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 NCT01530243 .


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 .


100 adult , ASA physical status 1 , 2 , and 3 patients undergoing ambulatory surgery .


Patients were administered fentanyl 1 g/kg ( n = 51 ) or saline ( n = 49 ) 3 to 5 minutes before induction with propofol 2-2 .5 mg/kg intravenously ( IV ) , followed by LMA placement .


Anesthesia was maintained with desflurane titrated to a bispectral index ( BIS ) of 50-60 and 50 % nitrous oxide in oxygen , and fentanyl 25 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 ( 94 % vs 64 % ; P = 0.0003 ) and longer duration of manual ventilation ( 3 [ interquartile range ( IQR ) , 1.5-5 ] min vs 1 [ 0-1 .5 ] min ; P < 0.0001 ) at induction .


In contrast , the fentanyl pretreatment group had a lower frequency of movements ( 16 % vs 51 % ;P = 0.0001 ) .


The rates of intraoperative breath holding ( 6.1 % vs 8.5 % ) and laryngospasm ( 2 % vs 4.3 % ) 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 = 0.043 ) .


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 22 factorial randomized , blinded , clinical trial of 6905 patients undergoing noncardiac surgery from 88 centers in 22 countries with consecutive patients enrolled between January 2011 and December 2013 .


Patients were assigned to take aspirin ( 200 mg ) or placebo 2 to 4 hours before surgery and then aspirin ( 100 mg ) or placebo daily up to 30 days after surgery , and were assigned to take oral clonidine ( 0.2 mg ) or placebo 2 to 4 hours before surgery , and then a transdermal clonidine patch ( which provided clonidine at 0.2 mg/d ) or placebo patch that remained until 72 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 0.3 mg/dL or greater ( 26.5 mol/L ) within 48 hours of surgery or an increase of 50 % or greater within 7 days of surgery .


Aspirin ( n = 3443 ) vs placebo ( n = 3462 ) did not alter the risk of acute kidney injury ( 13.4 % vs 12.3 % , respectively ; adjusted relative risk , 1.10 ; 95 % CI , 0.96-1 .25 ) .


Clonidine ( n = 3453 ) vs placebo ( n = 3452 ) did not alter the risk of acute kidney injury ( 13.0 % vs 12.7 % , respectively ; adjusted relative risk , 1.03 ; 95 % CI , 0.90-1 .18 ) .


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 ( 23.3 % when bleeding was present vs 12.3 % when bleeding was absent ; adjusted hazard ratio , 2.20 ; 95 % CI , 1.72-2 .83 ) .


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 ( 14.3 % when hypotension was present vs 11.8 % when hypotension was absent ; adjusted hazard ratio , 1.34 ; 95 % CI , 1.14-1 .58 ) .


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


clinicaltrials.gov Identifier : NCT01082874 .


To study the effect of Yinxieling decoction on PASI , TNF - and IL-8 in patients with psoriasis vulgaris .


A total of 120 cases of psoriasis vulgaris were divided into 4 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 = 30 per group ) .


Patients in observation groups were treated with Yinxieling decoction , while patients in control group were treated by placebo for 8 weeks .


Levels of TNF - and IL-8 were determined before treatment , 4 and 8 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-8 were significantly decreased in all groups .


The decrease in three observation groups was more significant ( P < 0.05 or P < 0.01 ) , and the decrease in wind heat syndrome group was the most significant ( P < 0.01 ) .


psoriasis area and severity index was positively correlated with TNF - and IL-8 , respectively ( P < 0.05 ) .


Yinxieling decoction has therapeutical effect on psoriasis vulgaris via regulating TNF - and IL-8 .


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 900 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 32.2 4.4 years and infertility duration was 34.7 25.7 months , with 59 % primary infertility .


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


The mean body mass index ( BMI ) was 27 and mean antimllerian hormone level was 2.6 ; only 11 women ( 1.3 % ) had antral follicle counts of < 5 .


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 .


NCT 01044862 .


To evaluate the efficacy and safety of AM-111 , 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 3 , 7 , 30 , and 90 .


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


Approximately 210 patients aged 18 to 61 years presenting within 48 hours after acute acoustic trauma or idiopathic sudden sensorineural hearing loss with mean hearing loss of 30 dB or greater at the 3 most affected contiguous test frequencies .


Single-dose intratympanic injection of AM-111 ( 0.4 or 2.0 mg/ml ) or placebo ; optionally , oral prednisolone if hearing improvement was less than 10 dB at Day 7 .


Efficacy was assessed by absolute hearing improvement ( primary end point , Day 7 ) , 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 60 dB ) , AM-111 0.4 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-111 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 48-week virological efficacy of atazanavir/ritonavir ( ATV/r ) monotherapy vs. ATV/r along with two nucleoside reverse transcriptase ( NRTIs ) in HIV-1 treated individuals with HIV-RNA less than 50copies/ml .


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


HIV-1 treated individuals on ATV/r 300/100mg 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 > 50copies/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 50copies/ml after 12 weeks since reintensification .


One hundred and three patients enrolled .


By week 48 , 11 patients in ATV/r arm and two in ATV/r along with two NRTIs experienced CVR ; four ( 8 % ) patients in ATV/r and eight ( 15 % ) in ATV/r along with two NRTIs discontinued .


At the 48-week primary efficacy analysis ( re-intensification = failure ) , treatment success was 73 % in ATV/r arm and 85 % in ATV/r along with two NRTIs [ difference -12.1 % , 95 % confidence interval ( 95 % CI ) -27.8 to 2.1 ] .


According to the analysis considering re-intensification is equal to success , treatment success was 92 % in ATV/r arm and 85 % in the ATV/r along with two NRTIs arm ( difference 7.5 % , 95 % CI -4.7 to 19.8 ) .


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


Overall , Grade 3-4 ( P = 0.003 ) and grade 3-4 drug-related ( P = 0.027 ) 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 34 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 30 mg/day aqueous saffron extract orally ( 17 subjects , 17 eyes ) or placebo ( 17 subjects , 17 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 12.9 3.7 versus 14.0 2.5 mmHg in the saffron and control groups , respectively ( p = 0.31 ) .


After three weeks of treatment , IOP was significantly decreased to 10.9 3.3 mmHg in the saffron group as compared to 13.5 2.3 mmHg in the control group ( p = 0.013 ) .


At four weeks , IOP was still significantly lower in the saffron group ( 10.6 3.0 versus 13.8 2.2 mmHg , p = 0.001 ) .


At the end of the wash-out period , IOP was 12.9 3.0 in the saffron group versus 14.2 2.0 mmHg in the control group ( p = 0.175 ) .


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 IRCT201201278832N1 .


To compare standard-of-care grid laser photocoagulation versus intravitreal ranibizumab ( IVR ) versus a combination of both in the treatment of chronic ( > 3 months ) macular oedema secondary to branch retinal vein occlusion .


Prospective , randomized , multicentre clinical trial .


Thirty patients with a best-corrected visual acuity ( BCVA ) between 20/320 and 20/40 were randomized 1:1:1 to receive grid laser or three monthly injections of 0.5 mg IVR or both followed by 3 months of observation .


Mean change from baseline BCVA at month 6 was +2 letters [ laser ; 0.04 logMAR , 95 % confidence interval ( -0.17 ; 0.25 ) ] , +17 letters [ IVR ; 0.34 ( 0.19 ; 0.5 ) ] and +6 letters [ combination ; 0.12 ( 0.01 ; 0.24 ) ] ( IVR versus laser p = 0.02 and IVR versus combination p = 0.02 ) .


At month 3 , mean improvement in central retinal thickness ( CRT ) was 90.6 m ( laser ) ( -18.65 ; 199.8 ) , 379.5 m ( IVR ) ( 204.2 ; -554.8 ) , and 248 m ( 167.2 ; -328.8 ) ( combination ) ( IVR versus laser p = 0.005 , laser versus combination p = 0.02 ) .


During the observation period , CRT improved in laser [ 37.6 m ( -66.82 ; 142.0 ) ] , but deteriorated in IVR [ -142.4 m ( -247.6 ; -37.16 ) ] and combination [ -171.7 m ( -250.4 ; -92.96 ) ] ( laser versus IVR p = 0.01 , laser versus combination p = 0.002 ) indicating recurrent oedema .


Less laser retreatments ( at 8 weeks ) were required in combination group ( 2/10 ) than grid group ( 7/10 ) .


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 2 diabetes patients .


To compare the impact of moderate versus mild aerobic exercise training on the inflammatory cytokines in obese type 2 diabetic patients .


Fifty obese type 2 diabetic patients of both sexes with body mass index ( BMI ) varying from 31 to 36 kg/m ( 2 ) , non smokers , free from respiratory , kidney , liver , metabolic and neurological disorders , participated in this study .


Their age ranged from 40 to 55 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 3 months .


The mean values of leptin , TNF - alpha , IL2 , IL4 , IL6 , HOMA-IR and HBA1c 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 2 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 86 male patients scheduled for elective unilateral inguinal hernia repair with either ultrasound-guided IFB ( n = 42 ) or SAB ( n = 44 ) .


Dynamic and static pain at 4 hours ( P < .01 , r > 0.34 , `` large effect size '' ) , and dynamic pain the morning after operation ( P = .04 , r > 0.20 , `` medium effect size '' ) were less in the field block group compared with the SAB group .


Postoperative analgesic consumption was reduced during hospital stay ( P = .005 , r > 0.34 , `` large effect size '' ) and for 7 postoperative days in the field block group ( P = .03 , r > 0.20 , `` 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 1 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 84years ) with low physical performance ( mean SPPB score 3.7 ) participated in this blinded , randomized controlled pilot trial .


The intervention was either a 10week , 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 12Hz frequency was well tolerated with mean 95 % compliance in contrast to higher 18Hz ( or 26Hz ) frequency , which was poorly ( < 30 % ) tolerated .


While treatment effects were not significant , the mean change in SPPB score was 0.4 ( range from -2 to +4 ) in the WBV group in contrast to -0.1 ( from -3 to +3 ) 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 12Hz 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 10.8 2.1 y , were enrolled in a randomized , double-blind , placebo-controlled cross-over study .


After a 4-wk diet run-in period , the children received probiotics ( B. animalis subspecies lactis MB 2409 , B. bifidum MB 109B , and B. longum subspecies longum BL04 ) or placebo for 3 mo. .


After 1 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 ) 222.8 23.2 mg/dL , high-density lipoprotein cholesterol ( HDL-C ) 55.8 12.2 mg/dL , triglycerides ( TG ) 99.0 61.7 mg/dL , and low-density lipoprotein cholesterol ( LDL-C ) 147.2 21.9 mg/dL .


After 3 mo of probiotic treatment , the lipid profile was : TC 211.9 27.3 mg/dL , HDL-C 60.7 14.2 mg/dL , TG 79.5 34.5 mg/dL , and LDL-C 135.3 24.2 mg/dL .


Compared with placebo , probiotics reduced TC by 3.4 % ( P = 0.02 ) and LDL-C by 3.8 % ( P = 0.001 ) .


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 6-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 6 weeks ( n = 155 ) were compared to those who were not ( n = 193 ) .


Participants reported smoking 20 cigarettes daily at baseline and received smoking cessation counseling , 21 mg nicotine patch daily , and either placebo or 1 of 3 doses of naltrexone ( 25 , 50 , or 100mg ) for 6 weeks .


Change in indirect and total bilirubin following the quit date was measured at Weeks 1 , 4 , and 6 compared to baseline .


Individuals who were continuously abstinent from smoking , independent of naltrexone condition , showed a significantly greater mean increase in indirect ( ~ unconjugated ) bilirubin ( 0.06 mg/dl , SD = 0.165 ) compared to those who did not ( mean = 0.02 , SD = 0.148 , p = .015 ) .


Similar results were obtained for total bilirubin ( p = .037 ) .


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 32 patients ( 19 men and 13 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 ( 0.125 % levobupivacaine or 0.2 % ropivacaine , 15 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 15 , 30 , 60 , and 90 minutes after epidural block , respectively .


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


There were no significant differences ( P < 0.05 ) in the upper level of analgesia , VAS , and Bromage scale between 0.125 % levobupivacaine and 0.2 % ropivacaine throughout the time course .


There were no significant differences in the recovery times to mobilization , ambulation , and spontaneous micturition between 0.125 % levobupivacaine and 0.2 % ropivacaine .


There were no significant differences in arterial blood pressure and heart rate between the 2 trials throughout the time course .


The results showed that 0.125 % levobupivacaine and 0.2 % 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 4weeks 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 2 diabetes mellitus at high risk of stroke .


A prospective , multicenter , randomized , open label , comparative study was conducted among diabetic patients recruited from 50 medical institutions nationwide .


A total of 522 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 = 254 ) or without pioglitazone ( n = 268 ) and observed for a medium of 672 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 HbA1c , 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 10 patients in the non-pioglitazone group .


The difference in the cumulative incidence of the primary outcome was not significant between the two groups ( 1.8 % 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 18 years or older were randomly selected to receive either 600 mg ALA or a placebo three times a day orally for 24 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 243 ( 29 % ) patients completed the study ( 24 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 1134 consecutive patients underwent a first catheter ablation procedure of PAF between June 2008 and December 2012 .


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


In 68 patients ( 6 % ) , AF sustained after successful PVI .


These patients were randomized to either cardioversion ( PVI-alone group ; n = 33 ) or additional CFAE ablation ( PVI+CFAE group ; n = 35 ) and followed up every 1-3 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 3 months .


Procedure duration ( 127 6 minutes vs 174 10 minutes ) , radiofrequency application time ( 44 3 minutes vs 74 5 minutes ) , and fluoroscopy time ( 26 2 minutes vs 41 3 minutes ) were longer in the PVI+CFAE group ( all P < .001 ) .


In 30 of 35 patients ( 86 % ) in the PVI+CFAE group , ablation terminated AF .


There was no significant group difference with respect to freedom from AF/AT ( 22 of 33 [ 67 % ] vs 22 of 35 [ 63 % ] ; P = .66 ) .


Subsequently , 10 of 11 patients in the PVI-alone group ( 91 % ) and 11 of 13 patients in PVI+CFAE group ( 85 % ) underwent repeat ablation ( P = 1.00 ) .


Overall , 29 of 33 [ 88 % ] vs 30 of 35 [ 86 % ] patients ( P = 1.00 ) were free from AF/AT after 1.4 0.1 vs 1.4 0.2 ( P = .87 ) 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 4 days afterwards .


Owners completed a diary of adverse events following treatment .


Adverse events occurred in 40/58 ( 69 % ) dogs in the vincristine group .


Most of these adverse events were mild and included : lethargy ( 62 % ) , appetite loss ( 43 % ) , diarrhoea ( 34 % ) and vomiting ( 24 % ) .


Adverse events occurred in 34/42 ( 81 % ) dogs treated with cyclophosphamide .


Most of these adverse events were mild and included : lethargy ( 62 % ) , diarrhoea ( 36 % ) , appetite loss ( 36 % ) and vomiting ( 21 % ) .


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 0247 , primary endpoint analysis of which demonstrated that preoperative radiation therapy ( RT ) with capecitabine plus oxaliplatin achieved a pathologic complete remission prespecified threshold ( 21 % ) to merit further study , whereas RT with capecitabine plus irinotecan did not ( 10 % ) .


A randomized , phase 2 trial evaluated preoperative RT ( 50.4 Gy in 1.8-Gy fractions ) with 2 concurrent chemotherapy regimens : ( 1 ) capecitabine ( 1200 mg/m ( 2 ) / d Monday-Friday ) plus irinotecan ( 50 mg/m ( 2 ) / wk 4 ) ; and ( 2 ) capecitabine ( 1650 mg/m ( 2 ) / d Monday-Friday ) plus oxaliplatin ( 50 mg/m ( 2 ) / wk 5 ) for clinical T3 or T4 rectal cancer .


Surgery was performed 4 to 8 weeks after chemoradiation , then 4 to 6 weeks later , adjuvant chemotherapy ( oxaliplatin 85 mg/m ( 2 ) ; leucovorin 400 mg/m ( 2 ) ; 5-fluorouracil 400 mg/m ( 2 ) ; 5-fluorouracil 2400 mg/m ( 2 ) ) every 2 weeks 9 .


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 104 patients ( median age , 57 years ) were treated ; characteristics were similar for both arms .


Median follow-up for RT with capecitabine/irinotecan arm was 3.77 years and for RT with capecitabine/oxaliplatin arm was 3.97 years .


Four-year DFS , OS , LRF , DF , and SP estimates for capecitabine/irinotecan arm were 68 % , 85 % , 16 % , 24 % , and 2 % , respectively .


The 4-year DFS , OS , LRF , DF , and SP failure estimates for capecitabine/oxaliplatin arm were 62 % , 75 % , 18 % , 30 % , and 6 % , 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 65 years ) were randomized equally into 4 groups including a control group without dexmedetomidine and 3 dexmedetomidine groups ( groups D1 , D2 , and D3 ) with loading dexmedetomidine doses of 0.2 , 0.5 , and 0.8 g/kg and maintenance doses of 0.2 , 0.5 , and 0.8 gkg ( -1 ) h ( -1 ) , respectively .


Dex was discontinued 30 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 1 day before and at 1 day and 3 days after the operation .


The incidence of postoperative cognitive dysfunction ( POCD ) was significantly lower in groups D2 and D3 than in the control group and group D1 ( P < 0.05 ) .


The incidences of hypotension and bradycardia were the highest in group D3 ( P < 0.05 ) , which also had longer significantly TO and TE than the other 3 groups ( P < 0.05 ) .


Dexmedetomidine with a loading dose of 0.5 g/kg followed by maintenance doses of 0.5 and 0.8 gkg ( -1 ) h ( -1 ) ( preferentially 0.5 gkg ( -1 ) h ( -1 ) ) 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 126 patients using both the single wall and vessel transfixing technique in random order .


The primary outcome was successful cannulation of the radial artery in 4 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 88 % and 86 % of patients using the transfixing technique and single wall group , respectively ( difference 2 % ; 95 % CI , 14-9 , P = 0.8 , Fisher exact test ) .


Cannulation was successfully on the first attempt in 38 % of the transfixing compared to 54 % using the single wall technique ( difference -- 16 % ; 95 % CI , 32-2 , P = 0.1 , Fisher Exact test ) .


The median ( interquartile range ) time to successful cannulation was longer in the transfixing group , 105 ( 69-176 ) seconds compared to 65 ( 25-114 ) seconds in the single puncture group ( P = .009 , 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 8-20 , supratentorial ischemic stroke , and 24-48h 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 , 4000-20 ,000 IU/dose ) vs. placebo .


Primary outcomes were safety and neurological recovery .


The study was halted early by the sponsor after 96 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 90 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 = 14 264 ) 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 14 062 patients , 11 548 ( 82 % ) had persistent AF and 2514 ( 18 % ) had paroxysmal AF .


Patients with persistent AF were marginally older ( 73 vs. 72 , P = 0.03 ) , less likely female ( 39 vs. 45 % , P < 0.0001 ) , and more likely to have previously used vitamin K antagonists ( 64 vs. 56 % , P < 0.0001 ) compared with patients with paroxysmal AF .


In patients randomized to warfarin , time in therapeutic range was similar ( 58 vs. 57 % , P = 0.94 ) .


Patients with persistent AF had higher adjusted rates of stroke or systemic embolism ( 2.18 vs. 1.73 events per 100-patient-years , P = 0.048 ) and all-cause mortality ( 4.78 vs. 3.52 , P = 0.006 ) .


Rates of major bleeding were similar ( 3.55 vs. 3.31 , P = 0.77 ) .


Rates of stroke or systemic embolism in both types of AF did not differ by treatment assignment ( rivaroxaban vs. warfarin , Pinteraction = 0.6 ) .


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 3-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 .


May 2014 - ClinicalTrials.gov : NCT02158871 .


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 950 unconscious adults after out-of-hospital cardiac arrest of presumed cardiac cause to targeted temperature management at either 33C or 36C .


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 180 days , as evaluated with the Cerebral Performance Category ( CPC ) scale and the modified Rankin scale .


In total , 939 patients were included in the primary analysis .


At the end of the trial , 50 % of the patients in the 33C group ( 235 of 473 patients ) had died , as compared with 48 % of the patients in the 36C group ( 225 of 466 patients ) ( hazard ratio with a temperature of 33C , 1.06 ; 95 % confidence interval [ CI ] , 0.89 to 1.28 ; P = 0.51 ) .


At the 180-day follow-up , 54 % of the patients in the 33C group had died or had poor neurologic function according to the CPC , as compared with 52 % of patients in the 36C group ( risk ratio , 1.02 ; 95 % CI , 0.88 to 1.16 ; P = 0.78 ) .


In the analysis using the modified Rankin scale , the comparable rate was 52 % in both groups ( risk ratio , 1.01 ; 95 % CI , 0.89 to 1.14 ; P = 0.87 ) .


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 33C did not confer a benefit as compared with a targeted temperature of 36C .


( Funded by the Swedish Heart-Lung Foundation and others ; TTM ClinicalTrials.gov number , NCT01020916 . )


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 , 257 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 ( Y90 ) compared to Y90 alone in patients awaiting liver transplantation .


20 patients with HCC were randomized to Y90 alone ( Group A ) or Y90 + sorafenib ( Group B ) .


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


All patients in the sorafenib group necessitated dose reductions .


Seventeen of 20 patients underwent liver transplantation ; median time-to-transplant was 7.8 months ( range : 4.2-20 .3 ) and similar between groups ( p = 0.35 ) .


In the sorafenib group , there were 4/8 peri-transplant ( < 30 days ) biliary complications ( p = 0.029 ) and 3/8 acute rejections ( p = 0.082 ) ; there were none in the Y90-only group .


Survival rates were 70 % ( Group A ) and 72 % ( Group B ) at 3 years ( p = 0.57 ) .


The addition of sorafenib to Y90 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 31-A2 .2 or A2 .3 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 12months 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-5D ( EQ-5D ) scores than the AMBI group at 12months .


At the same time , the EQ-5D 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 31-A2 .2 and A2 .3 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 [ PRWHE ] and Disabilities of the Arm , Shoulder and Hand [ DASH ] 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 ( 71 % versus 29 % ; p = 0.016 ) , 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 ( 86 % ) than in the arthrodesis group ( 53 % ) indicated they would consider the same surgery again under the same circumstances ( p = 0.025 ) .


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 < 31 ng/dL and/or free T < 3.5 pg/mL received a standardized transdermal estradiol regimen during the 12-week run-in period and were then randomized to receive weekly im injections of placebo or 3 , 6.25 , 12.5 , or 25 mg T enanthate for 24 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 24 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 13 , 83 , 106 , 122 , and 250 ng/dL in the placebo , 3 - , 6.25 - , 12.5 - , and 25-mg groups , respectively .


Analyses of acoustic voice parameters revealed significant lowering of average pitch in the 12.5 - and 25-mg dose groups compared to placebo ( P < .05 ) ; 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 24 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 15 hospitals during March 2011 to July 2012 .


A total of 1489 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 10 % regarded as the superiority .


Totally 1458 children completed the study , in whom 726 children received ER XIE TING GRANULES and 732 received smectite powder .


After three-day and seven-day therapy , cure rates and total efficacy rates of the treatment group were 44.2 % , 94.1 % , 88.8 % , and 97.9 % separately and higher than those of control group ( 39.3 % , 88.4 % , 83.9 % , 97.4 % ) ( Z = 3.2 , P < 0.01 ; Z = 2.46 , P < 0.05 ) .


There were 520 children with rotavirus infection and in whom 266 cases received ER XIE TING GRANULES and 254 received smectite powder .


For rotavirus enteritis , cure rates and total efficacy rates of the treatment group after three-day and seven-day therapy were 40.6 % , 95.1 % , 89.9 % , and 98.9 % separately and higher than those of control group ( 26.4 % , 84.3 % , 78.8 % , and 96.8 % ) ( Z = 4.807 , P < 0.01 ; Z = 3.519 , P < 0.01 ) .


The lower limits of the 95 % confidence interval of difference of cure rate and total efficacy rates after three-day and seven-day therapy between two groups were less than 10 % .


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 100 mg nitrofurantoin or placebo once daily during catheterization if they were : 1 ) discharged with a transurethral Foley or performing intermittent self-catheterization ; or 2 ) hospitalized overnight with a transurethral Foley .


Our primary outcome was treatment for clinically suspected or culture-proven UTI within 3 weeks of surgery .


Statistical analysis was performed by 2 and logistic regression .


Assuming 80 % power at a P value of .05 , 156 participants were needed to demonstrate a two-thirds reduction in UTI .


Of 159 participants , 81 ( 51 % ) received nitrofurantoin and 78 ( 49 % ) 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 3 weeks of surgery ( 22 % UTI with nitrofurantoin compared with 13 % UTI with placebo , relative risk 1.73 , 95 % confidence interval 0.85-3 .52 , P = .12 ) .


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 .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT01450800 .


I.


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 4mg/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 [ FPG ] , glycated hemoglobin [ HbA1c ] , insulin , quantitative insulin-sensitivity check index [ QUICKI ] and homeostasis model of assessment-insulin resistance [ HOMA-IR ] ) and plasma lipid profile were assessed at 6 months ( CAPITAIN ) and 3 months ( PREVAIL-US ) after initiating treatment .


In CAPITAIN ( n = 12 ) , no significant differences from baseline in HbA1c , insulin , HOMA-IR and QUICKI were observed at day 180 in patients treated with pitavastatin .


A small ( 4 % ) increase in FPG from baseline to day 180 ( P < 0.05 ) , was observed .


In the validation dataset ( n = 9 ) , no significant differences from baseline in glycemic parameters were observed at day 84 ( all comparisons P > 0.05 ) .


Similar results were observed for pravastatin in the comparison dataset ( n = 14 ) .


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 = 101 ) and exclusive formula feeding ( n = 101 ) at age 6 weeks and 6 months by 16S-based GS-FLX-titanium-pyrosequencing .


At 6 weeks of age the overall bacterial community composition was significantly different between breastfed and formula-fed children ( nonmetric multidimensional scaling , P = 0.001 ) .


Breastfed children showed increased presence and abundance of the lactic acid bacterium Dolosigranulum ( relative effect size [ RES ] , 2.61 ; P = 0.005 ) and Corynebacterium ( RES , 1.98 ; P = 0.039 ) and decreased abundance of Staphylococcus ( RES , 0.48 ; P 0.03 ) and anaerobic bacteria , such as Prevotella ( RES , 0.25 ; P < 0.001 ) and Veillonella ( RES , 0.33 ; P < 0.001 ) .


Predominance ( > 50 % of the microbial profile ) of Corynebacterium and Dolosigranulum was observed in 45 ( 44.6 % ) breastfed infants compared with 19 ( 18.8 % ) formula-fed infants ( relative risk , 2.37 ; P = 0.006 ) .


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


At 6 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 6-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 00189020 ) .


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 2 toric IOL , spherical and aspheric , at 3 months after implantation .


Cataract surgery was performed in cataract patients with pre-existing corneal astigmatism using 2 types of toric IOLs , a spherical toric IOL , Acrys of SN60T ( Group A ) and a aspheric toric IOL , Acrts of SN6AT , ( 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 3 months after implantation .


The present study included 44 eyes .


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


The UDVA of 0.1 logMAR or better was found in 78.26 % in Group A and 85.71 % in Group B.


In Group A , 78.26 % of eyes and in Group B , 76.19 % had a refractive astigmatism value within 0.50 diopter at KP90 ( polar value along the 90-degree meridian ) .


The spherical equivalent ( SE ) was within 0.5 diopter of emmetropia in 91.30 % in Group A and in 80.95 % in Group B. Group B had significantly lower spherical aberration Z ( 4 , 0 ) 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-2000 and GH-2004 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-2000 score to recombinant human ( rh ) IGF-I/rhIGF binding protein-3 ( IGFBP-3 ) administration in recreational athletes .


This was a randomized , double-blind , placebo-controlled rhIGF-I/rhIGFBP -3 administration study at Southampton General Hospital ( Southampton , United Kingdom ) .


Fifty-six recreational athletes ( 26 women , 30 men ) participated in the study .


Participants were randomized to treatment with low-dose ( 30 mg/d ) or high-dose ( 60 mg/d ) rhIGF-I/rhIGFBP -3 complex or placebo for 28 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-2000 scores were calculated .


IGF-I , P-III-NP , and the GH-2000 score rose in response to both low - and high-dose rhIGF-I/rhIGFBP -3 administration .


The relative maximum response of IGF-I ( approximately 4-fold increase in women and men ) was greater than that of P-III-NP ( 40 % -50 % increase in women , 35 % -50 % increase in men ) .


The GH-2000 formulae , which incorporate IGF-I and P-III-NP results , detected up to 61 % of women and 80 % of men in the rhIGF-I/rhIGFBP -3 groups but , using IGF-I concentrations alone , the sensitivity increased to 94 % in both women and men during the administration period .


The rise in P-III-NP after rhIGF-I/rhIGFBP -3 administration is small compared with that after rhGH administration .


Although rhIGF-I/rhIGFBP -3 administration can be detected using the GH-2000 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 = 216 ) or because eligible but refusing to participate ( n = 116 ) .


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 ( 21.0 vs. 10.9 deaths/100 persons-year ; P < 0.001 ) .


The crude excess risk of death in non-eligible patients ( HR 1.96 ; 95 % CI 1.36 to 2.77 ; P < 0.001 ) 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 1.60 ; 95 % CI 1.10 to 2.35 ; P = 0.017 ) and almost nullified after including in the same model also information on deambulation impairment ( HR 1.16 ; 95 % CI 0.75 to 1.80 ; P = 0.513 ) .


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 4640 critically ill patients .


We investigated the effect of early vs late PN on any steroid treatment and on treatment for 5 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 = 174 ) 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 ( 26.2 % vs 23.8 % ; P = .05 ) and with corticosteroids for 5 days ( 14.0 % vs 11.9 % ; P = .03 ) .


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 ( 17.0 % ) than with late PN ( 14.2 % ) ( P = .01 ) .


In multivariate logistic regression analysis , new septic shock was an independent determinant for 5 days steroid treatment ( odds ratio , 6.25 ; 95 % confidence interval , 4.93-7 .94 ; P < .0001 ) , 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 .


78 adult patients undergoing elective CABG surgery were randomised to receive either an intravenous bolus of CsA ( 2.5 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 0 , 6 , 12 , 24 , 48 and 72 h after surgery .


There was no significant difference in mean peak cTnT levels between control ( n = 43 ) and CsA treatment ( n = 40 ) patients ( 0.560.06 ng/mL with control vs 0.350.05 ng/mL with CsA ; p = 0.07 ) .


However , in higher-risk patients with longer cardiopulmonary bypass times , there was a significant reduction in PMI with CsA therapy ( p = 0.049 ) , with a reduced postoperative cTnT rise by 0.03 ng/mL for every 10 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 22 % and 63 % , respectively .


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


After ViDOS , 7 process indicators were being newly implemented by more than 50 % 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 NCT01398527 .


Midazolam has been widely studied for preventing emergence agitation .


The authors previously reported that in children with sevoflurane anesthesia , intravenous administration of midazolam ( 0.05 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 , 90 children ( 1 to 13 yr of age ) having strabismus surgery were randomized to 1:1:1 to receive 0.03 mg/kg of midazolam , 0.05 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 0.03 mg/kg of midazolam ( 5 of 30 , 16.7 % ) and patients given 0.05 mg/kg of midazolam ( 5 of 30 , 16.7 % ) compared with that in patients given saline ( 13/of 30 , 43.3 % ; P = 0.036 each ) .


The emergence time was longer in patients given 0.05 mg/kg of midazolam ( 17.1 3.4 min , mean SD ) compared with that in patients given 0.03 mg/kg of midazolam ( 14.1 3.6 min ; P = 0.0009 ) or saline ( 12.8 4.1 min ; P = 0.0003 ) .


Intravenous administration of 0.03 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/4 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 18 years or older with laboratory supported probable , clinically probable , or clinically definite ALS ; stable riluzole treatment for at least 30 days ; and respiratory insufficiency .


We randomly assigned participants ( 1:1 ) , 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/4 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 53817913 .


Between Dec 5 , 2011 , and Dec 18 , 2013 , we randomly assigned 74 participants to receive either non-invasive ventilation alone ( n = 37 ) or non-invasive ventilation plus diaphragm pacing ( n = 37 ) .


On Dec 18 , 2013 , 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 23 , 2014 , when the DMEC advised discontinuation of pacing in all patients .


Follow-up assessments continued until the planned end of the study in December , 2014 .


Survival was shorter in the non-invasive ventilation plus pacing group than in the non-invasive ventilation alone group ( median 110 months [ 95 % CI 83-136 ] vs 225 months [ 136-not reached ] ; adjusted hazard ratio 227 , 95 % CI 122-425 ; p = 0009 ) .


28 ( 76 % ) patients died in the pacing group and 19 ( 51 % ) patients died in the non-invasive ventilation alone group .


We recorded 162 adverse events ( 59 events per person-year ) in the pacing group , of which 46 events were serious , compared with 81 events ( 25 events per person-year ) in the non-invasive ventilation alone group , of which 31 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 .


The National Institute for Health Research Health Technology Assessment Programme ; the Motor Neurone Disease Association of England , Wales , and Northern Ireland .


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 61 women from 2 urban medical practices who met criteria for major depressive disorder and chronic pelvic pain .


Participants were assigned to receive either 8 sessions of IPT or a facilitated psychotherapy referral to a community mental health center , and assessed for depression , social interactions , and pain at 0 - , 12 - , 24 - , and 36-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 .


Clinical Trials.gov , www.clinicaltrials.gov , NCT00895999 .


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 4-hydroxytamoxifen gel ( 4-OHT ) to oral tamoxifen ( oral-T ) in women with ductal carcinoma in situ ( DCIS ) .


Twenty-seven pre - and postmenopausal women were randomized to 4-OHT ( 4 mg/day ) or oral-T ( 20 mg/day ) for 6 to 10 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 Ki67 labeling in DCIS lesions , measured by immunohistochemistry .


In plasma , insulin-like growth factor-1 ( IGFI ) , sex hormone-binding globulin ( SHBG ) , and coagulation protein concentrations were determined .


Posttherapy Ki67 decreased by 3.4 % in the 4-OHT and 5.1 % in the oral-T group ( P 0.03 in both , between-group P = 0.99 ) .


Mean plasma 4-OHT was 0.2 and 1.1 ng/mL in 4-OHT and oral groups , respectively ( P = 0.0003 ) , whereas mean breast adipose tissue concentrations of 4-OHT were 5.8 ng/g in the 4-OHT group and 5.4 ng/g in the oral group ( P = 0.88 ) .


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 4-OHT .


The incidence of hot flashes was similar in both groups .


The antiproliferative effect of 4-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 3 months to assess changes in alcohol consumption .


A total of 741 hazardous drinking participants were recruited for the trial , of which 73 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 = .028 and .047 respectively ; no impact on highest number of drinks on one occasion ; p = .594 ) .


However , there was no significant evidence of the impact of the normative feedback components ( all p > .3 ) .


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


ClinicalTrials.gov NCT01608763 .


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


A total of 135 ( 73 female and 62 male ) Chinese-Canadian children ( aged 8-13 years ; mean [ SE ] age , 10.29 [ 0.15 ] years ; mean [ SE ] myopia , -3.08 [ 0.10 ] D ) with myopia progression of at least 0.50 D in the preceding year were randomly assigned to 1 of 3 treatments .


A total of 128 ( 94.8 % ) completed the trial .


Single-vision lenses ( control , n = 41 ) , +1.50 - D executive bifocals ( n = 48 ) , and +1.50 - D executive bifocals with 3 - base-in prism in the near segment of each lens ( n = 46 ) .


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 6 months for 36 months .


RESULTS Myopia progression over 3 years was an average ( SE ) of -2.06 ( 0.13 ) D for the single-vision lens group , -1.25 ( 0.10 ) D for the bifocal group , and -1.01 ( 0.13 ) D for the prismatic bifocal group .


Axial length increased an average ( SE ) of 0.82 ( 0.05 ) mm , 0.57 ( 0.07 ) mm , and 0.54 ( 0.06 ) mm , respectively .


The treatment effect of bifocals ( 0.81 D ) and prismatic bifocals ( 1.05 D ) was significant ( P < .001 ) .


Both bifocal groups had less axial elongation ( 0.25 mm and 0.28 mm , respectively ) than the single-vision lens group ( P < .001 ) .


For children with high lags of accommodation ( 1.01 D ) , the treatment effect of both bifocals and prismatic bifocals was similar ( 1.1 D ) ( P < .001 ) .


For children with low lags ( < 1.01 D ) , the treatment effect of prismatic bifocals ( 0.99 D ) was greater than of bifocals ( 0.50 D ) ( P = .03 ) .


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 0.50 D after 3 years .


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


TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT00787579 .


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 2 months to 2 years ) with high altitude heart disease associated with severe PAH , who were continuously transferred to the Intensive Care Unit between January 2011 and October 2013 , were randomly assigned to observation and control groups .


The control group was given conventional treatment , while the observation group received oral sildenafil [ 1 mg / ( kg.d ) ] three times daily for 7-10 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 < 0.05 ) .


In the observation group , there were no significant changes in mean arterial pressure , routine blood parameters and blood biochemical parameters ( P > 0.05 ) , 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 2009 .


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 .


After pneumoperitoneum induction , the remifentanil infusion rate was set to obtain two different levels of SPI ( > 50 , HI-SPI , and < 50 , LO-SPI ) for each patient .


Arterial pressure , heart rate ( HR ) , low-frequency and high-frequency spectral components , the low frequency/high frequency ratio ( measure of sympathovagal balance ) and whole power spectrum density of HRV were measured at the two different levels of SPI .


Thirty-nine patients were included in the final analysis .


During LO-SPI , HR and systolic and mean blood pressures were significantly lower than HI-SPI .


The median low frequency/high frequency ratio was reduced during LO-SPI [ 1.29 interquartile range ( IQR ) 0.66 to 2.05 ) vs. 2.36 ( 1.30 to 3.62 ) , P = 0.008 ] .


The sensitivity analysis revealed a significant correlation between SPI changes and changes of all ANS indices , arterial pressure and HR , with a slightly better correlation for low frequency/high frequency ( Spearman = 0.70 , IQR 0.484 to 0.834 , P < 0.001 ) .


In the context of a balanced general anaesthesia in healthy patients undergoing laparoscopic abdominal surgery , ANS modulation seems to correlate with changes in SPI .


Further studies are warranted to assess whether this may reflect a change in nociception/antinociception balance or a pharmacodynamic effect of remifentanil .


We evaluated the effects of a levosimendan ( LS ) - based strategy compared with standard inotropic therapy on renal function in heart transplantation .


Using a randomized study design , 94 patients were assigned to LS-based therapy or standard inotropic support .


At the time of transplantation , the groups did not differ in age , gender , heart failure etiology , hemodynamic profile , LVEF , or comorbidities .


While there were no differences in serum creatinine ( sCr ) or eGFR between groups at baseline , patients in the LS group had a greater increase in their relative eGFR ( 62 % vs. 12 % , p = 0.002 ) and a lower incidence of acute kidney injury ( AKI ) ( 28 % vs. 6 % , p = 0.01 ) during the first post-transplant week .


On logistic regression analysis , correlates of AKI were randomization to LS therapy ( OR = 0.21 [ 0.09-0 .62 ] , p = 0.01 ) , baseline renal dysfunction ( OR = 3.9 [ 1.1-13 .6 ] , p = 0.032 ) , and diabetes mellitus ( OR = 4.2 [ 1.1-16 .5 ] , p = 0.038 ) .


However , LS was associated with a greater need for additional norepinephrine therapy ( 40 [ 85 % ] vs. 15 [ 31 % ] , p < 0.001 ) and a trend toward longer intensive care unit stay ( 9.59.0 d vs. 7.06.0 d , p = 0.13 ) .


In patients undergoing heart transplantation , levosimendan-based strategy may be associated with better renal function when compared to standard therapy .


After measles vaccine ( MV ) , all-cause mortality is reduced more than can be explained by the prevention of measles , especially in females .


We aimed to study the biological mechanisms underlying the observed non-specific and sex-differential effects of MV on mortality .


Within a large randomised trial of MV at 4.5 months of age blood samples were obtained before and six weeks after randomisation to early MV or no early MV .


We measured concentrations of cytokines and soluble receptors from plasma ( interleukin-1 receptor agonist ( IL-1Ra ) , IL-6 , IL-8 , IL-10 , tumor necrosis factor ( TNF ) - , monocyte chemoattractant protein ( MCP ) -1 , soluble urokinase-type plasminogen activator receptor ) , and secreted cytokines ( interferon - , TNF - , IL-5 , IL-10 , IL-13 , IL-17 ) after in vitro challenge with innate agonists and recall antigens .


We analysed the effect of MV in multiple imputation regression , overall and stratified by sex .


The majority of the infants had previously been enrolled in a randomised trial of neonatal vitamin A. Post hoc we explored the potential effect modification by neonatal vitamin A.


Overall , MV versus no MV was associated with higher plasma MCP-1 levels , but the effect was only significant among females .


Additionally , MV was associated with increased plasma IL-1Ra .


MV had significantly positive effects on plasma IL-1Ra and IL-8 levels in females , but not in males .


These effects were strongest in vitamin A supplemented infants .


Vitamin A shifted the effect of MV in a pro-inflammatory direction .


In this explorative study we found indications of sex-differential effects of MV on several of the plasma biomarkers investigated ; in particular MV increased levels in females , most strongly in vitamin A recipients .


The findings support that sex and micronutrient supplementation should be taken into account when analysing vaccine effects .


clinicaltrials.gov number NCT 00168545 .


This cost analysis uses data from a randomized trial comparing a noprophylaxis versus prophylactic platelet ( PLT ) transfusion policy ( counts < 1010 ( 9 ) / L ) in adult patients with hematologic malignancies .


Results are presented for all patients and separately for autologous hematopoietic stem cell transplantation ( HSCT ) ( autoHSCT ) and chemotherapy/allogeneic HSCT ( chemo/alloHSCT ) patients .


Data were collected to 30 days on PLT and red blood cell ( RBC ) transfusions , major bleeds , serious adverse events , critical care , and hematology ward stay .


Data were costed using 2011 to 2012 UK unit costs and converted into US$ .


Sensitivity analyses were performed on uncertain cost variables .


Across the whole trial no prophylaxis saved costs compared to prophylaxis : - $ 1760 per patient ( 95 % confidence interval [ CI ] , - $ 3250 to - $ 249 ; p < 0.05 ) .


For autoHSCT patients there was no cost difference between arms : - $ 110 per patient ( 95 % CI , - $ 1648 to $ 1565 ; p = 0.89 ) .


For chemo/alloHSCT patients noprophylaxis cost significantly less than prophylaxis : - $ 5686 per patient ( 95 % CI , - $ 8580 to - $ 2853 ; p < 0.01 ) .


The cost impact of noprophylaxis differed significantly between subgroups .


Sensitivity analyses varying daily treatment costs and ward stay for chemo/alloHSCT patients reduced cost differences to - $ 941 per patient ( p = 0.21 ) across the whole trial and - $ 2927 per patient ( p < 0.05 ) in chemo/alloHSCT subgroup .


It is unclear whether a no-prophylaxis policy saves costs overall .


In chemo/alloHSCT patients cost savings are apparent but their magnitude is sensitive to a number of variables and must be considered alongside clinical data showing increased bleeding rates .


In autoHSCT patients savings generated through lower PLT use in no-prophylaxis arm were offset by cost increases elsewhere , for example , additional RBC transfusions .


Cost-effectiveness analyses of alternative PLT transfusion policies simultaneously considering costs and patient-reported outcomes are warranted .


After the fall of the Taliban regime , most clinics in Afghanistan were charging fees to patients .


The government invested in monitoring and evaluation systems for its newly rebuilt primary care system , but little was known about the effects of user fees .


This study was undertaken to provide evidence on user fees ' effects on quality and service utilization and to help inform development of health financing policy and strategy .


A quasi-experimental health financing pilot study was implemented in 2005 .


Forty-seven facilities were randomized to implement a standardized user fee intervention , offer free services , or serve as controls , continuing current cost-sharing systems .


Revenues were co-managed by staff and community leaders for facility improvement .


Baseline and follow-up facility assessments , exit interviews , and household surveys , as well as routine data were used to evaluate user fee effects over 2years .


Observed and perceived quality improved at most facilities but did not differ by study group .


Utilization increased in all groups , but the increase was 682 to 748 visits per month larger in facilities randomized to free services compared with those randomized to fees or controls ( p < 0.01 ) .


User fees demonstrated few beneficial effects and slowed the rate of increase of service utilization in Afghanistan .


In 2008 , the government abolished primary care fees , citing results of this study .


To explore the influence of different ways of blood transfusion on the expression levels of interleukins ( IL ) and tumor necrosis factor - ( TNF - ) inperi-operative patients with esophageal cancer .


A total of 80 patients with esophageal cancer who underwent radical operations were selected as study patients and randomly divided into an observation group ( treated with autologous blood transfusion ) and control group ( with homologous blood transfusion ) .


Changes of intra-operative indexes and peri-operative blood indexes , from hemoglobin ( Hb ) and hematocrit value ( Hct ) , to levels of inflammatory factors like interleukins-6 ( IL-6 ) , IL-8 , IL-10 and tumor necrosis factor - ( TNF - ) were compared .


Operations for patients in both groups were successfully conducted , and no significant differences in mean surgical duration and intra-operative hemorrhage volume , fluid infusion volume and blood transfusion volume were detected ( p > 0.05 ) .


Compared with values before surgery , Hb and Hct levels decreased significantly while white blood cell count ( WBC ) increased 1 , 5 and 7 d after operation ( p < 0.05 , p < 0.01 ) .


In addition , WBC was apparently higher in observation group than in control group 5 and 7 d after operation ( p < 0.01 ) .


Compared with before surgery , in the observation group , levels of IL-6 , IL-8 and IL-10 had no significant differences after operation ( P > 0.05 ) , but TNF - level increased y ( p < 0.01 ) , whereas in control group , IL-6 level had no significant difference ( p > 0.05 ) , IL-8 level decreased obviously ( p < 0.05 ) , IL-10 level increased markedly first and then decreased gradually as time passed but its level remained elevated ( p < 0.01 ) , and TNF - level increased first and then decreased , and there was no significant difference 7 d after operation ( p > 0.05 ) .