CO@/t slope ) during the first minute of recovery after maximal exercise .


The COM group had a greater improvement in the absolute and the percentage difference of ( Equation is included in full-text article . )


E ( P = @ and P = @ , respectively ) and respiratory rate ( P = @ and P = @ , respectively ) during the first minute of recovery period after exercise compared with the AIT group alone .


No significant changes were noted for VT measurements .


A significant increase in ( Equation is included in full-text article . )


CO@/t slope was observed in COM compared with the AIT group ( P = @ ) .


There was a trend for a greater increase in ( Equation is included in full-text article . )


O@/t slope in the COM group ( P = @ ) .


The addition of strength training to AIT induces significant beneficial effects in terms of ventilatory and metabolic recovery kinetics than AIT alone in CHF patients , possibly indicating greater ventilatory efficiency and metabolic improvement .


The DBCG-IMN is a nationwide population-based cohort study on the effect of internal mammary node radiotherapy ( IMN-RT ) in patients with node positive early breast cancer .


Due to the risk of RT-induced heart disease , only patients with right-sided breast cancer received IMN-RT , whereas patients with left-sided breast cancer did not .


At seven-year median follow-up , a @ % gain in overall survival with IMN-RT has been reported .


This study estimates IMN doses and doses to organs at risk ( OAR ) in patients from the DBCG-IMN .


Numbers needed to harm ( NNH ) if patients with left-sided breast cancer had received IMN-RT are compared to the number needed to treat ( NNT ) .


Ten percent of CT-guided treatment plans from the DBCG-IMN patients were selected randomly .


IMNs and OAR were contoured in @ planning CT scans .


Dose distributions were re-calculated .


IMNs and OAR dose estimates were compared in right-sided versus left-sided breast cancer patients .


In six left-sided patients , IMN-RT was simulated , and OAR doses were compared to those in the original plan .


The NNH resulting from the change in mean heart dose ( MHD ) was calculated using a published model for risk of RT-related ischemic heart death .


In original plans , the absolute difference between right - and left-sided V@ % to the IMNs was @ % -LSB- @ % confidence interval ( @ % ; @ % ) , p < @ -RSB- .


Heart doses were higher in left-sided plans .


With IMN-RT simulation without regard to OAR constraints , MHD increased @ Gy ( @ Gy ; @ Gy ) , p < @ .


Resulting NNHs from ischemic heart death were consistently larger than the NNT with IMN-RT .


Refraining from IMN-RT on the left side may have spared some ischemic heart deaths .


Assuming left-sided patients benefit as much from IMN-RT as right-sided patients , the benefits from IMN-RT outweigh the costs in terms of ischemic heart death .


To investigate the impact and mechanisms of vitamin D deficiency ( VDD ) on the outcome of elderly patients with diffuse large B-cell lymphoma ( DLBCL ) .


Three hundred fifty-nine pretreatment @-hydroxyvitamin D@ ( @ -LSB- OH -RSB- D@ ) serum levels from the RICOVER-@ study ( Six Versus Eight Cycles of Biweekly CHOP-@ With or Without Rituximab in Elderly Patients With Aggressive CD@ + B-Cell Lymphomas ) and @ from the RICOVER-noRTh study ( an amendment to the RICOVER-@ study in which patients received six cycles of cyclophosphamide , doxorubicin , vincristine , and prednisone administered at an interval of @ weeks plus two cycles of rituximab -LSB- R-CHOP-@ -RSB- , but without radiotherapy ) were determined by chemoluminescent immunoassay .


Rituximab-mediated cellular cytotoxicity ( RMCC ) was assessed by lactate dehydrogenase release assay of CD@ + Daudi cells .


RICOVER-@ patients with VDD ( @ ng/mL ) and vitamin D levels more than @ ng/mL treated with rituximab had @-year event-free survival ( EFS ) of @ % and @ % and @-year overall survival ( OS ) of @ % and @ % , respectively .


These differences were significant in a multivariable analysis adjusting for International Prognostic Index risk factors with a hazard ratio ( HR ) of @ ( P = @ ) for EFS and @ ( P = @ ) for OS .


EFS was not significantly different in patients with vitamin D levels @ or more than @ ng/mL ( HR , @ ; P = @ ) treated without rituximab .


This was confirmed in an independent validation set of @ RICOVER-noRTh patients .


RMCC increased significantly ( P < @ ) in seven of seven individuals with VDD after substitution and normalization of their vitamin D levels .


VDD is a risk factor for elderly patients with DLBCL treated with R-CHOP .


That VDD impairs RMCC and substitution improves RMCC strongly suggests that vitamin D substitution enhances rituximab efficacy , which must be confirmed in appropriately designed prospective trials addressing VDD and substitution not only in DLBCL , but also in malignancies treated with other antibodies , of which the major mechanism of action is antibody-dependent cellular cytotoxicity ( eg , trastuzumab in breast cancer and cetuximab in colorectal cancer ) .


Several additives have been suggested to enhance analgesic effect of local anesthetic agents to decrease the adverse effects of them and increase the degree of satisfaction .


We designed this randomized double-blind controlled study to evaluate the analgesic efficacy of the neostigmine added to bupivacaine using spinal anesthesia in patients undergoing lower limb orthopedic surgery .


Sixty patients @-@ yr old American Society of Anesthesiologists ( ASA ) physical status I or II , scheduled for femur surgery under spinal anesthesia , were recruited in a prospective , double-blinded , randomized way .


The patients were randomly allocated to one of two groups of @ each .


The neostigmine group ( group N ) received bupivacaine @ mg combined with @ g neostigmine , and the placebo group ( group C ) received bupivacaine @ mg combined with @ ml distilled water ( intrathecally ) @ minutes prior to surgery .


The time to the first analgesic request , analgesic requirement in the first @ hours after surgery , the duration of sensory and motor blockade , the incidence of adverse effects such as nausea , vomiting , hypotension , ephedrine requirements , bradycardia , and hypoxemia were recorded .


Patients receiving neostigmine had a significantly prolonged duration of motor block ( C@ % CI @ to @ ; P < @ ) and sensory block ( C@ % CI @ to @ ; P < @ ) compared to the control group .


The difference of the mean time to the first analgesic request was also significantly longer in neostigmine group ( C@ % CI @ to @ ; P < @ ) .


The total analgesic consumption during the first @ hours after surgery was devoid of any significant difference between groups N and C ( p = @ ) .


The two groups were not significantly different in terms of intraoperative and postoperative side effects .


Intrathecal neostigmine @ g with bupivacaine caused a prolonged time to the first analgesic request and its use was not associated with any side effects .


To analyze pomegranate extract ( POMx ) effects on serum and on human HMDM atherogenicity in simvastatin - treated hypercholesterolemic patients .


Patients were randomly assigned to receive either simvastatin ( @ mg/day ) + vegan placebo pill ( n = @ ) , or simvastatin ( @ mg/day ) + POMx pill ( @g/day , n = @ ) .


Fasting blood samples were collected at baseline and after @ and @ months of therapy .


HMDM were collected from @ patients in each group at baseline and after @ months of therapy , as well as from @ healthy subjects .


After @ months of therapy , serum LDL-cholesterol levels significantly decreased , by @ % , in the simvastatin + placebo group , and by @ % in the simvastatin + POMx group .


Simvastatin + POMx therapy increased serum thiols concentration by @ % .


Patients ' HMDM reactive oxygen species ( ROS ) levels were significantly increased , by @ % , vs. healthy subjects HMDM .


After @ months of therapy , HMDM ROS levels decreased by @ % in the simvastatin + placebo group , whereas in the simvastatin + POMx group it decreased by up to @ % .


A novel finding was the triglycerides levels in the patients ' HMDM at baseline which were significantly higher , by @ % , vs. healthy subjects HMDM .


The simvastatin + POMx , but not the simvastatin + placebo therapy , significantly reduced macrophage triglycerides content by @ % , vs. baseline levels .


In addition , whereas the simvastatin + placebo therapy significantly decreased the patients ' HMDM cholesterol biosynthesis rate by @ % , the simvastatin + POMx therapy further decreased it , by @ % .


The addition of POMx to simvastatin therapy in hypercholesterolemic patients improved oxidative stress and lipid status in the patient 's serum and in their HMDM .


These anti-atherogenic effects could reduce the risk for atherosclerosis development .


To estimate the incremental cost-effectiveness of tuberculosis ( TB ) screening and isoniazid preventive therapy ( IPT ) among human immunodeficiency virus ( HIV ) infected adults in Rio de Janeiro , Brazil .


We used decision analysis , populated by data from a cluster-randomized trial , to project the costs ( in @ USD ) and effectiveness ( in disability-adjusted life years -LSB- DALYs -RSB- averted ) of training health care workers to implement the tuberculin skin test ( TST ) , followed by IPT for TST-positive patients with no evidence of active TB .


This intervention was compared to a baseline of usual care .


We used time horizons of @ year for the intervention and @ years for disease outcomes , with all future DALYs and medical costs discounted at @ % per year .


Providing this intervention to @ people would avert @ discounted DALYs ( @ undiscounted DALYs ) .


The median estimated incremental cost-effectiveness ratio was $ @ ( IQR $ @ - $ @ ) per DALY averted , less than Brazil 's @ per capita gross domestic product ( GDP ) of $ @,@ .


Results were most sensitive to the cost of providing the training .


Training health care workers to screen HIV-infected adults with TST and provide IPT to those with latent tuberculous infection can be considered cost-effective relative to the Brazilian GDP per capita .


The present study is an open-label extension ( OLE ) aimed at evaluating the effect of @ mg/day of phosphatidylserine enriched with docosahexaenoic acid ( PS-DHA ) on cognitive performance in nondemented elderly individuals with memory complaints .


From the participants who completed the core study , @ continued with a @-week OLE .


Efficacy was assessed using a computerized tool and the Clinical Global Impression of Change ( CGI-C ) rating scale .


A significant improvement in sustained attention and memory recognition was observed in the PS-DHA nave group , while the PS-DHA continuers maintained their cognitive status .


Additionally , a significant improvement in CGI-C was observed in the nave group .


The results demonstrate that consumption of @ mg/day of PS-DHA might be associated with improving or maintaining cognitive status in elderly subjects with memory complaints .


To evaluate the effects of terazosin and tolterodine on ureteral stent discomfort .


Of @ patients assessed for eligibility , @ patients were randomly assigned to receive placebo , @ mg of terazosin twice daily , @ mg of tolterodine daily , or both terazosin plus tolterodine during the stenting period .


Prior to stenting and at stent removal , the International Prostate Symptom Score ( IPSS ) , the IPSS quality of life ( QoL ) subscore and the Visual Analog Scale for Pain were determined .


The patients also reported their analgesic use during the stenting period .


Ninety-four patients completed the study .


We noted significant decreases in the total IPSS scores ( p = @ ) , irritative subscore ( p = @ ) , QoL ( p = @ ) , flank pain ( p = @ ) , voiding pain ( p = @ ) and amount of analgesics used ( p = @ ) in the groups .


However , neither the obstructive subscore nor the suprapubic pain improved significantly ( p = @ and p = @ , respectively ) .


The patients receiving terazosin plus tolterodine experienced significant reductions in the total IPSS , irritative symptoms , QoL , flank pain , voiding pain and decreased analgesics use compared with those patients receiving placebo .


However , compared with placebo , terazosin monotherapy did not affect pain levels , and tolterodine monotherapy did not improve QoL , flank pain or analgesics use .


Terazosin plus tolterodine improves ureteral stent-related complications , including irritative symptoms , the amount of analgesics used , QoL , flank pain and voiding pain but does not decrease obstructive symptoms or suprapubic pain .


This trial was registered at www.clinicaltrials.gov as NCT@ .


To assess the effects of fentanyl administered before induction of anesthesia on movement and airway responses during desflurane anesthesia via the Laryngeal Mask Airway ( LMA ) .


Randomized , double-blinded , controlled trial .


Tertiary-care academic center .


@ adult , ASA physical status @ , @ , and @ patients undergoing ambulatory surgery .


Patients were administered fentanyl @ g/kg ( n = @ ) or saline ( n = @ ) @ to @ minutes before induction with propofol @-@ @ mg/kg intravenously ( IV ) , followed by LMA placement .


Anesthesia was maintained with desflurane titrated to a bispectral index ( BIS ) of @-@ and @ % nitrous oxide in oxygen , and fentanyl @ g boluses were titrated to respiratory rate .


Apnea occurrence and duration of manual ventilation , as well as frequency and severity of movement , coughing , breath holding , and laryngospasm were recorded .


Two patients in each group were excluded from analysis .


The fentanyl pretreatment group had a higher frequency of apnea ( @ % vs @ % ; P = @ ) and longer duration of manual ventilation ( @ -LSB- interquartile range ( IQR ) , @-@ -RSB- min vs @ -LSB- @-@ @ -RSB- min ; P < @ ) at induction .


In contrast , the fentanyl pretreatment group had a lower frequency of movements ( @ % vs @ % ;P = @ ) .


The rates of intraoperative breath holding ( @ % vs @ % ) and laryngospasm ( @ % vs @ % ) in the two groups were similar .


All subjects experiencing laryngospasm were smokers .


Adjusting for smoking status did not affect the differences noted in apnea , duration of manual ventilation , or movement between groups ; however , coughing occurrence was statistically higher in the placebo group ( P = @ ) .


Preinduction fentanyl increased the frequency of apnea at induction and duration of manual ventilation , but reduced the frequency of movements .


In addition , it reduced intraoperative coughing in smokers .


Acute kidney injury , a common complication of surgery , is associated with poor outcomes and high health care costs .


Some studies suggest aspirin or clonidine administered during the perioperative period reduces the risk of acute kidney injury ; however , these effects are uncertain and each intervention has the potential for harm .


To determine whether aspirin compared with placebo , and clonidine compared with placebo , alters the risk of perioperative acute kidney injury .


A @ factorial randomized , blinded , clinical trial of @ patients undergoing noncardiac surgery from @ centers in @ countries with consecutive patients enrolled between January @ and December @ .


Patients were assigned to take aspirin ( @ mg ) or placebo @ to @ hours before surgery and then aspirin ( @ mg ) or placebo daily up to @ days after surgery , and were assigned to take oral clonidine ( @ mg ) or placebo @ to @ hours before surgery , and then a transdermal clonidine patch ( which provided clonidine at @ mg/d ) or placebo patch that remained until @ hours after surgery .


Acute kidney injury was primarily defined as an increase in serum creatinine concentration from the preoperative concentration by either an increase of @ mg/dL or greater ( @ mol/L ) within @ hours of surgery or an increase of @ % or greater within @ days of surgery .


Aspirin ( n = @ ) vs placebo ( n = @ ) did not alter the risk of acute kidney injury ( @ % vs @ % , respectively ; adjusted relative risk , @ ; @ % CI , @-@ @ ) .


Clonidine ( n = @ ) vs placebo ( n = @ ) did not alter the risk of acute kidney injury ( @ % vs @ % , respectively ; adjusted relative risk , @ ; @ % CI , @-@ @ ) .


Aspirin increased the risk of major bleeding .


In a post hoc analysis , major bleeding was associated with a greater risk of subsequent acute kidney injury ( @ % when bleeding was present vs @ % when bleeding was absent ; adjusted hazard ratio , @ ; @ % CI , @-@ @ ) .


Similarly , clonidine increased the risk of clinically important hypotension .


In a post hoc analysis , clinically important hypotension was associated with a greater risk of subsequent acute kidney injury ( @ % when hypotension was present vs @ % when hypotension was absent ; adjusted hazard ratio , @ ; @ % CI , @-@ @ ) .


Among patients undergoing major noncardiac surgery , neither aspirin nor clonidine administered perioperatively reduced the risk of acute kidney injury .


To study the effect of Yinxieling decoction on PASI , TNF - and IL-@ in patients with psoriasis vulgaris .


A total of @ cases of psoriasis vulgaris were divided into @ groups according to syndrome differentiation of TCM and randomized controlled method : wind heat syndrome group ( group A ) , blood stasis syndrome group ( group B ) , blood dryness syndrome group ( group C ) and control group ( group D ) ( n = @ per group ) .


Patients in observation groups were treated with Yinxieling decoction , while patients in control group were treated by placebo for @ weeks .


Levels of TNF - and IL-@ were determined before treatment , @ and @ weeks after treatment .


psoriasis area and severity index score was also performed before and after treatment .


psoriasis area and severity index score and serum level of TNF - , IL-@ were significantly decreased in all groups .


The decrease in three observation groups was more significant ( P < @ or P < @ ) , and the decrease in wind heat syndrome group was the most significant ( P < @ ) .


psoriasis area and severity index was positively correlated with TNF - and IL-@ , respectively ( P < @ ) .


Yinxieling decoction has therapeutical effect on psoriasis vulgaris via regulating TNF - and IL-@ .


To identify baseline characteristics of women with unexplained infertility to determine whether treatment with an aromatase inhibitor will result in a lower rate of multiple gestations than current standard ovulation induction medications .


Randomized , prospective clinical trial .


Multicenter university-based clinical practices .


A total of @ couples with unexplained infertility .


Collection of baseline demographics , blood samples , and ultrasonographic assessments .


Demographic , laboratory , imaging , and survey characteristics .


Demographic characteristics of women receiving clomiphene citrate ( CC ) , letrozole , or gonadotropins for ovarian stimulation were very consistent .


Their mean age was @ @ years and infertility duration was @ @ months , with @ % primary infertility .


More than one-third of the women were current or past smokers .


The mean body mass index ( BMI ) was @ and mean antimllerian hormone level was @ ; only @ women ( @ % ) had antral follicle counts of < @ .


Similar observations were identified for hormonal profiles , ultrasound characterization of the ovaries , semen parameters , and quality of life assessments in both male and female partners .


The cause of infertility in the couples recruited to this treatment trial is elusive , as the women were regularly ovulating and had evidence of good ovarian reserve both by basal FSH , antimllerian hormone levels , and antral follicle counts ; the male partners had normal semen parameters .


The three treatment groups have common baseline characteristics , thereby providing comparable patient populations for testing the hypothesis that use of letrozole for ovarian stimulation can reduce the rates of multiples from that observed with gonadotropin and CC treatment .


To evaluate the efficacy and safety of AM-@ , a c-Jun N-terminal Kinase ( JNK ) ligand , in patients with acute sensorineural hearing loss ( ASNHL ) .


Prospective , double-blind , randomized , placebo-controlled study with follow-up visits on Days @ , @ , @ , and @ .


Twenty-five European sites ( academic tertiary referral centers , private ENT practices ) .


Approximately @ patients aged @ to @ years presenting within @ hours after acute acoustic trauma or idiopathic sudden sensorineural hearing loss with mean hearing loss of @ dB or greater at the @ most affected contiguous test frequencies .


Single-dose intratympanic injection of AM-@ ( @ or @ mg/ml ) or placebo ; optionally , oral prednisolone if hearing improvement was less than @ dB at Day @ .


Efficacy was assessed by absolute hearing improvement ( primary end point , Day @ ) , percentage hearing improvement , complete hearing recovery , speech discrimination improvement , and complete tinnitus remission .


Safety was evaluated by the frequency of clinically relevant hearing deterioration and adverse events .


The study failed to demonstrate a treatment benefit for the entire study population because mild-to-moderate ASNHL cases showed unexpectedly strong spontaneous recovery .


In severe-to-profound ASNHL patients ( threshold @ dB ) , AM-@ @ mg/ml showed statistically significant , clinically relevant , and persistent improvements in hearing and speech discrimination and higher tinnitus remission compared with placebo .


The study drug and the intratympanic injections were well tolerated .


The study established proof of concept for AM-@ in the treatment of severe-to-profound ASNHL .


Control for spontaneous hearing recovery is essential for ASNHL studies .


The objective of this study was to assess the @-week virological efficacy of atazanavir/ritonavir ( ATV/r ) monotherapy vs. ATV/r along with two nucleoside reverse transcriptase ( NRTIs ) in HIV-@ treated individuals with HIV-RNA less than @copies/ml .


A multicentre , randomized , open-label , noninferiority trial .


HIV-@ treated individuals on ATV/r @/@mg along with two NRTIs were randomized to receive ATV/r monotherapy or to maintain their antiretroviral regimen .


The primary endpoint was the confirmed viral rebound ( CVR : two consecutive HIV-RNA > @copies/ml ) or treatment discontinuation for any reason .


Individuals who experienced CVR on ATV/r monotherapy reintroduced NRTIs and discontinued the study if HIV-RNA was more than @copies/ml after @ weeks since reintensification .


One hundred and three patients enrolled .


By week @ , @ patients in ATV/r arm and two in ATV/r along with two NRTIs experienced CVR ; four ( @ % ) patients in ATV/r and eight ( @ % ) in ATV/r along with two NRTIs discontinued .


At the @-week primary efficacy analysis ( re-intensification = failure ) , treatment success was @ % in ATV/r arm and @ % in ATV/r along with two NRTIs -LSB- difference -@ % , @ % confidence interval ( @ % CI ) -@ to @ -RSB- .


According to the analysis considering re-intensification is equal to success , treatment success was @ % in ATV/r arm and @ % in the ATV/r along with two NRTIs arm ( difference @ % , @ % CI -@ to @ ) .


At CVR , no mutation was observed in ATV/r arm and reintensification with NRTIs was effective in all individuals .


Overall , Grade @-@ ( P = @ ) and grade @-@ drug-related ( P = @ ) adverse events were less frequent in ATV/r arm .


A significant increase in total and low-density lipoprotein ( LDL ) - cholesterol was observed as well as a significant improvement in high-density lipoprotein ( HDL ) - cholesterol , fasting glucose , liver fibrosis and alkaline phosphatase was observed in ATV/r monotherapy in comparison with ATV/r along with two NRTIs .


ATV/r monotherapy treatment simplification showed lower virological efficacy in comparison with maintaining triple therapy ; NRTIs reintroduction was effective in all the individuals .


The progressive nature of glaucoma and its growing incidence make its therapy an important target for research .


The role of oxidative damage in the pathogenesis of glaucoma makes antioxidants such as saffron extract an attractive target for potential clinical use .


Herein , we evaluate the effect of aqueous saffron extract on intraocular pressure ( IOP ) in eyes with primary open-angle glaucoma ( POAG ) .


Thirty-four eyes of @ clinically stable POAG patients receiving treatment with timolol and dorzolamide eye drops were enrolled in this prospective , comparative , randomized interventional pilot study .


Eligible subjects were randomized to receive @ mg/day aqueous saffron extract orally ( @ subjects , @ eyes ) or placebo ( @ subjects , @ eyes ) for one month as an adjunct to timolol and dorzolamide .


Following treatment , both study groups entered a one-month wash-out period .


The main outcome measure was IOP during treatment and after the wash-out period .


Mean baseline IOP was @ @ versus @ @ mmHg in the saffron and control groups , respectively ( p = @ ) .


After three weeks of treatment , IOP was significantly decreased to @ @ mmHg in the saffron group as compared to @ @ mmHg in the control group ( p = @ ) .


At four weeks , IOP was still significantly lower in the saffron group ( @ @ versus @ @ mmHg , p = @ ) .


At the end of the wash-out period , IOP was @ @ in the saffron group versus @ @ mmHg in the control group ( p = @ ) .


None of the patients experienced side effects during the study and wash-out period .


Oral aqueous saffron extract seems to exert an ocular hypotensive effect in primary open-angle glaucoma .


This effect became evident after three weeks of therapy.The current study was registered at the International Clinical Trials Registry Platform ( ICTRP ) as IRCT@N@ .


To compare standard-of-care grid laser photocoagulation versus intravitreal ranibizumab ( IVR ) versus a combination of both in the treatment of chronic ( > @ months ) macular oedema secondary to branch retinal vein occlusion .


Prospective , randomized , multicentre clinical trial .


Thirty patients with a best-corrected visual acuity ( BCVA ) between @/@ and @/@ were randomized @:@:@ to receive grid laser or three monthly injections of @ mg IVR or both followed by @ months of observation .


Mean change from baseline BCVA at month @ was +@ letters -LSB- laser ; @ logMAR , @ % confidence interval ( -@ ; @ ) -RSB- , +@ letters -LSB- IVR ; @ ( @ ; @ ) -RSB- and +@ letters -LSB- combination ; @ ( @ ; @ ) -RSB- ( IVR versus laser p = @ and IVR versus combination p = @ ) .


At month @ , mean improvement in central retinal thickness ( CRT ) was @ m ( laser ) ( -@ ; @ ) , @ m ( IVR ) ( @ ; -@ ) , and @ m ( @ ; -@ ) ( combination ) ( IVR versus laser p = @ , laser versus combination p = @ ) .


During the observation period , CRT improved in laser -LSB- @ m ( -@ ; @ ) -RSB- , but deteriorated in IVR -LSB- -@ m ( -@ ; -@ ) -RSB- and combination -LSB- -@ m ( -@ ; -@ ) -RSB- ( laser versus IVR p = @ , laser versus combination p = @ ) indicating recurrent oedema .


Less laser retreatments ( at @ weeks ) were required in combination group ( @/@ ) than grid group ( @/@ ) .


Six-month results suggest that ranibizumab may be superior to grid laser in improving visual acuity .


Grid combined with IVR neither enhanced functional and morphological improvement of IVR nor did it prevent or prolong recurrence of oedema .


In IVR groups , CRT increased slowly after stopping injections , whereas improvement in visual acuity was sustained , indicating that morphological changes occur prior to functional impairment .


Recently some plasma biomarkers of inflammation have been recognized as important cardiovascular risk factors .


There is little information about the effects of aerobic exercise training on these biomarkers and the risk of metabolic complications in obese type @ diabetes patients .


To compare the impact of moderate versus mild aerobic exercise training on the inflammatory cytokines in obese type @ diabetic patients .


Fifty obese type @ diabetic patients of both sexes with body mass index ( BMI ) varying from @ to @ kg/m ( @ ) , non smokers , free from respiratory , kidney , liver , metabolic and neurological disorders , participated in this study .


Their age ranged from @ to @ years .


The subjects were included into two equal groups ; the first group ( A ) received moderate aerobic exercise training .


The second group ( B ) received mild aerobic exercise training , three times / week for @ months .


The mean values of leptin , TNF - alpha , IL@ , IL@ , IL@ , HOMA-IR and HBA@c were significantly decreased in group ( A ) and group ( B ) .


Also , there were significant differences between both groups after treatment .


Moderate aerobic exercise training modulates inflammatory cytokines more than mild aerobic exercise training in obese type @ diabetic patients .


Inguinal field block ( IFB ) is a recommended technique for pain control after inguinal hernia repair but is also underused by surgeons .


Currently , there is no decisive evidence on which technique , IFB or spinal anesthesia block ( SAB ) , provides better pain control during the first day after hernia repair .


In this study , we compared ultrasound-guided IFB performed by anesthesiologists and SAB for pain control during the first day after hernia repair .


We compared static and dynamic pain scores measured with a numerical rating scale in @ male patients scheduled for elective unilateral inguinal hernia repair with either ultrasound-guided IFB ( n = @ ) or SAB ( n = @ ) .


Dynamic and static pain at @ hours ( P < @ , r > @ , `` large effect size '' ) , and dynamic pain the morning after operation ( P = @ , r > @ , `` medium effect size '' ) were less in the field block group compared with the SAB group .


Postoperative analgesic consumption was reduced during hospital stay ( P = @ , r > @ , `` large effect size '' ) and for @ postoperative days in the field block group ( P = @ , r > @ , `` medium effect size '' ) .


In this study , ultrasound-guided IFB provided lesser dynamic pain scores during the first postoperative day and reduced use of analgesics for @ week compared with spinal anesthesia after inguinal hernia repair .


Our technique could become a substitute performed by anesthesiologists in settings in which IFB is not performed routinely by surgeons .


Whole-body vibration ( WBV ) training may offer an efficient option to improve physical performance of nursing home residents , but the feasibility of WBV training among frail elderly who require continuous institutional care is still open .


Fifteen nursing home residents ( mean age @years ) with low physical performance ( mean SPPB score @ ) participated in this blinded , randomized controlled pilot trial .


The intervention was either a @week , twice-a-week progressive vibration training with slight exercises done on a side-alternating device or similar sham training without vibration .


Physical performance was assessed with Short Physical Performance Battery ( SPPB ) , Timed Up and Go , walk speed and grip strength tests .


Low @Hz frequency was well tolerated with mean @ % compliance in contrast to higher @Hz ( or @Hz ) frequency , which was poorly ( < @ % ) tolerated .


While treatment effects were not significant , the mean change in SPPB score was @ ( range from -@ to +@ ) in the WBV group in contrast to -@ ( from -@ to +@ ) in the sham group .


Frail nursing home residents form not only a potential but also challenging target group for physical rehabilitation with WBV .


Side-alternating WBV training performed at low @Hz frequency was found generally feasible , whereas higher frequencies appeared formidable .


Nevertheless , it is possible that physical performance of some frail elderly without contraindications to WBV can be improved with this type of rapidly executable physical training .


Preclinical investigations support the use of probiotics in the treatment of hypercholesterolemia , but clinical evidence is often contrasting .


The aim of this study was to evaluate the effects of a probiotic formulation containing three Bifidobacterium strains on lipid profiles in children affected by primary dyslipidemia .


Thirty-eight children with dyslipidemia , ages @ @ y , were enrolled in a randomized , double-blind , placebo-controlled cross-over study .


After a @-wk diet run-in period , the children received probiotics ( B. animalis subspecies lactis MB @ , B. bifidum MB @B , and B. longum subspecies longum BL@ ) or placebo for @ mo. .


After @ mo , wash-out treatments were switched .


Astrict dietary evaluation concerning satured fatty acids and cholesterol content , STEP I diet accordingly , was performed by a dietitian who examined the weekly dietary diary at each visit .


Baseline lipid profile was ( mean SD ) : total cholesterol ( TC ) @ @ mg/dL , high-density lipoprotein cholesterol ( HDL-C ) @ @ mg/dL , triglycerides ( TG ) @ @ mg/dL , and low-density lipoprotein cholesterol ( LDL-C ) @ @ mg/dL .


After @ mo of probiotic treatment , the lipid profile was : TC @ @ mg/dL , HDL-C @ @ mg/dL , TG @ @ mg/dL , and LDL-C @ @ mg/dL .


Compared with placebo , probiotics reduced TC by @ % ( P = @ ) and LDL-C by @ % ( P = @ ) .


No significant dietary change occurred through the study and no relevant adverse effects were observed .


Treatment with a Bifidobacterium probiotic formulation was well tolerated and useful in combination with to diet therapy .


Children with dyslipidemia benefited from this approach , although the results need to be confirmed by larger controlled studies .


Lower concentrations of serum bilirubin , an endogenous antioxidant , have been associated with risk of many smoking-related diseases , including lung cancer and cardiovascular disease , and current smokers are reported to have lower bilirubin levels than nonsmokers and past smokers .


This study evaluates the effects of smoking cessation on bilirubin levels .


In a secondary analysis of a @-week placebo-controlled trial of naltrexone for smoking cessation , indirect and total bilirubin concentrations were evaluated at baseline and following smoking cessation .


Individuals who were continuously abstinent for @ weeks ( n = @ ) were compared to those who were not ( n = @ ) .


Participants reported smoking @ cigarettes daily at baseline and received smoking cessation counseling , @ mg nicotine patch daily , and either placebo or @ of @ doses of naltrexone ( @ , @ , or @mg ) for @ weeks .


Change in indirect and total bilirubin following the quit date was measured at Weeks @ , @ , and @ compared to baseline .


Individuals who were continuously abstinent from smoking , independent of naltrexone condition , showed a significantly greater mean increase in indirect ( ~ unconjugated ) bilirubin ( @ mg/dl , SD = @ ) compared to those who did not ( mean = @ , SD = @ , p = @ ) .


Similar results were obtained for total bilirubin ( p = @ ) .


Smoking cessation is followed by increases in bilirubin concentration that have been associated with lower risk of lung cancer and cardiovascular disease .


Levobupivacaine has less toxic potential on both the cardiovascular and central nervous system and has been widely used for postoperative epidural analgesia in surgical patients .


However , there are few reports on the efficacy of epidural levobupivacaine in outpatients with lumbosacral radiculopathy .


This study was carried out to evaluate the comparative efficacy of levobupivacaine and ropivacaine for epidural block in outpatients with degenerative spinal disease and sciatica .


We studied @ patients ( @ men and @ women ) with degenerative spinal disease and sciatica .


The study was performed in a prospective , randomized , double blind , and crossover fashion .


Treatment room for outpatients .


The epidural block was produced with a caudal approach ( @ % levobupivacaine or @ % ropivacaine , @ mL ) .


The upper level of analgesia , lumbosacral pain , motor blockade , and hemodynamic changes were evaluated by pin prick , visual analogue scale ( VAS ) , Bromage scale , and arterial blood pressure and heart rate at @ , @ , @ , and @ minutes after epidural block , respectively .


The recovery time to mobilization , ambulation , and spontaneous micturition were measured .


There were no significant differences ( P < @ ) in the upper level of analgesia , VAS , and Bromage scale between @ % levobupivacaine and @ % ropivacaine throughout the time course .


There were no significant differences in the recovery times to mobilization , ambulation , and spontaneous micturition between @ % levobupivacaine and @ % ropivacaine .


There were no significant differences in arterial blood pressure and heart rate between the @ trials throughout the time course .


The results showed that @ % levobupivacaine and @ % ropivacaine for epidural block by a caudal approach provide similar lumbosacral pain relief , hemodynamic effects , and the degree and the recovery of motor blockade in outpatients with degenerative spinal disease and sciatica .


Because excess sebum and/or metabolites of sebum induce skin problems , cleansers that can remove those kinds of sebum are sought after .


However , many people , especially who have little facial sebum , are afraid to wash off sebum well because that may induce dry skin .


This concern may be caused by the result that cleansers with a high cleansing ability tend to decrease not only facial sebum but also natural moisturizing factors and intercellular lipids that are essential for cutaneous function .


Recently , we have developed a new cleanser based on sodium laureth carboxylate and alkyl carboxylates ( AEC/soap ) that cleans sebum well without penetrating the stratum corneum .


This trial was aim to clarify the effects of sebum removal by AEC/soap-based cleanser on the induction of dry skin .


We designed a controlled single blind parallel trial .


Thirty female subjects with mild dry skin were assigned randomly to two groups : one group used AEC/soap-based cleanser while the other group kept using their usual facial cleanser twice a day for @weeks in the winter season .


Using a colored artificial sebum mixture , it was demonstrated that this cleanser washed sebum well .


Following usage of this cleanser , their dry skin improved rather than worsen which was indicated by instrumental analysis and visual assessment .


These improvements were recognized by subjects .


These results suggest that AEC/soap-based cleanser washes off facial sebum well , but it has little effect on the induction of dry skin because of less penetration into stratum corneum .


The present study evaluated the effects of pioglitazone treatment on the incidence of primary cardiovascular events in Japanese subjects with type @ diabetes mellitus at high risk of stroke .


A prospective , multicenter , randomized , open label , comparative study was conducted among diabetic patients recruited from @ medical institutions nationwide .


A total of @ patients with hypertension and/or dyslipidemia who had one or more silent cerebral infarcts , advanced carotid atherosclerosis or microalbuminuria at baseline were randomly treated with ( n = @ ) or without pioglitazone ( n = @ ) and observed for a medium of @ days .


The hypertension and dyslipidemia were concurrently treated according to the respective treatment guidelines .


The primary outcome was the time to the first occurrence of a composite of all-cause death , nonfatal cerebral infarction and nonfatal myocardial infarction .


Treatment with pioglitazone resulted in significant reductions in the levels of HbA@c , diastolic blood pressure and LDL-cholesterol and a significant increase in the levels of HDL-cholesterol .


The pioglitazone non-users exhibited a significant reduction in the LDL-cholesterol levels alone .


Primary events were registered during the study period in nine patients in the pioglitazone group and @ patients in the non-pioglitazone group .


The difference in the cumulative incidence of the primary outcome was not significant between the two groups ( @ % per year ) .


Pioglitazone therapy produces immediate and effective improvements in glycemic control , diastolic blood pressure and lipid profiles .


While this study was too underpowered to determine the effects of pioglitazone on the incidence of cardiovascular events , the results indicated that two years of pioglitazone treatment did not produce any statistically significant reductions in the rate of primary cardiovascular events .


Chemotherapy-induced peripheral neuropathy is frequently a dose-limiting factor in cancer treatment and may cause pain and irreversible function loss in cancer survivors .


We tested whether alpha-lipoic acid ( ALA ) could decrease the severity of peripheral neuropathy symptoms in patients undergoing platinum-based chemotherapy .


Cancer patients @ years or older were randomly selected to receive either @ mg ALA or a placebo three times a day orally for @ weeks while receiving chemotherapy regimens including cisplatin or oxaliplatin .


Neuropathy was measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity ( FACT/GOG-Ntx ) scale and the NCI Common Toxicity Criteria for Adverse Events neurotoxicity grades .


Results from timed functional tests and the Brief Pain Inventory ( BPI ) were secondary endpoints .


Seventy of @ ( @ % ) patients completed the study ( @ weeks ) .


Both the ALA and the placebo arms had a comparable drop-out rate .


No statistically significant differences were found between the ALA and the placebo groups for FACT/GOG-Ntx scores , BPI scores , and patients ' functional outcomes .


This strategy of oral ALA administration was ineffective at preventing neurotoxicity caused by oxaliplatin or cisplatin .


High attrition rates due to poor patient compliance and manner of dosage administration in this trial demonstrated a lack of feasibility for this intervention .


Future studies to explore ALA as a neuroprotective agent should take heed of the barriers confronted in this study .


Single procedure success rates of pulmonary vein isolation ( PVI ) in patients with paroxysmal atrial fibrillation ( PAF ) are still unsatisfactory .


In patients with persistent atrial fibrillation ( AF ) , ablation of complex fractionated atrial electrograms ( CFAEs ) after PVI results in improved outcomes .


We aimed to investigate if PAF-patients with intraprocedurally sustained AF after PVI might benefit from additional CFAE ablation .


A total of @ consecutive patients underwent a first catheter ablation procedure of PAF between June @ and December @ .


In most patients , AF was either not inducible or terminated during PVI .


In @ patients ( @ % ) , AF sustained after successful PVI .


These patients were randomized to either cardioversion ( PVI-alone group ; n = @ ) or additional CFAE ablation ( PVI+CFAE group ; n = @ ) and followed up every @-@ months and serial Holter recordings were also obtained .


The primary end point was the recurrence of AF/atrial tachycardia ( AT ) after a blanking period of @ months .


Procedure duration ( @ @ minutes vs @ @ minutes ) , radiofrequency application time ( @ @ minutes vs @ @ minutes ) , and fluoroscopy time ( @ @ minutes vs @ @ minutes ) were longer in the PVI+CFAE group ( all P < @ ) .


In @ of @ patients ( @ % ) in the PVI+CFAE group , ablation terminated AF .


There was no significant group difference with respect to freedom from AF/AT ( @ of @ -LSB- @ % -RSB- vs @ of @ -LSB- @ % -RSB- ; P = @ ) .


Subsequently , @ of @ patients in the PVI-alone group ( @ % ) and @ of @ patients in PVI+CFAE group ( @ % ) underwent repeat ablation ( P = @ ) .


Overall , @ of @ -LSB- @ % -RSB- vs @ of @ -LSB- @ % -RSB- patients ( P = @ ) were free from AF/AT after @ @ vs @ @ ( P = @ ) procedures .


Patients with sustained AF after PVI in a PAF cohort are rare .


Regarding AF/AT recurrence , these patients did not benefit from further CFAE ablation compared to PVI alone , but are exposed to longer procedure duration , fluoroscopy time , and radiofrequency application time .


To assess the prevalence of gastrointestinal toxicity in dogs receiving chemotherapy with vincristine and cyclophosphamide and the efficacy of maropitant citrate ( Cerenia , Zoetis ) in reducing these events .


Dogs receiving chemotherapy with cyclophosphamide or vincristine were randomised to either receive maropitant or not in the period immediately after treatment and for @ days afterwards .


Owners completed a diary of adverse events following treatment .


Adverse events occurred in @/@ ( @ % ) dogs in the vincristine group .


Most of these adverse events were mild and included : lethargy ( @ % ) , appetite loss ( @ % ) , diarrhoea ( @ % ) and vomiting ( @ % ) .


Adverse events occurred in @/@ ( @ % ) dogs treated with cyclophosphamide .


Most of these adverse events were mild and included : lethargy ( @ % ) , diarrhoea ( @ % ) , appetite loss ( @ % ) and vomiting ( @ % ) .


There was no difference in total clinical score , vomiting , diarrhoea , appetite loss or lethargy score between dogs treated with maropitant and non-treated dogs in either the vincristine or cyclophosphamide groups .


Chemotherapy-related side effects are frequent but usually mild in dogs receiving vincristine or cyclophosphamide .


Prophylactic administration of maropitant does not reduce the frequency of adverse events and maropitant should be administered only as required for individual cases .


To report secondary efficacy endpoints of Radiation Therapy Oncology Group protocol @ , primary endpoint analysis of which demonstrated that preoperative radiation therapy ( RT ) with capecitabine plus oxaliplatin achieved a pathologic complete remission prespecified threshold ( @ % ) to merit further study , whereas RT with capecitabine plus irinotecan did not ( @ % ) .


A randomized , phase @ trial evaluated preoperative RT ( @ Gy in @-Gy fractions ) with @ concurrent chemotherapy regimens : ( @ ) capecitabine ( @ mg/m ( @ ) / d Monday-Friday ) plus irinotecan ( @ mg/m ( @ ) / wk @ ) ; and ( @ ) capecitabine ( @ mg/m ( @ ) / d Monday-Friday ) plus oxaliplatin ( @ mg/m ( @ ) / wk @ ) for clinical T@ or T@ rectal cancer .


Surgery was performed @ to @ weeks after chemoradiation , then @ to @ weeks later , adjuvant chemotherapy ( oxaliplatin @ mg/m ( @ ) ; leucovorin @ mg/m ( @ ) ; @-fluorouracil @ mg/m ( @ ) ; @-fluorouracil @ mg/m ( @ ) ) every @ weeks @ .


Disease-free survival ( DFS ) and overall survival ( OS ) were estimated univariately by the Kaplan-Meier method .


Local-regional failure ( LRF ) , distant failure ( DF ) , and second primary failure ( SP ) were estimated by the cumulative incidence method .


No statistical comparisons were made between arms because each was evaluated individually .


A total of @ patients ( median age , @ years ) were treated ; characteristics were similar for both arms .


Median follow-up for RT with capecitabine/irinotecan arm was @ years and for RT with capecitabine/oxaliplatin arm was @ years .


Four-year DFS , OS , LRF , DF , and SP estimates for capecitabine/irinotecan arm were @ % , @ % , @ % , @ % , and @ % , respectively .


The @-year DFS , OS , LRF , DF , and SP failure estimates for capecitabine/oxaliplatin arm were @ % , @ % , @ % , @ % , and @ % , respectively .


Efficacy results for both arms are similar to other reported studies but suggest that pathologic complete remission is an unsuitable surrogate for traditional survival metrics of clinical outcome .


Although it remains uncertain whether the addition of a second cytotoxic agent enhances the effectiveness of fluorouracil plus RT , these results suggest that further study of irinotecan may be warranted .


To investigate the effect of different doses of dexmedetomidine ( Dex ) on early postoperative cognitive dysfunction in elderly patients undergoing laparoscopic surgery for colorectal cancer .


Eighty ASAI-III elderly patients ( over @ years ) were randomized equally into @ groups including a control group without dexmedetomidine and @ dexmedetomidine groups ( groups D@ , D@ , and D@ ) with loading dexmedetomidine doses of @ , @ , and @ g/kg and maintenance doses of @ , @ , and @ gkg ( -@ ) h ( -@ ) , respectively .


Dex was discontinued @ min before the end of surgery .


The time of operation , adverse reactions , time from the end of surgery to spontaneous breathing recovery ( TR ) , time from spontaneous breathing recovery to opening eyes ( TO ) , and time from opening eyes to extubation ( TE ) were recorded .


Mini-Mental State ( MMSE ) test was used to assess the cognitive function @ day before and at @ day and @ days after the operation .


The incidence of postoperative cognitive dysfunction ( POCD ) was significantly lower in groups D@ and D@ than in the control group and group D@ ( P < @ ) .


The incidences of hypotension and bradycardia were the highest in group D@ ( P < @ ) , which also had longer significantly TO and TE than the other @ groups ( P < @ ) .


Dexmedetomidine with a loading dose of @ g/kg followed by maintenance doses of @ and @ gkg ( -@ ) h ( -@ ) ( preferentially @ gkg ( -@ ) h ( -@ ) ) can reduce the incidence of POCD in elderly patients undergoing laparoscopic surgery for colorectal cancer .


The main objective of the current investigation was to compare a single wall puncture to vessel transfixing on the success of radial artery cannulation by resident physicians .


The study was a prospective and randomized investigation .


Twelve anesthesiology residents performed radial arterial insertions in @ patients using both the single wall and vessel transfixing technique in random order .


The primary outcome was successful cannulation of the radial artery in @ or less attempts .


Other data collected included the total number of attempts and total time to catheter cannulation .


Successful radial artery cannulation was achieved in @ % and @ % of patients using the transfixing technique and single wall group , respectively ( difference @ % ; @ % CI , @-@ , P = @ , Fisher exact test ) .


Cannulation was successfully on the first attempt in @ % of the transfixing compared to @ % using the single wall technique ( difference -- @ % ; @ % CI , @-@ , P = @ , Fisher Exact test ) .


The median ( interquartile range ) time to successful cannulation was longer in the transfixing group , @ ( @-@ ) seconds compared to @ ( @-@ ) seconds in the single puncture group ( P = @ , log-rank test ) .


Our findings suggest that there does not appear to be an advantage of the transfixing technique over the single wall puncture method for cannulating the radial artery by resident physicians .


Cannulation was achieved in shorter time using the single wall puncture technique even after accounting for differences between residents and prior levels of experience .


Preclinical studies suggest that growth factors in the early days after stroke improve final outcome .


A prior study found three doses of human choriogonadotropin alfa followed by three doses of erythropoietin to be safe after stroke in humans .


A proof of concept trial ( REGENESIS ) was initiated but placed on regulatory hold during review of an erythropoietin neuroprotective trial .


Due to financial constraints , the trial was largely moved to India , using lower erythropoietin doses , as the REGENESIS-LED trial .


Entry criteria included National Institutes of Health Stroke Scale @-@ , supratentorial ischemic stroke , and @-@h poststroke at start of therapy .


Patients were randomized to three QOD doses of subcutaneous human choriogonadotropin alfa followed by three QD doses of intravenous erythropoietin ( three escalating dose cohorts , @-@ ,@ IU/dose ) vs. placebo .


Primary outcomes were safety and neurological recovery .


The study was halted early by the sponsor after @ enrollees .


There was no significant difference across treatment groups in the proportion of patients experiencing death , serious adverse events , or any adverse event .


There was no significant difference in National Institutes of Health Stroke Scale score change from baseline to Day @ between placebo and active treatment , whether active cohorts were analyzed together or separately , and no exploratory secondary measure of neurological recovery showed a significant difference between groups .


Administration of human choriogonadotropin alfa followed by erythropoietin is safe after a new ischemic stroke .


At the doses studied , placebo and active groups did not differ significantly in neurological recovery .


Study limitations , such as the use of multiple assessors , differences in rehabilitation care , and being underpowered to show efficacy , are discussed .


Anticoagulation prophylaxis for stroke is recommended for at-risk patients with either persistent or paroxysmal atrial fibrillation ( AF ) .


We compared outcomes in patients with persistent vs. paroxysmal AF receiving oral anticoagulation .


Patients randomized in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ( ROCKET-AF ) trial ( n = @ @ ) were grouped by baseline AF category : paroxysmal or persistent .


Multivariable adjustment was performed to compare thrombo-embolic events , bleeding , and death between groups , in high-risk subgroups , and across treatment assignment ( rivaroxaban or warfarin ) .


Of @ @ patients , @ @ ( @ % ) had persistent AF and @ ( @ % ) had paroxysmal AF .


Patients with persistent AF were marginally older ( @ vs. @ , P = @ ) , less likely female ( @ vs. @ % , P < @ ) , and more likely to have previously used vitamin K antagonists ( @ vs. @ % , P < @ ) compared with patients with paroxysmal AF .


In patients randomized to warfarin , time in therapeutic range was similar ( @ vs. @ % , P = @ ) .


Patients with persistent AF had higher adjusted rates of stroke or systemic embolism ( @ vs. @ events per @-patient-years , P = @ ) and all-cause mortality ( @ vs. @ , P = @ ) .


Rates of major bleeding were similar ( @ vs. @ , P = @ ) .


Rates of stroke or systemic embolism in both types of AF did not differ by treatment assignment ( rivaroxaban vs. warfarin , Pinteraction = @ ) .


In patients with AF at moderate-to-high risk of stroke receiving anticoagulation , those with persistent AF have a higher risk of thrombo-embolic events and worse survival compared with paroxysmal AF .


Mental illness is a significant and growing problem in Canadian healthcare organizations , leading to tremendous personal , social and financial costs for individuals , their colleagues , their employers and their patients .


Early and appropriate intervention is needed , but unfortunately , few workers get the help that they need in a timely way due to barriers related to poor mental health literacy , stigma , and inadequate access to mental health services .


Workplace education and training is one promising approach to early identification and support for workers who are struggling .


Little is known , however , about what approach is most effective , particularly in the context of healthcare work .


The purpose of this study is to compare the impact of a customized , contact-based education approach with standard mental health literacy training on the mental health knowledge , stigmatized beliefs and help-seeking/help-outreach behaviors of healthcare employees .


A multi-centre , randomized , two-group parallel group trial design will be adopted .


Two hundred healthcare employees will be randomly assigned to one of two educational interventions : Beyond Silence , a peer-led program customized to the healthcare workplace , and Mental Health First Aid , a standardized literacy based training program .


Pre , post and @-month follow-up surveys will track changes in knowledge ( mental health literacy ) , attitudes towards mental illness , and help-seeking/help-outreach behavior .


An intent-to-treat , repeated measures analysis will be conducted to compare changes in the two groups over time in terms of the primary outcome of behavior change .


Linear regression modeling will be used to explore the extent to which knowledge , and attitudes predict behavior change .


Qualitative interviews with participants and leaders will also be conducted to examine process and implementation of the programs .


This is one of the first experimental studies to compare outcomes of standard mental health literacy training to an intervention with an added anti-stigma component ( using best-practices of contact-based education ) .


Study findings will inform recommendations for designing workplace mental health education to promote early intervention for employees with mental health issues in the context of healthcare work .


Unconscious survivors of out-of-hospital cardiac arrest have a high risk of death or poor neurologic function .


Therapeutic hypothermia is recommended by international guidelines , but the supporting evidence is limited , and the target temperature associated with the best outcome is unknown .


Our objective was to compare two target temperatures , both intended to prevent fever .


In an international trial , we randomly assigned @ unconscious adults after out-of-hospital cardiac arrest of presumed cardiac cause to targeted temperature management at either @C or @C .


The primary outcome was all-cause mortality through the end of the trial .


Secondary outcomes included a composite of poor neurologic function or death at @ days , as evaluated with the Cerebral Performance Category ( CPC ) scale and the modified Rankin scale .


In total , @ patients were included in the primary analysis .


At the end of the trial , @ % of the patients in the @C group ( @ of @ patients ) had died , as compared with @ % of the patients in the @C group ( @ of @ patients ) ( hazard ratio with a temperature of @C , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) .


At the @-day follow-up , @ % of the patients in the @C group had died or had poor neurologic function according to the CPC , as compared with @ % of patients in the @C group ( risk ratio , @ ; @ % CI , @ to @ ; P = @ ) .


In the analysis using the modified Rankin scale , the comparable rate was @ % in both groups ( risk ratio , @ ; @ % CI , @ to @ ; P = @ ) .


The results of analyses adjusted for known prognostic factors were similar .


In unconscious survivors of out-of-hospital cardiac arrest of presumed cardiac cause , hypothermia at a targeted temperature of @C did not confer a benefit as compared with a targeted temperature of @C .


( Funded by the Swedish Heart-Lung Foundation and others ; TTM ClinicalTrials.gov number , NCT@ . )


Dual-process models posit that addictive behaviors are characterized by strong automatic processes that can be assessed with implicit measures .


The present study investigated the potential of a cognitive bias modification paradigm , the Approach-Avoidance Task ( AAT ) , for retraining automatic behavioral tendencies in cigarette smoking .


The study was set up as an online intervention .


After completing an online survey , @ smokers were randomly allocated either to one of two experimental conditions ( AAT ) or a waitlist control group .


Participants responded to different pictures by pushing or pulling the computer mouse , depending on the format of the picture .


Pictures in portrait format depicted smoking-related items and were associated with pushing , pictures in landscape format depicted neutral items and were associated with pulling .


One version of the AAT provided individual feedback after each trial whereas the standard version did not .


After four weeks , participants were re-assessed in an online survey .


Analyses revealed that the standard AAT , in particular , led to a significant reduction in cigarette consumption , cigarette dependence , and compulsive drive ; no effect was found in the control group .


Interpretability of the study is constrained by the fact that no active control condition was applied .


Notwithstanding the limitations , our findings indicate that the AAT might be a feasible instrument to reduce tobacco dependence and can be applied as an online intervention .


Future studies should investigate whether the effects of behavior therapy can be augmented when combined with retraining interventions .


To investigate the safety and adverse event profile of sorafenib plus radioembolization ( Y@ ) compared to Y@ alone in patients awaiting liver transplantation .


@ patients with HCC were randomized to Y@ alone ( Group A ) or Y@ + sorafenib ( Group B ) .


Adverse events , dose reductions , and peri-transplant complications were assessed .


All patients in the sorafenib group necessitated dose reductions .


Seventeen of @ patients underwent liver transplantation ; median time-to-transplant was @ months ( range : @-@ @ ) and similar between groups ( p = @ ) .


In the sorafenib group , there were @/@ peri-transplant ( < @ days ) biliary complications ( p = @ ) and @/@ acute rejections ( p = @ ) ; there were none in the Y@-only group .


Survival rates were @ % ( Group A ) and @ % ( Group B ) at @ years ( p = @ ) .


The addition of sorafenib to Y@ necessitated dose reductions in all patients awaiting transplantation .


Preliminary data suggest that the combination was associated with more peri-transplant biliary complications and potentially trended towards more acute rejections .


Caution should be exercised when considering sorafenib in the transplant setting .


Further investigation is warranted .


The purpose of this prospective randomised trial was to assess whether an intramedullary nail is superior to a sliding hip screw in the treatment of multifragmentary intertrochanteric fractures


Eighty patients with a @-A@ @ or A@ @ Arbeitsgemeinschaft fr Osteosynthesefragen/Orthopaedic Trauma Association ( AO/OTA ) intertrochanteric fracture were randomly allocated to fixation with either the Gamma nail or the AMBI sliding hip screw device .


All patients were followed up at one , three , six and @months postoperatively , except for nine who died .


There was no statistical difference in Parker mobility score between groups .


The Gamma nail group had significantly higher Barthel Index and EuroQol-@D ( EQ-@D ) scores than the AMBI group at @months .


At the same time , the EQ-@D score had returned to its pre-operative values in the Gamma nail group but not in the AMBI group .


There were no differences in mortality , radiation time and hospital stay .


Duration of the operation , incision length and hip pain occurrence were significantly less in the Gamma nail group .


Few failures occur when unstable @-A@ @ and A@ @ AO/OTA fractures are fixed with a sliding hip screw .


Nevertheless , an intramedullary nail seems superior in reconstituting patients to their pre-operative state .


Both trapeziectomy with ligament reconstruction and tendon interposition and trapeziometacarpal arthrodesis are commonly performed procedures for the treatment of trapeziometacarpal osteoarthritis .


The purpose of this study was to compare the outcomes of both treatments for symptomatic osteoarthritis of the thumb trapeziometacarpal joint in a randomized trial .


Women who were forty years of age or older were randomized either to trapeziectomy with ligament reconstruction and tendon interposition or to arthrodesis with plate and screws .


Patients were evaluated preoperatively and at three and twelve months postoperatively with respect to pain , function ( Patient-Rated Wrist/Hand Evaluation -LSB- PRWHE -RSB- and Disabilities of the Arm , Shoulder and Hand -LSB- DASH -RSB- questionnaires ) , joint motion , strength , complication rate , and patient satisfaction .


Forty-three patients were enrolled .


Since we found significantly more moderate and severe complications following arthrodesis compared with trapeziectomy with ligament reconstruction and tendon interposition ( @ % versus @ % ; p = @ ) , the study was prematurely terminated before the sample size necessary to validly compare the two groups was reached .


The higher complication rate for arthrodesis led to an increase in revision surgery ( two of seventeen patients ) .


Significantly more patients in the ligament reconstruction and tendon interposition group ( @ % ) than in the arthrodesis group ( @ % ) indicated they would consider the same surgery again under the same circumstances ( p = @ ) .


In both groups , PRWHE and DASH scores significantly improved over time ; however , comparison of the groups showed that the results were similar .


Women who are forty years or older with trapeziometacarpal osteoarthritis have fewer moderate and severe complications after trapeziectomy with ligament reconstruction and tendon interposition and are more likely to consider the surgery again under the same circumstances than are those who undergo arthrodesis .


Twelve months after surgery , the PRWHE and DASH scores were similar in both groups .


We do not recommend routine use of arthrodesis with plate and screws in the treatment of women who are forty years or older with stage-II or III trapeziometacarpal osteoarthritis .


To determine dose-dependent effects of T administration on voice changes in women with low T levels .


Seventy-one women who have undergone a hysterectomy with or without oophorectomy with total T < @ ng/dL and/or free T < @ pg/mL received a standardized transdermal estradiol regimen during the @-week run-in period and were then randomized to receive weekly im injections of placebo or @ , @ , @ , or @ mg T enanthate for @ weeks .


Total and free T levels were measured by liquid chromatography-tandem mass spectrometry and equilibrium dialysis , respectively .


Voice handicap was measured by self-report using a validated voice handicap index questionnaire at baseline and @ weeks after intervention .


Functional voice testing was performed using the Kay Elemetrics-Computer Speech Lab to determine voice frequency , volume , and harmonics .


Forty-six women with evaluable voice data at baseline and after intervention were included in the analysis .


The five groups were similar at baseline .


Mean on-treatment nadir total T concentrations were @ , @ , @ , @ , and @ ng/dL in the placebo , @ - , @ - , @ - , and @-mg groups , respectively .


Analyses of acoustic voice parameters revealed significant lowering of average pitch in the @ - and @-mg dose groups compared to placebo ( P < @ ) ; these changes in pitch were significantly related to increases in T concentrations .


No significant dose - or concentration-dependent changes in self-reported voice handicap index scores were observed .


Testosterone administration in women with low T levels over @ weeks was associated with dose - and concentration-dependent decreases in average pitch in the higher dose groups .


These changes were seen despite the lack of self-reported changes in voice .


To evaluate the efficacy and safety of ER XIE TING GRANULES in children with acute diarrhea .


A multicenter , randomized , open-label , parallel-controlled clinical trial was carried out in @ hospitals during March @ to July @ .


A total of @ children with acute diarrhea were enrolled and divided randomly into two groups and treated with ER XIE TING GRANULES ( treatment group ) and smectite powder ( control group ) .


The therapeutic efficacy and adverse drug reactions were evaluated after three-day and seven-day therapy.Superiority or non-inferiority test was done for effectiveness of the treatment based on efficacy differ by more than @ % regarded as the superiority .


Totally @ children completed the study , in whom @ children received ER XIE TING GRANULES and @ received smectite powder .


After three-day and seven-day therapy , cure rates and total efficacy rates of the treatment group were @ % , @ % , @ % , and @ % separately and higher than those of control group ( @ % , @ % , @ % , @ % ) ( Z = @ , P < @ ; Z = @ , P < @ ) .


There were @ children with rotavirus infection and in whom @ cases received ER XIE TING GRANULES and @ received smectite powder .


For rotavirus enteritis , cure rates and total efficacy rates of the treatment group after three-day and seven-day therapy were @ % , @ % , @ % , and @ % separately and higher than those of control group ( @ % , @ % , @ % , and @ % ) ( Z = @ , P < @ ; Z = @ , P < @ ) .


The lower limits of the @ % confidence interval of difference of cure rate and total efficacy rates after three-day and seven-day therapy between two groups were less than @ % .


No obvious drug related adverse reactions were found during the study .


ER XIE TING GRANULES has the same effect for treatment of acute diarrhea and rotavirus enteritis in children.No obvious drug related adverse reactions were found .


To evaluate whether nitrofurantoin prophylaxis prevents postoperative urinary tract infection ( UTI ) in patients receiving transurethral catheterization after pelvic reconstructive surgery .


In a randomized , double-blind , placebo-controlled trial , participants undergoing pelvic reconstructive surgery were randomized to @ mg nitrofurantoin or placebo once daily during catheterization if they were : @ ) discharged with a transurethral Foley or performing intermittent self-catheterization ; or @ ) hospitalized overnight with a transurethral Foley .


Our primary outcome was treatment for clinically suspected or culture-proven UTI within @ weeks of surgery .


Statistical analysis was performed by @ and logistic regression .


Assuming @ % power at a P value of @ , @ participants were needed to demonstrate a two-thirds reduction in UTI .


Of @ participants , @ ( @ % ) received nitrofurantoin and @ ( @ % ) received placebo .


There were no significant differences in baseline demographics , intraoperative characteristics , duration and type of catheterization , or postoperative hospitalization , except a lower rate of hysterectomy in the nitrofurantoin group .


Nitrofurantoin prophylaxis did not reduce the risk of UTI treatment within @ weeks of surgery ( @ % UTI with nitrofurantoin compared with @ % UTI with placebo , relative risk @ , @ % confidence interval @-@ @ , P = @ ) .


Urinary tract infection treatment was higher in premenopausal women , lower in diabetics , and increased with longer duration of catheterization .


In logistic regression adjusting for menopause , diabetes , preoperative postvoid residual volume , creatinine clearance , hysterectomy , and duration of catheterization , there was still no difference in UTI with nitrofurantoin as compared with placebo .


Prophylaxis with daily nitrofurantoin during catheterization does not reduce the risk of postoperative UTI in patients receiving short-term transurethral catheterization after pelvic reconstructive surgery .


Statin treatment may impair glucose homeostasis and increase the risk of new-onset diabetes mellitus , although this may depend on the statin , dose and patient population .


We evaluated the effects of pitavastatin @mg/day on glucose homeostasis in patients with metabolic syndrome in the CAPITAIN trial .


Findings were validated in a subset of patients enrolled in PREVAIL-US .


Participants with a well defined metabolic syndrome phenotype were recruited to CAPITAIN to reduce the influence of confounding factors .


Validation and comparison datasets were selected comprising phenotypically similar subsets of individuals enrolled in PREVAIL-US and treated with pitavastatin or pravastatin , respectively .


Mean change from baseline in parameters of glucose homeostasis ( fasting plasma glucose -LSB- FPG -RSB- , glycated hemoglobin -LSB- HbA@c -RSB- , insulin , quantitative insulin-sensitivity check index -LSB- QUICKI -RSB- and homeostasis model of assessment-insulin resistance -LSB- HOMA-IR -RSB- ) and plasma lipid profile were assessed at @ months ( CAPITAIN ) and @ months ( PREVAIL-US ) after initiating treatment .


In CAPITAIN ( n = @ ) , no significant differences from baseline in HbA@c , insulin , HOMA-IR and QUICKI were observed at day @ in patients treated with pitavastatin .


A small ( @ % ) increase in FPG from baseline to day @ ( P < @ ) , was observed .


In the validation dataset ( n = @ ) , no significant differences from baseline in glycemic parameters were observed at day @ ( all comparisons P > @ ) .


Similar results were observed for pravastatin in the comparison dataset ( n = @ ) .


Other than a small change in FPG in the CAPITAIN study , neutral effects of pitavastatin on glucose homeostasis were observed in two cohorts of patients with metabolic syndrome , independent of its efficacy in reducing levels of atherogenic lipoproteins .


The small number of patients and relatively short follow-up period represent limitations of the study .


Nevertheless , these data suggest that statin-induced diabetogenesis may not represent a class effect .


Breastfeeding elicits significant protection against respiratory tract infections in infancy .


Modulation of respiratory microbiota might be part of the natural mechanisms of protection against respiratory diseases induced by breastfeeding .


To study the association between breastfeeding and nasopharyngeal microbial communities , including all cultivable and noncultivable bacteria .


In this observational study , we analyzed the microbiota of infants that had received exclusive breastfeeding ( n = @ ) and exclusive formula feeding ( n = @ ) at age @ weeks and @ months by @S-based GS-FLX-titanium-pyrosequencing .


At @ weeks of age the overall bacterial community composition was significantly different between breastfed and formula-fed children ( nonmetric multidimensional scaling , P = @ ) .


Breastfed children showed increased presence and abundance of the lactic acid bacterium Dolosigranulum ( relative effect size -LSB- RES -RSB- , @ ; P = @ ) and Corynebacterium ( RES , @ ; P = @ ) and decreased abundance of Staphylococcus ( RES , @ ; P @ ) and anaerobic bacteria , such as Prevotella ( RES , @ ; P < @ ) and Veillonella ( RES , @ ; P < @ ) .


Predominance ( > @ % of the microbial profile ) of Corynebacterium and Dolosigranulum was observed in @ ( @ % ) breastfed infants compared with @ ( @ % ) formula-fed infants ( relative risk , @ ; P = @ ) .


Dolosigranulum abundance was inversely associated with consecutive symptoms of wheezing and number of mild respiratory tract infections experienced .


At @ months of age associations between breastfeeding and nasopharyngeal microbiota composition had disappeared .


Our data suggest a strong association between breastfeeding and microbial community composition in the upper respiratory tract of @-week-old infants .


Observed differences in microbial community profile may contribute to the protective effect of breastfeeding on respiratory infections and wheezing in early infancy .


Clinical trial registered with www.clinicaltrials.gov ( NCT @ ) .


With spherical intraocular lens ( IOL ) implantation , unaided vision of cataract patients with pre-existing corneal astigmatism is unsatisfactory because astigmatic spectacles will always be needed for clear vision .


Toric IOL has been proven to be a major improvement in cataract surgery for spectacle independence .


Aspheric property , reported to improve visual quality in a non-toric IOL , has now been added to toric IOL for even better unaided vision .


To compare visual and aberrometric outcomes of @ toric IOL , spherical and aspheric , at @ months after implantation .


Cataract surgery was performed in cataract patients with pre-existing corneal astigmatism using @ types of toric IOLs , a spherical toric IOL , Acrys of SN@T ( Group A ) and a aspheric toric IOL , Acrts of SN@AT , ( Group B ) as a randomized control trial .


The uncorrected distance ( UDVA ) and corrected ( CDVA ) distance visual acuities , residual astigmatism , spherical equivalent ( SE ) and spherical aberration were evaluated @ months after implantation .


The present study included @ eyes .


No statistically significant difference was found in UDVA , CDVA and residual astigmatism between both groups .


The UDVA of @ logMAR or better was found in @ % in Group A and @ % in Group B.


In Group A , @ % of eyes and in Group B , @ % had a refractive astigmatism value within @ diopter at KP@ ( polar value along the @-degree meridian ) .


The spherical equivalent ( SE ) was within @ diopter of emmetropia in @ % in Group A and in @ % in Group B. Group B had significantly lower spherical aberration Z ( @ , @ ) than Group A.


Both groups had similar clinical effectiveness for unaided visual acuity , aided visual acuity and astigmatism correction .


Group B had significantly less spherical aberration induction when compared with Group A.


The GH-@ and GH-@ research groups developed a method for detecting GH misuse in athletes based on the measurement of serum IGF-I and procollagen type III amino-terminal propeptide ( P-III-NP ) .


There are reports that IGF-I is also misused by athletes , but currently there is no internationally recognized test designed to detect recombinant human IGF-I misuse .


The objective of the study was to examine the response of serum IGF-I , P-III-NP , and the GH-@ score to recombinant human ( rh ) IGF-I/rhIGF binding protein-@ ( IGFBP-@ ) administration in recreational athletes .


This was a randomized , double-blind , placebo-controlled rhIGF-I/rhIGFBP -@ administration study at Southampton General Hospital ( Southampton , United Kingdom ) .


Fifty-six recreational athletes ( @ women , @ men ) participated in the study .


Participants were randomized to treatment with low-dose ( @ mg/d ) or high-dose ( @ mg/d ) rhIGF-I/rhIGFBP -@ complex or placebo for @ days .


Blood was collected throughout the drug administration and washout periods .


Serum IGF-I and P-III-NP were measured using commercial immunoassays and GH-@ scores were calculated .


IGF-I , P-III-NP , and the GH-@ score rose in response to both low - and high-dose rhIGF-I/rhIGFBP -@ administration .


The relative maximum response of IGF-I ( approximately @-fold increase in women and men ) was greater than that of P-III-NP ( @ % -@ % increase in women , @ % -@ % increase in men ) .


The GH-@ formulae , which incorporate IGF-I and P-III-NP results , detected up to @ % of women and @ % of men in the rhIGF-I/rhIGFBP -@ groups but , using IGF-I concentrations alone , the sensitivity increased to @ % in both women and men during the administration period .


The rise in P-III-NP after rhIGF-I/rhIGFBP -@ administration is small compared with that after rhGH administration .


Although rhIGF-I/rhIGFBP -@ administration can be detected using the GH-@ score method , a test based on serum IGF-I alone provides better sensitivity .


In this corollary analysis of the EXCITE study , we looked at possible differences in baseline risk factors and mortality between subjects excluded from the trial because non-eligible ( n = @ ) or because eligible but refusing to participate ( n = @ ) .


Baseline characteristics and mortality data were recorded .


Survival and independent predictors of mortality were assessed by Kaplan-Meier and Cox regression analyses .


The incidence rate of mortality was higher in non-eligible vs. eligible non-randomized patients ( @ vs. @ deaths/@ persons-year ; P < @ ) .


The crude excess risk of death in non-eligible patients ( HR @ ; @ % CI @ to @ ; P < @ ) was reduced after adjustment for risk factors which differed in the two cohorts including age , blood pressure , phosphate , CRP , smoking , diabetes , triglycerides , cardiovascular comorbidities and history of neoplasia ( HR @ ; @ % CI @ to @ ; P = @ ) and almost nullified after including in the same model also information on deambulation impairment ( HR @ ; @ % CI @ to @ ; P = @ ) .


Deambulation ability mostly explains the difference in survival rate in non-eligible and eligible non-randomized patients in the EXCITE trial .


Extending data analyses and outcome reporting also to subjects not taking part in a trial may be helpful to assess the representability of the study population .


Nutrition can affect the hypothalamus-pituitary-adrenal axis .


We hypothesized that early administration of parenteral nutrition ( PN ) during critical illness reduces plasma ACTH and cortisol concentrations and thereby increases the use of corticosteroids .


This is a preplanned substudy of a randomized controlled trial ( EPaNIC ) that compared early PN with late PN in @ critically ill patients .


We investigated the effect of early vs late PN on any steroid treatment and on treatment for @ days to capture patients with clinical suspicion of adrenal insufficiency , and assessed whether this was related to an effect on septic shock .


Also , in a propensity score-matched subgroup ( n = @ ) of patients not receiving steroids , plasma ACTH and ( free ) cortisol were quantified .


Compared with late PN , more patients on early PN received treatment with corticosteroids ( @ % vs @ % ; P = @ ) and with corticosteroids for @ days ( @ % vs @ % ; P = @ ) .


However , plasma ACTH and ( free ) cortisol concentrations were unaffected and thus could not explain the higher use of corticosteroids with early PN .


Instead , more patients developed new septic shock with early PN ( @ % ) than with late PN ( @ % ) ( P = @ ) .


In multivariate logistic regression analysis , new septic shock was an independent determinant for @ days steroid treatment ( odds ratio , @ ; @ % confidence interval , @-@ @ ; P < @ ) , statistically explaining the effect of early PN on steroid treatment .


Early PN did not affect plasma concentrations of ACTH and ( free ) cortisol , but increased the incidence of septic shock , which statistically explained why more patients on early PN received corticosteroids .


Cyclosporin-A ( CsA ) has been reported to reduce myocardial infarct size in both the experimental and clinical settings .


This protective effect is dependent on its ability to prevent the opening of the mitochondrial permeability transition pore , a critical determinant of cell death in the setting of acute ischaemia-reperfusion injury .


Whether CsA can reduce the extent of peri-operative myocardial injury ( PMI ) in patients undergoing coronary artery bypass graft ( CABG ) surgery is unknown , and is investigated in this randomised controlled clinical trial .


@ adult patients undergoing elective CABG surgery were randomised to receive either an intravenous bolus of CsA ( @ mg/kg ) or placebo administered after induction of anaesthesia and prior to sternotomy .


PMI was assessed by measuring serum cardiac enzymes , troponin T ( cTnT ) and CK-MB at @ , @ , @ , @ , @ and @ h after surgery .


There was no significant difference in mean peak cTnT levels between control ( n = @ ) and CsA treatment ( n = @ ) patients ( @ ng/mL with control vs @ ng/mL with CsA ; p = @ ) .


However , in higher-risk patients with longer cardiopulmonary bypass times , there was a significant reduction in PMI with CsA therapy ( p = @ ) , with a reduced postoperative cTnT rise by @ ng/mL for every @ min , when compared with control .


In patients with longer cardiopulmonary bypass times , a single intravenous bolus of CsA administered prior to CABG surgery reduced the extent of PMI .


To evaluate the feasibility of implementing an interdisciplinary , multifaceted knowledge translation intervention within long-term care ( LTC ) and to identify any challenges that should be considered in designing future studies .


Cluster randomized controlled trial .


Forty LTC homes across the province of Ontario , Canada .


LTC teams composed of physicians , nurses , pharmacists , and other staff .


Cluster-level feasibility measures , including recruitment , retention , data completion , and participation in the intervention .


A process evaluation was completed by directors of care indicating which process/policy changes had been implemented .


Recruitment and retention rates were @ % and @ % , respectively .


Good fidelity with the intervention was achieved , including attendance at educational meetings .


After ViDOS , @ process indicators were being newly implemented by more than @ % of active intervention homes .


Despite recruitment and retention challenges , the multifaceted intervention produced a number of policy/process changes and had good intervention fidelity .


This study is registered at ClinicalTrials.gov NCT@ .


Midazolam has been widely studied for preventing emergence agitation .


The authors previously reported that in children with sevoflurane anesthesia , intravenous administration of midazolam ( @ mg/kg ) before the end of surgery reduced the incidence of emergence agitation but prolonged the emergence time .


This study was designed to test the hypothesis that a lower midazolam dose could suppress emergence agitation with minimal disturbance of the emergence time in children with sevoflurane anesthesia .


In this randomized , double-blind , placebo-controlled trial , @ children ( @ to @ yr of age ) having strabismus surgery were randomized to @:@:@ to receive @ mg/kg of midazolam , @ mg/kg of midazolam , or saline just before the end of surgery .


The primary outcome , the incidence of emergence agitation , was evaluated by using the pediatric anesthesia emergence delirium scale and the four-point agitation scale .


The secondary outcome was time to emergence , defined as the time from sevoflurane discontinuation to the time to extubation .


The incidence of emergence agitation was lower in patients given @ mg/kg of midazolam ( @ of @ , @ % ) and patients given @ mg/kg of midazolam ( @ of @ , @ % ) compared with that in patients given saline ( @/of @ , @ % ; P = @ each ) .


The emergence time was longer in patients given @ mg/kg of midazolam ( @ @ min , mean SD ) compared with that in patients given @ mg/kg of midazolam ( @ @ min ; P = @ ) or saline ( @ @ min ; P = @ ) .


Intravenous administration of @ mg/kg of midazolam just before the end of surgery reduces emergence agitation without delaying the emergence time in children having strabismus surgery with sevoflurane anesthesia .


Non-invasive ventilation is part of the standard of care for treatment of respiratory failure in patients with amyotrophic lateral sclerosis ( ALS ) .


The NeuRx RA/@ Diaphragm Pacing System has received Humanitarian Device Exemption approval from the US Food and Drug Administration for treatment of respiratory failure in patients with ALS .


We aimed to establish the safety and efficacy of diaphragm pacing with this system in patients with respiratory muscle weakness due to ALS .


We undertook a multicentre , open-label , randomised controlled trial at seven specialist ALS and respiratory centres in the UK .


Eligible participants were aged @ years or older with laboratory supported probable , clinically probable , or clinically definite ALS ; stable riluzole treatment for at least @ days ; and respiratory insufficiency .


We randomly assigned participants ( @:@ ) , via a centralised web-based randomisation system with minimisation that balanced patients for age , sex , forced vital capacity , and bulbar function , to receive either non-invasive ventilation plus pacing with the NeuRx RA/@ Diaphragm Pacing System or non-invasive ventilation alone .


Patients , carers , and outcome assessors were not masked to treatment allocation .


The primary outcome was overall survival , defined as the time from randomisation to death from any cause .


Analysis was by intention to treat .


This trial is registered , ISRCTN number @ .


Between Dec @ , @ , and Dec @ , @ , we randomly assigned @ participants to receive either non-invasive ventilation alone ( n = @ ) or non-invasive ventilation plus diaphragm pacing ( n = @ ) .


On Dec @ , @ , the Data Monitoring and Ethics Committee ( DMEC ) recommended suspension of recruitment on the basis of overall survival figures .


Randomly assigned participants continued as per the study protocol until June @ , @ , when the DMEC advised discontinuation of pacing in all patients .


Follow-up assessments continued until the planned end of the study in December , @ .


Survival was shorter in the non-invasive ventilation plus pacing group than in the non-invasive ventilation alone group ( median @ months -LSB- @ % CI @-@ -RSB- vs @ months -LSB- @-not reached -RSB- ; adjusted hazard ratio @ , @ % CI @-@ ; p = @ ) .


@ ( @ % ) patients died in the pacing group and @ ( @ % ) patients died in the non-invasive ventilation alone group .


We recorded @ adverse events ( @ events per person-year ) in the pacing group , of which @ events were serious , compared with @ events ( @ events per person-year ) in the non-invasive ventilation alone group , of which @ events were serious .


Addition of diaphragm pacing to standard care with non-invasive ventilation was associated with decreased survival in patients with ALS .


Our results suggest that diaphragmatic pacing should not be used as a routine treatment for patients with ALS in respiratory failure .


Our study assessed the effectiveness of Interpersonal Psychotherapy ( IPT ) tailored for biomedical patients with depression and pain .


IPT was compared to enhanced treatment as usual ( E-TAU ) among women with co-occurring depression and chronic pain presenting for care at a women 's health or family medicine practice .


We hypothesized that women presenting to urban medical practices with depression and chronic pain would benefit from IPT tailored to address their needs to a greater degree than from E-TAU .


We conducted a randomized controlled psychotherapy trial of @ women from @ urban medical practices who met criteria for major depressive disorder and chronic pelvic pain .


Participants were assigned to receive either @ sessions of IPT or a facilitated psychotherapy referral to a community mental health center , and assessed for depression , social interactions , and pain at @ - , @ - , @ - , and @-weeks , with score on the Hamilton Rating Scale for Depression as the primary outcome .


Both intent-to-treat ( ITT ) and causal modeling analyses correcting for treatment attendance were conducted .


ITT analyses were not significant .


In causal modeling analyses , participants assigned to IPT showed significantly more improvement for depression and social interactions , but not for pain .


IPT may be a viable option as part of a comprehensive treatment program for women in medical practices with depression and chronic pain .


Local transdermal therapy to the breast may achieve effective target-organ drug delivery , while diminishing systemic effects .


We conducted a randomized , double-blind , placebo-controlled phase II trial comparing transdermal @-hydroxytamoxifen gel ( @-OHT ) to oral tamoxifen ( oral-T ) in women with ductal carcinoma in situ ( DCIS ) .


Twenty-seven pre - and postmenopausal women were randomized to @-OHT ( @ mg/day ) or oral-T ( @ mg/day ) for @ to @ weeks before surgery .


Plasma , nipple aspirate fluid , and breast adipose tissue concentrations of tamoxifen and its major metabolites were determined by liquid chromatography/tandem mass spectrometry .


The primary endpoint was Ki@ labeling in DCIS lesions , measured by immunohistochemistry .


In plasma , insulin-like growth factor-@ ( IGFI ) , sex hormone-binding globulin ( SHBG ) , and coagulation protein concentrations were determined .


Posttherapy Ki@ decreased by @ % in the @-OHT and @ % in the oral-T group ( P @ in both , between-group P = @ ) .


Mean plasma @-OHT was @ and @ ng/mL in @-OHT and oral groups , respectively ( P = @ ) , whereas mean breast adipose tissue concentrations of @-OHT were @ ng/g in the @-OHT group and @ ng/g in the oral group ( P = @ ) .


There were significant increases in plasma SHBG , factor VIII , and von Willebrand factor and a significant decrease in plasma IGFI with oral-T , but not with @-OHT .


The incidence of hot flashes was similar in both groups .


The antiproliferative effect of @-OHT gel applied to breast skin was similar to that of oral-T , but effects on endocrine and coagulation parameters were reduced .


These findings support the further evaluation of local transdermal therapy for DCIS and breast cancer prevention .


There is a considerable body of evidence supporting the effectiveness of personalized feedback interventions for hazardous alcohol use-whether delivered face-to-face , by postal mail , or over the Internet ( probably now the primary mode of delivery ) .


The Check Your Drinking Screener ( CYD ; see www.CheckYourDrinking.net ) is one such intervention .


The current treatment dismantling study assessed which components of personalized feedback interventions were effective in motivating change in drinking .


Specifically , the major objective of this project was to conduct a randomized controlled trial ( RCT ) comparing the impact of the normative feedback and other personalized feedback components of the CYD intervention in the general population .


Participants were recruited to take part in an RCT and received either the complete CYD final report , just the normative feedback sections of the CYD , just the personalized feedback components of the CYD , or were assigned to a no-intervention control group .


Participants were followed-up at @ months to assess changes in alcohol consumption .


A total of @ hazardous drinking participants were recruited for the trial , of which @ percent provided follow-up data .


Analyses using an intent-to-treat approach found some evidence for the impact of the personalized feedback components of the CYD in reducing alcohol consumption on the variables , number of drinks in a week and AUDIT-C ( p = @ and @ respectively ; no impact on highest number of drinks on one occasion ; p = @ ) .


However , there was no significant evidence of the impact of the normative feedback components ( all p > @ ) .


Personalized feedback elements alone could provide an active intervention for hazardous drinkers , particularly in situations where normative feedback information was not available .


Myopia is a significant public health problem , making it important to determine whether a bifocal spectacle treatment involving near prism slows myopia progression in children .


To determine whether bifocal and prismatic bifocal spectacles control myopia in children with high rates of myopia progression and to assess whether the treatment effect is dependent on the lag of accommodation and/or near phoria status .


This @-year randomized clinical trial was conducted in a private practice .


A total of @ ( @ female and @ male ) Chinese-Canadian children ( aged @-@ years ; mean -LSB- SE -RSB- age , @ -LSB- @ -RSB- years ; mean -LSB- SE -RSB- myopia , -@ -LSB- @ -RSB- D ) with myopia progression of at least @ D in the preceding year were randomly assigned to @ of @ treatments .


A total of @ ( @ % ) completed the trial .


Single-vision lenses ( control , n = @ ) , +@ - D executive bifocals ( n = @ ) , and +@ - D executive bifocals with @ - base-in prism in the near segment of each lens ( n = @ ) .


MAIN OUTCOMES AND MEASURES Myopia progression ( primary ) measured using an automated refractor following cycloplegia and increase in axial length ( secondary ) measured using ultrasonography at intervals of @ months for @ months .


RESULTS Myopia progression over @ years was an average ( SE ) of -@ ( @ ) D for the single-vision lens group , -@ ( @ ) D for the bifocal group , and -@ ( @ ) D for the prismatic bifocal group .


Axial length increased an average ( SE ) of @ ( @ ) mm , @ ( @ ) mm , and @ ( @ ) mm , respectively .


The treatment effect of bifocals ( @ D ) and prismatic bifocals ( @ D ) was significant ( P < @ ) .


Both bifocal groups had less axial elongation ( @ mm and @ mm , respectively ) than the single-vision lens group ( P < @ ) .


For children with high lags of accommodation ( @ D ) , the treatment effect of both bifocals and prismatic bifocals was similar ( @ D ) ( P < @ ) .


For children with low lags ( < @ D ) , the treatment effect of prismatic bifocals ( @ D ) was greater than of bifocals ( @ D ) ( P = @ ) .


The treatment effect of both bifocals and prismatic bifocals was independent of the near phoria status .


Bifocal spectacles can slow myopia progression in children with an annual progression rate of at least @ D after @ years .


These results suggest that prismatic bifocals are more effective for myopic children with low lags of accommodation .


TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT@ .


To observe the clinical efficacy and safety of sildenafil in the treatment of high altitude heart disease associated with severe pulmonary arterial hypertension ( PAH ) in children .


Fifty children ( aged @ months to @ years ) with high altitude heart disease associated with severe PAH , who were continuously transferred to the Intensive Care Unit between January @ and October @ , were randomly assigned to observation and control groups .


The control group was given conventional treatment , while the observation group received oral sildenafil -LSB- @ mg / ( kg.d ) -RSB- three times daily for @-@ days in addition to the conventional treatment .


Before and after treatment , hemodynamics , blood gas , routine blood parameters , and blood biochemical parameters were recorded .


After treatment , the observation group had a significantly higher decrease in mean pulmonary artery pressure and significantly higher increases in arterial partial pressure of oxygen , cardiac output , cardiac index , and oxygenation index compared with the control group ( P < @ ) .


In the observation group , there were no significant changes in mean arterial pressure , routine blood parameters and blood biochemical parameters ( P > @ ) , and no obvious adverse reactions were found .


For children with high altitude heart disease associated with severe PAH , sildenafil can effectively reduce pulmonary artery pressure and improve cardiac function and does not cause adverse reactions .


This therapy has good safety according to the preliminary evaluation .


Surgical plethysmographic index ( SPI ) has been proposed as a tool to measure the nociception/antinociception balance during general anaesthesia .


Untreated nociception may increase sympathetic tone , but the relationship between SPI and the autonomic nervous system ( ANS ) is poorly understood .


We hypothesised that two different levels of SPI might be associated with differences in ANS modulation , measured by the frequency domain analysis of heart rate variability ( HRV ) .


A randomised , cross-over group study , conducted between February and November @ .


University tertiary referral hospital in Milan , Italy .


Forty-two adult patients undergoing scheduled laparoscopic abdominal surgery .


ECG , noninvasive arterial blood pressure and SPI were recorded during balanced general anaesthesia with inhaled sevoflurane and intravenous remifentanil .