Experimental , blinded , randomized , crossover study .


Six mixed breed dogs ( two males and four females ) weighing 10 4 kg .


The animals were randomly divided into four treatments : D ( 10 g kg ( -1 ) of dexmedetomidine ) , DM ( dexmedetomidine 10 g kg ( -1 ) and methadone 0.5 mg kg ( -1 ) ) ; DMO ( dexmedetomidine 10 g kg ( -1 ) and morphine 0.5 mg kg ( -1 ) ) , and DT ( dexmedetomidine 10 g kg ( -1 ) and tramadol 2 mg kg ( -1 ) ) .


The combinations were administered intramuscularly in all treatments .


The variables evaluated were heart rate ( HR ) , respiratory rate ( f ( R ) ) , rectal temperature ( RT ) , systolic arterial pressure ( SAP ) , sedation scale and pedal withdrawal reflex .


These variables were measured at T0 ( immediately before the administration of the protocol ) and every 15 minutes thereafter until T105 .


A decrease in HR and f ( R ) occurred in all the treatments compared with T0 , but no significant difference was observed between the treatments .


The RT decreased from T45 onward in all the treatments .


The SAP did not show a difference between the treatments , but in the DT treatment , the SAP was lower at T30 and T45 compared with T0 .


The D treatment had lower scores of sedation at T15 to T75 compared with the other treatments , and the DMO and DM treatments showed higher scores at T60 and T75 compared with DT .


The treatments with morphine and methadone added to the dexmedetomidine showed higher sedation scores than the control treatment and the treatment with tramadol added to the dexmedetomidine showed no relevant differences in any of the variables evaluated in the study .


This study was conducted to examine the effects of aerobic exercise training on psychosocial aspects ( mental health , the aspects of physical symptoms , anxiety and insomnia , social functioning , and depression ) in patients with type 2 diabetes mellitus .


53 men who had type 2 diabetes mellitus for a mean duration of the disease for 35 years were selected purposely and classified randomly into experimental ( 27 patients ) and a control group ( 26 patients ) .


Patients in the experimental group did aerobic exercise training three times a week for eight weeks .


The exercise included an aerobic activity for 45 to 60 minutes during which the patients ' heart rates were maintained at 60-70 percent of heart rate reserve on ergo meter bikes .


The eight-week aerobic exercise training had significant effects on mental health ( p = 0.002 ) , subscales of physical symptoms ( p = 0.006 ) , and anxiety and insomnia ( p = 0.001 ) .


It had no significant effects on subscales related to disorder of social functioning ( p = 0.117 ) and depression ( p = 0.657 ) .


Aerobic exercise training can be considered as an appropriate program for improving the health of the patients with type 2 diabetes mellitus , and it also can improve their mental health .


The Whitehall II ( WHII ) study of British civil servants provides a unique source of longitudinal data to investigate key factors hypothesized to affect brain health and cognitive ageing .


This paper introduces the multi-modal magnetic resonance imaging ( MRI ) protocol and cognitive assessment designed to investigate brain health in a random sample of 800 members of the WHII study .


A total of 6035 civil servants participated in the WHII Phase 11 clinical examination in 2012-2013 .


A random sample of these participants was included in a sub-study comprising an MRI brain scan , a detailed clinical and cognitive assessment , and collection of blood and buccal mucosal samples for the characterisation of immune function and associated measures .


Data collection for this sub-study started in 2012 and will be completed by 2016 .


The participants , for whom social and health records have been collected since 1985 , were between 60-85 years of age at the time the MRI study started .


Here , we describe the pre-specified clinical and cognitive assessment protocols , the state-of-the-art MRI sequences and latest pipelines for analyses of this sub-study .


The integration of cutting-edge MRI techniques , clinical and cognitive tests in combination with retrospective data on social , behavioural and biological variables during the preceding 25years from a well-established longitudinal epidemiological study ( WHII cohort ) will provide a unique opportunity to examine brain structure and function in relation to age-related diseases and the modifiable and non-modifiable factors affecting resilience against and vulnerability to adverse brain changes .


Results from the National Lung Cancer Audit demonstrate unexplained variation in outcomes .


Peer review with supported quality improvement has been shown to reduce variation in other areas of health care but has not been formally tested in cancer multidisciplinary teams .


The aim of the current study is to assess the impact of reciprocal peer-to-peer review visits with supported quality improvement and collaborative working on lung cancer process and outcome measures .


English lung cancer teams were randomised to usual care or facilitated reciprocal peer review visits followed by 12 months of supported quality improvement .


The primary outcome was change in the following national audit indicators ; mulitdisciplinary team discussion , histological confirmation , active treatment , surgical resection , small-cell chemotherapy and specialist nurse review .


Patient experience was measured using a new lung cancer patient questionnaire in the intervention group .


Thirty teams ( 31 trusts ) entered the intervention group and 29 of these submitted a total of 67 quality improvement plans .


Active treatment increased in the intervention group ( n = 31 ) by 5.2 % compared with 1.2 % in the control group ( n = 48 , mean difference 4.1 % , 95 % CI -0.1 to 8.2 % , P = 0.055 ) .


The remaining audit indicators improved similarly in all groups .


Mean patient experience scores in the intervention group did not change significantly during the study but a significant improvement was seen in the scores for the five teams with the worst baseline scores ( 0.86 to 0.22 , P < 0.001 ) .


Reciprocal peer review with supported quality improvement was feasible and effective in stimulating quality improvement activity but resulted in only modest improvements in lung cancer treatment rates and patient experience .


Chronic fatigue syndrome or myalgic encephalomyelitis ( CFS/ME ) is a relatively common and potentially serious condition with a limited evidence base for treatment .


Specialist treatment for paediatric CFS/ME uses interventions recommended by National Institute for Health and Clinical Excellence ( NICE ) including cognitive behavioural therapy , graded exercise therapy and activity management .


The Lightning Process ( LP ) is a trademarked intervention derived from osteopathy , life-coaching and neuro-linguistic programming , delivered over three consecutive days as group sessions .


Although over 250 children with CFS/ME attend LP courses each year , there are no reported studies on the effectiveness or cost-effectiveness .


This pragmatic randomised controlled trial is set within a specialist paediatric CFS/ME service in the south west of England .


Children and young people with CFS/ME ( n = 80 to 112 ) , aged 12 to 18 years old will be randomised to specialist medical care ( SMC ) or SMC plus the LP .


The primary outcome will be physical function ( SF-36 physical function short form ) and fatigue ( Chalder Fatigue Scale ) .


This study will tell us whether adding the LP to SMC is effective and cost-effective compared to SMC alone .


This study will also provide detailed information on the implementation of the LP and SMC .


Current Controlled Trials ISRCTN81456207 ( 31 July 2012 ) .


The study was designed to evaluate the effectiveness of the combination of chemonucleolysis and psoas compartment block ( PCB ) for the treatment of lumbar disc herniations ( LDHs ) and to explore the role of PCB in managing postoperative pain of collagenase injection .


Two groups of patients ( N = 192 ) were treated in different ways , respectively .


Group A ( N = 95 ) was treated with chemonucleolysis only ( the injection of oxygen-ozone combined with collagenase into the lumbar disc and the epidural space ) ; group B ( N = 97 ) was treated with chemonucleolysis and PCB .


After the treatment , the patients were followed-up , and the therapeutic effect was assessed at 1 week , 1 month , 3 months , and 6 months by the relative pain reduction , visual analog scale ( VAS ) pain scores , and the Oswestry Disability Index ( ODI ) scores .


In group A , treatment success rate was 64.2 % ( 61 of 95 ) , 82.1 % ( 78 of 95 ) , 84.2 % ( 80 of 95 ) , and 86.3 % ( 82 of 95 ) at 1 week , 1 month , 3 months , and 6 months , respectively .


In group B , treatment success rate was 86.5 % ( 84 of 97 ) , 89.6 % ( 87 of 97 ) , 93.8 % ( 91 of 97 ) , and 91.7 % ( 89 of 97 ) at 1 week , 1 month , 3 months , and 6 months , respectively .


There was statistically significant difference in outcome between two groups at 1 week , but there were no statistically significant difference in outcome between two groups at 1 month , 3 months , and 6 months .


VAS scores and ODI were significantly decreased in both group A and group B , when compared with the baseline values in the same group at all points of follow-up .


Group B produced a significant reduction in the VAS scores and ODI when compared with group A at : 1-week , 1-month , 3-month , 6-month follow-up .


Computer tomography ( CT ) - guided chemonucleolysis combined with PCB leads to rapid pain relief , fewer postoperative pain of collagenase injection happen , and should be regarded as a useful treatment for the management of LDH .


To identify patient and caregiver characteristics associated with caregiver dissatisfaction with hospital care of cognitively impaired elderly adults .


Secondary analysis of data from a randomized controlled trial .


An 1,800-bed general hospital in England providing the only emergency medical services in its area .


Cognitively impaired individuals aged 65 and older randomly assigned to a specialist unit or standard geriatric or internal medical wards ( N = 600 ) and related caregivers ( N = 488 ) .


Patient and caregiver health status was measured at baseline , including delirium , cognitive impairment , behavioral and psychological symptoms , activities of daily living , and caregiver strain .


Caregiver satisfaction with quality of care was ascertained after hospital discharge or death .


Four hundred sixty-two caregivers completed satisfaction questionnaires .


Regardless of assignment , 54 % of caregivers were dissatisfied with some aspects of care , but overall 87 % were satisfied with care .


The main areas of dissatisfaction were communication , discharge planning , and medical management .


Dissatisfaction was associated with high levels of patient behavioral and psychological symptoms on admission , caregiver strain and poor psychological well-being at admission , a diagnosis of delirium , and the relationship between the caregiver and the patient .


There was less dissatisfaction from caregivers of patients managed on the specialist Medical and Mental Health Unit than those on standard wards , after controlling for multiple factors .


Dissatisfaction was associated with patient behavioral and psychological symptoms and caregiver strain but was not immutable to efforts to improve care .


Statins , or 3-hydroxy-3-methylglutaryl coenzyme A ( HMG-CoA ) reductase inhibitors , have anti-inflammatory effects that are independent of their lipid-lowering properties .


Despite suppressive antiretroviral therapy ( ART ) , elevated levels of immune activation and inflammation often persist .


The Stopping Atherosclerosis and Treating Unhealthy Bone With Rosuvastatin in HIV ( SATURN-HIV ) trial is a randomized , double-blind , placebo-controlled study , designed to investigate the effects of rosuvastatin ( 10 mg/daily ) on markers of cardiovascular disease risk in ART-treated human immunodeficiency virus ( HIV ) - infected subjects .


A preplanned analysis was to assess changes in markers of immune activation at week 24 .


Subjects with low-density lipoprotein cholesterol < 130 mg/dL and heightened immune activation ( % CD8 ( + ) CD38 ( + ) HLA-DR ( + ) 19 % , or plasma high-sensitivity C-reactive protein 2 mg/L ) were randomized to receive rosuvastatin or placebo .


We measured plasma ( soluble CD14 and CD163 ) and cellular markers of monocyte activation ( proportions of monocyte subsets and tissue factor expression ) and T-cell activation ( expression of CD38 , HLA-DR , and PD1 ) .


After 24 weeks of rosuvastatin , we found significant decreases in plasma levels of soluble CD14 ( -13.4 % vs 1.2 % , P = .002 ) and in proportions of tissue factor-positive patrolling ( CD14 ( Dim ) CD16 ( + ) ) monocytes ( -38.8 % vs -11.9 % , P = .04 ) in rosuvastatin-treated vs placebo-treated subjects .


These findings were independent of the lipid-lowering effect and the use of protease inhibitors .


Rosuvastatin did not lead to any changes in levels of T-cell activation .


Rosuvastatin treatment effectively lowered markers of monocyte activation in HIV-infected subjects on antiretroviral therapy .


NCT01218802 .


To compare the efficacy of an anhydrous dentifrice containing 0.454 % w/w stannous fluoride and a negative control dentifrice containing 1,000 ppm fluoride , as sodium monofluorophosphate , at reducing dentin hypersensitivity over 8 weeks with twice-daily brushing .


This was a randomized , examiner-blind , parallel , two treatment group , stratified ( by maximum baseline Schiff sensitivity score ) , 8-week clinical study carried out at a single site in 119 healthy subjects with at least two sensitive teeth , who met all study criteria at the screening and baseline visits .


Clinical assessments of sensitivity to evaporative ( air ) [ with Schiff sensitivity score and visual analogue scale ( VAS ) ] and tactile ( Yeaple probe ) stimuli were employed to compare the efficacy of the test dentifrice containing 0.454 % w/w stannous fluoride to the negative control dentifrice at reducing sensitivity after 4 and 8 weeks treatment .


Of the 119 subjects randomized to study treatment , 113 completed the study .


At 4 and 8 weeks , between treatment analyses found the test dentifrice to be significantly better than the negative control dentifrice in relieving dentin hypersensitivity for all measures ( Schiff : P < 0.0001 at 4 and 8 weeks ; VAS score : P = 0.0003 at 4 weeks , P < 0.0001 at 8 weeks ; tactile threshold : P = 0.0138 at 4 weeks , P < 0.0001 at 8 weeks ) .


To discuss the influence of mifepristone to caspase 3 expression in adenomyosis tissue .


Sixty patients were equally divided into four groups .


Groups 1 , 2 , and 3 were treated with 5 , 10 , and 15 mg mifepristone , respectively and group 4 was treated with placebo .


The expression of caspase 3 was examined by immunohistochemical method in both eutopic and ectopic endometria of the 40 cases .


Compared with placebo group , the expression of caspase 3 in both eutopic endometrium and ectopic endometrium in the three treatment groups was significantly increased .


There was no difference in the expression of caspase 3 in both eutopic and ectopic endometria between the ten and 25 mg treatment groups , while both the ten and 25 mg treatment groups had a higher expression intensity of caspase 3 in both eutopic and ectopic endometria , compared with the five mg treatment group ( p < 0.01 ) .


Mifepristone can increase the expression of caspase 3 in both eutopic and ectopic endometria and initiate cell apoptosis in both eutopic and ectopic endometria .


Therefore mifepristone can effectively inhibit the emergence and development of adenomyosis .


The aim of this study was to evaluate the efficacy and safety of intralesional bevacizumab , a monoclonal antibody against vascular endothelial growth factor , in patients with human immunodeficiency virus ( HIV ) - associated Kaposi 's sarcoma of the upper airway receiving antiretroviral therapy .


A pilot randomized , open , phase II study .


HIV-infected patients with Kaposi 's sarcoma lesions of the upper airway in the T0 stage were randomized to receive antiretroviral therapy alone or antiretroviral therapy with intralesional bevacizumab .


The primary end point was the assessment of changes in tumor size according to the Response Evaluation Criteria In Solid Tumors ( RECIST ) ; the secondary end point was safety .


Of the 14 patients with Kaposi 's sarcoma included in the study , seven were assigned to the bevacizumab group and seven to the control group .


The median age was 30.5 years ( interquartile range [ IQR ] , 24.7-38 .2 ) .


Four patients ( 28.5 % ) had > 150 CD4 T cells/mm ( 3 ) .


Nine patients had lesions in the oral cavity ; three patients had pharyngeal disease ; one patient had laryngeal involvement ; and one patient had oral cavity , pharyngeal , and laryngeal involvement .


Four patients had complete response ( 28.5 % ) , two had partial response , six had stable disease , and two had progressive disease .


The median time to complete response was 13 weeks ( IQR , 7.5-36 .5 ) .


No statistical differences between groups were observed ( P = .124 ) .


In the bevacizumab group , one patient had a grade I adverse event , and another patient had a grade II adverse event .


Intralesional administration of bevacizumab was well tolerated but had no impact on upper respiratory tract Kaposi 's sarcoma lesions of HIV-infected patients .


U.S. state AIDS Drug Assistance Programs ( ADAPs ) are federally funded to provide antiretroviral therapy ( ART ) as the payer of last resort to eligible persons with HIV infection .


States differ regarding their financial contributions to and ways of implementing these programs , and it remains unclear how this interstate variability affects HIV treatment outcomes .


We analyzed data from HIV-infected individuals who were clinically-eligible for ART between 2001 and 2009 ( i.e. , a first reported CD4 + < 350 cells/uL or AIDS-defining illness ) from 14 U.S. cohorts of the North American AIDS Cohort Collaboration on Research and Design ( NA-ACCORD ) .


Using propensity score matching and Cox regression , we assessed ART initiation ( within 6 months following eligibility ) and virologic suppression ( within 1 year ) based on differences in two state ADAP features : the amount of state funding in annual ADAP budgets and the implementation of waiting lists .


We performed an a priori subgroup analysis in persons with a history of injection drug use ( IDU ) .


Among 8,874 persons , 56 % initiated ART within six months following eligibility .


Persons living in states with no additional state contribution to the ADAP budget initiated ART on a less timely basis ( hazard ratio [ HR ] 0.73 , 95 % CI 0.60-0 .88 ) .


Living in a state with an ADAP waiting list was not associated with less timely initiation ( HR 1.12 , 95 % CI 0.87-1 .45 ) .


Neither additional state contributions nor waiting lists were significantly associated with virologic suppression .


Persons with an IDU history initiated ART on a less timely basis ( HR 0.67 , 95 % CI 0.47-0 .95 ) .


We found that living in states that did not contribute additionally to the ADAP budget was associated with delayed ART initiation when treatment was clinically indicated .


Given the changing healthcare environment , continued assessment of the role of ADAPs and their features that facilitate prompt treatment is needed .


Randomized trials have indicated a benefit for endovascular therapy in appropriately selected stroke patients at 3 months , but data regarding outcomes at 12 months are currently lacking .


We compared functional and quality-of-life outcomes at 12 months overall and by stroke severity in stroke patients treated with intravenous tissue-type plasminogen activator followed by endovascular treatment as compared with intravenous tissue-type plasminogen activator alone in the Interventional Management of Stroke III Trial .


The key outcome measures were a modified Rankin Scale score 2 ( functional independence ) and the Euro-QoL EQ-5D , a health-related quality-of-life measure .


656 subjects with moderate-to-severe stroke ( National Institutes of Health Stroke Scale 8 ) were enrolled at 58 centers in the United States ( 41 sites ) , Canada ( 7 ) , Australia ( 4 ) , and Europe ( 6 ) .


There was an interaction between treatment group and stroke severity in the repeated measures analysis of modified Rankin Scale 2 outcome ( P = 0.039 ) .


In the 204 participants with severe stroke ( National Institutes of Health Stroke Scale 20 ) , a greater proportion of the endovascular group had a modified Rankin Scale 2 ( 32.5 % ) at 12 months as compared with the intravenous tissue-type plasminogen activator group ( 18.6 % , P = 0.037 ) ; no difference was seen for the 452 participants with moderately severe strokes ( 55.6 % versus 57.7 % ) .


In participants with severe stroke , the endovascular group had 35.2 ( 95 % confidence interval : 2.1 , 73.3 ) more quality-adjusted-days over 12 months as compared with intravenous tissue-type plasminogen activator alone .


Endovascular therapy improves functional outcome and health-related quality-of-life at 12 months after severe ischemic stroke .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT00359424 .


In a recent double-blinded clinical trial , the probiotic combination of Lactobacillus acidophilus NCFM ( L-NCFM ) and B-LBi07 reduced bloating symptoms in patients with functional bowel disorders ; an effect more evident in those who reported abdominal pain .


In mice , L-NCFM but not B-LBi07 induced colonic mu-opioid receptor ( MOR ) and cannabinoid receptor 2 ( CB2 ) expression , and reduced visceral sensitivity .


To determine if L-NCFM was the active component in the clinical trial and to investigate the mechanism of action in humans with mild to moderate abdominal pain .


Caucasian women ( n = 20 ) 18-70 years with mild to moderate abdominal pain were enrolled in a double-blind , two-armed , single-centre study .


Patients were given either L-NCFM alone or in combination with B-LBi07 for 21 days at a total dose of 2 10 ( 10 ) CFU b.d. Colonic biopsies were collected during unsedated , unprepped flexible sigmoidoscopy before and at the end of probiotic consumption .


mRNA and immunostaining were then performed on these biopsies .


Patients kept symptom diaries for the 7 days prior to starting probiotic therapy and for the last 7 days of therapy .


L-NCFM alone , but not with B-LBi07 , induced colonic MOR mRNA and protein expression , as well as downstream signalling , as measured by enterocyte STAT3-phosphorylation .


In contrast , CB2 expression was decreased .


Both treatment groups trended towards improvement in symptoms , but the study was insufficiently powered to draw meaningful conclusions .


Lactobacillus acidophilus NCFM modulates mu-opioid receptor expression and activity , while the combination of L-NCFM and B-LBi07 does not .


This study provides a possible mechanism for action by which probiotics modulates pain sensation in humans ( Clinical Trial Number : NCT01064661 ) .


In Guinea-Bissau we conducted three trials of neonatal vitamin A supplementation ( NVAS ) from 2002 to 2008 .


None of the trials found a beneficial effect on mortality .


From 2003 to 2007 , an early measles vaccine ( MV ) trial was ongoing , randomizing children 1:2 to early MV at 4.5 months or no early MV , in addition to the usual MV at 9 months .


We have previously found interactions between vitamin A and vaccines .


We investigated whether there were interactions between NVAS and early MV .


We compared the mortality of NVAS and placebo recipients : first , from 4.5 to 8 months for children randomized to early MV or no early MV ; and second , from 9 to 17 months in children who had received two MV or one MV .


Mortality rates ( MR ) were compared in Cox models producing mortality rate ratios ( MRR ) .


A total of 5141 children were randomized to NVAS ( N = 3015 ) or placebo ( N = 2126 ) and were later randomized to early MV ( N = 1700 ) or no early MV ( N = 3441 ) .


Between 4.5 and 8 months , NVAS compared with placebo was associated with higher mortality in early MV recipients ( MR = 30 versus MR = 0 , p = 0.01 ) , but not in children who did not receive early MV ( p for interaction between NVAS and early MV = 0.03 ) .


From 9 to 17 months NVAS was not associated with mortality .


Overall , from 4.5 to 17 months NVAS was associated with increased mortality in early MV recipients ( Mortality rate ratio = 5.39 ( 95 % confidence interval : 1.62 , 17.99 ) ) .


These observations indicate that NVAS may interact with vaccines given several months later .


This may have implications for the planning of future child intervention programs .


To evaluate the efficacy and safety of adjunctive eslicarbazepine acetate ( ESL ) in patients with refractory partial-onset seizures .


This randomized , placebo-controlled , double-blind , parallel-group , phase III study was conducted at 173 centers in 19 countries , including the United States and Canada .


Eligible patients were aged 16 years and had uncontrolled partial-onset seizures despite treatment with 1-2 antiepileptic drugs ( AEDs ) .


After an 8-week baseline period , patients were randomized to once-daily placebo ( n = 226 ) , ESL 800 mg ( n = 216 ) , or ESL 1,200 mg ( n = 211 ) .


Following a 2-week titration period , patients received ESL 800 or 1,200 mg once-daily for 12 weeks .


Seizure data were captured and documented using event-entry or daily entry diaries .


Standardized seizure frequency ( SSF ) during the maintenance period ( primary end point ) was reduced with ESL 1,200 mg ( p = 0.004 ) , and there was a trend toward improvement with ESL 800 mg ( p = 0.06 ) , compared with placebo .


When data for titration and maintenance periods were combined , ESL 800 mg ( p = 0.001 ) and 1,200 mg ( p < 0.001 ) both reduced SSF .


There were no statistically significant interactions between treatment response and geographical region ( p = 0.38 ) or diary version ( p = 0.76 ) .


Responder rate ( 50 % reduction in SSF ) was significantly higher with ESL 1,200 mg ( 42.6 % , p < 0.001 ) but not ESL 800 mg ( 30.5 % , p = 0.07 ) than placebo ( 23.1 % ) .


Incidence of treatment-emergent adverse events ( TEAEs ) and TEAEs leading to discontinuation increased with ESL dose .


The most common TEAEs were dizziness , somnolence , nausea , headache , and diplopia .


Adjunctive ESL 1,200 mg once-daily was more efficacious than placebo in adult patients with refractory partial-onset seizures .


The once-daily 800 mg dose showed a marginal effect on SSF , but did not reach statistical significance .


Both doses were well tolerated .


Efficacy assessment was not affected by diary format used .


To determine whether the use of narrow-band imaging ( NBI ) system could enhance the detection rate of esophageal squamous cell carcinoma and precancerous lesions during endoscopic examination of the esophagus .


113 patients were randomized to undergo endoscopic examination using high definition television ( HDTV ) narrow band imaging ( NBI ) endoscopy or HDTV WL endoscopy .


The primary endpoint was the difference in the neoplasm miss rate , and secondary outcome was the neoplasm detection rate .


The number of esophageal cancer and high grade intraepithelial neoplasia lesions detected by HD-NBI and HD-WL was 45 and 21 , respectively .


The neoplasm miss rate per lesion and per patient with HD-NBI showed significant difference compared with that of HD-WL ( P < 0.05 ) .


Characteristics of lesions missed by use of HD-NBI were similar to those missed by use of HD-WL ; all missed lesions were high grade intraepithelial neoplasia lesions .


Significant difference was observed between NBI and WL in adenoma detection rate ( 70.2 % vs. 35.7 % , P < 0.01 ) .


Endoscopy with HD-NBI seems to improve the detection of esophageal cancer and precancerous lesions , high definition may be tested for its effect on detection of esophageal cancer and precancerous lesions in the future .


These results indicate that endoscopy routinely using the NBI system for the surveillance of esophageal cancer and precancerous lesions may be recommended .


This single-center , prospective , randomized , double-blind , 2-arm , parallel group comparison trial was performed to establish whether the adult-sized laryngeal mask airway ( LMA ) Classic ( The Laryngeal Mask Company Ltd , Henley-on-Thames , UK ) could be used safely without any consideration of cuff hyperinflation when a cuff of the LMA Classic was inflated using half the maximum inflation volume or the resting volume before insertion of device .


Eighty patients aged 20 to 70 years scheduled for general anesthesia using the LMA Classic were included .


Before insertion , the cuff was partially filled with half the maximum inflation volume in the half volume group or the resting volume created by opening the pilot balloon valve to equalize with atmospheric pressure in the resting volume group .


Several parameters regarding insertion , intracuff pressure , airway leak pressure , and leakage volume/fraction were collected after LMA insertion .


The LMA Classic with a partially inflated cuff was successfully inserted in all enrolled patients .


Both groups had the same success rate of 95 % at the first insertion attempt .


The half volume group had a lower mean intracuff pressure compared with the resting volume group ( 54.5 16.1 cm H2O vs 61.8 16.1 cm H2O ; P = .047 ) .


There was no difference in airway leak pressure or leakage volume/fraction between the 2 groups under mechanical ventilation .


The partially inflated cuff method using half the maximum recommended inflation volume or the resting volume is feasible with the adult-sized LMA Classic , resulting in a high success rate of insertion and adequate range of intracuff pressures .


With advances in imaging and radiotherapy , the prognostic value of skull-base invasion in nasopharyngeal carcinoma ( NPC ) needs to be reassessed .


We aimed to define a classification system and evaluate the prognostic value of the classification of magnetic resonance imaging ( MRI ) - detected skull-base invasion in NPC treated with intensity-modulated radiotherapy ( IMRT ) .


We retrospectively reviewed 749 patients who underwent MRI and were subsequently histologically diagnosed with nondisseminated NPC and treated with IMRT .


MRI-detected skull-base invasion was not found to be an independent prognostic factor for overall survival ( OS ) , distant metastasis-free survival ( DMFS ) , local relapse-free survival ( LRFS ) , or disease-free survival ( DFS ; p > 0.05 for all ) .


Skull-base invasion was classified according to the incidence of each site ( type I sites inside pharyngobasilar fascia and clivus vs. type II sites outside pharyngobasilar fascia ) .


The 5-year OS , DMFS , LRFS , and DFS rates in the classification of skull-base invasion in NPC were 83 vs. 67 % , 85 vs. 75 % , 95 vs. 88 % , and 76 vs. 62 % , respectively ( p < 0.05 for all ) .


Multivariate analysis indicated the classification of skull-base invasion was an independent prognostic factor .


MRI-detected skull-base invasion is not an independent prognostic factor in patients with NPC treated with IMRT .


However , classification according to the site of invasion has prognostic value .


Therefore , patients with various subclassifications of stage T3 disease may receive treatment with different intensities ; however , further studies are warranted to prove this .


Remote Patient Management for chronic heart failure ( CHF ) is gaining increasing importance in health care .


Telemonitoring is defined as daily measuring of health parameters by the patient and their transmission to a telemedical centre .


The adherence of this action by the patient can be considered as a measure for RPM adoption .


The randomized controlled clinical trial TIM-HF ( NCT 00543881 ) was conducted between 2008 and 2010 with 710 CHF patients with the primary endpoint total mortality for a mean follow-up of 21.5 7.2 months .


The non-prespecified analysis of adherence to daily measuring of ECG , blood pressure , weight and self-assessment was focused on sociodemographic and disease-related factors of the 354 RPM patients .


The mean adherence to telemonitoring was more than 80 % ( absolute adherence : 81.8 22.8 % , relative adherence : 88.9 21.5 % ) .


From the beginning of treatment 6.5 % of the patients ( 23/354 ) have shown an adherence below average .


The high adherence of the majority of the patients was stable for the entire study duration and irrespective of age , sex , severity of the disease and the presence of mild to moderate depression .


A high adherence can be achieved by individual training of the patient regarding the handling of his disease , the use of telemedical devices and an easy-to-use telemonitoring system .


The majority of the informed self-determined CHF patients NYHA class II/III are adopting telemonitoring and are adherent in the long term .


Improved smoking cessation rates are urgently required if New Zealand is to reach its target of a smokefree nation by 2025 , during which some 600,000 smokers will need to quit .


Nicotine replacement therapy remains a core part of the pharmacological approach to smoking cessation .


Oral nicotine solutions with rapid onset have recently become available .


We have examined the effect of a nicotine spray and a nicotine patch on smoking cessation for 12 months .


We enrolled potential participants-smokers wanting to quit aged 18-70 years , who smoked 9 cigarettes per day-with Fagerstrm Test of Nicotine Dependence score 3 in a double-blind trial in 3 trial sites .


Smokers were randomized to a nicotine or placebo spray for 6 months , and all received nicotine patches daily for 5 months .


They were followed at regular intervals for 12 months .


A total of 1,423 subjects were randomized to nicotine oral spray ( 1mg of nicotine free base per spray ) plus nicotine patch or a placebo spray and nicotine patch .


The nicotine mouth spray plus nicotine patch showed significant improvements in prolonged abstinence for all measures to 6 months ( 7 consecutive days at each visit for 6 months : 15.5 % vs. 10.6 % ; p = .006 ) for the combination versus placebo and nicotine patch .


Thereafter , the differences were not significant .


The addition of a nicotine mouth spray to a nicotine replacement patch in a population of smokers receiving a low level of behavioral support improved early quitting , but the effects were not sustained .


Improving the carbohydrate quality of the diet by replacing the common cereal staple white rice ( WR ) with brown rice ( BR ) could have beneficial effects on reducing the risk for diabetes and related complications .


Hence we aimed to compare the effects of BR , WR , and BR with legumes ( BRL ) diets on 24-h glycemic and insulinemic responses among overweight Asian Indians .


Fifteen overweight ( body mass index , 23 kg/m ( 2 ) ) Asian Indians without diabetes who were 25-45 years old participated in a randomized crossover study .


Test meals ( nonisocaloric , ad libitum ) were identical except for the type of rice and the addition of legumes ( 50 g/day ) and were provided for 5 consecutive days .


Glucose profiles were assessed using the Medtronic MiniMed ( Northridge , CA ) iPro2 continuous glucose monitoring device .


The mean positive change from baseline glucose concentration was calculated as the daily incremental area under the curve ( IAUC ) on each test day for 5 days and averaged .


Fasting serum insulin was measured prior to and at the end of each test diet .


The percentage difference in 5-day average IAUC was 19.8 % lower in the BR group than in the WR group ( P = 0.004 ) .


BRL further decreased the glycemic response ( 22.9 % lower compared with WR ( P = 0.02 ) .


The 5-day percentage change in fasting insulin was 57 % lower ( P = 0.0001 ) for the BR group and 54 % lower for the BRL group compared with the 5-day percentage change observed in the WR group .


The glycemic and insulinemic responses to the BR and BRL diets were not significantly different .


Consumption of BR in place of WR can help reduce 24-h glucose and fasting insulin responses among overweight Asian Indians .


To investigate the effects of combination cathodal transcranial direct current stimulation ( tDCS ) and virtual reality ( VR ) therapy for upper extremity ( UE ) training in patients with subacute stroke .


Pilot randomized controlled trial .


Patients were randomly assigned to 1 of 3 groups : group A received cathodal tDCS , group B received VR , and group C received combination therapy ( cathodal tDCS was simultaneously applied during VR therapy ) .


University hospital .


Patients ( N = 59 ) with impaired unilateral UE motor function after stroke .


Fifteen sessions of treatment over a 3-week period .


The Modified Ashworth Scale , manual muscle test ( MMT ) , Manual Function Test ( MFT ) , Fugl-Meyer Scale ( FMS ) , and Box and Block Test were used to assess UE function .


To evaluate activities of daily living , the Korean-Modified Barthel Index ( K-MBI ) was used .


All outcomes were measured before and immediately after treatment .


After treatment , all groups demonstrated significant improvements in MMT , MFT , FMS , and K-MBI scores .


The change in MFT and FMS scores was different between the 3 groups .


Post hoc analysis revealed that the improvement of MFT and FMS scores in group C was significantly higher than those of the other 2 groups .


In the present pilot study , the combination of brain stimulation using tDCS and peripheral arm training using VR could facilitate a stronger beneficial effect on UE impairment than using each intervention alone .


This combination therapy might be a helpful method to enhance recovery of the paretic UE in patients with stroke .


To evaluate the safety and efficacy of once-weekly subcutaneous rilonacept 160 mg for prevention of gout flares in patients initiating or continuing urate-lowering therapy ( ULT ) .


This phase III study was conducted in the United States , South Africa , Europe , and Asia .


Adults ( n = 1315 , 18-80 yrs ) with gout , who were initiating or continuing ULT , were randomized to treatment with weekly subcutaneous injections of rilonacept 160 mg or placebo for 16 weeks followed by a 4-week safety followup .


The primary endpoint was safety , assessed by adverse events ( AE ) and laboratory values .


Efficacy was a secondary endpoint .


Demographic and clinical characteristics were similar between treatments ; predominantly male ( 87.8 % ) , mean age 52.7 11.3 years .


Patients with 1 AE were 66.6 % with rilonacept versus 59.1 % placebo , with slightly more AE-related withdrawals with rilonacept ( 4.7 % vs 3.0 % ) because of the greater incidence of injection site reactions ( 15.2 % rilonacept , 3.3 % placebo ) .


Serious AE were similar in both groups , as were serious infections ( 0.9 % placebo , 0.5 % rilonacept ) ; no tuberculosis or opportunistic infections occurred .


Most common AE were headache , arthralgia , injection site erythema , accidental overdose , and pain in extremity .


Of the 6 deaths , only 1 in the placebo group was considered treatment-related .


At Week 16 , rilonacept resulted in 70.3 % fewer gout flares per patient ( p < 0.0001 ) , fewer patients with 1 and 2 gout flares ( p < 0.0001 ) , and 64.9 % fewer gout flare days ( p < 0.0001 ) relative to placebo .


Weekly subcutaneous administration of rilonacept 160 mg showed no new safety signals .


The safety profile was consistent with previous studies .


Rilonacept also significantly reduced the risk of gout flares .


Clinicaltrials.gov identifier NCT00856206 ; EudraCT No. 2008-007784-16 .


Haemodiafiltration ( HDF ) with high reinfusion volumes is the most effective technique for clearing uraemic toxins .


There are various modalities depending on the location where the replacement volume is administered in the extracorporeal circuit : pre-dilution , mixed or mid-dilution and post-dilution , in which the infusion is carried out pre-dilution , pre - and post-dilution simultaneously and post-dilution , respectively .


Compare the clearance of small , medium-sized and protein-bound molecules and the convective volume administered in online HDF ( OL-HDF ) in post-dilution and mixed ( pre-post-dilution ) infusion .


A prospective , randomised , crossover study comparing post-dilution and mixed OL-HDF .


Patients ( n = 8 ) were randomly assigned to receive 6 sessions in each technique .


We conducted 89 sessions , of which 68 were at a scheduled time ( ST ) and 21 at an effective time ( ET ) .


We determined the reduction rate ( RR ) percentages for various substances and the infusion volumes .


The RR study was performed using ET .


The KT value obtained was greater with post-dilution OL-HDF [ 68 ( 8.1 ) compared to 64.9 ( 8.8 ) litres ] ( P = .009 ) when patients were dialysed at ST. This difference disappeared when dialysis was performed at ET .


The difference between ST and ET was greater in mixed HDF than in post-dilution HDF [ 10.3 ( 7.4 ) compared to 6.5 ( 3.1 ) minutes , P = .02 ] .


We found no differences in the RR of the substances analysed .


Mixed OL-HDF is not inferior to post-dilution OL-HDF either in the clearance of small and medium-sized molecules or in the clearance of protein-bound molecules at the same ET .


Prescribing inhalers without imparting adequate education regarding proper technique of their usage may result in suboptimal clinical improvement and wastage of medication .


Training interventions using a standard check-list may help improve faulty techniques and enhance drug efficacy .


Patients using metered dose inhaler ( MDI ) were included in the study .


Inhaler technique was first evaluated at baseline using a standard check-list of recommended steps ( National Institute of Health guidelines ; see Table ) and scores were given for each step correctly performed .


Those who could not perform all steps correctly were given training intervention .


The patients were assigned to two methods of educational intervention ; one group was trained by providing written material giving step-wise instructions while the other group was given an actual physical demonstration using a placebo device .


The technique was re-evaluated and scored following each educational session , and continued till the patient achieved a full score , or for a maximum of 3 sessions , whichever occurred earlier .


Median score was calculated after each session and was compared between the two groups .


Each patient was followed up after two months and the re-evaluated the same way .


One hundred and seventeen subjects were enrolled in the study ( 59 in the written group and 57 in the practical demonstration group ) .


At baseline , only 1 of the 117 subjects could perform all the steps of inhaler usage correctly .


This patient was , therefore , not provided the inhaler technique education .


The overall median ( range ) score of the whole group was 3 ( range 1-8 ) .


This score rose to 6 , 7 and 8 after each of the three subsequent educational intervention sessions .


At one-month follow-up , the median score dropped to 7 and improved with a repeat educational session as previously done .


A significant difference was observed in the median score improvement achieved in the practical demonstration group compared with the written instruction group ( 3.0 versus 2.0 respectively , p < 0.001 ) .


Inhalation technique of patients improves after imparting systematic educational intervention .


A practical demonstration of all the steps proved more effective than simple verbal/written advice .


In view of increasing errors being committed over a period of time , repeated demonstration of the proper technique using a standard check-list significantly improves the errors committed during inhaler use .


Cigarette smoking leads to upregulation of nicotinic acetylcholine receptors ( nAChRs ) in the human brain , including the common 42 * nAChR subtype .


While subjective aspects of tobacco dependence have been extensively examined as predictors of quitting smoking with treatment , no studies to our knowledge have yet reported the relationship between the extent of pretreatment upregulation of nAChRs and smoking cessation .


To determine whether the degree of nAChR upregulation in smokers predicts quitting with a standard course of treatment .


Eighty-one tobacco-dependent cigarette smokers ( volunteer sample ) underwent positron emission tomographic ( PET ) scanning of the brain with the radiotracer 2-FA followed by 10 weeks of double-blind , placebo-controlled treatment with nicotine patch ( random assignment ) .


Pretreatment specific binding volume of distribution ( VS/fP ) on PET images ( a value that is proportional to 42 * nAChR availability ) was determined for 8 brain regions of interest , and participant-reported ratings of nicotine dependence , craving , and self-efficacy were collected .


Relationships between these pretreatment measures , treatment type , and outcome were then determined .


The study took place at academic PET and clinical research centers .


Posttreatment quit status after treatment , defined as a participant report of 7 or more days of continuous abstinence and an exhaled carbon monoxide level of 3 ppm or less .


Smokers with lower pretreatment VS/fP values ( a potential marker of less severe nAChR upregulation ) across all brain regions studied were more likely to quit smoking ( multivariate analysis of covariance , F8 ,69 = 4.5 ; P < .001 ) , regardless of treatment group assignment .


Furthermore , pretreatment average VS/fP values provided additional predictive power for likelihood of quitting beyond the self-report measures ( stepwise binary logistic regression , likelihood ratio 21 = 19.8 ; P < .001 ) .


Smokers with less upregulation of available 42 * nAChRs have a greater likelihood of quitting with treatment than smokers with more upregulation .


In addition , the biological marker studied here provided additional predictive power beyond subjectively rated measures known to be associated with smoking cessation outcome .


While the costly , time-consuming PET procedure used here is not likely to be used clinically , simpler methods for examining 42 * nAChR upregulation could be tested and applied in the future to help determine which smokers need more intensive and/or lengthier treatment .


clinicaltrials.gov Identifier : NCT01526005 .


The purpose of this study was to describe the process of implementing a diabetes prevention program provided by homecare nurses to residents of public housing communities .


A cluster randomization pilot study was conducted comparing enhanced standard care ( 2 interactive classes on diabetes prevention ) to a diabetes prevention program ( 7 interactive classes and behavioral support ) .


The sample ( n = 67 ) was primarily female ( 79 % ) , nonwhite ( 76 % ) , unpartnered ( 83 % ) , with a mean age of 40 years , and an average of 3 children .


Mixed methods were used to evaluate the implementation process .


Data were collected on attendance , attrition , and protocol implementation .


Interviews were conducted with nurses and community health workers who assisted with program implementation .


Homecare nurses were able to implement a diabetes prevention program in public housing communities , with a protocol implementation of 83 % across classes and groups .


Attendance was suboptimal with 60 % for the enhanced standard care group and 54 % for the diabetes prevention group .


Nurses and community health workers were resourceful and positive about program implementation .


Linking existing resources , such as a homecare agency with a public housing community , is one approach to disseminate diabetes prevention programs .


Randomized studies have shown optimal medical therapy to be as efficacious as revascularization in stable ischemic heart disease ( IHD ) .


It is not known if these efficacy results are reflected by real-world effectiveness .


To evaluate the comparative effectiveness of routine medical therapy versus revascularization with percutaneous coronary intervention ( PCI ) or coronary artery bypass grafting ( CABG ) in stable IHD .


Observational cohort study .


Stable IHD patients from 1 October 2008 to 30 September 2011 , identified using a Registry of all angiography patients in Ontario , Canada .


Revascularization , defined as PCI/CABG within 90 days after index angiography .


Death , myocardial infarction ( MI ) or repeat PCI/CABG .


Revascularization was compared to medical therapy using a ) multivariable Cox-proportional hazard models with therapy strategy treated as a time-varying covariate ; and b ) a propensity score matched analysis .


Post-angiography medication use was determined .


We identified 39,131 stable IHD patients , of whom 15,139 were treated medically , and 23,992 were revascularized ( PCI = 15,604 ; CABG = 8,388 ) .


Mean follow-up was 2.5 years .


Revascularization was associated with fewer deaths ( HR 0.76 ; 95 % CI 0.68-0 .84 ; p < 0.001 ) , MIs ( HR 0.78 ; 95 % CI 0.72-0 .85 ; p < 0.001 ) and repeat PCI/CABG ( HR 0.59 ; 95 % CI 0.50-0 .70 ; p < 0.001 ) than medical therapy .


In the propensity-matched analysis of 12,362 well-matched pairs of revascularized and medical therapy patients , fewer deaths ( 8.6 % vs 12.7 % ; HR 0.75 ; 95 % CI 0.69-0 .81 ; p < 0.001 ) , MIs ( 11.7 % vs 14.4 % ; HR 0.84 ; 95 % CI 0.77-0 .93 p < 0.001 ) and repeat PCI/CABG ( 17.4 % vs 24.1 % ; HR 0.67 ; 95 % 0.63-0 .71 ; p < 0.001 ) occurred in revascularized patients , over the 4.1 years of follow-up .


The revascularization patients had higher uptake of clopidogrel ( 70.3 % vs 27.2 % ; p < 0.001 ) , - blockers ( 78.2 % vs 76.7 % ; p = 0.010 ) , and statins ( 94.7 % vs 91.5 % , p < 0.001 ) in the 1-year post-angiogram .


Stable IHD patients treated with revascularization had improved risk-adjusted outcomes in clinical practice , potentially due to under-treatment of medical therapy patients .


Colonoscopy is the most frequent exam used to evaluate colonic mucosa , allowing the diagnosis and treatment of many diseases .


The appropriate bowel preparation is indispensable for the realization of colonoscopy .


Therefore , it is necessary the use of laxative medications , preferentially by oral administration .


To compare two medications used in bowel preparation in adult patients going to ambulatory colonoscopy and to analyze the patients ' profile .


A double-blind prospective study with 200 patients , randomized in two groups : one that received polyethilene glycol and another that received lactulose .


The patients answered to questionnaires to data compilation , as tolerance , symptoms and complications related to preparation .


Besides , it was also evaluated the prepare efficacy related to the presence of fecal residue .


Intestinal habit alterations and abdominal pain were the main reasons to realize the exams and hypertension was the most prevalent comorbidity .


Ten percent of the ones who received lactulose did n't get to finish the preparation and 50 % considered the taste `` bad , but tolerable '' .


The most common subjective symptom after the medication was nausea , especially after lactulose .


During the exam , most of the patients who used lactulose had a `` light discomfort '' and the ones who used polyethilene glycol considered the discomfort as `` tolerable '' .


The quality of the preparation was good in 75 % , undependable of the medication that was used .


Polyethilene glycol was more tolerable when compared to lactulose , without difference on the quality of the preparation .


To compare preservative-free ketotifen 0.025 % ophthalmic solution to olopatadine 0.1 % ophthalmic solution in with the treatment of seasonal allergic conjunctivitis ( SAC ) in clinical practice .


This was a comparative , randomised , investigator-masked , pilot clinical study in adult patients with documented history of SAC and presenting with moderate to severe itching and conjunctival hyperemia .


Eligible patients initiated either ketotifen or olopatadine treatment at a dose of one drop twice daily for 28days .


The resolution of ocular signs and symptoms was assessed on day 7 and day 28 .


Itching was also assessed within 15minutes following the first instillation ( day 0 ) .


Conjunctival impression cytology was performed at each visit to assess the evolution of ICAM-1 expression ( day 0 , 7 and 28 ) .


Seventy-five patients were randomised ( ketotifen : 38 patients ; olopatadine : 37 patients ) .


At day 28 , the composite score for primary criteria ( itching , tearing , and conjunctival hyperemia ) improved from 6.81.2 to 0.91.0 in the Ketotifen group , without statistically significant difference between treatment groups ( P = 0.67 ) .


There was no relevant difference between treatment groups in other efficacy parameters , except a trend for a more rapid resolution of conjunctival hyperemia in the Ketotifen group .


Both drugs were well tolerated , with a trend for a better tolerability reported by patients on ketotifen compared to those on olopatadine at day 7 ( P = 0.054 ) .


A rapid and comparable improvement in SAC was achieved after 28days of treatment with both preservative-free ketotifen and preserved olopatadine ophthalmic solutions , with a slightly better ocular tolerance with unpreserved ketotifen 0.025 % eye drops .


Adalimumab is a fully human , monoclonal antibody against tumor necrosis factor that is approved in Western countries for the treatment of moderately to severely active ulcerative colitis ( UC ) .


This 52-week , phase 2/3 , randomized , double-blind study evaluated adalimumab for induction and maintenance treatment in 273 anti-TNF-naive Japanese patients with UC who were refractory to corticosteroids , immunomodulators , or both .


Patients received placebo , adalimumab 80/40 ( 80mg at week 0 , then 40mg every other week ) , or adalimumab 160/80 ( 160/80mg at weeks 0/2 , then 40mg every other week ) in addition to background UC therapy .


At week 8 , remission rates were similar among treatment arms , but more patients treated with adalimumab 160/80 achieved response ( placebo , 35 % ; 80/40 , 43 % ; 160/80 , 50 % ; P = 0.044 for 160/80 vs placebo ) and mucosal healing ( placebo , 30 % ; 80/40 , 39 % ; 160/80 , 44 % ; P = 0.045 for 160/80 vs placebo ) compared with placebo .


At week 52 , more patients receiving adalimumab 40mg every other week achieved response ( 18 vs 31 % ; P = 0.021 ) , remission ( 7 vs 23 % ; P = 0.001 ) , and mucosal healing ( 16 vs 29 % ; P = 0.015 ) compared with placebo .


Week 8 response to adalimumab was associated with greater rates of response ( 61 % ) , remission ( 46 % ) , and mucosal healing ( 57 % ) at week 52 relative to the overall population .


Rates of serious adverse events were similar between treatment arms .


Induction with adalimumab 160/80mg led to early response and mucosal healing .


Maintenance adalimumab had greater rates of long-term response , remission , and mucosal healing compared with placebo .


No new safety signals were identified .


Electrical reconnection of the pulmonary veins ( PVs ) plays a key role in the recurrence of atrial fibrillation ( AF ) after ablative treatment .


This randomized controlled study tested the hypothesis that prolonged ablations , on areas that may be critical for left atrial ( LA ) - PV conduction , can significantly reduce the rate of acute PV reconnection and AF recurrence .


Patients with paroxysmal AF were randomly assigned to either a control or an add-on group.Ostial PV isolation ( PVI ) was performed by point-to-point RF ablation ( irrigated tip , 30 Watts , 30 seconds ) .


An ostial segment was assumed to be critical for LA-PV connection if any of the following reactions occurred during RF application : ( 1 ) sudden delay of LA-PV conduction , ( 2 ) change of activation sequence , and ( 3 ) PVI .


In this case , RF application was prolonged from 30 seconds to 90 seconds in the add-on group only .


A total of 131 patients ( 58 11 years , 47 female ) were assigned to a control ( n = 64 ) and an add-on ( n = 67 ) group .


Ablation time was longer in the add-on ( 48 16 minutes vs 37 15 minutes , P = 0.03 ) .


Acute PV reconnection was observed in 20 of 64 controls and in eight of 66 add-on patients ( 31 % vs 12 % , P < 0.001 ) .


During a follow-up of 26 months , AF recurred in 33 of 64 controls and in 16 of 66 add-on patients ( 52 % vs 24 % , P = 0.001 ) after a single ablation procedure .


Prolonged radiofrequency application on critical segments of LA-PV connection is a safe and effective ablative strategy that significantly reduces acute PV reconnection and AF recurrence rates after a single ablation procedure for paroxysmal AF .


Low-contrast visual acuity ( LCVA ) , a sensitive measure of visual function in multiple sclerosis ( MS ) , demonstrated treatment effects as a secondary outcome measure in the Phase 3 trial of natalizumab , AFFIRM .


In these posttrial analyses , we studied the relation of visual function to quality of life ( QOL ) , magnetic resonance imaging ( MRI ) measures , and Expanded Disability Status Scale ( EDSS ) scores .


At baseline and at 52 and 104 weeks in AFFIRM , patients underwent binocular testing of LCVA ( 1.25 % and 2.5 % contrast ) and high-contrast visual acuity ( HCVA ) .


Vision-specific QOL was assessed by the Impact of Visual Impairment Scale ( IVIS ) , whereas the SF-36 Health Survey and Visual Analog Scale were administered as generic QOL measures and the EDSS as a measure of neurologic impairment .


Among QOL measures , IVIS scores showed the most significant correlations with visual dysfunction at all time points in the trial ( r = -0.25 to -0.45 , P < 0.0001 for LCVA and HCVA ) .


Higher MRI T1 - and T2-lesion volumes were also associated with worse vision scores at all time points ( P < 0.0001 ) .


Clinically meaningful worsening ( progression ) of LCVA was noted in substantial proportions of patients in AFFIRM and was prevalent even among those without EDSS progression over 2 years ( 21.9 % with LCVA progression at 2.5 % contrast ; 26.2 % at 1.25 % contrast ) .


HCVA worsened in only 3.7 % of patients without EDSS progression .


Loss of visual function , particularly as measured by LCVA , was common in AFFIRM , occurring in > 20 % of patients .


Both LCVA and HCVA scores reflect vision-specific aspects of QOL , but LCVA provides information about disability progression not entirely captured by the EDSS .


Vision represents a key dimension of outcome assessment for MS and adds valuable information on disability and QOL that can be useful to clinicians .


The objective of this study was to assess and compare the features of the Bemfola , Gonal-f and Puregon injection pens .


Females who intended to undergo hormonal treatment received the three different pens in a randomized , consecutive sequence .


For each of the pens , the potential patients completed an Injection Pen Assessment Questionnaire , as well as a questionnaire comparing the handling , convenience and preference among the three pens .


The mean score on the visual analogue scale ( VAS ) for the Bemfola pen ( BP ) was 77.8 14.0 ; for the Puregon pen ( PP ) , 72.1 12.4 ; and for the Gonal-f pen ( GP ) , 68.6 16.4 .


The BP was superior to both competitor devices in pen size , inconspicuousness , ease of use and dose changing ; no significant differences to both competitor pens were observed in the way the pen looks , the way the pen feels and the ease of injection of the volume .


The ` overall ' assessment was significantly better for the BP when compared to the GP ( p = 0.0019 ) , while no significant difference was observed between the BP and the PP .


This study demonstrated significantly higher ratings for pen size , inconspicuousness , ease of use and dose adjustment for the BP compared to other marketed pens .


To investigate the effects , and their reversibility , of multiple oral voriconazole doses on a variety of visual tests in healthy male volunteers .


Single-center , double-blind , randomized , placebo-controlled , parallel-group study in 36 volunteers who received voriconazole ( n = 18 , 400 mg every 12 h on day 1 , then 300 mg every 12 h for 27.5 days ) or matched placebo ( n = 18 ) .


Electroretinograms ( ERGs ) and ophthalmological examinations were performed at screening , throughout the study and at follow-up .


Fifteen ( 83.3 % ) volunteers treated with voriconazole experienced 1 treatment-related visual adverse events ( AEs ) ; these included enhanced visual perceptions , blurred vision , color vision changes and photophobia .


No serious AEs were reported .


Voriconazole reduced from baseline scotopic maximal a - and b-wave amplitude , shortened implicit time and decreased oscillatory potential amplitude compared with placebo .


Under photopic conditions , the 30-Hz flicker response amplitude was significantly reduced and was accompanied by a slight but nonsignificant prolongation of peak time .


These effects did not progress in degree over the treatment period , and mean changes from baseline in ERG parameters were similar to placebo by day 43 ( 14 days after end of treatment ) .


In the first week , color vision discrimination was impaired in the tritan axis , although this resolved by end of treatment and was similar to placebo by day 43 .


Mean deviation in the static visual field indicated increased sensitivity following voriconazole treatment , correlating with decreased amplitude in conjunction with shortened implicit time .


Effects of voriconazole on altered visual perception , ERG , color vision and static visual field thresholds are nonprogressive over a treatment period and reversible .


It is hypothesized that voriconazole has a pharmacological effect on rod and cone pathways including a possible mechanism of disinhibition that reversibly puts the retina in a more light-adapted state and leads to increased relative contrast sensitivity .


Acute exacerbations of chronic obstructive pulmonary disease ( AECOP ) are key events in the natural history of the disease .


Patients with more AECOPD have worse prognosis .


There is a need of innovative models of care for patients with severe COPD and frequent AECOPD , and Telehealth ( TH ) is part of these programs .


In a cluster assignment , controlled trial study design , we recruited 60 patients , 30 in home telehealth ( HT ) and 30 in conventional care ( CC ) .


All participants had a prior diagnosis of COPD with a post-bronchodilator forced expiratory volume ( FEV1 ) % predicted < 50 % , age 50 years , were on long-term home oxygen therapy , and non-smokers .


Patients in the HT group measured their vital signs on a daily bases , and data were transmitted automatically to a Clinical Monitoring Center for followed-up , and who escalated clinical alerts to a Pneumologist .


After 7-month of monitoring and follow-up , there was a significant reduction in ER visits ( 20 in HT vs. 57 in CC ) , hospitalizations ( 12 vs. 33 ) , length of hospital stay in ( 105 vs. 276 days ) , and even need for non-invasive mechanical ventilation ( 0 vs. 8 ) , all p < 0.05 .


Time to the first severe AECOPD increased from 77 days in CC to 141 days in HT ( K-M p < 0.05 ) .


There was no study withdrawals associated with technology .


All patients showed a high level of satisfaction with the HT program .


We conclude that HT in elderly , severe COPD patients with multiple comorbidities is safe and efficacious in reducing healthcare resources utilization .


To evaluate whether premature infants who received an exclusive human milk ( HM ) - based diet and a HM-derived cream supplement ( cream ) would have weight gain ( g/kg/d ) at least as good as infants receiving a standard feeding regimen ( control ) .


In a prospective noninferiority , randomized , unmasked study , infants with a birth weight 750-1250 g were randomly assigned to the control or cream group .


The control group received mother 's own milk or donor HM with donor HM-derived fortifier .


The cream group received a HM-derived cream supplement if the energy density of the HM tested < 20 kcal/oz using a near infrared HM analyzer .


Infants were continued on the protocol until 36 weeks postmenstrual age .


Primary outcomes included growth velocities and amount of donor HM-derived fortifier used .


The hypothesis of noninferiority was established if the lower bound of the one-sided 95 % CI for the difference in weight velocities exceeded -3 g/kg/day .


There were no differences between groups in baseline demographics for the 78 infants studied except racial distribution ( P = .02 ) .


The cream group ( n = 39 ) had superior weight ( 14.0 2.5 vs 12.4 3.0 g/kg/d , P = .03 ) and length ( 1.03 0.33 vs 0.83 0.41 cm/wk , P = .02 ) velocity compared with the control group ( n = 39 ) .


There were no significant differences in amount of fortifier used between study groups .


The 1-sided 95 % lower bound of the CI for the difference in mean velocity ( cream-control ) was 0.38 g/kg/d .


Premature infants who received HM-derived cream to fortified HM had improved weight and length velocity compared with the control group .


HM-derived cream should be considered an adjunctive supplement to an exclusive HM-based diet to improve growth rates in premature infants .


Serum markers are used before pelvic imaging to improve specificity and positive predictive value ( PPV ) of ovarian cancer multimodal screening strategies .


We conducted a randomized controlled pilot trial to estimate surgical PPV of a `` 2 of 3 tests positive '' screening rule , and to compare use of HE4 as a first-line ( Arm 1 ) versus a second-line ( Arm 2 ) screen , in women at high and elevated risk for epithelial ovarian cancer ( EOC ) at five study sites .


Semiannual screening was offered to 208 women ages 25 to 80 years with deleterious BRCA germline mutations and to 834 women ages 35 to 80 years with pedigrees suggesting inherited susceptibility .


Annual screening was offered to 130 women ages 45 to 80 years ( Risk Group 3 ) with epidemiologic and serum marker risk factors .


Rising marker levels were identified using the parametric empirical Bayes algorithm .


Both strategies yielded surgical PPV above 25 % .


Protocol-indicated surgery was performed in 6 women , identifying two ovarian malignancies and yielding a surgical PPV in both arms combined of 33 % ( 95 % confidence interval : 4 % -78 % ) , 25 % in Arm 1 and 50 % in Arm 2 .


Surgical consultation was recommended for 37 women ( 26 in Arm 1 and 11 in Arm 2 ) .


On the basis of 12 women with at least 2 of 3 tests positive ( CA125 , HE4 , or imaging ) , an intent-to-treat analysis yielded PPV of 14 % in Arm 1 and 20 % in Arm 2 .


Positive screens were more frequent when HE4 was included in the primary screen .


HE4 may be useful as a confirmatory screen when rising CA125 is used alone as a primary screen .


Following traumatic brain injury ( TBI ) , individuals may experience chronic problems with irritability or aggression , which may need treatment to minimize the negative impact on their relationships , home life , social interactions , community participation , and employment


: To test the a priori hypothesis that amantadine reduces irritability ( primary hypothesis ) and aggression ( secondary hypothesis ) among individuals greater than 6 months post-TBI METHODS : : A total of 76 individuals greater than 6 months post-TBI referred for irritability management were enrolled in a parallel-group , randomized , double-blind , placebo-controlled trial of amantadine ( n = 38 ) versus placebo ( n = 38 ) .


Study participants were randomly assigned to receive amantadine hydrochloride 100 mg twice daily versus equivalent placebo for 28 days .


Symptoms of irritability and aggression were measured before and after treatment using the Neuropsychiatric Inventory Irritability ( NPI-I ) and Aggression ( NPI-A ) domains , as well as the NPI-Distress for these domains


: In the amantadine group , 80.56 % improved at least 3 points on the NPI-I , compared with 44.44 % in the group that received placebo ( P = .0016 ) .


Mean change in NPI-I was -4.3 in the amantadine group and -2.6 in the placebo group ( P = .0085 ) .


When excluding individuals with minimal to no baseline aggression , mean change in NPI-A was -4.56 in the amantadine group and -2.46 in the placebo group ( P = .046 ) .


Mean changes in NPI-I and NPI-A Distress were not statistically significant between the amantadine and placebo groups .


Adverse event occurrence did not differ between the 2 groups


: Amantadine 100 mg every morning and at noon appears an effective and safe means of reducing frequency and severity of irritability and aggression among individuals with TBI and sufficient creatinine clearance .


To investigate the effect of aerobic exercise training ( AET ) and cognitive-behavioral therapy ( CBT ) on chronic fatigue in patients with facioscapulohumeral muscular dystrophy ( FSHD ) .


We performed a multicenter , assessor-blinded , randomized clinical trial ( RCT ) .


Fifty-seven patients with FSHD type 1 with severe chronic fatigue were randomly allocated to AET , CBT , or usual care ( UC ) .


Outcomes were assessed before treatment , following 16 weeks of intervention , and after a 12-week follow-up .


A linear mixed model for repeated measurements was used to study the estimated group differences .


Following treatment , both the AET ( 28 participants ) and CBT ( 25 participants ) intervention groups had less fatigue relative to the UC group ( 24 participants ) , with a difference of -9.1 for AET ( 95 % confidence interval [ CI ] -12.4 to -5.8 ) and -13.3 for CBT ( 95 % CI -16.5 to -10.2 ) .


These beneficial effects lasted through follow-up , with a difference of -8.2 for AET ( 95 % CI -12.4 to -5.8 ) and -10.2 for CBT ( 95 % CI -14.0 to -6.3 ) .


The patients who received CBT had an increase in registered and experienced physical activity , sleep quality , and social participation .


The patients who received AET had an increase in registered physical activity only .


The increase in registered physical activity in both groups and the improvement in social participation following CBT were still present at follow-up .


This RCT shows that AET and CBT can ameliorate chronic fatigue in patients with FSHD .


This study provides Class III evidence that , in patients with FSHD type 1 and severe chronic fatigue , AET or CBT reduces the severity of chronic fatigue .


To compare intraindividually two macrocyclic contrast agents - gadobutrol and gadoterate meglumine ( Gd-DOTA ) - for dynamic and quantitative assessment of relative enhancement ( RE ) in benign and malignant breast lesions .


This was an ethically approved , prospective , single-centre , randomized , crossover study in 52 women with suspected breast lesions referred for magnetic resonance imaging ( MRI ) .


Each patient underwent one examination with gadobutrol and one with Gd-DOTA ( 0.1 mmol/kg BW ) on a 1.5 T system 1 - 7 days apart .


Dynamic , T1-weighted , 3D gradient echo sequences were acquired under identical conditions .


Quantitative evaluation with at least three regions of interest ( ROI ) per lesion was performed .


Primary endpoint was RE during the initial postcontrast phase after the first and second dynamic acquisition , and peak RE .


All lesions were histologically proven ; differences between the examinations were evaluated .


Forty-five patients with a total of 11 benign and 34 malignant lesions were assessed .


Mean RE was significantly higher for gadobutrol than Gd-DOTA ( p < 0.0001 ) .


Gadobutrol showed significantly less washout ( 64.4 % ) than Gd-DOTA ( 75.4 % ) in malignant lesions ( p = 0.048 ) CONCLUSIONS : Gadobutrol has higher RE values compared with Gd-DOTA , whereas Gd-DOTA shows more marked washout in malignant lesions .


This might improve the detection of breast lesions and influence the specificity of breast MRI-imaging .


The Maastricht , Asia-Pacific consensus guidelines strongly recommend eradication of Helicobacter pylori in patients who have a history of gastric cancer .


This open-label , single-center , randomized controlled trial was conducted to investigate the appropriate timing of eradication for patients undergoing gastrectomy .


One hundred and fifty patients scheduled to undergo gastrectomy were allocated to either a preoperative or a postoperative group .


The eradication regimen was a common triple therapy : lansoprazole , amoxicillin , and clarithromycin .


Patients in the preoperative group were treated with the regimen , followed by surgery , and patients in the postoperative group were treated after postoperative day 8 .


The primary end point was the proportion of patients achieving successful eradication in the remnant stomach .


The definition of successful eradication was negativity in both the C13 urea breath test and for the antigen in feces at 6 months after surgery .


Eight patients were excluded , and the remaining one hundred and forty-two , 70 in the preoperative group and 72 in the postoperative group , were included on an intention to treat basis .


The procedures used were gastrectomy with Billroth I , Roux-en-Y , and pylorus-preserving gastrectomy in 18 , 70 , and 57 patients , respectively .


The proportion of patients showing successful eradication hardly differed between the 2 groups , 68.6 % vs 69.4 % ( p = 1.000 ) in the pre - and postoperative groups , respectively .


Subgroup analysis also demonstrated no significant difference among the reconstruction methods used .


Preoperative H pylori eradication therapy for gastric cancer patients scheduled for gastrectomy is not necessary , regardless of the planned reconstruction procedure .


Although there has been growing evidence for the efficacy of mindfulness-based cognitive therapy ( MBCT ) for different clinical populations , its effectiveness as a public mental health intervention has not been studied .


The present study evaluates a community-based MBCT intervention for adults with mild to moderate depressive symptomatology in a large multi-site , pragmatic randomized controlled trial .


The participants with mild to moderate depressive symptomatology were recruited from the general population and randomized to the MBCT intervention ( n = 76 ) or to a waiting list control group ( n = 75 ) .


Participants completed measures before and after the intervention .


Participants in the experimental condition also completed these measures at a 3-month follow-up .


In the experimental condition significant reductions in depression , anxiety , and experiential avoidance , and improvements in mindfulness and emotional - and psychological mental health were found , compared to the waiting list ( effect sizes Cohen 's d = 0.31-0 .56 ) .


These effects were sustained at the 3-month follow-up .


The likelihood of a clinically significant change in depressive symptoms was significantly higher for the MBCT group [ odds ratio ( OR ) 3.026 , p < 0.01 at post-treatment ; NNT = 5.10 ] .


MBCT as a public mental health intervention for adults with mild to moderate depressive symptoms seems effective and applicable in a natural setting .


Nederlands Trial Register NTR2096 .


To determine whether acute migraine treatment outcome is different in migraine with aura compared with migraine without aura .


We examined pooled outcome data for sumatriptan treatment of migraine with and without aura from the sumatriptan/naratriptan aggregate patient database .


We also examined similar outcome data for inhaled dihydroergotamine ( DHE ) from a single , large randomized controlled study .


The pooled pain-free rates 2 hours postdose for sumatriptan 100 mg were significantly higher in patients treating attacks without aura ( 32 % ) compared with the group who treated attacks with aura ( 24 % ) ( p < 0.001 ) .


The relative risk for pain freedom 2 hours postdose for attacks without aura was 1.33 ( 95 % confidence interval : 1.16-1 .54 ) .


The number needed to treat for 2 hours of pain freedom was 4.4 for attacks without aura and 6.2 for attacks with aura .


For the clinical trial of DHE , the 2-hour pain-free rates did not differ between patients treating attacks without aura ( 29.4 % ) compared with those who treated attacks with aura ( 27.2 % ; p = 0.65 ) .


The relative risk for pain freedom 2 hours postdose for attacks without aura vs with aura was 1.08 ( 95 % confidence interval : 0.77-1 .53 ) .


The number needed to treat for 2 hours pain free was 5.8 for attacks without aura and 5.0 for attacks with aura .


This post hoc analysis of pooled data from multiple randomized trials indicates that sumatriptan is less effective as acute therapy for migraine attacks with aura compared with attacks without aura .


In the single study of inhaled DHE , the treatment had similar efficacy for migraine attacks with and without aura .


Different responses of migraine with vs without aura to acute therapies may provide insight into underlying migraine mechanisms and influence the choice of acute therapies for different types of migraine attacks .


Adjuvanted influenza vaccines can overcome the poor antibody response of conventional non-adjuvanted vaccines in the elderly .


We evaluated the immunogenicity , safety and clinical effectiveness of an MF59 ( ) - adjuvanted trivalent influenza vaccine ( aTIV ) compared with a non-adjuvanted vaccine ( TIV ) in subjects 65 years old , with or without co-morbidities .


In 2010-2011 , subjects ( N = 7082 ) were randomized to receive one dose of aTIV or TIV .


Co-primary objectives were to assess lot-to-lot consistency of aTIV , non-inferiority , superiority and immunogenicity 22 days after vaccination .


Clinical effectiveness , reactogenicity and serious adverse events were monitored up to Day 366 .


The immunological equivalence of three lots of aTIV was demonstrated .


aTIV was not only non-inferior to TIV but also elicited significantly higher antibody responses at Day 22 than TIV against all homologous and heterologous strains , even in subjects with co-morbidities .


Superiority was not established .


Reactogenicity was higher in the aTIV group , but reactions were mild to moderate and transient .


aTIV elicited a significantly higher antibody response than TIV , especially against A/H3N2 strains , although superiority by pre-defined criteria was not formally met .


The study demonstrates potential immunological benefits of MF59-adjuvanted influenza vaccines for the elderly .


This trial was registered with www.clinicaltrials.gov ( NCT01162122 ) .


Enhancing physical activity in overweight and obese individuals is an important means to promote health in this target population .


The Health Action Process Approach ( HAPA ) , which was the theoretical framework of this study , focuses on individual self-regulation variables for successful health behavior change .


One key self-regulation variable of this model is action control with its three subfacets awareness of intentions , self-monitoring and regulatory effort .


The social context of individuals , however , is usually neglected in common health behavior change theories .


In order to integrate social influences into the HAPA , this randomized controlled trial investigated the effectiveness of a dyadic conceptualization of action control for promoting physical activity .


This protocol describes the design of a single-blind randomized controlled trial , which comprises four experimental groups : a dyadic action control group , an individual action control group and two control groups .


Participants of this study are overweight or obese , heterosexual adult couples who intend to increase their physical activity .


Blocking as means of a gender-balanced randomization is used to allocate couples to conditions and partners to either being the target person of the intervention or to the partner condition .


The ecological momentary intervention takes place in the first 14 days after baseline assessment and is followed by another 14 days diary phase without intervention .


Follow-ups are one month and six months later .


Subsequent to the six-months follow-up another 14 days diary phase takes place.The main outcome measures are self-reported and accelerometer-assessed physical activity .


Secondary outcome measures are Body Mass Index ( BMI ) , aerobic fitness and habitual physical activity .


This is the first study examining a dyadic action control intervention in comparison to an individual action control condition and two control groups applying a single-blind randomized control trial .


Challenges with running couples studies as well as advantages and disadvantages of certain design-related decisions are discussed .


This RCT was funded by the Swiss National Science Foundation ( PP00P1_133632 / 1 ) and was registered on 27/04/2012 at http://www.isrctn.com/ISRCTN15705531 .


We sought to examine changes in intraocular pressure ( IOP ) in the immediate period after clear corneal micro-incision cataract surgery ( MICS ) and after small-incision cataract surgery ( SICS ) .


Sixty-eight eyes of 34 patients scheduled for coaxial phacoemulsification were randomized into one of two groups : ( a ) eyes that were to undergo a 2.0-mm MICS , and ( b ) a 2.65-mm SICS .


At the conclusion of surgery , the IOP was adjusted to the range between 15-40mmHg with stromal hydration .


The IOP was measured using a rebound tonometer preoperatively , at the conclusion of surgery , and at 3 , 6 , 9 , 12 , and 15min postoperatively .


The Seidel test and anterior segment-optical coherence tomography were performed at 20min postoperatively .


Mean IOP at the conclusion of surgery was 27.74.7 mmHg in the MICS group and 29.75.1 mmHg in the SICS group ( p = 0.1239 ) .


In both groups , mean IOP decreased to the preoperative level within 9min postoperatively and did not change significantly for up to 15min .


Mean IOP was similar between the MICS and SICS groups throughout the observation period ( p0 .1239 ) .


Hypotony ( 10mmHg ) , positive Seidel test , and loss of wound coaptation were not detected in all eyes .


After adjusting the IOP to a relatively high level at the conclusion of surgery , the IOP decreased within 9min and was stable within 15min without hypotony .


The IOP was comparable between eyes after MICS and SICS , and both incisions virtually closed within 20min postoperatively .


Buprenorphine/naloxone ( BUP/NX ) , an effective treatment for opioid dependence , has been implicated in hepatic toxicity .


However , as persons taking BUP/NX have multiple hepatic risk factors , comparative data are needed to quantify the risk of hepatoxicity with BUP/NX .


We compared rates of alanine aminotransferase ( ALT ) elevationgrade 3 ( ALT5 .1 times the upper limit of normal ) and graded bilirubin elevations in HIV-negative opioid injectors randomized to long-term ( 52 weeks ) or short-term ( 18 days ) medication assisted treatment ( LT-MAT and ST-MAT , respectively ) with BUP/NX in a multisite trial conducted in China and Thailand .


ALT and bilirubin were measured at baseline , 12 , 26 , 40 and 52 weeks , times temporally remote from BUP/NX exposure in the ST-MAT participants .


Among1036 subjects with at least one laboratory follow-up measurement , 76 ( 7 % ) participants experienced ALT elevationgrade 3 .


In an intent-to-treat analysis , the risk of ALT events was similar in participants randomized to LT-MAT compared with ST-MAT ( adjusted hazard ratio 1.25 , 95 % confidence interval 0.79 to 1.98 ) .


This finding was supported by an as-treated analysis , in which actual exposure to BUP/NX was considered .


Hepatitis C seroconversion during follow-up was strongly associated with ALT events .


Bilirubin elevationsgrade 2 occurred in 2 % of subjects , with no significant difference between arms .


Over 52-week follow-up , the risk of hepatotoxicity was similar in opioid injectors receiving brief and prolonged treatment with BUP/NX .


These data suggest that most hepatotoxic events observed during treatment with BUP/NX are due to other factors .


Patients with type 1 diabetes face heightened risk of hypoglycemia after exercise .


Subsequent overfeeding , as a preventative measure against hypoglycemia , negates the energy deficit after exercise .


Patients are also required to reduce the insulin dose administered with postexercise foods to further combat hypoglycemia .


However , the insulin dose is dictated solely by the carbohydrate content , even though postprandial glycemia is vastly influenced by glycemic index ( GI ) .


With a need to control the postexercise energy balance , appetite responses after meals differing in GI are of particular interest .


We assessed the appetite response to low-glycemic index ( LGI ) and high-glycemic index ( HGI ) postexercise meals in type 1 diabetes patients .


This assessment also offered us the opportunity to evaluate the influence of GI on appetite responses independently of insulinemia , which confounds findings in individuals without diabetes .


Ten physically active men with type 1 diabetes completed 2 trials in a randomized crossover design .


After 45 min of treadmill exercise at 70 % of the peak oxygen uptake , participants consumed an LGI ( GI 37 ) or HGI ( GI 92 ) meal with a matched macronutrient composition , negligible fiber content , and standardized insulin-dose administration .


The postprandial appetite response was determined for 180 min postmeal .


During this time , circulating glucose , insulin , glucagon , and glucagon-like peptide-1 ( GLP-1 ) concentrations and subjective appetite ratings were determined .


The HGI meal produced an 60 % greater postprandial glucose area under the curve ( AUC ) than did the LGI meal ( P = 0.008 ) .


Insulin , glucagon , and GLP-1 did not significantly differ between trials ( P > 0.05 ) .


The fullness AUC was 25 % greater after the HGI meal than after the LGI meal ( P < 0.001 ) , whereas hunger sensations were 9 % lower after the HGI meal than after the LGI meal ( P = 0.001 ) .


Under conditions of matched insulinemia and fiber , an HGI postexercise meal suppresses feelings of hunger and augments postprandial fullness sensations more so than an otherwise equivalent LGI meal in type 1 diabetes patients .


This study sought to evaluate the prognostic value of routine stress myocardial perfusion scintigraphy ( MPS ) 5 years after percutaneous coronary intervention ( PCI ) .


Current appropriate use criteria define routine cardiac stress imaging < 2 years after PCI as inappropriate and > 2 years as uncertain in asymptomatic patients .


All 339 of 683 BASKET ( Basel Stent Kosteneffektivitts Trial ) 5-year survivors ( 55 % ) consenting to undergo protocol-mandated MPS and subsequent evaluation irrespective of symptoms were followed for major adverse cardiac events ( MACE ) ( cardiac death , myocardial infarction [ MI ] , or revascularization ) .


For MPS , summed perfusion scores were calculated and perfusion defects were related to treated-vessel or remote myocardial areas .


Patients were 72 10 years of age , 18 % were female , and 90 % were free of angina .


MPS findings were abnormal in 205 of 339 patients ( 60 % ) with complete follow-up .


During 3.7 0.3 years , there were 7 cardiac deaths , 18 MIs , and 47 revascularizations , resulting in a MACE rate of 4.4 % and a cardiac mortality rate of 0.6 % per year .


Patients with abnormal MPS findings had higher hazard ratios ( HR ) for MACE ( HR : 1.95 ; 95 % confidence interval [ CI ] : 1.06 to 3.59 ; p = 0.032 ) , and cardiac death/MI ( HR : 2.50 ; 95 % CI : 0.93 to 6.69 ; p = 0.066 ) than patients with normal MPS finding .


MACE rates were similar in patients with symptomatic and silent ischemia ( p = 0.61 ) but higher than in patients with normal MPS findings ( p < 0.05 for both comparisons ) .


MACE rates were independently predicted by remote ischemia but not by treated-vessel ischemia or scar .


Abnormal MPS findings 5 years after PCI are frequent irrespective of symptoms .


The predictive power of abnormal MPS lies more in the detection of persistent or progressing coronary artery disease in remote vessel areas than in the diagnosis of late intervention-related problems in treated vessels .


Patients with posttraumatic stress disorder ( PTSD ) have significant medical morbidity , which may be mediated by hypothalamic pituitary axis ( HPA ) dysfunction and reflected in cortisol output .


Many veterans with PTSD are hesitant to engage in trauma-focused exposure treatments ; therefore briefer , non-exposure-based treatments are needed ; one such promising approach is an abbreviated Primary Care brief Mindfulness Program ( PCbMP ) .


This study investigated the relationship between dose-response to participation in a veterans PCbMP program and diurnal cortisol .


Cortisol reflects HPA function and PTSD is associated with HPA dysregulation .


Veterans with PTSD were identified in PC and randomly assigned to treatment as usual ( TAU , n = 21 ) or participation in brief 4-week Mindfulness Based Stress Reduction program ( n = 19 ) .


Veterans ( n = 40 ) ( mean age , 4816 y ; 90 % men ) with PTSD referred through their VA PC provider and randomly assigned to PCbMP or TAU .


As an objective indicator of HPA function , salivary diurnal cortisol was measured from samples collected across 2 consecutive days at baseline and follow-up .


Analyses revealed that significant changes in cortisol were associated with PCbMP treatment engagement and dosing ( number of mindfulness program sessions completed ) .


Veterans completing 4 mindfulness-based meditation sessions significantly reduced their cortisol awakening response ( P0 .05 ) ; and had significant changes in cortisol area under the curve increase compared with TAU participants ( P0 .05 ) .


Results indicate that PCbMP has a beneficial physiological impact on veterans with PTSD with a minimum of 4 weeks of practice .


To compare intraocular pressure ( IOP ) measurements with the Goldmann applanation tonometer ( GAT ) and the ICare rebound tonometer ( RBT ) in high myopic eyes .


This randomized prospective study included 40 eyes of 40 patients with high myopia .


All patients ' central corneal thickness ( CCT ) , anterior chamber depth ( ACD ) , axial length ( AXL ) , keratometry , and refractive measurements were recorded and followed by IOP measurement with RBT and GAT .


The average CCT , AXL , and ACD were determined to be 514.65 32 m , 27.65 2.22 mm , and 3.25 0.51 mm , respectively .


Mean K was 43.27 1.4 D and mean spherical equivalent was -11.31 4.30 D.


The mean IOP values obtained by RBT and GAT were 17.18 3.72 mmHg and 16.48 3.19 mmHg , respectively .


The deviations of RBT readings from corrected GAT values were highly correlated with CCT values ( r = 0.588 , P = 0.0001 ) .


The mean corrected GAT reading was 17.49 3.01 mmHg .


Linear regression analysis showed that a CCT change of 10 m resulted in an RBT reading deviation of 0.57 mmHg .


The Bland-Altman scatter-plot and McNemar test showed a clinically good level of agreement between the two tonometers .


This study found a good agreement level between the two tonometers in high myopic patients and that RBT measurements are influenced by CCT variations .


To explore the clinical effectiveness of continuous blood purification ( CBP ) in combination with ulinastatin for the treatment of thermoplegia .


Forty patients ( 28 men and 12 women ) with severe heat stroke were admitted to our hospital 's ICU department from June 2010 to August 2013 .


The patients were randomized into a treatment group ( n = 21 ; 15 men and six women , with an average age of 32.9 years ) and control group ( n = 19 ; 13 men and six women , with an average age of 33.1 years ) .


Patients in the control group underwent treatments of oxygen inhalation , dynamic ECG monitoring , physical cooling methods ( ice caps or ice application ) , whereas patients in the treatment group , in addition to this treatment , were further treated with continuous blood purification in combination with ulinastatin .


During administration , the content of one vial was dissolved in 100 mL of physiological saline for intravenous dripping for 1.5 hours .


There were 18 cured cases , one case of sequelae of mild neurological disorders , and two deaths in the treatment group , with the cure rate of 90.48 % .


In comparison , there were 12 cured cases , three cases of sequelae of mild neurological disorders , and four deaths in the control group , with the cure rate of 78.95 % .


The overall response rates of rectal temperature drop were determined to be 95.24 % and 73.68 % for the treatment group and the control group , respectively .


Based on the treatment outcomes data , multiple organ dysfunction syndrome ( MODS ) recovery , deaths and survival outcomes of patients in the treatment group was more favorable than that of the control group .


This difference was statistically significant ( p < 0.05 ) .


Continuous blood purification in combination with ulinastatin is effective in treating thermoplegia and warrants further investigation .


The potential for telehealth-based interventions to provide remote support , education and improve self-management for long-term conditions is increasingly recognised .


This trial aims to determine whether an intervention delivered through an easy-to-use tablet computer can improve the quality of life of patients with chronic obstructive pulmonary disease ( COPD ) by providing personalised self-management information and education .


The EDGE ( sElf management anD support proGrammE ) for COPD is a multicentre , randomised controlled trial designed to assess the efficacy of an Internet-linked tablet computer-based intervention ( the EDGE platform ) in improving quality of life in patients with moderate to very severe COPD compared with usual care .


Eligible patients are randomly allocated to receive the tablet computer-based intervention or usual care in a 2:1 ratio using a web-based randomisation system .


Participants are recruited from respiratory outpatient clinics and pulmonary rehabilitation courses as well as from those recently discharged from hospital with a COPD-related admission and from primary care clinics .


Participants allocated to the tablet computer-based intervention complete a daily symptom diary and record clinical symptoms using a Bluetooth-linked pulse oximeter .


Participants allocated to receive usual care are provided with all the information given to those allocated to the intervention but without the use of the tablet computer or the facility to monitor their symptoms or physiological variables .


The primary outcome of quality of life is measured using the St George 's Respiratory Questionnaire for COPD patients ( SGRQ-C ) baseline , 6 and 12 months .


Secondary outcome measures are recorded at these intervals in addition to 3 months .


The Research Ethics Committee for Berkshire-South Central has provided ethical approval for the conduct of the study in the recruiting regions .


The results of the study will be disseminated through peer review publications and conference presentations .


Current controlled trials ISRCTN40367841 .


To evaluate the efficacy and safety of human glucagon-like peptide-1 analogue liraglutide in newly diagnosed type 2 diabetes mellitus ( T2DM ) with glycosylated hemoglobin A1c ( HbA1c ) > 9 % .


This was an open-labelled , randomized , parallel-group , treat-to-target trial .


Newly diagnosed T2DM patients with HbA1c > 9 % were enrolled .


These patients were treated with metformin with repaglinide and randomized to receive once-daily liraglutide ( LIRA , n = 25 ) or the insulin glargine ( IGla , n = 24 ) at bedtime .


Efficacy and safety were assessed and compared after 18-month treatment .


( 1 ) Compared with the baseline , patients with LIRA had significantly reduced mean body weight , BMI and waist circumference ( P < 0.01 ) , whereas , the above indexes were increased ( P < 0.01 ) in patients treated with IGla .


( 2 ) After 18 months of treatment , fasting plasma glucose ( FPG ) , 2-hour plasma glucose after a 75g oral glucose load ( 2hPG ) and HbA1c were significantly improved in all patients ( P < 0.01 ) , with 2hPG , mean blood glucose ( MBG ) , the largest amplitude of glycemic excursions ( LAGE ) , mean amplitude of glycemic excursions ( MAGE ) were significantly lower in LIRA group than in IGla group ( all P < 0.05 ) .


( 3 ) HOMA-IR decreased in both groups ( P < 0.05 ) .


However , I30/G30 , AUCCP180 and Matsuda index were only significantly increased in patients treated with LIRA ( respectively , 4.88 1.55 vs 7.601.91 , 9.23 2.66 vs 13.18 2.72 , 39.28 20.35 vs 54.64 23.34 , all P < 0.01 ) , while HOMA-IR reduced ( 4.41 1.58 vs 3.52 1.44 , P < 0.05 ) .


But in IGla group only HOMA-IR was reduced ( 4.92 1.84 vs 4.57 1.80 , P < 0.05 ) .


The index of I30/G30 , AUCCP180 and Matsuda index in LIRA group are higher than those of indexes in IGla group ( respectively , 7.60 1.91 vs 4.18 1.00 , 13.18 2.72 vs 10.53 2.68,54.64 23.34 vs 41.65 17.84 , all P < 0.05 ) , while HOMA-IR is lower ( 3.52 1.44 vs 4.57 1.80 , P < 0.05 ) .


( 4 ) The rate of HbA1c 6.5 % and the dosages of oral anti-diabetic drugs in LIRA group were significantly better than that in IGla group .


( 5 ) No significant differences were observed in hypoglycemic episodes and adverse events between two groups .


It seems that liraglutide is superior to insulin glargine in newly diagnosed T2DM patients with HbA1c > 9 % in improving beta-cell function , insulin sensitivity and glucose homeostasis .


This primary objective of this pilot randomized , controlled trial was to determine whether a brief video intervention delivered after a pediatric office visit could improve inhaler technique in children with asthma immediately and one month later .


The intervention 's effect on children 's inhaler self-efficacy and asthma control was also evaluated .


Children ( n = 91 ) ages 7-17 years with persistent asthma were recruited at two pediatric practices in North Carolina .


Eligible children demonstrated their inhaler technique for metered dose inhalers ( MDIs ) either with or without a spacer .


A trained research assistant used a validated inhaler technique checklist to record which steps children performed correctly .


After a regularly scheduled office visit , children were randomized to watch either a 3-min MDI video ( intervention group ) or a nutrition video ( control group ) in English or Spanish .