Completing family activities during the first year of the program predicted delayed sexual debut for boys .


Theory-based , developmentally appropriate , comprehensive sex education programs that include parent involvement can be effective in delaying vaginal sex for middle school students .


Parent involvement is particularly important for boys , as family activities may encourage parents to talk with their sons earlier and more frequently .


Acupuncture is commonly used to reduce pain during labour despite contradictory results .


The aim of this study is to evaluate the effectiveness of acupuncture with manual stimulation and acupuncture with combined manual and electrical stimulation ( electro-acupuncture ) compared with standard care in reducing labour pain .


Our hypothesis was that both acupuncture stimulation techniques were more effective than standard care , and that electro-acupuncture was most effective .


A longitudinal randomised controlled trial .


The recruitment of participants took place at the admission to the labour ward between November 2008 and October 2011 at two Swedish hospitals .


303 nulliparous women with normal pregnancies were randomised to : 40minutes of manual acupuncture ( MA ) , electro-acupuncture ( EA ) , or standard care without acupuncture ( SC ) .


labour pain , assessed by Visual Analogue Scale ( VAS ) .


relaxation , use of obstetric pain relief during labour and post-partum assessments of labour pain .


The sample size calculation was based on the primary outcome and a difference of 15mm on VAS was regarded as clinically relevant , this gave 101 in each group , including a total of 303 women .


Mean estimated pain scores on VAS ( SC : 69.0 , MA : 66.4 and EA : 68.5 ) , adjusted for : treatment , age , education , and time from baseline , with no interactions did not differ between the groups ( SC vs MA : mean difference 2.6 , 95 % confidence interval [ CI ] -1.7 -6.9 and SC vs EA : mean difference 0.6 [ 95 % CI ] -3.6 -4.8 ) .


Fewer number of women in the EA group used epidural analgesia ( 46 % ) than women in the MA group ( 61 % ) and SC group ( 70 % ) ( EA vs SC : odds ratio [ OR ] 0.35 ; [ 95 % CI ] 0.19-0 .67 ) .


Acupuncture does not reduce women 's experience of labour pain , neither with manual stimulation nor with combined manual and electrical stimulation .


However , fewer women in the EA group used epidural analgesia thus indicating that the effect of acupuncture with electrical stimulation may be underestimated .


These findings were obtained in a context with free access to other forms of pain relief .


ClinicalTrials.gov : NCT01197950 .


To compare-the adequacy of endometrium and the post-procedural pain between the manual vacuum aspiration ( MVA ) and metal curettage method .


The present research was a clinical experiment .


A randomized controlled trial study was done with older than 35-year oldfemales with abnormal intrauterine bleeding who attended the out-patient gynecology department of Maharat Nakhon Ratchasima Hospital between December 1 , 2013 and April 30 , 2014 .


Patients were allocated with simple randomization technique into two groups , the experimental group was using MVA and the control group was using conventional metal uterine curettage .


Pain levels were assessed according to the visual analogue scale .


All tissue samples were examined by pathologists .


Statistics used were percentage and Chi-square .


Percentages of tissue adequacy for pathological examination of control and experiment groups were 87.88 and 90.91 , respectively .


There was no significant difference between the two methods ( p-value = 0.572 ) .


The patients with severe pain in the experiment group were less than that of the control group .


The relative risk is 0.47 ( 95 % CI = 0.30-0 .72 ) .


MVA caused less pain than the metal curette method , while both provided the same rate of adequacy of endometrial tissue sampling for pathological diagnosis .


The MVA offered more humanized health care for gynecological patients who required such procedure .


Further researches focusing on the cost-effectiveness or medical complications could benefit a practice guideline and the health care system for this patient group .


Exposure to acute ` stressors ' ( e.g. infections , pain , trauma ) often results in altered sleep habits and reductions in routine activity .


In some individuals , these behavioural responses to acute stressors may contribute to the development of chronic somatic symptoms such as widespread pain , fatigue , memory difficulties and mood disturbances , much like those associated with ` functional somatic syndromes ' ( FSS ) such as fibromyalgia or chronic fatigue syndrome .


Eighty-seven healthy young adults who reported sleeping between 7 and 9 hours nightly and exercising regularly were randomised to one of four groups : exercise cessation , sleep restriction ( 6 hours nightly ) , both , or neither .


Symptoms of pain , fatigue , cognitive dysfunction and negative mood were measured before and after the 10-day restriction period .


Sleep restriction was a potent contributor to the development of somatic symptoms .


Exercise cessation was less influential leading only to fatigue .


There were no significant interactions between exercise cessation and sleep restriction , except that males were much more likely to develop somatic symptoms when deprived of both sleep and exercise than one or the other .


Women were generally much more likely to develop somatic symptoms than men .


This study supports previous research suggesting that both sleep and exercise are critical in ` preventing ' somatic symptoms among some individuals .


Furthermore , to our knowledge , this is the first time there is data to suggest that women are much more sensitive to decrements in routine sleep and exercise than are men .


Abused women , who suffer from chronic psychological stress , have been shown to have shorter telomeres than never abused women .


Telomere shortening is associated with increased risk of cell death , and it is believed that adopting health-promoting behaviors can help to increase the activity of telomerase , an enzyme that counters telomere shortening .


Qigong is an ancient Chinese mind-body integration , health-oriented practice designed to enhance the function of qi , an energy that sustains well-being .


Therefore , an assessor-blind , randomized , wait-list controlled trial was developed to evaluate the effect of a qigong intervention on telomerase activity ( primary objective ) and proinflammatory cytokines , perceived stress , perceived coping , and depressive symptoms ( secondary objectives ) in abused Chinese women .


A total of 240 Chinese women , aged 18 years , who have been abused by an intimate partner within the past three years will be recruited from a community setting in Hong Kong and randomized to receive either a qigong intervention or wait-list control condition as follows : the qigong intervention will comprise ( i ) a 2-hour group qigong training session twice a week for 6 weeks , ( ii ) a 1-hour follow-up group qigong exercise session once a week for 4 months , and ( iii ) a 30-minute self-practice qigong exercise session once a day for 5.5 months .


The wait-list control group will receive qigong training after the intervention group completes the program .


Upon completion of the qigong intervention program , it is expected that abused Chinese women in the intervention group will have higher levels of telomerase activity and perceived coping and lower levels of proinflammatory cytokines , perceived stress , and depressive symptoms than will abused Chinese women in the wait-list control group .


This study will provide information about the effect of qigong exercise on telomerase activity and chronic psychological stress in abused Chinese women .


The findings will inform the design of interventions to relieve the effects of IPV-related psychological stress on health .


Also , the concept that health-promoting behaviors could slow down cellular aging might even motivate abused women to change their lifestyles .


Current Controlled Trials NCT02060123 .


Registered February 6 , 2014 .


The present study was to assess the reduction of right ventricular pacing ( RVP ) by pacemaker algorithms of Managed Ventricular Pacing ( MVP ) and Search AV + ( SAV + ) interval over a period of 12 months .


A total of 385 patients indicated for a dual-chamber pacemaker ( DC-PM ) were enrolled in the prospective , randomized COMPARE study at 29 centres in China between June 2009 and April 2011 .


Patients implanted with DC-PMs were randomized in a 1 : 1 ratio to the MVP group or the SAV + group .


The percentage of VP ( % VP ) was obtained from the device diagnostic data at 1 - , 6 - , and 12-month follow-ups and was expressed as the median % VP over all beats in patients with sinus node dysfunction ( SND ) and atrioventricular block ( AVB ) excluding persistent third-degree AVB .


Of 385 enrolled patients , 253 had SND and 72 had AVB .


The % VP in the MVP group was significantly lower than that in the SAV + group at 1 - , 6 - , and 12-month follow-ups , respectively .


At 12-month follow-up , the median % VP in SND patients was 0.20 % in the MVP group and 1.4 % in the SAV + group ( P < 0.0001 ) and the median % VP in AVB patients was 11.8 % in the MVP group and 98.1 % in the SAV + group ( P < 0.001 ) .


There was no statistical difference in % VP from 1 - to 12-month follow-up .


A trend in the correlation between % VP and AT/AF burden was observed .


Over 12-month follow-up , the % VP was lower for MVP than SAV + in patients with either SND or AVB .


The sustainable % VP reduction has potential implications in reducing the development of heart failure and/or atrial arrhythmia morbidity .


Medical history is an important contributor to diagnosis and patient management .


In mass-casualty incidents ( MCIs ) , health care providers are often overwhelmed by large numbers of casualties .


An efficient , reliable , and affordable method of information collection is essential for effective health care response .


In some MCIs , self-reporting of symptoms can decrease the time required for history taking , without sacrificing the completeness of triage information .


Two resident doctors and a number of seventh graders who had previous experience of abdominal discomfort were invited to join this study .


A questionnaire was developed to collect information on common symptoms in food poisoning .


Each question was scored , and enrolled students were randomly divided into two groups .


The experimental group students answered the questionnaire first and then were interviewed to complete the medical history .


The control group students were interviewed in the traditional way to collect medical history .


Time of all interviews was measured and recorded .


The time needed to complete the history taking and completeness of obtained information were compared with students ' t tests , or Mann-Whitney U tests , based on the normality of data .


Comprehensibility of each question , scored by enrolled students , was reported by descriptive statistics .


There were 41 students enrolled : 22 in the experimental group and 19 in the control group .


Time to complete history taking in the experimental group ( 163.0 seconds , SD = 52.3 ) was shorter than that in the control group ( 198.7 seconds , SD = 40.9 ) ( P = .010 ) .


There was no difference in the completeness of history obtained between the experimental group and the control group ( 94.8 % , SD = 5.0 vs 94.2 % , SD = 6.1 ; P = .747 ) .


Between the two doctors , no significant difference was found in the time required for history taking ( 185.2 seconds , SD = 42.2 vs 173.1 seconds , SD = 58.6 ; P = .449 ) , or the completeness of information ( 94.1 % , SD = 5.9 vs 95.0 % , SD = 5.0 ; P = .601 ) .


Most of the questions were scored `` good '' in comprehensibility .


Self-reporting of symptoms can shorten the time of history taking during a food poisoning mass-casualty event without sacrificing the completeness of information .


Clinical weight loss in individuals typically stabilizes at 6 mo. .


However , validated models of dynamic energy balance have consistently shown weight plateaus between 1 and 2 y.


The cause for this discrepancy is unclear .


We developed 2 mathematical models on the basis of the first law of thermodynamics to investigate plausible explanations for reaching an early weight plateau at 6 mo. .


The first model was an energy-expenditure adaptation model and was applied to determine the degree of metabolic adaptation required to generate this plateau .


The second model was an intermittent lack-of-adherence model formulated by using a randomly fluctuating energy intake term accounting for intermittent noncompliance in dietary intake to reach this plateau .


To set model variables , validate models , and compare free-living weight-loss patterns to in-residence supervised programs , we applied the following 4 different studies : The US NHANES 1999-2004 , Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy ( CALERIE ) weight-loss study , the Bouchard Twin overfeeding study , and the Minnesota Starvation Experiment .


The metabolic adaptation model increased final weight but did not affect the predicted plateau time point .


The intermittent lack-of-adherence model generated oscillating weight graphs that have been frequently observed in weight-loss studies .


The model showed that a 6-mo weight-loss plateau can be attained despite what can be considered as high diet adherence .


The model was programmed as a downloadable application .


An intermittent lack of diet adherence , not metabolic adaptation , is a major contributor to the frequently observed early weight-loss plateau .


The new weight-loss prediction software , which incorporates an intermittent lack of adherence , can be used to guide and inform patients on realistic levels of adherence on the basis of patient lifestyle .


Despite sincere commitment to egalitarian , meritocratic principles , subtle gender bias persists , constraining women 's opportunities for academic advancement .


The authors implemented a pair-matched , single-blind , cluster randomized , controlled study of a gender-bias-habit-changing intervention at a large public university .


Participants were faculty in 92 departments or divisions at the University of Wisconsin-Madison .


Between September 2010 and March 2012 , experimental departments were offered a gender-bias-habit-changing intervention as a 2.5-hour workshop .


Surveys measured gender bias awareness ; motivation , self-efficacy , and outcome expectations to reduce bias ; and gender equity action .


A timed word categorization task measured implicit gender/leadership bias .


Faculty completed a work-life survey before and after all experimental departments received the intervention .


Control departments were offered workshops after data were collected .


Linear mixed-effects models showed significantly greater changes post intervention for faculty in experimental versus control departments on several outcome measures , including self-efficacy to engage in gender-equity-promoting behaviors ( P = .013 ) .


When 25 % of a department 's faculty attended the workshop ( 26 of 46 departments ) , significant increases in self-reported action to promote gender equity occurred at three months ( P = .007 ) .


Post intervention , faculty in experimental departments expressed greater perceptions of fit ( P = .024 ) , valuing of their research ( P = .019 ) , and comfort in raising personal and professional conflicts ( P = .025 ) .


An intervention that facilitates intentional behavioral change can help faculty break the gender bias habit and change department climate in ways that should support the career advancement of women in academic medicine , science , and engineering .


In a study of 266 chronic hepatitis B e antigen ( HBeAg ) - positive patients , 23 experienced hepatitis B surface antigen ( HBsAg ) loss with up to 5 years of tenofovir disoproxil fumarate ( TDF ) treatment .


HBsAg kinetics in patients with and without HBsAg loss and predictors of HBsAg loss were evaluated .


HBsAg levels were quantified every 12 weeks .


A multivariable regression analysis , involving prespecified baseline characteristics and on-treatment response parameters , was performed ; a stepwise procedure identified independent predictors of HBsAg loss .


Among patients with HBsAg loss , 14 ( 61 % ) , 1 ( 4 % ) , 0 and 7 ( 30 % ) were genotypes A through D , respectively ; 1 ( 4 % ) was genotype F. HBsAg loss was preceded by viral suppression ( HBV DNA < 29 IU/ml ; n = 23 ) and HBeAg loss ( n = 19 ) .


Among treated patients the strongest independent predictors of HBsAg loss were Caucasian race with genotype A/D and 4 years of infection ( HR = 14.3 , 95 % confidence interval [ CI ] 4.7-43 .4 ; p < 0.0001 ) and an HBsAg decline of 1 log10 IU/ml at week 24 ( HR = 13.7 , 95 % CI 5.6-33 .7 ; p < 0.0001 ) .


Among TDF-treated patients , a reduction in HBsAg level of 1-log10 by week 12 or 24 had a positive predictive value of 35 % -45 % , respectively , and a negative predictive value of 94 % -97 % , respectively .


HBsAg loss in HBeAg-positive patients receiving TDF involves a chronology of virologic and serologic responses ; patients with HBV genotypes A or D and a rapid early decline in HBsAg are more likely to lose HBsAg .


This is a secondary analysis of a randomized clinical trial which aims to examine changes in cognitive and behavioral responses to migraine with cognitive behavioral treatment for migraine , preventive medication for migraine , and their combination , and the relationship between these changes and reductions in migraine-related disability .


Cognitive behavioral treatment is thought to reduce migraine-related disability through modifying maladaptive cognitive and behavioral responses to migraine .


Two hundred thirty-two people with migraine who did not respond to 5 weeks of optimized acute therapy were randomized into a 2 ( beta-blocker vs placebo ) X 2 ( behavioral migraine management [ BMM ] vs no BMM ) treatment design .


Participants received BMM and/or beta-blocker dose adjustment for 4 months , and were followed for an additional 12 months .


Participants completed measures of catastrophizing , behavioral coping , and migraine-related disability throughout the study .


Compared to drug therapy only , BMM demonstrated larger decreases in catastrophizing scores ( 19.16 to 9.89 vs 16.78 to 11.84 , P < .001 ) and increases in number of positive coping strategies ( proactive : 1.09 to 1.90 vs 1.16 to 1.09 , P < .001 ; anticipatory : 0.19 to 0.69 vs 0.10 to 0.08 , P < .001 ; migraine management : 0.14 to 0.36 vs 0.04 to 0.04 , P < .001 ) at the end of the follow-up period .


Decreases in catastrophizing were associated with a larger BMM effect on migraine-related disability ( P = .036 ) .


This study demonstrated that BMM modified important cognitive and behavioral factors postulated to be mechanisms of cognitive behavioral treatments for migraine .


There is evidence from large clinical trials that compliance with standardized best practice guidelines ( BPGs ) improves survival of acute coronary syndrome ( ACS ) patients .


However , their application is often suboptimal .


In this study , the researchers evaluated whether the use of an interactive voice response ( IVR ) follow-up system improved ACS BPG compliance .


This was a single-centre randomized control trial ( RCT ) of 1,608 patients ( IVR = 803 ; usual care = 805 ) .


The IVR group received five automated calls in 12 months .


The primary composite outcome was increased medication compliance and decreased adverse events .


A significant improvement of 60 % in the IVR group for the primary composite outcome was found ( RR 1.60 , 95 % CI : 1.29 to 2.00 , p < 0.001 ) .


There was significant improvement in medication compliance ( p < 0.001 ) and decrease in unplanned medical visits ( p = 0.023 ) .


At one year , the majority of patients ( 85 % ) responded positively to using the system again .


Follow-up by IVR produced positive outcomes in ACS patients .


Although a large isolated surface area of the left atrium ( LA ) may improve the success rate of catheter ablation ( CA ) for paroxysmal atrial fibrillation ( AF ) , little is known about the relation between clinical outcomes and the amount of atrial mass reduction ( AMR : ratio of total isolated and ablated areas to LA surface area ) in different ablation strategies for patients with long-standing persistent AF ( L-PeAF ) .


We randomly assigned 119 consecutive L-PeAF patients to adjunctive linear ablation ( n = 60 ) or complex fractionated atrial electrogram ( CFAE ) - guided ablation ( n = 59 ) after circumferential antral pulmonary vein isolation ( PVI ) .


Linear lesions included roof and anterior lines with conduction block .


LA defragmentation was performed with an automated CFAE-detection algorithm .


Cavotricuspid isthmus block was performed in all patients .


Creatine kinase-MB ( CK-MB ) and troponin-T levels were measured 1 day post-CA .


CK-MB and troponin-T levels were higher , ablation time was longer , and AMR was greater in the CFAE-guided ablation group than in the linear ablation group .


AF termination during CA was more frequently observed in the linear ablation group than in the CFAE-guided ablation group ( P = 0.031 ) .


Twelve months after a single procedure , recurrence occurred in 16 ( 26.7 % ) patients with linear ablation and 27 ( 45.8 % ) patients with CFAE-guided ablation ( P = 0.023 ) .


On multivariate analysis , LA volume and ablation method were the only independent risk factors for arrhythmia recurrence .


Conduction block through linear lines + PVI was an efficient ablation strategy for L-PeAF , whereas the AMR amount did not influence clinical outcomes .


Around 30 % to 62 % of older individuals fall each year , with adverse consequences of falls being by no means limited to physical injury and escalating levels of dependence .


Many older individuals suffer from a variety of adverse psychosocial difficulties related to falling including fear , anxiety , loss of confidence and subsequent increasing activity avoidance , social isolation and frailty .


Such ` fear of falling ' is common and disabling , but definitive studies examining the effective management of the syndrome are lacking .


Cognitive behavioural therapy has been trialed with some success in a group setting , but there is no adequately powered randomised controlled study of an individually based cognitive behavioural therapy intervention , and none using non-mental health professionals to deliver the intervention .


We are conducting a two-phase study examining the role of individual cognitive behavioural therapy delivered by healthcare assistants in improving fear of falling in older adults .


In Phase I , the intervention was developed and taught to healthcare assistants , while Phase II is the pragmatic randomised controlled study examining the efficacy of the intervention in improving fear of falling in community-dwelling elders attending falls services .


A qualitative process evaluation study informed by Normalization Process Theory is being conducted throughout to examine the potential promoters and inhibitors of introducing such an intervention into routine clinical practice , while a health economic sub-study running alongside the trial is examining the costs and benefits of such an approach to the wider health economy .


Current Controlled Trials ISRCTN78396615 .


This study sought to determine whether the 1-year differences in major adverse cardiac event between a stent eluting biolimus from a biodegradable polymer and bare-metal stents ( BMSs ) in the COMFORTABLE trial ( Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction ) were sustained during long-term follow-up .


A total of 1161 patients were randomly assigned to biolimus-eluting stent ( BES ) and BMS at 11 centers , and follow-up rates at 2 years were 96.3 % .


A subgroup of 103 patients underwent angiography at 13 months .


At 2 years , differences in the primary end point of cardiac death , target-vessel myocardial infarction , and target lesion revascularization continued to diverge in favor of BES-treated patients ( 5.8 % ) compared with BMS-treated patients ( 11.9 % ; hazard ratio = 0.48 ; 95 % confidence interval , 0.31-0 .72 ; P < 0.001 ) with a significant risk reduction during the second year of follow-up ( hazard ratio 1-2 years = 0.45 ; 95 % confidence interval , 0.20-1 .00 ; P = 0.049 ) .


Differences in the primary end point were driven by a reduction in target lesion revascularization ( 3.1 % versus 8.2 % ; P < 0.001 ) and target-vessel reinfarction ( 1.3 % versus 3.4 % ; P = 0.023 ) .


The composite of death , any reinfarction and revascularization ( 14.5 % versus 19.3 % ; P = 0.03 ) , and cardiac death or target-vessel myocardial infarction ( 4.2 % versus 7.2 % ; P = 0.036 ) were less frequent among BES-treated patients compared with BMS-treated patients .


The 13-month angiographic in-stent percent diameter stenosis amounted to 12.0 7.2 in BES - and 39.6 25.2 in BMS-treated lesions ( P < 0.001 ) .


Among patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention , BES continued to improve cardiovascular events compared with BMS beyond 1 year .


http://www.clinicaltrials.gov .


Unique identifier : NTC00962416 .


Ad35.CS .01 is a pre-erythrocytic malaria candidate vaccine .


It is a codon optimized nucleotide sequence representing the P. falciparum circumsporozoite ( CS ) surface antigen inserted in a replication deficient Adenovirus 35 backbone .


A Phase 1a trial has been conducted in the USA in nave adults and showed that the vaccine was safe .


The aim of this study is to assess the safety and immunogenicity of ascending dosages in sub Saharan Africa .


A double blind , randomized , controlled , dose escalation , phase Ib trial was conducted in a rural area of Balonghin , the Sapon health district ( Burkina Faso ) .


Forty-eight healthy adults aged 18-45 years were randomized into 4 cohorts of 12 to receive three vaccine doses ( day 0 , 28 and 84 ) of 10 ( 9 ) , 10 ( 10 ) , 5X10 ( 10 ) , 10 ( 11 ) vp of Ad35.CS .01 or normal saline by intra muscular injection .


Subjects were monitored carefully during the 14 days following each vaccination for non serious adverse events .


Severe and serious adverse events were collected throughout the participant study duration ( 12 months from the first vaccination ) .


Humoral and cellular immune responses were measured on study days 0 , 28 , 56 , 84 , 112 and 140 .


Of the forty-eight subjects enrolled , forty-four ( 91.7 % ) received all three scheduled vaccine doses .


Local reactions , all of mild severity , occurred in thirteen ( 27.1 % ) subjects .


Severe ( grade 3 ) laboratory abnormalities occurred in five ( 10.4 % ) subjects .


One serious adverse event was reported and attributed to infection judged unrelated to vaccine .


The vaccine induced both antibody titers and CD8 T cells producing IFN and TNF with specificity to CS while eliciting modest neutralizing antibody responses against Ad35 .


Study vaccine Ad35.CS .01 at four different dose levels was well-tolerated and modestly immunogenic in this population .


These results suggest that Ad35.CS .01 should be further investigated for preliminary efficacy in human challenge models and as part of heterologous prime-boost vaccination strategies .


ClinicalTrials.gov NCT01018459 http://clinicaltrials.gov/ct2/show/NCT01018459 .


Diagnostic injections are used to diagnose myriad pain conditions , but are characterized by a high false-positive rate .


One potential cause of inaccurate diagnostic blocks is the use of sedation .


We sought to determine the effect of sedation on the validity of diagnostic injections .


Randomized , crossover study in which 73 patients were allocated to receive a diagnostic sacroiliac joint or sympathetic nerve block performed either with or without sedation using midazolam and fentanyl .


Those who obtained equivocal relief , good relief lasting less than 3 months , or who were otherwise deemed good candidates for a repeat injection , received a subsequent crossover injection within 3 months ( N = 46 ) .


A tertiary care teaching hospital and a military treatment facility .


In the primary crossover analysis , blocks performed with sedation resulted in a larger mean reduction in pain diary score than those done without sedation ( 1.2 [ 2.6 ] ; P = 0.006 ) , less procedure-related pain ( difference in means 2.3 [ 2.5 ] ; P < 0.0001 ) , and a higher proportion of patients who obtained > 50 % pain relief on their pain diaries ( 70 % vs. 54 % ; P = 0.039 ) .


The increased pain reduction was not accompanied by increased satisfaction ( sedation mean 3.9 [ 1.1 ] vs. 3.7 [ 1.3 ] ; P = 0.26 ) .


Similar findings were observed for the parallel group ( N = 73 ) and omnibus ( all sedation vs. no sedation blocks , N = 110 ) analyses .


No differences in outcomes were noted between the use and non-use of sedation at 1-month .


The use of sedation during diagnostic injections may increase the rate of false-positive blocks and lead to misdiagnoses and unnecessary procedures , but has no effect on satisfaction or outcomes at 1-month .


Biventricular pacing in heart failure ( HF ) improves survival , relieves symptoms , and attenuates left ventricular ( LV ) remodeling .


However , little is known about biventricular pacing in HF patients with atrioventricular block because they are typically excluded from biventricular trials .


The Biventricular versus Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block ( BLOCK HF ) trial randomized patients with atrioventricular block , New York Heart Association symptom classes I to III HF , and LV ejection fraction 50 % to biventricular or right ventricular pacing .


Doppler echocardiograms were obtained at randomization ( after 30 to 60 days of right ventricular pacing postimplant ) and every 6 months through 24 months .


Data analysis comparing changes in 10 prespecified echo parameters over time was conducted using a Bayesian design .


LV end systolic volume index was also evaluated as a predictor of mortality/morbidity .


Of 691 randomized subjects , 624 had paired Doppler echocardiogram data for 1 analyses at 6 , 12 , 18 , or 24 months .


Biventricular pacing significantly reduced LV volume indices and intraventricular mechanical delay , and improved LV ejection fraction , consistent with LV reverse remodeling .


These parameters showed little change with right ventricular pacing alone , indicating no systematic reverse remodeling with right ventricular pacing .


LV end systolic volume index was predictive of mortality/morbidity ; the estimated risk increased up to 1 % for every 1 mL/m ( 2 ) increase in LV end systolic volume index .


LV end systolic volume index is a significant predictor of mortality/morbidity in this population .


Cardiac structure and function are improved with biventricular pacing for patients with atrioventricular block and LV systolic dysfunction .


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


Unique identifier : NCT00267098 .


To compare the efficacy , safety and postoperative pain of mechanical versus transepithelial photorefractive keratectomy ( PRK ) techniques .


Cornea and refractive surgery subspecialty .


Prospective clinical trial .


This prospective comparative study included 84 eyes of 42 patients with myopia who received mechanical PRK ( m-PRK ) in 1 eye and transepithelial PRK ( t-PRK ) in the contralateral eye .


The mean patient age was 28.56.3 years ( range 20-46 years ) .


Postoperative uncorrected distance visual acuity ( UDVA ) , corrected distance visual acuity ( CDVA ) , manifest refractions , postoperative epithelial healing time , surgical time , postoperative pain rating and corneal haze were recorded .


At week 1 , statistically the UDVA was significantly better in the t-PRK eyes ; however , at 3 months , similar refractive stability was achieved in both groups .


The mean spherical equivalent ( SE ) decreased from -2.441.00 D ( m-PRK eyes ) and -2.881.24 D ( t-PRK eyes ) at baseline to -0.190.38 D and -0.300.40 D , respectively , after 1 year .


Surgical time was 98.69.8 s in m-PRK eyes and 58.06.4 s in t-PRK eyes .


On postoperative days 1 and 3 , using the global assessment rating , 81 % of mPRK eyes that had pain , reported more pain than that reported for the tPRK eyes .


In addition , m-PRK treated eyes demonstrated higher mean pain scores based on the 11-point numerical rating scale and Visual Analogue Scale ( VAS ) .


The mean time to complete epithelial healing was 2.190.39 days ( t-PRK ) and 3.760.43 days ( m-PRK ) .


t-PRK for mild-to-moderate myopia was more comfortable than conventional m-PRK ; patients had less pain , and faster healing time .


To report late toxicity outcomes from a randomized trial comparing conventional and hypofractionated prostate radiation therapy and to identify dosimetric and clinical parameters associated with late toxicity after hypofractionated treatment .


Men with localized prostate cancer were enrolled in a trial that randomized men to either conventionally fractionated intensity modulated radiation therapy ( CIMRT , 75.6 Gy in 1.8-Gy fractions ) or to dose-escalated hypofractionated IMRT ( HIMRT , 72 Gy in 2.4-Gy fractions ) .


Late ( 90 days after completion of radiation therapy ) genitourinary ( GU ) and gastrointestinal ( GI ) toxicity were prospectively evaluated and scored according to modified Radiation Therapy Oncology Group criteria .


101 men received CIMRT and 102 men received HIMRT .


The median age was 68 , and the median follow-up time was 6.0 years .


Twenty-eight percent had low-risk , 71 % had intermediate-risk , and 1 % had high-risk disease .


There was no difference in late GU toxicity in men treated with CIMRT and HIMRT .


The actuarial 5-year grade 2 GU toxicity was 16.5 % after CIMRT and 15.8 % after HIMRT ( P = .97 ) .


There was a nonsignificant numeric increase in late GI toxicity in men treated with HIMRT compared with men treated with CIMRT .


The actuarial 5-year grade 2 GI toxicity was 5.1 % after CIMRT and 10.0 % after HIMRT ( P = .11 ) .


In men receiving HIMRT , the proportion of rectum receiving 36.9 Gy , 46.2 Gy , 64.6 Gy , and 73.9 Gy was associated with the development of late GI toxicity ( P < .05 ) .


The 5-year actuarial grade 2 GI toxicity was 27.3 % in men with R64 .6 Gy 20 % but only 6.0 % in men with R64 .6 Gy < 20 % ( P = .016 ) .


Dose-escalated IMRT using a moderate hypofractionation regimen ( 72 Gy in 2.4-Gy fractions ) can be delivered safely with limited grade 2 or 3 late toxicity .


Minimizing the proportion of rectum that receives moderate and high dose decreases the risk of late rectal toxicity after this hypofractionation regimen .


High circulating levels of osteoprotegerin ( OPG ) carry prognostic impact in cohorts with various cardiovascular diagnoses .


With the present study , we aim to investigate the role of OPG within the scale of myocardial damage .


This study includes 219 consecutive patients with acute ST-elevation myocardial infarction randomized to primary percutaneous coronary intervention ( pPCI ) or pPCI and remote ischemic per-conditioning .


Salvage index via myocardial single-photon emission CT assessment ( data available in 61 % of the patients ) was performed , and derived from Day 1 ( myocardial area at risk ) and Day 30 ( final infarct size ) .


Plasma OPG levels were measured using an in-house immunoassay .


A combined end-point of all-mortality , myocardial infarction , stroke , readmission for heart failure and ischemic stroke/transient ischemic attack ( Major Adverse Cardiac and Cerebrovascular Events [ MACCE ] ) was used for follow-up ; 45 ( 38-48 months ) .


High OPG levels were associated with the severity of cardiovascular disease .


During follow-up , OPG was a predictor of MACCE ( unadjusted , HR : 2.1 , 95 % CI : 1.14-3 .85 , P = 0.017 ) .


Adjustments for age , gender , and body mass index preserved the independent predictive power of OPG .


However , OPG levels were neither associated with salvage index nor with the final infarct size .


Remote ischemic per-conditioning had no effect on OPG levels .


Despite absent association between OPG levels and the scale of myocardial damage , high OPG levels predict a significantly increased risk of MACCE .


Life expectancy in patients with schizophrenia is reduced by 20years for males and 15years for females compared to the general population .


About 60 % of the excess mortality is due to physical illnesses , with cardiovascular disease being the single largest cause of death .


The CHANGE trial is an investigator-initiated , independently funded , randomized , parallel-group , superiority , multi-centre trial with blinded outcome assessment .


450 patients aged 18years or above , diagnosed with schizophrenia spectrum disorders and increased waist circumference , will be recruited and randomized 1:1:1 to 12-months interventions .


We will compare the effects of 1 ) affiliation to the CHANGE team , offering a tailored , manual-based intervention targeting physical inactivity , unhealthy dietary habits , and smoking , and facilitating contact to their general practitioner to secure medical treatment of somatic comorbidity ; versus 2 ) affiliation to a care coordinator who will secure guideline-concordant monitoring and treatment of somatic comorbidity by facilitating contact to their general practitioner ; versus 3 ) treatment as usual to evaluate the potential add-on effects of lifestyle coaching plus care coordination or care coordination alone to treatment as usual .


The primary outcome is the 10-year risks of cardiovascular disease assessed at 12months after randomization .


The premature mortality observed in this vulnerable population has not formerly been addressed specifically by using composite surrogate outcomes for mortality .


The CHANGE trial expands the evidence for interventions aiming to reduce the burden of metabolic disturbances with a view to increase life expectancy .


Here , we present the trial design , describe the methodological concepts in detail , and discuss the rationale and challenges of the intermediate outcomes .


Clinical Trials.gov NCT01585493 .


Date of registration 27 ( th ) of March 2012 .


Implanted insulin pumps using the peritoneal route provide long-term improvement of glucose control compared with subcutaneous insulin therapy in type 1 diabetes ( T1D ) patients .


The stability of insulin preparation is critical for a safe use in implanted pumps .


Insuman implantable ( ) ( 400IU/mL ) ( Sanofi-Aventis Deutschland GmbH , Frankfurt am Main , Germany ) , a recombinant human insulin , has been developed as a replacement for Insuplant ( ) ( Aventis Pharma , Frankfurt am Main , Germany ) , a semisynthetic insulin , the only one used so far .


The aim of the study was to demonstrate the noninferiority of Insuman versus Insuplant , in terms of safety and effectiveness when used in implanted pumps .


The patients enrolled , currently treated for T1D by the Medtronic MiniMed ( Northridge , CA ) implantable pump model 2007 with Insuplant , were randomized into two study arms and received either Insuman or Insuplant for four pump refill cycles .


Each pump refill cycle was 405 days .


The co-primary end points included glycated hemoglobin ( HbA1c ) change from baseline and pump infusion accuracy .


In total , 169 patients were randomized .


Noninferiority of Insuman versus Insuplant was demonstrated both for the HbA1c change from baseline ( as a percentage ) with intergroup difference of 95 % confidence interval ( -0.36 ; +0.11 ) and for the infusion accuracy assessed by the measured percentage of error at pump refill , as shown by intergroup difference of 95 % confidence interval ( -5.81 ; -0.50 ) , in per-protocol populations , although the insulin daily dose was similar .


Severe hypoglycemia occurred at least once in 12 versus 11 patients , respectively , and metabolic or technical adverse events were comparable .


Findings suggest that Insuman can safely and effectively replace Insuplant in implanted pumps .


To compare laser photocoagulation plans for diabetic macular edema ( DME ) using fluorescein angiography ( FA ) versus optical coherence tomography ( OCT ) thickness map superimposed on the retina .


Fourteen eyes with DME undergoing navigated laser photocoagulation with navigated photocoagulator had FA taken using the same instrument .


Optical coherence tomography central retinal thickness map was imported to the photocoagulator and with same magnification aligned onto the retina .


Three retina specialists placed laser spot marks separately on FA and OCT image in a masked fashion .


The spots placed by each physician were compared between FA and OCT and among physicians .


The area of dye leakage on FA and increased central retinal thickness on OCT of the same eye were also compared .


The average number of spots using FA and OCT template was 36.64 and 40.61 , respectively ( P = 0.0201 ) .


The average area of dye leakage was 7.45 mm , whereas the average area of increased central retinal thickness on OCT of the same eye was 10.92 mm ( P = 0.013 ) .


There is variability in the treatment planning for macular photocoagulation with a tendency to place more spots when guided by OCT than by FA .


Integration of OCT map aligned to the retina may have an impact on treatment plan once such information is available .


To evaluate the effectivity of a combined intervention of information and communication to reduce magnetic resonance imaging ( MRI ) anxiety using prolactin and cortisol as biochemical markers and State Trait Anxiety Inventory ( STAI ) .


This study is a randomized prospective research .


Sample size was 33 patients .


Fourteen patients were enrolled as study group , compared to 19 patients as control group .


Blood samples were collected by venous sampling , and STAI was filled before and after scan .


State anxiety inventory was used twice .


Study group received a standard information about MRI scans and were communicated with 2 minute intervals via intercom ; control group had no intervention .


Blood samples were carried in ice to be centrifuged and stored as soon as they were taken to study prolactin and cortisol .


Data were stored and analyzed by SPSS 17.0 .


P value for significance was accepted as 0.05 .


Prolactin-pre , prolactin-post , cortisol-pre , cortisol-post , cortisol percent increase , Trait Anxiety Inventory ( TAI ) , SAI ( State Anxiety Inventory ) pre-scan and post-scan levels were similar between demographic groups .


Cortisol-pre levels were similar between study and control , however prolactin-pre levels were significantly higher in control group .


Study group had 6 % lower cortisol level post-scan , whereas control group had 18 % increase .


Study and control groups had similar Trait Anxiety and SAI-pre scores .


SAI-post scores were lower in study group when compared with control group .


Study group also had lower SAI-post scores than SAI-pre , whereas control group had higher .


MRI anxiety can be reduced by information and communication .


This combined method is shown to be effective and should be used during daily radiology routine .


Contrast-induced nephropathy ( CIN ) is a serious condition in patients with ST-segment-elevation myocardial infarction treated with primary percutaneous coronary intervention .


We compared the risk of acute CIN and the influence of preventive strategies in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention .


A total of 720 patients were randomized in the Prevention of Contrast-induced Nephropathy in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention ( CINSTEMI ) trial .


Patients were randomly assigned in a 1:1:1:1 ratio to receive hydration with sodium chloride together with 1 of 4 prophylactic regimes ( 1 ) N-acetylcysteine ( NAC ) , ( 2 ) sodium bicarbonate ( NaHCO3 ) infusion , ( 3 ) NAC in combination with NaHCO3 , or ( 4 ) hydration with sodium chloride infusion alone .


Patients in cardiogenic shock were excluded .


Acute CIN was defined as an increase in serum creatinine concentration > 25 % from the baseline value within a 3-day period .


Overall , CIN occurred in 141 ( 21.9 % ) patients .


The prevention treatment with NAC , NaHCO3 , or the combined NAC and NaHCO3 did not reduce the rate of CIN significantly compared with hydration with intravenous sodium chloride infusion alone ( 20.1 % versus 20.1 % versus 20.8 % versus 26.5 % ; P = NS ) .


However , an increase in serum creatinine > 25 % from the baseline value to 30 day was significantly lower in patients treated with combined NAC and NaHCO3 ( 18.7 % versus 19.1 % versus 9.2 % versus 21.3 % ; P = 0.033 ) .


Treatment with NAC or NaHCO3 did not reduce the rate of acute CIN significantly .


Combined treatment with NAC and NaHCO3 may reduce the risk of renal dysfunction after 30 days .


http://www.clinicaltrials.gov .


Unique identifier : NCT01160627 .


To evaluate the efficacy and safety of subcutaneous blisibimod , an inhibitor of B cell activating factor , in patients with systemic lupus erythematosus ( SLE ) in a dose-ranging Phase 2b clinical trial .


547 patients with SLE with anti-double stranded DNA or antinuclear antibodies and Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index ( SELENA-SLEDAI ) score 6 at baseline were randomised to receive placebo or blisibimod at one of 3 dose levels .


The primary end point , measured at Week 24 , was the SLE Responder Index-5 ( SRI-5 , meeting established SRI criteria but with 5 point improvement in SELENA-SLEDAI ) .


Although SRI-5 response rates were not significantly improved in the pooled blisibimod groups compared with placebo , they were higher in subjects randomised to the highest dose of blisibimod ( 200mg once-weekly ( QW ) ) compared with pooled placebo , from Week 16 to Week 24 , reaching statistical significance at Week 20 ( p = 0.02 ) .


SRI response rates compared with placebo were higher still in subjects who attained SELENA-SLEDAI improvements of 8 , and in a subgroup of patients with severe disease ( SELENA-SLEDAI 10 and receiving corticosteroids at baseline ) .


In subjects with protein : creatine ratios of 1-6 at baseline , significant reductions in proteinuria were observed with blisibimod .


Significant ( p < 0.01 ) changes in anti-double stranded DNA antibodies , complement C3 and C4 , and reductions in B cells were observed with blisibimod.No imbalances in serious adverse events or infections ( 4/280 and 3/266 ) , deaths ( 4/280 and 3/266 ) and malignancies ( 2/280 and 2/266 ) were reported for blisibimod compared with placebo .


This study successfully identified a safe , effective and convenient dose , study population and end point for evaluation of blisibimod effect in Phase 3 .


NCT01162681 .


To assess the efficacy and safety of Xifeng Zhidong Tablet ( XZT ) in treating tic disorder children patients of internal disturbance of Gan-wind with phlegm syndrome ( IDGWPS ) .


A stratified randomized , double-blinded , parallel control of placebo , multi-center trial was conducted in 160 subjects from 5 hospitals in China .


They were randomly assigned to 2 groups , the test group and the control group , 80 in each group .


Those in the test group were treated with XZT , while those in the control group were treated with placebos .


The therapeutic course was 4 weeks for all .


The effectiveness indicators covered main indicators and secondary indicators .


Yale global tic severity scale ( YGTSS ) was taken as the main indicators .


The amelioration of social function impairment , efficacy , single index of Chinese medical syndromes , Chinese medical syndrome efficacy as well as disappearance rate of single Chinese medical symptoms were evaluated as secondary indicators .


The safety indicators included clinical adverse events , vital signs , blood/urine/stool routines , renal and liver functions , and electrocardiogram ( ECG ) .


As for main indicators , the score of YGTSS decreased from 22.10 + / - 6.38 to 11.34 + / - 6.58 in the test group , while it decreased from 22.65 + / - 6.70 to 16.82 + / - 6.53 in the control group , showing statistical difference when compared with the same group before treatment ( P < 0.01 ) .


Besides , the decrement was more significant in the test group after treatment ( P < 0.05 ) .


As for secondary indicators , the total effective rate was 83.54 % in the test group and 34.18 % in the controlled group , showing statistical difference between the two groups ( P < 0.05 ) .


As for social function impairment , 20,38 , 16 , 3 , 1 case ( s ) in the test group were ranked as normal , minimal , mild , moderate , obvious degree , while 1 , 24 , 45 , 7 , and 0 case ( s ) in the control group were ranked as normal , minimal , mild , moderate , obvious degree .


Better effect was obtained in the test group ( P < 0.05 ) .


As for Chinese medical syndrome efficacy , it was 87.34 % in the test group and 64.56 % in the control group ( P < 0.05 ) .


As for single index of Chinese medical syndromes , the disappearance rate of motor tics , irritability , dreaminess , abnormal tongue proper , abnormal tongue fur , and abnormal tongue pulse condition was 78.67 % , 34.72 % , 62.26 % , 34.62 % , 58.97 % , and 39.74 % , respectively in the test group , while they were 34.67 % , 13.11 % , 21.82 % , 15.58 % , 25.97 % , and 19.48 % , respectively in the control group .


Better results were shown in the test group ( P < 0.05 ) .


Totally 5 adverse events occurred .


The incidence of adverse events was 3.75 % in the test group and 2.53 % in the control group .


After 4 weeks of XZT treatment , the integral of YGTSS could be obviously reduced , the degree of social function impairment ameliorated , and Chinese medical syndromes improved .


In addition , no adverse reaction occurred in this study .


The study sought to evaluate the influence of gastroesophageal reflux disease ( GERD ) and allergy on subacute rhinitis in infants .


Mothers of 74 infants with subacute rhinitis completed the Infant Gastroesophageal Reflux Questionnaire Revised .


Participants with GERD were randomized to undergo one of the following regimens for 10 days : use of fluorometholone nasal drops with positional and feeding changes ; positional and feeding changes ; or a placebo .


The daily amount of nasal secretion decreased by 75.9 % ( p < 0.001 ) , the intensity of swallowing difficulty by 79.2 % ( p < 0.001 ) , and the incidence of uneasiness by 92.0 % ( p < 0.001 ) in infants treated with nasal glucocorticoid and positional and feeding changes ; and the percentage differences in the amount of nasal secretion ( p < 0.001 ) , feeding difficulty ( p < 0.001 ) , and uneasiness ( p < 0.001 ) were greater than those in the group treated with positional and feeding changes .


The infants treated with placebo did not improve .


The influence of nasal allergy was nonsignificant .


Gastroesophageal reflux disease might contribute to aggravation of subacute rhinitis in infants .


Several rehabilitation programmes aim at reducing the impact of fatigue in MS patients .


Acute and chronic fatigue should require different management .


To assess the effects of individually tailored , multidisciplinary outpatient rehabilitation ( MDR ) on chronic fatigue .


Forty-eight ambulatory MS patients with chronic fatigue were randomized to MDR or to MS-nurse consultation .


Fatigue was assessed by the Checklist Individual Strength ( CIS-20R ) .


Secondary outcomes included the Modified Fatigue Impact Scale , Fatigue Severity Scale , Functional Independence Measure , Disability and Impact Profile ( DIP ) , Multiple Sclerosis Impact Scale and the Impact on Participation and Autonomy ( IPA ) .


The primary outcome measure CIS-20R overall score showed no significant differences between groups at 12 weeks ( P = 0.39 ) and 24 weeks follow-up ( P = 0.14 ) , nor for subscales ( t = 12 and t = 24 , 0.19 P0 .88 ) .


No significant within-group effects were found for both groups with respect to the primary ( 0.57 p0 .97 ) and secondary ( 0.11 p0 .92 ) outcome measures from baseline to 12 or 24 weeks .


Multidisciplinary rehabilitation was not more effective in terms of reducing self-reported fatigue in MS patients compared to MS-nurse consultation .


Our results suggest that chronic fatigue in patients with MS may be highly invariant over time , irrespective of interventions .


controlled-trials .


com ISRCTN05017507 .


Somatostatin analogues are commonly used to treat symptoms associated with hormone hypersecretion in neuroendocrine tumors ; however , data on their antitumor effects are limited .


We conducted a randomized , double-blind , placebo-controlled , multinational study of the somatostatin analogue lanreotide in patients with advanced , well-differentiated or moderately differentiated , nonfunctioning , somatostatin receptor-positive neuroendocrine tumors of grade 1 or 2 ( a tumor proliferation index [ on staining for the Ki-67 antigen ] of < 10 % ) and documented disease-progression status .


The tumors originated in the pancreas , midgut , or hindgut or were of unknown origin .


Patients were randomly assigned to receive an extended-release aqueous-gel formulation of lanreotide ( Autogel [ known in the United States as Depot ] , Ipsen ) at a dose of 120 mg ( 101 patients ) or placebo ( 103 patients ) once every 28 days for 96 weeks .


The primary end point was progression-free survival , defined as the time to disease progression ( according to the Response Evaluation Criteria in Solid Tumors , version 1.0 ) or death .


Secondary end points included overall survival , quality of life ( assessed with the European Organization for Research and Treatment of Cancer questionnaires QLQ-C30 and QLQ-GI .


NET21 ) , and safety .


Most patients ( 96 % ) had no tumor progression in the 3 to 6 months before randomization , and 33 % had hepatic tumor volumes greater than 25 % .


Lanreotide , as compared with placebo , was associated with significantly prolonged progression-free survival ( median not reached vs. median of 18.0 months , P < 0.001 by the stratified log-rank test ; hazard ratio for progression or death , 0.47 ; 95 % confidence interval [ CI ] , 0.30 to 0.73 ) .


The estimated rates of progression-free survival at 24 months were 65.1 % ( 95 % CI , 54.0 to 74.1 ) in the lanreotide group and 33.0 % ( 95 % CI , 23.0 to 43.3 ) in the placebo group .


The therapeutic effect in predefined subgroups was generally consistent with that in the overall population , with the exception of small subgroups in which confidence intervals were wide .


There were no significant between-group differences in quality of life or overall survival .


The most common treatment-related adverse event was diarrhea ( in 26 % of the patients in the lanreotide group and 9 % of those in the placebo group ) .


Lanreotide was associated with significantly prolonged progression-free survival among patients with metastatic enteropancreatic neuroendocrine tumors of grade 1 or 2 ( Ki-67 < 10 % ) .


( Funded by Ipsen ; CLARINET ClinicalTrials.gov number , NCT00353496 ; EudraCT 2005-004904-35 . )


Endoscopic treatment of early neoplastic lesions in oesophagus has evolved as a valid and less invasive alternative to surgical resection .


These endoscopic interventions are minimal invasive treatment options usually done with sedation on an outpatient basis .


The aim of this trial is to determine the safety and effectiveness of dexmedetomidine sedation compared to the standard used propofol TCI sedation during endoscopic oesophageal interventions .


The study will be performed as a randomized controlled trial .


The first 64 consenting patients will be randomized to either the propofol or the dexmedetomidine group .


Following endoscopy patients and gastroenterologists have to fill in questionnaires ( PSSI , CSSI ) ( see abbreviations ) about their sedation experiences .


Additionally , patients have to accomplish the Trieger test before and after the procedure .


Patient monitoring includes time adapted HR , SO , ECG , NIBP , exCO , NICO , sweat conductance measurement , OAA/S , and the Aldrete score .


Effectiveness of sedation , classified by satisfaction levels and pain and sedation score measured by questionnaires is the primary outcome parameter .


Respiratory and hemodynamic complications are surrogate parameters for the secondary outcome parameter `` safety '' .


The acceptance level among patients after propofol sedation is high .


Dexmedetomidine is a relatively new representative for procedural sedation .


Has this new form of conscious sedation the potential to be safer and more effective for patients and endoscopists than propofol during endoscopic oesophageal interventions ?


This trial is registered in the ISRCTN Register ( ISRCTN 68599804 ) .


It will be conducted in accordance with the protocol and in compliance with the moral , ethical , and scientific principles governing clinical research as set out in the Declaration of Helsinki ( 1989 ) and Good Clinical Practice ( GCP ) .


The Departments of Anesthesiology and Gastroenterology & Hepatology of the Academic Medical Center of Amsterdam are responsible for the design and conduct of the trial .


Anemia is a common adverse event associated with telaprevir-based triple therapy of chronic , genotype 1 hepatitis C. Identification of patients at risk of developing anemia could allow evaluation of suitability for therapy , and aid in determining frequency of anemia monitoring and treatment management .


This post-hoc analysis utilized data from the no lead-in telaprevir , peginterferon and ribavirin arm of the REALIZE study .


Anemia was defined as a single occurrence of hemoglobin < 10 g/dl at any point during treatment .


Pre-treatment factors with potential to act as prognostic indicators of anemia including age , sex , BMI , and baseline hemoglobin were analysed by univariate and multivariate logistic regression analyses .


Nomograms ( graphical representations of risk factors ) were developed to predict the likelihood of developing anemia .


Among the 265 patients , 102 ( 38 % ) had anemia , with 78/102 ( 77 % ) developing anemia on or before week 12 .


Most patients developed anemia after week 2 and an inverse correlation was found between week 2 hemoglobin and the likelihood of developing anemia .


Overall , 60 % of patients ( 60/100 ) with week 2 hemoglobin < 13 g/dl subsequently developed anemia .


The multivariate analysis revealed older age ( > 45 years ) , lower BMI ( 25 mg/m ( 2 ) ) and baseline hemoglobin ( continuous variable ) were significantly associated with the probability of developing anemia during telaprevir treatment .


These analyses indicate the potential of using predictive risk factors such as low baseline and on-treatment hemoglobin to identify patients at risk of developing anemia on telaprevir-based triple therapy , which may increase the potential for treatment success by careful patient monitoring .


After posterior urethral valve ablation , some boys are still have a hostile bladder .


We conducted a prospective randomized study to determine if Botox injection at the bladder neck will help improve vesical dysfunction in this subgroup of boys or not .


Twenty boys with history of posterior urethral valve ablation and severe bladder dysfunction with a mean age of 16 months were studied .


Cases were further randomized into two groups .


Group I ( study group ) had endoscopic injection of a single dose of 100 IU of Botox into the hypertrophied bladder neck at 3 , 6 , and 9 o'clock .


Group II ( control group ) patients with the same parameters had urethroscopy to exclude residual valves .


Both groups had the standard conservative treatment .


Cases were followed after 6 months of initiating the management protocol .


This includes laboratory studies ( urine culture and sensitivity , blood urea nitrogen , serum creatinine ) , ultrasound of the urinary tract .


Voiding cysto-urethrogram and urodynamic study ( pressure flow study ) .


There was no statistical difference in both groups regarding rate of urinary tract infection , improvement of hydronephrosis , resolution of vesico-ureteral reflux , creatinine level at the start or at the end of the study .


Urodynamic parameters revealed an increase in cystometric capacity in both groups at the end of the study but without statistical difference .


The mean voiding pressure reduced significantly in both groups but without statistical difference .


Temporarily abolishing the effect of bladder neck by Botox injection does not seem to improve the outcome of those boys who had a severe voiding dysfunction after valve ablation .


Heart rate variability ( HRV ) is reduced in stable ischemic heart disease ( SIHD ) patients and is associated with sudden cardiac death ( SCD ) .


We evaluated the impact of traditional acupuncture ( TA ) on cardiac autonomic function measured by HRV in SIHD patients .


We conducted a randomized controlled study of TA , sham acupuncture ( SA ) , and waiting control ( WC ) in 151 SIHD subjects .


The TA group received needle insertion at acupuncture sites , the SA group received a sham at non-acupuncture sites , while the WC group received nothing .


The TA and SA groups received 3 treatments/week for 12 weeks .


24-Hour , mental arithmetic stress , and cold pressor ( COP ) HRV was collected at entry and exit , along with BP , lipids , insulin resistance , hs-CRP , salivary cortisol , peripheral endothelial function by tonometry ( PAT ) , and psychosocial variables .


Mean age was 63 10 ; 50 % had prior myocardial infarction .


Comparison of WC and SA groups demonstrated differences consistent with the unblinded WC status ; therefore by design , the control groups were not merged .


Exit mental stress HRV was higher in TA vs. SA for markers of parasympathetic tone ( p 0.025 ) , including a 17 % higher vagal activity ( p = 0.008 ) .


There were no differences in exit 24-hour or COP HRV , BP , lipids , insulin resistance , hs-CRP , salivary cortisol , PAT , or psychosocial variables .


TA results in intermediate effects on autonomic function in SIHD patients .


TA effect on HRV may be clinically relevant and should be explored further .


These data document feasibility and provide sample size estimation for a clinical trial of TA in SIHD patients for the prevention of SCD .


We conducted a randomized , single-blind trial of traditional acupuncture ( TA ) vs. sham acupuncture ( SA ) vs waiting control ( WC ) in stable ischemic heart disease ( SIHD ) patients to evaluate cardiac autonomic function measured by heart rate variability ( HRV ) .


Exit mental stress HRV was higher in the TA compared to SA group for time and frequency domain markers of parasympathetic tone ( all p 0.025 ) , including a 17 % higher vagal activity ( p = 0.008 ) .


These data document feasibility and provide sample size estimation for an outcome-based clinical trial of TA in SIHD patients for the prevention of sudden cardiac death .


To evaluate the impact of nocturia on the therapeutic response of chronic insomnia to behavioral treatment in older adults .


Secondary analysis of a randomized clinical trial designed to assess the efficacy of brief behavioral treatment of insomnia ( BBTI ) vs. an information-only control ( IC ) in 79 community-dwelling older adults with chronic insomnia .


For the current analysis , participants were stratified into 2 groups : those with self-reported nocturia at baseline i.e. , 1 void/night ( N = 30 ; 16 IC , 14 BBTI ) and those without nocturia ( N = 49 ; 24 IC , 25 BBTI ) .


We then determined the impact of BBTI on sleep , sleep quality , and nocturia as assessed by self-report , actigraphy , and polysomnography .


Individuals without baseline nocturia responded well to BBTI with significant decrease in sleep latency , wake after sleep onset , and total sleep time assessed by sleep diary and actigraphy ; these changes were significantly greater than those in the IC group .


In comparison , changes in the same sleep parameters among participants with nocturia were not significantly different from the IC control .


Although BBTI showed significant improvement in sleep quality in groups with and without nocturia ( as assessed by PSQI and sleep diary ) , the effect size of these improvements was larger in those without nocturia than in those with nocturia ( PSQI d = 0.82 vs. 0.53 , diary sleep quality d = 0.83 vs. 0.51 ) .


These secondary analyses suggest that brief behavioral treatment of insomnia may be more efficacious in improving insomnia in participants without nocturia .


Addressing nocturia may improve the efficacy of behavioral insomnia treatment .


To assess the effectiveness of a weighted-blanket intervention in treating severe sleep problems in children with autism spectrum disorder ( ASD ) .


This phase III trial was a randomized , placebo-controlled crossover design .


Participants were aged between 5 years and 16 years 10 months , with a confirmed ASD diagnosis and severe sleep problems , refractory to community-based interventions .


The interventions were either a commercially available weighted blanket or otherwise identical usual weight blanket ( control ) , introduced at bedtime ; each was used for a 2-week period before crossover to the other blanket .


Primary outcome was total sleep time ( TST ) recorded by actigraphy over each 2-week period .


Secondary outcomes included actigraphically recorded sleep-onset latency , sleep efficiency , assessments of child behavior , family functioning , and adverse events .


Sleep was also measured by using parent-report diaries .


Seventy-three children were randomized and analysis conducted on 67 children who completed the study .


Using objective measures , the weighted blanket , compared with the control blanket , did not increase TST as measured by actigraphy and adjusted for baseline TST .


There were no group differences in any other objective or subjective measure of sleep , including behavioral outcomes .


On subjective preference measures , parents and children favored the weighted blanket .


The use of a weighted blanket did not help children with ASD sleep for a longer period of time , fall asleep significantly faster , or wake less often .


However , the weighted blanket was favored by children and parents , and blankets were well tolerated over this period .


In a subset of children with unilateral Cerebral Palsy ( CP ) a discrepancy between capacity and performance of the affected upper limb can be observed .


This discrepancy is known as Developmental Disregard ( DD ) .


Though the phenomenon of DD has been well documented , its underlying cause is still under debate .


DD has originally been explained based on principles of operant conditioning .


Alternatively , it has been proposed that DD results from a diminished automaticity of movements , resulting in an increased cognitive load when using the affected hand .


To investigate the amount of involved cognitive load we studied Event-Related Potentials ( ERPs ) preceding task-related motor responses during a single-hand capacity and a dual-hand performance task .


It was hypothesised that children with DD show alterations related to long-latency ERP components when selecting a response with the affected upper limb , reflecting increased cognitive load in order to generate an adequate response and especially so within the dual-hand task .


Fifteen children with unilateral CP participated in the study .


One of the participants was excluded due to major visual impairments .


Seven of the remaining participants displayed DD .


The other seven children served as a control group .


All participants performed two versions of a cue-target paradigm , a single-hand capacity and a dual-hand performance task .


The ERP components linked to target presentation were inspected : the mid-latency P2 component and the consecutive long-latency N2b component .


In the dual-hand performance task children with DD showed an enhancement in mean amplitude of the long-latency N2b component when selecting a response with their affected hand .


No differences were found regarding the amplitude of the mid-latency P2 component .


No differences were observed regarding the single-hand capacity task .


The control group did not display any differences in ERPs linked to target evaluation processes between both hands .


These electrophysiological findings show that DD is associated with increased cognitive load when movements are prepared with the affected hand during a dual-hand performance task .


These findings confirm behavioural observations , advance our insights on the neural substrate of DD and have implications for therapy .


Patients with Parkinson 's disease ( PD ) are at high risk for cognitive dysfunction .


Non-pharmacological interventions have attracted increasing interest for enhancing PD patients ' cognitive functions .


One-year follow-up data ( T2 ) of a randomized controlled trial evaluating two 6-week cognitive trainings - a structured ( NEUROvitalis , NV ) and an unstructured ( mentally fit , MF ) program - compared with a waiting list control group ( CG ) in non-demented PD patients ( Hoehn and Yahr I-III ) are presented .


Forty-seven PD patients were examined at T2 .


Effects on overall cognitive functions ( Mini-Mental State Examination and DemTect ) were compared between all groups with repeated measurement analyses of variance .


A combined score of the percentage change value from baseline ( T0 ) to T2 was calculated to identify patients who retained or improved their cognitive state ( responders ) .


The risk of developing mild cognitive impairment ( MCI ) was analyzed .


Significant time treatment effects on overall cognitive functions were found for both training groups , each compared separately to the CG ( DemTect , P < 0.05 ) .


Nine patients ( 56.3 % ) of the NV group , seven ( 41.2 % ) of the MF group and three ( 21.4 % ) of the CG were responders .


Comparing NV to CG the odds ratio was 4.7 [ 95 % confidence interval ( 0.8 ; 33.3 ) ] , and comparing MF to CG it was 2.6 [ 95 % confidence interval ( 0.4 ; 17.4 ) ] .


MCI risk for patients without prior MCI was 40.0 % in CG , 18.2 % in MF and 18.2 % in NV .


The odds ratio was 3 comparing NV to CG , MF to CG .


This study gives evidence that cognitive training may be effective to prevent cognitive decline and onset of MCI in PD patients .


The extended-release formulation of quetiapine ( quetiapine XR ) , which was developed to provide more convenient once-daily administration , has been widely studied to characterize its pharmacokinetics in Caucasian populations but has rarely been studied in an Asia population .


This study was conducted to evaluate the pharmacokinetics and tolerability of quetiapine XR administered as a single dose ( 300 mg ) and multiple doses ( 300 , 600 , and 800 mg ) in Han Chinese patients with schizophrenia .


This was a single-center , open-label , single-dose and multiple-dose randomized study .


Among the 55 randomized subjects , a total of 40 female or male patients in 300 mg ( n = 13 ) , 600 mg ( n = 13 ) , or 800 mg ( n = 14 ) groups completed the study of quetiapine fumarate XR .


The treatment phase consisted of 5 consecutive days and was preceded by a 1 - to 2-day titration period for the 600 and 800 mg groups .


Pharmacokinetic parameters for both quetiapine and N-desalkyl quetiapine ( norquetiapine ) were determined .


The tolerability evaluation included adverse events ( AEs ) noted by monitoring , physical examinations , vital signs , and clinical laboratory tests .


N-desalkyl quetiapine was formed from quetiapine with an approximate metabolite to parent ratio of 0.5 across the three dose groups .


The geometric mean elimination half-life ( t ) of both quetiapine and N-desalkyl quetiapine was consistent for the three dosing groups ( approximately 7 h for quetiapine and approximately 18 h for N-desalkyl quetiapine ) .


The geometric mean maximum plasma concentrations ( C max ) at steady state ( C max , ss ) of quetiapine for the three groups were 467 , 740 , and 1,126 ng/mL , respectively , and for N-desalkyl quetiapine were 138 , 262 , and 426 ng/mL , respectively .


The values for the geometric mean area under the plasma concentration-time curve over a dosing interval at the steady-state ( AUCss ) of quetiapine were 5,094 , 7,685 , and 13,237 ngh/mL , respectively , and for N-desalkyl quetiapine were 2,284 , 4,341 , and 7,216 ngh/mL , respectively .


The apparent oral clearance ( CL/F ) of quetiapine at steady state appeared to be comparable across the three dose groups .


The pharmacokinetics of quetiapine XR were dose-proportional across the dosage range employed .


The most common AE was somnolence , but all of the reported AEs were mild .


There were no serious AEs or other significant AEs .


Quetiapine fumarate XR has a dose-proportional pharmacokinetic profile at doses ranging from 300 to 800 mg once daily , and a slower time to reach C max and steady state after 3 days of sequential dosing .


Therefore , it offers a simple and rapid dose-escalation option and more convenient once-daily administration .


The three dosages of quetiapine fumarate XR were generally well-tolerated in this pharmacokinetic study of Han Chinese patients with schizophrenia .


Although low-fluence 1064-nm Q-switched Nd : YAG laser ( QSNYL ) is widely used for the treatment of melasma , multiple treatments are necessary for clinical improvement .


Superficial chemical peeling using Jessner 's solution has been used for treatment of melasma conventionally .


To evaluate the additional therapeutic effect and adverse effects of Jessner 's peel when combined with 1064-nm QSNYL for melasma patients in a double-blind , placebo-controlled design .


Total of 52 patients were included .


Patients who received 10 sessions of 1064-nm QSNYL plus chemical peeling with placebo ( group A ) in a two-week interval and those who received 10 sessions of 1064-nm QSNYL plus chemical peeling with Jessner 's solution ( group B ) in a two-week interval were analyzed .


Responses were evaluated using the Melasma Area and Severity Index ( MASI ) score , physician 's global assessment ( PGA ) and subjective self-assessment .


At 8 weeks , the mean MASI score decreased from 8.684.06 to 8.603.88 in group A and from 8.983.72 to 7.132.57 in group B , showing a significant difference ( p < 0.001 ) .


But at 20 weeks , there was no significant difference on reduction of MASI , self-assessment and PGA between the two groups .


No serious adverse effects were reported with the additional Jessner 's peeling .


This study suggests Jessner 's peel is a safe and effective method in the early course of treatment for melasma when combined with low-fluence 1064-nm Q-switched Nd : YAG laser .


To evaluate the potential body weight-lowering effects of dietary supplementation with eicosapentaenoic acid ( EPA ) and - lipoic acid separately or combined in healthy overweight/obese women following a hypocaloric diet .


This is a short-term double-blind placebo-controlled study with parallel design that lasted 10 weeks .


Of the randomized participants , 97 women received the allocated treatment [ Control , EPA ( 1.3 g/d ) , - lipoic acid ( 0.3 g/d ) , and EPA + - lipoic acid ( 1.3 g/d +0.3 g/d ) ] , and 77 volunteers completed the study .


All groups followed an energy-restricted diet of 30 % less than total energy expenditure .


Body weight , anthropometric measurements , body composition , resting energy expenditure , blood pressure , serum glucose , and insulin and lipid profile , as well as leptin and ghrelin levels , were assessed at baseline and after nutritional intervention .


Body weight loss was significantly higher ( P < 0.05 ) in those groups supplemented with - lipoic acid .


EPA supplementation significantly attenuated ( P < 0.001 ) the decrease in leptin levels that occurs during weight loss .


Body weight loss improved lipid and glucose metabolism parameters but without significant differences between groups .


The intervention suggests that - lipoic acid supplementation alone or in combination with EPA may help to promote body weight loss in healthy overweight/obese women following energy-restricted diets .


Cross-sectional .


To preliminarily evaluate the validity of an interview-based spinal cord injury ( SCI ) neuropathic pain screening instrument .


Six university-based SCI centers in the United States .


Clinician diagnoses of neuropathic pain ( NP ) and non-neuropathic pain subtypes were collected independently of descriptions of the pain characteristics provided by the persons with SCI by using the Spinal Cord Injury Pain Instrument ( SCIPI ) ; SCIPI information and physician diagnoses for 82 pain sites of which they were most confident were subsequently compared .


Four of the SCIPI items correlated significantly with the NP subtype as determined by the clinician .


The best cutoff score for identifying NP was an endorsement of two or more of these four items .


Using this cutoff , sensitivity of the SCIPI was 78 % , specificity was 73 % and overall diagnostic accuracy was 76 % .


In this preliminary study , the SCIPI , which can be administered by a nonclinician , appears to have good sensitivity , specificity and diagnostic accuracy in a SCI population ; it may have a role as a screening tool for NP after SCI .


Further study is needed .


Stepped care is recommended and implemented as a means to organise depression treatment .


Compared with alternative systems , it is assumed to achieve equivalent clinical effects and greater efficiency .


However , no trials have examined these assumptions .


A fully powered trial of stepped care compared with intensive psychological therapy is required but a number of methodological and procedural uncertainties associated with the conduct of a large trial need to be addressed first .


STEPS ( Developing stepped care treatment for depression ) is a mixed methods study to address uncertainties associated with a large-scale evaluation of stepped care compared with high-intensity psychological therapy alone for the treatment of depression .


We will conduct a pilot randomised controlled trial with an embedded process study .


Quantitative trial data on recruitment , retention and the pathway of patients through treatment will be used to assess feasibility .


Outcome data on the effects of stepped care compared with high-intensity therapy alone will inform a sample size calculation for a definitive trial .


Qualitative interviews will be undertaken to explore what people think of our trial methods and procedures and the stepped care intervention .


A minimum of 60 patients with Major Depressive Disorder will be recruited from an Improving Access to Psychological Therapies service and randomly allocated to receive stepped care or intensive psychological therapy alone .


All treatments will be delivered at clinic facilities within the University of Exeter .


Quantitative patient-related data on depressive symptoms , worry and anxiety and quality of life will be collected at baseline and 6 months .


The pilot trial and interviews will be undertaken concurrently .


Quantitative and qualitative data will be analysed separately and then integrated .


The outcomes of this study will inform the design of a fully powered randomised controlled trial to evaluate the effectiveness and efficiency of stepped care .


Qualitative data on stepped care will be of immediate interest to patients , clinicians , service managers , policy makers and guideline developers .


A more informed understanding of the feasibility of a large trial will be obtained than would be possible from a purely quantitative ( or qualitative ) design .


Current Controlled Trials ISRCTN66346646 registered on 2 July 2014 .


The overuse of antimicrobials is recognized as the main selective pressure driving the emergence and spread of antimicrobial resistance in human bacterial pathogens .


Urinary tract infections ( UTIs ) are among the most common infections presented in primary care and empirical antimicrobial treatment is currently recommended .


Previous research has identified that a substantial proportion of Irish general practitioners ( GPs ) prescribe antimicrobials for UTIs that are not in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland .


The aim of this trial is to design , implement and evaluate the effectiveness of a complex intervention on GP antimicrobial prescribing and adult ( 18 years of age and over ) patients ' antimicrobial consumption when presenting with a suspected UTI .


The Supporting the Improvement and Management of Prescribing for urinary tract infections ( SIMPle ) study is a three-armed intervention with practice-level randomization .


Adult patients presenting with suspected UTIs in primary care will be included in the study.The intervention integrates components for both GPs and patients .


For GPs the intervention includes interactive workshops , audit and feedback reports and automated electronic prompts summarizing recommended first-line antimicrobial treatment and , for one intervention arm , a recommendation to consider delayed antimicrobial treatment .


For patients , multimedia applications and information leaflets are included .


Thirty practices will be recruited to the study ; laboratory data indicate that 2,038 patients will be prescribed an antimicrobial in the study .


The primary outcome is a change in prescribing of first-line antimicrobials for UTIs in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland .


The study will take place over 15 months with a six-month intervention period .


Data will be collected through a remote electronic anonymized data-extraction system , a text-messaging system and GP and patient interviews and surveys .


The intervention will be strengthened by the implementation of a social marketing framework and an economic evaluation .


This intervention is registered at ClinicalTrials.gov , ID NCT01913860 .


Among young children in Burkina Faso , anemia and chronic and acute undernutrition are widespread .


This study assessed the impact of Helen Keller International 's ( HKI ) 2-y integrated agriculture [ homestead food production ( HFP ) ] and nutrition and health behavior change communication ( BCC ) program , targeted to women , on children 's ( 3-12 .9 mo old at baseline ) anthropometry ( stunting , wasting , and underweight ) , mean hemoglobin ( Hb ) , anemia ( Hb < 11 g/dL ) , and diarrhea prevalence .


We used a cluster-randomized controlled trial , with 55 villages randomly assigned to a control group ( n = 25 ) or 1 of 2 treatment groups ( n = 15 each ) , which differed by who delivered the BCC messages [ older women leaders or health committee ( HC ) members ] .


We used difference-in-difference ( DID ) estimates to assess impacts on child outcomes .


We found marginally significant ( P < 0.10 ) impacts on Hb ( DID : 0.51 g/dL ; P = 0.07 ) and wasting [ DID : -8.8 percentage point ( pp ) ; P = 0.08 ] and statistically significant ( P < 0.05 ) impacts on diarrhea ( -15.9 pp ; P = 0.00 ) in HC compared with control villages among children aged 3-12 .9 mo and larger impacts for anemia ( DID : -14.6 pp ; P = 0.03 ) and mean Hb ( DID : 0.74 g/dL ; P = 0.03 ) among younger children ( aged 3-5 .9 mo ) .


However , we found no significant impacts on stunting or underweight prevalence .


Plausibility was supported by greater improvements in women 's agricultural production and maternal infant and young child feeding and care knowledge and practices in HC compared with control villages .


HKI 's 2-y integrated HFP+BCC program ( HC group ) significantly improved several child outcomes , including wasting ( marginal ) , diarrhea , Hb , and anemia , especially among the youngest children .


This is the first cluster-randomized controlled trial of an HFP program that documents statistically significant positive effects on these child nutrition outcomes .


This trial was registered at clinicaltrials.gov as NCT01825226 .


Occipital nerve stimulation ( ONS ) may provide pain relief in migraine patients .


In this double-blinded trial we investigated the significance of paresthesia and possible placebo effects .


Patients already treated with ONS reporting stable treatment effect were included .


`` Effective stimulation , '' `` subthreshold stimulation '' and `` no stimulation '' were compared .


Patients cycled through all three treatment groups .


Outcome was measured using the visual analog scale ( VAS ) for pain , McGill Pain Questionnaire and SF-36 .


Eight patients were included , mean preoperative VAS was 8.20 1.22 .


A significant improvement in pain was observed in favor of suprathreshold stimulation compared to subthreshold stimulation ( 1.98 1.56 vs 5.65 2.11 ) .


Pain also significantly improved under subthreshold stimulation compared to no stimulation ( 5.65 2.11 vs 8.45 0.99 ) .


No changes in SF-36 were observed .


Paresthesia is not required to achieve pain reduction but suprathreshold stimulation yields better results , underlining the significance of stimulation parameter customization .


To determine the relationship between delayed patchy choroidal filling and morphologic and functional outcomes among eyes treated with ranibizumab or bevacizumab .


Cohort study .


Comparison of Age-related Macular Degeneration Treatment Trials participants were assigned randomly to ranibizumab or bevacizumab on a monthly or as-needed schedule .


Presence of delayed patchy choroidal filling and morphologic and functional outcomes were evaluated among eyes with gradable fluorescein angiography at baseline ( n = 973 ) and at 1 year ( n = 860 ) eyes .


Delayed filling was present in 75 ( 7.7 % ) of 973 eyes at baseline .


Eyes with incident delayed filling at 1 year ( 23 [ 2.9 % ] of 798 ) showed a mean decrease of 1.7 letters in visual acuity , whereas eyes without incident delayed filling had a mean improvement of 8.1 letters ( difference [ ] , -9.8 ; 95 % confidence interval [ CI ] , -15.8 to -3.9 ; P < .01 ) .


Eyes with incident delayed filling had a larger increase in mean total lesion area of choroidal neovascularization ( 3.00 mm ( 2 ) ) than eyes without incident delayed filling ( 0.56 mm ( 2 ) ; , 2.4 ; 95 % CI , 0.4 to 4.4 ; P = .02 ) .


The proportion with incident delayed filling at 1 year was similar among eyes treated with ranibizumab ( 10 [ 2.4 % ] of 413 ) or bevacizumab ( 13 [ 3.3 % ] of 385 ; P = .53 ) and among eyes treated monthly ( 12 [ 3.1 % ] of 388 ) or as needed ( 11 [ 2.7 % ] of 410 ; P = .83 ) .


Delayed patchy choroidal filling was uncommon at baseline .


Although only a small percentage of eyes demonstrated delayed filling during the first year of anti-vascular endothelial growth factor treatment , these eyes had worse visual acuity and a larger increase in total lesion area of choroidal neovascularization .


AVI-7288 is a phosphorodiamidate morpholino oligomer with positive charges that targets the viral messenger RNA that encodes Marburg virus ( MARV ) nucleoprotein .


Its safety in humans is undetermined .


We assessed the efficacy of AVI-7288 in a series of studies involving a lethal challenge with MARV in nonhuman primates .


The safety of AVI-7288 was evaluated in a randomized , multiple-ascending-dose study in which 40 healthy humans ( 8 humans per dose group ) received 14 once-daily infusions of AVI-7288 ( 1 mg , 4 mg , 8 mg , 12 mg , or 16 mg per kilogram of body weight ) or placebo , in a 3:1 ratio .


We estimated the protective dose in humans by comparing pharmacokinetic variables in infected nonhuman primates , uninfected nonhuman primates , and uninfected humans .


Survival in infected nonhuman primates was dose-dependent , with survival rates of 0 % , 30 % , 59 % , 87 % , 100 % , and 100 % among monkeys treated with 0 mg , 3.75 mg , 7.5 mg , 15 mg , 20 mg , and 30 mg of AVI-7288 per kilogram , respectively ( P < 0.001 with the use of the log-rank test for the comparison of survival across groups ) .


No safety concern was identified at doses up to 16 mg per kilogram per day in humans .


No serious adverse events were reported .


Drug exposure ( the area under the curve ) was dose-dependent in both nonhuman primates and humans ; drug clearance was independent of dose but was higher in nonhuman primates than in humans .


The protective dose in humans was initially estimated , on the basis of exposure , to be 9.6 mg per kilogram per day ( 95 % confidence interval , 6.6 to 12.5 ) for 14 days .


Monte Carlo simulations supported a dose of 11 mg per kilogram per day to match the geometric mean protective exposure in nonhuman primates .


This study shows that , on the basis of efficacy in nonhuman primates and pharmacokinetic data in humans , AVI-7288 has potential as postexposure prophylaxis for MARV infection in humans .


( Funded by the Department of Defense ; ClinicalTrials.gov number , NCT01566877 . )


Better understanding of the circumstances of alcohol-related adverse events experienced by university students could identify opportunities for prevention .


We aimed to identify situational and contextual factors associated with unintentional injury , assault , unsafe sex , sexual assault and drink-driving/riding amongst university students .


We conducted a Web-based survey of full-time students aged 17-25 years at five New Zealand universities ( n = 2683 ) and carried out between - and within-subjects comparisons ( case-control and case-crossover , respectively ) of situational and contextual characteristics of events in the last seven days and control drinking occasions .


The response fraction was 49 % .


For the seven days preceding the survey , 4.9 % of women and 7.4 % of men reported at least one of the defined events while they were drinking or soon after .


The number of drinking locations and getting drunker than expected were strongly associated with risk of an event in both case-control and case-crossover models , independent of consumption .


Total number of drinks , drinking later and into the morning , and drinking with close friends were also associated with increased risk in the case-control analysis .


No gender difference was seen after controlling for drinking and contextual factors .


Strategies to reduce the duration and volume of alcohol consumption , including earlier closing of licensed premises , should be considered as countermeasures for alcohol-related adverse events .


The use of two different comparison groups for the circumstances of adverse events when drinking can strengthen inferences about the contribution of contextual factors .


While the 2-adrenoceptor pathway is essential for cardiovascular regulation , the impact of ADRB2 gene variations on circulatory responses is unclear , possibly due to neural compensatory mechanisms .


We tested the hypotheses that ( i ) sympathetic block by thoracic epidural anaesthesia ( TEA ) unmasks the influence on arterial pressure of genetic variations and ( ii ) vasopressor requirements during TEA depend on ADRB2 gene variation .


Ninety-three elective patients undergoing abdominal surgery were included prospectively .


After epidural bupivacaine 0.5 % ( 15 mg test dose +50 mg ) , arterial pressure , heart rate , and progression of sensory block were measured for 20 min in the supine awake state and for 20 min after standardized anaesthetic induction of general anaesthesia .


The primary endpoint was cumulative dose of the - adrenoreceptor agonist phenylephrine administered to sustain a mean arterial pressure > 70 mm Hg .


The ADRB2 polymorphisms Arg16Gly and Gln27Glu were genotyped using Slowdown-PCR .


After TEA , 86 ( 93 % ) patients required phenylephrine .


The mean dosages ( sd ) were significantly different between the ADRB2 genotypes [ Arg16Arg 357 g ( 326 ) , Arg16Gly 776 g ( 449 ) , Gly16Gly 600 g ( 443 ) , P = 0.036 ; Gln27Gln 356 g ( 254 ) , Gln27Glu 639 g ( 354 ) , Glu27Glu 577 g ( 388 ) , P = 0.007 ] .


Multiple linear regression analysis revealed that age , male gender , rostral extent of sensory block , lower arterial pressure before TEA , and ADRB2 Glu27 allele together explained 37 % of phenylephrine dosage variation , with genetic variants being the second most important predictor ( 10 % ; P < 0.001 ) .


The ADRB2 Glu27 allele is an independent predictor of arterial hypotension and vasopressor requirements after TEA .


Neural block can unmask genetic influences on neurohumoral regulation .


Clinical trial registration DRKS00005260 .


Patient-centered models of assessment have shown considerable promise for increasing patients ' readiness for mental health treatment in general , but have not been used to facilitate patients ' engagement in substance use disorder ( SUD ) treatment .


We developed a brief patient-centered intervention using assessment and feedback of personality data and examined its acceptability and efficacy to increase early engagement in residential SUD treatment .


Thirty patients entering a 90-day residential SUD treatment program were randomly assigned to a feedback ( n = 17 ) or control ( n = 13 ; assessment-only ) condition .


Normal-range personality was assessed with the NEO Personality Inventory-Revised ( NEO PI-R ) .


Patients were re-interviewed one month after treatment entry to obtain information on their satisfaction with the intervention , as well as their adjustment to the residential milieu .


Electronic medical records were reviewed to obtain information on patients ' length of stay in the program and discharge status .


Univariate ANOVAs and chi-square tests were conducted to examine group differences on outcomes .


Patients ' ratings indicated strong satisfaction with the feedback intervention and expectations that it would have a positive impact on their treatment experiences .


Among patients who had not previously been treated in the residential program , the feedback intervention was associated with more positive relationships with other residents in treatment and a stronger alliance with the treatment program one month after treatment entry .


The feedback intervention was also associated with a longer length of stay in treatment , although this effect did not reach statistical significance .


The findings highlight the clinical utility of providing SUD patients with patient-centered feedback based on the results of personality testing , and provide preliminary support for the acceptability and efficacy of this intervention to facilitate early engagement in residential SUD treatment .


In children with single right ventricular ( RV ) anomalies , changes in RV size and function may beinfluenced by shunt type chosen at the time of the Norwood procedure .


The study sought to identify shunt-related differences in echocardiographic findings at 14 months and6months pre-Fontan in survivors of the Norwood procedure .


We compared 2-dimensional and Doppler echocardiographic indices of RV size and function , neo-aortic and tricuspid valve annulus dimensions and function , and aortic size and patency at 14.1 1.2 months and 33.6 9.6 months in subjects randomized to a Norwood procedure using either the modified Blalock-Taussig shunt ( MBTS ) or right ventricle to pulmonary artery shunt ( RVPAS ) .


Acceptable echocardiograms were available at both time points in 240 subjects ( 114 MBTS , 126 RVPAS ) .


At 14 months , all indices were similar between shunt groups .


From the 14-month to pre-Fontan echocardiogram , the MBTS group had stable indexed RV volumes and ejection fraction , while the RVPAS group had increased RV end-systolic volume ( p = 0.004 ) and decreased right ventricular ejection fraction ( RVEF ) ( p = 0.004 ) .


From 14 months to pre-Fontan , the treatment groups were similar with respect to decline in indexed neo-aortic valve area , > mild neo-aortic valve regurgitation ( < 5 % at each time ) , indexed tricuspid valve area , andmoderate tricuspid valve regurgitation ( < 20 % at each time ) .


Initial Norwood shunt type influences pre-Fontan RV remodeling during the second and third years of life in survivors with single RV anomalies , with greater RVEF deterioration after RVPAS .


Encouragingly , other indices of RV function remain stable before Fontan regardless of shunt type .


( Comparison of Two Types of Shunts in Infants with Single Ventricle Defect Undergoing Staged Reconstruction-Pediatric Heart Network ; NCT00115934 ) .


The aim of the study was to compare Cistiquer , a new phytotherapeutic product developed for chronic bladder inflammatory diseases , and intra-vesical administration of gentamicin plus betametasone , in females with urethral syndrome .


Between september 2013 and may 2014 , 60 women with urethral syndrome and trigonitis were incuded in this study .


Patients were randomly assigned to treatment with intra-vesical administration of betametasone 8 mg plus gentamicin 80 mg ( group A ) , and oral administration of Cistiquer ( group B ) for 7 weeks .


Before and after the therapeutic protocol , symptoms were assessed by three days voiding diary , the overactive bladder questionnaire short form and a ten points visual analogic scale adopted to assess the micturition discomfort .


Histologic findings were assessed by the examination of specimens obtained by cold bladder biopsies of the bladder trigone at baseline in all the subjects .


The two groups had significant and comparable symptoms improvement .


However , the score obtained from the visual analogic scale decreased significantly only in the group submitted to oral therapy .


Furthermore , in the group treated with endovesical approach , higher drop out rate and higher incidence of urinary infection were observed .


Patients with urethral syndrome and trigonitis improved symptoms either with oral therapy with Cistiquer and with intra-vesical administration of gentamicin plus betametasone .


However , treatment adherence resulted higher for patients treated by oral therapy and rate of adverse events resulted higher for those submitted to endovesical treatment .


To evaluate the cardiorespiratory , sedative and antinociceptive effects of dexmedetomidine alone or in combination with methadone , morphine or tramadol in dogs .