For genotype 2 HCV , samatasvir was active in subjects with NS5A L31 polymorphism at baseline ( individual range 2.5-4 .1 log10/ml ) , but showed minimal activity in those with baseline M31 polymorphism .


Samatasvir exhibited a long plasma half-life of approximately 20h which supports once daily dosing .


Samatasvir was well tolerated in all subjects with no safety-related discontinuations or serious adverse events .


The most common adverse events included constipation , nausea and headache and occurred at similar frequency in active and placebo subjects .


All events were mild or moderate in intensity .


There were no patterns or dose dependence of adverse events , vital signs , laboratory parameters or electrocardiograms .


Samatasvir 25-100mg monotherapy for 3days was well tolerated and induced a rapid and profound reduction in plasma HCV RNA in subjects infected with HCV genotype 1-4 .


Samatasvir is being evaluated in combination with other direct-acting antiviral agents in subjects with HCV infection .


Hospital to Home ( H2H ) is a national quality improvement ( QI ) initiative composed of three recommended hospital interventions to improve the transition of care for hospitalized patients with heart disease .


A study was conducted to determine if enrollment of Department of Veterans Affairs ( VA ) hospitals in H2H and adoption of the recommended interventions would both increase following facilitation of an existing Heart Failure ( HF ) provider-based community of practice ( COP ) within the VA health care system .


The VA HF COP includes more than 800 VA providers and other VA staff from VA inpatient medical centers .


In 2010 , 122 VA hospitals were randomized to facilitation using the VA HF COP ( intervention ) or no facilitation ( control ) .


COP members from intervention hospitals were invited to periodic teleconferences promoting H2H and received multiple e-mails asking members to report interest and then progress in H2H implementation .


Among the 61 hospitals randomized to HF COP facilitation , 33 ( 54 % ) enrolled in H2H , compared with 6 ( 10 % ) of 61 control hospitals ( p < .001 ) at five months after randomization .


Of 38 intervention hospitals responding to the follow-up survey , 13 stated they had initiated 22 QI projects as a result of the H2H campaign .


Another 7 hospitals had planned H2H projects .


Of 20 control hospitals that responded , 5 had initiated 9 projects as a result of H2H , and no additional hospitals had plans to do so .


Facilitation using the VA HF COP was successful in increasing enrollment in the H2H initiative and providing implementation support for recommended QI projects .


Multihospital provider groups are a potentially valuable tool for implementation of national QI campaigns .


To assess the relationship between infant feeding , triple-antiretroviral prophylaxis and weight from 2 weeks ( baseline ) to 6 months postpartum among HIV-infected mothers in a mother-to-child transmission ( MTCT ) of HIV-prevention trial in five sub-Saharan African sites .


HIV-infected pregnant women with CD4 cell counts of 200-500cells / l were counselled to choose breastfeeding to 6 months or replacement feeding from delivery .


They were randomized to receive perinatal zidovudine and single-dose nevirapine or triple-antiretroviral MTCT prophylaxis until breastfeeding cessation .


Mixed-effect linear models were used to compare maternal weight trajectories over time by infant feeding mode .


Antiretroviral prophylaxis and BMI at baseline were examined as potential effect modifiers .


Among 797 mothers , 620 ( 78 % ) initiated breastfeeding .


Wasting ( BMI < 18.5 ) was rare at baseline ( 2 % ) , whereas overweight/obesity ( BMI25 ) was common ( 40 % ) .


In the model including all women , breastfeeding was not associated with weight loss up to 6 months , irrespective of baseline BMI and antiretroviral prophylaxis .


Triple-antiretroviral prophylaxis was associated with weight gain among replacement-feeding mothers with baseline BMI at least 25 ( +0.54 kg/month ; P < 0.0001 ) .


In the model including breastfeeding mothers only , triple-antiretroviral prophylaxis was associated with weight gain among mothers with baseline BMI at least 25 who ceased breastfeeding before 3 months postpartum ( +0.33 kg/month ; P = 0.03 ) .


The results suggest that breastfeeding up to 6 months postpartum is not detrimental for postpartum weight among well nourished HIV-infected mothers at intermediate-disease stage .


In the absence of breastfeeding or after weaning , triple-antiretroviral prophylaxis is associated with weight gain among women with high BMI , even after cessation of prophylaxis .


To compare the effectiveness of adding cyclobenzaprine , tizanidine , or placebo to patient education and a self-care management program for patients with myofascial pain and specifically presenting with jaw pain upon awakening .


Forty-five patients with a diagnosis of myofascial pain based on the guidelines of the American Academy of Orofacial Pain participated in this 3-week study .


The subjects were randomly assigned into one of three groups : placebo group , TZA group ( tizanidine 4 mg ) , or CYC group ( cyclobenzaprine 10 mg ) .


Patients were evaluated for changes in pain intensity , frequency , and duration by using the modified Severity Symptoms Index and changes in sleep quality with the use of the Pittsburgh Sleep Quality Index .


Data were analyzed by ANOVA and post-hoc or nonparametric statistical tests as appropriate .


All three groups had a reduction in pain symptoms and improvement of sleep quality based on a comparison of pretreatment and treatment scores .


However , no significant differences among the groups were observed at the posttreatment evaluation .


The use of tizanidine or cyclobenzaprine in addition to self-care management and patient education was not more effective than placebo for the management of patients with myofascial jaw pain upon awakening .


A controlled , clinical , double blind study was conducted to assess the efficacy of a sugar-free chewing gum containing calcium hydroxyapatite on dentin hypersensitivity , versus a placebo chewing gum with no active ingredients , after one and two weeks .


One hundred and seven subjects joined the trial and were allocated into the test or the control ( placebo ) group by a random table .


The test chewing gum contained calcium hydroxyapatite and dicalcium phosphate dihydrate ; the control chewing gum was identical , but without those ingredients .


Participants were required to chew two pieces of their assigned chewing gum three times a day .


Dentin hypersensitivity was evaluated following three clinical test indexes ( tactile , air blast , cold water ) and one subjective index .


One hundred subjects completed the study with 50 allocated to each group .


The clinical test index reductions after one and two weeks in the test group were , respectively , 36 % and 54 % for tactile , 35 % and 66 % for air blast , and 24 % and 49 % for cold water .


The clinical test index reductions after one and two weeks in the control group were , respectively , 16 % and 30 % for tactile , 11 % and 25 % for air blast , and 14 % and 31 % for cold water .


These reductions at one and two weeks were significant for the test group ( p < 0.01 ) .


For the control group they were significant ( p < 0.01 ) only at two weeks .


The comparisons between the groups at two weeks showed a significant statistical difference between the test and the control gum for tactile ( p < 0.01 ) , for air blast ( p < 0.001 ) , for cold water ( p < 0.05 ) , and for the subjective index ( p < 0.05 ) .


In this trial , the group using the chewing gum containing calcium hydroxyapatite had a statistically significant reduction in all clinical test indexes for dentin hypersensitivity after one and two weeks , and a statistically significant reduction compared to the control gum group .


To compare the effectiveness ofradial extracorporeal shock wave therapy ( rSWET ) and ultrasound therapy ( US ) in the treatment of chronic plantar fasciitis .


Randomized controlled trial .


Department of Rehabilitation Medicine , King Chulalongkorn Memorial Hospital .


Thirty patients who were diagnosed with plantar fasciitis for at least 3 months and who had not responded to other forms of conservative treatment were recruited for this study .


They were randomly divided into two groups of 15 patients .


The rESWT group was treated with 1 session per week and the US group with 3 sessions per week , with both groups undergoing a total of 6 consecutive weeks of treatment .


Visual analog scale ( VAS ) assessments were performed before and after treatment at 1 , 3 , 6 , 12 , and 24 weeks .


The mobility subscale of the plantar fasciitis pain and disability scale ( PFPS ) was measured before and after treatment .


Patient satisfaction was evaluated at the conclusion of the 6-week treatment protocol .


VAS pain intensity scores were significantly decreased in both groups ( p < 0.001 ) , when measured after treatment at 1 , 3 , 6 , 12 , and 24 weeks .


The VAS pain scores for the rESWT group dropped significantly more than those of the US group ( p < 0.001 ) .


At the end of treatment , the PFPS mobility subscale scores in both groups were significantly decreased ( p < 0.001 ) .


Similar to the VAS pain score outcome , the PFPS mobility subscale score for the rESWT group decreased significantly more than that of the US group ( p < 0.001 ) .


Patient satisfaction was significantly higher in the rESWT group , relative to the US group ( p = 0.025 ) .


In chronic plantar fasciitis treatment , both rESWT and US were found to be effective in reducing pain and increasing mobility ; however , statistical analysis showed that rESWT is significantly more effective than US .


For older adults , the damaging effects of aging and stress can impair the ability to learn and sustain memory .


Humor , with its associated mirthful laughter , can reduce stress and cortisol , a stress hormone .


Chronic release of cortisol can damage hippocampus neurons , leading to impairment of learning and memory .


The primary goal of this study was to determine whether watching a humorous video had an effect on short-term memory in an older population .


The research team designed a randomized , controlled trial .


The study took place at Loma Linda University in Loma Linda , California .


The research team recruited 20 normal , healthy , older adults , 11 males and 9 females .


The humor group ( n = 10 , mean = 69.3 3.7 y ) self-selected 1 of 2 humorous videos -- a Red Skelton comedy or a montage of America 's Funniest Home Videos -- and watched it for 20 min .


A control group ( n = 10 , mean = 68.7 5.5 y ) sat calmly for 20 min and were not allowed to read , sleep , or talk on a cell phone .


The Rey Auditory Verbal Learning Test was used to assess short-term memory -- learning ability , delayed recall , and visual recognition .


Salivary cortisol levels were measured at predetermined times .


Learning ability improved by 38.5 % and 24.0 % in the humor and control groups , respectively ( P = .014 ) .


Delayed recall improved by 43.6 % and 20.3 % in the humor and control groups , respectively ( P = .029 ) .


Within the humor group , delayed recall ( 43.6 % ) was significant compared with learning ability ( 38.5 % ) ( P = .002 ) .


At 3 predetermined time points , significant decreases in salivary cortisol were observed in the humor group ( P = .047 , P = .046 , and P = .062 , respectively ) .


The study 's findings suggest that humor can have clinical benefits and rehabilitative implications and can be implemented in programs that support whole-person wellness for older adults .


Learning ability and delayed recall are important to these individuals for a better quality of life -- considering mind , body , spirit , social , and economic aspects .


Older adults may have age-associated memory deficiencies .


However , medical practitioners now can offer positive , enjoyable , and beneficial humor therapies to improve these deficiencies .


The purpose of this study was to investigate whether probiotics had an effect on proinflammatory markers and cytokines in overweight and obese individuals and whether they could have synergistic effects with weight-loss diets .


A total of 75 healthy overweight and obese individuals completed this randomized doubled-blind controlled clinical trial .


Participants were randomly assigned to groups consuming regular yogurt with a low-calorie diet ( LCD , RLCD ; n = 25 ) or receiving probiotic yogurt with LCD ( PLCD ; n = 25 ) or consuming probiotic yogurt without LCD ( PWLCD ; n = 25 ) for 8 weeks .


The pribiotic regimen contained 200 g/day yogurt , enriched by Lactobacillus acidophilus La5 , Bifidobacterium BB12 , and Lactobacillus casei DN001 10 ( 8 ) colony-forming units/g .


Body fat percentage , high-sensitive C-reactive protein ( hs-CRP ) , tumor necrosis factor-alpha ( TNF - ) , leptin , and mRNA levels of inflammation-related genes ( TNF - and RAR-related orphan receptor gamma [ ROR-t ] ) in peripheral blood mononuclear cells ( PBMCs ) were measured .


A reduction in body mass index ( BMI ) , fat percentage , and leptin level was observed that was more obvious in groups who received the weight-loss diet with probiotic yogurt .


Reduction in the gene expression of ROR-t was significant in the PLCD group ( p < 0.001 ) .


The expression of TNF - did not change among all groups after intervention .


The mean concentration of leptin was significantly decreased in all groups after the dietary intervention , but the mean changes in leptin level in the PLCD group was more prominent compared to the other two groups ( -2.38 , p < 0.001 [ PLCD ] vs -1.75 , p = 0.002 [ RLCD ] and -0.55 ng/mL , p = 0.12 [ PWLCD ] ) .


The reduction in serum levels of hs-CRP was more evident in the PWLCD group compared to the PLCD and RLCD groups after the 8-week intervention ( -3.4 , p = 0.03 vs -1.76 , p < 0.001 and -2.98 pg/mL , p < 0.001 , respectively ) .


Our results suggested that the weight-loss diet and probiotic yogurt had synergistic effects on T-cells subset specific gene expression in PBMCs , fat percentage , and body weight among overweight and obese individuals .


Media literacy programs have shown potential for reduction of adolescent tobacco use .


We aimed to determine if an anti-smoking media literacy curriculum improves students ' media literacy and affects factors related to adolescent smoking .


We recruited 1170 9th-grade students from 64 classrooms in 3 public urban high schools .


Students were randomized by classroom to a media literacy curriculum versus a standard educational program .


In an intent-to-treat analysis , we used multilevel modeling to determine if changes in study outcomes were associated with the curricular intervention , controlling for baseline student covariates and the clustering of students within classrooms .


Among participants , mean age was 14.5 years and 51 % were male , with no significant differences in baseline characteristics between groups .


Smoking media literacy changed more among intervention participants compared with control participants ( 0.24 vs. 0.08 , p < .001 ) .


Compared with controls , intervention students exhibited a greater reduction in the perceived prevalence of smoking ( -14.0 % vs. -4.6 % , p < .001 ) .


Among those initially susceptible to smoking , intervention participants more commonly reverted to being nonsusceptible post-intervention ( 24 % vs. 16 % , p = .08 ) .


A school-based media literacy curriculum is more effective than a standard educational program in teaching media literacy and improving perceptions of the true prevalence of smoking among adolescents .


We sought to determine and compare clinical profile and management of outpatients with heart failure with reduced ejection fraction ( HFREF ) treated by cardiologists and general practitioners ( GPs ) in Poland .


All the 790 randomly selected cardiologists and GPs in the DATA-HELP registry , which included 5563 patients , filled out questionnaires about 10 consecutive outpatients with HFREF .


Outpatients managed by GPs were older ( 6910 vs 6612 years ) , and the prevalence of men was less marked ( 58 % vs 67 % ) .


They also had higher left ventricular ejection fraction ( 386 % vs 358 % ) and had more pulmonary congestion ( 63 % vs 49 % ) and peripheral oedema ( 66 % vs 51 % ) , compared with those treated by cardiologists ( all p < 0.001 ) .


Hypertension ( 74 % vs 66 % ) , previous stroke and/or transient ischaemic attack ( 21 % vs 16 % ) , diabetes ( 40 % vs 30 % ) , and chronic obstructive pulmonary disease ( 14 % vs 11 % ) were more common in outpatients of GPs ( all p < 0.001 ) .


GPs were less likely to prescribe - blocker ( 95 % vs 97 % , p < 0.01 ) , mineralocorticoid receptor antagonist ( MRA ) ( 56 % vs 64 % , p < 0.001 ) , and loop diuretic ( 61 % vs 64 % , p < 0.05 ) or use PCI ( 33 % vs 44 % , p < 0.001 ) , CABG ( 11 % vs 16 % , p < 0.001 ) , ICD ( 4 % vs 10 % , p < 0.001 ) , or CRT ( 1 % vs 5 % , p < 0.001 ) .


Prescription of renin-angiotensin system inhibitors ( 94 % vs 94 % , p > 0.2 ) and digoxin ( 20 % vs 21 % , p > 0.2 ) by GPs and cardiologists was similar .


In contemporary Poland , most outpatients with HFREF receive drugs that improve survival and undergo revascularisation procedures , although devices are rare , but the clinical profiles and management of those treated by GPs and cardiologists differ .


Outpatients treated by GPs are older and have more co-morbidities .


Outpatients treated by cardiologists more commonly receive - blocker , MRA , ICD , and CRT , and undergo coronary revascularisations .


Robust clinical data evaluating fibrosis progression in hepatitis C virus ( HCV ) liver transplant patients receiving an mTOR inhibitor vs. calcineurin inhibitor ( CNI ) are lacking .


To evaluate fibrosis progression in maintenance liver transplant patients receiving everolimus - or CNI-based immunosuppression .


In a randomised , multicentre , open-label study , 43 maintenance liver transplant patients with recurrent HCV infection were randomised to continue CNI-based immunosuppression or switch to everolimus .


For patients with biopsy data at month 12 , mean Ishak-Knodell fibrosis score at baseline was 2.6 0.9 ( n = 14 ) with everolimus vs. 1.9 1.1 ( n = 18 ) with CNI ( P = 0.043 ) , and 1.9 1.2 vs. 2.2 1.3 at month 12 .


Ishak-Knodell fibrosis score decreased from baseline to month 12 by a mean of -0.7 1.1 with everolimus , but increased by 0.2 1.2 with CNI ( P = 0.046 ) .


No acute rejection or graft losses occurred up to month 12 .


Estimated GFR at month 12 was 65.6 ml/min/1 .73 m with everolimus and 62.2 ml/min/1 .73 m with CNI [ mean difference 3.4 ml/min/1 .73 m compared to CNI control group , 95 % CI -4.9 , 11.8 ml/min/1 .73 m , P = 0.411 ( analysis of covariance adjusting for baseline GFR ) ] .


Adverse events occurred in 95.5 % of everolimus patients and 71.4 % of CNI patients ( serious adverse events 31.8 % and 0.0 % , respectively ) .


Adverse events led to everolimus discontinuation in five patients ( 22.7 % ) .


This exploratory study suggests that conversion from CNI to everolimus reduces progression of liver fibrosis , and preserves renal function without jeopardising efficacy in liver transplant recipients with recurrent HCV , but is associated with a higher incidence of adverse events and serious adverse events .


These preliminary findings merit examination in a larger trial .


In this study , we evaluated the effect on cognitive function of memantine , behavioral and psychological symptoms of dementia , and the care burden , in patients with moderate-to-severe Alzheimer 's disease ( AD ) .


Furthermore , with near-infrared spectroscopy ( NIRS ) , we examined the association between effect of memantine and brain blood flow .


We evaluated the effect of memantine administration from baseline on Clinical Global Impression-Improvement scale , mini mental state examination ( MMSE ) , Clock Drawing Test ( CDT ) , Neuropsychiatric Inventory ( NPI ) , Japanese version of the Zarit Burden Interview ( J-ZBI ) and NIRS in two groups , donepezil administration memantine combination group ( combination group , n = 19 ) donepezil administration memantine non-administration group ( control group , n = 18 ) were assessed at weeks 0 , 4 , 12 , and 24 .


Significant difference was found between the combination group and the control group in the score variation of Clinical Global Impression-Improvement scale , MMSE , CDT , NPI , and J-ZBI .


In the NIRS measurements , trend oxyhemoglobin reduced suppression was observed in some channels centered on the superior frontal gyrus .


A significant correlation was observed in the scores of MMSE , CDT , NPI , and J-ZBI .


In addition , a significant positive correlation was also observed between the number of words in NIRS and scores of MMSE and CDT .


In this study , by administering memantine in AD patients that inhibit the reduction of cerebral blood flow in the prefrontal area and improve clinical symptoms overall cognitive function , behavioral and psychological symptoms of dementia , thereby reducing the care burden of caregivers was suggested .


This study compared the timing of onset of antiplatelet action after treatment with clopidogrel and prasugrel at first medical contact in patients with ST-segment elevation myocardial infarction ( STEMI ) scheduled for primary percutaneous coronary intervention ( PPCI ) .


Little is known about the timing of onset of antiplatelet action after a pre-percutaneous coronary intervention ( PCI ) loading dose of clopidogrel or prasugrel in patients with STEMI .


This double-blind , prospective study randomized 62 patients with STEMI scheduled for PPCI in the ambulance or the emergency department to 60 mg prasugrel ( n = 31 ) or 600 mg clopidogrel ( n = 31 ) .


The primary endpoint was the platelet reactivity index ( PRI ) measured with the vasodilator-stimulated phosphoprotein assay 2 h after intake of the study medication .


Secondary endpoints were PRI after 4 h , TIMI ( Thrombolysis In Myocardial Infarction ) patency of the infarct-related artery before and after PCI , and clinical events until day 30 .


The PRI after 2 h ( 50.4 32.7 % vs. 66.3 22.2 % ; p = 0.035 ) and after 4 h ( 39.1 27.5 % vs. 54.5 49.3 % ; p = 0.038 ) were significantly lower with prasugrel compared with clopidogrel .


In addition , the rate of patients with a PRI < 50 % tended to be higher with prasugrel compared with clopidogrel after 2 h ( 46.7 % vs. 28.6 % ; p = 0.15 ) and after 4 h ( 63.0 % vs. 38.9 % ; p = 0.06 ) .


There were no significant differences in TIMI 2/3 patency before PCI ( 39.2 % vs. 31.0 % ; p = 0.43 ) and TIMI 3 patency after PCI ( 88.5 % vs. 89.3 % ; p = 0.92 ) .


The pre-PCI administration of prasugrel in patients with STEMI undergoing PPCI was associated with a significant faster platelet inhibition compared with clopidogrel .


Therefore , prasugrel should be preferred to clopidogrel in this setting .


( ETAMI-Study : Early Thienopyridine Treatment to Improve Primary PCI in Patients With Acute Myocardial Infarction ; NCT01327534 ) .


To test the effectiveness of cognitive-behavioral counseling on the rate and duration of exclusive breastfeeding ( EBF ) during the first 6 months of an infant 's life compared with routine counseling .


A single blind cluster-randomized controlled trial was undertaken in 40 Union Councils of a rural district in the northwest province of Pakistan between May 2009 and April 2010 .


By simple unmatched randomization , 20 Union Councils were each allocated to intervention and control arms .


Two hundred twenty-four third trimester pregnant women in the intervention and 228 third trimester pregnant women in the control arm were enrolled and followed-up biweekly until 6 months postpartum .


Analyses were by intention to treat .


Mothers in the intervention group received 7 sessions of cognitive-behavioral counseling from antenatal to 6 months postpartum , whereas the control group received an equal number of routine sessions .


Proportion of mothers exclusively breastfeeding at 6 months postpartum and duration of EBF through these 6 months was assessed .


At 6 months postpartum , 59.6 % of mothers in the intervention arm and 28.6 % in the control arm were exclusively breastfeeding .


This translates into a 60 % reduced risk of stopping exclusively breastfeeding during the first 6 months ( adjusted hazard ratio , 0.40 [ 95 % confidence interval : 0.27-0 .60 ] , P < .001 ) .


Mothers in the intervention group were half as likely to use prelacteal feeds with their infants ( adjusted relative risk , 0.51 [ 95 % confidence interval : 0.34-0 .78 ] ) .


Compared with routine counseling , cognitive-behavioral counseling significantly prolonged the duration of EBF , doubling the rates of EBF at 6 months postpartum .


The aim of this study was to determine the incidence and seasonal pattern of malaria in children in South-West Burkina Faso , and to compare , in a randomized trial , characteristics of cases detected by active and passive surveillance .


This study also enabled the planning of a malaria vaccine trial .


Households with young children , located within 5 kilometers of a health facility , were randomized to one of two malaria surveillance methods .


In the first group , children were monitored actively .


Each child was visited twice weekly ; tympanic temperature was measured , and if the child had a fever or history of fever , a malaria rapid diagnostic test was performed and a blood smear collected .


In the second group , children were monitored passively .


The child 's parent or caregiver was asked to bring the child to the nearest clinic if he was unwell .


Follow up lasted 13 months from September 2009 .


Incidence of malaria ( Fever with parasitaemia 5,000 / L ) was 1.18 episodes/child/year in the active cohort and 0.89 in the passive cohort ( rate ratio 1.32 , 95 % CI 1.13-1 .54 ) .


Malaria cases in the passive cohort were more likely to have high grade fever ; but parasite densities were similar in the two groups .


Incidence was highly seasonal ; when a specific case definition was used , about 60 % of cases occurred within the 4 months June-September .


Passive case detection required at least a 30 % -40 % increase in the sample size for vaccine trials , compared to active detection , to achieve the same power .


However we did not find any evidence that parasite densities were higher with passive than with active detection .


The incidence of malaria is highly seasonal and meets the WHO criteria for Seasonal Malaria Chemoprevention ( SMC ) .


At least half of the malaria cases in these children could potentially be prevented if SMC was effectively deployed .


To study the effects of topical intranasal mometasone furoate nasal spray for management of otitis media with effusion in children aged 2-12 years with adenoidal hypertrophy and its impact on change in quality of life .


A prospective randomized double blind interventional placebo control study was conducted .


Hundred patients of endoscopic grade 3 or 4 adenoidal hypertrophy aged 2-12 years were enrolled in this study .


Among these sixty two patients had persistent bilateral otitis media with effusion more than three months .


These were randomly divided into two groups , group A and group B. Group A received mometasone nasal spray for six months and group B received saline nasal spray for the same period .


Patients were evaluated with symptom , pure tone audiometry wherever possible , pneumatic otoscopic examination and tympanogram at 0 , 8 and 24 weeks .


Resolution of otitis media with effusion in study group ( 28 out of 30 ) was significantly higher as compared control group ( 16 out of 32 ) ( p value 0.0004 ) .


A significant improvement in hearing and symptoms was seen in the study group ( p < 0.04 ) .


Statistically significant change in quality of life was seen with mometasone nasal spray ( 37.11 ) as compared to saline nasal spray ( 11.02 ) ( p value 0.0001 ) .


Mometasone nasal spray appears to be effective for the treatment of otitis media with effusion in patients of adenoidal hypertrophy .


Conventional methods of caries removal are commonly associated with pain , fear and discomfort .


Chemomechanical methods were introduced to instill a positive dental attitude .


Agents like GK-101 , Caridex , Carisolv did not prove effective alternatives owing to their high cost , need of special instruments and taste of chlorine .


A new chemomechanical agent , Papacarie , has been introduced to overcome these deficiencies .


This study was aimed to compare the effectiveness and tolerance of Papacrie with the conventional method .


25 children with at least two primary teeth with broad cavitated occlusal or cervical lesion were selected .


One carious tooth from each patient was randomly treated with each of Papacarie and conventional drilling method , one after the other .


Time taken for caries excavation , child 's pain perception , change in anxiety levels , microbial flora and child 's preference of treatment were recorded separately for both the methods .


Although the mean time taken for caries removal by the Papacarie method was slightly longer ( P0 .05 ) but it led to reduction in pain and anxiety ( p < 0.05 ) .


The viable bacterial counts were significantly reduced by either of the two methods ( P < 00001 ) .


More patients preferred Papacarie over conventional method of treatment ( P < 0.05 ) .


Papacrie method seems to be a better alternative to conventional method of caries removal .


To determine whether functional electrical stimulation ( FES ) - assisted active cycling is more effective than active cycling without FES concerning walking and balance .


Specifically , walking ability was classified as to the amount of personal assistance needed to be able to walk and balance was evaluated for static and dynamic balance tasks .


Monocentric , randomized , single-blinded , controlled trial .


Neurologic rehabilitation hospital .


Patients with severe hemiparesis due to stroke ( N = 40 ) .


Twenty minutes of active leg cycling with or without FES applied to the paretic vastus medialis and rectus femoris of quadriceps and to the biceps femoris and semitendinosus muscles , 3 times/wk for 4 weeks .


Functional ambulation classification ( FAC ) and performance-oriented mobility assessment ( POMA ) were the primary outcome measures .


The leg subscale of the motricity index ( MI ) and the modified Ashworth scale were the secondary outcome measures .


Evaluation was done before and after the intervention period and after an additional 2 weeks .


After the intervention , the FAC , POMA , and the MI ( P < .016 ) for both intervention groups improved significantly .


The FAC of the control group increased by a median of 1 category and that of the FES group by 2 categories .


The median change in POMA was 2 and 4 points for the control group and the FES group , respectively .


The Mann-Whitney U test between-group comparisons revealed that these gains were significantly better in the FES group for both the FAC ( U = 90 ; z = -2.58 ; P = .013 ; r = -.42 ) and the POMA ( U = 60 ; z = -3.43 ; P < .0004 ; r = -.56 ) .


Because of missing data and slightly decreased effect sizes during the follow-up phase ( FAC , r = -.33 ; POMA , r = -.41 ) , differences did not reach statistically significant P values .


The MI leg subscale showed significant improvements in both groups .


However , there were no significant differences between the groups at any time .


No changes were observed on the modified Ashworth scale .


FES-assisted active cycling seems to be a promising intervention during rehabilitation in patients with stroke .


We previously reported the initial results of the first multicenter , randomized , double-blind , placebo-controlled clinical trial of peanut sublingual immunotherapy ( SLIT ) , observing a favorable safety profile associated with modest clinical and immunologic effects in the first year .


We sought to provide long-term ( 3-year ) clinical and immunologic outcomes for our peanut SLIT trial .


Key end points were ( 1 ) percentage of responders at 2 years ( ie , could consume 5 g of peanut powder or a 10-fold increase from baseline ) , ( 2 ) percentage reaching desensitization at 3 years , ( 3 ) percentage attaining sustained unresponsiveness after 3 years , ( 4 ) immunologic end points , and ( 5 ) assessment of safety parameters .


Response to treatment was evaluated in 40 subjects aged 12 to 40 years by performing a 10-g peanut powder oral food challenge after 2 and 3 years of daily peanut SLIT therapy .


At 3 years , SLIT was discontinued for 8 weeks , followed by another 10-g oral food challenge and an open feeding of peanut butter to assess sustained unresponsiveness .


Approximately 98 % of the 18,165 doses were tolerated without adverse reactions beyond the oropharynx , with no severe symptoms or uses of epinephrine .


A high rate ( > 50 % ) discontinued therapy .


By study 's end , 4 ( 10.8 % ) of 37 SLIT-treated participants were fully desensitized to 10 g of peanut powder , and all 4 achieved sustained unresponsiveness .


Responders at 2 years showed a significant decrease in peanut-specific basophil activation and skin prick test titration compared with nonresponders .


Peanut SLIT induced a modest level of desensitization , decreased immunologic activity over 3 years in responders , and had an excellent long-term safety profile .


However , most patients discontinued therapy by the end of year 3 , and only 10.8 % of subjects achieved sustained unresponsiveness .


To compare the safety and efficacy of U.S. Food and Drug Administration ( FDA ) - recommended doses of labetalol and nicardipine for hypertension ( HTN ) management in a subset of patients with renal dysfunction ( RD ) .


Randomized , open label , multicenter prospective clinical trial .


Thirteen United States tertiary care emergency departments .


Subgroup analysis of the Evaluation of IV Cardene ( Nicardipine ) and Labetalol Use in the Emergency Department ( CLUE ) clinical trial .


The subjects were 104 patients with RD ( i.e. , creatinine clearance < 75 mL/min ) who presented to the emergency department with a systolic blood pressure ( SBP ) 180 mmHg on 2 consecutive readings and for whom the emergency physician felt intravenous antihypertensive therapy was desirable .


The FDA recommended doses of either labetalol or nicardipine for HTN management .


The number of patients achieving the physician 's predefined target SBP range within 30 minutes of treatment .


Patients treated with nicardipine were within target range more often than those receiving labetalol ( 92 % vs. 78 % , P = 0.046 ) .


On 6 SBP measures , patients treated with nicardipine were more likely to achieve the target range on either 5 or all 6 readings than were patients treated with labetalol ( 46 % vs. 25 % , P = 0.024 ) .


Labetalol patients were more likely to require rescue medication ( 27 % vs. 17 % , P = 0.020 ) .


Adverse events thought to be related to either treatment group were not reported in the 30-minute active study period , and patients had slower heart rates at all time points after 5 minutes ( P < 0.01 ) .


In severe HTN with RD , nicardipine-treated patients are more likely to reach a target blood pressure range within 30 minutes than are patients receiving labetalol .


Within 30 minutes of administration , nicardipine is more efficacious than labetalol for acute blood pressure control in patients with RD. .


Dementia affects 35 million people worldwide and is currently incurable .


Many cases may be preventable because regular participation in physical , mental and social leisure activities during middle age is associated with up to 47 % dementia risk reduction .


However , the majority of middle-aged adults are not active enough .


MCI is therefore a clear target for activity interventions aimed at reducing dementia risk .


An active lifestyle during middle age reduces dementia risk but it remains to be determined if increased activity reduces dementia risk when MCI is already evident .


Before this can be investigated conclusively , complex multimodal activity programmes are required that ( 1 ) combine multiple health promoting activities , ( 2 ) engage people with MCI , and ( 3 ) result in sufficient adherence rates .


We designed the ThinkingFit programme to engage people with MCI in a complex intervention comprised of three activity components : physical activity , group-based cognitive stimulation ( GCST ) and individual cognitive stimulation ( ICST ) .


Engagement and adherence was promoted by applying specific psychological techniques to enhance behavioural flexibility in an early pre-phase and during the course of the intervention .


To pilot the intervention , participants served as their own controls during a 6 - to 12-week run-in period , which was followed by 12weeks of activity intervention .


Out of 212 MCI patients screened , 163 were eligible , 70 consented and 67 completed the intervention ( mean age 74years ) .


Activity adherence rates were high : physical activity = 71 % ; GCST = 83 % ; ICST = 67 % .


Significant treatment effects ( p < .05 ) were evident on physical health outcomes ( decreased BMI and systolic blood pressure , [ pre/post values of 26.3 / 25.9 kg/m2 and 145/136mmHg respectively ] ) , fitness ( decreased resting and recovery heart rate [ 68/65bpm and 75/69bpm ] ) , and cognition ( improved working memory [ 5.3 / 6.3 items ] ) .


We found satisfactory recruitment , retention and engagement rates , coupled with significant treatment effects in elderly MCI patients .


It appears feasible to conduct randomized controlled trials of the dementia prevention potential of complex multimodal activity programmes like ThinkingFit .


ClinicalTrials.gov registration nr : NCT01603862 ; date : 17/5/2012 .


To evaluate the clinical and microbiological effects of systemic levofloxacin ( LFX ) in subjects with Aggregatibacter actinomycetemcomitans-associated chronic periodontitis ( AA-ACP ) .


Subjects with severe periodontitis with subgingival detection of A. actinomycetemcomitans were randomly divided into two treatment groups ; a test group ( n = 35 ) that received scaling and root planing ( SRP ) and LFX ( 500 mg o.d. ) and a control group ( n = 34 ) that received SRP and placebo ( o.d. ) for 10 days .


Plaque index ( PI ) , gingival index ( GI ) , percent of sites with bleeding on probing ( % BoP ) , probing depth ( PD ) and clinical attachment level ( CAL ) were recorded and subgingival plaque samples were cultivated for detection of A. actinomycetemcomitans at baseline to 6 months at various intervals .


Subjects receiving LFX showed the greatest improvements in mean PD and CAL .


The difference in the reduction of PD and CAL in the two groups was significant at 1 , 3 and 6 months for PD and 3 and 6 months for CAL ( p < 0.05 ) .


The inter-group difference in PI , GI and % BoP was not significant at any interval .


Detectable levels of A. actinomycetemcomitans were significantly less in the test group 3 and 6 months post-therapy .


Systemic LFX as an adjunct to SRP improves clinical outcomes and suppresses A. actinomycetemcomitans below detectable levels .


Driving under the influence ( DUI ) enforcement practices and sanctions contribute differentially to the certainty , swiftness , and severity of punishment , which are the key components of general deterrence theory .


This study used a conjoint experiment to understand the decision-making process of potential DUI offenders and tested how variation in enforcement and legal punishment affects drinking and driving decisions .


It sought to verify and quantify the unique deterrent effects of certainty , severity , and swiftness and to predict the rates of drinking and driving in different legal environments .


One hundred twenty-one college seniors and graduate students at the University of Maryland participated in the Web-based conjoint experiment .


They were randomly assigned to 4 blocks , each of which included 9 hypothetical scenarios composed of different levels of DUI enforcement and penalties .


Respondents were asked to state their likelihood of drinking and driving under each scenario , as well as their estimated chance of being caught by the police for DUI .


Intensified enforcement , harsh jail penalty , and immediate long license suspension were found to be the strongest deterrents to drinking and driving .


Alternative ways to get home were also important in reducing people 's willingness to drive .


These factors accounted for most of the attribute effect on the DUI decision , whereas delayed punishment due to judicial processing , fine penalty , and legal blood alcohol concentration ( BAC ) limit had negligible effects .


For the personal characteristics , college seniors and those who had previously driven after drinking were more likely to choose to drink and drive , whereas those who expect a jail penalty for a DUI offense were less likely to drive .


Our research confirmed and quantified certainty of punishment as the greatest deterrent to DUI , but it also indicated the equally important effect of a severe jail penalty .


It provides evidence on the feasibility of using a conjoint experiment in future studies to understand the general driver population and , with the help of a simulation tool , to predict DUI decisions in different legal environments .


Such predictions can be used to better inform policy decisions on developing targeted general deterrence programs in different communities .


Infant responses to vaccines can be impeded by maternal antibodies and immune system immaturity .


It is therefore unclear whether human immunodeficiency virus type 1 ( HIV-1 ) vaccination would elicit similar responses in adults and infants .


HIV-1 Env-specific antibody responses were evaluated in 2 completed pediatric vaccine trials .


In the Pediatric AIDS Clinical Trials Group ( PACTG ) 230 protocol , infants were vaccinated with 4 doses of Chiron rgp120 with MF59 ( n = 48 ) , VaxGen rgp120 with aluminum hydroxide ( alum ; n = 49 ) , or placebo ( n = 19 ) between 0 and 20 weeks of age .


In PACTG 326 , infants received 4 doses of ALVAC-HIV-1 / AIDSVAX B/B with alum ( n = 9 ) or placebo ( n = 13 ) between 0 and 12 weeks of age .


By 52 weeks of age , the majority of maternally acquired antibodies had waned and vaccine Env-specific immunoglobulin G ( IgG ) responses in vaccinees were higher than in placebo recipients .


Chiron vaccine recipients had higher and more-durable IgG responses than VaxGen vaccine recipients or ALVAC/AIDSVAX vaccinees , with vaccine-elicited IgG responses still detectable in 56 % of recipients at 2 years of age .


Remarkably , at peak immunogenicity , the concentration of anti-V1V2 IgG , a response associated with a reduced risk of HIV-1 acquisition in the RV144 adult vaccine trial , was 22-fold higher in Chiron vaccine recipients , compared with RV144 vaccinees .


As exemplified by the Chiron vaccine regimen , vaccination of infants against HIV-1 can induce robust , durable Env-specific IgG responses , including anti-V1V2 IgG .


Adverse events during colonoscopy are more likely to occur in elderly .


To avoid the adverse events without decreasing the bowel cleanliness is still an unsolved problem .


The aim of this study was to determine the effect of enteral nutrition before colonoscopy in a randomized controlled trail .


A total of 108 patients over sixty-five years of age and indicated for colonoscopy were randomized into four groups .


Group 1 received a solution of two packages of polyethylene glycol electrolyte powder dissolved in 2000 mL water .


Group 2 received 500 mL of enteral nutrition plus polyethylene glycol of the same dosage as in group 1 .


Group 3 received 200 mL of 25 % magnesium sulfate solution .


Group 4 received 500 mL of enteral nutrition plus 25 % magnesium sulfate solution of the same dosage as in group 3 .


The intestinal cleaning and various physiological indications were measured before , after bowel preparation , and during colonoscopy .


No significant difference in the quality of colon cleansing was found among the four groups .


The incidence of adverse effects in groups 2 and 4 was less than in groups 1 and 3 .


Additional enteral nutrition in elderly patients before bowel preparation did not affect the quality of colon cleansing .


However , the process can significantly reduce the incidence of adverse effects .


Endoscopic variceal ligation ( EVL ) is effective in preventing esophageal variceal rebleeding .


However , the optimal EVL interval remains unclear .


To investigate the effectiveness and safety of EVL using two intersession intervals .


methods : From January 2009 to October 2012 , 214 patients with acute esophageal variceal bleeding were screened .


Emergency ligation was performed for patients with acute variceal bleeding .


After achieving hemodynamic stability , eligible patients ( n = 70 ) were randomized to either the monthly group or the biweekly group .


Median time from randomization to variceal obliteration was 2.7 months in the monthly group and 1.7 months in the biweekly group , at a mean of 2.3 2.0 and 3.0 1.8 sessions , respectively .


After a median follow up of 23 months , six patients ( 17 % ) in the monthly group and nine patients ( 26 % ) in the biweekly group developed upper gastrointestinal rebleeding ( P = 0.382 ) .


Esophageal variceal rebleeding occurred in six patients ( 17 % ) in the monthly group and in seven patients ( 20 % ) in the biweekly group ( P = 0.759 ) .


No rebleeding from EVL ulcers occurred in the monthly group and was 5.7 % ( n = 2 ) for the biweekly group .


Both treatment groups had similar rates of esophageal variceal recurrence and mortality .


Notably , the incidence of post-EVL ulcers in the monthly group was lower than that in the biweekly group ( 11 % vs 57 % , P < 0.001 ) .


Patients receiving EVL monthly had similar rebleeding rate , variceal recurrence , and mortality to those receiving EVL biweekly for secondary prophylaxis of variceal bleeding ; however , the monthly interval was associated with fewer post-EVL ulcers found at follow-up endoscopies .


The aim of this pilot study was to evaluate the effect of low-level laser therapy on pain , mandibular movements , and occlusal contacts in adolescents and young adults with temporomandibular disorder .


Individuals aged 14 to 23 years were evaluated .


The Research Diagnostic Criteria for Temporomandibular Disorders were used for the diagnosis of temporomandibular disorders .


Pain was assessed with a visual analog scale .


Occlusal contacts were recorded using the T-Scan III program ( Tekscan , Boston , MA ) .


The participants were randomly allocated to 2 groups : active or placebo laser treatment .


The laser parameters were as follows : wavelength of 780 nm , energy density of 33.5 J/cm ( 2 ) , power of 50 mW , power density of 1.67 W/cm ( 2 ) , and 20-second exposure time .


The Kolmogorov-Smirnov test was used to determine the normality of the data distribution .


The paired t test was used for the comparisons of the pretreatment and post-treatment results .


The SPSS program for Windows ( version 15.0 ; SPSS , Chicago , IL ) was used for all analyses , with the level of significance set at 5 % ( P < .05 ) .


No statistically significant differences between groups were found for the right and left anterior temporal muscles ( P = .3801 and P = .5595 , respectively ) , superior masseter muscles ( P = .087 and P = .1969 , respectively ) , medial masseter muscles ( P = .2241 and P = .076 , respectively ) , or inferior masseter muscles ( P = .5589 and P = .3268 , respectively ) after treatment .


No statistically significant differences were found regarding pain , mandibular range of motion , or the distribution of occlusal contacts after treatment with low-level laser therapy .


These preliminary results need to be verified in a larger sample of patients to confirm the lack of response to low-level laser therapy .


External stents inhibit saphenous vein graft ( SVG ) intimal hyperplasia in animal studies .


We investigated whether external stenting inhibits SVG diffuse intimal hyperplasia 1 year after coronary artery bypass graft surgery .


Thirty patients with multivessel disease undergoing coronary artery bypass graft surgery were enrolled .


In addition to an internal mammary artery graft , each patient received one external stent to a single SVG randomly allocated to either the right or left coronary territories ; and one or more nonstented SVG served as the control .


Graft patency was confirmed at the end of surgery in all patients .


The primary endpoint was SVG intimal hyperplasia ( mean area ) assessed by intravascular ultrasonography at 1 year .


Secondary endpoints were SVG failure , ectasia ( > 50 % initial diameter ) , and overall uniformity as judged by Fitzgibbon classification .


One-year follow-up angiography was completed in 29 patients ( 96.6 % ) .


All internal mammary artery grafts were patent .


Overall SVG failure rates did not differ significantly between the two groups ( 30 % stented versus 28.2 % nonstented SVG , p = 0.55 ) .


The SVG mean intimal hyperplasia area , assessed in 43 SVGs , was significantly reduced in the stented group ( 4.37 1.40 mm ( 2 ) ) versus nonstented group ( 5.12 1.35 mm ( 2 ) , p = 0.04 ) .


In addition , stented SVGs demonstrated marginally significant improvement in lumen uniformity ( p = 0.08 ) and less ectasia ( 6.7 % versus 28.2 % , p = 0.05 ) .


There was some evidence that ligation of side branches with metallic clips increased SVG failure in the stented group .


External stenting has the potential to improve SVG lumen uniformity and reduce diffuse intimal hyperplasia 1 year after coronary artery bypass graft surgery .


This study aims at investigating the effect of a single pre-operative oral administration of morphine sulphate ( Oramorph ) on pain after laparoscopic cholecystectomy ( LC ) .


Forty-one ASA I-III patients , aged 18-65 years , undergoing LC were randomly , double-blindly allocated to treatment ( N. = 20 , 30mg Oramorph , group M ) or placebo ( N. = 21 , group P ) .


General anesthesia was maintained with propofol and remifentanil .


All patients received ketamine 0.2 mg/kg iv at induction , intraoperative ketorolac 30mg iv and tramadol postoperatively ( iv PCA : bolus 50 mg , lock-out 30 min , max 100 mg/4 hours ) .


Numerical rating scale for pain ( NRS ) , White 's fast track and PADSS scores , tramadol consumption and adverse events were recorded for the first 24h .


All patients underwent State Trait Anxiety Inventory ( STAI ) and Mini Mental State Examination ( MMSE ) .


Anthropometric characteristics , MMSE , STAI , ASA status , NRS rest , White 's and PADDS scores , PONV incidence were similar .


Group M showed significantly lower NRS on movement during the first 3 hours after awakening .


Cumulative tramadol consumption was lower in group M than in group P ( 185142 mg versus 263199 mg , P = 0.199 ) .


Within a multimodal approach , a single preoperative oral administration of 30 mg of morphine sulphate in patients undergoing LC did not improve pain at rest , but improved NRS on movement during the first 3 hours after awakening .


Group P required a higher mean dose of tramadol compared to Group M , although not significantly .


The safety profile of Oramorph allowed fast extubation and awakening times as well as prompt home discharge within 6 hours from surgery .


Further survival benefits may be gained from low-dose chest computed tomography ( CT ) by assessing vertebral fractures and bone density .


We sought to assess the association between CT-measured vertebral fractures and bone density with all-cause mortality in lung cancer screening participants .


Following a case-cohort design , lung cancer screening trial participants ( N = 3,673 ) who died ( N = 196 ) during a median follow-up of 6 years ( inter-quartile range : 5.7-6 .3 ) were identified and added to a random sample of N = 383 from the trial .


We assessed vertebral fractures using Genant 's semiquantative method on sagittal reconstructions and measured bone density ( Hounsfield Units ( HU ) ) in vertebrae .


Cox proportional hazards modelling was used to determine if vertebral fractures or bone density were independently predictive of mortality .


The prevalence of vertebral fractures was 35 % ( 95 % confidence interval 30-40 % ) among survivors and 51 % ( 44-58 % ) amongst cases .


After adjusting for age , gender , smoking status , pack years smoked , coronary and aortic calcium volume and pulmonary emphysema , the adjusted hazard ratio ( HR ) for vertebral fracture was 2.04 ( 1.43-2 .92 ) .


For each 10 HU decline in trabecular bone density , the adjusted HR was 1.08 ( 1.02-1 .15 ) .


Vertebral fractures and bone density are independently associated with all-cause mortality .


Lung cancer screening chest computed tomography contains additional , potentially useful information .


Vertebral fractures and bone density are independently predictive of mortality .


This finding has implications for screening and management decisions .


Irritable bowel syndrome ( IBS ) is a common gastrointestinal functional disorder with no effective therapy .


Traditional Chinese medicine ( TCM ) is one of the most common complementary therapies in China .


We designed this study to evaluate the efficacy and safety of Shun-Qi-Tong-Xie Granule ( SQTX Granule ) , a TCM treatment , in patients with IBS with diarrhea ( IBS-D ) .


A randomised , double-blinded , placebo-controlled , multi-centre , superiority clinical trial to evaluate the efficacy and safety of SQTX Granule is proposed .


Eligible patients ( Rome III ) with IBD-S will be randomly assigned into SQTX Granule group and the placebo group .


Patients will receive a 28-day treatment and a 2-month follow-up .


The primary outcome measures include the scores of IBS-quality of life ( IBS-QOL ) rating scale and IBS-symptom severity scale ( IBS-SSS ) rating scale .


The secondary outcome measures include the improvement of symptom scores , and the duration of abdominal pain and diarrhea .


According to TCM theory , SQTX Granule has a regulating effect on abdominal pain , diarrhea and the syndrome of liver-spleen disharmony , which is similar to the symptoms of IBS-D .


This study will provide objective evidence to evaluate the efficiency and safety of SQTX Granule in IBS-D treatment .


ChiCTR-TRC-14004241 .


Date of registration : 9 February 2014 .


To explore changes of B and T lymphocyte attenuator ( BTLA ) , superoxide dismutase ( SOD ) , catalase ( CAT ) , total antioxidant capacity ( TAOC ) , reactive oxygen species ( ROS ) , reactive nitrogen species ( RNS ) , malondialdehyde ( MDA ) in ankylosing spondylitis ( AS ) patients , and the effect of Xinfeng Capsule ( XFC ) on them .


Totally 120 AS patients were assigned to two groups according to random digit table method , the XFC group ( 3 XFC pills each time , 3 times a day ) and the SASP group ( 4 SASP tablets each time , twice a day ) , 60 in each group .


All patients were treated for 3 months .


Another 60 healthy subjects were recruited as a healthy control group .


The expression frequency and activation levels of BTLA were detected using flow cytometry .


Serum oxidative stress indices ( such as SOD and CAT , TAOC , ROS , RNS , MDA ) and contents of cytokines [ tumor necrosis factor ( TNF - ) , IL-1 , IL-4 , and IL-10 ] were detected using enzyme-linked immunoassay ( ELISA ) .


Erythrocyte sedimentation rate ( ESR ) was detected using Westergren method .


High-sensitivity C-reactive protein ( Hs-CRP ) was detected using HITACHI 7060 type automatic biochemical analyzer .


Clinical efficacies of ASAS 20 and BASDAI50 were assessed using VAS .


Correlation analysis between scoring for quality of life and BTLA expression frequency was performed .


( 1 ) Clinical efficacies of ASAS 20 and BASDAI50 were significantly better in the XFC group than in the SASP group ( P < 0.01 ) .


( 2 ) Compared with the healthy control group , BTLA expressions in the peripheral blood of AS patients decreased significantly ( P < 0.05 ) ; SOD , CAT , and TAOC values significantly decreased ( P < 0.01 , P < 0.05 ) ; ROS , RNS , and MDA values significantly increased ( P < 0.01 , P < 0.05 ) ; TNF - , IL-1 , ESR , and Hs-CRP values significantly increased ( P < 0.01 ) ; IL-4 and IL-10 values decreased significantly ( P < 0.01 , P < 0.05 ) .


( 3 ) Compared with pre-treatment in the same group , BTLA/CD19 + B , BTLA/CD24 + B , SOD , TAOC , IL-4 , SF-36 [ physical functioning ( PF ) , social functioning ( SF ) , role limitation due to physical problems ( RP ) , role limitation due to emotional problems ( RE ) , body pain ( BP ) , mental health ( MH ) , vitality ( VT ) , general health ( GH ) ] were significantly elevated ; ROS , MDA , TNF - , ESR , Hs - CRP , VAS , BASDAI and BASFI , BAS-G were significantly lower in the peripheral blood of the two groups after treatment ( P < 0.01 , P < 0.05 ) .


Better effect was shown in the XFC group in elevating BTLA/CD19 + B , BTLA/CD24 + B , SOD , TAOC , IL-10 , BP , MH , VT , and SF ; and lowering ROS , IL-1 , MDA , TNF - , ESR , Hs-CRP , VAS , BASDAI , BASFI , and BAS-G ( P < 0.01 , P < 0.05 ) .


( 4 ) Pearson correlation analysis showed , BTLA/CD19 + B expression of the peripheral blood was positively correlated with SOD , CAT , TAOC , IL-4 , IL-10 , GH , RP , BP , and SF ( r = 0.431 , 0.325 , 0.318 , 0.316 , 0.348 , 0.314 , 0.358 , 0.318 , 0.326 , respectively , P < 0.05 , P < 0.01 ) , while it was negative correlated with ROS , MDA , TNF - , IL-1 , ESR , VAS , and BASDAI ( r = -0.342 , -0.368 , -0.334 , -0.354 , -0.324 , -0.372 , -0.342 , respectively , P < 0.05 , P < 0.01 ) .


BTLA/CD24 B expression of the peripheral blood was positively correlated with SOD , TAOC , IL-4 , IL-10 , GH , RP , BP , SF , RE , MH , VT ( r = 0.358 , 0.352 , 0.372 , 0.436 , 0.435 , 0.326 , 0.352 , 0.345 , 0.326 , 0.343 , 0.332 , respectively , P < 0.05 , P < 0.01 ) , while it was negative correlated with ROS , RNS , MDA , ESR , Hs-CRP , VAS , BASDAI , and BASFI ( r = -0.447 , -0.336 , -0.405 , -0.395 , -0.358 , -0.436 , -0.338 , -0.425 , respectively , P < 0.05 , P < 0.01 ) .


XFC could improve BTLA expression in the peripheral blood of AS patients , negatively regulate activation and proliferation of B cells , and reduce abnormal immune responses and oxidative stress injury , thereby effectively alleviating joint stiffness and pain .


To evaluate the impacts on the short-term efficacy and the long-term prevention of recurrence of allergic rhinitis treated with the triple-strong stimulation at Dazhui ( GV 14 ) so as to provide the convenient and long-term effective therapy of acupuncture and moxibustion for allergic rhinitis .


One hundred and twenty cases of allergic rhinitis were randomized into an acupuncture group , an acupuncture + medication group and a triple-strong stimulation group , 40 cases in each one .


In the acupuncture group , acupuncture was applied at Dazhui ( GV 14 ) , Fengchi ( GB 20 ) , Baihui ( GV 20 ) , Yintang ( GV 29 ) and the others , stimulating with reinforcing manipulation for the deficiency and reducing manipulation for the excess , once every day .


In the acupuncture + medication group , on the basis of acupuncture therapy , claritin ( loratadine tablets ) was supplemented for oral administration , 10 mg , once every two days , continuously for 30 days .


In the triple-strong stimulation group , on the basis of acupuncture therapy , the strong needling , strong cupping and strong moxibustion were applied at Dazhui ( GV 14 ) .


This combined therapy was given once every day in the first 3 days and once every two days afterwards .


The 10 day treatment made one session , at the interval of 3 days between the sessions and totally 3 sessions were required in the three groups .


Separately , before treatment , after treatment and in 6 months after treatment , the changes of symptom and physical sign score and value of single item symptom including nasal itching , nasal blockage , sneezing and rhinorrhea were observed in the patients of the three groups .


And the long-term clinical efficacy was compared among the three groups .


The symptom and physical sign score and the value of single item symptom were all reduced in the three groups after treatment and in 6 months after treatment ( P < 0.001 , P < 0.01 , P < 0.05 ) .


The results in the triple-strong stimulation group were superior to the other two groups ( all P < 0.05 ) .


In the triple-strong stimulation group , the total effective rate was 92.5 % ( 36/40 ) in the follow-up of 6 months after treatment , which was better than 60.5 % ( 23/38 ) in the acupuncture group and 69.2 % ( 27/39 ) in the acupuncture + medication group ( both P < 0.01 ) .


The combined therapy of acupuncture and the triple-strong stimulation at Dazhui ( GV 14 ) achieves the reliable and effective result in the clinical treatment of allergic rhinitis and displays the good role on the prevention from long-term recurrence .


To analyse change in selected bone markers in peri-implant sulcus fluid ( PISF ) sampled before treatment and after 12 months and test correlation with change in disease progression .


Peri-implant sulcus fluid was sampled from 32 patients in a randomized , clinical study comparing peri-implant defect re-construction with or without porous titanium granules .


Matrix metalloproteinase 8 levels were measured using the Quantikine Human Total MMP-8 ( DMP800 ) ELISA .


Multianalyte profiling of the level of bone markers [ interleukin-6 , osteprotegerin ( OPG ) , osteocalcin , leptin , osteopontin , parathyroid hormone , tumour necrosis factor - , adiponectin and insulin ] was performed by Luminex using Human Bone Panel IB .


Changes in bone marker levels were compared and correlation with clinical findings was tested .


No differences in clinical parameter or bone marker levels between test and control group were found .


When comparing bone marker levels irrespective of treatment allocation between baseline and 12 months , a significant reduction in total protein , matrix metalloproteinase -8 , interleukin-6 , OPG , leptin and adiponectin were demonstrated .


Positive correlations were found between the reduction in interleukin-6 ( r = 0.43 ) , insulin ( r = 0.38 ) and matrix metalloproteinase-8 ( r = 0.47 ) concentration , and probing pocket depth reduction .


Peri-implantitis surgical treatment induced some reduction of the studied bone markers .


Conclusive evidence for correlation between change in bone marker concentrations with disease resolution was not found .


Screening of natural compounds for the development of anti-acne therapeutic agents has been steadily required considering various side effects of acne medications .


However , previous studies have mainly focused on experimental tests without clinical trials and histopathological analysis .


To compare the clinical efficacy , safety and histopathological changes between Lactobacillus-fermented Chamaecyparis obtusa ( LFCO ) and existing tea tree oil ( TTO ) .


A total of 34 patients were instructed to apply 5 % LFCO to the involved areas of a randomly allocated side and 5 % TTO extract to the other side for 8 weeks in a double-blind split-face clinical trial .


After 8 weeks , inflammatory acne lesions were reduced by 65.3 % on the LFCO side and by 38.2 % on the TTO side .


LFCO was also superior to TTO in the onset time of efficacy ( p < 0.05 ) .


The LFCO side further demonstrated improvement for non-inflammatory lesions ( 52.6 % , p < 0.05 ) , decreased size of sebaceous glands and sebum output reductions .


Patients ' subjective satisfaction was also higher without severe adverse reactions .


Protein expressions of nuclear factor B decreased earlier on the LFCO side , and those of interleukin-1 ( IL-1 ) , IL-8 , insulin-like growth factor 1 receptor and sterol regulatory element-binding protein 1 decreased subsequently .


Ultra-performance liquid chromatography/high-resolution mass spectrometry further demonstrated that the contents of dihydroxybenzoic acid , taxifolin and quercetin were increased in LFCO after fermentation .


LFCO treatment was rapid and effective for treating acne lesions compared to TTO .


Histopathological findings correlated well with the clinical acne grade and treatment response .


This novel natural compound appears to be effective and safe for acne treatment .


This study aims to investigate the possible differences in skin temperature and blood perfusion changes between single and triple moxibustion .


Thirty healthy volunteers were randomly divided into two groups : a triple moxibustion group ( n = 15 ) received indirect moxibustion on CV12 for 30min and a single moxibustion group ( n = 15 ) for 10min .


After 10min of bed rest , skin temperature and blood perfusion were measured by digital infrared thermal imaging and laser Doppler perfusion imaging eight times in total , pre-moxibustion and 0 , 5 , 10 , 15 , 20 , 25 and 30min post moxibustion .


The changes in the skin temperature and blood perfusion in an area 5cm in diameter around CV12 at 0min post treatment compared to baseline was the main outcome measurement .


The difference of changes in skin temperature and blood perfusion on CV12 between the two groups remained statistically significant for 30min in an area 5cm in diameter around CV12 and for 25min in a 15-cm-diameter area .


No adverse events were reported .


Triple moxibustion with large , indirect moxa appeared to induce greater increases in skin temperature and blood perfusion than single moxibustion .


Published correlations between histological abnormalities and right ventricular ( RV ) function , as evaluated by speckle tracking echocardiography ( STE ) , are scarce in patients with tetralogy of Fallot ( TOF ) .


The purpose of the study is to assess age-associated differences in the effect of RV myocardial remodeling on ventricular function in patients with TOF .


Operatively resected crista supraventricularis muscle from 30 patients ( median age 12months ) undergoing intracardiac repair of TOF were studied by light microscopy .


The patients were divided into younger ( age at surgery 12months ) and older ( age at surgery > 12months ) subgroups .


The RV global longitudinal peak systolic strain ( GLS ) , strain rate ( GLSRs ) and early diastolic strain rate ( GLSRe ) were measured by two-dimensional STE before and 6months after repair .


The histopathological data revealed hypertrophy of the cardiomyocytes , a thickened endocardium , and increased interstitial and perivascular collagen in RV , which were associated with older age at the time of repair .


The RV global systolic and diastolic functions in patients with repaired TOF were increased compared with the preoperative values .


The RV cardiomyocyte diameter and collagen volume fraction ( CVF ) correlated with the preoperative GLS , GLSRs and GLSRe , respectively , in the younger patients ( r1 = -0.566 , P1 = 0.018 ; r2 = -0.493 , P2 = 0.004 ; r3 = -0.504 , P3 = 0.039 ) .


The RV cardiomyocyte diameter and CVF correlated with preoperative GLS , GLSRs and GLSRe , respectively , in the older patients ( r1 = -737 , P1 = 0.004 ; r2 = -0.588 , P2 = 0.035 ; r3 = -0.812 , P3 = 0.001 ) .


The correlation of the RV cardiomyocyte diameter with the postoperative GLS and GLSRe ( r1 = -665 , P1 = 0.036 ; r2 = -0.787 , P2 = 0.007 ) and the CVF with the postoperative GLSRs and GLSRe ( r1 = -762 , P1 = 0.002 ; r2 = -0.713 , P2 = 0.004 ) were identified only in the older patients .


Multivariate analysis indicated that the age at repair was an independent predictor of postoperative GLSRs and GLSRe in all of the patients ( = -0.449 , P = 0.041 ; = -0.607 , P = 0.004 ) .


The effect of RV myocardial remodeling on preoperative RV function was more pronounced in the older patients with TOF than in the younger ones .


Preoperative myocardial remodeling affected the postoperative RV function in the older but not in the younger patients .


The age at the time of surgical repair was the independent determinant of the postoperative RV myocardial function .


While meta-analyses and clinical trials show improved survival in advanced NSCLC treated with platinum-containing chemotherapy , there are few data concerning front-line platinum-free ifosfamide-based regimens .


We aimed to compare cisplatin-based chemotherapy to ifosfamide-gemcitabine ( IG ) with pre-defined second-line docetaxel .


693 Untreated advanced inoperable NSCLC cases were randomised to either GIP ( gemcitabine , ifosfamide , cisplatin ) , DP ( docetaxel , cisplatin ) or IG .


Primary outcome was overall survival .


Median age of the patients was 58 years with a predominance of males ( 75 % ) , adenocarcinoma ( 56 % ) , Karnofsky PS 80-100 ( 77 % ) and stage-IV disease ( 81 % ) .


Median survival times were 8.7 , 8.8 and 8.3 months for IG , GIP and DP ( p = 0.79 ) .


GIP presented with ( p < 0.05 ) greater neutropenia , thrombopenia , vomiting , while greater cardiotoxicity , diarrhea , peripheral neuropathy were observed for DP and encephalopathy for IG .


In advanced NSCLC , cisplatin-based CT is not superior to a platinum-free regimen ( ifosfamide-gemcitabine ) with a favourable toxicity profile .


The aim of this study was to compare the antiinflammatory effect and ocular surface toxicity of topical nonpreserved methylprednisolone sodium succinate 1 % and preserved prednisolone acetate suspension 1 % for the management of acute anterior uveitis ( AAU ) .


In this prospective , randomized , investigator-masked , comparative clinical trial , patients with mild-to-moderate noninfectious AAU were assigned randomly to receive either hourly nonpreserved methylprednisolone 1 % ( group A ) or preserved prednisolone 1 % ( group B ) eye drops followed by a 2-week tapering regimen .


Anterior chamber cells and flare were clinically evaluated for the objective comparison of the antiinflammatory effect .


The main outcome measure was the percentage of patients with a resolution of inflammation ( anterior chamber cells < 1 + ) on day 14 .


Ocular surface toxicity was assessed by means of the corneal fluorescein staining score , tear breakup time , Schirmer I test , and questionnaire-based grading of ocular discomfort parameters .


Seventy-two eyes of 68 patients were studied , of which 38 eyes were enrolled in group A and 34 eyes were enrolled in group B. On day 14 , 76.3 % of the patients in group A had resolution of inflammation compared with 70.6 % of the patients in group B , proving noninferiority ( = 0.303 , P = 0.582 ) .


The mean anterior chamber cell grade reduction for patients in group A was similar to that in group B ( 2.52 vs. 2.86 , respectively ; P = 0.92 ) .


Group A patients showed significantly lower corneal fluorescein staining scores ( P < 0.001 ) and reported milder subjective ocular discomfort ( 0.55 vs. 1.43 , P = 0.01 ) as compared with group B.


Both preparations demonstrated equal antiinflammatory effects for the treatment of AAU .


Nonpreserved methylprednisolone eye drops exhibited a significantly lower ocular surface toxicity profile and milder subjective discomfort when compared with that exhibited by preserved prednisolone .


To determine whether 30 head-down tilt ( HDT ) used for secretion clearance is safe for acute trauma patients .


There are concerns that HDT may lead to cardiac irregularities in intubated patients in the ICU .


Eleven mechanically ventilated trauma patients ( 25-42 yrs ) without cardiovascular problems received two interventions , one supine HDT for 10 min and a control in the horizontal supine position ( HS ) , in a crossover design .


Compared to baseline there were statistically significant ( p < 0.05 ) increases in SBP ( 6.3 mm Hg ; 95 % CI 2.5 , 12.7 ) and CVP ( 7.3 cm H2O ; 5.7 , 10.0 ) during 10 min HDT although these were not of clinical concern .


Heart rate and oxygen saturation were unchanged .


No episodes of arrhythmia or hypoxemia were observed .


All values returned close to baseline during 10 min horizontal recovery .


There were no significant changes during the control HS intervention .


30 HDT entails minimal risk for trauma patients who have no underlying cardiovascular disease .


To examine whether or not the combination of diclofenac suppository with peri-prostatic nerve block ( PPNB ) was effective in reducing the degree of pain experienced during transrectal ultrasound ( TRUS ) - guided prostate biopsy in a randomised single-blind placebo-controlled trial .


In all , 96 patients having a planned TRUS-guided prostate biopsy were randomised into one of the following arms on a 1:1 basis : 10mL 1 % lignocaine PPNB and placebo suppository ( control ) or 10mL 1 % lignocaine PPNB and 100mg diclofenac suppository ( treatment ) .


Pain scores were recorded using the Numerical Rating Scale for pain ( 0-10 ) at the following time-points : ( i ) introduction of probe , ( ii ) during biopsy , ( iii ) 1h after biopsy , ( iv ) later that evening ( 6h after biopsy ) and ( v ) 1 day after biopsy .


Patients were asked about their preferred method for pain control if a repeat TRUS-guided prostate biopsy was required : local anaesthetic ( LA ) again or intravenous sedation .


There were no significant differences in age ( P = 0.653 ) or PSA level ( P = 0.584 ) between either study arm .


The differences in pain scores between the control and treatment groups were not significant at Time 1 ( probe insertion ; P = 0.299 ) , Time 2 ( biopsy ; P = 0.983 ) , Time 4 ( evening after ; P = 0.231 ) and Time 5 ( 1 day after biopsy ; P = 0.384 ) .


At Time 3 ( 1h after biopsy ) , the control pain scale scores were statistically significantly higher than the treatment pain scale scores ( P = 0.044 ) .


There was no difference between treatment ( 87 % ) and control ( 80 % ) groups as to whether they would prefer to repeat the biopsy under LA ( P = 0.373 ) .


The use of a diclofenac suppository with PPNB did not show any clinically meaningful effect in decreasing pain or improving tolerability of TRUS-guided prostate biopsy and is not recommended .


PPNB TRUS-guided biopsy is extremely well tolerated , with > 80 % of patients electing for subsequent LA biopsy if required .


In the Determining the Efficacy and Tolerability of cholesteryl ester transfer protein ( CETP ) INhibition with AnacEtrapib ( DEFINE ) trial , anacetrapib added to statin produced robust low-density lipoprotein cholesterol ( LDL-C ) - lowering and high-density lipoprotein cholesterol ( HDL-C ) - raising vs placebo in patients with coronary heart disease ( CHD ) .


Predictors of the degree of LDL-C and HDL-C responses to anacetrapib , however , are poorly understood .


Lipid effects of anacetrapib in patient subgroups within the DEFINE trial ( clinicaltrials.gov : NCT00685776 ) are reported .


The percent of placebo-corrected changes from baseline for LDL-C ( estimated by Friedewald calculation [ Fc-LDL-C ] ) and HDL-C after 24weeks of anacetrapib 100mg/day were compared among patients by age , gender , race , diabetes status , type of concomitant statin with or without other lipid therapies , and baseline HDL-C , Fc-LDL-C , and triglyceride ( TG ) levels .


Percent decreases in Fc-LDL-C and increases in HDL-C with anacetrapib were similar ( magnitude of difference generally < 1/5 of the overall treatment effect ) across subgroups by age , gender , diabetes status , lipid-modifying regimen , and baseline Fc-LDL-C , HDL-C , or TG .


On the other hand , anacetrapib effects on Fc-LDL-C ( -24 % vs -41 % ) and HDL-C ( +75 % vs +139 % ) appeared to be less in black vs white patients , respectively .


Effects of anacetrapib on Fc-LDL-C and HDL-C were generally comparable across subgroups , including being relatively independent of baseline Fc-LDL-C , HDL-C , or TG levels .


The clinical impact of the lipid-modifying effects of anacetrapib is being evaluated in the cardiovascular disease outcomes trial , Randomized EValuation of the Effects of Anacetrapib though Lipid-modification ( REVEAL ) .


Three months of a once-weekly combination of rifapentine and isoniazid for treatment of latent tuberculosis infection is safe and effective for persons 12 years or older .


Published data for children are limited .


To compare treatment safety and assess noninferiority treatment effectiveness of combination therapy with rifapentine and isoniazid vs 9 months of isoniazid treatment for latent tuberculosis infection in children .


A pediatric cohort nested within a randomized , open-label clinical trial conducted from June 11 , 2001 , through December 17 , 2010 , with follow-up through September 5 , 2013 , in 29 study sites in the United States , Canada , Brazil , Hong Kong ( China ) , and Spain .


Participants were children ( aged 2-17 years ) who were eligible for treatment of latent tuberculosis infection .


Twelve once-weekly doses of the combination drugs , given with supervision by a health care professional , for 3 months vs 270 daily doses of isoniazid , without supervision by a health care professional , for 9 months .


We compared rates of treatment discontinuation because of adverse events ( AEs ) , toxicity grades 1 to 4 , and deaths from any cause .


The equivalence margin for the comparison of AE-related discontinuation rates was 5 % .


Tuberculosis disease diagnosed within 33 months of enrollment was the main end point for testing effectiveness .


The noninferiority margin was 0.75 % .


Of 1058 children enrolled , 905 were eligible for evaluation of effectiveness .


Of 471 in the combination-therapy group , 415 ( 88.1 % ) completed treatment vs 351 of 434 ( 80.9 % ) in the isoniazid-only group ( P = .003 ) .


The 95 % CI for the difference in rates of discontinuation attributed to an AE was -2.6 to 0.1 , which was within the equivalence range .


In the safety population , 3 of 539 participants ( 0.6 % ) who took the combination drugs had a grade 3 AE vs 1 of 493 ( 0.2 % ) who received isoniazid only .


Neither arm had any hepatotoxicity , grade 4 AEs , or treatment-attributed death .


None of the 471 in the combination-therapy group developed tuberculosis vs 3 of 434 ( cumulative rate , 0.74 % ) in the isoniazid-only group , for a difference of -0.74 % and an upper bound of the 95 % CI of the difference of +0.32 % , which met the noninferiority criterion .


Treatment with the combination of rifapentine and isoniazid was as effective as isoniazid-only treatment for the prevention of tuberculosis in children aged 2 to 17 years .


The combination-therapy group had a higher treatment completion rate than did the isoniazid-only group and was safe .


clinicaltrials.gov Identifier : NCT00023452 .


To evaluate the safety and efficacy of daclatasvir , an HCV NS5A inhibitor with pangenotypic activity , administered with peginterferon-alfa-2a / ribavirin .


In this Phase 2b double-blind , placebo-controlled study , treatment-naive adults with HCV genotype 1 ( N = 365 ) or 4 ( N = 30 ) infection were randomly assigned ( 2:2:1 ) to daclatasvir 20mg or 60mg , or placebo once daily plus weekly peginterferon-alfa-2a and twice-daily ribavirin .


Daclatasvir recipients achieving protocol-defined response ( PDR ; HCV-RNA < lower limit of quantitation at Week 4 and undetectable at Week 10 ) were rerandomised at Week 12 to continue daclatasvir/peginterferon-alfa -2 a/ribavirin for 24weeks total duration or to placebo/peginterferon-alfa -2 a/ribavirin for another 12weeks .


Patients without PDR and placebo patients continued peginterferon-alfa/ribavirin through Week 48 .


Primary efficacy endpoints were undetectable HCV-RNA at Weeks 4 and 12 ( extended rapid virologic response , eRVR ) and at 24weeks post-treatment ( sustained virologic response , SVR24 ) among genotype 1-infected patients .


Overall , eRVR was achieved by 54.4 % ( 80/147 ) of genotype 1-infected patients receiving daclatasvir 20mg , 54.1 % ( 79/146 ) receiving 60mg versus 13.9 % ( 10/72 ) receiving placebo .


SVR24 was achieved among 87 ( 59.2 % ) , 87 ( 59.6 % ) , and 27 ( 37.5 % ) patients in these groups , respectively .


Higher proportions of genotype 4-infected patients receiving daclatasvir 20mg ( 66.7 % ; 8/12 ) or 60mg ( 100.0 % ; 12/12 ) achieved SVR24 versus placebo ( 50.0 % ; 3/6 ) .


A majority of daclatasvir-treated patients achieved PDR and experienced less virologic failure and higher SVR24 rates with a shortened 24-week treatment duration .


Adverse events occurred with similar frequency across all treatment groups .


The combination of daclatasvir/peginterferon-alfa/ribavirin was generally well tolerated and achieved higher SVR24 rates compared with placebo/peginterferon-alfa/ribavirin among patients infected with HCV genotype 1 or 4 .


NCT01125189 .


Examine whether cognitive behavioral therapy for insomnia ( CBT-I ) improves sleep in posttraumatic stress disorder ( PTSD ) as well as nightmares , nonsleep PTSD symptoms , depression symptoms , and psychosocial functioning .


RANDOMIZED CONTROLLED TRIAL WITH TWO ARMS : CBT-I and monitor-only waitlist control .


Department of Veterans Affairs ( VA ) Medical Center .


Forty-five adults ( 31 females : [ mean age 37 y ( 22-59 y ) ] with PTSD meeting research diagnostic criteria for insomnia , randomly assigned to CBT-I ( n = 29 ; 22 females ) or monitor-only waitlist control ( n = 16 ; nine females ) .


Eight-session weekly individual CBT-I delivered by a licensed clinical psychologist or a board-certified psychiatrist .


Measures included continuous monitoring of sleep with diary and actigraphy ; prepolysomnography and postpolysomnography and Clinician-Administered PTSD Scale ( CAPS ) ; and pre , mid , and post self-report questionnaires , with follow-up of CBT-I participants 6 mo later .


CBT-I was superior to the waitlist control condition in all sleep diary outcomes and in polysomnography-measured total sleep time .


Compared to waitlist participants , CBT-I participants reported improved subjective sleep ( 41 % full remission versus 0 % ) , disruptive nocturnal behaviors ( based on the Pittsburgh Sleep Quality Index-Addendum ) , and overall work and interpersonal functioning .


These effects were maintained at 6-mo follow-up .


Both CBT-I and waitlist control participants reported reductions in PTSD symptoms and CAPS-measured nightmares .


Cognitive behavioral therapy for insomnia ( CBT-I ) improved sleep in individuals with posttraumatic stress disorder , with durable gains at 6 mo. .


Overall psychosocial functioning improved following CBT-I .


The initial evidence regarding CBT-I and nightmares is promising but further research is needed .


Results suggest that a comprehensive approach to treatment of posttraumatic stress disorder should include behavioral sleep medicine .


TRIAL NAME : Cognitive Behavioral Treatment Of Insomnia In Posttraumatic Stress Disorder .


URL : http://clinicaltrials.gov/ct2/show/NCT00881647 .


NCT00881647 .


Irritable bowel syndrome ( IBS ) is a common disorder in Iran with challenging treatment .


Although trials have suggested that probiotics alleviate the complaints of patients with minimal side effects , they have not been investigated in Iranian adults .


In a randomized double-blind study , 108 eligible IBS patients ( Rome III Criteria ) aged 20 - 70 years who referred consecutively to a clinical center in Tehran with abdominal bloating from 2010 to 2012 received a combination probiotics or placebo twice daily for 4 weeks .


The objective was to evaluate the efficacy and safety of a multi-strain probiotics combination .


One week prior to and throughout the treatment , the participants recorded their abdominal symptoms on a daily basis , using visual analogue scale and reported satisfactory relief of general symptoms at the end of each week .


Adverse events were evaluated by self-reporting and physical examination .


Continuous variables were analyzed by independent t-test and chi-square was used for binomials .


The baseline characteristics were balanced ( 60 % female , mean age 36.7 11.5 ) .


A total of 97 ( 51 intervention , 46 control ) completed the treatment .


Intention to treat analysis was done on 108 allocated subjects .


85 % of the probiotic group reported satisfactory relief of general symptoms compared with 47 % in the control group ( P < 0.01 ) .


A reduction in abdominal bloating and pain with probiotic was superior to placebo [ -13.0 vs. -3.7 ( P < 0.01 ) , -8.2 vs. -2.1 ( P = 0.02 ) , respectively ] .


No severe adverse drug reaction was seen in either group .


A 4-week period of treatment with the combination probiotics twice daily was safe , well tolerated , and effective in our patients .


Further investigation is recommended for other subgroups of IBS .


Trial Registration : IRCT.ir IRCT2012071010230N1 .


Laparoscopic resection and a multimodal approach known as an enhanced recovery program ( ERP ) have been major changes in colorectal perioperative care that have improved clinical outcomes for colorectal cancer resection .


EnROL ( Enhanced Recovery Open Versus Laparoscopic ) is a multicenter randomized controlled trial examining whether the benefits of laparoscopy still exist when open surgery is optimized within an ERP .


Adults with colorectal cancer suitable for elective resection were randomly assigned at a ratio of 1:1 to laparoscopic or open surgery within an ERP , stratified by center , cancer site ( colon v rectum ) , and age group ( < 66 v 66-75 v > 75 years ) using minimization .


The primary outcome was physical fatigue at 1 month postsurgery .


Secondary outcomes included hospital stay , complications , other patient-reported outcomes ( PROs ) , and physical function .


Patients and outcome assessors were blinded until 7 days postsurgery or discharge if earlier .


Central independent and blinded pathologic assessment of surgical quality was undertaken .


A total of 204 patients ( laparoscopy , n = 103 ; open surgery , n = 101 ) were recruited from 12 UK centers from July 2008 to April 2012 .


One-month physical fatigue scores were similar in both groups ( mean : laparoscopy , 12.28 ; 95 % CI , 11.37 to 13.19 v open surgery , 12.05 ; 95 % CI , 11.14 to 12.96 ; adjusted mean difference , -0.23 ; 95 % CI , -1.52 to 1.07 ) .


Median total hospital stay was significantly shorter after laparoscopic surgery ( median : laparoscopy , 5 ; interquartile range [ IQR ] , 4 to 9 v open surgery , 7 ; IQR , 5 to 11 days ; P = .033 ) .


There were no differences in other secondary outcomes or in specimen quality after central pathologic review .


In patients treated by experienced surgeons within an ERP , physical fatigue and other PROs were similar in both groups , but laparoscopic surgery significantly reduced length of hospital stay .


This 12-week study assessed the efficacy and tolerability of imeglimin as add-on therapy to the dipeptidyl peptidase-4 inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled with sitagliptin monotherapy .


In a multicenter , randomized , double-blind , placebo-controlled , parallel-group study , imeglimin ( 1,500 mg b.i.d. ) or placebo was added to sitagliptin ( 100 mg q.d. ) over 12 weeks in 170 patients with type 2 diabetes ( mean age 56.8 years ; BMI 32.2 kg/m ( 2 ) ) that was inadequately controlled with sitagliptin alone ( A1C 7.5 % ) during a 12-week run-in period .


The primary efficacy end point was the change in A1C from baseline versus placebo ; secondary end points included corresponding changes in fasting plasma glucose ( FPG ) levels , stratification by baseline A1C , and percentage of A1C responders .


Imeglimin reduced A1C levels ( least-squares mean difference ) from baseline ( 8.5 % ) by 0.60 % compared with an increase of 0.12 % with placebo ( between-group difference 0.72 % , P < 0.001 ) .


The corresponding changes in FPG were -0.93 mmol/L with imeglimin vs. -0.11 mmol/L with placebo ( P = 0.014 ) .


With imeglimin , the A1C level decreased by 0.5 % in 54.3 % of subjects vs. 21.6 % with placebo ( P < 0.001 ) , and 19.8 % of subjects receiving imeglimin achieved a decrease in A1C level of 7 % compared with subjects receiving placebo ( 1.1 % ) ( P = 0.004 ) .


Imeglimin was generally well tolerated , with a safety profile comparable to placebo and no related treatment-emergent adverse events .


Imeglimin demonstrated incremental efficacy benefits as add-on therapy to sitagliptin , with comparable tolerability to placebo , highlighting the potential for imeglimin to complement other oral antihyperglycemic therapies .


There is a need for effective population-based physical activity interventions .


The internet provides a good platform to deliver physical activity interventions and reach large numbers of people at low cost .


Personalised advice in web-based physical activity interventions has shown to improve engagement and behavioural outcomes , though it is unclear if the effectiveness of such interventions may further be improved when providing brief video-based coaching sessions with participants .


The purpose of this study is to determine the effectiveness , in terms of engagement , retention , satisfaction and physical activity changes , of a web-based and computer-tailored physical activity intervention with and without the addition of a brief video-based coaching session in comparison to a control group .


Participants will be randomly assigned to one of three groups ( tailoring + online video-coaching , tailoring-only and wait-list control ) .


The tailoring + video-coaching participants will receive a computer-tailored web-based physical activity intervention ( ` My Activity Coach ' ) with brief coaching sessions with a physical activity expert over an online video calling program ( e.g. Skype ) .


The tailoring-only participants will receive the intervention but not the counselling sessions .


The primary time point 's for outcome assessment will be immediately post intervention ( week 9 ) .


The secondary time points will be at 6 and 12months post-baseline .


The primary outcome , physical activity change , will be assessed via the Active Australia Questionnaire ( AAQ ) .


Secondary outcome measures include correlates of physical activity ( mediators and moderators ) , quality of life ( measured via the SF-12v2 ) , participant satisfaction , engagement ( using web-site user statistics ) and study retention .


Study findings will inform researchers and practitioners about the feasibility and effectiveness of brief online video-coaching sessions in combination with computer-tailored physical activity advice .


This may increase intervention effectiveness at an acceptable cost and will inform the development of future web-based physical activity interventions .


ACTRN12614000339651Date : 31/03/2014 .


Asthma exacerbations lead to frequent emergency visits and hospitalizations , and are associated with high morbidity and occasionally mortality .


New therapeutic strategies are needed .


We sought to investigate whether the addition of high-dose inhaled budesonide to standard therapy would shorten the length of stay ( LOS ) in hospital of children admitted for asthma exacerbations .


The study was designed as a single-center , double-blind , placebo-controlled and parallel-group trial .


Children aged 7-72 months and admitted with an asthma exacerbation clinical asthma score ( CAS ) of between 3 and 9 were allocated to either the budesonide ( n = 50 ) or the placebo ( n = 50 ) group .


Hospital LOS was compared between children who received 2 mg/day of budesonide versus placebo in addition to standard management of asthma exacerbation involving oxygen inhalation and 2-agonist , anticholinergic and oral corticosteroid therapy .


All patients were assessed every 4 h. Children with a CAS < 3 , a peripheral oxygen saturation > 95 % and normal pulmonary function , and those with a symptom-free period of at least 4 h after salbutamol treatment were discharged .


Total hospital LOS was significantly shorter in the budesonide group than in the placebo group ( median : 44 vs. 80 h , respectively ; p = 0.01 ) .


When compared with placebo , the number of inpatients was significantly less in the budesonide group at all the assessed end points ( Kaplan-Meier ; p = 0.022 ) .


Additionally , nebulized budesonide was found to reduce the overall cost of treatment .


We demonstrated that , for children hospitalized for asthma exacerbations , an additional 2 mg/day of nebulized budesonide significantly reduced hospital LOS as well as the overall cost of treatment .


Barrett esophagus containing low-grade dysplasia is associated with an increased risk of developing esophageal adenocarcinoma , a cancer with a rapidly increasing incidence in the western world .


To investigate whether endoscopic radiofrequency ablation could decrease the rate of neoplastic progression .


Multicenter randomized clinical trial that enrolled 136 patients with a confirmed diagnosis of Barrett esophagus containing low-grade dysplasia at 9 European sites between June 2007 and June 2011 .


Patient follow-up ended May 2013 .


Eligible patients were randomly assigned in a 1:1 ratio to either endoscopic treatment with radiofrequency ablation ( ablation ) or endoscopic surveillance ( control ) .


Ablation was performed with the balloon device for circumferential ablation of the esophagus or the focal device for targeted ablation , with a maximum of 5 sessions allowed .


The primary outcome was neoplastic progression to high-grade dysplasia or adenocarcinoma during a 3-year follow-up since randomization .


Secondary outcomes were complete eradication of dysplasia and intestinal metaplasia and adverse events .


Sixty-eight patients were randomized to receive ablation and 68 to receive control .


Ablation reduced the risk of progression to high-grade dysplasia or adenocarcinoma by 25.0 % ( 1.5 % for ablation vs 26.5 % for control ; 95 % CI , 14.1 % -35.9 % ; P < .001 ) and the risk of progression to adenocarcinoma by 7.4 % ( 1.5 % for ablation vs 8.8 % for control ; 95 % CI , 0 % -14.7 % ; P = .03 ) .


Among patients in the ablation group , complete eradication occurred in 92.6 % for dysplasia and 88.2 % for intestinal metaplasia compared with 27.9 % for dysplasia and 0.0 % for intestinal metaplasia among patients in the control group ( P < .001 ) .


Treatment-related adverse events occurred in 19.1 % of patients receiving ablation ( P < .001 ) .


The most common adverse event was stricture , occurring in 8 patients receiving ablation ( 11.8 % ) , all resolved by endoscopic dilation ( median , 1 session ) .


The data and safety monitoring board recommended early termination of the trial due to superiority of ablation for the primary outcome and the potential for patient safety issues if the trial continued .


In this randomized trial of patients with Barrett esophagus and a confirmed diagnosis of low-grade dysplasia , radiofrequency ablation resulted in a reduced risk of neoplastic progression over 3 years of follow-up .


trialregister.nl Identifier : NTR1198 .


The aim of this study was to compare the efficiency of dopamine agonist , Cabergoline , in decreasing the size of endometrioma , with that of luteinizing hormone releasing hormone ( LHRH ) agonist , triptorelin acetate .


This was a prospective , randomized study .


The setting was in two private medical centers in the UAE , from January 2011 to February 2012 .


One hundred and forty patients complaining of endometrioma , and fulfilling the eligibility criteria , were chosen and divided into two groups as follows : Group I comprised 71 patients ; all of them received Cabergoline tablets , 0.5 mg tablets , twice per week for 12weeks .


Group II comprised 69 patients ; all of them received LHRH agonist , decapeptyl , 3.75 mg subcutaneous , single injection , once a month for 3months .


All patients underwent vaginal ultrasound before and after the treatment period to compare the change in the size of endometrioma by the same sonography team in each hospital that was blind to the treatment groups .


The outcome was measured by the changes in the endometrioma size by vaginal ultrasound after completion of the 3months ' treatment period .


The management line was considered to be significantly effective if the endometrioma size was reduced by more than 25 % of its original pretreatment size .


Group I : 46 out of the 71 patients ( 64.7 % ) had significant decrease in endometrioma size .


Group II : 15 out of 69 patients ( 21.7 % ) had significant decrease in endometrioma size .


Paired t test to compare the means of the two groups was highly significant ( p < 0.05 ) CONCLUSION : Cabergoline ( dostinex ) yields better results in decreasing the size of endometrioma , compared to LHRH-agonist by exerting antiangiogenic effects through vascular endothelial growth factor receptor-2 ( VEGFR-2 ) inactivation .


It has no major side effects , easier to administer , and cheaper than LHRH agonists .


Among laboratory technicians , the prevalence of neck and shoulder pain is widespread possibly due to typical daily work tasks such as pipetting , preparing vial samples for analysis , and data processing on a computer including mouse work - all tasks that require precision in motor control and may result in extended periods of time spent in static positions.In populations characterized by intense chronic musculoskeletal pain and diagnosed conditions in conjunction with psycho-physiological symptoms such as stress-related pain and soreness and other disabling conditions , multifactorial approaches applying a combination of individually tailored physical and cognitive strategies targeting the areas most needed , may be an effective solution to the physical and mental health challenges.The aim of this study is therefore to investigate the effect of an individually tailored biopsychosocial intervention strategy on musculoskeletal pain , stress and work disability in lab technicians with a history of musculoskeletal pain at a single worksite in Denmark .


In this single-blind two-armed parallel-group randomized controlled trial with allocation concealment , participants receive either an individualized multifactorial intervention or `` usual care '' for 10 weeks at the worksite .


1 ) female laboratory technician ( 18-67 years of age ) and 2 ) Pain intensity3 ( 0-10 Visual Analogue Scale ) lasting 3 months with a frequency of3 days per week in one or more of the following regions : i ) upper back i ) low back iii ) neck , iv ) shoulder , v ) elbow and/or vi ) hand .


1 ) life-threatening disease and 2 ) pregnancy .