Plasma levels of both IL-6 and IL-10 determined at randomization correlated with severity of PCAS at day 2 ( r = 0.36 and r = 0.27 , p < 0.001 ) and day 3 ( r = 0.32 and r = 0.22 , p < 0.001 ) .


IL-6 at randomization was an independent predictor of severity of PCAS at day 2 ( p = 0.003 ) and day 3 ( p < 0.0001 ) and was a significantly stronger predictor of severity of PCAS at day 3 compared to CRP ( p = 0.04 ) and PCT ( p = 0.03 ) .


Level of TTM did not modify level of the inflammatory markers IL-1 , IL-6 , TNF - , IL-4 , IL-10 , CRP and PCT , ( p = NS for each inflammatory marker ) .


Level of inflammatory response was associated with severity of PCAS with IL-6 being consistently and more strongly associated with severity of PCAS than the inflammatory markers CRP and PCT .


The systemic inflammatory response after CA was not modified by TTM at 33 C or 36 C.


Potassium-channels in the carotid body and the brainstem are important regulators of ventilation .


The BKCa-channel contains response elements for CO , O2 , and CO2 .


Its block increases carotid body signalling , phrenic nerve activity , and respiratory drive .


GAL-021 , a new BKCa-channel blocker , increases minute ventilation in rats and non-human primates .


This study assessed the single-dose safety , tolerability , pharmacokinetics ( PKs ) , and pharmacodynamics ( PDs ) of GAL-021 in healthy volunteers .


Thirty subjects participated in a nine-period , randomized , double-blinded , placebo-controlled , crossover , ascending dose , first-in-human study with i.v. infusions of 0.1-0 .96 mg kg ( -1 ) h ( -1 ) for 1 h and intermediate doses up to 4 h.


Adverse event rates were generally similar among dose levels and between placebo - and GAL-021-treated subjects .


At higher GAL-021 doses , a mild/moderate burning sensation at the infusion site occurred during the infusion .


No clinically significant changes in vital signs or clinical chemistries were noted .


Minute ventilation increased ( AUE0-1 h 16 % , P < 0.05 ) and end-tidal carbon dioxide ( [ Formula : see text ] ) decreased ( AUE0-1 h 6 % , P < 0.05 ) during the first hour at 0.96 mg kg ( -1 ) h ( -1 ) with 1/2-maximal [ Formula : see text ] and [ Formula : see text ] - change occurring by 7.5 min .


Drug concentration rose rapidly during the infusion and decreased rapidly initially ( distribution t1/2 of 30 min ) and then more slowly ( terminal t1/2 of 5.6 h ) .


GAL-021 was safe and generally well tolerated with adverse events comparable with placebo except for an infusion site burning sensation .


GAL-021 stimulated ventilation at the highest doses suggesting that greater infusion rates may be required for maximum PD effects .


GAL-021 had PK characteristics consistent with an acute care medication .


This study evaluates the efficacy and safety of a sufentanil sublingual tablet system ( SSTS ) for the management of postoperative pain following open abdominal surgery .


At 13 hospital sites in the United States , patients following surgery with pain intensity of greater than 4 on an 11-point numerical rating scale were randomized to receive SSTS dispensing a 15-g sufentanil tablet sublingually with a 20-minute lockout or an identical system dispensing a placebo tablet sublingually .


Pain intensity scores were recorded at baseline and for up to 72 hours after starting study drug .


The primary end point was time-weighted summed pain intensity difference ( SPID ) over 48 hours .


Secondary end points included SPID and total pain relief ( TOTPAR ) for up to 72 hours and patient and health care provider global assessments of the method of pain control .


Summed pain intensity difference over 48 hours was significantly higher in the SSTS group than in the placebo group ( least squares mean [ SEM ] , 105.60 [ 10.14 ] vs 55.58 [ 13.11 ] ; P = 0.001 ) .


Mean SPID and TOTPAR scores were significantly higher in the SSTS group at all time points from 1 hour ( SPID ) or 2 hours ( TOTPAR ) until 72 hours ( P < 0.05 ) .


In the SSTS group , patient global assessment and health care provider global assessment ratings of good or excellent were greater than placebo at all time points ( P < 0.01 ) .


Safety parameters , including adverse events and vital signs , were similar for SSTS and placebo .


These results suggest that SSTS is effective and safe for the management of postoperative pain in patients following open abdominal surgery .


To investigate whether sacral nerve stimulation reduces irritable bowel syndrome ( IBS ) - specific symptoms by a randomized , controlled , crossover study .


IBS affects 3 % to 22 % of the population worldwide , but most patients continue to have symptoms despite treatment .


Patients included from our tertiary center had diarrhea-predominant or mixed IBS , with a minimum baseline IBS symptom score ( Gastrointestinal Syndrome Rating Scale-IBS questionnaire ) of 40 points reduced by a minimum of 30 % during the percutaneous nerve evaluation before permanent implantation .


Patients were randomized ( 1:1 ) to have the stimulator ON or OFF for 1 month and then the opposite for another month .


Investigators and patients were not informed of the setting .


IBS-specific symptoms and quality of life were assessed through bowel diaries and validated questionnaires .


Primary endpoint was the IBS-specific symptom score .


Twenty-one patients were randomized .


Ten were eligible for analysis in each group .


IBS-specific symptom scores were significantly reduced during stimulation : the median difference in the ON-OFF group was 12 ( range , -22 to 44 ) and in the OFF-ON group -17.5 ( range , -48 to -1 ) ( P = 0.0009 ) .


IBS-specific quality-of-life scores improved significantly during stimulation : the median difference in the ON-OFF group was 16 ( range , -24 to 69 ) and in the OFF-ON group -42.5 ( range , -77 to 0 ) ( P = 0.0003 ) .


At 1-year follow-up , the median IBS-specific symptom score ( 25 ; range , 13-65 ) was significantly lower than that at baseline ( 62 ; range , 45-80 ) ( P = 0.0001 ) .


Sacral nerve stimulation significantly reduces symptoms and improves quality of life of highly selected patients with IBS .


Tenofovir ( TDF ) is associated with phosphaturia and elevated 1,25 dihydroxy vitamin D ( 1,25-OH ( 2 ) D ) .


Fibroblast growth factor 23 ( FGF23 ) causes phosphaturia and increases in response to elevated 1,25-OH ( 2 ) D. Vitamin D-binding protein ( VDBP ) binds to 1,25-OH ( 2 ) D , decreasing its biological activity , and is elevated in individuals with higher plasma tenofovir concentrations .


We compared FGF23 and VDBP before and after vitamin D3 ( VITD ) supplementation in youths treated with combination antiretroviral therapy ( cART ) containing or not containing TDF .


A randomized controlled trial in HIV-positive youths aged 18-25 years enrolled participants based on cART treatment with TDF ( TDF ; n = 118 ) or without TDF ( no-TDF ; n = 85 ) , and randomized within those groups to VITD ( 50,000 IU every 4 weeks ) or placebo ( PL ) .


We measured FGF23 and VDBP and calculated free 1,25-OH ( 2 ) D at baseline and week 12 , and compared changes by TDF treatment and VITD randomized group .


At baseline , serum FGF23 concentration showed a quadratic relationship with 1,25-OH ( 2 ) D most pronounced in the TDF group .


At week 12 , total and free 1,25-OH ( 2 ) D increased in the VITD but not PL groups , independent of TDF use .


FGF23 increased in the TDF group receiving VITD , but there was no FGF23 change in the no-TDF group receiving VITD or the PL groups .


The adjusted mean change in FGF23 from baseline to week 12 was 7.7 pg/ml in the TDF/VITD group , compared with -1.7 ( no-TDF/VITD , P = 0.010 ) , -1.3 ( TDF/PL , P = 0.006 ) and 1.1 ( no-TDF/PL , P = 0.035 ) .


These results suggest that TDF-containing cART may alter the FGF23 response to vitamin D supplementation in HIV-infected youths .


Clinical trials number : NCT00490412 .


High level of serum cholesterol is considered to be a major risk factor for cardiovascular disease ( CVD ) .


A double-blinded , randomized , placebo-controlled trial was performed to test the hypothesis that a daily intake of Chlorella may improve serum lipid profile through enhancement of serum carotenoid concentration in mildly hypercholesterolemic subjects .


Eligible subjects ( n = 63 ) were randomized to either Chlorella ( 5g/day ) or placebo for a double-blinded trial with a 2-week lead-in period and a 4-week intervention period .


Serum triglycerides , total cholesterol , lipoproteins , apolipoproteins and carotenoids were assessed at the beginning and the end of the trial .


Compared with the control group , the Chlorella group exhibited remarkable changes in total cholesterol ( Chlorella -1.6 % ; placebo 0.03 % ; P = 0.036 ) , triglycerides ( Chlorella -10.3 % ; placebo 11.9 % ; P = 0.002 ) , lutein/zeaxanthin ( Chlorella 89.6 % ; placebo -1.7 % ; P < 0.0001 ) , and - carotene ( Chlorella 163.6 % ; placebo 15 % ; P < 0.0001 ) .


Improvement of serum lipids was supported by significant reductions of very low-density lipoprotein cholesterol ( Chlorella -11 % ; placebo 11.8 % ; P = 0.006 ) , apolipoprotein B ( Chlorella -1.5 % ; placebo 1.7 % ; P = 0.044 ) , non high-density lipoprotein ( Chlorella -2.6 % ; placebo -0.5 % ; P = 0.032 ) , and high-density lipoprotein/triglycerides ( Chlorella 4.0 % ; placebo -9.5 % ; P = 0.023 ) , suggesting an inhibitory effect of Chlorella on the intestinal absorption of dietary and endogenous lipids .


Further , the changes of serum lipids appeared to be associated with the changes of serum carotenoids .


Daily consumption of Chlorella supplements provided the potential of health benefits reducing serum lipid risk factors , mainly triglycerides and total cholesterol , in mildly hypercholesterolemic subjects .


The effect was related to carotenoid consumption .


WHO International Clinical Trials Registry Platform KCT0000259 .


Zinc sulfate is beneficial in the treatment of epithelial warts .


We conducted this study to compare the efficacy of combination therapy of oral zinc sulfate with conventional treatments in the treatment of vulvar warts .


This study was a randomized controlled trial .


The sample size was 42 in each group .


Women aged 20-50 years were placed by the block randomized method into six groups : the podophyllin - , imiquimod - and cryotherapy-treated groups , and another three groups receiving 8-week combination therapy of 400mg oral zinc sulfate with one of the above-mentioned treatments .


Data were analyzed using anova and Fischer 's exact test with spss16 .


A total of 228 patients were recruited and completed the study in six treatment groups .


No significant difference was observed in the response to treatment among these groups .


Relapse after 6 months was significantly higher in the podophyllin - , imiquimod - and cryotherapy-treated patients compared to patients receiving these treatments in combination with oral zinc sulfate ( P < 0.05 ) .


Combined therapy of oral zinc sulfate with conventional treatments of vulvar warts appears to reduce the relapse rate .


Laryngoscopy and endotracheal intubation in the presence of cervical spine instability may put patients at risk of cervical cord injury .


Nevertheless , the biomechanics of intubation ( cervical spine motion as a function of applied force ) have not been characterized .


This study characterized and compared the relationship between laryngoscope force and cervical spine motion using two laryngoscopes hypothesized to differ in force .


Fourteen adults undergoing elective surgery were intubated twice ( Macintosh , Airtraq ) .


During each intubation , laryngoscope force , cervical spine motion , and glottic view were recorded .


Force and motion were referenced to a preintubation baseline ( stage 1 ) and were characterized at three stages : stage 2 ( laryngoscope introduction ) ; stage 3 ( best glottic view ) ; and stage 4 ( endotracheal tube in trachea ) .


Maximal force and motion occurred at stage 3 and differed between the Macintosh and Airtraq : ( 1 ) force : 48.8 15.8 versus 10.4 2.8 N , respectively , P = 0.0001 ; ( 2 ) occiput-C5 extension : 29.5 8.5 versus 19.1 8.7 degrees , respectively , P = 0.0023 .


Between stages 2 and 3 , the motion/force ratio differed between Macintosh and Airtraq : 0.5 0.2 versus 2.0 1.4 degrees/N , respectively ; P = 0.0006 .


The relationship between laryngoscope force and cervical spine motion is : ( 1 ) nonlinear and ( 2 ) differs between laryngoscopes .


Differences between laryngoscopes in motion/force relationships are likely due to : ( 1 ) laryngoscope-specific cervical extension needed for intubation , ( 2 ) laryngoscope-specific airway displacement/deformation needed for intubation , and ( 3 ) cervical spine and airway tissue viscoelastic properties .


Cervical spine motion during endotracheal intubation is not directly proportional to force .


Low-force laryngoscopes can not be assumed to result in proportionally low cervical spine motion .


Surgical resection enhances long-term survival after lung cancer , but survivors face functional deficits and report on poor quality of life long time after surgery .


This study evaluated short and long-term effects of supervised group exercise training on health-related quality of life and physical performance in patients , who were radically operated for lung cancer .


A randomized , assessor-blinded , controlled trial was performed on 78 patients undergoing lung cancer surgery .


The intervention group ( IG , n = 41 ) participated in supervised out-patient exercise training sessions , one hour once a week for ten weeks .


The sessions were based on aerobic exercises with target intensity of 60-80 % of work capacity , resistance training and dyspnoea management .


The control group ( CG , n = 37 ) received one individual instruction in exercise training .


Measurements consisted of : health-related quality of life ( SF36 ) , six minute walk test ( 6MWT ) and lung function ( spirometry ) , assessed three weeks after surgery and after four and twelve months .


Both groups were comparable at baseline on demographic characteristic and outcome values .


We found a statistically significant effect after four months in the bodily pain domain of SF36 , with an estimated mean difference ( EMD ) of 15.3 ( 95 % CI :4 to 26.6 , p = 0.01 ) and a trend in favour of the intervention for role physical functioning ( EMD 12.04 , 95 % CI : -1 to 25.1 , p = 0.07 ) and physical component summary ( EMD 3.76 , 95 % CI : -0.1 to 7.6 , p = 0.06 ) .


At 12 months , the tendency was reversed , with the CG presenting overall slightly better measures .


We found no effect of the intervention on 6MWT or lung volumes at any time-point .


Supervised compared to unsupervised exercise training resulted in no improvement in health-related quality of life , except for the bodily pain domain , four months after lung cancer surgery .


No effects of the intervention were found for any outcome after one year .


This prospective randomized Phase II study was designed to evaluate the preventive effect of an oral nutrition supplement composed of beta-hydroxy-beta-methylbutyrate , arginine and glutamine ( beta-hydroxy-beta-methylbutyrate / arginine/glutamine ) on radiation dermatitis in head and neck cancer patients .


Forty patients with histologically proven head and neck cancer , treated with concurrent chemoradiotherapy involving cisplatin were recruited .


They were randomly assigned to the beta-hydroxy-beta-methylbutyrate / arginine/glutamine supplement treatment group ( Group A ) or the control group that received no supplement ( Group B ) .


The primary endpoint of this study was the percentage of patients developing Grade 3 dermatitis .


The secondary endpoints were the percentage of patients developing Grade 2 dermatitis , and the duration of each grade of dermatitis relative to the observation period .


The incidence of Grade 3 dermatitis did not differ between the two groups .


However , as secondary endpoints of this study , the incidence of Grade 2 dermatitis was lower in Group A than B ( 62.6 vs. 94.4 % ; P < 0.05 ) , and the duration of Grade 1 dermatitis was shorter in Group A than B ( 44.8 vs. 56.7 % ; P < 0.01 ) , as was the duration of Grade 2 dermatitis ( 16.5 vs. 26.5 % ; P < 0.05 ) .


Our study indicated that beta-hydroxy-beta-methylbutyrate / arginine/glutamine supplementation was potentially effective in the prevention of radiation dermatitis in head and neck cancer patients .


Applied Kinesiology ( AK ) is a diagnostic technique widely used within the Integrative Medical community .


In essence , it posits that a question can be mentally held in a person 's mind , sometimes while they are holding a substance like a vitamin , or a food sample , and by measuring relative muscular weakness an answer as to whether the substance or the condition represented by the question is good for that person can be obtained .


This AK is presumed to have a diagnostic capability .


That being presumed , this study asks the following questions : ( 1 ) Is there a difference in muscular strength when an individual holds a substance that is inimical to life processes ( a poison solution ) , as compared to a substance that is essential for life ( normal saline ) ?


( 2 ) Is this effect a transaction involving input from both the person being measured and the kinesiologist doing the measurement or is it only the person being measured ?


( 3 ) As an extension of question 2 , is the result the same when different kinesiologists take the measurement or when no kinesiologist is involved ?


( 4 ) Does belief , expectation , gender , or time cognition play a role in determining response ?


To answer these questions , which would help to define the parameters of the AK process , 51 participants were tested during three trials each , first by one kinesiologist , then by another , and finally , with no kinesiologist present by grip strength indicated using a hand dynamometer .


Grip strength being a self-administered AK test of relative muscular strength .


For each trial , a pair of randomly numbered sealed vials , each pair in a randomly numbered plastic bag , were used as the objects of the trial .


In each bag , one vial contained saline solution while the other was filled with a slightly smaller amount of saline solution to which had been added ionic hydroxylamine hydrochloride ( NH3OH ) ( + ) , producing a toxic solution of 9mg/ml .


Each trial consisted of a separate muscle test for each vial .


All present at the trials were blind as to which vial contained the toxin .


And all who prepared the vials were blind to the trials .


The force used by the kinesiologists in each of their trials was measured via a pressure pad system .


The hand dynamometer trials were conducted with no kinesiologist present .


Of the 151 sets of trials , the toxic vial was identified correctly in 80 of them ( 53 % ) , resulting in a one-tailed exact binomial P-value of .258 .


Results for two of the kinesiologists were almost exactly at chance .


For the third kinesiologist , there was a one-tailed exact binomial P-value of .18 ( unadjusted for multiple testing ) .


Results for the dynamometer were also almost exactly at chance .


Testing whether there was a significant difference in proportions for whom the AK test worked based on belief about whether it would work resulted in non-significant ( 2 ) values of 0.6 ( P = .439 ) for the trials with one kinesiologist and 2.222 ( P = .136 ) for the hand dynamometer trials .


The final variable examined was gender .


While there was no significant difference in performance for males and females for the trials of the male kinesiologist or the hand dynamometer , the combined data for the two female kinesiologists did reveal a difference .


Of the 33 sessions with females , only 15 were successful ( 45 % ) , while for the 18 sessions with males , 14 were successful ( 78 % ) , resulting in a ( 2 ) statistic of 4.96 , P = .026 .


However , given all of the ( 2 ) tests performed in this section , the results must be interpreted with caution because of multiple testing .


Results indicate belief in whether the AK test will work was not significantly related to whether it actually did work .


A ( 2 ) test of the relationship between time perception and correct vial choice showed no significant relationships .


The ( 2 ) statistic for the relationship using the hand dynamometer data was 0.927 , P = .629 .


The data in this study , particularly when seen in the larger context of a review of the literature from the AK field itself by Klinkoski and Leboeuf ( 1990 ) , which considered 50 papers published between 1981 and 1987 by the International College of Applied Kinesiology , and the survey by Hall , Lewith , Brien , and Little ( 2008 ) , using standard evaluation criteria [ quality assessment tool for studies of diagnostic accuracy included in systematic reviews ( QUADAS ) , Standards for Reporting of Diagnostic Studies ( STARD ) , JADAD , and Consolidated Standards of Reporting Trials ( CONSORT ) ] , for research methodology , as well as six prior non-clinical studies by Radin ( 1984 ) , Quintanar and Hill ( 1988 ) , Braud ( 1989 ) , Arnett et al. ( 1999 ) , Ludtke ( 2001 ) , and Kendler and Keating ( 2003 ) , all together suggest the following : The research published by the Applied Kinesiology field itself is not to be relied upon , and in the experimental studies that do meet accepted standards of science , Applied Kinesiology has not demonstrated that it is a useful or reliable diagnostic tool upon which health decisions can be based .


The phosphodiesterase type 5 inhibitor tadalafil is approved for the treatment of signs and symptoms of benign prostatic hyperplasia ( BPH ) .


While tadalafil significantly improves overall lower urinary tract symptoms suggestive of BPH ( LUTS/BPH ) , improvements in nocturia were not significant in individual studies .


We therefore sought to further assess nocturia based on data integrated from four tadalafil registrational studies .


Data were integrated from four randomized , placebo-controlled , double-blind , 12-week registrational studies of tadalafil for LUTS/BPH .


Nocturia was assessed as nighttime voiding frequency using the International Prostate Symptom Score question 7 ( IPSS Q7 ) .


Efficacy results were analyzed using analysis of covariance .


For the tadalafil 5 mg once daily ( N = 752 ) and placebo ( N = 748 ) groups , baseline characteristics were well balanced , and the overall severity of nocturia per mean IPSS Q7 was 2.3 1.2 .


The mean treatment change was -0.4 with placebo and -0.5 with tadalafil ; the least-squares mean ( standard error ) treatment difference was -0.2 ( 0.05 ) , p = 0.002 .


For patients receiving placebo and tadalafil , respectively , the proportion with improved nocturnal frequency was 41.3 and 47.5 % , with no change was 44.8 and 41.0 % , and with worsening was 13.9 and 11.5 % .


A statistically significant improvement in nocturnal frequency was seen with tadalafil over placebo ; however , the treatment difference was small and not considered clinically meaningful .


Further studies using voiding diaries and excluding patients with nocturnal polyuria would be needed to more precisely estimate the impact of tadalafil on nocturia associated with LUTS/BPH .


To evaluate whether 6.6-mm long implants could be a suitable alternative to longer implants placed in vertically augmented atrophic posterior mandibles .


Sixty partially edentulous patients having 7 to 8 mm of residual crestal height and at least 5.5 mm thickness measured on CT scans above the mandibular canal were randomised according to a parallel group design .


They were either to receive 1 to 3 submerged 6.6-mm long implants or 9.6 mm or longer implants ( 30 patients per group ) placed in vertically augmented bone .


Bone was augmented with interpositional anorganic bovine bone blocks covered by resorbable barriers .


Grafts were left to heal for 5 months before implant placement .


Four months after provisional acrylic prostheses were delivered , they were replaced , after 4 months , by definitive metal-ceramic prostheses .


Outcome measures were : prosthesis and implant failures ; complications ; and radiographic peri-implant marginal bone level changes .


All patients were followed up to 5 years after loading .


Five years after loading , 8 patients dropped out : 3 from the short implant group and 5 from the augmented group .


The augmentation procedure failed in 2 patients and only 6.6-mm long implants could be inserted .


There were no statistically significant differences for prosthesis and implant failures .


Five prostheses failed in 4 patients of the short implant group versus 5 prostheses in 5 patients in the augmented group ( Fishers exact test P = 1.0 ; difference in proportions = 0.07 ; 95 % CI -0.29 to 0.43 ) .


Five short implants failed in 3 patients versus 3 long implants in 3 patients ( Fishers exact test P = 1.00 difference in proportions = 0.00 ; 95 % CI -0.43 to 0.43 ) .


There were statistically more complications in augmented patients ( 25 complications in 21 augmented patients versus 6 complications in 6 patients of the short implant group ) ( Fishers exact test P < 0.0001 ; difference in proportions = 0.60 ; 95 % CI 0.38 , 0.82 ) .


Both groups gradually lost peri-implant bone in a statistically significant way .


Five years after loading , short implant group patients lost an average of 1.49 mm peri-implant bone compared with 2.34 mm in the augmented group .


Short implants experienced statistically significantly less bone loss ( 0.82 mm , 95 % CI 0.48 ; 1.16 , P < 0.0001 ) than long implants .


When residual bone height over the mandibular canal is between 7 to 8 mm , 6.6 mm short implants could be an interesting alternative to vertical augmentation in posterior atrophic mandibles since the treatment is faster , cheaper and associated with less morbidity .


Longer follow-ups may still be needed to confirm these results , however the medium-term prognosis ( 5 years after loading ) of short implants is at least as good as those of longer implants placed vertically in augmented mandibles .


Pilonidal sinus disease is associated with significant morbidity after surgical treatment with regard to wound healing .


Recent case studies suggested that negative-pressure wound therapy as primary treatment following surgical excision may shorten the duration of wound healing .


The purpose of this randomized controlled trial was to evaluate the role of vacuum therapy in pilonidal sinus disease : negative-pressure wound therapy versus standard open wound care after surgical excision .


Patients were randomly assigned to either negative-pressure wound therapy for 2 weeks or standard open wound healing .


The primary end point of the study was the time to complete wound healing .


Secondary end points were visual analog scale score , wound size ratio at day 14 ( ie , wound healing rate ) , time to resume daily activities , and recurrence within 6 months after wound closure .


Forty-nine patients were included in the study : 24 patients were treated with vacuum therapy , and 25 patients underwent standard open wound care .


Complete wound healing was achieved at a median of 84 days in the vacuum therapy group versus 93 days in control patients ( p = 0.44 ) .


The wound size ratio was significantly lower in the vacuum therapy group ( 0.30 versus 0.57 , p = 0.02 ) , ie , higher wound healing rate in the first 2 weeks .


There was no difference in visual analog scale scores and disease recurrence between both groups .


The time to resume full daily activities after surgery was 27 days in the patients undergoing vacuum therapy and 29 days in the control patients ( p = 0.92 ) .


This study is limited by the small number of patients , the lack of blinding to patients and doctors , and the absence of patient quality-of-life evaluation .


It is feasible to apply vacuum therapy in the treatment of pilonidal sinus disease , and it has a positive effect on wound size reduction in the first 2 weeks .


However , there is no difference in time to complete wound healing and time to resume daily life activities .


Plasmodium falciparum malaria is treated with 25 mg/kg of chloroquine ( CQ ) irrespective of age .


Theoretically , CQ should be dosed according to body surface area ( BSA ) .


The effect of dosing CQ according to BSA has not been determined but doubling the dose per kg doubled the efficacy of CQ in children aged < 15 years infected with P. falciparum carrying CQ resistance causing genes typical for Africa .


The study aim was to determine the effect of age on CQ concentrations .


Day 7 whole blood CQ concentrations were determined in 150 and 302 children treated with 25 and 50 mg/kg , respectively , in previously conducted clinical trials .


CQ concentrations normalised for the dose taken in mg/kg of CQ decreased with decreasing age ( p < 0.001 ) .


CQ concentrations normalised for dose taken in mg/m ( 2 ) were unaffected by age .


The median CQ concentration in children aged < 2 years taking 50 mg/kg and in children aged 10-14 years taking 25 mg/kg were 825 ( 95 % confidence interval [ CI ] 662-988 ) and 758 ( 95 % CI 640-876 ) nmol/l , respectively ( p = 0.67 ) .


The median CQ concentration in children aged 10-14 taking 50 mg/kg and children aged 0-2 taking 25 mg/kg were 1521 and 549 nmol/l .


Adverse events were not age/concentration dependent .


CQ is under-dosed in children and should ideally be dosed according to BSA .


Children aged < 2 years need approximately double the dose per kg to attain CQ concentrations found in children aged 10-14 years .


Clinical trials assessing the efficacy of CQ in Africa are typically performed in children aged < 5 years .


Thus the efficacy of CQ is typically assessed in children in whom CQ is under dosed .


Approximately 3 fold higher drug concentrations can probably be safely given to the youngest children .


As CQ resistance is concentration dependent an alternative dosing of CQ may overcome resistance in Africa .


To compare the safety and efficacy of fibrin glue and cyanoacrylate glue for refixating the recessed muscle to the sclera in patients undergoing strabismus surgery .


In this prospective , randomized , and interventional case series , there were 15 patients in each group .


Two different types of glue were used for refixating the muscle to the sclera after its recession : fibrin glue ( fibrin group ) and cyanoacrylate glue ( cyanoacrylate group ) .


Resection was performed as usual with a 6-0 polyglactin suture .


The conjunctiva was closed with the same glue that was used for muscle recession .


Average time required per muscle attachment was 1.480.694 minutes in the fibrin group and 2.420.584 minutes in the cyanoacrylate group .


There was no significant difference in pain at all postoperative visits in both groups .


Significantly more chemosis was observed in the cyanoacrylate group at postoperative 3 weeks .


At all other postoperative visits , there was no significant difference in chemosis in both groups .


There was significantly more conjunctival reaction in the cyanoacrylate group at 1 and 3 weeks and 3 months ; the difference was highly significant at 3 months ( P = .00 ) .


Total inflammatory score was significantly high in the cyanoacrylate group at 1 week , 3 weeks , and 3 months .


Both fibrin and cyanoacrylate glue are equally efficacious for muscle reattachment ; however , fibrin glue is more biotolerant compared to cyanoacrylate glue and results in less postoperative inflammation , and is thus recommended for recession in strabismus surgery .


Stratification of patients for treatment of ductal carcinoma in situ ( DCIS ) is suboptimal , with high systemic overtreatment rates .


A training set of 95 tumours from women with pure DCIS were immunostained for proteins involved in cell survival , hypoxia , growth factor and hormone signalling .


A generalised linear regression with regularisation and variable selection was applied to a multiple covariate Cox survival analysis with recurrence-free survival 10-fold cross-validation and leave-one-out iterative approach were used to build and test the model that was validated using an independent cohort of 58 patients with pure DCIS .


The clinical role of a COX-2-targeting agent was then tested in a proof-of-concept neoadjuvant randomised trial in ER-positive DCIS treated with exemestane 25 mg day ( -1 ) celecoxib 800 mg day ( -1 ) .


The COX-2 expression was an independent prognostic factor for early relapse in the training ( HR 37.47 ( 95 % CI : 5.56-252 .74 ) P = 0.0001 ) and independent validation cohort ( HR 3.9 ( 95 % CI : 1.8-8 .3 ) P = 0.002 ) .


There was no significant interaction with other clinicopathological variables .


A statistically significant reduction of Ki-67 expression after treatment with exemestane celecoxib was observed ( P < 0.02 ) with greater reduction in the combination arm ( P < 0.004 ) .


Concomitant reduction in COX-2 expression was statistically significant in the exemestane and celecoxib arm ( P < 0.03 ) only .


In patients with DCIS , COX-2 may predict recurrence , aiding clinical decision making .


A combination of an aromatase inhibitor and celecoxib has significant biological effect and may be integrated into treatment of COX2-positive DCIS at high risk of recurrence .


The objective of the present study was to investigate the effect of probiotic Lactobacillus casei Shirota on the values of mutans streptococci counts in saliva .


31 children were included in this double blinded study .


Study design included 4 periods which consisted of a run in period , two intervention periods and a washout period .


During the intervention periods children were either given probiotic milk or control milk for 10 days .


Pre and post intervention salivary samples were subjected to microbiological evaluation .


Then numbers of mutans streptococci were taken by identifying colony morphology .


A statistically significant reduction of mutans streptococci colony count was noted in the probiotic group ( p = .003 ) .


The reduction in children with higher levels of mutans streptococci ( 105 ) after intervention was 34 % in the probiotic group .


Daily consumption of milk containing probiotic bacteria can reduce the levels of mutans streptococci and may contribute to the prevention of dental caries .


This study introduces a new device to facilitate perforation size measurement during `` butterfly '' myringoplasty .


The purpose of this study is to evaluate the use of ` otological compass ' on short-term results of inlay cartilaginous ` butterfly ' tympanoplasty technique in adult patients .


Prospective , randomized , controlled , blinded .


This study included 25 patients who underwent inlay cartilage myringoplasty .


All operations were performed under general anesthesia by the same surgeon with a microscope-assisted approach .


The patients were divided randomly and consecutively into two groups : Group 1 ( n = 12 ) had perforation dimensions and shape measured using the Otologic Compass ( OC ) and the control group ( n = 13 ) had perforation measured by means of a Fisch elevator .


The duration of surgery , number of trials for correct placement of the cartilage graft , results and complications of the surgery were evaluated and compared .


The mean follow-up duration was 6 months .


Groups were similar in terms of age and perforation diameters ( p > 0.05 ) .


Average number of cartilage shaping before satisfactory graft fitting was significantly fewer in the OC group : 1.1 0.3 and 2.2 0.6 trials for OC and control groups , respectively ( p < 0.001 ) .


Mean duration of preparation and satisfactory graft fitting was 9.6 4.2 minutes in the OC group whereas it was 18.1 5.2 minutes for the control group .


Operative duration was significantly shorter in the OC group ( p < 0.001 ) .


At the end of the follow-up period , successful closure occurred 91.7 % and 84.6 % patients in the OC and control groups , respectively ( p > 0.05 ) .


The mean preoperative to postoperative three-tone air-bone gap improved 7.9 dB and 9.0 dB in OC and control groups , respectively ( p > 0.05 ) .


This study shows that OC presents as a useful tool that expedites and refines butterfly myringoplasty procedure .


The number of cartilage shaping prior to satisfactory graft fitting revealed significantly better results : almost all surgeries in the OC group were complete after a single cartilage shaping attempt .


Attrition is common in alcohol clinical trials and the resultant loss of data represents an important methodological problem .


In the absence of a simulation study , the drinking outcomes among those who are lost to follow-up are not known .


Individuals who drop out of treatment and continue to provide drinking data , however , may be a reasonable proxy group for making inferences about the drinking outcomes of those lost to follow-up .


We used data from the COMBINE study , a multisite , randomized clinical trial , to examine drinking during the 4months of treatment among individuals who dropped out of treatment but continued to provide drinking data ( i.e. , `` treatment dropouts ; '' n = 185 ) .


First , we estimated the observed treatment effect size for naltrexone versus placebo in a sample that included both treatment completers ( n = 961 ) and treatment dropouts ( n = 185 ; total N = 1,146 ) , as well as the observed treatment effect size among just those who dropped out of treatment ( n = 185 ) .


In both the total sample ( N = 1,146 ) and the dropout sample ( n = 185 ) , we then deleted the drinking data after treatment dropout from those 185 individuals to simulate missing data .


Using the deleted data sets , we then estimated the effect of naltrexone on the continuous outcome percent heavy drinking days using 6 methods to handle missing data ( last observation carried forward , baseline observation carried forward , placebo mean imputation , missing = heavy drinking days , multiple imputation ( MI ) , and full information maximum likelihood [ FIML ] ) .


MI and FIML produced effect size estimates that were most similar to the true effects observed in the full data set in all analyses , while missing = heavy drinking days performed the worst .


Although missing drinking data should be avoided whenever possible , MI and FIML yield the best estimates of the treatment effect for a continuous outcome measure of heavy drinking when there is dropout in an alcohol clinical trial .


There is evidence that neurofibrillary tangle ( NFT ) burden is associated with psychotic symptoms in Alzheimer disease ( AD ) .


However , it is not clear whether this association is direct or mediated through the increased cognitive impairment associated with NFTs .


We sought to determine whether the extended MAPT haplotype was associated with the worsening of delusions and hallucinations in a combined cohort of 95 patients who participated in 2 clinical trials of treatment with memantine .


After controlling for baseline dementia severity , exposure to memantine , and antipsychotics , analysis shows that carriers of at least one H2 allele had a 5.4-fold ( P = .03 ) increased risk of worsening hallucinations .


There was some evidence of association with worsening delusions but only in analysis by allele .


These results are the first to indicate that the H2 allele of the extended MAPT haplotype negatively affects the course of psychotic symptoms in AD independently of disease severity .


It will be important for future research to examine MAPT transcription in people with AD with and without psychotic symptoms to understand the exact mechanisms underlying these findings .


We introduced an initial large dose of modified St. Thomas ' Hospital cardioplegic solution with the aim of providing both myocardial protection as well as a smooth intraoperative process .


In 90 cases of isolated aortic valve replacement , we used the modified technique of cardioplegia in 45 ( group S ) and conventional administration of glucose-insulin-potassium solution in 45 ( group G ) .


The patients were selected at random .


In group S , we added 4 mEq of potassium to the original St. Thomas ' Hospital solution and administered 30mLkg ( -1 ) as an initial dose .


The temperature was decreased to 2 .


The mean of reperfusion time after declamping in group S was significantly shorter ( 16.7 6.4 vs. 21.5 10.0 min ; p = 0.007 ) .


The average of postoperative maximum creatine kinase-MB was significantly lower in group S ( 25.6 9.5 vs. 40.6 37.2 IUL ( -1 ) ; p = 0.014 ) .


On multivariate analysis , use of the modified cardioplegia and aortic crossclamp time were significantly associated with creatine kinase-MB level and reperfusion time after declamping .


This modified technique was an acceptable option that provided a bloodless operative field and avoided multiple cardioplegic administrations .


Vitamin D and its metabolites have potent immunomodulatory effects in vitro , including up-regulation of cathelicidin , a critical antimicrobial protein .


We investigated whether administration of 1,25-dihydroxyvitamin D ( calcitriol ) to critically ill patients with sepsis would have beneficial effects on markers of innate immunity , inflammation , and kidney injury .


We performed a double-blind , randomized , placebo-controlled , physiologic study among 67 critically ill patients with severe sepsis or septic shock .


Patients were randomized to receive a single dose of calcitriol ( 2 g intravenously ) versus placebo .


The primary outcome was plasma cathelicidin protein levels assessed 24 hours after study drug administration .


Secondary outcomes included leukocyte cathelicidin mRNA expression , plasma cytokine levels ( IL-10 , IL-6 , tumor necrosis factor - , IL-1 , and IL-2 ) , and urinary kidney injury markers .


Patients randomized to calcitriol ( n = 36 ) versus placebo ( n = 31 ) had similar plasma cathelicidin protein levels at 24 hours ( P = 0.16 ) .


Calcitriol-treated patients had higher cathelicidin ( P = 0.04 ) and IL-10 ( P = 0.03 ) mRNA expression than placebo-treated patients 24 hours after study drug administration .


Plasma cytokine levels ( IL-10 , IL-6 , tumor necrosis factor - , IL-1 , and IL-2 ) and urinary kidney injury markers were similar in calcitriol - versus placebo-treated patients ( P > 0.05 for all comparisons ) .


Calcitriol had no effect on clinical outcomes nor were any adverse effects observed .


Calcitriol administration did not increase plasma cathelicidin protein levels in critically ill patients with sepsis and had mixed effects on other immunomodulatory markers .


Additional phase II trials investigating the dose and timing of calcitriol as a therapeutic agent in specific sepsis phenotypes may be warranted .


Clinical trial registered with www.clinicaltrials.gov ( NCT 01689441 ) .


We report active treatment group differences on response and remission rates and changes in anxiety severity at weeks 24 and 36 for the Child/Adolescent Anxiety Multimodal Study ( CAMS ) .


CAMS youth ( N = 488 ; 74 % 12 years of age ) with DSM-IV separation , generalized , or social anxiety disorder were randomized to 12 weeks of cognitive-behavioral therapy ( CBT ) , sertraline ( SRT ) , CBT+SRT ( COMB ) , or medication management/pill placebo ( PBO ) .


Responders attended 6 monthly booster sessions in their assigned treatment arm ; youth in COMB and SRT continued on their medication throughout this period .


Efficacy of COMB , SRT , and CBT ( n = 412 ) was assessed at 24 and 36 weeks postrandomization .


Youth randomized to PBO ( n = 76 ) were offered active CAMS treatment if nonresponsive at week 12 or over follow-up and were not included here .


Independent evaluators blind to study condition assessed anxiety severity , functioning , and treatment response .


Concomitant treatments were allowed but monitored over follow-up .


The majority ( > 80 % ) of acute responders maintained positive response at both weeks 24 and 36 .


Consistent with acute outcomes , COMB maintained advantage over CBT and SRT , which did not differ , on dimensional outcomes ; the 3 treatments did not differ on most categorical outcomes over follow-up .


Compared to COMB and CBT , youth in SRT obtained more concomitant psychosocial treatments , whereas those in SRT and CBT obtained more concomitant combined ( medication plus psychosocial ) treatment .


COMB maintained advantage over CBT and SRT on some measures over follow-up , whereas the 2 monotherapies remained indistinguishable .


The observed convergence of COMB and monotherapy may be related to greater use of concomitant treatment during follow-up among youth receiving the monotherapies , although other explanations are possible .


Although outcomes were variable , most CAMS-treated youth experienced sustained treatment benefit .


Clinical trial registration information-Child and Adolescent Anxiety Disorders ( CAMS ) ; URL : http://clinicaltrials.gov .


Unique identifier : NCT00052078 .


The aim of the study was to compare long-term follow-up results of crush versus culotte stent techniques in coronary bifurcation lesions .


The randomized Nordic Stent Technique Study showed similar 6-month clinical and 8-month angiographic results with the crush and culotte stent techniques of de novo coronary artery bifurcation lesions using sirolimus-eluting stents .


Here , we report the 36-month efficacy and safety of the Nordic Stent Technique Study .


A total of 424 patients with a bifurcation lesion were randomized to stenting of both main vessel and side branch with the crush or the culotte technique and followed for 36 months .


Major adverse cardiac events-the composite of cardiac death , myocardial infarction , stent thrombosis , ortarget vessel revascularization-were the primary endpoint .


Follow-up was complete for all patients .


At 36 months , the rates of the primary endpoint were 20.6 % versus 16.7 % ( p = 0.32 ) , index lesion restenosis 11.5 % versus 6.5 % ( p = 0.09 ) , and definitestent thrombosis 1.4 % versus 4.7 % ( p = 0.09 ) in the crush and the culotte groups , respectively .


At 36-month follow-up , the clinical outcomes were similar for patients with coronary bifurcation lesions treated with the culotte or the crush stent technique .


( Nordic Bifurcation Study .


How to Use Drug Eluting Stents [ DES ] in Bifurcation Lesions ?


NCT00376571 ) .


The incidence of chronic pain is higher among immigrants in Europe than among the native European population .


Therapeutic interventions in this population are far less effective than in patients for whom these programmes were originally developed .


In a randomised trial , we investigated whether a cognitive behavioural treatment ( CBT ) programme supplemented with culturally sensitive aspects ( CsCBT ) improves pain intensity , pain disability and quality of life among immigrant patients , compared with a treatment of culturally sensitive exercise therapy ( CsET ) alone .


Furthermore , we investigated whether healthcare costs would decrease .


First-generation Turkish immigrants residing in Switzerland ( 20-65 years of age ) who suffered from chronic pain were enrolled in the trial .


Patients were randomised to attend either CsCBT or CsET .


The CsCBT intervention was based upon a manualised cognitive-behavioural group treatment programme for chronic pain patients and adapted to the needs of a Turkish immigrant population .


The CsET intervention was based on principles of exercise therapy for treatment of nonspecific low back pain .


A total of 116 outpatients were recruited between October 2004 and November 2006 .


The intervention was completed by 89 patients ( 77 % ) .


A total of 78 subjects ( 67 % ) completed follow-up , 12 months after the completion of the intervention programme .


The intervention showed no effects in reducing pain , pain disability or quality of life .


The analysis of healthcare utilisation yielded no intervention effect .


Cognitive behavioural intervention is feasible with immigrants with chronic disabling pain , but the evidence-based CBT programme , as well as exercise therapy supplemented with culturally sensitive aspects , showed no improvement .


The objectives of this randomized , single-blinded , placebo-controlled pilot trial were to investigate the effects of varenicline on opioid withdrawal among chronic pain patients undergoing opioid detoxification in an interdisciplinary pain program and the feasibility of varenicline use in this population .


Twenty-one patients were recruited ( varenicline = 10 , placebo = 11 ) , and 7 patients in the varenicline and 11 in the placebo group completed the study .


Opioid withdrawal was quantified using the Clinical Opiate Withdrawal Scale , and varenicline-related adverse effects were assessed .


Opioid withdrawal scores tended to decrease over the course of opioid tapering in those receiving varenicline and increase in those receiving placebo .


Varenicline was well-tolerated in this population , with no adverse drug effects ( including nausea ) observed and no effect on improvements in pain severity and depression .


This randomized pilot study provides preliminary data for future trials of varenicline in opioid-dependent adults with chronic pain undergoing medically directed opioid detoxification .


Natural ultraviolet exposure induces hair damage , which is difficult to avoid .


Most of the research work is focused on the effect of ultraviolet on the epidermis , dermis as well as the immune system , whereas the long-term effect of ultraviolet on hair has not been investigated .


we performed our experiment to find out the changes induced in hair follicle and shaft in those patients exposed to high doses of ultraviolet ( A and B ) during treatment of other skin conditions .


Light and transmission electron microscopy examination of scalp hair follicles and shafts of 10 patients with vitiligo under psoralen plus ultraviolet A ( group 1 ) and 10 patients with vitiligo under narrow band ultraviolet B ( group 2 ) was carried out and compared with those of 10 healthy volunteers ( group 3 ) .


Physical changes in the appearance of hair were more in groups 1 and 2 than control .


Reduced hair follicle thickness and perifollicular infiltrate and hyaline disorganized perifollicular collagen were observed more in group 1 than in group 2 with the absence of these changes in group 3 .


Transmission electron microscopy showed nonspecific cell injury in hair follicles in group 1 more than the other 2 groups , while the damaging effect on hair was more in the second group than the others .


Due to the damaging effect of ultraviolet on hair , patients under treatment with this modality should be cautious to protect their hair during treatment .


Kawasaki disease , the most common cause of acquired heart disease in developed countries , is a self-limited vasculitis that is treated with high doses of intravenous immunoglobulin .


Resistance to intravenous immunoglobulin in Kawasaki disease increases the risk of coronary artery aneurysms .


We assessed whether the addition of infliximab to standard therapy ( intravenous immunoglobulin and aspirin ) in acute Kawasaki disease reduces the rate of treatment resistance .


We undertook a phase 3 , randomised , double-blind , placebo-controlled trial in two children 's hospitals in the USA to assess the addition of infliximab ( 5 mg per kg ) to standard therapy .


Eligible participants were children aged 4 weeks-17 years who had a fever ( temperature 380C ) for 3-10 days and met American Heart Association criteria for Kawasaki disease .


Participants were randomly allocated in 1:1 ratio to two treatment groups : infliximab 5 mg/kg at 1 mg/mL intravenously over 2 h or placebo ( normal saline 5 mL/kg , administered intravenously ) .


Randomisation was based on a randomly permuted block design ( block sizes 2 and 4 ) , stratified by age , sex , and centre .


Patients , treating physicians and staff , study team members , and echocardiographers were all masked to treament assignment .


The primary outcome was the difference between the groups in treatment resistance defined as a temperature of 380C or higher at 36 h to 7 days after completion of the infusion of intravenous immunoglobulin .


Analysis was by intention to treat .


This trial is registered with ClinicalTrials.gov , NCT00760435 .


196 patients were enrolled and randomised : 98 to the infliximab group and 98 to placebo .


One patient in the placebo group was withdrawn from the study because of hypotension before receiving treatment .


Treatment resistance rate did not differ significantly ( 11 [ 112 % ] for infliximab and 11 [ 113 % ] for placebo ; p = 081 ) .


Compared with the placebo group , participants given infliximab had fewer days of fever ( median 1 day for infliximab vs 2 days for placebo ; p < 00001 ) .


At week 2 , infliximab-treated patients had greater mean reductions in erythrocyte sedimentation rate ( p = 0009 ) and a two-fold greater decrease in Z score of the left anterior descending artery ( p = 0045 ) than did those in the placebo group , but this difference was not significant at week 5 .


Participants in the infliximab group had a greater mean reduction in C-reactive protein concentration ( p = 00003 ) and in absolute neutrophil count ( p = 0024 ) at 24 h after treatment than did those given placebo , but by week 2 this difference was not significant .


At week 5 , none of the laboratory values differed significantly compared with baseline .


No significant differences were recorded between the two groups at any timepoint in proximal right coronary artery Z scores , age-adjusted haemoglobin values , duration of hospital stay , or any other laboratory markers of inflammation measured .


No reactions to intravenous immunoglobulin infusion occurred in patients treated with infliximab compared with 13 ( 134 % ) patients given placebo ( p < 00001 ) .


No serious adverse events were directly attributable to infliximab infusion .


The addition of infliximab to primary treatment in acute Kawasaki disease did not reduce treatment resistance .


However , it was safe and well tolerated and reduced fever duration , some markers of inflammation , left anterior descending coronary artery Z score , and intravenous immunoglobulin reaction rates .


US Food and Drug Administration , Robert Wood Johnson Foundation , and Janssen Biotech .


To analyze changes in refraction and associated biometric changes in atropine - and placebo-treated eyes in the Atropine for Treatment of Myopia study ( ATOM1 ) .


A total of 400 myopic children , aged 6 to 12 years , were assigned randomly to receive 1 % atropine or a placebo agent in one eye daily for 2 years , after which drops were stopped and children monitored for another year .


Cycloplegic autorefraction , A-scan biometry , and automated keratometry were performed at the initial visit , 2 weeks ( baseline ) , and at 4 , 8 , 12 , 16 , 20 , 24 , 30 , and 36 months .


A total of 313 children ( 78.3 % ) completed the study .


In placebo-treated eyes , there was myopic progression of -1.55 diopters ( D ) , between baseline and 36 months , associated with reductions in corneal curvature ( K ; -0.13 D ) and anterior chamber depth ( ACD ; -0.17 mm ) and increases in lens thickness ( LT ; 0.05 mm ) , vitreous chamber depth ( VCD ; 0.65 mm ) , and axial length ( AL ; 0.53 mm ) .


Multivariate analysis of change in spherical equivalent demonstrated that the hyperopic shift ( 0.20 D ) noted in atropine-treated eyes between baseline and 4 months , and the myopic rebound ( -0.74 D ) noted between 24 to 30 months when atropine was stopped , were associated with a reduction and increase in VCD and AL , respectively , after adjusting for age and sex .


Changes in K , ACD , and LT were less relevant .


Between 4 and 24 months , atropine-treated eyes demonstrated gradual myopic progression ( -0.40 D ) , accompanied by reduction in K ( -0.06 D ) and ACD ( -0.07 mm ) and increase in VCD ( 0.13 mm ) and AL ( 0.06 mm ) .


Atropine appeared to slow myopia progression mainly by reducing or slowing the growth in VCD , and thereby AL. ( ClinicalTrials.gov number , NCT00371124 . )


Sutezolid ( PNU-100480 ) is a linezolid analog with superior bactericidal activity against Mycobacterium tuberculosis in the hollow fiber , whole blood and mouse models .


Like linezolid , it is unaffected by mutations conferring resistance to standard TB drugs .


This study of sutezolid is its first in tuberculosis patients .


Sputum smear positive tuberculosis patients were randomly assigned to sutezolid 600 mg BID ( N = 25 ) or 1200 mg QD ( N = 25 ) , or standard 4-drug therapy ( N = 9 ) for the first 14 days of treatment .


Effects on mycobacterial burden in sputum ( early bactericidal activity or EBA ) were monitored as colony counts on agar and time to positivity in automated liquid culture .


Bactericidal activity was also measured in ex vivo whole blood cultures ( whole blood bactericidal activity or WBA ) inoculated with M. tuberculosis H37Rv .


All patients completed assigned treatments and began subsequent standard TB treatment according to protocol .


The 90 % confidence intervals ( CI ) for bactericidal activity in sputum over the 14 day interval excluded zero for all treatments and both monitoring methods , as did those for cumulative WBA .


There were no treatment-related serious adverse events , premature discontinuations , or dose reductions due to laboratory abnormalities .


There was no effect on the QT interval .


Seven sutezolid-treated patients ( 14 % ) had transient , asymptomatic ALT elevations to 17334 U/L on day 14 that subsequently normalized promptly ; none met Hy 's criteria for serious liver injury .


The mycobactericidal activity of sutezolid 600 mg BID or 1200 mg QD was readily detected in sputum and blood .


Both schedules were generally safe and well tolerated .


Further studies of sutezolid in tuberculosis treatment are warranted .


ClinicalTrials.gov NCT01225640 .


Several planning studies have already proven the substantial dosimetric advantages of RapidArc ( RA ) over standard intensity-modulated radiotherapy .


We retrospectively compared RapidArc and standard sliding window IMRT ( swIMRT ) in locally advanced head and neck cancer , looking both at dosimetrics as well as toxicity and outcome .


CT datasets of 78 patients treated with swIMRT and 79 patients treated with RA were included .


To compare the resulting dose distributions , the dose-volume parameters were evaluated for the planning target volumes ( PTVs ) , clinical target volumes ( CTVs ) , and organs at risk ( OARs ) , and the number of MU were calculated .


Acute toxicity was assessed by the Common Toxicity Criteria version 3.0 .


PTV coverage with the 95 % isodose was slightly better for RA .


Dose distribution has proven to be significantly more homogenous with RA and led to a reduction of 62 % in MU with better OAR sparing .


As for toxicity , more grade 3 mucositis and dysphagia was observed for swIMRT , though we observed more grade 3 dermatitis for RA .


In our retrospective analysis , RA had better target coverage and better sparing of the OAR .


Overall , the grade of acute toxicity was lower for RA than for swIMRT for the same types of tumor locations , except for the grade of dermatitis .


Electrical muscle stimulation ( EMS ) is applied to critically ill patients in order to improve their muscle strength , thereby preventing hypotrophy and promoting functional recovery .


To assess the effects of early EMS on the range of movement of the ankle joint , and on thigh and leg circumference in critically ill patients .


This is a prospective randomized clinical trial comprising 11 patients undergoing mechanical ventilation .


Before and after EMS the thigh and leg circumference in both lower limbs and the goniometry of the tibiotarsal joint were measured .


The angle of 90 on the goniometer was taken as the standard neutral position ( NP ) , with the arm fixed on the lateral malleolus of the ankle joint .


Other measurements , namely dorsiflexion and plantar flexion , referred to as mobile arm , were taken from the NP .


These recordings were obtained following an active contraction of the patients ' muscles .


Compared with the electrostimulated limb , a difference in dorsiflexion of the control limb was observed ( 96.224.9 versus 119.914.1 ; p = 0.01 ) .


A girth of 10cm of the leg was found in limb reduction when compared to the electrostimulated one ( 24.73.1 versus 26.44.0 cm ; p = 0.03 ) .


EMS used at low current intensity and for a short duration failed to prevent muscle atrophy in critically ill patients .


However , we did find a significant improvement in active dorsiflexion of the ankle joint suggesting that it could help to prevent against stance plantar flexion in these patients .


Despite numerous benefits of live donor kidney transplant ( LDKT ) , patient-level barriers often prevent African Americans from considering LDKT .


Educational interventions designed to address patient-level barriers may increase willingness among African American patients with end-stage renal disease to explore LDKT as a treatment option .


To assess the effectiveness of a culturally sensitive educational intervention called Living ACTS ( About Choices in Transplantation and Sharing ) that was designed to address patient-level barriers to LDKT among African American patients with end-stage renal disease .


Patients were randomized to intervention ( n = 136 ) or control ( n = 132 ) groups .


They completed baseline measures and then viewed either the Living ACTS or control video .


Both groups then completed an immediate follow-up measure and a 6-month assessment administered via telephone .


Self-reported knowledge about LDKT , willingness to talk to the patient 's family about LDKT , and perceived benefits of LDKT were measured at 3 time points .


At 6-month follow-up , intervention participants demonstrated a significantly greater increase in knowledge of LDKT than control participants ( F2 ,229 = 3.08 , P = .05 ) .


Intervention participants expressed greater willingness to talk to patients ' families about LDKT than did control participants from baseline through 6-month follow-up ( F1 ,230 = 7.11 , P = .008 ) .


Finally , at immediate follow-up , intervention participants reported greater endorsement of the benefits of LDKT than did control participants ( F2 ,223 = 14.27 , P < .001 ) ; however , this effect had disappeared by the 6-month follow-up .


Living ACTS is effective at increasing and maintaining knowledge about LDKT among African American patients with end-stage renal disease who are considering transplant .


Discharge anticoagulation counseling is important for ensuring patient comprehension and optimizing clinical outcomes .


As pharmacy resources become increasingly limited , the impact of informational videos on the counseling process becomes more relevant .


To evaluate differences in pharmacist time spent counseling and patient comprehension ( measured by the Oral Anticoagulation Knowledge [ OAK ] test ) between informational videos and traditional face-to-face ( oral ) counseling .


This prospective , open , parallel-group study at an academic medical center randomized 40 individuals-17 warfarin-nave ( `` New Start '' ) and 23 with prior warfarin use ( `` Restart '' ) - to receive warfarin discharge education by video or face-to-face counseling .


`` Teach-back '' questions were used in both groups .


Although overall pharmacist time was reduced in the video counseling group ( P < 0.001 ) , an interaction between prior warfarin use and counseling method ( P = 0.012 ) suggests the difference between counseling methods was smaller in New Start participants .


Following adjustment , mean total time was reduced 8.71 ( 95 % CI = 5.15-12 .26 ) minutes ( adjusted P < 0.001 ) in Restart participants and 2.31 ( -2.19 to 6.81 ) minutes ( adjusted P = 0.472 ) in New Start participants receiving video counseling .


Postcounseling OAK test scores did not differ .


Age , gender , socioeconomic status , and years of education were not predictive of total time or OAK test score .


Use of informational videos coupled with teach-back questions significantly reduced pharmacist time spent on anticoagulation counseling without compromising short-term patient comprehension , primarily in patients with prior warfarin use .


Study results demonstrate that video technology provides an efficient method of anticoagulation counseling while achieving similar comprehension .


The postpericardiotomy syndrome ( PPS ) is a common complication following cardiac surgery .


The pathophysiology remains unclear , although evidence exists that surgical trauma and the use of cardiopulmonary bypass provoke an immune response leading to PPS .


We hypothesized that an intraoperative dose of dexamethasone decreases the risk of PPS , by reducing this inflammatory response .


We performed a subanalysis of the DECS study , which is a multicenter , double-blind , placebo-controlled , randomized trial of 4,494 patients undergoing cardiac surgery with use of cardiopulmonary bypass .


The aim of the DECS study was to investigate whether a single intraoperative dose of 1 mg/kg dexamethasone reduced the incidence of a composite of death , myocardial infarction , stroke , renal failure , or respiratory failure , within 30 days of randomization .


In this substudy , we retrospectively analyzed the occurrence of PPS in 822 patients who were included in the DECS trial and underwent valvular surgery .


Postpericardiotomy syndrome was diagnosed if 2 of 5 listed symptoms were present : unexplained fever , pleuritic chest pain , pericardial or pleural rub , new or worsening pericardial or pleural effusion .


All medical charts , x-rays , and echocardiograms were reviewed .


Secondary end point was the occurrence of complicated PPS , defined as PPS with need for evacuation of pleural effusion , pericardiocentesis , and tamponade requiring intervention or hospital readmission for PPS .


This is a blinded , single-center , post hoc analysis .


Postpericardiotomy syndrome occurred in 119 patients ( 14.5 % ) .


The incidence of PPS after dexamethasone compared with placebo was 13.5 % vs 15.5 % ( relative risk 0.88 , 95 % CI 0.63-1 .22 ) .


For complicated PPS , the incidence was 3.8 % versus 3.2 % ( relative risk 1.17 , 95 % CI 0.57-2 .41 , P = .66 ) , respectively .


In patients undergoing valvular cardiac surgery , high-dose dexamethasone treatment had no protective effect on the occurrence of PPS or complicated PPS .


To assess the effect of two selective serotonin reuptake inhibitors ( SSRIs ) , fluvoxamine and citalopram , that markedly differ in their level of cytochrome P450 ( CYP ) 2C19 inhibition , on the laboratory response to clopidogrel , a prodrug requiring metabolism by the CYP system , and especially CYP2C19 , to produce its active form .


Randomized , double-blind , crossover trial .


Clinical research unit of an academic medical center .


Fifteen healthy male volunteers .


All subjects received clopidogrel as a 300-mg loading dose on day 1 , followed by 75mg/day on days 2 and 3 .


Platelet function was tested at baseline and then after clopidogrel treatment on day 3 .


After a washout period of 2weeks , subjects were randomly assigned in a double-blind manner to receive either citalopram 20mg/day or fluvoxamine 100mg/day for 7days .


On day 5 , platelet function was tested while receiving the SSRI treatment alone ; then , a 300-mg clopidogrel loading dose was administered , followed by clopidogrel 75mg/day on days 6 and 7 .


Platelet function was then reassessed on day 7 while receiving the combination of the SSRI and clopidogrel .


The treatment protocol was then repeated after a washout period of 2weeks in all subjects with the other SSRI .


The antiplatelet effects of fluvoxamine and citalopram and their interactions with clopidogrel were assessed .


The response to these three drugs was assessed by light transmittance aggregometry and vasodilator-stimulated phosphoprotein phosphorylation , reporting P2Y12 receptor reactivity .


Both fluvoxamine and citalopram tended to reduce adenosine diphosphate-induced aggregation : 80.83.4 % at baseline , 67.36.3 % while receiving citalopram , and 65.86.4 % while receiving fluvoxamine .


All subjects had a good laboratory response to clopidogrel , with a mean aggregation of 23.53.2 % and a mean platelet reactivity index of 47.73.9 % ( p < 0.001 compared with baseline for both methods ) .


Laboratory response to clopidogrel was significantly attenuated in the presence of fluvoxamine compared with the response in the presence of citalopram as tested both by aggregometry ( 32.34.2 % vs 23.43 % , p = 0.04 ) and by vasodilator-stimulated phosphoprotein phosphorylation ( 52.75.1 % vs 35.94.2 % , p = 0.02 ) .


Fluvoxamine attenuated the laboratory response to clopidogrel , possibly through inhibition of CYP2C19 , whereas citalopram did not affect this response .


These potential drug interactions should be taken into consideration in the selection of the appropriate antidepressant agent for patients who are treated with clopidogrel .


Millions of children worldwide suffer from posttraumatic stress disorder ( PTSD ) symptoms and other mental health problems due to repeated exposure to war or organized violence .


Forms of cognitive-behavioral therapy ( CBT ) are the most commonly used treatment for PTSD and appear to be effective for children as well , but little is known about the mechanisms of change through which they achieve their effectiveness .


Here we present the study protocol of a randomized controlled trial ( RCT ) studying the effectiveness and mechanisms of change of Narrative Exposure Therapy ( NET ) , a CBT-based , manualized , short-term intervention for PTSD symptoms resulting from repeated traumatization , in immigrant children traumatized by war .


We are conducting a multicentre , pragmatic RCT in a usual care setting .


Up to 80 9-17-year-old immigrant children who have experienced war and suffer from PTSD symptoms will be randomized into intervention ( NET ) and control ( treatment as usual , TAU ) groups of equal sizes .


The effectiveness of NET treatment will be compared to both a waiting list and the parallel TAU positive control group , on the primary outcomes of PTSD and depressive symptoms , psychological distress , resilience , and level of cognitive performance .


The effects of the intervention on traumatic memories and posttraumatic cognitions will be studied as potential mechanisms of change mediating overall treatment effectiveness .


The possible moderating effects of peritraumatic dissociation , level of cognitive performance , and gender on treatment effectiveness will also be considered .


We hypothesize that NET will be more effective than a waitlist condition or TAU in reducing PTSD and other symptoms and improving resilience , and that these effects will be mediated by changes in traumatic memories and posttraumatic cognitions .


The results of this trial will provide evidence for the effectiveness of NET in treating trauma-related symptoms in immigrant children affected by war .


The trial will also generate insights into the complex relationships between PTSD , memory functions , posttraumatic cognitions and cognitive performance in children , and help guide the future development and implementation of therapeutic interventions for PTSD in children .


ClinicalTrials.gov NCT02425280 .


Registered 15 April 2015 .


Docosahexaenoic acid ( DHA ) continues to be evaluated and recommended as treatment and prophylaxis for various diseases .


We recently assessed efficacy of high-dose DHA supplementation to slow vision loss in patients with X-linked retinitis pigmentosa ( XLRP ) in a randomized clinical trial .


Because DHA is a highly unsaturated fatty acid , it could serve as a target for free-radical induced oxidation , resulting in increased oxidative stress .


Biosafety was monitored during the 4-year trial to determine whether DHA supplementation was associated with identifiable risks .


Males ( n = 78 ; 7-31 years ) meeting entry criteria were enrolled .


The modified intent-to-treat cohort ( DHA = 33 ; placebo = 27 ) adhered to the protocol 1 year .


Participants were randomized to an oral dose of 30 mg/kg/d DHA or placebo plus a daily multivitamin .


Comprehensive metabolic analyses were assessed for group differences .


Treatment-emergent adverse events including blood chemistry metabolites were recorded .


By year 4 , supplementation elevated plasma and red blood cell-DHA 4.4 - and 3.6-fold , respectively , compared with the placebo group ( P < 0.00001 ) .


Over the trial duration , no significant differences between DHA and placebo groups were found for vitamin A , vitamin E , platelet aggregation , antioxidant activity , lipoprotein cholesterol , or oxidized LDL levels ( all P > 0.14 ) .


Adverse events were transient and not considered severe ( e.g. , gastrointestinal [ GI ] irritability , blood chemistry alterations ) .


One participant was unable to tolerate persistent GI discomfort .


Long-term , high-dose DHA supplementation to patients with XLRP was associated with limited safety risks in this 4-year trial .


Nevertheless , GI symptoms should be monitored in all patients taking high dose DHA especially those with personal or family history of GI disturbances .


( ClinicalTrials.gov number , NCT00100230 . )


A lack of physical activity and overconsumption of energy dense food is associated with overweight and obesity .


The neighbourhood environment may stimulate or hinder the development and/or maintenance of a healthy lifestyle .


To improve research on the obesogenicity of neighbourhood environments , reliable , valid and convenient assessment methods of potential obesogenic characteristics of neighbourhood environments are needed .


This study examines the reliability and validity of the SPOTLIGHT-Virtual Audit Tool ( S-VAT ) , which uses remote sensing techniques ( Street View feature in Google Earth ) for desk-based assessment of environmental obesogenicity .


A total of 128 street segments in four Dutch urban neighbourhoods - heterogeneous in socio-economic status and residential density - were assessed using the S-VAT .


Environmental characteristics were categorised as walking related items , cycling related items , public transport , aesthetics , land use-mix , grocery stores , food outlets and physical activity facilities .


To assess concordance of inter - and intra-observer reliability of the Street View feature in Google Earth , and validity scores with real life audits , percentage agreement and Cohen 's Kappa ( k ) were calculated .


Intra-observer reliability was high and ranged from 91.7 % agreement ( k = 0.654 ) to 100 % agreement ( k = 1.000 ) with an overall agreement of 96.4 % ( k = 0.848 ) .


Inter-observer reliability results ranged from substantial agreement 78.6 % ( k = 0.440 ) to high agreement , 99.2 % ( k = 0.579 ) , with an overall agreement of 91.5 % ( k = 0.595 ) .


Criterion validity was substantial to high for most of the categories ranging from 87.3 % agreement ( k = 0.539 ) to 99.9 % agreement ( k = 0.887 ) with an overall score of 95.6 % agreement ( k = 0.747 ) .


These study results suggest that the S-VAT is a highly reliable and valid remote sensing tool to assess potential obesogenic environmental characteristics .


To describe the prognostic value of three novel biomarkers for acute adverse kidney events compared with routine biological markers .


We used high-end MS to quantify biomarkers predictive of acute kidney injury ( AKI ) and major adverse kidney events ( MAKE ) in 100 adult patients after open heart surgery ( n = 100 ) .


Early postoperatively measured LG3 ( a C-terminal fragment of perlecan ) , LTBP2 ( latent transforming growth factor binding protein-2 ) , Cathepsin L as well as two other renal biomarkers ( NGAL , Cystatin C ) had greater predictive value for AKI ( n = 23 ) and MAKE ( n = 24 ) compared with creatinine , urea and urine output .


LG3 , LTBP2 and Cathepsin L deserve further exploration as biomarkers for the early identification of patients at risk of MAKE .


To investigate the effects of exercise preconditioning on oxidative injury in the intestinal tissue of rats .


Sixty male Wistar rats were randomly divided into six groups as sham ( n = 10 ) , ischemia-reperfusion ( n = 10 ) , exercise ( n = 10 ) , exercise plus ischemia-reperfusion ( n = 10 ) , ischemic preconditioning ( n = 10 ) , and ischemic preconditioning plus ischemia-reperfusion groups ( n = 10 ) .


Tissue levels of malondialdehyde and activities of myeloperoxidase and superoxide dismutase , and serum levels of tumor necrosis factor-alpha and interleukin-6 were measured .


Intestinal tissue histopathology was also evaluated by light microscopy .


Tumor necrosis factor-alpha concentrations significantly decreased in the exercise group compared to the sham group ( p < 0.05 ) .


Myeloperoxidase activity significantly increased and superoxide dismutase activity significantly decreased in ischemia-reperfusion group compared to the sham group ( p < 0.05 ) .


Superoxide dismutase activity in the ischemic preconditioning and ischemic preconditioning plus ischemia-reperfusion groups were significantly higher compared to the ischemia-reperfusion and exercise groups ( p < 0.05 ) .


Histopathologically , intestinal injury significantly attenuated in the exercise plus ischemia-reperfusion group compared to the ischemia-reperfusion group .


The results of the present study indicate that exercise training seems to have a protective role against intestinal ischemia-reperfusion injury ( Tab .


3 , Fig. 1 , Ref .


35 ) .


To observe the sedative and analgesic effects of dexmedetomidine ( Dex ) and its influence on respiration and blood pressure , evaluate electrophysiological monitoring and explore the optimal dose of Dex for brain nuclei lesion in Parkinson 's disease ( PD ) patients .


Approved by hospital ethics committee , 60 PD patients undergoing brain nuclei lesion ablation were randomly allocated into 3 groups ( n = 20 each ) .


No sedative anesthetic was used in group A ; In group B , Dex 0.3 g/kg intravenously for initial bolus ( duration 15 min ) and then 0.3 gkg ( -1 ) h ( -1 ) continuous infusion ; In group C , Dex 0.5 g/kg intravenously ( duration 15 min ) for initial load and then 0.3 gkg ( -1 ) h ( -1 ) continuous infusion .


The parameters of mean arterial pressure ( MAP ) , heart rate ( HR ) , pressure of end-tidal carbon dioxide ( P ETCO2 ) , respiratory rate , blood oxygen saturation ( SpO2 ) , observer 's assessment of alertness/sedation ( OAA/S ) and verbal rating score ( VRS ) were recorded at 0 min ( baseline ) , 5 min ( T1 ) , 10 min ( T2 ) , 15 min ( T3 ) , 20 min ( T4 ) , 30 min ( T5 ) and 60 min ( T6 ) after the dosing of Dex .


HR and respiratory rate decreased in groups B and C compared with baseline .


In group C , P ETCO2 was much higher , compared with baseline ( P < 0.05 ) .


Blood pressures of three groups were well-controlled .


The incidence of pain ( VRS 1 ) in group A was significantly higher than those of groups B and C ( P < 0.05 ) .


And the incidence of sedation ( OAA/S > 1 ) in group C was much higher than those of groups A and B.


The electrophysiological signal of two patients in group C was severely affected .


At an initial intravenous dose of Dex 0.3 g/kg and a maintenance dose of 0.3 g kg ( -1 ) h ( -1 ) , electrophysiological monitoring for surgery is not affected in PD patients undergoing brain nuclei lesion ablation .


With a minimal interference of breath , Dex has not only well-controlled effects on sedation , analgesia and blood pressure , but also makes patients comfortable .


To characterize subgroups of subjects with schizophrenia from the Ziprasidone Observational Study of Cardiac Outcomes ( ZODIAC ) trial who either completed or attempted suicide and those who did not .


The ZODIAC , conducted between February 2002 and March 2007 , was an open-label , randomized , large simple trial of patients with schizophrenia ( N = 18,154 ) followed up for 1 year by unblinded investigators providing usual care in 18 countries ; the primary outcome measure was nonsuicide mortality .


Every report on a completed or attempted suicide was independently adjudicated using a predefined algorithm .


Primary analysis for the current report examined the association between completed or attempted suicides and the baseline variables using descriptive statistics and multivariate logistic regression models .


Usage of `` hard '' or `` soft '' methods for attempted or completed suicide and distribution of suicide-related events by geographical region were also summarized .


Overall incidences of subjects who either completed ( 35/18 ,154 ) or attempted ( 108/18 ,154 ) suicide were low , as were rates per person-time on assigned treatment analysis ( 0.24 for completed and 0.74 for attempted suicides per 100 person-years of exposure ) .


The highest suicide-related mortality was seen among subjects recently diagnosed with schizophrenia .


Among all potential baseline risk factors for completed suicide examined , the variables most associated with completed suicide were history of suicide attempts ( OR = 2.6 ; 95 % CI , 1.33-5 .12 ) and usage of antidepressant medication ( OR = 3.5 ; 95 % CI , 0.84-14 .85 ) .


History of > 5 hospitalizations in the past ( OR = 2.1 ; 95 % CI , 1.35-3 .31 ) and history of suicide attempts ( OR = 5.0 ; 95 % CI , 3.21-7 .76 ) were the variables most associated with attempted suicide among potential baseline risk factors for suicide attempts .


Our results , obtained in a large prospective randomized study , confirm current clinical understanding regarding completed or attempted suicide in schizophrenia and the associated risk factors .


ClinicalTrials.gov identifier : NCT00418171 .


To evaluate the efficacy of a short-term intravenous infusion of levosimendan in patients with heart failure due to acute myocardial infarction ( AMI ) .


This was a randomized , single-center , single-blind study that included 160 patients .


Patients were randomly divided into 2 groups : 1 received levosimendan ( n = 80 ) and the other received placebo ( n = 80 ) .


The study included multiple primary end points ( death , myocardial ischemia or worsening heart at the 6 month follow-up ) and used a composite outcome .


The primary end point rate in the levosimendan group was lower than that in placebo group ( 43.7 vs. 62.5 % , HR 0.636 , 95 % CI 0.413-0 .981 , p = 0.041 ) .


Moreover , the mortality rate at 6 months was similar between the 2 groups ( 17.5 vs. 22.5 % , HR 0.786 , 95 % CI 0.382-1 .543 , p = 0.458 ) .


There was a higher incidence of myocardial ischemia in the levosimendan group at 14 days than in the placebo group ( 11.2 vs. 7.5 % , HR 1.510 , p = 0.435 ) , but between 15 and 180 days , it was significantly lower in the levosimendan group than in the placebo group ( 3.8 vs. 13.8 % , HR 0.261 , p = 0.036 ) .


Short-term intravenous infusion of levosimendan appears to be more effective than placebo for treating patients with heart failure complicated by AMI .


To determine if supervised exercise minimises treatment toxicity in patients with prostate cancer initiating androgen-deprivation therapy ( ADT ) .


This is the first study to date that has investigated the potential role of exercise in preventing ADT toxicity rather than recovering from established toxicities .


Sixty-three men scheduled to receive ADT were randomly assigned to a 3-month supervised exercise programme involving aerobic and resistance exercise sessions commenced within 10 days of their first ADT injection ( 32 men ) or usual care ( 31 men ) .


The primary outcome was body composition ( lean and fat mass ) .


Other study outcomes included bone mineral density , physical function , blood biomarkers of chronic disease risk and bone turnover , general and prostate cancer-specific quality of life , fatigue and psychological distress .


Outcomes were compared between groups using analysis of covariance adjusted for baseline values .


Compared to usual care , a 3-month exercise programme preserved appendicular lean mass ( P = 0.019 ) and prevented gains in whole body fat mass , trunk fat mass and percentage fat with group differences of -1.4 kg ( P = 0.001 ) , -0.9 kg ( P = 0.008 ) and -1.3 % ( P < 0.001 ) , respectively .


Significant between-group differences were also seen favouring the exercise group for cardiovascular fitness ( peak oxygen consumption 1.1 mL/kg/min , P = 0.004 ) , muscular strength ( 4.0-25 .9 kg , P 0.026 ) , lower body function ( -1.1 s , P < 0.001 ) , total cholesterol : high-density lipoprotein-cholesterol ratio ( -0.52 , P = 0.028 ) , sexual function ( 15.2 , P = 0.028 ) , fatigue ( 3.1 , P = 0.042 ) , psychological distress ( -2.2 , P = 0.045 ) , social functioning ( 3.8 , P = 0.015 ) and mental health ( 3.6-3 .8 , P 0.022 ) .


There were no significant group differences for any other outcomes .


Commencing a supervised exercise programme involving aerobic and resistance exercise when initiating ADT significantly reduced treatment toxicity , while improving social functioning and mental health .


Concurrent prescription of supervised exercise when initiating ADT is therefore advised to minimise morbidity associated with severe hypogonadism .


Endoscopic mucosal resection ( EMR ) is simple and quick and has low complication rates .


However , the disadvantage of local recurrence or remnant rate limits the use of this technique .


We aimed to analyse the outcomes of conventional EMR and EMR with circumferential incision ( CIEMR ) , a simplified modification of EMR , in the endoscopic treatment of rectal carcinoid tumours .


A total of 59 consecutive patients with rectal carcinoid tumours without regional lymph node enlargement confirmed by endoscopic ultrasonography were included in the study .


These patients underwent endoscopic treatment from January 2009 to September 2011 and were randomly designated into CIEMR ( n = 31 ) or EMR group ( n = 28 ) .


En bloc resection rate , pathological complete resection rate , procedure time , complications and follow-up outcomes were analysed .


The en bloc resection rate was not significantly different between the CIEMR and EMR groups ( 100 % versus 96.55 % , P > 0.05 ) .


The pathological complete resection rate was higher in the CIEMR group than in the EMR group ( 96.7 % versus 82.14 % , P < 0.05 ) .


The overall complication rate , delayed bleeding and procedure time were not significantly different between the two groups .


No recurrence was observed in either the EMR or CIEMR group .


CIEMR optimises the procedure of EMR and simplifies the technique of endoscopic submucosal dissection ; thus , it has a better histologically complete resection rate and more acceptable complication rate than EMR .


Thus , CIEMR may be preferable to conventional EMR for resection of rectal carcinoid tumours less than 15 mm .


One-quarter of the world 's population will suffer from depression symptoms at some point in their lives .


Mental health services in developed countries are overburdened .


Therefore , cost-effective interventions that provide mental health care solutions such as Web-based psychotherapy programs have been proposed .


The intent of the study was to identify expectations regarding Web-based psychotherapy for the treatment of depression in primary care among patients and health professionals that might facilitate or hinder its effects .


The expectations of untreated patients and health professionals were examined by means of interviews and focus groups .


There were 43 participants ( 20 patients with mild and moderate levels of depression , 11 primary care physicians , and 12 managers ; 22 of them for interviews and 21 for groups ) .


A thematic content analysis from the grounded theory for interviews , and an analysis of the discursive positions of participants based on the sociological model for groups were performed .


Interpretations were achieved by agreement between three independent analysts .


All participants showed a good general acceptance of Web-based psychotherapy , appreciating possible advantages and improvements .


Patients , physicians , and managers shared the same conceptualization of their expectations , although highlighting different aspects .


Patients focused on the need for individualized and personalized interaction , while professionals highlighted the need for the standardization of the program .


Physicians were concerned with extra workload , while managers were worried about optimizing cost-effectiveness .


Expectations of the different participants can conflict with each other .


Finding a balanced position among them is needed if we are to harmoniously implement effective Web-based interventions for depression in routine clinical practice .


EORTC trial 22921 examined the addition of preoperative or postoperative chemotherapy to preoperative radiotherapy in patients with rectal cancer .


After a median follow-up of 5 years , chemotherapy-irrespective of timing-significantly improved local control .


Adjuvant chemotherapy did not improve survival , but the Kaplan-Meier curves diverged , suggesting possible delayed benefit .


Here , we report the updated long-term results .


We randomly assigned patients with clinical stage T3 or T4 resectable rectal cancer to receive preoperative radiotherapy with or without concomitant chemotherapy before surgery followed by either adjuvant chemotherapy or surveillance .


Randomisation was done using minimisation with factors of institution , sex , T stage , and distance from the tumour to the anal verge .


Study coordinators , clinicians , and patients were aware of assignment .


Radiotherapy consisted of 45 Gy to the posterior pelvis in 25 fractions of 18 Gy over 5 weeks .


Each course of chemotherapy consisted of fluorouracil ( 350 mg/m ( 2 ) per day intravenous bolus ) and folinic acid ( leucovorin ; 20 mg/m ( 2 ) per day intravenous bolus ) .


For preoperative chemotherapy , two courses were given ( during weeks 1 and 5 of radiotherapy ) .


Adjuvant chemotherapy was given in four cycles , every 3 weeks .


The primary endpoint was overall survival .


This analysis was done by intention to treat .


The trial is registered with ClinicalTrials.gov , number NCT00002523 .


1011 patients were randomly assigned to treatment between April , 1993 , and March , 2003 ( 252 to preoperative radiotherapy and 253 to each of the other three groups ) .


After a median follow-up of 104 years ( IQR 78-131 ) , 10-year overall survival was 494 % ( 95 % CI 446-541 ) for the preoperative radiotherapy group and 507 % ( 459-552 ) for the preoperative radiotherapy and chemotherapy group ( HR 099 , 95 % CI 083-118 ; p = 091 ) .


10-year overall survival was 518 % ( 95 % CI 470-564 ) for the adjuvant chemotherapy group and 484 % ( 436-530 ) for the surveillance group ( HR 091 , 95 % CI 077-109 , p = 032 ) .


10-year disease-free survival was 442 % ( 95 % CI 395-488 ) for the preoperative radiotherapy group and 464 % ( 417-509 ) for the preoperative radiotherapy and chemotherapy group ( HR 093 , 95 % CI 079-110 ; p = 038 ) .


10-year disease-free survival was 470 % ( 95 % CI 422-516 ) for the adjuvant chemotherapy group and 437 % ( 391-482 ) for the surveillance group ( HR 091 , 95 % CI 077-108 , p = 029 ) .


At 10 years , cumulative incidence of local relapse was 224 % ( 95 % CI 171-276 ) with radiotherapy alone , 118 % ( 78-158 ) with neoadjuvant radiotherapy and chemotherapy , 145 % ( 101-189 ) with radiotherapy and adjuvant chemotherapy and 117 % ( 77-156 ) with both adjuvant and neoadjuvant chemotherapy ( p = 00017 ) .


There was no difference in cumulative incidence of distant metastases ( p = 052 ) .


The frequency of long-term side-effects did not differ between the four groups ( p = 022 ) .


Adjuvant fluorouracil-based chemotherapy after preoperative radiotherapy ( with or without chemotherapy ) does not affect disease-free survival or overall survival .


Our trial does not support the current practice of adjuvant chemotherapy after preoperative radiotherapy with or without chemotherapy .


New treatment strategies incorporating neoadjuvant chemotherapy are required .


EORTC , US National Cancer Institute , Programme Hospitalier de Recherche Clinique , Ligue contre le Cancer Comit du Doubs .


A variety of techniques exist for the treatment of patients with great saphenous vein ( GSV ) varicosities .


Few data exist on the long-term outcomes of these interventions .


Patients undergoing conventional surgery , endovenous laser ablation ( EVLA ) and ultrasound-guided foam sclerotherapy ( UGFS ) for GSV varicose veins were followed up for 5 years .


Primary outcome was obliteration or absence of the treated GSV segment ; secondary outcomes were absence of GSV reflux , and change in Chronic Venous Insufficiency quality-of-life Questionnaire ( CIVIQ ) and EuroQol - 5D ( EQ-5D ) scores .


A total of 224 legs were included ( 69 conventional surgery , 78 EVLA , 77 UGFS ) , 193 ( 86.2 per cent ) of which were evaluated at final follow-up .


At 5 years , Kaplan-Meier estimates of obliteration or absence of the GSV were 85 ( 95 per cent c.i. 75 to 92 ) , 77 ( 66 to 86 ) and 23 ( 14 to 33 ) per cent in the conventional surgery , EVLA and UGFS groups respectively .


Absence of above-knee GSV reflux was found in 85 ( 73 to 92 ) , 82 ( 72 to 90 ) and 41 ( 30 to 53 ) per cent respectively .


CIVIQ scores deteriorated over time in patients in the UGFS group ( 0.98 increase per year , 95 per cent c.i. 0.16 to 1.79 ) , and were significantly worse than those in the EVLA group ( -0.44 decrease per year , 95 per cent c.i. -1.22 to 0.35 ) ( P = 0.013 ) .


CIVIQ scores for the conventional surgery group did not differ from those in the EVLA and UGFS groups ( 0.44 increase per year , 95 per cent c.i. -0.41 to 1.29 ) .


EQ-5D scores improved equally in all groups .


EVLA and conventional surgery were more effective than UGFS in obliterating the GSV 5 years after intervention .


UGFS was associated with substantial rates of GSV reflux and inferior CIVIQ scores compared with EVLA and conventional surgery .


NCT00529672 ( http://www.clinicaltrials.gov ) .


Chemotherapy-induced peripheral neuropathy ( CIPN ) occurs in as high as 70 % of patients receiving certain types of chemotherapy agents .


The FDA has yet to approve a therapy for CIPN .


The aim of this multicenter , phase III , randomized , double-blind , placebo-controlled trial was to investigate the efficacy of 2 % ketamine plus 4 % amitriptyline ( KA ) cream for reducing CIPN .


Cancer survivors who completed chemotherapy at least 1 month prior and had CIPN ( > 4 out of 10 ) were enrolled ( N = 462 ) .


CIPN was assessed using average scores from a 7-day daily diary that asks patients to rate the average `` pain , numbness , or tingling in [ their ] hands and feet over the past 24 h '' on an 11-point numeric rating scale at baseline and 6 weeks post intervention .


ANCOVA was used to measure differences in 6-week CIPN with effects including baseline CIPN , KA treatment arm , and previous taxane therapy ( Y/N ) .


The KA treatment showed no effect on 6-week CIPN scores ( adjusted mean difference = -0.17 , p = 0.363 ) .


This study suggests that KA cream does not decrease CIPN symptoms in cancer survivors .


This study investigated the long-term safety of rivastigmine ( 12 mg/d capsules , 9.5 mg/24 h patch ) and effects on motor symptoms in patients with mild-to-moderately severe Parkinson disease dementia .


This was a 76-week , prospective , open-label , randomized study in patients aged 50 to 85 years .


Primary outcomes included incidence of , and discontinuation due to , predefined adverse events ( AEs ) potentially arising from worsening of Parkinson disease motor symptoms with capsules .


Secondary outcomes included frequency of AEs/serious AEs .


Efficacy outcomes included Alzheimer 's Disease Cooperative Study-Activities of Daily Living ( ADCS-ADL ) , Neuropsychiatric Inventory ( NPI-10 ) , and Mattis Dementia Rating Scale ( MDRS ) .


Five hundred eighty-three patients were randomized to rivastigmine capsules ( n = 295 ) or patch ( n = 288 ) .


Incidence of predefined AEs was 36.1 % for capsules , 31.9 % for patch ; discontinuation due to worsening of motor symptoms was 4.4 % and 2.4 % , respectively .


Most common AEs were nausea ( capsules , 40.5 % ; patch , 8.3 % ) , tremor ( 24.5 % ; 9.7 % ) , fall ( 17.0 % ; 20.1 % ) , vomiting ( 15.3 % ; 2.8 % ) , and application site erythema ( 0 % ; 13.9 % ) .


Significant efficacy in favor of capsules was observed at weeks 24 to 76 on MDRS ; 24 and 76 on NPI-10 ; weeks 52 and 76 on ADCS-ADL .


In patients with Mini-Mental State Examination ( MMSE ) greater than 21 , no differences in efficacy on MDRS and ADCS-ADL were observed at any time point ; significant differences in favor of capsules were maintained in patients with MMSE less than or equal to 21 .


This study supports the long-term safety of rivastigmine in Parkinson disease dementia .


The rate of worsening of motor symptoms was in the range expected due to the natural progression of Parkinson disease , no new or unexpected safety issues emerged in the long-term .


This study delineates activities of daily living ( ADL ) and instrumental activities of daily living ( IADL ) black-white disparity trends by age , period , and cohort ( APC ) and explores sociodemographic contributors of cohort-based disparity trends .


We utilized multiple cross-sectional waves of National Health Interview Survey data ( 1982-2009 ) to describe APC trends of ADL and IADL disparities using a cross-classified random effect model .


Further , we decomposed the cohort-based disparity trends using Fairlie 's decomposition method for nonlinear outcomes .


The crossover ADL and IADL disparities ( whites > blacks ) occurring at age 75 increased with age and reached a plateau at age of 80 , whereas period-based ADL and IADL disparities remained constant for the past 3 decades .


The cohort disparity trends for both disabilities showed a decline with each successive cohort except for ADL disparity among women .


We examined the role of aging on racial disparity in disability and found support for the racial crossover effect .


Further , the racial disparity in disability will disappear should the observed pattern of declining cohort-based ADL and IADL disparities persist .