The primary outcome measure was the induction-to-delivery interval , and a further outcome parameter was delivery within 48 hours .


The median times for induction of labour until delivery were 32.4 hours in the study group and 22.5 hours in the control group ( P = 0.004 ) .


This difference was not seen when evaluating according to parity ( nulliparous , P = 0.19 ; parous , P = 0.06 ) .


The rate of vaginal delivery within 48 hours did not differ between both groups .


The number of applications of misoprostol ( two versus three , P < 0.001 ) and the dose of misoprostol used was lower in the study group ( 100 versus 200 g , P < 0.001 ) .


In the study group , there were more Apgar scores of < 7 at 5 minutes ( 8 versus 1 , P = 0.04 ) .


The use of a double-balloon catheter on the first day , before starting oral misoprostol on the second day , did not improve the induction to delivery interval and the rate of delivery within 48 hours , in comparison with oral misoprostol alone .


Patients with advanced basal cell carcinoma have limited treatment options .


Hedgehog pathway signalling is aberrantly activated in around 95 % of tumours .


We assessed the antitumour activity of sonidegib , a Hedgehog signalling inhibitor , in patients with advanced basal cell carcinoma .


BOLT is an ongoing multicentre , randomised , double-blind , phase 2 trial .


Eligible patients had locally advanced basal cell carcinoma not amenable to curative surgery or radiation or metastatic basal cell carcinoma .


Patients were randomised via an automated system in a 1:2 ratio to receive 200 mg or 800 mg oral sonidegib daily , stratified by disease , histological subtype , and geographical region .


The primary endpoint was the proportion of patients who achieved an objective response , assessed in the primary efficacy analysis population ( patients with fully assessable locally advanced disease and all those with metastatic disease ) with data collected up to 6 months after randomisation of the last patient .


This trial is registered with ClinicalTrials.gov , number NCT01327053 .


Between July 20 , 2011 , and Jan 10 , 2013 , we enrolled 230 patients , 79 in the 200 mg sonidegib group , and 151 in the 800 mg sonidegib group .


Median follow-up was 139 months ( IQR 101-173 ) .


In the primary efficacy analysis population , 20 ( 36 % , 95 % CI 24-50 ) of 55 patients receiving 200 mg sonidegib and 39 ( 34 % , 25-43 ) of 116 receiving 800 mg sonidegib achieved an objective response .


In the 200 mg sonidegib group , 18 ( 43 % , 95 % CI 28-59 ) patients who achieved an objective response , as assessed by central review , were noted among the 42 with locally advanced basal cell carcinoma and two ( 15 % , 2-45 ) among the 13 with metastatic disease .


In the 800 mg group , 35 ( 38 % , 95 % CI 28-48 ) of 93 patients with locally advanced disease had an objective response , as assessed by central review , as did four ( 17 % , 5-39 ) of 23 with metastatic disease .


Fewer adverse events leading to dose interruptions or reductions ( 25 [ 32 % ] of 79 patients vs 90 [ 60 % ] of 150 ) or treatment discontinuation ( 17 [ 22 % ] vs 54 [ 36 % ] ) occurred in patients in the 200 mg group than in the 800 mg group .


The most common grade 3-4 adverse events were raised creatine kinase ( five [ 6 % ] in the 200 mg group vs 19 [ 13 % ] in the 800 mg group ) and lipase concentration ( four [ 5 % ] vs eight [ 5 % ] ) .


Serious adverse events occurred in 11 ( 14 % ) of 79 patients in the 200 mg group and 45 ( 30 % ) of 150 patients in the 800 mg group .


The benefit-to-risk profile of 200 mg sonidegib might offer a new treatment option for patients with advanced basal cell carcinoma , a population that is difficult to treat .


Novartis Pharmaceuticals Corporation .


The recent convergence between technology and medicine is offering innovative methods and tools for behavioral health care .


Among these , an emerging approach is the use of virtual reality ( VR ) within exposure-based protocols for anxiety disorders , and in particular posttraumatic stress disorder .


However , no systematically tested VR protocols are available for the management of psychological stress .


Our goal was to evaluate the efficacy of a new technological paradigm , Interreality , for the management and prevention of psychological stress .


The main feature of Interreality is a twofold link between the virtual and the real world achieved through experiential virtual scenarios ( fully controlled by the therapist , used to learn coping skills and improve self-efficacy ) with real-time monitoring and support ( identifying critical situations and assessing clinical change ) using advanced technologies ( virtual worlds , wearable biosensors , and smartphones ) .


The study was designed as a block randomized controlled trial involving 121 participants recruited from two different worker populations-teachers and nurses-that are highly exposed to psychological stress .


Participants were a sample of teachers recruited in Milan ( Block 1 : n = 61 ) and a sample of nurses recruited in Messina , Italy ( Block 2 : n = 60 ) .


Participants within each block were randomly assigned to the ( 1 ) Experimental Group ( EG ) : n = 40 ; B1 = 20 , B2 = 20 , which received a 5-week treatment based on the Interreality paradigm ; ( 2 ) Control Group ( CG ) : n = 42 ; B1 = 22 , B2 = 20 , which received a 5-week traditional stress management training based on cognitive behavioral therapy ( CBT ) ; and ( 3 ) the Wait-List group ( WL ) : n = 39 , B1 = 19 , B2 = 20 , which was reassessed and compared with the two other groups 5 weeks after the initial evaluation .


Although both treatments were able to significantly reduce perceived stress better than WL , only EG participants reported a significant reduction ( EG = 12 % vs. CG = 0.5 % ) in chronic `` trait '' anxiety .


A similar pattern was found for coping skills : both treatments were able to significantly increase most coping skills , but only EG participants reported a significant increase ( EG = 14 % vs CG = 0.3 % ) in the Emotional Support skill .


Our findings provide initial evidence that the Interreality protocol yields better outcomes than the traditionally accepted gold standard for psychological stress treatment : CBT .


Consequently , these findings constitute a sound foundation and rationale for the importance of continuing future research in technology-enhanced protocols for psychological stress management .


ClinicalTrials.gov : NCT01683617 ; http://clinicaltrials.gov/show/NCT01683617 ( Archived by WebCite at http://www.webcitation.org/6QnziHv3h ) .


Patient assessments of disease activity ( PtGA ) and general health ( GH ) measured by visual analog scale ( VAS ) are widely used in rheumatoid arthritis ( RA ) clinical practice and research .


These require comprehension of the question 's wording and translation of disease activity onto a written VAS , which is problematic for patients with limited health literacy ( HL ) or difficulty completing forms .


This study 's objective was to validate verbally administered versions of patient assessments and identify factors that might explain discrepancies between verbal and written measures .


We enrolled patients with RA at the Denver Health rheumatology clinic ( n = 300 ) .


Subjects were randomized to complete the traditional written PtGA and GH and one of the verbal assessments .


Subjects provided a verbal numeric response after reading the question , having the question read to them in person , or hearing the question over the phone .


Spearman and Lin correlations comparing written and verbal assessments were determined .


Multivariate logistic regression was performed to explain any discrepancies .


The instruments administered verbally in-person showed good , but not excellent , correlation with traditional written VAS forms ( Spearman coefficients 0.59 to 0.70 ; p < 0.001 for all correlations ) .


Twenty-three percent of subjects were unable to complete 1 of the written VAS assessments without assistance .


HL predicted missing written data and discrepancies between verbal and written assessments ( p < 0.05 for all correlations ) .


Providers should use verbal versions of PtGA and GH with caution while caring for patients unable to complete traditional written version .


Limited HL is widely prevalent and a barrier to obtaining patient-oriented data .


Concomitant type 2 diabetes ( T2D ) and metabolic syndrome exacerbates mortality risk ; yet , few studies have examined the effect of combining ( AER + RES ) aerobic ( AER ) and resistance ( RES ) training for individuals with T2D and metabolic syndrome .


We examined AER , RES , and AER + RES training ( 9 months ) commensurate with physical activity guidelines in individuals with T2D ( n = 262 ; 63 % female , 44 % black ) .


Primary outcomes were change in , and prevalence of , metabolic syndrome score at follow-up ( mean and 95 % confidence interval [ CI ] ) .


Secondary outcomes included maximal cardiorespiratory fitness ( VO2peak ) and estimated METs from time-to-exhaustion ( TTE ) and exercise efficiency calculated as the slope of the line between ventilatory threshold , respiratory compensation , and maximal fitness .


General linear models and bootstrapped Spearman correlations were used to examine changes in metabolic syndrome associated with training primary and secondary outcome variables .


We observed a significant decrease in metabolic syndrome scores ( P for trend = 0.003 ) for AER ( -0.59 , 95 % CI = -1.00 to -0.21 ) and AER + RES ( -0.79 , 95 % CI = -1.40 to -0.35 ) , both being significant ( P 0.02 ) versus control ( 0.26 , 95 % CI = -0.58 to 0.40 ) and RES ( -0.13 , 95 % CI = -1.00 to 0.24 ) .


This led to a reduction in metabolic syndrome prevalence for the AER ( 56 % vs 43 % ) and AER + RES ( 55 % vs 46 % ) groups between baseline and follow-up .


The observed decrease in metabolic syndrome was mediated by significant improvements in exercise efficiency for the AER and AER + RES training groups ( P < 0.05 ) , which was more strongly related to TTE ( 25 % -30 % ; r = -0.38 , 95 % CI = -0.55 to -0.19 ) than VO2peak ( 5 % -6 % ; r = -0.24 , 95 % CI = -0.45 to -0.01 ) .


AER and AER + RES training significantly improved metabolic syndrome scores and prevalence in patients with T2D .


These improvements appear to be associated with improved exercise efficiency and are more strongly related to improved TTE versus VO2peak .


The pathophysiology of erectile dysfunction ( ED ) may be vasculogenic , hormonal , anatomical , neurogenic , drug-induced and/or psychogenic in origin .


Neuropathic pain ( NP ) may facilitate ED , because it is frequently associated with anxiety , depression , and its drug , pregabalin , may also contribute ED .


The objective of this study was to determine whether pregabalin treatment for patients with neuropathic pain promotes erectile dysfunction .


The study sample consisted of a total of 102 male subjects that were subdivided into three groups .


Group 1 patients ( n = 31 ) had a pre-existing diagnosis of NP and was treated with 300mg/day of pregabalin for at least 3 months .


Group 2 patients ( n = 34 ) were diagnosed with NP for at least 3 months ; however , neither were they treated with pregabalin nor did they received physical therapy throughout the study .


Lastly , healthy age-matched control subjects comprised group 3 ( n = 37 ) .


Patients in all groups completed the International Index for Erectile Function ( IIEF ) questionnaire .


Mean age and mean body mass index did not differ significantly between each of the three groups .


The cause of NP and the mean duration of having a diagnosis of NP did not differ significantly in groups 1 and 2 .


However , IIEF scores were significantly lower for group 1 when compared to group 2 in terms of erectile function , orgasmic function , overall satisfaction and total score .


Yet groups 1 and 2 did not diverge significantly in the intercourse satisfaction and sexual desire scores .


Overall IIEF scores for group 3 were significantly higher than those of group 2 except for mean erectile function scores .


Taking pregabalin for the treatment of neuropathic pain poses an increased risk for developing ED in male patients .


Thus , clinicians prescribing pregabalin to patients diagnosed with neuropathic pain should assess for ED before and during treatment with this medication .


To study the effect of Zhibai Dihuang Pill ( ZBDHP ) on urokinase-type plasminogen activator ( uPA ) and sperm quality in ureaplasma urealyticum ( Uu ) infection infertile patients .


Recruited were 80 infertility patients with Uu infection at Andriatrics Clinics and Department of Reproduction , including 130 cases of positive Uu semen and 50 cases of negative Uu semen .


Patients with positive Uu semen were randomly assigned to the observation group ( 72 cases ) and the control group ( 58 cases ) according to the visit sequence .


All patients took antibiotics for 2 weeks .


Patients in the observation group additionally took ZBDHP , 6 g each time , twice daily .


Those in the control group additionally took Vit E ( 100 mg each time , twice per day ) and ATP ( 40 mg each time , twice per day ) .


The therapeutic course for all was 90 days .


Semen parameters and uPA contents of the sperm membrane were detected and comparatively analyzed .


The sperm membrane uPA content , the sperm motility , the sperm viability , and the percentage of normal morphology sperm in Uu positive infected patients were lower than those in Uu negative infected patients with statistical difference ( P < 0.05 ) , but with no significant difference in the sperm density between the two groups ( P > 0.05 ) .


There was no statistical difference in pre-treatment sperm membrane uPA contents and sperm parameters between the two groups ( P > 0.05 ) .


Compared with before treatment in the same group , the sperm membrane uPA content , the sperm motility , the sperm viability , and the percentage of normal morphology sperm obviously increased in the two groups with statistical difference ( P < 0.05 ) .


After treatment , the sperm membrane uPA content increased more obviously in the observation group , with statistical difference when compared with the control group ( P < 0.05 ) .


Infection with Uu leads to decreased uPA content of sperm membrance and the sperm motility .


ZBDHP could effectively treat Uu infected infertility possibly through fighting against Uu damaged sperm membrane and make the sperm membrane uPA content return to normal , and elevate the fertilizability of sperms .


To observe the impacts on the muscle strength in the patients of stroke-induced acroparalysis treated with Xunjingcuiqi needling technique .


One hundred patients were randomized into a Xunjingcuiqi group and a routine acupuncture group , 50 cases in each group .


In the routine acupuncture group , the routine acupuncture technique was adopted at the main acupoints , such as Shangxing ( GV 23 ) , Baihui ( GV 20 ) , Dicang ( ST 4 ) , Quchi ( LI 11 ) , Huantiao ( GB 30 ) and Zusanli ( ST 36 ) , etc. .


In Xunjingcuiqi group , on the basis of the routine acupuncture technique , Xunjingcuiqi needling technique ( pricking technique was quickly applied with the filiform needle along the running course of meridian to promote the conduction of meridian qi ) was added .


For the patients being hard to feel the needling sensation and with the muscle strength of 0 to 1 degree , Dongzhencuiqi technique was supplemented at shu-stream points of yang meridians ( after qi arrival , the needling manipulation with limb movement was given to promote the conduction of meridian qi ) .


The treatment was given once every day in the two groups .


Ten treatments made one session .


Three sessions of treatment were required .


At the end of each session treatment , the muscle strength and clinical efficacy were assessed .


In the 1st , 2nd and 3rd sessions of treatment , 20 , 24 and 36 cases achieved the 3 to 5 degrees muscle strength in Xunjingcuiqi group , respectively ; and 6 , 10 and 15 cases achieved the 3 to 5 degrees muscle strength in the routine acupuncture group .


The differences were significant statistically in comparison of the two groups ( P < 0.01 , P < 0.05 ) .


The markably effective rates were 60.0 % ( 30/50 ) , 64.0 % ( 32/50 ) and 70.0 % ( 35/50 ) after the 1st , 2nd and 3rd sessions of treatment in Xunjingcuiqi group , respectively ; and those were 38.0 % ( 19/50 ) , 44.0 % ( 22/50 ) and 46.0 % ( 23/50 ) in the routine acupuncture group , respectively .


The differences were significant in the 1st and 3rd sessions of treatment between the two groups ( both P < 0.05 ) .


Xunjingcuiqi needling technique combined with routine acupuncture achieves the apparent superior efficacy on acroparalysis induced by ischemic stroke as compared with the simple routine acupuncture .


Xunjingcuiqi needling technique obviously improves muscle strength and shortens the duration of sickness .


To assess the level of evidence-based drug prescribing for acute coronary syndrome ( ACS ) at discharge from Western Australian ( WA ) hospitals and determine predictors of such prescribing in Aboriginal and non-Aboriginal patients .


All Aboriginal ( 2002-2004 ) and a random sample of non-Aboriginal ( 2003 ) hospital admissions with a principal diagnosis of ACS were extracted from the WA Hospital Morbidity Data Collection of WA Data Linkage System .


Clinical information , history of co-morbidities and drugs were collected from medical notes by trained data collectors .


Evidence-based prescribing ( EBP ) was defined as prescribing of aspirin , statin and beta-blocker or angiotensin-converting enzyme inhibitor/angiotensin II antagonist .


Records for 1717 ACS patients discharged alive from hospitals were reviewed .


The majority of patients ( 71 % ) had EBP , and there was no significant difference between Aboriginal and non-Aboriginal patients ( 70 % vs 71 % , P = 0.36 ) .


Conversely , a significantly higher proportion of Aboriginal patients had none of the drugs prescribed compared with non-Aboriginal patients ( 11 % vs 7 % , P < 0.01 ) .


EBP for ACS was independently associated with male sex ( odds ratio ( OR ) 1.63 , 95 % confidence interval ( CI ) 1.26-2 .11 ) , previous admission for ACS ( OR 1.83 , 95 % CI 1.39-2 .42 ) and diabetes ( OR 1.36 , 95 % CI 1.04-1 .79 ) .


However , ACS patients living in regional and remote areas , attending district or private hospitals , or with a history of chronic obstructive pulmonary disease were significantly less likely to have ACS drugs prescribed at discharge .


Opportunity exists to improve prescribing of recommended drugs for ACS patients at discharge from WA hospitals in both Aboriginal and non-Aboriginal patients .


Attention regarding pharmaceutical management post-ACS is particularly required for patients from rural and remote areas , and those attending district and private hospitals .


Wound cleansing should create an optimal healing environment by removing excess debris , exudates , foreign and necrotic material which are commonly present in the wounds that heal by secondary intention .


At present , there is no research evidence for whether pressurised irrigation has better wound healing outcomes compared with conventional swabbing practice in cleansing wound .


This study investigated the differences between pressurised irrigation and swabbing method in cleansing wounds that healed by secondary intention in relation to wound healing outcomes and cost-effectiveness .


Multicentre , prospective , randomised controlled trial .


The study took place in four General Outpatient Clinics in Hong Kong .


Two hundred and fifty six patients with wounds healing by secondary intention were randomly assigned by having a staff independent of the study opening a serially numbered , opaque and sealed envelope to either pressurised irrigation ( n = 122 ) or swabbing ( n = 134 ) .


Staff undertaking study-related assessments was blinded to treatment assignment .


Patients ' wounds were followed up for 6 weeks or earlier if wounds had healed to determine wound healing , infection , symptoms , satisfaction , and cost effectiveness .


The primary outcome was time-to-wound healing .


Patients were analysed according to their treatment allocation .


This trial is registered with ClinicalTrials.gov , number NCT01885273 .


Intention-to-treat analysis showed that pressurised irrigation group was associated with a shorter median time-to-wound healing than swabbing group [ 9.0 days ( 95 % CI : 7.4-13 .8 ) vs. 12.0 ( 95 % CI : 10.2-13 .8 ) ; p = 0.007 ] .


Pressurised irrigation group has significantly more patients experiencing lower grade of pain during wound cleansing ( 93.4 % vs. 84.2 % ; p = 0.02 ) , and significantly higher median satisfaction with either comfort or cleansing method ( MD 1 [ 95 % CI : 5-6 ] ; p = 0.002 ; MD 1 [ 95 % CI : 5-6 ] ; p < 0.001 ) than did swabbing group .


Wound infection was reported in 4 ( 3.3 % ) patients in pressurised irrigation group and in 7 ( 5.2 % ) patients in swabbing group ( p = 0.44 ) .


Cost-effectiveness analysis indicated that pressurised irrigation in comparison with swabbing saved per patient HK$ 110 ( 95 % CI : -33 to 308 ) and was a cost-effective cleansing method at no extra direct medical cost with a probability of 90 % .


This is the first randomised controlled trial to compare the pressurised irrigation and swabbing .


Pressurised irrigation is more cost-effective than swabbing in shortening time that wound heals by secondary intention with better patient tolerance .


Use of pressurised irrigation for wound cleansing is supported by this trial .


Some investigators found a greater incidence of hypotension in patients receiving intrathecal hyperbaric solution than in patients receiving plain solution for cesarean section .


Compare the effects of intrathecal hyperbaric bupivacaine 10 mg with intrathecal bupivacaine 11 mg and intrathecal levobupivacaine 11 mg , all with 10 microg of fentanyl , for cesarean section .


This prospective , randomized , double-blinded study was approved by the Ethics Committee .


Ninety ASA I-II parturients undergoing elective cesarean section were enrolled .


Group H received 10 mg of 0.5 % hyperbaric bupivacaine plus fentanyl 10 g , Group B received 11 mg of 0.5 % bupivacaine plus fentanyl 10 g , and Group L received 11 mg of 0.5 % levobupivacaine plus fentanyl 10 g. Spinal anesthesia ( SA ) was undertaken in right lateral position and spinal solutions were injected approximately 30 to 40 seconds .


Sensory and motor block were assessed at 5-minute intervals .


Side-effects such as hypotension , nausea , pruritus , shivering , and headache were recorded


Demographic data were similar in all groups .


The level of an absence of cold sensation , the level of pinprick analgesia , and time to achieve sensory block to T4 level of Group H was significantly higher than Group B and Group L.


The degree of motor block was comparable in all groups .


The incidence of visceral pain was minimal , rated as mild pain and only found in Group B.


The incidence of hypotension was comparable with Group H = 67 % , Group B = 56 % , and Group L = 50 % .


Other side effects such as nausea , vomiting , pruritus , shivering , and headache were not statistically significant .


Patient 's satisfaction rated as very good and was not different between the three groups .


The level of absence of cold sensation , level of pinprick analgesia , and time to achieve sensory block to T4 level were statistically higher in patients receiving hyperbaric bupivacaine than in patients receiving plain bupivacaine and plain levobupivacaine , while the differences were not statistically significant in all groups regarding effective surgical anesthesia , postoperative analgesia , and side effects .


Therefore , Levobupivacaine can be an alternative to bupivacaine .


To investigate the effects of whole body vibration ( WBV ) training on gait function in persons with mild multiple sclerosis ( MS ) .


A randomized controlled trial .


18 patients with MS were assigned randomly to WBV ( intervention group ) or to placebo WBV .


Both groups performed a 3-week training period under static conditions on a vibration platform .


In the placebo group , the vibration platform was covered and therefore vibrations could not operate .


Gait function ( gait velocity , stride length , double support phase , single-step variability left and right ) was assessed at baseline , after 3-weeks of WBV intervention or sham WBV , 4-weeks after baseline , and 5-weeks after baseline using a mobile plantar food pressure system and the `` Timed Up and Go '' test under four different gait conditions ( comfortable overground gait , comfortable gait on treadmill , -20 % comfortable gait velocity on treadmill and +20 % comfortable gait velocity on treadmill ) .


None of the outcome measures of gait function showed statistically significant alterations following 3-weeks of intervention/placebo WBV .


The applied protocol of WBV does not show a meaningful improvement of gait function in mildly affected MS patients .


Computer-assisted surgery ( CAS ) may facilitate better positioning of total knee arthroplasty ( TKA ) along the coronal and lateral axes ; however , there are doubts as to its usefulness in the rotational plane .


This is a prospective study of 95 TKAs comparing two groups : the CAS group and the standard equipment group .


The series comprises 95 cases .


A radiography of the lower limb and computer tomographies ( CTs ) of the femoral condylar region , the proximal end of the tibia and the ankle were performed to measure rotational angulation .


A month after TKA surgery , the radiography and the CTs were repeated to analyze the position of the prosthetic components in the rotational plane .


In the coronal axis , both CAS and mechanical technique improved femoro-tibial alignment , but when there are preexisting deformities 4 , CAS obtains better results .


A strong correlation ( R = 0.94 , p = 0.001 ) was observed between the mean rotational axis measured with CT in the tibial plateau and that measured from the axis of the ankle .


The mean initial femoral rotation of the complete series was 6.7 and 2.7 at 1-month follow-up ( p < 0.001 ) .


In the standard instrumentation group , the femoral rotation went from 6.8 to 2.3 , whereas in the CAS group the femoral rotation went from 6.5 to 3.1 ( p = 0.039 ) , which is very close to the ideal 3 angle of external rotation .


Tibial rotation changed by 5.28 for the entire patient population , but no differences were found when comparing CAS and standard instrumentation .


CAS improves frontal alignment in TKA , especially in the presence of preoperative deformities .


In the femoral component , navigation most closely replicated the ideal 3 external rotation of the femoral component , but tibial rotation did not differ when comparing CAS to standard instrumentation .


II .


Although minocycline is not licensed for use in dogs , this tetracycline has therapeutic potential against meticillin-resistant Staphylococcus pseudintermedius .


The aim of this study was to establish rational dosage recommendations for minocycline use in dogs .


Specific objectives were to generate and analyse minocycline pharmacokinetic ( PK ) data on plasma and interstitial fluid ( ISF ) concentrations , plasma protein binding and pharmacodynamic ( PD ) data on antimicrobial activity against S.pseudintermedius .


Six healthy dogs from a research colony were used in this study .


Dogs were administered 5mg/kg intravenously and 10mg/kg orally ( p.o. ) of minocycline hydrochloride in separate crossover experiments .


In vivo drug concentrations in plasma and in ISF collected by ultrafiltration were measured by high-performance liquid chromatography .


Pharmacokinetic analysis was performed on plasma and ISF concentrations .


PK/PD analysis was completed using in vitro data on plasma protein binding and minocycline susceptibility in 168 S.pseudintermedius isolates .


Minocycline distributed to the ISF to a higher degree than predicted by the protein-unbound fraction in plasma .


A large volume of distribution after oral administration , with plasma and ISF elimination half-lives of 4.1 and 7.4 h , respectively , demonstrated that the ISF serves as a drug reservoir for sustained tissue concentrations .


Monte Carlo simulation , used to assess target attainment at different drug dosages , indicated that p.o. administration of 5mg/kg twice daily is sufficient to inhibit S.pseudintermedius strains with minimal inhibitory concentrations 0.25 g/mL .


Besides dosage recommendations for therapy of meticillin-resistant Staphylococcus pseudintermedius infections in dogs , the study also provides PK/PD data necessary to consider species-specific clinical breakpoints for minocycline susceptibility testing .


Turning gait is an integral part of daily ambulation and likely poses a greater challenge for patients with transtibial amputation compared with walking a straight pathway .


A torsion adapter is a prosthetic component that can increase transverse plane compliance of the prosthesis and decrease the torque applied to the residual limb , but whether this will improve patients ' mobility , pain , and fatigue remains unknown .


Does prescription of a torsion adapter translate to improvements in ( 1 ) functional mobility and ( 2 ) self-perceived pain and fatigue in moderately active patients with lower limb amputation ?


Ten unilateral transtibial amputees wore a torsion or rigid adapter in random order .


Functional mobility was assessed through a field measurement using an activity monitor and through a laboratory measurement using a 6-minute walk test that included turns .


The residual limb pain grade assessed self-perceived pain and the Multidimensional Fatigue Inventory assessed fatigue .


We found relatively small functional differences for amputees wearing a torsion adapter versus a rigid adapter .


Amputees wearing a torsion adapter tended to take more low - and medium-intensity steps per day ( 331 365 and 437 511 difference in steps ; effect size = 0.44 and 0.17 ; confidence interval [ CI ] , 70-592 and 71-802 ; p = 0.019 and 0.024 , respectively ) .


They also experienced less pain interference with activities ( 1.9 1.7 change in score ; effect size = 0.83 ; CI , 0.3-3 .4 ; p = 0.026 ) when wearing a torsion adapter .


However , these patients took a similar number of total steps per day , walked a comparable distance in 6 minutes , and reported similar residual limb pain and fatigue .


For a moderately active group of amputees , the torsion adapter did not translate to substantial improvements in functional mobility and self-perceived pain and fatigue .


The small increases in low - and medium-intensity activities with less pain interference when wearing a torsion adapter provides evidence to support prescribing this device for amputees with difficulty navigating the household and community environments .


This study was designed to investigate the effect of a single-drop instillation of different lacrimal substitutes on tear film thickness ( TFT ) assessed with optical coherence tomography in patients with mild to moderate dry eye disease .


The study was performed in a randomized , double-masked , controlled parallel group design .


Patients received a single dose of either unpreserved trehalose 30 mg/mL and sodium hyaluronate 1.5 mg/mL ( TH-SH , Thealoz Duo ) , unpreserved sodium hyaluronate , 0.15 % ( HA , Hyabak ) or sodium chloride , 0.9 % ( NaCl , Hydrabak ) eye drops .


Sixty patients finished the study according to the protocol .


TFT was measured with a custom-built ultrahigh-resolution Fourier domain optical coherence tomography system providing a resolution of 1.2 m.


The mean TFT before treatment was 2.5 0.4 m. Ten minutes after instillation , TFT significantly increased in the TH-SH group from 2.4 0.4 to 3.1 0.9 m ( P < 0.01 ) and in the HA group from 2.4 0.3 to 2.9 0.5 m ( P < 0.01 ) , whereas no significant change was observed in the NaCl group ( from 2.6 0.4 to 2.7 0.4 m , P = 0.76 ) .


The increase in TFT remained statistically significant up to 240 minutes after administration of TH-SH .


In contrast , the increase in TFT after administration of HA was only statistically significant at 10 , 20 , and 40 minutes after drop instillation .


The findings of this study indicate that single instillation of TH-SH and HA eye drops increases TFT in patients with dry eye disease .


The data also indicate longer corneal residence of the TH-containing eye drops .


The effect of multiple instillation and long-term use of artificial tears on TFT warrants further investigation .


To evaluate the effect of intense pulsed light ( IPL ) applied to the periocular area for meibomian gland dysfunction ( MGD ) in a prospective , double-masked , placebo-controlled , paired-eye study .


Twenty-eight participants underwent IPL treatment , with homogeneously sequenced light pulses delivered to one eye and placebo treatment to the partner control eye at 1 , 15 , and 45 days following baseline ( BL ) evaluation .


Lipid layer grade ( LLG ) , noninvasive tear break-up time ( NIBUT ) , tear evaporation rate ( TER ) , tear meniscus height ( TMH ) , and subjective symptom score using visual analogue scales ( VAS ) were compared with BL and control values at each visit .


Lipid layer grade improved significantly from BL to Day ( D ) 45 in the treated eye ( P < 0.001 ) , but not the control eye ( P = 0.714 ) , with 82 % of treated eyes improving by at least one LLG .


Noninvasive tear break-up time also improved significantly from BL to D45 in the treated ( P < 0.001 ) but not in the control eye ( P = 0.056 ) and was significantly longer than in the treated eye at D45 ( 14.1 9.8 seconds versus 8.6 8.2 seconds , P < 0.001 ) .


The tear evaporation rate was not different in the treated eye compared with the control eye at any visit .


Tear meniscus height did not change from BL in either eye ( P > 0.05 ) .


Visual analog scale symptom scores improved from BL in the treated ( P = 0.015 ) , but not the control eye ( P = 0.245 ) , with 86 % of participants noting reduced symptoms in the treated eye by D45 .


Intense pulsed light with multiple sculpted pulses shows therapeutic potential for MGD , improving tear film quality and reducing symptoms of dry eye .


( https://www.anzctr.org.au number , ACTRN12614000162617 . )


To compare the efficacy of topical 1 % voriconazole vs 5 % natamycin for the treatment of fungal keratitis .


In a prospective , double-masked , randomised , controlled , registered clinical trial , 118 patients with fungal keratitis were treated using identical dosage schedule with either voriconazole ( 58 ) or natamycin ( 60 ) as inpatients for 7days and followed up weekly .


The outcome measures were percentage of patients with healed or resolving ulcer and final visual acuity at last follow-up ( primary ) and on day 7 ( secondary ) in each group .


More patients ( p = 0.005 ) on natamycin ( 50/56 , 89.2 % ) had healed or resolving ulcer compared with voriconazole ( 34/51 , 66.6 % ) at last follow-up .


The improvement in vision was marginally greater in patients in the natamycin group compared with the voriconazole group at day 7 ( p = 0.04 ) and significantly greater at final visit ( p = 0.01 ) .


In univariate analysis , drug , age and mean size of corneal infiltrate and epithelial defect had a significant effect on the final visual outcome .


In multivariate analysis , the effect of drug ( voriconazole vs natamycin , adjusted coefficient 0.27 ( -0.04 to 0.57 ) , p = 0.09 ) was marginal while the effect of age and epithelial defect was significant ( p < 0.001 for both ) .


In the group treated with natamycin , the final visual acuity was significantly better ( p = 0.005 , Wilcoxon signed-rank test ) in patients with Fusarium keratitis but not with Aspergillus keratitis ( p = 0.714 , paired t test ) .


When compared with voriconazole , natamycin was more effective in the treatment of fungal keratitis , especially Fusarium keratitis .


Clinical Trial Registry India ( 2010/091/003041 ) .


The Radiation Therapy Oncology Group 9804 study identified good-risk patients with ductal carcinoma in situ ( DCIS ) , a breast cancer diagnosis found frequently in mammographically detected cancers , to test the benefit of radiotherapy ( RT ) after breast-conserving surgery compared with observation .


This prospective randomized trial ( 1998 to 2006 ) in women with mammographically detected low - or intermediate-grade DCIS , measuring less than 2.5 cm with margins 3 mm , compared RT with observation after surgery .


The study was designed for 1,790 patients but was closed early because of lower than projected accrual .


Six hundred thirty-six patients from the United States and Canada were entered ; tamoxifen use ( 62 % ) was optional .


Ipsilateral local failure ( LF ) was the primary end point ; LF and contralateral failure were estimated using cumulative incidence , and overall and disease-free survival were estimated using the Kaplan-Meier method .


Median follow-up time was 7.17 years ( range , 0.01 to 11.33 years ) .


Two LFs occurred in the RT arm , and 19 occurred in the observation arm .


At 7 years , the LF rate was 0.9 % ( 95 % CI , 0.0 % to 2.2 % ) in the RT arm versus 6.7 % ( 95 % CI , 3.2 % to 9.6 % ) in the observation arm ( hazard ratio , 0.11 ; 95 % CI , 0.03 to 0.47 ; P < .001 ) .


Grade 1 to 2 acute toxicities occurred in 30 % and 76 % of patients in the observation and RT arms , respectively ; grade 3 or 4 toxicities occurred in 4.0 % and 4.2 % of patients , respectively .


Late RT toxicity was grade 1 in 30 % , grade 2 in 4.6 % , and grade 3 in 0.7 % of patients .


In this good-risk subset of patients with DCIS , with a median follow-up of 7 years , the LF rate was low with observation but was decreased significantly with the addition of RT. .


Longer follow-up is planned because the timeline for LF in this setting seems protracted .


To evaluate the effects of 2 low-calorie diets but with different distributions of calories throughout the day on weight loss and other major obesity-related metabolic parameters .


We randomly assigned 42 nonsmoking homemakers ( age = 46.3 2.3 years , body mass index [ BMI ] = 35.7 0.8 kg/m ( 2 ) , mean SD ) in 2 groups of 21 subjects ( G1 and G2 ) .


The participants underwent a 3 month individualized Mediterranean-style diet ( 55 % carbohydrate , 30 % fat , 15 % protein and fiber > 30 g ) , calorie ( 600 kcal daily deficit compared to the total energy expenditure measured by a metabolic Holter ) .


Diets consisted of the same food and complied with cardiovascular disease prevention guidelines but differed in the distribution of calories throughout the day ( G1 : 70 % breakfast , morning snack , lunch and 30 % afternoon snack and dinner ; G2 : 55 breakfast , morning snack , lunch and 45 % afternoon snack and dinner ) .


Dual-energy X-ray absorptiometry was used for pre - and postintervention body composition assessment .


Thirty-six subjects completed the study ( G1 = 18 , G2 = 18 ) .


Both groups had significant improvements in body composition and metabolic parameters but G1 had enhanced results for weight loss ( G1 : -8.2 3.0 kg ; G2 : -6.5 3.4 kg ; p = 0.028 ) , waist circumference reduction ( G1 : -7 0.6 cm ; G2 : -5 0.3 cm ; p = 0.033 ) , and fat mass loss ( G1 : -6.8 2.1 kg , G2 : -4.5 2.9 kg , p = 0.031 ; mean SD ) .


Improvements were detected in both groups for blood pressure and blood and lipid parameters .


G1 subjects showed a greater improvement in insulin sensitivity measured by homeostasis model assessment-estimated insulin resistance ( G1 : -1.37 0.27 , G2 : -0.74 0.12 , p = 0.017 ) .


These data suggest that a low-calorie Mediterranean diet with a higher amount of calories in the first part of the day could establish a greater reduction in fat mass and improved insulin sensitivity than a typical daily diet .


Dynamic contrast-enhanced magnetic resonance imaging ( DCE-MRI ) is increasingly used for breast cancer diagnosis as supplementary to conventional imaging techniques .


Combining of diffusion-weighted imaging ( DWI ) of morphology and kinetic features from DCE-MRI to improve the discrimination power of malignant from benign breast masses is rarely reported .


The study comprised of 234 female patients with 85 benign and 149 malignant lesions .


Four distinct groups of features , coupling with pathological tests , were estimated to comprehensively characterize the pictorial properties of each lesion , which was obtained by a semi-automated segmentation method .


Classical machine learning scheme including feature subset selection and various classification schemes were employed to build prognostic model , which served as a foundation for evaluating the combined effects of the multi-sided features for predicting of the types of lesions .


Various measurements including cross validation and receiver operating characteristics were used to quantify the diagnostic performances of each feature as well as their combination .


Seven features were all found to be statistically different between the malignant and the benign groups and their combination has achieved the highest classification accuracy .


The seven features include one pathological variable of age , one morphological variable of slope , three texture features of entropy , inverse difference and information correlation , one kinetic feature of SER and one DWI feature of apparent diffusion coefficient ( ADC ) .


Together with the selected diagnostic features , various classical classification schemes were used to test their discrimination power through cross validation scheme .


The averaged measurements of sensitivity , specificity , AUC and accuracy are 0.85 , 0.89 , 90.9 % and 0.93 , respectively .


Multi-sided variables which characterize the morphological , kinetic , pathological properties and DWI measurement of ADC can dramatically improve the discriminatory power of breast lesions .


Depression is one of the most common disorders in Psychiatric and Primary Care settings and is associated with significant disability and economic costs .


Low-intensity psychological interventions applied by Information and Communication Technologies ( ICTs ) could be an efficacious and cost-effective therapeutic option for the treatment of depression .


The aim of this study is to assess 3 low-intensity psychological interventions applied by ICTs ( healthy lifestyle , positive affect and mindfulness ) in Primary Care ; significant efficacy for depression treatment has previously showed in specialized clinical settings by those interventions , but ICTs were not used .


Multicenter controlled randomized clinical trial in 4 parallel groups .


Interventions have been designed and on-line device adaptation has been carried out .


Subsequently , the randomized controlled clinical trial will be conducted .


A sample of N = 240 mild and moderate depressed patients will be recruited and assessed in Primary Care settings .


Patients will be randomly assigned to a ) healthy lifestyle psychoeducational program + improved primary care usual treatment ( ITAU ) , b ) focused program on positive affect promotion + ITAU c ) mindfulness + ITAU or d ) ITAU .


The intervention format will be one face to face session and four ICTs on-line modules .


Patients will be diagnosed with MINI psychiatric interview .


Main outcome will be PHQ-9 score .


They will be also assessed by SF-12 Health Survey , Client Service Receipt Inventory , EuroQoL-5D questionnaire , Positive and Negative Affect Scale , Five Facet Mindfulness Questionnaire and the Pemberton Happiness Index .


Patients will be assessed at baseline , post , 6 and 12 post-treatment months .


An intention to treat and per protocol analysis will be performed .


Low-intensity psychological interventions applied by Information and Communication Technologies have been not used before in Spain and could be an efficacious and cost-effective therapeutic option for depression treatment .


The strength of the study is that it is the first multicenter controlled randomized clinical trial of three low intensity and self-guided interventions applied by ICTs ( healthy lifestyle psychoeducational program ; focused program on positive affect promotion and brief intervention based on mindfulness ) in Primary Care settings .


Current Controlled Trials ISRCTN82388279 .


Registered 16 April 2014 .


In Lebanon , childhood obesity doubled during the past decade .


Preventive measures should start early in life and Schools are considered an important environment to promote energy balance health behaviours .


School-based programmes promoting healthy lifestyles are lacking .


The purpose of this study was to evaluate the feasibility and effectiveness of a multicomponent school-based intervention to promote healthy eating and physical activity ( and prevent obesity ) with school children aged 9-11 years in Lebanon .


The intervention was developed based on the constructs of the Social Cognitive Theory and adapted to the culture of Lebanese and Arab populations .


It consisted of three components : class curriculum , family involvement and food service .


Eight schools were purposively selected from two communities of different socioeconomic status ( SES ) in Beirut and , within each school type , were matched on SES , religious sect profile , and then randomly assigned to either the intervention or control group .


Anthropometric measurements and questionnaires on determinants of behavioural change , eating and physical activity habits were completed by the students in both groups at baseline and post intervention .


Focus group interviews were conducted in intervention schools at the end of the study .


Challenges encountered during the programme implementation were also identified , since Lebanon is considered a country with political unrest and no similar research projects were conducted in the area .


Students in the intervention group reported purchasing and consuming less chips and sweetened drinks post-intervention compared with controls ( 86 % & 88 % less respectively p < 0.001 ) .


Knowledge and self-efficacy scores increased for the intervention ( +2.8 & +1.7 points respectively p < 0.001 ) but not for the control group .


There was no difference in physical activity and screen time habits and no changes in BMI between groups at post intervention .


Interview data from focus groups showed that the programme was generally well accepted .


Limitations for better outcomes include the length of the programme and the school environment .


`` Health-E-PALS '' intervention is a promising innovative , theory-based , culturally sensitive intervention to promote healthy eating habits and physical activity in Lebanese school children with a potential to be scaled up , replicated and sustained .


Melasma is an acquired hyperpigmentation on sun-exposed areas .


Multiple approaches are used to treat it , but all include broad ultraviolet ( UV ) - spectrum sunscreens .


Visible light ( VL ) can induce pigmentary changes similar to those caused by UV radiation on darker-skinned patients .


To assess the efficacy of sunscreen with broad-spectrum UV protection that contains iron oxide as a VL-absorbing pigment ( UV-VL ) compared with a regular UV-only broad-spectrum sunscreen for melasma patients exposed to intense solar conditions .


Sixty-eight patients with melasma were randomized in two groups to receive either UV-VL sunscreen or UV-only sunscreen , both with sun protection factor 50 , over 8 weeks .


All patients received 4 % hydroquinone as a depigmenting treatment .


At onset and at conclusion of the study , they were assessed by the Melasma Activity and Severity Index ( MASI ; a subjective scale ) , colorimetry ( L * ) and histological analysis of melanin .


Sixty-one patients concluded the study .


At 8 weeks , the UV-VL group showed 15 % , 28 % and 4 % greater improvements than the UV-only group in MASI scores , colorimetric values and melanin assessments , respectively .


UV-VL sunscreen enhances the depigmenting efficacy of hydroquinone compared with UV-only sunscreen in treatment of melasma .


These findings suggest a role for VL in melasma pathogenesis .


Both vitamin C deficiency and inflammation are prevalent in maintenance hemodialysis ( MHD ) patients .


In this study , we aimed to elucidate the effect of oral vitamin C supplementation on inflammatory status in MHD patients with low vitamin C level and high hypersensitive C-reactive protein ( hs-CRP ) level .


A total of 128 patients were recruited in our present study .


Patients were divided into two groups .


In group 1 ( n = 67 ) , patients were orally administered with 200 mg/day vitamin C in the first 3 months , and then the vitamin C supplementation was withdrawn in the next 3 months .


In group 2 ( n = 61 ) , patients were not given vitamin C in the first 3 months , and then they were orally administered with 200 mg/day in the next 3 months .


Levels of hs-CRP , prealbumin , albumin and hemoglobin as well as the EPO resistance index ( ERI ) were determined at the baseline and every 3 months throughout the study .


Plasma vitamin C level was determined by high-performance liquid chromatography with UV detection .


Among the 128 patients , 28 of them dropped out of the study before completion .


Consequently , a total of 100 patients ( group 1 : n = 48 ; group 2 : n = 52 ) were included in the final analysis .


At the baseline , the plasma vitamin C level of all patients was less than 4 g/mL .


However , this proportion was decreased to 20 % after the vitamin C supplementation for 3 months .


Compared with patients without the vitamin C supplementation , a decreased level of hs-CRP and an increased level of prealbumin were induced by the vitamin C supplementation for 3 months in both groups .


However , levels of these biomarkers returned to their original state after the supplementation was withdrawn .


Same beneficial effects on plasma albumin , hemoglobin and ERI response to vitamin C supplementation were observed in the two groups without statistical significance .


The inflammatory status in MHD patients with plasma vitamin C deficiency and high levels of inflammatory markers could be partially improved by long-term oral administration of small doses of vitamin C.


The clinical trial number : NCT01356433 .


Pharmacodynamic analysis of intravenous recombinant urate oxidase produced by Escherichia coli was performed in healthy subjects using a pharmacokinetic/pharmacodynamic ( PK/PD ) model .


A randomized , single-blind , placebo-controlled study was performed in 40 healthy Chinese subjects ( 4 groups of 10 subjects each , placebo 4:1 ratio ) who received infusions of uricase ( single doses of 0.1 , 0.2 , and 0.3 mg/kg ; multiple doses of 0.2 mgkg ( -1 ) d ( -1 ) for 7 d ) .


PK profiles were determined through plasma uricase activity , and PD profiles were established using uric acid levels in plasma and urine .


The plasma PD parameter was estimated as changes in plasma uric acid levels as the effect in the indirect response model .


Adverse events were also monitored .


A two-compartment PK model with constant iv input and first-order output was used to describe the kinetic process of plasma uricase .


The low value ( 2.8 U/L ) of drug concentration that achieved 50 % of maximum effect ( EC50 ) indicated that low plasma uricase concentrations were sufficient to produce pharmacological effects .


A strong relationship ( r ( 2 ) = 0.9991 ) between the mean uric acid concentration in blood and the mean uric acid excretion rate in urine in the range of 11 to 30 h after single dosing was found .


Infusions of uricase were well tolerated in all subjects .


The PK/PD model predicted the effective dose to be 0.1 mg/kg in healthy subjects .


The excretion rate of uric acid in urine may be used as a new index for pharmacological effects in further clinical trials .


To study the effect of Bushen Huoxue Herbs on depression of patients with Parkinson 's disease .


Ninety-six patients were randomized into two groups with 46 patients in the treatment group and 50 patients in the control group .


Both groups took western medicine as basic treatment .


The treatment group was treated with Bushen Huoxue Herbs additionally .


The observation was carried out for 9 months .


Used Encephalofluctuograph Technology ( ET ) and Hamilton Depression Scale ( HAMD ) to measure the changes of cerebral neurotransmitters and scale scores in both groups at baseline time , 3 , 6 and 9 months later to evaluate the effects of Bushen Huoxue Herbs .


In the treatment group , 5-hydroxytryptamine ( 5-HT ) , noradrenaline ( NE ) and dopamine ( DA ) levels were increased significantly when compared with pretreatment ( P < 0.05 ) , especially of 5-HT and DA levels ( P < 0.01 ) ; Compared with the control group , 5-HT and DA levels were increased significantly ( P < 0.05 ) .


After treatment , the scores of the HAMD scale was significantly decreased ( P < 0.05 ) .


No adverse effects were found in this trial .


Bushen Huoxue Herbs can improve depression of PD patients by increasing the levels of 5-HT , NE and DA in the brain and decreasing the scores of the HAMD scale with reliable effects .


Acute acquired hypofibrinogenemia in children undergoing cardiac surgery is a major concern because it often results in perioperative bleeding and high rates of allogeneic blood transfusion .


Fibrinogen concentrate has been proposed as an alternative to cryoprecipitate ( the gold standard therapy ) , with minimal infectious and immunologic risks .


Our objective was to investigate the efficacy and safety of fibrinogen concentrate in children undergoing cardiac surgery .


In this randomized pilot study , patients were allocated to receive fibrinogen concentrate ( 60 mg/kg ) or cryoprecipitate ( 10 mL/kg ) if bleeding was associated with fibrinogen levels < 1 g/dL after cardiopulmonary bypass weaning .


The primary outcome was postoperative blood losses during the 48 hours after surgery .


A total of 63 patients were included in the study , 30 in the fibrinogen concentrate group and 33 in the cryoprecipitate group .


The median 48-hour blood loss was not significantly different between the 2 groups ( 320 mL [ interquartile range , 157-750 ] vs 410 mL [ interquartile range , 215-510 ] , respectively ; P = .672 ) .


After treatment , plasma fibrinogen concentration increased similarly following administration of both products .


There were no differences in allogeneic blood transfusion after intervention treatment .


A large trial comparing fibrinogen concentrate and cryoprecipitate in the management of children with acute acquired hypofibrinogenemia during heart surgery is feasible .


The preliminary results of our study showed that the use of fibrinogen concentrate was as efficient and safe as cryoprecipitate in the management of bleeding children undergoing cardiac surgery .


Sleep problems are common and persistent during adolescence and can have negative effects on adolescents ' mood .


To date , studies that investigate the effects of sleep extension on adolescents ' sleep and depressive symptoms are still lacking .


This study aims to investigate the effects of gradual sleep extension combined with sleep hygiene advice in adolescents with chronic sleep reduction on objectively measured sleep , self-reported sleep problems and depressive symptoms .


Fifty-five adolescents with chronic sleep reduction ( mean age : 15.44 years ; 85.5 % females ) were included in the study .


Participants were randomly assigned to either a sleep extension group ( gradual sleep extension by advancing bedtimes in the evening and receiving sleep hygiene advice ) or to a control group ( no instruction ) .


Sleep was measured with actigraphy during threeweeks , the first week was the baseline week , and the last twoweeks were the experimental weeks during which sleep was extended .


Other outcome variables were self-reported sleep problems ( daytime sleepiness , symptoms of insomnia and circadian rhythm sleep disorder ) and depressive symptoms , which were assessed before and after the experimental manipulation .


During the third week of the experiment , adolescents in the sleep extension group had earlier bedtimes , earlier sleep onsets , spent more time in bed and slept longer than adolescents in the control group .


Their chronic sleep reduction , insomnia symptoms and depressive symptoms diminished significantly .


In addition , there was a trend of improved circadian rhythm sleep disorder symptoms and sleep quality .


Gradual sleep extension combined with sleep hygiene advice seems to have beneficial effects on sleep , self-reported sleep problems and depressive symptoms of adolescents with chronic sleep reduction .


Although we can not distinguish between the effects of sleep extension and sleep hygiene advice , the results suggest that advancing bedtimes can extend sleep and improve depressive symptoms .


Bruxism is a parafunctional habit characterized by grinding and/or clenching of the teeth .


It may happen while awake ( awake bruxism ) or while sleeping ( sleep bruxism ) .


In adults , the prevalence is 20 % for the awake bruxism and 8 % for the sleep bruxism .


Peripheral , central , and psychosocial factors influence the disorder , which may predispose to pain in the masticatory muscles and neck , headache , decreased pain thresholds in the masticatory and cervical muscles , limitation mandibular range of motion , sleep disorders , stress , anxiety , depression , and overall impairment of oral health .


The aim of this study is to compare two distinct physical therapy interventions with dental treatment in pain , mandibular range of motion , sleep quality , anxiety , stress , depression , and oral health in individuals with bruxism .


Participants will be randomized into one of three groups : Group 1 ( n = 24 ) intervention will consist of massage and stretching exercises ; Group 2 ( n = 24 ) will consist of relaxation and imagination therapies ; and Group 3 ( n = 24 ) will receive dental treatment .


The evaluations will be performed at baseline , immediately after treatment , and at 2-month follow-up .


Pain intensity will be assessed using the visual analogical scale , while pain thresholds will be determined using dolorimetry .


Mandibular range of motion will be assessed using digital pachymeter .


Sleep quality will be assessed by the Pittsburgh Sleep Quality Index , anxiety by the State-Trait Anxiety Inventory , stress by the Perceived Stress Scale-10 , depression by the Beck Depression Inventory , and oral health will be assessed using the Oral Health Impact Profile -- 14 .


Significance level will be determined at the 5 % level .


This project describes the randomization method that will be used to compare two physical therapy interventions with dental treatment in the management of pain , mandibular range of motion , sleep quality , anxiety , stress , depression , and oral health in individuals with bruxism .


The study will support the practice of evidence-based physical therapy for individuals with bruxism .


Data will be published after study is completed .


ClinicalTrials.gov , NCT01778881 .


Vatreptacog alfa , a recombinant factor VIIa ( rFVIIa ) analog with three amino acid substitutions and 99 % identity to native FVIIa , was developed to improve the treatment of hemophilic patients with inhibitors .


To confirm the safety and assess the efficacy of vatreptacog alfa in treating bleeding episodes in hemophilic patients with inhibitors .


In this international , multicenter , randomized , double-blind , active-controlled , crossover , confirmatory phase III trial ( adept ( ) 2 ) in patients with hemophilia A or B and inhibitors , bleeds were randomized 3 : 2 to treatment with vatreptacog alfa ( one to three doses at 80 g kg ( -1 ) ) or rFVIIa ( one to three doses at 90 g kg ( -1 ) ) .


Treatment failures after three doses of trial product ( TP ) were managed according to the local standard of care .


In the 72 patients enrolled , 567 bleeds were treated with TP .


Both vatreptacog alfa and rFVIIa gave 93 % effective bleeding control at 12 h. Vatreptacog alfa was superior to rFVIIa in secondary efficacy outcomes , including the number of doses used to treat a bleed and sustained bleeding control 24-48 h after the first dose .


Eight patients ( 11 % ) developed antibodies against vatreptacog alfa , including four with cross-reactivity against rFVIIa and one with an in vitro neutralizing effect to vatreptacog alfa .


This large randomized controlled trial confirmed the well-established efficacy and safety profile of rFVIIa , and showed that vatreptacog alfa had similar or better efficacy than rFVIIa .


However , because of the development of anti-drug antibodies , a positive benefit-risk profile is unlikely to be achieved with vatreptacog alfa .


Prucalopride is a high-affinity 5-HT4 receptor agonist for the treatment of chronic constipation .


The aims of this study were to investigate the relationship between health-related quality of life ( HRQoL ) and symptoms of constipation , and to assess the response of HRQoL to treatment using integrated data from three phase III trials of prucalopride .


This was an integrated analysis of data from three pivotal multicenter , double-blind , randomized , placebo-controlled , parallel-group trials ( ClinicalTrials.gov Identifiers : NCT00488137 , NCT00483886 and NCT00485940 ) .


Relationships were investigated between Patient Assessment of Constipation Quality of Life ( PAC-QOL ) scores , Patient Assessment of Constipation Symptoms ( PAC-SYM ) scores , bowel movement frequency ( assessed using daily diaries ) , and treatment .


Patients treated with prucalopride 2 mg ( n = 659 ) and placebo ( n = 661 ) were included in the analysis .


An improvement in PAC-SYM scores correlated well with an improvement in PAC-QOL overall score ( r = 0.711 ) and satisfaction subscale score ( r = 0.589 ) .


After 12 weeks , PAC-QOL overall score and satisfaction subscale score significantly ( p < 0.001 ) improved by 1 point ( clinically relevant ) in 36.5 % and 44.1 % of patients treated with prucalopride , compared with 18.5 % and 22.4 % with placebo respectively .


Moreover , 39.0 % of patients with an improvement in satisfaction of 1 point achieved 3 spontaneous complete bowel movements/week , compared with 7.4 % of those with no improvement in satisfaction ( < 1 point ) .


Improvements in PAC-QOL overall score and satisfaction score were associated with improvements in symptoms of chronic constipation .


Compared with placebo , treatment with prucalopride significantly improved HRQoL .


Combined treatment with cyclosporine microemulsion preconcentrate ( CyA MEPC ) and steroids has been widely used for idiopathic membranous nephropathy ( IMN ) associated with steroid-resistant nephrotic syndrome ( SRNS ) .


Recent studies have shown that once-a-day and preprandial administration of CyA MEPC is more advantageous than the conventional twice-a-day administration in achieving the target blood CyA concentration at 2 h post dose ( C2 ) .


We designed a randomized trial to compare these administrations .


IMN patients with SRNS ( age 16-75 years ) were divided prospectively and randomly into 2 groups .


In group 1 ( n = 23 ) , 2-3 mg/kg body weight ( BW ) CyA MEPC was given orally once a day before breakfast .


In group 2 ( n = 25 ) , 1.5 mg/kg BW CyA MEPC was given twice a day before meals .


CyA + prednisolone was continued for 48 weeks .


Group 1 showed a significantly higher cumulative complete remission ( CR ) rate ( p = 0.0282 ) , but not when incomplete remission 1 ( ICR1 ; urine protein 0.3-1 .0 g/day ) was added ( p = 0.314 ) .


Because a C2 of 600 ng/mL was determined as the best cut-off point , groups 1 and 2 were further divided into subgroups A ( C2 600 ng/mL ) and B ( C2 < 600 ng/mL ) .


Groups 1A and 2A revealed significantly higher cumulative remission ( CR + ICR1 ) ( p = 0.0069 ) and CR-alone ( p = 0.0028 ) rates .


On the other hand , 3 patients with high CyA levels ( C2 > 900 ng/mL ) in Group 1A were withdrawn from the study because of complications .


CyA + prednisolone treatment is effective for IMN with associated SRNS at a C2 of 600 ng/mL .


To achieve remission , preprandial once-a-day administration of CyA at 2-3 mg/kg BW may be the most appropriate option .


However , we should adjust the dosage of CyA by therapeutic drug monitoring to avoid complications .


The optimal surgical approach for treatment of oesophagogastric junction ( OGJ ) cancer is controversial .


A randomized clinical trial ( JCOG9502 ) comparing transhiatal ( TH ) and left thoracoabdominal ( LTA ) approaches was stopped after the first interim analysis owing to limited efficacy for LTA resections .


Complete 10-year follow-up data are now available .


Patients with histologically proven adenocarcinoma of the OGJ or gastric cardia with oesophageal invasion of 3cm or less were randomized to a TH or LTA approach .


Both groups underwent total gastrectomy and splenectomy with D2 nodal dissection plus para-aortic lymphadenectomy above the left renal vein .


For LTA , a thorough mediastinal lymphadenectomy below the left inferior pulmonary vein was also mandatory .


The primary endpoint was overall survival .


A total of 167 patients ( 82 TH , 85 LTA ) were enrolled .


The 10-year overall survival rate was 37 ( 95 per cent c.i. 26 to 47 ) per cent for the TH approach and 24 ( 15 to 34 ) per cent for the LTA technique ( P = 0060 ) .


The hazard ratio for death was 142 ( 098 to 205 ) for the LTA technique .


Subgroup analysis based on the Siewert classification indicated non-significant survival advantages in favour of the TH approach .


LTA resections should be avoided in the treatment of adenocarcinoma of the OGJ or gastric cardia .


NCT00149266 ( https://www.clinicaltrials.gov ) .


Infections are the most common noncardiac complication after cardiac surgery , but their incidence across a broad range of operations , as well as the management factors that shape infection risk , remain unknown .


This study sought to prospectively examine the frequency of post-operative infections and associated mortality , and modifiable management practices predictive of infections within 65 days from cardiac surgery .


This study enrolled 5,158 patients and analyzed independently adjudicated infections using a competing risk model ( with death as the competing event ) .


Nearly 5 % of patients experienced major infections .


Baseline characteristics associated with increased infection risk included chronic lung disease ( hazard ratio [ HR ] : 1.66 ; 95 % confidence interval [ CI ] : 1.21 to 2.26 ) , heart failure ( HR : 1.47 ; 95 % CI : 1.11 to 1.95 ) , and longer surgery ( HR : 1.31 ; 95 % CI : 1.21 to 1.41 ) .


Practices associated with reduced infection risk included prophylaxis with second-generation cephalosporins ( HR : 0.70 ; 95 % CI : 0.52 to 0.94 ) , whereas post-operative antibiotic duration > 48 h ( HR : 1.92 ; 95 % CI : 1.28 to 2.88 ) , stress hyperglycemia ( HR : 1.32 ; 95 % CI : 1.01 to 1.73 ) ; intubation time of 24 to 48 h ( HR : 1.49 ; 95 % CI : 1.04 to 2.14 ) ; and ventilation > 48 h ( HR : 2.45 ; 95 % CI : 1.66 to 3.63 ) were associated with increased risk .


HRs for infection were similar with either < 24 h or < 48 h of antibiotic prophylaxis .


There was a significant but differential effect of transfusion by surgery type ( excluding left ventricular assist device procedures/transplant ) ( HR : 1.13 ; 95 % CI : 1.07 to 1.20 ) .


Major infections substantially increased mortality ( HR : 10.02 ; 95 % CI : 6.12 to 16.39 ) .


Major infections dramatically affect survival and readmissions .


Second-generation cephalosporins were strongly associated with reduced major infection risk , but optimal duration of antibiotic prophylaxis requires further study .


Given practice variations , considerable opportunities exist for improving outcomes and preventing readmissions .


( Management Practices and Risk of Infection Following Cardiac Surgery ; NCT01089712 ) .


To evaluate the outcome of resistive home exercise and its possible longterm influence on health , disability , and disease activity in patients with active polymyositis ( PM ) or dermatomyositis ( DM ) .


Nineteen patients with recent-onset PM/DM were included after introduction of high-dose prednisolone .


They were assessed by independent assessors as to perceived health , muscle performance , aerobic capacity , and serum creatine phosphokinase ( CPK ) at baseline and after 24 weeks , including repeated muscle biopsies at 24 weeks ( single-blinded randomized controlled study ) , and in an open-label followup at 52 , 78 , and 104 weeks .


Patients were randomized to 12 weeks , 5 days/week resistive home exercise with telephone support and encouragement for another 12 weeks of twice-a-week home or gym exercise ( EG , n = 10 ) or to 24 weeks , 5 days/week range of motion exercise ( CG , n = 9 ) .


Patients in the CG group without inflammatory infiltrates in muscle biopsies at 24 weeks were invited to the 12-week resistive home exercises .


At baseline , the EG had poorer perceived health , but otherwise the groups were comparable .


At 24 weeks , both groups improved in muscle performance and aerobic capacity ( p < 0.001 to < 0.05 ) with no signs of increased inflammation assessed by CPK levels or muscle biopsies .


Both groups improved in muscle performance and aerobic capacity up to 52 weeks ( p < 0.05 ) lasting to 104 weeks in the EG ( p < 0.05 ) and presented minor improvements in perceived health .


Our study supports the safety of resistive exercise in patients with active PM/DM but did not reveal any between-group differences in exercise effects .


An individually adapted physical therapist-supervised home exercise program might be recommended in early active PM/DM , with regular evaluation of muscle performance and health .


Dapagliflozin is a highly selective , orally active inhibitor of renal sodium-glucose cotransporter 2 that reduces hyperglycemia by increasing urinary glucose excretion .


The goal of this study was to evaluate dapagliflozin as monotherapy in drug-naive Asian patients with type 2 diabetes whose disease was inadequately controlled with diet and exercise .


In this Phase III , multicenter , parallel-group , double-blind study , drug-naive patients with glycosylated hemoglobin ( HbA1c ) levels 7.0 % to 10.5 % ( 53-91 mmol/mol ) were randomized ( by using an interactive voice response system ) to receive placebo ( n = 132 ) , dapagliflozin 5 mg ( n = 128 ) , or dapagliflozin 10 mg ( n = 133 ) .


The primary end point was mean change from baseline in HbA1c level at week 24 ( last-observation-carried-forward ) .


Secondary end points included changes in fasting plasma glucose , 2-hour postprandial glucose , body weight , and other glycemic parameters .


Baseline characteristics were balanced across groups .


Most patients ( 89 % ) were Chinese , median disease duration was 0.2 year , and mean HbA1c level was 8.26 % .


Most patients ( 87 % ) completed the study .


At week 24 , mean reductions in HbA1c were -0.29 % for placebo versus -1.04 % and -1.11 % for dapagliflozin 5 and 10 mg , respectively ( P < 0.0001 for both doses ) .


Changes in fasting plasma glucose were 2.5 , -25.1 , and -31.6 mg/dL ( 0.14 , -1.39 , and -1.75 mmol/L ) for placebo , dapagliflozin 5 mg , and dapagliflozin 10 mg .


Changes in 2-hour postprandial glucose were 1.1 , -46.8 , and -54.9 mg/dL ( 0.06 , -2.60 , and -3.05 mmol/L ) .


Reductions in body weight were -0.27 , -1.64 , and -2.25 kg .


Proportions of patients achieving HbA1c levels < 7.0 % ( 53 mmol/mol ) were 21.3 % , 42.6 % , and 49.8 % .


Adverse events ( AEs ) occurred in 63.6 % , 61.7 % , and 60.9 % of patients , and serious AEs occurred in 1.5 % , 3.9 % , and 3.0 % of patients .


No deaths occurred .


Hypoglycemia was uncommon ( 1.5 % , 0.8 % , and 0.8 % ) ; no hypoglycemic event led to discontinuation .


Genital infections occurred in 0.8 % , 3.1 % , and 4.5 % of patients and urinary tract infections in 3.0 % , 3.9 % , and 5.3 % of patients .


No AEs of renal infection or pyelonephritis were reported .


No changes in renal function or AEs of renal failure occurred .


Compared with placebo , dapagliflozin 5 and 10 mg demonstrated clinically and statistically significant improvements in HbA1c levels after 24 weeks of treatment .


Dose-dependent , statistically significant reductions in fasting plasma glucose , postprandial glucose , and weight were also observed for both doses compared with placebo .


AEs and serious AEs were balanced across groups , with low rates of hypoglycemia and no increase in renal events .


Genital infections and urinary tract infections were more common with dapagliflozin .


Dapagliflozin as monotherapy in these drug-naive Asian patients was well tolerated , significantly improving glycemic control with the additional benefit of weight loss .


Correcting volumetric measurements of brain structures for intracranial volume ( ICV ) is important in comparing volumes across subjects with different ICV .


The aim of this study was to investigate whether intracranial area ( ICA ) reliably predicts actual ICV in a healthy pediatric cohort and in children with convulsive status epilepticus ( CSE ) .


T1-weighted volumetric MRI was performed on 20 healthy children ( control group ) , 10 with CSE with structurally normal MRI ( CSE/MR - ) , and 12 with CSE with structurally abnormal MRI ( CSE/MR + ) .


ICA , using a mid-sagittal slice , and the actual ICV were measured .


A high Spearman correlation was found between the ICA and ICV measurements in the control ( r = 0.96 ; P < 0.0001 ) , CSE/MR - ( r = 0.93 ; P = 0.0003 ) , and CSE/MR + ( r = 0.94 ; P < 0.0001 ) groups .


On comparison of predicted and actual ICV , there was no significant difference in the CSE/MR - group ( P = 0.77 ) .


However , the comparison between predicted and actual ICV was significantly different in the CSE/MR + ( P = 0.001 ) group .


Our Bland-Altman plot showed that the ICA method consistently overestimated ICV in children in the CSE/MR + group , especially in those with small ICV or widespread structural abnormalities .


After further validation , ICA measurement may be a reliable alternative to measuring actual ICV when correcting volume measurements for ICV , even in children with localized MRI abnormalities .


Caution should be applied when the method is used in children with small ICV and those with multilobar brain pathology .


The role of zoledronic acid ( ZA ) when added to the neoadjuvant treatment of breast cancer ( BC ) in enhancing the clinical and pathological response of tumors is unclear .


The effect of ZA on the antitumor effect of neoadjuvant chemotherapy has not prospectively been studied before .


NEOZOTAC is a national , multicenter , randomized study comparing the efficacy of TAC ( docetaxel , adriamycin and cyclophosphamide i.v. ) followed by granulocyte colony-stimulating factor on day 2 with or without ZA 4 mg i.v. q 3 weeks inpatients withstage II/III , HER2-negative BC .


We present data on the pathological complete response ( pCR in breast and axilla ) , on clinical response using MRI , and toxicity .


Post hoc subgroup analyses were undertaken to address the predictive value of menopausal status .


Addition of ZA to chemotherapy did not improve pCR rates ( 13.2 % for TAC+ZA versus 13.3 % for TAC ) .


Postmenopausal women ( N = 96 ) had a numerical benefit from ZA treatment ( pCR 14.0 % for TAC+ZA versus 8.7 % for TAC , P = 0.42 ) .


Clinical objective response did not differ between treatment arms ( 72.9 % versus 73.7 % ) .


There was no difference in grade III/IV toxicity between treatment arms .


Addition of ZA to neoadjuvant chemotherapy did not improve pathological or clinical response to chemotherapy .


Further investigations are warranted in postmenopausal women with BC , since this subgroup might benefit from ZA treatment .


To evaluate the effect of an exercise training program combining low-impact dance aerobic , resistance and stretching exercise on physical fitness , hormone and lipid levels of postpartum , primiparous , lactating women .


Thirty seven primiparous , lactating women were randomly assigned at 4-6 weeks postpartum to either follow an exercise training program of 50-60 min aerobic , strengthening and stretching exercise , 3 days a week , for 12 weeks ( interventional group ; n = 20 ) or no training program at all ( control group ; n = 17 ) .


The following parameters were measured at baseline and 12 weeks later : ( 1 ) for evaluation of physical fitness : VO2max , muscular endurance , joint mobility and body fat ; ( 2 ) for evaluation of the lipidemic profile : triglyceride , total cholesterol , HDL and LDL levels , and ( 3 ) levels of hormones associated with lactation : prolactin , estradiol , cortisol , TSH , fT3 and fT4 .


After completion of the exercise training program , comparisons between the interventional and the control group showed statistically significant mean changes in VO2max ( p = 0.003 ) , muscular endurance of the upper extremities ( p < 0.001 ) , and the abdomen ( p < 0.001 ) , flexibility ( p = 0.042 ) , and body fat ( p = 0.007 ) .


There were no significant differences between the two groups in mean changes of lipid and hormone levels .


Implementation of a low-impact exercise training program appears to improve physical fitness of postpartum women , while it does not seem to affect lipid levels and lactation-associated hormone levels .


Hence , implementation of an exercise training program combining low-impact dance aerobic , resistance and stretching exercise is feasible in postpartum , primiparous , lactating women .


To investigate the effects of intensive blood pressure ( BP ) lowering according to baseline BP levels and optimal achieved BP levels in patients with acute intracerebral hemorrhage ( ICH ) .


INTERACT2 was an open , blinded endpoint , randomized controlled trial in 2,839 patients with ICH within 6 hours of onset and elevated systolic BP ( SBP ) ( 150-220 mm Hg ) who were allocated to receive intensive ( target SBP < 140 mm Hg within 1 hour , with lower limit of 130 mm Hg for treatment cessation ) or guideline-recommended ( target SBP < 180 mm Hg ) BP-lowering treatment .


Outcome was physical function across all 7 levels of the modified Rankin Scale at 90 days .


Analysis of the randomized comparisons showed that intensive BP lowering produced comparable benefits on physical function at 90 days in 5 subgroups defined by baseline SBP of < 160 , 160-169 , 170-179 , 180-189 , and 190 mm Hg ( p homogeneity = 0.790 ) .


Analyses of achieved BP showed linear increases in the risk of physical dysfunction for achieved SBP above 130 mm Hg for both hyperacute ( 1-24 hours ) and acute ( 2-7 days ) phases while modest increases were also observed for achieved SBP below 130 mm Hg .


Intensive BP lowering appears beneficial across a wide range of baseline SBP levels , and target SBP level of 130-139 mm Hg is likely to provide maximum benefit in acute ICH .


This study provides Class I evidence that the effect of intensive BP lowering on physical function is not influenced by baseline BP .


To observe the effect of Qiju Dihuang Pill ( QDP ) on changes of Chinese medical syndrome types in pregnant women of Gan-Shen yin deficiency syndrome ( GSYDS ) , and to explore the correlation between imbalanced cytokine levels and GSYDS .


This was a random controlled trail .


A total of 163 pregnant women of GSYDS at 12 -16 gestational weeks were randomly allocated into the experimental group ( 86 cases ) and the control group ( 77 cases ) .


Patients in the experimental group took QDP for 2 -4 weeks .


Changes of Chinese medical syndrome types and serum interferon-gamma ( IFN-gamma ) and interleukin-4 ( IL-4 ) levels were observed and compared between the two groups before and after treatment .


( 1 ) Totally 41 patients ( 47.7 % ) in the experimental group were transformed to normal Chinese medical syndrome type .


In the same period of the follow-ups , 9 patients ( 11.7 % ) in the control group were transformed to normal Chinese medical syndrome type , showing statistical difference ( P < 0.05 ) .


( 2 ) In the experimental group , the serum level of IFN-gamma and the ratio of IFN-gamma/IL -4 in the peripheral blood were obviously lower after treatment than before treatment ( P < 0.01 ) , and obviously lower than those in the control group ( P < 0.01 ) .


The level of IL-4 after treatment in the experimental group was higher than that before treatment , and also higher than that in the control group , but with no statistical difference .


These results indicated that there was imbalanced IFN-gamma/IL -4 ratio in the peripheral blood of pregnant women of GSYDS .


QDP might play a role in immunoregulation by affecting the IFN-gamma level .


The aim of this study was to compare the effect of two energy-restricted , differing with regard to protein content , on the inflammation state of obese individuals with features of metabolic syndrome .


Ninety-six participants completed an 8-wk randomized intervention trial that compared the RESMENA diet ( -30 % energy , with 30 % energy from protein ) with a control diet ( -30 % energy , with 15 % energy from protein ) that was based on American Heart Association criteria .


The mean body weight losses were 7.09 0.82 kg and 6.73 0.71 kg , respectively , with no differences seen between the groups .


The endpoint inflammation score-which was based on high-sensitivity C-reactive protein , interleukin-6 , tumor necrosis factor - , and plasminogen activator inhibitor-1 levels-was significantly lower ( P = 0.012 ) in the low-protein group ( 6.81 2.32 versus 7.94 1.94 ) .


The linear regression analyses revealed that total protein intake was positively associated with inflammation ( P = 0.007 ) as well as with animal protein ( P = 0.025 ) and meat protein ( P = 0.015 ) , but neither vegetable - nor fish-derived proteins were found to influence inflammatory status .


Our results suggest that the type of protein consumed ( more than the total protein consumed ) within an energy-restricted diet influences the inflammation status associated with obesity-related comorbidities .


Loneliness enhances risk for episodic memory declines over time .


Omega-3 supplementation can improve cognitive function for people experiencing mild cognitive difficulties .


Accordingly , we explored whether omega-3 supplementation would attenuate loneliness-related episodic memory problems .


Participants ( n = 138 ) from a parent randomized controlled trial were randomized to the placebo , 1.25 grams/d of omega-3 , or 2.50 grams/d of omega-3 conditions for a 4-month period .


They completed a baseline loneliness questionnaire and a battery of cognitive tests both at baseline and at the end of the randomized controlled trial .


After adjustment for baseline verbal episodic memory scores , lonelier people within the placebo condition had poorer verbal episodic memory postsupplementation , as measured by immediate ( b = -0.28 , t ( 117 ) = -2.62 , p = .010 ) and long-delay ( b = -0.06 , t ( 116 ) = -2.07 , p = .040 ) free recall , than their less lonely counterparts .


This effect was not observed in the 1.25 - and 2.50-grams / d supplementation groups ( all p values > .10 ) .


The plasma omega-6 : omega-3 ratio data mirrored these results .


There were no loneliness-related effects of omega-3 supplementation on short-delay recall or the other cognitive tests ( all p values > .32 ) .


These results suggest that omega-3 supplementation attenuates loneliness-related verbal episodic memory declines over time and support the use of exploring novel interventions for treating episodic memory problems among lonely people .


clinicaltrials.gov Identifier : NCT00385723 .


To evaluate the effect of surgical factors on postoperative astigmatism in infants undergoing cataract extraction with or without intraocular lens ( IOL ) implantation .


The Infant Aphakia Treatment Study is a multicenter clinical trial in which 114 infants with unilateral congenital cataracts were randomized to undergo cataract extraction with IOL placement or contact lens aphakic correction .


Surgical videos were reviewed with regard to incision type and location , whether the incision was extended , the number of sutures placed , and technique of closure .


Corneal astigmatism was measured using a handheld keratometer prior to surgery and at 1 year of age .


Corneal astigmatism decreased from a mean of 1.92 D at baseline to 1.62 D at age 1 year in the contact lens group but remained almost unchanged from 2.00 D to 2.09 D in the IOL group ( P = 0.023 ) .


There was no statistical difference between the amount of corneal astigmatism with regard to incision type ( P = 0.214 ) and no increase in astigmatism with extension of the incision to facilitate IOL placement ( P = 0.849 ) at 1 year .


The number of sutures and technique of closure did not influence the amount of astigmatism at 1 year .


At the age of 1 year following cataract extraction in infants , contact lens correction and the lack of IOL placement are associated with a significant decrease in postoperative corneal astigmatism compared to IOL placement .


No other surgical factors considered in this study had a statistically significant effect on corneal astigmatism .


This study assessed the efficacy of a 38-hour communication skills training program designed to train a multidisciplinary radiotherapy team .


Four radiotherapy teams were randomly assigned to a training program or a waiting list .


Assessments were scheduled at baseline and after training for the training group and at baseline and 4 months later for the waiting list group .


Assessments included an audio recording of a radiotherapy planning session to assess team members ' communication skills and expression of concerns of patients with breast cancer ( analyzed with content analysis software ) and an adapted European Organisation for Research and Treatment of Cancer satisfaction with care questionnaire completed by patients at the end of radiotherapy .


Two hundred thirty-seven radiotherapy planning sessions were recorded .


Compared with members of the untrained teams , members of the trained teams acquired , over time , more assessment skills ( P = .003 ) and more supportive skills ( P = .050 ) and provided more setting information ( P = .010 ) .


Over time , patients interacting with members of the trained teams asked more open questions ( P = .022 ) , expressed more emotional words ( P = .025 ) , and exhibited a higher satisfaction level regarding nurses ' interventions ( P = .028 ) .


The 38-hour training program facilitated transfer of team member learned communication skills to the clinical practice and improved patients ' satisfaction with care .


Although selective serotonin reuptake inhibitors are now established as first-line pharmacotherapy for social anxiety disorder ( SAD ) , other agents with different mechanisms have shown promise in treating SAD .


The aim of this study was to examine the efficacy and safety of tandospirone in treating adolescents with SAD .


Adolescent patients meeting the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition ( DSM-IV ) criteria for SAD were randomly assigned ( 1:1 ) to open-label treatment with either tandospirone or sertraline for 8weeks .


The primary outcome measures were changes from baseline in the Hamilton Anxiety ( HAM-A ) scale and response using the Clinical Global Impression of Improvement ( CGI-I ) scale .


The adjusted mean change in HAM-A scores from baseline was indicating a significant improvement over baseline in both treatment arms ( p < 0.0001 ) .


The mean CGI-I scale score at week was with no significant difference between the two arms ( p = 0.42 ) .


Rates of response were 48.6 % for tandospirone and 55.6 % for sertraline using the CGI-I .


Response rates were 37.1 % for tandospirone and 41.7 % for sertraline using a HAM-A response criterion ( 50 % reduction ) .


The adjusted mean change in Social Phobia Inventory scores from baseline was indicating a significant improvement over baseline in both treatment arms ( p < 0.0001 ) .


Tandospirone is safe and effective and appears non-inferior to sertraline for SAD in youths .


The CAREvent Public Access Resuscitator ( PAR ) is an electronic , oxygen-driven cardiopulmonary resuscitation ( CPR ) device allowing volume-controlled ventilation with a face mask and guiding the rescuer through the resuscitation with voice prompts and visual indications .


We hypothesized that 1 year after initial training , the efficacy of ventilation skills ( primary outcome ) and compression skills ( secondary outcome ) by first responders using the PAR would be superior compared with CPR with only a face mask .


Seventy-one first responders were randomized to a group using the PAR ( n = 35 ) and a control group using only a face mask ( n = 36 ) .


CPR skills were assessed immediately after training and after 3 , 7 and 12 months using a Skill Reporter manikin .


Differences between groups over time and the interaction between time and groups were assessed using repeated measures models .


Results are reported as mean values and number of participants with good ventilation or compression skills .


Twelve months after training , there were more PAR users with adequate tidal volume than face mask users .


Other ventilations skills did not differ between groups .


There were more PAR users with an adequate number of compressions and with good hand position .


Skill decay over 12 months did not differ between groups , except for hand position , where no decline was observed in the PAR group .


Compared with the face mask , PAR improved tidal volume , compressions per minute and hand position in a manikin setting .


Metatarsus adductus is a common pediatric foot deformity related to intrauterine molding .


It is usually a mild deformity that responds well to simple observation or minimal treatment with a home program of stretching .


Resistant cases may need a more aggressive approach such as serial casting or special bracing to avoid the need for surgical intervention .


We compared clinical outcomes using serial casting with orthoses for resistant metatarsus adductus .


We prospectively treated 27 infants ( 43 feet ) between the ages 3 and 9 months who failed home stretching treatment .


Patients were randomized to either serial plaster casting or Bebax orthoses .


Footprints and simulated weight-bearing anteroposterior and lateral view radiographs were made at entry and follow-up .


There was no statistical difference between casting and Bebax for the following parameters : age at study entry , length of treatment , number of clinic visits , follow-up , and follow-up maintenance treatments .


Both groups showed improvement in footprint and radiographic measurements post-treatment , without worsening of heel valgus .


The Bebax group had greater improvement in the footprint heel bisector measurement than the casting group .


The Bebax treatment requires more active parental cooperation .


A simulated cost analysis of materials and office visit charges , however , revealed that Bebax treatment was significantly less expensive , about half the cost of casting .


Because of the cost savings and virtually identical clinical results , we recommend the Bebax orthosis for resistant metatarsus in pre-walking infants with parents who are compliant .


Other considerations include specific insurance plans , which may pay for casts but not orthoses .


The aim was to compare the hemodynamic parameters , intubation times , upper airway trauma and postoperative sore throat scores of the patients with normal airway anatomy , intubated with the Airtraq , Macintosh laryngoscope and fiberoptic bronchoscope , by experienced anesthesiologists .


Ninety patients , scheduled to undergo elective surgery under general anesthesia were randomly divided into three groups ( n = 30 ) : Group A : Airtraq laryngoscope , Group M : Macintosh laryngoscope and Group FB : fiberoptic bronchoscope .


The time to intubation and success rates were recorded .


The hemodynamic parameters before and one minute after the anesthesia induction were recorded and the measurements were repeated 3 , 4 and 5 minutes after the endotracheal intubation .


The postoperative sore throat scores and signs of any trauma were also recorded .


Mean arterial blood pressure and heart rate were not significantly different between the three groups .


The mean intubation time interval did not differ between groups .


Highest postoperative sore throat scores were recorded at the 6th hour post extubation .


The scores were 37.6 + / - 20.9 in Group A , 13.3 + / - 16.8 in Group M and 13.6 + / - 14.0 in Group FB .


The scores in Group A were significantly higher compared to other groups .


The number of patients requiring additional analgesia to relieve sore throat was also significantly higher in Group A.


The Airtraq laryngoscope seems to be a more traumatic airway device in the routine endotracheal intubation compared to Macintosh laryngoscope and fiberoptic bronchoscope , when used by experienced anesthesiologists .


It also does not offer advantage over the first-attempt success rates , the intubation times and hemodynamic parameters .


Oncostatin M ( OSM ) has been implicated in the pathophysiology of rheumatoid arthritis ( RA ) through its effect on inflammation and joint damage .


GSK315234 is a humanised anti-OSM Immunoglobulin G1 ( IgG1 ) monoclonal antibody ( mAb ) .


This 3-part study examines the safety , tolerability and efficacy of GSK315234 in patients with active RA .


This was a 3-part ( Parts A , B and C ) , multicenter study .


Part A and Part B were randomised , double-blind , placebo-controlled , Bayesian adaptive dose finding studies to investigate the safety , tolerability , efficacy , pharmacokinetics and pharmacodynamics of single ( Part A ) and 3 repeat ( Part B ) intravenous infusions of GSK315234 in patients with active RA on a background of methotrexate ( MTX ) .


Part C was a single dose , randomised , single-blind , placebo-controlled study to assess subcutaneously administered GSK315234 to patients with active RA on a background of MTX .


The primary endpoint of the study was mean change in DAS28 at Day 28 in Part A and Day 56 in Part B and C. All patients receiving at least one dose of GSK315234 were included in safety analysis .


In Part A , there were statistically significant differences in DAS28 between 3 mg/kg and placebo at Day 56 , 84 and 91 .


There was also a statistically significant difference in DAS28 between 0.3 mg/kg , 3 mg/kg and 10 mg/kg , as compared to placebo , at Day 84 .


Although these changes were small and occurred late , they supported progression to Part B and C to determine the therapeutic potential of GSK315234 .


For Part B , no significant difference was observed between 6 mg/kg and placebo .


For Part C , a statistically significant difference in DAS28 was observed at Day 40 , Day 84 and Day 100 between the 500 mg subcutaneous group , as compared to placebo .


No significant findings were observed at any of the time points for EULAR response criteria , ACR20 , ACR50 or ACR70 .


An exploratory analysis of clinical , pharmacokinetic and pharmacodynamics data suggests the lack of efficacy may be due to moderate binding affinity and rapid off-rate of GSK315234 as compared to the higher affinity OSM receptor causing a protein carrier effect prolonging the half life of OSM due to accumulation of the OSM/antibody complex in the serum and synovial fluid .


Our data highlighted the importance of binding affinity and off-rate effect of a mAb to fully neutralize the target and how this may influence its efficacy and potentially worsen disease activity .


Using an anti-OSM mAb with high affinity should test this hypothesis and examine the potential of OSM as a therapeutic target in RA .


ClinicalTrials.gov no : NCT00674635 .


Screening can reduce colorectal cancer ( CRC ) incidence and mortality .


However , screening is underutilized in vulnerable patient populations , particularly among Latinos .


Patient-directed decision aids can increase CRC screening knowledge , self-efficacy , and intent ; however , their effect on actual screening test completion tends to be modest .


This is probably because decision aids do not address some of the patient-specific barriers that prevent successful completion of CRC screening in these populations .


These individual barriers might be addressed though patient navigation interventions .


This study will test a combined decision aid and patient navigator intervention on screening completion in diverse populations of vulnerable primary care patients .


We will conduct a multisite , randomized controlled trial with patient-level randomization .


Planned enrollment is 300 patients aged 50 to 75years at average CRC risk presenting for appointments at two primary clinics in North Carolina and New Mexico .


Intervention participants will view a video decision aid immediately before the clinic visit .


The 14 to 16minute video presents information about fecal occult blood tests and colonoscopy and will be viewed on a portable computer tablet in English or Spanish .


Clinic-based patient navigators are bilingual and bicultural and will provide both face-to-face and telephone-based navigation .


Control participants will view an unrelated food safety video and receive usual care .


The primary outcome is completion of a CRC screening test at six months .


Planned subgroup analyses include examining intervention effectiveness in Latinos , who will be oversampled .


Secondarily , the trial will evaluate the intervention effects on knowledge of CRC screening , self-efficacy , intent , and patient-provider communication .


The study will also examine whether patient ethnicity , acculturation , language preference , or health insurance status moderate the intervention effect on CRC screening .


This pragmatic randomized controlled trial will test a combined decision aid and patient navigator intervention targeting CRC screening completion .


Findings from this trial may inform future interventions and implementation policies designed to promote CRC screening in vulnerable patient populations and to reduce screening disparities .


ClinicalTrials.gov NCT02054598 .


Diarrhoea and pneumonia contribute 30 % of deaths in children under 5 in Pakistan .