In this blinded , double-dummy , parallel group , 12-week study , patients with moderate-to-severe COPD were randomized 1:1 to glycopyrronium 50 g once daily or tiotropium 18 g once daily .


The primary objective was to demonstrate the non-inferiority of glycopyrronium versus blinded tiotropium with respect to trough forced expiratory volume in 1 second ( FEV1 ) following 12 weeks of treatment ( non-inferiority margin : -50 mL ) .


Secondary objectives were to evaluate glycopyrronium versus tiotropium for other spirometric outcomes , breathlessness ( Transition Dyspnea Index ; TDI ) , health status ( St George 's Respiratory Questionnaire ; SGRQ ) , daily rescue medication use , COPD exacerbations and COPD symptoms over 12 weeks of treatment .


657 patients were randomized ( glycopyrronium : 327 ; tiotropium : 330 ) ; 96 % ( 630 patients ) completed the study .


Least squares mean trough FEV1 for both glycopyrronium and tiotropium was 1.405 L at Week 12 , meeting the criterion for non-inferiority ( mean treatment difference : 0 mL , 95 % CI : -32 , 31 mL ) .


Glycopyrronium demonstrated rapid bronchodilation following first dose on Day 1 , with significantly higher FEV1 at all time points from 0-4 h post-dose versus tiotropium ( all p < 0.001 ) .


FEV1 area under the curve from 0-4 h ( AUC0-4h ) post-dose with glycopyrronium was significantly superior to tiotropium on Day 1 ( p < 0.001 ) and was comparable to tiotropium at Week 12 .


Glycopyrronium demonstrated comparable improvements to tiotropium in TDI focal score , SGRQ total score , rescue medication use and the rate of COPD exacerbations ( all p = not significant ) .


Patients on glycopyrronium also had a significantly lower total COPD symptom score versus patients on tiotropium after 12 weeks ( p = 0.035 ) .


Adverse events were reported by a similar percentage of patients receiving glycopyrronium ( 40.4 % ) and tiotropium ( 40.6 % ) .


In patients with moderate-to-severe COPD , 12-week blinded treatment with once-daily glycopyrronium 50 g or tiotropium 18 g , provided similar efficacy and safety , with glycopyrronium having a faster onset of action on Day 1 versus tiotropium .


To investigate the potential of lipoprotein-associated phospholipase A2 inhibition as a novel mechanism to reduce edema and improve vision in center-involved diabetic macular edema ( DME ) .


Prospective , multicenter , randomized , double-masked , placebo-controlled phase IIa study .


Fifty-four center-involved DME patients randomized 2:1 to receive darapladib ( n = 36 ) or placebo ( n = 18 ) .


Darapladib 160 mg or placebo monotherapy was administered orally once daily for 3 months , and patients were followed up monthly for 4 months .


Mean change from baseline in best-corrected visual acuity ( BCVA ) and the center subfield and center point of the study eye at month 3 as determined by spectral-domain optical coherence tomography .


Five patients in the study received intravitreal anti-vascular endothelial growth factor rescue therapy before the day 90 assessment , 2 of 36 ( 6 % ) in the darapladib arm and 3 of 18 ( 17 % ) in the placebo arm .


Administration of 160 mg darapladib for 3 months resulted in statistically significant mean improvements , from baseline to month 3 , in BCVA of 4.1 Early Treatment Diabetic Retinopathy Study ( ETDRS ) letters ( 95 % confidence interval [ CI ] , 2.3-5 .8 ) and of 57 m in central subfield thickness ( 95 % CI , -84 to -30 ) in the study eyes .


An increase in BCVA of 1.7 ETDRS letters ( 95 % CI , -1.0 to 4.4 ) and a decrease in center subfield thickness of 34 m ( 95 % CI , -75 to 6.8 ) for the placebo group were not significant .


No ocular severe adverse events ( SAEs ) or SAEs considered related to darapladib were reported .


One SAE of myocardial infarction , not considered related to darapladib , was reported , and 1 SAE of severe diarrhea was reported in a placebo patient , subsequently withdrawn from the study .


Study eye ocular adverse events ( AEs ) and nonocular AEs were similar between treatment groups .


Once-daily oral darapladib administered for 3 months demonstrated modest improvements in vision and macular edema that warrant additional investigation of this novel lipoprotein-associated phospholipase A2 inhibitory mechanism for the treatment of DME .


To characterize retinal metabolism during normoxia and hyperoxia in healthy subjects .


Forty-six healthy subjects were included in the present study , and data of 41 subjects could be evaluated .


Retinal vessel diameters , as well as oxygen saturation in arteries and veins , were measured using the Dynamic Vessel Analyzer .


In addition , retinal venous blood velocity was measured using bidirectional laser Doppler velocimetry , retinal blood flow was calculated , and oxygen and carbon dioxide partial pressures were measured from arterialized capillary blood from the earlobe .


Measurements were done during normoxia and during 100 % oxygen breathing .


Systemic hyperoxia caused a significant decrease in retinal venous diameter ( -13.0 % 4.5 % ) and arterial diameter ( -12.1 % 4.0 % ) , in retinal blood velocity ( -43.4 % 7.7 % ) , and in retinal blood flow ( -57.0 % 5.7 % ) ( P < 0.001 for all ) .


Oxygen saturation increased in retinal arteries ( +4.4 % 2.3 % ) and in retinal veins ( +19.6 % 6.2 % ) , but the arteriovenous oxygen content difference significantly decreased ( -29.4 % 19.5 % ) ( P < 0.001 for all ) .


Blood oxygen tension in arterialized blood showed a pronounced increase from 90.2 7.7 to 371.3 92.7 mm Hg ( P < 0.001 ) .


Calculated oxygen extraction in the eye decreased by as much as 62.5 % 9.5 % ( P < 0.001 ) .


Our data are compatible with the hypothesis that during 100 % oxygen breathing a large amount of oxygen , consumed by the inner retina , comes from the choroid , which is supported by previous animal data .


Interpretation of oxygen saturation data in retinal arteries and veins without quantifying blood flow is difficult .


( ClinicalTrials.gov number , NCT01692821 . )


Young people in sub-Saharan Africa are affected by the HIV pandemic to a greater extent than young people elsewhere and effective HIV-preventive intervention programmes are urgently needed .


The present article presents the rationale behind an EU-funded research project ( PREPARE ) examining effects of community-based ( school delivered ) interventions conducted in four sites in sub-Saharan Africa .


One intervention focuses on changing beliefs and cognitions related to sexual practices ( Mankweng , Limpopo , South Africa ) .


Another promotes improved parent-offspring communication on sexuality ( Kampala , Uganda ) .


Two further interventions are more comprehensive aiming to promote healthy sexual practices .


One of these ( Western Cape , South Africa ) also aims to reduce intimate partner violence while the other ( Dar es Salaam , Tanzania ) utilises school-based peer education .


A modified Intervention Mapping approach is used to develop all programmes .


Cluster randomised controlled trials of programmes delivered to school students aged 12-14 will be conducted in each study site .


Schools will be randomly allocated ( after matching or stratification ) to intervention and delayed intervention arms .


Baseline surveys at each site are followed by interventions and then by one ( Kampala and Limpopo ) or two ( Western Cape and Dar es Salaam ) post-intervention data collections .


Questionnaires include questions common for all sites and are partly based on a set of social cognition models previously applied to the study of HIV-preventive behaviours .


Data from all sites will be merged in order to compare prevalence and associations across sites on core variables .


Power is set to .80 or higher and significance level to .05 or lower in order to detect intervention effects .


Intraclass correlations will be estimated from previous surveys carried out at each site .


We expect PREPARE interventions to have an impact on hypothesized determinants of risky sexual behaviour and in Western Cape and Dar es Salaam to change sexual practices .


Results from PREPARE will ( i ) identify modifiable cognitions and social processes related to risky sexual behaviour and ( ii ) identify promising intervention approaches among young adolescents in sub-Saharan cultures and contexts .


Controlled Trials ISRCTN56270821 ( Cape Town ) ; Controlled Trials ISRCTN10386599 ( Limpopo ) ; Clinical Trials NCT01772628 ( Kampala ) ; Australian New Zealand Clinical Trials Registry ACTRN12613000900718 ( Dar es Salaam ) .


Though topical corticosteroids ( TC ) are used for treating atopic dermatitis ( AD ) as a standard , there exist several problems including topical steroid addiction ( TSA ) or Red skin syndrome .


Moreover , the number of patients , who refrain from using TC because of steroid-phobia , is increasing .


Recently , topical PPAR alpha ligand application has been reported to improve experimental allergic dermatitis .


The purpose of this study was to investigate the short-term efficacy and safety of topical clofibrate , one of PPAR alpha ligand , in such steroid-phobic patients with AD .


This study was conducted as a double-blind design to investigate the effects of random administration of topical clofibrate and base ( placebo ) on skin manifestation and blood parameters of patients for 2 weeks .


Severity was digitized using severity scoring systems for atopic dermatitis by the Japanese Dermatological Association ( SSS-JDA ) before and after two weeks .


Subjective severity of patients was evaluated using visual analog scale ( Pt-VAS ) .


Serum thymus and activation-regulated chemokine ( TARC ) and immunoglobulin E ( IgE ) were also investigated .


Twenty patients were enrolled , and 19 of 20 patients completed the study .


In 19 patients , the value of severity score using SSS-JDA was decreased significantly after administration of topical clofibrate ( P = 0.001 ) .


Subjective evaluation using Pt-VAS ( P = 0.008 ) and serum TARC levels ( P = 0.03 ) were also significantly decreased after two weeks of topical clofibrate .


There was not a significant difference in serum IgE levels .


No adverse effect was observed .


Topical clofibrate is useful for patients with AD especially who are reluctant to use topical steroids .


To evaluate the effects of single doses of gabapentin 250 and 500 mg on polysomnographic ( PSG ) and participant-reported sleep measures in a 5-h phase advance insomnia model .


Adults reporting occasional disturbed sleep received gabapentin 500 mg ( n = 125 ) , 250 mg ( n = 125 ) , or placebo ( n = 127 ) 30 min prior to bedtime and were in bed from 17:00 to 01:00 , 5 h before their habitual bedtime .


Sleep was assessed by PSG , post-sleep questionnaire , and the Karolinska Sleep Diary ( KSD ) .


Next-day residual effects ( Digit Symbol Substitution Test [ DSST ] and Stanford Sleepiness Scale [ SSS ] ) and tolerability were assessed .


Demographics were comparable among groups .


Among PSG endpoints , wake after sleep onset ( primary endpoint ) ( 135.7 [ placebo ] , 100.7 [ 250 mg ] , and 73.2 [ 500 mg ] min ) was significantly lower and total sleep time ( TST ) ( 311.4 , 356.5 , and 378.7 min ) significantly greater in both gabapentin groups versus placebo .


Latency to persistent sleep was not significantly different among groups .


Percent slow wave sleep ( 12.6 % , 15.4 % , and 17.0 % , respectively ) was significantly greater and percent stage 1 ( 15.1 % , 11.8 % , and 10.8 % , respectively ) significantly lower relative to placebo .


Gabapentin was associated with significantly higher values of KSD Sleep Quality Index and reported TST versus placebo ; no other reported outcomes were significant .


Neither gabapentin dose produced evidence of next-day residual effects as measured by DSST and SSS .


Adverse events were infrequent ( < 5 % ) .


Participants with occasional disturbed sleep treated with gabapentin showed significantly longer sleep duration and greater depth ( versus placebo ) in response to a phase advance manipulation known to disrupt sleep maintenance .


The aim of this study is to evaluate the clinical efficacy of short-term psychodynamic psychotherapy ( STPP ) in comparison with treatment as usual ( TAU ) in treatment of patients suffering from anxiety and depressive disorders .


Sixty patients were recruited from the Psychotherapy Service , University of Milan , Department of Psychiatry , at Milan 's IRCCS Foundation Ca ' Granda , Ospedale Maggiore Policlinico with the diagnosis of depressive or anxiety disorders according to DSM-IV-TR criteria .


These subjects were randomly assigned in a 1:1 ratio to an intervention group ( STPP ) or control group ( TAU ) for 12 months ( T1 ) .


Each patient was clinically evaluated at the moment of recruitment ( T0 ) and after 12 months using a battery composed of these scales : Clinical Global Impression Scale ( CGI ) , Symptom Checklist-90-Revised ( SCL-90-R ) , Inventory of Interpersonal Problems ( IIP ) .


Statistical analysis highlighted significant improvements ( p < 0.05 ) for the group treated with STPP in every clinical scale .


Instead control group revealed significant changes ( p < 0.05 ) only for SCL-90 scale scores .


We noticed a clinical improvement in both groups without particular differences , but the IIP scores went through a significant higher enhancement only in STPP group .


Our results suggest that STPP is so effective as TAU in treatment of anxiety and depressive disorders .


Moreover STPP leads to a better recover of relational functioning .


Carotid artery stenting ( CAS ) is a worldwide diffuse intervention , but may be associated with distal plaque component embolization , and sometimes major and minor stroke .


Statin use has been demonstrated to reduce atherosclerotic plaque burden , but its effect in reducing distal embolization during carotid stenting has not yet been well validated .


With the Rosuvastatin Pretreatment to Reduce Embolization during Carotid Artery Stenting trial , we aim to discover if a pretreatement with high doses of rosuvastatin in dyslipidemic patients is able to reduce periprocedural cerebral ischemic complications following carotid stenting .


This is a phase III prospective , randomized controlled trial .


All consecutive patients with asymptomatic carotid stenosis at least 80 % will be randomized to a 6-week rosuvastatin treatment followed by carotid stenting , and to direct carotid stenting .


Carotid stenting will be performed following common practice with distal or proximal embolic protection .


The primary efficacy end point of the trial will be the prevalence of ` relevant ' embolization during CAS , as a surrogate end point for cerebral ischemic complications .


Other laboratory and clinical data will be registered and patients will be followed up to 1 year .


In order to obtain the expected superiority of statin pretreatment on primary end point , a population of 130 patients will be enrolled into the study .


In conclusion , with the Rosuvastatin Pretreatment to Reduce Embolization during Carotid Artery Stenting trial , we want to evaluate whether a high dose of rosuvastatin for 6 weeks before CAS in asymptomatic patients with severe carotid stenosis is able to reduce the rate of plaque embolization during the procedure , thus suggesting a possible reduction in cerebral ischemic complications .


Among the various factors influencing the success rate , onset time , and duration of peripheral nerve blocks , the role of local anesthetics concentration remains uncertain .


In this prospective , randomized , single-blinded study , we evaluated whether varying the dilution of a fixed dose of mepivacaine solution influenced onset time and duration of sciatic nerve block .


Ninety ASA physical status I to II patients scheduled for foot surgery were randomly allocated to receive a double-injection Labat sciatic nerve block with 12 mL mepivacaine 2 % ( group concentration I = 45 patients ) or 24 mL of mepivacaine 1 % ( group volume II = 45 patients ) .


The nerve stimulator was initially set at 2 Hz , 0.1 millisecond , 1 mA .


The total amount of local anesthetic ( 240 mg ) was kept constant and equally divided between the peroneal and tibial nerves .


All patients also received an ultrasound-guided popliteal sciatic nerve catheter for postoperative analgesia .


Times to readiness for surgery , performance , and offset of local anesthetic were recorded .


Our primary end point was to determine a possible difference in offset time between groups .


Continuous variables were expressed as median ( IQR ) and compared with the Wilcoxon-Mann-Whitney U test ; WMWodds are reported together with their 95 % confidence interval .


The overall success rate of sciatic nerve block was 99 % .


Time of performance was shorter in group I , 120 seconds ( 90-150 seconds ) , than that in group II , 150 seconds ( 120-180 seconds ) ( P = 0.0048 ; WMWodds 2.26 [ 1.35-4 .34 ] ) .


The onset time of sensory and motor sciatic nerve block was 4 minutes ( 2-9 minutes ) in group I and 6 minutes ( 4-10 minutes ) in group II ( P = 0.41 ; WMWodds 1.21 [ 0.77-1 .95 ] ) , while the duration of sensory block was 235 minutes ( 203-250 minutes ) in group I , and 240 minutes ( 218-247 minutes ) in group II respectively ( P = 0.51 ; WMWodds 1.20 [ 0.69-2 .16 ] ) .


We found no evidence that varying volume and concentration while maintaining a fixed total dose of mepivacaine alters the onset time and duration of double-injection sciatic nerve block .


Considering our WMWodds results , possible differences in onset time and duration comparable to differences in the performance time between groups can not be excluded .


To investigate the effects of Thai traditional massage ( TTM ) on pressure pain threshold ( PPT ) and headache intensity in patients with chronic tension-type and migraine headaches .


Randomized controlled trial of TTM compared with the sham ultrasound ( nine sessions each ) during a 3-week period .


Seventy-two participants who had had a headache diagnosis for at least 3 months before the experiment was recruited .


After the treatment and at 3 and 9 weeks of follow-up , the TTM group showed a significant increase in PPT ( p < 0.01 ) compared with the sham ultrasound group .


PPT values at baseline , after 3 weeks of treatment , and at 3 - and 9-week follow-up for the TTM group were 2.71 1.22 , 3.57 1.41 , 3.72 1.46 , and 3.42 1.46 pounds/cm ( 2 ) , respectively ; values in the sham ultrasound group were 2.85 1.20 , 2.62 1.07 , 2.58 1.05 and 2.63 0.94 pounds/cm ( 2 ) .


In both groups , headache intensity decreased significantly ( p < 0.05 ) at every end point of the outcome measures , and there were no differences between the groups ( p > 0.05 ) .


TTM could increase PPT and reduce headache intensity , suggesting that this is a possible alternative treatment for chronic headaches .


To evaluate the usefulness of capnography for early detection of respiratory depression during sedoanalgesia procedures in the pediatric emergency department .


To assess whether the administration of oxygen during the procedure can modify monitored parameters , thus delaying detection of respiratory depression .


A prospective randomized study was performed on children between 1 year and 16 years who underwent sedoanalgesia to perform diagnostic or therapeutic procedures .


They were randomized into two groups ( with or without supplemental oxygen ) .


All patients were monitored by visual inspection , pulse-oximetry and non-invasive capnography .


Monitoring was initiated prior to drug administration and continued until complete recovery of baseline .


The main study variable was respiratory depression defined as apnea , hypoventilation or oxygen desaturation .


Twenty patients were included .


Eleven patients were randomized in the supplemental oxygen group .


This study showed a statistically significant elevation of EtCO2 levels at 5 , 10 and 15min , compared with baseline .


No significant change in the SatO2 mean was detected .


No statistically significant differences were identified when comparing etCO2 mean and SatO2 mean in both groups .


Two cases of respiratory depression were detected early by capnography .


There was a statistically significant correlation between etCO2 at 5 and 10min , and the degree of sedation achieved .


The inclusion of capnography to routine monitoring for adequate sedation procedures could improve safety .


Oxygen administration does not appear to modify the parameters monitored .


Glycemic index and glycemic load are used to facilitate glucose control among adults with type 2 diabetes , with a low glycemic index diet associated with improved glycemic control .


To examine long-term longitudinal associations between changes in glycemic index and glycemic load with glycemic and metabolic control among Latino adults with diabetes .


Secondary data from intervention and comparison participants in the Latinos en Control trial ( 2006 to 2008 ) were analyzed .


Data on dietary intake and metabolic characteristics were from low-income , Latino adults ( N = 238 ; 87.7 % Puerto Rican ) with type 2 diabetes .


The Latinos en Control trial was a randomized clinical trial targeting diabetes self-management among Latinos with type 2 diabetes .


Participants were randomized to a group-based behavioral intervention or usual care and followed through 12 months .


Outcomes included hemoglobin A1c ( HbA1c ) levels , fasting blood glucose , lipid profiles , anthropometrics , and blood pressure .


Glycemic index and load were analyzed using data from three 24-hour dietary recalls conducted at baseline , 4 months , and 12 months .


Repeated measures regression models were used to examine change in glycemic index and load associated with metabolic characteristics at 12 months .


Covariates included sex , age , body mass index , blood pressure , total energy intake , medication use and intensity , physical activity , intervention status ( intervention vs usual care ) , and time .


Increases in glycemic index from baseline to 12 months were associated with increased logarithm of HbA1c levels ( = 0.003 ; P = 0.034 ) and waist circumference ( = 0.12 ; P = 0.026 ) over time , but not with fasting glucose , blood lipids , or body mass index .


There was modest evidence to support small , positive associations between glycemic load and HbA1c levels and waist circumference .


Lowering glycemic index is associated with improvements in certain metabolic risk factors among Latinos with diabetes .


Targeting glycemic index may be an important component of dietary strategies for diabetes self-management .


To test whether communicating cardiovascular diseases ( CVD ) risk using a novel risk assessment tool ( Heart Age ) will be able to motivate a population to adopt healthier lifestyles and improve CVD risk profile over the use of a traditional percentage-based tool .


A single-blind randomized intervention study was carried out in a Caucasian population .


A total of 3153 subjects were randomly allocated to one of three study groups : control ( conventional medical advice was given to the subjects ) , Framingham REGICOR ( 10-year percentage risk score , calibrated to Spanish population was given to the subjects ) , or Heart Age group ( Heart Age tool was administered to the subjects ) .


Anthropometrical and metabolic parameters were measured and lifestyle habits were recorded at recruitment and 12-months post intervention .


Both the Framingham REGICOR and the Heart Age intervention groups demonstrated significant decreases in their risk scores at post intervention compared to the control group , with the improvement being of a greater magnitude in the Heart Age group .


No differences per gender were observed in the Heart Age group .


Informing patients about their CVD risk expressed as the new Heart Age tool results in a reduction in their CVD risk higher than the one observed when the Framingham REGICOR risk score was used .


Tonsillectomy is one of the most common pediatric surgical procedures performed in the United States .


The postoperative period can be particularly painful , and there is currently no consensus on an optimal analgesic regimen .


The objective of this study was to evaluate efficacy and safety of the single drug tramadol versus codeine/acetaminophen post-tonsillectomy .


Prospective , double-blinded , randomized controlled trial .


Large , Midwestern US pediatric hospital .


Eighty-four children aged 4-15 years who underwent a tonsillectomy ( with or without adenoidectomy ) procedure were randomized and 74 were included in the analysis .


Group 1 received liquid codeine/acetaminophen for 10 days post-tonsillectomy ( 5 days scheduled , followed by 5 days as-needed ) .


Group 2 received liquid tramadol for 10 days post-tonsillectomy ( 5 days scheduled , followed by 5 days as-needed ) .


Efficacy and side effects were evaluated using a 10-day take-home diary that was completed by parents .


Children in both study arms reported adequate post-tonsillectomy pain management without significant differences between groups in pain scores .


Oversedation was significantly higher on the day of surgery in the codeine/acetaminophen group , and itching was experienced by significantly more children in the tramadol group during the postoperative period .


As part of multimodal analgesia , scheduled plus as-needed tramadol may be considered for children in the postoperative setting due to its analgesic properties , low potential for side effects , and good safety profile .


Thirty-six months of isoniazid preventive therapy ( 36IPT ) was superior to 6 months of IPT ( 6IPT ) in preventing tuberculosis ( TB ) among HIV-infected adults in Botswana .


We assessed the posttrial durability of this benefit .


A 36-month double-blind placebo controlled trial ( 1:1 randomization ) with recruitment between November 2004 and July 2006 and observation until June 2011 .


One thousand , nine hundred and ninety-five participants were followed in eight public health clinics .


Twenty-four percent had a tuberculin skin test 5mm ( TST-positive ) .


A minimum CD4 lymphocyte count was not required for enrolment .


Antiretroviral therapy ( ART ) was provided in accordance with Botswana guidelines ; 72 % of participants retained by June 2011 had initiated ART .


Multivariable analysis using Cox regression analysis included treatment arm , TST status , ART as a time-dependent variable and CD4 cell count at baseline and updated at 36 months .


In the posttrial period , 2.13 and 2.14 per 100 person-years accumulated , whereas 0.93 and 1.13 % TB incidence rates were observed in the 36IPT and 6IPT arms , respectively ( P = 0.52 ) .


The crude hazard ratio of TB during the trial and posttrial was 0.57 [ 95 % confidence intervals ( CI ) 0.33 , 0.99 ] and 0.82 ( 95 % CI 0.46 , 1.49 ) , and when restricted to TST-positive participants was 0.26 ( 95 % CI 0.08 , 0.80 ) and 0.40 ( 95 % CI 0.15 , 1.08 ) , respectively .


Multivariable analysis showed that ART use was associated with reduced death ( adjusted hazard ratio 0.36 , 95 % CI 0.17-0 .75 ) but not TB ( 0.92 , 95 % CI 0.55-1 .53 ) in the posttrial period .


The benefit of 36IPT for TB prevention declined posttrial in this cohort .


Adjunctive measures are warranted to prevent TB among HIV-infected persons receiving long-term ART in TB-endemic settings .


To evaluate the short-term efficacy and safety of methoxyflurane for the treatment of acute pain in patients presenting to an emergency department ( ED ) with minor trauma .


STOP !


was a randomised , double-blind , multicentre , placebo-controlled study conducted at six sites in the UK .


A total of 300 patients , 90 of whom were adolescent patients ( age 12-17 years ) , were randomised 150:150 to receive either methoxyflurane via a Penthrox inhaler or placebo .


The primary end point of the study was the change in pain intensity as measured using the visual analogue scale ( VAS ) from baseline to 5 , 10 , 15 and 20 min after the start of study drug inhalation .


Patients were supplied with one inhaler containing 3 mL methoxyflurane or 5 mL placebo after enrolment and initial assessments .


Age group ( adolescent/adult ) and baseline VAS score were controlled for in the statistical analyses .


A total of 149 patients received methoxyflurane , and 149 patients received placebo .


Demographic and baseline characteristics were comparable between the groups .


Methoxyflurane reduced pain severity significantly more than placebo ( p < 0.0001 ) at all time points tested , with the greatest estimated treatment effect of -18.5 mm ( adjusted change from baseline ) seen at 15 min after the start of treatment .


Methoxyflurane was well tolerated , with the majority of adverse reactions being mild , transient and in line with anticipated pharmacological action .


The results of this study suggest that methoxyflurane administered via the Penthrox inhaler is an efficacious , safe , and rapidly acting analgesic .


NCT01420159 .


Research has shown that paranoia may directly build on negative ideas about the self .


Feeling inferior can lead to ideas of vulnerability .


The clinical prediction is that decreasing negative self cognitions will reduce paranoia .


Thirty patients with persistent persecutory delusions were randomised to receive brief CBT in addition to standard care or to standard care ( ISRCTN06118265 ) .


The six session intervention was designed to decrease negative , and increase positive , self cognitions .


Assessments at baseline , 8 weeks ( posttreatment ) and 12 weeks were carried out by a rater blind to allocation .


The primary outcomes were posttreatment scores for negative self beliefs and paranoia .


Secondary outcomes were psychological well-being , positive beliefs about the self , persecutory delusions , social comparison , self-esteem , anxiety , and depression .


Trial recruitment and retention were feasible and the intervention highly acceptable to the patients .


All patients provided follow-up data .


Posttreatment there was a small reduction in negative self beliefs ( Cohen 's d = 0.24 ) and a moderate reduction in paranoia ( d = 0.59 ) , but these were not statistically significant .


There were statistically significant improvements in psychological well-being ( d = 1.16 ) , positive beliefs about the self ( d = 1.00 ) , negative social comparison ( d = 0.88 ) , self-esteem ( d = 0.62 ) , and depression ( d = 0.68 ) .


No improvements were maintained .


No adverse events were associated with the intervention .


The intervention produced short-term gains consistent with the prediction that improving cognitions about the self will reduce persecutory delusions .


The improvement in psychological well-being is important in its own right .


We recommend that the different elements of the intervention are tested separately and that the treatment is lengthened .


Tissue oxygenation is a strong predictor of surgical site infection .


Improving tissue oxygenation should thus reduce wound infection risk .


Supplemental inspired oxygen can improve tissue oxygenation , but whether it reduces infection risk remains controversial .


Low-dose dexamethasone is often given to reduce the risk of postoperative nausea and vomiting , but steroid-induced immunosuppression can increase infection risk .


We therefore tested the hypotheses that supplemental perioperative oxygen reduces infection risk and that dexamethasone increases it .


Using a factorial design , patients having colorectal resections expected to last 2 h were randomly assigned to 30 % ( n = 270 ) or 80 % ( n = 285 ) inspired oxygen during and for 1 h after surgery , and to 4 mg intraoperative dexamethasone ( n = 283 ) or placebo ( n = 272 ) .


Physicians blinded to group assignments evaluated wounds postoperatively , using US Centers for Disease Control criteria .


Subject and surgical characteristics were similar among study groups .


Surgical site infection incidence was similar among groups : 30 % oxygen 15.6 % , 80 % oxygen 15.8 % ( P = 1.00 ) ; dexamethasone 15.9 % , placebo 15.4 % , ( P = 0.91 ) .


Supplemental oxygen did not reduce surgical site infection risk .


The preponderance of clinical evidence suggests that administration of 80 % supplemental inspired oxygen does not reduce infection risk .


We did not observe an increased risk of surgical site infection with the use of a single low dose of dexamethasone , indicating that it can be used for nausea and vomiting prophylaxis without promoting wound infections .


ClinicalTrials.gov number : NCT00273377 .


Mental practice using motor imagery of limb movement may facilitate motor recovery in persons who have experienced cerebrovascular accident ( CVA ) .


However , the lack of a feedback mechanism that can monitor the quality of the motor imagery affects patients ' engagement and motivation to participate in the mental practice training program .


This study investigates the effect of novel real-time motor imagery-associated cortical activity feedback on motor imagery-based mental practice training .


Ten healthy volunteers were randomly assigned into intervention and control groups .


Both groups participated in a five-visit motor imagery-based mental practice training program managed over a period of two months .


The intervention group received mental practice training with real-time feedback of movement-associated cortical activity-beta band ( 16-28 Hz ) event-related desynchronization ( ERD ) in electroencephalography ( EEG ) , using a novel custom-made brain-computer interface ( BCI ) system .


The control group received the mental practice training program without EEG cortical feedback .


Motor excitability was assessed by measuring the frequency power magnitude of the EEG rhythmic activity associated with physical execution of wrist extension before and after the motor imagery-based mental practice training .


The EEG frequency power magnitude associated with the physical execution of wrist extension was significantly lower ( i.e. more desynchronized ) after the mental practice training in the intervention group that received real-time cortical feedback ( P < 0.05 ) , whereas no significant difference in EEG frequency power magnitude associated with the physical execution of wrist extension was observed before and after mental practice training in the control group who did not receive feedback .


The mental practice training program with motor imagery-associated cortical feedback facilitated motor excitability during the production of voluntary motor control .


Motor imagery-based mental practice training with movement-associated cortical activity feedback may provide an effective strategy to facilitate motor recovery in brain injury patients , particularly during the early rehabilitation stage when full participation in physical and occupational therapy programs may not be possible due to excessive motor weakness .


To assess whether buccal misoprostol is effective for the treatment of intrauterine fetal death .


This double-blind randomized trial was conducted at five tertiary-level hospitals in the United States and Vietnam .


One hundred fifty-three women with an intrauterine fetal death at 14-28 weeks of pregnancy received either 100 mcg buccal misoprostol or 200 mcg buccal misoprostol every 6 h for a maximum of 8 doses .


The main outcome measure was the fetal-placental delivery rate within 48 hours of prostaglandin commencement without any additional intervention .


Most of the women ( 140/153 ) were recruited at the study site in Vietnam .


Expulsion of both fetus and placenta within 48 hours of prostaglandin commencement without any additional interventions occurred in 61.8 % ( 47/76 ) of women receiving misoprostol 100 mcg and 77.9 % ( 60/77 ) of women receiving misoprostol 200 mcg .


The 200 mcg dose was significantly more effective than the 100 mcg dose at expelling the fetus and placenta within 48 h [ RR 0.68 ( 95 % CI : 0.50-0 .92 ; p = .03 ) ] .


The mean time to expulsion was significantly shorter using the 200 mcg dose ( 18.511.9 h ) than the 100 mcg dose ( 23.912.5 h ) ( p = .02 ) .


Most women in both groups found the procedure satisfactory or very satisfactory ( 100 mcg : 76.7 % ( 56/73 ) ; 200 mcg : 89.5 % ( 68/76 ) [ RR 0.86 ( 95 % CI : 0.74-1 .00 ) ] .


Buccal misoprostol is an effective method for medical induction of labor after intrauterine fetal demise .


A 200 mcg dose is significantly more effective than 100 mcg for evacuating the uterus within 48h .


The treatment is highly acceptable to women .


Administration of 200 mcg buccal misoprostol every six hours is an effective and acceptable method to effect the delivery of a demised fetus at 14-28 weeks that can be feasibly implemented in a wide variety of settings .


Obesity and obstructive sleep apnea tend to coexist and are associated with inflammation , insulin resistance , dyslipidemia , and high blood pressure , but their causal relation to these abnormalities is unclear .


We randomly assigned 181 patients with obesity , moderate-to-severe obstructive sleep apnea , and serum levels of C-reactive protein ( CRP ) greater than 1.0 mg per liter to receive treatment with continuous positive airway pressure ( CPAP ) , a weight-loss intervention , or CPAP plus a weight-loss intervention for 24 weeks .


We assessed the incremental effect of the combined interventions over each one alone on the CRP level ( the primary end point ) , insulin sensitivity , lipid levels , and blood pressure .


Among the 146 participants for whom there were follow-up data , those assigned to weight loss only and those assigned to the combined interventions had reductions in CRP levels , insulin resistance , and serum triglyceride levels .


None of these changes were observed in the group receiving CPAP alone .


Blood pressure was reduced in all three groups .


No significant incremental effect on CRP levels was found for the combined interventions as compared with either weight loss or CPAP alone .


Reductions in insulin resistance and serum triglyceride levels were greater in the combined-intervention group than in the group receiving CPAP only , but there were no significant differences in these values between the combined-intervention group and the weight-loss group .


In per-protocol analyses , which included 90 participants who met prespecified criteria for adherence , the combined interventions resulted in a larger reduction in systolic blood pressure and mean arterial pressure than did either CPAP or weight loss alone .


In adults with obesity and obstructive sleep apnea , CPAP combined with a weight-loss intervention did not reduce CRP levels more than either intervention alone .


In secondary analyses , weight loss provided an incremental reduction in insulin resistance and serum triglyceride levels when combined with CPAP .


In addition , adherence to a regimen of weight loss and CPAP may result in incremental reductions in blood pressure as compared with either intervention alone .


( Funded by the National Heart , Lung , and Blood Institute ; ClinicalTrials.gov number , NCT0371293 . )


Circumcision and lower human papillomavirus ( HPV ) viral loads in men are possibly associated with a reduced risk of HPV transmission to women .


However , the association between male circumcision and HPV viral load remains unclear .


Swab specimens from the glans and shaft of the penis were collected from men enrolled in a circumcision trial in Kisumu , Kenya .


GP5 + / 6 + polymerase chain reaction ( PCR ) was used to identify HPV DNA types .


HPV-16 and HPV-18 loads were measured with a LightCycler real-time PCR and classified as high ( > 250 copies/scrape ) or low ( 250 copies/scrape ) .


A total of 1159 men were randomly assigned to undergo immediate circumcision , and 1140 men were randomly assigned to the control arm ( these individuals were asked to remain uncircumcised until the study ended ) .


The hazard of acquisition of high-viral load infections in the glans was lower in the circumcision arm , compared with the control arm , for HPV-16 ( hazard ratio [ HR ] , 0.32 [ 95 % confidence interval { CI } , .20 -.49 ] ) and HPV-18 ( HR , 0.34 [ 95 % CI , .21 -.54 ] ) .


The 6-month risk of HPV persistence among men with high-viral load infections in the glans at baseline was lower in the circumcision arm , compared with the control arm , for HPV-16 ( risk ratio [ RR ] , 0.36 [ 95 % CI , .18 -.72 ] ) and HPV-18 ( RR 0.34 [ 95 % CI , .13 -.86 ] ) .


Weaker and less precise results were obtained for shaft samples .


Male circumcision could potentially reduce the risk of HPV transmission to women by reducing the hazard of acquisition , and the risk of persistence of high-HPV viral load infections in the glans in men .


Previous cell-based and animal studies showed mixed tocotrienols are neuroprotective , but the effect is yet to be proven in humans .


Thus , the present study aimed to evaluate the protective activity of mixed tocotrienols in humans with white matter lesions ( WMLs ) .


WMLs are regarded as manifestations of cerebral small vessel disease , reflecting varying degrees of neurodegeneration and tissue damage with potential as a surrogate end point in clinical trials .


A total of 121 volunteers aged 35 years with cardiovascular risk factors and MRI-confirmed WMLs were randomized to receive 200 mg mixed tocotrienols or placebo twice a day for 2 years .


The WML volumes were measured from MRI images taken at baseline , 1 year , and 2 years using a validated software and were compared .


Fasting blood samples were collected for full blood chemistry investigation .


According to per-protocol ( 88 volunteers ) and intention-to-treat ( 121 volunteers ) analyses , the mean WML volume of the placebo group increased after 2 years , whereas that of the tocotrienol-supplemented group remained essentially unchanged .


The mean WML volume change between the 2 groups was not significantly different ( P = 0.150 ) at the end of 1 year but was significant at the end of 2 years for both per-protocol and intention-to-treat analyses ( P = 0.019 and P = 0.018 ) .


No significant difference was observed in the blood chemistry parameters between the 2 groups .


Mixed tocotrienols were found to attenuate the progression of WMLs .


http://www.clinicaltrials.gov .


Unique identifier : NCT00753532 .


Fimasartan is a novel angiotensin II receptor blocker .


Fimasartan is mainly eliminated via biliary excretion , and its urinary elimination is less than 3 % .


Based on guidance from the United States Food and Drug Administration , a reduced pharmacokinetic ( PK ) study was conducted to evaluate the effect of renal function on the PK of fimasartan in patients with renal impairment and healthy volunteers .


A single centre , single-dose , open-label , healthy volunteer controlled trial was conducted in patients with renal impairment ( RI ) ( estimated glomerular filtration rate lower than 30 mL/min/1 .73 m ( 2 ) ) and age - , weight - and sex-matched healthy volunteers ( estimated glomerular filtration rate higher than 90 mL/min/1 .73 m ( 2 ) ) .


All participants received a single oral dose of fimasartan 120 mg , after which serial blood sampling for PK evaluation was conducted .


Noncompartmental PK analysis of fimasartan was performed .


A mixed-effects model approach was used to identify significant covariates and PK parameters .


Sixteen subjects were enrolled ( 8 healthy volunteers and 8 RI patients ) .


The maximum plasma concentrations and areas under the plasma concentration curves of the RI patients were higher than those of the healthy volunteers , with geometric mean ratios of 1.87 and 1.73 , respectively .


The relative bioavailability of fimasartan from the population PK analysis was 77 % higher in the RI patients than in the healthy volunteers .


The increased drug exposure of fimasartan in RI patients was explained by the increased relative bioavailability .


This result can be explained from our knowledge concerning alterations in PK related to renal function .


Milk may stimulate growth acting via insulin-like growth factor-I ( IGF-I ) secretion but the effect in adolescents is less examined .


This study investigates the effect of milk proteins on linear growth , IGF-I , IGF binding protein-3 ( IGFBP-3 ) and IGF-I/IGFBP -3 ratio in overweight adolescents .


The trial included 193 overweight adolescents aged 12-15 years .


They were randomized to drink 1L/day of : skimmed milk , whey , casein or water for 12 weeks ; all milk-based drinks contained 35 g protein/L .


A subgroup of 32 adolescents was examined 12 weeks before they were randomized into the groups and started the intervention ( pre-test control group ) .


Examinations included anthropometry , diet registration and blood samples which were analyzed for IGF-I and IGFBP-3 by chemiluminescence methods .


The effects of milk-based drinks on linear growth , IGF-I , IGFBP-3 and IGF-I availability , calculated as the IGF-I/IGFBP -3 ratio , were compared with baseline , the pre-test control group and water .


IGF-I increased with skimmed milk ( P = 0.015 ) and tended to increase with casein ( P = 0.075 ) compared to the pre-test control group .


IGFBP-3 but not IGF-I increased with skimmed milk ( P = 0.006 ) and casein ( P = 0.001 ) compared to water .


There was no difference in height or height Z-score for any of the milk-based test drink groups compared to water or compared to the pre-test control group .


However , height Z-score decreased within the whey group .


Skimmed milk and casein may have a stimulating effect on the IGF-I system whereas there was no positive effect on height in overweight adolescents during this 12 week intervention .


Mutations in lipoprotein-associated phospholipase A2 ( Lp-PLA2 ) are related to atherosclerosis .


However , the molecular effects of Lp-PLA2 on atherosclerosis have not been fully investigated .


Therefore , this study attempted to elucidate this issue .


Monocytes were isolated from randomly selected healthy male volunteers according to each Lp-PLA2 genotype ( wild-type Lp-PLA2 [ Lp-PLA2 ( V/V ) ] , the heterozygous V279F mutation [ LpPLA2 ( V/F ) ] and the homozygous V279F mutation [ Lp-PLA2 ( F/F ) ] ) and differentiated into macrophages .


The level of apoptosis in the macrophages following incubation without serum was measured using the annexin V/propidium iodide double staining method , and the underlying mechanisms were further examined using a culture cell line .


The average plasma Lp-PLA2 concentration [ Lp-PLA2 ( V/V ) : 129.4 ng/mL , Lp-PLA2 ( V/F ) : 70.7 ng/mL , Lp-PLA2 ( F/F ) : 0.4 ng/mL ] and activity [ Lp-PLA2 ( V/V ) : 164.3 nmol/min/mL , LpPLA2 ( V/F ) : 100.9 nmol/min/mL , Lp-PLA2 ( F/F ) : 11.6 nmol/min/mL ] were significantly different between each genotype , although the basic clinical characteristics were similar .


The percentage of apoptotic cells was significantly higher among the Lp-PLA2 ( F/F ) macrophages compared with that observed in the Lp-PLA2 ( V/V ) macrophages .


This induction of apoptosis was independent of the actions of acetylated low-density lipoproteins .


In addition , the transfection of the expression plasmid of V279F mutant Lp-PLA2 into Cos-7 cells or monocyte/macrophage-like U937 cells promoted apoptosis .


The knockdown of Lp-PLA2 also increased the number of apoptotic cells .


Among the cells expressing mutant Lp-PLA2 , the caspase-7 activity was increased , while the activated Akt level was decreased .


The V279F mutation of Lp-PLA2 positively regulates the induction of apoptosis in macrophages and Cos-7 cells .


An increase in the caspase-7 activity and a reduction in the activated Akt level are likely to be involved in this phenomenon .


Female libido is multifactorial and complex .


Declining estrogen levels in postmenopausal women affects vaginal function .


The aim of this study was to evaluate female sexual function after using topical estrogen , testosterone , or polyacrylic acid as vaginal lubricants with K-Y jelly as a placebo lubricant .


This was a randomized controlled clinical trial on 80 postmenopausal women between 40 and 70 years of age with follow-up at the Menopause Clinic of the CAISM Unicamp .


The women were randomized to treatment with topical vaginal estrogen , testosterone , polyacrylic acid , or oil lubricant alone , three times a week for a period of 12 weeks from November 2011 to January 2013 .


We used the Female Sexual Function Index ( FSFI ) to assess changes in sexual response at baseline , and after 6 and 12 weeks .


After 12 weeks of treatment , polyacrylic acid and topical testosterone produced improvements in the FSFI domains of sexual desire , lubrication , satisfaction , reduced pain during intercourse , and total score compared with lubricant alone .


Treatment with topical estrogen in comparison with lubricant alone showed an improvement in the FSFI field of desire .


The intragroup analysis over the time of the treatment showed improvements in the fields of desire , lubrication , and reduced pain for polyacrylic acid , testosterone , and estrogen .


Furthermore , women who used testosterone showed improvements over time in the fields of arousal , orgasm , and satisfaction .


Treatment of postmenopausal women with symptoms of vaginal atrophy with polyacrylic acid , testosterone , and estrogen for 12 weeks produced improvements in self-reported female sexual function when compared with a placebo lubricant .


The rate of falls in community dwelling older people with cognitive impairment ( CI ) is twice that of a cognitively intact population , with almost two thirds of people with CI falling annually .


Studies indicate that exercise involving balance and/or a home hazard reduction program are effective in preventing falls in cognitively intact older people .


However the potential benefit of these interventions in reducing falls in people with CI has not been established.This randomised controlled trial will determine whether a tailored exercise and home hazard reduction program can reduce the rate of falls in community dwelling older people with CI .


We will determine whether the intervention has beneficial effects on a range of physical and psychological outcome measures as well as quality of life of participants and their carers .


A health economic analysis examining the cost and potential benefits of the program will also be undertaken .


Three hundred and sixty people aged 65years or older living in the community with CI will be recruited to participate in the trial .


Each will have an identifiable carer with a minimum of 3.5 hours of face to face contact each week.Participants will undergo an assessment at baseline with retests at 6 and 12months .


Participants allocated to the intervention group will participate in an exercise and home hazard reduction program tailored to their cognitive and physical abilities.The primary outcome measure will be the rate of falls which will be measured using monthly falls calendars .


Secondary outcome measures will include the risk of falling , quality of life , measures of physical and cognitive function , fear of falling and planned and unplanned use of health services .


Carers will be followed up to determine carer burden , coping strategies and quality of life .


The study will determine the impact of this tailored intervention in reducing the rate of falls in community dwelling older people with CI as well as the cost-effectiveness and adherence to the program .


The results will have direct implications for the design and implementation of interventions for this high-risk group of older people .


The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry - ACTRN12614000603617 .


The aim of the article is to determine whether maternal body mass index ( BMI ) influences the beneficial effects of diabetes treatment in women with gestational diabetes mellitus ( GDM ) .


Secondary analysis of a multicenter randomized treatment trial of women with GDM .


Outcomes of interest were elevated umbilical cord c-peptide levels ( > 90th percentile 1.77 ng/mL ) , large for gestational age ( LGA ) birth weight ( > 90th percentile ) , and neonatal fat mass ( g ) .


Women were grouped into five BMI categories adapted from the World Health Organization International Classification of normal , overweight , and obese adults .


Outcomes were analyzed according to treatment group assignment .


A total of 958 women were enrolled ( 485 treated and 473 controls ) .


Maternal BMI at enrollment was not related to umbilical cord c-peptide levels .


However , treatment of women in the overweight , Class I , and Class II obese categories was associated with a reduction in both LGA birth weight and neonatal fat mass .


Neither measure of excess fetal growth was reduced with treatment in normal weight ( BMI < 25 kg/m ( 2 ) ) or Class III ( BMI40 kg/m ( 2 ) ) obese women .


There was a beneficial effect of treatment on fetal growth in women with mild GDM who were overweight or Class I and Class II obese .


These effects were not apparent for normal weight and very obese women .


Low levels of adiponectin and T in men have been shown to predict development of the metabolic syndrome , but the effects of T on glucose metabolism are incompletely understood and may be influenced either directly or indirectly through changes in body composition or in levels of adiponectin .


The aim of the study was to test whether T exerts its effects on glucose metabolism directly or indirectly .


In a randomized , double-blind , placebo-controlled , crossover study , 12 healthy young males were studied on four separate occasions .


They received GnRH agonist treatment 1 month before 3 of 4 trial days to induce castrate levels of T. On trial days , T gel containing either high or low physiological T dose or placebo was applied to the body .


On a fourth trial day , participants constituted their own eugonadal controls .


Each study comprised a 5-hour basal period and a 3-hour hyperinsulinemic euglycemic clamp .


We measured the effect of acute T on peripheral glucose disposal , total adiponectin and subforms , and other indices of glucose metabolism .


Short-term hypogonadism was associated with increased high molecular weight adiponectin levels ( P < .03 ) and increased oxidative glucose disposal ( P = .03 ) but not total glucose disposal ( P = .07 ) .


Acute T treatment was an independent suppressor of high molecular weight adiponectin levels ( P = .04 ) but did not affect total glucose disposal ( P = .17 ) .


These data show that T can act through putative fast nongenomic pathways to affect adiponectin levels in humans .


The early hypogonadal state is characterized by a marked shift in fuel oxidation from lipids toward glucose , which may rely partly on buffering capabilities of adiponectin .


The effectiveness of axillary brachial plexus block ( ABPB ) performed using peripheral nerve stimulation ( PNS ) alone was compared with PNS preceded by nerve localization using a pen device , enabling nerve mapping without puncturing the skin .


Patients undergoing unilateral hand or forearm surgery suitable for ABPB were randomly assigned to receive either PNS alone ( pen - group ) or PNS preceded by nerve localization using a pen device ( pen + group ) .


Parameters related to the block procedure and patient comfort were assessed .


Thirty patients were included in each group .


The block performance time was longer in the pen + group than the pen - group despite a reduced number of needle insertions .


The complete block rate was higher and intraoperative analgesic usage lower in the pen + group compared with the pen - group .


Patient satisfaction and complication rates were similar in the two groups .


The pen device seems to be a helpful addition to PNS for ABPB , with improved results in terms of block success and patient comfort , but further studies are needed to confirm these findings .


The purpose of this study was to investigate the effectiveness of a 10 percent casein phosphopeptide-amorphous calcium phosphate ( CPP-ACP ) cream to reduce mutans streptococci ( MS ) colonization and prevent early childhood caries .


The cohort was randomized at mean age of 11 days old to receive once-daily CPP-ACP cream ( n = 102 ) or no product ( comparison group ; n = 89 ) from the time of first tooth eruption .


All mothers were contacted by telephone at six , 12 , and 18 months and advised to brush their children 's teeth twice daily with low-dose fluoride toothpaste .


At 24 months , all children were examined at a community clinic .


At 24 months old , one out of 65 ( 2 percent ) children in the CPP-ACP group had caries vs. four out of 58 ( seven percent ) in the comparison group ( difference not statistically significant ) .


There were fewer MS-positive children in the CPP-ACP group ( 26 percent ) vs. the comparison group ( 47 percent ; P = .02 ) .


A dose-response effect of CPP-ACP usage on MS was observed , where MS was present in eight percent of regular CPP-ACP users , 28 percent of irregular users , and 47 percent of non-users ( P < .02 ) .


CPP-ACP reduced the percentages of mutans streptococci-positive 24-month-old children , although it did not reduce caries prevalence .


To test the cost-effectiveness of a home-based depression program : Beat the Blues ( BTB ) .


A cost-effectiveness analysis as part of a previously reported randomized controlled trial that compared BTB with a wait-list control group .


Community .


English-speaking , cognitively intact ( Mini-Mental State Examination score 24 ) , African Americans aged 55 and older with depressive symptoms ( Patient Health Questionnaire score 5 ) ( N = 129 ) .


Participants randomly assigned to BTB received up to 10 home visits over 4 months from licensed social workers who provided care management , referral and linkage , stress reduction , depression education , and behavioral activation to help participants achieve self-identified goals .


Incremental cost-effectiveness ratios ( ICERs ) of BTB versus wait-list controls during the 4-month study period .


The primary ICER was defined as cost per quality-adjusted life year ( QALY ) using the Euro Quality of Life 5D ( EQ-5D ) and secondarily using the Health Utilities Index-3 ( HUI-3 ) .


Additional ICERs were calculated using clinical measures ( cost per depression improvement , cost per depression remission ) .


Costs included BTB intervention , depression-related healthcare visits and medications , caregiver time , and social services .


BTB cost per participant per month was $ 146 .


Base case ICERs were $ 64,896 per QALY ( EQ-5D ) and $ 36,875 per QALY ( HUI-3 ) .


Incremental cost was $ 2,906 per depression improvement and $ 3,507 per remission .


Univariate and probabilistic sensitivity analyses yielded a cost/QALY range of $ 20,500 to $ 76,500 .


Based on the range of cost-effectiveness values resulting from this study , BTB is a cost-effective treatment for managing depressive symptoms in older African Americans that compares favorably with the cost-effectiveness of previously tested approaches .


Most patients relapse to opioids within one month of opioid agonist detoxification , making the antecedents and parallel processes of first use critical for investigation .


Craving and withdrawal are often studied in relationship to opioid outcomes , and a novel analytic strategy applied to these two phenomena may indicate targeted intervention strategies .


Specifically , this secondary data analysis of the Prescription Opioid Addiction Treatment Study used a discrete-time mixture analysis with time-to-first opioid use ( survival ) simultaneously predicted by craving and withdrawal growth trajectories .


This analysis characterized heterogeneity among prescription opioid-dependent individuals ( N = 653 ) into latent classes ( i.e. , latent class analysis [ LCA ] ) during and after buprenorphine/naloxone stabilization and taper .


A 4-latent class solution was selected for overall model fit and clinical parsimony .


In order of shortest to longest time-to-first use , the 4 classes were characterized as 1 ) high craving and withdrawal , 2 ) intermediate craving and withdrawal , 3 ) high initial craving with low craving and withdrawal trajectories and 4 ) a low initial craving with low craving and withdrawal trajectories .


Odds ratio calculations showed statistically significant differences in time-to-first use across classes .


Generally , participants with lower baseline levels and greater decreases in craving and withdrawal during stabilization combined with slower craving and withdrawal rebound during buprenorphine taper remained opioid-free longer .


This exploratory work expanded on the importance of monitoring craving and withdrawal during buprenorphine induction , stabilization , and taper .


Future research may allow individually tailored and timely interventions to be developed to extend time-to-first opioid use .


Acne keloidalis nuchae ( AKN ) is a chronic scarring folliculitis with fibrotic papules on the occipital scalp .


Its treatment is limited and unsatisfactory .


To determine whether targeted ultraviolet B ( tUVB ) phototherapy will ( i ) improve the clinical appearance of AKN and ( ii ) induce extracellular matrix remodelling in affected lesions .


Eleven patients with AKN were enrolled in a prospective , randomized , split-scalp comparison study .


One randomly selected side of the scalp was treated with tUVB up to three times weekly for 8weeks .


After week 8 , both sides were treated for eight additional weeks .


Assessment included lesion counts in two 33-cm regions of interest ( ROIs ) , one on each side of the scalp ( ROI-1 : tUVB weeks 0-16 , ROI-2 : tUVB weeks 9-16 ) , patient self-assessment and analysis of MMP1 , MMP9 , TGFB1 and COL1A1 mRNA expression by quantitative reverse-transcription polymerase chain reaction .


Before treatment , the mean lesion count was similar between tUVB-treated and untreated sides ( 148 vs. 150 ) .


After 8weeks of tUVB , the mean lesion count decreased significantly to 9412 ( P = 003 ) , with no change on the untreated side .


With continued treatment , the mean lesion count in ROI-1 decreased further to 715 ( P = 004 ) after 16weeks of tUVB .


tUVB significantly improved the clinical appearance of AKN , led to patient satisfaction and was well tolerated .


Carpal tunnel syndrome ( CTS ) is a common condition ( prevalence of 4 % ) where the median nerve is compressed within the carpal tunnel resulting in numbness , tingling , and pain in the hand .


Current non-surgical treatment options ( oral medication , corticosteroid injections , splinting , exercise , and mobilization ) show limited effects , especially in the long-term .


Carpal tunnel release ( CTR ) surgery is effective in 70 to 75 % of patients , but is relatively invasive and can be accompanied by complications .


In an observational study , mechanical traction proved to be effective in up to 70 % of patients directly after treatment and in 60 % after two years follow-up .


This randomized controlled trial ( RCT ) will examine the effectiveness of mechanical traction compared to care as usual in CTS .


Patients diagnosed with CTS will be recruited from an outpatient neurology clinic and randomly assigned to the intervention group ( mechanical traction ) or the control group ( care as usual ) .


Participants in the intervention group will receive 12 treatments with mechanical traction during six consecutive weeks .


Primary outcome is symptom severity and functional status , which are measured with the Boston Carpel Tunnel Questionnaire ( BCTQ ) .


Secondary outcomes are quality of life ( WHOQOL-BREF ) , health related resource utilization , and absenteeism from work .


Outcomes will be assessed at baseline , and at 3 , 6 , and 12months after inclusion .


Linear mixed effect models will be used to determine the change from baseline at 12months on the BCTQ , WHOQOL-BREF , absenteeism from work and health related resource utilization .


The baseline measurement , change from baseline at three and six months , as well as duration of symptoms until inclusion , age , gender , and co-morbidity will be included as covariates The Pearson 's correlation coefficient will be generated to assess the correlation between depression and anxiety and treatment outcome .


Since current non-surgical treatment options are not effective long-term and CTR is relatively invasive , there is a need for an effective and non-invasive treatment option .


Mechanical traction is a safe treatment option that may provide a good alternative for the usual care .


Considering the prevalence of CTS , the study is of great clinical value to a large patient population .


Clinical Trials NL44692 .008.13 ( registered on 19 September 2013 ) .


Effective prophylactic therapies have not been established for hepatocellular carcinoma recurrence .


Peretinoin represents one novel option for patients with hepatitis C virus-related hepatocellular carcinoma ( HCV-HCC ) , and it was tested in a multicenter , randomized , double-blind , placebo-controlled study .


Patients with curative therapy were assigned to one of the following regimens : peretinoin 600 , 300 mg/day , or placebo for up to 96 weeks .


The primary outcome was recurrence-free survival ( RFS ) .


Of the 401 patients initially enrolled , 377 patients were analyzed for efficacy .


The RFS rates in the 600-mg group , the 300-mg group , and the placebo group were 71.9 , 63.6 , and 66.0 % at 1 year , and 43.7 , 24.9 , and 29.3 % at 3 years , respectively .


The primary comparison of peretinoin ( 300 and 600-mg ) with placebo was not significant ( P = 0.434 ) .


The dose-response relationship based on the hypothesis that `` efficacy begins to increase at 600 mg/day '' was significant ( P = 0.023 , multiplicity-adjusted P = 0.048 ) .


The hazard ratios for RFS in the 600-mg group vs. the placebo group were 0.73 [ 95 % confidence interval ( CI ) 0.51-1 .03 ] for the entire study period and 0.27 ( 95 % CI 0.07-0 .96 ) after 2 years of the randomization .


Common adverse events included ascites , increased blood pressure , headache , presence of urine albumin , and increased transaminases .


Although the superiority of peretinoin to placebo could not be validated , 600 mg/day was shown to be the optimal dose , and treatment may possibly reduce the recurrence of HCV-HCC , particularly after 2 years .


The efficacy and safety of peretinoin 600 mg/day should continue to be evaluated in further studies .


Postoperative delirium is one of the most common complications of major surgery , affecting 10-70 % of surgical patients 60 years and older .


Delirium is an acute change in cognition that manifests as poor attention and illogical thinking and is associated with longer intensive care unit ( ICU ) and hospital stay , long-lasting cognitive deterioration and increased mortality .


Ketamine has been used as an anaesthetic drug for over 50 years and has an established safety record .


Recent research suggests that , in addition to preventing acute postoperative pain , a subanaesthetic dose of intraoperative ketamine could decrease the incidence of postoperative delirium as well as other neurological and psychiatric outcomes .


However , these proposed benefits of ketamine have not been tested in a large clinical trial .


The Prevention of Delirium and Complications Associated with Surgical Treatments ( PODCAST ) study is an international , multicentre , randomised controlled trial .


600 cardiac and major non-cardiac surgery patients will be randomised to receive ketamine ( 0.5 or 1 mg/kg ) or placebo following anaesthetic induction and prior to surgical incision .


For the primary outcome , blinded observers will assess delirium on the day of surgery ( postoperative day 0 ) and twice daily from postoperative days 1-3 using the Confusion Assessment Method or the Confusion Assessment Method for the ICU .


For the secondary outcomes , blinded observers will estimate pain using the Behavioral Pain Scale or the Behavioral Pain Scale for Non-Intubated Patients and patient self-report .


The PODCAST trial has been approved by the ethics boards of five participating institutions ; approval is ongoing at other sites .


Recruitment began in February 2014 and will continue until the end of 2016 .


Dissemination plans include presentations at scientific conferences , scientific publications , stakeholder engagement and popular media .


The study is registered at clinicaltrials.gov , NCT01690988 ( last updated March 2014 ) .


The PODCAST trial is being conducted under the auspices of the Neurological Outcomes Network for Surgery ( NEURONS ) .


NCT01690988 ( last updated December 2013 ) .


Malnutrition is common in patients with advanced epithelial ovarian cancer ( EOC ) , and is associated with impaired quality of life ( QoL ) , longer hospital stay and higher risk of treatment-related adverse events .


This phase III multi-centre randomised clinical trial tested early enteral feeding versus standard care on postoperative QoL .


From 2009 to 2013 , 109 patients requiring surgery for suspected advanced EOC , moderately to severely malnourished were enrolled at five sites across Queensland and randomised to intervention ( n = 53 ) or control ( n = 56 ) groups .


Intervention involved intraoperative nasojejunal tube placement and enteral feeding until adequate oral intake could be maintained .


Despite being randomised to intervention , 20 patients did not receive feeds ( 13 did not receive the feeding tube ; 7 had it removed early ) .


Control involved postoperative diet as tolerated .


QoL was measured at baseline , 6weeks postoperatively and 30days after the third cycle of chemotherapy .


The primary outcome measure was the difference in QoL between the intervention and the control group .


Secondary endpoints included treatment-related adverse event occurrence , length of stay , postoperative services use , and nutritional status .


Baseline characteristics were comparable between treatment groups .


No significant difference in QoL was found between the groups at any time point .


There was a trend towards better nutritional status in patients who received the intervention but the differences did not reach statistical significance except for the intention-to-treat analysis at 7days postoperatively ( 11.8 intervention vs. 13.8 control , p 0.04 ) .


Early enteral feeding did not significantly improve patients ' QoL compared to standard of care but may improve nutritional status .


As healthcare services become progressively more stretched , there is increasing discussion of ways in which technological adjuncts may be used to deliver more cost-efficient services .


Before widespread implementation , however , the use of these adjuncts requires proper scrutiny of their effects on psychological practice .


This research examined the effectiveness of SMS reminders on client appointment attendance and dropout in a psychological treatment setting .


It was predicted that the reminders would result in increased initial appointment attendance , increased total appointment attendance , and decreased client dropout .


A randomized controlled trial investigated the impact of SMS appointment reminders ( two levels : present or absent ) on client attendance ( three levels : attended , rescheduled , or did not attend ) and dropout ( two levels : completed treatment or terminate early ) .


Participants ( N = 140 ) at an outpatient psychology clinic were randomly allocated to either receive an SMS appointment reminder one day before their scheduled appointment , or to receive no reminder .


No significant differences were found between the SMS and no SMS conditions in relation to appointment attendance .


There were more client dropouts in the SMS compared to the no SMS condition .


The SMS appointment reminders were not effective at increasing appointment attendance .


The current research suggests that there is more to client non-attendance in psychological settings than the simple forgetting of appointments .


Technological adjuncts may be useful in increasing the cost-efficiency of current services ; however , this research highlights the importance of understanding the effects of technology before widespread implementation .


In this study , our objective was to determine whether a perioperative hemodynamic protocol based on noninvasive cardiac output monitoring decreases the incidence of postoperative complications and hospital length of stay in major abdominal surgery patients requiring intensive care unit admission .


Secondary objectives were the time to peristalsis recovery and the incidence of wound infection , anastomotic leaks , and mortality .


A randomized clinical trial was conducted in 6 tertiary hospitals .


One hundred forty-two adult patients scheduled for open colorectal surgery , gastrectomy , or small bowel resection were enrolled .


A hemodynamic protocol including fluid administration and vasoactive drugs based on arterial blood pressure , cardiac index , and stroke volume response was compared with standard practice .


Patients were followed until hospital discharge ( determined by a surgeon blinded to the study ) or death .


In contrast to previous studies , we designed a pragmatic trial ( as opposed to explanatory trials ) to mimic real practice and obtain maximal external validity for the study .


Fluid administration was similar except for the number of colloid boluses ( 2.4 1.8 [ treated ] vs 1.3 1.4 [ control ] ; P < 0.001 ) and packed red blood cell units ( 0.6 1.3 [ treated ] vs 0.2 0.6 [ control ] ; P = 0.019 ) .


Dobutamine was used in 25 % ( intraoperatively ) and 19.4 % ( postoperatively ) of the treated patients versus 1.4 % and 0 % in the control group ( P < 0.001 ) .


We have observed a reduction in reoperations in the treated group ( 5.6 % vs 15.7 % ; P = 0.049 ) .


However , no significant differences were observed in overall complications ( 40 % vs 41 % ; relative risk 0.99 [ 0.67-1 .44 ] ; P = 0.397 ) , length of stay ( 11.5 [ 8-15 ] vs 10.5 [ 8-16 ] ; P = 0.874 ) , time to first flatus ( 62 hours [ 40-76 ] vs 72 hours [ 48-96 ] ; P = 0.180 ) , wound infection ( 7 vs 14 ; P = 0.085 ) , anastomotic leaks ( 2 vs 5 ; P = 0.23 ) , or mortality ( 4.2 % vs 5.7 % ; P = 0.67 ) .


The results of our pragmatic study indicate that a perioperative hemodynamic protocol guided by a noninvasive cardiac output monitor was not associated with a decrease in the incidence of overall complications or length of stay in major abdominal surgery .


The quality of cardiopulmonary resuscitation ( CPR ) affects hemodynamics , survival , and neurological outcomes following pediatric cardiopulmonary arrest ( CPA ) .


Most health care professionals fail to perform CPR within established American Heart Association guidelines .


To determine whether `` just-in-time '' ( JIT ) CPR training with visual feedback ( VisF ) before CPA or real-time VisF during CPA improves the quality of chest compressions ( CCs ) during simulated CPA .


Prospective , randomized , 22 factorial-design trial with explicit methods ( July 1 , 2012 , to April 15 , 2014 ) at 10 International Network for Simulation-Based Pediatric Innovation , Research , & Education ( INSPIRE ) institutions running a standardized simulated CPA scenario , including 324 CPR-certified health care professionals assigned to 3-person resuscitation teams ( 108 teams ) .


Each team was randomized to 1 of 4 permutations , including JIT training vs no JIT training before CPA and real-time VisF vs no real-time VisF during simulated CPA .


The proportion of CCs with depth exceeding 50 mm , the proportion of CPR time with a CC rate of 100 to 120 per minute , and CC fraction ( percentage CPR time ) during simulated CPA .


The quality of CPR was poor in the control group , with 12.7 % ( 95 % CI , 5.2 % -20.1 % ) mean depth compliance and 27.1 % ( 95 % CI , 14.2 % -40.1 % ) mean rate compliance .


JIT training compared with no JIT training improved depth compliance by 19.9 % ( 95 % CI , 11.1 % -28.7 % ; P < .001 ) and rate compliance by 12.0 % ( 95 % CI , 0.8 % -23.2 % ; P = .037 ) .


Visual feedback compared with no VisF improved depth compliance by 15.4 % ( 95 % CI , 6.6 % -24.2 % ; P = .001 ) and rate compliance by 40.1 % ( 95 % CI , 28.8 % -51.3 % ; P < .001 ) .


Neither intervention had a statistically significant effect on CC fraction , which was excellent ( > 89.0 % ) in all groups .


Combining both interventions showed the highest compliance with American Heart Association guidelines but was not significantly better than either intervention in isolation .


The quality of CPR provided by health care professionals is poor .


Using novel and practical technology , JIT training before CPA or real-time VisF during CPA , alone or in combination , improves compliance with American Heart Association guidelines for CPR that are associated with better outcomes .


clinicaltrials.gov Identifier : NCT02075450 .


Multiple sclerosis ( MS ) is an immune-mediated neurodegenerative disease of central nervous system and recent studies show that inflammatory processes are highly associated with neurodegeneration in the brain .


The purpose of this study was to investigate the effect of coenzyme Q10 supplementation on inflammatory and anti-inflammatory markers in patients with MS.


This randomized , double-blind , placebo-controlled clinical study was performed among 48 patients with relapsing-remitting MS. Subjects were randomly assigned to a placebo group ( n = 24 ) or coenzyme Q10 ( CoQ10 ) - supplemented group ( 500 mg/day , n = 24 ) .


The intervention was administered for 12 weeks .


Peripheral blood samples were collected at baseline and after 12-week intervention , to measure inflammatory ( tumor necrosis factor - ( TNF - ) , interleukin ( IL ) -6 , and matrix metalloproteinase ( MMP ) -9 ) and anti-inflammatory ( IL-4 and TGF - ) markers .


Forty-five patients completed the study .


After 12 weeks of intervention , the TNF - levels ( P = 0.003 ) decreased significantly in the CoQ10 group .


Subjects in the CoQ10 group had significantly lower IL-6 levels ( P = 0.037 ) , compared to the placebo group .


CoQ10 supplementation also resulted in decreased serum levels of MMP-9 as compared to the placebo group ( P = 0.011 ) .


However , CoQ10 supplementation did not alter the IL-4 and TGF - levels ( P = 0.16 and P = 0.81 , respectively ) .


CoQ10 supplementation at a dosage of 500 mg appears to decrease the inflammatory markers ( TNF - , IL-6 , and MMP-9 ) in patients with MS.


The objective of the study was to assess the effect of T treatment on constitutional and sexual symptoms in men with type 2 diabetes ( T2D ) .


This was a randomized double-blind , parallel , placebo-controlled trial .


The study was conducted at a tertiary referral center .


Men aged 35-70 years with T2D , a hemoglobin A1c less than 8.5 % , and a total T level less than 12.0 nmol/L ( 346 ng/dL ) with mild to moderate aging male symptoms and erectile dysfunction .


Eighty-eight participants were randomly assigned to 40 weeks of im T undecanoate ( n = 45 ) or matching placebo ( n = 43 ) .


Constitutional symptoms using the aging male symptoms ( AMS ) score , sexual desire ( question 17 AMS score ) , and erectile function ( International Index of Erectile Function-5 ) .


T treatment did not substantially improve aging male symptoms [ mean adjusted difference ( MAD ) in change over 40 weeks across the T and placebo groups in AMS total score , -0.9 ( 95 % confidence interval [ CI ] -4.1 , 2.2 ) , P = .67 ] or sexual desire [ MAD in question 17 AMS , -0.3 ( 95 % CI -0.8 , 0.2 ) , P = .17 ] .


Although compared with placebo , erectile function in men assigned to T was reduced [ MAD in International Index of Erectile Function abridged version 5 , -2.0 ( 95 % CI -3.4 , -0.6 ) , P < .02 ] , there was no significant difference between baseline and 40-week International Index of Erectile Function abridged version 5 scores if both groups were analyzed separately .


At baseline , symptoms were worse in men with depression and microvascular complications but did not correlate with T levels .


In this trial , T treatment did not substantially improve constitutional or sexual symptoms in obese , aging men with T2D with mild to moderate symptoms and modest reduction in T levels typical for the vast majority of such men .


According to the findings of some studies , instability due to inertia during changes in speed may negatively impact the quality of chest compressions performed during cardiopulmonary resuscitation ( CPR ) in a moving environment .


This study thus aimed to introduce a simple device that maintains the balance of a person performing CPR in a moving environment , such as an ambulance .


We also sought to evaluate the effectiveness of this device in the improvement of the quality of chest compressions .


The experiment comprised a total of 40 simulated cardiopulmonary arrest scenes ( 20 in the experimental group and 20 in the control ) , in which CPR was conducted by eight paramedics .


Each simulation involved two paramedics randomly selected from the eight .


The ambulance took the same route from the simulated site to the hospital , and continuous CPR was performed on a manikin in the ambulance with or without the aid of our proposed novel device .


The average number of chest compressions per simulation in the experimental and control groups was 1330.75 and 1266.60 , respectively ( p = 0.095 ) .


The percentage of chest compressions with adequate depth achieved in the experimental and control groups was 72 % 4 % and 50 % 3 % , respectively ( p < 0.0001 ) .


By maintaining the balance of the CPR performer , our proposed novel device can offset the negative impact that instability ( due to a moving environment ) has on chest compressions .


The device may also lead to an increase in the percentage of chest compressions that achieve adequate depth .


This pilot study examined , whether long-term exposure of psychiatric patients to music that was individually adapted to brain rhythm disorders associated with psychoticism could act to ameliorate psychiatric symptoms .


A total of 50 patients with various psychiatric diagnoses were randomised in a 1:1 ratio to listen to CDs containing either music adapted to brain rhythm anomalies associated with psychoticism - measured via a specific spectral analysis - or standard classical music .


Participants were instructed to listen to the CDs over the next 18 months .


Psychiatric symptoms in both groups were assessed at baseline and at 4 , 8 and 18 months , using the Brief Symptom Inventory ( BSI ) .


At 18 months , patients in the experimental group showed significantly decreased BSI scores compared to control patients .


Intriguingly , this effect was not only seen for symptoms of psychoticism and paranoia but also for anxiety , phobic anxiety and somatisation .


Exposure to the adapted music was effective in ameliorating psychotic , anxiety and phobic anxiety symptoms .


Based on the theories of neuroplasticity and brain rhythms , it can be hypothesised that this intervention may be enhancing brain-rhythm synchronisation and plasticity in prefrontal-hippocampal circuits that are implicated in both psychosis/paranoia and anxiety/phobic anxiety .


High US sodium intake and national reduction efforts necessitate developing a feasible and valid monitoring method across the distribution of low-to-high sodium intake .


We examined a statistical approach using timed urine voids to estimate the population distribution of usual 24-h sodium excretion .


A sample of 407 adults , aged 18-39 y ( 54 % female , 48 % black ) , collected each void in a separate container for 24 h ; 133 repeated the procedure 4-11 d later .


Four timed voids ( morning , afternoon , evening , overnight ) were selected from each 24-h collection .


We developed gender-specific equations to calibrate total sodium excreted in each of the one-void ( e.g. , morning ) and combined two-void ( e.g. , morning + afternoon ) urines to 24-h sodium excretion .


The calibrated sodium excretions were used to estimate the population distribution of usual 24-h sodium excretion .


Participants were then randomly assigned to modeling ( n = 160 ) or validation ( n = 247 ) groups to examine the bias in estimated population percentiles .


Median bias in predicting selected percentiles ( 5th , 25th , 50th , 75th , 95th ) of usual 24-h sodium excretion with one-void urines ranged from -367 to 284 mg ( -7.7 to 12.2 % of the observed usual excretions ) for men and -604 to 486 mg ( -14.6 to 23.7 % ) for women , and with two-void urines from -338 to 263 mg ( -6.9 to 10.4 % ) and -166 to 153 mg ( -4.1 to 8.1 % ) , respectively .


Four of the 6 two-void urine combinations produced no significant bias in predicting selected percentiles .


Our approach to estimate the population usual 24-h sodium excretion , which uses calibrated timed-void sodium to account for day-to-day variation and covariance between measurement errors , produced percentile estimates with relatively low biases across low-to-high sodium excretions .


This may provide a low-burden , low-cost alternative to 24-h collections in monitoring population sodium intake among healthy young adults and merits further investigation in other population subgroups .


To observe the clinical curative effect of Chinese medicine Bushen Huoxue Granule ( , BHG ) on Parkinson 's disease ( PD ) patients with depressive state .


Sixty-two PD patients with depressive state were randomly assigned to two groups by using a random number table , 31 in each group .


Madopar was given to all as the conventional treatment .


The fluoxetine hydrochloride dispersible tablet was given to the patients in the control group and BHG was given to those in the treatment group .


The therapeutic course for all was 12 weeks .


Before and after treatment , Hamilton depression rating scale ( HAMD ) was applied to judge the curative effect , and the changes of cerebral neurotransmitters levels in the brain of patients were detected by encephalofluctuograph technique .


The scores of HAMD in the two groups were decreased markedly after 12-week treatment .


It was lower in the treatment group than that in the control group with significant difference ( P < 0.01 ) .


The contents of norepinephrine ( NE ) and 5-serotonin ( 5-HT ) in the PD patients were obviously lower than normal value .


There was no significant difference between the two groups before treatment ( P > 0.05 ) .


The contents of NE and 5-HT were all increased in the two groups after treatment ( P < 0.05 ) , with significant differences between the two groups ( P < 0.01 ) .


BHG could increase the contents of NE and 5-HT in PD patients ' brain to improve the depressive state of PD patients .


The optimum model of physiotherapy service delivery for maximizing active task practice during rehabilitation after stroke is unknown .


The purpose of the study was to examine the relative effectiveness of 2 alternative models of physiotherapy service delivery against a usual care control with regard to increasing patient activity .


Substudy within a large 3-armed randomized controlled trial , which compared 3 different models of physiotherapy service delivery , was provided for 4 weeks during subacute , inpatient rehabilitation ( n = 283 ) .


The duration of all physiotherapy sessions was recorded .


In addition , 32 participants were observed at 10-minute intervals for 1 weekday and 1 weekend day between 8:00 am and 4:30 pm .


At each observation , we recorded physical activity , location , and people present .


Participants receiving 7-day-week and circuit class therapy received an additional 3 hours and 22 hours of physiotherapy time , respectively , when compared with usual care .


Participants were standing or walking for a median of 8.2 % of observations .


On weekdays , circuit class therapy participants spent more time in therapy-related activity ( 10.2 % of observations ) when compared with usual care participants ( 6.1 % of observations ) .


On weekends , 7-day therapy participants spent more time in therapy-related activity ( 4.2 % of observations ) when compared with both usual care and circuit class therapy participants ( 0 % of observations for both groups ) .


Activity levels outside of therapy sessions did not differ between groups .


A greater dosage of physiotherapy time did not translate into meaningful increases in physical activity across the day .


http://www.anzctr.org.au/ .


Unique identifier : ACTRN12610000096055 .


Repetitive transcranial magnetic stimulation ( rTMS ) of the left dorsolateral-prefrontal cortex ( DLPFC ) exerts antidepressant effects .


In this randomised controlled clinical trial we aimed to test the safety and therapeutic efficacy of bilateral theta-burst stimulation ( TBS ) as an add-on therapy to standard treatment of major depression .


Fifty-six patients diagnosed with a moderate to severe depressive episode received 15 daily treatments of either rTMS ( 110 % motor-threshold ; rightDLPFC , 1000 stimuli at 1 Hz + leftDLPFC , 1000 stimuli at 10 Hz ) , theta-burst stimulation ( 80 % motor-threshold ; rightDLPFC , continuous TBS , 1200 stimuli + leftDLPFC , intermittent TBS , 1200 stimuli ) , or sham TMS ( N = 17 , sham coil with the TBS protocol ) .


There was no significant effect in the primary outcome measures ( change of the 21-item Hamilton Rating Scale for Depression ) .


However , there was a tendency towards an increased responder rate at the end of the follow-up period for both active treatments as compared to sham , and this tendency was most pronounced for the TBS group .


This pilot study did not reveal significant advantages of bilateral TBS or rTMS over sham treatment as an add-on treatment for major depression .


A tendency towards a superior effect of bilateral TBS at the end of the follow-up period may warrant further studies .


This study aimed to assess the dose and volume effects of suppository preparations and safety of NRL001 ( one of four possible stereoisomers of methoxamine hydrochloride ) on anal sphincter tone using rectal suppositories in healthy adult volunteers .


This was a Phase I , single-centre , randomised , double-blind , three-way crossover study during which subjects received three single doses of 1 g rectal suppositories ( containing 5 or 10 mg NRL001 or matching placebo ) or 2 g rectal suppositories ( containing 10 or 15 mg NRL001 or matching placebo ) on three separate dosing days .


The outcome measures were mean anal resting pressure ( MARP ) variables ( monitored continuously for 20-30 min before and up to 6 h after dosing ) , pharmacokinetics ( PK ) and safety assessments .


Twenty-six subjects were dosed with study medication .


Two subjects were withdrawn prematurely and were not included in the main analysis .


There was a dose-dependent increase in anal sphincter tone ( MARP ) when comparing the 5 and 10 mg doses of NRL001 ; however , the 15 mg dose did not have a significantly greater effect than the 10 mg dose .


Suppository size ( 1 or 2 g ) did not appear to have an effect on sphincter tone .


There was no evidence against dose proportionality for the PK variables , but the mean maximum plasma concentration ( Cmax ) for the 1 g suppository group was higher than for the 2 g group .


Twenty-one adverse events were reported in 8 ( 30.8 % ) subjects .


A dose dependent decrease in heart rate was noted ; however , there were no adverse events reported that were related to this reduction in heart rate .


The increase in anal sphincter tone supports the potential therapeutic use of NRL001 in treating faecal incontinence , with further studies in patients required .


NRL001 was well tolerated in single doses of up to 15 mg .


Depression and anxiety are associated with adverse cardiovascular outcomes in patients with recent acute cardiac events .


There has been minimal study of collaborative care ( CC ) management models for mental health disorders in high-risk cardiac inpatients , and no prior CC intervention has simultaneously managed depression and anxiety disorders .


To determine the impact of a low-intensity CC intervention for depression , generalized anxiety disorder , and panic disorder among patients hospitalized for an acute cardiac illness .


Single-blind randomized clinical trial , with study assessors blind to group assignment , from September 2010 through July 2013 of 183 patients admitted to inpatient cardiac units in an urban academic general hospital for acute coronary syndrome , arrhythmia , or heart failure and found to have clinical depression , generalized anxiety disorder , or panic disorder on structured assessment .


Participants were randomized to 24 weeks of a low-intensity telephone-based multicomponent CC intervention targeting depression and anxiety disorders ( n = 92 ) or to enhanced usual care ( serial notification of primary medical providers ; n = 91 ) .


The CC intervention used a social work care manager to coordinate assessment and stepped care of psychiatric conditions and to provide support and therapeutic interventions as appropriate .


Improvement in mental health-related quality of life ( Short Form-12 Mental Component Score [ SF-12 MCS ] ) at 24 weeks , compared between groups using a random-effects model in an intent-to-treat analysis .


Patients randomized to CC had significantly greater estimated mean improvements in SF-12 MCS at 24 weeks ( 11.21 points [ from 34.21 to 45.42 ] in the CC group vs 5.53 points [ from 36.30 to 41.83 ] in the control group ; estimated mean difference , 5.68 points [ 95 % CI , 2.14-9 .22 ] ; P = .002 ; effect size , 0.61 ) .


Patients receiving CC also had significant improvements in depressive symptoms and general functioning , and higher rates of treatment of a mental health disorder ; anxiety scores , rates of disorder response , and adherence did not differ between groups .


A novel telephone-based , low-intensity model to concurrently manage cardiac patients with depression and/or anxiety disorders was effective for improving mental health-related quality of life in a 24-week trial .


clinicaltrials.gov Identifier : NCT01201967 .


There are conflicting results on the impact of anxiety on depression outcomes .


The impact of anxiety has not been studied in major depression with psychotic features ( `` psychotic depression '' ) .


We assessed the impact of specific anxiety symptoms and disorders on the outcomes of psychotic depression .


We analyzed data from the Study of Pharmacotherapy for Psychotic Depression that randomized 259 younger and older participants to either olanzapine plus placebo or olanzapine plus sertraline .


We assessed the impact of specific anxiety symptoms from the Brief Psychiatric Rating Scale ( `` tension '' , `` anxiety '' and `` somatic concerns '' and a composite anxiety score ) and diagnoses ( panic disorder and GAD ) on psychotic depression outcomes using linear or logistic regression .


Age , gender , education and benzodiazepine use ( at baseline and end ) were included as covariates .


Anxiety symptoms at baseline and anxiety disorder diagnoses differentially impacted outcomes .


On adjusted linear regression there was an association between improvement in depressive symptoms and both baseline `` tension '' ( coefficient = 0.784 ; 95 % CI : 0.169-1 .400 ; p = 0.013 ) and the composite anxiety score ( regression coefficient = 0.348 ; 95 % CI : 0.064-0 .632 ; p = 0.017 ) .


There was an interaction between `` tension '' and treatment group , with better responses in those randomized to combination treatment if they had high baseline anxiety scores ( coefficient = 1.309 ; 95 % CI : 0.105-2 .514 ; p = 0.033 ) .


In contrast , panic disorder was associated with worse clinical outcomes ( coefficient = -3.858 ; 95 % CI : -7.281 to -0.434 ; p = 0.027 ) regardless of treatment .


Our results suggest that analysis of the impact of anxiety on depression outcome needs to differentiate psychic and somatic symptoms .


To evaluate the feasibility and appropriateness of a prehospital system allowing ambulance nurses to transport older adults directly to geriatric care at a community-based hospital ( CH ) or to an emergency department ( ED ) .


Randomized controlled trial .


Emergency medical services in Stockholm , Sweden .


Older adults who called the emergency number were randomized to an intervention group ( n = 410 ) or a control group ( n = 396 ) .


The dispatcher randomized the individuals .


Those randomized to the intervention group were transported to several alternative destinations decided by a trained nurse performing a comprehensive assessment , using the new prehospital system .


Those randomized to the control group were transported to the ED .


Primary endpoint : number of individuals triaged directly to a CH ( feasibility ) .


Secondary endpoint : number of subsequent transfers ( appropriateness ) from CH to ED within 24 hours after initial admission .


After exclusion and crossover , the control group consisted of 217 and the intervention group of 449 older adults .


The nurse sent 20 % of the intervention group ( 90/449 ) ( 95 % confidence interval ( CI ) = 16.6-24 .0 ) directly to the CH when using the prehospital system .


Six of those individuals ( 6.7 % ) ( 95 % CI = 3.1-13 .8 ) were subsequently transferred from the CH to the ED .


Overall , the nurse appropriately triaged 93.3 % of the participants ( 84/90 ) and transferred them to the CH , avoiding an ED visit .


Ambulance nurses are able to send older adults to an alternative healthcare facility with the help of a prehospital decision support system .


In this geographical setting , this appears to be a promising method to optimize resources and improve emergency care of elderly adults .


The culture in many team sports involves consumption of large amounts of alcohol after training/competition .


The effect of such a practice on recovery processes underlying protein turnover in human skeletal muscle are unknown .


We determined the effect of alcohol intake on rates of myofibrillar protein synthesis ( MPS ) following strenuous exercise with carbohydrate ( CHO ) or protein ingestion .


In a randomized cross-over design , 8 physically active males completed three experimental trials comprising resistance exercise ( 85 reps leg extension , 80 % 1 repetition maximum ) followed by continuous ( 30 min , 63 % peak power output ( PPO ) ) and high intensity interval ( 1030 s , 110 % PPO ) cycling .