Bovine herpesvirus type 1 ( BoHV-1 ) is the causative agent of respiratory and genital tract infections ; causing a high economic loss in all continents .


Use of marker vaccines in IBR eradication programs is widely accepted since it allows for protection of the animals against the disease while adding the possibility of differentiating vaccinated from infected animals.The aim of the present study was the development and evaluation of safety and efficacy of a glycoprotein E-deleted ( gE - ) BoHV-1 marker vaccine strain ( BoHV-1gEgal ) generated by homologous recombination , replacing the viral gE gene with the - galactosidase ( gal ) gene .


In vitro growth kinetics of the BoHV-1gEgal virus was similar to BoHV-1 LA. .


The immune response triggered by the new recombinant strain in cattle was characterized both as live attenuated vaccine ( LAV ) and as an inactivated vaccine .


BoHV-1gEgal was highly immunogenic in both formulations , inducing specific humoral and cellular immune responses .


Antibody titers found in animals vaccinated with the inactivated vaccine based on BoHV-1gEgal was similar to the titers found for the control vaccine ( BoHV-1 LA ) .


In the same way , titers of inactivated vaccine groups were significantly higher than any of the LAV immunized groups , independently of the inoculation route ( p < 0.001 ) .


Levels of IFN - were significantly higher ( p < 0.001 ) in those animals that received the LAV compared to those that received the inactivated vaccine .


BoHV-1gEgal exhibited an evident attenuation when administered as a LAV ; no virus was detected in nasal secretions of vaccinated or sentinel animals during the post-vaccination period .


BoHV-1gEgal , when used in either formulation , elicited an efficient immune response that protected animals against challenge with virulent wild-type BoHV-1 .


Also , the deletion of the gE gene served as an immunological marker to differentiate vaccinated animals from infected animals .


All animals vaccinated with the BoHV-1gE gal strain were protected against disease after challenge and shed significantly less virus than control calves , regardless of the route and formulation they were inoculated .


Based on its attenuation , immunogenicity and protective effect after challenge , BoHV-1gEgal virus is an efficient and safe vaccine candidate when used either as inactivated or as live attenuated forms .


To evaluate the clinical efficacy and safety of Qiangji Recipe ( QR ) in ad - junctive treatment of axial undifferentiated spondyloarthritis ( axuSpA ) through a four-week open study .


Fifty-four axuSpA patients of Shen-deficiency Du-channel cold syndrome ( SDDCS ) in line with inclusive criteria were recruited and assigned to the treatment group and the control group according to random digit table , 27 in each group .


Patients in the control group took Celecoxib Capsule ( 0.2 g each time , twice per day ) .


Patients in the treatment group additionally took QR ( consisting of Herba Epimedii 15 g , antler glue 15 g , Cibotium Barometz 15 g , eucommia bark 20 g , dipsacus asper 10 g , two toothed achyranthes root 15 g , drynaria 15 g , Taxillus Chinensis 20 g , ground beetle 10 g , scorpion 5 g , wild celery 10 g , notopterygium incisium 10 g , cow-fat seed 10 g , white mustard seed 6 g , and licorice root 6 g , one dose per day , twice daily ) .


The therapeutic course for all was 4 weeks .


The Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) , the Bath Ankylosing Spondylitis Functional Index ( BASFI ) , the Bath AS Metrology Index ( BASMI ) , total body pain and spinal pain , patient and physician global assessment on a four-point scale , the Ankylosing Spondylitis Quality of Life ( ASQoL ) , erythrocyte sedimentation rate ( ESR ) and C-reactive protein ( CRP ) were measured before and after 4 weeks of treatment .


The primary end point in this study was the proportion of patients with a 20 % improvement response accord - ing to the ASAS International Working Group Criteria ( ASAS 20 responders ) at week 4 .


Totally 50 patients completed this trial , 26 in the treatment group and 24 in the control group .


Improvement of BASDAI , BASFI , BASMI , ASQoL , ESR , and CRP was shown in both groups after treatment .


Better effect was shown in the treatment group in all indices except ESR and BASMI after treatment ( P < 0.05 , P < 0.01 ) .


Twenty cases ( accounting for 76.92 % ) in the treatment group achieved ASAS 20 response at week 4 , while 12 cases ( accounting for 50.00 % ) in the control group achieved ASAS 20 response at week 4 ( P < 0.05 ) .


No obvious adverse reaction occurred in the two groups .


QR combined Celecoxib Capsule showed better effect in treating axuSpA patients than using Celecoxib Capsule alone .


The ` Supporting Teachers And childRen in Schools ' ( STARS ) study is a cluster randomised controlled trial evaluating the Incredible Years Teacher Classroom Management ( TCM ) programme as a public health intervention .


TCM is a 6 day training course delivered to groups of 8-12 teachers .


The STARS trial will investigate whether TCM can improve children 's behaviour , attainment and wellbeing , reduce teachers ' stress and improve their self-efficacy .


This protocol describes the methodology of the process evaluation embedded within the main trial , which aims to examine the uptake and implementation of TCM strategies within the classroom plus the wider school environment and improve the understanding of outcomes .


The STARS trial will work with eighty teachers of children aged 4-9 years from eighty schools .


Teachers will be randomised to attend the TCM course ( intervention arm ) or to `` teach as normal '' ( control arm ) and attend the course a year later .


The process evaluation will use quantitative and qualitative approaches to assess fidelity to model , as well as explore headteachers ' and teachers ' experiences of TCM and investigate school factors that influence the translation of skills learnt to practice .


Four of the eight groups of teachers ( n = 40 ) will be invited to participate in focus groups within one month of completing the TCM course , and again a year later , while 45 of the 80 headteachers will be invited to take part in telephone interviews .


Standardised checklists will be completed by group leaders and each training session will be videotaped to assess fidelity to model .


Teachers will also complete standardised session evaluations .


This study will provide important information about whether the Teacher Classroom Management course influences child and teacher mental health and well-being in both the short and long term .


The process evaluation will provide valuable insights into factors that may facilitate or impede any impact .


The trial has been registered with ISCTRN ( Controlled Trials Ltd ) and assigned an ISRCTN number ISRCTN84130388 .


Date assigned : 15 May 2012 .


The Quality Initiative in Rectal Cancer ( QIRC ) trial targeted surgeon intraoperative technique and not radiation therapy ( RT ) use .


We performed a post hoc analysis of RT use among patients in the QIRC trial , not by arm of trial but rather for the entire group .


We wished to identify associations between local recurrence risk and use of preoperative , postoperative or no RT. .


We compared demographic , tumour and process of care measures among patients receiving preoperative , postoperative or no RT. .


A multivariable Cox regression model assessed local recurrence risk .


The QIRC trial enrolled 1015 patients at 16 hospitals between 2002 and 2004 .


Radiation therapy use did not differ between trial arms , and median follow-up was 3.6 years .


For the preoperative , postoperative and no RT groups , respectively , the percentage of patients was 12.8 % , 19.3 % and 67.9 % ; the percentage of stage II/III tumours was 57.0 % , 88.7 % and 48.1 % ; and the local recurrence rate was 5.3 % , 10.2 % and 5.5 % ( p = 0.05 ) .


After controlling for patient and tumour characteristics , including tumour stage , the hazard ratio ( HR ) for local recurrence was increased in the postoperative RT versus the no RT group ( HR 1.64 , 95 % confidence interval 1.04-2 .58 , p = 0.027 ) .


Use of preoperative RT was low ; most patients with stage II/III disease did not receive RT and , as expected , the postoperative RT group had the highest risk of local recurrence .


Our results suggest opportunities to improve rectal cancer RT use in Ontario .


Levels of platelet reactivity in patients on dual antiplatelet therapy ( DAPT ) can be influenced by concomitant treatment with statins .


We verified if the pharmacodynamic effects of CYP3A4-metabolized statins ( atorvastatin ) and non-CYP3A4-metabolized statins ( pitavastatin ) differ in patients with coronary artery disease ( CAD ) treated with DAPT .


A total of 155 CAD patients receiving DAPT ( clopidogrel 75mg plus aspirin 100mg ) entered the PORTO trial .


Patients were randomly assigned to atorvastatin ( 20mg day ) or pitavastatin ( 4mg day ) for 30 days , and then switched to the other drug for 30 days .


Platelet reactivity was expressed as VerifyNow P2Y12 platelet response units ( PRU ) before and after each 30-day treatment period .


High platelet reactivity was defined as PRU > 208 .


As compared with pretreatment ( 19249 ) , PRU was significantly higher after 30-day atorvastatin ( 21056 ; P = 0.003 ) , but was unchanged after 30-day pitavastatin ( 19947 PRU , NS ) .


In the 48 patients with PRU > 208 at baseline ( 23244 ) , PRU increased significantly after 30-day atorvastatin ( 25841 , P = 0.004 ) , but not after 30-day pitavastatin ( 23743 , NS ) .


In the 107 patients with PRU < 208 at baseline ( 17452 ) , PRU did not change significantly with respect to baseline either after 30-day atorvastatin ( 18861 , NS ) or after 30-day pitavastatin ( 18159 , NS ) .


Pitavastatin , a non-CYP3A4-metabolized statin , does not affect clopidogrel 's response as compared with atorvastatin in patients who are borderline or poor responders to DAPT .


With accumulating knowledge on osteoarthritis development , the next step is to focus on possibilities for primary prevention .


In a 2 2 factorial design , the effects of a diet-and-exercise program and of oral glucosamine sulfate ( double blind and placebo-controlled ) on the incidence of knee osteoarthritis were evaluated in a high-risk group of 407 middle-aged women with a body mass index 27 kg/m ( 2 ) without clinical signs of knee osteoarthritis at baseline ( ISRCTN 42823086 ) .


Primary outcome was the incidence of knee osteoarthritis , defined as Kellgren & Lawrence grade 2 , joint space narrowing of 1.0 mm , or clinical knee osteoarthritis ( clinical and radiographic American College of Rheumatology criteria ) after 2.5 years .


After 2.5 years , only 10 % of all subjects were lost to follow-up , and 17 % of all knees showed incident knee osteoarthritis .


Accounting for the significant interaction between the interventions , no significant main effect of either intervention was found .


Independently , both interventions alone showed indications of reduced knee osteoarthritis incidence ( odds ratio [ OR ] 0.69 ; 95 % CI , 0.39-1 .21 for the diet-and-exercise program and OR 0.60 ; 95 % CI , 0.31-1 .12 for the glucosamine intervention ) .


These effects were neutralized in subjects receiving both interventions ( OR 0.97 ; 95 % CI , 0.55-1 .71 ) .


No significant main effects of the diet-and-exercise program and of glucosamine sulfate were found on incident knee osteoarthritis .


Nevertheless , this trial provides valuable insights for future trial design for preventive osteoarthritis studies .


Sleep disturbances are most prevalent among older adults and often go untreated .


Treatment options for sleep disturbances remain limited , and there is a need for community-accessible programs that can improve sleep .


To determine the efficacy of a mind-body medicine intervention , called mindfulness meditation , to promote sleep quality in older adults with moderate sleep disturbances .


Randomized clinical trial with 2 parallel groups conducted from January 1 to December 31 , 2012 , at a medical research center among an older adult sample ( mean [ SD ] age , 66.3 [ 7.4 ] years ) with moderate sleep disturbances ( Pittsburgh Sleep Quality Index [ PSQI ] > 5 ) .


A standardized mindful awareness practices ( MAPs ) intervention ( n = 24 ) or a sleep hygiene education ( SHE ) intervention ( n = 25 ) was randomized to participants , who received a 6-week intervention ( 2 hours per week ) with assigned homework .


The study was powered to detect between-group differences in moderate sleep disturbance measured via the PSQI at postintervention .


Secondary outcomes pertained to sleep-related daytime impairment and included validated measures of insomnia symptoms , depression , anxiety , stress , and fatigue , as well as inflammatory signaling via nuclear factor ( NF ) - B.


Using an intent-to-treat analysis , participants in the MAPs group showed significant improvement relative to those in the SHE group on the PSQI .


With the MAPs intervention , the mean ( SD ) PSQIs were 10.2 ( 1.7 ) at baseline and 7.4 ( 1.9 ) at postintervention .


With the SHE intervention , the mean ( SD ) PSQIs were 10.2 ( 1.8 ) at baseline and 9.1 ( 2.0 ) at postintervention .


The between-group mean difference was 1.8 ( 95 % CI , 0.6-2 .9 ) , with an effect size of 0.89 .


The MAPs group showed significant improvement relative to the SHE group on secondary health outcomes of insomnia symptoms , depression symptoms , fatigue interference , and fatigue severity ( P < .05 for all ) .


Between-group differences were not observed for anxiety , stress , or NF-B , although NF-B concentrations significantly declined over time in both groups ( P < .05 ) .


The use of a community-accessible MAPs intervention resulted in improvements in sleep quality at immediate postintervention , which was superior to a highly structured SHE intervention .


Formalized mindfulness-based interventions have clinical importance by possibly serving to remediate sleep problems among older adults in the short term , and this effect appears to carry over into reducing sleep-related daytime impairment that has implications for quality of life .


clinicaltrials.gov Identifier : NCT01534338 .


While emergency room ( ER ) studies have documented a strong association of alcohol with injury , these studies are not necessarily representative of the general population .


To evaluate comparative risk of injury from drinking for those treated in the ER with non-ER-treated injuries ( those treated elsewhere or those not treated ) , data on alcohol and injury are analyzed in the U.S. general population by type of injury treatment .


Relative risk ( RR ) of injury from drinking within 6 hours prior to the event was analyzed using case-crossover analysis based on respondents ' usual frequency of drinking in 4 ( 1995 to 2010 ) National Alcohol Surveys ( n = 4,819 ) .


RR was 1.01 for the total injured and significantly elevated for ER-treated injured ( 1.46 ) , but not for those treated elsewhere ( 0.75 ) and those not treated ( 1.02 ) .


RR was significantly elevated for those aged 18 to 30 years ( 1.45 ; 1.14 , 1.85 ) , Blacks ( 1.54 ; 1.11 , 2.14 ) and Hispanics ( 1.98 ; 1.51 , 2.59 ) , those positive on the Rapid Alcohol Problems Screen ( RAPS4 ) as a measure of alcohol dependence ( 2.41 ; 1.86 , 3.11 ) , and for motor vehicle injuries ( 2.61 ; 1.49 , 4.58 ) or cutting/piercing injuries ( 2.04 , 1.10 , 3.81 ) .


For those reporting ER-treated injuries , significant effect modification was found for those aged 18 to 30 years ( RR = 2.29 ) , Blacks ( RR = 2.59 ) and Hispanics ( RR = 2.68 ) , high risk-taking ( RR = 1.71 ) , positive RAPS4 ( RR = 3.69 ) , and for motor vehicle ( RR = 3.79 ) and cutting/piercing injuries ( RR = 2.60 ) .


Data suggest alcohol plays a larger role in injuries for which ER treatment is sought than for other injuries , and estimates for injury from drinking derived from ER studies may be elevated .


Future general population studies should take into account intensity of exposure to alcohol prior to injury , potential recall bias ( by eliciting data on the proximity of injury to time of the respondent interview ) and severity of injury , for improving estimates of the attributable burden of alcohol to injury in society .


To compare the astigmatism-reducing effect of an aspheric toric intraocular lens ( IOL ) and an aspheric nontoric IOL with an opposite clear corneal incision ( OCCI ) in cataract surgery .


Vienna Institute for Research in Ocular Surgery , Hanusch Hospital , Vienna , Austria .


Prospective randomized clinical study .


Patients with low to moderate corneal astigmatism scheduled for cataract surgery received an aspheric toric IOL ( Lentis L-312T ) or an aspheric nontoric IOL ( Lentis L-312 ) combined with an OCCI .


Keratometry and corneal tomography were performed 1 hour , 1 week , 3 months and 9 months postoperatively .


Postoperative residual astigmatism was measured using an autorefractor .


Rotational toric IOL stability was analyzed using retroillumination photography .


Fifty-five patients were included .


Three months postoperatively , the mean reduction in corneal astigmatism was 0.67 diopter ( D ) 0.58 ( SD ) in the toric group and 0.18 0.52 D in the nontoric-OCCI group .


The mean uncorrected distance visual acuity was 0.29 0.30 logMAR and 0.09 0.18 logMAR , respectively ( P = .02 ) .


The mean refractive astigmatism was 1.02 0.54 D and 0.68 0.52 D , respectively ( P = .05 ) .


One hour , 3 months , and 9 months postoperatively , the mean absolute IOL misalignment of toric IOLs was 4.99 4.66 degrees , 13.59 11.29 degrees , and 19.90 14.48 degrees , respectively .


The toric IOL tended to rotate significantly postoperatively .


Visual acuity was good in both groups .


Residual refractive cylinder was significantly lower in the toric IOL group .


No author has a financial or proprietary interest in any material or method mentioned .


Randomized , double-blind , crossover , sham-controlled trial .


Repetitive transcranial magnetic stimulation ( rTMS ) over the primary motor cortex ( M1 ) leads to a significant reduction of spasticity in subjects with spinal cord injury ( SCI ) , but the physiological basis of this effect is still not well understood .


The purpose of this study was to evaluate the disynaptic reciprocal Ia inhibition of soleus motoneurons in SCI patients .


Department of Neurology , Merano , Italy and TMS Laboratory , Paracelsus Medical University , Salzburg , Austria .


Nine subjects with incomplete cervical or thoracic SCI received 5 days of daily sessions of real or sham rTMS applied over the contralateral M1 .


We compared the reciprocal inhibition , the Modified Ashworth Scale and the Spinal Cord Injury Assessment Tool for Spasticity at baseline , after the last session and 1 week later in the real rTMS and sham stimulation groups .


We found that real rTMS significantly reduced lower limb spasticity and restored the impaired excitability in the disynaptic reciprocal inhibitory pathway .


In a small proof-of-concept study , rTMS strengthened descending projections between the motor cortex and inhibitory spinal interneuronal circuits .


This reversed a defect in reciprocal inhibition after SCI , and reduced leg spasticity .


A controlled , clinical , double-blind study was conducted to assess the efficacy of sugar-free tablets containing zinc lactate and magnolia bark extract ( MBE ) on oral volatile sulfur-containing compounds ( VSC ) versus placebo tablets for two hours .


In order to join the study , subjects had to have at least 24 teeth , no report of oral and systemic diseases , and no removable dentures .


All 128 eligible participants had to avoid any professional oral hygiene , refrain from taking medicines for two weeks , be not menstruating , and not brush their teeth and tongue , smoke , drink alcohol , coffee or tea , eat onion , garlic , or licorice for a six-hour period before the visit and during the test .


Moreover , to join the protocol , they had to show a VSC score of 75 ppb at the baseline measurement .


Each qualified subject was placed in the test or the control group using a table of random numbers .


The test tablet ( 0.7 g ) contained 0.17 mg of zinc , in the form of zinc lactate , and 0.84 mg magnolia bark extract ; the control tablet was identical , but without these active agents .


The OralChroma2 device was utilized to evaluate total oral VSC .


Their levels were recorded at baseline , after eight minutes of sucking two tablets in succession , after one hour , and after two hours .


Data were analyzed with SPSS software and the level of significance was set at = 0.05 .


One hundred subjects completed the trial ( 50 in the control group and 50 in the test group ) ; 52 men and 48 women , mean age 38 .


None reported problems linked to zinc lactate or magnolia bark extract .


The mean percentage reduction from baseline at the end of eight minutes of tablet sucking was 39 % in the control group ( p < 0.001 ) and 62 % in the test group ( p < 0.001 ) ; one hour later it was 6 % in the control group and 30 % in the test group ( p < 0.001 ) , and two hours later it was 2 % in the control group and 18 % in the test group ( p < 0.001 ) .


The comparisons between the two groups after baseline adjustment showed a statistically significant difference in reductions of VSC between the test and the control tablets at the end of the sucking period ( p < 0.01 ) , after one hour ( p < 0.001 ) , and after two hours ( p < 0.05 ) .


Tablets containing zinc lactate and magnolia bark extract can statistically significantly reduce the oral VSC levels for over two hours and were statistically significantly more effective than a control tablet .


Cognitive impairment is integral to many neurological illnesses .


Specific enhancement of glutamatergic transmission may improve memory and learning .


Org 25935 increases the synaptic availability of glycine , an obligate co-agonist with glutamate at N-methyl-D-aspartate receptors .


We hypothesised that Org 25935 would acutely improve the learning and memory of healthy volunteers .


A randomised , double-blind , parallel-group , single-dose study of Org 25935 and placebo was carried out .


Thirty-two healthy male volunteers took either 12-mg Org 25935 or matching placebo and were later assessed with the manikin task , digit span and verbal memory tests .


Systematic assessments of cardiovascular and adverse events were also taken .


There was no effect of Org 25935 on reaction time , number of correct responses or learning ( greater or slower improvement over successive tasks ) compared with placebo .


Org 25935 caused significantly more dizziness and drowsiness compared with placebo ; these side effects were mainly mild .


A single dose of Org 25935 does not improve learning or memory in healthy male individuals .


However , the drug was well tolerated , and it remains to be seen whether it would have a positive effect on cognition in patient groups with pre-existing cognitive deficits .


The American College of Emergency Physicians and the American Society of Clinical Oncology recommend early palliative care consultation for patients with advanced , life-limiting illnesses , such as metastatic cancer .


The objectives were to assess the process of early referral from the emergency department ( ED ) to palliative care for patients with advanced , incurable cancer as part of a randomized controlled trial and to compare the proportion and timing of consultation to a care as usual group .


A single-blind randomized controlled trial ( ClinicalTrials.gov ID NCT01358110 ) compared early , ED-based referrals to palliative care for patients admitted with advanced , incurable cancer to physician-driven consultation ( i.e. , care as usual ) .


Participants had to speak English or Spanish and have no history of palliative care consultation .


They were randomized via balanced block randomization to the intervention or control group .


Each intervention subject was referred by a research staff member to the palliative care team for consultation .


The usual care group received palliative care only if requested by the admitting physician .


Analysis was based on intention to treat .


A chart review was performed to assess proportion and timing of palliative care consults during the index admission , defined as : ( 1 ) completed palliative care consult documented in the chart and ( 2 ) days from admission to palliative care consult .


A total of 134 participants were enrolled and randomized .


For patients in the intervention group , 88 % ( 60 of 68 ) had documented palliative care consultations during their index admissions ( 95 % confidence interval [ CI ] = 80.5 to 95.5 ) , compared to 18 % ( 12 of 66 ) in the control group ( 95 % CI = 8.8 to 27.5 ; p < 0.01 ) .


The 60 intervention patients received palliative care consultations on average 1.48 days from admission ( 95 % CI = 1.19 to 1.76 ) , compared to 2.9 days from admission in the 12 control patients ( 95 % CI = 1.03 to 4.79 ; p = 0.15 ) .


This study documented a low baseline rate of palliative care involvement as part of usual care in patients with advanced cancer being admitted from the ED .


Early referral to palliative care in the context of a research study significantly increased the likelihood that patients received a consult , thus meriting further investigation of how to generalize this approach .


Brief postsurgical electrical stimulation ( ES ) has been shown to enhance peripheral nerve regeneration in animal models following axotomy and crush injury .


However , whether this treatment is beneficial in humans with sensory nerve injury has not been tested .


The goal of this study was to test the hypothesis that ES would enhance sensory nerve regeneration following digital nerve transection compared to surgery alone .


Patients with complete digital nerve transection underwent epineurial nerve repair .


After coaptation of the severed nerve ends , fine wire electrodes were implanted before skin closure .


Postoperatively , patients were randomized to receiving either 1 hour of 20Hz continuous ES or sham stimulation in a double-blinded manner .


Patients were followed monthly for 6 months by a blinded evaluator to monitor physiological recovery of spatial discrimination , pressure threshold , and quantitative small fiber sensory testing .


Functional disability was measured using the Disability of Arm , Shoulder , and Hand questionnaire .


A total of 36 patients were recruited , with 18 in each group .


Those in the ES group showed consistently greater improvements in all sensory modalities by 5 to 6 months postoperatively compared to the controls .


Although there was a trend of greater functional improvements in the ES group , it was not statistically significant ( p > 0.01 ) .


Postsurgical ES enhanced sensory reinnervation in patients who sustained complete digital nerve transection .


The conferred benefits apply to a wide range of sensory functions .


A ready-to-use betamethasone valerate 0.1 % ( BMV ) dressing was found to be superior to placebo dressing and a reference 0.1 % BMV cream in the treatment of patients with chronic plaque psoriasis ( CPP ) .


This multicentre , prospective , randomized , investigator-blinded , controlled , non-inferiority trial compared the efficacy and safety of the BMV dressing to the calcipotriol-betamethasone dipropionate ( CBD ) ointment during a 4-week treatment of patients with mild to moderate CPP .


The primary efficacy endpoint was the 4-item psoriasis total severity score ( TSS-4 ) at week 4 , and the associated non-inferiority margin was 1 point .


Secondary outcome measures included the psoriasis global assessment ( PGA ) score and patients ' quality of life ( QoL ) .


Safety was assessed through adverse events ( AE ) reporting in each treatment group .


Of 325 screened patients , 324 were randomized to BMV ( N = 165 ) or CBD ( N = 159 ) , and were considered evaluable for the safety and intention-to-treat ( ITT ) efficacy analyses .


Per protocol ( PP ) populations included 133 and 131 patients in the BMV and CBD groups respectively .


The mean adjusted TSS-4 significantly decreased through the study from baseline in both groups .


The PP ( primary ) analysis of week 4 data revealed a -0.288 ( 95 % CI : -0.610 to 0.034 ) not significant between-group difference in adjusted means , demonstrating non-inferiority of BMV to CBD .


Non-inferiority was also demonstrated in the ITT analysis .


The PGA and other secondary outcomes were significantly improved from baseline in both groups at week 4 .


The QoL score was slightly better in the CBD group at week 4 , but no difference was observed at follow-up .


No safety or tolerability concerns were observed in either group .


BMV dressing is non-inferior to CBD ointment in patients with mild to moderate CPP .


Both treatments significantly improve patients ' psoriasis and QoL .


Camera eye in the McGrath video-laryngoscope blade is located closer to the larynx , which may allow reduction of the head-neck movement during laryngoscopy compared with a conventional laryngoscope .


We compared the degree of head extension during laryngoscopy with McGrath laryngoscope and that with Macintosh laryngoscope .


Fifty patients without cervical spine abnormality were randomized into two groups : laryngoscopies with Macintosh laryngoscope and that with McGrath laryngoscope .


Each patient wearing goggles mounted with a goniometer lay supine with the head in the neutral position .


After general anesthesia and muscle relaxation were obtained an experienced anesthesiologist obtained the best glottic view using either laryngoscope , and change in the angle of goggles ( head extension angle ) during laryngoscopy was measured .


In addition , we compared the head extension angle with extension angle of the cervical spine between the occiput and the fourth cervical vertebra ( C0-4 ) measured radiologically in 7 healthy volunteers .


Head extension angles with Macintosh and McGrath laryngoscopes were 18.2 4.3 degrees and 9.6 2.7 degrees , respectively ( P < 0.0001 ) .


There was a strong relationship between head extension angle and C0-4 extension angle measured radiologically in the volunteers ( r = 0.92 , P < 0.0001 ) .


The McGrath laryngoscope may be a reasonable technique of choice for intubation when minimal cervical spine movement is indispensable because of reduction of head extension during laryngoscopy compared with the conventional laryngoscopy .


To assess short-term efficacy and safety of desvenlafaxine 50 and 100 mg/d versus placebo for treating major depressive disorder ( MDD ) .


Assessment of sexual function was a secondary objective .


Outpatients ( 18 years ) who met criteria for MDD from the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , Text Revision and had screening and baseline 17-item Hamilton Depression Rating Scale ( HDRS17 ) total scores 20 were randomly assigned to placebo or desvenlafaxine 50 or 100 mg/d in an 8-week study conducted from October 2011 to August 2012 .


The primary efficacy end point was change from baseline in HDRS17 total score at week 8 , analyzed using a mixed-effects model for repeated measures .


Sexual function was assessed using the Arizona Sexual Experiences Scale ( ASEX ) .


The safety population included 909 patients ( intent-to-treat population , n = 886 ) .


Significantly greater improvement in adjusted mean HDRS17 total score from baseline to week 8 was observed for desvenlafaxine 50 mg ( -11.28 ; P = .006 ) and desvenlafaxine 100 mg ( -11.67 ; P < .001 ) compared with placebo ( -9.71 ) , with adjustment for multiplicity .


In the ASEX total score analysis ( n = 422 ) , the treatment by gender interaction was not significant ; thus , genders were combined for subsequent analyses .


Comparisons for desvenlafaxine versus placebo for change from baseline in ASEX total and all item scores found P > .05 , with no adjustment for multiplicity .


Rates of sexual dysfunction based on ASEX were comparable among treatment groups .


These results support previous findings demonstrating antidepressant efficacy , safety , and tolerability of desvenlafaxine 50 and 100 mg/d versus placebo .


Sexual function was comparable between desvenlafaxine and placebo .


ClinicalTrials.gov identifier : NCT01432457 .


Rapid and early virological responses to peginterferon-alpha and ribavirin are predictive of sustained virological response ( SVR ) in hepatitis C virus ( HCV ) infection .


We aimed at finding a simple rule to determine the shortest duration of dual therapy for all HCV genotypes , obtained by multiplying time to Initial Viral Response , IVR ( first undetectable HCV-RNA ) by 4 ( Tailored Therapy-4 , or TT4 ) .


267 nave HCV-infected patients with compensated liver disease were randomized ( 2:1 ) to the TT4 ( n = 180 ) or current standard-of-care ( SoC , n = 87 ) and received peginterferon-alpha plus ribavirin .


Patients with HCV-RNA decrease 2log10 at week 12 or detectable HCV-RNA at week 24 discontinued treatment .


Both groups had comparable baseline characteristics , SVR rates were similar in the whole population ( 60.6 % vs. 60.9 % ) and within each genotype subgroup ( G1 : 46.6 % vs. 55.6 % ; G2 : 90.2 % vs. 94.4 % ; G3 : 74.1 % vs. 58.3 % ; G4 : 45.8 % vs. 33.3 % ) .


Relapse rate was higher in G1-TT4 than G1-SoC .


Treatment duration in SVR patients was shorter in TT4 compared to SoC , both overall [ 2515 vs. 3612.1 weeks ] , and for subgroups : G1 [ 35.316.7 vs. 47.32.6 weeks ] , G2 [ 18.37.5 vs. 242.8 weeks ] , G3 [ 15.28.7 vs. 22.83 weeks ] and G4 [ 26.913 vs. 48 weeks ] .


In HCV-naive patients , TT4-rule treatment yields similar SVR rates compared to SoC but with shorter treatment duration and remarkable cost reduction .


To determine the efficacy of stress urinary incontinence treatments adding pelvic floor muscle training to vaginal electrical stimulation .


Forty-eight women with stress urinary incontinence were randomized into 2 groups : 24 underwent isolated vaginal electrical stimulation , and 24 vaginal electrical stimulation plus pelvic floor muscle training .


History , physical examination , voiding diary , perineum strength test , and urodynamic study were assessed .


Comparisons were made for adherence to treatment , muscle strength improvement , urinary symptoms , and degree of satisfaction immediately , 12 and 96 months after treatment .


Patients ' degree of satisfaction on vaginal electrical stimulation , and on vaginal electrical stimulation plus pelvic floor muscle training immediately , 12 and 96 months post treatment , were , respectively : 88.2 % versus 88.9 % 64.7 % versus 61.1 % and 42.9 % versus 28.6 % ( p > 0.05 ) .


Vaginal electrical stimulation associated to pelvic floor muscle training did not show better results than vaginal electrical stimulation alone .


To evaluate and compare the efficacy of vaginal misoprostol and a rectal nonsteroidal anti-inflammatory drug ( NSAID ) on pain relief during Pipelle endometrial biopsies in a placebo-controlled randomized study .


One hundred and fifty-one women who had an indication for a Pipelle endometrial biopsy were randomized into three groups as follows : group 1 , vaginal misoprostol ; group 2 , rectal NSAID , and group 3 , control .


After the procedure , the women were asked to record their pain severity on a visual analog scale .


The secondary outcome of the study was patient acceptability , and vasovagal symptoms and analgesic requirements after the procedure were also recorded .


There were no statistically significant differences in the demographic characteristics of the patients .


The primary study outcome was the comparison of the median visual analog scale pain scores of groups 1 and 2 versus group 3 ( controls ) ; no statistically significant differences were found ( p = 0.502 ) .


In addition , the patient acceptability ( Likert scale ) , vasovagal symptoms and analgesic requirements after the procedure were similar among the groups ( p = 0.204 , 1 and 0.546 , respectively ) .


Our study did not demonstrate a reduction in pain relief during Pipelle endometrial biopsies for patients receiving vaginal misoprostol or a rectal NSAID when compared to patients receiving placebo treatment .


Bronchiolitis is a public health problem in the word and in Tunisia .


Nebulized hypertonic saline seems to have some benefits in bronchiolitis .


The aim of this study is to evaluate the efficacy of nebulized 5 % hypertonic saline alone or mixed with epinephrine in bronchiolitis as measured by improvement in clinical score , oxygen saturation or reduction in duration of hospitalization .


This prospective , double blind , placebo controlled , randomized clinical trial was performed at Children 's Hospital of Tunis from February 2012 to Mars 2012 .


A total of 94 patients less than 12 months of age with diagnosis of moderately severe bronchiolitis were enrolled and assigned to receive 5 % nebulized hypertonic saline , mixed 5 % hypertonic saline with standard epinephrine 0,1 % or normal saline ( placebo ) at admission and every 4 hours during hospitalization .


There were no significant difference between nebulized 5 % hypertonic saline , mixed 5 % hypertonic saline with epinephrine or normal saline at baseline , T30 min , T60 min , and T120 min after start study in Wang severity score , oxygen saturation in room air , rate respiratory and heart rate .


There was no difference in duration of hospitalization .


Nebulized 5 % hypertonic saline or mixed 5 % hypertonic saline with epinephrine are safety but does not appear effective in treating moderately ill infants with the first acute bronchiolitis .


Physical exercise and a Mediterranean diet improve serum lipid profile .


The present work studied whether red wine has an effect on top of a lipid-lowering lifestyle in patients with carotid atherosclerosis .


A prospective randomised unblinded trial was performed from 2009 to 2011 in 108 patients with carotid atherosclerosis , 65 % of whom were already on statin therapy with a low mean LDL of 104.9 mg/dl .


Half of them were advised to follow a modified Mediterranean diet and to perform moderate physical exercise during 30 min/day ( lifestyle changes ) for 20 weeks .


Within these two groups half of the patients were randomised either to avoid any alcohol or to drink 100 ml of red wine ( women ) or 200 ml of red wine ( men ) daily .


LDL was significantly lowered by 7 % in the lifestyle-changes group compared to the no-lifestyle-changes group ( p = 0.0296 ) after 20 weeks .


Lifestyle changes lowered the LDL/HDL ratio after 20 weeks by 8 % ( p = 0.0242 ) and red wine independently by 13 % ( p = 0.0049 ) .


The effect on LDL/HDL ratio after 20 weeks was , however , more pronounced in the non-LC group .


Total cholesterol ( -6 % ; p = 0.0238 ) and triglycerides ( -13 % ; p = 0.0361 ) were lowered significantly by lifestyle changes after 20 weeks compared to the no-lifestyle-changes group .


Lipoprotein ( a ) was not significantly affected by any intervention .


The given results are per ITT analysis .


Lifestyle changes including a modified Mediterranean diet and physical exercise as well as a glass of red wine daily improve independently the LDL/HDL ratio in patients with carotid arteriosclerosis even though the vast majority of them was already on statin therapy .


Patients with non-small-cell lung cancer ( NSCLC ) and ALK rearrangements generally have a progression-free survival of 8-11 months while on treatment with the ALK inhibitor crizotinib .


However , resistance inevitably develops , with the brain a common site of progression .


More potent ALK inhibitors with consistently demonstrable CNS activity and good tolerability are needed urgently .


Alectinib is a novel , highly selective , and potent ALK inhibitor that has shown clinical activity in patients with crizotinib-naive ALK-rearranged NSCLC .


We did a phase 1/2 study of alectinib to establish the recommended phase 2 dose of the drug and examine its activity in patients resistant or intolerant to crizotinib .


We enrolled patients with ALK-rearranged NSCLC who progressed on or were intolerant to crizotinib .


We administered various oral doses of alectinib ( 300-900 mg twice a day ) during the dose-escalation portion of the study ( phase 1 ) , to ascertain the recommended dose for phase 2 .


We used Response Evaluation Criteria in Solid Tumors criteria ( version 1.1 ) to investigate the activity of alectinib in all patients with a baseline scan and at least one post-treatment scan ( CT or MRI ) , with central radiological review of individuals with brain metastases .


We assessed safety in all patients who received at least one dose of alectinib .


Here , we present data for the phase 1 portion of the study , the primary objective of which was to establish the recommended phase 2 dose ; phase 2 is ongoing .


This trial is registered at ClinicalTrials.gov , number NCT01588028 .


47 patients were enrolled .


Alectinib was well tolerated , with the most common adverse events being fatigue ( 14 [ 30 % ] ; all grade 1-2 ) , myalgia ( eight [ 17 % ] ; all grade 1-2 ) , and peripheral oedema ( seven [ 15 % ] grade 1-2 , one [ 2 % ] grade 3 ) .


Dose-limiting toxic effects were recorded in two patients in the cohort receiving alectinib 900 mg twice a day ; one individual had grade 3 headache and the other had grade 3 neutropenia .


The most common grade 3-4 adverse events were increased levels of - glutamyl transpeptidase ( two [ 4 % ] ) , a reduction in the number of neutrophils ( two [ 4 % ] ) , and hypophosphataemia ( two [ 4 % ] ) .


Three patients reported four grade 4 serious adverse events that were deemed unrelated to alectinib : acute renal failure ; pleural effusion and pericardial effusion ; and brain metastasis .


At data cut-off ( median follow-up 126 days [ IQR 84-217 ] ) , 44 patients could be assessed for activity .


Investigator-assessed objective responses were noted in 24 ( 55 % ) patients , with a confirmed complete response in one ( 2 % ) , a confirmed partial response in 14 ( 32 % ) , and an unconfirmed partial response in nine ( 20 % ) .


16 ( 36 % ) patients had stable disease ; the remaining four ( 9 % ) had progressive disease .


Of 21 patients with CNS metastases at baseline , 11 ( 52 % ) had an objective response ; six ( 29 % ) had a complete response ( three unconfirmed ) and five ( 24 % ) had a partial response ( one unconfirmed ) ; eight ( 38 % ) patients had stable disease and the remaining two ( 10 % ) had progressive disease .


Pharmacokinetic data indicated that mean exposure ( AUC0-10 ) after multiple doses of alectinib ( 300-600 mg twice a day ) was dose-dependent .


Alectinib was well tolerated , with promising antitumour activity in patients with ALK-rearranged NSCLC resistant to crizotinib , including those with CNS metastases .


On the basis of activity , tolerability , and pharmacokinetic data , we chose alectinib 600 mg twice a day as the recommended dose for phase 2 .


Chugai Pharmaceuticals , F Hoffmann La-Roche .


We assessed long-term mortality and hospitalisation in patients with severe sepsis resuscitated with hydroxyethyl starch ( HES ) or Ringer 's acetate .


This was an investigator-initiated , parallel-grouped , blinded randomised trial using computer-generated allocation sequence and centralised allocation data that included 804 patients with severe sepsis needing fluid resuscitation in 26 general intensive care units ( ICUs ) in Scandinavia .


Patients were allocated to fluid resuscitation using either 6 % HES 130/0 .42 or Ringer 's acetate during ICU admission .


We assessed mortality rates at 6 months , 1 year and at the time of longest follow-up and days alive and out of hospital at 1 year .


The vital status of all patients was obtained at a median of 22 ( range 13-36 ) months after randomisation .


Mortality rates in the HES versus Ringer 's groups at 6 months were 53.3 ( 212/398 patients ) versus 47.5 % ( 190/400 ) [ relative risk 1.12 ; 95 % confidence interval ( CI ) 0.98-1 .29 ; P = 0.10 ] , respectively ; at 1 year , 56.0 ( 223/398 ) versus 51.5 % ( 206/400 ) ( 1.09 ; 95 % CI 0.96-1 .24 ; P = 0.20 ) , respectively ; at the time of longest follow-up , 59.8 ( 238/398 ) versus 56.3 % ( 225/400 ) ( 1.06 ; 95 % CI 0.94-1 .20 ; P = 0.31 ) , respectively .


Percentage of days alive and out of hospital at 1 year in the HES versus Ringer 's groups was 24 ( 0-87 days ) versus 63 % ( 0-90 ) ( P = 0.07 ) .


The long-term mortality rates did not differ in patients with severe sepsis assigned to HES 130/0 .42 versus Ringer 's acetate , but we could not reject a 24 % relative increased or a 4 % relative decreased mortality at 1 year with HES at the 95 % confidence level .


Titrating the dosage of growth hormone ( GH ) to serum levels of insulin-like growth factor-I ( IGF-I ) is a feasible treatment strategy in children with GH deficiency ( GHD ) and idiopathic short stature ( ISS ) .


The objective was to assess the dose-sparing effect and theoretical safety of IGF-I-based GH therapy .


This was a post hoc analysis of a previously described 2-year , multicenter , open-label , randomized , outpatient , controlled clinical trial in 172 prepubertal short children [ age 75 24 years ; height standard deviation score ( HSDS ) -264 061 ] classified by baseline peak GH levels as GHD ( < 7 ng/ml ) or ISS ( 7 ng/ml ) .


Conventional weight-based dosing of GH ( 004 mg/kg/day ) ( n = 34 ) or GH dosing titrated to an IGF-I target of 0 SDS ( IGF0T ; n = 70 ) or an IGF-I target of +2 SDS ( IGF2T ; n = 68 ) .


Change in HSDS per GH mg/kg/day dose ( HSDS/GH dose ratio ) and proportion of IGF-I levels above +2 SDS at the end of 2 years .


GH dosing titrated to an IGF-I target of 0 SDS was the most dose-sparing treatment regimen for GHD or ISS children ( meanSE HSDS/GH dose ratios 481 44 and 325 28 , respectively ) compared with conventional dosing ( 303 66 and 213 35 , respectively ; P = 002 , P = 0005 ) and IGF2T ( 327 48 and 163 28 , respectively ; P = 002 , P < 00001 ) .


IGF0T also resulted in the fewest IGF-I excursions above +2 SDS ( 68 % vs 300 % for conventional dosing ; P < 001 ) .


IGF-I-based GH dosing , targeted to age - and gender-adjusted means , may offer a more dose-sparing and potentially safer mode of therapy than traditional weight-based dosing .


To compare the clinical benefit of a periodontal dressing applied after a one-stage full-mouth disinfection ( OSFMD ) in patients with chronic periodontitis up to 3months after therapy .


This randomized , controlled split-mouth study included 24 patients .


After OSFMD , a test and a control side were selected by means of a computer-generated randomization list .


Test sides received a periodontal dressing ( Coepak ( ) ) for 7days and the control sides received no periodontal dressing .


After 7days the periodontal dressing was removed and the pain experience was recorded .


After 3months , the clinical periodontal parameters were recorded .


The periodontal dressing group showed a significant ( p < 0.05 ) additional pocket depth reduction and additional clinical attachment gain for the moderate pockets of single - and multi-rooted teeth compared with the control group .


A significant ( p < 0.05 ) lower percentage of sites with probing pocket depth 5mm were shown for the periodontal dressing group compared with the control group ( 2.716.3 % versus 4.821.4 % ) .


The pain intensity was significantly reduced when using a periodontal dressing ( 5.130.89 versus 3.421.27 ) .


The use of a periodontal dressing for 7days after a OSFMD offers an additional short-term clinical improvement and lowers the pain intensity .


It was hypothesized that a mobile health ( mHealth ) intervention would elicit greater improvements in systolic blood pressure and other cardiometabolic risk factors at 12weeks , which would be better maintained over 52weeks , compared to the active control intervention .


Eligible participants ( 2 metabolic syndrome risk factors ) were randomized to the mHealth intervention ( n = 75 ) or the active control group ( n = 74 ) .


Blood pressure and other cardiometabolic risk factors were measured at baseline and at 12 , 24 and 52weeks .


Both groups received an individualized exercise prescription and the intervention group additionally received a technology kit for home monitoring of biometrics and physical activity .


Analyses were conducted on 67 participants in the intervention group ( aged 56.79.7 years ; 71.6 % female ) and 60 participants in the active control group ( aged 59.18.4 years ; 76.7 % female ) .


At 12weeks , baseline adjusted mean change in systolic blood pressure ( primary outcome ) was greater in the active control group compared to the intervention group ( -5.68 mmHg ; 95 % CI -10.86 to -0.50 mmHg ; p = 0.03 ) , but there were no differences between groups in mean change for secondary outcomes .


Over 52-weeks , the difference in mean change for systolic blood pressure was no longer apparent between groups , but remained significant across the entire population ( time : p < 0.001 ) .


In participants with increased cardiometabolic risk , exercise prescription alone had greater short-term improvements in systolic blood pressure compared to the mHealth intervention , though over 52weeks , improvements were equal between interventions .


ClinicalTrials.gov http://NCT01944124 .


Physicians play a critical role in addressing tobacco dependence , yet report limited training .


Tobacco dependence treatment curricula for medical students could improve performance in this area .


This study identified student and medical school tobacco treatment curricula characteristics associated with intentions and use of the 5As for tobacco treatment among 3rd year U.S. medical students .


Third year medical students ( N = 1065 , 49.3 % male ) from 10 U.S. medical schools completed a survey in 2009-2010 assessing student characteristics , including demographics , tobacco treatment knowledge , and self-efficacy .


Tobacco curricula characteristics assessed included amount and type of classroom instruction , frequency of tobacco treatment observation , instruction , and perception of preceptors as role models .


Greater tobacco treatment knowledge , self-efficacy , and curriculum-specific variables were associated with 5A intentions , while younger age , tobacco treatment self-efficacy , intentions , and each curriculum-specific variable were associated with greater 5A behaviors .


When controlling for important student variables , greater frequency of receiving 5A instruction ( OR = 1.07 ; 95 % CI 1.01-1 .12 ) and perception of preceptors as excellent role models in tobacco treatment ( OR = 1.35 ; 95 % CI 1.04-1 .75 ) were significant curriculum predictors of 5A intentions .


Greater 5A instruction ( B = .06 ( .03 ) ; p < .05 ) and observation of tobacco treatment ( B = .35 ( .02 ) ; p < .001 ) were significant curriculum predictors of greater 5A behaviors .


Greater exposure to tobacco treatment teaching during medical school is associated with both greater intentions to use and practice tobacco 5As .


Clerkship preceptors , or those physicians who provide training to medical students , may be particularly influential when they personally model and instruct students in tobacco dependence treatment .


The aim of the study was to compare the effects of aerobic exercise training and yoga on the functional capacity , peripheral muscle strength , quality of life ( QOL ) , and fatigue in breast cancer survivors .


A total of 52 patients with a diagnosis of breast cancer were included in the study .


The patients were randomly assigned to 2 groups : aerobic exercise ( n = 28 ) and yoga added to aerobic exercise ( n = 24 ) .


Both groups participated in submaximal exercise 30 minutes/d , 3 d/wk for 6 weeks .


The second group participated in a 1-hour yoga program in addition to aerobic exercise training .


Functional capacity was assessed by the 6-Minute Walk Test ( 6MWT ) .


Peripheral muscle strength was evaluated with a hand-held dynamometer .


The fatigue severity level was assessed with the Fatigue Severity Scale ( FSS ) .


The QOL was determined by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire .


There were statistically significant increases in peripheral muscle strength , the 6MWT distance , and the perception of QOL in both groups ( P < .05 ) .


Additionally , the group with aerobic exercise and yoga showed marked improvement compared with the aerobic exercise group in fatigue perception ( P < .05 ) .


According to the data from this study , aerobic exercise training and yoga improved the functional capacity and QOL of breast cancer patients .


Aerobic exercise programs can be supported by body mind techniques , such as yoga , in the rehabilitation of cancer patients for improving functional recovery and psychosocial wellness .


A very high percentage of patients with severe pelvic endometriosis develop adhesions after laparoscopic surgery .


The objective of this trial was to evaluate the role of ovarian suspension performed during surgery for severe endometriosis on ovarian adhesions and postoperative pelvic pain .


A randomized controlled trial ( Canadian Task Force classification I ) .


The tertiary care University Hospital of Bologna , Bologna , Italy .


Eighty patients with ovarian and posterior deep infiltrating endometriosis were included in the study .


Patients underwent laparoscopic surgery for endometriosis and were randomized sequentially into 2 groups : transient ovarian suspension was performed in the treatment group ( n = 40 ) , whereas in the control group ( n = 40 ) ovaries were left free in the pelvis .


Symptom intensity ( dysmenorrhea , chronic pelvic pain , dyspareunia , dyschezia , and dysuria ) were ranked using a visual analog scale .


Postsurgical ovarian adhesions were evaluated using transvaginal ultrasonographic scans performed by an ultrasound operator who was blinded to the details of the operative procedure and women 's randomization allocation .


Complications , lesion localization , endometrioma diameter , and surgery time were recorded .


At follow-up , a significantly lower rate of ultrasound-detectable ovarian adhesions with the uterus and the bowel was observed in the treatment group , respectively ( 46.7 % vs 77.3 % , p = .003 and 26.7 % vs 68.2 % , p < .0005 ) .


Patients in the control group showed a higher percentage of fixed ovaries with moderate and severe adhesions than the treatment group , respectively ( 56.8 % vs 28.9 % , p = .003 and 20.5 % vs 8.9 % , p = .110 ) .


No differences between the 2 groups were found regarding complications and pelvic pain .


Ovarian suspension seems to be an additional effective surgical procedure associated with an increased ovarian mobility in women treated for severe endometriosis .


Moreover , it is feasible , safe , simple , and fast .


Hence , it should be routinely used during laparoscopic surgery for endometriosis .


Insulin therapy should be strongly considered in newly diagnosed type 2 diabetic ( T2D ) patients with severe hyperglycemia .


However , whether insulin be continued or patients switched to an oral antidiabetic drug ( OAD ) after short-term intensive insulin therapy ( ITT ) is not clear .


After ITT for 10-14 days , 47 patients were randomized into either a glargine ( n = 21 ) or metformin-based OAD ( n = 26 ) group for a 6-month intervention .


After these 6 months , patients in the glargine group were switched to metformin-based OAD therapy , whereas treatment in the OAD group was unchanged .


Patients were followed-up for another 6 months .


At the end of the 6-month intervention , HbA1c was similarly reduced in both the glargine ( from 11.811.70 % to 6.480.79 % ; P < 0.001 ) and OAD ( from 11.711.89 % to 6.160.52 % ; P < 0.001 ) groups .


At the end of 12 months , HbA1c was at comparable and near optimal levels in both groups .


Similar increases were seen in homeostatic model assessment of - cell function in the two groups after 6 months .


There were no significant differences between the two groups in insulin sensitivity improvement , hypoglycemic episodes , weight change , treatment satisfaction and quality of life after the 6-month intervention .


The effects of metformin-based OAD therapy on glycemic control and improvements in - cell function are not inferior to glargine in newly diagnosed T2D patients with severe hyperglycemia after short-term ITT .


Considering the superiority of metformin in terms of safety , cost , and convenience , metformin-based OAD therapy is strongly recommended for these patients .


Group psychosocial interventions including mindfulness-based cancer recovery ( MBCR ) and supportive-expressive group therapy ( SET ) can help breast cancer survivors decrease distress and influence cortisol levels .


Although telomere length ( TL ) has been associated with breast cancer prognosis , the impact of these two interventions on TL has not been studied to date .


The objective of the current study was to compare the effects of MBCR and SET with a minimal intervention control condition ( a 1-day stress management seminar ) on TL in distressed breast cancer survivors in a randomized controlled trial .


MBCR focused on training in mindfulness meditation and gentle Hatha yoga whereas SET focused on emotional expression and group support .


The primary outcome measure was relative TL , the telomere/single-copy gene ratio , assessed before and after each intervention .


Secondary outcomes were self-reported mood and stress symptoms .


Eighty-eight distressed breast cancer survivors with a diagnosis of stage I to III cancer ( using the American Joint Committee on Cancer ( AJCC ) TNM staging system ) who had completed treatment at least 3 months prior participated .


Using analyses of covariance on a per-protocol sample , there were no differences noted between the MBCR and SET groups with regard to the telomere/single-copy gene ratio , but a trend effect was observed between the combined intervention group and controls ( F [ 1,84 ] , 3.82 ; P = .054 ; ( 2 ) = .043 ) ; TL in the intervention group was maintained whereas it was found to decrease for control participants .


There were no associations noted between changes in TL and changes in mood or stress scores over time .


Psychosocial interventions providing stress reduction and emotional support resulted in trends toward TL maintenance in distressed breast cancer survivors , compared with decreases in usual care .


To evaluate the influence of perioperative intravenous administration of ambroxol on pulmonary function , postoperative complications , postoperative hospital stay , and cost after video-assisted thoracic surgery lobectomy for lung cancer .


Sixty patients who underwent video-assisted thoracic surgery lobectomy for lung cancer in Xiangya Hospital , Central South University between May 2011 and May 2012 were randomly assigned into 2 groups : An ambroxol group ( n = 30 ) and a control group ( n = 30 ) .


In the ambroxol group , patients were given ambroxol ( 1 000 mg/d ) on the day of operation and on the first 3 postoperative days .


In control group , placebo was given .


The pulmonary function tests , arterial blood gases , incidence of perioperative morbidity , postoperative mechanical ventilation time , duration of ICU stay , length and costs of postoperative hospital stay were compared between the 2 groups .


The 2 groups were well matched for demographics and operative variables .


The ambroxol group showed better the percent predicted forced expiratory volume in 1 second ( FEV1 % ) , the ratio of forced expiratory volume in 1 second to forced vital capacity ( FEV1/FVC % ) , the percent predicted diffusing capacity of the lung for carbon monoxide ( DLCO % ) and arterial oxygen pressure than the control group .


The postoperative pulmonary complications was significantly reduced , the duration of mechanical ventilation and the length of ICU stay were shortened , and the length and costs of postoperative hospital stay were significantly decreased in the ambroxol group compared with the control group ( all P < 0.05 ) .


Perioperative intravenous administration of ambroxol can improve the postoperative lung function , reduce the incidence of pulmonary complications , shorten the length of postoperative hospital stay , and lower the total cost of hospitalization after video-assisted thoracic surgery lobectomy for lung cancer .


Several agents have been tried in the management of mastalgia .


Centchroman ( Ormeloxifene ) , a novel non-steroidal selective estrogen receptor modulator ( SERM ) , has also been recently used in the management of mastalgia .


Eligible patients , who had mastalgia for more than 3 months , were randomized into two groups - Group A received centchroman 30 mg daily and Group B received tamoxifen 10 mg daily .


Treatment was continued for a total of 12 weeks ; thereafter , patients were followed for another 12 weeks without medication to assess the continuum of relief .


Pain severity was measured with VAS score .


Patients were considered to have complete pain relief if their VAS score decreased to 3 or less .


Patients , in both the groups , showed gradual improvement in mastalgia with passage of time up to 12 weeks .


Following cessation of treatment at 12 weeks , partial relapse of pain was observed at 24 weeks .


There was no significant difference between Group A and Group B in terms of mean VAS Score and proportion of women reporting pain relief at 4 , 8 , 12 , and 24 weeks .


Fifteen patients in Group A had side effects namely dizziness , menstrual irregularities and development of ovarian cysts .


There was no side effect noted in group B.


Centchroman and tamoxifen were found to be of similar effectiveness in providing pain relief in mastalgia .


High frequency of side effects , particularly development of ovarian cyst , in patients receiving centchroman is a matter of concern .


Nasoalveolar molding became increasingly popular in the 1990s as a means of easing surgery and improving nasal outcomes for cleft lip repairs .


In the late 1990s , three orthodontists from our center underwent nasoalveolar molding training : two at the Rush Craniofacial Center , in Chicago ; and one at New York University Craniofacial Center .


They brought two different nasoalveolar molding techniques back to Chang Gung Craniofacial Center : the modified Figueroa and the modified Grayson techniques .


Outcomes following use of these techniques have not previously been compared prospectively .


Between May of 2010 and March of 2013 , a randomized , prospective , single-blind trial was conducted to compare the number of clinical visits , total costs , complications , and nasal symmetry between the two nasoalveolar molding techniques in 30 patients with unilateral complete cleft lip .


There were no differences between nasoalveolar molding techniques in the number of clinical visits , total costs , nostril height , or nostril area ratio .


Preoperatively but after nasoalveolar molding , the nostril width ratio was wider for the Figueroa group than for the Grayson group .


Six months after surgical correction , there were no differences in nostril height , nostril width , nasal sill height , or nostril area ratio between nasoalveolar molding methods .


Alveolar ulceration occurred more frequently in the Grayson group .


The modified Grayson technique reduced nostril width more efficiently , but alveolar ulceration was more frequent and no differences in nostril width were found following surgery .


Overall , the two nasoalveolar molding techniques produced similar nasal outcomes .


Therapeutic , II .


This analysis compared the quality-adjusted survival and clinical outcomes of albumin-bound paclitaxel + carboplatin ( nab-PC ) vs solvent-based paclitaxel + carboplatin ( sb-PC ) as first-line therapy in advanced non-small-cell lung cancer ( NSCLC ) in older patients .


Using age-based subgroup data from a randomised Phase-3 clinical trial , nab-PC and sb-PC were compared with respect to overall response rate ( ORR ) , overall survival ( OS ) , progression-free survival ( PFS ) , quality of life ( QoL ) , safety/toxicity , and quality-adjusted time without symptoms or toxicity ( Q-TWiST ) with ages 60 and 70 years as cut points .


Among patients aged 60 years ( N = 546 ) , nab-PC ( N = 265 ) significantly increased ORR and prolonged OS , despite a non-significant improvement in PFS , vs sb-PC ( N = 281 ) .


Nab-PC improved QoL and was associated with less neuropathy , arthralgia , and myalgia but resulted in more anaemia and thrombocytopenia .


Nab-PC yielded significant Q-TWiST benefits ( 11.1 vs 9.8 months ; 95 % CI of gain : 0.2-2 .6 ) , with a relative Q-TWiST gain of 10.8 % ( ranging from 6.4 % to 15.1 % in threshold analysis ) .


In the 70 years age group , nab-PC showed similar , but non-significant , ORR , PFS , and Q-TWiST benefits and significantly improved OS and QoL .


Nab-PC as first-line therapy in older patients with advanced NSCLC increased ORR , OS , and QoL and resulted in quality-adjusted survival gains compared with standard sb-PC .


To test the use of three lead monitoring as a screening tool for atrial fibrillation ( AF ) in general practice .


AF is responsible for up to a quarter of all strokes and is often asymptomatic until a stroke occurs .


26 randomly selected general practices identified 80 randomly selected patients aged 70 or older from their database and excluded those known to have AF , those with clinical issues or who had not attended for three years .


Up to 40 eligible patients/practice were invited to attend for screening .


A 2min three-lead ECG was recorded and collected centrally for expert cardiology assessment .


Risk factor data was gathered .


( i ) point prevalence of AF , ( ii ) proportion of ECG tracings which were adequate for interpretation , ( iii ) uptake rate by patients and ( iv ) acceptability of the screening process to patients and staff ( reported separately ) .


Of 1447 current patients , 1003 were eligible for inclusion , 639 ( 64 % ) agreed to take part in screening and 566 ( 56 % ) completed screening .


The point prevalence rate for AF was 10.3 % -2.1 % new cases ( 12 of 566 who were screened ) and 9.5 % existing cases ( 137 of 1447 eligible patients ) .


Only four of 570 ( 0.7 % ) screening visits did not record a usable ECG and 11 ( 2.6 % ) three lead ECGs required a clarifying 12 lead ECG .


Three lead screening for AF is feasible , effective and offers an alternative to pulse taking or 12 lead ECGs .


The availability of this technology may facilitate more effective screening , leading to reduced stroke incidence .


Prehospital identification of acute stroke increases the possibility of early treatment and good outcome .


To increase identification of stroke , the Face Arm Speech Time ( FAST ) test was introduced in the Emergency Medical Communication Center ( EMCC ) .


This substudy aims to evaluate the implementation of the FAST test in the EMCC and the ambulance service .


The study was conducted in the region of Stockholm , Sweden during 6 months .


The study population consisted of all calls to the EMCC concerning patients presenting at least one FAST symptom or a history/finding making the EMCC or ambulance personnel to suspect stroke within 6 h. Positive FAST was compared to diagnosis at discharge .


Positive predictive values ( PPV ) for a stroke diagnosis at discharge were calculated .


In all , 900 patients with a median age of 71 years were enrolled , 667 ( 74 % ) by the EMCC and 233 ( 26 % ) by the ambulances .


At discharge , 472 patients ( 52 % ) were diagnosed with stroke/transient ischemic attack ( TIA ) , 337 identified by the EMCC ( 71 % ) and 135 ( 29 % ) by the ambulances .


The PPV for a discharge diagnosis of stroke/TIA was 51 % ( CI 47-54 % ) in EMCC-enrolled and 58 % ( CI 52-64 % ) in ambulance-enrolled patients .


With a positive FAST the PPV of a correct stroke/TIA diagnosis increased to 56 % ( CI 52-61 % ) and 73 % ( CI 66-80 % ) in EMCC - and ambulance-enrolled patients , respectively .


Positive FAST from EMCC was also found in 44 % of patients with a nonstroke diagnosis at discharge .


A stroke/TIA diagnosis at discharge but negative FAST was found in 58 and 27 patients enrolled by the EMCC and ambulances , respectively .


The PPV of FAST is higher when used on the scene by ambulance than by EMCC .


FAST may be a useful prehospital tool to identify stroke/TIA but has limitations as the test can be negative in true strokes , can be positive in nonstrokes , and FAST symptoms may be present but not identified in the emergency call .


For the prehospital care situation better identification tools are needed .


Few studies have characterized longer-term outcomes after retropubic and transobturator mid urethral slings .


Women completing 2-year participation in a randomized equivalence trial who had not undergone surgical re-treatment for stress urinary incontinence were invited to participate in a 5-year observational cohort .


The primary outcome , treatment success , was defined as no re-treatment or self-reported stress incontinence symptoms .


Secondary outcomes included urinary symptoms and quality of life , satisfaction , sexual function and adverse events .


Of 597 women 404 ( 68 % ) from the original trial enrolled in the study .


Five years after surgical treatment success was 7.9 % greater in women assigned to the retropubic sling compared to the transobturator sling ( 51.3 % vs 43.4 % , 95 % CI -1.4 , 17.2 ) , not meeting prespecified criteria for equivalence .


Satisfaction decreased during 5 years but remained high and similar between arms ( retropubic sling 79 % vs transobturator sling 85 % , p = 0.15 ) .


Urinary symptoms and quality of life worsened with time ( p < 0.001 ) , and women with a retropubic sling reported greater urinary urgency ( p = 0.001 ) , more negative impact on quality of life ( p = 0.02 ) and worse sexual function ( p = 0.001 ) .


There was no difference in the proportion of women experiencing at least 1 adverse event ( p = 0.17 ) .


Seven new mesh erosions were noted ( retropubic sling 3 , transobturator sling 4 ) .


Treatment success decreased during 5 years for retropubic and transobturator slings , and did not meet the prespecified criteria for equivalence with retropubic demonstrating a slight benefit .


However , satisfaction remained high in both arms .


Women undergoing a transobturator sling procedure reported more sustained improvement in urinary symptoms and sexual function .


New mesh erosions occurred in both arms over time , although at a similarly low rate .


More than 300,000 surgeries are performed annually in the United States for pelvic organ prolapse .


Sacrospinous ligament fixation ( SSLF ) and uterosacral ligament suspension ( ULS ) are commonly performed transvaginal surgeries to correct apical prolapse .


Little is known about their comparative efficacy and safety , and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training ( BPMT ) improves outcomes of prolapse surgery .


To compare outcomes between ( 1 ) SSLF and ULS and ( 2 ) perioperative BPMT and usual care in women undergoing surgery for vaginal prolapse and stress urinary incontinence .


Multicenter , 22 factorial , randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 US medical centers .


Two-year follow-up rate was 84.5 % .


The surgical intervention was transvaginal surgery including midurethral sling with randomization to SSLF ( n = 186 ) or ULS ( n = 188 ) ; the behavioral intervention was randomization to receive perioperative BPMT ( n = 186 ) or usual care ( n = 188 ) .


The primary outcome for the surgical intervention ( surgical success ) was defined as ( 1 ) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen ( anatomic success ) , ( 2 ) no bothersome vaginal bulge symptoms , and ( 3 ) no re-treatment for prolapse at 2 years .


For the behavioral intervention , primary outcome at 6 months was urinary symptom scores ( Urinary Distress Inventory ; range 0-300 , higher scores worse ) , and primary outcomes at 2 years were prolapse symptom scores ( Pelvic Organ Prolapse Distress Inventory ; range 0-300 , higher scores worse ) and anatomic success .


At 2 years , surgical group was not significantly associated with surgical success rates ( ULS , 59.2 % [ 93/157 ] vs SSLF , 60.5 % [ 92/152 ] ; unadjusted difference , -1.3 % ; 95 % CI , -12.2 % to 9.6 % ; adjusted odds ratio [ OR ] , 0.9 ; 95 % CI , 0.6 to 1.5 ) or serious adverse event rates ( ULS , 16.5 % [ 31/188 ] vs SSLF , 16.7 % [ 31/186 ] ; unadjusted difference , -0.2 % ; 95 % CI , -7.7 % to 7.4 % ; adjusted OR , 0.9 ; 95 % CI , 0.5 to 1.6 ) .


Perioperative BPMT was not associated with greater improvements in urinary scores at 6 months ( adjusted treatment difference , -6.7 ; 95 % CI , -19.7 to 6.2 ) , prolapse scores at 24 months ( adjusted treatment difference , -8.0 ; 95 % CI , -22.1 to 6.1 ) , or anatomic success at 24 months .


Two years after vaginal surgery for prolapse and stress urinary incontinence , neither ULS nor SSLF was significantly superior to the other for anatomic , functional , or adverse event outcomes .


Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years .


clinicaltrials.gov Identifier : NCT00597935 .


Minocycline and lymecycline are used in the treatment of acne , but there is not enough evidence to support superior efficacy of one of them .


170 participants from 14 to 34 years old with mild to moderate facial acne vulgaris were recruited .


84 had 100 mg of minocycline in a single daily dose for 8 weeks and 86 had 300 mg of lymecycline in a single daily dose for 8 weeks .


Participants were evaluated at baseline , week 4 and week 8 .


65 minocycline and 60 lymecycline patients were evaluable .


The last observation carried forward for the count of non-inflammatory lesions changed from 37.5 17.8 to 37.7 17.8 in the minocycline group and from 36.9 15.5 to 33.4 19.3 in the lymecycline group ( no significant changes ) ; corresponding changes in inflammatory lesions were from 19.4 12.4 to 12.2 10.0 in the minocycline group and from 20.1 11.3 to 12.6 8.4 in lymecycline group ( P < 0.05 comparing baseline vs. final in both groups ) .


Porphyrin counts varied from 899.5 613.9 to 233.5 219.5 in the minocycline group and from 956.9 661.8 to 411.8 411.5 in the lymecycline group ( P < 0.05 between the groups at study end ) .


36 ( 42.9 % ) patients receiving minocycline suffered 55 adverse events ( 22 of them gastrointestinal ) , while 28 ( 33.3 % ) lymecycline patients had 37 adverse events ( 15 of them gastrointestinal ) .


One patient in the lymecycline group withdrew the study due to gastritis , and one more patient in the same group experienced eosinophilia .


There were no differences between the groups in non-inflammatory and inflammatory lesion counts , and in the safety profile .


Treatment with minocycline induced statistically significant decrease in facial porphyrin counts compared to the group treated with lymecycline ( ClinicalTrials.gov number , NCT00988026 ) .


Experimental studies have shown that liposomal curcumin can exert a reduction in tumor growth in pancreatic and colorectal cancer .


In this phase I clinical trial we investigated the pharmacokinetics , safety , and tolerability of intravenously administered liposomal curcumin in healthy subjects .


50 male and female participants were included in this randomized , placebo-controlled double-blind phase I dose escalation study .


Subjects received a single dose of liposomal curcumin ( 10 - 400 mg/m2 ; n = 2 - 6 per group ) or placebo over 2 hours intravenously .


Dose-dependent increases in the plasma concentrations of curcumin and its metabolite tetrahydrocurcumin ( THC ) were detected .


After the end of drug infusion , curcumin and THC plasma concentrations decreased within 6 - 60 minutes below the limit of quantification .


Mean urinary excretion was ~ 0.1 % of total systemic clearance .


Liposomal curcumin was tolerated well , but a transient red blood cell echinocyte formation with concomitant increase in mean cellular volume was observed at dosages 120 mg/m2 .


Short-term intravenous dosing of liposomal curcumin appears to be safe up to a dose of 120 mg/m2 .


Changes in red blood cell morphology may represent a dose limiting sign of toxicity .


The effectiveness and tolerability of tapentadol extended release ( ER ) , a centrally acting analgesic with - opioid receptor agonist and norepinephrine ( noradrenaline ) reuptake inhibitor activities , have been demonstrated in patients with chronic pain , including those switching directly from prior opioid therapy .


The objective of the current study was to evaluate the effectiveness and safety of conversion to oral tapentadol ER ( 50-250 mg twice daily ) from previous around-the-clock strong opioid therapy in patients with moderate to severe , chronic malignant tumor-related cancer pain that was well-controlled .


This randomized , open-label , phase III study , which was conducted in Japan , included a 1 - to 2-week screening period ( on previous opioid ) and an 8-week , open-label treatment period .


Eligible patients , who were taking a strong opioid analgesic and had a mean pain intensity score < 4 during the 3 days prior to randomization ( adequate pain control on previous strong opioid ) , were randomized ( 1:1 ) to receive twice-daily treatment with tapentadol ER ( 100-500 mg/day ) or morphine sustained release ( SR ; 20-140 mg/day ; reference for assay sensitivity ) .


Initial doses were estimated based on the conversion ratio of tapentadol ER : oxycodone : morphine : fentanyl = 10:2:3:0.03 .


The primary effectiveness endpoint was the proportion of patients who maintained pain control [ change from baseline in mean pain intensity ( 11-point numerical rating scale ) less than +1.5 for 3 consecutive days and no more than two doses of rescue medication per day for 3 consecutive days ) during the first week of open-label treatment .


In the tapentadol ER group ( n = 50 ) , 84.0 % of patients ( 42/50 ; 95 % CI , 70.89-92 .83 ) maintained pain control during Week 1 .


On the Patient Global Impression of Change , 2.1 % ( 1/48 ) , 2.1 % ( 1/48 ) , 22.9 % ( 11/48 ) , and 50.0 % ( 24/48 ) of patients in the tapentadol ER group reported that their overall condition was `` very much improved , '' `` much improved , '' `` minimally improved , '' and `` not changed , '' respectively , at Week 1 compared with 0 % , 10.7 % ( 3/28 ) , 28.6 % ( 8/28 ) , and 53.6 % ( 15/28 ) reporting these ratings at Week 8 .


The sensitivity of effectiveness analyses was validated based on results using morphine SR ; 98.0 % ( 49/50 ; 95 % CI , 89.35-99 .95 ) of patients in the morphine SR group maintained pain control after 1 week of treatment .


The overall safety profile was similar to that demonstrated in previous studies ; tapentadol ER was associated with a lower incidence of gastrointestinal treatment-emergent adverse events than morphine SR [ 38.0 % ( 19/50 ) vs. 54.0 % ( 27/50 ) ] , including constipation [ 12.0 % ( 6/50 ) vs. 20.0 % ( 10/50 ) ] and vomiting [ 6.0 % ( 3/50 ) vs. 26.0 % ( 13/50 ) ] .


Overall , results indicate that conversion from previous strong opioids to tapentadol ER ( 50-250 mg twice daily ) was successful and resulted in safe and effective pain control with improved gastrointestinal tolerability versus morphine SR in patients with moderate to severe cancer-related pain that was well-controlled on their previous opioid .


Antipsychotic drugs frequently cause amenorrhoea and galactorrhoea .


Jasmine flowers used topically were as effective as oral Bromocriptine in suppressing puerperal lactation .


This study aims to evaluate the efficacy and safety of intranasal jasmine flower extract ( JFE ) to reduce prolactin levels of patients on stable doses of antipsychotic drugs .


This is a randomized , double blind , crossover clinical trial .


An aqueous-ethanol extract of jasmine flowers was prepared and used as nasal drops .


A decrease in serum prolactin of 25ng/mL was considered a significant response .


Ten out of 35 women had a significant drop in the serum prolactin while on the JFE .


The non-responders to JFE were on higher doses of antipsychotic drugs .


The main side effect was a transient and mild burning sensation in the nose .


A cost analysis favoured JFE over dopamine agonists .


JFE contains a prolactin-lowering substance which needs further characterisation .


To evaluate the recurrence of common bile duct stones and risk factors for recurrence following routine endoscopic sphincterotomy ( EST ) versus small-incision endoscopic sphincterotomy plus endoscopic papillary balloon dilation ( EST-EPBD ) .


Three hundred patients who were hospitalized between June 2007 and June 2008 with common bile duct stones > 10 mm in diameter were randomly assigned to the EST or EST-EPBD group .


We compared the short-term ( 3 years ) and long-term ( > 3 years ) recurrence of ductal stones in the two groups over a 72-month follow-up period .


Potential risk factors were evaluated using a logistic regression analysis .


A total of 291 patients completed the study .


The short-term recurrence rate in the EST group was not significantly higher than that in the EST-EPBD group ( P > 0.05 ) .


The long-term recurrence rate for the EST group was significantly higher than that for the EST-EPBD group ( P < 0.05 ) .


The serum level of cholesterol , body mass index , gallstones , maximum stone diameter , number of stones , and mechanical lithotripsy were risk factors for the recurrence of ductal stones .


Minimal size of the duodenal papilla incision was a protective factor with regard to the recurrence of ductal stones .


Cholecystectomy , sex , and age were not associated with the recurrence of ductal stones .


Small-incision EST-EPBD has a similar overall success rate and a significantly lower rate of the recurrence of ductal stones , compared with those of EST alone .


Thus , the curative effect of EST-EPBD is better than that of EST alone .


Minimal size of the duodenal papilla incision protects against the recurrence of ductal stones .


To find out whether in varicocele embolization the copolymer cyanoacrylate glue ( NBCA-MS ) has a better patient tolerance compared to the monomer n-butyl-2-cyanoacrylate ( NBCA ) .


N = 112 insufficient spermatic veins ( left sided N = 84 , right sided N = 28 ) diagnosed in N = 83 adult males were prospectively randomized for blinded embolization with either NBCA N = 54 ( Histoacryl ) or with NBCA-MS N = 58 ( Glubran2 ) .


Before , during and up to one week after embolization , patient discomfort was assessed by a standardized pain scale .


Type , location and side of discomfort were noted .


Statistical analysis was performed with the Mann-Whitney U-test , the McNemar test and the Fisher 's exact test .


Embolization caused discomfort in N = 48/112 ( 43 % ) spermatic veins , comprising N = 26/54 ( 48 % ) in the NBCA group and N = 22/58 ( 38 % ) in the NBCA-MS group .


During the week after embolization , the overall number of discomfort reports rose to N = 62/106 ( 59 % ) , with an increase to N = 30/53 ( 57 % ) in the NBCA group and to N = 32/53 ( 60 % ) in the NBCA-MS group .


The number of immediate grade 2 to 4 pain reactions was N = 22/112 ( 20 % ) , and rose to N = 37/106 ( 35 % ) after one week .


No difference in discomfort during embolization and at 1 week after treatment was noted .


Characteristics , severity grading , and location of discomfort were similar in both NBCA groups , regardless the time point of observation .


Discomfort after glue embolization of varicocele is a common side effect , which might evolve to pain .


The assumed lower inflammatory reaction on NBCA-MS was not translated in an improved tolerance .


The aim of this prospective clinical study was to compare the mean durability and the failure rates of two types of orthodontic retainers .


Orthodontic patients ( 142 ) aged between 14 and 28 years were recruited in this study .


The polyethylene woven ribbon ( Ribbond , Seattle , WA , USA ) retainer was compared with a 0.0175-in flexible spiral wire ( Respond , Ormco , Glendora , CA , USA ) retainer .


When treatment was completed , the retainers were bonded from canine to canine in the maxillary and the mandibular arches of the participants .


In the follow-up visits , the patients were re-evaluated every 3 months over a period of 18 months .


The time taken for the retainers to remain without any fracture was appraised .


Kaplan-Meier analysis and the logrank test were employed to identify significant differences in the survival functions between the groups .


The rates of the retainers ' failure between the groups were analyzed using Chi-square test .


It was revealed that the mean survival of the flexible spiral wire retainer was 15.340.47 and 15.600.42 months in the maxillary and mandibular arches , respectively .


The mean survival of the ribbon retainer was 13.950.55 and 14.260.57 months in the maxillary and mandibular arches , respectively .


Ribbon retainers showed a failure rate of 50 % in the maxillary and 42.6 % in the mandibular arches .


Flexible spiral retainers showed a failure rate of 36.5 % in the maxillary and 37.8 % in the mandibular arches .


The differences were not statistically significant .


Regarding the evaluation period , the differences had limited clinical significance .


The mean survival time and the failure rates of the polyethylene woven ribbon retainer were comparable to the flexible spiral wire retainer during the 18 months after orthodontic treatment .


Low-glycemic index ( GI ) diets have been proven to have beneficial effects in such chronic conditions as type 2 diabetes , ischemic heart disease , and some types of cancer , but the effect of low-GI diets on weight loss , satiety , and inflammation is still controversial .


We assessed the efficacy of 2 moderate-carbohydrate diets and a low-fat diet with different GIs on weight loss and the modulation of satiety , inflammation , and other metabolic risk markers .


The GLYNDIET study is a 6-mo randomized , parallel , controlled clinical trial conducted in 122 overweight and obese adults .


Participants were randomly assigned to one of the following 3 isocaloric energy-restricted diets for 6 mo : 1 ) a moderate-carbohydrate and high-GI diet ( HGI ) , 2 ) a moderate-carbohydrate and low-GI diet ( LGI ) , and 3 ) a low-fat and high-GI diet ( LF ) .


At weeks 16 and 20 and the end of the intervention , changes in body mass index ( BMI ; in kg/m ( 2 ) ) differed significantly between intervention groups .


Reductions in BMI were greater in the LGI group than in the LF group , whereas in the HGI group , reductions in BMI did not differ significantly from those in the other 2 groups ( LGI : -2.45 0.27 ; HGI : -2.30 0.27 ; LF : -1.43 0.27 ; F = 4.616 , P = 0.012 ; pairwise comparisons : LGI compared with HGI , P = 1.000 ; LGI compared with LF , P = 0.016 ; HGI compared with LF , P = 0.061 ) .


The decrease in fasting insulin , homeostatic model assessment of insulin resistance , and homeostatic model assessment of cell function was also significantly greater in the LGI group than in the LF group ( P < 0.05 ) .


Despite this tendency for a greater improvement with a low-GI diet , the 3 intervention groups were not observed to have different effects on hunger , satiety , lipid profiles , or other inflammatory and metabolic risk markers .


A low-GI and energy-restricted diet containing moderate amounts of carbohydrates may be more effective than a high-GI and low-fat diet at reducing body weight and controlling glucose and insulin metabolism .


This trial was registered at Current Controlled Trials ( www.controlled-trials.com ) as ISRCTN54971867 .


Although repair augmented with mesh has been proved its priority in anatomical and functional recovery after anterior compartment reconstruction , the data about posterior compartment are scarce .


The aim of this study was to compare bowel functional outcome of posterior vaginal compartment repair with and without mesh in patients with pelvic organ prolapse ( POP ) .


This was a prospective , double-blind , clinical pilot study of 22 postmenopausal women with symptomatic POP ( overall POP-quantification [ POP-Q ] Stage III-IV ) who underwent total pelvic floor reconstruction .


Patients were grouped according to the use of mesh for posterior vaginal compartment repair : A mesh group and a nonmesh group .


POP-Q stage , the pelvic floor impact questionnaire short form-7 ( PFIQ-7 ) and anorectal manometry were evaluated before and 3 months after surgery .


Anatomical success was defined as POP-Q Stage II or less .


A t-test was used to compare preoperative with postoperative data in the two groups .


Totally , 17 ( 71 % ) were available for the follow-up .


POP-Q measurements improved significantly compared to baseline ( P < 0.05 ) in both groups .


No recurrence was observed .


Subjects in both groups reported improvement in pelvic floor symptoms , and there was no significant difference in the PFIQ-7 score between groups at follow-up ( P > 0.05 ) .


Compared with baseline , the nonmesh group exhibited a statistically significant decrease in anal residual pressure , a significant increase in the anorectal pressure difference during bowel movement , and a reduced rate of dyssynergia defecation pattern ( P < 0.05 ) .


Provided there is sufficient support for the anterior wall and apex of vagina with mesh , posterior compartment repair without mesh may be as effective as repair with mesh for anatomical recovery while providing better anorectal motor function .


Long-lasting insecticide-treated net ( LLIN ) window and door curtains alone or in combination with LLIN water container covers were analysed regarding effectiveness in reducing dengue vector density , and feasibility of the intervention .


A cluster randomised trial was conducted in an urban area of Colombia comparing 10 randomly selected control and 10 intervention clusters .


In control clusters , routine vector control activities were performed .


The intervention delivered first , LLIN curtains ( from July to August 2013 ) and secondly , water container covers ( from October to March 2014 ) .


Cross-sectional entomological surveys were carried out at baseline ( February 2013 to June 2013 ) , 9 weeks after the first intervention ( August to October 2013 ) , and 4-6 weeks after the second intervention ( March to April 2014 ) .


Curtains were installed in 922 households and water container covers in 303 households .


The Breteau index ( BI ) fell from 14 to 6 in the intervention group and from 8 to 5 in the control group .


The additional intervention with LLIN covers for water containers showed a significant reduction in pupae per person index ( PPI ) ( p = 0.01 ) .


In the intervention group , the PPI index showed a clear decline of 71 % compared with 25 % in the control group .


Costs were high but options for cost savings were identified .


Short term impact evaluation indicates that the intervention package can reduce dengue vector density but sustained effect will depend on multiple factors .


There is no consensus as to which bariatric procedure is preferred to reduce weight and improve health in patients with a body mass index higher than 50 .


To compare 5-year outcomes after Roux-en-Y gastric bypass ( gastric bypass ) and biliopancreatic diversion with duodenal switch ( duodenal switch ) .


Randomized clinical open-label trial at Oslo University Hospital , Oslo , Norway , and Sahlgrenska University Hospital , Gothenburg , Sweden .


Participants were recruited between March 17 , 2006 , and August 20 , 2007 , and included 60 patients aged 20 to 50 years with a body mass index of 50 to 60 .


The current study provides the 5-year follow-up analyses by intent to treat , excluding one participant accepted for inclusion who declined being operated on prior to knowing to what group he was randomized .


Laparoscopic gastric bypass and laparoscopic duodenal switch .


Body mass index and secondary outcomes including anthropometric measures , cardiometabolic risk factors , pulmonary function , vitamin status , gastrointestinal symptoms , health-related quality of life , and adverse events .


Sixty patients were randomly assigned and operated on with gastric bypass ( n = 31 ) and duodenal switch ( n = 29 ) .


Fifty-five patients ( 92 % ) completed the study .


Five years after surgery , the mean reductions in body mass index were 13.6 ( 95 % CI , 11.0-16 .1 ) and 22.1 ( 95 % CI , 19.5-24 .7 ) after gastric bypass and duodenal switch , respectively .


The mean between-group difference was 8.5 ( 95 % CI , 4.9-12 .2 ; P < .001 ) .


Remission rates of type 2 diabetes mellitus and metabolic syndrome and changes in blood pressure and lung function were similar between groups .


Reductions in total cholesterol , low-density lipoprotein cholesterol , triglycerides , and fasting glucose were significantly greater after duodenal switch compared with gastric bypass .


Serum concentrations of vitamin A and 25-hydroxyvitamin D were significantly reduced after duodenal switch compared with gastric bypass .


Duodenal switch was associated with more gastrointestinal adverse effects .


Health-related quality of life was similar between groups .


Patients with duodenal switch underwent more surgical procedures related to the initial procedure ( 13 [ 44.8 % ] vs 3 [ 9.7 % ] patients ; P = .002 ) and had significantly more hospital admissions compared with patients with gastric bypass .


In patients with a body mass index of 50 to 60 , duodenal switch resulted in greater weight loss and greater improvements in low-density lipoprotein cholesterol , triglyceride , and glucose levels 5 years after surgery compared with gastric bypass while improvements in health-related quality of life were similar .


However , duodenal switch was associated with more surgical , nutritional , and gastrointestinal adverse effects .


clinicaltrials.gov Identifier : NCT00327912 .


We present the results of a previously unpublished hemoglobin-based oxygen carrier ( HBOC ) study conducted in 1998-1999 .


In a multicenter , randomized , single-blind , comparative study of HBOC-201 versus allogeneic red blood cell ( RBC ) transfusions , no-cardiac surgery patients received HBOC-201 to a maximum of 7 units ( n = 83 ) or RBCs ( n = 77 ) .


Patients could be switched to RBCs for safety or any other reason .


The efficacy end points were elimination and/or reduction of allogeneic RBC transfusions for 28 days .


The proportion of patients in the HBOC-201 group that avoided RBC transfusion was 0.427 ( 95 % confidence interval , 0.321-0 .533 ) .


Subjects in the HBOC-201 group received on average 3.2 units of RBCs versus 4.4 units in the control arm ( P = 0.004 ) .


Seventy-nine ( 95.2 % ) subjects in the HBOC-201 group and 72 ( 93.5 % ) in the RBC group experienced adverse events ( AEs ) , judged to be associated with study treatment in 59 ( 71.1 % ) and 18 ( 23.4 % ) subjects , respectively .


Thirty-day mortality , 5 ( 6.0 % ) vs 4 ( 5.2 % ) patients ( P = 1.00 ) , incidence of serious AEs , 24 ( 28.9 % ) vs 20 ( 26.0 % ) ( P = 0.73 ) , or time to intensive care unit ( log-rank P = 0.15 ) or hospital discharge ( log-rank P = 0.53 ) were similar for the HBOC-201 and RBC groups , respectively .


Up to 7 units of HBOC-201 infused over the course of 6 days resulted in RBC transfusion avoidance in 43 % of patients .


There were no notable differences in mortality and serious AEs incidence .


The use of HBOC-201 was associated with a notable excess of nonserious AEs .


Early , safe , effective , and durable evidence-based interventions for children and adolescents with chronic migraine do not exist .


To determine the benefits of cognitive behavioral therapy ( CBT ) when combined with amitriptyline vs headache education plus amitriptyline .


A randomized clinical trial of 135 youth ( 79 % female ) aged 10 to 17 years diagnosed with chronic migraine ( 15 days with headache/month ) and a Pediatric Migraine Disability Assessment Score ( PedMIDAS ) greater than 20 points were assigned to the CBT plus amitriptyline group ( n = 64 ) or the headache education plus amitriptyline group ( n = 71 ) .


The study was conducted in the Headache Center at Cincinnati Children 's Hospital between October 2006 and September 2012 ; 129 completed 20-week follow-up and 124 completed 12-month follow-up .


Ten CBT vs 10 headache education sessions involving equivalent time and therapist attention .


Each group received 1 mg/kg/d of amitriptyline and a 20-week end point visit .


In addition , follow-up visits were conducted at 3 , 6 , 9 , and 12 months .


The primary end point was days with headache and the secondary end point was PedMIDAS ( disability score range : 0-240 points ; 0-10 for little to none , 11-30 for mild , 31-50 for moderate , > 50 for severe ) ; both end points were determined at 20 weeks .


Durability was examined over the 12-month follow-up period .


Clinical significance was measured by a 50 % or greater reduction in days with headache and a disability score in the mild to none range ( < 20 points ) .


At baseline , there were a mean ( SD ) of 21 ( 5 ) days with headache per 28 days and the mean ( SD ) PedMIDAS was 68 ( 32 ) points .


At the 20-week end point , days with headache were reduced by 11.5 for the CBT plus amitriptyline group vs 6.8 for the headache education plus amitriptyline group ( difference , 4.7 [ 95 % CI , 1.7-7 .7 ] days ; P = .002 ) .


The PedMIDAS decreased by 52.7 points for the CBT group vs 38.6 points for the headache education group ( difference , 14.1 [ 95 % CI , 3.3-24 .9 ] points ; P = .01 ) .


In the CBT group , 66 % had a 50 % or greater reduction in headache days vs 36 % in the headache education group ( odds ratio , 3.5 [ 95 % CI , 1.7-7 .2 ] ; P < .001 ) .


At 12-month follow-up , 86 % of the CBT group had a 50 % or greater reduction in headache days vs 69 % of the headache education group ; 88 % of the CBT group had a PedMIDAS of less than 20 points vs 76 % of the headache education group .


Measured treatment credibility and integrity was high for both groups .