We conducted post hoc ( secondary ) analyses of unpublished data from a previously published randomized clinical trial ( NCT00477490 ) of desmopressin ( a medication used to treat nocturia ) and examined relationships between baseline and 4-week change in FUSP and PSQI global and subscale scores for participants ( N = 580 to N = 606 ) having complete data .


Data indicated strong associations between change in PSQI global score and FUSP change in six of seven subscale scores .


A reduction of 1.8 points in the PSQI global score was associated with a 72-min lengthening of FUSP .


Results suggest that FUSP is a potentially valuable metric that correlates with changes in perceived sleep duration , depth , quality for the entire night , efficiency , latency , and daytime function .


An increase in FUSP was related to improvement in nearly all PSQI subscales .


The validity of this measure in the general population remains to be determined .


To evaluate the impact of a diet and physical activity intervention ( BeWEL ) on weight change in people with a body mass index > 25 weight ( kg ) / height ( m ) ( 2 ) at increased risk of colorectal cancer and other obesity related comorbidities .


Multicentre , parallel group , randomised controlled trial .


Four Scottish National Health Service health boards .


329 overweight or obese adults ( aged 50 to 74 years ) who had undergone colonoscopy after a positive faecal occult blood test result , as part of the national bowel screening programme , and had a diagnosis of adenoma confirmed by histopathology .


163 were randomised to intervention and 166 to control .


Participants were randomised to a control group ( weight loss booklet only ) or 12 month intervention group ( three face to face visits with a lifestyle counsellor plus monthly 15 minute telephone calls ) .


A goal of 7 % reduction in body weight was set and participants received a personalised energy prescription ( 2508 kJ ( 600 kcal ) below that required for weight maintenance ) and bodyweight scales .


Motivational interviewing techniques explored self assessed confidence , ambivalence , and personal values concerning weight .


Behavioural strategies included goal setting , identifying intentions of implementation , self monitoring of body weight , and counsellor feedback about reported diet , physical activity , and weight change .


The primary outcome was weight change over 12 months .


Secondary outcomes included changes in waist circumference , blood pressure , fasting cardiovascular biomarkers , and glucose metabolism variables , physical activity , diet , and alcohol consumption .


At 12 months , data on the primary outcome were available for 148 ( 91 % ) participants in the intervention group and 157 ( 95 % ) in the control group .


Mean weight loss was 3.50 kg ( SD 4.91 ) ( 95 % confidence interval 2.70 to 4.30 ) in the intervention group compared with 0.78 kg ( SD 3.77 ) ( 0.19 to 1.38 ) in the control group .


The group difference was 2.69 kg ( 95 % confidence interval 1.70 to 3.67 ) .


Differences between groups were significant for waist circumference , body mass index , blood pressure , blood glucose level , diet , and physical activity .


No reported adverse events were considered to be related to trial participation .


Significant weight loss can be achieved by a diet and physical activity intervention initiated within a national colorectal cancer screening programme , offering considerable potential for risk reduction of disease in older adults .


Current Controlled Trials ISRCTN53033856 .


We tested the hypothesis that warm-humidified carbon dioxide ( CO2 ) insufflation would reduce postoperative pain and morphine requirement compared to cold-dry CO2 insufflation .


A double-blinded , randomized , controlled trial was conducted to compare warm , humidified CO2 and cold-dry CO2 .


Patients with benign uterine diseases were randomized to either treatment ( n = 48 ) or control ( n = 49 ) group during laparoscopically assisted vaginal hysterectomy .


Primary endpoints of the study were rest pain , movement pain , shoulder-tip pain , and cough pain at 2 , 4 , 6 , 24 , and 48 hours postoperatively , measured by visual analogue scale .


Secondary outcomes were morphine consumption , rejected boli , temperature change , recovery room stay , and length of hospital stay .


There were no significant differences in all baseline characteristics .


Shoulder-tip pain at 6 h postoperatively was significantly reduced in the intervention group .


Pain at rest , movement pain , and cough pain did not differ .


Total morphine consumption and rejected boli at 24 h postoperatively were significantly higher in the control group .


Temperature change , recovery room stay , and length of hospital were similar .


Warm , humidified insufflation gas significantly reduces postoperative shoulder-tip pain as well as morphine demand .


This trial is registered with Clinical Trial Registration Number DRKS00003853 ( German Clinical Trials Register ( DRKS ) ) .


Research indicates that the chronic consumption of flavonoids is associated with cognitive benefits in adults with mild cognitive impairment and neurodegenerative disease , although to our knowledge , there have been no such studies in healthy older adults .


Furthermore , the effects of commonly consumed orange juice flavanones on cognitive function remain unexplored .


We investigated whether 8 wk of daily flavanone-rich orange juice consumption was beneficial for cognitive function in healthy older adults .


High-flavanone ( 305 mg ) 100 % orange juice and an equicaloric low-flavanone ( 37 mg ) orange-flavored cordial ( 500 mL ) were consumed daily for 8 wk by 37 healthy older adults ( mean age : 67 y ) according to a crossover , double-blind , randomized design separated by a 4-wk washout .


Cognitive function , mood , and blood pressure were assessed at baseline and follow-up by using standardized validated tests .


Global cognitive function was significantly better after 8-wk consumption of flavanone-rich juice than after 8-wk consumption of the low-flavanone control .


No significant effects on mood or blood pressure were observed .


Chronic daily consumption of flavanone-rich 100 % orange juice over 8 wk is beneficial for cognitive function in healthy older adults .


The potential for flavanone-rich foods and drinks to attenuate cognitive decline in aging and the mechanisms that underlie these effects should be investigated .


Computer-delivered interventions have the potential to improve access to quality addiction treatment care .


The objective of this study was to evaluate the effectiveness of the Therapeutic Education System ( TES ) , an Internet-delivered behavioral intervention that includes motivational incentives , as a clinician-extender in the treatment of substance use disorders .


Adult men and women ( N = 507 ) entering 10 outpatient addiction treatment programs were randomly assigned to receive 12 weeks of either treatment as usual ( N = 252 ) or treatment as usual plus TES , with the intervention substituting for about 2 hours of standard care per week ( N = 255 ) .


TES consists of 62 computerized interactive modules covering skills for achieving and maintaining abstinence , plus prize-based motivational incentives contingent on abstinence and treatment adherence .


Treatment as usual consisted of individual and group counseling at the participating programs .


The primary outcome measures were abstinence from drugs and heavy drinking ( measured by twice-weekly urine drug screens and self-report ) and time to dropout from treatment .


Compared with patients in the treatment-as-usual group , those in the TES group had a lower dropout rate ( hazard ratio = 0.72 , 95 % CI = 0.57 , 0.92 ) and a greater abstinence rate ( odds ratio = 1.62 , 95 % CI = 1.12 , 2.35 ) .


This effect was more pronounced among patients who had a positive urine drug or breath alcohol screen at study entry ( N = 228 ) ( odds ratio = 2.18 , 95 % CI = 1.30 , 3.68 ) .


Internet-delivered interventions such as TES have the potential to expand access and improve addiction treatment outcomes .


Additional research is needed to assess effectiveness in non-specialty clinical settings and to differentiate the effects of the community reinforcement approach and contingency management components of TES .


Statins improve overall outcomes after noncardiac surgery .


The primary aim of the study was to determine whether use of perioperative atorvastatin reduced the rate of postoperative complications in patients undergoing pulmonary resection .


This was a prospective , randomized , placebo-controlled , double-blind trial of patients undergoing elective pulmonary resection who received atorvastatin ( 40 mg daily ) or placebo beginning 1 week before surgery and continued for 1 week postoperatively .


Patient characteristics and postoperative complications were recorded .


Plasma inflammatory markers were sampled at baseline , in the post-anesthesia care unit , and on postoperative day 3 .


Because of difficulty enrolling statin-naive patients , the study was stopped at the interim analysis .


Postoperative complications occurred in 16 of 72 patients ( 22 % ) receiving placebo and in 8 of 65 patients ( 12 % ) receiving atorvastatin ( P = .13 ) .


For patients undergoing major anatomic resection , there were 24 complications in 15 of 45 placebo-treated patients and 8 complications in 7 of 43 atorvastatin-treated patients ( P = .04 ) .


Plasma levels of C-reactive protein , tumor necrosis factor - , and myeloperoxidase did not differ between the 2 treatment arms during the study .


After a 2-week perioperative course of atorvastatin ( 40 mg ) in statin-nave patients undergoing major pulmonary resection , we found evidence of a reduction in the number of clinically important cardiovascular and pulmonary complications compared with placebo .


These promising results merit evaluation in a larger , perhaps multicenter study .


Skin graft donor sites are notoriously painful , with potential complications of fluid loss , delayed healing , infection , and hypertrophic scarring , particularly in patients with burns or traumatic injury .


In this population , rapid epithelialization is critical to reducing morbidity and cost .


This prospective , randomized controlled trial compared the effects of 40-kHz noncontact low-frequency ultrasound ( NLFU ) in addition to standard care ( SC ) with SC alone in subjects with split-thickness donor sites of 20 to 200 cm ( 2 ) .


Standard care consisted of cleansing and moist wound dressings .


Outcomes measured were time to healing , defined as absence of drainage and full epithelialization ; pain and itching scores ; and recidivism rates .


Of 33 patients enrolled ; 27 were randomized and received a minimum of 4 study treatments .


Median age was 49 years , 69 % were male , and 84 % were burn patients .


Comorbidities included hypertension ( 31 % ) , coronary artery disease ( 22 % ) , pulmonary disease ( 38 % ) , anemia ( 31 % ) , and diabetes ( 16 % ) .


Median donor site area was 136.0 cm ( 2 ) .


Noncontact low-frequency ultrasound and SC compared with SC demonstrated a mean time to heal of 12.1 days vs 21.3 days ( p = 0.04 ) .


All NLFU+SC subjects had epithelialized by 4 weeks compared with only 71 % in SC .


Recidivism rates were 8 % for NLFU+SC compared with 45 % for SC .


Pain scores were reduced and significant differences in itching were observed .


Noncontact low-frequency ultrasound and SC compared with SC alone in the treatment of split-thickness donor sites demonstrated significant accelerated healing and reduced pain and itching .


Noncontact low-frequency ultrasound subjects experienced a better quality of healing with less incidence of infection and recidivism .


The aim of this analysis was to compare the effects of 2 atypical antipsychotic agents , lurasidone ( 80 mg/d or 160 mg/d ) and quetiapine XR ( 600 mg/d ) , on daytime alertness , and to evaluate the effects of daytime sleepiness on treatment outcomes in patients with an acute exacerbation of schizophrenia .


Patients who met Diagnostic and Statistical Manual of Mental Disorders , 4th edition , text revision ( DSM-IV-TR ) criteria for schizophrenia were randomized to 6 weeks of double-blind treatment with fixed doses of lurasidone 80 mg/d ( n = 125 ) , lurasidone 160 mg/d ( n = 121 ) , quetiapine XR 600 mg/d ( n = 119 ) , or placebo ( n = 121 ) , all dosed once daily in the evening , with food .


Daytime sleepiness was assessed using the Epworth Sleepiness Scale ( ESS ) .


Daytime sleepiness improved in the lurasidone and placebo-treated groups but worsened in the quetiapine XR treatment group when compared to placebo ( p = 0.001 ) and to either dose of lurasidone ( both p < 0.01 ) .


Sedation associated with quetiapine XR treatment mediated an improvement in agitation [ assessed by the Positive and Negative Syndrome Scale-Excitement ( PANSS-EC ) subscale ] and a worsening in functional capacity [ assessed by the University of California-San Diego ( UCSD ) Performance-Based Skills Assessment-Brief Version ( UPSA-B ) total score ] ; these mediating relationships were not observed for the lurasidone or placebo treatment groups .


In this 6-week double-blind study , treatment with lurasidone 80 mg or 160 mg , administered once daily in the evening , was associated with a reduction in daytime sleepiness similar in magnitude to placebo , while quetiapine XR 600 mg/d was associated with a significant increase in daytime sleepiness , compared to both lurasidone dose groups and placebo .


Daytime sleepiness was associated with improvement in agitation and worsening in functional capacity for quetiapine XR , but not lurasidone or placebo-treated patients .


Distal upper limb pain ( pain affecting the elbow , forearm , wrist , or hand ) can be non-specific , or can arise from specific musculoskeletal disorders .


It is clinically important and costly , the best approach to clinical management is unclear .


Physiotherapy is the standard treatment and , while awaiting treatment , advice is often given to rest and avoid strenuous activities , but there is no evidence base to support these strategies .


This paper describes the protocol of a randomised controlled trial to determine , among patients awaiting physiotherapy for distal arm pain , ( a ) whether advice to remain active and maintain usual activities results in a long-term reduction in arm pain and disability , compared with advice to rest ; and ( b ) whether immediate physiotherapy results in a long-term reduction in arm pain and disability , compared with physiotherapy delivered after a seven week waiting list period .


Between January 2012 and January 2014 , new referrals to 14 out-patient physiotherapy departments were screened for potential eligibility .


Eligible and consenting patients were randomly allocated to one of the following three groups in equal numbers : 1 ) advice to remain active , 2 ) advice to rest , 3 ) immediate physiotherapy .


Patients were and followed up at 6 , 13 , and 26 weeks post-randomisation by self-complete postal questionnaire and , at six weeks , patients who had not received physiotherapy were offered it at this time .


The primary outcome is the proportion of patients free of disability at 26 weeks , as determined by the modified DASH ( Disabilities of the Arm , Shoulder and Hand ) questionnaire.We hypothesise ( a ) that advice to maintain usual activities while awaiting physiotherapy will be superior than advice to rest the arm ; and ( b ) that fast-track physiotherapy will be superior to normal ( waiting list ) physiotherapy .


These hypotheses will be examined using an intention-to-treat analysis .


Results from this trial will contribute to the evidence base underpinning the clinical management of patients with distal upper limb pain , and in particular , will provide guidance on whether they should be advised to rest the arm or remain active within the limits imposed by their symptoms .


Registered on http://www.controlled-trials.com ( reference number : ISRCTN79085082 ) .


This study evaluated the efficacy of a probiotic containing Bacillus toyonensis spores ( Toyocerin ( ) ) in postweaning piglets against enteric pathogens .


Seven hundred and ninety-two healthy weaning pigs of a commercial farrow-to-finish pig farm were used .


The negative control group fed without Toyocerin ( ) and two experimental groups fed similar to the negative control group , but supplemented with Toyocerin ( ) at t 500 mg kg ( -1 ) diet ( Toyocerin 500 group ) and 1000 mg kg ( -1 ) diet ( Toyocerin 1000 group ) , respectively .


No significant difference ( P > 0.05 ) in morbidity and mortality rate between groups was noticed .


The Toyocerin groups showed higher body weight ( P < 0.05 ) and lower feed conversion ratio compared to the negative control group .


Diarrhoea score was less in both Toyocerin groups than negative control group ( P < 0.05 ) .


Moreover , the use of Toyocerin ( ) at 1000 mg kg ( -1 ) diet resulted in higher average daily feed intake compared to other groups ( P < 0.05 ) , reduction of some enteric pathogens and increase of the number of lactic acid bacteria .


The use of Toyocerin ( ) in weaning pigs , especially at 1000 mg kg ( -1 ) diet , improved their health and growth performance .


This study shows that a feed additive containing B. toyonensis ( Toyocerin ( ) ) protects against enteric pathogens in postweaning piglets when fed this additive at a proper dose .


The use of Toyocerin ( ) at 1000 mg kg ( -1 ) diet resulted in higher average daily feed intake , decrease of some enteric pathogens and higher number of lactic acid bacteria .


The effect of the probiotic in other age groups remains to be established .


Inhalation of thermal water with antioxidant properties is empirically used for COPD .


To evaluate the effects of sulphurous thermal water ( reducing agents ) on airway oxidant stress and clinical outcomes in COPD .


Forty moderate-to-severe COPD patients were randomly assigned to receive 12-day inhalation with sulphurous thermal water or isotonic saline .


Patients were assessed for superoxide anion ( O2 ( - ) ) production in the exhaled breath condensate and clinical outcomes at recruitment , the day after the conclusion of the 12-day inhalation treatment , and one month after the end of the inhalation treatment .


Inhalation of reducing agents resulted in a significant reduction of O2 ( - ) production in exhaled breath condensate of COPD patients at the end of the inhalatory treatment and at followup compared to baseline .


A significant improvement in the COPD assessment test ( CAT ) questionnaire was shown one month after the end of the inhalatory treatment only in patients receiving sulphurous water .


Thermal water inhalation produced an in vivo antioxidant effect and improvement in health status in COPD patients .


Larger studies are required in order to evaluate whether inhalation of thermal water is able to modify relevant clinical outcomes of the disease ( the study was registered at clinicaltrial.gov-identifier : NCT01664767 ) .


The phase III BEYOND trial was undertaken to confirm in a Chinese patient population the efficacy seen with first-line bevacizumab plus platinum doublet chemotherapy in globally conducted studies .


Patients age 18 years with locally advanced , metastatic , or recurrent advanced nonsquamous non-small-cell lung cancer ( NSCLC ) were randomly assigned to receive carboplatin ( area under the curve , 6 ) intravenously and paclitaxel ( 175 mg/m ( 2 ) ) intravenously ( CP ) on day 1 of each 3-week cycle , for six cycles , plus placebo ( Pl + CP ) or bevacizumab ( B+CP ) 15 mg/kg intravenously , on day 1 of each cycle , until progression , unacceptable toxicity , or death .


The primary end point was progression-free survival ( PFS ) ; secondary end points were objective response rate , overall survival , exploratory biomarkers , safety .


A total of 276 patients were randomly assigned , 138 to each arm .


PFS was prolonged with B+CP versus Pl + CP ( median , 9.2 v 6.5 months , respectively ; hazard ratio [ HR ] , 0.40 ; 95 % CI , 0.29 to 0.54 ; P < .001 ) .


Objective response rate was improved with B+CP compared with Pl + CP ( 54 % v 26 % , respectively ) .


Overall survival was also prolonged with B+CP compared with Pl + CP ( median , 24.3 v 17.7 months , respectively ; HR , 0.68 ; 95 % CI , 0.50 to 0.93 ; P = .0154 ) .


Median PFS was 12.4 months with B+CP and 7.9 months with Pl + CP ( HR , 0.27 ; 95 % CI , 0.12 to 0.63 ) in EGFR mutation-positive tumors and 8.3 and 5.6 months , respectively ( HR , 0.33 ; 95 % CI , 0.21 to 0.53 ) , in wild-type tumors .


Safety was similar to previous studies of B+CP in NSCLC ; no new safety signals were observed .


The addition to bevacizumab to carboplatin/paclitaxel was well tolerated and resulted in a clinically meaningful treatment benefit in Chinese patients with advanced nonsquamous NSCLC .


The aim of this study was to assess the effects of the Dietary Approaches to Stop Hypertension ( DASH ) diet on lipid profiles and biomarkers of oxidative stress in overweight and obese women with polycystic ovary syndrome ( PCOS ) .


This randomized controlled clinical trial was conducted with 48 women diagnosed withPCOS .


The women were randomly assigned to consume either the control ( n = 24 ) or DASH diet ( n = 24 ) for 8 wk .


Both diets were designed to be calorie-restricted .


Both diets consisted of 52 % carbohydrates , 18 % proteins , and 30 % total fats .


The DASH diet was designed to be rich in fruits , vegetables , whole grains , and low-fat dairy products and to be low in saturated fats , cholesterol , and refined grains .


Fasting blood samples were taken at baseline and after 8-wk intervention to measure lipid profiles and biomarkers of oxidative stress including plasma total antioxidant capacity ( TAC ) and total glutathione ( GSH ) .


Adherence to the DASH diet , compared with the control diet , resulted in a significant decrease in weight ( -4.4 versus -1.5 kg ; P < 0.001 ) and body mass index ( -1.7 versus -0.6 kg/m ( 2 ) ; P < 0.001 ) , decreased serum triglycerides ( -10.0 versus +19.2 mg/dL ; P interaction = 0.005 ) and very-low-density lipoprotein cholesterol levels ( -2.0 versus +3.9 mg/dL ; P interaction = 0.005 ) .


Increased concentrations of TAC ( +98.6 versus -174.8 mmol/L ; P interaction < 0.001 ) and GSH ( +66.4 versus -155.6 mol/L ; P interaction = 0.005 ) also were found in the DASH group compared with the control group .


Consumption of DASH diet for 8 wk led to a significant reduction in serum insulin , triglycerides and very-low-density lipoprotein cholesterol and a significant increase in TAC and GSH levels .


To describe the implementation process of a birth preparation program , the activities in the protocol for physical and birth preparation exercises , and the educational activities that have been evaluated regarding effectiveness and women 's satisfaction .


The birth preparation program described was developed with the following objectives : to prevent lumbopelvic pain , urinary incontinence and anxiety ; to encourage the practice of physical activity during pregnancy and of positions and exercises for non-pharmacological pain relief during labor ; and to discuss information that would help women to have autonomy during labor .


The program comprised the following activities : supervised physical exercise , relaxation exercises , and educational activities ( explanations of lumbopelvic pain prevention , pelvic floor function , labor and delivery , and which non-pharmacological pain relief to use during labor ) provided regularly after prenatal consultations .


These activities were held monthly , starting when the women joined the program at 18-24 weeks of pregnancy and continuing until 30 weeks of pregnancy , fortnightly thereafter from 31 to 36 weeks of pregnancy , and then weekly from the 37th week until delivery .


Information and printed materials regarding the physical exercises to be performed at home were provided .


Clinicaltrials.gov : NCT01155804 .


The program was an innovative type of intervention that systematized birth preparation activities that were organized to encompass aspects related both to pregnancy and to labor and that included physical , educational and home-based activities .


The detailed description of the protocol used may serve as a basis for further studies and also for the implementation of birth preparation programs within the healthcare system in different settings .


Hemodialysis ( HD ) patients are educated and counseled during the HD procedure .


There are few studies assessing whether cognitive performance varies with dialysis .


Using a randomized cross-over design , 40 patients were assigned to one of two sequences : testing 1 h before dialysis followed 1 month later by testing during the first hour of dialysis ( n = 21 ) versus testing during the first hour of dialysis followed 1 month later by 1 h before dialysis ( n = 19 ) .


Cognitive tests were administered at each testing period .


Mixed regression models evaluated for a dialysis effect ( difference between test performance before vs. during dialysis ) while adjusting for potential learning ( difference between first and second tests ) .


In models accounting for period of testing , there was no difference in test performance between 1 h before versus during the first hour of HD for all administered cognitive tests ( p > 0.05 ) .


A learning effect was detected between first and second test administration in two tests , specifically , the Word List Learning and the Digit Symbol Substitution Test .


We found no difference in cognitive performance depending on the time of testing , suggesting that cognitive tests performed during the first hour of dialysis are a valid assessment of cognitive performance .


Increases to radiotherapy dose are constrained by normal tissue effects .


The relationship between bowel dose volume data and late bowel toxicity in patients with muscle-invasive bladder cancer treated with radical radiotherapy was assessed .


The bowel was contoured retrospectively on radiotherapy plans of 47 patients recruited to the BC2001 trial ( CRUK/01/004 ) .


The relationship between bowel volume at various dose levels and prospectively collected late bowel toxicity was explored .


Fifteen per cent and 6 % of patients experienced grade 1 and grade 2 or more late bowel toxicity , respectively .


The mean bowel volume was significantly less at doses 50 Gy in those treated with reduced high dose volume radiotherapy compared with standard radiotherapy .


The probability of late bowel toxicity increased as bowel volume increased ( P 0.05 for dose levels 30-50 Gy ) .


No grade 2 or more late bowel toxicity was observed in patients with bowel volumes under the thresholds given in the model that predict for 25 % probability of late bowel toxicity .


There is a dose volume effect for late bowel toxicity in radical bladder radiotherapy .


We have modelled the probability of late bowel toxicity from absolute bowel volumes to guide clinicians in assessing radical bladder radiotherapy plans .


Thresholds predicting for a 25 % probability of late bowel toxicity are proposed as dose volume constraints .


Questions remain regarding the consequences of illicit drug use on adolescent adjustment and the nature of mechanisms that may explain these consequences .


In this study , we examined whether early-onset illicit drug use predicts subsequent academic and psychosocial adjustment and whether associations are socially-mediated by decreased school engagement and increased peer deviancy .


4885 adolescents were followed throughout secondary school .


We used regressions to determine whether illicit drug use in grade 7 predicted academic achievement , school dropout , depressive symptoms , and conduct problems in grades 10-11 , adjusting for potential confounders .


We used path analysis to test whether significant associations were mediated by school engagement and peer deviancy in grade 8 .


Illicit drug use predicted conduct problems and school dropout , but not academic achievement and depressive symptoms .


The association between illicit drug use and conduct problems was fully mediated by increased peer deviancy .


The association between illicit drug use and school dropout was partially mediated by increased peer deviancy , but remained mostly direct .


No indirect association via decreased school engagement was found .


Examination of reverse pathways revealed that conduct problems and academic achievement in grade 7 predicted drug use in grades 10-11 .


These associations were mediated by peer deviancy and school engagement ( conduct problems only ) .


Adolescent illicit drug use influences the risk of school dropout and conduct problems in part by contributing to deviant peer affiliation .


Reciprocal social mediation characterizes the association between drug use and conduct problems .


A reverse mechanism best explains the association with academic achievement .


Cough is one of the most common reasons why children visit a health care professional .


To compare the effect of a novel formulation of pasteurized agave nectar vs placebo and no treatment on nocturnal cough and the sleep difficulty associated with nonspecific acute cough in infants and toddlers .


In this randomized clinical trial performed in 2 university-affiliated outpatient , general pediatric practices from January 28 , 2013 , through February 28 , 2014 , children 2 to 47 months old with nonspecific acute cough duration of 7 days or less were studied .


Surveys were administered to parents on 2 consecutive days , the day of presentation ( when no medication had been given the prior evening ) and the next day ( when agave nectar , placebo , or no treatment had been administered to their child before bedtime ) according to a partially double-blind randomization scheme .


A single dose of agave nectar , placebo , or no treatment administered 30 minutes before bedtime .


Cough frequency , cough severity , cough bothersomeness , congestion severity , rhinorrhea severity , and cough effect on child and parent sleep .


Significant differences in symptom improvement were detected between the study groups ( P < .05 for all , except P = .06 for cough bothersomeness ) , with agave nectar and placebo proving to be superior to no treatment , but no significant differences for any outcome were found when comparing agave nectar against placebo .


In a comparison of agave nectar , placebo , and no treatment , a placebo effect was demonstrated , with no additional benefit offered by agave nectar .


Health care professionals should consider the potential benefits and costs when recommending a treatment with only a placebo effect for infants and toddlers with nonspecific acute cough .


clinicaltrials.gov Identifier : NCT01721395 .


Drug effects on the function of smell and taste are occasionally mentioned in prescription information however , most originate from anecdotal reports without even distinguishing between gustatory or olfactory deteriorations .


This includes the antifungal fluconazole .


In a randomized , placebo-controlled , double-blind , two-way crossover study , 12 healthy men and 9 healthy women ( age 26.8 3.7 years ) took oral doses of 400 mg fluconazole or placebo once daily for 8 days .


Gustatory and olfactory functions were tested before and after the treatment using clinically validated tests ( `` Taste Strips '' and `` Sniffin ' Sticks '' , respectively ) .


Baseline taste scores of 12.3 2.2 and 12.5 1.7 for the fluconazole and placebo conditions , respectively , corresponded to normative values .


Similarly , baseline ( pretreatment ) composite olfactory TDI scores ( odor `` threshold discrimination identification '' ) of 35.0 3.2 and 35.7 4.3 for men and 34.8 4.2 and 35.5 2.8 for women during the fluconazole or placebo conditions , respectively , corresponded to normative values .


Neither gustation nor olfaction was significantly affected by the fluconazole treatment .


The present study provided a negative result regarding fluconazole effects contrasting , for example , with those of sildenafil in a comparatively powered study [ 1 ] .


Up to the tested dose of 400 mg/d , fluconazole does not have general and reproducible effects on taste and smell in healthy humans .


However , it was unlikely to detect rare disturbances with the present study cohort size , and , therefore , rare fluconazole side effects on human chemosensation , as occasionally reported , remain a possibility .


To assess the efficacy and safety of latanoprostene bunod ( LBN ) compared with latanoprost 0.005 % , and to determine the optimum drug concentration ( s ) of LBN in reducing intraocular pressure ( IOP ) in subjects with open angle glaucoma or ocular hypertension .


Randomised , investigator-masked , parallel-group , dose-ranging study .


Subjects instilled one drop of study medication in the study eye once daily each evening for 28days and completed five study visits .


The primary efficacy endpoint was the reduction in mean diurnal IOP at Day 28 .


Of the 413 subjects randomised ( LBN 0.006 % , n = 82 ; LBN 0.012 % , n = 85 ; LBN 0.024 % , n = 83 ; LBN 0.040 % , n = 81 ; latanoprost , n = 82 ) , 396 subjects completed the study .


Efficacy for LBN was dose-dependent reaching a plateau at 0.024 % -0.040 % .


LBN 0.024 % led to significantly greater reductions in diurnal IOP compared with latanoprost at the primary endpoint , Day 28 ( p = 0.005 ) , as well as Days 7 ( p = 0.033 ) and 14 ( p = 0.015 ) .


The incidence of adverse events , mostly mild and transient , was numerically higher in the LBN treatment groups compared with the latanoprost group .


Hyperaemia was similar across treatments .


LBN 0.024 % dosed once daily was the lower of the two most effective concentrations evaluated , with significantly greater IOP lowering and comparable side effects relative to latanoprost 0.005 % .


LBN dosed once daily for 28days was well tolerated .


NCT01223378 .


Injury is the number one cause of death and disability in children in the United States and an increasingly important public health problem globally .


While prevention of injuries is an important goal , prevention efforts are currently fragmented , poorly funded , and rarely studied .


Among school-aged children , pedestrian crashes are a major mechanism of injury .


We hypothesized that we could develop a game-based educational tool that would be effective in teaching elementary school children the principles of pedestrian safety .


Between November 2011 and June 2013 , second - and third-grade children in Los Angeles Unified School District were randomly assigned to play a unique interactive video game ( Ace 's Adventure ) about pedestrian safety or to a traditional didactic session about pedestrian safety .


A pretest and posttest were administered to the study participants .


Afterward , study participants were observed for appropriate pedestrian behavior on a simulated street set called Street Smarts .


All statistical analyses were performed using SAS version 9.2 .


A total of 348 study participants took the pretest and posttest .


There were 180 who were randomized to the didactic and 168 who were randomized to the video game .


The didactic group demonstrated a higher mean score increase ( 1.01 , p < 0.0001 ) as compared with the video game group ( 0.44 , p < 0.0001 ) .


However , observation of study participants revealed that participants who played the video game , as compared with the didactic group , more frequently exhibited appropriate behavior during the following : exiting a parked car ( p = 0.01 ) , signaling to a car that was backing up ( p = 0.01 ) , signaling to a stopped car ( p = 0.0002 ) , and crossing the street ( p = 0.01 ) .


Students who played the educational video game about pedestrian safety performed similarly to those who attended a more traditional and labor-intensive didactic learning .


Innovative educational methods , such as game playing , could significantly change our approach to injury prevention and have the potential to decrease the burden of injury among children worldwide .


Little is known about duration of protection after the infant primary series of hepatitis B ( HB ) vaccine in settings of low HB endemicity .


This study sought to determine the proportion of adolescents immunized as infants who had protective titers of antibody to hepatitis B surface antigen ( anti-HBs ) before and after a challenge dose of vaccine .


US-born 16 - through 19-year-olds who received a recombinant HB vaccine 3-dose series initiated within 7 days of birth ( group 1 ) or at 4 weeks of age ( group 2 ) and completed by 12 months of age were enrolled .


Participants had serologic testing before and 2 weeks after randomization to receive a challenge dose of 10 g or 20 g of Engerix-B .


Baseline and postchallenge levels of anti-HBs were compared by group , challenge dosage , and demographic and behavioral characteristics .


At baseline , 24 % had protective anti-HBs levels of 10 IU/mL ; 92 % achieved protective levels after challenge dose .


Although group 1 had a lower proportion of seroprotection at baseline , group and challenge dosage were not associated with postchallenge proportion of seroprotection .


Being in group 2 , higher test dosage , higher baseline geometric mean titer , and nonwhite race were associated with significantly higher geometric mean titer after challenge dose .


More than 90 % of study participants immunized against HB as infants exhibited a seroprotective response to a challenge dose of vaccine .


Duration of protection from the primary infant HB vaccine series extended through the adolescent years in the setting of low HB endemicity .


To investigate the accuracy of measuring intraocular pressure over a silicone hydrogel contact lens using Goldmann applanation tonometry in eyes with glaucoma .


This was a prospective , randomized study and enrolled 28 patients ( 28 right eyes ) with primary open angle glaucoma .


Intraocular pressure was taken with and without a silicone hydrogel contact lens ( -0.50 D ) , in situ ( using Goldmann applanation tonometry ) , in a randomized order of measurements .


Statistical analysis was performed using paired t-test and Bland-Altman plot .


The mean difference ( standard deviation ) found between intraocular pressure measurement without ( mean 16.7 3.2 mmHg ) and with ( mean 17.3 3.0 mmHg ) contact lens was found to be -0.57 2.3 mmHg ( 95 % confidence interval , -1.5 to 0.3 ) .


No significant statistical difference was found between the two groups with paired t-test ( p = 0.19 ) .


The Bland Altman plot showed some evidence of increasing variability of differences between two measures of intraocular pressure , with increasing intraocular pressure .


The 95 % limits of agreement of the Bland Altman plot were unacceptably large ( -5 mmHg to 3.9 mmHg ) .


Agreement between Goldmann applanation tonometry with and without contact lenses seems to be poor in patients with glaucoma , especially for high intraocular pressure .


8-Hydroxy-2 ,2,14,14 - tetramethylpentadecanedioic acid ( ETC-1002 ) is a small molecule with a unique mechanism of action shown in nonclinical studies to modulate pathways of cholesterol , fatty acid , and carbohydrate metabolism .


In previous phase 2 clinical trials , once daily oral treatment with ETC-1002 significantly reduced low-density lipoprotein-cholesterol in patients with hypercholesterolemia .


In this trial , the lipid-lowering efficacy of ETC-1002 was evaluated in patients with type 2 diabetes mellitus and hypercholesterolemia .


Additional cardiometabolic biomarkers , including glycemic measures , were also assessed .


A single-center , double-blind , placebo-controlled trial evaluated 60 patients with type 2 diabetes mellitus and elevated low-density lipoprotein-cholesterol .


Patients discontinued all diabetes mellitus and lipid-regulating drugs and were randomized to receive ETC-1002 80 mg QD for 2 weeks followed by 120 mg QD for 2 weeks or placebo for 4 weeks .


ETC-1002 lowered low-density lipoprotein-cholesterol levels by 432.6 % ( least squares meanSE ) , compared with a reduction of 42.5 % by placebo at day 29 ( P < 0.0001 ; primary end point ) .


Non-high-density lipoprotein-cholesterol and total cholesterol were also significantly lowered by ETC-1002 compared with placebo ( P < 0.0001 ) .


High-sensitivity C-reactive protein was reduced by 41 % ( median ) compared with a placebo reduction of 11 % ( P = 0.0011 ) .


No clinically meaningful safety findings were observed .


ETC-1002 lowered low-density lipoprotein-cholesterol and other lipids and demonstrated improvement in high-sensitivity C-reactive protein in patients with type 2 diabetes mellitus and hypercholesterolemia without worsening glycemic control .


ETC-1002 was well tolerated in this population .


http://www.clinicaltrials.gov .


Unique identifier : NCT # 01607294 .


To evaluate the therapeutic effect of topical unoprostone isopropyl ( unoprostone ) on patients with retinitis pigmentosa ( RP ) .


Forty patients with typical forms of RP were included in the study.Seventeen of 40 patients were treated with 0.12 % topical unoprostone twice daily in a randomly selected eye .


Patients underwent follow-up examinations every 3 months after treatment .


The efficacy of the treatment was monitored by visual acuity and visual field measurement testing using the Humphrey Field Analyzer ( HFA : the central 10-2 programme ) .


Moreover , 12 RP patients who were included this study and 12 normal subjects were evaluated in terms of their macular blood flow of both eyes after instillation of unoprostone using the laser speckle method .


One year after treatment , the ` macular sensitivity ' , calculated by HFA as the average sensitivity of the central 12 points , was preserved in the fellow eyes as well as the unoprostone-treated eyes .


On the other hand , that in the eyes of the control RP patient was significantly decreased .


Moreover , there were significantly greater improvements of the ` macular sensitivity ' in the unoprostone-treated eyes than the fellow eyes .


The change ratios of macular blood flow obtained from both RP patients and normal subjects were significantly increased in both the treated and the fellow eyes .


No severe side-effects were observed .


These results demonstrate that topical unoprostone might have a therapeutic efficacy in patients with RP as a consequence of the macular bloodflow improvement as well as its direct neuroprotective effect .


Ginger is one of the most commonly used herbal medicines for irritable bowel syndrome ( IBS ) but no data exists about its effectiveness .


Double blind randomized controlled trial .


University of North Carolina , Chapel Hill , North Carolina , USA .


Forty-five IBS patients were randomly assigned to three groups : placebo , 1g of ginger , and 2g of ginger daily for 28 days .


The IBS severity scale ( IBS-SS ) was administered , as well as adequate relief of symptoms scale .


A responder was defined as having at least 25 % reduction in IBS-SS post-treatment .


There were 57.1 % responders to placebo , 46.7 % to 1g and 33.3 % to 2g of ginger .


Adequate relief was reported by 53.3 % on placebo and 53.3 % in both ginger groups combined .


Side effects were mild and reported by 35.7 % in the placebo and 16.7 % in the ginger groups .


This double blind randomized controlled pilot study suggests ginger is well tolerated but did not perform better than placebo .


Larger trials are needed before any definitive conclusions can be drawn .


The aim of this study was to conduct a cluster randomized control trial to assess the efficacy of screening and brief intervention ( SBI ) for conjoint alcohol and tobacco use among hospital out-patients .


In all 620 hospital out-patients who screened positive for both tobacco and alcohol moderate risk in four hospitals were randomized into 2 control and 1 intervention condition using the hospital as a unit of randomization ( 2 intervention and 2 control hospitals ) to 405 patients in the two control groups ( tobacco only intervention , n = 199 , and alcohol only intervention , n = 206 ) and 215 in the intervention group .


The intervention or control consisted of three counselling sessions .


Results of the interaction ( GroupTime ) effects using GEE indicated that there were statistically significant differences between the three study groups over the 6-month follow-up on the ASSIST tobacco score ( Wald ( 2 ) = 8.43 , P = 0.004 ) , and past week tobacco use abstinence ( Wald ( 2 ) = 7.34 , P = 0.007 ) .


Although there were no significant interaction effects on the other outcomes ( Alcohol ASSIST score , low alcohol risk score , past week tobacco abstinence or low alcohol risk score , and past week tobacco abstinence and low alcohol risk score ) , the scores in all of the six outcome measures showed consistent improvements .


For past week tobacco abstinence the tobacco only intervention was more effective than the alcohol only intervention and the integrated alcohol and tobacco intervention .


For the outcome of low alcohol risk , the alcohol only intervention and the integrated alcohol and tobacco intervention was more effective than the tobacco only or alcohol only intervention .


The study found that for past week tobacco abstinence the tobacco only intervention was more effective than the alcohol only intervention and the polydrug use ( alcohol and tobacco ) integrated intervention .


To compare the effects of two physical therapy exercise in-hospital programs in pulmonary function and functional capacity of patients in the postoperative period of heart transplantation .


Twenty-two heart transplanted patients were randomized to the control group ( CG , n = 11 ) and training group ( TG , n = 11 ) .


The control group conducted the exercise program adopted as routine in the institution and the training group has had a protocol consisting of 10 stages , with incremental exercises : breathing exercises , resistance training , stretching and walking .


The programs began on the first day after extubation and stretched until hospital discharge .


Assessed pulmonary function , distance walked in six minutes walk test ( 6MWT ) and peripheral muscle strength by one repetition maximum test ( 1RM ) .


Similar behavior was observed between the two groups treated , with statistically significant increases between the first and second test of the following variables : FVC ( 59 % in CG and 35.2 % in TG ) ; MIP ( 8.6 % in CG and 53.5 % in TG ) , MEP ( 28.8 % in CG and 40.7 % in TG ) and 6MWT ( 44.5 % in CG and 31.4 % in TG ) .


There was an increase of peripheral strength by 1RM test , over time , to the muscle groups of the elbow flexors , shoulder flexors , hip abductors and knee flexors .


Heart transplant patients benefit from exercise programs in hospital , regardless of the program type applied .


A new training proposal did not result in superiority compared to routine programme applied .


Exercise protocols provided improves in ventilatory variables and functional capacity of this population .


Chronic neck/shoulder pain ( CNSP ) is one of the most common pain conditions .


The understanding of mechanisms , including the peripheral balance between nociceptive and antinociceptive processes , is incomplete .


N-acylethanolamines ( NAEs ) are a class of endogenous compounds that regulate inflammation and pain .


The aim of this study was to investigate the levels of two NAEs : the peroxisome proliferator-activated receptor type - ligand palmitoylethanolamide ( PEA ) and stearoylethanolamide ( SEA ) in the muscle interstitium of the trapezius muscle in women with CNSP randomized to two different neck specific training programs and in a healthy pain-free control group ( CON ) .


Fifty-seven women with CNSP were randomized to strength + stretch or stretch alone exercise programs .


Twenty-nine subjects underwent microdialysis procedure before and after 4-6 months of exercise .


Twenty-four CON subjects underwent microdialysis procedure before and after 4-6 months without any intervention in between .


Microdialysate samples were collected from the trapezius muscle and analyzed by mass spectrometry for PEA and SEA levels .


PEA and SEA levels were significantly higher in CNSP patients compared with CON .


PEA was significantly higher in CNSP than in CON after both training programs .


SEA was significantly higher in CNSP than in CON after stretch alone but not after strength + stretch training .


A significant positive correlation was found between changes in pain intensity and in SEA levels in the strength + stretch group , but not in the stretch alone group .


Our results indicate that exercise interventions differentially affect the levels of the bioactive lipids PEA and SEA in the interstitium of the trapezius muscle in women with CNSP .


To examine safety , tolerability , and efficacy of PF-04494700 , an inhibitor of the receptor for advanced glycation end products ( RAGE ) , in mild to moderate Alzheimer disease ( AD ) .


Double-blind , placebo-controlled trial at 40 academic centers ( United States ) .


Subjects with AD and Mini-Mental State Examination score 14-26 were randomized to PF-04494700 60 mg/day 6 days , then 20 mg daily ( high dose ) ; 15 mg/day 6 days , then 5 mg daily ( low dose ) ; or placebo , for 18 months .


Clinical and laboratory measures were used to evaluate safety and tolerability .


The primary efficacy measure was the Alzheimer 's Disease Assessment Scale-cognitive ( ADAS-cog ) .


Secondary measures assessed clinical stage , function , behavior , MRI , and CSF biomarkers .


A total of 399 subjects were randomized .


In a prespecified interim analysis , when 50 % of subjects had completed the 6-month visit , the high dose was associated with confusion , falls , and greater ADAS-cog decline and was discontinued .


A second prespecified analysis compared low-dose and placebo groups for futility and safety approximately 12 months after all subjects were randomized .


This analysis met criteria for futility , and treatment was discontinued .


There were no safety concerns in the low-dose group .


Analyses including post-futility data showed decreased decline on the ADAS-cog in the low-dose group at month 18 .


Other clinical and biomarker measures showed no differences between low-dose treatment and placebo .


PF-04494700 at 20 mg/d was associated with increased adverse events and cognitive decline .


At 5 mg/d , PF-04494700 had a good safety profile .


A potential benefit for this low dose on the ADAS-cog is not conclusive , because of high dropout and discontinuation rates subsequent to the interim analyses .


This study provides Class I evidence that in patients with AD high-dose PF-04494700 increased cognitive decline at 6 months and Class IV evidence that low-dose PF-04494700 slowed cognitive decline at 18 months .


To investigate the effects of trimetazidine on renal function in patients with shock .


A prospective randomized controlled double-blind study was conducted .


128 patients with shock admitted to intensive care unit ( ICU ) of Guangzhou Red Cross Hospital from April 2011 to April 2013 were enrolled and randomly divided into control group and trimetazidine treatment group , each n = 64 .


All patients received anti-shock treatment , while the patients in trimetazidine group received trimetazidine treatment ( 20 mg orally , tid ) for 7 days , and patients in control group received placebo ( 10 mL of sterile water for injection , tid ) for 7 days .


The urinary output , serum creatinine ( SCr ) , blood urea nitrogen ( BUN ) , cystatin C , and creatinine clearance ( CCr ) reflecting renal function were recorded in both groups , and the values were compared before treatment , 48 hours after treatment , and 1 week after the treatment .


At the same time , dynamic mean arterial pressure ( MAP ) was monitored , and 48-hour and 1-week mortality rates were recorded .


There was no significant difference in results in all the renal function parameters before the treatment between two groups .


The levels of SCr , BUN , cystatin C were gradually decreased after treatment in both groups , but CCr and MAP were gradually increased .


Compared with the control group , cystatin C at 48 hours after treatment was significantly decreased , while CCr was significantly increased in treatment group ( cystatin C : 0.850.81 mg/L vs. 1.010.91 mg/L , t = 2.562 , P = 0.017 ; CCr : 0.930.64 mL/s vs. 0.690.40 mL/s , t = 2.155 , P = 0.033 ) .


SCr and BUN at 1 week after treatment were significantly decreased in treatment group ( SCr : 94.2388.31 mol/L vs. 104.9998.37 mol/L , t = 2.921 , P = 0.003 ; BUN : 9.468.24 mmol/L vs. 11.878.65 mmol/L , t = 2.611 , P = 0.010 ) .


Urine output per hour and MAP was improved after treatment in both groups , and no significant difference was found between treatment group and control group ( urine output : 48 hours after treatment 55.6731.43 mL vs. 45.3411.79 mL , t = 0.934 , P = 0.323 ; 1 week after treatment 71.6737.23 mL vs. 75.3522.88 mL , t = 1.280 , P = 0.210 ; MAP : 48 hours after treatment 72.1333.24 mmHg vs. 69.2839.98 mmHg , t = 1.408 , P = 0.179 ; 1 week after treatment 71.4421.98 mmHg vs. 72.3231.11 mmHg , t = 1.184 , P = 0.252 ] .


Mortality rate in treatment group was lowered compared with control group , however no statistical significance was found [ 48 hours after treatment : 31.2 % ( 20/64 ) vs. 32.8 % ( 21/64 ) , 2 = 0.084 , P = 0.785 ; 1 week after treatment : 32.8 % ( 21/64 ) vs. 35.9 % ( 23/64 ) , 2 = 2.084 , P = 0.173 ] .


Trimetazidine can improve renal function in patients with shock .


The aim of this study is to compare the effects of sevoflurane and propofol on one lung ventilation ( OLV ) induced ischemia-reperfusion injury ( IRI ) by determining the blood gas , ischemia-modified albumin ( IMA ) , and malonyldialdehyde ( MDA ) .


Forty-four patients undergoing thoracic surgery with OLV were randomized in two groups ( sevoflurane Group S , propofol Group P ) .


Anesthesia was inducted with thiopental and was maintained with 1-2 .5 % of sevoflurane within the 40/60 % of O2/N2O mixture in Group S.


In Group P anesthesia was inducted with propofol and was maintained with infusion of propofol and remifentanil .


Hemodynamic records and blood samples were obtained before anesthesia induction ( t 1 ) , 1 min before two lung ventilation ( t 2 ) , 30 min after two lung ventilation ( t 3 ) , and postoperative sixth hours ( t 4 ) .


Heart rate at t 2 and t 3 in Group P was significantly lower than that in Group S.


While there were no significant differences in terms of pH and pCO2 , pO2 at t 2 and t 3 in Group S was significantly lower than that in Group P. IMA levels at t 4 in Group S were significantly lower than those in Group P.


Sevoflurane may offer protection against IRI after OLV in thoracic surgery .


The Low Molecular Weight Fraction of 5 % human serum Albumin ( LMWF-5A ) is being investigated as a treatment for knee pain from osteoarthritis .


This was a multicenter randomized , vehicle-controlled , double-blind , parallel study designed to evaluate the safety and efficacy of two doses of an intra-articular injection of LMWF-5A .


Patients with symptomatic knee osteoarthritis were randomized 1111 to receive a single 4 mL or 10 mL intra-articular knee injection of either LMWF-5A or vehicle control ( saline ) .


The primary efficacy endpoint was the difference between treatment groups in the Western Ontario and McMaster Universities ( WOMAC ) pain change from baseline over 12 weeks .


Safety was examined as the incidence and severity of adverse events ( AEs ) .


A total of 329 patients were randomized and received treatment .


LMWF-5A resulted in a significant decrease in pain at 12 weeks compared to vehicle control ( -0.93 vs -0.72 ; estimated difference from control : -0.25 , p = 0.004 ) ; an injection volume effect was not observed ( p = 0.64 ) .


The effect of LMWF-5A on pain was even more pronounced in patients with severe knee OA ( Kellgren Lawrence Grade IV ) : the estimated difference from control was -0.42 ( p = 0.02 ) .


Adverse events were generally mild and were similar in patients who received vehicle control ( 47 % ) and LMWF-5A ( 41 % ) .


This clinical trial demonstrated that LMWF-5A is safe and effective at providing relief for the pain of moderate to severe OA of the knee over 12 weeks when administered by intra-articular injection into the knee .


ClinicalTrials.gov NCT01839331 .


Severe childhood obesity has become a major health problem , and effective , evidence-based interventions are needed .


The relative effectiveness of inpatient compared with ambulatory treatment remains unknown .


To determine whether an inpatient treatment program is more effective than an ambulatory treatment program at achieving a sustained weight loss in children and adolescents with severe obesity .


We conducted a randomized clinical trial with a 2-year follow-up at a tertiary referral center for pediatric obesity in the Netherlands .


We recruited 90 children and adolescents aged 8 to 18 years with severe obesity ( body mass index [ BMI ] z score , 3.0 or > 2.3 with obesity-related health problems ) .


Patients were randomly assigned to an inpatient ( 6 months of hospitalization on working days ) or an ambulatory ( 12 days of hospital visits at increasing intervals during a 6-month period ) treatment program .


Both treatment programs involved an intensive , family-based , lifestyle intervention , including exercise , nutritional education , and behavior modification for the patients and their caregiver ( s ) .


Change in BMI z score .


Secondary outcomes included fasting insulin , fasting plasma glucose , 2-hour plasma glucose , and lipid levels , insulin sensitivity , liver function test results , waist circumference , blood pressure , body composition , and aerobic fitness ( peak oxygen consumption , Vo ) .


Outcomes were analyzed by intention to treat .


Immediately after treatment , reductions in the BMI z score were significantly larger for the inpatient than the ambulatory groups ( mean [ SE ] difference , -0.26 [ 0.12 ; 95 % CI , -0.59 to -0.01 ] ; P = .04 ) .


Change from baseline for the BMI z score in the inpatient group was -18.0 % ( P = .001 ) immediately after treatment , -8.5 % ( P = .008 ) at 18 months , and -6.3 % ( P = .38 ) at 30 months ; in the ambulatory group , changes from baseline were -10.5 % ( P = .001 ) , -6.2 % ( P = .39 ) , and -1.5 % ( P > .99 ) , respectively .


The favorable outcomes of the inpatient group could not be sustained at 12 and 24 months after treatment .


In addition , significant differences in favor of the inpatient group immediately after treatment were found for levels of fasting insulin ( -6.37 IU/L ; P = .02 ) , total cholesterol ( -19.51 mg/dL ; P = .01 ) , low-density lipoprotein cholesterol ( -13.48 mg/dL ; P = .03 ) , and triglycerides ( -25.39 mg/dL ; P = .01 ) , and insulin sensitivity ( -1.37 ; P = .02 ) , fat mass ( -3.31 % ; P = .03 ) , and peak Vo ( 378.2 mL/min ; P = .01 ) .


In severely obese children and adolescents , inpatient treatment was superior to ambulatory treatment immediately after treatment , but effects were not sustained at long-term follow-up .


These findings stress the need to further study maintenance strategies for sustainable weight loss .


trialregister.nl Identifier : NTR1172 .


To determine the efficacy of topical ketorolac tromethamine in preventing cystoid macular edema ( CME ) after uncomplicated cataract surgery .


This single-center , prospective , double-masked , randomized clinical trial consisted of 81 patients who were scheduled for cataract surgery .


Patients were randomized to receive hypromellose/dextran 70 as a placebo ( n = 44 ) or ketorolac tromethamine 0.4 % ( n = 37 ) as an adjuvant therapy .


These eye drops were administered 4 times daily ( QID ) for 3 days before surgery and 5 weeks postoperatively .


All patients received prednisolone acetate 1 % QID during the same period as basal/standard anti-inflammatory therapy .


The primary outcome was the incidence of angiographic CME 5 weeks after surgery .


The secondary outcomes were mean change in best-corrected visual acuity ( BCVA ) [ Early Treatment Diabetic Retinopathy study ( ETDRS ) ] , clinical CME incidence , intraocular pressure , and retinal thickness measured using optical coherence tomography ( OCT ) .


In the placebo group , 2/44 ( 4.5 % ) patients and in the ketorolac group , 2/37 ( 5.4 % ) patients presented with angiographic CME ( P = 0.624 ) .


The mean change in postoperative BCVA was 3215 letters in the placebo group and 2616 letters in the ketorolac group ( P = 0.07 ) .


There were no statistically significant between-group differences in the mean central subfield thickness ( P = 0.679 ) , minimal central thickness ( P = 0.352 ) , or central macular volume ( P = 0.729 ) .


There was no difference between ketorolac tromethamine and a placebo with regard to BCVA results or prevention of CME after uncomplicated cataract surgery .


Several pre - and intraoperative factors have been associated with incisional surgical site infection ( SSI ) , but little is known about the influence of postoperative wound care and especially , the use of different dressings on incisional SSI .


The aim of this study was to compare 3 methods of wound dressings ( conventional dressing , silver-containing dressing , and mupirocin ointment dressing ) for their ability to prevent SSI , as measured by SSI rates , in patients with colorectal cancer undergoing elective open surgery .


A prospective , randomized study was performed .


Inclusion criteria were diagnosis of colorectal neoplasms and plans to undergo elective surgery with curative aims .


Patients were randomized using a 1:1:1 allocation into 3 groups : patients receiving an ionic silver-containing dressing ( ISD ) ( group 1 ) , a mupirocin ointment application ( MOA ) ( group 2 ) , and a conventional dressing ( group 3 or standard dressing ) .


The primary outcomes variable was occurrence of incisional SSI .


Follow-up was 30 days postoperatively .


A total of 147 patients were included , 49 in each group .


Incisional SSI occurred in 9 patients ( 18.4 % ) in the ISD group , 2 ( 4.1 % ) in the MOA group , and 10 ( 20.4 % ) in the standard dressing group ( p = 0.028 ) .


Adjusting for multiple comparisons , there were no significant differences between ISD and standard dressing groups ; a significant difference was observed between ISD and MOA ( relative risk [ RR ] 4.5 ; 95 % CI ( 1.1 to 19.8 ) ; p = 0.046 ) and between the standard group and the MOA group ( RR 5 ; 95 % CI ( 1.2 to 21.7 ) ; p = 0.031 ) .


Topical application of mupirocin ointment achieves better results for the prevention of SSI than ionic silver-containing dressing or standard dressing in patients undergoing elective open colorectal surgery .


It is assumed that laparoscopic surgery generally induces less inflammatory responses than open surgery .


Since few studies have compared immune responses after laparoscopic and open surgery in children , we examined inflammatory markers in children randomized to open ( ONF ) or laparoscopic Nissen fundoplication ( LNF ) .


Blood samples were collected prior to surgery ( D0 ) , and on postoperative day 1 ( D1 ) and day 2 ( D2 ) .


Inflammatory markers were measured using a multiplex antibody bead kit .


The postoperative levels of inflammatory markers were statistically analyzed using a linear mixed model .


A P value < 0.05 was considered statistically significant .


Twenty-nine patients randomized to ONF or LNF were included .


Median age was 3.1 years ( range 1.0-14 .2 ) in the ONF group and 4.0 years ( range 0.2-14 .2 ) in the LNF group .


Plasma levels of the anti-inflammatory cytokine interleukin ( IL ) -10 were significantly higher in the ONF group than in the LNF group postoperatively ( P = 0.04 ) .


However , there were no significant differences between the groups in the levels of pro-inflammatory markers tumor necrosis factor - , IL-6 , IL-8 , monocyte chemoattractant protein-1 , white blood cell count , or C-reactive protein .


We did not find that laparoscopy induced a substantially less inflammatory response than laparotomy in children undergoing fundoplication .


To assess the feasibility and efficacy of a novel , minimally invasive spinal surgery technique for the correction of lumbar spinal stenosis involving unilateral approach for bilateral decompression .


Cross-sectional observational study .


Neurosurgery Department of PGMI , Lady Reading Hospital , Peshawar , from January to December 2010 .


A total of 60 patients with lumbar stenosis were randomly assigned to undergo either a conventional laminectomy ( 30 patients , Group A ) , or a unilateral approach ( 30 patients , Group B ) .


Clinical outcomes was measured using the scale of Finneson and Cooper .


All the data was collected by using a proforma and different parameters were assessed for a minimum follow-up period of three months .


Data was analyzed by descriptive statistics using SPSS software version 17 .


Adequate decompression was achieved in all patients .


Compared with patients in the conventional laminectomy group , patients who received the novel procedure ( unilateral approach ) had a reduced mean duration of hospital stay , a faster recovery rate and majority of the patients ( 88.33 % ) had an excellent to fair operative result according to the Finneson and Cooper scale .


Five major complications occurred in all patient groups , 2 patients had unintended dural rent and 2 wound dehiscence each and fifth patient had worsening of symptoms .


There was no mortality in the series .


The ultimate goal of the unilateral approach to treat lumbar spinal stenosis is to achieve adequate decompression of the neural elements .


An additional benefit of a minimally invasive approach is adequate preservation of vertebral stability , as it requires only minimal muscle trauma , preservation of supraspinous/intraspinous ligament complex and spinous process , therefore , allows early mobilization .


This also shortens the hospital stay , reduces postoperative back pain , and leads to satisfactory outcome .


Fatigue is a distressing symptom occurring in more than 60 % of patients with cancer .


The CNS stimulants modafinil and methylphenidate are recommended for the treatment of cancer-related fatigue , despite a limited evidence base .


We aimed to evaluate the efficacy and tolerability of modafinil in the management of fatigue in patients with non-small-cell lung cancer ( NSCLC ) .


Adults with advanced NSCLC and performance status of 0 to 2 , who were not treated with chemotherapy or radiotherapy within the last 4 weeks , were randomly assigned to daily modafinil ( 100 mg on days 1 to 14 ; 200 mg on days 15 to 28 ) or matched placebo .


The primary outcome was change in Functional Assessment of Chronic Illness Therapy ( FACIT ) - Fatigue score from baseline to 28 days , adjusted for baseline fatigue and performance status .


Secondary outcomes included safety and patient-reported measures of depression , daytime sleepiness , and quality of life .


A total of 208 patients were randomly assigned , and 160 patients ( modafinil , n = 75 ; placebo , n = 85 ) completed questionnaires at both baseline and day 28 and were included in the modified intention-to-treat analysis .


FACIT-Fatigue scores improved from baseline to day 28 ( mean score change : modafinil , 5.29 ; 95 % CI , 2.57 to 8.02 ; placebo , 5.09 ; 95 % CI , 2.54 to 7.65 ) , but there was no difference between treatments ( 0.20 ; 95 % CI , -3.56 to 3.97 ) .


There was also no difference between treatments for the secondary outcomes ; 47 % of the modafinil group and 23 % of the placebo group stated that the intervention was not helpful .


Modafinil had no effect on cancer-related fatigue and should not be prescribed outside a clinical trial setting .


Its use was associated with a clinically significant placebo effect .


To observe the clinical efficacy of Bushen Huoxue Sanyu Decoction ( BHSD ) in treatment of adenomyosis ( AM ) patients .


Seventy AM patients of Shen deficiency blood stasis syndrome ( SDBSS ) were randomly assigned to two groups , the CM treatment group ( 50 cases ) and the Mirena group ( 20 cases ) .


Patients in the CM treatment group were treated with BHSD , one dose per day .


Levonorgestrel intrauterine system ( Mirena ) was placed in the uterine cavity of those in the Mirena group .


The therapeutic course for all was 3 months .


Changes of dysmenorrhea , menstrual quantity , SDBSS , CM syndrome , uterine volume , and serum CA125 levels were observed before and after treatment .


Compared with before treatment in the same group , scores for dysmenorrhea integral , scores for menstrual quantity , scores for SDBSS , and scores for CM syndrome all decreased in the two groups after treatment ( P < 0.01 ) .


Compared with before treatment in the same group , the uterine volume was reduced after treatment in the two groups ( P < 0.05 ) and serum carbohydrate antigen CA125 levels decreased between the two groups ( P < 0.05 , P < 0.01 ) .


Compared with the Mirena group , scores for dysmenorrhea integral increased and scores for SDBSS decreased in the CM treatment group ( P < 0.01 , P < 0.05 ) .


There was no statistical difference in the uterine volume or serum carbohydrate antigen CA125 levels ( P > 0.05 ) .


BHSD could effectively alleviate main symptoms of AM patients of QSBSS such as dysmenorrhea , profuse menstrual blood volume , and increased uterine volume , and lower scores for QSBSS and the total score for CM syndrome .


Effective measures are needed to prevent methicillin-resistant Staphylococcus aureus ( MRSA ) skin and soft tissue infections ( SSTIs ) in high-risk community settings .


The study objective was to evaluate the effect of personal hygiene-based strategies on rates of overall SSTI and MRSA SSTI .


We conducted a prospective , field-based , cluster-randomized trial in US Army Infantry trainees from May 2010 through January 2012 .


There were 3 study groups with incrementally increased education and hygiene-based interventions : standard ( S ) , enhanced standard ( ES ) , and chlorhexidine ( CHG ) .


The primary endpoints were incidence of overall SSTI and MRSA SSTI .


The study included 30 209 trainees constituting 540 platoons ( 168 S , 192 ES , and 180 CHG ) .


A total of 1203 ( 4 % ) participants developed SSTI , 316 ( 26 % ) due to MRSA .


The overall SSTI rate was 4.15 ( 95 % confidence interval [ CI ] , 3.77-4 .58 ) per 100 person-cycles .


SSTI rates by study group were 3.48 ( 95 % CI , 2.87-4 .22 ) for S , 4.18 ( 95 % CI , 3.56-4 .90 ) for ES , and 4.71 ( 95 % CI , 4.03-5 .50 ) for CHG .


The MRSA SSTI rate per 100 person-cycles for all groups was 1.10 ( 95 % CI , .91 -1.32 ) .


MRSA SSTI rates by study group were 1.0 ( 95 % CI , .70 -1.42 ) for S , 1.29 ( 95 % CI , .98 -1.71 ) for ES , and 0.97 ( 95 % CI , .70 -1.36 ) for CHG .


Personal hygiene and education measures , including once-weekly use of chlorhexidine body wash , did not prevent overall SSTI or MRSA SSTI in a high-risk population of military trainees .


NCT01105767 .


The growing incidence of infections caused by Enterobacteriaceae producing ESBLs has led to increased use of carbapenems .


Temocillin , which resists most - lactamases , may be a useful alternative .


The aim of this study was to assess the pharmacokinetics and target attainment rates of 6 g of temocillin daily divided into three administrations every 8 h ( three times daily ) or administered by continuous infusion in critically ill patients .


This was a prospective , two-centre , randomized , controlled study in patients with intra-abdominal or lower respiratory tract infections caused by Enterobacteriaceae .


Thirty-two patients were included and analysed for clinical efficacy , and pharmacokinetics were measured in 29 of them .


Four patients undergoing continuous veno-venous haemofiltration ( CVVH ) were analysed separately .


Mean , median and range of percentages of the dosing interval during which the free drug concentration remained > 16 mg/L were 76.4 , 98 and 18.7-98 .9 in patients treated three times daily and 98.9 , 89.7 and 36.4-99 .9 in patients with continuous infusion , respectively .


Clinical cure rates were 79 % and 93 % in each of these groups , respectively ( not significant ) .


Patients with CVVH received a daily dose of 750 mg given by continuous infusion and had a mean free drug concentration of only 13.81.9 mg/L .


No adverse event attributable to temocillin was observed .


Temocillin ( 6 g daily ) given by continuous infusion allows a larger proportion of critically ill patients to have free drug serum concentrations covering infections caused by Enterobacteriaceae with an MIC of 16 mg/L compared with administration three times daily .


Clinical efficacy compared with carbapenems in documented severe infections needs to be further studied .


Tourniquet application is still a common practice in total knee arthroplasty ( TKA ) surgery despite being associated with several adverse effects .


We evaluated the effects of tourniquet use on functional and clinical outcome and on knee range of motion ( ROM ) .


70 patients who underwent TKA were randomized into a tourniquet group ( n = 35 ) and a non-tourniquet group ( n = 35 ) .


All operations were performed by the same surgeon and follow-up was for 1 year .


Primary outcomes were functional and clinical outcomes , as evaluated by KOOS and knee ROM .


Secondary outcomes were intraoperative blood loss , surgical time and visibility , postoperative pain , analgesic consumption , and transfusion requirements .


Patients in the non-tourniquet group showed a better outcome in all KOOS subscores and better early knee ROM from surgery to week 8 .


No difference was detected at the 6 - and 12-month follow-ups .


Postoperative pain and analgesic consumption were less when a tourniquet was not used .


Surgical time and visibility were similar between groups .


Intraoperative blood loss was greater when not using a tourniquet , but no postoperative transfusions were required .


This study shows that TKA without the use of a tourniquet results in faster recovery in terms of better functional outcome and improved knee ROM .


Furthermore , reduced pain and analgesic use were registered and no intraoperative difficulties were encountered .


Countries in sub-Saharan Africa ( SSA ) are experiencing an epidemic of cardiovascular disease ( CVD ) propelled by rapidly increasing rates of hypertension .


Barriers to hypertension control in SSA include poor access to care and high out-of-pocket costs .


Although SSA bears 24 % of the global disease burden , it has only 3 % of the global health workforce .


Given such limited resources , cost-effective strategies , such as task shifting , are needed to mitigate the rising CVD epidemic in SSA .


Ghana , a country in SSA with an established community health worker program integrated within a national health insurance scheme provides an ideal platform to evaluate implementation of the World Health Organization ( WHO ) task-shifting strategy .


This study will evaluate the comparative effectiveness of the implementation of the WHO Package targeted at CV risk assessment versus provision of health insurance coverage , on blood pressure ( BP ) reduction .


Using a cluster randomized design , 32 community health centers ( CHCs ) and district hospitals in Ghana will be randomized to either the intervention group ( 16 CHCs ) or the control group ( 16 CHCs ) .


A total of 640 patients with uncomplicated hypertension ( BP 140-179/90 -99 mm Hg and absence of target organ damage ) will be enrolled in this study ( 20 patients per CHC ) .


The intervention consists of WHO Package of CV risk assessment , patient education , initiation and titration of antihypertensive medications , behavioral counseling on lifestyle behaviors , and medication adherence every three months for 12 months .


The primary outcome is the mean change in systolic BP from baseline to 12 months .


The secondary outcomes are rates of BP control at 12 months ; levels of physical activity , percent change in weight , and dietary intake of fruits and vegetables at 12 months ; and sustainability of intervention effects at 24 months .


All outcomes will be assessed at baseline , six months and 12 months .


Trained community health nurses will deliver the intervention as part of Ghana 's community-based health planning and services ( CHPS ) program .


Findings from this study will provide policy makers and other stakeholders needed information to recommend scalable and cost-effective policy with respect to comprehensive CV risk reduction and hypertension control in resource-poor settings .


NCT01802372 .


Because insulin dosing requires optimization of glycemic control , it is important to use a single metric of benefit and risk to determine best insulin dosing practices .


We retrospectively applied a multiplicative clinical utility index ( CUI ) to a study of LY2605541 ( Eli Lilly and Company , Indianapolis , IN ) , a novel , long-acting basal insulin .


A CUI was developed to transform the multidimensional problem of assessing benefit/risk of multiple dosing algorithms into a single decision-making metric to evaluate two LY2605541 dosing algorithms relative to the insulin glargine ( GL ) dosing algorithm .


The CUI was applied to data in a 12-week , open-label , Phase 2 trial in patients with type 2 diabetes mellitus who were randomized to one of two dosing algorithms for LY2605541 ( LY1 or LY2 ) or GL ( algorithm similar to LY1 ) .


The CUI was created ( via expert input ) by weighing the relative benefit/risk of four components ( glycosylated hemoglobin [ HbA1c ] , percentage of patients with HbA1c 7 % , hypoglycemia rate , and time to steady-state dose ) ; individual utility values were multiplied to compute CUI values for LY1 and LY2 relative to GL , and bootstrap samples were used to determine variability .


The mean CUI was 0.82 for LY1 and 1.35 for LY2 .


Based on 3,000 bootstrap samples , there was a 48 % probability of LY2 performing better than LY1 and a 28 % probability of LY1 performing better than LY2 .


CUI methodology , and in particular this CUI , is a useful tool for comparing dosing algorithms .


Based on this CUI , LY2 is likely to be a better dosing algorithm than LY1 .


Patients undergoing open heart surgery with cardiopulmonary bypass ( CPB ) often develop a systemic immune reaction , characterized by an increase of proinflammatory and anti-inflammatory mediators .


We previously demonstrated that continued mechanical ventilation during CPB reduces this response .


We hypothesized that this strategy may also impact on matrix metalloproteinase ( MMP ) release .


Thirty consecutive patients undergoing coronary artery bypass grafting with CPB were randomized into a ventilated ( VG ) ( n = 15 ) and a standard non-ventilated group ( NVG ) ( n = 15 ) .


Blood was collected at the beginning , at the end of surgery , and on the five consecutive days .


MMPs , tissue inhibitor of matrix metalloproteinase 1 ( TIMP-1 ) , and lipocalin 2 ( LCN2 ) were measured by enzyme-linked immunosorbent assay .


Parameters of transpulmonary oxygen transport were assessed at different time points .


MMP-8 , MMP-9 , and LCN2 were significantly lower at the end of surgery in VG compared with those in NVG patients ( MMP-8 [ ng/mL ] : 7.1 [ 3.5 ] versus 12.5 [ 7.7 ] , P = 0.02 ; MMP-9 [ ng/mL ] : 108 [ 42 ] versus 171 [ 98 ] , P = 0.029 ; LCN2 [ ng/mL ] : 109 [ 42 ] versus 171 [ 98 ] , P = 0.03 ) .


TIMP-1 concentrations were lower on postoperative day one , ( TIMP-1 [ ng/mL ] : 174 [ 55 ] versus 273 [ 104 ] , P = 0.003 ) , whereas MMP-3 levels were lower on postoperative days four and five ( MMP-3 [ ng/mL ] : 44 [ 17 ] versus 67 [ 35 ] , P = 0.026 ) .


The arterial partial pressure of oxygen/fraction of inspired oxygen ratio was significantly higher in VG patients throughout the postoperative observation period , which did not affect the length of postoperative ventilatory support .


Continued mechanical ventilation during CPB reduces serum levels of MMPs , their inhibitor TIMP-1 and LCN2 , which preserves MMP-9 activity .


The present study suggests that continued mechanical ventilation improves postoperative oxygenation and could potentially prevent aggravation of lung injury after CPB .


Opicapone is a novel third generation catechol-O-methyltransferase ( COMT ) inhibitor .


The purpose of this study was to compare the levodopa pharmacokinetic profile throughout a day driven by the COMT inhibition either following repeated doses of opicapone or concomitant administration with entacapone .


A randomized , double-blind , gender-balanced , parallel-group study was performed in 4 groups of 20 healthy subjects each .


Four subjects in each group received placebo during the entire study .


Sixteen subjects in one group received placebo once daily for 11 days and on day 12 , 200 mg entacapone concomitantly with each levodopa/carbidopa dose ( three times separated by a 5-h interval ) .


Sixteen subjects in each of the remaining three groups received respectively 25 , 50 , and 75 mg opicapone once daily for 11 days and on day 12 , placebo concomitantly with each levodopa/carbidopa dose .


Levodopa minimum plasma concentration ( Cmin ) for each levodopa/carbidopa dose and for the mean of all levodopa/carbidopa doses increased substantially with all active treatments ( entacapone and opicapone ) when compared to the control group ( placebo ) , with values ranging from 1.7-fold ( 200 mg entacapone ) to 3.3-fold ( 75 mg opicapone ) .


No statistical difference was found for levodopa peak of systemic exposure ( as assessed by maximum observed plasma concentration ( Cmax ) ) between all active treatments and placebo .


A significant increase in the levodopa extent of systemic exposure ( as assessed by concentration-time curve ( AUC ) ) occurred with all opicapone treatments in relation to placebo .


No statistical difference was found for levodopa AUC when entacapone was compared to placebo .


When compared to entacapone , both 50 and 75 mg opicapone presented a significant increase for the levodopa AUC .


All active treatments significantly inhibited both peak ( as assessed by Emax ) and extent ( as assessed by effect-time curve ( AUEC ) ) of the COMT activity in relation to placebo .


When compared to entacapone , all opicapone treatments significantly decreased the extent ( AUEC ) of the COMT activity due to a long-lasting and sustained effect .


The tolerability profile was favorable for all active treatments .


Opicapone , a novel third generation COMT inhibitor , when compared to entacapone , provides a superior response upon the bioavailability of levodopa associated to more pronounced , long-lasting , and sustained COMT inhibition .


The tolerability profile was favorable .


On the basis of the results presented in this study and along with the earlier pharmacology studies , it is anticipated that opicapone adjunct therapy at the dosages of 25 and 50 mg will provide an enhancement in levodopa availability that will translate into clinical benefit for Parkinson 's disease patients .


To analyze the acute physiological response to aerobic short-interval training ( AESIT ) at various high-intensity running speeds .


A minor anaerobic glycolytic energy supply was aimed to mimic the characteristics of slow continuous runs .


Eight trained male runners ( maximal oxygen uptake [ VO ( 2max ) ] 55.5 3.3 mL kg ( -1 ) min ( -1 ) ) performed an incremental treadmill exercise test ( increments : 0.75 km h ( -1 ) min ( -1 ) ) .


Two lactate turn points ( LTP1 , LTP2 ) were determined .


Subsequently , 3 randomly assigned AESIT sessions with high-intensity running-speed intervals were performed at speeds close to the speed ( v ) at VO ( 2max ) ( vVO ( 2max ) ) to create mean intensities of 50 % , 55 % , and 60 % of vLTP1 .


AESIT sessions lasted 30 min and consisted of 10-s work phases , alternated by 20-s passive recovery phases .


To produce mean velocities of 50 % , 55 % , and 60 % of vLTP1 , running speeds were calculated as 18.6 0.7 km/h ( 93.4 % vVO ( 2max ) ) , 20.2 0.6 km/h ( 101.9 % vVO ( 2max ) ) , and 22.3 0.7 km/h ( 111.0 % vVO ( 2max ) ) , which gave a mean blood lactate concentration ( La ) of 1.09 0.31 mmol/L , 1.57 0.52 mmol/L , and 2.09 0.99 mmol/L , respectively .


La at 50 % of vLTP1 was not significantly different from La at vLTP1 ( P = .8894 ) .


Mean VO ( 2 ) was found at 54.0 % , 58.5 % , and 64.0 % of VO ( 2max ) , while at the end of the sessions VO ( 2 ) rose to 71.1 % , 80.4 % , and 85.6 % of VO ( 2max ) , respectively .


The results showed that AESIT with 10-s work phases alternating with 20 s of passive rest and a running speed close to vVO ( 2max ) gave a systemic aerobic metabolic profile similar to slow continuous runs .


Cluster analysis can be used to identify individuals similar in profile based on response to multiple pain sensitivity measures .


There are limited investigations into how empirically derived pain sensitivity subgroups influence clinical outcomes for individuals with spine pain .


The purposes of this study were : ( 1 ) to investigate empirically derived subgroups based on pressure and thermal pain sensitivity in individuals with spine pain and ( 2 ) to examine subgroup influence on 2-week clinical pain intensity and disability outcomes .


A secondary analysis of data from 2 randomized trials was conducted .


Baseline and 2-week outcome data from 157 participants with low back pain ( n = 110 ) and neck pain ( n = 47 ) were examined .


Participants completed demographic , psychological , and clinical information and were assessed using pain sensitivity protocols , including pressure ( suprathreshold pressure pain ) and thermal pain sensitivity ( thermal heat threshold and tolerance , suprathreshold heat pain , temporal summation ) .


A hierarchical agglomerative cluster analysis was used to create subgroups based on pain sensitivity responses .


Differences in data for baseline variables , clinical pain intensity , and disability were examined .


Three pain sensitivity cluster groups were derived : low pain sensitivity , high thermal static sensitivity , and high pressure and thermal dynamic sensitivity .


There were differences in the proportion of individuals meeting a 30 % change in pain intensity , where fewer individuals within the high pressure and thermal dynamic sensitivity group ( adjusted odds ratio = 0.3 ; 95 % confidence interval = 0.1 , 0.8 ) achieved successful outcomes .


Only 2-week outcomes are reported .


Distinct pain sensitivity cluster groups for individuals with spine pain were identified , with the high pressure and thermal dynamic sensitivity group showing worse clinical outcome for pain intensity .


Future studies should aim to confirm these findings .


To evaluate attainment of diabetes-related quality measures with canagliflozin , a sodium glucose cotransporter 2 inhibitor , versus sitagliptin in patients with type 2 diabetes mellitus ( T2DM ) .


This post hoc analysis included data from a 52-week , randomized , double-blind , phase 3 study comparing canagliflozin 300 mg and sitagliptin 100 mg in patients with T2DM on metformin plus sulfonylurea .


Individual and composite diabetes-related quality measures based on glycated hemoglobin ( A1C ) , blood pressure ( BP ) , low-density lipoprotein cholesterol ( LDL-C ) level , body mass index ( BMI ) , and body weight were assessed in the overall population and a subgroup with a baseline BMI of at least 25 kg/m .


At baseline , the proportion of patients meeting criteria for quality measures was similar between groups .


At week 52 , more canagliflozin-treated patients achieved quality measures of an A1C less than 8 % or less than 7 % , and fewer canagliflozintreated patients had an A1C greater than 9 % , compared with sitagliptin .


More patients achieved BP measurement less than 140/90 mm Hg , less than 140/80 mm Hg , or less than 130/80 mm Hg with canagliflozin versus sitagliptin .


The proportion of patients with an LDL-C level less than 100 mg/dL was similar between groups .


More patients had a BMI of at least 25 kg/m and a greater than 10 lb ( 4.5 kg ) weight loss from baseline , and a BMI less than 30 kg/m at week 52 , with canagliflozin versus sitagliptin .


A greater proportion of patients achieved composite end points based on A1C , BP , and LDL-C level with canagliflozin versus sitagliptin .


Similar results were observed in the subgroup of patients with a baseline BMI of at least 25 kg/m .


In this study involving patients with T2DM on metformin plus sulfonylurea , after 52 weeks , patients treated with canagliflozin 300 mg demonstrated better attainment of individual and composite diabetes-related quality measures compared with patients treated with sitagliptin 100 mg .


The purpose of this study was to determine the safety and efficacy of adjuvant albendazole medication in percutaneous liver hydatid cyst treatment with puncture , aspiration , injection , and reaspiration ( PAIR ) method .


Between November 2007 and May 2011 , total of 39 patients with newly diagnosed liver hydatid cyst ( total of 77 cysts ) were prospectively randomized and enrolled in 3 groups .


In the first group , cysts ( n = 14 ) were treated with PAIR without albendazole .


In the second ( n = 16 ) and third groups ( n = 47 ) , cysts were treated with PAIR with albendazole 1 week before and 1 month after the procedure , with albendazole 1 week before and 3 months after the procedure respectively .


Technical and clinical success rates were 100 and 96.1 % respectively .


In 3 of 77 cysts ( 3.9 % ) , findings of recurrence were detected on US imaging .


All recurrent cysts were in group 1 and recurrence rates in this group were statistically different from cysts of second and third groups ( p = 0.005 ) .


Side effects of albendazole were detected in 7 of 29 patients ( 24.1 % ) , and no statistically significant difference was observed between the second ( 15.3 % ) and third ( 38.4 % ) groups ( p = 0.378 ) .


Use of albendazole medication as an adjuvant to percutaneous treatment of liver hydatid cyst decreases the recurrence rate .


Although there is no statistically significant difference between groups 2 and 3 in terms of efficacy and recurrence rate , patients in group 3 had a higher rate of side effect .


Therefore , we conclude that albendazole treatment 1 week before and 1 month after PAIR treatment is sufficient to reduce/prevent recurrences .


Liver cirrhosis is one of the major consequences of hepatitis B virus ( HBV ) infection , and transplantation of autologous bone marrow mesenchymal stem cells ( ABMSCs ) is one of promising therapies for patients with HBV-related liver cirrhosis ( HBV-LC ) .


However , the mechanism is unclear .


The aim of the current study was to explore the role of Treg/Th17 cells in ABMSCs transplantation in patients with HBV-LC .


In this prospective study , 56 patients were enrolled and randomly assigned to transplantation group and control group .


After 24-week follow-up , 39 patients completed the study ( 20 cases in transplantation group and 19 cases in control group ) .


The Model for End-Stage Liver Disease scores , liver function , changes of Treg/Th17 cells , as well as related transcription factors and serum cytokines , were determined .


Although patients in both groups showed significant improvement after Entecavir treatment , ABMSC transplantation further improved patients ' liver function .


Moreover , there was a significant increase in Treg cells and a marked decrease in Th17 cells in the transplantation group compared with control , leading to an increased Treg/Th17 ratio .


Furthermore , mRNA levels of Treg-related transcription factor ( Foxp3 ) and Th17-related transcription factor ( RORt ) were increased and decreased , respectively .


In addition , serum transforming growth factor - levels were significantly higher at early weeks of transplantation , while serum levels of interleukin-17 , tumor necrosis factor - , and interleukin-6 were significantly lower in patients in the transplantation group compared with control .


ABMSCs transplantation was effective in improving liver function in patients with HBV-LC , which was mediated , at least in part , through the regulation of Treg/Th17 cell balance .


To study the effect of melatonin ( melaxen ) on sleep disorders in patients with mild cranial-brain injury ( CBI ) in the early rehabilitation period .


Sixty patients were randomized to equal groups treated or not treated with melaxen .


Along with neurological and somatic examination , polysomnography and scales for measurement depression and quality of life ( ESS , BDI , EuroQol etc ) were used .


Melatonin improved sleep ( sleep latency , number of wakings per night etc ) and decreased the severity of depression in the early rehabilitation period after mild CBI .


Further research is needed to fully understand the effect of melatonin on sleep disorders in CBI , in particular in its later stages .


To evaluate factors associated with low consumption of fruits and vegetables among preschoolers from families treated at basic health centers in Porto Alegre , RS , Brazil .


This was a cohort study nested in a randomized field trial .


Data collection was performed through structured questionnaires to obtain demographic and dietary data , combined with two 24-hour recalls in the age groups 12-16 months and again at 2-3 years of age .


Data on the consumption of one daily serving of fruits ( 80 g ) and vegetables ( 60 g ) were evaluated , as well as consumption of non-recommended foods such as candy , chocolate , and soft drinks .


Statistical analyses were performed using Poisson regression with robust estimation .


A total of 388 children aged 2-3 years were evaluated ; of these , 58 % and 87.4 % did not consume one daily serving of fruits and vegetables , respectively .


The following factors were negatively associated with fruit consumption : family income higher than four minimum wages , ( p = 0.024 ) , lower paternal educational level ( p = 0.03 ) , and lower fruit consumption at 12-16 months ( p = 0.002 ) .


Factors negatively associated with the consumption of vegetables were low paternal educational level ( p = 0.033 ) and consumption of high-sugar content beverages at 12-16 months ( p = 0.014 ) .


This study demonstrated a high prevalence of children who consumed less than one daily serving of fruit and vegetables ; early feeding practices , parental education , and family income were associated with this process .


Pilonidal sinus is a common infectious process which occurs in buttocks and sacral area which involves a wide range of symptoms that are different from an asymptomatic sinus abscess to acute and chronic sinus track .


Basically non-surgical treatment for this disease is not recommended .


In this study , we have been compared two methods of primary repair and rotation flap in terms of factors such as duration of hospitalization , recurrence , infection etc. .


80 patients with chronic pilonidal sinus were randomly divided into two groups and underwent surgery .


Diabetic and obese patients with underlying diseases and patients with acute pilonidal abscess or prior surgery were excluded .


The patients ' hospital stay , duration of postoperative pain , itching and hematoma , were investigated .


In this study , patients ' sex and mean age were examined in terms of frequency of complications of hematoma , wound infection , recurrence , itching , and duration of hospitalization and the presence of seroma , there is no significant difference between the two methods of primary surgical repair and rotation flap ( P > 0.05 ) But in terms of the opening of the surgical wound , in primary surgical method , 5 patients ( 12.5 % ) , wound dehiscence were reported , in rotation flap , any case of wound dehiscence were reported .


There is significant difference between wound dehiscence in patients with chronic pilonidal sinus and two methods of surgery .


( P = 0.02 ) .


The mean duration of pain relief was 15.2 3.35 days in the primary surgical repair method and rotation flap was 7 2.3 days .


According to the test there is significant difference between mean duration of pain relief and two surgical methods .


( P = 0.001 ) .


The mean duration of sutures was 15.3 2.3 days in the primary repair method and in rotational flap was 12 3.6 days .


There is significant difference between the mean duration of sutures and two surgical methods ( P = 0.001 ) CONCLUSION : Considering these results , rotational flap is the preferred method due to fewer complications , lower recurrence after surgery and faster healing time of surgical wounds and as a result , the effective force 's early return to economic cycle .


Finally , we can say that each surgeon according to the type and size of the sinuses and occupational status and social class , personality and individuality of the patient can select the appropriate method of surgery .


This study aims to prospectively assess the incidence of hypercalciuria and hypercalcemia with different doses of vitamin D and with a calcium intake of approximately 1,200 mg/day .


This was a 1-year randomized placebo-controlled study of vitamin D ( 400-4 ,800 IU/d ) in 163 white women aged 57 to 90 years .


Calcium citrate tablets ( 200 mg ) were added to the diet to achieve a total calcium intake of approximately 1,200 mg/day in all groups .


All women had vitamin D insufficiency at baseline , with serum 25-hydroxyvitaminD levels lower than 20 ng/mL ( 50 nmol/L ) .


Serum and 24-hour urine calcium were collected every 3 months on supplementation , any test result above the upper reference range represented an episode of hypercalcemia or hypercalciuria .


Mixed-effects models and multivariate logistic regression were used in the analysis .


Hypercalcemia ( > 10.2 mg/dL [ 2.55 mmol/L ] ) occurred in 8.8 % of white women .


Hypercalciuria ( > 300 mg/d [ 7.5 mmol ] ) occurred in 30.6 % of white women .


Episodes of hypercalciuria were transient in half of the group and recurrent in the other half .


No relationship between hypercalcemia or hypercalciuria and vitamin D dose was found , and hypercalciuria was equally common in the placebo group .


Hypercalciuria and hypercalcemia commonly occur with vitamin D and calcium supplements .


Whether hypercalciuria and hypercalcemia are caused by calcium , vitamin D , or both is unclear .