Department of Biotechnology and the Biotechnology Industry Research Assistance Council , Government of India ; Bill & Melinda Gates Foundation to PATH , USA ; Research Council of Norway ; UK Department for International Development ; National Institutes of Health , Bethesda , USA ; and Bharat Biotech International , Hyderabad , India .


This study sought to assess the feasibility of conducting a phase III HIV prevention trial using a multivalent human papillomavirus ( HPV ) vaccine ( Gardasil ; Merck , Whitehouse Station , NJ ) .


A total of 479 sexually active women aged 16-24 years in the Western Cape , South Africa , were enrolled in the Efficacy of HPV Vaccine to Reduce HIV Infection ( EVRI ) Trial .


Of these , 402 were HIV negative , nonpregnant , and randomized 1:1 to receive Gardasil or a saline placebo vaccine .


Vaccine doses were administered at enrollment , month 2 , and month 6 , and participants were followed for 1 month after the third dose .


Enrollment HIV , HPV , other sexually transmitted infections ( STIs ) , and cervical cytology were evaluated .


Rates of accrual , vaccine compliance , and adherence to protocol were monitored .


High rates of accrual of eligible females to study ( 93 % ) and completion of the 3-dose vaccine series ( 91 % ) were noted , with few protocol violations .


Ineligibility due to reported HIV positivity was 19 % , and another 12 % of those enrolled tested HIV positive .


STI prevalence was high , with 6.2 % , 10.9 % , and 32.8 % testing positive for syphilis , gonorrhea , and chlamydia , respectively .


Cervical prevalence of 1 of 37 HPV types was 71 % .


STI and HPV prevalence was highest among the youngest women ( < 19 years ) .


Feasibility ( successful accrual , retention , and vaccination ) of conducting randomized placebo-controlled trials of HPV vaccines among HIV high-risk women in South Africa was demonstrated .


This work demonstrates that phase III HIV prevention trials need to intervene at young ages and screen and treat multiple STIs concurrently to have a measurable impact on HIV acquisition .


To evaluate whether automated reminders increase on-time completion of the three-dose human papillomavirus ( HPV ) vaccine series .


Ten reproductive health centers enrolled 365 women aged 19-26 to receive dose one of the HPV vaccine .


Health centers were matched and randomized so that participants received either routine follow-up ( control ) or automated reminder messages for vaccine doses two and three ( intervention ) .


Intervention participants selected their preferred method of reminders - text , e-mail , phone , private Facebook message , or standard mail .


We compared vaccine completion rates between groups over a period of 32 weeks .


The reminder system did not increase completion rates , which overall were low at 17.2 % in the intervention group and 18.9 % in the control group ( p = 0.881 ) .


Exploratory analyses revealed that participants who completed the series on-time were more likely to be older ( OR = 1.15 , 95 % CI 1.01-1 .31 ) , report having completed a four-year college degree or more ( age-adjusted OR = 2.51 , 95 % CI 1.29-4 .90 ) , and report three or more lifetime sexual partners ( age-adjusted OR = 3.45 , 95 % CI 1.20-9 .92 ) .


The study intervention did not increase HPV vaccine series completion .


Despite great public health interest in HPV vaccine completion and reminder technologies , completion rates remain low .


To assess efavirenz plasma concentrations and their association with treatment efficacy and tolerance of efavirenz 600 mg daily in HIV-tuberculosis co-infected patients .


HIV-infected adults with CD4 + T cell count 200/mm ( 3 ) received standard 6-month tuberculosis treatment and antiretroviral therapy including a daily-dose of 600 mg of efavirenz , irrespective of their body weight .


Mid-dose blood samples were drawn both on tuberculosis treatment ( week +2 and week +6 after antiretroviral therapy initiation , and week 22 of follow-up ) and off tuberculosis treatment ( week 50 of follow-up ) .


Considered therapeutic range was 1,000 to 4,000 ng/mL .


Multivariate analysis was performed to evaluate the association between efavirenz concentration below 1,000 ng/mL and virological failure .


Linear regression was used to test the association between efavirenz exposure and CD4 + T cell gain .


Severe side effects potentially related to efavirenz were described and their association with efavirenz exposure was tested by multivariate analysis .


Efavirenz plasma concentrations were available in 540 patients .


Median [ interquartile range ] efavirenz concentrations were 2,674 ng/mL [ 1,690-4 ,533 ] , 2,667 ng/mL [ 1,753-4 ,494 ] and 2,799 ng/mL [ 1,804-4 ,744 ] at week +2 , week +6 , week 22 , respectively , and 2,766 ng/mL [ 1,941-3 ,976 ] at week 50 .


Efavirenz concentrations were lower at week 50 ( off rifampicin ) compared to week 22 ( on rifampicin ) ( p < 0.001 ) .


Late attendance to study visit and low hemoglobinemia were the only factors associated with an increased risk of efavirenz concentration below 1,000 ng/mL .


Efavirenz concentration below 1,000 ng/mL was not associated with treatment failure .


Efavirenz concentration above 4,000 ng/mL was associated with higher risk of central nervous system side effects ( p < 0.001 ) and of hepatotoxicity ( p < 0.001 ) .


Body weight and tuberculosis treatment were not associated with low efavirenz concentrations or treatment failure , supporting the 600 mg daily-dose of efavirenz in HIV-tuberculosis co-infected patients .


High efavirenz concentrations were related to a higher risk of central nervous system side effects and hepatotoxicity .


ClinicalTrials.gov NCT01300481 .


Pisa syndrome ( PS ) is a tonic lateral flexion of trunk that represents a disabling complication of advanced Parkinson disease ( PD ) .


Conventional rehabilitation treatment ( CT ) ameliorates axial posture and trunk mobility in PD patients , but the improvement tends to wane in 4-6 months .


Botulin toxin ( BT ) may reduce muscle hyperactivity , therefore improving CT effectiveness .


We evaluated whether the injection of incabotulinum toxin type A ( iBTA ) into the hyperactive trunk muscles might improve the effectiveness of rehabilitation in a group of PD patients with PS .


Twenty-six PD patients were enrolled in a randomized placebo-controlled trial .


Group A was treated with iBTA before undergoing CT ( a 4-week intensive programme ) , while Group B received saline before the 4-week CT treatment .


Patients were evaluated at baseline , at the end of the rehabilitative period , 3 and 6 months with kinematic analysis of movement , UPDRS , Functional Independence Measure and Visual Analog Scale for pain .


At the end of the rehabilitation period , both groups improved significantly in terms of static postural alignment and of range of motion .


Group A showed a significantly more marked reduction in pain score as compared with Group B and a more prolonged efficacy on several clinical and kinematic variables .


Our preliminary data suggest that BT may be considered an important addition to the rehabilitation programme for PD subjects with PS for improving axial posture and trunk mobility , as well as for a better control of pain .


The optimal perioperative fluid resuscitation strategy for liver resections remains undefined .


Goal-directed therapy ( GDT ) embodies a number of physiologic strategies to achieve an ideal fluid balance and avoid the consequences of over - or under-resuscitation .


In a prospective randomized trial , patients undergoing liver resection were randomized to GDT using stroke volume variation as an end point or to standard perioperative resuscitation .


Primary outcomes measure was 30-day morbidity .


Between 2012 and 2014 , one hundred and thirty-five patients were randomized ( GDT : n = 69 ; standard perioperative resuscitation : n = 66 ) .


Median age was 57 years and 56 % were male .


Metastatic disease comprised 81 % of patients .


Overall ( 35 % GDT vs 36 % standard perioperative resuscitation ; p = 0.86 ) and grade 3 morbidity ( 28 % GDT vs 18 % standard perioperative resuscitation ; p = 0.22 ) were equivalent .


Patients in the GDT arm received less intraoperative fluid ( mean 2.0 L GDT vs 2.9 L standard perioperative resuscitation ; p < 0.001 ) .


Perioperative transfusions were required in 4 % ( 6 % GDT vs 2 % standard perioperative resuscitation ; p = 0.37 ) and boluses in the postanesthesia care unit were administered to 24 % ( 29 % GDT vs 20 % standard perioperative resuscitation ; p = 0.23 ) .


Mortality rate was 1 % ( 2 of 135 patients ; both in GDT ) .


On multivariable analysis , male sex , age , combined procedures , higher intraoperative fluid volume , and fluid boluses in the postanesthesia care unit were associated with higher 30-day morbidity .


Stroke volume variation-guided GDT is safe in patients undergoing liver resection and led to less intraoperative fluid .


Although the incidence of postoperative complications was similar in both arms , lower intraoperative resuscitation volume was independently associated with decreased postoperative morbidity in the entire cohort .


Future studies should target extensive resections and identify patients receiving large resuscitation volumes , as this population is more likely to benefit from this technique .


Highly pathogenic avian influenza A ( H5N1 ) causes severe infections in humans .


We generated 2 influenza A ( H5N1 ) live attenuated influenza vaccines for pandemic use ( pLAIVs ) , but they failed to elicit a primary immune response .


Our objective was to determine whether the vaccines primed or established long-lasting immunity that could be detected by administration of inactivated subvirion influenza A ( H5N1 ) vaccine ( ISIV ) .


The following groups were invited to participate in the study : persons who previously received influenza A ( H5N1 ) pLAIV ; persons who previously received an irrelevant influenza A ( H7N3 ) pLAIV ; and community members who were naive to influenza A ( H5N1 ) and LAIV .


LAIV-experienced subjects received a single 45-g dose of influenza A ( H5N1 ) ISIV .


Influenza A ( H5N1 ) - and LAIV-naive subjects received either 1 or 2 doses of ISIV .


In subjects who had previously received antigenically matched influenza A ( H5N1 ) pLAIV followed by 1 dose of ISIV compared with those who were naive to influenza A ( H5N1 ) and LAIV and received 2 doses of ISIV , we observed an increased frequency of antibody response ( 82 % vs 50 % , by the hemagglutination inhibition assay ) and a significantly higher antibody titer ( 112 vs 76 ; P = .04 ) .


The affinity of antibody and breadth of cross-clade neutralization was also enhanced in influenza A ( H5N1 ) pLAIV-primed subjects .


ISIV administration unmasked long-lasting immunity in influenza A ( H5N1 ) pLAIV recipients , with a rapid , high-titer , high-quality antibody response that was broadly cross-reactive across several influenza A ( H5N1 ) clades .


NCT01109329 .


The aim of this prospective clinical study was to derive the absolute and relative costs of cone beam CT ( CBCT ) and panoramic imaging before removal of an impacted mandibular third molar .


Furthermore , the study aimed to analyse the influence of different cost-setting scenarios on the outcome of the absolute and relative costs and the incremental costs related to surgery .


A randomized clinical trial compared complications following surgical removal of a mandibular third molar , where the pre-operative diagnostic method had been panoramic imaging or CBCT .


The resources implied in the two methods were measured with health economic tools .


The primary outcome was total costs defined as the sum of absolute imaging costs and incremental surgery-related costs .


The basic variables were capital costs , operational costs , radiological costs , radiographic costs , overheads and patient resource utilization .


Differences in resources used for surgical and post-surgical management were calculated for each patient .


Converted to monetary units , the total costs for panoramic imaging equalized 49.29 and for CBCT examination 184.44 .


Modifying effects on this outcome such as differences in surgery time , treatment time for complications , pre - and post-surgical medication , sickness absence , specialist treatment and hospitalization were not statistically significant between the two diagnostic method groups .


Costs for a CBCT examination were approximately four times the costs for panoramic imaging when used prior to removal of a mandibular third molar .


The use of CBCT did not change the resources used for surgery , post-surgical treatment and patient complication management .


Conducted a randomized controlled trial to investigate the effectiveness of cognitive behavioral therapy ( CBT ) , and compared the relative effectiveness of individual ( ICBT ) and group ( GCBT ) treatment approaches for anxiety disorders in children and adolescents .


Referred youth ( N = 182 , M age = 11.5 years , range 8-15 years , 53 % girls ) with separation anxiety , social phobia , or generalized anxiety disorder were randomly assigned to ICBT , GCBT or a waitlist control ( WLC ) in community clinics .


Pre - , post - , and one year follow-up assessments included youth and parent completed diagnostic interview and symptom measures .


After comparing CBT ( ICBT and GCBT combined ) to WLC , ICBT and GCBT were compared along diagnostic recovery rates , clinically significant improvement , and symptom measures scores using traditional hypothesis tests , as well as statistical equivalence tests .


Significantly more youth lost all anxiety disorders after CBT compared to WLC .


Full diagnostic recovery rate was 25.3 % for ICBT and 20.5 % in GCBT , which was not significantly different .


There was continued lack of significant differences between ICBT and GCBT at one year follow-up .


However , equivalence between GCBT and ICBT could only be demonstrated for clinical severity rating of the principal anxiety disorder and child reported anxiety symptoms post-treatment .


Findings support the effectiveness of CBT compared to no intervention for youth with anxiety disorders , with no significant differences between ICBT and GCBT .


However , the relatively low recovery rates highlight the need for further improvement of CBT programs and their transportability from university to community settings .


To evaluate visual function and disease progression in the retinal structural abnormalities of three patients from two unrelated families with macular telangiectasia ( MacTel ) type 2 .


Adaptive optics scanning laser ophthalmoscopy ( AOSLO ) and AOSLO microperimetry ( AOMP ) were used to evaluate the structure and function of macular cones in three eyes with MacTel type 2 .


Cone spacing was estimated using histogram analysis of intercone distances , and registered spectral-domain optical coherence tomography ( SD-OCT ) scans were used to evaluate retinal anatomy .


AOMP was used to assess visual sensitivity in and around areas of apparent cone loss .


Although overall lesion surface area increased , some initially affected regions subsequently showed clear , contiguous , and normally spaced cone mosaics with recovered photoreceptor inner/outer segment ( IS/OS ) reflectivity ( two of two eyes ) .


The AOMP test sites fell within three categories : normal-appearing cones ( N ) , dimly reflecting cones ( D ) , and RPE cell mosaics ( R ) .


At N sites , AOMP threshold values ( arbitrary units [ au ] ) increased with increasing eccentricity ( slope = 0.054 au/degree , r ( 2 ) = 0.77 ) .


The N thresholds ranged from 0.04 to 0.27 au , D thresholds from 0.04 to 0.33 au , and R thresholds from 0.14 to 1.00 au .


There was measurable visual sensitivity everywhere except areas without intact external limiting membrane ( ELM ) and with diffuse scattering in the IS/OS and posterior tips of the outer segments ( PTOS ) regions on OCT. .


Visual sensitivity and recovery of cone visibility in areas of apparent focal cone loss suggests that MacTel type 2 lesions with a preserved ELM may contain functioning cones with abnormal scattering and/or waveguiding characteristics .


( ClinicalTrials.gov number , NCT00254605 . )


Cardiopulmonary resuscitation ( CPR ) performed by bystanders is associated with increased survival rates among persons with out-of-hospital cardiac arrest .


We investigated whether rates of bystander-initiated CPR could be increased with the use of a mobile-phone positioning system that could instantly locate mobile-phone users and dispatch lay volunteers who were trained in CPR to a patient nearby with out-of-hospital cardiac arrest .


We conducted a blinded , randomized , controlled trial in Stockholm from April 2012 through December 2013 .


A mobile-phone positioning system that was activated when ambulance , fire , and police services were dispatched was used to locate trained volunteers who were within 500 m of patients with out-of-hospital cardiac arrest ; volunteers were then dispatched to the patients ( the intervention group ) or not dispatched to them ( the control group ) .


The primary outcome was bystander-initiated CPR before the arrival of ambulance , fire , and police services .


A total of 5989 lay volunteers who were trained in CPR were recruited initially , and overall 9828 were recruited during the study .


The mobile-phone positioning system was activated in 667 out-of-hospital cardiac arrests : 46 % ( 306 patients ) in the intervention group and 54 % ( 361 patients ) in the control group .


The rate of bystander-initiated CPR was 62 % ( 188 of 305 patients ) in the intervention group and 48 % ( 172 of 360 patients ) in the control group ( absolute difference for intervention vs. control , 14 percentage points ; 95 % confidence interval , 6 to 21 ; P < 0.001 ) .


A mobile-phone positioning system to dispatch lay volunteers who were trained in CPR was associated with significantly increased rates of bystander-initiated CPR among persons with out-of-hospital cardiac arrest .


( Funded by the Swedish Heart-Lung Foundation and Stockholm County ; ClinicalTrials.gov number , NCT01789554 . )


To evaluate the in vivo effect of chewing gum containing allyl isothiocyanate alone , and in combination with zinc salts on reduction of the level of volatile sulfur compounds responsible for oral malodor .


15 healthy volunteers between the ages of 20-50 chewed either an experimental gum or a placebo gum for 12 minutes .


Their mouth air was analyzed for volatile sulfur compounds by a gas chromatograph at baseline , immediately after chewing , and at 60 , 120 and 180 minutes after treatment .


The study revealed that allyl isothiocyanate , a constituent of mustard seed extract , can effectively reduce the concentration of volatile sulfur compounds in mouth air .


Chewing gum containing 0.1 % zinc lactate and 0.01 % of allyl isothiocyanate eliminated 89 % , 55.5 % , 48 % and 24 % of the total VSC concentration immediately after chewing and at 1 , 2 , and 3 hours after chewing , respectively .


Recently , Marczinski and colleagues ( 2013 ) showed that energy drinks combined with alcohol augment a person 's desire to drink more alcohol relative to drinking alcohol alone .


The current study replicates the findings of Marczinski and colleagues ( 2013 ) using a robust measure of alcohol craving .


Seventy-five participants aged 18 to 30years were assigned to an alcohol only or alcohol + energy drink condition in a double-blind randomized pre - versus posttest experiment .


Participants received a cocktail containing either 60ml of vodka and a Red Bull ( ) Silver Edition energy drink ( alcohol + energy drink condition ) or 60ml of vodka with a soda water vehicle ( alcohol-only condition ) ; both cocktails contained 200ml of fruit drink .


The primary outcome measure was the Alcohol Urge Questionnaire taken at pretest and at 20minutes ( posttest ) .


Other measures taken at posttest were the Biphasic Alcohol Effects Questionnaire , the Drug Effects Questionnaire , and breath alcohol concentration ( BAC ) .


The alcohol + energy drink condition showed a greater pre - versus posttest increase in urge to drink alcohol compared with the alcohol-only condition ( B = 3.24 , p = 0.021 , d = 0.44 ) .


Participants in the alcohol + energy drink condition had significantly higher ratings on liking the cocktail and wanting to drink more of the cocktail , and lower BACs , than the alcohol-only condition .


When examined at specific BACs , the effect of the energy drink on the pre - to posttest increase in urge to drink was largest and only significant at BACs of 0.04-0 .05 ( cf. < 0.04 g/dl ) .


There were no significant differences in stimulation , sedation , feeling the effects of the cocktail , or feeling high .


Combining energy drinks with alcohol increased the urge to drink alcohol relative to drinking alcohol alone .


More research is needed to understand what factors mediate this effect and whether it increases subsequent alcohol consumption .


A significant correlation exists between coronary artery diseases and depression .


The aim of this trial was to compare the efficacy and safety of saffron versus fluoxetine in improving depressive symptoms of patients who were suffering from depression after performing percutaneous coronary intervention ( PCI ) .


In this randomized double-blind parallel-group study , 40 patients with a diagnosis of mild to moderate depression who had undergone PCI in the last six months were randomized to receive either fluoexetine ( 40mg/day ) or saffron ( 30mg/day ) capsule for six weeks .


Participants were evaluated by Hamilton depression rating scale ( HDRS ) at weeks 3 and 6 and the adverse events were systemically recorded .


By the study endpoint , no significant difference was detected between two groups in reduction of HDRS scores ( P = 0.62 ) .


Remission and response rates were not significantly different as well ( P = 1.00 and P = 0.67 ; respectively ) .


There was no significant difference between two groups in the frequency of adverse events during this trial .


Relatively small sample size and short observational period were the major limitations of this study .


Short-term therapy with saffron capsules showed the same antidepressant efficacy compared with fluoxetine in patients with a prior history of PCI who were suffering from depression .


Arthroscopic partial meniscectomy is one of the most common orthopedic procedures , yet rigorous evidence of its efficacy is lacking .


We conducted a multicenter , randomized , double-blind , sham-controlled trial in 146 patients 35 to 65 years of age who had knee symptoms consistent with a degenerative medial meniscus tear and no knee osteoarthritis .


Patients were randomly assigned to arthroscopic partial meniscectomy or sham surgery .


The primary outcomes were changes in the Lysholm and Western Ontario Meniscal Evaluation Tool ( WOMET ) scores ( each ranging from 0 to 100 , with lower scores indicating more severe symptoms ) and in knee pain after exercise ( rated on a scale from 0 to 10 , with 0 denoting no pain ) at 12 months after the procedure .


In the intention-to-treat analysis , there were no significant between-group differences in the change from baseline to 12 months in any primary outcome .


The mean changes ( improvements ) in the primary outcome measures were as follows : Lysholm score , 21.7 points in the partial-meniscectomy group as compared with 23.3 points in the sham-surgery group ( between-group difference , -1.6 points ; 95 % confidence interval [ CI ] , -7.2 to 4.0 ) ; WOMET score , 24.6 and 27.1 points , respectively ( between-group difference , -2.5 points ; 95 % CI , -9.2 to 4.1 ) ; and score for knee pain after exercise , 3.1 and 3.3 points , respectively ( between-group difference , -0.1 ; 95 % CI , -0.9 to 0.7 ) .


There were no significant differences between groups in the number of patients who required subsequent knee surgery ( two in the partial-meniscectomy group and five in the sham-surgery group ) or serious adverse events ( one and zero , respectively ) .


In this trial involving patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear , the outcomes after arthroscopic partial meniscectomy were no better than those after a sham surgical procedure .


( Funded by the Sigrid Juselius Foundation and others ; ClinicalTrials.gov number , NCT00549172 . )


Placebo effects have been reported in type I allergic reactions .


However the neuropsychological mechanisms steering placebo responses in allergies are largely unknown .


The study analyzed whether and to what extend a conditioned placebo response is affecting type I allergic reactions and whether this response can be reproduced at multiple occasions .


62 patients with house dust mite allergy were randomly allocated to either a conditioned ( n = 25 ) , sham-conditioned ( n = 25 ) or natural history ( n = 12 ) group .


During the learning phase ( acquisition ) , patients in the conditioned group received the H1-receptor antagonist desloratadine ( 5mg ) ( unconditioned stimulus/US ) together with a novel tasting gustatory stimulus ( conditioned stimulus/CS ) .


Patients in the sham-conditioned control group received the CS together with a placebo pill .


After a wash out time of 9 days patients in the conditioned and sham-conditioned group received placebo pills together with the CS during evocation .


Allergic responses documented by wheal size after skin prick test and symptom scores after nasal provocation were analyzed at baseline , after last desloratadine treatment and after the 1 ( st ) and 5 ( th ) CS re-exposure .


Both conditioned and sham-conditioned patients showed significantly decreased wheal sizes after the 1 ( st ) CS-evocation and significantly decreased symptom scores after the 1 ( st ) as well as after the 5 ( th ) evocation compared to the natural history control group .


These results indicate that placebo responses in type I allergy are not primarily mediated by learning processes , but seemed to be induced by cognitive factors such as patients ' expectation , with these effects not restricted to a single evocation .


Frequent skin cleaning fulfils the definition of occupational ` wet work ' .


Standardized methods are required to assess the irritation potential of workplace cleansers .


To develop a standardized procedure for testing the irritation potential of occupational skin cleansers .


In this single-blind , single-centre trial in 25 healthy volunteers , the irritation potential of five generic reference cleansers was tested by three-times-daily washing with an automated skin cleaning device for 4days , and quantification of cumulative skin barrier damage was performed by visual scoring , chromametry , transepidermal water loss TEWL , and corneometry .


For two cleansers , reproducibility of the irritancy assessment was assessed .


Furthermore , the irritation induced by four commercial workplace skin cleansers was studied .


Whereas no significant changes were observed for any of the tested cleansers by either visual scoring or chromametry , significant increases in TEWL and significant decreases in stratum corneum hydration were found for all cleansers .


Cleansers differed significantly in their irritation potential .


On retesting of two cleansers , the first results were confirmed .


Among the four commercial cleansers , one that was claimed to be mild was found to be disproportionally irritant .


The presented model for testing cleansing preparations allows a highly controlled , practically relevant and reproducible irritancy assessment of occupational skin cleansers .


The effects of brimonidine on daytime and nighttime intraocular pressure ( IOP ) and aqueous humor dynamics were evaluated in volunteers with ocular hypertension ( OHT ) .


Thirty participants with OHT ( 58.61.7 years old , meanSEM ) were enrolled into this randomized , double-masked , cross-over study .


For 6 weeks , participants self-administered 0.2 % brimonidine or placebo 3 times daily .


During daytime and nighttime visits , measurements included aqueous flow ( Fa ) by fluorophotometry , outflow facility ( C ) by tonography , episcleral venous pressure ( Pev ) by venomanometry , and seated and supine IOP by pneumatonometry .


Uveoscleral outflow ( U ) was calculated mathematically .


When treated with placebo , nighttime supine Pev ( 11.20.25 mm Hg ) was higher ( P < 0.05 ) compared with daytime seated Pev ( 10.20.25 mm Hg ) , and Fa and U were significantly reduced at night .


Brimonidine significantly lowered seated IOP at 9:00 AM and 11:00 AM , 9:00 PM and 11:00 PM and supine IOP at 9:00 AM and 11:00 AM .


Brimonidine increased U at 9 AM and 11 AM ( P < 0.01 ) and had no effect on daytime and nighttime Fa , C , or Pev .


In subjects with OHT , brimonidine treatment for 6 weeks significantly reduces seated IOP during the day by increasing uveoscleral outflow .


The lack of IOP effect at night can be explained by failure to overcome a normal nighttime reduction of uveoscleral outflow .


Pain is a negative factor in the recovery process of postoperative patients .


It causes pulmonary alterations and complications , and it also affects functional capacity .


Several studies have investigated the effects of transcutaneous electrical nerve stimulation ( TENS ) during the postoperative period .


However , no studies have assessed the effects of TENS on kidney donors .


Thus , the aim of the present study was to evaluate the effect of TENS on pain , walking function , respiratory muscle strength and vital capacity in kidney donors .


Seventy-four patients were randomly allocated into two groups : active TENS or placebo TENS .


All patients were assessed for pain intensity , respiratory muscle strength , vital capacity and walking function before and after the TENS application on the first day of the postoperative period .


The use of active TENS significantly reduced pain at rest ( p = 0.006 ) , during the measurement of maximal inspiratory pressure ( p = 0.006 ) , during maximal expiratory pressure ( p = 0.004 ) and during vital capacity ( p = 0.013 ) .


Active TENS also produced a significant increase in maximal expiratory pressure when compared with the placebo TENS group ( p = 0.001 ) .


Maximal inspiratory pressure , vital capacity and walking function were not significantly different between the two treatment groups .


These results suggest that TENS decreases pain intensity at rest and during respiratory manoeuvres and increases maximal expiratory pressure during the postoperative period in kidney donors after open nephrectomy .


To investigate the effect of systematic screening for risk factors for ischaemic heart disease followed by repeated lifestyle counselling on the 10 year development of ischaemic heart disease at a population level .


Randomised controlled community based trial .


Suburbs of Copenhagen , Denmark .


59,616 people aged 30-60 years randomised with different age and sex randomisation ratios to an intervention group ( n = 11,629 ) and a control group ( n = 47,987 ) .


The intervention group was invited for screening , risk assessment , and lifestyle counselling up to four times over a five year period .


All participants with an unhealthy lifestyle had individually tailored lifestyle counselling at all visits ( at baseline and after one and three years ) ; those at high risk of ischaemic heart disease , according to predefined criteria , were furthermore offered six sessions of group based lifestyle counselling on smoking cessation , diet , and physical activity .


After five years all were invited for a final counselling session .


Participants were referred to their general practitioner for medical treatment , if relevant .


The control group was not invited for screening .


The primary outcome measure was incidence of ischaemic heart disease in the intervention group compared with the control group .


Secondary outcome measures were stroke , combined events ( ischaemic heart disease , stroke , or both ) , and mortality .


6091 ( 52.4 % ) people in the intervention group participated at baseline .


Among 5978 people eligible at five year follow-up ( 59 died and 54 emigrated ) , 4028 ( 67.4 % ) attended .


A total of 3163 people died in the 10 year follow-up period .


Among 58,308 without a history of ischaemic heart disease at baseline , 2782 developed ischaemic heart disease .


Among 58,940 without a history of stroke at baseline , 1726 developed stroke .


No significant difference was seen between the intervention and control groups in the primary end point ( hazard ratio for ischaemic heart disease 1.03 , 95 % confidence interval 0.94 to 1.13 ) or in the secondary endpoints ( stroke 0.98 , 0.87 to 1.11 ; combined endpoint 1.01 , 0.93 to 1.09 ; total mortality 1.00 , 0.91 to 1.09 ) .


A community based , individually tailored intervention programme with screening for risk of ischaemic heart disease and repeated lifestyle intervention over five years had no effect on ischaemic heart disease , stroke , or mortality at the population level after 10 years.Trial registration Clinical trials NCT00289237 .


Even small design modifications of uncemented hip stems may alter the postoperative 3-D migration pattern .


The Furlong Active is an uncemented femoral stem which , in terms of design , is based on its precursor-the well-proven Furlong HAC-but has undergone several design changes .


The collar has been removed on the Active stem along with the lateral fin ; it is shorter and has more rounded edges in the proximal part .


We compared the migration patterns of the uncemented Furlong HAC stem and the modified Furlong Active stem in a randomized , controlled trial over 5 years using radiostereometry ( RSA ) .


50 patients with primary osteoarthritis were randomized to receive either the HAC stem or the Active stem .


The patients underwent repeated RSA examinations ( postoperatively , at 3 months , and after 1 , 2 , and 5 years ) and conventional radiography , and they also filled out hip-specific questionnaires .


During the first 3 months , the collarless Active stem subsided to a greater extent than the collar-fitted HAC stem ( 0.99 mm vs. 0.31 mm , p = 0.05 ) .


There were , however , no other differences in movement measured by RSA or in clinical outcome between the 2 stems .


After 3 months , both stem types had stabilized and almost no further migration was seen .


The Active stem showed no signs of unfavorable migration .


Our results suggest that the osseointegration is not compromised by the new design features .


The prone maximal restraint ( PMR ) position has been used by law enforcement and emergency care personnel to restrain acutely combative or agitated individual .


The position places the subject prone with wrists handcuffed behind the back and secured to the ankles .


Prior work has indicated a reduction in inferior vena cava ( IVC ) diameter associated with this position when weight force is applied to the back .


It is therefore possible that this position can negatively impact hemodynamic stability .


We sought to measure the impact of PMR with and without weight force on measures of cardiac function including vital signs , oxygenation , stroke volume ( SV ) , IVC diameter , cardiac output ( CO ) and cardiac index ( CI ) .


We conducted a randomized prospective cross-over experimental study of 25 healthy male volunteers ( 22-43 years of age ) placed in 5 different body positions : supine ( SU ) , prone ( PR ) , prone maximal restraint with no weight force ( PMR-0 ) , prone maximal restraint with 50lbs added to the subject 's back ( PMR-50 ) , and prone maximal restraint with 100lbs added to the subject 's back ( PMR-100 ) for 3min .


Heart rate ( HR ) , blood pressure ( BP ) , and oxygenation saturation ( O2 sat ) were monitored .


In addition , echocardiography was performed to measure left ventricular outflow tract diameter ( LVOTD ) , and SV , CO , and CI were then calculated .


Data were analyzed using repeated measures ANOVA with pair-wise comparisons when appropriate to evaluate changes with each variable with respective positioning .


Despite a small decrease in SV between SU and PMR positions , there were no statistically significant differences in CO between the 5 different positions .


There were also no differences in CI between positions other than a small decrease when comparing SU and PMR-50 only ( mean difference-0 .39 L/stroke , p = 0.005 ) .


There was no evidence of hemodynamic compromise in any of the PMR positions when evaluating HR , MAP or O2 sat .


PMR with and without weight force did not result in any changes in CO or other evidence of cardiovascular or hemodynamic compromise .


Platelet factor 4/heparin ( PF4/H ) antibody detection is widely used to evaluate the risk of thrombosis in patients undergoing hemodialysis ( HD ) .


Most patients who are PF4/H-antibody-positive can survive thrombosis , but the reason has not been clarified .


In addition , no valid preventive methods for thrombosis in patients undergoing HD have been confirmed .


A single-center , semi-randomized controlled study was designed .


In total , 157 patients fulfilled the inclusion criteria and participated .


Patients were first divided according to PF4/H antibody detection and then subdivided randomly according to different anti-platelet agent descriptions .


( 1 ) PF4/H antibody-positive patients suffered a significantly higher incidence of thrombosis than those who were antibody-negative ; ( 2 ) PF4/H antibody-positive patients who survived a thrombosis manifested a significantly longer bleeding time and decreased maximum percentage of platelet aggregation inhibition ; ( 3 ) aspirin and clopidogrel decreased the incidence of thrombosis in PF4/H antibody-positive patients by inhibiting platelet activation .


The PF4/H antibody was effective for prediction of the risk of thrombosis , except in patients with dysfunctional platelets ; aspirin manifested effects similar to clopidogrel in terms of prevention of thromboses in PF4/H antibody-positive patients , but costs much less and is therefore recommended .


Women with gestational diabetes are at high risk for developing diabetes ; post-partum weight loss may reduce the risk of diabetes .


We evaluated the association of post-partum weight change with changes in glucose , insulin and homeostasis model assessment of insulin resistance in a subsample ( n = 72 ) of participants from Diet Exercise and Breastfeeding Intervention ( DEBI ) , a randomized pilot trial of lifestyle intervention for women with gestational diabetes .


Glucose and insulin were measured fasting and 2h after an oral glucose tolerance test at 6weeks and 12months post-partum .


Women were categorized by weight change ( lost > 2kg vs. maintained/gained ) between 6weeks and 12months post-partum .


Compared with women who maintained or gained weight , women who lost > 2kg experienced significantly lower increases in fasting glucose [ age-adjusted means : 0.1 mmol/l ( 95 % CI -0.03 to 0.3 ) vs. 0.4 mmol/l ( 95 % CI 0.3-0 .6 ) ; P < 0.01 ] and 2-h insulin [ 10.0 pmol/l ( 95 % CI -56.9 to 76.9 ) vs. 181.2 pmol/l ( 95 % CI 108.3-506 .9 ) ; P < 0.01 ] and a significant reduction in 2-h glucose [ -0.9 mmol/l ( 95 % CI -1.4 to -0.3 ) vs. 0.3 mmol/l ( 95 % CI -0.3 to 0.9 ) ; P < 0.01 ] .


In multiple linear regression models adjusted for age , Hispanic ethnicity , medication use , meeting the Institute of Medicine 's recommendations for gestational weight gain , breastfeeding and randomized group , a 1-kg increase in weight was significantly associated with increases in fasting and 2-h glucose ( P < 0.05 ) , but was not associated with insulin or homeostasis model assessment of insulin resistance .


In women with gestational diabetes , modest post-partum weight loss may be associated with improvements in glucose metabolism .


Because of the increasing resistance to clarithromycin and metronidazole , new therapeutic alternatives are needed .


The purpose of this study was to compare the efficacy of 7 - and 10-day triple therapy including omeprazole , levofloxacin and amoxicilline for Helicobacter pylori eradication as a first-line therapy .


One hundred and five patients with peptic ulcer disease and with non-ulcer dyspepsia infected with Helicobacter pylori were included in this study .


Patients were randomized to receive either 7-day or 10-day therapy with omeprazole ( 20 mg b.i.d. ) , plus levofloxacin ( 500 mg o.i.d. ) and amoxicilline ( 1000 mg b.i.d. ) .


Eradication was assessed by negative histological analyses , negative H. pylori stool antigen or rapid urease test .


In Group 1 , the eradication rate was 86 , 2 % , while in group 2 , eradication rate was 93,6 % .


There was no difference between groups ( p = 0.218 ) .


Adverse effects were reported in 5 , 25 % of the patients , including nausea and diarrhea .


The levofloxacin-based regimen can be one effective therapy for the first-line anti-H .


pylori treatment .


However , a levofloxacin-based triple therapy is not generally recommended as first-line therapy at the moment due to concerns about the rising prevalence of quinolone-resistant strains in the first-line and second-line anti-H .


pylori therapies .


Aerosolized vaccine can be used as a needle-free method of immunization against measles , a disease that remains a major cause of illness and death .


Data on the immunogenicity of aerosolized vaccine against measles in children are inconsistent .


We conducted an open-label noninferiority trial involving children 9.0 to 11.9 months of age in India who were eligible to receive a first dose of measles vaccine .


Children were randomly assigned to receive a single dose of vaccine by means of either aerosol inhalation or a subcutaneous injection .


The primary end points were seropositivity for antibodies against measles and adverse events 91 days after vaccination .


The noninferiority margin was 5 percentage points .


A total of 1001 children were assigned to receive aerosolized vaccine , and 1003 children were assigned to receive subcutaneous vaccine ; 1956 of all the children ( 97.6 % ) were followed to day 91 , but outcome data were missing for 331 children because of thawed specimens .


In the per-protocol population , data on 1560 of 2004 children ( 77.8 % ) could be evaluated .


At day 91 , a total of 662 of 775 children ( 85.4 % ; 95 % confidence interval [ CI ] , 82.5 to 88.0 ) in the aerosol group , as compared with 743 of 785 children ( 94.6 % ; 95 % CI , 92.7 to 96.1 ) in the subcutaneous group , were seropositive , a difference of -9.2 percentage points ( 95 % CI , -12.2 to -6.3 ) .


Findings were similar in the full-analysis set ( 673 of 788 children in the aerosol group [ 85.4 % ] and 754 of 796 children in the subcutaneous group [ 94.7 % ] were seropositive at day 91 , a difference of -9.3 percentage points [ 95 % CI , -12.3 to -6.4 ] ) and after multiple imputation of missing results .


No serious adverse events were attributable to measles vaccination .


Adverse-event profiles were similar in the two groups .


Aerosolized vaccine against measles was immunogenic , but , at the prespecified margin , the aerosolized vaccine was inferior to the subcutaneous vaccine with respect to the rate of seropositivity .


( Funded by the Bill and Melinda Gates Foundation ; Measles Aerosol Vaccine Project Clinical Trials Registry-India number , CTRI/2009/091 / 000673 . )


To compare clinical and process outcomes of cognitive processing therapy-cognitive only version ( CPT-C ) delivered via videoteleconferencing ( VTC ) to in-person in a rural , ethnically diverse sample of veterans with posttraumatic stress disorder ( PTSD ) .


A randomized clinical trial with a noninferiority design was used to determine if providing CPT-C via VTC is effective and `` as good as '' in-person delivery .


The study took place between March 2009 and June 2013 .


PTSD was diagnosed per DSM-IV .


Participants received 12 sessions of CPT-C via VTC ( n = 61 ) or in-person ( n = 64 ) .


Assessments were administered at baseline , midtreatment , immediately posttreatment , and 3 and 6 months posttreatment .


The primary clinical outcome was posttreatment PTSD severity , as measured by the Clinician-Administered PTSD Scale .


Clinical and process outcomes found VTC to be noninferior to in-person treatment .


Significant reductions in PTSD symptoms were identified at posttreatment ( Cohen d = 0.78 , P < .05 ) and maintained at 3 - and 6-month follow-up ( d = 0.73 , P < .05 and d = 0.76 , P < .05 , respectively ) .


High levels of therapeutic alliance , treatment compliance , and satisfaction and moderate levels of treatment expectancies were reported , with no differences between groups ( for all comparisons , F < 1.9 , P > .17 ) .


Providing CPT-C to rural residents with PTSD via VTC produced outcomes that were `` as good as '' in-person treatment .


All participants demonstrated significant reductions in PTSD symptoms posttreatment and at follow-up .


Results indicate that VTC can offer increased access to specialty mental health care for residents of rural or remote areas .


ClinicalTrials.gov identifier : NCT00879255 .


New antituberculosis regimens are urgently needed to shorten tuberculosis treatment .


Following on from favourable assessment in a 2 week study , we investigated a novel regimen for efficacy and safety in drug-susceptible and multidrug-resistant ( MDR ) tuberculosis during the first 8 weeks of treatment .


We did this phase 2b study of bactericidal activity -- defined as the decrease in colony forming units ( CFUs ) of Mycobacterium tuberculosis in the sputum of patients with microscopy smear-positive pulmonary tuberculosis-at eight sites in South Africa and Tanzania .


We enrolled treatment-naive patients with drug-susceptible , pulmonary tuberculosis , who were randomly assigned by computer-generated sequences to receive either 8 weeks of moxifloxacin , 100 mg pretomanid ( formerly known as PA-824 ) , and pyrazinamide ( MPa100Z regimen ) ; moxifloxacin , 200 mg pretomanid , and pyrazinamide ( MPa200Z regimen ) ; or the current standard care for drug-susceptible pulmonary tuberculosis , isoniazid , rifampicin , PZA , and ethambutol ( HRZE regimen ) .


A group of patients with MDR tuberculosis received MPa200Z ( DRMPa200Z group ) .


The primary outcome was bactericidal activity measured by the mean daily rate of reduction in M tuberculosis CFUs per mL overnight sputum collected once a week , with joint Bayesian non-linear mixed-effects regression modelling .


We also assessed safety and tolerability by monitoring adverse events .


This study is registered with ClinicalTrials.gov , number NCT01498419 .


Between March 24 , 2012 , and July 26 , 2013 we enrolled 207 patients and randomly assigned them to treatment groups ; we assigned 60 patients to the MPa100Z regimen , 62 to the MPa200Z regimen , and 59 to the HRZE regimen .


We non-randomly assigned 26 patients with drug-resistant tuberculosis to the DRMPa200Z regimen .


In patients with drug-susceptible tuberculosis , the bactericidal activity of MPa200Z ( n = 54 ) on days 0-56 ( 0155 , 95 % Bayesian credibility interval 0133-0178 ) was significantly greater than for HRZE ( n = 54 , 0112 , 0093-0131 ) .


DRMPa200Z ( n = 9 ) had bactericidal activity of 0117 ( 0070-0174 ) .


The bactericidal activity on days 7-14 was strongly associated with bactericidal activity on days 7-56 .


Frequencies of adverse events were similar to standard treatment in all groups .


The most common adverse event was hyperuricaemia in 59 ( 29 % ) patients ( 17 [ 28 % ] patients in MPa100Z group , 17 [ 27 % ] patients in MPa200Z group , 17 [ 29 % ] patients .


in HRZE group , and 8 [ 31 % ] patients in DRMPa200Z group ) .


Other common adverse events were nausea in ( 14 [ 23 % ] patients in MPa100Z group , 8 [ 13 % ] patients in MPa200Z group , 7 [ 12 % ] patients in HRZE group , and 8 [ 31 % ] patients in DRMPa200Z group ) and vomiting ( 7 [ 12 % ] patients in MPa100Z group , 7 [ 11 % ] patients in MPa200Z group , 7 [ 12 % ] patients in HRZE group , and 4 [ 15 % ] patients in DRMPa200Z group ) .


No on-treatment electrocardiogram occurrences of corrected QT interval more than 500 ms ( an indicator of potential of ventricular tachyarrhythmia ) were reported .


No phenotypic resistance developed to any of the drugs in the regimen .


The combination of moxifloxacin , pretomanid , and pyrazinamide , was safe , well tolerated , and showed superior bactericidal activity in drug-susceptible tuberculosis during 8 weeks of treatment .


Results were consistent between drug-susceptible and MDR tuberculosis .


This new regimen is ready to enter phase 3 trials in patients with drug-susceptible tuberculosis and MDR-tuberculosis , with the goal of shortening and simplifying treatment .


Global Alliance for TB Drug Development .


Little is known about the factors that influence acceptability of and adherence to online psychological interventions .


Evidence is needed to guide further development of promising programs .


Our goal was to investigate users ' views of two online approaches to self-help for depression : computerized cognitive behavior therapy ( cCBT ) and informational websites , in a workplace context .


Computerized CBT offers an inexpensive and accessible alternative to face-to-face therapy , and employers have an interest in reducing the working time lost to depression or stress .


Yet little is known about how employees , who have actual experience of using online approaches , judge the intervention as a process .


The qualitative data reported here were collected within an online randomized controlled trial whose participants had diagnosable depression .


The experimental intervention was a 5-week cCBT program called MoodGYM , and the control condition was five informational websites about mental health .


Data were collected via online questionnaires .


There was no evidence of the superiority of either in terms of treatment outcomes .


In parallel , using brief rating scales and open-ended questions designed for this purpose , we examined the relative acceptability of each approach over time , including perceptions of cCBT compared to seeing a health care professional .


At least 60 % of participants held online therapy to be at least as acceptable as seeing a professional about mental health issues , and they were more likely to retain this opinion over time if they used the interactive program , MoodGYM , rather than informational websites alone .


Barriers to cCBT use fell into four categories : intrinsic , intrapersonal problems ; extrinsic technical problems ; generic issues mostly pertaining to perceptions of cCBT ; and specific issues about the intervention or control condition .


These indicate strategies for improving engagement .


As first-aid for mild to moderate mental health problems , evidence-based computerized approaches have broad acceptability .


This could be increased by attending to the barriers noted here and by proactively managing users ' expectations at individual and organizational levels .


The findings have implications for occupational health providers and others addressing the needs of working-age adults with depression .


They also raise methodological issues for online research .


International Standard Randomized Controlled Trial Number ( ISRCTN ) : 24529487 ; http://www.controlled-trials.com/ISRCTN24529487 ( Archived by Webcite at http://www.webcitation.org/6O8cCL4mh ) .


Opioid pharmacotherapy is now the leading treatment for chronic pain , a problem that affects nearly one third of the U.S. population .


Given the dramatic rise in prescription opioid misuse and opioid-related mortality , novel behavioral interventions are needed .


The purpose of this study was to conduct an early-stage randomized controlled trial of Mindfulness-Oriented Recovery Enhancement ( MORE ) , a multimodal intervention designed to simultaneously target mechanisms underpinning chronic pain and opioid misuse .


Chronic pain patients ( N = 115 ; mean age = 48 14 years ; 68 % female ) were randomized to 8 weeks of MORE or a support group ( SG ) .


Outcomes were measured at pre - and posttreatment , and at 3-month follow-up .


The Brief Pain Inventory was used to assess changes in pain severity and interference .


Changes in opioid use disorder status were measured by the Current Opioid Misuse Measure .


Desire for opioids , stress , nonreactivity , reinterpretation of pain sensations , and reappraisal were also evaluated .


MORE participants reported significantly greater reductions in pain severity ( p = .038 ) and interference ( p = .003 ) than SG participants , which were maintained by 3-month follow-up and mediated by increased nonreactivity and reinterpretation of pain sensations .


Compared with SG participants , participants in MORE evidenced significantly less stress arousal ( p = .034 ) and desire for opioids ( p = .027 ) , and were significantly more likely to no longer meet criteria for opioid use disorder immediately following treatment ( p = .05 ) ; however , these effects were not sustained at follow-up .


Findings demonstrate preliminary feasibility and efficacy of MORE as a treatment for co-occurring prescription opioid misuse and chronic pain .


( PsycINFO Database Record ( c ) 2014 APA , all rights reserved ) .


Glycemic control improves with physical activity , but the optimal exercise mode is unknown .


The objective of the study was to determine whether interval-based exercise improves postprandial glucose tolerance and free-living glycemia more than oxygen consumption - and time duration-matched continuous exercise .


This was a crossover , controlled study with trials performed in randomized order .


The study was conducted in hospitalized and ambulatory care .


PATIENTS diagnosed with type 2 diabetes mellitus ( n = 10 , no withdrawals ) participated in the study .


Subjects performed three 1-hour interventions : 1 ) interval walking ( IW ; repeated cycles of 3 min of slow and fast walking ) ; 2 ) continuous walking ( CW ) ; and 3 ) control ( CON ) .


Oxygen consumption ( VO2 ) was measured continuously to match mean VO2 between exercise sessions ( 75 % VO2peak ) .


A mixed-meal tolerance test ( MMTT ; 450 kcal , 55 % carbohydrate ) with stable glucose isotopic tracers was provided after each intervention , and glucose kinetics were measured during the following 4 hours .


Free-living glycemic control was assessed for approximately 32 hours after the MMTT using continuous glucose monitoring .


VO2 was well matched between the exercise interventions .


IW decreased the mean and maximal incremental plasma glucose during the MMTT when compared with the CON ( mean 1.2 0.4 vs 2.0 0.5 mmol/L , P < .001 ; maximal 3.7 0.6 vs 4.6 0.7 mmol/L , P = .005 ) and mean when compared with CW ( 1.7 0.4 mmol/L , P = .02 ) .


No differences in the mean or maximal incremental plasma glucose values were seen between the CW and CON .


The metabolic clearance rate of glucose during the MMTT was increased in the IW compared with CW ( P = .049 ) and CON ( P < .001 ) .


Continuous glucose monitoring mean glucose was reduced in IW compared with CW for the rest of the intervention day ( 8.2 0.4 vs 9.3 0.7 mmol/L , P = .03 ) , whereas no differences were found between IW and CW the following day .


One interval-based exercise session improves glycemic control in type 2 diabetes mellitus subjects when compared with an oxygen consumption - and time duration-matched continuous exercise session .


To determine if a computer-based simulation with haptic technology can help surgical trainees improve tactile discrimination using surgical instruments .


Twenty junior medical students participated in the study and were randomized into two groups .


Subjects in Group A participated in virtual simulation training using the ImmersiveTouch simulator ( ImmersiveTouch , Inc. , Chicago , IL , USA ) that required differentiating the firmness of virtual spheres using tactile and kinesthetic sensation via haptic technology .


Subjects in Group B did not undergo any training .


With their visual fields obscured , subjects in both groups were then evaluated on their ability to use the suction and bipolar instruments to find six elastothane objects with areas ranging from 1.5 to 3.5 cm2 embedded in a urethane foam brain cavity model while relying on tactile and kinesthetic sensation only .


A total of 73.3 % of the subjects in Group A ( simulation training ) were able to find the brain cavity objects in comparison to 53.3 % of the subjects in Group B ( no training ) ( P = 0.0183 ) .


There was a statistically significant difference in the total number of Group A subjects able to find smaller brain cavity objects ( size 2.5 cm2 ) compared to that in Group B ( 72.5 vs. 40 % , P = 0.0032 ) .


On the other hand , no significant difference in the number of subjects able to detect larger objects ( size 3 cm2 ) was found between Groups A and B ( 75 vs. 80 % , P = 0.7747 ) .


Virtual computer-based simulators with integrated haptic technology may improve tactile discrimination required for microsurgical technique .


Inhaled corticosteroids ( ICS ) reduce exacerbation rates and improve health status but can increase the risk of pneumonia in COPD .


The GLUCOLD study , investigating patients with mild-to-moderate COPD , has shown that long-term ( 2.5-year ) ICS therapy induces anti-inflammatory effects .


The literature suggests that cigarette smoking causes ICS insensitivity .


The aim of this study is to compare anti-inflammatory effects of ICS in persistent smokers and persistent ex-smokers in a post-hoc analysis of the GLUCOLD study .


Persistent smokers ( n = 41 ) and persistent ex-smokers ( n = 31 ) from the GLUCOLD cohort were investigated .


Effects of ICS treatment compared with placebo were estimated by analysing changes in lung function , hyperresponsiveness , and inflammatory cells in sputum and bronchial biopsies during short-term ( 0-6 months ) and long-term ( 6-30 months ) treatment using multiple regression analyses .


Bronchial mast cells were reduced by short-term and long-term ICS treatment in both smokers and ex-smokers .


In contrast , CD3 , CD4 , and CD8 cells were reduced by short-term ICS treatment in smokers only .


In addition , sputum neutrophils and lymphocytes , and bronchial CD8 cells were reduced after long-term treatment in ex-smokers only .


No significant interactions existed between smoking and ICS treatment .


Even in the presence of smoking , long-term ICS treatment may lead to anti-inflammatory effects in the lung .


Some anti-inflammatory ICS effects are comparable in smokers and ex-smokers with COPD , other effects are cell-specific .


The clinical relevance of these findings , however , are uncertain .


Inadequate skin care may increase morbidity in preterm infants .


Skin care practices that support skin maturation have barely been investigated .


To investigate the effect of sunflower seed oil ( SSO ) on skin barrier development in low-birth-weight premature infants .


22 preterm infants ( < 48 h after birth , 1,500-2 ,500 g ) were randomized into group C ( control ) and group SSO , receiving daily SSO application during the first 10 postnatal days , followed by no intervention .


Transepidermal water loss ( TEWL ) , stratum corneum hydration ( SCH ) , skin pH and sebum were measured < 48 h after birth and on postnatal days 5 , 11 and 21 on the forehead , abdomen , thigh and buttock .


Skin pH decreased , while sebum remained stable in both groups .


In group C , TEWL remained stable ; in group SSO , TEWL increased significantly on the abdomen , leg and buttock until day 11 , followed by a decrease after SSO application had been stopped .


Abdomen SCH remained stable in group C , but continuously decreased in group SSO until day 21 .


SSO application may retard postnatal skin barrier maturation in preterm infants .


It is common in public health and epidemiology that the outcome of interest is counts of events occurrence .


Analysing these data using classical linear models is mostly inappropriate , even after transformation of outcome variables due to overdispersion .


Zero-adjusted mixture count models such as zero-inflated and hurdle count models are applied to count data when over-dispersion and excess zeros exist .


Main objective of the current paper is to apply such models to analyse risk factors associated with human helminths ( S. haematobium ) particularly in a case where there 's a high proportion of zero counts .


The data were collected during a community-based randomised control trial assessing the impact of mass drug administration ( MDA ) with praziquantel in Malawi , and a school-based cross sectional epidemiology survey in Zambia .


Count data models including traditional ( Poisson and negative binomial ) models , zero modified models ( zero inflated Poisson and zero inflated negative binomial ) and hurdle models ( Poisson logit hurdle and negative binomial logit hurdle ) were fitted and compared .


Using Akaike information criteria ( AIC ) , the negative binomial logit hurdle ( NBLH ) and zero inflated negative binomial ( ZINB ) showed best performance in both datasets .


With regards to zero count capturing , these models performed better than other models .


This paper showed that zero modified NBLH and ZINB models are more appropriate methods for the analysis of data with excess zeros .


The choice between the hurdle and zero-inflated models should be based on the aim and endpoints of the study .


To investigate the effect of cryotherapy after elbow arthrolysis on elbow pain , blood loss , analgesic consumption , range of motion , and long-term elbow function .


Prospective , single-blinded , randomized controlled study .


University hospital .


Patients ( N = 59 ; 27 women , 32 men ) who received elbow arthrolysis .


Patients were randomly assigned into a cryotherapy group ( n = 31 , cryotherapy plus standard care ) or a control group ( n = 28 , standard care ) .


Elbow pain at rest and in motion were measured using a visual analog scale ( VAS ) on postoperative day ( POD ) 1 to POD 7 and at 2 weeks and 3 months after surgery .


Blood loss and analgesic consumption were recorded postoperatively .


Elbow range of motion ( ROM ) was measured before surgery and on POD 1 , POD 7 , and 3 months after surgery .


The Mayo Elbow Performance Score ( MEPS ) was evaluated preoperatively and 3 months postoperatively .


VAS scores were significantly lower in the cryotherapy group during the first 7 PODs , both at rest and in motion ( P < .05 ) .


There were no significant differences between the 2 groups in VAS scores at 2 weeks and 3 months after surgery .


Less sufentanil was consumed by the cryotherapy group than the control group for pain relief ( P < .01 ) .


No significant differences were found in blood loss , ROM , and MEPS between the 2 groups ( P > .05 ) .


Cryotherapy is effective in relieving pain and reducing analgesic consumption for patients received elbow arthrolysis .


The application of cryotherapy will not affect blood loss , ROM , or elbow function .


To assess the effectiveness of brief motivational intervention for alcohol and drug use in young adult primary care patients in a low-income population and country .


A randomized controlled trial in a public-sector clinic in Delft , a township in the Western Cape , South Africa recruited 403 patients who were randomized to either single-session , nurse practitioner-delivered Brief Motivational Intervention plus referral list or usual care plus referral list , and followed up at 3 months .


Although rates of at-risk alcohol use and drug use did not differ by treatment arm at follow-up , patients assigned to the Brief Motivational Intervention had significantly reduced scores on ASSIST ( Alcohol , Smoking and Substance Involvement Screening Test ) for alcohol-the most prevalent substance .


Brief Motivational Intervention may be effective at reducing at-risk alcohol use in the short term among low-income young adult primary care patients ; additional research is needed to examine long-term outcomes .


Prior studies have provided evidence that lifestyle change prevents or delays the occurrence of type 2 diabetes mellitus .


The challenge is to translate research evidence for type 2 diabetes mellitus prevention into health care settings .


We investigated the effect of medical nutrition therapy ( MNT ) compared with usual care on fasting plasma glucose values , glycated hemoglobin ( HbA1c ) , serum lipid levels , and Diabetes Risk Score , from baseline to the end of a 12-week intervention in overweight or obese adults with prediabetes .


Prospective , randomized , parallel group study of 76 adults with impaired fasting plasma glucose or an HbA1c of 5.7 % to 6.4 % , recruited between April 2010 and May 2011 who completed a 12-week intervention period .


The primary outcome measure was fasting plasma glucose .


Secondary outcome measures were HbA1c , serum lipid levels , and Diabetes Risk Score .


A factorial repeated measures analysis of variance was used to make comparisons between the two groups ( the MNT and usual care groups ) and two measures of time ( baseline and 12 weeks postintervention ) .


Data analysis was performed using the Statistical Package for the Social Sciences ( release 19.0 , 2010 , SPSS Inc ) .


There was a significant interaction for group assignment and HbA1c ( P = 0.01 ) , with the MNT group experiencing significantly lower HbA1c levels than the usual care group ( 5.79 % vs 6.01 % ) after the 12-week intervention .


There was a significant interaction for group assignment and Diabetes Risk Score ( P = 0.001 ) .


Diabetes Risk Score for the MNT group decreased from 17.543.69 to 15.313.79 compared with the usual care group score , which went from 17.234.69 to 16.834.73 .


Regardless of group assignment , both groups experienced a reduction in total cholesterol ( P = 0.01 ) and low-density lipoprotein cholesterol ( P = 0.04 ) level .


The results demonstrate that individualized MNT is effective in decreasing HbA1c level in patients diagnosed with prediabetes .


To evaluate the effect of an intensive early intervention on special service use at school-age .


The Infant Health and Development Program was a randomized controlled trial of an intervention for low birth weight ( < 2500 g ) infants ages 0-3 years .


We used multivariate logistic regression to test the association between intervention and risk of special education , remedial reading and math , and speech therapy at age 8 years .


We also compared rates of service use between study arms among those with learning disabilities ( LDs ) .


There were 875 complete cases at 8-year follow-up .


There were no statistically significant differences between groups in risk of special education ( risk ratio [ RR ] 0.86 , 95 % CI 0.64-1 .15 ) , remedial reading ( RR 0.88 , 95 % CI 0.68-1 .14 ) , remedial math ( RR 0.92 , 95 % CI 0.63-1 .34 ) , or speech therapy ( RR 0.87 , 95 % CI 0.62-1 .23 ) .


The treatment arms did not differ in rates of LDs , and service use for those with LDs was low and unaffected by study group .


Early gains in IQ from infant interventions may not protect children as they face the educational demands of grade school .


Only a fraction of those having a LD were receiving school-based support services , indicating a high level of unmet need among low birth weight children with disabilities .


To compare baseline characteristics , treatment frequency , visual acuity ( VA ) , and morphologic outcomes of eyes with > 50 % of the lesion composed of blood ( B50 group ) versus all other eyes ( Other group ) enrolled in the Comparison of Age-Related Macular Degeneration Treatments Trials ( CATT ) .


Prospective cohort study within a multicenter randomized clinical trial .


CATT patients with neovascular age-related macular degeneration ( AMD ) .


Treatment for the study eye was assigned randomly to either ranibizumab or bevacizumab and to 3 different dosing regimens over a 2-year period .


Reading center graders evaluated baseline and follow-up morphology in color fundus photographs , fluorescein angiography ( FA ) , and optical coherence tomography ( OCT ) .


Masked examiners tested VA. .


Morphologic features and VA at 1 and 2 years .


The B50 group consisted of 84 of 1185 ( 7.1 % ) patients enrolled in CATT .


Baseline lesion characteristics differed between groups .


In the B50 group , choroidal neovascularization size was smaller ( 0.73 vs 1.83 disc areas [ DA ] ; P < 0.001 ) , total lesion size was greater ( 4.55 vs 2.31 DA ; P < 0.001 ) , total retinal thickness was greater ( 524 vs 455 m ; P = 0.02 ) , and mean VA was worse ( 56.0 vs 60.9 letters ; P = 0.002 ) .


Increases in mean VA were similar in the B50 and Other groups at 1 year ( +9.3 vs +7.2 letters ; P = 0.22 ) and at 2 years ( 9.0 vs 6.1 letters ; P = 0.17 ) .


Eyes treated PRN received a similar number of injections in the 2 groups ( 12.2 vs 13.4 ; P = 0.27 ) .


Mean lesion size in the B50 group decreased by 1.2 DA at both 1 and 2 years ( primarily owing toresolution of hemorrhage ) and increased in the Other group by 0.33 DA at 1 year and 0.91 DA at 2 years ( P < 0.001 ) .


Leakage on FA and fluid on OCT were similar between groups at 1 and 2 years .


In CATT , the B50 group had a visual prognosis similar to the Other group .


Lesion size decreased markedly through 2 years .


Eyes like those enrolled in CATT with neovascular AMD lesions composed of > 50 % blood can be managed similarly to those with less or no blood .


Women with gestational diabetes ( GDM ) are at high risk of developing diabetes later in life .


After a GDM diagnosis , women receive prenatal care to control their blood glucose levels via diet , physical activity and medications .


Continuing such lifestyle skills into early motherhood may reduce the risk of diabetes in this high risk population .


In the Gestational Diabetes ' Effects on Moms ( GEM ) study , we are evaluating the comparative effectiveness of diabetes prevention strategies for weight management designed for pregnant/postpartum women with GDM and delivered at the health system level .


The GEM study is a pragmatic cluster randomized clinical trial of 44 medical facilities at Kaiser Permanente Northern California randomly assigned to either the intervention or usual care conditions , that includes 2,320 women with a GDM diagnosis between March 27 , 2011 and March 30 , 2012 .


A Diabetes Prevention Program-derived print/telephone lifestyle intervention of 13 telephonic sessions tailored to pregnant/postpartum women was developed .


The effectiveness of this intervention added to usual care is to be compared to usual care practices alone , which includes two pages of printed lifestyle recommendations sent to postpartum women via mail .


Primary outcomes include the proportion of women who reach a postpartum weight goal and total weight change .


Secondary outcomes include postpartum glycemia , blood pressure , depression , percent of calories from fat , total caloric intake and physical activity levels .


Data were collected through electronic medical records and surveys at baseline ( soon after GDM diagnosis ) , 6 weeks ( range 2 to 11 weeks ) , 6 months ( range 12 to 34 weeks ) and 12 months postpartum ( range 35 to 64 weeks ) .


There is a need for evidence regarding the effectiveness of lifestyle modification for the prevention of diabetes in women with GDM , as well as confirmation that a diabetes prevention program delivered at the health system level is able to successfully reach this population .


Given the use of a telephonic case management model , our Diabetes Prevention Program-derived print/telephone intervention has the potential to be adopted in other settings and to inform policies to promote the prevention of diabetes among women with GDM .


Inadvertent arterial placement of a femoral venous catheter may result in serious morbidity , including limb necrosis .


The Flush the Line and Ultrasound the Heart ( FLUSH ) test is visualization of the heart by a subxiphoid ultrasonic view while the central catheter is flushed with agitated saline solution .


We wish to determine whether the FLUSH test can verify proper femoral venous line placement .


We prospectively studied a convenience sample of children undergoing cardiac catheterization , for whom both femoral venous and arterial access were part of their standard care .


The cardiologist flushed manually agitated saline solution through each catheter in randomized sequence while the blinded physician sonographer recorded thepresence or absence of right atrial opacification .


We calculated the sensitivity and specificity of the FLUSH test relative to our reference standard , the cardiologist 's fluoroscopic visualization of catheter wire placement .


Of the 51 subjects enrolled , the FLUSH test was 100 % sensitive ( 95 % confidence interval 95 % to 100 % ) and 90.3 % specific ( 95 % confidence interval 81 % to 96 % ) in confirming femoral catheter placement .


In no case was an arterial flush misidentified as a femoral flush .


The interrater reliability of the test was strong : 0.82 for all images and 0.9 for those of good quality .


The FLUSH test is simple and reliable , and appears to accurately confirm femoral venous line placement .


Polyethylene glycol 3350 plus sports drink ( PEG-SD ) is a hypo-osmotic purgative commonly used for colonoscopy , though little safety data are available .


To evaluate the effect of PEG-SD on serum sodium ( Na ) and other electrolytes compared with PEG-electrolyte solution ( PEG-ELS ) .


We performed a single center , prospective , randomised , investigator-blind comparison of PEG-ELS to PEG-SD in out-patients undergoing colonoscopy .


Laboratories were obtained at baseline and immediately before and after colonoscopy .


The primary endpoint was development of hyponatraemia ( Na < 135 mmol/L ) the day of colonoscopy .


Changes in electrolyte levels were computed as the difference between the lowest value on the day of colonoscopy and baseline .


Purgative tolerance and efficacy were assessed .


A total of 389 patients were randomised ; 364 took purgative and had baseline and day of colonoscopy labs ( 180 PEG-SD , 184 PEG-ELS ) .


The groups were well matched except for a higher fraction of women and Blacks in PEG-ELS .


Seven patients ( 3.9 % ) in PEG-SD and four patients ( 2.2 % ) in PEG-ELS developed hyponatraemia ( OR = 1.82 , 95 % CI : 0.45-8 .62 , P = 0.376 ) .


Changes in electrolytes from baseline were small but significantly worse with PEG-SD for sodium , potassium and chloride ( P = 0.001 , 0.012 , 0.001 , respectively ) .


Preparation completion , adverse events , and overall colon cleansing were similar between the groups , but PEG-ELS had more excellent preparations ( 52 % vs. 30 % ; P = 0.001 ) .


Greater , but very modest , electrolyte changes occur with PEG-SD .


Hyponatraemia is infrequent with both purgatives .


A significant increase in hyponatraemia was not identified for PEG-SD vs. PEG-ELS , but the sample size may have been inadequate to identify a small , but clinically important difference .


ClinicalTrials.gov identifier NCT01299779 .


Beclomethasone dipropionate ( BDP ) nasal aerosol ( non-aqueous ) is approved for management of seasonal and perennial allergic rhinitis ( PAR ) in adolescents and adults .


To evaluate the efficacy and safety of BDP nasal aerosol at 80 g/day in children with PAR .


This 12-week , phase 3 , double-blinded , placebo-controlled , parallel-group study randomized 547 children ( 4-11 years old ) with PAR to once-daily BDP nasal aerosol at 80 g/day or placebo .


The primary end point was change from baseline in average morning and evening reflective total nasal symptom score ( rTNSS ) during the first 6 weeks of treatment in patients 6 to 11 years old .


Changes from baseline in average morning and evening instantaneous TNSS ( iTNSS ) in children 6 to 11 years old and average rTNSS and iTNSS in children 4 to 11 years old were assessed during the first 6 weeks of treatment .


Improvements were significantly greater with BDP nasal aerosol than with placebo during the first 6 weeks of treatment in children 6 to 11 years old in average morning and evening rTNSS and iTNSS ( mean treatment difference-0 .66 [ P = .002 ] and-0 .58 [ P = .004 ] , respectively ) .


Improvements in average morning and evening rTNSS and iTNSS also were significantly greater in patients 4 to 11 years receiving BDP nasal aerosol than with placebo during the first 6 weeks of treatment ( P = .002 and P = .004 , respectively ) .


Similar improvements were seen during 12 weeks of treatment .


The safety profile of BDP nasal aerosol was comparable to that of placebo .


The BDP nasal aerosol at 80 g/day in children 4 to 11 years old was well tolerated and effective in controlling nasal symptoms of PAR .


www.clinicaltrials.gov , identifier NCT01783548 .


Wound drains that are left in place for a prolonged period of time have a higher rate of bacterial contamination .


Following spinal surgery , a drain is often left in place for a longer period of time if it maintains a high output .


Given the major consequences of an infection following spinal surgery and the lack of data with regard to the use of antibiotics and drains , we performed a study of patients with a drain following spinal surgery to compare infection rates between those who were treated with antibiotics for twenty-four hours and those who received antibiotics for the duration for which the drain was in place .


We performed a prospective randomized trial of 314 patients who underwent multilevel thoracolumbar spinal surgery followed by use of a postoperative drain .


The patients were randomized into two groups , one of which received perioperative antibiotics for twenty-four hours ( twenty-four-hour group ) and the other of which received antibiotics for the duration that the drain was in place ( drain-duration group ) .


Data collected included demographic characteristics , medical comorbidities , type of spinal surgery , and surgical site infection .


Twenty-one ( 12.4 % ) of the 170 patients in the twenty-four-hour group and nineteen ( 13.2 % ) of the 144 in the drain-duration group developed a surgical site infection ( p = 0.48 ) .


There were no significant differences between the twenty-four-hour and drain-duration groups with respect to demographic characteristics ( except for the American Society of Anesthesiologists [ ASA ] classification ) , operative time , type of surgery , drain output , or length of hospital stay .


Continuing perioperative administration of antibiotics for the entire duration that a drain is in place after spinal surgery did not decrease the rate of surgical site infections .


To compare the frequency of headache and the procedure time following lumbar puncture ( LP ) using a 25-gauge needle compared to a 22-gauge needle .


4-period crossover blinded randomised controlled trial .


Oncology unit , Royal Children 's Hospital , Melbourne .


Children aged 4-15 years at enrolment having LPs as part of their treatment for leukaemia .


Each child was allocated a random sequence of four LPs , two with a 22-gauge and two with a 25-gauge needle .


The presence of post-LP headache .


Secondary outcomes included the presence of any headache , procedure time and impact of headache on the family .


Data on 341 procedures in 93 randomised children were analysed .


There was little difference in the incidence of post-LP headache between the two needle sizes ( 22-gauge 7.2 % , 95 % CI 3.8 to 12.2 ; 25-gauge 4.6 % , 95 % CI 2.0 to 8.9 , p = 0.3 ) or in the incidence of any headache ( 22-gauge 18 % 95 % CI 12.5 to 24.6 ; 25-gauge 15 % , 95 % CI 10.0 to 21.1 , p = 0.4 ) .


Use of the 25-gauge needle was associated with longer procedure times .


The incidence of post-LP headache showed little evidence of an age effect ( OR = 1.1 , 95 % CI 0.98 to 1.3 ) and was higher in girls than in boys ( 11 % vs 3 % , respectively , OR = 3.3 , 95 % CI 1.3 to 8.4 , p = 0.014 ) .


Fifty-five per cent of families with a child with a post-LP headache assessed the overall functional impact as moderate or severe .


There was little difference in the occurrence of post-LP headache or any headache between procedures carried out using the 22-gauge or 25-gauge needles .


Depending on the circumstances of the procedure and the experience of the operator , either gauge may be appropriate for an LP in a child .


An interferon-free combination of the protease inhibitor ABT-450 with ritonavir ( ABT-450 / r ) , the nonnucleoside polymerase inhibitor ABT-333 , and ribavirin showed efficacy against the hepatitis C virus ( HCV ) in a pilot study involving patients with HCV genotype 1 infection .


The addition of another potent agent , the NS5A inhibitor ABT-267 , may improve efficacy , especially in difficult-to-treat patients .


This study was designed to evaluate multiple regimens of direct-acting antiviral agents and ribavirin in patients with HCV genotype 1 infection who had not received therapy previously or who had no response to prior therapy with pegylated interferon and ribavirin .


In this phase 2b , open-label study with 14 treatment subgroups , 571 patients without cirrhosis who had not received treatment previously or who had not had a response to prior therapy were randomly assigned to a regimen of ABT-450 / r , combined with ABT-267 or ABT-333 or both , for 8 , 12 , or 24 weeks and received at least one dose of therapy .


All the subgroups but 1 also received ribavirin ( dose determined according to body weight ) .


The primary end point was sustained virologic response at 24 weeks after the end of treatment .


The primary efficacy analysis compared rates between previously untreated patients who received three direct-acting antiviral agents and ribavirin for 8 weeks and those who received the same therapy for 12 weeks .


Among previously untreated patients who received three direct-acting antiviral agents ( with the ABT-450 / r dose administered as 150 mg of ABT-450 and 100 mg of ritonavir ) plus ribavirin , the rate of sustained virologic response at 24 weeks after treatment was 88 % among those who received the therapy for 8 weeks and 95 % among those who received the therapy for 12 weeks ( difference , -7 percentage points ; 95 % confidence interval , -19 to 5 ; P = 0.24 ) .


The rates of sustained virologic response across all treatment subgroups ranged from 83 to 100 % .


The most frequent adverse events were fatigue , headache , nausea , and insomnia .


Eight patients ( 1 % ) discontinued treatment owing to adverse events .


In this phase 2b study , all-oral regimens of antiviral agents and ribavirin were effective both in patients with HCV genotype 1 infection who had not received therapy previously and in those who had not had a response to prior therapy .


( Funded by AbbVie ; ClinicalTrials.gov number , NCT01464827 . )


The challenge with fast track ( FT ) is to avoid compromising medical safety .


We aimed to investigate whether patients with acute coronary syndrome could be safely retransferred to the referral hospital on the same day after coronary angiography and/or percutaneous coronary angioplasty ( PCI ) .


A total of 399 consecutive patients were prospectively randomized : 206 to ordinary care ( OC ) and 193 to the FT group .


Of these , 30 % of patients were admitted for unstable angina pectoris and 70 % for non-ST-segment elevation myocardial infarction .


The FT patients were evaluated for possible same-day return after angiography and/or PCI .


Crossover , acute , and 30-day major events were recorded .


The radial approach was used in 91 and 87 % in the OC and FT group , respectively .


Of the FT patients , 95 % were returned on the same day and nine crossover patients ( 4.7 % ) the next day or later .


Major events occurred in nine patients ( 2.2 % ) ; five in the OC and four in the FT group .


There were a total of five events within 24 hours .


No events were observed during transportation and there were no early retransfers .


Immediate written reports and good communication with the referring hospital enabled thoroughly selected patients to be safely returned on the same day as angiography and/or PCI .


This study aimed to compare the clinical efficacies of percutaneous endoscopic lumbar discectomy ( PELD ) and traditional open lumbar discectomy ( OD ) .


The pre-operative and post-operative blood loss , hospital stays and wound sizes of the patients in the two groups were recorded .


Enzyme-Linked immunosorbent assay was used to measure the changes of interleukin-6 ( IL-6 ) , C-reactive protein ( CRP ) and creatine phosphokinase ( CPK ) pre-operation and 1 h , 6 h , 12 h , 24 h and 48 h after corresponding surgery .


Visual Analog Scale and Modified MacNab Criteria were used to assess post-operative results .


Patients in the PELD group had less blood loss ( p < 0.01 ) , shorter hospitalization hours ( p < 0.01 ) and smaller surgical wounds ( p < 0.01 ) than the patients underwent traditional OD surgery .


MacNab evaluated that the levels of satisfaction were above 90 % in both groups post-operative six months .


There was no significant difference in pain index between the two groups ( p > 0.05 ) .


Furthermore , the levels of CRP , CPK and IL-6 in the PELD group were all lower than those in the OD group with a significant difference ( p < 0.01 ) .


The PELD had less damage to human tissues than the traditional OD .


PELD has a clear promotional value in clinical .


Chronic pain is a common complication after inguinal hernia repair .


The objective of this randomized trial was to assess the effect of intraoperative infiltration with local anesthetic versus placebo on the development of chronic pain after inguinal hernia repair .


Patients with single - or double-sided inguinal hernia were enrolled in a randomized , controlled , triple-blinded trial with a sequential adaptive design .


Hernias were randomized to 1 of 2 treatment groups .


The intervention group received a local infiltration of 20 mL bupivacaine 0.25 % and the placebo group 20 mL saline 0.9 % at the end of the operation .


Two interim analyses were performed according to predefined stopping criteria allowing for design and sample size adaption .


The primary endpoint was chronic pain defined on a visual analog scale ( VAS ) as 30 in any quality ( at rest , lying , walking , climbing stairs , and bending over ) 3 months postoperatively .


A logistic regression model was built to compare the incidence of chronic pain using generalized estimating equations to adjust for clustering in bilateral hernias .


Among 357 patients , there were 406 hernias randomized .


A total of 5.8 % ( 10/173 ) experienced VAS 30 in any quality in the intervention group and 2.3 % ( 4/174 ) in the placebo group ( P = .114 ) at 3 months postoperatively .


Multivariable analysis revealed no evidence of between-group differences for the development of any pain ( odds ratio [ OR ] , 1.03 ; 95 % CI , 0.67-1 .57 ; P = .905 ) , whereas preoperative pain was an independent risk factor ( OR , 2.52 ; 95 % CI , 1.12-5 .68 ; P = .025 ) .


We did not find any evidence that intraoperative infiltration of local anesthetic had an impact on the development of chronic postoperative pain .


To evaluate the clinical usefulness of the Peyronie 's Disease Questionnaire ( PDQ ) .


The relationship between subject-reported changes in PDQ psychosexual symptoms and clinical response to Peyronie 's disease ( PD ) treatment was examined .


Combined data from the collagenase Clostridium histolyticum phase 3 study program , IMPRESS ( Investigation for Maximal Peyronie 's Reduction Efficacy and Safety Studies ) I and II , were examined .


Changes in the PDQ PD symptom bother , psychological and physical symptoms , and penile pain were examined relative to changes in the penile curvature deformity , including penile curvature absolute mean and percent change .


PDQ changes relative to sexual function , including International Index of Erectile Function overall satisfaction and erectile function domains , and treatment responder status , including global assessment of PD and composite responder status , were also assessed .


Individual PDQ questions were examined to provide a clinical perspective on the change in psychosexual symptoms experienced by men with PD during treatment .


Improvement in PDQ PD symptom bother and psychological and physical symptoms was significantly correlated with clinical improvement in penile curvature deformity ( P. 0008 ) and sexual function ( P < .0001 ) .


Significant differences in PD symptom bother and psychological and physical symptoms improvement were found between treatment responders vs nonresponders ( P < .02 ) .


PDQ penile pain improvement among subjects reporting baseline pain4 was significantly correlated with clinical improvement in sexual function ( P. 0004 ) and was found to be greater in treatment responders vs nonresponders ( P = .003 ) .


The utility of the PDQ for monitoring PD-specific psychosexual symptom severity , progression , and treatment response , both clinically and in trials of men with PD , was supported .


In patients suffering from bipolar disorders ( BPD ) , we explored to what extent oral loading of sodium valproate ( SV ) leads to more rapid symptom improvement compared to intravenous loading and oral maintenance administration .


Ninety patients ( mean age : 35.00 years ) with BPD and currently in an acute manic state were randomly assigned to one of three study conditions : oral loading ( 20 mg/kg oral single-dose SV on the first day , then 10-15 mg/kg SV daily , divided dose ) , intravenous loading ( 20 mg/kg SV intravenous injection on the first day , then 10-15 mg/kg orally , divided dose ) , or oral maintenance administration ( 15-20 mg/kg SV daily from the beginning ) over the first 7 days of treatment .


SV plasma levels , side effects and symptoms were evaluated at baseline and on days 1 , 3 , and 7 after commencing treatment .


There were significant Time-by-Group interactions for symptom improvements , symptom severity , and SV plasma levels , with positive values in the oral and intravenous loading conditions , compared to the oral maintenance condition .


Post hoc analyses showed that oral and intravenous conditions led to similar improvements .


Both oral and intravenous loading of SV led to quicker and more efficient improvement and SV plasma levels as compared to an oral maintenance regimen .


Schizoaffective disorder is a complex illness for which optimal treatment is not well established .


Results of the first controlled , relapse-prevention study of paliperidone palmitate once-monthly injectable ( paliperidone monthly ) in schizoaffective disorder are presented .


The study was conducted between September 20 , 2010 , and October 22 , 2013 .


Patients with schizoaffective disorder ( confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders ) experiencing acute exacerbation of psychotic and depressive/manic symptoms were stabilized with paliperidone monthly as monotherapy or as adjunctive therapy to mood stabilizers or antidepressants and randomly assigned ( 1:1 ) to paliperidone monthly or placebo in a 15-month , double-blind , relapse-prevention phase .


Randomization was stratified by administration as monotherapy or adjunctive therapy and by study center .


The primary endpoint was time to relapse .


334 patients were evaluated .


Paliperidone monthly significantly delayed time to relapse for psychotic , depressive , and manic symptoms compared with placebo ( P < .001 , log-rank test ) .


Relapse risk was 2.49 times greater for placebo ( hazard ratio = 2.49 ; 95 % CI , 1.55 to 3.99 ; P < .001 , Cox proportional hazards model ) .


Overall relapse rates were 33.5 % for placebo and 15.2 % for paliperidone monthly .


For monotherapy , relapse risk was 3.38 times greater with placebo ( P = .002 ) , and for adjunctive treatment it was 2.03 times greater with placebo ( P = .021 ) .


Paliperidone monthly was superior to placebo in maintaining functioning as measured by the Personal and Social Performance scale ( P = .014 , mixed-model repeated-measures analysis ) .


The most common adverse events ( placebo , paliperidone monthly ) were increased weight ( 4.7 % , 8.5 % ) , insomnia ( 7.1 % , 4.9 % ) , schizoaffective disorder ( 5.9 % , 3.0 % ) , headache ( 3.5 % , 5.5 % ) , and nasopharyngitis ( 3.5 % , 5.5 % ) .


Incidence of any extrapyramidal-related adverse event was 7.1 % for placebo and 8.5 % for paliperidone monthly .


Paliperidone monthly as monotherapy or adjunctive therapy significantly delayed psychotic , depressive , and/or manic relapses ; reduced their risk ; and better maintained functioning in patients with schizoaffective disorder .


Results support the value of maintenance treatment with paliperidone monthly in schizoaffective disorder .


ClinicalTrials.gov identifier : NCT01193153 .


The purpose of this study was to examine the long-term effects of the Early Risers `` Skills for Success '' Conduct Problems Prevention Program ( ER ; August , Bloomquist , Realmuto , & Hektner , 2007 ) , a multifaceted program targeting social , emotional , behavioral , and academic risk and protective factors to promote adaptive psychological development .


Based on the random assignment of their school , 245 kindergartners ( mean age = 6.6 years , SD = 0.57 ; 68.6 % male ) with elevated teacher-rated aggressive behavior either participated in ER for 3 intensive years plus 2 booster years or served as controls .


Participants were assessed annually during the intervention with teacher and parent reports and at 2 follow-up points .


In the current study , 129 of the original participants were reassessed with diagnostic interviews in late high school ( mean age = 16.3 , SD = 0.52 ) , and multiple imputation was used to deal appropriately with missing data .


Program participants had significantly fewer symptoms of conduct disorder , oppositional defiant disorder , and major depressive disorder than did controls .


The program 's effect on increasing social skills and parent discipline effectiveness by Grade 3 mediated these effects .


The results of this study provide further evidence of the long-term positive effects of multicomponent , elementary-age , targeted conduct problems prevention programs .


Training children in social skills and parents in effective discipline are possible mechanisms to divert maladaptive developmental cascades .


We aimed to the addition of synthetic 3-hydroxy-3-methyglutaryl coenzyme A ( HMG-CoA ) reductase inhibitor , simvastatin to capecitabine-cisplatin ( XP ) in patients with previously untreated advanced gastric cancer ( AGC ) .


In this double-blind , placebo-controlled , phase III study , we enrolled patients aged 18 years or older with histological or cytological confirmed metastatic adenocarcinoma of the stomach or gastroesophageal junction ( GEJ ) at nine centres in Korea .


Patients , stratified by disease measurability and participating site , were randomly assigned ( 1:1 ) to receive capecitabine 1000mg/m ( 2 ) twice daily for 14 days and cisplatin 80 mg/m ( 2 ) on day 1 every 3 weeks plus either simvastatin 40 mg or placebo , once daily .


Cisplatin was given for 8 cycles ; capecitabine and simvastatin were administered until disease progression or unacceptable toxicities .


This study is registered with ClinicalTrials.gov , number NCT01099085 .


Between February 2009 and November 2012 , 244 patients were enrolled and assigned to treatment groups ( 120 simvastatin , 124 placebo ) .


Median progression free survival ( PFS ) for 120 patients allocated XP plus simvastatin was 5.2 months ( 95 % confidence interval ( CI ) 4.3-6 .1 ) compared with 4.63 months ( 95 % CI 3.5-5 .7 ) for 124 patients who were allocated to XP plus placebo ( hazard ratio 0.930 , 95 % CI 0.684-1 .264 ; p = 0.642 ) .


63 ( 52.5 % ) of 120 patients in simvastatin group and 70 ( 56.4 % ) of 124 had grade 3 or higher adverse events .


Addition of 40 mg simvastatin to XP does not increase PFS in our trial , although it does not increase toxicity .


Low dose of simvastatin ( 40 mg ) to chemotherapy is not recommended in untargeted population with AGC .


Sensitive troponin ( Tn ) assays have been developed for the evaluation of patients with suspected acute coronary syndrome ( ACS ) .


We sought to compare the performance of a commercially available sensitive Tn I ( sTnI ) and precommercial highly sTnI ( hsTnI ) method to conventional Tn ( cTn ) assays .


Among patients with acute chest pain but normal cTn in the emergency department of 6 centers , sTnI and hsTnI were measured at baseline , 2 and 4 hours after presentation .


Diagnostic accuracy of sTnI and hsTnI relative to cTn for diagnosis during index hospitalization as well as their associations with coronary artery disease in patients randomized to coronary computed tomographic angiography ( CTA ) was assessed .


Overall , 322 patients were enrolled , of whom 161 had a CTA ; 28 had ACS ( 8.7 % ) , including 21 with unstable angina pectoris ( UAP ) .


Both sTnI and hsTnI values at baseline and second draw had significantly higher sensitivity for ACS and UAP than cTn and had significantly greater area under the receiver operator characteristic curve than cTn at first and second draws .


Compared with cTn , 29 % of ACS cases previously categorized as UAP were reclassified to acute myocardial infarction with sTnI or hsTnI .


An hsTnI below limit of detection had 100 % negative predictive value for ACS or significant coronary artery stenosis in those randomized to CTA .


In patients with acute chest discomfort , use of sTnI and hsTnI methods led to significant improvement in the early diagnostic accuracy for ACS , reclassifying one-third of UAP to myocardial infarction .


Very low values for hsTnI excluded underlying coronary artery disease .


To examine whether electric acupuncture can improve the daily life of patients with ischemic cerebral apoplexy at acute stage .


A stratified-block randomized controlled multicenter trial was designed for this study .


Totally 340 patients with acute ischemic cerebral apoplexy were randomly divided into an electric acupuncture group and a control group .


In the electric acupuncture group , 170 patients were treated with electric acupuncture and routine therapy , and 170 patients in the control group with routine therapy alone .


Major indexes for judging curative effect were Barthel index at 3 - and 6 - months follow-up visits and number of re-hospitalized patients .