Moreover , it will provide valuable information about the occurrence of eating disorder risk factors in school-aged children .


ISRCTN97989348 ; Registered 19 December 2012 .


In chronic human immunodeficiency virus ( HIV ) infection , plasma cystatin C may be influenced by factors other than glomerular filtration rate such as inflammation .


Statins may improve cystatin C by improving glomerular function or by decreasing inflammation .


The Stopping Atherosclerosis and Treating Unhealthy Bone With Rosuvastatin in HIV ( SATURN-HIV ) trial randomized 147 patients on stable antiretroviral therapy ( ART ) with low-density lipoprotein cholesterol 130 mg/dL to blinded 10 mg daily rosuvastatin or placebo .


We analyzed relationships of baseline and 0 - to 24-week changes in plasma cystatin C concentration with measures of vascular disease , inflammation , and immune activation .


Median age was 46 ( interquartile range , 40-53 ) years ; 78 % were male , 68 % African American .


Tenofovir and protease inhibitors were used in 88 % and 49 % of subjects , respectively .


Baseline cystatin C was associated with higher carotid intima-media thickness and epicardial adipose tissue independent of age , sex , and race .


Biomarkers of endothelial activation and inflammation were associated with cystatin C in a multivariable model independent of creatinine-based estimated glomerular filtration rate ( eGFRcr ) .


After 24 weeks , statin use slowed mean eGFRcr decline ( 1.61 vs -3.08 mL/minute/1 .73 m ( 2 ) for statin vs placebo ; P = .033 ) and decreased mean cystatin C ( -0.034 mg/L vs 0.010 mg/L ; P = .008 ) .


Within the statin group , changes in cystatin C correlated with changes in endothelial activation , inflammation , and T-cell activation .


Rosuvastatin 10 mg daily reduces plasma cystatin C and slows kidney function decline in HIV-infected patients on ART .


Reductions in cystatin C with statin therapy correlate with reductions in inflammatory biomarkers .


Relationships between cystatin C , kidney function , and cardiovascular risk in HIV may be mediated in part by inflammation .


Clinical Trials Registration .


NCT01218802 .


The steady-state pharmacokinetics of two doses of a transdermal testosterone cream ( TTC ) was investigated after daily application for 21 days .


This was a two-way cross-over study conducted for 6 weeks .


Seven healthy postmenopausal women ( mean age , 59.3 y ) were randomly allocated to 5 or 10 mg of TTC applied daily to the upper arm .


Serum total testosterone ( TT ) , free testosterone ( fT ) , sex hormone-binding globulin , and metabolite concentrations were measured .


Baseline-corrected and uncorrected serum TT and fT pharmacokinetic parameters ( AUC0-24 , C avg , Cmax , and Tmax ) were calculated using a standard model-independent approach .


After the single-dose application of 5 mg of TTC on day 22 , the median uncorrected TT C avg was found to be 0.54 ng/mL ( range , 0.43-1 .31 ) , and the median uncorrected fT C avg was found to be 4.14 pg/mL ( range , 2.41-9 .72 ) .


Doubling of the dose only resulted in a 30 % increase in baseline-corrected TT C avg ( 0.52 vs 0.69 ng/mL for 5 and 10 mg , respectively ) and a 31 % increase in baseline-corrected fT C avg ( 4.75 vs 6.24 pg/mL for 5 and 10 mg , respectively ) .


Neither dose resulted in any meaningful variation in dihydrotestosterone , estrone , estradiol , or sex hormone-binding globulin across the postdose sampling period .


The 5-mg TTC dose restores TT and fT levels to levels above and within the reference range , respectively , for premenopausal women .


Transbronchial lung biopsy ( TBLB ) is required for evaluation in selected patients with interstitial lung disease ( ILD ) .


The diagnostic yield of histopathologic assessment is variable and is influenced by factors such as the size of samples and the presence of crush artefacts left by conventional biopsy forceps .


We compared the diagnostic yield and safety of TBLB with cryoprobe sampling versus conventional forceps sampling .


This randomized clinical trial analysed data for 77 patients undergoing TBLB for evaluation of ILD ; patients were assigned to either a conventional-forceps group or a cryoprobe group .


Two pathologists assessed the tissue samples and agreed on histopathologic diagnoses .


We also compared the duration of procedures , complications and sample-quality variables .


The most frequent diagnosis observed in the cryoprobe group was non-specific interstitial pneumonia .


Histopathologic diagnoses were identified in more cases in the cryoprobe group ( 74.4 % ) than in the conventional-forceps group ( 34.1 % ) ( P < 0.001 ) , and the diagnostic yield was higher in the cryoprobe group ( 51.3 % vs 29.1 % in the conventional forceps group ; P = 0.038 ) .


A larger mean area of tissue was harvested by cryoprobe ( 14.7 11 mm ( 2 ) ) than by conventional forceps ( 3.3 4.1 mm ( 2 ) ) ( P < 0.001 ) .


More grade 2 bleeding ( not statistically significant ) occurred in the cryoprobe group ( 56.4 % ) than in the conventional-forceps group ( 34.2 % ) .


No differences in other complications were observed .


TBLB by cryoprobe is safe and potentially useful in the diagnosis of ILD .


Larger multisite randomized trials are required to confirm the potential benefits of this procedure .


Clinical trial registration at ClinicalTrials.gov : NCT01064609 .


Armed conflicts are associated with a wide range of impacts on the mental health of children and adolescents .


We evaluated the effectiveness of a school-based intervention aimed at reducing symptoms of posttraumatic stress disorder , depression , and anxiety ( treatment aim ) ; and improving a sense of hope and functioning ( preventive aim ) .


We conducted a cluster randomized trial with 329 children in war-affected Burundi ( aged 8 to 17 ( mean 12.29 years , standard deviation 1.61 ) ; 48 % girls ) .


One group of children ( n = 153 ) participated in a 15-session school-based intervention implemented by para-professionals , and the remaining 176 children formed a waitlist control condition .


Outcomes were measured before , one week after , and three months after the intervention .


No main effects of the intervention were identified .


However , longitudinal growth curve analyses showed six favorable and two unfavorable differences in trajectories between study conditions in interaction with several moderators .


Children in the intervention condition living in larger households showed decreases on depressive symptoms and function impairment , and those living with both parents showed decreases on posttraumatic stress disorder and depressive symptoms .


The groups of children in the waitlist condition showed increases in depressive symptoms .


In addition , younger children and those with low levels of exposure to traumatic events in the intervention condition showed improvements on hope .


Children in the waitlist condition who lived on their original or newly bought land showed improvements in hope and function impairment , whereas children in the intervention condition showed deterioration on these outcomes .


Given inconsistent effects across studies , findings do not support this school-based intervention as a treatment for posttraumatic stress disorder and depressive symptoms in conflict-affected children .


The intervention appears to have more consistent preventive benefits , but these effects are contingent upon individual ( for example , age , gender ) and contextual ( for example , family functioning , state of conflict , displacement ) variables .


Results suggest the potential benefit of school-based preventive interventions particularly in post-conflict settings .


The study was registered as ISRCTN42284825 .


Although fresh frozen plasma ( FFP ) is one of the most commonly used hemostatic agents in clinical specialties today , there is little evidence available supporting its administration .


Our present study observed the effects of a priming strategy without FFP during cardiopulmonary bypass ( CPB ) on postoperative coagulation and clinical recovery in pediatric patients , aiming to supply new evidence for evidence-based use of FFP .


Eighty pediatric patients with congenital heart disease undergoing cardiac surgery with CPB were randomized to receive either 10-20 ml/kg 4 % succinylated gelatin ( Gelofusine , GEL group , n = 40 ) or 1-2 units FFP ( FFP group , n = 40 ) in the pump prime .


Rapid-thromboelastography ( r-TEG ) and functional fibrinogen level were measured before skin incision and 15 minutes after heparin reversal .


We recorded the volume of chest tube drainage , transfusion requirements and the dosage of pharmacological agents .


The ventilation time , ICU length of stay and hospitalization time after surgery were also collected .


After heparin neutralization , there were significantly elevated levels of fibrinogen in the FFP group , which were manifested by r-TEG parameters MAf and FLEV .


No significant differences were observed between the two groups in postoperative bleeding , transfusion requirements and the usage of pharmacological agents .


Recovery time was also comparable between the two groups .


In conclusion , prophylactic use of FFP in the priming solution does not provide clinical benefits as presumed .


Artificial colloids , such as Gelofusine , can be used safely and effectively as a substitute for FFP in the pump prime .


TEG is an effective assessment tool to evaluate postoperative coagulation function in pediatric patients .


The prevalence of heart failure ( HF ) is rising in industrialized and developing countries .


Though invasive coronary angiography ( ICA ) remains the gold standard for anatomical assessment of coronary artery disease in HF patients , alternatives are being sought .


Computed tomographic coronary angiography ( CTA ) has emerged as an accurate non-invasive diagnostic tool for coronary artery disease ( CAD ) and has been demonstrated to have prognostic value .


Whether or not CTA can be used in HF patients is unknown .


Acknowledging the aging population , the growing prevalence of HF and the increasing financial burden of healthcare , we need to identify non-invasive diagnostic tests that are available , safe , accurate and cost-effective .


The proposed study aims to provide insight into the efficacy of CTA in HF patients .


A multicenter randomized controlled trial will enroll 250 HF patients requiring coronary anatomical definition .


Enrolled patients will be randomized to either CTA or ICA ( n = 125 per group ) as the first test to define coronary anatomy .


The primary outcomes will be collected to determine downstream resource utilization .


Secondary outcomes will include the composite clinical events and major adverse cardiac events .


In addition , the accuracy of CTA for detecting coronary anatomy and obstruction will be assessed in patients who subsequently undergo both CTA and ICA .


It is expected that CTA will be a more cost-effective strategy for diagnosis : yielding similar outcomes with fewer procedural risks and improved resource utilization .


ClinicalTrials.gov , NCT01283659 .


Team grant #CIF 99470 .


People with multiple and persistent mental and physical health problems have high rates of transition failures when transferring from a hospital level of care to home .


The transitional care model ( TCM ) is evidence-based and demonstrated to improve posthospital outcomes for elderly with physical health conditions , but it has not been studied in the population with serious mental illness .


Using a randomized controlled design , 40 inpatients from two general hospital psychiatric units were recruited and randomly assigned to an intervention group ( n = 20 ) that received the TCM intervention that was delivered by a psychiatric nurse practitioner for 90 days posthospitalization , or a control group ( n = 20 ) that received usual care .


Outcomes were as follows : service utilization , health-related quality of life , and continuity of care .


The intervention group showed higher medical and psychiatric rehospitalization than the control group ( p = .054 ) .


Emergency room use was lower for intervention group but not statistically significant .


Continuity of care with primary care appointments were significantly higher for the intervention group ( p = .023 ) .


The intervention group 's general health improved but was not statistically significant compared with controls .


A transitional care intervention is recommended ; however , the model needs to be modified from a single nurse to a multidisciplinary team with expertise from a psychiatric nurse practitioner , a social worker , and a peer support specialist .


A team approach can best manage the complex physical/mental health conditions and complicated social needs of the population with serious mental illness .


To compare the operative data and early postoperative outcomes of total laparoscopic hysterectomy ( TLH ) , laparoscopically assisted vaginal hysterectomy ( LAVH ) and vaginal hysterectomy ( VH ) .


One hundred and eight women requiring hysterectomy for enlarged myomatous uterus were randomly allocated into three treatment arms : TLH ( n = 36 ) ; LAVH ( n = 36 ) ; VH ( n = 36 ) .


Randomization procedure was based on a computer-generated list .


The primary outcome was the discharge time comparison .


The secondary outcomes were operating time , blood loss , paralytic ileus time , intraoperative complications , postoperative pain , and early postoperative complications .


The mean discharge time was shorter after VH than after LAVH and TLH ( P = 0.001 ) .


Operating time significantly influenced the discharge time , considered as a dependent variable in general linear model analysis ( P = 0.006 ) .


In contrast , blood loss did not influence the discharge time ( P = 0.55 ) .


The mean operating time was significantly shorter in VH than in TLH and LAVH groups ( P = 0.000 ) .


The intraoperative blood loss was greater during LAVH than during TLH and VH ( P = 0.000 ) .


Paralytic ileus time was shorter after VH than after TLH and LAVH ( P = 0.000 ) .


No intraoperative complications or conversion to laparotomy occurred .


VH was the faster operative technique with smaller blood loss and shorter discharge time compared with the others two techniques .


So , VH should be considered the preferred approach in patients with enlarged myomatous uteri .


When VH is not feasible or salpingo-oophorectomy is required , LAVH or TLH should be considered as valid alternatives .


It is necessary to continue prospective comparative studies between the various surgical options to identify the best approach for hysterectomy in each single woman .


Hirsutism has negative impact on adolescent psychosocial development for both cosmetic and endocrine reasons .


This study evaluated the effectiveness of a new intermittent , low-dose finasteride regimen consisting of 2.5 mg of drug given every 3 days ( 1 day of treatment , 2 days of drug withdrawal ) for 6 months in girls with hirsutism by polycystic ovarian syndrome ( PCOS ) or idiopathic hirsutism ( IH ) .


Twenty-eight girls ( 15-19 y old ) with hirsutism were randomly assigned to 2 treatment groups and treated for 6 months .


Fourteen patients ( 7 with IH , 7 with PCOS ) received finasteride ; fourteen patients ( 7 with IH , 7 with PCOS ) received placebo .


Hirsutism score ( HS ) , clinical , and hormonal effects were compared between the 2 groups .


In patients treated with finasteride , the HS value at 6 months was 52.9 % lower than that observed at baseline in girls with IH , and 52.8 % lower in girls with PCOS ( P < .0001 for both ) .


Similarly , the 3-17 - androstenediol glucuronide serum levels were decreased by 34.8 % in patients with IH , and by 47.5 % in patients with PCOS ( P < .0001 , respectively ) .


Finasteride treatment was well tolerated and did not alter values of BMI , serum levels of sexual hormones , metabolic parameters related to liver and kidney function as well as glycemic and lipidic asset .


A low-dose of finasteride , given every 3 days , reduces the HS in young patients affected by PCOS or IH .


Compared with conventional continuous finasteride administration , the intermittent low-dose regimen has similar efficacy with the advantage to be safer and less expensive .


Relevant clinical data are needed given the increasing national interest in charged particle radiation therapy ( CPT ) programs .


Here we report long-term outcomes from the only randomized , stratified trial comparing CPT with iodine-125 plaque therapy for choroidal and ciliary body melanoma .


From 1985 to 1991 , 184 patients met eligibility criteria and were randomized to receive particle ( 86 patients ) or plaque therapy ( 98 patients ) .


Patients were stratified by tumor diameter , thickness , distance to disc/fovea , anterior extension , and visual acuity .


Tumors close to the optic disc were included .


Local tumor control , as well as eye preservation , metastases due to melanoma , and survival were evaluated .


Median follow-up times for particle and plaque arm patients were 14.6 years and 12.3 years , respectively ( P = .22 ) , and for those alive at last follow-up , 18.5 and 16.5 years , respectively ( P = .81 ) .


Local control ( LC ) for particle versus plaque treatment was 100 % versus 84 % at 5 years , and 98 % versus 79 % at 12 years , respectively ( log rank : P = .0006 ) .


If patients with tumors close to the disc ( < 2 mm ) were excluded , CPT still resulted in significantly improved LC : 100 % versus 90 % at 5 years and 98 % versus 86 % at 12 years , respectively ( log rank : P = .048 ) .


Enucleation rate was lower after CPT : 11 % versus 22 % at 5 years and 17 % versus 37 % at 12 years , respectively ( log rank : P = .01 ) .


Using Cox regression model , likelihood ratio test , treatment was the most important predictor of LC ( P = .0002 ) and eye preservation ( P = .01 ) .


CPT was a significant predictor of prolonged disease-free survival ( log rank : P = .001 ) .


Particle therapy resulted in significantly improved local control , eye preservation , and disease-free survival as confirmed by long-term outcomes from the only randomized study available to date comparing radiation modalities in choroidal and ciliary body melanoma .


There is a need for controlled trials to guide the perioperative management of patients undergoing endoscopic sinus surgery ( ESS ) .


The authors performed a pilot multicenter trial to compare two types of saline delivery devices in this population .


Patients were randomized to high volume saline irrigation with a squeeze bottle and low volume saline spray after ESS in patients with chronic rhinosinusitis ( CRS ) .


Surgeons were blinded to treatment , and one-month postoperative scores for sinonasal outcomes [ Sinonasal Outcome Test-22 ( SNOT-22 ) ] scale , nasal and sinus symptom score ( NSS ) , and perioperative sinus endoscopy ( POSE ) scale were compared with preoperative scores .


Nine centers provided data for 86 patients .


All three outcomes measures improved significantly for both groups .


Saline spray : SNOT-22 48.8 versus .


23.7 , treatment effect 25.1 ( 95 % confidence interval [ CI ] , 17.9-32 .2 ) , POSE 21.1 versus .


8.4 , treatment effect 12.7 ( 95 % CI , 9.2-16 .1 ) , and NSS 8.2 versus 5.0 , treatment effect 3.1 ( 95 % CI , 1.4-4 .9 ) pre - and postoperatively , respectively ( all p < 0.0001 ) .


Squeeze bottle : SNOT-22 49.5 versus 23.6 , treatment effect 25.9 ( 95 % CI , 20.3-31 .6 ) , POSE 18.6 versus 9.2 , treatment effect 9.3 , ( 95 % CI 6.7-12 .0 ) , and NSS 9.0 versus 5.7 , treatment effect 3.3 ( 95 % CI , 2.3-4 .3 ) pre - and postoperatively , respectively ( all p < 0.0001 ) .


Analysis of variance did not identify a difference between the two treatment groups .


Subgroup analysis based on preoperative disease severity did not change the nonassociation of saline bottle with outcome measures .


Post hoc sample size calculation determined that 176 patients is required to detect an 8.9-point difference in SNOT-22 scores .


In this pilot multicenter trial examining patients with chronic rhinosinusitis undergoing ESS , both squeeze bottle and saline spray showed significant improvement in SNOT-22 , POSE , and NSS scores at one-month postoperatively .


Because the study was nonpowered , we can not rule out a potential difference between the two treatment groups .


Intentional weight loss in obese older adults is a risk factor for muscle loss and sarcopenia .


The objective was to examine the effect of a high whey protein - , leucine - , and vitamin D-enriched supplement on muscle mass preservation during intentional weight loss in obese older adults .


We included 80 obese older adults in a double-blind randomized controlled trial .


During a 13-wk weight loss program , all subjects followed a hypocaloric diet ( -600 kcal/d ) and performed resistance training 3/wk .


Subjects were randomly allocated to a high whey protein - , leucine - , and vitamin D-enriched supplement including a mix of other macro - and micronutrients ( 150 kcal , 21 g protein ; 10/wk , intervention group ) or an isocaloric control .


The primary outcome was change in appendicular muscle mass .


The secondary outcomes were body composition , handgrip strength , and physical performance .


Data were analyzed by using ANCOVA and mixed linear models with sex and baseline value as covariates .


At baseline , mean SD age was 63 5.6 y , and body mass index ( in kg/m ( 2 ) ) was 33 4.4 .


During the trial , protein intake was 1.11 0.28 g kg body weight ( -1 ) d ( -1 ) in the intervention group compared with 0.85 0.24 g kg body weight ( -1 ) d ( -1 ) in the control group ( P < 0.001 ) .


Both intervention and control groups decreased in body weight ( -3.4 3.6 kg and -2.8 2.8 kg ; both P < 0.001 ) and fat mass ( -3.2 3.1 kg and -2.5 2.4 kg ; both P < 0.001 ) , with no differences between groups .


The 13-wk change in appendicular muscle mass , however , was different in the intervention and control groups [ +0.4 1.2 kg and -0.5 2.1 kg , respectively ; = 0.95 kg ( 95 % CI : 0.09 , 1.81 ) ; P = 0.03 ] .


Muscle strength and function improved over time without significant differences between groups .


A high whey protein - , leucine - , and vitamin D-enriched supplement compared with isocaloric control preserves appendicular muscle mass in obese older adults during a hypocaloric diet and resistance exercise program and might therefore reduce the risk of sarcopenia .


This trial was registered at the Dutch Trial Register ( http://www.trialregister.nl ) as NTR2751 .


Treatments for drug addiction and smoking in severely mentally ill ( SMI ) adults are needed .


To investigate the effect of a contingency management ( CM ) intervention targeting psycho-stimulant on cigarette smoking .


126 stimulant dependent SMI smokers were assigned to CM or a non-contingent control condition .


Rates of smoking-negative ( < 3 ppm ) carbon monoxide breath-samples were compared .


Individuals who received CM targeting psycho-stimulants were 79 % more likely to submit a smoking-negative breath-sample relative to controls .


This study provides initial evidence that a behavioral treatment for drug use results in reductions in cigarette smoking in SMI adults .


Although dipeptidyl-peptidase-4 inhibitors exert their major action via an incretin mechanism , a favorable effect of vildagliptin on lipid metabolism remains unexplained .


The objective was to examine hepatic triglyceride levels and insulin sensitivity on vildagliptin .


This was a 6-month , randomized , double-blind , placebo-controlled trial .


This was an outpatient study at a university clinical research center .


Individuals with type 2 diabetes ( n = 44 ) and glycated hemoglobin 7.6 % on stable metformin therapy were included .


Intervention was vildagliptin 50 mg twice a day or placebo over 6 months .


Main outcome measures were hepatic triglyceride levels and insulin sensitivity .


Mean fasting liver triglyceride content decreased by 27 % with vildagliptin , from 7.3 1.0 % ( baseline ) to 5.3 0.9 % ( endpoint ) .


There was no change in the placebo group .


The between-group difference in change from baseline was significant ( P = .013 ) .


Mean fasting plasma glucose concentration decreased over the study period with vildagliptin vs placebo by -1.0 mmol/L ( P = .018 ) , and there was a positive correlation between these decrements and liver triglyceride in the vildagliptin group at 3 months ( r = 0.47 ; P = .02 ) and 6 months ( r = 0.44 ; P = .03 ) .


Plasma alanine aminotransferase fell from 27.2 2.8 to 20.3 1.4 IU/L in the vildagliptin group ( P = .0007 ) , and there was a correlation between the decrements in alanine aminotransferase and liver triglyceride ( r = 0.83 ; P < .0001 ) .


Insulin sensitivity during the euglycemic clamp was similar in each group at baseline ( 3.24 0.30 vs 3.19 0.38 mg/kg/min ) and did not change ( adjusted mean change of 0.26 0.22 vs 0.32 0.22 mg/kg/min ; P = .86 ) .


Mean body weight decreased by 1.6 0.5 vs 0.4 0.5 kg in the vildagliptin and placebo groups , respectively ( P = .08 ) .


This study demonstrates that the dipeptidyl-peptidase-4 inhibitor vildagliptin brings about a clinically significant decrease in hepatic triglyceride levels during 6 months of therapy unrelated to change in body weight .


There was no change in peripheral insulin sensitivity .


To investigate the genomic response induced by ischaemic preconditioning ( IPC ) in muscle biopsies taken from the operative leg of total knee arthroplasty patients .


The gene expression profile GSE21164 was extracted from Gene Expression Omnibus ( GEO ) database .


Patients undergoing primary knee arthroplasty were randomized to control and treatment ( IPC ) groups .


Muscle biopsies were taken from the quadriceps muscle of the operative knee at the immediate onset of surgery ( T0 ) and at 1 hour into surgery ( T1 ) .


Limma package of R language was used to identify the differentially expressed genes ( DEGs ) between control and treatment group .


To find out specific genes , DEGs at T0 were compared with DEGs at T1 .


Scansite was used to find out the binding domain for specific DEGs .


Functional enrichment analysis was done by DAVID .


Of the genes queried on the Affymetrix Human Genome U133 Plus 2.0 microarray , we identified 263 ( T0 ) and 266 ( T1 ) DEGs compared to the control group .


Down-regulation of DEGs related with regulation neuron apoptosis was observed at T1 .


The most significant function of DEGs at T0 was related with neurological system process .


The most specific DEG was FAM125B at T0 and T1 time points .


Its common binding domain was SH3 .


The protective effect of IPC was associated with altered expression of genes involved in neurological system process and regulation of neuron apoptosis .


The dynamic expression of FAM125B can be a supervised marker during the surgery .


IPC may be of potential benefit in this and other musculoskeletal conditions .


Stigma associated with HIV has been documented as a barrier for accessing quality health-related services .


When the stigma manifests in the health care setting , people living with HIV receive substandard services or even be denied care altogether .


Although the consequences of HIV stigma have been documented extensively , efforts to reduce these negative attitudes have been scarce .


Interventions to reduce HIV stigma should be implemented as part of the formal training of future health care professionals .


The interventions that have been tested with health care professionals and published have several limitations that must be surpassed ( i.e. lack of comparison groups in research designs and longitudinal follow-up data ) .


Furthermore , Latino health care professionals have been absent from these intervention efforts even though the epidemic has affected this population disproportionately .


In this article , we describe an intervention developed to reduce HIV stigma among medical students in Puerto Rico .


A total of 507 medical students were randomly introduced into our intervention and control conditions .


The results show statistically significant differences between the intervention and control groups ; intervention group participants had lower HIV stigma levels than control participants after the intervention .


In addition , differences in HIV stigma levels between the groups were sustained for a 12-month period .


The results of our study demonstrate the efficacy of the modes of intervention developed by us and serve as a new training tool for future health care professionals with regard to stigma reduction .


Treatment with pegylated interferon ( peg-IFN ) alfa-2a ( 40KD ) results in hepatitis B `` e '' antigen ( HBeAg ) seroconversion 6 months after treatment in up to 36 % of HBeAg-positive chronic hepatitis B patients .


This study explored the efficacy of a novel combination of peg-IFN alfa-2a and entecavir ( ETV ) , a potent nucleoside analogue .


In total , 218 treatment-naive Chinese HBeAg-positive patients were randomized to peg-IFN alfa-2a ( 180 g/week ) for 48 weeks , either as monotherapy ( n = 72 ) , or with 24 weeks of ETV ( 0.5 mg/daily ) added at week 13 ( ETV add-on , n = 73 ) , or pretreatment with a 24-week course of ETV , starting peg-IFN alfa-2a at week 21 ( ETV pretreatment , n = 73 ) .


The primary endpoint was reduction in quantitative HBeAg from baseline to 24 weeks posttreatment .


Significant reductions in HBeAg from baseline were achieved in all treatment groups 24 weeks posttreatment ; reductions were comparable across treatment arms ( shown as log10 Paul Ehrlich international units [ PEIU ] / mL ) : monotherapy : -1.4 ( SD , 1.8 ) ; ETV add-on : -1.6 ( SD , 1.8 ) ; ETV pretreatment : -1.3 ( SD , 1.7 ) .


Rates of HBeAg seroconversion were similar across treatment groups posttreatment ( monotherapy : 22 [ 31 % ] ; ETV add-on : 18 [ 25 % ] ; ETV pretreatment : 19 [ 26 % ] ) .


Significantly greater reductions of hepatitis B virus DNA were achieved with ETV add-on while on treatment , but were not sustained posttreatment .


Safety profiles were comparable between treatment groups ; adverse events were experienced by 62 ( 86 % ) monotherapy , 65 ( 89 % ) ETV add-on , and 58 ( 81 % ) ETV pretreatment patients .


Neither ETV add-on nor ETV pretreatment demonstrated superiority compared with 48 weeks of peg-IFN alfa-2a monotherapy .


The optimal treatment strategy using nucleos ( t ) ide analogues and peg-IFN alfa-2a remains to be determined .


Clinical Trials Registration.NCT00614471 .


To observe the clinical efficacy differences among warming-promotion acupuncture , regular acupuncture and psychological care for post-earthquake depression .


Ninety cases of post-earthquake depression in Gansu province were randomly divided into a warming-promotion acupuncture group , a regular acupuncture group and a care group , 30 cases in each one .


The psychological treatment was applied in the care group ; the regular acupuncture at Baihui ( GV 20 ) , Sishencong ( EX-HN 1 ) ) , Fengchi ( GB 20 ) , Shenmen ( HT 7 ) , Yang-lingquan ( GB 34 ) , Taichong ( LR 3 ) and Sanyinjiao ( SP 6 ) was used in the regular acupuncture group ; based on the treatment of regular acupuncture group , the warming-promotion acupuncture was applied in the warming-promotion acupuncture group , once a day .


Ten days were taken as one course with an interval of two days between two courses .


Totally 3 treatment courses were completed .


The Hamilton depression ( HAMD ) scale before and after treatment in each group was observed while the efficacy was analyzed .


All three treatments were effective for depression .


The total cured rate was 86.67 % ( 26/30 ) in the warming-promotion acupuncture group , which was obviously superior to 50.00 % ( 15/30 ) in the regular acupuncture group ( P < 0.01 ) and 33.33 % ( 10/30 ) in the care group ( P < 0.001 ) .


After the treatment , the score of HAMD was all reduced in three groups , in which the effect in warming-promotion acupuncture group was superior to that in the regular acupuncture group and care group ( 9.02 + / - 2.37 vs 10.73 + / - 2.28 and 11.05 + / - 2.01 , P < 0.05 , P < 0.01 ) .


The warming-promotion acupuncture has positive effect on post-earthquake depression , which has special effect and is worthy of clinical generalization and application .


Previous open-label studies have suggested that quetiapine could be a valuable alternative for treating fibromyalgia .


This study aims to compare the efficacy and tolerability of extended-release quetiapine with amitriptyline for treating fibromyalgia .


This study was a randomized , open-label , flexible-dose , non-inferiority trial .


Patients with fibromyalgia were randomized to receive quetiapine extended-release ( XR ) ( N = 45 ) ( 50 to 300 mg daily ) or amitriptyline ( N = 45 ) ( 10 to 75 mg daily ) for 16 weeks .


The primary endpoint was the change from baseline to endpoint in the Fibromyalgia Impact Questionnaire ( FIQ ) total score ; the non-inferiority threshold was established at 8 points .


The secondary outcomes included sleep quality , anxiety , depression , and quality of life .


Twenty-two ( 49 % ) patients in the quetiapine group and 34 ( 76 % ) patients in the amitriptyline group completed the study .


We found a reduction of 9.8 points in the total FIQ score at the endpoint for the quetiapine-treated patients compared to 13.9 points for the amitriptyline-treated patients , for a difference of 4.14 points ( 80 % confidence interval ( CI ) -0.70 to 8.98 ) .


No significant differences were found between the quetiapine XR and amitriptyline groups for any of the secondary outcomes .


The proportion of patients discontinuing treatment due to adverse events was higher in the quetiapine group ( n = 14 , 31.1 % ) than the amitriptyline group ( n = 3 , 6.6 % ) .


Our results appear to indicate that quetiapine XR does not provide similar efficacy to amitriptyline for treating patients with fibromyalgia .


Quetiapine XR had a worse tolerability than amitriptyline in this population , possibly due to a relatively high starting dose .


Elderly people do not mount strong immune responses to vaccines .


We compared 23-valent capsular polysaccharide ( 23vPPV ) alone versus 7-valent conjugate ( PCV7 ) vaccine followed by 23vPPV 6 months later in hospitalized elderly .


Participants were randomized to receive 23vPPV or PCV7-23vPPV .


Antibodies against serotypes 3 , 4 , 6A , 6B , 9V , 14 , 18C , 19A , 19F , 23F were measured by enzyme-linked immunosorbent ( ELISA ) and opsonophagocytic ( OPA ) assays at baseline , 6 months and 12 months .


Of 312 recruited , between 40 % and 72 % of subjects had undetectable OPA titres at baseline .


After one dose , PCV7 recipients had significantly higher responses to serotypes 9V ( both assays ) and 23F ( OPA only ) , and 23vPPV recipients had significantly higher responses to serotype 3 ( ELISA ) , 19F and 19A ( OPA only ) .


In subjects with undetectable OPA titres at baseline , a proportionately greater rise in OPA titre ( P < 0.01 ) was seen for all serotypes after both vaccines .


The GMT ratio of OPA was significantly higher at 12 months in the PCV7-23vPPV group for serotypes 6A , 9V , 18C and 23F .


OPA titre levels for these serotypes increased moderately after 6 months , whereas immunity waned in the 23vPPV only arm .


We did not show overwhelming benefit of one vaccine over the other .


Low baseline immunity does not preclude a robust immune response , reiterating the importance of vaccinating the frail elderly .


A schedule of PCV7-23vPPV prevents waning of antibody , suggesting that both vaccines could be useful in the elderly .


Follow up studies are needed to determine persistence of immunity .


The Australian Clinical Trials Registry ACTRN12607000387426 .


The best criteria for surfactant treatment in the perinatal period are unknown and this makes it of interest to consider the possible economic implications of lessening the use of more restrictive criteria .


The objective of this study is the evaluation of the costs of respiratory care for preterm infants with Respiratory Distress Syndrome ( RDS ) treated with `` early rescue '' surfactant compared to a `` late rescue '' strategy .


The study was carried out applying the costs of materials used , of staff and pharmacological therapy calculated in the Neonatal Intensive Care Unit ( NICU ) of an Italian hospital to the Verder et al. study ( Pediatrics 1999 ) clinical data .


The cost for patients treated with early strategy was slightly lower than for patients treated with late strategy ( Euro 4,901.70 vs. Euro 4,960.07 ) .


The cost of treatment with surfactant was greater in the early group ( Euro 458.49 vs. Euro 311.74 ) , but this was compensated by the greater cost of treatment with Mechanical Ventilation ( MV ) in the late group ( respectively Euro 108.85 vs. Euro 259.25 ) .


The cost-effectiveness analysis performed in this study shows how early treatment with surfactant in preterm infants with RDS , as well as being clinically more effective , is associated with a slightly lower cost .


To evaluate the efficacy and safety of Arbidol ( umifenovir ) in adult patients with influenza .


The analysis of the preliminary results of the multicenter double-blind randomized placebo-controlled post-marketing study ARBITR was performed .


A total of 293 adults aged 18 to 65 years with influenza or acute respiratory tract infection of no more than 36 hours ' duration were enrolled in the study .


Individuals were randomized into 2 treatment groups : oral umifenovir 200 mg four times daily for 5 days or placebo four times daily for 5 days .


The efficacy endpoints were time to resolution of all symptoms , severity of symptoms and illness , durations of virus shedding .


The efficacy of umifenovir was evaluated in the group of 119 ( 40.6 % ) patients with influenza : 45 patients with laboratory-confirmed influenza and 74 patients whom diagnosis of influenza was made based on clinical and epidemiological data .


Umifenovir had influence on the time to resolution of all symptoms .


All symptoms were resolved within the first 60 hours after therapy initiation in 23.8 % patients with laboratory-confirmed influenza in the umifenovir group and it was 5.7 times greater compared to placebo group ( 4.2 % ) ( p < 0.05 ) .


Severity of illness , catarrhal symptoms and intoxication was reduced with umifenovir compared to placebo , reducing of severity was most evidently observed within the first 2-3 days following the therapy initiation .


Umifenovir had a significant effect on viral shedding .


The proportion of patients still shedding influenza virus on day 4 was significantly reduced in the umifenovir group compared to placebo ( 25 vs 53 % , respectively ; p < 0.05 ) .


It was found that the effect of umifenovir in the treatment of influenza in adults is most pronounced in the acute stage of the disease and appears in the reduction of time to resolution of all symptoms of the disease , reducing the severity of symptoms of the disease and durations of virus shedding .


Median OS after surgery in curative intent for non-metastasized pancreas cancer ranges under study conditions from 17.9 months to 23.6 months .


Tumor recurrence occurs locally , at distant sites ( liver , peritoneum , lungs ) , or both .


Observational and autopsy series report local recurrence rates of up to 87 % even after potentially `` curative '' R0 resection .


To achieve better local control , neoadjuvant CRT has been suggested for preoperative tumour downsizing , to elevate the likelihood of curative , margin-negative R0 resection and to increase the OS rate .


However , controlled , randomized trials addressing the impact of neoadjuvant CRT survival do not exist .


The underlying hypothesis of this randomized , two-armed , open-label , multicenter , phase III trial is that neoadjuvant CRT increases the three-year overall survival by 12 % compared to patients undergoing upfront surgery for resectable pancreatic cancer .


A rigorous , standardized technique of histopathologically handling Whipple specimens will be applied at all participating centers .


Overall , 410 patients ( n = 205 in each study arm ) will be enrolled in the trial , taking into regard an expected drop out rate of 7 % and allocated either to receive neoadjuvant CRT prior to surgery or to undergo surgery alone .


Circumferential resection margin status , i.e. R0 and R1 rates , respectively , surgical resectability rate , local and distant disease-free and global survival , and first site of tumor recurrence constitute further essential endpoints of the trial .


For the first time , the NEOPA study investigates the impact of neoadjuvant CRT on survival of resectable pancreas head cancer in a prospectively randomized manner .


The results of the study have the potential to change substantially the treatment regimen of pancreas cancer .


Clinical Trial gov : NCT01900327 , DRKS00003893 , ISRCTN82191749 .


Assess the safety , tolerability , and pharmacokinetic ( PK ) profiles of daclatasvir ( DCV ) and asunaprevir ( ASV ) in healthy male Japanese subjects .


AI444-007 and AI447-005 were phase I , double-blind , placebo-controlled , sequential , single-ascending dose ( SAD ) , and multiple-ascending dose ( MAD ) studies assessing DCV or ASV , respectively .


Eight subjects per panel were randomized to study drug or placebo ( 3 : 1 ) .


In the SAD part of each study , subjects received single oral dose DCV 1/10/50 / 100/200 mg or ASV 200/400/600 / 900/1 ,200 mg .


In MAD , subjects received 14-day oral multiple dose DCV 1/10/100 mg once-daily or ASV 200/400/600 mg every 12 hours .


Serial PK blood sampling occurred from predose to 72-hours postdose or post-last-dose .


Safety and tolerability was assessed throughout .


64 ( SAD , n = 40 ; MAD , n = 24 ) and 65 ( SAD , n = 40 ; MAD , n = 25 ) subjects were enrolled in AI444-007 and AI447-005 , respectively .


DCV and ASV were generally well tolerated , with no serious adverse events or clinicallyrelevant changes in vital signs or ECG parameters .


Baseline demographic characteristics were comparable across treatment groups in both studies .


DCV was readily absorbed , with median tmax of ~ 1 - 2 hours postdose and concentrations declining in a multi-phasic manner .


Exposure generally increased dose-proportionally within dose-range studied .


Steady-state was achieved between days 4 and 5 of multiple dosing .


ASV was readily absorbed , with median tmax of ~ 2 - 4 hours postdose and concentrations declining in a biphasic manner .


Steady-state appeared to be achieved between days 3 - 5 of multiple dosing .


Results suggest no clinically significant short-term safety signals with DCV and ASV at single or multiple doses in this population .


The use of animals to augment traditional medical therapies was reported as early as the 9th century but to our knowledge has not been studied in an orthopaedic patient population .


The purpose of this study was to evaluate the role of animal-assisted therapy using therapy dogs in the postoperative recovery of patients after THA and TKA .


We asked : ( 1 ) Do therapy dogs have an effect on patients ' perception of pain after total joint arthroplasty as measured by the VAS ?


( 3 ) Do therapy dogs have an effect on patients ' satisfaction with their hospital stay after total joint arthroplasty as measured by the Hospital Consumer Assessment of Healthcare Providers and Systems ( HCAHPS ) ?


A randomized controlled trial of 72 patients undergoing primary unilateral THA or TKA was conducted .


Patients were randomized to a 15-minute visitation with a therapy dog before physical therapy or standard postoperative physical therapy regimens .


Both groups had similar demographic characteristics .


Reduction in pain was assessed using the VAS after each physical therapy session , beginning on postoperative Day 1 and continuing for three consecutive sessions .


To ascertain patient satisfaction , the proportion of patients selecting top-category ratings in each subsection of the HCAHPS was compared .


Patients in the treatment group had lower VAS scores after each physical therapy session with a final VAS score difference of 2.4 units ( animal-assisted therapy VAS , 1.7 ; SD , 0.97 [ 95 % CI , 1.4-2 .0 ] versus control VAS , 4.1 ; SD , 0.97 [ 95 % CI , 3.8-4 .4 ] , p < 0.001 ) after the third physical therapy session .


Patients in the treatment group had a higher proportion of top-box HCAHPS scores in the following fields : nursing communication ( 33 of 36 , 92 % [ 95 % CI , 78 % -98 % ] versus 69 % , 25 of 36 [ 95 % CI , 52 % -84 % ] , p = 0.035 ; risk ratio , 1.3 [ 95 % CI of risk ratio , 1.0-1 .7 ] ; risk difference , 23 % [ 95 % CI of risk difference , 5 % -40 % ] ) , pain management ( 34 of 36 , 94 % [ 95 % CI , 81 % -99 % ] , versus 26 of 36 , 72 % [ 95 % CI , 55 % -86 % ] , p = 0.024 ; risk ratio , 1.3 [ 95 % CI of risk ratio , 1.1-1 .6 ] ; risk difference , 18 % [ 95 % CI of risk difference , 5 % -39 % ] ) .


The overall hospital rating also was greater in the treatment group ( 0-10 scale ) ( 9.6 ; SD , 0.7 [ 95 % CI , 9.3-9 .8 ] versus 8.6 , SD , 0.9 [ 95 % CI , 8.3-8 .9 ] , p < 0.001 ) .


The use of therapy dogs has a positive effect on patients ' pain level and satisfaction with hospital stay after total joint replacement .


Surgeons are encouraged to inquire about the status of volunteer-based animal-assisted therapy programs in their hospital as this may provide a means to improve the immediate postoperative recovery for a select group of patients having total joint arthroplasty .


Level II , randomized controlled study .


See Instructions for Authors for a complete description of levels of evidence .


The efficacy and safety of canagliflozin , a sodium glucose co-transporter 2 inhibitor , was evaluated in patients with type 2 diabetes mellitus ( T2DM ) inadequately controlled with metformin and pioglitazone .


In this randomized , double-blind , phase 3 study , patients ( N = 342 ) received canagliflozin 100 or 300mg during a 26-week , placebo-controlled , core period and a 26-week , active-controlled extension in which placebo-treated patients were switched to sitagliptin 100mg .


Efficacy comparisons for canagliflozin versus placebo at week 26 are reported , with no comparisons versus sitagliptin at week 52 ( sitagliptin used to maintain double-blind and control for safety ) .


Safety data are reported for canagliflozin and placebo/sitagliptin .


Canagliflozin 100 and 300mg significantly lowered haemoglobin A1c ( HbA1c ) compared with placebo at week 26 ( -0.89 % , -1.03 % and -0.26 % ; p < 0.001 ) ; reductions with canagliflozin 100 and 300mg were maintained at week 52 ( -0.92 % and -1.03 % ) .


Relative to placebo , both canagliflozin doses significantly reduced body weight ( -2.5 and -3.5 kg ) , fasting plasma glucose and systolic blood pressure ( BP ) at week 26 ( p < 0.05 for all ) , with reductions maintained at week 52 .


Overall adverse event ( AE ) incidence over 52 weeks was 69.9 , 76.3 and 76.5 % with canagliflozin 100 and 300mg and placebo/sitagliptin ; AE-related discontinuation and serious AE rates were low .


Incidences of genital mycotic infections and AEs related to osmotic diuresis and volume depletion were higher with canagliflozin than placebo/sitagliptin .


Canagliflozin improved glycaemic control , reduced body weight and systolic BP , and was generally well tolerated in patients with T2DM on metformin and pioglitazone over 52 weeks .


Delivery of a pharmacologically effective drug dosage to a target tissue is critical .


Barrett 's epithelia are a unique challenge for drug delivery of orally administered zinc due to rapid transit down the esophageal lumen , incomplete absorptive differentiation of these epithelia , and the use of proton-pump inhibitor drugs abrogating intestinal uptake of supplemental zinc .


Barrett 's esophagus patients were administered oral zinc gluconate ( 26 mg zinc twice daily ) for 14 days prior to biopsy procurement .


Barrett 's biopsies were analyzed for total zinc content by atomic absorption spectroscopy and by western immunoblot for cellular proteins known to be regulated by zinc .


Cellular levels of both the Znt-1 transport protein and the alpha isoform of PKC were over 50 % lower in the zinc treatment group .


Oral zinc administration can result in effective delivery of zinc to Barrett 's epithelia with resulting effects on intracellular signal transduction .


Ribavirin ( RBV ) remains part of several interferon-free treatment strategies even though its mechanisms of action are still not fully understood .


One hypothesis is that RBV increases responsiveness to type I interferons .


Pegylated Interferon alpha ( PEG-IFNa ) has recently been shown to alter natural killer ( NK ) cell function possibly contributing to control of hepatitis C virus ( HCV ) infection .


However , the effects of ribavirin alone or in combination with IFNa on NK cells are unknown .


Extensive ex vivo phenotyping and functional analysis of NK cells from hepatitis C patients was performed during antiviral therapy .


Patients were treated for 6 weeks with RBV monotherapy ( n = 11 ) , placebo ( n = 13 ) or PEG-IFNa-2a alone ( n = 6 ) followed by PEG-IFNa/RBV combination therapy .


The effects of RBV and PEG-IFNa-2a on NK cells were also studied in vitro after co-culture with K562 or Huh7 .5 cells .


Ribavirin monotherapy had no obvious effects on NK cell phenotype or function , neither ex vivo in patients nor in vitro .


In contrast , PEG-IFNa-2a therapy was associated with an increase of CD56bright cells and distinct changes in expression profiles leading to an activated NK cell phenotype , increased functionality and decline of terminally differentiated NK cells .


Ribavirin combination therapy reduced some of the IFN effects .


An activated NK cell phenotype during therapy was inversely correlated with HCV viral load .


PEG-IFNa activates NK cells possibly contributing to virological responses independently of RBV .


The role of NK cells during future IFN-free combination therapies including RBV remains to be determined .


Hyperoxemic management during cardiopulmonary bypass ( CPB ) is still common , and there is no consensus about physiologic oxygen tension strategy ( normoxemic management ) during pediatric CPB .


In this study , we compared the postoperative conditions and measures of inflammatory response among patients with acyanotic congenital heart disease subjected to either hyperoxemic or normoxemic management strategy during CPB .


We studied 22 patients with a ventricular septal defect and pulmonary artery hypertension .


The patients were divided into two groups .


Group I ( n = 9 ) received normoxemic management ( PaO2 = 100-150 mm Hg ) and group II ( n = 13 ) received hyperoxemic management ( PaO2 = 200-300 mm Hg ) during CPB .


There was no difference between groups with regard to age , body weight , duration of CPB , and aorta clamping time or preoperative pulmonary hypertension ( pulmonary pressure/systemic pressure [ Pp/Ps ] ) .


In each group , the blood samples to measure the cytokine levels were collected before and after the CPB .


Although we observed no statistically significant differences in postoperative intubation time , alveolar-arterial oxygen difference , creatine kinase MB level , and pulmonary hypertension ( Pp/Ps ) between group I ( 10.713.4 hours , 197132 mm Hg , 14858.6 IU/L , 42.8 % 22.1 % , respectively ) and group II ( 27.836.5 hours , 227150 mm Hg , 15172.6 IU/L , 50.4 % 16.0 % , respectively ) , levels of median interleukin 6 and tumor necrosis factor were lower in group I ( 129.8 and 17.0 pg/mL , respectively ) than that in group II ( 487.8 and 22.5 pg/mL , respectively ) .


During the CPB in acyanotic pediatric patients , normoxemic management can minimize the systemic inflammatory response syndrome associated with CPB .


We can apply this physiologic oxygen tension strategy to surgical advantage during heart surgeries in acyanotic pediatric patients .


Worsening heart failure ( WHF ) in the first 7 days after an admission for acute HF ( AHF ) has been proposed as a therapeutic target in several recent AHF studies and was a co-primary endpoint of the VERITAS studies .


Patients were randomized within 24h of admission for AHF .


WHF was defined as worsening or persistent signs and symptoms of HF requiring additional intravenous or mechanical therapy for HF or death within 7 days of randomization .


Multivariable models were developed to predict the time to WHF through day 7 .


Unadjusted and multivariable-adjusted associations of WHF with the length of stay ( LOS ) of the index hospitalization , and 30 - and 90-day outcomes were estimated .


WHF occurred by day 7 in 27 % of the 1347 patients enrolled .


Age , co-morbidities , and markers of HF severity were moderately predictive of WHF ; the C-index for a multivariable model for WHF was 0.66 .


After multivariable adjustment for baseline characteristics , WHF was associated with an increase in LOS of 4.33 days [ 95 % confidence interval ( CI ) 3.54-5 .13 days ] , a hazard ratio ( HR ) for 30-day HF readmission or death of 2.43 ( 95 % CI 1.75-3 .40 ) , and a HR for 90-day mortality of 2.57 ( 95 % CI 1.81-3 .65 ) , all with P < 0.0001 .


The associations of WHF with these outcomes remained largely unchanged after adjustment for both baseline characteristics and changes in markers of renal and hepatic dysfunction during the first day of admission .


In patients admitted for AHF , WHF is a significant clinical event that is associated with delays in discharge and higher rates for readmission and death .


Persons with mild dementia experience multiple losses and manifest depressive symptoms .


This research study aimed to evaluate the effectiveness of a support group led by a social worker for Chinese persons with mild dementia .


Participants were randomly assigned to either a ten-session support group or a control group .


Standardized assessment tools were used for data collection at pretreatment and post-treatment periods by a research assistant who was kept blind to the group assignment of the participants .


Upon completion of the study , 20 treatment group participants and 16 control group participants completed all assessments .


At baseline , the treatment and control groups did not show any significant difference on all demographic variables , as well as on all baseline measures ; over one-half ( 59 % ) of all the participants reported having depression , as assessed by a Chinese Geriatric Depression Scale score 8 .


After completing the support group , the depressive mood of the treatment group participants reduced from 8.83 ( standard deviation = 2.48 ) to 7.35 ( standard deviation = 2.18 ) , which was significant ( Wilcoxon signed-rank test ; P = 0.017 , P < 0.05 ) , while the control group 's participants did not show any significant change .


This present study supports the efficacy and effectiveness of the support group for persons with mild dementia in Chinese society .


In particular , this present study shows that a support group can reduce depressive symptoms for participants .


Green tea ( GT ) extract may play a role in body weight regulation .


Suggested mechanisms are decreased fat absorption and increased energy expenditure .


We examined whether GT supplementation for 12 wk has beneficial effects on weight control via a reduction in dietary lipid absorption as well as an increase in resting energy expenditure ( REE ) .


Sixty Caucasian men and women [ BMI ( in kg/m ) : 18-25 or > 25 ; age : 18-50 y ] were included in a randomized placebo-controlled study in which fecal energy content ( FEC ) , fecal fat content ( FFC ) , resting energy expenditure , respiratory quotient ( RQ ) , body composition , and physical activity were measured twice ( baseline vs. week 12 ) .


For 12 wk , subjects consumed either GT ( > 0.56 g/d epigallocatechin gallate + 0.28-0 .45 g/d caffeine ) or placebo capsules .


Before the measurements , subjects recorded energy intake for 4 consecutive days and collected feces for 3 consecutive days .


No significant differences between groups and no significant changes over time were observed for the measured variables .


Overall means SDs were 7.2 3.8 g/d , 6.1 1.2 MJ/d , 67.3 14.3 kg , and 29.8 8.6 % for FFC , REE , body weight , and body fat percentage , respectively .


GT supplementation for 12 wk in 60 men and women did not have a significant effect on FEC , FFC , REE , RQ , and body composition .


The optimum size of endotracheal tube ( ETT ) for general anesthesia remains unresolved .


Choice of ETT size may be of particular relevance to thyroid surgery because of the increased risk of laryngeal trauma and concerns regarding postoperative vocal outcomes .


To test our hypothesis that intubation with a smaller ETT would lead to reduced postoperative vocal impairment and associated reduced laryngoscopic evidence of laryngeal trauma compared with intubation with a standard-size ETT .


This double-blind randomized clinical trial studied patients 18 years and older undergoing elective thyroidectomy at an academic teaching hospital from October 15 , 2012 , through June 13 , 2013 .


Patients were randomized to group 1 ( standard-size ETT , 8.0 mm for men and 7.5 mm for women ; n = 24 ) or group 2 ( small ETT , 7.0 mm for men and 6.5 mm for women ; n = 25 ) .


Patients were assessed preoperatively and at 24 hours and 3 weeks postoperatively .


Fiberoptic videolaryngoscopy with modified scoring system , voice assessment using the GRBAS ( grade , roughness , breathiness , asthenia , strain ) rating scale , vocal self-assessment using the 30-item Voice Handicap Index , and subjective pain score .


At 24 hours , no significant differences were found between patients in groups 1 and 2 in change in GRBAS scores , change in laryngoscopic score ( 1.71 vs 1.76 , P = .90 ) , or postoperative pain score ( 3.3 vs 3.2 , P = .91 ) .


At 3 weeks , no significant differences were found in changes in the 30-item Voice Handicap Index score ( -2.2 vs -1.3 , P = .74 ) , GRBAS scores , or laryngoscopic score ( 0.25 vs 0.16 , P = .67 ) .


We did not find evidence that smaller ETT size for thyroidectomy has any significant effect on postoperative vocal outcomes , incidence of laryngeal trauma as assessed by laryngoscopy , or pain scores .


However , because of the small sample size , our study may have been underpowered to detect small differences .


clinicaltrials.gov Identifier : NCT02136459 .


Recent developments of open irrigated catheters have sought to create uniform cooling of the entire ablating electrode .


The aim of this randomized study was to assess whether the diffuse irrigation of the Coolflex ( ) ( CF ) catheter results in improved short-term procedural benefits in patients undergoing ablation of right atrial typical flutter .


Sixty consecutive patients ( age 62 13 ) with typical atrial flutter were prospectively randomized to ablation of the cavotricuspid isthmus ( CTI ) using either a standard 3.5 mm tip ablation catheter with six distal irrigation channels ( 6C ) ( 30 patients ) or a 4 mm tip fully irrigated ablation catheter ( CF ) ( 30 patients ) .


There were no significant differences seen between procedures performed with the diffusely irrigated CF catheter and the standard six-channel irrigated-tip catheter .


This concerned the total procedural duration RF duration , fluoroscopic duration , the total amount of irrigation fluid , and the occurrence of steam pop .


The use of a diffuse irrigation at the ablation catheter tip does neither facilitate lesion formation nor reduce the amount of irrigation during RF ablation for typical right atrial flutter using recommended flow and power settings .


To assess the association of the vitreomacular interface with outcomes of eyes treated with anti-vascular endothelial growth factor drugs for neovascular age-related macular degeneration ( AMD ) .


Prospective cohort study within a multicenter , randomized clinical trial .


Patients enrolled in the Comparison of AMD Treatments Trials ( CATT ) .


Treatment was assigned randomly as either ranibizumab or bevacizumab and as 3 different regimens for dosing over a 2-year period .


Masked readers at a reading center assessed optical coherence tomography ( OCT ) scans at baseline and follow-up for vitreomacular traction ( VMT ) and vitreomacular adhesion ( VMA ) , fluid , and central thickness .


Visual acuity ( VA ) was measured by masked , certified examiners .


Anatomic features and VA at baseline and 1 and 2 years and number of treatments .


At baseline , 143 patient eyes ( 12.8 % ) had VMT or VMA .


Compared with those with neither ( n = 972 ) , patients with VMT or VMA were younger ( mean standard error , 75.5 0.6 vs. 79.7 0.24 years ; P < 0.0001 ) and more likely to be male ( 52.4 % vs. 36.2 % ; P = 0.0003 ) , to be cigarette smokers ( 68.5 % vs. 55.3 % ; P = 0.003 ) , and to have subretinal fluid on OCT ( 86.7 % vs. 81.0 % ; P = 0.047 ) .


Vitreomacular interface status was not associated with VA at baseline or follow-up .


Among eyes treated as needed ( n = 598 ) and followed up for 2 years ( n = 516 ) , the mean number of injections was 15.4 0.9 for eyes having VMT at baseline or during follow-up ( n = 60 ) , 13.8 0.7 for eyes with VMA at baseline or follow-up ( n = 79 ) , and 12.9 0.4 ( P = 0.02 ) for eyes without VMT or VMA ( n = 377 ) .


In addition , the mean number of injections in eyes treated as needed increased from 13.0 0.3 when VMT was not observed to 13.6 1.3 when observed once and to 17 1.2 when observed more than once during follow-up .


At 2 years , geographic atrophy developed in a lower percentage of eyes with VMT or VMA at baseline ( 11.7 % ) than with neither condition ( 22.5 % ; P = 0.005 ) .


In eyes in the CATT , VMT and VMA were infrequent .


At baseline and follow-up , VMT or VMA were not associated with VA. .


Eyes with VMT or VMA treated as needed required on average 2 more injections over 2 years .


To evaluate the efficacy of resiniferatoxin in the treatment of patients with lifelong premature ejaculation .


A total of 41 outpatients ( mean age 26.144 years ) with premature ejaculation completed the present study .


They were randomly separated into the resiniferatoxin group and the placebo group .


The resiniferatoxin group included 11 patients with redundant prepuce and 10 patients without redundant prepuce , whereas the placebo group contained 10 patients with redundant prepuce and 10 patients without .


For the treatment , the glans were respectively soaked in 30mL of resiniferatoxin with a concentration of 100nmol/L or 10 % alcohol solution for 30min before sexual intercourse .


Clinical efficacy was assessed by using the Chinese Index of Sexual Function for Premature Ejaculation-5 and the intravaginal ejaculation latency time before or 4 weeks after the treatment .


The side-effects were also evaluated .


In the resiniferatoxin group , the effective rate of patients with redundant prepuce was 63.6 % , and both the intravaginal ejaculation latency time and Chinese Index of Sexual Function for Premature Ejaculation-5 significantly increased ( P < 0.05 ) .


However , the effective rate of patients without redundant prepuce was 20 % , and there were no significant changes of their intravaginal ejaculation latency time and Chinese Index of Sexual Function for Premature Ejaculation-5 before and after the resiniferatoxin treatment ( P > 0.05 ) .


The total effective rate of patients treated with resiniferatoxin was 42.9 % .


In the placebo group , the effective rate of patients with or without redundant prepuce was 20 % and 10 % , respectively .


The total effective rate of patients treated with placebo was 15 % , and there were no significant changes of their intravaginal ejaculation latency time and Chinese Index of Sexual Function for Premature Ejaculation-5 before and after the placebo treatment ( P > 0.05 ) .


The side-effects included a slight burning sensation for the glans penis and dysuria .


These preliminary results show that resiniferatoxin might be suitable for treating patients with lifelong premature ejaculation and particularly those with redundant prepuce .


Circumferential excisional hemorrhoidectomy ( CEH ) enables the surgeon to remove the encircling hemorrhoids completely .


The purpose of this study is to compare the efficacy of CEH with that of Ferguson hemorrhoidectomy ( FH ) for end-stage hemorrhoids .


Between February 1998 and December 2011 , a prospective randomized trial was conducted with 688 patients who presented with end-stage hemorrhoids and underwent FH or CEH at our center .


The patient demographics , mean operative times , lengths of hospital stay , and cumulative rates of postoperative complications were similar in the study groups .


Significant differences were revealed in the incidence of postoperative hemorrhage ( 9 vs. 0 patients in the FH and CEH groups , respectively ; p = 0.002 ) and in the tendency to form anal stricture ( 15 vs. 32 patients in the FH and CEH groups , respectively ; p = 0.02 ) .


However , all cases of anal strictures were easily managed by digital dilatations .


At a mean follow-up of 7.4 ( range , 1-14 ) years , accessible patients from the CEH group remained symptom free , whereas 126 of 308 patients in the FH group indicated that they had recurrent hemorrhoidal symptoms .


Without increasing postoperative complications , CEH demonstrates an advantage compared with FH , with regard to reducing the rate of recurrence to 0 through complete hemorrhoid removal .


In developing countries , accessibility to specialists , and physician to patient contact time is limited .


In Thailand , A unique community health service is provided by subdistrict health care officers and Village Health Volunteers ( VHVs ) .


If the personnel were trained on proper chronic kidney disease ( CKD ) care , CKD progression would be delayed .


We conducted a community-based , cluster randomized controlled trial at Kamphaeng Phet Province , located about 400 kilometers north of Bangkok .


Two out of eleven districts of the province were randomly selected .


Approximatly 500 stage 3-4 CKD patients from 2 districts were enrolled .


Patients in both groups will be treated with standard guidelines .


The patients in intervention group were provided the additional treatments by multidisciplinary team in conjunction with community CKD care network ( subdistrict health care officers and VHVs ) which will provide group counseling during each hospital visit and quarterly home visits to monitor dietary protein and sodium intake , blood pressure measurement and drug compliance .


Duration of the study is 2years .


The primary outcome is the difference of rate of eGFR decline .


The secondary outcomes are laboratory parameters and incidence of clinical endpoints such as mortality rate and cardiovascular events , end-stage renal disease ( ESRD ) , etc. .


Insights of this study may set forth a new standard of community-based CKD care .


NCT01978951 .


Patients with evidence of vascular disease are at increased risk for subsequent vascular events despite effective use of statins to lower the low-density lipoprotein ( LDL ) cholesterol level .


Niacin lowers the LDL cholesterol level and raises the high-density lipoprotein ( HDL ) cholesterol level , but its clinical efficacy and safety are uncertain .


After a prerandomization run-in phase to standardize the background statin-based LDL cholesterol-lowering therapy and to establish participants ' ability to take extended-release niacin without clinically significant adverse effects , we randomly assigned 25,673 adults with vascular disease to receive 2 g of extended-release niacin and 40 mg of laropiprant or a matching placebo daily .


The primary outcome was the first major vascular event ( nonfatal myocardial infarction , death from coronary causes , stroke , or arterial revascularization ) .


During a median follow-up period of 3.9 years , participants who were assigned to extended-release niacin-laropiprant had an LDL cholesterol level that was an average of 10 mg per deciliter ( 0.25 mmol per liter as measured in the central laboratory ) lower and an HDL cholesterol level that was an average of 6 mg per deciliter ( 0.16 mmol per liter ) higher than the levels in those assigned to placebo .


Assignment to niacin-laropiprant , as compared with assignment to placebo , had no significant effect on the incidence of major vascular events ( 13.2 % and 13.7 % of participants with an event , respectively ; rate ratio , 0.96 ; 95 % confidence interval [ CI ] , 0.90 to 1.03 ; P = 0.29 ) .


Niacin-laropiprant was associated with an increased incidence of disturbances in diabetes control that were considered to be serious ( absolute excess as compared with placebo , 3.7 percentage points ; P < 0.001 ) and with an increased incidence of diabetes diagnoses ( absolute excess , 1.3 percentage points ; P < 0.001 ) , as well as increases in serious adverse events associated with the gastrointestinal system ( absolute excess , 1.0 percentage point ; P < 0.001 ) , musculoskeletal system ( absolute excess , 0.7 percentage points ; P < 0.001 ) , skin ( absolute excess , 0.3 percentage points ; P = 0.003 ) , and unexpectedly , infection ( absolute excess , 1.4 percentage points ; P < 0.001 ) and bleeding ( absolute excess , 0.7 percentage points ; P < 0.001 ) .


Among participants with atherosclerotic vascular disease , the addition of extended-release niacin-laropiprant to statin-based LDL cholesterol-lowering therapy did not significantly reduce the risk of major vascular events but did increase the risk of serious adverse events .


( Funded by Merck and others ; HPS2-THRIVE ClinicalTrials.gov number , NCT00461630 . )


This study sought to assess the effect of the addition of coronary artery bypass grafting ( CABG ) to medical therapy on mode of death in heart failure .


Although CABG therapy is widely used in ischemic cardiomyopathy patients , there are no prospective clinical trial data on mode of death .


The STICH ( Surgical Treatment for Ischemic Heart Failure ) trial compared the strategy of CABG plus medical therapy to medical therapy alone in 1,212 ischemic cardiomyopathy patients with reduced ejection fraction .


A clinical events committee adjudicated deaths using pre-specified definitions for mode of death .


In the STICH trial , there were 462 deaths over a median follow-up of 56 months .


The addition of CABG therapy tended to reduce cardiovascular deaths ( hazard ratio [ HR ] : 0.83 ; 95 % confidence interval [ CI ] : 0.68 to 1.03 ; p = 0.09 ) and significantly reduced the most common modes of death : sudden death ( HR : 0.73 ; 95 % CI : 0.54 to 0.99 ; p = 0.041 ) and fatal pump failure events ( HR : 0.64 ; 95 % CI : 0.41 to 1.00 ; p = 0.05 ) .


Time-dependent estimates indicate that the protective effect of CABG principally occurred after 24 months in both categories .


Deaths post-cardiovascular procedures were increased in CABG patients ( HR : 3.11 ; 95 % CI : 1.47 to 6.60 ) , but fatal myocardial infarction deaths were lower ( HR : 0.07 ; 95 % CI : 0.01 to 0.57 ) .


Noncardiovascular deaths were infrequent and did not differ between groups .


In the STICH trial , the addition of CABG to medical therapy reduced the most common modes of death : sudden death and fatal pump failure events .


The beneficial effects were principally seen after 2 years .


Post-procedure deaths were increased in patients randomized to CABG , whereas myocardial infarction deaths were decreased .


To evaluate the effect of Chen 's needling therapy on facial neuritis .


Eighty-four patients of facial neuritis were randomized into a Chen 's needling therapy group and a conventional needling group , 42 cases in each one .


In the Chen 's needling therapy group , the few acupoints were selected ( 5 acupoints ) .


Chen 's flying insertion of needle and the reinforcing and reducing techniques were applied .


In the conventional needling group , the acupoint selection and needling method were used routinely .


The treatment of 1 month was 1 session in the two groups .


According to the symptom and physical sign quantification scale , the effect was assessed at multiple time points respectively ( in 2 weeks of treatment , 1 session of treatment and 1 month after 1 session of treatment ) .


Simultaneously , House-Brackmann scale and EMG were adopted to determine the function of facial nerve .


After treatment , the results of symptoms and physical sign quantification scale and facial nerve EMG were different significantly as compared with those before treatment in the patients of the two groups ( all P < 0.05 ) .


But the differences were not significant between the two groups ( all P > 0.05 ) .


Chen 's needling therapy achieves the same effect on facial neuritis as compared with the conventional acupuncture therapy , and additionally it is specialized at flying insertion of needle technique and selection of few acupoints .


In the Effects of Postconditioning on Myocardial Reperfusion in Patients with ST-segment Elevation Myocardial Infarction ( POST ) trial , ischemic postconditioning failed to improve myocardial reperfusion .


However , long-term effects of ischemic postconditioning on clinical outcomes are not known in patients with ST-segment elevation myocardial infarction .


A total of 700 patients undergoing primary percutaneous coronary intervention ( PCI ) were randomly assigned to the postconditioning group or the conventional primary PCI group in a 1:1 ratio .


Postconditioning was performed immediately after restoration of coronary flow by balloon occlusion 4 times for 1 minute .


Complete follow-up data for major clinical events at 1 year were available in 695 patients ( 99.3 % ) , and analyses were done by the intention to treat principle .


The primary outcome was a composite of death , myocardial infarction , severe heart failure , or stent thrombosis at 1 year .


At 1 year , a composite of death , myocardial infarction , severe heart failure , or stent thrombosis occurred in 21 patients ( 6.1 % ) in the postconditioning group and 16 patients ( 4.6 % ) in the conventional PCI group ( hazard ratio [ HR ] 1.32 , 95 % CI 0.69-2 .53 , P = .40 ) .


The risk of death ( 4.9 % vs 3.7 % , HR 1.32 , 95 % CI 0.64-2 .71 , P = .46 ) , heart failure ( 2.6 % vs 2.3 % , HR 1.13 , 95 % CI 0.44-2 .94 , P = .80 ) , and stent thrombosis ( 2.3 % vs 1.7 % , HR 1.34 , 95 % CI 0.46-3 .85 , P = .59 ) did not differ significantly between the 2 groups .


Ischemic postconditioning does not seem to improve the 1-year clinical outcomes in patients with ST-segment elevation myocardial infarction undergoing primary PCI .


To investigate the effectiveness of a worksite social and physical environment intervention on need for recovery ( i.e. , early symptoms of work-related mental and physical fatigue ) , physical activity and relaxation .


Also , the effectiveness of the separate interventions was investigated .


In this 2 2 factorial design study , 412 office employees from a financial service provider participated .


Participants were allocated to the combined social and physical intervention , to the social intervention only , to the physical intervention only or to the control group .


The primary outcome measure was need for recovery .


Secondary outcomes were work-related stress ( i.e. , exhaustion , detachment and relaxation ) , small breaks , physical activity ( i.e. , stair climbing , active commuting , sport activities , light/moderate/vigorous physical activity ) and sedentary behavior .


Outcomes were measured by questionnaires at baseline , 6 and 12 months follow-up .


Multilevel analyses were performed to investigate the effects of the three interventions .


In all intervention groups , a non-significant reduction was found in need for recovery .


In the combined intervention ( n = 92 ) , exhaustion and vigorous physical activities decreased significantly , and small breaks at work and active commuting increased significantly compared to the control group .


The social intervention ( n = 118 ) showed a significant reduction in exhaustion , sedentary behavior at work and a significant increase in small breaks at work and leisure activities .


In the physical intervention ( n = 96 ) , stair climbing at work and active commuting significantly increased , and sedentary behavior at work decreased significantly compared to the control group .


None of the interventions was effective in improving the need for recovery .


It is recommended to implement the social and physical intervention among a population with higher baseline values of need for recovery .


Furthermore , the intervention itself could be improved by increasing the intensity of the intervention ( for example weekly GMI-sessions ) , providing physical activity opportunities and exercise schemes , and by more drastic environment interventions ( restructuring entire department floor ) .


Nederlands Trial Register NTR2553 .


To observe the clinical effect on treatment of premature ovarian failure ( POF ) patients by Bushen Tiaojing Recipe ( BTR ) and hormone replacement therapy ( HRT ) .


Totally 72 POF patients were randomly assigned to three groups by random digit table , i.e. , the Chinese medicine group , the Western medicine group , and the integrative medicine group , 24 in each group .


Those in the Chinese medicine group took BTR .


Those in the Western medicine group were treated by HRT .


Those in the integrative medicine group were treated by BTR + HRT .


All were treated for three courses and followed-up for 3 months after treatment .


The clinical efficacy , integrals of clinical symptoms , and serum sex hormones levels [ follicular stimulating hormone ( FSH ) , estradiol ( E2 ) , luteinizing hormone ( LH ) ] were compared among the three groups before treatment , at the end of treatment , and 3 months after withdrawal .


( 1 ) The total effective rate was better in the integrative medicine group than in the Chinese medicine group and the Western medicine group ( P < 0.05 ) .


( 2 ) At the end of treatment , the integrals of clinical symptoms decreased in the 3 groups when compared with before treatment in the same group ( P < 0.05 , P < 0.01 ) .


The integrals of clinical symptoms were higher at 3 months after withdrawal than at the end of treatment in the Western medicine group ( P < 0.05 ) .


But there was no statistical difference in changes of integrals between the Chinese medicine group and the integrative medicine group ( P > 0.05 ) .


( 3 ) By the end of treatment serum E2 increased ( P < 0.01 ) , FSH and LH decreased ( P < 0.01 ) in the three groups , more significantly in the integrative medicine group and the Western medicine group ( P < 0.05 , P < 0.01 ) .


At 3 months after withdrawal serum E2 decreased , FSH and LH increased in the Western medicine group , showing statistical difference when compared with the other two groups ( P < 0.05 , P < 0.01 ) .


There was no statistical difference in changes of serum E2 , FSH , or LH between the Chinese medicine group and the integrative medicine group ( P > 0.05 ) .


BTR combined HRT had significant effect on treatment of POF , could significantly improve patients ' clinical symptoms , menstrual states , and serum sex hormones levels .


It had lower recurrence rate .


Patients suffered from less adverse reactions .


Benzodiazepines are considered first-line therapy for pediatric status epilepticus .


Some studies suggest that lorazepam may be more effective or safer than diazepam , but lorazepam is not Food and Drug Administration approved for this indication .


To test the hypothesis that lorazepam has better efficacy and safety than diazepam for treating pediatric status epilepticus .


This double-blind , randomized clinical trial was conducted from March 1 , 2008 , to March 14 , 2012 .


Patients aged 3 months to younger than 18 years with convulsive status epilepticus presenting to 1 of 11 US academic pediatric emergency departments were eligible .


There were 273 patients ; 140 randomized to diazepam and 133 to lorazepam .


Patients received either 0.2 mg/kg of diazepam or 0.1 mg/kg of lorazepam intravenously , with half this dose repeated at 5 minutes if necessary .


If status epilepticus continued at 12 minutes , fosphenytoin was administered .


The primary efficacy outcome was cessation of status epilepticus by 10 minutes without recurrence within 30 minutes .


The primary safety outcome was the performance of assisted ventilation .


Secondary outcomes included rates of seizure recurrence and sedation and times to cessation of status epilepticus and return to baseline mental status .


Outcomes were measured 4 hours after study medication administration .


Cessation of status epilepticus for 10 minutes without recurrence within 30 minutes occurred in 101 of 140 ( 72.1 % ) in the diazepam group and 97 of 133 ( 72.9 % ) in the lorazepam group , with an absolute efficacy difference of 0.8 % ( 95 % CI , -11.4 % to 9.8 % ) .


Twenty-six patients in each group required assisted ventilation ( 16.0 % given diazepam and 17.6 % given lorazepam ; absolute risk difference , 1.6 % ; 95 % CI , -9.9 % to 6.8 % ) .


There were no statistically significant differences in secondary outcomes except that lorazepam patients were more likely to be sedated ( 66.9 % vs 50 % , respectively ; absolute risk difference , 16.9 % ; 95 % CI , 6.1 % to 27.7 % ) .


Among pediatric patients with convulsive status epilepticus , treatment with lorazepam did not result in improved efficacy or safety compared with diazepam .


These findings do not support the preferential use of lorazepam for this condition .


clinicaltrials.gov Identifier : NCT00621478 .


Acetylcysteine has been suggested as a beneficial treatment for idiopathic pulmonary fibrosis , although data from placebo-controlled studies are lacking .


In our initial double-blind , placebo-controlled trial , we randomly assigned patients who had idiopathic pulmonary fibrosis with mild-to-moderate impairment in pulmonary function to receive a three-drug regimen of prednisone , azathioprine , and acetylcysteine ; acetylcysteine alone ; or placebo .


The study was interrupted owing to safety concerns associated with the three-drug regimen .


The trial continued as a two-group study ( acetylcysteine vs. placebo ) without other changes ; 133 and 131 patients were enrolled in the acetylcysteine and placebo groups , respectively .


The primary outcome was the change in forced vital capacity ( FVC ) over a 60-week period .


At 60 weeks , there was no significant difference in the change in FVC between the acetylcysteine group and the placebo group ( -0.18 liters and -0.19 liters , respectively ; P = 0.77 ) .


In addition , there were no significant differences between the acetylcysteine group and the placebo group in the rates of death ( 4.9 % vs. 2.5 % , P = 0.30 by the log-rank test ) or acute exacerbation ( 2.3 % in each group , P > 0.99 ) .


As compared with placebo , acetylcysteine offered no significant benefit with respect to the preservation of FVC in patients with idiopathic pulmonary fibrosis with mild-to-moderate impairment in lung function .


( Funded by the National Heart , Lung , and Blood Institute and others ; ClinicalTrials.gov number , NCT00650091 . )


The aim of this study was to evaluate marginal bone levels , with cone beam computed tomography , on the buccal and lingual aspects of implants placed with the implant-abutment interface ( IAI ) at different positions in relation to the alveolar crest .


Thirty patients in need of single-tooth rehabilitation were randomly assigned to three groups based on the position of the IAI in relation to the buccal aspect of the alveolar crest at the time of implant placement .


Patients in groups 0 , 1 , and 2 had their implants placed level with the buccal crest or 1 or 2 mm apical to the buccal aspect of the alveolar crest , respectively .


The implants were restored with screw-retained single crowns after 4 months .


Marginal bone levels on the buccal and lingual aspects of the implants were evaluated at 12 months after implant placement .


All groups of implants demonstrated significantly different crestal positions .


Group 2 implants maintained the greatest subcrestal position ( 1.33 0.86 mm ) compared to the implants of group 0 ( -0.04 0.18 mm ) and group 1 ( 0.34 0.44 mm ) .


There were no differences between groups in the level of the first bone-to-implant contact relative to the implant platform .


Implants of group 0 exhibited less buccal bone remodeling ( -0.08 0.25 mm ) compared to group 1 ( -0.65 0.45 mm ) and group 2 ( -0.85 0.75 mm ) implants .


For groups 1 and 2 implants , there was a significant negative correlation between buccal wall thickness following the osteotomy and the amount of buccal bone remodeling .


In this study , different responses were seen in the buccal and lingual peri-implant bone for implants with platform-switched Morse taper connections placed with the IAI at different locations in relation to the alveolar crest .


Evaluate antinociception , anesthesia , and recovery in llamas given tiletamine-zolazepam ( TZ ) with either morphine , xylazine , morphine and xylazine , or saline .


Randomized crossover experimental study .


Six healthy , adult intact male llamas .


Llamas were given each of four treatments intramuscularly with a 1-week washout : TZ ( 2 mg kg ( -1 ) ) combined with either morphine ( 0.5 mg kg ( -1 ) ; M ) , xylazine ( 0.15 mg kg ( -1 ) ; X ) , morphine ( 0.5 mg kg ( -1 ) ) and xylazine ( 0.15 mg kg ( -1 ) ) ( MX ) , or saline ( C ) .


Llamas breathed room air during the experiment .


Characteristics of anesthesia , recovery , and selected cardiopulmonary variables were recorded .


Antinociception was assessed by clamping a claw at 5-minute intervals .


Data were analyzed using a mixed-model anova and Tukey-Kramer test , and are expressed as least squares mean SEM .


Significance was set at p < 0.05 .


No llama in the control group demonstrated antinociception .


Antinociception was longest with treatment MX , followed by treatments X and M , respectively .


Heart rates in llamas given treatments X and MX were significantly lower than with other treatments .


The respiratory rate in llamas given treatment C was greater ( p < 0.05 ) than for all other treatments , however , the respiratory rate was not significantly different among treatments X , M and MX .


The PaO2 for llamas given MX remained < 60 mmHg throughout the 20 minute period of blood gas analysis .


Mean arterial blood pressure in llamas in treatment MX was less than for treatments M or C.


The combination of morphine ( 0.5 mg kg ( -1 ) ) and xylazine ( 0.15 mg kg ( -1 ) ) increased the duration of antinociception compared with xylazine alone , in TZ-anesthetized llamas .


Treatments X , M and MX were associated with hypoxemia ( PaO2 < 60 mmHg ) .


Current oral rotavirus vaccines perform suboptimally in resource-poor settings .


We investigated the effect of an additional dose and later schedule on the immunogenicity of monovalent rotavirus vaccine ( RV1 ) in a developing country .


Infants received RV1 at 6 and 10 , 10 and 14 , or 6 , 10 , and 14 weeks of age .


The primary objective was to compare antirotavirus immunoglobulin A ( IgA ) seroconversion at 18 weeks in the 6/10/14 arm to the cumulative seroconversion ( highest result at 14 or 18 weeks ) in the 6/10 arm .


Overall , 480 ( 76.2 % ) of 630 randomized infants completed the trial per protocol .


Seroconversion in the 6/10/14 arm was 36.7 % ( 95 % CI , 29.8 , 44.2 ) compared to 36.1 % ( CI , 29.0 , 43.9 ) in the 6/10 arm , ( P = 1.0 ) ; the result from the 10/14 arm was 38.5 % ( CI , 31.2 , 46.3 ) .


Seroconversion in the 6/10 arm at 14 weeks ( post hoc ) was lower at 29.7 % ( CI , 23.1 , 37.3 ) .


In Pakistani infants , the immunogenicity of RV1 did not increase significantly with 3 doses at 6 , 10 , and 14 weeks compared to 2 doses at 6 and 10 weeks .


Additional strategies should be evaluated for improving rotavirus vaccine immunogenicity in high burden countries .


The cholesterol absorption inhibitor ezetimibe has been shown to ameliorate non-alcoholic fatty liver disease ( NAFLD ) pathology in a single-armed clinical study and in experimental animal models .


In this study , we investigated the efficacy of ezetimibe on NAFLD pathology in an open-label randomised controlled clinical trial .


We had planned to enrol 80 patients in the trial , as we had estimated that , with this sample size , the study would have 90 % power .


The study intervention and enrolment were discontinued because of the higher proportion of adverse events ( significant elevation in HbA ( 1c ) ) in the ezetimibe group than in the control group .


Thirty-two patients with NAFLD were enrolled and randomised ( allocation by computer program ) .


Ezetimibe ( 10 mg/day ) was given to 17 patients with NAFLD for 6 months .


The primary endpoint was change in serum aminotransferase level .


Secondary outcomes were change in liver histology ( 12 control and 16 ezetimibe patients ) , insulin sensitivity including a hyperinsulinaemic-euglycaemic clamp study ( ten control and 13 ezetimibe patients ) and hepatic fatty acid composition ( six control and nine ezetimibe patients ) .


Hepatic gene expression profiling was completed in 15 patients using an Affymetrix gene chip .


Patients and the physician in charge knew to which group the patient had been allocated , but people carrying out measurements or examinations were blinded to group .


Serum total cholesterol was significantly decreased in the ezetimibe group .


The fibrosis stage and ballooning score were also significantly improved with ezetimibe treatment .


However , ezetimibe treatment significantly increased HbA1c and was associated with a significant increase in hepatic long-chain fatty acids .


Hepatic gene expression analysis showed coordinate downregulation of genes involved in skeletal muscle development and cell adhesion molecules in the ezetimibe treatment group , suggesting a suppression of stellate cell development into myofibroblasts .


Genes involved in the L-carnitine pathway were coordinately downregulated by ezetimibe treatment and those in the steroid metabolism pathway upregulated , suggestive of impaired oxidation of long-chain fatty acids .


Ezetimibe improved hepatic fibrosis but increased hepatic long-chain fatty acids and HbA1c in patients with NAFLD .


These findings shed light on previously unrecognised actions of ezetimibe that should be examined further in future studies .


University Hospital Medical Information Network ( UMIN ) Clinical Trials Registry UMIN000005250 .


The study was funded by grants-in-aid from the Ministry of Education , Culture , Sports , Science and Technology , Japan , and research grants from MSD .


To investigate whether the long term use of two dentifrices containing arginine , an insoluble calcium compound , and fluoride : ( 1 ) 1.5 % arginine and 1450 ppm F as sodium monofluorophosphate ( NaMFP ) in a dicalcium phosphate dihydrate ( dical ) base , and ( 2 ) 8.0 % arginine and 1450 ppm F as NaMFP in a calcium carbonate base , results in an increase in oral malodor potentially associated with increased ammonia production from breakdown of arginine , as compared to a commercially available fluoride dentifrice without arginine ( 1450 ppm F as NaMFP in a dical base ) , after 6 months of product use .


A 6-month clinical study , with 119 subjects , was conducted in Chengdu , China , using a double blind , randomized , parallel , three-treatment design .


A panel of four expert judges used a nine-point hedonic scale to evaluate breath odor using a protocol designed in concordance with the ADA Acceptance Program Guidelines for Product Used in the Management of Oral Malodor .


After a baseline evaluation , study subjects who scored above the threshold value for unpleasant breath odor were stratified by score and randomized into one of three treatment groups .


Subjects were provided with a soft-bristled manual toothbrush ( Colgate Classic Clean Toothbrush ) and brushed their teeth thoroughly in their regular and customary manner for 1 minute with their assigned dentifrice , twice daily .


Before breath-odor evaluations , the subjects refrained from eating odorigenic foods and did not use dental hygiene procedures , breath mints , or mouth rinses for 48 hours and 12 hours , respectively .


There was no statistically significant difference in oral malodor levels among subjects using the three dentifrices after 1 , 3 and 6 months of product use .


Recurrence rates of actinic keratosis ( AK ) lesions after cryosurgery are high , and this treatment does not address field cancerization .


We investigated the efficacy and safety of field treatment of AKs with ingenol mebutate gel following cryosurgery .


In this phase 3 , randomized , double-blind , vehicle-controlled study ( NCT01541553 ) , patients 18 years with four to eight clinically typical , visible , discrete AKs within a contiguous 25-cm2 treatment area on the face or scalp underwent cryosurgery followed 3 weeks later by once-daily ingenol mebutate 0.015 % or vehicle gel for 3 consecutive days .


Endpoints included complete clearance at week 11 and safety and efficacy over 12 months .


In 329 randomized patients , complete clearance rates were greater with ingenol mebutate than vehicle ( week 11 : 60.5 % vs 49.4 % ; P = .04 ; month 12 : 30.5 % vs 18.5 % ; P = .01 ) .


Fewer patients experienced the emergence of new lesions with ingenol mebutate than with vehicle ( 38.9 % vs 51.9 % ; P = .02 ) .


At month 12 , mean percentage reduction of AKs was higher with ingenol mebutate than with vehicle ( 68.2 % vs 54.1 % ; P = .002 ) .


The probability of remaining free of lesions was sustained longer with ingenol mebutate compared with vehicle gel : 78 % vs 68 % at 6 months ; 64 % vs 57 % at 9 months ; 55 % vs 40 % at month 12 , respectively .


Ingenol mebutate 0.015 % gel was well tolerated and no unexpected adverse events occurred ; all adverse events resolved within 2 weeks of starting treatment .


Field treatment with ingenol mebutate 0.015 % gel following cryosurgery significantly enhanced clearance of baseline lesions , and was well tolerated .


Furthermore , ingenol mebutate 0.015 % gel following cryosurgery reduced development of new lesions in the treated field .


Lecturing has been traditionally used as the core teaching strategy in university education in all disciplines .


However , new research in education suggests that other formats such as game teaching could be more effective .


To compare students ' performance , satisfaction and retention of knowledge between a Jeopardy! - style game format and a didactic lecture format in teaching the subject of models for organising patient care to fourth-year nursing students .


A parallel-group randomised controlled trial was conducted .


Participants were fourth-year nursing students who registered in the second semester of 2012-2013 and enrolled in the Nursing Management and Ethics in Nursing Course in the Community Health Department .


66 students completed the study ( 34 in the quiz game group and 32 in the lecture group ) .


Pre-test results showed no significant difference between the two groups in their achievement scores .


However , in the immediate achievement post-test and the retention test the students in the quiz group scored significantly better than those in the lecture group .


A satisfaction questionnaire showed that the game format was well liked and accepted by students as a more satisfying teaching method .


This study is the first of its kind in Jordan to explore the effectiveness of this particular game format versus the lecture format .


RESULTS suggest that the game format was well liked and accepted by students as a more satisfying teaching method .


Additionally , it appeared to be a better method of education as it promoted greater information retention .


Obesity and stress are among the most common lifestyle-related health problems .


Most of the current disease prevention and management models are not satisfactorily cost-effective and hardly reach those who need them the most .


Therefore , novel evidence-based controlled interventions are necessary to evaluate models for prevention and treatment based on self-management .


This randomized controlled trial examines the effectiveness , applicability , and acceptability of different lifestyle interventions with individuals having symptoms of metabolic syndrome and psychological distress .


The offered interventions are based on cognitive behavioral approaches , and are designed for enhancing general well-being and supporting personalized lifestyle changes .


339 obese individuals reporting stress symptoms were recruited and randomized to either ( 1 ) a minimal contact web-guided Cognitive Behavioral Therapy-based ( CBT ) intervention including an approach of health assessment and coaching methods , ( 2 ) a mobile-guided intervention comprising of mindfulness , acceptance and value-based exercises , ( 3 ) a face-to-face group intervention using mindfulness , acceptance and value-based approach , or ( 4 ) a control group .


The participants were measured three times during the study ( pre = week 0 , post = week 10 , and follow-up = week 36 ) .


Psychological well-being , lifestyles and habits , eating behaviors , and user experiences were measured using online surveys .


Laboratory measurements for physical well-being and general health were performed including e.g. liver function , thyroid glands , kidney function , blood lipids and glucose levels and body composition analysis .


In addition , a 3-day ambulatory heart rate and 7-day movement data were collected for analyzing stress , recovery , physical activity , and sleep patterns .


Food intake data were collected with a 48 - hour diet recall interview via telephone .


Differences in the effects of the interventions would be examined using multiple-group modeling techniques , and effect-size calculations .


This study will provide additional knowledge about the effects of three low intensity interventions for improving general well-being among individuals with obesity and stress symptoms .


The study will show effects of two technology guided self-help interventions as well as effect of an acceptance and value-based brief group intervention .


Those who might benefit from the aforesaid interventions will increase knowledge base to better understand what mechanisms facilitate effects of the interventions .


Current Clinical Trials NCT01738256 , Registered 17 August , 2012 .