.01 ) .
-RESULTS	MMSE and MoCA scores of the two treatment groups increased more after treatment than before treatment ( P < 0.05 ) .
-RESULTS	But there was no statistical difference in MMSE or MOCA score after treatment between the two groups ( P > 0.05 ) .
-RESULTS	Chinese medical dementia syndrome scales decreased more significantly in the treatment group , when compared with before treatment ( P < 0.01 ) .
-RESULTS	But there was no statistical difference in Chinese medical dementia syndrome scales in the control group between before and after treatment ( P > 0.05 ) .
-RESULTS	Visual spatial and executive function scores or delayed recall scores of the two treatment groups increased more , when compared with the same group before treatment ( P < 0.05 , P < 0.01 ) .
-CONCLUSIONS	NXSM could effectively improve cognitive functions of MCI-SSVD .
-
-###25675562
-OBJECTIVE	To optimize the therapeutic programs for periarthritis of shoulder treated with acupuncture , moxibustion and kinetohterapy with orthogonal design method adopted .
-METHODS	The orthogonal design table of L8 ( 2 ( 7 ) ) hierarchical principle was used to randomly divide 192 patients of periarthritis of shoulder into 8 groups , 24 cases in each one .
-METHODS	Separately , 4 factors and each different 2 levels were adopted in treatment , named acupuncture timing ( factor A : A , acute stage , A2 adhesion stage ) , acupoint combination ( factor B : B , local acupoints , B2 local acupoints and distal acupoints along meridians ) , filiform needling and warm needling therapy ( factor C : C1 acupuncture with filiform needle , CZ acupuncture with filiform needle and warm needling therapy ) and positive functional exercise ( factor D : D1 without positive functional exercise , D2 with positive functional exercise ) .
-METHODS	The treatment was given once a day , 10 treatments made one session and 2 sessions were required totally .
-METHODS	The time points of observation were the point after 1 session of treatment and after 2 sessions of treatment .
-METHODS	The short-form McGill pain questionnaire ( MPQ ) and shoulder joint motor disturbance score were adopted for evaluation .
-RESULTS	In the orthogonal design analysis , taking the hierarchical factors into consideration , the age was considered as the main factor in the evaluation of shoulder pain and shoulder motor disturbance ( P < 0.01 ) , and the shoulder function grade apparently impacted pain evaluation and the efficacy on shoulder motor disturbance ( P < 0.01 ) .
-RESULTS	The best combination of 4 factors and 2 levels were A1B1CzD2 and A2 BC2D2 .
-RESULTS	SAS statistical analysis showed that at acute stage and adhesion stage , CZ Dz , meaning acupuncture with fifiform needling and warm needling therapy combined with positive functional exercise , is the main factor of the improvements of shoulder motor function ( P < 0.05 ) .
-CONCLUSIONS	For periarthritis of shoulder at acute stage , the combined therapy of acupuncture at local acupoints , warm needling and positive functional exercise is adopted .
-CONCLUSIONS	At chronic stage , the combined therapy of acupuncture at local acupoints and distal acupoints , acupuncture with filiform needle and warm needling and positive functional exercise is the best program .
-CONCLUSIONS	Additionally , in clinical treatment , the patients ' age , sex , shoulder joint function and duration of treatment should be considered comprehensively for the impacts on the efficacy .
-
-###25407349
-BACKGROUND	Inappropriate drug use has been identified as one of the most important problems affecting the quality of care in older people .
-BACKGROUND	Inappropriate drug use may increase the risk of the occurrence of ` geriatric giants ' such as immobility , instability , incontinence and cognitive impairment .
-BACKGROUND	There are indications that clinical medication reviews ( CMR ) can reduce inappropriate drug use .
-BACKGROUND	However , CMRs have not yet been implemented at a large scale in primary care .
-BACKGROUND	An innovative medication review program in primary care will be developed which tackles the most important obstacles for a large scale implementation of CMRs .
-BACKGROUND	The aim of this study is to assess whether this CMR program is ( cost - ) effective compared with usual general practice care for older patients with geriatric symptoms with regard to quality of life and geriatric symptoms .
-METHODS	A cluster randomised controlled trial will be performed in 20 Dutch general practices including 500 patients .
-METHODS	Patients of 65years and older are eligible if they newly present with pre-specified geriatric symptoms in general practice and chronic use of at least one prescribed drug .
-METHODS	GP practices will be stratified by practice size and randomly allocated to control ( n = 10 ) or intervention group ( n = 10 ) .
-METHODS	The intervention consists of CMRs which will be facilitated and prepared by an expert team consisting of a GP and a pharmacist .
-METHODS	Primary outcome measures are patient 's quality of life and the presence of self-reported geriatric symptoms during a follow-up period of 6months .
-METHODS	Secondary outcomes are costs of healthcare utilisation , feasibility , number of drug related problems , medication adherence and satisfaction with medication .
-CONCLUSIONS	This study is expected to add evidence on the ( cost - ) effectiveness of an optimally facilitated , prepared and structured CMR in comparison with usual care in older patients who present a geriatric symptom to their GP .
-CONCLUSIONS	The strength of this study is that it will be conducted in daily clinical practice .
-CONCLUSIONS	This improves the possibilities to implement the CMRs in the primary care setting on a large scale .
-BACKGROUND	Netherlands Trial register : NTR4264 .
-
-###24973836
-OBJECTIVE	To evaluate the safety and efficacy of various initial strategies of loop diuretic administration in patients with acute decompensated heart failure ( ADHF ) on diuresis , renal function , electrolyte balance and clinical outcomes .
-METHODS	Consecutive patients admitted with ADHF were randomized into three groups - intravenous furosemide infusion + intravenous dopamine , intravenous furosemide bolus in two divided doses and intravenous furosemide continuous infusion alone .
-METHODS	At 48h , the treating physician could adjust the diuretic strategy .
-METHODS	Primary endpoint was negative fluid balance at 24h after admission .
-METHODS	Secondary end points were duration of hospital stay , negative fluid balance at 48 , 72 , 96h , the trend of serum electrolytes , and renal function and 30 day clinical outcome ( death and emergency department visits ) .
-RESULTS	Overall ninety patients ( thirty in each group ) were included in the study .
-RESULTS	There was a greater diuresis in first 24h ( p = 0.002 ) and a shorter hospital stay ( p = 0.023 ) with the bolus group .
-RESULTS	There was no significant difference in renal function and serum sodium and serum potassium levels .
-RESULTS	There was no difference in the number of emergency department visits among the three groups .
-CONCLUSIONS	All three modes of diuretic therapies can be practiced with no difference in worsening of renal function and electrolyte levels .
-CONCLUSIONS	Bolus dose administration with itsrapid volume loss and shorter hospital stay might be a more effective diuretic strategy .
-
-###24932893
-BACKGROUND	Missed scheduled HIV appointments lead to increased mortality , resistance to antiretroviral therapy , and suboptimum virological response .
-BACKGROUND	We aimed to assess whether reminders sent to carers by text message , mobile phone call , or concomitant text message and mobile phone call increase attendance at medical appointments for HIV care in a population of children infected with or exposed to HIV in Cameroon .
-BACKGROUND	We also aimed to ascertain the most cost-effective method of mobile-phone-based reminder .
-METHODS	MORE CARE was a multicentre , single-blind , factorial , randomised controlled trial in urban , semi-urban , and rural settings in Cameroon .
-METHODS	Carers of children who were infected with or had been exposed to HIV were randomly assigned electronically in blocks of four and allocated ( 1:1:1:1 ) sequentially to receive a text message and a call , a text message only , a call only , or no reminder ( control ) .
-METHODS	Investigators were masked to group assignment .
-METHODS	Text messages were sent and calls made 2 or 3 days before a scheduled follow-up appointment .
-METHODS	The primary outcomes were efficacy ( the proportion of patients attending a previously scheduled appointment ) and efficiency ( attendance / [ measures of staff working time cost of the reminders ] ) , as a measure of cost-effectiveness .
-METHODS	The primary analysis was by intention to treat .
-METHODS	This study is registered with the Pan African Clinical Trials Register , number PACTR201304000528276 .
-RESULTS	The study took place between Jan 28 and May 24 , 2013 .
-RESULTS	We randomly assigned 242 adult-child ( carer-patient ) pairs into four groups : text message plus call ( n = 61 ) , call ( n = 60 ) , text message ( n = 60 ) , and control ( n = 61 ) .
-RESULTS	54 participants ( 89 % ) in the text message plus call group , 51 ( 85 % ) in the call group , 45 ( 75 % ) in the text message group , and 31 ( 51 % ) in the control group attended their scheduled appointment .
-RESULTS	Compared with control , the odds ratios for improvement in the primary efficacy outcome were 75 ( 95 % CI 29-190 ; p < 00001 ) for text message plus call , 55 ( 23-131 ; p = 00002 ) for call , and 29 ( 13-63 ; p = 0012 ) for text message .
-RESULTS	No significant differences were seen in comparisons of the three intervention groups with each other , and there was no synergism between text messages and calls .
-RESULTS	For the primary efficiency outcome , the mean difference for text message versus text message plus call was 15 ( 95 % CI 07 to 24 ; p = 0002 ) , for call versus text message plus call was 12 ( 07 to 16 ; p < 00001 ) , and for call versus text message was 04 ( -13 to 06 ; p = 047 ) .
-CONCLUSIONS	Mobile-phone-based reminders of scheduled HIV appointments for carers of paediatric patients in low-resource settings can increase attendance .
-CONCLUSIONS	The most effective method of reminder was text message plus phone call , but text messaging alone was the most efficient ( ie , cost-effective ) method .
-BACKGROUND	No external funding .
-
-###26017658
-BACKGROUND	Safe and cost-effective programs for implementing early infant male circumcision ( EIMC ) in Africa need to be piloted .
-BACKGROUND	We present results on a relative cost analysis within a randomized noninferiority trial of EIMC comparing the AccuCirc device with Mogen clamp in Zimbabwe .
-METHODS	Between January and June 2013 , male infants who met inclusion criteria were randomized to EIMC through either AccuCirc or Mogen clamp conducted by a doctor , using a 2:1 allocation ratio .
-METHODS	We evaluated the overall unit cost plus the key cost drivers of EIMC using both AccuCirc and Mogen clamp .
-METHODS	Direct costs included consumable and nonconsumable supplies , device , personnel , associated staff training , and environmental costs .
-METHODS	Indirect costs comprised capital and support personnel costs .
-METHODS	In 1-way sensitivity analyses , we assessed potential changes in unit costs due to variations in main parameters , one at a time , holding all other values constant .
-RESULTS	The unit costs of EIMC using AccuCirc and Mogen clamp were $ 49.53 and $ 55.93 , respectively .
-RESULTS	Key cost drivers were consumable supplies , capacity utilization , personnel costs , and device price .
-RESULTS	Unit prices are likely to be lowest at full capacity utilization and increase as capacity utilization decreases .
-RESULTS	Unit prices also fall with lower personnel salaries and increase with higher device prices .
-CONCLUSIONS	EIMC has a lower unit cost when using AccuCirc compared with Mogen clamp .
-CONCLUSIONS	To minimize unit costs , countries planning to scale-up EIMC using AccuCirc need to control costs of consumables and personnel .
-CONCLUSIONS	There is also need to negotiate a reasonable device price and maximize capacity utilization .
-
-###24471786
-BACKGROUND	A number of perioperative risk factors may suppress the immune system and contribute to the development of post-operative complications .
-BACKGROUND	The association between surgical site infection ( SSI ) and other wound-related complications resulting from immunosuppression through either perioperative administration of dexamethasone , pre-operative smoking or alcohol abuse is , however , uncertain .
-METHODS	This study was a post hoc analysis of data from the PROXI randomized trial in 1386 patients who underwent emergency or elective laparotomy .
-METHODS	We assessed the associations of use of dexamethasone , smoking status and alcohol abuse with the primary outcome , being a composite of SSI , anastomotic leak , wound dehiscence , burst abdomen and 30-day mortality .
-RESULTS	The primary outcome occurred in 21 % of patients receiving dexamethasone versus 28 % of patients not receiving dexamethasone , and this was not statistically significant when adjusting for stratification variables originally used in the PROXI trial [ OR 0.90 , 95 % CI ( 0.65-1 .24 ) ] .
-RESULTS	In smokers , the primary outcome occurred in 32 % , compared with 23 % of non-smokers ( P = 0.0001 ) .
-RESULTS	Smokers also had a higher frequency of SSI ( 25 % vs 17 % , P < 0.0001 ) and burst abdomen ( 3.8 % vs 2.4 % , P = 0.04 ) .
-RESULTS	In alcohol abusers , the primary outcome occurred in 48 % , compared with 25 % in patients who did not abuse alcohol ( P = 0.0006 ) .
-RESULTS	Burst abdomen occurred more commonly in alcohol abusers ( 15 % vs 2.3 % , P < 0.0001 ) .
-CONCLUSIONS	Perioperative administration of dexamethasone was not significantly associated with SSI or other wound-related complications .
-CONCLUSIONS	Conversely , smoking and alcohol abuse were both significant predictors of the primary outcome consisting of wound-related complications and mortality .
-
-###25481453
-BACKGROUND	While research suggests primary prescription opioid ( PO ) abusers may exhibit less severe demographic and drug use characteristics than primary heroin abusers , less is known about whether a lifetime history of heroin use confers greater severity among PO abusers .
-OBJECTIVE	In this secondary analysis , we examined demographic and drug use characteristics as a function of lifetime heroin use among 89 PO-dependent adults screened for a trial evaluating the relative efficacy of buprenorphine taper durations .
-OBJECTIVE	Exploratory analyses also examined contribution of lifetime heroin use to treatment response among a subset of participants who received a uniform set of study procedures .
-METHODS	Baseline characteristics were compared between participants reporting lifetime heroin use 5 ( H ( + ) ; n = 41 ) vs. < 5 ( H ( - ) ; n = 48 ) times .
-METHODS	Treatment response ( i.e. , illicit opioid abstinence and treatment retention at end of study ) was examined in the subset of H ( + ) and H ( - ) participants randomized to receive the 4-week taper condition ( N = 22 ) .
-RESULTS	H ( + ) participants were significantly older and more likely to be male .
-RESULTS	They reported longer durations of illicit opioid use , greater alcohol-related problems , more past-month cocaine use , greater lifetime IV drug use , and greater lifetime use of cigarettes , amphetamines and hallucinogens .
-RESULTS	H ( + ) participants also had lower scores on the Positive Symptom Distress and Depression subscales of the Brief Symptom Inventory .
-RESULTS	Finally , there was a trend toward poorer treatment outcomes among H ( + ) participants .
-CONCLUSIONS	A lifetime history of heroin use may be associated with elevated drug severity and unique treatment needs among treatment-seeking PO abusers .
-
-###24830824
-OBJECTIVE	To evaluate the onset and duration of improvement in best-corrected visual acuity ( BCVA ) in eyes treated with dexamethasone intravitreal implant 0.7 mg ( DEX implant ) for macular edema after branch or central retinal vein occlusion .
-METHODS	Post hoc analysis of data from 2 previously reported multicenter , 6-month , randomized sham-controlled clinical trials .
-METHODS	Patients received a single DEX implant ( n = 427 ) or sham procedure ( n = 426 ) in the study eye .
-METHODS	The primary endpoint was the percentage of eyes with 15-letter improvement in BCVA from baseline at postimplant Day 7 .
-RESULTS	The baseline mean BCVA was 20/80 .
-RESULTS	At Day 7 , 10.3 % of DEX implant-treated eyes versus 4.0 % of sham-treated eyes ( P < 0.001 ) had 15-letter improvement in the BCVA , and 27.2 % of DEX implant-treated eyes versus 10.6 % of sham-treated eyes had 10-letter improvement ( P < 0.001 ) .
-RESULTS	The mean improvement at Day 7 was 5.3 letters ( branch retinal vein occlusion , 5.1 ; and central retinal vein occlusion , 5.8 ) with DEX implant and 1.6 letters ( branch retinal vein occlusion , 2.3 ; and central retinal vein occlusion , 0.1 ) with sham ( P < 0.001 ) .
-RESULTS	The mean time from initial observation of 15-letter BCVA gain to the last observation of 15-letter BCVA gain was 70 days .
-CONCLUSIONS	Dexamethasone intravitreal implant treatment led to improvement in BCVA compared with sham procedure as early as postimplant Day 7 .
-CONCLUSIONS	The duration of 3-line improvement was typically 2 to 3 months .
-
-###24937967
-OBJECTIVE	To investigate the effect of luteal phase support with vaginal progesterone on pregnancy rates of the gonadotropin-stimulated intrauterine insemination ( IUI ) cycles in patients with unexplained infertility with regard tofollicular growth .
-METHODS	A total of 149 patients with unexplained infertility who underwent 166 recombinant follicle stimulated hormone -- stimulated IUI cycles were prospectively randomized into 2 groups for luteal phase support .
-METHODS	The study group ( n = 71 ) received vaginal progesterone gel supplementation , and the control group ( n = 78 ) received no drug for luteal support .
-METHODS	The clinical pregnancy rates and live birth rates per cycle and per patient were compared between the groups .
-RESULTS	The differences between the groups with regard to clinical pregnancy rates and live birth rates per patient or per cycle were not different among all patients .
-RESULTS	In cycles with > 1 dominant follicle ( multifollicular response ) , the clinical pregnancy rate per patient was significantly higher in the supported cycles as compared with the unsupported cycles ( 28.2 % vs. 11.4 % , respectively , p = 0.04 ) .
-RESULTS	Reproductive outcomes in cycles with a single dominant follicle ( monofollicular response ) were not different between supported and unsupported cycles .
-CONCLUSIONS	Luteal phase support with vaginal progesterone affects the success of gonadotropin-stimulated IUI cycles with multifollicular response but not with monofollicular response .
-
-###25559798
-OBJECTIVE	Linifanib , a potent , selective inhibitor of vascular endothelial growth factor ( VEGF ) and platelet-derived growth factor ( PDGF ) receptors , has single-agent activity in non-small-cell lung cancer ( NSCLC ) .
-OBJECTIVE	We evaluated linifanib with carboplatin and paclitaxel as first-line therapy of advanced nonsquamous NSCLC .
-METHODS	Patients with stage IIIB/IV nonsquamous NSCLC were randomly assigned to 3-week cycles of carboplatin ( area under the curve 6 ) and paclitaxel ( 200 mg/m ( 2 ) ) with daily placebo ( arm A ) , linifanib 7.5 mg ( arm B ) , or linifanib 12.5 mg ( arm C ) .
-METHODS	The primary end point was progression-free survival ( PFS ) ; secondary efficacy end points included overall survival ( OS ) and objective response rate .
-RESULTS	One hundred thirty-eight patients were randomly assigned ( median age , 61 years ; 57 % men ; 84 % smokers ) .
-RESULTS	Median PFS times were 5.4 months ( 95 % CI , 4.2 to 5.7 months ) in arm A ( n = 47 ) , 8.3 months ( 95 % CI , 4.2 to 10.8 months ) in arm B ( n = 44 ) , and 7.3 months ( 95 % CI , 4.6 to 10.8 months ) in arm C ( n = 47 ) .
-RESULTS	Hazard ratios ( HRs ) for PFS were 0.51 for arm B versus A ( P = .022 ) and 0.64 for arm C versus A ( P = .118 ) .
-RESULTS	Median OS times were 11.3 , 11.4 , and 13.0 months in arms A , B , and C , respectively .
-RESULTS	HRs for OS were 1.08 for arm B versus A ( P = .779 ) and 0.88 for arm C versus A ( P = .650 ) .
-RESULTS	Both linifanib doses were associated with increased toxicity , including a higher incidence of adverse events known to be associated with VEGF/PDGF inhibition .
-RESULTS	Baseline plasma carcinoembryonic antigen/cytokeratin 19 fragments biomarker signature was associated with PFS improvement and a trend toward OS improvement with linifanib 12.5 mg .
-CONCLUSIONS	Addition of linifanib to chemotherapy significantly improved PFS ( arm B ) , with a modest trend for survival benefit ( arm C ) and increased toxicity reflective of known VEGF/PDGF inhibitory effects .
-
-###24447629
-OBJECTIVE	To compare the effects of two of the most effective lipid-lowering therapies with similar LDL-cholesterol reduction capacity on the innate and adaptive immune responses through the evaluation of autoantibodies anti-oxidized LDL ( anti-oxLDL Abs ) and electronegative LDL [ LDL ( - ) ] levels .
-METHODS	We performed a prospective , randomized , open label study , with parallel arms and blinded endpoints .
-METHODS	One hundred and twelve subjects completed the study protocol and received rosuvastatin 40 mg or ezetimibe/simvastatin 10/40 mg for 12 weeks .
-METHODS	Lipids , apolipoproteins , LDL ( - ) , and anti-oxLDL Abs ( IgG ) were assayed at baseline and end of study .
-RESULTS	Main clinical and laboratory characteristics were comparable at baseline .
-RESULTS	Lipid modifications were similar in both treatment arms , however , a significant raise in anti-oxLDL Abs levels was observed in subjects treated with rosuvastatin ( p = 0.026 vs. baseline ) , but not in those receiving simvastatin/ezetimibe .
-RESULTS	( p = 0.233 vs. baseline ) , thus suggesting modulation of adaptive immunity by a potent statin .
-RESULTS	Titers of LDL ( - ) were not modified by the treatments .
-CONCLUSIONS	Considering atherosclerosis as an immune disease , this study adds new information , showing that under similar LDL-cholesterol reduction , the choice of lipid-lowering therapy can differently modulate adaptive immune responses .
-
-###26376528
-OBJECTIVE	The aim of the study was to compare two techniques of pyramidalis muscle dissection during cesarean section .
-METHODS	A total of 108 patients undergoing a cesarean section were randomly allocated to group I ( N = 57 ) , with the pyramidalis muscle left attached to the rectus muscles , and group II ( N = 51 ) , with preservation of the connection between the pyramidalis muscle and the rectus sheath .
-RESULTS	There were no statistically significant differences between the groups regarding surgery duration , blood loss and postoperative pain .
-RESULTS	After three months , patients from group II more frequently reported paresthesia in the scar region ( 47.1 vs. 28.1 % ; p = 0.041 ) , but their self-assessment of the abdominal appearance and presence of the bulging below the wound were comparable with group I.
-CONCLUSIONS	None of the two techniques of pyramidalis muscle dissection appear to be superior to the other .
-CONCLUSIONS	The technique leaving the pyramidalis muscle attached to the fascia gave more frequent paresthesia during a 3-month follow-up .
-
-###24325778
-BACKGROUND	The importance of functional properties of high-density lipoproteins ( HDL ) for atheroprotection is increasingly recognized .
-BACKGROUND	We determined the impact of lipid-lowering therapy on 3 key HDL functionalities in Type 2 diabetes mellitus ( T2DM ) .
-METHODS	A placebo-controlled , randomized cross-over study ( three 8-week treatment periods with simvastatin ( 40 mg daily ) , bezafibrate ( 400 mg daily ) , alone and in combination ) was carried out in 14 men with T2DM .
-METHODS	Cholesterol efflux was determined using human THP-1 monocyte-derived macrophages , HDL antioxidative capacity was measured as inhibition of low-density lipoprotein oxidation in vitro , and HDL anti-inflammatory capacity was assessed as suppression of thrombin-induced monocyte chemotactic protein 1 expression in human umbilical vein endothelial cells .
-METHODS	Pre -- HDL was assayed using crossed immunoelectrophoresis .
-RESULTS	While cholesterol efflux increased in response to simvastatin , bezafibrate and combination treatment ( +12 to +23 % ; anova , P = 0.001 ) , HDL antioxidative capacity ( P = 0.23 ) and HDL anti-inflammatory capacity ( P = 0.15 ) did not change significantly .
-RESULTS	Averaged changes in cellular cholesterol efflux during active treatment were correlated positively with changes in HDL cholesterol , apoA-I and pre -- HDL ( P < 0.05 to P < 0.001 ) .
-RESULTS	There were no inter-relationships between changes in the three HDL functionalities during treatment ( P > 0.10 ) .
-RESULTS	Changes in HDL antioxidative capacity and anti-inflammatory capacity were also unrelated to changes in HDL cholesterol and apoA-I , while changes in HDL antioxidative capacity were related inversely to pre -- HDL ( P < 0.05 ) .
-CONCLUSIONS	Simvastatin and bezafibrate increase cholesterol efflux , parallel to HDL cholesterol and apoA-I responses .
-CONCLUSIONS	The antioxidative and anti-inflammatory properties of HDL are not to an important extent affected by these therapeutic interventions .
-
-###24561014
-OBJECTIVE	Regulatory Foxp3-expressing T cells ( Tregs ) , IL-10-producing B cells ( Bregs ) , and IDO-expressing dendritic cells ( DCregs ) downregulate inflammatory processes and induce peripheral tolerance , while Th17A and Th22 cell subpopulations are of proinflammatory nature .
-OBJECTIVE	The aims of the study were to characterize and to enumerate peripheral Tregs , Bregs , and DCregs and Th17A and Th22 cell subpopulations in kidney transplant recipients ( KTRs ) under belatacept or cyclosporine treatment .
-METHODS	Forty-one KRT patients ( 30 under belatacept treatment and 11 under cyclosporine treatment ) and 26 healthy donors ( HDs ) were included in the study .
-METHODS	CD19 ( + ) - expressing peripheral B lymphocytes were purified by positive selection .
-METHODS	IL-10-producing B cells , CD4 ( + ) / CD25 ( high ) Foxp3 ( + ) , and CD8 ( + ) / CD28 ( - ) Foxp3 ( + ) Tregs , CCR6 ( + ) / CD123 ( + ) / IDO ( + ) DCs , as well as Th17A and Th22 cell subpopulations were quantitated by flow cytometry .
-RESULTS	Of the IL-10-producing Bregs , CD19 ( + ) / CD24 ( high ) / CD38 ( high ) / CD5 ( + ) , CD19 ( + ) / CD24 ( high ) / CD38 ( high ) / CD10 ( + ) , CD19 ( + ) / CD24 ( high ) / CD38 ( high ) / CD20 ( + ) , and CD19 ( + ) / CD24 ( high ) / CD38 ( high ) / CD27 ( - ) had significant higher frequency in patients under belatacept treatment when compared with those under cyclosporine .
-RESULTS	Only CD19 ( + ) / CD24 ( high ) / CD38 ( high ) / CD27 ( + ) and CD19 ( + ) / CD24 ( high ) / CD38 ( high ) / CXCR7 ( + ) cells had significant higher frequency in patients under cycloporine treatment when compared to those under belatacept .
-RESULTS	The percentages of IDO-expressing pDC , CD4 ( + ) / CD25 ( high ) Foxp3 ( + ) , and CD8 ( + ) / CD28 ( - ) Foxp3 ( + ) were significantly higher in the belatacept group when compared the cyclosporine one , while Th17A and Th22 cells had significant higher frequency in the latter group .
-CONCLUSIONS	Belatacept seems to maintain and enhance , at least systemically , a tolerant profile to renal allograft in transplant recipients by means of higher circulatory frequencies of regulatory B , T and pDC subpopulations .
-
-###25478898
-BACKGROUND	In the United Kingdom , patients with locally advanced rectal cancer routinely receive neoadjuvant chemoradiotherapy .
-BACKGROUND	However , the effects of this on physical fitness are unclear .
-BACKGROUND	This pilot study is aimed to investigate the effect of neoadjuvant chemoradiotherapy on objectively measured in vivo muscle mitochondrial function and whole-body physical fitness .
-METHODS	We prospectively studied 12 patients with rectal cancer who completed standardized neoadjuvant chemoradiotherapy , recruited from a large tertiary cancer centre , between October 2012 and July 2013 .
-METHODS	All patients underwent a cardiopulmonary exercise test and a phosphorus magnetic resonance spectroscopy quadriceps muscle exercise-recovery study before and after neoadjuvant chemoradiotherapy .
-METHODS	Data were analysed and reported blind to patient identity and clinical course .
-METHODS	Primary variables of interest were the two physical fitness measures ; oxygen uptake at estimated anaerobic threshold and oxygen uptake at Peak exercise ( ml.kg-1 .
-METHODS	min-1 ) , and the post-exercise phosphocreatine recovery rate constant ( min-1 ) , a measure of muscle mitochondrial capacity in vivo .
-RESULTS	Median age was 67 years ( IQR 64-75 ) .
-RESULTS	Differences ( 95 % CI ) in all three primary variables were significantly negative post-NACRT : Oxygen uptake at estimated anaerobic threshold -2.4 ml.kg-1 .
-RESULTS	min-1 ( -3.8 , -0.9 ) , p = 0.004 ; Oxygen uptake at Peak -4.0 ml.kg-1 .
-RESULTS	min-1 ( -6.8 , -1.1 ) , p = 0.011 ; and post-exercise phosphocreatine recovery rate constant -0.34 min-1 ( -0.51 , -0.17 ) , p < 0.001 .
-CONCLUSIONS	The significant decrease in both whole-body physical fitness and in vivo muscle mitochondrial function raises the possibility that muscle mitochondrial mechanisms , no doubt multifactorial , may be important in deterioration of physical fitness following neoadjuvant chemoradiotherapy .
-CONCLUSIONS	This may have implications for targeted interventions to improve physical fitness pre-surgery .
-BACKGROUND	Clinicaltrials.gov registration NCT01859442 .
-
-###24356398
-OBJECTIVE	To evaluate the effect of periodontal treatment on gingival overgrowth in a group of renal transplant patients .
-METHODS	Twenty-five renal transplant recipients receiving immunosuppressive therapy with cyclosporine A ( CsA ) were randomly assigned to 2 groups .
-METHODS	Group 1 ( n = 15 ) included patients who had been specifically referred to a dental clinic to prevent gingival overgrowth and were given full periodontal therapy .
-METHODS	Group 2 ( n = 10 ) was comprised of patients who did not receive any professional periodontal cleaning .
-METHODS	Patients from both groups were examined to determine their periodontal status before and after 3 , 6 and 12 months in terms of their plaque index , gingival index and gingival overgrowth .
-METHODS	During the examination , their overall health was stable .
-RESULTS	For group 1 , the scores were 1.89 ( baseline ) , 0.98 ( 6 months ) and 0.56 ( 12 months ) , and hence there were significant reductions ( p = 0.0001 ) .
-RESULTS	The gingival indices were 1.71 ( baseline ) , 0.76 ( 6 months ) and 0.35 ( 12 months ) , and the reductions were also significant ( p = 0.0001 ) .
-RESULTS	A significant association was observed between poor oral hygiene and the degree of gingival overgrowth .
-RESULTS	The 1-year post-treatment follow-up showed that patients in group 1 did not develop gingival overgrowth due to the use of CsA as group 2 did without prior periodontal therapy .
-CONCLUSIONS	Oral hygiene status was the most important variable related to the development and degree of gingival overgrowth due to the use of CsA .
-
-###24275900
-OBJECTIVE	The use of heat and moisture exchangers ( HME ) during noninvasive ventilation ( NIV ) can increase the work of breathing , decrease alveolar ventilation , and deliver less humidity in comparison with heated humidifiers ( HH ) .
-OBJECTIVE	We tested the hypothesis that the use of HH during NIV with ICU ventilators for patients with acute respiratory failure would decrease the rate of intubation ( primary endpoint ) as compared with HME .
-METHODS	We conducted a multicenter randomized controlled study in 15 centers .
-METHODS	After stratification by center and type of respiratory failure ( hypoxemic or hypercapnic ) , eligible patients were randomized to receive NIV with HH or HME .
-RESULTS	Of the 247 patients included , 128 patients were allocated to the HME group and 119 to the HH group .
-RESULTS	Patients were comparable at baseline .
-RESULTS	The intubation rate was not significantly different : 29.7 % in the HME group and 36.9 % in the HH group ( p = 0.28 ) .
-RESULTS	PaCO2 did not significantly differ between the two arms , even in the subgroup of hypercapnic patients .
-RESULTS	No significant difference was observed for NIV duration , ICU and hospital LOS , or ICU mortality ( HME 14.1 vs. HH 21.5 % , p = 0.18 ) .
-CONCLUSIONS	In this study , the short-term physiological benefits of HH in comparison with HME during NIV with ICU ventilators were not observed , and no difference in intubation rate was found .
-CONCLUSIONS	The physiologic effects may have been obscured by leaks or other important factors in the clinical settings .
-CONCLUSIONS	This study does not support the recent recommendation favoring the use of HH during NIV with ICU ventilators .
-
-###24571855
-BACKGROUND	Chronic pain can disrupt the cortical representation of a painful body part .
-BACKGROUND	This disruption may play a role in maintaining the individual 's pain .
-BACKGROUND	Tactile acuity training has been used to normalise cortical representation and reduce pain in certain pain conditions .
-BACKGROUND	However , there is little evidence for the effectiveness of this intervention for chronic low back pain ( CLBP ) .
-BACKGROUND	The primary aim of this study was to inform the development of a fully powered randomised controlled trial ( RCT ) by providing preliminary data on the effect of tactile acuity training on pain and function in individuals with CLBP .
-BACKGROUND	The secondary aim was to obtain qualitative feedback about the intervention .
-METHODS	In this mixed-methods pilot RCT 15 individuals were randomised to either an intervention ( tactile acuity training ) or a placebo group ( sham tactile acuity training ) .
-METHODS	All participants received 3 sessions of acuity training ( intervention or sham ) from a physiotherapist and were requested to undertake daily acuity home training facilitated by an informal carer ( friend/relative ) .
-METHODS	All participants also received usual care physiotherapy .
-METHODS	The primary outcome measures were pain ( 0-100visual analogue scale ( VAS ) ) and function ( Roland Morris Disability Questionnaire ( RMDQ ) ) .
-METHODS	Participants and their informal carers were invited to a focus group to provide feedback on the intervention .
-RESULTS	The placebo group improved by the greatest magnitude for both outcome measures , but there was no statistically significant difference ( Mean difference ( 95 % CI ) , p-value ) between groups for change in pain ( 25.6 ( -0.7 to 51.9 ) , p = 0.056 ) or function ( 2.2 ( -1.6 to 6.0 ) , p = 0.237 ) .
-RESULTS	Comparing the number of individuals achieving a minimally clinically significant improvement , the placebo group had better outcomes for pain with all participants achieving 30 % improvement compared to only a third of the intervention group ( 6/6 vs. 3/9 , p = 0.036 ) .
-RESULTS	Qualitatively , participants reported that needing an informal carer was a considerable barrier to the home training component of the study .
-CONCLUSIONS	This pilot RCT found tactile acuity training to be no more effective than sham tactile acuity training for function and less effective for pain in individuals with CLBP .
-CONCLUSIONS	That the intervention could not be self-applied was a considerable barrier to its use .
-BACKGROUND	ISRCTN98118082 .
-
-###25168853
-BACKGROUND	Chronic obstructive pulmonary disease ( COPD ) is a chronic , progressively debilitating condition that is prevalent in the US and worldwide .
-BACKGROUND	Patients suffer from progressive dyspnea and exercise intolerance .
-BACKGROUND	Physical exercise is beneficial , but conventional pulmonary rehabilitation programs are underutilized .
-BACKGROUND	There remains a need for novel interventions that improve symptoms , quality-of-life , and functional capacity .
-BACKGROUND	Tai chi is an increasingly popular mind-body exercise that includes physical exercise , breathing training , mindful awareness , and stress management -- components that are essential to the self-management of COPD .
-BACKGROUND	There are , however , limited data on the effectiveness of tai chi as a therapeutic intervention in this population .
-METHODS	The Primary Aims are to evaluate the efficacy , safety , and feasibility of a 12-week tai chi program for patients with COPD .
-METHODS	We utilize a randomized controlled trial design , with participants assigned in a 2:1 ratio to either a group tai chi program ( N = 63 ) or a time/attention-matched education control ( N = 31 ) .
-METHODS	Our primary outcomes are COPD-specific quality-of-life and exercise capacity .
-METHODS	Secondary outcomes include dyspnea , mood , functional status , self-efficacy , and lung function .
-METHODS	Cardiopulmonary exercise testing is done in a subset of patients ( N = 50 ) .
-METHODS	To explore optimal training duration , a subgroup of patients in tai chi are randomly assigned to complete an additional 12 weeks training ( total 24 weeks ) ( Exploratory Aim 1 ) .
-METHODS	To explore the impact of a simplified seated intervention including only a subset of tai chi 's training components , a third randomly assigned group ( N = 31 ) receives a 12 - week mind-body breathing program ( N = 31 ) ( Exploratory Aim 2 ) .
-CONCLUSIONS	Results of the BEAM study ( Breathing , Education , Awareness , Movement ) will provide preliminary evidence regarding the value of tai chi for improving quality of life and exercise capacity in patients with COPD , including information regarding optimal duration .
-CONCLUSIONS	They will also inform the feasibility and potential benefit of an alternative mind-body breathing intervention , and provide insight regarding how isolated mind-body exercise components contribute to the overall effects of tai chi .
-CONCLUSIONS	Should the results be positive , tai chi and related mind-body practices may offer a novel exercise option that is potentially accessible to a large proportion of patients with COPD .
-BACKGROUND	This trial is registered in Clinical Trials.gov , ID number NCT01551953 .
-BACKGROUND	Date of Registration March 1 2012 .
-
-###25347723
-OBJECTIVE	To determine whether a pharmacist-led medications review in primary care reduces the number of drugs and the number of drug-related problems .
-METHODS	Prospective randomized controlled trial .
-METHODS	Liljeholmen Primary Care Centre , Stockholm , Sweden .
-METHODS	209 patients aged 65 years with five or more different medications .
-METHODS	Intervention .
-METHODS	Patients answered a questionnaire regarding medications .
-METHODS	The pharmacist reviewed all medications ( prescription , non-prescription , and herbal ) regarding recommendations and renal impairment , giving advice to patients and GPs .
-METHODS	Each patient met the pharmacist before seeing their GP .
-METHODS	Control patients received their usual care .
-METHODS	Drug-related problems and number of drugs .
-METHODS	Secondary outcomes included health care utilization and self-rated health during 12 months of follow-up .
-RESULTS	No significant difference was seen when comparing change in drug-related problems between the groups .
-RESULTS	However , a significant decrease in drug-related problems was observed in the intervention group ( from 1.73 per patient at baseline to 1.31 at follow-up , p < 0.05 ) .
-RESULTS	The change in number of drugs was more pronounced in the intervention group ( p < 0.046 ) .
-RESULTS	Intervention group patients were not admitted to hospital on fewer occasions or for fewer days , and there was no significant difference between the two groups regarding utilization of primary care during follow-up .
-RESULTS	Self-rated health remained unchanged in the intervention group , whereas a drop ( p < 0.02 ) was reported in the control group .
-RESULTS	This resulted in a significant difference in change in self-rated health between the groups ( p < 0.047 ) .
-CONCLUSIONS	The addition of a skilled pharmacist to the primary care team may contribute to reductions in numbers of drugs and maintenance of self-rated health in elderly patients with polypharmacy .
-
-###26028283
-OBJECTIVE	Exercise evokes pulsatile GH release followed by autonegative feedback , whereas glucose suppresses GH release followed by rebound-like GH release ( feedforward escape ) .
-OBJECTIVE	Here we test the hypothesis that age , sex steroids , insulin , body composition and physical power jointly determine these dynamic GH responses .
-METHODS	This was a prospectively randomized glucose-blinded study conducted in the Mayo Center for Advancing Translational Sciences in healthy men ages 19-77 years ( N = 23 ) .
-METHODS	Three conditions , fasting/rest/saline , fasting/exercise/saline and fasting/rest/iv glucose infusions , were used to drive GH dynamics during 10-min blood sampling for 6h .
-METHODS	Linear correlation analysis was applied to relate peak/nadir GH dynamics to age , sex steroids , insulin , CT-estimated abdominal fat and physical power ( work per unit time ) .
-RESULTS	Compared with the fasting/rest/saline ( control ) day , fasting/exercise/saline infusion evoked peak GH within 1h , followed by negative feedback 3-5h later .
-RESULTS	The dynamic GH excursion was strongly ( R ( 2 ) = 0.634 ) influenced by ( i ) insulin negatively ( P = 0.011 ) , ( ii ) power positively ( P = 0.0008 ) , and ( iii ) E2 positively ( P = 0.001 ) .
-RESULTS	Dynamic glucose-modulated GH release was determined by insulin negatively ( P = 0.0039 ) and power positively ( P = 0.0034 ) ( R ( 2 ) = 0.454 ) .
-RESULTS	Under rest/saline , power ( P = 0.031 ) and total abdominal fat ( P = 0.012 ) ( R ( 2 ) = 0.267 ) were the dominant correlates of GH excursions .
-CONCLUSIONS	In healthy men , dynamic GH perturbations induced by exercise and glucose are strongly related to physical power , insulin , estradiol , and body composition , thus suggesting a network of regulatory pathways .
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-###25533727
-BACKGROUND	Observational evidence from behavioral weight control trials and community studies suggests that greater frequency of weighing oneself , or tracking weight , is associated with better weight outcomes .
-BACKGROUND	Conversely , it has also been suggested that frequent weight tracking may have a negative impact on mental health and outcomes during weight loss , but there are minimal experimental data that address this concern in the context of an active weight loss program .
-BACKGROUND	To achieve the long-term goal of strengthening behavioral weight loss programs , the purpose of this randomized controlled trial ( the Tracking Study ) is to test variations on frequency of self-weighing during a behavioral weight loss program , and to examine psychosocial and mental health correlates of weight tracking and weight loss outcomes .
-BACKGROUND	This paper describes the study design , intervention features , recruitment , and baseline characteristics of participants enrolled in the Tracking Study .
-METHODS	Three hundred thirty-nine overweight and obese adults were recruited and randomized to one of three variations on weight tracking frequency during a 12-month weight loss program with a 12-month follow-up : daily weight tracking , weekly weight tracking , or no weight tracking .
-METHODS	The primary outcome is weight in kilograms at 24 months .
-METHODS	The weight loss program integrates each weight tracking instruction with standard behavioral weight loss techniques ( goal setting , self-monitoring , stimulus control , dietary and physical activity enhancements , lifestyle modifications ) ; participants in weight tracking conditions were provided with wireless Internet technology ( wi-fi-enabled digital scales and touchscreen personal devices ) to facilitate weight tracking during the study .
-CONCLUSIONS	This study was successful in recruiting adult male and female participants and is positioned to enhance the standard of care with regard to weight tracking recommendations .
-
-###25042759
-BACKGROUND	This Stage II trial builds on a Stage I trial comparing the single-gender Women 's Recovery Group ( WRG ) to mixed-gender Group Drug Counseling ( GDC ) that demonstrated preliminary support for the WRG in treating women with substance use disorders .
-BACKGROUND	The Stage II trial aims were to ( 1 ) investigate effectiveness of the WRG relative to GDC in a sample of women heterogeneous with respect to substance of abuse and co-occurring psychiatric disorders , and ( 2 ) demonstrate the feasibility of implementing WRG in an open-enrollment group format at two sites .
-METHODS	In this randomized clinical trial , participants were included if they were substance dependent and had used substances within the past 60 days ( n = 158 ) .
-METHODS	Women were randomized to WRG ( n = 52 ) or GDC ( n = 48 ) ; men were assigned to GDC ( n = 58 ) .
-METHODS	Substance use outcomes were assessed at months 1-6 and 9 .
-RESULTS	Women in both the WRG and GDC had reductions in mean number of substance use days during treatment ( 12.7 vs 13.7 day reductions for WRG and GDC , respectively ) and 6 months post-treatment ( 10.3 vs 12.7 day reductions ) ; however , there were no significant differences between groups .
-CONCLUSIONS	The WRG demonstrated comparable effectiveness to standard mixed-gender treatment ( i.e. , GDC ) and is feasibly delivered in an open-group format typical of community treatment .
-CONCLUSIONS	It provides a manual-based group therapy with women-focused content that can be implemented in a variety of clinical settings for women who are heterogeneous with respect to their substance of abuse , other co-occurring psychiatric disorders , and life-stage .
-
-###25544294
-OBJECTIVE	Recently , attention has been paid to dexmedetomidine , a selective -2 adrenoceptor agonist , as a possible additive for local anesthesia .
-OBJECTIVE	However , the effect of locally injected dexmedetomidine on the anesthetic action in humans has not fully been clarified .
-OBJECTIVE	Thus , the purpose of the present study was to evaluate the effect of dexmedetomidine injected into the oral mucosa in combination with lidocaine on local anesthetic potency in humans .
-METHODS	Twenty healthy volunteers were included in the present crossover double-blinded study .
-METHODS	Lidocaine solution or lidocaine plus dexmedetomidine solution was submucosally injected into the alveolar mucosa in a crossover and double-blinded manner .
-METHODS	The local anesthetic effect of the solutions was evaluated by measuring the current perception threshold ( CPT ) in the oral mucosa for 120 minutes after injection .
-METHODS	Furthermore , the sedation level , blood pressure , and heart rate of the volunteers were evaluated .
-METHODS	For statistical analysis , the Wilcoxon signed rank test and 2-way repeated measures analysis of variation were used .
-RESULTS	The CPT was increased with the 2 solutions and peaked 10 minutes after injection .
-RESULTS	CPT values 10 and 20 minutes after injection of lidocaine plus dexmedetomidine solution were considerably higher than those with lidocaine solution .
-RESULTS	The duration of an important increase in the CPT after injection with lidocaine plus dexmedetomidine solution was longer than that with lidocaine .
-RESULTS	Furthermore , the area under the time curve of CPT was considerably higher with lidocaine plus dexmedetomidine solution than with lidocaine solution .
-RESULTS	No volunteer showed a change in sedation level , blood pressure , or heart rate after injection with either test solution throughout the experiment .
-CONCLUSIONS	The present study showed that a combination of dexmedetomidine plus lidocaine considerably enhances the local anesthetic potency of lidocaine without any major influences on the cardiovascular system when locally injected into the oral mucosa .
-
-###25877784
-BACKGROUND	The purpose of this study was to determine the efficacy of a clinician referral and exercise program in improving exercise levels and quality of life for men with prostate cancer .
-METHODS	This was a multicenter cluster randomized controlled trial in Melbourne , Australia comprising 15 clinicians : 8 clinicians were randomized to refer eligible participants ( n = 54 ) to a 12-week exercise program comprising 2 supervised gym sessions and 1 home-based session per week , and 7 clinicians were randomized to follow usual care ( n = 93 ) .
-METHODS	The primary outcome was self-reported physical activity ; the secondary outcomes were quality of life , anxiety , and symptoms of depression .
-RESULTS	A significant intervention effect was observed for vigorous-intensity exercise ( effect size : Cohen 's d , 0.46 ; 95 % confidence interval [ CI ] , 0.09-0 .82 ; P = .010 ) but not for combined moderate and vigorous exercise levels ( effect size : d , 0.08 ; 95 % CI , -0.28 to 0.45 ; P = .48 ) .
-RESULTS	Significant intervention effects were also observed for meeting exercise guidelines ( 150 min/wk ; odds ratio , 3.9 ; 95 % CI , 1.9-7 .8 ; P = .002 ) ; positive intervention effects were observed in the intervention group for cognitive functioning ( effect size : d , 0.34 ; 95 % CI , -0.02 to 0.70 ; P = .06 ) and depression symptoms ( effect size : d , -0.35 ; 95 % CI , -0.71 to 0.02 ; P = .06 ) .
-RESULTS	Eighty percent of participants reported that the clinician 's referral influenced their decision to participate in the exercise program .
-CONCLUSIONS	The clinician referral and 12-week exercise program significantly improved vigorous exercise levels and had a positive impact on mental health outcomes for men living with prostate cancer .
-CONCLUSIONS	Further research is needed to determine the sustainability of the exercise program and its generalizability to other cancer populations .
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-###25083980
-OBJECTIVE	To compare the effectiveness and safety of the hemoglobin-based nitric oxide scavenger , pyridoxalated hemoglobin polyoxyethylene , against placebo in patients with vasopressor-dependent distributive shock .
-METHODS	Multicenter , randomized , placebo-controlled , open-label study .
-METHODS	Sixty-one participating ICUs in six European countries ( Austria , Belgium , Germany , the Netherlands , Spain , and United Kingdom ) .
-METHODS	All patients admitted with distributive shock , defined as the presence of at least two systemic inflammatory response syndrome criteria , persisting norepinephrine dependence and evidence of organ dysfunction/hypoperfusion despite adequate fluid resuscitation .
-METHODS	Patients were randomized to receive 0.25 mL/kg/hr pyridoxalated hemoglobin polyoxyethylene ( 20 mg Hb/kg/hr ) or an equal volume of placebo , infused for up to 150 hours , in addition to conventional vasopressor therapy .
-RESULTS	The study was stopped after interim analysis showed higher mortality in the pyridoxalated hemoglobin polyoxyethylene group and an increased prevalence of adverse events .
-RESULTS	At this time , 377 patients had been randomized to pyridoxalated hemoglobin polyoxyethylene ( n = 183 ) or placebo ( n = 194 ) .
-RESULTS	Age , gender , type of patient ( medical/surgical ) , and Acute Physiology and Chronic Health Evaluation II scores were similar between groups .
-RESULTS	Twenty-eight-day mortality rate was 44.3 % in the pyridoxalated hemoglobin polyoxyethylene group versus 37.6 % in the placebo group ( OR , 1.29 ; 95 % CI , 0.85-1 .95 ; p = 0.227 ) .
-RESULTS	In patients with higher organ dysfunction scores ( Sepsis-related Organ Failure Assessment > 13 ) , mortality rates were significantly higher in the pyridoxalated hemoglobin polyoxyethylene group when compared with those in placebo-treated patients ( 60.9 % vs 39.2 % ; p = 0.014 ) .
-RESULTS	Survivors who received pyridoxalated hemoglobin polyoxyethylene had a longer vasopressor-free time ( 21.3 vs 19.7 d ; p = 0.035 ) .
-CONCLUSIONS	In this randomized , controlled phase III trial in patients with vasopressor-dependent distributive shock , administration of a pyridoxalated hemoglobin solution decreased the need for vasopressors but was associated with a trend to increased mortality .
-
-###25227824
-BACKGROUND	Few Iranian women take the Papanicolaou test despite its important role in preventing cervical cancer .
-BACKGROUND	This study aimed to determine the effectiveness of an educational intervention based on the protection motivation theory ( PMT ) variables and implementation intentions in the first and second Pap test practice among Iranian women .
-METHODS	In this quasi-randomized controlled trial , 200 women who were referred to 30 primary health care clinics in Tehran were randomly selected .
-METHODS	PMT variables and Pap test practice were measured at baseline and again after 3 and 15 months .
-METHODS	The 4-week educational intervention program was conducted for the intervention group .
-RESULTS	Following the intervention , the mean scores of self-efficacy , perceived vulnerability , and behavior intention variables were significantly higher in the intervention group when compared to the control group ( p < 0.05 ) .
-RESULTS	No significant differences were found in the perceived severity , response efficacy , response cost , and fear between the two groups following the intervention .
-RESULTS	Higher percent of women in the intervention group had obtained first and second Pap test compared to the controls .
-CONCLUSIONS	The PMT and implementation intentions provide a suitable theory-based framework for developing educational interventions regarding Pap test practice in Iran .
-
-###25401779
-BACKGROUND	Pelvic floor muscle training ( PFMT ) has level 1 evidence of reducing the size and symptoms associated with pelvic organ prolapse ( POP ) .
-BACKGROUND	There is scant knowledge , however , regarding whether PFMT has an effect on sexual function .
-OBJECTIVE	The aim of the trial was to evaluate the effect of PFMT on sexual function in women with POP .
-METHODS	In this randomized controlled trial , 50 women were randomized to an intervention group ( 6 months of PFMT and lifestyle advice ) and 59 women were randomized to a control group ( lifestyle advice only ) .
-METHODS	Participants completed a validated POP-specific questionnaire to describe frequency and bother of prolapse , bladder , bowel , and sexual symptoms and answered a semi-structured interview .
-RESULTS	No significant change in number of women being sexually active was reported .
-RESULTS	There were no significant differences between groups regarding change in satisfaction with frequency of intercourse .
-RESULTS	Interview data revealed that 19 ( 39 % ) of women in the PFMT group experienced improved sexual function vs. two ( 5 % ) in the control group ( P < 0.01 ) .
-RESULTS	Specific improvements reported by some of the women were increased control , strength and awareness of the pelvic floor , improved self-confidence , sensation of a `` tighter '' vagina , improved libido and orgasms , resolution of pain with intercourse , and heightened sexual gratification for partners .
-RESULTS	Women who described improved sexual function demonstrated the greatest increases in pelvic floor muscle ( PFM ) strength ( mean 16 10 cmH2 0 ) and endurance ( mean 150 140 cmH2 0s ) ( P < 0.01 ) .
-CONCLUSIONS	PFMT can improve sexual function in some women .
-CONCLUSIONS	Women reporting improvement in sexual function demonstrated the greatest increase in PFM strength and endurance .
-
-###25270758
-OBJECTIVE	Service user satisfaction with therapy is a key part of the therapeutic process .
-OBJECTIVE	The aim of this study was to investigate service user experiences of an 11-week group positive psychology intervention for psychosis ( WELLFOCUS PPT ) in the context of a randomized controlled trial ( ISRCTN04199273 ) .
-METHODS	Participants were 37 individuals ( 51 % male ; mean age 45.6 years ) receiving the intervention as part of the trial .
-METHODS	Semistructured interviews and focus groups were conducted to investigate participants ' views of WELLFOCUS PPT .
-METHODS	Transcripts were analyzed both deductively and inductively to identify common themes .
-RESULTS	Feedback about the group experience was positive throughout .
-RESULTS	Components found helpful included learning to savor experiences , identifying and developing strengths , forgiveness , gratitude , and therapist self-disclosure .
-CONCLUSIONS	Findings emphasize the importance of considering service users ' perceptions of therapy and can be used to guide clinicians in deciding whether to include one or more of the components of WELLFOCUS PPT in therapy .
-
-###25079934
-OBJECTIVE	To determine the effectiveness of a single perioperative prophylactic 2g dose of cephalexin in preventing surgical site infection ( SSI ) following excision of skin lesions from the lower limb .
-METHODS	Prospective double-blinded placebo-controlled trial testing for difference in infection rates .
-METHODS	Primary care in regional North Queensland , Australia .
-METHODS	52 patients undergoing lower limb skin lesion excision .
-METHODS	2g dose of cephalexin 30-60min before excision .
-METHODS	Incidence of SSI .
-RESULTS	Incidence of SSI was 12.5 % ( 95 % CI 2.7 % to 32.4 % ) in the cephalexin group compared with 35.7 % ( 95 % CI 18.6 % to 55.9 % ) in the placebo group ( p = 0.064 ) .
-RESULTS	This represented an absolute reduction of 23.21 % ( 95 % CI -0.39 % to 46.82 % ) , relative reduction of 65.00 % ( 95 % CI -12.70 % to 89.13 % ) and number-needed-to-treat of 4.3 .
-CONCLUSIONS	Administration of a single 2g dose of cephalexin 30-60min before skin lesion excision from the lower limb may produce a reduction in the incidence of infection ; however , this study was underpowered to statistically determine this .
-BACKGROUND	ACTRN12611000595910 .
-
-###25042199
-BACKGROUND	Multicentric Castleman 's disease is a rare lymphoproliferative disorder driven by dysregulated production of interleukin 6 .
-BACKGROUND	No randomised trials have been done to establish the best treatment for the disease .
-BACKGROUND	We assessed the safety and efficacy of siltuximab-a chimeric monoclonal antibody against interleukin 6-in HIV-negative patients with multicentric Castleman 's disease .
-METHODS	We did this randomised , double-blind , placebo-controlled study at 38 hospitals in 19 countries worldwide .
-METHODS	We enrolled HIV-negative and human herpesvirus-8-seronegative patients with symptomatic multicentric Castleman 's disease .
-METHODS	Treatment allocation was randomised with a computer-generated list , with block size six , and stratification by baseline corticosteroid use .
-METHODS	Patients and investigators were masked to treatment allocation .
-METHODS	Patients were randomly assigned ( 2:1 ) to siltuximab ( 11 mg/kg intravenous infusion every 3 weeks ) or placebo ; all patients also received best supportive care .
-METHODS	Patients continued treatment until treatment failure .
-METHODS	The primary endpoint was durable tumour and symptomatic response for at least 18 weeks for the intention-to-treat population .
-METHODS	Enrolment has been completed .
-METHODS	The study is registered with ClinicalTrials.gov , number NCT01024036 .
-RESULTS	We screened 140 patients , 79 of whom were randomly assigned to siltuximab ( n = 53 ) or placebo ( n = 26 ) .
-RESULTS	Durable tumour and symptomatic responses occurred in 18 ( 34 % ) of 53 patients in the siltuximab group and none of 26 in the placebo group ( difference 340 % , 95 % CI 111-548 , p = 00012 ) .
-RESULTS	The incidence of grade 3 or more adverse events ( 25 [ 47 % ] vs 14 [ 54 % ] ) and serious adverse events ( 12 [ 23 % ] vs five [ 19 % ] ) was similar in each group despite longer median treatment duration with siltuximab than with placebo ( 375 days [ range 1-1031 ] vs 152 days [ 23-666 ] ) .
-RESULTS	The most common grade 3 or higher were fatigue ( five vs one ) , night sweats ( four vs one ) , and anaemia ( one vs three ) .
-RESULTS	Three ( 6 % ) of 53 patients had serious adverse events judged reasonably related to siltuximab ( lower respiratory tract infection , anaphylactic reaction , sepsis ) .
-CONCLUSIONS	Siltuximab plus best supportive care was superior to best supportive care alone for patients with symptomatic multicentric Castleman 's disease and well tolerated with prolonged exposure .
-CONCLUSIONS	Siltuximab is an important new treatment option for this disease .
-BACKGROUND	Janssen Research & Development .
-
-###25490803
-OBJECTIVE	This article evaluates the effectiveness of two interventions : a self-leveling pallet carousel designed to position the loads vertically and horizontally at origin , and an adjustable cart designed to raise loads vertically at destination to reduce spine loads .
-BACKGROUND	Low back disorders among workers in manual material handling industries are very prevalent and have been linked to manual palletizing operations .
-BACKGROUND	Evidence into the effectiveness of ergonomic interventions is limited , with no research that investigates interventions with adjustable load location .
-METHODS	Thirteen males experienced in manual material handling participated in simulated order selecting tasks where spine loads were quantified for each intervention condition : carousel to traditional cart , pallet to traditional cart , pallet to adjustable cart , and carousel to adjustable cart .
-RESULTS	The results showed that combining both devices results in reduction in spine compression ( 61 % ) , anterior-posterior shear ( 72 % ) , and lateral shear ( 63 % ) compared to traditional palletizing conditions .
-RESULTS	Individually , the carousel was responsible for the greatest reductions , but the lowest values were typically achieved by combining the adjustable cart and carousel .
-CONCLUSIONS	The combination of the interventions ( self-leveling carousel and adjustable cart ) was most effective in reducing the spine loads when compared to the traditional pallet-cart condition .
-CONCLUSIONS	The individual interventions also reduced the loads compared to the traditional condition .
-CONCLUSIONS	With de-palletizing/palletizing tasks being a major source of low back injuries , the combination of self-leveling carousel and adjustable cart has been found to be effective in reducing the peak spine loading as compared to traditional pallet on floor and nonadjustable flat cart conditions .
-
-###25089351
-OBJECTIVE	To determine the influence of omega-3 supplementation on vitreous vascular endothelial growth factor A ( VEGF-A ) levels in patients with exudative age-related macular degeneration ( wet AMD ) receiving intravitreal anti-VEGF treatment .
-METHODS	Prospective , randomized , open-label , single-center , clinical trial , consecutive interventional case series .
-METHODS	The study included 3 cohorts with wet AMD and a control group with epiretinal membrane or macular hole .
-METHODS	Twenty wet AMD patients being treated with anti-VEGF were randomized to daily supplementation of antioxidants , zinc , and carotenoids with omega-3 fatty acids ( docosahexaenoic acid and eicosapentaenoic acid ; group 1 , n = 10 ) or without omega-3 fatty acids ( group 2 , n = 10 ) .
-METHODS	They were compared with an anti-VEGF treatment-nave wet AMD group ( group 3 , n = 10 ) and an epiretinal membrane or macular hole group ( group 4 , n = 10 ) .
-METHODS	Primary outcome was vitreal VEGF-A levels ( at the time of anti-VEGF injection ) .
-METHODS	Secondary outcomes were plasma VEGF-A and central foveal thickness .
-METHODS	Patients with new submacular hemorrhage or any other treatment within 3 months were excluded .
-METHODS	Final analyses included 9 , 6 , 7 , and 8 patients in groups 1 through 4 , respectively .
-RESULTS	Patients receiving omega-3s ( group 1 ) had significantly lower levels of vitreal VEGF-A ( 141.11 61.89 pg/mL ) when compared with group 2 ( 626.09 279.27 pg/mL ; P = .036 ) and group 3 ( 735.48 216.43 pg/mL ; P = .013 ) , but similar levels to group 4 ( 235.81 33.99 pg/mL ; P = .215 ) .
-RESULTS	All groups showed similar values for plasma VEGF-A and central foveal thickness measurements .
-CONCLUSIONS	This study demonstrated that omega-3 supplementation combined with anti-VEGF treatment is associated with decreased vitreal VEGF-A levels in wet AMD patients .
-
-###24748529
-OBJECTIVE	Exercise at 50-60 % of peak oxygen consumption ( VO2 peak ) stimulates maximal fat oxidation rates .
-OBJECTIVE	Despite a lower estimated work performed ; high-intensity intermittent exercise ( HIIE ) training produces greater fat mass reductions when compared with workload-matched continuous ( CON ) steady state exercise .
-OBJECTIVE	No metabolic basis has been documented nor mechanisms offered to explain this anomaly .
-OBJECTIVE	This study investigated the physiological and metabolic responses of two different workload-matched exercise protocols .
-METHODS	On separate occasions and at least 1week apart , eight apparently healthy males cycled for 30min at either 50 % VO2 peak ( CON ) or performed repeated 20s bouts of supramaximal exercise at 150 % VO2 peak separated by 40s rest ( HIIE ) .
-RESULTS	The average heart rate , oxygen consumption , plasma glycerol and free fatty acid concentrations were not different during exercise and recovery between the trials .
-RESULTS	Plasma lactate and hypoxanthine ( Hx ) concentrations were elevated and urinary excretion rates of Hx and uric acid were greater following HIIE as compared to CON ( P < 0.05 ) .
-CONCLUSIONS	Exercise-induced plasma Hx accumulation and urinary purine excretion are greater following HIIE and indirectly represents a net loss of adenosine triphosphate ( ATP ) from the muscle .
-CONCLUSIONS	The subsequent restorative processes required for intramuscular de novo replacement of ATP may contribute to a negative energy balance and in part , account for the potential accelerated fat loss observed with HIIE when compared with CON training programs .
-
-###25054648
-METHODS	Single blinded , randomized clinical trial for the evaluation of lumbosacral orthoses ( LSOs ) in the management of lower back pain ( LBP ) .
-OBJECTIVE	To evaluate the effects of two types of LSOs on self-rated disability in patients with LBP .
-BACKGROUND	LSOs are commonly used for the management of LBP , but their effectiveness may vary because of design .
-BACKGROUND	An inextensible LSO ( iLSO ) reduces trunk motion and increases trunk stiffness , whereas an extensible LSO ( eLSO ) does not .
-METHODS	A total of 98 participants with LBP were randomized to 3 groups : ( 1 ) standard care ( SC ) group , which included medication and physical therapy ( n = 29 ) , ( 2 ) SC with eLSO ( eLSO group ) ( n = 32 ) , and ( 3 ) SC with iLSO ( iLSO group ) ( n = 37 ) .
-METHODS	Outcome measures were evaluated before and after 2 weeks of treatment : modified Oswestry Disability Index ( ODI ) , Patient Specific Activity Scale , pain ratings , and Fear Avoidance Beliefs Questionnaire .
-RESULTS	There were no statistically significant differences between groups at baseline .
-RESULTS	Compared with the SC alone , iLSO group showed greater improvement on the ODI scores ( P = 0.01 ) but not the eLSO group .
-RESULTS	The ODI scores improved by a mean of 2.4 ( 95 % confidence interval [ CI ] , 2.2-7 .1 ) , 8.1 ( 95 % CI , 2.8-13 .4 ) , and 14.0 ( 95 % CI , 8.2-19 .8 ) points for SC , eLSO , and iLSO groups , respectively .
-RESULTS	Individuals wearing the iLSO had 4.7 times higher odds of achieving 50 % or greater improvement in the ODI scores than those assigned to SC ( 95 % CI , 1.2-18 .5 , P = 0.03 ) .
-RESULTS	Both the eLSO and iLSO groups had a greater improvement in the Patient Specific Activity Scale scores than the SC group ( P = .05 and P = 0.01 , respectively ) , but the change did not meet the minimal clinically important difference .
-RESULTS	Pain ratings improved for all 3 groups , with no statistical difference between them .
-RESULTS	Finally , no significant differences across groups were found for the Fear Avoidance Beliefs Questionnaire .
-CONCLUSIONS	An iLSO led to greater improvement in ODI scores than SC and an eLSO .
-CONCLUSIONS	We surmise that the likely mechanism responsible for this difference in outcome was the added trunk stiffness and motion restriction by the iLSO .
-METHODS	2 .
-
-###26072109
-BACKGROUND	Ixekizumab is a humanised monoclonal antibody against the proinflammatory cytokine interleukin 17A .
-BACKGROUND	We report two studies of ixekizumab compared with placebo or etanercept to assess the safety and efficacy of specifically targeting interleukin 17A in patients with widespread moderate-to-severe psoriasis .
-METHODS	In two prospective , double-blind , multicentre , phase 3 studies ( UNCOVER-2 and UNCOVER-3 ) , eligible patients were aged 18 years or older , had a confirmed diagnosis of chronic plaque psoriasis at least 6 months before baseline ( randomisation ) , 10 % or greater body-surface area involvement at both screening and baseline visits , at least a moderate clinical severity as measured by a static physician global assessment ( sPGA ) score of 3 or more , and a psoriasis area and severity index ( PASI ) score of 12 .
-METHODS	Participants were randomly assigned ( 1:2:2:2 ) by computer-generated random sequence with an interactive voice response system to receive subcutaneous placebo , etanercept ( 50 mg twice weekly ) , or one injection of 80 mg ixekizumab every 2 weeks , or every 4 weeks after a 160 mg starting dose .
-METHODS	Blinding was maintained with a double-dummy design .
-METHODS	Coprimary efficacy endpoints were proportions of patients achieving sPGA score 0 or 1 and 75 % or greater improvement in PASI at week 12 .
-METHODS	Analysis was by intention to treat .
-METHODS	These trials are registered with ClinicalTrials.gov , numbers NCT01597245 and NCT01646177 .
-RESULTS	Between May 30 , 2012 , and Dec 30 , 2013 , 1224 patients in UNCOVER-2 were randomly assigned to receive subcutaneous placebo ( n = 168 ) , etanercept ( n = 358 ) , or ixekizumab every 2 weeks ( n = 351 ) or every 4 weeks ( n = 347 ) ; between Aug 11 , 2012 , and Feb 27 , 2014 , 1346 patients in UNCOVER-3 were randomly assigned to receive placebo ( n = 193 ) , etanercept ( n = 382 ) , ixekizumab every 2 weeks ( n = 385 ) , or ixekizumab every 4 weeks ( n = 386 ) .
-RESULTS	At week 12 , both primary endpoints were met in both studies .
-RESULTS	For UNCOVER-2 and UNCOVER-3 respectively , in the ixekizumab every 2 weeks group , PASI 75 was achieved by 315 ( response rate 897 % ; [ effect size 874 % ( 975 % CI 829-918 ) vs placebo ; 481 % ( 412-550 ) vs etanercept ] ) and 336 ( 873 % ; [ 800 % ( 744-857 ) vs placebo ; 339 % ( 270-407 ) vs etanercept ] ) patients ; in the ixekizumab every 4 weeks group , by 269 ( 775 % ; [ 751 % ( 695-808 ) vs placebo ; 359 % ( 282-436 ) vs etanercept ] ) and 325 ( 842 % ; [ 769 % ( 710-828 ) vs placebo ; 308 % ( 237-379 ) vs etanercept ] ) patients ; in the placebo group , by four ( 24 % ) and 14 ( 73 % ) patients ; and in the etanercept group by 149 ( 416 % ) and 204 ( 534 % ) patients ( all p < 00001 vs placebo or etanercept ) .
-RESULTS	In the ixekizumab every 2 weeks group , sPGA 0/1 was achieved by 292 ( response rate 832 % ; [ effect size 808 % ( 975 % CI 756-860 ) vs placebo ; 472 % ( 399-544 ) vs etanercept ] ) and 310 ( 805 % ; [ 738 % ( 677-799 ) vs placebo ; 389 % ( 317-461 ) vs etanercept ] ) patients ; in the ixekizumab every 4 weeks group by 253 ( 729 % ; [ 705 % ( 646-765 ) vs placebo ; 369 % ( 291-447 ) vs etanercept ] ) and 291 ( 754 % ; [ 687 % ( 623-750 ) vs placebo ; 338 % ( 263-413 ) vs etanercept ] ) patients ; in the placebo group by four ( 24 % ) and 13 ( 67 % ) patients ; and in the etanercept group by 129 ( 360 % ) and 159 ( 416 % ) patients ( all p < 00001 vs placebo or etanercept ) .
-RESULTS	In combined studies , serious adverse events were reported in 14 ( 19 % ) of 734 patients given ixekizumab every 2 weeks , 14 ( 19 % ) of 729 given ixekizumab every 4 weeks , seven ( 19 % ) of 360 given placebo , and 14 ( 19 % ) of 739 given etanercept ; no deaths were noted .
-CONCLUSIONS	Both ixekizumab dose regimens had greater efficacy than placebo and etanercept over 12 weeks in two independent studies .
-CONCLUSIONS	These studies show that selectively neutralising interleukin 17A with a high affinity antibody potentially gives patients with psoriasis a new and effective biological therapy option .
-BACKGROUND	Eli Lilly and Co. .
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-###25540035
-BACKGROUND	Provoked vestibulodynia ( PVD ) , a frequent form of chronic genital pain , is associated with decreased sexual function for afflicted women , as well as impoverished sexual satisfaction for women and their partners .
-BACKGROUND	Pain and sexuality outcomes for couples with PVD are influenced by interpersonal factors , such as pain catastrophizing , partner responses to pain , ambivalence over emotional expression , attachment style and perceived relationship and sexual intimacy .
-BACKGROUND	Despite recommendations in the literature to include the partner in cognitive-behavioral therapy targeted at improving pain and sexuality outcomes , no randomized clinical trial has tested the efficacy of this type of intervention and compared it to a first-line medical intervention .
-METHODS	This bi-center , randomized clinical trial is designed to examine the efficacy of cognitive-behavioral couple therapy compared to topical lidocaine .
-METHODS	It is conducted across two Canadian university-hospital centers .
-METHODS	Eligible women diagnosed with PVD and their partners are randomized to one of the two interventions .
-METHODS	Evaluations are conducted using structured interviews and validated self-report measures at three time points : Pre-treatment ( T1 : prior to randomization ) , post-treatment ( T2 ) , and 6-month follow-up ( T3 ) .
-METHODS	The primary outcome is the change in reported pain during intercourse between T1 and T2 .
-METHODS	Secondary outcomes focus on whether there are significant differences between the two treatments at T2 and T3 on ( a ) the multidimensional aspects of women 's pain and ( b ) women and partners ' sexuality ( sexual function and satisfaction ) , psychological adjustment ( anxiety , depression , catastrophizing , self-efficacy , and quality of life ) , relationship factors ( partner responses and dyadic adjustment ) and self-reported improvement and treatment satisfaction .
-METHODS	In order to detect an effect size as small as 0.32 for secondary outcomes , a sample of 170 couples is being recruited ( 27 % dropout expected ) .
-METHODS	A clinically significant decrease in pain is defined as a 30 % reduction .
-CONCLUSIONS	The randomized clinical trial design is the most appropriate to examine the efficacy of cognitive-behavioral couple therapy , a recently developed and pilot-tested psychosocial intervention for couples coping with PVD , in comparison to a frequent first-line treatment option , topical lidocaine .
-CONCLUSIONS	Findings from this study will provide important information about empirically supported treatment options for PVD , and inform future treatment development and research for this patient population .
-BACKGROUND	Clinicaltrials.gov NCT01935063 ; registration date : 27 August 27 2013 .
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-###24827132
-BACKGROUND	At 42.5 months of median follow-up , PHARE failed to show that 6 was non-inferior to 12 months of adjuvant trastuzumab .
-BACKGROUND	From the results of PHARE , questions remain regarding whether the magnitude of benefit derived from 1 year is sufficient to justify its systematic use for different patient subgroups .
-METHODS	Treatment effects were evaluated according to various tumour characteristics , and the multivariate Cox proportional hazards regression models were carried out on metastases-free survival ( MFS ) in the 12 months control arm .
-METHODS	A prognostic score was defined providing the identification of patient categories with similar risks .
-METHODS	The 6-month arm was used as a validation set in order to test for heterogeneity .
-METHODS	This study is registered at clinicaltrials.gov , number NCT00381901 .
-RESULTS	A total of 261 metastatic events were observed and four prognostic groups were defined : very low , low , intermediate and high risk in the 12-month arm .
-RESULTS	The corresponding 3-year MFS rates were 98.3 % , 95.8 % , 90.4 % and 78.4 % in the four prognostic groups , respectively .
-RESULTS	In the 6-month arm , the 3-year MFS rates were 98.3 % , 94.2 % , 85.7 % and 74.8 % in the four prognostic groups , respectively .
-CONCLUSIONS	In the very low-risk group , the potential absolute benefit of standard duration of trastuzumab was small enough to indicate that optimal standard treatment might be clinically questionable .
-CONCLUSIONS	On the other hand , the 3-year metastasis occurrence rates strongly support the need for a search of a more efficient treatment in the low - , intermediate - and high-risk groups .
-
-###25847895
-OBJECTIVE	To compare the outcomes of shock wave lithotripsy ( SWL ) combined with inclined position and SWL alone in patients with lower pole calyx stones .
-METHODS	Seven hundred forty patients who underwent SWL treatment for lower pole renal stones with a total diameter of 2 cm or less were prospectively randomized into two groups .
-METHODS	They were comparable in terms of age , sex , and stone diameters .
-METHODS	Patients with lower calyceal stones ( 4-20 mm ) were randomized to SWL ( 368 patients ) or SWL with simultaneous inclination ( 372 patients ) with 30o head down Trendelenburg position ) .
-METHODS	Shock wave and session numbers were standardized according to stone size .
-METHODS	Additional standardized shock waves were given to patients with stone fragments determined by kidney urinary bladder film and ultrasound at weeks 1 , 4 , 10 .
-RESULTS	The overall stone free rate ( SFR ) was 73 % ( 268/368 ) in patients with SWL alone and 81 % ( 300/372 ) in SWL with inclination at the end of 12th week ( p = 0.015 ) .
-RESULTS	No significant adverse events were noted in both treatment groups .
-CONCLUSIONS	Simultaneous inclination of patients during SWL session increase SFR in lower caliceal stones significantly compared to SWL treatment alone .
-
-###25715353
-OBJECTIVE	To study the effects of zinc and steroid in the treatment of traumatic anosmia .
-METHODS	A prospective , randomized study .
-METHODS	Academic medical center .
-METHODS	Patients with a clear history of loss of smell after head injury and whose thresholds were -1 measured by the phenyl ethyl alcohol threshold test were included in this study from January 2010 to May 2013 .
-METHODS	They were randomly divided into 4 groups .
-METHODS	Patients in group 1 were treated with zinc gluconate for a month and high-dose prednisolone with tapering for 2 weeks .
-METHODS	Those in group 2 took only zinc gluconate , and those in group 3 took only prednisolone .
-METHODS	Patients in group 4 did not take any medicine .
-METHODS	All patients were followed up by phenyl ethyl alcohol threshold testing , and magnetic resonance imaging was performed to measure the volume of olfactory bulbs .
-RESULTS	Thirty-nine patients in group 1 , 35 in group 2 , 34 in group 3 , and 37 in group 4 completed the study .
-RESULTS	The recovery of olfactory function was observed in 11 patients ( 28.2 % ) in group 1 , in 9 ( 25.7 % ) in group 2 , in 4 ( 11.8 % ) in group 3 , and in 1 ( 2.7 % ) in group 4 .
-RESULTS	The recovery rates of olfactory function of groups 1 and 2 were significantly higher than the recovery rate of group 4 .
-RESULTS	The volume of olfactory bulbs was not significantly different between those with and without improved olfactory function .
-CONCLUSIONS	Our results show that zinc gluconate has a promising effect in treating traumatic anosmia .
-
-###24359432
-BACKGROUND	Diabetes mellitus is an increasingly prevalent metabolic disorder that is associated with substantial disease burden .
-BACKGROUND	Australia has an opportunity to improve ways of caring for the growing number of people with diabetes , but this may require changes to the way care is funded , organised and delivered .
-BACKGROUND	To inform how best to care for people with diabetes , and to identify the extent of change that is required to achieve this , the Diabetes Care Project ( DCP ) will evaluate the impact of two different , evidence-based models of care ( compared to usual care ) on clinical quality , patient and provider experience , and cost .
-METHODS	The DCP uses a pragmatic , cluster randomised controlled trial design .
-METHODS	Accredited general practices that are situated within any of the seven Australian Medicare Locals/Divisions of General Practice that have agreed to take part in the study were invited to participate .
-METHODS	Consenting practices will be randomly assigned to one of three treatment groups for approximately 18 to 22 months : ( a ) control group ( usual care ) ; ( b ) Intervention 1 ( which tests improvements that could be made within the current funding model , facilitated through the use of an online chronic disease management network ) ; or ( c ) Intervention 2 ( which includes the same components as Intervention 1 , as well as altered funding to support voluntary patient registration with their practice , incentive payments and a care facilitator ) .
-METHODS	Adult patients who attend the enrolled practices and have established ( 12 month 's duration ) type 1 diabetes mellitus or newly diagnosed or established type 2 diabetes mellitus are invited to participate .
-METHODS	Multiple outcomes will be studied , including changes in glycosylated haemoglobin ( primary outcome ) , changes in other biochemical and clinical metrics , incidence of diabetes-related complications , quality of life , clinical depression , success of tailored care , patient and practitioner satisfaction , and budget sustainability .
-CONCLUSIONS	This project responds to a need for robust evidence of the clinical and economic effectiveness of coordinated care for the management of diabetes in the Australian primary care setting .
-CONCLUSIONS	The outcomes of the study will have implications not only for diabetes management , but also for the management of other chronic diseases , both in Australia and overseas .
-BACKGROUND	Australian New Zealand Clinical Trials Registry ( ACTRN12612000363886 ) ; World Health Organisation ( U1111-1128-0481 ) .
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-###24297959
-OBJECTIVE	To investigate and compare the effects of superelastic nickel-titanium and multistranded stainless steel archwires on pain during the initial phase of orthodontic treatment .
-METHODS	A double-blind two-arm parallel design stratified randomized clinical trial .
-METHODS	A single centre in India between December 2010 and June 2012 .
-METHODS	A total of 96 participants ( 48 male and 48 females ; 14.12.1 years old ) were randomized ( stratified on age , sex and initial crowding ) to superelastic nickel-titanium or multistranded stainless steel archwire groups using a computer-generated allocation sequence .
-METHODS	We compared 0.016-inch superelastic nickel-titanium and 0.0175-inch multistranded stainless steel wires in 0.022-inch slot ( Roth prescription ) preadjusted edgewise appliances .
-METHODS	The follow-up period was 14 days .
-METHODS	Outcome was assessed with a visual analogue scale at baseline and 32 pre-specified follow-up points .
-METHODS	Data was analyzed using mixed-effects model analysis .
-RESULTS	One participant was lost to follow up and 10 were excluded from the analysis due to bond failure or incomplete questionnaire answers .
-RESULTS	Ultimately , 85 participants ( 42 males and 43 females ; 14.12.0 years old ) were analysed for the final results .
-RESULTS	No statistically significant difference was found for overall pain [ F value = 2.65 , degrees of freedom ( df ) = 92.6 ; P = 0.1071 ] .
-RESULTS	However , compared to multistranded stainless steel wires , pain in subjects with superelastic nickel-titanium archwires was significantly greater at 12 h ( t = 2.34 ; P = 0.0193 ) , as well as at day 1 in the morning ( t = 2.21 , P = 0.0273 ) , afternoon ( t = 2.11 , P = 0.0346 ) and at bedtime ( t = 2.03 , P = 0.042 ) .
-CONCLUSIONS	For overall pain , there was no statistically significant difference between the two wires .
-CONCLUSIONS	However , subjects with superelastic nickel-titanium archwires had a significantly higher pain at peak level .
-
-###25457926
-OBJECTIVE	Neurodevelopmental theories of psychosis highlight the potential benefits of early intervention , prevention , and/or preemption .
-OBJECTIVE	How early intervention should take place has not been established , nor whether interventions based on social learning principles can have preemptive effects .
-OBJECTIVE	The objective was to test whether a comprehensive psychosocial intervention can significantly alter psychotic symptom trajectories during adolescence-a period of heightened risk for a wide range of psychopathology .
-METHODS	This study was a randomized controlled trial ( RCT ) of Multidimensional Treatment Foster Care ( MTFC ) for delinquent adolescent girls .
-METHODS	Assessment of psychotic symptoms took place at baseline and then 6 , 12 , 18 , and 24 months post-baseline using a standardized self-report instrument ( Brief Symptom Inventory ) .
-METHODS	A second source of information about psychotic symptoms was obtained at baseline or 12 months , and again at 24 months using a structured diagnostic interview ( the Diagnostic Interview Schedule for Children [ DISC ] ) .
-RESULTS	Significant benefits for MTFC over treatment as usual for psychosis symptoms were observed over a 24-month period .
-RESULTS	Findings were replicated across both measures .
-RESULTS	Effects were independent of substance use and initial symptom severity and persisted beyond the initial intervention period .
-CONCLUSIONS	Ameliorating nonclinical psychotic symptoms trajectories beginning in mid-adolescence via a multifaceted psychosocial intervention is possible .
-CONCLUSIONS	Developmental research on nonclinical psychotic symptoms and their prognostic value should be complemented by more psychosocial intervention research aimed at modifying these symptom trajectories early in their natural history .
-CONCLUSIONS	Clinical trial registration information-Juvenile Justice Girls Randomized Control Trial : Young Adult Follow-up ; http://clinicaltrials.gov; NCT01341626 .
-
-###24722496
-OBJECTIVE	INT131 besylate is a potent , nonthiazolidinedione , selective peroxisome proliferator-activated receptor ( PPAR ) modulator ( SPPARM ) designed to improve glucose metabolism while minimizing the side effects of full PPAR agonists .
-OBJECTIVE	This placebo-controlled study compared the efficacy and side effects of INT131 besylate versus 45 mg pioglitazone HCl in subjects with type 2 diabetes ( T2D ) .
-METHODS	This was a 24-week randomized , double-blind , placebo - and active-controlled study of 0.5-3 .0 mg INT131 versus 45 mg pioglitazone or placebo daily in 367 subjects with T2D on sulfonylurea or sulfonylurea plus metformin .
-METHODS	The primary efficacy analysis was the comparison of change from baseline to week 24 in hemoglobin A1c ( HbA1c ) across treatment groups .
-METHODS	Fluid status was assessed with a prospective scoring system for lower-extremity pitting edema .
-RESULTS	INT131 had a steep dose response for efficacy as measured by changes in HbA1c .
-RESULTS	After 24 weeks ' treatment , the 0.5-mg dose demonstrated minimal efficacy ( HbA1c -0.3 0.12 % ) and the 2-mg dose demonstrated near-maximal efficacy ( HbA1c -1.1 0.12 % ) , which was not statistically different from the efficacy of 45 mg pioglitazone ( HbA1c -0.9 0.12 % ; P < 0.01 for noninferiority ) .
-RESULTS	With the 1-mg dose , INT131 provided significant improvements in glycemic control ( HbA1c 0.8 0.12 ; P < 0.001 vs. placebo ) but with less edema , weight gain , and hemodilution than observed with 45 mg pioglitazone .
-CONCLUSIONS	INT131 demonstrated dose-dependent reductions in HbA1c , equivalent to 45 mg pioglitazone , but with less fluid accumulation and weight gain , consistent with its SPPARM design .
-
-###25007091
-METHODS	HIV-1 vaccine development has advanced slowly due to viral antigenic diversity , poor immunogenicity and recently , safety concerns associated with human adenovirus serotype-5 vectors .
-METHODS	To tackle HIV-1 variation , we designed a unique T-cell immunogen HIVconsv from functionally conserved regions of the HIV-1 proteome , which were presented to the immune system using a heterologous prime-boost combination of plasmid DNA , a non-replicating simian ( chimpanzee ) adenovirus ChAdV-63 and a non-replicating poxvirus , modified vaccinia virus Ankara .
-METHODS	A block-randomized , single-blind , placebo-controlled phase I trial HIV-CORE 002 administered for the first time candidate HIV-1 - vaccines or placebo to 32 healthy HIV-1 / 2-uninfected adults in Oxford , UK and elicited high frequencies of HIV-1-specific T cells capable of inhibiting HIV-1 replication in vitro .
-METHODS	Here , detail safety and tolerability of these vaccines are reported .
-METHODS	Local and systemic reactogenicity data were collected using structured interviews and study-specific diary cards .
-METHODS	Data on all other adverse events were collected using open questions .
-METHODS	Serum neutralizing antibody titres to ChAdV-63 were determined before and after vaccination .
-RESULTS	Two volunteers withdrew for vaccine-unrelated reasons .
-RESULTS	No vaccine-related serious adverse events or reactions occurred during 190 person-months of follow-up .
-RESULTS	Local and systemic events after vaccination occurred in 27/32 individuals and most were mild ( severity grade 1 ) and predominantly transient ( < 48 hours ) .
-RESULTS	Myalgia and flu-like symptoms were more strongly associated with MVA than ChAdV63 or DNA vectors and more common in vaccine recipients than in placebo .
-RESULTS	There were no intercurrent HIV-1 infections during follow-up .
-RESULTS	2/24 volunteers had low ChAdV-63-neutralizing titres at baseline and 7 increased their titres to over 200 with a median ( range ) of 633 ( 231-1533 ) post-vaccination , which is of no safety concern .
-CONCLUSIONS	These data demonstrate safety and good tolerability of the pSG2.HIVconsv DNA , ChAdV63.HIVconsv and MVA.HIVconsv vaccines and together with their high immunogenicity support their further development towards efficacy studies .
-BACKGROUND	ClinicalTrials.gov NCT01151319 .
-
-###25304191
-BACKGROUND	Low levels of health-enhancing physical activity require novel approaches that have the potential to reach broad populations .
-BACKGROUND	Web-based interventions are a popular approach for behaviour change given their wide reach and accessibility .
-BACKGROUND	However , challenges with participant engagement and retention reduce the long-term maintenance of behaviour change .
-BACKGROUND	Web 2.0 features present a new and innovative online environment supporting greater interactivity , with the potential to increase engagement and retention .
-BACKGROUND	In order to understand the applicability of these innovative interventions for the broader population , ` real-world ' interventions implemented under ` everyday conditions ' are required .
-BACKGROUND	The aim of this study is to investigate the difference in physical activity behaviour between individuals using a traditional Web 1.0 website with those using a novel Web 2.0 website .
-METHODS	In this study we will aim to recruit 2894 participants .
-METHODS	Participants will be recruited from individuals who register with a pre-existing health promotion website that currently provides Web 1.0 features ( http://www.10000steps.org.au ) .
-METHODS	Eligible participants who provide informed consent will be randomly assigned to one of the two trial conditions : the pre-existing 10000 Steps website ( with Web 1.0 features ) or the newly developed WALK 2.0 website ( with Web 2.0 features ) .
-METHODS	Primary and secondary outcome measures will be assessed by self-report at baseline , 3months and 12months , and include : physical activity behaviour , height and weight , Internet self-efficacy , website usability , website usage and quality of life .
-BACKGROUND	This study has received ethics approval from the University of Western Sydney Human Research Ethics Committee ( Reference Number H8767 ) and has been funded by the National Health and Medical Research Council ( Reference Number 589903 ) .
-BACKGROUND	Study findings will be disseminated widely through peer-reviewed publications , academic conferences and local community-based presentations .
-BACKGROUND	Australian New Zealand Clinical Trials Registry Number : ACTRN12611000253909 , WHO Universal Trial Number : U111-1119-1755 .
-
-###24679401
-BACKGROUND	Research suggests that people with bipolar disorder may be highly motivated to attain dominance and may over-estimate their social power ( Johnson and Carver , 2012 ) .
-BACKGROUND	This manic temperament may provide an adaptive advantage in the pursuit of dominance and leadership ( Akiskal and Akiskal , 1992 ) .
-BACKGROUND	It was hypothesized that people at high risk for bipolar disorder , as defined by the Hypomanic Personality Scale ( HPS ) , would fail to assume a submissive role when it was appropriate to do so .
-METHODS	Participants ( 81 undergraduates ) completed an image description task with a confederate .
-METHODS	Participants were randomly assigned to interact with a confederate who assumed one of three nonverbal postures : dominant ( expanded ) , neutral , or submissive ( constricted ) .
-METHODS	Nonverbal dominance behavior was defined as the rate at which participants expanded their body span during the task .
-RESULTS	Consistent with hypotheses , an ANOVA indicated an interaction of Mania risk x Dominance condition on body expansion .
-RESULTS	Whereas participants with low mania risk ( HPS scores ) adapted complementary behavior in response to the confederate , participants with high mania risk demonstrated a consistently dominant ( expanded ) nonverbal posture .
-CONCLUSIONS	A major limitation of this study is the use of an analog measure of mania risk in place of clinical diagnoses .
-CONCLUSIONS	In this experiment , participants at high risk for mania maintained a dominant posture even when submissiveness would have been more appropriate .
-CONCLUSIONS	It is argued that persistent dominance behavior may play an important role in the interpersonal interactions of individuals at risk for bipolar disorder .
-
-###25624374
-BACKGROUND	Inadequate designs and conflicting results from previous studies prompted the US Food and Drug Administration to publish guidelines for the design of clinical trials evaluating the effects of orally inhaled and intranasal corticosteroids on the growth of children .
-BACKGROUND	This study conformed to these guidelines to evaluate the effect of triamcinolone acetonide aqueous nasal spray ( TAA-AQ ) on the growth of children with perennial allergic rhinitis ( PAR ) .
-METHODS	This randomized , double-blind , placebo-controlled , parallel-group , multicenter study evaluated the effect of once-daily TAA-AQ ( 110 g ) on the growth velocity ( GV ) of children aged 3-9 years with PAR by using stadiometry at baseline ( 4-6 months ) , during treatment ( 12 months ) , and at follow-up ( 2 months ) .
-METHODS	Hypothalamus-pituitary-adrenal ( HPA ) axis function was assessed by measuring urinary cortisol levels .
-METHODS	Details of adverse events were recorded .
-RESULTS	Of 1078 subjects screened , 299 were randomized , and 216 completed the study ( placebo , 107 ; TAA-AQ , 109 ) .
-RESULTS	In the primary analysis ( modified intent-to-treat : placebo , 133 ; TAA-AQ , 134 ) , least-squares mean GV during treatment was lower in the TAA-AQ group ( 5.65 cm/year ) versus placebo ( 6.09 cm/year ) .
-RESULTS	The difference ( -0.45 cm/year ; 95 % confidence interval : -0.78 to -0.11 ; P = .01 ) , although clinically nonsignificant , was evident within 2 months of treatment and stabilized thereafter .
-RESULTS	At follow-up , the GV approached baseline ( 6.70 cm/year ) in the TAA-AQ group ( 6.59 cm/year ) and decreased slightly in the placebo group ( 5.89 cm/year vs 6.06 cm/year at baseline ) .
-RESULTS	No HPA axis suppression was observed .
-CONCLUSIONS	By using rigorous Food and Drug Administration-recommended design elements , this study detected a small , statistically significant effect of TAA-AQ on the GV of children with PAR .
-
-###25020061
-OBJECTIVE	Fasting is characterised by profound changes in energy metabolism including progressive loss of body proteins .
-OBJECTIVE	The underlying mechanisms are however unknown and we therefore determined the effects of a 72-hour-fast on human skeletal muscle protein metabolism and activation of mammalian target of rapamycin ( mTOR ) , a key regulator of cell growth .
-METHODS	Eight healthy male volunteers were studied twice : in the postabsorptive state and following 72 hours of fasting .
-METHODS	Regional muscle amino acid kinetics was measured in the forearm using amino acid tracers .
-METHODS	Signaling to protein synthesis and breakdown were assessed in skeletal muscle biopsies obtained during non-insulin and insulin stimulated conditions on both examination days .
-RESULTS	Fasting significantly increased forearm net phenylalanine release and tended to decrease phenylalanine rate of disappearance .
-RESULTS	mTOR phosphorylation was decreased by 50 % following fasting , together with reduced downstream phosphorylation of 4EBP1 , ULK1 and rpS6 .
-RESULTS	In addition , the insulin stimulated increase in mTOR and rpS6 phosphorylation was significantly reduced after fasting indicating insulin resistance in this part of the signaling pathway .
-RESULTS	Autophagy initiation is in part regulated by mTOR through ULK1 and fasting increased expression of the autophagic marker LC3B-II by 30 % .
-RESULTS	p62 is degraded during autophagy but was increased by 10 % during fasting making interpretation of autophagic flux problematic .
-RESULTS	MAFbx and MURF1 ubiquitin ligases remained unaltered after fasting indicating no change in protesomal protein degradation .
-CONCLUSIONS	Our results show that during fasting increased net phenylalanine release in skeletal muscle is associated to reduced mTOR activation and concomitant decreased downstream signaling to cell growth .
-
-###24797376
-OBJECTIVE	To evaluate the efficacy of IV iron supplementation of anemic , critically ill trauma patients .
-METHODS	Multicenter , randomized , single-blind , placebo-controlled trial .
-METHODS	Four trauma ICUs .
-METHODS	Anemic ( hemoglobin < 12g/dL ) trauma patients enrolled within 72 hours of ICU admission and with an expected ICU length of stay of more than or equal to 5 days .
-METHODS	Randomization to iron sucrose 100mg IV or placebo thrice weekly for up to 2 weeks .
-RESULTS	A total of 150 patients were enrolled .
-RESULTS	Baseline iron markers were consistent with functional iron deficiency : 134 patients ( 89.3 % ) were hypoferremic , 51 ( 34.0 % ) were hyperferritinemic , and 64 ( 42.7 % ) demonstrated iron-deficient erythropoiesis as evidenced by an elevated erythrocyte zinc protoporphyrin concentration .
-RESULTS	The median baseline transferrin saturation was 8 % ( range , 2-58 % ) .
-RESULTS	In the subgroup of patients who received all six doses of study drug ( n = 57 ) , the serum ferritin concentration increased significantly for the iron as compared with placebo group on both day 7 ( 808.0 ng/mL vs 457.0 ng/mL , respectively , p < 0.01 ) and day 14 ( 1,046.0 ng/mL vs 551.5 ng/mL , respectively , p < 0.01 ) .
-RESULTS	There was no significant difference between groups in transferrin saturation , erythrocyte zinc protoporphyrin concentration , hemoglobin concentration , or packed RBC transfusion requirement .
-RESULTS	There was no significant difference between groups in the risk of infection , length of stay , or mortality .
-CONCLUSIONS	Iron supplementation increased the serum ferritin concentration significantly , but it had no discernible effect on transferrin saturation , iron-deficient erythropoiesis , hemoglobin concentration , or packed RBC transfusion requirement .
-CONCLUSIONS	Based on these data , routine IV iron supplementation of anemic , critically ill trauma patients can not be recommended ( NCT 01180894 ) .
-
-###24682346
-BACKGROUND	Allogeneic mesenchymal precursor cells ( MPCs ) injected during left ventricular assist device ( LVAD ) implantation may contribute to myocardial recovery .
-BACKGROUND	This trial explores the safety and efficacy of this strategy .
-RESULTS	In this multicenter , double-blind , sham-procedure controlled trial , 30 patients were randomized ( 2:1 ) to intramyocardial injection of 25 million MPCs or medium during LVAD implantation .
-RESULTS	The primary safety end point was incidence of infectious myocarditis , myocardial rupture , neoplasm , hypersensitivity reaction , and immune sensitization ( 90 days after randomization ) .
-RESULTS	Key efficacy end points were functional status and ventricular function while temporarily weaned from LVAD support ( 90 days after randomization ) .
-RESULTS	Patients were followed up until transplant or 12 months after randomization , whichever came first .
-RESULTS	Mean age was 57.4 ( 13.6 ) years , mean left ventricular ejection fraction was 18.1 % , and 66.7 % were destination therapy LVADs .
-RESULTS	No safety events were observed .
-RESULTS	Successful temporary LVAD weaning was achieved in 50 % of MPC and 20 % of control patients at 90 days ( P = 0.24 ) ; the posterior probability that MPCs increased the likelihood of successful weaning was 93 % .
-RESULTS	At 90 days , 3 deaths ( 30 % ) occurred in control patients , and none occurred in MPC patients .
-RESULTS	Mean left ventricular ejection fraction after successful wean was 24.0 % ( MPC = 10 ) and 22.5 % ( control = 2 ; P = 0.56 ) .
-RESULTS	At 12 months , 30 % of MPC patients and 40 % of control patients were successfully temporarily weaned from LVAD support ( P = 0.69 ) , and 6 deaths ( 30 % ) occurred in MPC patients .
-RESULTS	Donor-specific HLA sensitization developed in 2 MPC and 3 control patients and resolved by 12 months .
-CONCLUSIONS	In this preliminary trial , administration of MPCs appeared to be safe , and there was a potential signal of efficacy .
-CONCLUSIONS	Future studies will evaluate the potential for higher or additional doses to enhance the ability to wean LVAD recipients off support .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT01442129 .
-
-###25248910
-OBJECTIVE	Efforts to reduce disparities in recurrent stroke among Black and Latino stroke survivors have met with limited success .
-OBJECTIVE	We aimed to determine the effect of peer education on secondary stroke prevention among predominantly minority stroke survivors .
-METHODS	Between 2009 and 2012 , we enrolled 600 stroke or transient ischemic attack survivors from diverse , low-income communities in New York City into a 2-arm randomized clinical trial that compared a 6 week ( 1 session/week ) , peer-led , community-based , stroke prevention self-management group workshop ( N = 301 ) to a wait-list control group ( N = 299 ) .
-METHODS	The primary outcome was the proportion with a composite of controlled blood pressure ( < 140/90 mm Hg ) , low-density lipoprotein cholesterol < 100 mg/dL , and use of antithrombotic medications at 6 months .
-METHODS	Secondary outcomes included control of the individual stroke risk factors .
-METHODS	All analyses were by intent-to-treat .
-RESULTS	There was no difference in the proportion of intervention and control group participants achieving the composite outcome ( 34 % versus 34 % ; P = 0.98 ) .
-RESULTS	The proportion with controlled blood pressure at 6 months was greater in the intervention group than in the control group ( 76 % versus 67 % ; P = 0.02 ) .
-RESULTS	This corresponded to a greater change in systolic blood pressure in the intervention versus control group ( -3.63 SD , 19.81 mm Hg versus +0.34 SD , 23.76 mm Hg ; P = 0.04 ) .
-RESULTS	There were no group differences in the control of cholesterol or use of antithrombotics .
-CONCLUSIONS	A low-cost peer education self-management workshop modestly improved blood pressure , but not low-density lipoprotein cholesterol or antithrombotic use , among stroke and transient ischemic attack survivors from vulnerable , predominantly minority urban communities .
-BACKGROUND	http://www.clinicaltrials.gov/show/NCT0102727 .
-BACKGROUND	Unique identifier : NCT01027273 .
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-###24850107
-BACKGROUND	Despite 30 years of clinical research , we still do not know the optimal dose of intrathecal morphine ( ITM ) when used alone .
-OBJECTIVE	A safety investigation and comparison of the analgesic efficacy of ITM 0.2 mg , 0.5 mg , and 1 mg in patients undergoing major abdominal cancer surgery .
-METHODS	A randomized , double-blind trial .
-METHODS	Academic medical center .
-METHODS	Ninety patients were randomly assigned to receive morphine intrathecally either 0.2 mg ( Group I , ITM 0.2 mg , n = 30 ) , 0.5 mg ( Group II , ITM 0.5 mg , n = 30 ) , or 1 mg ( Group III , ITM 1 mg , n = 30 ) dissolved in 5 mL physiological saline before general anesthesia .
-METHODS	Assessment parameters included hemodynamics , respiratory rate , peripheral arterial oxygenation , sedation score , pain severity , time of first analgesic request , total analgesic consumption , and side effects in the first 72 hours .
-RESULTS	The mean time to first request for rescue analgesia was significantly prolonged in Group II ( 22.13 5.21 hours , P < 0.001 ) and Group III ( 30.83 4.89 h , P < 0.001 ) , compared with Group I ( 0.50 0.66 hours ) .
-RESULTS	The mean tramadol consumption dose was significantly reduced in Group II ( 383.33 91.28 mg , P < 0.001 ) and Group III ( 300 69.48 mg , P < 0.001 ) compared with Group I ( 770 114.92 mg ) .
-RESULTS	Patients received 1 mg ITM showed lower VAS scores in the first 48 h postoperative ( P < 0.04 ) compared with Group I and Group II .
-RESULTS	No significant differences were observed in the mean systolic and diastolic blood pressure values , respiratory rate , and peripheral arterial oxygen saturation between groups .
-RESULTS	Lower mean heart rate values were observed in Group III patients at 6 hours ( P < 0.01 ) and 12 hours ( P < 0.03 ) postoperative compared with Group I and Group II patients .
-RESULTS	Six patients ( 20 % ) in Group II and 8 ( 26.7 % ) in Group III exhibited pruritus compared with 2 patients ( 6.66 % ) in Group I ( P < 0.01 ) .
-RESULTS	No intergroup statistical differences were observed for other studied side effects .
-CONCLUSIONS	This study is limited by its small sample size .
-CONCLUSIONS	One mg ITM provided superior analgesia for 48 hours postoperative compared with 0.2 mg and 0.5 mg ITM with a nonsignificant difference in the incidence of side effects .
-CONCLUSIONS	Further studies of larger sample size are recommended to confirm these findings .
-
-###25616289
-OBJECTIVE	To study the efficacy of Huai Qi Huang granules in the treatment of childhood primary nephrotic syndrome .
-METHODS	Between July 2009 and December 2011 , patients who were admitted and diagnosed for the first time as childhood primary nephrotic syndrome were randomized into a treatment group ( Huai Qi Huang granules plus glucocorticoid ; n = 23 ) and a control group ( glucocorticoid alone ; n = 19 ) for a prospective study .
-METHODS	The two groups were compared for regression time of edema , time to urinary protein clearance , relapse rate , incidence of infection , dosage of glucocorticoid , and humoral and cellular immunological indicators .
-RESULTS	There were no significant differences in regression time of edema , time to urinary protein clearance , and relapse rate between the treatment and control groups ( P > 0.05 ) .
-RESULTS	The treatment group had significantly lower incidence of infection and daily dose of glucocorticoid ( at month 6 ) than the control group ( P < 0.05 ) .
-RESULTS	Humoral and cellular immunological indicators showed no significant differences between the two groups ( P > 0.05 ) .
-RESULTS	No Huai Qi Huang-related adverse events were observed in this study .
-CONCLUSIONS	Huai Qi Huang granules treatment can reduce the dose of glucocorticoid and the incidence of infection in children with primary nephrotic syndrome and has a favourable safety .
-
-###25323890
-OBJECTIVE	Bowel cleansing is generally regarded as time-consuming and unpleasant among patients .
-OBJECTIVE	Patients commonly state that bowel preparation provokes more discomfort than the actual colonoscopic examination .
-OBJECTIVE	The purpose of this study was to compare two regimens of sodium phosphate ( NaP ) tablets versus polyethylene glycol ( PEG ) solution for bowel preparation in healthy Korean adults .
-METHODS	This was a single center , prospective , open-label , investigator-blinded , randomized , controlled-pilot study .
-METHODS	A total of 62 healthy Korean subjects were randomly assigned to two groups ( NaP vs. PEG ) .
-METHODS	Efficacy , safety , and patient-related outcomes , as well as procedural parameters , were evaluated .
-RESULTS	Although there were no significant differences in total Ottawa bowel quality score , fluid scores and the rate of adequate bowel preparation were significantly better in the NaP group than the PEG group .
-RESULTS	Additionally , the NaP group showed better results regarding patient tolerance , satisfaction , preference , and rate of adverse events than the PEG group .
-RESULTS	Significant fluctuations in specific serum electrolytes were common and of a greater magnitude in the NaP group than the PEG group .
-RESULTS	However , these abnormalities were transient and did not result in serious complications and side effects .
-CONCLUSIONS	In this study , NaP tablets were shown to be an effective , well-tolerated , and acceptable regimen for bowel preparation .
-CONCLUSIONS	Also , our study suggests that NaP tablets may be safe and can be used as a bowel cleansing agent in healthy adults undergoing elective colonoscopy .
-CONCLUSIONS	Further multicenter , large scale studies are needed to confirm these findings .
-
-###24646123
-BACKGROUND	Nepal is on track to achieve MDG 5 but there is a huge sub-national disparity with existing high maternal mortality in western and hilly regions .
-BACKGROUND	The national priority is to reduce this disparity to achieve the goal at sub-national level .
-BACKGROUND	Evidences from developing countries show that increasing utilization of skilled attendant at birth is an important indicator for reducing maternal death .
-BACKGROUND	Further , there is a very low utilization during childbirth in western and hilly regions of Nepal which clearly depicts the barriers in utilization of skilled birth attendants .
-BACKGROUND	So , there is a need to overcome the identified barriers to increase the utilization thereby decreasing the maternal mortality .
-BACKGROUND	The hypothesis of this study is that through a package of interventions the utilization of skilled birth attendants will be increased and hence improve maternal health in Nepal .
-METHODS	This study involves a cluster randomized controlled trial involving approximately 5000 pregnant women in 36 clusters .
-METHODS	The 18 intervention clusters will receive the following interventions : i ) mobilization of family support for pregnant women to reach the health facility , ii ) availability of emergency funds for institutional childbirth , iii ) availability of transport options to reach a health facility for childbirth , iv ) training to health workers on communication skills , v ) security provisions for SBAs to reach services 24/24 through community mobilization ; 18 control clusters will not receive the intervention package .
-METHODS	The final evaluation of the intervention is planned to be completed by October 2014 .
-METHODS	Primary study output of this study is utilization of SBA services .
-METHODS	Secondary study outputs measure the uptake of antenatal care , post natal checkup for mother and baby , availability of transportation for childbirth , operation of emergency fund , improved reception of women at health services , and improved physical security of SBAs .
-CONCLUSIONS	The intervention package is designed to increase the utilization of skilled birth attendants by overcoming the barriers related to awareness , finance , transport , security etc. .
-CONCLUSIONS	If proven effective , the Ministry of Health has committed to scale up the intervention package throughout the country .
-BACKGROUND	ISRCTN78892490 .
-
-###25259787
-BACKGROUND	Progressive midlife weight gain is associated with multiple adverse health outcomes and may represent an early manifestation of insulin resistance in a distinct subset of women .
-BACKGROUND	Emerging data implicate hyperinsulinema as a proximate cause of weight gain and support strategies that attenuate insulin secretion .
-OBJECTIVE	To assess a previously reported novel hypocaloric carbohydrate modified diet alone ( D ) , and in combination with metformin ( M ) and metformin plus low-dose rosiglitazone ( MR ) , in diverse women with midlife weight gain ( defined as > 20lbs since the twenties ) , normal glucose tolerance , and hyperinsulinemia .
-METHODS	46 women , mean age 46.61.0 , BMI 30.50.04 kg/m2 , 54.5 % white , 22.7 % black , 15.9 % Hispanic , at 2 university medical centers .
-METHODS	A dietary intervention designed to reduce insulin excursions was implemented in 4 weekly nutritional group workshops prior to randomization .
-METHODS	Change in 6-month fasting insulin .
-METHODS	Pre-specified secondary outcomes were changes in body weight , HOMA-IR , metabolic syndrome ( MS ) measures , leptin , and adiponectin .
-RESULTS	Six-month fasting insulin declined significantly in the M group : 12.5 to 8.0 U/ml , p = .026 .
-RESULTS	Mean 6-month weight decreased significantly and comparably in D , M , and MR groups : 4.7 , 5.4 , and 5.5 % ( p 's .049 , .002 , and .032 ) .
-RESULTS	HOMA-IR decreased in M and MR groups ( 2.5 to 1.6 and 1.9 to 1.3 , p 's = .054 , .013 ) .
-RESULTS	Additional improvement in MS measures included reduced waist circumference in D and MR groups and increased HDL in the D and M groups .
-RESULTS	Notably , mean fasting leptin did not decline in a subset of subjects with weight loss ( 26.152.01 ng/ml to 25.992.61 ng/ml , p = .907 .
-RESULTS	Adiponectin increased significantly in the MR group ( 11.11.0 to 18.57.4 , p < .001 ) Study medications were well tolerated .
-CONCLUSIONS	These findings suggest that EMPOWIR 's easily implemented dietary interventions , alone and in combination with pharmacotherapies that target hyperinsulinemia , merit additional investigation in larger , long-term studies .
-BACKGROUND	ClinicalTrials.gov NCT00618072 .
-
-###24597650
-BACKGROUND	Virtual reality ( VR ) is not commonly used in clinical rehabilitation , and commercial VR gaming systems may have mixed effects in patients with stroke .
-BACKGROUND	Therefore , we developed RehabMaster , a task-specific interactive game-based VR system for post-stroke rehabilitation of the upper extremities , and assessed its usability and clinical efficacy .
-METHODS	A participatory design and usability tests were carried out for development of RehabMaster with representative user groups .
-METHODS	Two clinical trials were then performed .
-METHODS	The first was an observational study in which seven patients with chronic stroke received 30 minutes of RehabMaster intervention per day for two weeks .
-METHODS	The second was a randomised controlled trial of 16 patients with acute or subacute stroke who received 10 sessions of conventional occupational therapy only ( OT-only group ) or conventional occupational therapy plus 20 minutes of RehabMaster intervention ( RehabMaster + OT group ) .
-METHODS	The Fugl-Meyer Assessment score ( FMA ) , modified Barthel Index ( MBI ) , adverse effects , and drop-out rate were recorded .
-RESULTS	The requirements of a VR system for stroke rehabilitation were established and incorporated into RehabMaster .
-RESULTS	The reported advantages from the usability tests were improved attention , the immersive flow experience , and individualised intervention .
-RESULTS	The first clinical trial showed that the RehabMaster intervention improved the FMA ( P = .03 ) and MBI ( P = .04 ) across evaluation times .
-RESULTS	The second trial revealed that the addition of RehabMaster intervention tended to enhance the improvement in the FMA ( P = .07 ) but did not affect the improvement in the MBI .
-RESULTS	One patient with chronic stroke left the trial , and no adverse effects were reported .
-CONCLUSIONS	The RehabMaster is a feasible and safe VR system for enhancing upper extremity function in patients with stroke .
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-###25481364
-OBJECTIVE	The volume of a fibroid uterus before performing hysterectomy is typically estimated through bimanual examination and confirmed by ultrasonography .
-OBJECTIVE	This study compares estimated volumes by bimanual examination and ultrasound examination with MRI and actual volumes obtained from histopathology , as gold standards .
-METHODS	We used data from a previous prospective randomized multi-center trial that compared hysterectomy and uterine artery embolization ( UAE ) for the treatment of symptomatic fibroids .
-METHODS	All patients underwent bimanual vaginal examination and pelvic ultrasonography .
-METHODS	Those women randomized to UAE received a pelvic MRI .
-METHODS	For women randomized to hysterectomy , the exact uterine volume was based on histopathologic examination .
-METHODS	We compared the calculated volumes based on ultrasound parameters and estimated volume based on bimanual examination with either the calculated volumes of the pelvic MRI parameters or the calculated volume based on the exact weight during histological examinations .
-RESULTS	Our study demonstrated poor agreement between ultrasound and bimanual examination compared with exact volume during histopathologic examination and MRI-based volume .
-RESULTS	The agreement within the patient group with uterine volume > 233 g and > 747 g was fair to good .
-RESULTS	For those women with a uterine volume between 233 and 747 g , the agreement was poor when comparing bimanual estimates with volume obtained from MRI or histolopathologic examination .
-RESULTS	Within this volume group , the agreement on uterine volume between ultrasound and MRI or histopathologic examination was fair .
-CONCLUSIONS	Our study shows that uterine volume as estimated by ultrasound and bimanual examination can be used for small or large uteri .
-CONCLUSIONS	For uteri with an intermediate volume , bimanual examination and ultrasound are less reliable .
-
-###24342495
-BACKGROUND	To test the hypothesis that the administration of antithrombin concentrate improves disseminated intravascular coagulation ( DIC ) , resulting in recovery from DIC and better outcomes in patients with sepsis , we conducted a prospective , randomized controlled multicenter trial at 13 critical care centers in tertiary care hospitals .
-METHODS	We enrolled 60 DIC patients with sepsis and antithrombin levels of 50 to 80 % in this study .
-METHODS	The participating patients were randomly assigned to an antithrombin arm receiving antithrombin at a dose of 30IU/kg per day for three days or a control arm treated with no intervention .
-METHODS	The primary efficacy end point was recovery from DIC on day 3 .
-METHODS	The analysis was conducted with an intention-to-treat approach .
-METHODS	DIC was diagnosed according to the Japanese Association for Acute Medicine ( JAAM ) scoring system .
-METHODS	The systemic inflammatory response syndrome ( SIRS ) score , platelet count and global markers of coagulation and fibrinolysis were measured on day 0 and day 3 .
-RESULTS	Antithrombin treatment resulted in significantly decreased DIC scores and better recovery rates from DIC compared with those observed in the control group on day 3 .
-RESULTS	The incidence of minor bleeding complications did not increase , and no major bleeding related to antithrombin treatment was observed .
-RESULTS	The platelet count significantly increased ; however , antithrombin did not influence the sequential organ failure assessment ( SOFA ) score or markers of coagulation and fibrinolysis on day 3 .
-CONCLUSIONS	Moderate doses of antithrombin improve DIC scores , thereby increasing the recovery rate from DIC without any risk of bleeding in DIC patients with sepsis .
-BACKGROUND	UMIN Clinical Trials Registry ( UMIN-CTR ) UMIN000000882 .
-
-###24803644
-OBJECTIVE	To investigate the effect of virtual reality ( VR ) rehabilitation on upper extremity motor performance of patients with early stroke .
-METHODS	Pilot randomized controlled trial .
-METHODS	Rehabilitation wards .
-METHODS	Twenty three adults with stroke ( mean age ( SD ) = 58.35 ( 13.45 ) years and mean time since stroke ( SD ) = 16.30 ( 7.44 ) days ) .
-METHODS	Participants were randomly assigned to VR group ( n = 11 ) or control group ( n = 12 ) .
-METHODS	VR group received nine 30 minutes upper extremity VR therapy in standing ( five weekdays in two weeks ) plus conventional therapy , which included physical and occupational therapy .
-METHODS	Control group received only conventional therapy , which was comparable to total training time received by VR group ( mean training hours ( SD ) : VR = 17.07 ( 2.86 ) ; control = 15.50 ( 2.79 ) ) .
-METHODS	The main outcome measure was the Fugl-Meyer Assessment ( FMA ) .
-METHODS	Secondary outcomes included Action Research Arm Test , Motor Activity Log and Functional Independence Measure .
-METHODS	Results were taken at baseline , post intervention and 1-month post intervention .
-METHODS	Participants ' feedback and adverse effects were recorded .
-RESULTS	All participants improved in FMA scores ( mean change ( SD ) = 11.65 ( 8.56 ) , P < .001 ) .
-RESULTS	These effects were sustained at one month after intervention ( mean ( SD ) change from baseline = 18.67 ( 13.26 ) , P < .001 ) .
-RESULTS	All other outcome measures showed similar patterns .
-RESULTS	There were no significant differences in improvement between both groups .
-RESULTS	Majority of the participants found VR training useful and enjoyable , with no serious adverse effects reported .
-CONCLUSIONS	Although additional VR training was not superior to conventional therapy alone , this study demonstrates the feasibility of VR training in early stroke .
-
-###25201887
-BACKGROUND	n-3 fatty acids inhibit neuronal excitability and reduce seizures in animal models .
-BACKGROUND	High-dose fish oil has been explored in two randomised trials in drug resistant epilepsy with negative results .
-BACKGROUND	We performed a phase II randomised controlled crossover trial of low-dose and high-dose fish oil in participants with drug resistant epilepsy to explore whether low-dose or high-dose fish oil reduces seizures or improves cardiovascular health .
-METHODS	Randomised placebo-controlled trial of low-dose and high-dose fish oil versus placebo ( corn oil , linoleic acid ) in 24 participants with drug resistant epilepsy .
-METHODS	A three-period crossover design was utilised lasting 42weeks , with three 10-week treatment periods and two 6-week washout periods .
-METHODS	All participants were randomised in double-blind fashion to receive placebo , high dose or low dose in different sequences .
-METHODS	The primary outcome was per cent change in total seizure frequency .
-RESULTS	Low-dose fish oil ( 3 capsules/day , 1080mg eicosapentaenoic acid + docosahexaenoic acid ) was associated with a 33.6 % reduction in seizure frequency compared with placebo .
-RESULTS	Low-dose fish oil was also associated with a mild but significant reduction in blood pressure .
-RESULTS	High-dose fish oil was no different than placebo in reducing seizures or improving cardiac risk factors .
-CONCLUSIONS	In this phase II randomised crossover trial , low-dose fish oil was effective in reducing seizures compared with placebo .
-CONCLUSIONS	The magnitude of improvement is similar to that of recent antiepileptic drug trials in drug resistant epilepsy ( DRE ) .
-CONCLUSIONS	The results indicate that low-dose fish oil may reduce seizures and improve the health of people with epilepsy .
-CONCLUSIONS	These findings justify a large multicentre randomised trial of low-dose fish oil ( n-3 fatty acids < 1080mg/day ) in drug resistant epilepsy .
-BACKGROUND	NCT00871377 .
-
-###25140469
-OBJECTIVE	To assess the patency of the pedicled right internal thoracic artery with an anteroaortic course and compare it to the patency of the left internal thoracic artery , in anastomosis to the left anterior descending artery in coronary artery bypass grafting by using coronary CT angiography at 6 months postoperatively .
-METHODS	Between December 2008 and December 2011 , 100 patients were selected to undergo a prospective coronary artery bypass grafting procedure without cardiopulmonary bypass .
-METHODS	The patients were randomly divided by a computer-generated list into Group-1 ( G-1 ) and Group-2 ( G-2 ) , comprising 50 patients each , the technique used was known at the beginning of the surgery .
-METHODS	In G-1 , coronary artery bypass grafting was performed using the left internal thoracic artery for the left anterior descending and the free right internal thoracic artery for the circumflex , and in G-2 , coronary artery bypass grafting was performed using the right internal thoracic artery pedicled to the left anterior descending and the left internal thoracic artery pedicled to the circumflex territory .
-RESULTS	The groups were similar with regard to the preoperative clinical data .
-RESULTS	A male predominance of 75.6 % and 88 % was observed in G-1 and G-2 , respectively .
-RESULTS	Five patients migrated from G-1 to G-2 because of atheromatous disease in the ascending aorta .
-RESULTS	The average number of distal anastomoses was 3.48 ( SD = 0.72 ) in G-1 and 3.20 ( SD = 0.76 ) in G-2 .
-RESULTS	Coronary CT angiography in 96 re-evaluated patients showed that all ITAs , right or left , used in situ for the left anterior descending were patent .
-RESULTS	There were no deaths in either group .
-CONCLUSIONS	Coronary artery bypass grafting surgery involving anastomosis of the anteroaortic right internal thoracic artery to the left anterior descending artery has an outcome similar to that obtained using the left internal thoracic artery for the same coronary site .
-
-###25301045
-BACKGROUND	Dual-energy CT technology enables acquisition of virtual unenhanced ( VUE ) images from contrast-enhanced scans .
-OBJECTIVE	To assess the feasibility of coronary artery calcium ( CAC ) scoring on VUE images derived from fast kVp-switching dual-energy coronary CT angiography .
-METHODS	Twenty-seven patients underwent true noncontrast CAC-scoring CT followed by routine single-energy ( 120-kVp ) and fast kVp-switching dual-energy coronary CT angiography , in a random acquisition order on the same day .
-METHODS	We calculated the CAC scores on true noncontrast and VUE images .
-METHODS	The image noises and the signal-to-noise and contrast-to-noise ratios of the aorta and coronary arteries were measured on both the single-energy coronary CT angiography images and dual-energy coronary CT angiography images ( 70 keV virtual monochromatic spectral images ) .
-METHODS	The Pearson correlation coefficient test and paired t test were used for statistical analysis .
-RESULTS	Excellent correlation was observed between the CAC scores on the true noncontrast and those on the VUE images ( r = 0.88 ; P < .001 ) .
-RESULTS	Compared with single-energy coronary CT angiography , dual-energy coronary CT angiography showed significantly reduced image noise and increased signal-to-noise and contrast-to-noise ratios in all regions ( all P < .001 ) .
-RESULTS	The effective dose of dual-energy coronary CT angiography ( 4.3 0.3 mSv ) was significantly lower than that of true noncontrast CAC-scoring CT plus single-energy coronary CT angiography ( 5.4 0.7 mSv ; P < .0001 ) .
-CONCLUSIONS	Excellent correlation was observed between the CAC scores on the VUE images and true noncontrast images .
-CONCLUSIONS	Thus , fast kVp-switching dual-energy coronary CT angiography could allow prediction of the true CAC scores , potentially reducing the total radiation exposure and image acquisition time by obviating the need for true noncontrast CAC-scoring CT. .
-
-###25201459
-OBJECTIVE	To evaluate the efficacy of tamsulosin therapy in reducing ureteral double-J stent morbidity by evaluating USSQ , IPSS , QOL and VAS ( primary objective ) and to evaluate the morbidity and or complication ( s ) associated with indwelling double-J ureteral stent ( s ) and to evaluate the safety of tamsulosin therapy for `` morbidity associated with double-J stents '' by evaluating its tolerability , side effects and adverse events if any ( secondary objective ) as per protocol .
-METHODS	After institutional review board approval , 60 consecutive patients with a double-J ureteral stent inserted after percutaneous nephrolithotomy or ureteroscopic stone treatment were randomly assigned to receive tamsulosin 0.4 mg , or a placebo for 4 weeks .
-METHODS	The validated USSQ , VAS and IPSS were completed before stent insertion , at 3 days and 4 weeks after stent insertion and at 2 weeks after stent removal .
-METHODS	Data were statistically analyzed for efficacy and tolerability of one drug over the other using Wilcoxon signed-rank test , Mann-Whitney test and Student 's t test .
-RESULTS	Patients receiving tamsulosin compared with the placebo showed significant decrease in urinary index score , pain index score , work performance score , VAS score at loin area , VAS score at flank , VAS score at suprapubic area , average VAS score , need for antibiotics , number of hospital visits ( P < 0.05 ) at the end of fourth weeks .
-RESULTS	Decrease in values were also observed in IPSS score , general health score , quality of sex score and IPSS-quality of life ( QOL ) score in patients taking tamsulosin but , however , the decrease was not significant .
-RESULTS	No patients discontinued medication because of side effects .
-CONCLUSIONS	We conclude that ureteral stenting using double-J stents with concomitant tamsulosin therapy was generally well tolerated , safe , effective and significantly beneficial in reducing stent morbidity in the majority of our patients .
-CONCLUSIONS	We advocate the routine use of concomitant tamsulosin therapy in eligible patients undergoing ureteral stenting in order to minimize stent morbidity .
-
-###24439932
-BACKGROUND	Parents of children with special needs are vigilant as their child may have difficulty independently escaping a burning home .
-BACKGROUND	The purpose of this study was to evaluate if providing home fire safety information via a digital video disc ( DVD ) increases families ' knowledge , behavior and ability regarding home fire safety .
-METHODS	A school based classroom intervention ( using a home fire safety DVD ) was provided to parents ( n = 40 ) of children with and without special needs to improve home fire safety knowledge , behavior and ability .
-METHODS	In addition , parents seen at the Kentucky Commission for Children with Special Health Care Needs clinics ( n = 47 ) received the same intervention in cohorts of 1-2 children .
-METHODS	For both groups , knowledge , and behavior were measured before and after intervention .
-METHODS	Repeated measures ANOVA were used to test for differences between groups and over time .
-METHODS	Significance was set at p < 0.05 .
-RESULTS	No difference in scores between pre - and post-test scores existed between groups ( with special needs vs. without special needs , or classroom vs. individualized instruction ) .
-RESULTS	However , some differences were noted for some individual survey questions during post-hoc comparisons .
-RESULTS	Having a smoke alarm in the home ( 90 % vs. 95 % , p = 0.029 ) and having a smoke alarm outside of where everyone sleeps ( 75 % vs. 95 % , p = 0.005 ) increased over time and was retained .
-RESULTS	Having a fire escape plan increased at post intervention ( 58 % vs. 79 % , p = 0.033 ) , but returned to pre levels at follow-up ( 58 % ) .
-RESULTS	Perceived knowledge ( 7.7 vs. 9.3 , p < 0.001 ) and ability ( 8.7 vs. 9.1 , p = 0.069 ) increased over time .
-CONCLUSIONS	Parents of children with special needs had a significant increase in knowledge and behavior over those parents of children without special needs .
-CONCLUSIONS	They also perceived having a high fire safety ability .
-CONCLUSIONS	Many of the post-test questions/behaviors ( e.g. , capable of exiting home during a fire , etc. ) were reported at 100 % .
-CONCLUSIONS	The intervention was well received , but may not necessarily be needed .
-CONCLUSIONS	Focus for home fire safety may need to look at younger children and smaller families .
-CONCLUSIONS	Parents of special needs children may have had frequent interaction with health care professionals .
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-###24996223
-BACKGROUND	To compare pain response outcomes for patients with spinal bone metastases treated with resistance training of the spinal musculature versus passive physical therapy during radiotherapy ( RT ) .
-METHODS	In this randomized trial , 60 consecutive patients were treated from September 2011 until March 2013 within one of the two groups : resistance training ( Arm A ) or passive physical therapy ( Arm B ) with thirty patients in each group during RT. .
-METHODS	The course of pain according to visual analog scale ( VAS ) , concurrent medication , and oral morphine equivalent dose ( OMED ) were assessed at baseline , three months , and six months after RT. .
-METHODS	Pain response was determined using International Bone Consensus response definitions .
-RESULTS	The course of VAS in the intervention group ( Arm A ) was significantly lower both during and after RT ( AUC , p < .001 ) .
-RESULTS	The use of analgetic medication showed the same result , with significantly fewer analgetics being necessary both during and after RT in arm A ( p < .001 ) .
-RESULTS	In the course of time , the OMED decreased in arm A , but increased in arm B.
-RESULTS	After 6 month , 72.2 % of patients in arm A , and 22.2 % in arm B were responders ( p = .014 ) .
-CONCLUSIONS	Our trial demonstrated that guided isometric resistance training of the paravertebral muscles can improve pain relief over a 6-months period in patients with stable spinal metastases .
-CONCLUSIONS	Importantly , the intervention was able to reduce OMED as well as concomitant pain medication .
-CONCLUSIONS	The trial is registered in Clinical trial identifier NCT 01409720 ( http://www.clinicaltrials.gov/ ) since 2nd of August 2011 .
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-###25511354
-OBJECTIVE	Prostate cancer is a major public health issue .
-OBJECTIVE	Its incidence is rising , especially in Nigeria .
-OBJECTIVE	Prompt diagnosis is necessary by histology .
-OBJECTIVE	Transperineal and transrectal approaches to prostate biopsy are well-documented .
-OBJECTIVE	Both methods are fraught with complications though , most times minor .
-OBJECTIVE	Studies carried out to compare both methods were carried out mainly on Caucasians , generating conflicting results .
-OBJECTIVE	This study aims to compare the complication rates and tissue yield of these two methods in Nigerian men .
-METHODS	Seventy-five patients completed the study .
-METHODS	Forty-five patients had transperineal prostate biopsy ( TPbx ) , while 30 patients had transrectal prostate biopsy .
-METHODS	Pain perception for all patients was determined by visual analog scale ; whereas the complications were ascertained by a validated purpose designed questionnaire administered on the 7 th and 30 th day post operatively .
-RESULTS	The risk of rectal bleeding was higher for transrectal prostate biopsy compared to transperineal ( Odds ratio : 0.03 ; 95 % confidence interval ( CI ) : 0.001-0 .450 ; P = 0.012 ) .
-RESULTS	TPbx was more painful than transrectal ( P < 0.0001 ; df : 75 ; t : 4.98 ; 95 % CI of difference in mean : -2.98 - [ -1.28 ] ) .
-RESULTS	There was no statistical difference between transperineal and transrectal prostate biopsy in hemospermia , fever , prostatic abscess , urethral bleeding , acute retention and tissue yield .
-CONCLUSIONS	TPbx is more painful than transrectal prostate biopsy though with a significantly reduced risk of rectal bleeding .
-CONCLUSIONS	There appears to be no significant difference with respect to risk of fever , urethral bleeding , hematospermia , prostatic abscess and acute retention .
-CONCLUSIONS	Both routes provided sufficient prostate tissue for histology .
-
-###24912899
-OBJECTIVE	To document the rate and outcome of trastuzumab-associated cardiac dysfunction in patients following 1 or 2 years of adjuvant therapy .
-METHODS	The Herceptin Adjuvant ( HERA ) trial is a three-arm , randomized trial comparing 2 years or 1 year of trastuzumab with observation in 5,102 patients with human epidermal growth factor receptor 2 ( HER2 ) - positive early-stage breast cancer .
-METHODS	Cardiac function was closely monitored .
-METHODS	Eligible patients had left ventricular ejection fraction ( LVEF ) 55 % at study entry following neoadjuvant chemotherapy with or without radiotherapy .
-METHODS	This 8-year median follow-up analysis considered patients randomly assigned to 2 years or 1 year of trastuzumab or observation .
-RESULTS	The as-treated safety population for 2 years of trastuzumab ( n = 1,673 ) , 1 year of trastuzumab ( n = 1,682 ) , and observation ( n = 1,744 ) is reported .
-RESULTS	Cardiac adverse events leading to discontinuation of trastuzumab occurred in 9.4 % of patients in the 2-year arm and 5.2 % of patients in the 1-year arm .
-RESULTS	Cardiac death , severe congestive heart failure ( CHF ) , and confirmed significant LVEF decrease remained low in all three arms .
-RESULTS	The incidence of severe CHF ( 0.8 % , 0.8 % , and 0.0 % , respectively ) and confirmed significant LVEF decrease ( 7.2 % , 4.1 % , and 0.9 % , respectively ) was significantly higher in the 2-year and 1-year trastuzumab arms compared with the observation arm .
-RESULTS	Severe CHF was the same for 2-year and 1-year trastuzumab .
-RESULTS	Of patients with confirmed LVEF decrease receiving 2-year trastuzumab , 87.5 % reached acute recovery .
-RESULTS	Of patients with confirmed LVEF decrease receiving 1-year trastuzumab , 81.2 % reached acute recovery .
-CONCLUSIONS	Long-term assessment at 8-year median follow-up confirms the low incidence of cardiac events for trastuzumab given sequentially after chemotherapy and radiotherapy , and cardiac events were reversible in the vast majority of patients .
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-###24981311
-BACKGROUND	Combination of fluoropyrimidines and a platinum derivative are currently standards for systemic chemotherapy in advanced adenocarcinoma of the stomach and gastroesophageal junction ( GEJ ) .
-BACKGROUND	Nevertheless , individual likelihood for response to these therapeutic regimes remains uncertain .
-BACKGROUND	Even more , no predictive markers are available to determine which patients may benefit more from oxaliplatin versus cisplatin or vice versa .
-BACKGROUND	The new invasion and stem cell markers VEGFR-3 and CXCR4 have been linked prognostically with more aggressive esophagogastric cancer types .
-BACKGROUND	Thus , we aimed to assess correlations of VEGFR-3 and CXCR4 expression levels with clinical outcome in a randomized phase III study of patients with oxaliplatin/leucovorin/5-FU ( FLO ) versus cisplatin/leucovorin/5-FU ( FLP ) .
-METHODS	The patients data examined in this study ( n = 72 ) were from the collective of the FLO vs. FLP phase III AIO trial .
-METHODS	Tumour tissues were stained via immunohistochemistry for VEGFR-3 and CXCR4 expression and results were evaluated by two independent , blinded investigators.Outcome parameter : Survival analysis was calculated for patients receiving FLO vs. FLP in relation to VEGFR-3 and CXCR4 expression .
-RESULTS	54 % and 36 % of the examined tumour tissues showed strong positive expression of VEGFR-3 and CXCR4 respectively .
-RESULTS	No superiority of each regime was detected in terms of overall survival ( OS ) in the whole population .
-RESULTS	Patients with strong expression of CXCR4 on their tumour tissues profited more in terms of OS under the treatment of FLP ( mOS : 28 vs 15 months , p = 0.05 respectively ) .
-RESULTS	Patients with negative VEGFR-3 and CXCR4 expression had a trend to live longer when FLO regime was applied ( mOS : 22 vs. 9 months , p = 0.099 and 20 vs. 10 months , p = 0.073 respectively ) .
-RESULTS	In an exploratory analysis of patients older than 60 years at diagnosis , we observed a significant benefit in overall survival for VEGFR-3 and CXCR4-positive patients when treated with FLP ( p = 0.002 , p = 0.021 respectively ) .
-CONCLUSIONS	CXCR4 positive patients profited in terms of OS from FLP , whereas FLO proved to be more effective in CXCR4 and VEGFR-3 negative patients .
-CONCLUSIONS	Our results suggest , despite the limited size of the study , a predictive value of these biomarkers concerning chemotherapy with FLP or FLO in advanced esophagogastric cancer .
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-###25408387
-OBJECTIVE	The aim of this study was to investigate the significance of the combined use of BMI and AEC in reducing the radiation dose of CT volume scans of the lumbar spine .
-METHODS	A prospective study was performed to continuously collect data from 50 patients ( age range from 19 to 60 years , male versus female 20/30 ) whose BMIs were less than 25 kg/m <formula> ^ { 2 } </formula> ( group A ) and 50 patients ( age range from 21 to 82 years , male versus female 24/26 ) whose BMIs were equal to or more than 25 kg/m <formula> ^ { 2 } </formula> ( group B ) .
-METHODS	The 50 patients in each group were randomly divided into 5 subgroups with each subgroup having lower radiation dose from subgroup 1 to 5 .
-METHODS	All the patients were performed lumbar spiral CT scans ( GE LightSpeed VCT 64-slice scanner ) and the scan parameters were different in different subgroups .
-METHODS	Volume CT dose index ( CTDIvol ) was recorded .
-METHODS	The qualities of the images were graded .
-METHODS	The one-way ANOVA and Kruskal-Wallis test were done .
-RESULTS	Both in group A and B , there were significant differences in CTDIvol among the 5 subgroups ( P < 0.001 ) .
-RESULTS	The quality of the images in the 5 subgroups of group A did n't show statistical difference .
-RESULTS	The standard deviation ( SD ) and signal to noise ratio ( SNR ) values of the L4-5 psoas major muscles in subgroup 5 of group B was statistical different from the other 4 subgroups ( P < 0.01 ) .
-CONCLUSIONS	Use of BMI combined with AEC reduces radiation dosage , without compromising the image quality .
-CONCLUSIONS	For patients in group A and group B , parameters of subgroup 5 and subgroup 4 may respectively be applied for lower dose CT scanning .
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-###24924216
-OBJECTIVE	To evaluate the distribution and extent of myocardial fibrosis identified by either contrast-enhanced Look-Locker or late gadolinium enhancement magnetic resonance imaging ( LGE MRI ) and their relationships between ventricular tachyarrhythmia or risk factors in apical hypertrophic cardiomyopathy ( APH ) .
-METHODS	Twenty-five APH patients were examined using a 3.0 T or 1.5 T instrument .
-METHODS	We used MRI to evaluate myocardial T1 values and scar .
-METHODS	We compared the myocardial fibrosis assessed by contrast-enhanced Look-Locker or LGE MRI with ventricular tachyarrhythmia or risk factors for hypertrophic cardiomyopathy .
-RESULTS	Myocardial scar was present in 17 of the 25 patients with APH .
-RESULTS	Myocardial scar was distributed predominantly in the apical myocardium ( P < 0.01 ) , whereas myocardial T1 values did not differ between the apical , midventricular , and basal septum .
-RESULTS	The extent of myocardial scar according to 16-segment model and ejection fraction were related to ventricular tachyarrhythmia or risk factors in APH ( P < 0.05 for both ) .
-RESULTS	The myocardial T1 value was not associated with the tachyarrhythmia or risk factors .
-CONCLUSIONS	In APH , the extent of myocardial scar on LGE MRI is associated with ventricular tachyarrhythmia and risk factors .
-CONCLUSIONS	Quantification of the myocardial T1 value is not necessary for its risk stratification .
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-###25876346
-OBJECTIVE	To compare the difference in clinical efficacy on children attention deficit hyperactivity disorder ( ADHD ) between the combined therapy of scalp acupuncture and EGG biofeedback and the simple EEG biofeedback therapy so as to search the better therapeutic method for ADHD .
-METHODS	One hundred patients were randomized into an observation group and a control group , 50 cases in each one .
-METHODS	In the control group , the simple EEG biofeedback therapy was adopted .
-METHODS	In the observation group , on the basis of biofeedback therapy , scalp acupuncture was added and applied to Dingzhongxian ( MS 5 ) , Dingpangyixian ( MS 8 ) , Baihui ( GV 20 ) , Sishencong ( EX-HN 1 ) , etc. .
-METHODS	The ten treatments made one session .
-METHODS	After four sessions of treatment , FIQ value in Wechsler intelligence scale , CIH score in Conners children behavior questionnaire , the ratio of 0 wave and p wave in EEG , FRCQ and FAQ in the integrated visual and auditory continuous performance test ( IVA-CPT ) and clinical comprehensive efficacy were observed before and after treatment in the two groups separately .
-RESULTS	Three cases were dropped out in the observation group and 2 cases were out in the control group .
-RESULTS	In the two groups , FIQ , FRCQ and FAQ were all increased after treatment ( P < 0.01 , P < 0.05 ) ; the increases in the observation group were much more significant than those in the control group after treatment ( all P < 0.05 ) .
-RESULTS	In the two groups , CIH score and the ratio of 0 wave and p wave were all reduced after treatment ( P < 0.01 , P < 0.05 ) ; the reduction in the observation group were much more apparent as compared with those in the control group ( both P < 0.05 ) .
-RESULTS	The total effective rate was 91.5 % ( 43/47 ) in the observation group and better than 83.3 % ( 40/48 , P < 0.01 ) in the control group .
-CONCLUSIONS	The combined therapy of scalp acupuncture and EEG biofeedback achieves the superior efficacy on children ADHD as compared with the simple biofeedback therapy .
-CONCLUSIONS	This combined therapy rapidly relieves the essential symptoms of ADHD and improves EEG waveform in children patients .
-CONCLUSIONS	Importantly , this therapy obtains and consolidates the significant efficacy .
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-###25267748
-OBJECTIVE	Although p16 protein expression , a surrogate marker of oncogenic human papillomavirus ( HPV ) infection , is recognized as a prognostic marker in oropharyngeal squamous cell carcinoma ( OPSCC ) , its prevalence and significance have not been well established in cancer of the oral cavity , hypopharynx , or larynx , collectively referred as non-OPSCC , where HPV infection is less common than in the oropharynx .
-METHODS	p16 expression and high-risk HPV status in non-OPSCCs from RTOG 0129 , 0234 , and 0522 studies were determined by immunohistochemistry ( IHC ) and in situ hybridization ( ISH ) .
-METHODS	Hazard ratios from Cox models were expressed as positive or negative , stratified by trial , and adjusted for clinical characteristics .
-RESULTS	p16 expression was positive in 14.1 % ( 12 of 85 ) , 24.2 % ( 23 of 95 ) , and 19.0 % ( 27 of 142 ) and HPV ISH was positive in 6.5 % ( six of 93 ) , 14.6 % ( 15 of 103 ) , and 6.9 % ( seven of 101 ) of non-OPSCCs from RTOG 0129 , 0234 , and 0522 studies , respectively .
-RESULTS	Hazard ratios for p16 expression were 0.63 ( 95 % CI , 0.42 to 0.95 ; P = .03 ) and 0.56 ( 95 % CI , 0.35 to 0.89 ; P = .01 ) for progression-free ( PFS ) and overall survival ( OS ) , respectively .
-RESULTS	Comparing OPSCC and non-OPSCC , patients with p16-positive OPSCC have better PFS and OS than patients with p16-positive non-OPSCC , but patients with p16-negative OPSCC and non-OPSCC have similar outcomes .
-CONCLUSIONS	Similar to results in patients with OPSCC , patients with p16-negative non-OPSCC have worse outcomes than patients with p16-positive non-OPSCC , and HPV may also have a role in outcome in a subset of non-OPSCC .
-CONCLUSIONS	However , further development of a p16 IHC scoring system in non-OPSCC and improvement of HPV detection methods are warranted before broad application in the clinical setting .
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-###25007225
-BACKGROUND	Fatigue and emotional reactivity are common among women suffering from breast cancer and might detrimentally affect these women 's quality of life .
-BACKGROUND	This study evaluates if the stress management delivered either in a group or individual setting would improve fatigue and emotional reactivity among women with a newly diagnosed breast cancer .
-METHODS	Participants ( n = 304 ) who reported elevated levels of distress at three-month post-inclusion were randomised between stress management in a group ( GSM ) ( n = 77 ) or individual ( ISM ) ( n = 78 ) setting .
-METHODS	Participation was declined by 149 women .
-METHODS	Participants completed the Multidimensional Fatigue Inventory ( MFI-20 ) and the Everyday Life Stress Scale ( ELSS ) at the time of inclusion , 3 - and 12-month post-inclusion .
-METHODS	Analyses were made according to intention to treat and per-protocol principles .
-METHODS	Mann-Whitney tests were used to examine differences between the two intervention groups .
-RESULTS	No significant differences were detected between the GSM and ISM groups on fatigue or emotional reactivity .
-RESULTS	In addition , there were no changes over time for these outcomes .
-CONCLUSIONS	There were no differences between the two intervention arms with reference to fatigue or emotional reactivity ; however , a clinically interesting finding was the low number of women who were interested in participating in a psychosocial intervention .
-CONCLUSIONS	This finding may have clinical implications when psychosocial support is offered to women with a newly diagnosed breast cancer and also in the planning of future studies .
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-###25636519
-OBJECTIVE	To improve the quality of chest compression ( CC ) , we developed the assistant-push method , whereby the second rescuer pushes the back of the chest compressor during CC .
-OBJECTIVE	We investigated the effectiveness and feasibility of assistant push in achieving and maintaining the CC quality .
-METHODS	This was a randomized crossover trial in which 41 subjects randomly performed both of standard CC ( single-rescuer group ) and CC with instructor-driven assistant push ( assistant-push group ) in different order .
-METHODS	Each session of CC was performed for 2 minutes using a manikin .
-METHODS	Subjects were also assigned to both roles of chest compressor and assistant and together performed CC with subject-driven assistant push .
-METHODS	Depth of CC , compression to recoil ratio , duty cycle , and rate of incomplete recoil were quantified .
-RESULTS	The mean depth of CC ( 57.0 [ 56.0-59 .0 ] vs 55.0 [ 49.5-57 .5 ] , P < .001 ) was significantly deeper , and the compression force ( 33.8 [ 29.3-36 .4 ] vs 23.3 [ 20.4-25 .3 ] , P < .001 ) was stronger in the assistant-push group .
-RESULTS	The ratio of compression to recoil , duty cycle , and rate of incomplete chest recoil were comparable between the 2 groups .
-RESULTS	The CC depth in the single-rescuer group decreased significantly every 30 seconds , whereas in the assistant-push group , it was comparable at 60 - and 90-second time points ( P = .004 ) .
-RESULTS	The subject assistant-push group performed CCs at a depth comparable with that of the instructor assistant-push group .
-CONCLUSIONS	The assistant-push method improved the depth of CC and attenuated its decline , eventually helping maintain adequate CC depth over time .
-CONCLUSIONS	Subjects were able to feasibly learn assistant push and performed effectively .
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-###25713888
-BACKGROUND	Midodrine is an - agonist prodrug of desglymidodrine used for the management of hypotension .
-BACKGROUND	Midodrine has demonstrated usefulness in hepatorenal syndrome .
-OBJECTIVE	The objective of the present work was to study the role of midodrine in patients with non-azotemic cirrhosis with tense ascites .
-METHODS	This prospective randomized double blind placebo-controlled study was conducted on 67 non azotemic inpatients with liver cirrhosis and tense ascites ( 52 men and 15 women ; age range , 45-72 ) .
-METHODS	One patient declined to participate in the study , 33 patients were randomly assigned to take midodrine hydrochloride , and 33 patients were randomly assigned to take placebo .
-METHODS	Out of 67 enrolled patients , 60 patients ( 30 : in midodrine group ; 30 : in placebo group ) completed the study and 6 patients lost to follow up .
-METHODS	Patients were assessed for patients characteristics , history of tapping their ascetic fluid , laboratory values , and Doppler parameters before and after the study .
-METHODS	Average 24-h urine volume was assessed before and after the start of the study .
-RESULTS	significant reduction in body weight and abdominal girth was observed after 2 weeks of midodrine therapy .
-CONCLUSIONS	Midodrine appeared to be effective in lowering body weights and abdominal girths of non azotemic cirrhotic patients with tense ascites .
-
-###24833235
-BACKGROUND	Antiarrhythmic drugs ( AADs ) and anticoagulation are mainstays of atrial fibrillation ( AF ) treatment .
-OBJECTIVE	To study the use and outcomes of AAD therapy in anticoagulated patients with AF .
-METHODS	Patients in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation trial ( N = 14,264 ) were stratified by AAD use at baseline : amiodarone , other AAD , or no AAD .
-METHODS	Multivariable adjustment was performed to compare stroke , bleeding , and death across AAD groups as well as across treatment assignment ( rivaroxaban or warfarin ) .
-RESULTS	Of 14,264 patients randomized , 1681 ( 11.8 % ) were treated with an AAD ( 1144 [ 8 % ] with amiodarone and 537 [ 3.8 % ] with other AADs ) .
-RESULTS	Amiodarone-treated patients were less often female ( 38 % vs 48 % ) , had more persistent AF ( 64 % vs 40 % ) , and more concomitant heart failure ( 71 % vs 41 % ) than were patients receiving other AADs .
-RESULTS	Patients receiving no AAD more closely resembled amiodarone-treated patients .
-RESULTS	Time in therapeutic range was significantly lower in warfarin-treated patients receiving amiodarone than in those receiving no AAD ( 50 % vs 58 % ; P < .0001 ) .
-RESULTS	Compared with no AAD , neither amiodarone ( adjusted hazard ratio [ HR ] 0.98 ; 95 % confidence interval [ CI ] 0.74-1 .31 ; P = .9 ) nor other AADs ( adjusted HR 0.66 ; 95 % CI 0.37-1 .17 ; P = .15 ) were associated with increased mortality .
-RESULTS	Similar results were observed for embolic and bleeding outcomes .
-RESULTS	Treatment effects of rivaroxaban vs warfarin in patients receiving no AAD were consistent with results from the overall trial ( primary end point : adjusted HR 0.82 ; 95 % CI 0.68-0 .98 ; Pinteraction = .06 ; safety end point : adjusted HR 1.12 ; 95 % CI 0.90-1 .24 ; Pinteraction = .33 ) .
-CONCLUSIONS	Treatment with AADs was not associated with increased morbidity or mortality in anticoagulated patients with AF .
-CONCLUSIONS	The effect of amiodarone on outcomes in patients receiving rivaroxaban requires further investigation .
-
-###25819856
-BACKGROUND	Mental stress-induced myocardial ischemia ( MSIMI ) is common in patients with ischemic heart disease ( IHD ) and associated with a poorer cardiovascular prognosis .
-BACKGROUND	Platelet hyperactivity is an important factor in acute coronary syndrome .
-BACKGROUND	This study examined associations between MSIMI and resting and mental stress-induced platelet activity .
-METHODS	Eligible patients with clinically stable IHD underwent a battery of 3 mental stress tests during the recruitment phase of REMIT study .
-METHODS	MSIMI was assessed by echocardiography and electrocardiography .
-METHODS	Ex vivo platelet aggregation in response to ADP , epinephrine , collagen , serotonin , and combinations of serotonin plus ADP , epinephrine , and collagen were evaluated as was platelet serotonin transporter expression .
-RESULTS	Of the 270 participants who completed mental stress testing , and had both resting and post-stress platelet aggregation evaluation , 43.33 % ( n = 117 ) met criteria for MSIMI and 18.15 % ( n = 49 ) had normal left ventricular response to stress ( NLVR ) .
-RESULTS	The MSIMI group , relative to the NLVR groups , demonstrated heightened mental stress-induced aggregation responses , as measured by area under the curve , to collagen 10M ( 6.95 [ 5.54 ] vs. -14.23 [ 8.75 ] .
-RESULTS	; P = 0.045 ) , epinephrine 10M ( 12.84 [ 4.84 ] vs. -6.40 [ 7.61 ] .
-RESULTS	; P = 0.037 ) and to serotonin 10 M plus ADP 1 M ( 6.64 [ 5.29 ] vs. -27.34 [ 8.34 ] ; P < .001 ) .
-RESULTS	The resting platelet aggregation and serotonin transporter expression , however , were not different between the two groups .
-CONCLUSIONS	These findings suggest that the dynamic change of platelet aggregation caused by mental stress may underlie MSIMI .
-CONCLUSIONS	While the importance of these findings requires additional investigation , they raise concern given the recognized relationship between mental stress-induced platelet hyperactivity and cardiovascular events in patients with IHD .
-
-###25340383
-BACKGROUND	Surgical and medical treatments for emphysema may affect both quality and quantity of life .
-BACKGROUND	The purpose of this article is to report outcomes from the National Emphysema Treatment Trial ( NETT ) using an index that combines quality and quantity of life .
-METHODS	This was a prospective randomized clinical trial .
-METHODS	Following pulmonary rehabilitation , 1,218 patients with severe emphysema were randomly assigned to maximal medical therapy or to lung volume reduction surgery ( LVRS ) .
-METHODS	A generic quality-of-life measure , known as the Quality of Well-being Scale ( QWB ) , was administered at baseline and again at 6 , 12 , 24 , 36 , 48 , 60 , and 72 months following treatment assignment .
-RESULTS	At baseline , QWB scores were comparable for the Medical and LVRS groups .
-RESULTS	For both groups , scores significantly improved following the rehabilitation program .
-RESULTS	The QWB scores before death for patients in the LVRS group improved up to the year 2 visit , whereas scores for the Medical group dropped significantly following the baseline visit .
-RESULTS	Imputing zeros ( 0 ) for death , QWB scores decreased significantly for both groups .
-RESULTS	With or without scoring death as 0 , the LVRS group achieved better outcomes , and the significant differences were maintained until the sixth year .
-RESULTS	Over 6 years of follow-up , LVRS produced an average of 0.30 quality-adjusted life years ( QALYs ) , or the equivalent of about 3.6 months of well life .
-CONCLUSIONS	Compared with maximal medical therapy alone , patients undergoing maximal medical therapy plus LVRS experienced improved health-related quality of life and gained more QALYs .
-BACKGROUND	ClinicalTrials.gov ; No. : NCT00000606 ; URL : www.clinicaltrials.gov .
-
-###24228534
-OBJECTIVE	To observe the effect of combination of Immune 1 and HAART on the CD4 + T cell count and its immune reconstitution rate .
-METHODS	Two hundred and twenty eight HIV/AIDS patients were randomly divided into treatment group and control group , patients from treatment group received Immune 1 combined HAART therapy , patients from control group was given placebo combined HAART and evaluate the change of CD4 + T cell count and its immune reconstitution rate .
-RESULTS	In patients with CD4 + T cells baseline level ( 200-350 cell x microL ( -1 ) ) , Immune reconstitution rate of treatment group is significantly higher than the control group .
-CONCLUSIONS	Immune 1 combined HAART can effectively promote the immune reconstitution of patients with high CD4 + T cells baseline level ( 200-350 cell x microL ( -1 ) ) and show little side effect and is safe to treat HIV/AIDS disease .
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-###24726095
-BACKGROUND	Concurrent treatment of HIV and tuberculosis is complicated by drug interactions .
-BACKGROUND	We explored the safety and efficacy of raltegravir as an alternative to efavirenz for patients co-infected with HIV and tuberculosis .
-METHODS	We did a multicentre , phase 2 , non-comparative , open-label , randomised trial at eight sites in Brazil and France .
-METHODS	Using a computer-generated randomisation sequence , we randomly allocated antiretroviral-naive adult patients with HIV-1 and tuberculosis ( aged 18 years with a plasma HIV RNA concentration of > 1000 copies per mL ) to receive raltegravir 400 mg twice a day , raltegravir 800 mg twice daily , or efavirenz 600 mg once daily plus tenofovir and lamivudine ( 1:1:1 ; stratified by country ) .
-METHODS	Patients began study treatment after the start of tuberculosis treatment .
-METHODS	The primary endpoint was virological suppression at 24 weeks ( HIV RNA < 50 copies per mL ) in all patients who received at least one dose of study drug ( modified intention-to-treat analysis ) .
-METHODS	We recorded death , study drug discontinuation , and loss to follow-up as failures to achieve the primary endpoint .
-METHODS	We assessed safety in all patients who received study drugs .
-METHODS	This study is registered in ClinicalTrials.gov , number NCT00822315 .
-RESULTS	Between July 3 , 2009 , and June 6 , 2011 , we enrolled and randomly assigned treatment to 155 individuals ; 153 ( 51 in each group ) received at least one dose of the study drug and were included in the primary analysis .
-RESULTS	133 patients ( 87 % ) completed follow-up at week 48 .
-RESULTS	At week 24 , virological suppression was achieved in 39 patients ( 76 % , 95 % CI 65-88 ) in the raltegravir 400 mg group , 40 patients ( 78 % , 67-90 ) in the raltegravir 800 mg group , and 32 patients ( 63 % , 49-76 ) in the efavirenz group .
-RESULTS	The adverse-event profile was much the same across the three groups .
-RESULTS	Three ( 6 % ) patients allocated to efavirenz and three ( 6 % ) patients allocated to raltegravir 800 mg twice daily discontinued the study drugs due to adverse events .
-RESULTS	Seven patients died during the study ( one in the raltegravir 400 mg group , four in the raltegravir 800 mg group , and two in the efavirenz group ) : none of the deaths was deemed related to study treatment .
-CONCLUSIONS	Raltegravir 400 mg twice daily might be an alternative to efavirenz for the treatment of patients co-infected with HIV and tuberculosis .
-BACKGROUND	French National Agency for Research on AIDS and Viral Hepatitis ( ANRS ) , Brazilian National STD/AIDS Program-Ministry of Health .
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-###25242045
-BACKGROUND	Panobinostat is a potent oral pan-deacetylase inhibitor that in preclinical studies has synergistic anti-myeloma activity when combined with bortezomib and dexamethasone .
-BACKGROUND	We aimed to compare panobinostat , bortezomib , and dexamethasone with placebo , bortezomib , and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma .
-METHODS	PANORAMA1 is a multicentre , randomised , placebo-controlled , double-blind phase 3 trial of patients with relapsed or relapsed and refractory multiple myeloma who have received between one and three previous treatment regimens .
-METHODS	Patients were randomly assigned ( 1:1 ) via an interactive web-based and voice response system , stratified by number of previous treatment lines and by previous use of bortezomib , to receive 21 day cycles of placebo or panobinostat ( 20 mg ; on days 1 , 3 , 5 , 8 , 10 , 12 , orally ) , both in combination with bortezomib ( 13 mg/m ( 2 ) on days 1 , 4 , 8 , 11 , intravenously ) and dexamethasone ( 20 mg on days 1 , 2 , 4 , 5 , 8 , 9 , 11 , 12 , orally ) .
-METHODS	Patients , physicians , and the investigators who did the data analysis were masked to treatment allocation ; crossover was not permitted .
-METHODS	The primary endpoint was progression-free survival ( in accordance with modified European Group for Blood and Marrow Transplantation criteria and based on investigators ' assessment ) and was analysed by intention to treat .
-METHODS	The study is ongoing , but no longer recruiting , and is registered at ClinicalTrials.gov , number NCT01023308 .
-RESULTS	768 patients were enrolled between Jan 21 , 2010 , and Feb 29 , 2012 , with 387 randomly assigned to panobinostat , bortezomib , and dexamethasone and 381 to placebo , bortezomib , and dexamethasone .
-RESULTS	Median follow-up was 647 months ( IQR 181-1347 ) in the panobinostat group and 559 months ( 214-1130 ) in the placebo group .
-RESULTS	Median progression-free survival was significantly longer in the panobinostat group than in the placebo group ( 1199 months [ 95 % CI 1033-1294 ] vs 808 months [ 756-923 ] ; hazard ratio [ HR ] 063 , 95 % CI 052-076 ; p < 00001 ) .
-RESULTS	Overall survival data are not yet mature , although at the time of this analysis , median overall survival was 3364 months ( 95 % CI 3134-not estimable ) for the panobinostat group and 3039 months ( 2687-not estimable ) for the placebo group ( HR 087 , 95 % CI 069-110 ; p = 026 ) .
-RESULTS	The proportion of patients achieving an overall response did not differ between treatment groups ( 235 [ 607 % , 95 % CI 557-656 ] for panobinostat vs 208 [ 546 % , 494-597 ] for placebo ; p = 009 ) ; however , the proportion of patients with a complete or near complete response was significantly higher in the panobinostat group than in the placebo group ( 107 [ 276 % , 95 % CI 232-324 ] vs 60 [ 157 % , 122-198 ] ; p = 000006 ) .
-RESULTS	Minimal responses were noted in 23 ( 6 % ) patients in the panobinostat group and in 42 ( 11 % ) in the placebo group .
-RESULTS	Median duration of response ( partial response or better ) was 1314 months ( 95 % CI 1176-1492 ) in the panobinostat group and 1087 months ( 923-1176 ) in the placebo group , and median time to response ( partial response or better ) was 151 months ( 141-164 ) in the panobinostat group and 200 months ( 161-279 ) in the placebo group .
-RESULTS	Serious adverse events were reported in 228 ( 60 % ) of 381 patients in the panobinostat group and 157 ( 42 % ) of 377 patients in the placebo group .
-RESULTS	Common grade 3-4 laboratory abnormalities and adverse events ( irrespective of association with study drug ) included thrombocytopenia ( 256 [ 67 % ] in the panobinostat group vs 118 [ 31 % ] in the placebo group ) , lymphopenia ( 202 [ 53 % ] vs 150 [ 40 % ] ) , diarrhoea ( 97 [ 26 % ] vs 30 [ 8 % ] ) , asthenia or fatigue ( 91 [ 24 % ] vs 45 [ 12 % ] ) , and peripheral neuropathy ( 67 [ 18 % ] vs 55 [ 15 % ] ) .
-CONCLUSIONS	Our results suggest that panobinostat could be a useful addition to the treatment armamentarium for patients with relapsed or relapsed and refractory multiple myeloma .
-CONCLUSIONS	Longer follow up will be necessary to determine whether there is any effect on overall survival .
-BACKGROUND	Novartis Pharmaceuticals .
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-###25494594
-BACKGROUND	Corn peptides ( CPs ) are a novel food prepared from corn gluten meal , which is a main by-product of the corn starch industry .
-BACKGROUND	Recently , significant beneficial effects of CPs on early alcoholic liver injury in rats and on acute alcoholic injury in mice were observed .
-BACKGROUND	To our knowledge , the present study is the first report showing that CPs supplementation has beneficial effects on lipid profile , oxidative stress and alcoholic liver injury in men with chronic alcohol consumption .
-METHODS	A 9-week , randomized , double-blind , placebo-controlled study was conducted between September 2011 and August 2012 to assess the hepatoprotective effect of CPs .
-METHODS	A total of 161 men were randomized to receive CPs ( n = 53 ) , whey protein ( n = 54 ) , or corn starch placebo ( n = 54 ) at the same dose of 2 g twice daily .
-METHODS	146 participants completed the study .
-METHODS	Serum lipid profile , serum markers of liver injury , oxidative stress and inflammation , and fatty liver based on the results of abdominal ultrasonography were assessed at the beginning and end of the intervention .
-RESULTS	CPs supplementation ( 4 g/d ) for 9 weeks significantly lowered serum levels or activities of total cholesterol , triglyceride , alanine aminotransferase , aspartate aminotransferase , malondialdehyde and tumor necrosis factor - , and significantly increased serum activities of superoxide dismutase and glutathione peroxidase , but the same dose of whey protein and corn starch ( placebo ) did not demonstrate these effects .
-CONCLUSIONS	Our results indicate that CPs may have protective effects on alcohol-induced liver damage via modulation of lipid metabolism and oxidative stress .
-CONCLUSIONS	CPs may potentially be used as a functional food for the management of alcoholic liver disease in subjects with chronic alcohol consumption .
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-###24772415
-OBJECTIVE	The aim of this study was to investigate the effect of i.v. infusion of magnesium sulphate during spinal anesthesia on duration of spinal block and postoperative pain .
-METHODS	Forty ASA physical status I and status II , aged between 18 and 65 , female patients undergoing abdominal hysterectomy under spinal anesthesia were enrolled in this study .
-METHODS	Patients in the magnesium group ( Group M , n = 20 ) received magnesium sulphate 65 mg kg ( -1 ) infusion in 250 mL 5 % dextrose at 3.5 mL/min rate , and control group ( Group C , n = 20 ) received at the same volume of saline during operation in a double-blind randomized manner .
-METHODS	Duration of sensory and motor block , systolic , diastolic , and mean arterial blood pressures , heart rates , pain scores ( VAS values ) , and side effects were recorded for each patient .
-METHODS	Blood and CSF samples were taken for analysis of magnesium concentrations .
-RESULTS	Regression of sensorial block was longer in Group M when compared with that in Group C ( 175 39 versus 136 32 min ) ( P < 0.01 ) .
-RESULTS	The VAS scores were lower in Group M than those in Group C at the 2 time points postoperatively ( P < 0.01 ) .
-CONCLUSIONS	65 mg kg ( -1 ) of magnesium sulphate i.v. infusion under spinal anesthesia prolongs spinal sensorial block duration and decreases pain VAS scores without complication in patients undergoing abdominal hysterectomy .
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-###24803481
-OBJECTIVE	To explore effects of a pre-screening life style survey on the subsequent attendance proportion in colorectal cancer screening .
-METHODS	Finnish colorectal cancer screening programme in 2011 .
-METHODS	Double randomized and controlled follow-up design .
-METHODS	The study population comprised of 31,951 individuals born in 1951 .
-METHODS	In 2010 to a random sample of every sixth ( n = 5,312 ) person we sent a 7-paged life style questionnaire , and to another random sample of every sixth person ( n = 5,336 ) a 10-paged life style and quality of life questionnaire .
-METHODS	One year later , in 2011 , 31,484 individuals of the original cohort were independently randomized ( 1:1 ) for colorectal cancer screening ( n = 15,748 ) or control group ( n = 15,736 ) .
-METHODS	Of those who were invited for screening , 5185 had received a questionnaire during the previous year .
-RESULTS	5870 individuals ( 55.1 % ) responded to the questionnaire in 2010 .
-RESULTS	The overall attendance at screening in 2011 was 59.0 % in those born in 1951 ( i.e. the 60-year-olds ) .
-RESULTS	In those who had been sent the survey the attendance in screening was 56.6 % ( 57.3 % for the short and 56.0 % for the long questionnaire ) and in those who had not received the questionnaire it was 60.2 % ( P < 0.001 ) .
-CONCLUSIONS	We believe that the observed reduction in attendance in those who had been sent a questionnaire earlier is generally true .
-CONCLUSIONS	Thus , if any survey is enclosed in the screening invitation , this finding should be taken into account when planning the programme .
-CONCLUSIONS	Any extra effort requested may reduce the attendance proportion for screening , reducing the population level impact of screening .
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-###24594059
-OBJECTIVE	Under the directly observed treatment , short course ( DOTS ) program , antituberculosis ( anti-TB ) medications were possibly taken at random time , regardless of whether it was prior to or after meals .
-OBJECTIVE	This study was to evaluate the impact of food intake on pharmacokinetic profiles of first-line TB drugs in Taiwanese TB patients , as well as the relationship between drug levels and pharmacogenetics .
-METHODS	This open-label , randomized , cross-over study included newly diagnosed Taiwanese TB patients treated between January 2010 and February 2011 at Taipei Medical University-Wan Fang Hospital .
-METHODS	Rifater [ a fixed-dose combination formulation of isoniazid ( INH ) , rifampicin ( RIF ) , and pyrazinamide ( PZA ) ] and ethambutol ( EMB ) were given according to national TB guidelines .
-METHODS	Blood samples were collected prior to and 1 hour , 2 hours , 4 hours , 6 hours , and 10 hours after dosing under fasting or postprandial conditions .
-METHODS	Pharmacokinetic parameters of the maximum serum concentration ( Cmax ) , time to Cmax , and area under the serum concentration-time curve from the beginning to the 10 ( th ) hour ( AUC0-10 ) were calculated .
-RESULTS	Sixteen TB patients were included and received anti-TB treatment under the DOTS program after discharge .
-RESULTS	The overall effects showed that food intake reduced the mean Cmax ( INH : 40.6 % , RIF : 40.2 % , EMB 34.4 % , PZA : 24.4 % ) and AUC0-10 ( INH : 21.3 % , RIF : 26.4 % , EMB : 12.2 % , PZA : 12.0 % ) .
-RESULTS	Meanwhile , food increased the time to Cmax ( INH : 78.1 % , RIF : 151.3 % , EMB : 41.4 % , PZA : 148.9 % ) .
-CONCLUSIONS	Significantly lower serum drug concentrations were observed under postprandial conditions than fasting conditions for INH , RIF , and PZA .
-CONCLUSIONS	The impact of taking random anti-TB drugs under the DOTS program instead of taking drugs regularly prior to meals requires further study .
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-###25117820
-BACKGROUND	Bevacizumab has broad anti-tumour activity , but substantial risk of hypertension .
-BACKGROUND	No reliable markers are available for predicting bevacizumab-induced hypertension .
-METHODS	A genome-wide association study ( GWAS ) was performed in the phase III bevacizumab-based adjuvant breast cancer trial , ECOG-5103 , to evaluate for an association between genotypes and hypertension .
-METHODS	GWAS was conducted in those who had experienced systolic blood pressure ( SBP ) > 160mmHg during therapy using binary analysis and a cumulative dose model for the total exposure of bevacizumab .
-METHODS	Common toxicity criteria ( CTC ) grade 3-5 hypertension was also assessed .
-METHODS	Candidate SNP validation was performed in the randomised phase III trial , ECOG-2100 .
-RESULTS	When using the phenotype of SBP > 160mmHg , the most significant association in SV2C ( rs6453204 ) approached and met genome-wide significance in the binary model ( P = 6.0 10 ( -8 ) ; OR = 3.3 ) and in the cumulative dose model ( P = 4.7 10 ( -8 ) ; HR = 2.2 ) , respectively .
-RESULTS	Similar associations with rs6453204 were seen for CTC grade 3-5 hypertension but did not meet genome-wide significance .
-RESULTS	Validation study from ECOG-2100 demonstrated a statistically significant association between this SNP and grade 3/4 hypertension using the binary model ( P-value = 0.037 ; OR = 2.4 ) .
-CONCLUSIONS	A genetic variant in SV2C predicted clinically relevant bevacizumab-induced hypertension in two independent , randomised phase III trials .
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-###25881753
-OBJECTIVE	This thorough QT/QTc ( TQT ) study assessed the effects of a supratherapeutic dose of pomaglumetad methionil , a potential treatment for schizophrenia , compared to placebo on the QT interval in subjects with schizophrenia .
-METHODS	This double-blind , 3-period crossover study enrolled 86 subjects aged 22 - 63 years , who met Diagnostic and Statistical Manual , Fourth Edition , Test Revision ( DSM-IV-TR ) criteria for schizophrenia ; 78 subjects completed the study .
-METHODS	Subjects were randomly assigned to sequences of 3 treatment periods of single oral doses of pomaglumetad methionil 400 mg , moxifloxacin 400 mg , and placebo .
-METHODS	Quadruplicate electrocardiograms ( ECGs ) were extracted from 2 hours predose to 12 hours postdose and were overread by a blinded central reader .
-METHODS	Time-matched pharmacokinetic ( PK ) parameters were assessed .
-RESULTS	At all-time points , the upper bound of the 90 % 2-sided confidence interval ( CI ) for the least squares ( LS ) mean difference in changes from baseline in Fridericia 's corrected QT interval ( QTcF ) between pomaglumetad methionil and placebo was < 10 milliseconds ( msec ) .
-RESULTS	Sufficient assay sensitivity was not achieved , likely due to food effect ; although the maximum observed drug concentration ( Cmax ) with moxifloxacin ( 1,410 ng/mL ) was lower than expected , the slope of the regression line of moxifloxacin plasma concentrations versus placebo-subtracted QTcF was similar to that reported in the literature .
-CONCLUSIONS	A single supratherapeutic dose of 400 mg pomaglumetad methionil did not prolong QTcF to a clinically significant degree and , importantly , did not result in any absolute QTcF > 450 msec or increase in QTcF from predose > 30 msec .
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-###25286026
-OBJECTIVE	The purpose of this study was to evaluate the efficacy of once-daily guanfacine extended release ( GXR ) monotherapy administered either in the morning or evening , using a modified Conners ' Parent Rating Scale-Revised : Short Form ( CPRS-R : S ) assessed three times/day in children with attention-deficit/hyperactivity disorder ( ADHD ) .
-METHODS	This multicenter , double-blind , placebo-controlled study randomized children 6-12 years of age with ADHD into three groups : GXR a.m. ( GXR in the morning and placebo in the evening ) , GXR p.m. ( placebo in the morning and GXR in the evening ) , or twice-daily placebo .
-METHODS	The CPRS-R : S , administered in the morning , afternoon , and evening prior to each study visit , was a secondary measure of efficacy .
-RESULTS	A total of 333 subjects were included in the analysis population ( GXR a.m. , n = 107 ; GXR p.m. , n = 114 ; placebo , n = 112 ) .
-RESULTS	At visit 10 , last observation carried forward ( LOCF ) , subjects receiving GXR demonstrated significantly greater improvement from baseline in the daily mean CPRS-R : S total score , as well as in each of the morning , afternoon , and evening CPRS-R : S assessments , compared with placebo , regardless of the time of GXR administration ( p < 0.001 vs. placebo for GXR a.m. and GXR p.m. ) .
-RESULTS	In addition , subjects receiving GXR showed significantly greater improvements from baseline in each subscale score ( oppositional , cognitive problems/inattention , hyperactivity , and ADHD index ) compared with those receiving placebo , regardless of time of administration ( p < 0.003 vs. placebo across all subscales for GXR a.m. and GXR p.m. ) .
-CONCLUSIONS	These results provide further support for the demonstrated efficacy of once-daily GXR in reducing ADHD symptoms , and demonstrate that response is consistent throughout the day regardless of the time of administration , with improvement seen in ratings of oppositional as well as of ADHD symptoms .
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-###24742739
-BACKGROUND	Disease progression in patients with HER2-positive breast cancer receiving trastuzumab might be associated with activation of the PI3K/Akt/mTOR intracellular signalling pathway .
-BACKGROUND	We aimed to assess whether the addition of the mTOR inhibitor everolimus to trastuzumab might restore sensitivity to trastuzumab .
-METHODS	In this randomised , double-blind , placebo-controlled , phase 3 trial , we recruited women with HER2-positive , trastuzumab-resistant , advanced breast carcinoma who had previously received taxane therapy .
-METHODS	Eligible patients were randomly assigned ( 1:1 ) using a central patient screening and randomisation system to daily everolimus ( 5 mg/day ) plus weekly trastuzumab ( 2 mg/kg ) and vinorelbine ( 25 mg/m ( 2 ) ) or to placebo plus trastuzumab plus vinorelbine , in 3-week cycles , stratified by previous lapatinib use .
-METHODS	The primary endpoint was progression-free survival ( PFS ) by local assessment in the intention-to-treat population .
-METHODS	We report the final analysis for PFS ; overall survival follow-up is still in progress .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT01007942 .
-RESULTS	Between Oct 26 , 2009 , and May 23 , 2012 , 569 patients were randomly assigned to everolimus ( n = 284 ) or placebo ( n = 285 ) .
-RESULTS	Median follow-up at the time of analysis was 20.2 months ( IQR 15.0-27 .1 ) .
-RESULTS	Median PFS was 7.00 months ( 95 % CI 6.74-8 .18 ) with everolimus and 5.78 months ( 5.49-6 .90 ) with placebo ( hazard ratio 0.78 [ 95 % CI 0.65-0 .95 ] ; p = 0.0067 ) .
-RESULTS	The most common grade 3-4 adverse events were neutropenia ( 204 [ 73 % ] of 280 patients in the everolimus group vs 175 [ 62 % ] of 282 patients in the placebo group ) , leucopenia ( 106 [ 38 % ] vs 82 [ 29 % ] ) , anaemia ( 53 [ 19 % ] vs 17 [ 6 % ] ) , febrile neutropenia ( 44 [ 16 % ] vs ten [ 4 % ] ) , stomatitis ( 37 [ 13 % ] vs four [ 1 % ] ) , and fatigue ( 34 [ 12 % ] vs 11 [ 4 % ] ) .
-RESULTS	Serious adverse events were reported in 117 ( 42 % ) patients in the everolimus group and 55 ( 20 % ) in the placebo group ; two on-treatment deaths due to adverse events occurred in each group .
-CONCLUSIONS	The addition of everolimus to trastuzumab plus vinorelbine significantly prolongs PFS in patients with trastuzumab-resistant and taxane-pretreated , HER2-positive , advanced breast cancer .
-CONCLUSIONS	The clinical benefit should be considered in the context of the adverse event profile in this population .
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-###24809838
-BACKGROUND	Opioid consumption after posterior spinal fusion is known to be high and often exceeds those reported in other major surgical procedures .
-BACKGROUND	A number of clinical trials provide evidence that the perioperative use of subanesthetic doses of ketamine reduces pain and opioid requirements in some surgical procedures , but the effect of prolonged perioperative low-dose ketamine infusion in patients undergoing posterior spinal fusion for pediatric scoliosis surgery is unknown .
-OBJECTIVE	To test the hypothesis that a 72-h perioperative low-dose ketamine infusion would decrease opioid use in pediatric patients undergoing posterior spinal fusion .
-METHODS	In a double-blind prospective controlled trial , patients undergoing posterior spinal fusion for scoliosis were randomized to receive perioperative low-dose ketamine or placebo control .
-METHODS	Patients received general anesthesia , intraoperative remifentanil , and morphine patient-controlled analgesia postoperatively .
-METHODS	Daily opioid consumption , self-reported pain scores , and sedation scores were measured .
-RESULTS	Fifty-four patients were enrolled and 50 completed the study .
-RESULTS	Contrary to our hypothesis , ketamine - and control-treated patients had similar postoperative opioid use , pain scores , and sedation scores measurements .
-RESULTS	In contrast , ketamine-treated patients required less intraoperative remifentanil compared with control ( mean 2.9 mg vs. 4mg , P = 0.0415 ) .
-RESULTS	Number of vertebrae instrumented , time between end-of-surgery and 24h assessment , or remifentanil doses did not impact on postoperative opioid use .
-RESULTS	Over 96-h postoperatively , morphine-equivalent consumption was lower ( -0.40 , P = 0.006 ) and sedation score was higher ( 0.47 , P = 0.0211 ) in male patients , compared with female patients .
-CONCLUSIONS	These findings do not support the use of perioperative low-dose ketamine to decrease opioid use in children with scoliosis undergoing posterior spinal fusion .
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-###24593664
-BACKGROUND	Emollient therapy is used frequently to prevent nosocomial infection in the management of preterm infants , despite a lack of adequate evidence of its efficacy .
-OBJECTIVE	To assess the efficacy of prophylactic whole-body application of pure preservative-free topical petroleum jelly on the incidence of nosocomial sepsis in very low-birthweight ( VLBW ) infants .
-METHODS	A prospective , randomised controlled trial of the application of topical petroleum jelly was conducted .
-METHODS	Infants weighing < 1250 g at birth and with a gestational age of 32 weeks were included .
-METHODS	The intervention group received twice-daily topical therapy of 2 g/kg pure , preservative-free topical petroleum jelly until the completion of 34 weeks of gestation .
-METHODS	The control group received no topical petroleum jelly treatment .
-METHODS	The primary outcome was the incidence of late-onset sepsis during hospitalisation .
-METHODS	Other data collected included the pattern of temperature control , weight changes , fluid requirements , serum bilirubin level , electrolyte imbalance and skin condition .
-RESULTS	Thirty-five infants in the intervention group and 39 in the control group were recruited .
-RESULTS	Birthweight , gestational age , gender and perinatal variables were comparable in the two groups .
-RESULTS	There was a trend towards an increased incidence of culture-proven nosocomial sepsis in the intervention group - 19 episodes ( 54 % ) in the intervention group vs 16 ( 41 % ) in the control group , and an increased rate of NEC - 20 % in the intervention group vs 8 % in the control group .
-RESULTS	The intervention group had better skin condition throughout their stay and the incubator ambient temperature was lower in the intervention group in the 1st week of life .
-RESULTS	The fluid balance of the infants in the intervention group was better , as reflected by their mean ( SD ) shorter time to regain birthweight [ 12 ( 5 ) vs 14 ( 6 ) days ] , and there were fewer episodes of hypernatraemia in the 1st week of life , although none of these reached statistical significance .
-RESULTS	However , there was a significantly lower mean ( SD ) level of maximum hyperbilirubinaemia [ 157 ( 40 ) vs 182 ( 46 ) mmol/L , P = 002 ) in the intervention group .
-CONCLUSIONS	Although prophylactic topical application of pure , preservative-free petroleum jelly brought substantial improvement of skin condition and temperature control , it was associated with a trend towards an increased rate of nosocomial sepsis .
-
-###25434320
-OBJECTIVE	To study the efficacy and safety of drotaverine hydrochloride ( HCl ) 80 mg tablet given thrice a day in the symptomatic relief of patients with irritable bowel syndrome ( IBS ) .
-METHODS	The study was a multicentric , randomized , double-blind , placebo-controlled parallel group study performed at three centers .
-METHODS	The patients who fulfilled Rome II Criteria of IBS were included in the study .
-METHODS	A total of 180 patients with IBS were randomized to drotaverine and placebo treatment groups .
-METHODS	Abdominal pain and stool frequency were measured every week in both the groups for all the 4 weeks of treatment duration .
-METHODS	Subject Global Assessment of Relief ( SGA ) of IBS symptoms was assessed at the end of the study .
-METHODS	Appropriate statistical analysis was done using SPSS software .
-METHODS	Mann-Whitney U-test ( two-tailed ) , Wilcoxon signed ranks test , and McNemar tests .
-RESULTS	Pain frequency decreased significantly ( P < 0.01 ) in 22 ( 25.9 % ) , 51 ( 60 % ) , and 66 ( 77.7 % ) patients in the drotaverine group , at the end of 2nd , 3rd , and 4th weeks , respectively , as compared with 8 ( 9.4 % ) , 18 ( 21.2 % ) , and 26 ( 30.6 % ) in the placebo group .
-RESULTS	Pain severity scores also decreased significantly in the drotaverine group 66 ( 77.7 % ) as compared with placebo 26 ( 30.6 % ) after 4 weeks .
-RESULTS	Drotaverine HCl was shown to provide significant improvement ( P < 0.01 ) in global relief in abdominal pain as perceived by the patient ( 85.9 % vs 39.5 % ) and the clinician ( 82.4 % vs 36.5 % ) in the drotaverine group as compared with placebo .
-RESULTS	There is significant ( P < 0.01 ) improvement in stool frequency in drotaverine HCl treatment group as compared with placebo .
-RESULTS	The drug is well tolerated without any major side effects .
-CONCLUSIONS	A 4-week treatment with drotaverine significantly improves abdominal symptoms in patients with IBS .
-
-###24385331
-BACKGROUND	Patients with end-stage renal failure ( ESRF ) need integrated health care to maintain a desirable quality of life .
-BACKGROUND	Studies suggest that post-discharge nurseled telephone support has a positive effect for patients suffering from chronic diseases .
-BACKGROUND	But the post-discharge care is under-developed in mainland China and the effects of post-discharge care on patients with peritoneal dialysis have not been conclusive .
-OBJECTIVE	The purpose of this study is to test the effectiveness of postdischarge nurse-led telephone support on patients with peritoneal dialysis in mainland China .
-METHODS	A randomized controlled trial was conducted in the medical department of a regional hospital in Guangzhou .
-METHODS	135 patients were recruited , 69 in the study group and 66 in the control group .
-METHODS	The control group received routine hospital discharge care .
-METHODS	The study group received post-discharge nurse-led telephone support .
-METHODS	The quality of life ( Kidney Disease Quality of Life Short Form , KDQOL-SF ) , blood chemistry , complication control , readmission and clinic visit rates were observed at three time intervals : baseline before discharge ( T1 ) , 6 ( T2 ) and 12 ( T3 ) weeks after discharge .
-RESULTS	Statistically significant effects were found for symptom/problem , work status , staff encouragement , patient satisfaction and energy/fatigue in KDQOL-SF and 84-day ( 12-week ) clinic visit rates between the two groups .
-RESULTS	The study group had more significant improvement than the control group for sleep , staff encouragement at both T2 and T3 , and pain at T2 and patient satisfaction at T3 .
-RESULTS	No significant differences were observed between the two groups for the baseline measures , other dimensions in KDQOL-SF , blood chemistry , complication control , readmission rates at all time intervals and clinic visit rates at the first two time intervals .
-CONCLUSIONS	Post-discharge nurse-led telephone support for patients undergoing peritoneal dialysis is effective to enhance patients ' well-being in the transition from hospital to home in mainland China .
-
-###25637380
-BACKGROUND	Neoadjuvant treatment provides a unique opportunity to evaluate individual tumor sensitivity .
-BACKGROUND	This study evaluated whether a response-guided strategy could improve clinical outcome compared with a standard treatment .
-METHODS	Overall , 264 previously untreated stage II-III operable breast cancer patients were randomized to receive either standard treatment ( arm A , n = 131 ) , consisting of fluorouracil , epirubicin , and cyclophosphamide ( FEC100 : 500 , 100 , and 500 mg/m ( 2 ) , respectively , for 3 cycles ) followed by docetaxel ( 100 mg/m ( 2 ) for 3 cycles ) , or adapted treatment ( arm B , n = 133 ) , beginning with 2 cycles of FEC100 and switching to docetaxel if tumor size decreased by < 30 % after 2 cycles or < 50 % after 4 cycles of FEC100 ( ultrasound assessments according to World Health Organization criteria ) .
-METHODS	Otherwise , FEC100 was given for six cycles before surgery .
-METHODS	Intent-to-treat analysis was performed .
-RESULTS	Similar results were observed for clinical response ( objective response was 54 % vs 56 % , p = .18 ) , breast conservation surgery ( BCS ; 67 % vs 68 % , p = .97 ) , and pathological complete response rate ( Chevallier classification : 14 % vs 11 % , p = .68 ; Statloff classification : 16 % vs 13 % , p = .82 ) between arms A and B. Similar toxicities were observed , even with unbalanced numbers of FEC100 and docetaxel courses .
-CONCLUSIONS	Adapted and standard treatments had similar results in terms of tumor response , BCS rate , and tolerability .
-CONCLUSIONS	Further survival outcome data are expected .
-
-###26021224
-OBJECTIVE	To evaluate the influence of at least three abutment changes against the placement of a definitive abutment , which was no longer removed , on hard and soft tissue changes , and to compare the clinical outcomes of immediate non-occlusal loading versus conventional loading .
-METHODS	Eighty patients requiring one single crown or one fixed partial prosthesis supported by a maximum of three implants were randomised , after implants were placed with more than 35 Ncm , according to a parallel group design to receive definitive abutments which were loaded immediately ( definitive abutment or immediate loading group ) or transmucosal abutments which experienced delayed loading after 3 months and were removed at least three times : 1 ) during the making of the impression ( 3 months after implant placement ) ; 2 ) when checking the zirconium core of titanium abutments at single crowns or the fitting of the metal structure at prostheses supported by multiple implants ; 3 ) at delivery of the definitive prostheses ( repeated disconnection or conventional loading group ) .
-METHODS	Patients were treated in four centres and each patient contributed to the study with only one prosthesis followed for 4 months after initial loading .
-METHODS	Outcome measures were : prosthesis/implant failures , any complication , peri-implant marginal bone level changes , and patient satisfaction .
-RESULTS	Forty patients were randomly allocated to each group according to a parallel group design .
-RESULTS	No patient dropped-out and no implants failed .
-RESULTS	However four provisional prostheses and one definitive prosthesis had to be remade because of misfitting ( five single crowns ) in the repeated disconnection group ; and one provisional prosthesis had to be remade because of frequent debondings in the immediate loading group ( difference = 10 % ; 95 % CI : -1 % , 21 % ; P = 0.109 ) .
-RESULTS	Five complications ( all debondings of the provisional prostheses ) were reported in two patients of the immediate loading group , in comparison to three biological complications in three patients of the repeated disconnection group ( difference = 2 % ; 95 % CI : -8 % , 13 % ; P = 1 ) .
-RESULTS	All patients were very satisfied or satisfied with the function and aesthetics of the prostheses , and would undergo the same procedure again .
-RESULTS	Mean peri-implant marginal bone loss 4 months after loading was -0.08 ( 0.16 ) mm for the definitive abutment group and -0.09 ( 0.20 ) mm for the repeated abutment changes group ( difference = 0.01 ; 95 % CI : -0.07 , 0.09 ; P = 0.97 ) .
-RESULTS	There were no statistically significant differences for any of the outcome measures between the two procedures up to 4 months after initial loading .
-CONCLUSIONS	Preliminary short-term data ( 4-month post-loading ) showed that repeated abutment changes do not alter bone levels significantly .
-CONCLUSIONS	Immediate non-occlusal loading of dental implants are a viable alternative to conventional loading .
-CONCLUSIONS	Therefore clinicians can use the procedure they find more convenient for their specific patient .
-
-###24843957
-OBJECTIVE	To observe the efficacy difference of electroacupuncture and auricular acupuncture in the treatment of methamphetamine withdrawal syndrome .
-METHODS	Ninety male patients of methamphetamine addiction were randomized into an electroacupuncture group , an auricular acupuncture group and a control group , 30 cases in each one .
-METHODS	In the electroacupuncture group , Neiguan ( PC 6 ) , Shenmen ( HT 7 ) , Zusanli ( ST 36 ) , Sanyinjiao ( SP 6 ) , Jiaji ( EX-B 2 ) at T5 and L2 were selected bilaterally .
-METHODS	In the auricular acupuncture group , jiaogan ( AH ( 6a ) ) , shenmen ( TF4 ) , fei ( CO14 ) and gan ( CO12 ) were selected unilaterally .
-METHODS	The treatment was given 3 times a week , totally 12 treatments were required .
-METHODS	In the control group , no any intervention was applied .
-METHODS	Separately , before treatment and after 1 , 2 , 3 and 4 weeks treatment , the scores of methamphetamine withdrawal syndrome , Hamilton anxiety scale and Hamilton depression scale were observed in each group .
-RESULTS	The total score of methamphetamine withdrawal syndrome , anxiety score and depression score were obviously reduced in 2 , 3 and 4 weeks of treatment as compared with those before treatment in the electroacupuncture group and the auricular acupuncture group ( all P < 0.05 ) , and showed a trend of gradual decline as the extension of treatment .
-RESULTS	In 1,2,3,4 weeks of treatment , the total score of withdrawal syndrome , anxiety score and depression score in the electroacupuncture group and auricular acupuncture group were lower significantly than those in the control group ( all P < 0.05 ) , in which , the total score of withdrawal syndrome in the electroacupuncture group was lower significantly than that in the auricular acupuncture group in the 4th week of treatment ( 3.69 + / - 2.446 vs 5.73 + / - 3.169 , P < 0.05 ) ; the anxiety scores were lower significantly than those in the auricular acupuncture group in 3 and 4 weeks of treatment ( 8.19 + / - 4.57 vs 9.65 + / - 4.24 , 5.27 + / - 2.89 vs 7.38 + / - 3.10 , both P < 0.05 ) ; the depression scores were lower significantly than those in the auricular acupuncture group in 2 , 3 and 4 weeks of treatment ( 15.35 + / - 5.64 vs 19.81 + / - 5.37 , 10.96 + / - 4.52 vs 15.00 + / - 4.53 , 7.96 + / - 2.69 vs 12.35 + / - 3.59 , all P < 0.05 ) .
-CONCLUSIONS	Electroacupuncture at the body points and auricular acupuncture play the therapeutic role in the treatment of methamphetamine withdrawal syndrome , anxiety and depression .
-CONCLUSIONS	The longer time the treatment is with electroacupuncture at the body points , the more obvious the efficacy will be on the above symptoms .
-
-###24355665
-BACKGROUND	Influenza vaccination coverage for U.S. school-aged children is below the 80 % national goal .
-BACKGROUND	Primary care practices may not have the capacity to vaccinate all children during influenza vaccination season .
-BACKGROUND	No real-world models of school-located seasonal influenza ( SLV-I ) programs have been tested .
-OBJECTIVE	Determine the feasibility , sustainability , and impact of an SLV-I program providing influenza vaccination to elementary school children during the school day .
-METHODS	In this pragmatic randomized controlled trial of SLV-I during two vaccination seasons , schools were randomly assigned to SLV-I versus standard of care .
-METHODS	Seasonal influenza vaccine receipt , as recorded in the state immunization information system ( IIS ) , was measured .
-METHODS	Intervention and control schools were located in a single western New York county .
-METHODS	Participation ( intervention or control ) included the sole urban school district and suburban districts ( five in Year 1 , four in Year 2 ) .
-METHODS	After gathering parental consent and insurance information , live attenuated and inactivated seasonal influenza vaccines were offered in elementary schools during the school day .
-METHODS	Data on receipt of 1 seasonal influenza vaccination in Year 1 ( 2009-2010 ) and Year 2 ( 2010-2011 ) were collected on all student grades K through 5 at intervention and control schools from the IIS in the Spring of 2010 and 2011 , respectively .
-METHODS	Additionally , coverage achieved through SLV-I was compared to coverage of children vaccinated elsewhere .
-METHODS	Preliminary data analysis for Year 1 occurred in Spring 2010 ; final quantitative analysis for both years was completed in late Fall 2012 .
-RESULTS	Results are shown for 2009-2010 and 2010-2011 , respectively : Children enrolled in suburban SLV-I versus control schools had vaccination coverage of 47 % vs 36 % , and 52 % vs 36 % ( p < 0.0001 both years ) .
-RESULTS	In urban areas , coverage was 36 % vs 26 % , and 31 % vs 25 % ( p < 0.001 both years ) .
-RESULTS	On multilevel logistic analysis with three nested levels ( student , school , school district ) during both vaccination seasons , children were more likely to be vaccinated in SLV-I versus control schools ; ORs were 1.6 ( 95 % CI = 1.4 , 1.9 ; p < 0.001 ) and 1.5 ( 95 % CI = 1.3 , 1.8 ; p < 0.001 ) .
-CONCLUSIONS	Delivering influenza vaccine during school is a promising approach to improving pediatric influenza vaccination coverage .
-BACKGROUND	ClinicalTrials.govNCT01224301 .
-
-###24895382
-OBJECTIVE	Our aim was to evaluate the feasibility of a hydrotherapy treatment in patients with Parkinson 's disease and the effectiveness of this treatment on balance parameters in comparison to a traditional land-based physical therapy .
-METHODS	A randomized single-blind controlled trial .
-METHODS	Outpatients .
-METHODS	Thirty-four patients with Parkinson 's disease in Hoehn-Yahr stage 2.5-3 .
-METHODS	Group 1 hydrotherapy treatment , group 2 land-based rehabilitation treatment .
-METHODS	The two groups underwent the same rehabilitation period ( 60 minutes of treatment , five days a week for two months ) .
-METHODS	The primary outcome measures were the centre of the pressure sway area recorded with open and closed eyes , using a stabilometric platform .
-METHODS	Secondary outcome measures were Unified Parkinson 's Disease Rating Scale II and III , Timed Up and Go Test , Berg Balance Scale , Activities-specific Balance Confidence Scale , Falls Efficacy Scale , Falls diary and Parkinson 's Disease Questionnaire-39 .
-RESULTS	Hydrotherapy treatment proved to be feasible and safe .
-RESULTS	Patients in both groups had a significant improvement in all outcome variables .
-RESULTS	There was a better improvement in patients who underwent hydrotherapy than in patients treated with land-based therapy in the centre of pressure sway area closed eyes ( mean SD change : 45.4 SD64 .9 vs. 6.9 SD45 .3 , p = 0.05 ) , Berg Balance Scale ( 51.2 SD3 .1 vs. 6.0 SD3 .1 , p = 0.005 ) , Activities-specific Balance Confidence Scale ( 16.8 SD10 .6 vs. 4.1 SD5 .4 , p = 0.0001 ) , Falls Efficacy Scale ( -5.9 SD4 .8 vs. -1.9 SD1 .4 , p = 0.003 ) , Parkinson 's Disease Quetionnaire-39 ( -18.4 SD12 .9 vs. -8.0 SD7 .0 , p = 0.006 ) and falls diary ( -2.4 SD2 .2 vs. -0.4 SD0 .5 , p = 0.001 ) .
-CONCLUSIONS	Our study suggests that hydrotherapy may constitute a possible treatment for balance dysfunction in Parkinsonian patients with moderate stage of disease .
-
-###25946647
-OBJECTIVE	To compare the demographic characteristics and intra - and postoperative outcomes in elderly adults ( 75 ) with those of younger adults undergoing early ( < 5 days after onset of complaints ) cholecystectomy .
-METHODS	Retrospective analysis from May 2010 to August 2012 .
-METHODS	Randomized , multicenter , clinical trial ( ABCAL Study , NCT01015417 ) .
-METHODS	Individuals with mild or moderate acute calculous cholecystitis ( ACC ) according to the Tokyo Guidelines ( N = 414 ; n = 78 aged 75-94 , median 82 ; n = 336 aged 18-74 , median 49 ) .
-METHODS	Demographic characteristics and pre - , intra - , and postoperative data .
-RESULTS	The elderly group was more likely to have an American Society of Anesthesiologists score of 3 or greater ( 62 % vs 23 % , P < .001 ) , higher serum creatinine ( 103 vs 74 mol/L , P < .001 ) , and more-severe ACC ( moderate ACC ( 62 % vs 50 % , P = .05 ) , gangrenous cholecystitis ( 38 % vs 15 % , P = .001 ) ) on preoperative imaging and confirmed intraoperatively .
-RESULTS	Ulcerated mucosa ( 76 % vs 61 % , P = .001 ) was significantly more frequent in the elderly group .
-RESULTS	Operative time , postoperative mortality , and postoperative infectious ( 18 % vs 14 % , P = .35 ) and noninfectious ( 9 % vs 3 % , P = .80 ) complications were similar between the two groups .
-RESULTS	Median length of stay ( 7.0 vs 5.0 days , P = .54 ) and readmission rate ( 15 % vs 4 % , P = .07 ) were not significantly higher in the elderly group .
-RESULTS	No significant difference was observed for the subgroup of participants aged 80 and older .
-CONCLUSIONS	In this randomized trial that included a selected sample of older adults , there was no difference in major outcomes between elderly adults and their younger counterparts after early cholecystectomy .
-CONCLUSIONS	The findings are limited because important geriatric outcomes such as delirium and functional decline were not examined .
-
-###24317208
-OBJECTIVE	The aim of present study was to find a better procedure to prevent synkinesis in facial nerve palsy .
-METHODS	A randomized clinical trial .
-METHODS	Clinical rehabilitation faculty and general rehabilitation centers .
-METHODS	Twenty - nine patients with facial nerve palsy were selected via electrodiagnosis tests .
-METHODS	The experimental group ( n = 16 ) was treated with biofeedback electromyography , whereas the control group ( n = 13 ) received common physiotherapy .
-METHODS	All patients received 1-year treatment .
-METHODS	Evaluation of facial grading scale before and after treatment and severity of synkinesia .
-RESULTS	At the end of treatment , there was a rise in facial grading system in both groups compared with baseline ( p < 0.05 , paired t test ) .
-RESULTS	There were significant differences in the facial grading system between 2 groups at the end of the study , but the experimental group showed better result than the other one .
-RESULTS	The number of patients with synkinesis and the severity of their synkinesis in the experimental group were lesser than those of the control group .
-CONCLUSIONS	Biofeedback therapy is more efficient than common physiotherapy .
-CONCLUSIONS	By using this approach , controlling and reducing synkinesis is more feasible .
-
-###24393516
-OBJECTIVE	The aim of study was to evaluate setting-specific quality indicators ( QIs ) for shared-housing arrangements ( SHA ) regarding effects of a guided quality development process on resident 's quality of life ( QoL ) .
-BACKGROUND	SHA are a specific German kind of small-scale living facilities for care-dependent persons with dementia .
-BACKGROUND	SHA are disconnected from residential facilities and served by community care services .
-METHODS	In a longitudinal cluster-randomised design 104 residents of 34 SHA were surveyed for 1 year ; the intervention group took part in a quality development process .
-METHODS	QIs , physical and psychological health outcomes including QoL were surveyed .
-RESULTS	During the 1 year follow-up , analyses show a positive trend regarding QI-outcomes in the intervention group , but no statistically significant differences could be proved regarding QoL .
-CONCLUSIONS	Setting-sensitive QIs are absolutely essential to measure quality of care in multi-professional settings like SHA .
-CONCLUSIONS	Further research as well as longer study intervals is essential .
-
-###24795201
-BACKGROUND	In clinical trials , treatment with a combination of the nucleotide polymerase inhibitor sofosbuvir and the antiviral drug ribavirin was associated with high response rates among patients with hepatitis C virus ( HCV ) genotype 2 infection , with lower response rates among patients with HCV genotype 3 infection .
-METHODS	We conducted a study involving patients with HCV genotype 2 or 3 infection , some of whom had undergone previous treatment with an interferon-based regimen .
-METHODS	We randomly assigned 91 patients with HCV genotype 2 infection and 328 with HCV genotype 3 infection , in a 4:1 ratio , to receive sofosbuvir-ribavirin or placebo for 12 weeks .
-METHODS	On the basis of emerging data from phase 3 trials indicating that patients with HCV genotype 3 infection had higher response rates when they were treated for 16 weeks , as compared with 12 weeks , the study was unblinded , treatment for all patients with genotype 3 infection was extended to 24 weeks , the placebo group was terminated , and the goals of the study were redefined to be descriptive and not include hypothesis testing .
-METHODS	The primary end point was a sustained virologic response at 12 weeks after the end of therapy .
-RESULTS	Of the 419 patients who were enrolled and treated , 21 % had cirrhosis and 58 % had received previous interferon-based treatment .
-RESULTS	The criterion for a sustained virologic response was met in 68 of 73 patients ( 93 % ; 95 % confidence interval [ CI ] , 85 to 98 ) with HCV genotype 2 infection who were treated for 12 weeks and in 213 of 250 patients ( 85 % ; 95 % CI , 80 to 89 ) with HCV genotype 3 infection who were treated for 24 weeks .
-RESULTS	Among patients with HCV genotype 3 infection , response rates were 91 % and 68 % among those without and those with cirrhosis , respectively .
-RESULTS	The most common adverse events were headache , fatigue , and pruritus .
-CONCLUSIONS	Therapy with sofosbuvir-ribavirin for 12 weeks in patients with HCV genotype 2 infection and for 24 weeks in patients with HCV genotype 3 infection resulted in high rates of sustained virologic response .
-CONCLUSIONS	( Funded by Gilead Sciences ; VALENCE ClinicalTrials.gov number , NCT01682720 . )
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-###25484177
-OBJECTIVE	Herbal remedies play an important role in treatment of psychiatric disorders .
-OBJECTIVE	The aim of this study was to assess the efficacy of crocin , the main active constituent of saffron , as an adjunctive treatment in major depressive disorder ( MDD ) .
-METHODS	This study was a randomized , double-blind , placebo-controlled , pilot clinical trial .
-METHODS	It was carried out during 4 weeks in two groups ( placebo and treatment ) on 40 MDD patients between 24 and 50 years old in Ibn-e-Sina psychiatric hospital , Mashhad , Iran , from March 2013 to December 2013 .
-METHODS	The crocin group ( n = 20 ) was given one selective serotonin reuptake inhibitor ( SSRI ) drug ( fluoxetine 20mg/day or sertraline 50mg/day or citalopram 20mg/day ) plus crocin tablets ( 30mg/day ; 15mg BID ) and placebo group ( n = 20 ) was administered one SSRI ( fluoxetine 20mg/day or sertraline 50mg/day or citalopram 20mg/day ) plus placebo ( two placebo tablets per day ) for 4 weeks .
-METHODS	Both groups filled beck depression inventory ( BDI ) , beck anxiety inventory ( BAI ) , general health questionnaire ( GHQ ) , the mood disorder questionnaire ( MDQ ) , side effect evaluation questionnaire , and demographic questionnaire before and after one month intervention .
-RESULTS	The crocin group showed significantly improved scores on BDI , BAI and GHQ compared to placebo group ( Pvalue < 0.0001 ) .
-RESULTS	The averages of decrease in BDI , BAI and GHQ scores in placebo group were 6.15 , 2.6 and 10.3 respectively , whereas the values in crocin group were 17.6 , 12.7 and 17.2 after 4 weeks trial .
-CONCLUSIONS	Poor patient compliance with medications and short trial period , small sample size and self-report assessments were the major limitations of this study .
-CONCLUSIONS	These results demonstrated the effect of crocin in depression and could be administered in treatment of MDD patients .
-
-###25339468
-OBJECTIVE	We aimed to determine the relationship between blood lactate , carboxy-hemoglobin ( COHb ) levels and the severity of clinical findings in patients with CO poisoning .
-METHODS	Patients over 18 years old and of both gender who were admitted to Emergency Department with the diagnosis of CO poisoning between 10.02.2008 and 17.03.20011 were enrolled in this study .
-METHODS	Detailed physical examination of each patient was performed , patients and their relatives were informed about the study and written consents were noted .
-METHODS	The levels of consciousness , physical examination findings , electrocardiographic findings , Glasgow Coma Scale ( GCS ) scores , laboratory results ( lactate , COHb , CK-MB , Troponin-I levels ) and applied treatments [ normobaric oxygen therapy ( NBOT ) , hyperbaric oxygen therapy ( HBOT ) ] were recorded to standart data entry form for each patient .
-METHODS	SPSS for Windows version 18 package program was used for statistical analysis of the data .
-RESULTS	Total 201 patients were included in this study .
-RESULTS	Thirty five patients ( 17.4 % ) received HBOT and lactate , COHb , CKMB , Troponin-I levels of this group were higher than the other patients .
-RESULTS	Lactate and COHb levels were statistically significantly higher in patients with GCS < 15 than the ones with GCS = 15 ( p < 0.01 ) .
-RESULTS	The patients whose both Troponin-I and CK-MB levels increased have higher lactate levels ( p = 0.038 ) , but COHb levels of these patients did not change ( p = 0.495 ) .
-CONCLUSIONS	According to our study , blood lactate and COHb levels were both correlated with the changes of consciousness in CO poisoning .
-CONCLUSIONS	Blood lactate levels together with COHb in defining indications for HBO treatment might be suggested .
-
-###24443820
-BACKGROUND	Internet-based cognitive behavioural therapy ( ICBT ) is a promising approach to the prevention and reduction of depressive symptoms among adolescents .
-BACKGROUND	This study aimed to evaluate the feasibility and efficacy of disseminating a self-directed internet-based mental health intervention ( MoodGYM ) in senior high schools .
-BACKGROUND	It also sought to investigate possible effects of tailored and weekly e-mail reminders on initial uptake and adherence to the intervention .
-METHODS	A baseline survey was conducted in four senior high schools in two Norwegian municipalities ( n = 1337 ) .
-METHODS	52.8 % ( 707/1337 ) of the students consented to further participation in the trial and were randomly allocated to one of three MoodGYM intervention groups ( tailored weekly e-mail reminder ( n = 175 ) , standardized weekly e-mail reminder ( n = 176 ) or no e-mail reminder ( n = 175 ) ) or a waitlist control group ( n = 180 ) .
-METHODS	We tested for effects of the intervention on depression and self-esteem using multivariate analysis of variance , effects of tailored e-mail and self-reported current need of help on initial uptake of the intervention using logistic regression and the effect of weekly e-mails on adherence using ordinal regression .
-RESULTS	There was substantial non-participation from the intervention , with only 8.5 % ( 45/527 ) participants logging on to MoodGYM , and few proceeding beyond the first part of the programme .
-RESULTS	No significant effect on depression or self-esteem was found among the sample as a whole or among participants with elevated depression scores at baseline .
-RESULTS	Having a higher average grade in senior high school predicted initial uptake of the intervention , but tailored e-mail and self-reported current need of help did not .
-RESULTS	Weekly e-mail prompts did not predict adherence .
-RESULTS	The main reasons for non-use reported were lack of time/forgetting about it and doubt about the usefulness of the program .
-CONCLUSIONS	Overall , disseminating a self-directed internet-based intervention to a school population proved difficult despite steps taken to reduce barriers in terms of tailoring feedback and dispatching weekly e-mail reminders .
-CONCLUSIONS	Providing mental health interventions within the school environment is likely to ensure better uptake among senior high school students , but there is a need to effectively communicate that such programmes can be helpful .
-BACKGROUND	The trial was registered retrospectively as ACTRN12612001106820 .
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-###24220504
-BACKGROUND	Osteoarthritis is a relatively common musculoskeletal disorder that increases in prevalence with age .
-BACKGROUND	Worldwide , knee osteoarthritis is one of the leading causes of disability , particularly in the elderly .
-BACKGROUND	In numerous trials of agents for long-term pain therapy , no well-established and replicable results have been achieved .
-BACKGROUND	Complementary and alternative medical approaches have been employed for thousands of years to relieve knee osteoarthritis pain .
-BACKGROUND	Among herbal medicines , the golden plaster is the preferred and most commonlyused method in China to reduce pain in patients with knee osteoarthritis , as it causes few adverse effects .
-BACKGROUND	The purpose of this study will be to evaluate the efficacy and safety of golden plaster on pain in patients with knee osteoarthritis .
-METHODS	This study will be a multicenter randomized , double-blind , placebo-controlled trial .
-METHODS	A total of 320 participants aged 45 to 79 years with knee osteoarthritis , whose scores on a visual analog scale ( VAS ) are more than 20 mm , will be randomly allocated into a treatment group and a control group .
-METHODS	A golden plaster will be administered externally to participants in the treatment group for 2 weeks , while the control group will receive a placebo plaster externally for 2 weeks .
-METHODS	Follow-up will be at regular intervals during a 4-week period with a VAS score for pain , quality of life , and complications .
-CONCLUSIONS	This study will be a methodologically sound randomized controlled trial to assess pain relief after the intervention of golden plaster , compared to a placebo intervention in patients with knee osteoarthritis .
-BACKGROUND	ClinicalTrials.gov identifier : ChiCTR-TRC-13003418 .
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-###24499951
-OBJECTIVE	Tenofovir disoproxil fumarate ( TDF ) pre-exposure prophylaxis decreases sexual acquisition of HIV infection .
-OBJECTIVE	We sought to evaluate the renal safety of TDF in HIV-uninfected persons .
-METHODS	The Iniciativa Profilaxis Pre-Exposicin ( iPrEx ) study randomly assigned 2499 HIV-seronegative men and transgender women who have sex with men ( MSM ) to receive oral daily TDF coformulated with emtricitabine ( FTC/TDF ) or placebo .
-METHODS	Serum creatinine and phosphorus during randomized treatment and after discontinuation were measured , and creatinine clearance ( CrCl ) was estimated by the Cockcroft-Gault equation .
-METHODS	Indicators of proximal renal tubulopathy ( fractional excretion of phosphorus and uric acid , urine protein , and glucose ) were measured in a substudy .
-RESULTS	There was a small but statistically significant decrease in CrCl from baseline in the active arm , compared to placebo , which was first observed at week 4 ( mean change : -2.4 vs. -1.1 ml/min ; P = 0.02 ) , persisted through the last on-treatment visit ( mean change : +0.3 vs. +1.8 ml/min ; P = 0.02 ) , and resolved after stopping pre-exposure prophylaxis ( mean change : -0.1 vs. 0.0 ml/min ; P = 0.83 ) .
-RESULTS	The effect was confirmed when stratifying by drug detection .
-RESULTS	The effect of FTC/TDF on CrCl did not vary by race , age , or history of hypertension .
-RESULTS	There was no difference in serum phosphate trends between the treatment arms .
-RESULTS	In the substudy , two participants receiving placebo had indicators of tubulopathy .
-CONCLUSIONS	In HIV-seronegative MSM , randomization to FTC/TDF was associated with a very mild nonprogressive decrease in CrCl that was reversible and managed with routine serum creatinine monitoring .
-
-###25375075
-BACKGROUND	Statin use is frequently associated with muscle-related symptoms .
-BACKGROUND	Coenzyme Q10 supplementation has yielded conflicting results in decreasing statin myopathy .
-BACKGROUND	Herein , we tested whether coenzyme Q10 supplementation could decrease statin-associated muscular pain in a specific group of patients with mild-to-moderate muscle symptoms .
-METHODS	Fifty patients treated with statins and reporting muscle pain were recruited .
-METHODS	The Q10 group ( n = 25 ) received coenzyme Q10 supplementation over a period of 30 days ( 50 mg twice daily ) , and the control group ( n = 25 ) received placebo .
-METHODS	The Brief Pain Inventory ( BPI ) questionnaire was used and blood testing was performed at inclusion in the study and after 30 days of supplementation .
-RESULTS	The intensity of muscle pain , measured as the Pain Severity Score ( PSS ) , in the Q10 group was reduced from 3.90.4 to 2.90.4 ( P < 0.001 ) .
-RESULTS	The Pain Interference Score ( PIS ) after Q10 supplementation was reduced from 4.00.4 to 2.60.4 ( P < 0.001 ) .
-RESULTS	In the placebo group , PSS and PIS did not change .
-RESULTS	Coenzyme Q10 supplementation decreased statin-related muscle symptoms in 75 % of patients .
-RESULTS	The relative values of PSS and PIS significantly decreased ( -33.1 % and -40.3 % , respectively ) in the Q10 group compared to placebo group ( both P < 0.05 ) .
-RESULTS	From baseline , no differences in liver and muscle enzymes or cholesterol values were found .
-CONCLUSIONS	The present results show that coenzyme Q10 supplementation ( 50 mg twice daily ) effectively reduced statin-related mild-to-moderate muscular symptoms , causing lower interference of statin-related muscular symptoms with daily activities .
-
-###25223178
-OBJECTIVE	To observe the clinical effect of Guilu Erxian Glue Cataplasm ( GEGC ) on carcinoma of the large intestine patients with myelosuppression after chemotherapy , and further to confirm its efficiency and safety .
-METHODS	Totally 60 patients with carcinoma of the large intestine were randomly assigned to two groups .
-METHODS	Meanwhile , they all accepted FOLFIRI chemotherapy .
-METHODS	Patients in the treatment group were additionally applied at Shenque ( RN8 ) , exchanging once per every other day , for 14 successive days .
-METHODS	Patients in the control group took placebos with the same dose and dosage as the treatment group .
-METHODS	The blood cell counts ( WBC , NE , and PLT ) were detected before chemotherapy , at day 7 , 10 , and 14 .
-METHODS	The TCM symptoms integrals , Karnofsky performance score ( KPS ) , liver and kidney functions were observed before chemotherapy , at day 7 and day 14 .
-METHODS	Adverse skin reactions were observed each day .
-METHODS	And the usage of hematopoietic growth factors was recorded .
-RESULTS	( 1 ) The KPS score at day 7 was more stable in the treatment group than in the control group ; the WBC and NE counts in the peripheral blood at day 14 were higher in the treatment group than in the control group ; and TCM symptoms integrals at day 14 was lower in the treatment group than in the control group , all with statistical difference ( P < 0.05 ) .
-RESULTS	( 2 ) Compared with the control group , the PLT count was higher in the treatment group than in the control group , the usage of rhG-CSF and antibiotics was less in the treatment group than in the control group , all with no statistical difference ( P > 0.05 ) .
-RESULTS	( 3 ) No obvious adverse reactions such as liver injury , renal injury , or skin allergy were observed .
-CONCLUSIONS	Adjuvant treatment of GEGC could improve carcinoma of the large intestine patients with myelosuppression to some extent .
-CONCLUSIONS	No relevant adverse reactions were found .
-
-###25272583
-BACKGROUND	The health system responsiveness , defined as non-medical aspect of treatment relating to the protection of the patients ' legitimate rights , is the intrinsic goal of the WHO strategy for 21st century .
-OBJECTIVE	To describe the patients ' opinions on treatment they received in hospital , namely : admission to hospital , the role of patient in hospital treatment , course of treatment , medical workforce attitude , hospital environment , contact with family and friends , and the efficacy of hospital treatment in respect to responsiveness to patient 's needs and expectations ( dignity , autonomy , confidentiality , communication , prompt attention , social support , basic amenities and choice of provider ) .
-METHODS	The data were collected in 2012 from 998 former patients of the randomly selected 73 hospital in Poland .
-RESULTS	Dignity : Over 80 % of patients experienced kindness , empathy , care and gentleness , and over 90 % of them had the sense of security in hospital , met with friendliness during the admission to hospital and never encountered inappropriate comments from medical staff .
-RESULTS	Autonomy : About 80 % of patients accepted the active role of patients in hospital , they perceived they had influence on procedures related to hospitalization and course of treatment , and they felt medical staff responded to their requests and concerns .
-RESULTS	Over 90 % of them had opportunity to communicate their concerns to medical staff and to discuss the course of treatment .
-RESULTS	On the other hand , the explanation of the reason for the refusal to meet their requests was given to only 23 % of the patients interested .
-RESULTS	Confidentiality : 70-80 % of patients declared the respect for privacy and confidentiality during collecting the health information and during medical examinations , and were not examined in presence of other people .
-RESULTS	Nevertheless , only 23 % of patients examined so were asked of their consent .
-RESULTS	Communication : About 90 % of patients declared they trusted their physician , received from him explanation regarding the course of treatment and information about further treatment after discharge from hospital , but physicians devoted the time and attention to only 70 % of them .
-RESULTS	Prompt attention : Over 90 % of patients perceived simplicity of the formalities of admission to hospital , and short waiting for treatment and additional tests in hospital ( but only 50 % received explanation of reason if they waited long ) .
-RESULTS	Nevertheless , 10 % of them % of them perceived they waited for admission to hospital too long , and over 20 % for admission to a ward as long .
-RESULTS	Social support : The unlimited direct and phone contact with family and friends was declared by 96 % of patients .
-RESULTS	Basic amenities : The high percentage of patients assessed positively the marking in hospital ( 97 % ) and cleanliness of linen ( 89 % ) , followed by the general indoor appearance room in which patient stayed , lack of noise ( 70-80 % ) , hospital meals , furniture ( 60-70 % ) , availability of personal hygienic articles ( 50-60 % ) , cleanliness of hospital room , toilet , showers and bathtubs , and availability of soap ( 40-50 % ) .
-RESULTS	Choice of provider : Only 41 % of patients declared that they had influence on choice of the hospital .
-CONCLUSIONS	Responsiveness of Polish hospital patient needs is similar to that of the OECD countries of the lowest health system responsiveness .
-CONCLUSIONS	Compared to the Central European countries , the responsiveness in Polish hospitals is lower than that of Czech Republic and only slightly higher of those of Slovenia , Slovakia and Hungary .
-
-###24405833
-BACKGROUND	Juvenile idiopathic arthritis ( JIA ) is the most common rheumatic disease in children .
-BACKGROUND	Children with JIA are at risk of inflammation of the uvea in the eye ( uveitis ) .
-BACKGROUND	Overall , 20 % to 25 % of paediatric uveitis is associated with JIA .
-BACKGROUND	Major risk factors for development of uveitis in JIA are oligoarticular pattern of arthritis , an age at onset of arthritis of less than seven years of age , and antinuclear antibody positivity .
-BACKGROUND	In the initial stages of mild to moderate inflammation the uveitis is asymptomatic .
-BACKGROUND	This has led to current practice of screening all children with JIA for uveitis .
-BACKGROUND	Approximately 12 % to 38 % of patients with JIA develop uveitis in seven years following onset of arthritis .
-BACKGROUND	In 30 % to 50 % of children with JIA-associated uveitis structural complications are present at diagnosis .
-BACKGROUND	Furthermore about 50 % to 75 % of those with severe uveitis will eventually develop visual impairment secondary to ocular complications such as cataract and glaucoma .
-BACKGROUND	Defining the severity of inflammation and structural complications in uveitis patients is now possible following Standardised Uveitis Nomenclature ( SUN ) guidelines , and modified to incorporate the consensus of end point and outcome criteria into the design of randomised trials .
-BACKGROUND	Despite current screening and therapeutic options ( pre-biologics ) 10 % to 15 % of children with JIA-associated uveitis may develop bilateral visual impairment and certified legally blind .
-BACKGROUND	To date , there remains no controlled trial evidence of benefits of biologic therapy .
-METHODS	This study will randomise 154 patients aged 2 to 18 years with active JIA-associated uveitis ( despite methotrexate ( MTX ) treatment for at least 12 weeks ) .
-METHODS	All participants will be treated for 18 months , with follow up of 3 years from randomisation ( continuing on MTX throughout ) .
-METHODS	All participants will receive a stable dose of MTX and in addition either adalimumab ( 20 mg/0 .8 ml for patients < 30 kg or 40 mg/0 .8 ml for patients weighing 30 kg or more , subcutaneous ( s/c ) injection every 2 weeks based on body weight ) , or placebo ( 0.8 ml as appropriate according to body weight ) s/c injection every 2 weeks .
-CONCLUSIONS	This is the first randomised controlled trial that will assess the clinical effectiveness , safety and cost effectiveness of adalimumab in combination with methotrexate for the treatment of juvenile idiopathic arthritis associated uveitis .
-BACKGROUND	ISRCTN10065623 .
-
-###24515505
-OBJECTIVE	To estimate the associations between autism spectrum disorder ( ASD ) diagnoses and service use , caregiver time , and cost outcomes .
-METHODS	We used national data from the Medical Expenditure Panel Survey linked to the National Health Interview Survey and a study-specific survey to estimate the annual utilization and costs for health care , school , ASD-related therapy , family-coordinated services , as well as caregiver time in children aged 3 to 17 years , with and without parent-reported ASD .
-METHODS	Regression analyses estimated the association between ASD diagnosis and cost , controlling for child gender , age , race/ethnicity , insurance status , household income , country region and urban/rural classification , and non-ASD-related illnesses .
-RESULTS	Children with parent-reported ASD had higher levels of health care office visits and prescription drug use compared with children without ASD ( P < .05 ) .
-RESULTS	A greater proportion of children in the ASD group used special educational services ( 76 % vs. 7 % in the control group , P < .05 ) .
-RESULTS	After adjusting for child demographic characteristics and non-ASD-associated illnesses , ASD was associated with $ 3020 ( 95 % confidence interval [ CI ] : $ 1017 - $ 4259 ) higher health care costs and $ 14,061 ( 95 % CI : $ 4390 - $ 24,302 ) higher aggregate non-health care costs , including $ 8610 ( 95 % CI : $ 6595 - $ 10,421 ) higher school costs .
-RESULTS	In adjusted analyses , parents who reported that their child had ASD did not have significantly higher out-of-pocket costs or spend more time on caregiving activities compared with control parents .
-CONCLUSIONS	The economic burden associated with ASD is substantial and can be measured across multiple sectors of our society .
-CONCLUSIONS	Previous analyses that focused on health care underestimated this economic burden , particularly for school systems .
-
-###24444682
-OBJECTIVE	To compare the two different nutritional supports , enteral nutrition and parenteral nutrition in the aspects of nutritional conditions , immune status , the incidence of perioperative complications and quality of life impacts in pancreatic cancer .
-METHODS	For the pancreatic cancer patients which pancreaticoduodenectomy were performed from January 2007 to December 2008 in five high-volume medical centres , prospective , randomized controlled study was carried out .
-METHODS	The enrolled patients were randomly divided into enteral nutritional group ( EN group ) and parenteral nutritional group ( PN group ) .
-METHODS	Related indicators , such as nutritional conditions , immune status , incidence of complications , general status and quality of life were assessed .
-RESULTS	The 200 patients were enrolled , while 178 cases which 90 patients in EN group and 88 patients in PN group were qualified to evaluate .
-RESULTS	The 22 cases were dropped out .
-RESULTS	For the mean hospital stay ( ( 23 13 ) days and ( 27 24 ) days respcectively ) , Karnofsky score and the life quality scoring , there are no statistical differences between the two groups .
-RESULTS	In post-operation day 7 and day 10 , the prealbumin was ( 69 16 ) mg/L and ( 80 22 ) mg/L in EN group and it was ( 67 19 ) mg/L and ( 70 11 ) mg/L in PN group , which are all significantly decreased than preoperational levels ( ( 186 38 ) mg/L for enteral group and ( 179 37 ) mg/L for parenteral group , t = -2.24 , -2.13 , -2.23 , -2.20 , all P < 0.05 ) , but there was no statistically significant between the 2 groups ( P > 0.05 ) .
-RESULTS	Other general indicators such as the albumin , hemoglobin , total bilirubin , blood urea nitrogen , serum creatinine , serum potassium and serum sodium , revealed no statistical differences in the 2 groups ( P > 0.05 ) ; The total lymphocytes , CD ( + ) 3CD ( + ) 4 and CD ( + ) 3CD ( + ) 8 lymphocytes in PN group was ( 0.687 0.065 ) 10 ( 9 ) / L , ( 0.363 0.029 ) 10 ( 9 ) / L , and ( 0.183 0.018 ) 10 ( 9 ) / L respectively in post-operation day 10 , which they are significantly decreased than in preoperational levels of PN group and the respective counterpart of EN group in post-operation day10 ( t = -2.04 -2.83 , P < 0.05 ) .
-RESULTS	The 35 patients were suffered from different complications in the 2 groups , but there was no statistical differences among them ( P > 0.05 ) .
-CONCLUSIONS	Enteral nutritional support could not decrease the incidence of perioperative complications in pancreatic cancer patient , but it can improve the immunonutrition status in comparison with parenteral nutrition .
-
-###25257928
-BACKGROUND	Clustering of outcomes at centers involved in multicenter trials is a type of center effect .
-BACKGROUND	The Consolidated Standards of Reporting Trials Statement recommends that multicenter randomized controlled trials ( RCTs ) should account for center effects in their analysis , however most do not .
-BACKGROUND	The Early External Cephalic Version ( EECV ) trials published in 2003 and 2011 stratified by center at randomization , but did not account for center in the analyses , and due to the nature of the intervention and number of centers , may have been prone to center effects .
-BACKGROUND	Using data from the EECV trials , we undertook an empirical study to compare various statistical approaches to account for center effect while estimating the impact of external cephalic version timing ( early or delayed ) on the outcomes of cesarean section , preterm birth , and non-cephalic presentation at the time of birth .
-METHODS	The data from the EECV pilot trial and the EECV2 trial were merged into one dataset .
-METHODS	Fisher 's exact method was used to test the overall effect of external cephalic version timing unadjusted for center effects .
-METHODS	Seven statistical models that accounted for center effects were applied to the data .
-METHODS	The models included : i ) the Mantel-Haenszel test , ii ) logistic regression with fixed center effect and fixed treatment effect , iii ) center-size weighted and iv ) un-weighted logistic regression with fixed center effect and fixed treatment-by-center interaction , iv ) logistic regression with random center effect and fixed treatment effect , v ) logistic regression with random center effect and random treatment-by-center interaction , and vi ) generalized estimating equations .
-RESULTS	For each of the three outcomes of interest approaches to account for center effect did not alter the overall findings of the trial .
-RESULTS	The results were similar for the majority of the methods used to adjust for center , illustrating the robustness of the findings .
-CONCLUSIONS	Despite literature that suggests center effect can change the estimate of effect in multicenter trials , this empirical study does not show a difference in the outcomes of the EECV trials when accounting for center effect .
-BACKGROUND	The EECV2 trial was registered on 30 July 30 2005 with Current Controlled Trials : ISRCTN 56498577 .
-
-###24526708
-BACKGROUND	Evidence supports peroneal nerve functional electrical stimulation ( FES ) as an effective alternative to ankle-foot orthoses ( AFO ) for treatment of foot drop poststroke , but few randomized controlled comparisons exist .
-OBJECTIVE	To compare changes in gait and quality of life ( QoL ) between FES and an AFO in individuals with foot drop poststroke .
-METHODS	In a multicenter randomized controlled trial ( ClinicalTrials.gov #NCT 01087957 ) with unblinded outcome assessments , 495 Medicare-eligible individuals at least 6 months poststroke wore FES or an AFO for 6 months .
-METHODS	Primary endpoints : 10-Meter Walk Test ( 10MWT ) , a composite of the Mobility , Activities of Daily Living/Instrumental Activities of Daily Living , and Social Participation subscores on the Stroke Impact Scale ( SIS ) , and device-related serious adverse event rate .
-METHODS	Secondary endpoints : 6-Minute Walk Test , GaitRite Functional Ambulation Profile ( FAP ) , Modified Emory Functional Ambulation Profile ( mEFAP ) , Berg Balance Scale ( BBS ) , Timed Up and Go , individual SIS domains , and Stroke-Specific Quality of Life measures .
-METHODS	Multiply imputed intention-to-treat analyses were used with primary endpoints tested for noninferiority and secondary endpoints tested for superiority .
-RESULTS	A total of 399 subjects completed the study .
-RESULTS	FES proved noninferior to the AFO for all primary endpoints .
-RESULTS	Both the FES and AFO groups improved significantly on the 10MWT .
-RESULTS	Within the FES group , significant improvements were found for SIS composite score , total mFEAP score , individual Floor and Obstacle course time scores of the mEFAP , FAP , and BBS , but again , no between-group differences were found .
-CONCLUSIONS	Use of FES is equivalent to the AFO .
-CONCLUSIONS	Further studies should examine whether FES enables better performance in tasks involving functional mobility , activities of daily living , and balance .
-
-###25033113
-OBJECTIVE	We evaluated changes in social capital following group-based cognitive processing therapy ( CPT ) for female survivors of sexual violence .
-METHODS	We compared CPT with individual support in a cluster-randomized trial in villages in South Kivu province , Democratic Republic of the Congo .
-METHODS	Local psychosocial assistants delivered the interventions from April through July 2011 .
-METHODS	We evaluated differences between CPT and individual support conditions for structural social capital ( i.e. , time spent with nonkin social network , group membership and participation , and the size of financial and instrumental support networks ) and emotional support seeking .
-METHODS	We analyzed intervention effects with longitudinal random effects models .
-RESULTS	We obtained small to medium effect size differences for 2 study outcomes .
-RESULTS	Women in the CPT villages increased group membership and participation at 6-month follow-up and emotional support seeking after the intervention compared with women in the individual support villages .
-CONCLUSIONS	Results support the efficacy of group CPT to increase dimensions of social capital among survivors of sexual violence in a low-income conflict-affected context .
-
-###25066654
-OBJECTIVE	Gut microbiota provides beneficial effects under physiological conditions , but is able to contribute to inflammatory diseases in susceptible individuals .
-OBJECTIVE	Thus , we designed this study to test whether additional intake of symbiotic gel affects specific modifications of gut microbiota in patients with end-stage renal disease ( ESRD ) .
-METHODS	Eighteen patients with ESRD diagnosis with renal replacement therapy ( hemodialysis ) were included in this study .
-METHODS	They were randomly assigned to 2 treatment groups : ( 1 ) test group ( nutritional counseling + symbiotic ) and ( 2 ) control group ( nutritional counseling + placebo ) .
-METHODS	Clinical history and the evaluation of Gastrointestinal Symptom Rating Scale were performed .
-METHODS	Gut microbiota composition was analyzed by real-time polymerase chain reaction from fecal samples .
-METHODS	All subjects were followed for 2months .
-RESULTS	Bifidobacterial counts were higher in the second samples ( mean : 5.51.72 log10 cells/g ) than in first samples ( 4.20.88 log 10cells/g ) in the patients of the test group ( P = .0344 ) .
-RESULTS	Also , lactobacilli counts had a little decrease in the test group ( 2.30.75 to 2.00.88 log 10 cells/g ) and the control group ( 2.20.90 to 1.81.33 log 10 cells/g ) , between the first and the second samples .
-RESULTS	Gastrointestinal symptoms scores ( scale 8-40 ) were reduced in the test group ( start 12 [ 10-14 ] and end 9 [ 8-10 ] ) compared with control group ( start 11 [ 8-21 ] and end 11 [ 9-15 ] ) .
-CONCLUSIONS	Short-term symbiotic treatment in patients with ESRD can lead to the increase of Bifidobacterium counts , maintaining the intestinal microbial balance .
-
-###25073879
-OBJECTIVE	A longitudinal integration approach evaluated all radiographic scores assessed over 10 years , rather than only completer data , from 2 studies of adalimumab ( ADA ) for rheumatoid arthritis ( RA ) .
-METHODS	The DE019 ( methotrexate [ MTX ] - inadequate responders , longstanding RA ) and PREMIER ( MTX-naive , early RA ) studies , respectively , had 1 - or 2-year double-blind periods followed by 9 - or 8-year open-label extensions ( OLEs ) .
-METHODS	Patients received ADA MTX in both OLEs .
-METHODS	Radiographic progression was assessed using change from baseline in modified total Sharp score ( mTSS ) .
-METHODS	A mixed-effects model was used post hoc to evaluate repeated measurements of different data campaigns and to estimate mTSS through up to 10 years of treatment based on original randomization groups ( placebo [ PBO ] + MTX or standard dose ADA + MTX ) .
-RESULTS	Data from patients with baseline and 1 postbaseline radiograph were included ( n = 327 for DE019 ; n = 452 for PREMIER ) .
-RESULTS	Integrated and 10-year completer mTSS progression curves differed slightly .
-RESULTS	In DE019 , for patients originally assigned PBO + MTX , accrued mTSS at year 10 was 6.6 units ( integrated model ) and 6.2 units ( completers ) .
-RESULTS	For patients originally assigned ADA + MTX , accrued mTSS was 0.9 units by integrated analysis and 0.7 units in completers .
-RESULTS	In PREMIER , for patients originally assigned PBO + MTX , accrued mTSS at year 10 was 11.2 units ( integrated analysis ) and 11.0 units ( completers ) .
-RESULTS	For patients originally assigned ADA + MTX , accrued mTSS was 5.1 units ( integrated analysis ) and 4.0 units ( completers ) .
-RESULTS	A higher radiographic progression rate was observed in patients who received delayed versus immediate ADA + MTX treatment .
-CONCLUSIONS	Longitudinal integrated analysis provided robust estimates of radiographic progression that only slightly differed from completers-only scores and confirmed the effects .
-
-###24511017
-OBJECTIVE	We aimed to investigate the clinical significance of the activation of Yes-Associated Protein 1 ( YAP1 ) , a key downstream effector of Hippo tumor-suppressor pathway , in ovarian cancer .
-METHODS	A gene expression signature reflecting activation of YAP1 was developed from gene expression data of 267 samples from patients with ovarian cancer .
-METHODS	A refined ovarian cancer YAP1 signature was validated in an independent ovarian cancer cohort ( n = 185 ) .
-METHODS	Associations between the YAP1 signature and prognosis were assessed using Kaplan-Meier plots , the log-rank test , and a Cox proportional hazards model .
-RESULTS	We identified a 612-gene expression signature reflecting YAP1 activation in ovarian cancer .
-RESULTS	In multivariate analysis , the signature was an independent predictor of overall survival ( hazard ratio = 1.66 ; 95 % confidence interval = 1.1 to 2.53 ; p = 0.01 ) .
-RESULTS	In subset analysis , the signature identified patients likely to benefit from taxane-based adjuvant chemotherapy .
-CONCLUSIONS	Activation of YAP1 is significantly associated with prognosis and the YAP1 signature can predict response to taxane-based adjuvant chemotherapy in patients with ovarian cancer .
-
-###25646321
-BACKGROUND	Epidemiology associates whole-grain ( WG ) consumption with several health benefits .
-BACKGROUND	Mounting evidence suggests that WG wheat polyphenols play a role in mechanisms underlying health benefits .
-OBJECTIVE	The objective was to assess circulating concentration , excretion , and the physiologic role of WG wheat polyphenols in subjects with suboptimal dietary and lifestyle behaviors .
-METHODS	A placebo-controlled , parallel-group randomized trial with 80 healthy overweight/obese subjects with low intake of fruit and vegetables and sedentary lifestyle was performed .
-METHODS	Participants replaced precise portions of refined wheat ( RW ) with a fixed amount of selected WG wheat or RW products for 8 wk .
-METHODS	At baseline and every 4 wk , blood , urine , feces , and anthropometric and body composition measures were collected .
-METHODS	Profiles of phenolic acids in biological samples , plasma markers of metabolic disease and inflammation , and fecal microbiota composition were assessed .
-RESULTS	WG consumption for 4-8 wk determined a 4-fold increase in serum dihydroferulic acid ( DHFA ) and a 2-fold increase in fecal ferulic acid ( FA ) compared with RW consumption ( no changes ) .
-RESULTS	Similarly , urinary FA at 8 wk doubled the baseline concentration only in WG subjects .
-RESULTS	Concomitant reduction in plasma tumor necrosis factor - ( TNF - ) after 8 wk and increased interleukin ( IL ) -10 only after 4 wk with WG compared with RW ( P = 0.04 ) were observed .
-RESULTS	No significant change in plasma metabolic disease markers over the study period was observed , but a trend toward lower plasma plasminogen activator inhibitor 1 with higher excretion of FA and DHFA in the WG group was found .
-RESULTS	Fecal FA was associated with baseline low Bifidobacteriales and Bacteroidetes abundances , whereas after WG consumption , it correlated with increased Bacteroidetes and Firmicutes but reduced Clostridium .
-RESULTS	TNF - reduction correlated with increased Bacteroides and Lactobacillus .
-RESULTS	No effect of dietary interventions on anthropometric measurements and body composition was found .
-CONCLUSIONS	WG wheat consumption significantly increased excreted FA and circulating DHFA .
-CONCLUSIONS	Bacterial communities influenced fecal FA and were modified by WG wheat consumption .
-CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01293175 .
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-###25102847
-BACKGROUND	Diarrhoea and respiratory infections are the two biggest causes of child death globally .
-BACKGROUND	Handwashing with soap could substantially reduce diarrhoea and respiratory infections , but prevalence of adequate handwashing is low .
-BACKGROUND	We tested whether a scalable village-level intervention based on emotional drivers of behaviour , rather than knowledge , could improve handwashing behaviour in rural India .
-METHODS	The study was done in Chittoor district in southern Andhra Pradesh , India , between May 24 , 2011 , and Sept 10 , 2012 .
-METHODS	Eligible villages had a population of 700-2000 people , a state-run primary school for children aged 8-13 years , and a preschool for children younger than 5 years .
-METHODS	14 villages ( clusters ) were selected , stratified by population size ( < 1200 vs > 1200 ) , and randomly assigned in a 1:1 ratio to intervention or control ( no intervention ) .
-METHODS	Clusters were enrolled by the study manager .
-METHODS	Random allocation was done by the study statistician using a random number generator .
-METHODS	The intervention included community and school-based events incorporating an animated film , skits , and public pledging ceremonies .
-METHODS	Outcomes were measured by direct observation in 20-25 households per village at baseline and at three follow-up visits ( 6 weeks , 6 months , and 12 months after the intervention ) .
-METHODS	Observers had no connection with the intervention and observers and participant households were told that the study was about domestic water use to reduce the risk of bias .
-METHODS	No other masking was possible .
-METHODS	The primary outcome was the proportion of handwashing with soap at key events ( after defecation , after cleaning a child 's bottom , before food preparation , and before eating ) at all follow-up visits .
-METHODS	The control villages received a shortened version of the intervention before the final follow-up round .
-METHODS	Outcome data are presented as village-level means .
-RESULTS	Handwashing with soap at key events was rare at baseline in both the intervention and control groups ( 1 % [ SD 1 ] vs 2 % [ 1 ] ) .
-RESULTS	At 6 weeks ' follow-up , handwashing with soap at key events was more common in the intervention group than in the control group ( 19 % [ SD 21 ] vs 4 % [ 2 ] ; difference 15 % , p = 0005 ) .
-RESULTS	At the 6-month follow-up visit , the proportion handwashing with soap was 37 % ( SD 7 ) in the intervention group versus 6 % ( 3 ) in the control group ( difference 31 % ; p = 002 ) .
-RESULTS	At the 12-month follow-up visit , after the control villages had received the shortened intervention , the proportion handwashing with soap was 29 % ( SD 9 ) in the intervention group and 29 % ( 13 ) in the control group .
-CONCLUSIONS	This study shows that substantial increases in handwashing with soap can be achieved using a scalable intervention based on emotional drivers .
-BACKGROUND	Wellcome Trust , SHARE .
-
-###24480956
-METHODS	A prospective , randomized , and double-blind study .
-OBJECTIVE	To compare the efficacy of ramosetron and palonosetron on preventing postoperative nausea and vomiting ( PONV ) associated with opioid-based intravenous patient-controlled analgesia ( IV-PCAopioid ) after lumbar spinal surgery .
-BACKGROUND	IV-PCAopioid , an effective method to control pain after lumbar spinal surgery , accompanies PONV .
-BACKGROUND	Ramosetron and palonosetron are novel 5-hydroxytryptamine 3 antagonists known to have longer action duration and higher receptor affinity than their congeners , whereas their relative efficacy has not been validated yet .
-METHODS	One hundred ninety-six patients were randomly and evenly allocated to receive either 0.3 mg of ramosetron or 0.075 mg of palonosetron 10 minutes before the end of operation .
-METHODS	Ramosetron or palonosetron were also added to the IV-PCAopioid , which was continuously infused for 48 hours postoperatively .
-METHODS	The incidence and intensity of PONV were serially assessed for 72 hours postoperatively .
-METHODS	Intensity of pain , volume of IV-PCAopioid consumption , use of rescue analgesics and antiemetics , and adverse events were also assessed .
-RESULTS	The overall incidence of PONV was lower in the ramosetron group than the palonosetron group ( 50 % vs. 67 % , P = 0.014 ) without any intergroup difference in the incidence of vomiting .
-RESULTS	Nausea intensity scores were also lower until 6 ( P = 0.041 ) and 24 hour ( P = 0.026 ) postoperatively in the ramosetron group than the palonosetron group .
-RESULTS	Pain intensity scores were significantly lower in the ramosetron group than the palonosetron group for 72 hours postoperatively .
-CONCLUSIONS	Ramosetron was superior to palonosetron in term of reducing the incidence and severity of nausea associated with IV-PCAopioid after lumbar spinal surgery .
-CONCLUSIONS	This favorable influence of ramosetron on PONV was translated to significant postoperative pain reduction compared with palonosetron .
-METHODS	1 .
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-###25798575
-OBJECTIVE	For patients with limited prognosis , some medication risks may outweigh the benefits , particularly when benefits take years to accrue ; statins are one example .
-OBJECTIVE	Data are lacking regarding the risks and benefits of discontinuing statin therapy for patients with limited life expectancy .
-OBJECTIVE	To evaluate the safety , clinical , and cost impact of discontinuing statin medications for patients in the palliative care setting .
-METHODS	This was a multicenter , parallel-group , unblinded , pragmatic clinical trial .
-METHODS	Eligibility included adults with an estimated life expectancy of between 1 month and 1 year , statin therapy for 3 months or more for primary or secondary prevention of cardiovascular disease , recent deterioration in functional status , and no recent active cardiovascular disease .
-METHODS	Participants were randomized to either discontinue or continue statin therapy and were monitored monthly for up to 1 year .
-METHODS	The study was conducted from June 3 , 2011 , to May 2 , 2013 .
-METHODS	All analyses were performed using an intent-to-treat approach .
-METHODS	Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group .
-METHODS	Patients in the continuation group continued to receive statins .
-METHODS	Outcomes included death within 60 days ( primary outcome ) , survival , cardiovascular events , performance status , quality of life ( QOL ) , symptoms , number of nonstatin medications , and cost savings .
-RESULTS	A total of 381 patients were enrolled ; 189 of these were randomized to discontinue statins , and 192 were randomized to continue therapy .
-RESULTS	Mean ( SD ) age was 74.1 ( 11.6 ) years , 22.0 % of the participants were cognitively impaired , and 48.8 % had cancer .
-RESULTS	The proportion of participants in the discontinuation vs continuation groups who died within 60 days was not significantly different ( 23.8 % vs 20.3 % ; 90 % CI , -3.5 % to 10.5 % ; P = .36 ) and did not meet the noninferiority end point .
-RESULTS	Total QOL was better for the group discontinuing statin therapy ( mean McGill QOL score , 7.11 vs 6.85 ; P = .04 ) .
-RESULTS	Few participants experienced cardiovascular events ( 13 in the discontinuation group vs 11 in the continuation group ) .
-RESULTS	Mean cost savings were $ 3.37 per day and $ 716 per patient .
-CONCLUSIONS	This pragmatic trial suggests that stopping statin medication therapy is safe and may be associated with benefits including improved QOL , use of fewer nonstatin medications , and a corresponding reduction in medication costs .
-CONCLUSIONS	Thoughtful patient-provider discussions regarding the uncertain benefit and potential decrement in QOL associated with statin continuation in this setting are warranted .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01415934 .
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-###24418164
-BACKGROUND	Several studies have shown that unnecessary right ventricular pacing has detrimental effects .
-OBJECTIVE	To evaluate whether minimization of ventricular pacing as compared with standard dual-chamber pacing ( DDD ) improves clinical outcomes in patients referred for pacemaker or implantable cardioverter-defibrillator ( ICD ) replacement .
-METHODS	In an international single-blind , multicenter , randomized controlled trial , we compared DDD with managed ventricular pacing ( MVP ) , a pacing mode developed to minimize ventricular pacing by promoting intrinsic atrioventricular conduction .
-METHODS	We included patients referred for device replacement with > 40 % ventricular pacing , no cardiac resynchronization therapy upgrade indication , no permanent atrial fibrillation ( AF ) , and no permanent complete atrioventricular block .
-METHODS	Follow-up was for 2 years .
-METHODS	The primary end point was cardiovascular hospitalization .
-METHODS	The intention-to-treat analysis was performed by using Kaplan-Meier method and the log-rank test .
-RESULTS	We randomized 605 patients ( 556 referred for pacemaker and 49 referred for ICD replacement ; mean age 75 11 years ; 365 [ 60 % ] men , at 7.7 3.3 years from first device implantation ) to MVP ( n = 299 ) or DDD ( n = 306 ) .
-RESULTS	We found no significant differences in the primary end point cardiovascular hospitalization ( MVP : 16.3 % vs DDD : 14.5 % ; P = .72 ) and the secondary end point persistent AF ( MVP : 15.4 % vs DDD : 11.2 % ; P = .08 ) , permanent AF ( MVP : 4.1 % vs DDD : 3.1 % ; P = .44 ) , and composite of death and cardiovascular hospitalization ( MVP : 23.9 % vs DDD : 20.2 % ; P = .48 ) .
-RESULTS	MVP reduced right ventricular pacing ( median 5 % vs 86 % ; Wilcoxon , P < .0001 ) as compared with DDD .
-CONCLUSIONS	In patients referred for pacemaker and ICD replacement with clinically well-tolerated long-term exposure to > 40 % ventricular pacing in the ventricle , a strategy to minimize ventricular pacing is not superior to standard DDD in reducing incidence of cardiovascular hospitalizations .
-
-###25006633
-OBJECTIVE	To compare gadobenate dimeglumine-enhanced magnetic resonance imaging ( MRI ) with gadopentetate dimeglumine-enhanced MRI , mammography , and ultrasound for breast cancer detection across different malignant lesion types and across different densities of breast tissue .
-METHODS	In all , 153 women with Breast Imaging Reporting and Data System ( BI-RADS ) 35 findings on mammography and/or ultrasound underwent identical breast MRI exams at 1.5 T with gadobenate dimeglumine and gadopentetate dimeglumine .
-METHODS	Images were evaluated by three independent blinded radiologists .
-METHODS	Mammography , ultrasound , and combined mammography and/or ultrasound findings were available for 108 , 109 , and 131 women .
-METHODS	Imaging findings were matched with histology data by a fourth , independent , blinded radiologist .
-METHODS	Malignant lesion detection rates and diagnostic performance were compared .
-RESULTS	In all , 120 , 120 , and 140 confirmed malignant lesions were present in patients undergoing MRI + mammography , MRI + ultrasound , and MRI + mammography and/or ultrasound , respectively .
-RESULTS	Significantly greater cancer detection rates were noted by all three readers for comparisons of gadobenate dimeglumine-enhanced MRI with mammography ( 15.817.5 % ; P < 0.0001 ) , ultrasound ( 18.320.0 % ; P < 0.0001 ) , and mammography and/or ultrasound ( 8.610.7 % ; P 0.0105 ) but not for comparisons of gadopentetate dimeglumine-enhanced MRI with conventional techniques ( P > 0.05 ) .
-RESULTS	The false-positive detection rates were lower on gadobenate dimeglumine-enhanced MRI than on conventional imaging ( 4.05.5 % vs. 11.1 % at mammography ; 6.38.4 % vs. 15.5 % at ultrasound ) .
-RESULTS	Significantly improved cancer detection on MRI was noted in heterogeneously dense breast ( 91.297.3 % on gadobenate dimeglumine-enhanced MRI vs. 77.284.9 % on gadopentetate dimeglumine-enhanced MRI vs. 71.9-84 .9 % with conventional techniques ) and for invasive cancers ( 93.296.2 % for invasive ductal carcinoma [ IDC ] on gadobenate dimeglumine-enhanced MRI vs. 79.788.5 % on gadopentetate dimeglumine-enhanced MRI vs. 77.084.4 % with conventional techniques ) .
-RESULTS	Overall diagnostic performance for the detection of cancer was superior on gadobenate dimeglumine-enhanced MRI than on conventional imaging or gadopentetate dimeglumine-enhanced MRI .
-CONCLUSIONS	Gadobenate dimeglumine-enhanced MRI significantly improves cancer detection compared to gadopentetate dimeglumine-enhanced MRI , mammography , and ultrasound in a selected group of patients undergoing breast MRI for preoperative staging or because of inconclusive findings at conventional imaging .
-
-###24961091
-OBJECTIVE	To observe the efficacy of combined use of brimonidine and betaxolol in treatment of primary open angle glaucoma ( POAG ) and ocular hypertension .
-METHODS	A total of 54 patients ( 90 eyes ) with POAG and ocular hypertension were randomly divided into three groups ( receiving betaxolol , brimonidine and combined administration of betaxolol and brimonidine respectively ) .
-METHODS	The administration was given twice daily in all groups ( 0.5 % betaxolol , 0.2 % brimonidine and 0.5 % betaxolol combined with 0.2 % brimonidine ) .
-METHODS	The changes in intraocular pressure ( IOP ) were observed before , and 2 , 4 , 6 , and 8 weeks after treatment .
-METHODS	In addition , the adverse reactions were also recorded post-treatment .
-RESULTS	The mean IOPs at all the time points after treatment were significantly reduced compared with pre-treatment levels ( P < 0.05 ) .
-RESULTS	Patients receiving brimonidine had a greater reduction in IOP compared with their counterparts in the betaxolol group but the difference was not statistically significant .
-RESULTS	The IOP decline was significantly higher in the combined therapy group than in the other two groups ( P < 0.01 ) .
-RESULTS	Few cases presented with slight discomfort , such as sensation of foreign bodies , ocular irritation , dizziness , headache , fatigue , and dryness of mouth and nose .
-RESULTS	No severe adverse reactions were noted following administration .
-CONCLUSIONS	Combined use of brimonidine and betaxolol is an efficacious treatment of reducing IOP without severe side effects .
-
-###25160493
-OBJECTIVE	Calcium aluminosilicate clay ( CASAD ) is a naturally occurring clay that serves as a cation exchange absorbent .
-OBJECTIVE	We hypothesized that oral administration of CASAD would reduce the rate of grade 3/4 diarrhea associated with irinotecan use for metastatic colorectal cancer ( CRC ) by adsorbing the SN-38 metabolite .
-METHODS	Patients receiving irinotecan-based chemotherapy were randomized equally between CASAD and placebo arms in this multicenter trial in order to assess differences in the proportions of patients with grade 3/4 diarrhea within 6 weeks .
-METHODS	Additionally , we compared symptom severity between the two arms using the M.D. Anderson Symptom Inventory .
-RESULTS	Between May 2009 and May 2012 , 100 patients were enrolled .
-RESULTS	In evaluable patients , 7 of 43 ( 16 % ) on the CASAD arm compared to 3 of 32 ( 9 % ) on the placebo arm experienced grade 3/4 diarrhea ( P = 0.70 ) .
-RESULTS	The rate of any diarrhea among all patients was similar ( CASAD arm , 64 % vs. placebo arm , 70 % ) .
-RESULTS	The rate of study dropout was 14 % in the CASAD arm and 38 % in the placebo arm ( P = 0.01 ) .
-RESULTS	No differences were found in symptom severity , individual symptom items , and in serious adverse events between the two arms .
-CONCLUSIONS	Compared to placebo , CASAD use was safe but ineffective in preventing diarrhea in metastatic CRC patients treated with irinotecan-containing chemotherapy regimens .
-CONCLUSIONS	There were no distinct signals in terms of patient symptoms between arms , but there was significantly more patient dropout in the placebo arm .
-CONCLUSIONS	Future CASAD trials will focus on the active treatment of diarrhea .
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-###24937643
-BACKGROUND	Pulmonary hypertension ( PH ) associated with fibrotic idiopathic interstitial pneumonia ( IIP ; idiopathic pulmonary fibrosis and nonspecific interstitial pneumonia ) confers important additional morbidity and mortality .
-OBJECTIVE	To evaluate the safety and clinical efficacy of the dual endothelin-1 receptor antagonist bosentan in this patient group .
-METHODS	In a randomized , double-blind , placebo-controlled study , 60 patients with fibrotic IIP and right heart catheter confirmed PH were randomized 2:1 to bosentan ( n = 40 ) or placebo ( n = 20 ) .
-METHODS	The primary study endpoint was a fall from baseline pulmonary vascular resistance index ( PVRi ) of 20 % or more over 16 weeks .
-RESULTS	Sixty patients ( 42 men ; mean age , 66.6 9.2 yr ) , with a mean pulmonary artery pressure of 36.0 ( 8.9 ) mm Hg , PVRi 13.0 ( 6.7 ) Wood Units/m ( 2 ) and reduced cardiac index of 2.21 ( 0.5 ) L/min/m ( 2 ) were recruited to the study .
-RESULTS	Accounting for deaths and withdrawals , paired right heart catheter data were available for analysis in 39 patients ( bosentan = 25 , placebo = 14 ) .
-RESULTS	No difference in the primary outcome was detected , with seven ( 28.0 % ) patients receiving bosentan , and four ( 28.6 % ) receiving placebo achieving a reduction in PVRi of greater than or equal to 20 % ( P = 0.97 ) at 16 weeks .
-RESULTS	There was no change in functional capacity or symptoms between the two groups at 16 weeks , nor any difference in rates of serious adverse events or deaths ( three deaths in each group ) .
-CONCLUSIONS	This study shows no difference in invasive pulmonary hemodynamics , functional capacity , or symptoms between the bosentan and placebo groups over 16 weeks .
-CONCLUSIONS	Our data do not support the use of the dual endothelin-1 receptor antagonist , bosentan , in patients with PH and fibrotic IIP .
-CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 00637065 ) .
-
-###24798770
-BACKGROUND	The integrase inhibitor dolutegravir and nucleoside analogues abacavir and lamivudine are once-daily treatment options for HIV .
-BACKGROUND	This study ( NCT01622790 ) evaluated , first , the bioequivalence ( BE ) of a fixed-dose combination ( FDC ) tablet containing dolutegravir 50 mg , abacavir 600 mg , and lamivudine 300 mg ( dolutegravir/abacavir/lamivudine FDC ) vs coadministered dolutegravir 50 mg and abacavir/lamivudine combination tablets ( Epzicom ) and , second , the effect of food on the dolutegravir/abacavir/lamivudine FDC tablet .
-METHODS	Study part A ( 66 healthy subjects ) was a single-dose , open-label , randomized , 2-period crossover study to evaluate the BE of the dolutegravir/abacavir/lamivudine FDC tablet and dolutegravir + abacavir/lamivudine tablets in the fasted state .
-METHODS	In study part B , 12 subjects from part A received the dolutegravir/abacavir/lamivudine FDC tablet with a high-fat meal .
-METHODS	BE and food effect were assessed by analysis of variance to determine the ratio of geometric least squares means and associated 90 % confidence intervals for key pharmacokinetic parameters for each of dolutegravir , abacavir , and lamivudine .
-RESULTS	Sixty-two subjects completed part A.
-RESULTS	The dolutegravir/abacavir/lamivudine tablet was bioequivalent to the dolutegravir + abacavir/lamivudine tablets ; 90 % confidence intervals for the geometric least squares mean ratios fell within the 0.8-1 .25 BE criteria .
-RESULTS	The effect of food on the dolutegravir/abacavir/lamivudine FDC tablet was similar to previous food effects observed with the separate formulations .
-RESULTS	The safety profile was comparable between treatments , with no observed serious or grade 3/4 adverse events .
-CONCLUSIONS	The BE of the dolutegravir/abacavir/lamivudine FDC tablet was demonstrated ; it may be administered without regard to meals .
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-###25620670
-OBJECTIVE	Crohn 's disease ( CD ) usually recurs after intestinal resection ; postoperative endoscopic monitoring and tailored treatment can reduce the chance of recurrence .
-OBJECTIVE	We investigated whether monitoring levels of fecal calprotectin ( FC ) can substitute for endoscopic analysis of the mucosa .
-METHODS	We analyzed data collected from 135 participants in a prospective , randomized , controlled trial , performed at 17 hospitals in Australia and 1 hospital in New Zealand , that assessed the ability of endoscopic evaluations and step-up treatment to prevent CD recurrence after surgery .
-METHODS	Levels of FC , serum levels of C-reactive protein ( CRP ) , and Crohn 's disease activity index ( CDAI ) scores were measured before surgery and then at 6 , 12 , and 18 months after resection of all macroscopic Crohn 's disease .
-METHODS	Ileocolonoscopies were performed at 6 months after surgery in 90 patients and at 18 months after surgery in all patients .
-RESULTS	Levels of FC were measured in 319 samples from 135 patients .
-RESULTS	The median FC level decreased from 1347 g/g before surgery to 166 g/g at 6 months after surgery , but was higher in patients with disease recurrence ( based on endoscopic analysis ; Rutgeerts score , i2 ) than in patients in remission ( 275 vs 72 g/g , respectively ; P < .001 ) .
-RESULTS	Combined 6 - and 18-month levels of FC correlated with the presence ( r = 0.42 ; P < .001 ) and severity ( r = 0.44 ; P < .001 ) of CD recurrence , but the CRP level and CDAI score did not .
-RESULTS	Levels of FC greater than 100 g/g indicated endoscopic recurrence with 89 % sensitivity and 58 % specificity , and a negative predictive value ( NPV ) of 91 % ; this means that colonoscopy could have been avoided in 47 % of patients .
-RESULTS	Six months after surgery , FC levels less than 51 g/g in patients in endoscopic remission predicted maintenance of remission ( NPV , 79 % ) .
-RESULTS	In patients with endoscopic recurrence at 6 months who stepped-up treatment , FC levels decreased from 324 g/g at 6 months to 180 g/g at 12 months and 109 g/g at 18 months .
-CONCLUSIONS	In this analysis of data from a prospective clinical trial , FC measurement has sufficient sensitivity and NPV values to monitor for CD recurrence after intestinal resection .
-CONCLUSIONS	Its predictive value might be used to identify patients most likely to relapse .
-CONCLUSIONS	After treatment for recurrence , the FC level can be used to monitor response to treatment .
-CONCLUSIONS	It predicts which patients will have disease recurrence with greater accuracy than CRP level or CDAI score .
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-###24625010
-BACKGROUND	Systematic use of observational pain tools has been advocated as a means to improve pain management for care home residents with dementia .
-BACKGROUND	Pain experts suggest that any observational tool should be used as part of a comprehensive pain management protocol , which should include score interpretation and verification with appropriately suggested treatments .
-BACKGROUND	The Observational Pain Management Protocol ( Protocol ) was therefore developed .
-BACKGROUND	This study aims to investigate the extent to which the implementation of this Protocol can improve pain management in care home residents with dementia .
-METHODS	In this two-group , single-blinded , cluster-randomized controlled trial , 122 care home residents with dementia and pain-related diagnoses will be recruited from eight care homes ( that is 15 to 16 residents from each care home ) .
-METHODS	Invitations will be sent to all local care homes who meet the home selection criteria .
-METHODS	The eight care homes will be randomly selected from all care homes that agree to join this trial .
-METHODS	They will then be randomized to either the control or experimental conditions .
-METHODS	Participants from each care home will be placed into their home 's corresponding group to avoid ` contamination ' effects across participants .
-METHODS	Each intervention cycle will take 16 weeks ( that is , baseline assessment and care home staff training for 4 weeks and Protocol implementation for 12 weeks ) .
-METHODS	The Protocol will guide the pain management of the participants in the experimental care homes .
-METHODS	Meanwhile , the control care homes will continue their usual pain management strategies .
-METHODS	Intervention effects will be measured weekly during the protocol implementation period and compared with the baseline measurements , as well as between the experimental and control conditions .
-CONCLUSIONS	Although similar pain protocols have been suggested previously , the recommendations were based on experts ' opinions rather than evaluation of research studies .
-CONCLUSIONS	The feasibility and effectiveness of this kind of pain management protocol , tailored to older people with dementia , remains unknown .
-CONCLUSIONS	The findings of this trial will offer strong evidence that better strategies for pain management should be used in the care home daily routine .
-BACKGROUND	The Chinese University of Hong Kong , Centre for Clinical Trials : CUHK-CCT00367 .
-
-###24628553
-BACKGROUND	Dietary protein digestion and absorption is an important factor modulating muscle protein accretion .
-BACKGROUND	However , there are few data available on the effects of coingesting other macronutrients with protein on digestion and absorption kinetics and the subsequent muscle protein synthetic response .
-OBJECTIVE	The objective of the study was to determine the impact of carbohydrate coingestion with protein on dietary protein digestion and absorption and muscle protein accretion in healthy young and older men .
-METHODS	Twenty-four healthy young ( aged 21 1 y , body mass index 21.8 0.5 kg/m ( 2 ) ) and 25 older ( aged 75 1 y , body mass index 25.4 0.6 kg/m ( 2 ) ) men received a primed continuous L - [ ring - ( 2 ) H5 ] - phenylalanine and L - [ ring-3 ,5 - ( 2 ) H2 ] - tyrosine infusion and ingested 20 g intrinsically L - [ 1 - ( 13 ) C ] - phenylalanine-labeled protein with ( Pro + CHO ) or without ( Pro ) 60 g carbohydrate .
-METHODS	Plasma samples and muscle biopsies were collected in a postabsorptive and postprandial state .
-RESULTS	Carbohydrate coingestion delayed the appearance of exogenous phenylalanine in the circulation ( P = .001 ) .
-RESULTS	Dietary protein-derived phenylalanine availability over the 5-hour postprandial period was lower in the older ( 62 2 % ) when compared with the young subjects ( 74 2 % ; P = .007 ) , with no differences between conditions ( P = .20 ) .
-RESULTS	Carbohydrate coingestion did not modulate postprandial muscle protein synthesis rates ( 0.035 0.003 vs 0.043 0.004 and 0.033 0.002 vs 0.035 0.003 % / h after Pro vs Pro + CHO in the young and older group , respectively ) .
-RESULTS	In accordance , no differences in muscle protein-bound L - [ 1 - ( 13 ) C ] - phenylalanine enrichments were observed between conditions ( 0.020 0.002 vs 0.020 0.002 and 0.019 0.003 vs 0.022 0.004 mole percent excess after Pro vs Pro + CHO in the young and older subjects , respectively ) .
-CONCLUSIONS	Carbohydrate coingestion with protein delays dietary protein digestion and absorption but does not modulate postprandial muscle protein accretion in healthy young or older men .
-
-###24460223
-OBJECTIVE	Intrusive thoughts and images are common across the adult lifespan , but vary in their consequences .
-OBJECTIVE	Understanding age-related experiences with intrusive thoughts is important for identifying risk and protective factors for intrusive thought problems across the adult lifespan .
-OBJECTIVE	This study characterized age trajectories for six aspects of experiences with intrusive thoughts using Internet data collection .
-METHODS	Participants ( N = 1427 ; ages 18-87 ) were randomly assigned to suppress ( i.e. keep out of mind ) or monitor an intrusive thought for one minute , and then later to monitor the thought for a second minute .
-METHODS	Participants tracked thought recurrences during each thinking period , then reported their positive and negative affects following each thinking period , as well as their effort expended in suppressing the thought and perceived difficulty controlling the intrusive thought .
-METHODS	Multilevel modeling and generalized estimating equations modeled the continuous relationships between age and each dependent variable .
-RESULTS	As expected , older age was associated with less decline in positive affect while engaging with an intrusive thought .
-RESULTS	Interestingly , older age was also associated with a sharper rise and fall of negative affect .
-RESULTS	Suppression effort increased linearly with age ( though perceived difficulty did not ) .
-RESULTS	Finally , no age differences were found in either the frequency or duration of the thought 's recurrence , adding to previous evidence that older adults function similarly to younger adults in their control of intrusive thoughts , despite certain age-related declines in cognitive functioning .
-CONCLUSIONS	These findings suggest a dissociation between age-related changes in emotional versus cognitive characteristics of engaging with intrusive thoughts .
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-###24659510
-BACKGROUND	Screening to prevent sudden cardiac death remains a contentious topic in sport and exercise medicine .
-BACKGROUND	The aim of this study was to assess whether the use of a standardised criteria tool improves the accuracy of ECG interpretation by physicians screening athletes .
-METHODS	Design : Randomised control trial .
-METHODS	Study Population : General practitioners with an interest in sports medicine , sports physicians , sports medicine registrars and cardiologists from Australia and New Zealand were eligible to participate .
-METHODS	Outcome Measures : Accuracy , sensitivity , specificity and false-positive rates of screening ECG interpretation of athletes .
-METHODS	Intervention : A two-page standardised ECG criteria tool was provided to intervention participants .
-METHODS	Control participants undertook ` usual ' interpretation .
-RESULTS	62 physicians , with a mean duration of practice of 16years , were randomised to intervention and control .
-RESULTS	10 baseline and 30 postrandomisation athlete ECGs were interpreted by the participants .
-RESULTS	Intervention participants were more likely to be correct : OR 1.72 ( 95 % CI 1.31 to 2.27 , p < 0.001 ) .
-RESULTS	Correct ECG interpretation was higher in the intervention group , 88.4 % ( 95 % CI 85.7 % to 91.2 % ) , than in the control group , 82.2 % ( 95 % CI 78.8 % to 85.5 % ; p = 0.005 ) .
-RESULTS	Sensitivity was 95 % in the intervention group and 92 % in the control group ( p = 0.4 ) , with specificity of 86 % and 78 % , respectively ( p = 0.006 ) .
-RESULTS	There were 36 % fewer false positives in the intervention group ( p = 0.006 ) .
-CONCLUSIONS	ECG interpretation in athletes can be improved by using a standardised ECG criteria tool .
-CONCLUSIONS	Use of the tool results in lower false-positive rates ; this may have implications for screening recommendations .
-BACKGROUND	ACTRN12612000641897 .
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-###24288077
-OBJECTIVE	Anterior knee pain is a major cause of complaint in total knee arthroplasty ( TKA ) without patellar resurfacing .
-OBJECTIVE	The concept of improved patellar tracking and decreased retropatellar contact pressure for lateral retinacular release theoretically suggests that patients with lateral retinacular release in TKA would achieve a lower incidence of anterior knee pain when compared without lateral retinacular release .
-OBJECTIVE	We sought to determine ( 1 ) whether those patients who received a routine lateral retinacular release in TKA would attain lower incidence of anterior knee pain as compared to patients who received TKA without lateral retinacular release and ( 2 ) whether lateral retinacular release would increase the lateral retinacular release-related complications .
-METHODS	A total of 148 patients who underwent TKA with the use of the Gemini MK II mobile bearing were randomized to receive either routine lateral retinacular release ( intervention group ) or not ( control group ) .
-METHODS	Patients were assessed by the visual analogue scale for anterior knee pain , the Knee Society clinical scoring system of knee score and function score , and patellar score for clinical function .
-METHODS	Patients ' satisfaction and lateral retinacular release-related complications were also evaluated .
-RESULTS	The overall incidence of anterior knee pain in the intervention group at 18 months follow-up was 5.6 % , while that of the control group was 20.6 % ( p = 0.009 ) .
-RESULTS	No statistical difference was detected between the two groups in terms of lateral retinacular release-related complications ( n.s. ) , patients ' satisfaction ( n.s. ) , knee score ( n.s. ) , function score ( n.s. ) , and patellar score ( n.s. ) at 18 months follow-up .
-CONCLUSIONS	The present study suggests that routine lateral retinacular release can reduce anterior knee pain and does not increase lateral retinacular release-related complications , in TKA with the use of the Gemini MK II mobile bearing without patellar resurfacing .
-METHODS	Therapeutic , Level I.
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-###25192478
-OBJECTIVE	This study was undertaken to investigate whether a gradual reduction of the valve setting ( opening pressure ) decreases the complication rate in patients with idiopathic normal-pressure hydrocephalus ( iNPH ) treated with a ventriculoperitoneal ( VP ) shunt .
-METHODS	In this prospective double-blinded , randomized , controlled , dual-center study , a VP shunt with an adjustable valve was implanted in 68 patients with iNPH , randomized into two groups .
-METHODS	In one group ( the 20-4 group ) the valve setting was initially set to 20 cm HO and gradually reduced to 4 cm H2O over the course of the 6-month study period .
-METHODS	In the other group ( the 12 group ) , the valve was kept at a medium pressure setting of 12 cm HO during the whole study period .
-METHODS	The time to and type of complications ( hematoma , infection , and mechanical problems ) as well as overdrainage symptoms were recorded .
-METHODS	Symptoms , signs , and outcome were assessed by means of the iNPH scale and the NPH grading scale .
-RESULTS	Six patients in the 20-4 group ( 22 % ) and 7 patients in the 12 group ( 23 % ) experienced a shunt complication ; 9 had subdural hematomas , 3 mechanical obstructions , and 1 infection ( no significant difference between groups ) .
-RESULTS	The frequency of overdrainage symptoms was significantly higher for a valve setting 12 cm HO compared with a setting > 12 cm HO .
-RESULTS	The 20-4 group had a higher improvement rate ( 88 % ) than the 12 group ( 62 % ) ( p = 0.032 ) .
-RESULTS	There was no significant relationship between complications and body mass index , the use of an antisiphon device , or the use of anticoagulants .
-CONCLUSIONS	Gradual lowering of the valve setting to a mean of 7 cm HO led to the same rate of shunt complications and overdrainage symptoms as a fixed valve setting at a mean of 13 cm HO but was associated with a significantly better outcome .
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-###25117173
-OBJECTIVE	The combination of direct-acting antiviral agents in patients with chronic hepatitis C virus ( HCV ) infection has demonstrated clinical benefit ; however , evaluation of potential drug-drug interactions is required prior to therapy .
-METHODS	An open-label study assessed the pharmacokinetics and tolerability of the HCV NS5A replication complex inhibitor daclatasvir and the HCV NS3 protease inhibitor asunaprevir when co-administered in healthy subjects .
-METHODS	Daclatasvir 60mg once daily and asunaprevir 600mg twice daily were dosed for 7days alone followed by combination dosing for 14days at 30mg once daily and 200mg twice daily , respectively .
-METHODS	Further assessments were provided comparing exposures from the current study with those from studies in HCV-infected patients receiving either the same or higher doses of daclatasvir or asunaprevir administered alone or together .
-RESULTS	Dose-normalized daclatasvir and asunaprevir morning exposures were comparable with control in healthy subjects , with geometric mean area under the concentration-time curve ratios of 1.202 ( 90 % CI 1.113-1 .298 ) and 0.868 ( 90 % CI 0.726-1 .038 ) , respectively .
-RESULTS	In HCV patients daclatasvir and asunaprevir exposures were largely comparable , when administered together or alone .
-CONCLUSIONS	Additional data support the conclusion that there is no clinically meaningful interaction between daclatasvir and asunaprevir in either healthy subjects or HCV-infected patients , including those also receiving peginterferon - / ribavirin , and that the combination of daclatasvir 60mg once daily and asunaprevir 200mg twice daily is generally well-tolerated .
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-###24408900
-BACKGROUND	Simplified informed consent forms have been successful in improving patient satisfaction and decreasing patient anxiety .
-BACKGROUND	However , unsolved problems remain about whether these documents improve comprehension and satisfaction of patients with standard literacy skills .
-OBJECTIVE	s To investigate whether a detailed consent form explaining the key elements of informed consent , in comparison to a standard consent form , would increase the comprehension and satisfaction of adult cancer patients .
-METHODS	Patients who were eligible for the National Surgical Adjuvant Study of Breast Cancer ( protocol 01 ( N-SAS/BC -01 ) ) were randomly selected to receive one of the following four versions : detailed document with graphics , detailed document without graphics , standard document with graphics , and standard document without graphics .
-METHODS	The forms were written in plain language from the patients ' point of view .
-METHODS	A total of 85 patients were administered questionnaires via interview to assess levels of comprehension , satisfaction , and anxiety .
-RESULTS	Patients demonstrated a strong understanding of information regarding treatment and research .
-RESULTS	Patient comprehension did not differ significantly between the detailed document arms and the standard document arms .
-RESULTS	Patient satisfaction level increased according to the amount of information presented in the consent form ; most patients preferred the detailed document with graphics .
-RESULTS	Anxiety and accrual rates in the parent study were not affected by informed consent procedures .
-CONCLUSIONS	Findings were limited to adults who had standard literacy skills and may not be generalizable to a population with lower literacy .
-CONCLUSIONS	Informed consent can be a significant experience for a population with standard literacy skills , as long as the document is easily comprehensible .
-CONCLUSIONS	Such information should be provided in a format that corresponds with patient needs , education levels , and preferences .
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-###24885811
-BACKGROUND	Providing additional Saturday rehabilitation can improve functional independence and health related quality of life at discharge and it may reduce patient length of stay , yet the economic implications are not known .
-BACKGROUND	The aim of this study was to determine from a health service perspective if the provision of rehabilitation to inpatients on a Saturday in addition to Monday to Friday was cost effective compared to Monday to Friday rehabilitation alone .
-METHODS	Cost utility and cost effectiveness analyses were undertaken alongside a multi-center , single-blind randomized controlled trial with a 30-day follow up after discharge .
-METHODS	Participants were adults admitted for inpatient rehabilitation in two publicly funded metropolitan rehabilitation facilities .
-METHODS	The control group received usual care rehabilitation services from Monday to Friday and the intervention group received usual care plus an additional rehabilitation service on Saturday .
-METHODS	Incremental cost utility ratio was reported as cost per quality adjusted life year ( QALY ) gained and an incremental cost effectiveness ratio ( ICER ) was reported as cost for a minimal clinically important difference ( MCID ) in functional independence .
-RESULTS	996 patients ( mean age 74 ( standard deviation 13 ) years ) were randomly assigned to the intervention ( n = 496 ) or the control group ( n = 500 ) .
-RESULTS	Mean difference in cost of AUD$ 1,673 ( 95 % confidence interval ( CI ) -271 to 3,618 ) was a saving in favor of the intervention group .
-RESULTS	The incremental cost utility ratio found a saving of AUD$ 41,825 ( 95 % CI -2,817 to 74,620 ) per QALY gained for the intervention group .
-RESULTS	The ICER found a saving of AUD$ 16,003 ( 95 % CI -3,074 to 87,361 ) in achieving a MCID in functional independence for the intervention group .
-RESULTS	If the willingness to pay per QALY gained or for a MCID in functional independence was zero dollars the probability of the intervention being cost effective was 96 % and 95 % , respectively .
-RESULTS	A sensitivity analysis removing Saturday penalty rates did not significantly alter the outcome .
-CONCLUSIONS	From a health service perspective , the provision of rehabilitation to inpatients on a Saturday in addition to Monday to Friday , compared to Monday to Friday rehabilitation alone , is likely to be cost saving per QALY gained and for a MCID in functional independence .
-BACKGROUND	Australian and New Zealand Clinical Trials Registry November 2009 ACTRN12609000973213 .
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-###24671453
-BACKGROUND	The maximal effect of proton pump inhibitors ( PPI ) is reported to take 5 days .
-BACKGROUND	However , most current protocols start PPI on the day of gastric endoscopic submucosal dissection ( ESD ) .
-OBJECTIVE	We aimed to evaluate the benefit of 5 days pretreatment with oral PPI before ESD to prevent bleeding .
-METHODS	This was a prospective randomized controlled trial .
-METHODS	Patients were administered oral rabeprazole 20 mg or placebo twice daily for 5 days before ESD .
-METHODS	Intravenous pantoprazole 40 mg was administered 2 h before ESD and at postprocedure day 1 , and then oral rabeprazole 20 mg was administered once daily .
-METHODS	Follow-up endoscopy was performed on days 1 and 30 .
-METHODS	Forty-eight-hour measurement of intragastric pH was performed in 26 patients .
-METHODS	The primary endpoint was major bleeding related to ESD .
-RESULTS	One-hundred and twenty patients were enrolled .
-RESULTS	Of these , 45 in the pretreatment and 53 in the placebo group were analyzed .
-RESULTS	Each group had three cases of major bleeding .
-RESULTS	There were no significant differences in the ulcer healing rate .
-RESULTS	Intragastric pH percentage times greater than 4 , 5 , and 6 were 86.61 19.45 % , 83.30 22.06 % , and 76.86 25.35 % , respectively , in the pretreatment and 85.54 19.45 % , 84.08 27.11 % , and 81.53 27.81 % , respectively , in the placebo group , without significant differences .
-CONCLUSIONS	Preprocedural administration of rabeprazole offers no additional benefit over postprocedural administration alone in preventing major bleeding after gastric ESD .
-
-###24761794
-BACKGROUND	To determine the relationship between type three secretion genotype and fluoroquinolone resistance for P. aeruginosa strains isolated from microbial keratitis during the Steroids for Corneal Ulcers Trial ( SCUT ) and for two laboratory strains , PA103 and PAO1 .
-METHODS	Confirmed P. aeruginosa isolates from the SCUT were divided into exoU ( + ) or exoU ( - ) .
-METHODS	The exoU ( + ) strains contained the gene encoding ExoU , a powerful phospholipase toxin delivered into host cells by the type three secretion system .
-METHODS	Isolates were then assessed for susceptibility to fluoroquinolone , cephalosporin , and aminoglycoside antibiotics using disk diffusion assays .
-METHODS	Etest was used to determine the MIC of moxifloxacin and other fluoroquinolones .
-METHODS	Laboratory isolates in which the exoU gene was added or deleted were also tested .
-RESULTS	A significantly higher proportion of exoU ( + ) strains were resistant to ciprofloxacin ( p = 0.001 ) , gatifloxacin ( p = 0.003 ) , and ofloxacin ( p = 0.002 ) compared to exoU ( - ) isolates .
-RESULTS	There was no significant difference between exoU ( + ) or exoU ( - ) negative isolates with respect to susceptibility to other antibiotics except gentamicin .
-RESULTS	Infections involving resistant exoU ( + ) strains trended towards worse clinical outcome .
-RESULTS	Deletion or acquisition of exoU in laboratory isolates did not affect fluoroquinolone susceptibility .
-CONCLUSIONS	Fluoroquinolone susceptibility of P. aeruginosa isolated from the SCUT is consistent with previous studies showing elevated resistance involving exoU encoding ( cytotoxic ) strains , and suggest worse clinical outcome from infections involving resistant isolates .
-CONCLUSIONS	Determination of exoU expression in clinical isolates of P. aeruginosa may be helpful in directing clinical management of patients with microbial keratitis .
-
-###25535265
-OBJECTIVE	Few evidence-based interventions address adolescent relationship abuse in clinical settings .
-OBJECTIVE	This cluster randomized controlled trial tested the effectiveness of a brief relationship abuse education and counseling intervention in school health centers ( SHCs ) .
-METHODS	In 2012-2013 , 11 SHCs ( 10 clusters ) were randomized to intervention ( SHC providers received training to implement ) or standard-of-care control condition .
-METHODS	Among 1062 eligible students ages 14 to 19 years at 8 SHCs who continued participation after randomization , 1011 completed computer-assisted surveys before a clinic visit ; 939 completed surveys 3 months later ( 93 % retention ) .
-RESULTS	Intervention versus control adjusted mean differences ( 95 % confidence interval ) on changes in primary outcomes were not statistically significant : recognition of abuse = 0.10 ( -0.02 to 0.22 ) ; intentions to intervene = 0.03 ( -0.09 to 0.15 ) ; and knowledge of resources = 0.18 ( -0.06 to 0.42 ) .
-RESULTS	Intervention participants had improved recognition of sexual coercion compared with controls ( adjusted mean difference = 0.10 [ 0.01 to 0.18 ] ) .
-RESULTS	In exploratory analyses adjusting for intensity of intervention uptake , intervention effects were significant for increased knowledge of relationship abuse resources and self-efficacy to use harm reduction behaviors .
-RESULTS	Among participants reporting relationship abuse at baseline , intervention participants were less likely to report such abuse at follow-up ( mean risk difference = -0.17 [ -0.21 to -0.12 ] ) .
-RESULTS	Adolescents in intervention clinics who reported ever being in an unhealthy relationship were more likely to report disclosing this during the SHC visit ( adjusted odds ratio = 2.77 [ 1.29 to 5.95 ] ) .
-CONCLUSIONS	This is the first evidence of the potential benefit of a SHC intervention to address abusive relationships among adolescents .
-
-###25467040
-OBJECTIVE	To assess bacterial colonization following balloon uterine stent placement in the uterus for 30 days .
-METHODS	Prospective randomized controlled study .
-METHODS	Tertiary medical center .
-METHODS	Sixty-eight women scheduled for hysteroscopy .
-METHODS	Women who were undergoing hysteroscopic surgery were randomly assigned to receive a balloon uterine stent or not .
-METHODS	Before starting surgery , the uterine cavity was swabbed for bacterial culture .
-METHODS	The device was placed in the uterus after surgery in the stent group .
-METHODS	After 30 days , the stent was removed and sent for culture and the uterine cavity also swabbed and cultured .
-METHODS	The uterine cavities of the control patients were swabbed before and 30 days after surgery .
-METHODS	The primary outcome was the incidence of bacterial colonization of the uterus .
-METHODS	Secondary outcomes were pain intensity and species of colonizing bacteria .
-RESULTS	Excluding eight women , 30 women in each group were included in this analysis .
-RESULTS	In the stent group , three women ( 10.0 % ) demonstrated bacterial colonization before surgery compared with nine women ( 30.0 % ) after 30 days .
-RESULTS	In the control group , four ( 13.3 % ) and ten ( 33.3 % ) women had microorganisms detected in the uterus before and after 30 days after surgery , respectively .
-RESULTS	In neither group did the percentage of women with uterine microorganisms increase significantly after 30 days .
-RESULTS	The percentages of women with uterine bacterial colonization before and 30 days after surgery were similar between both groups .
-CONCLUSIONS	Balloon uterine stents may be placed after surgery for up to 30 days without increasing bacterial colonization .
-BACKGROUND	ClinicalTrials.gov ( www.clinicaltrials.gov ) NCT01167296 .
-
-###24582914
-BACKGROUND	RAS mutations predict resistance to anti-epidermal growthfactor receptor ( EGFR ) monoclonal antibodies in metastatic colorectal cancer .
-BACKGROUND	We analysed RAS mutations in 30 non-metastatic rectal cancer patients treated with or without cetuximab within the 31 EXPERT-C trial .
-METHODS	Ninety of 149 patients with tumours available for analysis were KRAS/BRAF wild-type , and randomly assigned to capecitabine plus oxaliplatin ( CAPOX ) followed by chemoradiotherapy , surgery and adjuvant CAPOX or the same regimen plus cetuximab ( CAPOX-C ) .
-METHODS	Of these , four had a mutation of NRAS exon 3 , and 84 were retrospectively analysed for additional KRAS ( exon 4 ) and NRAS ( exons 2/4 ) mutations by using bi-directional Sanger sequencing .
-METHODS	The effect of cetuximab on study end-points in the RAS wild-type population was analysed .
-RESULTS	Eleven ( 13 % ) of 84 patients initially classified as KRAS/BRAF wild-type were found to have a mutation in KRAS exon 4 ( 11 % ) or NRAS exons 2/4 ( 2 % ) .
-RESULTS	Overall , 78/149 ( 52 % ) assessable patients were RAS wild-type ( CAPOX , n = 40 ; CAPOX-C , n = 38 ) .
-RESULTS	In this population , after a median follow-up of 63.8 months , in line with the initial analysis , the addition of cetuximab was associated with numerically higher , but not statistically significant , rates of complete response ( 15.8 % versus 7.5 % , p = 0.31 ) , 5-year progression-free survival ( 75.5 % versus 67.5 % , hazard ratio ( HR ) 0.61 , p = 0.25 ) and 5-year overall survival ( 83.8 % versus 70 % , HR 0.54 , p = 0.20 ) .
-CONCLUSIONS	RAS mutations beyond KRAS exon 2 and 3 were identified in 17 % of locally advanced rectal cancer patients .
-CONCLUSIONS	Given the small sample size , no definitive conclusions on the effect of additional RAS mutations on cetuximab treatment in this setting can be drawn and further investigation of RAS in larger studies is warranted .
-
-###25544167
-OBJECTIVE	To observe the therapeutic effect of extracorporeal shock wave combined with orthopaedic insole on plantar fasciitis .
-METHODS	A total of 153 plantar with plantar fasciitis were randomly divided into a combined group ( n = 51 ) , an extracorporeal shock wave group ( n = 53 ) and an orthopaedic group ( n = 49 ) .
-METHODS	The combined group received treatment of both extracorporeal shock wave and orthopaedic insole while the extracorporeal shock wave or the orthopaedic group only received the treatment of extracorporeal shock wave or orthopaedic insole .
-METHODS	The therapeutic parameters such as visual analogue scale ( VAS ) scores , continued walking time and thickness of the plantar fascia were monitored before and aft er the treatment for 2 weeks , 1 month and 3 months , respectively .
-RESULTS	The VAS scores in the 3 groups were all reduced after the treatment compared with the corresponding scores before the therapy ( P < 0.05 ) .
-RESULTS	The VAS score in the extracorporeal shock wave group was greater than that in the orthopedic group after the treatment for 2 weeks .
-RESULTS	The VAS score in the combined group was smaller than that in the orthopedic group after the treatment for 2 weeks and 3 months ( P < 0.05 ) .
-RESULTS	The VAS scores in the orthopedic group and the combined group were smaller than those in the extracorporeal shock wave group after the treatment for 1 month or 3 months ( P < 0.05 ) .
-RESULTS	The continued walking time and thickness of the plantar fascia was improved after the treatment ( P < 0.05 ) .
-RESULTS	The cure rate and total effective rate in the combination group were obviously greater than those in the two other groups .
-RESULTS	The cure rate in the orthopedic group was greater than that in the extracorporeal shock wave group ( P < 0.05 ) .
-CONCLUSIONS	Extracorporeal shock wave combined with orthopaedic insole therapy is an effective method to treat plantar fasciitis .
-CONCLUSIONS	It is recommended to spread in clinic .
-
-###24817030
-OBJECTIVE	The efficacy of noninvasive continuous positive airway pressure ( CPAP ) to improve outcomes in severe hypoxemic acute respiratory failure ( hARF ) due to pneumonia has not been clearly established .
-OBJECTIVE	The aim of this study was to compare CPAP vs. oxygen therapy to reduce the risk of meeting criteria for endotracheal intubation ( ETI ) .
-METHODS	In a multicenter randomized controlled trial conducted in four Italian centers patients with severe hARF due to pneumonia were randomized to receive helmet CPAP ( CPAP group ) or oxygen delivered with a Venturi mask ( control group ) .
-METHODS	The primary endpoint was the percentage of patients meeting criteria for ETI , including either one or more major criteria ( respiratory arrest , respiratory pauses with unconsciousness , severe hemodynamic instability , intolerance ) or at least two minor criteria ( reduction of at least 30 % of basal PaO2/FiO2 ratio , increase of 20 % of PaCO2 , worsening of alertness , respiratory distress , SpO2 less than 90 % , exhaustion ) .
-RESULTS	Between February 2010 and 2013 , 40 patients were randomized to CPAP and 41 to Venturi mask .
-RESULTS	The proportion of patients meeting ETI criteria in the CPAP group was significantly lower compared to those in the control group ( 6/40 = 15 % vs. 26/41 = 63 % , respectively , p < 0.001 ; relative risk 0.24 , 95 % CI 0.11-0 .51 ; number needed to treat , 2 ) two patients were intubated in the CPAP group and one in the control group .
-RESULTS	The CPAP group showed a faster and greater improvement in oxygenation in comparison to controls ( p < 0.001 ) .
-RESULTS	In either study group , no relevant adverse events were detected .
-CONCLUSIONS	Helmet CPAP reduces the risk of meeting ETI criteria compared to oxygen therapy in patients with severe hARF due to pneumonia .
-
-###24280811
-BACKGROUND	This randomized double-blind study was designed to compare palonosetron with palonosetron-dexamethasone combination for prevention of post operative nausea and vomiting ( PONV ) in patients undergoing laparoscopic cholecystectomy .
-METHODS	Eighty-four adult ASA 1-2 patients were randomly allocated into two groups .
-METHODS	Group P patients received 0.075 mg palonosetron and group PD patients received 0.075 mg palonosetron and 8 mg dexamethasone intravenously before induction of anesthesia .
-METHODS	Anesthesia was induced with propofol and fentanyl and maintained with N2O-isoflurane in oxygen .
-METHODS	All patients received port-site infiltration with bupivacaine and intravenous diclofenac for postoperative analgesia .
-METHODS	Metoclopramide was used as rescue antiemetic .
-METHODS	Patients were observed for the incidence of PONV and requirement of rescue antiemetic for 48 h after surgery .
-RESULTS	The complete response rate ( no vomiting ) was significantly higher in group DP as compared to group P between 0-24 h ( P = 0.004 ) .
-RESULTS	18 ( 42.9 % ) patients reported nausea and 14 ( 33.3 % ) patients had vomiting in group P while 6 ( 14.4 % ) patients had nausea and 5 ( 11.9 % ) patients complained of vomiting in group DP during 0-24 h. Two patients in group P reported nausea while none in group PD during 24-48 h. No patient had vomiting in either of the groups between 24-48 h.
-RESULTS	The requirement of rescue antiemetic was also less in group DP as compared to group P. Patients in group DP required less postoperative analgesia and were more satisfied with PONV treatment than group P patients .
-CONCLUSIONS	The palonosetron-dexamethasone combination was more effective as compared to only palonosetron for reducing PONV after laparoscopic cholecystectomy .
-
-###24241327
-OBJECTIVE	A large number of unrepaired inguinal hernias is expected in sub-Saharan Africa where late presentation often results in incarceration , strangulation , or giant scrotal hernias .
-OBJECTIVE	However , no representative population-based data are available to quantify the prevalence of hernias .
-OBJECTIVE	We present data on groin masses in Sierra Leone to estimate prevalence , barriers to care , and associated disability .
-METHODS	A cluster randomized , cross-sectional household survey of 75 clusters of 25 households with 2 respondents each was designed to calculate the prevalence of and disability caused by groin hernias in Sierra Leone using a verbal head-to-toe examination .
-METHODS	Barriers to hernia repairs were assessed by asking participants the main reason for delay in surgical care .
-RESULTS	Information was obtained from 3,645 respondents in 1,843 households , of which 1,669 ( 46 % ) were male and included in the study .
-RESULTS	In total , 117 males or 7.01 % ( 95 % CI 5.64-8 .38 ) reported a soft or reducible swelling likely representing a hernia with four men having two masses .
-RESULTS	Of the 93.2 % who indicated the need for health care , only 22.2 % underwent a procedure , citing limited funds ( 59.0 % ) as the major barrier to care .
-RESULTS	On disability assessment , 20.2 % were not able to work secondary to the groin swelling .
-CONCLUSIONS	The results indicate groin masses represent a major burden for the male population in Sierra Leone .
-CONCLUSIONS	Improving access to surgical care for adult patients with hernias and early intervention for children will be vital to address the burden of disease and prevent complications or limitations of daily activity .
-
-###24386447
-BACKGROUND	Health IT can play a major role in improving patient safety .
-BACKGROUND	Computerized physician order entry with decision support can alert providers to potential prescribing errors .
-BACKGROUND	However , too many alerts can result in providers ignoring and overriding clinically important ones .
-OBJECTIVE	To evaluate the appropriateness of providers ' drug-drug interaction ( DDI ) alert overrides , the reasons why they chose to override these alerts , and what actions they took as a consequence of the alert .
-METHODS	A cross-sectional , observational study of DDI alerts generated over a three-year period between January 1st , 2009 , and December 31st , 2011 .
-METHODS	Primary care practices affiliated with two Harvard teaching hospitals .
-METHODS	The DDI alerts were screened to minimize the number of clinically unimportant warnings .
-METHODS	A total of 24,849 DDI alerts were generated in the study period , with 40 % accepted .
-METHODS	The top 62 providers with the highest override rate were identified and eight overrides randomly selected for each ( a total of 496 alert overrides for 438 patients , 3.3 % of the sample ) .
-RESULTS	Overall , 68.2 % ( 338/496 ) of the DDI alert overrides were considered appropriate .
-RESULTS	Among inappropriate overrides , the therapeutic combinations put patients at increased risk of several specific conditions including : serotonin syndrome ( 21.5 % , n = 34 ) , cardiotoxicity ( 16.5 % , n = 26 ) , or sharp falls in blood pressure or significant hypotension ( 28.5 % , n = 45 ) .
-RESULTS	A small number of drugs and DDIs accounted for a disproportionate share of alert overrides .
-RESULTS	Of the 121 appropriate alert overrides where the provider indicated they would `` monitor as recommended '' , a detailed chart review revealed that only 35.5 % ( n = 43 ) actually did .
-RESULTS	Providers sometimes reported that patients had already taken interacting medications together ( 15.7 % , n = 78 ) , despite no evidence to confirm this .
-CONCLUSIONS	We found that providers continue to override important and useful alerts that are likely to cause serious patient injuries , even when relatively few false positive alerts are displayed .
-
-###25312783
-OBJECTIVE	The treatment strategy for steroid-resistant nephrotic syndrome remains uncertain at present , especially in those with calcineurin inhibitor resistance or intolerance .
-OBJECTIVE	To date , few studies have been published using multiple combination therapy of immunosuppressive reagents for children with calcineurin inhibitor-resistant or - intolerant nephrotic syndrome .
-METHODS	Eighteen consecutive children with steroid - and tacrolimus ( TAC ) - resistant ( n = 10 ) or TAC-sensitive but frequent relapsing nephrotic syndrome ( n = 8 ) were randomly recruited in the present study .
-METHODS	All of them received further triple-combination therapy by cyclophosphamide ( CTX , n = 6 ) , mycophenolate mofetil ( MMF , n = 5 ) or leflunomide ( LEF , n = 7 ) .
-METHODS	Their clinical data were collected and efficacy of triple-combination therapy was evaluated .
-RESULTS	Compared with previous double-combination therapy of prednisone ( Pre ) and TAC , the short-term remission rate in all 18 patients was significantly improved after the triple-combination therapy , while the frequent relapse rate in the following 12months was also significantly decreased .
-RESULTS	Among three different subgroups with CTX , MMF or LEF therapy , no significant difference was found in short-term remission rate and the relapse rate within 1year follow up by Kaplan-Meier plot .
-CONCLUSIONS	Triple-combination therapy with Pre + TAC+CTX / MMF/LEF is effective for short-term response and 1year remission , without significant additional side-effects seen in children with steroid-resistant and tacrolimus-resistant or tacrolimus-sensitive but frequently relapsing nephrotic syndrome .
-CONCLUSIONS	Further study for evaluating long-term efficacy and safety of triple-combination therapy with Pre + TAC+CTX / MMF/LEF would be necessary for these patients .
-
-###24609848
-BACKGROUND	Biospecimen collection from diverse populations can advance cancer disparities research , but is currently underrepresented .
-METHODS	We partnered with a community-based clinic serving Cantonese-speaking Chinese Americans to develop and revise an educational seminar on biospecimen collection .
-METHODS	Through a randomized controlled trial ( n = 395 ) , the intervention seminar was compared with a control seminar ( cancer prevention ) on change in willingness to donate biospecimens .
-RESULTS	At baseline , many were willing to donate a biospecimen ( saliva , urine , hair , toenails , blood , unused cancerous tissue ) whether healthy or hypothetically had cancer .
-RESULTS	Also , many would donate because future generations would benefit , and few had concerns about donation .
-RESULTS	In logistic regression analyses , there was an intervention effect for willingness to donate : urine if had cancer [ OR , 2.2 ; 95 % confidence interval ( CI ) , 1.3-3 .7 ] , toenails if healthy ( OR , 2.1 ; 95 % CI , 1.4-3 .2 ) or had cancer ( OR , 2.3 ; 95 % CI , 2.0-2 .7 ) , hair if healthy ( OR , 1.8 ; 95 % CI , 1.3-2 .5 ) or had cancer ( OR , 2.8 ; 95 % CI , 1.9-4 .0 ) , and unused cancerous tissue ( OR , 1.8 ; 95 % CI , 1.2-2 .9 ) .
-RESULTS	There was also an intervention effect for donating because future generations would benefit ( OR , 2.0 ; 95 % CI , 1.4-3 .0 ) , and this attitude was a strong independent predictor for willingness to donate all biospecimens , whether healthy or had cancer ( OR , 2.9-4 .2 ) .
-CONCLUSIONS	Cantonese-speaking Chinese American participants of an educational seminar on biospecimen collection showed greater increases in willingness to donate biospecimens and donating for the benefit of future generations , than participants who attended a control seminar .
-CONCLUSIONS	Donating for the benefit of future generations is a theme that should be incorporated in messages that encourage biospecimen donation for Chinese Americans .
-
-###25684089
-OBJECTIVE	To perform a randomized trial to determine whether there is cardiovascular disease ( CVD ) risk reduction from a plant-based ( PB ) , no-added-fat diet and the American Heart Association ( AHA ) diet in children .
-METHODS	A 4-week ( April 20 , 2013 to May 18 , 2013 ) , prospective randomized trial was undertaken in a large , Midwestern hospital system 's predominantly middle class outpatient pediatric practices .
-METHODS	Thirty children ( 9-18 years of age ) parent pairs with a last recorded child body mass index > 95th percentile and child cholesterol > 169 mg/dL were randomized to PB or AHA with weekly 2-hour classes of nutrition education .
-RESULTS	Children on PB had 9 and children on AHA had 4 statistically significant ( P < .05 ) beneficial changes from baseline ( mean decreases ) : body mass index z-score ( PB ) ( -0.14 ) , systolic blood pressure ( PB ) ( -6.43 mm Hg ) , total cholesterol ( PB ) ( -22.5 mg/dL ) , low-density lipoprotein ( PB ) ( -13.14 mg/dL ) , high-sensitivity C-reactive protein ( PB ) ( -2.09 mg/L ) , insulin ( PB ) ( -5.42 uU/mL ) , myeloperoxidase ( PB/AHA ) ( -75.34 / 69.23 pmol/L ) , mid-arm circumference ( PB/AHA ) ( -2.02 / -1.55 cm ) , weight ( PB/AHA ) ( -3.05 / -1.14 kg ) , and waist circumference ( AHA ) ( -2.96 cm ) .
-RESULTS	Adults on PB and AHA had 7 and 2 , respectively , statistically significant ( P < .05 ) beneficial changes .
-RESULTS	The significant change favoring AHA was a 1 % difference in children 's waist circumference .
-RESULTS	Difficulty shopping for food for the PB was the only statistically significant acceptability barrier .
-CONCLUSIONS	PB and the AHA in both children and adults demonstrated potentially beneficial changes from baseline in risk factors for CVD .
-CONCLUSIONS	Future larger , long-term randomized trials with easily accessible PB foods will further define the role of the PB in preventing CVD .
-
-###25863562
-BACKGROUND	Vitamin D has immunomodulatory effects that might aid clearance of mycobacterial infection .
-BACKGROUND	We aimed to assess whether vitamin D supplementation would reduce time to sputum culture conversion in patients with active tuberculosis .
-METHODS	We did this randomised , double-blind , placebo-controlled , superiority trial at 13 sites in India .
-METHODS	Treatment-naive patients who were sputum-smear positive , HIV negative , and had pulmonary tuberculosis were randomly assigned ( 1:1 ) , with centrally labelled , serially numbered bottles , to receive standard active tuberculosis treatment with either supplemental high-dose oral vitamin D3 ( four doses of 25 mg at weeks 0 , 2 , 4 , and 6 ) or placebo .
-METHODS	Neither the patients nor the clinical and laboratory investigators and personnel were aware of treatment assignment .
-METHODS	The primary efficacy outcome was time to sputum culture conversion .
-METHODS	Analysis was by modified intention to treat .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT00366470 .
-RESULTS	Between Jan 20 , 2010 , and Aug 23 , 2011 , we randomly assigned 247 participants to the vitamin D group ( n = 121 ) or the placebo group ( n = 126 ) , of whom 211 participants ( n = 101 and n = 110 , respectively ) were included in the primary efficacy analysis .
-RESULTS	Median time to culture conversion in the vitamin D group was 430 days ( 95 % CI 333-528 ) versus 420 days ( 339-501 ) in the placebo group ( log-rank p = 095 ) .
-RESULTS	Three ( 2 % ) patients died in the vitamin D group and one ( 1 % ) patient died in the placebo group ; no death was considered attributable to the study intervention .
-RESULTS	No patients had hypercalcaemia .
-CONCLUSIONS	Our findings show that vitamin D supplementation did not reduce time to sputum culture conversion .
-CONCLUSIONS	Further studies should investigate the role of vitamin D in prevention or reactivation of tuberculosis infection .
-BACKGROUND	Dalhousie University and Infectious Diseases Training and Research Centre .
-
-###25135743
-BACKGROUND	To further assess the safety profile of the fixed-dose combination of indacaterol and glycopyrronium ( QVA149 ) and its monocomponents ; we investigated the impact of individual patient-level factors and time by integrating the patient-level safety data from the QVA149 clinical programme with relevant information from the independent indacaterol and glycopyrronium safety databases .
-METHODS	Data from 11,404 patients with chronic obstructive pulmonary disease ( COPD ) were pooled from 14 clinical studies of QVA149 , indacaterol and glycopyrronium of 3 month 's duration with at least two of the treatment groups : QVA149 110/50g , glycopyrronium 50g , indacaterol 150g , placebo or tiotropium 18g .
-METHODS	Overall hazard ratio ( HR ) was assessed between the active treatments and placebo and in various subgroups related to severity of airways obstruction , inhaled corticosteroid use , cardiovascular risk factors , sex , age and body mass index for death , serious cases of cardio - and cerebrovascular ( CCV ) events , major adverse cardiovascular events ( MACEs ) , pneumonia , COPD exacerbations requiring hospitalisation or atrial flutter/fibrillation ( AF/F ) .
-RESULTS	The HR for QVA149 versus placebo showed no significant increase in the overall risk for death ( HR [ 95 % confidence interval ] : 0.93 [ 0.34-2 .54 ] ) ; CCV events ( 0.60 [ 0.29-1 .24 ] ) ; MACE ( 1.04 [ 0.45-2 .42 ] ) ; pneumonia ( 1.10 [ 0.54-2 .25 ] ) ; COPD exacerbations ( 0.60 [ 0.40-0 .91 ] ) ; and AF/F ( 1.03 [ 0.49-2 .18 ] ) .
-RESULTS	Similar results were observed for indacaterol , glycopyrronium and tiotropium versus placebo for overall risk and in analysed subgroups .
-CONCLUSIONS	There was no increase in the risk for the investigated safety endpoints for the fixed-dose combination QVA149 , and it had a comparable safety profile as its monocomponents and tiotropium versus placebo .
-
-###25444352
-OBJECTIVE	To evaluate safety and effectiveness of the TECNIS toric intraocular lenses ( IOLs ) .
-METHODS	Prospective , multicenter , 2-armed , bilateral , 6-month clinical trial following the American National Standards Institute ( ANSI ) standard for Toric IOLs .
-METHODS	Subjects implanted with a TECNIS toric IOL ( n = 172 ) or a TECNIS 1-piece control IOL ( ZCB00 ; n = 93 ) .
-METHODS	Subjects underwent standard cataract surgery with IOL implantation .
-METHODS	The randomized control arm consisted of subjects requiring cylinder correction of 0.75 to 1.50 diopters ( D ) who were implanted with either toric ( ZCT150 ) or nontoric ( ZCB00 ) IOLs .
-METHODS	The open-label arm ( OLA ) consisted of subjects requiring cylinder correction of 1.50 to 3.62 D and implanted with ZCT225 , ZCT300 , or ZCT400 IOLs .
-METHODS	Assessments were at 1 day , 1 week , and 1 , 3 , and 6 months and included uncorrected distance visual acuity ( UCDVA ) and best-corrected distance visual acuity ( BCDVA ) , manifest refraction , keratometry , adverse events , spectacle use , and photographic documentation of IOL rotational stability .
-RESULTS	Mean percent reduction in cylinder ( standard deviation ) was statistically significantly greater ( P < 0.0001 ) for ZCT150 eyes ( 74.53 72.25 % ) versus ZCB00 eyes ( 31.61 78.73 % ) .
-RESULTS	In the OLA , mean percent reduction in cylinder was 76.27 33.09 % .
-RESULTS	A UCDVA of 20/20 or better was achieved by 43.6 % ( 44/101 ) of ZCT150 eyes and by 23.7 % ( 22/93 ) of ZCB00 eyes ( P = 0.0026 ) .
-RESULTS	In the OLA , 38.0 % ( 27/71 ) achieved 20/20 or better UCDVA .
-RESULTS	Mean UCDVA was 0.10 0.14 for ZCT150 eyes and 0.16 0.16 for ZCB00 eyes ( P = 0.0009 ) ; in the OLA , mean UCDVA was 0.11 0.12 .
-RESULTS	The BCDVA was 20/40 or better for all eyes .
-RESULTS	Mean absolute lens rotation between visits for toric eyes pooled was less than 3 .
-RESULTS	Lens rotation of 5 or less occurred in 92.9 % of toric eyes between 1 and 3 months and in 94.1 % between 3 and 6 months , exceeding the ANSI standard for stability ( 90 % of eyes with 5 of rotation between visits ) .
-RESULTS	Four lenses ( 2.3 % ) were repositioned during the study .
-CONCLUSIONS	The TECNIS toric IOLs successfully reduce ocular astigmatism and are a safe and effective treatment for cataract patients with corneal astigmatism .
-
-###25299536
-OBJECTIVE	The purpose of this study was to determine whether whole-body vibration training could improve standing balance and muscle strength in children with Down syndrome .
-METHODS	This study was a randomized controlled trial studying 30 children ( 8-10 yrs old ) with Down syndrome .
-METHODS	They were assigned randomly using sealed envelopes , with 15 children allocated to the control group ( 9 boys , 6 girls ) and another 15 children allocated to the study group ( 8 boys , 7 girls ) .
-METHODS	The control group received a designed physical therapy program , whereas the study group received the same program given to the control group in addition to whole-body vibration training .
-METHODS	Both groups received the treatment sessions three times per week for 6 successive months .
-METHODS	Measurement of stability indices by using the Biodex Stability System as well as muscle strength of the knee flexors and extensors by using a handheld dynamometer was done before and after the 6 mos of the treatment program .
-RESULTS	Each group demonstrated significant improvements in stability indices and muscle strength after treatment ( P < 0.05 ) , with significantly greater improvements seen in the study group when compared with the control group ( P < 0.05 ) .
-CONCLUSIONS	Whole-body vibration may be a useful intervention modality to improve balance and muscle strength in children with Down syndrome .
-
-###25707624
-BACKGROUND	TAK-438 ( vonoprazan ) is a potassium-competitive acid blocker that reversibly inhibits gastric H ( + ) , K ( + ) - ATPase .
-OBJECTIVE	To evaluate the safety , tolerability , pharmacokinetics and pharmacodynamics of TAK-438 in healthy Japanese and non-Japanese men .
-METHODS	In two Phase I , randomised , double-blind , placebo-controlled studies , healthy men ( Japan N = 60 ; UK N = 48 ) received TAK-438 10-40mg once daily at a fixed dose level for 7 consecutive days .
-METHODS	Assessments included safety , tolerability , pharmacokinetics and pharmacodynamics ( intragastric pH ) .
-RESULTS	Plasma concentration-time profiles of TAK-438 at all dose levels showed rapid absorption ( median Tmax 2h ) .
-RESULTS	Mean elimination half-life was up to 9h .
-RESULTS	Exposure was slightly greater than dose proportional , with no apparent time-dependent inhibition of metabolism .
-RESULTS	There was no important difference between the two studies in AUC0-tau on Day 7 .
-RESULTS	TAK-438 caused dose-dependent acid suppression .
-RESULTS	On Day 7 , mean 24-h intragastric pH > 4 holding time ratio ( HTR ) with 40mg TAK-438 was 100 % ( Japan ) and 93.2 % ( UK ) , and mean night-time pH > 4 HTR was 100 % ( Japan ) and 90.4 % ( UK ) .
-RESULTS	TAK-438 was well tolerated .
-RESULTS	The frequency of adverse events was similar at all dose levels and there were no serious adverse events .
-RESULTS	There were no important increases in serum alanine transaminase activity .
-RESULTS	Serum gastrin and pepsinogen I and II concentrations increased with TAK-438 dose .
-CONCLUSIONS	TAK-438 in multiple rising oral dose levels of 10-40mg once daily for 7days was safe and well tolerated in healthy men and caused rapid , profound and sustained suppression of gastric acid secretion throughout each 24-h dosing interval .
-CONCLUSIONS	Clinicaltrials.gov identifiers : NCT02123953 and NCT02141711 .
-
-###24236828
-OBJECTIVE	PhaseIII DEFEND-2 investigated whether otelixizumab ( 3.1 mg over 8days ) preserved C-peptide secretion in patients with new-onset Type1 diabetes , focusing on adolescents ( 12-17years ) .
-METHODS	One hundred and seventy-nine patients ( 54 adolescents ) were randomized to otelixizumab or placebo .
-METHODS	The primary endpoint was change in 2-h mixed-meal-stimulated C-peptide area under the curve at month12 .
-METHODS	Enrolment was suspended in April 2011 following negative efficacy results from DEFEND-1 .
-METHODS	DEFEND-2 terminated early after 12months ' efficacy and safety follow-up .
-RESULTS	Change from baseline C-peptide was not significantly different [ = -0.09 nmol/l ( 95 % CI -0.17 to 0 ; P = 0.051 ) ] .
-RESULTS	No differential C-peptide effect was seen for otelixizumab in adolescents and more adverse events were reported .
-CONCLUSIONS	Efficacy and tolerability of otelixizumab was similar to DEFEND-1 .
-CONCLUSIONS	The 3.1-mg dose was non-efficacious in adults and adolescents .
-CONCLUSIONS	Further investigation of the mechanism of action seen at higher doses and therapeutic window is required .
-CONCLUSIONS	Clinical Trials Registry No : NCT00763451 .
-
-###25027170
-OBJECTIVE	Evaluation of the efficacy and toxicity of split-course accelerated hyperfractionated irradiation ( CHA-CHA ) as a sole treatment for advanced head and neck ( H&N ) cancer patients .
-METHODS	We enrolled 101 patients ( 39 in CHA-CHA and 37 in conventional ( Conv . )
-METHODS	arm completed the treatment ) .
-METHODS	The CHA-CHA arm patients were irradiated twice a day , 7 days a week , using a fraction dose ( fd ) of 1.6 Gy up to 64 Gy with an 8-day gap in midterm .
-METHODS	Patients in the control ( Conv . )
-METHODS	arm group were irradiated with a fd of 2 Gy , five times a week to a total dose of 72-74 Gy in the overall treatment time of 50-53 days .
-METHODS	Quality of life ( QOL ) and acute mucosal reaction were evaluated during radiotherapy ( RT ) .
-METHODS	After RT , we followed the effect of treatment , QOL , performance status and adverse effects of radiation .
-METHODS	For statistical analysis mainly a hierarchical multilevel modelling was used .
-RESULTS	QOL was most deteriorated in the CHA-CHA arm ; the CHA-CHA scheme also caused a relatively stronger acute injury .
-RESULTS	There were no significant differences in late adverse effects .
-RESULTS	In the CHA-CHA arm in 35 % and in Conv .
-RESULTS	arm in 30 % of patients , disease was controlled during follow-up .
-RESULTS	Tumour regression 1 year after the treatment was significantly better in the CHA-CHA arm .
-RESULTS	However , the overall survival rate analysis did not show significant difference between both arms .
-CONCLUSIONS	Despite differences in treatment results , we can not conclude that split-course accelerated hyperfractionated irradiation is superior to conventionally fractionated RT as a sole treatment for advanced H&N cancer patients .
-CONCLUSIONS	Obtained results in the context of published data support the statement that altered fractionations alone do not give an advantage for advanced H&N cancer patients .
-
-###25788234
-BACKGROUND	The Placement of Aortic Transcatheter Valves ( PARTNER ) trial showed that mortality at 1 year , 2 years , and 3 years is much the same with transcatheter aortic valve replacement ( TAVR ) or surgical aortic valve replacement ( SAVR ) for high-risk patients with aortic stenosis .
-BACKGROUND	We report here the 5-year outcomes .
-METHODS	We did this randomised controlled trial at 25 hospitals , in Canada ( two ) , Germany ( one ) , and the USA ( 23 ) .
-METHODS	We used a computer-generated randomisation sequence to randomly assign high-risk patients with severe aortic stenosis to either SAVR or TAVR with a balloon-expandable bovine pericardial tissue valve by either a transfemoral or transapical approach .
-METHODS	Patients and their treating physicians were not masked to treatment allocation .
-METHODS	The primary outcome of the trial was all-cause mortality in the intention-to-treat population at 1 year , we present here predefined outcomes at 5 years .
-METHODS	The study is registered with ClinicalTrials.gov , number NCT00530894 .
-RESULTS	We screened 3105 patients , of whom 699 were enrolled ( 348 assigned to TAVR , 351 assigned to SAVR ) .
-RESULTS	Overall mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 117 % .
-RESULTS	At 5 years , risk of death was 678 % in the TAVR group compared with 624 % in the SAVR group ( hazard ratio 104 , 95 % CI 086-124 ; p = 076 ) .
-RESULTS	We recorded no structural valve deterioration requiring surgical valve replacement in either group .
-RESULTS	Moderate or severe aortic regurgitation occurred in 40 ( 14 % ) of 280 patients in the TAVR group and two ( 1 % ) of 228 in the SAVR group ( p < 00001 ) , and was associated with increased 5-year risk of mortality in the TAVR group ( 724 % for moderate or severe aortic regurgitation vs 566 % for those with mild aortic regurgitation or less ; p = 0003 ) .
-CONCLUSIONS	Our findings show that TAVR as an alternative to surgery for patients with high surgical risk results in similar clinical outcomes .
-BACKGROUND	Edwards Lifesciences .
-
-###24444659
-BACKGROUND	Transthoracic echocardiographic ( TTE ) imaging is the mainstay of clinical practice for evaluating right ventricular ( RV ) size and function , but its accuracy in patients with pulmonary hypertension has not been well validated .
-METHODS	Magnetic resonance imaging ( MRI ) and TTE images were retrospectively reviewed in 40 consecutive patients with pulmonary hypertension .
-METHODS	RV and left ventricular volumes and ejection fractions were calculated using MRI .
-METHODS	TTE areas and indices of RV ejection fraction ( RVEF ) were compared .
-RESULTS	The average age was 42 12 years , with a majority of women ( 85 % ) .
-RESULTS	There was a wide range of mean pulmonary arterial pressures ( 27-81 mm Hg ) and RV end-diastolic volumes ( 111-576 mL ) , RVEFs ( 8 % -67 % ) , and left ventricular ejection fractions ( 26 % -72 % ) by MRI .
-RESULTS	There was a strong association between TTE and MRI-derived parameters : RV end-diastolic area ( by TTE imaging ) and RV end-diastolic volume ( by MRI ) , R ( 2 ) = 0.78 ( P < .001 ) ; RV fractional area change by TTE imaging and RVEF by MRI , R ( 2 ) = 0.76 ( P < .001 ) ; and tricuspid annular plane systolic excursion by TTE imaging and RVEF by MRI , R ( 2 ) = 0.64 ( P < .001 ) .
-RESULTS	By receiver operating characteristic curve analysis , an RV fractional area change < 25 % provided excellent discrimination of moderate systolic dysfunction ( RVEF < 35 % ) , with an area under the curve of 0.97 ( P < .001 ) .
-RESULTS	An RV end-diastolic area index of 18cm ( 2 ) / m ( 2 ) provided excellent discrimination for moderate RV enlargement ( area under the curve , 0.89 ; P < .001 ) .
-CONCLUSIONS	Echocardiographic estimates of RV volume ( by RV end-diastolic area ) and function ( by RV fractional area change and tricuspid annular plane systolic excursion ) offer good approximations of RV size and function in patients with pulmonary hypertension and allow the accurate discrimination of normal from abnormal .
-
-###24799543
-OBJECTIVE	Previous studies have focused on the effect of food advertisements on the caloric intake of children .
-OBJECTIVE	However , the role of individual susceptibility in this effect is unclear .
-OBJECTIVE	The aim of this study was to examine the role of impulsivity in the effect of advergames that promote energy-dense snacks on children 's snack intake .
-METHODS	First , impulsivity scores were assessed with a computer task .
-METHODS	Then a randomized between-subject design was conducted with 261 children aged 7 to 10 years who played an advergame promoting either energy-dense snacks or nonfood products .
-METHODS	As an extra manipulation , half of the children in each condition were rewarded for refraining from eating , the other half were not .
-METHODS	Children could eat freely while playing the game .
-METHODS	Food intake was measured .
-METHODS	The children then completed questionnaire measures , and were weighed and measured .
-RESULTS	Overall , playing an advergame containing food cues increased general caloric intake .
-RESULTS	Furthermore , rewarding children to refrain from eating decreased their caloric intake .
-RESULTS	Finally , rewarding impulsive children to refrain from eating had no influence when they were playing an advergame promoting energy-dense snacks , whereas it did lead to reduced intake among low impulsive children and children who played nonfood advergames .
-CONCLUSIONS	Playing an advergame promoting energy-dense snacks contributes to increased caloric intake in children .
-CONCLUSIONS	The advergame promoting energy-dense snacks overruled the inhibition task to refrain from eating among impulsive children , making it more difficult for them to refrain from eating .
-CONCLUSIONS	The findings suggest that impulsivity plays an important role in susceptibility to food advertisements .
-
-###25011722
-BACKGROUND	The EVEREST II ( Endovascular Valve Edge-to-Edge REpair STudy ) High-Risk registry and REALISM Continued Access Study High-Risk Arm are prospective registries of patients who received the MitraClip device ( Abbott Vascular , Santa Clara , California ) for mitral regurgitation ( MR ) in the United States .
-OBJECTIVE	The purpose of this study was to report 12-month outcomes in high-risk patients treated with the percutaneous mitral valve edge-to-edge repair .
-METHODS	Patients with grades 3 to 4 + MR and a surgical mortality risk of 12 % , based on the Society of Thoracic Surgeons risk calculator or the estimate of a surgeon coinvestigator following pre-specified protocol criteria , were enrolled .
-RESULTS	In the studies , 327 of 351 patients completed 12 months of follow-up .
-RESULTS	Patients were elderly ( 76 11 years of age ) , with 70 % having functional MR and 60 % having prior cardiac surgery .
-RESULTS	The mitral valve device reduced MR to 2 + in 86 % of patients at discharge ( n = 325 ; p < 0.0001 ) .
-RESULTS	Major adverse events at 30 days included death in 4.8 % , myocardial infarction in 1.1 % , and stroke in 2.6 % .
-RESULTS	At 12 months , MR was 2 + in 84 % of patients ( n = 225 ; p < 0.0001 ) .
-RESULTS	From baseline to 12 months , left ventricular ( LV ) end-diastolic volume improved from 161 56 ml to 143 53 ml ( n = 203 ; p < 0.0001 ) and LV end-systolic volume improved from 87 47 ml to 79 44 ml ( n = 202 ; p < 0.0001 ) .
-RESULTS	New York Heart Association functional class improved from 82 % in class III/IV at baseline to 83 % in class I/II at 12 months ( n = 234 ; p < 0.0001 ) .
-RESULTS	The 36-item Short Form Health Survey physical and mental quality-of-life scores improved from baseline to 12 months ( n = 191 ; p < 0.0001 ) .
-RESULTS	Annual hospitalization rate for heart failure fell from 0.79 % pre-procedure to 0.41 % post-procedure ( n = 338 ; p < 0.0001 ) .
-RESULTS	Kaplan-Meier survival estimate at 12 months was 77.2 % .
-CONCLUSIONS	The percutaneous mitral valve device significantly reduced MR , improved clinical symptoms , and decreased LV dimensions at 12 months in this high-surgical-risk cohort .
-CONCLUSIONS	( Endovascular Valve Edge-to-Edge REpair STudy [ EVERESTIIRCT ] ; NCT00209274 ) .
-
-###24828790
-OBJECTIVE	The aim of this study was to compare health-related quality of life ( HRQoL ) scores obtained from the instrument Short Form ( SF ) -36 through the so-called SF-6D utilities , and those obtained from 15D , in patients with ST-elevation myocardial infarction ( STEMI ) , and to evaluate the consequences in estimation of quality adjusted life years ( QALYs ) .
-METHODS	This was a sub-study of the Norwegian District Treatment of STEMI , in which patients with STEMI treated with tenecteplase , were randomized to early angioplasty or standard management ( n = 266 ) .
-METHODS	HRQoL data were collected at all visits ( 0 , 1 , 3 , 7 and 12 months ) .
-METHODS	All patients with complete data were included ( n = 248 ) .
-RESULTS	The score range was 0.33-1 .0 for SF-6D and 0.49-1 .0 for 15D .
-RESULTS	Mean utility scores from 15D were higher and had different distribution compared to scores from SF-6D .
-RESULTS	Mean QALY for the whole group was higher using 15D than SF-6D ( 0.89 vs. 0.77 ) .
-RESULTS	The incremental number of QALYs with early angioplasty compared to standard treatment was 0.005 ( 95 % CI : - 0.018 to 0.028 ) using SF-6D , and 0.004 ( 95 % CI : - 0.010 to 0.018 ) using the 15D instrument .
-CONCLUSIONS	Choice of instrument may influence HRQoL scores , but not necessarily the gain in QALYs .
-
-###24315521
-BACKGROUND	Post-thrombotic syndrome ( PTS ) is a common and burdensome complication of deep venous thrombosis ( DVT ) .
-BACKGROUND	Previous trials suggesting benefit of elastic compression stockings ( ECS ) to prevent PTS were small , single-centre studies without placebo control .
-BACKGROUND	We aimed to assess the efficacy of ECS , compared with placebo stockings , for the prevention of PTS .
-METHODS	We did a multicentre randomised placebo-controlled trial of active versus placebo ECS used for 2 years to prevent PTS after a first proximal DVT in centres in Canada and the USA .
-METHODS	Patients were randomly assigned to study groups with a web-based randomisation system .
-METHODS	Patients presenting with a first symptomatic , proximal DVT were potentially eligible to participate .
-METHODS	They were excluded if the use of compression stockings was contraindicated , they had an expected lifespan of less than 6 months , geographical inaccessibility precluded return for follow-up visits , they were unable to apply stockings , or they received thrombolytic therapy for the initial treatment of acute DVT .
-METHODS	The primary outcome was PTS diagnosed at 6 months or later using Ginsberg 's criteria ( leg pain and swelling of 1 month duration ) .
-METHODS	We used a modified intention to treat Cox regression analysis , supplemented by a prespecified per-protocol analysis of patients who reported frequent use of their allocated treatment .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT00143598 , and Current Controlled Trials , number ISRCTN71334751 .
-RESULTS	From 2004 to 2010 , 410 patients were randomly assigned to receive active ECS and 396 placebo ECS .
-RESULTS	The cumulative incidence of PTS was 142 % in active ECS versus 127 % in placebo ECS ( hazard ratio adjusted for centre 113 , 95 % CI 073-176 ; p = 058 ) .
-RESULTS	Results were similar in a prespecified per-protocol analysis of patients who reported frequent use of stockings .
-CONCLUSIONS	ECS did not prevent PTS after a first proximal DVT , hence our findings do not support routine wearing of ECS after DVT .
-BACKGROUND	Canadian Institutes of Health Research .
-
-###25082573
-BACKGROUND	The results of SYNTAX trial have been reported based on `` corelab '' calculated SS ( cSS ) .
-BACKGROUND	It has been shown that reproducibility of SS is better among the core laboratory technicians than interventional cardiologists .
-BACKGROUND	Thus , the prognostic value and clinical implication of the `` site '' SYNTAX SS ( sSS ) remain unknown .
-OBJECTIVE	The study sought to evaluate the prognostic value and clinical implication of the sSS after percutaneous coronary intervention ( PCI ) or coronary artery bypass graft ( CABG ) surgery in the randomized SYNTAX trial .
-METHODS	The sSS was calculated by the site investigators before randomization in the SYNTAX trial .
-METHODS	New tertiles based on the sSS were defined with low ( 0 to 19 ) , intermediate ( 20 to 27 ) , and high ( 28 ) scores .
-METHODS	The clinical endpoints were compared between PCI and CABG by Kaplan-Meier estimates , log-rank comparison , and Cox regression analyses using the new tertiles .
-METHODS	The sSS-based SS II was calculated and its predictive performance was evaluated .
-RESULTS	The mean difference in cSS and sSS is 3.8 11.2 , with a mean absolute difference of 8.9 7.8 .
-RESULTS	In the overall cohort , using sSS there was a higher incidence of major adverse cardiac and cerebrovascular events ( MACCE ) at 5-year follow-up in the PCI group for low ( 31.9 % vs. 24.5 % ; p = 0.054 ) , intermediate ( 39.5 % vs. 29.5 % ; p = 0.019 ) , and high ( 43.0 % vs. 31.4 % ; p = 0.003 ) tertiles , compared with the CABG group .
-RESULTS	Similarly , in the 3-vessel disease subgroup , 5-year MACCE rates were higher in PCI group in all tertiles .
-RESULTS	Conversely , in the left main subgroup , MACCE rates were similar for PCI and CABG groups in all tertiles .
-RESULTS	The sSS-based SS II ( c-index : 0.736 ) had predictive performance similar to the cSS-based SS II ( c-index : 0.744 ) , with net reclassification index of -0.0062 ( p = 0.79 ) .
-CONCLUSIONS	Appropriate training and unbiased assessment are needed when using SS in clinical decision making .
-CONCLUSIONS	sSS and tertiles based on sSS showed poor discrimination among low , intermediate , and high-risk groups .
-CONCLUSIONS	However , combining clinical factors with sSS retained the predictive performance of SS II .
-CONCLUSIONS	( SYNTAX Study : TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries ; NCT00114972 ) .
-
-###24429541
-BACKGROUND	Epidemiologic evidence has suggested that diets with a high ratio of palmitic acid ( PA ) to oleic acid ( OA ) increase risk of cardiovascular disease ( CVD ) .
-OBJECTIVE	To gain additional insights into the relative effect of dietary fatty acids and their metabolism on CVD risk , we sought to identify a metabolomic signature that tracks with diet-induced changes in blood lipid concentrations and whole-body fat oxidation .
-METHODS	We applied comprehensive metabolomic profiling tools to biological specimens collected from 18 healthy adults enrolled in a crossover trial that compared a 3-wk high-palmitic acid ( HPA ) with a low-palmitic acid and high-oleic acid ( HOA ) diet .
-RESULTS	A principal components analysis of the data set including 329 variables measured in 15 subjects in the fasted state identified one factor , the principal components analysis factor in the fasted state ( PCF1-Fasted ) , which was heavily weighted by the PA : OA ratio of serum and muscle lipids , that was affected by diet ( P < 0.0001 ; HPA greater than HOA ) .
-RESULTS	One other factor , the additional principal components analysis factor in the fasted state ( PCF2-Fasted ) , reflected a wide range of acylcarnitines and was affected by diet in women only ( P = 0.0198 ; HPA greater than HOA ) .
-RESULTS	HOA lowered the ratio of serum low-density lipoprotein to high-density lipoprotein ( LDL : HDL ) in men and women , and adjustment for the PCF1-Fasted abolished the effect .
-RESULTS	In women only , adjustment for the PCF2-Fasted eliminated the HOA-diet effect on serum total - and LDL-cholesterol concentrations .
-RESULTS	The respiratory exchange ratio in the fasted state was lower with the HPA diet ( P = 0.04 ) , and the diet effect was eliminated after adjustment for the PCF1-Fasted .
-RESULTS	The messenger RNA expression of the cholesterol regulatory gene insulin-induced gene-1 was higher with the HOA diet ( P = 0.008 ) .
-CONCLUSIONS	These results suggest that replacing dietary PA with OA reduces the blood LDL concentration and whole-body fat oxidation by modifying the saturation index of circulating and tissue lipids .
-CONCLUSIONS	In women , these effects are also associated with a higher production and accumulation of acylcarnitines , possibly reflecting a shift in fat catabolism .
-
-###24520784
-OBJECTIVE	To observe the effect of qi benefiting stasis removing method ( QBSRM ) on systemic inflammatory response and coagulation function in multiple organ dysfunction syndrome ( MODS ) patients .
-METHODS	Totally 40 MODS patients who were admitted to Affiliated Hospital of Nanjing University of Traditional Chinese Medicine between May 2010 to December 2011 were randomly assigned to two groups , the experimental group ( 21 cases ) and the control group ( 19 cases ) .
-METHODS	Patients in the control group were treated with routine Western therapy , while those in the experimental group additionally took decoction for benefiting qi removing stasis .
-METHODS	Inflammatory factors ( including interleukin-1 , interleukin-6 , tumor necrosis factor-alpha ) and coagulation parameters [ including prothrombin time ( PT ) , activated partial thromboplastin time ( APTT ) , fibrinogen ( FIB ) , and D-dimer ( DD ) ] were observed before treatment , and 3 , 7 , and 14 days after treatment in the two groups .
-RESULTS	At day 7 after treatment , levels of interleukin-1 , interleukin-6 , and PT were significantly lower in the experimental group than in the control group ( P < 0.05 ) .
-RESULTS	At day 14 after treatment , tumor necrosis factor-x and DD were significantly lower in the experimental group than in the control group ( P < 0.05 ) .
-RESULTS	There was no statistical difference in APTT or FIB at day 3 , 7 and 14 after treatment ( P > 0.05 ) .
-CONCLUSIONS	QBSRM could relieve systemic inflammatory response and improve coagulation functions .
-
-###24766978
-BACKGROUND	We previously found that the use of ezetimibe increased rapidly with different patterns between the United States ( US ) and Canada prior to the landmark Ezetimibe and Simvastatin in Hypercholesterolemia Enhance Atherosclerosis Regression ( ENHANCE ) trial , which was reported in January 2008 , and failed to show that the drug slowed the progression of atherosclerosis .
-BACKGROUND	What is not known is how practice in the 2 countries changed after the ENHANCE trial .
-BACKGROUND	We examined ezetimibe use trends in the US and Canada before and after the reporting of the ENHANCE trial .
-METHODS	We conducted a population-based , retrospective , time-series analysis using the data collected by IMS Health in the US and CompuScript in Canada from January 1 , 2002 , to December 31 , 2009 .
-METHODS	The main outcome measure was monthly number of prescriptions for ezetimibe-containing products .
-RESULTS	The monthly number of ezetimibe prescriptions/100 ,000 population rose from 6 to 1,082 in the US from November 2002 to January 2008 , then significantly declined to 572/100 ,000 population by December 2009 after the release of the ENHANCE trial , a decrease of 47.1 % ( P < .001 ) .
-RESULTS	In contrast , in Canada , use continuously rose from 2 to 495/100 ,000 population from June 2003 to December 2009 ( P = .2 ) .
-RESULTS	United States expenditures totaled $ 2.24 billion in 2009 .
-CONCLUSIONS	Ezetimibe remains commonly used in both the US and Canada .
-CONCLUSIONS	Ezetimibe use has decreased in the US post-ENHANCE , whereas use has gradually but steadily increased in Canada .
-CONCLUSIONS	The diverging patterns of ezetimibe use in the US and Canada require further investigation , as they reveal that a common evidence base is eliciting very different utilization patterns in neighboring countries .
-
-###25739317
-OBJECTIVE	To compare mean heart and left anterior descending coronary artery ( LAD ) doses ( NTDmean ) and positional reproducibility in larger-breasted women receiving left breast radiotherapy using supine voluntary deep-inspiratory breath-hold ( VBH ) and free-breathing prone techniques .
-METHODS	Following surgery for early breast cancer , patients with estimated breast volumes > 750 cm ( 3 ) underwent planning-CT scans in supine VBH and free-breathing prone positions .
-METHODS	Radiotherapy treatment plans were prepared , and mean heart and LAD doses were calculated .
-METHODS	Patients were randomised to receive one technique for fractions 1-7 , before switching techniques for fractions 8-15 ( 40 Gy/15 fractions total ) .
-METHODS	Daily electronic portal imaging and alternate-day cone-beam CT ( CBCT ) imaging were performed .
-METHODS	The primary endpoint was the difference in mean LAD NTDmean between techniques .
-METHODS	Population systematic ( ) and random errors ( ) were estimated .
-METHODS	Within-patient comparisons between techniques used Wilcoxon signed-rank tests .
-RESULTS	34 patients were recruited , with complete dosimetric data available for 28 .
-RESULTS	Mean heart and LAD NTDmean doses for VBH and prone treatments respectively were 0.4 and 0.7 ( p < 0.001 ) and 2.9 and 7.8 ( p < 0.001 ) .
-RESULTS	Clip-based CBCT errors for VBH and prone respectively were 3.0 mm and 6.5 mm ( ) and 3.5 mm and 5.4 mm ( ) .
-CONCLUSIONS	In larger-breasted women , supine VBH provided superior cardiac sparing and reproducibility than a free-breathing prone position .
-
-###25710923
-OBJECTIVE	Depression is common in diabetes and linked to adverse health outcomes .
-OBJECTIVE	This study evaluated the efficacy of a guided web-based intervention in reducing depression in adults with type 1 and type 2 diabetes .
-METHODS	A total of 260 participants with diabetes and elevated depressive symptoms ( Center for Epidemiologic Studies Depression Scale [ CES-D 23 ] ) were randomly assigned to the GET.ON Mood Enhancer Diabetes ( a guided self-help intervention , n = 130 ) or a brief online unguided psychoeducation program for depression ( n = 130 ) .
-METHODS	The primary outcome was depressive symptoms severity ( CES-D ) .
-METHODS	The secondary outcomes included diabetes-specific emotional distress ( Problem Areas in Diabetes [ PAID ] scale ) and participant satisfaction ( adaption CSQ-8 ) .
-METHODS	Data were collected at baseline and 2 months after randomization .
-METHODS	To identify differences in outcome between the groups , we used analyses of covariance with the baseline CES-D score as covariate on both intent-to-treat ( ITT ) and per-protocol ( PP ) basis .
-RESULTS	Compared with the control group , the intervention group showed significantly less depressive symptom severity at posttreatment based on ITT ( d = 0.89 ) and PP analyses ( d = 1.00 ) .
-RESULTS	The intervention participants displayed a significantly larger reduction in diabetes-specific emotional distress ( d = 0.58 , ITT ) .
-RESULTS	The intervention appeared to be acceptable to the participants ; 95 % ( n = 121 ) would recommend the training to a friend with diabetes in need of psychological help .
-CONCLUSIONS	A guided , web-based intervention to reduce depression in adults with type 1 and type 2 diabetes is effective in reducing both depressive symptoms and diabetes-specific emotional distress .
-
-###24284498
-BACKGROUND	Dietary sodium influences intermediate physiological traits in healthy adults independent of changes in blood pressure .
-BACKGROUND	The purpose of this study was to test the hypothesis that dietary sodium affects cardiac autonomic modulation during mental stress .
-METHODS	In a prospective , randomized cross-over design separated by 1 month between diets , 70 normotensive healthy young adults ( F/M : 44/26 , aged 18-38 years ) consumed a 5-day low ( 10 mmol/day ) , normal ( 150 mmol ) , and high ( 400 mmol ) sodium diet followed by heart rate variability ( HRV ) recordings at rest and during 5-min computerized mental arithmetic .
-METHODS	Women were studied in the low hormone phase of the menstrual cycle following each diet .
-RESULTS	Diet did not affect resting blood pressure , but heart rate ( HR ) ( mean SE ) was 66 1 , 64 1 , and 63 1 bpm in low , normal , and high sodium conditions , respectively ( analysis of variance P = 0.02 ) .
-RESULTS	For HRV , there was a main effect of sodium on resting SD of normalized RR intervals ( SDNN ) , square root of the mean squared difference of successive normalized RR intervals ( RMSSD ) , high frequency , low-frequency normalized units ( LFnu ) , and high-frequency normalized units ( HFnu ) ( P < 0.01 for all ) .
-RESULTS	The response to low sodium was most marked and consistent with sympathetic activation and reduced vagal activity , with increased LFnu and decreased SDNN , RMSSD , and HFnu compared to both normal and high sodium conditions ( P 0.05 for all ) .
-RESULTS	Dietary sodium-by-mental stress interactions were significant for mean NN , RMSSD , high-frequency power , LFnu , and low frequency/high frequency ratio ( P < 0.05 for all ) .
-RESULTS	The interactions signify that sodium restriction evoked an increase in resting sympathetic activity and reduced vagal activity to the extent that mental stress caused modest additional disruptions in autonomic balance .
-RESULTS	Conversely , normal and high sodium evoked a reduction in resting sympathetic activity and incremental increase in resting vagal activity , which were disrupted to a greater extent during mental stress compared to low sodium .
-CONCLUSIONS	We conclude that autonomic control of HRV at rest and during mental stress is altered by dietary sodium in healthy normotensive young adult men and women .
-
-###24942975
-BACKGROUND	Beta-palmitate ( sn-2 palmitate ) mimics human milk fat , enabling easier digestion.Therefore , we hypothesized that infants consuming high beta-palmitate formula would have more frequent , softer stools and reduced crying compared to infants consuming low beta-palmitate formula .
-METHODS	Formula-fed infants were randomly assigned to receive either ( 1 ) formula with high beta-palmitate ( HBP , n = 21 ) or ( 2 ) regular formula with a standard vegetable oil mix ( LBP , n = 21 ) .
-METHODS	A matched group of breastfed infants served as a reference ( BF , n = 21 ) .
-METHODS	Crying and stool characteristics data were recorded by the parents for 3 days before the 6 - and 12-week visits .
-RESULTS	We found no significant differences in the stool frequency or consistency between the two formula groups .
-RESULTS	The percentage of crying infants in the LBP group was significantly higher than that in the HBP and BF groups during the evening at 6 weeks ( 88.2 % vs. 56.3 % and 55.6 % , p < 0.05 ) and during the afternoon at 12 weeks ( 91.7 % vs. 50.0 % and 40 % , p < 0.05 ) .
-RESULTS	The infants fed HBP had significantly shorter crying durations when compared with infants fed LBP formula ( 14.90 3.85 vs. 63.96 21.76 min/day , respectively ; p = 0.047 ) .
-CONCLUSIONS	Our study indicates that consumption of a high beta-palmitate formula affects infant crying patterns during the first weeks of life .
-CONCLUSIONS	Comparable to breastfeeding , it reduced crying duration and frequency , primarily during the afternoon and evening hours , thereby improving the well-being of formula-fed infants and their parents .
-BACKGROUND	NCT00874068.Registration date March 31 , 2009 .
-
-###25358221
-BACKGROUND	Acne vulgaris is a common inflammatory disorder of the skin that involves pilosebaceous units .
-BACKGROUND	This study was conducted to compare the efficacy of oral azithromycin with oral doxycycline in the treatment of acne vulgaris in our population .
-METHODS	This randomized controlled trial was conducted in the dermatology department of Lady Reading Hospital , Peshawar from January to December 2011 .
-METHODS	All male and female patients of age ( 14-30 years ) having moderate acne vulgaris on face only were included in the study .
-METHODS	Patients were randomly divided into two groups .
-METHODS	Patients in first group were given azithromycin 500 mg daily before meal for 4 consecutive days monthly for 3 months while patients in second group were given doxycycline 100 mg daily after meals for 3 months .
-METHODS	Patients were followed up after taking treatment for three months to see the response of each drug .
-METHODS	Response was graded as excellent , good , moderate , mild and no response .
-RESULTS	A total of 386 patients equally divided in azithromycin and doxycycline groups .
-RESULTS	Male to female ratio in azithromycin and doxycycline groups was 0.82:1.11 and 0.89:1.04 respectively .
-RESULTS	Mean age in both groups was 18.45 2.91 years and 17.96 2.59 years respectively .
-RESULTS	In azithromycin group , an excellent response was noted in 6 ( 3.1 % ) , and good response was observed in 44 ( 22.8 % ) patients .
-RESULTS	In doxycycline group 22 ( 11.4 % ) patients had excellent and 107 ( 55.4 % ) patients had good response .
-RESULTS	The difference being statistically significant .
-CONCLUSIONS	Doxycycline is a better option fdr treatment of acne vulgaris as compared to azithromycin .
-
-###24415509
-OBJECTIVE	Residents often teach medical students , other residents , and patients .
-OBJECTIVE	However , few residents get feedback about their teaching .
-OBJECTIVE	This study 's objective was to determine if feedback from medical students increases resident teaching identity .
-METHODS	This was a stratified , single blinded , randomized controlled trial of an educational intervention .
-METHODS	Residents were stratified based on year of residency and then randomized to receive feedback by medical students or not .
-METHODS	Medical students evaluated resident teaching effectiveness by ranking resident ability to apply the five microskills for clinical teaching and to role model being an effective clinician .
-METHODS	Residents were surveyed to determine their level of teacher identity before and after the intervention .
-METHODS	Allocation concealment and intention to treat principles were used .
-RESULTS	All residents ( n = 32 ) that met inclusion criteria participated with complete response rate to both pre-intervention and post-intervention surveys .
-RESULTS	There was no difference in teaching identity between residents who received feedback and those who did not , except in one subscale of the Teacher Identity Scale-global teaching identity , where residents who received medical student feedback scored lower .
-CONCLUSIONS	There was no difference between intervention and control group in resident teaching identity over time .
-CONCLUSIONS	The residents found feedback important .
-CONCLUSIONS	This was a randomized controlled trial with strong methodology that helps advance understanding of the importance of medical student feedback on resident teaching .
-
-###24507091
-BACKGROUND	No available treatments slow or halt progression of multiple system atrophy , which is a rare , progressive , fatal neurological disorder .
-BACKGROUND	In a mouse model of multiple system atrophy , rifampicin inhibited formation of - synuclein fibrils , the neuropathological hallmark of the disease .
-BACKGROUND	We aimed to assess the safety and efficacy of rifampicin in patients with multiple system atrophy .
-METHODS	In this randomised , double-blind , placebo-controlled trial we recruited participants aged 30-80 years with possible or probable multiple system atrophy from ten US medical centres .
-METHODS	Eligible participants were randomly assigned ( 1:1 ) via computer-generated permuted block randomisation to rifampicin 300 mg twice daily or matching placebo ( 50 mg riboflavin capsules ) , stratified by subtype ( parkinsonian vs cerebellar ) , with a block size of four .
-METHODS	The primary outcome was rate of change ( slope analysis ) from baseline to 12 months in Unified Multiple System Atrophy Rating Scale ( UMSARS ) I score , analysed in all participants with at least one post-baseline measurement .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT01287221 .
-RESULTS	Between April 22 , 2011 , and April 19 , 2012 , we randomly assigned 100 participants ( 50 to rifampicin and 50 to placebo ) .
-RESULTS	Four participants in the rifampicin group and five in the placebo group withdrew from study prematurely .
-RESULTS	Results of the preplanned interim analysis ( n = 15 in each group ) of the primary endpoint showed that futility criteria had been met , and the trial was stopped ( the mean rate of change [ slope analysis ] of UMSARS I score was 0.62 points [ SD 0.85 ] per month in the rifampicin group vs 0.47 points [ 0.48 ] per month in the placebo group ; futility p = 0.032 ; efficacy p = 0.76 ) .
-RESULTS	At the time of study termination , 49 participants in the rifampicin group and 50 in the placebo group had follow-up data and were included in the final analysis .
-RESULTS	The primary endpoint was 0.5 points ( SD 0.7 ) per month for rifampicin and 0.5 points ( 0.5 ) per month for placebo ( difference 0.0 , 95 % CI -0.24 to 0.24 ; p = 0.82 ) .
-RESULTS	Three ( 6 % ) of 50 participants in the rifampicin group and 12 ( 24 % ) of 50 in the placebo group had one or more serious adverse events ; none was thought to be related to treatment .
-CONCLUSIONS	Our results show that rifampicin does not slow or halt progression of multiple system atrophy .
-CONCLUSIONS	Despite the negative result , the trial does provide information that could be useful in the design of future studies assessing potential disease modifying therapies in patients with multiple system atrophy .
-BACKGROUND	National Institutes of Health , Mayo Clinic Center for Translational Science Activities , and Mayo Funds .
-
-###25086490
-BACKGROUND	There is no consensus on what type of arthroplasty is best for the treatment of complex proximal humeral fractures in elderly patients .
-BACKGROUND	The purpose of this prospective study was to compare the outcomes of reverse shoulder arthroplasty ( RSA ) and hemiarthroplasty ( HA ) .
-METHODS	Sixty-two patients older than 70 years were randomized to RSA ( 31 patients ) and HA ( 31 patients ) .
-METHODS	One HA patient died at 1 year , and she was excluded .
-METHODS	The mean follow-up was 28.5 months ( range , 24-49 months ) .
-RESULTS	Compared with HA patients , RSA patients had significantly higher ( P = .001 ) mean University of California-Los Angeles ( 29.1 vs 21.1 ) and Constant ( 56.1 vs 40.0 ) scores , forward elevation ( 120.3 vs 79.8 ) , and abduction ( 112.9 vs 78.7 ) but no difference in internal rotation ( 2.7 vs 2.6 ; P = .91 ) .
-RESULTS	The Disabilities of the Arm , Shoulder , and Hand score was higher in the HA patients ( 17 vs 29 ; P = .001 ) .
-RESULTS	In the HA group , 56.6 % of tuberosities healed and 30 % resorbed .
-RESULTS	Patients with failure of tuberosities had significantly worse functional outcomes .
-RESULTS	There were 2 complications ( intraoperative humeral fracture and superficial infection ) .
-RESULTS	One patient was manipulated under general anesthesia because of postoperative stiffness .
-RESULTS	Six patients with HA had proximal migration that required revision to RSA .
-RESULTS	In the RSA group , 64.5 % of tuberosities healed and 13.2 % resorbed .
-RESULTS	Functional outcome was irrespective of healing of the tuberosities .
-RESULTS	Notching was observed in only 1 RSA patient .
-RESULTS	One patient developed a hematoma and another a deep infection requiring a 2-stage revision to another RSA .
-CONCLUSIONS	RSA resulted in better pain and function and lower revision rate .
-CONCLUSIONS	Revision from HA to RSA does not appear to improve outcomes .
-
-###24313693
-OBJECTIVE	This study examined the feasibility of a prototype Web-based acceptance and commitment therapy ( ACT ) program for preventing mental health problems among college students .
-METHODS	Undergraduate first-year students ( N = 76 ) participated between May and November 2011 .
-METHODS	Participants were randomized to ACT or a waitlist , with assessments conducted at baseline , posttherapy , and 3-week follow-up .
-METHODS	Waitlist participants accessed the program after the second assessment .
-RESULTS	Program usability/usage data indicated high program acceptability .
-RESULTS	Significant improvements were found for ACT knowledge , education values , and depression with ACT relative to waitlist .
-RESULTS	Subgroup analyses indicated that ACT decreased depression and anxiety relative to waitlist among students with at least minimal distress .
-RESULTS	Within the ACT condition , significant improvements were observed from baseline to 3-week follow-up on all outcome and process measures .
-CONCLUSIONS	Results provide preliminary support for the feasibility of a Web-based ACT prevention program .
-
-###26074397
-OBJECTIVE	Breast International Group ( BIG ) 2-98 is a randomised phase III trial that tested the effect of adding docetaxel , either in sequence to or in combination with anthracycline-based adjuvant chemotherapy , in women with node-positive breast cancer ( BC ) .
-OBJECTIVE	Here , we present the 10-year final trial safety and efficacy analyses .
-OBJECTIVE	We also report an exploratory analysis on the predictive value of Ki67 for docetaxel efficacy , in the BIG 2-98 and using a pooled analysis of three other randomised trials .
-METHODS	2887 patients were randomly assigned in a 22 trial design to one of four treatments .
-METHODS	The primary objective was to evaluate the overall efficacy of docetaxel on disease free survival ( DFS ) .
-METHODS	Secondary objectives included comparisons of sequential docetaxel versus sequential control arm , safety and overall survival ( OS ) .
-METHODS	Ki67 expression was centrally evaluated by immunohistochemistry .
-RESULTS	After a median follow-up of 10.1 years , the addition of docetaxel did not significantly improve DFS or OS ( hazard ratio ( HR ) = 0.91 , 95 % confidence interval ( CI ) = 0.81-1 .04 ; P = 0.16 and HR = 0.88 , 95 % CI = 0.76-1 .03 ; P = 0.11 , respectively ) .
-RESULTS	Sequential docetaxel did not improve DFS compared to the sequential control arm ( HR = 0.86 , 95 % CI = 0.72-1 .03 ; P = 0.10 ) .
-RESULTS	In oestrogen receptor ( ER ) - positive tumours with Ki6714 % , the addition of docetaxel resulted in 5.4 % improvement in 10-year OS ( P = 0.03 , test for interaction = 0.1 ) .
-RESULTS	In a multivariate model , there was a trend for improved DFS and OS in ER-positive patients with high Ki67 and treated with docetaxel ( HR = 0.79 , 95 % CI = 0.63-1 .01 ; P = 0.05 and HR = 0.76 , 95 % CI = 0.57-1 .01 ; P = 0.06 , respectively ) .
-RESULTS	A pooled analysis of four randomised trials showed a benefit of taxanes in highly proliferative ER-positive disease but not in low proliferating tumours ( interaction test P = 0.01 ) .
-CONCLUSIONS	The DFS benefit previously demonstrated with sequential docetaxel is no longer observed at 10years .
-CONCLUSIONS	However , an exploratory analysis suggested a benefit of docetaxel in patients with highly proliferative ER-positive BC .
-
-###25298352
-OBJECTIVE	A wide range of herbal plants have been reported to treat various gynecological problems of women .
-OBJECTIVE	This study was set out to investigate the effect of ginger ( Zingiber officinale ) on heavy menstrual bleeding ( HMB ) in high school girls .
-METHODS	Ninety-two young women who experienced HMB and met the inclusion criteria were recruited in this study .
-METHODS	Participants were evaluated for six consecutive menstrual cycles .
-METHODS	During 3 assessment cycles , their HMB was confirmed by Pictorial Blood Assessment Chart .
-METHODS	They were then randomly allocated to two study groups to receive either ginger or placebo capsules .
-METHODS	The participants filled in the same chart during three intervention cycles .
-RESULTS	The level of menstrual blood loss dramatically declined during the three intervention cycles in ginger-receiving group .
-RESULTS	The decrease of blood loss in ginger-receiving group was significantly more remarkable than that of participants receiving placebo ( p < 0.001 ) .
-RESULTS	Minimum number of participants reported adverse effects .
-CONCLUSIONS	HMB is highly prevalent among young women .
-CONCLUSIONS	Considering the significance of appropriate and timely treatment and also the importance of prevention of unwanted consequences , ginger may be considered as an effective therapeutic option for HMB .
-
-###24612414
-BACKGROUND	Early oral feeding ( EOF ) following colorectal surgery can accelerate patient recovery and shorten hospital stay .
-BACKGROUND	However , some patients are intolerable to postoperative early oral feeding .
-BACKGROUND	The aim of this study was to evaluate the tolerability of EOF following laparoscopic colorectal cancer surgery and the effects of intravenous lidocaine .
-METHODS	The cohort in this randomized , placebo-controlled trial ( ClinicalTrial.gov , NCT01346917 ) comprised of 77 patients undergoing elective laparoscopic colorectal cancer surgery .
-METHODS	For patients randomized to the lidocaine group , a loading dose of 1mg/kg lidocaine prior to skin incision , and a continuous dose of 1mg/kg/h lidocaine with 90mg ketorolac ( non-steroidal anti-inflammatory drug ) ( in normal saline , total 240mL ) was administered for 24h .
-METHODS	Patients randomized to the placebo group received a loading dose of 5mL saline and a continuous dose of 90mg ketorolac in 240mL saline .
-METHODS	The primary outcome measure was prevalence of postoperative nausea/vomiting and intolerance to EOF .
-RESULTS	Altogether , 68 patients completed the study and were analyzed .
-RESULTS	Postoperative nausea and vomiting were higher in the control group but did not reach statistical significance ( P = 0.054 ) .
-RESULTS	Tolerability of EOF was 96.9 % in the lidocaine group and 91.7 % in the control group ( P = 0.62 ) .
-RESULTS	There was no difference in postoperative pain , opioid consumption , bowel function recovery or postoperative hospital stay .
-CONCLUSIONS	Perioperative intravenous lidocaine administered for laparoscopic colorectal cancer surgery might reduce postoperative nausea and vomiting .
-CONCLUSIONS	However , a high tolerability to EOF following colorectal surgery can be achieved by laparoscopic surgery alone without other supportive treatment .
-
-###25833732
-BACKGROUND	Developing and evaluating interventions for patients with age-associated disorders is a rising field in psychotherapy research .
-BACKGROUND	Its methodological challenges include the high between-subject variability and the wealth of influencing factors associated with longer lifetime .
-BACKGROUND	Latent change score modeling ( LCSM ) , a technique based on structural equation modeling , may be well suited to analyzing longitudinal data sets obtained in clinical trials .
-BACKGROUND	Here , we used LCSM to evaluate the antidepressant effect of a combined cognitive behavioral/cognitive rehabilitation ( CB/CR ) intervention in Alzheimer 's disease ( AD ) .
-METHODS	LCSM was applied to predict the change in depressive symptoms from baseline as an outcome of the CORDIAL study , a randomized controlled trial involving 201 patients with mild AD .
-METHODS	The participants underwent either the CORDIAL CB/CR program or standard treatment .
-METHODS	Using LCSM , the model best predicting changes in Geriatric Depression Scale scores was determined based on this data set .
-RESULTS	The best fit was achieved by a model predicting a decline in depressive symptoms between before and after testing .
-RESULTS	Assignment to the intervention group as well as female gender revealed significant effects in model fit indices , which remained stable at 6 - and 12-month follow-up examinations .
-RESULTS	The pre-post effect was pronounced for patients with clinically relevant depressive symptoms at baseline .
-CONCLUSIONS	LCSM confirmed the antidepressant effect of the CORDIAL therapy program , which was limited to women .
-CONCLUSIONS	The effect was pronounced in patients with clinically relevant depressive symptoms at baseline .
-CONCLUSIONS	Methodologically , LCSM appears well suited to analyzing longitudinal data from clinical trials in aged populations , by accounting for the high between-subject variability and providing information on the differential indication of the probed intervention .
-
-###25850425
-BACKGROUND	The aim of this study is to examine the relationship between time in the therapeutic range ( TTR ) and clinical outcomes in heart failure patients in sinus rhythm treated with warfarin .
-RESULTS	We used data from the Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction ( WARCEF ) trial to assess the relationship of TTR with the WARCEF primary outcome ( ischemic stroke , intracerebral hemorrhage , or death ) , with death alone , ischemic stroke alone , major hemorrhage alone , and net clinical benefit ( primary outcome and major hemorrhage combined ) .
-RESULTS	Multivariable Cox models were used to examine how the event risk changed with TTR and to compare the high TTR , low TTR , and aspirin-treated patients , with TTR being treated as a time-dependent covariate .
-RESULTS	A total of 2217 patients were included in the analyses ; among whom 1067 were randomized to warfarin and 1150 were randomized to aspirin .
-RESULTS	The median ( interquartile range ) follow-up duration was 3.6 ( 2.0-5 .0 ) years .
-RESULTS	Mean ( SD ) age was 6111.3 years , with 80 % being men .
-RESULTS	The mean ( SD ) TTR was 57 % ( 28.5 % ) .
-RESULTS	Increasing TTR was significantly associated with reduction in primary outcome ( adjusted P < 0.001 ) , death alone ( adjusted P = 0.001 ) , and improved net clinical benefit ( adjusted P < 0.001 ) .
-RESULTS	A similar trend was observed for the other 2 outcomes , but significance was not reached ( adjusted P = 0.082 for ischemic stroke and adjusted P = 0.109 for major hemorrhage ) .
-CONCLUSIONS	In patients with heart failure in sinus rhythm , increasing TTR is associated with better outcome and improved net clinical benefit .
-CONCLUSIONS	Patients in whom good quality anticoagulation can be achieved may benefit from the use of anticoagulants .
-BACKGROUND	URL : http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00041938 .
-
-###25098777
-OBJECTIVE	To assess the adequacy of different amounts of local anesthetics ( LA ) in infraclavicular blockade ( ICB ) under ultrasonographic ( US ) guidance and neurostimulation and compare them to the conventional doses under neurostimulation ( NS ) .
-METHODS	In this study 100 patients scheduled for upper limb surgery and suitable for ICB were randomly allocated to 1 of 5 groups : group NS ( NS alone group 0.5 ml/kg LA ) , group FD ( full-dose US group 0.5 ml/kg LA ) , group 30 ( 30 % reduced dose LA 0.35 ml/kg ) , group 50 ( 0.25 ml/kg LA ) and group 70 ( 0.15 ml/kg LA ) .
-METHODS	The ICB was performed under US in conjunction with NS in all groups except group NS in which neurostimulation was used alone .
-METHODS	When necessary local anesthetic supplementation to the operation site was administered during surgery and propofol infusion for sedation ensued .
-METHODS	Evaluation of sensory and motor block was performed for each terminal nerve ( i.e. radial , ulnar , median and musculocutaneous nerves ) .
-METHODS	Block quality ( assessing the need for rescue LA and propofol sedation ) and duration of the block were documented .
-RESULTS	None of the patients in the FD and 30 groups required any supplementation or sedation , whereas LA supplementation rates were 5 % in group 50 and 10 % in groups 70 and NS .
-RESULTS	The propofol sedation rates were 20 % in group NS , 25 % in group 50 and 40 % in group 70 .
-RESULTS	Sensory block was significantly better in groups FD , 30 and NS at 30 min .
-RESULTS	A complete block was achieved more rapidly in all nerve territories in the full-dose group ( p = 0.0001 ) .
-RESULTS	Block duration was longest in group FD and was significantly longer in group 30 than in the other two groups ( p = 0.0001 ) .
-CONCLUSIONS	The results show that US guidance is more effective in maintenance of successful ICB than neurostimulation guidance alone and a reduction of LA doses even to 70 % of conventionally used doses seems possible with US guidance .
-CONCLUSIONS	This article is published in English .
-
-###25074072
-OBJECTIVE	This study aimed to compare the effectiveness and safety of triphasic combined oral contraceptives ( OCs ) containing ethinyl estradiol ( EE ) and norgestimate ( NGM ) and biphasic combined OCs containing EE and desogestrel ( DSG ) in the treatment of mild to moderate acne .
-METHODS	This was an investigator-blinded , randomized , parallel group trial conducted at 3 centers in Thailand .
-METHODS	Female subjects 18-45 years old were assigned to one or the other OCs and evaluated for efficacy and safety parameters at the baseline visit and after 1 , 3 and 6 months of treatment .
-RESULTS	Among 201 randomized subjects , data from 93 subjects in the EE/NGM group and 95 subjects in the EE/DSG group were analyzed .
-RESULTS	After 6 months of treatment with EE/NGM and EE/DSG , no differences between formulations were found for the decrease in total acne lesion counts ( 74.4 % vs. 65.1 % , respectively , p = .070 ) or facial improvement score .
-RESULTS	More women using EE/NGM showed a decrease in severity of facial seborrhea than those using EE/DSG ( p = .005 ) .
-RESULTS	No changes in weight were noted in either group as compared to baseline .
-CONCLUSIONS	Multiphasic OCs containing EE/NGM and EE/DSG provided comparable efficacy and tolerability in the treatment of acne .
-CONCLUSIONS	However , EE/NGM had a more beneficial effect on facial seborrhea reduction than EE/DSG .
-CONCLUSIONS	EE/NGM and EE/DSG are multiphasic OCs , which were shown to be clinically equally effective for mild to moderate facial acne , and the multiphasic combined OC with NGM was more effective for women with facial seborrhea .
-CONCLUSIONS	Clinicians may apply the results of this study when considering treatment options for facial acne and seborrhea .
-
-###24305424
-BACKGROUND	Forehead and glabella rhytides are treated mostly with neurotoxins , although some practitioners prefer the concurrent use of fillers .
-BACKGROUND	It has been suggested that combination treatments can result in a better overall improvement .
-OBJECTIVE	To compare the safety and effectiveness of treatment of forehead and glabellar lines with botulinum toxin A alone versus botulinum toxin A and filler .
-METHODS	Split-face , randomized control trial .
-METHODS	Twenty subjects with forehead/glabellar rhytide complex ( static and dynamic creases ) enrolled .
-METHODS	Subjects were randomized and injected with botulinum toxin alone on one side of the forehead/glabella and hyaluronic acid filler followed by botulinum toxin on the other side .
-METHODS	Blinded ratings were obtained to assess the effectiveness of treatment for static and dynamic rhytides , respectively , at 2-week , 6-week , 3-month , and 6-month follow-up visits .
-METHODS	Subjects performed a self-evaluation at the end of the study .
-METHODS	Adverse events were recorded .
-RESULTS	Ratings of both treatments showed comparable efficacy , with 100 % of subjects experiencing improvement from baseline regardless of treatment type at weeks 2 , 6 , and 12 .
-RESULTS	Combination treatment produced longer-lasting results in dynamic forehead wrinkles , and greater static and dynamic wrinkle reduction in the glabella at week 24 .
-RESULTS	Subject self-evaluations showed that both treatments were effective , with a nominal preference for combination treatment .
-CONCLUSIONS	Glabella and forehead lines can be effectively and safely reduced with neurotoxin alone as well as neurotoxin in combination with fillers .
-CONCLUSIONS	Combination treatment may provide a slightly better cumulative benefit and also increase the persistence of effect .
-
-###24797938
-OBJECTIVE	Remote ischemic preconditioning ( RIPC ) by repeated brief limb ischemia/reperfusion reduces myocardial injury in patients undergoing coronary artery bypass grafting ( CABG ) .
-OBJECTIVE	Activation of signal transducer and activator of transcription 5 ( STAT5 ) in left ventricular ( LV ) myocardium at early reperfusion is associated with such protection .
-OBJECTIVE	Autophagy , i.e. , removal of dysfunctional cellular components through lysosomes , has been proposed as one mechanism of cardioprotection .
-OBJECTIVE	Therefore , we analyzed whether or not the protection by RIPC is associated with activated autophagy .
-METHODS	CABG patients were randomized to undergo RIPC ( 35 min blood pressure cuff inflation/5 min deflation ) or placebo ( cuff deflated ) before skin incision ( n = 10/10 ) .
-METHODS	Transmural myocardial biopsies were taken from the LV before cardioplegia ( baseline ) and at early ( 5-10 min ) reperfusion .
-METHODS	RIPC-induced protection was reflected by decreased serum troponin I concentration area under the curve ( 19417 versus 709129 ng/ml 72 h , p = 0.002 ) .
-METHODS	Western blotting for beclin-1-phosphorylation and protein expression of autophagy-related gene 5-12 ( ATG5-12 ) complex , light chain 3 ( LC3 ) , parkin , and p62 was performed .
-METHODS	STAT3 - , STAT5 - and extracellular signal-regulated protein kinase 1/2 ( ERK1/2 ) - phosphorylation was used as positive control to confirm signal activation by ischemia/reperfusion .
-RESULTS	Signals of all analyzed autophagy proteins did not differ between baseline and early reperfusion and not between RIPC and placebo .
-RESULTS	STAT5-phosphorylation was greater at early reperfusion only with RIPC ( 2.2-fold , p = 0.02 ) .
-RESULTS	STAT3 - and ERK1/2-phosphorylation were greater at early reperfusion with placebo and RIPC ( 2.7-fold versus baseline , p0 .05 ) .
-CONCLUSIONS	Protection through RIPC in patients undergoing CABG surgery does not appear to be associated with enhanced autophagy in LV myocardium at early reperfusion .
-
-###25055152
-OBJECTIVE	The aim of this study was to evaluate the treatment effect of diquafosol 3 % with preservative-free sodium hyaluronate 0.1 % eye drops in dry eye syndrome .
-METHODS	In total , 150 patients with dry eye syndrome were divided randomly into 3 groups .
-METHODS	Group 1 ( 50 patients ) was treated 4 times daily with preserved sodium hyaluronate 0.1 % , group 2 ( 50 patients ) was treated 4 times daily with diquafosol 3 % , and group 3 ( 50 patients ) was treated 4 times daily with diquafosol 3 % and preservative-free sodium hyaluronate 0.1 % eye drops for 3 months .
-METHODS	Ocular surface disease index ( OSDI ) score , tear film break-up time , Schirmer I test , corneal fluorescein staining , and impression cytology were evaluated .
-RESULTS	There were significant improvements in the OSDI score , tear film break-up time , Schirmer I score , fluorescein and Rose Bengal staining , goblet cell density , and impression cytological findings in groups 2 and 3 compared with those for group 1 in patients with dry eye syndrome at 1 , 2 , and 3 months ( P < 0.05 ) .
-RESULTS	There were statistically significant improvements in the OSDI score ( -8.48 0.97 , -5.69 0.78 ; P = 0.02 ) , fluorescein ( -1.43 0.21 , -1.02 0.18 ; P = 0.03 ) , and Rose Bengal staining ( -1.12 0.26 , -0.75 0.12 ; P = 0.03 ) , goblet cell density ( 89.65 14.39 , 70.36 16.75 ; P = 0.03 ) , and impression cytological findings ( -0.53 0.12 , -0.34 0.90 ; P = 0.01 ) in group 3 compared with those in group 2 at 3 months .
-CONCLUSIONS	Treatment with diquafosol 3 % with preservative-free sodium hyaluronate 0.1 % was more effective than diquafosol 3 % monotherapy or treatment with preserved sodium hyaluronate 0.1 % in dry eye syndrome .
-CONCLUSIONS	Preservative-free sodium hyaluronate 0.1 % eye drops can increase the effect of diquafosol 3 % in dry eye syndrome .
-
-###24853958
-BACKGROUND	The aim of this prospective comparative study was to compare outcomes and complications of humeral diaphyseal fracture non-unions managed with humerus interlocking nail ( HIL ) and locking compression plate ( LCP ) .
-METHODS	40 patients with non-union of humeral diaphyseal fractures were included in this study and were randomly allocated in two groups ; group A had 20 cases treated with HIL and group B had 20 cases treated with LCP .
-METHODS	Clinico-radiological assessments were done for each case up to 2-year follow-up period .
-METHODS	Primary outcome measures ( time to fracture union , union rate ) and secondary outcome measures ( functional outcome and complication such as infection , malunion , delayed union , implant failure , joint stiffness and iatrogenic radial nerve palsy ) were compared between both the groups .
-METHODS	Disabilities of the arm , shoulder and hand ( DASH ) scoring and Steward and Hundley 's scoring system were used to assess functional outcome of the fracture fixation .
-RESULTS	There was no significant difference ( p = 0.12 ) in terms of mean fracture union time between group A ( 15.8 4.2 weeks ) and group B ( 17.2 3.8 weeks ) .
-RESULTS	Group A had 95 % union rate and group B had 100 % union rate ( p = 0.14 ) .
-RESULTS	At the 2-year follow-up visit , there was no significant difference found between both the groups regarding range of motion of shoulder and elbow joint .
-RESULTS	There was no significant difference found in final functional outcomes between both the groups on comparing DASH score ( p = 0.14 ) and Steward and Hundley 's score ( p = 0.08 ) .
-RESULTS	In terms of complications , there was insignificant difference found between both the groups .
-CONCLUSIONS	This study concludes that both the implants can be used in non-union of humeral shaft fractures with good functional outcomes and acceptable rate of complications .
-
-###25764956
-OBJECTIVE	The aim of the study was to compare the efficacy of a microorganism-binding ( MB ) dressing with a silver-containing hydrofiber ( SCH ) dressing in controlling the bacterial loads of heavily colonised or locally infected chronic venous leg ulcers , before surgical management with homologous skin grafts .
-METHODS	A randomised comparative single centre study recruited patients presenting with hard-to-heal critically colonised or locally infected leg ulcers , who could be treated with skin grafting .
-METHODS	Inclusion criteria included ; ulcers of vascular aetiology , over 18 years old , a wound duration 6 months and ankle brachial index ( ABPI ) > 0.6 .
-METHODS	Patients were randomly assigned to treatment with SCH dressings ( Aquacel Ag ) or MB dressing ( Cutimed Sorbact ) .
-METHODS	Dressings were changed daily over a four-day observation period , after which they were taken for a skin grafting procedure .
-METHODS	Swab samples from ulcer beds were taken in order to quantify the bacterial load at inclusion ( D0 ) and at the end of the observation period day 4 ( D4 ) .
-METHODS	No antibiotics were administered before or during the evaluation period .
-RESULTS	Both groups ( n = 20 SCH , n = 20 MB ) were similar in gender , age , pathophysiology ( both had 15 patients with venous leg ulcers and 5 with arterial leg ulcers ) , ulcer surface , ulcer duration , treatment-related pain and initial bacterial load .
-RESULTS	Analysing bacterial load variation showed a significant reduction of bacterial burden at D4 in both groups .
-RESULTS	In the SCH group , we found an average bacterial load reduction of 41.6 % , with an average reduction of 73.1 % in the MB group ( p < 0.00001 ) .
-RESULTS	No serious adverse events were reported .
-CONCLUSIONS	Our evaluation confirmed that MB and SCH dressings are effective in reducing the bacterial burden in critically colonised or locally infected chronic leg ulcers , without inducing adverse events , with MB dressings significantly more effective .
-BACKGROUND	There were no external sources of funding for this study .
-BACKGROUND	The authors have no conflicts of interest to declare .
-
-###25566977
-OBJECTIVE	The effectiveness of antimicrobial prophylaxis ( AMP ) in the prevention of surgical site infection ( SSI ) following thyroid and parathyroid surgery remains uncertain .
-OBJECTIVE	The objective of this prospective randomized controlled trial ( Ito-RCT1 ) was to assess the effectiveness of AMP in clean neck surgery performed to treat thyroid and parathyroid disease .
-METHODS	Participants comprised patients scheduled for clean neck surgery for thyroid and parathyroid disease at Ito Hospital .
-METHODS	Patients whose surgery included sternotomy or resection of the trachea , larynx , pharynx , or esophagus were excluded .
-METHODS	AMP consisted of 2 g of piperacillin ( PIPC ) ( group A , n = 541 ) or 1 g of cefazolin ( CEZ ) ( group B , n = 541 ) administered intravenously immediately after endotracheal intubation .
-METHODS	Patients in the control group ( Group C , n = 1,082 ) did not receive AMP .
-RESULTS	Statistical analysis was performed to compare the AMP group ( Group A + Group B ) with the control group ( Group C ) .
-RESULTS	Drug-induced acute reactions correlated to PIPC or CEZ did not occur in the AMP group .
-RESULTS	No significant differences in the postoperative incidence of liver or renal dysfunction were seen between the AMP and control groups .
-RESULTS	Postoperative incidence of urinary tract infection was significantly higher in the control group ( p = 0.002 ) .
-RESULTS	The incidence of SSI events was very low , with only 1 event ( 0.09 % ) in the AMP group and 3 events ( 0.28 % ) in the control group , and this difference between groups was not significant ( p = 0.371 ) .
-CONCLUSIONS	AMP is not necessary to prevent SSI after clean thyroid or parathyroid surgery .
-
-###25294097
-OBJECTIVE	To investigate how suppression of endogenous testosterone during an 8-week strength training period influences the activity of satellite cells and myonuclei .
-METHODS	Twenty-two moderately trained young men participated in this randomized , placebo-controlled , and double-blinded intervention study .
-METHODS	The participants were randomized to treatment with a GnRH analogue , goserelin ( n = 12 ) , which suppresses testosterone or placebo ( n = 10 ) for 12 weeks .
-METHODS	The strength training period of 8 weeks started after 4 weeks of treatment and included exercises for all major muscles .
-METHODS	Biopsies were obtained from the mid-portion of the vastus lateralis muscle .
-RESULTS	Testosterone resting level in goserelin was 10-20 times lower compared with placebo , and the training-induced increase in the level of testosterone was abolished in goserelin .
-RESULTS	Training increased satellite cells number in type II fibres by 20 % in placebo and by 52 % in goserelin ( P < 0.01 ) , whereas the myonuclear number significantly increased by 12 % in type II fibres in placebo and remained unchanged in goserelin ( P < 0.05 ) .
-RESULTS	No changes in satellite cells and myonuclei were seen in type I fibres in either group .
-RESULTS	Data from the microarray analysis indicated that low testosterone affects the bone morphogenetic proteins signalling , which might regulate proliferation vs. differentiation of satellite cells .
-CONCLUSIONS	Eight weeks of strength training enhances the myonuclear number in type II fibres , and this is largely blocked by the suppression of testosterone .
-CONCLUSIONS	The data indicate that low testosterone levels could reduce the differentiation of satellite cells to myonuclei via the bone morphogenetic proteins signalling pathway , resulting in reduced increases in lean leg mass .
-
-###24577287
-OBJECTIVE	A previous pilot trial evaluating computer-based training for cognitive-behavioral therapy ( CBT4CBT ) in 77 heterogeneous substance users ( alcohol , marijuana , cocaine , and opioids ) demonstrated preliminary support for its efficacy in the context of a community-based outpatient clinic .
-OBJECTIVE	The authors conducted a more definitive trial in a larger , more homogeneous sample .
-METHODS	In this randomized clinical trial , 101 cocaine-dependent individuals maintained on methadone were randomly assigned to standard methadone maintenance or methadone maintenance with weekly access to CBT4CBT , with seven modules delivered within an 8-week trial .
-RESULTS	Treatment retention and data availability were high and comparable across the treatment conditions .
-RESULTS	Participants assigned to the CBT4CBT condition were significantly more likely to attain 3 or more consecutive weeks of abstinence from cocaine ( 36 % compared with 17 % ; p < 0.05 , odds ratio = 0.36 ) .
-RESULTS	The group assigned to CBT4CBT also had better outcomes on most dimensions , including urine specimens negative for all drugs , but these reached statistical significance only for individuals completing the 8-week trial ( N = 69 ) .
-RESULTS	Follow-up data collected 6 months after treatment termination were available for 93 % of the randomized sample ; these data indicate continued improvement for those assigned to the CBT4CBT group , replicating previous findings regarding its durability .
-CONCLUSIONS	This trial replicates earlier findings indicating that CBT4CBT is an effective adjunct to addiction treatment with durable effects .
-CONCLUSIONS	CBT4CBT is an easily disseminable strategy for broadening the availability of CBT , even in challenging populations such as cocaine-dependent individuals enrolled in methadone maintenance programs .
-
-###25837829
-BACKGROUND	Hepatitis C virus ( HCV ) genotype 4 accounts for about 13 % of global HCV infections .
-BACKGROUND	Because interferon-containing treatments for genotype 4 infection have low efficacy and poor tolerability , an unmet need exists for effective all-oral regimens .
-BACKGROUND	We examined the efficacy and safety of an all-oral interferon-free regimen of ombitasvir , an NS5A inhibitor , and paritaprevir ( ABT-450 ) , an NS3/4A protease inhibitor dosed with ritonavir ( ombitasvir plus paritaprevir plus ritonavir ) , given with or without ribavirin .
-METHODS	In this multicentre ongoing phase 2b , randomised , open-label combination trial ( PEARL-I ) , patients were recruited from academic , public , and private hospitals and clinics in France , Hungary , Italy , Poland , Romania , Spain , Turkey , and the USA .
-METHODS	Eligible participants were aged 18-70 years with non-cirrhotic , chronic HCV genotype 4 infection ( documented 6 months before screening ) and plasma HCV RNA levels higher than 10,000 IU/mL .
-METHODS	Previously untreated ( treatment-naive ) patients were randomly assigned ( 1:1 ) by computer-generated randomisation lists to receive once-daily ombitasvir ( 25 mg ) plus paritaprevir ( 150 mg ) plus ritonavir ( 100 mg ) with or without weight-based ribavirin for 12 weeks .
-METHODS	Previously treated ( treatment-experienced ) patients who had received pegylated interferon plus ribavirin all received the ribavirin-containing regimen .
-METHODS	The primary endpoint was a sustained virological response ( HCV RNA < 25 IU/mL ) 12 weeks after the end of treatment ( SVR12 ) .
-METHODS	Analysis was by intention to treat .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT01685203 .
-RESULTS	Between Aug 14 , 2012 , and Nov 19 , 2013 , 467 patients with HCV infection were screened , of whom 174 were infected with genotype 4.135 patients were randomly assigned to treatment and received at least one dose of study medication ; 86 patients were treatment-naive , of whom 44 received ombitasvir plus paritaprevir plus ritonavir and 42 received ombitasvir plus paritaprevir plus ritonavir with ribavirin , and 49 treatment-experienced patients received the ribavirin-containing regimen .
-RESULTS	In previously untreated patients , SVR12 rates were 100 % ( 42/42 [ 95 % CI 916-100 ] ) in the ribavirin-containing regimen and 909 % ( 40/44 [ 95 % CI 783-975 ] ) in the ribavirin-free regimen .
-RESULTS	No statistically significant differences in SVR12 rates were noted between the treatment-naive groups ( mean difference -916 % [ 95 % CI -1961 to 129 ] ; p = 0086 ) .
-RESULTS	All treatment-experienced patients achieved SVR12 ( 49/49 ; 100 % [ 95 % CI 927-100 ] ) .
-RESULTS	In the ribavirin-free group , two ( 5 % ) of 42 treatment-naive patients had virological relapse , and one ( 2 % ) of 44 had virological breakthrough ; no virological failures were recorded in the ribavirin-containing regimen .
-RESULTS	The most common adverse event was headache ( 14 [ 29 % ] of 49 treatment-experienced patients and 14 [ 33 % ] of 42 treatment-naive patients ) .
-RESULTS	No adverse event-related discontinuations or dose interruptions of study medications , including ribavirin , were noted , and only four patients ( 4 % ) of 91 receiving ribavirin required dose modification for haemoglobin less than 100 g/L or anaemia .
-CONCLUSIONS	An interferon-free regimen of ombitasvir plus paritaprevir plus ritonavir with or without ribavirin achieved high sustained virological response rates at 12 weeks after the end of treatment and was generally well tolerated , with low rates of anaemia and treatment discontinuation in non-cirrhotic previously untreated and previously treated patients with HCV genotype 4 infection .
-BACKGROUND	AbbVie .
-
-###25715991
-BACKGROUND	Defibrillation testing by induction and termination of ventricular fibrillation is widely done at the time of implantation of implantable cardioverter defibrillators ( ICDs ) .
-BACKGROUND	We aimed to compare the efficacy and safety of ICD implantation without defibrillation testing versus the standard of ICD implantation with defibrillation testing .
-METHODS	In this single-blind , randomised , multicentre , non-inferiority trial ( Shockless IMPLant Evaluation [ SIMPLE ] ) , we recruited patients aged older than 18 years receiving their first ICD for standard indications at 85 hospitals in 18 countries worldwide .
-METHODS	Exclusion criteria included pregnancy , awaiting transplantation , particpation in another randomised trial , unavailability for follow-up , or if it was expected that the ICD would have to be implanted on the right-hand side of the chest .
-METHODS	Patients undergoing initial implantation of a Boston Scientific ICD were randomly assigned ( 1:1 ) using a computer-generated sequence to have either defibrillation testing ( testing group ) or not ( no-testing group ) .
-METHODS	We used random block sizes to conceal treatment allocation from the patients , and randomisation was stratified by clinical centre .
-METHODS	Our primary efficacy analysis tested the intention-to-treat population for non-inferiority of no-testing versus testing by use of a composite outcome of arrhythmic death or failed appropriate shock ( ie , a shock that did not terminate a spontaneous episode of ventricular tachycardia or fibrillation ) .
-METHODS	The non-inferiority margin was a hazard ratio ( HR ) of 15 calculated from a proportional hazards model with no-testing versus testing as the only covariate ; if the upper bound of the 95 % CI was less than 15 , we concluded that ICD insertion without testing was non-inferior to ICD with testing .
-METHODS	We examined safety with two , 30 day , adverse event outcome clusters .
-METHODS	The trial is registered with ClinicalTrials.gov , number NCT00800384 .
-RESULTS	Between Jan 13 , 2009 , and April 4 , 2011 , of 2500 eligible patients , 1253 were randomly assigned to defibrillation testing and 1247 to no-testing , and followed up for a mean of 31 years ( SD 10 ) .
-RESULTS	The primary outcome of arrhythmic death or failed appropriate shock occurred in fewer patients ( 90 [ 7 % per year ] ) in the no-testing group than patients who did receive it ( 104 [ 8 % per year ] ; HR 086 , 95 % CI 065-114 ; pnon-inferiority < 00001 ) .
-RESULTS	The first safety composite outcome occurred in 69 ( 56 % ) of 1236 patients with no-testing and in 81 ( 65 % ) of 1242 patients with defibrillation testing , p = 033 .
-RESULTS	The second , pre-specified safety composite outcome , which included only events most likely to be directly caused by testing , occurred in 32 % of patients with no-testing and in 45 % with defibrillation testing , p = 008 .
-RESULTS	Heart failure needing intravenous treatment with inotropes or diuretics was the most common adverse event ( in 20 [ 2 % ] of 1236 patients in the no-testing group vs 28 [ 2 % ] of 1242 patients in the testing group , p = 025 ) .
-CONCLUSIONS	Routine defibrillation testing at the time of ICD implantation is generally well tolerated , but does not improve shock efficacy or reduce arrhythmic death .
-BACKGROUND	Boston Scientific and the Heart and Stroke Foundation ( Ontario Provincial office ) .
-
-###24825870
-BACKGROUND	Artemisinin-based combination therapy ( ACT ) has become the standard of care for the treatment of uncomplicated Plasmodium falciparum malaria .
-BACKGROUND	Although several ACT regimens are approved , data guiding optimal choices of ACTs are limited .
-BACKGROUND	We compared short - and long-term outcomes in a cohort of young Ugandan children randomized to 2 leading ACTs .
-METHODS	Overall , 312 children were randomized to artemether-lumefantrine or dihydroartemisinin-piperaquine ( DP ) at the time of the first episode of uncomplicated malaria ( median age , 10.5 months ) .
-METHODS	The same treatment was given for all subsequent episodes of uncomplicated malaria and children were followed until they reached 5 years of age .
-METHODS	The cohort included a subgroup that was human immunodeficiency virus ( HIV ) infected ( n = 44 ) or HIV exposed ( n = 175 ) and prescribed trimethoprim-sulfamethoxazole ( TMP-SMX ) prophylaxis .
-METHODS	Outcomes included time to recurrent malaria following individual treatments and the overall incidences of treatments for malaria , complicated malaria , and hospitalizations .
-RESULTS	Among children not prescribed TMP-SMX prophylaxis , 4443 treatments for malaria were given over 790 person-years following randomization .
-RESULTS	Treatment with DP was associated with a lower hazard of recurrent malaria over the 84 days after treatment ( hazard ratio , 0.66 ; 95 % confidence interval [ CI ] , .61 -.70 ; P < .001 ) .
-RESULTS	Children randomized to DP had a lower incidence of all treatments for malaria ( incidence rate ratio [ IRR ] , 0.85 ; 95 % CI , .75 -.96 ; P = .01 ) , complicated malaria ( IRR , 0.12 ; 95 % CI , .04 -.39 ; P < .001 ) , and hospitalizations ( IRR , 0.31 ; 95 % CI , .13 -.77 ; P = .01 ) .
-RESULTS	Among children prescribed TMP-SMX prophylaxis , there were no significant differences in longitudinal outcomes .
-CONCLUSIONS	Compared to artemether-lumefantrine , the use of DP to treat uncomplicated malaria delayed the time to recurrent malaria and reduced the incidences of treatments for malaria , complicated malaria , and hospitalizations .
-BACKGROUND	NCT00527800 .
-
-###25955443
-OBJECTIVE	The study aimed to investigate the effectiveness of a web-based therapy programme , ` Move it to improve it ' ( Mitii ( ) ) , in children with unilateral cerebral palsy ( UCP ) on occupational performance , upper limb function , and visual perception .
-METHODS	Participants ( n = 102 ) were matched in pairs and randomized to intervention ( Mitii for 20wks ; 26 males , mean age 11y 8mo [ 2y 4mo ] , Manual Ability Classification System level I = 11 , II = 39 , III = 1 ) or control ( standard care ; 25 males , mean age 11y 10mo [ 2y 5mo ] , Manual Ability Classification System level I = 13 , II = 37 ) .
-METHODS	Outcomes were the Assessment of Motor and Process Skills ( AMPS ) , Assisting Hand Assessment , Jebsen-Taylor Test of Hand Function ( JTTHF ) , Melbourne Assessment of Unilateral Upper Limb Function ( MUUL ) , Canadian Occupational Performance Measure ( COPM ) , and Test of Visual Perceptual Skills ( TVPS-3 ) .
-RESULTS	Participants completed on average 32.4 hours of Mitii ( range 3.7-74 .7 h ) .
-RESULTS	The Mitii group demonstrated significantly greater post-intervention scores than the comparison group on the AMPS , JTTHF dominant upper limb , COPM , and TVPS-3 .
-RESULTS	The differences between groups were not clinically significant .
-RESULTS	There were no differences between groups on measures of impaired upper limb function .
-CONCLUSIONS	Mitii delivers individualized , web-based therapy at home and has potential to increase therapy dose .
-CONCLUSIONS	Mitii can be considered as an option to enhance occupational performance and visual perception for children with UCP .
-
-###24682569
-OBJECTIVE	Inappropriate implantable cardioverter defibrillators ( ICD ) therapies have been associated with multiple adverse effects , including worse quality of life and prognosis .
-OBJECTIVE	We evaluated the possibility of predicting atrial fibrillation ( AF ) - related inappropriate ICD shocks through continuous monitoring of device diagnostics .
-METHODS	1404 ICD patients were prospectively followed in an observational research by 74 Italian cardiology centres .
-METHODS	Device diagnostics stored daily information on AF duration and ventricular rate ( VR ) during AF .
-METHODS	Uncontrolled VR was defined as mean VR > 80 beats per minute ( bpm ) and maximum VR > 110 bpm .
-METHODS	Expert electrophysiologists reviewed the ventricular tachycardia/ventricular fibrillation ( VT/VF ) episodes electrograms , stored in the device memory , and classified appropriate detections , inappropriate detection mechanisms and ICD therapy outcomes .
-RESULTS	Over a median follow-up of 31 months , 511 ( 36 % ) patients suffered spontaneous VT/VF , which were treated by ICD shocks in a subgroup of 189 ( 13 % ) patients .
-RESULTS	Inappropriate detections occurred in 232 ( 16 % ) patients , and inappropriate ICD shocks in 101 ( 7 % ) patients .
-RESULTS	AF was the cause of inappropriate shocks in 60 patients .
-RESULTS	AF caused 144 inappropriate shocks : 53 % of all inappropriate shocks .
-RESULTS	The likelihood of experiencing AF-related inappropriate shocks was 2.4 % at 1 year and 6 % at 5 years .
-RESULTS	Uncontrolled VR during AF proved to be an independent predictor of AF-related inappropriate shocks ( OR = 3.02 , p = 0.006 ) ; an alarm set at a VR > 90 bpm or 100 bpm was associated with prediction of AF-related inappropriate shocks with a sensitivity of 73 % or 62 % , respectively .
-CONCLUSIONS	AF is the most common cause of inappropriate shocks in ICD patients .
-CONCLUSIONS	Continuous remote monitoring of VR during AF would promptly and efficiently predict AF-related inappropriate shocks .
-BACKGROUND	http://clinicaltrials.gov/ct2/show/NCT01007474 .
-
-###24597260
-OBJECTIVE	To explore the effect of patient-controlled lumbar epidural combined anesthesia with Doula for labor analgesia with ropivacaine and sufentanil , and its influence on the progress of labor , and outcomes of mother and infant .
-METHODS	Two hundred parturients that requested labor analgesia were randomly selected by patient-controlled lumbar epidural combined anesthesia with Doula as the observation group , meanwhile another 200 parturients were selected as the control group without any analgesic measurements .
-METHODS	Labor pain score , labor duration , blood gas analysis results , the incidence of cesarean section , neonatal asphyxia , and postpartum hemorrhage were compared between the two groups .
-RESULTS	Compared with the control group , labor analgesic effect was remarkable , the cesarean section rate was significantly reduced in observation group , and the difference was statistically significant ( p < 0.05 ) , but with respect to the duration of labor , maternal , postpartum hemorrhage , and neonatal asphyxia , there was no statistical significance between the two groups ( p > 0.5 ) .
-RESULTS	In the observation group regarding maternal and neonatal blood gas analysis results , PO2 was higher and PCO2 was lower than those in the control group .
-RESULTS	The differences were statistically significant ( p < 0.05 ) .
-CONCLUSIONS	Labor analgesia by patient-controlled lumbar epidural combined anesthesia accompanied with Doula with ropivacaine and sufentanil is effective , safe , reliable , has no adverse effects , and reduces cesarean section rate .
-
-###24582813
-OBJECTIVE	Ventricular arrhythmias are common after acute myocardial infarction ( AMI ) .
-OBJECTIVE	Endothelin ( ET ) is a mediator of microvascular dysfunction and cardiac remodeling with arrhythmogenic potential .
-OBJECTIVE	The aim of this study was to assess safety and feasibility of selective ET-A receptor blockade in ST-elevation acute coronary syndrome ( STE-ACS ) within a larger randomized trial .
-METHODS	Patients with posterior-wall STE-ACS were randomly assigned to receive intravenous BQ-123 at 400 nmol/min or placebo over 60 min , starting immediately prior to primary percutaneous coronary intervention .
-METHODS	Twenty-four hour Holter recordings were performed during hospitalization for STE-ACS and after 6-8 weeks .
-METHODS	The predefined primary endpoint was the documentation of ventricular tachycardia and/or late potentials at follow-up .
-RESULTS	There was no significant difference in the predefined primary endpoint at 45 ( 33-62 ) days ( 0/16 ( 0 % ) in BQ-123 treated patients vs. 1/14 ( 7 % ) in the placebo group , p = 0.465 ) .
-RESULTS	At 2 ( 1-3 ) days , an increase in the total number of supraventricular extrasystoles ( SVES ) / 24 h in patients randomized to BQ-123 ( 45 ( 17-165 ) beats vs. 11 ( 5-72 ) beats in placebo treated patients , p = 0.025 ) occurred .
-RESULTS	This increase was also observed at 45 days ( 105 ( 37-216 ) beats vs. 11 ( 3-98 ) beats in placebo treated patients , p = 0.037 ) .
-RESULTS	There was no significant difference regarding other rhythmologic secondary endpoints between the two groups .
-CONCLUSIONS	Based on the analysis of long-term ECG data , short-term administration of BQ-123 after AMI was safe .
-CONCLUSIONS	Because of the small sample size , no firm conclusion regarding antiarrhythmic efficacy can be drawn .
-
-###24619321
-BACKGROUND	Hypertension self-management has been shown to improve systolic blood pressure ( BP ) control , but longer-term economic and clinical impacts are unknown .
-BACKGROUND	The purpose of this article is to examine clinical and economic outcomes 18 months after completion of a hypertension self-management trial .
-RESULTS	This study is a follow-up analysis of an 18-month , 4-arm , hypertension self-management trial of 591 veterans with hypertension who were randomized to usual care or 1 of 3 interventions .
-RESULTS	Clinic-derived systolic blood pressure obtained before , during , and after the trial were estimated using linear mixed models .
-RESULTS	Inpatient admissions , outpatient expenditures , and total expenditures were estimated using generalized estimating equations .
-RESULTS	The 3 telephone-based interventions were nurse-administered health behavior promotion , provider-administered medication adjustments based on hypertension treatment guidelines , or a combination of both .
-RESULTS	Intervention calls were triggered by home BP values transmitted via telemonitoring devices .
-RESULTS	Clinical and economic outcomes were examined 12 months before , 18 months during , and 18 months after trial completion .
-RESULTS	Compared with usual care , patients randomized to the combined arm had greater improvement in proportion of BP control during and after the 18-month trial and estimated proportion of BP control improved 18 months after trial completion for patients in the behavioral and medication management arms .
-RESULTS	Among the patients with inadequate baseline BP control , estimated mean systolic BP was significantly lower in the combined arm as compared with usual care during and after the 18-month trial .
-RESULTS	Utilization and expenditure trends were similar for patients in all 4 arms .
-CONCLUSIONS	Behavioral and medication management can generate systolic BP improvements that are sustained 18 months after trial completion .
-BACKGROUND	URL : http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00237692 .
-
-###24638865
-BACKGROUND	Melanocytic nevi ( MN ) are the most important simulants of melanoma .
-BACKGROUND	Although acquired nevi are usually clinically stable , they may show abnormal clinical behavior .
-BACKGROUND	This study assessed the histological changes and prognosis of acquired MN with changing clinical behavior in Egyptian patients .
-METHODS	The study included 236 patients that were classified into two groups ; Group A included nevi with abnormal clinical presentation and Group B included clinically typical nevi .
-RESULTS	Each group included 118 patients with a predominance of female patients .
-RESULTS	Abnormal clinical presentation in Group A included altered pigmentation ( 35.6 % ) , rapid enlargement ( 30.5 % ) , keratotic changes ( 16.9 % ) , inflammation ( 7.6 % ) , ulceration ( 5.1 % ) , and hemorrhage ( 4.2 % ) .
-RESULTS	Typical histological features were significantly higher ( p = 0.008 ) in Group B ( 99.2 % ) compared with Group A ( 87.3 % ) .
-RESULTS	Atypical histological features were significantly higher ( p = 0.002 ) in Group A , with higher numbers of ulcerative and altered pigmented nevi .
-RESULTS	Malignant changes showed no significant difference ( p = 0.47 ) between the two groups .
-RESULTS	No relapse was recorded after excision of any lesion .
-CONCLUSIONS	Among Egyptians , changing clinical behavior of MN may show histological atypia but low risk of malignant transformation .
-CONCLUSIONS	Early excision and follow-up of ulcerative and altered pigmented nevi are recommended .
-
-###24273046
-BACKGROUND	The GeparQuattro study showed that adding capecitabine or prolonging the duration of anthracycline-taxane-based neoadjuvant chemotherapy from 24 to 36 weeks did not increase pathological complete response ( pCR ) rates .
-BACKGROUND	Trastuzumab-treated patients with HER2-positive disease showed a higher pCR rate than patients with HER2-negative disease treated with chemotherapy alone .
-BACKGROUND	We here present disease-free ( DFS ) and overall survival ( OS ) analyses .
-METHODS	Patients ( n = 1495 ) with cT 3 tumors , or negative hormone-receptor status , or positive hormone-receptor and clinically node-positive disease received four times epirubicin/cyclophosphamide and were thereafter randomly assigned to four times docetaxel ( Taxotere ) , or four times docetaxel/capecitabine over 24 weeks , or four times docetaxel followed by capecitabine over 36 weeks .
-METHODS	Patients with HER2-positive tumors received 1 year of trastuzumab , starting with the first chemotherapy cycle .
-METHODS	Follow-up was available for a median of 5.4 years .
-RESULTS	Outcome was not improved for patients receiving capecitabine ( HR 0.92 ; P = 0.463 for DFS and HR 93 ; P = 0.618 for OS ) as well as for patients receiving 36 weeks of chemotherapy ( HR 0.97 ; P = 0.818 for DFS and HR 0.97 ; P = 0.825 for OS ) .
-RESULTS	Trastuzumab-treated patients with HER2-positive disease showed similar DFS ( P = 0.305 ) but a significantly better adjusted OS ( P = 0.040 ) when compared with patients with HER2-negative disease treated with chemotherapy alone .
-RESULTS	Recorded long-term cardiac toxicity was low .
-CONCLUSIONS	Long-term results , similar to the results of pCR , do not support the use of capecitabine in the neoadjuvant setting in addition to an anthracycline-taxane-based chemotherapy .
-CONCLUSIONS	However , the results support previous data showing a benefit of trastuzumab as predicted by higher pCR rates .
-
-###24379449
-OBJECTIVE	This randomized controlled pilot trial was conducted to evaluate the clinical efficacy of massage therapy ( MT ) for relief of symptoms of gastroesophageal reflux disease ( GERD ) .
-OBJECTIVE	The hypothesis was that , when compared to infants who received nonmassage therapy , infants who received MT would display fewer GERD symptoms , greater weight gain , greater amount of sleep , lower cortisol levels before and after treatment , and lower daily ( area under the curve [ AUC ] ) cortisol secretion .
-METHODS	Participants were 36 infants born at term , 4-10 weeks of age at enrollment , healthy except for a diagnosis of GERD by their pediatrician , and with a score of at least 16 on the Infant Gastroesophageal Reflux Questionnaire-Revised ( I-GERQ-R ) .
-METHODS	Infants were randomized to receive either MT or a nonmassage sham treatment in their homes for 30 min twice a week for 6 weeks .
-METHODS	Data collectors and parents were blind to study condition .
-RESULTS	GERD symptoms decreased in both groups and weight increased .
-RESULTS	Pretreatment salivary cortisol levels decreased significantly over time in the massage group while increasing in the nonmassage group .
-RESULTS	Daily cortisol level also decreased in the massage group and increased in the nonmassage group , but the difference was not significant .
-CONCLUSIONS	MT administered by a professional therapist did not affect symptoms of GERD differently than a sham treatment but did decrease infant stress as measured by cortisol .
-CONCLUSIONS	Research focusing on stress reduction in infants with GERD and multimodal treatments addressing GERD symptoms may yield the most effective treatment .
-
-###25518175
-OBJECTIVE	Rotation of femoral components could be optimized to improve function and durability of the knee joint .
-OBJECTIVE	The purpose of the present study was to assess rotational alignment of femoral component comparing between CT-based , custom cutting blocks and the contemporary total knee arthroplasty , instrument technique .
-METHODS	The prospective control study of 80 patients underwent total knee arthroplasty by using PFC Sigma PS total knee design .
-METHODS	Rotation offemoral component was analyzed in all patients using postoperative CT scan .
-METHODS	Forty patients were perfonned on by using CT-based , patient-specific cutting blocks with femoral rotational axis relative to transepicondylar axis while forty patients were performed on by using contemporaly instrumentation with alignment at 3 degrees external rotation from posterior condylar line .
-METHODS	The rotation of the femoral component with external rotation ofmore than 3 degrees or internal rotation was considered outlier .
-RESULTS	There was no statistically significant difference among ages , gender ; BMI , pre-operative mechanical axis between the two groups .
-RESULTS	There were eleven outliers in conventional group ( range , 5 degrees ofexternal rotation to 3 degrees of internal rotation ) , three femoral components were in excessive external rotation with the angle of more than 3 degrees and eight femnoral components were in internal rotation .
-RESULTS	In contrast with custom cutting block group was no outliers offemoral rotation .
-RESULTS	The average rotational alignment was 1.040 + / - 0.62 external rotation from epicondylar axis in custom cutting group and 1.58 + / - 1.750 in contemporary group .
-CONCLUSIONS	Custom cutting , block technique significantly reduced the outlier of the femoral component rotation and aided in positioning of the femoral component in optimal alignment .
-CONCLUSIONS	The improvement of femoral rotation showed no difference in clinical outcome between the two groups .
-
-###25068233
-OBJECTIVE	The purpose of the study was to analyze the potential capacity of a dietary supplement , based on gamma linolenic acid , vitamin E , vitamin C , beta-carotene , coenzyme Q10 and Vitis Vitifera , to reduce side effects , in particular the dry skin , erythema and desquamation , due to treatment with oral isotretinoin , and evaluate the ability of the product to increase adherence to therapy in patients with acne .
-METHODS	Forty-eight patients with nodular acne ( 32 females and 16 males ) were randomly divided into 2 groups : 24 received isotretinoin therapy ( 20-30 mg/day ) for 6 months associated to dietary supplement ( twice a day ) , while the other 24 patients received only isotretinoin ( 20-30 mg/day ) for 6 months .
-METHODS	For all patients the degree of acne severity , through GAGS ( Global Acne Grading System ) , the sebum production by Sebutape , the hydration by Corneometer and the erythema by Mexameter , were measured .
-METHODS	We have also evaluated the adherence to treatment , asking to patients how many days a week they follow the therapy .
-RESULTS	Patients treated with dietary supplement had lower side effects , with a less degree of erythema and dryness , and greater degree of hydration ; a greater adherence to therapy was also reported .
-CONCLUSIONS	Thanks to antioxidant and moisturizing properties , the dietary supplement containing gamma linolenic acid , vitamin E , vitamin C , betacarotene , coenzyme Q10 and Vitis Vitifera , can be considered a useful supplement in the treatment and prevention of dry skin associated with the use of oral isotretinoin .
-
-###25967269
-BACKGROUND	Integrating antenatal care ( ANC ) and HIV care may improve uptake and retention in services along the prevention of mother-to-child transmission ( PMTCT ) cascade .
-BACKGROUND	This study aimed to determine whether integration of HIV services into ANC settings improves PMTCT service utilization outcomes .
-METHODS	ANC clinics in rural Kenya were randomized to integrated ( 6 clinics , 569 women ) or nonintegrated ( 6 clinics , 603 women ) services .
-METHODS	Intervention clinics provided all HIV services , including highly active antiretroviral therapy ( HAART ) , whereas control clinics provided PMTCT services but referred women to HIV care clinics within the same facility .
-METHODS	PMTCT utilization outcomes among HIV-infected women ( maternal HIV care enrollment , HAART initiation , and 3-month infant HIV testing uptake ) were compared using generalized estimating equations and Cox regression .
-RESULTS	HIV care enrollment was higher in intervention compared with control clinics [ 69 % versus 36 % ; odds ratio = 3.94 , 95 % confidence interval ( CI ) : 1.14 to 13.63 ] .
-RESULTS	Median time to enrollment was significantly shorter among intervention arm women ( 0 versus 8 days , hazard ratio = 2.20 , 95 % CI : 1.62 to 3.01 ) .
-RESULTS	Eligible women in the intervention arm were more likely to initiate HAART ( 40 % versus 17 % ; odds ratio = 3.22 , 95 % CI : 1.81 to 5.72 ) .
-RESULTS	Infant testing was more common in the intervention arm ( 25 % versus 18 % ) , however , not statistically different .
-RESULTS	No significant differences were detected in postnatal service uptake or maternal retention .
-CONCLUSIONS	Service integration increased maternal HIV care enrollment and HAART uptake .
-CONCLUSIONS	However , PMTCT utilization outcomes were still suboptimal , and postnatal service utilization remained poor in both study arms .
-CONCLUSIONS	Further improvements in the PMTCT cascade will require additional research and interventions .
-
-###24512252
-BACKGROUND	The use of 17-alpha-hydroxyprogesterone caproate ( 17P ) has been shown to reduce preterm delivery in women who have had a prior preterm birth .
-BACKGROUND	The role of 17P in women with arrested preterm labor is less certain .
-OBJECTIVE	To compare the preterm birth rate and neonatal outcome in women with arrested preterm labor randomized to receive 17P or placebo .
-METHODS	Women with arrested preterm labor were randomized to weekly injections of either 17P ( 250mg ) or placebo .
-METHODS	Maternal and neonatal outcome were evaluated .
-RESULTS	Forty-five singleton pregnancies were randomized after successful tocolysis ; 22 received 17P while 23 got placebo .
-RESULTS	Gestational age at delivery ( p = 0.067 ) and the interval from treatment to delivery ( p = 0.233 ) were not affected by 17P .
-RESULTS	Significantly less women in the 17P group delivered at < 34 weeks ( 14 versus 21 , p = 0.035 ) .
-RESULTS	There was also a significant reduction in the risk of neonatal sepsis ( p = 0.047 ) and gr III/IV intraventricular hemorrhage ( IVH ) ( p = 0.022 ) in the 17P group .
-CONCLUSIONS	In this study , 17P did not delay the interval to delivery after successful preterm labor , but births < 34 weeks as well as neonatal sepsis and IVH were reduced by 17P treatment .
-
-###24909625
-CONCLUSIONS	Responses with greater amplitude were recorded when carrier frequencies were modulated at 37 , 40 , and 43 Hz .
-CONCLUSIONS	These responses can be recorded even in patients with significant sensorineural hearing loss , from the sternocleidomastoid ( SCM ) muscle for a 500 Hz tone , 100 % modulated at 40 Hz .
-OBJECTIVE	To determine the best carrier and modulating frequencies to evoke steady-state myogenic responses .
-METHODS	The present study investigated 156 ears of 78 normal-hearing young adults , with carrier frequencies of 250 , 500 , and 1000 Hz , modulated at 20 , 37 , 40 , 43 , 70 , 77 , and 80 Hz , with an intensity of 95 dBA .
-METHODS	Furthermore , we observed responses evoked by stimulus carrier frequency of 500 Hz , modulated at 40 Hz , with an intensity of 95 dBA in a group of five subjects with severe sensorineural loss .
-RESULTS	Responses were found for all stimuli studied ( p < 0.01 ) .
-RESULTS	Modulated stimuli at frequencies of 37 , 40 , and 43 Hz evoked better steady-state vestibular evoked myogenic potential ( S-VEMP ) ( p < 0.05 ) .
-RESULTS	No statistically significant differences were found between the group of normal hearers and the group of subjects with hearing loss ( p = 0.431 ) , for the stimulus used .
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-###25198235
-OBJECTIVE	To examine the effects of a ten week deadlift training program on peak torque and agonist-antagonist coactivation .
-METHODS	Fifty-four untrained subjects ( mean age = 23 years ) participated in this investigation , and were randomly assigned to a training ( males , n = 17 ; females , n = 17 ) or control ( males , n = 9 ; females , n = 11 ) group .
-METHODS	The subjects in the training group performed deadlifts twice per week .
-METHODS	Isometric peak torque for the leg extensors and flexors and surface electromyographic ( EMG ) amplitude for the superficial quadriceps and biceps femoris muscles were assessed .
-RESULTS	Deadlift training increased leg extension peak torque for the males ( P = .008 , Cohen 's d = 0.43 ) and females ( P = .003 , d = 0.48 ) .
-RESULTS	Leg flexion peak torque improved for the females ( P = .001 , d = 0.45 ) .
-RESULTS	Increased EMG amplitude for the superficial quadriceps femoris muscles when they served as agonists was demonstrated for the females ( P = .010 , d = 0.40 ) , but not the males ( P = .059 , d = 0.20 ) .
-RESULTS	For both sexes , the effect sizes for the decline in biceps femoris coactivation were large .
-CONCLUSIONS	Deadlift training elicited improvements in strength and agonist-antagonist coactivation in untrained subjects , and particularly , novice females .
-
-###24762108
-OBJECTIVE	Kisspeptin-54 , an endogenous naturally occurring ligand of the G protein-coupled receptor-54 , stimulates GnRH-gonadotropin secretion and suppresses metastases in animal models of cancer but is subject to rapid degradation and inactivation .
-OBJECTIVE	TAK-448 is an investigational oligopeptide analog of the fully active 10-amino acid C terminus of kisspeptin-54 .
-OBJECTIVE	This phase 1 study evaluated the safety , pharmacokinetics , and pharmacodynamics of TAK-448 in healthy subjects and patients with prostate cancer ( PC ) .
-METHODS	Healthy subjects aged 50 years or older received TAK-448 sc as a single-bolus or 2-hour infusion ( 0.01-6 mg/d ; part A ) and as a 14-day sc administration ( 0.01-1 mg/d ; part B ) .
-METHODS	In a subsequent , open-label , phase 1 study in PC patients aged 40-78 years , TAK-448 was given as a 1-month depot formulation .
-RESULTS	Eighty-two healthy subjects received TAK-448 ; 30 received placebo .
-RESULTS	Grades 1-2 adverse events were reported in 26 % of subjects during TAK-448 treatment .
-RESULTS	All dosing regimens resulted in dose-proportional exposures .
-RESULTS	The maximum observed plasma concentration occurred after 0.25-0 .5 hours , and median terminal elimination half-life was 1.4-5 .3 hours .
-RESULTS	T increased approximately 1.3 - to 2-fold by 48 hours after a single bolus or 2 hour injections , whereas during the 14-day infusion , at doses above 0.1 mg/d , T dropped to below-baseline values by 60 hours and reached a subsequently sustained below-castration level by day 8 .
-RESULTS	In PC patients , T decreased to less than 20 ng/dL in four of five patients dosed with 12 or 24 mg TAK-448 sc-depot injections .
-RESULTS	The prostate-specific antigen decreased greater than 50 % in all patients dosed with 24 mg .
-CONCLUSIONS	Continuous TAK-448 infusion was well tolerated by healthy males and resulted in sustained T suppression .
-CONCLUSIONS	Depot injection in patients with PC similarly reduced T and resulted in prostate-specific antigen responses .
-
-###24786613
-OBJECTIVE	To evaluate the clinical efficacy , safety , and costs of percutaneous occlusive balloon catheter-assisted ureteroscopic lithotripsy ( POBC-URSL ) for large impacted proximal ureteral calculi .
-METHODS	156 patients with impacted proximal ureteral stones 1.5 cm in size were randomized to ureteroscopic lithotripsy ( URSL ) , POBC-URSL , and percutaneous nephrolithotomy ( PNL ) group between May 2010 and May 2013 .
-METHODS	For URSL , the calculi were disintegrated with the assistance of anti-retropulsion devices .
-METHODS	POBC-URSL was performed with the assistance of an 8F percutaneous occlusive balloon catheter .
-METHODS	PNL was finished with the combination of an ultrasonic and a pneumatic lithotripter .
-METHODS	A flexible ureteroscope and a 200m laser fiber were used to achieve stone-free status to a large extent for each group .
-METHODS	Variables studied were mean operative time , auxiliary procedure , postoperative hospital stay , operation-related complications , stone clearance rate , and treatment costs .
-RESULTS	The mean lithotripsy time for POBC-URSL was shorter than URSL , but longer than PNL ( 42.68.9 minutes vs 66.715.3 minutes vs 28.16.3 minutes , p = 0.014 ) .
-RESULTS	The auxiliary procedure rate and postoperative fever rate for POBC-URSL were significantly lower than URSL and comparable to PNL ( p < 0.01 , p = 0.034 ) .
-RESULTS	POBC-URSL was superior to URSL with regard to the stone clearance rate at 3 days postoperatively , and as good as PNL ( 98.1 % vs 75.0 % vs 96.2 % , p < 0.01 ) .
-RESULTS	The postoperative hospital stay and hematuria rate were lower in POBC-URSL group than PNL group and similar to URSL group ( p = 0.016 , p < 0.01 ) .
-RESULTS	The treatment costs were lowest in POBC-URSL group ( $ 1205.0 $ 113.9 vs $ 1731.7 $ 208.1 vs $ 2446.4 $ 166.4 , p = 0.004 ) .
-CONCLUSIONS	For large impacted proximal ureteral calculi , POBC-URSL was associated with a higher stone clearance rate , fewer complications and costs .
-CONCLUSIONS	POBC-URSL combined the advantages of URSL and PNL .
-
-###25600444
-OBJECTIVE	To evaluate the effect of vaginal misoprostol on intraoperative bleeding during myomectomy .
-METHODS	In this randomized clinical trial , 80 women with myomas were randomly assigned to receive 200 g misoprostol or placebo ( vitamin B6 ) 3 h before surgery .
-METHODS	Blood loss during surgery , postoperative need for blood transfusion , and the hemoglobin level before surgery , and 6 and 12 h after surgery were assessed in two groups .
-RESULTS	Mean age and the mean preoperative and postoperative Hb levels were not significantly different between the two groups .
-RESULTS	Mean duration of surgery and mean estimated blood loss were significantly higher in control group .
-RESULTS	Nine ( 22.5 % ) patients in control group needed blood transfusion while there was no need blood transfusion in misoprostol group ( p = 0.001 ) .
-CONCLUSIONS	A single dose of vaginal misoprostol is effective in reducing hemorrhage during myomectomy .
-
-###25374216
-BACKGROUND	Hepatitis C virus ( HCV ) infection is an important cause of liver cancer in Thailand .
-BACKGROUND	The highest prevalence of anti-HCV positive among Thai blood donors is found in the northeastern region .
-BACKGROUND	The present analysis of the genotype distribution among anti-HCV positive northeastern-Thai blood donors was conducted to provide a base for the epidemiological pattern of HCV infection in this region .
-METHODS	A total of 112 HCV seropositive healthy blood donors were randomly selected and tested for the presence of HCV-RNA by RT-PCR .
-METHODS	HCV-RNA positive samples were genotyped by direct sequencing at core region genomes and confirmed by phylogenetic analysis .
-RESULTS	HCV viremia was found in 94.6 % ( 106/112 ) of HCV seropositive blood donors .
-RESULTS	There were 3 major genotypes distributed among this population .
-RESULTS	HCV genotype 3a was the most prevalent ( 71.7 % ) followed by genotypes 1a ( 7.5 % ) , 1b ( 7.5 % ) , 6i ( 3.8 % ) , 6f ( 2.8 % ) and 6n ( 1.9 % ) .
-CONCLUSIONS	HCV genotype 3a in asymptomatic infections in northeastern Thailand is significantly higher than other previous reports .
-CONCLUSIONS	Subgenotype 6 prevalence is less than in neighboring countries and distribution patterns differ .
-CONCLUSIONS	The findings are relevant as predictors for using interferon therapy in this population .
-
-###25329446
-BACKGROUND	Many bacterial pathogens causing respiratory infections in children are common residents of the respiratory tract .
-BACKGROUND	Insight into bacterial colonization patterns and microbiota stability at a young age might elucidate healthy or susceptible conditions for development of respiratory disease .
-OBJECTIVE	To study bacterial succession of the respiratory microbiota in the first 2 years of life and its relation to respiratory health characteristics .
-METHODS	Upper respiratory microbiota profiles of 60 healthy children at the ages of 1.5 , 6 , 12 , and 24 months were characterized by 16S-based pyrosequencing .
-METHODS	We determined consecutive microbiota profiles by machine-learning algorithms and validated the findings cross-sectionally in an additional cohort of 140 children per age group .
-RESULTS	Overall , we identified eight distinct microbiota profiles in the upper respiratory tract of healthy infants .
-RESULTS	Profiles could already be identified at 1.5 months of age and were associated with microbiota stability and change over the first 2 years of life .
-RESULTS	More stable patterns were marked by early presence and high abundance of Moraxella and Corynebacterium/Dolosigranulum and were positively associated with breastfeeding in the first period of life and with lower rates of parental-reported respiratory infections in the consecutive periods .
-RESULTS	Less stable profiles were marked by high abundance of Haemophilus or Streptococcus .
-CONCLUSIONS	These findings provide novel insights into microbial succession in the respiratory tract in infancy and link early-life profiles to microbiota stability and respiratory health characteristics .
-CONCLUSIONS	New prospective studies should elucidate potential implications of our findings for early diagnosis and prevention of respiratory infections .
-CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT00189020 ) .
-
-###24843962
-OBJECTIVE	To compare the difference in the efficacy on gait time cycle of ischemic stroke between yin-yang respiratory reinforcing and reducing needling technique ( yin-yang needling ) and the conventional acupuncture .
-METHODS	Sixty cases of ischemic stroke were randomized into a conventional acupuncture group and a yin-yang needling group , 30 cases in each one .
-METHODS	The basic treatment ( the control of blood pressure , blood sugar and blood lipid , the intravenous drops of ginkgo leaf extract and dipyridamole injection and vinpocetine injection ) were applied in the two groups .
-METHODS	Additionally , in the conventional acupuncture group , the acupoints of the Stomach Meridian of Foot-Yangming [ Biguan ( ST 31 ) , Liangqiu ( ST 34 ) , Zusanli ( ST 36 ) , Shangjuxu ( ST 37 ) , Xiajuxu ( ST 39 ) , etc. ] were selected and stimulated with the even needling technique .
-METHODS	In the yin-yang needling group , the acupoints of yin meridians such as Zuwuli ( LR 10 ) , Xuehai ( SP 10 ) , Yinlingquan ( SP 9 ) and Sanyinjiao ( SP 6 ) , etc. and the acupoints of yang meridians such as Biguan ( ST 31 ) , Liangqiu ( ST 34 ) and Yanglingquan ( GB 34 ) , etc. were selected .
-METHODS	The reducing manipulation of respiratory reinforcing and reducing technique was applied to the acupoints of yin meridians and the reinforcing manipulation was applied to the acupoints of yang meridians .
-METHODS	The kinematics time parameters were determined and compared before and 4 weeks after treatment .
-RESULTS	After treatment , the differences in the gait cycle , the phase time of standing ( % ) , the phase time of single support ( % ) , the phase time of unilateral sway ( % ) on the affected ( healthy ) foot and phase time of double support ( % ) were significant as compared with those before treatment in the patients of the two groups ( all P < 0.05 ) , in which , the gait cycle ( 1.75 + / - 0.21 vs 2.02 + / - 0.37 ) , the phase time of standing ( % ) on the affected ( healthy ) foot [ ( 65.41 + / - 5.20 ) % vs ( 68.37 + / - 6.24 ) % , ( 70.99 + / - 6.47 ) % vs ( 74.51 + / - 5.19 ) % ] , the phase time of unilateral sway ( % ) on the affected ( healthy ) foot [ ( 36.08 + / - 4.86 ) % vs ( 33.65 + / - 2.94 ) % , ( 31.04 + / - 3.41 ) % vs ( 26.77 + / - 2.67 ) % ] and the phase time of double support ( % ) [ ( 36.91 + / - 5.10 ) % vs ( 41.22 + / - 5.39 ) % ] in the yin-yang needling group were improved much obviously after treatment as compared with those in the conventional acupuncture group .
-RESULTS	The differences in support phase time ( % ) , single support phase time ( % ) and sway phase time ( % ) were significant between the affected limb and healthy limb of the two groups after treatment ( all P < 0.05 ) .
-CONCLUSIONS	Yin-yang respiratory reinforcing and reducing needling technique effectively improves hemiplegic gait movement cycle and walking function in patients of ischemic stroke , which is superior to the conventional acupuncture treatment .
-
-###25029875
-OBJECTIVE	Biofeedback is a self-regulation therapy by which the patient learns how to optimize the functioning of his autonomic nervous system .
-OBJECTIVE	It has been applied to patients with various cardiovascular disorders .
-OBJECTIVE	The purpose of this study was to investigate the practical feasibility and the psychophysiological effects of biofeedback applied to heart rate variability ( HRV biofeedback ) in order to increase cardiac coherence in coronary artery disease ( CAD ) patients participating in a cardiac rehabilitation programme .
-RESULTS	In this randomised and controlled study , 31 CAD patients were randomly assigned to an experimental or to a control group .
-RESULTS	The experimental group participated in a programme of 10 sessions of cardiac coherence biofeedback training , in addition to the rehabilitation programme .
-RESULTS	The control group participated in the usual cardiac rehabilitation programme only .
-RESULTS	Physiological variables ( systolic and diastolic blood pressure , SDNN ) and psychosocial variables ( anxiety , depression , type D personality ) were measured at the start and at the end of the programme in both groups .
-RESULTS	Statistical comparisons assessed the inter and intra group differences .
-RESULTS	The small sample size precludes any firm conclusions concerning the effect of cardiac coherence biofeedback on physiological or psychological variables .
-RESULTS	However , we observed a significant increase of the percentage of cardiac coherence , in relation with an increased SDNN index .
-CONCLUSIONS	Our study demonstrated the practical feasibility of cardiac coherence biofeedback training in CAD patients .
-CONCLUSIONS	Further research is desirable to investigate the potential benefit of cardiac coherence biofeedback as an adjunct to stress management in cardiac rehabilitation .
-
-###24885032
-BACKGROUND	Each year approximately 3000 patients in the United Kingdom undergo surgery for esophagogastric cancer .
-BACKGROUND	Jejunostomy feeding tubes , placed at the time of surgery for early postoperative nutrition , have been shown to have a positive impact on clinical outcomes in the short term .
-BACKGROUND	Whether feeding out of hospital is of benefit is unknown .
-BACKGROUND	Local experience has identified that between 15 and 20 % of patients required ` rescue ' jejunostomy feeding for nutritional problems and weight loss while at home .
-BACKGROUND	This weight loss and poor nutrition may contribute to the detrimental effect on the overall quality of life ( QoL ) reported in these patients .
-METHODS	This randomized pilot and feasibility study will provide preliminary information on the routine use of jejunostomy feeding after hospital discharge in terms of clinical benefits and QoL .
-METHODS	Sixty participants undergoing esophagectomy or total gastrectomy will be randomized to receive either a planned program of six weeks of home jejunostomy feeding after discharge from hospital ( intervention ) or treatment-as-usual ( control ) .
-METHODS	The intention of this study is to inform a multi-centre randomized controlled trial .
-METHODS	The primary outcome measures will be recruitment and retention rates at six weeks and six months .
-METHODS	Secondary outcome measures will include disease specific and general QoL measures , nutritional parameters , total and oral nutritional intake , hospital readmission rates , and estimates of healthcare costs .
-METHODS	Up to 20 participants will also be enrolled in a qualitative sub-study that will explore participants ' and carers ' experiences of home tube feeding.The results will be disseminated by presentation at surgical , gastroenterological and dietetic meetings and publication in appropriate peer review journals .
-METHODS	A patient-friendly lay summary will be made available on the University of Leicester and the University Hospitals of Leicester NHS Trust websites .
-METHODS	The study has full ethical and institutional approval and started recruitment in July 2012 .
-BACKGROUND	UKClinical Research Network ID # 12447 ( Main study ) ; UKCRN ID # 13361 ( Qualitative sub study ) ; ClinicalTrials.gov #NCT 01870817 ( First registered 28 May 2013 ) .
-
-###24615211
-OBJECTIVE	To investigate whether the neural representations underlying alternating two acupoint combinations ( ACs ) are the same or not .
-METHODS	In this functional magnetic resonance imaging study , two sets of analgesia ACs were utilized , including Waiguan ( TE5 ) and Qiuxu ( GB40 ) for Group A , and Neiguan ( PC6 ) and Taichong ( LR3 ) for Group B , which are the most commonly adopted in clinical treatment .
-METHODS	Each group had 20 healthy subjects .
-METHODS	An experimental design was proposed , which consisted of a pre-needling resting phase , a needling phase and a post-needling resting phase .
-METHODS	This paradigm optimally mimics the clinical protocol as well as focuses on both the stimulation and the resting periods .
-METHODS	The results were subjected to general linear model analysis , conjunction analysis and the functional connectivity analysis .
-RESULTS	The rostral anterior cingulated cortex was engaged in the initiative period of the acupuncture effect in both groups , and it was chosen as the seed region for the functional connectivity analysis for the following resting period .
-RESULTS	The results showed that several shared brain regions were involved in both groups , in particular the insula , amygdala and hypothalamus .
-RESULTS	Moreover , significant differences were located at the posterior cingulated cortex as revealed by a two sample - test ( P < 0.05 , corrected ) .
-RESULTS	Other regions showed no significant differences .
-RESULTS	This finding was further supported by the spatial correlation analysis that the two groups were significantly correlated ( r = 0.51 , P < 0.01 ) .
-CONCLUSIONS	This preliminary research helps us understand the neurophysiological mechanisms of acupuncture when following clinical guidelines on ACs , as well as provides an important opportunity to develop better treatment strategies for reducing , or even preventing pain .
-
-###24502822
-OBJECTIVE	To assess whether a dementia care coordination intervention delays time to transition from home and reduces unmet needs in elders with memory disorders .
-METHODS	18-month randomized controlled trial of 303 community-living elders .
-METHODS	28 postal code areas of Baltimore , MD. .
-METHODS	Age 70 + years , with a cognitive disorder , community-living , English-speaking , and having a study partner available .
-METHODS	18-month care coordination intervention to systematically identify and address dementia-related care needs through individualized care planning ; referral and linkage to services ; provision of dementia education and skill-building strategies ; and care monitoring by an interdisciplinary team .
-METHODS	Primary outcomes were time to transfer from home and total percent of unmet care needs at 18months .
-RESULTS	Intervention participants had a significant delay in time to all-cause transition from home and the adjusted hazard of leaving the home was decreased by 37 % ( Hazard ratio : 0.63 , 95 % Confidence Interval : 0.42-0 .94 ) compared with control participants .
-RESULTS	Although there was no significant group difference in reduction of total percent of unmet needs from baseline to 18 months , the intervention group had significant reductions in the proportion of unmet needs in safety and legal/advance care domains relative to controls .
-RESULTS	Intervention participants had a significant improvement in self-reported quality of life ( QOL ) relative to control participants .
-RESULTS	No group differences were found in proxy-rated QOL , neuropsychiatric symptoms , or depression .
-CONCLUSIONS	A home-based dementia care coordination intervention delivered by non-clinical community workers trained and overseen by geriatric clinicians led to delays in transition from home , reduced unmet needs , and improved self-reported QOL .
-
-###24734247
-OBJECTIVE	This study investigated long-term effects and implementation processes of workplace strength training for musculoskeletal disorders .
-METHODS	333 and 140 laboratory technicians from private and public sector companies , respectively , replied to a 3-year follow-up questionnaire subsequent to a 1-year randomized controlled trial ( RCT ) with high-intensity strength training for prevention and treatment of neck , shoulder , and arm pain .
-METHODS	Being a natural experiment , the two participating companies implemented and modified the initial training program in different ways during the subsequent 2 years after the RCT .
-RESULTS	At 3-year follow-up the pain reduction in neck , shoulder , elbow , and wrist achieved during the first year was largely maintained at both companies .
-RESULTS	However , the private sector company was rated significantly better than the public sector company in ( 1 ) training adherence , ( 2 ) training culture , that is , relatively more employees trained at the workplace and with colleagues , ( 3 ) self-reported health changes , and ( 4 ) prevention of neck and wrist pain development among initially pain-free employees .
-CONCLUSIONS	This natural experiment shows that strength training can be implemented successfully at different companies during working hours on a long-term basis with lasting effects on pain in neck , shoulder , and arm .
-
-###24784698
-BACKGROUND	This double-blind , randomized controlled trial aimed to investigate inhaled budesonide and oral dexamethasone compared with placebo for their prophylactic efficacy against acute mountain sickness after acute high-altitude exposure .
-METHODS	There were 138 healthy young male lowland residents recruited and randomly assigned to receive inhaled budesonide ( 200 g , twice a day [ bid ] ) , oral dexamethasone ( 4 mg , bid ) , or placebo ( 46 in each group ) .
-METHODS	They traveled to 3900 m altitude from 400 m by car .
-METHODS	Medication started 1 day before high-altitude exposure and continued until the third day of exposure .
-METHODS	Primary outcome measure was the incidence of acute mountain sickness after exposure .
-RESULTS	One hundred twenty-four subjects completed the study ( 42 , 39 , and 43 in the budesonide , dexamethasone , and placebo groups , respectively ) .
-RESULTS	Demographic characteristics were comparable among the 3 groups .
-RESULTS	After high-altitude exposure , significantly fewer participants in the budesonide ( 23.81 % ) and dexamethasone ( 30.77 % ) groups developed acute mountain sickness compared with participants receiving placebo ( 60.46 % ) ( P = .0006 and P = .0071 , respectively ) .
-RESULTS	Both the budesonide and dexamethasone groups had lower heart rate and higher pulse oxygen saturation ( SpO2 ) than the placebo group at altitude .
-RESULTS	Only the budesonide group demonstrated less deterioration in forced vital capacity and sleep quality than the placebo group .
-RESULTS	Four subjects in the dexamethasone group reported adverse reactions .
-CONCLUSIONS	Both inhaled budesonide ( 200 g , bid ) and oral dexamethasone ( 4 mg , bid ) were effective for the prevention of acute mountain sickness , especially its severe form , compared with placebo .
-CONCLUSIONS	Budesonide caused fewer adverse reactions than dexamethasone .
-
-###24856229
-OBJECTIVE	To evaluate heart rate variability ( HRV ) , hemodynamics , mechanics , dyspnea and blood gases following different mechanical ventilation ( MV ) settings .
-BACKGROUND	No study has evaluated physiological changes during T-piece trials following different MV settings .
-METHODS	In 8 COPD patients on prolonged MV we applied in random order two MV settings : i ) pressure support ( PS ) 20 cm H2O + positive end-expiratory pressure ( PEEP ) 0 cm H2O ( setting-1 ) and ii ) PS 15 cm H2O + PEEP 5 cm H2O ( setting-2 ) , each followed by a 30 min T-piece trial .
-RESULTS	Setting-1 induced greater minute ventilation , tidal volume/inspiratory time and lower pulmonary artery occlusion pressure ; setting-2 reduced intrinsic PEEP .
-RESULTS	Mechanics and hemodynamics data did not differ , but all HRV time domain indices were reduced only after setting-1 , suggesting a decreased parasympathetic and increased sympathetic cardiac modulation .
-CONCLUSIONS	The T-piece trial following setting-2 seems less stressful on neural control of HRV .
-CONCLUSIONS	Future studies on T-piece trials should consider the residual effect of the MV setting .
-
-###25213578
-BACKGROUND	There is a gap in the literature regarding learning outcomes linked to the use of high-fidelity simulators compared to that of traditional teaching methods .
-OBJECTIVE	To examine the effect of using high-fidelity simulators on knowledge and skills acquisition and retention with university students .
-METHODS	A randomized two-arm trial using two different educational approaches on 90 nursing students assigned randomly to two groups was used at two points of time .
-RESULTS	The results showed significant differences in favor of the participants in the high-fidelity simulator group on both the acquisition and retention of knowledge and skills over time .
-RESULTS	However , a significant loss of cardiopulmonary resuscitation knowledge and skills occurred at 3 months after training in both groups .
-CONCLUSIONS	The findings of this study may assist educators in integrating high-fidelity simulators in education and training .
-CONCLUSIONS	In addition , the findings may help nursing educators to arrange additional cardiopulmonary resuscitation training sessions in order to improve cardiac arrested patients ' outcomes .
-CONCLUSIONS	High-fidelity simulation ( HFS ) provides students with interactive learning experiences in a safe controlled environment .
-CONCLUSIONS	HFS enables teachers to implement critical clinical scenarios , such as cardiac arrest , without risk to patients .
-CONCLUSIONS	Integrating the simulation training into nursing curricula will help to overcome the challenges that face many courses , specifically the shortage of clinical areas for training and the increase in numbers of nursing students .
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-###25048383
-OBJECTIVE	To evaluate weekly subcutaneous albiglutide versus daily sitagliptin in renally impaired patients with type 2 diabetes and inadequately controlled glycemia on a regimen of diet and exercise and/or oral antihyperglycemic medications .
-METHODS	In this phase III , randomized , double-blind , multicenter , 52-week study , the primary study end point was HbA1c change from baseline at week 26 in patients with renal impairment , as assessed with estimated glomerular filtration rate and categorized as mild , moderate , or severe ( 60 to 89 , 30 to 59 , and 15 to 29 mL/min/1 .73 m ( 2 ) , respectively ) .
-METHODS	Secondary end points included fasting plasma glucose ( FPG ) , weight , achievement of treatment targets , hyperglycemic rescue , and safety .
-RESULTS	Baseline demographics were similar across treatment and renal impairment groups with overall mean age of 63.3 years , BMI of 30.4 kg/m ( 2 ) , HbA1c of 8.2 % ( 66 mmol/mol ) , and diabetes disease duration of 11.2 years .
-RESULTS	HbA1c change from baseline at week 26 was significantly greater for albiglutide than sitagliptin ( -0.83 % vs. -0.52 % , P = 0.0003 ) .
-RESULTS	Decreases in HbA1c , FPG , and weight were seen through week 52 .
-RESULTS	Time to hyperglycemic rescue through week 52 was significantly longer for albiglutide than sitagliptin ( P = 0.0017 ) .
-RESULTS	Results of safety assessments were similar between groups , and most adverse events ( AEs ) were mild or moderate .
-RESULTS	The incidences of gastrointestinal AEs for albiglutide and sitagliptin were as follows : overall , 31.7 % , 25.2 % ; diarrhea , 10.0 % , 6.5 % ; nausea , 4.8 % , 3.3 % ; and vomiting , 1.6 % , 1.2 % , respectively .
-CONCLUSIONS	Once-weekly albiglutide therapy in renally impaired patients with type 2 diabetes provided statistically superior glycemic improvement with almost similar tolerability compared with daily sitagliptin therapy .
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-###25014057
-BACKGROUND	Antihypertensive drugs are used to control blood pressure ( BP ) and reduce macro - and microvascular complications in hypertensive patients with diabetes .
-OBJECTIVE	The present study aimed to compare the functional vascular changes in hypertensive patients with type 2 diabetes mellitus after 6 weeks of treatment with amlodipine or losartan .
-METHODS	Patients with a previous diagnosis of hypertension and type 2 diabetes mellitus were randomly divided into 2 groups and evaluated after 6 weeks of treatment with amlodipine ( 5 mg/day ) or losartan ( 100 mg/day ) .
-METHODS	Patient evaluation included BP measurement , ambulatory BP monitoring , and assessment of vascular parameters using applanation tonometry , pulse wave velocity ( PWV ) , and flow-mediated dilation ( FMD ) of the brachial artery .
-RESULTS	A total of 42 patients were evaluated ( 21 in each group ) , with a predominance of women ( 71 % ) in both groups .
-RESULTS	The mean age of the patients in both groups was similar ( amlodipine group : 54.9 4.5 years ; losartan group : 54.0 6.9 years ) , with no significant difference in the mean BP [ amlodipine group : 145 14 mmHg ( systolic ) and 84 8 mmHg ( diastolic ) ; losartan group : 153 19 mmHg ( systolic ) and 90 9 mmHg ( diastolic ) ] .
-RESULTS	The augmentation index ( 30 % 9 % and 36 % 8 % , p = 0.025 ) and augmentation pressure ( 16 6 mmHg and 20 8 mmHg , p = 0.045 ) were lower in the amlodipine group when compared with the losartan group .
-RESULTS	PWV and FMD were similar in both groups .
-CONCLUSIONS	Hypertensive patients with type 2 diabetes mellitus treated with amlodipine exhibited an improved pattern of pulse wave reflection in comparison with those treated with losartan .
-CONCLUSIONS	However , the use of losartan may be associated with independent vascular reactivity to the pressor effect .
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-###25246774
-OBJECTIVE	The objective of the current study was to evaluate the efficacy of aminaphtone to control gum bleeding .
-METHODS	Fifteen male and 15 female children , aged between 10 and 18 years with a mean age of 13.4 years and with gingival bleeding , were enrolled in this randomized , double-blind , placebo-controlled , Phase IV clinical trial .
-METHODS	The inclusion criterion was gingivitis with gingival bleeding .
-METHODS	Participants were prescribed either aminaphtone or placebo .
-METHODS	Thirty identical boxes containing blister packs of identical pills of either aminaphtone or placebo were produced and coded with unique numbers by the manufacturer ( Baldacci Laboratory , Brazil ) and donated for this trial .
-METHODS	A research assistant administered aminaphtone ( Capilarema 75 mg ) to fifteen patients or placebo to fifteen patients twice daily for 5 days .
-METHODS	Intraoral clinical evaluations of bleeding were made before starting medication/placebo and then at 3 and 5 days after administration .
-RESULTS	On comparing the number of bleeding points before and after treatment between the aminaphtone and placebo groups , we found significantly higher reductions with the medication ( P < 0.0001 ) .
-CONCLUSIONS	Aminaphtone reduces gum bleeding in gingivitis , and may have a supportive role in the control of bleeding .
-
-###24876260
-OBJECTIVE	Magnetic resonance perfusion ( MRP ) and computed tomographic perfusion ( CTP ) are being increasingly applied in acute stroke trials and clinical practice , yet the comparability of their perfusion values is not well validated .
-OBJECTIVE	The aim of this study was to validate the comparability of CTP and MRP measures .
-METHODS	A 3-step approach was used .
-METHODS	Step 1 was a derivation step , where we analyzed 45 patients with acute ischemic stroke who had both CTP and MRP performed within 2 hours of each other and within 9 hours of stroke onset .
-METHODS	In this step , we derived the optimal perfusion map with the least difference between MRP and CTP .
-METHODS	In step 2 , the optimal map was validated on whole-brain perfusion data of 15 patients .
-METHODS	Step 3 was to apply the optimal perfusion map to define cross-modality reperfusion from acute CTP to 24-hour MRP in 45 patients and , in turn , to assess how accurately this predicted 3-month clinical outcome .
-RESULTS	Among 8 different perfusion maps included in this study , time to peak of the residual function ( T ( max ) ) was the only one with a nonsignificant difference between CTP and MRP in delineating perfusion defects .
-RESULTS	This was validated on whole-brain perfusion data , showing high concordance of T ( max ) between the 2 modalities ( concordance correlation coefficient of Lin , > 0.91 ) ; the best concordance was at 6 s.
-RESULTS	At T ( max ) > 6 s threshold , MRP and CTP reached substantial agreement in mismatch classification ( > 0.61 ) .
-RESULTS	Cross-modality reperfusion calculated by T ( max ) > 6 s strongly predicted good functional outcome at 3 months ( area under the curve , 0.979 ; P < 0.05 ) .
-CONCLUSIONS	MRP and CTP can be used interchangeably if one uses T ( max ) measurement .
-
-###24693681
-BACKGROUND	Previous studies have demonstrated that oxidative stress by mediating the excessive production of reactive oxygen species is involved in tissue damage and organ failure during and after surgery .
-BACKGROUND	The impact of the preoperative immunonutrition including antioxidants on the postoperative course of patients undergoing hepatic surgery was investigated in this pilot study .
-METHODS	Twenty-three living donor liver transplantation ( LDLT ) donors were randomly assigned to either an experimental ( AO ) group , received a commercial supplement enriched with antioxidant nutrients for each of the 5 days immediately prior to surgery while maintaining normal food intake , or a control ( CT ) group , administered no supplement .
-METHODS	Antioxidative capacity was measured by spectrophotometry of patient serum using a free-radical analytical system .
-RESULTS	The antioxidative capacity of 90.9 % patients in the AO group increased after immunonutrition .
-RESULTS	Compared to the CT group , the AO group was found to have higher antioxidant capacity and transferrin levels ; lower WBC , lymphocyte , and neutrophil counts ; and briefer duration of postoperative fever during the postsurgical period .
-RESULTS	No significant differences were found between the 2 groups regarding the nutritional parameters ; liver functioning parameters ; immunological parameters ; intraoperative factors ; postoperative outcomes .
-CONCLUSIONS	Preoperative immunonutrition including antioxidants might play a beneficial role in improving postsurgical immunological response but the modest biological advantage was not associated with any significant clinical outcome .
-
-###26227188
-BACKGROUND	The RITA-3 ( Third Randomised Intervention Treatment of Angina ) trial compared outcomes of a routine early invasive strategy ( coronary arteriography and myocardial revascularization , as clinically indicated ) to those of a selective invasive strategy ( coronary arteriography for recurrent ischemia only ) in patients with non-ST-segment elevation acute coronary syndrome ( NSTEACS ) .
-BACKGROUND	At a median of 5 years ' follow-up , the routine invasive strategy was associated with a 24 % reduction in the odds of all-cause mortality .
-OBJECTIVE	This study reports 10-year follow-up outcomes of the randomized cohort to determine the impact of a routine invasive strategy on longer-term mortality .
-METHODS	We randomized 1,810 patients with NSTEACS to receive routine invasive or selective invasive strategies .
-METHODS	All randomized patients had annual follow-up visits up to 5 years , and mortality was documented thereafter using data from the Office of National Statistics .
-RESULTS	Over 10 years , there were no differences in mortality between the 2 groups ( all-cause deaths in 225 [ 25.1 % ] vs. 232 patients [ 25.4 % ] : p = 0.94 ; and cardiovascular deaths in 135 [ 15.1 % ] vs. 147 patients [ 16.1 % ] : p = 0.65 in the routine invasive and selective invasive groups , respectively ) .
-RESULTS	Multivariate analysis identified several independent predictors of 10-year mortality : age , previous myocardial infarction , heart failure , smoking status , diabetes , heart rate , and ST-segment depression .
-RESULTS	A modified post-discharge Global Registry of Acute Coronary Events ( GRACE ) score was used to calculate an individual risk score for each patient and to form low-risk , medium-risk , and high-risk groups .
-RESULTS	Risk of death within 10 years varied markedly from 14.4 % in the low-risk group to 56.2 % in the high-risk group .
-RESULTS	This mortality trend did not depend on the assigned treatment strategy .
-CONCLUSIONS	The advantage of reduced mortality of routine early invasive strategy seen at 5 years was attenuated during later follow-up , with no evidence of a difference in outcome at 10 years .
-CONCLUSIONS	Further trials of contemporary intervention strategies in patients with NSTEACS are warranted .
-CONCLUSIONS	( Third Randomised Intervention Treatment of Angina trial [ RITA-3 ] ; ISRCTN07752711 ) .
-
-###24302090
-OBJECTIVE	Communication about end-of-life care is a core clinical skill .
-OBJECTIVE	Simulation-based training improves skill acquisition , but effects on patient-reported outcomes are unknown .
-OBJECTIVE	To assess the effects of a communication skills intervention for internal medicine and nurse practitioner trainees on patient - and family-reported outcomes .
-METHODS	Randomized trial conducted with 391 internal medicine and 81 nurse practitioner trainees between 2007 and 2013 at the University of Washington and Medical University of South Carolina .
-METHODS	Participants were randomized to an 8-session , simulation-based , communication skills intervention ( N = 232 ) or usual education ( N = 240 ) .
-METHODS	Primary outcome was patient-reported quality of communication ( QOC ; mean rating of 17 items rated from 0-10 , with 0 = poor and 10 = perfect ) .
-METHODS	Secondary outcomes were patient-reported quality of end-of-life care ( QEOLC ; mean rating of 26 items rated from 0-10 ) and depressive symptoms ( assessed using the 8-item Personal Health Questionnaire [ PHQ-8 ] ; range , 0-24 , higher scores worse ) and family-reported QOC and QEOLC .
-METHODS	Analyses were clustered by trainee .
-RESULTS	There were 1866 patient ratings ( 44 % response ) and 936 family ratings ( 68 % response ) .
-RESULTS	The intervention was not associated with significant changes in QOC or QEOLC .
-RESULTS	Mean values for postintervention patient QOC and QEOLC were 6.5 ( 95 % CI , 6.2 to 6.8 ) and 8.3 ( 95 % CI , 8.1 to 8.5 ) respectively , compared with 6.3 ( 95 % CI , 6.2 to 6.5 ) and 8.3 ( 95 % CI , 8.1 to 8.4 ) for control conditions .
-RESULTS	After adjustment , comparing intervention with control , there was no significant difference in the QOC score for patients ( difference , 0.4 points [ 95 % CI , -0.1 to 0.9 ] ; P = .15 ) or families ( difference , 0.1 [ 95 % CI , -0.8 to 1.0 ] ; P = .81 ) .
-RESULTS	There was no significant difference in QEOLC score for patients ( difference , 0.3 points [ 95 % CI , -0.3 to 0.8 ] ; P = .34 ) or families ( difference , 0.1 [ 95 % CI , -0.7 to 0.8 ] ; P = .88 ) .
-RESULTS	The intervention was associated with significantly increased depression scores among patients of postintervention trainees ( mean score , 10.0 [ 95 % CI , 9.1 to 10.8 ] , compared with 8.8 [ 95 % CI , 8.4 to 9.2 ] ) for control conditions ; adjusted model showed an intervention effect of 2.2 ( 95 % CI , 0.6 to 3.8 ; P = .006 ) .
-CONCLUSIONS	Among internal medicine and nurse practitioner trainees , simulation-based communication training compared with usual education did not improve quality of communication about end-of-life care or quality of end-of-life care but was associated with a small increase in patients ' depressive symptoms .
-CONCLUSIONS	These findings raise questions about skills transfer from simulation training to actual patient care and the adequacy of communication skills assessment .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00687349 .
-
-###25050589
-OBJECTIVE	NSAIDs , such as diclofenac , are the most commonly used medications to treat osteoarthritis ( OA ) , but they are associated with dose-related adverse events ( AEs ) .
-OBJECTIVE	Low-dose submicron diclofenac was developed using a new , proprietary dry milling process that creates submicron drug particles ( SoluMatrix Fine Particle Technology * ) , enabling effective treatment at lower doses than other commercially available diclofenac drug products .
-OBJECTIVE	This phase 3 study evaluated the efficacy and safety of low-dose submicron diclofenac 35mg three times daily ( tid ) and twice daily ( bid ) in patients with OA pain .
-METHODS	This double-blind study enrolled patients 40 years of age with clinically and radiographically confirmed ( Kellgren-Lawrence grade II-III ) hip or knee OA .
-METHODS	Eligible patients were chronic NSAID and/or acetaminophen ( APAP ) users with baseline Western Ontario and McMasters Universities Osteoarthritis Index ( WOMAC ) pain subscale scores 40mm by visual analog scale and an OA flare ( 15mm increase in WOMAC pain subscale score following discontinuation of NSAIDs/APAP at screening ) .
-METHODS	Patients were randomized to submicron diclofenac 35mg tid , submicron diclofenac 35mg bid , or placebo for 12 weeks .
-METHODS	ClinicalTrials.gov identifier : NCT01461369 .
-METHODS	Efficacy parameters included mean change from baseline in WOMAC pain subscale score at week 12 ( primary efficacy parameter ) and in average total WOMAC score over 12 weeks .
-RESULTS	Submicron diclofenac 35mg tid significantly improved WOMAC pain subscale scores from baseline at 12 weeks ( -44.1 ; p = 0.0024 ) compared with placebo ( -32.5 ) .
-RESULTS	Submicron diclofenac 35mg bid provided numerical improvement in pain at week 12 that did not reach statistical significance ( -39.0 ; p = 0.0795 ) compared with placebo .
-RESULTS	Submicron diclofenac 35mg tid ( -35.9 ; p = 0.0002 ) and 35mg bid ( -30.3 ; p = 0.0363 ) improved the average total WOMAC score in treated patients over 12 weeks compared with placebo ( -23.2 ) .
-RESULTS	The most frequent AEs in the submicron diclofenac-treated groups were diarrhea , headache , nausea , and constipation .
-RESULTS	The inclusion of patients with a documented requirement for analgesic therapy ( OA ` flare ' ) at baseline and the high rates of rescue medication usage in the placebo group may have impacted the study outcome for the submicron diclofenac treatment groups .
-CONCLUSIONS	Low-dose submicron diclofenac is an effective therapeutic option for the treatment of OA pain .
-
-###24684973
-OBJECTIVE	The phase 3 TRANSFORMS and FREEDOMS studies established the efficacy of fingolimod in reducing multiple sclerosis ( MS ) relapses and magnetic resonance imaging lesions compared with intramuscular ( IM ) interferon ( IFN ) -1 a and placebo over 12 and 24 months , respectively .
-METHODS	To investigate the efficacy of fingolimod at the approved 0.5 mg dose in patients early in the MS disease course , post hoc subgroup analyses of TRANSFORMS ( n = 272 ) and FREEDOMS ( n = 217 ) data were conducted in patients who experienced their first MS symptom < 3 years before randomization .
-RESULTS	Fingolimod 0.5 mg reduced annualized relapse rate by 73.4 % ( P = 0.0002 ) versus IFN-1a IM and by 67.4 % ( P < 0.0001 ) versus placebo in patients with < 3 years since first symptom ; respective reductions were 45.4 % and 51.4 % in subgroups of patients with 3 years since first symptom .
-RESULTS	For patients with < 3 years since their first symptom , significantly fewer new/newly enlarged T2 lesions were observed with fingolimod versus IFN-1a IM ( mean number , 1.94 vs. 2.95 ; P = 0.036 ) or placebo ( 4.1 vs. 10.7 ; P < 0.001 ) ; the mean number of gadolinium-enhancing T1 lesions was significantly reduced versus placebo ( 0.3 vs. 1.1 ; P < 0.001 ) .
-CONCLUSIONS	Fingolimod 0.5 mg is highly effective in reducing relapses and MRI activity in patients early in the MS disease course .
-
-###24763755
-OBJECTIVE	Scarring from bacterial keratitis remains a leading cause of visual loss .
-OBJECTIVE	To determine whether topical corticosteroids are beneficial as an adjunctive therapy for bacterial keratitis if given early in the course of infection .
-METHODS	The Steroids for Corneal Ulcers Trial ( SCUT ) was a randomized , double-masked , placebo-controlled trial that overall found no effect of adding topical corticosteroids to topical moxifloxacin hydrochloride in bacterial keratitis .
-METHODS	Here , we assess the timing of administration of corticosteroids in a subgroup analysis of the SCUT .
-METHODS	We define earlier administration of corticosteroids ( vs placebo ) as addition after 2 to 3 days of topical antibiotics and later as addition after 4 or more days of topical antibiotics .
-METHODS	We assess the effect of topical corticosteroids ( vs placebo ) on 3-month best spectacle-corrected visual acuity in patients who received corticosteroids or placebo earlier vs later .
-METHODS	Further analyses were performed for subgroups of patients with non-Nocardia keratitis and those with no topical antibiotic use before enrollment .
-RESULTS	Patients treated with topical corticosteroids as adjunctive therapy within 2 to 3 days of antibiotic therapy had approximately 1-line better visual acuity at 3 months than did those given placebo ( -0.11 logMAR ; 95 % CI , -0.20 to -0.02 logMAR ; P = .01 ) .
-RESULTS	In patients who had 4 or more days of antibiotic therapy before corticosteroid treatment , the effect was not significant ; patients given corticosteroids had 1-line worse visual acuity at 3 months compared with those in the placebo group ( 0.10 logMAR ; 95 % CI , -0.02 to 0.23 logMAR ; P = .14 ) .
-RESULTS	Patients with non-Nocardia keratitis and those having no topical antibiotic use before the SCUT enrollment showed significant improvement in best spectacle-corrected visual acuity at 3 months if corticosteroids were administered earlier rather than later .
-CONCLUSIONS	There may be a benefit with adjunctive topical corticosteroids if application occurs earlier in the course of bacterial corneal ulcers .
-
-###24367678
-OBJECTIVE	We used data from a randomized trial of HIV-tuberculosis co-infected patients in Mozambique to determine the incidence and predictors of paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome ( IRIS ) occurring within 12 weeks of starting antiretroviral therapy , and to evaluate its association with patient outcome at 48 weeks .
-METHODS	HIV-tuberculosis co-infected and antiretroviral therapy-nave adults with less than 250 CD4/mm3 were randomized to a nevirapine or efavirenz-based antiretroviral therapy initiated 4 to 6 weeks after starting tuberculosis treatment , and were then followed for 48 weeks .
-METHODS	Tuberculosis cases were diagnosed using WHO guidelines , and tuberculosis-IRIS by case definitions of the International Network for the Study of HIV-associated IRIS .
-RESULTS	The 573 HIV-tuberculosis co-infected patients who initiated antiretroviral therapy had a median CD4 count of 92 cells/mm ( 3 ) and HIV-1 RNA of 5.6 log10 copies/mL .
-RESULTS	Mortality at week 48 was 6.1 % ( 35/573 ) .
-RESULTS	Fifty-three ( 9.2 % ) patients presented a tuberculosis-IRIS within 12 weeks of starting antiretroviral therapy .
-RESULTS	Being female and having a low CD4 count , high HIV-1 RNA load , low body mass index and smear-positive pulmonary tuberculosis were independently associated with tuberculosis-IRIS .
-RESULTS	After adjustment for baseline body mass index , CD4 count and hemoglobin , occurrence of tuberculosis-IRIS was independently associated with 48-week mortality ( aOR 2.72 95 % CI 1.14-6 .54 ) .
-RESULTS	Immunological and HIV-1 virological responses and tuberculosis treatment outcomes were not different between patients with and without tuberculosis-IRIS .
-CONCLUSIONS	In this large prospective cohort , tuberculosis-IRIS occurrence within 12 weeks of starting antiretroviral therapy was independently associated with the mortality of HIV-tuberculosis co-infected patients at 48 weeks post antiretroviral therapy initiation .
-
-###25214516
-BACKGROUND	Rifaximin , a nonabsorbable antibiotic that decreases lipopolysaccharide ( LPS ) in cirrhotics , may decrease the elevated levels of microbial translocation , T-cell activation and inflammation in human immunodeficiency virus ( HIV ) - positive immune nonresponders to antiretroviral therapy ( ART ) .
-METHODS	HIV-positive adults receiving ART for 96 weeks with undetectable viremia for 48 weeks and CD4 ( + ) T-cell counts < 350 cells/mm ( 3 ) were randomized 2:1 to rifaximin versus no study treatment for 4 weeks .
-METHODS	T-cell activation , LPS , and soluble CD14 were measured at baseline and at weeks 2 , 4 , and 8 .
-METHODS	Wilcoxon rank sum tests compared changes between arms .
-RESULTS	Compared with no study treatment ( n = 22 ) , rifaximin ( n = 43 ) use was associated with a significant difference between study arms in the change from baseline to week 4 for CD8 ( + ) T-cell activation ( median change , 0.0 % with rifaximin vs +0.6 % with no treatment ; P = .03 ) .
-RESULTS	This difference was driven by an increase in the no-study-treatment arm because there was no significant change within the rifaximin arm .
-RESULTS	Similarly , although there were significant differences between study arms in change from baseline to week 2 for LPS and soluble CD14 , there were no significant changes within the rifaximin arm .
-CONCLUSIONS	In immune nonresponders to ART , rifaximin minimally affected microbial translocation and CD8 ( + ) T-cell activation .
-CONCLUSIONS	Trial registration number.NCT01466595 .
-
-###24393747
-BACKGROUND	Canagliflozin , a sodium glucose co-transporter 2 inhibitor , lowers plasma glucose in individuals with hyperglycemia by inhibiting renal glucose reabsorption and increasing glucosuria .
-BACKGROUND	Urinary tract infections ( UTIs ) were characterized in patients with type 2 diabetes mellitus enrolled in Phase III studies of canagliflozin .
-METHODS	Analyses were performed in 2 pooled datasets : Population 1 ( N = 2313 ; mean exposure [ weeks ] : canagliflozin , 24.3 ; placebo , 23.8 ) including patients from 4 placebo-controlled studies ; Population 2 ( N = 9439 ; mean exposure [ weeks ] : canagliflozin , 68.1 ; control , 64.4 ) including patients from 8 placebo - and active-controlled studies ( including patients with renal impairment or high risk of cardiovascular disease , and older patients ) .
-METHODS	Individual studies in special patient populations and 2 active-controlled studies were analyzed separately .
-METHODS	Patients with a prior history of UTIs were not excluded from these studies .
-METHODS	Urinary tract infection frequency and characteristics were systematically collected , with additional information for each event collected using supplemental electronic case report forms .
-RESULTS	In Populations 1 and 2 , canagliflozin 100 and 300 mg were associated with small increases in the incidence of UTIs compared with control , with no dose-dependence .
-RESULTS	Urinary tract infections with canagliflozin were similar to those with control in severity , and upper UTIs were infrequent across groups .
-RESULTS	No increase in serious events or those leading to discontinuation were seen with canagliflozin versus control .
-RESULTS	Time to the first occurrence of symptomatic UTIs tended to be earlier with canagliflozin than placebo in Population 1 , and similar with canagliflozin and control in Population 2 ; median duration of events was similar across groups in both populations .
-RESULTS	The proportion of patients with recurrent events was low across groups .
-CONCLUSIONS	Canagliflozin was associated with a small increase in incidence of UTIs in patients with type 2 diabetes mellitus , with no increase in serious or upper UTIs .
-
-###24571704
-OBJECTIVE	To compare the erosion protection efficacy of a stabilised , stannous fluoride ( SnF2 ) dentifrice versus a sodium fluoride ( NaF ) dentifrice using a modified in situ clinical model .
-METHODS	This study , a randomised parallel group in situ design with in vivo product use and ex vivo acid challenge , compared : A , a dentifrice containing 1,450 ppm F as NaF ; B , a dentifrice containing 1,450 ppm F ( 1,100 ppm F as SnF2 + 350 ppm F as NaF ) ; and T , tap water .
-METHODS	Sample size was n = 4 per group ( total of 12 subjects ) and within each subject appliances were placed on each side of the mouth ( left and right ) .
-METHODS	Enamel specimens were placed in different positions of the mouth ( front , mid-front , mid-rear , rear ) in each appliance ( total = 8 specimens per subject ) .
-METHODS	Product treatment was twice per day ( lingual brushing for 30 seconds followed by swishing for 90 seconds with the resultant product/saliva slurry ) in vivo for 15 days , and ex vivo acid treatment ( 0.02 m citric acid 5 minutes four times per day ; total exposure time = 300 minutes ) .
-METHODS	Data were analysed using a general linear repeated measures model with treatment , side and position as fixed effects .
-METHODS	Within subjects , correlations were modelled assuming a different correlation and variance for treatment B relative to the other groups .
-METHODS	Pairwise treatment differences were performed using a 5 % two-sided significance level .
-RESULTS	Enamel loss ( in m ) was significantly lower ( P < 0.005 ) for treatment B versus treatments A and T. Treatment B reduced enamel surface loss by 86.9 % relative to treatment A.
-RESULTS	There was no statistical difference in mean enamel loss ( P = 0.51 ) between treatments A and T. Enamel loss was not statistically different for side ( left vs. right ; P = 0.44 ) or position ( front , mid-front , mid-rear , rear ; P = 0.36 ) .
-CONCLUSIONS	This modified in situ erosion model confirmed the enhanced erosion protection benefits of a stabilised SnF2 dentifrice versus a conventional NaF dentifrice , validating the ability of the model to safely and effectively demonstrate differences in the erosion protection potential of oral care products .
-
-###24356394
-BACKGROUND	Renin-angiotensin system ( RAS ) inhibition has proven to be helpful in reducing cardiovascular and kidney disease progression in the general population ; whether kidney transplant patients would derive similar benefits is unknown .
-BACKGROUND	RAS inhibition also reduces posttransplantation erythrocytosis in kidney transplant recipients , but its effect on hemoglobin ( Hb ) levels in patients without posttransplantation erythrocytosis is unclear .
-METHODS	The Specific Management of Anemia and Hypertension in Renal Transplant ( SMAhRT ) recipients study was designed to examine the cardiovascular benefits of RAS blockade with telmisartan 80 mg versus placebo , and Hb management with darbepoetin in a randomized , double-blind , single-center controlled trial in 2,000 patients over 3 years .
-METHODS	The primary efficacy variable was a composite of all-cause mortality , myocardial infarction or stroke .
-RESULTS	The SMAhRT study was stopped prematurely due to a lower than expected event rate .
-RESULTS	At that point , 136 patients were enrolled and were followed for a mean duration of 15 months .
-RESULTS	The use of RAS blockade was not associated with an increased risk of adverse events such as worsening anemia or hyperkalemia .
-RESULTS	Likewise , the correction of Hb with darbepoetin was not associated with any increase in thrombotic events .
-CONCLUSIONS	This study provides insight into the safety of RAS inhibition and Hb correction with an erythrocyte-stimulating agent in kidney transplant recipients .
-
-###25311881
-OBJECTIVE	Although many initiatives exist to improve the availability of healthy foods in corner stores , few randomized trials have assessed their effects .
-OBJECTIVE	This study evaluated , in a randomized controlled trial , the effects of a first-generation healthy corner store intervention on students ' food and beverage purchases over a 2-year period .
-METHODS	Participants ( n = 767 ) were fourth - , fifth - , and sixth-grade students .
-METHODS	Ten schools and their nearby corner stores ( n = 24 ) were randomly assigned to the healthy corner store intervention or an assessment-only control .
-METHODS	Intercept surveys directly assessed the nutritional characteristics of students ' corner store purchases at baseline , 1 and 2 years .
-METHODS	Students ' weight and heights were measured at baseline , 1 and 2 years .
-RESULTS	There were no differences in energy content per intercept purchased from control or intervention schools at year 1 ( P = 0.12 ) or 2 ( P = 0.58 ) .
-RESULTS	There were no differences between control and intervention students in BMI z score ( year 1 , P = 0.83 ; year 2 , P = 0.98 ) or obesity prevalence ( year 1 , P = 0.96 ; year 2 , P = 0.58 ) .
-CONCLUSIONS	A healthy corner store initiative did not result in significant changes in the energy content of corner store purchases or in continuous or categorical measures of obesity .
-CONCLUSIONS	These data will help to inform future interventions .
-
-###24625239
-OBJECTIVE	We investigated the effects of dietary intervention with canola or olive oil in comparison with commonly used refined oil in Asian Indians with nonalcoholic fatty liver disease ( NAFLD ) .
-METHODS	This was a 6-month intervention study including 93 males with NAFLD , matched for age and body mass index ( BMI ) .
-METHODS	Subjects were randomized into three groups to receive olive oil ( n = 30 ) , canola oil ( n = 33 ) , and commonly used soyabean/safflower oil ( control ; n = 30 ) as cooking medium ( not exceeding 20 g/day ) along with counseling for therapeutic lifestyle changes .
-METHODS	The BMI , fasting blood glucose ( FBG ) and insulin levels , lipids , homeostasis model of assessment for insulin resistance ( HOMA-IR ) , HOMA denoting - cell function ( HOMA-CF ) , and disposition index ( DI ) were measured at pre - and post-intervention .
-METHODS	Data were analyzed with one-way analysis of variance ( ANOVA ) and Tukey 's Honestly Significant Difference multiple comparison test procedures .
-RESULTS	Olive oil intervention led to a significant decrease in weight and BMI ( ANOVA , P = 0.01 ) compared with the control oil group .
-RESULTS	In a comparison of olive and canola oil , a significant decrease in fasting insulin level , HOMA-IR , HOMA-CF , and DI ( P < 0.001 ) was observed in the olive oil group .
-RESULTS	Pre - and post-intervention analysis revealed a significant increase in high-density lipoprotein level ( P = 0.004 ) in the olive oil group and a significant decrease in FBG ( P = 0.03 ) and triglyceride ( P = 0.02 ) levels in the canola oil group .
-RESULTS	The pre - and post-intervention difference in liver span was significant only in the olive ( 1.14 2 cm ; P < 0.05 ) and canola ( 0.66 0.33 cm ; P < 0.05 ) oil groups .
-RESULTS	In the olive and canola oil groups , post-intervention grading of fatty liver was reduced significantly ( grade I , from 73.3 % to 23.3 % and from 60.5 % to 20 % , respectively [ P < 0.01 ] ; grade II , from 20 % to 10 % and from 33.4 % to 3.3 % , respectively [ P < 0.01 ] ; and grade III , from 6.7 % to none and from 6.1 % to none , respectively ) .
-RESULTS	In contrast , in the control oil group no significant change was observed .
-CONCLUSIONS	Results suggest significant improvements in grading of fatty liver , liver span , measures of insulin resistance , and lipids with use of canola and olive oil compared with control oils in Asian Indians with NAFLD .
-
-###24378475
-OBJECTIVE	An association of clinical and subclinical hypothyroidism with mild cognitive impairment ( MCI ) has not been established .
-OBJECTIVE	To evaluate the association of clinical and subclinical hypothyroidism with MCI in a large population-based cohort .
-METHODS	A cross-sectional , population-based study was conducted in Olmsted County , Minnesota .
-METHODS	Randomly selected participants were aged 70 to 89 years on October 1 , 2004 , and were without documented prevalent dementia [ CORRECTED ] .
-METHODS	A total of 2050 participants were evaluated and underwent in-person interview , neurologic evaluation , and neuropsychological testing to assess performance in memory , attention/executive function , and visuospatial and language domains .
-METHODS	Participants were categorized by consensus as being cognitively normal , having MCI , or having dementia according to published criteria .
-METHODS	Clinical and subclinical hypothyroidism were ascertained from a medical records linkage system .
-METHODS	Association of clinical and subclinical hypothyroidism with MCI .
-RESULTS	Among 1904 eligible participants , the frequency of MCI was 16 % in 1450 individuals with normal thyroid function , 17 % in 313 persons with clinical hypothyroidism , and 18 % in 141 individuals with subclinical hypothyroidism .
-RESULTS	After adjusting for covariates ( age , educational level , sex , apolipoprotein E 4 , depression , diabetes mellitus , hypertension , stroke , body mass index , and coronary artery disease ) we found no significant association between clinical or subclinical hypothyroidism and MCI ( odds ratio [ OR ] , 0.99 [ 95 % CI , 0.66-1 .48 ] and 0.88 [ 0.38-2 .03 ] , respectively ) .
-RESULTS	No effect of sex interaction was seen on these effects .
-RESULTS	In stratified analysis , the odds of MCI with clinical and subclinical hypothyroidism among men was 1.02 ( 95 % CI , 0.57-1 .82 ) and 1.29 ( 0.68-2 .44 ) and , among women , was 1.04 ( 0.66-1 .66 ) and 0.86 ( 0.37-2 .02 ) , respectively .
-CONCLUSIONS	In this population-based cohort of elderly people , neither clinical nor subclinical hypothyroidism was associated with MCI .
-CONCLUSIONS	Our findings need to be validated in a separate setting using the published criteria for MCI and confirmed in a longitudinal study .
-
-###24640441
-OBJECTIVE	To evaluate the clinical performance of adhesive restorations of resin composite and resin-modified glass-ionomer cements in primary molars .
-METHODS	This randomized clinical trial included subjects ( 5-9 year-old children ) selected at two university centers ( UFRGS and UNIFRA ) .
-METHODS	The sample consisted of 132 primary molars presenting active cavitated carious lesions ( with radiographic involvement of the inner half of the dentin ) , located on the occlusal and occlusal-proximal surface .
-METHODS	The sample was randomly divided into three groups , according to the restorative material : ( G1 ) universal restorative system ( Adper Single Bond 2 system and Filtek Z350 ) ; ( G2 ) : Resin-modified glass-ionomer cement ( Vitremer ) ; and ( G3 ) : Low shrink restorative system ( Filtek P90 ) .
-METHODS	The restorations were clinically and radiographically followed every 6 months for up to 18 months using the USPHS modified criteria for clinical evaluation .
-METHODS	Survival estimates for restoration longevity were evaluated using the Kaplan-Meier method .
-METHODS	Log-rank test ( P < 0.05 ) was used to compare the differences in the success rate according to the type of the restorative material .
-RESULTS	The type of restorative material used did not influence the longevity of the restorations .
-RESULTS	After clinical follow-up , there was no statistical difference in the rates of success for the three materials used to restore active cavitated carious lesions in primary molars .
-RESULTS	The survival rates for the follow-up were similar regarding the number of restored surfaces and the caries removal technique ( partial or complete ) .
-RESULTS	Mean estimated time of survival was 17.2 months ( 95 % CI : 16.7-17 .7 ) .
-RESULTS	Estimated survival rates of the restorations were 100 % , 98 % , 88 % and 65 % at 1 , 6 , 12 and 18 months of clinical evaluations , respectively .
-
-###25027180
-OBJECTIVE	This study aimed to evaluate whether a high relative ADP induced aggregation ( r-ADP-agg ) is associated with an increased mortality in patients after coronary stent implantation .
-BACKGROUND	Several trials were not able to improve clinical outcome by adapting platelet inhibition in patients after coronary stent implantation and high platelet reactivity ( HPR ) .
-BACKGROUND	Platelet monitoring is complex and conventional definition of adenosindiphosphate ( ADP ) induced aggregation alone might not transfer the whole picture of adequate platelet inhibition in vivo .
-METHODS	In a prospective single-centre observational trial multiple electrode aggregometry was performed in whole blood of patients after stent implantation .
-METHODS	r-ADP-agg was defined as the ADP-thrombin receptor activating peptide ratio to reflect an individual degree of P2Y12 dependent platelet inhibition with a cut-off value for HPR of 50 % .
-METHODS	The primary end point was mortality .
-RESULTS	Follow-up was completed in 176 of 184 patients ( 96 % ) with a mean follow-up time of 3.7 years .
-RESULTS	35 ( 20 % ) patients revealed an r-ADP-agg 50 % .
-RESULTS	An r-ADP-agg 50 % was associated with an increased mortality [ unadjusted hazard ratio ( HR ) 7.006 ( 2.561-19 .17 ) ; p = 0.0001 ] .
-RESULTS	In a multivariable Cox regression analysis mortality was independently associated with an r-ADP-agg 50 % [ HR 3.324 ( 1.542-7 .165 ) ; p = 0.0022 ] , ACS-setting [ HR 3.249 ( 1.322-7 .989 ) ; p = 0.0102 ] and severely reduced LV function [ HR 5.463 ( 2.098-14 .26 ) ; p = 0.0005 ] .
-CONCLUSIONS	An r-ADP-agg 50 % is associated with an increased mortality in patients after coronary stent implantation .
-CONCLUSIONS	Furthermore , r-ADP-agg might represent a better tool to predict clinical outcome than the conventional ADP induced platelet aggregation alone .
-
-###25946762
-BACKGROUND	The familial Mediterranean fever 50 score ( FMF50 ) score was recently devised to define response to treatment and as an outcome measure for clinical trials of FMF .
-OBJECTIVE	To examine the performance of the FMF50 score in a previously published trial of rilonacept for patients whose FMF was resistant or intolerant to colchicine .
-METHODS	We re-analyzed the data from our controlled trial of rilonacept vs. placebo in 14 patients with colchicine-resistant or intolerant FMF using the FMF50 score as the primary outcome .
-METHODS	The FMF50 score required improvement by 50 in five of six criteria ( attack frequency , attack duration , global patient assessment , global physician assessment , frequency of attacks with arthritis , and levels of acute-phase reactants ) without worsening of the sixth criterion .
-RESULTS	In the original trial rilonacept was considered effective according to the primary outcome measure ( differences in the attack frequency ) with eight analyzable patients considered responders and four as non-responders .
-RESULTS	According to the FMF50 score , only two participants would have been considered respondersto rilonacept , and one to placebo .
-RESULTS	Only two participants had 50 % differences between rilonacept and placebo in five criteria .
-RESULTS	The major explanation for non-response to treatment was that with rilonacept the duration of attack decreased by 50 % in only 2 participants and 5 participants had no attacks of arthritis either during screening ( before randomization ) or during treatment with rilonacept .
-CONCLUSIONS	The proposed FMF50 score did not differentiate well between responders and non-responders compared to the a priori defined primary outcome measure in this successful controlled study .
-
-###24590751
-OBJECTIVE	To test the effectiveness of messages designed to reduce vaccine misperceptions and increase vaccination rates for measles-mumps-rubella ( MMR ) .
-METHODS	A Web-based nationally representative 2-wave survey experiment was conducted with 1759 parents age 18 years and older residing in the United States who have children in their household age 17 years or younger ( conducted June-July 2011 ) .
-METHODS	Parents were randomly assigned to receive 1 of 4 interventions : ( 1 ) information explaining the lack of evidence that MMR causes autism from the Centers for Disease Control and Prevention ; ( 2 ) textual information about the dangers of the diseases prevented by MMR from the Vaccine Information Statement ; ( 3 ) images of children who have diseases prevented by the MMR vaccine ; ( 4 ) a dramatic narrative about an infant who almost died of measles from a Centers for Disease Control and Prevention fact sheet ; or to a control group .
-RESULTS	None of the interventions increased parental intent to vaccinate a future child .
-RESULTS	Refuting claims of an MMR/autism link successfully reduced misperceptions that vaccines cause autism but nonetheless decreased intent to vaccinate among parents who had the least favorable vaccine attitudes .
-RESULTS	In addition , images of sick children increased expressed belief in a vaccine/autism link and a dramatic narrative about an infant in danger increased self-reported belief in serious vaccine side effects .
-CONCLUSIONS	Current public health communications about vaccines may not be effective .
-CONCLUSIONS	For some parents , they may actually increase misperceptions or reduce vaccination intention .
-CONCLUSIONS	Attempts to increase concerns about communicable diseases or correct false claims about vaccines may be especially likely to be counterproductive .
-CONCLUSIONS	More study of pro-vaccine messaging is needed .
-
-###24868024
-OBJECTIVE	In Asian countries , paclitaxel once per week is used as second-line treatment in advanced gastric cancer , including human epidermal growth factor receptor 2 ( HER2 ) - positive tumors .
-OBJECTIVE	The role of anti-HER2 agents , including lapatinib , in this setting and population is unclear .
-METHODS	TyTAN was a two-part , parallel-group , phase III study in Asian patients .
-METHODS	An open-label , dose-optimization phase ( n = 12 ) was followed by a randomized phase ( n = 261 ) , in which patients who were HER2 positive by fluorescence in situ hybridization ( FISH ) received lapatinib 1,500 mg once per day plus once-per-week paclitaxel 80 mg/m ( 2 ) or paclitaxel alone .
-METHODS	The primary end point was overall survival ( OS ) .
-METHODS	Secondary end points included progression-free survival ( PFS ) , time to progression ( TTP ) , overall response rate ( ORR ) , time to response , response duration , and safety .
-METHODS	Analyses were based on immunohistochemistry ( IHC ) and gastrectomy status , prior trastuzumab therapy , and regional subpopulations .
-RESULTS	Median OS was 11.0 months with lapatinib plus paclitaxel versus 8.9 months with paclitaxel alone ( P = .1044 ) , with no significant difference in median PFS ( 5.4 v 4.4 months ) or TTP ( 5.5 v 4.4 months ) .
-RESULTS	ORR was higher with lapatinib plus paclitaxel versus paclitaxel alone ( odds ratio , 3.85 ; P < .001 ) .
-RESULTS	Better efficacy with lapatinib plus paclitaxel was demonstrated in IHC3 + compared with IHC0/1 + and 2 + patients and in Chinese compared with Japanese patients .
-RESULTS	A similar proportion of patients experienced adverse events with each treatment ( lapatinib plus paclitaxel , 100 % v paclitaxel alone , 98 % ) .
-CONCLUSIONS	Lapatinib plus paclitaxel demonstrated activity in the second-line treatment of patients with HER2 FISH-positive IHC3 + advanced gastric cancer but did not significantly improve OS in the intent-to-treat population .
-
-###24470701
-OBJECTIVE	To evaluate the efficacy of a brief 4-w group-administered treatment program of cognitive behavior therapy for insomnia ( CBT-I ) for older adults with sleep maintenance insomnia .
-METHODS	Randomized controlled trial of CBT-I compared to waitlist control with comparisons at pretreatment , posttreatment , and 3-mo follow-up .
-METHODS	Flinders University Sleep and Circadian Rhythm Research Laboratory , Adelaide , South Australia .
-METHODS	One-hundred eighteen adults with sleep maintenance insomnia ( mean age = 63.76 y , standard deviation = 6.45 y , male = 55 ) .
-METHODS	A 4-w , group-based treatment program of CBT-I including bedtime restriction therapy , sleep education , and cognitive restructuring .
-METHODS	Seven-day sleep diaries , actigraphy , and several self-report measures to assess perceived insomnia severity , daytime functioning , and confidence in and beliefs about sleep .
-RESULTS	The brief group-administered CBT-I program produced improvements in the timing and quality of sleep including later bedtimes , earlier out-of-bed times , reduced wake after sleep onset , and improved sleep efficiency .
-RESULTS	Participants also reported a reduction of the Insomnia Severity Index , Flinders Fatigue Scale , Epworth Sleepiness Scale , Daytime Feeling and Functioning Scale , Sleep Anticipatory Anxiety Questionnaire , the Dysfunctional Beliefs and Attitudes Scale , and increased Sleep Self-Efficacy Scale .
-CONCLUSIONS	The treatment program used in the current study has demonstrated potential for a brief , inexpensive , and effective treatment of sleep maintenance insomnia in the older adult population .
-
-###24351875
-BACKGROUND	Eating carbohydrate foods with a high glycemic index ( GI ) has been postulated to result in fetoplacental overgrowth and higher infant body fat .
-BACKGROUND	A diet with a low glycemic index ( LGI ) has been shown to reduce birth percentiles and the ponderal index ( PI ) .
-OBJECTIVE	We investigated whether offering LGI dietary advice at the first antenatal visit would result in a lower fetal birth weight , birth percentile , and PI than providing healthy eating ( HE ) advice .
-OBJECTIVE	This advice had to be presented within the resources of routine antenatal care .
-METHODS	The Pregnancy and Glycemic Index Outcomes study was a 2-arm , parallel-design , randomized , controlled trial that compared the effects of LGI dietary advice with HE advice on pregnancy outcomes .
-METHODS	Eligible volunteers who attended for routine antenatal care at < 20 wk of gestation were randomly assigned to either group .
-RESULTS	A total of 691 women were enrolled , and 576 women had final data considered .
-RESULTS	In the LGI group , the GI was reduced from a mean ( SEM ) of 56 0.3 at enrollment to 52 0.3 ( P < 0.001 ) at the final assessment .
-RESULTS	There were no significant differences in primary outcomes of fetal birth weight , birth percentile , or PI .
-RESULTS	In a multivariate regression analysis , the glycemic load was the only significant dietary predictor ( P = 0.046 ) of primary outcomes but explained < 1 % of all variation .
-CONCLUSIONS	A low-intensity dietary intervention with an LGI diet compared with an HE diet in pregnancy did not result in any significant differences in birth weight , fetal percentile , or PI .
-
-###25359163
-BACKGROUND	A large body of epidemiological and experimental evidence suggests that vitamin D deficiency may promote hypertension .
-BACKGROUND	This raises the possibility that vitamin D supplementation could be a simple intervention to reduce blood pressure , but data from prospective , randomized trials are limited .
-RESULTS	A double-blind , randomized , controlled trial was conducted at 4 sites in the United States .
-RESULTS	We enrolled 534 individuals 18 to 50 years of age with low vitamin D status ( 25-hydroxyvitamin D levels 25 ng/mL ) and systolic blood pressure of 120 to 159 mm Hg .
-RESULTS	Participants were randomized to high-dose ( 4000 IU/d ) versus low-dose ( 400 IU/d ) oral vitamin D3 for 6 months .
-RESULTS	The primary end point was change in mean 24-hour systolic blood pressure .
-RESULTS	Secondary end points included change in ambulatory diastolic blood pressure and clinic systolic and diastolic blood pressures .
-RESULTS	The median age was 38 years , and 62 % of participants were men .
-RESULTS	Forty-six percent of participants were white , and 48 % were black .
-RESULTS	The median 25-hydroxyvitamin D level at baseline was 15.3 ng/mL .
-RESULTS	Four-hundred fifty-five participants ( 85 % ) had at least 1 follow-up blood pressure measurement ; 383 participants ( 72 % ) completed the full 6-month study .
-RESULTS	At the end of the study , there was no significant difference in the primary end point ( change in mean 24-hour systolic blood pressure , -0.8 versus -1.6 mm Hg in the high-dose and low-dose arms ; P = 0.71 ) or in any of the secondary end points .
-RESULTS	Furthermore , there was no evidence of association between change in 25-hydroxyvitamin D and change in 24-hour systolic blood pressure at 6 months ( Spearman correlation coefficient , -0.05 , P = 0.34 ) .
-RESULTS	Results were consistent across prespecified subgroups .
-CONCLUSIONS	Vitamin D supplementation did not reduce blood pressure in individuals with prehypertension or stage I hypertension and vitamin D deficiency .
-CONCLUSIONS	Our findings suggest that the association between vitamin D status and elevated blood pressure noted in observational studies is not causal .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT01240512 .
-
-###24831438
-BACKGROUND	Threshold levels for peanut allergy determined by using oral challenges are important for the food industry with regard to allergen labeling .
-BACKGROUND	Moreover , the utility of biological markers in predicting threshold levels is uncertain .
-OBJECTIVE	We sought to use a modified oral food challenge regimen that might determine threshold levels for peanut allergy mimicking a more real-life exposure and to correlate the eliciting dose ( ED ) and severity of clinical reaction in children with peanut allergy with B-cell , T-cell , and effector cell markers .
-METHODS	A modified food challenge procedure with doses scheduled 2 hours apart was used in 63 children with peanut allergy .
-METHODS	All children received a maximum of 8 semi-log increasing titration steps of roasted peanuts ranging from 3 to 4500 mg of peanut protein until objective allergic reactions occurred .
-METHODS	Severity of symptoms was graded from I to V. Biological markers were measured before challenge .
-RESULTS	Forty-five of 63 patients showed objective symptoms after greater than 30 minutes , with a median latency of clinical reaction of 55 minutes .
-RESULTS	By using a log-normal dose-distribution model , the ED5 was calculated to be 1.95 mg of peanut protein .
-RESULTS	The ED was significantly and inversely correlated with peanut - and Ara h 2-specific IgE levels , skin prick test responses , basophil activation , and TH2 cytokine production by PBMCs .
-RESULTS	Symptom severity did not correlate with any of the markers or the ED .
-CONCLUSIONS	This modified food challenge procedure might better reflect threshold levels for peanut allergy than the standard procedure because most of the patients reacted at a time interval of greater than 30 minutes .
-CONCLUSIONS	By using this model , threshold levels , but not severity , could be correlated with biological markers .
-
-###25957003
-OBJECTIVE	Bleeding esophageal varices has been studied extensively , but bleeding gastric varices ( BGV ) has received much less investigation .
-OBJECTIVE	However , BGV has been reported in 30 % of patients with acute variceal bleeding .
-OBJECTIVE	In our studies of 1,836 bleeding cirrhotics , 12.7 % were bleeding from gastric varices .
-OBJECTIVE	BGV mortality rate of 45-55 % has been reported .
-OBJECTIVE	The BGV literature has mainly involved retrospective case reports , often with short-term follow-up .
-OBJECTIVE	We sought to describe the results of a prospective , randomized , controlled trial ( RCT ) in unselected , consecutive patients with BGV comparing endoscopic therapy ( ET ) with portacaval shunt ( PCS ; n = 518 ) , and later comparing emergency transjugular intrahepatic portosystemic shunt ( TIPS ) with emergency portacaval shunt ( EPCS ; n = 70 ) .
-METHODS	Initially , our RCT involved 518 patients with BGV comparing ET with direct PCS regarding control of bleeding , mortality rate , and disability .
-METHODS	When entry of patients ended , the RCT was expanded to compare emergency TIPS with EPCS ( n = 70 ) .
-METHODS	This RCT of BGV was separate from our other RCTs of bleeding esophageal varices .
-METHODS	Initially , ET was compared with PCS .
-METHODS	In the second part of our RCT , emergency TIPS was compared with emergency PCS ( EPCS ) .
-METHODS	Outcomes were survival , control of bleeding , portal-systemic encephalopathy ( PSE ) , quality of life , and direct costs of care .
-METHODS	In the RCT of ET versus PCS , 28 and 30 % , respectively , were in Child class C.
-METHODS	In the expanded RCT of TIPS versus EPCS , 40 and 41 % , respectively , were in Child class C. Permanent control of BGV was achieved in 97-100 % of patients treated by emergency or elective PCS , compared with 27-29 % by ET .
-METHODS	TIPS was even less effective , achieving long-term control of BGV in only 6 % .
-METHODS	Survival rates after PCS were greater at all time intervals and in all Child classes ( P < .001 ) .
-METHODS	Repeated episodes of PSE occurred in 50 % of TIPS patients , 16-17 % treated by ET , and 8-11 % treated by PCS .
-METHODS	Shunt stenosis or occlusion occurred in 67 % of TIPS patients , in contrast with 0-2 % of PCS patients .
-CONCLUSIONS	These results support the conclusion that PCS is uniformly effective , whereas ET and TIPS are not very effective .
-
-###24700992
-OBJECTIVE	To measure the extent , determinants and results of bypassing local primary care clinics for childbirth among women in rural parts of the United Republic of Tanzania .
-METHODS	Women were selected in 2012 to complete a structured interview from a full census of all 30076 households in clinic catchment areas in Pwani region .
-METHODS	Eligibility was limited to those who had delivered between 6 weeks and 1 year before the interview , were at least 15 years old and lived within the catchment areas .
-METHODS	Demographic and delivery care information and opinions on the quality of obstetric care were collected through interviews .
-METHODS	Clinic characteristics were collected from staff via questionnaires .
-METHODS	Determinants of bypassing ( i.e. delivery of the youngest child at a health centre or hospital without provider referral ) were analysed using multivariate logistic regression .
-METHODS	Bypasser and non-bypasser birth experiences were compared in bivariate analyses .
-RESULTS	Of 3019 eligible women interviewed ( 93 % response rate ) , 71.0 % ( 2144 ) delivered in a health facility ; 41.8 % ( 794 ) were bypassers .
-RESULTS	Bypassing likelihood increased with primiparity ( odds ratio , OR : 2.5 ; 95 % confidence interval , CI : 1.9-3 .3 ) and perceived poor quality at clinics ( OR : 1.3 ; 95 % CI : 1.0-1 .7 ) and decreased if clinics recently underwent renovations ( OR : 0.39 ; 95 % CI : 0.18-0 .84 ) and/or performed 4 obstetric signal functions ( OR : 0.19 ; 95 % CI : 0.08-0 .41 ) .
-RESULTS	Bypassers reported better quality of care on six of seven quality of care measures .
-CONCLUSIONS	Many pregnant women , especially first-time mothers , choose to bypass local primary care clinics for childbirth .
-CONCLUSIONS	Perceived poor quality of care at clinics was an important reason for bypassing .
-CONCLUSIONS	Primary care is failing to meet the obstetric needs of many women in this rural , low-income setting .
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-###25127483
-BACKGROUND	Long-term effects of behavioural weight loss interventions on diabetes complications are unknown .
-BACKGROUND	In a secondary analysis of the Look AHEAD ( Action for Health in Diabetes ) multicentre randomised clinical trial , we assessed whether an intensive lifestyle intervention ( ILI ) affects the development of nephropathy in people with type 2 diabetes .
-METHODS	Overweight or obese people aged 45-76 years with type 2 diabetes were randomly assigned ( 1:1 ) to ILI or to a diabetes support and education ( DSE ) group by a central web-based data management system , stratified by clinical centre and blocked with random block sizes .
-METHODS	The ILI was designed to achieve and maintain weight loss through reduced caloric consumption and increased physical activity .
-METHODS	The interventions were terminated early because of absence of effect on the primary outcome of cardiovascular disease events in the main Look AHEAD trial .
-METHODS	Albuminuria and estimated glomerular filtration rate were prespecified as two of many other outcomes and were assessed from baseline until the interventions ended .
-METHODS	They were combined post hoc to define the main outcome for this report , very-high-risk chronic kidney disease ( CKD ) , based on the 2013 Kidney Disease Improving Global Outcomes ( KDIGO ) classification .
-METHODS	Outcomes assessors and laboratory staff were masked to treatment , but participants and interventionists were not masked .
-METHODS	Time-to-event data were analysed by intention to treat by the Kaplan-Meier method and proportional hazards models .
-METHODS	The Look AHEAD trial is registered with ClinicalTrials.gov , NCT00017953 .
-RESULTS	Of the 5145 participants randomly assigned in the Look AHEAD trial ( 2570 to ILI and 2575 to DSE ) , analyses for very-high-risk CKD were done in 2423 ( 94 % ) of patients in the ILI group and 2408 ( 94 % ) of those in the DSE group .
-RESULTS	After a median of 80 years ( IQR 79-99 ) of follow-up , the incidence of very-high-risk CKD was lower in the ILI group than in the DSE group , with incidence rates of 091 cases per 100 person-years in the DSE group and 063 per 100 person-years in the ILI group ( difference 027 cases per 100 person-years , hazard ratio 069 , 95 % CI 055-087 ; p = 00016 ) .
-RESULTS	This effect was partly attributable to reductions in bodyweight , HbA1c , and systolic blood pressure .
-RESULTS	There were no safety concerns regarding kidney-related adverse events .
-CONCLUSIONS	Weight loss should be considered as an adjunct to medical treatments to prevent or delay progression of CKD in overweight or obese people with type 2 diabetes .
-BACKGROUND	National Institute of Diabetes and Digestive and Kidney Diseases .
-
-###24420746
-OBJECTIVE	To identify factors associated with variability in rifampin plasma pharmacokinetics and explore the relationship between rifampin pharmacokinetics and change in efavirenz plasma pharmacokinetics with rifampin coadministration .
-METHODS	In this randomized , cross-over study , 12 healthy volunteers received either efavirenz 600mg/day or efavirenz 600mg with rifampin 600mg/day for 8days .
-METHODS	After a washout period of at least 2weeks , subjects crossed over to the alternate 8-day regimen .
-METHODS	Samples were obtained for pharmacokinetic assessment on day 8 of each study cycle .
-METHODS	Drugs concentrations were determined by a validated high-performance liquid chromatography .
-METHODS	Pharmacokinetic parameters were calculated using noncompartmental analysis .
-METHODS	Multivariate analysis was used to examine factors associated with rifampin pharmacokinetics .
-METHODS	Spearman correlation analysis was used to investigate relationship between rifampin pharmacokinetics and change in efavirenz plasma pharmacokinetics with rifampin coadministration .
-RESULTS	Of 11 evaluable subjects , the median interquartile range , rifampin peak concentration ( Cmax ) , area under the concentration-time curve ( AUC0-24hour ) , and weight-normalized clearance were 8.9 ( 7.3-13 .8 ) g/ml , 48.8 ( 29.6-67 .4 ) gh/ml , and 0.19 ( 0.11-0 .29 ) L/h/kg , respectively .
-RESULTS	Solute carrier organic anion transporter family member 1B1 ( SLCO1B1 ) c. 388AG and SLCO1B1 c. 463CA polymorphisms jointly had significant effect on rifampin Cmax ( R ( 2 ) = 0.75 ) .
-RESULTS	Male sex and SLCO1B1 c. 463CA polymorphism together influenced rifampin AUC0-24hour ( R ( 2 ) = 0.52 ) and weight-normalized clearance ( R ( 2 ) = 0.65 ) .
-RESULTS	All four volunteers with rifampin Cmax less than8g/ml ( lower end of the normal range ) had c. 463CA genotype .
-RESULTS	Rifampin Cmax and AUC0-24hour had no significant relationship with the efavirenz AUC0-24hour ratio or weight-normalized clearance ratio in the presence versus absence of rifampin ( p > 0.05 ) .
-CONCLUSIONS	Men with the SLCO1B1c .463 CA genotype are at increased risk of lower rifampin plasma exposure .
-CONCLUSIONS	However , plasma rifampin concentrations did not correlate with the extent of induction of efavirenz clearance by rifampin during coadministration .
-
-###25456093
-OBJECTIVE	The aim of this study is to assess the prevalence of non-opioid drug use among opioid-addicted , buprenorphine injecting individuals in Georgia , during and after a 12-week course of buprenorphine-naloxone ( Suboxone ) or methadone .
-METHODS	Randomized controlled trial with daily observed Suboxone or methadone and weekly counseling , urine tests and timeline followback ( TLFB ) in weeks 0-12 and 20 , and the Addiction Severity Index ( ASI ) at weeks 0 , 4 , 8 , 12 , 20 .
-RESULTS	Of the 80 patients ( 40/group , 4 women ) , 68 ( 85 % ) completed the 12-weeks of study treatment and 66 ( 82.5 % ) completed the 20-week follow-up .
-RESULTS	At baseline , injecting more than one drug in the last 30 days was reported by 68.4 % of patients in the methadone and 72.5 % in the Suboxone groups .
-RESULTS	Drug use was markedly reduced in both treatment conditions but there were significant differences in the prevalence of specific drugs with more opioid ( 1.5 vs. 0.2 % ; p = 0.03 ) , less amphetamine ( 0.2 vs. 2.8 % ; p < 0.001 ) and less marijuana ( 1.7 vs. 10.2 % ; p < 0.001 ) positive urine tests in the methadone vs. Suboxone groups .
-RESULTS	At the 20-week follow-up , TLFB results on the 34 that continued methadone or the 3 on Suboxone showed less opioid ( 5.6 vs. 27.6 % ; p < 0.001 ) , illicit buprenorphine ( 2.7 vs. 13.8 % ; p = 0.005 ) , benzodiazepine ( 13.5 vs. 34.5 % ; p < 0.001 ) , and marijuana ( 2.8 vs. 20.7 % ; p < 0.001 ) use than the 29 who did not continue opioid substitution therapy .
-CONCLUSIONS	Despite small but significant differences in opioid and other drug use , both treatments were highly effective in reducing opioid and non-opioid drug use .
-
-###24773119
-OBJECTIVE	To determine the effectiveness of an interactive educational intervention on a physiotherapy guideline for hip and knee osteoarthritis .
-METHODS	Physiotherapists were randomly allocated to a 3-h interactive educational course with the collaboration of three patient partners or no intervention .
-METHODS	Assessments comprised questionnaires on adherence ( score range 0-24 ) , knowledge ( score range 0-76 ) , and barriers to use the guideline ( score range 0-80 ) .
-METHODS	Assessments were conducted 1 week before the interactive course ( T0 ) immediately after ( T1 ) , and 3 months thereafter ( T2 ) .
-METHODS	Change scores were compared between the groups by means of Mann-Whitney U tests and linear mixed models .
-RESULTS	284 of 4328 eligible PTs ( 7 % ) were included .
-RESULTS	The intervention ( n = 133 ) was significantly more effective than no intervention ( n = 151 ) concerning self-reported adherence and knowledge with mean differences in change scores ( 95 % CI ) at T1 and T2 being 1.4 ( 0.7-2 .0 ) and 0.9 ( 0.2-1 .7 ) for adherence and 6.8 ( 4.5-9 .1 ) and 3.9 ( 1.7-6 .2 ) for knowledge , ( all p values < 0.005 ) .
-RESULTS	In both groups the barrier score increased at T1 and decreased at T2 , with a significantly larger increase at T1 and decrease at T2 in the intervention group ( mean differences 3.1 ( 1.8-4 .4 ) and 3.3 ( 0.5-6 .1 ) , respectively .
-CONCLUSIONS	A short interactive educational course with patient participation on a PT guideline on hip and knee osteoarthritis showed a small to moderate positive effect on self-reported guideline adherence and knowledge , whereas for perceived barriers an advantage was only seen on the longer term .
-
-###25925415
-BACKGROUND	Moderate , regular alcohol consumption is generally associated with a lower risk of cardiovascular events but data in patients with chronic heart failure are scarce .
-BACKGROUND	We evaluated the relations between wine consumption , health status , circulating biomarkers , and clinical outcomes in a large Italian population of patients with chronic heart failure enrolled in a multicenter clinical trial .
-RESULTS	A brief questionnaire on dietary habits was administered at baseline to 6973 patients enrolled in the Gruppo Italiano per lo Studio della Sopravvivenza nell ` Insufficienza Cardiaca-Heart Failure ( GISSI-HF ) trial .
-RESULTS	The relations between wine consumption , fatal and nonfatal clinical end points , quality of life , symptoms of depression , and circulating biomarkers of cardiac function and inflammation ( in subsets of patients ) were evaluated with simple and multivariable-adjusted statistical models .
-RESULTS	Almost 56 % of the patients reported drinking at least 1 glass of wine per day .
-RESULTS	After adjustment , clinical outcomes were not significantly different in the predefined 4 groups of wine consumption .
-RESULTS	However , patients with more frequent wine consumption had a significantly better perception of health status ( Kansas City Cardiomyopathy Questionnaire score , adjusted P < 0.0001 ) , less frequent symptoms of depression ( Geriatric Depression Scale , adjusted P = 0.01 ) , and lower plasma levels of biomarkers of vascular inflammation ( osteoprotegerin and C-terminal proendothelin-1 , adjusted P < 0.0001 , and pentraxin-3 , P = 0.01 ) after adjusting for possible confounders .
-CONCLUSIONS	We show for the first time in a large cohort of patients with chronic heart failure that moderate wine consumption is associated with a better perceived and objective health status , lower prevalence of depression , and less vascular inflammation , but does not translate into more favorable clinical 4-year outcomes .
-BACKGROUND	URL : http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT0033633 .
-
-###25161024
-BACKGROUND	Recent randomised controlled trials have compared the effects of albumin and hydroxyethyl starch ( HES ) v crystalloids on patient-centred outcomes in critically ill patients .
-BACKGROUND	The Saline v Albumin Fluid Evaluation ( SAFE ) trial reported patient-centred outcomes at 28 days in 6933 patients assigned to fluid resuscitation with either 4 % albumin or 0.9 % saline ; the Crystalloid v Hydroxyethyl Starch Trial ( CHEST ) reported patient-centred outcomes at 28 days in 6644 patients assigned to fluid resuscitation with either 6 % HES ( 130/0 .4 ) or 0.9 % saline .
-BACKGROUND	As the two trials used a common reference fluid ( 0.9 % saline ) and had most trial methods and data collection points harmonised , a comparison of 4 % albumin and 6 % HES ( 130/0 .4 ) on patient-centred outcomes at 28 days in critically ill patients using the individual patient data from the two trials is feasible .
-OBJECTIVE	To prepublish the statistical analysis plan ( SAP ) of an individual patient data comparative analysis of the SAFE and CHEST studies .
-METHODS	The statistical analyses are described in detail with the appropriate statistical analysis specified .
-RESULTS	The planned statistical analyses are described in detail for the SAFE and CHEST individual patient data comparative analysis .
-RESULTS	We outline the proposed statistical analysis for the baseline characteristics , processes of care and the outcomes .
-RESULTS	Subgroups are defined with statistical comparisons between the fluid groups and in each subgroup explained .
-CONCLUSIONS	We have developed a SAP for the SAFE / CHEST individual patient data comparative analysis to increase the internal validity of the study and minimise bias .
-
-###25449059
-BACKGROUND	Studies have shown that tiotropium once daily reduces lung hyperinflation and dyspnea during exercise and improves exercise tolerance in patients with COPD .
-BACKGROUND	Mechanisms underlying the effects of the muscarinic receptor antagonist tiotropium on COPD have not been fully understood .
-OBJECTIVE	In this study , we investigated whether improvement in neural respiratory drive is responsible for reducing dyspnea during exercise and improving exercise tolerance in COPD .
-METHODS	Twenty subjects with severe COPD were randomized into two groups : no treatment ( Control , n = 10 , 63.64.6 years , FEV1 29.613.3 % pred ) or inhaled tiotropium 18g once daily for 1 month ( n = 10 , 66.55.4 years , FEV1 33.011.1 % pred ) .
-METHODS	All subjects were allowed to continue their daily medications other than anti-cholinergics during the study .
-METHODS	Constant cycle exercise with 75 % of maximal workload and spirometry were performed before and 1 month after treatment .
-METHODS	Diaphragmatic EMG ( EMGdi ) and respiratory pressures were recorded with multifunctional esophageal catheter .
-METHODS	Efficiency of neural respiratory drive , defined as the ratio of minute ventilation ( VE ) and diaphragmatic EMG ( VE/EMGdi % max ) , was calculated .
-METHODS	Modified British Medical Research Council Dyspnea Scale ( mMRC ) was used for the evaluation of dyspnea before and after treatment .
-RESULTS	There was no significant difference in spirometry before and after treatment in both groups .
-RESULTS	Diaphragmatic EMG decreased significantly at rest ( 28.110.9 % vs. 22.610.7 % , P < 0.05 ) and mean efficiency of neural respiratory drive at the later stage of exercise increased ( 39.82.9 vs. 45.23.9 , P < 0.01 ) after 1-month treatment with tiotropium .
-RESULTS	There were no remarkable changes in resting EMGdi and mean efficiency of neural respiratory drive post-treatment in control group .
-RESULTS	The score of mMRC decreased significantly ( 2.50.5 vs. 1.90.7 , P < 0.05 ) after 1-month treatment with tiotropium , but without significantly difference in control group .
-CONCLUSIONS	Tiotropium significantly reduces neural respiratory drive at rest and improves the efficiency of neural respiratory drive during exercise , which might account for the improvement in exercise tolerance in COPD .
-
-###24378207
-BACKGROUND	Combined treatment with a bisphosphonate and vitamin D has been proposed for postmenopausal osteoporosis .
-BACKGROUND	A new , fixed-dose combination tablet of ibandronate plus vitamin D3 has been developed for monthly administration to treat postmenopausal osteoporosis .
-OBJECTIVE	The main objective of the present study was to compare the pharmacokinetics of vitamin D3 administered in 2 forms : a newly developed ibandronate 150-mg/vitamin D3 24,000-IU tablet ( DP-R206 , test drug ) and a stand-alone vitamin D3 24,000-IU tablet ( reference drug ) .
-OBJECTIVE	A secondary objective was to evaluate the safety and tolerability of DP-R206 in healthy adult male Korean volunteers .
-METHODS	This study was a single-dose , open-label , randomized-sequence , 2-treatment , 2-way crossover trial .
-METHODS	Blood samples were collected from 24 hours ' predose to 120 hours ' postdose .
-METHODS	The plasma concentrations of vitamin D3 were analyzed by using a validated HPLC-MS/MS method .
-METHODS	Pharmacokinetic parameters were calculated , and the 90 % CIs of the ratios of the geometric means of the parameters were determined from the logarithmically transformed data by using ANOVA .
-RESULTS	Thirty-sex healthy adult male Korean volunteers with a mean ( SD ) age of 25.8 ( 2.7 ) years , a mean height of 174.0 ( 5.9 ) cm , and a mean weight of 69.1 ( 6.2 ) kg were enrolled ; 29 participants completed the study .
-RESULTS	The 90 % CIs of the ratios of the geometric means ( test drug/reference drug ) of the baseline-corrected Cmax , AUC0-last , and AUC0 - values were 0.93 to 1.24 , 0.89 to 1.19 , and 0.87 to 1.18 , respectively .
-RESULTS	The 90 % CIs of the ratios of the geometric means ( test drug/reference drug ) of the baseline-uncorrected Cmax , AUC0-last , and AUC0 - values were 0.93 to 1.24 , 0.88 to 1.19 , and 0.87 to 1.18 , respectively .
-RESULTS	Eighty-four adverse events ( AEs ) were reported in 24 of 32 subjects receiving DP-R206 , and 14 AEs were reported in 8 of 29 subjects receiving the vitamin D3 24,000-IU tablet .
-RESULTS	All of the subjects who experienced AEs recovered without sequelae , and no serious AEs were observed .
-CONCLUSIONS	The vitamin D3 pharmacokinetics were similar for DP-R206 and the 24,000-IU vitamin D3 tablet .
-CONCLUSIONS	DP-R206 was well tolerated .
-
-###24952740
-BACKGROUND	Care management interventions in the German health-care system have been evaluated with promising results , but further research is necessary to explore their full potential in the context of multi-morbidity .
-BACKGROUND	Our aim in this trial is to assess the efficacy of a primary care practice network-based care management intervention in improving self-care behaviour among patients with type 2 diabetes mellitus and multiple co-occurring chronic conditions .
-METHODS	The study is designed as a prospective , 18-month , multicentre , investigator-blinded , two-arm , open-label , individual-level , randomized parallel-group superiority trial .
-METHODS	We will enrol 582 patients with type 2 diabetes mellitus and at least two severe chronic conditions and one informal caregiver per patient .
-METHODS	Data will be collected at baseline ( T0 ) , at the primary endpoint after 9months ( T1 ) and at follow-up after 18months ( T2 ) .
-METHODS	The primary outcome will be the differences between the intervention and control groups in changes of diabetes-related self-care behaviours from baseline to T1 using a German version of the revised Summary of Diabetes Self-Care Activities ( SDSCA-G ) .
-METHODS	The secondary outcomes will be the differences between the intervention and control groups in : changes in scores on the SDSCA-G subscales , glycosylated haemoglobin A level , health-related quality of life , self-efficacy , differences in ( severe ) symptomatic hypoglycaemia , cost-effectiveness and financial family burden .
-METHODS	The intervention will be delivered by trained health-care assistants as an add-on to usual care and will consist of three main elements : ( 1 ) three home visits , including structured assessment of medical and social needs ; ( 2 ) 24 structured telephone monitoring contacts ; and ( 3 ) self-monitoring of blood glucose levels after T1 in 3-month intervals .
-METHODS	The control group will receive usual care .
-METHODS	The confirmatory primary analysis will be performed following the intention-to-treat ( ITT ) principle .
-METHODS	The efficacy of the intervention will be quantified using two-level linear regression stratified by type of medical treatment adjusted for baseline values on the SDSCA-G .
-METHODS	Secondary analyses will be performed according to the ITT principle .
-METHODS	In health economic evaluations , we will estimate the incremental cost-effectiveness ratios .
-CONCLUSIONS	We hope that the results of this study will provide insights into the efficacy of practice network-based care management among patients with complex health-care needs .
-BACKGROUND	Current Controlled Trials ISRCTN 83908315 ( ISRCTN assigned 25 February 2014 ) .
-
-###24299521
-OBJECTIVE	To determine if cats anaesthetised with alfaxalone have different recoveries to cats anaesthetised with a combination of ketamine and diazepam .
-METHODS	Anaesthesia for ovariohysterectomy was induced in cats with either alfaxalone ( n = 23 ) or a combination of ketamine and diazepam ( n = 22 ) .
-METHODS	All cats were premedicated with combinations of acepromazine and morphine .
-METHODS	Recoveries were scored using a categorical grading scheme applied to 18 parameters over 60 minutes following extubation .
-METHODS	The parameters scored covered movement , sensitivity to touch , sound and light , body position , sneezing and vocalisation .
-METHODS	One person scored all recoveries and they were blinded to the induction drug used .
-METHODS	Scores were compared between drugs at different times using the Kruskal-Wallis rank sum test .
-RESULTS	Recovery scores were not normally distributed .
-RESULTS	Analysis of the data using the Kruskal-Wallis rank sum test revealed that cats induced with alfaxalone showed an increase in recovery scores at 5 minutes for pawing at the head ( p = 0.001 ) .
-RESULTS	No parameters differed significantly at 10 and 20 minutes .
-RESULTS	For cats anaesthetised with ketamine and diazepam there was an increase at 30 minutes in pacing , jerky sudden movements , unsettledness and increased sensitivity to touch at the surgical site and on the head ( p0 .01 ) .
-RESULTS	At 60 minutes cats anaesthetised with ketamine and diazepam still showed an increase in unsettledness compared to those cats anaesthetised with alfaxalone ( p = 0.005 ) .
-CONCLUSIONS	The results suggest that recoveries of cats following alfaxalone induction are significantly different to recoveries after induction with ketamine and diazepam .
-CONCLUSIONS	Overall , cats induced with ketamine and diazepam had more active and unsettled recoveries than alfaxalone over the 60-minute period observed .
-CONCLUSIONS	Cats recovering from alfaxalone anaesthesia have more settled recoveries than cats recovering from ketamine and diazepam anaesthesia .
-CONCLUSIONS	If a quiet settled recovery is desired following a surgical procedure , alfaxalone is likely to be a better choice than ketamine and diazepam .
-
-###24997349
-BACKGROUND	Psychosocial stress is accompanied by an increase in the activity of the hypothalamic-pituitary-adrenocortical ( HPA ) - axis and by an increase in food intake .
-BACKGROUND	At present , no studies have been conducted to examine the impact of a potent laboratory stress test on the chewing frequency .
-METHODS	Thirty-one healthy participants ( 14 females , mean age 27.13 ) were compared after they had fulfilled the protocol of a standardized psychosocial stress test , the Trier Social Stress Test ( TSST ) , and after a resting condition of silent reading in reference to their chewing frequency , chewing efficacy , food intake , and eating preferences .
-METHODS	As part of the design free salivary cortisol levels and heart rate variability were measured repeatedly before and after the TSST and the resting condition .
-RESULTS	After the TSST , the participants exhibited a significantly higher mean chewing frequency than after the resting condition ( F ( 2,60 ) = 3.600 , p = .035 , ( 2 ) = .107 ) .
-RESULTS	The testing condition had no influence on the amount of food intake .
-RESULTS	Following the psychosocial stress , however , the participants reported a significantly less general appetite ( Z = -3.921 , p < .001 ) and less of an appetite for eggs ( Z = -2.023 , p = .043 ) than after their resting condition .
-RESULTS	No correlation was found between the salivary cortisol response and the chewing frequency .
-CONCLUSIONS	The results indicated that psychosocial stress is associated with an increase in chewing frequency , as measured with a sound-based apparatus , and with a decrease in appetite .
-
-###25872617
-BACKGROUND	Health knowledge and literacy are among the main determinants of health .
-BACKGROUND	Assessment of these issues via Web-based surveys is growing continuously .
-BACKGROUND	Research has suggested that approximately one-fifth of respondents submit cribbed answers , or cheat , on factual knowledge items , which may lead to measurement error .
-BACKGROUND	However , little is known about methods of discouraging cheating in Web-based surveys on health knowledge .
-OBJECTIVE	This study aimed at exploring the usefulness of imposing a survey time limit to prevent help-seeking and cheating .
-METHODS	On the basis of sample size estimation , 94 undergraduate students were randomly assigned in a 1:1 ratio to complete a Web-based survey on nutrition knowledge , with or without a time limit of 15 minutes ( 30 seconds per item ) ; the topic of nutrition was chosen because of its particular relevance to public health .
-METHODS	The questionnaire consisted of two parts .
-METHODS	The first was the validated consumer-oriented nutrition knowledge scale ( CoNKS ) consisting of 20 true/false items ; the second was an ad hoc questionnaire ( AHQ ) containing 10 questions that would be very difficult for people without health care qualifications to answer correctly .
-METHODS	It therefore aimed at measuring cribbing and not nutrition knowledge .
-METHODS	AHQ items were somewhat encyclopedic and amenable to Web searching , while CoNKS items had more complex wording , so that simple copying/pasting of a question in a search string would not produce an immediate correct answer .
-RESULTS	A total of 72 of the 94 subjects started the survey .
-RESULTS	Dropout rates were similar in both groups ( 11 % , 4/35 and 14 % , 5/37 in the untimed and timed groups , respectively ) .
-RESULTS	Most participants completed the survey from portable devices , such as mobile phones and tablets .
-RESULTS	To complete the survey , participants in the untimed group took a median 2.3 minutes longer than those in the timed group ; the effect size was small ( Cohen 's r = .29 ) .
-RESULTS	Subjects in the untimed group scored significantly higher on CoNKS ( mean difference of 1.2 points , P = .008 ) and the effect size was medium ( Cohen 's d = 0.67 ) .
-RESULTS	By contrast , no significant between-group difference in AHQ scores was documented .
-RESULTS	Unexpectedly high AHQ scores were recorded in 23 % ( 7/31 ) and 19 % ( 6/32 ) untimed and timed respondents , respectively , very probably owing to `` e-cheating '' .
-CONCLUSIONS	Cribbing answers to health knowledge items in researcher-uncontrolled conditions is likely to lead to overestimation of people 's knowledge ; this should be considered during the design and implementation of Web-based surveys .
-CONCLUSIONS	Setting a time limit alone may not completely prevent cheating , as some cheats may be very fast in Web searching .
-CONCLUSIONS	More complex and contextualized wording of items and checking for the `` findability '' properties of items before implementing a Web-based health knowledge survey may discourage help-seeking , thus reducing measurement error .
-CONCLUSIONS	Studies with larger sample sizes and diverse populations are needed to confirm our results .
-
-###24915778
-BACKGROUND	Trametinib , an oral mitogen/extracellular signal-related kinase ( MEK ) 1/2 inhibitor , holds promise for malignancies with rat sarcoma ( RAS ) mutations , like pancreas cancer .
-BACKGROUND	This phase II study was designed to determine overall survival ( OS ) in patients with pancreas cancer treated with trametinib and gemcitabine .
-BACKGROUND	Secondary end-points included progression-free survival ( PFS ) , overall response rate ( ORR ) and duration of response ( DOR ) ; safety end-points were also assessed .
-METHODS	Adults with untreated metastatic adenocarcinoma of the pancreas were randomised ( 1:1 ) to receive intravenous gemcitabine 1000 mg/m ( 2 ) ( weekly 7 for 8 weeks , then days 1 , 8 and 15 of 28-day cycles ) plus trametinib or placebo 2mg daily .
-METHODS	RAS mutations were determined in circulating free DNA ( cfDNA ) and archival tumour tissue .
-METHODS	OS was evaluated in kirsten rat sarcoma viral oncogene homolog ( KRAS ) mutant and wild-type subgroups .
-RESULTS	Baseline characteristics for 160 patients were similar in both treatment arms .
-RESULTS	There was no significant difference in OS ( hazard ratio ( HR ) 0.98 ; 95 % confidence interval ( CI ) , 0.67-1 .44 ; P = .453 ) ; median OS was 8.4 months with gemcitabine plus trametinib and 6.7 months with gemcitabine plus placebo .
-RESULTS	Median PFS ( 16 versus 15 weeks ) , ORR ( 22 % versus 18 % ) and median DOR ( 23.9 versus 16.1 weeks ) were also similar for trametinib and placebo arms , respectively .
-RESULTS	KRAS mutation-positive patients ( n = 103 ) showed no difference in OS between arms .
-RESULTS	Thrombocytopenia , diarrhoea , rash and stomatitis were more frequent with trametinib , as was grade 3 anaemia .
-CONCLUSIONS	The addition of trametinib to gemcitabine did not improve OS , PFS , ORR or DOR in patients with previously untreated metastatic pancreas cancer .
-CONCLUSIONS	Outcomes were independent of KRAS mutations determined by cfDNA .
-
-###26182759
-BACKGROUND	Transurethral resection of prostate ( TURP ) is considered the gold standard for the surgical treatment of BPH .
-BACKGROUND	Irrigant fluid absorption by the patient is a potentially serious complication of TURP and can lead to dilutional hyponatremia and TURP syndrome .
-BACKGROUND	Other common complications of TURP include urinary tract infection and secondary haemorrhage .
-BACKGROUND	The objective of this study was to compare the frequency of postoperative complications ( Urinary Tract infection and dilutional hyponatremia ) between 1.5 % glycine and sterile distilled water used as irrigant in BPH patients after TURP .
-METHODS	This randomized controlled trial was conducted in department of Urology , PIMS Islamabad , from August 2013 to February 2014 .
-METHODS	A total of 170 adult male patients between 50-80 years of age undergoing TURP with prostate volume more than 30cc on ultrasound .
-METHODS	85 patients each were randomly allocated to two groups .
-METHODS	In group-A , glycine was used as irrigan , t solution during TURP while in group-B distilled water was used .
-METHODS	Serum sodium levels were measured at 6th postoperative hour to look for dilutional hyponatremia .
-METHODS	On the 15th postoperative day they were inquired about any clinical features of urinary tract infection .
-METHODS	Also urine routine examination was performed to look for the presence of WBCs in the urine .
-RESULTS	Post-operative dilutional hyponatremia was observed in 13 ( 15.3 % ) patients in Group A and in 10 ( 11.8 % ) patients in group-B .
-RESULTS	The difference between both the groups being nonsignificant ( p-value = 0.501 ) .
-RESULTS	Frequency of postoperative urinary tract infection on 15th postoperative day in group-A was 23 ( 27.1 % ) while in group-B it was 16 ( 18.8 % ) , the difference among both the groups being insignificant ( p-value = 0.202 ) .
-CONCLUSIONS	Although the frequency of postoperative complications like UTI and dilutional hyponatremia was less with sterile distilled water , yet , the difference was statistically not significant .
-
-###24298995
-OBJECTIVE	To compare efficacy and safety of two , once-daily basal insulin formulations [ insulin lispro protamine suspension ( ILPS ) vs. insulin glargine ( glargine ) ] added to oral antihyperglycaemic medications ( OAMs ) and exenatide BID in suboptimally controlled type 2 diabetes ( T2D ) patients .
-METHODS	This 24-week , open-label , multicentre trial randomized patients to bedtime ILPS ( n = 171 ) or glargine ( n = 168 ) .
-METHODS	Non-inferiority of ILPS versus glargine was assessed by comparing the upper limit of 95 % confidence intervals ( CIs ) for change in haemoglobin A1c ( HbA1c ) from baseline to week 24 ( adjusted for baseline HbA1c ) with non-inferiority margin 0.4 % .
-RESULTS	Non-inferiority of ILPS versus glargine was demonstrated : least-squares mean between-treatment difference ( ILPS minus glargine ) ( 95 % CI ) was 0.22 % ( 0.06 , 0.38 ) .
-RESULTS	Mean HbA1c reduction was less for ILPS - versus glargine-treated patients ( -1.160.84 vs. -1.400.97 % , p = 0.008 ) .
-RESULTS	Endpoint HbA1c < 7.0 % was achieved by 53.7 % ( ILPS ) and 61.7 % ( glargine ) ( p = NS ) .
-RESULTS	Overall hypoglycaemia rates ( p = NS ) and severe hypoglycaemia incidence ( p = NS ) were similar .
-RESULTS	Nocturnal hypoglycaemia rate was higher in patients treated with ILPS versus glargine ( p = 0.004 ) .
-RESULTS	Weight gain was similar between groups ( ILPS : 0.273.38 kg ; glargine : 0.663.93 kg , p = NS ) .
-RESULTS	Endpoint total insulin doses were lower in patients treated with ILPS versus glargine ( 0.300.17 vs. 0.370.17 IU/kg/day , p < 0.001 ) .
-CONCLUSIONS	ILPS was non-inferior to glargine for HbA1c change over 24weeks , but was associated with less HbA1c reduction and more nocturnal hypoglycaemia .
-CONCLUSIONS	Treat-to-target basal insulin therapy improves glycaemic control and is associated with minimal weight gain when added to OAMs and exenatide BID for suboptimally controlled T2D .
-
-###24820395
-BACKGROUND	Cerebral blood flow velocity ( CBFV ) measured by transcranial Doppler sonography has provided information on cerebral perfusion in patients undergoing infant heart surgery , but no studies have reported a relationship to early postoperative and long-term neurodevelopmental outcomes .
-METHODS	CBFV was measured in infants undergoing biventricular repair without aortic arch reconstruction as part of a trial of hemodilution during cardiopulmonary bypass ( CPB ) ; CBFV ( Vm , mean ; Vs , systolic ; Vd , end-diastolic ) in the middle cerebral artery and change in Vm ( rVm ) were measured intraoperatively and up to 18 hours post-CPB .
-METHODS	Neurodevelopmental outcomes , measured at 1 year of age , included the psychomotor development index ( PDI ) and mental development index ( MDI ) of the Bayley Scales of Infant Development-II .
-RESULTS	CBFV was measured in 100 infants ; 43 with D-transposition of the great arteries , 36 with tetralogy of Fallot , and 21 with ventricular septal defects .
-RESULTS	Lower Vm , Vs , Vd , and rVm at 18 hours post-CPB were independently related to longer intensive care unit duration of stay ( p < 0.05 ) .
-RESULTS	In the 85 patients who returned for neurodevelopmental testing , lower Vm , Vs , Vd , and rVm at 18 hours post-CPB were independently associated with lower PDI ( p < 0.05 ) and MDI ( p < 0.05 , except Vs : p = 0.06 ) scores .
-RESULTS	Higher Vs and rVm at 18 hours post-CPB were independently associated with increased incidence of brain injury on magnetic resonance imaging in 39 patients .
-CONCLUSIONS	Postoperative CBFV after biventricular repair is related to early postoperative and neurodevelopmental outcomes at 1 year of age , possibly indicating that low CBFV is a marker of suboptimal postoperative hemodynamics and cerebral perfusion .
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-###25212234
-OBJECTIVE	Patients with acute coronary syndromes ( ACS ) display diffuse coronary atheroma instability and heightened risk of early and late recurrent coronary events .
-OBJECTIVE	We compared the long-term antiatherosclerotic efficacy of high-intensity statins in patients with ACS when compared with stable disease .
-RESULTS	Study of Coronary Atheroma by Intravascular Ultrasound : Effect of Rosuvastatin Versus Atorvastatin ( SATURN ) used serial intravascular ultrasound measures of coronary atheroma volume in patients treated with rosuvastatin 40 mg or atorvastatin 80 mg for 24 months .
-RESULTS	The overall effect of high-intensity statins on the change in coronary percent atheroma volume and major adverse cardiovascular events ( death/nonfatal myocardial infarction/coronary revascularization ) were evaluated in this post hoc analysis .
-RESULTS	When compared with non-ACS patients ( n = 678 ) , patients with ACS ( n = 361 ) were younger , actively smoking , and have had a previous myocardial infarction ( all P < 0.001 ) .
-RESULTS	At baseline , patients with ACS exhibited lower high-density lipoprotein cholesterol ( 43.511 versus 45.811 mg/dL ; P = 0.002 ) , a higher apolipoprotein B : apolipoprotein A-1 ratio ( 0.900.24 versus 0.830.24 ; P < 0.001 ) and greater percent atheroma volume ( 37.38.5 % versus 35.98.1 % ; P = 0.01 ) when compared with non-ACS patients .
-RESULTS	Despite similar achieved levels of lipid and inflammatory markers after high-intensity statin therapy , patients with ACS demonstrated greater percent atheroma volume regression than non-ACS patients ( -1.460.14 versus -0.890.13 ; P = 0.003 ) .
-RESULTS	After propensity-weighted multivariable adjustment , baseline percent atheroma volume ( P < 0.001 ) and an ACS clinical presentation ( P = 0.02 ) independently associated with plaque regression .
-RESULTS	The 24-month major adverse cardiovascular events-free survival was similar between patients with ACS and non-ACS ( 90.6 versus 92.9 % ; P = 0.25 ) .
-CONCLUSIONS	Long-term high-intensity statin therapy caused greater plaque regression and comparable major adverse cardiovascular events rates in ACS when compared with non-ACS patients .
-CONCLUSIONS	Despite a higher clinical risk profile , patients with ACS harbor a more modifiable disease substrate and seem to benefit the most from potent statin therapy .
-
-###24963091
-OBJECTIVE	Beside traditional dysphagia therapy , neuromuscular electrical stimulation ( NMES ) has been proposed to treat patients with dysphagia .
-OBJECTIVE	Considering the complexity of the nerve-muscle interaction during swallowing , the underlying physiology of NMES remains unclear .
-OBJECTIVE	Here , we addressed the question of whether NMES can modify upper esophageal sphincter ( UES ) dynamics .
-METHODS	In a prospective study , 26 healthy volunteers performed water swallows with and without NMES .
-METHODS	The stimulus was applied in a participant - and operator-initiated stimulation above , near , and below the motor threshold .
-METHODS	Swallowing parameters were measured using high-resolution manometry .
-RESULTS	The UES relaxation time was found to be extended by 10 % , indicating a modification in UES dynamics .
-CONCLUSIONS	The chosen NMES paradigm influenced the involuntary swallowing phase by extending relaxation time , providing more time for bolus passage into the esophagus .
-CONCLUSIONS	Future studies will have to evaluate if this effect can be found in patients with dysphagia and whether it is beneficial for treatment .
-
-###25216962
-OBJECTIVE	Aim of this prospective study was to investigate the effectiveness of eutectic mixture of local anaesthetic ( EMLA ) patches on every abdominal incision for pain relief after gynaecologic laparoscopic surgery .
-METHODS	A total of 121 women were prospectively randomised to receive either placebo ( control group ) or EMLA ( study group ) patches on all abdominal incisions .
-METHODS	Postoperative pain was assessed 24 and 48 h after surgery using the short form of the McGill Pain Questionnaire ( SF-MPQ ) .
-METHODS	The amount of analgesic pain medication on demand was assessed in both groups .
-RESULTS	Sixty women were allocated to the study group and 61 patients to the control group before laparoscopic surgery .
-RESULTS	There were no statistically significant differences regarding age , body mass index ( BMI ) , duration of surgery and blood loss comparing both groups .
-RESULTS	There were no statistically significant differences between both groups with regard to postoperative total pain scores 24 h ( McGill total score : 31.77 27.95 vs. 36.80 31.39 , p = 0.3535 ) and 48 h ( McGill total score : 19.18 20.09 vs. 26.61 27.70 , p = 0.0942 ) after surgery .
-RESULTS	Time to mobilisation after surgery ( hours ) was significantly shorter in the study group ( 5.01 3.72 vs. 5.78 3.04 , p = 0.0423 ) .
-CONCLUSIONS	Despite of a significant reduction of time for mobilisation transdermal anaesthetic patches after gynaecologic laparoscopic surgery did not lead to decreased postoperative pain scores .
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-###24225356
-BACKGROUND	Haiti has experienced rapid urbanization that has exacerbated poverty and undernutrition in large slum areas .
-BACKGROUND	Stunting affects 1 in 5 young children .
-OBJECTIVE	We aimed to test the efficacy of a daily lipid-based nutrient supplement ( LNS ) for increased linear growth in young children .
-METHODS	Healthy , singleton infants aged 6-11 mo ( n = 589 ) were recruited from an urban slum of Cap Haitien and randomly assigned to receive : 1 ) a control ; 2 ) a 3-mo LNS ; or 3 ) a 6-mo LNS .
-METHODS	The LNS provided 108 kcal and other nutrients including vitamin A , vitamin B-12 , iron , and zinc at 80 % of the recommended amounts .
-METHODS	Infants were followed monthly on growth , morbidity , and developmental outcomes over a 6-mo intervention period and at one additional time point 6 mo postintervention to assess sustained effects .
-METHODS	The Bonferroni multiple comparisons test was applied , and generalized least-squares ( GLS ) regressions with mixed effects was used to examine impacts longitudinally .
-RESULTS	Baseline characteristics did not differ by trial arm except for a higher mean age in the 6-mo LNS group .
-RESULTS	GLS modeling showed LNS supplementation for 6 mo significantly increased the length-for-age z score ( SE ) by 0.13 0.05 and the weight-for-age z score by 0.12 0.02 compared with in the control group after adjustment for child age ( P < 0.001 ) .
-RESULTS	The effects were sustained 6 mo postintervention .
-RESULTS	Morbidity and developmental outcomes did not differ by trial arm .
-CONCLUSIONS	A low-energy , fortified product improved the linear growth of young children in this urban setting .
-CONCLUSIONS	The trial was registered at clinicaltrials.gov as NCT01552512 .
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-###25048382
-OBJECTIVE	Blood pressure ( BP ) control for renal protection is essential for patients with type 2 diabetes .
-OBJECTIVE	Our objective in this analysis of Veterans Affairs Diabetes Trial ( VADT ) data was to learn whether on-study systolic BP ( SBP ) , diastolic BP ( DBP ) , and pulse pressure ( PP ) affected renal outcomes measured as albumin-to-creatinine ratio ( ACR ) and estimated glomerular filtration rate ( eGFR ) .
-METHODS	The VADT was a prospective , randomized study of 1,791 veterans with type 2 diabetes to determine whether intensive glucose control prevented major cardiovascular events .
-METHODS	In this post hoc study , time-varying covariate survival analyses and hazard ratios ( HR ) were used to determine worsening of renal outcomes .
-RESULTS	Compared with SBP 105-129 mmHg , the risk of ACR worsening increased significantly for SBP 130-139 mmHg ( HR 1.88 [ 95 % CI 1.28-2 .77 ] ; P = 0.001 ) and for SBP 140 mmHg ( 2.51 [ 1.66-3 .78 ] ; P < 0.0001 ) .
-RESULTS	Compared with a PP range of 40-49 mmHg , PP < 40 was associated with significantly lowered risk of worsening ACR ( 0.36 [ 0.15-0 .87 ] ; P = 0.022 ) and PP 60 with significantly increased risk ( 2.38 [ 1.58-3 .59 ] ; P < 0.0001 ) .
-RESULTS	Analyses of BP ranges associated with eGFR worsening showed significantly increased risk with rising baseline SBP and an interaction effect between SBP 140 mmHg and on-study A1C .
-RESULTS	These patients were 15 % more likely than those with SBP < 140 mmHg to experience eGFR worsening ( 1.15 [ 1.00-1 .32 ] ; P = 0.045 ) for each 1 % ( 10.9 mmol/mol ) A1C increase .
-CONCLUSIONS	SBP 130 mmHg and PP > 60 mmHg were associated with worsening ACR .
-CONCLUSIONS	The results suggest that treatment of SBP to < 130 mmHg may lessen ACR worsening .
-CONCLUSIONS	The interaction between SBP 140 mmHg and A1C suggests that the effect of glycemic control on reducing progression of renal disease may be greater in hypertensive patients .
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-###25072616
-BACKGROUND	Protease inhibitor-based antiretroviral therapy ( ART ) has been associated with preterm birth in some studies .
-BACKGROUND	We examined risk factors for preterm birth among women randomized to lopinavir/ritonavir ( LPV/r ) - or efavirenz ( EFV ) - based ART .
-METHODS	This was a planned secondary analysis of the PROMOTE-Pregnant Women and Infants Study , an open-label , randomized controlled trial comparing the risk of placental malaria among HIV-infected , ART-naive pregnant Ugandan women assigned to initiate LPV/r - or EFV-based ART at 12-28 weeks gestation .
-METHODS	Gestational age was determined based on last menstrual period and ultrasound biometry .
-METHODS	All women received bednets and trimethoprim-sulfamethoxazole .
-METHODS	Stillbirths , spontaneous abortions , and multiple gestations were excluded from the primary analysis .
-METHODS	Potential risk factors for preterm birth ( < 37 weeks gestation ) were evaluated by univariate and multivariate logistic regression .
-RESULTS	Three hundred fifty-six women were included in this analysis .
-RESULTS	At enrollment , median gestational age was 21 weeks and median CD4 cell count was 368 cells per cubic millimeter .
-RESULTS	14.7 % of deliveries in the EFV arm and 16.2 % in the LPV/r arm were preterm .
-RESULTS	Preterm birth was associated with gestational weight gain below 0.1 kg/week versus 0.1 kg/week or more [ odds ratio ( OR ) = 2.49 ; 95 % confidence interval ( CI ) : 1.38 to 4.47 ; P = 0.003 ] .
-RESULTS	Neither ART regimen of LPV/r versus EFV ( OR = 1.12 ; 95 % CI : 0.63 to 2.00 ; P = 0.69 ) nor placental malaria ( OR = 0.74 ; 95 % CI : 0.38 to 1.44 ; P = 0.37 ) was associated with preterm birth .
-CONCLUSIONS	LPV/r was not associated with an increased risk of preterm birth compared with EFV .
-CONCLUSIONS	However , interventions are needed to address modifiable risk factors for preterm birth , such as nutritional status ( ClinicalTrials.gov , NCT00993031 ) .
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-###24628987
-BACKGROUND	The optimal substrate ablation approach in patients with persistent atrial fibrillation ( Per AF ) remains unclear .
-BACKGROUND	This was a prospective randomized study comparing the efficacy of limited ( continuous complex fractionated atrial electrogram , CFAE : < 60 milliseconds ) versus extensive ( continuous CFAE plus variable CFAE : < 120 milliseconds ) atrial substrate modification in Per AF patients .
-RESULTS	We enrolled 120 Per AF patients in the study , and 30 patients with AF termination after pulmonary vein isolation ( PVI ) were excluded .
-RESULTS	In the remaining 90 patients , 45 were treated with limited approach ( Group 1 ) and 45 with an extensive approach ( Group 2 ) .
-RESULTS	The end point of the study was the incidence of an atrial arrhythmia recurrence postblanking period .
-RESULTS	The patients were followed up for 15 months with 3-month clinical reviews , electrograms ( ECGs ) , Holter recordings , and echocardiographic monitoring .
-RESULTS	Procedural AF termination and the single procedural efficacy were statistically comparable between the 2 groups ( 48.9 % vs. 63.4 % in Groups 1 and 2 , respectively , P = 0.289 ) .
-RESULTS	During the follow-up , patients who received limited ablation had a lower incidence of recurrent AFL ( P = 0.04 ) , and better reverse remodeling of the left atrium ( LA , P = 0.04 ) .
-RESULTS	After 2 procedures , the freedom from any atrial arrhythmia was better in Group 2 ( 62.2 % vs. 87.8 % , P = 0.009 ) .
-RESULTS	Those with longstanding AF and a larger baseline LA size responded better to the extensive ablation .
-CONCLUSIONS	In the Per AF patients who failed to achieve AF termination after PVI alone , a specific atrial substrate modification approach targeting only continuous CFAEs could be considered as an initial ablation strategy .
-
-###25179672
-BACKGROUND	Alcohol misuse among military service members from the recent conflicts in Iraq and Afghanistan is over two times higher compared to misuse in the civilian population .
-BACKGROUND	Unfortunately , in addition to experiencing personal consequences from alcohol misuse , partners and family members of alcohol-misusing service members also suffer in negative ways from their loved one 's drinking .
-BACKGROUND	These family members represent important catalysts for helping their loved ones identify problem drinking and overcoming the barriers to seeking care .
-BACKGROUND	This paper describes the protocol to a pilot study evaluating a 4-session , web-based intervention ( WBI ) for concerned partners ( CPs ) of service members with alcohol misuse .
-METHODS	The WBI will be adapted from the Community Reinforcement and Family Training ( CRAFT ) intervention .
-METHODS	In the first phase , we will develop and beta-test the WBI with 15-20 CPs .
-METHODS	In the second phase , we will randomize CPs to WBI ( n = 50 ) or to delayed-WBI ( n = 50 ) and evaluate the impact of the WBI on CPs ' perceptions of service member help-seeking and drinking , as well as the CP 's well-being and relationship satisfaction 3months after the intervention .
-METHODS	In the third phase , we will recruit 15-20 service members whose partners have completed the study .
-METHODS	We will interview the service members to learn how the CP-focused WBI affected them and to assess whether they would be receptive to a follow-on WBI module to help them .
-CONCLUSIONS	This project has the potential to benefit a large population of military service members who may be disproportionately affected by recent conflicts and whose drinking misuse would otherwise go undetected and untreated .
-CONCLUSIONS	It also develops a new prevention model that does not rely on service members or partners attending a hospital or clinical facility to access care .
-BACKGROUND	NCT02073825 .
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-###25134858
-OBJECTIVE	To identify predictive factors associated with the development of pressure ulcers in patients at risk who receive standardized preventive care .
-BACKGROUND	Numerous studies have examined factors that predict risk for pressure ulcer development .
-BACKGROUND	Only a few studies identified risk factors associated with pressure ulcer development in hospitalized patients receiving standardized preventive care .
-METHODS	Secondary analyses of data collected in a multicentre randomized controlled trial .
-METHODS	The sample consisted of 610 consecutive patients at risk for pressure ulcer development ( Braden Score < 17 ) receiving standardized preventive care measures .
-METHODS	Patient demographic information , data on skin and risk assessment , medical history and diagnosis were collected during 26months ( December 2007-January 2010 ) .
-METHODS	Predictive factors were identified using multivariate statistics .
-RESULTS	Pressure ulcers in category II-IV were significantly associated with non-blanchable erythema , urogenital disorders and higher body temperature .
-RESULTS	Predictive factors significantly associated with superficial pressure ulcers were admission to an internal medicine ward , incontinence-associated dermatitis , non-blanchable erythema and a lower Braden score .
-RESULTS	Superficial sacral pressure ulcers were significantly associated with incontinence-associated dermatitis .
-CONCLUSIONS	Despite the standardized preventive measures they received , hospitalized patients with non-blanchable erythema , urogenital disorders and a higher body temperature were at increased risk for developing pressure ulcers .
-CONCLUSIONS	Improved identification of at-risk patients can be achieved by taking into account specific predictive factors .
-CONCLUSIONS	Even if preventive measures are in place , continuous assessment and tailoring of interventions is necessary in all patients at risk .
-CONCLUSIONS	Daily skin observation can be used to continuously monitor the effectiveness of the intervention .
-
-###24581596
-OBJECTIVE	The use of liver as a reference tissue for semi-quantification of tumour FDG uptake may not be valid in hepatic steatosis ( HS ) .
-OBJECTIVE	Previous studies on the relation between liver FDG uptake and HS have been contradictory probably because they ignored blood glucose ( BG ) .
-OBJECTIVE	Because hepatocyte and blood FDG concentrations equalize , liver FDG uptake parallels BG , which must therefore be considered when studying hepatic FDG uptake .
-OBJECTIVE	We therefore re-examined the relation between HS and liver uptake taking BG into account .
-METHODS	This was a retrospective study of 304 patients undergoing routine PET/CT with imaging 60min post-FDG .
-METHODS	Average standard uptake value ( SUVave ) , maximum SUV ( SUVmax ) and CT density ( index of HS ) were measured in a liver ROI .
-METHODS	Blood pool SUV was based on the left ventricular cavity ( SUVLV ) .
-METHODS	Correlations were assessed using least squares fitting of continuous data .
-METHODS	Patients were also divided into BG subgroups ( < 4 , 4-5 , 5-6 , 6-8 , 8-10 and 10 + mmol/l ) .
-RESULTS	SUVave , SUVmax and SUVLV displayed similar relations with BG .
-RESULTS	SUVmax/SUVLV , but not SUVave/SUVLV , correlated significantly with BG .
-RESULTS	SUVmax , but not SUVave , correlated inversely with CT density before and after adjusting for BG .
-RESULTS	SUVmax/SUVave correlated more strongly with CT density than SUVmax .
-RESULTS	CT density correlated inversely with SUVmax/SUVLV but positively with SUVave/SUVLV .
-CONCLUSIONS	Hepatic SUV is more influenced by BG than by HS .
-CONCLUSIONS	Its relation with BG renders it unsuitable as a reference tissue .
-CONCLUSIONS	Nevertheless , hepatic fat does correlate positively with liver SUV , although this is seen only with SUVmax because SUVave is ` diluted ' by hepatic fat .
-
-###24703415
-OBJECTIVE	To test whether a breakfast including eggs ( EB ) containing high-quality protein decreases subsequent food intake and increases satiety-related hormones in overweight or obese adults more than a breakfast including cereal ( CB ) of lower protein quality , but matched for energy density and macronutrient composition .
-METHODS	Twenty healthy overweight or obese subjects were randomized to eat an EB or a CB daily under supervision for one week , followed by a crossover to the opposite breakfast week after a two-week washout period .
-METHODS	On days 1 and 7 of each test week , a structured lunch was provided ad libitum .
-METHODS	Food intake , hunger and satiety scores , and blood parameters were measured before and after breakfast .
-METHODS	Outcomes were analyzed using mixed effects statistical models for repeated measures analysis of variance .
-RESULTS	Compared to the CB week , during the EB week , a ) feeling of fullness was greater ( P < 0.05 ) on day 1 but not on day 7 ; b ) energy intake was not significantly lower on either day ; c ) right before lunch , acylated ghrelin was lower and PYY3-36 was higher on day 1 ( P < 0.01 and < 0.002 , respectively ) but not on day 7 ; d ) PYY3-36 , but not ghrelin , showed greater rise between breakfast and lunch on days 1 ( P < 0.001 ) and 7 ( P < 0.01 ) .
-CONCLUSIONS	Despite a highly similar energy density and macronutrient composition , the higher protein quality breakfast significantly influenced fullness , ghrelin and PYY3-36 .
-CONCLUSIONS	Only the effect on PYY3-36 lasted throughout the week .
-CONCLUSIONS	A next step would be to test if the benefits are pronounced and lasting , if protein quality of all meals is increased .
-
-###24239210
-BACKGROUND	Neoadjuvant chemotherapy with trastuzumab for patients with HER2-positive breast cancer can produce a pathological complete response in the breast in 30-65 % of patients .
-BACKGROUND	We investigated the effect of the timing of trastuzumab administration with anthracycline and taxane neoadjuvant chemotherapy .
-METHODS	This randomised trial was done at 36 centres in the USA and Puerto Rico .
-METHODS	Women with operable HER2-positive invasive breast cancer were randomly assigned ( 1:1 ) with a biased coin minimisation algorithm , stratified for age , tumour size , and hormone receptor status .
-METHODS	Neither patients nor investigators ( except for a cardiac safety review panel ) were masked to treatment assignment .
-METHODS	Patients randomly assigned to sequential treatment received fluorouracil 500 mg/m ( 2 ) , epirubicin 75 mg/m ( 2 ) , and cyclophosphamide 500 mg/m ( 2 ) ( FEC-75 ) on day 1 of a 21-day cycle for four cycles followed by paclitaxel 80 mg/m ( 2 ) and trastuzumab 2 mg/kg ( after a 4 mg/kg loading dose ) once per week for 12 weeks , while those randomly assigned to the concurrent treatment group received paclitaxel and trastuzumab once per week for 12 weeks followed by four cycles of FEC-75 ( on day 1 of each 21-day cycle ) and once-weekly trastuzumab , in the same doses as the sequential group .
-METHODS	Surgery , including evaluation of the axilla , was done within 6 weeks of completion of neoadjuvant treatment .
-METHODS	The primary outcome was the percentage of patients who had a pathological complete response in the intention-to-treat population .
-METHODS	The study is registered with ClinicalTrials.gov , number NCT00513292 .
-RESULTS	From Sept 15 , 2007 , to Dec 15 , 2011 , 282 women were enrolled ( 140 in the sequential group , 142 in the concurrent group ) .
-RESULTS	Two patients in the sequential group withdrew consent before starting treatment .
-RESULTS	78 of 138 ( 565 % , 95 % CI 478-649 ) patients who received sequential treatment had a pathological complete response in the breast versus 77 of 142 ( 542 % , 95 % CI 457-626 ) who received concurrent treatment ( difference 23 % , 95 % CI -93 to 139 ) .
-RESULTS	No treatment-related deaths occurred .
-RESULTS	The most common severe toxic effects were neutropenia ( 35 [ 253 % ] of 138 patients in the sequential group vs 45 [ 317 % ] of 142 patients in the concurrent group ) and fatigue ( six [ 43 % ] vs 12 [ 85 % ] ) .
-RESULTS	Left ventricular ejection fraction dropped below the institutional lower limit of normal at week 12 in one ( 08 % ) of 130 patients who received sequential treatment and four ( 29 % ) of 137 patients who received concurrent treatment ; by week 24 , it had dropped below this limit in nine ( 71 % ) of 126 patients and in six ( 46 % ) of 130 patients , respectively .
-CONCLUSIONS	Concurrent administration of trastuzumab with anthracyclines offers no additional benefit and is not warranted .
-BACKGROUND	US National Cancer Institute .
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-###24377213
-OBJECTIVE	To compare the difference of the efficacy on knee osteoarthritis ( KOA ) between the combined therapy of acupuncture and moxibustion and western medication , and explore the better therapeutic method for KOA .
-METHODS	One hundred and sixty patients were divided into a combined therapy group and a western medication group , 80 cases in each one according to the visit sequence , with the random number table adopted .
-METHODS	In the combined therapy group , the main points were selected from the local painful sites , combined with the acupoints based on the syndrome differentiation and distal acupoints on the affected meridians .
-METHODS	The lifting , thrusting or rotating technique was used and the reinforcing or reducing manipulation was applied according to the syndrome differentiation .
-METHODS	`` Duanci '' or `` Shuci '' needling technique was used specially at the extra points and Ashi points .
-METHODS	The needling sensation relied on the patients ' tolerance .
-METHODS	After acupuncture , the heat-sensitive moxibustion with pure moxa stick was applied over the local painful sites around knee joint and Shenshu ( BL 23 ) to detect the heat-sensitized points .
-METHODS	Acupuncture and moxibustion were given once every day .
-METHODS	The treatment of 5 days made 1 session .
-METHODS	There were 2 days at the interval between two sessions .
-METHODS	In the western medication group , glucosamine sulfate capsules were prescribed for oral administration , 2 capsules each time , three times a day .
-METHODS	Additionally , the joint cavity injection was combined .
-METHODS	On the first day , sodium hyaluronate 25 mg and triamcinolone acetonide acetate 50 mg were injected .
-METHODS	Afterwards , on the 8th , 15th , 22nd and 29th days , sodium hyaluronate injection 25 mg was used only .
-METHODS	The treatment was for 5 weeks totally in the two groups .
-METHODS	The efficacy was analyzed statistically in 5 weeks .
-METHODS	The follow-up visit was conducted in 3 months and 6 months after 5 weeks treatment , respectively .
-METHODS	The Western Ontario and Mcmaster Universities Osteoarthritis Index ( WOMAC ) and visual analogue scale ( VAS ) were adopted to assess the recovery of joint function .
-RESULTS	The efficacy in 5 weeks of treatment was different significantly between the two groups ( P < 0.05 ) .
-RESULTS	The efficacy in the western medication group was better than that in the combined therapy group .
-RESULTS	The difference in the safety assessment was remarkable ( P < 0.01 ) .
-RESULTS	The result in the combined therapy group was superior remarkably to the western medication group .
-RESULTS	In 3-month follow-up visit after treatment , the knee joint function was not different obviously between the two groups ( P > 0.05 ) .
-RESULTS	In 6-month followup visit after treatment , the knee joint function was different obviously between the two groups ( P < 0.01 ) .
-RESULTS	The result in the combined therapy group was better remarkably than that in the western medication group .
-CONCLUSIONS	The combined therapy of acupuncture and moxibustion achieves the safe and effective therapeutic effect with less adverse reactions in the treatment of KOA .
-CONCLUSIONS	The immediate effect in the combined therapy group is not so obvious as compared with the western medication , but the long-term efficacy is remarkably superior to western medication .
-
-###25818495
-BACKGROUND	The prognostic value of time from symptom onset to reperfusion may be enhanced by the identification of Q waves on the presenting electrocardiogram ( ECG ) in patients with ST-segment elevation myocardial infarction ( STEMI ) .
-BACKGROUND	We evaluated whether the relative prognostic utility of these 2 metrics was altered by sex .
-METHODS	Q waves in the distribution of the ST-segment elevation on the baseline ECG were evaluated by a blinded core laboratory in 2838 STEMI patients ( 2163 men and 675 women ) from the PLATelet inhibition and patient Outcomes ( PLATO ) trial who underwent percutaneous coronary intervention ( PCI ) within 12 hours of symptom onset .
-RESULTS	Women were older ( median 63 vs 57 years ) , more likely to be diabetic ( 24.1 % vs 15.5 % ) , hypertensive ( 69.2 % vs 50.9 % ) , and a higher Killip class > I ( 8.6 % vs 5.9 % ) , as compared with men .
-RESULTS	Whereas the Q waves frequency rose progressively over time to ECG in men , this relationship was attenuated in women ( P = .057 ) .
-RESULTS	Q waves on the baseline ECG were associated with a higher excess hazard of 1-year vascular death in men ( hazard ratio [ HR ] 2.03 ; 95 % confidence interval [ CI ] , 1.13-3 .72 ) , and a similar trend existed in women ( HR 1.97 ; 95 % CI , 0.86-4 .51 ) .
-RESULTS	Women with baseline Q waves tended to have higher risk of 1-year vascular death than men as continuous time from symptom onset to PCI increased ( P [ interaction ] = .182 ) .
-CONCLUSIONS	These differences in the evolution of baseline Q waves and relationship between time from symptom onset and vascular death in women and men deserve recognition in future studies of STEMI .
-
-###25073486
-BACKGROUND	In many countries a high proportion of births begin as induced labours .
-BACKGROUND	Induction can be lengthy if cervical priming is required prior to induction .
-BACKGROUND	This usually occurs as an inpatient , however , an alternative is to allow women to go home after satisfactory fetal monitoring .
-BACKGROUND	The aim of this study was to assess the preferences of women for cervical priming for induction of labour in an outpatient or inpatient setting .
-METHODS	A discrete choice experiment ( DCE ) was conducted alongside a randomised trial of inpatient and outpatient cervical priming ( the OPRA trial ) in two maternity hospitals in South Australia .
-METHODS	362 participants were included , and women 's preferences for cervical priming for induction of labour were assessed .
-RESULTS	Women were willing to accept an extra 1.4 trips to hospital ( 2.4 trips total ) and a total travel time of 73.3 minutes to be able to return to their own home while waiting for the priming to work .
-RESULTS	For enhanced inpatient services , women were willing to accept a total travel time of 54.7 minutes to have a private room with private bathroom while waiting for the priming to work .
-RESULTS	The overall benefit score for outpatient priming was 3.63 , 3.59 for enhanced inpatient care and 2.89 for basic inpatient care , suggesting slightly greater preferences for outpatient priming .
-RESULTS	Preferences for outpatient priming increased when women could return to their own home ( compared to other offsite accommodation ) , and decreased with more trips to hospital and longer travel time .
-CONCLUSIONS	Our results suggest that outpatient priming was slightly more preferred than either enhanced inpatient priming or basic care ; these results should be confirmed in different clinical settings .
-CONCLUSIONS	There may be merit in providing women information about both options in the future , as preferences varied according to the characteristics of the services on offer and the sociodemographic background of the woman .
-
-###25358450
-OBJECTIVE	Tesamorelin is a synthetic analogue of growth hormone-releasing factor ( GRF ) , which increases basal and pulsatile growth hormone ( GH ) secretion and subsequently increases insulin-like growth factor ( IGF ) -1 .
-OBJECTIVE	Limited information is available about the pharmacokinetics of this compound .
-OBJECTIVE	Consequently , the aim of this study was to characterize the population pharmacokinetics of tesamorelin in HIV-infected patients and healthy subjects .
-METHODS	A total of 38 HIV-infected patients and healthy subjects receiving subcutaneous tesamorelin doses of 1 or 2mg administered daily during 14 consecutive days were included in the analysis .
-METHODS	An open one-compartment model with first - and zero-order absorption and first-order elimination was developed to best describe the data using NONMEM ( ) VII .
-METHODS	The effect of different covariates on tesamorelin pharmacokinetics was investigated .
-METHODS	Model evaluation was performed using predictive checks and non-parametric bootstrap .
-RESULTS	Plasma clearance and its interindividual variability [ % coefficient of variation ( CV ) ] was estimated to be 1,060 L/h ( 33.6 % ) .
-RESULTS	Volume of distribution was calculated to be 200L ( 17.7 % ) .
-RESULTS	Age , body size measures , race and health status were not related to tesamorelin pharmacokinetic parameters within the range of covariates studied .
-RESULTS	The fraction of tesamorelin absorbed by a first-order process is 13.1 % higher on day 14 compared with day 1 .
-RESULTS	Predictive checks and non-parametric bootstrap demonstrated that the model is appropriate in describing the time course of tesamorelin plasma concentrations in both HIV-infected patients and healthy subjects .
-CONCLUSIONS	An open one-compartment model with first and zero order absorption processes and linear elimination is suitable to characterize the pharmacokinetics of tesamorelin .
-CONCLUSIONS	The fraction of tesamorelin absorbed by a first-order process evolves with time .
-CONCLUSIONS	No clinically relevant covariates were identified as predictors of tesamorelin pharmacokinetics .
-
-###25975474
-BACKGROUND	Neuron-specific enolase ( NSE ) is a widely-used biomarker for prognostication of neurological outcome after cardiac arrest , but the relevance of recommended cutoff values has been questioned due to the lack of a standardized methodology and uncertainties over the influence of temperature management .
-OBJECTIVE	This study investigated the role of NSE as a prognostic marker of outcome after out-of-hospital cardiac arrest ( OHCA ) in a contemporary setting .
-METHODS	A total of 686 patients hospitalized after OHCA were randomized to targeted temperature management at either 33C or 36C .
-METHODS	NSE levels were assessed in blood samples obtained 24 , 48 , and 72 h after return of spontaneous circulation .
-METHODS	The primary outcome was neurological outcome at 6 months using the cerebral performance category score .
-RESULTS	NSE was a robust predictor of neurological outcome in a baseline variable-adjusted model , and target temperature did not significantly affect NSE values .
-RESULTS	Median NSE values were 18 ng/ml versus 35 ng/ml , 15 ng/ml versus 61 ng/ml , and 12 ng/ml versus 54 ng/ml for good versus poor outcome at 24 , 48 , and 72 h , respectively ( p < 0.001 ) .
-RESULTS	At 48 and 72 h , NSE predicted neurological outcome with areas under the receiver-operating curve of 0.85 and 0.86 , respectively .
-RESULTS	High NSE cutoff values with false positive rates 5 % and tight 95 % confidence intervals were able to reliably predict outcome .
-CONCLUSIONS	High , serial NSE values are strong predictors of poor outcome after OHCA .
-CONCLUSIONS	Targeted temperature management at 33C or 36C does not significantly affect NSE levels .
-CONCLUSIONS	( Target Temperature Management After Cardiac Arrest [ TTM ] ; NCT01020916 ) .
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-###24969395
-BACKGROUND	Physical activity ( PA ) has documented health benefits , but older Latinos are less likely to engage in leisure time PA than older non-Latino whites .
-BACKGROUND	Dance holds a promise as a culturally appropriate form of PA that challenges individuals physically and cognitively .
-BACKGROUND	This paper describes a randomized controlled trial that will test the efficacy of BAILAMOS , a 4-month Latin dance program followed by a 4-month maintenance program , for improving lifestyle PA and health outcomes .
-METHODS	Older adults ( n = 332 ) , aged 55 + , Latino/Hispanic , Spanish speaking , with low PA levels , and at risk for disability will be randomized to one of two programs , a dance program or health education control group .
-METHODS	BAILAMOS is a 4-month program that meets two times per week for one 1h per session .
-METHODS	Dance sessions focus on instruction , including four styles of dance , and couples dancing .
-METHODS	Bi-monthly Fiestas de Baile ( dance parties ) are also included , in which participants dance and practice what they have learned .
-METHODS	Monthly 1-hour discussion sessions utilize a Social Cognitive framework and focus on knowledge , social support , and self-efficacy to increase lifestyle PA. .
-METHODS	The health education control group will meet one time per week for two 2h per session .
-RESULTS	Primary outcomes including PA changes and secondary outcomes including self-efficacy , physical function , cognitive function , and disability will be assessed at baseline , 4 , and 8 months .
-RESULTS	It is hypothesized that PA , self-efficacy , physical function , cognitive function , and functional limitations and disability scores will be significantly better in the BAILAMOS group at 4 and 8 months compared to the control group .
-
-###25633911
-BACKGROUND	The purpose of this study was to evaluate the influence of an early cardiac rehabilitation ( CR ) program on health-related quality of life ( HRQL ) and functional capacity in patients who recently experienced an acute myocardial infarction ( AMI ) .
-BACKGROUND	This program was initiated in the inpatient setting and was followed by an unsupervised outpatient intervention .
-METHODS	After the same inpatient care plan , low-risk patients who experienced an AMI were randomized into 2 groups : ( 1 ) a control group ( CG ) ( n = 43 ) entailing usual care and ( 2 ) an intervention group ( IG ) ( n = 45 ) entailing outpatient ( unsupervised ) CR primarily centered on a progressive walking program .
-METHODS	Initially , all patients underwent a supervised exercise program with early mobilization beginning 12hours after an AMI .
-METHODS	On hospital discharge , all patients were classified according to cardiovascular risk .
-METHODS	Quality of life was evaluated by the MacNew Heart Disease HRQL questionnaire 30 days after discharge .
-METHODS	Functional capacity was determined by a 6-minute walk test ( 6MWT ) distance on the day of inpatient discharge as well as 30 days afterward .
-RESULTS	The HRQL global score was higher in the IG compared with the CG 30 days after discharge ( P < 0.001 ) ; physical and emotional domain scores were both significantly higher in the IG ( P < 0.001 ) .
-RESULTS	Furthermore , the IG showed a greater 6MWT distance compared with the CG ( P < 0.001 ) .
-CONCLUSIONS	A CR program based on early progressive exercises , initiated by supervised inpatient training and followed by an unsupervised outpatient program , improved HRQL and functional capacity in patients at low cardiovascular risk who recently experienced an AMI .
-
-###25024629
-OBJECTIVE	To determine the dose-related effects of a novel probiotic combination , I. 31 , on irritable bowel syndrome ( IBS ) - related quality of life ( IBS-QoL ) .
-METHODS	A multicenter , randomized , double-blind , placebo-controlled intervention clinical trial with three parallel arms was designed .
-METHODS	A total of 84 patients ( 53 female , 31 male ; age range 20-70 years ) with IBS and diarrhea according to Rome-III criteria were randomly allocated to receive one capsule a day for 6 wk containing : ( 1 ) I. 31 high dose ( n = 28 ) ; ( 2 ) I. 31 low dose ( n = 27 ) ; and ( 3 ) placebo ( n = 29 ) .
-METHODS	At baseline , and 3 and 6 wk of treatment , patients filled the IBSQoL , Visceral Sensitivity Index ( VSI ) , and global symptom relief questionnaires .
-RESULTS	During treatment , IBS-QoL increased in all groups , but this increment was significantly larger in patients treated with I. 31 than in those receiving placebo ( P = 0.008 ) .
-RESULTS	After 6 wk of treatment , IBS-QoL increased by 18 3 and 22 4 points in the high and the low dose groups , respectively ( P = 0.041 and P = 0.023 vs placebo ) , but only 9 3 in the placebo group .
-RESULTS	Gut-specific anxiety , as measured with VSI , also showed a significantly greater improvement after 6 wk of treatment in patients treated with probiotics ( by 10 2 and 14 2 points , high and low dose respectively , P < 0.05 for both vs 7 1 score increment in placebo ) .
-RESULTS	Symptom relief showed no significant changes between groups .
-RESULTS	No adverse drug reactions were reported following the consumption of probiotic or placebo capsules .
-CONCLUSIONS	A new combination of three different probiotic bacteria was superior to placebo in improving IBS-related quality of life in patients with IBS and diarrhea .
-
-###24299323
-BACKGROUND	Pantoprazole magnesium ( pantoprazole-Mg ) may display extended inhibition of the proton pump with the potential for improved clinical efficacy in gastro-oesophageal reflux disease ( GERD ) .
-OBJECTIVE	To compare the efficacy of pantoprazole-Mg and esomeprazole in GERD .
-METHODS	Gastro-oesophageal reflux disease ( Los Angeles grades A-D ) patients were randomised to 4weeks of treatment with pantoprazole-Mg ( n = 290 ) or esomeprazole ( n = 288 ) , both 40mg once daily , in this multicentre ( 14 Brazilian sites in 9 cities ) , double-blind study , with an additional 4weeks ' treatment in nonresponding patients .
-METHODS	Severity of oesophagitis ( at endoscopy ) and GERD-related symptoms ( ReQuest-GI ) were assessed .
-METHODS	The primary end point was the proportion of patients in complete remission ( ReQuest-GI score < 1.73 plus endoscopic healing ) at week 4 .
-RESULTS	Complete remission occurred in 61 % of patients in each treatment group at 4weeks ( primary endpoint ) and in 81 % and 79 % of patients in the pantoprazole-Mg and esomeprazole groups at 8weeks , with no significant differences .
-RESULTS	Mucosal healing rates were high and not significantly different .
-RESULTS	At 8weeks , symptom relief with pantoprazole-Mg was significantly greater than that with esomeprazole ( 91.6 % vs. 86.0 % , P = 0.0370 ) because of continued improvement in symptoms with pantoprazole-Mg from week 4 to week 8 ( P = 0.0206 ) .
-CONCLUSIONS	Pantoprazole-Mg 40mg was at least as effective as esomeprazole 40mg for complete remission and the mucosal healing rate was high .
-CONCLUSIONS	Symptom relief with pantoprazole-Mg continued to improve from 4 to 8weeks and was greater than that with esomeprazole at week 8 , suggesting an extended period of treatment effect ( ClinicalTrials.gov identifier : NCT01132638 ) .
-
-###25469520
-BACKGROUND	Retaining HIV patients in medical care promotes access to antiretroviral therapy , viral load suppression , and reduced HIV transmission to partners .
-BACKGROUND	We estimate the programmatic costs of a US multisite randomized controlled trial of an intervention to retain HIV patients in care .
-METHODS	Six academically affiliated HIV clinics randomized patients to intervention ( enhanced personal contact with patients across time coupled with basic HIV education ) and control [ standard of care ( SOC ) ] arms .
-METHODS	Retention in care was defined as 4-month visit constancy , that is , at least 1 primary care visit in each 4-month interval over a 12-month period .
-METHODS	We used microcosting methods to collect unit costs and measure the quantity of resources used to implement the intervention in each clinic .
-METHODS	All fixed and variable labor and nonlabor costs of the intervention were included .
-RESULTS	Visit constancy was achieved by 45.7 % ( 280/613 ) of patients in the SOC arm and by 55.8 % ( 343/615 ) of patients in the intervention arm , representing an increase of 63 patients ( relative improvement 22.1 % ; 95 % confidence interval : 9 % to 36 % ; P < 0.01 ) .
-RESULTS	The total annual cost of the intervention at the 6 clinics was $ 241,565 , the average cost per patient was $ 393 , and the estimated cost per additional patient retained in care beyond SOC was $ 3834 .
-CONCLUSIONS	Our analyses showed that a retention in care intervention consisting of enhanced personal contact coupled with basic HIV education may be delivered at fairly low cost .
-CONCLUSIONS	These results provide useful information for guiding decisions about planning or scaling-up retention in care interventions for HIV-infected patients .
-
-###24405796
-OBJECTIVE	Although previous studies have demonstrated that a variety of local anesthetics are effective to decrease pain associated with tenaculum placement , no studies directly compare an injection with a topical anesthetic .
-OBJECTIVE	The objective of this study was therefore to compare mean pain scores with tenaculum placement after an intracervical lidocaine injection or topical lidocaine gel .
-METHODS	A randomized , single-blinded trial of women presenting for office gynecologic procedures that required a tenaculum .
-METHODS	Women aged 18 years or older were randomized to receive either a 1 % lidocaine intracervical injection or topical application of 2 % lidocaine gel to the cervix immediately prior to tenaculum placement .
-METHODS	The primary outcome was pain at the time of tenaculum placement , measured on a 100 mm Visual Analog Scale .
-METHODS	Secondary outcomes included pain with the intervention and satisfaction with tenaculum placement .
-RESULTS	Seventy-four women were enrolled and randomized ; 35 subjects in each group met criteria for analysis .
-RESULTS	The two groups had similar socio-demographic characteristics .
-RESULTS	Women who received the injection had lower mean pain levels at tenaculum placement [ 12.3 mm ( S.D. 17.4 mm ) versus 36.6 mm ( S.D. 23.0 mm ) , p < .001 ] but higher mean pain levels with study drug application [ 20.4 mm ( S.D. 19.4 mm ) versus 5.9 mm ( S.D. 8.6 mm ) , p < .001 ] .
-RESULTS	Satisfaction with tenaculum placement was similar for the two groups .
-CONCLUSIONS	Mean pain with tenaculum placement is lower after receiving a lidocaine injection than after receiving a topical lidocaine gel .
-CONCLUSIONS	Satisfaction with tenaculum placement is similar with both interventions .
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-###25270861
-BACKGROUND	Over 16000 mastectomies are performed in England and Wales annually .
-BACKGROUND	Acute postoperative pain and nausea are common .
-BACKGROUND	The most frequently occurring long-term complications are chronic pain ( up to 50 % ) and reduced shoulder function ( reported at 35 % ) .
-BACKGROUND	Regional techniques that improve acute postoperative pain relief may reduce the incidence of these complications .
-BACKGROUND	This study assesses the effectiveness of a 24-hour continuous local anaesthetic in the subpectoral plane in improving postoperative pain and quality of life in patients undergoing mastectomy .
-METHODS	This is a randomised , double blind , placebo-controlled , two-centre , parallel group trial in women undergoing mastectomy with or without axillary involvement .
-METHODS	One hundred and sixty participants will be randomised in a 1:1 ratio to receive either 0.25 % levobupivacaine or 0.9 % saline by subpectoral infusion postoperatively for 24h .
-METHODS	All participants will be provided with an intravenous morphine patient-controlled analgesia ( PCA ) system .
-METHODS	Participants will be followed-up for 24h in hospital and at approximately 14days and 6months postoperatively .
-METHODS	Joint primary outcome measures are total morphine consumption and total pain score ( captured via patient-recorded visual analogue scale ( VAS ) 4 hourly ) during the first 24h postoperatively .
-METHODS	Primary statistical analysis of total pain is based on the area under the curve of pain versus time graph .
-METHODS	Secondary outcomes include PCA attempts in first 24h ; VAS pain scores and shoulder function by goniometry at 24h , 14days ( approximately ) and 6months ; Verbal Rating Scale pain scores in first 24h ; Brief Pain Inventory and Oxford Shoulder Score at 6months ; duration of hospital stay ; incidence of postoperative nausea and vomiting ; cost-effectiveness .
-BACKGROUND	The study is approved by the South West England Research Ethics Committee ( 12/SW/0149 ) .
-RESULTS	will be published in a peer-reviewed journal and presented at local , national and international scientific meetings .
-BACKGROUND	ISRCTN46621916 .
-BACKGROUND	EudraCT 2011-005775-16 .
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-###25118091
-BACKGROUND	Case conferences for people with dementia and challenging behaviors ( e.g. , apathy ) are recommended as useful tools that enable staff in nursing homes to understand the behavior of people with this type of disease .
-BACKGROUND	Understanding peoples ' behaviors is the basis for the initiation of targeted interventions to improve the quality of care for people with dementia .
-BACKGROUND	Furthermore , case conferences demonstrate positive effects on burnout , dementia-specific burden , and vocational action competence of the staff .
-BACKGROUND	The two likely approaches for conducting case conferences include the following : A ) using a structured assessment instrument , which guides the staff in understanding the residents ' behaviors and B ) using a narrative approach in which the staff must identify the reasons for the residents ' behaviors in an unstructured manner .
-BACKGROUND	Case conferences are a complex intervention , and evaluating their multiple effects is challenging .
-BACKGROUND	The aim of this study protocol was to describe a likely solution for evaluating this type of complex intervention using a special cluster randomized trial .
-METHODS	In this stepped-wedged cluster randomized trial , the two interventions will be sequentially implemented every three months in a group of 12 nursing homes ( clusters ) with a minimum of 360 residents over 19months ( 7months of intervention for each cluster and follow-up ) .
-METHODS	The primary outcome is the reduction of challenging behavior ( measured with the neuropsychiatric inventory-nursing home version [ NPI-NH ] ) .
-METHODS	Secondary outcomes are residents ' quality of life , prescription of psychotropic medications , staff burnout , dementia-related stress , and vocational action competence .
-METHODS	The effectiveness of the study will be accompanied by a process evaluation .
-METHODS	The primary data will be analyzed using a Bayesian mixed effect model ; the secondary data will be analyzed using descriptive statistics and mixed effects models .
-CONCLUSIONS	The implementation and effect measurement of complex interventions such as case conferences within a cluster randomized trial are challenging ( e.g. , complex and intensive training , delayed treatment effect ) .
-CONCLUSIONS	In this study protocol , the methodological advantages and disadvantages of using the stepped wedge design to answer the research questions are discussed .
-BACKGROUND	http://www.controlled-trials.com/ISRCTN20203855; registered 10 July 2013 .
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-###24592984
-BACKGROUND	Owing to their potential to act as estrogen receptor modulators and interfere with aromatase enzyme in animal studies , phytoestrogens ( PE ) may be useful as part of ovulation induction for polycystic ovary syndrome ( PCOS ) .
-METHODS	Patients < 35 years , presenting with infertility and PCOS , were included and randomly allocated to either group I ( clomiphene citrate ; CC ) or group II ( CC plus Cimicifugae racemosae ; CR ) .
-METHODS	Primary outcome was pregnancy rate .
-METHODS	Secondary outcomes included ovulation , midcycle serum estradiol and luteinizing hormone ( LH ) as well as mid-luteal serum progesterone .
-RESULTS	Analysis included 98 patients in group I versus 96 patients in group II .
-RESULTS	Both groups were matched regarding demographics and basic data .
-RESULTS	Significant differences were elicited when comparing days until HCG injection ( 15.0 1.7 versus 12.0 1.9 , p = 0.91 ) , endometrial thickness ( mm ) ( 8.5 1.9 versus 12.5 1.9 , p < 0.001 ) , serum levels of mid-luteal and midcycle estradiol ( p < 0.001 ; Figure 2 ) , LH ( IU/ml ) ( p < 0.001 ) as well as mid-luteal progesterone ( p < 0.001 ) .
-RESULTS	PE plus CC group had significantly higher clinical pregnancies per cycle ( 33/192 ( 17.2 % ) versus 71/204 ( 34.8 % ) , p < 0.01 ) , compared to the CC only group .
-CONCLUSIONS	Adding CR to clomiphene-induction cycles with timed intercourse in polycystic ovarian syndrome improves cycle outcomes and pregnancy rates .
-
-###25461822
-OBJECTIVE	To compare response to upper-limb treatment using robotics plus motor learning ( ML ) versus functional electrical stimulation ( FES ) plus ML versus ML alone , according to a measure of complex functional everyday tasks for chronic , severely impaired stroke survivors .
-METHODS	Single-blind , randomized trial .
-METHODS	Medical center .
-METHODS	Enrolled subjects ( N = 39 ) were > 1 year postsingle stroke ( attrition rate = 10 % ; 35 completed the study ) .
-METHODS	All groups received treatment 5d/wk for 5h/d ( 60 sessions ) , with unique treatment as follows : ML alone ( n = 11 ) ( 5h/d partial - and whole-task practice of complex functional tasks ) , robotics plus ML ( n = 12 ) ( 3.5 h/d of ML and 1.5 h/d of shoulder/elbow robotics ) , and FES plus ML ( n = 12 ) ( 3.5 h/d of ML and 1.5 h/d of FES wrist/hand coordination training ) .
-METHODS	Primary measure : Arm Motor Ability Test ( AMAT ) , with 13 complex functional tasks ; secondary measure : upper-limb Fugl-Meyer coordination scale ( FM ) .
-RESULTS	There was no significant difference found in treatment response across groups ( AMAT : P. 584 ; FM coordination : P. 590 ) .
-RESULTS	All 3 treatment groups demonstrated clinically and statistically significant improvement in response to treatment ( AMAT and FM coordination : P. 009 ) .
-RESULTS	A group treatment paradigm of 1:3 ( therapist/patient ) ratio proved feasible for provision of the intensive treatment .
-RESULTS	No adverse effects .
-CONCLUSIONS	Severely impaired stroke survivors with persistent ( > 1y ) upper-extremity dysfunction can make clinically and statistically significant gains in coordination and functional task performance in response to robotics plus ML , FES plus ML , and ML alone in an intensive and long-duration intervention ; no group differences were found .
-CONCLUSIONS	Additional studies are warranted to determine the effectiveness of these methods in the clinical setting .
-
-###24686107
-BACKGROUND	The IMMEDIATE ( Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care ) Trial , a randomized controlled double-blind clinical effectiveness trial of glucose-insulin-potassium ( GIK ) administered in ambulances in the out-of-hospital setting , used the Exception from Informed Consent Requirements ( EFIC ) for Emergency Research under Title 21 of the Code of Federal Regulations .
-BACKGROUND	EFIC requirements include community consultation that typically involves using a variety of communication methods and venues to inform the public of the research and to receive their feedback .
-BACKGROUND	Although not the primary purpose of the community consultation process , a common concern to research sponsors , staff , and institutional review boards ( IRBs ) is whether there will be a sufficient number of participants to justify mounting a study in their community .
-BACKGROUND	Information from community consultation regarding the community acceptance might inform this question .
-OBJECTIVE	We evaluated the utility of telephone survey data done as part of the EFIC process as a way to project the ultimate rate of trial participant enrollment .
-METHODS	A telephone survey community consultation process was undertaken in nine communities planning to be IMMEDIATE Trial sites using a representative sampling of the target population in the areas covered by participating emergency medical service ( EMS ) agencies .
-METHODS	Survey respondents were read a description of the planned study and its informed consent approach that included the option for patients to decline participation in the trial while being transported for acute care in an ambulance .
-METHODS	Survey respondents were then asked whether they would object to participating in the study .
-METHODS	At the conclusion of actual trial enrollment , the Coordinating Center compared the survey results with the actual rates of enrollment at each site .
-RESULTS	Approximately 200 ( range = 200-271 ) respondents completed the survey in each of the study communities .
-RESULTS	Of 2079 survey respondents , 68 % ( range = 61 % -75 % ) said that they would not object to participating in the trial if experiencing a heart attack , and 85 % ( range = 79 % -89 % ) said that they would allow the study to be done in their community .
-RESULTS	During actual trial enrollment in the communities , 79 % ( range = 63 % -91 % ) of the 828 potential participants agreed in the ambulance to have the study drug started and provided informed consent at the hospital , an average of 13 percentage-points higher than projected by the survey ( 95 % confidence interval ( CI ) : 9 % -17 % ) , 19 % higher on a relative scale ( CI : 14 % -25 % ) .
-CONCLUSIONS	The survey-based approach to community consultation proved to be an efficient way to obtain representative input from potential clinical trial participants .
-CONCLUSIONS	The survey data generated a relatively good and conservative estimate of the ultimate rate of trial enrollment .
-CONCLUSIONS	This information could be useful to investigators and IRBs in projecting enrollment for clinical trials using EFIC .
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-###24946625
-OBJECTIVE	To verify the clinical efficacy of acupuncture on motor dysfunction in ischemic stroke of subacute stage .
-METHODS	The multi-central randomized controlled trial was adopted .
-METHODS	One hundred and twenty-six cases of ischemic stroke of subacute stage were randomized into an acupuncture group ( 61 cases ) and a conventional treatment group ( 65 cases ) .
-METHODS	The basic treatment of western internal medicine and rehabilitation training were applied to the patients of the two groups .
-METHODS	In the acupuncture group , acupuncture was supplemented at the body points located on the extensor of the upper limbs and the flexor of the lower limbs .
-METHODS	In combination , scalp acupuncture was applied to NS5 , MS6 and MS6 on the affected side .
-METHODS	The treatment was given 5 times a week and totally 8 weeks were required .
-METHODS	The follow-up observation lasted for 3 months .
-METHODS	The scores in Fugl-Meyer scale and NIHSS scale and Barthel index were compared between the two groups before treatment , in 4 and 8 weeks of treatment and the 3-month follow-up observation after treatment separately .
-RESULTS	In 4 and 8 weeks of treatment and the follow-up observation , Fugl-Meyer scale score was improved obviously in the patients of the two groups ( all P < 0.01 ) .
-RESULTS	In 8 weeks of treatment and the follow-up observation , Fugl-Meyer scale score in the acupuncture groupwas im proved much apparently as compared with that in the conventional treatment group [ 68.0 ( 43.0,86.5 ) vs 52.5 ( 30.3 , 77.0 ) , 77.0 ( 49.5 , 89.0 ) vs 63.0 ( 33.0 , 84.0 ) , both P < 0.05 ] .
-RESULTS	Except that NIHSS scale score was not reduced apparently in 4 weeks of treatment in the conventional treatment group ( P > 0.05 ) , the results of NIHSS scale at the other time points were all decreased obviously as compared with those before treatment in the patients of the two groups ( all P < 0.01 ) .
-RESULTS	In 8 weeks of treatment and the follow-up observation , the results in the acupuncture group were reduced much apparently as compared with those in the conventional treatment group [ 5.0 ( 3.0,8.0 ) vs 7.0 ( 3.0,13.8 ) , 4.0 ( 1.5,7.0 ) vs 6.0 ( 2.0,11.7 ) , both P < 0.05 ] .
-RESULTS	In 8 weeks of treatment and the follow-up observation , Barthel index was improved obviously as compared with that before treatment in the patients of the two groups ( all P < 0.05 ) .
-RESULTS	The improvement in the acupuncture group was much more significant as compared with the conventional treatment group [ 75.0 ( 60.0,87.5 ) vs 65 .
-RESULTS	O ( 36.3 , 87.5 ) , P < 0.051 .
-CONCLUSIONS	Based on the conventional treatment , Acupuncture achieves the satisfactory clinical efficacy on motor dysfunction in ischemic stroke of subacute stage .
-
-###25454414
-BACKGROUND	Fluorouracil and irinotecan-based , and gemcitabine-based regimens , are the standard of care in the first-line treatment of patients with metastatic pancreatic cancer .
-BACKGROUND	New approaches are needed to improve survival and quality of life .
-BACKGROUND	Whether a sequential approach alternating irinotecan , fluorouracil and gemcitabine may be effective and tolerable in patients with metastatic pancreatic cancer is unknown .
-METHODS	In this randomised , multicentre , open-label , phase 2 trial , patients with metastatic pancreatic adenocarcinoma , World Health Organisation ( WHO ) performance status 0-1 , and bilirubin levels < 1.5 upper limit of normal values ( ULN ) were randomised 1:1 to receive as first-line treatment either FOLFIRI .3 ( irinotecan , leucovorin and fluorouracil ) alternating with fixed-dose rate gemcitabine as 2-month periods ( FIRGEM , arm A ) , or fixed-dose rate gemcitabine alone ( arm B ) .
-METHODS	Treatment was continued until disease progression or limiting toxicity .
-METHODS	The primary end-point was the crude progression-free survival ( PFS ) rate at 6 months .
-METHODS	The study is registered with EudraCT ( N 2006-005703-34 ) .
-RESULTS	Between October 2007 and March 2011 , 98 patients were enroled .
-RESULTS	The observed 6-month PFS rate was 43.5 % ( 95 % confidence interval ( CI ) , [ 28.6-58 .4 % ] ) in arm A reaching the Fleming decision rules criteria to reject H0 and 26.1 % ( 95 % CI [ 12.9-39 .3 % ] ) in arm B. Objective response rates were 37 % ( 23-51 % ) in arm A and 10 % ( 1-19 % ) in arm B. Median PFS ( 5.0 versus 3.4 months , hazard ratio ( HR ) = 0.59 [ 0.38-0 .90 ] ) and overall survival ( 11.0 versus 8.2 months , HR = 0.71 [ 0.46-1 .10 ] ) were higher in arm A compared to arm B.
-RESULTS	The most frequent grade 3-4 toxicities were neutropenia ( 49 % / 24 % ; febrile neutropenia , 4 % / 0 % in arms A/B ) , diarrhoea ( arm A , 12 % and arm B , 0 % ) , and nausea/vomiting ( 8 % / 4 % ) .
-RESULTS	No toxic deaths occurred .
-CONCLUSIONS	The FIRGEM strategy appears to be effective and feasible in patients with metastatic pancreatic cancer .
-
-###25121977
-BACKGROUND	Antidepressant prescriptions have increased exponentially , burdening health care costs .
-OBJECTIVE	To evaluate the costs and effects of an antidepressant cessation advice in case of inappropriate long-term use in primary care , i.e. long-term usage without a ( current ) indication .
-METHODS	A economic evaluation during 1-year follow-up was performed , from a societal perspective , as part of a cluster-randomised controlled clinical trial ( PANDA ) .
-METHODS	Costs were assessed using the Trimbos/iMTA questionnaire for costs associated with psychiatric illness .
-METHODS	Health-related quality of life was measured using the EuroQol 5D .
-METHODS	Outcome was costs per quality adjusted life year ( QALY ) .
-METHODS	Missing values were estimated using multiple imputation , bootstrap simulations were performed to address the uncertainty surrounding the incremental cost-effectiveness ratios ( ICERs ) .
-RESULTS	There was no difference in average QALYs between the intervention ( 0.70 ) and control group ( 0.72 ) [ difference -0.02 ( 95 % CI -0.05 to 0.10 ) ] .
-RESULTS	The intervention group , however , was less expensive than the control group ( total costs 3636 versus 5267 , respectively ) .
-RESULTS	Most cost-effectiveness pairs were located in the south-west quadrant of the cost-effectiveness plane , implying the intervention was less effective but also less costly .
-RESULTS	The ICER of the pooled data was 70,180 , meaning that for one QALY lost , 70,180 is saved .
-CONCLUSIONS	This study shows that an antidepressant cessation advice given to patients ( and their FPs ) with inappropriate long-term antidepressant usage , albeit not effective , does seem to result in a reduction of societal costs .
-CONCLUSIONS	This reduction in costs is mostly due to reduction of productivity losses , possibly due to patient empowerment and loss of stigma .
-
-###25066329
-BACKGROUND	Evidence is weak for the ability of long-term non-invasive positive pressure ventilation ( NPPV ) to improve survival in patients with stable hypercapnic chronic obstructive pulmonary disease ( COPD ) .
-BACKGROUND	Previous prospective studies did not target a reduction in hypercapnia when adjusting ventilator settings .
-BACKGROUND	This study investigated the effect of long-term NPPV , targeted to markedly reduce hypercapnia , on survival in patients with advanced , stable hypercapnic COPD .
-METHODS	This investigator-initiated , prospective , multicentre , randomised , controlled clinical trial enrolled patients with stable GOLD stage IV COPD and a partial carbon dioxide pressure ( PaCO2 ) of 7 kPa ( 51.9 mm Hg ) or higher and pH higher than 7.35 .
-METHODS	NPPV was targeted to reduce baseline PaCO2 by at least 20 % or to achieve PaCO2 values lower than 6.5 kPa ( 48.1 mm Hg ) .
-METHODS	Patients were randomly assigned ( in a 1:1 ratio ) via a computer-generated randomisation sequence with a block size of four , to continue optimised standard treatment ( control group ) or to receive additional NPPV for at least 12 months ( intervention group ) .
-METHODS	The primary outcome was 1-year all-cause mortality .
-METHODS	Analysis was by intention to treat .
-METHODS	The intervention was unblinded , but outcome assessment was blinded to treatment assignment .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT00710541 .
-RESULTS	Patients were recruited from 36 respiratory units in Germany and Austria , starting on Oct 29 , 2004 , and terminated with a record of the vital status on July 31 , 2011.195 patients were randomly assigned to the NPPV group ( n = 102 ) or to the control group ( n = 93 ) .
-RESULTS	All patients from the control group and the NPPV group were included in the primary analysis .
-RESULTS	1-year mortality was 12 % ( 12 of 102 patients ) in the intervention group and 33 % ( 31 of 93 patients ) in the control group ; hazard ratio 0.24 ( 95 % CI 0.11-0 .49 ; p = 0.0004 ) .
-RESULTS	14 ( 14 % ) patients reported facial skin rash , which could be managed by changing the type of the mask .
-RESULTS	No other intervention-related adverse events were reported .
-CONCLUSIONS	The addition of long-term NPPV to standard treatment improves survival of patients with hypercapnic , stable COPD when NPPV is targeted to greatly reduce hypercapnia .
-BACKGROUND	German Lung Foundation ; ResMed , Germany ; Tyco Healthcare , Germany ; and Weinmann , Germany .
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-###24643203
-BACKGROUND	Previous phase III studies in patients with advanced Parkinson 's disease ( PD ) not adequately controlled on levodopa demonstrated significant reduction of ` off ' time with rotigotine transdermal system up to 16 mg/24 h. However , the minimal effective dose has not been established .
-OBJECTIVE	This international , randomized , double-blind , placebo-controlled study ( SP921 ; NCT00522379 ) investigated rotigotine dose response up to 8 mg/24 h.
-METHODS	Patients with advanced idiopathic PD ( 2.5 h of daily ` off ' time on stable doses of levodopa ) were randomized 1:1:1:1:1 to receive rotigotine 2 , 4 , 6 , or 8 mg/24 h or placebo , titrated over 4 weeks and maintained for 12 weeks .
-METHODS	The primary efficacy variable was change from baseline to end of maintenance in absolute time spent ` off ' .
-RESULTS	409/514 ( 80 % ) randomized patients completed maintenance .
-RESULTS	Mean ( SD ) baseline daily ` off ' times ( h/day ) were placebo : 6.4 ( 2.5 ) , rotigotine 2-8 mg/24 h : 6.4 ( 2.6 ) .
-RESULTS	Rotigotine 8 mg/24 h was the minimal dose to significantly reduce ` off ' time versus placebo .
-RESULTS	LS mean ( SE ) absolute change in daily ` off ' time ( h/day ) from baseline was -2.4 ( 0.28 ) with rotigotine 8 mg/24 h , and -1.5 ( 0.26 ) with placebo ; absolute change in ` off ' time in the 8 mg/24 h group compared with placebo was -0.85 h/day ( 95 % CI -1.59 , -0.11 ; p = 0.024 ) .
-RESULTS	There was an apparent dose-dependent trend .
-RESULTS	Adverse events ( AEs ) reported at a higher incidence in the rotigotine 8 mg/24 h group versus placebo included application site reactions , nausea , dry mouth , and dyskinesia ; there was no worsening of insomnia , somnolence , orthostatic hypotension , confusional state or hallucinations , even in patients 75 years of age .
-CONCLUSIONS	The minimal statistically significant effective dose of rotigotine to reduce absolute ` off ' time was 8 mg/24 h.
-CONCLUSIONS	The AE profile was similar to previous studies .
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-###24622715
-BACKGROUND	Metformin reduces cardiovascular risk in patients with type 2 diabetes seemingly independent of lowering blood glucose concentration .
-BACKGROUND	We assessed the cardiovascular effects of metformin in individuals without type 2 diabetes .
-METHODS	We did a single-centre , double-blind , placebo-controlled trial at the Glasgow Clinical Research Facility ( Glasgow , UK ) .
-METHODS	We enrolled patients taking statins who did not have type 2 diabetes but who did have coronary heart disease and large waist circumferences .
-METHODS	Participants were randomly assigned ( 1:1 ) by computer to either metformin ( 850 mg twice daily ) or matching placebo in block sizes of four .
-METHODS	Patients , investigators , trial staff , and statisticians were masked to treatment allocation .
-METHODS	The primary endpoint was progression of mean distal carotid intima-media thickness ( cIMT ) over 18 months in the modified intention-to-treat population .
-METHODS	Secondary endpoints were changes in carotid plaque score ( in six regions ) , measures of glycaemia ( HbA1c , fasting glucose , and insulin concentrations , and Homeostasis Model Assessment of Insulin Resistance [ HOMA-IR ] ) , and concentrations of lipids , high sensitivity C-reactive protein , and tissue plasminogen activator .
-METHODS	The trial was registered at ClinicalTrials.gov , number NCT00723307 .
-RESULTS	We screened 356 patients , of whom we enrolled 173 ( 86 in the metformin group , 87 in the placebo group ) .
-RESULTS	Average age was 63 years .
-RESULTS	At baseline , mean cIMT was 0717 mm ( SD 0129 ) and mean carotid plaque score was 243 ( SD 155 ) .
-RESULTS	cIMT progression did not differ significantly between groups ( slope difference 0007 mm per year , 95 % CI -0006 to 0020 ; p = 029 ) .
-RESULTS	Change of carotid plaque score did not differ significantly between groups ( 001 per year , 95 % CI -023 to 026 ; p = 092 ) .
-RESULTS	Patients taking metformin had lower HbA1c , insulin , HOMA-IR , and tissue plasminogen activator compared with those taking placebo , but there were no significant differences for total cholesterol , HDL-cholesterol , non-HDL-cholesterol , triglycerides , high sensitivity C-reactive protein , or fasting glucose .
-RESULTS	138 adverse events occurred in 64 patients in the metformin group versus 120 in 60 patients in the placebo group .
-RESULTS	Diarrhoea and nausea or vomiting were more common in the metformin group than in the placebo group ( 28 vs 5 ) .
-CONCLUSIONS	Metformin had no effect on cIMT and little or no effect on several surrogate markers of cardiovascular disease in non-diabetic patients with high cardiovascular risk , taking statins .
-CONCLUSIONS	Further evidence is needed before metformin can be recommended for cardiovascular benefit in this population .
-BACKGROUND	Chief Scientist Office ( Scotland ) .
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-###25662415
-BACKGROUND	Most patients with hip fractures are characterised by older age ( > 70 years ) , frailty , and functional deterioration , and their long-term outcomes are poor with increased costs .
-BACKGROUND	We compared the effectiveness and cost-effectiveness of giving these patients comprehensive geriatric care in a dedicated geriatric ward versus the usual orthopaedic care .
-METHODS	We did a prospective , single-centre , randomised , parallel-group , controlled trial .
-METHODS	Between April 18 , 2008 , and Dec 30 , 2010 , we randomly assigned home-dwelling patients with hip-fractures aged 70 years or older who were able to walk 10 m before their fracture , to either comprehensive geriatric care or orthopaedic care in the emergency department , to achieve the required sample of 400 patients .
-METHODS	Randomisation was achieved via a web-based , computer-generated , block method with unknown block sizes .
-METHODS	The primary outcome , analysed by intention to treat , was mobility measured with the Short Physical Performance Battery ( SPPB ) 4 months after surgery for the fracture .
-METHODS	The type of treatment was not concealed from the patients or staff delivering the care , and assessors were only partly masked to the treatment during follow-up .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT00667914 .
-RESULTS	We assessed 1077 patients for eligibility , and excluded 680 , mainly for not meeting the inclusion criteria such as living in a nursing home or being aged less than 70 years .
-RESULTS	Of the remaining patients , we randomly assigned 198 to comprehensive geriatric care and 199 to orthopaedic care .
-RESULTS	At 4 months , 174 patients remained in the comprehensive geriatric care group and 170 in the orthopaedic care group ; the main reason for dropout was death .
-RESULTS	Mean SPPB scores at 4 months were 512 ( SE 020 ) for comprehensive geriatric care and 438 ( SE 020 ) for orthopaedic care ( between-group difference 074 , 95 % CI 018-130 , p = 0010 ) .
-CONCLUSIONS	Immediate admission of patients aged 70 years or more with a hip fracture to comprehensive geriatric care in a dedicated ward improved mobility at 4 months , compared with the usual orthopaedic care .
-CONCLUSIONS	The results suggest that the treatment of older patients with hip fractures should be organised as orthogeriatric care .
-BACKGROUND	Norwegian Research Council , Central Norway Regional Health Authority , St Olav Hospital Trust and Fund for Research and Innovation , Liaison Committee between Central Norway Regional Health Authority and the Norwegian University of Science and Technology , the Department of Neuroscience at the Norwegian University of Science and Technology , Foundation for Scientific and Industrial Research at the Norwegian Institute of Technology ( SINTEF ) , and the Municipality of Trondheim .
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-###24586327
-BACKGROUND	Community level interventions to improve maternal and child health have been supported and well evaluated in resource poor settings , but less so in developed countries .
-BACKGROUND	PRISM -- Program of Resources , Information and Support for Mothers -- was a primary care and community-based cluster-randomised trial in sixteen municipalities in Victoria , Australia , which aimed to reduce depression in mothers and improve their physical health .
-BACKGROUND	The aim of this paper is to report the longer term outcomes of PRISM and to reflect on lessons learned from this universal community intervention to improve maternal health .
-METHODS	Maternal health outcome data in PRISM were collected by postal questionnaire at six months and two years .
-METHODS	At two years , the main outcome measures included the Edinburgh Postnatal Depression Scale ( EPDS ) and the SF-36 .
-METHODS	Secondary outcome measures included the Experience of Motherhood Scale ( EOM ) and the Parenting Stress Index ( PSI ) .
-METHODS	A primary intention to treat analysis was conducted , adjusting for the randomisation by cluster .
-RESULTS	7,169 / 18,424 ( 39 % ) women responded to the postal questionnaire at two years -3,894 ( 40 % ) in the intervention arm and 3,275 ( 38 % ) in the comparison arm .
-RESULTS	Respondents were mostly representative on available population data comparisons .
-RESULTS	There were no differences in depression prevalence ( EPDS13 ) between the intervention and comparison arms ( 13.4 % vs 13.1 % ; ORadj = 1.06 , 95 % CI 0.91-1 .24 ) .
-RESULTS	Nor did women 's mental health ( MCS : 48.6 vs 49.1 ) or physical health scores ( PCS : 49.1 vs 49.0 ) on the SF-36 differ between the trial arms .
-CONCLUSIONS	Improvement in maternal mental and physical health outcomes at the population level in the early years after childbirth remains a largely unmet challenge .
-CONCLUSIONS	Despite the lack of effectiveness of PRISM intervention strategies , important lessons about systems change , sustained investment and contextual understanding of the workability of intervention strategies can be drawn from the experience of PRISM .
-CONCLUSIONS	Trial Registration .
-CONCLUSIONS	Controlled-Trials .
-CONCLUSIONS	com ISRCTN03464021 .
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-###24479722
-OBJECTIVE	To compare the safety and efficacy of a single subconjunctival injection of methylprednisolone and a standard postoperative steroid regimen in terms of intraocular inflammation and intraocular pressure ( IOP ) after uncomplicated phacoemulsification surgery .
-METHODS	Two groups of 25 patients each were included in this prospective randomized controlled trial .
-METHODS	Patients in the injection group were given a subconjunctival injection of 20 mg methylprednisolone and the topical group received the conventional postoperative care with steroid eye drops ( dexamethasone 1 mg/ml ) .
-METHODS	The patients were examined 1 week and 1 month after surgery .
-METHODS	Slit-lamp evaluation of anterior chamber inflammation and IOP were performed .
-METHODS	Changes in IOP of 2.4 mmHg were considered clinically relevant .
-RESULTS	In the injection group , mean IOP decreased from 15.4 2.2 mmHg ( baseline ) to 14.1 3.2 mmHg at 1 week ( p = 0.03 ) .
-RESULTS	The topical group had a stable IOP at 1 week ( 16.3 2.6 mmHg ) compared to baseline ( 16.1 2.7 mmHg ; p = 0.74 ) .
-RESULTS	At 1 month , mean IOP was 14.3 2.6 mmHg ( p = 0.03 ) in the injection group and 15.6 2.3 mmHg ( p = 0.2 ) in the topical group .
-RESULTS	The intragroup changes were neither statistically significant nor clinically relevant at any postoperative visit .
-RESULTS	Both groups had the highest values of intraocular inflammation at the 1-week postoperative visit , followed by a decline to barely traceable levels at 1 month .
-RESULTS	The difference was not clinically relevant at any postoperative visit .
-CONCLUSIONS	The subconjunctival injection of methylprednisolone appears to be as safe and effective as the conventional treatment , and it might therefore be considered for treatment of individuals with compliance issues .
-
-###24933136
-OBJECTIVE	To examine the feasibility , acceptability , and potential effectiveness of an online intervention targeting college smokers .
-OBJECTIVE	The incentives involved discounted or free goods and services from businesses proximal to each campus .
-METHODS	A randomized controlled trial was conducted with 122 current smokers recruited from 2 Southeastern US universities .
-METHODS	The intervention involved health behavior monitoring , targeted messaging , and incentives for healthy goods and services versus the American Cancer Society 's Guide to Quitting Smoking online .
-RESULTS	The intervention achieved greater adherence and utilization ( p 's < .001 ) .
-RESULTS	Overall , 55.6 % learned about a local business through this program .
-RESULTS	At end-of-treatment , intervention participants less frequently attempted to quit ( p = .02 ) but smoked fewer cigarettes/day ( p = .05 ) .
-RESULTS	Both groups demonstrated significant end-of-treatment cessation rates .
-CONCLUSIONS	This intervention demonstrated feasibility and acceptability .
-
-###25056602
-BACKGROUND	The optimal model of total dose and fraction size for patients with locally recurrent nasopharyngeal carcinoma treated with intensity-modulated radiotherapy ( IMRT ) remains unclear .
-BACKGROUND	The authors designed a randomized phase 2 clinical trial to investigate the efficacy of 2 different models , with the objective of determining an optimal model .
-METHODS	Between January 2003 and December 2007 , a total of 117 patients with locally recurrent nonmetastatic nasopharyngeal carcinoma were randomized to 2 different models of total dose and fraction size : group A ( 59 patients ) received 60 gray in 27 fractions and group B ( 58 patients ) received 68 gray in 34 fractions .
-METHODS	Both groups received 5 daily fractions per week .
-METHODS	All patients received IMRT alone .
-RESULTS	The median follow-up was 25.0 months .
-RESULTS	The 5-year overall survival in group A was higher than that in group B ( 44.2 % vs 30.3 % ; P = .06 ) , and the local failure-free survival in group A was slightly lower than that in group B ( 63.7 % vs 71.0 % ; P = .41 ) .
-RESULTS	Severe late complications were the main cause of death .
-RESULTS	The incidences of mucosal necrosis and massive hemorrhage in patients in group B were significantly higher than those among patients in group A at 50.8 % versus 28.8 % ( P = .02 ) and 31.0 % versus 18.6 % ( P = .12 ) , respectively .
-RESULTS	Tumor volume ( P < .01 ) and model of total dose and fraction size ( P = .03 ) were found to be significant factors for mucosal necrosis and massive hemorrhage .
-CONCLUSIONS	Appropriately decreasing the total dose and increasing the fraction size can achieve local control similar to that achieved with a higher dose after IMRT ; furthermore , it can improve overall survival by significantly reducing the incidence of severe late complications including mucosal necrosis and massive hemorrhage .
-
-###25197733
-OBJECTIVE	To examine the effect of chocobar ice cream containing bifidobacteria on salivary mutans streptococci and lactobacilli .
-METHODS	A double-blind , randomised controlled trial was conducted with 30 subjects ( 18 to 22 years of age ) divided into 2 groups , test ( chocobar ice cream with probiotics ) and control ( chocobar ice cream without probiotics ) .
-METHODS	The subjects were instructed to eat the allotted chocobar ice cream once daily for 18 days .
-METHODS	Saliva samples collected at intervals were cultured on Mitis Salivarius agar and Rogosa agar and examined for salivary mutans streptococci and lactobacilli , respectively .
-METHODS	The Mann-Whitney U-test , Friedman and Wilcoxon signed-rank tests were used for statistical analysis .
-RESULTS	Postingestion in the test group , a statistically significant reduction ( p < 0.05 ) of salivary mutans streptococci was recorded , but a non-significant trend was seen for lactobacilli .
-RESULTS	Significant differences were was also observed between follow-ups .
-CONCLUSIONS	Short-term daily ingestion of ice cream containing probiotic bifidobacteria may reduce salivary levels of mutans streptococci in young adults .
-
-###26398071
-BACKGROUND	The standard therapy for women with unexplained infertility is gonadotropin or clomiphene citrate .
-BACKGROUND	Ovarian stimulation with letrozole has been proposed to reduce multiple gestations while maintaining live birth rates .
-METHODS	We enrolled couples with unexplained infertility in a multicenter , randomized trial .
-METHODS	Ovulatory women 18 to 40 years of age with at least one patent fallopian tube were randomly assigned to ovarian stimulation ( up to four cycles ) with gonadotropin ( 301 women ) , clomiphene ( 300 ) , or letrozole ( 299 ) .
-METHODS	The primary outcome was the rate of multiple gestations among women with clinical pregnancies .
-RESULTS	After treatment with gonadotropin , clomiphene , or letrozole , clinical pregnancies occurred in 35.5 % , 28.3 % , and 22.4 % of cycles , and live birth in 32.2 % , 23.3 % , and 18.7 % , respectively ; pregnancy rates with letrozole were significantly lower than the rates with standard therapy ( gonadotropin or clomiphene ) ( P = 0.003 ) or gonadotropin alone ( P < 0.001 ) but not with clomiphene alone ( P = 0.10 ) .
-RESULTS	Among ongoing pregnancies with fetal heart activity , the multiple gestation rate with letrozole ( 9 of 67 pregnancies , 13 % ) did not differ significantly from the rate with gonadotropin or clomiphene ( 42 of 192 , 22 % ; P = 0.15 ) or clomiphene alone ( 8 of 85 , 9 % ; P = 0.44 ) but was lower than the rate with gonadotropin alone ( 34 of 107 , 32 % ; P = 0.006 ) .
-RESULTS	All multiple gestations in the clomiphene and letrozole groups were twins , whereas gonadotropin treatment resulted in 24 twin and 10 triplet gestations .
-RESULTS	There were no significant differences among groups in the frequencies of congenital anomalies or major fetal and neonatal complications .
-CONCLUSIONS	In women with unexplained infertility , ovarian stimulation with letrozole resulted in a significantly lower frequency of multiple gestation but also a lower frequency of live birth , as compared with gonadotropin but not as compared with clomiphene .
-CONCLUSIONS	( Funded by the National Institutes of Health and others ; ClinicalTrials.gov number , NCT01044862 . )
-
-###25018069
-OBJECTIVE	To assess the optimal pancreatic phase delay in terms of parenchymal enhancement and tumor-to-pancreas contrast with a bolus-tracking method .
-METHODS	Patients referred for suspicion of pancreatic tumor and undergoing 64-detector computed tomography scanner were randomized to an individualized scan delay of 10 , 20 , or 30seconds of nonionic contrast material ( 370mg I/mL ) after aortic enhancement above 150 Hounsfield units .
-METHODS	The volume of contrast was adjusted to patient weight .
-METHODS	Pancreatic and tumor enhancements were measured .
-METHODS	Statistical analysis included analysis of variance and post hoc Tukey tests .
-RESULTS	One hundred and fifty patients were randomized to individualized scan delays of 10 , 20 , or 30seconds .
-RESULTS	Pancreatic parenchymal enhancement in all patients ( n = 150 ) was significantly higher with a delay of 20 or 30 seconds than that with 10 seconds ( P < .001 for both ) .
-RESULTS	Tumor-to-pancreas contrast for solid tumors ( n = 59 ) was significantly higher with a delay of 30seconds than that with 10seconds ( P = .015 ) .
-RESULTS	Adenocarcinoma-to-pancreas contrast during pancreatic phase was significantly higher for a 20 - or 30-second delay than for a 10-second delay ( P = .027 and .011 , respectively ) for one reader .
-CONCLUSIONS	With a flow rate of 4mL/s and weight-adjusted contrast volume , an individualized scan delay of 30seconds after aortic transit time revealed higher pancreatic enhancement and tumor-to-pancreas contrast than that with a delay of 10seconds .
-
-###25282565
-BACKGROUND	Epidemiologic and preclinical data , and a small randomized trial in Boston , suggest that vitamin D supplementation may improve winter-related atopic dermatitis ( AD ) .
-OBJECTIVE	To determine the effect of vitamin D supplementation on winter-related AD .
-METHODS	We performed a randomized , double-blind , placebo-controlled trial of Mongolian children with winter-related AD ( clinicaltrials.gov identifier : NCT00879424 ) .
-METHODS	Baseline eligibility included age 2 to 17 years , AD score 10 to 72 using the Eczema Area and Severity Index ( EASI ) , and winter-related AD ( eg , history of AD worsening during the fall-to-winter transition ) .
-METHODS	Subjects were enrolled in Ulaanbaatar during winter and randomly assigned to oral cholecalciferol ( 1000 IU/day ) versus placebo for 1 month .
-METHODS	All children and parents received emollient and patient education about AD and basic skin care .
-METHODS	The main outcomes were changes in EASI score and in Investigator 's Global Assessment .
-RESULTS	The 107 enrolled children had a mean age of 9 years ( SD 5 ) , and 59 % were male .
-RESULTS	Their median age of AD onset was 3 months ( interquartile range 2 months to 1 year ) and mean EASI score at baseline 21 ( SD 9 ) .
-RESULTS	One-month follow-up data were available for 104 ( 97 % ) children .
-RESULTS	Compared with placebo , vitamin D supplementation for 1 month produced a clinically and statistically significant improvement in EASI score ( adjusted mean change : -6.5 vs -3.3 , respectively ; P = .04 ) .
-RESULTS	Moreover , change in Investigator 's Global Assessment favored vitamin D over placebo ( P = .03 ) .
-RESULTS	There were no adverse effects in either group .
-CONCLUSIONS	Vitamin D supplementation improved winter-related AD among Mongolian children , a population likely to have vitamin D deficiency in winter .
-
-###24753478
-METHODS	Since bolus administration of capsaicin has been shown to reduce appetite and ad libitum energy intake , this study elucidated the satiating effect of the less pungent capsaicin analog , nonivamide , on subjective feelings of hunger , ad libitum food intake , and satiating hormones in moderately overweight male subjects .
-RESULTS	Following a randomized , crossover design , 24 male subjects ( BMI 27.5 1.53 kg/m ( 2 ) ) received either 75 g glucose in 300 mL water ( control treatment , CT ) or the same glucose solution supplemented with 0.15 mg nonivamide ( nonivamide treatment , NT ) .
-RESULTS	Ratings of hunger were assessed before and 2 h after each intervention by means of visual analog scales .
-RESULTS	Ad libitum energy and macronutrient intakes from a standardized breakfast 2 h postintervention were calculated .
-RESULTS	Plasma glucose , insulin , peptide YY ( 3-36 ) , glucagon-like peptide 1 , and serotonin were quantified in blood samples drawn before and 15 , 30 , 60 , 90 , and 120 min after each intervention .
-RESULTS	NT reduced subjective feelings of hunger and ad libitum energy and carbohydrate intakes from a standardized breakfast compared to CT. .
-RESULTS	Plasma analysis revealed higher mean plasma glucagon-like peptide 1 and serotonin concentrations after NT versus CT. .
-CONCLUSIONS	Addition of 0.15 mg nonivamide to a glucose solution reduced ad libitum energy intake from a standardized breakfast in moderately overweight men .
-
-###25271544
-OBJECTIVE	Selective decontamination of the digestive tract ( SDD ) and selective oropharyngeal decontamination ( SOD ) are prophylactic antibiotic regimens used in intensive care units ( ICUs ) and associated with improved patient outcome .
-OBJECTIVE	Controversy exists regarding the relative effects of both measures on patient outcome and antibiotic resistance .
-OBJECTIVE	To compare the effects of SDD and SOD , applied as unit-wide interventions , on antibiotic resistance and patient outcome .
-METHODS	Pragmatic , cluster randomized crossover trial comparing 12 months of SOD with 12 months of SDD in 16 Dutch ICUs between August 1 , 2009 , and February 1 , 2013 .
-METHODS	Patients with an expected length of ICU stay longer than 48 hours were eligible to receive the regimens , and 5881 and 6116 patients were included in the clinical outcome analysis for SOD and SDD , respectively .
-METHODS	Intensive care units were randomized to administer either SDD or SOD .
-METHODS	Unit-wide prevalence of antibiotic-resistant gram-negative bacteria .
-METHODS	Secondary outcomes were day-28 mortality , ICU-acquired bacteremia , and length of ICU stay .
-RESULTS	In point-prevalence surveys , prevalences of antibiotic-resistant gram-negative bacteria in perianal swabs were significantly lower during SDD compared with SOD ; for aminoglycoside resistance , average prevalence was 5.6 % ( 95 % CI , 4.6 % -6.7 % ) during SDD and 11.8 % ( 95 % CI , 10.3 % -13.2 % ) during SOD ( P < .001 ) .
-RESULTS	During both interventions the prevalence of rectal carriage of aminoglycoside-resistant gram-negative bacteria increased 7 % per month ( 95 % CI , 1 % -13 % ) during SDD ( P = .02 ) and 4 % per month ( 95 % CI , 0 % -8 % ) during SOD ( P = .046 ; P = .40 for difference ) .
-RESULTS	Day 28-mortality was 25.4 % and 24.1 % during SOD and SDD , respectively ( adjusted odds ratio , 0.96 [ 95 % CI , 0.88-1 .06 ] ; P = .42 ) , and there were no statistically significant differences in other outcome parameters or between surgical and nonsurgical patients .
-RESULTS	Intensive care unit-acquired bacteremia occurred in 5.9 % and 4.6 % of the patients during SOD and SDD , respectively ( odds ratio , 0.77 [ 95 % CI , 0.65-0 .91 ] ; P = .002 ; number needed to treat , 77 ) .
-CONCLUSIONS	Unit-wide application of SDD and SOD was associated with low levels of antibiotic resistance and no differences in day-28 mortality .
-CONCLUSIONS	Compared with SOD , SDD was associated with lower rectal carriage of antibiotic-resistant gram-negative bacteria and ICU-acquired bacteremia but a more pronounced gradual increase in aminoglycoside-resistant gram-negative bacteria .
-BACKGROUND	trialregister.nlIdentifier : NTR1780 .
-
-###24888209
-OBJECTIVE	This study explored possible mechanisms through which symptoms of posttraumatic stress disorder ( PTSD ) were reduced in a randomized controlled trial comparing the effect of a yoga intervention with an assessment control .
-METHODS	We examined whether changes in psychological flexibility , mindfulness , and emotion regulation strategies ( expressive suppression and reappraisal ) were associated with posttreatment PTSD symptoms for 38 women with Diagnostic and Statistical Manual of Mental Disorders Fourth Edition full or subthreshold PTSD .
-RESULTS	Hierarchical linear regression models revealed that expressive suppression significantly decreased for the yoga group relative to the assessment control .
-RESULTS	Psychological flexibility increased significantly for the control but not yoga group .
-RESULTS	However , increases in psychological flexibility were associated with decreases in PTSD symptoms for the yoga but not control group .
-CONCLUSIONS	Preliminary findings suggest that yoga may reduce expressive suppression and may improve PTSD symptoms by increasing psychological flexibility .
-CONCLUSIONS	More research is needed to replicate and extend these findings .
-
-###24748630
-OBJECTIVE	Assess golimumab 's long-term efficacy/safety in psoriatic arthritis ( PsA ) .
-METHODS	Adults with active PsA ( 3 swollen and tender joints , active psoriasis ) were randomly assigned to subcutaneous placebo , golimumab 50mg , or golimumab 100mg every 4weeks ( q4wks ) through wk20 .
-METHODS	All patients received golimumab 50mg or 100mg q4wks from wk24 forward .
-METHODS	Methotrexate was allowed and taken by approximately half the patients .
-METHODS	Findings through 5years are reported herein .
-METHODS	Efficacy assessments included 20 % improvement in American College of Rheumatology ( ACR20 ) response , C-reactive-protein-based , 28-joint-count Disease Activity Score ( DAS28-CRP ) response , 75 % improvement in Psoriasis Area and Severity Index ( PASI75 ) scores , and PsA-modified Sharp/van der Heijde scores ( SHSs ) .
-RESULTS	126/405 ( 31 % ) randomised patients discontinued treatment through wk252 .
-RESULTS	Golimumab was effective in maintaining clinical improvement through year-5 ( ACR20 : 62.8-69 .9 % , DAS28-CRP : 75.2-84 .9 % for randomised patients ; PASI75 : 60.8-72 .2 % among randomised patients with 3 % body surface area involvement ) and inhibiting radiographic progression ( mean changes in PsA-modified SHS : 0.1-0 .3 ) among patients with radiographic data .
-RESULTS	While concomitant methotrexate did not affect ACR20/PASI75 , it appeared to reduce radiographic progression .
-RESULTS	No new safety signals were identified .
-RESULTS	Antibodies-to-golimumab occurred in 1.8 % / 10.0 % of patients with/without methotrexate ) .
-CONCLUSIONS	Long-term golimumab safety/efficacy in PsA was demonstrated through 5years .
-BACKGROUND	NCT00265096 .
-
-###26006702
-OBJECTIVE	Onapristone is an antiprogestin with activity in breast cancer and is under investigation for use in endometrial , ovarian and prostate cancers .
-OBJECTIVE	Megestrol acetate and abiraterone generally show variability in absorption and , depending on the formulation , food effect .
-OBJECTIVE	This study was conducted to determine the effect of food on 10mg oral immediate-release ( IR ) onapristone and to help identify a formulation to minimize variability .
-METHODS	This is an open-label , randomized , crossover study to determine the pharmacokinetic profile of onapristone and its main metabolite , N-mono-desmethyl onapristone .
-METHODS	Twelve healthy female subjects received 10mg of oral IR onapristone after an overnight fast , or within 30min of a high-fat , high-calorie meal with a 2-week washout between dosing periods .
-RESULTS	Onapristone plasma t1/2 ( meanSD ) was 4.360.81 h for the fasted state and 3.760.36 h for the fed state .
-RESULTS	Following food , onapristone tmax was delayed from 1 to 4h .
-RESULTS	Food intake was also associated with a small increase in AUC0 - of approximately 13 % and a statistically significant decrease in Cmax of approximately 18 % .
-RESULTS	One subject experienced a 23-day delay in menses after one 10mg onapristone dose , while another subject experienced transient grade 2 NCI-CTCAE liver enzyme elevation 3weeks post dose .
-CONCLUSIONS	The results are consistent with previous observations , indicating that there is a small increase in onapristone exposure and a significant decrease in Cmax when taken with food .
-CONCLUSIONS	These changes are within acceptable limits set out by the FDA .
-CONCLUSIONS	Thus , our findings indicate that onapristone could be administered without regard to food .
-
-###25700292
-OBJECTIVE	To review factors influencing placebo response and clinical trial outcome in depression , and suggest ways to optimize trial success in mood disorders .
-METHODS	PubMed searches were conducted by cross-referencing the terms depression , depressive with placebo , clinical trial , and clinical trials for studies published in English between 1970 and September 2013 .
-METHODS	Relevant abstracts were identified in PubMed , including clinical trials , quantitative studies , and qualitative research .
-METHODS	We obtained and reviewed relevant articles and utilized their information to synthesize the present review .
-METHODS	Included articles were grouped in the following areas of relevance : ( 1 ) biological validity of illness , ( 2 ) baseline severity of illness , ( 3 ) chronicity of the index episode of depression , ( 4 ) age of participants , ( 5 ) medical and psychiatric comorbidity , ( 6 ) probability of receiving placebo , ( 7 ) use of prospective treatment phases ( lead-in ) ( 8 ) dosing schedule , ( 9 ) trial duration , ( 10 ) frequency of follow-up assessments , and ( 11 ) study outcome measure .
-RESULTS	Several key elements emerge as critical to the ultimate success of a clinical trial , including the probability of receiving placebo , study duration , dosing schedule , visit frequency , the use of blinded lead-in phases , the use of centralized raters , illness severity and duration , and comorbid anxiety .
-CONCLUSIONS	Our increasing understanding of the placebo response in clinical trials of major depressive disorder lends to a , gradually , more predictable phenomenon and , hopefully , to one that becomes lesser in magnitude and variability .
-CONCLUSIONS	Several elements have emerged that seem to play a critical role in trial success , gradually reshaping the design of clinical , translational , as well as mechanistic studies in depression .
-
-###25216556
-BACKGROUND	Repetitive transcranial magnetic stimulation ( rTMS ) is a noninvasive tool for modulating cortical activity .
-OBJECTIVE	In this pilot study , we evaluated the effects of high frequency rTMS applied over the right inferior frontal gyrus ( IFG ) on cognitive functions in patients with amnestic mild cognitive impairment ( MCI ) or incipient dementia due to Alzheimer 's disease ( AD ) .
-METHODS	Ten patients ( 6 men ; 4 women , mean age of 72 8 years ; MMSE 23 3.56 ) were enrolled in a randomized , placebo-controlled study with a crossover design .
-METHODS	All participants received 2 sessions of 10 Hz rTMS over the non-dominant right hemisphere in random order : IFG ( active stimulation site ) and vertex ( control stimulation site ) .
-METHODS	Intensities were adjusted to 90 % of resting motor threshold .
-METHODS	A total of 2250 pulses were applied in a session .
-METHODS	The Trail Making Test ( TMT ) , the Stroop test , and the complex visual scene encoding task ( CVSET ) were administered before and immediately after each session .
-METHODS	The Wilcoxon paired test was used for data analysis .
-RESULTS	Stimulation applied over the IFG induced improvement in the TMT parts A ( p = 0.037 ) and B ( p = 0.049 ) .
-RESULTS	No significant changes were found in the Stroop test or the CVSET after the IFG stimulation .
-RESULTS	We observed no significant cognitive aftereffects of rTMS applied over the vertex .
-CONCLUSIONS	High frequency rTMS of the right IFG induced significant improvement of attention and psychomotor speed in patients with MCI/mild dementia due to AD .
-CONCLUSIONS	This pilot study is part of a more complex protocol and ongoing research .
-
-###25588782
-OBJECTIVE	To estimate the efficacy of a probiotic yogurt compared to a pasteurised yogurt for the prevention of antibiotic-associated diarrhoea in children .
-METHODS	This was a multisite , randomised , double-blind , placebo-controlled clinical trial conducted between September 2009 and 2012 .
-METHODS	The study was conducted through general practices and pharmacies in Launceston , Tasmania , Australia .
-METHODS	Children ( aged 1-12years ) prescribed antibiotics , were randomised to receive 200g/day of either yogurt ( probiotic ) containing Lactobacillus rhamnosus GG ( LGG ) , Bifidobacterium lactis ( Bb-12 ) and Lactobacillus acidophilus ( La-5 ) or a pasteurised yogurt ( placebo ) for the same duration as their antibiotic treatment .
-RESULTS	Stool frequency and consistency were recorded for the duration of treatment plus 1week .
-RESULTS	Primary outcome was stool frequency and consistency , classified at different levels of diarrhoea severity .
-RESULTS	Due to the small number of cases of diarrhoea , comparisons between groups were made using Fisher 's exact analysis .
-RESULTS	72 children commenced and 70 children ( 36 placebo and 34 probiotic ) completed the trial .
-RESULTS	There were no incidents of severe diarrhoea ( stool consistency 6 , 3 stools/day for 2 consecutive days ) in the probiotic group and six in the placebo group ( Fisher 's exact p = 0.025 ) .
-RESULTS	There was also only one episode of minor diarrhoea ( stool consistency 5 , 2 stools/day for 2days in the probiotic group compared to 21 in the placebo group ( Fisher 's exact p < 0.001 ) .
-RESULTS	The probiotic group reported fewer adverse events ( 1 had abdominal pain , 1 vomited and 1 had headache ) than the placebo group ( 6 had abdominal pain , 4 had loss of appetite and 1 had nausea ) .
-CONCLUSIONS	A yogurt combination of LGG , La-5 and Bb-12 is an effective method for reducing the incidence of antibiotic-associated diarrhoea in children .
-BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12609000281291 .
-
-###25835622
-OBJECTIVE	The clinical benefits and risks of dose escalation ( DE ) for stage III non-small-cell lung cancer ( NSCLC ) remain uncertain despite the results from Radiation Therapy Oncology Group ( RTOG ) protocol 0617 .
-OBJECTIVE	There is significant heterogeneity of practice , with many clinicians prescribing intermediate dose levels between the 0617 study arms of 60 and 74 Gy .
-OBJECTIVE	This study investigated whether this strategy is associated with any survival benefits/risks by analyzing a large multi-institutional database .
-METHODS	An individual patient database of stage III NSCLC patients treated with radical intent concurrent chemoradiation therapy was created ( 13 institutions , n = 1274 patients ) .
-METHODS	Patients were divided into 2 groups based on tumor Biological Effective Dose at 10 Gy ( BED 10 ) : those receiving standard dose ( SD ; n = 552 ) , consisting of 72Gy BED 10 76.8 Gy ( eg 60-64 Gy/30 -32 fractions [ fr ] ) , and those receiving intermediate dose ( ID ; n = 497 ) , consisting of 76.8 Gy < BED 10 < 100.8 Gy ( eg > 64 Gy/32 fr and < 74 Gy/37 fr ) , with lower-dose patients ( n = 225 ) excluded from consideration .
-METHODS	Patients were then matched using propensity scores , leading to 2 matched groups of 196 patients .
-METHODS	Outcomes were compared using various statistics including interquartile range ( IQR ) , Kaplan-Meier curves , and adjusted Cox regression analysis .
-RESULTS	Matched groups were found to be balanced except for N stage ( more N3 disease in SD ) , median treatment year ( SD in 2003 ; ID in 2007 ) , platinum and taxane chemotherapy ( SD in 28 % ; ID in 39 % ) , and median follow-up ( SD were 89 months ; ID were 40 months ) .
-RESULTS	Median dose fractionation was 60 Gy/30 fr in SD ( BED 10 IQR : 72.0-75 .5 Gy ) and 66 Gy/33 fr ( BED 10 IQR : 78.6-79 .2 Gy ) in ID .
-RESULTS	Survival curves for SD and ID matched cohorts were statistically similar ( P = .27 ) ; however , a nonstatistically significant trend toward better survival for ID was observed after 15 months ( median survival SD : 19.3 months ; ID : 21.0 months ) .
-RESULTS	There was an increase in grades III to V lung toxicity associated with ID ( 13.0 % vs 4.9 % , respectively ) .
-CONCLUSIONS	No significant overall survival benefits were found with intermediate DE ; however , more grade III or greater lung toxicity was observed .
-CONCLUSIONS	The separation of survival curves after 15 months of follow-up suggests that a small overall survival improvement associated with intermediate DE can not be excluded .
-
-###25093868
-BACKGROUND	Hochuekkito , a traditional herbal medicine , is occasionally prescribed in Japan to treat patients with a poor general condition .
-BACKGROUND	We aimed to examine whether this medicine was beneficial and tolerable for patients with progressed pulmonary Mycobacterium avium complex ( MAC ) disease .
-METHODS	This pilot open-label quasi-randomized controlled trial enrolled 18 patients with progressed pulmonary MAC disease who had initiated antimycobacterial treatment over one year ago but were persistently culture-positive or intolerant .
-METHODS	All patients continued their baseline treatment regimens with ( n = 9 ) or without ( n = 9 ) oral Hochuekkito for 24 weeks .
-RESULTS	Baseline characteristics were generally similar between the groups .
-RESULTS	Most patients were elderly ( median age 70 years ) , female , had a low body mass index ( < 20 kg/m2 ) , and a long-term disease duration ( median approximately 8 years ) .
-RESULTS	After the 24-week treatment period , no patient achieved sputum conversion .
-RESULTS	Although the number of colonies in sputum tended to increase in the control group , it generally remained stable in the Hochuekkito group .
-RESULTS	Radiological disease control was frequently observed in the Hochuekkito group than the control group ( 8/9 vs. 3/9 ; p = 0.05 ) .
-RESULTS	Patients in the Hochuekkito group tended to experience increase in body weight and serum albumin level compared with those in the control group ( median body weight change : +0.4 kg vs. -0.8 kg ; median albumin change : +0.2 g/dl vs. 0.0 g/dl ) .
-RESULTS	No severe adverse events occurred .
-CONCLUSIONS	Hochuekkito could be an effective , feasible adjunct to conventional therapy for patients with progressed pulmonary MAC disease .
-CONCLUSIONS	Future study is needed to explore this possibility .
-BACKGROUND	UMIN Clinical Trials Registry UMIN000009920 .
-
-###24647511
-BACKGROUND	While animal studies have shown better healing with a longer duration of protection without motion exercise after rotator cuff repair , supporting clinical studies are rare .
-BACKGROUND	The purpose of this study was to assess the effect of immobilization following rotator cuff repair and to determine whether there was any difference in clinical outcome related to the duration of immobilization .
-METHODS	One hundred patients who underwent arthroscopic single-row repair of a posterosuperior rotator cuff tear ( mean , 2.3 cm in the coronal-oblique plane and 2.0 cm in the sagittal-oblique plane ) were prospectively randomized to be treated with immobilization for four or eight weeks .
-METHODS	During the immobilization period , no passive or active range-of-motion exercise , including pendulum exercise , was allowed .
-METHODS	According to the intention-to-treat protocol and full analysis set , eighty-eight patients were evaluated clinically and with magnetic resonance imaging postoperatively , after exclusion of twelve patients without postoperative clinical evaluation .
-METHODS	Ranges of motion , clinical scores , and retear rates were compared between the four and eight-week groups .
-METHODS	Ninety-eight patients were contacted by telephone at a mean of thirty-five months to investigate the clinical outcomes .
-RESULTS	The mean duration of immobilization was 4.1 weeks in the four-week group and 7.3 weeks in the eight-week group .
-RESULTS	There were nine full-thickness retears ( 10 % ) , and 89 % of the patients rated their result as excellent or good .
-RESULTS	There were five full-thickness retears in the four-week group and four in the eight-week group ( p = 0.726 ) .
-RESULTS	At the time of final follow-up , the two groups showed no differences in range of motion or clinical scores .
-RESULTS	However , the proportion showing stiffness was higher in the eight-week group ( 38 % compared with 18 % , p = 0.038 ) .
-CONCLUSIONS	Eight weeks of immobilization did not yield a higher rate of healing of medium-sized rotator cuff tears compared with four weeks of immobilization .
-
-###24921919
-BACKGROUND	The optimal treatment for localised oesophageal squamous cell carcinoma ( SCC ) is uncertain .
-BACKGROUND	We assessed the feasibility of an RCT comparing neoadjuvant treatment and surgery with definitive chemoradiotherapy .
-METHODS	A feasibility RCT in three centres examined incident patients and reasons for ineligibility using multi-disciplinary team meeting records .
-METHODS	Eligible patients were offered participation in the RCT with integrated qualitative research involving audio-recorded recruitment appointments and interviews with patients to inform recruitment training for staff .
-RESULTS	Of 375 patients with oesophageal SCC , 42 ( 11.2 % ) were eligible .
-RESULTS	Reasons for eligibility varied between centres , with significantly differing proportions of patients excluded because of total tumour length ( P = 0.002 ) .
-RESULTS	Analyses of audio-recordings and patient interviews showed that recruiters had challenges articulating the trial design in simple terms , balancing treatment arms and explaining the need for randomisation .
-RESULTS	Before analyses of the qualitative data and recruiter training no patients were randomised .
-RESULTS	Following training in one centre 5 of 16 eligible patients were randomised .
-CONCLUSIONS	An RCT of surgical vs non-surgical treatment for SCC of the oesophagus is not feasible in the UK alone because of the low number of incident eligible patients .
-CONCLUSIONS	A trial comparing diverse treatment approaches may be possible with investment to support the recruitment process .
-
-###24699550
-OBJECTIVE	We aimed to investigate the effects of verapamil and adenosine in an adjunct to intravenous tirofiban on management and prognosis of no-reflow phenomenon during primary percutaneous coronary intervention ( PPCI ) and to compare their efficacies on reversing of no-reflow phenomenon and short and midterm survival .
-METHODS	We included 46 patients with acute ST-segment elevation myocardial infarction ( STEMI ) and occurrence of no-reflow phenomenon after PPCI .
-METHODS	All patients received intravenous tirofiban and then randomized into one of the following 3 groups : intracoronary adenosine ( N. = 16 ) , intracoronary verapamil ( N. = 15 ) or placebo ( N. = 15 ) .
-RESULTS	Intracoronary verapamil therapy had significant effect in restoring impaired coronary blood flow by decreasing thrombolysis in myocardial infarction ( TIMI ) frame count from 7344 to 5248 ( P = 0.024 ) .
-RESULTS	However , adenosine and serum physiologic administration were not found to be so effective in decreasing TIMI frame count ( from 8135 to 7146 , P = 0.084 ; from 7432 to 7137 , P = 0.612 , respectively ) .
-RESULTS	In-hospital and 6-month survival rates were similar among groups .
-CONCLUSIONS	In conclusion , intracoronary verapamil restored the impaired coronary blood flow more effectively than adenosine or placebo .
-CONCLUSIONS	However , none of them has changed the clinical course in the first 6 months .
-
-###25440375
-BACKGROUND	Dyslipidemia is an established feature of metabolic syndrome ( MS ) that is associated with an increased risk of atherosclerotic cardiovascular disease .
-BACKGROUND	Curcuminoids are natural products with anti-atherosclerotic and lipid-modifying effects but their efficacy in patients with MS has not yet been tested .
-OBJECTIVE	To investigate the effects of bioavailability-enhanced curcuminoids , as adjunctive to standard of care , on serum lipid concentrations in patients with MS.
-METHODS	Patients diagnosed with MS according to the NCEP-ATPIII criteria who were receiving standard of care were assigned to either curcuminoids ( C3 complex ( ) ; 1000 mg/day ; n = 50 ) or placebo ( n = 50 ; matched with drug capsules in shape and color ) for 8 weeks .
-METHODS	In order to improve the oral bioavailability , curcuminoids were co-administered with piperine ( bioperine ( ) ) in a ratio of 100:1 .
-METHODS	Serum concentrations of total cholesterol , low-density lipoprotein cholesterol ( LDL-C ) , high-density lipoprotein cholesterol ( HDL-C ) , triglycerides , small dense LDL ( sdLDL ) , lipoprotein ( a ) [ Lp ( a ) ] , and non-HDL-C were determined at baseline and at the end of 8-week treatment period .
-RESULTS	Curcuminoids were more effective than placebo in reducing serum LDL-C , non-HDL-C , total cholesterol , triglycerides and Lp ( a ) , and elevating HDL-C concentrations .
-RESULTS	However , changes in serum sdLDL levels were found to be comparable between the study groups .
-RESULTS	The effects of curcuminoids on triglycerides , non-HDL-C , total cholesterol and Lp ( a ) remained significant after adjustment for baseline values of lipids and body mass index .
-CONCLUSIONS	Curcuminoids-piperine combination is an efficacious adjunctive therapy in patients with MS and can modify serum lipid concentrations beyond what is achieved with standard of care .
-
-###24549966
-OBJECTIVE	A few studies focused on the methods of treatment for displaced distal tibial shaft fractures have been published , all of which compared two different methods .
-OBJECTIVE	In this randomized , prospective study , we aimed to compare minimally invasive plate osteosynthesis , locking intramedullary nail stabilization and external fixation combined with limited open reduction and absorbable internal fixation for distal tibial shaft fractures by assessing complications and secondary procedures .
-METHODS	From November 2002 to June 2012 , 137 skeletally mature patients with displaced distal tibial shaft fractures with or without fibula fracture were randomized to be treated by minimally invasive plate osteosynthesis ( group A , n = 46 ) , locking intramedullary nail ( group B , n = 46 ) or external fixation combined with limited open reduction and absorbable internal fixation ( group C , n = 45 ) .
-METHODS	Age , gender , mechanism of injury , fracture pattern and presence of open fracture were equally distributed among the three groups .
-METHODS	Indexes for evaluation included hospital stay , operative time , time to radiographic union , union status , infection and the incidence of re-operation .
-METHODS	Mazur ankle score was introduced for functional evaluation .
-METHODS	Statistics Analysis System ( SAS ) 9.2 was used for analysis .
-RESULTS	A total of 121 patients were included in the final analysis ( group A 42 , group B 40 and group C 39 ) and evaluated after a mean of 14.8 months follow-up .
-RESULTS	There was no significant difference ( P > 0.05 ) in hospital stay , time to radiographic union and the incidence of union status among the three groups .
-RESULTS	Although group C was associated with less secondary procedures versus groups A and B , it was related with more pin tract infections ( 15.4 % ) .
-RESULTS	Anterior knee pain occurred frequently after locking intramedullary nailing ( 37.5 % ) and the irritation symptoms were more frequently encountered in group A ( 59.5 % ) .
-RESULTS	There was no difference in ankle function between the three methods after operation ( P > 0.05 ) .
-CONCLUSIONS	We consider that the minimally invasive plate osteosynthesis , locking intramedullary nail stabilization and external fixation combined with limited open reduction and absorbable internal fixation techniques are all efficient methods for treating distal tibia fractures .
-CONCLUSIONS	With its wide indications , external fixation combined with limited open reduction and absorbable internal fixation leads to minimal soft tissue complication , good functional result and no local soft tissue irritation or implant removal .
-
-###24439640
-OBJECTIVE	To examine the effects of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients .
-METHODS	This was a double-blind , randomized controlled study of children undergoing dental procedures .
-METHODS	Participants were randomly assigned to receive either Reiki therapy or the control therapy ( sham Reiki ) preoperatively .
-METHODS	Postoperative pain scores , opioid requirements , and side effects were assessed .
-METHODS	Family members were also asked about perioperative care satisfaction .
-METHODS	Multiple linear regressions were used for analysis .
-RESULTS	Thirty-eight children participated .
-RESULTS	The blinding procedure was successful .
-RESULTS	No statistically significant difference was observed between groups on all outcome measures .
-CONCLUSIONS	Our study provides a successful example of a blinding procedure for Reiki therapy among children in the perioperative period .
-CONCLUSIONS	This study does not support the effectiveness of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients .
-
-###24308572
-BACKGROUND	A better understanding of interrelations of exercise and improved eating , and their psychosocial correlates of self-efficacy , mood , and self-regulation , may be useful for the architecture of improved weight loss treatments .
-BACKGROUND	Theory-based research within field settings , with samples possessing high probabilities of health risks , might enable rapid application of useful findings .
-METHODS	Adult volunteers with severe obesity ( body mass index [ BMI ] 35-50 kg/m ; age = 43.0 9.5 y ; 83 % female ) were randomly assigned to six monthly cognitive-behavioral exercise support sessions paired with either group-based nutrition education ( n = 145 ) or cognitive behavioral methods applied to improved eating ( n = 149 ) .
-METHODS	After specification of mediation models using a bias-corrected bootstrapping procedure , a series of reciprocal effects analyses assessed : a ) the reciprocal effects of changes in exercise and fruit and vegetable intake , resulting from the treatments , b ) the reciprocal effects of changes in the three psychosocial variables tested ( i.e. self-efficacy , mood , and self-regulation ) and fruit and vegetable change , resulting from change in exercise volume , and c ) the reciprocal effects of changes in the three psychosocial variables and exercise change , resulting from change in fruit and vegetable intake .
-RESULTS	Mediation analyses suggested a reciprocal effect between changes in exercise volume and fruit and vegetable intake .
-RESULTS	After inclusion of psychosocial variables , also found were reciprocal effects between change in fruit and vegetable intake and change in mood , self-efficacy for controlled eating , and self-regulation for eating ; and change in exercise volume and change in mood and exercise-related self-regulation .
-CONCLUSIONS	Findings had implications for behavioral weight-loss theory and treatment .
-CONCLUSIONS	Specifically , results suggested that treatments should focus upon , and leverage , the transfer effects from each of the primary weight-loss behaviors ( exercise and healthy eating ) to the other .
-CONCLUSIONS	Findings on psychosocial correlates of these behavioral processes may also have practical applications .
-
-###25805405
-BACKGROUND	Accruing evidence suggests that positive imagery-based cognitive bias modification ( CBM ) could have potential as a standalone targeted intervention for depressive symptoms or as an adjunct to existing treatments .
-BACKGROUND	We sought to establish the benefit of this form of CBM when delivered prior to Internet cognitive behavioral therapy ( iCBT ) for depression
-METHODS	A randomized controlled trial ( RCT ) of a 1-week Internet-delivered positive CBM vs. an active control condition for participants ( N = 75 , 69 % female , mean age = 42 ) meeting diagnostic criteria for major depression ; followed by a 10-week iCBT program for both groups .
-RESULTS	Modified intent-to-treat marginal and mixed effect models demonstrated no significant difference between conditions following the CBM intervention or the iCBT program .
-RESULTS	In both conditions there were significant reductions ( Cohens d .57 -1.58 , 95 % CI = .12 -2.07 ) in primary measures of depression and interpretation bias ( PHQ9 , BDI-II , AST-D ) .
-RESULTS	Large effect size reductions ( Cohens d .81 -1.32 , 95 % CI = .31 -1.79 ) were observed for secondary measures of distress , disability , anxiety and repetitive negative thinking ( K10 , WHODAS , STAI , RTQ ) .
-RESULTS	Per protocol analyses conducted in the sample of participants who completed all seven sessions of CBM indicated between-group superiority of the positive over control group on depression symptoms ( PHQ9 , BDI-II ) and psychological distress ( K10 ) following CBM ( Hedges g .55 -.88 , 95 % CI = -.03 -1.46 ) and following iCBT ( PHQ9 , K10 ) .
-RESULTS	The majority ( > 70 % ) no longer met diagnostic criteria for depression at 3-month follow-up .
-CONCLUSIONS	The control condition contained many active components and therefore may have represented a smaller ` dose ' of the positive condition .
-CONCLUSIONS	Results provide preliminary support for the successful integration of imagery-based CBM into an existing Internet-based treatment for depression .
-
-###25776953
-OBJECTIVE	Nonsevere relapses are more common than severe relapses in antineutrophil cytoplasmic antibody ( ANCA ) - associated vasculitis ( AAV ) , but their clinical course and treatment outcomes remain largely unexamined .
-OBJECTIVE	We undertook this study to analyze the outcomes of patients with nonsevere relapses in the Rituximab in ANCA-Associated Vasculitis ( RAVE ) trial who were treated with prednisone according to a prespecified protocol .
-METHODS	RAVE was a randomized , double-blind , placebo-controlled trial comparing rituximab ( RTX ) to cyclophosphamide ( CYC ) followed by azathioprine ( AZA ) for induction of remission .
-METHODS	Patients who experienced nonsevere relapses between months 1 and 18 were treated with a prednisone increase without a concomitant change in their nonglucocorticoid immunosuppressants , followed by a taper .
-RESULTS	Forty-four patients with a first nonsevere relapse were analyzed .
-RESULTS	In comparison to the 71 patients who maintained relapse-free remission over 18 months , these patients were more likely to have proteinase 3-ANCAs , diagnoses of granulomatosis with polyangiitis ( Wegener 's ) , and a history of relapsing disease at baseline .
-RESULTS	A prednisone increase led to remission in 35 patients ( 80 % ) .
-RESULTS	However , only 13 patients ( 30 % ) were able to maintain second remissions through the followup period ( mean 12.5 months ) ; 31 patients ( 70 % ) had a second disease relapse , 14 of them with severe disease .
-RESULTS	The mean time to second relapse was 9.4 months ( 4.7 months in the group treated with RTX versus 13.7 months in the group treated with CYC/AZA ; P < 0.01 ) .
-RESULTS	Patients who experienced nonsevere relapses received more glucocorticoids than those who maintained remission ( 6.7 grams versus 3.8 grams ; P < 0.01 ) .
-CONCLUSIONS	Treatment of nonsevere relapses in AAV with an increase in glucocorticoids is effective in restoring temporary remission in the majority of patients , but recurrent relapses within a relatively short interval remain common .
-CONCLUSIONS	Alternative treatment approaches are needed for this important subset of patients .
-
-###24679695
-BACKGROUND	The incidence of alkaline reflux gastritis ( ARG ) after pancreaticoduodenectomy ( PD ) is high .
-BACKGROUND	Although Braun enteroenterostomy ( BEE ) may reduce ARG , BEE may result in marginal ulcers ( MUs ) due to the additional anastomotic stoma .
-BACKGROUND	We conducted this study to compare clinical outcomes of using a modified BEE ( MBEE ) with traditional gastrojejunostomy ( TGJ ) , by inducting a purse-string suture instead of an additional anastomotic stoma .
-METHODS	All 62 patients underwent standard PD at the Department of Hepatobiliopancreatic Surgery of West China Hospital between January 1 , 2008 and January 31 , 2012 .
-METHODS	Demographics , perioperative and postoperative factors , and follow-up morbidity were compared in those patients who underwent MBEE ( n = 32 , three patients were lost to follow-up ) to those who underwent TGJ ( n = 30 , nine patients were lost to follow-up ) .
-RESULTS	Patients who underwent the MBEE experienced a decrease in total morbidity including ARG and MUs , relative to those who underwent TGJ ( 24.1 % versus 58.3 % , P = 0.011 ) .
-RESULTS	With regard to the MBEE group , the total ARG rate was statistically significantly lower compared with the TGJ group ( 13.8 % versus 37.5 % , P = 0.046 ) .
-RESULTS	In addition , the incidence of MUs was reduced .
-CONCLUSIONS	In patients undergoing PD , the MBEE was safely performed with significantly more patients having reduced incidence of ARG and related sequela compared with those who underwent TGJ .
-CONCLUSIONS	These results support further study of patients undergoing gastroenterostomy after resection of the distal stomach in larger , randomized studies .
-
-###25659357
-OBJECTIVE	To assess the effect of platelet-rich fibrin ( PRF ) on postoperative pain , swelling , trismus , periodontal healing on the distal aspect of the secondmolar , and progress of bone regeneration in mandibular third molar extraction sockets .
-METHODS	Over a 2-year period , 31 patients ( mean age , 26.1 yr ) who required surgical extraction of a single impacted third molar and met the inclusion criteria were recruited .
-METHODS	After surgical extraction of the third molar , only primary closure was performed in the control group , whereas PRF was placed in the socket followed by primary closure in the case group ( 16 patients ) .
-METHODS	The outcome variables were pain , swelling , maximum mouth opening , periodontal pocket depth , and bone formation , with a follow-up period of 3months .
-METHODS	Quantitative data are presented as mean .
-METHODS	Statistical significance was inferred at a P value less than .05 .
-RESULTS	Pain ( P = .017 ) , swelling ( P = .022 ) , and interincisal distance ( P = .040 ) were less in the case group compared with the control group on the first postoperative day .
-RESULTS	Periodontal pocket depth decreased at 3months postoperatively in the case ( P < .001 ) and control ( P = .014 ) groups , and this decrease was statistically significant .
-RESULTS	Bone density scores at 3months postoperatively were higher in the case group than in the control group , but this difference was not statistically important .
-CONCLUSIONS	The application of PRF lessens the severity of immediate postoperative sequelae , decreases preoperative pocket depth , and hastens bone formation .
-
-###24886338
-BACKGROUND	Vertigo is a common medical condition with a broad spectrum of diagnoses which requires an integrated approach to patients through a structured clinical interview and physical examination .
-BACKGROUND	The main cause of vertigo in primary care is benign paroxysmal positional vertigo ( BPPV ) , which should be confirmed by a positive D-H positional test and treated with repositioning maneuvers .
-BACKGROUND	The objective of this study is to evaluate the effectiveness of Epley 's maneuver performed by general practitioners ( GPs ) in the treatment of BPPV .
-METHODS	This study is a randomized clinical trial conducted in the primary care setting .
-METHODS	The study 's scope will include two urban primary care centers which provide care for approximately 49,400 patients .
-METHODS	All patients attending these two primary care centers , who are newly diagnosed with benign paroxysmal positional vertigo , will be invited to participate in the study and will be randomly assigned either to the treatment group ( Epley 's maneuver ) or to the control group ( a sham maneuver ) .
-METHODS	Both groups will receive betahistine .
-METHODS	Outcome variables will be : response to the D-H test , patients ' report on presence or absence of vertigo during the previous week ( dichotomous variable : yes/no ) , intensity of vertigo symptoms on a Likert-type scale in the previous week , total score on the Dizziness Handicap Inventory ( DHI ) and quantity of betahistine taken .
-CONCLUSIONS	Positive results from our study will highlight that treatment of benign paroxysmal positional vertigo can be performed by trained general practitioners ( GPs ) and , therefore , its widespread practice may contribute to improve the quality of life of BPPV patients .
-BACKGROUND	ClinicalTrials.gov Identifier : NCT01969513 .
-
-###24296288
-OBJECTIVE	The aim of this study was to develop an accurate robust testing method to simultaneously measure urine levels of HVA and VMA using gas chromatography mass spectrometry ( GCMS ) and to establish age-specific reference intervals of HVA and VMA in random urines for Vietnamese children .
-METHODS	The assay for urinary HVA and VMA was developed based on a classical urinary organic acid profiling method .
-METHODS	Briefly , this incorporated 3-phenyl butyric acid as the internal standard and liquid-liquid extraction with ethyl acetate followed by derivatization with BSTFA .
-METHODS	The Agilent 7890A GC and 5975C Mass Selective Detector in single ion monitoring mode was used for analysis .
-METHODS	Reference intervals were developed from random urine samples collected from 634 disease free Vietnamese children and compared to 50 known neuroblastoma patient samples .
-METHODS	Results were reported relative to creatinine concentration .
-METHODS	Age related 95 % reference intervals for urinary HVA and VMA were estimated from sample quantiles .
-METHODS	The analytes ( expressed as analyte/creatinine ratios ) diagnostic values were determined by calculating the related sensitivity , specificity and likelihood ratios .
-RESULTS	HVA and VMA were linear to at least 193 and 221mol/L , respectively .
-RESULTS	The limit of quantitation for both analytes was 0.9 mol/L .
-RESULTS	Using the bi-level control ( n = 15 ) , the within-batch coefficients of variations ( CVs ) were less than 3 % for both analytes across the assay range .
-RESULTS	The between-batch CVs ( n = 20 over three months ) , were 3.6 % at 11mol/L and 2.1 % at 88mol/L for HVA , 6.6 % at 18.2 mol/L and 2.6 % at 90.6 mol/L for VMA .
-RESULTS	Vietnamese age related reference intervals were established for urinary HVA and VMA per creatinine .
-RESULTS	HVA for children < 6months ( n = 91 ) was 5.3-37 .0 mol/mmol ; 6months to < 1year ( n = 141 ) was 2.7-27 .7 mol/mmol ; 1 to 5years ( n = 139 ) was 3.4-17 .9 mol/mmol ; 6 to 10years ( n = 136 ) was 2.7-8 .8 mol/mmol ; and 11 to 15years ( n = 127 ) was 1.1-9 .4 mol/mmol .
-RESULTS	VMA for children < 6months was 1.8-12 .2 mol/mmol ; 6months to < 1year was 1.5-9 .3 mol/mmol ; 1 to 5years was 1.9-7 .8 mol/mmol ; 6 to 10years was 1.6-5 .1 mol/mmol ; and 11 to 15years was < 0.9-6 .3 mol/mmol .
-CONCLUSIONS	A robust testing method for simultaneous quantitation of urinary HVA and VMA by GCMS was developed .
-CONCLUSIONS	This method is accurate , precise and fit for its clinical purpose and suitable for developing countries .
-CONCLUSIONS	Age-related reference intervals of urinary HVA and VMA were established for Vietnamese children and the intervals declined progressively with increasing age for each analyte .
-
-###24511648
-BACKGROUND	Contrast-induced nephropathy ( CIN ) is one of the major causes of new-onset renal failure in hospitalized patients .
-BACKGROUND	Although renin-angiotensin-aldosterone system ( RAAS ) blocking agents are widely used among patients requiring contrast studies , data on the effect of these agents on the development of CIN are sparse and inconsistent .
-OBJECTIVE	To evaluate in a randomized controlled trial whether uninterrupted administration of angiotensin II ( AnglI ) blockade medications influence estimated glomerular filtration rate ( eGFR ) in patients undergoing non-emergent coronary angiography .
-METHODS	Patients receiving treatment with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers ( ACE-I/ARB ) were recruited consecutively .
-METHODS	The enrolled subjects were randomized into three groups at a 1:1:1 ratio : group A ( ACE/ARB stopped 24 hours prior to the procedure and restarted immediately after the procedure ) , group B ( ACE/ARB stopped 24 hours prior to the procedure and restarted 24 hours after the procedure ) , and group C ( ACE/ARB continued throughout the study period ) .
-METHODS	Plasma creatinine was measured and eGFR was calculated according to the Cockroft-Gault equation before and 48 hours after the coronary angiography .
-METHODS	The primary endpoint was a change in eGFR at 48 hours .
-RESULTS	Groups A , B and C comprised 30 , 31 and 33 patients respectively .
-RESULTS	The mean age of the study population was 65 + / - 12 years and 67 % were males .
-RESULTS	Fifty percent of the subjects had diabetes mellitus .
-RESULTS	The primary endpoint analysis showed that at 48 hours after the procedure there was no difference in delta eGFR between groups A and C ( 4.25 + / - 12.19 vs. 4.65 + / - 11.76 , P = 0.90 ) and groups B and C ( 3.72 + / - 17.42 vs. 4.65 + / - 11.76 , P = 0.82 ) .
-RESULTS	In post-hoc analysis the patients were clustered according to the following groups : medical alternation ( group A and B ) versus control ( group C ) , and to baseline eGFR > or = 60 ml/min vs. eGFR ( < 60 ml/min .
-RESULTS	In patients with baseline eGFR < 60 ml/min the delta eGFR ( baseline eGFR-eGFR 48 hours post-angiography ) was significantly different between the intervention vs. control group ( median 5.61 vs. median -2.19 , P = 0.03 respectively ) .
-RESULTS	While in patients with baseline eGFR > or = 60 ml/min there was no significant difference in delta eGFR between the intervention and control groups .
-CONCLUSIONS	ACE-I and ARB can safely be used before and after coronary angiography in patients with eGFR > or = 60 ml/min .
-
-###25731690
-OBJECTIVE	The purpose of this study was to investigate the use of vaginal progesterone for the prevention of preterm delivery in twin pregnancies .
-METHODS	We conducted a prospective , randomized , double-blind , placebo-controlled trial that involved 390 naturally conceived twin pregnancies among mothers with no history of preterm delivery who were receiving antenatal care at a single center .
-METHODS	Women with twin pregnancies between 18 and 21 weeks and 6 days ' gestation were assigned randomly to daily vaginal progesterone ( 200 mg ) or placebo ovules until 34 weeks and 6 days ' gestation .
-METHODS	The primary outcome was the difference in mean gestational age at delivery ; the secondary outcomes were the rate of spontaneous delivery at < 34 weeks ' gestation and the rate of neonatal composite morbidity and mortality in the treatment and nontreatment groups .
-RESULTS	The baseline characteristics were similar in both groups .
-RESULTS	The final analysis included 189 women in the progesterone group and 191 in the placebo group .
-RESULTS	No difference ( P = .095 ) in the mean gestational age at delivery was observed between progesterone ( 35.08 3.19 [ SD ] ) and placebo groups ( 35.55 2.85 ) .
-RESULTS	The incidence of spontaneous delivery at < 34 weeks ' gestation was 18.5 % in the progesterone group and 14.6 % in the placebo group ( odds ratio , 1.32 ; 95 % confidence interval , 0.24-2 .37 ) .
-RESULTS	No difference in the composite neonatal morbidity and mortality was observed between the progesterone ( 15.5 % ) and placebo ( 15.9 % ) groups ( odds ratio , 1.01 ; 95 % confidence interval , 0.58-1 .75 ) .
-CONCLUSIONS	In nonselected twin pregnancies , vaginal progesterone administration does not prevent preterm delivery and does not reduce neonatal morbidity and death .
-
-###24614995
-OBJECTIVE	To investigate the effect of Vitamin D3 on physical performance in patients with HF .
-BACKGROUND	HF is associated with functional decline and frailty .
-BACKGROUND	Vitamin D deficiency is associated with loss of muscle strength and poor outcomes in patients with HF .
-METHODS	Sixty-four patients participated in a 6-month parallel design double blind RCT to test the hypothesis that oral vitamin D3 would improve physical performance .
-METHODS	Vitamin D3 50,000 IU or placebo was given weekly ; all received daily calcium .
-METHODS	Patients were included regardless of EF and 25OHD 37.5 ng/ml .
-METHODS	The primary outcome was peak VO2 , and secondary outcomes were the 6MW , TGUG and knee isokinetic muscle strength .
-METHODS	Between group comparisons were made using ANCOVA models that adjust for baseline measures .
-RESULTS	Patients were age 65.9 10.4 years old , 48 % women , 64 % African American , EF 37.613.9 , 36 % NYHA III , the remainder NYHA II .
-RESULTS	At baseline the vitamin D group 25OHD was 19.1 9.3 ng/ml and increased to 61.7 20.3 ng/ml ; in the placebo group baseline 25OHD was 17.8 9.0 ng/ml and decreased to 17.4 9.8 ng/ml at 6 months ( between groups p < 0.001 ) .
-RESULTS	There was no significant change from baseline to 6 months in peak VO2 , 6MW , TGUG or isokinetic muscle strength .
-CONCLUSIONS	Vitamin D3 did not improve physical performance for patients with HF despite a robust increase in serum 25OHD .
-CONCLUSIONS	Vitamin D repletion in patients with HF should conform to standard adult guidelines for vitamin D supplementation .
-
-###24477039
-BACKGROUND	In nutritional studies , pigs are often used as models for humans because of nutritional and physiologic similarities .
-BACKGROUND	However , evidence supporting similar metabolic responses to nutritional interventions is lacking .
-OBJECTIVE	The objective was to establish whether pigs and humans respond similarly to a nutritional intervention .
-OBJECTIVE	Using metabolomics , we compared the acute metabolic response to 4 test breads between conventional pigs ( growing ) and adult human subjects ( with the metabolic syndrome ) .
-METHODS	Six catheterized pigs and 15 human subjects were tested in a randomized crossover design with 4 breads : white-wheat bread low in dietary fiber , rye bread with whole-rye kernels , and 2 white-wheat breads supplemented with either wheat arabinoxylan or oat - glucan .
-METHODS	Blood samples drawn -15 , 30 , and 120 min postprandially were analyzed by untargeted liquid chromatography-mass spectrometry metabolomics .
-RESULTS	We found that the postprandial responses , as reflected in blood metabolomes , are similar in pigs and humans .
-RESULTS	Twenty-one of 26 identified metabolites that were found to be different between the species were qualitatively similar in response to the test breads , despite different basal metabolome concentrations in the plasma of pigs and humans .
-RESULTS	Humans had higher contents of phosphatidylcholines , oleic acid , and carnitine in plasma , possibly reflecting a higher intake of meats and fats .
-RESULTS	In pigs , betaine , choline , creatinine , tryptophan , and phenylalanine were higher , probably because of the higher doses of bread provided to the pigs ( per kg body weight ) and/or because of their growing status .
-RESULTS	Acute metabolic differences in these metabolites induced by the breads were , however , comparable between the 2 species .
-CONCLUSIONS	Our results indicate that pigs are a suitable model for human metabolic studies in food research .
-CONCLUSIONS	The human trial was registered at clinicaltrials.gov as NCT01316354 .
-CONCLUSIONS	The animal experiment was conducted according to a license obtained by the Danish Animal Experiments Inspectorate , Ministry of Food , Agriculture and Fisheries , Danish Veterinary and Food Administration .
-
-###24361242
-BACKGROUND	The extent to which change in physical activity can modify the risk of cardiovascular disease in individuals at high cardiovascular risk is uncertain .
-BACKGROUND	We investigated whether baseline and change in objectively-assessed ambulatory activity is associated with the risk of a cardiovascular event in individuals at high cardiovascular risk with impaired glucose tolerance .
-METHODS	We assessed prospective data from the NAVIGATOR trial involving 9306 individuals with impaired glucose tolerance who were recruited in 40 countries between January , 2002 , and January , 2004 .
-METHODS	Participants also either had existing cardiovascular disease ( if age 50 years ) or at least one additional cardiovascular risk factor ( if age 55 years ) .
-METHODS	Participants were followed-up for cardiovascular events ( defined as cardiovascular mortality , non-fatal stroke , or myocardial infarction ) for 6 years on average and had ambulatory activity assessed by pedometer at baseline and 12 months .
-METHODS	Adjusted Cox proportional hazard models quantified the association of baseline and change in ambulatory activity ( from baseline to 12 months ) with the risk of a subsequent cardiovascular event , after adjustment for each other and potential confounding variables .
-METHODS	This study is registered with ClinicalTrials.govNCT00097786 .
-RESULTS	During 45,211 person-years follow-up , 531 cardiovascular events occurred .
-RESULTS	Baseline ambulatory activity ( hazard ratio [ HR ] per 2000 steps per day 090 , 95 % CI 084-096 ) and change in ambulatory activity ( 092 , 086-099 ) were inversely associated with the risk of a cardiovascular event .
-RESULTS	Results for change in ambulatory activity were unaffected when also adjusted for changes in body-mass index and other potential confounding variables at 12 months .
-CONCLUSIONS	In individuals at high cardiovascular risk with impaired glucose tolerance , both baseline levels of daily ambulatory activity and change in ambulatory activity display a graded inverse association with the subsequent risk of a cardiovascular event .
-BACKGROUND	Novartis Pharmaceuticals .
-
-###25282520
-BACKGROUND	Homozygous familial hypercholesterolaemia is a rare , serious disorder caused by very low or absent plasma clearance of LDL , substantially raised LDL cholesterol , and accelerated development of cardiovascular disease .
-BACKGROUND	Conventional lipid-lowering treatments are modestly effective .
-BACKGROUND	Evolocumab , a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) , reduced LDL cholesterol by 16 % in a pilot study .
-BACKGROUND	We now report results with evolocumab in a randomised , double-blind , placebo-controlled phase 3 trial .
-METHODS	This randomised , double-blind , placebo-controlled phase 3 trial was undertaken at 17 sites in ten countries in North America , Europe , the Middle East , and South Africa .
-METHODS	50 eligible patients ( aged 12 years ) with homozygous familial hypercholesterolaemia , on stable lipid-regulating therapy for at least 4 weeks , and not receiving lipoprotein apheresis , were randomly allocated by a computer-generated randomisation sequence in a 2:1 ratio to receive subcutaneous evolocumab 420 mg or placebo every 4 weeks for 12 weeks .
-METHODS	Randomisation was stratified by LDL cholesterol at screening ( < 11 mmol/L or 11 mmol/L ) and implemented by a computerised interactive voice-response system .
-METHODS	Patients , study personnel , and the funder were masked to treatment and to the efficacy results by the central laboratory not returning LDL cholesterol or any lipid results to the clinical sites after the baseline visit .
-METHODS	The primary endpoint was percentage change in ultracentrifugation LDL cholesterol from baseline at week 12 compared with placebo , analysed by intention-to-treat .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT01588496 .
-RESULTS	Of the 50 eligible patients randomly assigned to the two treatment groups , 49 actually received the study drug and completed the study ( 16 in the placebo group and 33 in the evolocumab group ) .
-RESULTS	Compared with placebo , evolocumab significantly reduced ultracentrifugation LDL cholesterol at 12 weeks by 309 % ( 95 % CI -439 % to -180 % ; p < 00001 ) .
-RESULTS	Treatment-emergent adverse events occurred in ten ( 63 % ) of 16 patients in the placebo group and 12 ( 36 % ) of 33 in the evolocumab group .
-RESULTS	No serious clinical or laboratory adverse events occurred , and no anti-evolocumab antibody development was detected during the study .
-CONCLUSIONS	In patients with homozygous familial hypercholesterolaemia receiving stable background lipid-lowering treatment and not on apheresis , evolocumab 420 mg administered every 4 weeks was well tolerated and significantly reduced LDL cholesterol compared with placebo .
-BACKGROUND	Amgen Inc. .
-
-###25232073
-BACKGROUND	Dynamic rehabilitation has been suggested to be an important part of nonoperative treatment of acute Achilles tendon rupture that results in functional outcome and rerupture rates comparable with those of operative treatment .
-BACKGROUND	However , the optimal role of weight-bearing during early rehabilitation remains unclear .
-BACKGROUND	The purpose of this study was to compare immediate weight-bearing with non-weight-bearing in a nonoperative dynamic treatment protocol for Achilles tendon rupture .
-METHODS	The study was conducted as a blinded , randomized , controlled , parallel superiority trial .
-METHODS	Patients eighteen to sixty years of age were eligible for inclusion .
-METHODS	Both groups were treated nonoperatively with controlled early motion .
-METHODS	The intervention group was allowed full weight-bearing from day one , and the control group was non-weight-bearing for six weeks .
-METHODS	The primary outcome was the Achilles tendon Total Rupture Score ( ATRS ) after one year .
-METHODS	Secondary outcomes included heel-rise work , health-related quality of life , and the rerupture rate .
-METHODS	Outcome assessors were blinded to the intervention .
-RESULTS	Thirty patients were randomized to each group ; twenty-nine in the weight-bearing group and twenty-seven in the control group were analyzed .
-RESULTS	The only significant difference between the groups was better health-related quality of life in the weight-bearing group at twelve months ( p = 0.009 ) .
-RESULTS	The mean ATRS at twelve months was 73 in the weight-bearing group and 74 in the control group ( p = 0.81 ) .
-RESULTS	At twelve months , the total heel-rise work performed by the injured limb relative to that by the uninjured limb was 53 % in the weight-bearing group and 58 % in the control group ( p = 0.37 ) .
-RESULTS	There were three reruptures in the weight-bearing group and two in the control group ( p = 1.0 ) .
-CONCLUSIONS	The ATRS and heel-rise work results did not differ significantly between the groups .
-CONCLUSIONS	The rerupture rate was 9 % overall , and both groups had substantial functional deficits in the injured limb compared with the uninjured limb .
-CONCLUSIONS	Immediate weight-bearing can be recommended as an option in the nonoperative treatment of Achilles tendon rupture .
-
-###25091954
-BACKGROUND	To evaluate the potential efficacy and safety of inner limiting membrane ( ILM ) staining with brilliant blue G ( BBG ) under air infusion .
-METHODS	63 patients , treated by one surgeon with macular hole or idiopathic epiretinal membrane were evaluated prospectively .
-METHODS	BBG was applied under air infusion in 38 patients ( group 1 ) , and injected into the vitreous cavity in 25 ( group 2 ) .
-METHODS	Main outcome measures were the chromaticity difference between the stained ILM and the unstained underlying retina , anatomical-functional outcomes and complications of the surgery .
-METHODS	Chromaticity difference was measured by an objective and quantitative analysis method to describe colour contrast strengths as they are perceived by the human eye .
-METHODS	Anatomical and functional outcomes were assessed using optical coherence tomography ( OCT ) , visual field analyses ( VFA ) and multifocal electroretinography ( mfERG ) .
-RESULTS	CIELAB scores showed a significantly superior contrast for group 1 ( 16.722.36 ) than group 2 ( 10.341.29 ) ( p < 0.001 ) .
-RESULTS	Visual acuity had increased in 28 eyes and remained stable in 10 eyes in group 1 .
-RESULTS	In group 2 , visual acuity had improved in 17 patients and remained unchanged in 8 patients .
-RESULTS	Based on postoperative OCT , anatomical success rate was 100 % .
-RESULTS	During the follow-up period , mfERG and VFA demonstrated no case of BBG toxicity in either group .
-RESULTS	Cataract progression was the main postoperative complication ( six eyes in group 1 and four eyes in group 2 ) and did not show a significant difference between the groups ( p = 0.45 ) .
-CONCLUSIONS	BBG under air infusion yields a significantly higher contrast staining and easy peeling of ILM associated with anatomical and functional improvement and no retinal toxicity after macular surgery .
-
-###24559642
-OBJECTIVE	To investigate whether a home-based rehabilitation program for community-dwelling older people with recent hip fracture is more effective than standard care in improving mobility recovery and reducing disability .
-METHODS	Randomized , controlled , parallel-group trial .
-METHODS	Rehabilitation in participants ' homes ; measurements in university-based laboratory and local hospital .
-METHODS	Clinical population of community-dwelling men and women ( aged 60 + ) recovering from hip fracture .
-METHODS	Participants were randomly assigned into control ( n = 41 ) or intervention ( n = 40 ) groups on average 42 23 days after discharge home .
-METHODS	A yearlong multicomponent home-based rehabilitation aimed at promoting mobility recovery and physical functional capacity after hip fracture .
-METHODS	The intervention included evaluation and modification of environmental hazards , guidance for safe walking , nonpharmacological pain management , a progressive home exercise program , physical activity counseling , and standard care .
-METHODS	Measurements were outlined according to the tiers of the disablement process , with the ability to negotiate stairs as the main outcome .
-METHODS	Prefracture ability to negotiate stairs was enquired at the hospital on average 10 5 days after fracture .
-METHODS	Subsequently , current perceived ability to negotiate stairs was reported immediately before the intervention ( on average 9 weeks after surgery ) and 3 , 6 , and 12 months thereafter .
-METHODS	Other measurements included leg extension power deficit ( LEP ) , functional balance ( Berg Balance Scale ) and lower extremity performance ( Short Physical Performance Battery ) .
-METHODS	Effects of the intervention were analyzed with generalized estimation equations and longitudinal repeated measures mixture path models .
-RESULTS	The intervention reduced perceived difficulties in negotiating stairs ( interaction , group time P = .001 ) from prefracture to 12 months compared with the control condition .
-RESULTS	The mixture path model revealed that less difficulty in negotiating stairs at 6 and 12 months correlated with better functional balance at 3 and 6 months in the intervention group but not controls ( group difference P = .007 and P < .001 , respectively ) .
-CONCLUSIONS	The individualized home-based rehabilitation program improved mobility recovery after hip fracture over standard care .
-CONCLUSIONS	To be efficacious in reducing or reversing disability after hip fracture , rehabilitation needs to be individualized , include many components , be progressive , and span a sufficiently long period .
-CONCLUSIONS	Current Controlled Trials ( ISRCTN53680197 ) .
-
-###24671165
-OBJECTIVE	Patients leaving residential treatment for alcohol use disorders are not typically offered evidence-based continuing care , although research suggests that continuing care is associated with better outcomes .
-OBJECTIVE	A smartphone-based application could provide effective continuing care .
-OBJECTIVE	To determine whether patients leaving residential treatment for alcohol use disorders with a smartphone application to support recovery have fewer risky drinking days than control patients .
-METHODS	An unmasked randomized clinical trial involving 3 residential programs operated by 1 nonprofit treatment organization in the Midwestern United States and 2 residential programs operated by 1 nonprofit organization in the Northeastern United States .
-METHODS	In total , 349 patients who met the criteria for DSM-IV alcohol dependence when they entered residential treatment were randomized to treatment as usual ( n = 179 ) or treatment as usual plus a smartphone ( n = 170 ) with the Addiction-Comprehensive Health Enhancement Support System ( A-CHESS ) , an application designed to improve continuing care for alcohol use disorders .
-METHODS	Treatment as usual varied across programs ; none offered patients coordinated continuing care after discharge .
-METHODS	A-CHESS provides monitoring , information , communication , and support services to patients , including ways for patients and counselors to stay in contact .
-METHODS	The intervention and follow-up period lasted 8 and 4 months , respectively .
-METHODS	Risky drinking days -- the number of days during which a patient 's drinking in a 2-hour period exceeded 4 standard drinks for men and 3 standard drinks for women , with standard drink defined as one that contains roughly 14 g of pure alcohol ( 12 oz of regular beer , 5 oz of wine , or 1.5 oz of distilled spirits ) .
-METHODS	Patients were asked to report their risky drinking days in the previous 30 days on surveys taken 4 , 8 , and 12 months after discharge from residential treatment .
-RESULTS	For the 8 months of the intervention and 4 months of follow-up , patients in the A-CHESS group reported significantly fewer risky drinking days than did patients in the control group , with a mean of 1.39 vs 2.75 days ( mean difference , 1.37 ; 95 % CI , 0.46-2 .27 ; P = .003 ) .
-CONCLUSIONS	The findings suggest that a multifeatured smartphone application may have significant benefit to patients in continuing care for alcohol use disorders .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01003119 .
-
-###24359618
-BACKGROUND	Hemostasis in thyroid surgery is of utmost importance for a successful surgery and an uneventful postoperative course .
-BACKGROUND	Our aim was to evaluate the effectiveness of the FOCUS Harmonic Scalpel in patients undergoing open total thyroidectomy .
-METHODS	In this study , 778 patients were randomized into 2 groups based on the surgical technique used : group I comprised the conventional clamp-and-tie technique , group II comprised patients in whom the FOCUS Harmonic Scalpel was used exclusively .
-METHODS	The groups were compared in regard to surgical time , complications , and hospital stay .
-RESULTS	Surgical time was significantly lower in group II compared with group I ( 7921.5 min vs. 12530.4 , respectively , P < 0.001 ) .
-RESULTS	Twenty-seven patients ( 6.94 % ) in group I experienced symptomatic hypocalcemia requiring calcium and/or vitamin D therapy versus 14 patients ( 3.6 % ) in group II , with statistically significant difference ( P < 0.05 ) .
-RESULTS	Mean post-operative hospital stay was significantly lower in group II compared with group I ( 2.60.9 vs. 2.91.0 ; P < 0.001 ) .
-CONCLUSIONS	The FOCUS Harmonic Scalpel can shorten operative time and hospital stay , reduce incidence of symptomatic hypocalcemia but not transient hypoparathyroidism , and show no significance on recurrent nerve injury .
-CONCLUSIONS	FOCUS Harmonic Scalpel is supposed to be a more reliable and safe instrument that can take place of the clamp-and-tie technique in total thyroidectomy .
-
-###24246119
-OBJECTIVE	This study aimed at evaluating the benefit of changing drug therapy in elderly patients with moderate , potentially drug-induced hyponatremia .
-METHODS	Hospitalized older adults , with moderate hyponatremia , potentially induced by drugs , were randomized into two arms : an interventional group , whose drug therapy was changed , and a reference group , which received standard care .
-METHODS	The effectiveness of the intervention was evaluated by the normalization of serum sodium after four weeks and by the incidence of falls three months later .
-RESULTS	Nineteen patients were randomized , fourteen evaluated at 4 weeks .
-RESULTS	Serum sodium was normalized more frequently in the interventional group than in the reference group : 75 % ( 6/8 ) IC95 % [ 35-97 ] versus 0 % ( 0/6 ) IC95 % [ 0-46 ] ; p = 0.01 .
-RESULTS	A greater reduction in falls occurred in the therapeutic intervention group 75 % ( 3/4 ) IC95 % [ 19-99 ] versus 0 % ( 0/5 ) IC95 % [ 0-52 ] ; p = 0.048 .
-CONCLUSIONS	This study showed the biological and clinical benefit of a pharmalogical intervention .
-CONCLUSIONS	Registration number of the study : ID RCB 2010-A00778-31 .
-
-###25241957
-BACKGROUND	Knot tying is a fundamental and crucial surgical skill .
-BACKGROUND	We developed a kinesthetic pedagogical approach that increases precision and economy of motion by explicitly teaching suture-handling maneuvers and studied its effects on novice performance .
-METHODS	Seventy-four first-year medical students were randomized to learn knot tying via either the traditional or the novel `` kinesthetic '' method .
-METHODS	After 1 week of independent practice , students were videotaped performing 4 tying tasks .
-METHODS	Three raters scored deidentified videos using a validated visual analog scale .
-METHODS	The groups were compared using analysis of covariance with practice knots as a covariate and visual analog scale score ( range , 0 to 100 ) as the dependent variable .
-METHODS	Partial eta-square was calculated to indicate effect size .
-RESULTS	Overall rater reliability was .92 .
-RESULTS	The kinesthetic group scored significantly higher than the traditional group for individual tasks and overall , controlling for practice ( all P < .004 ) .
-RESULTS	The kinesthetic overall mean was 64.15 ( standard deviation = 16.72 ) vs traditional 46.31 ( standard deviation = 16.20 ; P < .001 ; effect size = .28 ) .
-CONCLUSIONS	For novices , emphasizing kinesthetic suture handling substantively improved performance on knot tying .
-CONCLUSIONS	We believe this effect can be extrapolated to more complex surgical skills .
-
-###25794092
-OBJECTIVE	The purpose of this study was to determine whether the occurrence of numerous colonic bubbles during CT colonography ( CTC ) performed with polyethylene glycol cleansing and oral iohexol fecal/fluid tagging could be prevented by use of simethicone .
-METHODS	Adults with suspected colonic neoplasia who had been randomly assigned to control and simethicone intervention groups underwent CTC after cleansing with 4 L of polyethylene glycol , tagging with 50 mL of 350 mg I/mL oral iohexol , and without ( control ) or with ( intervention ) oral administration of 200 mg of simethicone .
-METHODS	Colonic segments in the control and intervention groups were evaluated for amount of colonic bubbles during CTC .
-METHODS	A 6-point grading system was used in which 0 indicated no bubbles and 5 indicated that more than three fourths of the air-distended mucosa was covered with bubbles .
-METHODS	The primary endpoint was a per-patient colonic bubble grade , derived as an average of the segmental grades .
-RESULTS	Eighty adults with suspected colonic neoplasia were randomly assigned to the control ( 40 patients ) and simethicone intervention ( 40 patients ) groups .
-RESULTS	A total of 659 colonic segments in the control group and 689 segments in the intervention group were evaluated for amount of colonic bubbles during CTC .
-RESULTS	The per-patient colonic bubble score was significantly lower in the simethicone intervention group than in the control group .
-RESULTS	The mean score was 0.00.1 ( SD ) versus 1.20.8 ( p < 0.001 ; 95 % CI for the mean difference , -1.4 to -1.0 ) .
-RESULTS	In the intervention group , 673 ( 97.7 % ) segments were grade 0 , and 16 ( 2.3 % ) were grade 1 .
-RESULTS	In contrast , in the control group , 226 ( 34.3 % ) segments were grade 0 ; 173 ( 26.3 % ) , grade 1 ; 175 ( 26.6 % ) , grade 2 ; 45 ( 6.8 % ) , grade 3 ; 23 ( 3.5 % ) , grade 4 ; and 17 ( 2.6 % ) , grade 5 .
-CONCLUSIONS	The colonic bubbles associated with fecal/fluid tagging with iohexol can be successfully prevented by adding simethicone to the colonic preparation .
-
-###25233645
-OBJECTIVE	To compare the difference in clinical efficacy on post-stroke sensory disturbance between catgut implantation at scalp reflecting foci and conventional acupuncture as well as the impacts on blood rheology .
-METHODS	Fifty-nine cases of post-stroke sensory disturbance were randomized into a catgut implantation group ( 30 cases ) and an acupuncture group ( 29 cases ) .
-METHODS	The conventional internal medicine treatment , limb motor function rehabilitation training and sensory function training were applied in the two groups .
-METHODS	Additionally , the catgut implantation was used at scalp reflecting foci in the catgut implantation group , once a week , 4 treatment made one session .
-METHODS	In the acupuncture group , acupuncture was applied at Baihui ( GV 20 ) , Fengchi ( GB 20 ) , Jianyu ( LI 15 ) , Quchi ( LI 11 ) , Waiguan ( TE 5 ) , Hegu ( LI 4 ) , Siqiang ( EX-LE 24 ) , Yanglingquan ( GB 34 ) , Zusanli ( ST 36 ) , Fenglong ( ST 40 ) , Qiuxu ( GB 40 ) and Taichong ( LR 3 ) , once every day , 5 times a week , the 4 weeks of treatment made one session .
-METHODS	There was an interval of 1 week between the two sessions in the two groups .
-METHODS	Totally , 2 sessions of treatment were required .
-METHODS	Before and after treatment , the sensory and motor scores , modified barthel index ( MBI ) and blood rheological indices were observed , and the clinical efficacy was evaluated in the patients of the two groups .
-RESULTS	After 8 weeks of treatment , the total effective rate was 90.0 % ( 27/30 ) in the catgut implantation group , which was better than 65.5 % ( 19/29 ) in the acupuncture group ( P < 0.05 ) .
-RESULTS	FugI-Meyer motor function , sensory function scores and MBI were all improved as compared with those before treat ment in the two groups ( all P < 0.05 ) , and the results in the catgut implantation group was superior to the acu puncture group ( all P < 0.05 ) .
-RESULTS	The levels of whole blood viscosity , erythrocyte hematocrit , platelet aggregation and fibrinogen were improved as compared with those before treatment ( all P < 0.05 ) , and the results in the catgut implantation group was better than those in the acupuncture group ( all P < 0.05 ) .
-CONCLUSIONS	The catgut implantation at scalp reflecting foci achieves a satisfactory clinical efficacy on post-stroke sensory disturbance and improves the blood rheological indices .
-
-###25433674
-BACKGROUND	Adherence to the Heart Failure Society of America ( HFSA ) 2010 guidelines recommending 30 minutes of supervised moderate intensity exercise five days per week is difficult for patients with heart failure ( HF ) .
-BACKGROUND	Innovative programs are needed to assist HF patients to adhere to long-term exercise .
-BACKGROUND	The objective of this prospective randomized two-group repeated measures experimental design is to determine the efficacy of a behavioral exercise training intervention on long-term adherence to exercise at 18 months in patients with heart failure .
-METHODS	A sample size of 246 subjects with heart failure will be recruited over a 3 year period .
-METHODS	All subjects receive a cardiopulmonary exercise test and 9 supervised exercise training sessions during a 3 week run-in period prior to randomization .
-METHODS	Subjects completing at least 6 of 9 training sessions are randomized to the HEART Camp Intervention group ( HC ) or to a standard care ( SC ) exercise group .
-METHODS	The HC intervention group receives cognitive-behavioral strategies that address the intervention components of knowledge , attitudes , self-efficacy , behavioral self-management skills and social support .
-METHODS	The SC group is provided access to the exercise facility and regular facility staff for the 18 month study period .
-METHODS	The primary aim is to evaluate the effect of HEART Camp on adherence to exercise , with our central hypothesis that the HC group will have significantly better adherence to exercise at 18 months .
-METHODS	Secondary aims include evaluating which components of the HEART Camp intervention mediate the effects of the intervention on adherence ; evaluating the effect of HEART Camp on specific health outcomes ; exploring selected demographic variables ( race , gender , age ) as potential moderators of the effect of the HEART Camp intervention on adherence ; and exploring the perceptions and experiences that contextualize exercise adherence .
-CONCLUSIONS	The HEART Camp intervention is the first to test a multi-component intervention designed to improve long-term adherence to exercise behavior in patients with HF .
-CONCLUSIONS	Improving long-term adherence to exercise is the logical first step to ensure the required dose of exercise that is necessary to realize beneficial health outcomes and reduce costs in this burdensome chronic illness .
-BACKGROUND	Clincaltrials.gov NCT01658670 .
-
-###25002101
-BACKGROUND	Chronic gastritis ( CG ) , a poorly understood entity , is a very common disease of the digestive tract and is difficult to cure .
-BACKGROUND	Chronic non-atrophic gastritis ( CNG ) is the most common type of CG .
-BACKGROUND	Even if treated with current standard chemotherapy , some patients will not be freed from this confusing disease .
-BACKGROUND	Many studies have shown traditional Chinese medicine ( TCM ) is more effective compared to chemotherapy in the treatment of chronic gastritis and no serious side effects have been identified .
-BACKGROUND	However , the studies that have been carried out were not scientifically rigorous trials .
-BACKGROUND	Our aim is to design a high-quality trial for a new TCM drug , the Jian-Wei-Qu-Tong Pills ( JWQTP ) , to investigate the efficacy and safety of this new drug in treating chronic non-atrophic gastritis patients with spleen and stomach qi deficiency with damp-heat stasis syndrome ( SSQDDSS ) .
-METHODS	This is a phase II , multicenter , parallel-group , double-blind , randomized and placebo-controlled trial .
-METHODS	A total of 240 participants will be assigned to a high-dose group , a low-dose group or a placebo control group with a 1:1:1 ratio at five sites .
-METHODS	Then , one dose ( six 1-g pills ) , with a variable ratio between real drug and dummy drug according to the intervention protocol , will be taken three times a day before each meal for 8 weeks .
-METHODS	The primary outcome is the eradication rate of epigastric pain .
-METHODS	The secondary outcome includes the changes of endoscopic examination , histopathological examination , traditional Chinese medicine symptom scores and patient-reported outcome instrument scores for chronic gastrointestinal diseases and the eradication rate of Helicobacter pylori ( HP ) .
-CONCLUSIONS	Many CNG patients suffer from frequent , recurrent bouts of dyspeptic symptoms .
-CONCLUSIONS	This is the first clinical trial to evaluate the safety and efficacy of JWQTP in treating CNG with SSQDDSS in a multicenter , parallel-group , double-blind , randomized and placebo-controlled manner .
-CONCLUSIONS	This trial may not only provide evidence for a phase III clinical trial , but also a vision of an alternative option for CNG treatment .
-BACKGROUND	The registration number , ChiCTR-TRC-14004088 , was assigned by the Chinese Clinical Trial Registry on 7 January 2014 .
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-###24894533
-OBJECTIVE	To compare the efficacy of tamsulosin versus tamsulosin plus tadalafil as medical expulsive therapy for lower ureteric stones .
-METHODS	Between January 2013 and December 2013 , 244 patients presenting with distal ureteric stones ( size 5-10mm ) were randomized equally to tamsulosin ( group A ) or tamsulosin plus tadalafil ( group B ) .
-METHODS	Therapy was given for a maximum of 4 weeks .
-METHODS	Stone expulsion rate , time to stone expulsion , analgesic use , number of hospital visits for pain , follow up , endoscopic treatment and adverse effects of drugs were recorded .
-METHODS	Statistical analyses were carried out using Student 's t-test and the ( 2 ) - test .
-RESULTS	There was a statistically significant higher expulsion rate in group B compared with group A ( 83.6 % vs 65.5 % ; P-value = 0.031 ) and a shorter time to expulsion ( 14.94.4 days vs 16.74.8 days ; P-value = 0.003 ) .
-RESULTS	Statistically significant differences were noted in terms of the number of hospital visits and analgesic requirement in favor of group B.
-RESULTS	There was no serious adverse event .
-RESULTS	An improvement in erectile function was noted in patients of group B compared with those of group A.
-CONCLUSIONS	Medical expulsive therapy for distal ureteric stones using tamsulosin plus tadalafil is safe , effective and well tolerated .
-CONCLUSIONS	Furthermore , tadalafil provides the additional advantage of improving erectile dysfunction when this condition coexists with a lower ureteric stone .
-
-###25398398
-OBJECTIVE	This prospective randomized study reports the effect of hyaluronan-enriched embryo transfer media on the outcome of in vitro fertilization and embryo transfer ( IVF-ET ) treatments .
-METHODS	A total of 581 IVF-ET cycles were included in this study .
-METHODS	In the Hyaluronan ( HA ) group ( n = 290 ) , embryos were transferred from hyaluronan-enriched transfer medium .
-METHODS	In Control group ( n = 291 ) , a conventional embryo transfer medium was used .
-RESULTS	There was no significant difference in clinical pregnancy rate ( 42.4 vs. 39.2 % ) , implantation rate ( 23.3 vs. 23.2 % ) , and delivery rate ( 31.0 vs. 29.2 % ) between the HA group and the Control group .
-RESULTS	The number of newborns was also similar in the two groups ( 111 vs. 110 ) .
-RESULTS	However , birth weight was significantly higher in the HA group than in the Control group ( 3,018 598 g vs. 2,724 698 g , P = 0.001 ) .
-RESULTS	Clinical pregnancy , implantation and delivery rates did not differ significantly between the HA and the Control group when cycles with advanced maternal age , previous IVF failures , low oocyte number or poor embryo quality were compared .
-CONCLUSIONS	Our results suggest that hyaluronan enrichment of the embryo transfer media does not seem to have any beneficial effect on IVF outcome .
-CONCLUSIONS	However , further study is needed to clarify the role of hyaluronan in the implantation process and on the birth weight .
-
-###25149596
-OBJECTIVE	Ipragliflozin is a novel and highly selective sodium-glucose transporter 2 ( SGLT2 ) inhibitor that reduces plasma glucose levels by enhancing urinary glucose excretion in patients with type 2 diabetes mellitus ( T2DM ) .
-OBJECTIVE	We examined the pharmacokinetic and pharmacodynamic characteristics of two oral doses of ipragliflozin in Japanese patients with T2DM .
-METHODS	In this randomized , placebo-controlled , double-blind study , patients were treated with placebo , 50mg or 100mg ipragliflozin once daily for 14 days .
-METHODS	Plasma and urine pharmacodynamic parameters were measured on Days -1 and 14 , and pharmacokinetic parameters on Day 14 .
-METHODS	Pharmacodynamic characteristics included area under the curve ( AUC ) for plasma glucose and insulin for 0-3h ( AUC0-3h ) and 0-24h ( AUC0-24h ) .
-METHODS	Pharmacokinetic characteristics included AUC0-24h , maximum ipragliflozin concentration ( Cmax ) , and time to maximum plasma ipragliflozin concentration ( tmax ) .
-RESULTS	Thirty patients were enrolled ; 28 were included in pharmacokinetic/pharmacodynamic analyses and 30 in safety analyses .
-RESULTS	Administration of 50 and 100mg ipragliflozin significantly reduced fasting plasma glucose , as well as the AUC0-3h and AUC0-24h for plasma glucose relative to placebo .
-RESULTS	Both doses of ipragliflozin also reduced AUC0-24h for insulin , body weight , and glycoalbumin , while urinary glucose excretion increased remarkably .
-RESULTS	Cmax and AUC0-24h were 1.7 - and 1.9-fold higher , respectively , in the 100-mg group than in the 50-mg group .
-CONCLUSIONS	Ipragliflozin increased urinary glucose excretion and improved fasting and postprandial glucose , confirming its pharmacokinetic/pharmacodynamic properties in Japanese patients with T2DM .
-
-###24266074
-OBJECTIVE	To observe the outcome after sacral canal injection in patients with disc herniation associated with without sciatica .
-METHODS	From December 2010 to June 2011 , 65 patients with acute low back pain without sciatica due to lumbar disc herniation or bulging confirmed by CT or MRI were randomly divided into sacral canal injection group ( experimental group ) and lumbar oblique wrench group ( control group ) : the experimental group had 35 cases , including 30 males and 5 females , with an average age of ( 43.90 + / - 1.14 ) years old ranging from 33 to 56 years old .
-METHODS	The control group had 30 cases , including 27 males and 3 females , with an average age of ( 44.00 + / - 1.19 ) years old ranging from 34 to 57 years old .
-METHODS	The course of morbidity was 1 to 3 days .
-METHODS	All patients received sacral canal injection or lumbar oblique wrench method .
-METHODS	The visual analog scale ( VAS ) scores before and at 30 min after treatment were compared between two groups .
-RESULTS	The symptom of acute low back pain were relieved obviously .
-RESULTS	The average VAS scores before and after treatment in experimental group were decreased from 6.63 + / - 0.97 to 3.06 + / - 1.51 , in control group were from 6.67 + / - 0.96 to 3.93 + / - 1.20 respectively .
-RESULTS	These two methods could improve the VAS score , but the effect of sacral canal injection group was better than that of lumbar oblique wrench group , there was statistically differences ( P < 0.05 ) .
-CONCLUSIONS	It is effective that the methods of sacral canal injection and lumbar oblique wrench applied to patients with acute low back pain without sciatica due to lumbar disc herniation or bulging confirmed , the former has better effect .
-
-###24983748
-OBJECTIVE	Weight loss reduces risk factors associated with obesity .
-OBJECTIVE	However , long-term metabolic improvement remains a challenge .
-OBJECTIVE	We investigated quantitative gene expression of subcutaneous adipose tissue in obese individuals and its relationship with low calorie diet and long term weight maintenance induced changes in insulin resistance .
-METHODS	Three hundred eleven overweight and obese individuals followed a dietary protocol consisting of an 8-week low calorie diet followed by a 6-month ad libitum weight-maintenance diet .
-METHODS	Individuals were clustered according to insulin resistance trajectories assessed using homeostasis model assessment of insulin resistance ( HOMA-IR ) index .
-METHODS	Adipose tissue mRNA levels of 267 genes selected for regulation according to obesity , metabolic status and response to dieting was assessed using high throughput RT-qPCR .
-METHODS	A combination of discriminant analyses was used to identify genes with regulation according to insulin resistance trajectories .
-METHODS	Partial correlation was used to control for change in body mass index .
-RESULTS	Three different HOMA-IR profile groups were determined .
-RESULTS	HOMA-IR improved during low calorie diet in the 3 groups .
-RESULTS	At the end of the 6-month follow-up , groups A and B had reduced HOMA-IR by 50 % .
-RESULTS	In group C , HOMA-IR had returned to baseline values .
-RESULTS	Genes were differentially expressed in the adipose tissue of individuals according to groups but a single gene , CIDEA , was common to all phases of the dietary intervention .
-RESULTS	Changes in adipose tissue CIDEA mRNA levels paralleled variations in insulin sensitivity independently of change in body mass index .
-RESULTS	Overall , CIDEA was up-regulated in adipose tissue of individuals with successful long term insulin resistance relapse and not in adipose tissue of unsuccessful individuals .
-CONCLUSIONS	The concomitant change in adipose tissue CIDEA mRNA levels and insulin sensitivity suggests a beneficial role of adipose tissue CIDEA in long term glucose homeostasis , independently of weight variation .
-BACKGROUND	ClinicalTrials.gov NCT00390637 .
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-###24709364
-BACKGROUND	Despite the increasing complexity of medication regimens for persistent cancer pain , little is known about how oncology outpatients and their family caregivers manage pain medications at home .
-OBJECTIVE	To describe the day-to-day management of pain medications from the perspectives of oncology outpatients and their family caregivers who participated in a randomized clinical trial of a psychoeducational intervention called the Pro-Self ( ) Plus Pain Control Program .
-OBJECTIVE	In this article , we focus on pain medication management in the context of highly individualized home environments and lifestyles .
-METHODS	This qualitative study was conducted as part of a randomized clinical trial , in which an embedded mixed methods research design was used .
-METHODS	Audio-recorded dialogue among patients , family caregivers , and intervention nurses was analyzed using qualitative research methods .
-RESULTS	Home and lifestyle contexts for managing pain medications included highly individualized home environments , work and recreational activities , personal routines , and family characteristics .
-RESULTS	Pain medication management processes particularly relevant in these contexts included understanding , organizing , storing , scheduling , remembering , and taking the medications .
-RESULTS	With the exception of their interactions with the intervention nurses , most study participants had little involvement with clinicians as they worked through these processes .
-CONCLUSIONS	Pain medication management is an ongoing multidimensional process , each step of which has to be mastered by patients and their family caregivers when cancer treatment and supportive care are provided on an outpatient basis .
-CONCLUSIONS	Realistic patient - and family-centered skill-building interventions are needed to achieve effective and safe pain medication management in the contexts of individual home environments and lifestyles .
-
-###24861276
-OBJECTIVE	To assess the comparative drug systemic exposure of a reference ( RF ) and four test ( Test I , Test II , Test III and Test IV ) formulations of triclabendazole ( TCBZ ) in heifers .
-METHODS	Thirty Holstein heifers were randomly distributed into five groups ( n = 6 per group ) .
-METHODS	Animals in the RF group received the reference formulation ( Fasinex ) , and those in the other groups received different commercially available TCBZ formulations ( Test I , Test II , Test III and Test IV ) .
-METHODS	All treatments were orally administered at 12 mg/kg bodyweight .
-METHODS	The concentrations of TCBZ metabolites in plasma between 0 and 168 hours after treatment were quantified by high-performance liquid chromatography ( HPLC ) .
-RESULTS	Triclabendazole sulphoxide ( TCBZ.SO ) and TCBZ-sulphone ( TCBZ.SO ) were the only analytes recovered in plasma .
-RESULTS	Only the Test I formulation did not differ from the RF for all pharmacokinetic parameters measured for either metabolite ( p > 0.8 ) .
-RESULTS	The TCBZ.SO area under the concentration vs. time curve for Test II formulation ( 268.9 g.h / mL ) was lower , and for Test III ( 619.9 g.h / mL ) and Test IV ( 683.4 g.h / mL ) was higher , than the RF ( 418.1 g.h / mL ) ( p < 0.005 ) .
-CONCLUSIONS	Based on the currently available bioequivalence criteria , the only test formulation under evaluation that could be considered equivalent to the RF was the Test I formulation , which demonstrated an equivalent systemic exposure for the active TCBZ.SO metabolite .
-CONCLUSIONS	This comparison of TCBZ pioneer and test formulations in cattle raises awareness of the need for further quality control for drug approval in the veterinary pharmaceutical field in many regions of the world .
-
-###24359036
-OBJECTIVE	The purpose of this pilot study was to conduct limited-efficacy testing of the newly developed Preserving Identity and Planning for Advance Care ( PIPAC ) intervention on self-reported and proxy-reported emotional and health-related outcomes of individuals in the early stages of dementia .
-METHODS	A two-group comparison design was implemented .
-METHODS	Blocked randomization was used to assign individuals with mild dementia and a family contact to either ( 1 ) the four-session , multi-component intervention group focused on reminiscence and future planning or ( 2 ) the minimal support phone contact comparison group .
-METHODS	Of the 19 enrolled dyads , 18completed post-treatment assessments ( i.e. 10 intervention and 8 comparison group ) .
-METHODS	Individuals with dementia were M = 82.8 ( SD = 6.46 ) years old ; 31.6 % were men and 68.4 % were women .
-METHODS	Participants were predominantly white/Caucasian ( n = 18 , 94.7 % ) with one black/African-American ( 5.3 % ) .
-RESULTS	Analyses of covariance controlling for baseline differences revealed clinically meaningful differences ( with medium to large effect sizes ) between groups at post-treatment for depressive symptoms , quality of life , health-related quality of life indicators , and decisional conflict .
-RESULTS	Individuals in the intervention group were also observed to exhibit higher levels of coping .
-RESULTS	Feasibility data collected from participants and interventionists were encouraging .
-CONCLUSIONS	Emotion-focused , patient-centered interventions like PIPAC hold promise for advancing treatment options in the early and mild stages of dementia .
-CONCLUSIONS	A full-scale , randomized clinical trial of this intervention is warranted to determine both short-term and long-term impacts on clinical outcomes including improved depressive symptomatology , quality of life , and health-related factors that impact daily functioning in social environments .
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-###24935294
-BACKGROUND	Currently , there are no published data on pharmacokinetics ( PK ) of everolimus in combination with cyclosporine in Japanese renal transplant patients .
-BACKGROUND	We evaluated the PK of everolimus in Japanese de novo renal transplant patients who received everolimus in combination with cyclosporine .
-METHODS	In this phase 3 , multicenter , randomized , open-label study , patients were randomized ( 1:1 ) to 1 of the 2 groups : everolimus 1.5 mg ( targeted C0 of 3-8 ng/mL ) plus reduced-dose cyclosporine or mycophenolate mofetil 2 g/d plus standard-dose cyclosporine .
-METHODS	PK assessments for everolimus were performed on day 28 ( month 1 ) in the PK subpopulation .
-RESULTS	A total of 11 patients ( 7 men ) , mean age 47.5 11.21 years , were enrolled for PK analysis of everolimus .
-RESULTS	Starting at 1.5 mg ( 0.75 mg twice a day ) , the mean dose over a period of 28 days was 0.705 0.1011 mg .
-RESULTS	Everolimus mean trough concentration was 4.307 1.2459 ng/mL and mean peak concentration was 13.539 3.5330 ng/mL , which peaked at 1 to 2 hours postdose .
-RESULTS	The average concentration was 7.558 1.4723 ng/mL , area under the concentration-time curve was 90.70 17.667 ngh/mL , and peak-trough fluctuation was 122.6 % .
-RESULTS	The PK parameters of everolimus were comparable to those in the earlier phase 3 studies ( A2306 and A2307 ) .
-RESULTS	The mean everolimus trough levels were within the target ranges at all time points ranging from 3.4 to 5.5 ng/mL ( everolimus 0.75 mg twice a day , safety population ) .
-RESULTS	The majority of patients ( > 85 % from day 7 onward ) were maintained within the targeted everolimus trough blood levels ( safety population ) .
-RESULTS	These data were similar to a non-Japanese study ( A2309 ) .
-CONCLUSIONS	The pharmacokinetic characteristics of everolimus in Japanese de novo renal transplant patients did not differ from those previously observed in non-Japanese patients , hence the same dosage of everolimus may be acceptable in Japanese patients .
-
-###25521275
-BACKGROUND	Nerve growth factor ( NGF ) induces profound hyperalgesia .
-BACKGROUND	In this study we explored patterns of NGF sensitization in muscle and fascia of distal and paraspinal sites .
-METHODS	We injected 1 g of NGF into human ( n = 8 ) tibialis anterior and erector spinae muscles and their fasciae .
-METHODS	The spatial extent of pressure sensitization , pressure pain threshold , and mechanical hyperalgesia ( 150 kPa , 10 s ) was assessed at days 0.25 , 1 , 3 , 7 , 14 , and 21 .
-METHODS	Chemical sensitization was explored by acidic buffer injections ( pH 4 , 100 l ) at days 7 and 14 .
-RESULTS	The mechanical hyperalgesia area was larger in tibial fascia than in muscle .
-RESULTS	Pressure pain thresholds were lower , tonic pressure pain ratings , and citrate buffer evoked pain higher in fascia than in muscle .
-CONCLUSIONS	Spatial mechanical sensitization differs between muscle and fascia .
-CONCLUSIONS	Thoracolumbar fasciae appear more sensitive than tibial fasciae and may be major contributors to low back pain , but the temporal sensitization profile is similar between paraspinal and distal sites .
-CONCLUSIONS	Muscle Nerve 52 : 265-272 , 2015 .
-
-###24907224
-BACKGROUND	Pegylated interferon ( peginterferon ) alfa 2a or 2b plus ribavirin regimens were the standard of care in patients with hepatitis C virus ( HCV ) infection , but the sustained virological response can be suboptimum in patients with HCV genotype 1 infection .
-BACKGROUND	The efficacy , safety , and tolerability of the combination of simeprevir , a one-pill , once-daily , oral HCV NS3/4A protease inhibitor versus placebo , plus peginterferon alfa 2a or 2b plus ribavirin was assessed in treatment-naive patients with HCV genotype 1 infection .
-METHODS	In the QUEST-2 , phase 3 study , done at 76 sites in 14 countries ( Europe , and North and South Americas ) , patients with confirmed chronic HCV genotype 1 infection and no history of HCV treatment were randomly assigned with a computer-generated allocation sequence in a ratio of 2:1 and stratified by HCV genotype 1 subtype and host IL28B genotype to receive simeprevir ( 150 mg once daily , orally ) , peginterferon alfa 2a ( 180 g once weekly , subcutaneous injection ) or 2b ( according to bodyweight ; 50 g , 80 g , 100 g , 120 g , or 150 g once weekly , subcutaneous injection ) , plus ribavirin ( 1000-1200 mg/day or 800-1400 mg/day , orally ; simeprevir group ) or placebo ( once daily , orally ) , peginterferon alfa 2a or 2b , plus ribavirin ( placebo group ) for 12 weeks , followed by just peginterferon alfa 2a or 2b plus ribavirin .
-METHODS	Total treatment duration was 24 weeks or 48 weeks ( simeprevir group ) based on criteria for response-guided therapy ( ie , HCV RNA < 25 IU/mL undetectable or detectable at week 4 and undetectable week 12 ) or 48 weeks ( placebo ) .
-METHODS	Patients , study personnel , and the sponsor were masked to treatment assignment .
-METHODS	The primary efficacy endpoint was sustained virological response at 12 weeks after the planned end of treatment ( SVR12 ) .
-METHODS	Analyses were by intention to treat .
-METHODS	The trial is registered with ClinicalTrials.gov , number NCT01290679 .
-METHODS	Results from the primary ( SVR12 , week 60 ) analysis are presented .
-RESULTS	209 ( 81 % ) of 257 patients in the simeprevir group and 67 ( 50 % ) of 134 in the placebo group had SVR12 ( adjusted difference 322 % , 95 % CI 233-412 ; p < 00001 ) .
-RESULTS	The incidences of adverse events were similar in the simeprevir and placebo groups at 12 weeks ( 246 [ 96 % ] vs 130 [ 97 % ] ) and for the entire treatment ( 249 [ 97 % ] vs 132 [ 99 % ] ) , irrespective of the peginterferon alfa used .
-RESULTS	The most common adverse events were headache , fatigue , pyrexia , and influenza-like illness at 12 weeks ( 95 [ 37 % ) vs 45 [ 34 % ] , 89 [ 35 % ] vs 52 [ 39 % ] , 78 [ 30 % ] vs 48 [ 36 % ] , and 66 [ 26 % ] vs 34 [ 25 % ] , respectively ) and for the entire treatment ( 100 [ 39 % ] vs 49 [ 37 % ] , 94 [ 37 % ] vs 56 [ 42 % ] , 79 [ 31 % ] vs 53 [ 40 % ] , and 66 [ 26 % ] vs 35 [ 26 % ] , respectively ) .
-RESULTS	Rash and photosensitivity frequencies were higher in the simeprevir group than in the placebo group ( 61 [ 24 % ] vs 15 [ 11 % ] and ten [ 4 % ] vs one [ < 1 % ] , respectively ) .
-RESULTS	There was no difference in the prevalence of anaemia between the simeprevir and placebo groups ( 35 [ 14 % ] vs 21 [ 16 % ] , respectively , at 12 weeks , and 53 [ 21 % ] vs 37 [ 28 % ] , respectively , during the entire treatment ) .
-CONCLUSIONS	Addition of simeprevir to either peginterferon alfa 2a or peginterferon alfa 2b plus ribavirin improved SVR in treatment-naive patients with HCV genotype 1 infection , without worsening the known adverse events associated with peginterferon alfa plus ribavirin .
-BACKGROUND	Janssen Infectious Diseases-Diagnostics .
-
-###25644342
-BACKGROUND	Bread can contribute to the regulation of appetite .
-OBJECTIVE	The objective of this study was to investigate the appetite ratings and postprandial glucose , insulin , and gastrointestinal hormone responses related to hunger and satiety after the intake of a cereal-based bread .
-METHODS	A randomized , controlled crossover trial was conducted in 30 healthy adults ( 17 men and 13 women ) aged 19-32 y with body mass index of 19.2-28 .5 .
-METHODS	Each volunteer consumed the cereal-based bread and the control bread 2 times , with a 1-wk wash-out period , over a total of 4 sessions .
-METHODS	The cereal-based bread contained a variety of cereal flours ( wheat , oat , and spelt ) and consisted of 22 % dried fruits ( figs , apricots , raisins , and prunes ) .
-METHODS	It was also enriched with both fiber ( 7 % from wheat cross-linked maltodextrins and pea ) and protein ( 10-11 % from wheat gluten and hydrolyzed wheat proteins ) .
-METHODS	The control bread consisted of white bread with margarine and jam to control for energy density , fat , and sugar content .
-METHODS	We measured appetite ratings using standardized visual analogue scales and glucose , insulin , and gastrointestinal hormone responses over a postprandial time of 4 h after the ingestion of each bread .
-METHODS	Linear mixed-effects models were used to compare the areas under the curve ( AUCs ) for different variables .
-RESULTS	Consuming the cereal-based bread decreased prospective consumption more than consumption of the control bread ( -5.3 0.6 m min and -4.4 0.6 m min , respectively ; P = 0.02 ) and increased satiety more ( 6.2 0.7 m min and 5.2 0.6 m min , respectively ; P = 0.04 ) , although subsequent ad libitum energy intake 4 h later did not differ .
-RESULTS	Postprandial blood glucose , insulin , ghrelin , glucagon-like peptide 1 and gastric inhibitory polypeptide AUCs were lower after the ingestion of the cereal-based bread , whereas the pancreatic polypeptide AUC was higher than with the control bread ( P < 0.05 ) .
-CONCLUSIONS	Consumption of the cereal-based bread contributed to appetite control by reducing hunger and enhancing satiety .
-CONCLUSIONS	In addition , consumption of this bread improved glycemic , insulinemic , and gastrointestinal hormone responses in healthy adults .
-CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT02090049 .
-
-###25378034
-OBJECTIVE	The purpose was to assess the effectiveness of 5 % oral glucose solution in reducing pain in preterm infants during intramuscular injection .
-METHODS	We conducted a prospective , randomized , controlled , unblinded trial to investigate the effect of glucose solution on the pain of intramuscular injection in preterm infants ( N = 80 ) .
-RESULTS	Infants who received oral glucose had significantly lower pain scores ( p < .001 ) , less crying time ( p < .001 ) , higher oxygen saturation ( p < .001 ) , and lower heart rate after compared with during the procedure ( p = .02 ) .
-CONCLUSIONS	Our results suggest that oral glucose , even if used in the lowest dose , may have a pain-relieving effect in preterm infants if administered pre-procedure .
-
-###25468945
-OBJECTIVE	There are limited data about the effects of sodium-glucose cotransporter 2 inhibitors when used with insulin .
-OBJECTIVE	We report the efficacy and safety of canagliflozin in patients with type 2 diabetes using insulin .
-METHODS	The CANagliflozin CardioVascular Assessment Study is a double-blind , placebo-controlled study that randomized participants to placebo , canagliflozin 100 mg , or canagliflozin 300 mg once daily , added to a range of therapies .
-METHODS	The primary end point of this substudy was the change in HbA1c from baseline at 18 weeks among patients using insulin ; 52-week effects were also examined .
-RESULTS	Individuals receiving insulin at baseline were randomized to receive placebo ( n = 690 ) , canagliflozin 100 mg ( n = 692 ) , or canagliflozin 300 mg ( n = 690 ) .
-RESULTS	These individuals were 66 % male and had a median age of 63 years , mean HbA1c of 8.3 % ( 67 mmol/mol ) , BMI of 33.1 kg/m ( 2 ) , estimated glomerular filtration rate of 75 mL/min/1 .73 m ( 2 ) , fasting plasma glucose of 9.2 mmol/L , and a median daily insulin dose of 60 IU .
-RESULTS	Most individuals were using basal/bolus insulin .
-RESULTS	Reductions in HbA1c with canagliflozin 100 and 300 mg versus placebo were -0.62 % ( 95 % CI -0.69 , -0.54 ; -6.8 mmol/mol [ 95 % CI -7.5 , -5.9 ] ; P < 0.001 ) and -0.73 % ( 95 % CI -0.81 , -0.65 ; -8.0 mmol/mol [ 95 % CI -8.9 , -7.1 ] ; P < 0.001 ) at 18 weeks and -0.58 % ( 95 % CI -0.68 , -0.48 ; -6.3 mmol/mol [ 95 % CI -7.4 , -5.2 ] ) and -0.73 % ( 95 % CI -0.83 , -0.63 ; -8.0 mmol/mol [ 95 % CI -9.1 , -6.9 ] ) at 52 weeks .
-RESULTS	There were significant falls in fasting plasma glucose , body weight , and blood pressure at both time points and there was a greater incidence of hypoglycemia , genital mycotic infections , and hypovolemia with both canagliflozin doses .
-CONCLUSIONS	Canagliflozin added to insulin therapy improved glycemic control and decreased body weight .
-CONCLUSIONS	There was a greater frequency of several anticipated side effects , although few led to discontinuation of treatment .
-
-###25083010
-OBJECTIVE	To assess the short-term efficacy of a video-based cognitive behavioral therapy for insomnia ( CBT-I ) as compared to a professionally administered CBT-I and to a no-treatment group .
-METHODS	Randomized controlled trial .
-METHODS	Radio-oncology department of a public hospital affiliated with Universit Laval ( CHU de Qubec ) .
-METHODS	Two hundred forty-two women with breast cancer who had received radiation therapy in the past 18 mo and who had insomnia symptoms or were using hypnotic medications were randomized to : ( 1 ) professionally administered CBT-I ( PCBT-I ; n = 81 ) ; ( 2 ) video-based CBT-I ( VCBT-I ; n = 80 ) ; and ( 3 ) no treatment ( CTL ; n = 81 ) .
-METHODS	PCBT-I composed of six weekly , individual sessions of approximately 50 min ; VCBT-I composed of a 60-min animated video + six booklets .
-RESULTS	Insomnia Severity Index ( ISI ) total score and sleep parameters derived from a daily sleep diary and actigraphy , collected at pretreatment and posttreatment .
-RESULTS	PCBT-I and VCBT-I were associated with significantly greater sleep improvements , assessed subjectively , as compared to CTL .
-RESULTS	However , relative to VCBT-I , PCBT-I was associated with significantly greater improvements of insomnia severity , early morning awakenings , depression , fatigue , and dysfunctional beliefs about sleep .
-RESULTS	The remission rates of insomnia ( ISI < 8 ) were significantly greater in PCBT-I as compared to VCBT-I ( 71.3 % versus 44.3 % , P < 0.005 ) .
-CONCLUSIONS	A self-administered cognitive behavioral therapy for insomnia ( CBT-I ) using a video format appears to be a valuable treatment option , but face-to-face sessions remain the optimal format for administering CBT-I efficaciously in patients with breast cancer .
-CONCLUSIONS	Self-help interventions for insomnia may constitute an appropriate entry level as part of a stepped care model .
-BACKGROUND	ClinicalTrials.gov Identifier : NCT00674830 .
-BACKGROUND	Savard J , Ivers H , Savard MH , Morin CM .
-BACKGROUND	Is a video-based cognitive behavioral therapy for insomnia as efficacious as a professionally administered treatment in breast cancer ?
-BACKGROUND	Results of a randomized controlled trial .
-
-###25454968
-OBJECTIVE	To explore the experience of breast cancer patients who either received acupuncture or were allocated to the control group .
-METHODS	Focus group/interviews nested within our multi-site randomised controlled trial .
-METHODS	Participants were recruited from the standard care and experimental arm .
-METHODS	The interviews/focus groups were transcribed and analysed thematically .
-RESULTS	Of the 302 eligible participants 13 % ( n = 40 ) contributed to the focus groups/interviews , across three study sites in the UK .
-RESULTS	Five common themes were identified , including : drivers to take part , the experience of receiving acupuncture , being allocated standard care ( control ) and reflections on taking part in the trial .
-RESULTS	The subgroup of control group participants ( n = 9 ) reported disappointment on hearing their allocation , but recognised the value of their role to the study .
-CONCLUSIONS	Recipients of acupuncture reported beneficial effects in managing fatigue and related symptoms .
-CONCLUSIONS	The finding that control participants were disappointed warrants further investigation and consideration when designing interventional studies .
-
-###24691140
-OBJECTIVE	The aim of this study was to explore the impact of dynamic contrast-enhanced ( DCE ) computer tomography ( CT ) as a biomarker in metastatic renal cell carcinoma ( mRCC ) .
-METHODS	Twelve patients with favorable or intermediate Memorial Sloan Kettering Cancer Center risk group and clear cell mRCC participating in an ongoing prospective randomized phase II trial comprising interleukin-2-based immunotherapy and bevacizumab were included in this preliminary analysis .
-METHODS	All patients had a follow-up time of at least 2 years .
-METHODS	Interpretation of DCE-CT ( max slope method ) was performed blinded to treatment group .
-METHODS	The DCE-CT scans were performed at baseline , at weeks 5 and 10 , and thereafter every third month .
-METHODS	Blood flow ( BF ; mL/min/100 mL ) , peak enhancement ( Hounsfield units ) , time to peak ( seconds ) , and blood volume ( BV ; mL/100 g ) were calculated .
-METHODS	Parameters for DCE-CT were correlated with sum of diameters ( defined by Response Evaluation Criteria in Solid Tumors 1.1 ) , progression-free survival ( PFS ) , and overall survival ( OS ) using Wilcoxon , Man-Whitney , Kaplan-Meier , and log rank statistics , as appropriate .
-RESULTS	Blood flow at baseline ranged from 4.9 to 148.1 mL/min/100 mL ( median , 62.2 ; 25th percentile , 25.8 ; 75th percentile , 110.0 ) .
-RESULTS	Patients with high baseline BF ( using quartiles as cutoffs ) had significantly longer OS ( not reached vs 5.2 months , P = 0.011 ) and longer PFS ( not reached vs 3.9 months , P = 0.026 ) .
-RESULTS	Blood volume at baseline ranged from 8.8 to 74.1 mL/100 g tissue ( median , 21.5 ) , and at week 5 , from 4.9 to 34.7 mL/100 g ( median , 17.2 ) .
-RESULTS	Relative changes in BV between baseline and week 5 ranged from -64 % to +68 % ( median , -16 % ; 25th percentile , -41 % ; 75th percentile , +2 % ) and were significantly associated with OS using quartiles as cutoffs ( 5.2 months vs not reached , P = 0.038 ) and PFS using the median as cutoff ( 5.3 months vs not reached , P = 0.009 ) , with larger reductions associated with longer survival .
-RESULTS	Using medians as cutoffs , relative changes in both BF and BV between baseline and week 10 were significantly associated with OS ( for both , 8.6 months vs not reached , P = 0.031 ) .
-CONCLUSIONS	Dynamic contrast-enhanced CT is a potential biomarker in patients with mRCC .
-CONCLUSIONS	High baseline BF and reductions in BF and BV during early treatment are associated with improved outcome .
-CONCLUSIONS	Large-scale studies are required .
-
-###24752284
-OBJECTIVE	The aims of this study were to ( i ) evaluate the efficacy of phoneme discrimination training for hearing and cognitive abilities of adults aged 50 to 74 years with mild sensorineural hearing loss who were not users of hearing aids , and to ( ii ) determine participant compliance with a self-administered , computer-delivered , home - and game-based auditory training program .
-METHODS	This study was a randomized controlled trial with repeated measures and crossover design .
-METHODS	Participants were trained and tested over an 8 - to 12-week period .
-METHODS	One group ( Immediate Training ) trained during weeks 1 and 4 .
-METHODS	A second waitlist group ( Delayed Training ) did no training during weeks 1 and 4 , but then trained during weeks 5 and 8 .
-METHODS	On-task ( phoneme discrimination ) and transferable outcome measures ( speech perception , cognition , self-report of hearing disability ) for both groups were obtained during weeks 0 , 4 , and 8 , and for the Delayed Training group only at week 12 .
-RESULTS	Robust phoneme discrimination learning was found for both groups , with the largest improvements in threshold shown for those with the poorest initial thresholds .
-RESULTS	Between weeks 1 and 4 , the Immediate Training group showed moderate , significant improvements on self-report of hearing disability , divided attention , and working memory , specifically for conditions or situations that were more complex and therefore more challenging .
-RESULTS	Training did not result in consistent improvements in speech perception in noise .
-RESULTS	There was no evidence of any test-retest effects between weeks 1 and 4 for the Delayed Training group .
-RESULTS	Retention of benefit at 4 weeks post-training was shown for phoneme discrimination , divided attention , working memory , and self-report of hearing disability .
-RESULTS	Improved divided attention and reduced self-reported hearing difficulties were highly correlated .
-CONCLUSIONS	It was observed that phoneme discrimination training benefits some but not all people with mild hearing loss .
-CONCLUSIONS	Evidence presented here , together with that of other studies that used different training stimuli , suggests that auditory training may facilitate cognitive skills that index executive function and the self-perception of hearing difficulty in challenging situations .
-CONCLUSIONS	The development of cognitive skills may be more important than the development of sensory skills for improving communication and speech perception in everyday life .
-CONCLUSIONS	However , improvements were modest .
-CONCLUSIONS	Outcome measures need to be appropriately challenging to be sensitive to the effects of the relatively small amount of training performed .
-
-###24612764
-OBJECTIVE	Expiratory asynchrony during pressure support ventilation ( PSV ) has been recognized as a cause of patient discomfort , increased workload , and impaired weaning process .
-OBJECTIVE	We evaluated breathing pattern , patient comfort , and patient effort during PSV comparing 2 flow termination criteria : fixed at 5 % of peak inspiratory flow vs automatic , real-time , breath-by-breath adjustment within the range of 5 % to 55 % .
-METHODS	Randomized crossover clinical trial .
-METHODS	Sixteen awake patients , in the process of weaning , under PSV for more than 24 hours were subjected to 3 phases of PSV , each lasting 1 hour and using 1 of the 2 aforementioned termination criteria .
-RESULTS	Effective pressure support during automatic adjustment ( AA ) was 12.53.2 cm H2O vs 12.53.9 cm H2O ( P = .9 ) with the fixed termination criterion , and external positive end-expiratory pressure was 6.21.8 vs 6.82 ( P < .05 ) .
-RESULTS	The effective termination criterion was higher during AA ( 31 % [ 23-39 ] vs 12 % [ 6-23 ] ; P < .01 ) , but without producing premature breath terminations .
-RESULTS	Pressure overshoots and alternative cycling-off were also decreased .
-RESULTS	Throughout the AA period , we observed a higher respiratory rate ( 248 breaths/min vs 196 breaths/min ; P < .001 ) , lower tidal volume ( 484 88 mL vs 518102 mL ; P < .001 ) , and shorter inspiratory times ( 1.00.3 seconds vs 1.30.3 seconds ; P < .001 ) .
-RESULTS	Automatic adjustment was associated with lower airway occlusion pressure after 0.1 second ( P0 .1 ) ( 1.80.9 cm H2O vs 2.41 cm H2O ; P < .01 ) , lower pressure-time product to trigger the ventilator , and lower subjective discomfort ( visual analog scale , 3.71.3 vs 4.51.2 ; P < .001 ) .
-CONCLUSIONS	When compared with a fixed termination criterion , the use of a variable , real-time-adjusted termination criterion improved some indices of patient-ventilator synchrony , producing better breathing pattern , less discomfort , and slightly lower patient effort during PSV .
-
-###25268968
-BACKGROUND	Several studies have suggested that cognitive training is a potentially effective way to improve cognition and postpone cognitive decline in older adults with mild cognitive impairment ( MCI ) .
-BACKGROUND	The MEMO + study is a randomized , controlled , single-blind trial designed to test the efficacy , specificity , and long-term effect of a cognitive training intervention and a psychosocial intervention in persons with MCI .
-METHODS	One hundred and sixty-two participants with MCI will be recruited .
-METHODS	They will be randomized into three groups : cognitive training , psychosocial intervention , and no-contact .
-METHODS	Each intervention will last for eight weeks ( one session per week ) and a booster training session will be provided three months after the end of the intervention .
-METHODS	Various proximal and distal outcomes will be measured at pre-intervention as well as at one week , three months , and six months post-training .
-METHODS	Proximal outcomes include memory and psychological health measures .
-METHODS	Distal outcomes focus on self-rated functioning in complex daily activities and strategies used in daily life to enhance function .
-METHODS	Socio-demographic factors ( age , gender , and education ) , general cognition , personality traits , engagement in activities , and self-efficacy will be used as moderators .
-METHODS	Enrolment began in April 2012 and will be completed by December 2014 .
-CONCLUSIONS	This study is likely to have a significant impact on the well-being of persons with MCI by contributing to the development of adapted and scientifically supported cognitive and psychosocial interventions .
-
-###25581505
-OBJECTIVE	To identify risk factors for early study termination and motivators for adherence to a long-term followup trial and to improve completeness of long-term studies .
-METHODS	Risk factors for early termination in 508 included patients were identified through Cox regression analysis .
-METHODS	Patients completing the 10-year followup filled in a questionnaire on possible motives for continued study participation .
-RESULTS	Risk factors for early termination were higher age ( hazard ratio [ HR ] 1.03 , 95 % confidence interval [ 95 % CI ] 1.02-1 .04 ) , functional disability during the preceding year ( HR 1.54 , 95 % CI 1.20-1 .99 ) , having achieved drug-free remission ( HR 6.62 , 95 % CI 2.07-21 .14 ) , limited joint damage ( HR 0.98 , 95 % CI 0.97-0 .995 for actual damage ; HR 0.83 , 95 % CI 0.73-0 .94 for damage progression ) , and few adverse events ( HR 0.35 , 95 % CI 0.26-0 .47 ) .
-RESULTS	A total of 288 of 313 patients ( 92 % ) attending the last visit answered the questionnaire .
-RESULTS	The majority mentioned contributing to scientific research ( 97 % agreed ) , helping other patients ( 91 % ) , and learning about new treatment strategies ( 84 % ) and their disease ( 85 % ) as reasons to continue participation .
-RESULTS	Next , patients mentioned tight control ( 202 of 278 patients ) , good treatment strategy ( 128 of 278 ) , good medication ( 117 of 278 ) , and good half-term results ( 102 of 278 ) as motivators .
-RESULTS	More than 95 % of patients experienced participation `` as expected '' or `` better than expected . ''
-RESULTS	Additional examinations during yearly visits ( extra questionnaires , imaging ) were mentioned as `` worse than expected '' ( 10 % ) , as was answering routine questionnaires ( 7 % ) .
-CONCLUSIONS	Continued participation was relatively high in the Treatment Strategies for Rheumatoid Arthritis ( BeSt ) Study .
-CONCLUSIONS	Higher age , functional disability , drug-free remission , little joint damage , and few adverse events predicted early study termination .
-CONCLUSIONS	Main motives for continued participation were a willingness to contribute to research , help future patients , and because patients had good experiences with the study protocol .
-
-###25320199
-BACKGROUND	The surgical results of treating thoracolumbar and lumbar burst fractures were reported to be comparable between patients with and without fusion in an intermediate-term follow-up .
-BACKGROUND	To our knowledge , no prior report has compared the results of fusion and non-fusion with long-term follow-up .
-METHODS	This study was designed to provide long-term evaluation of patients with a burst fracture of the thoracolumbar and lumbar spine treated with short-segment fixation who were randomly assigned to a fusion or non-fusion group .
-METHODS	Patients older than sixty years of age at the time of injury and those who were lost to follow-up were excluded .
-METHODS	Functional outcomes were evaluated using the Greenough Low-Back Outcome Score and the visual analog scale for back pain .
-METHODS	Radiographic outcomes were focused on the vertebral body height of the injured vertebra , the kyphotic angle , and the regional segmental motion .
-RESULTS	Twenty-two patients were enrolled in the non-fusion group , and twenty-four patients were enrolled in the fusion group .
-RESULTS	The average follow-up period was 134 months ( range , 121 to 161 months ) .
-RESULTS	The average preoperative kyphotic angle was 16.4 for the non-fusion group and 19.5 for the fusion group .
-RESULTS	The average postoperative kyphotic angle was 1.5 for the non-fusion group and 4.0 for the fusion group .
-RESULTS	At the time of the latest follow-up , the average kyphotic angle was 13.8 for the non-fusion group and 14.7 for the fusion group .
-RESULTS	The average kyphotic angle between the two groups was similar at all follow-up times .
-RESULTS	A progressive decrease of the kyphotic angle was significant ( p < 0.05 ) with time , regardless of fusion .
-RESULTS	The radiographic outcomes were similar between these two groups at all follow-up times , as were functional outcomes .
-RESULTS	More patients in the non-fusion group underwent additional surgery to remove implants .
-RESULTS	Regional segmental motion was preserved in the non-fusion group , with a mean motion ( and standard deviation ) of 4.2 1.9 .
-CONCLUSIONS	The long-term results of short segmental fixation with and without fusion for burst fractures of the thoracolumbar and lumbar spine were comparable .
-CONCLUSIONS	Regional segmental motion could be preserved without fusion , and bone graft donor site complications could be eliminated .
-METHODS	Therapeutic Level II .
-METHODS	See Instructions for Authors for a complete description of levels of evidence .
-
-###24716775
-BACKGROUND	Little is known about the reliability of different methods of survey administration in low back pain trials .
-BACKGROUND	This analysis was designed to determine the reliability of responses to self-administered paper surveys compared to computer assisted telephone interviews ( CATI ) for the primary outcomes of pain intensity and back-related function , and secondary outcomes of patient satisfaction , SF-36 , and global improvement among participants enrolled in a study of yoga for chronic low back pain .
-RESULTS	Pain intensity , back-related function , and both physical and mental health components of the SF-36 showed excellent reliability at all three time points ; ICC scores ranged from 0.82 to 0.98 .
-RESULTS	Pain medication use showed good reliability ; kappa statistics ranged from 0.68 to 0.78 .
-RESULTS	Patient satisfaction had moderate to excellent reliability ; ICC scores ranged from 0.40 to 0.86 .
-RESULTS	Global improvement showed poor reliability at 6weeks ( ICC = 0.24 ) and 12weeks ( ICC = 0.10 ) .
-CONCLUSIONS	CATI shows excellent reliability for primary outcomes and at least some secondary outcomes when compared to self-administered paper surveys in a low back pain yoga trial .
-CONCLUSIONS	Having two reliable options for data collection may be helpful to increase response rates for core outcomes in back pain trials .
-BACKGROUND	ClinicalTrials.gov : NCT01761617 .
-BACKGROUND	Date of trial registration : December 4 , 2012 .
-
-###25308883
-OBJECTIVE	To evaluate the efficacy of manual lymphatic drainage ( MLD ) in improving health-related quality of life ( HRQOL ) , symptomatology , and physical status in patients with chronic venous insufficiency ( CVI ) .
-METHODS	Single-blind randomized controlled trial .
-METHODS	Health community attendant service .
-METHODS	Subjects with CVI ( N = 41 ) were randomly assigned to an experimental group ( n = 20 ; mean age , 54.611.3 y ) or control group ( n = 21 ; mean age , 46.811.1 y ) .
-METHODS	The experimental group completed 10 lower extremity MLD sessions over 4 weeks and 1 educational session .
-METHODS	The control group only attended the educational session .
-METHODS	Outcome measures were taken at baseline ( t0 ) , at the end of 4 weeks ( t1 ) , and after 2 months for follow-up ( t2 ) .
-METHODS	HRQOL was assessed with the Chronic Venous Insufficiency Quality of Life Questionnaire-20 , symptoms ( fatigue , heaviness ) were assessed with a visual analog scale , severity of the disease was assessed with the Venous Clinical Severity Score ( VCSS ) ( total score , score for each item ) , leg volumetry was assessed with perimeters , and plantar/dorsiflexion strength and ankle range of motion ( ROM ) were assessed with dynamometry .
-RESULTS	A significant interaction grouptime effect was found for pain on HRQOL ( F2 ,78 = 3.507 ; P = .035 ; partial 2 = .087 ) , clinical severity ( F2 ,78 = 5.231 ; P = .007 ; partial 2 = .118 ) , especially for venous edema ( assessed with the VCSS ) , fatigue ( F1 .67,65.21 = 4.690 ; P = .012 ; partial 2 = .107 ) , and heaviness ( F1 .57,61.32 = 9.702 ; P = .001 ; partial 2 = .199 ) , with the experimental group improving from t0 to t1 and t0 to t2 in all of these outcomes .
-RESULTS	No effect of MLD treatment could be found for ankle muscle strength , ankle ROM , and leg volume .
-CONCLUSIONS	Short-term MLD treatment ameliorates CVI severity and related edema , symptoms , and pain HRQOL in patients with CVI .
-
-###24582273
-BACKGROUND	Identifying patients with recent stroke or transient ischemic attack ( TIA ) at high risk of major vascular events ( MVEs ; stroke , myocardial infarction , or vascular death ) may help optimize the intensity of secondary preventive interventions .
-BACKGROUND	We evaluated the relationships between the baseline Framingham Coronary Risk Score ( FCRS ) and a novel risk prediction model and with the occurrence of MVEs after stroke or TIA in subjects enrolled in the Stroke Prevention by Aggressive Reduction in Cholesterol Level ( SPARCL ) trial .
-METHODS	Data from the 4731 subjects enrolled in the SPARCL study were analyzed .
-METHODS	Hazard ratios ( HRs ) from Cox regression models were used to determine the risk of subsequent MVEs based on the FCRS predicting 20 % or more 10-year coronary heart disease risk .
-METHODS	The novel risk model was derived based on multivariable modeling with backward selection .
-METHODS	Model discrimination ( c-statistics ) was assessed using the areas under the receiver operating characteristic curves .
-RESULTS	Of 3969 subjects with complete data , 27 % had a baseline FCRS of 20 % or more .
-RESULTS	In multivariable analysis , an FCRS of 20 % or more was associated with twice the risk of subsequent MVEs ( HR = 1.92 , 95 % confidence interval [ CI ] : 1.63-2 .27 ) .
-RESULTS	The novel model based on a multivariable analysis included age ( HR = 1.37 , 95 % CI : 1.25-1 .51 per 10 years ) , diabetes ( HR = 1.82 , 95 % CI : 1.51-2 .18 ) , male sex ( HR = 1.35 , 95 % CI : 1.12-1 .61 ) , and an apolipoprotein ( APO ) - B/APO-A 1 ratio ( HR = 1.56 , 95 % CI : 1.16-2 .11 ) .
-RESULTS	The c-statistic was .58 ( 95 % CI : .55 -.60 ) for the FCRS of 20 % or more and .65 ( 95 % CI : .63 -.67 ) for the novel model .
-CONCLUSIONS	Both a baseline FCRS of 20 % or more and a novel predictive model were associated with future MVEs in SPARCL trial subjects .
-CONCLUSIONS	The novel model needs to be validated , and the benefits of using either the FCRS or the novel model in clinical practice needs to be assessed .
-
-###26218727
-BACKGROUND	Juvderm Voluma XC ( VYC-20L ) is approved in the United States for correction of age-related volume loss in the midface region in adults .
-OBJECTIVE	To characterize the effects of VYC-20L in 3 midface subregions based on injection volumes .
-METHODS	In this single-blind controlled trial , subjects with midface volume deficit received VYC-20L in 1 of 3 facial subregions ( zygomaticomalar , anteromedial cheek , and submalar ) , with touch-up treatment available 30 days later .
-METHODS	Responders achieved 1-point improvement on the Mid-Face Volume Deficit Scale ( MFVDS ) , analyzed by facial subregion and stratified by injection volume quartiles .
-METHODS	Subject satisfaction and safety were assessed .
-RESULTS	The treatment arm comprised 235 subjects aged 35 to 65 years .
-RESULTS	Month 6 MFVDS responder rates were 75.5 % for zygomaticomalar , 83.2 % for anteromedial cheek , and 76.9 % for submalar subregions .
-RESULTS	Higher responder rates were observed with increasing injection volume quartiles for each subregion .
-RESULTS	Similar median injection volumes ( 2.0 mL total ) of VYC-20L provided correction durations of 15 to 24 months : 24 months for anteromedial cheek , 19 months for zygomaticomalar , and 15 months for submalar subregions .
-RESULTS	Subject satisfaction was high across injection volume quartiles .
-RESULTS	No unanticipated treatment-site adverse reactions occurred .
-CONCLUSIONS	VYC-20L is effective at restoring midface volume , with high subject satisfaction and an acceptable safety profile .
-
-###24418351
-OBJECTIVE	Intensive lifestyle change prevents type 2 diabetes but is difficult to sustain .
-OBJECTIVE	Preliminary evidence suggests that yoga may improve metabolic factors .
-OBJECTIVE	We tested a restorative yoga intervention vs. active stretching for metabolic outcomes .
-METHODS	In 2009-2012 , we conducted a 48-week randomized trial comparing restorative yoga vs. stretching among underactive adults with the metabolic syndrome at the Universities of California , San Francisco and San Diego .
-METHODS	We provided lifestyle counseling and a tapering series of 90-min group classes in the 24-week intervention period and 24-week maintenance period .
-METHODS	Fasting and 2-h glucose , HbA1c , triglycerides , HDL-cholesterol , insulin , systolic blood pressure , visceral fat , and quality of life were assessed at baseline , 6 - and 12-months .
-RESULTS	180 participants were randomized and 135 ( 75 % ) completed the trial .
-RESULTS	At 12 months , fasting glucose decreased more in the yoga group than in the stretching group ( -0.35 mmol/L vs. -0.03 mmol/L ; p = 0.002 ) ; there were no other significant differences between groups .
-RESULTS	At 6 months favorable changes within the yoga group included reductions in fasting glucose , insulin , and HbA1c and an increase in HDL-cholesterol that were not sustained at 1 year except changes in fasting glucose .
-RESULTS	The stretching group had a significant reduction in triglycerides at 6 months which was not sustained at 1 year but had improved quality of life at both time-points .
-CONCLUSIONS	Restorative yoga was marginally better than stretching for improving fasting glucose but not other metabolic factors .
-
-###25391047
-OBJECTIVE	While the Carotid Revascularization Endarterectomy Versus Stenting Trial ( CREST ) has been widely accepted as a landmark trial establishing an equivalent risk of major adverse events following carotid endarterectomy ( CEA ) or carotid artery stenting ( CAS ) , the applicability of these findings to single centers has been questioned owing to the rigid selection criteria for investigators in the study .
-OBJECTIVE	Although refuted by the findings of a subsequent study , a substudy of CREST established a higher periprocedural stroke rate for CAS when the surgeon was a vascular surgeon .
-OBJECTIVE	To present our 30-day results of stroke , death , myocardial infarction , and composite major adverse events to determine if a single vascular surgeon 's outcomes at our hospital are consistent with the results of CREST .
-METHODS	A retrospective analysis of patients with high-grade carotid artery stenosis treated with CEA or CAS by a vascular surgeon at our institution from September 9 , 2005 , through December 17 , 2012 , was performed .
-METHODS	A 2 analysis was used to compare the incidence of specific high-risk patient characteristics in each group .
-METHODS	The Fisher exact test was used to compare the risks of stroke , death , myocardial infarction , and composite major adverse events between CEA and CAS .
-METHODS	These results were then compared with those reported in CREST .
-RESULTS	A total of 182 cases ( 94 CAS and 88 CEA ) performed by a single vascular surgeon were included for analysis .
-RESULTS	While in CREST the periprocedural risk of stroke was higher following CAS ( 4.1 % vs 2.3 % , P = .01 ) and the risk of myocardial infarction was higher following CEA ( 2.3 % vs 1.1 % , P = .03 ) , there was no significant difference in the incidence of these outcomes between the 2 treatment modalities in our study .
-RESULTS	When compared with CREST , our rates of myocardial infarction , stroke , death , and composite adverse events ( CEA , 4.5 % vs 3.4 % ; P = .79 ; CAS , 5.2 % vs 4.3 % ; P > .99 ) were no different .
-CONCLUSIONS	Similar to CREST , the 30-day risk of composite major adverse events was equivalent for the 2 treatment modalities .
-CONCLUSIONS	We attribute our comparable incidence of perioperative stroke with CAS and CEA to improved patient selection .
-CONCLUSIONS	We excluded most patients older than 80 years and those with complex anatomy from consideration for CAS .
-CONCLUSIONS	Our results confirm those of CREST and demonstrate that both CEA and CAS can be performed safely by a vascular surgeon in properly selected patients .
-
-###24337423
-BACKGROUND	The efficacy of functional restoration programs for the treatment of chronic back pain is well documented .
-BACKGROUND	Nevertheless , there are only a few such centres in Germany and few trials have been conducted in German-speaking regions to demonstrate that implementing such programs in everyday clinical settings with large numbers of patients is just as effective as in a research setting .
-BACKGROUND	The present study examined whether the positive effects of such programs can also be observed in the clinically relevant context of a standardized day clinic treatment regimen .
-METHODS	A total of 681 back pain patients in 2 German cities were examined at 4 measurement points ( before and immediately after the program , as well as 6 and 12 months after treatment ) using a comprehensive questionnaire on perceived pain and symptoms of anxiety and depression , as well as the work situation .
-RESULTS	In both cities significant and long-term improvements in back pain , pain-related impairment and degree of chronification were observed , as well as a high return-to-work rate after treatment .
-RESULTS	Hence , the quality of such programs was also confirmed for a large patient population .
-
-###25112865
-OBJECTIVE	We conducted a 6-month , randomized , double-blind , placebo-controlled study to assess safety , tolerability , and efficacy of deferiprone in Friedreich ataxia ( FRDA ) .
-METHODS	Seventy-two patients were treated with deferiprone 20 , 40 , or 60mg/kg/day or placebo , divided into 2 daily doses .
-METHODS	Safety was the primary objective ; secondary objectives included standardized neurological assessments ( Friedreich Ataxia Rating Scale [ FARS ] , International Cooperative Ataxia Rating Scale [ ICARS ] , 9-Hole Peg Test [ 9HPT ] , Timed 25-Foot Walk , Low-Contrast Letter Acuity ) , general functional status ( Activities of Daily Living ) , and cardiac assessments .
-RESULTS	Deferiprone was well tolerated at 20mg/kg/day , whereas more adverse events occurred in the 40mg/kg/day than in the placebo group .
-RESULTS	The 60mg/kg/day dose was discontinued due to worsening of ataxia in 2 patients .
-RESULTS	One patient on deferiprone 20mg/kg/day experienced reversible neutropenia , but none developed agranulocytosis .
-RESULTS	Deferiprone-treated patients receiving 20 or 40mg/kg/day showed a decline in the left ventricular mass index , compared to an increase in the placebo-treated patients .
-RESULTS	Patients receiving 20mg/kg/day of deferiprone had no significant change in FARS , similar to the placebo-treated patients , whereas those receiving 40mg/kg/day had worsening in FARS and ICARS scores .
-RESULTS	The lack of deterioration in the placebo arm impaired the ability to detect any potential protective effect of deferiprone .
-RESULTS	However , subgroup analyses in patients with less severe disease suggested a benefit of deferiprone 20mg/kg/day on ICARS , FARS , kinetic function , and 9HPT .
-CONCLUSIONS	This study demonstrated an acceptable safety profile of deferiprone at 20mg/kg/day for the treatment of patients with FRDA .
-CONCLUSIONS	Subgroup analyses raise the possibility that , in patients with less severe disease , deferiprone 20mg/kg/day may reduce disease progression , whereas higher doses appear to worsen ataxia .
-
-###24317232
-OBJECTIVE	We describe a new approach to blocking the sciatic and saphenous nerves in the proximal thigh ( level of the lesser trochanter or immediately below ) using a single-penetration dual-injection ( SPEDI ) technique .
-OBJECTIVE	The popliteal-sciatic approach necessitates repositioning of the leg exposing the popliteal fossa and an extra injection for the saphenous nerve ( SAN ) block at the midthigh level .
-OBJECTIVE	We introduce an alternative , effective , and possibly faster method .
-METHODS	Sixty patients undergoing leg and foot surgery under general anesthesia were included .
-METHODS	We deposited 15 mL of ropivacaine 0.75 % around the sciatic nerve ( SCN ) and 5 mL of ropivacaine 0.75 % at the SAN .
-METHODS	Patients were randomized to the popliteal-sciatic/saphenous technique or the SPEDI technique .
-METHODS	The primary outcome measure was performance time .
-METHODS	Positioning time , pain assessment , nausea in the postanesthesia care unit , sufentanil demand , dermatomal anesthesia , and degree of motor blockade were also recorded .
-RESULTS	Performance time was significantly faster with the SPEDI technique ( median time , 110 seconds [ range , 57-315 seconds ] vs 246 seconds [ range , 163-472 seconds ] ; P < 0.0001 ) .
-RESULTS	Positioning time was significantly shorter with the SPEDI technique ( P < 0.0001 ) .
-RESULTS	No other statistically significant differences were recorded .
-CONCLUSIONS	The SPEDI block resulted in significantly faster performance time and reduced positioning time with statistically equal efficacy in relation to pain assessment , nausea , sufentanil demand , dermatomal anesthesia , and motor blockade .
-CONCLUSIONS	The SPEDI block is statistically an equally effective alternative to the traditional popliteal-sciatic/saphenous block combination for leg and foot surgery , but it is faster , requires only 1 skin penetration , and does not require repositioning of the leg .
-
-###25397864
-BACKGROUND	Near-infrared ( NIR ) light therapy is purported to act as an ergogenic aid by enhancing the contractile function of skeletal muscle .
-BACKGROUND	Improving muscle function is a new avenue for research in the area of laser therapy ; however , very few researchers have examined the ergogenic effects of NIR light therapy and the influence it may have on the recovery process during rehabilitation .
-OBJECTIVE	To evaluate the ergogenic effect of NIR light therapy on skeletal muscle function .
-METHODS	Crossover study .
-METHODS	Controlled laboratory .
-METHODS	Thirty-nine healthy men ( n = 21 ) and women ( n = 18 ; age = 20.0 0.2 years , height = 169 2 cm , mass = 68.4 1.8 kg , body mass index = 23.8 0.4 kg/m ( 2 ) ) .
-METHODS	Each participant received active and sham treatments on the biceps brachii muscle on 2 separate days .
-METHODS	The order of treatment was randomized .
-METHODS	A class 4 laser with a cumulative dose of 360 J was used for the active treatment .
-METHODS	After receiving the treatment on each day , participants completed an elbow-flexion resistance-exercise protocol .
-METHODS	The dependent variables were elbow range of motion , muscle point tenderness , and strength ( peak torque ) .
-METHODS	Analysis of variance with repeated measures was used to assess changes in these measures between treatments at baseline and at follow-up , 48 hours postexercise .
-METHODS	Additionally , immediate strength loss postexercise was compared between treatments using a paired t test .
-RESULTS	Preexercise to postexercise strength loss for the active laser treatment , although small , was less than with the sham treatment ( P = .05 ) .
-CONCLUSIONS	Applied to skeletal muscle before resistance exercise , NIR light therapy effectively attenuated strength loss .
-CONCLUSIONS	Therefore , NIR light therapy may be a beneficial , noninvasive modality for improving muscle function during rehabilitation after musculoskeletal injury .
-CONCLUSIONS	However , future studies using higher treatment doses are warranted .
-
-###25833970
-BACKGROUND	Efficient fat digestion requires fat processing within the stomach and fat sensing in the intestine .
-BACKGROUND	Both processes also control gastric emptying and gastrointestinal secretions .
-OBJECTIVE	We aimed to visualize the influence of the intragastric stability of fat emulsions on their dynamics of gastric processing and structuring and to assess the effect this has on gastrointestinal motor and secretory functions .
-METHODS	Eighteen healthy subjects with normal body mass index ( BMI ) were studied on 4 separate occasions in a double-blind , randomized , crossover design .
-METHODS	Magnetic resonance imaging ( MRI ) data of the gastrointestinal tract and blood triglycerides were recorded before and for 240 min after the consumption of the following 4 different fat emulsions : lipid emulsion 1 ( LE1 ; acid stable , 0.33 m ) , lipid emulsion 2 ( LE2 ; acid stable , 52 m ) , lipid emulsion 3 ( LE3 ; acid unstable , solid fat , 0.32 m ) , and lipid emulsion 4 ( LE4 ; acid unstable , liquid fat , 0.38 m ) .
-RESULTS	Intragastric emulsion instability was associated with a change in gastric emptying .
-RESULTS	Acid-unstable emulsions exhibited biphasic and faster emptying profiles than did the 2 acid-stable emulsions ( P 0.0001 ) .
-RESULTS	When combined with solid fat ( LE3 ) , different dynamics of postprandial gallbladder volume were induced ( P 0.001 ) .
-RESULTS	For acid-stable emulsions , a reduction of droplet size by 2 orders of magnitude [ LE1 ( 0.33 m ) compared with LE2 ( 52 m ) ] delayed gastric emptying by 38 min .
-RESULTS	Although acid-stable ( LE1 and LE2 ) and redispersible ( LE4 ) emulsions caused a constant increase in blood triglycerides , no increase was detectable for LE3 ( P < 0.0001 ) .
-RESULTS	For LE3 , MRI confirmed the generation of large fat particles during gastric processing , which emptied into and progressed through the small intestine .
-CONCLUSIONS	MRI allows the detailed characterization of the in vivo fate of lipid emulsions .
-CONCLUSIONS	The acute effects of lipid emulsions on gastric emptying , gallbladder volume , and triglyceride absorption are dependent on microstructural changes undergone during consumption .
-CONCLUSIONS	Gastric peristalsis and secretion were effective at redispersing pools of liquid fat in the stomach .
-CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01253005 .
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-###24535356
-OBJECTIVE	To explore a new method of patient-involved digital design , esthetic outcome prediction and fabrication for the esthetic rehabilitation of anterior teeth , and to provide an alternative choice for the restoration of anterior teeth .
-METHODS	In this study , 32 patients with esthetic problems in their anterior teeth were included and divided into two groups randomly : the experimental group ( 16 patients ) and control group ( 16 patients ) .
-METHODS	In the experimental group , the dentition and facial images were obtained by intra-oral scanning and Three-dimensional ( 3D ) facial scanning and then calibrated .
-METHODS	The design of the rehabilitation and the esthetic outcome prediction were created by computer-aided design ( CAD ) software .
-METHODS	After morphologic modification according to the patients ' opinions , prostheses were fabricated according to the final design by computer-aided manufacturing ( CAM ) equipment .
-METHODS	As for the control group , the regular design method was applied to restore their anterior teeth .
-METHODS	The time consuming in the first insertion of each restoration in both groups was recorded .
-METHODS	The quality of the prostheses was assessed by another prosthedontist .
-METHODS	The satisfaction to prostheses and the facial appearance were evaluated by the patients .
-RESULTS	The process of the patient-involved digital design and outcome anticipation was successfully established .
-RESULTS	The patients were satisfied with the esthetic effects of the anterior restoration made by the digital technique .
-RESULTS	The acceptance rate of the patients on the digital rehabilitation in the experimental group was 100 % .
-RESULTS	There was no significant difference of the quality of the prostheses between the two groups .
-RESULTS	The satisfaction rate of the patients on prostheses and facial appearance was significantly higher in the experimental group than in the control group ( P < 0.05 ) .
-RESULTS	In addition , the time consuming in the first insertion of the experimental group was much shorter than that in the control group ( P < 0.01 ) .
-CONCLUSIONS	The new method of the patient-involved digital design , esthetic outcome prediction and fabrication for the esthetic rehabilitation of anterior teeth is a practical technique .
-CONCLUSIONS	This method is useful in shortening the time consuming of the restoration of anterior teeth and improving the patient satisfaction with the esthetic outcome .
-
-###25440374
-OBJECTIVE	The purpose of the study was to evaluate the clinical effects of the Shenzhu Tiaopi granule ( SZTP ) combined with a lifestyle intervention in patients with impaired glucose tolerance ( IGT ) , who also had a spleen deficiency and damp overabundance syndrome ( SDDOS ) .
-METHODS	After a one-month washout period , a total of 514 patients were randomly assigned to the control ( lifestyle intervention ) and experimental ( SZTP plus lifestyle intervention ) groups , with 257 patients in each group .
-METHODS	Patients in the control group received the lifestyle intervention ( diet and exercise ) for 12 months , while the patients in the experimental group were treated with SZTP plus the lifestyle intervention for 12 months .
-METHODS	The Traditional Chinese Medicinal ( TCM ) symptom scores were observed in each group before and after treatment ; the conversion rates from IGT to diabetes mellitus ( DM ) were also measured .
-RESULTS	Following 12 months of treatment , the conversion rate from IGT to DM in the experimental group was significantly lower than in the control group ( 8.52 % vs. 15.28 % , P < 0.05 ) .
-RESULTS	A significantly higher number of patients with IGT reverted to normal blood glucose levels in the experimental group than in the control group ( 42.15 % vs. 32.87 % , P < 0.05 ) .
-RESULTS	In addition , after following the treatment for 12 months , the TCM symptoms of patients in the experimental group were markedly alleviated , as compared to the control group ( P < 0.01 ) .
-CONCLUSIONS	The combination of SZTP and lifestyle intervention showed a reduction in the conversion from IGT to DM , and an increase in the conversion from IGT to normal blood glucose levels .
-
-###24418672
-OBJECTIVE	To determine whether a single bout of resistance exercise produces an analgesic effect in individuals with knee osteoarthritis ( OA ) .
-METHODS	Eleven participants with knee OA ( 65.9 10.4 yrs ) , and 11 old ( 61.3 8.2 yrs ) and 11 young ( 25.0 4.9 yrs ) healthy adults performed separate bouts of upper and lower body resistance exercise .
-METHODS	Baseline and post-exercise pressure pain thresholds were measured at eight sites across the body and pressure pain tolerance was measured at the knee .
-RESULTS	Pressure pain thresholds increased following exercise for all three groups , indicating reduced pain sensitivity .
-RESULTS	For the young and old healthy groups this exercise-induced analgesia ( EIA ) occurred following upper or lower body resistance exercise .
-RESULTS	In contrast , only upper body exercise significantly raised pain thresholds in the knee OA group , with variable non-significant effects following lower body exercise .
-RESULTS	Pressure pain tolerance was unchanged in all groups following either upper or lower body exercise .
-CONCLUSIONS	An acute bout of upper or lower body exercise evoked a systemic decrease in pain sensitivity in healthy individuals irrespective of age .
-CONCLUSIONS	The decreased pain sensitivity following resistance exercise can be attributed to changes in pain thresholds , not pain tolerance .
-CONCLUSIONS	While individuals with knee OA experienced EIA , a systemic decrease in pain sensitivity was only evident following upper body exercise .
-
-###24980238
-BACKGROUND	After vidian neurectomy , low reported rates of dry eye syndrome ( DES ) seemed incompatible with the high success rate of nerve severance in previous studies .
-BACKGROUND	This study aimed at understanding of the pathophysiology of lacrimation and evaluating the effect of thermal injury through the distal stump on the sphenopalatine ganglion ( SPG ) after vidian neurectomy .
-METHODS	A randomized , double-blind , controlled study was performed to evaluate the DES .
-METHODS	Eighty precise vidian neurectomies were randomized in a 1:1 ratio to groups 1 and 2 .
-METHODS	Group 1 represented the cauterization and was used in both distal and proximal nerve stumps , whereas only the proximal nerve stump was cauterized in group 2 subjects .
-METHODS	The DES was evaluated with Schirmer 's test and ocular surface disease index ( OSDI ) before and after surgery at 7-10 days and 30 days , respectively .
-RESULTS	In group 1 , the Schirmer 's test showed a mean decline of 20 mm ( 20/30 , 66 % ) at 7-10 days and 15 mm ( 15/30 , 50 % ) at 30 days .
-RESULTS	In group 2 , the Schirmer 's test revealed significantly lesser dry eye problems , with a mean decline of 16 mm ( 16/30 ; 52 % ) at 7-10 days and 2 mm ( 2/30 ; 6 % ) at 30 days .
-RESULTS	The significantly less postoperative dry eye problems in group 2 can be shown by the OSDI at 7-10 days , but not at 30 days .
-RESULTS	The mean follow-up period was 24 months .
-RESULTS	No recurrence of nasal allergy symptoms was noted in the follow up period .
-CONCLUSIONS	The significant advantage of preservation of the SPG function is justified by Schirmer 's test , although the effect did not appear to be comparable with the clinical manifestations evaluated by OSDI at 30 days .
-CONCLUSIONS	Nevertheless , the preservation of distal stump from preventive cauterization can still offer better eye ball moisture in the early evaluation of DES .
-
-###24628966
-OBJECTIVE	To investigate the effect of flavonoid-rich dark chocolate and non-flavonoid-rich white chocolate on retinal vessel diameter in glaucoma patients and age-matched controls .
-METHODS	Thirty glaucoma patients and 30 age-matched subjects were assigned to dark or white chocolate by randomization with forced equal distribution .
-METHODS	The number in each of the four groups was 15 .
-METHODS	Measured parameters included systemic blood pressure ( BP ) , blood glucose levels , static retinal vessel analysis , as measured by central retinal artery equivalent ( CRAE ) ( which relates to the diameter of the central retinal artery ) , central retinal vein equivalent ( CRVE ) ( which relates to the diameter of central retinal vein ) and the arterio-venous ratio ( AVR ) , which represents the CRAE/CRVE ratio , dynamic retinal vessel analysis as measured by the change in vessel diameter in response to flicker light stimulation .
-METHODS	Three recording cycles from each were averaged .
-RESULTS	Blood pressure parameters ( systolic BP , diastolic BP and pulse ) , IOP and blood glucose levels did not differ significantly between both groups before and after consumption of white or dark chocolate .
-RESULTS	Static vessel analysis did not show any significant changes in CRAE , CRVE or AVR before and after dark or white chocolate in both groups ( p > 0.05 ) .
-RESULTS	Mean dilatation of the venules in the control group was 3.2 0.9 % before dark chocolate and 4.2 1.4 % after dark chocolate intake , which was statistically significantly different ( p = 0.01 ) .
-RESULTS	Mean dilatation of the arterioles in the control group was 2.8 1.8 % before dark chocolate and 3.5 1.8 % after dark chocolate intake with a trend to statistical significance ( p = 0.14 ) , but not reaching the significance level .
-RESULTS	Mean diameter changes in the glaucoma group did not show any significant differences after dark chocolate consumption .
-CONCLUSIONS	The present study showed a significant improvement of venous vasodilatation 2 hr after dark chocolate intake in the control group , but not in the glaucoma group .
-CONCLUSIONS	This effect might be indicative of an increased bioavailability of nitric oxide ( NO ) after dark chocolate consumption .
-CONCLUSIONS	The lack of finding a significant venous response after dark chocolate in the glaucoma group might be related to the already impaired endothelial function in these patients .
-
-###25273991
-BACKGROUND	The United States has the highest rate of lumbar spine surgery in the world , with rates increasing over 200 % since 1990 .
-BACKGROUND	Medicare spends over $ 1 billion annually on lumbar spine surgery .
-BACKGROUND	Despite surgical advances , up to 40 % of patients report chronic pain and disability following surgery .
-BACKGROUND	Our work has demonstrated that fear of movement is a risk factor for increased pain and disability and decreased physical function in patients following lumbar spine surgery for degenerative conditions .
-BACKGROUND	Cognitive-behavioral therapy and self-management treatments have the potential to address psychosocial risk factors and improve outcomes after spine surgery , but are unavailable or insufficiently adapted for postoperative care .
-BACKGROUND	Our research team developed a cognitive-behavioral based self-management approach to postoperative rehabilitation ( Changing Behavior through Physical Therapy ( CBPT ) ) .
-BACKGROUND	Pilot testing of the CBPT program demonstrated greater improvement in pain , disability , physical and mental health , and physical performance compared to education .
-BACKGROUND	The current study compares which of two treatments provided by telephone - a CBPT Program or an Education Program about postoperative recovery - are more effective for improving patient-centered outcomes in adults following lumbar spine surgery for degenerative conditions .
-METHODS	A multi-center , comparative effectiveness trial will be conducted .
-METHODS	Two hundred and sixty patients undergoing lumbar spine surgery for degenerative conditions will be recruited from two medical centers and community surgical practices .
-METHODS	Participants will be randomly assigned to CBPT or Education at 6weeks following surgery .
-METHODS	Treatments consist of six weekly telephone sessions with a trained physical therapist .
-METHODS	The primary outcome will be disability and secondary outcomes include pain , general health , and physical activity .
-METHODS	Outcomes will be assessed preoperatively and at 6weeks , 6months and 12months after surgery by an assessor masked to group allocation .
-CONCLUSIONS	Effective rehabilitation treatments that can guide clinicians in their recommendations , and patients in their actions will have the potential to effect change in current clinical practice .
-BACKGROUND	NCT02184143 .
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-###26196084
-OBJECTIVE	To evaluate operative time after adjunctive misoprostol or mifepristone compared with overnight osmotic dilators alone for cervical preparation before dilation and evacuation at 16-23 6/7 weeks of gestation .
-METHODS	This double-blind , three-arm , multicenter , randomized trial compared overnight osmotic dilators alone , dilators plus 400 micrograms buccal misoprostol 3 hours preoperatively , and dilators plus 200 mg oral mifepristone during dilator placement for dilation and evacuation .
-METHODS	Our primary outcome was dilation and evacuation operative time within two cohorts : 16-18 6/7 weeks of gestation ( N = 150 ) and 19-23 6/7 weeks of gestation ( N = 150 ) .
-METHODS	Three hundred women were required for 80 % power to detect a 2-minute difference in operative time .
-METHODS	Secondary outcomes included initial cervical dilation , side effects , physician satisfaction by Likert scale , and complications .
-RESULTS	Between February 2013 and February 2014 we randomized 300 women evenly across treatment arms .
-RESULTS	Group demographics were similar .
-RESULTS	We found no difference in operative time in either gestational cohort ( early cohort [ minutes ] : 5.113.0 dilators alone , 4.993.3 misoprostol , 4.332.0 mifepristone , P = .34 ; late cohort [ minutes ] : 7.503.7 dilators alone , 7.625.4 misoprostol , 6.743.2 mifepristone , P = .53 ) .
-RESULTS	In the early cohort , initial dilation was greater with misoprostol than dilators alone ( 2.4 compared with 2.0 cm , P = .007 ) .
-RESULTS	Patients given misoprostol had significantly more pain , fever , and chills .
-RESULTS	In the late cohort , dilation and evacuation procedures were less difficult after mifepristone ( 4.1 % , 95 % confidence interval [ CI ] 0.0-9 .6 ) than misoprostol ( 18.8 % , 95 % CI 7.7-29 .8 ) or dilators alone ( 18.8 % , 95 % CI 7.7-29 .8 ; P = .04 ) .
-RESULTS	We had inadequate power to infer differences in complications : dilators alone ( 10 % , 95 % CI 4.2-16 .0 ) compared with misoprostol ( 2 % , 95 % CI 0-4 .7 ) compared with mifepristone ( 2 % , 95 % CI 0-4 .8 ) .
-CONCLUSIONS	Despite no difference in operative time , adjunctive mifepristone facilitates later dilation and evacuation compared with osmotic dilators alone and is better tolerated than misoprostol .
-BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01751087 .
-METHODS	I.
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-###25584489
-BACKGROUND	Rilotumumab , an investigational , monoclonal antibody , inhibits MET-mediated signalling .
-BACKGROUND	In a randomized phase 2 trial of rilotumumabepirubicin/cisplatin/capecitabine in gastric or oesophagogastric junction cancer , patients receiving rilotumumab showed a trend towards improved survival , especially in MET-positive patients , but no clear dose-response relationship was observed .
-BACKGROUND	Exposure-response and biomarker analyses were used for dose selection and to differentiate patient subpopulations that may benefit most from treatment .
-BACKGROUND	Here , we analyse rilotumumab exposure-survival and exposure-safety and the impact of MET expression on these relationships .
-METHODS	Individual rilotumumab exposure parameters were generated using population pharmacokinetic modelling .
-METHODS	Relationships among rilotumumab dose ( 7.5 and 15mgkg ( -1 ) ) , exposure , and clinical outcomes ( progression-free survival ( PFS ) and overall survival ( OS ) ) were evaluated with Cox regression models and Kaplan-Meier plots .
-METHODS	MET status and other baseline covariates were evaluated in subgroup and multivariate analyses .
-METHODS	Treatment-emergent adverse events were summarised by exposure .
-RESULTS	Among MET-positive patients , higher rilotumumab exposure , vs placebo and low exposure , was associated with improved median PFS ( 80 % CI : 7.0 ( 5.7-9 .7 ) vs 4.4 ( 2.9-4 .9 ) and 5.5 ( 4.2-6 .8 ) months ) and OS ( 13.4 ( 10.6-18 .6 ) vs 5.7 ( 4.7-10 .2 ) and 8.1 ( 6.9-11 .1 ) months ) without increased toxicity .
-RESULTS	No rilotumumab benefit was seen among MET-negative patients .
-CONCLUSIONS	Rilotumumab had an exposure-dependent treatment effect in patients with MET-positive gastric or oesophagogastric junction cancer .
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-###25450879
-BACKGROUND	Neoangiogenesis is particularly abundant in small-cell lung cancer ( SCLC ) and is associated with poor prognosis .
-BACKGROUND	As a result of the promising nature of phase II studies , a randomized phase III trial was designed to assess the efficacy of adding bevacizumab to first-line chemotherapy with cisplatin-etoposide for treatment of extensive disease SCLC .
-BACKGROUND	We present the treatment rationale and study design of GOIRC trial ( FARM6PMFJM study ) , a multicenter randomized phase III study , supported by AIFA ( Agenzia Italiana del Farmaco ) .
-METHODS	Patients are randomized to receive either cisplatin 25 mg/m ( 2 ) and etoposide 100 mg/m ( 2 ) intravenously on days 1 to 3 ( control arm ) or the same chemotherapy combined with bevacizumab 7.5 mg/kg intravenously on day 1 ( experimental arm ) .
-METHODS	Treatment is repeated every 3 weeks and for a maximum of 6 courses .
-METHODS	Patients randomized to the experimental arm in the absence of disease progression after 6 cycles continue bevacizumab alone until progression or for a maximum of 18 courses .
-METHODS	Tumor assessment is done every 3 cycles .
-METHODS	Major eligibility criteria are : age 18 years ; histologically or cytologically documented extensive disease SCLC ; Eastern Cooperative Oncology Group performance status 2 ; adequate hematological , hepatic and renal functions ; no history of grade 2 or higher hemoptysis ; and no evidence of tumor cavitation .
-METHODS	The primary end point of this study is overall survival .
-METHODS	Secondary end points include response rate , time to progression , and toxicity .
-CONCLUSIONS	An interim futility analysis was performed by an Independent Data Monitoring Committee in September 2013 and the trial obtained approval to continue .
-CONCLUSIONS	As of July 31 , 2014 , 171 patients of 206 planned have been randomized .
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-###25439055
-BACKGROUND	Severe mental illness ( SMI ) , including schizophrenia , bipolar disorder and severe depression , is responsible for a substantial proportion of disability in the population .
-BACKGROUND	This article describes the aims and design of a research study that takes a novel approach to targeted prevention of SMI .
-BACKGROUND	It is based on the rationale that early developmental antecedents to SMI are likely to be more malleable than fully developed mood or psychotic disorders and that low-risk interventions targeting antecedents may reduce the risk of SMI .
-METHODS	Families Overcoming Risks and Building Opportunities for Well-being ( FORBOW ) is an accelerated cohort study that includes a large proportion of offspring of parents with SMI and embeds intervention trials in a cohort multiple randomized controlled trial ( cmRCT ) design .
-METHODS	Antecedents are conditions of the individual that are distressing but not severely impairing , predict SMI with moderate-to-large effect sizes and precede the onset of SMI by at least several years .
-METHODS	FORBOW focuses on the following antecedents : affective lability , anxiety , psychotic-like experiences , basic symptoms , sleep problems , somatic symptoms , cannabis use and cognitive delay .
-METHODS	Enrolment of offspring over a broad age range ( 0 to 21 years ) will allow researchers to draw conclusions on a longer developmental period from a study of shorter duration .
-METHODS	Annual assessments cover a full range of psychopathology , cognitive abilities , eligibility criteria for interventions and outcomes .
-METHODS	Pre-emptive early interventions ( PEI ) will include skill training for parents of younger children and courses in emotional well-being skills based on cognitive behavioural therapy for older children and youth .
-METHODS	A sample enriched for familial risk of SMI will enhance statistical power for testing the efficacy of PEI .
-CONCLUSIONS	FORBOW offers a platform for efficient and unbiased testing of interventions selected according to best available evidence .
-CONCLUSIONS	Since few differences exist between familial and ` sporadic ' SMI , the same interventions are likely to be effective in the general population .
-CONCLUSIONS	Comparison of short-term efficacy of PEI on antecedents and the long term efficacy for preventing the onset of SMI will provide an experimental test of the etiological role of antecedents in the development of SMI .
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-###26267983
-OBJECTIVE	To evaluate the effectiveness of naproxen 500 mg taken orally 30 minutes before , endometrial biopsy for pain relief during the procedure .
-METHODS	A double blind , randomized , placebo-controlled trial was conducted in 80 patients with indication for endometrial biopsy at Ramathibodi Hospital between April 2013 and January 2014 .
-METHODS	The patients were randomly allocated into two groups to receive naproxen 500 mg ( n = 40 ) or placebo ( n = 40 ) , 30 minutes before endometrial biopsy .
-METHODS	Pain score was assessed using Visual Analogue Scale during and 10 minutes after the procedure .
-METHODS	Adverse events were observed .
-RESULTS	The mean pain score during endometrial biopsy in the treatment group was significantly lower compared to the placebo group ( 5.11 0.18 vs. 6.49 0.17 , respectively , p-value < 0.001 ) .
-RESULTS	However , the mean pain score at 10 minutes after endometrial sampling were minimal and had non-statistical significance in both groups .
-RESULTS	( 0.60 0.56 vs. 0.59 0.64 , p-value 0.971 ) .
-CONCLUSIONS	Naproxen 500 mg taken orally 30 minutes before endometrial biopsy significantly reduce pain score during the procedure .
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-###24849439
-OBJECTIVE	To investigate the effects of different anesthesia depth on stress response in elderly patients undergoing elective laparoscopic surgery for colorectal cancer .
-METHODS	A total of 105 ASA I-III patients aged 60-91 years undergoing elective laparoscopic surgery for colorectal cancer with general anesthesia were randomized into 3 groups , namely group A with a target Narcotrend index ( NI ) maintained at D0 level , group B with a NI at D2 level , and group C with a NI at E1 level .
-METHODS	The anesthetics ( profopol and remifentanil ) were adjusted according to Narcotrend monitoring results to maintain the specified anesthesia depth .
-METHODS	The patients ' heart rate ( HR ) and mean artery pressure ( MAP ) were recorded before anesthesia ( T0 ) , before intubation ( T1 ) , immediately after intubation ( T2 ) , at 2 min before pneumoperitoneum ( T3 ) , 2 min after pneumoperitoneum ( T4 ) , at the end of the surgery ( T5 ) and extubation ( T6 ) .
-METHODS	Serum levels of cortisol , adrenocorticotropic hormone ( ACTH ) , endothelin-1 ( ET-1 ) , tumor necrosis factor - ( TNF - ) , interleukin-6 ( IL-6 ) and C-reactive protein ( CRP ) were measured by standard ELISA and radioimmunoassay before anesthesia ( Ta ) , at the end of the surgery ( Tb ) and 1 day after the surgery ( Tc ) .
-RESULTS	HR and MAP in group A increased significantly at T2 , T4 , and T6 compared to those at T0 ( P < 0.05 ) , and were higher than those in group B and group C ( P < 0.05 ) .
-RESULTS	The MAP in all the 3 groups all decreased at T1 and T3 ( P < 0.05 or P < 0.01 ) , and was markedly lower in group C than in groups A and B ( P < 0.05 ) .
-RESULTS	The incidence of hypertension was significantly higher in group A than in groups B and C ( P < 0.05 ) , while the incidence of hypotension was much higher in group C ( P < 0.01 ) .
-RESULTS	There were no obvious differences in serum levels of cortisol , ACTH , CRP , IL-6 , TNF-a , or ET-1 among the groups at Ta ( P > 0.05 ) .
-RESULTS	The serum levels of ACTH in the 3 groups all significantly increased at Tb and Tc ( P < 0.01 ) .
-RESULTS	CRP , IL-6 and TNF-a levels in group A were increased at Tb and Tc ( P < 0.05 or P < 0.01 ) and significantly higher than those in groups B and C ( P < 0.05 or P < 0.01 ) .
-RESULTS	Cortisol in groups A and B increased at Tb and Tc ( P < 0.05 ) to a significantly higher level than that in group C ( P < 0.01 ) .
-RESULTS	ET-1 level in group C at Tb and Tc was lower than those in groups A and B ( P < 0.05 or P < 0.01 ) .
-CONCLUSIONS	Maintaining the anesthesia depth for a NI at the D2 and E1 level can both attenuate the stress response in elderly patients undergoing laparoscopic surgery for colorectal cancer , but the hemodynamic stability can be better at a D2 level .
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-###25156622
-BACKGROUND	The study purpose was to analyze midterm outcomes in a prospective trial of alemtuzumab ( Alem ) versus rabbit anti-thymocyte globulin ( rATG ) induction in simultaneous pancreas-kidney transplantation ( SPKT ) .
-METHODS	From February 2005 to October 2008 , 46 SPKTs ( 45 portal-enteric drainage ) were prospectively randomized as part of a larger kidney transplant study to receive either single-dose Alem ( 30 mg intraoperatively ) or multiple-dose rATG antibody induction ( starting intraoperatively , minimum three doses administered ) with tacrolimus/mycophenolate steroids .
-RESULTS	Of 222 kidney transplant patients enrolled in the study , 46 received SPKTs ; 28 ( 61 % ) received Alem and 18 ( 39 % ) rATG induction .
-RESULTS	Follow-up ranged from 67 to 111 months ( mean 80 months ) .
-RESULTS	There were no significant differences between the two groups in 5 years actual patient ( 86 % Alem vs 89 % rATG ) , kidney ( 82 % Alem vs 61 % rATG , p = 0.17 ) or pancreas ( 68 % Alem vs 56 % rATG ) graft survival rates .
-RESULTS	Five years death-censored kidney ( 92 % Alem vs 69 % rATG , p = 0.09 ) and pancreas ( 76 % Alem vs 56 % rATG , p = 0.198 ) graft survival rates were slightly higher in patients receiving Alem .
-RESULTS	Acute rejection ( 21 % Alem vs 44 % rATG , p = 0.12 ) and major infection ( 39 % Alem vs 67 % rATG , p = 0.13 ) rates were slightly lower in the Alem group ; cytomegalovirus infections were significantly lower ( 0 Alem vs 17 % rATG , p = 0.05 ) .
-RESULTS	The incidence of late acute rejection was low in both groups .
-RESULTS	There were no differences in early pancreas thrombosis ( 3.6 % Alem vs 11 % rATG ) , postoperative bleeding ( 11 % Alem vs 0 rATG ) , other surgical complications , readmissions or freedom from steroids between groups .
-RESULTS	In patients with functioning grafts , 5 years mean serum creatinine ( 1.4 Alem vs 1.6 mg/dl rATG ) , calculated abbreviated modification of diet in renal disease glomerular filtration rate ( 55 Alem vs 52 ml/min/1 .73 m ( 2 ) rATG ) , hemoglobin A1c ( both 5.4 % ) and C-peptide ( 2.6 Alem vs 2.3 ng/ml rATG ) levels were similar .
-CONCLUSIONS	Single-dose Alem and multiple-dose rATG induction provide similar midterm patient survival and graft functional outcomes with no major differences in morbidity or resource utilization .
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-###25028655
-BACKGROUND	The aim of this investigation is to study the relationship between gastric morphology and serum biomarkers before and after Helicobacter pylori eradication .
-METHODS	First-degree relatives of gastric cancer patients underwent gastroscopy before and 2.5 years after H. pylori eradication .
-METHODS	The morphological changes in two categories ( normal to mild and moderate to severe ) were compared with level of pepsinogens I and II before eradication ( n = 369 ) , after eradication ( n = 115 ) , and in those with persistent infection ( n = 250 ) .
-RESULTS	After eradication , pepsinogen I decreased to 70 % and pepsinogen II to 45 % of the previous values .
-RESULTS	Unlike pepsinogen II and pepsinogen I to II ratio that were affected by the severity of inflammation and atrophy in corpus in all groups , pepsinogen I generally did not change .
-RESULTS	After eradication , subjects with high mononuclear infiltration in corpus had lower pepsinogen I ( 54 versus 77.1 / mL ) , higher pepsinogen II ( 9.4 versus 6.9 / mL ) , and lower ratio ( 7.9 versus 11.6 ) than those without ( P < 0.05 ) .
-CONCLUSIONS	Pepsinogen II is a good marker of corpus morphological changes before and after H. pylori eradication .
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-###25046946
-OBJECTIVE	To study the efficacy of Xiaoyao Powder ( XYP ) combined with interferon alpha ( IFN-alpha ) in treating HBeAg positive chronic hepatitis B ( CHB ) patients and the effect on their quality of life ( QOL ) .
-METHODS	Totally 193 patients with HBeAg-positive CHB confirmed by liver biopsy were randomly assigned to 2 groups , Group A ( 94 cases ) and Group B ( 99 cases ) .
-METHODS	IFN-alpha1b was subcutaneously injected to patients in Group A at the dose of 50 microg , thrice per week .
-METHODS	Those in Group B additionally took XYP .
-METHODS	The therapeutic course for all was 24 weeks .
-METHODS	Clinical efficacy was observed by assessing ALT restoration rate , HBeAg negative rate , HBeAg conversion rate , HBV DNA negative rate , complete response rate , partial response rate , and symptoms integral .
-METHODS	The evaluation of QOL was performed by using chronic liver disease questionnaire ( CLDQ ) score .
-METHODS	Adverse reaction occurrence rate was observed in the two groups .
-RESULTS	Better effects were obtained in Group A on ALT restoration rate , HBeAg negative rate , HBV DNA negative rate , complete response rate , partial response rate , TCM symptoms integral , the total effective rate of TCM sysmptoms , CLDQ score , and adverse reaction rates , showing statistical difference when compared with Group B ( P < 0.05 , P < 0.01 ) .
-CONCLUSIONS	XYP could elevate the efficacy of TCM symptoms of HBeAg-positive CHB patients and anti-viral effect , improve their QOL , and reduce adverse reaction of IFN-alpha .
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-###24491642
-OBJECTIVE	To evaluate long-term efficacy and safety profiles during 3 years of individualized ranibizumab treatment in patients with visual impairment due to diabetic macular edema ( DME ) .
-METHODS	Phase IIIb , multicenter , 12-month , randomized core study and 24-month open-label extension study .
-METHODS	Of the 303 patients who completed the randomized RESTORE 12-month core study , 240 entered the extension study .
-METHODS	In the extension study , patients were eligible to receive individualized ranibizumab treatment as of month 12 guided by best-corrected visual acuity ( BCVA ) and disease progression criteria at the investigators ' discretion .
-METHODS	Concomitant laser treatment was allowed according to the Early Treatment Diabetic Retinopathy Study guidelines .
-METHODS	Based on the treatments received in the core study , the extension study groups were referred to as prior ranibizumab , prior ranibizumab + laser , and laser .
-METHODS	Change in BCVA and incidence of ocular and nonocular adverse events ( AEs ) over 3 years .
-RESULTS	Overall , 208 patients ( 86.7 % ) completed the extension study .
-RESULTS	In patients treated with ranibizumab during the core study , consecutive individualized ranibizumab treatment during the extension study led to an overall maintenance of BCVA and central retinal subfield thickness ( CRST ) observed at month 12 over the 2-year extension study ( +8.0 letters , -142.1 m [ prior ranibizumab ] and +6.7 letters , -145.9 m [ prior ranibizumab + laser ] from baseline at month 36 ) with a median of 6.0 injections ( mean , 6.8 injections ; prior ranibizumab ) and 4.0 ( mean , 6.0 injections ; prior ranibizumab + laser ) .
-RESULTS	In the prior laser group , a progressive BCVA improvement ( +6.0 letters ) and CRST reduction ( -142.7 m ) at month 36 were observed after allowing ranibizumab during the extension study , with a median of 4.0 injections ( mean , 6.5 injections ) from months 12 to 35 .
-RESULTS	Patients in all 3 treatment groups received a mean of < 3 injections in the final year .
-RESULTS	No cases of endophthalmitis , retinal tear , or retinal detachment were reported .
-RESULTS	The most frequently reported ocular and nonocular adverse effects over 3 years were cataract ( 16.3 % ) and nasopharyngitis ( 23.3 % ) .
-RESULTS	Eight deaths were reported during the extension study , but none were suspected to be related to the study drug/procedure .
-CONCLUSIONS	Ranibizumab was effective in improving and maintaining BCVA and CRST outcomes with a progressively declining number of injections over 3 years of individualized dosing .
-CONCLUSIONS	Ranibizumab was generally well tolerated with no new safety concerns over 3 years .
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-###24708851
-BACKGROUND	Physical therapy treatment of patients with lymphedema includes treatment based on the principles of ` Complete Decongestive Therapy ' ( CDT ) .
-BACKGROUND	CDT consists of the following components ; skin care , manual lymphatic drainage , bandaging and exercises .
-BACKGROUND	The scientific evidence regarding what type of treatment is most effective is sparse .
-BACKGROUND	The objective of this study is to investigate whether CDT is equally effective if it includes manual lymphatic drainage or not in the treatment of arm lymphedema among patients with breast cancer .
-METHODS	A randomized , single-blind , equivalence trial .
-METHODS	A total of 160 breast cancer patients with arm lymphedema will be recruited from 3 hospitals and randomized into one of two treatment groups A : Complete Decongestive Therapy including manual drainage or B : Complete Decongestive Therapy without manual lymphatic drainage .
-METHODS	The intervention period will be approximately 4 weeks followed by a 6 month follow-up period ( 7 months from baseline ) .
-METHODS	Primary outcome variable : the percentage volume reduction of lymphedema ( % ) from baseline to 7 months .
-METHODS	Secondary outcome variables : Differences from baseline to week 4 and from week 4 to month 7 in circumference of the arm ( cm ) , body weight ( kg ) , patient sensation of heaviness ( scale range : 0-10 ) , patient sensation of tension ( scale range : 0-10 ) , and quality of life ( EQ-5D-5 L-questionnaire ) .
-METHODS	All measurements are standardized and will be performed before randomization , after 4 weeks and after 7 months .
-CONCLUSIONS	This randomized controlled study seeks to provide data on an effective treatment for patients with breast cancer related arm lymphedema and which at the same time causes minimal patient inconvenience .
-BACKGROUND	ClinicalTrials.gov : Identifier NCT02015897 .
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-###25134117
-OBJECTIVE	To determine the effects of lipid based nutritional supplements with either whey or soy protein in patients with HIV during the first three months of antiretroviral treatment ( ART ) and to explore effects of timing by comparing supplementation at the start of ART and after three months delay .
-METHODS	Randomised controlled trial .
-METHODS	Three public ART facilities in Jimma , Oromia region , Ethiopia .
-METHODS	Adults with HIV eligible for ART with body mass index ( BMI ) > 16 .
-METHODS	Daily supplementation with 200 g ( 4600 kJ ) of supplement containing whey or soy during either the first three or the subsequent three months of ART .
-METHODS	Primary : lean body mass assessed with deuterium dilution , grip strength measured with dynamometers , and physical activity measured with accelerometer and heart rate monitors .
-METHODS	Secondary : viral load and CD4 counts .
-METHODS	Auxiliary : weight and CD3 and CD8 counts .
-RESULTS	Of 318 patients enrolled , 210 ( 66 % ) were women , mean age was 33 ( SD 9 ) , and mean BMI was 19.5 ( SD 2.4 ) .
-RESULTS	At three months , participants receiving the supplements containing whey or soy had increased their lean body mass by 0.85 kg ( 95 % confidence interval 0.16 kg to 1.53 kg ) and 0.97 kg ( 0.29 kg to 1.64 kg ) , respectively , more than controls .
-RESULTS	This was accompanied by an increased gain of grip strength of 0.68 kg ( -0.11 kg to 1.46 kg ) for the whey supplement group and 0.93 kg ( 0.16 kg to 1.70 kg ) for the soy supplement group .
-RESULTS	There were no effects on physical activity .
-RESULTS	Total weight gain increased by 2.05 kg ( 1.12 kg to 2.99 kg ) and 2.06 kg ( 1.14 kg to 2.97 kg ) for the whey and soy groups , respectively .
-RESULTS	In addition , in the whey supplement group overall CD3 counts improved by 150 cells/L ( 24 to 275 cells/L ) , of which 112 cells/L ( 15 to 209 cells/L ) were CD8 and 25 cells/L ( -2 to 53 cells/L ) were CD4 .
-RESULTS	Effects of the soy containing supplement on immune recovery were not significant .
-RESULTS	The effects of the two supplements , however , were not significantly different in direct comparison .
-RESULTS	Exploratory analysis showed that relatively more lean body mass was gained by patients with undetectable viral load at three months .
-RESULTS	Patients receiving delayed supplementation had higher weight gain but lower gains in functional outcomes .
-CONCLUSIONS	Lipid based nutritional supplements improved gain of weight , lean body mass , and grip strength in patients with HIV starting ART .
-CONCLUSIONS	Supplements containing whey were associated with improved immune recovery .
-CONCLUSIONS	Trial registration Controlled-trials .
-CONCLUSIONS	com ISRCTN32453477 .
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-###26141466
-BACKGROUND	Daikenchuto ( DKT ) has widely been used to improve abdominal symptoms by being expected to accelerate bowel motility .
-BACKGROUND	The purpose of this study is to examine the efficacy and safety of DKT for prevention of ileus and associated gastrointestinal symptoms after total gastrectomy .
-METHODS	Two hundred and forty-five gastric cancer patients who underwent total gastrectomy were enrolled .
-METHODS	Patients received either DKT ( 15.0 g/d ) or matching placebo from postoperative days 1 to 12 .
-METHODS	Primary end points were time to first flatus , time to first bowel movement ( BM ) , and frequency of BM .
-METHODS	Secondary end points included quality of life , C-reactive protein level , symptoms indicative of a severe gastrointestinal disorder , and incidence of postoperative ileus .
-RESULTS	A total of 195 patients ( DKT , n = 96 ; placebo , n = 99 ) were included in the per-protocol set analysis .
-RESULTS	There were no significant differences between the groups in terms of patient background characteristics .
-RESULTS	Median time to first BM was shorter in the DKT group than in the placebo group ( 94.7 hours vs 113.9 hours ; p = 0.051 ) .
-RESULTS	In patients with high medication adherence , median time to first BM was significantly shorter in the DKT group than in the placebo group ( 93.8 hours vs 115.1 hours ; p = 0.014 ) .
-RESULTS	Significantly fewer patients in the DKT group had 2 symptoms of gastrointestinal dysfunction than those in the placebo group on postoperative day 12 ( p = 0.026 ) .
-CONCLUSIONS	Administration of DKT during the immediate postoperative period after total gastrectomy appears to promote early recovery of postoperative bowel function .
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-###25098260
-OBJECTIVE	To determine the effects of Ginkgo biloba extract ( EGB ) on major periodontal pathogens in subgingival plaque .
-METHODS	Sixty patients with moderate to severe periodontitis were selected and randomly assigned to 3 groups : EGB group , a positive ( periocline ) and a negative control groups .
-METHODS	Subgingival plaque samples were collected before treatment and 1 week , 2 months and 4 months after treatment .
-METHODS	The detection rates of 4 major periodontal pathogens-Treponema denticola ( Td ) , Tannerella forsythus ( Tf ) , Prevotella intermedia ( Pi ) , and Porphyromonas gingivalis ( Pg ) - were detected by polymerase chain reaction ( PCR ) .
-METHODS	Clinical indicators were examined before treatment , 3 and 6 months after treatment .
-RESULTS	EGB significantly decreased the detection rate of all the 4 pathogens 1 week after treatment , and then gradually increased at 2 and 4 months .
-RESULTS	EGB 's inhibition effect was better than or comparable to periocline , except for Pg in short-term .
-RESULTS	The difference of plaque index ( PLI ) and bleeding index ( BI ) was not statistically significant among the groups , while for probing depth ( PD ) and attachment loss ( AL ) , the difference was statistically significant between the EGB group and negative control group at 3 and 6 months after treatment .
-CONCLUSIONS	EGB significantly inhibited major periodontal pathogens and can be used as an adjuvant for periodontitis treatment .
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-###25785695
-OBJECTIVE	Instructional methods for the simple suture technique vary widely and are seldom based on educational research .
-OBJECTIVE	Published data indicate that video primers and structured instruction and evaluation decrease learning time and improve skill acquisition .
-OBJECTIVE	To determine the amount of practice needed to attain simple suture proficiency and to identify the optimal teaching schedule for retention of skill .
-METHODS	First-year and second-year medical students at the Icahn School of Medicine at Mount Sinai with little to no suturing experience were randomly divided into 2 equal groups , with one being taught on day 1 and tested for proficiency on day 30 ( control group ) and the other being taught on day 1 and tested for proficiency on days 10 , 20 , and 30 ( experimental group ) .
-METHODS	Students were evaluated using the objective structured assessment of technical skills method and a checklist .
-METHODS	Those initially not proficient on a given day were immediately prompted to practice and retest .
-METHODS	This cycle continued until proficiency was achieved for that day .
-METHODS	The study was conducted from April 7 , 2014 , to June 30 , 2014 .
-METHODS	Simple suture proficiency at 30 days and the mean number of practice sutures needed for proficiency on day 1 .
-RESULTS	All students ultimately achieved proficiency .
-RESULTS	The mean ( SD ) number of practice sutures required to achieve proficiency at the initial training was 41 ( 15 ) .
-RESULTS	Students in the control group had a 0 % pass rate at the 30-day initial proficiency test , while students in the experimental group had a 91.7 % pass rate at day 30 ( P < .001 ) .
-RESULTS	There were no differences in instructional time , cumulative number of sutures , or objective structured assessment of technical skills scores at proficiency between groups across the study .
-CONCLUSIONS	Single instructional sessions may not be sufficient to maintain simple suture proficiency over the course of a 30-day elective .
-CONCLUSIONS	We propose the use of preparatory instructional videos , followed by instructor demonstration to introduce the technique .
-CONCLUSIONS	Independent practice with intermittent evaluation and critique allows for skill acquisition and time efficiency at the initial training .
-CONCLUSIONS	Students should view instructional videos and practice at least 10 repetitions every 10 days to maintain their skill .
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-###24392703
-OBJECTIVE	There have been no studies of the effect of continuous positive airway pressure ( CPAP ) therapy on erectile dysfunction ( ED ) and serum testosterone in men with type 2 diabetes and obstructive sleep apnoea ( OSA ) , a patient group at increased risk of ED and hypogonadism .
-OBJECTIVE	The aim of this study was to determine whether CPAP improves sexual and gonadal function in males with type 2 diabetes and a pre-CPAP apnoea-hypopnoea index > 15/h .
-METHODS	Substudy of a trial assessing the effect of 3 months of CPAP on cardiovascular risk in type 2 diabetes .
-METHODS	Of 35 males starting CPAP , 27 ( mean SD age 65.4 9.6 years , median [ interquartile range ] diabetes duration 12.1 [ 5.2-15 .3 ] years ) completed the trial .
-METHODS	Serum total and free testosterone , responses to the Androgen Deficiency in the Aging Aale ( ADAM ) and Sexual Health Inventory for Men ( SHIM ) questionnaires .
-RESULTS	There were no significant changes in mean total or free testosterone ( baseline concentrations 12.7 4.5 nm and 0.26 0.07 pm , respectively ) , or SHIM score ( baseline 13 [ 5-17 ] ) , after 3 months of CPAP ( P > 0.20 ) .
-RESULTS	The ADAM score ( baseline 6.2 2.1 ) fell after 1 month ( to 5.0 2.6 ) and was maintained at this level at 3 months ( P = 0.015 ) .
-RESULTS	The Epworth Sleepiness Scale score decreased and self-reported physical activity increased over 3 months ( P 0.017 ) without a change in body mass index ( P = 1.00 ) .
-CONCLUSIONS	These findings imply that CPAP therapy improves somnolence and promotes exercise in men with type 2 diabetes , but that there is no direct benefit for gonadal or sexual function .
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-###24823461
-BACKGROUND	GH treatment significantly increased adult height ( AH ) in a dose-dependent manner in short non-GH-deficient children in a randomized , controlled , clinical trial ; the mean gain in height SD score ( heightSDS ) was 1.3 ( range 0-3 ) , compared with 0.2 in the untreated group .
-OBJECTIVE	The objective of the study was to analyze the relationship between IGF-1SDS , IGF binding protein-3 SDS ( IGFBP3SDS ) , and their ratioSDS with a gain in the heightSDS until AH in non-GH-deficient short children .
-METHODS	This was a randomized , controlled , multicenter clinical trial .
-METHODS	The intervention included GH treatment : 33 or 67 g/kg d plus untreated controls .
-METHODS	One hundred fifty-one non-GH-deficient short children were included in the intent-to-treat ( ITT ) population and 108 in the per-protocol ( PP ) population ; 112 children in the ITT and 68 children in the PP populations had idiopathic short stature ( ISS ) .
-METHODS	Increments from baseline to on-treatment study mean IGF-1SDS ( IGF-1SDS ) , IGFBP3SDS , and IGF-1 to IGFBP3 ratioSDS were assessed in relationship to the gain in heightSDS .
-RESULTS	Sixty-two percent of the variance in the gain in heightSDS in children on GH treatment could be explained by four variables : IGF-1SDS ( explaining 28 % ) , bone age delay , birth length ( the taller the better ) , and GH dose ( the higher the better ) .
-RESULTS	The lower IGF-1SDS was at baseline , the higher was its increment during treatment .
-RESULTS	For both the AllPP - and the ISSPP-treated groups , the attained IGF-1SDS study level did not correlate with height gain .
-CONCLUSIONS	In short non-GH-deficient children , the GH dose-related increment in IGF-1SDS from baseline to mean study level was the most important explanatory variable for long-term growth response from the peripubertal period until AH , when IGF-1SDS , IGFBP3SDS , and their ratioSDS were compared concurrently .
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-###24679247
-OBJECTIVE	The aim of the study was to compare intermittent ( IAD ) and continuous ( CAD ) androgen deprivation therapy ( ADT ) between locally advanced ( M0 ) and metastatic ( M1 ) prostate cancer , and the effect of ADT on the quality of life .
-METHODS	In total , 852 men with advanced prostate cancer were enrolled to receive goserelin acetate for 24 weeks .
-METHODS	Of these , 554 patients whose prostate-specific antigen ( PSA ) decreased to less than 10 ng/ml or by at least 50 % ( < 20 ng/ml at baseline ) were randomized to IAD or CAD .
-METHODS	In the IAD arm , ADT was resumed for at least 24 weeks whenever PSA increased to greater than 20 ng/ml or above baseline .
-RESULTS	Median follow-up time was 65 months .
-RESULTS	Median times from randomization to progression , death , prostate cancer death and treatment failure in M0 and M1 patients were 46.8 and 21.4 , 57.6 and 40.3 , 59.5 and 40.7 , and 41.9 and 20.0 months , respectively ( p < 0.001 ) .
-RESULTS	No significant differences emerged between IAD and CAD .
-RESULTS	ADT showed a beneficial effect on pain , activity limitation and social functioning in M1 patients , and a deleterious effect on physical capacity in M0 patients and on sexual functioning in both groups .
-RESULTS	IAD offered extra benefit for activity limitation , social functioning and recovery of sexual functioning .
-CONCLUSIONS	IAD is as efficient as CAD in treatment of locally advanced and metastatic prostate cancer .
-CONCLUSIONS	ADT improves quality of life in M1 patients , with IAD offering extra benefit .
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-###24382782
-BACKGROUND	Recombinant interleukin-2 ( rIL-2 ) induces cellular cytotoxicity against leukemia blasts .
-BACKGROUND	Patients with acute myeloid leukemia ( AML ) in first complete remission ( CR ) may harbor minimal residual disease that is susceptible to rIL-2-activated effector cells .
-METHODS	In the Cancer and Leukemia Group B ( CALGB ) 19808 study , patients with AML in first CR were randomly assigned after all planned chemotherapy to receive a 90-day course of subcutaneously administered rIL-2 or no further therapy .
-METHODS	The primary objective was to compare disease-free survival ( DFS ) between the 2 treatment arms .
-METHODS	A total of 534 patients achieved a CR , 214 of whom were randomized .
-METHODS	Six courses of low-dose daily rIL-2 were given for the expansion of cytotoxic effector cells , each followed by 3-day high-dose boluses given to trigger cytotoxicity against minimal residual disease .
-RESULTS	On the protocol-specified intention-to-treat analysis , the hazards ratio for DFS was 0.75 ( 95 % confidence interval , 0.52-1 .09 ; P = .13 ) ; the 5-year DFS rate was 42 % in the observation arm and 53 % in the rIL-2 treatment arm .
-RESULTS	The hazards ratio for overall survival ( OS ) was 0.88 ( 95 % confidence interval , 0.54-1 .23 ; P = .34 ) ; the 5-year OS rate was 58 % for the observation arm and 63 % for the rIL-2 treatment arm .
-RESULTS	Twenty-five of the 107 patients randomized to treatment with rIL-2 either refused or were unable to initiate therapy and 30 patients did not complete their assigned therapy .
-RESULTS	However , significant toxicities were not commonly observed .
-RESULTS	The trial design did not anticipate the difficulties patients would encounter with protocol compliance .
-CONCLUSIONS	The efficacy of immunotherapy with rIL-2 administered after intensive postremission treatment was not assessed as planned because of unexpected refusals by patients and/or their physicians to comply with protocol-directed therapy .
-CONCLUSIONS	Neither DFS nor OS was found to be significantly improved .
-
-###24673675
-OBJECTIVE	Older patients discharged from the emergency department ( ED ) have difficulty comprehending discharge plans and are at high risk of adverse outcomes .
-OBJECTIVE	The authors investigated whether a postdischarge telephone call-mediated intervention by a nurse would improve discharge care plan adherence , specifically by expediting post-ED visit physician follow-up appointments and/or compliance with medication changes .
-OBJECTIVE	The second objectives were to determine if this telephone call intervention would reduce return ED visits and/or hospitalizations within 35days of the index ED visit and to determine potential cost savings of this intervention .
-METHODS	This was a 10-week randomized , controlled trial among patients aged 65 and older discharged to home from an academic ED .
-METHODS	At 1 to 3days after each patient 's index ED visit , a trained nurse called intervention group patients to review discharge instructions and assist with discharge plan compliance ; placebo call group patients received a patient satisfaction survey call , while the control group patients were not called .
-METHODS	Data collection calls occurred at 5 to 8days and 30 to 35days after the index ED visits for all three groups .
-METHODS	Chi-square or Fisher 's exact tests were performed for categorical data and the Kruskal-Wallis test examined group differences in time to follow-up .
-RESULTS	A total of 120 patients completed the study .
-RESULTS	Patients were 60 % female and 72 % white , with a mean age of 75years ( standard deviation [ SD ] 7.58 years ) .
-RESULTS	Intervention patients were more likely to follow up with medical providers within 5days of their ED visits than either the placebo or the control group patients ( 54 , 20 , and 37 % , respectively ; p = 0.04 ) .
-RESULTS	All groups performed well in medication acquisition and comprehension of medication indications and dosage .
-RESULTS	There were no differences in return visits to the ED or hospital within 35days of the index ED visit for intervention patients , compared to placebo or control group patients ( 22 , 33 , and 27 % , respectively ; p = 0.41 ) .
-RESULTS	An economic analysis showed an estimated 70 % chance that this intervention would reduce total costs .
-CONCLUSIONS	Telephone call follow-up of older patients discharged from the ED resulted in expedited follow-up for patients with their primary care physicians .
-CONCLUSIONS	Further study is warranted to determine if these results translate into improved patient outcomes , decreased return ED visits or hospital admissions , and cost savings resulting from this intervention .
-
-###24397584
-OBJECTIVE	To compare characteristics of hypoglycemic episodes in patients with type 2 diabetes receiving saxagliptin or glipizide add-on therapy to metformin .
-METHODS	This was a post hoc analysis of an international , randomized , parallel-group , double-blind , active-controlled , phase 3 trial .
-METHODS	The 52-week trial and 52-week extension were conducted from December 2007 to August 2010 .
-METHODS	Patients aged 18 years with glycated hemoglobin ( HbA1c ) > 6.5 % to 10.0 % receiving stable metformin doses ( 1500mg/d ) were randomized 1:1 to add-on therapy with saxagliptin 5mg/d or glipizide 5 to 20mg/d ( titrated to optimal effect or highest tolerable dose during the initial 18 weeks ) .
-METHODS	Hypoglycemic episodes were recorded in patient diaries .
-METHODS	Confirmed hypoglycemic events were defined as fingerstick glucose 50mg/dL ( 2.8 mmol/L ) with associated symptoms .
-RESULTS	Of 858 patients randomized , 428 received saxagliptin + metformin , and 430 received glipizide + metformin .
-RESULTS	Saxagliptin was noninferior to glipizide in lowering HbA1c .
-RESULTS	Hypoglycemia with saxagliptin + metformin and glipizide + metformin was reported by 15 ( 24 events ) and 165 ( 896 events ) patients , respectively , through week 104 .
-RESULTS	The mean ( SD ) number of hypoglycemic events per patient reporting hypoglycemia was lower with saxagliptin + metformin versus glipizide + metformin through weeks 52 ( 1.5 [ SD 0.88 ] vs 4.8 [ SD 4.9 ] , respectively ) and 104 ( 1.6 [ SD 0.99 ] vs 5.4 [ SD 5.8 ] ) .
-RESULTS	Most patients receiving glipizide + metformin with hypoglycemia had multiple events ( 124/165 patients [ 75 % ] ) .
-RESULTS	Confirmed hypoglycemia , major events , and severe events occurred only with glipizide + metformin .
-RESULTS	Time to first hypoglycemic event was shorter with glipizide versus saxagliptin .
-RESULTS	Limitations of this analysis include its post hoc nature , a high rate of study discontinuation , and exclusion of patients with serious comorbidities and complications .
-CONCLUSIONS	Saxagliptin + metformin was associated with fewer patients reporting hypoglycemia and fewer and less severe hypoglycemic events in those experiencing hypoglycemia compared with glipizide + metformin .
-CONCLUSIONS	ClinicalTrials.gov registration number : NCT00575588 .
-
-###24745013
-BACKGROUND	This study is a comparative evaluation of the TVT , TOT , and our own modification of TOT ( mTOT ) in the treatment of female stress urinary incontinence from a single center experience .
-METHODS	The study was conducted on 527 patients with SUI diagnosed on the basis of urodynamic studies .
-METHODS	They were divided into three groups -- TVT : n = 142 , ( TOT ) : n = 129 , and mTOT : n = 256 .
-METHODS	All of the patients underwent evaluation at 1 , 3 , and 6 months after surgery .
-METHODS	Results were statistically analysed and compared .
-RESULTS	Objective and subjective effectiveness after the surgery were not significantly different in the study groups and ranged from 90.1 % to 96.4 % .
-RESULTS	Mean surgery time was 32.3 , 28.2 , and 26.4 in the TVT , TOT , and mTOT , respectively .
-RESULTS	Mean hospitalization time was 2.51 days .
-RESULTS	Mean catheter maintenance time was significantly higher in the TVT than in other groups .
-RESULTS	In the TVT group total incidence of complications was 13.4 % , and it was significantly higher than that in TOT and mTOT ( 9.3 % and 8.6 % , resp . )
-CONCLUSIONS	TVT , TOT , and mTOT are highly effective and safe methods in the treatment of SUI .
-CONCLUSIONS	There are no differences in the efficacy between the methods with a little higher percentage of complications in the TVT group .
-
-###24376252
-OBJECTIVE	The Lower Mississippi Delta ( LMD ) region of the United States is characterized by high levels of obesity and physical inactivity .
-OBJECTIVE	The objective was to test the effectiveness of adapting the 2010 Dietary Guidelines for Americans ( DG ) , with and without a physical activity ( PA ) component , for attenuating weight gain .
-METHODS	Overall , 121 white and African-American adults ( 35-64 years ; body mass index 25-34 .9 kg/m ( 2 ) ) were randomized to a DG only group ( n = 61 ) or a DG + PA group ( n = 60 ) .
-METHODS	Both groups received a 12-week dietary education and behavior change intervention .
-METHODS	The DG + PA group also received PA education and a pedometer .
-METHODS	Changes in weight ( kg ) , % weight , and waist circumference ( WC ; cm ) were determined .
-METHODS	Analyses considered all completers ( n = 99 ) and those who engaged with 80 % of the intervention ( n = 83 ) .
-METHODS	General linear models compared mean changes between groups after adjustment for baseline values , race , and sex .
-RESULTS	Weight , % weight , and WC significantly decreased from baseline to follow-up in both groups ( p < 0.05 ; unadjusted values ) .
-RESULTS	Adjusted analysis showed a main effect of group for weight ( p = 0.041 ) and % weight ( p = 0.047 ) in the completers analysis , and WC ( p = 0.046 ) in the 80 % attendance analysis , with the DG + PA group improving weight-related outcomes more .
-CONCLUSIONS	Low-burden behavioral interventions could be effective strategies in attenuating unhealthy weight gain in the LMD .
-
-###25283680
-OBJECTIVE	The goal of the present research was the examination of overlap between 2 research traditions on interpersonal personality traits in major depression .
-OBJECTIVE	We hypothesized that Blatt 's ( 2004 ) dimensions of depressive experiences around the dimensions of relatedness ( i.e. , dependency ) and self-definition ( i.e. , self-criticism ) are associated with specific interpersonal problems according to the interpersonal circumplex model ( Leary , 1957 ) .
-OBJECTIVE	In addition , we examined correlations of interpersonal characteristics with depression severity .
-METHODS	Analyses were conducted on 283 patients with major depressive disorder combined from 2 samples .
-METHODS	Of the patients , 151 participated in a randomized controlled trial in the United States , and 132 patients were recruited in an inpatient unit in Germany .
-METHODS	Patients completed measures of symptomatic distress , interpersonal problems , and depressive experiences .
-RESULTS	Dependency was associated with more interpersonal problems related to low dominance and high affiliation , while self-criticism was associated with more interpersonal problems related to low affiliation .
-RESULTS	These associations were independent of depression severity .
-RESULTS	Self-criticism showed high overlap with cognitive symptoms of depression .
-CONCLUSIONS	The findings support the interpersonal nature of Blatt 's dimensions of depressive experiences .
-CONCLUSIONS	Self-criticism is associated with being too distant or cold toward others as well as greater depression severity , but is not related to the dimension of dominance .
-
-###25458200
-BACKGROUND	Long-term macrolide treatment has proven benefit in inflammatory airways diseases , but whether it leads to changes in the composition of respiratory microbiota is unknown .
-BACKGROUND	We aimed to assess whether long-term , low-dose erythromycin treatment changes the composition of respiratory microbiota in people with non-cystic fibrosis bronchiectasis .
-METHODS	Microbiota composition was determined by 16S rRNA gene sequencing of sputum samples from participants in the BLESS trial , a 12-month , double-blind , placebo-controlled trial of twice-daily erythromycin ethylsuccinate ( 400 mg ) in adult patients with non-cystic fibrosis bronchiectasis and at least two infective exacerbations in the preceding year .
-METHODS	The primary outcome was within-patient change in respiratory microbiota composition ( assessed by Bray-Curtis index ) between baseline and week 48 , comparing erythromycin with placebo .
-METHODS	The BLESS trial is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN12608000460303 .
-RESULTS	The BLESS trial took place between Oct 15 , 2008 , and Dec 14 , 2011 .
-RESULTS	Paired sputum samples were available from 86 randomly assigned patients , 42 in the placebo group and 44 in the erythromycin group .
-RESULTS	The change in microbiota composition between baseline and week 48 was significantly greater with erythromycin than with placebo ( median Bray-Curtis score 052 [ IQR 014-078 ] vs 068 [ 046-093 ] ; median difference 016 , 95 % CI 001-033 ; p = 003 ) .
-RESULTS	In patients with baseline airway infection dominated by Pseudomonas aeruginosa , erythromycin did not change microbiota composition significantly .
-RESULTS	In those with infection dominated by organisms other than P. aeruginosa , erythromycin caused a significant change in microbiota composition ( p = 003 [ by analysis of similarity ] ) , representing a reduced relative abundance of Haemophilus influenzae ( 353 % [ 55-916 ] vs 67 % [ 08-748 ] ; median difference 126 % , 95 % CI 04-283 ; p = 004 ; interaction p = 002 ) and an increased relative abundance of P aeruginosa ( 002 % [ 000-033 ] vs 013 % [ 001-3958 ] ; median difference 66 % , 95 % CI 01-371 ; p = 0002 ; interaction p = 045 ) .
-RESULTS	Compared with placebo , erythromycin reduced the rate of pulmonary exacerbations over the 48 weeks of the study in patients with P. aeruginosa-dominated infection ( median 1 [ IQR 0-3 ] vs 3 [ 2-5 ] ; median difference -2 , 95 % CI -4 to -1 ; p = 001 ) , but not in those without P. aeruginosa-dominated infection ( 1 [ 0-2 ] vs 1 [ 0-3 ] ; median difference 0 , -1 to 0 ; p = 041 ; interaction p = 004 ) .
-CONCLUSIONS	Long-term erythromycin treatment changes the composition of respiratory microbiota in patients with bronchiectasis .
-CONCLUSIONS	In patients without P. aeruginosa airway infection , erythromycin did not significantly reduce exacerbations and promoted displacement of H. influenzae by more macrolide-tolerant pathogens including P. aeruginosa .
-CONCLUSIONS	These findings argue for a cautious approach to chronic macrolide use in patients without P. aeruginosa airway infection .
-BACKGROUND	Mater Adult Respiratory Research Trust Fund .
-
-###25277789
-OBJECTIVE	To evaluate whether a combination of misoprostol and oxytocin more effectively reduces blood loss during and after cesarean delivery than does oxytocin alone among women with known risk factors for postpartum hemorrhage ( PPH ) .
-METHODS	A prospective , randomized , double-blind , placebo-controlled trial was performed at a tertiary care center in Kolkata , India , between October 2012 and December 2013 .
-METHODS	Women were eligible if they were undergoing emergency cesarean under spinal anesthesia and were at high risk for PPH .
-METHODS	Participants were randomly assigned ( 1:1 ) to receive 400 g misoprostol or matched placebo sublingually after delivery of the newborn using a computer-generated random number sequence ( block size eight ) .
-METHODS	Participants and providers were masked to assignment .
-METHODS	All participants received 20 IU oxytocin .
-METHODS	The primary outcomes were intraoperative and postoperative blood loss .
-RESULTS	Both groups contained 198 women .
-RESULTS	Mean intraoperative blood loss was significantly lower in the misoprostol group ( 505.4215.5 mL ) than in the placebo group ( 587.3201.5 mL ; P < 0.001 ) .
-RESULTS	Mean postoperative blood loss was slightly lower in the misoprostol group ( 96.957.3 mL ) than in the placebo group ( 103.458.4 mL ; P = 0.07 ) .
-RESULTS	Shivering and pyrexia were more frequently associated with misoprostol ( P < 0.05 for both ) .
-CONCLUSIONS	Misoprostol as an adjunct to oxytocin seemed to more effectively reduce blood loss than did oxytocin alone .
-CONCLUSIONS	Clinical Trial Registry India : CTRI/2013/05 / 003645 .
-
-###24621800
-OBJECTIVE	This study aimed to assess cost-effectiveness of N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) - guided versus symptom-guided therapy in heart failure ( HF ) patients60 years old .
-BACKGROUND	Cost-effectiveness of NT-proBNP guidance in HF patients is unclear .
-BACKGROUND	It may create additional costs with uncertain benefits .
-METHODS	In the TIME-CHF ( Trial of Intensified versus Standard Medical Therapy in Elderly Patients with Congestive Heart Failure ) , patients with left ventricular ejection fraction ( LVEF ) of45 % were randomized to receive intensified NT-proBNP-guided therapy or standard , symptom-guided therapy .
-METHODS	For cost-effectiveness analysis , 467 ( 94 % ) patients ( age 76 7 years , 66 % male ) were eligible .
-METHODS	Incremental cost-effectiveness was calculated as incremental costs per gained life-year and quality-adjusted life-year ( QALY ) within the 18-month trial period , as defined per protocol .
-RESULTS	NT-proBNP-guided therapy was dominant ( i.e. , more effective and less costly ) over symptom-guided therapy , saving $ 2,979 USD ( 2.5 to 97.5 % confidence interval [ CI ] : $ 8,758 to $ 3,265 ) per patient , with incremental effectiveness of +0.07 life-years and +0.05 QALYs .
-RESULTS	The probability of NT-proBNP-guided therapy being dominant was 80 % , and the probability of saving 1 life-year or QALY at a cost of $ 50,000 was 97 % and 93 % , respectively .
-RESULTS	Exclusion of residence costs resulted in an incremental cost-effectiveness ratio ( ICER ) of $ 5,870 per life-year gained .
-RESULTS	Cost-effectiveness of NT-proBNP-guided therapy was most pronounced in patients < 75 years old and in those with < 2significant comorbidities , being dominant in all sensitivity analyses .
-RESULTS	In the worst-case scenario ( excluding residence costs in those with2 comorbidities ) , the ICER was $ 11,935 per life-year gained .
-CONCLUSIONS	NT-proBNP-guided therapy has a high probability of being cost effective in HF patients with reduced LVEF , particularly in patients age 60 to 75 years or with less than 2 comorbidities .
-CONCLUSIONS	( Trial of Intensified versus standard Medical therapy in Elderly patients with Congestive Heart Failure [ TIME-CHF ] ; ISRCTN43596477 ) .
-
-###25110231
-BACKGROUND	Functional magnetic resonance imaging ( fMRI ) studies involving alcohol challenge are important for identifying neural correlates of alcohol 's psychopharmacological effects .
-BACKGROUND	However , evaluating acute alcohol effects on blood oxygen level-dependent ( BOLD ) signal change is complicated by alcohol-related increases in cerebral blood flow ( CBF ) .
-OBJECTIVE	The present study aimed to further characterize acute alcohol effects on CBF using intravenous alcohol administration to maximize control over brain alcohol exposure .
-METHODS	Twenty heavy-drinking young adults ( M = 19.95 years old , SD = 0.76 ) completed alcohol and placebo imaging sessions in a within-subject , counter-balanced , placebo-controlled design .
-METHODS	Arterial spin labeling ( ASL ) provided estimates of perfusion change at two target blood alcohol concentrations ( 40 and 80 mg % ) relative to baseline and relative to a saline control infusion .
-RESULTS	Voxel-wise analyses showed widespread and dose-dependent effects of alcohol on CBF increase .
-RESULTS	Region-of-interest analyses confirmed these findings , also indicating regional variation in the magnitude of perfusion change .
-RESULTS	Additional findings indicated that lower self-reported sensitivity to alcohol corresponded with reduced perfusion change during alcohol administration .
-CONCLUSIONS	This study provides further evidence for widespread effects of acute alcohol on cerebral perfusion , also demonstrating regional , dose-dependent , and inter-individual variation .
-CONCLUSIONS	Further research is needed to evaluate implications of these effects for the design and interpretation of pharmacological fMRI studies involving alcohol challenge .
-
-###25098195
-METHODS	Feasibility randomized controlled trial .
-OBJECTIVE	To assess the feasibility of a trial to investigate the effectiveness of a lumbopelvic monitor as a feedback device for modifying postural behavior during daily work-related activities .
-BACKGROUND	Frequent or sustained flexed postures play a role in the development or maintenance of nonspecific low back pain .
-BACKGROUND	The provision of postural feedback could help individuals with or at risk of nonspecific low back pain improve their postural awareness and avoid hazardous or pain-provoking postures .
-METHODS	Sixty-two participants employed in a health care organization were randomly allocated into 1 of 3 groups : a control group , an intermittent feedback group , and a constant feedback group .
-METHODS	Adherence and follow-up rates were assessed .
-METHODS	Differences in postural pattern between baseline and follow-up measurements were used to assess the effectiveness of the lumbopelvic monitor as a postural feedback device .
-RESULTS	Adherence was approximately 75 % .
-RESULTS	With the exception of 1 center , the follow-up overall rates exceeded the a priori desired threshold of 80 % .
-RESULTS	Within-group comparisons revealed no significant differences in postural pattern for the control group and intermittent feedback group .
-RESULTS	The constant feedback group showed a significant reduction in flexed posture at the follow-up period compared with the baseline period .
-RESULTS	Differences between groups did not reach statistical significance ; however , the constant feedback group , compared with the control group , demonstrated an effect size ( d ) of 0.60 .
-CONCLUSIONS	The provision of constant postural feedback seems promising for promoting changes in postural behavior .
-CONCLUSIONS	This feasibility trial identified adherence and follow-up rates and sample-size estimates important to the conduct of a fully powered efficacy trial .
-CONCLUSIONS	Level of Evidence Therapy , level 2b - .
-
-###25271117
-OBJECTIVE	To evaluate basal and prandial insulin initiation and titration in people with type 2 diabetes mellitus ( T2DM ) in primary care and to explore the feasibility of retrospective-continuous glucose monitoring ( r-CGM ) in guiding insulin dosing .
-OBJECTIVE	The new model of care features General Practitioners ( GPs ) and Practice Nurses ( PNs ) working in an expanded role , with Credentialed Diabetes Educator - Registered Nurse ( CDE-RN ) support .
-METHODS	Insulin-nave T2DM patients ( HbA1c > 7.5 % [ > 58 mmol/mol ] despite maximal oral therapy ) from 22 general practices in Victoria , Australia commenced insulin glargine , with glulisine added as required .
-METHODS	Each was randomised to receive r-CGM or self-monitoring of blood glucose ( SMBG ) .
-METHODS	Glycaemic control ( HbA1c ) was benchmarked against specialist ambulatory patients referred for insulin initiation .
-RESULTS	Ninety-two patients mean age ( range ) 59 ( 28-77 ) years ; 40 % female ; mean ( SD ) diabetes duration 10.5 ( 6.1 ) years participated .
-RESULTS	HbA1c decreased from ( median ( IQR ) ) 9.9 ( 8.8 , 11.2 ) % ; 85 ( 73 , 99 ) mmol/mol to 7.3 ( 6.9 , 7.8 ) % ; 56 ( 52 , 62 ) mmol/mol at 24 weeks ( p < 0.0001 ) .
-RESULTS	Comparing r-CGM ( n = 46 ) with SMBG ( n = 42 ) , there were no differences in major hypoglycaemia ( p = 0.17 ) or HbA1c ( p = 0.31 ) .
-RESULTS	More r-CGM than SMBG participants commenced glulisine ( 26/48 vs. 7/44 ; p < 0.001 ) .
-RESULTS	Results were comparable to 82 benchmark patients , with similar low rates of major hypoglycaemia ( 2/89 vs. 0/82 ; p = 0.17 ) and less loss to follow up in the INITIATION group ( 3/92 vs. 14/82 ; p = 0.002 ) .
-CONCLUSIONS	Insulin initiation and titration for T2DM patients in primary care was safe and improved HbA1c with low rates of major hypoglycaemia .
-CONCLUSIONS	CDE-RNs were effective in a new consultant role .
-CONCLUSIONS	r-CGM use in primary care was feasible and enhanced post-prandial hyperglycaemia recognition .
-CONCLUSIONS	Trial registration ACTRN12610000797077 .
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-###25006854
-BACKGROUND	Platelet-rich plasma ( PRP ) is an autologous preparation of platelets in concentrated plasma that may be beneficial in the treatment of atrophic acne scars by promoting collagen deposition .
-BACKGROUND	Skin needling is a technique that uses a sterile dermaroller to puncture the skin and release growth factors .
-BACKGROUND	The combination of skin needling and PRP could enhance the efficacy of both modalities .
-BACKGROUND	Chemical reconstruction of skin scars technique consists of focal application of high concentration of trichloroacetic acid ( TCA ) on the acne scars to stimulate collagen production .
-OBJECTIVE	To evaluate the efficacy and safety of intradermal injection of PRP , 100 % focal TCA , and combined skin needling plus topical PRP in the treatment of atrophic acne scars .
-METHODS	Forty-five patients with atrophic acne scars were randomly assigned to 3 equal groups ; Group A received intradermal injection of PRP , Group B received chemical reconstruction of skin scars technique with TCA 100 % , and Group C was treated by combined skin needling and PRP .
-METHODS	Each patient underwent 3 sessions at 2-week interval .
-RESULTS	All the patients completed the study .
-RESULTS	The 3 groups showed statistically highly significant improvement in the degree of acne scars after treatment ( p < .001 ) .
-RESULTS	No major adverse effects were observed in the studied groups .
-CONCLUSIONS	This is the first study to use intradermal injection of PRP alone for the treatment of atrophic acne scars .
-CONCLUSIONS	The 3 modalities showed a promising efficacy and safety in the treatment of atrophic acne scars .
-
-###25704790
-BACKGROUND	While the addition of targeted therapy to neoadjuvant chemotherapy ( NACT ) dramatically increases the rate of pathological complete response in HER2-positive breast cancer , no reduction in the rate of mastectomy has been observed in randomised studies .
-METHODS	A retrospective single centre analysis of all patients treated with anti HER2-based NACT for T2-4 breast cancer , focusing on patients treated with mastectomy .
-RESULTS	Among 165 patients treated between June 2005 and July 2012 , surgery was performed immediately post-NACT in 152 cases ( 92 % ) .
-RESULTS	Breast-conserving surgery could be performed for 108 of the patients ( 71 % ) , with a 4-year local relapse-free survival of 97 % .
-RESULTS	A mastectomy was performed in two cases following patients ' wishes and in 37 cases based on pre-NACT findings ( n = 18 ) or post-NACT outcomes ( n = 19 ) .
-RESULTS	For 21 out of the 37 cases , a good pathological response was observed , and multidisciplinary reanalysis suggests that breast-conserving surgery outright may have been sufficient for 12 patients .
-RESULTS	Finally , a salvage mastectomy based on post-lumpectomy pathological results was decided in five cases ( 11 % ) .
-RESULTS	The 4-year metastasis-free survival was 84 % for all patients operated on after NACT ( n = 152 ) .
-CONCLUSIONS	Given the good efficacy of anti HER2-based NACT , breast-conserving surgery should be standard practice for most patients .
-CONCLUSIONS	Total mastectomy on the other hand should be restricted to a few patients , mainly those with positive margins on the lumpectomy specimen .
-
-###24973609
-OBJECTIVE	To investigate the 20-year efficacy and safety of photorefractive keratectomy ( PRK ) .
-METHODS	Long-term observational case series .
-METHODS	In the setting of a university hospital , a study population of 42 patients ( 42 eyes ) who had , as part of a randomized prospective trial , undergone PRK 20 years previously were studied .
-METHODS	All had received -3.0 or -6.0 diopter ( D ) corrections with either 5.0 or 6.0 mm optical zones or a multizone treatment .
-METHODS	The mean preoperative spherical equivalent refractive error ( SEQ ) was -5.13 D ( range , -2.75 to -8.0 D ) .
-METHODS	The outcome measures included visual acuity , refractive error , corneal topography and axial length .
-RESULTS	Between 1 and 20 years there was an increase in mean myopic SEQ of -0.54 D ( P < 0.02 ) .
-RESULTS	In patients younger than 40 years of age at time of correction , this increase was -0.92 D ( P < 0.002 ) with an accompanying increase in variance ( P < 0.02 ) , whereas in those older than 40 it was -0.08 D ( P = 0.8 ) .
-RESULTS	In female patients the change was -0.69 D ( P < 0.01 ) , while in males it was -0.26 D ( P = 0.6 ) .
-RESULTS	The efficacy index at 20 years was 0.49 , and the safety index was 0.97 .
-RESULTS	Corrected distance visual acuity improved between 1 and 20 years ( P < 0.01 ) ; 93 % of corneas were clear at 20 years ; 3 eyes had trace haze .
-RESULTS	There was an improvement in haze scores between 1 and 20 years ( P < 0.02 ) .
-RESULTS	Cornea power remained unchanged between 6 months and 20 years ( P = 0.4 ) .
-RESULTS	Axial length increased by a mean of 0.84 mm ( P < 0.0001 ) .
-RESULTS	There was no ectasia .
-CONCLUSIONS	There was a slight but significant increase in myopic SEQ after PRK between 1 and 20 years , particularly in those under 40 at the time of treatment and in female patients .
-CONCLUSIONS	Corneal power remained unchanged , but axial length increased .
-CONCLUSIONS	The procedure was safe , with no long-term sight-threatening complications and with improvements in corrected distance visual acuity and corneal transparency with time .
-
-###24275838
-OBJECTIVE	We investigated data in 373 patients from the EXPLOR trial to determine the influence of heart rate ( HR ) and blood pressure ( BP ) on aortic stiffness in response to beta-blockade or angiotensin 2 type 1 receptor antagonism , administered during 24 weeks .
-METHODS	Carotid-femoral pulse wave velocity ( PWV ) was measured with aplanation tonometry ( Sphygmocor ) after 8 ( W8 ) and 24 weeks ( W24 ) of treatment by the single-pill combination valsartan-amlodipine ( 80/5 mg , then 160/10 mg ) or an atenolol-amlodipine combination ( 50/5 mg , then 100/10 mg ) in a prospective , randomized , parallel-groups multicenter trial with PROBE design .
-METHODS	Drugs were up-titrated at W8 .
-METHODS	We analyzed the changes in PWV in relation with the changes in BP and HR , and major covariates , using mixed models in each treatment arm .
-RESULTS	The unadjusted reductions in mean BP and PWV were not significantly different between groups .
-RESULTS	HR was significantly reduced in the atenolol group , but not in the valsartan group .
-RESULTS	After adjustment on BP and HR , PWV significantly decreased with valsartan [ -0.37 m/s ( -0.70 to -0.08 ) at W8 and -0.43 ( -0.76 to -0.10 ) m/s at W24 ] , whereas no significant change was observed after atenolol [ -0.16 m/s ( -0.49 to 0.17 ) at W8 and -0.05 ( -0.35 to 0.44 ) m/s at W24 ] .
-CONCLUSIONS	These findings suggest that the reduction in PWV observed after atenolol could be explained by changes in BP and HR , whereas in patients treated by valsartan , about half of the decrease in aortic stiffness was BP-independent .
-
-###24837447
-OBJECTIVE	To evaluate the efficacy of daily low-dose sildenafil for the treatment of nonulcer interstitial cystitis ( IC ) in women .
-METHODS	Forty-eight women with a clinical diagnosis of IC from 3 medical centers were randomly assigned to treatment with daily low-dose sildenafil ( 25 mg , n = 24 ) or placebo ( n = 24 ) for 3 months .
-METHODS	The O'Leary-Sant IC symptom and problem indices , visual analog scale scores , and a micturition diary with the interval of micturition , the frequency of nocturia , and urgency episodes were recorded before treatment , every 2 weeks after the treatment until 3 months .
-METHODS	Patient Overall Rating of Improvement in Symptoms was assessed and regarded as effective when the value was above 50 % .
-RESULTS	The IC symptom and problem indices scores and urodynamic index were significantly improved in sildenafil treatment group as compared with placebo group and baselines at week 4 , 6 , 8 , 10 , and 12 , as well as 3 months after treatment ( P < .05 ) .
-RESULTS	Urodynamic index including first desire to void , strong desire to void , and maximum cystometric capacity was significantly improved in sildenafil treatment group at week 12 and at 3 months after treatment ( P < .05 ) .
-RESULTS	The efficiency of treatment reached 62.5 % .
-RESULTS	However , no significant change of the visual analog scale values was observed between 2 groups except at week 12 in the sildenafil treatment group ( P < .05 ) .
-RESULTS	All adverse events were mild to moderate and transient .
-CONCLUSIONS	Daily low-dose sildenafil is an easy , well-tolerated , and effective treatment for IC in women .
-
-###25620452
-OBJECTIVE	Girls in the child welfare system are at high risk of revictimization in adolescence .
-OBJECTIVE	The present study compared two interventions designed to decrease revictimization in a diverse sample of adolescent child welfare-involved girls .
-OBJECTIVE	The social learning/feminist ( SL/F ) intervention focused on concepts derived from social learning and feminist models of risk , such as sexism and beliefs about relationships .
-OBJECTIVE	The risk detection/executive function ( RD/EF ) intervention focused on development of specific executive function abilities related to detecting and responding to risky situations/people .
-METHODS	Participants were randomized to RD/EF ( n = 67 ) or SL/F intervention ( n = 67 ) .
-METHODS	A group of youth ( n = 42 ) engaged in the research assessments only .
-METHODS	Participants ( n = 180 ) were assessed before intervention , immediately after intervention , 2 months after intervention , and 6 months after intervention .
-METHODS	We examined revictimization ( the presence/absence of sexual or physical assault in any relationship ) over time .
-RESULTS	Adolescent girls in the RD/EF condition were nearly five times less likely to report sexual revictimization compared with girls in the no-treatment group .
-RESULTS	A trend suggested that girls who participated in the SL/F intervention were 2.5 times less likely to report sexual revictimization relative to the no-treatment group .
-RESULTS	For physical revictimization , the odds of not being physically revictimized were three times greater in the SL/F condition and two times greater in the RD/EF condition compared with the no-treatment group .
-CONCLUSIONS	The active interventions did not differ significantly from one another in rates of revictimization , suggesting that practitioners have at least two viable options to engage high-risk youth in revictimization prevention .
-
-###24760248
-OBJECTIVE	To investigate whether magnesium oxide reduces the interfraction motion of the prostate and the amount of rectal filling and rectal gas , which influences prostate position during radiotherapy for prostate cancer .
-METHODS	From December 2008 to February 2010 , 92 prostate cancer patients scheduled for intensity-modulated radiotherapy ( 77 Gy in 35 fractions ) using fiducial marker-based position verification were randomly assigned to receive magnesium oxide ( 500 mg twice a day ) or placebo during radiotherapy .
-METHODS	In a previous study , we investigated the effect on intrafraction motion and did not find a difference between the treatment arms .
-METHODS	Here , we compared the interfraction prostate motion between the two treatment arms as well as the amount of rectal filling and rectal air pockets using pretreatment planning computed tomography and magnetic resonance imagingscans .
-RESULTS	There was no statistically significant difference between the treatment arms in translation and rotation of the prostate between treatment fractions , except for the rotation around the cranial caudal axis .
-RESULTS	However , the difference was less than 1 and therefore considered not clinically relevant .
-RESULTS	There was no significant difference in the amount of rectal filling and rectal air pockets between the treatment arms .
-CONCLUSIONS	Magnesium oxide is not effective in reducing the interfraction prostate motion or the amount of rectal filling and rectal gas during external-beam radiotherapy .
-CONCLUSIONS	Therefore , magnesium oxide is not recommended in clinical practice for these purposes .
-
-###24597620
-BACKGROUND	The primary aim of rheumatoid arthritis ( RA ) treatment is to induce remission , the absence of disease activity .
-BACKGROUND	The objective of this study was to explore the association between clinical endpoints used to gauge RA treatment efficacy and patient-reported outcomes of health-related quality of life , fatigue , and physical function in RA patients treated with secukinumab in a phase 2 randomized controlled trial ( RCT ) .
-METHODS	Adult RA patients ( n = 237 ) with incomplete responses to methotrexate were randomized equally to receive monthly s.c. injections of secukinumab 25mg , 75mg , 150mg , 300mg or placebo .
-METHODS	Clinical endpoints used in this study included the ACR response criteria and its components and simplified disease activity score .
-METHODS	Patient-reported outcomes ( PRO ) included Health Assessment Questionnaire-Disability Index ( HAQ-DI ) , Medical Outcomes Study Short Form-36 [ SF-36 ] Survey , and Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-Fatigue ) .
-METHODS	Patients were categorized into mutually exclusive groups according to the magnitude and direction of change from baseline to week 16 in each clinical endpoint .
-METHODS	Definitions of minimal important differences [ MID ] in each clinical endpoint were used to categorize patients , as well as thresholds beyond MID .
-METHODS	Mean changes from baseline to week 16 were computed for each PRO and analyses of variance to test the differences in PRO changes observed across groups of patients that differed in each clinical endpoint .
-METHODS	Analyses were limited to patients randomized to secukinumab treatment .
-METHODS	All dose groups were combined ( n = 187 ) .
-RESULTS	Mean changes from baseline in each PRO differed significantly across groups of patients in the expected direction .
-RESULTS	With few exceptions , there was considerable agreement between clinical endpoints and PROs concerning the magnitude of change defined as clinically meaningful .
-RESULTS	More importantly , results demonstrated that greater improvements in clinical endpoints were associated with incrementally better improvements in HRQoL , fatigue , and physical function .
-CONCLUSIONS	Results of this study show considerable agreement between minimal thresholds of improvement established for PROs and clinical outcome measures used in RA treatment studies and provide thresholds to be considered in gauging the importance of a treatment effect that goes beyond what is considered as minimally important for PRO measures .
-
-###24438500
-BACKGROUND	Computed tomography is widely used to diagnose acute appendicitis .
-BACKGROUND	Many adolescents and young adults are exposed to the associated radiation .
-BACKGROUND	A recent single-institution trial has reported promising results for low-dose computed tomography ; however , this technique has not yet been widely adopted .
-BACKGROUND	LOCAT ( low-dose computed tomography for appendicitis trial ) , a multi-institution randomized controlled non-inferiority trial , aims to compare low-dose computed tomography and standard-dose computed tomography as the first-line imaging tests for adolescents and young adults , and therefore to test the generalizability of the previous single-institution trial results .
-METHODS	Participants with suspected appendicitis are randomly assigned to either the low-dose group ( with a typical effective dose of 2mSv ) or the standard-dose group ( as used in normal practice at each participating site , typically 8mSv ) .
-METHODS	The primary end point is the negative appendectomy rate ( the percentage of the number of uninflamed appendices that were removed among all non-incidental appendectomies ) , which is a consequence of false-positive diagnoses , with a non-inferiority margin of 4.5 percentage points .
-METHODS	The key secondary end point is the appendiceal perforation rate , which is a consequence of delayed ( or false-negative ) diagnoses .
-METHODS	Participant recruitment will be continued until the number of non-incidental appendectomies for each group exceeds 444 .
-METHODS	The total number of expected participants approximates 3,000 , including those not undergoing appendectomy .
-CONCLUSIONS	In addition to the study protocol , we elaborate on several challenging or potentially debatable components of the study design , including the broad eligibility criteria , choice of the primary end point , potential effect of using advanced imaging techniques on study results , determining and adjusting the radiation doses , ambiguities in reference standards , rationale for the non-inferiority margin , use of the intention-to-treat approach and difficulties in defining adverse events .
-BACKGROUND	ClinicalTrials.gov NCT01925014 .
-
-###25438937
-OBJECTIVE	Vitamin D insufficiency has been associated with impaired pancreatic beta-cell function .
-OBJECTIVE	We aimed to determine if high dose oral vitamin D3 ( D ) improves beta-cell function and glycaemia in type 2 diabetes .
-METHODS	Fifty adults with type 2 diabetes diagnosed less than 12 months , with normal baseline serum 25-OH D ( 25D ) , were randomised to 6000 IU D ( n = 26 ) or placebo ( n = 24 ) daily for 6 months .
-METHODS	Beta-cell function was measured by glucagon-stimulated serum C-peptide ( delta C-peptide [ DCP ] , nmol/l ) .
-METHODS	Secondary outcome measures were fasting plasma glucose ( FPG ) , post-prandial blood glucose ( PPG ) , HbA1c and insulin resistance ( HOMA-IR ) .
-RESULTS	In the D group , median serum 25D ( nmol/l ) increased from 59 to 150 ( 3 months ) and 128 ( 6 months ) and median serum 1,25 D ( pmol/l ) from 135 to 200 and 190 .
-RESULTS	After 3 months , change in DCP from baseline in D ( +0.04 ) and placebo ( -0.08 ) was not different ( P = 0.112 ) .
-RESULTS	However , change in FPG ( mmol/l ) was significantly lower in D ( -0.40 ) compared to placebo ( +0.1 ) ( P = 0.007 ) , as was the change in PPG in D ( -0.30 ) compared to placebo ( +0.8 ) ( P = 0.005 ) .
-RESULTS	Change in HbA1c ( % ) between D ( -0.20 ) and placebo ( -0.10 ) was not different ( P = 0.459 ) .
-RESULTS	At 6 months , changes from baseline in DCP , FPG , PPG and HbA1c were not different between groups .
-CONCLUSIONS	Oral D3 supplementation in type 2 diabetes was associated with transient improvement in glycaemia , but without a measurable change in beta-cell function this effect is unlikely to be biologically significant .
-CONCLUSIONS	High dose D3 therefore appears to offer little or no therapeutic benefit in type 2 diabetes .
-
-###24630881
-OBJECTIVE	This study sought to evaluate the short - and long-term outcomes for smokers with non-ST-segment elevation acute coronary syndromes ( NSTE-ACS ) .
-BACKGROUND	Smoking has been associated with the `` paradox '' of reduced mortality after acute myocardial infarction ( MI ) .
-BACKGROUND	This is thought to be due to favorable baseline characteristics and less diffuse coronary artery disease ( CAD ) among smokers .
-METHODS	In the ACUITY ( Acute Catheterization and Urgent Intervention Triage Strategy ) trial , 13,819 patients ( 29.1 % smokers ) with moderate - to high-risk NSTE-ACS underwent angiography and , if indicated , revascularization .
-RESULTS	Smokers were significantly younger and had fewer comorbidities than nonsmokers .
-RESULTS	Incidence of death and MI were comparable at 30 days , although smokers had significantly reduced risks of 30-day major bleeding ( hazard ratio [ HR ] : 0.80 , 95 % confidence interval [ CI ] : 0.67 to 0.96 ; p = 0.016 ) and 1-year mortality ( HR : 0.797 , 95 % CI : 0.65 to 0.97 ; p = 0.027 ) .
-RESULTS	After correction for baseline and clinical differences , smoking was no longer predictive of major bleeding ( odds ratio : 1.06 , 95 % CI : 0.86 to 1.32 ; p = 0.56 ) and was associated with higher 1-year mortality ( HR : 1.37 , 95 % CI : 1.07 to 1.7 ; p = 0.013 ) .
-RESULTS	This pattern of reversed risk after multivariable correction held true for those smokers requiring percutaneous coronary intervention .
-RESULTS	Core laboratory angiographic analysis showed that smokers and nonsmokers were comparable in terms of the extent of CAD , Thrombolysis In Myocardial Infarction flow , myocardial blush , and the presence of thrombi .
-CONCLUSIONS	In contrast to the paradox previously described in ST-segment elevation MI , our analysis finds smoking to be an independent predictor of higher 1-year mortality in patients presenting with NSTE-ACS , and our angiographic study demonstrates CAD in smokers that is comparable to that in nonsmokers but evident 1 decade earlier .
-CONCLUSIONS	( Acute Catheterization and Urgent Intervention Triage Strategy [ ACUITY ] ; NCT00093158 ) .
-
-###25216464
-BACKGROUND	Despite empirical evidence demonstrating the effectiveness of collaborative stepped care program ( SCP ) in Western countries , such programs have not been evaluated in the east , which has a different services system structure and cultural nuances in seeking help for mental illness .
-BACKGROUND	Furthermore , only a few studies have used SCP for depression and anxiety prevention .
-BACKGROUND	We conducted a trial to test its effectiveness in preventing major depressive disorder and generalized anxiety disorder among primary care patients with subthreshold depression and/or anxiety in Hong Kong .
-METHODS	Subthreshold depression and/or anxiety patients were randomized into the SCP group ( n = 121 ) or care as usual ( CAU ) group ( n = 119 ) .
-METHODS	The SCP included watchful waiting , telephone counseling , problem solving therapy , and family doctor treatment within one year .
-METHODS	The primary outcome was the onset of major depressive disorder or generalized anxiety disorder in 15 months .
-METHODS	The secondary outcomes were depressive and anxiety symptoms , quality of life and time absent from work due to any illness .
-RESULTS	Survival analysis showed no differences between the SCP and CAU groups ( the cumulative probability of onset at 15 month was 23.1 % in the SCP group and 20.5 % in the CAU group ; Hazard Ratio = 1.62 ; 95 % Confidence Interval : 0.82-3 .18 ; p = 0.16 ) .
-RESULTS	No significant differences were found in secondary outcomes .
-CONCLUSIONS	Sample size might not have been large enough .
-CONCLUSIONS	SCP did not show beneficial effect on depression/anxiety prevention compared with CAU in Hong Kong primary care .
-CONCLUSIONS	As a large majority of patients improved overtime without any intervention , we are not able to exclude the possibility that the intervention might be effective .
-CONCLUSIONS	Future studies would need to have a larger sample size and conduct on patients with more severe symptoms or perform a second screening .
-
-###24341963
-OBJECTIVE	Compare the impact of two interventions , a web-based support and a folder support , for young persons who care for people who suffer from mental illness .
-METHODS	This study was a randomized control trial , following the CONSORT statements , which compared the impact of two interventions .
-METHODS	Primary outcome variable was stress , and secondary outcome variables were caring situation , general self-efficacy , well-being , health , and quality of life of young informal carers ( N = 241 ) .
-METHODS	Data were collected in June 2010 to April 2011 , with self-assessment questionnaires , comparing the two interventions and also to detect changes .
-RESULTS	The stress levels were high in both groups at baseline , but decreased in the folder group .
-RESULTS	The folder group had improvement in their caring situation ( also different from the web group ) , general self-efficacy , well-being , and quality of life .
-RESULTS	The web group showed increase in well-being .
-CONCLUSIONS	Young informal carers who take on the responsibility for people close to them ; suffer consequences on their own health .
-CONCLUSIONS	They live in a life-situation characterized by high stress and low well-being .
-CONCLUSIONS	This signals a need for support .
-CONCLUSIONS	The non-significant differences show that each intervention can be effective , and that it depends upon the individual 's preferences .
-CONCLUSIONS	This highlights the importance of adopting person-centered approach , in which young persons can themselves choose support strategy .
-
-###25127210
-BACKGROUND	Hydroxyethyl starch ( HES ) is commonly used as plasma expander during surgery but may be nephrotoxic as seen in studies in patients with sepsis .
-BACKGROUND	The authors hypothesized that the possible nephrotoxicity of 6 % HES 130/0 .4 could be revealed by measurements of urinary excretion of neutrophil gelatinase-associated lipocalin ( u-NGAL ) in patients with normal renal function during hip arthroplasty .
-METHODS	In this randomized , double-blinded , placebo-controlled study , 40 patients referred for hip arthroplasty received either 6 % HES 130/0 .4 or isotonic saline 0.9 % ; 7.5 ml/kg during the first hour of surgery and 5 ml/kg during the following hours ; 38 patients completed the study .
-METHODS	U-NGAL , urine albumin , blood pressure , and plasma concentrations of creatinine , renin , NGAL , albumin , angiotensin-II , and aldosterone were measured before , during , and after surgery .
-METHODS	U-NGAL was defined as primary outcome .
-RESULTS	There were no significant differences in U-NGAL ( mean difference and 95 % CI ) , plasma creatinine , and urine albumin during the study .
-RESULTS	U-NGAL and urine albumin increased significantly in both groups the morning after surgery but was normalized at follow-up after 10 to 12 days .
-RESULTS	Mean arterial pressure was significantly higher during the recovery period in the HES group compared with that in the control group ( 91 [ 13 ] and 83 [ 6 ] mmHg , mean [ SD ] , P < 0.03 ) .
-RESULTS	Plasma renin and angiotensin-II were nonsignificantly different in both groups , whereas plasma aldosterone was significantly lower in the HES group .
-RESULTS	Plasma albumin was reduced in both groups , but to a significantly lower level in the HES group .
-CONCLUSIONS	The study showed no evidence of a harmful effect of intraoperative infusion of 6 % HES 130/0 .4 on renal function in patients during hip arthroplasty .
-
-###25633037
-BACKGROUND	We performed a multicentre randomised controlled trial to evaluate the effect on participation in organised screening programmes of a self-sampling device mailed home or picked up at a pharmacy compared with the standard recall letter .
-METHODS	Women aged 30-64 non-responding to screening invitation were eligible .
-METHODS	Response rate to first invitation ranged from 30 % to 60 % between centres .
-METHODS	The control was the standard reminder letter to undergo the test used by the programme ( Pap test in three centres and HPV DNA test in three other centres ) .
-METHODS	Home mailing of the self-sampler was preceded by a letter with a leaflet about HPV .
-METHODS	The analysis was intention-to-treat .
-RESULTS	In all , 14041 women were randomised and recruited : 5012 in the control arm , 4516 to receive the self-sampler at home , and 4513 to pick up the self-sampler at a pharmacy .
-RESULTS	Participation was 11.9 % in the control , 21.6 % ( relative participation : 1.75 ; 95 % CI 1.60-1 .93 ) in home , and 12.0 % ( relative participation : 0.96 ; 95 % CI 0.86-1 .07 ) in the pharmacy arms , respectively .
-RESULTS	The heterogeneity between centres was high ( excess heterogeneity of that expected due to chance , i.e. , I ( 2 ) , 94.9 % and 94.1 % for home and pharmacy arm , respectively ) .
-RESULTS	The estimated impact on the overall coverage was +4.3 % for home mail self-sampling compared with +2.2 % for standard reminder .
-CONCLUSIONS	Home mailing of self-sampler proved to be an effective way to increase participation in screening programmes , even in those with HPV as primary testing .
-CONCLUSIONS	Picking up at pharmacies showed effects varying from centre to centre .
-
-###24738933
-OBJECTIVE	Excessive menstrual bleeding , the most common complication caused by intrauterine devices ( IUDs ) , often leads to discontinuation of use .
-OBJECTIVE	Our study investigates the effect of vitamin B1 on menstrual bleeding and spotting after insertion of the TCu380A IUD .
-METHODS	This double-blind , randomised controlled trial involved 110 Iranian women .
-METHODS	We recruited women who noted that their menstrual flow ( duration , amount , and number of sanitary pads needed ) or intermenstrual spotting had increased one month after the insertion of a TCu380A , and randomly assigned them to two groups .
-METHODS	The intervention group and the control group received 100 mg of vitamin B1 or a placebo , respectively , daily , for three months .
-METHODS	We followed all participants for four months .
-METHODS	The Higham scale was used for estimating the volume of menstrual bleeding .
-METHODS	The Mann-Whitney test , paired t-test , independent t-test and Repeated Measure test were used for statistical purposes .
-RESULTS	In the intervention group the duration of menstrual bleeding , the number of sanitary pads and the amount of spotting decreased significantly compared to the control group ( p < 0.001 ) .
-CONCLUSIONS	Vitamin B1 is a safe , natural and cost-effective supplement that is devoid of side effects and reduces menstrual bleeding and spotting caused by a copper bearing-IUD .
-
-###25739829
-OBJECTIVE	The RITUXVAS trial reported similar remission induction rates and safety between rituximab and cyclophosphamide based regimens for antineutrophil cytoplasm antibody ( ANCA ) - associated vasculitis at 12months ; however , immunosuppression maintenance requirements and longer-term outcomes after rituximab in ANCA-associated renal vasculitis are unknown .
-METHODS	Forty-four patients with newly diagnosed ANCA-associated vasculitis and renal involvement were randomised , 3:1 , to glucocorticoids plus either rituximab ( 375mg/m ( 2 ) / week4 ) with two intravenous cyclophosphamide pulses ( n = 33 , rituximab group ) , or intravenous cyclophosphamide for 3-6months followed by azathioprine ( n = 11 , control group ) .
-RESULTS	The primary end point at 24months was a composite of death , end-stage renal disease and relapse , which occurred in 14/33 in the rituximab group ( 42 % ) and 4/11 in the control group ( 36 % ) ( p = 1.00 ) .
-RESULTS	After remission induction treatment all patients in the rituximab group achieved complete B cell depletion and during subsequent follow-up , 23/33 ( 70 % ) had B cell return .
-RESULTS	Relapses occurred in seven in the rituximab group ( 21 % ) and two in the control group ( 18 % ) ( p = 1.00 ) .
-RESULTS	All relapses in the rituximab group occurred after B cell return .
-CONCLUSIONS	At 24months , rates of the composite outcome of death , end-stage renal disease and relapse did not differ between groups .
-CONCLUSIONS	In the rituximab group , B cell return was associated with relapse .
-BACKGROUND	ISRCTN28528813 .
-
-###24665578
-OBJECTIVE	Physical activity is a common stimulus of asthmatic symptoms manifestation .
-OBJECTIVE	Airway hyperreactivity is a predisposing cause of exercise induced bronchial obstruction , diagnosed by histamine inhalation .
-OBJECTIVE	The aim of this study was to determine the relation between the amounts of histamine needed to induce non-specific airway hyperreactivity and exercise-induced bronchial obstruction .
-METHODS	This randomized cross-over study included 160 male patients ( age 19-27 years ) suffering from bronchial asthma who showed positive results as the reaction after the histamine bronchial provocation test .
-METHODS	Histamine concentrations were in a range of 0.03 to 4 mg/mL .
-METHODS	Each patient participated in the exercise stress test conducted on a conveyor belt .
-METHODS	The results of the exercise stress test were considered positive if the FEV1 level dropped by at least 15 % from its initial value , 5-10 minutes after the test .
-RESULTS	All the patients showed positive results as the reaction after the histamine bronchial provocation test , while 50 of them showed positive results after the exercise-induced stress test .
-RESULTS	There was a statistically highly significant difference in administrated histamine concentrations between the group of patients that had positive results on exercise stress test and those who did not ( 1 mg/mL vs 0.5 mg/mL ; U = 1678 ; p < 0.01 ) .
-RESULTS	Also , there was a statistically significant difference concerning the frequency of the positive results regarding histamine concentration after induced stress test ( chi2 = 10.885 ; p = 0.001 ) .
-RESULTS	Among the patients with positive results , there was a statistically highly significant number of patients with bronchial obstruction induced by less than 2 mg/mL of histamine ( p < 0.01 ) .
-RESULTS	A statistically significant relation between the amount of histamine needed to induce bronchial obstruction and the results of the exercise stress test ( p < 0.01 ) was also observed after the testing .
-CONCLUSIONS	In the group of patients with positive results after the exercise-induced stress test , there were significantly more patients with positive results to non-specific bronchial provocation test with lower histamine concentrations .
-CONCLUSIONS	Histamine concentrations needed to induce non-specific hyperreactivity of asthmatic airway were shown to be related to the reactivity to physical effort .
-
-###25937378
-OBJECTIVE	The question of whether the placement of the dominant hand against the sternum could improve the quality of manual chest compressions remains controversial .
-OBJECTIVE	In the present study , we evaluated the influence of dominant vs nondominant hand positioning on the quality of conventional cardiopulmonary resuscitation ( CPR ) during prolonged basic life support ( BLS ) by rescuers who performed optimal and suboptimal compressions .
-METHODS	Six months after completing a standard BLS training course , 101 medical students were instructed to perform adult single-rescuer BLS for 8 minutes on a manikin with a randomized hand position .
-METHODS	Twenty-four hours later , the students placed the opposite hand in contact with the sternum while performing CPR .
-METHODS	Those with an average compression depth of less than 50 mm were considered suboptimal .
-RESULTS	Participants who had performed suboptimal compressions were significantly shorter ( 170.2 6.8 vs 174.0 5.6 cm , P = .008 ) and lighter ( 58.9 7.6 vs 66.9 9.6 kg , P < .001 ) than those who performed optimal compressions .
-RESULTS	No significant differences in CPR quality were observed between dominant and nondominant hand placements for these who had an average compression depth of greater than 50 mm .
-RESULTS	However , both the compression depth ( 49.7 4.2 vs 46.5 4.1 mm , P = .003 ) and proportion of chest compressions with an appropriate depth ( 47.6 % 27.8 % vs 28.0 % 23.4 % , P = .006 ) were remarkably higher when compressing the chest with the dominant hand against the sternum for those who performed suboptimal CPR .
-CONCLUSIONS	Chest compression quality significantly improved when the dominant hand was placed against the sternum for those who performed suboptimal compressions during conventional CPR .
-
-###25745751
-OBJECTIVE	To investigate whether cabergoline ( Cb2 ) , a dopamine agonist , reduces ovarian hyperstimulation syndrome ( OHSS ) in high-risk women undergoing assisted reproductive technology ( ART ) , and to analyze whether cabergoline affects the outcome of ART .
-METHODS	Forty infertile women at risk of developing OHSS were enrolled in the trial .
-METHODS	The inclusion criteria were as follows : infertile women undergoing IVF with serum estradiol concentration > 4,000 pg/mL or with > 20 follicles > 12 mm on the day of human chorionic gonadotropin ( hCG ) administration , and 18-40 years of age .
-METHODS	They were randomized into 2 groups : the Cb2 group ( n = 20 ) received 0.5 mg oral Cb2 per day for 8 consecutive days beginning on the day of hCG , and the control group ( n = 20 ) received no medication .
-RESULTS	Ascites was significantly lower ( p = 0.008 ) in the Cb2 group as compared with the control group .
-RESULTS	The incidence of moderate OHSS was also significantly lower ( p = 0.04 ) in the Cb2 as compared to the control group .
-RESULTS	There was no evidence of statistically significant differences regarding the parameters of ART outcome .
-CONCLUSIONS	Our data supports the use of Cb2 in the management of high-risk women undergoing ART and , consequently , achieving lowered risk of OHSS , with no deleterious impact on ART outcomes .
-
-###24625519
-OBJECTIVE	The use of peripherally inserted central venous catheters ( PICC lines ) has reduced the mortality and morbidity of premature newborns .
-OBJECTIVE	The usual sites of insertion are the veins in the upper arms but other locations are being used as well .
-METHODS	To examine whether using the axillary vein as a site of insertion of a PICC line affects the frequency of complications .
-METHODS	Our study has a clinical trial design .
-METHODS	A total of 62 neonates that had a PICC line inserted were recruited and randomly divided equally in two groups : in Group A ( mean birth weight , standard deviation ( s.d. ) = 1353 ( 142 ) g ) , the PICC line was inserted through the axillary vein , and in Group B ( birth weight = 1308 ( 112 ) g ) , the PICC line was inserted in other sites further from the axillary vein .
-METHODS	The outcomes measured were the total PICC line-related complications , the reason for removing the catheter , the number of total attempts until successful insertion and the mean duration of stay of the catheter .
-METHODS	The likelihood of having an adverse outcome was assessed with Mantel-Haenszel odds ratio ( OR ) .
-RESULTS	Premature neonates with axillary PICC lines were 12 times less likely to have line-related complications ( inflammation , blockage , edema , infection ) as compared with any other site of insertion ( OR = 95 % , confidence interval ( CI ) = 0.10 ( 0.01 to 0.8 ) ) and they were seven times more likely to have the PICC line removed because they achieved full enteral nutrition as compared with the other causes ( OR 95 % , confidence interval ( CI ) = 10.35 ( 4.88 to 21.96 ) ) .
-RESULTS	There was no statistical difference between the two groups in the number of attempts until successful PICC line insertion ( P = 0.667 ) and the mean duration of stay of the PICC line ( P = 0.97 ) .
-CONCLUSIONS	The use of the axillary vein as a site of insertion of a PICC line was correlated with significantly less complications in premature newborns as opposed to the other sites of insertion .
-
-###24301456
-BACKGROUND	Human equilibrative nucleoside transporter 1 ( hENT1 ) levels in pancreatic adenocarcinoma may predict survival in patients who receive adjuvant gemcitabine after resection .
-METHODS	Microarrays from 434 patients randomized to chemotherapy in the ESPAC-3 trial ( plus controls from ESPAC-1 / 3 ) were stained with the 10D7G2 anti-hENT1 antibody .
-METHODS	Patients were classified as having high hENT1 expression if the mean H score for their cores was above the overall median H score ( 48 ) .
-METHODS	High and low hENT1-expressing groups were compared using Kaplan-Meier curves , log-rank tests , and Cox proportional hazards models .
-METHODS	All statistical tests were two-sided .
-RESULTS	Three hundred eighty patients ( 87.6 % ) and 1808 cores were suitable and included in the final analysis .
-RESULTS	Median overall survival for gemcitabine-treated patients ( n = 176 ) was 23.4 ( 95 % confidence interval [ CI ] = 18.3 to 26.0 ) months vs 23.5 ( 95 % CI = 19.8 to 27.3 ) months for 176 patients treated with 5-fluorouracil/folinic acid ( ( 2 ) 1 = 0.24 ; P = .62 ) .
-RESULTS	Median survival for patients treated with gemcitabine was 17.1 ( 95 % CI = 14.3 to 23.8 ) months for those with low hENT1 expression vs 26.2 ( 95 % CI = 21.2 to 31.4 ) months for those with high hENT1 expression ( ( 2 ) = 9.87 ; P = .002 ) .
-RESULTS	For the 5-fluorouracil group , median survival was 25.6 ( 95 % CI = 20.1 to 27.9 ) and 21.9 ( 95 % CI = 16.0 to 28.3 ) months for those with low and high hENT1 expression , respectively ( ( 2 ) = 0.83 ; P = .36 ) .
-RESULTS	hENT1 levels were not predictive of survival for the 28 patients of the observation group ( ( 2 ) = 0.37 ; P = .54 ) .
-RESULTS	Multivariable analysis confirmed hENT1 expression as a predictive marker in gemcitabine-treated ( Wald ( 2 ) = 9.16 ; P = .003 ) but not 5-fluorouracil-treated ( Wald ( 2 ) = 1.22 ; P = .27 ) patients .
-CONCLUSIONS	Subject to prospective validation , gemcitabine should not be used for patients with low tumor hENT1 expression .
-
-###24517053
-OBJECTIVE	To evaluate the clinical efficacy of a series of Tongfeng Granule ( TG ) in treating gouty arthritis patients in different stages .
-METHODS	Ninety primary gout patients were randomly assigned to two groups , the TCM treatment group ( 60 cases ) and the Western medicine control group ( 30 cases ) .
-METHODS	Huzhang Tongfeng Granule in combination of external application of Jinhuang Ointment were given to those in the TCM treatment group in the acute phase , and Yinlian Tongfeng Granule in the remission phase .
-METHODS	Diclofenac Sodium Sustained Release Capsule in combination of external application of Jinhuang Ointment were given to those in the Western medicine control group in the acute phase , and Benzbromarone in the remission phase .
-METHODS	All were treated for three months .
-METHODS	The severity integral of symptoms , effective time , effective rate in the acute phase , the recurrence rate , blood uric acid ( BUA ) , urine uric acid ( UUA ) , serum creatinine ( SCr ) , blood urea nitrogen ( BUN ) , triglyceride ( TG ) , total cholesterol ( TC ) , fasting plasma glucose ( FPG ) , and the incidence of adverse reactions were observed in the two groups during the course of treatment .
-RESULTS	The severity integral of symptoms was lowered in the two groups when compared with a former time point ( P < 0.05 ) .
-RESULTS	There was no statistical difference in markedly effective rate or the effective rate in the acute phase between the two groups ( P > 0.05 ) .
-RESULTS	There was statistical difference in the difference of BUA or UUA between before and after treatment in the two groups ( P < 0.05 ) .
-RESULTS	There was statistical difference in TG and SCr in the TCM group between after treatment and before treatment ( P < 0.05 ) .
-RESULTS	There was statistical difference in TG and SCr in the two groups between after treatment and before treatment ( P < 0.05 ) .
-RESULTS	The recurrence rate was 3.3 % in the TCM treatment group ( 2/60 ) , lower than that of the Western medicine control group ( 20 % , 6/30 , P < 0.05 ) .
-CONCLUSIONS	A series of Tongfeng Granule could promote the excretion of UUA , reduce the BUA level in the intermission phase , and play a favorable role in the prevention of relapse .
-CONCLUSIONS	Huzhang Tongfeng Granule could significantly improve inflammatory symptoms and signs of gouty arthritis patients in the acute phase .
-
-###24670844
-OBJECTIVE	National Surgical Adjuvant Breast and Bowel Project ( NSABP ) R-04 was a randomized controlled trial of neoadjuvant chemoradiotherapy in patients with resectable stage II-III rectal cancer .
-OBJECTIVE	We hypothesized that patients who underwent abdominoperineal resection ( APR ) would have a poorer quality of life than those who underwent sphincter-sparing surgery ( SSS ) .
-METHODS	To obtain patient-reported outcomes ( PROs ) we administered two symptom scales at baseline and 1 year postoperatively : the Functional Assessment of Cancer Therapy-Colorectal ( FACT-C ) and the European Organization for the Research and Treatment of Cancer module for patients with Colorectal Cancer Quality of Life Questionnaire ( EORTC QLQ-CR38 ) .
-METHODS	Scoring was stratified by nonrandomly assigned definitive surgery ( APR vs SSS ) .
-METHODS	Analyses controlled for baseline scores and stratification factors : age , sex , stage , intended surgery , and randomly assigned chemoradiotherapy .
-RESULTS	Of 1,608 randomly assigned patients , 987 had data for planned analyses ; 62 % underwent SSS ; 38 % underwent APR. .
-RESULTS	FACT-C total and subscale scores were not statistically different by surgery at 1 year .
-RESULTS	For the EORTC QLQ-CR38 functional scales , APR patients reported worse body image ( 70.3 vs 77.0 , P = 0.0005 ) at 1 year than did SSS patients .
-RESULTS	Males undergoing APR reported worse sexual enjoyment ( 43.7 vs 54.7 , P = 0.02 ) at 1 year than did those undergoing SSS .
-RESULTS	For the EORTC QLQ-CR38 symptom scale scores , APR patients reported worse micturition symptoms than the SSS group at 1 year ( 26.9 vs 21.5 , P = 0.03 ) .
-RESULTS	SSS patients reported worse gastrointestinal tract symptoms than did the APR patients ( 18.9 vs 15.2 , P < 0.0001 ) , as well as weight loss ( 10.1 vs 6.0 , P = 0.002 ) .
-CONCLUSIONS	Symptoms and functional problems were detected at 1 year by EORTC QLQ-CR38 , reflecting different symptom profiles in patients who underwent APR than those who underwent SSS .
-CONCLUSIONS	Information from these PROs may be useful in counseling patients anticipating surgery for rectal cancer .
-
-###24326593
-BACKGROUND	Proximal humeral fractures are mainly associated with osteoporosis and are becoming more common with the aging of our society .
-BACKGROUND	The best surgical approach for internal fixation of displaced proximal humeral fractures is still being debated .
-OBJECTIVE	In this prospective randomized study , we aimed to investigate whether the deltoid-split approach is superior to the deltopectoral approach with regard to ( 1 ) complication rate ; ( 2 ) shoulder function ( Constant score ) ; and ( 3 ) pain ( visual analog scale [ VAS ] ) for internal fixation of displaced humeral fractures with a polyaxial locking plate .
-METHODS	We randomized 120 patients with proximal humeral fractures to receive one of these two approaches ( 60 patients for each approach ) .
-METHODS	We prospectively documented demographic and perioperative data ( sex , age , fracture type , hospital stay , operation time , and fluoroscopy time ) as well as complications .
-METHODS	Followup examinations were conducted at 6 weeks , 6 months , and 12 months postoperatively , including radiological and clinical evaluations ( Constant score , activities of daily living , and pain [ VAS ] ) .
-METHODS	Baseline and perioperative data were comparable for both approaches .
-METHODS	The sample size was chosen to provide 80 % power , but it reached only 68 % as a result of the loss of followups to detect a 10-point difference on the Constant score , which we considered the minimum clinically important difference .
-RESULTS	Complications or reoperations between the approaches were not different .
-RESULTS	Eight patients in the deltoid-split group ( 14 % ) needed surgical revisions compared with seven patients in the deltopectoral group ( 13 % ; p = 1.00 ) .
-RESULTS	Deltoid-split and deltopectoral approaches showed similar Constant scores 12 months postoperatively ( Deltoid-split 81 ; 95 % confidence interval [ CI ] , 74-87 versus deltopectoral 73 ; 95 % CI , 64-81 ; p = 0.13 ) , and there were no differences between the groups in terms of pain at 1 year ( deltoid-split 1.8 ; 95 % CI , 1.2-1 .4 versus deltopectoral 2.5 ; 95 % CI , 1.7-3 .2 ; p = 0.14 ) .
-RESULTS	No learning-curve effects were noted ; fluoroscopy use during surgery and function and pain scores during followups were similar among the first 30 patients and the next 30 patients treated in each group .
-CONCLUSIONS	The treatment of proximal humeral fractures with a polyaxial locking plate is reliable using both approaches .
-CONCLUSIONS	For a definitive recommendation for one of these approaches , further studies with appropriate sample size are necessary .
-METHODS	Level II , therapeutic study .
-METHODS	See the Guidelines for Authors for a complete description of levels of evidence .
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-###25147092
-OBJECTIVE	To assess whether chewing gum prevents postoperative ileus after laparotomy for benign gynecologic surgery .
-METHODS	A randomized study was conducted from December 1 , 2010 , to February 29 , 2012 .
-METHODS	Patients scheduled to undergo laparotomy were randomly assigned to receive chewing gum or routine care after surgery .
-METHODS	A chart review was performed to establish incidence of nausea and vomiting , use of antiemetics , cases of postoperative ileus ( 2 episodes of emesis of 100 mL or more , with abdominal distention and absence of bowel sounds ) , and time to discharge .
-METHODS	Inpatient surveys recorded the time to specific events .
-RESULTS	A total of 109 patients were randomly assigned to receive chewing gum ( n = 51 ) or routine postoperative care ( n = 58 ) .
-RESULTS	Fewer participants assigned to receive chewing gum than routine care experienced postoperative nausea ( 16 [ 31.4 % ] versus 29 [ 50.0 % ] ; P = 0.049 ) and postoperative ileus ( 0 vs. 5 [ 8.6 % ] ; P = 0.032 ) .
-RESULTS	There were no differences in the need for postoperative antiemetics , episodes of postoperative vomiting , readmissions , repeat surgeries , time to first hunger , time to toleration of clear liquids , time to regular diet , time to first flatus , or time to discharge .
-CONCLUSIONS	Chewing gum after laparotomy for gynecologic surgery is safe and lowers the incidence of postoperative ileus and nausea .
-CONCLUSIONS	ClinicalTrials.gov : NCT01579175 .
-
-###25593051
-BACKGROUND	Among patients without cardiovascular disease ( CVD ) and low 10-year CVD risk , the risks of gastrointestinal bleeding and hemorrhagic strokes associated with aspirin use outweigh any potential atheroprotective benefit .
-BACKGROUND	According to the guidelines on primary prevention of CVD , aspirin use is considered appropriate only in patients with 10-year CVD risk 6 % and inappropriate in patients with 10-year CVD risk < 6 % .
-OBJECTIVE	The goal of this study was to examine the frequency and practice-level variation in inappropriate aspirin use for primary prevention in a large U.S. nationwide registry .
-METHODS	Within the National Cardiovascular Disease Registry 's Practice Innovation and Clinical Excellence registry , we assessed 68,808 unique patients receiving aspirin for primary prevention from 119 U.S. practices .
-METHODS	The frequency of inappropriate aspirin use was determined for primary prevention ( aspirin use in those with 10-year CVD risk < 6 % ) .
-METHODS	Using hierarchical regression models , the extent of practice-level variation using the median rate ratio ( MRR ) was assessed .
-RESULTS	Inappropriate aspirin use frequency was 11.6 % ( 7,972 of 68,808 ) in the overall cohort .
-RESULTS	There was significant practice-level variation in inappropriate use ( range 0 % to 71.8 % ; median 10.1 % ; interquartile range 6.4 % ) for practices ; adjusted MRR was 1.63 ( 95 % confidence interval [ CI ] : 1.47 to 1.77 ) .
-RESULTS	Results remained consistent after excluding 21,052 women age 65 years ( inappropriate aspirin use 15.2 % ; median practice-level inappropriate aspirin use 13.8 % ; interquartile range 8.2 % ; adjusted MRR 1.61 [ 95 % CI : 1.46 to 1.75 ] ) and after excluding patients with diabetes ( inappropriate aspirin use 13.9 % ; median practice-level inappropriate aspirin use 12.4 % ; interquartile range 7.6 % ; adjusted MRR 1.55 [ 95 % CI : 1.41 to 1.67 ] ) .
-CONCLUSIONS	More than 1 in 10 patients in this national registry were receiving inappropriate aspirin therapy for primary prevention , with significant practice-level variations .
-CONCLUSIONS	Our findings suggest that there are important opportunities to improve evidence-based aspirin use for the primary prevention of CVD .
-
-###25342898
-BACKGROUND	Combining bronchodilators with different mechanisms of action may improve efficacy and reduce risk of side effects compared to increasing the dose of a single agent in chronic obstructive pulmonary disease ( COPD ) .
-BACKGROUND	We investigated this by combining two long-acting bronchodilators : once-daily muscarinic antagonist tiotropium and once-daily 2-agonist olodaterol .
-METHODS	Two replicate , double-blind , randomized , 12-week studies ( ANHELTO 1 [ NCT01694771 ] and ANHELTO 2 [ NCT01696058 ] ) evaluated the efficacy and safety of olodaterol 5 g once daily ( via Respimat ( ) ) combined with tiotropium 18 g once daily ( via HandiHaler ( ) ) versus tiotropium 18 g once daily ( via HandiHaler ( ) ) combined with placebo ( via Respimat ( ) ) in patients with moderate to severe COPD .
-METHODS	Primary efficacy end points were area under the curve from 0-3 hours of forced expiratory volume in 1 second ( FEV1 AUC0-3 ) and trough FEV1 after 12 weeks ( for the individual trials ) .
-METHODS	A key secondary end point was health status by St George 's Respiratory Questionnaire ( SGRQ ) total score ( combined data set ) .
-RESULTS	Olodaterol + tiotropium resulted in significant improvements over tiotropium + placebo in FEV1 AUC0-3 ( treatment differences : 0.117 L [ P < 0.001 ] , ANHELTO 1 ; 0.106 L [ P < 0.001 ] , ANHELTO 2 ) and trough FEV1 ( treatment differences : 0.062 L [ P < 0.001 ] , ANHELTO 1 ; 0.040 L [ P = 0.0029 ] , ANHELTO 2 ) ; these were supported by secondary end points .
-RESULTS	These effects translated to improvements in SGRQ total scores ( treatment difference -1.85 ; P < 0.0001 ) .
-RESULTS	The tolerability profile of olodaterol + tiotropium was similar to tiotropium monotherapy .
-CONCLUSIONS	These studies demonstrated that olodaterol ( Respimat ( ) ) and tiotropium ( HandiHaler ( ) ) provided bronchodilatory effects above tiotropium alone in patients with COPD .
-CONCLUSIONS	In general , both treatments were well tolerated .
-
-###25446409
-OBJECTIVE	To compare surgical outcomes of volar locking plates ( VP ) and external fixation ( EF ) ( with or without intra-focal fixation ) for AO-type C2 and C3 fractures of the distal radius .
-METHODS	From an initial group of 92 patients with AO-type C2 and C3 distal radius fractures who were enrolled in a prospective , randomized study comparing volar plate fixation with external fixation ( with or without intra-focal fixation ) , 74 patients were studied .
-METHODS	The researchers evaluated functional assessments ( wrist range of motion , grip strength , and Michigan Hand Questionnaire ) at each patient visit and measured radiographic assessment ( radial inclination , volar tilt , ulnar variance , and articular congruity ) at 12 months .
-RESULTS	The grip strength of the VP group was significantly greater than that of the EF group at 3 and 6 months .
-RESULTS	The range of motion was significantly greater in the VP group than in the EF group at 3 months .
-RESULTS	There were no significant differences in the range of motion and grip strength between the 2 groups at 12 months .
-RESULTS	The Michigan Hand Questionnaire score was higher in the VP group than in the EF group at 3 months but was same at 12 months .
-RESULTS	There was no significant difference between groups with respect to volar tilt or radial inclination .
-RESULTS	The VP group showed superior radiologic outcomes in terms of the ulnar variance .
-RESULTS	One patient in the VP group and 3 in the EF group had an intra-articular stepoff deformity greater than 2 mm .
-RESULTS	This difference did not reach statistical significance .
-CONCLUSIONS	These results for functional recovery after distal radius surgery offer insight into treatment decisions and interpretations of treatment outcomes for patients with comminuted intra-articular distal radius fractures .
-
-###25185099
-OBJECTIVE	Currently , antiangiogenic strategies in metastatic breast cancer have demonstrated modest improvements in progression-free survival ( PFS ) but not improved quality or duration of survival , warranting evaluation of new agents in a placebo-controlled setting .
-OBJECTIVE	Ramucirumab is a human immunoglobulin G1 antibody that binds vascular endothelial growth factor receptor-2 and blocks ligand-stimulated activation .
-OBJECTIVE	The ROSE/TRIO -012 trial evaluated ramucirumab with docetaxel in unresectable , locally recurrent , or metastatic breast cancer .
-METHODS	In this double-blind , placebo-controlled , randomized , multinational phase III trial , 1,144 patients with human epidermal growth factor receptor 2 ( HER2 ) - negative breast cancer who had not received cytotoxic chemotherapy in the advanced setting were randomly assigned at a two-to-one ratio to receive docetaxel 75 mg/m ( 2 ) plus ramucirumab 10 mg/kg or docetaxel 75 mg/m ( 2 ) plus placebo once every 3 weeks .
-METHODS	Treatment continued until disease progression , unacceptable toxicity , or other withdrawal criteria .
-METHODS	Patients were stratified by previous taxane therapy , visceral metastasis , hormone receptor status , and geographic region .
-METHODS	An independent data monitoring committee oversaw the trial .
-METHODS	The primary end point was investigator-assessed PFS .
-RESULTS	Median PFS in patients treated with ramucirumab plus docetaxel was 9.5 months , compared with 8.2 months in patients who received placebo plus docetaxel ( hazard ratio [ HR ] , 0.88 ; P = .077 ) .
-RESULTS	Median overall survival was 27.3 months in patients who received ramucirumab plus docetaxel , compared with 27.2 months in patients who received placebo plus docetaxel ( HR , 1.01 ; P = .915 ) .
-RESULTS	Toxicities seen at significantly higher rates in patients receiving ramucirumab included fatigue , hypertension , febrile neutropenia , palmar-plantar erythrodysesthesia syndrome , and stomatitis .
-CONCLUSIONS	Addition of ramucirumab to docetaxel in HER2-negative advanced breast cancer did not meaningfully improve important clinical outcomes .
-
-###25391692
-BACKGROUND	The Focused Abdominal Sonography in Trauma ( FAST ) scan is used to detect free fluid in the peritoneal cavity , or pericardium , to quickly assess for injuries needing immediate surgical intervention .
-BACKGROUND	Mass-casualty incidents ( MCIs ) are settings where paramedics must make triage decisions in minutes .
-BACKGROUND	The Simple Triage and Rapid Transport ( START ) system is used to prioritize transport .
-BACKGROUND	The FAST scan can be added to the triage of critical patients , and may aid in triage .
-METHODS	This was a single-blinded , randomized control trial .
-METHODS	Ten paramedics with field experience were trained with an ultrasound machine in the performance of the FAST scan .
-METHODS	Two weeks were allowed to pass before testing to simulate the time between training of standard procedures and their implementation .
-METHODS	On test day , five peritoneal dialysis patients with instilled dialysis fluid and five matched control patients were placed in a room in a random order where the paramedics performed FAST scans on each patient .
-METHODS	The paramedics were assessed by declaring positive or negative for each evaluation , as well as being timed for the total exercise .
-RESULTS	Of the ninety tests ( one paramedic dropped out due to family emergency ) , the paramedics had a mean accuracy of 60 % and median of 62 % ( range 40 % -80 % ) .
-RESULTS	There was a statistically significant higher false-positive rate of 59 % than false-negative rate of 41 % ( P < .01 ) .
-RESULTS	Sensitivity was 67 % with a specificity of 56 % .
-RESULTS	Average time taken was 1,218 seconds ( 121.8 seconds per patient ) with a range of 735-1 ,701 seconds and a median of 1,108 seconds .
-CONCLUSIONS	In this simulation study , paramedics had difficulty performing FAST scans with a high degree of accuracy .
-CONCLUSIONS	However , they were more apt to call a patient positive , limiting the likelihood for false-negative triage .
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-###25077601
-OBJECTIVE	To investigate the role of Platelet Activating Factor ( PAF ) in the pathogenesis and development of Age-Related Macular Degeneration ( ARMD ) .
-METHODS	Fifty six patients with ARMD ( 24 patients with dry ARMD and 32 patients with wet ARMD ) and 25 age-matched control participants underwent ophthalmological examination , including visual acuity measurement and evaluation of the retina .
-METHODS	The participants were classified into three groups according to their retinal status , based on indirect fundoscopy , Optical Coherence Tomography and fluorescein angiography findings .
-METHODS	In order to evaluate the concentrations of PAF in serum , blood samples were collected from all participants and were analyzed with ELISA technique .
-RESULTS	The concentrations of PAF differed significantly according to macular lesions and were found to be lower in patients with ARMD than control participants .
-CONCLUSIONS	PAF levels are decreased along with the severity of ARMD .
-CONCLUSIONS	Understanding the role of PAF in pathogenesis of ARMD could be the impetus for the development of new therapies field of treatment of ARMD or even other retinal diseases .
-
-###24618837
-BACKGROUND	In a previous UK multi-center randomized study 278 children received three doses of 7-valent ( PCV-7 ) or 13-valent ( PCV-13 ) pneumococcal conjugate vaccine at 2 , 4 and 12 months of age .
-BACKGROUND	At 13 months of age , most of these children had pneumococcal serotype-specific IgG concentrations 0.35 g/ml and opsonophagocytic assay ( OPA ) titers 8 .
-METHODS	Children who had participated in the original study were enrolled again at 3.5 years of age .
-METHODS	Persistence of immunity following infant immunization with either PCV-7 or PCV-13 and the immune response to a PCV-13 booster at pre-school age were investigated .
-RESULTS	In total , 108 children were followed-up to the age of 3.5 years and received a PCV-13 booster at this age .
-RESULTS	At least 76 % of children who received PCV-7 or PCV-13 in infancy retained serotype-specific IgG concentrations 0.35 g/ml against each of 5/7 shared serotypes .
-RESULTS	For serotypes 4 and 18C , persistence was lower at 22-42 % .
-RESULTS	At least 71 % of PCV-13 group participants had IgG concentrations 0.35 g/ml against each of 4/6 of the additional PCV-13 serotypes ; for serotypes 1 and 3 this proportion was 45 % and 52 % .
-RESULTS	In the PCV-7 group these percentages were significantly lower for serotypes 1 , 5 and 7F .
-RESULTS	A pre-school PCV-13 booster was highly immunogenic and resulted in low rates of local and systemic adverse effects .
-CONCLUSIONS	Despite some decline in antibody from 13 months of age , these data suggest that a majority of pre-school children maintain protective serotype-specific antibody concentrations following conjugate vaccination at 2 , 4 and 12 months of age .
-BACKGROUND	ClinicalTrials.gov NCT01095471 .
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-###24468068
-BACKGROUND	Asymmetric movements with both hands contributed to the improvement of spatially coupled motion .
-BACKGROUND	Thus , the aim of this study was to investigate the effects of an asymmetric training program using virtual reality reflection equipment on upper limb function in stroke patients .
-METHODS	Twenty-four stroke patients were randomly allocated to an experimental group ( n = 12 ) or a control group ( n = 12 ) .
-METHODS	Both groups participated in conventional physical therapy for 230 min/d , 5 d/wk , for 4 weeks .
-METHODS	The experimental group also participated in an asymmetric training program using virtual reality reflection equipment , and the control group participated in a symmetric training program .
-METHODS	Both asymmetric and symmetric programs were conducted for 30 min/d , 5 d/wk , for 4 weeks .
-METHODS	To compare upper limb function before and after intervention , the Fugl-Meyer Assessment ( FMA ) , the Box and Block Test ( BBT ) , grip strength , range of motion ( ROM ) , and spasticity were assessed .
-RESULTS	Both groups showed significant increases in upper limb function , excepting spasticity , after intervention ( P < .05 , 1-way repeated-measures analysis of variance [ ANOVA ] ) .
-RESULTS	A significant group-time interaction was demonstrated only for shoulder/elbow/wrist items of FMA , BBT , grip strength , and ROM of wrist flexion , extension , and ulnar deviation ( P < .05 , 2-way repeated-measures ANOVA ) .
-CONCLUSIONS	This study confirms that the asymmetric training program using virtual reality reflection equipment is an effective intervention method for improving upper limb function in stroke patients .
-CONCLUSIONS	We consider that an additional study based on a program using virtual reflection , which is more functional than performing simple tasks , and consisting of tasks relevant to the activities of daily living be conducted .
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-###25000552
-OBJECTIVE	We aimed to evaluate the clinical efficacy of ciprofloxacin plus fluocinolone acetonide ( antibiotic plus corticosteroid ) ear drops compared to ciprofloxacin ( antibiotic ) ear drops in diffuse otitis externa .
-METHODS	This was a multicentre , randomised , parallel-group , double-blind study involving 590 patients of both sexes aged 7years or older .
-RESULTS	The rate of clinical cure was higher ( p = 0.01 ) with ciprofloxacin plus fluocinolone acetonide than with ciprofloxacin alone .
-RESULTS	The mean total symptom score was lower with ciprofloxacin plus fluocinolone acetonide ( p = 0.005 ) .
-RESULTS	No differences were found in the percentage of patients reporting resolution of otalgia between patients receiving ciprofloxacin plus fluocinolone acetonide and patients receiving only ciprofloxacin .
-RESULTS	Resolution of oedema and otorrhoea ( p = 0.003 and p = 0.002 , respectively ) was higher with ciprofloxacin plus fluocinolone acetonide , as was eradication or presumed eradication ( p = 0.003 ) .
-RESULTS	There were eight mild adverse events , three with the ciprofloxacin plus fluocinolone acetonide combination ( not related to the treatment ) and five when ciprofloxacin was administered alone ( directly related to the treatment ) .
-CONCLUSIONS	Ciprofloxacin plus fluocinolone acetonide is a more effective treatment for diffuse otitis externa than ciprofloxacin alone .
-CONCLUSIONS	The ciprofloxacin plus fluocinolone acetonide combination also has an excellent safety profile .
-
-###24912653
-BACKGROUND	Prophylactic use of fresh-frozen plasma ( FFP ) is common practice in patients with a coagulopathy undergoing an invasive procedure .
-BACKGROUND	Evidence that FFP prevents bleeding is lacking , while risks of transfusion-related morbidity after FFP have been well demonstrated .
-BACKGROUND	We aimed to assess whether omitting prophylactic FFP transfusion in nonbleeding critically ill patients with a coagulopathy who undergo an intervention is noninferior to a prophylactic transfusion of FFP .
-METHODS	A multicenter randomized open-label trial with blinded endpoint evaluation was performed in critically ill patients with a prolonged international normalized ratio ( INR ; 1.5-3 .0 ) .
-METHODS	Patients undergoing placement of a central venous catheter , percutaneous tracheostomy , chest tube , or abscess drainage were eligible .
-METHODS	Patients with clinically overt bleeding , thrombocytopenia , or therapeutic use of anticoagulants were excluded .
-METHODS	Patients were randomly assigned to omitting or administering a prophylactic transfusion of FFP ( 12mL/kg ) .
-METHODS	Outcomes were occurrence of postprocedural bleeding complications , INR correction , and occurrence of lung injury .
-RESULTS	Due to slow inclusion , the trial was stopped before the predefined target enrollment was reached .
-RESULTS	Eighty-one patients were randomly assigned , 40 to FFP and 41 to no FFP transfusion .
-RESULTS	Incidence of bleeding did not differ between groups , with a total of one major and 13 minor bleedings ( p = 0.08 for noninferiority ) .
-RESULTS	FFP transfusion resulted in a reduction of INR to less than 1.5 in 54 % of transfused patients .
-RESULTS	No differences in lung injury scores were observed .
-CONCLUSIONS	In critically ill patients undergoing an invasive procedure , no difference in bleeding complications was found regardless whether FFP was prophylactically administered or not .
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-###25194085
-OBJECTIVE	Chronic bacterial prostatitis displays a variety of symptoms ( mainly local pain exhibiting variability in origin and intensity ) .
-OBJECTIVE	These symptoms often persist despite bacterial eradication .
-OBJECTIVE	The purpose of this article is to exam the role of phytotherapeutic agents as complementary treatment in patients with bacterial prostatitis .
-METHODS	The material consisted of individuals with reported pelvic discomfort and genital pain with or without lower urinary tract symptoms ( LUTS ) and sexual dysfunction visiting our department from March 2009 to March 2011 .
-METHODS	Patients underwent Stamey-Meares test ( several cases underwent the two glass test ) .
-METHODS	Depending on history and specific symptoms urethral smear and semen cultures were additionally obtained from several patients .
-METHODS	All patients were randomized into two groups .
-METHODS	Subjects in the first group ( 72 patients ) received appropriate antibiotic ( according to the sensitivity test ) for 15 days , while subjects in the second group ( 72 patients ) received phytotherapeutic agents for 30 days , additionally the conventional 15 days antibiotic treatment .
-METHODS	The response was tested using laboratory and clinical criteria .
-RESULTS	We found no statistically significant differences between the two groups regarding bacterial and symptom persistence rate , however , symptoms burden was lower in patients receiving combinational treatment .
-CONCLUSIONS	Phytotherapeutic agents may improve pain and prostatitis related difficulty in urination .
-CONCLUSIONS	Further randomized , placebo-controlled studies are needed to substantiate safer conclusions .
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-###24228532
-OBJECTIVE	To observe the effect and safety of Xiaozhi particles , integrated taohong Siwu tang and Erchen tang and Xuezhikang capsule in treating hyperlipidaemia ( HLP ) associated with highly active antiretroviral therapy ( HAART ) .
-METHODS	In the multi-centered , randomized controlled clinical study , 180 hyperlipidaemia associated with highly active antiretroviral therapy cases were divided into the treatment group treated by Xiaozhi particles , integrated Taohong Siwu tang and Erchen tang , and the control group treated by Xuezhikang capsule .
-METHODS	The treatment course was 12 weeks .
-METHODS	The total cholesterol ( Tch ) , triglyceride ( TG ) , low density lipoprotein ( LDL ) and high-density lipoprotein ( HDL ) were observed .
-RESULTS	After 12 weeks , compared with Xuezhikang capsule , the change difference of Tch , LDL , HDL in the Chinese traditional medicine formula groups of patients is significant ( P < 0.05 ) , the change of the TG has no significant difference .
-RESULTS	The effect of Tch , LDL in Xuezhikang capsule groups is better than in traditional Chinese medicine formula group , but the effect of HDL in traditional Chinese medicine formula group is better than in Xuezhikang capsule groups .
-CONCLUSIONS	Integrated Taohong Siwu tang and Erchen tang , Xiaozhi particles and Xuezhikang capsule can be used to control the hyperlipidaemia associated with highly active antiretroviral therapy as one of the main Chinese native medicine preparation .
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-###25006118
-BACKGROUND	Primary care is an ideal setting to treat pediatric obesity .
-BACKGROUND	Effective , low-intensity ( 25 contact hours over 6 months ) interventions that reduce standardized body mass index ( z-BMI ) and can be delivered by primary care providers are needed .
-OBJECTIVE	This pilot randomized controlled trial investigated the effect of 3 low-intensity ( 25 contact hours over 6 months ) pediatric obesity treatments on z-BMI .
-METHODS	Twenty-two families ( children 8.0 1.8 years , z-BMI of 2.34 0.48 ) were randomized into 1 of 3 , 6-month , low-intensity conditions : newsletter ( N ) , newsletter and growth monitoring ( N + GM ) , or newsletter and growth monitoring plus family-based behavioral counseling ( N + GM + BC ) .
-METHODS	Anthropometrics and child eating and leisure-time behaviors were measured .
-RESULTS	Mixed-factor analyses of variance found a significant ( P < .05 ) main effect of time for z-BMI and servings per day of sugar sweetened beverages , with both decreasing over time .
-CONCLUSIONS	Low-intensity obesity treatments can reduce z-BMI and may be more feasible in primary care .
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-###24418801
-OBJECTIVE	To evaluate the efficacy of low-level laser therapy ( LLLT ) applied to acupuncture points on the knee joint in combination with exercise and advice in patients with knee osteoarthritis .
-METHODS	Randomised , double-blind , comparative clinical trial .
-METHODS	Forty-nine patients with knee osteoarthritis were assigned at random into two groups : active laser group ( n = 26 ) and placebo laser group ( n = 23 ) .
-METHODS	Using a gallium aluminium arsenide laser device , patients received either active or placebo LLLT at five acupuncture points on the affected knee during nine sessions .
-METHODS	Patients were assessed using a visual analogue scale ( VAS ) and the Saudi Knee Function Scale ( SKFS ) at baseline , the fifth treatment session , the last treatment session , 6 weeks post intervention and 6 months post intervention .
-RESULTS	VAS scores showed a significant improvement in the active laser group compared with the placebo laser group at 6 weeks post intervention [ mean difference -1.3 , 95 % confidence interval ( CI ) of the difference -2.4 to -0.3 ; P = 0.014 ] and 6 months post intervention ( mean difference -1.8 , 95 % CI of the difference -3.0 to -0.7 ; P = 0.003 ) using the independent samples test .
-RESULTS	SKFS scores also showed a significant improvement in the active laser group compared with the placebo laser group at the last treatment session ( median difference -15 , 95 % CI of the difference -27 to -2 ; P = 0.035 ) and 6 months post intervention ( median difference -21 , 95 % CI of the difference -34 to -7 ; P = 0.006 ) using the Mann-Whitney U test .
-CONCLUSIONS	The results demonstrate that short-term application of LLLT to specific acupuncture points in association with exercise and advice is effective in reducing pain and improving quality of life in patients with knee osteoarthritis .
-
-###25574925
-BACKGROUND	Passive smoking is associated with tuberculosis ( TB ) .
-BACKGROUND	Measures are required to protect non-smoking TB patients from second-hand smoke ( SHS ) .
-METHODS	We developed a behavioural intervention to encourage TB patients to implement smoking restrictions at home in Pakistan .
-OBJECTIVE	To assess the likelihood of such an intervention being successful and to inform a definitive trial in future .
-METHODS	This was a pilot randomised controlled trial in which non-smoking TB patients were randomised to receive either individual-based support or individual-based support combined with family reminders .
-METHODS	We recruited patients living with at least one smoker in their homes .
-METHODS	Our primary outcome was urinary cotinine level as a measure of SHS exposure 2 months post-randomisation .
-RESULTS	Of 273 patients assessed for eligibility , 150 ( 56 % ) patients were recruited and all but one were retained throughout the trial .
-RESULTS	A statistically significant absolute reduction was observed in non-smoking participants ' exposure to SHS based on urinary cotinine levels in both Arm 1 ( 71 % , 95 % CI 61-79 ) and Arm 2 ( 76 % , 95 % CI 67-83 ) between baseline and follow-up at 2 months .
-CONCLUSIONS	The recruitment and retention rates for trial participants make it feasible to conduct a definitive trial in future .
-CONCLUSIONS	The observed effect size makes it worthwhile to conduct such a trial .
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-###25085298
-BACKGROUND	In this study , we aimed to determine the effect of carbon dioxide laser irradiation on enamel surface microhardness .
-METHODS	In this single-blind interventional clinical trial , 16 patients needing at least 2 premolars extracted for orthodontic purposes participated .
-METHODS	In each subject , 1 premolar was treated with the carbon dioxide laser ( beam diameter , 0.2 mm ; power , 0.7 W ) ; the other was exposed to a visible guiding light as the control .
-METHODS	A t-loop was ligated to the bonded brackets to increase caries risk .
-METHODS	After at least 2 months , the teeth were extracted , and the surface microhardness was measured .
-METHODS	Scanning electron microscope evaluation was performed on 1 sample from each group .
-METHODS	Normal distribution of the data was assessed by the Kolmogorov-Smirnov and Shapiro-Wilks tests .
-METHODS	Mean microhardness values of the 2 groups were compared using paired t tests .
-RESULTS	The data had normal distributions .
-RESULTS	Means and standard deviations of the microhardness in the laser-treated and control groups were 301.81 94.29 and 183.9 72.08 Vickers hardness numbers , respectively ; this was different significantly ( P < 0.001 ) .
-RESULTS	Scanning electron microscopy showed the enamel surface melting in the laser-treated specimens .
-CONCLUSIONS	Carbon dioxide laser treatment results in higher enamel surface microhardness around orthodontic brackets .
-CONCLUSIONS	Patients at high risk of caries might benefit from this intervention .
-CONCLUSIONS	Exact control of the laser irradiation parameters is recommended .
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-###24939437
-BACKGROUND	Down syndrome ( DS ) is the most common human chromosomal abnormality .
-BACKGROUND	It is characterized by mental retardation and several metabolic disturbances , including elevated oxidative stress , which may be causally linked .
-BACKGROUND	Treatment with dietary antioxidants has been suggested as a potential method to alleviate the oxidative damage and retardation of DS patients , but prior supplementation work has been equivocal .
-OBJECTIVE	To evaluate the effects of supplementation with antioxidants - tocopherol and - lipoic acid ( ALA ) on oxidative stress biomarkers in DS children .
-METHODS	Ninety-three DS children aged 7-15 years from both sexes were randomly allocated to three groups : - tocopherol ( 400 IU/day ) , ALA ( 100mg/day ) and placebo .
-METHODS	The intervention period was 4 months .
-METHODS	A healthy control group consisted 26 non-DS siblings .
-METHODS	Serum thiobarbituric acid reactive substances ( TBARS ) and urinary 8-hydroxy-2 ' - deoxyguanosine ( 8OHdG ) were used as biomarkers of oxidative stress .
-RESULTS	DS children had greater levels of baseline oxidative stress than their siblings .
-RESULTS	Moreover , males had greater levels of 8OHdG than females ( P < 0.001 ) but there was no significant association between age and biomarkers of oxidative stress .
-RESULTS	Serum levels of TBARS did not change significantly over time , or relative to placebo .
-RESULTS	Although urinary 8OHdG concentrations decreased significantly in both - tocopherol and ALA , groups compared with the baseline levels ( P < 0.001 ) , mean final levels of urinary 8OHdG concentrations differed significantly only between - tocopherol and placebo groups ( P < 0.01 ) .
-CONCLUSIONS	- Tocopherol supplementation of the diets of DS children may attenuate oxidative stress at the DNA level .
-
-###25281275
-BACKGROUND	The only subgroups of patients with heart failure and atrial fibrillation in which the efficacy of cardiac resynchronization therapy has been scientifically proven are patients with indications for right ventricular pacing and patients after atrioventricular junction ablation .
-BACKGROUND	However it is unlikely that atrioventricular junction ablation would be a standard procedure in the majority of the heart failure patients with cardiac resynchronization therapy and concomitant atrial fibrillation due to the irreversible character of the procedure and a spontaneous sinus rhythm resumption that occurs in about 10 % of these patients .
-METHODS	Pilot-CRAfT is the first randomized controlled trial evaluating the efficacy of a rhythm control strategy in atrial fibrillation patients with cardiac resynchronization therapy devices .
-METHODS	The aim of this prospective , single center randomized controlled pilot study is to answer the question whether the patients with cardiac resynchronization therapy and permanent atrial fibrillation would benefit from a strategy to restore and maintain sinus rhythm ( that is ` rhythm control ' strategy ) in comparison to rate control strategy .
-METHODS	The study population consists of 60 patients with heart failure and concomitant long-standing persistent or permanent atrial fibrillation who underwent a cardiac resynchronization therapy device implantation at least 3 months before qualification .
-METHODS	Study participants are randomly assigned to the rhythm control strategy ( including electrical cardioversion and pharmacotherapy ) or to the rate control group whose goal is to control ventricular rate .
-METHODS	The follow-up time is 12 months .
-METHODS	The primary endpoint is the ratio of effectively captured biventricular beats .
-METHODS	The secondary endpoints include peak oxygen consumption , six-minute walk test distance , heart failure symptom escalation , reverse remodelling of the heart on echo and quality of life .
-BACKGROUND	NCT01850277 registered on 22 April 2013 ( ClinicalTrails.gov ) .
-
-###25583139
-BACKGROUND	The American Heart Association has defined a new metric of ideal cardiovascular health as part of its 2020 Impact Goals .
-BACKGROUND	We examined whether psychosocial factors in youth predict ideal cardiovascular health in adulthood .
-RESULTS	Participants were 477 men and 612 women from the nationwide Cardiovascular Risk in Young Finns Study .
-RESULTS	Psychosocial factors were measured from cohorts 3 to 18 years of age at the baseline of the study , and ideal cardiovascular health was examined 27 years later in adulthood .
-RESULTS	The summary measure of psychosocial factors in youth comprised socioeconomic factors , emotional factors , parental health behaviors , stressful events , self-regulation of the child , and social adjustment of the child .
-RESULTS	There was a positive association between a higher number of favorable psychosocial factors in youth and greater ideal cardiovascular health index in adulthood ( = 0.16 ; P < 0.001 ) that persisted after adjustment for age , sex , medication use , and cardiovascular risk factors in childhood ( = 0.15 ; P < 0.001 ) .
-RESULTS	The association was monotonic , suggesting that each increment in favorable psychosocial factors was associated with improvement in cardiovascular health .
-RESULTS	Of the specific psychosocial factors , a favorable socioeconomic environment ( = 0.12 ; P < 0.001 ) and participants ' self-regulatory behavior ( = 0.07 ; P = 0.004 ) were the strongest predictors of ideal cardiovascular health in adulthood .
-CONCLUSIONS	The findings suggest a dose-response association between favorable psychosocial factors in youth and cardiovascular health in adulthood , as defined by the American Heart Association metrics .
-CONCLUSIONS	The effect seems to persist throughout the range of cardiovascular health , potentially shifting the population distribution of cardiovascular health rather than simply having effects in a high-risk population .
-
-###25295434
-OBJECTIVE	Effects of depression treatment are obscured by heterogeneity among patients .
-OBJECTIVE	Personality types could be one source of heterogeneity that explains variability in treatment response .
-OBJECTIVE	Clinically meaningful variations in personality patterns could be captured with data-driven subgroups .
-OBJECTIVE	The aim of this study was to identify such personality types and to explore their predictive value for treatment efficacy .
-METHODS	Participants ( N = 146 ) in the current exploratory study came from a randomized controlled trial in primary care depressed patients , conducted between January 1998 and June 2003 , comparing different treatments .
-METHODS	All participants were diagnosed with a major depressive disorder ( MDD ) according to the DSM-IV .
-METHODS	Primary ( care as usual [ CAU ] or CAU plus a psychoeducational prevention program [ PEP ] ) and specialized ( CAU + PEP + psychiatric consultation or cognitive-behavioral therapy ) treatment were compared .
-METHODS	Personality was assessed with the Neuroticism-Extraversion-Openness Five-Factor Inventory ( NEO-FFI ) .
-METHODS	Personality classes were identified with latent profile analysis ( LPA ) .
-METHODS	During 1 year , weekly depression ratings were obtained by trimonthly assessment with the Composite International Diagnostic Interview .
-METHODS	Mixed models were used to analyze the effects of personality on treatment efficacy .
-RESULTS	A 2-class LPA solution fit best to the NEO-FFI data : Class 1 ( vulnerable , n = 94 ) was characterized by high neuroticism , low extraversion , and low conscientiousness , and Class 2 ( resilient , n = 52 ) by medium neuroticism and extraversion and higher agreeableness and conscientiousness .
-RESULTS	Recovery was quicker in the resilient class ( class time : P < .001 ) .
-RESULTS	Importantly , specialized treatment had added value only in the vulnerable class , in which it was associated with quicker recovery than primary treatment ( class time treatment : P < .001 ) .
-CONCLUSIONS	Personality profile may predict whether specialized clinical efforts have added value , showing potential implications for planning of treatments .
-
-###25429421
-OBJECTIVE	Selective laser trabeculoplasty ( SLT ) should be explored as a therapeutic option in eyes with angle closure .
-OBJECTIVE	To assess the intraocular pressure ( IOP ) - lowering efficacy of SLT in eyes with primary angle closure ( PAC ) and PAC glaucoma ( PACG ) .
-METHODS	Randomized clinical trial at tertiary eye care institutions of 100 patients diagnosed as having PAC or PAC glaucoma in which the angles had opened at least 180 ( visible posterior trabecular meshwork on gonioscopy ) after laser iridotomy .
-METHODS	Recruitment and baselinewere completed from June 2009 to April 2012 and 6-month follow-up was completed from December 2009 to November 2012 .
-METHODS	Eligible patients with a baseline IOP greater than 21 mm Hg were randomized to either SLT or prostaglandin analog ( PGA ; travoprost , 0.004 % ) .
-METHODS	The SLT was repeated if the IOP reduction was less than 20.0 % from baseline at the 1 - or 3-month follow-up visit .
-METHODS	The primary outcome measure was the change in IOP from baseline to the final follow-up visit ( at 6 months ) .
-METHODS	The frequency of additional postoperative treatments and complications were secondary outcomes .
-RESULTS	Fifty patients ( 96 eyes ) were randomized to SLT and 50 patients ( 99 eyes ) to PGA medical therapy .
-RESULTS	At 6 months , 49 patients in the SLT group and 47 in the PGA group completed follow-up .
-RESULTS	Analysis was based on intent to treat .
-RESULTS	At 6 months , IOP decreased by 4.0 mm Hg ( 95 % CI , 3.2-4 .8 ) in the SLT group ( P < .001 ) and by 4.2 mm Hg ( 95 % CI , 3.5-4 .9 ) in the PGA group ( P < .001 ) .
-RESULTS	There were no differences between the SLT and PGA groups in the absolute mean reduction of IOP ( 4.0 vs 4.2 mm Hg , respectively ; P = .78 ) or in the percentage of reduction in IOP ( 16.9 % vs 18.5 % , respectively ; P = .52 ) .
-RESULTS	Complete success ( IOP 21 mm Hg without medications ) was achieved in 60.0 % eyes of the SLT group , compared with 84.0 % of eyes in the PGA group ( P = .008 ) .
-RESULTS	No patients required glaucoma surgery .
-RESULTS	Additional medications were required in 22.0 % of patients in the SLT group compared with 8.0 % in the PGA group ( P = .05 ) .
-RESULTS	One patient in the SLT group ( 2.0 % ) had a transient posttreatment IOP spike greater than 5 mm Hg .
-RESULTS	The mean endothelial cell count showed a significant decrease from baseline in the SLT arm ( 4.8 % decrease ; P = .001 ) .
-RESULTS	No other events such as persistent uveitis or increase in peripheral anterior synechiae were noted in eyes that underwent SLT .
-RESULTS	Two patients in the PGA group exited owing to drug-related complications ( 1 patient with uveitis and 1 with allergic conjunctivitis ) .
-CONCLUSIONS	Eyes with PAC or PACG respond to SLT in the short term , but the overall long-term therapeutic effectiveness needs further evaluation .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01004900 .
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-###24404664
-OBJECTIVE	The antiseptic effectiveness of 5 % anerdian III , 0.016 % gentamicin , and 0.5 % tobramycin solutions in pre-surgical irrigation of conjunctival sac were compared .
-METHODS	A total of 295 cataract patients ( 302 eyes ) who had undergone phacoemulsification aspiration combined with intraocular lens insertion ( IOL ) were recruited in this prospective study .
-METHODS	Operative eyes were given 0.3 % levofloxacin eye drops for 3 days and then were randomized into three treatment groups : anerdian ( A ) , gentamicin ( B ) and tobramycin ( C ) .
-METHODS	The patients received conjunctival sac irrigation using the respective solutions at 10 minutes preoperatively .
-METHODS	Conjunctival sac sampling was performed before and after irrigation and the samples were used for subsequent bacterial culture and swab tests .
-METHODS	The positive culture rate was used as the main outcome .
-RESULTS	The positive rates of bacterial culture before conjunctival sac irrigation were 17.31 % ( 18 eyes ) in group A , 13.86 % ( 14 eyes ) in group B and 17.3 % ( 14 eyes ) in group C. Post irrigation , the positive rates in the three groups decreased to 5.76 % ( 6 eyes ) , 5.94 % ( 6 eyes ) and 7.22 % ( 7 eyes ) , respectively .
-RESULTS	The positive rates among the three groups did not differ significantly .
-RESULTS	However , the positive rate in group A only significantly differed before and after the irrigation ( P < 0.05 ) .
-RESULTS	No toxic or allergic reactions were observed on the ocular surface of any patient after irrigation .
-CONCLUSIONS	The antiseptic effects of the three types of con junctival sac irrigations did not differ .
-
-###24490645
-OBJECTIVE	Observing or hearing about illness in another person can lead to reports of similar symptoms .
-OBJECTIVE	Reports can occasionally be widespread .
-OBJECTIVE	However , it has been difficult to document whether this is the result of genuine illness or the expression of anxiety with physical terminology .
-OBJECTIVE	This study examined the effects of being able to see another blood donor experience vasovagal symptoms .
-METHODS	Data were collected in mobile university blood collection clinics .
-METHODS	Bedside research assistants coded whether the donor was able or not able to see another donor being treated for vasovagal symptoms .
-METHODS	Dependent variables included subjective vasovagal symptoms indicated on the Blood Donation Reactions Inventory ( BDRI ) and the need for treatment oneself .
-METHODS	Given the population of inexperienced donors , many ( 26 % of the 1,209 participants ) were able to see another donor treated for symptoms .
-RESULTS	Being able to see another donor treated was associated with higher scores on the BDRI and an increased likelihood of treatment for vasovagal symptoms oneself .
-RESULTS	However , this was limited to non-first-time blood donors , perhaps because of higher levels in first-time donors ( ceiling effects ) or greater attention to the environment in less `` overwhelmed '' repeat donors .
-RESULTS	In general , donors who were able to see another react rated themselves as less relaxed and had smaller increases in heart rate .
-RESULTS	During the 2-year follow-up , first-time donors who were able to see another react were slower to return to give blood again .
-CONCLUSIONS	Seeing another donor being treated for symptoms contributed to the vasovagal process in many donors .
-CONCLUSIONS	This environment provides a useful context to study social influences on symptoms and illness .
-
-###25163905
-BACKGROUND	Prostate cancer is a major public health problem with considerable uncertainties about the effectiveness of population screening and treatment options .
-BACKGROUND	We report the study design , participant sociodemographic and clinical characteristics , and the initial results of the testing and diagnostic phase of the Prostate testing for cancer and Treatment ( ProtecT ) trial , which aims to investigate the effectiveness of treatments for localised prostate cancer .
-METHODS	In this randomised phase 3 trial , men aged 50-69 years registered at 337 primary care centres in nine UK cities were invited to attend a specialist nurse appointment for a serum prostate-specific antigen ( PSA ) test .
-METHODS	Prostate biopsies were offered to men with a PSA concentration of 30 g/L or higher .
-METHODS	Consenting participants with clinically localised prostate cancer were randomly assigned to active monitoring ( surveillance strategy ) , radical prostatectomy , or three-dimensional conformal external-beam radiotherapy by a computer-generated allocation system .
-METHODS	Randomisation was stratified by site ( minimised for differences in participant age , PSA results , and Gleason score ) .
-METHODS	The primary endpoint is prostate cancer mortality at a median 10-year follow-up , ascertained by an independent committee , which will be analysed by intention to treat in 2016 .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT02044172 , and as an International Standard Randomised Controlled Trial , number ISRCTN20141297 .
-RESULTS	Between Oct 1 , 2001 , and Jan 20 , 2009 , 228,966 men were invited to attend an appointment with a specialist nurse .
-RESULTS	Of the invited men , 100,444 ( 44 % ) attended their initial appointment and 82,429 ( 82 % ) of attenders had a PSA test .
-RESULTS	PSA concentration was below the biopsy threshold in 73,538 ( 89 % ) men .
-RESULTS	Of the 8566 men with a PSA concentration of 30-199 g/L , 7414 ( 87 % ) underwent biopsies .
-RESULTS	2896 men were diagnosed with prostate cancer ( 4 % of tested men and 39 % of those who had a biopsy ) , of whom 2417 ( 83 % ) had clinically localised disease ( mostly T1c , Gleason score 6 ) .
-RESULTS	With the addition of 247 pilot study participants recruited between 1999 and 2001 , 2664 men were eligible for the treatment trial and 1643 ( 62 % ) agreed to be randomly assigned ( 545 to active monitoring , 545 to radiotherapy , and 553 to radical prostatectomy ) .
-RESULTS	Clinical and sociodemographic characteristics of randomly assigned participants were balanced across treatment groups .
-CONCLUSIONS	The ProtecT trial randomly assigned 1643 men with localised prostate cancer to active monitoring , radiotherapy , or surgery .
-CONCLUSIONS	Participant clinicopathological features are more consistent with contemporary patient characteristics than in previous prostate cancer treatment trials .
-BACKGROUND	UK National Institute for Health Research Health Technology Assessment Programme .
-
-###25591992
-OBJECTIVE	We examined the therapeutic effects of avanafil 15 minutes after dosing in men with mild to severe erectile dysfunction .
-METHODS	This randomized , double-blind , placebo controlled , 12-week study ( 4-week run-in and 8-week treatment ) randomized 145 men to placebo , 147 to avanafil 100 mg and 148 to avanafil 200 mg on demand .
-METHODS	The primary efficacy variable was the per subject proportion of sexual attempts during the treatment period in which subjects achieved erection sufficient for vaginal penetration within approximately 15 minutes after dosing as measured by a stopwatch .
-METHODS	The attempt had to enable successful completion of sexual intercourse according to SEP question 3 .
-RESULTS	Significantly greater mean per subject percentages of successful intercourse attempts within approximately 15 minutes after dosing were observed for avanafil 100 mg ( mean 25.9 % , LS mean SE 24.7 % 2.9 % ) and 200 mg ( mean 29.1 % , LS mean 28.2 % 2.9 % ) vs placebo ( mean 14.9 % , LS mean 13.8 % 2.9 % , p = 0.001 and < 0.001 , respectively ) .
-RESULTS	After treatment we noted a statistically significant difference between avanafil and placebo in the average per subject proportion of successful intercourse attempts according to SEP question 3 as early as 10 minutes in the 200 mg group and 12 minutes in the 100 mg group .
-RESULTS	Treatment emergent adverse events included headache , upper respiratory tract infection and nasal congestion , and most such events were mild or moderate in severity .
-CONCLUSIONS	Avanafil was efficacious within approximately 15 minutes of dosing compared to placebo .
-CONCLUSIONS	A statistically significant treatment difference in the percentage of successful sexual attempts was demonstrated as early as 10 minutes after treatment .
-
-###26160211
-OBJECTIVE	The objective of this study was to compare the efficacy and comfort of inelastic bandages ( IBs ) and adjustable Velcro compression devices ( AVCDs ) in reducing venous leg edema in the initial treatment phase .
-METHODS	Forty legs from 36 patients with untreated venous edema ( C3EpsAsdPr ) were randomized to two groups .
-METHODS	Patients in the first group received IBs ( n = 20 ) and those in the second AVCDs ( n = 20 ) .
-METHODS	Both compression devices were left on the leg day and night , and were renewed after 1 day .
-METHODS	Patients in the AVCD group were asked to re-adjust the device as needed when it felt loose .
-METHODS	Leg volume was calculated using the truncated cone formula at baseline ( T0 ) , after 1 day ( T1 ) and after 7 days ( T7 ) .
-METHODS	The interface pressure of the two compression devices was measured by an air filled probe , and the static stiffness index calculated after applying compression at T0 and T1 , and just before removal of compression on T1 and T7 .
-METHODS	Patient comfort with regard to the two compression systems was assessed by grading signs and symptoms using a visual analog scale .
-RESULTS	At T1 , the median percent volume reduction was 13 % for the IB group versus 19 % for the AVCD group ; at T7 it was 19 % versus 26 % , respectively ( p < .001 ) .
-RESULTS	The pressure of the IBs was significantly higher compared with the AVCDs at T0 ( 63 vs. 43 mmHg ) but dropped by > 50 % over time , while it remained unchanged with AVCDs owing to the periodic readjustment by the patient .
-RESULTS	Comfort was reported to be similar with the two compression devices .
-CONCLUSIONS	Re-adjustable AVCDs with a resting pressure of around 40 mmHg are more effective in reducing chronic venous edema than IBs with a resting pressure of around 60 mmHg .
-CONCLUSIONS	AVCDs are effective and well tolerated , not only during maintenance therapy , but also in the initial decongestive treatment phase of patients with venous leg edema .
-
-###25872782
-BACKGROUND	Gastroparesis is common in surgical patients and frequently leads to the need for enteral tube feeding .
-BACKGROUND	Nasoenteral feeding tubes are usually placed endoscopically by gastroenterologists , but this procedure is relatively cumbersome for patients and labor-intensive for hospital staff .
-BACKGROUND	Electromagnetic ( EM ) guided bedside placement of nasoenteral feeding tubes by nurses may reduce patient discomfort , workload and costs , but randomized studies are lacking , especially in surgical patients .
-BACKGROUND	We hypothesize that EM guided bedside placement of nasoenteral feeding tubes is at least as effective as endoscopic placement in surgical patients , at lower costs .
-METHODS	The CORE trial is an investigator-initiated , parallel-group , pragmatic , multicenter randomized controlled non-inferiority trial .
-METHODS	A total of 154 patients admitted to gastrointestinal surgical wards in five hospitals , requiring nasoenteral feeding , will be randomly allocated to undergo EM guided or endoscopic nasoenteral feeding tube placement .
-METHODS	Primary outcome is reinsertion of the feeding tube , defined as the insertion of an endoscope or tube in the nose/mouth and esophagus for ( re ) placement of the feeding tube ( e.g. after failed initial placement or dislodgement or blockage of the tube ) .
-METHODS	Secondary outcomes include patient-reported outcomes , costs and tube ( placement ) related complications .
-CONCLUSIONS	The CORE trial is designed to generate evidence on the effectiveness of EM guided placement of nasoenteral feeding tubes in surgical patients and the impact on costs as compared to endoscopic placement .
-CONCLUSIONS	The trial potentially offers a strong argument for wider implementation of this technique as method of choice for placement of nasoenteral feeding tubes .
-BACKGROUND	Dutch Trial Register : NTR4420 , date registered 5-feb-2014 .
-
-###24748161
-BACKGROUND	The purpose of this study was to describe hospital and geographic variation in 30-day risk of surgical complications and death among colorectal cancer ( CRC ) patients and the extent to which patient - , hospital - , and census-tract-level characteristics increased risk of these outcomes .
-METHODS	We included patients at least 66years old with first primary stage I-III CRC from the 2000-2005 National Cancer Institute 's Surveillance , Epidemiology , and End Results data linked with 1999-2005 Medicare claims .
-METHODS	A multilevel , cross-classified logistic model was used to account for nesting of patients within hospitals and within residential census tracts .
-METHODS	Outcomes were risk of complications and death after a complication within 30days of surgery .
-RESULTS	Data were analyzed for 35,946 patients undergoing surgery at 1,222 hospitals and residing in 12,187 census tracts ; 27.2 % of patients developed complications , and of these 13.4 % died .
-RESULTS	Risk-adjusted variability in complications across hospitals and census tracts was similar .
-RESULTS	Variability in mortality was larger than variability in complications , across hospitals and across census tracts .
-RESULTS	Specific characteristics increased risk of complications ( e.g. , census-tract-poverty rate , emergency surgery , and being African-American ) .
-RESULTS	No hospital characteristics increased complication risk .
-RESULTS	Specific characteristics increased risk of death ( e.g. census-tract-poverty rate , being diagnosed with colon ( versus rectal ) cancer , and emergency surgery ) , while hospitals with at least 500 beds showed reduced death risk .
-CONCLUSIONS	Large , unexplained variations exist in mortality after surgical complications in CRC across hospitals and geographic areas .
-CONCLUSIONS	The potential exists for quality improvement efforts targeted at the hospital and/or census-tract levels to prevent complications and augment hospitals ' ability to reduce mortality risk .
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-###25310567
-BACKGROUND	Clinicians require portable , valid , and cost-effective methods to monitor knee joint-position-sense ( JPS ) ability .
-OBJECTIVE	To examine the criterion-related validity of image-capture JPS measures against an isokinetic-dynamometer ( IKD ) procedure .
-METHODS	Random crossover design providing a comparison of knee JPS measures from image capture and IKD procedures .
-METHODS	10 healthy participants , 5 female , age 28.0 13.29 y , mass 60.3 9.02 kg , height 1.65 0.07 m , and 5 male , 29.6 10.74 y , mass 73.6 5.86 kg , height 1.75 0.07 m.
-METHODS	The dependent variables were absolute error scores ( AES ) provided by 2 knee directions ( flexion and extension ) .
-METHODS	The independent variables were the method ( image capture and IKD ) .
-RESULTS	There was no significant difference between clinical and IKD AES into knee-flexion data ( P = .263 , r = 0.55 ) .
-RESULTS	There was a significant difference between clinical and IKD AES into knee-extension data ( P = .016 , r = .70 ) .
-CONCLUSIONS	Analysis of photographic images to assess JPS measurements using knee flexion is valid against an IKD positioning method , but JPS measurements using knee extension may not be valid against IKD techniques .
-CONCLUSIONS	However , photo-analysis measurements provided a lower error score using knee-extension data and thus may provide an optimal environment to produce maximal knee JPS acuity .
-CONCLUSIONS	Therefore , clinicians do not need expensive equipment to collect representative JPS ability .
-
-###25654309
-BACKGROUND	Lung volume reduction ( LVR ) techniques improve lung function in selected patients with emphysema , but the impact of LVR procedures on the asynchronous movement of different chest wall compartments , which is a feature of emphysema , is not known .
-METHODS	We used optoelectronic plethysmography to assess the effect of surgical and bronchoscopic LVR on chest wall asynchrony .
-METHODS	Twenty-six patients were assessed before and 3 months after LVR ( surgical [ n = 9 ] or bronchoscopic [ n = 7 ] ) or a sham/unsuccessful bronchoscopic treatment ( control subjects , n = 10 ) .
-METHODS	Chest wall volumes were divided into six compartments ( left and right of each of pulmonary ribcage [ Vrc , p ] , abdominal ribcage [ Vrc , a ] , and abdomen [ Vab ] ) and phase shift angles ( ) calculated for the asynchrony between Vrc , p and Vrc , a ( RC ) , and between Vrc , a and Vab ( DIA ) .
-RESULTS	Participants had an FEV of 34.6 18 % predicted and a residual volume of 217.8 46.0 % predicted with significant chest wall asynchrony during quiet breathing at baseline ( RC , 31.3 38.4 ; and DIA , -38.7 36.3 ) .
-RESULTS	Between-group difference in the change in RC and DIA during quiet breathing following treatment was 44.3 ( 95 % CI , -78 to -10.6 ; P = .003 ) and 34.5 ( 95 % CI , 1.4 to 67.5 ; P = .007 ) toward 0 ( representing perfect synchrony ) , respectively , favoring the LVR group .
-RESULTS	Changes in RC and DIA were statistically significant on the treated but not the untreated sides .
-CONCLUSIONS	Successful LVR significantly reduces chest wall asynchrony in patients with emphysema .
-
-###25658223
-OBJECTIVE	To assess the impact of passive and active promotional strategies on patient acceptance of medication therapy management ( MTM ) services , and to identify reasons for patient acceptance or refusal .
-METHODS	Four promotional approaches were developed to offer MTM services to eligible patients , including letters and bag stuffers ( `` passive '' approaches ) , and face-to-face offers and telephone calls ( `` active '' approaches ) .
-METHODS	Thirty pharmacies in a grocery store chain were randomized to one of the four approaches .
-METHODS	Patient acceptance rates were compared among the four groups , and between active and passive approaches using hierarchical logistic regression techniques .
-METHODS	Depending on their decision to accept or decline the service , patients were invited to take part in one of two brief telephone surveys .
-RESULTS	No significant differences were identified among the four promotional methods or between active and passive methods in the analyses .
-RESULTS	Patients ' most frequent reasons for accepting MTM services were potential cost savings , review of how the medications were working , the expert opinion of the pharmacist , and education about medications .
-RESULTS	Patients ' most frequent reasons for declining MTM services were that the participant already felt comfortable with their medications and felt their pharmacist provides these services on a regular basis .
-CONCLUSIONS	No significant difference was found among any of the four groups or between active or passive approaches .
-CONCLUSIONS	Further research is warranted to identify strategies for improving patient engagement in MTM services .
-
-###25739243
-OBJECTIVE	To compare the effect on surgical indicators and functional outcome between preoperative skeletal traction and skin traction for adult femoral fracture and guide the choice of preoperative traction method of adult femoral fractures .
-METHODS	From February 2008 to September 2012 , 68 patients aged greater than 18-year-old with femoral fractures were treated and randomly divided into two groups according hospitalization order , the odd with skeletal traction of tibial tubercle ( group A ) and the even with skin traction ( group B ) .
-METHODS	In group A , there were 25 males and 9 females with an average age of ( 36.39.9 ) years old , including 11 cases with transverse fracture , 15 cases with oblique fracture , 8 cases with spiral fracture .
-METHODS	In group B , there 26 males and 8 females with an average age of ( 37.111.0 ) years old , including 10 cases with transverse fracture , 13 cases with oblique fracture ,11 cases with spiral fracture .
-METHODS	The operative time , blood loss , the number and amount of blood transfusion , fracture healing time , hemoglobin , pain scores and functional scores between two groups were analyzed and compared .
-METHODS	Results : All patients were followed up , the follow-up time was ( 33.56.5 ) months in group A , ( 31.37.5 ) months in groupB .
-METHODS	In group A , the operation time was ( 108.814.2 ) min and the intraoperative blood loss was ( 383.1117.1 ) ml and the postoperative blood transfusion was 14 cases and the blood transfusion was ( 350.0122.5 ) ml and the average bone healing time was ( 15.03.3 ) weeks .
-METHODS	In group B , the operation time was ( 111.612.7 ) min and the intraoperative blood loss was ( 392.0 116.7 ) ml and the blood transfusion was 11 cases and the blood transfusion was ( 327.3129.1 ) ml and the average healing time was ( 15.53.4 ) weeks .
-METHODS	These obseration indicators had no significant difference between two groups .
-METHODS	There was no significant difference between two groups in terms of Hemoglobin , the pain scores before and after traction , the femoral fractures efficacy score , knee function score and knee range .
-CONCLUSIONS	Preoperative skeletal traction does not reduce surgery time , blood loss and pain and so on .
-CONCLUSIONS	The bone healing time and limb functional outcomes were also not significantly improved .
-
-###26437529
-OBJECTIVE	To evaluate the benefit of aromatic therapy using menthol for decrease pain perception during amniocentesis .
-METHODS	A prospective randomized study was conducted to compare pain level between groups ofpregnant women who underwent amniocentesis with and without aromatic therapy using menthol .
-METHODS	Visual analogue scale ( VAS ) was usedfor pain assessment .
-METHODS	The participants were askedfor their anticipated pain and anxiety level and level ofpain before and immediately after the procedure .
-RESULTS	Three hundred seventeen pregnant women were recruited into the present study , 158 in the menthol group and 159 in the non-menthol group .
-RESULTS	Mean VAS score of the post-procedure pain and anxiety did not differ significantly between the two groups .
-RESULTS	Mean VAS score of the anticipated pain influenced the mean VAS score of the pre-procedure anxiety and post-procedure pain and anxiety irrespective of the group .
-RESULTS	Mean VAS score of the pre-procedure anxiety and post-procedure pain and anxiety increased about 0.3 cm for each 1 cm of increasing mean VAS score of anticipated pain .
-CONCLUSIONS	Aromatic therapy using menthol was not significantly effective in reducing pain and anxiety during second trimester genetic amniocentesis .
-
-###26040181
-OBJECTIVE	Immune response and consequent inflammatory process which originate on ocular surface after a trauma are mediated by cytokines .
-OBJECTIVE	Photoablation of corneal stroma performed by excimer laser causes surgically induced trauma .
-OBJECTIVE	Interleukin-6 ( IL-6 ) is mostly known as a proinflammatory cytokine .
-OBJECTIVE	However , it also has regenerative and anti-inflammatory effects .
-OBJECTIVE	It is supposed that this cytokine is likely to play a significant role in the process of corneal wound healing response after photoablation of stroma carried out by laser in situ keratomileusis ( LASIK ) or photorefractive keratectomy ( PRK ) methods .
-OBJECTIVE	The aim of this study was to determine and compare the levels of IL-6 in tears before and after treatment with LASIK and PRK methods .
-METHODS	The study included 68 shortsighted eyes up to -3.0 diopter sphere , i.e. 198 samples of tears ( per three samples taken from each of the eyes ) , divided into two groups according to the kind of excimer laser intervention performed : the group 1 -- eyes treated by LASIK method ( n = 31 ) , and the group 2 -- eyes treated by the PRK method ( n = 37 ) .
-METHODS	The samples of tears were taken from each eye at the following time points : before excimer laser treatment ( 0 h , the control group ) , 1 h after the treatment ( 1 h ) and 24 h after the treatment ( 24 h ) .
-METHODS	The patients did not use anti-inflammatory therapy 24 h after the intervention .
-METHODS	Tear samples were collected using microsurgical sponge .
-METHODS	Level of IL-6 in tear fluid was determined by the flow cytometry method , applying a commercial test kit which allowed cytokine detection from a small sample volume .
-METHODS	Results .
-METHODS	The values of IL-6 were detectable in 16 % of samples before LASIK treatment and in 30 % of samples before PRK treatment .
-METHODS	One h after the treatment IL-6 was detectable in 29 % of samples for the LASIK group and 43 % of samples for the PRK group , and 24 h after the treatment it was detectable in 19 % of samples for the LASIK group and in 57 % of samples for the PRK group .
-METHODS	When we analyzed the dynamics of IL76 production in particular groups , we noticed that both in the LASIK and PRK group the number of samples with increased values of IL-6 after 1 h , and after 24 h , was con - siderably larger than the number of samples with decreased values of IL-6 after the intervention .
-METHODS	Analyzing the dynamics of IL-6 concentration changes in the 1 h samples vs. 24 h samples there was a statistically significant increase in the number of samples with IL-6 concentration decline in the LASIK group , while at the same time no considerable changes occurred in the PRK group .
-METHODS	Comparing average IL-6 values between the two treatment groups in all tear samples at 0 h , 1 h and 24 h after intervention a significantly higher level in the PRK group 24 h after procedure ( p = 0.0031 ) was detected .
-CONCLUSIONS	IL-6 level in tears increases 1 h and 24 h after LASIK and PRK treatments .
-CONCLUSIONS	This increment is significantly larger 24 h after the treatment with the PRK method than with the LASIK method .
-CONCLUSIONS	Changes of IL-6 production levels in tears after excimer laser treatment indicate that this cytokine takes part in the corneal recovery process after stromal photoablation .
-
-###25187436
-BACKGROUND	Although half of all patients with heart failure ( HF ) have a normal or near-normal ejection fraction and their prognosis differs little from that of patients with a reduced ejection fraction , the pathophysiology of HF with preserved ejection fraction ( HF-PEF ) is still poorly understood , and its management poorly supported by clinical trials .
-BACKGROUND	Sodium and fluid restriction is the most common self-care measure prescribed to HF patients for management of congestive episodes .
-BACKGROUND	However , its role in the treatment of HF-PEF remains unclear .
-BACKGROUND	This trial seeks to compare the effects of a sodium - and fluid-restricted diet versus an unrestricted diet on weight loss , neurohormonal activation , and clinical stability in patients admitted for decompensated HF-PEF .
-METHODS	This is a randomized , parallel trial with blinded outcome assessment .
-METHODS	The sample will include adult patients ( aged 18years ) with a diagnosis of HF-PEF admitted for HF decompensation .
-METHODS	The patients will be randomized to receive a diet with sodium and fluid intake restricted to 0.8 g/day and 800mL/day respectively ( intervention group ) or an unrestricted diet , with 4g/day sodium and unlimited fluid intake ( control group ) , and followed for 7days or until hospital discharge .
-METHODS	The primary outcome shall consist of weight loss at 7days or discharge .
-METHODS	The secondary outcome includes assessment of clinical stability , neurohormonal activation , daily perception of thirst and readmission rate at 30days .
-CONCLUSIONS	Assessment of the effects of sodium and fluid restriction on neurohormonal activation and clinical course of HF-PEF can promote a deeper understanding of the pathophysiology and progression of this complex syndrome .
-BACKGROUND	ClinicalTrials.gov identifier : NCT01896908 ( date of registration : 8 August 2013 ) .
-
-###24913488
-BACKGROUND	New in-vehicle technologies often outpace the scientific support for their value .
-BACKGROUND	In lieu of valid and consistent scientific support , common wisdom is used , as in the assumption that enhanced roadway delineation improves driving safety .
-OBJECTIVE	To evaluate the effects of a Visibility Enhancement System that selectively improves lane markers ' visibility on driving safety .
-METHODS	A simulation experiment assessed the effects of an in-car lane Visibility Enhancement System ( VES ) that highlights the edges of the road ahead on driver 's behavior and overall safety , under normal and reduced visibility conditions .
-METHODS	Thirty drivers drove in a fix-based simulator through a winding rural road , while attempting to avoid un-enhanced and unexpected obstacles that appeared on the driving lane from time to time .
-METHODS	The simulated VES highlighted the road edges up to a distance of 90 m with two alternative configurations : two continuous red lines or a series of red crosses .
-METHODS	The effects of the two VES configurations on performance were measured during night and fog driving .
-METHODS	Performance measures included speed , lane keeping behavior , eye scanning pattern , reaction time ( RT ) and collisions with the un-enhanced unexpected obstacles .
-METHODS	Subjective measures included confidence and stress .
-RESULTS	With the VES , drivers were more confident , less stressed , and drove faster , but had almost twice as many collisions with the unexpected obstacles .
-RESULTS	Also , steering/braking RT to the obstacles was longer with the VES than without it by nearly 44 msec .
-CONCLUSIONS	The results are consistent with Lebowitz 's theory ( 1977 ) .
-CONCLUSIONS	While the VES enhanced spatial orientation , it fooled the drivers into assuming that the visibility of obstacles on the road was also improved , and thus actually reduced safety .
-CONCLUSIONS	When visibility is an issue in nighttime crashes , the site-specific crashes should be investigated , in cases of collision with objects-on-the-road , improved delineation should be ruled out .
-
-###26170351
-BACKGROUND	Pregabalin may reduce postoperative pain and opioid use .
-BACKGROUND	Higher doses may be more effective , but may cause sedation and confusion .
-BACKGROUND	This prospective , randomized , blinded , placebo-controlled study tested the hypothesis that pregabalin reduces pain at 2 weeks after total knee arthroplasty , but increases drowsiness and confusion .
-METHODS	Patients ( 30 per group ) received capsules containing pregabalin ( 0 , 50 , 100 , or 150 mg ) ; two capsules before surgery , one capsule twice a day until postoperative day ( POD ) 14 , one on POD15 , and one on POD16 .
-METHODS	Multimodal analgesia included femoral nerve block , epidural analgesia , oxycodone-paracetamol , and meloxicam .
-METHODS	The primary outcome was pain with flexion ( POD14 ) .
-RESULTS	Pregabalin did not reduce pain at rest , with ambulation , or with flexion at 2 weeks ( P = 0.69 , 0.23 , and 0.90 , respectively ) .
-RESULTS	Pregabalin increased POD1 drowsiness ( 34.5 , 37.9 , 55.2 , and 58.6 % in the 0 , 50 , 100 , and 150 mg arms , respectively ; P = 0.030 ) , but did not increase confusion ( 0 , 3.5 , 0 , and 3.5 % , respectively ; P = 0.75 ) .
-RESULTS	Pregabalin had no effect on acute or chronic pain , opioid consumption , or analgesic side-effects .
-RESULTS	Pregabalin reduced POD14 patient satisfaction [ 1-10 scale , median ( first quartile , third quartile ) : 9 ( 8 , 10 ) , 8 ( 7 , 10 ) , 8 ( 5 , 9 ) , and 8 ( 6 , 9.3 ) , respectively ; P = 0.023 ) .
-RESULTS	Protocol compliance was 63 % by POD14 ( 50.0 , 70.0 , 76.7 , and 56.7 % compliance , respectively ) , with no effect of dose on compliance .
-RESULTS	Per-protocol analysis of compliant patients showed no effect of pregabalin on pain scores .
-CONCLUSIONS	Pregabalin had no beneficial effects , but increased sedation and decreased patient satisfaction .
-CONCLUSIONS	This study does not support routine perioperative pregabalin for total knee arthroplasty patients .
-BACKGROUND	ClinicalTrials.gov : http://www.clinicaltrials.gov/ct2/show/study/NCT01333956 .
-
-###24382030
-BACKGROUND	Obstructive sleep apnea ( OSA ) and hypertension are well-known cardiovascular risk factors .
-BACKGROUND	Their control could reduce the burden of heart disease across populations .
-BACKGROUND	Several drugs are used to control hypertension , but the only consistently effective treatment of OSA is continuous positive airway pressure .
-BACKGROUND	The identification of a drug capable of improving OSA and hypertension simultaneously would provide a novel approach in the treatment of both diseases .
-METHODS	This is a randomized double-blind clinical trial , comparing the use of chlorthalidone with amiloride versus amlodipine as a first drug option in patients older than 40 years of age with stage I hypertension ( 140 to 159/90 to 99mmHg ) and moderate OSA ( 15 to 30 apneas/hour of sleep ) .
-METHODS	The primary outcomes are the variation of the number of apneas per hour and blood pressure measured by ambulatory blood pressure monitoring .
-METHODS	The secondary outcomes are adverse events , somnolence scale ( Epworth ) , ventilatory parameters and C reactive protein levels .
-METHODS	The follow-up will last 8 weeks .
-METHODS	There will be 29 participants per group .
-METHODS	The project has been approved by the ethics committee of our institution .
-CONCLUSIONS	The role of fluid retention in OSA has been known for several decades .
-CONCLUSIONS	The use of diuretics are well established in treating hypertension but have never been appropriately tested for sleep apnea .
-CONCLUSIONS	As well as testing the efficacy of these drugs , this study will help to understand the mechanisms that link hypertension and sleep apnea and their treatment .
-BACKGROUND	ClinicalTrials.gov : NCT01896661 .
-
-###25319951
-OBJECTIVE	The beneficial effect of rosuvastatin against percutaneous coronary intervention ( PCI ) related procedural myocardial injury has been determined mostly in patients with acute coronary syndromes ( ACS ) .
-OBJECTIVE	However , the detailed therapeutic mechanism has not been well studied .
-METHODS	Patients with ACS receiving PCI ( n = 159 ) were randomized to control group ( placebo treatment ) or to rosuvastatin group ( 20 mg 12 h before PCI , and a further 20 mg 2 h preprocedure dose ) .
-METHODS	Levels of INF - , TNF - , IL-6 , miR-155 / SHIP-1 , and CD4 ( + ) FoxP3 ( + ) Treg in peripheral blood were detected before PCI and 24 h after PCI .
-METHODS	Clinical data of these patients were also collected in this prospective study .
-RESULTS	Compared with placebo , rosuvastatin treatment significantly reduced the incidence of periprocedural myocardial infarction ( PMI ) and levels of cardiac troponin I ( cTnI ) associated with decreased relative expression of serum miR-155 , levels of inflammatory cytokines ( INF - , TNF - , and IL-6 ) , increased SHIP-1 expression and CD4 ( + ) FoxP3 ( + ) Treg percentage values ( P < 0.05 ) .
-RESULTS	In addition , patients with rosuvastatin pretreatment also reduced incidence of 30 days major adverse cardiac events ( MACE ) compared to the patients with placebo treatment ( 16 patients vs. 28 patients , P = 0.038 ) .
-CONCLUSIONS	Our study suggests that high loading dose rosuvastatin pretreatment may reduce the incidence of cardiovascular events and levels of inflammatory markers in patients with ACS receiving PCI , which may be explained at least in part , by mechanism involving suppression of miR-155 / SHIP-1 signaling pathway .
-
-###25469829
-OBJECTIVE	Adherence to insulin therapy can be threatened by pain and needle fear .
-OBJECTIVE	This cross-over randomized non-inferiority trial evaluated a new Pic Insupen 33G4mm needle vs. a 32G4mm needle in terms of metabolic control , safety and acceptability in patients with diabetes treated with insulin .
-METHODS	We used a centralized , permuted block randomization , stratified by center and maximum insulin dose per single injection .
-METHODS	Subjects used the two needles in two 3 week treatment periods .
-METHODS	The primary endpoint was the absolute percentage variation of the blood fructosamine between the two treatments ( % | Fru | ) .
-METHODS	Additional endpoints were : glycemic variability , total insulin doses , body weight , severe hypoglycemic episodes , leakage at injection sites and pain measured by visual analogue scale .
-METHODS	Equivalent glycemic control was defined a priori as % | Fru | ( including 95 % CI ) within 20 % .
-RESULTS	Of 87 subjects randomized , 77 completed the study ( median age 53.1 [ IR 42.3-61 .2 ] , median BMI 24.3 Kg/m ( 2 ) [ IR 21.3-28 .5 ] , median duration of insulin therapy [ in months ] 141.4 ( IR 56.3-256 .9 ) , median baseline HbA1c 7.9 % [ IR 7.2-8 .8 ] ) .
-RESULTS	The % | Fru | was 7.93 % ( 95 % CI 6.23-9 .63 ) , meeting the non-inferiority criterion .
-RESULTS	The fasting blood glucose standard deviation was 46.2 ( mean 154.6 ) with the 33G needle and 42.8 ( mean 157.3 ) with the 32G needle ( p = 0.42 ) .
-RESULTS	Insulin daily dose and patients ' weight did not show any statistically significant variation .
-RESULTS	We observed 95 episodes of symptomatic hypoglycemia with the 33G needle and 96 with the 32G needle .
-RESULTS	One episode of severe hypoglycemia was documented in the latter group .
-RESULTS	As for insulin leakage we observed 37.55 episodes per 100 patient-days with the 33G needle and 32.21 episodes per 100 patient-days with the 32G needle ( p = 0.31 ) .
-RESULTS	Patients reported less pain with the 33G4mm needle ( p = 0.05 ) .
-CONCLUSIONS	Study sample was mainly composed of adults with type 1 diabetes and study was not blinded .
-CONCLUSIONS	The 33G needle is not inferior to the 32G needle in terms of efficacy and safety , with reduced pain and no difference in insulin leakage .
-BACKGROUND	NCT01745549 .
-
-###24824050
-BACKGROUND	Pregnancy and the postpartum period present important intervention opportunities .
-BACKGROUND	Counseling can leverage the motivation women have during this time to change behaviors that may negatively affect their health and the heath of their infants .
-METHODS	Pregnant women attending an antenatal clinic in South Africa were randomly allocated to treatment ( n = 733 ) and control arms ( n = 747 ) .
-METHODS	Treatment arm participants received enhanced HIV pre - and post-test counseling , legal support and access to support groups at baseline , which occurred at the first antenatal visit , and then six and ten weeks postpartum .
-METHODS	Control arm participants received standard HIV testing and counseling ( HTC ) and two postpartum attention control sessions .
-METHODS	Outcomes were incidence of sexually transmitted infection ( STI ) by 14 weeks postpartum and past 30-day inconsistent condom use at 14 weeks and 9 months postpartum .
-RESULTS	There were no intervention effects on incident STIs for either HIV-negative ( adjusted risk ratio ( aRR ) 1.01 , 95 % CI 0.71-1 .44 ) or HIV-positive participants ( aRR 0.86 , 95 % CI 0.61-1 .23 ) .
-RESULTS	The intervention was associated with a 28 % decrease in risk of past 30-day inconsistent condom use at nine-months among HIV-negative women ( aRR 0.72,95 % CI 0.59-0 .88 ) , but did not affect inconsistent condom use among HIV-positive women ( aRR1 .08 ; 95 % CI 0.67-1 .75 ) .
-CONCLUSIONS	An enhanced counseling intervention during pregnancy and the postpartum period can lead to reductions in inconsistent condom use among HIV-negative women .
-CONCLUSIONS	Results underscore the importance of the counseling that accompanies HIV HTC .
-CONCLUSIONS	More work is needed to understand how to promote and sustain risk reduction among HIV-positive women .
-BACKGROUND	ClinicalTrials.gov NCT01683461 .
-
-###24602923
-OBJECTIVE	Simeprevir is an oral , once-daily inhibitor of hepatitis c virus ( HCV ) protease NS3/4A .
-OBJECTIVE	We investigated the safety and efficacy of simeprevir with peg-interferon -2 a and ribavirin ( PR ) in a randomized , double-blind , placebo-controlled , phase 3 trial of patients with HCV genotype 1 infection who relapsed after previous interferon-based therapy .
-METHODS	Patients were assigned randomly ( 2:1 ) to groups given simeprevir ( 150 mg , once daily ) and PR ( n = 260 ) or placebo and PR ( n = 133 ) for 12 weeks .
-METHODS	Patients then were given PR alone for 12 or 36 weeks ( simeprevir group , based on response-guided therapy criteria ) or 36 weeks ( placebo group ) .
-RESULTS	Simeprevir and PR was significantly superior to placebo and PR ; rates of sustained virologic response 12 weeks after planned end of treatment ( SVR12 ) were 79.2 % vs 36.1 % , respectively ( 43.8 % difference ; 95 % confidence interval , 34.6-53 .0 ; P < .001 ) .
-RESULTS	Among patients given simeprevir , 92.7 % met the response-guided therapy criteria and were eligible to complete PR at week 24 ; of these , 83.0 % achieved SVR12 .
-RESULTS	HCV RNA was undetectable at week 4 in 77.2 % of patients given simeprevir and 3.1 % given placebo .
-RESULTS	On-treatment failure and relapse rates were lower among patients given simeprevir and PR than those given placebo and PR ( 3.1 % vs 27.1 % , and 18.5 % vs 48.4 % , respectively ) .
-RESULTS	Patients given simeprevir did not have adverse events beyond those that occurred in patients given PR alone .
-RESULTS	Most adverse events were grades 1/2 ; the prevalence of anemia and rash was similar in both groups .
-RESULTS	Patients in both groups reported similar severity of fatigue and functional impairments during the study , but duration was reduced among patients given simeprevir .
-CONCLUSIONS	In a phase 3 trial of patients who had relapsed after interferon-based therapy , the addition of simeprevir to PR was generally well tolerated , with an SVR12 rate of 79.2 % .
-CONCLUSIONS	Most patients ( 92.7 % ) receiving simeprevir were able to shorten therapy to 24 weeks .
-CONCLUSIONS	ClinicalTrials.gov number : NCT01281839 .
-
-###24641841
-BACKGROUND	Due to physical characteristics , ions like protons or carbon ions can administer the dose to the target volume more efficiently than photons since the dose can be lowered at the surrounding normal tissue .
-BACKGROUND	Radiation biological considerations are based on the assumption that the / value for prostate cancer cells is 1.5 Gy , so that a biologically more effective dose could be administered due to hypofractionation without increasing risks of late effects of bladder ( / = 4.0 ) and rectum ( / = 3.9 ) .
-METHODS	The IPI study is a prospective randomized phase II study exploring the safety and feasibility of primary hypofractionated irradiation of the prostate with protons and carbon ions in a raster scan technique .
-METHODS	The study is designed to enroll 92 patients with localized prostate cancer .
-METHODS	Primary aim is the assessment of the safety and feasibility of the study treatment on the basis of incidence grade III and IV NCI-CTC-AE ( v. 4.02 ) toxicity and/or the dropout of the patient from the planned therapy due to any reason .
-METHODS	Secondary endpoints are PSA-progression free survival ( PSA-PFS ) , overall survival ( OS ) and quality-of-life ( QoL ) .
-CONCLUSIONS	This pilot study aims at the evaluation of the safety and feasibility of hypofractionated irradiation of the prostate with protons and carbon ions in prostate cancer patients in an active beam technique .
-CONCLUSIONS	Additionally , the safety results will be compared with Japanese results recently published for carbon ion irradiation .
-CONCLUSIONS	Due to the missing data of protons in this hypofractionated scheme , an in depth evaluation of the toxicity will be created to gain basic data for a following comparison study with carbon ion irradiation .
-BACKGROUND	Clinical Trial Identifier : NCT01641185 ( clinicaltrials.gov ) .
-
-###24385269
-OBJECTIVE	High rates of ischemic stroke and poor adherence to secondary prevention measures are observed in the Chinese population .
-METHODS	We used a national , multicenter , cluster-randomized controlled trial in which 47 hospitals were randomized to either a structured care program group ( n = 23 ) or a usual care group ( n = 24 ) .
-METHODS	The structured care program consisted of a specialist-administered , guideline-recommended pharmaceutical treatment and a lifestyle modification algorithm associated with written and Internet-accessed educational material for patients for the secondary prevention of ischemic stroke .
-METHODS	The primary efficacy outcome was the proportion of patients who adhered to the recommended measures at 12-month postdischarge .
-METHODS	This trial is registered with ClinicalTrial.gov ( NCT00664846 ) .
-RESULTS	At 12 months , 1287 ( 72.1 % ) patients in the Standard Medical Management in Secondary Prevention of Ischemic Stroke in China ( SMART ) group and 1430 ( 72 % ) patients in the usual care group had completed the 12-month follow-up ( P = 0.342 ) .
-RESULTS	Compared with the usual care group , those in the SMART group showed higher adherence to statins ( 56 % versus 33 % ; P = 0.006 ) but no difference in adherence to antiplatelet ( 81 % versus 75 % ; P = 0.088 ) , antihypertensive ( 67 % versus 69 % ; P = 0.661 ) , or diabetes mellitus drugs ( 73 % versus 67 % ; P = 0.297 ) .
-RESULTS	No significant difference in the composite end point ( new-onset ischemic stroke , hemorrhagic stroke , acute coronary syndrome , and all-cause death ) was observed ( 3.56 % versus 3.59 % ; P = 0.921 ) .
-CONCLUSIONS	The implementation of a program to improve adherence to secondary ischemic stroke prevention efforts in China is feasible , but these programs had only a limited impact on adherence and no impact on 1-year outcomes .
-CONCLUSIONS	Further development of a structured program to reduce vascular events after stroke is needed .
-CONCLUSIONS	Clinical Trial Registration-URL : http://www.clinicaltrials.gov .
-CONCLUSIONS	Unique identifier : NCT00664846 .
-
-###24873162
-OBJECTIVE	To compare the effect of transumbilical single-site single-port with that of transumbilical single-site double-port laparoscopic varicocelectomy in the treatment of varicocele in adolescents .
-METHODS	We randomly assigned 80 varicocele patients aged 10 - 16 years to two groups of equal number to receive transumbilical single-site single-port and single-site double-port laparoscopic varicocelectomy , respectively .
-METHODS	We compared the operation time , postoperative hospital stay , incisional pain , complications and satisfaction with the abdominal cosmetic outcomes between the two groups .
-RESULTS	All the operations were successfully performed .
-RESULTS	The double-port group showed a significantly higher score on the Visual Analogue Scale than the single-port group ( 4.8 + / - 1.4 vs 3.6 + / - 1.1 , t = -4.986 , P < 0.01 ) , but there were no significant differences between the two groups in the operation time ( [ 29.8 + / - 4.2 ] vs [ 31.2 + / - 4.6 ] min , t = 1.383 , P = 0.171 ) , postoperative hospital stay ( [ 1.95 + / - 0.7 ] vs [ 1.82 + / - 0.8 ] d , t = -0.784 , P = 0.436 ) , complications ( 0 vs 0 ) and scores on the satisfaction with abdominal cosmetic outcomes ( 4.6 + / - 0.6 vs 4.8 + / - 0.5 , t = 1.253 , P = 0.214 ) .
-RESULTS	No recurrence , umbilical hernia , hydrocele and orchiatrophy were found in the two groups of patients at 6 months after operation , and no visible scar was observed on the abdominal surface .
-CONCLUSIONS	With strict surgical indications , single-site single-port and single-site double-port laparoscopic varicocelectomies have similar clinical effects in the treatment of varicocele , which leave no scar on the abdominal surface .
-CONCLUSIONS	Single-site double-port laparoscopy needs no special instruments and therefore is worthier of wide clinical application .
-
-###25099167
-BACKGROUND	Clinical decision rules ( CDRs ) can be an effective tool for knowledge translation in emergency medicine , but their implementation is often a challenge .
-BACKGROUND	This study examined whether the Theory of Planned Behaviour ( TPB ) could help explain the inconsistent results between the successful Canadian C-Spine Rule ( CCR ) implementation study and unsuccessful Canadian CT Head Rule ( CCHR ) implementation study .
-BACKGROUND	Both rules are aimed at improving the accuracy and efficiency of emergency department radiography use in clinical contexts that exhibit enormous inefficiency at the present time .
-BACKGROUND	The rules were prospectively derived and validated using the same methodology demonstrating high sensitivity and reliability .
-BACKGROUND	The rules subsequently underwent parallel implementations at 12 Canadian hospitals , yet only the CCR was observed to significantly reduce radiography ordering rates , while the CCHR failed to have any significant impact at all .
-BACKGROUND	The drastically different results are unlikely to be the result of differences in implementation strategies or the decision rules .
-METHODS	Physicians at the 12 participating Canadian hospitals were randomized to CCR or CCHR TPB surveys that were administered during the baseline phases of the implementation studies , before any intervention had taken place .
-METHODS	The collected baseline survey data were linked to concurrent baseline physician and patient-specific imaging data , and subsequently analyzed using mixed effects linear and logistic models .
-RESULTS	A total of 223 of the 378 eligible physicians randomized to a TPB survey completed their assigned baseline survey ( CCR : 122 of 181 ; CCHR : 101 of 197 ) .
-RESULTS	Attitudes were significantly associated with intention in both settings ( CCR : = 0.40 ; CCHR : = 0.30 ) , as were subjective norms ( CCR : = 0.26 ; CCHR : = 0.73 ) .
-RESULTS	Intention was significantly associated with actual image ordering for CCR ( OR = 1.79 ) , but not CCHR .
-CONCLUSIONS	The TPB can be used to better understand processes underlying use of CDRs .
-CONCLUSIONS	TPB constructs were significantly associated with intention to perform both imaging behaviours , but intention was only associated with actual behaviour for CCR , suggesting that constructs outside of the TPB framework may need to be considered when seeking to understand use of CDRs .
-
-###25233649
-OBJECTIVE	To compare the efficacy difference of analgesia and detumescence on ankle sprain among acupuncture at Xiaojie point combined with tendon regulation manipulation , acupuncture at Xiaojie point and tendon regulation manipulation .
-METHODS	Sixty cases of ankle sprain were randomized into a combined therapy group , a Xiaojie point group and a tendon-regulation manipulation group , 20 cases in each one .
-METHODS	The combined therapy of acupuncture at Xiaojie point and tendon regulation manipulation , the acupuncture at Xiaojie point and the simple application of tendon-regulation manipulation were applied respectively in the three groups , once a day , 3 treatments were required .
-METHODS	The symptom score such as pain , ecchymosis , swelling and motor dysfunction and the total score were observed before and after treatment in the three groups .
-METHODS	The different values of pain and swelling scores were compared before and after treatment in the three groups .
-METHODS	The efficacy was compared among the groups .
-RESULTS	The total effective rate was 100.0 % ( 20/20 ) in each group .
-RESULTS	But the curative rate was 85.0 % ( 17/20 ) in the combined group , 65.0 % ( 13/20 ) in the Xiaojie point tion manipulation group .
-RESULTS	After treatment , the symptom scores of pain , ecchymosis , swelling and motor dysfunction and the total score were all improved as compared with those before treatment in the three groups ( P < 0.01 , P < 0.05 ) .
-RESULTS	The pain score in either the combined therapy group or Xiaojie point group was lower than that in the tendon-regulation manipulation group after treatment ( 0.20 - / + 0.41 , 0.15 + / - 0.37 vs 0.60 + / - 0.50 , both P < 0.05 ) .
-RESULTS	Swelling score in the Xiaojie point group was different significantly from that in the tendon-regulation manipulation 0.49 vs 06.4 vs. 20 +0.41 , P < 0.05 ) .
-RESULTS	The different value of pain score in either the combined therapy group or Xiaojie point group was higher than that in the tendon-regulation manipulation group before group after treatment ( 0.65 bined therapy group or Xiaojie point group was higher than that in the tendon-regulation manipulation group before and after treatment ( 2.35 + / - 0.59 , 2.45 + / - 0.51 vs 2.00 + / - 0.46 , both P < 0.05 ) .
-RESULTS	The different value of swelling score in the tendon-regulation manipulation group was higher than that in the Xiaojie point group before and after treatment ( 2.30 + / - 0.57 vs 1.60 + / - 0.60 , P < 0.05 ) .
-CONCLUSIONS	Acupuncture at Xiaojie point combined with tendon-regulation manipulation achieve an apparent effect of analgesia and detumescence on ankle sprain .
-
-###25413071
-OBJECTIVE	To explore the clinical efficacy and safety of the early use of urokinase in the prevention and treatment on tunneled hemodialysis catheter related fibrin sheaths .
-METHODS	Thirty-eight hemodialysis patients with tunneled central venous catheter and good catheter function were randomly divided into experimental group and control group .
-METHODS	Urokinase was given after 3 days of indwelling catheter in the experimental group and after the onset of catheter dysfunction in the control group .
-METHODS	The catheter function , mean blood flow and venous pressure of dialysis , coagulation , and side effects in the two groups were observed for 6 months .
-RESULTS	The rates of catheter dysfunction on the arterial side were 0.65 % and 2.71 % in the experimental group and control group , respectively ( P < 0.05 ) , with catheter dysfunction rates on the vein side of 0.92 % and 2.41 % , respectively ( P < 0.05 ) .
-RESULTS	Catheter dysfunction occurred for the first time at 87.9 24.1 days in the experimental group , and at 31.3 11.5 days in the control group ( P < 0.05 ) .
-RESULTS	The mean blood flow showed no significant difference between the two groups at 1 month after tube insertion ( P > 0.05 ) , but was higher in the experimental group at 3 and 6 months after the tube insertion ( P < 0.05 ) .
-RESULTS	The mean venous pressure in two groups was similar 1 and 3 months after tube insertion ( P > 0.05 ) , but was significantly lower in the experimental group at 6 months ( P < 0.05 ) .
-RESULTS	Compared with control group , the experimental group showed significantly prolonged prothrombin time ( P < 0.05 ) but similar rest coagulation parameters .
-RESULTS	No serious drug-related side effects occurred in these two groups .
-CONCLUSIONS	Early use of urokinase is safe and effective for prevention and treatment of tunneled hemodialysis catheter-related fibrin sheaths with minimal side effects .
-
-###24722047
-BACKGROUND	Therapeutic ultrasound and transcutaneous electrical nerve stimulation ( TENS ) have been described as being effective in the treatment of spasticity .
-BACKGROUND	No previous study compared these physical modalities with a first-line treatment for spasticity , such as botulinum toxin type A.
-OBJECTIVE	To compare the effects of therapeutic ultrasound and TENS with botulinum toxin type A on spasticity after stroke .
-METHODS	Thirty patients with chronic stroke and spastic equinus were randomly assigned to 3 groups : 1 group received therapeutic ultrasound to the affected leg calf muscles , 1 group underwent TENS to the tibial nerve of the affected leg , and 1 group was injected with onabotulinum toxin A in the spastic gastrocnemius .
-METHODS	All patients were evaluated immediately before treatment and 15 , 30 , and 90 days after the first clinical evaluation .
-METHODS	The following outcome measures were considered : ankle passive dorsiflexion range of motion and the modified Ashworth scale .
-RESULTS	Patients injected with botulinum toxin type A had significantly better ankle passive range of motion than those treated with physical modalities at all posttreatment evaluations .
-RESULTS	At second and third posttreatment evaluations , the modified Ashworth scale indicated significantly greater improvement in patients injected with botulinum toxin type A than in those treated with physical modalities .
-RESULTS	No difference was found between groups treated with physical modalities .
-CONCLUSIONS	Our findings support the hypothesis that botulinum toxin type A is more effective than therapeutic ultrasound and TENS for treating focal spasticity in patients with chronic stroke .
-
-###25638326
-BACKGROUND	GOG 240 was a practice-changing randomised phase 3 trial that concluded that chemotherapy plus bevacizumab for advanced cervical cancer significantly improves overall and progression-free survival , and the proportion of patients achieving an overall objective response , compared with chemotherapy alone .
-BACKGROUND	In this study , we aimed to analyse patient-reported outcomes in GOG 240 .
-METHODS	Eligible adult participants ( aged 18 years ) had primary stage IVB or recurrent or persistent carcinoma of the cervix with measurable disease and GOG performance status of 0-1 .
-METHODS	Participants were randomly assigned by web-based permuted block randomisation ( block size 4 ) in a 1:1:1:1 ratio to the four treatment groups : cisplatin ( 50 mg/m ( 2 ) intravenously on day 1 or 2 of the treatment cycle ) and paclitaxel ( 135 mg/m ( 2 ) intravenously over 24 h or 175 mg/m ( 2 ) intravenously over 3 h on day 1 ) , with or without bevacizumab ( 15 mg/kg intravenously on day 1 or 2 ) , or paclitaxel ( 175 mg/m ( 2 ) over 3 h on day 1 ) and topotecan ( 075 mg/m ( 2 ) for 30 min on days 1-3 ) with or without bevacizumab ( 15 mg/kg intravenously on day 1 ) .
-METHODS	Treatment assignment was concealed at randomisation ( everyone was masked to treatment assignment , achieved by the use of a computer encrypted numbering system at the National Cancer Institute ) and became open-label when each patient was registered to the trial .
-METHODS	Treatment cycles were repeated every 21 days until disease progression or unacceptable toxicity , whichever occurred first .
-METHODS	The coprimary endpoints of the trial were overall survival and safety ; the primary quality-of-life endpoint was the score on the Functional Assessment of Cancer Therapy-Cervix Trial Outcome Index ( FACT-Cx TOI ) .
-METHODS	For our analysis of patient-reported outcomes , participants were assessed before treatment cycles 1 , 2 , and 5 , and at 6 and 9 months after the start of cycle 1 , with the FACT-Cx TOI , items from the FACT-GOG-Neurotoxicity subscale , and a worst pain item from the Brief Pain Inventory .
-METHODS	All patients who completed baseline quality-of-life assessments and at least one further follow-up assessment were evaluable for quality-of-life outcomes .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT00803062 .
-RESULTS	Between April 6 , 2009 , and Jan 3 , 2012 , a total of 452 patients were enrolled in the trial , of whom 390 completed baseline quality-of-life assessment and at least one further assessment and were therefore evaluable for quality-of-life outcomes .
-RESULTS	In these patients , patient-reported outcome completion declined from 426 ( 94 % ) of 452 ( at baseline ) to 193 ( 63 % ) of 307 ( 9 months post-cycle 1 ) , but completion rates did not differ significantly between treatment regimens ( p = 078 ) .
-RESULTS	The baseline FACT-Cx TOI scores did not differ significantly between patients who received bevacizumab versus those who did not ( p = 027 ) .
-RESULTS	Compared with patients who received chemotherapy alone , patients who received chemotherapy plus bevacizumab reported FACT-Cx TOI scores that were an average of 12 points lower ( 9875 % CI -41 to 17 ; p = 030 ) .
-CONCLUSIONS	Improvements in overall survival and progression-free survival attributed to the incorporation of bevacizumab into the treatment of advanced cervical cancer were not accompanied by any significant deterioration in health-related quality of life .
-CONCLUSIONS	Patients responding to anti-angiogenesis therapy who maintain an acceptable quality of life could be suitable at progression for treatment with other novel therapies that might confer additional benefit .
-BACKGROUND	National Institutes of Health .
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-###24308282
-BACKGROUND	Multimorbid patients frequently receive complex medication regimens and are at higher risk for adverse drug reactions and hospitalisations .
-BACKGROUND	Managing patients with polypharmacy is demanding , because it requires coordination of multiple prescribers and intensive monitoring .
-BACKGROUND	Three evidence-based recommendations addressing polypharmacy in primary care are structured medication counselling , use of medication lists and medication reviews to avoid potentially inappropriate medication ( PIM ) .
-BACKGROUND	Although promising to improve patient outcomes , these recommendations are not well implemented in German routine care .
-BACKGROUND	Implementation of guidelines is often hindered by specific `` determinants of change '' .
-BACKGROUND	`` Tailored '' interventions are designed to specifically address previously identified determinants .
-BACKGROUND	This study examines a tailored intervention to implement the aforementioned recommendations into German primary care practices .
-BACKGROUND	This study is part of the European Tailored Interventions for Chronic Diseases project , which aims at contributing knowledge about the methods used for tailoring .
-METHODS	The study is designed as a cluster randomized controlled trial with primary care practices of general practitioners ( GPs ) who are organized in quality circles .
-METHODS	Quality circles will be the unit of randomization with a 1:1 ratio .
-METHODS	Follow-up time is 6 months .
-METHODS	GPs and healthcare assistants in the intervention group will receive training on medication management .
-METHODS	Each GP will create a tailored concept of how to implement the three recommendations into his/her practice .
-METHODS	Evidence-based checklists for medication counselling and medication reviews will be provided for physicians .
-METHODS	A tablet PC with an interactive educational tool and information leaflets will be provided for use by patients to inform about the necessity of continuous medication management .
-METHODS	Control practices will not receive special training and will provide care as usual .
-METHODS	Primary outcome is the degree of implementation of the three recommendations , which will be measured using a prespecified set of indicators .
-METHODS	Additionally , the PIM prescription rate , patient activation , patients ' beliefs about medicine , medication adherence and patients ' social support will be measured .
-CONCLUSIONS	This study will contribute knowledge about the feasibility of implementing recommendations for managing patients with polypharmacy in primary care practices .
-CONCLUSIONS	Additionally , this study will contribute knowledge about methods for tailoring of implementation interventions .
-BACKGROUND	Clinicaltrials.gov ISRCTN34664024 .
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-###25474535
-OBJECTIVE	This trial evaluated the efficacy of acetaminophen in reducing oxidative injury , as measured by plasma F2-isoprostanes , in adult patients with severe sepsis and detectable plasma cell-free hemoglobin .
-METHODS	Single-center , randomized , double-blind , placebo-controlled phase II trial .
-METHODS	Medical ICU in a tertiary , academic medical center .
-METHODS	Critically ill patients 18 years old or older with severe sepsis and detectable plasma cell-free hemoglobin .
-METHODS	Patients were randomized 1:1 to enteral acetaminophen 1 g every 6 hours for 3 days ( n = 18 ) or placebo ( n = 22 ) with the same dosing schedule and duration .
-RESULTS	F2-Isoprostanes on study day 3 , the primary outcome , did not differ between acetaminophen ( 30 pg/mL ; interquartile range , 24-41 ) and placebo ( 36 pg/mL ; interquartile range , 25-80 ; p = 0.35 ) .
-RESULTS	However , F2-isoprostanes were significantly reduced on study day 2 in the acetaminophen group ( 24 pg/mL ; interquartile range , 19-36 ) when compared with placebo ( 36 pg/mL ; interquartile range , 23-55 ; p = 0.047 ) .
-RESULTS	Creatinine on study day 3 , a secondary outcome , was significantly lower in the acetaminophen group ( 1.0 mg/dL ; interquartile range , 0.6-1 .4 ) when compared with that in the placebo ( 1.3 mg/dL ; interquartile range , 0.83-2 .0 ; p = 0.039 ) .
-RESULTS	There was no statistically significant difference in hospital mortality ( acetaminophen 5.6 % vs placebo 18.2 % ; p = 0.355 ) or adverse events ( aspartate aminotransferase or alanine aminotransferase > 400 ; acetaminophen 9.5 % vs placebo 4.3 % ; p = 0.599 ) .
-CONCLUSIONS	In adults with severe sepsis and detectable plasma cell-free hemoglobin , treatment with acetaminophen within 24 hours of ICU admission may reduce oxidative injury and improve renal function .
-CONCLUSIONS	Additional study is needed to confirm these findings and determine the effect of acetaminophen on patient-centered outcomes .
-
-###25458411
-OBJECTIVE	To explore knowledge and use of female condoms in China , and to compare four modes of failure between the Phoenurse female condom ( PFC ) and the second-generation Femidom female condom ( FC2 ) .
-METHODS	In a randomized , crossover trial , sexually active women aged 20-49years who attended a family planning service in Qingdao , China , were recruited between April and October , 2013 .
-METHODS	A computer-generated randomized sequence was used to assign participants ( 1:1 ) to group A ( used 10 PFCs followed by 10 FC2s ) or group B ( used 10 FC2s followed by 10 PFCs ) .
-METHODS	Study investigators and participants were masked to allocation .
-METHODS	Participants completed questionnaires at baseline and after using the two types of FCs .
-METHODS	They also kept coital logs .
-RESULTS	At baseline , 30 ( 10.3 % ) of 290 participants understood female condoms , but only 1 ( 0.3 % ) had ever used one .
-RESULTS	Total failure rates were 3.6 % ( 420/11 578 ) and 2.3 % ( 265/11 594 ) for PFC and FC2 , respectively ( P < 0.001 ) .
-RESULTS	Slippage was the most common form of failure , affecting 6.9 % of PFC uses and 5.0 % of FC2 uses .
-RESULTS	Breakage , misdirection , and slippage were significantly more common with the PFC than with the FC2 ( P0 .002 ) .
-CONCLUSIONS	Understanding of female condoms is poor in China .
-CONCLUSIONS	Failure is more common with the PFC than with the FC2 .
-
-###24888818
-OBJECTIVE	Increased circulating tumor cells ( CTCs ; five or more CTCs per 7.5 mL of whole blood ) are associated with poor prognosis in metastatic breast cancer ( MBC ) .
-OBJECTIVE	A randomized trial of patients with persistent increase in CTCs tested whether changing chemotherapy after one cycle of first-line chemotherapy would improve the primary outcome of overall survival ( OS ) .
-METHODS	Patients with MBC who did not have increased CTCs at baseline remained on initial therapy until progression ( arm A ) .
-METHODS	Patients with initially increased CTCs that decreased after 21 days of therapy remained on initial therapy ( arm B ) .
-METHODS	Patients with persistently increased CTCs after 21 days of therapy were randomly assigned to continue initial therapy ( arm C1 ) or change to an alternative chemotherapy ( arm C2 ) .
-RESULTS	Of 595 eligible and evaluable patients , 276 ( 46 % ) did not have increased CTCs ( arm A ) .
-RESULTS	Of those with initially increased CTCs , 31 ( 10 % ) were not retested , 165 were assigned to arm B , and 123 were randomly assigned to arm C1 or C2 .
-RESULTS	No difference in median OS was observed between arm C1 and C2 ( 10.7 and 12.5 months , respectively ; P = .98 ) .
-RESULTS	CTCs were strongly prognostic .
-RESULTS	Median OS for arms A , B , and C ( C1 and C2 combined ) were 35 months , 23 months , and 13 months , respectively ( P < .001 ) .
-CONCLUSIONS	This study confirms the prognostic significance of CTCs in patients with MBC receiving first-line chemotherapy .
-CONCLUSIONS	For patients with persistently increased CTCs after 21 days of first-line chemotherapy , early switching to an alternate cytotoxic therapy was not effective in prolonging OS .
-CONCLUSIONS	For this population , there is a need for more effective treatment than standard chemotherapy .
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-###24299553
-BACKGROUND	Oral contraceptives ( OC ) are effective for birth control and have good cycle control and tolerability .
-BACKGROUND	However , the hormonal components could modify mood and libido .
-OBJECTIVE	The aim of this study is to evaluate the genital vascular effects and sexual behavior of an OC containing 30 g ethinyl estradiol and 3 mg drospirenone in comparison with a flexible combined contraceptive vaginal ring .
-METHODS	Forty women underwent a sonographic assessment of the clitoral anatomy and vascularization and were administered the McCoy Female Sexuality Questionnaire ( MFSQ ) and the Beck 's Depression Inventory questionnaire ( BDI ) .
-METHODS	Estradiol , androstenedione , testosterone , and SHBG were assayed .
-METHODS	Free Androgen Index ( FAI ) and Free Estrogen Index ( FEI ) were calculated .
-METHODS	The patients were randomly submitted to OC ( group I ; n = 21 ) or vaginal ring ( group II ; n = 19 ) .
-METHODS	Ultrasonographic clitoral volume , pulsatility index ( PI ) of dorsal clitoral arteries , MFSQ , BDI , and hormonal and biochemical assays were analyzed .
-RESULTS	After therapy , the testosterone levels were reduced in both groups , whereas estradiol decreased only in group I women .
-RESULTS	The SHBG increased in all the subjects , and both FAI and FEI decreased .
-RESULTS	The clitoral volume decreased in all the women .
-RESULTS	The PI of the dorsal clitoral artery increased only in patients on OC .
-RESULTS	The hormonal contraception was associated , in both studied groups , with a significant decrease of the two-factor Italian MFSQ score , which was more marked in OC users .
-RESULTS	In group I subjects , there was a reduction of the number of intercourse/week and a reduction of orgasm frequency during intercourse .
-RESULTS	The pain during intercourse worsened after OC use .
-RESULTS	The vaginal ring users reported a vaginal wetness .
-CONCLUSIONS	Six-month treatment with hormonal contraception is associated with a diminished MFSQ score .
-CONCLUSIONS	However , the frequency of sexual intercourse and orgasm was reduced only by the use of OC .
-CONCLUSIONS	The OC use was associated with increased pain during intercourse .
-
-###25442690
-BACKGROUND	In 2002-04 , we did a randomised controlled trial in southern Nepal , and reported that children born to mothers taking multiple micronutrient supplements during pregnancy had a mean birthweight 77 g greater than children born to mothers taking iron and folic acid supplements .
-BACKGROUND	Children born to mothers in the study group were a mean 204 g heavier at 25 years of age and their systolic blood pressure was a mean 25 mm Hg lower than children born to mothers in the control group .
-BACKGROUND	We aimed to follow up the same children to mid-childhood ( age 85 years ) to investigate whether these differences would be sustained .
-METHODS	For this follow-up study , we identified children from the original trial and measured anthropometry , body composition with bioelectrical impedance ( with population-specific isotope calibration ) , blood pressure , and renal dimensions by ultrasound .
-METHODS	We documented socioeconomic status , household food security , and air pollution .
-METHODS	Main outcomes of the follow-up at 8 years were Z scores for weight-for-age , height-for-age , and body-mass index ( BMI ) - for-age according to WHO Child Growth Standards for children aged 5-19 years , and blood pressure .
-METHODS	This study is registered with the International Standard Randomised Controlled Trial register , number ISRCTN88625934 .
-RESULTS	Between Sept 21 , 2011 , and Dec 7 , 2012 , we assessed 841 children ( 422 in the control group and 419 in the intervention group ) .
-RESULTS	Unadjusted differences ( intervention minus control ) in Z scores were 005 for weight-for-age ( 95 % CI -009 to 019 ) , 002 in height-for-age ( -010 to 015 ) , and 004 in BMI-for-age ( -009 to 018 ) .
-RESULTS	We recorded no difference in blood pressure .
-RESULTS	Adjusted differences were similar for all outcomes .
-CONCLUSIONS	We recorded no differences in phenotype between children born to mothers who received antenatal multiple micronutrient or iron and folate supplements at age 85 years .
-CONCLUSIONS	Our findings did not extend to physiological differences or potential longer-term effects .
-BACKGROUND	The Wellcome Trust .
-
-###24574085
-BACKGROUND	Nasal saline irrigation is a safe treatment for chronic rhinosinusitis ; however , its effect on olfaction is unclear .
-BACKGROUND	Cyclic adenosine monophosphate ( cAMP ) is a key second messenger in the mechanism of olfaction and has been shown to be associated with smell function .
-BACKGROUND	In animal studies , olfactory cilia may be harvested by simple saline preparations .
-BACKGROUND	This study aimed to characterize the effect of nasal saline irrigation on smell function .
-METHODS	Volunteers with normal olfaction were randomized into a control or irrigation cohort .
-METHODS	In the initial appointment , subjects completed a University of Pennsylvania Smell Identification Test ( UPSIT ) and nasal samples were obtained by 2 methods : the nasal curette and cytobrush .
-METHODS	The irrigation cohort performed daily nasal saline irrigations .
-METHODS	Both cohorts then returned in 1 week .
-METHODS	The UPSIT and nasal cell collection were repeated , and each subject completed a subjective olfactory transition scale .
-METHODS	Nasal samples were processed for cAMP levels using a commercial assay .
-RESULTS	Thirty-two subjects were enrolled and randomized into each cohort .
-RESULTS	Control and postirrigation mean UPSIT scores were 36.8 and 36.7 ( p = 0.48 ) .
-RESULTS	No subjects reported a subjective smell loss .
-RESULTS	Ten pairs of nasal samples were assayed .
-RESULTS	Using the curette , control and postirrigation cAMP levels were 509 and 490 fmol / ( mg/mL ) , respectively ( p = 0.94 ) .
-RESULTS	Using the cytobrush , respective cAMP levels were 424 and 449 fmol / ( mg/mL ) , respectively ( p = 0.94 ) .
-CONCLUSIONS	Nasal saline irrigation has no subjective or objective effect on olfaction .
-CONCLUSIONS	It also does not appear to affect cAMP levels , a potential marker of smell function .
-
-###25516462
-OBJECTIVE	To compare two electrosurgical techniques , straight-wire excision of transformation zone ( SWETZ ) with large loop excision of transformation zone , as a cone procedure ( LLETZ-cone ) , for the treatment of cervical intraepithelial neoplasia ( CIN ) , when disease is present at the cervical canal .
-METHODS	Randomised controlled trial .
-METHODS	Two public hospitals , one in Rio de Janeiro , Brazil and one in Dublin , Ireland .
-METHODS	One hundred and three women with indication to treat CIN located at cervical canal .
-METHODS	Women were randomised to receive LLETZ-cone or SWETZ .
-RESULTS	Main outcome was the incidence of complete excision of disease at endocervical margin of the surgical specimen .
-RESULTS	Secondary outcomes were complete excision at ectocervical and stromal margins , time to complete the procedure , specimen fragmentation , blood loss and death after 1 year .
-RESULTS	Fifty-two women were allocated to LLETZ-cone and 51 to SWETZ .
-RESULTS	Ten women were lost for main outcome because of damaged specimens .
-RESULTS	Forty-two women in the LLETZ-cone group had free endocervical margin versus 43 women in the SWETZ group ( relative risk 1.04 , 95 % confidence interval [ 95 % CI ] 0.87-1 .25 ; P = 0.64 ) .
-RESULTS	For secondary outcomes related to margins , we observed a relative risk of 1.15 ( 95 % CI 0.95-1 .39 ; P = 0.15 ) for ectocervical free margin .
-RESULTS	For free stromal margin , the relative risk was 1.07 ( 95 % CI 0.89-1 .29 ; P = 0.47 ) .
-RESULTS	No death was observed .
-CONCLUSIONS	This study was inconclusive ; SWETZ and LLETZ-cone were equally effective to treat endocervical disease , with no difference in protecting against margin involvement .
-CONCLUSIONS	Higher , but not severe , blood loss and longer surgical time were observed in the SWETZ group .
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-###25580087
-BACKGROUND	Tissue hypoperfusion occurs frequently during surgery and may contribute to postoperative organ dysfunction .
-BACKGROUND	There is a need for perioperative treatment protocols aiming at improving tissue oxygenation ( StO2 ) .
-BACKGROUND	We hypothesised that intra-operative optimisation of StO2 improves tissue perfusion and thus reduces postoperative complications .
-BACKGROUND	Furthermore , we evaluated the feasibility of the optimisation algorithm used .
-METHODS	We randomized 50 high-risk patients , all > 65 years with ASA physical status III , who underwent major abdominal surgery under standardized balanced general anesthesia combined with epidural analgesia .
-METHODS	Throughout surgery StO2 was monitored at the thenar eminence using near-infrared spectroscopy .
-METHODS	All patients were treated according to a standard care algorithm .
-METHODS	In addition , patients in the intervention group were treated with dobutamine if necessary to keep or raise StO280 % .
-METHODS	Data were recorded continuously and complications were recorded during hospital stay with a maximum of 28 days .
-RESULTS	The number of complications was not significantly different between groups ( 11 vs 20 ; p = 0.23 ) .
-RESULTS	Eleven patients in the intervention group had no complication , versus 7 in the control group .
-RESULTS	There was no significant difference between groups in length of stay in ICU or in hospital .
-RESULTS	Only ten patients in the intervention group received dobutamine .
-RESULTS	Administration of dobutamine resulted in a moderate 6 [ -3 to 10 ] % increase of StO2 .
-RESULTS	The overall protocol adherence was 94 % .
-CONCLUSIONS	No statistically significant difference in outcome was realized through intraoperative optimization of StO2 values in this pilot study .
-CONCLUSIONS	The protocol used may be considered feasible for clinical practice .
-CONCLUSIONS	Further research is obligatory to define both the optimal StO2 threshold and intervention to treat tissue hypoperfusion .
-BACKGROUND	ClinicalTrials.gov identifier : NCT01342900 .
-BACKGROUND	Registered 21 April 2011 .
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-###25421015
-OBJECTIVE	To compare the pharmacodynamic effects of the highest approved doses of the sodium glucose co-transporter 2 ( SGLT2 ) inhibitors canagliflozin and dapagliflozin on urinary glucose excretion ( UGE ) , renal threshold for glucose excretion ( RTG ) and postprandial plasma glucose ( PPG ) excursion in healthy participants in a randomized , double-blind , two-period crossover study .
-METHODS	In each treatment period , participants ( n = 54 ) received canagliflozin 300mg or dapagliflozin 10mg for 4days ( 20min before breakfast ) .
-METHODS	A mixed-meal tolerance test ( 600kcal ; 75g glucose ) was performed at baseline and on day 4 of each treatment period to assess changes in incremental PPG ( PPGAUC0-2 h ) .
-METHODS	We measured 24-h UGE and plasma glucose on day 4 to determine 24-h mean RTG .
-RESULTS	Canagliflozin 300mg and dapagliflozin 10mg had similar effects on UGE and RTG for 4h after dosing , but canagliflozin was associated with higher UGE and greater RTG reductions for the remainder of the day .
-RESULTS	Mean 24-h UGE was 25 % higher with canagliflozin than with dapagliflozin ( 51.4 vs. 40.8 g ) , and 24-h mean RTG was 0.4 mmol/l ( 7 mg/dl ) lower with canagliflozin than with dapagliflozin ( 3.79 vs. 4.17 mmol/l ; p < 0.0001 ) .
-RESULTS	Dapagliflozin had no effect on PPG excursion ; canagliflozin delayed and reduced PPG excursion ( between-treatment difference in PPGAUC0-2 h from baseline expressed as a percentage of baseline mean , -10.2 % ; p = 0.0122 ) .
-RESULTS	Canagliflozin and dapagliflozin were generally well tolerated .
-CONCLUSIONS	In healthy participants , canagliflozin 300mg provided greater 24-h UGE , a lower RTG and smaller PPG excursions than dapagliflozin 10mg .
-
-###25933031
-BACKGROUND	In postmenopausal osteoporotic women , denosumab fully inhibits teriparatide-induced bone resorption at approved doses .
-BACKGROUND	This property of denosumab is distinct from that of alendronate and likely contributes to the efficacy of combination denosumab and teriparatide therapy .
-BACKGROUND	Whether denosumab fully inhibits bone resorption when challenged by a higher dose of teriparatide is unknown .
-OBJECTIVE	We aimed to define the comparative ability of denosumab and alendronate to block the acute proresorptive effects of high-dose teriparatide .
-METHODS	In this randomized controlled trial , bone resorption ( serum C-telopeptide [ CTX ] ) was measured in 25 postmenopausal women prior to and 4 hours after a single 40-g sc teriparatide injection .
-METHODS	Subjects then received either a single injection of denosumab 60 mg or oral alendronate 70 mg weekly for 8 weeks .
-METHODS	After 8 weeks , serum CTX was again measured before and 4 hours after a teriparatide a 40-g injection .
-RESULTS	The primary outcome was the between-group difference in the teriparatide-induced change in CTX from baseline to week 8 .
-RESULTS	At baseline , 40 g of teriparatide induced similar 4-hour increases in mean CTX in both groups ( alendronate 47 % 14 % , denosumab 46 % 16 % ) .
-RESULTS	After 8 weeks , teriparatide was still able to stimulate bone resorption in women treated with alendronate ( mean CTX increase of 43 % 29 % ) but not in women treated with denosumab ( -7 % 11 % ; P < .001 for between group comparison ) .
-CONCLUSIONS	Denosumab , but not alendronate , fully inhibits the ability of high-dose teriparatide to increase bone resorption acutely .
-CONCLUSIONS	These results suggest that combining denosumab with a more potent anabolic stimulus may result in greater separation between bone resorption and formation and hence greater increases in bone mass .
-
-###25443864
-BACKGROUND	This paper reports a cluster analysis of a sample recruited from a randomized controlled trial that explored the effect of using a life story work approach to improve the psychological outcomes of older people in the community .
-METHODS	238 subjects from community centers were included in this analysis .
-METHODS	After statistical testing , 169 seniors were assigned to the active ageing ( AG ) cluster and 69 to the inactive ageing ( IG ) cluster .
-RESULTS	Those in the AG were younger and healthier , with fewer chronic diseases and fewer depressive symptoms than those in the IG .
-RESULTS	They were more satisfied with their lives , and had higher self-esteem .
-RESULTS	They met with their family members more frequently , they engaged in more leisure activities and were more likely to have the ability to move freely .
-CONCLUSIONS	In summary , active ageing was observed in people with better health and functional performance .
-CONCLUSIONS	Our results echoed the limited findings reported in the literature .
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-###25840501
-BACKGROUND	Rehabilitation provided through home visits is part of the continuum of care after discharge from hospital following total knee arthroplasty ( TKA ) .
-BACKGROUND	As demands for rehabilitation at home are growing and becoming more difficult to meet , in-home telerehabilitation has been proposed as an alternate service delivery method .
-BACKGROUND	However , there is a need for robust data concerning both the effectiveness and the cost of dispensing in-home telerehabilitation .
-OBJECTIVE	The objective of this study was to document , analyze , and compare real costs of two service delivery methods : in-home telerehabilitation and conventional home visits .
-METHODS	The economic analysis was conducted as part of a multicenter randomized controlled trial ( RCT ) on telerehabilitation for TKA , and involved data from 197 patients , post-TKA .
-METHODS	Twice a week for 8 weeks , participants received supervised physiotherapy via two delivery methods , depending on their study group allocation : in-home telerehabilitation ( TELE ) and home-visit rehabilitation ( VISIT ) .
-METHODS	Patients were recruited from eight hospitals in the province of Quebec , Canada .
-METHODS	The TELE group intervention was delivered by videoconferencing over high-speed Internet .
-METHODS	The VISIT group received the same intervention at home .
-METHODS	Costs related to the delivery of the two services ( TELE and VISIT ) were calculated .
-METHODS	Student 's t tests were used to compare costs per treatment between the two groups .
-METHODS	To take distance into account , the two treatment groups were compared within distance strata using two-way analyses of variance ( ANOVAs ) .
-RESULTS	The mean cost of a single session was Can $ 93.08 for the VISIT group ( SD $ 35.70 ) and $ 80.99 for the TELE group ( SD $ 26.60 ) .
-RESULTS	When comparing both groups , real total cost analysis showed a cost differential in favor of the TELE group ( TELE minus VISIT : - $ 263 , 95 % CI - $ 382 to - $ 143 ) .
-RESULTS	However , when the patient 's home was located less than 30 km round-trip from the health care center , the difference in costs between TELE and VISIT treatments was not significant ( P = .25 , .26 , and .11 for the < 10 , 10-19 , and 20-29 km strata , respectively ) .
-RESULTS	The cost of TELE treatments was lower than VISIT treatments when the distance was 30 km or more ( 30-49 km : $ 81 < $ 103 , P = .002 ; 50 km : $ 90 < $ 152 , P < .001 ) .
-CONCLUSIONS	To our knowledge , this is the first study of the actual costs of in-home telerehabilitation covering all subcosts of telerehabilitation and distance between the health care center and the patient 's home .
-CONCLUSIONS	The cost for a single session of in-home telerehabilitation compared to conventional home-visit rehabilitation was lower or about the same , depending on the distance between the patient 's home and health care center .
-CONCLUSIONS	Under the controlled conditions of an RCT , a favorable cost differential was observed when the patient was more than 30 km from the provider .
-CONCLUSIONS	Stakeholders and program planners can use these data to guide decisions regarding introducing telerehabilitation as a new service in their clinic .
-BACKGROUND	International Standard Registered Clinical Study Number ( ISRCTN ) : 66285945 ; http://www.isrctn.com/ISRCTN66285945 ( Archived by WebCite at http://www.webcitation.org/6WlT2nuX4 ) .
-
-###24240354
-OBJECTIVE	This study aimed to determine the probability and risk factors for developing a corneal inflammatory event ( CIE ) during daily wear of lotrafilcon A silicone hydrogel contact lenses .
-METHODS	Eligible participants ( n = 218 ) were fit with lotrafilcon A lenses for daily wear and followed up for 12 months .
-METHODS	Participants were randomized to either a polyhexamethylene biguanide-preserved multipurpose solution or a one-step peroxide disinfection system .
-METHODS	The main exposures of interest were bacterial contamination of lenses , cases , lid margins , and ocular surface .
-METHODS	Kaplan-Meier ( KM ) plots were used to estimate the cumulative unadjusted probability of remaining free from a CIE , and multivariate Cox proportional hazards regression was used to model the hazard of experiencing a CIE.
-RESULTS	The KM unadjusted cumulative probability of remaining free from a CIE for both lens care groups combined was 92.3 % ( 95 % confidence interval [ CI ] , 88.1 to 96.5 % ) .
-RESULTS	There was one participant with microbial keratitis , five participants with asymptomatic infiltrates , and seven participants with contact lens peripheral ulcers , providing KM survival estimates of 92.8 % ( 95 % CI , 88.6 to 96.9 % ) and 98.1 % ( 95 % CI , 95.8 to 100.0 % ) for remaining free from noninfectious and symptomatic CIEs , respectively .
-RESULTS	The presence of substantial ( > 100 colony-forming units ) coagulase-negative staphylococci bioburden on lid margins was associated with about a five-fold increased risk for the development of a CIE ( p = 0.04 ) .
-CONCLUSIONS	The probability of experiencing a CIE during daily wear of lotrafilcon A contact lenses is low , and symptomatic CIEs are rare .
-CONCLUSIONS	Patient factors , such as high levels of bacterial bioburden on lid margins , contribute to the development of noninfectious CIEs during daily wear of silicone hydrogel lenses .
-
-###25503447
-BACKGROUND	Home-based exercise has been shown to provide benefits in terms of physical capacity in the general population , but has been scarcely investigated in patients with chronic kidney disease ( CKD ) .
-OBJECTIVE	To evaluate the impact of a home-based aerobic training on the cardiopulmonary and functional capacities of overweight non-dialysis-dependent patients with CKD ( NDD-CKD ) .
-METHODS	Twenty-nine sedentary patients ( 55.1 11.6 years , BMI = 31.2 6.1 kg/m ( 2 ) , eGFR = 26.9 17.4 mL/min/1 .73 m ( 2 ) ) were randomly assigned to a home-based exercise group ( n = 14 ) or to a control group ( n = 15 ) that remained without performing exercise .
-METHODS	Aerobic training was performed three times per week for 12 weeks .
-METHODS	A cardiopulmonary exercise test , functional capacity and clinical parameters were evaluated .
-RESULTS	A significant increase , ranging from 8.3 to 17 % , was observed in the cardiopulmonary capacity parameters , such as maximal ventilation ( p = 0.005 ) , VO2peak ( p = 0.049 ) , ventilatory threshold ( p = 0.040 ) and respiratory compensation point ( p < 0.001 ) , of the exercise group .
-RESULTS	A simultaneous improvement in the functional capacity tests [ 6-min walk test ( p < 0.001 ) , time up and go test ( p < 0.001 ) , arm curl test ( p < 0.001 ) , sit and stand test ( p < 0.001 ) , 2-min step test ( p < 0.001 ) and back scratch test ( p = 0.042 ) ] was also found in patients who were submitted to the exercise .
-RESULTS	Exercised patients experienced a decrease in systolic and diastolic blood pressure , average 10.6 % ( p < 0.001 ) and 9.2 % ( p = 0.007 ) , respectively , and a trend toward improved renal function ( p = 0.1 ) .
-RESULTS	No change in any parameter was found in the control group during the follow-up .
-CONCLUSIONS	The home-based aerobic exercise program was feasible , safe and effective for the improvement in the cardiopulmonary and functional capacities of overweight NDD-CKD patients .
-
-###25481454
-OBJECTIVE	To assess the effectiveness of the Healthy School and Drugs ( HSD ) program for secondary schools on the development of substance use among Dutch early adolescents and to explore whether boys , adolescents of lower educational backgrounds , or adolescents high on personality risk traits , would benefit more from the HSD program than others .
-METHODS	Randomized clustered trial with two intervention conditions ( i.e. , lessons and integral ) among a general population of adolescents in the Netherlands .
-METHODS	A total of 3784 students of 23 Dutch secondary schools .
-METHODS	Structured digital questionnaires were administered pre-intervention and at 8 , 20 , and 32months follow-ups .
-METHODS	The outcome measure was the rate of change in substance use across follow-ups .
-METHODS	Differential effectiveness of the HSD program was examined for sex , educational level , and personality traits .
-RESULTS	Our results show no HSD intervention effects on the development of substance use .
-RESULTS	Sex , education level , and personality characteristics of the participants did not moderate the intervention effects .
-CONCLUSIONS	The absence of effects of the Healthy School and Drugs program on the development of substance use indicates that the program should be renewed and redeveloped .
-
-###24853922
-METHODS	Cross-sectional diagnostic accuracy study .
-OBJECTIVE	To investigate the relationship between history and physical examination findings and the outcome of electrodiagnostic testing in patients with sciatica referred to physical therapy .
-BACKGROUND	Electrodiagnostic testing is routinely used to evaluate patients with sciatica .
-BACKGROUND	Recent evidence suggests that the presence of radiculopathy identified with electrodiagnostic testing may predict better functional outcomes in these patients .
-BACKGROUND	While some patient history and physical examination findings have been shown to predict the presence of disc herniation or neurological insult , little is known about their relationship to the results of electrodiagnostic testing .
-METHODS	Electrodiagnostic testing was performed on 38 patients with sciatica who participated in a randomized trial that compared different physical therapy interventions .
-METHODS	The diagnostic gold standard was the presence or absence of radiculopathy , based on the results of the needle electromyographic examination .
-METHODS	Diagnostic sensitivity and specificity values were calculated , along with corresponding likelihood ratios , for select patient history and physical examination variables .
-RESULTS	No significant relationship was found between select patient history and physical examination findings , analyzed individually or in combination , and the outcome of electrodiagnostic testing .
-RESULTS	Diagnostic sensitivity values ranged from 0.03 ( 95 % confidence interval [ CI ] : 0.00 , 0.24 ) to a high of 0.95 ( 95 % CI : 0.72 , 0.99 ) , and specificity values ranged from 0.10 ( 95 % CI : 0.02 , 0.34 ) to a high of 0.95 ( 95 % CI : 0.72 , 0.99 ) .
-RESULTS	Positive likelihood ratios ranged from 0.15 ( 95 % CI : 0.01 , 2.87 ) to a high of 2.33 ( 95 % CI : 0.71 , 7.70 ) , and negative likelihood ratios ranged from 2.00 ( 95 % CI : 0.35 , 11.48 ) to a low of 0.50 ( 95 % CI : 0.03 , 8.10 ) .
-CONCLUSIONS	In this investigation , the relationship between patient history and physical examination findings and the outcome of electrodiagnostic testing among patients with sciatica was not found to be statistically significant or clinically meaningful .
-CONCLUSIONS	However , given the small sample size and corresponding large CIs , these results should be considered with caution , recognizing that some of the history and physical examination variables may prove useful in future research .
-CONCLUSIONS	These findings suggest that electrodiagnostic testing is essential to identify the subgroup of patients with sciatica who have measurable nerve injury consistent with radiculopathy , which may be an important prognostic factor for recovery .
-CONCLUSIONS	Level of Evidence Diagnosis , level 3b - .
-CONCLUSIONS	J Orthop Sports Phys Ther 2014 ; 44 ( 7 ) :508 -517 .
-CONCLUSIONS	Epub 22 May 2014 .
-CONCLUSIONS	doi :10.2519 / jospt .2014.5002 .
-
-###25927536
-BACKGROUND	This analysis is based on a survey questionnaire designed to describe medical educators ' views of psychiatry and psychiatrists .
-BACKGROUND	Our goals in this paper were to assess the psychometric properties of the survey questions by ( a ) using exploratory factor analysis to identify the basic factor structure underlying 37 survey items ; ( b ) testing the resulting factor structure using confirmatory factor analysis ; and ( c ) assessing the internal reliability of each identified factor .
-BACKGROUND	To our knowledge , this is the first attempt to use these techniques to psychometrically assess a scale measuring the strength of stigma that medical educators attached to psychiatry .
-METHODS	Survey data were collected from a random sample of 1,059 teaching faculty in 23 academic teaching sites in 15 countries .
-METHODS	We conducted exploratory and confirmatory factor analysis to identify the scale structure and Cronbach 's alpha to assess internal consistency of the resulting scales .
-RESULTS	Results showed that a two-factor solution was the best fit for the data .
-RESULTS	Following exploratory factor analysis , we conducted confirmatory factor analysis on a split half of the sample .
-RESULTS	Results highlighted several items with low loadings .
-RESULTS	Excluding factors with low correlations and allowing for several correlated variances resulted in a good fitting model explaining 95 % of the variance in the data .
-CONCLUSIONS	We identified two unidimensional scales .
-CONCLUSIONS	The Images Scale contained 11 items measuring stereotypic content concerning psychiatry and psychiatrists .
-CONCLUSIONS	The Efficacy of Psychiatry Scale contained 5 items addressing perceptions of the challenges and effectiveness of psychiatry as a discipline .
-
-###25925875
-OBJECTIVE	To evaluate the efficacy of Ginkgo biloba as a complementary therapy for attention-deficit/hyperactivity disorder ( ADHD ) .
-METHODS	Children and adolescents with ADHD received methylphenidate ( 20-30 mg/day ) plus either G. biloba ( 80-120 mg/day ) or placebo for 6 weeks .
-METHODS	Parent and teacher forms of the ADHD Rating Scale-IV ( ADHD-RS-IV ) were completed at baseline , week 2 , and week 6 .
-METHODS	Treatment response was defined as 27 % improvement from baseline in the ADHD-RS-IV .
-RESULTS	Compared with placebo , more reduction was observed with G. biloba regarding ADHD-RS-IV parent rating inattention score ( -7.74 1.94 vs. -5.34 1.85 , P < 0.001 ) and total score ( -13.1 3.36 vs. -10.2 3.01 , P = 0.001 ) as well as teacher rating inattention score ( -7.29 1.90 vs. -5.96 1.52 , P = 0.004 ) .
-RESULTS	Response rate was higher with G. biloba compared with placebo based on parent rating ( 93.5 % vs. 58.6 % , P = 0.002 ) .
-CONCLUSIONS	The G. biloba is an effective complementary treatment for ADHD .
-CONCLUSIONS	Further studies with longer treatment duration are warranted in this regard .
-CONCLUSIONS	IRCT2014111519958N1 .
-
-###24424629
-OBJECTIVE	To evaluate the long-term efficacy of pain reduction by two dose fractionation schedules used for low-dose radiotherapy of painful elbow syndrome .
-METHODS	Between February 2006 and February 2010 , 199evaluable patients were recruited for this prospective trial .
-METHODS	All patients received low-dose orthovoltage radiotherapy .
-METHODS	One course consisted of 6fractions in 3weeks .
-METHODS	In the case of insufficient pain remission after 6weeks , a second course was administered .
-METHODS	Patients were randomly assigned to one of two groups to receive single doses of either 0.5 or 1.0 Gy .
-METHODS	Endpoint was pain reduction .
-METHODS	Pain was measured before radiotherapy , as well as immediately after ( early response ) , 6weeks after ( delayed response ) and approximately 3years after ( long-term response ) completion of radiotherapy using a questionnaire-based visual analogue scale ( VAS ) and a comprehensive pain score ( CPS ) .
-RESULTS	Median follow-up was 35months ( range 9-57months ) .
-RESULTS	The overall early , delayed and long-term response rates for all patients were 80 , 90and 94 % , respectively .
-RESULTS	The mean VAS scores before treatment and those for early , delayed and long-term response in the 0.5 - and 1.0-Gy groups were 59.620.2 and 55.718.0 ( p = 0.46 ) ; 32.124.5 and 34.422.5 ( p = 0.26 ) ; 27.027.7 and 23.521.6 ( p = 0.82 ) and 10.715.0 and 21.526.9 ( p = 0.12 ) , respectively .
-RESULTS	The mean CPS values before treatment and those for early , delayed and long-term response were 8.72.9 and 8.13.1 ( p = 0.21 ) ; 4.53.2 and 5.03.4 ( p = 0.51 ) ; 3.93.6 and 2.82.8 ( p = 0.19 ) and 1.52.3 and 2.43.5 ( p = 0.27 ) , respectively .
-RESULTS	No significant differences in the quality of the long-term response were found between the 0.5 - and 1.0-Gy arms ( p = 0.28 ) .
-CONCLUSIONS	Low-dose radiotherapy is an effective treatment for the management of benign painful elbow syndrome .
-CONCLUSIONS	For radiation protection reasons , the dose for a radiotherapy series should not exceed 3.0 Gy .
-
-###25037854
-BACKGROUND	A recent clinical trial could not find differences between anti-inflammatory drugs , antibiotics and placebo in shortening the duration of symptoms in acute bronchitis .
-OBJECTIVE	To investigate if C-reactive protein ( CRP ) concentrations at presentation are predictive of symptom resolution in these patients .
-METHODS	We performed a secondary analysis of the data from a placebo-controlled , randomized clinical trial carried out in primary care .
-METHODS	Patients from 18 to 70 years of age presenting a respiratory tract infection of < 1 week of evolution , with cough as the predominant symptom and the presence of discoloured expectoration , were enrolled in the study .
-METHODS	On the baseline visit , CRP was determined in capillary blood and a five-item symptom diary was given .
-METHODS	Patients were followed up to 30 days .
-METHODS	The main outcome measure was the number of days with persistent cough .
-RESULTS	A total of 312 subjects fulfilled all the criteria for the efficacy analysis and had undergone the CRP test ; of these , 56.4 % presented a CRP value < 8 mg/l and 76 % presented < 20 mg/l .
-RESULTS	There were no significant differences in the median duration of cough : 10 days among patients with CRP concentrations < 8 mg/l [ 95 % confidence interval ( CI ) : 8-11 days ] , 11 days among those with concentrations ranging from 8 to 19 mg/l ( 95 % CI : 8-16 ) and 11 days in those with CRP > 20 mg/l ( 95 % CI : 9-12 ) ( P = 0.337 ) .
-CONCLUSIONS	Among patients with uncomplicated acute bronchitis and discoloured sputum , the CRP concentrations at presentation are not helpful for predicting symptom resolution .
-
-###24837298
-OBJECTIVE	Proxy measures are an alternative source of data for care home residents who are unable to complete the health utility measure , but the agreement levels between residents and care home staff for the EQ-5D have not been investigated previously .
-OBJECTIVE	The objective of the present study was to examine the inter-rater agreement levels for the reporting of EQ-5D by care home residents and staff , adjusting for the impact of clustering .
-METHODS	The data consist of EQ-5D scores for 565 pairs of care home residents and proxies and quality-adjusted life-years ( QALYs ) for 248 pairs .
-METHODS	Cluster-adjusted agreement was compared for the domains , index scores , and QALYs from the EQ-5D .
-METHODS	Factors influencing index score agreement are also described .
-RESULTS	The results show poor to fair agreement at the domain level ( cluster-adjusted Kappa -0.03 to 0.26 ) and moderate agreement at the score level ( cluster-adjusted intra-class correlation coefficient [ ICC ] 0.44-0 .50 ) and for QALYs ( cluster-adjusted ICC 0.59 ) .
-RESULTS	A higher likelihood of depression and lower cognitive impairment were both associated with smaller discrepancy between proxy and self-completed scores .
-CONCLUSIONS	Proxies appear to be an acceptable source of data for index scores and QALYs but may be less reliable if individual domains are considered .
-
-###25199526
-BACKGROUND	Knee osteoarthritis ( OA ) causes pain and long-term disability with annual healthcare costs exceeding $ 185 billion in the United States .
-BACKGROUND	Few medical remedies effectively influence the course of the disease .
-BACKGROUND	Finding effective treatments to maintain function and quality of life in patients with knee OA is one of the national priorities identified by the Institute of Medicine .
-BACKGROUND	We are currently conducting the first comparative effectiveness and cost-effectiveness randomized trial of Tai Chi versus a physical-therapy regimen in a sample of patients with symptomatic and radiographically confirmed knee OA .
-BACKGROUND	This article describes the design and conduct of this trial .
-METHODS	A single-center , 52-week , comparative effectiveness randomized controlled trial of Tai Chi versus a standardized physical-therapy regimen is being conducted at an urban tertiary medical center in Boston , Massachusetts .
-METHODS	The study population consists of adults40 years of age with symptomatic and radiographic knee OA ( American College of Rheumatology criteria ) .
-METHODS	Participants are randomly allocated to either 12 weeks of Tai Chi ( 2x/week ) or Physical Therapy ( 2x/week for 6 weeks , followed by 6 weeks of rigorously monitored home exercise ) .
-METHODS	The primary outcome measure is pain ( Western Ontario and McMaster Universities WOMAC ) subscale at 12 weeks .
-METHODS	Secondary outcomes include WOMAC stkiffness and function domain scores , lower extremity strength and power , functional balance , physical performance tests , psychological and psychosocial functioning , durability effects , health related quality of life , and healthcare utilization at 12 , 24 and 52 weeks .
-CONCLUSIONS	This study will be the first randomized comparative-effectiveness and cost-effectiveness trial of Tai Chi versus Physical Therapy in a large symptomatic knee OA population with long-term follow up .
-CONCLUSIONS	We present here a robust and well-designed randomized comparative-effectiveness trial that also explores multiple outcomes to elucidate the potential mechanisms of mind-body effect for a major disabling disease with substantial health burdens and economic costs .
-CONCLUSIONS	Results of this study are expected to have important public health implications for the large and growing population with knee OA .
-BACKGROUND	ClinicalTrials.gov identifier : NCT01258985 .
-
-###24649784
-BACKGROUND	General anesthesia ( GA ) is considered the gold standard for external dacryocystorhinostomy ( DCR ) surgery .
-BACKGROUND	There are few reports about laryngeal mask airway ( LMA ) use in DCR surgery .
-BACKGROUND	The aim of this study was to compare the use of endotracheal intubation ( ETT ) vs LMA for airway management during DCR surgery .
-METHODS	Ninety patients were randomized to two groups .
-METHODS	In the group C , ETT and in the group L , classic LMA was used to maintain and protect the airway during the procedure .
-METHODS	Hemodynamic data before , after intubation or LMA insertion and after skin incisions were recorded .
-METHODS	Coughing and straining at the end of anesthesia and postoperative nausea and vomiting ( PONV ) were recorded .
-RESULTS	In the group L , the mean arterial pressure and the heart rate after LMA insertion and after the skin incisions were significantly lower than the group C ( p < 0.05 ) .
-RESULTS	Furthermore , incidence of coughing , straining at the end of anesthesia and PONV was lower in the group L than the group C ( p < 0.05 ) .
-CONCLUSIONS	LMA can be used in external DCR , to decrease the hemodynamic changes , to decrease coughing , straining at the end of anesthesia and the incidence of PONV .
-
-###25996273
-OBJECTIVE	Optimization of glycemic control is critical to reduce the number of diabetes mellitus-related complications , but long-term success is challenging .
-OBJECTIVE	Although vision loss is among the greatest fears of individuals with diabetes , comprehensive personalized diabetes education and risk assessments are not consistently used in ophthalmologic settings .
-OBJECTIVE	To determine whether the point-of-care measurement of hemoglobin A ( 1c ) ( HbA ( 1c ) ) and personalized diabetes risk assessments performed during retinal ophthalmologic visits improve glycemic control as assessed by HbA ( 1c ) level .
-METHODS	Ophthalmologist office-based randomized , multicenter clinical trial in which investigators from 42 sites were randomly assigned to provide either a study-prescribed augmented diabetes assessment and education or the usual care .
-METHODS	Adults with type 1 or 2 diabetes enrolled into 2 cohorts : those with a more-frequent-than-annual follow-up ( 502 control participants and 488 intervention participants ) and those with an annual follow-up ( 368 control participants and 388 intervention participants ) .
-METHODS	Enrollment was from April 2011 through January 2013 .
-METHODS	Point-of-care measurements of HbA1c , blood pressure , and retinopathy severity ; an individualized estimate of the risk of retinopathy progression derived from the findings from ophthalmologic visits ; structured comparison and review of past and current clinical findings ; and structured education with immediate assessment and feedback regarding participant 's understanding .
-METHODS	These interventions were performed at enrollment and at routine ophthalmic follow-up visits scheduled at least 12 weeks apart .
-METHODS	Mean change in HbA ( 1c ) level from baseline to 1-year follow-up .
-METHODS	Secondary outcomes included body mass index , blood pressure , and responses to diabetes self-management practices and attitudes surveys .
-RESULTS	In the cohort with more-frequent-than-annual follow-ups , the mean ( SD ) change in HbA ( 1c ) level at 1 year was -0.1 % ( 1.5 % ) in the control group and -0.3 % ( 1.4 % ) in the intervention group ( adjusted mean difference , -0.09 % [ 95 % CI , -0.29 % to 0.12 % ] ; P = .35 ) .
-RESULTS	In the cohort with annual follow-ups , the mean ( SD ) change in HbA ( 1c ) level was 0.0 % ( 1.1 % ) in the control group and -0.1 % ( 1.6 % ) in the intervention group ( mean difference , -0.05 % [ 95 % CI , -0.27 % to 0.18 % ] ; P = .63 ) .
-RESULTS	Results were similar for all secondary outcomes .
-CONCLUSIONS	Long-term optimization of glycemic control is not achieved by a majority of individuals with diabetes .
-CONCLUSIONS	The addition of personalized education and risk assessment during retinal ophthalmologic visits did not result in a reduction in HbA ( 1c ) level compared with usual care over 1 year .
-CONCLUSIONS	These data suggest that optimizing glycemic control remains a substantive challenge requiring interventional paradigms other than those examined in our study .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01323348 .
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-###25227544
-OBJECTIVE	To determine whether manual wheelchair configuration impacts how well a person who has acquired brain injury ( ABI ) related hemiparesis performs functional tasks from his or her wheelchair .
-METHODS	Multi-treatment cross-over design .
-METHODS	Inpatient rehabilitation hospital .
-METHODS	Nineteen patients with ABI resulting in hemiparesis undergoing inpatient rehabilitation ( average of 75 days post-injury ( 29.2 days ) ; age range , 21-64 ; 9 with mechanical brain injury , 10 with cerebral vascular accident ) .
-METHODS	Participants in the study were placed in two different wheelchair configurations ( position one and position two ) and were randomized as to which position they were placed in first .
-METHODS	All outcome measures were taken twice on each individual within each wheelchair configuration during two consecutive days .
-METHODS	Timed Forward Wheeling ( TFW ) , Modified Functional Reach test ( MFR ) , Visual Analogue Scale for Comfort ( VAS ) , transfer score from the Functional Independence Measure ( FIM ) , measurement of popliteal fossa to front of cushion .
-RESULTS	The position two seating group 's TFW was significantly faster than the position one seating group at both time points .
-RESULTS	There were no significant differences in the MFR scores , VAS comfort scale scores , and FIM transfer score between the two groups .
-CONCLUSIONS	A wheelchair configuration with no seat slope , solid backrest mounted at 95 degree ( 3 degrees ) seat to back angle , and use of a solid seat insert with a flat foam cushion ( position two ) results in greater efficiency in foot propulsion for individuals with ABI than a wheelchair configuration with one inch of seat slope , solid backrest mounted at 105 degree ( 3 degrees ) seat to back angle , and no solid seat insert with a gel/foam contoured cushion ( position 1 ) .
-
-###24793409
-OBJECTIVE	In primary care the diagnosis of CHF and ECF accumulation is no triviality .
-OBJECTIVE	We aimed to predict plasma BNP , CHF and ECF accumulation with segmental impedance spectroscopy while using and extending the electrodes of the conventional electrocardiography .
-METHODS	Three combined multiple electrodes were added to the 15 lead ECG for segmental impedance spectroscopy and for measuring the maximal rate of segmental fluid volume change with heart action at the thorax and the legs .
-METHODS	The obtained signals were analyzed by partial correlation analyses in comparison with plasma BNP , CHF classes , ejection fraction by echocardiography and cardiac index by double gas re-breathing .
-METHODS	119 subjects ( 34 healthy volunteers , 50 patients with CHF , NYHA classes II to IV and 35 patients without CHF ) were investigated .
-RESULTS	The maximal rate of volume change with heart action at the thorax and at the legs , as well as the ECF/ICF ratio at the legs contribute equally and independently to the prediction of BNP and heart failure in an unknown test sample of 49 patients ( multiple r = 0.88 , p < 0.001 ) .
-RESULTS	The ROC-curve for the predicted plasma BNP > 400 pg/ml gave an AUC = 0.93 .
-RESULTS	The absence or the presence of heart failure could be predicted correctly by a binomial logistic regression in 92.9 and 87.5 % of cases , respectively .
-CONCLUSIONS	The methodology , which is based on inverse coupling of BNP release and of maximal blood acceleration and on sensitive detection of ECF overload , could enable the diagnosis of CHF with useful sensitivity and specificity while writing a routine-ECG .
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-###25081673
-BACKGROUND	Although continuing education is necessary for practicing nurses , it is very difficult to organize traditional classes because of large numbers of nurses and working shifts .
-BACKGROUND	Considering the increasing development of mobile electronic learning , we carried out a study to compare effects of the traditional face to face method with mobile learning delivered as text messages by cell phone .
-METHODS	Sixty female nurses working in our hospital were randomly divided into class and short message service ( SMS ) groups .
-METHODS	Lessons concerning breast cancer screening were prepared as 54 messages and sent in 17 days for the SMS group , while the class group participated in a class held by a university lecturer of breast and cancer surgery .
-METHODS	Pre - and post-tests were undertaken for both groups at the same time ; a retention test also was performed one month later .
-METHODS	For statistical analysis , the paired T test and the independent sample T test were used with SPSS software version 16 ; p < 0.05 was considered significant .
-RESULTS	Mean age and mean work experience of participants in class and SMS groups was 35.87.2 , 9.86.7 , 35.47.3 , and 11.58.5 , respectively .
-RESULTS	There was a significant increase in mean score post-tests ( compared with pre-tests ) in both groups ( p < 0.05 ) .
-RESULTS	Although a better improvement in scores of retention tests was demonstrated in the SMS group , the mean subtraction value of the post - and pretests as well as retention - and pre-tests showed no significant difference between the 2 groups ( p = 0.3 and p = 0.2 , respectively ) .
-CONCLUSIONS	Our study shows that teaching via SMS may probably replace traditional face to face teaching for continuing education in working nurses .
-CONCLUSIONS	Larger studies are suggested to confirm this .
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-###25751673
-OBJECTIVE	Use of hypotonic intravenous fluids for maintenance requirements is associated with increased risk of hyponatremia that results in morbidity and mortality in children .
-OBJECTIVE	Clinical trial data comparing isotonic and hypotonic maintenance fluids in nonsurgical hospitalized pediatric patients outside intensive care units are lacking .
-OBJECTIVE	To compare isotonic ( sodium chloride , 0.9 % , and dextrose , 5 % ) with hypotonic ( sodium chloride , 0.45 % , and dextrose , 5 % ) intravenous maintenance fluids in a hospitalized general pediatric population .
-METHODS	In this double-blind randomized clinical trial , we recruited 110 children admitted to a general pediatric unit of a tertiary care children 's hospital from March 1 , 2008 , through August 31 , 2012 ( age range , 1 month to 18 years ) , with normal baseline serum sodium levels who were anticipated to require intravenous maintenance fluids for 48 hours or longer ( intent-to-treat analyses ) .
-METHODS	Children with diagnoses that required specific fluid tonicity and volumes were excluded .
-METHODS	Patients were randomized to receive isotonic or hypotonic intravenous fluid at maintenance rates for 48 hours .
-METHODS	The primary outcome was mean serum sodium level at 48 hours .
-METHODS	The secondary outcomes were mean sodium level at 24 hours , hyponatremia and hypernatremia , weight gain , hypertension , and edema .
-METHODS	Confounding variables were included in multiple regression models .
-METHODS	Post hoc analyses included change from baseline sodium level at 24 and 48 hours and subgroup analysis of children with primary respiratory diagnosis .
-RESULTS	Of 110 enrolled patients , 54 received isotonic fluids and 56 received hypotonic fluids .
-RESULTS	The mean ( SD ) sodium level at 48 hours was 139.9 ( 2.7 ) mEq/L in the isotonic group and 139.6 ( 2.6 ) mEq/L in the hypotonic group ( 95 % CI of the difference , -0.94 to 1.74 mEq/L ; P = .60 ) .
-RESULTS	Two patients in the hypotonic group developed hyponatremia , 1 in each group developed hypernatremia , 2 in each group developed hypertension , and 2 in the isotonic group developed edema .
-RESULTS	Mean ( SD ) change from baseline to 48-hour sodium level was +1.3 ( 2.9 ) vs -0.12 ( 2.8 ) mEq/L , respectively ( absolute difference , 1.4 mEq/L ; 95 % CI of the difference , -0.01 to 2.8 mEq/L ; P = .05 ) .
-CONCLUSIONS	Our study results support the notion that isotonic maintenance fluid administration is safe in general pediatric patients and may result in fewer cases of hyponatremia .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00632775 .
-
-###24842558
-BACKGROUND	Individuals with heterozygous familial hypercholesterolemia ( heFH ) have higher levels of low-density lipoprotein cholesterol ( LDL-C ) and are predisposed to premature cardiovascular disease .
-BACKGROUND	Alirocumab is a fully-human , monoclonal antibody targeted to proprotein convertase subtilisin/kexin type 9 currently in Phase 3 development for the treatment of hypercholesterolemia .
-BACKGROUND	Described here are three ODYSSEY Phase 3 trials , FH I ( NCT01623115 ) , FH II ( NCT01709500 ) and HIGH FH ( patients with heFH and LDL-C levels 160mg/dL ) ( NCT01617655 ) , in which alirocumab is further evaluated in the heFH population .
-METHODS	Multicenter , multinational , randomized , double-blind , placebo-controlled studies have been designed to evaluate efficacy and safety of alirocumab in more than 800 patients with heFH who are not adequately controlled with a maximally-tolerated stable daily dose of statin for 4weeks prior to the screening visit , with or without other lipid-lowering therapy .
-METHODS	Patients are randomized ( 2:1 ) to receive alirocumab or placebo via a 1-mL subcutaneous auto-injection every 2weeks ( Q2W ) for 78weeks .
-METHODS	In studies FH I and II , if their Week 8 LDL-C level is 70mg/dL , patients will undergo a dose uptitration from 75 to 150mg alirocumab Q2W at Week 12 .
-METHODS	In HIGH FH , patients will receive alirocumab 150mg Q2W throughout the entire treatment period .
-METHODS	The primary efficacy endpoint in all three studies is the percent change in calculated LDL-C from baseline to Week 24 .
-CONCLUSIONS	The ODYSSEY FH studies are three Phase 3 studies aiming to further evaluate the efficacy and long-term safety of alirocumab as an effective therapeutic option for patients with heFH .
-
-###24988955
-OBJECTIVE	To study the efficacy of the domestic recombinant interleukin-2 ( IL-2 ) in the complex treatment of encephalitis .
-METHODS	Forty patients , aged from 6 months to 17 years , were treated with the drug .
-METHODS	A comparison group involved 35 patients who did not receive the drug .
-RESULTS	Recombinant IL-2 reduced ( p < 0.05 ) the aggravation of symptoms to 5.41.3 days , neurological deficit ( 1.60.2 EDSS scores at discharge from the hospital ) , frequency of exacerbations ( from 22.9 to 5 % ) and frequency of cases with the development of multiple sclerosis during 3 years ( from 17.1 to 2.5 % ) .
-RESULTS	Parameters of the drug efficacy were correlated with positive changes in immunological parameters after 3-4 days of treatment .
-RESULTS	The study of multimodal evoked potentials demonstrated the positive effect of the drug on the central afferent conduction times .
-RESULTS	The follow-up MRI examination showed the decrease in the frequency of focal changes .
-CONCLUSIONS	Recombinant IL-2 is recommended for treatment of children with encephalitis .
-
-###24720558
-BACKGROUND	Patients with obstructive sleep apnea ( OSA ) experience respiratory events with greater frequency and severity while in the supine sleeping position .
-BACKGROUND	Postural modification devices ( PMDs ) prevent supine sleep , although there is a paucity of guidance to help clinicians decide when to use PMDs for their patients .
-BACKGROUND	In order for PMDs to treat OSA effectively , patients must experience respiratory events in the supine sleeping position consistently from night to night and must have a low nonsupine apnea and hypopnea index ( AHINS ) .
-OBJECTIVE	To document the repeatability of traditionally defined supine predominant OSA on consecutive polysomnography , to determine whether the consistency of the supine-predominant phenotype can be improved by altering the definition of it , and to determine whether a low AHINS is repeatable from night to night .
-METHODS	We recruited 75 patients for polysomnography on two separate nights .
-METHODS	Patients were classified as having supine OSA on each night on the basis of traditional and novel definitions , and the classification systems used were compared on the basis of agreement from night to night .
-RESULTS	The definition of supine OSA with the highest level of agreement from night to night incorporates a supine AHI ( AHIS ) to AHINS ratio 4:1 .
-RESULTS	In addition , agreement exists for males , but there is poor agreement for female patients , regardless of the definition applied .
-RESULTS	An AHINS < 10 events/hour is highly repeatable from night to night .
-CONCLUSIONS	Males with an AHIS : AHINS ratio 4:1 and an AHINS < 10 events/hour represent a consistent supine-predominant OSA phenotype from night to night .
-CONCLUSIONS	This patient group is likely to benefit from treatment with PMD .
-
-###25175097
-BACKGROUND	The management of depression in patients with poor prognosis cancers , such as lung cancer , creates specific challenges .
-BACKGROUND	We aimed to assess the efficacy of an integrated treatment programme for major depression in patients with lung cancer compared with usual care .
-METHODS	Symptom Management Research Trials ( SMaRT ) Oncology-3 is a parallel-group , multicentre , randomised controlled trial .
-METHODS	We enrolled patients with lung cancer and major depression from three cancer centres and their associated clinics in Scotland , UK .
-METHODS	Participants were randomly assigned in a 1:1 ratio to the depression care for people with lung cancer treatment programme or usual care by a database software algorithm that used stratification ( by trial centre ) and minimisation ( by age , sex , and cancer type ) with allocation concealment .
-METHODS	Depression care for people with lung cancer is a manualised , multicomponent collaborative care treatment that is systematically delivered by a team of cancer nurses and psychiatrists in collaboration with primary care physicians .
-METHODS	Usual care is provided by primary care physicians .
-METHODS	The primary outcome was depression severity ( on the Symptom Checklist Depression Scale [ SCL-20 ] , range 0-4 ) averaged over the patient 's time in the trial ( up to a maximum of 32 weeks ) .
-METHODS	Trial statisticians and data collection staff were masked to treatment allocation , but patients and clinicians could not be masked to the allocations .
-METHODS	Analyses were by intention to treat .
-METHODS	This trial is registered with Current Controlled Trials , number ISRCTN75905964 .
-RESULTS	142 participants were recruited between Jan 5 , 2009 , and Sept 9 , 2011 ; 68 were randomly allocated to depression care for people with lung cancer and 74 to usual care .
-RESULTS	43 ( 30 % ) of 142 patients had died by 32 weeks , all of which were cancer-related deaths .
-RESULTS	No intervention-related serious adverse events occurred .
-RESULTS	131 ( 92 % ) of 142 patients provided outcome data ( 59 in the depression care for people with lung cancer group and 72 in the usual care group ) and were included in the intention-to-treat primary analysis .
-RESULTS	Average depression severity was significantly lower in patients allocated to depression care for people with lung cancer ( mean score on the SCL-20 124 [ SD 064 ] ) than in those allocated to usual care ( mean score 161 [ SD 058 ] ) ; difference -038 ( 95 % CI -058 to -018 ) ; standardised mean difference -062 ( 95 % CI -094 to -029 ) .
-RESULTS	Self-rated depression improvement , anxiety , quality of life , role functioning , perceived quality of care , and proportion of patients achieving a 12-week treatment response were also significantly better in the depression care for people with lung cancer group than in the usual care group .
-CONCLUSIONS	Our findings suggest that major depression can be treated effectively in patients with a poor prognosis cancer ; integrated depression care for people with lung cancer was substantially more efficacious than was usual care .
-CONCLUSIONS	Larger trials are now needed to estimate the effectiveness and cost-effectiveness of this care programme in this patient population , and further adaptation of the treatment will be necessary to address the unmet needs of patients with major depression and even shorter life expectancy .
-BACKGROUND	Cancer Research UK and Chief Scientist Office of the Scottish Government .
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-###24986094
-OBJECTIVE	Glycopyrronium ( NVA237 ) , a once-daily long-acting muscarinic antagonist , has recently been approved for the treatment of patients with chronic obstructive pulmonary disease ( COPD ) .
-OBJECTIVE	This study evaluated the effect of glycopyrronium on the QT interval and other cardiac parameters in healthy subjects .
-METHODS	This randomized , partially blinded , single-dose , placebo - and positive - ( moxifloxacin ) controlled , three-way cross-over study investigated the effect of a single inhaled supra-therapeutic dose ( 8-fold clinical dose in COPD patients ) of 400 g glycopyrronium on the Fridericia-corrected QT interval ( QTcF ; primary objective ) , Bazettcorrected QT interval ( QTcB ) , heart rate , blood pressure , pharmacokinetics ( PK ) , safety , and tolerability .
-RESULTS	A total of 73 healthy male ( n = 35 ) and female ( n = 38 ) subjects , aged between 18 and 45 years , were randomized .
-RESULTS	Glycopyrronium did not cause significant QTcF prolongation compared to placebo .
-RESULTS	The largest time-matched mean difference to placebo was 2.97 ms at 5 minutes , with the upper limit of the two-sided 90 % confidence interval ( CI ) being 4.80 ms , excluding a relevant QT effect as defined by the ICH E14 guideline .
-RESULTS	Glycopyrronium had a slight bradycardic effect with a mean change of -2.88 ( 90 % CI : -3.78 , -1.99 ) beats per minutes ( bpm ) and a maximum of -5.87 ( 90 % CI : -7.82 , -3.92 ) bpm at 5 hours post-inhalation .
-RESULTS	No clinically relevant effects were seen on QTcB , other electrocardiogram ( ECG ) intervals , or blood pressure .
-RESULTS	Maximum plasma concentration ( Cmax ) of glycopyrronium was achieved shortly after inhalation ( median tmax = 7 minutes ) .
-RESULTS	All the treatments were well tolerated with no serious adverse events .
-CONCLUSIONS	A supra-therapeutic dose of glycopyrronium had a favorable cardiovascular safety profile with no clinically relevant effect on QT interval .
-
-###24388868
-BACKGROUND	If asthma patients fail to achieve symptom control using a medium dose of inhaled corticosteroid ( ICS ) alone , adding a long-acting 2 agonist ( LABA ) is the preferred treatment .
-BACKGROUND	We aimed to compare the effect of two widely available ICS/LABA combinations in these patients in real-life conditions : budesonide/formoterol ( BUD/FM ; Symbicort ( ) ) for maintenance and reliever therapy ( SMART ) and a fixed dose of fluticasone propionate/salmeterol ( FP/SM ) .
-METHODS	Inadequately controlled asthma patients treated with a medium dose of ICS alone , with an Asthma Control Questionnaire ( ACQ ) score > 0.75 and using a short-acting 2-agonist ( SABA ) 2-6 occasions/week , were enrolled .
-METHODS	Patients were randomized into two groups and treated with two inhalation twice-daily BUD/FM 160/4 .5 g plus as-needed BUD/FM ( SMART group , n = 15 ) or one inhalation twice-daily FP/SM 250/50g plus as-needed procaterol ( FP/SM group , n = 15 ) for 8 weeks .
-RESULTS	Both groups showed significant improvement in airway inflammation , pulmonary functions and symptoms from baseline .
-RESULTS	The SMART group showed significant improvement in the fraction of nitric oxide , ACQ score , rescue medication use and small airway parameter R5-R20 measured by impulse oscillometry compared with the FP/SM group .
-CONCLUSIONS	For stepping up treatment from ICS alone to an ICS/LABA combination , SMART is preferable for controlling asthma symptoms by suppressing airway inflammation and improving small airway impairment compared with a fixed dose of FP/SM .
-CONCLUSIONS	It may be achieved by the property of BUD/FM itself and as-needed use , but the degree of each contribution must be investigated further .
-
-###24268387
-OBJECTIVE	This study assessed the effects of systemic omega-3 on the treatment of recurrent aphthous stomatitis and on the improvement of quality of life .
-METHODS	Fifty participants were randomly assigned to receive either omega-3 ( 1 g , 3 times daily ) or placebo for 6 months .
-METHODS	Assessment of outcome measures including monthly number of new ulcers , average duration of ulcer episodes , and pain level of ulcers was carried out at baseline and monthly for 6 months .
-METHODS	Analysis of potential impact on quality of life using the Oral Health Impact Profile 14 was carried out at baseline and 6 months .
-RESULTS	Daily omega-3 treatment achieved a significant reduction in number of ulcers , duration of ulcers , and level of pain by 3 months that persisted for 6 months .
-RESULTS	Mean score on Oral Health Impact Profile 14 also significantly improved by 6 months .
-CONCLUSIONS	A daily omega-3 regimen shows promise as therapy for treatment and management of patients with recurrent aphthous stomatitis .
-
-###25361981
-BACKGROUND	We and others have recently shown that tumor characteristics are altered throughout tumor progression .
-BACKGROUND	These findings emphasize the need for re-examination of tumor characteristics at relapse and have led to recommendations from ESMO and the Swedish Breast Cancer group .
-BACKGROUND	Here , we aim to determine whether tumor characteristics and molecular subtypes in breast cancer metastases confer clinically relevant prognostic information for patients .
-METHODS	The translational aspect of the Swedish multicenter randomized trial called TEX included 111 patients with at least one biopsy from a morphologically confirmed locoregional or distant breast cancer metastasis diagnosed from December 2002 until June 2007 .
-METHODS	All patients had detailed clinical information , complete follow-up , and metastasis gene expression information ( Affymetrix array GPL10379 ) .
-METHODS	We assessed the previously published gene expression modules describing biological processes [ proliferation , apoptosis , human epidermal receptor 2 ( HER2 ) and estrogen ( ER ) signaling , tumor invasion , immune response , and angiogenesis ] and pathways ( Ras , MAPK , PTEN , AKT-MTOR , PI3KCA , IGF1 , Src , Myc , E2F3 , and - catenin ) and the intrinsic subtypes ( PAM50 ) .
-METHODS	Furthermore , by contrasting genes expressed in the metastases in relation to survival , we derived a poor metastasis survival signature .
-RESULTS	A significant reduction in post-relapse breast cancer-specific survival was associated with low-ER receptor signaling and apoptosis gene module scores , and high AKT-MTOR , Ras , and - catenin module scores .
-RESULTS	Similarly , intrinsic subtyping of the metastases provided statistically significant post-relapse survival information with the worst survival outcome in the basal-like [ hazard ratio ( HR ) 3.7 ; 95 % confidence interval ( CI ) 1.3-10 .9 ] and HER2-enriched ( HR 4.4 ; 95 % CI 1.5-12 .8 ) subtypes compared with the luminal A subtype .
-RESULTS	Overall , 25 % of the metastases were basal-like , 32 % HER2-enriched , 10 % luminal A , 28 % luminal B , and 5 % normal-like .
-CONCLUSIONS	We show that tumor characteristics and molecular subtypes of breast cancer metastases significantly influence post-relapse patient survival , emphasizing that molecular investigations at relapse provide prognostic and clinically relevant information .
-CONCLUSIONS	CLINICALTRIALS.GOV : This is the translational part of the Swedish multicenter and randomized trial TEX , clinicaltrials.gov identifier nct01433614 ( http://www.clinicaltrials.gov/ct2/show/nct01433614 ) .
-
-###25240548
-OBJECTIVE	This study aimed to determine whether remote ischemic conditioning ( RIC ) initiated prior to primary percutaneous coronary intervention ( PPCI ) could reduce myocardial infarct ( MI ) size in patients presenting with ST-segment elevation myocardial infarction .
-BACKGROUND	RIC , using transient limb ischemia and reperfusion , can protect the heart against acute ischemia-reperfusion injury .
-BACKGROUND	Whether RIC can reduce MI size , assessed by cardiac magnetic resonance ( CMR ) , is unknown .
-METHODS	We randomly assigned 197 ST-segment elevation myocardial infarction patients with TIMI ( Thrombolysis In Myocardial Infarction ) flow grade 0 to receive RIC ( four 5-min cycles of upper arm cuff inflation/deflation ) or control ( uninflated cuff placed on upper arm for 40 min ) protocols prior to PPCI .
-METHODS	The primary study endpoint was MI size , measured by CMR in 83 subjects on days 3 to 6 after admission .
-RESULTS	RIC reduced MI size by 27 % , when compared with the MI size of control subjects ( 18.0 10 % [ n = 40 ] vs. 24.5 12.0 % [ n = 43 ] ; p = 0.009 ) .
-RESULTS	At 24 h , high-sensitivity troponin T was lower with RIC ( 2,296 263 ng/l [ n = 89 ] vs. 2,736 325 ng/l [ n = 84 ] ; p = 0.037 ) .
-RESULTS	RIC also reduced the extent of myocardial edema measured by T2-mapping CMR ( 28.5 9.0 % vs. 35.1 10.0 % ; p = 0.003 ) and lowered mean T2 values ( 68.7 5.8 ms vs. 73.1 6.1 ms ; p = 0.001 ) , precluding the use of CMR edema imaging to correctly estimate the area at risk .
-RESULTS	Using CMR-independent coronary angiography jeopardy scores to estimate the area at risk , RIC , when compared with the control protocol , was found to significantly improve the myocardial salvage index ( 0.42 0.29 vs. 0.28 0.29 ; p = 0.03 ) .
-CONCLUSIONS	This randomized study demonstrated that in ST-segment elevation myocardial infarction patients treated by PPCI , RIC , initiated prior to PPCI , reduced MI size , increased myocardial salvage , and reduced myocardial edema .
-
-###25180869
-OBJECTIVE	To perform an analysis and comparative study of the clinical data for patients with cirrhosis and type 1 hepatorenal syndrome ( HRS ) who received treatment with terlipressin using high-or low-dose regimens .
-METHODS	A total of 56 patients with cirrhosis and type 1 HRS who presented for treatment to the Wuhan Medical Treatment Center and Taizhou Central Hospital between March 2010 and October 2012 were enrolled in the study .
-METHODS	The patients were randomly assigned to the terlipressin treatment groups for receipt of the high-dose regimen ( 1 mg/6 -8 h ; n = 27 ) or low-dose regimen ( 1 mg/12 h ; n = 29 ) .
-METHODS	All patients were assessed for 24-hour urine volume , serum blood urea nitrogen ( BUN ) and creatinine ( Cr ) levels , therapeutic effect and prognosis , and adverse reactions .
-METHODS	Measurements were made before and after the treatment , and on post-treatment days 3 , 7 and 14 .
-METHODS	Inter-group differences were assessed by statistical analyses .
-RESULTS	The high-dose group showed an increase in 24-hour urine volumes from post-treatment day 3 ( 1112 262 ml ) to day 7 ( 1938 312 ml ) , and the volumes on both days were significantly better than those of the low-dose group ( day 3:986 162 ml and day 7:1760 300 ml , t = 1.500 , 1.830 , P = 0.038 , 0.041 ) .
-RESULTS	The high-dose group also showed a significantly better decreases in serum BUN levels ( 35.1 8.6 to 30.2 6.3 mmol/L vs.low-dose group : 43.2 10.9 to 35.1 7.6 mmol/L , t = 3.200 , 5.901 , P = 0.043 , 0.047 ) and in serum Cr values ( 219.0 35.1 to 128.2 41.6 vs.low-dose group : 230.3 82.1 to 151.5 38.7 , t = 2.997 , 5.765 , P = 0.036 , 0.046 ) .
-RESULTS	On post-treatment day 14 the 24-hour urine volume of patients in the high-dose group decreased ( to 720 + / -136 ml ) , but the difference from that of the low-dose group was not significant ( vs. 620 164 ml , t = 1.855 , P = 0.069 ) .
-RESULTS	The serum BUN level increased in the high-dose group ( to 54.4 15.0 mmol/L ) , which was statistically different from that in the low-dose group ( vs .57.7 17.3 mmol/L , t = 5.166 , P = 0.022 ) ; the same trend was seen for the serum Cr value ( 397.8 127.4 mumol/L vs. 480.3 179.8 mumol/L , t = 5.638 , P = 0.047 ) .
-RESULTS	No statistically significant differences were observed for the groups in regard to significant efficiency , efficiency or 2-week survival rate ( x2 = 2.314 , 1.767 , 0.678 , P = 0.128 , 0.128 , 0.410 respectively ) , but the total efficiency was significantly different between the two groups ( x = 5.793 , P = 0.016 ) .
-RESULTS	In addition , no serious adverse reactions ( including precordial pain , myocardial infarction or intestinal necrosis ) were observed in either group .
-CONCLUSIONS	Terlipressin therapy at both high and low dosages can lead to significant beneficial effects within as little as 3 days after the treatment ; however , the high-dose appears to produce a better lasting efficacy ( at day 14 after the treatment ) .
-CONCLUSIONS	The difference in doses does not appear to markedly affect significant efficiency , efficiency , nor the 2-week survival rate .
-
-###25560448
-OBJECTIVE	To evaluate the effect of a clinic-based screening and referral system ( Well Child Care , Evaluation , Community Resources , Advocacy , Referral , Education [ WE CARE ] ) on families ' receipt of community-based resources for unmet basic needs .
-METHODS	We conducted a cluster randomized controlled trial at 8 urban community health centers , recruiting mothers of healthy infants .
-METHODS	In the 4 WE CARE clinics , mothers completed a self-report screening instrument that assessed needs for child care , education , employment , food security , household heat , and housing .
-METHODS	Providers made referrals for families ; staff provided requisite applications and telephoned referred mothers within 1 month .
-METHODS	Families at the 4 control community health centers received the usual care .
-METHODS	We analyzed the results with generalized mixed-effect models .
-RESULTS	Three hundred thirty-six mothers were enrolled in the study ( 168 per arm ) .
-RESULTS	The majority of families had household incomes < $ 20,000 ( 57 % ) , and 68 % had 2 unmet basic needs .
-RESULTS	More WE CARE mothers received 1 referral at the index visit ( 70 % vs 8 % ; adjusted odds ratio [ aOR ] = 29.6 ; 95 % confidence interval [ CI ] , 14.7-59 .6 ) .
-RESULTS	At the 12-month visit , more WE CARE mothers had enrolled in a new community resource ( 39 % vs 24 % ; aOR = 2.1 ; 95 % CI , 1.2-3 .7 ) .
-RESULTS	WE CARE mothers had greater odds of being employed ( aOR = 44.4 ; 95 % CI , 9.8-201 .4 ) .
-RESULTS	WE CARE children had greater odds of being in child care ( aOR = 6.3 ; 95 % CI , 1.5-26 .0 ) .
-RESULTS	WE CARE families had greater odds of receiving fuel assistance ( aOR = 11.9 ; 95 % CI , 1.7-82 .9 ) and lower odds of being in a homeless shelter ( aOR = 0.2 ; 95 % CI , 0.1-0 .9 ) .
-CONCLUSIONS	Systematically screening and referring for social determinants during well child care can lead to the receipt of more community resources for families .
-
-###24591266
-BACKGROUND	Inadequate surgical field visualization due to intraoperative bleeding during endoscopic sinus surgery ( ESS ) can cause major complications .
-BACKGROUND	The aim of this prospective study was to compare the effect of preoperative administration of clonidine and melatonin on the quality of the surgical field visualization and selected aspects of presurgical premedication .
-METHODS	Twenty-six patients undergoing ESS for chronic sinusitis and polyp removal were enrolled and randomly assigned to receive either oral clonidine or melatonin as preoperative premedication .
-METHODS	During the operation , the quality of the surgical field was assessed and graded using the scale proposed by Boezaart .
-METHODS	The evaluations were done at 15 , 30 , and 60 minutes after incision .
-METHODS	The effect of this premedication choice on the intraoperative and postoperative hemodynamic profile was examined in each group .
-METHODS	Anxiolytic effects of both premedication agents were assessed using the visual analogue scale for anxiety ( VAS-A ) .
-METHODS	Propofol dose and induction time ( the time for bispectral index [ BIS ] to reach 45 ) , anesthesia and surgical procedures time , and recovery time ( the time for BIS to reach 90 ) were assessed in both groups as well .
-RESULTS	The quality of the surgical field was consistently better in 2 of 3 time points in the clonidine group .
-RESULTS	Perioperative mean arterial pressure and intraoperative heart rate had a more favorable profile in patients premedicated with clonidine .
-RESULTS	There were no differences in other measured parameters between groups .
-CONCLUSIONS	Premedication with clonidine before ESS provides better quality of surgical field and more favorable hemodynamic profile as compared to melatonin .
-
-###24309022
-OBJECTIVE	To evaluate the effect of oral Lactobacillus reuteri ( L reuteri ) first on the incidence and severity of Necrotising enterocolitis ( NEC ) and second on sepsis .
-METHODS	Prospective randomised controlled study .
-METHODS	Tertiary neonatal intensive care unit .
-METHODS	Preterm infants with a gestational age of 32 weeks and a birth weight of 1500 g were included ( n = 400 ) .
-METHODS	Infants in the first group were given 100 million CFU/day ( 5 drops ) of lyophilised L reuteri ( DSM 17938 ) mixed in breast milk or formula , starting from first feeding until discharge .
-METHODS	Participants in the control group were given a placebo .
-METHODS	To determine and compare the frequency of NEC and/or death after 7 days , frequency of proven sepsis , rates of feeding intolerance and duration of hospital stay .
-RESULTS	There was no statistically significant difference between groups in terms of frequency of NEC stage 2 ( 4 % vs 5 % ; p = 0.63 ) or overall NEC or mortality rates ( 10 % vs 13.5 % ; p = 0.27 ) .
-RESULTS	Frequency of proven sepsis was significantly lower in the probiotic group compared to the control group ( 6.5 % vs 12.5 % ; p = 0.041 ) .
-RESULTS	A significant difference was also observed with regard to rates of feeding intolerance ( 28 % vs 39.5 % ; p = 0.015 ) and duration of hospital stay ( 38 ( 10-131 ) vs 46 ( 10-180 ) days ; p = 0.022 ) .
-CONCLUSIONS	Our results show that oral L reuteri does not seem to affect the overall rates of NEC and/or death in preterm infants followed up in the neonatal intensive care unit , and significant reductions were observed in the frequency of proven sepsis , rates of feeding intolerance and duration of hospital stay .
-BACKGROUND	NCT01531179 .
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-###25288513
-BACKGROUND	Current research suggests that glucose facilitates performance on cognitive tasks which possess an episodic memory component and a relatively high level of cognitive demand .
-BACKGROUND	However , the extent to which this glucose facilitation effect is uniform across the lifespan is uncertain .
-METHODS	This study was a repeated measures , randomised , placebo-controlled , cross-over trial designed to assess the cognitive effects of glucose in younger and older adults under single and dual task conditions .
-METHODS	Participants were 24 healthy younger ( average age 20.6 years ) and 24 healthy older adults ( average age 72.5 years ) .
-METHODS	They completed a recognition memory task after consuming drinks containing 25 g glucose and a placebo drink , both in the presence and absence of a secondary tracking task .
-CONCLUSIONS	Glucose enhanced recognition memory response time and tracking precision during the secondary task , in older adults only .
-CONCLUSIONS	These findings do not support preferential targeting of hippocampal function by glucose , rather they suggest that glucose administration differentially increases the availability of attentional resources in older individuals .
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-###25117033
-BACKGROUND	Hip and knee osteoarthritis are important causes of pain and disability among older people .
-BACKGROUND	Education and strength training can alleviate symptoms and avoid functional deterioration .
-OBJECTIVE	To assess muscle strength , fall risk and quality of life of older people with osteoarthritis and the effects of physiotherapy education and strength training on these variables .
-METHODS	Thirty participants aged 78 5 years ( 63 % women ) were randomly assigned to receive physiotherapy ( Controls ) , physiotherapy plus education ( Group 1 ) and physiotherapy plus strength training ( group 2 ) .
-METHODS	At baseline and after 16 weeks of intervention , patients were evaluated with the Senior Fitness Test , Timed Up and Go and Quality of Life score short form ( SF-36 ) .
-RESULTS	During the intervention period , Senior Fitness Test and Timed Up and Go scores improved in all groups and SF-36 did not change .
-RESULTS	The improvement in Senior Fitness Test and Timed Up and Go was more marked in Groups 1 and 2 than in the control group .
-CONCLUSIONS	Education and strength training improve functional tests among older people with osteoarthritis .
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-###25782685
-OBJECTIVE	Concurrent chemoradiotherapy ( CRT ) is the standard treatment for advanced head and neck squamous cell carcinoma .
-OBJECTIVE	In this phase II randomized study , the efficacy and toxicity of docetaxel , cisplatin and 5-fluorouracil induction chemotherapy ( ICT ) followed by concurrent CRT was compared with those after standard CRT alone in patients with locally advanced , unresectable head and neck cancer .
-METHODS	Between January 2007 and June 2009 , 66 patients with advanced ( stage III or IV ) unresectable squamous cell carcinoma of the head and neck ( oral cavity , oropharynx , hypopharynx , and larynx ) were randomly assigned to two groups : one receiving two cycles of docetaxel , cisplatin , and 5-fluorouracil ICT followed by CRT with three cycles of cisplatin and one treated by CRT alone .
-METHODS	Response rate , local tumor control ( LTC ) , locoregional tumor control ( LRTC ) , overall survival ( OS ) , progression-free survival ( PFS ) , and toxicity results were assessed .
-RESULTS	Three patients from the ICT + CRT group did not appear at the first treatment , so a total of 63 patients were evaluated in the study ( 30 ICT + CRT group and 33 CRT group ) .
-RESULTS	Three patients died of febrile neutropenia after ICT .
-RESULTS	The median follow-up time for surviving patients was 63 months ( range 53-82 months ) .
-RESULTS	The rate of radiologic complete response was 63 % following ICT + CRT , whereas 70 % after CRT alone .
-RESULTS	There were no significant differences in the 3-year rates of LTC ( 56 vs. 57 % ) , LRTC ( 42 vs. 50 % ) , OS ( 43 vs. 55 % ) , and PFS ( 41 vs. 50 % ) in the ICT + CRT group and in the CRT group , respectively .
-RESULTS	The rate of grade 3-4 neutropenia was significantly higher in the ICT + CRT group than in the CRT group ( 37 and 12 % ; p = 0.024 ) .
-RESULTS	Late toxicity ( grade 2 or 3 xerostomia ) developed in 59 and 42 % in the ICT + CRT and CRT groups , respectively .
-CONCLUSIONS	The addition of ICT to CRT did not show any advantage in our phase II trial , while the incidence of adverse events increased .
-CONCLUSIONS	The three deaths as a consequence of ICT call attention to the importance of adequate patient selection if ICT is considered .
-
-###24383406
-OBJECTIVE	To evaluate changes in self-reported nocturia in community-dwelling adults aged 60 and older who received behavioral treatment for chronic insomnia .
-METHODS	Secondary analysis of a randomized controlled trial of a behavioral intervention for sleep .
-METHODS	Academic medical center .
-METHODS	Of the 79 enrollees , this analysis focused on 30 who , in addition to insomnia , also reported at least one nightly episode of waking up to void .
-METHODS	The brief behavioral treatment of insomnia ( BBTI ) group ( n = 14 ) received instructions on reducing time in bed and setting a regular sleep schedule .
-METHODS	The information control ( IC ) group ( n = 16 ) received printed materials .
-METHODS	A nurse clinician delivered both interventions .
-METHODS	Self-reported nocturnal awakenings to void assessed daily for 14 days at baseline and 4 weeks after the intervention .
-METHODS	Participants who reported at least one episode of nocturia per night at baseline were included in this analysis .
-RESULTS	In individuals with nocturia at baseline , the total number of nocturnal voids over the 14-day assessment period decreased by 6.5 4.8 in the BBTI group and increased by 1.3 7.3 in the IC group ( P = .04 , effect size 0.82 ) .
-RESULTS	After adjusting for baseline nocturia episodes , the difference remained significant ( P = .05 ) .
-CONCLUSIONS	In older adults with concurrent insomnia and nocturia , behavioral treatment directed solely at insomnia may also improve self-reported nocturia .
-CONCLUSIONS	Behavioral treatment of insomnia should be further investigated for its effect on nocturia in individuals with concurrent insomnia and nocturia .
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-###25520340
-BACKGROUND	Attempts to improve proximal load transfer and minimize stress shielding have included reducing the stiffness of femoral stems and using alternative stem materials , including carbon fiber composites .
-BACKGROUND	An uncemented implant ( SR71 ) composed of a carbon-fiber-composite distal section and a porous-coated titanium-alloy proximal section , designed to improve proximal load transfer and provide good fixation , was clinically evaluated in a prospective randomized study .
-METHODS	Sixty patients were enrolled and randomized to receive either the SR71 stem or an all-metal stem ( Stability ) .
-METHODS	All patients received a cemented all-polyethylene acetabular component and a 28-mm metal femoral head .
-METHODS	All uncemented stems were implanted by the same surgeon .
-METHODS	Patients were followed for up to ten years with repeated assessments of bone mineral density , radiographs , Harris hip scores ( HHS ) , and visual analog scale ( VAS ) pain scores .
-RESULTS	Ten years postoperatively , nineteen patients who had been treated with the SR71 stem and not lost to follow-up showed a significantly greater increase in proximal bone mineral density ( Gruen zones 1 [ p = 0.003 ] and 7 [ p = 0.0007 ] ) from baseline than did the twenty-two who had been treated with the Stability stem and not lost to follow-up .
-RESULTS	In contrast , the Stability group showed a significantly greater increase in distal bone mineral density ( Gruen zones 2 [ p = 0.0004 ] , 3 [ p = 0.0001 ] , and 5 [ p = 0.0035 ] ) compared with the SR71 group .
-RESULTS	Radiographs demonstrated one case of progressive migration of an acetabular component used with an SR71 stem and one case of bone resorption in Gruen zones 7 and 14 in a patient treated with a Stability stem .
-RESULTS	There was no significant difference between the SR71 and Stability stems in terms of changes in the total HHS , HHS for pain , HHS for range of motion , or VAS pain scores ten years postoperatively relative to preoperative levels .
-RESULTS	There was one reported revision of an SR71 femoral stem at the ten-year review .
-CONCLUSIONS	The investigational SR71 implant provided increased proximal bone density and reduced distal bone density .
-CONCLUSIONS	The implant showed promising results at the time of early follow-up , and the clinical outcomes were similar to those of an all-metal stem at the time of a ten-year follow-up .
-
-###24252596
-BACKGROUND	Coronary artery disease ( CAD ) is accountable for more than 7 million deaths each year according to the World Health Organization ( WHO ) .
-BACKGROUND	In a European population 80 % of patients diagnosed with CAD are overweight and 31 % are obese .
-BACKGROUND	Physical inactivity and overweight are major risk factors in CAD , thus central strategies in secondary prevention are increased physical activity and weight loss .
-METHODS	In a randomized controlled trial 70 participants with stable CAD , age 45-75 , body mass index 28-40kg / m2 and no diabetes are randomized ( 1:1 ) to 12weeks of intensive exercise or weight loss both succeeded by a 40-week follow-up .
-METHODS	The exercise protocol consist of supervised aerobic interval training ( AIT ) at 85-90 % of VO2peak 3 times weekly for 12weeks followed by supervised AIT twice weekly for 40weeks .
-METHODS	In the weight loss arm dieticians instruct the participants in a low energy diet ( 800-1000kcal / day ) for 12weeks , followed by 40weeks of weight maintenance combined with supervised AIT twice weekly .
-METHODS	The primary endpoint of the study is change in coronary flow reserve after the first 12weeks ' intervention .
-METHODS	Secondary endpoints include cardiovascular , metabolic , inflammatory and anthropometric measures .
-CONCLUSIONS	The study will compare the short and long-term effects of a protocol consisting of AIT alone or a rapid weight loss followed by AIT .
-CONCLUSIONS	Additionally , it will provide new insight in mechanisms behind the benefits of exercise and weight loss .
-CONCLUSIONS	We wish to contribute to the creation of effective secondary prevention and sustainable rehabilitation strategies in the large population of overweight and obese patients diagnosed with CAD .
-BACKGROUND	ClinicalTrials.gov : NCT01724567 .
-
-###24392223
-BACKGROUND	The established interventions for weight loss are resource intensive which can create barriers for full participation and ultimate translation .
-BACKGROUND	The major goal of this pilot study was to evaluate the feasibility , acceptability , and preliminary efficacy of theoretically based behavioral interventions delivered by smartphone technology .
-METHODS	The study randomized 68 obese adults to receive one of four interventions for six months : ( 1 ) intensive counseling intervention , ( 2 ) intensive counseling plus smartphone intervention , ( 3 ) a less intensive counseling plus smartphone intervention , and ( 4 ) smartphone intervention only .
-METHODS	The outcome measures of weight , BMI , waist circumference , and self-reported dietary intake and physical activity were assessed at baseline and six months .
-RESULTS	The sample was 78 % female and 49 % African American , with an average age of 45 years , and average BMI of 34.3 kg/m ( 2 ) .
-RESULTS	There were trends for differences in weight loss among the four intervention groups .
-RESULTS	Participants in the intensive counseling plus self-monitoring smartphone group and less intensive counseling plus self-monitoring smartphone group tended to lose more weight than other groups ( 5.4 kg and 3.3 kg , resp . )
-CONCLUSIONS	The results of this pilot trial of a weight loss intervention provide preliminary support for using a smartphone application for self-monitoring as an adjunct to behavioral counseling .
-
-###24279519
-BACKGROUND	Atopic dermatitis is a chronic inflammatory skin disease with a high prevalence rate and a large socioeconomic cost .
-BACKGROUND	There are many treatments for atopic dermatitis , such as antihistamine , tacrolimus and corticosteroids .
-BACKGROUND	However , due to concern about the adverse effects , many patients seek alternative treatments .
-BACKGROUND	In this context , natural products are gaining interest .
-BACKGROUND	KM110329 is a functional food consisting of four herbs that are beneficial to skin health .
-BACKGROUND	The purpose of this study is to assess the efficacy and safety of KM110329 for atopic dermatitis .
-METHODS	This study is a randomised , double-blind , placebo-controlled and multicentre trial of KM110329 .
-METHODS	For this study , we will recruit 66 atopic dermatitis patients of both sexes , with ages ranging from 18 to 65 , from three university hospitals .
-METHODS	The participants will receive either KM110329 or a placebo twice a day for 8 weeks .
-METHODS	The primary end point will be a change in the scoring atopic dermatitis ( SCORAD ) index .
-METHODS	The secondary end points will include changes to the dermatology life quality index ( DLQI ) and transepidermal water loss ( TEWL ) , among others .
-METHODS	The outcomes will be measured at every visit .
-METHODS	The study will be continued for 8 weeks and will include five visits with each subject ( at screening and at 0 , 1 , 4 and 8 weeks ) .
-CONCLUSIONS	This trial will provide research methodologies for evaluate clinical efficacy and safety of KM110329 in adult patients with atopic dermatitis .
-CONCLUSIONS	In addition , we will evaluate the changes in the general skin health status and quality of life .
-BACKGROUND	ClinicalTrials.gov NCT01692093 .
-
-###24472401
-OBJECTIVE	The study is to investigate drug-drug interaction ( DDI ) between olmesartan medoxomil and hydrochlorothiazide ( HCTZ ) , to confirm bioequivalence ( BE ) of a new combined formulation and coadministration of separate local tablets , and to receive pharmacokinetics and tolerability of the new combined formulation after multiple doses in healthy Chinese subjects .
-METHODS	The 3-in-1 study was separated into 2 stages .
-METHODS	Stage 1 is a four-period crossover study .
-METHODS	28 healthy subjects were equally randomized into four groups .
-METHODS	Each group received the four following regimens in a sequence as Latin square ( 4 4 ) design : A : olmesartan medoxomil ; B : HCTZ ; C : test drug ( new combined formulation ) ; D : reference drugs ( co-administration of separate tablets ) .
-METHODS	In stage 2 , half of 28 subjects were daily dosed with regimen C for 7 days .
-METHODS	Blood and urine samples were obtained to receive pharmacokinetics of olmesartan and HCTZ , which were analyzed using the BE evaluation method .
-METHODS	Tolerability was also assessed .
-RESULTS	All subjects completed the study and nobody reported serious adverse event ( SAE ) .
-RESULTS	The 90 % confidence intervals ( CI ) of geometric mean ratio ( GMR ) of log transformed Cmax , AUC0-t , and AUC0 - after single dose showed no DDI and claimed BE .
-RESULTS	The mean ratio of accumulation ( Ra ) ( SD ) of olmesartan and HCTZ after multiple doses of new combination formulation is 1.03 ( 0.182 ) and 0.954 ( 0.128 ) .
-CONCLUSIONS	No significant DDI between olmesartan and HCTZ was found .
-CONCLUSIONS	The new combination formulation is bioequivalent to co-administration of two separate local tablets .
-CONCLUSIONS	After multiple doses of the new combination formulation , no significant accumulation was observed .
-CONCLUSIONS	The new combination formulation is reasonably tolerated well in healthy Chinese subjects after multiple doses .
-
-###25307535
-BACKGROUND	Achievement of target low-density lipoprotein ( LDL ) levels for secondary prevention is endorsed in Canadian guidelines but has been de-emphasized in the 2013 American College of Cardiology/American Heart Association coronary artery disease ( CAD ) guidelines in favor of initiation of statins or triple therapy ( antiplatelet agent , angiotensin converting enzyme inhibitor/angiotensin II receptor blocker , and statins ) .
-BACKGROUND	Our objective was to determine which of these 3 process-of-care metrics achieved within 6 months would be associated with 5-year rates of death , myocardial infarction , or stroke and thus be suitable as an end point for quality improvement studies in patients with CAD .
-METHODS	This was a cohort study that followed 448 participants for 5 years after their involvement in a 6-month secondary prevention trial .
-RESULTS	Over 5 years , 37 patients died , 23 had myocardial infarction , and 20 had stroke .
-RESULTS	Six months after randomization , 125 ( 27.9 % ) had achieved the LDL target ( 2.0 mmol/L ) , 399 ( 89.1 % ) received statins , and 256 ( 57.1 % ) received triple therapy .
-RESULTS	The 5-year composite event rate was significantly lower in patients who achieved the LDL target during the 6-month trial than in those who did not ( 8.8 % vs 17.3 % ; adjusted hazard ratio [ aHR ] , 0.52 ; 95 % confidence interval [ CI ] , 0.27-0 .99 ) , even accounting for statin use ( adjusted P = 0.038 ) .
-RESULTS	Conversely , 5-year event rates were not lower in patients taking statins at 6 months compared with those who were not ( 14.8 % vs 16.3 % ; aHR , 1.23 ; 95 % CI , 0.58-2 .61 ) or in those receiving triple therapy and those who were not ( 14.5 % vs 15.6 % ; aHR , 1.17 ; 95 % CI , 0.71-1 .94 ) .
-CONCLUSIONS	Achievement of LDL targets at 6 months is suitable as a metric for CAD quality-improvement studies ; medication use alone was not independently associated with longer term outcomes .
-
-###24945884
-OBJECTIVE	To determine if a health communication intervention targeting parents of high-risk , urban , minority children with asthma could ( i ) improve parental perceptions of connectedness to and communication with their child 's primary care providers ( PCP ) and ( ii ) decrease reliance on emergency departments ( EDs ) and other urgent care services for their child 's asthma-related care .
-METHODS	The design was a single blind , parallel groups , randomized controlled trial .
-METHODS	Parents were recruited from an ED-based asthma clinic serving primarily low-income , minority children in Washington , DC .
-METHODS	The intervention involved face-to-face education on effective communication followed by a single booster call .
-METHODS	Standardized instruments were administered to assess primary care connectedness and healthcare utilization at baseline and 2 - and 6-months post-enrollment .
-RESULTS	A total of 150 parents of children 1-12 years old were randomized ( 77 intervention and 73 usual care ) , and 137 ( 91 % ) were successfully followed for six months .
-RESULTS	Only at the two-month follow-up time-point , parents in the intervention group were significantly more likely to identify a PCP as the main source of their child 's asthma care ( adjusted odds ratio : 12.6 , 95 % confidence interval : 1.1-142 .1 ) and to report a significant reduction in ED visits for asthma care ( adjusted incidence rate ratio : 0.3 , 95 % confidence interval : 0.1-0 .8 ) .
-RESULTS	There was no significant effect on parent communication self-efficacy or number of PCP visits .
-CONCLUSIONS	A brief , in-person health communication intervention for parents of high-risk children with asthma resulted in improved identification of PCPs as the usual source of asthma care and reduced reliance on EDs for asthma care , albeit only for two months post-intervention .
-
-###25246664
-BACKGROUND	Bronchiectasis is characterised by excessive production of mucus and pulmonary exacerbations .
-BACKGROUND	Inhaled osmotic agents may enhance mucociliary clearance , but few long-term clinical trials have been conducted .
-OBJECTIVE	To determine the impact of inhaled mannitol on exacerbation rates in patients with non-cystic fibrosis ( CF ) bronchiectasis .
-OBJECTIVE	Secondary endpoints included time to first exacerbation , duration of exacerbations , antibiotic use for exacerbations and quality of life ( QOL ) ( St George 's Respiratory Questionnaire , SGRQ ) .
-METHODS	Patients with non-CF bronchiectasis and a history of chronic excess production of sputum and 2 pulmonary exacerbations in the previous 12 months were randomised ( 1:1 ) to 52 weeks treatment with inhaled mannitol 400 mg or low-dose mannitol control twice a day .
-METHODS	Patients were 18-85 years of age , baseline FEV1 40 % and 85 % predicted and a baseline SGRQ score 30 .
-RESULTS	461 patients ( 233 in the mannitol and 228 in the control arm ) were treated .
-RESULTS	Baseline demographics were similar in the two arms .
-RESULTS	The exacerbation rate was not significantly reduced on mannitol ( rate ratio 0.92 , p = 0.31 ) .
-RESULTS	However , time to first exacerbation was increased on mannitol ( HR 0.78 , p = 0.022 ) .
-RESULTS	SGRQ score was improved on mannitol compared with low-dose mannitol control ( -2.4 units , p = 0.046 ) .
-RESULTS	Adverse events were similar between groups .
-CONCLUSIONS	Mannitol 400 mg inhaled twice daily for 12 months in patients with clinically significant bronchiectasis did not significantly reduce exacerbation rates .
-CONCLUSIONS	There were statistically significant improvements in time to first exacerbation and QOL .
-CONCLUSIONS	Mannitol therapy was safe and well tolerated .
-BACKGROUND	NCT00669331 .
-
-###25318000
-OBJECTIVE	To evaluate the pain on injection of propofol via different combinations of fentanyl , sufentanil or remifentanil in gastrointestinal endoscopy .
-METHODS	Total 439 patients were randomly allocated into 6 groups .
-METHODS	Propofol & fentanil ( PF ) group received 1 g/kg fentanyl , propofol & sufentanil ( PS ) group received 0.1 g/kg sufentanil and propofol & remifentanyl ( PR ) group received 1 g/kg remifentanyl prior to administration of 1-2 mg/kg of propofol .
-METHODS	The propofol & half-fentanil ( Pf ) group , propofol & half-sufentanil ( Ps ) group and propofol & half-remifentanyl ( Pr ) group were given 0.5 g/kg fentanyl , 0.05 g/kg sufentanil and 0.5 g/kg remifentanyl , respectively and later administrated 1-2 mg/kg propofol .
-METHODS	All patients were monitored for the blood pressure ( MAP ) , heart rate ( HR ) , and oxygen saturation ( SpO2 ) .
-METHODS	Additionally , the pain intensity was assessed using a 4-point verbal rating scale ( VRS ) by professional doctors .
-RESULTS	The incidence of pain due to propofol injection in Ps group ( 33.8 % ) was significantly lower than other 5 groups .
-RESULTS	The heart rate ( HR ) and mean arterial pressure ( MAP ) were maintained within the normal limits in all six groups and there was no hypotension or bradycardia encountered during the study period .
-CONCLUSIONS	Propofol and sufentanil group was the most suitable program for painless gastroscopy .
-
-###24393414
-BACKGROUND	The use of firocoxib in horses and its ability to affect performance and potential to allow a horse to compete when it otherwise should not , necessitates establishing appropriate withdrawal time guidelines prior to performance .
-OBJECTIVE	To describe plasma concentrations and characterise the pharmacokinetics of 3 firocoxib formulations following multiple administrations of the label dose , with respect to recommended plasma thresholds for performance horses .
-METHODS	Balanced 3-way crossover prospective study .
-METHODS	Nine healthy mature horses were administered firocoxib injectable solution ( 0.09 mg/kg bwt i.v. s.i.d. for 5 days ) , firocoxib paste ( 0.1 mg/kg bwt per os s.i.d. for 14 days ) and firocoxib tablets ( 57mg s.i.d. for 14 days ) .
-METHODS	Blood samples were collected at Time 0 and at various times post drug administration until plasma concentrations were below the limit of detection of the assay .
-METHODS	Plasma samples were analysed using liquid chromatography-mass spectrometry and data analysed using noncompartmental analysis .
-RESULTS	The mean plasma half-life was 1.64 0.737 , 1.70 0.800 and 1.73 0.767 days for injectable , paste and tablet formulations , respectively .
-RESULTS	Plasma concentrations fell below the Racing Medication and Testing Consortium 's recommended threshold for racehorses ( 20ng/ml ) by 7 days post administration of the final dose for all formulations .
-RESULTS	Plasma concentrations never exceeded the threshold concentration ( 240ng/ml ) for horse competing in US Equestrian Federation events for any of the formulations .
-CONCLUSIONS	This study extends current knowledge regarding the pharmacokinetics of firocoxib and provides information that can be used to establish appropriate withdrawal time guidelines following multiple administrations , with respect to already established plasma regulatory threshold concentrations .
-
-###25404142
-BACKGROUND	The study investigated the long-term effectiveness of the adolescent cognitive behavioral resiliency training Op Volle Kracht ( OVK ) on the secondary outcomes : anxiety symptoms , hopelessness , happiness , life satisfaction , optimism , coping , self-efficacy , and school functioning .
-BACKGROUND	In addition , the study analyzed whether the secondary outcomes moderated the intervention effect on depressive symptoms .
-METHODS	A two-condition ( intervention and control ) cluster randomized controlled trial was conducted .
-METHODS	All adolescents in the 8th grade were eligible to participate , unless they , or their parents , declined their participation .
-METHODS	Schools were the unit of randomization .
-METHODS	Missing data were imputed and intent to treat analyses were conducted .
-METHODS	The results were analyzed using Latent Growth Curve Modeling across the 24-months follow-up period .
-RESULTS	The total sample consisted of 1341 adolescents ( Mage = 13.91 , SD = 0.55 , 47.3 % girls , 83.1 % Dutch ethnicity ) .
-RESULTS	The intervention and control condition consisted of 634 adolescents from 4 schools and 707 adolescents from 5 schools , respectively .
-RESULTS	OVK did not have an effect on depression , anxiety , hopelessness , happiness , and life satisfaction , but promoted cognitive coping over the course of the follow-up period .
-RESULTS	OVK showed small iatrogenic effects on optimism , active coping , social self-efficacy and school grades directly post intervention , but these effects disappeared during the follow-up period .
-RESULTS	Finally , none of the outcome variables moderated the intervention effect on depressive symptoms .
-CONCLUSIONS	The universal resiliency training OVK was not effective in this Dutch sample .
-CONCLUSIONS	Implications for research and practice were discussed .
-BACKGROUND	NTR2879 .
-
-###25441065
-BACKGROUND	Minimally invasive surgical procedures ( MIS ) may offer several advantages over conventional full sternotomy ( FS ) aortic valve replacement ( AVR ) .
-BACKGROUND	A novel class of aortic valve prostheses has been developed for rapid-deployment AVR ( RDAVR ) .
-BACKGROUND	We report a randomized , multicenter trial comparing the outcomes for MIS-RDAVR with those of conventional FS-AVR .
-METHODS	A total of 100 patients with aortic stenosis were enrolled in a prospective , multicenter , randomized comparison trial ( CADENCE-MIS ) .
-METHODS	Exclusion criteria included ejection fraction below 25 % , AVR requiring concomitant procedures , and recent myocardial infarction or stroke .
-METHODS	Patients were randomized to undergo MIS-RDAVR through an upper hemisternotomy ( n = 51 ) or AVR by FS with a conventional stented bioprosthesis ( n = 49 ) .
-METHODS	Three patients were excluded before the procedure , and 3 more patients who were randomized to undergo RDAVR were excluded because of their anatomy .
-METHODS	Procedural , early clinical outcomes , and functional outcomes were assessed for the remaining 94 patients .
-METHODS	Hemodynamic performance was assessed by an echocardiography core laboratory .
-RESULTS	Implanted valve sizes were similar between groups ( 22.9 2.1 vs 23.0 2.1 mm , p = 0.9 ) .
-RESULTS	MIS-RDAVR was associated with significantly reduced aortic cross-clamp times compared with FS-AVR ( 41.3 20.3 vs 54.0 20.3 minutes , p < 0.001 ) , although cardiopulmonary bypass times were similar ( 68.8 29.0 vs 74.4 28.4 minutes , p = 0.21 ) .
-RESULTS	Early clinical outcomes were similar between the two groups , including quality of life measures .
-RESULTS	The RDAVR patients had a significantly lower mean transvalvular gradient ( 8.5 vs 10.3 mm Hg , p = 0.044 ) and a lower prevalence of patient-prosthesis mismatch ( 0 % vs 15.0 % , p = 0.013 ) 3 months postoperatively compared with the FS-AVR patients .
-CONCLUSIONS	RDAVR by the MIS approach is associated with significantly reduced myocardial ischemic time and better valvular hemodynamic function than FS-AVR with a conventional stented bioprosthesis .
-CONCLUSIONS	Rapid deployment valves may facilitate the performance of MIS-AVR .
-
-###25555887
-OBJECTIVE	We aim to examine predictors of opiate abstinence status 3 months after the end of buprenorphine/naloxone treatment for opioid-dependent participants .
-METHODS	Participants ( n = 516 , age > 15 years ) received buprenorphine / naloxone treatment for 4 weeks and then randomly assigned to undergo dose tapering over either 7 days or 28 days .
-METHODS	Bivariate analysis was performed to identify possible predictors of successful opiate abstinence outome ( p-value < 0.10 ) .
-METHODS	Logistic regression analysis with backward stepwise selection was , then , performed to produce final model containing independent predictors at p-value < 0.05 .
-RESULTS	Bivariate analysis identified several possible predictors including : opioid and drug urine tests result at the end taper ; employment status , family problems , and alcohol use domains of addiction severity index ( ASI ) score ; and clinical opiate withdrawal scale ( COWS ) at the end of stabilization .
-RESULTS	Final predictor list identified by logistic regression include : ASI score for family and alcohol problems , COWS at the end of stabilization and opiate urine test at the end of taper .
-CONCLUSIONS	Participants presenting with a negative urine test for opiate , more severe alcohol , more severe family problems , or more symptoms of opiate withdrawal at the end of stabilization were more likely to have a successful opiate abstinence .
-
-###26176357
-BACKGROUND	The anxiolytic efficacy of video watching , in the absence of parents , during the mask induction of anesthesia in young children with high separation anxiety has not been clearly established .
-BACKGROUND	We performed this study to determine whether the effect of video distraction on alleviating preoperative anxiety is independent of parental presence and whether a combination of both interventions is more effective than either single intervention in alleviating preoperative anxiety and postoperative behavioral disturbance in preschool children .
-METHODS	In this prospective trial , 117 children aged 2 to 7 years scheduled for elective minor surgery were randomly allocated to 1 of 3 groups , a video distraction group ( group V ) , a parental presence group ( group P ) , or a combination of video distraction plus parental presence group ( group VP ) during induction of sevoflurane anesthesia .
-METHODS	The Modified Yale Preoperative Anxiety Scale ( mYPAS ) was used to assess anxiety in the preoperative holding area ( baseline ) , immediately after entry to the operating room , and during mask induction .
-METHODS	Compliance during induction , emergence delirium during recovery , and negative behavioral changes at 1 day and 2 weeks postoperatively were also assessed .
-RESULTS	The mYPAS scores were comparable ( P = 0.558 ) , and the number of children exhibiting baseline anxiety ( an mYPAS score > 30 ) were not different among the 3 groups in the preoperative holding area ( P = 0.824 ) .
-RESULTS	After intervention , the changes in mYPAS scores from baseline to induction were not different among the 3 groups ( P = 0.049 ) .
-RESULTS	The proportion of children with increased mYPAS scores was higher in group P compared with group V from baseline to operating room entry ( Bonferroni-adjusted 95 % confidence interval for difference , 2 to 49 ) but similar from baseline to induction in all 3 groups .
-RESULTS	Although children in group V were more cooperative during mask induction than those in the other 2 groups ( P < 0.001 versus group P and P = 0.001 versus group VP ) , no significant intergroup differences were observed in the incidence of emergence delirium or new-onset negative behavioral change after surgery .
-CONCLUSIONS	Video distraction , parental presence , or their combination showed similar effects on preoperative anxiety during inhaled induction of anesthesia and postoperative behavioral outcomes in preschool children having surgery .
-
-###24967362
-OBJECTIVE	Methotrexate ( MTX ) , the most used drug in rheumatoid arthritis ( RA ) treatment , showing variability in clinical response , is often associated with genetic polymorphisms .
-OBJECTIVE	This study aimed to elucidate the role of methylenetetrahydrofolate reductase ( MTHFR ) C677T and aminoimidazole carboxamide adenosine ribonucleotide transformylase ( ATIC ) T675C polymorphisms and clinicopathological variables in clinical response to MTX in Portuguese RA patients .
-METHODS	Study included 233 RA patients treated with MTX for at least six months .
-METHODS	MTHFR C677T and ATIC T675C polymorphisms were genotyped and clinicopathological variables were collected .
-METHODS	Statistical analyses were performed and binary logistic regression method adjusted to possible confounding variables .
-RESULTS	Multivariate analyses demonstrated that MTHFR 677TT ( OR = 4.63 ; P = 0.013 ) and ATIC 675T carriers ( OR = 5.16 ; P = 0.013 ) were associated with over 4-fold increased risk for nonresponse .
-RESULTS	For clinicopathological variables , noncurrent smokers ( OR = 7.98 ; P = 0.001 ) , patients positive to anti-cyclic citrullinated peptide ( OR = 3.53 ; P = 0.004 ) and antinuclear antibodies ( OR = 2.28 ; P = 0.045 ) , with higher health assessment questionnaire score ( OR = 2.42 ; P = 0.007 ) , and nonsteroidal anti-inflammatory drug users ( OR = 2.77 ; P = 0.018 ) were also associated with nonresponse .
-RESULTS	Contrarily , subcutaneous administration route ( OR = 0.11 ; P < 0.001 ) was associated with response .
-CONCLUSIONS	Our study suggests that MTHFR C677T and ATIC T675C genotyping combined with clinicopathological data may help to identify patients whom will not benefit from MTX treatment and , therefore , assist clinicians in personalizing RA treatment .
-
-###24725239
-BACKGROUND	In phase 2 studies , treatment with the all-oral combination of the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor ledipasvir resulted in high rates of sustained virologic response among previously untreated patients with hepatitis C virus ( HCV ) genotype 1 infection .
-METHODS	We conducted a phase 3 , open-label study involving previously untreated patients with chronic HCV genotype 1 infection .
-METHODS	Patients were randomly assigned in a 1:1:1:1 ratio to receive ledipasvir and sofosbuvir in a fixed-dose combination tablet once daily for 12 weeks , ledipasvir-sofosbuvir plus ribavirin for 12 weeks , ledipasvir-sofosbuvir for 24 weeks , or ledipasvir-sofosbuvir plus ribavirin for 24 weeks .
-METHODS	The primary end point was a sustained virologic response at 12 weeks after the end of therapy .
-RESULTS	Of the 865 patients who underwent randomization and were treated , 16 % had cirrhosis , 12 % were black , and 67 % had HCV genotype 1a infection .
-RESULTS	The rates of sustained virologic response were 99 % ( 95 % confidence interval [ CI ] , 96 to 100 ) in the group that received 12 weeks of ledipasvir-sofosbuvir ; 97 % ( 95 % CI , 94 to 99 ) in the group that received 12 weeks of ledipasvir-sofosbuvir plus ribavirin ; 98 % ( 95 % CI , 95 to 99 ) in the group that received 24 weeks of ledipasvir-sofosbuvir ; and 99 % ( 95 % CI , 97 to 100 ) in the group that received 24 weeks of ledipasvir-sofosbuvir plus ribavirin .
-RESULTS	No patient in either 12-week group discontinued ledipasvir-sofosbuvir owing to an adverse event .
-RESULTS	The most common adverse events were fatigue , headache , insomnia , and nausea .
-CONCLUSIONS	Once-daily ledipasvir-sofosbuvir with or without ribavirin for 12 or 24 weeks was highly effective in previously untreated patients with HCV genotype 1 infection .
-CONCLUSIONS	( Funded by Gilead Sciences ; ION-1 ClinicalTrials.gov number NCT01701401 . )
-
-###25297681
-OBJECTIVE	Providing effective analgesia for total knee arthroplasty ( TKA ) patients remains challenging .
-OBJECTIVE	Femoral nerve block ( FNB ) offers targeted pain control ; however , its effect on motor function , related fall risk and impact on rehabilitation has been the source of controversy .
-OBJECTIVE	Adductor canal block ( ACB ) potentially spares motor fibres of the femoral nerve , but the comparative effect of the two approaches has not yet been well defined due to considerable variability in pain perception .
-OBJECTIVE	Our study compares both single-shot FNB and ACB , side to side , in the same patients undergoing bilateral TKA .
-METHODS	Sixty patients scheduled for bilateral TKA were randomised to receive ultrasound-guided FNB on one leg and ACB on the other , in addition to combined spinal epidural anaesthesia .
-METHODS	The primary outcome was comparative postoperative pain in either extremity at six to eight , 24 and 48 hours postoperatively .
-METHODS	Secondary comparative outcomes included motor strength ( manually and via dynamometer ) , physical therapy milestones and patient satisfaction .
-RESULTS	While pain levels were lowest at six to eight hours postoperatively and increased thereafter ( P < 0.001 ) , no significant differences were seen between extremities at any time point with regard to pain in the quantitative comparison using visual analogue scale ( VAS ) scores ( P = 0.4154 ) , motor strength ( P = 0.7548 ) , physical therapy milestones or patient satisfaction .
-RESULTS	However , in the qualitative comparison , a significant proportion of patients reported the leg receiving ACB to be more painful than that receiving FNB at 24 h [ 50.9 % ( n = 30 ) vs 25.42 % ( n = 15 ) , P = 0.0168 ) ] .
-CONCLUSIONS	Although we could not confirm a benefit in motor function between ACB and FNB , given the equivalent analgesic potency combined with its potentially lower overall impact if neuropraxia should occur , ACB may represent an attractive alternative to FNB .
-
-###25002671
-OBJECTIVE	To assess the effectiveness of in-person and webinar-delivered AFIX ( Assessment , Feedback , Incentives , and eXchange ) consultations for increasing adolescent vaccine coverage .
-METHODS	We randomly assigned 91 primary care clinics in North Carolina , serving 107443 adolescents , to receive no consultation or an in-person or webinar AFIX consultation .
-METHODS	We delivered in-person consultations in April through May 2011 and webinar consultations in May through August 2011 .
-METHODS	The state 's immunization registry provided vaccine coverage data for younger patients ( ages 11-12 years ) and older patients ( ages 13-18 years ) for 3 adolescent vaccines : tetanus toxoid , reduced diphtheria toxoid , and acellular pertussis ( Tdap ) ; meningococcal ; and human papillomavirus ( HPV ) vaccines ( 1 dose , females only ) .
-RESULTS	At the 5-month follow-up , AFIX consultations increased vaccine coverage among younger adolescents .
-RESULTS	Patients in the in-person arm experienced coverage changes that exceeded those in the control arm for Tdap ( 3.4 % [ 95 % confidence interval ( CI ) : 2.2 to 4.6 ] ) , meningococcal ( 4.7 % [ 95 % CI : 2.3 to 7.2 ] , and HPV ( 1.5 % [ 95 % CI : 0.3 to 2.7 ] ) vaccines .
-RESULTS	Patients in the webinar versus control arm also experienced larger changes for these vaccines .
-RESULTS	AFIX did little to improve coverage among older adolescents .
-RESULTS	At 1 year , the 3 arms showed similar coverage changes .
-RESULTS	The effectiveness of in-person and webinar consultations was not statistically different at either time point ( all , P > .05 ) .
-CONCLUSIONS	Webinar AFIX consultations were as effective as in-person consultations in achieving short-term increases in vaccine coverage for younger adolescents .
-CONCLUSIONS	AFIX consultations for adolescents need improvement to have a stronger and more durable impact , especially for HPV vaccine .
-
-###25599904
-BACKGROUND	With increasing evidence demonstrating the effectiveness of Web-based interventions and mindfulness-based training in improving health , delivering mindfulness training online is an attractive proposition .
-OBJECTIVE	The aim of this study was to evaluate the efficacy of two Internet-based interventions ( basic mindfulness and Health Action Process Approach enhanced mindfulness ) with waitlist control .
-OBJECTIVE	Health Action Process Approach ( HAPA ) principles were used to enhance participants ' efficacy and planning .
-METHODS	Participants were recruited online and offline among local universities ; 321 university students and staff were randomly assigned to three conditions .
-METHODS	The basic and HAPA-enhanced groups completed the 8-week fully automated mindfulness training online .
-METHODS	All participants ( including control ) were asked to complete an online questionnaire pre-program , post-program , and at 3-month follow-up .
-RESULTS	Significant group by time interaction effect was found .
-RESULTS	The HAPA-enhanced group showed significantly higher levels of mindfulness from pre-intervention to post-intervention , and such improvement was sustained at follow-up .
-RESULTS	Both the basic and HAPA-enhanced mindfulness groups showed better mental well-being from pre-intervention to post-intervention , and improvement was sustained at 3-month follow-up .
-CONCLUSIONS	Online mindfulness training can improve mental health .
-CONCLUSIONS	An online platform is a viable medium to implement and disseminate evidence-based interventions and is a highly scalable approach to reach the general public .
-BACKGROUND	Chinese Clinical Trial Registry ( ChiCTR ) : ChiCTR-TRC-12002954 ; http://www.chictr.org/en/proj/show.aspx?proj=3904 ( Archived by WebCite at http://www.webcitation.org/6VCdG09pA ) .
-
-###25659140
-OBJECTIVE	Skin temperature assessment has historically been undertaken with conductive devices affixed to the skin .
-OBJECTIVE	With the development of technology , infrared devices are increasingly utilised in the measurement of skin temperature .
-OBJECTIVE	Therefore , our purpose was to evaluate the agreement between four skin temperature devices at rest , during exercise in the heat , and recovery .
-METHODS	Mean skin temperature ( [ Formula : see text ] ) was assessed in thirty healthy males during 30 min rest ( 24.0 1.2 C , 56 8 % ) , 30 min cycle in the heat ( 38.0 0.5 C , 41 2 % ) , and 45 min recovery ( 24.0 1.3 C , 56 9 % ) .
-METHODS	[ Formula : see text ] was assessed at four sites using two conductive devices ( thermistors , iButtons ) and two infrared devices ( infrared thermometer , infrared camera ) .
-RESULTS	Bland-Altman plots demonstrated mean bias limits of agreement between the thermistors and iButtons as follows ( rest , exercise , recovery ) : -0.01 0.04 , 0.26 0.85 , -0.37 0.98 C ; thermistors and infrared thermometer : 0.34 0.44 , -0.44 1.23 , -1.04 1.75 C ; thermistors and infrared camera ( rest , recovery ) : 0.83 0.77 , 1.88 1.87 C. Pairwise comparisons of [ Formula : see text ] found significant differences ( p < 0.05 ) between thermistors and both infrared devices during resting conditions , and significant differences between the thermistors and all other devices tested during exercise in the heat and recovery .
-CONCLUSIONS	These results indicate poor agreement between conductive and infrared devices at rest , during exercise in the heat , and subsequent recovery .
-CONCLUSIONS	Infrared devices may not be suitable for monitoring [ Formula : see text ] in the presence of , or following , metabolic and environmental induced heat stress .
-
-###24345601
-OBJECTIVE	This study examined the effectiveness of a fully automated web-based programme to increase physical activity in adults with Type 2 diabetes .
-METHODS	Between May and July 2010 , participants were randomly allocated into either a 12-week intervention ( n = 195 ) or a control ( n = 202 ) group .
-METHODS	Participants were adults diagnosed with Type 2 diabetes , residing in Australia .
-METHODS	Participants were assessed at baseline , 12 and 36weeks .
-METHODS	The primary physical activity outcome was self-reported minutes of total physical activity .
-METHODS	Secondary physical activity outcomes included minutes spent walking , and engaged in moderate , and vigorous physical activity .
-METHODS	Additional measures included website satisfaction and website usage .
-METHODS	The intervention consisted of a 12-week web-based physical activity intervention developed based on the Theory of Planned Behavior and self-management framework .
-METHODS	Data were analysed from 2011 to 2012 .
-RESULTS	There was a significant group-by-time interaction ( X ( 2 ) ( df = 1 ) = 6.37 , p < .05 ) for total physical activity favouring the intervention group d = 0.11 , for those who completed the intervention , however this was not significant in the intention-to-treat analysis d = 0.01 .
-RESULTS	The intervention yielded high website satisfaction and usage .
-CONCLUSIONS	In general , there is some evidence for the effectiveness of web-based interventions for improving physical activity levels ; however it is clear that maintaining improvements remains an issue .
-
-###24322433
-OBJECTIVE	The aim of this study was to compare whether the effectiveness of continuous ultrasound ( US ) was superior against pulsed US and against sham US in knee osteoarthritis .
-METHODS	A randomized controlled study was carried out on 60 patients diagnosed with knee osteoarthritis according to American College of Rheumatology .
-METHODS	The patients were randomized into the following three treatments : ( 1 ) continuous US ( at a frequency of 1 MHz with intensity of 1 W/cm ) , ( 2 ) pulse US ( same frequency and intensity on 1:4 pulse ratio ) , and ( 3 ) sham US .
-METHODS	All treatments were applied with 5-cm head US device five times a week for 2 weeks in addition to home exercise program including quadriceps isometric exercise , muscle strength exercises , and stretching exercises of the lower extremity muscles for at least three times per week .
-METHODS	Assessments were performed at baseline , at the end of the treatment , and at the end of the treatments and at the sixth month using the following measurements : Western Ontario and McMaster University Osteoarthritis Index-pain , stiffness , function , visual analog scale-pain at rest , visual analog scale-pain on movement , visual analog scale-disease severity , and 20-m walking time .
-METHODS	Among these parameters , the Western Ontario and McMaster University Osteoarthritis Index-pain was the primary outcome .
-RESULTS	All groups showed a significant improvement in all parameters in both following visits ( P < 0.05 ) .
-RESULTS	However , there was no significant difference between the groups .
-RESULTS	Although the mean reduction percent in Western Ontario and McMaster University Osteoarthritis Index-pain was significantly higher in group I ( continuous US ) when compared to sham group ( 46.5 % vs 28.9 % , P < 0.05 ) at the end of the treatment , this result was not found in other pain parameters .
-CONCLUSIONS	The present study demonstrated that all assessment parameters significantly improved in all groups without a significant difference .
-CONCLUSIONS	This result suggested that therapeutic US provided no additional benefit in improving pain and functions in addition to exercise training .
-
-###24650828
-OBJECTIVE	Several definitions of treatment response have been proposed for alcohol clinical trials ( e.g. , abstinence and no heavy drinking ) .
-OBJECTIVE	However , each of these outcomes allows only one definition of successful response .
-OBJECTIVE	In contrast , the cumulative proportion of responders analysis ( CPRA ) includes all of the possible drinking response cutoff points , providing a more complete picture of the therapeutic effects of a treatment .
-OBJECTIVE	CPRA has been used to examine the efficacy of analgesics but not alcohol pharmacotherapy .
-OBJECTIVE	To demonstrate its potential utility , we conducted CPRA in two large alcohol treatment trials : the COMBINE ( Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence ) trial ( naltrexone ) and a multisite topiramate trial .
-OBJECTIVE	CPRA was used to demonstrate the efficacy of naltrexone and topiramate on continuous measures of in-treatment drinking-heavy drinking days and drinks per day-and their reductions from pretreatment .
-METHODS	All possible cutoff points were portrayed for each measure .
-METHODS	We provide graphs to illustrate the effects of the active medications compared with placebo and examined them statistically over a number of salient drinking outcomes to evaluate their efficacy .
-RESULTS	Treatment group responder curves were not parallel across the entire range of cutoff points ; rather , they separated only at lower levels of drinking .
-RESULTS	In general , effect sizes increased by 0.10-0 .15 when going from the lowest drinking level cutoff ( i.e. , abstinence and no heavy drinking ) to the cutoff associated with the maximal treatment effect .
-CONCLUSIONS	CPRA may be useful in designing subsequent trials and helping to illustrate for treatment providers the likelihood of treatment success given various definitions of a positive response .
-
-###26434249
-BACKGROUND	Hypertriglyceridemia is one of the risk factors for cardiovascular disease , and reduction oftriglyceride ( TG ) level is recommended in clinical practice guidelines for the treatment .
-BACKGROUND	Recently , andrographolide , a main active compound of Andrographispaniculata has been shown to possess hypolipidemic effects in animals .
-OBJECTIVE	To investigate the TG-lowering effects of A. paniculata extract ( APE ) in patients with hypertriglyceridemia ( TG 150 mg/dL ) using gemfibrozil treatment as the reference .
-METHODS	A randomized controlled clinical trial was carried out in sixty subjects with hypertriglyceridemia .
-METHODS	They were divided into three groups and treated with low dose of APE ( APE-L , andrographolide 71.64-72 .36 mg/day ) , high dose of APE ( APE-H , andrographolide 119.64-120 .36 mg/day ) , and gemfibrozil 300 mg/day .
-METHODS	The treatments were conducted for 8 weeks .
-METHODS	Guidance on lifestyle modifications was provided .
-RESULTS	The primary endpoint was the mean difference SD ( 95 % CI ) in TG levels ( baseline from the end of treatment ) , which were -3 125.6 ( -59.1 , 58.5 ) , 41.6 86.3 ( 1.2 , 82 ) , and 57.1 94.9 ( 12.7 , 101.6 ) in the APE-L , APE-H , and gemfibrozil groups , respectively .
-RESULTS	APE-H 120 mg/day and gemfibrozil 300 mg/day caused a significant reduction of TG level ( P = 0.0442 and 0.0145 , respectively ) when compared to the baseline .
-RESULTS	There was no notable difference in the safety or tolerability among the treatment groups .
-CONCLUSIONS	In patients with modest hypertriglyceridemia with lifestyle intervention , APE-H reduced the TG level comparable to the effect of gemfibrozil 300 mg/day .
-CONCLUSIONS	APE treatment was as tolerable as gemfibrozil treatment .
-CONCLUSIONS	Hence , Andrographis paniculata might be used as an alternative medicine in treating hypertriglyceridemic patients .
-
-###24286456
-BACKGROUND	Several chemokines , notably eotaxin , mediate the recruitment of eosinophils into tissues via the CCR3 receptor .
-OBJECTIVE	In this study , we investigated the role of CCR3 agonists in asthma by observing the effect of a small molecule antagonist of the CCR3 receptor ( GW766994 ) on sputum eosinophil counts in patients with eosinophilic asthma .
-METHODS	Clinical and physiological outcomes , the chemotactic activity of sputum supernatant for eosinophils and the presence of eosinophil progenitors in sputum and blood samples were also studied .
-RESULTS	In a double-blind parallel group study , 60 patients with asthma were randomized to 300 mg of GW766994 twice daily or matching placebo for 10 days followed by prednisone 30 mg for 5 days .
-RESULTS	Of these patients , 53 had a sputum eosinophil count > 4.9 % at baseline .
-RESULTS	Despite plasma concentrations of drug consistent with > 90 % receptor occupancy during the dosing period , the CCR3 antagonist did not significantly reduce eosinophils or eosinophil progenitor cells ( CD34 ( + ) 45 ( + ) IL-5R ( + ) ) in sputum or in blood .
-RESULTS	The ex vivo chemotactic effect of sputum supernatants on eosinophils was attenuated by GW766944 compared to placebo .
-RESULTS	There was no improvement in FEV1 ; however , there was a modest but statistically significant improvement in PC20 methacholine ( 0.66 doubling dose ) and ACQ scores , ( 0.43 ) .
-RESULTS	Whilst the improvement in PC20 is statistically significant , it is not of clinical significance .
-CONCLUSIONS	In conclusion , this study calls into question the role of CCR3 in airway eosinophilia in asthma and suggests that other cellular mechanisms mediated by the CCR3 receptor may contribute to airway hyperresponsiveness .
-
-###24689456
-BACKGROUND	Current evidence suggests that many patients with self-reported non-coeliac gluten sensitivity ( NCGS ) retain gastrointestinal symptoms on a gluten-free diet ( GFD ) but continue to restrict gluten as they report ` feeling better ' .
-OBJECTIVE	To investigate the notion that a major effect of gluten in those with NCGS is on mental state and not necessarily on gastrointestinal symptoms .
-METHODS	Twenty-two subjects ( 24-62 years , five male ) with irritable bowel syndrome who had coeliac disease excluded but were symptomatically controlled on a GFD , undertook a double-blind cross-over study .
-METHODS	Participants randomly received one of three dietary challenges for 3 days , followed by a minimum 3-day washout before crossing over to the next diet .
-METHODS	Challenge gluten-free food was supplemented with gluten ( 16 g/day ) , whey ( 16 g/day ) or not supplemented ( placebo ) .
-METHODS	End-points included mental state as assessed by the Spielberger State Trait Personality Inventory ( STPI ) , cortisol secretion and gastrointestinal symptoms .
-RESULTS	Gluten ingestion was associated with higher overall STPI state depression scores compared to placebo [ M = 2.03 , 95 % CI ( 0.55-3 .51 ) , P = 0.010 ] but not whey [ M = 1.48 , 95 % CI ( -0.14 to 3.10 ) , P = 0.07 ] .
-RESULTS	No differences were found for other STPI state indices or for any STPI trait measures .
-RESULTS	No difference in cortisol secretion was identified between challenges .
-RESULTS	Gastrointestinal symptoms were induced similarly across all dietary challenges .
-CONCLUSIONS	Short-term exposure to gluten specifically induced current feelings of depression with no effect on other indices or on emotional disposition .
-CONCLUSIONS	Gluten-specific induction of gastrointestinal symptoms was not identified .
-CONCLUSIONS	Such findings might explain why patients with non-coeliac gluten sensitivity feel better on a gluten-free diet despite the continuation of gastrointestinal symptoms .
-
-###24554074
-OBJECTIVE	Concomitant carotid and cardiac surgery carries an increased perioperative morbidity and mortality risk .
-OBJECTIVE	Whether the hybrid procedure of carotid artery stenting ( CAS ) and coronary bypass surgery decreases the risk of stroke and other complications is still unknown .
-OBJECTIVE	The aim of this study was to assess early outcomes after simultaneous hybrid CAS and coronary bypass grafting versus open concomitant carotid and coronary bypass surgery .
-METHODS	We included 20 patients in this study .
-METHODS	According to the protocol , all the patients were divided into two groups : Group 1 ( 10 patients ) with hybrid CAS and coronary bypass surgery and Group 2 ( 10 patients ) with concomitant carotid and coronary surgery .
-METHODS	Different preoperative , intraoperative and postoperative variables were compared .
-METHODS	The primary end point was combined incidence of stroke and death 30 days after surgery or during initial hospitalization .
-METHODS	The secondary end points were myocardial infarction , atrial fibrillation , blood loss and need for blood transfusion and duration of intensive care unit and hospital stay .
-RESULTS	Groups 1 and 2 were similar in preoperative characteristics including age ( 65.3 6.8 vs 70.7 7.0 , P = 0.191 ) New York Heart Association class ( 2.3 0.5 vs 1.8 0.7 , P = 0.218 ) , EuroSCORE ( 2.8 2.0 vs 3.6 2.3 , P = 0.547 ) , the degree of carotid stenosis ( 79 12 vs 87 13 % , P = 0.224 ) and average left ventricular ejection fraction ( 44.3 12.4 vs 43.4 13.3 % , P = 0.896 ) .
-RESULTS	Also , the groups did not differ in intraoperative variables with an exception of extracorporeal circulation time ( 65.7 14.1 vs 90.0 + 17.4 min , P = 0.023 ) , which was significantly shorter in Group 1 .
-RESULTS	Although rare , and without significant difference , primary end point occurred only in Group 2 ( 1 stroke and 1 death , 20 % ) .
-RESULTS	There was no difference in the duration of mechanical ventilation , need for transfusion and duration of intensive care unit and hospital stay between the two groups .
-CONCLUSIONS	Although limited by a small sample size , our results show that the hybrid procedure of carotid stenting and coronary surgery might be a good therapeutic option but further extended studies are needed to assess its real value .
-
-###25265151
-BACKGROUND	Reduced estimated glomerular filtration rate ( eGFR ) using the cystatin-C derived equations might be a better predictor of cardiovascular disease ( CVD ) mortality compared with the creatinine-derived equations , but this association remains unclear in elderly individuals .
-OBJECTIVE	The aims of this study were to compare the predictive values of the Chronic Kidney Disease Epidemiology Collaboration ( CKD-EPI ) - creatinine , CKD-EPI-cystatin C and CKD-EPI-creatinine-cystatin C eGFR equations for all-cause mortality and CVD events ( hospitalizationsmortality ) .
-METHODS	Prospective cohort study of 1165 elderly women aged > 70 years .
-METHODS	Associations between eGFR and outcomes were examined using Cox regression analysis .
-METHODS	Test accuracy of eGFR equations for predicting outcomes was examined using Receiver Operating Characteristic ( ROC ) analysis and net reclassification improvement ( NRI ) .
-RESULTS	Risk of all-cause mortality for every incremental reduction in eGFR determined using CKD-EPI-creatinine , CKD-EPI-cystatin C and the CKD-EPI-creatinine-cystatic C equations was similar .
-RESULTS	Areas under the ROC curves of CKD-EPI-creatinine , CKD-EPI-cystatin C and CKD-EPI-creatinine-cystatin C equations for all-cause mortality were 0.604 ( 95 % CI 0.561-0 .647 ) , 0.606 ( 95 % CI 0.563-0 .649 ; p = 0.963 ) and 0.606 ( 95 % CI 0.563-0 .649 ; p = 0.894 ) respectively .
-RESULTS	For all-cause mortality , there was no improvement in the reclassification of eGFR categories using the CKD-EPI-cystatin C ( NRI -4.1 % ; p = 0.401 ) and CKD-EPI-creatinine-cystatin C ( NRI -1.2 % ; p = 0.748 ) compared with CKD-EPI-creatinine equation .
-RESULTS	Similar findings were observed for CVD events .
-CONCLUSIONS	eGFR derived from CKD-EPI cystatin C and CKD-EPI creatinine-cystatin C equations did not improve the accuracy or predictive ability for clinical events compared to CKD-EPI-creatinine equation in this cohort of elderly women .
-
-###24405492
-BACKGROUND	The ASPIRE in-clinic study established that automatic suspension of insulin with the threshold suspend ( TS ) feature reduces the duration of induced hypoglycemia .
-BACKGROUND	The study 's crossover design allowed the effects of antecedent hypoglycemia to be studied .
-METHODS	The study enrolled 50 subjects who exercised until plasma glucose ( YSI glucose and lactate analyzer ; YSI , Inc. , Yellow Springs , OH ) reached 85 mg/dL .
-METHODS	Hypoglycemia was evaluated after the YSI value reached < 70 mg/dL .
-METHODS	In TS experiments , insulin was stopped for 2 h once a sensor glucose ( SG ) value of 70 mg/dL was detected ; in control experiments , basal insulin delivery continued .
-METHODS	Subjects were randomly assigned to Group A ( TS in Period 1 ; control in Period 2 ) or Group B ( control in Period 1 ; TS in Period 2 ) .
-METHODS	Experiments were separated by 3-10 days .
-RESULTS	Hypoglycemia was 63.7 min shorter in Period 1 TS experiments ( no preceding control experiment ) than in Period 2 TS experiments ( one or more preceding control experiment ( s ) ) ( P < 0.01 ) .
-RESULTS	The number of experiments prior to a successful TS experiment was lower for Period 1 than for Period 2 ( 0.36 0.64 vs. 1.57 0.84 ; P < 0.001 ) , as was the cumulative duration of antecedent hypoglycemia ( 16.6 min vs. 204.6 min ; P < 0.001 ) .
-RESULTS	The between-groups difference in hypoglycemia duration was not attributable to differences in SG rates of change , the duration of exercise , or area under the curve of < 70 mg/dL min in the 2 days before the successful experiment ( all P > 0.3 ) .
-CONCLUSIONS	The TS feature 's ability to mitigate hypoglycemia was decreased by an episode or episodes of prolonged antecedent hypoglycemia , suggesting hypoglycemia begets hypoglycemia .
-CONCLUSIONS	The effect of antecedent hypoglycemia should be taken into consideration in the design of future experiments assessing strategies to reduce hypoglycemia .
-
-###24660647
-OBJECTIVE	Low-level laser therapy has still not been well established , and it is important to define a standardized protocol for the treatment of temporomandibular disorders ( TMDs ) using low level laser .
-OBJECTIVE	There is no consensus on controlled clinical trials concerning the best option for laser therapy with regard to wavelength .
-OBJECTIVE	The aim of this study was to evaluate the efficacy of red and infrared laser therapy in patients with TMD , using a randomized parallel-group double-blind trial .
-METHODS	Each hemiface of 19 subjects was randomized to receive intervention , in a total of 116 sensitive points .
-METHODS	Pain was measured at baseline and time intervals of 24 hours , 30 days , 90 days , and 180 days after treatment .
-METHODS	Irradiation of 4 J/cm2 in the temporomandibular joints and 8 J/cm ( 2 ) in the muscles was used in three sessions .
-RESULTS	Both treatments had statistically significant results ( P < 0.001 ) ; there was statistical difference between them at 180 days in favor of the infrared laser ( P = 0.039 ) .
-RESULTS	There was improvement in 24 hours , which extended up to 180 days in both groups .
-CONCLUSIONS	Both lasers are effective in the treatment and remission of TMD symptoms .
-
-###25432000
-OBJECTIVE	Extensive discussion with renal patients about treatment intensity is not systematically integrated into their care and often occurs during an acute hospitalization .
-OBJECTIVE	We conducted a `` test-of-change '' pilot study to assess the utility of providing an upstream discussion in the ambulatory setting as an additional nephrology consult to assist patients with chronic kidney disease considering treatment choices .
-METHODS	We randomly assigned patients with Stage 4 or Stage 5 chronic kidney disease who had not yet begun renal dialysis to 1 of 2 groups .
-METHODS	The test group received the additional nephrology consult and met with an interdisciplinary team composed of a nephrologist , social worker , and clinical ethicist , and the control group did not .
-METHODS	Qualitative data were collected in 2012 and 2013 via oral questionnaire .
-METHODS	Both groups received a 6-month follow-up assessment .
-RESULTS	Patients who received the nephrology consult reported that they experienced help in forming a treatment plan , felt well understood , and had the opportunity to thoroughly discuss questions .
-RESULTS	The controls had a 26 % increased probability of beginning dialysis and had a statistically significant increase in dialysis and clinic visits ( p < 0.10 and p < 0.05 ) .
-RESULTS	Controls also were likelier than the test group to be admitted to the hospital ( 0.5 vs 0.2 admissions per patient in the test group ) , spend more days hospitalized ( 2.8 vs 0.5 bed days per patient ) , and visit the emergency room ( 0.73 vs 0.66 visits per patient ) and clinic ( 6.6 vs 3.6 visits per patient ) .
-CONCLUSIONS	An additional nephrology consultation proved helpful both qualitatively and quantitatively .
-
-###24501162
-BACKGROUND	The metabolic syndrome is the most important risk factor for cardiovascular disease .
-BACKGROUND	The heat shock proteins ( HSPs ) are highly conserved families of proteins expressed by a number of cell types following exposure to stressful environmental conditions include several known risk factors for cardiovascular disease .
-BACKGROUND	Recent studies have shown the potential of constituents of saffron in the treatment of atherosclerosis .
-BACKGROUND	We aimed on investigating the effect of saffron on antibody titers to HSP in patients with metabolic syndrome .
-METHODS	This was a randomized , placebo-controlled clinical trial .
-METHODS	One-hundred and five subjects with metabolic syndrome were randomly allocated to one of the three groups : the case group received 100 mg/day saffron , the placebo control group received a capsule of placebo and a non-placebo control group received no capsule , for 12 weeks .
-RESULTS	Antibodies against heat shock proteins 27 , 60 , 65 and 70 were determined in all patients before ( week 0 ) and after ( week 6 and 12 ) intervention .
-RESULTS	At 12 weeks , saffron produced a significantly decrease in AntiHSP27 , 70 levels .
-RESULTS	Saffron can decrease AntiHSP27 , 70 levels in patients with metabolic syndrome .
-CONCLUSIONS	The results of this study indicate the efficacy of saffron in the improvement of some markers of autoimmunity HSPs in patients with metabolic syndrome .
-
-###25302772
-OBJECTIVE	The objective of this longitudinal study was to determine what typical vitamin D predictors influence the change in vitamin D status from mid-pregnancy to birth .
-METHODS	Plasma 25-hydroxyvitamin D [ 25 ( OH ) D ] was determined at mid-pregnancy ( 8-20 weeks gestation ) and following birth ( n = 193 ) .
-METHODS	Usual predictors of vitamin D status [ body mass index ( BMI ) , race , season ] in addition to prenatal supplemental vitamin D intake and docosahexaenoic acid ( DHA ) status at delivery were assessed for their interaction on the change on plasma 25 ( OH ) D concentration between the two time points .
-RESULTS	Forty-nine percent of women had inadequate vitamin D status [ categorized as deficient ( < 30 nmol/L ) or insufficient ( 30-49 .9 nmol/L ) by IOM guidelines ] at mid-pregnancy and 82 % were deficient or insufficient at birth .
-RESULTS	Plasma 25 ( OH ) D concentration dropped 61 % from mid-pregnancy to birth .
-RESULTS	Season of birth ( F = 7.86 , P = 0.006 ) and mid-pregnancy plasma 25 ( OH ) D concentration ( F = 6.17 , P = 0.014 ) were significant variables in the change of vitamin D status while BMI , race , DHA status , and typical vitamin D intake ( 334 IU/day ) from prenatal supplements did not have an effect .
-RESULTS	Women who delivered in summer and fall had a 1.5-fold greater plasma 25 ( OH ) D concentration than women who delivered in winter in spring ( 41.1 23.1 and 40.7 20.5 nmol/L summer and fall , respectively , versus 27.7 17.9 and 29.3 21.4 nmol/L in winter and spring , respectively ) .
-CONCLUSIONS	Typical supplemental vitamin D intake during pregnancy did not prevent precipitous drops in maternal plasma 25 ( OH ) D concentration .
-CONCLUSIONS	Clinicians and dietitians should be aware of the risk of inadequate vitamin D status in pregnant women in the United States relative to their initial vitamin D status and the season of birth .
-
-###24284856
-BACKGROUND	Osteoarthritis is a common condition , typically treated with orally administered analgesics and non-steroidal anti-inflammatory drugs ( NSAIDs ) .
-BACKGROUND	Chronic administration of NSAIDs , serotonin-norepinephrine reuptake inhibitors ( SNRIs , i.e. , duloxetine ) , and opioid medications ( i.e. , tramadol ) is regularly associated with multiple , serious side effects , in part due to the route of administration .
-BACKGROUND	Transdermal delivery of NSAIDs , such as ibuprofen , represents a potentially alternative treatment for this inflammatory pain condition with a better therapeutic profile .
-OBJECTIVE	Investigate the safety and efficacy of a novel transdermal ibuprofen formulation ( VALE-ibuprofen ) containing 10 % ibuprofen , compared to a placebo in a randomized , double-blinded clinical trial , for clinical improvement in patients with moderate to severe painful osteoarthritis of the knee .
-METHODS	A randomized , placebo-controlled , double blind , multi-center Phase 2 clinical trial .
-METHODS	An academic medical center , and private rheumatology and interventional pain management practices .
-METHODS	The Phase 2 clinical study included patients with primary osteoarthritis in a single knee joint with a progression level of moderate to severe based in part on a grade II or III designation according to the Kellgren and Lawrence classification system .
-METHODS	Patients received the corresponding , randomly assigned study formulation ( VALE-ibuprofen or placebo ) for application to the target knee at a dose of 2.0 grams of drug product ( 200 mg ibuprofen ) twice daily for 14 days .
-METHODS	The evaluation of the efficacy of the treatments utilized the widely accepted methods of the Western Ontario and McMaster Universities ( WOMAC ) Osteoarthritis Index and the Visual Analog Scale ( VAS ) scores for the patients .
-RESULTS	The results indicate that the transdermal VALE-ibuprofen formulation was very well tolerated from a safety perspective during the 2-week trial and also produced significant , positive clinical improvements superior to the placebo in all clinical endpoints tested .
-RESULTS	In particular , the WOMACTotal and WOMACPhysical Functioning , for the VALE-ibuprofen , were superior compared to the placebo ( P = 0.0283 and P = 0.0201 , respectively ) .
-RESULTS	Other clinical endpoints including the WOMACPain , WOMACStiffness , and VASResting scores were superior to those obtained from the placebo group , trending towards statistical significance compared to placebo ( P = 0.0811 , 0.1103 , and 0.0785 , respectively ) .
-RESULTS	Based on the Patient and Physician Global Impression of Change survey , patient satisfaction slightly improved across both groups ; however , no statistical significance was detectable as compared to the baseline .
-CONCLUSIONS	The sample size of 64 subjects in the final data analysis and the lack of including an orally administered drug group are limitations of this study .
-CONCLUSIONS	The use of transdermal VALE-ibuprofen has beneficial clinical effects on the pain levels experienced in some patients with moderate to severe osteoarthritis of the knee as measured by the WOMAC Osteoarthritis Indices for stiffness , pain , physical function , and total .
-CONCLUSIONS	Visual Analog Scales ( VAS ) tests , VASMotion and VASWeight-bearing , again while appeared superior to placebo , were not statistically different from placebo .
-BACKGROUND	NCT01496326 .
-
-###24874481
-BACKGROUND	Invasion and metastasis remain a critical issue in cervical cancer .
-BACKGROUND	However , the underlying mechanism of it in cervical cancer remains unclear .
-BACKGROUND	The newly discovered protein , TBLR1 , plays a crucial role in regulating various key cellular functions .
-METHODS	In this study , western blot , real-time RT-PCR , immunohistochemical staining , 3D morphogenesis Matrigel culture , wound healing and Boyden chamber invasion assays , xenografted tumour model , luciferase assays , and chromatin immunoprecipitation assays were used .
-RESULTS	The expression of TBLR1 in cervical cancer cell lines and tissues was significantly upregulated at both the RNA and protein levels compared with that in normal cervical cells .
-RESULTS	Statistical analysis suggested that TBLR1 as an independent prognostic factor was significantly correlated with the clinical stage , survival time and recurrence .
-RESULTS	Moreover , overexpression of TBLR1 in Hela and Siha cell lines promoted invasion in vitro and in vivo with the increases of the mesenchymal factors vimentin and fibronectin and decreases of the epithelial marker - catenin .
-RESULTS	In contrast , RNAi-mediated knockdown of TBLR1 inhibited epithelial-mesenchymal transition in vitro and in vivo .
-RESULTS	Further study indicated that this might be mediated via the NF-B and Wnt / - Catenin signalling pathway , and involve regulation of Snail and Twist .
-CONCLUSIONS	The TBLR1 protein may be a prognostic marker in cervical cancer and play an important role in the invasion and metastasis of human cervical cancer .
-
-###26158926
-OBJECTIVE	To compare aqueous humor pH values in patients during femtosecond laser-assisted cataract surgery with patients during conventional phacoemulsification .
-METHODS	A prospective clinical study was conducted in 29 eyes of 29 patients who underwent cataract surgery by a single surgeon .
-METHODS	The femtosecond laser group included 15 eyes operated on with a femtosecond laser platform ( Catalys ; Abbott Medical Optics , Santa Ana , CA ) and the phacoemulsification group included 14 eyes that were operated on with conventional phacoemulsification .
-METHODS	The femtosecond laser group was subdivided into low , medium , and high level of cavitation gas bubbles after docking and the femtosecond laser procedure , according to the judgment of the surgeon .
-METHODS	Aqueous humor samples ( 0.10 to 0.15 mL ) were collected through a paracentesis from each patient after docking , corneal incisions , and nucleus fragmentation in the femtosecond laser group and after corneal incisions but before injection of viscoelastic in the phacoemulsification group , then analyzed with a pH meter .
-RESULTS	The mean pH was 6.53 0.09 ( range : 6.42 to 6.70 ) and 7.42 0.07 ( range : 7.28 to 7.48 ) in the femtosecond laser and phacoemulsification groups , respectively ( P < .001 ) .
-RESULTS	In the femtosecond laser group , no significant differences in pH were observed between the three subgroups after docking and the femtosecond laser surgical procedure : low ( 6.55 0.09 [ range : 6.53 to 6.57 ] ) , medium ( 6.54 0.07 [ range : 6.52 to 6.55 ] ) , and high ( 6.42 0.00 [ range : 6.40 to 6.44 ] ) level of gas bubbles .
-CONCLUSIONS	Cavitation bubbles derived from the photodisruption process in femtosecond laser-assisted cataract surgery lead to an acidic shift of the aqueous humor pH as a result of the transformation of carbon dioxide to carbonic acid .
-CONCLUSIONS	The level of gas bubbles visible after the laser photodisruption does not seem to correlate with this pH shift .
-CONCLUSIONS	Further analysis of femtosecond laser-assisted cataract surgery is necessary .
-
-###25398689
-BACKGROUND	Long-acting 2-adrenergic agonists ( LABAs ) are recommended in combination with inhaled corticosteroids ( ICSs ) for asthma management .
-BACKGROUND	Abediterol is a novel , selective , potent , once-daily LABA in development for treatment of asthma and chronic obstructive pulmonary disease .
-BACKGROUND	This study aimed to determine abediterol doses with similar peak bronchodilatory effect to salbutamol 400 g , and duration of action compatible with once-daily dosing in patients with persistent , stable asthma .
-METHODS	This was a Phase II , randomized , double-blind , double-dummy , crossover , placebo-controlled , dose-ranging study ( ClinicalTrials.gov NCT01425801 ) in 62 patients with mild-to-moderate asthma who were also receiving an ICS .
-METHODS	Patients received single doses of abediterol 0.313 , 0.625 , 1.25 , or 2.5 g , salbutamol 400 g , or placebo in the morning .
-METHODS	Spirometry was performed up to 36 h post-dose ; safety and tolerability were assessed throughout the study .
-METHODS	The primary endpoint was change from baseline in peak forced expiratory volume in 1 s ( FEV1 ) .
-METHODS	Additional endpoints included trough FEV1 , normalized area under the FEV1 curve ( FEV1 AUC ) up to 24 h post-dose , and peak and trough forced vital capacity ( FVC ) .
-RESULTS	Abediterol produced dose-dependent improvements in peak FEV1 from baseline compared with placebo , from 0.274 ( 95 % CI 0.221 , 0.327 ) to 0.405 L ( 95 % CI 0.353 , 0.458 ) for abediterol 0.313 to 2.5 g , respectively ( p < 0.0001 all doses ) .
-RESULTS	Abediterol 0.625 , 1.25 , and 2.5 g had similar magnitude of peak FEV1 effect to salbutamol .
-RESULTS	Dose-dependent changes from baseline in trough FEV1 versus placebo were 0.219 ( 95 % CI 0.136 , 0.302 ) to 0.400 L ( 95 % CI 0.317 , 0.483 ) for abediterol 0.313 to 2.5 g , respectively ( p < 0.0001 ) .
-RESULTS	All abediterol doses achieved significant improvements versus placebo in FEV1 AUC 0-6 , 0-12 , and 0-24 h , and peak and trough FVC ( p < 0.05 ) .
-RESULTS	Less than 10 % of patients experienced treatment-related adverse events for each dose of abediterol ; most were mild to moderate in intensity and the most common were headache and nasopharyngitis .
-RESULTS	There were no clinically relevant changes in heart rate .
-CONCLUSIONS	Abediterol 0.625-2 .5 g provided dose-dependent , clinically and statistically significant bronchodilation versus placebo in patients with asthma , with a peak effect similar to salbutamol and duration of action compatible with once-daily dosing .
-CONCLUSIONS	All doses of abediterol were well tolerated .
-
-###25512675
-OBJECTIVE	To identify the first time point of an MRI-verified response to certolizumab pegol ( CZP ) therapy in patients with rheumatoid arthritis ( RA ) .
-METHODS	Forty-one patients with active RA despite disease-modifying antirheumatic drug therapy were randomised 2:1 to CZP ( CZP loading dose 400mg every 2weeksat weeks 0-4 ; CZP 200mg every 2weeksat weeks 6-16 ) or placeboCZP ( placebo at weeks 0-2 ; CZP loading dose at weeks 2-6 ; CZP 200mg every 2weeks at weeks 8-16 ) .
-METHODS	Contrast-enhanced MRI of one hand and wrist was acquired at baseline ( week 0 ) and weeks 1 , 2 , 4 , 8 and 16 .
-METHODS	All six time points were read simultaneously , blinded to time , using the Outcome Measures in Rheumatology Clinical Trials RA MRI scoring system .
-METHODS	Primary outcome was change in synovitis score in the CZP group ; secondary outcomes were change in bone oedema ( osteitis ) and erosion scores and clinical outcome measures .
-RESULTS	Forty patients were treated ( 27 CZP , 13 placeboCZP ) , and 36 ( 24 CZP , 12 placeboCZP ) completed week 16 .
-RESULTS	In the CZP group , there were significant reductions from baseline synovitis ( Hodges-Lehmann estimate of median change , -1.5 , p = 0.049 ) and osteitis scores ( -2.5 , p = 0.031 ) at week 16 .
-RESULTS	Numerical , but statistically insignificant , MRI inflammation reductions were observed at weeks 1-2 in the CZP group .
-RESULTS	No significant change was seen in bone erosion score .
-RESULTS	Improvements across all clinical outcomes were seen in the CZP group .
-CONCLUSIONS	CZP reduced MRI synovitis and osteitis scores at week 16 , despite small sample size and the technical challenge of reading six time points simultaneously .
-CONCLUSIONS	This study provides essential information on optimal MRI timing for subsequent trials .
-BACKGROUND	ClinicalTrials.gov , NCT01235598 .
-
-###24780501
-OBJECTIVE	High-density lipoproteins ( HDLs ) have several potentially protective vascular effects .
-OBJECTIVE	Most clinical studies of therapies targeting HDL have failed to show benefits vs. placebo .
-OBJECTIVE	To investigate the effects of an HDL-mimetic agent on atherosclerosis by intravascular ultrasonography ( IVUS ) and quantitative coronary angiography ( QCA ) .
-METHODS	A prospective , double-blinded , randomized trial was conducted at 51 centres in the USA , the Netherlands , Canada , and France .
-METHODS	Intravascular ultrasonography and QCA were performed to assess coronary atherosclerosis at baseline and 3 ( 2-5 ) weeks after the last study infusion .
-METHODS	Five hundred and seven patients were randomized ; 417 and 461 had paired IVUS and QCA measurements , respectively .
-METHODS	Patients were randomized to receive 6 weekly infusions of placebo , 3 mg/kg , 6 mg/kg , or 12 mg/kg CER-001 .
-METHODS	The primary efficacy parameter was the nominal change in the total atheroma volume .
-METHODS	Nominal changes in per cent atheroma volume on IVUS and coronary scores on QCA were also pre-specified endpoints .
-RESULTS	The nominal change in the total atheroma volume ( adjusted means ) was -2.71 , -3.13 , -1.50 , and -3.05 mm ( 3 ) with placebo , CER-001 3 mg/kg , 6 mg/kg , and 12 mg/kg , respectively ( primary analysis of 12 mg/kg vs. placebo : P = 0.81 ) .
-RESULTS	There was also no difference among groups for the nominal change in per cent atheroma volume ( 0.02 , -0.02 , 0.01 , and 0.19 % ; nominal P = 0.53 for 12 mg/kg vs. placebo ) .
-RESULTS	Change in the coronary artery score was -0.022 , -0.036 , -0.022 , and -0.015 mm ( nominal P = 0.25 , 0.99 , 0.55 ) , and change in the cumulative coronary stenosis score was -0.51 , 2.65 , 0.71 , and -0.77 % ( compared with placebo , nominal P = 0.85 for 12 mg/kg and nominal P = 0.01 for 3 mg/kg ) .
-RESULTS	The number of patients with major cardiovascular events was 10 ( 8.3 % ) , 16 ( 13.3 % ) , 17 ( 13.7 % ) , and 12 ( 9.8 % ) in the four groups .
-CONCLUSIONS	CER-001 infusions did not reduce coronary atherosclerosis on IVUS and QCA when compared with placebo .
-CONCLUSIONS	Whether CER-001 administered in other regimens or to other populations could favourably affect atherosclerosis must await further study .
-CONCLUSIONS	Name of the trial registry : Clinicaltrials.gov ; Registry 's URL : http://clinicaltrials.gov/ct2/show/NCT01201837?term=cer-001&rank=2;
-BACKGROUND	NCT01201837 .
-
-###25675560
-OBJECTIVE	To observe the effects of electroacupuncture at Neiguan ( PC 6 ) and Jianshi ( PC 5 ) com - bined with granisetron on nausea and vomiting as well as serum levels of 5-hydroxy tryptamine ( 5-HT ) and dopamine ( DA ) in chemotherapy patients .
-METHODS	Seventy-two chemotherapy patients who met the inclusive criteria were randomly divided into an observation group ( 38 cases ) and a control group ( 34 cases ) .
-METHODS	The patients in the observation group were treated with electroacupuncture at Neiguan ( PC 6 ) and Jianshi ( PC 5 ) combined with granisetron injection ; the patients in the control group were treated with electroacupuncture at sham-point 1 and sham - point 2 , and the rest treatment was identical to the observation group .
-METHODS	After 3-day treatment , the clinical indices including times of vomiting and severity of nausea , etc. were observed in the two groups .
-RESULTS	( 1 ) At the acute stage within 24 h , the times of vomiting in the two groups were not significantly different ( P > 0.05 ) ; at the delay stage , the severity of nausea was significantly higher in the control group ( P < 0.05 ) .
-RESULTS	( 2 ) As for the comprehensive efficacy and rate of complete control , there was no obvious difference between the two groups at the acute stage ( P > 0.05 ) ; while in the delay stage , the rate of complete control in the observation group was superior to that in the control group ( P < 0.01 ) .
-RESULTS	( 3 ) Compared before and after the treatment , serum levels of 5-HT and DA were evidently reduced in the observation group ( both P < 0.05 ) , while those in the control group were not significantly changed after treatment ( both P > 0.05 ) .
-CONCLUSIONS	Electroacupuncture at Neiguan ( PC 6 ) and Jianshi ( PC 5 ) combined with granisetron could obviously relieve the nausea in chemotherapy patients at the delay stage .
-CONCLUSIONS	The effect mechanism is possibly related to reducing the content of 5-HIT nndl nA
-
-###26349127
-OBJECTIVE	The purpose of this study was to compare the reduction of the clinical signs of inflammation by two power interdental cleaning devices combined with a manual toothbrush .
-METHODS	Sixty-nine subjects completed this randomized , four-week , single-blind , two-group , parallel clinical study .
-METHODS	Subjects were randomly assigned to one of two treatment groups : Waterpik Water Flosser ( WF ) plus a manual toothbrush ; or Sonicare Air Floss Pro ( AFP ) plus a manual toothbrush .
-METHODS	All subjects received both written and verbal instructions and demonstrated proficiency prior to starting the study .
-METHODS	Instructions were reviewed at the two-week visit ( W2 ) .
-METHODS	Data were evaluated for whole mouth , lingual , and facial areas for bleeding on probing ( BOP ) and Modified Gingival Index ( MGI ) .
-METHODS	Plaque data were recorded for whole mouth , lingual , facial , approximal , and marginal areas of the tooth using the Rustogi Modification of the Navy Plaque Index ( RMNPI ) .
-METHODS	BOP , MGI , and RMNPI were scored at baseline ( BSL ) , two weeks , and four weeks ( W4 ) .
-RESULTS	Both groups showed significant reductions in BOP and MGI from baseline for all regions and time points measured ( p < 0.001 ) .
-RESULTS	Both groups showed significant reductions from baseline for all areas at W4 for RMNPI ( p < 0.001 ) .
-RESULTS	The WF group was significantly more effective than the AFP group at reducing bleeding and gingivitis for all areas measured at all time points .
-RESULTS	At W4 , the WF group was 54 % more effective for bleeding and 32 % for gingivitis ( p < 0.001 ) .
-RESULTS	Plaque accumulation was significantly less at W4 for the WF group compared to the AFP group ( 28 % , p 0.017 ) .
-CONCLUSIONS	The Waterpik Water Flosser is significantly more effective than the Sonicare Air Floss Pro for reducing clinical signs of inflammation .
-
-###25579777
-BACKGROUND	Streptococcus pneumoniae infections have periodically caused significant morbidity and outbreaks among military personnel , especially trainees .
-BACKGROUND	This study evaluated the effectiveness of the 23-valent polysaccharide pneumococcal vaccine ( PPV23 ) in reducing pneumonia in healthy military trainees .
-METHODS	From 2000-2003 , 152723 military trainees from 5 US training camps were enrolled in a double-blind , placebo-controlled trial of PPV23 .
-METHODS	Participants were closely monitored during basic training for radiographically confirmed pneumonia etiology and loss-of-training days .
-METHODS	Participants were also followed using electronic medical encounter data until 1 June 2007 for three additional outcomes : any-cause pneumonia , any acute respiratory disease , and meningitis .
-RESULTS	Comparison of demographic data by study arm suggested the randomization procedures were sound .
-RESULTS	During basic training , 371 study participants developed radiographically confirmed pneumonia .
-RESULTS	None had evidence of S. pneumoniae infection , but other etiologies included adenovirus ( 38 % ) , Chlamydophila pneumoniae ( 9 % ) , and Mycoplasma pneumoniae ( 8 % ) .
-RESULTS	During the follow-up period , many study participants , in both the vaccine and placebo groups , had clinical encounters for the medical outcomes of interest .
-RESULTS	However , Cox 's proportional hazard modeling revealed no evidence of a protective vaccine effect during recruit training ( radiographically confirmed pneumonia ) or up to 6.7 years after enrollment ( any-cause pneumonia , any acute respiratory disease , or meningitis ) .
-CONCLUSIONS	Data from this large , double-blind , placebo controlled trial do not support routine use of PPV23 among healthy new military trainees .
-CONCLUSIONS	This clinical trial was registered at clinicaltrials.gov ( registration number NCT02079701 , http://www.clinicaltrials.gov/ct2/show/NCT02079701?term=NCT02079701&rank=1 ) .
-
-###24689093
-OBJECTIVE	Both unsedated transoral endoscopy ( TOE ) and sedated TOE have some drawbacks in clinical practice .
-OBJECTIVE	Unsedated transnasal endoscopy ( TNE ) has been suggested as an alternative to both methods .
-OBJECTIVE	This study aimed to determine the advantages of TNE in patients who have previously undergone unsedated conventional TOE .
-METHODS	Patients who had received an unsedated TOE in the last 12 months and were scheduled for a second upper endoscopy were included .
-METHODS	They were randomized to undergo either unsedated TOE , using a standard endoscope , or unsedated TNE , using an ultrathin endoscope .
-METHODS	Post-procedure , patients were asked to complete a questionnaire to assess pain , discomfort and acceptability of the procedure , and to compare the current procedure with their previous unsedated TOE .
-METHODS	Endoscope insertion rate , procedure duration , and side-effects were recorded .
-RESULTS	Each group included 50 patients .
-RESULTS	With the exception of nasal pain , the tolerability and acceptance were significantly greater in the unsedated TNE group .
-RESULTS	Significantly more TNE patients ( 82 % ) found the current endoscopic procedure to be better than their previous TOE when compared with patients who had received a second TOE ( 12 % ) .
-RESULTS	A repeat procedure was significantly more acceptable for TNE patients when compared to the TOE group ( 68 % vs. 16 % ) .
-RESULTS	The duration of endoscopy was significantly shorter in TOE than in TNE ( p < 0.05 ) .
-RESULTS	Endoscope insertion failed in 4 % and mild epistaxis was observed in 4 % of TNE patients .
-CONCLUSIONS	Unsedated TNE was better tolerated in endoscopy experienced patients when compared with unsedated TOE .
-CONCLUSIONS	The majority of patients found TNE more acceptable and preferable to TOE , suggesting that TNE should become a more common practice in clinics when applicable .
-
-###25301463
-BACKGROUND	Little is known about mode of death after acute heart failure ( AHF ) hospitalization .
-BACKGROUND	In the RELAX-AHF ( Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure ) study , serelaxin , the recombinant form of human relaxin-2 , reduced post-discharge mortality at 180 days in selected patients with AHF .
-OBJECTIVE	The goal of this study was to assess the effect of serelaxin on specific modes of death in patients with AHF .
-METHODS	The RELAX-AHF study randomized 1,161 patients with AHF to 48 h of therapy with intravenous serelaxin or placebo .
-METHODS	Patients were followed for vital status through 180 days .
-METHODS	A blinded clinical events committee reviewed all deaths and adjudicated a cause of death on the basis of pre-specified criteria .
-METHODS	Cox proportional hazard models were used to assess the effect of serelaxin on each mode of death , on the basis of pre-specified groupings of mode of death .
-RESULTS	There were 107 deaths ( 9.3 % ) : 37 ( 35 % ) due to HF , 25 ( 23 % ) due to sudden death , 15 ( 14 % ) due to other cardiovascular ( CV ) causes , 19 ( 18 % ) due to non-CV causes , and 11 ( 10 % ) classified as unknown .
-RESULTS	The treatment effect of serelaxin was most pronounced on other CV deaths ( hazard ratio [ HR ] : 0.29 ; 95 % CI : 0.12 to 0.73 ; p = 0.005 ) and sudden death ( HR : 0.46 ; 95 % CI : 0.20 to 1.07 ; p = 0.065 ) .
-RESULTS	There was no apparent impact of serelaxin treatment on HF deaths or non-CV deaths .
-CONCLUSIONS	In the RELAX-AHF study , the effects of serelaxin on mortality were primarily driven by reduction in mortality from other CV causes and sudden death , without apparent impact on HF deaths .
-CONCLUSIONS	( Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure [ RELAX-AHF ] ; NCT00520806 ) .
-
-###24837512
-OBJECTIVE	Aerosol immunization may be a useful tool to reach and sustain the elimination of measles , rubella , and congenital rubella syndrome .
-OBJECTIVE	We compared booster seroresponses to aerosolized or injected MMR vaccines containing different strains of measles ( Attenuvax or Edmonston-Zagreb ) and mumps ( Jeryl-Lynn or Leningrad-Zagreb ) .
-OBJECTIVE	To assess the safety and immunogenicity of two MMR : Vaccines administered by aerosol .
-METHODS	A randomized and controlled clinical trial was conducted to evaluate the safety and booster responses to the MMR SII ( Serum Institute of India ) and MMR II ( Merck Sharp & Dhome ) vaccines , both of which were administered by aerosol ( ae ) or injection ( inj ) to Mexican children aged 6-7 years in elementary schools .
-METHODS	The seroresponses were evaluated by PRN ( measles ) and ELISA ( rubella and mumps ) .
-METHODS	Adverse events were followed-up for 28 days after the immunization .
-RESULTS	Two hundred and fifty-three of 260 children completed the one-month follow-up .
-RESULTS	All participants reached protective seropositivity for measles and rubella after immunization , and 98.3 to 100 % reached protective seropositivity for mumps ( p = 0.552 ) .
-RESULTS	The proportions of the seroresponses ( a 2-fold rise from the baseline antibody titers ) to measles were 38.3 % for MMR SII ( ae ) , 31.3 % for MMR II ( ae ) , 37.5 % for MMR SII ( inj ) , and 44.6 % for MMR II ( inj ) ( p = 0.483 ) .
-RESULTS	The seroresponses for rubella were 26.7 % for MMR SII ( ae ) , 31.3 % for MMR II ( ae ) , 46.9 % for MMR SII ( inj ) , and 40.0 % for MMR II ( inj ) ( p = 0.086 ) .
-RESULTS	The seroresponse to mumps were 31.7 % for MMR SII ( ae ) , 25.0 % for MMR II ( ae ) , 48.4 % for MMR SII ( inj ) , and 53.9 % for MMR II ( inj ) ( p = 0.002 ) .
-RESULTS	The difference in the seroresponse of a 4-fold rise from the baseline antibody titers was not statistically significant .
-RESULTS	Only mild adverse events were noted .
-CONCLUSIONS	Aerosolized vaccines were as safe and as immunogenic as injected vaccines .
-BACKGROUND	CMN 2010-005 ( National Regulatory Authority ) .
-
-###25316259
-BACKGROUND	We evaluated the efficacy and safety of S-1 plus oxaliplatin ( SOX ) as an alternative to cisplatin plus S-1 ( CS ) in first-line chemotherapy for advanced gastric cancer ( AGC ) .
-METHODS	In this randomized , open-label , multicenter phase III study , patients were randomly assigned to receive SOX ( 80-120 mg/day S-1 for 2 weeks with 100 mg/m ( 2 ) oxaliplatin on day 1 , every 3 weeks ) or CS ( S-1 for 3 weeks with 60 mg/m ( 2 ) cisplatin on day 8 , every 5 weeks ) .
-METHODS	The primary end points were noninferiority in progression-free survival ( PFS ) and relative efficacy in overall survival ( OS ) for SOX using adjusted hazard ratios ( HRs ) with stratification factors ; performance status and unresectable or recurrent ( + adjuvant chemotherapy ) disease .
-RESULTS	Overall , 685 patients were randomized from January 2010 to October 2011 .
-RESULTS	In per-protocol population , SOX ( n = 318 ) was noninferior to CS ( n = 324 ) in PFS [ median , 5.5 versus 5.4 months ; HR 1.004 , 95 % confidence interval ( CI ) 0.840-1 .199 ; predefined noninferiority margin 1.30 ] .
-RESULTS	The median OS for SOX and CS were 14.1 and 13.1 months , respectively ( HR 0.958 with 95 % CI 0.803-1 .142 ) .
-RESULTS	In the intention-to-treat population ( SOX , n = 339 ; CS , n = 337 ) , the HRs in PFS and OS were 0.979 ( 95 % CI 0.821-1 .167 ) and 0.934 ( 95 % CI 0.786-1 .108 ) , respectively .
-RESULTS	The most common grade 3 adverse events ( SOX versus CS ) were neutropenia ( 19.5 % versus 41.8 % ) , anemia ( 15.1 % versus 32.5 % ) , hyponatremia ( 4.4 % versus 13.4 % ) , febrile neutropenia ( 0.9 % versus 6.9 % ) , and sensory neuropathy ( 4.7 % versus 0 % ) .
-CONCLUSIONS	SOX is as effective as CS for AGC with favorable safety profile , therefore SOX can replace CS .
-BACKGROUND	JapicCTI-101021 .
-
-###24585502
-OBJECTIVE	To assess the differences in clinical outcome between complex patients treated with Resolute zotarolimus-eluting stents ( ZES ) versus Xience V everolimus-eluting stents ( EES ) .
-BACKGROUND	Nowadays , many complex patients with coronary disease are treated with percutaneous coronary interventions , using drug-eluting stents ( DES ) .
-METHODS	We analyzed 2-year outcome data of 1,033 complex patients of the TWENTE trial , treated with second-generation Resolute ZES or Xience V EES .
-METHODS	Complex patients had at least one of the following characteristics : renal insufficiency ( creatinine140 mol/l ) ; ejection fraction < 30 % ; acute myocardial infarction ( MI ) within previous 72 hrs ; > 1 lesion/vessel ; > 2 vessels treated ; lesion length > 27 mm ; bifurcation ; saphenous vein graft lesion ; arterial bypass graft lesion ; in-stent restenosis ; unprotected left main lesion ; lesion with thrombus ; or lesion with total occlusion .
-METHODS	Target vessel failure ( TVF ) , the primary composite endpoint of the trial , was defined as cardiac death , target vessel-related MI , or target vessel revascularization .
-RESULTS	Among the 1,033 complex patients , 529 ( 51 % ) were treated with Resolute ZES and 504 ( 49 % ) with Xience V EES .
-RESULTS	Patient - and procedure-related characteristics were similar between DES groups .
-RESULTS	After 2-year follow-up , outcome was also similar between DES groups .
-RESULTS	TVF occurred in 12.1 % of patients treated with Resolute ZES and 12.3 % of patients treated with Xience V EES .
-RESULTS	In addition , DES groups did not differ significantly in cardiac death , MI , or target vessel revascularization-the individual components of TVF .
-CONCLUSIONS	Complex patients treated with Resolute ZES and Xience V EES showed similar safety and efficacy during 2-year follow-up .
-CONCLUSIONS	2014 Wiley Periodicals , Inc. .
-
-###25222001
-OBJECTIVE	The aim of this study was to compare the use of multilayer amniotic membrane transplantation ( AMT ) with lamellar corneal transplantation ( LCT ) and lamellar scleral transplantation ( LST ) for the treatment of scleral thinning after pterygium surgery associated with beta therapy .
-METHODS	Twenty-six eyes from 26 different patients with scleral thinning as a consequence of beta therapy after pterygium surgery were evaluated at the Federal University of So Paulo , Brazil .
-METHODS	Ophthalmologic examination and ultrasound biomicroscopy were performed to assess scleral thinning before the transplant surgery and then repeated at 30 , 90 , and 180 days after surgery .
-METHODS	An increase in scleral thickness , epithelialization of the ocular surface , and preservation of the ocular globe were the main outcome measures .
-RESULTS	Irrespective of the surgical technique used ( AMT , LCT , or LST ) , no clinical or statistical changes in corrected distance visual acuity were found in any of the patients during this study .
-RESULTS	The median preoperative scleral thickness was similar in all 3 groups : AMT = 0.45 mm , LST = 0.48 mm , and LCT = 0.52 mm ( P = 0.257 ) ; however , 6 months after surgery , the median thickness in the AMT group ( 0.19 ) was significantly less than that of the LCT group ( 0.57 ) ( P = 0.27 ) or the LST group ( 0.76 ) ( P = 0.19 ) .
-RESULTS	Epithelialization occurred in all the patients .
-CONCLUSIONS	LCT was the best option for the structural treatment of scleral thinning , followed by LST with a conjunctival flap .
-CONCLUSIONS	A high rate of reabsorption was found with AMT , which was the least effective of the 3 therapeutic options and should not be used for this condition .
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-###24752193
-BACKGROUND	Agility is a determinant component in soccer performance .
-BACKGROUND	This study aimed to evaluate the reliability and sensitivity of a `` Modified Illinois change of direction test '' ( MICODT ) in ninety-five U-14 soccer players .
-METHODS	A total of 95 U-14 soccer players ( mean SD : age : 13.61 1.04 years ; body mass : 30.52 4.54 kg ; height : 1.57 0.1 m ) from a professional and semi-professional soccer academy , participated to this study .
-METHODS	Sixty of them took part in reliability analysis and thirty-two in sensitivity analysis .
-RESULTS	The intraclass correlation coefficient ( ICC ) that aims to assess relative reliability of the MICODT was of 0.99 , and its standard error of measurement ( SEM ) for absolute reliability was < 5 % ( 1.24 % ) .
-RESULTS	The MICODT 's capacity to detect change is `` good '' , it 's SEM ( 0.10 s ) was SWC ( 0.33 s ) .
-RESULTS	The MICODT is significantly correlated to the Illinois change of direction speed test ( ICODT ) ( r = 0.77 ; p < 0.0001 ) .
-RESULTS	The ICODT 's MDC95 ( 0.64 s ) was twice about the MICODT 's MDC95 ( 0.28 s ) , indicating that MICODT presents better ability to detect true changes than ICODT .
-RESULTS	The MICODT provided good sensitivity since elite U-14 soccer players were better than non-elite one on MICODT ( p = 0.005 ; dz = 1.01 [ large ] ) .
-RESULTS	This was supported by an area under the ROC curve of 0.77 ( CI 95 % , 0.59 to 0.89 , p < 0.0008 ) .
-RESULTS	The difference observed in these two groups in ICODT was not statistically significant ( p = 0.14 ; dz = 0.51 [ small ] ) , showing poor discriminant ability .
-CONCLUSIONS	MICODT can be considered as more suitable protocol for assessing agility performance level than ICODT in U-14 soccer players .
-
-###25127655
-BACKGROUND	Perioperative management with reduced-dose warfarin is of potential interest by eliminating the need for bridging while still maintaining a degree of anticoagulation .
-BACKGROUND	The outcomes of this regimen have not been well determined .
-METHODS	In a randomized controlled trial we compared two regimens for management of anticoagulation with warfarin in patients with implantation of a pacemaker or defibrillator .
-METHODS	Half dose of warfarin for 3-6 days , depending on the baseline international normalized ratio ( INR ) , before surgery aiming at an INR of 1.7 was compared with interrupted warfarin for 5 days with preoperative bridging with low-molecular-weight heparin ( LMWH ) at therapeutic dose for 2.5 days .
-METHODS	Main safety outcome was pocket hematoma .
-METHODS	Secondary outcomes were major bleeding , thromboembolism - all within 1 month , days of hospitalization and number of patients requiring correction of INR with vitamin K.
-RESULTS	The study was planned for 450 patients but it was discontinued prematurely due to a change in practice .
-RESULTS	Pocket hematoma occurred in 4 of 85 patients ( 5 % ) randomized to the bridged regimen and in 3 of 86 patients ( 3 % ) randomized to reduced-dose warfarin .
-RESULTS	One pocket hematoma in each group was severe .
-RESULTS	There were no major hemorrhages or thromboembolism within the 1-month window .
-RESULTS	Duration of hospitalization was similar in the two groups .
-RESULTS	Correction of INR the day before surgery with vitamin K had to be used for significantly more patients in the reduced-dose warfarin group ( 41 % ) than in the bridged regimen group ( 6 % ) .
-CONCLUSIONS	The reduced-dose warfarin regimen appeared to have similar safety after device implantation as interrupted warfarin with preoperative LMWH bridging .
-CONCLUSIONS	Due to premature discontinuation no firm conclusion can be drawn .
-CONCLUSIONS	The reduced-dose warfarin regimen often failed to achieve the intended preoperative INR .
-CONCLUSIONS	ClinicalTrials.gov Identifier : NCT 02094157 .
-
-###24744200
-OBJECTIVE	This study introduces a method to calculate myocardium blood flow ( MBF ) and coronary flow reserve ( CFR ) using the relatively low-dose dynamic 320-row multi-detector computed tomography ( MDCT ) , validates the method against ( 15 ) O-HO positron-emission tomography ( PET ) and assesses the CFRs of coronary artery disease ( CAD ) patients .
-METHODS	Thirty-two subjects underwent both dynamic CT perfusion ( CTP ) and PET perfusion imaging at rest and during pharmacological stress .
-METHODS	In 12 normal subjects ( pilot group ) , the calculation method for MBF and CFR was established .
-METHODS	In the other 13 normal subjects ( validation group ) , MBF and CFR obtained by dynamic CTP and PET were compared .
-METHODS	Finally , the CFRs obtained by dynamic CTP and PET were compared between the validation group and CAD patients ( n = 7 ) .
-RESULTS	Correlation between MBF of MDCT and PET was strong ( r = 0.95 , P < 0.0001 ) .
-RESULTS	CFR showed good correlation between dynamic CTP and PET ( r = 0.67 , P = 0.0126 ) .
-RESULTS	CFRCT in the CAD group ( 2.30.8 ) was significantly lower than that in the validation group ( 5.21.8 ) ( P = 0.0011 ) .
-CONCLUSIONS	We established a method for measuring MBF and CFR with the relatively low-dose dynamic MDCT .
-CONCLUSIONS	Lower CFR was well demonstrated in CAD patients by dynamic CTP .
-CONCLUSIONS	MBF and CFR can be calculated using dynamic CTP with 320-row MDCT .
-CONCLUSIONS	MBF and CFR showed good correlation between dynamic CTP and PET .
-CONCLUSIONS	Lower CFR was well demonstrated in CAD patients by dynamic CTP .
-
-###25124510
-BACKGROUND	The presence of depressive subsyndromal symptoms ( SS ) in bipolar disorder ( BD ) increases the risk of affective relapse and worsens social , cognitive functioning , and quality of life .
-BACKGROUND	Nonetheless , there are limited data on how to optimize the treatment of subthreshold depressive symptoms in BD .
-BACKGROUND	Mindfulness-Based Cognitive Therapy ( MBCT ) is a psychotherapeutic intervention that has been shown effective in unipolar depression .
-BACKGROUND	The assessment of its clinical effectiveness and its impact on biomarkers in bipolar disorder patients with subsyndromal depressive symptoms and psychopharmacological treatment is needed .
-METHODS	A randomized , multicenter , prospective , versus active comparator , evaluator-blinded clinical trial is proposed .
-METHODS	Patients with BD and subclinical or mild depressive symptoms will be randomly allocated to : 1 ) MBCT added to psychopharmacological treatment ; 2 ) a brief structured group psychoeducational intervention added to psychopharmacological treatment ; 3 ) standard clinical management , including psychopharmacological treatment .
-METHODS	Assessments will be conducted at screening , baseline , post-intervention ( 8 weeks ) and 4 month follow-up post-intervention .
-METHODS	The aim is to compare MBCT intervention versus a brief structured group psychoeducation .
-METHODS	Our hypothesis is that MBCT will be more effective in reducing the subsyndromal depressive symptoms and will improve cognitive performance to a higher degree than the psychoeducational treatment .
-METHODS	It is also hypothesized that a significant increase of BDNF levels will be found after the MBCT intervention .
-CONCLUSIONS	This is the first randomized controlled trial to evaluate the effects of MBCT compared to an active control group on depressive subthreshold depressive symptoms in patients with bipolar disorder .
-BACKGROUND	ClinicalTrials.gov : NCT02133170 .
-BACKGROUND	Registered 04/30/2014 .
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-###24995901
-BACKGROUND	Residual inhibition ( RI ) is the temporary inhibition of tinnitus by use of masking stimuli when the device is turned off .
-OBJECTIVE	The main aim of this study was to evaluate the effects of RI induced by auditory electrical stimulation ( AES ) in the primary auditory pathways using early auditory-evoked potentials ( AEPs ) in subjective idiopathic tinnitus ( SIT ) subjects .
-METHODS	A randomized placebo-controlled study was conducted on forty-four tinnitus subjects .
-METHODS	All enrolled subjects based on the responses to AES , were divided into two groups of RI and Non-RI ( NRI ) .
-METHODS	The results of the electrocochleography ( ECochG ) , auditory brain stem response ( ABR ) and brain stem transmission time ( BTT ) were determined and compared pre - and post-AES in the studied groups .
-RESULTS	The mean differences in the compound action potential ( CAP ) amplitudes and III/V and I/V amplitude ratios were significantly different between the RI , NRI and PES controls .
-RESULTS	BTT was significantly decreased associated with RI .
-CONCLUSIONS	The observed changes in AEP associated with RI suggested some peripheral and central auditory alterations .
-CONCLUSIONS	Synchronized discharges of the auditory nerve fibers and inhibition of the abnormal activity of the cochlear nerve by AES may play important roles associated with RI .
-CONCLUSIONS	Further comprehensive studies are required to determine the mechanisms of RI more precisely .
-
-###25169073
-BACKGROUND	In sub-Saharan Africa , malaria continues to cause over 10,000 maternal deaths and 75,000 to 200,000 infant deaths .
-BACKGROUND	Successful control of malaria in pregnancy could save lives of mothers and babies and is an essential part of antenatal care in endemic areas .
-BACKGROUND	The primary objective is to determine the protective efficacy of community-scheduled screening and treatment ( CSST ) using community health workers ( CHW ) against the primary outcome of prevalence of placental malaria .
-BACKGROUND	The secondary objectives are to determine the protective efficacy of CSST on maternal anaemia , maternal peripheral infection , low birth weight , selection of sulfadoxine-pyrimethamine ( SP ) resistance markers , and on antenatal clinic ( ANC ) attendance and coverage of intermittent preventive treatment during pregnancy ( IPTp-SP ) .
-METHODS	This is a multi-centre cluster-randomised controlled trial involving three countries with varying malaria endemicity ; low ( The Gambia ) versus high transmission ( Burkina Faso and Benin ) , and varying degrees of SP resistance ( high in Benin and moderate in Gambia and Burkina Faso ) .
-METHODS	CHW and their related catchment population who are randomised into the intervention arm will receive specific training on community-based case management of malaria in pregnancy .
-METHODS	All women in both study arms will be enrolled at their first ANC visits in their second trimester where they will receive their first dose of IPTp-SP .
-METHODS	Thereafter , CHW in the intervention arm will perform scheduled monthly screening and treatment in the womens homes .
-METHODS	At time of delivery , a placental biopsy will be collected from all women to determine placental malaria .
-METHODS	At each contact point , filter paper and blood slides will be collected for detection of malaria infection and SP resistance markers .
-CONCLUSIONS	To reach successful global malaria control , there is an urgent need to access those at greatest risk of malaria infection .
-CONCLUSIONS	The project is designed to develop a low-cost intervention in pregnant women which will have an immediate impact on the malaria burden in resource-limited countries .
-CONCLUSIONS	This will be done by adding to the standard IPTp-SP delivered through the health facilities : an `` extension '' strategy to the communities in rural areas thus bringing health services closer to where women live .
-BACKGROUND	Current Controlled Trials : ISRCTN37259296 ( 5 July 2013 ) , and clinicaltrials.gov : NCT01941264 ( 10 September 2013 ) .
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-###24587337
-OBJECTIVE	We studied the combined effects of wholegrain , fish and bilberries on serum metabolic profile and lipid transfer protein activities in subjects with the metabolic syndrome .
-METHODS	Altogether 131 subjects ( 40-70 y , BMI 26-39 kg/m ( 2 ) ) with impaired glucose metabolism and features of the metabolic syndrome were randomized into three groups with 12-week periods according to a parallel study design .
-METHODS	They consumed either : a ) wholegrain and low postprandial insulin response grain products , fatty fish 3 times a week , and bilberries 3 portions per day ( HealthyDiet ) , b ) wholegrain and low postprandial insulin response grain products ( WGED ) , or c ) refined wheat breads as cereal products ( Control ) .
-METHODS	Altogether 106 subjects completed the study .
-METHODS	Serum metabolic profile was studied using an NMR-based platform providing information on lipoprotein subclasses and lipids as well as low-molecular-weight metabolites .
-RESULTS	There were no significant differences in clinical characteristics between the groups at baseline or at the end of the intervention .
-RESULTS	Mixed model analyses revealed significant changes in lipid metabolites in the HealthyDiet group during the intervention compared to the Control group .
-RESULTS	All changes reflected increased polyunsaturation in plasma fatty acids , especially in n-3 PUFAs , while n-6 and n-7 fatty acids decreased .
-RESULTS	According to tertiles of changes in fish intake , a greater increase of fish intake was associated with increased concentration of large HDL particles , larger average diameter of HDL particles , and increased concentrations of large HDL lipid components , even though total levels of HDL cholesterol remained stable .
-CONCLUSIONS	The results suggest that consumption of diet rich in whole grain , bilberries and especially fatty fish causes changes in HDL particles shifting their subclass distribution toward larger particles .
-CONCLUSIONS	These changes may be related to known protective functions of HDL such as reverse cholesterol transport and could partly explain the known protective effects of fish consumption against atherosclerosis .
-BACKGROUND	The study was registered at ClinicalTrials.gov NCT00573781 .
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-###25496303
-BACKGROUND	Ciclosporin is approved for the treatment of atopic dermatitis ( AD ) in dogs and has been shown to be safe and effective .
-BACKGROUND	Placebo-controlled studies suggest that oclacitinib is a safe and effective alternative therapy .
-OBJECTIVE	To evaluate the efficacy and safety of oclacitinib , in comparison to ciclosporin , for the control of AD in a blinded , randomized clinical trial , incorporating a noninferiority test at day 28 .
-METHODS	A total of 226 client-owned dogs with a history of AD from eight sites were enrolled .
-METHODS	Enrolled animals were randomized to receive oral oclacitinib ( 0.4-0 .6 mg/kg twice daily for 14 days , then once daily ) or oral ciclosporin ( 3.2-6 .6 mg/kg once daily ) for 12 weeks .
-METHODS	Owners assessed pruritus using an enhanced visual analog scale ( VAS ) , and veterinarians assessed dermatitis using the Canine Atopic Dermatitis Extent and Severity Index ( CADESI ) -02 .
-RESULTS	On days 1 , 2 , 7 , 14 , 28 , 56 and 84 , the percentage reduction from baseline for owner-assessed pruritus changed from 25.6 to 61.0 % in the oclacitinib group compared with 6.5 to 61.5 % in the ciclosporin group ; differences were significant at all time points up to day 28 .
-RESULTS	On day 56 , ciclosporin-treated dogs showed a similar decrease in pruritus to oclacitinib-treated dogs .
-RESULTS	On day 14 , the percentage reduction from baseline CADESI-02 was significantly greater in the oclacitinib group ( 58.7 % ) than in the ciclosporin group ( 43.0 % ) .
-RESULTS	Three times as many adverse events attributed to gastrointestinal signs were reported in the ciclosporin group compared with the oclacitinib group .
-CONCLUSIONS	In this study of treatment for canine AD , oclacitinib had a faster onset of action and a lower frequency of gastrointestinal side effects compared with ciclosporin .
-
-###24392964
-OBJECTIVE	The purpose of this randomized , controlled clinical trial was to compare the effectiveness of a new treatment approach , which consisted of laterally positioned flap ( LPF ) procedure combined with an external vestibular releasing incision made by a diode laser ( LALPF ) to LPF alone for the treatment of isolated gingival recession defects .
-METHODS	Thirty-two healthy patients presenting single Miller class II isolated gingival recessions with minimal loss of interdental papilla were treated with an LPF technique .
-METHODS	Sixteen patients were randomly assigned to the test group ( laser-assisted laterally positioned flap [ LALPF ] ) , and the other 16 patients were assigned to the control group ( LPF ) .
-METHODS	In the test group , diode laser was used for vestibular deepening in order to obtain maximum maneuverability of the advanced flap .
-METHODS	Clinical and patient-centered parameters ( visual analog scale for pain and aesthetics [ VAS ] ) were measured at baseline , 7 days , and 6 months after the surgery .
-RESULTS	Complete root coverage from baseline to 6 months post-surgery was achieved for 46.7 % of the control group and 81.2 % of the test group ( p = 0.044 ) .
-RESULTS	There were no differences in VAS pain measurements between the groups .
-RESULTS	Patient satisfaction with aesthetics was higher in LALPF group than in the LPF group .
-CONCLUSIONS	Six month results showed that the LALPF approach was effective for the treatment of single Miller class II gingival recessions .
-
-###24981461
-OBJECTIVE	To evaluate the analgesic efficacy of oral premedication of oxycodone in a group of patients undergoing elective uterine artery embolization under sedation for fibroid disease .
-METHODS	Thirty-nine patients ( mean age 42.3 years ) were prospectively randomized 1:1 to receive 20 mg oxycodone or placebo orally immediately before their procedure .
-METHODS	At the commencement of the procedure , patients were provided with a patient-controlled analgesia device for 24 h , programmed to deliver 1 mg boluses of intravenous morphine with a 5 min lockout .
-METHODS	Mean visual analog scale pain intensity ratings ( 0-100 mm ) were measured from both groups and evaluated over 0 to 6 h as the primary end point .
-METHODS	Other measured parameters included opioid-related side effects and eligibility for discharge ( NCT00163930 ; September 12 , 2005 ) .
-RESULTS	Early pain intensity did not vary significantly between the active and placebo groups [ mean ( standard deviation ) : 3.2 ( 2.5 ) vs. 3.1 ( 2.2 ) , p = 0.89 ] .
-RESULTS	The oxycodone group , however , experienced significantly more nausea ( p = 0.035 ) and a greater incidence of vomiting ( p = 0.044 ) .
-RESULTS	Overall opioid requirement over 24 h , measured as oral morphine equivalent , was greater in the oxycodone group ( median [ interquartile range ] : 64.5 [ 45-90 ] mg vs. 22.5 [ 15-46 .5 ] mg , p < 0.0001 ) .
-RESULTS	The number of patients first eligible for discharge at 24 h in the oxycodone group was decreased but not significantly ( p = 0.07 ) .
-CONCLUSIONS	The addition of preprocedural oral oxycodone to morphine patient-controlled analgesia does not offer any analgesic advantage to patients having uterine artery embolization and may cause a greater incidence of nausea and vomiting .
-
-###24993832
-OBJECTIVE	In light of the high prevalence of sleep disorders in patients suffering from posttraumatic stress disorder ( PTSD ) , this study sought to compare the effect of prazosin and hydroxyzine on sleep quality in this patient group .
-METHODS	A total of 100 patients suffering from PTSD were assessed ( mean age = 35.51 years , SD = 6.41 ; 28 % females ) .
-METHODS	Next , they were randomly assigned to one of three treatment groups : prazosin ( 33 patients ) , hydroxyzine ( 34 patients ) or placebo ( 33 patients ) .
-METHODS	The trial lasted for 8 weeks .
-METHODS	The patients ' sleep quality was assessed using the Pittsburgh Sleep Quality Index .
-METHODS	Items taken from the Mini International Neuropsychiatric Interview were used to operationalize PTSD .
-RESULTS	Compared to controls , patients treated with prazosin and hydroxyzine reported improved sleep and less nightmares .
-RESULTS	Improvement was greatest in patients treated with prazosin compared to hydroxyzine and placebo .
-RESULTS	Improvement in sleep was associated with an amelioration of their PTSD symptoms .
-CONCLUSIONS	Both prazosin and hydroxyzine can be used to treat psychopharmacological sleep disorders and nightmares in patients suffering from PTSD , also leading to reductions in PTSD symptoms .
-
-###24939928
-BACKGROUND	Reinfarction after primary percutaneous coronary intervention in patients with ST-segment-elevation myocardial infarction has negative consequences .
-BACKGROUND	Little is known about reinfarction after drug-eluting stents and bivalirudin anticoagulation .
-BACKGROUND	We , therefore , sought to determine the incidence , predictors , and implications of reinfarction after primary percutaneous coronary intervention in the contemporary era .
-RESULTS	Outcomes were assessed in 3202 patients undergoing stent implantation for ST-segment-elevation myocardial infarction in the Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction ( HORIZONS-AMI ) trial .
-RESULTS	Independent predictors of reinfarction and mortality were identified by Cox proportional hazards modeling .
-RESULTS	The cumulative incidence of reinfarction was 1.8 % at 30 days , 4.0 % at 1 year , and 6.9 % at 3 years .
-RESULTS	Definite stent thrombosis was responsible for 76.3 % of reinfarctions occurring within 30 days and 52.0 % of all reinfarctions within 3 years .
-RESULTS	Independent predictors of reinfarction were current smoking , Killip class 2 , baseline thrombocytosis , multivessel disease , symptom onset-to-balloon time , and total stent length .
-RESULTS	Randomization to bivalirudin versus heparin plus a glycoprotein IIb/IIIa inhibitor and use of drug-eluting versus bare metal stents were not significant predictors of reinfarction .
-RESULTS	Reinfarction was a powerful independent predictor of subsequent cardiac mortality ( hazard ratio [ 95 % confidence interval ] = 7.65 [ 4.47-13 .09 ] ; P < 0.0001 ) and all-cause mortality ( hazard ratio [ 95 % confidence interval ] = 2.88 [ 1.74-4 .78 ] ; P < 0.0001 ) .
-CONCLUSIONS	Despite advances in pharmacotherapy and stents , reinfarction after primary percutaneous coronary intervention is not infrequent , in the contemporary era is most often attributable to stent thrombosis , and is strongly associated with subsequent cardiac and all-cause mortality .
-CONCLUSIONS	Further enhancements in drugs and devices to prevent reinfarction are needed to improve outcomes in high-risk patients with ST-segment-elevation myocardial infarction .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00433966 .
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-###24935363
-BACKGROUND	The aim of this study was to evaluate the efficacy of alternating etoposide-cisplatin and vinorelbine-cisplatin ( EP-NP ) compared with an etoposide-cisplatin ( EP ) regimen for advanced combined small cell carcinomas .
-METHODS	Histologically confirmed combined small cell carcinoma patients who met the inclusion criteria were randomly assigned ( 1:1 ) into either the EP-NP setting ( group A ) or the EP setting ( group B ) .
-METHODS	The primary endpoint was progression-free survival in patients who received at least one dose of treatment .
-RESULTS	Eighty-two patients entered into this trial , 42 in group A and 40 in group B.
-RESULTS	The objective response rates in group A and group B were 42.9 % and 32.5 % , respectively ( p = 0.334 ) .
-RESULTS	Survival analysis showed that median progression-free survival was 6.1 months in group A , which was significantly longer than the 4.1 months in group B ( p = 0.041 ) .
-RESULTS	However , as to overall survival , no significant difference was found between the two groups ( 11.0 vs 10.1 months in groups A and B , respectively , p = 0.545 ) .
-RESULTS	No unexpected side effects were observed in either group .
-CONCLUSIONS	The EP-NP regimen for combined small cell carcinomas prolonged progression - free survival compared with the EP regimen .
-CONCLUSIONS	Further clinical investigations are warranted .
-
-###25455119
-BACKGROUND	Limited evidence exists regarding the long-term effects of community health worker-led diabetes management programs on health outcomes and cost-effectiveness , particularly in low-income , ethnic minority populations .
-OBJECTIVE	To examine the long-term cost-effectiveness and improvements in diabetes-related complications of a diabetes education and management intervention led by community health workers among uninsured Mexican Americans .
-METHODS	Clinical data , changes in hemoglobin A1c over 12 months , and costs from an RCT of 180 uninsured Mexican Americans with type 2 diabetes conducted in 2006 were utilized for secondary analyses in 2012 .
-METHODS	Simulation modeling was used to estimate long-term cost and health outcomes using the validated Archimedes Model .
-METHODS	The absolute differences for the incremental cost-effectiveness ratios and cumulative incidence of diabetes-related complications were derived by comparing intervention and control groups .
-RESULTS	During a 20-year time horizon , participants who received the intervention would be expected to have significantly lower hemoglobin A1c levels ( p < 0.001 ) , fewer foot ulcers ( p < 0.001 ) , and a reduced number of foot amputations ( p = 0.005 ) in comparison with a control group receiving usual medical care .
-RESULTS	An incremental cost-effectiveness ratio of $ 355 per quality-adjusted life year gained was estimated for intervention participants during the same time period .
-CONCLUSIONS	A simulated clinical trial suggests that a community health worker-led diabetes intervention is a cost-effective way to reduce diabetes-related complications for uninsured Mexican Americans during a 20-year horizon in comparison to usual medical care .
-
-###25047046
-BACKGROUND	We report on the design and implementation of a study protocol entitled Acupuncture randomised trial for post anaesthetic recovery and postoperative pain - a pilot study ( ACUARP ) designed to investigate the effectiveness of acupuncture therapy performed in the perioperative period on post anaesthetic recovery and postoperative pain .
-METHODS	The study is designed as a randomised controlled pilot trial with three arms and partial double blinding .
-METHODS	We will compare ( a ) press needle acupuncture , ( b ) no treatment and ( c ) press plaster acupressure in a standardised anaesthetic setting .
-METHODS	Seventy-five patients scheduled for laparoscopic surgery to the uterus or ovaries will be allocated randomly to one of the three trial arms .
-METHODS	The total observation period will begin one day before surgery and end on the second postoperative day .
-METHODS	Twelve press needles and press plasters are to be administered preoperatively at seven acupuncture points .
-METHODS	The primary outcome measure will be time from extubation to ` ready for discharge ' from the post anaesthesia care unit ( in minutes ) .
-METHODS	The ` ready for discharge ' end point will be assessed using three different scores : the Aldrete score , the Post Anaesthetic Discharge Scoring System and an In-House score .
-METHODS	Secondary outcome measures will comprise pre - , intra - and postoperative variables ( which are anxiety , pain , nausea and vomiting , concomitant medication ) .
-CONCLUSIONS	The results of this study will provide information on whether acupuncture may improve patient post anaesthetic recovery .
-CONCLUSIONS	Comparing acupuncture with acupressure will provide insight into potential therapeutic differences between invasive and non-invasive acupuncture techniques .
-BACKGROUND	NCT01816386 ( First received : 28 October 2012 ) .
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-###25002367
-OBJECTIVE	A startling loud acoustic stimulus can involuntarily elicit planned movements , a phenomenon referred to as startReact .
-OBJECTIVE	Following stroke , startReact elbow flexion in stroke survivors are improved from voluntary movements .
-OBJECTIVE	Specifically , startReact elbow flexion in unimpaired individuals is not statistically different from stroke survivors in terms of onset latency and muscle activation patterns .
-OBJECTIVE	As hand movements are particularly impacted by stroke , our objective was to determine if startReact was intact in the hand following stroke .
-METHODS	Data were collected in 8 stroke survivors and 10 age-matched subjects performing hand extension following two non-startling acoustic stimuli representing `` get ready '' and `` go '' respectively .
-METHODS	Randomly , the `` go '' was replaced with a startling acoustic stimulus .
-METHODS	We hypothesized that ( 1 ) startReact would be intact during hand extension in stroke survivors and that ( 2 ) the latency of movement would be the same as in age-matched subjects .
-RESULTS	We found that startReact was intact in stroke subjects and further that the onset latency of these movements was not different from age-matched subjects .
-CONCLUSIONS	We conclude that startReact is intact in the hand following stroke .
-CONCLUSIONS	An intact startReact response indicates that this reflex may be an attractive therapeutic target for initiating hand extension in stroke survivors .
-
-###25167350
-BACKGROUND	One of the most challenging aspects of a revision knee arthroplasty is the management of bone loss .
-BACKGROUND	The OBJECTIVE of the study is to show the capability to augment bone mineral density in areas with bone loss with platelet-derived growth factors .
-METHODS	Randomized , prospective , blinded study in patients who underwent a total knee replacement revision with tibial-damaged metaphyseal bone were randomly allocated to have a revision total knee arthroplasty and to fill the bone defects with lyophilized bone allograft mixed with platelet growth factors ( experimental group , n = 9 ) or with lyophilized bone allograft alone ( control group , n = 7 ) .
-METHODS	To evaluate bone mineral density between groups , dual-energy X-ray absorptiometry ( DEXA ) was performed preoperatively , at 1 month , 6 months and 1 year after surgery .
-RESULTS	The study was comprised of a total of 16 patients .
-RESULTS	We found no significant differences observed during the follow-up between groups in mineral bone density .
-CONCLUSIONS	Use of platelet-derived growth factors does not improve bone mineral density in patients with revision knee arthroplasty .
-
-###24695894
-BACKGROUND	The greater presence of supermarkets in low-income , high-minority neighborhoods has the potential to positively affect diet quality among those at greatest risk of obesity .
-BACKGROUND	In-store marketing strategies that draw attention to healthier products may be effective , sustainable , and scalable for improving diet quality and health .
-BACKGROUND	Few controlled studies of in-store marketing strategies to promote sales of healthier items in low-income , high-minority neighborhoods have been conducted .
-OBJECTIVE	The objective of this study was to evaluate the effects of in-store marketing strategies to promote the purchase of specific healthier items in 5 product categories : milk , ready-to-eat cereal , frozen meals , in-aisle beverages , and checkout cooler beverages .
-METHODS	The design was a cluster-randomized controlled trial conducted from 2011 to 2012 .
-METHODS	Eight urban supermarkets in low-income , high-minority neighborhoods were the unit of randomization , intervention , and analysis .
-METHODS	Stores were matched on the percentage of sales from government food-assistance programs and store size and randomly assigned to an intervention or control group .
-METHODS	The 4 intervention stores received a 6-mo , in-store marketing intervention that promoted the sales of healthier products through placement , signage , and product availability strategies .
-METHODS	The 4 control stores received no intervention and were assessment-only controls .
-METHODS	The main outcome measure was weekly sales of the targeted products , which was assessed on the basis of the stores ' sales data .
-RESULTS	Intervention stores showed significantly greater sales of skim and 1 % milk , water ( in aisle and at checkout ) , and 2 of 3 types of frozen meals compared with control store sales during the same time period .
-RESULTS	No differences were found between the stores in sales of cereal , whole or 2 % milk , beverages , or diet beverages .
-CONCLUSIONS	These data indicate that straightforward placement strategies can significantly enhance the sales of healthier items in several food and beverage categories .
-CONCLUSIONS	Such strategies show promise for significant public health effects in communities with the greatest risk of obesity .
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-###25573882
-OBJECTIVE	This study examined the association between cardiac autonomic dysfunction and high albumin-to-creatinine ratio ( ACR ) in adolescents with type 1 diabetes .
-METHODS	Adolescents recruited as part of a multicenter screening study ( n = 445 , 49 % female , aged 10-17 years , mean duration 6.9 years ; mean HbA1c 8.4 % , 68 mmol/mol ) underwent a 10-min continuous electrocardiogram recording for heart rate variability analysis .
-METHODS	Time-domain heart rate variability measures included baseline heart rate , SD of the R-R interval ( SDNN ) , and root mean squared difference of successive R-R intervals ( RMSSD ) .
-METHODS	Spectral analysis included sympathetic ( low-frequency ) and parasympathetic ( high-frequency ) components .
-METHODS	Standardized ACR were calculated from six early morning urine collections using an established algorithm , reflecting age , sex , and duration , and stratified into ACR tertiles , where the upper tertile reflects higher nephropathy risk .
-RESULTS	The upper-tertile ACR group had a faster heart rate ( 76 vs. 73 bpm ; P < 0.01 ) and less heart rate variability ( SDNN 68 vs. 76 ms , P = 0.02 ; RMSSD 63 vs. 71 ms , P = 0.04 ) .
-RESULTS	HbA1c was 8.5 % ( 69 mmol/mmol ) in the upper tertile vs. 8.3 % ( 67 mmol/mol ) in the lower tertiles ( P = 0.07 ) .
-RESULTS	In multivariable analysis , upper-tertile ACR was associated with faster heart rate ( = 2.5 , 95 % CI 0.2-4 .8 , P = 0.03 ) and lower RMSSD ( = -9.5 , 95 % CI -18.2 to -0.8 , P = 0.03 ) , independent of age and HbA1c .
-CONCLUSIONS	Adolescents at potentially higher risk for nephropathy show an adverse cardiac autonomic profile , indicating sympathetic overdrive , compared with the lower-risk group .
-CONCLUSIONS	Longitudinal follow-up of this cohort will further characterize the relationship between autonomic and renal dysfunction and the effect of interventions in this population .
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-###24296748
-OBJECTIVE	According to mathematical modeling , intradialytic exercise of sufficient intensity and duration implemented in the second half of dialysis should be as efficacious as increasing dialysis time for dialysis adequacy .
-OBJECTIVE	This assumption has not been tested in vivo .
-METHODS	In this controlled trial , 11 hemodialysis ( HD ) patients ( mean ( SD ) age 56 ( 13 ) years ) were recruited .
-METHODS	Each patient completed three trial arms in a randomized order : routine care ( CONT ) , increased HD time of 30 min ( TIME ) , and intradialytic exercise ( EXER ) , 60 min of cycling at 90 % of the lactate threshold in the last 90 min of HD .
-METHODS	The primary outcome was eKt/Vurea .
-METHODS	Secondary outcomes included reduction and rebound ratios of urea , creatinine , phosphate and 2-microglobulin .
-METHODS	Outcomes were calculated from blood sampling collected pre - , post - and 30 min post-HD and confirmed with dialysate sampling .
-RESULTS	Exercise was not as efficacious as increased HD time for eKt/Vurea ( EXER vs. CONT , mean change ( 95 % CI ) : 0.03 ( -0.05 to 0.12 ) ; TIME vs. CONT : 0.15 ( 0.05-0 .26 ) ) .
-RESULTS	Exercise was less efficacious at improving reduction ratios of urea and creatinine .
-RESULTS	However , exercise was more efficacious than increased dialysis time for phosphate reduction ratio ( EXER vs. CONT : 8.6 % ( 0.5-16 .7 ) ; TIME vs. CONT : 5.0 % ( -1.0 to 11.1 ) ) .
-CONCLUSIONS	This study utilized a rigorously controlled in vivo design to test mathematical models and assumptions regarding dialysis adequacy .
-CONCLUSIONS	Intradialytic exercise towards the end of HD can not replace the prescription of increased HD time for dialysis adequacy , but may be an adjunctive therapy for serum phosphate control .
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-###24508475
-BACKGROUND	Previous observational studies examining outcomes associated with the timing of dialysis therapy initiation in the United States have often been limited by lead time and survivor bias .
-METHODS	Retrospective cohort study comparing the effectiveness of early versus later ( conventional ) dialysis therapy initiation in advanced chronic kidney disease ( CKD ) .
-METHODS	The analysis used inverse probability weighting to account for an individual 's contribution to different exposure groups over time in a pooled logistic regression model .
-METHODS	Patients contributed risk to both exposure categories ( early and later initiation ) until there was a clear treatment strategy ( ie , dialysis therapy was initiated early or estimated glomerular filtration rate [ eGFR ] decreased to < 10mL/min/1 .73 m ( 2 ) ) .
-METHODS	Patients with CKD who had at least one face-to-face outpatient encounter with a Cleveland Clinic health care provider as of January 1 , 2005 , and at least 3 eGFRs in the range of 20-30mL / min/1 .73 m ( 2 ) measured at least 180 days apart .
-METHODS	Timing of dialysis therapy initiation as determined using model-based interpolation of eGFR trajectories over time .
-METHODS	Timing was defined as early ( interpolated eGFR at dialysis therapy initiation10mL/min/1 .73 m ( 2 ) ) or later ( eGFR < 10mL/min/1 .73 m ( 2 ) ) and was time-varying .
-RESULTS	Death from any cause occurring from the time that eGFR was equal to 20mL/min/1 .73 m ( 2 ) through September 15 , 2009 .
-RESULTS	The study population consisted of 652 patients meeting inclusion criteria .
-RESULTS	Most ( 71.3 % ) of the study population did not initiate dialysis therapy during follow-up .
-RESULTS	Patients who did not initiate dialysis therapy ( n = 465 ) were older , more likely to be white , and had more favorable laboratory profiles than those who started dialysis therapy .
-RESULTS	Overall , 146 initiated dialysis early and 80 had eGFRs decrease to < 10mL/min/1 .73 m ( 2 ) .
-RESULTS	Many participants ( n = 426 ) were censored prior to attaining a clear treatment strategy and were considered undeclared .
-RESULTS	There was no statistically significant survival difference for the early compared with later initiation strategy ( OR , 0.85 ; 95 % CI , 0.65-1 .11 ) .
-CONCLUSIONS	Interpolated eGFR , moderate sample size , and likely unmeasured confounders .
-CONCLUSIONS	In patients with advanced CKD , timing of dialysis therapy initiation was not associated with mortality when accounting for lead time bias and survivor bias .
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-###24841015
-BACKGROUND	Bianchi and Squire introduced single high trans-scrotal incision for mobilisation of palpable undescended testes to decrease the potential morbidity of the traditional inguinal approach .
-BACKGROUND	This incision has not gained widespread acceptance and there is still a considerable debate about its efficacy .
-BACKGROUND	This study evaluated the outcome of high single scrotal incision in comparison to the classic inguinal exploration for unilateral palpable testes regardless to its pre-operative location to assure its validity and safety .
-METHODS	This was a randomised controlled study conducted on seventy males with palpable unilateral undescended testicles from November 2009 to October 2013 .
-METHODS	They were divided into two equal groups ; group I had high single scrotal incision and group II had the classic inguinal approach .
-METHODS	The comparative parameters between both groups were the operative time , intra-and post-operative complications , post-operative pain and scar .
-RESULTS	There was statistical significant difference between both groups regarding the operative time ( P < 0.001 ) .
-RESULTS	The high scrotal approach ( Group I ) was not completed in three cases and were converted to the classic inguinal approach .
-RESULTS	No statistical significant difference between both groups regarding the post-operative complications .
-CONCLUSIONS	Single high scrotal incision orchidopexy for palpable undescended testis is safe , has shorter operative time but may not be suitable for proximally lying testis .
-
-###25578255
-OBJECTIVE	Intravitreal antiangiogenic therapy is the major therapeutic breakthrough in neovascular age-related macular degeneration ( AMD ) .
-OBJECTIVE	Optical coherence tomography ( OCT ) is the leading diagnostic tool , but solid criteria for optimal therapeutic outcomes are lacking .
-OBJECTIVE	A comprehensive analysis of structure/function correlations using Food and Drug Administration - and European Medicines Agency-approved substances and fixed and flexible regimens was performed .
-METHODS	Post hoc analysis of a prospective , randomized multicenter clinical trial including 189 study sites .
-METHODS	A total of 1240 patients with active neovascular AMD .
-METHODS	Participants received intravitreal ranibizumab or aflibercept .
-METHODS	A fixed regimen was used for 48 weeks followed by a flexible regimen until week 96 .
-METHODS	At monthly intervals , best-corrected visual acuity ( BCVA ) was measured and retinal morphology was assessed by standardized OCT , including intraretinal cysts ( IRCs ) , subretinal fluid ( SRF ) , and pigment epithelial detachment ( PED ) , presenting with a width 400 m or a height of 200 m. Results were correlated for each regimen , feature , and time .
-METHODS	The BCVA outcomes in relation to retinal pathomorphology based on noninferiority for all treatment arms .
-RESULTS	In neovascular AMD , only IRC at baseline and persistent through week 12 had a negative impact on BCVA .
-RESULTS	With therapeutic intervention , exudative features such as IRC and SRF resolved rapidly in 74 % of eyes , whereas PED responded only slowly with 38 % .
-RESULTS	Independent of the type of regimen , fixed or flexible , retinal morphology correlated tightly with visual function .
-RESULTS	Intraretinal cysts consistently showed the lowest BCVA gains with either regimen or substance .
-RESULTS	With the switch from a fixed to a flexible pro re nata ( PRN ) regimen , progressive visual loss occurred exclusively in the group with primary PED presenting as the hallmark of neovascular activity and was induced by secondary formation of IRC in the neurosensory retina .
-CONCLUSIONS	The efficacy of antiangiogenic therapy in neovascular AMD is strongly determined by morphologic features .
-CONCLUSIONS	The subretinal pigment epithelium lesion underlying PED appears to be the primary indicator for progressive disease activity , whereas secondary cystoid degeneration is the most relevant imaging marker for visual function .
-CONCLUSIONS	Clinically , PED emerged as trigger for consecutive vision loss in PRN treatment .
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-###24690511
-BACKGROUND	The present article presents the protocol for a randomised controlled trial to test the effectiveness of a group-based self-management support programme for recently diagnosed type 2 diabetes mellitus ( T2DM ) patients ( one to three years post-diagnosis ) and their partners .
-BACKGROUND	The course aims to support T2DM patients and their partners in successfully integrating diabetes care into their daily lives and hereby enhance self-management and diabetes-specific health-related quality of life .
-BACKGROUND	The content of the course is based on the Common-Sense Model of Self-Regulation ( CSM ) .
-BACKGROUND	Furthermore , principles from the Social Cognitive Theory ( SCT ) and social support theories are integrated .
-METHODS	We aim to recruit 160 recently diagnosed T2DM patients and their partners from general practices in six different regions in the Netherlands .
-METHODS	Patients need to be diagnosed with T2DM for one to three years and have to experience some degree of diabetes-related difficulties , as measured with a three-item screener .
-METHODS	Participating patients and their partners are randomly allocated to the intervention or control condition .
-METHODS	Participants in the intervention condition receive three monthly group sessions and a booster session three months later .
-METHODS	Participants in the control condition receive a single information meeting .
-METHODS	Data will be collected at baseline ( T0 ) , directly after the programme ( T1 ) and six months post-programme ( T2 ) , including : self-management , diabetes-specific health-related quality of life , illness perceptions , attitudes , social support and empowerment .
-METHODS	A three-level multilevel model will be used to compare change-scores between the conditions ( intervention/control ) on each outcome .
-CONCLUSIONS	Our study will be the first to determine whether a group-based support programme based on the CSM is effective in enhancing self-management and diabetes-specific health-related quality of life in recently diagnosed T2DM patients .
-CONCLUSIONS	The important role of patients ' partners in effective diabetes care is also acknowledged in the study .
-BACKGROUND	Netherlands National Trial Register ( NTR ) NTR3302 .
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-###24262278
-OBJECTIVE	We evaluated an all-oral regimen comprising the nucleotide polymerase inhibitor sofosbuvir ( SOF ) with the NS5A inhibitor ledipasvir ( LDV ) or the NS5B non-nucleoside inhibitor GS-9669 in patients with genotype 1 hepatitis C virus ( HCV ) infection .
-METHODS	A total of 113 patients were enrolled .
-METHODS	Sofosbuvir ( 400 mg once daily ) and LDV ( 90 mg once daily ) plus ribavirin ( RBV ) were given for 12 weeks to treatment-nave ( TN ) patients ( n = 25 ) and those who did not respond to previous therapy ( prior null responders , n = 9 ) .
-METHODS	Sofosbuvir and GS-9669 ( 500 mg once daily ) plus RBV were given for 12 weeks to TN patients ( n = 25 ) and prior null responders ( n = 10 ) .
-METHODS	Additionally , prior null responders with cirrhosis were randomly assigned to groups given a fixed-dose combination of SOF and LDV , with RBV ( n = 9 ) or without RBV ( n = 10 ) .
-METHODS	Finally , a group of TN patients received SOF , LDV , and RBV for 6 weeks ( n = 25 ) .
-METHODS	The primary efficacy end point was sustained virologic response 12 weeks after therapy ( SVR12 ) .
-RESULTS	SVR12 was achieved by 25 of 25 ( 100 % ) TN patients receiving SOF , LDV , and RBV and 23 of 25 ( 92 % ) of those receiving SOF , GS-9669 , and RBV .
-RESULTS	Of TN patients receiving 6 weeks of SOF , LDV , and RBV , 17 of 25 ( 68 % ) achieved SVR12 .
-RESULTS	All noncirrhotic prior null responders receiving 12 weeks of SOF along with another direct-acting antiviral agent plus RBV achieved SVR12-9 of 9 ( 100 % ) of those receiving SOF , LDV , and RBV and 10 of 10 ( 100 % ) of those receiving SOF , GS-9669 , and RBV .
-RESULTS	Among cirrhotic prior null responders , SVR12 was achieved by 9 ( 100 % ) of those receiving SOF , LDV , and RBV and 7 ( 70 % ) of those receiving SOF and LDVD without RBV .
-RESULTS	The most common reported adverse events were headache , fatigue , and nausea .
-CONCLUSIONS	The combination of SOF and a second direct-acting antiviral agent is highly effective in TN patients with HCV genotype 1 infection and in patients that did not respond to previous treatment .
-CONCLUSIONS	ClinicalTrials.gov ID NCT01260350 .
-
-###25077855
-OBJECTIVE	Religious involvement may help individuals with chronic medical illness cope better with physical disability and other life changes .
-OBJECTIVE	We examine the relationships between religiosity , depressive symptoms , and positive emotions in persons with major depression and chronic illness .
-METHODS	129 persons who were at least somewhat religious/spiritual were recruited into a clinical trial to evaluate the effectiveness of religious vs. secular cognitive behavioral therapy .
-METHODS	Reported here are the relationships at baseline between religious involvement and depressive symptoms , purpose in life , optimism , generosity , and gratefulness using standard measures .
-RESULTS	Although religiosity was unrelated to depressive symptoms ( F = 0.96 , p = 0.43 ) and did not buffer the disability-depression relationship ( B = -1.56 , SE 2.90 , p = 0.59 ) , strong relationships were found between religious indicators and greater purpose , optimism , generosity , and gratefulness ( F = 7.08 , p < 0.0001 ) .
-CONCLUSIONS	Although unrelated to depressive symptoms in the setting of major depression and chronic medical illness , higher religious involvement is associated with positive emotions , a finding which may influence the course of depression over time .
-
-###25626984
-OBJECTIVE	Sleep and ongoing cycling of sleep states are required for neurosensory processing , learning , and brain plasticity .
-OBJECTIVE	Many aspects of neonatal intensive care environments such as handling for routine and invasive procedures , bright lighting , and noise can create stress , disrupt behavior , and interfere with sleep in prematurely born infants .
-OBJECTIVE	The study empirically investigated whether a 30-minute observation of infant sleep states and behavior could differentiate an intervention to promote sleep in premature infants with feeding difficulties relative to conventional care ( standard positioning , standard crib mattress [ SP ] ) .
-OBJECTIVE	We included an intervention to determine the ability of the method to discriminate treatments and generate a benchmark for future improvements .
-OBJECTIVE	The intervention , a conformational positioner ( CP ) , is contoured around the infant to provide customized containment and boundaries .
-OBJECTIVE	To more fully verify the 30-minute observational sleep results , standard polysomnography was conducted simultaneously and sleep outcomes for the 2 modalities were compared .
-METHODS	In a randomized crossover clinical trial , 25 infants , 31.5 0.6 weeks ' gestational age and 38.4 0.6 weeks at the study , with gastrointestinal conditions or general feeding difficulties used each intervention during an overnight neonatal intensive care unit sleep study .
-METHODS	Infant sleep states and behaviors were observed during two 30-minute periods -- that is , on the positioner and mattress -- using the naturalistic observation of newborn behavior .
-METHODS	Two certified developmental care nurses assessed sleep state , self-regulatory , and stress behaviors during 2-minute intervals and summed over 30 minutes .
-METHODS	Sleep characteristics from standard polysomnography were measured at the time of behavior observations .
-RESULTS	Infants on CP spent significantly less time in alert , active awake , or crying states by observation compared with SP .
-RESULTS	Surgical subjects spent more time awake , active awake , or crying and displayed a higher number of behavior state changes than the nonsurgical infants .
-RESULTS	The percentage of time in observed deep sleep and quiet sleep was correlated with both percentage sleep efficiency ( r = 0.78 ) and fewer state shifts per hour ( r = -0.65 ) from electroencephalogram ( EEG ) .
-RESULTS	Sleep efficiency by EEG was greater on CP versus SP .
-CONCLUSIONS	The CP enabled sleep compared with the standard mattress ( SP ) over 30-minute observation periods .
-CONCLUSIONS	Sleep status from behavioral observation was verified by standard EEG-based sleep techniques .
-CONCLUSIONS	Behavioral observation of sleep states may be a useful strategy for measuring the effectiveness of strategies to facilitate sleep in premature infants .
-CONCLUSIONS	Surgical subjects may benefit from additional interventions to promote sleep .
-
-###25574983
-BACKGROUND	Bronchiolitis is a common clinical problem in children below 2 years presenting with respiratory symptoms .
-BACKGROUND	As there is necrosis and sloughing of epithelial cells , edema , increased secretion of mucus causing obstruction of large and small airways we aim to see the clinical profile and the effect of use of hypertonic ( 3 % ) saline nebulization in these children .
-METHODS	A double blind randomized controlled trial was conducted at department of Pediatrics , in a hospital from July 2012 to August 2013 .
-METHODS	The computer generated random number was used to select the case and control group .
-METHODS	All eligible patients were randomly assigned to one of two groups : receiving inhalation of 4 ml normal ( 0.9 % ) saline or hypertonic ( 3 % ) saline .
-METHODS	Treating physicians , researchers and nurses were all blinded of the solution .
-METHODS	Both saline were kept in two identical containers and labeled as solution A and solution B. Patients in each group will receive three treatments on each day of hospitalization and clinical score were obtained 30 minutes before each inhalation session .
-RESULTS	Bronchiolitis accounted 11.26 % of total admissions .
-RESULTS	Their mean age ( SD ) was 8.56 ( 5.013 ) months with range from 45 days to 24 months .
-RESULTS	A total of 53 ( 74 % ) male were enrolled in the study .
-RESULTS	Fifty-seven ( 79 % ) children were less than 12 months and 15 ( 21 % ) were 12 months - 24 months .
-RESULTS	The mean ( SD ) for duration of hospital stay was 44.82 ( 23.15 ) and 43.60 ( 28.25 ) for 3 % and 0.9 % group respectively ( p = 0.86 ) .
-RESULTS	Likewise , mean ( SD ) duration of oxygen supplementation was 32.50 ( 20.44 ) and 34.50 ( 26.03 ) for 3 % and 0.9 % group respectively ( p = 0.85 ) .
-RESULTS	Moreover , time required for normalization of clinical score was 36.79 ( 19.53 ) and 38.34 ( 26.67 ) for 3 % and 0.9 % group respectively ( p = 0.80 ) .
-CONCLUSIONS	There is no advantage of hypertonic saline over normal saline nebulization in the management bronchiolitis .
-
-###25511923
-BACKGROUND	The IFCT-GFPC 0502 phase III study reported prolongation of progression-free survival with gemcitabine or erlotinib maintenance vs. observation after cisplatin-gemcitabine induction chemotherapy for advanced non-small-cell lung cancer ( NSCLC ) .
-BACKGROUND	This analysis was undertaken to assess the incremental cost-effectiveness ratio ( ICER ) of these strategies for the global population and pre-specified subgroups .
-METHODS	A cost-utility analysis evaluated the ICER of gemcitabine or erlotinib maintenance therapy vs. observation , from randomization until the end of follow-up .
-METHODS	Direct medical costs ( including drugs , hospitalization , follow-up examinations , second-line treatments and palliative care ) were prospectively collected per patient during the trial , until death , from the primary health-insurance provider 's perspective .
-METHODS	Utility data were extracted from literature .
-METHODS	Sensitivity analyses were conducted .
-RESULTS	The ICERs for gemcitabine or erlotinib maintenance therapy were respectively 76,625 and 184,733 euros per quality-adjusted life year ( QALY ) .
-RESULTS	Gemcitabine continuation maintenance therapy had a favourable ICER in patients with PS = 0 ( 52,213 / QALY ) , in responders to induction chemotherapy ( 64,296 / QALY ) , regardless of histology ( adenocarcinoma , 62,292 / QALY , non adenocarcinoma , 83,291 / QALY ) .
-RESULTS	Erlotinib maintenance showed a favourable ICER in patients with PS = 0 ( 94,908 / QALY ) , in patients with adenocarcinoma ( 97,160 / QALY ) and in patient with objective response to induction ( 101,186 / QALY ) , but it is not cost-effective in patients with PS = 1 , in patients with non-adenocarcinoma or with stable disease after induction chemotherapy .
-CONCLUSIONS	Gemcitabine - or erlotinib-maintenance therapy had ICERs that varied as a function of histology , PS and response to first-line chemotherapy .
-
-###25417775
-BACKGROUND	Bevacizumab is associated with an increased risk of arterial thromboembolism ( ATE ) ; however , its effect on venous thromboembolism ( VTE ) remains controversial .
-BACKGROUND	Scant data exist on the factors that increase the risk of ATE/VTE in patients with prostate cancer .
-BACKGROUND	The authors investigated the association of bevacizumab treatment and clinical factors with ATE/VTE risk in patients who were treated on Cancer and Leukemia Group B ( CALGB ) trial 90401 .
-METHODS	Patients with metastatic , castration-resistant prostate cancer were randomized to receive docetaxel and prednisone with or without bevacizumab once every 21 days .
-METHODS	Cycle-to-event Cox regression models were used to investigate the association of bevacizumab with the incidence of grade 3 or greater ( 3 ) ATE and VTE .
-METHODS	Age , prior ATE/VTE , baseline antiplatelet/anticoagulant use , and VTE risk score ( based on leukocyte count , hemoglobin , platelet count , body mass index , and tumor location ) were evaluated in univariate and multivariable analyses .
-RESULTS	Of 1008 randomized patients , the odds of experiencing grade 3 ATE were significantly greater in those who received bevacizumab compared with those who received placebo ( odds ratio , 2.79 ; P = .02 ) , whereas an opposite trend was noted for grade 3 VTE ( odds ratio , 0.60 ; P = .08 ) .
-RESULTS	In the multivariable analysis , bevacizumab treatment ( hazard ratio [ HR ] , 3.00 ; P = .01 ) and age ( HR , 1.06 ; P = .02 ) were significantly associated with the risk of ATE ; whereas age ( HR , 1.05 ; P = .01 ) and VTE risk score ( HR , 1.83 ; P = .03 ) were significantly associated with the risk of VTE .
-CONCLUSIONS	Bevacizumab was significantly associated with a greater risk of ATE in patients with metastatic , castration-resistant prostate cancer , but it was not significantly associated with the risk of VTE .
-CONCLUSIONS	Understanding clinical factors that increase the risk for experiencing ATE/VTE is essential to mitigate the risks and reduce the burden of these prevalent complications in cancer care .
-
-###24703512
-BACKGROUND	Previous studies have reported that stretching of the calf musculature and the plantar fascia are effective management strategies for plantar heel pain ( PHP ) .
-BACKGROUND	However , it is unclear whether myofascial release ( MFR ) can improve the outcomes in this population .
-OBJECTIVE	To investigate whether myofascial release ( MFR ) reduces the pain and functional disability associated with plantar heel pain ( PHP ) in comparison with a control group receiving sham ultrasound therapy ( SUST ) .
-METHODS	Randomized , controlled , double blinded trial .
-METHODS	Nonprofit research foundation clinic in India .
-METHODS	Sixty-six patients , 17 men and 49 women with a clinical diagnosis of PHP were randomly assigned into MFR or a control group and given 12 sessions of treatment per client over 4 weeks .
-METHODS	The Foot Function Index ( FFI ) scale was used to assess pain severity and functional disability .
-METHODS	The primary outcome measure was the difference in FFI scale scores between week 1 ( pretest score ) , week 4 ( posttest score ) , and follow-up at week 12 after randomization .
-METHODS	Additionally , pressure pain thresholds ( PPT ) were assessed over the affected gastrocnemii and soleus muscles , and over the calcaneus , by an assessor blinded to the treatment allocation .
-RESULTS	The simple main effects analysis showed that the MFR group performed better than the control group in weeks 4 and 12 ( P < 0.001 ) .
-RESULTS	Patients in the MFR and control groups reported a 72.4 % and 7.4 % reduction , respectively , in their pain and functional disability in week 4 compared with that in week 1 , which persisted as 60.6 % in the follow-up at week 12 in the MFR group compared to the baseline .
-RESULTS	The mixed ANOVA also revealed significant group-by-time interactions for changes in PPT over the gastrocnemii and soleus muscles , and the calcaneus ( P < 0.05 ) .
-CONCLUSIONS	This study provides evidence that MFR is more effective than a control intervention for PHP .
-
-###25171125
-OBJECTIVE	To evaluate the safety and effectiveness of radiofrequency dissection in conventional ` open ' total thyroidectomy .
-METHODS	Thirty-nine patients scheduled for conventional total thyroidectomy were included in a prospective randomised study .
-METHODS	Patients were randomly assigned to one of two groups : a radiofrequency dissection method was used in one group , and a knot tying technique was used in the other .
-RESULTS	Significantly fewer surgical instruments and materials were required for the radiofrequency dissection group than the knot tying group ( p < 0.01 ) .
-RESULTS	There were no significant differences between the two groups in mean operative time , blood loss , post-operative drainage and pain , recurrent palsy , and hypocalcaemia ( p > 0.05 ) .
-CONCLUSIONS	Radiofrequency dissection is a safe alternative to the knot tying technique , and enables a significant reduction in the number of surgical instruments required for the operation .
-
-###24330605
-BACKGROUND	Lactose intolerance ( LI ) is a common medical problem with limited treatment options .
-BACKGROUND	The primary symptoms are abdominal pain , diarrhea , bloating , flatulence , and cramping .
-BACKGROUND	Limiting dairy foods to reduce symptoms contributes to low calcium intake and the risk for chronic disease .
-BACKGROUND	Adaptation of the colon bacteria to effectively metabolize lactose is a novel and potentially useful approach to improve lactose digestion and tolerance .
-BACKGROUND	RP-G28 is novel galacto-oligosaccharide ( GOS ) being investigated to improve lactose digestion and the symptoms of lactose intolerance in affected patients .
-METHODS	A randomized , double-blind , parallel group , placebo-controlled study was conducted at 2 sites in the United States .
-METHODS	RP-G28 or placebo was administered to 85 patients with LI for 35 days .
-METHODS	Post-treatment , subjects reintroduced dairy into their daily diets and were followed for 30 additional days to evaluate lactose digestion as measured by hydrogen production and symptom improvements via a patient-reported symptom assessment instrument .
-RESULTS	Lactose digestion and symptoms of LI trended toward improvement on RP-G28 at the end of treatment and 30 days post-treatment .
-RESULTS	A reduction in abdominal pain was also demonstrated in the study results .
-RESULTS	Fifty percent of RP-G28 subjects with abdominal pain at baseline reported no abdominal pain at the end of treatment and 30 days post treatment ( p = 0.0190 ) .
-RESULTS	RP-G28 subjects were also six times more likely to claim lactose tolerance post-treatment once dairy foods had been re-introduced into their diets ( p = 0.0389 ) .
-CONCLUSIONS	Efficacy trends and favorable safety/tolerability findings suggest that RP-G28 appears to be a potentially useful approach for improving lactose digestion and LI symptoms .
-CONCLUSIONS	The concurrent reduction in abdominal pain and improved overall tolerance could be a meaningful benefit to lactose intolerant individuals .
-
-###25091062
-OBJECTIVE	Helicobacter pylori eradication rates with clarithromycin-based triple therapy are declining , and an alternative strategy is needed urgently .
-OBJECTIVE	We sought to compare the efficacy of pretreatment antimicrobial susceptibility-guided vs. clarithromycin-based triple therapy for H. pylori eradication in a region with high rates of multiple drug resistance .
-METHODS	Consecutive H. pylori-infected patients with gastric epithelial neoplasms were randomized to receive antimicrobial susceptibility-guided therapy or clarithromycin-based triple therapy for 7 days .
-METHODS	In patients in whom the infection was not eradicated , antibiotics were given according to an initial antimicrobial susceptibility test as a second-line therapy in both groups .
-METHODS	Eradication rates , antibiotics resistance rates , and drug compliance owing to adverse effects were compared between the groups .
-RESULTS	In total , 114 patients were enrolled , and 112 completed the protocols .
-RESULTS	Drug compliance and side effects were similar between the groups .
-RESULTS	The intention-to-treat eradication rates were 94.7 % ( 95 % confidence interval ( CI ) = 88.8-100 % , 54/57 ) in the antimicrobial susceptibility-guided group and 71.9 % ( 95 % CI = 60.2-83 .5 % , 41/57 ) in the clarithromycin-based triple therapy group after the initial treatment ( P = 0.002 ) , whereas the per-protocol ( PP ) eradication rates were 96.4 % ( 95 % CI = 91.5-100 % , 54/56 ) in the antimicrobial susceptibility-guided group and 73.2 % ( 95 % CI = 61.5-84 .8 % , 41/56 ) in the clarithromycin-based triple therapy group ( P = 0.001 ) .
-RESULTS	In H. pylori with clarithromycin resistance , the eradication failure rate with first-line treatment was lower in the susceptibility-guided therapy group ( 0 % , 0/12 ) compared with the clarithromycin-based triple therapy group ( 80.0 % , 95 % CI = 59.7-100 % , 12/15 ) by PP analysis ( P < 0.001 ) .
-CONCLUSIONS	Pretreatment antimicrobial susceptibility-guided therapy is more effective than clarithromycin-based triple therapy for H. pylori eradication in a region with high rates of multiple drug resistance .
-
-###25518878
-BACKGROUND	Persons with a mental health diagnosis have high rates of tobacco use and face numerous barriers to cessation including high levels of nicotine dependence , low rates of tobacco treatment referrals from mental health providers , and limited availability of tobacco treatment targeted to their needs .
-BACKGROUND	This manuscript describes the rationale and methods of a clinical trial with the following aims : 1 ) Compare the reach and efficacy of a proactive telephone-based tobacco cessation program for Veterans Health Administration ( VHA ) mental health clinic patients to VHA usual care and 2 ) Model longitudinal associations between baseline patient characteristics and long-term abstinence .
-METHODS	We will use the electronic medical record to identify patients across four VHA healthcare facilities who have a clinical reminder code indicating current tobacco use in the past six months and who have had a mental health clinic visit in the past 12 months .
-METHODS	We will send each patient an introductory letter and baseline survey .
-METHODS	Survey respondents ( N = 3840 ) will be randomized in a 1:1 fashion to intervention or control .
-METHODS	Control participants will receive VHA usual care .
-METHODS	Intervention participants will receive proactive motivational telephone outreach to offer tobacco treatment .
-METHODS	Intervention participants interested in treatment will receive eight weeks of nicotine replacement therapy plus eight sessions of specialized telephone counseling over two months , followed by monthly maintenance counseling for four months .
-METHODS	We will conduct telephone surveys with participants at six and 12 months to assess study outcomes .
-METHODS	We will collect a mailed saliva sample from patients reporting 7-day abstinence on the telephone surveys .
-METHODS	The primary outcome will be cotinine-validated abstinence at 12-month follow-up .
-CONCLUSIONS	Mental health patients are a high-risk smoking population with significant barriers to cessation .
-CONCLUSIONS	This study will evaluate the efficacy of a program that proactively reaches out to smokers with a mental health treatment history to engage them into telephone cessation counseling targeted to the needs of mental health patients .
-BACKGROUND	Clinicaltrials.gov : NCT01737281 ( registered November 5 , 2012 ) .
-
-###25456368
-BACKGROUND	An effective and well tolerated treatment is needed for patients with early HER2-positive breast cancer who do not achieve a pathological complete response after neoadjuvant therapy .
-BACKGROUND	The AVATAXHER trial aimed to predict pathological complete response early with the use of PET and to investigate whether the addition of bevacizumab could improve the proportion of patients achieving a pathological complete response in patients unlikely to respond to treatment .
-METHODS	AVATAXHER was a randomised , open-label , non-comparative , multicentre phase 2 study that enrolled women ( 18 years of age ) with early-stage HER2-positive breast cancer from 26 oncology centres in France .
-METHODS	Patients initially received two cycles of neoadjuvant docetaxel ( 100 mg/m ( 2 ) intravenously every 3 weeks ) plus trastuzumab ( 8 mg/kg intravenously every 3 weeks then 6 mg/kg intravenously every 3 weeks for the second course ) .
-METHODS	Before the first and second cycles , [ ( 18 ) F ] - fluorodeoxyglucose ( FDG ) PET was done and the change in standardised uptake value was used to predict pathological complete response in each patient .
-METHODS	Patients who were predicted to be responders on PET continued to receive standard therapy .
-METHODS	Predicted non-responders were randomly assigned ( 2:1 ) to receive four cycles of docetaxel ( 100 mg/m ( 2 ) intravenously every 3 weeks ) and trastuzumab ( 6 mg/kg intravenously every 3 weeks ) plus bevacizumab ( 15 mg/kg intravenously every 3 weeks ; group A ) or continue on docetaxel plus trastuzumab alone ( group B ) .
-METHODS	Randomisation was open label and was done by an adaptive minimisation method .
-METHODS	Although investigators and patients were aware of group assignment , the anatomo-pathologist in charge of centralised review of surgical samples and lymph nodes was masked to treatment assignment .
-METHODS	The primary endpoint was centrally assessed pathological complete response according to the Chevallier classification .
-METHODS	Efficacy analyses were done in the intention-to-treat population .
-METHODS	Safety analyses in this Article were done on all patients who received at least one dose of treatment starting from cycle 3 .
-METHODS	Survival outcomes are not yet mature .
-METHODS	This study is registered with ClinicalTrials.gov ( NCT01142778 ) and EUDRACT ( 2009-013410-26 ) .
-RESULTS	Between May 19 , 2010 , and Oct 1 , 2012 , 152 patients were recruited for the study .
-RESULTS	Ten patients were subsequently excluded , leaving 142 patients in the intention-to-treat population .
-RESULTS	Of these 142 patients , 69 were predicted by [ ( 18 ) F ] - FDG PET to be treatment responders after two cycles of treatment .
-RESULTS	The 73 predicted non-responders were randomly assigned to group A ( n = 48 ) and group B ( n = 25 ) .
-RESULTS	Pathological complete responses were noted in 37 ( 536 % , 95 % CI 412-657 ) of the PET responders , 21 ( 438 % , 295-588 ) of those in group A , and six ( 240 % , 94-451 ) of those in group B. Incidences of grade 3-4 adverse events were similar in all three groups .
-RESULTS	The most common grade 3-4 adverse events were neutropenia ( four in PET responders , five in group A , and three in group B ) , febrile neutropenia ( one , three , and one , respectively ) , and myalgia ( four , none , and one , respectively ) .
-RESULTS	Overall , 24 serious adverse events were reported in 15 patients ( PET responders : nine events in four [ 6 % ] of 67 patients ; group A : 14 events in ten [ 21 % ] of 47 patients ; group B : one event in one [ 4 % ] of 25 patients ) .
-RESULTS	No deaths occurred during the study .
-CONCLUSIONS	In patients with HER2-positive breast cancer , early PET assessment can help to identify non-responders to neoadjuvant docetaxel plus trastuzumab therapy .
-CONCLUSIONS	In these patients , the addition of bevacizumab can increase the proportion of patients achieving a pathological complete response .
-CONCLUSIONS	This potential new role for PET and the activity of bevacizumab in this setting need to be confirmed in larger phase 3 trials .
-BACKGROUND	Roche France .
-
-###25367165
-OBJECTIVE	To describe secondary analyses from a 12-week , randomized , open-label trial where adult schizophrenia outpatients receiving risperidone , olanzapine , or aripiprazole were switched to iloperidone .
-METHODS	Patients were randomized into two groups : one where the antecedent antipsychotic dose was titrated downwards to zero over 2 weeks ( n = 240 ) , and the other group where the antecedent antipsychotic was abruptly stopped ( n = 260 ) .
-METHODS	Adaptations of the Clinical Global Impression scale were used to evaluate clinical changes .
-METHODS	Other assessments included the reporting of adverse events ( AEs ) , study discontinuation , body weight , and metabolic variables .
-RESULTS	Improvement was steady throughout the study for both gradual - and immediate-switch groups starting at Week 1 and continuing through Week 12 .
-RESULTS	Discontinuations due to AEs in the first 2 weeks of treatment were higher for the immediate-switch group compared with the gradual-switch group ( 10.8 % vs. 5.4 % , NNT 19 , 95 % CI 10-151 ) .
-RESULTS	Fewer patients in the gradual-switch group experienced dizziness as an AE , whereas a higher percentage of patients in the immediate-switch group exhibited earlier onset of a therapeutic response within the first 2 weeks ; both groups were comparable thereafter with low rates of dizziness and similar efficacy outcomes .
-CONCLUSIONS	Switching to iloperidone can be accomplished either with a gradual crossover or immediate discontinuation of the prior antipsychotic ; however , the immediate-switch method is associated with greater proportion of initial dizziness .
-CONCLUSIONS	The observed outcomes are consistent with what has been previously reported regarding iloperidone 's favorable akathisia/EPS profile and modest impact on somnolence/sedation , body weight , and metabolic variables .
-
-###25609368
-BACKGROUND	When performing clinical trials involving acupuncture , it can be difficult to choose a placebo control .
-OBJECTIVE	To validate the Park sham needle for use as a double-blind control intervention .
-METHODS	Two different methods were employed .
-METHODS	First , a researcher blinded to needle type administered the Park sham or a real needle , chosen at random , on the arms of 16 healthy volunteers .
-METHODS	The researcher and the volunteers independently recorded which needle type they thought had been applied at each acupuncture point .
-METHODS	Second , 19 patients with shoulder impingement syndrome were randomly assigned to receive acupuncture applied with the real needle or the Park sham needle , once a week for 6 weeks alongside a course of physiotherapy .
-METHODS	At the end of the 6 sessions the patients recorded which needle type they thought was being used .
-METHODS	The results were analyzed with a Fisher 's exact test .
-METHODS	This study was carried out in the Outpatient Department of Physiotherapy in Charing Cross Hospital , London , UK , on healthy volunteers and patients with shoulder impingement pain .
-METHODS	The age range was 23 to 54 and 22 to 74 years respectively .
-RESULTS	Of the healthy volunteers , there was no difference ( P = 0.23 ) between the number of needles that were correctly ( n = 43 ) or incorrectly identified ( n = 53 ) .
-RESULTS	All patients thought that they had received the real needles .
-RESULTS	The researcher correctly identified all needles that were applied .
-CONCLUSIONS	The researcher delivering the acupuncture recognized the needle type .
-CONCLUSIONS	However , both healthy and patient volunteers were blind to the needle type .
-CONCLUSIONS	This demonstrates that the Park sham needle is an effective single-blind control .
-CONCLUSIONS	It should be noted that the number of patients recruited was small and the study was underpowered to detect an effect of treatment .
-
-###25738670
-BACKGROUND	The proteasome inhibitor bortezomib was initially approved for the treatment of relapsed mantle-cell lymphoma .
-BACKGROUND	We investigated whether substituting bortezomib for vincristine in frontline therapy with R-CHOP ( rituximab , cyclophosphamide , doxorubicin , vincristine , and prednisone ) could improve outcomes in patients with newly diagnosed mantle-cell lymphoma .
-METHODS	In this phase 3 trial , we randomly assigned 487 adults with newly diagnosed mantle-cell lymphoma who were ineligible or not considered for stem-cell transplantation to receive six to eight 21-day cycles of R-CHOP intravenously on day 1 ( with prednisone administered orally on days 1 to 5 ) or VR-CAP ( R-CHOP regimen , but replacing vincristine with bortezomib at a dose of 1.3 mg per square meter of body-surface area on days 1 , 4 , 8 , and 11 ) .
-METHODS	The primary end point was progression-free survival .
-RESULTS	After a median follow-up of 40 months , median progression-free survival ( according to independent radiologic review ) was 14.4 months in the R-CHOP group versus 24.7 months in the VR-CAP group ( hazard ratio favoring the VR-CAP group , 0.63 ; P < 0.001 ) , a relative improvement of 59 % .
-RESULTS	On the basis of investigator assessment , the median durations of progression-free survival were 16.1 months and 30.7 months , respectively ( hazard ratio , 0.51 ; P < 0.001 ) , a relative improvement of 96 % .
-RESULTS	Secondary end points were consistently improved in the VR-CAP group , including the complete response rate ( 42 % vs. 53 % ) , the median duration of complete response ( 18.0 months vs. 42.1 months ) , the median treatment-free interval ( 20.5 months vs. 40.6 months ) , and the 4-year overall survival rate ( 54 % vs. 64 % ) .
-RESULTS	Rates of neutropenia and thrombocytopenia were higher in the VR-CAP group .
-CONCLUSIONS	VR-CAP was more effective than R-CHOP in patients with newly diagnosed mantle-cell lymphoma but at the cost of increased hematologic toxicity .
-CONCLUSIONS	( Funded by Janssen Research and Development and Millennium Pharmaceuticals ; LYM-3002 ClinicalTrials.gov number , NCT00722137 . )
-
-###25693055
-OBJECTIVE	To investigate a new therapeutic strategy , with rapid corticosteroid dose tapering and limited cyclophosphamide ( CYC ) exposure , for older patients with systemic necrotizing vasculitides ( SNVs ; polyarteritis nodosa [ PAN ] , granulomatosis with polyangiitis [ Wegnener 's ] [ GPA ] , microscopic polyangiitis [ MPA ] , or eosinophilic GPA [ Churg-Strauss ] [ EGPA ] ) .
-METHODS	A multicenter , open-label , randomized controlled trial comprising patients 65 years old and newly diagnosed as having SNV was conducted .
-METHODS	The experimental treatment consisted of corticosteroids for 9 months and a maximum of six 500-mg fixed-dose intravenous ( IV ) CYC pulses , every 2-3 weeks , then maintenance azathioprine or methotrexate .
-METHODS	The control treatment included 26 months of corticosteroids for all patients , combined with 500 mg/m ( 2 ) IV CYC pulses , every 2-3 weeks until remission , then maintenance for all patients with GPA or MPA and for those with EGPA or PAN with a Five-Factors Score ( FFS ) of 1 .
-METHODS	Randomization used a 1:1 ratio computer-generated list and was performed centrally with sealed opaque envelopes .
-METHODS	The primary outcome measure was 1 serious adverse event ( SAE ) occurring within 3 years of followup .
-METHODS	Secondary outcome measures included remission and relapse rates .
-RESULTS	Among the 108 patients randomized , 4 were excluded ( early consent withdrawal or protocol violation ) .
-RESULTS	Mean SD age at diagnosis was 75.2 6.3 years .
-RESULTS	Analysis at 3 years included 53 patients ( 21 GPA , 21 MPA , 8 EGPA , and 3 PAN ) in the experimental arm and 51 patients ( 15 GPA , 23 MPA , 6 EGPA , and 7 PAN ) in the conventional arm .
-RESULTS	In total , 32 ( 60 % ) versus 40 ( 78 % ) had 1 SAE ( P = 0.04 ) , most frequently infections ; 6 ( 11 % ) versus 7 ( 14 % ) failed to achieve remission ( P = 0.71 ) ; 9 ( 17 % ) versus 12 ( 24 % ) died ( P = 0.41 ) ; and 20 ( 44 % ) of 45 versus 12 ( 29 % ) of 41 survivors in remission experienced a relapse ( P = 0.15 ) .
-CONCLUSIONS	For older SNV patients , an induction regimen limiting corticosteroid exposure and with fixed low-dose IV CYC pulses reduces SAEs in comparison to conventional therapy , and does not affect the remission rate .
-CONCLUSIONS	Three-year relapse rates remain high for both arms .
-
-###24256028
-OBJECTIVE	Acupuncture is increasingly used in patients with allergic asthma , but there is a lack of evidence on the cost-benefit relationship of this treatment .
-OBJECTIVE	The aim of this study was to assess economic aspects of additional acupuncture treatment in patients with allergic bronchial asthma compared to patients receiving routine care alone .
-OBJECTIVE	DESIGN , SUBJECTS , INTERVENTION , OUTCOME MEASURES : In a randomized controlled trial , patients with allergic bronchial asthma were either allocated to a group receiving acupuncture immediately or a waiting-list control group .
-OBJECTIVE	Both groups were free to use routine care treatment .
-OBJECTIVE	The resource consumption , costs , and health-related quality of life were evaluated at baseline , and after 3 and 6 months by using statutory health insurance information and standardized questionnaires .
-OBJECTIVE	Main economic outcome parameters were direct and indirect cost differences during the study period and the incremental cost-effectiveness ratio ( ICER ) of acupuncture treatment .
-RESULTS	Three hundred and six ( 306 ) patients ( 159 acupuncture ; 147 controls ) were included ( mean age 46.513.11 years , female 57.2 % ) and were comparable at baseline .
-RESULTS	Acupuncture treatment was associated with significantly higher costs compared to control patients ( overall costs : 860.76 [ 95 % confidence interval ( CI ) 705.04-1016 .47 ] versus 518.80 [ 95 % CI 356.66-680 .93 ] ; p = 0.003 ; asthma-related costs : 517.52 [ 95 % CI 485.63-549 .40 ] versus 144.87 [ 95 % CI 111.70-178 .05 ] ; p < 0.001 ) .
-RESULTS	These additional costs seem essentially driven by acupuncture costs themselves ( 378.40 [ 95 % CI 367.10-389 .69 ] ) .
-RESULTS	However , acupuncture was associated with superior effectiveness in terms of quality-adjusted life years ( QALYs ) .
-RESULTS	Resulting ICER lay between 23,231 ( overall ) and 25,315 ( diagnosis-specific ) per additional QALY .
-RESULTS	When using German acupuncture prices of year 2012 , the ICER would improve to 12.810 ( overall ) versus 14,911 ( diagnosis-specific ) per QALY gained .
-CONCLUSIONS	Treating patients who have allergic bronchial asthma with acupuncture in addition to routine care resulted in additional costs and better effects in terms of patients ' quality of life .
-CONCLUSIONS	Acupuncture therefore seems to be a useful and cost-effective add-on treatment .
-
-###24583294
-OBJECTIVE	The aim of this study was to assess whether deferred stenting might reduce no-reflow and salvage myocardium in primary percutaneous coronary intervention ( PCI ) for ST-segment elevation myocardial infarction ( STEMI ) .
-BACKGROUND	No-reflow is associated with adverse outcomes in STEMI .
-METHODS	This was a prospective , single-center , randomized , controlled , proof-of-concept trial in reperfused STEMI patients with 1 risk factors for no-reflow .
-METHODS	Randomization was to deferred stenting with an intention-to-stent 4 to 16 h later or conventional treatment with immediate stenting .
-METHODS	The primary outcome was the incidence of no - / slow-reflow ( Thrombolysis In Myocardial Infarction 2 ) .
-METHODS	Cardiac magnetic resonance imaging was performed 2 days and 6 months after myocardial infarction .
-METHODS	Myocardial salvage was the final infarct size indexed to the initial area at risk .
-RESULTS	Of 411 STEMI patients ( March 11 , 2012 to November 21 , 2012 ) , 101 patients ( mean age , 60 years ; 69 % male ) were randomized ( 52 to the deferred stenting group , 49 to the immediate stenting ) .
-RESULTS	The median ( interquartile range [ IQR ] ) time to the second procedure in the deferred stenting group was 9 h ( IQR : 6 to 12 h ) .
-RESULTS	Fewer patients in the deferred stenting group had no - / slow-reflow ( 14 [ 29 % ] vs. 3 [ 6 % ] ; p = 0.006 ) , no reflow ( 7 [ 14 % ] vs. 1 [ 2 % ] ; p = 0.052 ) and intraprocedural thrombotic events ( 16 [ 33 % ] vs. 5 [ 10 % ] ; p = 0.010 ) .
-RESULTS	Thrombolysis In Myocardial Infarction coronary flow grades at the end of PCI were higher in the deferred stenting group ( p = 0.018 ) .
-RESULTS	Recurrent STEMI occurred in 2 patients in the deferred stenting group before the second procedure .
-RESULTS	Myocardial salvage index at 6 months was greater in the deferred stenting group ( 68 [ IQR : 54 % to 82 % ] vs. 56 [ IQR : 31 % to 72 % ] ; p = 0.031 ] .
-CONCLUSIONS	In high-risk STEMI patients , deferred stenting in primary PCI reduced no-reflow and increased myocardial salvage .
-CONCLUSIONS	( Deferred Stent Trial in STEMI ; NCT01717573 ) .
-
-###24444862
-OBJECTIVE	Cognitive deficits that characterize schizophrenia are present in the prodrome , worsen with illness onset , and predict functional outcome .
-OBJECTIVE	Cognitive dysfunction is thus a critical target for early intervention in young individuals with recent onset schizophrenia .
-METHODS	This 2-site double-blind randomized controlled trial investigated cognitive training of auditory processing/verbal learning in 86 subjects with recent onset schizophrenia ( mean age of 21 years ) .
-METHODS	Subjects were given laptop computers to take home and were asked to perform 40 hours of training or 40 hours of commercial computer games over 8 weeks .
-METHODS	We examined cognitive measures recommended by the Measurement and Treatment Research to Improve Cognition in Schizophrenia initiative ( MATRICS ) , symptoms , and functioning .
-METHODS	We also assessed baseline reward anticipation to index motivational system functioning and measured changes in auditory processing speed after 20 hours of training to assess target engagement .
-RESULTS	Auditory training subjects demonstrated significant improvements in global cognition , verbal memory , and problem solving compared with those of computer games control subjects .
-RESULTS	Both groups showed a slight but significant decrease in symptoms and no change in functional outcome measures .
-RESULTS	Training-induced cognitive gains at posttraining showed significant associations with reward anticipation at baseline and with improvement in auditory processing speed at 20 hours .
-CONCLUSIONS	Neuroscience-informed cognitive training via laptop computer represents a promising treatment approach for cognitive dysfunction in early schizophrenia .
-CONCLUSIONS	An individual 's baseline motivational system functioning ( reward anticipation ) , and ability to engage in auditory processing speed improvement , may represent important predictors of treatment outcome .
-CONCLUSIONS	Future studies must investigate whether cognitive training improves functioning and how best to integrate it into critical psychosocial interventions .
-
-###25549639
-OBJECTIVE	To explore the possible mechanisms for improving lower extremity motor function in patients with early stroke through combining magnetic resonance diffusion tensor imaging ( DTI ) technology and functional electrical stimulation ( FES ) based on human walking patterns .
-METHODS	From August 2012 to September 2013 , a total of 48 eligible patients were stratified according to age , gender , disease course , Brunnstrom staging and types of stroke .
-METHODS	And the Minimize software was used to divided them randomly into four-channel FES group ( n = 18 ) , dual-channel FES group ( n = 15 ) and comfort stimulation group ( n = 15 ) .
-METHODS	For all three groups , general medication and standard rehabilitation were provided .
-METHODS	Based on normal walking pattern design of FES treatment , four-channel FES groups received the stimulations of quadriceps , hamstring , anterior tibialis and medial gastrocnemius .
-METHODS	For the dual-channel FES group , the stimulations of tibialis anterior , peroneus longus and peroneus brevis muscles were applied .
-METHODS	In comfort electrical stimulation group , the electrode positions were identical to the stimulation group , but there was no current output during stimulation .
-METHODS	Before and after 3-week treatment , three groups received weekly rehabilitation evaluations of Fugl-Meyer assessment ( FMA ) , posture assessment of stroke scale ( PASS ) , Brunel balance assessment ( BBA ) , Berg balance scale ( BBS ) and modified Barthel index ( MBI ) .
-METHODS	Before and after treatment , DTI examination was performed for some patients .
-RESULTS	Among three groups , general patient profiles and pre-treatment evaluations showed no significant difference .
-RESULTS	For intra-group comparisons versus pre-treatment , at week 1 , 2 and 3 , the scores of PASS , BBA , BBS , FMA and MBI had statistically significant differences ( P < 0.05 ) ; At week 3 post-treatment , when four-channel and double-channel FES groups were compared versus pre-treatment , the scores of ipsilateral FA had statistically significant differences ( P < 0.05 ) .
-RESULTS	At week 1 post-treatment , MBI had statistically significant difference among 3 groups ( P = 0.037 ) .
-RESULTS	As compared with placebo , four-channel group had statistically significant difference [ ( 52 12 ) vs ( 38 18 ) , P < 0.05 ] ; At week 2 post-treatment , the scores of PASS and MBI were ( 29 3 , 73 13 ) in four-channel FES group versus ( 24 8 , 60 17 ) in dual-channel FES group .
-RESULTS	And the scores of PASS , BBA , BBS , FMA and MBI were ( 9 3 , 8.3 2.4 , 37 7 , 22 5 , 73 13 ) in four-channel FES group versus ( 21 7 , 6.2 3.1 , 24 16 , 15 8 , 47 20 ) in comfort electrical stimulation group .
-RESULTS	When dual-channel FES and comfort stimulation groups were compared , MBI had significant statistical difference [ ( 60 17 ) vs ( 47 20 ) , P < 0.05 ] .
-RESULTS	At week 3 post-treatment , four-channel and dual-channel FES groups were compared , there was also statistical significance in FMA [ ( 25 5 ) vs ( 20 7 ) , P = 0.055 ] .
-RESULTS	The scores of PASS , BBS , FMA and MBI were ( 31 3 , 43 8 , 25 5 , 81 13 ) in four-channel FES group versus ( 25 8 , 29 17 , 17 9 , 54 25 ) in comfort stimulation group respectively .
-RESULTS	When dual-channel FES and comfort stimulation groups were compared , the scores of MBI were ( 71 15 ) and ( 54 25 ) respectively .
-RESULTS	And the difference was statistically significant ( P < 0.05 ) .
-RESULTS	At week 3 post-treatment , the scores of FA significantly increased [ four-channel FES group ( 0.321 0.172 ) vs comfort stimulation group ( 0.217 0.135 ) ( P = 0.020 ) ] .
-RESULTS	When dual-channel FES group ( 0.333 0.164 ) and comfort stimulation group ( 0.217 0.135 ) ( P = 0.049 ) were compared , the differences were statistically significant .
-RESULTS	DTI showed that four-channel FES group increased significantly , but contralateral fiber bundle was not obvious .
-RESULTS	And the improvements of dual-channel FES and comfort stimulation groups were insignificant .
-CONCLUSIONS	Compared with traditional dual-channel FES , functional electrical stimulation based on human walking patterns is more efficacious .
-CONCLUSIONS	And it helps to restore brain structure and function and promote motor function recovery in patients with early stroke .
-
-###24439636
-OBJECTIVE	This study sought to determine the effects of lavender aromatherapy on pain following needle insertion into a fistula in patients undergoing hemodialysis .
-METHODS	This is a randomized controlled clinical trial in which 92 patients undergoing hemodialysis with arteriovenous fistulas were randomly divided into two groups .
-METHODS	The experimental-group patients inhaled lavender essence with a concentration of 10 % for 5min during 3 hemodialysis sessions , while the control-group patients received aromatherapy free of lavender essence .
-RESULTS	The mean VAS pain intensity score in the experimental and control groups before the intervention was 3.780.24 and 4.160.32 , respectively ( p = 0.35 ) .
-RESULTS	The mean VAS pain intensity score in the experimental and control groups after three aromatherapy sessions was 2.360.25 and 3.430.31 , respectively ( p = 0.009 ) .
-CONCLUSIONS	Lavender aromatherapy may be an effective technique to reduce pain following needle insertion into a fistula in hemodialysis patients .
-
-###25262224
-BACKGROUND	Hyperparathyroidism ( HPT ) in multiple endocrine neoplasia ( MEN ) type 1 is associated with multiglandular parathyroid disease .
-BACKGROUND	Previous retrospective studies comparing subtotal parathyroidectomy ( SP ) and total parathyroidectomy with autotransplantation ( TP/AT ) have not established clearly better outcomes with either procedure .
-METHODS	Patients were assigned randomly to either SP or TP/AT and data were collected prospectively .
-METHODS	The rates of persistent HPT , recurrent HPT , and postoperative hypoparathyroidism were compared .
-RESULTS	The study cohort included 32 patients randomized to receive either SP or TP/AT ( mean follow-up , 7.5 5.7 years ) .
-RESULTS	The overall rate of recurrent HPT was 19 % ( 6/32 ) .
-RESULTS	Recurrent HPT occurred in 4 of 17 patients ( 24 % ) treated with SP and 2 of 15 patients ( 13 % ) treated with TP/AT ( P = .66 ) .
-RESULTS	Permanent hypoparathyroidism occurred in 3 of 32 patients ( 9 % ) overall .
-RESULTS	The rate of permanent hypoparathyroidism was 12 % in the SP group ( 2/17 ) and 7 % in the TP/AT group ( 1/15 ) .
-RESULTS	A second operation was performed in 4 of 17 patients initially treated with SP ( 24 % ) , compared with 1 of 15 patients undergoing TP/AT ( 7 % ; P = .34 ) .
-CONCLUSIONS	This randomized trial of SP and TP/AT in patients with MEN 1 failed to show any difference in outcomes when comparing results of SP versus TP/AT .
-CONCLUSIONS	Both procedures are associated with acceptable results , but SP may have advantages in that is involves only 1 surgical incision and avoids an obligate period of transient postoperative hypoparathyroidism .
-
-###25260232
-BACKGROUND	Adhesions develop in over 90 % of patients after intra-abdominal surgery .
-BACKGROUND	Adhesion barriers are rarely used despite the high morbidity caused by intra-abdominal adhesions .
-BACKGROUND	Only one of the currently available adhesion barriers has demonstrated consistent evidence for reducing adhesions in visceral surgery .
-BACKGROUND	This agent has limitations through poor handling characteristics because it is sticky on both sides .
-BACKGROUND	C-Qur Film is a novel thin film adhesion barrier and it is sticky on only one side , resulting in better handling characteristics .
-BACKGROUND	The objective of this study is to assess efficacy and safety of C-Qur Film to decrease the incidence of adhesions after colorectal surgery .
-METHODS	This is a prospective , investigator initiated , randomized , double-blinded , multicenter trial .
-METHODS	Eligible patients undergoing colorectal resection requiring temporary loop ileostomy or loop/split colostomy by laparotomy or hand assisted laparoscopy will be included in the trial .
-METHODS	Before closure , patients are randomized 1:1 to either the treatment arm ( C-Qur Film ) or control arm ( no adhesion barrier ) .
-METHODS	Patients will return 8 to 16 weeks post-colorectal resection for take down of their ostomy .
-METHODS	During ostomy takedown , adhesions will be evaluated for incidence , extent , and severity .
-METHODS	The primary outcome evaluation will be assessment of adhesions to the incision site .
-METHODS	It is hypothesized that the use of C-Qur Film underneath the primary incision reduces the incidence of adhesion at the incision by 30 % .
-METHODS	To demonstrate 30 % reduction in the incidence of adhesions , a sample size of 84 patients ( 32 + 10 per group ( 25 % drop out ) ) is required ( two-sided test , = 0.05 , 80 % power ) .
-CONCLUSIONS	Results of this study add to the evidence on the use of anti-adhesive barriers in open and laparoscopic ` hand-assisted ' colorectal surgery .
-CONCLUSIONS	We chose incidence of adhesions to the incision site as primary outcome measure since clinical outcomes such as small bowel obstruction , secondary infertility and adhesiolysis related complications are considered multifactorial and difficult to interpret .
-CONCLUSIONS	Incidence of adhesions at repeat surgery is believed to be the most valuable surrogate endpoint for clinically relevant adhesion prevention , since small bowel obstruction and adhesiolysis at repeat surgery are not likely to occur when complete adhesion reduction in a patient is accomplished .
-BACKGROUND	ClinicalTrials.gov Identifier NCT01872650 , registration date 6 June 2013 .
-
-###24914427
-OBJECTIVE	To assess the impact of empowerment ( health coaching , HC ) on toothbrushing self-efficacy ( TBSE ) and toothbrushing frequency ( TB ) and their effects on diabetes management ( HbA1c , physical activity ) and quality of life in comparison to health education ( HE ) among patients with diabetes type 2 ( DM2 ) .
-METHODS	The data ( HbA1c [ glycated haemoglobin ] , TB , physical activity , TBSE , quality of life ) were collected at baseline and at post-intervention at outpatient clinics of two hospitals in Istanbul , Turkey .
-METHODS	Participants were allocated randomly to HC ( n = 77 ) and HE ( n = 109 ) groups .
-RESULTS	At baseline , there were no statistical differences between HC and HE groups in terms of all measures ( P > 0.05 ) .
-RESULTS	At post-intervention , there was improvement in oral health - and diabetes-related variables in the HC group , whereas only TBSE and TB slightly improved in the HE group ( P < 0.05 ) .
-RESULTS	At post-intervention among patients brushing their teeth at least once a day , HC group patients were more likely to be physically active and to have high self-efficacy than those in HE group ( P < 0.01 ) .
-RESULTS	TBSE was correlated with favourable HbA1c levels ( < 6.5 % ) in the HC group and quality of life ( P < 0.05 ) in both groups .
-CONCLUSIONS	The findings show that HC-based empowerment towards improving self-efficacy is more effective at improving toothbrushing behaviour than is HE and that interaction contributes significantly to diabetes management in terms of reduced HbA1c , increased physical activity and quality of life .
-CONCLUSIONS	TBSE can be a practical starting point for empowerment and toothbrushing can be used as an effective and practical behaviour to observe personal success in diabetes management .
-
-###24595505
-BACKGROUND	Previous research has shown limited efficacy of nicotine replacement therapy ( NRT ) among adolescents and generally low compliance rates .
-BACKGROUND	As higher compliance rates are associated with improved abstinence rates , the present study examined predictors of NRT compliance .
-OBJECTIVE	This study aims to test whether different NRT compliance trajectories can be distinguished among adolescents , to test whether these trajectories can be predicted by demographic , smoking-related , and personality factors , and to examine abstinence rates for each trajectory .
-METHODS	Data were used from a randomized controlled trial that tested the efficacy of nicotine patches versus placebo patches among 265 Dutch adolescents .
-METHODS	During NRT treatment , adolescents filled out six online questionnaires in which they reported on the number of days they used the patches .
-METHODS	Predictors ( i.e. , demographic and smoking-related factors and personality characteristics ) and end-of-treatment abstinence were also administered through these self-reports .
-METHODS	Latent class growth analysis ( LCGA ) was used to analyze compliance data by classifying individuals into similar growth trajectories .
-RESULTS	Three compliance trajectories were found ( i.e. , `` compliers '' ( n = 89 ) , `` moderate decreasers '' ( n = 41 ) , and `` strong decreasers '' ( n = 127 ) ) .
-RESULTS	The compliers can be characterized by higher levels of conscientiousness and agreeableness and lower levels of extraversion compared with the strong decreasers , and by higher levels of conscientiousness and education compared with the moderate decreasers .
-RESULTS	Among the compliers , a substantially higher percentage of adolescents achieved abstinence at end-of-treatment ( 10 % ) compared with the moderate decreasers ( 3 % ) and the strong decreasers ( 6 % ) .
-CONCLUSIONS	These findings could be the starting point for person-tailored interventions that aim to enhance NRT compliance rates among adolescents .
-
-###24493237
-OBJECTIVE	This study investigates the efficacy of the 6-hour REACH Forgiveness intervention among culturally diverse undergraduates .
-METHODS	Female undergraduates ( N = 102 ) and foreign extraction ( 46.2 % ) and domestic ( 43.8 % ) students in the United States were randomly assigned to immediate treatment or waitlist conditions .
-METHODS	Treatment efficacy and the effect of culture on treatment response were assessed using measures of emotional and decisional forgiveness across 3 time periods .
-RESULTS	Students in the treatment condition reported greater improvement in emotional forgiveness , but not decisional forgiveness , relative to those in the waitlist condition .
-RESULTS	Gains were maintained at a 1-week follow-up .
-RESULTS	Although culture did not moderate the effect of treatment , a main effect of culture on emotional forgiveness and marginally significant interaction effect of culture on decisional forgiveness were found .
-CONCLUSIONS	The REACH Forgiveness intervention was efficacious for college students from different cultural backgrounds when conducted in the United States .
-CONCLUSIONS	However , some evidence may warrant development of culturally adapted forgiveness interventions .
-
-###25217122
-BACKGROUND	This study was designed to evaluate the safety and efficacy of a novel , self-cross-linked hyaluronic acid ( HA ) hydrogel compared with carboxymethylcellulose ( CMC ) viscous foam in promoting healing when applied after ethmoidectomy .
-BACKGROUND	A prospective , randomized , controlled , blinded clinical trial was performed .
-BACKGROUND	The study was performed by four surgeons operating in two community hospitals .
-METHODS	Thirty patients with bilateral chronic rhinosinusitis underwent bilateral total ethmoidectomy .
-METHODS	Intraoperatively , each patient received 5 mL of HA hydrogel in one ethmoid cavity and 5 mL of CMC contralaterally .
-METHODS	The material applied within each ethmoid cavity was randomly assigned before surgery .
-METHODS	An independent surgeon , blinded to the material used to treat each ethmoid cavity , evaluated postoperative endoscopic video at 1 and 2 weeks for edema , crusting , and mucopurulence and at 6 and 12 weeks for remucosalization and scarring/synechiae .
-METHODS	Twenty-item Sino-Nasal Outcome Test SNOT-20 data were collected at each visit .
-METHODS	A small sample underwent endoscopic mucosal biopsy .
-RESULTS	Twenty-nine of 30 patients completed the protocol .
-RESULTS	The difference in edema , crusting , and mucopurulence at 1 and 2 weeks was not statistically significant ; however , at 6 and 12 weeks , the HA hydrogel showed statistically significant reduction in both overall endoscopic grade ( p < 0.05 ) , as well as synechiae formation ( p < 0.05 ) , with a trend toward superiority in remucosalization ( p = 0.08 ) .
-RESULTS	Histological analysis of six subjects at 12 weeks showed a nonsignificant trend toward a greater amount of regenerated cilia present with the HA hydrogel ( p = 0.23 ) .
-RESULTS	SNOT-20 scores declined 78.8 % from preoperative scores .
-CONCLUSIONS	Self-cross-linked HA hydrogel provides superior wound healing to CMC after ethmoidectomy .
-
-###25555183
-OBJECTIVE	Although there is scientific evidence that stress adversely affects metabolic control , only a few studies have examined the role of stress management in improving glycemic control in patients with type 2 diabetes mellitus ( DM ) .
-OBJECTIVE	In this study , we investigated the effect of a relaxation technique on levels of stress and glycemic control .
-METHODS	A total of 53 patients with type 2 DM were randomly assigned to undergo either an 8-week stress management program , consisting of 10 min of diaphragmatic breathing and 15 min of progressive muscle relaxation twice per day ( n = 25 , intervention group ) , or not ( n = 28 , control group ) .
-METHODS	Perceived stress , health locus of control and HbA1c were primary outcomes and were measured before and after intervention .
-RESULTS	In the intervention group , perceived stress score ( PSS ) and HbA1c had decreased significantly ( P < 0.05 ) by the end of the program .
-RESULTS	Specifically concerning the PSS , the higher the initial levels of perceived stress the greater the benefit of the intervention .
-RESULTS	No other significant changes were found .
-CONCLUSIONS	Our results show a beneficial role of stress management for patients with type 2 DM , as regards both stress levels and glycemic control .
-CONCLUSIONS	It is recommended to consider this type of treatment as an adjunct to conventional therapy .
-CONCLUSIONS	We deem that our study could encourage future studies in this area with larger samples , longer duration and more objective measurements .
-
-###24427264
-BACKGROUND	Community-based peer support has been shown to be effective in improving exclusive breastfeeding rates in a variety of settings .
-METHODS	We conducted a cost analysis of a community cluster randomised-controlled trial ( Promise-EBF ) , aimed at promoting exclusive infant feeding in three sites in South Africa .
-METHODS	The costs were considered from the perspective of health service providers .
-METHODS	Peer supporters in this trial visited women to support exclusive infant feeding , once antenatally and four times postpartum .
-RESULTS	The total economic cost of the Promise-EBF intervention was US$ 393 656 , with average costs per woman and per visit of US$ 228 and US$ 52 , respectively .
-RESULTS	The average costs per woman and visit in an operational ` non research ' scenario were US$ 137 and US$ 32 per woman and visit , respectively .
-RESULTS	Investing in the promotion of exclusive infant feeding requires substantial financial commitment from policy makers .
-RESULTS	Extending the tasks of multi-skilled community health workers ( CHWs ) to include promoting exclusive infant feeding is a potential option for reducing these costs .
-RESULTS	In order to avoid efficiency losses , we recommend that the time requirements for delivering the promotion of exclusive infant feeding are considered when integrating it within the existing activities of CHWs .
-CONCLUSIONS	This paper focuses on interventions for exclusive infant feeding , but its findings more generally illustrate the importance of documenting and quantifying factors that affect the feasibility and sustainability of community-based interventions , which are receiving increased focus in low income settings .
-
-###25522928
-OBJECTIVE	The purpose of this study was to identify the effects of water-based exercises on the physical functions and quality of life ( QOL ) in community-dwelling elderly people with history of falling .
-METHODS	Participants were randomly assigned to the water-based exercise group ( n = 34 ) or land-based exercise groups ( n = 32 ) .
-METHODS	To identify the effects on physical functions , muscle strength , flexibility , and mobility were measured .
-METHODS	QOL and fear of falling were evaluated using the Short Form 36-item questionnaire and the modified falls efficacy scale ( M-FES ) .
-METHODS	The measurements were performed before and after the 10-week training period .
-RESULTS	Within-group analysis indicated that hip abduction and adduction strength improved significantly in both groups ( p = 0.005 ; p = 0.007 ) .
-RESULTS	However , no statistically significant within-group differences were found in the back scratch test ( p = 0.766 ) and chair sit-and-reach test ( p = 0.870 ) .
-RESULTS	QOL was significantly different in both groups ( health transition : p = 0.014 , physical functioning : p < 0.001 , role physical : p < 0.001 , role emotional : p = 0.002 , bodily pain : p < 0.001 , vitality : p < 0.001 , and mental health : p < 0.001 ) .
-RESULTS	There was a significant difference in the M-FES in both groups ( p = 0.040 ) .
-CONCLUSIONS	These results indicate that water-based exercises are beneficial to improve the QOL , as well as physical activities , of community-dwelling elderly compared with land-based exercise .
-CONCLUSIONS	Water-based exercises would be useful to improve physical and psychological health in the elderly people with history of falling .
-
-###24947817
-BACKGROUND	Urinary stone disease is common , with an estimated prevalence among the general population of 2 % to 3 % .
-BACKGROUND	Ureteric stones can cause severe pain and have a significant impact on quality of life , accounting for over 15,000 hospital admissions in England annually .
-BACKGROUND	Uncomplicated cases of smaller stones in the lower ureter are traditionally treated expectantly .
-BACKGROUND	Those who fail standard care or develop complications undergo active treatment , such as extracorporeal shock wave lithotripsy or ureteroscopy with stone retrieval .
-BACKGROUND	Such interventions are expensive , require urological expertise and carry a risk of complications.Growing understanding of ureteric function and pathophysiology has led to the hypothesis that drugs causing relaxation of ureteric smooth muscle , such as the selective - blocker tamsulosin and the calcium-channel blocker nifedipine , can enhance the spontaneous passage of ureteric stones .
-BACKGROUND	The use of drugs in augmenting stone passage , reducing the morbidity and costs associated with ureteric stone disease , is promising .
-BACKGROUND	However , the majority of clinical trials conducted to date have been small , poor to moderate quality and lacking in comprehensive economic evaluation.This trial aims to determine the clinical and cost-effectiveness of tamsulosin and nifedipine in the management of symptomatic urinary stones .
-METHODS	The SUSPEND ( Spontaneous Urinary Stone Passage ENabled by Drugs ) trial is a multicentre , double-blind , randomized controlled trial evaluating two medical expulsive therapy strategies ( nifedipine or tamsulosin ) versus placebo.Patients aged 18 to 65 with a ureteric stone confirmed by non-contrast computed tomography of the kidney , ureter and bladder will be randomized to receive nifedipine , tamsulosin or placebo ( 400 participants per arm ) for a maximum of 28days .
-METHODS	The primary clinical outcome is spontaneous passage of ureteric stones at 4weeks ( defined as no further intervention required to facilitate stone passage ) .
-METHODS	The primary economic outcome is a reduction in the incremental cost per quality-adjusted life years , determined at 12weeks .
-METHODS	The analysis will be based on all participants as randomized ( intention to treat ) .
-METHODS	The trial has 90 % power with a type I error rate of 5 % to detect a 10 % increase in primary outcome between the tamsulosin and nifedipine treatment groups .
-BACKGROUND	ISRCTN69423238 ; EudraCT number : 2010-019469-26 .
-
-###24434889
-OBJECTIVE	The aim of the present study was to evaluate the effects of upper thoracic manipulation on pain in subjects with temporomandibular disorder .
-METHODS	Thirty-two women with a diagnosis of temporomandibular disorder were randomly allocated to an experimental group ( n = 16 ) , submitted to upper thoracic manipulation , and a placebo group ( n = 16 ) , submitted to a procedure in the thoracic region with no therapeutic effect .
-METHODS	All volunteers underwent an evaluation of pain in the masticatory muscles and the temporomandibular joint using an algometer and the visual analog scale before and immediately after the procedure as well as after 48-72 hrs .
-METHODS	Two-way repeated-measures analysis of variance was used for the intragroup and intergroup analyses , with the level of significance set to 5 % ( P < 0.05 ) .
-METHODS	Cohen d was calculated for the determination of the effect size .
-RESULTS	No significant group-by-time interaction was found ( P > 0.05 ) for algometry in any analysis , and Cohen d revealed no significant effect of the treatment .
-RESULTS	Moreover , no significant group-by-time interaction was found for facial pain intensity determined using the visual analog scale ( P > 0.05 ) , and Cohen d also revealed no significant effect of the treatment regarding this variable .
-CONCLUSIONS	On the basis of the present findings , upper thoracic spinal manipulation does not lead to a reduction in pain in women with temporomandibular disorder .
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-###25089277
-OBJECTIVE	This study investigates the changes in hemorheologic parameters resulting from exercise followed by a standard meal .
-METHODS	In twelve moderately active men a period of exercise on a bicycle ergometer for 30 min at 60 % VO2max was followed by a test meal or by 30 min rest .
-METHODS	Venous blood was sampled for further analysis at baseline , after exercise , and after the meal/rest period .
-RESULTS	The elongation index ( EI ) was reduced and a marked rise in plasma viscosity was observed after exercise .
-RESULTS	A significant decrease in half time of total aggregation ( T 1/2 ) and a rise in aggregation index ( AI ) after exercise were observed ; however , after the postexercise period these changes were reversed .
-CONCLUSIONS	The present study demonstrates that physical exercise causes several changes in blood rheology parameters , such as an increase of blood viscosity , a decrease in EI and an increase in AI , and a fall in the T 1/2 values .
-CONCLUSIONS	The meal eaten in the postexercise period caused a further reduction in EI values indicating higher red cell rigidity , but not in plasma viscosity or aggregations indices .
-CONCLUSIONS	Such alterations in hemorheologic parameters should not impair the function of the cardiovascular system in fit and healthy people but it could constitute a serious risk under various pathophysiological conditions .
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-###25154949
-OBJECTIVE	Proximal and distal ( mid-thigh ) ultrasound-guided continuous adductor canal block techniques have been described but not yet compared , and infusion benefits or side effects may be determined by catheter location .
-OBJECTIVE	We hypothesized that proximal placement will result in faster onset of saphenous nerve anesthesia , without additional motor block , compared to a distal technique .
-METHODS	Preoperatively , patients receiving an ultrasound-guided nonstimulating adductor canal catheter for knee arthroplasty were randomly assigned to either proximal or distal insertion .
-METHODS	A local anesthetic bolus was administered via the catheter after successful placement .
-METHODS	The primary outcome was the time to achieve complete sensory anesthesia in the saphenous nerve distribution .
-METHODS	Secondary outcomes included procedural time , procedure-related pain and complications , postoperative pain , opioid consumption , and motor weakness .
-RESULTS	Proximal insertion ( n = 23 ) took a median ( 10th-90th percentiles ) of 12.0 ( 3.0-21 .0 ) minutes versus 6.0 ( 3.0-21 .0 ) minutes for distal insertion ( n = 21 ; P = .106 ) to anesthetize the medial calf .
-RESULTS	Only 10 of 25 ( 40 % ) and 10 of 24 ( 42 % ) patients in the proximal and distal groups , respectively , developed anesthesia at both the medial calf and top of the patella ( P = .978 ) .
-RESULTS	Bolus-induced motor weakness occurred in 19 of 25 ( 76 % ) and 16 of 24 ( 67 % ) patients in the proximal and distal groups ( P = .529 ) .
-RESULTS	Ten of 24 patients ( 42 % ) in the distal group required intravenous morphine postoperatively , compared to 2 of 24 ( 8 % ) in the proximal group ( P = .008 ) , but there were no differences in other secondary outcomes .
-CONCLUSIONS	Continuous adductor canal blocks can be performed reliably at both proximal and distal locations .
-CONCLUSIONS	The proximal approach may offer minor analgesic and logistic advantages without an increase in motor block .
-
-###24917557
-BACKGROUND	The health-promoting properties of apples are directly related to the biologically active compounds that they contain , such as polyphenols .
-BACKGROUND	The objective of this study was to prepare a low-sugar , fibre - and phlorizin-enriched powder from unripe apples and to gain insight regarding its anti-hyperglycaemic activity in healthy volunteers .
-RESULTS	The unripe apples ( Malus domestica Borkh . )
-RESULTS	were collected 30 days after the full bloom day ; blanched and pressed to obtain apple pomace which was then processed with a food cutter , oven-dried and milled to prepare apple powder .
-RESULTS	The concentrations of total sugars , water-soluble pectin and phlorizin in the apple preparation were 153.442.46 , 27.730.51 and 12.610.15 g kg ( -1 ) , respectively .
-RESULTS	Acute ingestion of the apple preparation improved glucose metabolism in the oral glucose tolerance test ( OGTT ) in six healthy volunteers by reducing the postprandial glucose response at 15 to 30 min by approximately two-fold ( P < 0.05 ) and by increasing urinary glucose excretion during the 2 - to 4-h interval of the OGTT by five-fold ( P < 0.05 ) .
-CONCLUSIONS	The results obtained indicate that the dried and powdered pomace of unripe apples can be used as a health-promoting natural product for the reduction of postprandial glycaemia and to improve the health of patients with diabetes .
-
-###25539281
-OBJECTIVE	The purpose of this study was to determine parents ' knowledge about pediatric fluoroscopic procedures and potential risk from ionizing radiation before and after being given an informational brochure .
-METHODS	We reviewed responses from 120 randomly selected participants who were parents or guardians of pediatric patients undergoing diagnostic fluoroscopic examinations .
-METHODS	A questionnaire assessed participants ' knowledge of the procedure , radiation exposure , and whether their child had a prior examination before and after receiving an informational brochure .
-METHODS	In a feedback survey , participants rated the brochure .
-METHODS	A repeated measures mixed model was used to evaluate the effect of the brochure on the participants ' knowledge .
-RESULTS	Participant demographics were women ( 79 % ) , English speaking ( 99 % ) , white ( 90 % ) , and education higher than 12th grade ( 76 % ) .
-RESULTS	The median age of patients undergoing the fluoroscopic examination was 4 years .
-RESULTS	Participant knowledge increased ( p < 0.0001 ) between pre - and postbrochure ( least-squares means ) for those without a previous examination from 38.3 to 63.4 ( total test score ) and from 46.3 to 61.8 for those with a prior examination .
-RESULTS	The proportion of correct answers was higher ( p < 0.0001 ) postbrochure compared with pre-brochure in areas of examination name ( 99 % vs 93 % ) , procedure details ( 97 % vs 87 % ) ; use of radiation ( 100 % vs 68 % ) , and radiation dose comparison ( 79 % vs 25 % ) .
-RESULTS	Overall , 99 % ( 119/120 ) rated the brochure `` good '' or `` great '' ( p < 0.0001 ) .
-CONCLUSIONS	An informational brochure given to participants before their child 's fluoroscopic procedure improved their knowledge of the examination and radiation exposure .
-CONCLUSIONS	No participants refused their child 's examination .
-
-###24491463
-BACKGROUND	It remains to be determined if perioperative systemic magnesium can improve postoperative quality of recovery of patients undergoing ambulatory procedures .
-BACKGROUND	The main objective of the current investigation was to evaluate the effect of systemic magnesium on postoperative quality of recovery in patients undergoing outpatient segmental mastectomies .
-METHODS	The study was a prospective randomized , double-blind , placebo-controlled , clinical trial .
-METHODS	Female subjects were randomized to receive intravenous magnesium ( MgSO4 50mg/kg in 100 mL of normal saline over 15 min before anesthesia induction , followed by an infusion of 15 mg/kg/hour ) or the same volume of saline .
-METHODS	The primary outcome was the Quality of Recovery 40 ( QOR-40 ) questionnaire at 24 hours after surgery .
-RESULTS	50 subjects were recruited and 46 completed the study .
-RESULTS	Patients in the magnesium group had better global Quality of Recovery scores compared with the saline group , with a median difference of 24 ( 99 % CI , 3 to 33 ) , P < 0.001 .
-RESULTS	After discharge from hospital , subjects in the magnesium group required less oral opioids , median ( IQR ) of 10 ( 0 to 20 ) ( oral milligrams of morphine equivalents ) than the saline group , 30 ( 20 to 40 ) ( P < 0.001 ) .
-RESULTS	The postoperative systemic magnesium concentrations were substantially higher in the magnesium group , 1.25 0.28 mmol/L compared to control , 0.71 0.11 mmol/L , P < 0.0001 .
-RESULTS	Simple linear regression demonstrated a direct linear relationship between the postoperative systemic magnesium concentrations and 24 hour postoperative quality of recovery scores ( P = 0.004 ) , and also an inverse relationship with pain burden in the postoperative care unit ( P = 0.01 ) .
-CONCLUSIONS	Systemic magnesium improves postoperative quality of recovery in patients undergoing outpatient segmental mastectomy .
-CONCLUSIONS	Systemic magnesium is a safe , inexpensive , efficacious strategy to improve quality of recovery after ambulatory surgery .
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-###24370820
-OBJECTIVE	We hypothesized that , after axillary block , positioning the patient in a lateral position with the injected side down and simultaneously in a 20 Trendelenburg position will increase the success rate and quality of the block .
-METHODS	Fifty patients with chronic renal failure ( ASA 2-3 ) scheduled for arteriovenous fistula surgery were included in this study .
-METHODS	In all patients , 30-40 ml of 0.25 % levobupivacaine were injected into the axillary sheath .
-METHODS	The block was performed as three injections ( multiple injection technique ) with the arm in 90 abduction and 90 flexion in the supine position .
-METHODS	Patients were randomly allocated to two groups .
-METHODS	Group I ( n = 25 ) patients were kept in the supine position after the block .
-METHODS	Group II ( n = 25 ) patients were positioned laterally after the block with the injected arm down and in a 20 Trendelenburg position .
-METHODS	Sensory and motor block were evaluated at 2 , 4 , 6 , 8 , 10 , 15 , 20 , and 25 min after the administration of the block .
-METHODS	Thus , the patients in group II were evaluated in a lateral position during the first 30 min .
-METHODS	Throughout the surgery and the recovery period , sensory and motor block were evaluated at 30-min intervals .
-RESULTS	There were no significant intergroup differences in the effects on radial , ulnar , median , and musculoskeletal nerve blockade .
-RESULTS	Thirty minutes after the injection , the patients in group II had higher levels of sensory axillary nerve blockade .
-RESULTS	Subscapular and thoracodorsal nerve motor block were not detected in group I , while 84 % of the patients in group II experienced blockade of both of these nerves ( p < 0.01 ) .
-CONCLUSIONS	We conclude that , for patients undergoing an axillary block , positioning the patient laterally with the injected side down and in a 20 Trendelenburg position increases the success rate and quality of the block .
-
-###24950280
-OBJECTIVE	The primary objective was to compare overall survival ( OS ) in patients with colorectal cancer ( CRC ) with nonresectable liver-only metastases treated by liver transplantation or chemotherapy .
-BACKGROUND	CRC is the third most common cancer worldwide .
-BACKGROUND	About 50 % of patients will develop metastatic disease primarily to the liver and the lung .
-BACKGROUND	The majority of patients with liver metastases receive palliative chemotherapy , with a median OS of trial patients of about 2 years , and less than 10 % are alive at 5 years .
-METHODS	Patients with nonresectable liver-only CRC metastases underwent liver transplantation in the SECA study ( n = 21 ) .
-METHODS	Disease-free survival ( DFS ) and OS of patients included in the SECA study were compared with progression-free survival ( PFS ) and OS in a similar cohort of CRC patients with liver-only disease included in a first-line chemotherapy study , the NORDIC VII study ( n = 47 ) .
-METHODS	PFS/DFS and OS were estimated by the Kaplan-Meier method .
-RESULTS	DFS/PFS in both groups were 8 to 10 months .
-RESULTS	However , a dramatic difference in OS was observed .
-RESULTS	The 5-year OS rate was 56 % in patients undergoing liver transplantation compared with 9 % in patients starting first-line chemotherapy .
-RESULTS	The reason for the large difference in OS despite similar DFS/PFS is likely different metastatic patterns at relapse/progression .
-RESULTS	Relapse in the liver transplantation group was often detected as small , slowly growing lung metastases , whereas progression of nonresectable liver metastases was observed in the chemotherapy group .
-CONCLUSIONS	Compared with chemotherapy , liver transplantation resulted in a marked increased OS in CRC patients with nonresectable liver-only metastases .
-
-###26076387
-BACKGROUND	The I-gel ( IG ) supraglottic airway device is a reliable way to establish an airway .
-BACKGROUND	Its large ventilation lumen allows for easy passage of an endotracheal tube .
-BACKGROUND	With the use of a flexible bronchoscope , the IG offers a good visualization of the laryngeal inlet .
-BACKGROUND	This prospective randomized study aims to compare the success rate of flexible bronchoscope-guided tracheal intubation using either the IG or the LMA-Fastrach ( FT ) laryngeal masks .
-METHODS	One hundred twenty patients requiring general anesthesia were randomized to 1 of the 2 study groups : IG or FT. After anesthesia induction , the assigned laryngeal mask was inserted to obtain adequate ventilation .
-METHODS	We then proceeded to a flexible bronchoscope-guided intubation through the supraglottic device .
-METHODS	Tracheal intubation and laryngeal mask insertion success rates were noted , as well as the time required for these manipulations .
-METHODS	The view of the laryngeal inlet was graded for each intubation attempt .
-RESULTS	Sixty patients were assigned to each study group .
-RESULTS	The intubation success rates were similar between the IG and the FT groups ( 100 % vs 95.0 % at first attempt ; P = 0.12 ) .
-RESULTS	The times required for tracheal intubation were significantly lower in the IG group ( 30 11 seconds vs 50 21 seconds ; P < 0.0001 ) .
-RESULTS	Glottic visualization was better in the IG group , with a significantly higher percentage of grade 1 visualization ( 63.3 % vs 3.3 % ; P < 0.0001 ) and a lower percentage of grade 3 visualization ( 1.7 % vs 60.0 % ; P < 0.0001 ) , than that in the FT group .
-CONCLUSIONS	The use of the IG supraglottic airway device as a conduit for flexible bronchoscope-guided tracheal intubation results in a success rate equivalent to the use of the LMA-FT .
-CONCLUSIONS	However , the IG allows for shorter intubation times and a better visualization of the glottic opening compared with the LMA-FT .
-
-###24638843
-OBJECTIVE	Critically ill patients are at risk of venous thrombosis , and therefore guidelines recommend daily thromboprophylaxis .
-OBJECTIVE	Deep vein thrombosis ( DVT ) commonly occurs in the lower extremities but can occur in other sites including the head and neck , trunk , and upper extremities .
-OBJECTIVE	The risk of nonleg deep venous thromboses ( NLDVTs ) , predisposing factors , and the association between NLDVTs and pulmonary embolism ( PE ) or death are unclear .
-OBJECTIVE	To describe the frequency , anatomical location , risk factors , management , and consequences of NLDVTs in a large cohort of medical-surgical critically ill adults .
-METHODS	A nested prospective cohort study in the setting of secondary and tertiary care intensive care units ( ICUs ) .
-METHODS	The study population comprised 3746 patients , who were expected to remain in the ICU for at least 3 days and were enrolled in a randomized clinical trial of dalteparin vs standard heparin for thromboprophylaxis .
-METHODS	The proportion of patients who had NLDVTs , the mean number per patient , and the anatomical location .
-METHODS	We characterized NLDVTs as prevalent or incident ( identified within 72 hours of ICU admission or thereafter ) and whether they were catheter related or not .
-METHODS	We used multivariable regression models to evaluate risk factors for NLDVT and to examine subsequent anticoagulant therapy , associated PE , and death .
-METHODS	RESULTS Of 3746 trial patients , 84 ( 2.2 % ) developed 1 or more non-leg vein thromboses ( superficial or deep , proximal or distal ) .
-METHODS	Thromboses were more commonly incident ( n = 75 [ 2.0 % ] ) than prevalent ( n = 9 [ 0.2 % ] ) ( P < .001 ) and more often deep ( n = 67 [ 1.8 % ] ) than superficial ( n = 31 [ 0.8 % ] ) ( P < .001 ) .
-METHODS	Cancer was the only independent predictor of incident NLDVT ( hazard ratio [ HR ] , 2.22 ; 95 % CI , 1.06-4 .65 ) .
-METHODS	After adjusting for Acute Physiology and Chronic Health Evaluation ( APACHE ) II scores , personal or family history of venous thromboembolism , body mass index , vasopressor use , type of thromboprophylaxis , and presence of leg DVT , NLDVTs were associated with an increased risk of PE ( HR , 11.83 ; 95 % CI , 4.80-29 .18 ) .
-METHODS	Nonleg DVTs were not associated with ICU mortality ( HR , 1.09 ; 95 % CI , 0.62-1 .92 ) in a model adjusting for age , APACHE II , vasopressor use , mechanical ventilation , renal replacement therapy , and platelet count below 50 10 ( 9 ) / L. CONCLUSIONS AND RELEVANCE Despite universal heparin thromboprophylaxis , nonleg thromboses are found in 2.2 % of medical-surgical critically ill patients , primarily in deep veins and proximal veins .
-METHODS	Patients who have a malignant condition may have a significantly higher risk of developing NLDVT , and patients with NLDVT , compared with those without , appeared to be at higher risk of PE but not higher risk of death .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00182143 .
-
-###24899242
-BACKGROUND	Osteoarthritis is a leading cause of disability in developed nations .
-BACKGROUND	In Australia it afflicts 16.5 % of the adult population .
-BACKGROUND	Total joint arthroplasty is considered the treatment of choice for end stage osteoarthritis .
-BACKGROUND	The number of total joint arthroplasties undertaken in Australia has doubled over the last decade ( more than 80,000 procedures in 2011 ) .
-BACKGROUND	The incidence of pre-operative psychological distress in this group of patients is reported between 30 % and 60 % and pre-operative psychological distress is associated with poorer pain and functional outcomes after surgery .
-BACKGROUND	This study will use a mindfulness-based psychological intervention to enhance outcomes in people undergoing total joint arthroplasty and , in addition , will test hypotheses about coping with chronic illness in an aged population .
-BACKGROUND	This study is the first of its kind and will provide a greater understanding of the role of a mental health enhancement program on the physical recovery of total joint arthroplasty patients .
-METHODS	One hundred and fifty people with end-stage arthritis on the waiting list for total hip or knee arthroplasty will be recruited and randomly allocated to one of two groups using computer-generated block randomisation .
-METHODS	A randomised controlled trial adhering to CONSORT guidelines will evaluate the efficacy of a mindfulness training program ( weekly group-based classes in mindfulness practice , 2 hours , for 8weeks plus a 7-hour Saturday session in Week 6 ) prior to total joint arthroplasty , compared to a `` standard care '' group who will undergo routine total joint arthroplasty .
-METHODS	Primary outcomes will be evaluated by a blinded examiner at baseline , 3 and 12months post-surgery , using a validated self-reported pain and physical function scale .
-METHODS	Secondary outcomes will include i ) a range of validated measures of psychological wellbeing and ii ) health economic analysis .
-METHODS	All analyses will be conducted on an intention to treat basis using linear regression models .
-METHODS	Health economic modelling will be applied to estimate the potential cost-effectiveness of mindfulness training and total joint arthroplasty .
-BACKGROUND	Australian New Zealand Clinical Trials Registry ( ANZCTRN12611001184965 ) .
-BACKGROUND	Date of registration ; 15th November 2011 .
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-###25418079
-OBJECTIVE	The objective of this study was to evaluate the effectiveness of nystatin and Biotne ( ) mouthwash Oral Rinse for controlling Candida in total laryngectomy ( TL ) patients with a tracheosophageal voice prosthesis ( TEP ) because Biotne ( ) mouthwash Oral Rinse is a less costly alternative to nystatin and requires less adherence time .
-METHODS	Randomized , unblinded , crossover trial .
-METHODS	Twenty-one TL patients were randomized to receive nystatin followed by Biotne ( ) mouthwash Oral Rinse , or the reverse order , after a basic oral-care phase ( i.e. , brushing teeth , cleaning dentures ) .
-METHODS	A Provox ( ) 2 , 22.5 French TEP , which is an indwelling silicone voice prosthesis , was placed at the beginning of each phase .
-METHODS	Patients were provided with oral care instructions at randomization and medication-specific instructions with each treatment 's initiation .
-METHODS	TEPs were processed and evaluated for Candida growth as colony-forming units ( CFUs ) .
-METHODS	Wilcoxon signed-rank tests were used for comparisons between treatments .
-RESULTS	Fifteen patients were available for comparisons of Candida counts ( 6 received nystatin ; 9 received Biotne ( ) mouthwash first ) .
-RESULTS	Overall , the median log10 ( CFUs ) remained high regardless of treatment ( no medication : 8.9 ; nystatin : 8.7 ; Biotne ( ) mouthwash : 8.4 ) .
-RESULTS	However , the median counts for both nystatin and Biotne ( ) mouthwash Oral Rinse were lower than those for no medication ( difference [ ] : -0.9 and -0.3 , respectively ) , although only nystatin was significantly lower ( P = 0.02 ) .
-RESULTS	There was no significant difference between the two treatments ( P = 0.22 ) .
-RESULTS	Overall , median medication-adherence was high ( 97 % ) , and Biotne ( ) mouthwash adherence was significantly higher than that of nystatin ( : 7.6 % ; P = 0.03 ) .
-CONCLUSIONS	Nystatin and Biotne ( ) mouthwash Oral Rinse had similar CFU levels , with nystatin showing a significant improvement over usual oral care .
-CONCLUSIONS	Biotne ( ) mouthwash is a less costly alternative to nystatin , with a less complex treatment protocol that might make it preferable to patients and clinicians .
-METHODS	1b
-
-###25759551
-OBJECTIVE	To compare the tolerability of magnifying narrow band imaging endoscopy for esophageal cancer screening with that of lugol chromoendoscopy .
-METHODS	We prospectively enrolled and analyzed 51 patients who were at high risk for esophageal cancer .
-METHODS	All patients were divided into two groups : a magnifying narrow band imaging group , and a lugol chromoendoscopy group , for comparison of adverse symptoms .
-METHODS	Esophageal cancer screening was performed on withdrawal of the endoscope .
-METHODS	The primary endpoint was a score on a visual analogue scale for heartburn after the examination .
-METHODS	The secondary endpoints were scale scores for retrosternal pain and dyspnea after the examinations , change in vital signs , total procedure time , and esophageal observation time .
-RESULTS	The scores for heartburn and retrosternal pain in the magnifying narrow band imaging group were significantly better than those in the lugol chromoendoscopy group ( P = 0.004 , 0.024 , respectively , ANOVA for repeated measures ) .
-RESULTS	The increase in heart rate after the procedure was significantly greater in the lugol chromoendoscopy group .
-RESULTS	There was no significant difference between the two groups with respect to other vital sign .
-RESULTS	The total procedure time and esophageal observation time in the magnifying narrow band imaging group were significantly shorter than those in the lugol chromoendoscopy group ( 450 116 vs 565 174 , P = 0.004 , 44 26 vs 151 72 , P < 0.001 , respectively ) .
-CONCLUSIONS	Magnifying narrow band imaging endoscopy reduced the adverse symptoms compared with lugol chromoendoscopy .
-CONCLUSIONS	Narrow band imaging endoscopy is useful and suitable for esophageal cancer screening periodically .
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-###24451221
-BACKGROUND	As traditional methods have become increasingly difficult , the Internet offers a mechanism for conducting survey research quickly and efficiently .
-BACKGROUND	However , the validity of this research depends on the ability of respondents to accurately report health status .
-BACKGROUND	We used a large Internet-based inflammatory bowel disease ( IBD ) cohort to validate self-reported IBD against physician reports .
-METHODS	Between June 22 , 2012 , and April 01 , 2013 , all participants of CCFA Partners ( n = 6681 ) were invited to participate , and 450 were selected by random stratified sampling .
-METHODS	We sent physicians a survey to confirm IBD diagnosis and characteristics .
-METHODS	We used descriptive statistics to compare data .
-RESULTS	A total of 4423 participants ( 66 % ) indicated interest .
-RESULTS	Of 450 selected , 261 ( 58 % ) consented , and physician reports were obtained for 184 ( 71 % ) .
-RESULTS	Physicians confirmed IBD status in 178 ( 97 % ) and type in 171 ( 97 % of confirmed ) .
-RESULTS	The matching between patient and physician reports for Crohn 's disease ( CD ) was 82 % for disease location , 89 % for the presence of perianal disease , and 46 % for disease behavior .
-RESULTS	For ulcerative colitis ( UC ) , disease location matched 54 % of the time .
-RESULTS	Physician reports confirmed the status of ever having bowel surgery for 97 % of CD and 94 % for UC and confirmed current pouch or ostomy in 84 % of CD and 81 % of UC .
-CONCLUSIONS	Self-reported IBD in CCFA Partners is highly accurate , and participants are willing to release medical records for research .
-CONCLUSIONS	Self-reported phenotypic characteristics were less valid .
-CONCLUSIONS	The validity of IBD diagnoses among the participants of CCFA Partners supports the use of this cohort for patient-centered outcome research .
-
-###24781960
-OBJECTIVE	In type 2 diabetes mellitus ( T2DM ) , team management using protocols with regular feedback improves clinical outcomes , although suboptimal self-management and psychological distress remain significant challenges .
-OBJECTIVE	To investigate if frequent contacts through a telephone-based peer support program ( Peer Support , Empowerment , and Remote Communication Linked by Information Technology [ PEARL ] ) would improve cardiometabolic risk and health outcomes by enhancing psychological well-being and self-care in patients receiving integrated care implemented through a web-based multicomponent quality improvement program ( JADE [ Joint Asia Diabetes Evaluation ] ) .
-METHODS	Between 2009 and 2010 , 628 of 2766 Hong Kong Chinese patients with T2DM from 3 publicly funded hospital-based diabetes centers were randomized to the JADE+PEARL ( n = 312 ) or JADE ( n = 316 ) groups , with comprehensive assessment at 0 and 12 months .
-METHODS	Thirty-three motivated patients with well-controlled T2DM received 32 hours of training ( four 8-hour workshops ) to become peer supporters , with 10 patients assigned to each .
-METHODS	Peer supporters called their peers at least 12 times , guided by a checklist .
-METHODS	Changes in hemoglobin A ( 1c ) ( HbA ( 1c ) ) level ( primary ) , proportions of patients with attained treatment targets ( HbA ( 1c ) < 7 % ; blood pressure < 130/80 mm Hg ; low-density lipoprotein cholesterol < 2.6 mmol/L [ to convert to milligrams per deciliter , divide by 0.0256 ] ) ( secondary ) , and other health outcomes at month 12 .
-RESULTS	Both groups had similar baseline characteristics ( mean [ SD ] age , 54.7 [ 9.3 ] years ; 57 % men ; disease duration , 9.4 [ 7.7 ] years ; HbA ( 1c ) level , 8.2 % [ 1.6 % ] ; systolic blood pressure , 136 [ 19 ] mm Hg ; low-density lipoprotein cholesterol level , 2.89 [ 0.82 ] mmol/L ; 17.4 % cardiovascular-renal complications ; and 34.9 % insulin treated ) .
-RESULTS	After a mean ( SD ) follow-up period of 414 ( 55 ) days , 5 patients had died , 144 had at least 1 hospitalization , and 586 had repeated comprehensive assessments .
-RESULTS	On intention-to-treat analysis , both groups had similar reductions in HbA ( 1c ) ( JADE+PEARL , 0.30 % [ 95 % CI , 0.12 % -0.47 % ] , vs JADE , 0.29 % [ 95 % CI , 0.12 % -0.47 % ] [ P = .97 ] ) and improvements in treatment targets and psychological-behavioral measures .
-RESULTS	In the JADE+PEARL group , 90 % of patients maintained contacts with their peer supporters , with a median of 20 calls per patient .
-RESULTS	Most of the discussion items were related to self-management .
-CONCLUSIONS	In patients with T2DM receiving integrated care , peer support did not improve cardiometabolic risks or psychological well-being .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00950716 .
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-###25229983
-OBJECTIVE	Resistance to antibiotics is the major cause of treatment failure of Helicobacter pylori ( HP ) infection .
-OBJECTIVE	The culture-guided triple therapy ( chosen on the basis of a preliminary in-vitro susceptibility test ) might help to increase treatment success in high antibiotic resistance regions .
-OBJECTIVE	The aim of this study was to evaluate the effectiveness of treatment with clarithromycin in patients with clarithromycin-sensitive culture compared with patients treated empirically .
-METHODS	In this prospective and controlled trial , 111 naive HP-positive patients were randomized to receive standard triple therapy omeprazole ( 20mg twice daily ) , amoxicillin ( 1g twice daily ) , and clarithromycin ( 500mg twice daily ) for 10 days ( OAC ) after antimicrobial susceptibility testing if there was no resistance to clarithromycin ( ClariS ) or empirical 10-day OAC for first-line therapy of HP ( ClariNA ) .
-METHODS	Eradication was confirmed using the C-labelled urea breath test 6 weeks after therapy .
-METHODS	Our primary outcome was HP eradication .
-METHODS	Treatment adherence and adverse effects were recorded .
-RESULTS	The effectiveness of eradication by protocol with 10-day OAC therapy in the ClariS was 94 % [ 95 % confidence interval ( CI ) : 0.83-0 .98 ] , which was 22 % higher than ClariNA 72 % ( 95 % CI : 0.58-0 .85 ; P = 0.006 ) .
-RESULTS	The odds ratio of eradication in ClariS was 1.30 ( 95 % CI : 1.10-1 .60 ; P < 0.05 by logistic regression ) and the number needed to treat was 5 ( 95 % CI : 3-13 ) .
-RESULTS	We found no significant difference in the occurrence of adverse effects or in compliance between the two groups .
-CONCLUSIONS	The eradication rate was significantly higher with clarithromycin-based triple therapy for patients with clarithromycin-susceptible HP isolates compared with those for whom no information on the corresponding susceptibility was available ( ClinicalTrials.gov number NCT01486082 ) .
-
-###24955450
-OBJECTIVE	This study was designed to demonstrate the safety and efficacy of esomeprazole combined with flupentixol/melitracen for the treatment of gastroesophageal reflux disease ( GERD ) patients with emotional disorders .
-OBJECTIVE	METHODS Two hundred eighty-nine GERD patients with emotional disorders were divided randomly into two groups : group 1 received esomeprazole only ( monotherapy ) and group 2 received esomeprazole and flupentixol/melitracen ( combination therapy ) .
-OBJECTIVE	The patients ' GERD questionnaire ( GerdQ ) and hospital anxiety and depression ( HAD ) scores were obtained before and after treatment .
-OBJECTIVE	Changes in the scores , rates of symptom remission , and adverse effects were compared between the two groups .
-RESULTS	After 2 weeks of treatment , the average decrease in GerdQ score in the combination group ( 4.04 2.34 ) was significantly greater than that in the monotherapy group ( 3.34 2.74 ; P < 0.05 ) .
-RESULTS	Significant differences between the two groups were also found for changes in HAD anxiety scores ( 5.45 2.41 vs 3.34 2.43 , P < 0.05 ) , depression scores ( 5.47 2.47 vs 3.00 3.28 , P < 0.05 ) , and anxiety-depression scores ( 5.20 2.71 vs 3.60 2.56 , P < 0.05 ) .
-RESULTS	The remission of symptoms ( eructation , abdominal pain , anorexia , and other accompanying symptoms ) in the combination group was significantly better than that in the monotherapy group , and no significant difference in the incidence of adverse events was observed between the two groups .
-CONCLUSIONS	The combination therapy has better efficacy than the monotherapy in improving the symptoms of gastroesophageal reflux in patients with emotional disorders .
-CONCLUSIONS	In addition , this combination treatment is safe , with a low incidence of adverse events .
-
-###25238785
-BACKGROUND	Management of acute sore throat poses a significant burden on UK general practices , with almost 10 % of registered patients attending their GP with sore throat every year .
-BACKGROUND	Nearly half of all patients presenting with acute sore throat are treated with antibiotics , despite their limited effect .
-BACKGROUND	In a recent systematic review we demonstrated that a single dose of steroids reduced the severity and time to resolution of sore throat .
-BACKGROUND	However , all of the trials included looked at the use of steroids alongside antibiotics and only one was in a primary care setting .
-BACKGROUND	This trial aims to assess the efficacy and cost-effectiveness of a single oral dose of corticosteroids on symptoms of sore throat in patients receiving either a delayed antibiotic prescription or no antibiotics at all in UK primary care .
-METHODS	A double-blind , two arm , randomized , placebo controlled trial in adults ( 18 years of age ) presenting to primary care with acute sore throat ( < seven days ) .
-METHODS	Participants are recruited on the day of presentation to their GP practice .
-METHODS	GPs or nurses assess eligibility , record baseline clinical features and obtain a throat swab for bacterial culture .
-METHODS	Participants are being randomized to treatment arms at a ratio of 1:1 .
-METHODS	Treatment arms will be stratified according to whether patients are being given a delayed antibiotic prescription or no antibiotic prescription and by recruiting centre ( Oxford , Bristol or Southampton ) .
-METHODS	Outcome data is being collected at 24 and 48 hours via text message or telephone call , from days 0 to 7 using a patient symptom diary and at one month via a GP notes review .
-CONCLUSIONS	This will be the first randomized controlled trial of oral corticosteroids in adults presenting to primary care with sore throat in the UK , and the first to examine the clinical and cost-effectiveness of oral corticosteroids for the treatment of sore throat in the absence of antibiotics .
-BACKGROUND	This trial is registered with Current Controlled Trials on 26 March 2013 , registration number : ISRCTN17435450 .
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-###25575262
-BACKGROUND	Postoperative infectious complications in patients undergoing pancreatic surgery are a significant cause for morbidity and mortality .
-BACKGROUND	Although synbiotics have beneficial effects on human health , their clinical value in surgical patients remains unclear given a paucity of applicable clinical studies .
-OBJECTIVE	To determine the impact of perioperative synbiotic therapy on postoperative infectious complications , morbidity and mortality in patients undergoing pancreatic surgery for chronic pancreatitis .
-METHODS	A trial was conducted in patients with chronic calcific pancreatitis undergoing Frey 's procedure .
-METHODS	Group A received a specific synbiotic composition , 5 days prior and 10 days after the surgery .
-METHODS	Group B received a placebo .
-METHODS	Primary study endpoint was the occurrence of postoperative infection during the first 30 days .
-METHODS	Secondary outcome measures were mortality , length of hospital stay , days in intensive care unit , and duration of antibiotic therapy .
-METHODS	Using previously accrued data , with of 0.05 and power 80 % , the sample size was calculated as 35 patients for each group with a dropout rate of 10 % .
-RESULTS	Of the 79 patients enrolled , 75 completed the trial [ group A ( n = 39 ) and group B ( n = 36 ) ] .
-RESULTS	The incidence of postoperative infectious complications ( 12.8 % vs 39 % ; P < 0.05 ) , duration of antibiotics therapy ( P < 0.05 ) , and length of hospital stay ( P < 0.05 ) were significantly lower in the synbiotic group .
-CONCLUSIONS	Synbiotics significantly reduce septic complications , hospital stay , and antibiotic requirement in patients undergoing pancreatic surgery for chronic pancreatitis .
-CONCLUSIONS	Furthermore , basic and clinical research would clarify the underlying mechanisms of their therapeutic effect and define the appropriate conditions for use .
-
-###24768221
-BACKGROUND	Minimally invasive plate osteosynthesis for humeral shaft fractures has been described recently , but there are no randomized studies comparing the clinical results for shoulder function between this technique and locking intramedullary nailing .
-METHODS	A prospective randomized study was performed .
-METHODS	Forty-one humeral shaft fractures ( 40 patients ) were randomized to be treated with a minimally invasive plate ( n = 21 ) or a locking intramedullary nail ( n = 19 ) .
-METHODS	Clinical and radiographic outcome assessments were conducted at 1year postoperatively .
-METHODS	Shoulder function was the primary outcome , as measured by the University of California , Los Angeles Shoulder Scale .
-METHODS	Elbow function was measured by the Broberg-Morrey score , and fracture consolidation and complications were the main secondary outcomes .
-RESULTS	At 1year postoperatively , no significant difference was found with regard to shoulder function according to the University of California , Los Angeles scale between the minimally invasive plate and locking intramedullary nail ( 31.4 points vs 31.2 points , P = .98 ) .
-RESULTS	There was also no difference in elbow function ( 94.8 points vs 94.1 points , P = .96 ) .
-RESULTS	Complications were similar between the groups , without significant differences regarding infection ( P > .99 ) , symptomatic shoulder stiffness ( P = .488 ) , and neurapraxia of the lateral cutaneous nerve of the forearm ( P = .475 ) .
-RESULTS	Fracture union was achieved in all but 1 patient ( 2.4 % ) in the intramedullary nail group within 1year after the surgical procedure .
-CONCLUSIONS	There is no significant difference in shoulder function between antegrade intramedullary nailing and minimally invasive plate osteosynthesis for the treatment of displaced humeral shaft fractures , despite the limited power of our study .
-
-###24621126
-BACKGROUND	Exposure to particulate matter ( PM ) air pollution especially derived from traffic is associated with increases in cardiorespiratory morbidity and mortality .
-BACKGROUND	In this study , we evaluated the ability of novel vehicle cabin air inlet filters to reduce diesel exhaust ( DE ) - induced symptoms and markers of inflammation in human subjects .
-METHODS	Thirty healthy subjects participated in a randomized double-blind controlled crossover study where they were exposed to filtered air , unfiltered DE and DE filtered through two selected particle filters , one with and one without active charcoal .
-METHODS	Exposures lasted for one hour .
-METHODS	Symptoms were assessed before and during exposures and lung function was measured before and after each exposure , with inflammation assessed in peripheral blood five hours after exposures .
-METHODS	In parallel , PM were collected from unfiltered and filtered DE and assessed for their capacity to drive damaging oxidation reactions in a cell-free model , or promote inflammation in A549 cells .
-RESULTS	The standard particle filter employed in this study reduced PM10 mass concentrations within the exposure chamber by 46 % , further reduced to 74 % by the inclusion of an active charcoal component .
-RESULTS	In addition use of the active charcoal filter was associated by a 75 % and 50 % reduction in NO2 and hydrocarbon concentrations , respectively .
-RESULTS	As expected , subjects reported more subjective symptoms after exposure to unfiltered DE compared to filtered air , which was significantly reduced by the filter with an active charcoal component .
-RESULTS	There were no significant changes in lung function after exposures .
-RESULTS	Similarly diesel exhaust did not elicit significant increases in any of the inflammatory markers examined in the peripheral blood samples 5hour post-exposure .
-RESULTS	Whilst the filters reduced chamber particle concentrations , the oxidative activity of the particles themselves , did not change following filtration with either filter .
-RESULTS	In contrast , diesel exhaust PM passed through the active charcoal combination filter appeared less inflammatory to A549 cells .
-CONCLUSIONS	A cabin air inlet particle filter including an active charcoal component was highly effective in reducing both DE particulate and gaseous components , with reduced exhaust-induced symptoms in healthy volunteers .
-CONCLUSIONS	These data demonstrate the effectiveness of cabin filters to protect subjects travelling in vehicles from diesel exhaust emissions .
-
-###24636210
-BACKGROUND	Treatment of breast cancer with aromatase inhibitors is associated with damage to bones .
-BACKGROUND	NCIC CTG MA .27 was an open-label , phase 3 , randomised controlled trial in which women with breast cancer were assigned to one of two adjuvant oral aromatase inhibitors-exemestane or anastrozole .
-BACKGROUND	We postulated that exemestane-a mildly androgenic steroid-might have a less detrimental effect on bone than non-steroidal anastrozole .
-BACKGROUND	In this companion study to MA .27 , we compared changes in bone mineral density ( BMD ) in the lumbar spine and total hip between patients treated with exemestane and patients treated with anastrozole .
-METHODS	In MA .27 , postmenopausal women with early stage hormone ( oestrogen ) receptor-positive invasive breast cancer were randomly assigned to exemestane 25 mg versus anastrozole 1 mg , daily .
-METHODS	MA .27 B recruited two groups of women from MA .27 : those with BMD T-scores of -20 or more ( up to 2 SDs below sex-matched , young adult mean ) and those with at least one T-score ( hip or spine ) less than -20 .
-METHODS	Both groups received vitamin D and calcium ; those with baseline T-scores of less than -20 also received bisphosphonates .
-METHODS	The primary endpoints were percent change of BMD at 2 years in lumbar spine and total hip for both groups .
-METHODS	We analysed patients according to which aromatase inhibitor and T-score groups they were allocated to but BMD assessments ceased if patients deviated from protocol .
-METHODS	This study is registered with ClinicalTrials.gov , NCT00354302 .
-RESULTS	Between April 24 , 2006 , and May 30 , 2008 , 300 patients with baseline T-scores of -20 or more were accrued ( 147 allocated exemestane , 153 anastrozole ) ; and 197 patients with baseline T-scores of less than -20 ( 101 exemestane , 96 anastrozole ) .
-RESULTS	For patients with T-scores greater than -20 at baseline , mean change of bone mineral density in the spine at 2 years did not differ significantly between patients taking exemestane and patients taking anastrozole ( -092 % , 95 % CI -235 to 050 vs -239 % , 95 % CI -377 to -101 ; p = 008 ) .
-RESULTS	Respective mean loss in the hip was -193 % ( 95 % CI -293 to -093 ) versus -271 % ( 95 % CI -432 to -111 ; p = 010 ) .
-RESULTS	Likewise for those who started with T-scores of less than -20 , mean change of spine bone mineral density at 2 years did not differ significantly between the exemestane and anastrozole treatment groups ( 211 % , 95 % CI -084 to 506 vs 372 % , 95 % CI 154 to 589 ; p = 026 ) , nor did hip bone mineral density ( 209 % , 95 % CI -145 to 563 vs 00 % , 95 % CI -367 to 366 ; p = 028 ) .
-RESULTS	Patients with baseline T-score of -20 or more taking exemestane had two fragility fractures and two other fractures , those taking anastrozole had three fragility fractures and five other fractures .
-RESULTS	For patients who had baseline T-scores of less than -20 taking exemestane , one had a fragility fracture and four had other fractures , whereas those taking anastrozole had five fragility fractures and one other fracture .
-CONCLUSIONS	Our results demonstrate that adjuvant treatment with aromatase inhibitors can be considered for breast cancer patients who have T-scores less than -20 .
-BACKGROUND	Canadian Cancer Society Research Institute , Pfizer , Canadian Institutes of Health Research .
-
-###24448036
-OBJECTIVE	To determine whether medical student intubation proficiency with a neonatal mannequin differs according to weekly or consecutive day practice sessions during a six-week pediatric clerkship .
-METHODS	From July 2010 through June 2011 , the authors prospectively randomized 110 third-year medical students into three neonatal intubation practice groups : standard ( control ; no practice sessions ) , weekly ( practice once/week for four consecutive weeks ) , or consecutive day ( practice once/day for four consecutive days ) .
-METHODS	At baseline , students performed intubation during individual sessions using a neonatal mannequin ( SimNewB ) .
-METHODS	Two reviewers , blinded to practice group , viewed videotapes of intubations and independently scored students on equipment selection , procedural skill steps , length of intubation attempts ( in seconds ) , and the number of attempts ( up to three ) needed for a successful intubation .
-METHODS	Videotaped individual final assessment intubation sessions during week six were evaluated in the same manner .
-RESULTS	Students in the weekly and consecutive day practice groups performed better at the final assessment on all variables than students in the standard group ( P < .001 ) , but over six weeks , the authors detected no differences between the two distributed practice formats for any outcomes of interest .
-CONCLUSIONS	Practice improved all aspects of neonatal intubation performance , including choosing the correct equipment , properly performing the skill steps , length of time to successful intubation , and success rate , for novice health care providers in a simulation setting .
-CONCLUSIONS	Over six weeks , neither practice format proved superior , but it remains unclear whether one format is superior for learning and skill retention over the long term or in actual practice .
-
-###24300595
-BACKGROUND	Obesity and reduced muscle strength are associated with increased blood pressure ( BP ) .
-BACKGROUND	We examined the impact of milk proteins and combined exercise training ( CET ) on BP , arterial function , and muscle strength ( one-repetition maximum ( 1-RM ) ) .
-METHODS	Thirty-three obese sedentary women ( age = 30 1 years ; body mass index = 35.2 0.9 kg/m ( 2 ) ; systolic BP ( SBP ) = 129 2 mm Hg ) were randomized to control carbohydrate ( n = 11 ) , whey ( n = 11 ) , and casein ( n = 11 ) supplementation for 4 weeks .
-METHODS	All participants performed moderate-intensity CET 3 days/week .
-METHODS	Brachial and aortic SBP , augmentation index adjusted for 75 beats/minute ( AIx@75 ) , arterial stiffness ( brachial-ankle pulse wave velocity ( baPWV ) ) , and 1-RM were measured before and after the interventions .
-RESULTS	There were significant ( P < 0.05 ) time-by-group interactions for brachial SBP ( bSBP ) , aortic SBP ( aSBP ) , AIx@75, and baPWV .
-RESULTS	Whey and casein supplementation significantly ( P < 0.05 ) decreased bSBP ( approximately 5mm Hg for both ) , aSBP ( approximately 7 mm Hg and approximately 6mm Hg , respectively ) , AIx@75 ( approximately 9.2 % and approximately 8.1 % , respectively ) and baPWV ( approximately 57 cm/s and approximately 53 cm/s , respectively ) compared with no changes in the control group .
-RESULTS	Upper - ( approximately 22.2 % ) and lower-body 1-RM ( approximately 44.0 % ) increased similarly in all groups .
-RESULTS	Changes in arterial function and 1-RM were not correlated .
-CONCLUSIONS	Milk protein supplementation with CET reduced SBP , wave reflection , and arterial stiffness in young obese women with prehypertension and hypertension .
-CONCLUSIONS	Because CET did not affect arterial function , milk proteins may have an antihypertensive effect by improving arterial function , as shown by reduced AIx@75 and baPWV .
-CONCLUSIONS	Muscle strength improvements after CET did not affect BP and arterial function .
-BACKGROUND	ClinicalTrial.gov Registration NCT01830946 .
-
-###24808482
-BACKGROUND	Management of moderate acute malnutrition ( MAM ) is , currently , focused on food supplementation approaches .
-BACKGROUND	However , the sustainability of these strategies remains weak in low - and middle-income countries .
-BACKGROUND	In food-secure settings , an educational/behavioral intervention could be an alternative for improving MAM management .
-OBJECTIVE	This study compared the effectiveness of weekly context-appropriate child-centered counseling ( CCC ) , with an improved corn-soy blend [ corn-soy blend with added micronutrients ( CSB + + ) ] or a locally produced ready-to-use supplementary food ( RUSF ) , in treating MAM through first-line rural health services .
-METHODS	We used a cluster randomized controlled trial design with 3 arms , involving 18 rural health centers ( 6 by arm ) and children aged 6-24 mo with uncomplicated MAM .
-METHODS	In the first arm ( CCC ) , trained health workers provided weekly personalized counseling to caretakers .
-METHODS	In the 2 other arms , children received weekly either 455 g CSB + + or 350 g locally produced soy-based RUSF .
-METHODS	Both food supplements provided 250 kcal/d .
-RESULTS	The recovery rate after 3 mo of treatment was significantly lower with CCC ( 57.8 % ) than with CSB + + ( 74.5 % ) and RUSF ( 74.2 % ) ( P < 0001 ) .
-RESULTS	Mothers ' attendance at health facilities was also substantially lower in the CCC arm ( P < 0001 ) ; this arm had a high defaulter rate ( P < 0.003 ) .
-RESULTS	When the analysis was adjusted for attendance , we did not find a significant difference between the 3 arms , with incidence rate ratios of 1.14 ( 95 % CI : 0.99 , 1.31 ) and 1.13 ( 95 % CI : 0.98 , 1.30 ) for the CSB + + and RUSF arms , respectively , compared with the CCC arm .
-CONCLUSIONS	Whereas supplement-based treatment of MAM was found to be more effective than the provision of CCC , we hypothesize that appropriate and specific nutrition counseling centered on children 's needs , through primary health facilities , might be an alternative strategy for MAM treatment in rural food-secure areas , provided that attendance at counseling sessions by the caregiver is ensured .
-CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01115647 .
-
-###25504506
-OBJECTIVE	To evaluate the efficacy and safety of arsenic trioxide transarterial chemoembolization and intravenous administration in unresectable hepatocellular carcinoma with lung metastasis .
-METHODS	A single-blind , two-parallel group , randomized trial was conducted at three medical centers ( Guangzhou , China ) , including patients with both biopsy-confirmed hepatocellular carcinoma and lung metastasis .
-METHODS	The experimental group received arsenic trioxide transarterial chemoembolization and intravenous administration of arsenic trioxide , while the control group only received arsenic trioxide transarterial chemoembolization .
-METHODS	We compared overall survival ( OS ) , time to progression ( TTP ) , disease control rate ( DCR ) , and objective response rate ( ORR ) between the groups .
-RESULTS	Between April 2013 and June 2014 , 139 patients received the allocated intervention , 70 of whom were in the experimental group and 69 of whom were in the control group .
-RESULTS	No patient was lost to follow-up .
-RESULTS	The median OS was 7.3 ( 95 % CI = 6.8-7 .8 ) months in the experimental group and 2.9 ( 95 % CI = 2.6-3 .1 ) months in the control group ( P < 0.001 ) .
-RESULTS	The median TTP was 2.7 ( 95 % CI = 1.9-3 .3 ) months in the experimental group and 1.2 ( 95 % CI = 1.0-1 .9 ) months in the control group ( P = 0.023 ) .
-RESULTS	In the experimental group , the DCR was 72.85 % and the ORR was 7.14 % , while in the control group , the DCR was 7.24 % and the ORR was 0.00 % .
-RESULTS	DCR and ORR differed significantly between the two groups ( P < 0.001 and P = 0.024 , respectively ) .
-CONCLUSIONS	Arsenic trioxide transarterial chemoembolization and intravenous administration were safe and effective in unresectable hepatocellular carcinoma with lung metastasis .
-
-###25604219
-OBJECTIVE	To evaluate the efficacy and safety of dexmedetomidine for post-operative elder patients on mechanical ventilation ( MV ) .
-METHODS	For this randomized controlled trial , 108 cases of post-operative patients on MV were enrolled and assigned into either dexmedetomidine group ( n = 54 ) or propofol group ( n = 54 ) for sedation .
-METHODS	And propofol was used for rescue .
-METHODS	The dose of sedation was regulated by Ramsay score for maintaining a sedative score of 3-4 .
-METHODS	In both groups , fentanyl was provided intravenously continually for analgesia .
-METHODS	The amount of fentanyl was adjusted according to the numerical rating scale ( NRS ) score for maintaining an analgesic score of 0-3 .
-METHODS	The average Ramsay score , the frequency of propofol , the highest score of NRS , the total dosage of fentanyl and recovery time were compared .
-METHODS	Additional outcomes included duration of mechanical ventilation and intensive care unit ( ICU ) length .
-METHODS	And the incidence of delirium and cardiovascular adverse events were compared for two groups .
-RESULTS	No significant inter-group difference existed in the effectiveness of sedation .
-RESULTS	Compare with propofol group , the highest score of NRS decreased ( 1.8 1.12 vs 3.1 1.24 , P < 0.05 ) , the total dosage of fentanyl significantly decreased ( 427.6 14.1 vs 658.4 27.3 g , P < 0.05 ) and recovery time became significantly shortened ( 0.3 0.02 h vs 1.1 0.3 h , P < 0.05 ) in dexmedetomidine group .
-RESULTS	Median duration of mechanical ventilation in dexmedetomidine group ( 21.0 h , 95 % CI : 18.6-21 .4 h ) was significantly shorter than that in propofol group ( 28.0 h , 95 % CI : 25.6-30 .4 h ) ( P < 0.05 ) .
-RESULTS	No inter-group differences existed in the ICU length of stay and the incidence of delirium .
-RESULTS	Two cases in dexmedetomidine group developed bradycardia while hypotension occurred in two cases of propofol group .
-CONCLUSIONS	Sedative effects of dexmedetomidine are safe and effective for post-operative elder patients on MV .
-CONCLUSIONS	And it offers a better efficacy of analgesia and shorter durations of MV and recovery time .
-CONCLUSIONS	But dexmedetomidine had no significant influence on the ICU length of stay or the incidence of delirium .
-
-###25327884
-OBJECTIVE	Similarly to a wrestling match , upper-body intermittent sprint performance ( UBISP ) test elicits severe acidosis .
-OBJECTIVE	This study aimed to determine whether sodium citrate ( CIT ) ingestion would help to better maintain peak power ( PP ) and mean power ( MP ) output across four consecutive UBISP tests simulating wrestling matches of a competition-day .
-METHODS	In a double-blind , counterbalanced , crossover manner , 11 trained wrestlers ingested either placebo ( PLC ) or CIT ( 900 mg kg ( -1 ) ) within a 17-h supplementation period .
-METHODS	Thereafter they completed four ( T1-T4 ) 6-min UBISP tests interspersed with 30-min recovery periods .
-RESULTS	Compared with PLC , CIT supplementation resulted in a persistent increase ( P < 0.05 ) in blood HCO3 ( - ) concentration and pH : pre-T1 25.6 % and 0.08 units , post-T4 39.1 % and 0.14 units , respectively .
-RESULTS	Post-T1 blood lactate concentration in CIT ( 16.1 3.8 mmol L ( -1 ) ) was higher ( P = 0.037 ) than that in PLC ( 13.7 2.3 mmol L ( -1 ) ) .
-RESULTS	Decrease in plasma volume across the supplementation period and UBISP tests was greater ( P = 0.03 ) in PLC ( -6.91 4.37 % ) than in CIT ( -1.51 4.34 % ) .
-RESULTS	There was an overall decrease ( P = 0.028 ) in ratings of perceived exertion in CIT compared with PLC , but no between-trial difference ( P > 0.05 ) in PP or MP in any UBISP test occurred .
-CONCLUSIONS	In trained wrestlers , CIT ingestion induces alkalosis , counteracts reduction in plasma volume , increases post-test blood lactate concentration and reduces perceived exertion , but does not improve PP or MP attained in consecutive UBISP tests simulating four wrestling matches of a competition-day .
-
-###24679060
-BACKGROUND	In short-term randomized trials ( duration , 1 to 2 years ) , bariatric surgery has been associated with improvement in type 2 diabetes mellitus .
-METHODS	We assessed outcomes 3 years after the randomization of 150 obese patients with uncontrolled type 2 diabetes to receive either intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy .
-METHODS	The primary end point was a glycated hemoglobin level of 6.0 % or less .
-RESULTS	The mean ( SD ) age of the patients at baseline was 488 years , 68 % were women , the mean baseline glycated hemoglobin level was 9.31.5 % , and the mean baseline body-mass index ( the weight in kilograms divided by the square of the height in meters ) was 36.03.5 .
-RESULTS	A total of 91 % of the patients completed 36 months of follow-up .
-RESULTS	At 3 years , the criterion for the primary end point was met by 5 % of the patients in the medical-therapy group , as compared with 38 % of those in the gastric-bypass group ( P < 0.001 ) and 24 % of those in the sleeve-gastrectomy group ( P = 0.01 ) .
-RESULTS	The use of glucose-lowering medications , including insulin , was lower in the surgical groups than in the medical-therapy group .
-RESULTS	Patients in the surgical groups had greater mean percentage reductions in weight from baseline , with reductions of 24.59.1 % in the gastric-bypass group and 21.18.9 % in the sleeve-gastrectomy group , as compared with a reduction of 4.28.3 % in the medical-therapy group ( P < 0.001 for both comparisons ) .
-RESULTS	Quality-of-life measures were significantly better in the two surgical groups than in the medical-therapy group .
-RESULTS	There were no major late surgical complications .
-CONCLUSIONS	Among obese patients with uncontrolled type 2 diabetes , 3 years of intensive medical therapy plus bariatric surgery resulted in glycemic control in significantly more patients than did medical therapy alone .
-CONCLUSIONS	Analyses of secondary end points , including body weight , use of glucose-lowering medications , and quality of life , also showed favorable results at 3 years in the surgical groups , as compared with the group receiving medical therapy alone .
-CONCLUSIONS	( Funded by Ethicon and others ; STAMPEDE ClinicalTrials.gov number , NCT00432809 . )
-
-###24355576
-OBJECTIVE	The aims of the study were to evaluate the long-term effects of a home-based smoking prevention program ` Smoke-free Kids ' during preadolescence on smoking initiation during adolescence and to test the potential moderating role of parental smoking , socioeconomic status , and asthma .
-METHODS	In 2008 , 1478 9-11year old children and their mothers were recruited from 418 elementary schools in the Netherlands .
-METHODS	An independent statistician randomly allocated schools to one of the two conditions using a 1:1 ratio ( single blind ) : 728 children in the intervention and 750 in the control condition .
-METHODS	The intervention condition received five activity modules , including a communication sheet for mothers , by mail at four-week intervals and one booster module one year after baseline .
-METHODS	The control condition received a fact-based intervention only .
-METHODS	Intention-to-treat analysis was performed on 1398 non-smoking children at baseline .
-RESULTS	In the intervention 10.8 % of the children started smoking compared to 12 % in the control condition .
-RESULTS	This difference was non-significant ( odds ratio = 0.90 , 95 % confidence interval = 0.63-1 .27 ) .
-RESULTS	No moderating effects were found .
-CONCLUSIONS	No effects on smoking initiation after 36months were found .
-CONCLUSIONS	Perhaps , the program was implemented with children that were too young .
-CONCLUSIONS	Programs closer to the age of smoking onset should be tested .
-
-###24742508
-OBJECTIVE	To investigate the influence of normal saline nasal irrigation with different temperature on allergic rhinitis ( AR ) and to confirm the appropriate temperature of nasal irrigation .
-METHODS	Sixty patients with AR were randomly divided into 3 groups ( according to random number table ) and received 15 C , 25 C or 40 C normal saline nasal irrigation respectively , and 20 healthy controls received no treatment .
-METHODS	Visual analogue scale ( VAS ) was used to assess the symptoms among the control group and the various intervention groups and the enzyme linked immunosorbent assay ( ELISA ) was applied to detect the contents of histamine , leukotriene C4 ( LTC4 ) , house dust mite D1 specific IGE ( sIGE ) and eosinophil cationic protein ( ECP ) among the control group and the various intervention groups .
-METHODS	GraphPad Prism 5 software was used to analyze the data .
-RESULTS	There was no statistical difference between 15 C normal saline nasal irrigation group and 25 C normal saline nasal irrigation group .
-RESULTS	Pre-intervention and post intervention whether is VAS scores of rhinorrhea , sneezing , nasal obstruction and nasal pruritis or in contents of histamine , LTC4 , sIgE and ECP showed no difference ( all P > 0.05 ) .
-RESULTS	However , the symptoms of ( sneezing VAS score : 3.765 0.291 ; nasal obstruction VAS score : 3.529 0.365 ) .
-RESULTS	The difference was significant ( t = 4.678 , P < 0.001 ; t = 3.901 , P < 0.01 ) .
-RESULTS	The contents of histamine [ ( 21.78 0.62 ) ng/ml ] and LTC4 ( 17.43 0.67 ng/ml ) were also decreased after intervention of 40 C normal saline nasal irrigation [ histamine content : ( 18.82 0.52 ) ng/ml ; LTC4 content : ( 13.14 0.59 ) ng/ml ] .
-RESULTS	The difference was significant ( t = 3.632 , P < 0.01 ; t = 4.79 , P < 0.001 ) .
-RESULTS	Nonetheless , there were no statistical differences in VAS scores of rhinorrhea ( t = 2.02 , P = 0.051 ) and nasal pruritis ( t = 1.984 , P = 0.056 ) and in contents of sIgE ( t = 1.891 , P = 0.066 ) and ECP ( t = 2.021 , P = 0.05 ) .
-RESULTS	There were statistical differences between the 40 C group and the 25 C group normal saline nasal irrigation group in symptoms of sneezing ( t = 2.060 , P = 0.048 ) and nasal obstruction ( t = 2.1053 , P = 0.048 ) .
-RESULTS	and inflammatory factors of histamine ( t = 2.078 , P = 0.045 ) and LTC4 ( t = 2.149 , P = 0.038 ) .
-RESULTS	In symptoms of rhinorrhea and nasal pruritis and local production of sIgE and ECP , there was no statistical difference ( all P > 0.05 ) .
-CONCLUSIONS	40 C normal saline nasal irrigation can improve the symptoms of sneezing and nasal obstruction and can alleviate the local levels of inflammatory factors like histamine and LTC4 in AR patients , and is the appropriate irrigation temperature .
-
-###25431430
-BACKGROUND	Individual-based cognitive-behavioural therapy ( CBT ) is in short supply and expensive .
-OBJECTIVE	The aim of this randomised controlled trial ( RCT ) was to compare mindfulness-based group therapy with treatment as usual ( primarily individual-based CBT ) in primary care patients with depressive , anxiety or stress and adjustment disorders .
-METHODS	This 8-week RCT ( ClinicalTrials.gov ID : NCT01476371 ) was conducted during spring 2012 at 16 general practices in Southern Sweden .
-METHODS	Eligible patients ( aged 20-64 years ) scored 10 on the Patient Health Questionnaire-9 , 7 on the Hospital Anxiety and Depression Scale or 13-34 on the Montgomery-sberg Depression Rating Scale ( self-rated version ) .
-METHODS	The power calculations were based on non-inferiority .
-METHODS	In total , 215 patients were randomised .
-METHODS	Ordinal mixed models were used for the analysis .
-RESULTS	For all scales and in both groups , the scores decreased significantly .
-RESULTS	There were no significant differences between the mindfulness and control groups .
-CONCLUSIONS	Mindfulness-based group therapy was non-inferior to treatment as usual for patients with depressive , anxiety or stress and adjustment disorders .
-
-###25244977
-OBJECTIVE	To determine if a new , single-sample device ( ESwab ; Copan Diagnostics , Inc ) can simplify the traditional multi-sample approach to specimen collection in infectious keratitis .
-METHODS	Prospective , diagnostic test evaluation .
-METHODS	In this institutional study , patients with suspected infectious keratitis meeting traditional criteria for diagnostic corneal specimen collection and culture were randomized to the order of first specimen collection method : ESwab or a sample directly plated for growth on chocolate agar .
-METHODS	This was followed by standard samples for blood agar , Gram stain , Sabouraud agar , thioglycolate broth , and brain heart infusion broth in all cases .
-METHODS	The specimens collected using the 2 approaches were analyzed separately by the laboratory in a masked fashion .
-METHODS	The main outcome measure was positive growth on cultured media .
-RESULTS	Eighty-one eyes from 80 consecutive patients were sampled .
-RESULTS	Culture positivity rate for the multi-sample method and ESwab was 70 % and 69 % , respectively , with a 75 % agreement rate .
-RESULTS	ESwab sensitivity was 84 % ( 95 % confidence interval [ CI ] : 72 % -93 % ) , with a specificity of 67 % ( 95 % CI : 45 % -84 % ) .
-RESULTS	Positive and negative predictive values of the ESwab were 86 % ( 95 % CI : 74 % -94 % ) and 64 % ( 95 % CI : 43 % -82 % ) , respectively .
-RESULTS	There was no difference in positive culture reports with respect to the order of specimen collection technique used .
-CONCLUSIONS	The single-sample ESwab method is a more accessible and less cumbersome approach to corneal culturing for ophthalmologists , particularly those in the community setting who do not have access to the full set of traditional culture materials .
-CONCLUSIONS	Culture results using this single-sample approach were comparable to the multi-sample method .
-
-###24872261
-BACKGROUND	The management of open tibia fractures remains controversial despite increase in its incidence .
-BACKGROUND	Some surgeons avoid internal fixations for fear of infection while others have demonstrated its superiority .
-BACKGROUND	Identifying an optimal management modality is of utmost benefit to our patients .
-BACKGROUND	Study objectives were to compare the rate of infection and mean duration to healing in the management of open tibia fractures using unreamed interlocking intramedullary nail and external fixation .
-METHODS	The study was an interventional study comparing two known standard methods of managing open tibia fractures conducted in the orthopaedic and trauma department of a tertiary health institution in South west , Nigeria .
-METHODS	Forty patients who presented with open tibia fractures were allocated alternately into primary interlocking nailing group and external fixation group .
-METHODS	Follow-up was for two years .
-RESULTS	Incidences of deep wound infection in both groups were 35 % ( external fixation ) and 11.1 % ( interlocking nailing ) respectively .
-RESULTS	The relative risk of developing infection in external fixation group was 3.2 .
-RESULTS	Mean duration to union was 14.8 weeks and 14.4 weeks in the external fixation and interlocking nailing groups respectively , difference in mean was not statistically significant , ( t = 0.133 , p = 0.895 ) .
-CONCLUSIONS	The risk of wound infection was observed to be higher in this study with the use of external fixation in the management of open tibia fractures compared with unreamed interlocking intramedullary nail .
-
-###24534120
-OBJECTIVE	To determine if concomitant CT-guided biopsy and percutaneous fiducial seed placement in the lung can be performed in a selective patient population without increased complication or decreased success rates compared to either procedure alone .
-METHODS	An IRB approved retrospective analysis of 285 consecutive patients that underwent CT-guided placement of fiducial seeds in the lung alone ( N = 63 ) , with concomitant core biopsy ( N = 53 ) or only core biopsy ( N = 169 ) was performed .
-METHODS	Variables compared included : patient demographics , lesion size , depth from pleura , needle size , number of passes through pleura , number and size of core biopsies , number of seeds placed and technical success rates .
-METHODS	Statistical analysis was performed using univariate and multivariate pair-wise comparisons .
-RESULTS	A pathologic diagnosis of malignancy was confirmed in all cases undergoing seed placement alone and seed placement with concurrent biopsy , and in 144 of the biopsy alone lesions .
-RESULTS	On univariate analysis , major complication rates were similar for all three groups as were lesion size , depth , number of pleural passes , and technical success .
-RESULTS	Pair-wise comparisons of the remaining variables demonstrated a significant younger age and smaller needle size in the biopsy only group , and less minor complications in the fiducial only group .
-RESULTS	Overall there were 80/285 ( 28.1 % ) minor and 29/285 ( 10.2 % ) major complications .
-RESULTS	All major complications leading to admission consisted of either pneumothorax or hemothorax , while minor complications included asymptomatic stable or resolving pneumothoraces , transient hemoptysis or small hemothoraces .
-CONCLUSIONS	A combined procedure of percutaneous pulmonary core biopsy and stereotactic seed placement can be performed without additional risk of a major complication when compared to performing these separately .
-
-###25161823
-BACKGROUND	The day-to-day causes of stress are called daily hassles .
-BACKGROUND	Daily hassles are correlated with ill health .
-BACKGROUND	Biofeedback ( BF ) is one of the tools used for acquiring stress-coping skills .
-BACKGROUND	However , the anatomical correlates of the effects of BF with long training periods remain unclear .
-BACKGROUND	In this study , we aimed to investigate this .
-METHODS	PARTICIPANTS WERE ASSIGNED RANDOMLY TO TWO GROUPS : the intervention group and the control group .
-METHODS	Participants in the intervention group performed a biofeedback training ( BFT ) task ( a combination task for heart rate and cerebral blood flow control ) every day , for about 5 min once a day .
-METHODS	The study outcomes included MRI , psychological tests ( e.g. , Positive and Negative Affect Schedule , Center for Epidemiologic Studies Depression Scale , and Brief Job Stress Questionnaire ) , and a stress marker ( salivary cortisol levels ) before ( day 0 ) and after ( day 28 ) the intervention .
-RESULTS	We observed significant improvements in the psychological test scores and salivary cortisol levels in the intervention group compared to the control group .
-RESULTS	Furthermore , voxel-based morphometric analysis revealed that compared to the control group , the intervention group had significantly increased regional gray matter ( GM ) volume in the right lateral orbitofrontal cortex , which is an anatomical cluster that includes mainly the left hippocampus , and the left subgenual anterior cingulate cortex .
-RESULTS	The GM regions are associated with the stress response , and , in general , these regions seem to be the most sensitive to the detrimental effects of stress .
-CONCLUSIONS	Our findings suggest that our BFT is effective against the GM structures vulnerable to stress .
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-###26122282
-BACKGROUND	Recent reports have questioned the adequacy of self-report measures of dietary intake as the basis for scientific conclusions regarding the associations of dietary intake and health , and reports have recommended the development and evaluation of better methods for the assessment of dietary intake in free-living individuals .
-BACKGROUND	We developed a procedure that used pre - and post-meal digital photographs in combination with dietary recalls ( DP+R ) to assess energy intake during ad libitum eating in a cafeteria setting .
-OBJECTIVE	To compare mean daily energy intake of overweight and obese young adults assessed by a DP+R method with mean total daily energy expenditure assessed by doubly labeled water ( TDEE ( DLW ) ) .
-METHODS	Energy intake was assessed using the DP+R method in 91 overweight and obese young adults ( age = 22.93.2 years , body mass index [ BMI ; calculated as kg/m ( 2 ) ] = 31.25.6 , female = 49 % ) over 7 days of ad libitum eating in a university cafeteria .
-METHODS	Foods consumed outside the cafeteria ( ie , snacks , non-cafeteria meals ) were assessed using multiple-pass recall procedures , using food models and standardized , neutral probing questions .
-METHODS	TDEE ( DLW ) was assessed in all participants over the 14-day period .
-RESULTS	The mean energy intakes estimated by DP+R and TDEE ( DLW ) were not significantly different ( DP+R = 2912661 kcal/d ; TDEE ( DLW ) = 2849748 kcal/d , P = 0.42 ) .
-RESULTS	The DP+R method overestimated TDEE ( DLW ) by 63750 kcal/d ( 6.828 % ) .
-CONCLUSIONS	Results suggest that the DP+R method provides estimates of energy intake comparable to those obtained by TDEE ( DLW ) .
-
-###25468576
-OBJECTIVE	To investigate the onset and analgesic effect of adding dexmedetomidine to levobupivacaine for caudal block in young children .
-METHODS	Randomized , prospective , double-blind study .
-METHODS	Women and Children Medical Center and university hospital .
-METHODS	Two hundred twelve children , American Society of Anesthesiologists physical status I or II , aged between 1 and 3 years and weighing between 8 and 18 kg , who were scheduled for elective inguinal hernia repair or hydrocele .
-METHODS	Children were randomly allocated , using a computer-generated sequence of numbers , into 1 of 3 groups : caudal 0.25 % levobupivacaine ( Group L ( 0.25 ) ) , caudal 0.20 % levobupivacaine ( Group L ( 0.20 ) ) , or caudal 0.20 % levobupivacaine plus 2 g/kg dexmedetomidine ( Group LD ) .
-RESULTS	The primary end point of the study was the onset time of caudal levobupivacaine in children .
-RESULTS	The secondary end points of the study were the duration of analgesia and the degree of motor block in children .
-RESULTS	The 50 % and 95 % effective onset time ( 95 % confidence interval ) values of levobupivacaine were 8.19 minutes ( 7.30-9 .08 ) and 11.17 minutes ( 9.44-12 .91 ) in Group L ( 0.25 ) , 10.16 minutes ( 8.90-11 .41 ) and 15.85 minutes ( 13.14-18 .57 ) in Group L ( 0.20 ) , and 9.91 minutes ( 8.55-11 .28 ) and 16.39 minutes ( 13.32-19 .46 ) in Group LD , respectively .
-RESULTS	The mean durations of analgesia in these children were 7.23 , 5.84 , and 19.6 hours in Groups L ( 0.25 ) , L ( 0.20 ) , and LD , respectively .
-RESULTS	There were no significant differences in postoperative residual motor block among the 3 groups .
-CONCLUSIONS	Dexmedetomidine added to levobupivacaine does not have a significant effect on the onset time ; however , it prolongs the duration of analgesia during caudal block in children .
-
-###25064291
-OBJECTIVE	This study 's objective was to investigate whether use of an electronic dietary recording system improves nutrition knowledge , eating attitudes and habitual physical activity levels compared to use of a food diary and no self-monitoring .
-METHODS	Sixty adults aged 20-60 with a body mass index 25 were recruited and randomly assigned to one of three groups : a group using an electronic system ( EG ) , a group using a food diary ( FD ) and a control group using nothing ( CG ) to record food intake .
-METHODS	All participants took part in three 60-90 nutrition seminars and completed three questionnaires on general nutrition knowledge , habitual physical activity levels and eating attitudes at the beginning and end of the 12-week study .
-METHODS	The pre - and post-test scores for each questionnaire were analysed using a paired sample t-test .
-RESULTS	Significant improvements in the domain of ` dietary recommendations ' were found in the EG ( p = 0.009 ) and FD groups ( p = 0.046 ) .
-RESULTS	Great improvements were found in ` sources of nutrients ' , ` choosing everyday foods ' and ` diet-disease relationships ' in EG and FD groups .
-RESULTS	EG group showed greater improvement in the work index and sport index .
-CONCLUSIONS	An electronic dietary recording system may improve eating and exercise behaviour in a self-monitoring process .
-
-###25004917
-OBJECTIVE	To investigate whether an early rehabilitation intervention initiated during acute admission for exacerbations of chronic respiratory disease reduces the risk of readmission over 12 months and ameliorates the negative effects of the episode on physical performance and health status .
-METHODS	Prospective , randomised controlled trial .
-METHODS	An acute cardiorespiratory unit in a teaching hospital and an acute medical unit in an affiliated teaching district general hospital , United Kingdom .
-METHODS	389 patients aged between 45 and 93 who within 48 hours of admission to hospital with an exacerbation of chronic respiratory disease were randomised to an early rehabilitation intervention ( n = 196 ) or to usual care ( n = 193 ) .
-METHODS	The primary outcome was readmission rate at 12 months .
-METHODS	Secondary outcomes included number of hospital days , mortality , physical performance , and health status .
-METHODS	The primary analysis was by intention to treat , with prespecified per protocol analysis as a secondary outcome .
-METHODS	Participants in the early rehabilitation group received a six week intervention , started within 48 hours of admission .
-METHODS	The intervention comprised prescribed , progressive aerobic , resistance , and neuromuscular electrical stimulation training .
-METHODS	Patients also received a self management and education package .
-RESULTS	Of the 389 participants , 320 ( 82 % ) had a primary diagnosis of chronic obstructive pulmonary disease .
-RESULTS	233 ( 60 % ) were readmitted at least once in the following year ( 62 % in the intervention group and 58 % in the control group ) .
-RESULTS	No significant difference between groups was found ( hazard ratio 1.1 , 95 % confidence interval 0.86 to 1.43 , P = 0.4 ) .
-RESULTS	An increase in mortality was seen in the intervention group at one year ( odds ratio 1.74 , 95 % confidence interval 1.05 to 2.88 , P = 0.03 ) .
-RESULTS	Significant recovery in physical performance and health status was seen after discharge in both groups , with no significant difference between groups at one year .
-CONCLUSIONS	Early rehabilitation during hospital admission for chronic respiratory disease did not reduce the risk of subsequent readmission or enhance recovery of physical function following the event over 12 months .
-CONCLUSIONS	Mortality at 12 months was higher in the intervention group .
-CONCLUSIONS	The results suggest that beyond current standard physiotherapy practice , progressive exercise rehabilitation should not be started during the early stages of the acute illness.Trial registration Current Controlled Trials ISRCTN05557928 .
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-###25624387
-BACKGROUND	Pediatric sleep disordered breathing is often caused by hypertrophy of the tonsils and is commonly managed by tonsillectomy .
-BACKGROUND	There is controversy regarding which postsurgical analgesic agents are safe and efficacious .
-METHODS	This prospective randomized clinical trial recruited children who had sleep disordered breathing who were scheduled for tonsillectomy + / - adenoid removal .
-METHODS	Parents were provided with a pulse oximeter to measure oxygen saturation and apnea events the night before and the night after surgery .
-METHODS	Children were randomized to receive acetaminophen with either 0.2-0 .5 mg/kg oral morphine or 10 mg/kg of oral ibuprofen .
-METHODS	The Objective Pain Scale and Faces Scale were used to assess effectiveness on postoperative day 1 and day 5 .
-METHODS	The primary endpoint was changes in respiratory parameters during sleep .
-RESULTS	A total of 91 children aged 1 to 10 years were randomized .
-RESULTS	On the first postoperative night , with respect to oxygen desaturations , 86 % of children did not show improvement in the morphine group , whereas 68 % of ibuprofen patients did show improvement ( 14 % vs 68 % ; P < .01 ) .
-RESULTS	The number of desaturation events increased substantially in the morphine group , with an average increase of 11.17 15.02 desaturation events per hour ( P < .01 ) .
-RESULTS	There were no differences seen in analgesic effectiveness , tonsillar bleeding , or adverse drug reactions .
-CONCLUSIONS	Ibuprofen in combination with acetaminophen provides safe and effective analgesia in children undergoing tonsillectomy .
-CONCLUSIONS	Post-tonsillectomy morphine use should be limited , as it may be unsafe in certain children .
-
-###24531203
-OBJECTIVE	We tested the hypothesis that higher-intensity interval training ( HIIT ) could be deployed into a standard cardiac rehabilitation ( CR ) setting and would result in a greater increase in cardiorespiratory fitness ( ie , peak oxygen uptake , ( ) VO ) versus moderate-intensity continuous training ( MCT ) .
-METHODS	Thirty-nine patients participating in a standard phase 2 CR program were randomized to HIIT or MCT ; 15 patients and 13 patients in the HIIT and MCT groups , respectively , completed CR and baseline and followup cardiopulmonary exercise testing .
-RESULTS	No patients in either study group experienced an event that required hospitalization during or within 3 hours after exercise .
-RESULTS	The changes in resting heart rate and blood pressure at followup testing were similar for both HIIT and MCT .
-RESULTS	( ) VO at ventilatory-derived anaerobic threshold increased more ( P < .05 ) with HIIT ( 3.0 2.8 mLkgmin ) versus MCT ( 0.7 2.2 mLkgmin ) .
-RESULTS	During followup testing , submaximal heart rate at the end of stage 2 of the exercise test was significantly lower within both the HIIT and MCT groups , with no difference noted between groups .
-RESULTS	Peak ( ) VO improved more after CR in patients in HIIT versus MCT ( 3.6 3.1 mLkgmin vs 1.7 1.7 mLkgmin ; P < .05 ) .
-CONCLUSIONS	Among patients with stable coronary heart disease on evidence-based therapy , HIIT was successfully integrated into a standard CR setting and , when compared to MCT , resulted in greater improvement in peak exercise capacity and submaximal endurance .
-
-###24229362
-BACKGROUND	During cancer treatment children have reduced contact with their social network of friends , and have limited participation in education , sports , and leisure activities .
-BACKGROUND	During and following cancer treatment , children describe school related problems , reduced physical fitness , and problems related to interaction with peers .
-METHODS	The RESPECT study is a nationwide population-based prospective , controlled , mixed-methods intervention study looking at children aged 6-18 years newly diagnosed with cancer in eastern Denmark ( n = 120 ) and a matched control group in western Denmark ( n = 120 ) .
-METHODS	RESPECT includes Danish-speaking children diagnosed with cancer and treated at pediatric oncology units in Denmark .
-METHODS	Primary endpoints are the level of educational achievement one year after the cessation of first-line cancer therapy , and the value of VO2max one year after the cessation of first-line cancer therapy .
-METHODS	Secondary endpoints are quality of life measured by validated questionnaires and interviews , and physical performance .
-METHODS	RESPECT includes a multimodal intervention program , including ambassador-facilitated educational , physical , and social interventions .
-METHODS	The educational intervention includes an educational program aimed at the child with cancer , the child 's schoolteachers and classmates , and the child 's parents .
-METHODS	Children with cancer will each have two ambassadors assigned from their class .
-METHODS	The ambassadors visit the child with cancer at the hospital at alternating 2-week intervals and participate in the intervention program .
-METHODS	The physical and social intervention examines the effect of early , structured , individualized , and continuous physical activity from diagnosis throughout the treatment period .
-METHODS	The patients are tested at diagnosis , at 3 and 6 months after diagnosis , and one year after the cessation of treatment .
-METHODS	The study is powered to quantify the impact of the combined educational , physical , and social intervention programs .
-CONCLUSIONS	RESPECT is the first population-based study to examine the effect of early rehabilitation for children with cancer , and to use healthy classmates as ambassadors to facilitate the normalization of social life in the hospital .
-CONCLUSIONS	For children with cancer , RESPECT contributes to expanding knowledge on rehabilitation that can also facilitate rehabilitation of other children undergoing hospitalization for long-term illness .
-BACKGROUND	Clinical Trials.gov : file .
-BACKGROUND	NCT01772849 and NCT01772862 .
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-###24861503
-BACKGROUND	Statin therapy is a cornerstone therapy for secondary prevention after acute coronary syndrome ( ACS ) .
-BACKGROUND	However , the use of these drugs can be limited by side effects , mainly muscular pain .
-BACKGROUND	Ezetimibe is a newer lipid-lowering agent , with fewer side effects .
-OBJECTIVE	The present study was designed to compare a commercially available association of ezetimibe and simvastatin ( E-S ) to high dose Rosuvastatin on cholesterol and muscular enzyme levels and occurrence of muscular pain .
-METHODS	All consecutive ACS statin-nave patients with LDL cholesterol ( LDL-C ) > 100mg/dL randomly received either high dose statin ( Rosuvastatin 20mg ) or E-S 10/40-mg .
-METHODS	All patients had one-month follow-up with biological testing and clinical examination .
-METHODS	We compared the two groups on the biological efficiency and incidence of muscular pain .
-RESULTS	One hundred and twenty-eight patients were randomized ; 64 received E-S and 64 Rosuvastatin .
-RESULTS	In the two groups , the lowering of LDL-C level ( = 51 % ) at one month was significant ( P < 0.01 ) without any difference in the rate of lowering on LDL-C or HDL-C suggesting that E-S is as effective as high dose Rosuvastatin ( P = 0.77 and P = 0.99 ) .
-RESULTS	The rate of patients reaching the objective of LDL-C < 100mg/dL ( 45 % ) and LDL-C < 70mg/dL ( 51 % ) was not different in the two clusters ( P = 0.65 ) .
-RESULTS	Incidence of muscular pain was 15 % higher in patients treated with Rosuvastatin ( P = 0.01 ) without any difference on CPK level ( P = 0.6 ) .
-CONCLUSIONS	Using an association of E-S in an effective alternative strategy to high dose Rosuvastatin with a lower incidence of muscular pain , which might impact adherence to medication after ACS .
-
-###24297633
-OBJECTIVE	The aim of this study was to compare the efficacy of the treatment of patients with spontaneous pneumothorax with air leak ( AL ) using two different chest drainage systems .
-METHODS	Patients were randomized into two groups : group A included 30 patients ( 23 males and 7 females , mean age 41.116.29 y , range 17-71 y ) in which digital drainage system was used , group B with 30 patients ( 22 males and 8 females , mean age 40.315.74 y , range 18-72 y ) in which traditional suction drainage system was applied.The following variables were evaluated : intensity of AL , duration of the chest tube drainage , delay in surgery , length of stay , and the overall hospitalization costs .
-RESULTS	In group A the mean drainage duration was 47.63 hours , the hospitalization time was about 5.10 days , and the cost of hospitalization was 1,495 .
-RESULTS	In group B the mean drainage duration was 84.93 hours , the hospitalization time was 6.97 days , and the hospitalization cost was 1,925 .
-CONCLUSIONS	The digital drainage system applied in the treatment of AL in patients with pneumothoraces reduced the duration of the drainage , the length of hospital stay , and overall hospitalization costs .
-
-###24607046
-BACKGROUND	MP29-02 is a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate ( FP ) in an advanced delivery system for the treatment of seasonal allergic rhinitis .
-OBJECTIVE	The objective of this study was to evaluate the long-term safety of MP29-02 in subjects with chronic allergic ( perennial ) or nonallergic ( vasomotor ) rhinitis .
-METHODS	This was a 1-year , randomized , open-label , active-controlled , parallel-group study in subjects with chronic allergic or nonallergic rhinitis .
-METHODS	A total of 612 subjects were randomized in a 2:1 ratio to ( 1 ) MP29-02 , one spray per nostril twice daily ( total daily doses of azelastine hydrochloride and FP were 548 mcg and 200 mcg , respectively ) ; or ( 2 ) FP , 2 sprays per nostril once daily ( total daily dose 200 mcg ) .
-METHODS	Safety and tolerability assessments were made at months 1 , 3 , 6 , 9 , and 12 .
-RESULTS	The incidence of treatment-related adverse events was low with both MP29-02 ( 9.4 % ) and FP ( 11.1 % ) , with no evidence of late-occurring adverse events .
-RESULTS	Nasal examinations showed no evidence of nasal mucosal ulcerations or septal perforations with MP29-02 , and the overall incidence of adverse findings was reduced as the study progressed .
-RESULTS	There were no unusual or unexpected ocular examination findings and no clinically important laboratory findings or clinically important differences between groups in fasting AM serum cortisol levels after 12 months of treatment .
-CONCLUSIONS	MP29-02 was well tolerated .
-CONCLUSIONS	There were no safety findings that would preclude the long-term use of MP29-02 in the treatment of allergic rhinitis .
-
-###25728587
-BACKGROUND	As treatment goals in Crohn 's disease ( CD ) evolve , targets now include clinical remission ( CR ) , mucosal healing ( MH ) and biological remission [ C-reactive protein normalisation ( CRPnorm ) ] .
-OBJECTIVE	To evaluate the association of baseline factors and treatment with the achievement of different composite remission parameters at week 26 .
-METHODS	This post hoc analysis of the SONIC trial evaluated different composite remission measures at week 26 in a subgroup of patients with Crohn 's disease activity index ( CDAI ) scores , CRP , and endoscopic data available at baseline and week 26 ( N = 188 ) .
-METHODS	Assessed composite remission measures were : CR ( CDAI < 150 ) and MH ( absence of any mucosal ulcerations ) , previously referred to as ` deep remission ; ' and alternative composite endpoints : CR+CRP norm ( CRP < 0.8 mg/dL ) ; CRPnorm + MH ; and CR+CRP norm + MH .
-RESULTS	Among analysed patients , 136/188 ( 72.3 % ) achieved CR and 90/188 ( 47.9 % ) achieved MH at week 26 .
-RESULTS	All composite outcomes were significantly greater ( Bonferroni significance level , P0 .016 ) with combination therapy ( i.e. infliximab and azathioprine ; 52.3-63 .6 % ) vs. azathioprine monotherapy ( 12.9-29 .0 % ; p 0.005 for all comparisons ) .
-RESULTS	Composite remission rates including MH were significantly greater with combination therapy ( 52.3-56 .9 % ) vs. infliximab ( 25.6-32 .3 % ; P0 .015 for all comparisons except CRPnorm + MH , P = 0.017 ) and vs. azathioprine monotherapy ( 12.9-20 .4 % ; P0 .002 for all comparisons ) .
-RESULTS	Median serum trough infliximab concentrations among patients who achieved MH or CR+MH were greater when compared with those among patients who did not achieve MH ( P = 0.018 ) or CR+MH ( P = 0.053 ) .
-RESULTS	Among the subgroup of patients with early Crohn 's disease , MH alone or in combination with composite remission criteria significantly improved clinical outcomes of patients who received combination therapy .
-CONCLUSIONS	Combination therapy was more effective in achieving various composite remission measures vs. azathioprine or infliximab monotherapy .
-CONCLUSIONS	These data illustrate that ` deep remission ' is achievable with combination therapy in a high percentage of patients with early Crohn 's disease .
-CONCLUSIONS	ClinicalTrials.gov number : NCT00094458 .
-
-###24273179
-BACKGROUND	We compared the immunogenicity and reactogenicity of Cervarix or Gardasil human papillomavirus ( HPV ) vaccines in adults infected with the human immunodeficiency virus ( HIV ) .
-METHODS	This was a double-blind , controlled trial randomizing HIV-positive adults to receive 3 doses of Cervarix or Gardasil at 0 , 1.5 , and 6 months .
-METHODS	Immunogenicity was evaluated for up to 12 months .
-METHODS	Neutralizing anti-HPV-16 / 18 antibodies were measured by pseudovirion-based neutralization assay .
-METHODS	Laboratory tests and diary cards were used for safety assessment .
-METHODS	The HPV-DNA status of the participants was determined before and after immunization .
-RESULTS	Ninety-two participants were included in the study .
-RESULTS	Anti-HPV-18 antibody titers were higher in the Cervarix group compared with the Gardasil group at 7 and 12 months .
-RESULTS	No significant differences in anti-HPV-16 antibody titers were found among vaccine groups .
-RESULTS	Among Cervarix vaccinees , women had higher anti-HPV-16 / 18 antibody titers compared to men .
-RESULTS	No sex-specific differences in antibody titers were found in the Gardasil group .
-RESULTS	Mild injection site reactions were more common in the Cervarix group than in the Gardasil group ( 91.1 % vs 69.6 % ; P = .02 ) .
-RESULTS	No serious adverse events occurred .
-CONCLUSIONS	Both vaccines were immunogenic and well tolerated .
-CONCLUSIONS	Compared with Gardasil , Cervarix induced superior vaccine responses among HIV-infected women , whereas in HIV-infected men the difference in immunogenicity was less pronounced .
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-###25457902
-OBJECTIVE	This study sought to evaluate the effect of macitentan on hospitalization of patients with symptomatic pulmonary arterial hypertension ( PAH ) .
-BACKGROUND	PAH is a progressive , life-threatening disease often requiring hospitalization .
-METHODS	In the multicenter , double-blind , randomized , event-driven , phase III SERAPHIN ( Study with an Endothelin Receptor Antagonist in Pulmonary arterial Hypertension to Improve cliNical outcome ) trial , patients with symptomatic PAH were randomized ( 1:1:1 ) to receive placebo or 3 mg or 10 mg of macitentan .
-METHODS	Effects of macitentan on the risk , rate , and number of hospital days for all-cause and PAH-related hospitalizations were compared with those for placebo .
-METHODS	Risk and causes of hospitalizations unrelated to PAH were investigated .
-RESULTS	Of 742 randomized patients , 250 received placebo , 250 received 3 mg of macitentan , and 242 received 10 mg of macitentan ; the overall median duration of treatment was 115 weeks .
-RESULTS	Risk of all-cause hospitalization was reduced by 18.9 % ( p = 0.1208 ) and 32.3 % ( p = 0.0051 ) in the macitentan 3-mg and 10-mg arm , respectively .
-RESULTS	Rates of all-cause hospitalizations and numbers of hospital days were reduced by 20.5 % ( p = 0.0378 ) and 30.6 % ( p = 0.0278 ) , respectively , with 3 mg of macitentan and by 33.1 % ( p = 0.0005 ) and 31.0 % ( p = 0.0336 ) , respectively , with 10 mg of macitentan .
-RESULTS	Risk of PAH-related hospitalizations were reduced by 42.7 % ( p = 0.0015 ) and 51.6 % ( p < 0.0001 ) in the macitentan 3-mg and 10-mg arms , respectively .
-RESULTS	Rate of PAH-related hospitalizations and numbers of hospital days were reduced by 44.5 % ( p = 0.0004 ) and 53.3 % ( p = 0.0001 ) , respectively , with 3 mg of macitentan , and reduced by 49.8 % ( p < 0.0001 ) and 52.3 % ( p = 0.0003 ) , respectively , with 10 mg of macitentan .
-RESULTS	Risk of non-PAH-related hospitalization was similar between treatment arms .
-CONCLUSIONS	Macitentan 10 mg significantly reduced the risk and rate of all-cause hospitalization , which was driven by reductions in the risk and rate of PAH-related hospitalization .
-CONCLUSIONS	( Study of Macitentan [ ACT-064992 ] on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension ; NCT00660179 ) .
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-###25812845
-BACKGROUND	Sequential compression devices ( SCDs ) reduce deep venous thrombosis in postsurgical patients , but the use is hindered by poor compliance .
-METHODS	General and orthopedic surgery patients ( n = 67 ) were randomized to standard - or battery-powered SCDs .
-METHODS	Compliance was documented hourly .
-METHODS	Nurses and patients were issued a survey to assess barriers to compliance and device satisfaction .
-RESULTS	Compliance with standard SCDs was 47 % compared with 85 % with battery-powered SCDs ( P < .001 ) .
-RESULTS	The most common barriers identified by nurses and patients were ambulation and transfers , which were mitigated with the battery-powered device .
-RESULTS	A majority ( 79 % ) of those issued a battery-powered device reported no major problems compared with only 14 % of patients issued a standard device ( P < .005 ) .
-CONCLUSIONS	The dual venous thromboembolism prevention strategies of early mobilization and SCD utilization can be met with the appropriate equipment .
-
-###25300507
-OBJECTIVE	The aim of this study was to evaluate the cost effectiveness of ranibizumab compared with verteporfin photodynamic therapy ( vPDT ) or no treatment ( observation ) in patients with visual impairment due to myopic choroidal neovascularization ( CNV ) .
-METHODS	A Markov model with health states defined by best-corrected visual acuity and a 3-month cycle length was developed .
-METHODS	It had a healthcare provider ( UK National Health Service and personal social services ) perspective , a lifetime time horizon , and was based on 2011 prices ; future costs and health outcomes were discounted at 3.5 % per annum .
-METHODS	Baseline characteristics were based on the phase III RADIANCE ( Ranibizumab and vPDT Evaluation in Myopic CNV ) study , and year 1 health-state transitions were based on this and the VIP ( Verteporfin in Photodynamic Therapy ) study .
-METHODS	Extensive sensitivity analyses tested the robustness of the model .
-RESULTS	The lifetime cost of treating myopic CNV with ranibizumab was 12,866 , whereas vPDT and observation were associated with total costs of 14,421 and 8,163 , respectively .
-RESULTS	Ranibizumab treatment produced higher cumulative quality-adjusted life-years ( QALYs ; 12.99 ) than vPDT ( 12.60 ) or observation ( 12.45 ) .
-RESULTS	Ranibizumab treatment was therefore dominant , with greater health gains and lower overall costs than vPDT .
-RESULTS	Ranibizumab was cost effective compared with observation , with an incremental cost-effectiveness ratio of 8,778 / QALY .
-RESULTS	In the probabilistic sensitivity analysis , ranibizumab had a 100 % and 88 % probability of being cost effective compared with vPDT and observation , respectively , at a willingness-to-pay threshold of 20,000 / QALY .
-CONCLUSIONS	This study indicates that ranibizumab therapy is dominant over vPDT for the treatment of visual impairment due to CNV secondary to pathologic myopia in the UK healthcare setting and cost effective compared with observation .
-
-###25583754
-OBJECTIVE	To evaluate the efficacy and safety of combinations of empagliflozin/linagliptin as second-line therapy in subjects with type 2 diabetes inadequately controlled on metformin .
-METHODS	Subjects were randomized to a combination of empagliflozin 25 mg/linagliptin 5 mg ( n = 137 ) , empagliflozin 10 mg/linagliptin 5 mg ( n = 136 ) , empagliflozin 25 mg ( n = 141 ) , empagliflozin 10 mg ( n = 140 ) , or linagliptin 5 mg ( n = 132 ) as add-on to metformin for 52 weeks .
-METHODS	The primary end point was change from baseline in HbA1c at week 24 .
-RESULTS	At week 24 , reductions in HbA1c ( mean baseline 7.90-8 .02 % [ 62.8-64 .1 mmol/mol ] ) with empagliflozin/linagliptin were superior to those with empagliflozin or linagliptin alone as add-on to metformin ; adjusted mean ( SE ) changes from baseline were -1.19 % ( 0.06 ) ( -13.1 mmol/mol [ 0.7 ] ) with empagliflozin 25 mg/linagliptin 5 mg , -1.08 % ( 0.06 ) ( -11.8 mmol/mol [ 0.7 ] ) with empagliflozin 10 mg/linagliptin 5 mg , -0.62 % ( 0.06 ) ( -6.8 mmol/mol [ 0.7 ] ) with empagliflozin 25 mg , -0.66 % ( 0.06 ) ( -7.2 mmol/mol [ 0.7 ] ) with empagliflozin 10 mg , and -0.70 % ( 0.06 ) ( -7.6 mmol/mol [ 0.7 ] ) with linagliptin 5 mg ( P < 0.001 for all comparisons ) .
-RESULTS	In these groups , respectively , 61.8 , 57.8 , 32.6 , 28.0 , and 36.1 % of subjects with baseline HbA1c 7 % ( 53 mmol/mol ) had HbA1c < 7 % ( < 53 mmol/mol ) at week 24 .
-RESULTS	Efficacy was maintained at week 52 .
-RESULTS	The proportion of subjects with adverse events ( AEs ) over 52 weeks was similar across treatment arms ( 68.6-73 .0 % ) , with no hypoglycemic AEs requiring assistance .
-CONCLUSIONS	Combinations of empagliflozin/linagliptin as second-line therapy for 52 weeks significantly reduced HbA1c compared with the individual components and were well tolerated .
-
-###25065535
-BACKGROUND	Cannabis use is high amongst young people who have recently had their first episode of psychosis , and is associated with worse outcomes .
-BACKGROUND	To date , interventions to reduce cannabis consumption have been largely ineffective , and it has been suggested that longer treatment periods are required .
-METHODS	In a pragmatic single-blind randomized controlled trial 110 participants were randomly allocated to one of three conditions : a brief motivational interviewing and cognitive behavioural therapy ( MI-CBT ) intervention ( up to 12 sessions over 4.5 months ) with standard care from an early intervention service ; a long MI-CBT intervention ( up to 24 sessions over 9 months ) with standard care ; or standard care alone .
-METHODS	The primary outcome was change in cannabis use as measured by Timeline Followback .
-RESULTS	Neither the extended nor the brief interventions conferred benefit over standard care in terms of reductions in frequency or amount of cannabis use .
-RESULTS	Also the interventions did not result in improvements in the assessed clinical outcomes , including symptoms , functioning , hospital admissions or relapse .
-CONCLUSIONS	Integrated MI and CBT for people with cannabis use and recent-onset psychosis does not reduce cannabis use or improve clinical outcomes .
-CONCLUSIONS	These findings are consistent with those in the published literature , and additionally demonstrate that offering a more extended intervention does not confer any advantage .
-CONCLUSIONS	Many participants were not at an action stage for change and for those not ready to reduce or quit cannabis , targeting associated problems rather than the cannabis use per se may be the best current strategy for mental health services to adopt .
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-###25882438
-OBJECTIVE	Emerging evidence has suggested that platelet-rich plasma ( PRP ) might be of assistance in the treatment of degenerative conditions of the joints .
-OBJECTIVE	The aim of the present study was to compare the use of PRP and hyaluronic acid ( HA ) in the treatment of temporomandibular joint ( TMJ ) osteoarthritis ( OA ) with long-term follow-up data .
-METHODS	Patients meeting the Research Diagnostic Criteria for TMJ-OA were randomly assigned to 1 of 2 study groups that received either PRP or HA .
-METHODS	The outcome variables were maximum nonassisted ( voluntary ) mouth opening ( MVMO ) , joint sounds , and pain index scores .
-METHODS	Other variables , including patient age and gender , were evaluated in relation to the outcomes .
-METHODS	Descriptive and bivariate statistics were computed , and the P value was set at .05 .
-RESULTS	A total of 50 patients with TMJ-OA were enrolled in the study ( 29 women and 21 men , age range 31 to 49 years , mean age 38.6 ) .
-RESULTS	In group I , 25 patients received 3 injections of 1 mL of PRP .
-RESULTS	In group II , 25 patients received 3 injections of 1 mL of low-molecular-weight HA .
-RESULTS	Between-group comparisons of the outcome variables over time revealed significant improvements in group II at 1 and 3 months .
-RESULTS	At 6 and 12 months , the PRP group exhibited better performance compared with the HA group in terms of the recurrence of pain and joint sounds .
-RESULTS	The improvements obtained with the PRP injections in group I were maintained during the follow-up period .
-RESULTS	At the end of the follow-up period , the median MVMO in group I was 41.0 mm .
-RESULTS	In group II , the median MVMO was 39.0 mm .
-CONCLUSIONS	PRP performed better than HA acid in the treatment of TMJ-OA during long-term follow-up in terms of pain reduction and increased interincisal distance .
-CONCLUSIONS	Future studies will focus on the synergistic actions of HA and PRP in the treatment of TMJ-OA .
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-###24247476
-OBJECTIVE	Intensive insulin therapy for tight glycemic control in critically ill surgical patients has been shown to reduce mortality ; however , intensive insulin therapy is associated with iatrogenic hypoglycemia and increased variability of blood glucose levels .
-OBJECTIVE	The incretin glucagon-like peptide-1 ( 7-36 ) amide is both insulinotropic and insulinomimetic and has been suggested as an adjunct to improve glycemic control in critically ill patients .
-OBJECTIVE	We hypothesized that the addition of continuous infusion of glucagon-like peptide-1 to intensive insulin therapy would result in better glucose control , reduced requirement of exogenous insulin administration , and fewer hypoglycemic events .
-METHODS	Prospective , randomized , double-blind , placebo-controlled clinical trial .
-METHODS	Surgical or burn ICU .
-METHODS	Eighteen patients who required intensive insulin therapy .
-METHODS	A 72-hour continuous infusion of either glucagon-like peptide-1 ( 1.5 pmol/kg/min ) or normal saline plus intensive insulin therapy .
-RESULTS	The glucagon-like peptide-1 cohort ( n = 9 ) and saline cohort ( n = 9 ) were similar in age , Acute Physiology and Chronic Health Evaluation score , and history of diabetes .
-RESULTS	Blood glucose levels in the glucagon-like peptide-1 group were better controlled with much less variability .
-RESULTS	The coefficient of variation of blood glucose ranged from 7.2 % to 30.4 % in the glucagon-like peptide-1 group and from 19.8 % to 56.8 % in saline group .
-RESULTS	The mean blood glucose coefficient of variation for the glucagon-like peptide-1 and saline groups was 18.0 % 2.7 % and 30.3 % 4.0 % ( p = 0.010 ) , respectively .
-RESULTS	The 72-hour average insulin infusion rates were 3.37 0.61 and 4.57 1.18 U/hr ( p = not significant ) .
-RESULTS	The incidents of hypoglycemia ( 2.78 mmol/L ) in both groups were low ( one in the glucagon-like peptide-1 group , three in the saline group ) .
-CONCLUSIONS	Glucagon-like peptide-1 ( 7-36 ) amide is a safe and efficacious form of adjunct therapy in patients with hyperglycemia in the surgical ICU setting .
-CONCLUSIONS	Improved stability of blood glucose is a favorable outcome , which enhances the safety of intensive insulin therapy .
-CONCLUSIONS	Larger studies of this potentially valuable therapy for glycemic control in the ICU are justified .
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-###24666774
-OBJECTIVE	In a randomized controlled trial of a preoperative education intervention conducted for Chinese cardiac patients , we observed a greater effect on symptoms of anxiety and depression than that reported with regard to similar interventions in western care settings .
-OBJECTIVE	The objective of this qualitative study was to help explain the findings of the trial by exploring Chinese patients ' experience of seeking and receiving information before cardiac surgery .
-METHODS	Semi-structured interviews were conducted with a purposive sample of 20 trial participants before discharge ( ten from the preoperative education group ; ten from the usual care control group ) .
-METHODS	Data were analyzed using a thematic analysis approach .
-RESULTS	A total of five themes were generated : the role of reputation and hierarchy ; gaining strength from knowledge ; information as a low priority ; being kept in the dark ; and learning through peer support .
-CONCLUSIONS	In health care systems where service users are given relatively little information , interventions designed to inform patients about their treatment are likely to have a much greater impact on their psychological health .
-CONCLUSIONS	Providers of services for patients undergoing cardiac surgery in China should be encouraged to incorporate information giving into routine practice , tailored according to individual need .
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-###25056465
-OBJECTIVE	To compare two incision angles ( 60 vs 40 ) of mediolateral episiotomy in primiparous Egyptian women , regarding the incidence of anal sphincter injury as well as episiotomy-related pain and dyspareunia .
-METHODS	The current prospective randomized controlled trial ( ClinicalTrials.gov , NCT01930721 ) was conducted at Ain Shams University Maternity Hospital .
-METHODS	Eligible women were randomized into two groups : group 1 included women who had the episiotomy incision made at an angle of 60 to the midline ; and group 2 included women who had the episiotomy incision made at an angle of 40 to the midline .
-METHODS	Primary outcome measures were differences in short-term related pain and rate of third/fourth degree perineal tears .
-RESULTS	A total of 330 primiparous women were recruited .
-RESULTS	The shortest distance to the outer edge of the anal epithelium was significantly shorter in women of group 2 when compared to that in women of group 1 .
-RESULTS	Out of the included 330 women , 13 ( 4 % ) had third/fourth-degree perineal tears ( 4 [ 2.4 % ] in group 1 in contrast to nine [ 5.5 % ] in group 2 ) .
-RESULTS	This difference was not significant A 60-angled mediolateral episiotomy was associated with significantly higher rates of moderate/severe episiotomy-related pain post-partum .
-RESULTS	The rates of moderate/severe episiotomy-related pain and dyspareunia assessed 6 months post-partum were also higher among women of group 1 , when compared to group 2 ; the latter two differences did not reach statistical significance , however .
-CONCLUSIONS	When compared to the 40-angled mediolateral episiotomies , 60-angled ones were associated with significantly higher short-term-related pain .
-CONCLUSIONS	Although they were also associated with lower rate of third/fourth-degree perineal tears and higher rate of long-term related pain and dyspareunia , these differences did not reach a statistically significant level .
-
-###24486366
-OBJECTIVE	A suboptimal level of seasonal influenza vaccination among pregnant minority women is an intractable public health problem , requiring effective message resonance with this population .
-OBJECTIVE	We evaluated the effects of randomized exposure to messages which emphasize positive outcomes of vaccination ( `` gain-frame '' ) , or messages which emphasize negative outcomes of forgoing vaccination ( `` loss-frame '' ) .
-OBJECTIVE	We also assessed multilevel social and community factors that influence maternal immunization among racially and ethnically diverse populations .
-METHODS	Minority pregnant women in metropolitan Atlanta were enrolled in the longitudinal study and randomized to receive intervention or control messages .
-METHODS	A postpartum questionnaire administered 30 days postpartum evaluated immunization outcomes following baseline message exposure among the study population .
-METHODS	We evaluated key outcomes using bivariate and multivariate analyses .
-RESULTS	Neither gain - [ OR = 0.5176 , ( 95 % CI : 0.203,1.322 ) ] nor loss-framed [ OR = 0.5000 , 95 % CI : ( 0.192,1.304 ) ] messages were significantly associated with increased likelihood of immunization during pregnancy .
-RESULTS	Significant correlates of seasonal influenza immunization during pregnancy included healthcare provider recommendation [ OR = 3.934 , 95 % CI : ( 1.331,11.627 ) ] , use of hospital-based practices as primary source of prenatal care [ OR = 2.584 , 95 % CI : ( 1.091,6.122 ) ] , and perceived interpersonal support for influenza immunization [ OR = 3.405 , 95 % CI : ( 1.412,8.212 ) ] .
-CONCLUSIONS	Dissemination of vaccine education messages via healthcare providers , and cultivating support from social networks , will improve seasonal influenza immunization among pregnant minority women .
-
-###24833315
-OBJECTIVE	This randomised clinical trial assessed the effects of a 16-week cognitive remediation programme ( NEUROCOM ) combined with an early intervention service ( EIS ) vs. EIS alone .
-METHODS	One hundred and seventeen patients with first episode psychosis were randomly assigned to 4 months cognitive remediation combined with EIS vs. EIS alone .
-METHODS	Statistical analysis of effect was based on intention to treat .
-RESULTS	A total of 98 patients ( 83.8 % ) participated in post-training assessments at 4 months and 92 ( 78.6 % ) in 12-month follow-up assessments .
-RESULTS	No effects were found on the primary outcome measure functional capacity .
-RESULTS	At the post-training assessment , the intervention group had improved significantly on Rosenberg Self-Esteem Scale ( Cohen 's d = 0.54 , P = 0.01 ) , Positive and Negative Symptoms Scale ( PANSS ) , General Psychopathology Scale ( Cohen 's d = 0.51 , P = 0.05 ) and the verbal learning domain ( Cohen 's d = 0.46 , P = 0.02 ) .
-RESULTS	At follow-up assessment , the intervention group retained the significant improvements on the verbal learning domain ( Cohen 's d = 0.58 , P < 0.05 ) .
-RESULTS	Furthermore , significant improvements were observed on the working memory domain ( Cohen 's d = 0.56 , P = 0.01 ) and PANSS positive symptoms ( Cohen 's d = 0.44 , P = 0.04 ) , while improvement on the composite score was marginally significant ( Cohen 's d = 0.34 , P = 0.05 ) .
-CONCLUSIONS	In accordance with other cognitive remediation programmes , this programme demonstrates some immediate and long-term effect on cognitive functioning , symptoms and self-esteem .
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-###25065337
-BACKGROUND	In previous studies , we identified two urinary proteomic classifiers , termed HF1 and HF2 , which discriminated subclinical diastolic left ventricular ( LV ) dysfunction from normal .
-BACKGROUND	HF1 and HF2 combine information from 85 and 671 urinary peptides , mainly up - or down-regulated collagen fragments .
-BACKGROUND	We sought to validate these classifiers in a population study .
-METHODS	In 745 people randomly recruited from a Flemish population ( 49.8 years ; 51.3 % women ) , we measured early and late diastolic peak velocities of mitral inflow ( E and A ) and mitral annular velocities ( e ' and a ' ) by conventional and tissue Doppler echocardiography , and the urinary proteome by capillary electrophoresis coupled with mass spectrometry .
-RESULTS	In the analyses adjusted for sex , age , body mass index , blood pressure , heart rate , LV mass index and intake of medications , we expressed effect sizes per 1-SD increment in the classifiers .
-RESULTS	HF1 was associated with 0.204 cm/s lower e ' peak velocity ( 95 % confidence interval , 0.057-0 .351 ; p = 0.007 ) and 0.145 higher E/e ' ratio ( 0.023-0 .268 ; p = 0.020 ) , while HF2 was associated with a 0.174 higher E/e ' ratio ( 0.046-0 .302 ; p = 0.008 ) .
-RESULTS	According to published definitions , 67 ( 9.0 % ) participants had impaired LV relaxation and 96 ( 12.9 % ) had elevated LV filling pressure .
-RESULTS	The odds of impaired relaxation associated with HF1 was 1.38 ( 1.01-1 .88 ; p = 0.043 ) and that of increased LV filling pressure associated with HF2 was 1.38 ( 1.00-1 .90 ; p = 0.052 ) .
-CONCLUSIONS	In a general population , the urinary proteome correlated with diastolic LV dysfunction , proving its utility for early diagnosis of this condition .
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-###25061702
-OBJECTIVE	To evaluate the pharmacokinetics and thermal and mechanical antinociceptive effects of a fentanyl constant rate infusion ( CRI ) in conscious cats .
-METHODS	8 healthy adult cats .
-METHODS	At a 14-day interval , 7 cats received a loading dose ( LD ) of fentanyl ( 5 g/kg , IV [ administered at 0 hours ] ) followed by fentanyl infusion ( 5 g/kg/h , IV ) for 2 hours or similar administrations of equivalent volumes of 0.9 % saline ( NaCl ) solution .
-METHODS	One cat received only the fentanyl treatment .
-METHODS	For both treatments , sedation and adverse events were evaluated and mechanical threshold ( MT ) and thermal threshold ( TT ) testing was performed prior to ( baseline ) and at predetermined times up to 26 hours after LD administration ; plasma fentanyl concentrations were determined at similar times when the cats received fentanyl .
-RESULTS	Fentanyl induced mild sedation during the infusion .
-RESULTS	The only adverse effect associated with fentanyl LD administration was profuse salivation ( 1 cat ) .
-RESULTS	Saline solution administration did not significantly change MT or TT over time .
-RESULTS	For the duration of the CRI , MT and TT differed significantly between treatments , except for TT 1 hour after LD administration .
-RESULTS	For the fentanyl treatment , MT and TT were significantly higher than baseline at 0.25 to 0.75 hours and at 0.25 to 1 hour , respectively .
-RESULTS	During the fentanyl CRI , mean SD plasma fentanyl concentration decreased from 4.41 1.86 ng/mL to 2.99 1.28 ng/mL and was correlated with antinociception ; plasma concentrations < 1.33 0.30 ng/mL were not associated with antinociception .
-CONCLUSIONS	Fentanyl CRI ( 5 g/kg/h ) induced mechanical and thermal antinociception in cats .
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-###24882698
-BACKGROUND	To investigate the performance of the MI Sxscore in a multicentre randomised trial of patients undergoing primary percutaneous coronary intervention ( PPCI ) .
-RESULTS	The MI Sxscore was prospectively determined among 1132 STEMI patients enrolled into the COMFORTABLE AMI trial , which randomised patients to treatment with bare-metal ( BMS ) or biolimus-eluting ( BES ) stents .
-RESULTS	Patient - ( death , myocardial infarction , any revascularisation ) and device-oriented ( cardiac death , target-vessel MI , target lesion revascularisation ) major adverse cardiac events ( MACEs ) were compared across MI Sxscore tertiles and according to stent type .
-RESULTS	The median MI SXscore was 14 ( IQR : 9-21 ) .
-RESULTS	Patients were divided into tertiles of Sxscorelow ( 10 ) , Sxscoreintermediate ( 11-18 ) and Sxscorehigh ( 19 ) .
-RESULTS	At 1 year , patient-oriented MACE occurred in 15 % of the Sxscorehigh , 9 % of the Sxscoreintermediate and 5 % of the Sxscorelow tertiles ( p < 0.001 ) , whereas device-oriented MACE occurred in 8 % of the Sxscorehigh , 6 % of the Sxscoreintermediate and 4 % of the Sxscorelow tertiles ( p = 0.03 ) .
-RESULTS	Addition of the MI Sxscore to the TIMI risk score improved prediction of patient - ( c-statistic value increase from 0.63 to 0.69 ) and device-oriented MACEs ( c-statistic value increase from 0.65 to 0.70 ) .
-RESULTS	Differences in the risk for device-oriented MACE between BMS and BES were evident among Sxscorehigh ( 13 % vs. 4 % HR 0.33 ( 0.15-0 .74 ) , p = 0.007 rather than those in Sxscorelow : 4 % vs. 3 % HR 0.68 ( 0.24-1 .97 ) , p = 0.48 ) tertiles .
-CONCLUSIONS	The MI Sxscore allows risk stratification of patient - and device-oriented MACEs among patients undergoing PPCI .
-CONCLUSIONS	The addition of the MI Sxscore to the TIMI risk score is of incremental prognostic value among patients undergoing PPCI for treatment of STEMI .
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-###24949605
-OBJECTIVE	To compare the efficacy and tolerance of sodium picosulphate/magnesium citrate ( PMC ) and polyethylene glycol ( PEG ) in a single or split dose regimen for colonoscopy bowel preparation .
-METHODS	A prospective , randomized , endoscopist-blinded , multicenter study .
-METHODS	The patients were randomly assigned to receive PMC ( PMC4/0 ) or PEG ( PEG4/0 ) in a single dose 4L day before colonoscopy or a split dose 2 +2 L PMC ( PMC2/2 ) or 3 +1 L PEG ( PEG3/1 ) one day before and in the morning before the colonoscopy .
-METHODS	Each patient was interviewed to determine his/her subjective tolerance of the preparation before the procedure .
-METHODS	The quality of bowel cleansing was assessed in a blinded test performed by multiple endoscopists using the Aronchick scale .
-RESULTS	A total of 600 patients were enrolled , 88.2 % were included in the analysis .
-RESULTS	Satisfactory bowel cleansing ( Aronchick score 1 and 2 ) was significantly more frequent when a split dose was used irrespective of the solution type ( 81.6 % PMC2/2 , 87.3 % PEG3/1 vs. 73.0 % PEG4/0 , p = 0.024 ) .
-RESULTS	In single dose regimens , PMC performed better than PEG ( 82.6 % vs. 73.0 % ) .
-RESULTS	Single or split dose PMC preparations were comparable .
-RESULTS	A PMC based solution was generally better tolerated than PEG regardless of the regimen used ( p < 0.001 ) .
-RESULTS	Nausea was reported mostly after the 4L PEG ( 32.8 % , p < 0.001 ) , incontinence after a split PMC dose ( 34.4 % , p = 0.002 ) , and bloating after the 4L PEG ( 38.0 % , p < 0.001 ) .
-RESULTS	There was no significant difference in the prevalence of vomiting .
-CONCLUSIONS	Colonic preparation with PMC yields similar results as a split PEG dose , regardless of whether PMC is administered in single or separate doses .
-CONCLUSIONS	PMC is better tolerated than any PEG-based preparation .
-CONCLUSIONS	A single 4L PEG the day before the colonoscopy is less appropriate for bowel cleansing .
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-###25611785
-BACKGROUND	Chronic obstructive pulmonary disease ( COPD ) is a heterogeneous disease and likely includes a subgroup that is biologically comparable to asthma .
-BACKGROUND	Studying asthma-associated gene expression changes in COPD could add insight into COPD pathogenesis and reveal biomarkers that predict a favorable response to corticosteroids .
-OBJECTIVE	To determine whether asthma-associated gene signatures are increased in COPD and associated with asthma-related features .
-METHODS	We compared disease-associated airway epithelial gene expression alterations in an asthma cohort ( n = 105 ) and two COPD cohorts ( n = 237 , 171 ) .
-METHODS	The T helper type 2 ( Th2 ) signature ( T2S ) score , a gene expression metric induced in Th2-high asthma , was evaluated in these COPD cohorts .
-METHODS	The T2S score was correlated with asthma-related features and response to corticosteroids in COPD in a randomized , placebo-controlled trial , the Groningen and Leiden Universities study of Corticosteroids in Obstructive Lung Disease ( GLUCOLD ; n = 89 ) .
-RESULTS	The 200 genes most differentially expressed in asthma versus healthy control subjects were enriched among genes associated with more severe airflow obstruction in these COPD cohorts ( P < 0.001 ) , suggesting significant gene expression overlap .
-RESULTS	A higher T2S score was associated with decreased lung function ( P < 0.001 ) , but not asthma history , in both COPD cohorts .
-RESULTS	Higher T2S scores correlated with increased airway wall eosinophil counts ( P = 0.003 ) , blood eosinophil percentage ( P = 0.03 ) , bronchodilator reversibility ( P = 0.01 ) , and improvement in hyperinflation after corticosteroid treatment ( P = 0.019 ) in GLUCOLD .
-CONCLUSIONS	These data identify airway gene expression alterations that can co-occur in asthma and COPD .
-CONCLUSIONS	The association of the T2S score with increased severity and `` asthma-like '' features ( including a favorable corticosteroid response ) in COPD suggests that Th2 inflammation is important in a COPD subset that can not be identified by clinical history of asthma .
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-###24359938
-OBJECTIVE	To compare the efficacy and safety of oral paracetamol and oral ibuprofen for the pharmacological closure of patent ductus arteriosus ( PDA ) in preterm infants .
-METHODS	This prospective , randomized , controlled study enrolled 90 preterm infants with gestational age 30 weeks , birthweight 1250 g , and postnatal age 48 to 96 hours who had echocardiographically confirmed significant PDA .
-METHODS	Each enrolled patient received either oral paracetamol ( 15 mg/kg every 6 hours for 3 days ) or oral ibuprofen ( initial dose of 10 mg/kg , followed by 5 mg/kg at 24 and 48 hours ) .
-RESULTS	Spontaneous closure rate for the entire study group was 54 % .
-RESULTS	After the first course of treatment , the PDA closed in 31 ( 77.5 % ) of the patients assigned to the oral ibuprofen group vs 29 ( 72.5 % ) of those enrolled in the oral paracetamol group ( P = .6 ) .
-RESULTS	The reopening rate was higher in the paracetamol group than in the ibuprofen group , but the reopening rates were not statistically different ( 24.1 % [ 7 of 29 ] vs 16.1 % [ 5 of 31 ] ; P = .43 ) .
-RESULTS	The cumulative closure rates after the second course of drugs were high in both groups .
-RESULTS	Only 2 patient ( 2.5 % ) in the paracetamol group and 3 patients ( 5 % ) in the ibuprofen group required surgical ligation .
-CONCLUSIONS	This randomized , controlled clinical study compared oral paracetamol with ibuprofen in preterm infants and demonstrated that paracetamol may be a medical alternative in the management of PDA .
-
-###25054836
-OBJECTIVE	Select cases of intractable obsessive-compulsive disorder ( OCD ) have undergone neurosurgical ablation for more than half a century .
-OBJECTIVE	However , to our knowledge , there have been no randomized clinical trials of such procedures for the treatment of any psychiatric disorder .
-OBJECTIVE	To determine the efficacy and safety of a radiosurgery ( gamma ventral capsulotomy [ GVC ] ) for intractable OCD .
-METHODS	In a double-blind , placebo-controlled , randomized clinical trial , 16 patients with intractable OCD were randomized to active ( n = 8 ) or sham ( n = 8 ) GVC .
-METHODS	Blinding was maintained for 12 months .
-METHODS	After unblinding , sham-group patients were offered active GVC .
-METHODS	Patients randomized to active GVC had 2 distinct isocenters on each side irradiated at the ventral border of the anterior limb of the internal capsule .
-METHODS	The patients randomized to sham GVC received simulated radiosurgery using the same equipment .
-METHODS	Scores on the Yale-Brown Obsessive-Compulsive Scale ( Y-BOCS ) and the Clinical Global Impression-Improvement ( CGI-I ) Scale .
-METHODS	Response was defined as a 35 % or greater reduction in Y-BOCS severity and `` improved '' or `` much improved '' CGI-I ratings .
-RESULTS	Three of 8 patients randomized to active treatment responded at 12 months , while none of the 8 sham-GVC patients responded ( absolute risk reduction , 0.375 ; 95 % CI , 0.04-0 .71 ) .
-RESULTS	At 12 months , OCD symptom improvement was significantly higher in the active-GVC group than in the sham group ( Y-BOCS , P = .046 ; Dimensional Y-BOCS , P = .01 ) .
-RESULTS	At 54 months , 2 additional patients in the active group had become responders .
-RESULTS	Of the 4 sham-GVC patients who later received active GVC , 2 responded by post-GVC month 12 .
-RESULTS	The most serious adverse event was an asymptomatic radiation-induced cyst in 1 patient .
-CONCLUSIONS	Gamma ventral capsulotomy benefitted patients with otherwise intractable OCD and thus appears to be an alternative to deep-brain stimulation in selected cases .
-CONCLUSIONS	Given the risks inherent in any psychiatric neurosurgery , such procedures should be conducted at specialized centers .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01004302 .
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-###26065986
-BACKGROUND	Vitamin K-dependent factors protect against vascular and renovascular calcification , and vitamin K antagonists may be associated with a decreased glomerular filtration rate ( GFR ) .
-OBJECTIVE	This study analyzed changes in GFR during long-term treatment with warfarin or dabigatran etexilate ( DE ) in patients enrolled in the RE-LY ( Randomized Evaluation of Long Term Anticoagulation Therapy ) trial .
-METHODS	Of the 18,113 patients in the RE-LY study randomized to receive DE ( 110 mg or 150 mg twice daily ) or warfarin , 16,490 patients with atrial fibrillation had creatinine values measured at baseline and at least 1 follow-up visit .
-METHODS	Changes in GFR for up to 30 months were evaluated .
-RESULTS	GFR declined in all treatment groups .
-RESULTS	After an average of 30 months , the mean SE decline in GFR was significantly greater with warfarin ( -3.68 0.24 ml/min ) compared with DE 110 mg ( -2.57 0.24 ml/min ; p = 0.0009 vs. warfarin ) and DE 150 mg ( -2.46 0.23 ml/min ; p = 0.0002 vs. warfarin ) .
-RESULTS	A decrease in GFR > 25 % was less likely with DE 110 mg ( hazard ratio : 0.81 [ 95 % confidence interval : 0.69 to 0.96 ] ; p = 0.017 ) or DE 150 mg ( hazard ratio : 0.79 [ 95 % confidence interval : 0.68 to 0.93 ] ; p = 0.0056 ) than with warfarin in the observation period > 18 months .
-RESULTS	Patients with poor international normalized ratio control ( i.e. , time in therapeutic range < 65 % ) exhibited a faster decline in GFR .
-RESULTS	A more pronounced decline in GFR was associated with previous warfarin use and with the presence of diabetes .
-CONCLUSIONS	Patients with atrial fibrillation receiving oral anticoagulation exhibited a decline in renal function that was greater in those taking warfarin versus DE , and it was amplified by diabetes and previous vitamin K antagonist use .
-CONCLUSIONS	( Randomized Evaluation of Long Term Anticoagulant Therapy [ RE-LY ] With Dabigatran Etexilate ; NCT00262600 ) .
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-###25426808
-OBJECTIVE	Combination antiretroviral therapy ( ART ) is now the global standard for HIV-infected pregnant and breastfeeding women at all CD4 cell counts .
-OBJECTIVE	We compared the efficacy and safety of an efavirenz versus lopinavir/ritonavir regimen for HIV-infected pregnant women initiating ART in rural Uganda .
-METHODS	Randomized clinical trial .
-METHODS	We performed a planned secondary analysis comparing viral load suppression ( HIV-1 RNA 400 copies/ml ) , safety , and HIV transmission to infants in a trial designed to test the hypothesis that lopinavir/ritonavir versus efavirenz-based ART would reduce placental malaria ( PROMOTE , ClinicalTrials.gov , NCT00993031 ) .
-METHODS	HIV-infected , ART-naive pregnant women at 12-28 weeks gestation and any CD4 cell count were randomized .
-METHODS	ART was provided and participants were counseled to breastfeed for 1 year postpartum .
-RESULTS	The median age of the 389 study participants was 29 years ; median CD4 cell count was 370 cells/l .
-RESULTS	At delivery , virologic suppression was 97.6 % in the efavirenz arm and 86.0 % in the lopinavir/ritonavir arm ( P < 0.001 ) .
-RESULTS	At 48 weeks postpartum , 91.0 % of women on efavirenz and 88.4 % on lopinavir/ritonavir had viral suppression ( P = 0.49 ) .
-RESULTS	Grade 1 or 2 gastrointestinal adverse events were higher among women on lopinavir/ritonavir versus efavirenz .
-RESULTS	Only two infants acquired HIV ( both in the lopinavir/ritonavir arm ) , and HIV-free infant survival was similar between study arms : 92.9 % ( lopinavir/ritonavir ) versus 97.2 % ( efavirenz ) ( P = 0.10 ) .
-CONCLUSIONS	Virologic suppression at delivery was higher with an efavirenz versus lopinavir/ritonavir-based regimen .
-CONCLUSIONS	However , women in both arms achieved high levels of virologic suppression through 1 year postpartum and the risk of transmission to infants was low .
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-###24699939
-OBJECTIVE	The safety and efficacy of sirukumab , an anti-interleukin-6 ( IL-6 ) monoclonal antibody , were evaluated in a 2-part , placebo-controlled phase II study of patients with active rheumatoid arthritis ( RA ) despite methotrexate therapy .
-METHODS	In Part A ( proof-of-concept ) , 36 patients were randomised to placebo or sirukumab 100mg every 2weeks ( q2w ) through week 10 , with crossover treatment during weeks 12-22 .
-METHODS	In Part B ( dose finding ) , 151 patients were randomised to sirukumab ( 100mg q2w , 100mg q4w , 50mg q4w , or 25mg q4w ) through week 24 , or placebo through week 10 with crossover to sirukumab 100mg q2w ( weeks 12-24 ) .
-METHODS	The proportion of patients with an American College of Rheumatology 50 ( ACR50 ) response and the change from baseline in the 28-joint count disease activity score using C-reactive protein ( DAS28-CRP ) were determined .
-METHODS	Safety was evaluated through week 38 in both parts .
-RESULTS	The primary endpoint ( ACR50 at week 12 in Part B ) was achieved only with sirukumab 100mg q2w versus placebo ( 26.7 % vs 3.3 % ; p = 0.026 ) .
-RESULTS	Greater improvements in mean DAS28-CRP at week 12 were observed with sirukumab 100mg q2w versus placebo in Parts A ( 2.1 vs 0.6 , p < 0.001 ) and B ( 2.2 vs 1.1 ; p < 0.001 ) .
-RESULTS	The incidence of adverse events ( AEs ) was similar for sirukumab-treated and placebo-treated patients through week 12 in Part A ( 70.6 % and 63.2 % , respectively ) and B ( 67.8 % and 66.7 % , respectively ) .
-RESULTS	Infections were the most common type of AE ; one death occurred ( Part B , sirukumab 100mg q2w , brain aneurysm ) .
-CONCLUSIONS	Sirukumab-treated patients experienced improvements in the signs/symptoms of RA .
-CONCLUSIONS	Safety results through 38weeks were consistent with other IL-6 inhibitors .
-BACKGROUND	NCT00718718 .
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-###24436355
-OBJECTIVE	To evaluate the validity of the Yo-Yo Intermittent Recovery Test Level 1 ( YYIR1 ) for the direct assessment and the indirect estimation of maximal oxygen consumption ( VO2max ) in female soccer players compared with a maximal laboratory treadmill test ( LTT ) .
-METHODS	Eighteen female soccer players ( 21.5 3.4 y , 165.6 7.5 cm , 63.3 7.4 kg ; mean SD ) completed an LTT and a YYIR1 in random order ( 1 wk apart ) .
-METHODS	Their VO2max was directly measured via portable spirometry during both tests and indirectly estimated from a published non-gender-specific formula ( YYIR1-F1 ) .
-RESULTS	The measured VO2max values in LTT and YYIR1 were 55.0 5.3 and 49.9 4.9 mL kg-1 min-1 , respectively , while the estimated VO2max values from YYIR1-F1 corresponded to 45.2 3.4 mL kg-1 min-1 .
-RESULTS	Large positive correlations between the VO2max values from YYIR1 and LTT ( r = .83 , P < .001 , 90 % confidence interval = .64 -.92 ) and YYIR1-F1 and LTT ( r = .67 , P = .002 , .37 -.84 ) were found .
-RESULTS	However , the YYIR1 significantly underestimated players ' VO2max by 9.4 % compared with LTT ( P < .001 ) with Bland-Altman 95 % limits of agreement ranging from -20.0 % to 1.4 % .
-RESULTS	A significant underestimation from the YYIR1-F1 ( P < .001 ) was also identified ( 17.8 % with Bland-Altman 95 % limits of agreement ranging from -31.8 % to -3.8 % ) .
-CONCLUSIONS	The YYIR1 and YYIR1-F1 are not accurate methods for the direct assessment or indirect estimation of VO2max in female soccer players .
-CONCLUSIONS	The YYIR1-F1 lacks gender specificity , which might have been the reason for its larger error .
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-###24622415
-BACKGROUND	An improper balance of regulatory/effector T ( Treg/Teff ) cells is central to the development of autoimmune diseases , including type 1 diabetes .
-BACKGROUND	We previously showed that low-dose interleukin 2 ( IL2 ) induced Treg cell expansion and activation and clinical improvement in patients with hepatitis-C-virus-induced vasculitis .
-BACKGROUND	We aimed to establish which low doses of IL2 would be safe and induce Treg cells in patients with type 1 diabetes , considering that : ( 1 ) type 1 diabetes might be linked to alteration of the IL2/IL2R activation pathway ; ( 2 ) activation of pathogenic Teff cells by IL2 could exacerbate disease ; and ( 3 ) the safety of low-dose IL2 is not known in type 1 diabetes .
-METHODS	This was a single-centre phase 1/2 study .
-METHODS	24 adult patients ( 18-55 years ) with established insulin-dependent type 1 diabetes and at least one diabetes-related autoantibody were enrolled and randomly assigned ( in a 1:1:1:1 ratio , by computer-generated randomisation list , with block size four ) to placebo or IL2 at 0.33 MIU/day , 1 MIU/day , or 3 MIU/day for a 5-day course and were followed up for 60 days .
-METHODS	All investigators and participants were masked to assignment .
-METHODS	The primary outcome was change in Treg cells , measured by flow cytometry , and expressed as a percentage of CD4 + T cells , from day 1 to day 60 .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT01353833 .
-RESULTS	Six patients were assigned to each group between June 1 , 2011 , and Feb 3 , 2012 .
-RESULTS	IL2 was well tolerated at all doses , with no serious adverse events .
-RESULTS	However , there was a dose-response association for non-serious adverse events during the treatment phase ( days 1-6 ) ; one patient in the placebo group , three patients in the 0.33 MIU group , five patients in the 1 MIU group , and six patients in the 3 MIU group had non-serious adverse events .
-RESULTS	The most common adverse events in the treatment phase were injection-site reaction ( no patients with placebo vs three patients with 0.33 MIU and 1 MIU vs two patients with 3 MIU ) and influenza-like syndrome ( no patients with placebo vs one patient with 0.33 MIU and 1 MIU vs four patients with 3 MIU ) .
-RESULTS	After the treatment phase , adverse events did not differ between groups .
-RESULTS	IL2 did not induce deleterious changes in glucose-metabolism variables .
-RESULTS	IL2 induced a dose-dependent increase in the proportion of Treg cells , significant at all doses compared with placebo ( placebo mean increase 0.5 % [ SD 0.4 ] ; 0.33 MIU 2.8 % [ 1.2 ] , p = 0.0039 ; 1 MIU 3.9 % [ 1.8 ] , p = 0.0039 ; 3 MIU 4.8 % [ 1.9 ] p = 0.0039 ) .
-CONCLUSIONS	We have defined a well-tolerated and immunologically effective dose range of IL2 for application to type 1 diabetes therapy and prevention , which could be relevant to other disorders in which a Treg cell increase would be desirable .
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-###24754230
-OBJECTIVE	The objective of this research was to compare the effects of different causal attributions for overweight and obesity , among individuals with overweight and obesity , on weight-related beliefs , stigmatising attitudes and policy support .
-METHODS	In Study 1 , an online sample of 95 US adults rated the extent to which they believed various factors caused their own weight status .
-METHODS	In Study 2 , 125 US adults read one of three randomly assigned online passages attributing obesity to personal responsibility , biology , or the ` food environment . '
-METHODS	All participants in both studies were overweight or obese .
-METHODS	All participants reported beliefs about weight loss , weight-stigmatising attitudes , and support for obesity-related policies .
-RESULTS	In Study 1 , biological attributions were associated with low weight-malleability beliefs and blame , high policy support , but high internalised weight bias .
-RESULTS	` Food environment ' attributions were not associated with any outcomes , while ` personal responsibility ' attributions were associated with high prejudice and blame .
-RESULTS	In Study 2 , participants who received information about the food environment reported greater support for food-related policies and greater self-efficacy to lose weight .
-CONCLUSIONS	Emphasising the role of the food environment in causing obesity may promote food policy support and health behaviours without imposing the negative consequences associated with other attributions .
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-###24694949
-BACKGROUND	The aim of this study was to evaluate the impact of Quality and Outcomes Framework ( QOF ) , a major pay-for-performance programme in the United Kingdom , on prescribing of long-acting reversible contraceptives ( LARC ) in primary care .
-METHODS	Negative binomial interrupted time series analysis using practice level prescribing data from April 2007 to March 2012 .
-METHODS	The main outcome measure was the prescribing rate of long-acting reversible contraceptives ( LARC ) , including hormonal and non hormonal intrauterine devices and systems ( IUDs and IUSs ) , injectable contraceptives and hormonal implants .
-RESULTS	Prescribing rates of Long-Acting Reversible Contraception ( LARC ) were stable before the introduction of contraceptive targets to the QOF and increased afterwards by 4 % annually ( rate ratios = 1.04 , 95 % CI = 1.03 , 1.06 ) .
-RESULTS	The increase in LARC prescribing was mainly driven by increases in injectables ( increased by 6 % annually ) , which was the most commonly prescribed LARC method .
-RESULTS	Of other types of LARC , the QOF indicator was associated with a step increase of 20 % in implant prescribing ( RR = 1.20 , 95 % CI = 1.09 , 1.32 ) .
-RESULTS	This change is equivalent to an additional 110 thousand women being prescribed with LARC had QOF points not been introduced .
-CONCLUSIONS	Pay for performance incentives for contraceptive counselling in primary care with women seeking contraceptive advice has increased uptake of LARC methods .
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-###24514431
-OBJECTIVE	To investigate the efficacy and safety of sedation with dexmedetomidine in upper gastrointestinal endoscopy .
-METHODS	Patients with ASA physical status I-II undergoing elective upper gastrointestinal endoscopy were randomly allocated to receive dexmedetomidine or midazolam for conscious sedation .
-METHODS	Continuous peripheral oxygen saturation ( SpO2 ) , heart rate , mean arterial pressure ( MAP ) , Ramsay Sedation Scale ( RSS ) and numeric rating scale pain scores were recorded before , during and after the procedure .
-METHODS	Patients completed a post-procedure satisfaction questionnaire .
-RESULTS	Patients in the midazolam group ( n = 30 ) experienced a significant decrease in MAP during sedation compared with pre-sedation values .
-RESULTS	Patients in the dexmedetomidine group ( n = 30 ) had significantly higher SpO2 and RSS scores during sedation than those in the midazolam group .
-RESULTS	Overall satisfaction was higher in the dexmedetomidine group than the midazolam group .
-RESULTS	There were no clinically significant complications in either group .
-CONCLUSIONS	Dexmedetomidine has a good safety profile and is an effective sedative for use in upper gastrointestinal endoscopy .
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-###24524399
-OBJECTIVE	To evaluate the sedation and analgesia power and security of sufentanil in intensive care unit ( ICU ) , and to compare the effect with fentanyl .
-METHODS	A multicenter randomized controlled trial was conducted .
-METHODS	Critical adult patients in ICU from 11 hospitals in Henan Province from June 2011 to January 2012 who needed analgesia based sedation were enrolled .
-METHODS	These patients were randomly divided into two groups with 300 cases in each group using the envelope method according to the hospital number and time sequence number of inclusion .
-METHODS	Exclusion criteria included the time of analgesia duration < 48 hours and who were under continuous renal replacement therapy ( CRRT ) treatment during analgesia .
-METHODS	544 cases were enrolled finally , and there were 282 cases in sufentanil group and 262 in fentanyl group .
-METHODS	Before using the drug , there was no statistically significant difference in age , body weight , acute physiology and chronic health evaluation II ( APACHEII ) score , Glasgow coma scale ( GCS ) between sufentanil group and fentanyl group , and were comparable .
-METHODS	The goal of analgesia was faces pain scale ( FPS ) 2 .
-METHODS	If the dosage of sufentanil and fentanyl exceeded the upper limited dose ( sufentanil 0.3 gkg ( -1 ) h ( -1 ) , fentanyl 2 gkg ( -1 ) h ( -1 ) ) but FPS could not meet ( still > 2 ) , and maintained the upper limited doses of sufentanil and fentanyl and added midazolam , and FPS2 or Ramsay 3 could meet the standard .
-METHODS	The analgesia duration of all cases was 48-168 hours .
-METHODS	Related data were collected for statistical analysis .
-RESULTS	( 1 ) Compared with the data before the analgesia , the mean arterial pressure ( MAP ) of sufentanil analgesia after analgesia at different time points were significantly decreased ( F = 6.061 , P < 0.001 ) and closed to the normal level , FPS at different time point score were decreased significantly after analgesia ( F = 259.389 , P < 0.001 ) , and the changes in pulse oxygen saturation ( SpO ( 2 ) ) , respiratory rate and pulse were not found .
-RESULTS	( 2 ) Compared with before the analgesia , the white blood cell count ( WBC ) , neutrophil percentage ( N ) , platelet count ( PLT ) , aspartate transaminase ( AST ) , creatinine ( Cr ) , arterial partial pressure of carbon dioxide ( PaCO ( 2 ) ) , blood lactic acid , blood sugar , C-reactive protein ( CRP ) were markedly reduced after sufentanil analgesia ( WBC : 10.8 4.2 10 ( 9 ) / L vs. 14.2 11.510 ( 9 ) / L , F = 49.879 , P < 0.001 ; N : 0.806 0.104 vs. 0.815 0.128 , F = 5.768 , P = 0.017 ; PLT : 160.4 77.0 10 ( 9 ) / L vs. 166.1 89.010 ( 9 ) / L , F = 6.568 , P = 0.011 ; AST : 61.3 10.1 U/L vs. 90.9 26.9 U/L , F = 6.706 , P = 0.010 ; Cr : 86.7 71.8 mol/L vs. 119.6 56.0 mol/L , F = 30.303 , P < 0.001 ; PaCO ( 2 ) : 39.4 7.2 mmHg vs. 41.7 22.6 mmHg , F = 4.389 , P = 0.037 ; blood lactic acid : 1.9 1.2 mmol/L vs. 2.7 2.5 mmol/L , F = 4.883 , P = 0.028 ; blood sugar : 8.0 5.4 mmol/L vs. 9.7 7.6 mmol/L , F = 9.724 , P = 0.002 ; CRP : 64.8 20.7 mg/L vs. 114.0 55.9 mg/L , F = 4.883 , P = 0.028 ) .
-RESULTS	But there were no statistically significant differences in red blood cell count ( RBC ) , prothrombin time ( PT ) , activated partial thromboplastin time ( APTT ) , fibrinogen ( FIB ) , thrombin time ( TT ) , alanine aminotransferase ( ALT ) , total bilirubin ( TBil ) , albumin ( ALB ) , total protein ( TP ) blood urea nitrogen ( BUN ) , and arterial partial pressure of oxygen ( PaO ( 2 ) ) before and after sufentanil analgesia ( all P > 0.05 ) .
-RESULTS	( 3 ) There was no statistically significant difference in effectiveness of sufentanil and five times dose of fentanyl ( P > 0.05 ) .
-RESULTS	There was no statistically significant difference in the proportion of sedative drugs midazolam usage [ 18.4 % ( 52/282 ) vs. 24.8 % ( 65/262 ) , ( 2 ) = 1.151 , P = 0.283 ] and the rate of analgesia success [ 44.3 % ( 125/282 ) vs. 48.9 % ( 128/262 ) , ( 2 ) = 0.571 , P = 0.450 ] and analgesia success [ 16.3 % ( 46/282 ) vs. 15.3 % ( 40/262 ) , ( 2 ) = 0.066 , P = 0.798 ] between sufentanil and fentanyl group .
-RESULTS	( 4 ) Comparison of adverse reactions : the incidence of hypotension in sufentanil group was significantly lower than that in fentanyl group [ 3.2 % ( 9/282 ) vs. 6.9 % ( 18/262 ) , ( 2 ) = 3.900 , P = 0.048 ] , and other common adverse reactions , such as respiratory depression/pause , nausea/vomiting and dizziness , pruritus , allergy , slow heart beat ( bradycardia ) and metabolic reactions had no statistically significant difference .
-RESULTS	Addiction or tetanus of skeletal muscles was not found in both groups .
-CONCLUSIONS	Compared with fentanyl , the analgesia efficacy of sufentanil is stronger .
-CONCLUSIONS	Sufentanil has less physiological interference and lower incidence of adverse reactions for ICU patients .
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-###24447332
-BACKGROUND	After 9/11/2001 , most FDNY workers had persistent lung function decline but some exposed workers recovered .
-BACKGROUND	We hypothesized that the protease/anti-protease balance in serum soon after exposure predicts subsequent recovery .
-METHODS	We performed a nested case-control study measuring biomarkers in serum drawn before 3/2002 and subsequent forced expiratory volume at one second ( FEV1 ) on repeat spirometry before 3/2008 .
-METHODS	Serum was assayed for matrix metalloproteinases ( MMP-1 ,2,3,7,8,9,12 and 13 ) and tissue inhibitors of metalloproteinases ( TIMP-1 ,2,3,4 ) .
-METHODS	The representative sub-cohort defined analyte distribution and a concentration above 75th percentile defined elevated biomarker expression .
-METHODS	An FEV1 one standard deviation above the mean defined resistance to airway injury .
-METHODS	Logistic regression was adjusted for pre-9 / 11 FEV1 , BMI , age and exposure intensity modeled the association between elevated biomarker expression and above average FEV1 .
-RESULTS	FEV1 in cases and controls declined 10 % of after 9/11/2001 .
-RESULTS	Cases subsequently returned to 99 % of their pre-exposure FEV1 while decline persisted in controls .
-RESULTS	Elevated TIMP-1 and MMP-2 increased the odds of resistance by 5.4 and 4.2 fold while elevated MMP-1 decreased it by 0.27 fold .
-CONCLUSIONS	Resistant cases displayed healing , returning to 99 % of pre-exposure values .
-CONCLUSIONS	High TIMP-1 and MMP-2 predict healing .
-CONCLUSIONS	MMP/TIMP balance reflects independent pathways to airway injury and repair after WTC exposure .
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-###24387842
-BACKGROUND	Postoperative shivering is a frequent complication of surgery in developing countries and there is no satisfying method to treat it , letalone to cure it .
-BACKGROUND	We studied whether intravenous amino acid ( AA ) infusion can cure postoperative shivering in the postanesthesia care unit .
-METHODS	Sixty postanesthesia care unit patients with shivering grade 2 or higher and tympanic temperature < 36C received randomly either infusion of Novamin 18 AAs ( 2 mL/kg/h ) , pethidine ( 0.5 mg/kg ) , or tramadol ( 1 mg/kg ) .
-METHODS	Tympanic temperature , shivering grade , and thermal comfort were assessed every 5min for 60min .
-METHODS	Blood glucose and lactic acid concentrations were measured before and after treatment .
-METHODS	Postoperative nausea and vomiting were also recorded .
-RESULTS	Shivering stopped within 5min in the pethidine and tramadol groups versus 90 % stopped within 15min in AA group .
-RESULTS	There were five cases of reshivering in the tramadol group versus none in the AA or pethidine groups .
-RESULTS	Tympanic temperature increased slowly in all patients but increased significantly faster in the AA group .
-RESULTS	Thermal comfort improved significantly faster in the AA group versus the other two groups , thermal comfort was significantly higher in the tramadol versus the pethidine group 35min .
-RESULTS	Blood glucose concentration in AA group increased to 135.189.18 mg/dL .
-RESULTS	There were some cases of nausea and vomiting in pethidine and tramadol groups but none in the AA group .
-CONCLUSIONS	Novamin infusion can stop postoperative shivering and alleviates hypothermia and improves thermal comfort more effectively than tramadol and pethidine with less nausea and vomiting and causes a clinically acceptable blood glucose increase with no reshivering episodes .
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-###25617561
-BACKGROUND	Inflammation is one of the main contributory factors to the etiopathogenesis of multiple sclerosis ( MS ) .
-BACKGROUND	Dietary interventions with Lipia citriadora ( lemon verbena ) extracts have been proved to be effective in the prevention of inflammatory diseases .
-OBJECTIVE	The aim of this study is to evaluate the effect of lemon verbena supplementation in pro- and anti- inflammatory serum biomarkers of patients with different clinical subtypes of multiple sclerosis .
-METHODS	The effect of lemon verbena supplementation ( 10 % w/w verbascoside ) was evaluated in a randomized , double-blinded placebo-controlled study with 30 participants classified in relapsing-remitting ( n = 10 ) , primary progressive ( n = 5 ) and secondary progressive ( n = 15 ) MS presentations .
-METHODS	Serum cytokine and C reactive protein levels were assessed in intervention and control groups for each MS clinical subtype after 28 days of dietary supplementation .
-RESULTS	Serum levels of C reactive protein and 8 cytokines / inflammatory ( IFN - , IL-12 , IL-23 , IL-6 , TNF - , TGF - , IL-4 and IL-10 ) markers were studied .
-RESULTS	Secondary progressive MS - supplemented patients showed C reactive protein concentrations significantly lower compared to the placebo group ( p.
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-###25562774
-BACKGROUND	Most diabetic and hypertensive patients , principally the elderly , do not achieve adequate disease control and consume 5 % -15 % of annual health care budgets .
-BACKGROUND	Previous studies verified that pharmaceutical care is useful for achieving adequate disease control in diabetes and hypertension .
-OBJECTIVE	To evaluate the economic cost and the incremental cost-effectiveness ratio ( ICER ) per quality-adjusted life-year ( QALY ) of pharmaceutical care in the management of diabetes and hypertension in elderly patients in a primary public health care system in a developing country .
-METHODS	A 36-month randomized controlled clinical trial was performed with 200 patients who were divided into a control group ( n = 100 ) and an intervention group ( n = 100 ) .
-METHODS	The control group received the usual care offered by the Primary Health Care Unit ( medical and nurse consultations ) .
-METHODS	The intervention group received the usual care plus a pharmaceutical care intervention .
-METHODS	The intervention and control groups were compared with regard to the direct costs of health services ( i.e. , general practitioner , specialist , nurse , and pharmacist appointments ; emergency room visits ; and drug therapy costs ) and the ICER per QALY .
-METHODS	These evaluations used the health system perspective .
-RESULTS	No statistically significant difference was found between the intervention and control groups in total direct health care costs ( $ 281.97 $ 49.73 per patient vs. $ 212.28 $ 43.49 per patient , respectively ; P = 0.089 ) ; pharmaceutical care added incremental costs of $ 69.60 ( $ 7.90 ) per patient .
-RESULTS	The ICER per QALY was $ 53.50 ( 95 % CI = $ 51.60 - $ 54.00 ; monetary amounts are given in U.S. dollars ) .
-RESULTS	Every clinical parameter evaluated improved for the pharmaceutical care group , whereas these clinical parameters remained unchanged in the usual care group .
-RESULTS	The difference in differences ( DID ) tests indicated that for each clinical parameter , the patients in the intervention group improved more from pre to post than the control group ( P < 0.001 ) .
-CONCLUSIONS	While pharmaceutical care did not significantly increase total direct health care costs , significantly improved health outcomes were seen .
-CONCLUSIONS	The mean ICER per QALY gained suggests a favorable cost-effectiveness .
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-###25209306
-BACKGROUND	One important public health issue associated with opioid use today is the risk of hepatitis C ( HCV ) infection .
-BACKGROUND	Although methadone maintenance may help to decrease HCV-related risk practices , HCV risk behaviors persist and are strongly associated with specific substance use patterns , mental status and social context .
-BACKGROUND	The ANRS-Methaville study gave us the opportunity to better disentangle the different relationships between these various factors and HCV risk practices .
-METHODS	The ANRS-Methaville multisite randomized trial was designed to assess the feasibility of initiating methadone in primary care by comparing it with methadone initiation in specialized centers .
-METHODS	This study recruited 195 participants initiating methadone maintenance and followed up for 12months .
-METHODS	Longitudinal data from this trial was used to acquire a greater understanding of HCV risk practices and their pattern of correlates in this population .
-METHODS	We selected 176 patients who had data on HCV risk practices at M0 and M12 , accounting for 312 visits .
-METHODS	HCV risk practices were defined as follows : sharing needles or syringes , sharing drug paraphernalia , getting a tattoo or having a piercing in a non-professional context , sharing toiletry items .
-METHODS	To identify factors associated with HCV risk practices , we performed a mixed logistic regression analysis .
-RESULTS	HCV risk practices were reported by 19 % and 15 % of participants at baseline and M12 , respectively .
-RESULTS	After adjustment for age , cocaine use and alcohol dependence as well as suicidal risk , living in a couple with a non-drug user and in a couple with a drug user were both independent predictors of HCV risk practices ( OR [ CI95 % ] = 4.16 [ 1.42-12 .12 ] ; OR [ CI95 % ] = 9.85 [ 3.13-31 .06 ] , respectively ) .
-CONCLUSIONS	Identifying individuals at risk of HCV transmission during methadone treatment such as stimulant users , alcohol dependent individuals , and those at suicidal risk is necessary to optimize response to treatment .
-CONCLUSIONS	Innovative prevention approaches tailored to couples are also urgently needed and could decrease HCV-risk in this population .
-CONCLUSIONS	The trial is registered with the French Agency of Pharmaceutical Products ( ANSM ) under the number 2008-A0277-48 , the European Union Drug Regulating Authorities Clinical Trials .
-CONCLUSIONS	Number Eudract 2008-001338-28 , the ClinicalTrials.gov Identifier : NCT00657397 and the International Standard Randomised Controlled Trial Number Register ISRCTN31125511 .
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-###26374429
-BACKGROUND	National Surgical Adjuvant Breast and Bowel Project R-04 was designed to determine whether the oral fluoropyrimidine capecitabine could be substituted for continuous infusion 5-FU in the curative setting of stage II/III rectal cancer during neoadjuvant radiation therapy and whether the addition of oxaliplatin could further enhance the activity of fluoropyrimidine-sensitized radiation .
-METHODS	Patients with clinical stage II or III rectal cancer undergoing preoperative radiation were randomly assigned to one of four chemotherapy regimens in a 2x2 design : CVI 5-FU or oral capecitabine with or without oxaliplatin .
-METHODS	The primary endpoint was local-regional tumor control .
-METHODS	Time-to-event endpoint distributions were estimated using the Kaplan-Meier method .
-METHODS	Hazard ratios were estimated from Cox proportional hazard models .
-METHODS	All statistical tests were two-sided .
-RESULTS	Among 1608 randomized patients there were no statistically significant differences between regimens using 5-FU vs capecitabine in three-year local-regional tumor event rates ( 11.2 % vs 11.8 % ) , 5-year DFS ( 66.4 % vs 67.7 % ) , or 5-year OS ( 79.9 % vs 80.8 % ) ; or for oxaliplatin vs no oxaliplatin for the three endpoints of local-regional events , DFS , and OS ( 11.2 % vs 12.1 % , 69.2 % vs 64.2 % , and 81.3 % vs 79.0 % ) .
-RESULTS	The addition of oxaliplatin was associated with statistically significantly more overall and grade 3-4 diarrhea ( P < .0001 ) .
-RESULTS	Three-year rates of local-regional recurrence among patients who underwent R0 resection ranged from 3.1 to 5.1 % depending on the study arm .
-CONCLUSIONS	Continuous infusion 5-FU produced outcomes for local-regional control , DFS , and OS similar to those obtained with oral capecitabine combined with radiation .
-CONCLUSIONS	This study establishes capecitabine as a standard of care in the pre-operative rectal setting .
-CONCLUSIONS	Oxaliplatin did not improve the local-regional failure rate , DFS , or OS for any patient risk group but did add considerable toxicity .
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-###24440105
-OBJECTIVE	To compare the safety and efficacy of Ozil Intelligent Phaco torsional microcoaxial phacoemulsification surgeries performed using 30-degree and 45-degree aperture angled tips .
-METHODS	Maltepe University School of Medicine Department of Ophthalmology , Istanbul , Turkey .
-METHODS	Comparative case series .
-METHODS	Eyes were assigned to 2.2 mm microcoaxial phacoemulsification using the torsional mode with a 45-degree ( Group 1 ) or 30-degree ( Group 2 ) aperture angled tip .
-METHODS	A quick-chop surgical technique was used .
-METHODS	The primary outcome measures were ultrasound time ( UST ) , cumulative dissipated energy ( CDE ) , longitudinal and torsional ultrasound ( US ) amplitudes , mean surgical time , mean balanced salt solution volume used , and mean central corneal thickness ( CCT ) changes .
-RESULTS	The mean UST , CDE , and longitudinal and torsional US amplitudes were 58.21 seconds 33.81 ( SD ) , 7.74 6.23 , 0.45 0.30 , and 26.30 12.60 in Group 1 and 63.83 23.42 seconds , 12.36 6.75 , 0.23 0.26 , and 44.65 14.38 in Group 2 , respectively .
-RESULTS	The mean CDE and torsional amplitudes were significantly lower in Group 1 ( P = .002 and P = .001 , respectively ) .
-RESULTS	The mean balanced salt solution volume was 73.30 19.87 cc in Group 1 and 74.30 19.44 cc in Group 2 ( P = .821 ) .
-RESULTS	The mean CCT change was 52.40 38.08 m and 99.35 47.14 m , respectively ( P < .001 ) .
-CONCLUSIONS	Torsional phacoemulsification performed with a 45-degree aperture angled tip provided more effective lens removal with a lower CDE and less CCT change than a 30-degree aperture angled tip .
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-###24730623
-OBJECTIVE	To evaluate the intra-operative and postoperative outcome of paediatric cataract surgery with primary posterior capsulotomy ( PPC ) and anterior vitrectomy using intra-operative preservative-free triamcinolone acetonide .
-METHODS	In this prospective , interventional case-control study , 20 Children who underwent cataract surgery for both eyes were enrolled and their eyes were randomized into two groups .
-METHODS	Group A consists of 20 eyes in which standard phacoaspiration with PPC with intracameral triamcinolone was used , and Group B consists of 20 eyes in which triamcinolone were not used .
-METHODS	Intra-operative complications and postoperative outcome like intraocular pressure ( IOP ) , posterior synechiae , pigment deposits and posterior capsule opacification ( PCO ) were studied .
-RESULTS	In both groups , age range varied between 2-8 years comprising 18 males and two females .
-RESULTS	The mean postoperative IOP did not show any significant variation during 6-month follow-up .
-RESULTS	In study group , all the 20 eyes were quiet at 2 weeks , while there was cellular reaction 1 + in four eyes ( 20 % ) and nil in 16 eyes ( 80 % ) at 2 week in the control group ( p = 0.035 ) .
-RESULTS	Pigment deposits on IOL optic was seen in two eyes ( 10 % ) of the study group while in control group , IOL deposits were present in 14 eyes ( 70 % ) ( p = 0.001 ) .
-RESULTS	Posterior capsule opacification was seen in two eyes ( 10 % ) in control group at 3 months while none occurred in study group .
-CONCLUSIONS	Intra-operative use of preservative-free triamcinolone acetonide led to less anterior chamber inflammation and pigment deposits on IOL optic postoperatively compared to those eyes where it was not used .
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-###24944264
-OBJECTIVE	To determine whether allopregnanolone ( AP ) may mediate seizure reduction in progesterone-treated women with epilepsy .
-METHODS	The NIH Progesterone Trial compared the efficacy of adjunctive cyclic natural progesterone therapy vs placebo treatment of intractable seizures in 294 subjects , randomized 2:1 to progesterone or placebo , stratified by catamenial vs noncatamenial designation .
-METHODS	Treatments were compared on proportions of 50 % responders , and changes in seizure frequency from 3 baseline to 3 treatment cycles .
-METHODS	Serum AP levels were measured by radioimmunoassay from 155 women with intractable focal-onset seizures who had baseline and treatment-phase midluteal serum samples drawn each cycle for hormone measurements .
-RESULTS	There was no significant correlation between percentage changes in AP levels and seizure frequencies from baseline to treatment for either the catamenial or noncatamenial stratum .
-RESULTS	There was a significant correlation for the subset of subjects who showed a significantly greater responder rate in the post hoc analysis of the trial , i.e. , subjects who had a 3-fold or greater increase in average daily seizure frequency perimenstrually compared with the midfollicular and midluteal phases ( C1 3 : r = -0.442 , p = 0.013 , and specifically for C1 3 progesterone-treated subjects [ r = -0.452 , p = 0.035 ] , but not other groups [ C1 3 placebo : r = -0.367 ; C1 < 3 progesterone : r = 0.099 ; C1 < 3 placebo : r = 0.131 ; p = not significant ] ) .
-CONCLUSIONS	The findings support AP as a mediator of seizure reduction in progesterone-treated women who have a substantial level of perimenstrually exacerbated seizures .
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-###24728329
-OBJECTIVE	To compare the relative bioavailability , safety and tolerability of oral methotrexate ( MTX ) and subcutaneous ( SC ) MTX administered via an auto-injector ( MTXAI ) in patients with rheumatoid arthritis ( RA ) .
-METHODS	In this randomised , multicenter , open-label , three-way crossover study , patients 18years with adult RA undergoing treatment with MTX for 3months were assigned to receive MTX 10 , 15 , 20 and 25mg weekly in a random sequence of three treatments : oral , SC into the abdomen and SC into the thigh .
-METHODS	For 24h after administration of each treatment , blood samples were collected for pharmacokinetic analysis and injection sites were assessed .
-RESULTS	Forty-seven patients completed the study .
-RESULTS	Systemic exposure of oral MTX plateaued at doses 15mg/week .
-RESULTS	In contrast , SC MTX demonstrated a linear increase in systemic exposure that was greater than oral MTX at each dose .
-RESULTS	No unexpected AEs were noted for either formulation .
-CONCLUSIONS	Unlike oral MTX , the systemic exposure of SC MTX did not plateau over the doses studied , particularly at doses 15mg/week .
-CONCLUSIONS	In this study , higher systemic MTX exposure was not associated with increases in AEs .
-CONCLUSIONS	Patients with an inadequate clinical response to oral MTX may benefit from higher drug exposure by switching to SC MTX .
-BACKGROUND	NCT01618968 .
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-###24401802
-BACKGROUND	Total knee arthroplasty ( TKA ) is associated with varying degrees of pain .
-BACKGROUND	A considerable proportion ( 25-40 % ) of patients experience severe pain , despite a comprehensive multimodal analgesic regimen .
-BACKGROUND	We hypothesized that adductor canal block ( ACB ) would reduce pain in this patient category compared with placebo .
-METHODS	Fifty patients with severe pain , defined as having a visual analogue scale ( VAS ) pain score of > 60 during active flexion of the knee on the first or the second postoperative day after TKA , were included in this randomized , double-blind , placebo-controlled trial .
-METHODS	All the patients had received a comprehensive multimodal analgesic regimen .
-METHODS	Group A received an ACB with ropivacaine 0.75 % , 30 ml at time 0 and isotonic saline after 45 min .
-METHODS	Group B received an ACB with isotonic saline at time 0 and ropivacaine 0.75 % , 30 ml after 45 min .
-RESULTS	A 32-mm difference in VAS pain score , during active flexion of the knee ( primary endpoint ) , was observed in favour of Group A , 95 % confidence interval ( CI ) : 23-42 , P < 0.0001 .
-RESULTS	At rest , the difference in VAS pain score was 15 mm in favour of Group A , 95 % CI : 8-23 mm , P = 0.0001 .
-RESULTS	Individual patient analysis revealed that 25 % of the patients had no effect during active flexion .
-RESULTS	At rest , however , only 8 % had more than mild pain after ACB compared with 57 % at inclusion .
-CONCLUSIONS	ACB reduced VAS with 32 mm , during active flexion of the knee , in patients with severe pain after TKA , but a large proportion ( 78 % ) still had at least moderate , movement-related pain .
-CONCLUSIONS	Clinical trial registration www.clinicaltrials.gov , NCT01549704 .
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-###24781571
-BACKGROUND	Radial arterial catheterization in pediatric patients is occasionally difficult despite ultrasound guidance .
-BACKGROUND	We therefore assessed the factors affecting catheterization and tested an intervention designed to improve its success .
-METHODS	For initial assessment , we performed multiple logistic regression analyses using 102 pediatric patients .
-METHODS	Dependent variables included first-attempt and overall success or failure ; independent variables were systolic blood pressure , weight , ASA physical status , trisomy 21 , arterial diameter , and subcutaneous depth of the radial artery ( < 2 , 2-4 , 4 mm ) .
-METHODS	The effect of subcutaneous arterial depth on cannulation success was assessed using Kaplan-Meier curves with log-rank and Dunn tests .
-METHODS	We then assessed catheterization success in 60 patients who were randomized to no treatment or subcutaneous saline injection , as necessary , to increase the subcutaneous arterial depth from < 2 to 2 to 4 mm .
-RESULTS	Subcutaneous arterial depth of 2 to 4 mm was derived as a significant independent predictor of initial and overall success from the multiple logistic regression analyses .
-RESULTS	The 2 to 4 mm group had a significantly shorter catheterization time compared with the other 2 groups in the log-rank test ( 2-4 vs < 2 mm group ; P = 0.01 , 2-4 vs 4 mm group ; P < 0.001 ) , and higher success rate in the first attempt ( < 2 [ 43.8 % ] vs 2-4 mm [ 76.9 % ] , P = 0.02 ; 2-4 [ 76.9 % ] vs 4.0 mm [ 19.4 % ] , P < 0.001 ) , and the overall attempt ( < 2 [ 62.5 % ] vs 2-4 mm [ 89.7 % ] , P = 0.04 ; 2-4 [ 89.7 % ] vs 4.0 mm [ 51.6 % ] , P = 0.002 ) .
-RESULTS	Injecting subcutaneous saline to bring arterial depth from < 2 mm to 2 to 4 mm significantly shortened catheterization time ( P = 0.002 ) , and improved the success rate in the first-attempt ( saline injection [ 85.0 % ] vs < 2 mm [ 30.0 % ] , P < 0.001 ) , and the overall attempt ( saline injection [ 90.0 % ] vs < 2 mm [ 55.0 % ] , P = 0.02 ) .
-CONCLUSIONS	Ultrasound-guided radial artery catheterization in pediatric patients was fastest and most reliable when the artery was 2 to 4 mm below the skin surface .
-CONCLUSIONS	For arteries located < 2 mm below the skin surface , increasing the depth to 2 to 4 mm by subcutaneous saline injection reduced catheterization time and improved the success rate .
-
-###25239225
-BACKGROUND	The purpose of this study was to assess the efficacy and safety of trabectedin for advanced breast cancer .
-METHODS	In an open-label , phase II , multicenter study , women with advanced breast cancer previously treated with 2 lines of chemotherapy for advanced disease , including both anthracyclines and taxanes , were randomized ( 1:1 ) to 3-hour infusions of trabectedin 1.3 mg/m ( 2 ) once every 3 weeks ( 1/3 treatment arm ) or 0.58 mg/m ( 2 ) every week for 3 of 4 weeks ( 3/4 treatment arm ) .
-METHODS	The primary end point was objective response .
-METHODS	Secondary end points included time to progression ( TTP ) , progression-free survival ( PFS ) , and overall survival ( OS ) .
-RESULTS	Fifty-two women ( median age , 50 years ; median chemotherapy agents , 4 ) were enrolled .
-RESULTS	Relative trabectedin dose intensities were 81 % and 76 % in the 1/3 and 3/4 treatment arms , respectively .
-RESULTS	Objective response rates were 12 % ( 3 of 25 ) and 4 % ( 1 of 27 ) , respectively .
-RESULTS	Stable disease was observed in 14 ( 56 % ) and 11 ( 41 % ) patients in the 1/3 and 3/4 treatment arms , respectively , with median durations of 3.5 and 3.7 months .
-RESULTS	Median TTP and PFS were higher in the 1/3 treatment arm ( 3.1 months each ) than in the 3/4 treatment arm ( 2.0 months each ) .
-RESULTS	At a median follow-up of 7 months in both treatment arms , median OS was not reached in the 1/3 treatment arm and was 9.4 months in the 3/4 treatment arm .
-RESULTS	The most frequent drug-related adverse events in the 1/3 and 3/4 treatment arms , respectively , were alanine aminotransferase ( ALT ) level increases ( 68 % vs. 63 % ) , nausea ( 56 % vs. 59 % ) , and asthenia ( 56 % vs. 48 % ) .
-RESULTS	Neutropenia and increases in ALT levels were the most frequent grade 3/4 events .
-RESULTS	Both types of events were usually transient and reversible .
-CONCLUSIONS	In the population studied , trabectedin showed a manageable safety profile for both regimens analyzed .
-CONCLUSIONS	There were higher objective response rates and a longer PFS in the 1/3 treatment arm compared with the 3/4 treatment arm .
-
-###26156921
-BACKGROUND	Endotracheal intubation is a method necessary for controlling and maintaining airway during general anesthesia .
-BACKGROUND	Cough and hoarseness are common complications after endotracheal intubation .
-BACKGROUND	Inflammation has an important role in postoperative cough and hoarseness outbreak .
-BACKGROUND	Also it has been stated that green tea has anti-inflammatory properties .
-BACKGROUND	Therefore , the current study has been conducted to investigate green tea gargling solution effect on cough and hoarseness after coronary artery bypass graft ( CABG ) surgery .
-METHODS	In this single-blind , randomized , & controlled clinical trial , we enrolled 121 patients undergoing CABG admitted to the ICU .
-METHODS	The intervention group participants were asked to gargle 30 cc of green tea solution .
-METHODS	The control group patients gargled 30 cc of distilled water .
-METHODS	An hour after extubation , the intervention group patients were asked to gargle 30 cc of green tea and the control group patients were required to gargle 30 cc of distilled water every 6 hour up to 24 hour ( each patient for 4 times ) .
-METHODS	Moreover , the cough and hoarseness questionnaire was also filled in 6 , 12 , and 24 hours after endotracheal extubation .
-RESULTS	The results showed no significant differences among the patients in both groups regarding age , gender , body mass index , smoking history , and anesthesia duration .
-RESULTS	There was a significant difference between the two groups in terms of cough 12 hours after removing the endotracheal tube .
-RESULTS	At other times , there was no significant difference between the two groups considering cough and hoarseness .
-CONCLUSIONS	The present study results showed that green tea gargling does not decrease hoarseness .
-CONCLUSIONS	Though , cough occurrence was less in the intervention group than the other group .
-
-###25157406
-OBJECTIVE	To investigate the genetic influence of 48 type 2 diabetes susceptibility variants on disease progression measured as risk of early prescription redemption of glucose lowering drugs in screen-detected patients with type 2 diabetes .
-METHODS	We studied type 2 diabetes progression in 1,480 patients with screen-detected type 2 diabetes from the ADDITION-Denmark study using information of redeemed prescriptions from the Register of Medicinal Products Statistics from 2001-2009 in Denmark .
-METHODS	Patients were cluster randomized by general practitioners , who were randomized to treat type 2 diabetes according to either a conventional or a multifactorial intensive treatment algorithm .
-METHODS	We investigated the genetic influence on diabetes progression by constructing a genetic risk score ( GRS ) of all 48 validated type 2 diabetes susceptibility variants , a GRS of 11 variants linked to - cell function and a GRS of 3 variants linked to insulin sensitivity and assessed the association between number of risk alleles and time from diagnosis until first redeemed prescription of either any glucose lowering drug or an insulin drug .
-RESULTS	The GRS linked to insulin sensitivity only nominally increased the risk of an early prescription redemption with an insulin drug by 39 % ( HR [ 95 % C.I. ] = 1.39 [ 1.09-1 .77 ] , p = 0.009 ] in patients randomized to the intensive treatment group .
-RESULTS	Furthermore , the strongest univariate predictors of diabetes progression for the intensive treatment group ( measured as time to first insulin ) were younger age ( HR [ 95 % C.I. ] = 0.96 [ 0.93-0 .99 ] ) , increased BMI ( 1.05 [ 1.01-1 .09 ] ) , increased HbA1c ( 1.50 [ 1.36 -.66 ] ) , increased TG ( 1.24 [ 1.11-1 .39 ] ) and reduced fasting serum HDL ( 0.37 [ 0.17-0 .80 ] ) at baseline .
-RESULTS	Similar results were obtained for the conventional treatment group .
-CONCLUSIONS	Higher levels of HbA1c , fasting circulating levels of triglyceride , lower HDL , larger BMI and younger age are significant determinants of early pharmacological intervention in type 2 diabetes .
-CONCLUSIONS	However , known common type 2 diabetes-associated gene variants do not appear to significantly affect disease progression .
-
-###24555499
-OBJECTIVE	To determine optimum duration of intraurethral 2 % lidocaine jelly for pain relief during outpatient rigid cystoscopy .
-METHODS	This prospective randomized study was conducted between June 2012 and November 2013 .
-METHODS	Four hundred consecutive adult males requiring diagnostic rigid cystoscopy were randomized into four groups depending on intraurethral 2 % lidocaine jelly dwell time before rigid cystoscopy : jelly was instilled 5 , 10 , 15 , and 20 minutes before start of the procedure in group A , B , C , and D patients , respectively .
-METHODS	The patients ' age , patient-reported preoperative anxiety score , patient-reported intraoperative pain score , the surgeon-reported patient 's pain score , and the duration of rigid cystoscopy were recorded and analyzed .
-RESULTS	The mean age , patient-reported preoperative anxiety score , and duration of rigid cystoscopy were similar between the four groups with no significant difference noted between them .
-RESULTS	The least and highest mean patient-reported and surgeon-reported intraoperative pain scores were reported in group C ( 1.490.82 and 1.580.67 ) patients and group A ( 4.861.24 and 4.041.11 ) patients , respectively , while no significant difference was found in these scores between group C and D patients .
-CONCLUSIONS	For male patients undergoing diagnostic rigid cystoscopy , an intraurethral dwell time of 15 minutes ( of 20mL 2 % lidocaine jelly ) provided optimum pain relief .
-
-###24755713
-BACKGROUND	The intervention completion rate is an important metric in behavioral and intervention research ; trials with limited intervention completion rates may have reduced internal validity .
-BACKGROUND	We examined intervention completion rates among 530 African Americans who had been randomized to an integrated ( INT ) or disease-specific ( DSE ) risk education protocol as part of a comparative effectiveness trial from September 2009 to August 2012 .
-METHODS	The interventions were developed by an academic-community partnership using community-based participatory research .
-METHODS	Intervention completion rates were determined based on attendance at all four intervention sessions .
-METHODS	Intervention completers were participants who completed all four sessions and noncompleters were those who did not complete any session or only completed one to three sessions following randomization .
-RESULTS	Seventy-three percent of participants were intervention completers and 27 % were noncompleters .
-RESULTS	There were no differences in intervention completion based on randomization to INT ( 72 % ) or DSE ( 75 % ) , sociodemographic factors , or body mass index ( BMI ) in the total sample .
-RESULTS	Different factors were associated significantly with intervention completion within study groups .
-RESULTS	Among participants randomized to INT , the odds of intervention completion were greater with higher levels of intrinsic motivation , less exposure to information about diet and cardiovascular disease , and greater BMI .
-RESULTS	Among participants randomized to DSE , the odds of completing the intervention were associated significantly with older age and greater dietary self-efficacy .
-CONCLUSIONS	Many African Americans are likely to complete risk education interventions .
-CONCLUSIONS	Psychologic characteristics should be considered when determining intervention completion rates following randomization in behavioral and intervention trials .
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-###24581393
-BACKGROUND	The purpose was to determine whether a brachytherapy boost improves outcomes in patients with advanced nasopharyngeal carcinoma treated with standard chemo-radiotherapy .
-METHODS	Patients with nasopharyngeal carcinoma WHO grades I-III and TNM stages III or non-metastatic stage IV were eligible for this phase III study .
-METHODS	Patients were randomized to either arm ( A ) induction chemotherapy , followed by external beam radiotherapy ( EBRT ) with concomitant cisplatin ( n = 139 ) or arm ( B ) , the same schedule plus a brachytherapy boost to the nasopharynx ( n = 135 ) .
-METHODS	The EBRT doses given were 70 Gy to the primary tumour and positive lymph nodes and 46 Gy to the negative neck .
-METHODS	The additional brachytherapy boost in arm ( B ) was given by either low dose-rate ( LDR - 11 Gy ) or high dose-rate ( HDR - 3 fractions of 3.0 Gy ) brachytherapy .
-METHODS	The primary endpoint was 3-year overall survival ( OS ) and secondary endpoints were : local control , regional control , distant metastasis and grade 3-4 adverse events .
-RESULTS	274 patients were randomized between September 2004 and December 2008 .
-RESULTS	The two arms were comparable with regard to age , gender , stage and grade .
-RESULTS	273 patients completed treatment .
-RESULTS	Median follow-up was 29 months ( 0.2-67 months ) .
-RESULTS	The effect of treatment arm , country , age , gender , WHO pathology , stage ( T3-4 , N2-3 versus other ) and chemotherapy on overall survival ( OS ) , disease-free survival ( DFS ) and local recurrence-free survival ( LRFS ) was studied .
-RESULTS	Stage significantly affected OS ( p = 0.024 ) and DFS ( p = 0.018 ) while age significantly affected OS ( p = 0.014 ) .
-RESULTS	None of the other factors studied were significant .
-RESULTS	The 3-year LRFS was 60.5 % and 54.4 % in arms A and B respectively ( p = 0.647 ) .
-RESULTS	The 3-year regional control rate in the neck was 59.7 % and 54.3 % respectively ( p = 0.7 ) .
-RESULTS	Distant metastasis developed in 59.7 % of patients in arm A and 55.4 % in arm B ( p = 0.377 ) .
-RESULTS	Patients with T1/T2 N + had a 3 year LRFS of 51.8 % in Arm A ( 62 patients ) versus 57.9 % in Arm B ( 67 patients ) ( p = 0.343 ) .
-RESULTS	The grade 3-4 toxicity rate was 21.6 % ( 30/139 ) and 24.4 % ( 33/135 ) respectively ( p = 0.687 ) .
-CONCLUSIONS	The addition of a brachytherapy boost to external beam radiotherapy and chemotherapy did not improve outcome in loco-regionally advanced nasopharyngeal carcinoma .
-
-###24629504
-OBJECTIVE	This randomized controlled trial of outpatients with breast cancer ( stage I or II ) evaluated the effects of a 3-week educational intervention on patient levels of fatigue .
-METHODS	Norwegian outpatients were randomized into an intervention group ( n = 79 ) and a control group ( n = 81 ) .
-METHODS	Women with fatigue ( > 2.5 on a 0-10 numeric rating scale , NRS ) completed the Fatigue Questionnaire ( FQ ) and the Lee Fatigue Scale ( LFS ) at baseline ( after treatment ) ( T1 ) , immediately after intervention ( T2 ) and 3 months after intervention ( T3 ) .
-RESULTS	The mean fatigue score ( NRS ) at study entry was 6.1 ( SD 1.7 ) and 36 % ( n = 57 ) had a score 7 .
-RESULTS	There were no statistically significant differences between the fatigue measures of women in the intervention and control group at T2 or T3 in the overall sample after the intervention .
-RESULTS	Using an NRS cut-off of 5 , there was a borderline difference for women who scored < 5 for chronic fatigue on FQ ( p = 0.062 ) and a significant difference for energy on LFS ( p = 0.042 ) where the women in the intervention group had less fatigue .
-RESULTS	Using an NRS cut-off score of 6 , there was a borderline difference for women who scored < 6 for fatigue on FQ ( p = 0.062 ) and a significant difference for energy on LFS ( p = 0.021 ) where women in the intervention group had more energy than those in the control group .
-CONCLUSIONS	Further research is needed to identify psycho-educational interventions to reduce levels of fatigue and to tailor an intervention based on the level of fatigue .
-CONCLUSIONS	Fatigue measurements should be chosen more carefully .
-
-###24286967
-BACKGROUND	Heavy alcohol consumption in HIV patients is an increasing health concern .
-BACKGROUND	Applying the drinking motivational model to HIV primary care patients , drinking motives ( drinking to cope with negative affect , for social facilitation , and in response to social pressure ) were associated with alcohol consumption at a baseline interview .
-BACKGROUND	However , whether these motives predict continued heavy drinking or alcohol dependence in this population is unknown .
-METHODS	Participants were 254 heavy-drinking urban HIV primary care patients ( 78.0 % male ; 94.5 % African American or Hispanic ) participating in a randomized trial of brief drinking-reduction interventions .
-METHODS	Drinking motive scales , as well as measures of alcohol consumption and alcohol dependence , were administered at baseline .
-METHODS	Consumption and dependence measures were re-administered at the end of treatment two months later .
-METHODS	Regression analyses tested whether baseline drinking motive scale scores predicted continued heavy drinking and alcohol dependence status at the end of treatment , and whether motives interacted with treatment condition .
-RESULTS	Baseline drinking to cope with negative affect predicted continued heavy drinking ( p < 0.05 ) and alcohol dependence , the latter in both in the full sample ( adjusted odds ratio [ AOR ] = 2.14 ) and among those with baseline dependence ( AOR = 2.52 ) .
-RESULTS	Motives did not interact with treatment condition in predicting alcohol outcomes .
-CONCLUSIONS	Drinking to cope with negative affect may identify HIV patients needing targeted intervention to reduce drinking , and may inform development of more effective interventions addressing ways other than heavy drinking to cope with negative affect .
-
-###24678937
-BACKGROUND	We compared transcatheter aortic-valve replacement ( TAVR ) , using a self-expanding transcatheter aortic-valve bioprosthesis , with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery .
-METHODS	We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center .
-METHODS	Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors .
-METHODS	Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve ( TAVR group ) or to surgical aortic-valve replacement ( surgical group ) .
-METHODS	The primary end point was the rate of death from any cause at 1 year , evaluated with the use of both noninferiority and superiority testing .
-RESULTS	A total of 795 patients underwent randomization at 45 centers in the United States .
-RESULTS	In the as-treated analysis , the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group ( 14.2 % vs. 19.1 % ) , with an absolute reduction in risk of 4.9 percentage points ( upper boundary of the 95 % confidence interval , -0.4 ; P < 0.001 for noninferiority ; P = 0.04 for superiority ) .
-RESULTS	The results were similar in the intention-to-treat analysis .
-RESULTS	In a hierarchical testing procedure , TAVR was noninferior with respect to echocardiographic indexes of valve stenosis , functional status , and quality of life .
-RESULTS	Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke .
-CONCLUSIONS	In patients with severe aortic stenosis who are at increased surgical risk , TAVR with a self-expanding transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement .
-CONCLUSIONS	( Funded by Medtronic ; U.S. CoreValve High Risk Study ClinicalTrials.gov number , NCT01240902 . )
-
-###25321659
-BACKGROUND	Omega-3 fatty acid supplements have been reported to inhibit exercise-induced bronchoconstriction ( EIB ) .
-BACKGROUND	It has not been determined whether omega-3 supplements inhibit airway sensitivity to inhaled mannitol , a test for bronchial hyperresponsiveness ( BHR ) and model for EIB in people with mild to moderate asthma .
-METHODS	In a double-blind , crossover trial , subjects with asthma who had BHR to inhaled mannitol ( n = 23 ; 14 men ; mean age , 28 years ; one-half taking regular inhaled corticosteroids ) were randomized to omega-3 supplements ( 4.0 g/d eicosapentaenoic acid and 2.0 g/d docosahexaenoic acid ) or matching placebo for 3 weeks separated by a 3-week washout .
-METHODS	The primary outcome was the provoking dose of mannitol ( mg ) to cause a 15 % fall in FEV1 ( PD15 ) .
-METHODS	Secondary outcomes were sputum eosinophil count , spirometry , Asthma Control Questionnaire ( ACQ ) score , serum triacylglyceride level , and lipid mediator profile in urine and serum .
-RESULTS	PD15 ( geometric mean , 95 % CI ) to mannitol following supplementation with omega-3s ( 78 mg , 51-119 mg ) was not different from placebo ( 88 mg , 56-139 mg , P = .5 ) .
-RESULTS	There were no changes in sputum eosinophils ( mean SD ) in a subgroup of 11 subjects ( omega-3 , 8.4 % 8.2 % ; placebo , 7.8 % 11.8 % ; P = .9 ) .
-RESULTS	At the end of each treatment period , there were no differences in FEV1 % predicted ( omega-3 , 85 % 13 % ; placebo , 84 % 11 % ; P = .9 ) or ACQ score ( omega-3 , 1.1 % 0.5 % ; placebo , 1.1 % 0.5 % ; P = .9 ) ( n = 23 ) .
-RESULTS	Omega-3s caused significant lowering of blood triglyceride levels and expected shifts in serum fatty acids and eicosanoid metabolites , confirming adherence to the supplements ; however , no changes were observed in urinary mast cell mediators .
-CONCLUSIONS	Three weeks of omega-3 supplements does not improve BHR to mannitol , decrease sputum eosinophil counts , or inhibit urinary excretion of mast cell mediators in people with mild to moderate asthma , indicating that dietary omega-3 supplementation is not useful in the short-term treatment of asthma .
-BACKGROUND	ClinicalTrials.gov ; No. : NCT00526357 ; URL : www.clinicaltrials.gov .
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-###24311403
-BACKGROUND	Catecholamines and inflammatory mediators , with elevated levels after brain death , are associated with reduced function and survival of transplanted organs .
-BACKGROUND	Enteral nutrition reduces tissue damage and may benefit organs .
-OBJECTIVE	To evaluate the effects of immunomodulating enteral nutrition in organ donors .
-METHODS	Prospective , randomized , open-label study .
-METHODS	Intensive care unit .
-METHODS	Thirty-six brain-dead organ donors .
-METHODS	Donors were randomized to receive enteral nutrition containing omega-3 polyunsaturated fatty acid , antioxidants , and glutamine or standard care ( fasting ) .
-METHODS	Donors received hormonal replacement therapy of corticosteroid , levothyroxine , dextrose , and insulin .
-METHODS	Gastrointestinal assimilation ( measured by 13 carbon-labeled uracil breath analysis ) , quantity of organs recovered , resting energy expenditure , urine level of urea nitrogen , and serum levels of albumin , prealbumin , interleukin 6 , tumor necrosis factor - , and C-reactive protein were evaluated .
-RESULTS	Thirteen patients ( 36 % ) assimilated 13C-labeled uracil .
-RESULTS	Resting energy expenditure was significantly higher than predicted between 10 and 14 hours after baseline in 33 donors ( P = .007 ) .
-RESULTS	Other measures were not conclusively different between fed and fasting groups .
-RESULTS	No adverse events occurred that were related to the enteral feeding .
-CONCLUSIONS	About 30 % of donors metabolized 13C-labeled uracil , although no difference in oxidation rate was found between fasting and fed donors .
-CONCLUSIONS	Corticosteroid administration lowers plasma levels of interleukin 6 and most likely contributes to greater than predicted resting energy expenditure .
-CONCLUSIONS	Thus energy needs may not be met during fasting if hormones are given .
-CONCLUSIONS	Consequences of this possible energy deficit warrant further study .
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-###24666633
-BACKGROUND	Over 45 % of American women 20-39 years old are at risk for type 2 diabetes , cardiovascular disease , and other health conditions because they are overweight or obese .
-BACKGROUND	The prevalence of overweight and obesity is disproportionately high among low-income women .
-BACKGROUND	This paper describes the study design and rationale of a community based intervention ( Mothers In Motion , MIM ) aimed to prevent weight gain among low-income overweight and obese mothers 18-39 years old by promoting stress management , healthy eating , and physical activity .
-METHODS	Peer recruiters approach participants from 5 Special Supplemental Nutrition Program for Women , Infants , and Children ( WIC ) in Michigan .
-METHODS	The MIM delivers theory-based , culturally-sensitive intervention messages via a combination of DVDs and peer support group teleconferences ( PSGTs ) .
-METHODS	The DVD features African American and white overweight and obese WIC mothers who participated in a healthy lifestyle intervention patterned after MIM .
-METHODS	The PSGTs are led by paraprofessionals from Michigan State University Extension and WIC providers in Michigan who are trained in motivational interviewing and group facilitation skills .
-METHODS	Participants are randomly assigned to an intervention ( n = 350 ) or comparison group ( n = 175 ) .
-METHODS	The intervention group receives a 16-week intervention on a weekly or bi-weekly basis .
-METHODS	Participants are asked to watch 10 MIM DVD chapters at home and join 10 PSGT sessions by phone .
-METHODS	The comparison group receives printed educational materials .
-METHODS	The primary outcome is body weight .
-METHODS	Secondary outcomes include dietary fat , fruit , and vegetable intake ; physical activity ; stress , and affect .
-METHODS	Mediators are self-efficacy , emotional coping response , social support , and autonomous motivation .
-METHODS	Telephone interviews and in-person data collection at WIC offices occur at 3 time points : baseline , immediately , and 3 months after the 16-week intervention .
-CONCLUSIONS	If MIM shows effectiveness , it could have a favorable impact on public health and community programs .
-CONCLUSIONS	The DVDs and PSGTs will be disseminated in WIC , Extension , clinical practice that promote healthy lifestyles for similar target audiences to make a broad contribution to the prevention of weight gain in low-income mothers .
-CONCLUSIONS	Also , our methodology can be adapted by researchers and community stakeholders to help other low-income populations prevent weight gain .
-BACKGROUND	Clinical Trials Number : NCT01839708 .
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-###25602456
-BACKGROUND	Deep sedation of surgical patients may be associated with hypoventilation , airway collapse , and hypercarbia , although the extent of hypercarbia is rarely quantified .
-BACKGROUND	In this prospective , randomized , controlled clinical pilot study , we assessed the efficacy of nasal continuous positive airway pressure ( nCPAP ) for reducing arterial partial pressure of carbon dioxide ( PaCO2 ) among deeply sedated , spontaneously ventilated patients undergoing total knee arthroplasty ( TKA ) under subarachnoid block ( SAB ) , versus standard airway management in a control group .
-METHODS	Forty ASA status I-III patients underwent deep sedation with propofol to level 2 on the Modified Observers Assessment of Alertness/Sedation Scale during TKA performed under SAB .
-METHODS	Nasal or oral airways were placed at the discretion of the anesthesia team , but they were not used in conjunction with nCPAP .
-METHODS	Baseline arterial blood gas analysis ( ABG-1 ) was performed after Modified Observers Assessment of Alertness/Sedation Scale level 2 was reached .
-METHODS	Patients were then randomized to receive nCPAP ( nCPAP group , N = 20 ) or standard oxygen mask management ( control group , N = 20 ) .
-METHODS	A second ABG ( ABG-2 ) was performed 30 minutes later to assess the effect of nCPAP on PaCO2 .
-METHODS	The primary efficacy end point was change in PaCO2 from baseline to the 30-minute time point .
-RESULTS	Baseline ( ABG-1 ) PaCO2 values were similar between nCPAP and control groups with median values of 54.5 and 56.1 mm Hg , respectively .
-RESULTS	There was a significant decline in PaCO2 in the nCPAP group ( median of -4.6 mm Hg [ 10th-90th quantile , -14.55 to 3.85 ] ) as compared with the control group ( median of 0.95 mm Hg [ -4.75 to 9.85 ] ; P = 0.015 ; 95 % confidence interval [ CI ] for location shift = -9.5 to -1.3 ) .
-RESULTS	Within the control group , PaCO2 was similar from ABG-1 to ABG-2 ( median [ 10th-90th quantile ] = 56.1 mm Hg [ 47.2-67 .0 ] vs 56.6 mm Hg [ 46-68 .8 ] ; P = 0.52 ; 95 % CI for the median = -3.4 to 3.4 ) .
-RESULTS	Forty percent of all patients received an airway before ABG-1 .
-RESULTS	The baseline PaCO2 value of patients receiving an airway was not different from that of patients without an airway ( median [ 10th-90th quantile ] = 56.0 mm Hg [ 46.0-68 .4 ] vs 54.1 mm Hg [ 45.6-65 .6 ] , respectively ; P = 0.33 ; 95 % CI for location shift = -2.30 to 7.20 ) .
-CONCLUSIONS	Deep sedation of TKA patients during SAB resulted in moderate hypercarbia ( mean and median PaCO2 = 55 ) .
-CONCLUSIONS	There was a trend showing that nCPAP treatment reduced PaCO2 versus treatment for control group patients receiving standard airway management ; however , estimated treatment difference varied widely , from 1.4 to 12.6 mm Hg .
-CONCLUSIONS	Among control group patients , the initial PaCO2 during deep sedation was similar to the PaCO2 when measured after a 30-minute period of continued deep sedation .
-CONCLUSIONS	Finally , baseline PaCO2 among deeply sedated patients who received an airway was not different from that of patients who did not receive an airway .
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-###25352893
-BACKGROUND	Funnel technique is a method used for the insertion of screw into thoracic pedicle .
-OBJECTIVE	To evaluate the biomechanical characteristics of thoracic pedicle screw placement using the Funnel technique , trying to provide biomechanical basis for clinical application of this technology .
-METHODS	14 functional spinal units ( T6 to T10 ) were selected from thoracic spine specimens of 14 fresh adult cadavers , and randomly divided into two groups , including Funnel technique group ( n = 7 ) and Magerl technique group ( n = 7 ) .
-METHODS	The displacement-stiffness and pull-out strength in all kinds of position were tested and compared .
-RESULTS	Two fixed groups were significantly higher than that of the intact state ( P < 0.05 ) in the spinal central axial direction , compression , anterior flexion , posterior bending , lateral bending , axial torsion , but there were no significant differences between two fixed groups ( P > 0.05 ) .
-RESULTS	The mean pull-out strength in Funnel technique group ( 789.09 27.33 ) was lower than that in Magerl technique group ( P < 0.05 ) .
-CONCLUSIONS	The Funnel technique for the insertion point of posterior bone is a safe and accurate technique for pedicle screw placement .
-CONCLUSIONS	It exhibited no effects on the stiffness of spinal column , but decreased the pull-out strength of pedicle screw .
-CONCLUSIONS	Therefore , the funnel technique in the thoracic spine affords an alternative for the standard screw placement .
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-###25054390
-BACKGROUND	Thoracic epidural analgesia ( TEA ) has a well-known effect on neurohormonal response .
-BACKGROUND	Attenuation of stress response by post-operative epidural analgesia has shown beneficial effects such as lower pain scores and less immunological alterations .
-OBJECTIVE	Investigation of the combined effects of TEA and protective lung ventilation on pro-inflammatory cytokines and patients ' outcome after Ivor Lewis esophagectomy .
-METHODS	A randomized controlled study .
-METHODS	Academic medical center .
-METHODS	Thirty patients of the American Society of Anesthesiologists ( ASA ) I and II were randomly allocated into 2 groups : G1 ( n = 15 ) patients received general anesthesia and were mechanically ventilated with 9 mL/kg during 2 lung ventilations , reduced to 5 mL/kg and 5cm H2O positive end expiratory pressure ( PEEP ) during one lung ventilation ( OLV ) or GII ) ( n = 15 ) patients received TEA and the same general anesthesia and mechanical ventilation used in G1 .
-METHODS	Assessment parameters included hemodynamics , pain severity , total analgesic consumption , and measurement of interleukins ( IL ) ( IL-6 and IL-8 ) at baseline time after anesthetic induction ( TBaseline , ) ; at the end of the abdominal stage of the operation ( TAbdo , ) ; 15 minutes after initiation and at the end of OLV ( TOLV 15 ) and ( TOLV End ) respectively ; one and 20 hours after the end of the surgical procedure ( TPostop1 and TPostop20 ) , respectively , and patient 's outcome also recorded .
-RESULTS	There was a significant reduction in mean arterial blood pressure ( MAP ) and pulse rate in GII during the intraoperative period , at Tabdo , TOLV15 , and TOLV End ( P < 0.05 ) .
-RESULTS	The mean of systolic blood pressure ( SBP ) values were significantly lower in GII over all 3 post-operative days ( P = 0.001 ) , and the mean diastolic blood pressure ( DBP ) showed a significant reduction in GII for 16 hours post-operatively ( P = 0.001 ) .
-RESULTS	The mean of heart rate values showed a significant reduction in GII over all 3 post-operative days in comparison to GI ( P = 0.001 ) .
-RESULTS	The mean resting and dynamic VAS scores were significantly reduced in GII at all time periods studied in comparison to G1 ( P = 0.001 ) .
-RESULTS	The daily PCA morphine consumption was markedly decreased in GII compared to GI in the first 3 days post-operatively ( P = 0.001 ) .
-RESULTS	There were significant reductions in blood level of IL-6 and IL-8 in GII compared to G1 over the entire study period ( P < 0.05 ) .
-RESULTS	There were no significant differences in post-operative adverse effects between the 2 groups ( P > 0.05 ) .
-RESULTS	The duration of stay in PACU was significantly decreased in GII ( 10 2 days ) compared to GI ( 15 3 days ) ( P = 0.001 ) .
-CONCLUSIONS	This study is limited by its sample size .
-CONCLUSIONS	Our study concluded that TEA reduced the systemic pro-inflammatory response and provided optimal post-operative pain relief .
-CONCLUSIONS	Although there were no significant differences in adverse events , there was a trend towards improved outcome .
-CONCLUSIONS	Further clinical studies with larger numbers of patients are required .
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-###24879143
-OBJECTIVE	Laparoscopic cholecystectomy ( LC ) , a gold standard procedure can be done without energized dissection ( ED ) .
-OBJECTIVE	We did a randomized study for the outcomes of LC done with ED or without ED , i.e. , with cold dissection ( CD ) .
-METHODS	At a tertiary level institution , open-ended prospective-randomized control study was conducted between September 2008 and June 2013 .
-METHODS	Consecutive , unselected , consenting candidates for LC were enrolled following standard ethics , informed consent , anesthesia , and clinical pathway protocol .
-METHODS	They were allocated to control group ( LC with ED ) or study group ( LC with CD , as per our published technique with the option for rescue ED ) .
-METHODS	The study points were based upon Clavien-Dindo grading of postoperative complications .
-METHODS	They were either , peri-operative events potentially affecting , hospital stay ( Grade I ) or Grade II-V , e.g. , peri-operative hemodynamic instability , needing intervention/blood transfusion , injury to biliary ducts/hollow viscous , postoperative biliary leak , postoperative re-intervention , re-hospitalization , mortality , and any adverse event during a 90-day follow-up period .
-METHODS	The data were prospectively collected in an integrated `` hospital information system '' that could be retrieved only by independent external coordinators .
-RESULTS	Demographics , co-morbidities , and gallbladder inflammation profile of the control group ( n = 361 ) and study group ( n = 384 ) were comparable .
-RESULTS	There was no rescue ED usage in the study group .
-RESULTS	Hospital stay ( Grade I adverse outcome dependent ) was longer , i.e. , 1.6 1.03 in the control versus 1.35 1.2 days in the study group ( p < 0.001 ) .
-RESULTS	Grade II-IV complications were significantly more ( p < 0.009 ) in control group .
-RESULTS	There was one common bile duct ( CBD ) injury in each group .
-RESULTS	The index bilio-enteric anastomosis for CBD injury in control group failed and needed a revision with multiple interventions .
-RESULTS	There was one grade V adverse outcome , i.e. , mortality in the control group .
-CONCLUSIONS	Avoiding the use of ED in LC is associated with better outcomes .
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-###24880956
-BACKGROUND	Surgical site infections ( SSIs ) are responsible for significant morbidity , mortality , and excess use of health care resources .
-BACKGROUND	The preadmission antiseptic shower is accepted as an effective strategy for reducing the risk for SSIs .
-BACKGROUND	The study analyzes the benefit of an innovative electronic patient alert system ( EAS ) for enhancing compliance with a preadmission showering protocol with 4 % chlorhexidine gluconate ( CHG ) .
-METHODS	After providing informed consent , 80 volunteers were randomized to 4 CHG showering groups .
-METHODS	Groups A1 and A2 showered twice .
-METHODS	Group A1 was prompted to shower via EAS .
-METHODS	Groups B1 and B2 showered 3 times .
-METHODS	Group B1 was prompted via EAS .
-METHODS	Subjects in groups A2 and B2 were not prompted ( non-EAS groups ) .
-METHODS	Skin-surface concentrations of CHG ( g/mL ) were analyzed using colorimetric assay at 5 separate anatomic sites .
-METHODS	Study personnel were blinded to the randomization code ; after final volunteer processing , the code was broken and individual groups were analyzed .
-RESULTS	Mean composite CHG skin-surface concentrations were significantly higher ( p < 0.007 ) in EAS groups A1 ( 30.9 8.8 g/mL ) and B1 ( 29.0 8.3 g/mL ) compared with non-EAS groups A2 ( 10.5 3.9 g/mL ) and B2 ( 9.5 3.1 g/mL ) .
-RESULTS	Overall , 66 % and 67 % reductions in CHG skin-surface concentrations were observed in non-EAS groups A2 and B2 compared with EAS study groups .
-RESULTS	Analysis of returned ( unused ) CHG ( mL ) suggests that a wide variation in volume of biocide was used per shower in all groups .
-CONCLUSIONS	The findings suggest that EAS was effective in enhancing patient compliance with a preadmission showering protocol , resulting in a significant ( p < 0.007 ) increase in skin-surface concentrations of CHG compared with non-EAS controls .
-CONCLUSIONS	However , variation in amount of unused 4 % CHG suggests that rigorous standardization is required to maximize the benefits of this patient-centric interventional strategy .
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-###24864326
-OBJECTIVE	To compare the efficacy and safety outcomes of bimanual microincision cataract surgery ( MICS ) versus 2.2-mm coaxial phacoemulsification assisted by Femtosecond LenSx ( Alcon-LenSx Inc. , Aliso Viejo , CA ) .
-METHODS	This prospective , randomized , observational , comparative case series comprised 50 cataractous eyes of 50 patients receiving femtosecond laser refractive lens surgery followed by a bimanual MICS technique with two 1-mm incisions ( 25 patients ) ( FemtoMICS group ) and a coaxial phacoemulsification technique with a 1-mm paracentesis and a 2.2-mm principal incision ( 25 patients ) ( FemtoCoaxial group ) .
-METHODS	The main outcomes measures were : ultrasound power , effective phacoemulsification time , postoperative spherical equivalent , higher-order aberrations ( corneal and internal ) , corneal thickness , endothelial cell count , macular thickness , and complications during and after surgery .
-METHODS	Both groups were absolutely comparable for all variables preoperatively .
-RESULTS	Mean ultrasound power was 1.8 % 0.9 % for MICS and 14.7 % 4.9 % for 2.2-mm incisions ( P < .001 ) .
-RESULTS	Effective phacoemulsification time values for MICS and 2.2-mm incisions were 1.5 0.9 and 4.5 2.9 sec , respectively ( P = .002 ) .
-RESULTS	Mean postoperative spherical equivalent was 0.26 for FemtoMICS and 0.33 for FemtoCoaxial ( P > .05 ) .
-RESULTS	The efficacy index at 1 month postoperatively was 160.2 % for FemtoMICS and 149 % for FemtoCoaxial .
-RESULTS	No significant differences were found in corneal thickness , endothelial cell count , and macular thickness .
-RESULTS	Complications included posterior capsule rupture ( 4 % ) and anterior capsule rupture with no posterior capsule tear ( 4 % ) for FemtoMICS and bridges due to incomplete capsulorhexis ( 4 % ) for FemtoCoaxial .
-CONCLUSIONS	MICS and coaxial phacoemulsification techniques assisted by the Femtosecond LenSx achieved excellent safety and efficient outcomes .
-CONCLUSIONS	The FemtoMICS technique was surgically and statistically more efficient than the FemtoCoaxial technique .
-
-###25218783
-OBJECTIVE	MicroRNA-122 ( miR-122 ) is an important host factor for hepatitis C virus ( HCV ) and promotes HCV RNA accumulation .
-OBJECTIVE	Decreased intra-hepatic levels of miR-122 were observed in patients with hepatocellular carcinoma , suggesting a potential role of miR-122 in the development of HCC .
-OBJECTIVE	Miravirsen targets miR-122 and resulted in a dose dependent and prolonged decrease of HCV RNA levels in chronic hepatitis C patients .
-OBJECTIVE	The aim of this study was to establish the sustained virological response rate to peginterferon ( P ) and ribavirin ( R ) following miravirsen dosing and to assess long-term safety in patients treated with miravirsen .
-METHODS	In this multicenter , retrospective follow-up study we included 36 treatment nave patients with chronic hepatitis C genotype 1 who received five weekly subcutaneous injections with miravirsen or placebo over a 29-day period in a phase 2a study .
-METHODS	Patients were offered PR therapy 3weeks ( 3mg/kg group ) or 6weeks ( 5 or 7mg/kg group ) after completion of miravirsen or placebo dosing .
-RESULTS	PR therapy was started in 14/36 patients of whom 12 had received miravirsen .
-RESULTS	SVR was achieved in 7/12 patients previously dosed with miravirsen .
-RESULTS	All patients dosed with 7mg/kg miravirsen who were subsequently treated with PR achieved SVR .
-RESULTS	One patient had a prolonged undetectable HCV RNA period from week 14 to week 29 after baseline without subsequent antiviral therapy and relapsed thereafter .
-RESULTS	None of the patients treated with anti-miR-122 developed HCC or other liver-related complications .
-CONCLUSIONS	No long-term safety issues were observed among 27 miravirsen-treated patients .
-CONCLUSIONS	Targeting miR-122 may be an effective and safe treatment strategy for HCV infection and should be investigated in larger clinical trials .
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-###25563311
-BACKGROUND	The efficacy of montelukast ( MONT ) , a cysteinyl leukotriene receptor antagonist , in nonasthmatic eosinophilic bronchitis ( NAEB ) , especially its influence on cough associated life quality is still indefinite .
-BACKGROUND	We evaluated the efficacy of MONT combined with budesonide ( BUD ) as compared to BUD monotherapy in improving life quality , suppressing airway eosinophilia and cough remission in NAEB .
-METHODS	A prospective , open-labeled , multicenter , randomized controlled trial was conducted .
-METHODS	Patients with NAEB ( aged 18-75 years ) were randomized to inhaled BUD ( 200 g , bid ) or BUD plus oral MONT ( 10 g , qn ) for 4 weeks .
-METHODS	Leicester cough questionnaire ( LCQ ) life quality scores , cough visual analog scale ( CVAS ) scores , eosinophil differential ratio ( Eos ) , and eosinophil cationic protein ( ECP ) in induced sputum were monitored and compared .
-RESULTS	The control and MONT groups contained 33 and 32 patients , respectively , with similar baseline characteristics .
-RESULTS	Significant with-in group improvement in CVAS , LCQ scores , Eos , and ECP was observed in both groups during treatment .
-RESULTS	After 2-week treatment , add-on treatment of MONT was significantly more effective than BUD monotherapy for CVAS decrease and LCQ scores improvement ( both P < 0.05 ) .
-RESULTS	Similar results were seen at 4-week assessment ( both P < 0.05 ) .
-RESULTS	4-week add-on therapy of MONT also resulted in a higher percentage of patients with normal sputum Eos ( < 2.5 % ) and greater decrease of ECP ( both P < 0.05 ) .
-CONCLUSIONS	MONT combined with BUD was demonstrated cooperative effects in improvement of life quality , suppression of eosinophilic inflammation , and cough remission in patients with NAEB .
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-###25668645
-BACKGROUND	Adolescents living in South Africa are at high risk for HIV and other sexually transmitted diseases ( STDs ) .
-BACKGROUND	The present study sought to identify correlates of curable STD incidence among a cohort of adolescents in Eastern Cape Province , South Africa .
-METHODS	Data were collected in conjunction with an HIV/STD prevention intervention randomized controlled trial .
-METHODS	At 54 months postintervention , curable STD incidence ( gonorrhea , chlamydial infection , and trichomoniasis ) was assayed and self-report measures of potential correlates of STD incidence were collected .
-RESULTS	Participants were adolescents reporting at least 1 sexual partner in the past 3 months ( n = 659 ) .
-RESULTS	As expected , univariate analyses revealed that girls were more likely than boys to have an STD .
-RESULTS	In addition , intimate partner violence , unprotected sex , and having older partners were associated with incident STD .
-RESULTS	In Poisson multiple regression analyses , sex ( risk ratio [ RR ] , 4.00 ; 95 % confidence interval [ CI ] , 2.51-6 .39 ) , intimate partner violence ( RR , 1.23 ; 95 % CI , 1.12-1 .35 ) , unprotected sex ( RR , 1.42 ; 95 % CI , 1.09-2 .01 ) , and multiple partners ( RR , 1.70 ; 95 % CI , 1.11-2 .61 ) , but not partner 's age ( RR , 1.00 ; 95 % CI , 0.94-1 .07 ) were associated with incident STD , adjusting for 42-month STD prevalence .
-RESULTS	Binge drinking , forced sex , and age were unrelated to STD incidence in both analyses .
-RESULTS	Interactions between sex and the hypothesized correlates were nonsignificant , suggesting that sex did not modify these relationships .
-CONCLUSIONS	Interventions to reduce HIV/STD incidence among adolescents in South Africa should address the risk associated with sex , unprotected sex , intimate partner violence , and multiple partnerships .
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-###25306746
-OBJECTIVE	To identify micronutrient deficiencies in patients with functional bowel diseases ( FBD ) and to reveal their correction with functional foods and probiotics .
-METHODS	The health status was evaluated in 90 patients aged 18 to 67 years with FBD .
-METHODS	All the patients were randomized into 3 groups according to the treatment regimen .
-METHODS	Group 1 took Amaltea goat 's milk 200 ml/day during basic therapy ; Group 2 received multispecies and multistrain RioFlora Balance probiotics in addition to the above components ; Group 3 ( a control group ) had traditional basic dietary therapy .
-METHODS	All the groups continued their treatment for 14 days .
-RESULTS	The performed examinations have demonstrated that diet-based treatment fortified with goat 's milk and multispecies probiotics makes it possible to more promptly achieve remission and to level off clinical manifestations than in the control group .
-RESULTS	The patients using multispecies probiotics versus the control group showed a reduction in fat-soluble vitamin deficiencies and a considerable improvement in quality of life .
-CONCLUSIONS	FBD lacks a specific clinical picture and may be masked as lactase deficiency , which commonly leads to noticeable limitations in patients ' diet and favors the development of vitamin deficiency .
-CONCLUSIONS	Of particular concern is the development of vitamin D deficiency in young patients , which may result in the early development of osteoporosis in the future .
-CONCLUSIONS	To specify the composition of enzymes in the patients gives grounds to refuse restricted diets , and the dietary addition of functional foods ( goat 's milk fortified with vitamins and minerals ) , particularly in combination with multistrain probiotics , produces a pronounced clinical effect and eliminates fat-soluble vitamin deficiencies .
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-###25965717
-OBJECTIVE	We examined the effect of the renin inhibitor , aliskiren , on renal blood flow ( RBF ) in patients with heart failure with reduced ejection fraction ( HFREF ) and decreased glomerular filtration rate ( GFR ) .
-OBJECTIVE	Renal blood flow is the main determinant of GFR in HFREF patients .
-OBJECTIVE	Both reduced GFR and RBF are associated with increased mortality .
-OBJECTIVE	Aliskiren can provide additional renin-angiotensin-aldosterone system inhibition and increases RBF in healthy individuals .
-RESULTS	Patients with left ventricular ejection fraction 45 % and estimated GFR 30 to 75 mL/min per 1.73 m ( 2 ) on optimal medical therapy were randomized 2:1 to receive aliskiren 300 mg once daily or placebo .
-RESULTS	Renal blood flow and GFR were measured using radioactive-labeled ( 125 ) I-iothalamate and ( 131 ) I-hippuran at baseline and 26 weeks .
-RESULTS	After 41 patients were included , the trial was halted based on an interim safety analysis showing futility .
-RESULTS	Mean age was 68 9 years , 82 % male , GFR ( 49 16 mL/min per 1.73 m ( 2 ) ) , RBF ( 294 77 mL/min per 1.73 m ( 2 ) ) , and NT-proBNP 999 ( 435-2040 ) pg/mL .
-RESULTS	There was a nonsignificant change in RBF after 26 weeks in the aliskiren group compared with placebo ( -7.1 30 vs +14 54 mL/min per 1.73 m ( 2 ) ; P = .16 ) .
-RESULTS	However , GFR decreased significantly in the aliskiren group compared with placebo ( -2.8 6.0 vs +4.4 9.6 mL/min per 1.73 m ( 2 ) ; P = .01 ) as did filtration fraction ( -2.2 3.3 vs +1.1 3.1 % ; P = .01 ) .
-RESULTS	There were no significant differences in plasma aldosterone , NT-proBNP , urinary tubular markers , or adverse events .
-RESULTS	Plasma renin activity was markedly reduced in the aliskiren group versus placebo throughout the treatment phase ( P = .007 ) .
-CONCLUSIONS	Adding aliskiren on top of optimal HFREF medical therapy did not improve RBF and was associated with a reduction of GFR and filtration fraction .
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-###25466568
-BACKGROUND	Coronary CT angiography ( CCTA ) has high sensitivity , with 3 recent randomized trials favorably comparing CCTA to standard-of-care .
-BACKGROUND	Comparison to exercise stress ECG ( ExECG ) , the most available and least expensive standard-of-care worldwide , has not been systematically tested .
-METHODS	CT-COMPARE was a randomized , single-center trial of low-intermediate risk chest pain subjects undergoing CCTA or ExECG after the first negative troponin .
-METHODS	From March 2010 to April 2011 , 562 patients randomized to either dual-source CCTA ( n = 322 ) or ExECG ( n = 240 ) .
-METHODS	Primary endpoints were diagnostic performance for ACS , and hospital cost at 30 days .
-METHODS	Secondary endpoints were time-to-discharge , admission rates , and downstream resource utilization .
-RESULTS	ACS occurred in 24 ( 4 % ) patients .
-RESULTS	ExECG had 213 negative studies and 27 ( 26 % ) positive studies for ACS with sensitivity of 83 % [ 95 % CI : 36 , 99.6 % ] , specificity of 91 % [ CI : 86 , 94 % ] , and ROC AUC of 0.87 [ CI : 0.70 , 1 ] .
-RESULTS	CCTA ( > 50 % stenosis considered positive ) had 288 negative studies and 18/35 ( 51 % ) positive studies with a sensitivity of 100 % [ CI : 81.5 , 100 ] , specificity of 94 % [ CI : 91.2 , 96.7 % ] , and ROC of 0.97 [ CI : 0.92 , 1.0 ; p = 0.2 ] .
-RESULTS	Despite CCTA having higher odds of downstream testing ( OR 2.0 ) , 30 day per-patient cost was significantly lower for CCTA ( $ 2193 vs $ 2704 , p < 0.001 ) .
-RESULTS	Length of stay for CCTA was significantly reduced ( 13.5 h [ 95 % CI : 11.2-15 .7 ] , ExECG 19.7 h [ 95 % CI : 17.4-22 .1 ] , p < 0.0005 ) , which drove the reduction in cost .
-RESULTS	No patient had post-discharge cardiovascular events at 30 days .
-CONCLUSIONS	CCTA had improved diagnostic performance compared to ExECG , combined with 35 % relative reduction in length-of-stay , and 20 % reduction in hospital costs .
-CONCLUSIONS	These data lend further evidence that CCTA is useful as a first line assessment in emergency department chest pain .
-
-###25591799
-BACKGROUND	Tivozanib hydrochloride ( tivozanib ) is a potent and selective tyrosine kinase inhibitor of all 3 vascular endothelial growth factor receptors with antitumor activity additive to 5-fluorouracil in preclinical models .
-BACKGROUND	This study was conducted to determine maximum tolerated dose ( MTD ) , dose-limiting toxicities ( DLTs ) , pharmacokinetics ( PKs ) , and antitumor activity of escalating doses of tivozanib with a modified ( m ) FOLFOX-6 ( leucovorin , 5-fluorouracil [ 5-FU ] , and 85 mg/kg ( 2 ) oxaliplatin ) regimen in patients with advanced gastrointestinal tumors .
-METHODS	Tivozanib was administered orally once daily for 21 days in 28-day cycles , with mFOLFOX-6 administered every 14 days .
-METHODS	Patients were allowed to continue tivozanib after discontinuation of mFOLFOX-6 .
-RESULTS	Thirty patients were assigned to tivozanib 0.5 mg ( n = 9 ) , 1.0 mg ( n = 3 ) , or 1.5 mg ( n = 18 ) with mFOLFOX-6 .
-RESULTS	Patients received a median of 5.2 ( range , 0.03-26 .9 ) months of tivozanib .
-RESULTS	DLTs were observed in 2 patients : Grade 3/4 transaminase level increases with tivozanib 0.5 mg , and Grade 3 dizziness with tivozanib 1.5 mg .
-RESULTS	Other Grade 3/4 adverse events included hypertension ( n = 8 ) , fatigue ( n = 8 ) , and neutropenia ( n = 6 ) .
-RESULTS	MTD for tivozanib with mFOLFOX-6 was confirmed as 1.5 mg .
-RESULTS	No PK interactions between tivozanib and mFOLFOX-6 were observed .
-RESULTS	One patient had an ongoing clinical complete response , 10 had a partial response , and 11 obtained prolonged stable disease .
-CONCLUSIONS	Tivozanib and mFOLFOX-6 is feasible and appears to be safe .
-CONCLUSIONS	The recommended dose for tivozanib with mFOLFOX-6 is 1.5 mg/d .
-CONCLUSIONS	Observed clinical activity merits further exploration in gastrointestinal tumors .
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-###24977456
-OBJECTIVE	Although adiposity has been considered to be protective against hot flashes , newer data suggest positive relationships between hot flashes and adiposity .
-OBJECTIVE	No studies have been specifically designed to test whether weight loss reduces hot flashes .
-OBJECTIVE	This pilot study aimed to evaluate the feasibility , acceptability , and initial efficacy of behavioral weight loss in reducing hot flashes .
-METHODS	Forty overweight or obese women with hot flashes ( 4 hot flashes/d ) were randomized to either behavioral weight loss intervention or wait-list control .
-METHODS	Hot flashes were assessed before and after intervention via physiologic monitoring , diary , and questionnaire .
-METHODS	Comparisons of changes in hot flashes and anthropometrics between conditions were performed via Wilcoxon tests .
-RESULTS	Study retention ( 83 % ) and intervention satisfaction ( 93.8 % ) were high .
-RESULTS	Most women ( 74.1 % ) reported that hot flash reduction was a major motivator for losing weight .
-RESULTS	Women randomized to the weight loss intervention lost more weight ( -8.86 kg ) than did women randomized to control ( +0.23 kg ; P < 0.0001 ) .
-RESULTS	Women randomized to weight loss also showed greater reductions in questionnaire-reported hot flashes ( 2-wk hot flashes , -63.0 ) than did women in the control group ( -28.0 ; P = 0.03 ) - a difference not demonstrated in other hot flash measures .
-RESULTS	Reductions in weight and hot flashes were significantly correlated ( eg , r = 0.47 , P = 0.006 ) .
-CONCLUSIONS	This pilot study shows a behavioral weight loss program that is feasible , acceptable , and effective in producing weight loss among overweight or obese women with hot flashes .
-CONCLUSIONS	Findings indicate the importance of a larger study designed to test behavioral weight loss for hot flash reduction .
-CONCLUSIONS	Hot flash management could motivate women to engage in this health-promoting behavior .
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-###25517820
-METHODS	The bioavailability of rifampicin ( RMP ) decreases by 30 % on interaction with isoniazid ( INH ) in stomach acid conditions , which can result in the development of drug resistance and treatment failure .
-OBJECTIVE	To compare the bioavailability in healthy volunteers of five anti-tuberculosis fixed-drug combinations ( FDCs ) used in China ( formulations A-E ) containing RMP and INH against single-drug formulations taken as reference .
-METHODS	Two - or three-period , two - or three-sequence crossover study of drugs .
-RESULTS	Only RMP formulation E passed the bioequivalence criteria , with 90 % confidence intervals for the log-transformed ratios of AUC , AUC , and Cmax of respectively 89.9-103 .7 , 89.6-102 .2 and 87.7-107 .9 .
-RESULTS	For INH , formulations A , B , C and D passed the bioequivalence test , but not product E , where the 90 % CIs of the log-transformed ratios of AUC , AUC , and Cmax were respectively 85.2-100 .7 , 85.2-100 .7 and 73.8-100 .9 .
-CONCLUSIONS	According to the results of the bioequivalence analysis carried out in this study , RMP formulations A , B , C and D were not within the acceptable range and only formulation E passed the bioequivalence criteria of 80-125 % .
-CONCLUSIONS	In comparison , four-test INH formulations ( A , B , C and D ) were bioequivalent to the corresponding single-drug formulation , while product E failed in the bioequivalence criteria .
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-###25115507
-OBJECTIVE	In athletes , caffeine use is common although its effects on sleep have not been widely studied .
-OBJECTIVE	This randomised , double-blind , placebo-controlled crossover trial investigated the effects of late-afternoon caffeine and carbohydrate-electrolyte ( CEB ) co-ingestion on cycling performance and nocturnal sleep .
-METHODS	Six male cyclists/triathletes ( age 27.5 6.9 years ) completed an afternoon training session ( TS ; cycling 80 min ; 65 % VOmax ) followed by a 5 kJ kg ( -1 ) cycling time trial ( TT ) .
-METHODS	Caffeine ( split dose 2 3 mg kg ( -1 ) ) or placebo was administered 1 h prior and 40 min into the TS .
-METHODS	A 7.4 % CEB ( 3 ml kg ( -1 ) every 15 min ) was administered during the TS , followed 30 min after by a standardised evening meal .
-METHODS	Participants retired at their usual bedtime and indices of sleep duration and quality were monitored via polysomnography .
-METHODS	mean SD .
-RESULTS	All participants performed better in the caffeine TT ( caffeine 19.7 3.3 ; placebo 20.5 3.5 min ; p = 0.006 ) , while ratings of perceived exertion ( caffeine 12.0 0.6 ; placebo 12.9 0.7 ; p = 0.004 ) and heart rate ( caffeine 175 6 ; placebo 167 11 bpm ; p = 0.085 ) were lower in the caffeine TS .
-RESULTS	Caffeine intake induced significant disruptions to a number of sleep indices including increased sleep onset latency ( caffeine 51.1 34.7 ; placebo 10.2 4.2 min ; p = 0.028 ) and decreased sleep efficiency ( caffeine 76.1 19.6 ; placebo 91.5 4.2 % ; p = 0.028 ) , rapid eye movement sleep ( caffeine 62.1 19.6 ; placebo 85.8 24.7 min ; p = 0.028 ) and total sleep time ( caffeine 391 97 ; placebo 464 49 min ; p = 0.028 ) .
-CONCLUSIONS	This study supports a performance-enhancing effect of caffeine , although athletes ( especially those using caffeine for late-afternoon/evening training and competition ) should consider its deleterious effects on sleep .
-
-###25206295
-OBJECTIVE	To study the effect of probiotic consumption on the faecal microbiota during and after antibiotic exposure .
-METHODS	A randomized , double-blind , placebo-controlled , parallel group study with a two species probiotic combination [ Lactobacillus acidophilus ( L. acidophilus ) ATCC 700396 and Bifidobacterium lactis ( B. lactis ) ATCC SD5220 ] on healthy adults during and after antibiotic treatment ( amoxicillin 875 and 125 mg clavulanate ) .
-METHODS	The dominant faecal microbiota was studied by real time-polymerase chain reaction to determine if this probiotic preparation could facilitate restoring the microbiota to its pre-antibiotic state and influence the prevalence of beta-lactam resistance .
-METHODS	Gastrointestinal symptoms were recorded by questionnaire and Bristol stool scale .
-RESULTS	Subjects on the probiotic combination had significantly higher faecal counts of L. acidophilus ATCC 700396 and B. lactis at day 8 ( end of antibiotic treatment period ) vs those on placebo .
-RESULTS	Furthermore , subjects on the probiotic combination had significantly higher faecal counts of L. acidophilus ATCC 700396 and B. lactis at Day 15 ( end of probiotic treatment ) vs those on placebo .
-RESULTS	Lactobacillus counts remained stable in the probiotic group over the course of the study , while Clostridium XIV group was higher at the end of the study and closer to baseline levels ; this in contrast to the placebo group .
-RESULTS	Beta-lactam resistance in creased after antibiotic exposure and was not different between both treatment groups .
-RESULTS	Gastrointestinal symptoms were generally mild and did not differ between the treatment groups , which correlates with the generally small changes in the microbiota .
-CONCLUSIONS	Consumption of the probiotic combination mainly leads to an increase in the faecal levels of the species included in the preparation .
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-###25862350
-OBJECTIVE	Capecitabine and S-1 are orally administered fluorinated pyrimidines with high-level activity against metastatic breast cancer ( MBC ) .
-OBJECTIVE	This randomized , multicenter , phase II study compared the activities and safeties of the oral fluoropyrimidines , capecitabine and S-1 , in breast cancer patients .
-METHODS	Patients with MBC were randomly assigned to receive capecitabine 825g/m ( 2 ) twice daily on days 1-21 every 4weeks or S-1 40-60mg twice daily , according to body surface area , on days 1-28 every 6weeks .
-METHODS	The primary endpoint was progression-free survival ( PFS ) .
-RESULTS	A total of 142 patients were enrolled and randomized to either capecitabine ( N = 73 ) or S-1 ( N = 69 ) .
-RESULTS	Median PFS ( progression-free survival ) was 1.2 years for capecitabine and 1.3 years for S-1 , with a hazard ratio ( S-1 / capecitabine ) of 0.85 ( 95 % confidence interval [ CI ] 0.52-1 .38 ) ( P = 0.48 by log-rank ) .
-RESULTS	The confirmed objective response rates were 24.0 % for capecitabine and 23.1 % for S-1 ( P = 0.938 ) .
-RESULTS	The most common treatment-related adverse events were grade 1-2 in intensity .
-RESULTS	Thrombocytopenia ( S-1 : 9.2 % , capecitabine : 1.4 % ; P = 0.040 ) and nausea ( S-1 : 26.2 % , capecitabine : 14.1 % ; P = 0.079 ) were more frequent in the S-1 group , while hand-foot syndrome occurred more often in the capecitabine group ( S-1 : 10.8 % , capecitabine : 25.4 % ; P = 0.029 ) .
-CONCLUSIONS	The results of the current study demonstrate that both S-1 and capecitabine are effective and well-tolerated treatments in patients with MBC , while their adverse events were different .
-CONCLUSIONS	They are both convenient , orally administered drugs , making them attractive agents for use in outpatient treatment .
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-###25057153
-BACKGROUND	Estimates of energy intake ( EI ) in humans have limited validity .
-OBJECTIVE	The objective was to test the accuracy and precision of the intake-balance method to estimate EI during weight gain induced by overfeeding .
-METHODS	In 2 studies of controlled overfeeding ( 1 inpatient study and 1 outpatient study ) , baseline energy requirements were determined by a doubly labeled water study and caloric titration to weight maintenance .
-METHODS	Overfeeding was prescribed as 140 % of baseline energy requirements for 56 d. Changes in weight , fat mass ( FM ) , and fat-free mass ( FFM ) were used to estimate change in energy stores ( ES ) .
-METHODS	Overfeeding EI was estimated as the sum of baseline energy requirements , thermic effect of food , and ES .
-METHODS	The estimated overfeeding EI was then compared with the actual EI consumed in the metabolic chamber during the last week of overfeeding .
-RESULTS	In inpatient individuals , calculated EI during overfeeding determined from ES in FM and FFM was ( mean SD ) 3461 848 kcal/d , which was not significantly ( -29 273 kcal/d or 0.8 % ; limits of agreement : -564 , 505 kcal/d ; P = 0.78 ) different from the actual EI provided ( 3490 729 kcal/d ) .
-RESULTS	Estimated EI determined from ES in weight closely estimated actual intake ( -7 193 kcal/d or 0.2 % ; limits of agreement : -386 , 370 kcal/d ; P = 0.9 ) .
-RESULTS	In free-living individuals , estimated EI during overfeeding determined from ES in FM and FFM was 4123 500 kcal/d and underestimated actual EI ( 4286 488 kcal/d ; -162 301 kcal or 3.8 % ; limits of agreement : -751 , 427 kcal/d ; P = 0.003 ) .
-RESULTS	Estimated EI determined from ES in weight also underestimated actual intake ( -159 270 kcal/d or 3.7 % ; limits of agreement : -688 , 370 kcal/d ; P = 0.001 ) .
-CONCLUSIONS	The intake-balance method can be used to estimate EI during a period of weight gain as a result of 40 % overfeeding in individuals who are inpatients or free-living with only a slight underestimate of actual EI by 0.2-3 .8 % .
-
-###24895878
-OBJECTIVE	To use baseline computed tomographic ( CT ) angiography to analyze imaging and clinical end points in an Interventional Management of Stroke III cohort to identify patients who would benefit from endovascular stroke therapy .
-METHODS	The primary clinical end point was 90-day dichotomized modified Rankin Scale ( mRS ) score .
-METHODS	Secondary end points were 90-day mRS score distribution and 24-hour recanalization .
-METHODS	Prespecified subgroup was baseline proximal occlusions ( internal carotid , M1 , or basilar arteries ) .
-METHODS	Exploratory analyses were subsets with any occlusion and specific sites of occlusion ( two-sided = .01 ) .
-RESULTS	Of 656 subjects , 306 ( 47 % ) underwent baseline CT angiography or magnetic resonance angiography .
-RESULTS	Of 306 , 282 ( 92 % ) had arterial occlusions .
-RESULTS	At baseline CT angiography , proximal occlusions ( n = 220 ) demonstrated no difference in primary outcome ( 41.3 % [ 62 of 150 ] endovascular vs 38 % [ 27 of 70 ] intravenous [ IV ] tissue-plasminogen activator [ tPA ] ; relative risk , 1.07 [ 99 % confidence interval : 0.67 , 1.70 ] ; P = .70 ) ; however , 24-hour recanalization rate was higher for endovascular treatment ( n = 167 ; 84.3 % [ 97 of 115 ] endovascular vs 56 % [ 29 of 52 ] IV tPA ; P < .001 ) .
-RESULTS	Exploratory subgroup analysis for any occlusion at baseline CT angiography did not demonstrate significant differences between endovascular and IV tPA arms for primary outcome ( 44.7 % [ 85 of 190 ] vs 38 % [ 35 of 92 ] , P = .29 ) , although ordinal shift analysis of full mRS distribution demonstrated a trend toward more favorable outcome ( P = .011 ) .
-RESULTS	Carotid T - or L-type occlusion ( terminal internal carotid artery [ ICA ] with M1 middle cerebral artery and/or A1 anterior cerebral artery involvement ) or tandem ( extracranial or intracranial ) ICA and M1 occlusion subgroup also showed a trend favoring endovascular treatment over IV tPA alone for primary outcome ( 26 % [ 12 of 46 ] vs 4 % [ one of 23 ] , P = .047 ) .
-CONCLUSIONS	Significant differences were identified between treatment arms for 24-hour recanalization in proximal occlusions ; carotid T - or L-type and tandem ICA and M1 occlusions showed greater recanalization and a trend toward better outcome with endovascular treatment .
-CONCLUSIONS	Vascular imaging should be mandated in future endovascular trials to identify such occlusions .
-CONCLUSIONS	Online supplemental material is available for this article .
-
-###24461523
-OBJECTIVE	To investigate the potential antioxidant effects of Phyllanthus niruri ( P. niruri , Euphorbiaceae ) tea on healthy subjects .
-METHODS	Five non-smoking , male healthy volunteers , 20 to 31 years old , were enrolled .
-METHODS	Each subject was treated twice , following a randomized crossover fashion regarding the ingestion of P. niruri infusion ( 5 g/750 mL ) ( tea group ) or 750 mL of water ( control group ) .
-METHODS	Fasting venous blood samples were collected prior to and at 1 , 2 and 4 h after infusion drinking .
-METHODS	Samples were tested for plasmatic gallic acid and ascorbic acid levels , erythrocytic catalase and superoxide dismutase activities , and intracellular DCFH fluorescence in granulocytes , monocytes and lymphocytes .
-RESULTS	Catalase and superoxide dismutase activities were not altered by tea ingestion .
-RESULTS	Plasma levels of gallic acid were significantly increased at 1 , 2 and 4 h after P. niruri ingestion and plasma ascorbic acid at 1 h after P. niruri ingestion .
-CONCLUSIONS	Ingestion of P. niruri tea is associated with a slight increase in antioxidant markers in human blood ( ascorbic acid and gallic acid ) , which may contribute to its pharmacological effects .
-
-###24337078
-BACKGROUND	Black box warnings for young adults under the age of 25 years indicate that antidepressants may increase risk of suicide .
-BACKGROUND	While underlying mechanisms for age-related treatment effects remain unclear , vagally mediated cardiovascular function may play a key role .
-BACKGROUND	Decreased heart rate ( HR ) and an increase in its variability ( HRV ) improve one 's capacity to adapt to environmental stress and attenuate risk for suicide .
-OBJECTIVE	Using a double blind , randomized , placebo-controlled , crossover , experimental study , we examine whether a single dose of escitalopram ( 20 mg ) attenuates cardiovascular responses to stress under experimental conditions and determine whether age moderates these effects .
-METHODS	Forty-four healthy females received a single dose of escitalopram ( 20 mg ) and placebo treatment separated by a 1-week interval ( > 5 half-lives ) .
-METHODS	HR and high frequency HRV ( HF HRV normalized units ; 0.15-0 .40 Hz ) were measured during resting state and stress .
-RESULTS	While escitalopram attenuated the increase in HR and increased HF HRV , these moderate to large effects were only significant in participants over 25 years of age .
-RESULTS	No beneficial cardiovascular effects of escitalopram were observed in those under the age of 25 .
-CONCLUSIONS	Maturational differences in the development of the prefrontal cortex -- a critical region in the central network of autonomic control -- may underpin these differential findings .
-CONCLUSIONS	This study provides a theoretical framework on which future research on treatment-emergent suicidality in clinical populations could be based .
-
-###24671361
-OBJECTIVE	Clinical decision support has the potential to improve prevention of venous thromboembolism ( VTE ) .
-OBJECTIVE	The purpose of this prospective study was to analyze the effect of electronic reminders on thromboprophylaxis rates in wards to which patients were admitted and transferred .
-OBJECTIVE	The latter was of particular interest since patient handoffs are considered to be critical safety issues .
-METHODS	The trial involved two study periods in the six departments of a university hospital , three of which were randomly assigned to the intervention group displaying reminders during the second period .
-METHODS	At 6h after admission or transfer , the algorithm checked for prophylaxis orders within 0-30h of the patient 's arrival , increasing the specificity of the displayed reminders .
-RESULTS	The significant impact of the reminders could be seen by prophylaxis orders placed 6-24h after admission ( increasing from 8.6 % ( 223/2579 ) to 12 % ( 307/2555 ) ; p < 0.0001 ) and transfer ( increasing from 2.4 % ( 39/1616 ) to 3.7 % ( 63/1682 ) ; p = 0.034 ) .
-RESULTS	In admission wards , the rate of thromboprophylaxis increased from 62.4 % to 67.7 % ( p < 0.0001 ) , and in transfer wards it increased from 80.2 % to 84.3 % ( p = 0.0022 ) .
-RESULTS	Overall , the rate of prophylaxis significantly increased in the intervention group from 69.2 % to 74.3 % ( p < 0.0001 ) .
-RESULTS	No significant changes were observed in the control group .
-RESULTS	Postponing prophylaxis checks to 6h after admissions and transfers reduced the number of reminders by 62 % and thereby minimized the risk of alert fatigue .
-CONCLUSIONS	The reminders improved awareness of VTE prevention in both admission and transfer wards .
-CONCLUSIONS	This approach may contribute to better quality of care and safer patient handoffs .
-
-###25280408
-OBJECTIVE	The aim of this study was to evaluate the effect of carbohydrate or glutamine supplementation , or a combination of the two , on the immune system and inflammatory parameters after exercise in simulated hypoxic conditions at 4500 m.
-METHODS	Nine men underwent three sessions of exercise at 70 % VO2peak until exhaustion as follows : 1 ) hypoxia with a placebo ; 2 ) hypoxia with 8 % maltodextrin ( 200 mL/20 min ) during exercise and for 2 h after ; and 3 ) hypoxia after 6 d of glutamine supplementation ( 20 g/d ) and supplementation with 8 % maltodextrin ( 200 mL/20 min ) during exercise and for 2 h after .
-METHODS	All procedures were randomized and double blind .
-METHODS	Blood was collected at rest , immediately before exercise , after the completion of exercise , and 2 h after recovery .
-METHODS	Glutamine , cortisol , cytokines , glucose , heat shock protein-70 , and erythropoietin were measured in serum , and the cytokine production from lymphocytes was measured .
-RESULTS	Erythropoietin and interleukin ( IL ) -6 increased after exercise in the hypoxia group compared with baseline .
-RESULTS	IL-6 was higher in the hypoxia group than pre-exercise after exercise and after 2 h recovery .
-RESULTS	Cortisol did not change , whereas glucose was elevated post-exercise in the three groups compared with baseline and pre-exercise .
-RESULTS	Glutamine increased in the hypoxia + carbohydrate + glutamine group after exercise compared with baseline .
-RESULTS	Heat shock protein-70 increased post-exercise compared with baseline and pre-exercise and after recovery compared with pre-exercise , in the hypoxia + carbohydrate group .
-RESULTS	No difference was observed in IL-2 and IL-6 production from lymphocytes .
-RESULTS	IL-4 was reduced in the supplemented groups .
-CONCLUSIONS	Carbohydrate or glutamine supplementation shifts the T helper ( Th ) 1/Th2 balance toward Th1 responses after exercise at a simulated altitude of 4500 m.
-CONCLUSIONS	The nutritional strategies increased in IL-6 , suggesting an important anti-inflammatory effect .
-
-###25532604
-BACKGROUND	In 2006 , Ethicon Inc. introduced a new minimally invasive single incision sling device for the surgical treatment of stress urinary incontinence , the Gynecare TVT Secur .
-BACKGROUND	For device licensing , no new evidence of TVT Secur efficacy and safety was needed : rather evidence was provided of the long-term follow-up of patients who had a procedure using a predecate retropubic tension-free vaginal tape device .
-BACKGROUND	Before adopting TVT Secur into our routine clinical practice , we decided to evaluate it .
-BACKGROUND	The objective of our Canadian multi-centre pragmatic randomized controlled trial was to compare the effectiveness of the new single-incision device , TVT Secur , to the established TVT device , in terms of objective cure of stress urinary incontinence ( SUI ) at 12 months postoperatively .
-BACKGROUND	Other outcomes included : complications , symptoms , and incontinence-related quality of life .
-RESULTS	The sample size estimate for our trial was 300 , but the trial stopped early because of poor recruitment .
-RESULTS	74 women participated ( 40 allocated to TVT Secur , 34 to TVT ) .
-RESULTS	At 12 months postoperatively , 27/33 ( 82 % ) of TVT Secur group were cured , compared with 25/28 ( 89 % ) of the TVT group ( relative risk 0.92 , 95 % confidence interval 0.75 to 1.13 , p = 0.49 ) .
-RESULTS	Most women reported little or no SUI symptoms ( 35/37 ( 95 % ) vs 29/30 ( 97 % ) , > 0.999 ) .
-RESULTS	Quality of life improved significantly from baseline for both groups ( IIQ-7 mean change -25 for both groups ) but did not differ between groups ( p = 0.880 ) .
-CONCLUSIONS	Our small randomized trial did not find statistically significant differences in outcomes between women allocated to the TVT Secur device versus those allocated to the TVT device for stress urinary incontinence .
-CONCLUSIONS	Despite the discontinuation of TVT Secur in March 2013 for commercial reasons , the importance of our study lies in making evidence available for the many women who had a TVT Secur device implanted and their physicians who may be considering alternative treatments .
-CONCLUSIONS	Our experience illustrates the difficulty of undertaking research on new licensed devices in a rapidly changing surgical specialty , and further highlights the need for research before licensing if surgeons and their patients are to be confident in the effectiveness and safety of new surgical devices .
-BACKGROUND	ClinicalTrials.gov NCT00685217 , 22 May 2008 .
-
-###24438460
-BACKGROUND	Prevention of alcohol , drug and tobacco misuse by young people is a key public health priority .
-BACKGROUND	There is a need to develop the evidence base through rigorous evaluations of innovative approaches to substance misuse prevention .
-BACKGROUND	The Strengthening Families Programme 10-14 is a universal family-based alcohol , drugs and tobacco prevention programme , which has achieved promising results in US trials , and which now requires cross-cultural assessment .
-BACKGROUND	This paper therefore describes the protocol for a randomised controlled trial of the UK version of the Strengthening Families Programme 10-14 ( SFP 10-14 UK ) .
-METHODS	The trial comprises a pragmatic cluster randomised controlled effectiveness trial with families as the unit of randomisation , with embedded process and economic evaluations .
-METHODS	Participating families will be randomised to one of two treatment groups - usual care with full access to existing services ( control group ) , or usual care plus SFP 10-14 UK ( intervention group ) .
-METHODS	The trial has two primary outcomes - the number of occasions that young people report having drunk alcohol in the last 30 days , and drunkenness during the last 30 days , both dichotomised as ` never ' and ' 1-2 times or more ' .
-METHODS	The main follow-up is at 2 years past baseline , and short-term and intermediate outcomes are also measured at 9 and 15 months .
-CONCLUSIONS	The results from this trial will provide evidence on the effectiveness and cost-effectiveness of an innovative universal family-based substance misuse prevention programme in a UK context .
-BACKGROUND	Current Controlled Trials ISRCTN63550893 .
-
-###24374539
-OBJECTIVE	To investigate the effect that complications have on patients ' long-term quality of life ( QoL ) after curative colorectal cancer surgery .
-BACKGROUND	Colorectal cancer surgery is a high risk , with approximately 1 in 3 patients suffering a complication .
-BACKGROUND	The long-term consequences of postoperative complications are important but have poorly been documented .
-METHODS	The MRC-CLASICC trial ( laparoscopic-assisted vs open surgery for colorectal cancer ) included prospective evaluation of QoL using validated scoring questionnaires : EORTC QLQ-C30 / CR38 and EQ5D .
-METHODS	These were used to compare QoL at 3 , 6 , 18 , and 36 months to baseline values for patients categorized into 2 groups : ( i ) those suffering any complication and ( ii ) those suffering any of 5 common complications ( wound , chest , anastomotic leak , hemorrhage , and cardiac event ) .
-RESULTS	A total of 614 of 794 CLASICC patients were suitable for inclusion .
-RESULTS	Complications occurred in 215 ( 35.0 % ) patients , including : wound complications ( 61 , 9.9 % ) , chest infection ( 50 , 8.1 % ) , anastomotic leak ( 27 , 4.4 % ) , hemorrhage ( 14 , 2.3 % ) , and cardiac event ( 26 , 4.2 % ) .
-RESULTS	Significant long-term differences in QoL between patients with and without complications were found for Physical and Social Function , Role Functioning , and Body Image on EORTC QLQ-C30 / QLQ-CR38 analysis and Mobility , Self-care , and Pain/Discomfort on EQ5D analysis .
-RESULTS	No significant differences were seen for emotional/cognitive functioning , global QoL , financial difficulties , or future perspectives .
-RESULTS	Risk factors of age , gender , ASA ( American Society of Anesthesiologists ) grade , and stoma moderated the impact of complications in the short - to medium-term QoL , but had less influence on long-term QoL .
-CONCLUSIONS	Postoperative complications have adverse effects on long-term QoL , particularly for Physical , Role and Social Functioning , and Body Image , as well as for Mobility , Self-care , and Pain/Discomfort .
-CONCLUSIONS	These findings should inform future preoperative counseling and health care planning .
-
-###25464260
-OBJECTIVE	Recent data indicate that hypertension is not well controlled in many populations throughout the world .
-OBJECTIVE	The factors that influence individual response to anti-hypertensive treatment need to be clarified .
-OBJECTIVE	Pulse wave velocity ( PWV ) , as a marker of arterial stiffness , has been demonstrated to have important relationships with BP progression ; however , little information is available on the role of PWV in blood pressure ( BP ) control .
-OBJECTIVE	We aimed to assess BP control during the run-in treatment period in the China Stroke Primary Prevention Trial ( CSPPT ) .
-RESULTS	These analyses included a total of 3056 treated hypertensive subjects ( age : 59.67.5 years , male/female 1339/1717 ) with PWV measured at baseline .
-RESULTS	The average BP at enrollment was 166/95mmHg , and declined to 141/85mmHg after short-term antihypertensive treatment ( a median follow-up of 20days ) .
-RESULTS	There was an inverse relationship between PWV level and BP reduction during the treatment , most notably for systolic BP ( with estimated coefficients of -9.01 ( P < 0.001 ) for the top quartile , as compared to the bottom quartile ) .
-RESULTS	The association did not differ significantly by gender or types of antihypertensive drugs .
-RESULTS	Factors related to smaller BP decline were low baseline BP , high baseline PWV , high body mass index , high creatinine , use of fewer types of antihypertensive drug , high heart rate ( only for SBP ) , high homocysteine and low age ( only for DBP ) .
-CONCLUSIONS	PWV appears to be an independent determinant of individual response to anti-hypertensive treatment .
-
-###24580023
-OBJECTIVE	To determine long-term safety and efficacy of adjunctive clobazam for patients with Lennox-Gastaut syndrome ( LGS ) .
-METHODS	Eligible patients from two randomized controlled trials ( Phase II OV-1002 and Phase III OV-1012 ) were able to enroll in open-label extension ( OLE ) study OV-1004 beginning in December 2005 and received clobazam until they discontinued ( mandatory at 2years for patients outside the United States ) or until study completion in March 2012 .
-METHODS	Patients in the United States could have received clobazam for 6years before it became commercially available .
-METHODS	Efficacy assessments included changes in rates of drop seizures and total seizures , responder rates ( 50 % , 75 % , or 100 % decreases in seizure frequency vs. baseline ) , sustained efficacy over time , concomitant antiepileptic drug ( AED ) use , and global evaluations .
-METHODS	Safety assessments included exposure to clobazam , laboratory assessments , physical and neurologic examinations , vital sign monitoring , electrocardiography monitoring , and adverse event reporting .
-RESULTS	Of 267 patients who enrolled in the OLE , 188 ( 70 % ) completed the trial .
-RESULTS	Two hundred seven patients were from the United States , which was the only country in which patients could be treated with clobazam for > 2years .
-RESULTS	Forty-four patients were treated with clobazam for 5years , and 11 for 6years .
-RESULTS	Because of the low number of Year 6 patients , this group is not reported separately .
-RESULTS	Improvements in baseline seizure rates were very stable over the course of the study , with a median 85 % decrease in drop seizures at Year 1 , 87 % at Year 2 , 92 % at Year 3 , 97 % at Year 4 , and a 91 % decrease for patients who had reached Year 5 .
-RESULTS	Similar results were observed for total seizures ( 79 % decrease at both Years 1 and 2 , 82 % decrease at Year 3 , 75 % decrease at Year 4 , and 85 % decrease at Year 5 ) .
-RESULTS	Responder rates were also stable for the duration of the trial .
-RESULTS	Of patients who had achieved a 50 % decrease in median drop-seizure frequency from baseline to Month 3 , 86 % still had that degree of drop-seizure reduction at Year 3 ( and 14 % lost their initial responses ) , and 47 % were drop-seizure-free .
-RESULTS	Most patients who had achieved drop-seizure freedom in the original controlled trials remained drop-seizure-free in the OLE .
-RESULTS	Based on parents ' and physicians ' ratings of global evaluations , 80 % of patients were `` very much improved '' or `` much improved '' after 3years .
-RESULTS	Of the 43 patients with concomitant AED data who were treated for 5years , 30 % increased , 19 % decreased , and 51 % had no change in numbers of AEDs versus their Week 4 regimens .
-RESULTS	The mean modal clobazam dosage was 0.90 mg/kg/day at Year 1 and 0.97 mg/kg/day at Year 5 , suggesting that study patients did not need significant increases in dosage over time .
-RESULTS	The safety profile was what would be expected for clobazam for LGS patients over a 5-year span , and no new safety concerns developed over time .
-CONCLUSIONS	In this largest and longest-running trial in LGS , adjunctive clobazam sustained seizure freedom and substantial seizure improvements at stable dosages through 3years of therapy in this difficult - to-treat patient population .
-CONCLUSIONS	A PowerPoint slide summarizing this article is available for download in the Supporting Information section here .
-
-###24261547
-BACKGROUND	Limited capacity for social engagement is a core feature of autism spectrum disorder ( ASD ) , often evident early in the child 's development .
-BACKGROUND	While these skills are difficult to train , there is some evidence that active involvement in music-making provides unique opportunities for social interaction between participants .
-BACKGROUND	Family-centred music therapy ( FCMT ) endeavours to support social engagement between child and parent within active music-making , yet the extent of benefits provided is unknown .
-OBJECTIVE	This study investigated the impacts of FCMT on social engagement abilities .
-METHODS	Twenty-three children ( 36-60 months ) with severe ASD received either 16 weeks of FCMT in addition to their early intervention programmes ( n = 12 ) , or their early intervention programme only ( n = 11 ) .
-METHODS	Change in social engagement was measured with standardized parent-report assessments , parent interviews and clinician observation .
-RESULTS	Intention-to-treat analysis for the Vineland Social Emotional Early Childhood Scale indicated a significant effect in favour of FCMT .
-RESULTS	Thematic qualitative analysis of the parent interviews showed that the parent-child relationship grew stronger .
-CONCLUSIONS	FCMT improves social interactions in the home and community and the parent-child relationship , but not language skills or general social responsiveness .
-CONCLUSIONS	This study provides preliminary support for the use of FCMT to promote social engagement in children with severe ASD .
-
-###24794703
-BACKGROUND	Insulin analogues have been developed to reduce the risk of hypoglycaemia in patients with diabetes who require insulin-based treatment , but their effect on this endpoint in patients with type 1 diabetes complicated by recurrent severe hypoglycaemia is unknown .
-BACKGROUND	We compared the occurrence of severe hypoglycaemic episodes in such patients during treatment with insulin analogues or human insulin .
-METHODS	In this investigator-initiated , prospective , randomised , open-label , blinded-endpoint crossover trial at seven medical centres in Denmark , we recruited patients ( aged 18 years ) with type 1 diabetes ( diagnosed for > 5 years ) who had reported two or more episodes of severe hypoglycaemia in the preceding year .
-METHODS	Patients were randomly assigned ( 1:1 ) using computer-generated site-specific randomisation lists in blocks of four to treatment with basal-bolus therapy with either analogue insulin ( detemir and aspart ) or human insulin ( human neutral protamine Hagedorn and human regular ) in a balanced crossover design .
-METHODS	A 1-year plus 1-year treatment period was specified , consisting of two 3-month run-in periods , each followed by a 9-month maintenance period .
-METHODS	The primary endpoint was the number of validated episodes of severe hypoglycaemia ( defined by need for treatment assistance from others ) reported during the maintenance periods , analysed by intention to treat .
-METHODS	The study is registered with ClinicalTrials.gov , number NCT00346996 .
-RESULTS	Between May 9 , 2007 , and Oct 30 , 2009 , 159 patients were randomly assigned .
-RESULTS	18 patients discontinued during the first run-in period , leaving 141 patients in the intention-to-treat population .
-RESULTS	136 severe hypoglycaemic episodes were reported during treatment with human insulin and 105 episodes were reported during treatment with insulin analogues , resulting in an absolute rate reduction of 0.51 episodes ( 95 % CI 0.19-0 .84 ) per patient-year with insulin analogues .
-RESULTS	This result corresponds to a relative rate reduction of 29 % ( 95 % CI 11-48 ; p = 0.010 ) .
-CONCLUSIONS	Treatment with insulin detemir and aspart in patients with type 1 diabetes and recurrent severe hypoglycaemia resulted in a clinically significant reduced rate of severe hypoglycaemia compared with human insulin .
-CONCLUSIONS	Patients with the greatest chance of benefitting from improved insulin therapy should be offered treatment with insulin analogues and be included in future trials of new insulins .
-BACKGROUND	Novo Nordisk A/S .
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-###24814320
-OBJECTIVE	To evaluate the effects of humor therapy assessed using observational methods on agitation , engagement , positive behaviors , affect , and contentment .
-METHODS	Single-blind cluster randomized controlled trial .
-METHODS	A total of 35 Sydney nursing homes .
-METHODS	All eligible residents within geographically defined areas within each nursing home were invited to participate .
-METHODS	Professional `` ElderClowns '' provided 9 to 12 weekly humor therapy sessions , augmented by resident engagement by trained staff `` LaughterBosses . ''
-METHODS	Controls received usual care .
-METHODS	The Behavior Engagement Affect Measure ( BEAM ) touchpad observational tool was used to capture real-time behavioral data .
-METHODS	The tool assesses the duration in seconds of agitation , positive behavior toward others , engagement , and affect ( angry , anxious , happy , neutral , sad ) .
-RESULTS	Seventeen nursing homes ( 189 residents ) received the intervention and 18 homes ( 209 residents ) received usual care .
-RESULTS	Over 26 weeks , in comparison with controls , the humor therapy group decreased in duration of high agitation ( effect size = 0.168 and 0.129 at 13 and 26 weeks , respectively ) and increased in duration of happiness ( effect size = 0.4 and 0.236 at 13 and 26 weeks , respectively ) .
-CONCLUSIONS	We confirmed that humor therapy decreases agitation and also showed that it increases happiness .
-CONCLUSIONS	Researchers may consider evaluating impacts of nonpharmaceutical interventions on positive outcomes .
-CONCLUSIONS	Computer-assisted observational measures should be considered , particularly for residents with dementia and when the reliability of staff is uncertain .
-
-###25159818
-OBJECTIVE	To investigate whether a histone deacetylase inhibitor ( HDACi ) would be effective in an in vitro model for the neurodegenerative disease Friedreich ataxia ( FRDA ) and to evaluate safety and surrogate markers of efficacy in a phase I clinical trial in patients .
-METHODS	We used a human FRDA neuronal cell model , derived from patient induced pluripotent stem cells , to determine the efficacy of a 2-aminobenzamide HDACi ( 109 ) as a modulator of FXN gene expression and chromatin histone modifications .
-METHODS	FRDA patients were dosed in 4 cohorts , ranging from 30mg/day to 240mg/day of the formulated drug product of HDACi 109 , RG2833 .
-METHODS	Patients were monitored for adverse effects as well as for increases in FXN mRNA , frataxin protein , and chromatin modification in blood cells .
-RESULTS	In the neuronal cell model , HDACi 109/RG2833 increases FXN mRNA levels and frataxin protein , with concomitant changes in the epigenetic state of the gene .
-RESULTS	Chromatin signatures indicate that histone H3 lysine 9 is a key residue for gene silencing through methylation and reactivation through acetylation , mediated by the HDACi .
-RESULTS	Drug treatment in FRDA patients demonstrated increased FXN mRNA and H3 lysine 9 acetylation in peripheral blood mononuclear cells .
-RESULTS	No safety issues were encountered .
-CONCLUSIONS	Drug exposure inducing epigenetic changes in neurons in vitro is comparable to the exposure required in patients to see epigenetic changes in circulating lymphoid cells and increases in gene expression .
-CONCLUSIONS	These findings provide a proof of concept for the development of an epigenetic therapy for this fatal neurological disease .
-
-###26054177
-OBJECTIVE	To evaluate the effectiveness and tolerability of an experimental 9.5 % hydrogen peroxide whitening strip relative to a placebo control over a three-week period .
-METHODS	In this parallel-design , double-blind clinical trial , 54 adult volunteers were randomized to an experimental 9.5 % hydrogen peroxide whitening strip or placebo strip balancing for age and baseline tooth color , and received treatment .
-METHODS	Strips were worn on the maxillary arch 30 minutes daily for 20 days .
-METHODS	Efficacy was measured objectively as L * a * b * color change from digital images at Days 4 , 7 , 15 , and 21 .
-RESULTS	As early as Day 4 and at all subsequent visits , the 9.5 % strip group experienced significant ( p < 0.004 ) color improvement relative to placebo for b * and L * color parameters .
-RESULTS	The amount of color improvement increased with continuing peroxide strip use .
-RESULTS	Mean SE between-group differences in Ab * were -0.6 0.16 , -0.8 0.15 , -1.6 0.19 , and -1.9 0.20 at Days 4 , 7 , 15 , and 21 , respectively .
-RESULTS	Similar results were noted for AL * .
-RESULTS	Minor tooth sensitivity was the most common adverse event , as reported by 12 % of subjects in the 9.5 % strip group and 11 % of subjects in the placebo group .
-RESULTS	No subjects discontinued treatment due to an adverse event .
-CONCLUSIONS	This placebo-controlled clinical trial demonstrated that an experimental 9.5 % hydrogen peroxide strip yielded significant tooth whitening relative to a placebo strip as early as after three days of product use .
-
-###24750973
-BACKGROUND	Although previous studies have found reminder/recall to be effective in increasing immunization rates , little guidance exists regarding the specific ages at which it is optimal to send reminder/recall notices .
-OBJECTIVE	To assess the relative effectiveness of centralized reminder/recall strategies targeting age-specific vaccination milestones among children in urban areas during June 2008-June 2009 .
-METHODS	Three reminder/recall strategies used capabilities of the Michigan Care Improvement Registry ( MCIR ) , a statewide immunization information system : a 7-month recall strategy , a 12-month reminder strategy , and a 19-month recall strategy .
-METHODS	Eligible children were randomized to notification ( intervention ) or no notification groups ( control ) .
-METHODS	Primary study outcomes included MCIR-recorded immunization activity ( administration of 1 new dose , entry of 1 historic dose , entry of immunization waiver ) within 60 days following each notification cycle .
-RESULTS	A total of 10,175 children were included : 2,072 for the 7-month recall , 3,502 for the 12-month reminder , and 4,601 for the 19-month recall .
-RESULTS	Immunization activity was similar between notification versus no notification groups at both 7 and 12 months .
-RESULTS	Significantly more 19-month-old children in the recall group ( 26 % ) had immunization activity compared to their counterparts who did not receive a recall notification ( 19 % ) .
-CONCLUSIONS	Although recall notifications can positively affect immunization activity , the effect may vary by targeted age group .
-CONCLUSIONS	Many 7 - and 12-month-olds had immunization activity following reminder/recall ; however , levels of activity were similar irrespective of notification , suggesting that these groups were likely to receive medical care or immunization services without prompting .
-
-###25038861
-OBJECTIVE	To investigate whether DTI allows assessment of renal impairment and pathology in patients with chronic glomerulonephritis .
-METHODS	Seventy-five patients and 20 healthy volunteers were enrolled in this study .
-METHODS	Renal function and kidney biopsies were evaluated .
-METHODS	For DTI , a respiratory-triggered coronal EPI sequence was performed ( TR , 1400 ms ; TE , 76 ms ; diffusion direction , 6 ; NEX , 4 ; b values , 0 and 600 s/mm2 ; slices thickness , 6 mm , with no intersection gap ) .
-METHODS	Renal ADC and FA values were calculated and compared between the groups .
-METHODS	Correlations between ADC/FA and histopathology were evaluated .
-RESULTS	ADC values decreased with increased stages .
-RESULTS	ADC differences in renal parenchyma at different disease stages were found , with the exception of the control group compared with stage 1 patients ; similar results were obtained for FA .
-RESULTS	ADC values in the cortex and medulla in stage 1-3 patients were both statistically different , similar to the FA values .
-RESULTS	A significant negative correlation was found between the percentage of glomerulosclerosis and FA in the renal cortex ( r = -0.74 ) , similar to the degree of tubulointerstitial fibrosis with FA in the medulla ( r = -0.76 ) .
-CONCLUSIONS	ADC and FA values are correlated with the degree of renal impairment , the percentage of glomerulosclerosis , and area of interstitial fibrosis .
-CONCLUSIONS	DTI can be used to assess renal function impairment in patients with chronic glomerulonephritis .
-CONCLUSIONS	ADC and FA values were correlated with tubulointerstitial fibrosis and glomerulosclerosis .
-CONCLUSIONS	Identification of renal impairment is helpful for timely treatment .
-CONCLUSIONS	DTI can be used for non-invasive assessment of renal pathology .
-
-###25327949
-BACKGROUND	Posttraumatic stress disorder ( PTSD ) is associated with abnormal functioning of the hypothalamic-pituitary-adrenal ( HPA ) axis ; however , limited research has examined whether cortisol levels change following successful PTSD treatment .
-BACKGROUND	The current study examined the impact of successful PTSD treatment on the cortisol awakening response ( CAR ) .
-METHODS	Twenty-nine adults participating in a treatment trial for chronic PTSD provided saliva samples ( upon waking , and 30 - , 45 - , and 60 min postwaking ) before and after receiving either prolonged exposure therapy or sertraline .
-METHODS	PTSD responder status ( i.e. , loss or retention of a PTSD diagnosis ) served as the predictor variable .
-METHODS	Outcome measures included area under the curve with respect to ground and increase , reflecting total cortisol output and HPA axis reactivity , respectively .
-RESULTS	A series of hierarchical regressions revealed no significant main effects of PTSD responder status for either CAR outcome .
-RESULTS	However , a significant gender by treatment response interaction for cortisol reactivity revealed that female treatment nonresponders displayed higher cortisol reactivity following treatment than female responders , whereas cortisol reactivity did not change pre - to posttreatment for male responders .
-RESULTS	Findings remained after controlling for age , trauma history , baseline medication status , baseline PTSD , and baseline depressive symptoms .
-CONCLUSIONS	Loss of a PTSD diagnosis may contribute to decreased cortisol reactivity in females .
-CONCLUSIONS	Neuroendocrine changes following treatment may emerge only for specific subgroups , highlighting the importance of exploring treatment moderators .
-
-###25644221
-BACKGROUND	Abundant evidence suggests that allelic variation in the serotonin transporter-linked polymorphic region ( 5-HTTLPR ) influences susceptibility to stress and its affective consequences due to brain serotonergic vulnerability .
-BACKGROUND	Based on recent assumptions , the present study examined whether the 5-HTTLPR genotype may also interact with a vulnerability to chronic stress experience ( conceptualized by trait neuroticism ) in order to influence sleep quality and , additionally , whether this is influenced by brain serotonergic manipulations .
-METHODS	In a well-balanced experimental design , homozygous S-allele ( n = 57 ) and L-allele ( n = 54 ) genotypes with high and low chronic stress vulnerability ( neuroticism ) were first assessed for general past sleep quality during a month before onset of the experiment .
-METHODS	Then subjects were assessed for sleep quality following 7 days of tryptophan ( 3.0 g/day ) or placebo intake .
-RESULTS	Although high neuroticism was significantly related to a higher frequency of stressful life events and daily hassles , it did not interact with the 5-HTTLPR genotype on general past sleep quality .
-RESULTS	However , as expected , a 7 day period of tryptophan administration was exclusively associated with better sleep quality scores in the S ' / S ' genotype with high trait neuroticism .
-CONCLUSIONS	Current findings suggest that 5-HTTLPR does not directly interact with stress vulnerability in order to influence sleep quality .
-CONCLUSIONS	Instead , based on current and previous findings , it is suggested that the S ' / S ' 5-HTTLPR genotype promotes the risk for stress-related sleep disturbances because of an increased susceptibility to the depressogenic consequences of stress .
-CONCLUSIONS	Accordingly , by way of reducing depressive symptomatology , tryptophan augmentation may particularly improve sleep quality in stress-vulnerable individuals carrying the 5-HTTLPR S-allele .
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-###25911762
-OBJECTIVE	By using orthogonal design method to optimnize prescription of pulsed electric field at Jiaji ( EX - B 2 ) points for spinal cord injury ( SCI ) .
-METHODS	Fifty six patients of SCI were selected , in which 36 cases were divided into orthogonal design trial and 20 cases were into clinical verification .
-METHODS	With 36 patients who received orthogonal design trial , Frankel grading scale was used as observation index to screen optimal prescription of pulsed electric field .
-METHODS	Pulse frequency ( factor A ) included low frequency ( factor A ( I ) , 10 ( 2 ) Hz ) .
-METHODS	moderate frequency ( factor A ( II ) , 10 ( 4 ) Hz ) and high frequency ( factor A ( III ) , 10 ( 3 ) Hz ) ; pulse amplitude ( factor B ) included 0-30 V ( factor B ) , 0-60 V ( factor B ( II ) ) and 0-90 V ( factor B ( III ) ) ; pulse width ( factor C ) included 0.1 ms ( factor C ( I ) ) .
-METHODS	0.6 ms ( factor C ( II ) ) and 0.9 ms ( factor C ( III ) ) ; acupuncture time ( factor D ) included one month ( DI ) , three months ( D ( II ) ) and five months ( D ( III ) ) .
-METHODS	Twenty patients were used for clinical efficacy observation and the effects of screened optimal pre scription of pulsed electric field at Jiaji ( EX-B 2 ) points combined with regular rehabilitation training on spasm se - verity , score of sensory and motor functions , Barthel index and Frankel score were observed .
-RESULTS	( 1 ) As results of orthogonal design trial , the optimal prescription was A ( III ) B ( III ) , C ( I ) , D ( III ) , which were high frequency ( 10 ( 3 ) Hz ) , 0-90 V of pulse amplitude , 0.4 ms of pulse width and 5 months of treatment time .
-RESULTS	( 2 ) As results of 20 patient clinical verification , Ashworth score , tendon reflex and clonus were all significantly improved ( P < 0.001 , P < 0.01 ) , the scores of sensory and motor functions were evidently improvedtl ( P < 0.001 , P < 0.05 ) , and Barthel in dex and Frankel score were also enhanced ( P < 0.001 , P < 0.05 ) .
-CONCLUSIONS	The optimal prescription of pulsed electric field at Jiaji ( EX-B 2 ) points for spinal cord injury is high frequency ( 10 & Hz ) , 0-90 V of pulse amplitude , 0.4 ms of pulse width and 5 months of treatment time .
-CONCLUSIONS	The optimal prescription of pulsed electric field at Jiaji ( EX-B 2 ) points combined with regular rehabilitation could obviously improve spasm severity , enhance senso - ry and motor functions , and ameliorate activity of daily life and Frankel score .
-
-###26427109
-OBJECTIVE	To compare the impacts of electroacu puncture ( EA ) and moxibustion ( Mox ) on the prima ry gastrointestinal symptoms and the expressions of colonic mucosa-associated neuropeptide substance P ( SP ) and vasoactive intestinal peptide ( VIP ) in patients with either diarrhea-predominant or constipation-predominant irritable bowel syndrome ( IBS-D and IBS-C , respectively ) .
-METHODS	Eighty-five IBS patients were randomly allocated to the EA and Mox groups .
-METHODS	Zusanli ( ST 36 ) and Shangjuxu ( ST 37 ) were selected as acupoints for electroacupuncture or warm moxibustion treatment once a day for 14 consecutive days .
-METHODS	Before and after the treatment sessions , a Visual Analog Pain Scale and the Bristol Stool Form Scale were used to evaluate gastrointestinal symptoms .
-METHODS	There were four dropout cases , leaving 81 participants ( 41 with IBS-D and 40 with IBS-C ) who volunteered to undergo colonoscopy before and after the treatment sessions .
-METHODS	During colonoscopy , sigmoid mucosa were collected to detect SP and VIP expression using immunohistochemistry assay .
-RESULTS	Both EA and Mox treatments were effective at relieving abdominal pain in IBS-D and IBS-C patients .
-RESULTS	However , Mox was more effective at reducing diarrhea in IBS-D patients , whereas EA was more effective at improving constipation in IBS-C patients .
-RESULTS	EA and Mox treatments both down-regulated the abnormally increased SP and VIP expression in the colonic mucosa , with no significant difference shown between the two treatments .
-CONCLUSIONS	Both EA and Mox treatments are effective at ameliorating gastrointestinal symptoms by reducing SP and VIP expression in the colonic mucosa of IBS patients .
-
-###24939678
-OBJECTIVE	The aim of this study was to assess the usefulness of colour duplex sonography ( CDS ) - guided temporal artery biopsy ( TAB ) for the diagnosis of GCA in patients with suspected GCA .
-METHODS	From September 2009 through December 2012 , 112 consecutive patients with suspected GCA were randomized to undergo CDS-guided TAB or standard TAB .
-METHODS	All patients underwent temporal artery physical examination and temporal artery CDS prior to TAB .
-METHODS	CDS of the temporal artery was performed by the same ultrasonographer , who was unaware of the patient 's clinical data , and all TABs were evaluated by the same pathologist .
-METHODS	Seven patients in whom biopsy failed to sample temporal artery tissue were excluded from the analysis .
-RESULTS	Fifty patients were randomized to undergo CDS-guided TAB and 55 patients to standard TAB .
-RESULTS	Except for a younger age in patients who underwent standard TAB ( P = 0.026 ) , no significant differences were observed between the two groups .
-RESULTS	There were no significant differences in the frequencies of positive TAB for classic transmural inflammation ( 28 % vs 18.2 % ) or for periadventitial small vessel vasculitis and/or vasa vasorum vasculitis ( 6 % vs 14.5 % ) between the two groups .
-RESULTS	No significant differences in the frequency of positive TAB in the two groups were observed when we excluded the patients treated with glucocorticoids and when we stratified the patients of the two groups for the presence or absence of the halo sign .
-CONCLUSIONS	Our study showed that CDS-guided TAB did not improve the sensitivity of TAB for diagnosing GCA .
-
-###24815298
-BACKGROUND	The importance of interactions between the host and gut microbiota in the pathogenesis of irritable bowel syndrome ( IBS ) is becoming increasingly apparent .
-BACKGROUND	Probiotics offer a potential new treatment for IBS , but current results are conflicting , largely as a result of poorly designed trials and nonstandardisation of outcome measures .
-OBJECTIVE	To assess the efficacy of a liquid , multi-strain probiotic ( Symprove ) in IBS .
-METHODS	A single-centre , randomised , double-blind , placebo-controlled trial of adult patients with symptomatic IBS .
-METHODS	Patients received 12 weeks of treatment with the probiotic or placebo ( 1 mL/kg/day ) .
-METHODS	The primary efficacy measure was the difference in change in the IBS symptom severity score ( IBS-SSS ) between probiotic vs. placebo at week 12 .
-METHODS	Secondary outcome measures included change in the IBS quality of life ( IBS-QOL ) score and change in the IBS-SSS symptom component scores .
-RESULTS	A total of 186 patients were randomised and 152 patients completed the study .
-RESULTS	The mean change in IBS-SSS was -63.3 probiotic vs. -28.3 placebo .
-RESULTS	The mean difference in the IBS-SSS was statistically significant [ -35.0 ( 95 % CI ; -62.03 , -7.87 ) ; P = 0.01 ] .
-RESULTS	There was no significant improvement in the IBS-QOL .
-RESULTS	No serious adverse events were reported .
-CONCLUSIONS	The multi-strain probiotic was associated with a statistically significant improvement in overall symptom severity in patients with IBS , and was well tolerated .
-CONCLUSIONS	These results suggest this probiotic confers benefit in IBS and deserves further investigation ( ISRCTN identifier : 77512412 ) .
-
-###24740826
-OBJECTIVE	Bevacizumab , a humanized monoclonal antibody against vascular endothelial growth factor , has shown increased pathological complete response rates when added to neoadjuvant chemotherapy .
-OBJECTIVE	In various cancer types , bevacizumab treatment was accompanied by an increased risk of bleedings and other surgical complications .
-OBJECTIVE	We assessed associated surgical complications .
-METHODS	In the GeparQuinto trial , 1,948 patients were randomized to receive four cycles epirubicin/cyclophosphamide ( EC , 90/600mg/m ( 2 ) q3w ) followed by four cycles docetaxel ( D , 100mg/m ( 2 ) q3w ) each with ( ECB-DB ) or without ( EC-D ) bevacizumab ( B , 15mg/kg q3w ) concurrent with chemotherapy .
-METHODS	Surgery had to be performed not earlier than 28days after the last bevacizumab infusion , but within days 21 and 35 after the last chemotherapy .
-RESULTS	In 743 ( 38.1 % ) patients , a surgical complication ( bleedings , hematomas , necrosis , wound infections , abscess ) was documented prospectively .
-RESULTS	Baseline characteristics of the patients were well balanced between both arms .
-RESULTS	The breast-conserving surgery ( BCS ) rate ( N = 502 ) was 69.1 % ( EC-D ) and 71.9 % ( ECB-DB ; p = 0.464 ) .
-RESULTS	The first surgical procedure was performed at a median of 29 ( EC-D ) and 34days ( ECB-DB ) after last chemotherapy with or without bevacizumab infusion ( p < 0.001 ) .
-RESULTS	Surgical complications were documented in 38 ( 10.9 % ; EC-D ) and 59 ( 15.0 % ; ECB-DB ) patients ( p = 0.103 ) .
-RESULTS	Surgical complications were significantly higher after ECD-DB only in patients treated with BCS ( N = 53 ; p = 0.029 ) or in those requiring repeat surgery in order achieve clear margins ( N = 23 ; p = 0.037 ) compared to the EC-D group .
-CONCLUSIONS	Addition of bevacizumab to neoadjuvant chemotherapy might be associated with an increased risk for surgical complications in patients treated with BCS or after repeated surgeries .
-
-###24557989
-BACKGROUND	Whether convective therapies allow better control of serum phosphate ( P ) is still undefined , and no data are available concerning on-line haemofiltration ( HF ) .
-BACKGROUND	The objectives of the study are to evaluate the effect of convective treatments ( CTs ) on P levels in comparison with low-flux haemodialysis ( HD ) and to evaluate the correlates of serum phosphate in a post hoc analysis of a randomized clinical trial .
-METHODS	This analysis was performed in the database of a multicentre , open label and randomized controlled study in which 146 chronic HD patients from 27 Italian centres were randomly assigned to HD ( 70 patients ) or CTs : on-line pre-dilution HF ( 36 patients ) or on-line pre-dilution haemodiafiltration ( 40 patients ) .
-RESULTS	CTs did not affect P ( P = 0.526 ) , calcium ( Ca ) ( P = 0.849 ) and parathyroid hormone levels ( P = 0.622 ) .
-RESULTS	P levels were associated with the use of phosphate binders including aluminium-based phosphate binders ( P < 0.001 ) and sevelamer ( P < 0.001 ) , pre-dialysis bicarbonate levels ( P < 0.001 ) and pre-dialysis blood K levels ( P < 0.001 ) .
-RESULTS	On multivariate analysis ( generalized linear model ) , serum P was again largely unassociated with CTs ( P = 0.631 ) .
-RESULTS	Notably , participating centres were by far the strongest independent correlate of serum P , explaining 45.3 % of the variance of serum P over the trial and this association was confirmed at multivariate analysis .
-RESULTS	Bicarbonate ( P < 0.001 ) and , to a weaker extent , serum K ( P = 0.032 ) were independently related to serum P.
-CONCLUSIONS	In comparison with low-flux HD , CTs did not significantly affect serum P levels .
-CONCLUSIONS	Participating centres were the main source of P variability during the trial followed by treatment with phosphate binders , serum bicarbonate and , to a weak extent , serum potassium levels ( ClinicalTrials.gov Identifier : NCT011583309 ) .
-
-###24618231
-BACKGROUND	Fine particulate matter ( PM ) air pollution is associated with numerous adverse health effects , including increased blood pressure ( BP ) and vascular dysfunction .
-BACKGROUND	Coarse PM substantially contributes to global air pollution , yet differs in characteristics from fine particles and is currently not regulated .
-BACKGROUND	However , the cardiovascular ( CV ) impacts of coarse PM exposure remain largely unknown .
-OBJECTIVE	Our goal was to elucidate whether coarse PM , like fine PM , is itself capable of eliciting adverse CV responses .
-METHODS	We performed a randomized double-blind crossover study in which 32 healthy adults ( 25.9 6.6 years of age ) were exposed to concentrated ambient coarse particles ( CAP ; 76.2 51.5 g/m ( 3 ) ) in a rural location and filtered air ( FA ) for 2 hr .
-METHODS	We measured CV outcomes during , immediately after , and 2 hr postexposures .
-RESULTS	Both systolic ( mean difference = 0.32 mmHg ; 95 % CI : 0.05 , 0.58 ; p = 0.021 ) and diastolic BP ( 0.27 mmHg ; 95 % CI : 0.003 , 0.53 ; p = 0.05 ) linearly increased per 10 min of exposure during the inhalation of coarse CAP when compared with changes during FA exposure .
-RESULTS	Heart rate was on average higher ( 4.1 bpm ; 95 % CI : 3.06 , 5.12 ; p < 0.0001 ) and the ratio of low-to-high frequency heart rate variability increased ( 0.24 ; 95 % CI : 0.07 , 0.41 ; p = 0.007 ) during coarse particle versus FA exposure .
-RESULTS	Other outcomes ( brachial flow-mediated dilatation , microvascular reactive hyperemia index , aortic hemodynamics , pulse wave velocity ) were not differentially altered by the exposures .
-CONCLUSIONS	Inhalation of coarse PM from a rural location is associated with a rapid elevation in BP and heart rate during exposure , likely due to the triggering of autonomic imbalance .
-CONCLUSIONS	These findings add mechanistic evidence supporting the biological plausibility that coarse particles could contribute to the triggering of acute CV events .
-
-###24462484
-OBJECTIVE	There have been repeated calls from health professionals and policy-makers to clarify the side-effects of the increasingly popular consumption trend of alcohol mixed with energy drinks ( AmED ) .
-OBJECTIVE	There is a dearth of research assessing the differential effects of AmED relative to alcohol by comparing self-reported psychological and physiological outcomes whilst under the influence of these substances .
-OBJECTIVE	The aim of the present study was to examine the acute effects of a moderate alcohol and energy drink ( ED ) dose on self-reported psychological and physiological outcomes .
-METHODS	Using a single-blind , placebo-controlled , crossover design , 28 adults completed four sessions where they were administered : ( i ) 0.50 g/kg alcohol , ( ii ) 3.57 mL/kg ED , ( iii ) AmED , and ( iv ) placebo .
-METHODS	Participants independently completed the Profile of Mood States and a Somatic Symptom Scale at baseline and at 30 and 125min after beverage administration .
-RESULTS	Breath alcohol concentration peaked at .068 % and .067 % in the alcohol and AmED conditions , respectively .
-RESULTS	There were no interactive alcohol and ED effects on self-reported psychological outcomes .
-RESULTS	Treatment effects for physiological outcomes generally only related to alcohol or ED administration , with the exception of a moderate magnitude decrease in heart palpitation ratings following alcohol relative to AmED .
-RESULTS	Decreased muscular tension ratings were evident when the two constituents were consumed separately relative to placebo .
-CONCLUSIONS	The results provide evidence of few subjective changes in physiological and psychological state after consuming AmED relative to alcohol .
-CONCLUSIONS	The majority of treatment-based changes arose from the independent effects of alcohol or ED , rather than being modified by their interaction .
-CONCLUSIONS	However , research extending into higher dosage domains is required to increase outcome generalisability for consumers in the night-time economy .
-
-###25037462
-OBJECTIVE	This randomized , controlled , single-blinded multicenter study evaluated the efficacy of latest-generation fibrin sealant containing synthetic aprotinin as fibrinolysis inhibitor as supportive treatment for hemostasis after elective partial hepatectomy .
-METHODS	Adult subjects undergoing resection of at least one liver segment were assigned to treatment with fibrin sealant or manual compression with a surgical gauze swab if persistent oozing necessitated additional hemostatic measures after primary control of arterial and venous bleeding .
-METHODS	The primary outcome measure was the proportion of subjects with intraoperative hemostasis at 4 min after start of randomized treatment application .
-METHODS	Secondary efficacy outcome measures included intraoperative hemostasis at 6 , 8 , and 10 min , intra - and postoperative rebleedings , transfusion requirements , and drainage volume .
-RESULTS	Seventy subjects were randomized .
-RESULTS	Hemostasis at 4 min was achieved in 29/35 ( 82.9 % ) fibrin sealant subjects compared with 13/35 ( 37.1 % ) control subjects ( p < 0.001 ) .
-RESULTS	Significantly more fibrin sealant subjects achieved hemostasis at 6 ( p < 0.001 ) , 8 ( p = 0.028 ) , and 10 min ( p = 0.017 ) .
-RESULTS	The number of rebleedings was low in both study arms .
-RESULTS	Transfusion requirements and 48-h drainage volumes were similar between the study arms .
-RESULTS	No adverse events related to study treatment were reported .
-CONCLUSIONS	Fibrin sealant was shown to be safe and superior to manual compression in the control of parenchymal bleeding after hepatic resection .
-CONCLUSIONS	The use of synthetic aprotinin as fibrinolysis inhibitor further improves the safety margin of fibrin sealant by eliminating the risk of transmission of bovine spongiform encephalopathy and other bovine pathogens .
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-###24985779
-BACKGROUND	Whether early antiretroviral therapy ( ART ) initiation could impact sexual risk behaviours remains to be documented .
-BACKGROUND	We aimed to investigate changes in sexual behaviours within the 24 months following an early versus standard ART initiation in HIV-positive adults with high CD4 counts .
-METHODS	We used data from a prospective behavioural study nested in a randomized controlled trial of early ART ( Temprano-ANRS12136 ) .
-METHODS	Time trends in sexual behaviours from enrolment in the trial ( M0 ) to 12-month ( M12 ) and 24-month ( M24 ) visits were measured and compared , using Generalized Estimating Equations models , between participants randomly assigned either to initiate ART immediately ( early ART ) or to defer ART initiation until on-going WHO starting criteria are met ( standard ART ) .
-METHODS	Indicators of sexual behaviours included 1 ) sexual activity in the past year , 2 ) multiple partnership in the past year , 3 ) unprotected sex at last intercourse and 4 ) risky sex ( i.e. unprotected sex with a partner of HIV negative/unknown status ) at last intercourse .
-RESULTS	Analyses included 1952 participants ( 975 with early ART and 977 with standard ART ; overall median baseline CD4 count : 469/mm ( 3 ) ) .
-RESULTS	Among participants with early ART , significant decreases were found between M0 and M24 in sexual activity ( Odds Ratio [ OR ] 0.72 , 95 % Confidence Interval [ 95 % CI ] 0.57-0 .92 ) , multiple partnership ( OR 0.57 , 95 % CI 0.41-0 .79 ) , unprotected sex ( OR 0.59 , 95 % CI 0.47-0 .75 ) and risky sex ( OR 0.58 , 95 % CI 0.45-0 .76 ) .
-RESULTS	Among participants with standard ART , sexual behaviours showed similar trends over time .
-RESULTS	These decreases mostly occurred within the 12 months following enrolment in the trial in both groups and prior to ART initiation in participants with standard ART .
-RESULTS	For unprotected sex and risky sex , decreases were or tended to be more pronounced among patients reporting that their last sexual partner was non-cohabiting .
-CONCLUSIONS	In these sub-Saharan adults with high CD4 counts , entry into HIV care , rather than ART initiation , resulted in decreased sexual activity and risky sexual behaviours .
-CONCLUSIONS	We did not observe any evidence of a risk compensation phenomenon associated with early ART initiation .
-CONCLUSIONS	These results illustrate the potential behavioural preventive effect of early entry into care , which goes hand in hand with early ART initiation .
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-###24326980
-BACKGROUND	Oropharyngeal dysphagia ( OD ) is a major gastrointestinal motility disorder that causes severe nutritional and respiratory complications in elderly and neurological patients .
-BACKGROUND	In an earlier study , we found that stimulation of pharyngeal sensory neurons by capsaicinoids acting on transient receptor potential vanilloid 1 ( TRPV1 ) improved the swallow response of dysphagic patients .
-BACKGROUND	The aim of this study was to explore the effect of piperine , a dual TRPV1/TRPA1 agonist , on the swallow response of dysphagic patients .
-METHODS	A videofluoroscopic study was performed to assess the signs of impaired safety and efficacy of swallow and the swallow response of 40 dysphagic patients while swallowing one series of nectar control boluses and two series of nectar boluses supplemented with piperine .
-METHODS	Patients were randomized into two groups : one group received 150 M piperine and the other group received 1 mM .
-RESULTS	Piperine improved the safety of swallow by : ( a ) reducing the prevalence of unsafe swallows by -34.48 % ( P = 0.004 ) at 150 M and -57.19 % ( P < 0.001 ) at 1 mM , and the severity score of the penetration-aspiration scale from 3.25 0.51 to 1.85 0.27 ( P = 0.003 , 1 mM ) ; and ( b ) shortening the time to laryngeal vestibule closure from 0.366 0.024 to 0.270 0.022 s with 150 M piperine ( P < 0.001 ) and from 0.380 0.032 to 0.306 0.028 s with 1 mM piperine ( P < 0.05 ) .
-CONCLUSIONS	Supplementing the alimentary bolus with piperine speeds swallow response and strongly improves safety of swallow in patients with OD , with a maximal therapeutic effect at 1 mM .
-CONCLUSIONS	Our results suggest that activation of TRPV1/A1 in oropharyngeal sensory neurons is a very promising neurostimulation strategy for dysphagic patients .
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-###24316262
-OBJECTIVE	We performed an open-label , multicenter , phase 3 study of the safety and efficacy of twice-daily telaprevir in treatment-naive patients with chronic hepatitis C virus ( HCV ) genotype 1 infection , including those with cirrhosis .
-METHODS	Patients were randomly assigned to groups treated with telaprevir 1125 mg twice daily or 750 mg every 8 hours plus peginterferon alfa-2a and ribavirin for 12 weeks ; patients were then treated with peginterferon alfa-2a and ribavirin alone for 12 weeks if their level of HCV RNA at week 4 was < 25 IU/mL or for 36 weeks if their level was higher .
-METHODS	The primary objective was to demonstrate noninferiority of telaprevir twice daily versus every 8 hours in producing a sustained virological response 12 weeks after the end of therapy ( SVR12 ) ( based on a -11 % lower limit of the 95 % lower confidence interval for the difference between groups ) .
-RESULTS	At baseline , of 740 patients , 85 % had levels of HCV RNA 800,000 IU/mL , 28 % had fibrosis ( F3-F4 ) , 14 % had cirrhosis ( F4 ) , 57 % were infected with HCV genotype 1a , and 71 % had the non-CC IL28B genotype .
-RESULTS	Of patients who were treated with telaprevir twice daily , 74.3 % achieved SVR12 compared with 72.8 % of patients who were treated with telaprevir every 8 hours ( difference in response , 1.5 % ; 95 % confidence interval , -4.9 % to 12.0 % ) , so telaprevir twice daily is noninferior to telaprevir every 8 hours .
-RESULTS	All subgroups of patients who were treated with telaprevir twice daily versus those who were treated every 8 hours had similar rates of SVR12 .
-RESULTS	The most frequent adverse events ( AEs ) in the telaprevir phase were fatigue ( 47 % ) , pruritus ( 43 % ) , anemia ( 42 % ) , nausea ( 37 % ) , rash ( 35 % ) , and headache ( 26 % ) ; serious AEs were reported in 9 % of patients .
-RESULTS	Rates of AEs and serious AEs were similar or slightly higher among patients treated with telaprevir every 8 hours .
-CONCLUSIONS	Based on a phase 3 trial , telaprevir twice daily is noninferior to every 8 hours in producing SVR12 , with similar levels of safety and tolerability .
-CONCLUSIONS	These results support use of telaprevir twice daily in patients with chronic HCV genotype 1 infection , including those with cirrhosis .
-CONCLUSIONS	ClinicalTrials.gov , Number : NCT01241760 .
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-###24885354
-BACKGROUND	Radiotherapy has a good effect in palliation of painful bone metastases , with a pain response rate of more than 60 % .
-BACKGROUND	However , shortly after treatment , in approximately 40 % of patients a temporary pain flare occurs , which is defined as a two-point increase of the worst pain score on an 11-point rating scale compared to baseline , without a decrease in analgesic intake , or a 25 % increase in analgesic intake without a decrease in worst pain score , compared to baseline .
-BACKGROUND	A pain flare has a negative impact on daily functioning and mood of patients .
-BACKGROUND	It is thought to be caused by periostial edema after radiotherapy .
-BACKGROUND	Dexamethasone might diminish this edema and thereby reduce the incidence of pain flare .
-BACKGROUND	Two non-randomized studies suggest that dexamethasone reduces the incidence of a pain flare by 50 % .
-BACKGROUND	The aim of this trial is to study the effectiveness of dexamethasone to prevent a pain flare after palliative radiotherapy for painful bone metastases and to determine the optimal dose schedule .
-METHODS	This study is a three-armed , double-blind , placebo-controlled multicenter trial .
-METHODS	We aim to include 411 patients with uncomplicated painful bone metastases from any type of primary solid tumor who receive short schedule radiotherapy ( all conventional treatment schedules from one to six fractions ) .
-METHODS	Arm 1 consists of daily placebo for four days , arm 2 starts with 8mg dexamethasone before the ( first ) radiotherapy and three days placebo thereafter .
-METHODS	Arm 3 consists of four days 8mg dexamethasone .
-METHODS	The primary endpoint is the occurrence of a pain flare .
-METHODS	Secondary endpoints are pain , quality of life and side-effects of dexamethasone versus placebo .
-METHODS	Patients complete a questionnaire ( Brief Pain Inventory with two added questions about side-effects of medication , the EORTC QLQ-C15-PAL and QLQ-BM22 for quality of life ) at baseline , daily for two weeks and lastly at four weeks .
-CONCLUSIONS	This study will show whether dexamethasone is effective in preventing a pain flare after palliative radiotherapy for painful bone metastases and , if so , to determine the optimal dose .
-BACKGROUND	This study is registered at ClinicalTrials.gov : NCT01669499 .
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-###25938633
-BACKGROUND	HIV infection is associated with a greater risk for fasting hyperinsulinemia , impaired glucose tolerance , and higher incidence rates for vascular disease , myocardial infarction , or stroke despite effective combination antiretroviral therapy ( cART ) .
-BACKGROUND	The underlying mechanism ( s ) may involve chronic low-grade systemic inflammation and immune cell activation .
-BACKGROUND	Dipeptidyl peptidase-4 inhibitors ( sitagliptin ) improve glucose tolerance and may possess immunomodulatory effects because leukocyte CD26 cell surface receptors express dipeptidyl peptidase-4 activity .
-OBJECTIVE	Sitagliptin will reduce inflammatory and immune cell activation markers known to be elevated in cART-treated HIV-infected ( HIV + ) adults with impaired glucose tolerance .
-METHODS	This was designed as a prospective , randomized , placebo-controlled , double-blind trial of sitagliptin in HIV + adults .
-METHODS	The setting was an academic medical center .
-METHODS	Patients were cART-treated HIV + men and women ( n = 36 ) with stable HIV disease and impaired glucose tolerance .
-METHODS	Interventions included sitagliptin 100 mg/d or placebo for 8 weeks .
-METHODS	At baseline and week 8 , plasma high-sensitivity C-reactive protein and C-X-C motif chemokine 10 concentrations ( ELISA ) , oral glucose tolerance , and abdominal sc adipose mRNA expression for M1 macrophage markers ( monocyte chemotactic protein-1 , EGF-like module-containing , mucin-like hormone receptor 1 ) .
-RESULTS	Sitagliptin reduced glucose area under the curve ( P = .002 ) and improved oral glucose insulin sensitivity index ( P = .04 ) more than placebo .
-RESULTS	Sitagliptin reduced plasma high-sensitivity C-reactive protein and C-X-C motif chemokine 10 levels more than placebo ( P < .009 ) .
-RESULTS	Adipose tissue monocyte chemotactic protein-1 mRNA abundance declined significantly more ( P = .01 ) , and adipose EGF-like module-containing , mucin-like hormone receptor 1 mRNA expression tended to decline more ( P = .19 ) in sitagliptin than placebo .
-CONCLUSIONS	Sitagliptin had beneficial systemic and adipose anti-inflammatory effects in cART-treated HIV + adults with impaired glucose tolerance .
-CONCLUSIONS	Large-scale , long-term studies should determine whether sitagliptin reduces cardiovascular risk and events in HIV + adults .
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-###25108752
-OBJECTIVE	The purpose of this study was to compare the effects of manual therapy with exercise to kinesiotaping with exercise for patients with subacromial impingement syndrome .
-METHODS	Randomized clinical before and after trial was used .
-METHODS	Fifty-four patients diagnosed as having subacromial impingement syndrome who were referred for outpatient treatment were included .
-METHODS	Eligible patients ( between 30 and 60 years old , with unilateral shoulder pain ) were randomly allocated to 2 study groups : kinesiotaping with exercise ( n = 28 ) or manual therapy with exercise ( n = 26 ) .
-METHODS	In addition , patients were advised to use cold packs 5 times per day to control for pain .
-METHODS	Visual analog scale for pain , Disability of Arm and Shoulder Questionnaire for function , and diagnostic ultrasound assessment for supraspinatus tendon thickness were used as main outcome measures .
-METHODS	Assessments were applied at the baseline and after completing 6 weeks of related interventions .
-RESULTS	At the baseline , there was no difference between the 2 group characteristics ( P > .05 ) .
-RESULTS	There were significant differences in both groups before and after treatment in terms of pain decrease and improvement of Disability of Arm and Shoulder Questionnaire scores ( P < .05 ) .
-RESULTS	No difference was observed on ultrasound for tendon thickness after treatment in both groups ( P > .05 ) .
-RESULTS	The only difference between the groups was at night pain , resulting in favor of the kinesiotaping with exercise group ( P < .05 ) .
-CONCLUSIONS	For the group of subjects studied , no differences were found between kinesiotaping with exercise and manual therapy with exercise .
-CONCLUSIONS	Both treatments may have similar results in reducing pain and disability in subacromial impingement in 6 weeks .
-
-###24886676
-BACKGROUND	Men who undergo surgery for prostate cancer frequently experience significant side-effects including urinary and sexual dysfunction .
-BACKGROUND	These difficulties can lead to anxiety , depression and reduced quality of life .
-BACKGROUND	Many partners also experience psychological distress .
-BACKGROUND	An additional impact can be on the couple relationship , with changes to intimacy , and unmet psychosexual supportive needs in relation to sexual recovery and rehabilitation .
-BACKGROUND	The aim of this exploratory randomised controlled trial pilot study is to determine the feasibility and acceptability of a novel family-relational-psychosexual intervention to support intimacy and reduce distress among couples following prostate cancer surgery and to estimate the efficacy of this intervention .
-METHODS	The intervention will comprise six sessions of psychosexual and relationship support delivered by experienced couple-support practitioners .
-METHODS	Specialist training in delivering the intervention will be provided to practitioners and they will be guided by a detailed treatment manual based on systemic principles .
-METHODS	Sixty-eight couples will be randomised to receive either the intervention or standard care ( comprising usual follow-up hospital appointments ) .
-METHODS	A pre-test , post-test design will be used to test the feasibility of the intervention ( baseline , end of intervention and six-month follow-up ) and its acceptability to couples and healthcare professionals ( qualitative interviews ) .
-METHODS	Both individual and relational outcome measures will assess sexual functioning , anxiety and depression , couple relationship , use of health services and erectile dysfunction medication/technologies .
-METHODS	An economic analysis will estimate population costs of the intervention , compared to usual care , using simple modelling to evaluate the affordability of the intervention .
-CONCLUSIONS	Given the increasing incidence and survival of post-operative men with prostate cancer , it is timely and appropriate to determine the feasibility of a definitive trial through a pilot randomised controlled trial of a family-relational-psychosexual intervention for couples .
-CONCLUSIONS	The study will provide evidence about the components of a couple-based intervention , its acceptability to patients and healthcare professionals , and its influence on sexual and relational functioning .
-CONCLUSIONS	Data from this study will be used to calculate sample sizes required for any definitive trial .
-BACKGROUND	ClinicalTrials.gov Identifier : NCT01842438.Registration date : 24 April 2013 ; Randomisation of first patient : 13 May 2013 .
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-###24606601
-BACKGROUND	The possibility of living well with a long-term condition has been identified as centrally relevant to the needs of people living with dementia .
-BACKGROUND	Growing numbers of people with early-stage dementia are contributing accounts that emphasise the benefits of actively engaging in managing the condition .
-BACKGROUND	Self-management interventions share the common objectives of educating about the condition , optimising well-being , enhancing control over the situation and enabling people to take more responsibility for managing the condition .
-BACKGROUND	Benefits of such an approach can include improved knowledge , self-efficacy , health status , and better performance of self-management behaviours .
-BACKGROUND	However , there is only preliminary evidence that people with early-stage dementia can benefit from such interventions .
-METHODS	This feasibility study involves the development of a self-management group intervention for people with early-stage Alzheimer 's disease , vascular dementia or mixed Alzheimer 's and vascular dementia .
-METHODS	This study is a single-site pilot randomised-controlled trial .
-METHODS	Forty-two people with early stage dementia , each with a caregiver ( family member/friend ) , will be randomised to either the self-management group intervention or to treatment as usual.The self-management group intervention will involve eight weekly sessions , each lasting 90 minutes , held at a memory clinic in North Wales .
-METHODS	All participants will be re-assessed three and six months post-randomisation .
-METHODS	This study is intended to supply an early evaluation of the self-management intervention so that a full scale trial may be powered from the best available evidence .
-METHODS	It will assess the feasibility of the intervention , the study design and the recruitment strategies .
-METHODS	It will estimate the parameters and confidence intervals for the research questions of interest .
-METHODS	The primary outcome of interest is the self-efficacy score of the person with dementia at three months post-randomisation .
-METHODS	Secondary outcomes for the person with dementia are self-efficacy at six months post-randomisation and cognitive ability , mood and well-being at three and six months post-randomisation .
-METHODS	Secondary outcomes for caregivers are their distress and stress at three and six months post-randomisation .
-METHODS	The cost-effectiveness of the intervention will also be examined .
-CONCLUSIONS	This study will provide preliminary information about the feasibility , efficacy and cost-effectiveness of a self-management group intervention for people in the early stages of dementia .
-BACKGROUND	Current Controlled Trials , ISRCTN02023181 .
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-###24720535
-BACKGROUND	Inflammation may contribute to the high cardiovascular risk in diabetes mellitus ( DM ) and chronic kidney disease ( CKD ) .
-BACKGROUND	Monocyte chemoattractant protein-1 ( MCP-1 ) facilitates the recruitment of monocytes into atherosclerotic lesions and is involved in diabetic nephropathy .
-BACKGROUND	Interferon gamma ( IFN ) is important in atherosclerosis and increases the synthesis of chemokines including MCP-1 .
-BACKGROUND	Lipid-lowering treatment ( LLT ) with statins may have anti-inflammatory effects , and ezetimibe cotreatment provides additional cholesterol lowering .
-METHODS	After a placebo run-in period , the effects of simvastatin alone ( S ) or simvastatin + ezetimibe ( S+E ) were compared in a randomized , double-blind , cross-over study on inflammatory parameters .
-METHODS	Eighteen DM patients with estimated glomerular filtration rate ( eGFR ) 15-59mL / min173m ( 2 ) ( CKD stages 3-4 ) ( DM-CKD ) and 21 DM patients with eGFR > 75mL/min ( DM only ) were included .
-RESULTS	At baseline , monocyte chemoattractant protein 1 ( MCP-1 ) ( P = 003 ) , IFN ( P = 002 ) , tumour necrosis factor - ( TNF ) ( P < 001 ) and soluble vascular adhesion molecule ( sVCAM ) ( P = 0001 ) levels were elevated in DM-CKD compared with DM-only patients .
-RESULTS	LLT with S and S+E reduced MCP-1 levels ( P < 001 by anova ) and IFN levels ( P < 001 ) in DM-CKD patients but not in DM-only patients .
-RESULTS	Reductions were most pronounced with the combination treatment .
-CONCLUSIONS	DM patients with CKD stages 3-4 had increased inflammatory activity compared with DM patients with normal GFR .
-CONCLUSIONS	Lipid-lowering treatment decreased the levels of MCP-1 and IFN in DM patients with concomitant CKD , which may be beneficial with regard to the progression of both atherosclerosis and diabetic nephropathy .
-
-###24531987
-BACKGROUND	Social connections at all stages of life are essential for physical and mental well-being .
-BACKGROUND	Of particular importance are social relationships during adolescence that shape adult health behaviors and health outcomes .
-OBJECTIVE	The aim of this study was to estimate the association between adolescent peer status in school and later-life quality-adjusted life-years ( QALYs ) and healthcare costs .
-METHODS	This study used social network and health outcomes data from Wave I ( ages 12-18years ) and Wave III ( ages 18-24years ) of the US National Longitudinal Study of Adolescent Health ( n = 10,578 ) to compare QALYs and healthcare costs ( in 2012 US$ ) by adolescent peer status in US schools .
-METHODS	Generalized linear models controlled for school fixed effects , individual and family characteristics , and US census block neighborhood effects .
-METHODS	Non-parametric bootstrapping accounted for residual skewness in QALYs and healthcare costs .
-METHODS	Net monetary benefit ( NMB ) was calculated by converting adjusted 5-year QALYs into US$ values and subtracting 5-year healthcare costs .
-METHODS	NMB was then compared across quintiles of adolescent peer status in school at Wave I.
-RESULTS	Results obtained from non-parametric bootstrapping indicate that adolescents with higher peer status in school experience significantly better health and lower healthcare costs over the next 5years .
-RESULTS	At US$ 50,000 per QALY , adolescents with 8 or more friends achieved NMB of US$ 214,300 ( 95 % CI 212,800-215 ,800 ) over a 5-year span , in comparison to adolescents with 0-1 friends , who attained US$ 209,900 ( 95 % CI 207,900-211 ,700 ) NMB .
-RESULTS	This difference translates into approximately US$ 4,440 ( 95 % CI 2,036-6 ,825 ) per socially disengaged adolescent in additional health costs and/or reduced QALYs over 5years .
-CONCLUSIONS	The study calls for randomized controlled trials targeting adolescent peer group structures in schools as a means to promote better health and lower healthcare costs in adulthood .
-
-###25529395
-OBJECTIVE	Prediction of long-term outcomes in patients with community-acquired pneumonia ( CAP ) is incompletely understood .
-OBJECTIVE	We investigated the value of clinical risk scores [ pneumonia severity index ( PSI ) and CURB-65 ] ( Confusion , Urea , Respiratory rate , Blood Pressure , Age > 65years ) and blood biomarkers of different physiopathological pathways in predicting long-term survival in a well-characterized cohort of patients with CAP enrolled in an antibiotic stewardship trial .
-METHODS	Patients admitted with CAP to six medical centres in Switzerland were prospectively followed for 6years .
-METHODS	Cox regression models and area under the receiver operating characteristics curve ( AUC ) were used to investigate associations between initial risk assessment and all-cause mortality .
-METHODS	All-cause mortality during a 6-year follow-up period .
-RESULTS	Six-year mortality in the present cohort ( median age 73years ) was 45.1 % [ 95 % confidence interval ( CI ) 41.8-48 .3 % ] .
-RESULTS	Initial PSI and CURB-65 scores both had excellent long-term prognostic accuracy , with a stepwise increase in mortality per risk class .
-RESULTS	The hazard ratios ( 95 % CI ) of the highest PSI and CURB-65 classes ( reference : lowest class ) were 38.0 ( 14.0-103 .0 ) and 7.8 ( 2.2-14 .5 ) , respectively , after 6years .
-RESULTS	The addition of inflammatory ( pro-adrenomedullin ) and cardiac ( pro-atrial natriuretic peptide ) blood biomarkers measured upon hospital admission further improved the prognostic capabilities of the PSI ( AUC increase from 0.79 to 0.83 ; P < 0.0001 ) and the CURB-65 score ( AUC increase from 0.73 to 0.80 ; P < 0.001 ) .
-CONCLUSIONS	Risk assessment using clinical scores allowed accurate long-term prognostication , which was further improved by the addition of two inflammatory ( pro-adrenomedullin ) and cardiac ( pro-atrial natriuretic peptide ) blood biomarkers .
-CONCLUSIONS	These data provide a rationale for a more risk-adapted , ` personalized ' strategy for long-term management of patients with CAP .
-
-###25872802
-BACKGROUND	Because of limited impact on infant morbidity , mortality , and vitamin A status , the new guideline of the World Health Organization ( WHO ) does not recommend postpartum vitamin A supplementation ( VAS ) as a public health intervention in developing countries .
-BACKGROUND	However , breast milk contains numerous immune-protective components that are important for infant immune development , and several of these components are regulated by vitamin A.
-METHODS	Postpartum women are being enrolled within 3days ( d ) of delivery at a maternity clinic located in a slum area of Dhaka city and randomized to one of four postpartum VAS regimens ( 32/group , total 128 ) .
-METHODS	The regimens are as follows : Group 1 : 200,000 IU VAS at < 3 d and placebo at 6weeks postpartum ; Group 2 : placebo at < 3 d and 200,000 IU VAS at 6weeks postpartum ; Group 3 : 200,000 IU VAS , both at < 3 d and 6weeks postpartum ; Group 4 : placebo , both at < 3 d and 6weeks postpartum .
-METHODS	Breast milk samples at < 3 d ( before supplementation ) and 4months postpartum will be used to measure vitamin A and bioactive compounds .
-METHODS	Infant blood samples at 2 and 4months of age will be used to measure vitamin A , as well as innate and vaccine-specific immune responses .
-METHODS	Dietary , anthropometric , and morbidity data are also being collected .
-CONCLUSIONS	This is the first placebo-controlled randomized clinical trial of postnatal vitamin A supplementation to investigate the key bioactive compounds in breast milk , important for infant immunity , in relation to dose and time point of postpartum supplementation and whether such maternal supplementation improves infant immune status during the critical period of early infancy .
-BACKGROUND	ClinicalTrials.gov : NCT02043223 , 5 December 2013 .
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-###24398758
-OBJECTIVE	To compare the therapeutic effects and adverse reactions of pemetrexed and docetaxel as salvage chemotherapy in patients with nonsmall-cell lung cancer ( NSCLC ) after the failure of epidermal growth factor receptor-tyrosine kinase inhibitors ( EGFR-TKI ) .
-METHODS	In this randomized Phase 2 trial , patients with NSCLC who had previously failed EGFR-TKI therapy were randomized to receive intravenous pemetrexed ( 500mg/m ( 2 ) for 21 days [ one cycle ] ) or docetaxel ( 75mg/m ( 2 ) for 21 days [ one cycle ] ) .
-METHODS	Therapeutic effects were evaluated according to Response Evaluation Criteria in Solid Tumours standards and adverse effects were evaluated according to the US National Cancer Institute Common Terminology Criteria for Adverse Events .
-RESULTS	There was no statistically significant difference in disease control rate , response rate , median survival and 1-year survival between treatment groups .
-RESULTS	Rates of nausea , myelosuppression , renal damage and hair loss were significantly higher in the docetaxel group than the pemetrexed group .
-CONCLUSIONS	Pemetrexed is effective and well tolerated as salvage chemotherapy in patients with NSCLC after EGFR-TKI failure and may be a suitable therapeutic option in these patients .
-
-###25048075
-OBJECTIVE	Long-term physical activity is reported to improve chronic systemic inflammation , which provides protection against the ensuing development of chronic disease .
-OBJECTIVE	Accordingly , the present study assessed changes in pro- and anti-inflammatory cytokines , aerobic capacity and body composition following 8 weeks of either small-sided games ( SSG ) or cycling ( CYC ) training compared to a sedentary control ( CON ) condition .
-METHODS	Thirty-three middle-aged , sedentary men were randomized into CYC ( n = 11 ) , SSG ( n = 11 ) , or CON ( n = 11 ) conditions .
-METHODS	The CYC and SSG conditions trained 3 days/week for 8 weeks , whilst CON maintained habitual activity and dietary patterns .
-METHODS	Pre - and post-intervention testing included a dual-energy X-ray absorptiometry scan , sub-maximal ( 80 % maximal heart rate ) aerobic capacity ( VO ) and fasting venous blood .
-METHODS	Venous blood measures for pro-inflammatory markers included C-reactive protein ( CRP ) , interleukin ( IL ) -6 , IL-1 , tumor necrosis factor - , and leptin ; anti-inflammatory markers included IL-10 , IL-1 receptor agonist , and adiponectin .
-RESULTS	Both CYC and SSG increased submaximal power output and VO ( P < 0.05 ) , decreased total body fat-mass ( TB-FM ; P < 0.05 ) , and CRP ( SSG , -0.45 0.42 mg L ( -1 ) ; P = 0.008 ; CYC , -0.44 0.59 mg L ( -1 ) ; P = 0.02 ) .
-RESULTS	Only SSG increased total body fat-free mass ( TB-FFM ; +1.1 1.2 kg ; P = 0.001 ) and decreased concentration of plasma IL-6 ( -0.69 0.62 pg mL ( -1 ) ; P = 0.002 ) and leptin ( -2,212 2,531 ng mL ( -1 ) ; P = 0.014 ) .
-CONCLUSIONS	Cycling and SSG training were both effective at improving CRP , VO and TB-FM .
-CONCLUSIONS	Furthermore , SSG training has also shown to be an effective training approach in reducing IL-6 and leptin and increasing muscle mass within sedentary , middle-aged men .
-
-###25290608
-OBJECTIVE	To determine whether a cyromazine-resistant strain of Lucilia cuprina was able to establish strikes sooner than a susceptible strain on cyromazine - or dicyclanil-treated sheep .
-METHODS	Groups of 7 sheep were treated with cyromazine or dicyclanil in accordance with label directions .
-METHODS	Beginning 5 weeks after treatment , 5 sheep from each group were challenged by implantation of neonate larvae belonging to the cyromazine-resistant strain ` Nimmitabel-selected ' and the susceptible blowfly strain ` Field 2011 ' according to standard larval implant technique .
-METHODS	The implant sites were alternated between the shoulder , mid-back and rump within the treatment zone .
-METHODS	Similarly , implants of the resistant and susceptible strain larvae were alternated at each challenge such that the strain implanted on the left side of the sheep at one challenge was implanted on the right side at the next .
-METHODS	Challenges were conducted at 3-weekly intervals until the susceptible larvae formed strikes on at least 2 of the 5 sheep in a treatment group or until 29 weeks after treatment .
-RESULTS	Sheep treated with cyromazine or dicyclanil were protected from flystrike by the cyromazine-susceptible strain for periods consistent with , or longer than , the registered product label claims .
-RESULTS	The cyromazine-resistant strain created strikes several weeks sooner after treatment than did the susceptible strain .
-RESULTS	Accordingly , the protection periods provided by cyromazine and dicyclanil against the resistant strain were reduced from 14 and 18-24 weeks to < 8 weeks and < 11 weeks , respectively .
-CONCLUSIONS	Resistance , even in the pure-breeding resistant strain , was not so severe as to cause treatment failure with cyromazine or dicyclanil , but was sufficient to reduce the protection period provided .
-CONCLUSIONS	It is recommended that producers adopt management practices that minimise the development of resistance to these and other compounds .
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-###24343370
-OBJECTIVE	Cardiopulmonary bypass ( CPB ) , utilized in on-pump coronary artery bypass graft procedures ( CABG ) induces generalized immune suppression , release of heat shock proteins ( HSP ) , inflammatory markers and apoptosis-specific proteins .
-OBJECTIVE	We hypothesized that continued mechanical ventilation during cardiopulmonary bypass attenuates immune response and HSP liberation .
-METHODS	Thirty patients undergoing conventional coronary artery bypass graft ( CABG ) operation were randomized into a ventilated on CPB ( VG ; N. = 15 ) and a non-ventilated CPB group ( NVG ; N. = 15 ) .
-METHODS	Blood samples were drawn at the beginning and end of surgery , as well as on the five consecutive postoperative days ( POD ) .
-METHODS	Molecular markers were measured by ELISA .
-METHODS	Data are given as mean ( SD ) .
-METHODS	Mann-Whitney-U-test was used for statistical analysis .
-RESULTS	Serum concentrations of HSP70 were significantly lower in VG compared to NVG on POD-1 ( VG : 1629608 vs. NVG : 52032128.6 pg/mL , P < 0.001 ) .
-RESULTS	HSP27 and HSP60 depicted a minor increase in both study groups at the end of surgery without any intergroup differences ( HSP27 : VG 6207.91252.5 vs. NVG 7424.12632.5 ; HSP60 : VG 1046.2478.8 vs. NVG 1223.5510.1 ) .
-RESULTS	IL-8 and CK-18 M30 evidenced the highest serum concentrations at the end of surgery ( IL-8 : VG 119.577.9 vs. NVG 148.0184.55 ; CK-18 M30 : VG 62.139.2 vs. NVG 67.533.9 ) with no differences between groups .
-RESULTS	Decreased ICAM-1 serum concentrations were detected postoperatively , however ICAM-1 concentrations on POD-1 to POD-5 showed slightly elevated concentrations in both study groups with no intergroup differences .
-CONCLUSIONS	Significantly less HSP70 was detectable in patients receiving uninterrupted mechanical lung ventilation on CPB , indicating either different inflammatory response , cellular stress or cell damage between the ventilated and non-ventilated group .
-CONCLUSIONS	These data suggest that continued mechanical ventilation has a modulatory effect on the immune response in patients after CABG surgery .
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-###24755148
-BACKGROUND	Time in therapeutic range ( TTR ) is a standard quality measure of the use of warfarin .
-BACKGROUND	We assessed the relative effects of rivaroxaban versus warfarin at the level of trial center TTR ( cTTR ) since such analysis preserves randomized comparisons .
-RESULTS	TTR was calculated using the Rosendaal method , without exclusion of international normalized ratio ( INR ) values performed during warfarin initiation .
-RESULTS	Measurements during warfarin interruptions > 7 days were excluded .
-RESULTS	INRs were performed via standardized finger-stick point-of-care devices at least every 4 weeks .
-RESULTS	The primary efficacy endpoint ( stroke or non-central nervous system embolism ) was examined by quartiles of cTTR and by cTTR as a continuous function .
-RESULTS	Centers with the highest cTTRs by quartile had lower-risk patients as reflected by lower CHADS2 scores ( P < 0.0001 ) and a lower prevalence of prior stroke or transient ischemic attack ( P < 0.0001 ) .
-RESULTS	Sites with higher cTTR were predominantly from North America and Western Europe .
-RESULTS	The treatment effect of rivaroxaban versus warfarin on the primary endpoint was consistent across a wide range of cTTRs ( P value for interaction = 0.71 ) .
-RESULTS	The hazard of major and non-major clinically relevant bleeding increased with cTTR ( P for interaction = 0.001 ) , however , the estimated reduction by rivaroxaban compared with warfarin in the hazard of intracranial hemorrhage was preserved across a wide range of threshold cTTR values .
-CONCLUSIONS	The treatment effect of rivaroxaban compared with warfarin for the prevention of stroke and systemic embolism is consistent regardless of cTTR .
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-###24703319
-BACKGROUND	The prognostic utility of vascular endothelial growth factor A ( VEGF-A ) splice variants in patients with advanced breast cancer treated with bevacizumab has not been studied .
-METHODS	A total of 111 patients with metastatic breast cancer treated with weekly docetaxel or ixabepilone without bevacizumab ( cohort A ) and 100 treated with weekly paclitaxel and bevacizumab ( cohort B ) were studied .
-METHODS	Formalin-fixed tumors were macrodissected for reverse transcription quantitative polymerase chain reaction relative quantification of VEGF-A165 , -189 , and -206 isoforms spliced at exon 8 proximal splice site ( VEGF-Axxxa ) and at exon 8 distal splice site ( VEGF-Axxxb ) .
-RESULTS	For high VEGF-Axxxa , the hazard ratios ( HRs ) for progression were 1.08 ( P = .71 ) in non-bevacizumab-treated patients ( cohort A ) and 0.66 ( P = .22 ) in bevacizumab-treated patients ( cohort B ) , and the HRs for death were 1.45 ( P = .13 ) and 0.50 ( P = .049 ) , respectively .
-RESULTS	The interaction of VEGF-Axxxa with bevacizumab administration was significant ( P = .011 ) for overall survival ( OS ) .
-RESULTS	High tissue VEGF-Axxxb was not prognostic in cohort A but was predictive for bevacizumab benefit in cohort B ( HR for progression , 0.57 [ P = .04 ] ; HR for death , 0.51 [ P = .02 ] ) .
-RESULTS	Exploratory analyses done only in cohort B suggested that abundance of VEGFR1 messenger RNA ( mRNA ) in peripheral blood and low VEGFR2 mRNA in tissue correlated with poor outcome .
-RESULTS	In multivariate analysis , high tissue mRNA of angiogenic VEGF-Axxxa in the presence of bevacizumab therapy predicted for favorable progression-free survival ( HR for progression , 0.39 ; P = .0227 ) and OS ( HR for death , 0.32 ; P = .0140 ) .
-CONCLUSIONS	Tissue mRNA expression of angiogenic VEGF-Axxxa isoforms was retrospectively associated with adverse prognosis in the absence of bevacizumab and with favorable outcome when bevacizumab was administered in patients with advanced breast cancer .
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-###24753534
-OBJECTIVE	Although anxiety is common in children with attention-deficit/hyperactivity disorder ( ADHD ) , it is unclear how anxiety influences the lives of these children .
-OBJECTIVE	This study examined the association between anxiety comorbidities and functioning by comparing children with ADHD and no , 1 , or 2 anxiety comorbidities .
-OBJECTIVE	Differential associations were examined by current ADHD presentation ( subtype ) .
-METHODS	Children with diagnostically confirmed ADHD ( N = 392 ; 5-13 years ) were recruited via 21 pediatrician practices across Victoria , Australia .
-METHODS	Anxiety was assessed by using the Anxiety Disorders Interview Schedule for Children-IV .
-METHODS	Functional measures included parent-reported : quality of life ( QoL ; Pediatric Quality of Life Inventory 4.0 ) , behavior and peer problems ( Strengths and Difficulties Questionnaire ) , daily functioning ( Daily Parent Rating of Evening and Morning Behavior ) , and school attendance .
-METHODS	Teacher-reported behavior and peer problems ( Strengths and Difficulties Questionnaire ) were also examined .
-METHODS	Linear and logistic regression controlled for ADHD severity , medication use , comorbidities , and demographic factors .
-RESULTS	Children with 2 anxiety comorbidities ( n = 143 ; 39 % ) had poorer QoL ( effect size : -0.8 ) and more difficulties with behavior ( effect size : 0.4 ) and daily functioning ( effect size : 0.3 ) than children without anxiety ( n = 132 ; 36 % ) .
-RESULTS	Poorer functioning was not observed for children with 1 anxiety comorbidity ( n = 95 ; 26 % ) .
-RESULTS	Two or more anxiety comorbidities were associated with poorer functioning for children with both ADHD-Inattentive and ADHD-Combined presentation .
-CONCLUSIONS	Children with ADHD demonstrate poorer QoL , daily functioning and behavior when 2 anxiety comorbidities are present .
-CONCLUSIONS	Future research should examine whether treating anxiety in children with ADHD improves functional outcomes .
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-###24857044
-BACKGROUND	The role of human equilibrative nucleoside transporter 1 ( hENT1 ) as a predictive biomarker for gemcitabine efficacy in advanced pancreatic cancer remains unclear to date .
-METHODS	AIO-PK0104 was a German multicenter phase III trial comparing gemcitabine/erlotinib followed by capecitabine ( GEC ) with capecitabine/erlotinib followed by gemcitabine ( CEG ) in advanced pancreatic cancer .
-METHODS	Archival tumour tissue from 169 of the 274 eligible study patients was available for a central and standardised immunohistochemistry staining for hENT1 expression using the SP120 rabbit monoclonal anti-hENT1 antibody .
-METHODS	Within a retrospective translational subgroup analysis , biomarker data were correlated with efficacy end-points .
-RESULTS	Thirty-nine out of 130 fresh-cut slides were scored as hENT1 ( high ) ( 30 % ) , whereas 91 samples were classified as hENT1 ( low ) ( 70 % ) .
-RESULTS	For the 62 patients randomised to CEG median overall survival was estimated with 6.4 months in the hENT1 ( low ) compared to 6.9 months in the hENT1 ( high ) subgroup ( Hazard Ratio ( HR ) 0.88 , 95 % confidence interval ( CI ) 0.48-1 .61 , p = 0.67 ) .
-RESULTS	For the 68 patients randomised to GEC survival was 5.7 months in the hENT1 ( low ) compared to 4.4 months in the hENT1 ( high ) subgroup ( HR 1.16 , 95 % CI 0.69-1 .96 , p = 0.57 ) .
-RESULTS	In 101 patients receiving gemcitabine at any time during study treatment ( either within the 1st - or 2nd-line setting ) hENT1 ( low ) cases had a median overall survival of 7.5 months and hENT1 ( high ) patients an overall survival of 4.4 months ( HR 1.30 , 95 % CI 0.84-2 .03 , p = 0.24 ) , respectively .
-CONCLUSIONS	Within this subgroup analysis from Arbeitsgemeinschaft Internistische Onkologie-pancreatic cancer ( AIO-PK0104 ) , no evidence supporting the use of hENT1 as a predictive biomarker for gemcitabine efficacy in patients with advanced pancreatic cancer was found .
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-###24268371
-OBJECTIVE	This study aimed to compare the efficacy and safety of bismuth-included standard regimen and modified sequential treatments in Turkey , where the success rate of standard triple therapy is very low .
-METHODS	One-hundred and sixty patients with dyspeptic complaints and nave Helicobacter pylori infection were randomized into four groups : 41 patients received standard 14-day quadruple treatment ( STD ) ( Rabeprazole 20mg-bid , bismuth subcitrate ( 120 mg-qid ) , Tetracycline 500 mg-qid , Metronidazole 500 mg-tid ) for 2 weeks .
-METHODS	The modified sequential therapy groups received 20 mg rabeprazole and 1g amoxicillin , twice daily for the first 5 days , followed by Rabeprazole 20mg-bid , bismuth subcitrate ( 120 mg-qid ) , Tetracycline 500 mg-qid , Metronidazole 500 mg-tid for the remaining 5 ( 10 day sequential therapy group-10S ) ( 42 patients ) , 7 ( 12 day sequential therapy group-12S ) ( 42 patients ) and 9 ( 14 day sequential therapy group-14S ) ( 41 patients ) days .
-RESULTS	The overall compliance and H. pylori eradication rate among the 160 patients who completed the H. pylori eradication regimens were 86.9 % ( 139/160 ) and 78.1 % ( 125/160 ) , respectively .
-RESULTS	The results were not statistically different between groups in the eradication rates .
-RESULTS	Per-protocol eradication rates were 76.5 % in STD , 71.4 % in 10S , 82.4 % in 12S and 83.3 % in 14S groups ( p = 0.7 ) .
-RESULTS	Intention-to-treatment rates were 77.5 % in STD , 72.5 % in 10S , 82.5 % in 12S and 80.0 % in 14S groups ( p = 0.5 ) .
-CONCLUSIONS	The eradication rates of standard 14-day and different sequential quadruple treatment regimens are comparable and much more higher than with standard 14-day triple H. pylori eradication treatment that has been reported previously in Turkey .
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-###24713632
-BACKGROUND	Restrictive , very low-energy diets focused on rapid weight loss have proven to be effective in improving asthma outcome in obese patients , but their use in children and pubescents is controversial due its potential consequences in growth .
-BACKGROUND	More conservative , normocaloric schemes are suggested as a more suitable dietary approach for these patients .
-METHODS	A randomized clinical trial was run of 51 pubertal adolescents with asthma and obesity , who were allocated to either an interventional 28-week program of normocaloric diet based on normal requirements for height and meal planning ( n = 26 ) or a non-interventional ( free diet ) control group ( n = 25 ) .
-METHODS	Asthma-related quality of life ( AR-QOL , assessed by the Standardized Pediatric Asthma Quality of Life Questionnaire , PAQLQ [ S ] ) and clinical indicators of asthma control were measured before and after the intervention period .
-RESULTS	Diet intervention was associated with a significant improvement in AR-QOL in relation to baseline ( PAQLQ [ S ] scores ) compared with controls , both in overall score ( p < 0.001 ) and its subdomains ( activity limitation , p < 0.001 ; symptoms , p < 0.002 ; emotional function , p < 0.001 ) .
-RESULTS	The group with normocaloric diet observed a significant decrease in body mass index z-score , which correlated positively with the improvement in AR-QOL ( Spearman 's r = 0.51 , p < 0.01 ) , in addition to have significantly fewer events of acute attacks of asthma and nighttime awakenings , plus a non-significant reduction in the use of inhaled corticosteroids .
-RESULTS	No significant changes were observed in the pulmonary function tests .
-CONCLUSIONS	The normocaloric dietary intervention was associated with improvement of AR-QOL and some aspects of asthma control .
-CONCLUSIONS	Such structured dietary programs could probably have a role as a complementary non-pharmacological therapeutic strategy in obese pubertal adolescents with asthma .
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-###24228747
-BACKGROUND	Because of symptoms , people with lumbar spinal stenosis ( LSS ) are often inactive , and this sedentary behaviour implies risk for diseases including obesity .
-BACKGROUND	Research has identified body mass index as the most powerful predictor of function in LSS .
-BACKGROUND	This suggests that function may be improved by targeting weight as a modifiable factor .
-BACKGROUND	An e-health lifestyle intervention was developed aimed at reducing fat mass and increasing physical activity in people with LSS .
-BACKGROUND	The main components of this intervention include pedometer-based physical activity promotion and nutrition education .
-METHODS	The Spinal Stenosis Pedometer and Nutrition Lifestyle INTERVENTION ( SSPANLI ) was developed and piloted with 10 individuals .
-METHODS	The protocol for a randomized controlled trail comparing the SSPANLI intervention to usual non-surgical care follows .
-METHODS	One hundred six ( 106 ) overweight or obese individuals with LSS will be recruited .
-METHODS	Baseline and follow-up testing includes dual energy x-ray absorptiometry , blood draw , 3-day food record , 7-day accelerometry , questionnaire , maximal oxygen consumption , neurological exam , balance testing and a Self-Paced Walking Test .
-METHODS	During Week 1 , the intervention group will receive a pedometer , and a personalized consultation with both a Dietitian and an exercise specialist .
-METHODS	For 12 weeks participants will log on to the e-health website to access personal step goals , walking maps , nutrition videos , and motivational quotes .
-METHODS	Participants will also have access to in-person Coffee Talk meetings every 3 weeks , and meet with the Dietitian and exercise specialist at week 6 .
-METHODS	The control group will proceed with usual care for the 12-week period .
-METHODS	Follow-up testing will occur at Weeks 13 and 24 .
-CONCLUSIONS	This lifestyle intervention has the potential to provide a unique , non-surgical management option for people with LSS .
-CONCLUSIONS	Through decreased fat mass and increased function , we may reduce risk for obesity , chronic diseases of inactivity , and pain .
-CONCLUSIONS	The use of e-health interventions provides an opportunity for patients to become more involved in managing their own health .
-CONCLUSIONS	Behaviour changes including increased physical activity , and improved dietary habits promote overall health and quality of life , and may decrease future health care needs in this population .
-BACKGROUND	Clinicaltrials.gov , NCT01902979 .
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-###24303967
-BACKGROUND	In this study we hypothesized that signs of atypical atrial activation would be associated with cardiac resynchronization therapy ( CRT ) response in patients with mildly symptomatic heart failure ( CHF ) , left ventricular dysfunction , and wide QRS complex .
-METHODS	Patients included in the CRT-D arm in MADIT-CRT were studied ( n = 892 ) .
-METHODS	Unfiltered signal-averaged P waves were analyzed to determine orthogonal P-wave morphology ( typical morphologies were predefined as having positive signals in Leads X and Y and a negative or negative-positive signal in Lead Z. All other patterns were classified as atypical ) .
-METHODS	The association between P-wave morphology and data on echocardiographic response at 1 year was analyzed .
-RESULTS	Atypical P-wave morphology was found in 21 % ( n = 186 ) of the patients at baseline .
-RESULTS	Patients with atypical P-wave morphology were more often female ( 31 % vs. 24 % , P = 0.025 ) , had lower BMI ( 28 5 kg/m ( 2 ) vs. 29 5 kg/m ( 2 ) , P = 0.008 ) , had more ischemic CHF ( 60 % vs. 52 % , P = 0.026 ) and had smaller left atrial volumes ( 90 20 mL vs. 94 22 mL , P = 0.034 ) .
-RESULTS	Atypical P-wave morphology at baseline was associated with superior response to CRT at 1 year with a larger reduction in left ventricular end-diastolic volume ( -23 12 % vs. -20 11 % , P = 0.009 ) , left ventricular end-systolic volume ( -36 16 % vs. -31 16 % , P = 0.006 ) , and left atrial volume ( -31 12 % vs. -27 12 % , P = 0.005 ) , with a slightly larger absolute increase in left ventricular ejection fraction ( LVEF ) ( 12 5 % vs. 11 5 % , P = 0.009 ) .
-RESULTS	These associations were found to be independent of traditional predictors .
-CONCLUSIONS	The presence of atypical P-wave morphology recorded is independently associated with a favorable echocardiographic cardiac remodeling response to CRT .
-
-###26467136
-BACKGROUND	Classical laparoscopic cholecystectomy involves four ports while most novel ` single port ' technique only requires one incision on the abdominal wall .
-BACKGROUND	This technique is thought to decrease surgical trauma and improve cosmesis although there are reports pointing out that classical laparoscopic cholecystectomy is also feasible in terms of cosmesis .
-OBJECTIVE	In this study we tried to determine if there are certain advantages in quality of life after single port surgery which would justify its utilization instead of classical laparoscopic cholecystectomy .
-METHODS	This is aprospective randomized study which enrolled 30 patients randomized either into classical laparoscopic cholecystectomy or single port surgery .
-METHODS	The primary endpoint was patient satisfaction after surgery .
-METHODS	This was assessed with short form 36 and gastrointestinal quality of life index ( first preoperatively and then 3months postoperatively ) and avisual analogue scale on the first and seventh days .
-RESULTS	There was not astatistically significant difference between groups in the emotional role , social functions , mental health , vitality and general health subscales of short form 36 .
-RESULTS	At the end of 12 weeks , both groups demonstrated increases in the gastrointestinal and social subscales of the gastrointestinal quality of life index .
-RESULTS	There was not astatistically significant difference between groups when the visual analogue scale scores on first and seventh days were compared .
-CONCLUSIONS	The equal length of hospitalization , patient quality of life and pain perception and the longer operative times , high likelihood of incisional hernia and surgical site infection call into question the utilization of single port surgery , as it does not seem to confer an advantage over classical laparoscopic cholecystectomy .
-
-###25468387
-BACKGROUND	Iron deficiency anemia and serum phosphate levels > 4.0 mg/dL are relatively common in chronic kidney disease stages 3 to 5 and are associated with higher risks of progressive loss of kidney function , cardiovascular events , and mortality .
-METHODS	Double-blind , placebo-controlled , randomized trial .
-METHODS	149 patients with estimated glomerular filtration rates < 60 mL/min/1 .73 m ( 2 ) , iron deficiency anemia ( hemoglobin , 9.0-12 .0 g/dL ; transferrin saturation [ TSAT ] 30 % , serum ferritin 300 ng/mL ) , and serum phosphate levels 4.0 to 6.0 mg/dL .
-METHODS	Use of intravenous iron or erythropoiesis-stimulating agents was prohibited .
-METHODS	Randomization to treatment for 12 weeks with ferric citrate coordination complex ( ferric citrate ) or placebo .
-METHODS	Coprimary end points were change in TSAT and serum phosphate level from baseline to end of study .
-METHODS	Secondary outcomes included change from baseline to end of treatment in values for ferritin , hemoglobin , intact fibroblast growth factor 23 ( FGF-23 ) , urinary phosphate excretion , and estimated glomerular filtration rate .
-RESULTS	Ferric citrate treatment increased mean TSAT from 22 % 7 % ( SD ) to 32 % 14 % and reduced serum phosphate levels from 4.5 0.6 to 3.9 0.6 mg/dL , while placebo exerted no effect on TSAT ( 21 % 8 % to 20 % 8 % ) and less effect on serum phosphate level ( 4.7 0.6 to 4.4 0.8 mg/dL ; between-group P < 0.001 for each ) .
-RESULTS	Ferric citrate increased hemoglobin levels ( from 10.5 0.8 to 11.0 1.0 g/dL ; P < 0.001 vs placebo ) , reduced urinary phosphate excretion 39 % ( P < 0.001 vs placebo ) , and reduced serum intact FGF-23 levels from a median of 159 ( IQR , 102-289 ) to 105 ( IQR , 65-187 ) pg/mL ( P = 0.02 vs placebo ) .
-RESULTS	The incidence and severity of adverse effects were similar between treatment arms .
-CONCLUSIONS	The study is limited by relatively small sample size and short duration and by having biochemical rather than clinical outcomes .
-CONCLUSIONS	Short-term use of ferric citrate repletes iron stores , increases hemoglobin levels , and reduces levels of serum phosphate , urinary phosphate excretion , and FGF-23 in patients with chronic kidney disease stages 3 to 5 .
-
-###25499302
-OBJECTIVE	The aim of this analysis was to assess the 7-year long-term safety and effectiveness of a randomized comparison of percutaneous coronary intervention ( PCI ) with sirolimus-eluting stents ( SES ) versus minimally invasive direct coronary artery bypass ( MIDCAB ) surgery for the treatment of isolated proximal left anterior descending lesions .
-BACKGROUND	Long-term follow-up data comparing PCI by SES and MIDCAB surgery for isolated proximal left anterior descending lesions are sparse .
-METHODS	Patients were randomized either to PCI with SES ( n = 65 ) or MIDCAB ( n = 65 ) .
-METHODS	Follow-up data were obtained after 7 years with respect to the primary composite endpoint of death , myocardial infarction , and target vessel revascularization .
-METHODS	Angina was assessed by the Canadian Cardiovascular Society classification and quality of life with Short Form 36 and MacNew quality of life questionnaires .
-RESULTS	Follow-up was conducted in 129 patients at a median time of 7.3 years ( interquartile range : 5.7 , 8.3 ) .
-RESULTS	There were no significant differences in the incidence of the primary composite endpoint between groups ( 22 % PCI vs. 12 % MIDCAB ; p = 0.17 ) or the endpoints death ( 14 % vs. 17 % ; p = 0.81 ) and myocardial infarction ( 6 % vs. 9 % , p = 0.74 ) .
-RESULTS	However , the target vessel revascularization rate was higher in the PCI group ( 20 % vs. 1.5 % ; p < 0.001 ) .
-RESULTS	Clinical symptoms and quality of life improved significantly from baseline with both interventions and were similar in magnitude between groups .
-CONCLUSIONS	At 7-year follow-up , PCI by SES and MIDCAB in isolated proximal left anterior descending lesions yielded similar long-term outcomes regarding the primary composite clinical endpoint and quality of life .
-CONCLUSIONS	Target vessel revascularization was more frequent in the PCI group .
-CONCLUSIONS	( MIDCAB Versus DES in Proximal LAD Lesions ; NCT00299429 ) .
-
-###25193431
-OBJECTIVE	This 2-arm , phase 1 , crossover study compared the relative bioavailability of two dovitinib ( TKI258 ) capsule formulations [ anhydrate clinical service form ( CSF ) and monohydrate final market image ( FMI ) ; Arm 1 ] and determined the effect of food on dovitinib exposure ( Arm 2 ) .
-METHODS	Patients with advanced solid tumors were enrolled in one of the 2 arms .
-METHODS	Arm 1 randomized patients to a single 500-mg dose of either CSF or FMI followed by 7 days of rest and 500 mg of the other formulation .
-METHODS	Arm 2 patients received 300 mg of FMI once daily and were randomized to follow one of six meal sequences , each with three prandial conditions : low fat ( LF ) , high fat ( HF ) , or no meal ( NM ) .
-RESULTS	Twenty-three and 37 patients were enrolled and 19 and 21 were evaluable in Arms 1 and 2 , respectively .
-RESULTS	In Arm 1 , the adjusted geometric means for FMI had small reductions relative to CSF [ area under the plasma concentration-time curve ( AUClast ) decreased by 12 % , maximum concentration ( C max ) decreased by 3 % ] .
-RESULTS	In Arm 2 , the HF meal versus NM showed a 2 % increase in the adjusted geometric mean for AUClast and a 5 % decrease for C max .
-RESULTS	The LF meal versus NM comparison showed 9 and 6 % increases for AUClast and C max , respectively .
-RESULTS	Overall , common adverse events included nausea , vomiting , diarrhea , and fatigue .
-CONCLUSIONS	Systemic exposure to dovitinib was similar for the FMI and CSF capsule formulations .
-CONCLUSIONS	Additionally , since prandial conditions did not affect the systemic exposure , dovitinib can be taken with or without food .
-
-###25163819
-OBJECTIVE	To determine whether 17 alpha-hydroxyprogesterone caproate ( 17OHPC ) prolongs gestation beyond 37 weeks of gestation ( primary outcome ) and reduces neonatal morbidity ( secondary outcome ) in twin pregnancy .
-METHODS	Randomised controlled double-blind clinical trial .
-METHODS	Tertiary-care university medical centre .
-METHODS	Unselected women with twin pregnancies .
-METHODS	Participants received weekly injections of 250 mg 17OHPC ( n = 194 ) or placebo ( n = 94 ) , from 16-20 to 36 weeks of gestation .
-METHODS	Randomisation was performed using the permuted-block randomisation method .
-METHODS	Data were analysed on an intention-to-treat basis .
-METHODS	Preterm birth ( PTB ) rate before 37 weeks of gestation .
-RESULTS	There were no significant differences in the average gestational age at delivery , or in the rates of PTB before 37 , 32 , and 28 weeks of gestation , between the two groups .
-RESULTS	The proportion of very-low-birthweight neonates ( < 1500 g ) was significantly lower in the 17OHPC group ( 7.6 % ) compared with placebo ( 14.3 % ) ( relative risk , RR 0.5 ; 95 % confidence interval , 95 % CI 0.3-0 .9 ; P = 0.01 ) .
-RESULTS	Progestogen-treated neonates had a significantly lower composite neonatal morbidity ( 19.1 % ) compared with placebo ( 30.9 % ) ( odds ratio , OR 0.53 ; 95 % CI 0.31-0 .90 ; P = 0.02 ) , with significantly lower odds for respiratory distress syndrome ( 14.4 versus 23.4 % ; OR 0.55 ; 95 % CI 0.31-0 .98 ; P = 0.04 ) , retinopathy of prematurity ( 1.1 versus 4.6 % ; OR 0.21 ; 95 % CI 0.05-0 .96 ; P = 0.04 ) , and culture-confirmed sepsis ( 3.4 versus 12.8 % ; OR 0.24 ; 95 % CI 0.10-0 .57 ; P = 0.00 ) .
-CONCLUSIONS	Intramuscular 17OHPC therapy did not reduce PTB before 37 weeks of gestation in unselected twin pregnancies .
-CONCLUSIONS	Nonetheless , 17OHPC significantly reduced neonatal morbidity parameters and increased birthweight .
-
-###24612148
-OBJECTIVE	To assess treatment satisfaction with tadalafil or tamsulosin vs placebo in a 12-week , randomised , double-blind study of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( LUTS/BPH ) .
-METHODS	After a 4-week placebo lead-in period , men aged 45 years with an International Prostate Symptom Score ( IPSS ) of 13 and a maximum urinary flow rate of 4 to 15mL/s received placebo ( 172 men ) , tadalafil 5mg ( 171 ) , or tamsulosin 0.4 mg ( 168 ) once daily for 12 weeks .
-METHODS	Treatment Satisfaction Scale-BPH ( TSS-BPH ) responses were assessed based on median treatment differences using the van Elteren test .
-RESULTS	Overall treatment satisfaction was greater for tadalafil vs placebo ( P = 0.005 ) , based on greater satisfaction with efficacy ( P = 0.003 ) ; neither overall treatment satisfaction nor satisfaction with efficacy was greater for tamsulosin vs placebo ( P 0.409 ) .
-RESULTS	For individual questions , 66.5 % of men rated tadalafil treatment as ` effective/very effective ' ( Question 1 , Q1 ) vs placebo ( P = 0.011 ) , 72.6 % would ` definitely/probably recommend their treatment ' ( Q3 ; P = 0.043 ) , 71.8 % were generally ` very satisfied/satisfied with their medication ' ( Q8 ; P < 0.003 ) , and 65.0 % would ` definitely/probably continue therapy ' ( Q10 ; P = 0.035 ) .
-RESULTS	With tamsulosin , differences vs placebo were not statistically significant .
-RESULTS	Subgroup analyses of overall TSS-BPH by baseline age ( 65 / > 65 years ) , history of erectile dysfunction ( yes/no ) , LUTS/BPH severity ( IPSS < / 20 ) , total testosterone level ( < 300/300ng/dL ) , and age-specific predicted prostate volume ( < 40/40mL ) showed no statistically significant treatment-subgroup interactions .
-RESULTS	Men with recent prior - blocker therapy reported greater treatment satisfaction with tadalafil vs placebo , with only borderline difference for men without prior therapy .
-CONCLUSIONS	Treatment satisfaction was greater with tadalafil vs placebo , with no significant difference between tamsulosin and placebo .
-
-###25322754
-BACKGROUND	The potential negative influence of angiogenic gene therapy on the development or progression of retinal pathologies such as diabetic retinopathy ( DR ) or age-related macular degeneration ( AMD ) has led to the systematic exclusion of affected patients from trials .
-BACKGROUND	We investigated the role of nonviral fibroblast factor 1 ( NV1FGF ) in two phase II , multinational , double-blind , randomized , placebo-controlled , gene therapy trials ( TALISMAN 201 and 211 ) .
-METHODS	One hundred and fifty-two subjects with critical limb ischemia or claudication were randomized to receive eight intramuscular injections of 2.5 ml of NV1FGF at 0.2 mg/ml or 0.4 mg/dl or placebo .
-METHODS	One hundred and fifty-two patients received a plasmid dose of NV1FGF of up to 32 mg or placebo .
-METHODS	All patients underwent a systematic ophthalmologic examination at baseline and at 3 , 6 or 12 months following gene therapy .
-METHODS	Twenty-six of these patients ( Mnster subgroup ) received a retinal fluorescence angiography at baseline and at final examination .
-RESULTS	Among those 26 patients , four of nine patients with diabetes suffered from nonproliferative DR. Three patients showed non-exsudative AMD .
-RESULTS	No change of retinal morphology or function was observed in Mnster subgroup of both TALISMAN trials independent of the intramuscular NV1FGF dosage applied .
-CONCLUSIONS	Angiogenic gene therapy using NV1FGF is safe even in diabetics .
-
-###24311384
-OBJECTIVE	We used the Western Denmark Heart Registry to assess one-year and long-term all-cause mortality and stent failure following Percutaneous Coronary Intervention ( PCI ) with drug-eluting stents ( DES ) or bare-metal stents ( BMS ) .
-BACKGROUND	The use of DES compared with BMS during PCI has reduced the risk of restenosis in native coronary artery lesions .
-BACKGROUND	In saphenous vein grafts ( SVG ) the outcome after DES compared with BMS is insufficiently described .
-METHODS	From January 1 , 2002 to December 31 , 2010 all patients with PCI of SVG lesions were identified among 3.0 million inhabitants .
-METHODS	Stent failure was defined as clinically driven target lesion revascularization , graft occlusion without intervention , or stent thrombosis .
-RESULTS	The study cohort consisted of 529 patients with 755 SVG lesions ( 348 DES patients with 510 lesions and 181 BMS patients with 245 lesions ) .
-RESULTS	Mean age did not differ between patients with DES-treated lesions compared to patients with BMS-treated lesions ( 67.5 9.1 years vs. 67.6 9.3 years ; P = 0.85 ) .
-RESULTS	The median follow-up time was 3.0 years ( 25th-75th percentile : 1.4-5 .1 years ) .
-RESULTS	One-year ( n = 27 ( 8.2 % ) vs. n = 12 ( 6.7 % ) , log rank P = 0.60 ) and 3-year cumulative mortality ( n = 31 ( 18.8 % ) vs. n = 59 ( 21.8 % ) , log rank P = 0.64 ) did not differ significantly between DES - and BMS-treated patients .
-RESULTS	One-year cumulative stent failure was seen in 39 ( 6.6 % ) DES-treated lesions vs. 24 ( 10.8 % ) BMS-treated lesions ( P = 0.088 ) , and 3-year cumulative stent failure in 48 ( 15.4 % ) vs. 34 ( 18.8 % ) lesions ( P = 0.25 ) , respectively .
-CONCLUSIONS	In SVG lesions , DES showed no long-term benefit compared to BMS in rates of all-cause mortality or stent failure .
-
-###25312998
-BACKGROUND	Implementing optimal lung cancer screening programs requires knowledge of the natural history and detectability of lung cancer .
-BACKGROUND	This information can be derived from the results of clinical trials with the aid of microsimulation models .
-METHODS	Data from the Surveillance , Epidemiology , and End Results ( SEER ) program and individual-level data from the National Lung Screening Trial ( NLST ) and the Prostate , Lung , Colon , and Ovarian Cancer Screening trial ( PLCO ) were used to investigate the sensitivity ( by histology and stage ) of CT and chest radiography ( CXR ) and the mean preclinical sojourn time ( MPST ) of lung cancer ( by gender , histology , and stage ) .
-METHODS	The MISCAN-Lung model was used to reproduce the lung cancer incidence by method of detection ( clinically or screen-detected ) , gender , histology , and stage in both trials and SEER , by calibrating CT and CXR sensitivity and natural history parameters .
-RESULTS	CT sensitivity ranges from 8.83 % to 99.35 % and CXR sensitivity from 2.51 % to 97.31 % , depending on histology and stage .
-RESULTS	CT sensitivity for stage IA is more than 3-fold higher compared with CXR , for all histologies .
-RESULTS	The total MPST estimates for lung cancer progressing through preclinical stages IA to IV range from 3.09 to 5.32 years for men and 3.35 to 6.01 years for women .
-RESULTS	The largest difference in total MPST between genders was estimated for adenocarcinoma .
-CONCLUSIONS	We estimate longer MPSTs for lung cancer compared with previous research , suggesting a greater window of opportunity for lung cancer screening .
-CONCLUSIONS	This study provides detailed insights into the natural history of lung cancer and CT screening effectiveness .
-
-###25629741
-BACKGROUND	Ruxolitinib , a Janus kinase ( JAK ) 1 and 2 inhibitor , was shown to have a clinical benefit in patients with polycythemia vera in a phase 2 study .
-BACKGROUND	We conducted a phase 3 open-label study to evaluate the efficacy and safety of ruxolitinib versus standard therapy in patients with polycythemia vera who had an inadequate response to or had unacceptable side effects from hydroxyurea .
-METHODS	We randomly assigned phlebotomy-dependent patients with splenomegaly , in a 1:1 ratio , to receive ruxolitinib ( 110 patients ) or standard therapy ( 112 patients ) .
-METHODS	The primary end point was both hematocrit control through week 32 and at least a 35 % reduction in spleen volume at week 32 , as assessed by means of imaging .
-RESULTS	The primary end point was achieved in 21 % of the patients in the ruxolitinib group versus 1 % of those in the standard-therapy group ( P < 0.001 ) .
-RESULTS	Hematocrit control was achieved in 60 % of patients receiving ruxolitinib and 20 % of those receiving standard therapy ; 38 % and 1 % of patients in the two groups , respectively , had at least a 35 % reduction in spleen volume .
-RESULTS	A complete hematologic remission was achieved in 24 % of patients in the ruxolitinib group and 9 % of those in the standard-therapy group ( P = 0.003 ) ; 49 % versus 5 % had at least a 50 % reduction in the total symptom score at week 32 .
-RESULTS	In the ruxolitinib group , grade 3 or 4 anemia occurred in 2 % of patients , and grade 3 or 4 thrombocytopenia occurred in 5 % ; the corresponding percentages in the standard-therapy group were 0 % and 4 % .
-RESULTS	Herpes zoster infection was reported in 6 % of patients in the ruxolitinib group and 0 % of those in the standard-therapy group ( grade 1 or 2 in all cases ) .
-RESULTS	Thromboembolic events occurred in one patient receiving ruxolitinib and in six patients receiving standard therapy .
-CONCLUSIONS	In patients who had an inadequate response to or had unacceptable side effects from hydroxyurea , ruxolitinib was superior to standard therapy in controlling the hematocrit , reducing the spleen volume , and improving symptoms associated with polycythemia vera .
-CONCLUSIONS	( Funded by Incyte and others ; RESPONSE ClinicalTrials.gov number , NCT01243944 . )
-
-###24324379
-BACKGROUND	This pilot study investigated the efficacy of a novel virtual reality-cognitive rehabilitation ( VR-CR ) intervention to improve contextual processing of objects in children with autism .
-BACKGROUND	Previous research supports that children with autism show deficits in contextual processing , as well as deficits in its elementary components : abstraction and cognitive flexibility .
-METHODS	Four children with autism participated in a multiple-baseline , single-subject study .
-METHODS	The children were taught how to see objects in context by reinforcing attention to pivotal contextual information .
-RESULTS	All children demonstrated statistically significant improvements in contextual processing and cognitive flexibility .
-RESULTS	Mixed results were found on the control test and changes in context-related behaviours .
-CONCLUSIONS	Larger-scale studies are warranted to determine the effectiveness and usability in comprehensive educational programs .
-
-###25921382
-BACKGROUND	During the ACCORD 12 randomized trial , an evaluation of the clinical tumor response was prospectively performed after neoadjuvant chemoradiotherapy .
-BACKGROUND	The correlations between clinical complete response and patient characteristics and treatment outcomes are reported .
-METHODS	Between 2005 and 2008 the Accord 12 trial accrued 598 patients with locally advanced rectal cancer and compared two different neoadjuvant chemoradiotherapies ( Capox 50 : capecitabine + oxaliplatin +50 Gy vs Cap 45 : capecitabine +45 Gy ) .
-METHODS	An evaluation of the clinical tumor response with rectoscopy and digital rectal examination was planned before surgery .
-METHODS	A score to classify tumor response was used adapted from the RECIST definition : complete response : no visible or palpable tumor ; partial response , stable and progressive disease .
-RESULTS	The clinical tumor response was evaluable in 201 patients .
-RESULTS	Score was : complete response : 8 % ( 16 patients ) ; partial response : 68 % ( 137 patients ) ; stable : 21 % ; progression : 3 % .
-RESULTS	There was a trend toward more complete response in the Capox 50 group ( 9.3 % vs 6.7 % with Cap 45 ) .
-RESULTS	In the whole cohort of 201 pts complete response was significantly more frequent in T2 tumors ( 28 % ; p = 0.025 ) ; tumors < 4cm in diameter ( 14 % ; p = 0.017 ) , less than half rectal circumference and with a normal CEA level .
-RESULTS	Clinical complete response observed in 16 patients was associated with more conservative treatment ( p = 0.008 ) : 2 patients required an abdomino-perineal resection , 11 an anterior resection and 3 patients benefited from organ preservation ( 2 local excision , 1 `` watch and wait '' .
-RESULTS	A complete response was associated with more ypT0 ( 73 % ; p < 0.001 ) ; ypNO ( 92 % ) ; R0 circumferential margin ( 100 % ) .
-CONCLUSIONS	These data support the hypothesis that a clinical complete response assessed using rectoscopy and digital rectal examination after neoadjuvant therapy may increase the chance of a sphincter or organ preservation in selected rectal cancers .
-
-###24451151
-BACKGROUND	New direct-acting antiviral agents are currently being developed to treat chronic HCV .
-BACKGROUND	The efficacy and safety of daclatasvir combined with peginterferon alfa-2a ( alfa-2a ) and ribavirin were assessed in a randomized , double-blind Phase IIa study of Japanese patients with chronic HCV genotype-1 infection .
-METHODS	Japanese patients who were treatment-naive ( n = 25 ) or prior null ( n = 12 ) or partial ( n = 5 ) responders received once-daily daclatasvir 10 mg or 60 mg or placebo in combination with alfa-2a and ribavirin .
-METHODS	Daclatasvir recipients with a protocol-defined response ( HCV RNA < 15 IU/ml at week 4 and undetectable at week 12 ) were treated for 24 weeks ; placebo recipients and patients without a protocol-defined response were treated for 48 weeks .
-RESULTS	Sustained virological response at 24 weeks post-treatment ( SVR24 ) was achieved by 89 % and 100 % of treatment-naive patients receiving daclatasvir 10 mg and 60 mg , respectively , versus 75 % in placebo recipients .
-RESULTS	Virological failure was more frequent in prior non-responder patients , with 50 % and 78 % achieving SVR24 in daclatasvir 10 mg and 60 mg groups , respectively .
-RESULTS	Adverse events occurred with similar frequency among treatment groups and were consistent with the adverse event profile of alfa-2a / ribavirin alone .
-RESULTS	The most commonly reported adverse events included pyrexia , alopecia , anaemia , lymphopenia , neutropenia , pruritus and diarrhoea .
-RESULTS	Three patients discontinued treatment due to anaemia .
-CONCLUSIONS	Daclatasvir combined with alfa-2a / ribavirin in treatment-naive patients showed greater efficacy than alfa-2a / ribavirin alone and was generally well tolerated .
-CONCLUSIONS	The 60-mg dose of daclatasvir achieved the highest rates of SVR24 in both treatment-naive and non-responder populations and will be evaluated in a Phase III clinical trial .
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-###24700991
-OBJECTIVE	To investigate the effect of abstention from breastfeeding , for an hour before and after each vaccination , on the immune responses of infants to two doses of rotavirus vaccine .
-METHODS	In Soweto , South Africa , mother-infant pairs who were uninfected with human immunodeficiency virus ( HIV ) were enrolled as they presented for the `` 6-week '' immunizations of the infants .
-METHODS	Each infant was randomly assigned to Group 1 - in which breastfeeding was deferred for at least 1 h before and after each dose of rotavirus vaccine - or Group 2 - in which unrestricted breastfeeding was encouraged .
-METHODS	Enzyme-linked immunosorbent assays were used to evaluate the titres of rotavirus-specific IgA in samples of serum collected from each infant immediately before each vaccine dose and 1 month after the second dose .
-METHODS	Among the infants , a fourfold or greater increase in titres of rotavirus-specific IgA following vaccination was considered indicative of seroconversion .
-RESULTS	The evaluable infants in Group 1 ( n = 98 ) were similar to those in Group 2 ( n = 106 ) in their baseline demographic characteristics and their pre-vaccination titres of anti-rotavirus IgA .
-RESULTS	After the second vaccine doses , geometric mean titres of anti-rotavirus IgA in the sera of Group-1 infants were similar to those in the sera of Group-2 infants ( P = 0.685 ) and the frequency of seroconversion in the Group-1 infants was similar to that in the Group-2 infants ( P = 0.485 ) .
-CONCLUSIONS	Among HIV-uninfected South African infants , abstention from breastfeeding for at least 1 h before and after each vaccination dose had no significant effect on the infants ' immune response to a rotavirus vaccine .
-
-###26077235
-OBJECTIVE	To determine long-term outcomes in a clinical trial evaluating the role of taxane type and schedule in operable breast cancer and evaluate the impact of obesity and black race on outcome .
-METHODS	A total of 4,954 eligible women with stage II to III breast cancer treated with four cycles of doxorubicin plus cyclophosphamide were randomly assigned to receive paclitaxel or docetaxel every 3 weeks for four doses or weekly for 12 doses using a 2 2 factorial design .
-METHODS	The primary end point was disease-free survival ( DFS ) .
-METHODS	Results are expressed as hazard ratios ( HRs ) from Cox proportional hazards models .
-METHODS	All P values are two sided .
-RESULTS	When compared with the standard every-3-week paclitaxel arm , after a median follow-up of 12.1 years , DFS significantly improved and overall survival ( OS ) marginally improved only for the weekly paclitaxel ( HR , 0.84 ; P = .011 and HR , 0.87 ; P = .09 , respectively ) and every-3-week docetaxel arms ( HR , 0.79 ; P = .001 and HR , 0.86 ; P = .054 , respectively ) .
-RESULTS	Weekly paclitaxel improved DFS and OS ( HR , 0.69 ; P = .010 and HR , 0.69 ; P = .019 , respectively ) in triple-negative breast cancer .
-RESULTS	For hormone receptor-positive , human epidermal growth factor receptor 2-nonoverexpressing disease , no experimental arm improved OS , and black race and obesity were associated with increased risk of breast cancer recurrence and death .
-CONCLUSIONS	Improved outcomes initially observed for weekly paclitaxel were qualitatively similar but quantitatively less pronounced with longer follow-up , although exploratory analysis suggested substantial benefit in triple-negative disease .
-CONCLUSIONS	Further research is required to understand why obesity and race influence clinical outcome in hormone receptor-positive disease .
-
-###25583753
-OBJECTIVE	Immune intervention trials in recent-onset type 1 diabetes would benefit from biomarkers associated with good therapeutic response .
-OBJECTIVE	In the previously reported randomized placebo-controlled anti-CD3 study ( otelixizumab ; GlaxoSmithKline ) , we tested the hypothesis that specific diabetes autoantibodies might serve this purpose .
-METHODS	In the included patients ( n = 40 otelixizumab , n = 40 placebo ) , - cell function was assessed as area under the curve ( AUC ) C-peptide release during a hyperglycemic glucose clamp at baseline ( median duration of insulin treatment : 6 days ) and every 6 months until 18 months after randomization .
-METHODS	( Auto ) antibodies against insulin ( I [ A ] A ) , GAD ( GADA ) , IA-2 ( IA-2A ) , and ZnT8 ( ZnT8A ) were determined on stored sera by liquid-phase radiobinding assay .
-RESULTS	At baseline , only better preserved AUC C-peptide release and higher levels of IAA were associated with better preservation of - cell function and lower insulin needs under anti-CD3 treatment .
-RESULTS	In multivariate analysis , IAA ( P = 0.022 ) or the interaction of IAA and C-peptide ( P = 0.013 ) independently predicted outcome together with treatment .
-RESULTS	During follow-up , good responders to anti-CD3 treatment ( i.e. , IAA ( + ) participants with relatively preserved - cell function [ 25 % of healthy control subjects ] ) experienced a less pronounced insulin-induced rise in I ( A ) A and lower insulin needs .
-RESULTS	GADA , IA-2A , and ZnT8A levels were not influenced by anti-CD3 treatment , and their changes showed no relation to functional outcome .
-CONCLUSIONS	There is important specificity of IAA among other diabetes autoantibodies to predict good therapeutic response of recent-onset type 1 diabetic patients to anti-CD3 treatment .
-CONCLUSIONS	If confirmed , future immune intervention trials in type 1 diabetes should consider both relatively preserved functional - cell mass and presence of IAA as inclusion criteria .
-
-###24745199
-OBJECTIVE	The aim of this study was to evaluate the efficacy of a 9-day accommodation protocol on reducing perceived discomfort while sitting on a stability ball ( SB ) ; trunk muscle activity levels and lumbar spinal postures were also considered .
-BACKGROUND	Previous studies have compared SB sitting with office chair sitting with few observed differences in muscle activity or posture ; however , greater discomfort during SB sitting has been reported .
-BACKGROUND	These findings may indicate an accommodation period is necessary to acclimate to SB sitting .
-METHODS	For this study , 6 males and 6 females completed two separate , 2-hr sitting sessions on an SB .
-METHODS	Half the participants completed a 9-day accommodation period between the visits , whereas the other half did not use an SB during the time .
-METHODS	On both occasions , self-reported perceived discomfort ratings were collected along with erector spinae and abdominal muscle activity and lumbar spinal postures .
-RESULTS	Discomfort ratings were reduced in female participants following the accommodation ; no effects on muscle activation or lumbar spine postures were observed .
-CONCLUSIONS	Accommodation training may reduce perceived low-back discomfort in females.Trunk muscle activity and lumbar spine postures during seated office work on an SB did not differ between groups ; however , greater sample power was required to conclusively address these variables .
-CONCLUSIONS	Regarding whether to use an SB in place of a standard office chair , this study indicates that females electing to use an SB can decrease discomfort by following an accommodation protocol ; no evidence was found to indicate that SB chair use will improve trunk strength or posture , even following an accommodation period .
-
-###24274323
-BACKGROUND	Dietary fiber ( DF ) intake in American children is suboptimal , increasing the risk of GI distress and contributing to poor diet quality .
-BACKGROUND	The objective of this study was to determine the effect of introducing two high-fiber snacks per day on gastrointestinal function as well as nutrient and food group intake in healthy children ages 7-11years old .
-METHODS	This study was a randomized controlled prospective intervention study of children 7-11years of age ( n = 81 ) attending a rural Midwestern elementary school .
-METHODS	Children were randomized by classroom to consume two high-fiber snacks per day ( total of 10-12g DF ) or their usual snacks for 8weeks .
-METHODS	Participants completed two 24-hour dietary recalls and a questionnaire about their GI health at baseline , mid-intervention ( week 4 ) , and post-intervention .
-METHODS	Dietary data was entered into NDSR 2011 and t-tests utilized to assess changes .
-METHODS	Analyses were completed in SAS 9.2 .
-RESULTS	Children consumed at least half their snack 94 % of the time when a snack was chosen ( 89 % of time ) .
-RESULTS	Participants in both the intervention and control group had healthy scores on the GI health questionnaire at all time points .
-RESULTS	The intervention group increased DF ( P = 0.0138 ) and whole grain ( WG ) intake ( P = 0.0010 ) at mid-intervention but after the intervention returned to their baseline DF intake ( P = 0.2205 ) and decreased their WG intake ( P = 0.0420 ) compared to baseline .
-RESULTS	Eating high-fiber snacks increased DF intake by 2.5 g per day ( 21 % increase ) , suggesting displacement of other fiber-rich foods .
-CONCLUSIONS	Study results indicate that children accept high-fiber foods , thus making these high-fiber foods and snacks consistently available will increase DF intake .
-
-###24686347
-OBJECTIVE	With the safety of laparoscopic cholecystectomy ( LC ) having been established , the current stress is on reducing the postoperative morbidity associated with this procedure .
-OBJECTIVE	Hence , this study was undertaken to compare the effect of low-pressure ( 8 mm Hg ) ( LPLC ) versus standard-pressure ( 12 mm Hg ) ( SPLC ) pneumoperitoneum on postoperative pain , respiratory and liver functions , the stress response , and the intraoperative surgeon comfort in patients undergoing LC .
-METHODS	Patients undergoing LC ( n = 43 ) were randomized into the LPLC ( 8 mm Hg ) group ( n = 22 ) and the SPLC ( 12 mm Hg ) group ( n = 21 ) .
-METHODS	Postoperative pain , changes in liver function , peak expiration flow rate , C-reactive protein level , and intraoperative surgeon comfort were assessed .
-RESULTS	The postoperative pain scores ( P = 0.003 , 0.000 , 0.001 , and 0.002 at 0 , 4 , 8 , and 24 h ) , total analgesic requirement ( P = 0.001 ) , and the number ( total and good ) of demands for analgesic in the first 24 hours ( P = 0.002 and 0.001 ) were lower in the LPLC group .
-RESULTS	The surgeon comfort in the LPLC group was significantly lesser ( P = 0.000 ) .
-RESULTS	The liver function and peak expiration flow rate did not show any significant changes .
-RESULTS	C-reactive protein levels varied significantly only at 24 hours postoperatively ( P = 0.001 ) .
-CONCLUSIONS	The use of low-pressure pneumoperitoneum ( 8 mm Hg ) for LC is associated with a significantly lower postoperative pain .
-CONCLUSIONS	However , the use of this low-pressure pneumoperitoneum can jeopardize the surgeon 's comfort .
-
-###24856872
-BACKGROUND	The 2009 KDIGO ( Kidney Disease : Improving Global Outcomes ) chronic kidney disease-mineral and bone disorder clinical practice guideline suggests correcting 25-hydroxyvitamin D3 ( 25 [ OH ] D ) levels < 30ng/mL in patients treated with maintenance hemodialysis , but does not provide a specific treatment protocol .
-METHODS	2-center , double-blind , randomized , 13-week , controlled trial followed by a 26-week open-label study .
-METHODS	55 adult maintenance hemodialysis patients with 25 ( OH ) D levels < 30ng/mL were recruited from June 2008 through October2009 .
-METHODS	Cholecalciferol , 25,000 IU , per week orally versus placebo for 13 weeks , then 26 weeks of individualized cholecalciferol prescription based on NKF-KDOQI ( National Kidney Foundation-Kidney Disease Outcomes Quality Initiative ) guidelines .
-RESULTS	Primary end point was the percentage of patients with 25 ( OH ) D levels30ng/mL at 13 weeks .
-RESULTS	Secondary outcomes included the percentage of patients with normal calcium , phosphorus , and intact parathyroidhormone ( iPTH ) blood levels .
-RESULTS	Safety measures included incidence of hypercalcemia and hypervitaminosis D.
-METHODS	Blood calcium and phosphate were measured weekly ; iPTH , 25 ( OH ) D , 1,25-dihydroxyvitamin D3 ( 1,25 [ OH ] 2D ) , and bone turnover markers , trimonthly ; fetuin A and fibroblast growth factor 23 ( FGF-23 ) serum levels and aortic calcification scores were determined at weeks 0 and39 .
-RESULTS	The primary end point significantly increased in the treatment group compared with the placebo group ( 61.5 % vs 7.4 % ; P < 0.001 ) , as well as 1,25 ( OH ) 2D levels ( 22.5 [ IQR , 15-26 ] vs 11 [ IQR , 10-15 ] pg/mL ; P < 0.001 ) and the proportion of patients achieving the target calcium level ( 76.9 % vs 48.2 % ; P = 0.03 ) .
-RESULTS	Incidence of hypercalcemia and phosphate and iPTH levels were similar between groups .
-RESULTS	The second 26-week study phase did not significantly modify the prevalence of 25 ( OH ) D level30ng/mL in patients issued from the placebo group .
-CONCLUSIONS	Small size of the study population .
-CONCLUSIONS	Oral weekly administration of 25,000 IU of cholecalciferol for 13 weeks is an effective , safe , inexpensive , and manageable way to increase 25 ( OH ) D and 1,25 ( OH ) 2D levels in hemodialysis patients .
-CONCLUSIONS	Further evaluation of clinical end points is suggested .
-
-###24490871
-BACKGROUND	Physical activity affords a wide range of physiological and psychological benefits for children and adolescents , yet many children with physical disabilities are insufficiently active to achieve these benefits .
-BACKGROUND	The StepUp program is a newly developed 6-week pedometer-based self-management program for children and adolescents with physical disability .
-BACKGROUND	Participants use a pedometer to undertake a 6-week physical activity challenge , with personalised daily step count goals set in consultation with a physiotherapist .
-BACKGROUND	The study aims to evaluate the effectiveness of the StepUp program , using a randomised control trial design .
-METHODS	A target sample of 70 young people with physical disabilities ( aged 8-17 years , ambulant with or without aid , residing in Adelaide ) will be recruited .
-METHODS	Participants will be randomly allocated to either intervention or control following completion of baseline assessments .
-METHODS	Assessments are repeated at 8 weeks ( immediately post intervention ) and 20 weeks ( 12 weeks post intervention ) .
-METHODS	The primary outcome is objective physical activity determined from 7 day accelerometry , and the secondary outcomes are exercise intention , physical self-worth , quality of life and fatigue .
-METHODS	Analyses will be undertaken on an intention-to-treat basis using random effects mixed modelling .
-CONCLUSIONS	This study will provide information about the potential of a low-touch and low-cost physical activity intervention for children and adolescents with cerebral palsy .
-BACKGROUND	Australian New Zealand Clinical Trials Registry ( ANZCTR ) : ACTRN12613000023752 .
-
-###24899241
-OBJECTIVE	To assess the effect of virtual reality distraction on pain among patients with a hand injury undergoing a dressing change .
-BACKGROUND	Virtual reality distraction can effectively alleviate pain among patients undergoing a dressing change .
-BACKGROUND	Clinical research has not addressed pain control during a dressing change .
-METHODS	A randomised controlled trial was performed .
-METHODS	In the first dressing change sequence , 98 patients were randomly divided into an experimental group and a control group , with 49 cases in each group .
-METHODS	Pain levels were compared between the two groups before and after the dressing change using a visual analog scale .
-METHODS	The sense of involvement in virtual environments was measured using the Pearson correlation coefficient analysis , which determined the relationship between the sense of involvement and pain level .
-RESULTS	The difference in visual analog scale scores between the two groups before the dressing change was not statistically significant ( t = 0196 , p > 005 ) , but the scores became statistically significant after the dressing change ( t = -30792 , p < 001 ) .
-RESULTS	The correlation between the sense of involvement in a virtual environment and pain level during the dressing was statistically significant ( R ( 2 ) = 05538 , p < 005 ) .
-CONCLUSIONS	Virtual reality distraction can effectively alleviate pain among patients with a hand injury undergoing a dressing change .
-CONCLUSIONS	Better results can be obtained by increasing the sense of involvement in a virtual environment .
-CONCLUSIONS	Virtual reality distraction can effectively relieve pain without side effects and is not reliant on a doctor 's prescription .
-CONCLUSIONS	This tool is convenient for nurses to use , especially when analgesics are unavailable .
-
-###24403824
-OBJECTIVE	To compare the safety , efficacy , and impact on stent graft positioning between rapid artificial cardiac pacing ( RACP ) , induced hypotension and sodium nitroprusside ( SNP ) induced hypotension during thoracic endovascular aortic repair ( TEVAR ) for Stanford B aortic dissection .
-METHODS	One hundred and sixty-eight patients , who were diagnosed with Stanford B aortic dissection and who underwent selective TEVAR in Guangdong General Hospital and the People 's Hospital of Baoan District , Shenzhen , People 's Republic of China , were enrolled in this study .
-METHODS	Patients were randomly divided into a RACP group ( n = 77 ) and a SNP group ( n = 91 ) .
-METHODS	During localization and deployment of the stent graft , hypotension was induced by RACP or intravenous SNP , according to randomization .
-METHODS	Hemodynamics , landing precision ( deviation from planned placement site ) , duration of procedure , renal function , neurocognitive function , and incidence of endoleaks and paraplegia/hemiplegia were compared .
-METHODS	Except for methods of inducing hypotension , TEVAR was performed according to the same protocol in each group .
-RESULTS	RACP was successfully performed in all patients assigned to the RACP group .
-RESULTS	Compared with the SNP group , blood pressure was significantly lower ( 435 versus 816 mmHg , P = 0.003 ) and the restoration time of blood pressure and the operation duration were significantly shorter ( 72 versus 45187 seconds , P < 0.001 ; 8715 versus 10618 minutes , P < 0.001 , respectively ) in the RACP group .
-RESULTS	Stent graft localization/deployment was more precise in the RACP group ( 21 versus 52 mm , P < 0.001 ) .
-RESULTS	Compared to baseline , there was no significant change after TEVAR in either group in regard to renal function , neurocognitive function , and incidence of endoleaks and paraplegia/hemiplegia .
-CONCLUSIONS	RACP can be safely applied to patients undergoing TEVAR for Stanford B dissection .
-CONCLUSIONS	RACP can shorten the operation duration and facilitate precise graft localization/deployment .
-
-###25719937
-OBJECTIVE	Elevated intraocular pressure ( IOP ) is a well-known adverse event associated with the fluocinolone acetonide implant ( FAI ) , but no data are available regarding factors associated with increased risk of IOP elevation in patients treated with the FAI .
-OBJECTIVE	To report risk factors that may predispose patients to elevated IOP after treatment with the FAI .
-METHODS	Data from 3 multicenter , 3-year , prospective , randomized , phase 2b/3 clinical trials evaluating the safety and efficacy of the FAI were pooled and analyzed .
-METHODS	Patients had no underlying glaucoma and at least one eye with a history of recurrent noninfectious uveitis affecting the posterior segment .
-METHODS	Patients were treated with 1 or more of the following : systemic therapy ( corticosteroids or other immunosuppressive drugs ) for at least 3 months before enrollment , 2 or more sub-Tenon capsule corticosteroid injections for uveitis management during the 6 months before enrollment , or systemic corticosteroid or sub-Tenon capsule corticosteroid injection therapy required for at least 2 separate recurrences within 6 months before enrollment .
-METHODS	Factors evaluated as risk factors for IOP elevation included age , sex , lens status , uveitis severity at enrollment , and location of uveitis .
-RESULTS	Data analyses were based on 641 eyes .
-RESULTS	A total of 351 eyes did not receive the FAI , whereas 290 eyes had the 0.59-mg FAI placed .
-RESULTS	An increase in IOP of 10 mm Hg or elevation to 30 mm Hg was seen in 60 untreated eyes ( 17.1 % ) and 188 treated eyes ( 65.1 % ) ( hazard ratio , 5.80 ; 95 % CI , 4.28-7 .70 ; P < .001 ) .
-RESULTS	A total of 8 untreated eyes ( 2.3 % ) required surgical intervention for elevated IOP compared with 93 treated eyes ( 32.1 % ) ( hazard ratio , 16.48 ; 95 % CI , 8.24-32 .96 ; P < .001 ) .
-RESULTS	In patients with the FAI , younger age , male sex , and phakic lens status were associated with higher risk of IOP elevation and the need for glaucoma surgery ( P = .003 , P < .001 , and P < .001 , respectively ) .
-CONCLUSIONS	Patients receiving the FAI are at higher risk of developing an IOP increase of 10 mm Hg or an absolute IOP of 30 mm Hg when compared with patients without the FAI .
-CONCLUSIONS	Patients who are male , younger , and phakic are at an even higher risk for elevated IOP and possibly glaucoma surgery .
-
-###24881853
-BACKGROUND	Liver abscess is a rare but potentially fatal complication of transarterial chemoembolization .
-BACKGROUND	Other than for biliary abnormalities , risk factors for liver abscess formation after transarterial chemoembolization have rarely been discussed .
-OBJECTIVE	To identify other risk factors of liver abscess after transarterial chemoembolization in patients with hepatocellular carcinoma .
-METHODS	Data for 5299 patients with hepatocellular carcinoma who underwent transarterial chemoembolization from July 1999 to December 2009 were retrospectively reviewed .
-METHODS	72 patients who experienced liver abscess after transarterial chemoembolization were enrolled as a case group , which was compared with a randomly selected control group ( n = 1009 ) of patients who did not develop liver abscess after transarterial chemoembolization .
-RESULTS	Pneumobilia , type 2 biliary abnormality , type 1 biliary abnormality , diabetes mellitus , tumour number ( 3 ) , tumour size ( 3cm ) , and tumour necrosis on the pre-transarterial chemoembolization computed tomography , and gelfoam embolization and vessel injury during transarterial chemoembolization were all significant predisposing factors for liver abscess after transarterial chemoembolization .
-RESULTS	A prediction model for postembolization liver abscess was developed from these risk factors .
-CONCLUSIONS	The group of patients with risk scores greater than 71 showed a significantly increased risk of liver abscess after transarterial chemoembolization .
-CONCLUSIONS	These high-risk patients should be monitored carefully after transarterial chemoembolization .
-
-###24302273
-OBJECTIVE	Vascular disease is included in a risk scoring system to predict stroke in patients with non-valvular atrial fibrillation ( AF ) .
-OBJECTIVE	This post hoc analysis of ROCKET AF aimed to determine the absolute rates of stroke and bleeding , and the relative effectiveness and safety of rivaroxaban vs. warfarin in patients with and without peripheral artery disease ( PAD ) .
-OBJECTIVE	Peripheral artery disease was defined on the case-report form as the presences of intermittent claudication , amputation for arterial insufficiency , vascular reconstruction , bypass surgery , or percutaneous intervention to the extremities , or previously documented abdominal aortic aneurysm .
-RESULTS	ROCKET AF was a double-blind , double-dummy , randomized-controlled trial comparing rivaroxaban and warfarin for the prevention of stroke or systemic embolism .
-RESULTS	A total of 839 ( 5.9 % ) patients in ROCKET AF had PAD .
-RESULTS	Patients with and without PAD had similar rates of stroke or systemic embolism [ HR : 1.04 , 95 % CI ( 0.72 , 1.50 ) , P = 0.84 ] and major or non-major clinically relevant ( NMCR ) bleeding [ HR : 1.11 , 95 % CI ( 0.96 , 1.28 ) , P = 0.17 ] , respectively .
-RESULTS	The efficacy of rivaroxaban when compared with warfarin for the prevention of stroke or systemic embolism was similar in patients with PAD ( HR : 1.19 , 95 % CI : 0.63-2 .22 ) and without PAD ( HR : 0.86 , 95 % CI : 0.73-1 .02 ; interaction P = 0.34 ) .
-RESULTS	There was a significant interaction for major or NMCR bleeding in patients with PAD treated with rivaroxaban compared with warfarin ( HR : 1.40 , 95 % CI : 1.06-1 .86 ) compared with those without PAD ( HR : 1.03 , 95 % CI : 0.95-1 .11 ; interaction P = 0.037 ) .
-CONCLUSIONS	Patients with PAD in ROCKET AF did not have a statistically significant higher risk of stroke or systemic embolism than patients without PAD , and there were similar efficacy outcomes in patients treated with rivaroxaban and warfarin .
-CONCLUSIONS	In PAD patients , there was a higher risk of major bleeding or NMCR bleeding with rivaroxaban when compared with warfarin ( interaction P = 0.037 ) .
-CONCLUSIONS	Further investigation is warranted to validate this subgroup analysis and determine the optimal treatment in this high-risk cohort of AF patients with PAD .
-
-###24246588
-BACKGROUND	Family members of patients with coronary artery disease ( CAD ) have higher risk of vascular events .
-BACKGROUND	We conducted a trial to determine if a family heart-health intervention could reduce their risk of CAD .
-METHODS	We assessed coronary risk factors and randomized 426 family members of patients with CAD to a family heart-health intervention ( n = 211 ) or control ( n = 215 ) .
-METHODS	The intervention included feedback about risk factors , assistance with goal setting and counselling from health educators for 12 months .
-METHODS	Reports were sent to the primary care physicians of patients whose lipid levels and blood pressure exceeded threshold values .
-METHODS	All participants received printed materials about smoking cessation , healthy eating , weight management and physical activity ; the control group received only these materials .
-METHODS	The main outcomes ( ratio of total cholesterol to high-density lipoprotein [ HDL ] cholesterol ; physical activity ; fruit and vegetable consumption ) were assessed at 3 and 12 months .
-METHODS	We examined group and time effects using mixed models analyses with the baseline values as covariates .
-METHODS	The secondary outcomes were plasma lipid levels ( total cholesterol , low-density lipoprotein cholesterol , HDL cholesterol and triglycerides ) ; glucose level ; blood pressure ; smoking status ; waist circumference ; body mass index ; and the use of blood pressure , lipid-lowering and smoking cessation medications .
-RESULTS	We found no effect of the intervention on the ratio of total cholesterol to HDL cholesterol .
-RESULTS	However , participants in the intervention group reported consuming more fruit and vegetables ( 1.2 servings per day more after 3 mo and 0.8 servings at 12 mo ; p < 0.001 ) .
-RESULTS	There was a significant group by time interaction for physical activity ( p = 0.03 ) .
-RESULTS	At 3 months , those in the intervention group reported 65.8 more minutes of physical activity per week ( 95 % confidence interval [ CI ] 47.0-84 .7 min ) .
-RESULTS	At 12 months , participants in the intervention group reported 23.9 more minutes each week ( 95 % CI 3.9-44 .0 min ) .
-CONCLUSIONS	A health educator-led heart-health intervention did not improve the ratio of total cholesterol to HDL cholesterol but did increase reported physical activity and fruit and vegetable consumption among family members of patients with CAD .
-CONCLUSIONS	Hospitalization of a spouse , sibling or parent is an opportunity to improve cardiovascular health among other family members .
-BACKGROUND	clinicaltrials.gov , no NCT00552591 .
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-###25133471
-OBJECTIVE	To evaluate karyotype-specific ear and hearing problems in young-adult patients with Turner syndrome ( TS ) and assess the effects of previous treatment with oxandrolone ( Ox ) .
-METHODS	Double-blind follow-up study .
-METHODS	University hospital .
-METHODS	Sixty-five TS patients ( mean age , 24.3 yr ) previously treated with growth hormone combined with placebo , Ox 0.03 mg/kg per day , or Ox 0.06 mg/kg per day from the age of 8 years and estrogen from the age of 12 years .
-METHODS	Ear examination was performed according to standard clinical practice .
-METHODS	Air - and bone conduction thresholds were measured in decibel hearing level .
-METHODS	We compared patients with total monosomy of the short arm of the X chromosome ( Xp ) , monosomy 45 , X and isochromosome 46 , X , i ( Xq ) , with patients with a partial monosomy Xp , mosaicism or other structural X chromosomal anomalies .
-METHODS	We assessed the effect of previous Ox treatment .
-RESULTS	Sixty-six percent of the patients had a history of recurrent otitis media .
-RESULTS	We found hearing loss in 66 % of the ears , including pure sensorineural hearing loss in 32 % .
-RESULTS	Hearing thresholds in patients with a complete monosomy Xp were about 10 dB worse compared with those in patients with a partial monosomy Xp .
-RESULTS	Air - and bone conduction thresholds were not different between the placebo and Ox treatment groups .
-CONCLUSIONS	Young-adult TS individuals frequently have structural ear pathology , and many suffer from hearing loss .
-CONCLUSIONS	This indicates that careful follow-up to detect ear and hearing problems is necessary , especially for those with a monosomy 45 , X or isochromosome 46 , X , i ( Xq ) .
-CONCLUSIONS	Ox does not seem to have an effect on hearing .
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-###25549577
-OBJECTIVE	The aim was to investigate whether the fascia suture technique ( FST ) can reduce access closure time and procedural costs compared with the Prostar technique ( Prostar ) in patients undergoing endovascular aortic repair and to evaluate the short - and mid-term outcomes of both techniques .
-METHODS	In this two center trial , 100 patients were randomized to access closure by either FST or Prostar between June 2006 and December 2009 .
-METHODS	The primary endpoint was access closure time .
-METHODS	Secondary outcome measures included access related costs and evaluation of the short - and mid-term complications .
-METHODS	Evaluation was performed peri - and post-operatively , at discharge , at 30 days and at 6 months follow up .
-RESULTS	The median access closure time was 12.4 minutes for FST and 19.9 minutes for Prostar ( p < .001 ) .
-RESULTS	Prostar required a 54 % greater procedure time than FST , mean ratio 1.54 ( 95 % CI 1.25-1 .90 , p < .001 ) according to regression analysis .
-RESULTS	Adjusted for operator experience the mean ratio was 1.30 ( 95 % CI 1.09-1 .55 , p = .005 ) and for patient body mass index 1.59 ( 95 % CI 1.28-1 .96 , p < .001 ) .
-RESULTS	The technical failure rate for operators at proficiency level was 5 % ( 2/40 ) compared with 28 % ( 17/59 ) for those at the basic level ( p = .003 ) .
-RESULTS	The proficiency level group had a technical failure rate of 4 % ( 1/26 ) for FST and 7 % ( 1/14 ) for Prostar , p = 1.00 , while corresponding rates for the basic level group were 27 % ( 6/22 ) for FST and 30 % ( 11/37 ) for Prostar ( p = .84 ) .
-RESULTS	There was a significant difference in cost in favor of FST , with a median difference of 800 ( 95 % CI 710-927 , p < .001 ) .
-CONCLUSIONS	In aortic endovascular repair FST is a faster and cheaper technique than the Prostar technique .
-
-###25003731
-BACKGROUND	Correct use of intranasal corticosteroid ( INCS ) and compliance with treatment is very important for the treatment of allergic rhinitis ( AR ) .
-BACKGROUND	An animated cartoon-aided teaching method for INCS administration was created to decrease the workload of health care professionals .
-BACKGROUND	The aim of this study was to compare the performance of children with AR in using INCS between a group who were instructed using animated cartoon-aided teaching and those receiving only an oral presentation without demonstration .
-METHODS	The study was a prospective randomized controlled trial in children aged 5-16 years with moderate to severe intermittent or persistent AR who had never used INCS .
-METHODS	The patients were randomly divided into 2 groups ; 1 ) those receiving teaching about how to use INCS by an oral presentation without demonstration and 2 ) by animated cartoon-aided teaching .
-METHODS	The performance of the children was recorded after the initial training using a five-point checklist .
-METHODS	If they were unable to use the INCS correctly after the first teaching session , the same instructions were repeated and a second assessment was performed .
-RESULTS	A total of 80 patients , 40 each group , underwent randomization .
-RESULTS	The rate of achieving competency for the patients after the first instruction using the animated cartoon-aided teaching group was significantly higher than that for the oral presentation group ( 57.5 % VS 27.5 % ; P = 0.007 ) .
-RESULTS	The cumulative success rate for the second assessment of the animated cartoon-aided group was also significantly higher than for those receiving only an oral presentation ( 95 % VS 60 % , P = 0.004 ) .
-CONCLUSIONS	With regard to mastering the correct method for INCS usage , instruction using animated cartoon-aided teaching is better than oral presentation without demonstration .
-CONCLUSIONS	However , the best method for teaching patients how to use INCS is a combination of oral explanation and demonstration by cartoon-aided teaching .
-CONCLUSIONS	The teaching should be repeated periodically to remind patients of the correct method for INCS usage .
-
-###25436661
-OBJECTIVE	In rheumatoid arthritis ( RA ) and osteoarthritis ( OA ) forefoot involvement causes disability and metatarsalgia .
-OBJECTIVE	Our objective was to evaluate , in RA and OA patients , the efficacy of two protocols combining insoles in polypropylene terephtalate ( PPT ) and custom silicone orthoses for toes on disability and metatarsalgia .
-METHODS	Twenty-four women ( 13 with OA , 11 with RA ) with metatarsalgia were treated with two protocols : group A ( protocol A ) wore PPT insoles ( T1 ) for 30 days and for another 30 days silicone orthosis for toes were added ( T2 ) .
-METHODS	Group B ( protocol B ) wore PPT insoles and silicone orthosis ( T1 ) for 30 days and in the following 30 days only insoles ( T2 ) .
-METHODS	At T0 , T1 and T2 , pain , disability and function ( Foot Function Index - FFI ) , pressure ( KPA ) and plantar contact areas ( cm2 ) ( baropodometer ) , and gait spatial-temporal parameters ( GAITRite ) were assessed .
-RESULTS	At T0 versus T2 , both protocols reduced FFI-pain , - disability and - functional limitation ( p < 0.05 ) , with better results of protocol A than protocol B ( p < 0.05 ) for FFI-pain and - disability .
-RESULTS	Both protocols reduced baropodometer foot plantar pressures ( p < 0.001 ) , with better results for protocol A for right foot pressures ( p < 0.05 ) and increased foot contact areas ( p < 0.05 ) , with no difference between them ( p = NS ) .
-RESULTS	Gait parameters were not significantly changed by both protocols ( p = NS ) .
-CONCLUSIONS	In patients with RA and OA with metatarsalgia , the synergic action of silicone toe orthosis and PPT insoles improves FFI , reduces foot plantar pressures and increases foot plantar contact areas .
-CONCLUSIONS	Protocol A , using firstly insoles and then adding silicone toe orthoses , is the more efficacious .
-
-###24635872
-BACKGROUND	Persistent behavioural difficulties are common following paediatric acquired brain injury ( ABI ) .
-BACKGROUND	Parents and families also experience heightened stress , psychological symptoms and burden , and there is evidence of a reciprocal relationship between parent and child functioning , which may be mediated by the adoption of maladaptive parenting practices .
-BACKGROUND	Despite this , there is currently a paucity of research in family interventions in this population .
-BACKGROUND	The aim of this study was to determine the efficacy of Stepping Stones Triple P : Positive Parenting Program ( SSTP ) , with an Acceptance and Commitment Therapy ( ACT ) workshop , in improving child outcomes and parenting practices following paediatric ABI .
-METHODS	Fifty-nine parents of children ( mean age 7 years , SD 3 years , 1 month ; 35 males , 24 females ) with ABI ( Traumatic injuries 58 % , Tumour 17 % , Encephalitis or meningitis 15 % , Cardiovascular accident 7 % , Hypoxia 3 % ) who were evidencing at least mild behaviour problems were randomly assigned to treatment or care-as-usual conditions over 10 weeks .
-METHODS	Mixed-model repeated-measures linear regression analyses were conducted to compare conditions from pre - to postintervention on child behavioural and emotional functioning ( Eyberg Child Behavior Inventory , Strengths and Difficulties Questionnaire ) and dysfunctional parenting style ( Parenting Scale ) .
-METHODS	Assessment of maintenance of change was conducted at a 6-month follow-up .
-METHODS	The trial was registered on Australian New Zealand Clinical Trials Registry ( ID : ACTRN12610001051033 , www.anzctr.org.au ) .
-RESULTS	Significant time-by-condition interactions were identified on number and intensity of child behaviour problems , child emotional symptoms and parenting laxness and overreactivity , indicating significant improvements in the treatment condition , with medium-to-large effect sizes .
-RESULTS	Most improvements were maintained at 6 months .
-CONCLUSIONS	Group parenting interventions incorporating Triple P and ACT may be efficacious in improving child and parenting outcomes following paediatric ABI .
-
-###25363189
-OBJECTIVE	The purpose of this study is the comparison of the effect of vitamin B1 and fish oil with together on severity and duration of dysmenorrhea , and if it is effective , we can administrative both of them with less complication to compare with other chemical drugs which has many disadvantages .
-METHODS	High school of Urmia city , between March 2008 and June 2008 .
-METHODS	This study has a double-blind clinical trial design .240 high school female students with dysmenorrhea by a randomized Method were followed up in a double-blind , randomized , placebo-controlled study by dividing into four groups with 60 members .
-METHODS	The daily supplement was vit B1 ( 100 mg/day and fish oil pearl 500 mg/day ) , taken as a single dose starting at the beginning of the menstrual cycle and continued for 2 consecutive months .
-RESULTS	Intensity of pain in three experimental groups ( Vit B1 , fish oil and both of them ) had significant difference comparing placebo group and intensity of pain had reduced .
-RESULTS	( p < 0.001 ) , ( p = 0.018 ) , ( p < 0.001 ) VS in placebo group ( p = 0.79 ) .
-RESULTS	Duration of pain had significantly reduced in all three experimental groups compared with placebo group .
-RESULTS	( p = 0.004 ) , ( p = 0.008 ) , ( p < 0.001 ) VS in placebo group ( p = 0.32 ) .
-RESULTS	In all of drugs , results ( mean ) was better at the end of the second month than the first month .
-CONCLUSIONS	Fish oil and vit B1 effects on treatment of primary dysmenorrhea were similar , but vit B1 has less complications and it was more acceptable .
-CONCLUSIONS	We mixed them and compared its results with vit B1 , fish oil and placebo separately .
-CONCLUSIONS	Pain duration is the least in Vitamin B1 tablets compare with the others , but its duration was minimum in complex of Vitamin B1 tablets and fish oil capsules .
-CONCLUSIONS	Due to good effects of vitamin B1 and fish oil on symptoms of dysmenorrhea , using of them is suggested .
-
-###24763929
-OBJECTIVE	Exercise using virtual reality ( VR ) has improved balance in adults with traumatic brain injury and community-dwelling older adults .
-OBJECTIVE	Rigorous randomized studies regarding its efficacy , safety , and applicability with individuals after stroke are lacking .
-OBJECTIVE	The purpose of this study was to determine whether an adjunct VR therapy improves balance , mobility , and gait in stroke rehabilitation inpatients .
-METHODS	A blinded randomized controlled trial studying 59 stroke survivors on an inpatient stroke rehabilitation unit was performed .
-METHODS	The treatment group ( n = 30 ) received standard stroke rehabilitation therapy plus a program of VR exercises that challenged balance ( eg , soccer goaltending , snowboarding ) performed while standing .
-METHODS	The control group ( n = 29 ) received standard stroke rehabilitation therapy plus exposure to identical VR environments but whose games did not challenge balance ( performed in sitting ) .
-METHODS	VR training consisted of 10 to 12 thirty-minute daily sessions for a 3-week period .
-METHODS	Objective outcome measures of balance and mobility were assessed before , immediately after , and 1 month after training .
-RESULTS	Confidence intervals and effect sizes favored the treatment group on the Timed Up and Go and the Two-Minute Walk Test , with both groups meeting minimal clinical important differences after training .
-RESULTS	More individuals in the treatment group than in the control group showed reduced impairment in the lower extremity as measured by the Chedoke McMaster Leg domain ( P = 0.04 ) immediately after training .
-CONCLUSIONS	This VR exercise intervention for inpatient stroke rehabilitation improved mobility-related outcomes .
-CONCLUSIONS	Future studies could include nonambulatory participants as well as the implementation strategies for the clinical use of VR .
-BACKGROUND	http://www.ANZCTR.org.au/ .
-BACKGROUND	Unique identifier : ACTRN12613000710729 .
-
-###25446768
-BACKGROUND	Amino-acid-based formulas ( AAFs ) are recommended for children with cow 's milk protein allergy ( CMPA ) failing to respond to extensively hydrolyzed formulas ( eHFs ) .
-OBJECTIVE	This study aimed to assess the tolerance/hypoallergenicity and efficacy of a thickened AAF ( TAAF ) in these infants .
-METHODS	This multicenter , double-blind , randomized controlled trial ( NCT01940068 ) compared 3-month feeding with a pectin-based TAAF ( Novalac ( ) , United Pharmaceuticals , Paris , France ) and a commercially available `` reference '' AAF ( RAAF ; Neocate ( ) , Nutricia , Germany ) in infants aged < 18 months with CMPA and persistent allergy symptoms with eHF feeding .
-METHODS	Reported here are the results of an interim analysis after 1 month of feeding .
-RESULTS	Of the 86 infants randomized , CMPA with eHF intolerance was confirmed in 75 infants ; all of them tolerated the allocated AAFs .
-RESULTS	The major allergic symptom disappeared within 1 month in 61.9 and 51.5 % and regurgitations disappeared in 66.7 and 42.3 % of infants who received TAAF and RAAF , respectively .
-RESULTS	Infants had significantly more normal stools ( soft or formed consistency ) with the TAAF ( 90.5 vs. 66.7 % ; p = 0.011 ) .
-RESULTS	From baseline , daily family life significantly improved with both AAFs : crying time decreased by 97.3 ( p < 0.001 ) and 28.6 min ( p = 0.014 ) and sleeping time increased by 64.6 ( p = 0.009 ) and 29.0 min with TAAF and RAAF , respectively .
-RESULTS	At day 30 , weight and body mass index z-score gains were 0.1 and 0.2 with TAAF and 0.2 and 0.0 with RAAF .
-CONCLUSIONS	Both AAFs were well tolerated by infants with CMPA and eHF intolerance and ensured appropriate growth , with the TAAF providing additional comfort .
-
-###25384603
-OBJECTIVE	The aim of this study was to investigate the influence of perioperative N-acetylcysteine ( NAC ) administration , a known antioxidant , on the incidence of acute kidney injury ( AKI ) after off-pump coronary bypass surgery ( OPCAB ) in patients with known risk factors of AKI .
-METHODS	One hundred and seventeen patients with 1 of the following risk factors of AKI were randomized into either the control ( n = 57 ) or the NAC ( n = 60 ) group ; ( i ) preoperative serum creatinine > 1.4 mg/dL ; ( ii ) left ventricular ejection fraction < 35 % or congestive heart failure ( iii ) age > 70 years ( iv ) diabetes or ( v ) re-operation .
-METHODS	Patients in the NAC group received 150mg/kg of NAC IV bolus at anaesthetic induction followed by a continuous infusion at 150mg/kg per day for 24h .
-METHODS	AKI was diagnosed based on Acute Kidney Injury Network criteria during 48h postoperatively .
-RESULTS	The incidence of AKI was 32 % ( 19/60 ) and 35 % ( 20/57 ) in the control and the NAC group , respectively ( P = 0.695 ) .
-RESULTS	The serum concentrations of creatinine and cystatin C were similar between the groups throughout the study period .
-RESULTS	Fluid balance including the amount of blood loss and transfusion requirement were similar between the groups except the amount of postoperative urine output , which was higher in the control group compared with the NAC group ( 55281247mL vs. 49821185mL , control vs. NAC , P = 0.017 ) .
-CONCLUSIONS	Perioperative administration of NAC did not prevent the development of postoperative AKI after OPCAB in highly susceptible patients to AKI .
-
-###24399101
-OBJECTIVE	To evaluate the efficacy of 2 computer attention training systems administered in school for children with attention-deficit hyperactivity disorder ( ADHD ) .
-METHODS	Children in second and fourth grade with a diagnosis of ADHD ( n = 104 ) were randomly assigned to neurofeedback ( NF ) ( n = 34 ) , cognitive training ( CT ) ( n = 34 ) , or control ( n = 36 ) conditions .
-METHODS	A 2-point growth model assessed change from pre-post intervention on parent reports ( Conners 3-Parent [ Conners 3-P ] ; Behavior Rating Inventory of Executive Function [ BRIEF ] rating scale ) , teacher reports ( Swanson , Kotkin , Agler , M-Flynn and Pelham scale [ SKAMP ] ; Conners 3-Teacher [ Conners 3-T ] ) , and systematic classroom observations ( Behavioral Observation of Students in Schools [ BOSS ] ) .
-METHODS	Paired t tests and an analysis of covariance assessed change in medication .
-RESULTS	Children who received NF showed significant improvement compared with those in the control condition on the Conners 3-P Attention , Executive Functioning and Global Index , on all BRIEF summary indices , and on BOSS motor/verbal off-task behavior .
-RESULTS	Children who received CT showed no improvement compared to the control condition .
-RESULTS	Children in the NF condition showed significant improvements compared to those in the CT condition on Conners 3-P Executive Functioning , all BRIEF summary indices , SKAMP Attention , and Conners 3-T Inattention subscales .
-RESULTS	Stimulant medication dosage in methylphenidate equivalencies significantly increased for children in the CT ( 8.54 mg ) and control ( 7.05 mg ) conditions but not for those in the NF condition ( 0.29 mg ) .
-CONCLUSIONS	Neurofeedback made greater improvements in ADHD symptoms compared to both the control and CT conditions .
-CONCLUSIONS	Thus , NF is a promising attention training treatment intervention for children with ADHD .
-
-###25281755
-BACKGROUND	The efficacy of TCN-032 , a human monoclonal antibody targeting a conserved epitope on M2e , was explored in experimental human influenza .
-METHODS	Healthy volunteers were inoculated with influenza A/Wisconsin/67 / 2005 ( H3N2 ) and received a single dose of the study drug , TCN-032 , or placebo 24 hours later .
-METHODS	Subjects were monitored for symptoms , viral shedding , and safety , including cytokine measurements .
-METHODS	Oseltamivir was administered 7 days after inoculation .
-RESULTS	Although the primary objective of reducing the proportion of subjects developing any grade 2 influenza symptom or pyrexia , was not achieved , TCN-032-treated subjects showed 35 % reduction ( P = .047 ) in median total symptom area under the curve ( days 1-7 ) and 2.2 log reduction in median viral load area under the curve ( days 2-7 ) by quantitative polymerase chain reaction ( P = .09 ) compared with placebo-treated subjects .
-RESULTS	TCN-032 was safe and well tolerated with no additional safety signals after administration of oseltamivir .
-RESULTS	Serum cytokine levels ( interferon , tumor necrosis factor , and interleukin 8 and 10 ) were similar in both groups .
-RESULTS	Genotypic and phenotypic analyses showed no difference between virus derived from subjects after TCN-032 treatment and parental strain .
-CONCLUSIONS	These data indicate that TCN-032 may provide immediate immunity and therapeutic benefit in influenza A infection , with no apparent emergence of resistant virus .
-CONCLUSIONS	TCN-032 was safe with no evidence of immune exacerbation based on serum cytokine expression .
-CONCLUSIONS	Clinicaltrials.gov registry number.NCT01719874 .
-
-###24809142
-OBJECTIVE	To observe the impact of the diverse caloric energy intake on the outcomes and occurrence rate of complications in septic patients .
-METHODS	A prospective single-blind randomized controlled trial was conducted .
-METHODS	158 cases of septic patients in intensive care unit ( ICU ) were enrolled and randomly assigned to three groups according to their different target value of nutrition : group A [ measurements of resting energy expenditure ( MREE ) < 90 % J , B ( MREE 90 % -110 % ) and C ( MREE > 110 % ) .
-METHODS	The caloric intake , mechanical ventilation duration ( MVD ) , nosocomial infection rate , 28-day and 60-day mortality were analyzed .
-RESULTS	Daily energy intake in 7 days after ICU admission was as follows : the difference in target value of nutrition ( kJ/d : 7 075.0 1 046.5 , 5 667.8 1 908.8,4 428.8 1 377.8 ) , calory intake ( k ] / d : 4 671.6 1 205.6 , 5 655.3 1 373.0 , 6 053.0 1 557.2 ) , enteral nutrition value ( kJ/d : 2 051.1 1 046.5 , 3 980.9 1 586.5 , 5 337.1 2 921.8 ) and average intake rate [ ( 66.0 15.8 ) % , ( 100.0 5.7 ) % , ( 134.0 19.7 ) % J , and they were statistically significant difference among A , B , C groups ( all P < 0.05 ) .
-RESULTS	The parenteral nutrition in group C were much higher than that in group A and group B ( kJ/d : 2 055.3 273.4 vs. 427.0 273.4 , 473.0 332.0 , both P < 0.05 ) .
-RESULTS	The calories provided by glucose and diprivan were similar among three groups .
-RESULTS	The MVD and ICU stay were shorter in group B than that in groups A and C [ MVD ( days ) : 8.4 6.3 vs. 11.0 8.2 , 17.8 13.0 , P > 0.05 and P < 0.05 ; ICU stay ( days ) : 11.0 6.4 vs. 14.9 9.6 , 17.8 13.0 , respectively , P > 0.05 and P < 0.05 ] .
-RESULTS	The total hospital stay ( days : 32.0 22.5 , 26.8 7.0 , 30.4 21.4 ) and nosocomial infection rate [ 91.1 % ( 51156 ) , 84.0 % ( 42/50 ) , 90.4 % ( 4 7/52 ) J were similar among A , B , C groups ( all P > 0.05 ) .
-RESULTS	There was no difference in survival rate at 28 days among three groups as shown by the Kaplan-Meier survival curve ( F = 3.145 , P = 0.076 ) .
-RESULTS	The survival rate at 60 days showed a tendency of lowering in groups A and C , especially in group C ( F = 9.284 , P = 0.010 ) .
-CONCLUSIONS	Both higher and lower caloric energy intake may be associated with an adverse impact , but appropriate caloric intake would improve the outcome and reduce the complication rate in septic patients .
-
-###26138912
-OBJECTIVE	A prognostic model for 5-year overall survival ( OS ) , consisting of recursive partitioning analysis ( RPA ) and a nomogram , was developed for patients with early-stage non-small cell lung cancer ( ES-NSCLC ) treated with stereotactic ablative radiation therapy ( SABR ) .
-METHODS	A primary dataset of 703 ES-NSCLC SABR patients was randomly divided into a training ( 67 % ) and an internal validation ( 33 % ) dataset .
-METHODS	In the former group , 21 unique parameters consisting of patient , treatment , and tumor factors were entered into an RPA model to predict OS .
-METHODS	Univariate and multivariate models were constructed for RPA-selected factors to evaluate their relationship with OS .
-METHODS	A nomogram for OS was constructed based on factors significant in multivariate modeling and validated with calibration plots .
-METHODS	Both the RPA and the nomogram were externally validated in independent surgical ( n = 193 ) and SABR ( n = 543 ) datasets .
-RESULTS	RPA identified 2 distinct risk classes based on tumor diameter , age , World Health Organization performance status ( PS ) and Charlson comorbidity index .
-RESULTS	This RPA had moderate discrimination in SABR datasets ( c-index range : 0.52-0 .60 ) but was of limited value in the surgical validation cohort .
-RESULTS	The nomogram predicting OS included smoking history in addition to RPA-identified factors .
-RESULTS	In contrast to RPA , validation of the nomogram performed well in internal validation ( r ( 2 ) = 0.97 ) and external SABR ( r ( 2 ) = 0.79 ) and surgical cohorts ( r ( 2 ) = 0.91 ) .
-CONCLUSIONS	The Amsterdam prognostic model is the first externally validated prognostication tool for OS in ES-NSCLC treated with SABR available to individualize patient decision making .
-CONCLUSIONS	The nomogram retained strong performance across surgical and SABR external validation datasets .
-CONCLUSIONS	RPA performance was poor in surgical patients , suggesting that 2 different distinct patient populations are being treated with these 2 effective modalities .
-
-###24928191
-OBJECTIVE	To investigate ( 1 ) the effect of spray and stretch versus control on reducing postneedling soreness of 1 latent myofascial trigger point ( MTrP ) and ( 2 ) whether higher levels of psychological distress are associated with increased postneedling pain intensity .
-METHODS	A 72-hour follow-up , single-blind randomized controlled trial .
-METHODS	University community .
-METHODS	Healthy volunteers ( N = 70 ; 40 men , 30 women ) aged 18 to 36 years ( mean age , 214y ) with latent MTrP in 1 upper trapezius muscle .
-METHODS	All subjects received a dry needling application over the upper trapezius muscle .
-METHODS	Then , participants were randomly divided into 2 groups : an intervention group , which received spray and stretch over the needled trapezius muscle , and a control group , which did not receive any intervention .
-METHODS	Visual analog scale ( at postneedling , posttreatment , and 6 , 12 , 24 , 48 , and 72h after needling ) , pressure pain threshold ( at preneedling , postneedling , and 24 and 48h after needling ) .
-METHODS	Psychological distress was evaluated by using the Symptom Checklist-90-Revised .
-RESULTS	Repeated-measures analysis of variance demonstrated a significant interaction between group and time ( F3 ,204.8 = 3.19 ; P < .05 ; p ( 2 ) = .04 ) for changes in postneedling soreness .
-RESULTS	Between-group differences were significant only immediately after intervention ( P = .002 ) , and there were no differences found between groups after 6 hours of the intervention ( P > .05 ) .
-RESULTS	Repeated measures of covariance showed that none of the psychological covariates affected these results .
-RESULTS	Somatization , anxiety , interpersonal sensitivity , and hostility were significantly correlated ( P < .05 ) with postneedling pain intensity .
-RESULTS	Repeated-measures analysis of variance did not show a significant effect of spray and stretch on mechanical hyperalgesia ( F2 .6,175 = 1.9 ; P = .131 ; p ( 2 ) = .02 ) .
-CONCLUSIONS	The spray and stretch had a short-term ( < 6h ) effect in reducing postneedling soreness of a latent MTrP .
-CONCLUSIONS	Pressure pain threshold did not significantly change after spray and stretch .
-CONCLUSIONS	Psychological factors are related to postneedling pain .
-
-###24385634
-OBJECTIVE	To longitudinally examine gender and racial disparities in driving cessation among older adults .
-METHODS	Data came from the Advanced Cognitive Training for Independent and Vital Elderly ( ACTIVE ) Study ( N = 1,789 ) .
-METHODS	Logistic generalized estimating equations ( GEE ) were used to identify predictors of driving cessation ; stratified analysis and interaction terms were used to determine whether factors differed by gender and race .
-RESULTS	Two hundred and five ( 11.5 % ) participants stopped driving over the study period .
-RESULTS	Education was associated with increased risk of cessation for men ( adjusted odds ratio [ AOR ] = 1.40 , 95 % confidence interval [ CI ] = 1.10 to 1.78 ) , but decreased risk for women ( AOR = 0.90 , 95 % CI = 0.82-0 .98 ) .
-RESULTS	Being married was associated with lower risk of cessation for men ( AOR = 0.18 , 95 % CI = 0.06-0 .56 ) but was unrelated to cessation for women ( AOR = 1.00 , 95 % CI = 0.56-1 .80 ) .
-RESULTS	Results were consistent with the hypothesis that racial disparities in cessation widen with increasing age .
-CONCLUSIONS	Factors predictive of driving cessation vary by gender .
-CONCLUSIONS	Racial disparities in cessation are wider at older ages .
-CONCLUSIONS	Transportation policies and programs should account for social determinants and aim to address social disparities in driving mobility among older adults .
-
-###25980660
-OBJECTIVE	Noninvasive ventilation delivered as bilevel positive airway pressure ( BiPAP ) is often used to avoid reintubation and improve outcomes of patients with hypoxemia after cardiothoracic surgery .
-OBJECTIVE	High-flow nasal oxygen therapy is increasingly used to improve oxygenation because of its ease of implementation , tolerance , and clinical effectiveness .
-OBJECTIVE	To determine whether high-flow nasal oxygen therapy was not inferior to BiPAP for preventing or resolving acute respiratory failure after cardiothoracic surgery .
-METHODS	Multicenter , randomized , noninferiority trial ( BiPOP Study ) conducted between June 15 , 2011 , and January 15 , 2014 , at 6 French intensive care units .
-METHODS	A total of 830 patients who had undergone cardiothoracic surgery , of which coronary artery bypass , valvular repair , and pulmonary thromboendarterectomy were the most common , were included when they developed acute respiratory failure ( failure of a spontaneous breathing trial or successful breathing trial but failed extubation ) or were deemed at risk for respiratory failure after extubation due to preexisting risk factors .
-METHODS	Patients were randomly assigned to receive high-flow nasal oxygen therapy delivered continuously through a nasal cannula ( flow , 50 L/min ; fraction of inspired oxygen [ FiO2 ] , 50 % ) ( n = 414 ) or BiPAP delivered with a full-face mask for at least 4 hours per day ( pressure support level , 8 cm H2O ; positive end-expiratory pressure , 4 cm H2O ; FiO2 , 50 % ) ( n = 416 ) .
-METHODS	The primary outcome was treatment failure , defined as reintubation , switch to the other study treatment , or premature treatment discontinuation ( patient request or adverse effects , including gastric distention ) .
-METHODS	Noninferiority of high-flow nasal oxygen therapy would be demonstrated if the lower boundary of the 95 % CI were less than 9 % .
-METHODS	Secondary outcomes included mortality during intensive care unit stay , changes in respiratory variables , and respiratory complications .
-RESULTS	High-flow nasal oxygen therapy was not inferior to BiPAP : the treatment failed in 87 of 414 patients with high-flow nasal oxygen therapy ( 21.0 % ) and 91 of 416 patients with BiPAP ( 21.9 % ) ( absolute difference , 0.9 % ; 95 % CI , -4.9 % to 6.6 % ; P = .003 ) .
-RESULTS	No significant differences were found for intensive care unit mortality ( 23 patients with BiPAP [ 5.5 % ] and 28 with high-flow nasal oxygen therapy [ 6.8 % ] ; P = .66 ) ( absolute difference , 1.2 % [ 95 % CI , -2.3 % to 4.8 % ] .
-RESULTS	Skin breakdown was significantly more common with BiPAP after 24 hours ( 10 % vs 3 % ; 95 % CI , 7.3 % -13.4 % vs 1.8 % -5.6 % ; P < .001 ) .
-CONCLUSIONS	Among cardiothoracic surgery patients with or at risk for respiratory failure , the use of high-flow nasal oxygen therapy compared with intermittent BiPAP did not result in a worse rate of treatment failure .
-CONCLUSIONS	The findings support the use of high-flow nasal oxygen therapy in similar patients .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01458444 .
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-###25880068
-BACKGROUND	Treatment for hypertension with antihypertensive medication has been shown to reduce stroke , cardiovascular events , and mortality in older adults , but there is concern that such treatment may not be appropriate in frailer older adults .
-BACKGROUND	To investigate whether there is an interaction between effect of treatment for hypertension and frailty in older adults , we calculated the frailty index ( FI ) for all available participants from the HYpertension in the Very Elderly Trial ( HYVET ) study , a double-blind , placebo-controlled study of antihypertensives in people with hypertension aged 80 and over , and obtained frailty adjusted estimates of the effect of treatment with antihypertensive medication on risk of stroke , cardiovascular events , and mortality .
-METHODS	Participants in HYVET were randomised 1:1 to active treatment with indapamide sustained release 1.5 mgperindopril 2 to 4mg or to matching placebo .
-METHODS	Data relating to blood pressure , comorbidities , cognitive function , depression , and quality of life were collected at entry into the study and at subsequent follow-up visits .
-METHODS	The FI was calculated at entry , based on 60 potential deficits .
-METHODS	The distribution of FI was similar to that seen in population studies of adults aged 80years and above ( median FI , 0.17 ; IQR , 0.11-0 .24 ) .
-METHODS	Cox regression was used to assess the impact of FI at entry to the study on subsequent risk of stroke , total mortality , and cardiovascular events .
-METHODS	Models were stratified by region of recruitment and adjusted for sex and age at entry .
-METHODS	Extending these models to include a term for a possible interaction between treatment for hypertension and FI provided a formula for the treatment effect as a function of FI .
-METHODS	For all three models , the point estimates of the hazard ratios for the treatment effect decreased as FI increased , although to varying degrees and with varying certainty .
-RESULTS	We found no evidence of an interaction between effect of treatment for hypertension and frailty as measured by the FI .
-RESULTS	Both the frailer and the fitter older adults with hypertension appeared to gain from treatment .
-CONCLUSIONS	Further work to examine whether antihypertensive treatment modifies frailty as measured by the FI should be explored .
-BACKGROUND	ClinicalTrials.gov NCT00122811 ( July 2005 ) .
-
-###24382088
-BACKGROUND	The IAPT services provide high and low intensity psychological treatments for adults suffering from depression and anxiety disorders using a stepped care model .
-BACKGROUND	The latest national evaluation study reported an average recovery rate of 42 % .
-BACKGROUND	However , this figure varied widely between services , with better outcomes associated with higher `` step-up '' rates between low and high intensity treatments .
-OBJECTIVE	This study aimed to compare the two intensity groups in an IAPT service in Suffolk .
-METHODS	This study adopted a between groups design .
-METHODS	A sample of 100 service users was randomly selected from the data collected from an IAPT service in Suffolk between May 2008 and February 2011 .
-METHODS	The treatment outcomes , drop-out rate , and other characteristics were compared between those who received high and low intensity treatments .
-RESULTS	The high intensity group received , on average , more sessions and contact time .
-RESULTS	They received more CBT sessions and less guided self-help .
-RESULTS	There were no group differences in terms of the drop-out and appointment cancellation rates .
-RESULTS	Analyses on clinical outcomes suggested no group difference but demonstrated an overall recovery rate of 52.6 % and significant reduction in both depression and anxiety symptoms .
-CONCLUSIONS	Despite methodological limitations , this study concludes that the service as a whole achieved above-average clinical outcomes .
-CONCLUSIONS	Further research building upon the current study in unpacking the relative strengths and weaknesses for the high and low intensity treatments would be beneficial for service delivery .
-
-###25410607
-BACKGROUND	Falling in older age is a serious and costly problem .
-BACKGROUND	At least one in three older people fall annually .
-BACKGROUND	Although exercise is recognised as an effective fall prevention intervention , low numbers of older people engage in suitable programmes .
-BACKGROUND	Health and exercise professionals play a crucial role in addressing fall risk in older adults .
-BACKGROUND	This trial aims to evaluate the effect of participation in a fall prevention educational programme , compared with a wait-list control group , on health and exercise professionals ' knowledge about fall prevention and the effect on fall prevention exercise prescription behaviour and confidence to prescribe the exercises to older people .
-METHODS	A randomised controlled trial involving 220 consenting health and exercise professionals will be conducted .
-METHODS	Participants will be individually randomised to an intervention group ( n = 110 ) to receive an educational workshop plus access to internet-based support resources , or a wait-list control group ( n = 110 ) .
-METHODS	The two primary outcomes , measured 3months after randomisation , are : ( 1 ) knowledge about fall prevention and ( 2 ) self-perceived change in fall prevention exercise prescription behaviour .
-METHODS	Secondary outcomes include : ( 1 ) participants ' confidence to prescribe fall prevention exercises ; ( 2 ) the proportion of people aged 60 + years seen by trial participants in the past month who were prescribed fall prevention exercise ; and ( 3 ) the proportion of fall prevention exercises prescribed by participants to older people in the past month that comply with evidence-based guidelines .
-METHODS	Outcomes will be measured with a self-report questionnaire designed specifically for the trial .
-BACKGROUND	The trial protocol was approved by the Human Research Ethics Committee , The University of Sydney , Australia .
-BACKGROUND	Trial results will be disseminated via peer reviewed journals , presentations at international conferences and participants ' newsletters .
-BACKGROUND	Trial protocol was registered with the Australian and New Zealand Clinical Trials Registry ( Number ACTRN12614000224628 ) on 3 March 2014 .
-
-###25527255
-BACKGROUND	Diabetes self-management often involves the interpretation and application of oral , written , or quantitative information .
-BACKGROUND	Numerous diabetes patients in China have limited health literacy , which likely leads to poorer clinical outcomes .
-BACKGROUND	This study is designed to examine the efficacy and cost-effectiveness of addressing health literacy to improve self-management skills and glycemic control in Chinese diabetes patients .
-METHODS	This is a cluster randomized controlled trial ( RCT ) conducted in 20 community healthcare sites in Shanghai , China .
-METHODS	Overall , 800 diabetes patients will be randomized into intervention and control arms and will have a baseline hemoglobin A1c ( HbA1c ) assay and undergo a baseline survey which includes measures of health literacy and diabetes numeracy using revised Chinese versions of the Health Literacy Management Scale and Diabetes Numeracy Test Scale .
-METHODS	During the 1-year period of intervention , while the control group will receive usual care , the intervention group will be supplemented with a comprehensive health literacy strategy which includes i ) training healthcare providers in effective health communication skills that address issues related to low literacy , and ii ) use of an interactive Diabetes Education Toolkit to improve patient understanding and behaviors .
-METHODS	Assessments will be conducted at both patient and healthcare provider levels , and will take place upon admission and after 3 , 6 , 12 , and 24 months of intervention .
-METHODS	The primary outcome will be the improvement in HbA1c between Intervention group and Control group patients .
-METHODS	Secondary outcomes at the patient level will include improvement in i ) clinical outcomes ( blood pressure , fasting lipids , body mass index , weight , smoking status ) , ii ) patient reported self-management behaviors , and iii ) patient-reported self-efficacy .
-METHODS	Outcomes at the provider level will include : i ) provider satisfaction and ii ) intensity and type of care provided .
-METHODS	The effects of the intervention will be examined in multivariable general linear models .
-METHODS	Both cost-effectiveness and cost-utility analyses will be performed .
-CONCLUSIONS	The main strengths of this study are its large sample size and RCT design , involvement of both patients and healthcare providers , and the long term follow-up ( 24-months ) .
-CONCLUSIONS	This project will help to demonstrate the value of addressing health literacy and health communication to improve self-management and clinical outcomes among Chinese diabetes patients .
-BACKGROUND	ISRCTN76130594 , Registration date : Sept 22 , 2014 .
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-###25248446
-BACKGROUND	The patients with brain lesion have a high risk of pulmonary complication due to restrictive pulmonary impairment .
-OBJECTIVE	To investigate the effectiveness of active pulmonary rehabilitation on pulmonary functional improvement in these patients .
-METHODS	Twnety-two patients of hemiplegia or quadriplegia with brain lesion were recruited who had restrictive pulmonary impairment .
-METHODS	The patients were randomly assigned to an experimental group that receive active pulmonary rehabilitation training and a control group without it .
-METHODS	The active pulmonary rehabilitation training is composed of air-stacking exercise by ambu-bagging and functional electrical stimulation ( FES ) on phrenic nerve and abdominal muscle .
-METHODS	We examined respiration function test of all patients composed of peak cough flow ( PCF ) , pulmonary function test ( PFT ) , diaphragmatic motion evaluation and oxygen saturation ( SaO2 ) at the beginning and 4 weeks after treatment .
-RESULTS	There was no significant difference in pulmonary function between experimental group and control group at the beginning .
-RESULTS	After 4 weeks treatment , FVC and FEV1 of PFT , PCF , diaphragmatic motion , SaO2 have significantly improved ( p < 0.05 ) in experimental group , but no significant changes were detected in control group .
-CONCLUSIONS	It is suggested that active pulmonary rehabilitation with air-stacking exercise and FES would be useful to improve pulmonary function in patients with brain lesion .
-
-###25308309
-OBJECTIVE	The observation of movements increases primary motor cortex ( M1 ) excitability .
-OBJECTIVE	This exploratory study examined the effects of movement observation on pressure pain threshold ( PPT ) and transcranial magnetic stimulation ( TMS ) - indexed corticospinal excitability bilaterally .
-METHODS	Thirty healthy right-handed subjects were randomized to a left hand-movement observation task or a control task .
-METHODS	Statistical analyses were performed using ANOVA models and t-tests .
-METHODS	Results were not corrected for multiple comparisons .
-METHODS	Quantitative sensory assessments were measured in both hands , while M1 excitability has only been tested for the right ( non-dominant ) M1 corresponding to the observed left hand movements .
-RESULTS	Analysis of pain and cortical silent period ( CSP ) outcomes demonstrated a significant interaction between task ( hand-movement group ) versus control group and time ( pre - / postintervention ) .
-RESULTS	PPT increased in the left hand ( moving hand in the task ) and declined significantly in the contralateral hand ( still hand ) in the movement-observation-task-group , whereas PTT in the control group remained unchanged .
-RESULTS	CSP was significantly shorter in the movement-observation group indicating decreased intracortical inhibition ( results uncorrected for multiple comparisons ) .
-CONCLUSIONS	The observation of hand-movements led to a side-specific reduction in pain perception and a decrease in intracortical inhibition .
-CONCLUSIONS	These exploratory findings support the notion that M1 is a robust modulator of pain-related neural networks .
-CONCLUSIONS	This effect might be mediated through modulation of the GABAergic system and appears to differ from what is observed in chronic pain .
-
-###25146059
-BACKGROUND	This study explored the effects of acupressure on fatigue of lung cancer patients undergoing chemotherapy .
-METHODS	For this experimental study , 57 subjects were randomly assigned to three groups : acupressure with essential oils ( n = 17 ) , acupressure only ( n = 24 ) , and sham acupressure ( n = 16 ) .
-METHODS	Acupoints were Hegu ( LI4 ) , Zusanli ( ST36 ) , and Sanyingjiao ( SP6 ) .
-METHODS	All subjects received acupressure once every morning for 5 months , with each acupoint pressed for 1 min .
-METHODS	Fatigue , functional status , anxiety , depression , and sleep quality were measured before initial chemotherapy ( T0 ) , on Day 1 of third chemotherapy ( T1 ) , and on Day 1 of sixth chemotherapy ( T2 ) .
-METHODS	Outcome differences between groups were analyzed at T0 , T1 , and T2 by general estimating equations .
-RESULTS	After controlling for baseline outcome values , age , and adherence to acupressure , subjects who received acupressure with essential oils and acupressure had significantly less fatigue in daily living activities and sleep better quality at T1 than subjects who received sham acupressure .
-RESULTS	Subjects who received acupressure with essential oils had significantly better sleep quality at T2 than the sham acupressure group .
-RESULTS	Subjects who received acupressure with or without essential oils had greater odds of better functional status at T1 than the sham group .
-CONCLUSIONS	It is plausible that acupressure with or without essential oils helps lung cancer patients undergoing chemotherapy reduce cancer-related fatigue and increase activity level .
-CONCLUSIONS	Further study is wanted to test this hypothesis .
-
-###24901838
-OBJECTIVE	`` Outlet obstruction '' is a complex functional disorder compelling patients to exhausting uneffective attempts to void .
-OBJECTIVE	This study was designed to compare the effectiveness and a safety of the endorectal proctopexy ( internal Delorme ) vs STARR procedure in two groups of patients .
-METHODS	A total of 66 patients with rectocele and associated mucosal prolapse or anorectal intussusception between January 2006 and June 2010 were randomly assigned to Group # 1 Endorectal proctopexy with levatorplasty ( ERPP ) and Group # 2 STARR .
-METHODS	Patients were assessed one week , six and twelve months after the operation .
-METHODS	Operative time , postoperative pain , day of discharge and late complications was recorded .
-METHODS	The time of recovery of work was also assessed .
-METHODS	The continence score was updated with a constipation questionnaire .
-METHODS	Quality of life after the operation and the overall grade of satisfaction were assessed and compared with radiological findings .
-METHODS	All patients were reassessed after one year .
-RESULTS	The results in the two groups of patients show no significant difference between ERPP and STARR : the improvement in symptoms is similar but significant and well definite in both groups with a low incidence of postoperative complications .
-RESULTS	STARR procedure is just faster to perform even if more expensive .
-RESULTS	Dyspareunia slightly improved mainly in ERPP group , due probably to scar distention .
-CONCLUSIONS	The results of our experience indicate a significant improvement of symptoms with both techniques .
-CONCLUSIONS	The overall incidence rate of postoperative complications is low and similar between the two groups .
-CONCLUSIONS	As economical consideration , ERPP is less expensive .
-
-###26008626
-OBJECTIVE	To study the effect of different protocols of collagen cross-linking on visual , refractive , and tomographic parameters in patients with progressive keratoconus .
-METHODS	Prospective randomized interventional study .
-METHODS	In this study , 138 eyes of 138 patients with progressive keratoconus underwent corneal collagen cross-linking ( CXL ) .
-METHODS	Following detailed preoperative examination , Group I underwent conventional cross-linking ( 36 patients , 3 mW/cm ( 2 ) for 30 min ) ; Group II ( 36 patients , 9 mW/cm ( 2 ) for 10 min ) , Group III ( 33 patients , 18 mW/cm ( 2 ) for 5 min ) , and Group IV ( 33 patients , 30 mW/cm ( 2 ) for 3 min ) underwent accelerated cross-linking .
-METHODS	Changes in corrected distance visual acuity ( CDVA ) , spherical equivalent ( SE ) , flat keratometry , steep keratometry , thinnest pachymetry , specular microscopy , and demarcation line were studied at 6 and 12 months .
-RESULTS	Improvement in the mean CDVA and SE were statistically significant in all groups except Group IV ( P = .15 at 6 months , P = .17 at 12 months ) , with Group III ( P = .01 at 6 and 12 months ) showing the best results .
-RESULTS	Flattening of steep and flat keratometry was significant in Groups I ( P = .01 ) and II ( P = .01 ) as compared to the other groups .
-RESULTS	There was no significant difference in the pachymetry or specular microscopy in any of the groups .
-RESULTS	Groups I and II demonstrated a good demarcation line when compared to other groups .
-CONCLUSIONS	Conventional CXL ( Group I ) and accelerated CXL with irradiations of 9 mW/cm ( 2 ) ( Group II ) and 18 mW/cm ( 2 ) ( Group III ) showed better visual , refractive , and tomographic improvements at the end of 12 months .
-
-###25072937
-BACKGROUND	Arginase competes with nitric oxide synthase for their common substrate L-arginine .
-BACKGROUND	Up-regulation of arginase in coronary artery disease ( CAD ) and diabetes mellitus may reduce nitric oxide bioavailability contributing to endothelial dysfunction and ischemia-reperfusion injury .
-BACKGROUND	Arginase inhibition reduces infarct size in animal models .
-BACKGROUND	Therefore the aim of the current study was to investigate if arginase inhibition protects from endothelial dysfunction induced by ischemia-reperfusion in patients with CAD with or without type 2 diabetes (
-BACKGROUND	NCT02009527 ) .
-METHODS	Male patients with CAD ( n = 12 ) or CAD + type 2 diabetes ( n = 12 ) , were included in this cross-over study with blinded evaluation .
-METHODS	Endothelium-dependent vasodilatation was assessed by flow-mediated dilatation ( FMD ) of the radial artery before and after 20 min ischemia-reperfusion during intra-arterial infusion of the arginase inhibitor ( N-hydroxy-nor-L-arginine , 0.1 mg/min ) or saline .
-RESULTS	The forearm ischemia-reperfusion was well tolerated .
-RESULTS	Endothelium-independent vasodilatation was assessed by sublingual nitroglycerin .
-RESULTS	Ischemia-reperfusion decreased FMD in patients with CAD from 12.75.2 % to 7.94.0 % during saline administration ( P < 0.05 ) .
-RESULTS	N-hydroxy-nor-L-arginine administration prevented the decrease in FMD in the CAD group ( 10.34.3 % at baseline vs. 11.53.6 % at reperfusion ) .
-RESULTS	Ischemia-reperfusion did not significantly reduce FMD in patients with CAD + type 2 diabetes .
-RESULTS	However , FMD at reperfusion was higher following nor-NOHA than following saline administration in both groups ( P < 0.01 ) .
-RESULTS	Endothelium-independent vasodilatation did not differ between the occasions .
-CONCLUSIONS	Inhibition of arginase protects against endothelial dysfunction caused by ischemia-reperfusion in patients with CAD .
-CONCLUSIONS	Arginase inhibition may thereby be a promising therapeutic strategy in the treatment of ischemia-reperfusion injury .
-
-###24930639
-OBJECTIVE	To evaluate the clinical and microbiological effects of the use of metronidazole ( MTZ ) + amoxicillin ( AMX ) as adjuncts to scaling and root planing ( SRP ) for the treatment of chronic periodontitis ( ChP ) in type 2 diabetic subjects .
-METHODS	Fifty-eight type 2 diabetic subjects ( n = 29/group ) with generalized ChP were randomly assigned to receive SRP alone or with MTZ [ 400mg/thrice a day ( TID ) ] + AMX ( 500mg/TID ) for 14days .
-METHODS	Subgingival biofilm samples were analyzed by qPCR for the presence of seven periodontal pathogens .
-METHODS	Subjects were monitored at baseline , 3 , 6 and 12months post-therapies .
-RESULTS	The group receiving SRP+MTZ+AMX presented greater mean probing depth ( PD ) reduction and clinical attachment gain , a lower number of sites with PD 5mm ( primary outcome variable ) and a reduced number of subjects with 9 of these residual pockets than the control group at 1-year post-therapy ( p < 0.05 ) .
-RESULTS	The antibiotic-treated group also presented reduced levels and greater decreases of the three red complex species , Eubacterium nodatum and Prevotella intermedia , compared to the control group at 1year ( p < 0.05 ) .
-CONCLUSIONS	The adjunctive use of MTZ+AMX significantly improved the clinical and microbiological outcomes of SRP in the treatment of type 2 diabetic subjects with ChP .
-
-###24245844
-OBJECTIVE	To evaluate an intervention based on implementation intention principles designed to increase uptake of colorectal cancer screening , and to examine differential efficacy by socioeconomic deprivation .
-METHODS	In England , adults aged between 60 and 69 years are invited for biennial fecal occult blood testing .
-METHODS	A test kit and an information leaflet are mailed to each individual by the `` Hubs '' that deliver the national screening program .
-METHODS	In the intervention group , three preformulated implementation intentions , based on known barriers to carrying out the test , were added to the information leaflet .
-METHODS	Over a 12-week period , each week was randomly allocated to either the intervention ( n = 12,414 invitations ) or the control condition ( n = 10,768 ) , with uptake recorded at the Hub .
-METHODS	Socioeconomic deprivation of each individual 's area of residence was categorized into tertiles .
-RESULTS	There was no overall difference in uptake between control ( 40.4 % ) and intervention ( 39.7 % ) conditions , odds ratio ( OR ) = 0.97 , 95 % confidence interval ( CI ) [ 0.91 , 1.04 ] .
-RESULTS	There was an interaction with deprivation , OR = 1.11 , 95 % CI [ 1.04 , 1.18 ] , but the positive effect observed in the lowest socioeconomic status ( SES ) tertile was small ( 35.2 % vs. 33.0 % ) , OR = 1.103 , 95 % CI [ 1.01 , 1.21 ] , and offset by a negative effect in the least deprived tertile ( 45.6 % vs. 48.2 % ) , OR = 0.90 , 95 % CI [ 0.82 , 0.99 ] .
-RESULTS	The intervention had no significant effect in the middle tertile ( 38.9 % vs. 40.8 % ) , OR = 0.92 , 95 % CI [ 0.81 , 1.04 ] .
-CONCLUSIONS	Preformulated implementation intentions did not increase overall colorectal cancer screening uptake and failed to make a sufficiently large impact on uptake among lower SES groups to merit their future use in this context .
-
-###25209738
-BACKGROUND	Duchenne muscular dystrophy is caused by dystrophin deficiency and muscle deterioration and preferentially affects boys .
-BACKGROUND	Antisense-oligonucleotide-induced exon skipping allows synthesis of partially functional dystrophin .
-BACKGROUND	We investigated the efficacy and safety of drisapersen , a 2 ' - O-methyl-phosphorothioate antisense oligonucleotide , given for 48 weeks .
-METHODS	In this exploratory , double-blind , placebo-controlled study we recruited male patients ( 5 years of age ; time to rise from floor 7 s ) with Duchenne muscular dystrophy from 13 specialist centres in nine countries between Sept 1 , 2010 , and Sept 12 , 2012 .
-METHODS	By use of a computer-generated randomisation sequence , we randomly allocated patients ( 2:2:1:1 ; block size of six ; no stratification ) to drisapersen 6 mg/kg or placebo , each given subcutaneously and either continuously ( once weekly ) or intermittently ( nine doses over 10 weeks ) .
-METHODS	The primary endpoint was change in 6-min walk distance ( 6MWD ) at week 25 in patients in the intention-to-treat population for whom data were available .
-METHODS	Safety assessments included renal , hepatic , and haematological monitoring and recording of adverse events .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT01153932 .
-RESULTS	We recruited 53 patients : 18 were given continuous drisapersen , 17 were given intermittent drisapersen , and 18 were given placebo ( continuous and intermittent groups combined ) .
-RESULTS	At week 25 , mean 6MWD had increased by 315 m ( SE 98 ) from baseline for continuous drisapersen , with a mean difference in change from baseline of 3509 m ( 95 % CI 759 to 6260 ; p = 0014 ) versus placebo .
-RESULTS	We recorded no difference in 6MWD changes from baseline between intermittent drisapersen ( mean change -01 [ SE 103 ] ) and placebo ( mean difference 351 m [ -2434 to 3135 ] ) at week 25 .
-RESULTS	The most common adverse events in drisapersen-treated patients were injection-site reactions ( 14 patients given continuous drisapersen , 15 patients given intermittent drisapersen , and six given placebo ) and renal events ( 13 for continuous drisapersen , 12 for intermittent drisapersen , and seven for placebo ) , most of which were subclinical proteinuria .
-RESULTS	None of the serious adverse events reported ( one for continuous , two for intermittent , and two for placebo ) resulted in withdrawal from the study .
-CONCLUSIONS	Continuous drisapersen resulted in some benefit in 6MWD versus placebo at week 25 .
-CONCLUSIONS	The safety findings are similar to those from previous studies .
-CONCLUSIONS	Ambulation improvements in this young population with early-stage Duchenne muscular dystrophy are encouraging but need to be confirmed in larger studies .
-BACKGROUND	GlaxoSmithKline , Prosensa Therapeutics BV ( a subsidiary of Prosensa Holding NV ) .
-
-###24569536
-OBJECTIVE	Evidence from animal and in vitro models suggest a role of probiotic bacteria in improving glycaemic control and delaying the onset of type 2 diabetes .
-OBJECTIVE	However , the evidence from controlled trials in humans is limited .
-OBJECTIVE	The objective was to determine if the probiotic bacteria L. acidophilus La5 and B. animalis subsp lactis Bb12 , supplemented in a whole food ( yoghurt ) or isolated ( capsules ) form , can improve biomarkers of glycaemic control .
-METHODS	Following a 3-week washout period , 156 overweight men and women over 55 years ( mean age : 67 8 years ; mean body mass index ( 31 4 kg/m ( 2 ) ) were randomized to a 6-week double-blinded parallel study .
-METHODS	The four intervention groups were : ( A ) probiotic yoghurt plus probiotic capsules ; ( B ) probiotic yoghurt plus placebo capsules ; ( C ) control milk plus probiotic capsules ; and ( D ) control milk plus placebo capsules .
-METHODS	Outcome measurements , including fasting glucose , insulin , glycated haemoglobin and Homoeostasis Model Assessment of Insulin Resistance ( HOMA-IR ) , were performed at baseline and week 6 .
-RESULTS	Relative to the milk-control group , probiotic yoghurt resulted in a significantly higher HOMA-IR ( 0.32 0.15 , P = 0.038 ) , but did not have a significant effect on the other three measures of glycaemic control ( P > 0.05 ) .
-RESULTS	Relative to placebo capsules , probiotic capsules resulted in a significantly higher fasting glucose ( 0.15 0.07 mmol/l , P = 0.037 ) , with no significant effect on the other three measures of glycaemic control ( P > 0.05 ) .
-RESULTS	Further analyses did not identify other variables as contributing to these adverse findings .
-CONCLUSIONS	Data from this study does not support the hypothesis that L. acidophilus La5 and B. animalis subsp lactis Bb12 , either in isolated form or as part of a whole food , benefit short-term glycaemic control .
-CONCLUSIONS	Indeed , there is weak data for an adverse effect of these strains on glucose homoeostasis .
-
-###25660917
-BACKGROUND	People who are physically active have at least a 30 % lower risk of death during follow-up compared with those who are inactive .
-BACKGROUND	However , the ideal dose of exercise for improving longevity is uncertain .
-OBJECTIVE	The aim of this study was to investigate the association between jogging and long-term , all-cause mortality by focusing specifically on the effects of pace , quantity , and frequency of jogging .
-METHODS	As part of the Copenhagen City Heart Study , 1,098 healthy joggers and 3,950 healthy nonjoggers have been prospectively followed up since 2001 .
-METHODS	Cox proportional hazards regression analysis was performed with age as the underlying time scale and delayed entry .
-RESULTS	Compared with sedentary nonjoggers , 1 to 2.4 h of jogging per week was associated with the lowest mortality ( multivariable hazard ratio [ HR ] : 0.29 ; 95 % confidence interval [ CI ] : 0.11 to 0.80 ) .
-RESULTS	The optimal frequency of jogging was 2 to 3 times per week ( HR : 0.32 ; 95 % CI : 0.15 to 0.69 ) or 1 time per week ( HR : 0.29 ; 95 % CI : 0.12 to 0.72 ) .
-RESULTS	The optimal pace was slow ( HR : 0.51 ; 95 % CI : 0.24 to 1.10 ) or average ( HR : 0.38 ; 95 % CI : 0.22 to 0.66 ) .
-RESULTS	The joggers were divided into light , moderate , and strenuous joggers .
-RESULTS	The lowest HR for mortality was found in light joggers ( HR : 0.22 ; 95 % CI : 0.10 to 0.47 ) , followed by moderate joggers ( HR : 0.66 ; 95 % CI : 0.32 to 1.38 ) and strenuous joggers ( HR : 1.97 ; 95 % CI : 0.48 to 8.14 ) .
-CONCLUSIONS	The findings suggest a U-shaped association between all-cause mortality and dose of jogging as calibrated by pace , quantity , and frequency of jogging .
-CONCLUSIONS	Light and moderate joggers have lower mortality than sedentary nonjoggers , whereas strenuous joggers have a mortality rate not statistically different from that of the sedentary group .
-
-###25158846
-BACKGROUND	In August 2010 , the Federal Joint Committee ( G-BA ) decided that negative pressure wound therapy ( NPWT ) would not be reimbursable in German ambulatory care .
-BACKGROUND	This decision was based on reports from the Institute for Quality and Efficiency in Health Care ( IQWiG ) , which concluded that there is no convincing evidence in favor of NPWT .
-BACKGROUND	The aim of this diabetic foot study ( DiaFu study ) is to evaluate whether the clinical , safety and economic results of NPWT are superior to the results of standard wound treatment .
-METHODS	The DiaFu study is designed as a national , multicenter , randomized controlled clinical superiority trial with a special focus on outpatient care in Germany .
-METHODS	Competent patients in inpatient and outpatient care suffering from a chronic diabetic foot wound for a minimum of four weeks may be included in the study .
-METHODS	The trial evaluates the treatment outcome of the application of a technical medical device which is based on the principle of NPWT ( intervention group ) in comparison to standard moist wound therapy ( control group ) .
-METHODS	All treatment systems used in the intervention group bear the symbol of free trade capacity in the European Union ( CE mark ) and will be operated within normal conditions of clinical routine and according to manufacturer 's instructions .
-METHODS	Primary endpoints are the time to complete wound healing and the rate of wound healing achieved in each group within the maximum study treatment time of 16weeks .
-METHODS	Primary endpoints will be confirmed by blinded assessment of wound photographs .
-CONCLUSIONS	The DiaFu study will provide solid evidence regarding the efficacy and effectiveness of NPWT until 31 December 2014 , the date when G-BA plans to decide on future reimbursement of NPWT in both ambulatory and in-hospital care .
-CONCLUSIONS	The study is designed to comply with all quality requirements of G-BA and IQWiG and will contribute to evidence-based wound care in Germany .
-CONCLUSIONS	The study has been initiated by the statutory health insurance companies in Germany and is co-funded by two manufacturers of NPWT systems .
-BACKGROUND	Clinical Trials.gov registration number : NCT01480362 ( date of registration : 23 November 2011 ) .
-BACKGROUND	German Clinical Trials Register number : DRKS00003347 ( date of registration : 22 November 2011 ) .
-
-###25038356
-OBJECTIVE	Self-testing for HIV infection may contribute to early diagnosis of HIV , but without necessarily increasing antiretroviral therapy ( ART ) initiation .
-OBJECTIVE	To investigate whether offering optional home initiation of HIV care after HIV self-testing might increase demand for ART initiation , compared with HIV self-testing accompanied by facility-based services only .
-METHODS	Cluster randomized trial conducted in Blantyre , Malawi , between January 30 and November 5 , 2012 , using restricted 1:1 randomization of 14 community health worker catchment areas .
-METHODS	Participants were all adult ( 16 years ) residents ( n = 16,660 ) who received access to home HIV self-testing through resident volunteers .
-METHODS	This was a second-stage randomization of clusters allocated to the HIV self-testing group of a parent trial .
-METHODS	Clusters were randomly allocated to facility-based care or optional home initiation of HIV care ( including 2 weeks of ART if eligible ) for participants reporting positive HIV self-test results .
-METHODS	The preplanned primary outcome compared between groups the proportion of all adult residents who initiated ART within the first 6 months of HIV self-testing availability .
-METHODS	Secondary outcomes were uptake of HIV self-testing , reporting of positive HIV self-test results , and rates of loss from ART at 6 months .
-RESULTS	A significantly greater proportion of adults in the home group initiated ART ( 181/8194 , 2.2 % ) compared with the facility group ( 63/8466 , 0.7 % ; risk ratio [ RR ] , 2.94 , 95 % CI , 2.10-4 .12 ; P < .001 ) .
-RESULTS	Uptake of HIV self-testing was high in both the home ( 5287/8194 , 64.9 % ) and facility groups ( 4433/8466 , 52.7 % ; RR , 1.23 ; 95 % CI , 0.96-1 .58 ; P = .10 ) .
-RESULTS	Significantly more adults reported positive HIV self-test results in the home group ( 490/8194 [ 6.0 % ] vs the facility group , 278/8466 [ 3.3 % ] ; RR , 1.86 ; 95 % CI , 1.16-2 .97 ; P = .006 ) .
-RESULTS	After 6 months , 52 of 181 ART initiators ( 28.7 % ) and 15 of 63 ART initiators ( 23.8 % ) in the home and facility groups , respectively , were lost from ART ( adjusted incidence rate ratio , 1.18 ; 95 % CI , 0.62-2 .25 , P = .57 ) .
-CONCLUSIONS	Among Malawian adults offered HIV self-testing , optional home initiation of care compared with standard HIV care resulted in a significant increase in the proportion of adults initiating ART .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01414413 .
-
-###25122422
-BACKGROUND	Fluorescence in situ hybridization ( FISH ) is currently the standard for diagnosing anaplastic lymphoma kinase ( ALK ) - rearranged ( ALK + ) lung cancers for ALK inhibitor therapies .
-BACKGROUND	ALK immunohistochemistry ( IHC ) may serve as a screening and alternative diagnostic method .
-BACKGROUND	The Canadian ALK ( CALK ) study was initiated to implement a multicenter optimization and standardization of laboratory developed ALK IHC and FISH tests across 14 hospitals .
-METHODS	Twenty-eight lung adenocarcinomas with known ALK status were used as blinded study samples .
-METHODS	Thirteen laboratories performed IHC using locally developed staining protocols for 5A4 , ALK1 , or D5F3 antibodies ; results were assessed by H-score .
-METHODS	Twelve centers conducted FISH using protocols based on Vysis ' ALK break-apart FISH kit .
-METHODS	Initial IHC results were used to optimize local IHC protocols , followed by a repeat IHC study to assess the results of standardization .
-METHODS	Three laboratories conducted a prospective parallel IHC and FISH analysis on 411 consecutive clinical samples using post-validation optimized assays .
-RESULTS	Among study samples , FISH demonstrated 22 consensus ALK + and six ALK wild type tumors .
-RESULTS	Preoptimization IHC scores from 12 centers with 5A4 and the percent abnormal cells by FISH from 12 centers showed intraclass correlation coefficients of 0.83 and 0.68 , respectively .
-RESULTS	IHC optimization improved the intraclass correlation coefficients to 0.94 .
-RESULTS	Factors affecting FISH scoring and outliers were identified .
-RESULTS	Post-optimization concurrent IHC/FISH testing in 373 informative cases revealed 100 % sensitivity and specificity for IHC versus FISH .
-CONCLUSIONS	Multicenter standardization study may accelerate the implementation of ALK testing protocols across a country/region .
-CONCLUSIONS	Our data support the use of an appropriately validated IHC assay to screen for ALK + lung cancers .
-
-###25033900
-OBJECTIVE	To evaluate the changes in corneal sensation ( CS ) following two different port sizes vitrectomy in diabetic and non-diabetic patients .
-METHODS	Patients prepared for pars plana vitrectomy were randomly assigned to four groups : diabetics to either 20G or 23G and non-diabetics to either 20G or 23G vitrectomy systems .
-METHODS	CS was measured using the Cochet-Bonnet aesthesiometer at baseline preoperatively , and at 1 day , 1 week , and 1 month postoperative .
-RESULTS	A total of 40 eyes of 40 patients were included in this study ; 20 patients ( 20 eyes ) in each of the 20-G and 23-G groups .
-RESULTS	The mean age was 55.5110 years and male/female ratio was 2:3 .
-RESULTS	There were no significant difference between CS at baseline , and at 1 day , 1 week , and 1 month between both the 20-G and 23-G groups .
-RESULTS	There were significant drops in CSs at 1 day and 1 week for both groups ( 20G and 23G ) with incomplete recovery for the 20-G group and complete recovery for the 23-G group .
-RESULTS	Comparing the two diabetic subgroups ( 20G and 23G ) and two non-diabetic subgroups ( 20G and 23G ) , there were no significant differences in CS between subgroups .
-RESULTS	Diabetics ' eyes had lower CSs throughout the study period in the 20-G and 23-G groups , which was significant at day1 and week 1 postoperatively .
-CONCLUSIONS	The vitrectomy procedure showed reduction in CS in the postoperative period with minimal nonsignificant difference between 20G and 23G systems .
-CONCLUSIONS	However , diabetics ' eyes showed compromised CS preoperatively and a further significant reduction for 1 month postoperatively compared with non-diabetics .
-
-###24838215
-OBJECTIVE	Steady-state visually evoked potential ( SSVEP ) - based brain-computer interfaces ( BCIs ) allow healthy subjects to communicate .
-OBJECTIVE	However , their dependence on gaze control prevents their use with severely disabled patients .
-OBJECTIVE	Gaze-independent SSVEP-BCIs have been designed but have shown a drop in accuracy and have not been tested in brain-injured patients .
-OBJECTIVE	In the present paper , we propose a novel independent SSVEP-BCI based on covert attention with an improved classification rate .
-OBJECTIVE	We study the influence of feature extraction algorithms and the number of harmonics .
-OBJECTIVE	Finally , we test online communication on healthy volunteers and patients with locked-in syndrome ( LIS ) .
-METHODS	Twenty-four healthy subjects and six LIS patients participated in this study .
-METHODS	An independent covert two-class SSVEP paradigm was used with a newly developed portable light emitting diode-based ` interlaced squares ' stimulation pattern .
-RESULTS	Mean offline and online accuracies on healthy subjects were respectively 85 2 % and 74 13 % , with eight out of twelve subjects succeeding to communicate efficiently with 80 9 % accuracy .
-RESULTS	Two out of six LIS patients reached an offline accuracy above the chance level , illustrating a response to a command .
-RESULTS	One out of four LIS patients could communicate online .
-CONCLUSIONS	We have demonstrated the feasibility of online communication with a covert SSVEP paradigm that is truly independent of all neuromuscular functions .
-CONCLUSIONS	The potential clinical use of the presented BCI system as a diagnostic ( i.e. , detecting command-following ) and communication tool for severely brain-injured patients will need to be further explored .
-
-###24615500
-BACKGROUND	In the BOLERO-2 trial , everolimus ( EVE ) , an inhibitor of mammalian target of rapamycin , demonstrated significant clinical benefit with an acceptable safety profile when administered with exemestane ( EXE ) in postmenopausal women with hormone receptor-positive ( HR ( + ) ) advanced breast cancer .
-BACKGROUND	We report on the incidence , time course , severity , and resolution of treatment-emergent adverse events ( AEs ) as well as incidence of dose modifications during the extended follow-up of this study .
-METHODS	Patients were randomized ( 2:1 ) to receive EVE 10 mg/day or placebo ( PBO ) , with open-label EXE 25 mg/day ( n = 724 ) .
-METHODS	The primary end point was progression-free survival .
-METHODS	Secondary end points included overall survival , objective response rate , and safety .
-METHODS	Safety evaluations included recording of AEs , laboratory values , dose interruptions/adjustments , and study drug discontinuations .
-RESULTS	The safety population comprised 720 patients ( EVE + EXE , 482 ; PBO + EXE , 238 ) .
-RESULTS	The median follow-up was 18 months .
-RESULTS	Class-effect toxicities , including stomatitis , pneumonitis , and hyperglycemia , were generally of mild or moderate severity and occurred relatively early after treatment initiation ( except pneumonitis ) ; incidence tapered off thereafter .
-RESULTS	EVE dose reduction and interruption ( 360 and 705 events , respectively ) required for AE management were independent of patient age .
-RESULTS	The median duration of dose interruption was 7 days .
-RESULTS	Discontinuation of both study drugs because of AEs was higher with EVE + EXE ( 9 % ) versus PBO + EXE ( 3 % ) .
-CONCLUSIONS	Most EVE-associated AEs occur soon after initiation of therapy , are typically of mild or moderate severity , and are generally manageable with dose reduction and interruption .
-CONCLUSIONS	Discontinuation due to toxicity was uncommon .
-CONCLUSIONS	Understanding the time course of class-effect AEs will help inform preventive and monitoring strategies as well as patient education .
-BACKGROUND	NCT00863655 .
-
-###25526678
-OBJECTIVE	The retrospective comparison of test and reference treatment arms in a randomized prospective clinical trial is potentially useful in economic modeling seeking to assess the cost effectiveness of alternative therapies .
-METHODS	To enhance the credibility of such retrospective comparisons , we propose the application of the following adjustments to significance levels obtained from standard statistical methodology : ( 1 ) a significance test for the lower bound of the 95 % confidence interval for the observed difference , ( 2 ) a conservative Bonferroni method of adjustment for multiple comparisons , ( 3 ) an adjusted p-value calculated using Scheffe 's single-step method , and ( 4 ) Bayesian 95 % credibility intervals with a prior centered at zero .
-RESULTS	These adjustments were applied to data from a randomized double-blind concurrent trial ( SPD489-325 ) that established the efficacy and safety of lisdexamfetamine dimesylate ( LDX ) in children and adolescents with attention-deficit/hyperactivity disorder ( ADHD ) .
-RESULTS	Prospectively planned analyses demonstrated that the reduction in the symptoms of ADHD was significantly greater than placebo in patients treated with either LDX or the reference treatment , osmotic-release oral system methylphenidate ( OROS-MPH ) .
-RESULTS	Retrospective analyses showed that the improvement in the symptoms of ADHD was greater in patients treated with LDX than OROS-MPH .
-RESULTS	We now show that this observation remained significant after the application of the four statistical penalties .
-CONCLUSIONS	By adjusting the significance level , it is possible to compare quantitatively such retrospective results with prospectively defined comparisons .
-CONCLUSIONS	However , the qualitative level of such retrospective evidence should remain secondary to that obtained from prospectively specified comparisons in a randomized clinical trial .
-
-###25304446
-BACKGROUND	Alzheimer 's disease is characterised by a loss of cognitive function and behavioural problems as set out in the term `` Behavioural and Psychological Symptoms of Dementia '' .
-BACKGROUND	These behavioural symptoms have heavy consequences for the patients and their families .
-BACKGROUND	A greater understanding of behavioural symptoms risk factors would allow better detection of those patients , a better understanding of crisis situations and better management of these patients .
-BACKGROUND	Some retrospective studies or simple observations suggested that personality could play a role in the occurrence of behavioural symptoms .
-BACKGROUND	Finally , performance in social cognition like facial recognition and perspective taking could be linked to certain personality traits and the subsequent risks of behavioural symptoms .
-BACKGROUND	We propose to clarify this through a prospective , multicentre , multidisciplinary study .
-BACKGROUND	Main Objective : - To assess the effect of personality and life events on the risk of developing behavioural symptoms .
-BACKGROUND	Secondary Objectives : - To evaluate , at the time of inclusion , the connection between personality and performance in social cognition tests ; - To evaluate the correlation between performance in social cognition at inclusion and the risks of occurrence of behavioural symptoms ; - To evaluate the correlation between regional cerebral atrophy , using brain Magnetic Resonance Imaging at baseline , and the risk of behavioural symptoms .
-METHODS	Study type and Population : Prospective multicentre cohort study with 252 patients with Alzheimer 's disease at prodromal or mild dementia stage .
-METHODS	The inclusion period will be of 18 months and the patients will be followed during 18 months .
-METHODS	The initial evaluation will include : a clinical and neuropsychological examination , collection of behavioural symptoms data ( Neuropsychiatric-Inventory scale ) and their risk factors , a personality study using both a dimensional ( personality traits ) and categorical approach , an inventory of life events , social cognition tests and an Magnetic Resonance Imaging .
-METHODS	Patients will be followed every 6 months ( clinical examination and collection of behavioural symptoms data and risk factors ) during 18 months .
-CONCLUSIONS	This study aims at better identifying the patients with Alzheimer 's disease at high risk of developing behavioural symptoms , to anticipate , detect and quickly treat these disorders and so , prevent serious consequences for the patient and his caregivers .
-BACKGROUND	ClincalTrials.gov : NCT01297140 .
-
-###26062183
-OBJECTIVE	To explore the effective therapeutic method for reducing adductor muscle tension in the children of spasmodic cerebral palsy .
-METHODS	One hundred and forty cases of spasmodic cerebral palsy met the inclusive criteria were randomized into an observation group and a control group , 70 cases in each one .
-METHODS	In the control group , the conventional physical therapies ( Bobath therapy and lower extremities therapy ) and scalp acupuncture ( seven-intelligent needles , motor area , sensory area , foot-motor-sensory area and balance area ) were adopted .
-METHODS	In the observation group , on the basis of the treatment as the control group , the three-spasm-needle therapy was applied to Jiejian , Xuehaishang and Houxuehai .
-METHODS	The physical therapies were given once every day , acupuncture was given once every two days , the treatment of 20 days made one session .
-METHODS	There were 15 to 20 days at the interval among the sessions and 3 sessions were required totally .
-METHODS	Separately before and after treatment , the modified Ashworth scale was used to evaluate the adductor muscle tension , and measure the adductor muscle angle , and D and E regions of gross motor function measure ( GMFM-88 ) were adopted for clinical efficacy evaluation .
-RESULTS	After treatment , the scores of the adductor muscle tension were decreased to different extends in the two groups ( both P < 0.01 ) , the adductor muscle angle was increased as compared with that before treatment ( both P < 0.01 ) and the scores of D and F regions in GMFM-88 were all improved ( all P < 0.01 ) .
-RESULTS	The efficacy in the observation group was more significant than that in the control group ( all P < 0.01 ) .
-CONCLUSIONS	The three-spasm-needle therapy effectively reduces adductor muscle tension and improves the range of motion in hip joint , independent walking , running and jumping abilities in the children of spasmodic cerebral palsy .
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-###25176289
-BACKGROUND	We hypothesized that in patients with stable coronary artery disease and stenosis , percutaneous coronary intervention ( PCI ) performed on the basis of the fractional flow reserve ( FFR ) would be superior to medical therapy .
-METHODS	In 1220 patients with stable coronary artery disease , we assessed the FFR in all stenoses that were visible on angiography .
-METHODS	Patients who had at least one stenosis with an FFR of 0.80 or less were randomly assigned to undergo FFR-guided PCI plus medical therapy or to receive medical therapy alone .
-METHODS	Patients in whom all stenoses had an FFR of more than 0.80 received medical therapy alone and were included in a registry .
-METHODS	The primary end point was a composite of death from any cause , nonfatal myocardial infarction , or urgent revascularization within 2 years .
-RESULTS	The rate of the primary end point was significantly lower in the PCI group than in the medical-therapy group ( 8.1 % vs. 19.5 % ; hazard ratio , 0.39 ; 95 % confidence interval [ CI ] , 0.26 to 0.57 ; P < 0.001 ) .
-RESULTS	This reduction was driven by a lower rate of urgent revascularization in the PCI group ( 4.0 % vs. 16.3 % ; hazard ratio , 0.23 ; 95 % CI , 0.14 to 0.38 ; P < 0.001 ) , with no significant between-group differences in the rates of death and myocardial infarction .
-RESULTS	Urgent revascularizations that were triggered by myocardial infarction or ischemic changes on electrocardiography were less frequent in the PCI group ( 3.4 % vs. 7.0 % , P = 0.01 ) .
-RESULTS	In a landmark analysis , the rate of death or myocardial infarction from 8 days to 2 years was lower in the PCI group than in the medical-therapy group ( 4.6 % vs. 8.0 % , P = 0.04 ) .
-RESULTS	Among registry patients , the rate of the primary end point was 9.0 % at 2 years .
-CONCLUSIONS	In patients with stable coronary artery disease , FFR-guided PCI , as compared with medical therapy alone , improved the outcome .
-CONCLUSIONS	Patients without ischemia had a favorable outcome with medical therapy alone .
-CONCLUSIONS	( Funded by St. Jude Medical ; FAME 2 ClinicalTrials.gov number , NCT01132495 . )
-
-###24721289
-BACKGROUND	Advertising has been implicated in the declining quality of the American diet , but much of the research has been conducted with children rather than adults .
-BACKGROUND	This study tested the effects of televised food advertising on adult food choice .
-METHODS	Participants ( N = 351 ) were randomized into one of 4 experimental conditions : exposure to food advertising vs. exposure to non-food advertising , and within each of these groups , exposure to a task that was either cognitively demanding or not cognitively demanding .
-METHODS	The number of unhealthy snacks chosen was subsequently measured , along with total calories of the snacks chosen .
-RESULTS	Those exposed to food advertising chose 28 % more unhealthy snacks than those exposed to non-food-advertising ( 95 % CI : 7 % - 53 % ) , with a total caloric value that was 65 kcal higher ( 95 % CI : 10-121 ) .
-RESULTS	The effect of advertising was not significant among those assigned to the low-cognitive-load group , but was large and significant among those assigned to the high-cognitive-load group : 43 % more unhealthy snacks ( 95 % CI : 11 % - 85 % ) and 94 more total calories ( 95 % CI : 19-169 ) .
-CONCLUSIONS	Televised food advertising has strong effects on individual food choice , and these effects are magnified when individuals are cognitively occupied by other tasks .
-
-###25440820
-OBJECTIVE	To evaluate of efficacy of transgluteal ( supine ) approach for shock wave lithotripsy ( SWL ) in treatment of distal ureteric stones .
-METHODS	This prospective , randomized , comparative study was conducted on 98 patients .
-METHODS	Patients were randomly assigned into 2 groups : group A ( n = 49 ; prone position ) and group B ( n = 49 ; supine position , transgluteal ) .
-METHODS	Inclusion criteria included patients with radiopaque lower ureteric stones 10 mm .
-METHODS	Exclusion criteria included radiolucent stones , stones > 10 mm , the need for any auxiliary procedure , and any contraindication for SWL .
-METHODS	Post-SWL evaluation included plain x-ray of kidney , ureter , and bladder at 2 weeks after treatment and then at monthly intervals after treatment for 3 months .
-METHODS	Stone-free status was defined as no residual stone fragments visible on plain x-ray .
-METHODS	Treatment failure was defined as persistence of stone fragments at 3 months or the need for ureteroscopy .
-RESULTS	Stone-free rate after 1 treatment session was achieved in 44.9 % and 75.5 % for prone and supine positions , respectively .
-RESULTS	Proceeding to ureteroscopy , after failure of the second SWL session to clear the stones , was done in 34.7 % and 8.2 % for prone and supine positions , respectively .
-RESULTS	The overall success rate for SWL treatment in prone and supine groups was 65.3 % and 91.8 % , respectively ( P < .001 ) .
-CONCLUSIONS	Transgluteal SWL while patient in supine position proved efficacy for treatment of distal ureteric stones .
-CONCLUSIONS	Larger group studies comparing the results of SWL in supine position with those of prone position and also with those of ureteroscopy may enrich our data to reach a consensus for the ideal management of distal ureteric stones .
-
-###24682026
-OBJECTIVE	Transcatheter aortic valve replacement ( TAVR ) is an effective treatment option for high-risk patients with severe aortic stenosis .
-OBJECTIVE	Different from surgery , transcatheter deployment of valves requires either a balloon-expandable or self-expandable system .
-OBJECTIVE	A randomized comparison of these 2 systems has not been performed .
-OBJECTIVE	To determine whether the balloon-expandable device is associated with a better success rate than the self-expandable device .
-METHODS	The CHOICE study was an investigator-initiated trial in high-risk patients with severe aortic stenosis and an anatomy suitable for the transfemoral TAVR procedure .
-METHODS	One hundred twenty-one patients were randomly assigned to receive a balloon-expandable valve ( Edwards Sapien XT ) and 120 were assigned to receive a self-expandable valve ( Medtronic CoreValve ) .
-METHODS	Patients were enrolled between March 2012 and December 2013 at 5 centers in Germany .
-METHODS	Transfemoral TAVR with a balloon-expandable or self-expandable device .
-METHODS	The primary end point was device success , which is a composite end point including successful vascular access and deployment of the device and retrieval of the delivery system , correct position of the device , intended performance of the heart valve without moderate or severe regurgitation , and only 1 valve implanted in the proper anatomical location .
-METHODS	Secondary end points included cardiovascular mortality , bleeding and vascular complications , postprocedural pacemaker placement , and a combined safety end point at 30 days , including all-cause mortality , major stroke , and other serious complications .
-RESULTS	Device success occurred in 116 of 121 patients ( 95.9 % ) in the balloon-expandable valve group and 93 of 120 patients ( 77.5 % ) in the self-expandable valve group ( relative risk [ RR ] , 1.24 , 95 % CI , 1.12-1 .37 , P < .001 ) .
-RESULTS	This was attributed to a significantly lower frequency of residual more-than-mild aortic regurgitation ( 4.1 % vs 18.3 % ; RR , 0.23 ; 95 % CI , 0.09-0 .58 ; P < .001 ) and the less frequent need for implanting more than 1 valve ( 0.8 % vs 5.8 % , P = .03 ) in the balloon-expandable valve group .
-RESULTS	Cardiovascular mortality at 30 days was 4.1 % in the balloon-expandable valve group and 4.3 % in the self-expandable valve group ( RR , 0.97 ; 95 % CI , 0.29-3 .25 ; P = .99 ) .
-RESULTS	Bleeding and vascular complications were not significantly different , and the combined safety end point occurred in 18.2 % of those in the balloon-expandable valve group and 23.1 % of the self-expandable valve group ( RR , 0.79 ; 95 % CI , 0.48-1 .30 ; P = .42 ) .
-RESULTS	Placement of a new permanent pacemaker was less frequent in the balloon-expandable valve group ( 17.3 % vs 37.6 % , P = .001 ) .
-CONCLUSIONS	Among patients with high-risk aortic stenosis undergoing TAVR , the use of a balloon-expandable valve resulted in a greater rate of device success than use of a self-expandable valve .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01645202 .
-
-###25058216
-OBJECTIVE	There is limited information about the effect of erythropoietin or a high hemoglobin transfusion threshold after a traumatic brain injury .
-OBJECTIVE	To compare the effects of erythropoietin and 2 hemoglobin transfusion thresholds ( 7 and 10 g/dL ) on neurological recovery after traumatic brain injury .
-METHODS	Randomized clinical trial of 200 patients ( erythropoietin , n = 102 ; placebo , n = 98 ) with closed head injury who were unable to follow commands and were enrolled within 6 hours of injury at neurosurgical intensive care units in 2 US level I trauma centers between May 2006 and August 2012 .
-METHODS	The study used a factorial design to test whether erythropoietin would fail to improve favorable outcomes by 20 % and whether a hemoglobin transfusion threshold of greater than 10 g/dL would increase favorable outcomes without increasing complications .
-METHODS	Erythropoietin or placebo was initially dosed daily for 3 days and then weekly for 2 more weeks ( n = 74 ) and then the 24 - and 48-hour doses were stopped for the remainder of the patients ( n = 126 ) .
-METHODS	There were 99 patients assigned to a hemoglobin transfusion threshold of 7 g/dL and 101 patients assigned to 10 g/dL .
-METHODS	Intravenous erythropoietin ( 500 IU/kg per dose ) or saline .
-METHODS	Transfusion threshold maintained with packed red blood cells .
-METHODS	Glasgow Outcome Scale score dichotomized as favorable ( good recovery and moderate disability ) or unfavorable ( severe disability , vegetative , or dead ) at 6 months postinjury .
-RESULTS	There was no interaction between erythropoietin and hemoglobin transfusion threshold .
-RESULTS	Compared with placebo ( favorable outcome rate : 34/89 [ 38.2 % ; 95 % CI , 28.1 % to 49.1 % ] ) , both erythropoietin groups were futile ( first dosing regimen : 17/35 [ 48.6 % ; 95 % CI , 31.4 % to 66.0 % ] , P = .13 ; second dosing regimen : 17/57 [ 29.8 % ; 95 % CI , 18.4 % to 43.4 % ] , P < .001 ) .
-RESULTS	Favorable outcome rates were 37/87 ( 42.5 % ) for the hemoglobin transfusion threshold of 7 g/dL and 31/94 ( 33.0 % ) for 10 g/dL ( 95 % CI for the difference , -0.06 to 0.25 , P = .28 ) .
-RESULTS	There was a higher incidence of thromboembolic events for the transfusion threshold of 10 g/dL ( 22/101 [ 21.8 % ] vs 8/99 [ 8.1 % ] for the threshold of 7 g/dL , odds ratio , 0.32 [ 95 % CI , 0.12 to 0.79 ] , P = .009 ) .
-CONCLUSIONS	In patients with closed head injury , neither the administration of erythropoietin nor maintaining hemoglobin concentration of greater than 10 g/dL resulted in improved neurological outcome at 6 months .
-CONCLUSIONS	The transfusion threshold of 10 g/dL was associated with a higher incidence of adverse events .
-CONCLUSIONS	These findings do not support either approach in this setting .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00313716 .
-
-###25819861
-BACKGROUND	Poor adherence to evidence-based medications in heart failure ( HF ) is a major cause of avoidable hospitalizations , disability , and death .
-BACKGROUND	To test the feasibility of improving medication adherence , we performed a randomized proof-of-concept study of a self-management intervention in high-risk patients with HF .
-METHODS	Patients with HF who screened positively for poor adherence ( < 6 Morisky Medication Adherence Scale 8-item ) were randomized to either the intervention or attention control group .
-METHODS	In the intervention group ( n = 44 ) , a nurse conducted self-management training before discharge that focused on identification of medication goals , facilitation of medication-symptom associations , and use of a symptom response plan .
-METHODS	The attention control group ( n = 42 ) received usual care ; both groups received follow-up calls at 1 week .
-METHODS	However , the content of follow-up calls for the attention control group was unrelated to HF medications or symptoms .
-METHODS	General linear mixed models were used to evaluate the magnitude of change in adherence and symptom-related events at 3 - , 6 - , and 12-month follow-up clinic visits .
-METHODS	Efficacy was measured as improved medication adherence using nurse-assessed pill counts at each time point .
-RESULTS	Pooled over all time points , patients in the intervention group were more likely to be adherent to medications compared with patients in the attention control group ( odds ratio 3.92 , t = 3.51 , P = .0007 ) .
-CONCLUSIONS	A nurse-delivered , self-care intervention improved medication adherence in patients with advanced HF .
-CONCLUSIONS	Further work is needed to examine whether this intervention can be sustained to improve clinical outcomes .
-
-###25499341
-BACKGROUND	The Rho-kinase pathway has been shown to be involved in the pathogenesis of PAH .
-BACKGROUND	As yet , however , the acute effects of the Rho-kinase inhibitor fasudil have not been compared with established pulmonary selective vasodilators in patients with PAH .
-BACKGROUND	We compared the acute effects of intravenous fasudil with inhaled iloprost in patients with pulmonary arterial hypertension ( PAH ) .
-METHODS	Using a crossover design , 50 patients with PAH ( idiopathic PAH , PAH associated with repaired left-to-right cardiac shunts , or connective tissue disease ) were randomized to iloprost inhalation ( 5 g ) and intravenous fasudil ( 30 mg over 30 min ) .
-METHODS	Hemodynamic data were collected at baseline and during acute drug exposure .
-RESULTS	Comparable decreases were observed in mean pulmonary artery pressure ( -4.6 4.3 mmHg vs. -4.8 4.2 mmHg ) and pulmonary vascular resistance ( -3.0 3.0 Wood U vs. -2.2 2.7 Wood U ) with fasudil infusion and iloprost inhalation , respectively , during acute challenge .
-RESULTS	However , fasudil infusion resulted in a more pronounced increase in mean cardiac output and mixed venous oxygen saturation compared with iloprost inhalation ( 13.7 17.1 % vs. 6.9 15.0 % ; p = 0.044 and 4.5 5.3 % vs. 2.7 8.2 % ; p = 0.044 , respectively ) .
-RESULTS	Whereas inhaled iloprost resulted in a non-significant increase in mean systemic arterial oxygen saturation ( 0.8 3.6 % ) , infused fasudil resulted in a non-significant reduction ( -0.6 1.1 % ) .
-CONCLUSIONS	Infused fasudil improved pulmonary hemodynamics in patients with PAH without significant toxicity .
-
-###25457929
-OBJECTIVE	Prior research has shown that youth with co-occurring tic disorders and obsessive-compulsive disorder ( OCD ) may differ from those with non-tic-related OCD in terms of clinical characteristics and treatment responsiveness .
-OBJECTIVE	A broad definition of `` tic-related '' was used to examine whether children with tics in the Pediatric OCD Treatment Study II differed from those without tics in terms of demographic and phenomenological characteristics and acute treatment outcomes .
-METHODS	Participants were 124 youth aged 7 to 17 years , inclusive , with a primary diagnosis of OCD who were partial responders to an adequate serotonin reuptake inhibitor ( SRI ) trial .
-METHODS	Participants were randomized to medication management , medication management plus instructions in cognitive-behavioral therapy ( CBT ) , or medication management plus full CBT .
-METHODS	Tic status was based on the presence of motor and/or vocal tics on the Yale Global Tic Severity Scale .
-RESULTS	Tics were identified in 53 % of the sample .
-RESULTS	Those with tic-related OCD did not differ from those with non-tic-related OCD in terms of age , family history of tics , OCD severity , OCD-related impairment , or comorbidity .
-RESULTS	Those with tics responded equally in all treatment conditions .
-CONCLUSIONS	Tic-related OCD was very prevalent using a broad definition of tic status .
-CONCLUSIONS	Results suggest that youth with this broad definition of tic-related OCD do not have increased OCD severity or inference , higher comorbidity rates or severity , or worsened functioning , and support the use of CBT in this population .
-CONCLUSIONS	This highlights the importance of not making broad assumptions about OCD symptoms most likely to occur in an individual with comorbid tics .
-CONCLUSIONS	Clinical trial registration information-Treatment of Pediatric OCD for SRI Partial Responders ; http://clinicaltrials.gov; NCT00074815 .
-
-###24443001
-OBJECTIVE	Since clinical non-response to 21000mg rituximab has previously been found to be associated with incomplete B cell depletion , we determined , in a randomised controlled proof of concept study , whether patients with initial incomplete B cell depletion would benefit from an additional infusion of rituximab at week 4 .
-METHODS	Patients with active rheumatoid arthritis despite methotrexate received a first infusion of rituximab 1000mg and were tested for persistent B cells using highly sensitive flow cytometry on day 15 .
-METHODS	All received a second infusion of 1g ( according to license ) , but patients with persistent B cells were subsequently randomised double-blind to receive , 2weeks later , either a third infusion of 1000mg rituximab or placebo .
-METHODS	Clinical response was determined by European League Against Rheumatism ( EULAR ) and American College of Rheumatology ( ACR ) criteria .
-RESULTS	Baseline characteristics were balanced between groups .
-RESULTS	Treatment with 31000mg rituximab resulted in significantly greater depletion ( lower B cell and plasmablast numbers between 8 and 28weeks ) paralleled by significantly better EULAR and ACR20 response rates at 40weeks ( p = 0.035 and p = 0.027 , respectively ) and 52weeks ( p = 0.021 and p = 0.043 , respectively ) compared with 21000mg .
-RESULTS	Immunoglobulin titres remained stable in both arms , and adverse event rates were balanced .
-CONCLUSIONS	In rituximab-treated patients with incomplete B cell depletion ( predictive of poor response ) , an extra 1000mg infusion of rituximab at 4weeks produced both better depletion and clinical responses than placebo with no worsening of safety .
-CONCLUSIONS	Degree of depletion is an important , but modifiable , determinant of response .
-
-###25337948
-OBJECTIVE	To compare treatment effects when patients with insomnia and depression receive treatment for either insomnia or depression .
-METHODS	A 9-w randomized controlled trial with 6 - and 12-mo follow-up .
-METHODS	Internet Psychiatry Clinic , Stockholm , Sweden .
-METHODS	Forty-three adults in whom comorbid insomnia and depression were diagnosed , recruited via media and assessed by psychiatrists .
-METHODS	Guided Internet-delivered cognitive behavior therapy ( ICBT ) for either insomnia or depression .
-RESULTS	Primary outcome measures were symptom self-rating scales ( Insomnia Severity Index [ ISI ] and the Montgomery sberg Depression Rating Scale [ MADRS-S ] ) , assessed before and after treatment with follow-up after 6 and 12 mo. .
-RESULTS	The participants ' use of sleep medication and need for further treatment after completion of ICBT was also investigated .
-RESULTS	The insomnia treatment was more effective than the depression treatment in reducing insomnia severity during treatment ( P = 0.05 ) , and equally effective in reducing depression severity .
-RESULTS	Group differences in insomnia severity were maintained during the 12-mo follow-up period .
-RESULTS	Post treatment , participants receiving treatment for insomnia had significantly less self-rated need for further insomnia treatment ( P < 0.001 ) and used less sleep medication ( P < 0.05 ) than participants receiving treatment for depression .
-RESULTS	The need for depression treatment was similar in both groups .
-CONCLUSIONS	In this study , Internet-delivered treatment with cognitive behavior therapy ( ICBT ) for insomnia was more effective than ICBT for depression for patients with both diagnoses .
-CONCLUSIONS	This indicates , in line with previous research , that insomnia when comorbid with depression is not merely a symptom of depression , but needs specific treatment .
-BACKGROUND	The trial was registered at Clinicaltrials.gov , registration ID : NCT01256099 .
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-###25044799
-OBJECTIVE	To identify an early treatment milestone that optimizes sensitivity and specificity for predicting 5 % weight loss at Week ( W ) 52 in patients with and without type 2 diabetes on lorcaserin or placebo .
-METHODS	Post hoc area under the curve for receiver operating characteristic analyses of data from three phase 3 trials comparing lifestyle modification + placebo with lifestyle modification + lorcaserin .
-METHODS	A total of 6897 patients ( 18-65 years ; BMI , 30-45 or 27-29 .9 kg/m ( 2 ) with 1 comorbidity ) were randomized to placebo or lorcaserin 10 mg bid .
-METHODS	Changes ( baseline to W52 ) in cardiometabolic parameters were assessed .
-RESULTS	Response ( 5 % weight loss from baseline ) at W12 was a strong predictor of W52 response .
-RESULTS	Lorcaserin patients with a W12 response achieved mean W52 weight losses of 10.6 kg ( without diabetes ) and 9.3 kg ( with diabetes ) .
-RESULTS	Proportions achieving 5 % and 10 % weight loss at W52 were 85.5 % and 49.8 % ( without diabetes ) , and 70.5 % and 35.9 % ( with diabetes ) .
-RESULTS	Lorcaserin patients who did not achieve a W12 response lost 3.2 kg ( without diabetes ) and 2.8 kg ( with diabetes ) at W52 .
-RESULTS	Responders had greater improvements in cardiometabolic risk factors than the modified intent-to-treat ( MITT ) population , consistent with greater weight loss .
-CONCLUSIONS	5 % weight loss by W12 predicts robust response to lorcaserin at 1 year .
-
-###25427135
-OBJECTIVE	We evaluated a novel visual representation for current and near-term prosthetic vision .
-OBJECTIVE	Augmented depth emphasizes ground obstacles and floor-wall boundaries in a depth-based visual representation .
-OBJECTIVE	This is achieved by artificially increasing contrast between obstacles and the ground surface via a novel ground plane extraction algorithm specifically designed to preserve low-contrast ground-surface boundaries .
-METHODS	The effectiveness of augmented depth was examined in human mobility trials compared against standard intensity-based ( Intensity ) , depth-based ( Depth ) and random ( Random ) visual representations .
-METHODS	Eight participants with normal vision used simulated prosthetic vision with 20 phosphenes and eight perceivable brightness levels to traverse a course with randomly placed small and low-contrast obstacles on the ground .
-RESULTS	The number of collisions was significantly reduced using augmented depth , compared with intensity , depth and random representations ( 48 % , 44 % and 72 % less collisions , respectively ) .
-CONCLUSIONS	These results indicate that augmented depth may enable safe mobility in the presence of low-contrast obstacles with current and near-term implants .
-CONCLUSIONS	This is the first demonstration that an augmentation of the scene ensuring key objects are visible may provide better outcomes for prosthetic vision .
-
-###24511717
-BACKGROUND	From the empirical study , light-emitting diode ( LED ) phototherapy is effective for treatment of neonatal hyperbilirubinemia .
-BACKGROUND	However commercial LED phototherapy equipment is still expensive .
-BACKGROUND	Thus , in-house LED phototherapy equipment has been developed .
-OBJECTIVE	To compare efficacy between in-house LED to conventional phototherapy equipment in the treatment of neonatal hyperbilirubinemia at Mae Sot Hospital .
-METHODS	This was a randomized controlled trial .
-METHODS	Fifty newborns with hyperbilirubinemia were allocated to LED phototherapy group and conventional group .
-METHODS	Baseline characteristics were compared and analyzed by descriptive statistics , exact probability and student t-test , and change in serum bilirubin level was analyzed by multilevel regression analysis .
-RESULTS	There were 25 patients in each of the two groups .
-RESULTS	The median duration of phototherapy in LED group was 25 hours , whereas the conventional group required 48 hours ( p < 0.001 ) and the average serum bilirubin level in LED group decreased more rapidly than in conventional group ( p = 0.007 ) .
-RESULTS	Hyperthermia were found in 22 infants from conventional group ( 88 % ) compared to 11 infants from LED group ( 44 % ) ( p = 0.002 ) .
-CONCLUSIONS	In-house LED phototherapy equipment is more effective than conventional phototherapy in the reduction of serum bilirubin level and occurrence of hyperthermia during treatment is less .
-
-###25072098
-BACKGROUND	The CHRNA5-CHRNA3-CHRNB4 locus is associated with self-reported smoking behavior and also harbors the strongest genetic associations with chronic obstructive pulmonary disease ( COPD ) and lung cancer .
-BACKGROUND	Because the associations with lung disease remain after adjustment for self-reported smoking behaviors , it has been asserted that CHRNA5-CHRNA3-CHRNB4 variants increase COPD and lung cancer susceptibility independently of their effects on smoking .
-OBJECTIVE	To compare the genetic associations of exhaled carbon monoxide ( CO ) , a biomarker of current cigarette exposure , with self-reported smoking behaviors .
-METHODS	A total of 1,521 European American and 247 African American current smokers recruited into smoking cessation studies were assessed for CO at intake before smoking cessation .
-METHODS	DNA samples were genotyped using the Illumina Omni2 .5 microarray .
-METHODS	Genetic associations with CO and smoking behaviors ( cigarettes smoked per day , Fagerstrom test for nicotine dependence ) were studied .
-RESULTS	Variants in the CHRNA5-CHRNA3-CHRNB4 locus , including rs16969968 , a nonsynonymous variant in CHRNA5 , are genomewide association study-significantly associated with CO ( = 2.66 ; 95 % confidence interval [ CI ] , 1.74-3 .58 ; P = 1.65 10 ( -8 ) ) , and this association remains strong after adjusting for smoking behavior ( = 2.18 ; 95 % CI , 1.32-3 .04 ; P = 7.47 10 ( -7 ) ) .
-RESULTS	The correlation between CO and cigarettes per day is statistically significantly lower ( z = 3.43 ; P = 6.07 10 ( -4 ) ) in African Americans ( r = 0.14 ; 95 % CI , 0.02-0 .26 ; P = 0.003 ) than in European-Americans ( r = 0.36 ; 95 % CI , 0.31-0 .40 ; P = 0.0001 ) .
-CONCLUSIONS	Exhaled CO , a biomarker that is simple to measure , captures aspects of cigarette smoke exposure in current smokers beyond the number of cigarettes smoked per day .
-CONCLUSIONS	Behavioral measures of smoking are therefore insufficient indices of cigarette smoke exposure , suggesting that genetic associations with COPD or lung cancer that persist after adjusting for self-reported smoking behavior may still reflect genetic effects on smoking exposure .
-
-###24862029
-OBJECTIVE	The core clinical and neuropathological feature of the autosomal dominant spinocerebellar ataxias ( SCAs ) is cerebellar degeneration .
-OBJECTIVE	Mutations in the known genes explain only 50 % to 60 % of SCA cases .
-OBJECTIVE	To date , no effective treatments exist , and the knowledge of drug-treatable molecular pathways is limited .
-OBJECTIVE	The examination of overlapping mechanisms and the interpretation of how ataxia genes interact will be important in the discovery of potential disease-modifying agents .
-OBJECTIVE	To address the possible relationships among known SCA genes , predict their functions , identify overlapping pathways , and provide a framework for candidate gene discovery using whole-transcriptome expression data .
-METHODS	We have used a systems biology approach based on whole-transcriptome gene expression analysis .
-METHODS	As part of the United Kingdom Brain Expression Consortium , we analyzed the expression profile of 788 brain samples obtained from 101 neuropathologically healthy individuals ( 10 distinct brain regions each ) .
-METHODS	Weighted gene coexpression network analysis was used to cluster 24 SCA genes into gene coexpression modules in an unsupervised manner .
-METHODS	The overrepresentation of SCA transcripts in modules identified in the cerebellum was assessed .
-METHODS	Enrichment analysis was performed to infer the functions and molecular pathways of genes in biologically relevant modules .
-METHODS	Molecular functions and mechanisms implicating SCA genes , as well as lists of relevant coexpressed genes as potential candidates for novel SCA causative or modifier genes .
-RESULTS	Two cerebellar gene coexpression modules were statistically enriched in SCA transcripts ( P = .021 for the tan module and P = 2.8710-5 for the light yellow module ) and contained established granule and Purkinje cell markers , respectively .
-RESULTS	One module includes genes involved in the ubiquitin-proteasome system and contains SCA genes usually associated with a complex phenotype , while the other module encloses many genes important for calcium homeostasis and signaling and contains SCA genes associated mostly with pure ataxia .
-CONCLUSIONS	Using normal gene expression in the human brain , we identified significant cell types and pathways in SCA pathogenesis .
-CONCLUSIONS	The overrepresentation of genes involved in calcium homeostasis and signaling may indicate an important target for therapy in the future .
-CONCLUSIONS	Furthermore , the gene networks provide new candidate genes for ataxias or novel genes that may be critical for cerebellar function .
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-###26003882
-OBJECTIVE	To assess the effectiveness of supreme laryngeal mask airway ( SLMA ) over face mask ventilation for preventing need for endotracheal intubation at birth .
-METHODS	We report a prospective , randomized , parallel 1:1 , unblinded , controlled trial .
-METHODS	After a short-term educational intervention on SLMA use , infants 34-week gestation and/or expected birth weight 1500 g requiring positive pressure ventilation ( PPV ) at birth were randomized to resuscitation by SLMA or face mask .
-METHODS	The primary outcome was the success rate of the resuscitation devices ( SLMA or face mask ) defined as the achievement of an effective PPV preventing the need for endotracheal intubation .
-RESULTS	We enrolled 142 patients ( 71 in SLMA and 71 in face mask group , respectively ) .
-RESULTS	Successful resuscitation rate was significantly higher with the SLMA compared with face mask ventilation ( 91.5 % vs 78.9 % ; P = .03 ) .
-RESULTS	Apgar score at 5 minutes was significantly higher in SLMA than in face mask group ( P = .02 ) .
-RESULTS	Neonatal intensive care unit admission rate was significantly lower in SLMA than in face mask group ( P = .02 ) .
-RESULTS	No complications related to the procedure occurred .
-CONCLUSIONS	In newborns with gestational age 34 weeks and/or expected birth weight 1500 g needing PPV at birth , the SLMA is more effective than face mask to prevent endotracheal intubation .
-CONCLUSIONS	The SLMA is effective in clinical practice after a short-term educational intervention .
-BACKGROUND	Registered with ClinicalTrials.gov : NCT01963936 .
-
-###25488088
-OBJECTIVE	To determine the optimum mode of delivery for women in preterm breech labour at a gestational age of 26 to 32 weeks .
-METHODS	A multicentre randomised controlled trial .
-METHODS	Twenty-six hospitals in England , UK .
-METHODS	Women with a singleton breech fetus in spontaneous preterm labour between 26 and 32 completed weeks of gestation , with no clear indication for a caesarean section or vaginal breech delivery .
-METHODS	Random allocation to either ` intention to delivery vaginally ' or ` intention to deliver by caesarean section ' .
-METHODS	Perinatal mortality , neonatal morbidity , maternal morbidity and gestation at delivery .
-RESULTS	The trial was closed after 17 months because of low recruitment , by which time substantial numbers of women had been in the eligible gestation period .
-RESULTS	Thirteen women from six hospitals were recruited .
-RESULTS	One infant , randomised to and delivered vaginally , was stillborn .
-RESULTS	Three fetal presentations were cephalic at delivery despite a diagnosis of breech presentation at trial entry .
-RESULTS	No formal statistical analysis was performed due to the small numbers .
-CONCLUSIONS	No conclusions about the optimum mode of delivery for women in preterm labour with a fetus presenting by the breech can be drawn from this trial .
-CONCLUSIONS	The low accrual rate was due to clinicians ' reluctance to randomise eligible women , reflecting the circumstances and nature of the trial .
-
-###24304555
-OBJECTIVE	This randomized controlled study tested the effectiveness of individualized activities , led by certified nursing assistants ( CNAs ) , to increase positive and reduce negative affect and behavior among nursing home residents with dementia .
-METHODS	Nursing home residents with mild to advanced dementia ( N = 180 ) were randomly assigned to usual care ( UC , n = 93 ) or 1 of 2 experimental conditions .
-METHODS	Residents in the attention control group ( AC , N = 43 ) participated in standardized one-to-one activities with their CNAs .
-METHODS	Individualized Positive Psychosocial Intervention ( IPPI ) participants ( n = 44 ) received a CNA-led activity matched to their interests and ability .
-METHODS	Outcomes were residents ' positive and negative affect and verbal and nonverbal behavior .
-RESULTS	The IPPI and AC groups experienced similar benefits-more pleasure , alertness , engagement , positive touch , and positive verbal behavior-compared with UC .
-RESULTS	The AC group displayed more anger , uncooperativeness , and very negative verbal behavior than UC or IPPI .
-CONCLUSIONS	This study demonstrates the value of individualized activities for nursing home residents with dementia .
-CONCLUSIONS	In a stringent test , residents were happier and less angry during a customized intervention compared with a standardized intervention .
-CONCLUSIONS	Even brief individualized CNA-led activities bring pleasure to nursing home residents and constitute an effective strategy to enhance positive affect and engagement in persons with dementia .
-
-###25773607
-BACKGROUND	Evolocumab , a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 ( PCSK9 ) , significantly reduced low-density lipoprotein ( LDL ) cholesterol levels in short-term studies .
-BACKGROUND	We conducted two extension studies to obtain longer-term data .
-METHODS	In two open-label , randomized trials , we enrolled 4465 patients who had completed 1 of 12 phase 2 or 3 studies ( `` parent trials '' ) of evolocumab .
-METHODS	Regardless of study-group assignments in the parent trials , eligible patients were randomly assigned in a 2:1 ratio to receive either evolocumab ( 140 mg every 2 weeks or 420 mg monthly ) plus standard therapy or standard therapy alone .
-METHODS	Patients were followed for a median of 11.1 months with assessment of lipid levels , safety , and ( as a prespecified exploratory analysis ) adjudicated cardiovascular events including death , myocardial infarction , unstable angina , coronary revascularization , stroke , transient ischemic attack , and heart failure .
-METHODS	Data from the two trials were combined .
-RESULTS	As compared with standard therapy alone , evolocumab reduced the level of LDL cholesterol by 61 % , from a median of 120 mg per deciliter to 48 mg per deciliter ( P < 0.001 ) .
-RESULTS	Most adverse events occurred with similar frequency in the two groups , although neurocognitive events were reported more frequently in the evolocumab group .
-RESULTS	The risk of adverse events , including neurocognitive events , did not vary significantly according to the achieved level of LDL cholesterol .
-RESULTS	The rate of cardiovascular events at 1 year was reduced from 2.18 % in the standard-therapy group to 0.95 % in the evolocumab group ( hazard ratio in the evolocumab group , 0.47 ; 95 % confidence interval , 0.28 to 0.78 ; P = 0.003 ) .
-CONCLUSIONS	During approximately 1 year of therapy , the use of evolocumab plus standard therapy , as compared with standard therapy alone , significantly reduced LDL cholesterol levels and reduced the incidence of cardiovascular events in a prespecified but exploratory analysis .
-CONCLUSIONS	( Funded by Amgen ; OSLER-1 and OSLER-2 ClinicalTrials.gov numbers , NCT01439880 and NCT01854918 . )
-
-###24247812
-BACKGROUND	Previous metoprolol studies in myocardial infarction patients were performed with immediate-release ( IR ) metoprolol .
-BACKGROUND	This study aims to evaluate if extended-release metoprolol CR/XL once daily gives a similar - blockade over 24 h compared to multiple dosing of metoprolol IR .
-METHODS	After 2 days of routine metoprolol treatment , 27 patients with suspected acute myocardial infarction were randomized to open-label treatment with metoprolol IR ( 50 mg four times daily or 100 mg twice daily ) or metoprolol CR/XL 200 mg once daily for 3 days .
-RESULTS	Metoprolol CR/XL 200 mg once daily gave more pronounced suppression of peak heart rate , with lower peak and less variation in peak to trough plasma levels .
-RESULTS	There were no differences in AUC between the CR/XL and IR formulations , although the trough plasma metoprolol levels were comparable for metoprolol CR/XL 200 mg once daily and metoprolol IR 50 mg four times daily , but lower for metoprolol IR 100 mg twice daily .
-RESULTS	Both treatments were well tolerated .
-CONCLUSIONS	Metoprolol CR/XL 200 mg once daily showed lower peak and less variation in peak to trough plasma levels compared to multiple dosing of metoprolol IR with the same AUC .
-CONCLUSIONS	This was accompanied by a more uniform - blockade over time , which was reflected by heart rate , and a more pronounced suppression of peak heart rate with similar tolerability .
-CONCLUSIONS	This suggests metoprolol CR/XL may be used as an alternative to metoprolol IR in patients with myocardial infarction .
-
-###25224610
-BACKGROUND	Antiretroviral ( ARV ) - based pre-exposure prophylaxis ( PrEP ) is a promising new HIV prevention strategy .
-BACKGROUND	However , variable levels of adherence have yielded mixed results across several PrEP trials and populations .
-BACKGROUND	It is not clear how taking ARV - traditionally used for HIV treatment - is perceived and how that perception may affect the use of these products as preventives .
-BACKGROUND	We explored the views and experiences of VOICE participants , their male partners and community members regarding the use of ARV as PrEP in the VOICE trial and the implications of these shared meanings for adherence .
-METHODS	VOICE-C was a qualitative ancillary study conducted at the Johannesburg site of VOICE , a multisite , double-blind , placebo-controlled randomised trial testing tenofovir gel , oral tenofovir and oral Truvada for HIV PrEP .
-METHODS	We interviewed 102 randomly selected female VOICE participants , 22 male partners and 40 community members through in-depth interviews , serial ethnography , or focus group discussions .
-METHODS	All interviews were audiotaped , transcribed , translated and coded thematically for analysis .
-RESULTS	The concept of ARV for prevention was understood to varying degrees across all study groups .
-RESULTS	A majority of VOICE participants understood that the products contained ARV , more so for the tablets than for the gel .
-RESULTS	Although participants knew they were HIV negative , ARV was associated with illness .
-RESULTS	Male partners and community members echoed these sentiments , highlighting confusion between treatment and prevention .
-RESULTS	Concerned that they would be mistakenly identified as HIV positive , VOICE participants often concealed use of or hid their study products .
-RESULTS	This occasionally led to relationship conflicts or early trial termination .
-RESULTS	HIV stigma and its association with ARV , especially the tablets , was articulated in rumour and gossip in the community , the workplace and the household .
-RESULTS	Although ARV were recognised as potent and beneficial medications , transforming the AIDS body from sickness to health , they were regarded as potentially harmful for those uninfected .
-CONCLUSIONS	VOICE participants and others in the trial community struggled to conceptualise the idea of using ARV for prevention .
-CONCLUSIONS	This possibly influenced willingness to adopt ARV-based prevention in the VOICE clinical trial .
-CONCLUSIONS	Greater investments should be made to increase community understanding of ARV for prevention and to mitigate pervasive HIV stigma .
-
-###24813065
-OBJECTIVE	Specific genetic or biological markers may predict inadequate response to therapy for major depressive disorder ( MDD ) .
-OBJECTIVE	The objective of the current post hoc analysis was to evaluate the effect of specific biological and genetic markers on the antidepressant efficacy of adjunctive L-methylfolate 15 mg versus placebo from a trial of inadequate responders to selective serotonin reuptake inhibitors ( SSRIs ) .
-METHODS	The double-blind , randomized , placebo-controlled trial used the sequential parallel comparison design .
-METHODS	Outpatients with SSRI-resistant MDD ( DSM-IV criteria ) received L-methylfolate 15 mg/d for 60 days , placebo for 30 days followed by L-methylfolate 15 mg/d for 30 days , or placebo for 60 days .
-METHODS	The effects of baseline levels of select biological and genetic markers individually and combined on treatment response to L-methylfolate versus placebo were evaluated ; the primary response measure was the 28-Item Hamilton Depression Rating Scale ( HDRS-28 ) .
-METHODS	The first patient was enrolled July 14 , 2009 , and the last patient completed April 28 , 2011 .
-RESULTS	Seventy-five patients were enrolled .
-RESULTS	Patients with specific biological ( body mass index 30 kg/m , elevated plasma levels of high-sensitivity C-reactive protein or 4-hydroxy-2-nonenal , low S-adenosylmethionine/S-adenosylhomocysteine ratio ) and genetic markers at baseline had significantly ( P .05 ) greater pooled mean change from baseline on the HDRS-28 with L-methylfolate versus placebo .
-RESULTS	Pooled mean change from baseline on the Clinical Global Impressions-Severity of Illness scale was significantly ( P < .05 ) greater with L-methylfolate versus placebo for most genetic markers .
-RESULTS	Most combinations of baseline biological and genetic markers predicted significantly ( P .05 ) greater reductions in pooled mean change from baseline in HDRS-28 scores with L-methylfolate versus placebo .
-CONCLUSIONS	Biomarkers associated with inflammation or metabolism and genomic markers associated with L-methylfolate synthesis and metabolism may identify patients with SSRI-resistant depression who are responsive to adjunctive therapy with L-methylfolate 15 mg .
-CONCLUSIONS	Confirmatory studies are needed .
-BACKGROUND	ClinicalTrials.gov identifier : NCT00955955 .
-
-###25543421
-OBJECTIVE	To compare the efficacy difference in treatment of depression in breast cancer between the combined therapy of acupuncture and auricular acupressure and western medication .
-METHODS	Sixty patients were randomized into an observation group and a control group , 30 cases in each one .
-METHODS	In the observation group , the combined therapy of acupuncture and auricular acupressure was adopted .
-METHODS	The main acupoints of acupuncture were Hegu ( LI 4 ) , Tai-chong ( LR 3 ) , Baihui ( GV 20 ) , Zusanli ( ST 36 ) , Qihai ( CV 6 ) , etc. .
-METHODS	The supplementary acupoints were combined according to the syndrome differentiation .
-METHODS	The treatment was given once every day , 5 treatments a week , at the interval of 2 days among weeks .
-METHODS	The auricular acupressure was applied to gan ( CO12 , liver ) , pi ( CO13 , spleen ) , neifenmi ( CO18 , endocrine ) , etc. , once every 4 days , on each side in one treatment .
-METHODS	In the control group , fluoxetine hydrochloride capsules were prescribed for oral administration , 20 mg , once a day .
-METHODS	The Hamilton depression rating scale ( HAMD ) was used to assess the disease severity and efficacy before treatment , in 4 and 8 weeks of treatment separately .
-METHODS	HAMD factor changes were observed before treatment and at the end of the 8th week .
-METHODS	The Asberg antidepressants scale ( SERS ) was applied to safety assessment .
-RESULTS	The total effective rate was 86.7 % ( 26/30 ) in the observation group , better than 63.3 % ( 19/30 ) in the control group ( P < 0.05 ) .
-RESULTS	At the end of the 4th and 8th weeks , HAMD scores were all reduced apparently in the two groups ( all P < 0.01 ) .
-RESULTS	At the end of the 8th week , the scores of the HAMD factor 1 ( anxiety/somatic system ) , factor 5 ( retardation ) and factor 6 ( sleep disturbance ) were all reduced as compared with those before treatment in the two groups ( all P < 0.01 ) ; the results in the observation group were better than those in the control group ( P < 0.05 , P < 0.01 ) .
-RESULTS	SERS score in the observation group was lower obviously than that in the control group ( P < 0.01 ) .
-CONCLUSIONS	The combined therapy of acupuncture and auricular acupressure achieves the antidepression effect in treatment of depression in breast cancer and has less side effects and high safety .
-CONCLUSIONS	The efficacy is superior to fluoxetine hydrochloride capsules .
-
-###24449631
-OBJECTIVE	To compare intercellular adhesion molecule-1 ( ICAM-1 ) and vascular cell adhesion molecule-1 ( VCAM-1 ) serum levels between patients with stable ( SAP ) and unstable angina pectoris ( USAP ) undergoing coronary angiography ( CAG ) , investigate effects of CAG on ICAM-1 , VCAM-1 levels in SAP , USAP patients ; probable different effects of non-ionic radiocontrast media ( RCM ) , iso-osmotic iodixanol and low osmolar iopamidol , on these adhesion molecules ( AM ) .
-METHODS	In this randomized , prospective study , 2 groups consisting of patients with SAP ( n = 22 ) and USAP ( n = 22 ) undergoing CAG were included .
-METHODS	For halves of each group iopamidol , for the other halves iodixanol were used as RCM , in turn for randomization .
-METHODS	The patients were divided into 4 subgroups according to clinical presentations and used RCM ( SAP-iodixanol , SAP-iopamidol USAP-iodixanol , USAP-iopamidol ) .
-METHODS	ICAM-1 , VCAM-1 levels were measured just before and 12 hours after CAG .
-METHODS	Repeated measurements were compared with two-way ANOVA test .
-RESULTS	Baseline VCAM-1 concentration was higher in USAP group than SAP group ( p = 0.001 ) .
-RESULTS	ICAM-1 , VCAM-1 concentrations increased significantly following CAG in SAP , USAP groups .
-RESULTS	ICAM-1 , VCAM-1 concentration increments ; did n't reach statistical significance in SAP-iodixanol subgroup , reached a borderline significance in SAP-iopamidol subgroup ( p = 0.06 ) .
-RESULTS	In USAP-iodixanol subgroup ; only VCAM-1 ( p < 0.001 ) , in USAP-iopamidol subgroup ; ICAM-1 ( p = 0.009 ) , VCAM-1 ( p = 0.006 ) levels increased significantly following CAG .
-RESULTS	No complication was observed .
-CONCLUSIONS	To our knowledge , this is the first study indicating ICAM-1 , VCAM-1 inducing effect of CAG in patients with SAP , USAP and differential effects of iodixanol and iopamidol on ICAM-1 , VCAM-1 serum levels .
-CONCLUSIONS	Further studies are needed to clarify the effects of CAG and different RCM on vascular inflammation , vessel injury , serum AM levels and their clinical significance .
-CONCLUSIONS	This study should be taken as a pilot , hypothesis-generating study .
-
-###24484688
-BACKGROUND	The subcutaneous ( SC ) route has recently emerged as a rehydration method with potential advantages in the geriatric population .
-BACKGROUND	Nevertheless , little is known about its application during hospitalization .
-BACKGROUND	The objective of the present study is to evaluate the subcutaneous non-inferiority efficacy in hydration against the intravenous ( IV ) route in elderly patients with dehydration .
-METHODS	A prospective , randomized and controlled interventional trial of patients 65 years and older admitted to an Acute Geriatric Unit with mild to moderate dehydration and oral intolerance , evaluating the non-inferiority of subcutaneous fluid therapy versus the intravenous route .
-METHODS	The intervention consisted of the administration of up to 1.5 l/day/route for 72 hours subcutaneous vs. intravenous , evaluating the variations in biochemical parameters ( urea , creatinine , osmolarity ) , clinical outcome , and route related complications .
-RESULTS	Sixty seven patients completed the study ( 34 SC , age 86.4 8.5 years , 41 % women , vs. 33 IV , 84.3 6.6 , 54.5 % women , with no significant differences ) .
-RESULTS	The amount of fluid administered per day by route was 1.320 ml 400 SC vs. 1.480 ml 340 IV , P = .092 .
-RESULTS	During follow similar reductions were observed between groups without any statistical significance , with mean differences pre-postintervention of urea ( 49.6 52.3 SC vs. 50.3 52.3 IV , P = .96 ) ; creatinine ( 0.68 0.66 SC vs. 0.60 0.49 IV , P = .58 ) , and osmolarity ( 15.6 24.4 SC vs. 21.1 31 IV , P = .43 ) .
-RESULTS	Fewer catheter extraction episodes were observed in the SC group , which also was the group most prone to peri-clysis edema .
-CONCLUSIONS	The efficacy of subcutaneous rehydration in elderly hospitalized patients with mild-moderate dehydration is not inferior to that obtained intravenously , and may even have additional advantages .
-
-###25466509
-BACKGROUND	Patients with metastatic colorectal cancer ( mCRC ) previously-treated with oxaliplatin benefit significantly from the addition of aflibercept to FOLFIRI in relation to overall survival , progression-free survival and response rate .
-METHODS	The results for efficacy and safety over the time course of the VEGF Trap ( aflibercept ) with irinotecan in colorectal cancer after failure of oxaliplatin regimen trial were analysed based on data from 1226 patients randomised to receive FOLFIRI plus either aflibercept ( n = 612 ) or placebo ( n = 614 ) .
-METHODS	Hazard ratios ( HR ) by 6-month time period were estimated using a piecewise Cox proportional hazard model .
-METHODS	Severity of adverse events ( AEs ) was graded using National Cancer Institute Common Terminology Criteria , version 3.0 .
-RESULTS	The estimated probabilities of survival were 38.5 % versus 30.9 % at 18 months , 28.0 % versus 18.7 % at 24 months and 22.3 % versus 12.0 % at 30 months , for the aflibercept - and placebo-treated arms , respectively .
-RESULTS	The proportional improvement in the HR over time was consistent with the survival probability results ; survival at 24 months was improved by 50 % and almost doubled at 30 months .
-RESULTS	The majority of worst-grade AEs occurred within the first four cycles of treatment and in a small percent of treatment cycles and were mostly reversible .
-RESULTS	Common chemotherapy - and anti-vascular epithelial growth factor ( VEGF ) - associated AEs occurred rarely and in a small proportion of cycles with the majority being of single occurrence .
-CONCLUSIONS	The addition of aflibercept to FOLFIRI showed a continued and persistent improvement in overall survival over time in patients with mCRC .
-CONCLUSIONS	Although grade 3-4 AEs were more frequent in the aflibercept arm , they occurred in early treatment cycles and decreased sharply following initial presentation .
-
-###25425504
-BACKGROUND	Compared to American Whites , African Americans have a higher prevalence of type 2 diabetes mellitus ( T2DM ) , experiencing poorer metabolic control and greater risks for complications and death .
-BACKGROUND	Patient-level factors , such as diabetes knowledge , self-management skills , empowerment , and perceived control , account for > 90 % of the variance observed in outcomes between these racial groups .
-BACKGROUND	There is strong evidence that self-management interventions that include telephone-delivered diabetes education and skills training are effective at improving metabolic control in diabetes .
-BACKGROUND	Web-based home telemonitoring systems in conjunction with active care management are also effective ways to lower glycosylated hemoglobin A1c values when compared to standard care , and provide feedback to patients ; however , there are no studies in African Americans with poorly controlled T2DM that examine the use of technology-based feedback to tailor or augment diabetes education and skills training .
-BACKGROUND	This study provides a unique opportunity to address this gap in the literature .
-METHODS	We describe an ongoing 4-year randomized clinical trial , which will test the efficacy of a technology-intensified diabetes education and skills training ( TIDES ) intervention in African Americans with poorly controlled T2DM .
-METHODS	Two hundred male and female AfricanAmerican participants , 21 years of age or older and with a glycosylated hemoglobin A1c level 8 % , will be randomized into one of two groups for 12 weeks of telephone interventions : ( 1 ) TIDES intervention group or ( 2 ) a usual-care group .
-METHODS	Participants will be followed for 12 months to ascertain the effect of the interventions on glycemic control .
-METHODS	Our primary hypothesis is that , among African Americans with poorly controlled T2DM , patients randomized to the TIDES intervention will have significantly greater reduction in glycosylated hemoglobin A1c at 12 months of follow-up compared to the usual-care group .
-CONCLUSIONS	Results from this study will add to the current literature examining how best to deliver diabetes education and skills training and provide important insight into effective strategies to improve metabolic control and hence reduce diabetes complications and mortality rates in African Americans with poorly controlled T2DM .
-BACKGROUND	This study was registered with the National Institutes of Health Clinical Trials Registry on 13 March 2014 ( ClinicalTrials.gov identifier # NCT02088658 ) .
-
-###25516028
-OBJECTIVE	To compare the effects of different types of physical and mental activity on self-reported sleep quality over 12 weeks in older adults with cognitive and sleep complaints .
-METHODS	Randomized controlled trial .
-METHODS	General community .
-METHODS	Seventy-two inactive community-dwelling older adults with self-reported sleep and cognitive problems ( mean age 73.3 6.1 ; 60 % women ) .
-METHODS	Random allocation to four arms using a two-by-two factorial design : aerobic + cognitive training , aerobic + educational DVD , stretching + cognitive training , and stretching + educational DVD arms ( 60 min/d , 3 d/wk for physical and mental activity for 12 weeks ) .
-METHODS	Change in sleep quality using seven questions from the Sleep Disorders Questionnaire on the 2005 to 2006 National Health and Nutrition Examination Survey ( range 0-28 , with higher scores reflecting worse sleep quality ) .
-METHODS	Analyses used intention-to-treat methods .
-RESULTS	Sleep quality scores did not differ at baseline , but there was a significant difference between the study arms in change in sleep quality over time ( P < .005 ) .
-RESULTS	Mean sleep quality scores improved significantly more in the stretching + educational DVD arm ( 5.1 points ) than in the stretching + cognitive training ( 1.2 points ) , aerobic + educational DVD ( 1.1 points ) , or aerobic + cognitive training ( 0.25 points ) arms ( all P < .05 , corrected for multiple comparisons ) .
-RESULTS	Differences between arms were strongest for waking at night ( P = .02 ) and taking sleep medications ( P = .004 ) .
-CONCLUSIONS	Self-reported sleep quality improved significantly more with low-intensity physical and mental activities than with moderate - or high-intensity activities in older adults with self-reported cognitive and sleep difficulties .
-CONCLUSIONS	Future longer-term studies with objective sleep measures are needed to corroborate these results .
-
-###24385637
-OBJECTIVE	The present study examined health and physical performance as mediators of the association between driving cessation and mortality among older residents of small and large cities .
-METHODS	Participants ( N = 2,793 ) were from the Advanced Cognitive Training for Independent and Vital Elderly ( ACTIVE ) study .
-METHODS	Participants ' driving status and health were measured at baseline , and mortality rates were observed across the subsequent 5 years .
-RESULTS	Overall , mortality risk was 1.68 times higher for nondrivers versus drivers ; this relationship was significantly mediated by physical performance and social , physical , and general health .
-RESULTS	For large-city residents , mediation effects for all mediators were significant and complete .
-RESULTS	For small-city residents , only physical and general health were significant mediators , and these effects were partial .
-CONCLUSIONS	Health difficulties that accompany or follow driving cessation may explain the association between driving cessation and mortality , particularly for residents of large cities , where alternative transportation options may be more numerous .
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-###24565103
-OBJECTIVE	To determine whether modifying a plastic speculum with a flexible sheath would improve visualization and decrease pain during vaginal examination .
-METHODS	We conducted a prospective randomized controlled trial of 136 women undergoing vaginal speculum examination at an outpatient obstetrics and gynecology faculty practice .
-METHODS	Patients underwent examination via a standardized technique with either a medium-sized plastic speculum ( standard ) or an identical speculum modified with a flexible polypropylene sheath ( sheathed ) .
-METHODS	Investigators recorded the percentage of the cervix visualized .
-METHODS	After speculum insertion , patients recorded pain using a 10-cm visual analog scale .
-RESULTS	There were no substantial demographic differences between the standard ( n = 67 ) and the sheathed ( n = 68 ) groups .
-RESULTS	Investigators were able to visualize a significantly greater percentage of the cervix using the sheathed speculum compared with the standard speculum ( 95.1 % 8.2 % vs. 78.2 % 18.4 % ; P < 0.001 ) , representing a 21.6 % improvement in visualization , and were able to visualize the entire cervix in 42 ( 61.8 % ) patients when using the sheathed speculum compared with 11 ( 16.4 % ) patients undergoing standard speculum examination ( P < 0.001 ) .
-RESULTS	Patients undergoing examination with the sheathed speculum reported a nonsignificant decrease in pain scores ( 1.0 vs 1.2 ; P = 0.087 ) .
-CONCLUSIONS	A sheathed speculum significantly improves visualization of the cervix , without compromising patient comfort .
-CONCLUSIONS	ClinicalTrials.gov : NCT01670630 .
-
-###25453519
-OBJECTIVE	To assess change in physical functioning ( pain , range of motion ( ROM ) , strength , and endurance ) after 8 weeks of therapeutic-yoga .
-METHODS	Planned analyses of data from a randomized pilot study of yoga after stroke .
-METHODS	University-based research laboratory .
-METHODS	People with chronic stroke ( N = 47 ) randomized to therapeutic-yoga ( n = 37 ) or wait-list control ( n = 10 ) .
-METHODS	16 sessions of therapeutic yoga ( twice a week/8 weeks ) .
-METHODS	Yoga was delivered in a standardized and progressive format with postures , breathing , and meditation , and relaxation in sitting , standing , and supine .
-METHODS	Pain was assessed with the PEG , a 3-item functional measure of the interference of pain .
-METHODS	ROM included neck and hip active and passive ROM measurements ) .
-METHODS	Upper and lower extremity strength were assessed with the arm curl test and chair-to-stand test , respectively .
-METHODS	Endurance was assessed with the 6-minute walk and modified 2-min step test .
-RESULTS	After a Bonferroni Correction , pain , neck ROM , hip passive ROM , upper extremity strength , and the 6-min walk scores all significantly improved after 8 weeks of engaging in yoga .
-RESULTS	No changes occurred in the wait-list control group .
-CONCLUSIONS	A group therapeutic-yoga intervention may improve multiple aspects of physical functioning after stroke .
-CONCLUSIONS	Such an intervention may be complementary to traditional rehabilitation .
-
-###24920942
-BACKGROUND	Prophylactic fluid preloading before spinal anesthesia has been a routine procedure to prevent maternal hypotension during cesarean delivery .
-BACKGROUND	Unlike colloid , timing of infusion of crystalloid may be important because of its short stay in intravascular space .
-BACKGROUND	We hypothesized that crystalloid loading just after intrathecal injection compared to preload would be more effective in preventing maternal hypotension .
-METHODS	In this prospective controlled study , sixty parturients were randomized to receive 15ml/kg of crystalloid before ( preload group ) or after ( coload group ) intrathecal drug injection for spinal anesthesia .
-METHODS	Hypotension was defined if systolic arterial pressure decreased below 80 % of baseline and ephedrine was administered to treat hypotension .
-METHODS	The incidence of hypotension and the total dose of ephedrine were checked .
-METHODS	Blood pressure , heart rate and nausea before childbirth were assessed .
-METHODS	Neonatal outcomes were evaluated with Apgar scores and umbilical blood gas analysis .
-RESULTS	The incidence of hypotension was lower in the coload group compared to the preload group ( 53 % vs. 83 % , P = 0.026 ) .
-RESULTS	The blood pressure showed the bigger drop during spinal anesthesia in the preload group ( 3413 vs. 2510mmHg , P = 0.002 ) and smaller dose of ephedrine was required in the coload group ( 7.5 [ 0-30 ] vs. 15 [ 0-40 ] mg , P = 0.015 ) .
-RESULTS	The incidence of nausea was also lower in the coload group ( 27 % vs. 60 % , P = 0.019 ) .
-RESULTS	Neonatal outcome measures were comparable between two groups .
-CONCLUSIONS	In case of using crystalloids for cesarean delivery , coload is more effective than preload for the prevention of maternal hypotension after spinal anesthesia .
-BACKGROUND	Clinical Research Information Service KCT0000324 ( Jan 12 ( th ) , 2012 ) .
-
-###24660827
-OBJECTIVE	To evaluate the effects of benzalkonium chloride ( BAK ) on the blood-aqueous ( BAB ) and blood-retinal barriers ( BRB ) of pseudophakic eyes .
-METHODS	Prospective , randomized , investigator-masked , comparative study .
-METHODS	Patients were randomly assigned to preservative-free artificial tears or BAK-preserved artificial tears .
-METHODS	One drop of artificial tears was instilled 4 times a day in the study eye , starting the day after randomization for 30 days .
-METHODS	Anterior chamber flare was assessed by a laser flare meter ( LFM ) and macular thickness measurements were obtained with optical coherence tomography , before , 15 , and 30 days after randomization .
-RESULTS	A total of 44 healthy eyes of 44 pseudophakic volunteers were recruited .
-RESULTS	There were no significant differences regarding demographics ( age , gender , and race distributions ) and clinical characteristics ( eye , mean intraocular pressure , and mean best-corrected visual acuity ) between the 2 groups ( P > 0.05 ) .
-RESULTS	No significant differences in baseline mean LFM values were observed ( P = 0.262 ) .
-RESULTS	However , we detected a statistically significant increase in mean LFM measurements in the BAK-preserved group ( 11.4 5.1 ph/ms ) ( P = 0.017 ) after 15 days .
-RESULTS	After 30 days , the BAK-preserved group maintained significantly higher flare values ( 11.9 5.9 ph/ms ) compared with baseline ( P = 0.043 ) .
-RESULTS	On the other hand , the preservative-free group showed mean flare values of 8.4 2.5 ph/ms , not significantly different from those obtained at baseline ( P = 1.00 ) .
-RESULTS	We observed no statistically significant change in macular thickness measurements at days 15 and 30 in either group ( P > 0.05 ) .
-RESULTS	Cystoid macular edema was not detected in this series .
-CONCLUSIONS	Our results suggest that a short-term exposure to BAK can cause disruption of the BAB , without altering the BRB in pseudophakic eyes .
-
-###25749502
-OBJECTIVE	Patients with decompensated cirrhosis have significantly reduced survival without liver transplantation .
-OBJECTIVE	Granulocyte colony-stimulating factor ( G-CSF ) has been shown to increase survival in patients with acute-on-chronic liver failure , and erythropoietin promoted hepatic regeneration in animal studies .
-OBJECTIVE	We performed a double-blind , randomized , placebo-controlled trial to determine whether co-administration of these growth factors improved outcomes for patients with advanced cirrhosis .
-METHODS	In a prospective study , consecutive patients with decompensated cirrhosis seen at the Institute of Liver and Biliary Sciences , New Delhi ( from May 2011 through June 2012 ) were randomly assigned to groups given subcutaneous G-CSF ( 5 g/kg/d ) for 5 days and then every third day ( 12 total doses ) , along with subcutaneous darbopoietin ( 40 mcg/wk ) for 4 weeks ( GDP group , n = 29 ) , or only placebos ( control group , n = 26 ) .
-METHODS	All patients also received standard medical therapy and were followed for 12 months .
-METHODS	Histology was performed on liver biopsies .
-METHODS	The primary end point was survival at 12 months .
-RESULTS	Baseline characteristics of patients were comparable ; alcohol intake was the most common etiology of cirrhosis .
-RESULTS	A higher proportion of patients in the GDP group than controls survived until 12 months ( 68.6 % vs 26.9 % ; P = .003 ) .
-RESULTS	At 12 months , Child-Turcotte Pugh scores were reduced by 48.6 % in the GDP group and 39.1 % in the control group , from baseline ( P = .001 ) ; Model for End Stage Liver Disease scores were reduced by 40.4 % and 33 % , respectively ( P = .03 ) .
-RESULTS	The need for large-volume paracentesis was significantly reduced in GDP group , compared with controls ( P < .05 ) .
-RESULTS	A lower proportion of patients in the GDP group developed septic shock ( 6.9 % ) during follow-up compared with controls ( 38.5 % ; P = .005 ) .
-RESULTS	No major adverse events were observed in either group .
-CONCLUSIONS	In a single-center randomized trial , a significantly larger proportion of patients with decompensated cirrhosis given a combination of G-CSF and darbopoietin survived for 12 months more than patients given only placebo .
-CONCLUSIONS	The combination therapy also reduced liver severity scores and sepsis to a greater extent than placebo .
-CONCLUSIONS	Clinicaltrials.gov ID : NCT01384565 .
-
-###25584931
-BACKGROUND	The abuse potential of prescription opioids is well established .
-BACKGROUND	This study compared positive , subjective drug effects of single , equal doses of biphasic immediate release ( IR ) / extended release ( ER ) hydrocodone bitartrate ( HB ) / acetaminophen ( acetyl-p-aminophenol [ APAP ] ) 7.5 / 325 mg tablets versus IR HB/APAP 7.5 / 325-mg tablets and placebo .
-METHODS	Healthy adult recreational users of prescription opioids entered this randomized , double-blind , double-dummy , active - and placebo-controlled , seven-way crossover study .
-METHODS	Participants received single , total doses of IR/ER HB/APAP 22.5 / 975 mg ( intact ; three active tablets ) and 45/1950 mg ( intact and crushed [ encapsulated ] ; six active tablets ) , IR HB/APAP 22.5 / 975 mg ( intact ; three active tablets ) and 45/1950 mg ( intact and crushed [ encapsulated ] ; six active tablets ) , and placebo .
-METHODS	Peak subjective effects ( E ( max ) ) ; time to peak effects ( TE ( max ) ) ; and area under the drug-effect curves for drug liking , high , and good drug effects were measured using visual analog scales .
-METHODS	Median values with 95 % confidence interval ( CI ) were compared using analysis of variance .
-RESULTS	Among completers ( n = 52 ) , IR/ER HB/APAP produced delayed and lower peak effects compared to equal doses of IR HB/APAP .
-RESULTS	Comparing intact tablets , the drug liking E ( max ) ( median [ 95 % CI ] ) was significantly lower for IR/ER HB/APAP 45/1950 mg ( 78.0 [ 73.0 , 81.0 ] ) than an equal dose of IR HB/APAP ( 89.5 [ 85.0 , 93.0 ] ; difference , -8.5 [ -12.0 , -6.0 ] ; P < 0.001 ) .
-RESULTS	Similar results were observed for intact IR/ER HB/APAP and IR HB/APAP 22.5 / 975 mg .
-RESULTS	Crushing IR/ER HB/APAP 45/1950 mg delayed these effects compared with an equal dose of crushed IR HB/APAP and intact IR/ER HB/APAP .
-CONCLUSIONS	IR/ER HB/APAP resulted in lower subjective positive drug effects than an equal dose of IR HB/APAP .
-CONCLUSIONS	Crushing IR/ER HB/APAP also delayed the onset of subjective effects compared with intact IR/ER HB/APAP .
-CONCLUSIONS	These findings suggest that biphasic IR/ER HB/APAP has lower abuse potential than IR HB/APAP in single equal doses .
-BACKGROUND	This Phase I clinical trial conducted in the USA was not registered .
-
-###24313446
-OBJECTIVE	To examine the effect of action and coping planning strategies in the adherence to medication among outpatients with coronary artery disease .
-BACKGROUND	Action and coping planning strategies are based on implementation intention , which requires self-regulation by the individual , to prioritize intentionally planned responses over learned or habitual ones , from daily routines to stressful situations .
-METHODS	Randomized controlled trial .
-METHODS	Participants ( n = 115 ) were randomized into intervention ( use of action and coping planning strategies , n = 59 ) or control ( usual care , n = 56 ) groups .
-METHODS	The study was conducted between June 2010-May 2011 in two in-person visits : baseline and 2-month follow-up .
-METHODS	Participants in the intervention group received telephone reinforcement between baseline and 2-month follow-up .
-METHODS	Adherence to medication for cardioprotection and symptoms relief was evaluated by proportion of adherence , global measure of adherence evaluation and Morisky Self-Reported Measure of Medication Adherence Scale at both baseline and 2-month follow-up .
-RESULTS	When using the measure of global measure of adherence , participants in the intervention group reported adherence to therapy more often than controls ( odds ratio = 5.3 ) , but no statistically significant change was observed in the other two outcome measures .
-CONCLUSIONS	This study has shown that individuals who use action and coping planning report higher adherence to drug treatment , when measured by the global adherence evaluation .
-CONCLUSIONS	Further studies with longer follow-ups are needed to assess if the effect of planning strategies has long-term duration .
-
-###24696051
-OBJECTIVE	Intravitreal ranibizumab or bevacizumab are the most used drugs for treatment of neovascular age-related macular degeneration ( nAMD ) .
-OBJECTIVE	Repeated intravitreal injections represent an economic burden and may be associated with serious complications .
-OBJECTIVE	The aim of this study is to evaluate the number of needed injections within 1 year of treatment .
-METHODS	55 patients over 50 years of age with nAMD and visual acuity ( VA ) between 20/40 and 20/320 were included .
-METHODS	Scheduled visits and treatment were performed monthly for 1 year .
-METHODS	After a loading dose of three intravitreal injections ( either ranibizumab = group 1 or bevacizumab = group 2 ) , an `` as needed '' regimen was performed .
-METHODS	Primary endpoint was a difference in the injection frequencies of ranibizumab and bevacizumab .
-METHODS	Secondary endpoints were best corrected visual acuity ( BCVA ) and central retinal thickness ( CRT ) .
-RESULTS	Difference in number of injections was not significant ( 5.001.67 ( ranibizumab group ) vs. 5.802.28 ( bevacizumab group ) , p = 0.084 ) .
-RESULTS	Mean BCVA was 59.1216.64 letters after 12 months if patients received ranibizumab ( p = 0.001 ) and 64.7517.03 letters if patients received bevacizumab ( p = 0.037 ) .
-RESULTS	There was no statistical significance between the two groups ( p = 0.631 ) .
-RESULTS	The mean CRT did not differ significantly between groups after 12 months ( 315.6765.86 m for ranibizumab , 350.47102.84 m for bevacizumab , p = 0.088 ) .
-CONCLUSIONS	There was no difference in number of treatment , BCVA and CRT after 1 year between ranibizumab and bevacizumab in patients with nAMD .
-
-###24607004
-BACKGROUND	Reintroduction of Variola major as an agent of bioterrorism remains a concern .
-BACKGROUND	Time to seroconversion and plaque reduction neutralizing antibody titers ( PRNT ) of 1 or 2 standard doses ( SD ) were compared to a single high dose ( HD ) of modified vaccinia Ankara ( MVA ) .
-METHODS	Ninety subjects were randomized 1:1 to receive 1 HD or 2 SD of MVA subcutaneously on Days 0 and 28 in a placebo-controlled trial .
-METHODS	Serum was collected for PRNT and ELISA .
-METHODS	Subjects were followed for safety for the entire study .
-RESULTS	The HD was well-tolerated .
-RESULTS	Using Bavarian Nordic 's ELISA , subjects in both groups achieved seroconversion by Study Day 15 ( HD ) and Day 28 ( SD ) .
-RESULTS	Before second vaccination , the hazard rate of seroconverting for the HD group was 1.7 times the SD group with a median time for seroconversion of 14 days for both groups .
-RESULTS	The peak titer of one HD vaccine was superior to one dose of SD vaccine but inferior to the peak titer after the second dose of the SD vaccination regimen .
-RESULTS	Using Saint Louis University 's PRNT , peak titers were 95.8 and 65.2 for the HD and SD groups , respectively , prior to second vaccination .
-RESULTS	Non-inferiority of the SD group was not established .
-RESULTS	The proportions of positives were 93.3 % ( 42/45 ) and 82.2 % ( 37/45 ) for the HD and SD groups , respectively .
-RESULTS	The peak titer after two standard doses was superior to that of the HD .
-CONCLUSIONS	HD MVA was safe and well-tolerated .
-CONCLUSIONS	While the hazard rate for seroconverting was significantly higher in the HD group before second dose , the effect was small as the median time to seroconversion was identical .
-CONCLUSIONS	When comparing PRNT , non-inferiority of one SD was not established and the peak titers were low for both groups .
-CONCLUSIONS	The HD peak response was inferior to the standard two-dose regimen response based on ELISA and PRNT .
-
-###25033137
-OBJECTIVE	We examined whether and how an HIV prevention diffusion-based intervention spread throughout participants ' online social networks and whether changes in social network ties were associated with increased HIV prevention and testing behaviors .
-METHODS	We randomly assigned 112 primarily racial/ethnic minority men who have sex with men ( MSM ) to receive peer-delivered HIV ( intervention ) or general health ( control ) information over 12 weeks through closed Facebook groups .
-METHODS	We recorded participants ' public Facebook friend networks at baseline ( September 2010 ) and follow-up ( February 2011 ) , and assessed whether changes in network growth were associated with changes in health engagement and HIV testing .
-RESULTS	Within-group ties increased in both conditions from baseline to follow-up .
-RESULTS	Among the intervention group , we found a significant positive relation between increased network ties and using social media to discuss sexual behaviors .
-RESULTS	We found a positive trending relationship between increased network ties and likelihood of HIV testing , follow-up for test results , and participation in online community discussions .
-RESULTS	No significant differences were seen within control groups .
-CONCLUSIONS	Among high-risk MSM , peer-led social media HIV prevention interventions can increase community cohesion .
-CONCLUSIONS	These changes appear to be associated with increased HIV prevention and testing behaviors .
-
-###25595151
-OBJECTIVE	To assess the efficacy of recombinant human erythropoietin ( rhEPO ) in amyotrophic lateral sclerosis ( ALS ) .
-METHODS	Patients with probable laboratory-supported , probable or definite ALS were enrolled by 25 Italian centres and randomly assigned ( 1:1 ) to receive intravenous rhEPO 40,000 IU or placebo fortnightly as add-on treatment to riluzole 100mg daily for 12months .
-METHODS	The primary composite outcome was survival , tracheotomy or > 23h non-invasive ventilation ( NIV ) .
-METHODS	Secondary outcomes were ALSFRS-R , slow vital capacity ( sVC ) and quality of life ( ALSAQ-40 ) decline .
-METHODS	Tolerability was evaluated analysing adverse events ( AEs ) causing withdrawal .
-METHODS	The randomisation sequence was computer-generated by blocks , stratified by centre , disease severity ( ALSFRS-R cut-off score of 33 ) and onset ( spinal or bulbar ) .
-METHODS	The main outcome analysis was performed in all randomised patients and by intention-to-treat for the entire population and patients stratified by severity and onset .
-METHODS	The study is registered , EudraCT 2009-016066-91 .
-RESULTS	We randomly assigned 208 patients , of whom 5 ( 1 rhEPO and 4 placebo ) withdrew consent and 3 ( placebo ) became ineligible ( retinal thrombosis , respiratory insufficiency , SOD1 mutation ) before receiving treatment ; 103 receiving rhEPO and 97 placebo were eligible for analysis .
-RESULTS	At 12months , the annualised rate of death ( rhEPO 0.11 , 95 % CI 0.06 to 0.20 ; placebo : 0.08 , CI 0.04 to 0.17 ) , tracheotomy or > 23h NIV ( rhEPO 0.16 , CI 0.10 to 0.27 ; placebo 0.18 , CI 0.11 to 0.30 ) did not differ between groups , also after stratification by onset and ALSFRS-R at baseline .
-RESULTS	Withdrawal due to AE was 16.5 % in rhEPO and 8.3 % in placebo .
-RESULTS	No differences were found for secondary outcomes .
-CONCLUSIONS	RhEPO 40,000 IU fortnightly did not change the course of ALS .
-
-###25038326
-OBJECTIVE	To assess the safety and efficacy of dendritic cell vaccination in metastatic uveal melanoma .
-METHODS	Interventional case series .
-METHODS	We analyzed 14 patients with metastatic uveal melanoma treated with dendritic cell vaccination .
-METHODS	Patients with metastatic uveal melanoma received at least 3 vaccinations with autologous dendritic cells , professional antigen-presenting cells loaded with melanoma antigens gp100 and tyrosinase .
-METHODS	The main outcome measures were safety , immunologic response , and overall survival .
-RESULTS	Tumor-specific immune responses were induced with dendritic cell vaccination in 4 ( 29 % ) of 14 patients .
-RESULTS	Dendritic cell-vaccinated patients showed a median overall survival with metastatic disease of 19.2 months , relatively long compared with that reported in the literature .
-RESULTS	No severe treatment-related toxicities ( common toxicity criteria grade 3 or 4 ) were observed .
-CONCLUSIONS	Dendritic cell vaccination is feasible and safe in metastatic uveal melanoma .
-CONCLUSIONS	Dendritic cell-based immunotherapy is potent to enhance the host 's antitumor immunity against uveal melanoma in approximately one third of patients .
-CONCLUSIONS	Compared with other prospective studies with similar inclusion criteria , dendritic cell vaccination may be associated with longer than average overall survival in patients with metastatic uveal melanoma .
-
-###25239718
-BACKGROUND	Catheter-associated urinary tract infection ( CAUTI ) risk is directly related to duration of indwelling urinary catheters ( IUCs ) , rising beyond 2 days of catheterization .
-METHODS	We conducted a cluster randomized study in nonintensive care units of Nurses Improving Care for Healthsystem Elders ( NICHE ) hospitals .
-METHODS	Electronic surveillance data were used in an audit and feedback intervention for frontline nurses to reduce IUC duration .
-METHODS	Multivariable methods were used to identify the difference in average IUC duration and proportion of patients with IUC duration < 3 days between patients in an early intervention group and a delayed intervention group , adjusting for patient , unit , and hospital characteristics .
-RESULTS	A total of 24 units at 19 NICHE hospitals reported 13,499 adult patients with IUCs over 18 months .
-RESULTS	Early and delayed intervention groups had important baseline differences in IUC utilization .
-RESULTS	Use of evidence-based CAUTI prevention measures increased during study participation .
-RESULTS	In multivariable analysis , the average IUC duration and proportion of patients with IUC duration < 3 days were not improved in the early intervention group compared with the delayed intervention group .
-CONCLUSIONS	The impact of the audit and feedback intervention was not significant despite the uptake of evidence-based CAUTI prevention practices .
-
-###24867013
-OBJECTIVE	Abdominal pain after cholecystectomy is common and may be attributed to sphincter of Oddi dysfunction .
-OBJECTIVE	Management often involves endoscopic retrograde cholangiopancreatography ( ERCP ) with manometry and sphincterotomy .
-OBJECTIVE	To determine whether endoscopic sphincterotomy reduces pain and whether sphincter manometric pressure is predictive of pain relief .
-METHODS	Multicenter , sham-controlled , randomized trial involving 214 patients with pain after cholecystectomy without significant abnormalities on imaging or laboratory studies , and no prior sphincter treatment or pancreatitis randomly assigned ( August 6 , 2008-March 23 , 2012 ) to undergo sphincterotomy or sham therapy at 7 referral medical centers .
-METHODS	One-year follow-up was blinded .
-METHODS	The final follow-up visit was March 21 , 2013 .
-METHODS	After ERCP , patients were randomized 2:1 to sphincterotomy ( n = 141 ) or sham ( n = 73 ) irrespective of manometry findings .
-METHODS	Those randomized to sphincterotomy with elevated pancreatic sphincter pressures were randomized again ( 1:1 ) to biliary or to both biliary and pancreatic sphincterotomies .
-METHODS	Seventy-two were entered into an observational study with conventional ERCP managemeny .
-METHODS	Success of treatment was defined as less than 6 days of disability due to pain in the prior 90 days both at months 9 and 12 after randomization , with no narcotic use and no further sphincter intervention .
-RESULTS	Twenty-seven patients ( 37 % ; 95 % CI , 25.9 % -48.1 % ) in the sham treatment group vs 32 ( 23 % ; 95 % CI , 15.8 % -29.6 % ) in the sphincterotomy group experienced successful treatment ( adjusted risk difference , -15.6 % ; 95 % CI , -28.0 % to -3.3 % ; P = .01 ) .
-RESULTS	Of the patients with pancreatic sphincter hypertension , 14 ( 30 % ; 95 % CI , 16.7 % -42.9 % ) who underwent dual sphincterotomy and 10 ( 20 % ; 95 % CI , 8.7 % -30.5 % ) who underwent biliary sphincterotomy alone experienced successful treatment .
-RESULTS	Thirty-seven treated patients ( 26 % ; 95 % CI ,19 % -34 % ) and 25 patients ( 34 % ; 95 % CI , 23 % -45 % ) in the sham group underwent repeat ERCP interventions ( P = .22 ) .
-RESULTS	Manometry results were not associated with the outcome .
-RESULTS	No clinical subgroups appeared to benefit from sphincterotomy more than others .
-RESULTS	Pancreatitis occurred in 15 patients ( 11 % ) after primary sphincterotomies and in 11 patients ( 15 % ) in the sham group .
-RESULTS	Of the nonrandomized patients in the observational study group , 5 ( 24 % ; 95 % CI , 6 % -42 % ) who underwent biliary sphincterotomy , 12 ( 31 % ; 95 % CI , 16 % -45 % ) who underwent dual sphincterotomy , and 2 ( 17 % ; 95 % CI , 0 % -38 % ) who did not undergo sphincterotomy had successful treatment .
-CONCLUSIONS	In patients with abdominal pain after cholecystectomy undergoing ERCP with manometry , sphincterotomy vs sham did not reduce disability due to pain .
-CONCLUSIONS	These findings do not support ERCP and sphincterotomy for these patients .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00688662 .
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-###25249300
-BACKGROUND	Glycosylated proteins partake in multiple cellular processes including inflammation .
-BACKGROUND	We hypothesized that GlycA , a novel biomarker of protein glycan N-acetyl groups , is related to incident cardiovascular disease ( CVD ) , and we compared it with high-sensitivity C-reactive protein ( hsCRP ) .
-RESULTS	In 27 491 initially healthy women , baseline GlycA was quantified by nuclear magnetic resonance spectroscopy and hsCRP by an immunoturbidimetric assay .
-RESULTS	During median follow-up of 17.2 years , 1648 incident CVD events occurred ( myocardial infarction , ischemic stroke , coronary revascularization , and CVD death ) .
-RESULTS	GlycA and hsCRP were moderately correlated ( Spearman r = 0.61 , P < 0.0001 ) .
-RESULTS	In Cox regression models that included age , ethnicity , smoking , blood pressure , medications , menopausal status , body mass index , and diabetes , hazard ratios for CVD across quartiles 1 to 4 of GlycA were 1.00 , 1.10 ( 95 % CI , 0.92 to 1.30 ) , 1.34 ( 95 % CI , 1.13 to 1.58 ) , and 1.64 ( 95 % CI , 1.39 to 1.93 ) , similar to hsCRP , for which hazard ratios were 1.00 , 1.18 ( 95 % CI , 0.99 to 1.41 ) , 1.35 ( 95 % CI , 1.14 to 1.61 ) , and 1.75 ( 95 % CI , 1.47 to 2.09 ) ( both Ptrend < 0.0001 ) .
-RESULTS	Associations were attenuated after additionally adjusting for lipids : the hazard ratio of quartile 4 versus 1 for GlycA was 1.23 ( 95 % CI , 1.04 to 1.46 ; Ptrend = 0.002 ) and for hsCRP was 1.44 ( 95 % CI , 1.20 to 1.72 ; Ptrend < 0.0001 ) .
-RESULTS	Further adjustment for the other biomarker resulted in a hazard ratio of quartile 4 versus 1 for GlycA of 1.03 ( 95 % CI , 0.85 to 1.24 ; Ptrend = 0.41 ) and for hsCRP of 1.29 ( 95 % CI , 1.06 to 1.56 ; Ptrend = 0.001 ) .
-CONCLUSIONS	In this prospective study of initially healthy women , baseline GlycA was associated with incident CVD , consistent with a possible role for protein glycans in inflammation and CVD .
-BACKGROUND	http / / clinicaltrials.gov / .
-BACKGROUND	Unique identifier NCT00000479 .
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-###25339518
-BACKGROUND	Rifaximin therapy reduced risk of hepatic encephalopathy ( HE ) recurrence and HE-related hospitalisations during a 6-month , randomised , placebo-controlled trial ( RCT ) and a 24-month open-label maintenance ( OLM ) study .
-BACKGROUND	However , the impact of crossover from placebo to rifaximin therapy is unclear .
-OBJECTIVE	To study the impact of crossing over from placebo to rifaximin treatment on breakthrough HE and hospitalisation rates using a within-subjects design .
-METHODS	Adults with cirrhosis and history of overt HE episodes , currently in HE remission , received placebo during the RCT and crossed over to rifaximin 550mg twice daily during the OLM study .
-METHODS	Rate of breakthrough overt HE episodes , hospitalisations and incidence and rate of adverse events ( AEs ) were analysed during RCT and first 6months of OLM .
-RESULTS	Of 82 patients randomised to placebo in the RCT who crossed over to the OLM study , 39 experienced an HE episode during the RCT compared with 14 during the OLM study ( P < 0.0001 ) .
-RESULTS	Significantly lower rates of HE events were observed with rifaximin treatment compared with placebo treatment ( P < 0.0001 ) .
-RESULTS	Rates of HE-related hospitalisation were numerically lower during rifaximin treatment compared with placebo treatment , although not significant .
-RESULTS	Rates of most common AEs , serious AEs and infection-related AEs were similar between the two treatments .
-CONCLUSIONS	This analysis confirms the repeatability of results from the RCT on safety and efficacy of rifaximin 550mg twice daily in reducing the risk of hepatic encephalopathy recurrence , and suggests these findings are translatable outside of a rigorous , controlled trial setting .
-
-###26078250
-OBJECTIVE	Long-chain polyunsaturated fatty acids ( LC-PUFA ) are regarded as essential for child cognition .
-OBJECTIVE	Genetic variation in fatty acid ( FA ) desaturase enzyme ( FADS ) has been recognized as an important effect modifier in the relation between LC-PUFA and child cognitive function .
-OBJECTIVE	This study aimed to identify the distribution of genetic variant ( genotype ) SNP rs174468 and to assess plasma FA and developmental outcome by the genotype among under-2 year old Sasaknese Indonesian children .
-METHODS	Data was collected at baseline of a randomized trial ( NUPICO , clinicaltrials.gov NCT01504633 ) in East Lombok district , Indonesia .
-METHODS	Breastfed , 12 - 17 month old children were recruited and 240 subjects were included in the study .
-METHODS	Child cognition was assessed as Bayley Mental Developmental Index ( MDI ) .
-RESULTS	From 206 subjects whose blood samples can be collected , only two genotypes were found ( 90.3 % GG homozygotes , 9.7 % AG heterozygotes ) , and minor allele AG was significantly associated with higher level of arachidonic acid ( 20:4 n-6 ) , n-6 LC-PUFA and FADS1 index .
-RESULTS	MDI score was associated with a FADS2 index ( DHA : EPA ratio ) but not genotype ( Adjusted R-square = 0.043 ) .
-CONCLUSIONS	FADS2 index was associated with cognitive function .
-CONCLUSIONS	No difference was found between children with GG and AG genotypes who were all breastfed and not low birth weight .
-
-###24944063
-BACKGROUND	It is important to understand whether eating eggs , which are a major source of dietary choline , results in increased exposure to trimethylamine-N-oxide ( TMAO ) , which is purported to be a risk factor for developing heart disease .
-OBJECTIVE	We determined whether humans eating eggs generate TMAO and , if so , whether there is an associated increase in a marker for inflammation [ ie , high-sensitivity C-reactive protein ( hsCRP ) ] or increased oxidation of low-density lipoprotein ( LDL ) .
-METHODS	In a longitudinal , double-blind , randomized dietary intervention , 6 volunteers were fed breakfast doses of 0 , 1 , 2 , 4 , or 6 egg yolks .
-METHODS	Diets were otherwise controlled on the day before and day of each egg dose with a standardized low-choline menu .
-METHODS	Plasma TMAO at timed intervals ( immediately before and 1 , 2 , 4 , 8 , and 24 h after each dose ) , 24-h urine TMAO , predose and 24-h postdose serum hsCRP , and plasma oxidized LDL were measured .
-METHODS	Volunteers received all 5 doses with each dose separated by > 2-wk washout periods .
-RESULTS	The consumption of eggs was associated with increased plasma and urine TMAO concentrations ( P < 0.01 ) , with 14 % of the total choline in eggs having been converted to TMAO .
-RESULTS	There was considerable variation between individuals in the TMAO response .
-RESULTS	There was no difference in hsCRP or oxidized LDL concentrations after egg doses .
-CONCLUSIONS	The consumption of 2 eggs results in an increased formation of TMAO .
-CONCLUSIONS	Choline is an essential nutrient that is required for normal human liver and muscle functions and important for normal fetal development .
-CONCLUSIONS	Additional study is needed to both confirm the association between TMAO and atherosclerosis and identify factors , microbiota and genetic , that influence the generation of TMAO before policy and medical recommendations are made that suggest reduced dietary choline intake .
-
-###25038486
-OBJECTIVE	Asunaprevir is a selective HCV NS3 protease inhibitor , active against genotypes 1 , 4 , 5 , and 6 in vitro .
-OBJECTIVE	We evaluated asunaprevir plus peginterferon alfa-2a / ribavirin ( PegIFN/RBV ) for genotype 1 and 4 chronic HCV .
-METHODS	In this phase 2b , double-blind , placebo-controlled study , treatment-naive adults with genotype 1 ( n = 213 ) or 4 ( n = 25 ) were randomly assigned ( 3:1 ) to asunaprevir 200mg or placebo twice daily plus PegIFN/RBV .
-METHODS	Asunaprevir recipients , achieving protocol-defined response ( HCV-RNA below quantification limit at week 4 and undetectable at week 10 ) , were rerandomized at week 12 to continue asunaprevir-based triple therapy or receive placebo plus PegIFN/RBV for weeks 13-24 .
-METHODS	Patients without protocol-defined response ( PDR ) and placebo recipients continued PegIFN/RBV through week 48 .
-METHODS	Co-primary end points were undetectable HCV-RNA at week 4 and 12 ( eRVR ) and 24 weeks posttreatment ( SVR24 ) .
-RESULTS	Most patients were male ( 64.3 % ) , white ( 83.6 % ) , and had non-CC IL28B genotypes ( 71.3 % ) .
-RESULTS	Among genotype 1 patients , eRVR rates ( asunaprevir vs. placebo ) were 67 % ( 80 % CI 62 , 72 ) vs. 6 % ( 80 % CI 2 , 10 ) ; corresponding SVR24 rates were 64 % ( 80 % CI 59 , 68 ) vs. 44 % ( 80 % CI 36 , 53 ) .
-RESULTS	SVR24 among genotype 4 patients was 89 % ( asunaprevir ) vs. 43 % ( placebo ) .
-RESULTS	Rates of rash and haematologic adverse events were similar between treatment groups .
-RESULTS	Five asunaprevir-treated patients had grade 4 alanine aminotransferase elevations that resolved following discontinuation ( n = 4 ) or with continued dosing ( n = 1 ) .
-CONCLUSIONS	Addition of asunaprevir to PegIFN/RBV in treatment-naive genotype 1 - or 4-infected patients improves response rates and is well tolerated , with aminotransferase elevations that were manageable with appropriate monitoring .
-CONCLUSIONS	ClinicalTrials.gov ID : NCT01030432 .
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-###24439959
-BACKGROUND	Depersonalization disorder ( DPD ) includes changes in subjective experiencing of self , encompassing emotional numbing .
-BACKGROUND	Functional magnetic resonance imaging ( fMRI ) has pointed to ventrolateral prefrontal cortex ( VLPFC ) inhibition of insula as a neurocognitive correlate of the disorder .
-OBJECTIVE	We hypothesized that inhibition to right VLPFC using repetitive transcranial magnetic stimulation ( rTMS ) would lead to increased arousal and reduced symptoms .
-METHODS	Patients with medication-resistant DSM-IV DPD ( N = 17 ) and controls ( N = 20 ) were randomized to receive one session of right-sided rTMS to VLPFC or temporo-parietal junction ( TPJ ) .
-METHODS	1 Hz rTMS was guided using neuronavigation and delivered for 15 min .
-METHODS	Co-primary outcomes were : ( a ) maximum skin conductance capacity , and ( b ) reduction in depersonalization symptoms ( Cambridge Depersonalisation Scale ( CDS ) [ state version ] ) .
-METHODS	Secondary outcomes included spontaneous fluctuations ( SFs ) and event-related skin conductance responses .
-RESULTS	In patients with DPD , rTMS to VLPFC led to increased electrodermal capacity , namely maximum skin conductance deflections .
-RESULTS	Patients but not controls also showed increased SFs post rTMS .
-RESULTS	Patients who had either VLPFC or TPJ rTMS showed a similar significant reduction in symptoms .
-RESULTS	Event-related electrodermal activity did not change .
-CONCLUSIONS	A single session of right-sided rTMS to VLPFC ( but not TPJ ) significantly increased physiological arousal capacity supporting our model regarding the relevance of increased VLPFC activity to emotional numbing in DPD .
-CONCLUSIONS	rTMS to both sites led to reduced depersonalization scores but since this was independent of physiological arousal , this may be a non-specific effect .
-CONCLUSIONS	TMS is a potential therapeutic option for DPD ; modulation of VLPFC , if replicated , is a plausible mechanism .
-
-###24249853
-OBJECTIVE	To determine whether a college of pharmacy curriculum creates a sense of self-efficacy among students with respect to providing medication therapy management ( MTM ) services .
-METHODS	An electronic survey instrument was sent to all pharmacy students to elicit information on their perceived confidence in providing MTM services , and the results were reviewed .
-RESULTS	Of the 1,160 students targeted , 464 ( 40 % ) completed the survey instrument .
-RESULTS	Responses indicated that overall self-efficacy increased with each successive year of the curriculum that students completed .
-RESULTS	Fourth-year students completing an advanced pharmacy practice experience ( APPE ) in medication therapy management ( MTM ) had significantly higher self-efficacy than did other fourth-year students , whose self-efficacy was similar to that of third-year students .
-RESULTS	conclusion : In this study population , students ' self-efficacy increased with each successive year in pharmacy school , with those who completed an APPE in MTM exhibiting the highest level of self-efficacy .
-RESULTS	These students may be more likely to pursue MTM opportunities in future careers .
-
-###24707612
-OBJECTIVE	To show that patients with intertrochanteric fractures treated with a proximal femoral nail have a better postoperative course than those treated with a DHS plate ( dynamic hip screw ) .
-METHODS	Patients with a Boyd & Griffin type II intertrochanteric fracture were randomly divided into two groups : a group of patients treated with a PFN and another one treated with a DHS plate .
-METHODS	All patients were assessed at 2 , 4 , 8 and 16 weeks using the Harris scale and the visual analog scale pre - and postoperatively , as well as the operative time , incision size , intraoperative bleeding , onset of partial and/or total weight bearing , healing time , time to attain prior physical activity level , and radiographic result .
-RESULTS	32 patients met our criteria .
-RESULTS	The variables that had a significant reduction were : incision , operative time , postoperative pain according to the visual analog scale , onset of mobility , partial weight bearing and pain at 2 weeks .
-CONCLUSIONS	The proximal femoral nail has better short-term outcomes than the DHS plate ; however , in the medium term both implants have the same outcomes .
-
-###25438965
-OBJECTIVE	Completion rate for the three-dose series of the human papillomavirus ( HPV ) vaccine has generally been low .
-OBJECTIVE	This study evaluated the effectiveness of a reminder letter intervention on HPV vaccine three-dose series completion .
-METHODS	Female members of Kaiser Permanente Southern California Health Plan who received at least one dose , but not more than two doses , of the HPV vaccine by February 13 , 2013 , and who were between ages 9 and 26 years at the time of first HPV vaccination were included .
-METHODS	Eighty percent of these females were randomized to receive the reminder letter , and 20 % were randomized to receive standard of care ( control ) .
-METHODS	The reminder letters were mailed quarterly to those who had not completed the series .
-METHODS	The proportion of series completion at the end of the 12-month evaluation period was compared using chi-square test .
-RESULTS	A total of 9,760 females were included in the intervention group and 2,445 in the control group .
-RESULTS	HPV vaccine series completion was 56.4 % in the intervention group and 46.6 % in the control groups ( p < .001 ) .
-RESULTS	The effect of the intervention appeared to be stronger in girls aged 9-17years compared with young women aged 18-26years at the first dose and in blacks compared with whites .
-CONCLUSIONS	Reminder letters scheduled quarterly were effective to enhance HPV vaccine series completion among those who initiated the vaccine .
-CONCLUSIONS	However , a large gap in series completion remained despite the intervention .
-CONCLUSIONS	Future studies should address other barriers to series completion , including those at the providers and the health care system level .
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-###24942481
-OBJECTIVE	To evaluate the cost effectiveness of a behavioural therapy intervention shown to be clinically effective in comparison with usual care for stroke patients with aphasia .
-METHODS	Randomised controlled trial with comparison of costs and calculation of incremental cost effectiveness ratio .
-METHODS	Community .
-METHODS	Participants identified as having low mood on either the Visual Analog Mood Scale sad item ( 50 ) or Stroke Aphasic Depression Questionnaire Hospital version 21 ( SADQH21 ) ( 6 ) were recruited .
-METHODS	Participants were randomly allocated to behavioural therapy or usual care using internet-based randomisation generated in advance of the study by a clinical trials unit .
-METHODS	Outcomes were assessed at six months after randomisation , blind to group allocation .
-METHODS	The costs were assessed from a service use questionnaire .
-METHODS	Effectiveness was defined as the change in SADQH21 scores and a cost-effectiveness analysis was performed comparing the behavioural group with the usual care control group .
-METHODS	The cost analysis was undertaken from the perspective of the UK NHS and Social Services .
-RESULTS	The greatest difference was in home help costs where there was a saving of 56.20 in the intervention group compared to an increase of 61.40 in the control group .
-RESULTS	At six months the SADQH21 score for the intervention group was 17.3 compared to the control group value of 20.4 .
-RESULTS	This resulted in a mean increase of 0.7 in the control group , compared to a mean significant different decrease of 6 in the intervention group ( P = 0.003 ) .
-RESULTS	The Incremental Cost-Effectiveness Ratio indicated that the cost per point reduction on the SADQH21 was 263 .
-CONCLUSIONS	Overall the behavioural therapy was found to improve mood and resulted in some encouraging savings in resource utilisation over the six months follow-up .
-
-###25639198
-OBJECTIVE	This study aimed to compare application of the Mller maneuver ( MM ) and application of drug-induced sleep endoscopy ( DISE ) prior to surgery , in addition to MM , to further ascertain the location of an obstruction in the upper airway and whether the location would change the surgical treatment plan in patients with retropalatal obstruction .
-METHODS	Prospective , clinical trial at a tertiary referral hospital .
-METHODS	This study included 39 obstructive sleep apnea patients who were recommended for surgical treatment .
-METHODS	Patients were randomly divided into two groups : The first group ( DISE plus MM ) underwent a DISE ( 19 patients ) , in addition to the planned procedure according to MM .
-METHODS	Meanwhile , the second group ( MM only ) underwent surgery based only on their MM evaluation ( 20 patients ) .
-METHODS	Patients with retrolingual-localized obstructions were excluded , whereas patients withthird-degree obstructions at the retropalatal level , according to DISE and/or MM , were included in the study .
-RESULTS	There was a significant improvement between pre - and postoperative polysomnography findings in both groups .
-RESULTS	However , the postoperative improvements between the groups were not statistically different .
-RESULTS	Because there was a significant change in the planned surgical procedures in the first group , there were significantly more combined surgeries followed by the DISE procedure .
-CONCLUSIONS	Although the DISE resulted in more changes in the surgical treatment plan and higher rate of combined treatment compared to MM , we determined that this difference did not result in a significant difference in treatment success .
-METHODS	4 .
-
-###24618303
-OBJECTIVE	This study investigated improvements in quality of life associated with eight weeks of montelukast and/or intranasal steroid treatment for moderate to severe allergic rhinitis .
-METHODS	A single-centre , prospective , randomised , double-blind , placebo-controlled study was carried out .
-METHODS	Assessments were made using the Rhinoconjunctivitis Quality of Life Questionnaire and symptom scales .
-RESULTS	A total of 128 patients ( aged 13-51 years ) were randomly assigned to one of two groups .
-RESULTS	In the montelukast group , patients were treated with montelukast tablets and fluticasone propionate nasal spray ( n = 64 ) .
-RESULTS	In the placebo group , treatment comprised a placebo and fluticasone propionate .
-RESULTS	The results showed significant improvements in symptom scores and quality of life scores for both groups after one month and two months of treatment , compared with baseline values ; these improvements were significantly greater for the montelukast group compared with the placebo group .
-RESULTS	The mean number of loratadine tablets taken by each patient during the study period was only 0.73 for the montelukast group compared with 9 for the placebo group .
-CONCLUSIONS	The combination of montelukast tablets and fluticasone propionate nasal spray improved symptom control and overall quality of life for moderate to severe allergic rhinitis patients .
-
-###25609935
-BACKGROUND	Physical rehabilitation is commonly used in patients with Parkinson 's disease ( PD ) to improve their health and alleviate the symptoms .
-OBJECTIVE	We compared the effects of three programs , strength training ( ST ) , aerobic training ( AT ) , and physiotherapy , on motor symptoms , functional capacity , and electroencephalographic ( EEG ) activity in PD patients .
-METHODS	Twenty-two patients were recruited and randomized into three groups : AT ( 70 % of maximum heart rate ) , ST ( 80 % of one repetition maximum ) , and physiotherapy ( in groups ) .
-METHODS	Subjects participated in their respective interventions twice a week for 12 weeks .
-METHODS	The assessments included measures of disease symptoms ( Unified Parkinson 's Disease Rating Scale [ UPDRS ] ) , functional capacity ( Senior Fitness Test ) , and EEG before and after 12 weeks of intervention .
-RESULTS	The PD motor symptoms ( UPDRS-III ) in the group of patients who performed ST and AT improved by 27.5 % ( effect size [ ES ] = 1.25 , confidence interval [ CI ] = -0.11 , 2.25 ) and 35 % ( ES = 1.34 , CI = -0.16 , 2.58 ) , respectively , in contrast to the physiotherapy group , which showed a 2.9 % improvement ( ES = 0.07 , CI = -0.85 , 0.99 ) .
-RESULTS	Furthermore , the functional capacity of all three groups improved after the intervention .
-RESULTS	The mean frequency of the EEG analysis mainly showed the effect of the interventions on the groups ( F = 11.50 , P = 0.0001 ) .
-CONCLUSIONS	ST and AT in patients with PD are associated with improved outcomes in disease symptoms and functional capacity .
-
-###25051390
-OBJECTIVE	The objective of this study is to determine the effects of a caffeine-containing energy drink on female volleyball players ' performance .
-METHODS	Thirteen elite female volleyball players ingested 3 mgkg of caffeine with an energy drink or the same drink without caffeine ( placebo drink ) in a double-blind and randomized study .
-METHODS	Then , participants performed the following : standing spike , jumping spike , spike jump , blocking jump , squat jump , countermovement jump , manual dynamometry , and the agility t-test .
-METHODS	A simulated volleyball game was played , videotaped , and notated afterward .
-RESULTS	In comparison to the placebo drink , the ingestion of the caffeinated energy drink increased the ball velocity in the standing spike ( 19.2 2.1 vs 19.7 1.9 ms , P = 0.023 ) and in the jumping spike ( 17.9 2.2 vs 18.8 2.2 ms , P = 0.038 ) and the jump height in the squat jump ( 28.1 3.2 vs 29.4 3.6 cm , P = 0.028 ) , countermovement jump ( 32.0 4.6 vs 33.1 4.5 cm , P = 0.018 ) , spike jump ( 43.3 4.7 vs 44.4 5.0 cm , P = 0.025 ) , and block jump ( 35.2 5.1 vs 36.1 5.1 cm , P = 0.044 ) .
-RESULTS	Furthermore , the caffeinated energy drink decreased the time needed to complete the agility t-test ( 11.1 0.5 vs 10.9 0.3 s , P = 0.036 ) .
-RESULTS	During the game , the volleyball actions categorized as successful were more frequent with the caffeinated energy drink ( 34 % 9 % vs 45 % 9 % , P < 0.001 ) , whereas imprecise actions decreased ( 28 % 7 % vs 14 % 9 % , P < 0.001 ) when compared with the placebo drink .
-CONCLUSIONS	Commercially available energy drinks can significantly improve physical performance in female volleyball players .
-CONCLUSIONS	Increased physical performance led to improved accuracy during an actual volleyball match .
-
-###24423298
-BACKGROUND	Data on the metabolic effects of GH derived from studies using GH suppression by pharmacological agents may not reflect selective actions .
-OBJECTIVE	The purpose of this study was to evaluate the effects of GH antagonism on glucose and lipid metabolism using pegvisomant , a selective GH receptor antagonist in patients with type 1 diabetes ( T1D ) .
-METHODS	In a randomized , placebo-controlled , crossover study , 10 young adults with T1D were evaluated at baseline and after 4 weeks of treatment with either 10 mg of pegvisomant or placebo .
-METHODS	The assessments included an overnight euglycemic steady state followed by a hyperinsulinemic euglycemic clamp and used glucose and glycerol cold stable isotopes .
-METHODS	Hepatic and peripheral insulin sensitivity ( IS ) , lipid turnover , and intramyocellular lipid ( IMCL ) were measured .
-RESULTS	Compared with placebo , pegvisomant treatment resulted in lower IGF-I levels ( P < .001 ) .
-RESULTS	During the overnight steady state , insulin requirements for euglycemia ( P = .019 ) , insulin levels ( P = .008 ) , and glucose production rates ( Ra ) ( P = .033 ) were reduced .
-RESULTS	During the clamp study , glucose infusion rates ( P = .031 ) increased and glucose Ra ( P = .015 ) decreased whereas glucose disposal rates were unchanged .
-RESULTS	Free fatty acid levels were similar during the steady state but were lower during the clamp ( P = .040 ) after pegvisomant .
-RESULTS	Soleus muscle IMCL decreased after treatment ( P = .024 ) ; however , no change in tibialis anterior muscle was observed .
-CONCLUSIONS	The study demonstrates that GH antagonism in T1D results in improved hepatic insulin sensitivity .
-CONCLUSIONS	Lack of consistent changes in free fatty acid levels may suggest a direct effect of GH on IS .
-CONCLUSIONS	Unchanged peripheral IS despite reductions in IMCL indicate that GH-induced alterations in IMCL may not be causally linked to glucose metabolism .
-
-###25322473
-OBJECTIVE	Patient decision aids have been used in many clinical situations to improve the patient centeredness of care .
-OBJECTIVE	A patient decision aid for patients with posttraumatic stress disorder ( PTSD ) has not been developed or tested .
-OBJECTIVE	The authors evaluated the effects of a patient decision aid on the patient centeredness of PTSD treatment .
-METHODS	The study was a randomized trial of a patient decision aid for PTSD versus treatment as usual ( control group ) .
-METHODS	The participants were 132 male and female veterans who presented to a single U.S. Department of Veterans Affairs hospital with a new diagnosis of PTSD .
-METHODS	Patient centeredness was assessed by knowledge of PTSD and its treatment , level of decisional uncertainty , and ability to state a preferred treatment option .
-METHODS	Secondary outcomes included treatments received and PTSD symptoms in the six months after study entry .
-RESULTS	Compared with the control group ( N = 65 ) , participants who reviewed the patient decision aid ( N = 63 ) had higher scores for PTSD knowledge ( p = .002 ) and less conflict about their choice of treatment ( p = .003 ) .
-RESULTS	In addition , participants who reviewed the patient decision aid were more likely to select and receive an evidence-based treatment for PTSD ( p = .04 ) and had superior PTSD outcomes ( p = .004 ) compared with the control group .
-CONCLUSIONS	Use of a patient decision aid was associated with improvements in patient-centered PTSD treatment .
-CONCLUSIONS	The patient decision aid was also associated with greater use of evidence-based treatments and improvement of PTSD symptoms .
-CONCLUSIONS	This study suggests that clinics should consider using a patient decision aid for patients with PTSD .
-
-###25682480
-BACKGROUND	Cocaine addiction continues to be a significant healthcare issue , yet there are no FDA approved medications for the treatment of cocaine use disorder within the United States .
-METHODS	This 12-week , prospective , double-blind , randomized , placebo-controlled study examined the effectiveness of quetiapine ( Seroquel XR ) versus matched placebo for the treatment of DSM-IV cocaine dependence in non-psychotic individuals .
-METHODS	Subjects randomized to quetiapine ( N = 29 ) were titrated up to a target dose of 400mg/day of quetiapine , while those in the placebo arm ( N = 31 ) were given a matched placebo .
-METHODS	All subjects had weekly clinic visits and a cognitive-behavioral therapy group session .
-METHODS	Outcome measures included self-report of cocaine use and money spent on cocaine as well as urine drug screens ( UDS ) .
-RESULTS	The drop-out rate was substantial at 68 % .
-RESULTS	Logistic regression analysis did not find significant differences between groups in predicting end-of trial abstinence , defined as three consecutive weekly negative UDS ( 13.7 % in the quetiapine group versus 12.9 % in the placebo group ; p = .92 ) .
-RESULTS	Based upon a repeated measures analysis of variance , subjects in this study , as a whole , demonstrated reductions in their self-reported use of cocaine , self-reported money spent on cocaine , and number of days per week using cocaine .
-RESULTS	However , the quetiapine group did not differ significantly from the placebo group .
-CONCLUSIONS	This study did not find group differences between the quetiapine and placebo arms , suggesting that quetiapine is not an efficacious treatment for DSM-IV cocaine dependence .
-
-###25323260
-BACKGROUND	Intraventricular fluid dynamics can be assessed clinically using imaging .
-BACKGROUND	The contribution of vortex structures to left ventricular ( LV ) diastolic function has never been quantified in vivo .
-OBJECTIVE	This study sought to understand the impact of intraventricular flow patterns on filling and to assess whether impaired fluid dynamics may be a source of diastolic dysfunction .
-METHODS	Two-dimensional flow velocity fields from color Doppler echocardiographic sequences were obtained in 20 patients with nonischemic dilated cardiomyopathy ( NIDCM ) , 20 patients with hypertrophic cardiomyopathy ( HCM ) , and 20 control healthy volunteers .
-METHODS	Using a flow decomposition method , we isolated the rotational velocity generated by the vortex ring from the surrounding flow in the left ventricle .
-RESULTS	The vortex was responsible for entering 13 6 % of filling volume in the control group and 19 8 % in the NIDCM group ( p = 0.004 ) , but only 5 5 % in the HCM group ( p < 0.0001 vs. controls ) .
-RESULTS	Favorable vortical effects on intraventricular pressure gradients were observed in the control and NIDCM groups but not in HCM patients .
-RESULTS	Differences in chamber sphericity explained variations in the vortex contribution to filling between groups ( p < 0.005 ) .
-CONCLUSIONS	The diastolic vortex is responsible for entering a significant fraction of LV filling volume at no energetic or pressure cost .
-CONCLUSIONS	Thus , intraventricular fluid mechanics are an important determinant of global chamber LV operative stiffness .
-CONCLUSIONS	Reduced stiffness in NIDCM is partially related to enhanced vorticity .
-CONCLUSIONS	Conversely , impaired vortex generation is an unreported mechanism of diastolic dysfunction in HCM and probably other causes of concentric remodeling .
-
-###24628705
-BACKGROUND	There is growing evidence that Cognitive Simulation Therapy ( CST ) benefits cognition and quality of life of people with dementia , but little is known about the indirect effects of this intervention on family caregivers .
-BACKGROUND	This study sought to investigate the effect of CST on family caregivers general health status of people with dementia living in the community attending the CST intervention .
-METHODS	Eighty-five family caregivers of people with dementia took part in the study .
-METHODS	All the people with dementia received the standard twice weekly seven weeks of the CST intervention plus either 24 weeks of a maintenance CST ( MCST ) intervention or 24 weeks of treatment as usual .
-METHODS	Family caregivers were assessed before and after their relatives the CST programme , and after 3 and 6 months of the MCST programme .
-METHODS	A pre and post CST groups comparison was undertaken to evaluate the open trial first phase and an ANCOVA model used to analyse the maintenance phase with its controlled comparison .
-RESULTS	We found no evidence for a benefit on the family caregiver outcome measures of the intervention before and after CST groups by using a t-test analysis or any significant differences between intervention and control groups for any of the variables considered at any time point ( 3 and 6 month follow up ) .
-CONCLUSIONS	CST seems to have a relatively specific benefit fpr people with dementia that may not carry over to family carers .
-CONCLUSIONS	Future studies need to further explore and compare the effects that CST might bring to family caregivers of people with dementia attending the intervention .
-BACKGROUND	Current Controlled Trials ISRCTN26286067 .
-
-###25524950
-OBJECTIVE	To compare pharmacokinetics ( PK ) and pharmacodynamics ( PD ) of insulin glargine in type 2 diabetes mellitus ( T2DM ) after evening versus morning administration .
-METHODS	Ten T2DM insulin-treated persons were studied during 24-h euglycemic glucose clamp , after glargine injection ( 0.4 units/kg s.c. ) , either in the evening ( 2200 h ) or the morning ( 1000 h ) .
-RESULTS	The 24-h glucose infusion rate area under the curve ( AUC0-24h ) was similar in the evening and morning studies ( 1,058 571 and 995 691 mg/kg 24 h , P = 0.503 ) , but the first 12 h ( AUC0-12h ) was lower with evening versus morning glargine ( 357 244 vs. 593 374 mg/kg 12 h , P = 0.004 ) , whereas the opposite occurred for the second 12 h ( AUC12-24h 700 396 vs. 403 343 mg/kg 24 h , P = 0.002 ) .
-RESULTS	The glucose infusion rate differences were totally accounted for by different rates of endogenous glucose production , not utilization .
-RESULTS	Plasma insulin and C-peptide levels did not differ in evening versus morning studies .
-RESULTS	Plasma glucagon levels ( AUC0-24h 1,533 656 vs. 1,120 344 ng/L/h , P = 0.027 ) and lipolysis ( free fatty acid AUC0-24h 7.5 1.6 vs. 8.9 1.9 mmol/L/h , P = 0.005 ; - OH-butyrate AUC0-24h 6.8 4.7 vs. 17.0 11.9 mmol/L/h , P = 0.005 ; glycerol , P < 0.020 ) were overall more suppressed after evening versus morning glargine administration .
-CONCLUSIONS	The PD of insulin glargine differs depending on time of administration .
-CONCLUSIONS	With morning administration insulin activity is greater in the first 0-12 h , while with evening administration the activity is greater in the 12-24 h period following dosing .
-CONCLUSIONS	However , glargine PK and plasma C-peptide levels were similar , as well as glargine PD when analyzed by 24-h clock time independent of the time of administration .
-CONCLUSIONS	Thus , the results reflect the impact of circadian changes in insulin sensitivity in T2DM ( lower in the night-early morning vs. afternoon hours ) rather than glargine per se .
-
-###25419615
-OBJECTIVE	Varicella-zoster virus ( VZV ) infections increasingly are reported in patients with multiple sclerosis ( MS ) and constitute an area of significant concern , especially with the advent of more disease-modifying treatments in MS that affect T-cell-mediated immunity .
-OBJECTIVE	To assess the incidence , risk factors , and clinical characteristics of VZV infections in fingolimod-treated patients and provide recommendations for prevention and management .
-METHODS	Rates of VZV infections in fingolimod clinical trials are based on pooled data from the completed controlled phases 2 and 3 studies ( 3916 participants ) and ongoing uncontrolled extension phases ( 3553 participants ) .
-METHODS	Male and female patients aged 18 through 55 years ( 18-60 years for the phase 2 studies ) and diagnosed as having relapsing-remitting MS were eligible to participate in these studies .
-METHODS	In the postmarketing setting , reporting rates since 2010 were evaluated .
-METHODS	In clinical trials , patients received fingolimod at a dosage of 0.5 or 1.25 mg/d , interferon beta-1a , or placebo .
-METHODS	In the postmarketing setting , all patients received fingolimod , 0.5 mg/d ( total exposure of 54,000 patient-years at the time of analysis ) .
-METHODS	Calculation of the incidence rate of VZV infection per 1000 patient-years was based on the reporting of adverse events in the trials and the postmarketing setting .
-RESULTS	Overall , in clinical trials , VZV rates of infection were low but higher with fingolimod compared with placebo ( 11 vs 6 per 1000 patient-years ) .
-RESULTS	A similar rate was confirmed in the ongoing extension studies .
-RESULTS	Rates reported in the postmarketing settings were comparable ( 7 per 1000 patient-years ) and remained stable over time .
-RESULTS	Disproportionality in reporting herpes zoster infection was higher for patients receiving fingolimod compared with those receiving other disease-modifying treatments ( empirical Bayes geometric mean , 2.57 [ 90 % CI , 2.26-2 .91 ] ) ; the proportion of serious herpes zoster infections was not higher than the proportion for other treatments ( empirical Bayes geometric mean , 1.88 [ 90 % CI , 0.87-3 .70 ] ) .
-RESULTS	Corticosteroid treatment for relapses might be a risk factor for VZV reactivation .
-CONCLUSIONS	Rates of VZV infections in clinical trials were low with fingolimod , 0.5 mg/d , but higher than in placebo recipients .
-CONCLUSIONS	Rates reported in the postmarketing setting are comparable .
-CONCLUSIONS	We found no sign of risk accumulation with longer exposure .
-CONCLUSIONS	Serious or complicated cases of herpes zoster were uncommon .
-CONCLUSIONS	We recommend establishing the patient 's VZV immune status before initiating fingolimod therapy and immunization for patients susceptible to primary VZV infection .
-CONCLUSIONS	Routine antiviral prophylaxis is not needed , but using concomitant pulsed corticosteroid therapy beyond 3 to 5 days requires an individual risk-benefit assessment .
-CONCLUSIONS	Vigilance to identify early VZV symptoms is important to allow timely antiviral treatment .
-
-###25286782
-OBJECTIVE	Administration of many drugs including magnesium sulfate ( MS ) has considerable influences on pregnancy outcomes .
-OBJECTIVE	The present study investigates the effects of MS administration on reaching the active phase of labor in women with premature rupture of membrane ( PROM ) and subsequent fetal complications .
-METHODS	A double blind , randomized , placebo-controlled trial was performed among primipara women referred to the PROM center in Tehran , Iran between March 2010 and August 2012 .
-METHODS	Patients were equally allocated into two groups ; the intervention group who received MS ( n = 46 ) and the control ( placebo ) group ( n = 46 ) .
-METHODS	Both groups received a corticosteroid , 1g oral azithromycin ( oral ) and 2 g ampicillin ( IV ) every 6 hours for 48 hours , followed by amoxicillin ( 500 mg orally 3 times daily ) for an additional 5 days .
-METHODS	None of the research staff were aware of the treatment allocation of patients in order for blinding purposes .
-RESULTS	Administration of MS in intervention group increases this period 2.7 times compared to the control group .
-RESULTS	In women whose gestational age was < 30 weeks , MS administration increased the active phase of labor up to 77 % .
-RESULTS	Administration of magnesium sulfate reduced the risk of respiratory distress syndrome significantly ( p = 0 .002 ) , without producing any adverse pregnancy outcomes .
-CONCLUSIONS	Magnesium sulfate increases delay in reaching the active phase of labor in mothers with PROM , without producing adverse birth outcomes .
-CONCLUSIONS	( Registration ID in IRCT ; IRCT2012091810876N1 ) .
-
-###25096690
-OBJECTIVE	The United States has invested substantially in screening and brief intervention for illicit drug use and prescription drug misuse , based in part on evidence of efficacy for unhealthy alcohol use .
-OBJECTIVE	However , it is not a recommended universal preventive service in primary care because of lack of evidence of efficacy .
-OBJECTIVE	To test the efficacy of 2 brief counseling interventions for unhealthy drug use ( any illicit drug use or prescription drug misuse ) - a brief negotiated interview ( BNI ) and an adaptation of motivational interviewing ( MOTIV ) - compared with no brief intervention .
-METHODS	This 3-group randomized trial took place at an urban hospital-based primary care internal medicine practice ; 528 adult primary care patients with drug use ( Alcohol , Smoking , and Substance Involvement Screening Test [ ASSIST ] substance-specific scores of 4 ) were identified by screening between June 2009 and January 2012 in Boston , Massachusetts .
-METHODS	Two interventions were tested : the BNI is a 10 - to 15-minute structured interview conducted by health educators ; the MOTIV is a 30 - to 45-minute intervention based on motivational interviewing with a 20 - to 30-minute booster conducted by master 's - level counselors .
-METHODS	All study participants received a written list of substance use disorder treatment and mutual help resources .
-METHODS	Primary outcome was number of days of use in the past 30 days of the self-identified main drug as determined by a validated calendar method at 6 months .
-METHODS	Secondary outcomes included other self-reported measures of drug use , drug use according to hair testing , ASSIST scores ( severity ) , drug use consequences , unsafe sex , mutual help meeting attendance , and health care utilization .
-RESULTS	At baseline , 63 % of participants reported their main drug was marijuana , 19 % cocaine , and 17 % opioids .
-RESULTS	At 6 months , 98 % completed follow-up .
-RESULTS	Mean adjusted number of days using the main drug at 6 months was 12 for no brief intervention vs 11 for the BNI group ( incidence rate ratio [ IRR ] , 0.97 ; 95 % CI , 0.77-1 .22 ) and 12 for the MOTIV group ( IRR , 1.05 ; 95 % CI , 0.84-1 .32 ; P = .81 for both comparisons vs no brief intervention ) .
-RESULTS	There were also no significant effects of BNI or MOTIV on any other outcome or in analyses stratified by main drug or drug use severity .
-CONCLUSIONS	Brief intervention did not have efficacy for decreasing unhealthy drug use in primary care patients identified by screening .
-CONCLUSIONS	These results do not support widespread implementation of illicit drug use and prescription drug misuse screening and brief intervention .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00876941 .
-
-###24467642
-OBJECTIVE	Increasing life expectancy of HIV-1-infected patients raises interest in how trial results apply to older patients .
-OBJECTIVE	This post-hoc analysis evaluated potential differences in efficacy and safety in older ( 50 years ) versus younger ( < 50 years ) patients in the ECHO and THRIVE trials over 96 weeks .
-METHODS	HIV-infected , treatment-nave adults were randomized to receive rilpivirine ( RPV ) or efavirenz ( EFV ) , plus a background regimen .
-METHODS	Virologic response rates ( FDA snapshot analysis ; HIV-1 RNA < 50 copies/mL ) were assessed at Week 96 .
-METHODS	Total-body bone mineral density was evaluated at baseline and Week 96 by dual-energy X-ray absorptiometry scans .
-METHODS	Serum concentrations of 25-hydroxy vitamin D ( ECHO trial only ) were also measured at baseline , Week 24 and Week 48 .
-RESULTS	1368 patients were treated .
-RESULTS	At Week 96 , virologic response rates were similar between older ( 77 % ) and younger ( 76 % ) RPV-treated patients and numerically higher in older ( 84 % ) versus younger ( 76 % ) EFV-treated patients .
-RESULTS	No clinically relevant age-related differences were observed in immunologic responses .
-RESULTS	Small differences were noted in older versus younger patients in adverse events ( higher rates of depression , insomnia , and rash in older EFV-treated patients ) , laboratory abnormalities ( increased low-density lipoprotein cholesterol and hyperglycemia in older EFV-treated patients and increased amylase in older patients across treatments ) , bone mineral density ( larger decreases in older patients across treatments ) , and progression to severe vitamin D deficiency ( greater in older versus younger EFV-treated patients ) .
-CONCLUSIONS	Efficacy and safety outcomes were generally similar in older versus younger patients in the ECHO and THRIVE trials .
-
-###25253679
-BACKGROUND	Although Muslim diabetic patients may be aware of their religious exemption from fasting , many still fast and adjust their medication regimens accordingly .
-BACKGROUND	Pharmacists have a significant potential to identify and prevent harm from medication misuse in Ramadan .
-OBJECTIVE	This study examines Egyptian pharmacists ' knowledge regarding management of diabetes during Ramadan .
-OBJECTIVE	It also explores pharmacists ' willingness to attend a 1 day workshop on medication regimen adjustment during Ramadan .
-METHODS	Community pharmacies throughout Alexandria , Egypt .
-METHODS	A cross-sectional study using a pretested self-administered survey was conducted among a random sample of community pharmacists .
-METHODS	The survey included three knowledge questions relevant to counseling diabetic patients during Ramadan .
-METHODS	Questions covered the recommended timing and dosing for metformin and insulin as well as the safe blood glucose range required for diabetic patients to safely continue their fast .
-METHODS	Using logistic regression , a model was estimated to predict pharmacists ' willingness to attend a workshop on the adjustment of medication regimens during Ramadan .
-METHODS	Content analysis was used to analyze pharmacists ' answers to the question concerning what they would like the workshop to cover .
-METHODS	Pharmacists ' aggregate scores for all three diabetes management knowledge questions and pharmacists ' willingness to attend a workshop on the adjustment of medication regimens during Ramadan .
-RESULTS	Ninety three percent of the 298 approached pharmacists agreed to participate .
-RESULTS	Forty three pharmacists ( 15.9 % ) did not know the correct answer to any question , 118 ( 43.7 % ) 24 answered one correctly , 86 ( 31.9 % ) answered two correctly and only 23 ( 8.5 % ) answered all 25 three correctly .
-RESULTS	Confidence in therapeutic knowledge regarding medication regimen 26 adjustment during Ramadan was not associated with the pharmacists ' knowledge of diabetes management during Ramadan .
-RESULTS	One hundred seventy five ( 63.6 % ) pharmacists wanted to attend a workshop on adjusting medication regimens during Ramadan .
-RESULTS	This was significantly associated with pharmacists being Muslim ( OR 3.52 , CI 1.70-7 .27 ) and of younger age ( OR 30 = 0.98 , CI 0.96-0 .99978 ) .
-RESULTS	Pharmacists offered specific content and communication process 31 suggestions for the workshop content .
-CONCLUSIONS	This study identifies variability among community pharmacists ' knowledge of diabetes management during Ramadan .
-CONCLUSIONS	It also shows willingness among the majority of pharmacists to learn more about the topic .
-
-###24858202
-OBJECTIVE	Data regarding long-term outcomes of neonates reaching viability following early preterm premature rupture of membranes ( PPROM ; < 25.0 weeks at rupture ) are limited .
-OBJECTIVE	We hypothesized that babies delivered after early PPROM would have increased rates of major childhood morbidity compared with those with later PPROM ( 25.0 weeks at rupture ) .
-METHODS	This was a secondary analysis of a multicenter randomized controlled trial of magnesium sulfate vs placebo for cerebral palsy prevention .
-METHODS	Women with singletons and PPROM of 15-32 weeks were included .
-METHODS	All women delivered at 24.0 weeks or longer .
-METHODS	Those with PPROM less than 25.0 weeks ( cases ) were compared with women with PPROM at 25.0-31 .9 weeks ( controls ) .
-METHODS	Composite severe neonatal morbidity ( sepsis , severe intraventricular hemorrhage , periventricular leukomalacia , severe necrotizing enterocolitis , bronchopulmonary dysplasia , and/or death ) and composite severe childhood morbidity at age 2 years ( moderate or severe cerebral palsy and/or Bayley II Infant and Toddler Development scores greater than 2 SD below the mean ) were compared .
-RESULTS	A total of 1531 women ( 275 early PPROM cases ) were included .
-RESULTS	Demographics were similar between the groups .
-RESULTS	Cases delivered earlier ( 26.6 vs 30.1 weeks , P < .001 ) and had a longer rupture-to-delivery interval ( 20.0 vs 10.4 days , P < .001 ) .
-RESULTS	Case neonates had high rates of severe composite neonatal morbidity ( 75.6 % vs 21.8 % , P < .001 ) .
-RESULTS	Children with early PPROM had higher composite severe childhood morbidity ( 51.6 % vs 22.5 % , P < .001 ) .
-RESULTS	Early PPROM remained associated with composite severe childhood morbidity in multivariable models , even when controlling for delivery gestational age and other confounders .
-CONCLUSIONS	Early PPROM is associated with high rates of neonatal morbidity .
-CONCLUSIONS	Early childhood outcomes at age 2 years remain poor compared with those delivered after later PPROM .
-
-###24316517
-OBJECTIVE	Obesity has been associated with changes in the composition and function of the intestinal microbiota .
-OBJECTIVE	Modulation of the microbiota by antibiotics also alters bile acid and glucose metabolism in mice .
-OBJECTIVE	Hence , we hypothesized that short term administration of oral antibiotics in humans would affect fecal microbiota composition and subsequently bile acid and glucose metabolism .
-METHODS	In this single blinded randomized controlled trial , 20 male obese subjects with metabolic syndrome were randomized to 7 days of amoxicillin 500 mg t.i.d. or 7 days of vancomycin 500 mg t.i.d.
-METHODS	At baseline and after 1 week of therapy , fecal microbiota composition ( Human Intestinal Tract Chip phylogenetic microarray ) , fecal and plasma bile acid concentrations as well as insulin sensitivity ( hyperinsulinemic euglycemic clamp using [ 6,6 - ( 2 ) H2 ] - glucose tracer ) were measured .
-RESULTS	Vancomycin reduced fecal microbial diversity with a decrease of gram-positive bacteria ( mainly Firmicutes ) and a compensatory increase in gram-negative bacteria ( mainly Proteobacteria ) .
-RESULTS	Concomitantly , vancomycin decreased fecal secondary bile acids with a simultaneous postprandial increase in primary bile acids in plasma ( p < 0.05 ) .
-RESULTS	Moreover , changes in fecal bile acid concentrations were predominantly associated with altered Firmicutes .
-RESULTS	Finally , administration of vancomycin decreased peripheral insulin sensitivity ( p < 0.05 ) .
-RESULTS	Amoxicillin did not affect any of these parameters .
-CONCLUSIONS	Oral administration of vancomycin significantly impacts host physiology by decreasing intestinal microbiota diversity , bile acid dehydroxylation and peripheral insulin sensitivity in subjects with metabolic syndrome .
-CONCLUSIONS	These data show that intestinal microbiota , particularly of the Firmicutes phylum contributes to bile acid and glucose metabolism in humans .
-CONCLUSIONS	This trial is registered at the Dutch Trial Register ( NTR2566 ) .
-
-###25198265
-OBJECTIVE	To evaluate whether ondansetron or the combination of doxylamine and pyridoxine was superior for the treatment of nausea and vomiting of pregnancy .
-METHODS	This was a double-blind , randomized , controlled trial in which women with nausea and vomiting of pregnancy were assigned to 4 mg of ondansetron plus a placebo tablet or 25 mg pyridoxine plus 12.5 mg of doxylamine for 5 days .
-METHODS	The primary outcome was an improvement in nausea as reported on a 100-mm visual analog scale ( VAS ) .
-METHODS	Secondary outcomes were a reduction in vomiting on the VAS and the proportion of patients reporting sedation or constipation while using either study regimen .
-RESULTS	Thirty-six women ( 18 in each group ) were randomized to either ondansetron or pyridoxine and doxylamine , of whom 13 ( 72 % ) and 17 ( 94 % ) completed follow-up , respectively .
-RESULTS	There were no differences among the groups with regard to demographic characteristics or baseline nausea .
-RESULTS	Patients randomized to ondansetron were more likely to have an improvement in their baseline nausea as compared with those using pyridoxine and doxylamine over the course of 5 days of treatment ( median VAS score decreased 51 mm [ interquartile range 37-64 ] compared with 20 mm [ 8-51 ] ; P = .019 ) .
-RESULTS	Furthermore , women using ondansetron reported less vomiting ( median VAS decreased 41 [ interquartile range 17-57 ] compared with 17 [ -4 to 38 ] ; P = .049 ) .
-RESULTS	There was no significant difference between the groups regarding sedation or constipation .
-CONCLUSIONS	Our investigation showed ondansetron to be superior to the combination of pyridoxine and doxylamine in the treatment of nausea and emesis in pregnancy .
-BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01668069 .
-METHODS	: I.
-
-###24290345
-OBJECTIVE	Patients with diarrhoea during enteral nutrition ( EN ) have been shown to have low faecal bifidobacteria concentrations .
-OBJECTIVE	Oligofructose/inulin selectively stimulate the growth of bifidobacteria in healthy humans .
-OBJECTIVE	This study investigates the effect of additional oligofructose/inulin on the gastrointestinal microbiota , short-chain fatty acids ( SCFA ) and faecal output in patients receiving EN .
-METHODS	Adult patients in the intensive care unit ( ICU ) who were starting EN with a formula containing fibre were randomised to receive 7g/d of additional oligofructose/inulin or an identically packaged placebo ( maltodextrin ) .
-METHODS	A fresh faecal sample was collected at baseline and following at least 7 days of supplementation .
-METHODS	Faecal microbiota were analysed using fluorescent in-situ hybridisation and faecal output was monitored daily .
-RESULTS	Twenty-two patients ( mean age 71 years ) completed at least 7 days of intervention ( mean 12 days ) .
-RESULTS	At the end of the intervention , there were no significant differences in the concentrations of bifidobacteria between the groups , after adjusting for baseline values ( oligofructose/inulin 6.9 +1.4 , placebo 7.8 +1.3 log10cells/g dry faeces , P > 0.05 ) , but there were significantly lower concentrations of Faecalibacterium prausnitzii ( 7.0 +1.0 vs. 8.4 +1.3 log10cells/g , P = 0.01 ) and Bacteroides-Prevotella ( 9.1 +1.0 vs. 9.9 +0.9 log10cells/g , P = 0.05 ) in patients receiving additional oligofructose/inulin .
-RESULTS	There were no differences in faecal concentrations of any SCFA , secretory IgA , daily faecal score or incidence of diarrhoea between the two groups .
-CONCLUSIONS	Additional oligofructose/inulin did not increase faecal bifidobacteria in critically ill patients receiving EN , although it did result in lower concentrations of F.prausnitzii and Bacteroides-Prevotella .
-CONCLUSIONS	This trial is registered at http://controlled-trials.com .
-CONCLUSIONS	Identifier : ISRCTN06446184 .
-
-###25118263
-OBJECTIVE	To quantify the visual functional changes caused by pinhole glasses .
-METHODS	Healthy subjects underwent ophthalmic examinations including uncorrected distance visual acuity ( UDVA ) and corrected near visual acuity ( CNVA ) , pupil size , depth of focus ( DOF ) , accommodative amplitude , visual field ( VF ) test , contrast sensitivity ( CS ) , and stereopsis .
-METHODS	Subjects underwent the same examinations while wearing pinhole glasses 1 week later .
-RESULTS	Forty-eight eyes of 48 subjects ( 24 male and 24 female ) with a mean age of 35.56.7 years and a mean spherical equivalent of -2.43.3 diopters ( D ) were enrolled .
-RESULTS	The pinhole glasses significantly improved UDVA and CNVA ( logMAR ) from 0.440.46 and 0.260.40 to 0.190.25 and 0.140.22 , respectively .
-RESULTS	The pinhole glasses markedly enlarged pupils from 3.60.5 mm photopic size to 6.00.5 mm , very close to the mesopic size of 6.20.6 mm .
-RESULTS	Mean DOF and accommodative amplitude also significantly increased by approximately 50 % , while VF featured a general reduction of sensitivity .
-RESULTS	Mean deviation ( MD ) significantly decreased from -0.481.57 to -4.221.66 dB , and visual field index ( VFI ) decreased from 99.40.7 % to 98.41.3 % .
-RESULTS	The CS decreased significantly at all four spatial frequencies , and stereopsis deteriorated with pinhole glasses .
-CONCLUSIONS	The pinhole glasses improved visual acuity , DOF , and accommodative amplitude ; however , they resulted in decreased visual quality including general reduction of VF sensitivity , CS , and stereopsis .
-CONCLUSIONS	Therefore , particular attention is needed when wearing pinhole glasses while driving , playing sports , or working with instruments .
-CONCLUSIONS	( ClinicalTrials.gov number , NCT02111356 . )
-
-###24262496
-OBJECTIVE	We compared slow vs fast shock wave frequency rates in disintegration of pediatric renal stones less than 20 mm .
-METHODS	Our study included 60 children with solitary 10 to 20 mm radiopaque renal stones treated with shock wave lithotripsy .
-METHODS	Patients were prospectively randomized into 2 groups , ie those undergoing lithotripsy at a rate of 80 shock waves per minute ( group 1 , 30 patients ) and those undergoing lithotripsy at a rate of 120 shock waves per minute ( group 2 , 30 patients ) .
-METHODS	The 2 groups were compared in terms of treatment success , anesthesia time , secondary procedures and efficiency quotient .
-RESULTS	Stone clearance rate was significantly higher in group 1 ( 90 % ) than in group 2 ( 73.3 % , p = 0.025 ) .
-RESULTS	A total of 18 patients in group 1 ( 60 % ) were rendered stone-free after 1 session , 8 required 2 sessions and 1 needed 3 sessions , while shock wave lithotripsy failed in 3 patients .
-RESULTS	By comparison , 8 patients ( 26.6 % ) in group 2 were rendered stone-free after 1 session , 10 ( 33.3 % ) required 2 sessions and 4 ( 13.3 % ) needed 3 sessions to become stone-free .
-RESULTS	Mean general anesthesia time was significantly longer in group 1 ( p = 0.041 ) .
-RESULTS	Postoperatively 2 patients in group 1 and 4 in group 2 suffered low grade fever ( Clavien grade II ) .
-RESULTS	Significantly more secondary procedures ( percutaneous nephrolithotomy , repeat shock wave lithotripsy ) were required in group 2 ( p = 0.005 ) .
-RESULTS	The predominant stone analysis was calcium oxalate dihydrate in both groups .
-RESULTS	Efficiency quotient was 0.5869 and 0.3437 for group 1 and group 2 , respectively ( p = 0.0247 ) .
-CONCLUSIONS	In children with renal stones slow delivery rates of shock wave lithotripsy have better results regarding stone clearance than fast delivery rates .
-
-###24424249
-OBJECTIVE	To assess time to first achievement of clinically significant visual acuity ( VA ) gains from baseline in patients with retinal vein occlusion ( RVO ) receiving ranibizumab versus sham treatment .
-METHODS	Post hoc analyses of 2 phase 3 clinical trials assessing efficacy and safety of ranibizumab in patients with branch RVO ( Ranibizumab for the Treatment of Macular Edema following Branch Retinal Vein Occlusion : Evaluation of Efficacy and Safety [ BRAVO ] study ; NCT00061594 ) and central RVO ( Ranibizumab for the Treatment of Macular Edema after Central Retinal Vein Occlusion Study : Evaluation of Efficacy and Safety [ CRUISE ] ; NCT00056836 ) over 12 months .
-METHODS	Seven hundred eighty-nine patients ( BRAVO , n = 397 ; CRUISE , n = 392 ) .
-METHODS	Randomization to monthly intraocular ranibizumab injections ( 0.3 mg/0 .5 mg ) or sham .
-METHODS	After 6 monthly injections ( treatment period ) , patients meeting prespecified criteria received as-needed ( pro re nata [ PRN ] ) ranibizumab at their assigned dose ( sham patients , ranibizumab 0.5 mg ) through month 12 ( observation period ) .
-METHODS	BRAVO patients meeting specific eligibility criteria could receive rescue laser treatment once during the treatment and once during the observation periods .
-METHODS	Time to first gain of 15 letters or more from baseline , analyzed using Kaplan-Meier methods .
-METHODS	To evaluate the effect of delaying ranibizumab treatment , sham patients ' VA data also were analyzed , with month 6 considered as baseline to assess vision gains during the 6 months of receiving ranibizumab PRN .
-RESULTS	Median time to first 15-letter or more gain from baseline was 12.0 ( sham ) , 4.8 ( ranibizumab 0.3 mg ) , and 4.0 months ( ranibizumab 0.5 mg ) in BRAVO and 12.2 , 5.9 , and 5.2 months , respectively , in CRUISE .
-RESULTS	The cumulative proportion of patients who had ever gained 15 letters or more from baseline by month 12 was 50 % ( sham ) , 68 % ( ranibizumab 0.3 mg ) , and 71 % ( ranibizumab 0.5 mg ) in BRAVO and 42 % , 61 % , and 66 % , respectively , in CRUISE .
-RESULTS	After 6 months of ranibizumab PRN treatment , a cumulative 10.8 % ( BRAVO ) and 26.2 % ( CRUISE ) of initially sham-treated patients ever gained 15 letters or more .
-CONCLUSIONS	This retrospective analysis shows that more than 50 % of patients treated with monthly ranibizumab achieved clinically significant vision gains during the initial 6 months of treatment , which largely were maintained using PRN treatment to 12 months .
-CONCLUSIONS	In comparison , less than 50 % of patients initially randomized to sham ( and later receiving ranibizumab 0.5 mg PRN treatment ) ever achieved clinically significant vision gains .
-CONCLUSIONS	These results suggest that initiating treatment immediately after diagnosis may provide the greatest vision gains .
-CONCLUSIONS	The potential benefits of early treatment should be evaluated further in prospective clinical studies .
-
-###24604110
-BACKGROUND	Although some clinical reports suggest patient-specific instrumentation in TKA may improve alignment , reduce surgical time , and lower hospital costs , it is unknown whether it improves pain - and function-related outcomes and gait .
-OBJECTIVE	We hypothesized that TKA performed with patient-specific instrumentation would improve patient-reported outcomes measured by validated scoring tools and level gait as ascertained with three-dimensional ( 3-D ) analysis compared with conventional instrumentation 3 months after surgery .
-METHODS	We randomized 40 patients into two groups using either patient-specific instrumentation or conventional instrumentation .
-METHODS	Patients were evaluated preoperatively and 3 months after surgery .
-METHODS	Assessment tools included subjective functional outcome and quality-of-life ( QOL ) scores using validated questionnaires ( New Knee Society Score ( ) [ KSS ] , Knee Injury and Osteoarthritis Outcome Score [ KOOS ] , and SF-12 ) .
-METHODS	In addition , gait analysis was evaluated with a 3-D system during level walking .
-METHODS	The study was powered a priori at 90 % to detect a difference in walking speed of 0.1 m/second , which was considered a clinically important difference , and in a post hoc analysis at 80 % to detect a difference of 10 points in KSS .
-RESULTS	There were improvements from preoperatively to 3 months postoperatively in functional scores , QOL , and knee kinematic and kinetic gait parameters during level walking .
-RESULTS	However , there was no difference between the patient-specific instrumentation and conventional instrumentation groups in KSS , KOOS , SF-12 , or 3-D gait parameters .
-CONCLUSIONS	Our observations suggest that patient-specific instrumentation does not confer a substantial advantage in early functional or gait outcomes after TKA .
-CONCLUSIONS	It is possible that differences may emerge , and this study does not allow one to predict any additional variances in the intermediate followup period from 6 months to 1 year postoperatively .
-CONCLUSIONS	However , the goals of the study were to investigate the recovery period as early pain and functional outcomes are becoming increasingly important to patients and surgeons .
-METHODS	Level I , therapeutic study .
-METHODS	See the Instructions to Authors for a complete description of levels of evidence .
-
-###25434316
-OBJECTIVE	Inadequate bowel cleaning leads to a suboptimal colonoscopic examination .
-OBJECTIVE	Gum chewing has been reported to have a favorable effect on postoperative bowel functions .
-OBJECTIVE	We conducted this study to establish if gum chewing added to high-dose senna before colonoscopy promotes bowel cleaning .
-METHODS	In this randomized controlled study , consecutive outpatients scheduled for elective colonoscopy were randomized into two groups .
-METHODS	Group 1 patients ( n = 65 ) used senna solution 150 mL ( 300 mg senna ) the night before colonoscopy .
-METHODS	The patients also used sennoside tablet 80 mg daily for 3 days before the colonoscopy .
-METHODS	Patients in group 2 ( n = 64 ) were additionally advised to chew sugarless gum half an hour three-times daily after meals for these 3 days .
-METHODS	The overall quality of colonoscopy cleaning was evaluated using the Aronchick scale by a single endoscopist who was blinded to the intervention .
-METHODS	Difficulty of procedure , patients ' tolerance , and adverse events were also evaluated .
-RESULTS	A total 129 patients were enrolled in the study .
-RESULTS	Superior cleaning was found in gum chewing group when compared with other group particularly in the cecum and ascending colon .
-RESULTS	Cecal intubation time was significantly shorter in the gum-chewing group ( 8.6 5.1 and 7.1 2.8 min , P = 0.03 ) .
-RESULTS	Adverse events were more common in group 1 compared to the gum-chewing group .
-CONCLUSIONS	Gum chewing enhances colonoscopy bowel preparation quality .
-CONCLUSIONS	Moreover , it is a physiologically sound , safe , and an inexpensive part of the colonoscopy bowel preparation .
-CONCLUSIONS	Gum chewing could be advised in addition to high-dose senna containing bowel preparation .
-
-###24343961
-BACKGROUND	Individuals with borderline personality disorder ( BPD ) and comorbid post-traumatic stress disorder ( PTSD ) have a worse prognosis than individuals with BPD alone .
-BACKGROUND	A common view is that the emotional instability and impulsivity of BPD should be treated before attempting to address trauma .
-BACKGROUND	However , PTSD symptoms may interfere with patients ' ability to benefit from such ` stabilizing ' treatments .
-METHODS	The effect of BPD-PTSD comorbidity on self-harm and BPD symptom outcomes was evaluated in 89 patients receiving dialectical behaviour therapy , using multilevel modelling .
-RESULTS	Patients with comorbid BPD-PTSD showed a trend towards elevated BPD symptoms throughout the treatment year ( = 2.12 , 95 % CI = -0.21 -4.44 , p = 0.07 ) .
-RESULTS	There was a three-way interaction between PTSD comorbidity , treatment completion and time , whereby PTSD comorbidity was associated with less reduction in self-harm frequency over time , but only in those completing the full 12 months of treatment ( incident risk ratio = 1.16 , 95 % CI = 1.04-1 .30 , p < 0.01 ) .
-CONCLUSIONS	Patients with comorbid PTSD had a poorer outcome from dialectical behaviour therapy than those with BPD alone , possibly because of the negative impact of unaddressed trauma .
-CONCLUSIONS	The results provide further grounds for recently developed treatments targeting BPD traits and PTSD symptoms simultaneously .
-
-###24958577
-BACKGROUND	Response-dose ratio ( RDR ) and cumulative provocative dosage ( PD ) are useful indices reflecting airway responsiveness in asthma .
-OBJECTIVE	To compare the diagnostic value of RDR and PD , by conducting leukotriene D4 ( LTD4-BPT ) and methacholine bronchial provocation test ( MCh-BPT ) , in different asthma control levels .
-METHODS	Healthy subjects and asthmatic patients underwent LTD4-BPT and MCh-BPT , at 2-14-day interval .
-METHODS	This entailed assessment of the distribution characteristics , correlation , and diagnostic value of PD inducing 20 % fall in forced expiratory volume in one second ( PD20FEV1 ) and the RDR , defined as FEV1 fall ( % ) at the final step divided by the corresponding provocative dosage .
-RESULTS	Twenty uncontrolled , 22 partly controlled , 20 controlled asthmatics , and 21 healthy subjects were enrolled .
-RESULTS	Log10RDR was positively correlated with log10PD20FEV1 in both BPTs ( all P < 0.05 ) .
-RESULTS	Poorer asthma control was associated with significantly lower PD20FEV1 and higher RDR ( both P < 0.05 ) .
-RESULTS	The differences in PD20FEV1 and RDR between partly controlled and controlled asthma were unremarkable ( both P > 0.05 ) .
-RESULTS	Compared with log10PD20FEV1 , the log10RDR yielded similar diagnostic values in both BPTs .
-RESULTS	A lower percentile of RDR ( 25th percentile ) was associated with higher baseline FEV1 ( P < 0.05 ) and an increased proportion of well-controlled asthmatic patients .
-RESULTS	The combination of RDR and PD20FEV1 led to an increased diagnostic value compared with either parameter alone .
-CONCLUSIONS	RDR is a surrogate of PD20FEV1 for BPTs in asthma .
-CONCLUSIONS	This finding was not modified by different asthma control levels or the types of bronchoprovocants .
-
-###25787197
-BACKGROUND	In a previous randomized trial , we found that percutaneous coronary intervention ( PCI ) was not inferior to coronary artery bypass grafting ( CABG ) for the treatment of unprotected left main coronary artery stenosis at 1 year .
-OBJECTIVE	This study sought to determine the 5-year outcomes of PCI compared with CABG for the treatment of unprotected left main coronary artery stenosis .
-METHODS	We randomly assigned 600 patients with unprotected left main coronary artery stenosis to undergo PCI with a sirolimus-eluting stent ( n = 300 ) or CABG ( n = 300 ) .
-METHODS	The primary endpoint was a major adverse cardiac or cerebrovascular event ( MACCE : a composite of death from any cause , myocardial infarction , stroke , or ischemia-driven target vessel revascularization ) and compared on an intention-to-treat basis .
-RESULTS	At 5 years , MACCE occurred in 52 patients in the PCI group and 42 patients in the CABG group ( cumulative event rates of 17.5 % and 14.3 % , respectively ; hazard ratio [ HR ] : 1.27 ; 95 % confidence interval [ CI ] : 0.84 to 1.90 ; p = 0.26 ) .
-RESULTS	The 2 groups did not differ significantly in terms of death from any cause , myocardial infarction , or stroke as well as their composite ( 8.4 % and 9.6 % ; HR , 0.89 ; 95 % CI , 0.52 to 1.52 ; p = 0.66 ) .
-RESULTS	Ischemia-driven target vessel revascularization occurred more frequently in the PCI group than in the CABG group ( 11.4 % and 5.5 % , respectively ; HR : 2.11 ; 95 % CI : 1.16 to 3.84 ; p = 0.012 ) .
-CONCLUSIONS	During 5 years of follow-up , our study did not show significant difference regarding the rate of MACCE between patients who underwent PCI with a sirolimus-eluting stent and those who underwent CABG .
-CONCLUSIONS	However , considering the limited power of our study , our results should be interpreted with caution .
-CONCLUSIONS	( Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [ PRECOMBAT ] ; NCT00422968 ) .
-
-###25404659
-OBJECTIVE	To evaluate 3 - and 6-month weight-loss outcomes achieved when physicians refer overweight/obese patients to an automated 3-month Internet-based behavioral weight-loss intervention .
-METHODS	A total of 154 patients age 18-70 years with a BMI between 25 and 45 kg/m ( 2 ) and access to a personal computer and the Internet were randomly assigned to 3 months of Internet behavioral intervention ( IBI ; n = 77 ) with 12 weekly videos teaching behavioral weight-loss skills , a platform for submitting self-monitored data , and automated feedback or an education-only Internet-delivered eating and activity control group ( IDEA ; n = 77 ) .
-METHODS	Outcome measures were weight loss after 3 months ( primary outcome ) and 6 months and changes in weight-control behaviors ( secondary outcomes ) .
-RESULTS	In intent-to-treat analyses with baseline weight carried forward for missing data , IBI produced significantly larger mean ( SD ) weight losses than IDEA at 3 months ( 5.5 kg [ 4.4 ] vs. 1.3 kg [ 2.1 ] ) and 6 months ( 5.4 kg [ 5.6 ] vs. 1.3 kg [ 4.1 ] ) ( P < 0.001 ) .
-RESULTS	Participants in IBI compared with IDEA were also more likely to achieve a clinically significant weight loss of 5 % of initial body weight at 3 months ( 53.3 vs. 9.1 % ) and 6 months ( 48.1 vs. 15.6 % ) ( P < 0.001 ) and reported more frequent use of weight control-related strategies .
-CONCLUSIONS	Physician referral to an Internet-based behavioral weight-loss intervention produced clinically significant weight loss for over half of the patients studied .
-CONCLUSIONS	Further research is needed to determine the effectiveness of implementing this intervention more broadly within diverse health care settings .
-
-###25090414
-BACKGROUND	We aimed to determine the effects of treatment with intravenous immunoglobulin on bacterial infections in patients with hypogammaglobulinemia ( HGG ) after lung transplantation .
-METHODS	We performed a randomized , double-blind , placebo-controlled two-period crossover trial of immune globulin intravenous ( IVIG ) , 10 % Purified ( Gamunex , Bayer , Elkhart , IN ) monthly in eleven adults who had undergone lung transplantation more than three months previously .
-METHODS	We randomized study participants to three doses of IVIG ( or 0.1 % albumin solution ( placebo ) ) given four weeks apart followed by a twelve week washout and then three doses of placebo ( or IVIG ) .
-METHODS	The primary outcome was the number of bacterial infections within each treatment period .
-RESULTS	IVIG had no effect on the number of bacterial infections during the treatment period ( 3 during IVIG and 1 during placebo ; odds ratio 3.5 , 95 % confidence interval 0.4 to 27.6 , p = 0.24 ) .
-RESULTS	There were no effects on other infections , use of antibiotics , or lung function .
-RESULTS	IVIG significantly increased trough IgG levels at all time points ( least square means , 765.3 mg/dl during IVIG and 486.3 mg/dl during placebo , p < 0.001 ) .
-RESULTS	Four serious adverse events ( resulting in hospitalization ) occurred during the treatment periods ( 3 during active treatment and 1 during the placebo period , p = 0.37 ) .
-RESULTS	Chills , flushing , and nausea occurred during one infusion of IVIG .
-CONCLUSIONS	Treatment with IVIG did not reduce the short-term risk of bacterial infection in patients with HGG after lung transplantation .
-CONCLUSIONS	The clinical efficacy of immunoglobulin supplementation in HGG related to lung transplantation over the long term or with recurrent infections is unknown .
-BACKGROUND	Clinicaltrials.gov NCT00115778 .
-
-###24573743
-BACKGROUND	Colorectal cancer ( CRC ) is the fourth leading cause of cancer-related deaths worldwide .
-BACKGROUND	The combination of oxaliplatin-based treatments ( oxaliplatin plus infusional 5-fluorouracil and leucovorin [ FOLFOX ] or oxaliplatin plus capecitabine [ CapeOX ] ) and bevacizumab is a standard chemotherapy regimen for metastatic CRC ( mCRC ) .
-BACKGROUND	However , several clinical studies that tested S-1 plus oxaliplatin ( SOX ) indicate that SOX is also a treatment option for mCRC .
-BACKGROUND	TSU-68 is an oral compound that inhibits vascular endothelial growth factor receptor and platelet-derived growth factor receptor .
-BACKGROUND	The recommended dose of TSU-68 + SOX was previously determined in a phase I study of mCRC patients .
-BACKGROUND	The goal of this trial was to evaluate the efficacy of TSU-68 in combination with SOX .
-METHODS	This open-label multicenter randomized phase II trial was performed in Korea .
-METHODS	Treatment-naive mCRC patients with a performance status of 0 or 1 were randomized in a 1:1 ratio to receive either TSU-68 + SOX or SOX alone .
-METHODS	The primary endpoint was progression-free survival ( PFS ) .
-RESULTS	A total of 105 patients ( TSU-68 + SOX , 52 patients ; SOX alone , 53 patients ) were randomized .
-RESULTS	The median PFS was 7.0 months in the TSU-68 + SOX group ( hazard ratio [ HR ] , 1.057 ) and 7.2 months in the SOX group ( p = 0.8401 ) .
-RESULTS	The most frequent grade 3 and 4 adverse events were thrombocytopenia ( 9.6 % [ TSU-68 + SOX ] vs. 26.4 % [ SOX ] ) , neutropenia ( 13.5 % [ TSU-68 + SOX ] vs. 15.1 % [ SOX ] ) , and anemia ( 3.8 % [ TSU-68 + SOX ] vs. 13.2 % [ SOX ] ) .
-RESULTS	We observed a difference between the 2 groups for all grades of anemia ( 15.4 % [ TSU-68 + SOX ] vs. 32.1 % [ SOX ] ) , diarrhea ( 30.8 % [ TSU-68 + SOX ] vs. 47.2 % [ SOX ] ) , vomiting ( 50.0 % [ TSU-68 + SOX ] vs. 26.4 % [ SOX ] ) , and chromaturia ( 23.1 % [ TSU-68 + SOX ] vs. 0.0 % [ SOX ] ) .
-RESULTS	Analysis using a Cox proportional hazard model showed that baseline interleukin 6 ( IL-6 ) levels were associated with a survival benefit of TSU-68 ( p = 0.012 ) .
-CONCLUSIONS	TSU-68 + SOX had a favorable safety profile .
-CONCLUSIONS	However , TSU-68 did not have a synergistic effect on the efficacy of SOX .
-CONCLUSIONS	The baseline serum IL-6 level could be a prognostic factor for TSU-68 efficacy .
-
-###24601887
-BACKGROUND	This prospective , observer-blinded , randomised , multicentre study aimed at determining the non-inferiority of 50 mg of plain 1 % 2-chloroprocaine vs. 10 mg of 0.5 % plain bupivacaine in terms of sensory block onset time at T10 after spinal injection .
-BACKGROUND	The study hypothesis was that the difference in onset times of sensory block to T10 between the two drugs is 4 min .
-METHODS	One hundred and thirty patients undergoing lower abdominal or lower limb procedures ( 40 min ) were randomised to receive one of two treatments : 50 mg of plain 1 % 2-chloroprocaine ( Group C , n = 66 ) or 10 mg of plain 0.5 % bupivacaine ( Group B , n = 64 ) .
-METHODS	Times to sensory and motor block onsets , maximum sensory block level , readiness for surgery , regression of sensory and motor blocks , first analgesic requirements , unassisted ambulation , home discharge , and side effects after 24 h and 7 days were registered blindly .
-RESULTS	Chloroprocaine was comparable with plain 0.5 % bupivacaine in terms of time to sensory block at T10 level .
-RESULTS	Group C showed faster onsets of motor block ( 5 vs. 6 min ) , maximum sensory block level ( 8.5 vs. 14 min ) , resolution of sensory ( 105 vs. 225 min ) and motor ( 100 vs. 210 min ) blocks , unassisted ambulation ( 142.5 vs. 290.5 min ) , first analgesic requirement ( 120 vs. 293.5 min ) , and home discharge ( 150 vs. 325 min ) ( all comparisons , P < 0.05 ) .
-RESULTS	No chloroprocaine patient developed transient neurological symptoms .
-CONCLUSIONS	Spinal anaesthesia with 50 mg of plain 1 % 2-chloroprocaine is similar to 10 mg of plain 0.5 % bupivacaine in terms of onset of sensory block at T10 but shows quicker recovery from anaesthesia than with 0.5 % bupivacaine .
-
-###25218610
-OBJECTIVE	To evaluate the long-term safety and efficacy of prolonged-release oxycodone/naloxone ( OXN PR ) and its impact on quality of life ( QoL ) , in patients with moderate-to-severe cancer pain .
-METHODS	This was an open-label extension ( OLE ) of a 4 week , randomized , double-blind ( DB ) study in which patients with moderate-to-severe cancer pain had been randomized to OXN PR or oxycodone PR ( OxyPR ) .
-METHODS	During the OLE phase , patients were treated with OXN PR capsules ( 20/60 mg/day ) for 24 weeks .
-METHODS	Outcome measures included safety , efficacy and QoL .
-RESULTS	One hundred and twenty-eight patients entered the OLE , average pain scores based on the modified Brief Pain Inventory-Short Form were low and stable over the 24-week period .
-RESULTS	The improvement in bowel function and constipation symptoms as measured by the Bowel Function Index and patient assessment of constipation in patients treated with OXN PR during the 4-week DB study was maintained .
-RESULTS	In patients treated with OxyPR during the DB phase , bowel function and constipation symptoms were improved during the OLE .
-RESULTS	In the DB and in the OLE , health status and QoL were similar for patients treated with OXN PR and OxyPR .
-RESULTS	There were no unexpected safety or tolerability issues .
-CONCLUSIONS	In patients with moderate-to-severe cancer pain , long-term use of OXN PR is well tolerated and effective , resulting in sustained analgesia , improved bowel function and improved symptoms of constipation .
-
-###25337988
-BACKGROUND	Research to assess the effect of interventions to improve the processes of shared decision making and self-management directed at health care professionals is limited .
-BACKGROUND	Using the protocol of Intervention Mapping , a Web-based intervention directed at health care professionals was developed to complement and optimize health services in patient-centered care .
-OBJECTIVE	The objective of the Web-based intervention was to increase health care professionals ' intention and encouraging behavior toward patient self-management , following cardiovascular risk management guidelines .
-METHODS	A randomized controlled trial was used to assess the effect of a theory-based intervention , using a pre-test and post-test design .
-METHODS	The intervention website consisted of a module to help improve professionals ' behavior , a module to increase patients ' intention and risk-reduction behavior toward cardiovascular risk , and a parallel module with a support system for the health care professionals .
-METHODS	Health care professionals ( n = 69 ) were recruited online and randomly allocated to the intervention group ( n = 26 ) or ( waiting list ) control group ( n = 43 ) , and invited their patients to participate .
-METHODS	The outcome was improved professional behavior toward health education , and was self-assessed through questionnaires based on the Theory of Planned Behavior .
-METHODS	Social-cognitive determinants , intention and behavior were measured pre-intervention and at 1-year follow-up .
-RESULTS	The module to improve professionals ' behavior was used by 45 % ( 19/42 ) of the health care professionals in the intervention group .
-RESULTS	The module to support the health professional in encouraging behavior toward patients was used by 48 % ( 20/42 ) .
-RESULTS	The module to improve patients ' risk-reduction behavior was provided to 44 % ( 24/54 ) of patients .
-RESULTS	In 1 of every 5 patients , the guideline for cardiovascular risk management was used .
-RESULTS	The Web-based intervention was poorly used .
-RESULTS	In the intervention group , no differences in social-cognitive determinants , intention and behavior were found for health care professionals , compared with the control group .
-RESULTS	We narrowed the intervention group and no significant differences were found in intention and behavior , except for barriers .
-RESULTS	Results showed a significant overall difference in barriers between the intervention and the control group ( F1 = 4.128 , P = .02 ) .
-CONCLUSIONS	The intervention was used by less than half of the participants and did not improve health care professionals ' and patients ' cardiovascular risk-reduction behavior .
-CONCLUSIONS	The website was not used intensively because of time and organizational constraints .
-CONCLUSIONS	Professionals in the intervention group experienced higher levels of barriers to encouraging patients , than professionals in the control group .
-CONCLUSIONS	No improvements were detected in the processes of shared decision making and patient self-management .
-CONCLUSIONS	Although participant education level was relatively high and the intervention was pre-tested , it is possible that the way the information was presented could be the reason for low participation and high dropout .
-CONCLUSIONS	Further research embedded in professionals ' regular consultations with patients is required with specific emphasis on the processes of dissemination and implementation of innovations in patient-centered care .
-BACKGROUND	Netherlands Trial Register Number ( NTR ) : NTR2584 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2584 ( Archived by WebCite at http://www.webcitation.org/6STirC66r ) .
-
-###24833327
-BACKGROUND	Although high-dose N-acetylcysteine ( NAC ) has been suggested to reduce COPD exacerbations , it is unclear which category of patients with COPD would benefit most from NAC treatment .
-BACKGROUND	The objective of this study was to compare the effect of high-dose NAC ( 600 mg bid ) between high-risk and low-risk Chinese patients with COPD .
-METHODS	Patients with spirometry-confirmed stable COPD were randomized to treatment with either NAC 600 mg bid or placebo in addition to their usual treatments .
-METHODS	Patients were followed up every 16 weeks for a total of 1 year .
-METHODS	Further analysis was performed according to each patient 's exacerbation risk at baseline as defined by the current GOLD ( Global Initiative for Chronic Obstructive Lung Disease ) strategy to analyze the effect of high-dose NAC in high-risk and low-risk patients .
-RESULTS	Of the 120 patients with COPD randomized ( men , 93.2 % ; mean age , 70.8 0.74 years ; prebronchodilator FEV , 53.9 2.0 % ; baseline characteristics comparable between treatment groups ) , 108 ( NAC , 52 ; placebo , 56 ) completed the 1-year study .
-RESULTS	For high-risk patients ( n = 89 ) , high-dose NAC compared with placebo significantly reduced exacerbation frequency ( 0.85 vs 1.59 [ P = .019 ] and 1.08 vs 2.22 [ P = .04 ] at 8 and 12 months , respectively ) , prolonged time to first exacerbation ( P = .02 ) , and increased the probability of being exacerbation free at 1 year ( 51.3 % vs 24.4 % , P = .013 ) .
-RESULTS	This beneficial effect of high-dose NAC vs placebo was not significant in low-risk patients .
-CONCLUSIONS	High-dose NAC ( 600 mg bid ) for 1 year reduces exacerbations and prolongs time to first exacerbation in high-risk but not in low-risk Chinese patients with COPD .
-BACKGROUND	ClinicalTrials.gov ; No. : NCT01136239 ; URL : www.clinicaltrials.gov .
-
-###25500097
-BACKGROUND	Evidence-based preventive services for early detection of cancer and other health conditions offer profound health benefits , yet Americans receive only half of indicated services .
-BACKGROUND	Policy initiatives promote the adoption of information technologies to engage patients in care .
-BACKGROUND	We developed a theory-driven interactive preventive health record ( IPHR ) to engage patients in health promotion .
-BACKGROUND	The model defines five levels of functionality : ( 1 ) collecting patient information , ( 2 ) integrating with electronic health records ( EHRs ) , ( 3 ) translating information into lay language , ( 4 ) providing individualized , guideline-based clinical recommendations , and ( 5 ) facilitating patient action .
-BACKGROUND	It is hypothesized that personal health records ( PHRs ) with these higher levels of functionality will inform and activate patients in ways that simpler PHRs can not .
-BACKGROUND	However , realizing this vision requires both technological advances and effective implementation based upon clinician and practice engagement .
-METHODS	We are starting a two-phase , mixed-method trial to evaluate whether the IPHR is scalable across a large number of practices and how its uptake differs for minority and disadvantaged patients .
-METHODS	In phase 1 , 40 practices from three practice-based research networks will be randomized to add IPHR functionality to their PHR versus continue to use their existing PHR .
-METHODS	Throughout the study , we will engage intervention practices to locally tailor IPHR content and learn how to integrate new functions into their practice workflow .
-METHODS	In phase 2 , the IPHR to all nonintervention practices to observe whether the IPHR can be implemented more broadly ( Scalability ) .
-METHODS	Phase 1 will feature an implementation assessment in intervention practices , based on the RE-AIM model , to measure Reach ( creation of IPHR accounts by patients ) , Adoption ( practice decision to use the IPHR ) , Implementation ( consistency , fidelity , barriers , and facilitators of use ) , and Maintenance ( sustained use ) .
-METHODS	The incremental effect of the IPHR on receipt of cancer screening tests and shared decision-making compared to traditional PHRs will assess Effectiveness .
-METHODS	In phase 2 , we will assess similar outcomes as phase 1 except for effectiveness .
-CONCLUSIONS	This study will yield information about the effectiveness of new health information technologies designed to actively engage patients in their care as well as information about how to effectively implement and disseminate PHRs by engaging clinicians .
-BACKGROUND	ClinicalTrials.gov : NCT02138448 .
-
-###24983709
-BACKGROUND	Detailed characterization of asthma phenotypes is essential for identification of responder populations to allow directed personalized medical intervention .
-OBJECTIVE	The aim of this study was to identify distinctive patient characteristics within subgroups of a well-characterized severe asthma population at risk for exacerbations and to determine the treatment response within each subgroup .
-METHODS	A supervised cluster analysis with recursive partitioning approach was applied to data from the Dose Ranging Efficacy And safety with Mepolizumab ( DREAM ) study to identify characteristics that maximized the differences across subgroups .
-METHODS	Exacerbation rate ratios were calculated for each cluster comparing mepolizumab versus placebo .
-RESULTS	Three predictors were identified in four primary clusters : blood eosinophils , airway reversibility , and body mass index .
-RESULTS	The reduction in exacerbations was significantly greater in patients who received mepolizumab ( clusters 2 , 3 , and 4 ) with raised eosinophils ( responder population ) .
-RESULTS	Cluster 2 with low airway reversibility ( mean , 11 % ) had a 53 % reduction in exacerbations .
-RESULTS	These patients more frequently reported sinusitis and nasal polyposis .
-RESULTS	Those with higher airway reversibility ( mean , 28 % ) were further split by body mass index .
-RESULTS	The nonobese versus obese ( clusters 3 and 4 ) had a 35 and 67 % reduction in exacerbations , respectively .
-RESULTS	Cluster 4 also had patients with more comorbidities , including hypertension , weight gain , and anxiety .
-CONCLUSIONS	Using supervised cluster analysis helped identify specific patient characteristics related to disease and therapeutic response .
-CONCLUSIONS	Patients with eosinophilic inflammation received significant therapeutic benefit with mepolizumab , and responses differed within clusters .
-CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT01000506 ) .
-
-###25804039
-OBJECTIVE	To study a trend in active sacroiliitis ( ASI ) in patients with axial spondyloarthritis ( axSpA ) during different short-term regimens using etoricoxib ( ET ) 90 mg .
-METHODS	Forty patients with axSpA , including 30 with ankylosing spondyloarthritis ) , and ASI ( sacroiliac joint ( SIJ ) osteitis as evidenced by magnetic resonance imaging ) were examined and then randomized to 2 groups : 1 ) 20 patients who took ET 90 mg four days or more a week ; 2 ) 20 patients who received ET 90 mg 3 days or less a week .
-METHODS	Osteitis was measured in 4 quadrants of each SIJ ( 0-3 scores ) .
-METHODS	Its main criterion was considered to be a decrease in total osteitis activity ( TOA ) 12 week later .
-RESULTS	In all the patients ( n = 40 ) , TOA decreased from 6.5 ( 4 ; 9 ) to 2 ( 0 ; 5 ) scores ( p < 0.0001 ) .
-RESULTS	In Group 1 ( n = 20 ) , that reduced from 6.5 ( 4 ; 8.5 ) to 0 ( 0 ; 3 ) scores ( p < 0.0001 ) .
-RESULTS	In Group 2 ( n = 20 ) , that did from 6.5 ( 4 ; 10 ) to 4 ( 1 ; 8 ) scores ( p = 0.49 ) .
-RESULTS	At 12 weeks , in in Groups 1 and 2 , the difference in final TOA achieved no statistical significance ( p = 0.056 ) .
-RESULTS	In these groups , there were 19 ( 95 % ) and 14 ( 70 % ) treatment-responsive patients , respectively .
-CONCLUSIONS	The intake of ET 90 mg for 12-weeks is associated with a reduction in the degree of ASI in patients with axSpA .
-CONCLUSIONS	The use of ET 4 times or more a week is more effective in diminishing osteitis than that of ET 3 days or less .
-
-###24498235
-OBJECTIVE	To examine herpes simplex virus 2 ( HSV-2 ) / HIV co-infection as a contributing factor in the increase in HIV infection among non-injecting heroin and cocaine users in New York City .
-METHODS	Subjects were recruited from the Beth Israel Medical Center drug detoxification and methadone maintenance programs in New York City in 1995-1999 and 2005-2011 .
-METHODS	All reported current heroin and/or cocaine use and no injection drug use .
-METHODS	A structured questionnaire was administered and serum samples collected for HIV and HSV-2 testing .
-METHODS	Population-attributable risk percentages ( PAR % s ) were estimated for associations between HSV-2 and increased susceptibility to and increased transmissibility of HIV among female NIDUs .
-RESULTS	785 subjects were recruited from 1995-1999 , and 1764 subjects from 2005-2011 .
-RESULTS	HIV prevalence increased from 7 % to 13 % , with nearly uniform increases among all demographic subgroups .
-RESULTS	HSV-2 / HIV co-infection was common in both time periods , with an average ( over the two time periods ) of 80 % of HIV negative females infected with HSV-2 , an average of 43 % of HIV negative males infected with HSV-2 ; an average of 97 % of HIV positive females also infected with HSV-2 and an average of 67 % of HIV positive males also infected with HSV-2 .
-RESULTS	The increase in HIV prevalence was predominantly an increase in HSV-2 / HIV co-infection , with relatively little HIV mono-infection in either time period .
-RESULTS	The estimated PAR % s indicate that approximately half of HIV acquisition among females was caused by HSV-2 infection and approximately 60 % of HIV transmission from females was due to HSV-2 co-infection .
-CONCLUSIONS	The increase in HIV infection among these non-injecting drug users is better considered as an increase in HSV-2 / HIV co-infection rather than simply an increase in HIV prevalence .
-CONCLUSIONS	Additional interventions ( such as treatment as prevention and suppressing the effects of HSV-2 on HIV transmission ) are needed to reduce further HIV transmission from HSV-2 / HIV co-infected non-injecting drug users .
-
-###25406780
-BACKGROUND	Incontinence-associated dermatitis ( IAD ) is a potentially serious skin injury that can lead to pressure ulcers ( PUs ) .
-BACKGROUND	Multiple studies have indicated the need for evidence to find the most effective skin care protocol to reduce the incidence and severity of IAD in critically ill patients .
-OBJECTIVE	To compare the incidence and severity of IAD in two groups on a progressive care unit ( PCU ) using a defined skin care protocol : cleaning with a gentle cleanser and moisturizer , then applying a skin protectant/barrier .
-OBJECTIVE	The control group received the skin care protocol every 12 hours and the interventional group received the protocol every 6 hours ; both groups also received it as needed .
-METHODS	A 9-month randomized prospective study was conducted on 99 patients ( N = 55 in the intervention group and N = 44 in the control group ) who were incontinent of urine , stool , or both , or had a fecal diversion device or urinary catheter for more than 2 days .
-RESULTS	The dermatitis score in the intervention group on discharge was significantly less ( 7.1 % ; P 0.001 ) in the moderate IAD group than in the control group ( 10.9 % ) .
-RESULTS	The dermatitis score means and P values of each group were compared using a paired t test .
-CONCLUSIONS	The researchers studied a defined skin care protocol using a cleanser with aloe vera and a cleansing lotion , followed by application of either a moisture barrier with silicone or skin protectant with zinc oxide and menthol , undertaken at two different frequencies .
-CONCLUSIONS	Data revealed the incidence of moderate IAD was decreased in the experimental group ( receiving the skin protocol every 6 hours and p.r.n. ) .
-
-###25518180
-BACKGROUND	Disclosing agents have a long history of use as an aid in children 's tooth brushing instruction .
-BACKGROUND	However , their benefit when used to improve self-performed tooth brushing ability without any tooth brushing instruction has not been investigated .
-OBJECTIVE	To evaluate the effect of disclosed plaque visualization on improving the self-performed , tooth brushing ability of primary school children .
-METHODS	A cluster-randomized , crossover study was conducted in Nakhon Nayok province , Thailand .
-METHODS	A total of 122 second-grade schoolchildren , aged 8-10 years old , from 12 schools were randomly divided into 2 groups .
-METHODS	The first group was assigned to brush with disclosed plaque visualization , while the other group brushed without disclosed plaque visualization .
-METHODS	One month later the groups switched procedures .
-METHODS	Tooth brushing ability was evaluated by the subjects ' reduction in patient hygiene performance ( PHP ) scores .
-METHODS	The data were analyzed using repeated-measures analysis of variance , with significance set at p < 0.05 .
-RESULTS	Disclosed plaque visualization had a significant effect on improving the children 's self-performed , tooth brushing ability in all areas of the mouth ( p < 0.001 ) , particularly for anterior teeth , mandibular teeth , buccal surfaces , and areas adjacent to the gingival margin ( p < 0.001 ) .
-CONCLUSIONS	Disclosed plaque visualization is a viable technique to improve children 's self-performed tooth brushing ability , and could be used in school-based oral health promotion programs .
-
-###25236397
-BACKGROUND	The purpose of this study was to assess the effect of Roux-en-Y gastric bypass ( RYGB ) with different pouch size in Chinese type 2 diabetes mellitus ( T2DM ) patients with measured body mass index ( BMI ) 30-35 kg/m ( 2 ) .
-METHODS	In this randomized and prospective study , we evaluated the efficacy of RYGB with smaller size pouch ( 10-20 ml ) versus larger pouch size ( 25-35 ml ) in 76 Chinese obese patients ( 33 F , 43 M ) with T2DM .
-METHODS	According to protocol , all patients were divided into two groups , smaller pouch size group and larger pouch size group , and underwent RYGB surgery .
-METHODS	Primary inclusion criteria of study were ( a ) a diagnosis of type 2 diabetes ( glycated hemoglobin level > 7.0 % ) , ( b ) measured BMI of at least 30 kg/m ( 2 ) and not yet 35 kg/m ( 2 ) , and ( c ) age between 25 and 60 years old , and ( d ) patients were excluded if they had previously undergone complex abdominal surgery or bariatric surgery .
-METHODS	Weight loss , BMI , percentage of excess weight loss ( % EWL ) , glycated hemoglobin , and fasting plasma glucose were obtained at 3 , 6 , 9 , and 12 months after surgery .
-RESULTS	Of these 76 patients , 69 ( 91 % ) patients completed follow-up postoperative 12 months .
-RESULTS	Weight loss and % EWL at 12 months was greater in smaller pouch size group ( mean 15.8 kg , 95 % CI -17.2 to -14.4 and mean 68.9 , 95 % CI 62.5-75 .2 % ) than in larger pouch size group ( mean -13.7 kg , 95 % CI -15.3 to -12.1 , and mean 59.1 , 95 % CI 52.8-65 .5 ) ( P = 0.046 , P = 0.033 , respectively ) .
-RESULTS	Glycemic control improved in both two groups , with a mean glycated hemoglobin level of 6.2 % ( 95 % CI 6.0-6 .5 % ) in smaller size group , and 6.7 % ( 95 % CI 6.4-7 .0 % ) in larger size group ( P = 0.025 , P < 0.05 ) .
-RESULTS	The fasting plasma glucose level decreased significantly after surgery , with a mean level of 5.4 mmol/L ( 95 % CI 5.2-5 .5 mmol/L ) and 5.6 mmol/L ( 95 % CI 5.5-5 .8 mmol/L ) respectively , ( P = 0.040 , P < 0.05 ) .
-CONCLUSIONS	In this short-term study , in Chinese T2DM patients with BMI 30-35 kg/m ( 2 ) , we observed a greater efficiency on weight loss and glycemic control with smaller pouch size compared to larger pouch size .
-CONCLUSIONS	In the future , long-term follow-up and large sample study will be necessary to confirm these outcomes .
-
-###25554995
-BACKGROUND	Depression commonly co-occurs with alcohol use disorders but predictors of depression treatment outcome in patients with both conditions are not well established .
-METHODS	Outpatients with alcohol dependence and major depression ( n = 138 ) were prescribed naltrexone and randomized to citalopram or placebo for 12 weeks , followed by a 12-week naturalistic outcome phase .
-METHODS	General linear mixed models examined predictors of Montgomery Asberg Depression Rating Scale ( MADRS ) score over 24 weeks .
-METHODS	Predictors included whether depression was independent or substance-induced , and demographic , alcohol use , and personality variables ( Temperament and Character Inventory subscales ) .
-RESULTS	Most improvement in drinking and depression occurred between baseline and week 3 .
-RESULTS	During follow-up , patients with substance-induced depression reduced their drinking more and they had better depression outcomes than those with independent depression .
-RESULTS	However , greater reduction in drinking was associated with better depression outcomes for both independent and substance-induced groups , while antidepressant therapy had no effect for either group .
-RESULTS	Baseline demographic and alcohol use variables did not predict depression outcomes .
-RESULTS	Among personality variables , high self-directedness was a strong predictor of better depression outcomes .
-CONCLUSIONS	Subjects were not abstinent at baseline .
-CONCLUSIONS	The influence of naltrexone on depression outcomes could not be tested .
-CONCLUSIONS	Alcohol dependent patients with substance-induced depression have better short term depression outcomes than those with independent depression , but this is largely because they reduce their drinking more during treatment .
-
-###24220044
-OBJECTIVE	To evaluate the effects of training in methods of preventing childhood obesity on self-efficacy ( SE ) in nurses .
-METHODS	In a randomized , controlled trial conducted in child health services in Sweden , nurses in the intervention and control groups of the PRIMROSE prevention trial of childhood obesity were offered a 5-day workshop on dietary and physical activity interventions , and motivational interviewing .
-METHODS	Self-efficacy for influencing parents to promote healthy dietary and physical activity behaviors in their children was measured using an 18-item instrument .
-METHODS	Difference in SE between groups at post-assessment was analyzed using multiple linear regression analysis .
-RESULTS	Compared to control nurses ( n = 38 ) , intervention nurses ( n = 22 ) demonstrated higher SE ( = 14.70 , P < .001 ) .
-CONCLUSIONS	Training in methods of preventing childhood obesity increased SE in nurses .
-CONCLUSIONS	Self-efficacy should be included as a construct in evaluations of clinical training .
-
-###25466402
-OBJECTIVE	To determine the prevalence and predictors of sexual dysfunction ( SD ) in Parkinson 's disease ( PD ) patients .
-BACKGROUND	Assessments of SD in the professional literature is limited .
-BACKGROUND	Understanding the predictors of SD can help physicians focus on this problem in vulnerable patients .
-METHODS	A total of 60 PD patients and 60 controls answered the Arizona Sexual Experiences Scale-Thai Version ( ASEX-Thai ) and the Hamilton Depression Rating Scale ( HAMD ) questionnaires , and were asked on 3 additional sets of questions about premature ejaculation ( PE ) , dyspareunia , and hypersexual disorders .
-RESULTS	The prevalence of SD in PD patients and controls was 81.6 % and 48.3 % respectively ( p < 0.05 ) .
-RESULTS	PD patients had lower BMI , lower uric acid level , higher HAMD score and had sexual intercourse ( SI ) less frequently .
-RESULTS	SD correlated with greater disease severity and depression .
-RESULTS	The most distressing problem in male patients was PE ( 51.4 % ) and orgasmic dissatisfaction ( 76 % ) for female patients .
-RESULTS	Logistic regression analysis found 3 factors were related to SD : no SI in the past month ( p < 0.001 ) , postural instability ( PI ) ( p = 0.028 ) , and HAMD item 14 ( p = 0.021 ) , predicting SD with the OR of 12.2 , 5.5 , and 5.0 respectively .
-CONCLUSIONS	SD in PD is common and usually occurs with depression .
-CONCLUSIONS	Absence of SI in the past month , PI , and loss of libido are predictors of SD in PD .
-CONCLUSIONS	A simple and quick screening of SD can be routinely performed by inquiring patients about the frequency of SI and the examination of the pull test .
-CONCLUSIONS	Detailed assessment of sexual functioning and depression may guide physicians in proper management .
-
-###24875810
-BACKGROUND	The aim of this study was to evaluate the efficacy of buttressed stapling using a stapler with an attached polyglycolic acid sheet in reducing the rate of air leak associated with pulmonary lobectomy .
-BACKGROUND	Materials and
-METHODS	A prospective , randomized , phase III study was conducted to confirm the superiority of a buttressed stapler in a test treatment group to a conventional nonbuttressed stapler in a current international standard of care group among patients undergoing pulmonary lobectomy .
-METHODS	The primary end point was the frequency of intraoperative air leaks .
-RESULTS	Although no fatal postoperative bleeding occurred in the present study , this trial closed early with 100 patients because the manufacturer recalled the buttressed stapler based on reports of 13 serious injuries and 3 fatalities following pulmonary resection in routine clinical practice .
-RESULTS	A total of 76 patients treated with a stapler ( 35 in the non-B group and 41 in the B group ) were included as subjects in the analysis .
-RESULTS	No statistical differences were observed between the groups in the frequency of intraoperative air leaks ( 22 [ 63 % ] vs. 26 [ 63 % ] ) or the postoperative duration of air leaks ( mean : 3.5 vs. 2.9 days ) .
-RESULTS	The frequency of air leak from stapler holes was significantly lower in the B group than in the non-B group ( 2 % [ 1/41 ] vs. 20 % [ 7/35 ] ; p = 0.016 ) .
-CONCLUSIONS	The efficacy of buttressed stapling in reducing the rate of air leak in patients undergoing pulmonary lobectomy could not be clearly demonstrated .
-CONCLUSIONS	However , air leak from stapler holes can be prevented with buttressed stapling .
-
-###24931587
-OBJECTIVE	To assess the effect of acetazolamide ( Az ) on exercise performance during early acclimatization to altitude .
-METHODS	Az ( 250 mg twice daily ) or placebo was administered for 3 days in a double-blind , randomized manner followed by a rapid ascent to 3459 m in the Italian Alps .
-METHODS	Twenty healthy adults ( age range , 18-67 years ) were tested at 60 % of sea-level peak power output for 15 minutes on a bicycle ergometer after 16 to 27 hours of altitude exposure .
-METHODS	Exercise performance was measured in relation to peripheral oxygen saturations measured from pulse oximetry ( Spo2 ) , Lake Louise acute mountain sickness ( AMS ) score , and perceived difficulty .
-RESULTS	At altitude , resting Spo2 was higher in the Az group compared with placebo ( P < .001 ) .
-RESULTS	The highest AMS scores were in 4 of the placebo individuals with the lowest resting Spo2 ( P < .05 ) .
-RESULTS	During the exercise test , Spo2 fell in all but 1 subject ( P < .001 ) and was reduced more in the Az group ( P < .01 ) .
-RESULTS	Four Az and 1 placebo subject were unable to complete the exercise test ; 4 of these 5 had the largest fall in Spo2 .
-RESULTS	The perception of exercise difficulty was higher in the Az subjects compared with those taking the placebo ( P < .01 ) .
-RESULTS	There was an age relationship with exercise limitation ; 4 of the 9 older than 50 years failed to complete the test whereas only 1 of 11 younger than 50 years failed , and there were no failures in the 6 younger than 30 years ( P < .05 ) .
-CONCLUSIONS	In this study group , and despite higher resting Spo2 , Az may have compromised exercise at 3459 m altitude during early acclimatization , particularly in older subjects .
-
-###24411004
-BACKGROUND	X-ray mammography remains the predominant test for screening for breast cancer , with the aim of reducing breast cancer mortality .
-BACKGROUND	In the English NHS Breast Screening Programme each woman 's mammograms are examined separately by two expert readers .
-BACKGROUND	The two readers read each batch in the same order and each indicates if there should be recall for further tests .
-BACKGROUND	This is a highly skilled , pressurised , repetitive and frequently intellectually unchallenging activity where readers examine one or more batches of 30-50 women 's mammograms in each session .
-BACKGROUND	A vigilance decrement or performance decrease over time has been observed in similar repetitive visual tasks such as radar operation .
-METHODS	The CO-OPS study is a pragmatic , multi-centre , two-arm , double blind cluster randomised controlled trial of a computer software intervention designed to reduce the effects of a vigilance decrement in breast cancer screening .
-METHODS	The unit of randomisation is the batch .
-METHODS	Intervention batches will be examined in the opposite order by the two readers ( one forwards , one backwards ) .
-METHODS	Control batches will be read in the same order as one another , as is current standard practice .
-METHODS	The hypothesis is that cancer detection rates will be higher in the intervention group because each readers ' peak performance will occur when examining different women 's mammograms .
-METHODS	The trial will take place in 44 English breast screening centres for 1 year and 4 months .
-METHODS	The primary outcome is cancer detection rate , which will be extracted from computer records after 1 year of the trial .
-METHODS	The secondary outcomes include rate of disagreement between readers ( a more statistically powerful surrogate for cancer detection rate ) , recall rate , positive predictive value , and interval cancer rate ( cancers found between screening rounds which will be measured three years after the end of the trial ) .
-CONCLUSIONS	This is the first trial of an intervention to ameliorate a vigilance decrement in breast cancer screening .
-BACKGROUND	ISRCTN46603370 ( submitted : 24 October 2012 , date of registration : 26 March 2013 ) .
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-###24450471
-BACKGROUND	According to the American Diabetes Association ( ADA ) , the nutritional goals for patients with type 2 diabetes ( T2D ) are to achieve an optimal nutrient intake to achieve normoglycemia and a cardioprotective lipid profile .
-BACKGROUND	Peanuts are nutrient dense foods that contain high levels of monounsaturated fat ( MUFA ) and are a natural source of arginine , fiber , phytosterols , resveritrol , niacin , folate , vitamin E and magnesium , which have the potential for improving blood lipids and glycemic control .
-BACKGROUND	This study sought to evaluate the effect of a peanut enriched ADA meal plan on the nutrient profile of the total diet and cardiometabolic parameters in adults with T2D .
-METHODS	This was a randomized , prospective 24-week parallel-group clinical trial with 60 adults with T2D [ age range 34-84years ; body mass index ( BMI ) range 17.2-48 .7 kg/m2 ] .
-METHODS	Subjects consumed an ADA meal plan containing ~ 20 % of energy from peanuts ( peanut group ) or a peanut-free ADA meal plan ( control group ) .
-METHODS	Weight , BMI , waist circumference ( WC ) and nutrient intake from 24-hour recalls were measured every 4 weeks and fasting blood glucose ( FBG ) , HbA1c and blood lipids were measured every 12 weeks .
-METHODS	A mixed-model repeated-measures analysis of covariance was performed to assess the significance of changes in the cardiometabolic parameters .
-RESULTS	A higher polyunsaturated fat ( PUFA ) to saturated fat diet ratio and higher intake of MUFA , PUFA , - tocopherol , niacin and magnesium was observed in the peanut group as compared to the control group ( P < 0.01-P = 0.04 ) .
-RESULTS	Both groups experienced mild reductions in weight , BMI , and WC during the study ( P = 0.01-P = 0.03 ) , however there were no differences between the two groups in these measurements or in FBG , HbA1c or blood lipids .
-RESULTS	For each kilogram of weight loss in the entire cohort there were associations for reductions in WC of 0.48 cm ( P < 0.01 ) , FBG of 0.11 mmol/l ( P = 0.01 ) and HbA1c of 0.07 % ( P < 0.01 ) .
-CONCLUSIONS	Daily consumption of a peanut enriched ( 46g/d ) ADA meal plan over 24 weeks improves the nutrient profile of the total diet and is compatible with weight management and improvement in specific blood lipids .
-BACKGROUND	ClinicalTrials.gov NCT00937222 .
-
-###24381187
-BACKGROUND	We tested the association between pulmonary dead-space fraction ( ratio of dead space to tidal volume [ V ( D ) / V ( T ) ] ) and mortality in subjects with ARDS ( Berlin definition , P ( aO2 ) / F ( IO2 ) 300 mm Hg ; PEEP 5 cm H2O ) enrolled into a clinical trial incorporating lung-protective ventilation .
-METHODS	We conducted a prospective , multi-center study at medical-surgical ICUs in the United States .
-METHODS	A total of 126 ALI subjects with acute lung injury were enrolled into a phase 3 randomized , placebo-controlled study of aerosolized albuterol .
-METHODS	V ( D ) / V ( T ) and pulmonary mechanics were measured within 4 h of enrollment and repeated daily on study days 1 and 2 in subjects requiring arterial blood gases for clinical management .
-RESULTS	At baseline , non-survivors had a trend toward higher V ( D ) / V ( T ) compared with survivors ( 0.62 0.11 vs 0.56 0.11 , respectively , P = .08 ) .
-RESULTS	Differences in V ( D ) / V ( T ) between non-survivors and survivors became significant on study days 1 ( 0.64 0.12 vs 0.55 0.11 , respectively , P = .01 ) and 2 ( 0.67 0.12 vs 0.56 0.11 , respectively , P = .004 ) .
-RESULTS	Likewise , the association between VD/VT and mortality was significant on study day 1 ( odds ratio per 0.10 change in V ( D ) / V ( T ) [ 95 % CI ] : 6.84 [ 1.62-28 .84 ] P = .01 ; and study day 2 : 4.90 [ 1.28-18 .73 ] P = .02 ) after adjusting for V ( D ) / V ( T ) , P ( aO2 ) / F ( IO2 ) , oxygenation index , vasopressor use , and the primary risk for ARDS .
-RESULTS	Using a Cox proportional hazard model , V ( D ) / V ( T ) was associated with a trend toward higher mortality ( HR = 4.37 [ CI 0.99-19 .32 ] , P = .052 ) that became significant when the analysis was adjusted for daily oxygenation index ( HR = 1.74 [ 95 % CI 1.12-3 .35 ] P = .04 ) .
-CONCLUSIONS	Markedly elevated V ( D ) / V ( T ) ( 0.60 ) in early ARDS is associated with higher mortality .
-CONCLUSIONS	Measuring V ( D ) / V ( T ) may be useful in identifying ARDS patients at increased risk of death who are enrolled into a therapeutic trial .
-
-###25391865
-OBJECTIVE	To evaluate image quality of low-voltage coronary artery computed tomographic ( CT ) angiography with low contrast agent in comparison with image quality .
-METHODS	Forty-five patients underwent coronary artery computed tomographic ( CT ) angiography .
-METHODS	They were randomly assigned to 3 groups , group A ( n = 15 ) were scanned in 120 kVp with 350 mgI/ml iodinated contrast agent mode , group B ( n = 15 ) were scanned in 100 kVp with 350 mgI/ml iodinated contrast agent mode , group C ( n = 15 ) were scanned in 100 kVp with 270 mgI/ml iodinated contrast agent mode .
-METHODS	Then measured CT attenuation value of three main branches ( RCA , LAD and CX ) of coronary artery , And compare the SNR , CNR , the effective radiation dose ( ED ) and iodine intake .
-METHODS	The Kappa test were used to quantify inter - and intra-reader agreement in detecting quality of the images under different scanning solutions .
-RESULTS	Three groups of coronary artery CT image quality was no statistically significant differences ( all P values > 0.05 ) , Good inter - and intra-reader agreement ( k = 0.754 , P < 0.05 ) for the detection of noise in all the patients .
-RESULTS	There was significant difference in the CT attenuation of RCA , LAD and CX among the 3 groups ( P < 0.05 ) , the CT attenuation was the highest in group B , the CT value of RCA , LAD and CX were 537 90 , 505 90 , 484 75 HU , respectively.the CT attenuation was the lowest in group C , the CT value of RCA , LAD and CX were 357 126 , 360 95 , 378 121 HU , respectively .
-RESULTS	There was no significant difference in the SNR and CNR among the 3 groups ( P > 0.05 ) .
-RESULTS	There was significant difference in the ED among the 3 groups ( P < 0.05 ) .
-RESULTS	The ED value of the group A was bigger than the value of the group B and C.
-RESULTS	There was no significant difference between the group B and C. Compared the group A and B , the iodine intake of the group C had fallen by 23 % .
-CONCLUSIONS	The coronary artery CT angiography using 100 kVp with 270 mgI/ml iodinated contrast agent provide similar objective or subjective image quality compared with the ( 350 mgI/ml ) and the 100 kVp ( 350 mgI/ml ) , thus enabling effective dose and iodine intake reduction without loss of diagnostic information .
-
-###24439462
-OBJECTIVE	To determine precisely the mean change in refractive power induced by treatment in patients with diabetic macular edema ( DME ) .
-METHODS	Prospective , randomized study .
-METHODS	Fifty eyes of 50 consecutive patients with clinically significant macular edema receiving all 3 types of current state-of-the-art treatment with intravitreal antiedematous substances ( ranibizumab , bevacizumab , or triamcinolone ) .
-METHODS	Patients were followed up at monthly intervals and were treated following a standardized pro re nata regimen according to protocol .
-METHODS	Best-corrected visual acuity ( BCVA ) was determined by certified visual acuity examiners .
-METHODS	The refractive power of the treated eyes was determined using a push-plus technique .
-METHODS	The change in refraction between baseline and the visit when the macula was completely dry or when the central subfield thickness ( CST ) measured by optical coherence tomography had reached the thinnest level was analyzed .
-METHODS	Spherical equivalent refraction ( SER ) and CST .
-RESULTS	Fifty eyes of 50 patients received intravitreal therapy using ranibizumab ( n = 11 ) , bevacizumab ( n = 20 ) , or triamcinolone ( n = 19 ) .
-RESULTS	Mean BCVA was 0.330.23 logarithm of the minimum angle of resolution ( logMAR ) and mean CST was 492130 m.
-RESULTS	The mean SER was 0.412.06 diopters ( D ) at baseline .
-RESULTS	The BCVA at the time of optimal retinal morphologic features was 0.240.2 logMAR , mean CST was 30078 m , and mean change in SER was -0.010.46 D. Changes is BCVA and CST were statistically significant ( P < 0.0001 ) , but the SER change was not ( P = 0.824 ) .
-CONCLUSIONS	Appropriate spectacle correction can be prescribed to patients with DME any time during ongoing therapy using antiedematous substances because resolution of retinal thickening is not associated with an increased risk of a myopic shift .
-
-###24814973
-OBJECTIVE	High-frequency oscillation combined with tracheal gas insufflation ( HFO-TGI ) improves oxygenation in patients with acute respiratory distress syndrome ( ARDS ) .
-OBJECTIVE	There are limited physiologic data regarding the effects of HFO-TGI on hemodynamics and pulmonary edema during ARDS .
-OBJECTIVE	The aim of this study was to investigate the effect of HFO-TGI on extravascular lung water ( EVLW ) .
-METHODS	We conducted a prospective , randomized , crossover study .
-METHODS	Consecutive eligible patients with ARDS received sessions of conventional mechanical ventilation with recruitment maneuvers ( RMs ) , followed by HFO-TGI with RMs , or vice versa .
-METHODS	Each ventilatory technique was administered for 8 hours .
-METHODS	The order of administration was randomly assigned .
-METHODS	Arterial/central venous blood gas analysis and measurement of hemodynamic parameters and EVLW were performed at baseline and after each 8-hour period using the single-indicator thermodilution technique .
-RESULTS	Twelve patients received 32 sessions .
-RESULTS	Pao2/fraction of inspired oxygen and respiratory system compliance were higher ( P < .001 for both ) , whereas extravascular lung water index to predicted body weight and oxygenation index were lower ( P = .021 and .029 , respectively ) in HFO-TGI compared with conventional mechanical ventilation .
-RESULTS	There was a significant correlation between Pao2/fraction of inspired oxygen improvement and extravascular lung water index drop during HFO-TGI ( Rs = -0.452 , P = .009 ) .
-CONCLUSIONS	High-frequency oscillation combined with tracheal gas insufflation improves gas exchange and lung mechanics in ARDS and potentially attenuates EVLW accumulation .
-
-###25597563
-OBJECTIVE	To examine the association between blood pressure ( BP ) measures and symptoms of apathy and depression in older adults with various levels of functional ability .
-METHODS	Cross-sectional study using baseline data from the Discontinuation of Antihypertensive Treatment in Elderly people ( DANTE ) Study Leiden .
-METHODS	Primary care setting , the Netherlands .
-METHODS	Community-dwelling individuals aged 75 and older ( N = 430 ) .
-METHODS	Systolic BP ( SBP ) , diastolic BP ( DBP ) , and mean arterial pressure ( MAP ) were measured during home visits .
-METHODS	Symptoms of apathy and depression were assessed using the Apathy Scale and the Geriatric Depression Scale ( GDS-15 ) , respectively .
-METHODS	Stratified linear regression was performed in participants with better and worse functional ability according to the median of the Groningen Activity Restriction Scale .
-RESULTS	In participants with lower functional ability , each 10-mmHg lower SBP , DBP , and MAP was associated with higher Apathy Scale scores ( 0.63 , 0.92 , and 0.94 points , respectively , all P < .005 ) but not with GDS-15 scores .
-RESULTS	In participants with higher functional ability , BP measures were not associated with Apathy Scale or GDS-15 scores .
-CONCLUSIONS	In older participants with poorer functional ability , lower BP was associated with more symptoms of apathy but not depression .
-
-###24463662
-OBJECTIVE	To examine the association between second-trimester maternal serum 25-hydroxyvitamin D concentrations and risk of small for gestational age ( SGA ) in singleton live births .
-METHODS	We assayed serum samples at 12-26 weeks of gestation for 25-hydroxyvitamin D in a sample of participants in a multicenter clinical trial of low-dose aspirin for the prevention of preeclampsia in high-risk women ( n = 792 ) .
-METHODS	Multivariable log-binomial regression models were used to assess the association between 25-hydroxyvitamin D and risk of SGA ( birth weight less than the 10 percentile for gestational age ) after adjustment for confounders including maternal prepregnancy obesity , race , treatment allocation , and risk group .
-RESULTS	Thirteen percent of neonates were SGA at birth .
-RESULTS	Mean ( standard deviation ) 25-hydroxyvitamin D concentrations were lower in women who delivered SGA ( 57.9 [ 29.9 ] nmol/L ) compared with non-SGA neonates ( 64.8 [ 29.3 ] nmol/L , P = .028 ) .
-RESULTS	In adjusted models , 25-hydroxyvitamin D concentrations of 50-74 nmol/L and 75 nmol/L or greater compared with less than 30 nmol/L were associated with 43 % ( 95 % confidence interval [ CI ] 0.33-0 .99 ) and 54 % ( 95 % CI 0.24-0 .87 ) reductions in risk of SGA , respectively .
-RESULTS	Race and maternal obesity each modified this association .
-RESULTS	White women with 25-hydroxyvitamin D 50 nmol/L or greater compared with less than 50 nmol/L had a 68 % reduction in SGA risk ( adjusted risk ratio 0.32 , 95 % CI 0.17-0 .63 ) and nonobese women with 25-hydroxyvitamin D 50 nmol/L or greater compared with less than 50 nmol/L had a 50 % reduction in SGA risk ( adjusted risk ratio 0.50 , 95 % CI 0.31-0 .82 ) .
-RESULTS	There was no association between 25-hydroxyvitamin D and risk of SGA in black or obese mothers .
-CONCLUSIONS	Maternal vitamin D status in the second trimester is associated with risk of SGA among all women and in the subgroups of white and nonobese women .
-METHODS	II .
-
-###24831970
-BACKGROUND	Bright constant light levels in the NICU may have negative effects on the growth and development of preterm infants
-OBJECTIVE	The aim of this study is to evaluate the benefits of an alternating light/dark cycle in the NICU on weight gain and early discharge from the therapy in premature infants .
-METHODS	A randomized interventional study was designed comparing infants in the NICU of Hospital Juarez de Mxico , exposed from birth either to an LD environment ( LD , n = 19 ) or to the traditional continuous light ( LL , n = 19 ) .
-METHODS	The LD condition was achieved by placing individual removable helmets over the infant 's heads .
-METHODS	Body weight gain was analyzed , as the main indicator of stability and the main criteria for discharge in preterm infants born at 31.730.31 week gestational age .
-RESULTS	Infants maintained in an LD cycle gained weight faster than infants in LL and therefore attained a shorter hospital stay , ( 34.373.12 vs 51.115.29 days ; P > 0.01 ) .
-RESULTS	Also , LD infants exhibited improved oxygen saturation and developed a daily melatonin rhythm .
-CONCLUSIONS	These findings provide a convenient alternative for establishing an LD environment for preterm healthy newborns in the NICU and confirm the beneficial effects of an alternating LD cycle for growth and weight gain and for earlier discharge time .
-CONCLUSIONS	Here we provide an easy and practical alternative to implement light/dark conditions in the NICU .
-
-###25475358
-OBJECTIVE	Over-the-counter combinations containing acetaminophen and phenylephrine for treatment of the common cold and influenza are widespread , but there are few data about pharmacokinetics of these two drugs used in combination .
-OBJECTIVE	We aimed to investigate pharmacokinetic interactions between acetaminophen and phenylephrine .
-METHODS	A series of four randomised , open-label , crossover studies investigating phenylephrine and acetaminophen combination pharmacokinetics were undertaken ( n = 28 , 30 , 6 and 26 ) using standard non-compartmental analyses .
-METHODS	Time-concentration observations from these four studies were pooled to examine the interaction between these two compounds .
-METHODS	Data were analysed using non-linear mixed effects models .
-RESULTS	Non-compartmental analyses showed an approximate doubling of phenylephrine plasma concentration when the standard 10-mg dose was administered in combination with acetaminophen .
-RESULTS	Population analysis was based on data from 90 subjects with 2050 observations .
-RESULTS	The relative bioavailability of phenylephrine 10 mg was doubled ( Fbio 2.11 , 95 % CI 1.89 , 2.31 ) when combined with acetaminophen 1000 mg , while the absorption half-time was reduced by 50 % .
-RESULTS	When combined with 500 mg of acetaminophen , bioavailability increased by 64 % ( Fbio 1.64 ) .
-RESULTS	Phenylephrine 5 mg in combination with acetaminophen 1000 mg produced a phenylephrine plasma time-concentration profile similar to that seen with phenylephrine 10 mg administered alone .
-CONCLUSIONS	The relative bioavailability of phenylephrine was increased when co-administered with acetaminophen .
-
-###24361097
-BACKGROUND	The Schirmer test ( ST ) evaluates the volume of tears in potential dry eye candidates via a strip placed in the lower tear lake .
-BACKGROUND	Previously reported inconsistencies in the results may be in part due to the lack of standardization as to the methodology , e.g. the eye position during the test .
-BACKGROUND	The purpose of this study was to evaluate the effect of eye position on the ST score .
-METHODS	A ST was performed in a randomized fashion with and without anesthesia in three open eye positions ( primary , superior and inferior ) at 20 from each other .
-METHODS	Palpebral aperture , age and a dry eye questionnaire ( OSDI ) were evaluated for correlation with the ST.
-RESULTS	In the 20 non-dry eye volunteers ( n = 20 , ages 18-40 , mean OSDI score 10.5 ) , the ST results were , as expected , lower overall ( p < .001 ) with anesthesia ( 11.33 7.78 mm ) than without ( 19.74 2.83 mm ) .
-RESULTS	The inferior gaze position resulted in higher values ( p < .03 ) than the other two positions , regardless of the use of anesthesia .
-RESULTS	No correlation was noted between the palpebral aperture , age , questionnaire and the ST.
-CONCLUSIONS	The ST seems to be influenced by the position of gaze .
-CONCLUSIONS	However , the mechanism for this , effect remains unclear .
-CONCLUSIONS	Further studies could focus on whether an inferior gaze of 20 compresses the tear film falsely , thereby elevating the tear volume .
-CONCLUSIONS	It is recommended that the clinician should adopt a standard eye position for the ST and that future reports provide specifics as to the methodology used .
-
-###25873721
-BACKGROUND	To prospectively evaluate whether short-term high-intensity ( interval ) training ( HI ( I ) T ) induces detectable morphological cardiac changes in previously untrained men in cardiovascular magnetic resonance imaging .
-RESULTS	Eighty-four untrained volunteers were randomly assigned to a HI ( I ) T group ( n = 42 ; 44.14.7 years ) or an inactive control group ( n = 42 ; 42.35.6 years ) .
-RESULTS	HI ( I ) T focused on interval runs ( intensity : 95 % -105 % of individually calculated heart rate at the anaerobic threshold ) .
-RESULTS	Before and after 16 weeks , all subjects underwent physiological examination , stepwise treadmill test with blood lactate analysis , and contrast-enhanced cardiovascular magnetic resonance imaging ( cine , tagging , and delayed enhancement ) .
-RESULTS	Indexed left ventricular ( LV ) and right ventricular ( RV ) volume ( LV , 77.18.5-83 .98.6 ; RV , 80.58.5-86 .68.1 ) and mass ( LV , 58.26.4-63 .48.1 ; RV , 14.81.7-16 .12.1 ) significantly increased with HI ( I ) T. Changes in LV and RV morphological parameters with HI ( I ) T were highly correlated with an increase in maximal aerobic capacity ( VO2max ) and a decrease in blood lactate concentration at the anaerobic threshold .
-RESULTS	Mean LV and RV remodeling index of HI ( I ) T group did not alter with training ( 0.76 0.09 and 0.240.10 g/mL , respectively [ P = 0.97 and P = 0.72 ] ) , indicating balanced cardiac adaptation .
-RESULTS	Myocardial circumferential strain decreased after HI ( I ) T within all 6 basal segments ( anteroseptal , P = 0.01 and anterolateral , P < 0.001 ) .
-RESULTS	There was no late gadolinium enhancement in any of the participants before or post HI ( I ) T.
-CONCLUSIONS	Sixteen weeks of HI ( I ) T lead to measurable changes in cardiac atrial and ventricular morphology and function in previously untrained men .
-CONCLUSIONS	This correlates with improvements in parameters of endurance capacity .
-BACKGROUND	URL : http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT01406730 .
-
-###25002832
-BACKGROUND	Shoulder surgery is often performed in the beach-chair position , a position associated with arterial hypotension and subsequent risk of cerebral ischaemia .
-BACKGROUND	It can be performed under general anaesthesia or with an interscalene brachial plexus block , each of which has specific advantages but also specific negative effects on blood pressure control .
-BACKGROUND	It would be worthwhile to combine the advantages of the two , but the effects of the combination on the circulation are not well investigated .
-BACKGROUND	We studied blood pressure , heart rate , and incidence of adverse circulatory events in patients undergoing shoulder surgery in general anaesthesia with or without an interscalene block .
-METHODS	Prospective , randomised , blinded study in outpatients ( age 18 to 80years ) undergoing shoulder arthroscopy .
-METHODS	General anaesthesia was with propofol/opioid , interscalene block with 40ml 1 % mepivacaine .
-METHODS	Hypotension requiring treatment was defined as a mean arterial pressure < 60mmHg or a systolic pressure < 80 % of baseline ; relevant bradycardia was a heart rate < 50bpm with a decrease in blood pressure .
-RESULTS	Forty-two patients had general anaesthesia alone , 41 had general anaesthesia plus interscalene block .
-RESULTS	The average systolic blood pressure under anaesthesia in the beach-chair position was 1147.3 vs. 1168.3 mmHg ( p = 0.09 ; all comparisons General vs. General-Regional ) .
-RESULTS	The incidence of a mean arterial pressure under 60mmHg or a decrease in systolic pressure of more than 20 % from baseline was 64 % vs. 76 % ( p = 0.45 ) .
-RESULTS	The number of patients with a heart rate lower than 50 and a concomitant blood pressure decrease was 8 vs. 5 ( p = 0.30 ) .
-CONCLUSIONS	One can safely combine interscalene block with general anaesthesia for surgery in the beach-chair position in ASA I and II patients .
-BACKGROUND	DRKS00005295 .
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-###25175124
-OBJECTIVE	No clinically effective treatment for promoting peripheral axonal regeneration has yet been established .
-OBJECTIVE	Several experimental studies in vitro and in vivo have shown that a high dose of methylcobalamin ( MeCbl ) , an analogue of vitamin B12 , promotes axonal growth in peripheral nerve injury .
-OBJECTIVE	We herein assessed the safety and efficacy of an ultra-high dose MeCbl treatment for patients with peripheral neuropathy and chronic axonal degeneration .
-METHODS	Fourteen patients with immune-mediated or hereditary neuropathy in the chronic progressive or stable phase were enrolled .
-METHODS	MeCbl , 25 mg/day for 10 days followed by monthly 25 mg for 5 months , was intravenously administered .
-METHODS	The patients were evaluated before and 1 year following treatment .
-METHODS	The primary endpoints were safety and improvement in the Medical Research Council ( MRC ) sum score in at least two muscles of the 20 muscles .
-METHODS	This trial is registered with the University Hospital Medical Information Network ( UMIN ) Center in Japan under the ID : UMIN000009359 .
-RESULTS	There were no adverse effects in twelve of the patients , whereas treatment was discontinued in two patients who had seborrheic dermatitis at 3 months and respiratory tract infection at 2 months , respectively .
-RESULTS	Therefore , twelve patients were evaluated for the primary outcomes ; the MRC sum score was improved in seven of the patients and unchanged or worsened in the remaining five patients .
-CONCLUSIONS	Intravenous ultra-high dose MeCbl treatment is a safe and potentially efficacious therapy for patients with peripheral neuropathy and chronic axonal degeneration .
-
-###24612471
-OBJECTIVE	To validate robot-assisted surgery skills acquisition using an augmented reality ( AR ) - based module for urethrovesical anastomosis ( UVA ) .
-METHODS	Participants at three institutions were randomised to a Hands-on Surgical Training ( HoST ) technology group or a control group .
-METHODS	The HoST group was given procedure-based training for UVA within the haptic-enabled AR-based HoST environment .
-METHODS	The control group did not receive any training .
-METHODS	After completing the task , the control group was offered to cross over to the HoST group ( cross-over group ) .
-METHODS	A questionnaire administered after HoST determined the feasibility and acceptability of the technology .
-METHODS	Performance of UVA using an inanimate model on the daVinci Surgical System ( Intuitive Surgical Inc. , Sunnyvale , CA , USA ) was assessed using a UVA evaluation score and a Global Evaluative Assessment of Robotic Skills ( GEARS ) score .
-METHODS	Participants completed the National Aeronautics and Space Administration Task Load Index ( NASA TLX ) questionnaire for cognitive assessment , as outcome measures .
-METHODS	A Wilcoxon rank-sum test was used to compare outcomes among the groups ( HoST group vs control group and control group vs cross-over group ) .
-RESULTS	A total of 52 individuals participated in the study .
-RESULTS	UVA evaluation scores showed significant differences in needle driving ( 3.0 vs 2.3 ; P = 0.042 ) , needle positioning ( 3.0 vs 2.4 ; P = 0.033 ) and suture placement ( 3.4 vs 2.6 ; P = 0.014 ) in the HoST vs the control group .
-RESULTS	The HoST group obtained significantly higher scores ( 14.4 vs 11.9 ; P 0.012 ) on the GEARS .
-RESULTS	The NASA TLX indicated lower temporal demand and effort in the HoST group ( 5.9 vs 9.3 ; P = 0.001 and 5.8 vs 11.9 ; P = 0.035 , respectively ) .
-RESULTS	In all , 70 % of participants found that HoST was similar to the real surgical procedure , and 75 % believed that HoST could improve confidence for carrying out the real intervention .
-CONCLUSIONS	Training in UVA in an AR environment improves technical skill acquisition with minimal cognitive demand .
-
-###24350814
-OBJECTIVE	The purpose of this study was to test the efficacy of clomipramine and fluoxetine , controlled by placebo , and compare their action in children and adolescents with anxiety disorders .
-METHODS	Thirty subjects ( ages 7-17 years ) , who were diagnosed with generalized anxiety disorder and/or separation anxiety disorder and/or social phobia , were submitted to a 12 week double-blind , randomized , placebo-controlled trial of clomipramine and fluoxetine .
-METHODS	The instruments included : the Schedule for Affective Disorders and Schizophrenia , the Multidimensional Anxiety Scale for Children , the Children 's Depression Inventory , the Clinical Global Impressions , and the Children 's Global Assessment Scale .
-RESULTS	All groups ( clomipramine [ n = 9 ] , fluoxetine [ n = 10 ] , placebo [ n = 11 ] ) showed a significant improvement after 12 weeks of treatment .
-RESULTS	There were significant differences between the fluoxetine and placebo groups in some ratings of anxiety severity and impairment .
-RESULTS	No significant differences were observed between clomipramine and placebo groups or between fluoxetine and clomipramine groups .
-CONCLUSIONS	Treatment with placebo showed an unusual high response rate .
-CONCLUSIONS	Clomipramine showed similar efficacy compared with fluoxetine , although it was not superior to placebo .
-
-###24763910
-BACKGROUND	Opioid antagonism reduces the consumption of palatable foods in humans but the neural substrates implicated in these effects are less well understood .
-OBJECTIVE	The aim of the present study was to examine the effects of the opioid antagonist , naltrexone , on neural response to rewarding and aversive sight and taste stimuli .
-METHODS	We used functional magnetic resonance imaging ( fMRI ) to examine the neural responses to the sight and taste of pleasant ( chocolate ) and aversive ( mouldy strawberry ) stimuli in 20 healthy volunteers who received a single oral dose of naltrexone ( 50mg ) and placebo in a double-blind , repeated-measures cross-over , design .
-RESULTS	Relative to placebo , naltrexone decreased reward activation to chocolate in the dorsal anterior cingulate cortex and caudate , and increased aversive-related activation to unpleasant strawberry in the amygdala and anterior insula .
-CONCLUSIONS	These findings suggest that modulation of key brain areas involved in reward processing , cognitive control and habit formation such as the dorsal anterior cingulate cortex ( dACC ) and caudate might underlie reduction in food intake with opioid antagonism .
-CONCLUSIONS	Furthermore we show for the first time that naltrexone can increase activations related to aversive food stimuli .
-CONCLUSIONS	These results support further investigation of opioid treatments in obesity .
-
-###25183726
-BACKGROUND	Disturbance of the sleep-wake cycle is a characteristic of delirium .
-BACKGROUND	In addition , changes in melatonin rhythm influence the circadian rhythm and are associated with delirium .
-BACKGROUND	We compared the effect of melatonin and placebo on the incidence and duration of delirium .
-METHODS	We performed this multicentre , double-blind , randomized controlled trial between November 2008 and May 2012 in 1 academic and 2 nonacademic hospitals .
-METHODS	Patients aged 65 years or older who were scheduled for acute hip surgery were eligible for inclusion .
-METHODS	Patients received melatonin 3 mg or placebo in the evening for 5 consecutive days , starting within 24 hours after admission .
-METHODS	The primary outcome was incidence of delirium within 8 days of admission .
-METHODS	We also monitored the duration of delirium .
-RESULTS	A total of 452 patients were randomly assigned to the 2 study groups .
-RESULTS	We subsequently excluded 74 patients for whom the primary end point could not be measured or who had delirium before the second day of the study .
-RESULTS	After these postrandomization exclusions , data for 378 patients were included in the main analysis .
-RESULTS	The overall mean age was 84 years , 238 ( 63.0 % ) of the patients lived at home before admission , and 210 ( 55.6 % ) had cognitive impairment .
-RESULTS	We observed no effect of melatonin on the incidence of delirium : 55/186 ( 29.6 % ) in the melatonin group v. 49/192 ( 25.5 % ) in the placebo group ; difference 4.1 ( 95 % confidence interval -0.05 to 13.1 ) percentage points .
-RESULTS	There were no between-group differences in mortality or in cognitive or functional outcomes at 3-month follow-up .
-CONCLUSIONS	In this older population with hip fracture , treatment with melatonin did not reduce the incidence of delirium .
-BACKGROUND	Netherlands Trial Registry , NTR1576 : MAPLE ( Melatonin Against PLacebo in Elderly patients ) study ; www.trialregister.nl/trialreg/admin/rctview.asp?TC=1576 .
-
-###25348510
-BACKGROUND	Left ventricular hypertrophy is associated with adverse outcomes , including death , during cardiac surgery .
-BACKGROUND	This may be facilitated by an increased oxygen demand and diastolic dysfunction .
-BACKGROUND	Levosimendan augments haemodynamics without further oxygen consumption and improves echocardiographic indices of diastolic dysfunction .
-BACKGROUND	This study aimed to describe the haemodynamic effects of short-term pre - and intra-operative levosimendan infusion including advanced echocardiographic measures of diastolic and systolic heart function .
-METHODS	The study was randomised , double-blinded and placebo-controlled performed at a single-centre university hospital .
-METHODS	Patients with left ventricular hypertrophy and ejection fraction > 45 % scheduled for single procedure aortic valve replacement were included and randomised to infusion of either levosimendan 0.1 g/kg/min or placebo from 4 h before anaesthesia to the end of surgery .
-METHODS	Outcome measures were echocardiographic indices of left ventricular diastolic function : E/e ' ( primary endpoint ) , e ' , e ' / a ' and indices of systolic function : longitudinal strain , ejection fraction and s ' .
-METHODS	Patients were followed until 6 months after surgery .
-METHODS	In addition , invasive haemodynamic measures were obtained perioperatively .
-RESULTS	The trial was prematurely terminated due to an overall high incidence of post-operative atrial fibrillation ( 15/20 , P = 0.002 ) after inclusion of 20 patients .
-RESULTS	The relative decrease in perioperative cardiac index was lower ( P = 0.016 ) in the levosimendan group .
-RESULTS	There was no difference in E/e ' , and similar results were found for all measures of systolic function .
-CONCLUSIONS	Short-term levosimendan caused a transient relative increase in cardiac index , but no effect was seen on the first post-operative day and up to 6 months post-operatively with indices of systolic and diastolic heart function .
-
-###24746177
-OBJECTIVE	Chemotherapy-induced nausea and vomiting ( CINV ) is an unanswered problem in cancer therapy .
-OBJECTIVE	We evaluated the efficacy and safety of triple antiemetic therapy with aprepitant , a 5-hydroxytryptamine-3 ( 5-HT ( 3 ) ) receptor antagonist , and dexamethasone in patients with advanced non-small-cell lung cancer ( NSCLC ) who received carboplatin-based first-line chemotherapy .
-METHODS	Chemotherapy-nave patients with NSCLC were enrolled in this randomized phase-II study .
-METHODS	Patients were randomized to standard antiemetic therapy with a 5-HT ( 3 ) receptor antagonist and dexamethasone , and aprepitant add-on triple antiemetic therapy .
-METHODS	The primary endpoint was the complete response rate ( no vomiting and no rescue therapy ) during the 120 h post-chemotherapy .
-RESULTS	A total of 134 patients were assigned randomly to the aprepitant group or the control group .
-RESULTS	The aprepitant group and the control group showed an overall complete response rate of 80.3 % ( 95 % confidence interval ( CI ) , 69.2-88 .1 % ) and 67.2 % ( 95 % CI , 55.3-77 .2 % ; odds ratio ( OR ) , 0.50 ; 95 % CI , 0.22-1 .10 ; p = 0.085 ) , respectively .
-RESULTS	Among patients taking carboplatin and pemetrexed , adding aprepitant significantly improved the complete response rate in the overall phase ( 83.8 % in the aprepitant group and 56.8 % in the control group ; OR , 0.26 ; 95 % CI , 0.08-0 .70 ; p < 0.01 ) and the delayed phase ( 86.5 % in the aprepitant group and 59.1 % in the control group ; OR , 0.23 ; 95 % CI , 0.07-0 .65 ; p < 0.01 ) .
-CONCLUSIONS	Carboplatin-based chemotherapy has considerable emetic potential .
-CONCLUSIONS	Triple antiemetic therapy with aprepitant , a 5-HT ( 3 ) receptor antagonist , and dexamethasone improved the control of CINV prevention in patients receiving carboplatin and pemetrexed chemotherapy .
-
-###24854966
-BACKGROUND	Shebeens in South Africa are settings in which alcohol use and sexual behavior often co-occur .
-BACKGROUND	The prevalence of alcohol use disorder ( AUD ) , and the association between AUD , situations and settings , and sexual risk behavior , in shebeens remains unknown .
-METHODS	Men ( n = 763 ; mean age = 30 ; 98 % Black African ) were recruited from townships in Cape Town , South Africa and completed a self-administered survey that assessed alcohol use , sexual risk behaviors , and situations and settings of alcohol use .
-METHODS	The Alcohol Use Disorder and Associated Disabilities Interview Schedule DSV-IV Version ( AUDADIS-IV ) was used to identify the likelihood of AUD .
-METHODS	Bivariate regression analyses assessed whether screening for AUD predicted sexual risk behaviors .
-METHODS	Multivariate regression analyses examined whether AUD and/or situations/settings predicted risk behaviors .
-RESULTS	Nearly two-thirds of men ( 62 % ) endorsed sufficient criteria for AUD ; 25 % , 17 % , and 20 % were classified as having a mild , moderate , or severe AUD , respectively .
-RESULTS	AUD was associated with HIV risk such that men with AUD reported more unprotected sex than men without AUD .
-RESULTS	Analyses indicated that ( a ) individual ( i.e. , AUD ) and ( b ) settings ( i.e. , frequency of having sex with a partner in a shebeen , tavern , or bottle store ) interacted to predict unprotected sex .
-CONCLUSIONS	The prevalence of AUD among shebeen patrons was high and was associated with unprotected sex .
-CONCLUSIONS	Findings suggest the need to integrate both individual and situational/setting factors to prevent HIV among patrons of shebeens .
-
-###25573021
-BACKGROUND	Several endoscopic dilation techniques have been reported for treatment of anastomotic-stenosis of esophageal cancer , but the high incidence of dysphagia has remained unchanged .
-BACKGROUND	The aim of this study was to compare the effect of Argon Plasma Coagulation ( APC ) combined with Savary Bougienage ( SB ) compared to APC alone or SB alone for anastomotic-stenosis after radical operation for squamous cell carcinoma of the esophagus .
-METHODS	Patients with anastomotic-stenosis that was diagnosed for the first time following esophageal squamous cell carcinoma resection surgery were randomly assigned to undergo APC combined with SB , APC alone , or SB alone .
-METHODS	Primary endpoints were the dysphagia-free survival ( DFS defined as the time from first dilatation of effectively relieved dysphagia to dysphagia relapse expressed in days ) after 6 months of follow up .
-RESULTS	A total of 90 patients from the Cancer Institute , First Affiliated Hospital of Henan University of Science and Technology were entered into the study ( APC group , n = 30 , SB group , n = 30 , combination group [ APC combined with SB ] , n = 30 ) .
-RESULTS	Primary endpoints : 6 months after treatment , DFS of combination group ( 115.63 days ; 95 % CI , 105.31-125 .95 ) was significantly longer than the APC alone group ( 39.53 days ; 95 % CI , 35.95-43 .11 , p = 0.000 ) and the SB alone group ( 16.93 days ; 95 % CI , 15.01-18 .84 , p = 0.000 ) .
-RESULTS	No severe complications occurred within the three treatment groups .
-CONCLUSIONS	APC combined with SB was a safe and well-tolerated method for relieving dysphagia of esophageal squamous cell cancer patients with anastomotic-stenosis .
-CONCLUSIONS	( Registered with randomized controlled trials , ChiCRT , registration number ChiCTR-TRC-13003757 . )
-
-###24556040
-BACKGROUND	An unmet medical need exists for patients with metastatic renal cell carcinoma who have progressed on VEGF-targeted and mTOR-inhibitor therapies .
-BACKGROUND	Fibroblast growth factor ( FGF ) pathway activation has been proposed as a mechanism of escape from VEGF-targeted therapies .
-BACKGROUND	Dovitinib is an oral tyrosine-kinase inhibitor that inhibits VEGF and FGF receptors .
-BACKGROUND	We therefore compared dovitinib with sorafenib as third-line targeted therapies in patients with metastatic renal cell carcinoma .
-METHODS	In this multicentre phase 3 study , patients with clear cell metastatic renal cell carcinoma who received one previous VEGF-targeted therapy and one previous mTOR inhibitor were randomly assigned through an interactive voice and web response system to receive open-label dovitinib ( 500 mg orally according to a 5-days-on and 2-days-off schedule ) or sorafenib ( 400 mg orally twice daily ) in a 1:1 ratio .
-METHODS	Randomisation was stratified by risk group and region .
-METHODS	The primary endpoint was progression-free survival ( PFS ) assessed by masked central review .
-METHODS	Efficacy was assessed in all patients who were randomly assigned and safety was assessed in patients who received at least one dose of study drug .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT01223027 .
-RESULTS	284 patients were randomly assigned to the dovitinib group and 286 to the sorafenib group .
-RESULTS	Median follow-up was 113 months ( IQR 79-146 ) .
-RESULTS	Median PFS was 37 months ( 95 % CI 35-39 ) in the dovitinib group and 36 months ( 35-37 ) in the sorafenib group ( hazard ratio 086 , 95 % CI 072-104 ; one-sided p = 0063 ) .
-RESULTS	280 patients in the dovitinib group and 284 in the sorafenib group received at least one dose of study drug .
-RESULTS	Common grade 3 or 4 adverse events included hypertriglyceridaemia ( 38 [ 14 % ] ) , fatigue ( 28 [ 10 % ] ) , hypertension ( 22 [ 8 % ] ) , and diarrhoea ( 20 [ 7 % ] ) in the dovitinib group , and hypertension ( 47 [ 17 % ] ) , fatigue ( 24 [ 8 % ] ) , dyspnoea ( 21 [ 7 % ] ) , and palmar-plantar erythrodysaesthesia ( 18 [ 6 % ] ) in the sorafenib group .
-RESULTS	The most common serious adverse event was dyspnoea ( 16 [ 6 % ] and 15 [ 5 % ] in the dovitinib and sorafenib groups , respectively ) .
-CONCLUSIONS	Dovitinib showed activity , but this was no better than that of sorafenib in patients with renal cell carcinoma who had progressed on previous VEGF-targeted therapies and mTOR inhibitors .
-CONCLUSIONS	This trial provides reference outcome data for future studies of targeted inhibitors in the third-line setting .
-BACKGROUND	Novartis Pharmaceuticals Corporation .
-
-###24490977
-BACKGROUND	Recruitment is one of the most serious challenges in performing randomized controlled trials .
-BACKGROUND	Often clinical trials with participants diagnosed with schizophrenia are terminated prematurely because of recruitment challenges resulting in a considerable waste of resources in the form of time , funding , and the participants ' efforts .
-BACKGROUND	Dropout rates in schizophrenia trials are also high.Recruitment challenges are often due to patients not wanting to participate in research but can also be due to clinicians ' concerns regarding individuals diagnosed with schizophrenia as participants in research .
-BACKGROUND	This paper reports how overcoming recruitment challenges not related to patients revealed high readiness to take part and low dropout rates in a one year long randomized controlled trial testing Guided Self-Determination ( GSD ) among outpatients with schizophrenia receiving treatment in Assertive Outreach Teams in the northern part of Denmark .
-METHODS	GSD is a shared decision-making and mutual problem-solving method using reflection sheets , which was developed in diabetes care and adjusted for this study and utilized by patients with schizophrenia .
-METHODS	Descriptive data on strategies to overcome recruitment challenges were derived from notes and observations made during the randomized controlled trial testing of GSD in six outpatient teams .
-RESULTS	Three types of recruitment challenges not related to patients were identified and met during the trial : 1 ) organizational challenges , 2 ) challenges with finding eligible participants and 3 ) challenges with having professionals invite patients to participate .
-RESULTS	These challenges were overcome through : 1 ) extension of time , 2 ) expansion of the clinical recruitment area and 3 ) encouragement of professionals to invite patients to the study .
-RESULTS	Through overcoming these challenges , we identified a remarkably high patient-readiness to take part ( 101 of 120 asked accepted ) and a low dropout rate ( 8 % ) .
-CONCLUSIONS	Distinction between recruitment challenges was important in discovering the readiness among patients with schizophrenia to take part in and complete a trial with the GSD-intervention .
-
-###24882370
-OBJECTIVE	The main aim was to assess the effects of a spa treatment on the resumption of occupational and non-occupational activities and the abilities of women in breast cancer remission .
-OBJECTIVE	A cost-effectiveness analysis ( CEA ) was also performed .
-METHODS	A multicentre randomised controlled trial was carried out between 2008 and 2010 in the University Hospital of Auvergne and two private hospitals in Clermont-Ferrand , France .
-METHODS	Eligible patients were women in complete breast cancer remission without contraindication for physical activities or cognitive disorders and a body mass index between 18.5 and 40 kg/m ( 2 ) .
-METHODS	The intervention group underwent spa treatment combined with consultation with dietician whereas the control underwent consultations with the dietician only .
-METHODS	Of the 181 patients randomised , 92 and 89 were included in the intervention and the control groups , respectively .
-METHODS	The CEA involved 90 patients , 42 from the intervention group and 48 from the control group .
-RESULTS	The main results showed a higher rate of resumption of occupational activities in the intervention group ( p = 0.0025 ) and a positive effect of the intervention on the women 's ability to perform occupational activities 12 months after the beginning of the study ( p = 0.0014 ) , and on their ability to perform family activities ( p = 0.033 ) .
-RESULTS	The stay in a thermal centre was cost-effective at 12 months .
-CONCLUSIONS	Spa treatment is a cost-effective strategy to improve resumption of occupational and non-occupational activities and the abilities of women in breast cancer remission .
-
-###25179753
-OBJECTIVE	Medical treatment settings such as emergency departments ( EDs ) present important opportunities to address problematic substance use .
-OBJECTIVE	Currently , EDs do not typically intervene beyond acute medical stabilization .
-OBJECTIVE	To contrast the effects of a brief intervention with telephone boosters ( BI-B ) with those of screening , assessment , and referral to treatment ( SAR ) and minimal screening only ( MSO ) among drug-using ED patients .
-METHODS	Between October 2010 and February 2012 , 1285 adult ED patients from 6 US academic hospitals , who scored 3 or greater on the 10-item Drug Abuse Screening Test ( indicating moderate to severe problems related to drug use ) and who were currently using drugs , were randomized to MSO ( n = 431 ) , SAR ( n = 427 ) , or BI-B ( n = 427 ) .
-METHODS	Follow-up assessments were conducted at 3 , 6 , and 12 months by blinded interviewers .
-METHODS	Following screening , MSO participants received only an informational pamphlet .
-METHODS	The SAR participants received assessment plus referral to addiction treatment if indicated , and the BI-B participants received assessment and referral as in SAR , plus a manual-guided counseling session based on motivational interviewing principles and up to 2 `` booster '' sessions by telephone during the month following the ED visit .
-METHODS	Outcomes evaluated at follow-up visits included self-reported days using the patient-defined primary problem drug , days using any drug , days of heavy drinking , and drug use based on analysis of hair samples .
-METHODS	The primary outcome was self-reported days of use of the patient-defined primary problem drug during the 30-day period preceding the 3-month follow-up .
-RESULTS	Follow-up rates were 89 % , 86 % , and 81 % at 3 , 6 , and 12 months , respectively .
-RESULTS	For the primary outcome , estimated differences in number of days of use ( 95 % CI ) were as follows : MSO vs BI-B , 0.72 ( -0.80 to 2.24 ) , P ( adjusted ) = .57 ; SAR vs BI-B , 0.70 ( -0.83 to 2.23 ) , P ( adjusted ) = .57 ; SAR vs MSO , -0.02 ( -1.53 to 1.50 ) , P ( adjusted ) = .98 .
-RESULTS	There were no significant differences between groups in self-reported days using the primary drug , days using any drug , or heavy drinking days at 3 , 6 , or 12 months .
-RESULTS	At the 3-month follow-up , participants in the SAR group had a higher rate of hair samples positive for their primary drug of abuse ( 265 of 280 [ 95 % ] ) than did participants in the MSO group ( 253 of 287 [ 88 % ] ) or the BI-B group ( 244 of 275 [ 89 % ] ) .
-RESULTS	Hair analysis differences between groups at other time points were not significant .
-CONCLUSIONS	In this sample of drug users seeking emergency medical treatment , a relatively robust brief intervention did not improve substance use outcomes .
-CONCLUSIONS	More work is needed to determine how drug use disorders may be addressed effectively in the ED .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01207791 .
-
-###24556530
-BACKGROUND	The `` m '' in mHealth is often thought of as the ability to receive health information and monitor behaviors on the go .
-BACKGROUND	Little is known about how people actually use mobile vs. traditional access methods and if access method affects engagement and health outcomes .
-METHODS	This study examines the 3-month outcomes of two mobile weight loss interventions ( Pounds Off Digitally ( POD ) and mobile POD ( mPOD ) ) where participants were required to own a mobile device for study entry and received weight loss information via podcast .
-METHODS	Only participants in both studies who were randomized to receive the same theory-based podcast ( TBP ) were used in this analysis .
-METHODS	In POD , 41 participants were randomized to the TBP condition ( 37 to a control not included in this analyses ) .
-METHODS	In mPOD , 49 participants were randomized to the TBP ( n = 49 ) and 47 to the TBP + mobile group ( a self-monitoring app and Twitter app for social support ) .
-METHODS	The goal of this study is to examine how participants accessed study components and to examine how type of device impacts engagement and weight loss .
-RESULTS	Examining data from both studies in aggregate , despite a mobile delivery method , 58 % of participants reported using a non-mobile device to access the majority of the podcasts ( desktop computers ) , 76 % accessed the podcasts mostly at their home or work , and 62 % were mainly non-mobile ( e.g. , sitting at work ) when listening .
-RESULTS	Examining objective download data for mPOD , 49 % of downloads ( 2889/5944 ) originated from non-mobile delivery methods vs. mobile platforms ( 3055/5944 ) .
-RESULTS	At 3 months , 55 % of Twitter posts originated from the website ( n = 665 posts ) vs. a mobile app ( n = 540 ; 45 % ) .
-RESULTS	There was no difference in the number of podcasts participants reported listening to by device .
-RESULTS	There were more Twitter posts by mobile app users ( 5111 ) than Twitter website users ( 236 , p < 0.05 ) .
-RESULTS	There was a trend ( p = 0.055 ) in greater weight loss among mobile users for podcasts ( -3.50.5 % ) as compared to non-mobile users ( -2.50.5 % ) .
-RESULTS	Weight loss was significantly greater in Twitter mobile app users ( -5.60.9 % ) than website users ( -2.20.5 % , p < 0.01 ) .
-CONCLUSIONS	Type of device used for podcast listening did not affect engagement but there was a trend toward greater weight loss among mobile users .
-CONCLUSIONS	Method of Twitter posting was associated with engagement and weight loss with mobile app users posting more to Twitter and losing more weight .
-
-###25163948
-OBJECTIVE	To compare outcome after total hip arthroplasty ( THA ) through the mini-incision approach versus the standard transgluteal approach .
-METHODS	80 women and 63 men aged 33 to 89 ( mean , 62 ) years with primary osteoarthritis of the hip were randomised to undergo unilateral THA through a mini-incision approach ( Micro-hip , n = 55 ) or standard , lateral , transgluteal approach ( Bauer , n = 88 ) .
-METHODS	Levels of haemoglobin , haematocrit , serum creatine kinase , and C-reactive protein , length of hospital stay , mobilisation , and any complication were recorded .
-METHODS	Visual analogue scale ( VAS ) for pain was assessed .
-METHODS	Hip function was assessed using the Harris Hip Score and the Oxford Hip Score , whereas general health was assessed using the EQ-5D general health questionnaire .
-METHODS	The cup inclination and varus/valgus of the stem position were measured using a goniometer .
-RESULTS	The Micro-hip group achieved a significantly lower mean incision length ( 9.3 vs. 13.4 cm , p < 0.001 ) , mean surgical time ( 60 vs. 68 minutes , p = 0.021 ) , mean reduction in haemoglobin level ( 2.1 vs. 2.8 g/dl , p < 0.001 ) , and mean VAS for pain from hour 6 to day 6 ( all p < 0.05 ) .
-RESULTS	One patient in the Micro-hip group developed early aseptic loosening of the cup and underwent revision surgery at month 4 .
-RESULTS	Three patients in the Bauer group and one patient in the Micro-hip group sustained intra-operative nondisplaced fractures of the proximal femur , which were fixed with cerclages .
-RESULTS	Two patients in the Microhip group developed deep vein thrombosis during week 1 .
-CONCLUSIONS	THA through the Micro-hip approach achieved faster pain relief .
-
-###25511185
-BACKGROUND	Chronic low back pain ( LBP ) and neck pain ( NP ) are highly prevalent conditions resulting in high economic costs .
-BACKGROUND	Treatment guidelines recommend relaxation techniques , such as progressive muscle relaxation , as adjuvant therapies .
-BACKGROUND	Self-care interventions could have the potential to reduce costs in the health care system , but their effectiveness , especially in a usual care setting , is unclear .
-BACKGROUND	The aim of these two pragmatic randomized studies is to evaluate whether an additional app-delivered relaxation is more effective in the reduction of chronic LBP or NP than usual care alone .
-METHODS	Each pragmatic randomized two-armed study aims to include a total of 220 patients aged 18 to 65 years with chronic ( > 12 weeks ) LBP or NP and an average pain intensity of4 on a numeric rating scale ( NRS ) in the 7 days before recruitment .
-METHODS	The participants will be randomized into an intervention and a usual care group .
-METHODS	The intervention group will be instructed to practice one of these 3 relaxation techniques on at least 5 days/week for 15 minutes/day over a period of 6 months starting on the day of randomization : autogenic training , mindfulness meditation , or guided imagery .
-METHODS	Instructions and exercises will be provided using a smartphone app , baseline information will be collected using paper and pencil .
-METHODS	Follow-up information ( daily , weekly , and after 3 and 6 months ) will be collected using electronic diaries and questionnaires included in the app .
-METHODS	The primary outcome measure will be the mean LBP or NP intensity during the first 3 months of intervention based on daily pain intensity measurements on a NRS ( 0 = no pain , 10 = worst possible pain ) .
-METHODS	The secondary outcome parameters will include the mean pain intensity during the first 6 months after randomization based on daily measurements , the mean pain intensity measured weekly as the average pain intensity of the previous 7 days over 3 and 6 months , pain acceptance , ` LBP - and NP-related ' stress , sick leave days , pain medication intake , adherence , suspected adverse reaction , and serious adverse events .
-CONCLUSIONS	The designed studies reflect a usual self-care setting and will provide evidence on a pragmatic self-care intervention that is easy to combine with care provided by medical professionals .
-BACKGROUND	ClinicalTrials.gov identifier Relaxback NCT02019498 , Relaxneck NCT02019134 registered on 18 December 2013 .
-
-###25092964
-BACKGROUND	Migraine is a painful neurological disorder that affects over 10 % of the general population .
-BACKGROUND	Frovatriptan and rizatriptan are antimigraine agents belonging to the triptan class .
-BACKGROUND	Although previous studies have independently compared the efficacy of these agents , contemporaneous data examining both pharmacokinetic ( PK ) properties and efficacy in parallel have not previously been available .
-METHODS	In this single-center double-blind study , 18 subjects ( ten female ) were treated for a single migraine attack with frovatriptan 2.5 mg or rizatriptan 10 mg .
-METHODS	Plasma concentrations were measured predose and at 2 , 4 , 6 , 12 , 24 , 48 , and 72 hours after drug administration .
-METHODS	The primary end point of this study was to evaluate the association between PK parameters and efficacy measures and recurrence rate .
-METHODS	Secondary end points were pain-free and pain-relief episodes at 2 and 4 hours , recurrent episodes within 48 hours , and cumulative hazard of recurrence within 72 hours .
-RESULTS	At baseline , approximately 17 % of patients had mild migraine , while 83 % had moderate-severe migraine .
-RESULTS	Although the time to maximum concentration was similar for both drugs ( 2.7 versus 2.3 hours ) , the terminal half-life for frovatriptan was longer than rizatriptan ( 29.3 versus 3.2 hours , P < 0.0001 ) .
-RESULTS	The proportion of patients who were pain-free at 4 hours without rescue medication was higher in the frovatriptan-treated group , ( 38.9 versus 5.6 % , P = 0.045 ) .
-RESULTS	The cumulative hazard of recurrence over 72 h was reduced by frovatriptan compared to rizatriptan-treated patients ( log-rank test , P = 0.04 ) .
-RESULTS	Pain-free and pain-relief episodes for the study period were positively correlated with the concentration : maximum concentration ( Cmax ) ratio for frovatriptan ( r = 0.52 , P = 0.028 ) , but not rizatriptan .
-RESULTS	Recurrence rate was negatively correlated with the concentration : Cmax ratio for both frovatriptan ( r = -0.96 , P = 0.0024 ) and rizatriptan ( r = -0.98 , P = 0.0004 ) .
-RESULTS	Fewer adverse events were observed for frovatriptan compared to rizatriptan ( one versus eight , P = 0.021 ) .
-CONCLUSIONS	This pilot study indicates that a similar extent of initial pain relief is afforded by both triptans in migraine treatment .
-CONCLUSIONS	The longer duration of action of frovatriptan parallels and correlates with its PK profile .
-
-###25667159
-OBJECTIVE	The 2010 guidelines recommend new requirements of the chest compression depth for infant .
-OBJECTIVE	The compression technique recommendation for infant remains the 2-finger ( TF ) technique for lone rescuer and the 2-thumb-encircling hands technique for 2 rescuers .
-OBJECTIVE	We hypothesized that the TF technique can not result in an enough compression depth to meet the guideline requirements and that the 2-thumb-encircling hands technique will not affect the ventilation .
-METHODS	Crossover experimental study randomizes 27 health care providers to perform 2 sets of 5-minute cardiopulmonary resuscitation using a 30:2 compression/ventilation ratio to compare TF and 2-thumb-encircling hands techniques .
-METHODS	A Laerdal Resusci Baby QCPR manikin equipped with PC SkillReporting System was used for measuring and recording cardiopulmonary resuscitation data .
-METHODS	Data ( mean SD ) were analyzed by using a paired t test .
-METHODS	Significance was defined qualitatively as P .05 .
-RESULTS	Mean compression depths were 39.25 3.06 cm in the TF technique and 42.37 1.15 cm in the 2-thumb-encircling hands technique , P < .001 .
-RESULTS	Two-finger technique had significant lower fractions of correct hand position than 2-thumb-encircling hands technique ( 96.56 % 6.74 % vs 99.41 % 2.52 % , P < .05 ) .
-RESULTS	The fatigue point appears much earlier in TF than in 2-thumb-encircling hands .
-RESULTS	No difference was identified on ventilation between 2 groups .
-CONCLUSIONS	The 2-thumb-encircling hands technique can produce a compression depth meeting the current guidelines recommendation without negative influence on ventilation , whereas the TF technique can not .
-CONCLUSIONS	The 2-thumb-encircling hands technique generates a significant higher ratio of correct compression position than the TF technique .
-CONCLUSIONS	Furthermore , the 2-thumb-encircling hands technique is less fatiguing than the TF technique .
-
-###24640801
-OBJECTIVE	To evaluate the biochemical changes associated with succinylcholine administration after pretreatment with rocuronium at different time intervals .
-METHODS	The prospective , randomised , single-blinded study was conducted at the Combined Military Hospital , Rawalpindi , from January to May 2010 .
-METHODS	Ninety male , aged 18-60 years , American Society of Anaesthesiology I or II patients undergoing elective inguinal herniotomy or external haemorrhoidectomy were included .
-METHODS	The patients were randomly divided into three equal groups .
-METHODS	Group A received a normal saline 5 ml as placebo 1 minute before succinylcholine ; Group B received rocuronium 0.06 mg/kg 1 intravenously minute before succinylcholine , while Group C received intravenous injection of rocuronium 0.06 mg/kg 5 minute before succinylcholine .
-METHODS	Venous blood samples for creatinine phosphokinase , lactate dehydrogenase and myoglobin plasma concentrations were obtained at 0 , 30 minutes , 6 hours and 24 hours after succinylcholine administration .
-RESULTS	Mean serum creatinine phosphokinase and myoglobin concentrations were significantly decreased in Groups B and C compared to Group A at 30 minutes and 24 hours ( p < 0.05 ) .
-RESULTS	However , no significant difference in the enzyme levels at any time interval was observed among the rocuronium groups .
-RESULTS	There was a significant rise in lactate dehydrogenase concentrations at 6 hours and 24 hours in Group A compared to Groups B and C ( p < 0.05 ) .
-CONCLUSIONS	Pretreatment with rocuronium effectively reduces the biochemical changes associated with succinylcholine-induced muscle fasciculations .
-CONCLUSIONS	However , whether it is given 1 minute or 5 minutes before succinylcholine does not make much difference .
-
-###24866311
-OBJECTIVE	Obesity in children and adolescents is associated to a morbidity that has increased significantly .
-OBJECTIVE	It has become a public health problem around the world .
-OBJECTIVE	The objective of this paper was to evaluate the efficacy of the cognitive behavioral treatment strategy in the comprehensive management of obesity in adolescents .
-METHODS	Double blind , randomized , and controlled intervention study , of four months of follow-up , with a total of 115 obese adolescents , aged 12 to 16 years .
-METHODS	The intervention group received cognitive behavioral treatment strategy , as well as advise on diet and exercise .
-METHODS	At the same time , the control group only received advise on diet and exercise .
-RESULTS	The percentage of adolescents who showed adherence to diet was 73.7 % versus 41.4 % , ( p = 0.0009 ) and to exercise , 61.4 % versus 19.0 % , ( p < 0.0005 ) ; compared with the control group , the intervention group was significantly higher .
-RESULTS	A total of 10 adolescents ( 17.5 % ) in the intervention group and 26 ( 44.8 % ) in the control group dropped-out ( p = 0.003 ) .
-RESULTS	Despite there were significant differences between groups , adolescents in the intervention group exhibited a higher and sustained decrease in body weight , body mass index , as well as in the body fat percentage .
-CONCLUSIONS	The cognitive behavioral treatment strategy improves adherence and decreases desertion of the weight reduction program in adolescents .
-
-###24260129
-OBJECTIVE	The present study aimed to investigate the prevalence and correlates of dental caries in elderly population in northeast China .
-METHODS	A community-based , cross-sectional study among 2376 elderly subjects ( age : 65-74 years ) from nine urban areas and nine rural areas in three provinces of northeast China was conducted using multistage stratified random sampling per the World Health Organization oral health survey methodology .
-METHODS	Decayed-missing-filled teeth ( DMFT ) and decayed-filled teeth ( DFT ) indices were used to evaluate the prevalence of dental caries .
-METHODS	Face-to-face questionnaire survey on oral health was performed in a randomly selected subset ( n = 1197 ) .
-METHODS	T test and chi square test were employed to compare groups for continuous and categorical variables , respectively .
-METHODS	Multivariate logistic regression was used to estimate odds ratios ( ORs ) and corresponding confidence intervals ( CIs ) .
-RESULTS	67.5 % of elderly subjects reported dental caries ( average DFT = 2.683.40 ) , and the prevalence was higher in urban areas ( P < 0.01 ) .
-RESULTS	Missing teeth accounted for 80.72 % of DMFT , and filled teeth due to caries accounted for 2.08 % with a rate higher in urban areas ( P < 0.01 ) .
-RESULTS	Logistic regression analysis indicated significant association among elderly population in urban areas ( OR 1.713 ; 95 % CI 1.337-2 .195 ) , smoking ( OR 1.779 ; 95 % CI 1.384-2 .288 ) , and individuals without dental insurance ( OR 2.050 ; 95 % CI 1.120-3 .754 ) with dental caries .
-CONCLUSIONS	The prevalence of dental caries in the elderly population in northeast China is high .
-CONCLUSIONS	The elderly from urban areas who smoke and who do not have a dental insurance are at a higher risk to develop dental caries .
-
-###24796043
-OBJECTIVE	To observe the short-term and long-term efficacies on primary dysmenorrhea treated with staging acupoint embedment therapy .
-METHODS	Seventy cases of primary dysmenorrhea were randomized into an embedment therapy group and a fenbid group , 35 cases in each one .
-METHODS	In the embedment therapy group , the embedment therapy was applied twice during the menstrual cycle , one treatment 3 days before menstruation and one treatment during the 12th-14th days of menstruation , respectively .
-METHODS	Guanyuan ( CV 4 ) , Zigong ( EX-CA 1 ) , Diji ( SP 8 ) and Ciliao ( BL 32 ) were the main acupoints in the treatment 3 days before menstruation .
-METHODS	Shenshu ( BL 23 ) , Ganshu ( BL 18 ) and Pishu ( BL 20 ) were the main acupoints in the treatment during menstruation .
-METHODS	In the fenbid group , fenbid was prescribed for oral administration , 0.3 g each time , twice a day , starting 3 days before menstruation till pain was relieved .
-METHODS	The treatment of one menstrual cycle was one session .
-METHODS	The continuous treatment of 3 menstrual cycles was required .
-METHODS	The short-term and long-term efficacies were evaluated at the end of the 3rd cycle and in 3 months after the treatment terminal .
-METHODS	The dysmenorrhea score was used to evaluate the efficacy .
-METHODS	Visual analogue scale ( VAS ) and SF-36 were for the assessment of pain degree and life quality .
-RESULTS	( 1 ) The total effective rate was 91.4 % ( 32/35 ) in the embedment therapy group after the 3 menstrual cycles , which was better than 74.3 % ( 26/35 ) in the fenbid group ( P < 0.01 ) .
-RESULTS	In the follow-up stage , the total effective rate was 91.4 % ( 32/35 ) in the embedment therapy group , which was better than 40.0 % ( 14/35 ) in the fenbid group ( P < 0.01 ) .
-RESULTS	( 2 ) The differences were not significant in dysmenorrhea score and VAS score after the 1st and 2nd menstrual cycle treatments between the two groups ( all P > 0.05 ) .
-RESULTS	In the 3rd menstrual cycle and the follow-up stage , the dysmenorrhea score and VAS score were reduced obviously in the embedment therapy group as compared with those in the fenbid group ( P < 0.05 , P < 0.01 ) .
-RESULTS	The rebound effect occurred in the follow-up stage in the fenbid group .
-RESULTS	( 3 ) In the 3rd menstrual cycle and the follow-up stage , the improvement in the total score of life quality of the embedment therapy group was superior apparently to the fenbid group ( P < 0.05 , P < 0.01 ) .
-CONCLUSIONS	The staging acupoint embedment therapy achieves the superior short-term and long-term efficacies as compared with the oral administration of fenbid in the treatment of primary dysmenorrhea .
-CONCLUSIONS	As the symptoms of dysmenorrhea and pain are relieved , the life quality is improved .
-
-###24439238
-BACKGROUND	In-patient treatment ( IP ) is the treatment setting of choice for moderately-to-severely ill adolescents with anorexia nervosa , but it is costly , and the risks of relapse and readmissions are high .
-BACKGROUND	Day patient treatment ( DP ) is less expensive and might avoid problems of relapse and readmission by easing the transition from hospital to home .
-BACKGROUND	We investigated the safety and efficacy of DP after short inpatient care compared with continued IP .
-METHODS	For this multicentre , randomised , open-label , non-inferiority trial , we enrolled female patients ( aged 11-18 years ) with anorexia nervosa from six centres in Germany .
-METHODS	Patients were eligible if they had a body-mass index ( BMI ) below the tenth percentile and it was their first admission to hospital for anorexia nervosa .
-METHODS	We used a computer-generated randomisation sequence to randomly assign patients to continued IP or DP after 3 weeks of inpatient care ( 1:1 ; stratified for age and BMI at admission ) .
-METHODS	The treatment programme and treatment intensity in both study groups were identical .
-METHODS	The primary outcome was the increase in BMI between the time of admission and a 12-month follow-up adjusted for age and duration of illness ( non-inferiority margin of 075 kg/m ( 2 ) ) .
-METHODS	Analysis was done by modified intention to treat .
-METHODS	This trial is registered with the International Standard Randomised Controlled Trial Number Register , number ISRCTN67783402 , and the Deutsches Register Klinischer Studien , number DRKS00000101 .
-RESULTS	Between Feb 2 , 2007 , to April 27 , 2010 , we screened 660 patients for eligibility , 172 of whom we randomly allocated to treatment : 85 to IP and 87 to DP .
-RESULTS	DP was non-inferior to IP with respect to the primary outcome , BMI at the 12-month follow-up ( mean difference 046 kg/m ( 2 ) in favour of DP ( 95 % CI , -011 to 102 ; pnon-inferiority < 00001 ) .
-RESULTS	The number of treatment-related serious adverse events was similar in both study groups ( eight in the IP group , seven in the DP group ) .
-RESULTS	Three serious adverse events in the IP group and two in the DP group were related to suicidal ideation ; one patient in the DP attempted suicide 3 months after she was discharged .
-CONCLUSIONS	DP after short inpatient care in adolescent patients with non-chronic anorexia nervosa seems no less effective than IP for weight restoration and maintenance during the first year after admission .
-CONCLUSIONS	Thus , DP might be a safe and less costly alternative to IP .
-CONCLUSIONS	Our results justify the broad implementation of this approach .
-BACKGROUND	German Ministry for Education and Research .
-
-###25137243
-OBJECTIVE	Sleep disturbances are common among women in midlife ; prevalence increases among perimenopausal/postmenopausal women with vasomotor symptoms .
-OBJECTIVE	Paroxetine 7.5 mg is the only nonhormonal treatment that has been approved in the United States for moderate to severe vasomotor symptoms associated with menopause .
-OBJECTIVE	In two pivotal phase 3 studies evaluating its efficacy and safety , improvements in sleep disturbances were also prospectively evaluated .
-METHODS	Postmenopausal women with moderate to severe vasomotor symptoms were randomly assigned to paroxetine 7.5 mg ( n = 591 ) or placebo ( n = 593 ) once daily for 12 weeks ( both studies ) or 24 weeks ( 24-wk study ) .
-METHODS	Predefined assessments on weeks 4 , 12 , and 24 included number of nighttime awakenings attributed to vasomotor symptoms , sleep-onset latency , sleep duration , and sleep-related adverse events .
-METHODS	The two studies ' data for weeks 1 to 12 were pooled .
-RESULTS	At baseline , participants reported a mean of 3.6 awakenings/night attributed to vasomotor symptoms .
-RESULTS	Nighttime awakenings attributed to vasomotor symptoms were significantly reduced within 4 weeks of initiating paroxetine 7.5 mg treatment ( 39 % reduction vs 28 % for placebo ; P = 0.0049 ) , and reductions were sustained through 12 or 24 weeks of treatment .
-RESULTS	Paroxetine 7.5 mg treatment also significantly increased nighttime sleep duration ( week 4 , +31 vs +16 min for placebo ; P = 0.0075 ) , but no significant between-group differences in sleep-onset latency or sleep-related adverse events such as sedation were observed .
-CONCLUSIONS	In postmenopausal women treated for menopausal vasomotor symptoms , paroxetine 7.5 mg significantly reduces the number of nighttime awakenings attributed to vasomotor symptoms and increases sleep duration without differentially affecting sleep-onset latency or sedation .
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-###24335055
-BACKGROUND	The maximal calcium absorption in response to vitamin D has been proposed as a biomarker for vitamin D sufficiency .
-OBJECTIVE	The objective was to determine whether there is a threshold beyond which increasing doses of vitamin D , or concentrations of serum 25-hydroxyvitamin D [ 25 ( OH ) D ] , no longer increase calcium absorption .
-METHODS	This was a placebo-controlled , dose-response , randomized , double-blind study of the effect of vitamin D on calcium absorption in healthy postmenopausal women .
-METHODS	Seventy-six healthy postmenopausal women were randomly assigned to placebo or 800 IU ( 20 g ) , 2000 IU ( 50 g ) , or 4000 IU ( 100 g ) vitamin D for 8 wk .
-METHODS	The technique of dual isotopes of stable calcium was used with a calcium carrier to measure calcium absorption at baseline and after 8 wk .
-RESULTS	Seventy-one women with a mean SD age of 58.8 4.9 y completed the study .
-RESULTS	The mean calcium intake was 1142 509 mg/d and serum 25 ( OH ) D was 63 14 nmol/L at baseline .
-RESULTS	A statistically significant linear trend of an increase in calcium absorption adjusted for age and body mass index with increasing vitamin D dose or serum 25 ( OH ) D concentration was observed .
-RESULTS	A 6.7 % absolute increase in calcium absorption was found in the highest vitamin D group ( 100 g ) .
-RESULTS	No evidence of nonlinearity was observed in the dose-response curve .
-CONCLUSIONS	No evidence of a threshold of calcium absorption was found with a serum 25 ( OH ) D range from 40 to 130 nmol/L .
-CONCLUSIONS	Calcium absorption in this range is not a useful biomarker to determine nutritional recommendations for vitamin D.
-
-###24274190
-BACKGROUND	In the paediatric population , pain and distress associated with burn injuries during wound care procedures remain a constant challenge .
-BACKGROUND	Although silver dressings are the gold standard for burn care in Australasia , very few high-level trials have been conducted that compare silver dressings to determine which will provide the best level of care clinically .
-BACKGROUND	Therefore , for paediatric patients in particular , identifying silver dressings that are associated with lower levels of pain and rapid wound re-epithelialisation is imperative .
-BACKGROUND	This study will determine whether there is a difference in time to re-epithelialisation and pain and distress experienced during wound care procedures among Acticoat , Acticoat combined with Mepitel and Mepilex Ag dressings for acute , paediatric partial thickness burns .
-METHODS	Children aged 0 to 15 years with an acute partial thickness ( superficial partial to deep partial thickness inclusive ) burn injury and a burn total body surface area of 10 % will be eligible for the trial .
-METHODS	Patients will be randomised to one of the three dressing groups : ( 1 ) Acticoat or ( 2 ) Acticoat combined with Mepitel or ( 3 ) Mepilex Ag .
-METHODS	A minimum of 28 participants will be recruited for each treatment group .
-METHODS	Primary measures of pain , distress and healing will be repeated at each dressing change until complete wound re-epithelialisation occurs or skin grafting is required .
-METHODS	Additional data collected will include infection status at each dressing change , physical function , scar outcome and scar management requirements , cost effectiveness of each dressing and staff perspectives of the dressings .
-CONCLUSIONS	The results of this study will determine the effects of three commonly used silver and silicone burn dressing combinations on the rate of wound re-epithelialisation and pain experienced during dressing procedures in acute , paediatric partial thickness burn injuries .
-BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12613000105741 .
-
-###24955739
-OBJECTIVE	To evaluate the efficacy of valproic acid ( VPA ) on visual function in patients with retinitis pigmentosa ( RP ) .
-METHODS	Thirty patients ( 60 eyes ) with typical RP were recruited for the study .
-METHODS	Of these , 15 patients received oral VPA ( 500mg once daily ) for a period of 1 year ( group 1 ) and the remaining 15 received no treatment ( group 2 ) and served as controls .
-METHODS	The effect of VPA on visual function was determined in terms of visual acuity , amplitude and implicit time in multifocal electroretinography ( mfERG ) , and visual evoked response ( VER ) performed at presentation and at the third month , sixth month , and 1 year in both groups .
-METHODS	Side effects of oral VPA were also monitored .
-RESULTS	At 1-year follow-up , 14 of 15 patients in group 1 had improvement in median best corrected visual acuity ( BCVA ) from 1.8 [ Range ( R ) 1-3 ] at baseline to 1.3 ( R , 0.6-1 .3 ) ( P < 0.001 ) .
-RESULTS	In contrast , there was a slight decrease in median BCVA from 1.8 ( 0.8 - 3 ) logarithm of the minimum angle of resolution ( logMAR ) at baseline to 1.83 ( P = 0.3 ) in the control arm .
-RESULTS	There was also a statistically significant increase in improvement in amplitude and latency/implicit time in mfERG and VER in this group ( P < 0.001 ) .
-RESULTS	However , no such improvement was observed in the control arm .
-CONCLUSIONS	Thus , VPA seems to have a positive effect on the visual functions in RP patients .
-CONCLUSIONS	Long-term studies evaluating the dose modifications , genetic analysis , and change in visual fields will add to our current knowledge .
-
-###24748778
-OBJECTIVE	Delirium is associated with poor outcomes following acute hospitalization .
-OBJECTIVE	The Geriatric Monitoring Unit ( GMU ) is a specialized five-bedded unit for acute delirium care .
-OBJECTIVE	It is modeled after the Delirium Room program , with adoption of core interventions from the Hospital Elder Life Program and use of evening light therapy to consolidate circadian rhythms and improve sleep in older inpatients .
-OBJECTIVE	This study examined whether the GMU program improved outcomes in delirious patients .
-METHODS	A total of 320 patients , including 47 pre-GMU , 234 GMU , and 39 concurrent control subjects , were studied .
-METHODS	Clinical characteristics , cognitive status , functional status ( Modified Barthel Index [ MBI ] ) , and chemical restraint-use data were obtained .
-METHODS	We also looked at in-hospital complications of falls , pressure ulcers , nosocomial infection rate , and discharge destination .
-METHODS	Secondary outcomes of family satisfaction ( for the GMU subjects ) were collected .
-RESULTS	There were no significant demographic differences between the three groups .
-RESULTS	Pre-GMU subjects had longer duration of delirium and length of stay .
-RESULTS	MBI improvement was most evident in the GMU compared with pre-GMU and control subjects ( 19.218.3 , 7.511.2 , 15.118.0 , respectively ) ( P < 0.05 ) .
-RESULTS	The GMU subjects had a zero restraint rate , and pre-GMU subjects had higher antipsychotic dosages .
-RESULTS	This translated to lower pressure ulcer and nosocomial infection rate in the GMU ( 4.1 % and 10.7 % , respectively ) and control ( 1.3 % and 7.7 % , respectively ) subjects compared with the pre-GMU ( 9.1 % and 23.4 % , respectively ) subjects ( P < 0.05 ) .
-RESULTS	No differences were observed in mortality or discharge destination among the three groups .
-RESULTS	Caregivers of GMU subjects felt the multicomponent intervention to be useful , with scheduled activities voted the most beneficial in patient 's recovery from the delirium episode .
-CONCLUSIONS	This study shows the benefits of a specialized delirium management unit for older persons .
-CONCLUSIONS	The GMU model is thus a relevant system of care for rapidly `` graying '' nations with high rates of frail elderly hospital admissions , which can be easily transposed across acute care settings .
-
-###24820498
-OBJECTIVE	To study the value of contrast-enhanced ultrasound in tuberculous cervical lymph node biopsy .
-METHODS	Seventy-nine patients with cervical lymph node were divided into two groups .
-METHODS	The lymph nodes of group A were used as real-time ultrasound guided biopsy ; the lymph nodes of group B were contrast-enhanced ultrasound firstly to determine the target lymph node and the puncture point , then were detected with needle biopsy .
-RESULTS	Group A : for the 23 lymph nodes of 23 patients , the rate of intact tissue was 52.1 % and the positive rate of pathological diagnosis was 73.9 % .
-RESULTS	Group B : for the 56 lymph nodes of 56 patients , the rate of intact tissue was 98.2 % and the positive rate of pathological diagnosis was 100 % ( Chi square value was 23.37 and 12.31 , P < 0.05 ) .
-CONCLUSIONS	The application of contrast-enhanced ultrasound before cervical lymph node biopsy can obviously improve the rate of intact tissue and the positive rate of pathological diagnosis .
-
-###24490058
-BACKGROUND	Few safe and effective dietary supplements are available to promote weight loss .
-BACKGROUND	We evaluated the safety and efficacy of glucomannan , a water-soluble fiber supplement , for achieving weight loss in overweight and moderately obese individuals consuming self-selected diets .
-METHODS	Participants were randomly assigned to take 1.33 grams of glucomannan or identically looking placebo capsules with 236.6 mL ( 8 ounces ) of water one hour before breakfast , lunch , and dinner for 8 weeks .
-METHODS	The primary efficacy outcome was change in body weight after 8 weeks .
-METHODS	Other efficacy outcomes were changes in body composition , hunger/fullness , and lipid and glucose concentrations .
-METHODS	Safety outcomes included gastrointestinal symptoms/tolerance and serum liver enzymes and creatinine levels .
-RESULTS	A total of 53 participants ( 18-65 years of age ; BMI 25-35kg / m ) were enrolled and randomized .
-RESULTS	The two groups did not differ with respect to baseline characteristics and compliance with the study supplement .
-RESULTS	At 8 weeks , there was no significant difference between the glucomannan and placebo groups in amount of weight loss ( -.40 .06 and -.43 .07 , resp . )
-RESULTS	or other efficacy outcomes or in any of the safety outcomes .
-CONCLUSIONS	Glucomannan supplements administered over 8 weeks were well tolerated but did not promote weight loss or significantly alter body composition , hunger/fullness , or lipid and glucose parameters .
-CONCLUSIONS	This trial is registered with NCT00613600 .
-
-###25125001
-OBJECTIVE	To assess daily functioning and geriatric conditions of older subjects suffering from heart failure ( HF ) as compared to the general population .
-RESULTS	The data were collected as part of the nationwide PolSenior project ( 2007-2011 ) .
-RESULTS	Of 4979 individuals ( age range 65-104 years ) , data on self-reported HF hospitalization were available for 4795 subjects ( 96 % ) .
-RESULTS	Geriatric assessment ( GA ) included functional status ( ADL , Activities of Daily Living and IADL , Instrumental ADL scales ) , cognitive function , mood disorders , sensory organ impairment , falls and comorbidity .
-RESULTS	Mean age SD of the study population was 73.8 6.5 years ; 62 % were female .
-RESULTS	The proportion of subjects with HF hospitalizations increased from 8 % in subjects aged 65-69 years up to 13 % in the age group of 85-89 years , and decreased in nonagenarians ( 11 % ) .
-RESULTS	Subjects with the HF hospitalization were older , used more drugs , and were characterized by a higher prevalence of comorbid conditions , mood disorders , hearing impairment and functional limitations .
-RESULTS	In logistic regression , HF hospitalization increased the age-sex adjusted risk of disability by 40 % , both in ADL and IADL .
-RESULTS	After adjustment to other clinical and geriatric conditions , HF hospitalization remained an independent predictor of disability in both ADL ( OR = 1.36 , 95 % CI : 1.00-1 .84 ) and IADL ( OR = 1.40 , 95 % CI : 1.01-1 .93 ) .
-CONCLUSIONS	Older people who reported HF admissions had a higher number of comorbidities and geriatric conditions : mood disorders , hearing impairment and functional limitations .
-CONCLUSIONS	Besides , in our study , HF hospitalization independently and significantly increased the risk of limitations in IADL and ADL .
-CONCLUSIONS	Therefore , further studies are needed to evaluate the benefits of GA in patients with HF .
-
-###24893655
-BACKGROUND	The course of swine influenza in pigs is reported to be similar to human influenza .
-BACKGROUND	Occasionally abortions and other reproduction disorders have been associated with influenza A virus ( IAV ) infection in pigs .
-BACKGROUND	Abortions may be a consequence of high fever , pro-inflammatory cytokines or transplacental transmission of the virus.The role of IAV in the complications observed during pregnancy has been scanty and the true importance of this agent as a cause of reproductive problems in swine is not known .
-BACKGROUND	The aim was to determine the possible involvement of swine H1N2 IAV strain on reproductive disorders in pregnant gilts under experimental conditions .
-RESULTS	The gestation length was from 113 to 116 days , no abortion or any other reproduction disorders were noted .
-RESULTS	A PCR assay confirms the presence of IAV in the nasal swabs taken from inoculated gilts between 1 and 5 dpi .
-RESULTS	In the nasal swabs from control gilts and newborn piglets , no IAV genetic material was found .
-RESULTS	No viral RNA was detected in samples of blood taken from gilts and piglets , placentas , lungs and tracheas taken from piglets euthanized after delivery .
-RESULTS	The significant decrease in the number and percentage of lymphocytes without leukopenia was observed at 4 dpi in inoculated gilts .
-RESULTS	The percentage of granulocytes increased significantly at 4 dpi in inoculated pigs .
-RESULTS	The concentration of IL-6 , IL-10 and TNF - were higher in inoculated gilts , while IL-4 and IFN - were not detected in the serum of any of animals .
-RESULTS	The serum concentrations of C-reactive protein remained stable during study , while haptoglobin concentrations increased significantly after inoculation .
-CONCLUSIONS	The results of the study indicate that infection of pregnant gilts with swine H1N2 IAV in the second month of pregnancy does not cause abortion and other reproduction disorders .
-CONCLUSIONS	No evidence for transplacental transmission of swine H1N2 IAV was found .
-CONCLUSIONS	However , due to subclinical course of influenza in the present experiment caution should be taken in extrapolating these results to the cases of acute influenza .
-CONCLUSIONS	The other limitation is IAV diversity .
-CONCLUSIONS	It can not be excluded that other subtypes of IAV could be associated to reproduction failure in pigs .
-
-###25875131
-OBJECTIVE	Although applying adhesive strips to a wound closure has been shown to have outcomes equivalent to those with cuticular suturing , it is unknown whether adhesive strips provide additional benefit compared with dermal suturing alone .
-OBJECTIVE	To determine whether the addition of adhesive strips to a wound closed with buried interrupted subcuticular sutures improves outcomes following wound closure .
-METHODS	A prospective , randomized split-wound intervention was conducted between November 14 , 2013 , and May 16 , 2014 , in patients who underwent cutaneous surgical procedures at the University of California , Davis , outpatient dermatology clinic .
-METHODS	Fifty-seven patients 18 years or older with postoperative defects of at least 3 cm , resulting from either Mohs micrographic surgical procedures or surgical excision , were screened for participation .
-METHODS	Nine patients were excluded and 48 were enrolled .
-METHODS	Half of each wound was randomized to receive buried interrupted subcuticular sutures and overlying adhesive strips and the other half received buried interrupted subcuticular sutures only .
-METHODS	At 3 months ' follow-up , each patient and 2 blinded observers evaluated the wound using the Patient Observer Scar Assessment Scale .
-RESULTS	The total mean ( SD ) Patient Observer Scar Assessment Scale score for observers for the side that received a combination of adhesive strips and buried interrupted subcuticular suturing ( 12.3 [ 4.8 ] ) and the side that received sutures only ( 12.9 [ 6.3 ] ) did not differ significantly at 3 months ( P = .32 ) .
-RESULTS	There was no significant difference in the total patient assessment scale score between the combination closure ( 14.0 [ 7.6 ] ) and sutures only ( 14.7 [ 7.6 ] ) sides at 3 months ( P = .39 ) .
-RESULTS	There was also no significant difference between the 2 closure methods in terms of mean ( SD ) scar width ( both methods : 1.1 [ 0.8 ] mm , P = .89 ) at follow-up .
-CONCLUSIONS	Combination closure with adhesive strips and buried interrupted subcuticular suturing was not significantly associated with improved overall scar assessment compared with buried interrupted subcuticular suturing alone when evaluated by blinded observers or the patients themselves .
-CONCLUSIONS	Our results do not support the use of adhesive strips as a means to improve cosmetic outcomes or reduce scar width .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01979497 .
-
-###25592014
-OBJECTIVE	The aim of this study was to determine the effect of plant-based diets on weight loss .
-METHODS	Participants were enrolled in a 6-mo , five-arm , randomized controlled trial in 2013 in South Carolina .
-METHODS	Participants attended weekly group meetings , with the exception of the omnivorous group , which served as the control and attended monthly meetings augmented with weekly e-mail lessons .
-METHODS	All groups attended monthly meetings for the last 4 mo of the study .
-METHODS	Diets did not emphasize caloric restriction .
-RESULTS	Overweight adults ( body mass index 25-49 .9 kg/m ( 2 ) ; age 18-65 y , 19 % non-white , and 27 % men ) were randomized to a low-fat , low-glycemic index diet : vegan ( n = 12 ) , vegetarian ( n = 13 ) , pesco-vegetarian ( n = 13 ) , semi-vegetarian ( n = 13 ) , or omnivorous ( n = 12 ) .
-RESULTS	Fifty ( 79 % ) participants completed the study .
-RESULTS	In intention-to-treat analysis , the linear trend for weight loss across the five groups was significant at both 2 ( P < 0.01 ) and 6 mo ( P < 0.01 ) .
-RESULTS	At 6 mo , the weight loss in the vegan group ( -7.5 % 4.5 % ) was significantly different from the omnivorous ( -3.1 % 3.6 % ; P = 0.03 ) , semi-vegetarian ( -3.2 % 3.8 % ; P = 0.03 ) , and pesco-vegetarian ( -3.2 % 3.4 % ; P = 0.03 ) groups .
-RESULTS	Vegan participants decreased their fat and saturated fat more than the pesco-vegetarian , semi-vegetarian , and omnivorous groups at both 2 and 6 mo ( P < 0.05 ) .
-CONCLUSIONS	Vegan diets may result in greater weight loss than more modest recommendations .
-
-###26059337
-OBJECTIVE	To assess the safety and efficacy of pitavastatin in children and adolescents with hyperlipidemia .
-METHODS	A total of 106 children and adolescents with hyperlipidemia , ages 6 to 17 years , were enrolled in a 12-week randomized , double-blind , placebo-controlled study and randomly assigned to pitavastatin 1 mg , 2 mg , 4 mg , or placebo .
-METHODS	During a 52-week extension period , subjects were up-titrated from 1 mg pitavastatin to a maximum dose of 4 mg in an effort to achieve an optimum low-density lipoprotein cholesterol ( LDL-C ) treatment target of < 110 mg/dL ( 2.8 mmol/L ) .
-METHODS	Adverse events rates , including abnormal clinical laboratory variables , vital signs , and physical examination were assessed .
-RESULTS	Compared with placebo , pitavastatin 1 , 2 , and 4 mg significantly reduced LDL-C from baseline by 23.5 % , 30.1 % , and 39.3 % , respectively , and in the open-label study 20.5 % of the subjects reached the LDL-C goal < 110 mg/dL ( 2.8 mmol/L ) .
-RESULTS	No safety issues were evident .
-CONCLUSIONS	Pitavastatin at doses up to 4 mg is well tolerated and efficacious in children and adolescents aged 6-17 years .
-BACKGROUND	Registered with EudraCT 2011-004964-32 and EudraCT 2011-004983-32 .
-
-###24633376
-OBJECTIVE	Speech perception is the most important social task of the auditory system .
-OBJECTIVE	Consequently , speech audiometry is essential to evaluate hearing aid benefit .
-OBJECTIVE	The aim of the study was to describe the correlation between pure-tone hearing loss and speech perception .
-OBJECTIVE	In particular , pure-tone audiogram , speech audiogram , and speech perception with hearing aids were compared .
-METHODS	In a retrospective study , 102 hearing aid users with bilateral sensorineural hearing loss were included .
-METHODS	Pure-tone loss ( PTA ) was correlated to monosyllabic perception at 65 dB with hearing aid and with maximum monosyllabic perception with headphones .
-RESULTS	Speech perception as a function of hearing loss can be represented by a sigmoid function .
-RESULTS	However , for higher degrees of hearing loss , substantial deviations are observed .
-RESULTS	Maximum monosyllabic perception with headphones is usually not achieved with hearing aids at standard speech levels of 65 dB .
-CONCLUSIONS	For larger groups , average pure-tone hearing loss and speech perception correlate significantly .
-CONCLUSIONS	However , prognosis for individuals is not possible .
-CONCLUSIONS	In particular for higher degrees of hearing loss substantial deviations could be observed .
-CONCLUSIONS	Speech performance with hearing aids can not be predicted sufficiently from speech audiograms .
-CONCLUSIONS	Above the age of 80 , speech perception is significantly worse .
-
-###24655978
-BACKGROUND	Hyperlipidemia occurs in up to 50 % of kidney transplant ( KT ) recipients who take everolimus ( EVL ) .
-BACKGROUND	As a result of this , statins are the most commonly prescribed lipid-lowering drugs among these patients .
-BACKGROUND	However , we are concerned whether there are any drug interactions between EVL and statins , because both of these drugs use the same pharmacokinetics pathway .
-BACKGROUND	Therefore , we assessed the effects of concomitant use of EVL and atorvastatin .
-METHODS	In this randomized , open-label , crossover study , 20 KT patients were assigned ( 1:1 ) to receive EVL with or without 20 mg atorvastatin for 1 month .
-METHODS	One-month washout period was used before crossover .
-METHODS	Plasma EVL concentrations were measured by homogeneous particle-enhanced turbidimetric immunoassay .
-METHODS	Twelve-hour area under the time-concentration curve ( AUC0-12 ) of EVL was calculated with the use of whole-blood EVL concentrations from 10 different time points ( 0 , 0.5 , 1 , 1.5 , 2 , 2.5 , 4 , 6 , 8 , and 12 hours ) .
-RESULTS	The mean ( SD ) AUC0-12 for EVL and EVL plus atorvastatin was 155.9 ( 41.6 ) ngh/mL and 151.3 ( 51.4 ) ngh/mL , respectively ( P > .05 ; paired t test ) .
-RESULTS	No difference of EVL Cmax or Tmax was found after atorvastatin coadministration .
-RESULTS	Even though the EVL AUC0-12 levels were not affected by atorvastatin coadministration in one-half of the subjects , for the rest of the patients , there were unpredictable changes in the EVL AUC0-12 levels .
-RESULTS	This may be due to the high intrapatient variability of EVL drug concentration ( coefficient of variation ranges from 9.8 % to 34.1 % ) .
-CONCLUSIONS	Coadministration of atorvastatin with EVL in KT recipients did not affect the pharmacokinetics of EVL .
-
-###24289490
-BACKGROUND	Problem-based learning ( PBL ) involves discussions among students who resolve loosely-structured problems to facilitate learning .
-BACKGROUND	In the PBL curriculum , faculty tutors are employed as facilitators for small groups of students .
-BACKGROUND	Because of lack of time and staff shortage , the effectiveness of tutorless PBL has been discussed as an alternate option .
-METHODS	Sessions in which tutored and tutorless PBL groups are mixed were presented by 1st-year medical students , who experienced both tutored and tutorless groups alternately in the two sessions of a year .
-METHODS	To examine the effectiveness of tutored and tutorless PBL , written examination scores ( WES ) and self-contentment scores ( SCS ) were statistically analysed .
-RESULTS	WES averages did not significantly differ between the tutored and tutorless groups ; however , a significantly greater variation was observed in WES in the tutorless group .
-RESULTS	SCS averages tended to be higher in the tutored PBL than in tutorless PBL groups .
-CONCLUSIONS	Students in these tutorless PBL groups performed well in their written examinations , whereas those in the tutored PBL groups , achieved this and reported better self-contentment with their learning experience .
-CONCLUSIONS	Tutorless PBL sessions were considered to be comparable to tutored PBL sessions at least in the early stages .
-
-###24891007
-METHODS	Randomised , double-blind , placebo-controlled crossover trial of melatonin supplementation to people with complete tetraplegia .
-OBJECTIVE	To investigate the effect that 3mg melatonin supplementation has on objective and subjective sleep , quality of life and mood of people living with complete tetraplegia .
-METHODS	Austin Hospital Sleep Laboratory and participants ' homes , Melbourne , Victoria , Australia .
-METHODS	Two week run-in followed by 3 week nightly administration of 3mg melatonin or placebo , 2-week washout and further 3 week administration of the opposite treatment .
-METHODS	Four testing sessions were conducted ; the last nights of the run-in , treatment and washout periods .
-METHODS	Testing sessions involved recording full polysomnography , completing a questionnaire battery and collecting urine and blood samples .
-METHODS	The questionnaires assessed mood , sleep symptoms and health-related quality of life , and the urine and plasma samples assayed 6-sulphatoxymelatonin ( aMT6s ) and melatonin levels , respectively .
-METHODS	A sleep diary was completed throughout the study .
-RESULTS	Eight participants ( mean ( s.d. ) : age 49.5 years ( 16 ) , postinjury 16.9 years ( 7.1 ) ) were recruited in which seven concluded the protocol .
-RESULTS	Endogenous-circulating melatonin was significantly higher ( P < or = 0.01 ) following melatonin ( urine : 152.94 gh ( -1 ) ( 74.51 ) , plasma : 43,554.57 pM ( 33,527.11 ) ) than placebo ( urine : 0.86 gh ( -1 ) ( 0.40 ) , plasma : 152.06 pM ( 190.55 ) ) .
-RESULTS	Subjective sleep improved significantly following melatonin specifically for duration of sleep per night and psychological wellbeing .
-RESULTS	Objective sleep showed a significant increase in light sleep with melatonin , with all other sleep parameters being unchanged .
-CONCLUSIONS	These results suggest that increasing melatonin in people with complete tetraplegia is beneficial , especially for subjective sleep .
-CONCLUSIONS	Investigation of the pharmacokinetics of melatonin metabolism in this population is warranted .
-BACKGROUND	This project is proudly supported by the Transport Accident Commission .
-
-###25926408
-BACKGROUND	Intragastric creaming and droplet size of fat emulsions may affect intragastric behavior and gastrointestinal and satiety responses .
-OBJECTIVE	We tested the hypotheses that gastrointestinal physiologic responses and satiety will be increased by an increase in intragastric stability and by a decrease in fat droplet size of a fat emulsion .
-METHODS	This was a double-blind , randomized crossover study in 11 healthy persons [ 8 men and 3 women , aged 24 1 y ; body mass index ( in kg/m ( 2 ) ) : 24.4 0.9 ] who consumed meals containing 300-g 20 % oil and water emulsion ( 2220 kJ ) with 1 ) larger , 6-m mean droplet size ( Coarse treatment ) expected to cream in the stomach ; 2 ) larger , 6-m mean droplet size with 0.5 % locust bean gum ( LBG ; Coarse + LBG treatment ) to prevent creaming ; or 3 ) smaller , 0.4-m mean droplet size with LBG ( Fine + LBG treatment ) .
-METHODS	The participants were imaged hourly by using MRI and food intake was assessed by using a meal that participants consumed ad libitum .
-RESULTS	The Coarse + LBG treatment ( preventing creaming in the stomach ) slowed gastric emptying , resulting in 12 % higher gastric volume over time ( P < 0.001 ) , increased small bowel water content ( SBWC ) by 11 % ( P < 0.01 ) , slowed appearance of the ( 13 ) C label in the breath by 17 % ( P < 0.01 ) , and reduced food intake by 9 % ( P < 0.05 ) compared with the Coarse treatment .
-RESULTS	The Fine + LBG treatment ( smaller droplet size ) slowed gastric emptying , resulting in 18 % higher gastric volume ( P < 0.001 ) , increased SBWC content by 15 % ( P < 0.01 ) , and significantly reduced food intake by 11 % ( P < 0.05 , equivalent to an average of 411 kJ less energy consumed ) compared with the Coarse + LBG treatment .
-RESULTS	These high-fat meals stimulated substantial increases in SBWC , which increased to a peak at 4 h at 568 mL ( range : 150-854 mL ; P < 0.01 ) for the Fine + LBG treatment .
-CONCLUSIONS	Manipulating intragastric stability and fat emulsion droplet size can influence human gastrointestinal physiology and food intake .
-
-###24622120
-OBJECTIVE	This analysis aimed to perform a head-to-head comparison of 3 of the promising biomarkers of cardiovascular ( CV ) outcomes in heart failure ( HF ) - soluble ST2 ( sST2 ) , growth differentiation factor ( GDF ) -15 , and highly-sensitive troponin T ( hsTnT ) - and to evaluate the role of serial measurement of these biomarkers in patients with chronic HF .
-BACKGROUND	sST2 , GDF-15 , and hsTnT are strongly associated with CV outcomes in HF .
-METHODS	This post-hoc analysis used data from a study in which 151 patients with chronic HF due to left ventricular systolic dysfunction were followed up over 10 months .
-METHODS	At each visit , N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) , sST2 , GDF-15 , and hsTnT were measured and any major CV events were recorded .
-RESULTS	Baseline values of all 3 novel biomarkers independently predicted total CV events even after adjusting for clinical and biochemical characteristics , including NT-proBNP , with the best model including all 3 biomarkers ( p < 0.001 ) .
-RESULTS	Adding serial measurement to the base model appeared to improve the model 's predictive ability ( with sST2 showing the most promise ) , but it is not clear whether this addition is a unique contribution .
-RESULTS	However , when time-dependent factors were included , only sST2 serial measurement independently added to the risk model ( odds ratio : 3.64 ; 95 % confidence interval : 1.37 to 9.67 ; p = 0.009 ) and predicted reverse myocardial remodeling ( odds ratio : 1.22 ; 95 % confidence interval : 1.04 to 1.43 ; p = 0.01 ) .
-CONCLUSIONS	In patients with chronic HF , baseline measurement of novel biomarkers added independent prognostic information to clinical variables and NT-proBNP .
-CONCLUSIONS	Only serial measurement of sST2 appeared to add prognostic information to baseline concentrations and predicted change in left ventricular function .
-CONCLUSIONS	( Use of NT-proBNP Testing to Guide Heart Failure Therapy in the Outpatient Setting ( PROTECT ) ] ; NCT00351390 ) .
-
-###24291054
-BACKGROUND	Diabetes mellitus is associated with oxidative stress which impairs the platelet function .
-BACKGROUND	Phyllanthus emblica extract a rich source of vitamin C plays an important role in scavenging free radicals .
-BACKGROUND	The effect of vitamin C on platelet aggregation in healthy and coronary artery disease patients has been demonstrated .
-BACKGROUND	The present study attempts to study the pharmacodynamic interactions of P. emblica extract with clopidogrel and ecosprin .
-METHODS	This was a randomized open label crossover study of 10 type II diabetic patients .
-METHODS	The dosage schedules were either single dose of 500 mg P. emblica extract or 75 mg clopidogrel or 75 mg ecosprin or 500 mg P. emblica +75 mg clopidogrel or 500 mg P. emblica +75 mg ecosprin .
-METHODS	After single dose study and washout period , patients received either 500 mg P. emblica extract twice daily or 75 mg clopidogrel or 75 mg ecosprin once daily or combinations for 10 days .
-METHODS	Platelet aggregation was measured at baseline and at 4h of treatment after single and multiple dose study along with recording of bleeding and clotting time .
-RESULTS	After single and multiple dose administration of the three treatments and with combinations there was statistically significant decrease of platelet aggregation compared to baseline .
-RESULTS	Further , the mean percent inhibition of platelet aggregation was significant , when compared between single and multiple doses of P. emblica .
-RESULTS	The bleeding and clotting time was prolonged with single and multiple dose administration of all treatments compared to baseline .
-RESULTS	All treatments were well tolerated .
-CONCLUSIONS	P. emblica extract demonstrated significant antiplatelet activity with both single and multiple dose administration .
-
-###24825805
-OBJECTIVE	To compare the efficacy and safety of intramuscular meperidine injection with periprostatic nerve block ( PNB ) during transrectal ultrasound-guided prostate biopsy .
-METHODS	This study was carried out from July 2010 to June 2012 at the First Affiliated Hospital of Fujian Medical University , Fuzhou , Fujian , China .
-METHODS	This controlled , double-blinded , randomized study included 186 patients .
-METHODS	These patients were randomly assigned to 3 treatment groups : PNB by injection 10 minutes prior to the prostate biopsy ; intramuscular meperidine injection administered 30 minutes before the biopsy , and a control group ( n = 62 , each ) .
-METHODS	At the time of ultrasound probe insertion , during biopsy , and 30 minutes after biopsy , patients graded their level of pain on a 10-point visual analog scale ( VAS ) .
-RESULTS	There was no statistical difference in clinical features of the 3 groups .
-RESULTS	The patients administered meperidine had the minimum mean VAS score during probe insertion .
-RESULTS	During the prostate biopsy , there was no significant difference in VAS scores between patients in the PNB and meperidine groups , and both were significantly lower than that of the control group .
-RESULTS	The VAS scores recorded 30 minutes after biopsy were similar among the 3 groups .
-CONCLUSIONS	Intramuscular meperidine injection is a safe and effective analgesic for use during transrectal ultrasound-guided prostate biopsy , and provides better analgesia than PNB during the probe insertion .
-
-###24807604
-BACKGROUND	Dyschezia is a defecatory disorder that places a heavy burden on a patient 's quality of life .
-BACKGROUND	Biofeedback is the recommended treatment in most cases .
-OBJECTIVE	The objective of our study was to test whether a CO2-releasing suppository for patients with dyschezia could be effective in improving biofeedback training results .
-METHODS	A randomized , double-blind , multicenter , placebo-controlled study was conducted in patients ( 18-75 years of age ) with dyschezia defined according to the modified Rome III criteria .
-METHODS	Patients were randomly assigned to either a CO2-releasing suppository or placebo suppository once per day for 21 days .
-METHODS	This was a multicenter trial .
-METHODS	A total of 122 patients were randomly assigned ( 62 intervention group and 60 placebo group ) .
-METHODS	The primary end point was the change from day 0 to day 21 in intensity of symptoms on the basis of a self-assessed dyschezia using a visual analog scale ( range , 0-100 ) .
-METHODS	Analyses were performed using intention-to-treat principles .
-RESULTS	A greater reduction from baseline to day 21 in symptom visual analog scale score was observed in the intervention group ( -41.3 mm ) than in the control group ( -22.3 mm ) .
-RESULTS	Some secondary efficacy parameters improved more in the intervention group , including the percentage of patients who improved 50 % , symptom intensity over 21 days , stool stains on underwear or pads , and need to practice manual maneuvers to facilitate defecation at day 21 .
-RESULTS	At day 21 , rectal sensitivity in the intervention group ( 31.4 mL ) was lower than in the control group ( 39.1 mL ) .
-CONCLUSIONS	There was a lower number of patients recruited than planned by the protocol .
-CONCLUSIONS	The sponsor stopped the trial before the inclusion of 306 participants , with no intermediate analysis .
-CONCLUSIONS	In addition , the main analysis conducted on the full analysis set population could have led to a statistical bias .
-CONCLUSIONS	The results of this multicenter trial demonstrate the added benefits of a CO2-releasing suppository in patients with dyschezia who were treated by anorectal biofeedback training .
-
-###25188403
-OBJECTIVE	To investigate the effects of inhaler device technique education on improving inhaler technique in older people with asthma .
-METHODS	In a randomised controlled trial , device technique education was provided to a sample of 123 adults aged > 55 years who had a doctor diagnosis of asthma .
-METHODS	The active education group received one-on-one technique coaching , including observation , verbal instruction and physical demonstration at baseline .
-METHODS	The passive group received a device-specific instruction pamphlet only .
-METHODS	Inhaler technique , including the critical steps for each device type , was assessed and scored according to Australian National Asthma Council ( NAC ) guidelines .
-METHODS	Device technique was scored objectively at baseline and again at 3 and 12 months post education .
-RESULTS	The majority of participants demonstrated poor technique at baseline .
-RESULTS	Only 11 ( 21 % ) of the active intervention group and 7 ( 16 % ) of the passive group demonstrated 100 % correct technique .
-RESULTS	By 3 months 26 ( 48 % ) of the active group achieved adequate technique .
-RESULTS	Improvement in technique was observed in the active group at 3 months ( P < 0.001 ) and remained significant at 12 months ( P < 0.001 ) .
-RESULTS	No statistically significant improvement was observed in the passive group .
-CONCLUSIONS	The provision of active device technique education improves device technique in older adults .
-CONCLUSIONS	Passive education alone fails to achieve any improvement in device technique .
-
-###24906491
-BACKGROUND	We sought to determine whether empirical nesiritide or milrinone would improve the early postoperative course after Fontan surgery .
-BACKGROUND	We hypothesized that compared with milrinone or placebo , patients assigned to receive nesiritide would have improved early postoperative outcomes .
-RESULTS	In a single-center , randomized , double-blinded , placebo-controlled , multi-arm parallel-group clinical trial , patients undergoing primary Fontan surgery were assigned to receive nesiritide , milrinone , or placebo .
-RESULTS	A loading dose of study drug was administered on cardiopulmonary bypass followed by a continuous infusion for 12 hours and 5 days after cardiac intensive care unit admission .
-RESULTS	The primary outcome was days alive and out of the hospital within 30 days of surgery .
-RESULTS	Secondary outcomes included measures of cardiovascular function , renal function , resource use , and adverse events .
-RESULTS	Among 106 enrolled subjects , 35 , 36 , and 35 were randomized to the nesiritide , milrinone , and placebo groups , respectively , and all were analyzed based on intention to treat .
-RESULTS	Demographics , patient characteristics , and operative factors were similar among treatment groups .
-RESULTS	No significant treatment group differences were found for median days alive and out of the hospital within 30 days of surgery ( nesiritide , 20 [ minimum to maximum , 0-24 ] ; milrinone , 18 [ 0-23 ] ; placebo , 20 [ 0-23 ] ; P = 0.38 ) .
-RESULTS	Treatment groups did not significantly differ in cardiac index , arrhythmias , peak lactate , inotropic scores , urine output , duration of mechanical ventilation , intensive care or chest tube drainage , or adverse events .
-CONCLUSIONS	Compared with placebo , empirical perioperative nesiritide or milrinone infusions are not associated with improved early clinical outcomes after Fontan surgery .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00543309 .
-
-###25622666
-OBJECTIVE	To explore the application of optimal monochromatic images according to computed tomography ( CT ) values of conventional CT scans with high concentration contrast agent and the feasibility in guiding abdominal arteries imaging with low concentration contrast .
-METHODS	From March 2013 to February 2014 , 160 patients of suspected celiac disease with a body mass index ( BMI ) of > 25 kg/m ( 2 ) underwent spectral CT scan .
-METHODS	And they were randomly divided into two groups .
-METHODS	In group A ( n = 61 ) , 270 mgI/ml low concentrations of contrast agents and spectral CT imaging ; in group B ( n = 99 ) , 350 mgI/ml high concentrations of contrast agents and 120 kVp scan .
-METHODS	For CT values of the first measurement of abdominal aorta B group of patients , the average CT value was calculated .
-METHODS	The optimal monochromatic images of group A according to CT values of group B were reconstructed and 70 keV images ( group C ) also reconstructed .
-METHODS	The CT values of hepatic , splenic , right renal and superior mesenteric arteries were measured and contrast to noise ratios ( CNRs ) calculated .
-METHODS	CT values and CNR were compared through t test on independent samples .
-METHODS	P > 0.05 indicated no significant difference .
-RESULTS	Mean CT value of abdominal aorta was ( 422 65 ) HU in group B. And optimal keV was ( 67 5 ) keV in group A. CT values of abdominal aorta and its branches showed no statistical significance ; the CNRs of abdominal aorta and its branches showed statistical significance .
-RESULTS	The scoring consistency between two observers was excellent and the score ( 4.1 0.9 vs 4.2 0.7 ) showed no significant difference ( P > 0.05 ) .
-CONCLUSIONS	GSI abdominal scans with low concentration contrast may obtain better image qualities compared to conventional CTA of high concentration .
-CONCLUSIONS	And ( 67 5 ) keV is recommended .
-
-###24256671
-BACKGROUND	Platelet transfusion is increasingly used in patients with traumatic intracranial hemorrhage ( ICH ) on aspirin therapy to minimize the progression of ICH .
-BACKGROUND	We hypothesized ( null ) that platelet transfusion in this cohort of patients does not improve platelet function .
-METHODS	We performed a prospective interventional trail on patients with traumatic ICH on daily high-dose ( 325 mg ) aspirin therapy .
-METHODS	All patients received one pack of apheresis platelets .
-METHODS	Blood samples were collected before and 1 hour after platelet transfusion .
-METHODS	Platelet function was assessed using Verify Now Platelet Function Assay , and a cutoff of greater than 550 aspirin reaction units was used to define functioning platelets ( FP ) .
-RESULTS	Twenty-eight patients were enrolled in the study .
-RESULTS	On presentation , 79 % ( 22 of 28 ) of the patients had nonfunctioning platelets ( NFPs ) , and transfusion of platelets did not improve platelet function as 81 % ( 18 of 22 ) still had NFP .
-RESULTS	Of the 22 patients , 4 converted from NFP to FP after transfusion .
-RESULTS	There was no difference in the progression of ICH ( 37.5 % vs. 30 % , p = 0.7 ) or neurosurgical intervention ( 12.5 % vs. 15 % , p = 0.86 ) between patients with FP and NFP after platelet transfusion .
-CONCLUSIONS	Administration of one pack of apheresis platelet did not improve platelet function .
-CONCLUSIONS	In our study , progression of ICH and the need for neurosurgical intervention were independent of platelet function .
-CONCLUSIONS	Further randomized clinical trials are required to assess both the dose dependence effect and role of platelet transfusion in patients on antiplatelet therapy with traumatic ICH .
-METHODS	Therapeutic study , level III .
-
-###25920649
-OBJECTIVE	To compare the short-term functional outcome after computer-assisted total knee arthroplasty ( TKA ) versus conventional TKA .
-METHODS	23 men and 67 women aged 48 to 80 years were randomised to undergo ( 1 ) conventional TKA using an intramedullary guide , ( 2 ) conventional TKA using an extramedullary guide , or ( 3 ) computer-assisted TKA .
-METHODS	Two senior surgeons performed all the TKAs using the same TKA system and the standard anteromedial arthrotomy with eversion of the patella .
-METHODS	Patients were assessed by physiotherapists before and 6 months and 2 years after TKA using the Short Form-36 Health Survey , Oxford Knee Score , and Knee Society Score .
-RESULTS	Of the 90 patients , 67 and 70 were assessed at 6 months and 2 years after TKA , respectively .
-RESULTS	No patient developed deep infection or required revision surgery .
-RESULTS	Functional outcomes of the 3 groups did not differ significantly at the corresponding follow-ups .
-CONCLUSIONS	Significant improvement in the functional outcome was not shown in patients treated with computer-assisted TKA , compared with conventional TKA .
-CONCLUSIONS	Thus , computer-assisted TKA has limited additional short-term benefits .
-CONCLUSIONS	Further studies with longer follow-up are required to examine the benefits of computer-assisted TKA .
-
-###25336745
-OBJECTIVE	We aim to characterize the effects on total body fat and distribution of a 1-year intensive lifestyle intervention ( ILI ) for weight loss in overweight and obese adults with type 2 diabetes and to examine whether changes in adipose tissue ( AT ) depots were associated with changes in metabolic biomarkers .
-METHODS	Participants were 54 females and 38 males ( age 57.8 6.7 years [ mean SD ] ; BMI 31.7 3.5 kg/m ( 2 ) ) enrolled in the Look AHEAD ( Action for Health in Diabetes ) trial randomized to ILI or diabetes support and education ( DSE ) from whom baseline and 1-year MRI measures of total AT ( TAT ) and regional ( arm , trunk , leg ) AT , including subcutaneous AT ( SAT ) , visceral AT ( VAT ) , and intermuscular AT ( IMAT ) , were acquired .
-METHODS	We tested whether mean changes in ILI and DSE were equal and , within groups , whether changes were different from zero .
-METHODS	Regression models tested whether changes in AT compartments were associated with metabolic variable changes .
-RESULTS	Body weight changed -0.52 3.62 kg ( P = 0.31 ) in DSE and -7.24 5.40 kg ( P < 0.0001 ) in ILI .
-RESULTS	Mean ILI changes were different from DSE ( P < 0.001 for TAT , SAT , and IMAT and P < 0.01 for VAT in females ) .
-RESULTS	Within ILI , SAT and VAT decreased in males and females ( P < 0.0001 ) , but IMAT was unchanged ( 0.00 0.54 kg ; P = 0.99 ) .
-RESULTS	In DSE , SAT and VAT did not change , but IMAT increased by 0.46 0.55 kg ( P < 0.001 ) .
-RESULTS	Controlling for weight loss , reduction of specific AT depots was associated with improvement in metabolic biomarkers .
-CONCLUSIONS	Weight loss of 7-10 % from an ILI over 1 year reduced SAT and VAT and prevented an increase in IMAT .
-CONCLUSIONS	Reductions in AT depots were associated with improvements in biomarkers .
-
-###24442048
-OBJECTIVE	Psoriasis is a systemic inflammatory immune-mediated skin disease .
-OBJECTIVE	Recently a relationship with metabolic syndrome in terms of psoriasis severity and response to therapy was observed .
-METHODS	We performed an open-label randomized controlled study to evaluate the role of a nutraceutical containing Q10 coenzyme , Krill-oil , lipoic acid , resveratrol , Vitis vinifera seed oil , vitamin E and selenium in addition to etanercept therapy for patients affected by psoriasis and metabolic syndrome .
-METHODS	Forty patients were enrolled and divided into two arms , one receiving only etanercept , one other receiving also the neutraceutical .
-METHODS	After a period of 3 months ( T1 ) a second evaluation of the considered parameters was performed .
-RESULTS	At T1 statistically significant differences were detected in HDL cholesterol and triglycerides values both comparing the two arms and in the nutraceutical arm .
-CONCLUSIONS	Our results show that the dietary addiction of the nutraceutical to the etanercept therapy in patients affected by both psoriasis and metabolic syndrome could help to restore the normal lipid profile .
-
-###24334216
-BACKGROUND	Sexual health problems such as unwanted pregnancy and sexually transmitted infection are important public health concerns and there is huge potential for health promotion using digital interventions .
-BACKGROUND	Evaluations of digital interventions are increasingly conducted online .
-BACKGROUND	Trial administration and data collection online offers many advantages , but concerns remain over fraudulent registration to obtain compensation , the quality of self-reported data , and high attrition .
-OBJECTIVE	This study addresses the feasibility of several dimensions of online trial design-recruitment , online consent , participant identity verification , randomization and concealment of allocation , online data collection , data quality , and retention at 3-month follow-up .
-METHODS	Young people aged 16 to 20 years and resident in the United Kingdom were recruited to the `` Sexunzipped '' online trial between November 2010 and March 2011 ( n = 2036 ) .
-METHODS	Participants filled in baseline demographic and sexual health questionnaires online and were randomized to the Sexunzipped interactive intervention website or to an information-only control website .
-METHODS	Participants were also randomly allocated to a postal request ( or no request ) for a urine sample for genital chlamydia testing and receipt of a lower ( 10/US $ 16 ) or higher ( 20/US $ 32 ) value shopping voucher compensation for 3-month outcome data .
-RESULTS	The majority of the 2006 valid participants ( 90.98 % , 1825/2006 ) were aged between 18 and 20 years at enrolment , from all four countries in the United Kingdom .
-RESULTS	Most were white ( 89.98 % , 1805/2006 ) , most were in school or training ( 77.48 % , 1545/1994 ) , and 62.81 % ( 1260/2006 ) of the sample were female .
-RESULTS	In total , 3.88 % ( 79/2036 ) of registrations appeared to be invalid and another 4.00 % ( 81/2006 ) of participants gave inconsistent responses within the questionnaire .
-RESULTS	The higher value compensation ( 20/US $ 32 ) increased response rates by 6-10 % , boosting retention at 3 months to 77.2 % ( 166/215 ) for submission of online self-reported sexual health outcomes and 47.4 % ( 118/249 ) for return of chlamydia urine samples by post .
-CONCLUSIONS	It was quick and efficient to recruit young people to this online trial .
-CONCLUSIONS	Our procedures for obtaining online consent , verifying participant identity , automated randomization , and concealment of allocation worked well .
-CONCLUSIONS	The optimal response rate for the online sexual health outcome measurement was comparable to face-to-face trials .
-CONCLUSIONS	Multiple methods of participant contact , requesting online data only , and higher value compensation increased trial retention at 3-month follow-up .
-BACKGROUND	International Standard Randomized Controlled Trial Number ( ISRCTN ) : 55651027 ; http://www.controlled-trials.com/ISRCTN55651027 ( Archived by WebCite at http://www.webcitation.org/6LbkxdPKf ) .
-
-###24534413
-OBJECTIVE	We conducted a randomized trial to test the hypothesis that mother 's voice played through a pacifier-activated music player ( PAM ) during nonnutritive sucking would improve the development of sucking ability and promote more effective oral feeding in preterm infants .
-METHODS	Preterm infants between 34 0/7 and 35 6/7 weeks ' postmenstrual age , including those with brain injury , who were taking at least half their feedings enterally and less than half orally , were randomly assigned to receive 5 daily 15-minute sessions of either PAM with mother 's recorded voice or no PAM , along with routine nonnutritive sucking and maternal care in both groups .
-METHODS	Assignment was masked to the clinical team .
-RESULTS	Ninety-four infants ( 46 and 48 in the PAM intervention and control groups , respectively ) completed the study .
-RESULTS	The intervention group had significantly increased oral feeding rate ( 2.0 vs. 0.9 mL/min , P < .001 ) , oral volume intake ( 91.1 vs. 48.1 mL/kg/d , P = .001 ) , oral feeds/day ( 6.5 vs. 4.0 , P < .001 ) , and faster time-to-full oral feedings ( 31 vs. 38 d , P = .04 ) compared with controls .
-RESULTS	Weight gain and cortisol levels during the 5-day protocol were not different between groups .
-RESULTS	Average hospital stays were 20 % shorter in the PAM group , but the difference was not significant ( P = .07 ) .
-CONCLUSIONS	A PAM using mother 's voice improves oral feeding skills in preterm infants without adverse effects on hormonal stress or growth .
-
-###26258311
-OBJECTIVE	To determine the safety and efficacy of cryopreserved packed red blood cell ( CPRBC ) transfusion in trauma patients .
-BACKGROUND	Liquid packed red blood cells ( LPRBCs ) have an abbreviated shelf-life and worsening storage lesion with age .
-BACKGROUND	CPRBCs are frozen 2 to 6 days after donation , stored up to 10 years , and are available for 14 days after thawing and washing .
-BACKGROUND	CPRBCs can be utilized in diverse settings , but the effect on clinical outcomes is unknown .
-METHODS	We performed a prospective , randomized , double-blind study at 5 level 1 trauma centers .
-METHODS	Stable trauma patients requiring transfusion were randomized to young LPRBCs ( 14 storage days ) , old LPRBCs ( > 14 storage days ) , or CPRBCs .
-METHODS	Tissue oxygenation ( StO2 ) , biochemical and inflammatory mediators were measured , and clinical outcomes were determined .
-RESULTS	Two hundred fifty-six patients with well-matched injury severity and demographics ( P > 0.2 ) were randomized ( 84 young , 86 old , and 86 CPRBCs ) .
-RESULTS	Pretransfusion and final hematocrits were similar ( P > 0.68 ) .
-RESULTS	Patients in all groups received the same number of units postrandomization ( 2 [ 1-4 ] ; P > 0.05 ) .
-RESULTS	There was no difference in the change in tissue oxygenation between groups .
-RESULTS	CPRBCs contained less 2-macrogobulin , haptoglobin , C-reactive protein , and serum amyloid P ( P < 0.001 ) .
-RESULTS	Organ failure , infection rate , and mortality did not differ between groups ( P > 0.2 ) .
-CONCLUSIONS	Transfusion of CPRBCs is as safe and effective as transfusion of young and old LPRBCs and provides a mechanism to deliver PRBCs in a wide variety of settings .
-
-###25394474
-BACKGROUND	Halitosis is a common problem that affects a large portion of the population worldwide .
-BACKGROUND	The origin of this condition is oral in 90 % and systemic in 10 % of cases .
-BACKGROUND	The unpleasant odor is mainly the result of volatile sulfur compounds produced by Gram-negative bacteria .
-BACKGROUND	However , it has recently been found that anaerobic Gram-positive bacteria also produce hydrogen sulfide ( H2S ) in the presence of amino acids , such as cysteine .
-BACKGROUND	Light , both with and without the use of chemical agents , has been used to induce therapeutic and antimicrobial effects .
-BACKGROUND	In photodynamic therapy , the antimicrobial effect is confined to areas covered by photosensitizing dye .
-BACKGROUND	The aim of the present study is to evaluate the antimicrobial effect of photodynamic therapy on halitosis in adolescents through the analysis of volatile sulfur compounds measured using gas chromatography and microbiological analysis of coated tongue .
-METHODS	A quantitative clinical trial will be carried out involving 60 adolescents randomly divided into the following groups : group 1 will receive treatment with a tongue scraper , group 2 will receive photodynamic therapy applied to the posterior two-thirds of the dorsum of the tongue , and group 3 will receive combined treatment ( tongue scraper and photodynamic therapy ) .
-METHODS	Gas chromatography ( OralChromaTM ) and microbiological analysis will be used for the diagnosis of halitosis at the beginning of the study .
-METHODS	Post-treatment evaluations will be conducted at one hour and 24hours after treatment .
-METHODS	The statistical analysis will include the Shapiro-Wilk test for the determination of the distribution of the data .
-METHODS	If normal distribution is demonstrated , analysis of variance followed by Tukey 's test will be used to compare groups .
-METHODS	The Kruskal-Wallis test followed by the Student-Newman-Keuls test will be used for data with non-normal distribution .
-METHODS	Either the paired t-test or the Wilcoxon test will be used to compare data before and after treatment , depending on the distribution of the data .
-CONCLUSIONS	The results of this trial will determine the efficacy of using photodynamic therapy alone or in combination with a tongue scraper to treat bad breath in adolescents .
-BACKGROUND	The protocol for this study was registered with Clinical Trials ( registration number NCT02007993 ) on 10 December 2013 .
-
-###25400471
-OBJECTIVE	To compare efficacy , patient compliance , acceptability , satisfaction , safety , and adenoma detection rate of sodium phosphate tablets ( NaP , CLICOLON ( TM ) ) to a standard 4 L polyethylene glycol ( PEG ) solution for bowel cleansing for adults undergoing colonoscopy .
-METHODS	In this multicenter , randomized , prospective , investigator-blind study , the relatively young ( 19-60 years ) healthy outpatients without comorbidity were randomly assigned to one of two arms .
-METHODS	All colonoscopy were scheduled in the morning .
-METHODS	The NaP group was asked to take 4 tablets , 5 times the evening before and 4 tablets , 3 times early on the morning of the colonoscopy .
-METHODS	The PEG group was asked to ingest 2 L of solution the evening before and 2 L early in the morning of the procedure .
-METHODS	Adequacy of bowel preparation was scored using the Boston bowel preparation scale .
-RESULTS	No significant differences were observed between the NaP group ( n = 158 ) and PEG group ( n = 162 ) in bowel cleansing quality ( adequate preparation 93.0 % vs 92.6 % , P = 0.877 ) , patient compliance ( P = 0.228 ) , overall adverse events ( 63.3 % vs 69.1 % , P = 0.269 ) , or adenoma detection rate ( 34.8 % vs 35.2 % , P = 0.944 ) .
-RESULTS	Patient acceptability , satisfaction , and patient rating of taste were higher in the NaP group than in the PEG group ( P < 0.001 ) .
-CONCLUSIONS	NaP tablets , compared with PEG solution , produced equivalent colon cleansing , did not cause more side effects , and had better patient acceptability and satisfaction in the relatively young ( age < 60 years ) healthy individuals without comorbidity .
-CONCLUSIONS	An oral tablet formulation could make bowel preparation less burdensome , resulting in greater patient participation in screening programs .
-
-###24524414
-OBJECTIVE	This study compared the performance of two new bone-anchored hearing aids with older bone-anchored hearing aids that were not fully digital .
-METHODS	Fourteen experienced bone-anchored hearing aid users participated in this cross-over study .
-METHODS	Performance of their existing bone-anchored hearing aid was assessed using speech-in-noise testing and questionnaires .
-METHODS	Participants were then fitted with either a Ponto Pro or a BP100 device .
-METHODS	After four weeks of use with each new device , the same assessments were repeated .
-RESULTS	Speech-in-noise testing for the 50 per cent signal-to-noise ratio ( the ratio at which 50 per cent of responses were correct ) showed no significant differences between the Ponto Pro and the BP100 devices ( p = 0.1 ) However , both devices showed significant improvement compared with the participants ' previous bone-anchored hearing aid devices ( p < 0.001 ) .
-RESULTS	There were no significant differences between the two new devices in the questionnaire data .
-CONCLUSIONS	Both fully digital bone-anchored hearing aids demonstrated superior speech processing compared with the previous generation of devices .
-CONCLUSIONS	There were no substantial differences between the two digital devices in either objective or subjective tests .
-
-###24980134
-BACKGROUND	Managing cardiovascular risk factors is important for reducing vascular complications in type 2 diabetes , even in individuals who have achieved glycemic control .
-BACKGROUND	Nut consumption is associated with reduced cardiovascular risk ; however , there is mixed evidence about the effect of nuts on blood pressure ( BP ) , and limited research on the underlying hemodynamics .
-BACKGROUND	This study assessed the effect of pistachio consumption on BP , systemic hemodynamics , and heart rate variability in adults with well-controlled type 2 diabetes .
-RESULTS	We enrolled 30 adults ( 40 to 74 years ) with type 2 diabetes in a randomized , crossover , controlled feeding study .
-RESULTS	After a 2-week run-in period , participants consumed a low-fat control diet ( 27 % fat ) containing low-fat/high-carbohydrate snacks and a moderate-fat diet ( 33 % fat ) containing pistachios ( 20 % of total energy ) for 4 weeks each , separated by a 2-week washout .
-RESULTS	Following each diet period , we assessed BP , systemic hemodynamics , and heart rate variability at rest and during acute mental stress , and , in a subset of participants ( n = 21 ) , 24-hour ambulatory BP .
-RESULTS	BP at rest and during stress did not differ between treatments .
-RESULTS	The pistachio diet significantly reduced total peripheral resistance ( -3.72.9 % , P = 0.004 ) , increased cardiac output ( 3.12.3 % , P = 0.002 ) , and improved some measures of heart rate variability ( all P < 0.05 ) .
-RESULTS	Systolic ambulatory BP was significantly reduced by 3.52.2 mm Hg ( P = 0.046 ) following the pistachio diet , with the greatest reduction observed during sleep ( -5.72.6 mm Hg , P = 0.052 ) .
-CONCLUSIONS	A moderate-fat diet containing pistachios modestly improves some cardiovascular risk factors in adults with well-controlled type 2 diabetes .
-BACKGROUND	www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00956735 .
-
-###24488742
-OBJECTIVE	To determine how symmetric ( proportionate ; SGR ) and asymmetric ( disproportionate ; AGR ) growth restriction influence growth and development in preterms from birth to 4 years .
-METHODS	This community-based cohort study of 810 children comprised 86 SGR , 61 AGR , and 663 non-growth restricted ( NGR ) preterms , born in 2002 and 2003 .
-METHODS	Symmetrical growth restriction was defined as a birth weight below the 16th percentile ( -1 SD ) compared with full-terms and a head circumference ( HC ) z score not exceeding the infant 's birth weight z score by > 1 SD .
-METHODS	Asymmetric growth restriction was defined as a HC z score exceeding that for by > 1 SD as a proxy of brain sparing .
-METHODS	Developmental delay was assessed by the Ages and Stages Questionnaire at 4 years .
-RESULTS	Longitudinal gains in weight and height were similar for SGR and AGR children and less compared with NGR children .
-RESULTS	At age 4 , z scores for weight were -1.1 for SGR and -0.7 for AGR children vs -0.3 for NGR children .
-RESULTS	z scores for height were -0.8 and -0.5 vs. -0.2 .
-RESULTS	HC gain were 2 cm more in SGR , but at 1 year , they were -0.2 vs. 0.2 ( AGR ) and 0.1 ( NGR ) .
-RESULTS	Developmental delay increased with odds ratios of 2.5 ( 95 % confidence interval 1.1-6 .0 ) for SGR and 2.1 ( 95 % confidence interval 0.7-5 .9 ) for AGR .
-CONCLUSIONS	Weight and height gains were similar for AGR and SGR children but poorer compared with NGR children .
-CONCLUSIONS	SGR children caught up on HC .
-CONCLUSIONS	Developmental delay was more likely in growth-restricted preterms independent of HC at birth .
-
-###24655411
-BACKGROUND	Recent studies have assessed the therapeutic potential and drawbacks of mesenchymal stem cells ( MSCs ) .
-BACKGROUND	The adverse reactions of intravenous transplantation of bone marrow ( BM ) - derived MSCs were examined at varying doses and frequencies of administration .
-BACKGROUND	Nine healthy beagle dogs were purchased from a commercial laboratory .
-BACKGROUND	The dogs were distributed equally ( n = 3 per group ) and randomly into three groups .
-BACKGROUND	All dogs received allogeneic BM-derived MSCs : 210 once ( group A ) , 210 once ( group B ) , and 210 for three consecutive days ( group C ) .
-BACKGROUND	Various laboratory examinations , multi-detector computed tomography features and histopathology were evaluated to clarify the clinical and diagnostic features of adverse reactions of MSCs administration , prior to receiving MSCs ( pre procedure ) and on days 1 , 3 , and 7 post transplantation .
-RESULTS	Only one dog had clinical signs during and after MSCs transplantation .
-RESULTS	Dogs receiving 210 MSCs showed increased numbers of lymphocytes but the total white blood cell counts were not elevated ( P < 0.01 ) .
-RESULTS	Multi-detector computed tomography ( MDCT ) revealed pulmonary parenchymal changes in one dog and histopathologic examination revealed pulmonary parenchymal edema and hemorrhage in four dogs .
-RESULTS	The presence of pulmonary thromboembolism was not detected in either examination .
-CONCLUSIONS	We considered the presence of pulmonary edema and hemorrhage as possible adverse reactions after intravenous MSCs transplantation ; however these results should be cautiously interpreted .
-
-###24338959
-BACKGROUND	Comparison of state-designated primary and comprehensive stroke centers ( PSCs and CSCs ) with regard to adherence to nationally accepted performance standards are scarce .
-BACKGROUND	The objective of this study was to examine if a significant association exists between level of designation and fulfillment of Joint Commission ( JC ) stroke core measures .
-METHODS	A retrospective comparative data analysis of the New Jersey acute stroke registry for the calendar years 2010 and 2011 was performed .
-METHODS	JC core measures were compared by hospital level ( PSCs vs CSCs ) .
-METHODS	Adjusted odds ratios ( aOR ) were estimated for association between hospital levels and fulfillment of JC core measures .
-METHODS	Median door-to-thrombolytic time was also compared .
-RESULTS	There were 36,892 acute stroke admissions .
-RESULTS	PSCs had 60 % of the patients , whereas CSCs had 40 % .
-RESULTS	Hemorrhagic stroke admissions were about 2 times more frequent at CSCs than PSCs ( 13.3 % and 7.1 % , respectively ) .
-RESULTS	CSCs adhered better to 6 of the 8 JC measures than PSCs .
-RESULTS	Of eligible patients , 19.5 % received thrombolytic therapy at CSCs compared to 9.6 % at PSCs , with a 44 % difference in provision of thrombolytic therapy ( aOR = 0.28 , 95 % confidence interval : 0.24-0 .34 ) .
-RESULTS	Median door-to-thrombolytic drug times was 65 minutes at CSCs compared to 74.0 minutes at PSCs ( P < 0.0001 ) .
-CONCLUSIONS	New Jersey state-designated CSCs are better at adhering to the JC core stroke measures and have shorter door-to-thrombolytic drug times .
-
-###25262257
-BACKGROUND	The prevalence and correlates of dual-antiplatelet therapy ( DAPT ) use in stable coronary artery disease ( CAD ) are unknown .
-BACKGROUND	In addition , whether prolonged DAPT may impact prognosis in stable CAD has not been studied in real-life conditions .
-METHODS	We studied 3,691 patients included in a prospective registry on stable CAD .
-METHODS	The patients were divided in 2 groups according to their antiplatelet therapy regimen at inclusion : patients treated with DAPT were compared with those treated with single-antiplatelet therapy ( SAPT ) .
-METHODS	The primary outcome was a composite of cardiovascular death , myocardial infarction , or stroke .
-RESULTS	Altogether , 868 ( 24 % ) patients received DAPT .
-RESULTS	Factors positively associated with DAPT use were persistent angina at inclusion , body mass index , myocardial infarction since 1 to 3 years , myocardial revascularization since 1 to 3 years , multivessel CAD , prior drug-eluting stent implantation , and prior aortic or peripheral intervention .
-RESULTS	Factors negatively associated with DAPT use were age , prior coronary bypass , and left ventricular ejection fraction .
-RESULTS	The rate of the primary outcome at 2 years was similar whether patients were treated with SAPT ( 4.6 % ) or DAPT ( 5.5 % ) ( P = .301 ) .
-RESULTS	Similar rates were also observed after propensity score matching : 5.7 % when treated with SAPT versus 5.5 % when treated with DAPT ( P = .886 ) .
-RESULTS	The rate of bleeding was similar between groups .
-CONCLUSIONS	Our study shows that a significant proportion of stable CAD patients are treated with DAPT in modern practice .
-CONCLUSIONS	Several correlates of DAPT were identified .
-CONCLUSIONS	Although no increase in bleeding was observed , our results do not support the prescription of prolonged DAPT .
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-BACKGROUND	The objective of this study was to assess the efficacy and safety of alfuzosin 10 mg monotherapy or combined antihypertensive medication on blood pressure ( BP ) in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( BPH/LUTS ) with or without antihypertensive medication .
-METHODS	This was a 3-month , multicenter , randomized , open-label study in 335 patients aged 45 years with a clinical diagnosis of BPH/LUTS by medical history and clinical examination , a total International Prostatic Symptom Score ( IPSS ) 8 points , a maximum flow rate > 5 mL/sec and 15 mL/sec , and a voided volume 120 mL .
-METHODS	Eligible subjects were randomized to receive alfuzosin 10 mg as monotherapy ( group 1 ) or alfuzosin 10 mg + antihypertensive combination therapy ( group 2 ) .
-METHODS	Based on baseline BP and hypertensive history with or without antihypertensive medications at first medical examination , group 1 was divided into two subgroups of normotensive and untreated hypertensive patients , and group 2 into two subgroups of controlled hypertensive and uncontrolled hypertensive patients .
-METHODS	The primary study outcomes were change in IPSS , BP , and heart rate from baseline .
-METHODS	Secondary outcomes were change in IPSS-quality of life score , maximum flow rate , average flow rate , voided volume , and post-voided volume .
-RESULTS	The overall BP change was not significantly different between groups 1 and 2 ( systolic BP , P = 0.825 ; diastolic BP , P > 0.999 ) .
-RESULTS	In patients with uncontrolled or untreated hypertension , alfuzosin 10 mg alone or combined with antihypertensive therapy significantly decreased systolic and diastolic BP .
-RESULTS	The mean difference in total IPSS and IPSS-quality of life scores from baseline between groups 1 and 2 was 0.45 ( 95 % CI : -1.26 , 2.16 ) and 0.12 ( 95 % CI : -0.21 , 0.45 ) , respectively ( both P > 0.05 ) .
-RESULTS	Maximum flow rate , average flow rate , voided volume , and post-voided volume at endpoint were numerically , but not significantly , changed from baseline ( all P > 0.05 ) .
-CONCLUSIONS	This study shows that alfuzosin 10 mg is effective and well tolerated in patients with BPH/LUTS with or without antihypertensive medications .
-CONCLUSIONS	However , in patients with uncontrolled or untreated hypertension , alfuzosin 10 mg alone or in combination with antihypertensive medication appears to decrease systolic and diastolic BP , and these patients should be warned about a decrease in BP on initiation of therapy .
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-BACKGROUND	In this phase 3 trial we evaluated the efficacy and safety of the interferon-free combination of ABT-450 with ritonavir ( ABT-450 / r ) , ombitasvir ( also known as ABT-267 ) , dasabuvir ( also known as ABT-333 ) , and ribavirin for the retreatment of HCV in patients who were previously treated with peginterferon-ribavirin .
-METHODS	We enrolled patients with HCV genotype 1 infection and no cirrhosis who had previously been treated with peginterferon-ribavirin and had a relapse , a partial response , or a null response .
-METHODS	Patients were randomly assigned in a 3:1 ratio to receive coformulated ABT-450 / r-ombitasvir ( at a once-daily dose of 150 mg of ABT-450 , 100 mg of ritonavir , and 25 mg of ombitasvir ) and dasabuvir ( 250 mg twice daily ) with ribavirin ( 1000 or 1200 mg daily ) or matching placebos during the 12-week double-blind period .
-METHODS	The primary end point was the rate of sustained virologic response 12 weeks after the end of study treatment .
-METHODS	The primary efficacy analysis compared this rate among patients assigned to the active regimen with a historical response rate ( 65 % ) among previously treated patients with HCV genotype 1 infection and no cirrhosis who had received retreatment with telaprevir and peginterferon-ribavirin .
-RESULTS	A total of 394 patients received at least one study-drug dose .
-RESULTS	In the active-regimen group , 286 of 297 patients had a sustained virologic response at post-treatment week 12 , for an overall rate of 96.3 % ( 95 % confidence interval , 94.2 to 98.4 ) .
-RESULTS	This rate was noninferior and superior to the historical control rate .
-RESULTS	Rates were 95.3 % among patients with a prior relapse ( 82 of 86 patients ) , 100 % among patients with a prior partial response ( 65 of 65 patients ) , and 95.2 % among patients with a prior null response ( 139 of 146 patients ) .
-RESULTS	Pruritus occurred more frequently with the active regimen ( in 13.8 % of patients ) than with placebo ( 5.2 % , P = 0.03 ) .
-RESULTS	Three patients in the active-regimen group ( 1.0 % ) discontinued the study drugs owing to adverse events .
-RESULTS	Hemoglobin values of grade 2 ( 8.0 to < 10.0 g per deciliter ) and grade 3 ( 6.5 to < 8.0 g per deciliter ) occurred in 4.7 % and 0.3 % of patients in the active-regimen group , respectively .
-CONCLUSIONS	Rates of response to a 12-week interferon-free combination regimen were more than 95 % among previously treated patients with HCV genotype 1 infection , including patients with a prior null response .
-CONCLUSIONS	( Funded by AbbVie ; SAPPHIRE-II ClinicalTrials.gov number , NCT01715415 . )
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