Qualitative data indicated that 49 of 61 Bite Back users ( 79 % ) reported positive experiences using the website and 55 ( 89 % ) agreed they would continue to use it after study completion .


Compared to the control condition , participants in the Bite Back condition with high levels of adherence ( usage of the website for 30 minutes or more per week ) reported significant decreases in depression and stress and improvements in well-being .


Bite Back users who visited the site more frequently ( 3 times per week ) reported significant decreases in depression and anxiety and improvements in well-being .


No significant improvements were found among Bite Back users who demonstrated low levels of adherence or who used the website less frequently .


Results suggest that using an online positive psychology program can decrease symptoms of psychopathology and increase well-being in young people , especially for those who use the website for 30 minutes or longer per week or more frequently ( 3 times per week ) .


Acceptability of the Bite Back website was high .


These findings are encouraging and suggest that the online delivery of positive psychology programs may be an alternate way to address mental health issues and improve youth well-being nationally .


Australian New Zealand Clinical Trials Registry : ACTRN1261200057831 ; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362489 ( Archived by Webcite at http://www.webcitation.org/6NXmjwfAy ) .


This open-label , prospective , observational study aimed to evaluate treatment response , efficacy therapy and safety to IFN -2 b for the essential thrombocythemia ( ET ) and polycythemia vera ( PV ) with JAK2V617F positive mutation .


A total of 123 ET patients received IFN-2b therapy with JAK2V617F positive or negative mutation ; and 136 PV patients with JAK2V617F ( + ) received IFN-2b or hydroxyurea ( HU ) therapy according to random number assignment ( ages 18-65 years old ) .


ET patients receiving IFN -2 b with JAK2V617F ( + ) had a greater advantage in overall hematologic response ( OHR ) than JAK2V617F ( - ) ( 83.3 % versus 61.4 % , P < 0.01 ) .


For PV patients with JAK2V617F ( + ) , IFN had no OHR superiority to HU ( 70.3 % versus 70.8 % , P > 0.05 ) , but which gained a greater satisfactory molecular response than HU ( 54.7 % versus 19.4 % , P < 0.01 ) .


IFN significantly decreased the phlebotomy rate , which was better than HU for MPDs patients with OHR than HU ( 3.6 % versus 65.7 % , P < 0.01 ) .


Furthermore , ET patients with JAK2V617F ( + ) demonstrated a definite advantage over JAK2V617F ( - ) in five-year PFS ( 75.9 % versus 47.6 % , P < 0.05 ) .


For PV patients with JAK2V617F ( + ) , IFN -2 b was superior to HU in five-year PFS ( 66.3 % versus 46.7 % , P < 0.01 ) .


Moreover , IFN -2 b also contributed to improved vasomotor symptoms in MPDs , and especially significantly decreased the incidence of distal paresthesias ( 14.1 % versus 37.5 % ) and erythromelalgia ( 9.4 % versus 29.2 % ) better than HU ( P < 0.01 ) .


Meanwhile , IFN did not observe the severe hematological adverse events in patients with PV or ET .


The data confirmed that IFN -2 b benefited the patients with ET or PV , particularly for JAK2V617F ( + ) mutation .


The inflammatory response in patients with seasonal allergic rhinitis ( SAR ) is partly mediated by the prostaglandin D2 receptor chemoattractant receptor homologous molecule on T ( H ) 2 cells ( CRTH2 ) .


We sought to investigate the efficacy and safety of the oral CRTH2 antagonist BI 671800 ( 50 , 200 , and 400 mg twice daily ) , fluticasone propionate nasal spray ( 200 g once daily ) , or oral montelukast ( 10 mg once daily ) administered for 2 weeks in patients with SAR .


In this randomized , double-blind , placebo-controlled , partial-crossover study , participants aged 18 to 65 years with a positive skin prick test to Dactylis glomerata pollen were exposed to out-of-season allergen in the environmental challenge chamber for 6 hours .


The primary efficacy variable was the total nasal symptom score assessed as the area under the curve ( AUC ) ( 0-6h ) .


In total , 146 patients ( 63.7 % male ; mean age , 36.1 years ) were randomized .


The adjusted mean total nasal symptom score AUC ( 0-6h ) was significantly reduced versus placebo with 200 mg of BI 671800 ( absolute difference , -0.85 ; percentage difference , -17 % ; P = .0026 ) , montelukast ( absolute difference , -0.74 ; percentage difference , -15 % ; P = .0115 ) , and fluticasone propionate ( absolute difference , -1.64 ; percentage difference , -33 % ; P < .0001 ) .


Compared with placebo , BI 671800 significantly reduced nasal eosinophil values ( P < .05 for all doses ) , significantly inhibited nasal inflammatory cytokine levels ( IL-4 and eotaxin , P < .05 ; 200 mg twice daily ) , and induced a dose-related reduction in ex vivo prostaglandin D2-mediated eosinophil shape change .


Two hundred milligrams of BI 671800 twice daily demonstrated efficacy in treating SAR symptoms induced by environmental challenge chamber allergen exposure and had a favorable safety profile .


The effects of an oral hygienic care program ( OHCP ) have been reported in several diseases .


However , no study exists investigating the influence of an OHCP on stroke patients or patients in the intensive care unit ( ICU ) has been reported , thus we sought to investigate the potential effect of an OHCP .


Fifty-six consecutive stroke patients who were admitted to the ICU were randomly assigned to two groups : the intervention ( 29 patients ) and control groups ( 27 patients ) .


The OHCP included tooth brushing with an inter-dental brush and tongue cleaner and cleaning with chlorhexidine was administered to patients by one dentist once per day during admission in the ICU ( mean , 2.2 weeks ) .


The plague index , gingival index , clinical attachment loss , and colonization degree of candida albicans were assessed .


After OHCP , the plaque index , gingival index , and colonization degree of candida albicans in saliva showed a significant decrease in the intervention group compared to those of the control group ( p < 0.05 ) .


However , no significant difference was observed in clinical attachment loss and the colonization degree of candida albicans on the tongue ( p > 0.05 ) .


Our OHCP was effective in improving the oral hygienic status and periodontal health of stroke patients during their stay in the ICU .


Therefore , we recommend administration of the OHCP for stroke patients during their stay in the ICU .


There are limited data on the performance of narrow band imaging ( NBI ) and Fujinon intelligent color enhancement ( FICE ) for differentiating polyp histologies .


The aim of this study was to compare the diagnostic performances of NBI and FICE in differentiating neoplastic from non-neoplastic colorectal polyps < 10 mm during screening colonoscopy .


A total of 955 average-risk adults undergoing screening colonoscopies were randomly allocated to NBI or FICE groups .


Four board-certified staff endoscopists without prior experience using NBI or FICE participated .


The main outcomes of this study were overall accuracy , sensitivity , and specificity of FICE and NBI in identifying neoplastic polyps .


There was no significant difference in the number of subjects with adenoma between the NBI ( 143/475 , 30.1 % ) and FICE groups ( 139/480 , 29.0 % ) ( after excluding adenoma 1 cm ) ( P > 0.05 ) .


The overall accuracy of NBI was 81.0 % , compared with 81.4 % for FICE ( P = 0.867 ) .


The overall sensitivity and specificity of NBI and FICE were 84.6 and 78.0 % ( P = 0.054 ) ; 75.1 and 86.5 % ( P = 0.009 ) , respectively .


For polyps measuring 5 mm , the accuracy was 79.4 % for NBI and 80.1 % for FICE ( P = 0.835 ; sensitivity 81.9 vs. 74.5 % , P = 0.064 ; specificity 75.7 vs. 88.4 % , P = 0.006 ) .


The overall accuracy of NBI and FICE was similar for differentiating small polyp histologies during screening colonoscopy .


However , better results should be achieved before using NBI or FICE as real-time optical biopsy of colorectal polyps in screening colonoscopy .


The Placement of Aortic Transcatheter Valves ( PARTNER ) trial demonstrated similar survival after transcatheter and surgical aortic valve replacement ( TAVR and SAVR , respectively ) in high-risk patients with symptomatic , severe aortic stenosis .


The aim of this study was to evaluate the effect of left ventricular ( LV ) dysfunction on clinical outcomes after TAVR and SAVR and the impact of aortic valve replacement technique on LV function .


The PARTNER trial randomized high-risk patients with severe aortic stenosis to TAVR or SAVR .


Patients were stratified by the presence of LV ejection fraction ( LVEF ) < 50 % .


All-cause mortality was similar for TAVR and SAVR at 30-days and 1 year regardless of baseline LV function and valve replacement technique .


In patients with LV dysfunction , mean LVEF increased from 35.78.5 % to 48.611.3 % ( P < 0.0001 ) 1 year after TAVR and from 38.08.0 % to 50.110.8 % after SAVR ( P < 0.0001 ) .


Higher baseline LVEF ( odds ratio , 0.90 [ 95 % confidence interval , 0.86 , 0.95 ] ; P < 0.0001 ) and previous permanent pacemaker ( odds ratio , 0.34 [ 95 % confidence interval , 0.15 , 0.81 ] ) were independently associated with reduced likelihood of 10 % absolute LVEF improvement by 30 days ; higher mean aortic valve gradient was associated with increased odds of LVEF improvement ( odds ratio , 1.04 per 1 mm Hg [ 95 % confidence interval , 1.01 , 1.08 ] ) .


Failure to improve LVEF by 30 days was associated with adverse 1-year outcomes after TAVR but not SAVR .


In high-risk patients with severe aortic stenosis and LV dysfunction , mortality rates and LV functional recovery were comparable between valve replacement techniques .


TAVR is a feasible alternative for patients with symptomatic severe aortic stenosis and LV dysfunction who are at high risk for SAVR .


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


Unique identifier : NCT00530894 .


To investigate the effects of nursing care based on the Theory of Human Caring on distress caused by infertility , perceived self-efficacy and adjustment levels .


Infertility leads to individual , familial and social problems .


Nursing care standards for women affected by infertility have yet to emerge .


A randomized controlled trial .


This study was conducted from May 2010-February 2011 , with 105 Turkish women with infertility ( intervention group : 52 , control group : 53 ) .


We collected data using the Infertility Distress Scale , the Turkish-Infertility Self Efficacy Scale Short Form and the Turkish-Fertility Adjustment Scale .


The intervention group received nursing care based on the Theory of Human Caring .


Data were analysed using t-tests , chi-square tests and intention-to-treat analyses .


The intervention and control groups significantly differed with regard to infertility distress , self-efficacy and adjustment levels .


The intervention group 's mean self-efficacy score increased by seven points and adjustment score decreased by seven points ( in a positive direction ) .


In addition , there was a significant reduction in infertility distress scores in the intervention group , but there was no change in the control group .


Nursing care based on the Theory of Human Caring decreased the negative impact of infertility in women receiving infertility treatment and increased self-efficacy and adjustment .


Allergic rhinitis ( AR ) affects up to 30 % of the adult population and symptomatic patients continue to engage in daily life activities , including car driving .


Previous studies have shown that AR can impair cognitive functions , especially during longer-lasting tasks .


Other reports suggest negative effects on psychomotor functions such as driving , but no clear evidence has been presented yet .


Primary objective was to determine the effect of AR per se on actual driving performance and compare it with the effects of treated AR .


Nineteen patients with documented AR history underwent a unique and validated 1-h on-the-road driving test outside the pollen season .


In a 4-leg repeated measures design , patients underwent a nasal provocation test with either pollen or inactive control prior to the driving test .


In the three conditions with pollen provocation , patients were pretreated with either cetirizine 10mg , fluticasone furoate 27.5 g , or placebo to alleviate the provoked AR symptoms .


The driving performance of patients when symptomatic and not treated was significantly impaired compared to the placebo condition .


When engaging in a secondary memory task during driving , their performance deteriorated further .


The magnitude of impairment was relevant and comparable to that seen at a blood alcohol level of 0.05 % , the legal limit in many countries .


Treatment of AR symptoms partially counteracted the effect of AR on driving .


Untreated AR can impair driving ability and put patients at risk .


Drug therapy reduces this impairment , and AR patients should therefore be advised to always treat their condition .


Depression is common in primary care and is often unrecognized and untreated .


Studies are needed to demonstrate the feasibility of implementing evidence-based depression care provided by primary health care workers ( PHCWs ) in sub-Saharan Africa .


We carried out a pilot two-parallel arm cluster randomized controlled trial of a package of care for depression in primary care .


Six primary health care centers ( PHCC ) in two Local Government Areas of Oyo State , South West Nigeria were randomized into 3 intervention and 3 control clinics .


Three PHCWs were selected for training from each of the participating clinics .


The PHCWs from the intervention clinics were trained to deliver a manualized multicomponent stepped care intervention package for depression consisting of psychoeducation , activity scheduling , problem solving treatment and medication for severe depression .


Providers from the control clinics delivered care as usual , enhanced by a refresher training on depression diagnosis and management .


Outcome measures Patient 's Health Questionnaire ( PHQ-9 ) , WHO quality of Life instrument ( WHOQOL-Bref ) and the WHO disability assessment schedule ( WHODAS ) were administered in the participants ' home at baseline , 3 and 6months .


About 98 % of the consecutive attendees to the clinics agreed to have the screening interview .


Of those screened , 284 ( 22.7 % ) were positive ( PHQ-9 score8 ) and 234 gave consent for inclusion in the study : 165 from intervention and 69 from control clinics .


The rates of eligible and consenting participants were similar in the control and intervention arms .


In all 85.9 % ( 92.8 % in intervention and 83 % in control ) of the participants were successfully administered outcome assessments at 6months .


The PHCWs had little difficulty in delivering the intervention package .


At 6months follow up , depression symptoms had improved in 73.0 % from the intervention arm compared to 51.6 % control .


Compared to the mean scores at baseline , there was improvement in the mean scores on all outcome measures in both arms at six months .


The results provide support for the feasibility of conducting a fully-powered randomized study in this setting and suggest that the instruments used may have the potential to detect differences between the arms .


ISRCTN46754188 ( ISRTCN registry at isrtcn.com ) ; registered 23 September 2013 , details of the pilot study added 12/02/2015 .


To compare the effectiveness and safety of two cervical ripening methods in term primiparous women with unfavorable cervices and oligohydramnios .


Women ( 126 cases ) with oligohydramnios [ amniotic fluid index ( AFI ) 5cm ] and a low Bishop Score ( 6 ) were assigned randomly to use double balloon catheter ( mechanical method group , 67 cases ) or dinoprostone 10mg controlled-release vaginal insert ( pharmacological method group , 59 cases ) for induction of labor .


The study 's primary outcome was caesarean section rate ( CSR ) .


The secondary outcome measures included maternal and neonatal morbidity , an incremental changes in Bishop Score , and intrapartum interventions .


There was no significant difference between the mechanical method group and the pharmacological method group in CSR and change in Bishop Score .


Tacysystole , non-reassuring fetal heart patterns , and cases of newborn umbilical-cord arterial blood pH < 7.1 were significantly lower with the mechanical method compared with the pharmacological method ( p < 0.05 ) .


More patients needed additional intervention in the mechanical method group .


Both methods resulted in a similar CSR .


Double balloon catheter resulted in fewer labor complications , but more frequent use of oxytocin and amniotomy .


Compared with dinoprostone vaginal insert , double balloon catheter use may be less problematic in women with oligohydramnios .


To determine if sarcopenia modulates the response to a physical activity intervention in functionally limited older adults .


Secondary analysis of a randomized controlled trial .


Three academic centers .


Elders aged 70 to 89 years at risk for mobility disability who underwent dual-energy x-ray absorptiometry ( DXA ) for body composition at enrollment and follow-up at twelve months ( N = 177 ) .


Subjects participated in a physical activity program ( PA ) featuring aerobic , strength , balance , and flexibility training , or a successful aging ( SA ) educational program about healthy aging .


Sarcopenia as determined by measuring appendicular lean mass and adjusting for height and total body fat mass ( residuals method ) , Short Physical Performance Battery score ( SPPB ) , and gait speed determined on 400 meter course .


At twelve months , sarcopenic and non-sarcopenic subjects in PA tended to have higher mean SPPB scores ( 8.70.5 and 8.70.2 points ) compared to sarcopenic and non-sarcopenic subjects in SA ( 8.30.5 and 8.40.2 points , p = 0.24 and 0.10 ) , although the differences were not statistically significant .


At twelve months , faster mean gait speeds were observed in PA : 0.930.4 and 0.950.03 meters/second in sarcopenic and non-sarcopenic PA subjects , and 0.890.4 and 0.910.03 meters/second in sarcopenic and non-sarcopenic SA subjects ( p = 0.98 and 0.26 ) , although not statistically significant .


There was no difference between the sarcopenic and non-sarcopenic groups in intervention adherence or number of adverse events .


These data suggest that older adults with sarcopenia , who represent a vulnerable segment of the elder population , are capable of improvements in physical performance after a physical activity intervention .


Selegiline ( l-deprenyl ) is a selective monoamine oxidase type B inhibitor that has been shown to have neurotrophic and anti-apoptotic properties and to protect neurons in different experimental models of cerebral ischaemia .


The aim of this explorative study was to investigate whether selegiline could enhance cognitive and functional recovery in stroke survivors .


This was a randomized controlled study in which patients enrolled within two weeks of stroke underwent a clinical and functional evaluation and a neuropsychological assessment .


The patients were given selegiline ( 10mg/day ) or matched placebo once a day for six weeks in addition to standard rehabilitation care .


Of 137 stroke survivors , 47 patients met the inclusion criteria and were randomly assigned to the Study Group ( n = 23 ) or the Control Group ( n = 24 ) .


The statistical analysis showed a significant improvement in most neuropsychological tests after two and six weeks in the study group ; these improvements were not replicated in the control group .


The between-group analysis revealed that the domains of attention and executive functions benefited most from the drug treatment .


With regard to functional status , comparison of clinical scores at admission and discharge showed a statistically significant enhancement in both groups without statistically significant differences between the groups .


These preliminary results suggest that selegiline administered in the subacute phase can promote cognitive functioning in stroke patients .


Further studies will elucidate whether and how this enhancement can impact on functional recovery in the short and in the long term .


Covalent immobilization of antimicrobial peptide melimine onto contact lenses can produce broad-spectrum antimicrobial lenses .


The purpose of this study was to investigate the performance of melimine-coated contact lenses in an animal model and human clinical trial .


Melimine was covalently attached onto the surface of contact lenses via EDC ( 1-ethyl-3 - [ 3-dimethylaminopropyl ] carbodiimide hydrochloride ) coupling .


A rabbit model of daily contralateral wear of lenses for 22 days was conducted to assess the lens safety .


A prospective , randomized , double-masked , one-day human clinical trial was used to evaluate subjective responses and ocular physiology during contralateral wear of melimine-coated ( test ) and uncoated ( control ) lenses .


Delayed reactions were monitored during follow-up visits after 1 and 4 weeks .


Ex vivo retention of antimicrobial activity of worn lenses was assessed by reduction in numbers of viable Pseudomonas aeruginosa and Staphylococcus aureus .


Melimine-coated lenses produced no ocular signs or symptoms that would indicate cytotoxicity during the lens wear of rabbits .


No histological changes were found in rabbit corneas .


During the human trial , no differences were observed in wettability , surface deposition , lens-fitting centration , movement , tightness , and corneal coverage between test and control lenses ( p > 0.05 ) .


There were no significant differences in bulbar , limbal , or palpebral redness or conjunctival staining ( p > 0.05 ) .


Mean corneal ( extent , depth , and type ) staining was higher for test lenses compared with that for control lenses ( p < 0.05 ) .


There was no significant difference in subjective responses for lens comfort , dryness , and awareness ( p > 0.05 ) .


No delayed reactions were associated with the test lenses .


Worn test lenses retained more than 1.5 log inhibition against both bacterial types .


Melimine-coated contact lenses were worn safely by humans .


However , they were associated with higher corneal staining .


The melimine-coated lenses retained high antibacterial activity after wear .


Postoperative sore throat ( POST ) is a frequent complication caused by mucosal trauma to the pharyngeal , laryngeal , and tracheal airway after endotracheal intubation .


We compared the effectiveness of Siccoral , Strefen , and Stomatovis treatments in alleviating POST .


This prospective , randomized , single-blinded , controlled trial compares the incidence of POST with Strefen lozenges , Siccoral spray , or Stomatovis gargle .


Three hundred and twenty American Society of Anesthesiologists class I-III patients undergoing elective genitourinary surgery under general orotracheal anesthesia were randomly allocated to four groups of 80 patients each .


In the postoperative awakening unit and during related services , POST was evaluated by a blinded anesthesiologist at 0 , 1 , 6 , and 24 h post extubation .


The highest incidence of POST occured at 0 and 1 h post extubation in all groups ( P = 0.002 10 ( -7 ) , P = 0.004 10 ( -6 ) , respectively ) .


A significantly lower incidence of POST was observed in Strefen and Siccoral groups at 0 and 1 h compared to Control group ( Strefen : P = 0.004 10 ( -2 ) , P = 0.007 10 ( -4 ) ; Siccoral : P = 0.003 10 ( -8 ) , P = 0.007 10 ( -5 ) , respectively ) .


A significantly lower incidence of POST was observed with Siccoral treatment at 0 h post extubation ( P = 0.002 vs. Strefen treatment ) .


Although POST incidence was not significantly different between the Stomatovis and Control groups , it was lower in the Stomatovis group at 0 and 1 h ( P = 0.026 and 0.013 , respectively ) .


The incidence of POST was similar in all groups at 6 and 24 h post extubation ( P = 0.141 and 0.426 , respectively ) .


Siccoral and Strefen can be effective in relieving POST in the early hours after extubation .


Etomidate causes pain when injected intravenously .


In this study we sought to determine if pretreatment by ondansetron reduces the pain on injection of etomidate .


In this randomized , double blinded , placebo-controlled clinical trial , 20 patients of both sexes aged between 18 and 50 years of American Society of Anesthesiologists ( ASA ) physical status class I or II , whom were candidates for various elective surgical procedures and need more than one intravenous access were enrolled in the study .


On arrival to the operating room two 22 gauge cannulas were inserted into veins on the dorsum of both hands .


Following the infusion of 100mL normal saline into both intravenous lines , using an elastic band , venous drainage of hands was occluded at midarm .


The patients were administered 8 mg ( 2 mL ) of ondansetron into one hand and 2 mL of 0.9 % saline into the other hand at the same time .


The elastic band was removed after 1 min and 2mg ( 1 mL ) of etomidate was administered at the same rate simultaneously into intravenous lines .


The patients were asked to give a score of pain based on a verbal analog scale ( VAS ) to each hand .


A total number of 20 patients were studied ( male = 55 % , female = 45 % ) .


The mean age of the participants was 37.5 13.1 years old and the mean weight was 67.7 7.3 kg .


The mean VAS for injection pain of etomidate after pre-administration of intravenous ondansetron was 1.5 1.2 which was lower compared to pre-administration of placebo ( 3.2 2.8 , p < 0.05 ) .


This study illustrates that pre-treatment with intravenous ondansetron significantly reduces the pain on injection of etomidate .


This study sought to determine pharmacodynamic effects during transition from intravenous cangrelor to oral ticagrelor and from oral ticagrelor to intravenous cangrelor .


Cangrelor is an intravenous antagonist of P2Y12 and its use will require transition to and from oral agents .


Patients ( n = 12 ) with stable coronary artery disease who were taking aspirin 81 mg daily were recruited .


On study day 1 , they received a bolus plus 2-h infusion of cangrelor plus a 180-mg dose of ticagrelor at either 0.5 h ( n = 6 ) or 1.25 h ( n = 6 ) .


Pharmacodynamic effects ( light transmission platelet aggregation in response to 20 and 5 mol/l adenosine diphosphate , VerifyNow , P2Y12 assay ( Accumetrics , San Diego , California ) , vasodilator-stimulated phosphoprotein index , and flow cytometry ) were assessed during and after the cangrelor infusion .


Patients took 90 mg of ticagrelor twice daily for either 6 ( n = 6 ) or 7 ( n = 6 ) doses .


On study day 5 , pharmacodynamic effects were assessed before and during a bolus plus 2-h infusion of cangrelor .


During cangrelor infusion , extensive inhibition of platelet function reflected by limited residual platelet reactivity was apparent .


After cangrelor was stopped , the antiplatelet effects of ticagrelor were preserved despite a modest increase in platelet reactivity .


Ticagrelor given before or during infusion of cangrelor did not attenuate the pharmacodynamic effects of cangrelor .


The pharmacodynamic effects of ticagrelor were preserved when ticagrelor was given during infusion of cangrelor .


Consistent with the reversible binding of ticagrelor , this oral P2Y12 antagonist can be administered before , during , or after treatment with cangrelor .


Several studies conducted in Northeast Tanzania have documented declines in malaria transmission even before interventions were scaled up .


One explanation for these reductions may be the changes in socio-environmental conditions associated with economic development , and in particular improvements in housing construction .


This analysis seeks to identify ( 1 ) risk factors for malaria incidence among young children and ( 2 ) household and environmental factors associated with mosquito vector numbers collected in the child 's sleeping area .


Both analyses focus on housing construction quality as a key determinant .


For 435 children enrolled in a larger trial of intermittent preventive treatment for malaria in infants in the Korogwe District in Tanga , Northeastern Tanzania , detailed information on their dwelling characteristics were collected in the last year of the trial .


Principal components analysis was used to construct an index of housing structure quality and converted to quintile units for regression analysis .


Univariate and multivariate random effects negative binomial regressions were used to predict risk factors for child malaria incidence and the mean total number of indoor female Anopheles gambiae and funestus mosquitoes collected per household across three occasions .


Building materials have substantially improved in Korogwe over time .


Multivariate regressions showed that residing in rural areas ( versus urban ) increased malaria incidence rates by over three-fold and mean indoor female A. gambiae and funestus numbers by nearly two-fold .


Compared to those residing in the lowest quality houses , children residing in the highest quality houses had one-third lower malaria incidence rates , even when wealth and rural residence were controlled for .


Living in the highest quality houses reduced vector numbers while having cattle near the house significantly increased them .


Results corroborate findings from other studies that show associations between malaria incidence and housing quality ; associations were concentrated amongst the highest quality houses .


Weight loss of 5 % to 10 % can improve type 2 diabetes and related comorbidities .


Few safe , effective weight-management drugs are currently available .


To investigate efficacy and safety of liraglutide vs placebo for weight management in adults with overweight or obesity and type 2 diabetes .


Fifty-six-week randomized ( 2:1:1 ) , double-blind , placebo-controlled , parallel-group trial with 12-week observational off-drug follow-up period .


The study was conducted at 126 sites in 9 countries between June 2011 and January 2013 .


Of 1361 participants assessed for eligibility , 846 were randomized .


Inclusion criteria were body mass index of 27.0 or greater , age 18 years or older , taking 0 to 3 oral hypoglycemic agents ( metformin , thiazolidinedione , sulfonylurea ) with stable body weight , and glycated hemoglobin level 7.0 % to 10.0 % .


Once-daily , subcutaneous liraglutide ( 3.0 mg ) ( n = 423 ) , liraglutide ( 1.8 mg ) ( n = 211 ) , or placebo ( n = 212 ) , all as adjunct to 500 kcal/d dietary deficit and increased physical activity ( 150 min/wk ) .


Three coprimary end points : relative change in weight , proportion of participants losing 5 % or more , or more than 10 % , of baseline weight at week 56 .


Baseline weight was 105.7 kg with liraglutide ( 3.0-mg dose ) , 105.8 kg with liraglutide ( 1.8-mg dose ) , and 106.5 kg with placebo .


Weight loss was 6.0 % ( 6.4 kg ) with liraglutide ( 3.0-mg dose ) , 4.7 % ( 5.0 kg ) with liraglutide ( 1.8-mg dose ) , and 2.0 % ( 2.2 kg ) with placebo ( estimated difference for liraglutide [ 3.0 mg ] vs placebo , -4.00 % [ 95 % CI , -5.10 % to -2.90 % ] ; liraglutide [ 1.8 mg ] vs placebo , -2.71 % [ 95 % CI , -4.00 % to -1.42 % ] ; P < .001 for both ) .


Weight loss of 5 % or greater occurred in 54.3 % with liraglutide ( 3.0 mg ) and 40.4 % with liraglutide ( 1.8 mg ) vs 21.4 % with placebo ( estimated difference for liraglutide [ 3.0 mg ] vs placebo , 32.9 % [ 95 % CI , 24.6 % to 41.2 % ] ; for liraglutide [ 1.8 mg ] vs placebo , 19.0 % [ 95 % CI , 9.1 % to 28.8 % ] ; P < .001 for both ) .


Weight loss greater than 10 % occurred in 25.2 % with liraglutide ( 3.0 mg ) and 15.9 % with liraglutide ( 1.8 mg ) vs 6.7 % with placebo ( estimated difference for liraglutide [ 3.0 mg ] vs placebo , 18.5 % [ 95 % CI , 12.7 % to 24.4 % ] , P < .001 ; for liraglutide [ 1.8 mg ] vs placebo , 9.3 % [ 95 % CI , 2.7 % to 15.8 % ] , P = .006 ) .


More gastrointestinal disorders were reported with liraglutide ( 3.0 mg ) vs liraglutide ( 1.8 mg ) and placebo .


No pancreatitis was reported .


Among overweight and obese participants with type 2 diabetes , use of subcutaneous liraglutide ( 3.0 mg ) daily , compared with placebo , resulted in weight loss over 56 weeks .


Further studies are needed to evaluate longer-term efficacy and safety .


clinicaltrials.gov Identifier : NCT01272232 .


To investigate the association between consecutively measured thromboelastographic ( TEG ) tracings and outcome in patients with severe sepsis .


Multicentre prospective observational study in a subgroup of the Scandinavian Starch for Severe Sepsis/Septic Shock ( 6S ) Trial ( NCT00962156 ) comparing hydroxyethyl starch ( HES ) 130/0 .42 vs. Ringer 's acetate for fluid resuscitation in severe sepsis .


TEG ( standard and functional fibrinogen ) was measured consecutively for 5 days , and clinical data including bleeding and death was retrieved from the trial database .


Statistical analyses included Cox regression with time-dependent covariates and joint modelling techniques .


Of 267 eligible patients , we analysed 260 patients with TEG data .


At 90 days , 68 ( 26 % ) had bled and 139 ( 53 % ) had died .


For all TEG variables , hypocoagulability according to the reference range was significantly associated with increased risk of death .


In a linear model , hazard ratios for death were 6.03 ( 95 % confidence interval , 1.64-22 .17 ) for increased clot formation speed , 1.10 ( 1.04-1 .16 ) for decreased angle , 1.09 ( 1.05-1 .14 ) for decreased clot strength and 1.12 ( 1.06-1 .18 ) for decreased fibrinogen contribution to clot strength ( functional fibrinogen MA ) , showing that deterioration towards hypocoagulability in any TEG variable significantly increased the risk of death .


Patients treated with HES had lower functional fibrinogen MA than those treated Ringer 's acetate , which significantly increased the risk of subsequent bleeding [ HR 2.43 ( 1.16-5 .07 ) ] and possibly explained the excess bleeding with HES in the 6S trial .


In our cohort of patients with severe sepsis , progressive hypocoagulability defined by TEG variables was associated with increased risk of death and increased risk of bleeding .


Knowledge about the effects of exercise in severe and endstage osteoarthritis ( OA ) is limited .


The aim was to evaluate the efficacy of a neuromuscular exercise program in patients with clinically severe hip or knee OA .


This was a randomized controlled assessor-blinded trial .


Patients received an educational package ( care-as-usual ) only , or care-as-usual plus an 8-week neuromuscular exercise intervention ( NEMEX-TJR ) .


NEMEX-TJR was supervised by a physiotherapist , twice weekly for 1 h.


The primary outcome was Activities of Daily Living ( ADL ) subscale from the Hip disability and Osteoarthritis Outcome Score ( HOOS ) and the Knee Injury and Osteoarthritis Outcome Score ( KOOS ) questionnaire .


The secondary outcomes were the HOOS/KOOS subscales Pain , Symptoms , Sport and Recreation , and Joint-related Quality of Life .


Exploratory outcomes were functional performance measures and lower limb muscle power .


Included were 165 patients , 56 % female , average age 67 years ( SD 8 ) , and a body mass index of 30 ( SD 5 ) , who were scheduled for primary hip or knee replacement .


The postintervention difference between mean changes in ADL was 7.2 points ( 95 % CI 3.5 to 10.9 , p = 0.0002 ) in favor of NEMEX-TJR compared with control .


Second , there were statistically significant differences between groups in favor of NEMEX-TJR on all self-reported outcomes and most functional performance tests ( walk , chair stands , and 1-leg knee bends ) .


Stratified analyses according to joint revealed moderate effect size for ADL for hip patients ( 0.63 , 95 % CI 0.26 to 1.00 ) .


Corresponding effect size for knee patients was small ( 0.23 95 % CI -0.14 to 0.60 ) .


Feasibility of neuromuscular exercise was confirmed in patients about to have total joint replacement .


Self-reported activities of daily living and objective performance were improved and pain reduced immediately following 8 weeks of neuromuscular exercise .


While the effects were moderate in hip OA , they were only small in knee OA .


ClinicalTrials.gov Identifier : NCT01003756 .


Clinical effectiveness of previous regimens to treat Plasmodium vivax infection have been hampered by compliance .


We aimed to assess the dose-response , safety , and tolerability of single-dose tafenoquine plus 3-day chloroquine for P vivax malaria radical cure .


In this double-blind , randomised , dose-ranging phase 2b study , men and women ( aged 16 years ) with microscopically confirmed P vivax monoinfection ( parasite density > 100 to < 100,000 per L blood ) were enrolled from community health centres and hospitals across seven sites in Brazil , Peru , India , and Thailand .


Patients with glucose-6-phosphate dehydrogenase enzyme activity of less than 70 % were excluded .


Eligible patients received chloroquine ( days 1-3 ) and were randomly assigned ( 1:1:1:1:1:1 ) by a computer-generated randomisation schedule to receive single-dose tafenoquine 50 mg , 100 mg , 300 mg , or 600 mg , primaquine 15 mg for 14 days , or chloroquine alone .


Randomisation was stratified by baseline parasite count ( 7500 and > 7500 per L blood ) .


The primary efficacy endpoint was relapse-free efficacy at 6 months from initial dose ( ie , clearance of initial infection without subsequent microscopically confirmed infection ) , analysed by intention to treat .


This study is registered with ClinicalTrials.gov , number NCT01376167 .


Between Sept 19 , 2011 , and March 25 , 2013 , 329 patients were randomly assigned to a treatment group ( chloroquine plus tafenoquine 50 mg [ n = 55 ] , 100 mg [ n = 57 ] , 300 mg [ n = 57 ] , 600 mg [ n = 56 ] ; or to chloroquine plus primaquine [ n = 50 ] ; or chloroquine alone [ n = 54 ] ) .


Relapse-free efficacy at 6 months was 577 % ( 95 % CI 43-70 ) with tafenoquine 50 mg , 541 % ( 40-66 ) with tafenoquine 100 mg , 892 % ( 77-95 ) with tafenoquine 300 mg , 919 % ( 80-97 ) with tafenoquine 600 mg , 773 % ( 63-87 ) with primaquine , and 375 % ( 23-52 ) with chloroquine alone .


Tafenoquine 300 mg and 600 mg had better efficacy than chloroquine alone ( treatment differences 517 % [ 95 % CI 35-69 ] , p < 00001 , with tafenoquine 300 mg and 545 % [ 38-71 ] , p < 00001 , with tafenoquine 600 mg ) , as did primaquine ( treatment difference 399 % [ 21-59 ] , p = 00004 ) .


Adverse events were similar between treatments .


29 serious adverse events occurred in 26 ( 8 % ) of 329 patients ; QT prolongation was the most common serious adverse event ( 11 [ 3 % ] of 329 ) , occurring in five ( 2 % ) of 225 patients receiving tafenoquine , four ( 8 % ) of 50 patients receiving primaquine , and two ( 4 % ) of 54 patients receiving chloroquine alone , with no evidence of an additional effect on QT of chloroquine plus tafenoquine coadministration .


Single-dose tafenoquine 300 mg coadministered with chloroquine for P vivax malaria relapse prevention was more efficacious than chloroquine alone , with a similar safety profile .


As a result , it has been selected for further clinical assessment in phase 3 .


GlaxoSmithKline , Medicines for Malaria Venture .


To compare the effects of a combination of therapeutic exercise and ultrasound with or without additional microcurrent therapy in infants with congenital muscular torticollis involving the entire sternocleidomastoid muscle .


Prospective , randomized , placebo-controlled trial .


An outpatient rehabilitation clinic in a tertiary university hospital .


Infants ( n = 20 ) with congenital muscular torticollis involving the entire sternocleidomastoid muscle .


Group 1 comprised 10 infants who received therapeutic exercise with ultrasound alone and Group 2 comprised 10 infants who received the same treatment with microcurrent therapy .


Passive cervical rotational range of motion was measured at before treatment and one , two , three , and six months after initial treatment .


Thickness , cross-sectional area , and red pixel intensity on colour histograms , which were all assessed before treatment and at three months after initial treatment .


Additionally , the duration of treatment was measured .


The mean passive cervical rotational range of motion measured at three months posttreatment was significantly greater in Group 2 ( 101.1 ) than that in Group 1 ( 86.4 ) , and the thickness , cross-sectional area , and red pixel intensity of the affected sternocleidomastoid muscle were all less in Group 2 ( 7.8 mm , 100.3 mm ( 2 ) , and 126.1 , respectively ) than those in Group 1 ( 9.6 mm , 121.5 mm2 , and 140.5 , respectively ) .


The mean duration of treatment was significantly shorter in Group 2 ( 2.6 months ) than in Group 1 ( 6.3 months ) .


Microcurrent therapy may increase the efficacy of therapeutic exercise with ultrasound for the treatment of congenital muscular torticollis involving the entire sternocleidomastoid muscle .


Decreases in the bioavailability of rifampicin ( RFP ) can lead to the development of drug resistance and treatment failure .


Therefore , we investigated the relative bioavailability of RFP from one four-drug fixed-dose combination ( FDC ; formulation A ) and three two-drug FDCs ( formulations B , C , and D ) used in China , compared with RFP in free combinations of these drugs ( reference ) , in healthy volunteers .


Eighteen and twenty healthy Chinese male volunteers participated in two open-label , randomized two-period crossover ( formulations A and C ) or one three-period crossover ( formulations B and D ) study , respectively .


The washout period between treatments was 7 days .


Bioequivalence was assessed based on 90 % confidence intervals , according to two one-sided t-tests .


All analyses were done with DAS 3.1.5 ( Mathematical Pharmacology Professional Committee of China , Shanghai , China ) .


Mean pharmacokinetic parameter values of RFP obtained for formulations A , B , C , and D products were 11.42 3.41 g/ml , 7.86 5.78 g/ml , 13.05 6.80 g/ml , and 16.18 3.87 g/ml , respectively , for peak plasma concentration ( C max ) , 91.43 30.82 gh-1ml-1 , 55.49 37.58 gh-1ml-1 , 96.50 47.24 gh-1ml-1 , 101.47 33.07 gh-1ml-1 , respectively , for area under the concentration-time curve ( AUC 0-24 h ) .


Although the concentrations of RFP for formulations A , C , and D were within the reported acceptable therapeutic range , only formulation A was bioequivalent to the reference product .


The three two-drug FDCs ( formulations B , C and D ) displayed inferior RFP bioavailability compared with the reference ( Chinese Clinical Trials registration number : ChiCTR-TTRCC-12002451 ) .


Our aim was to ascertain the efficacy of golimumab compared with placebo in the prevention of atherosclerosis and arterial stiffness in AS .


A randomized , double-blind , placebo-controlled pilot study was performed in which AS patients were treated with golimumab ( n = 20 ) and placebo ( n = 21 ) for 12 months .


Patients from the placebo group who failed to achieve a 20 % response to Assessment of SpondyloArthritis international Society criteria ( ASAS20 ) at 6 months received open-label golimumab .


Intima-media thickness ( IMT ) , pulse wave velocity ( PWV ) and augmentation index ( AIx ) were measured at baseline , 6 and 12 months .


At 6 months , 11/20 ( 55 % ) and 3/21 ( 14 % ) patients from the golimumab and placebo groups achieved an ASAS20 response , respectively ( P = 0.006 ) .


There was no significant difference in the change of the vascular parameters between the two groups .


In the placebo group , significantly greater progression of the mean IMT [ from 0.51 mm ( S.D. 0.07 ) at baseline to 0.53 mm ( S.D. 0.08 ) at 6 months , P = 0.044 ] and PWV ( from 12.2 m/s ( S.D. 1.6 ) at baseline to 12.6 m/s ( S.D. 1.3 ) , P = 0.028 ] were observed .


There was a trend towards progression of the mean IMT in the golimumab group ( P = 0.099 ) but the maximum IMT , PWV and AIx remained unchanged .


At 12 months the changes in vascular parameters were similar between the early and delayed ( or no ) golimumab groups .


Uncontrolled inflammation may result in a significant progression in IMT and PWV in patients with AS .


Arterial dysfunction may be prevented by golimumab over a period of 6 months , probably because of effective suppression of inflammation .


clinicaltrials.gov ( NCT01212653 )


This study investigated the dietary effect of including pigmented rice bran with or without plant sterols on lipid profiles during energy restriction-induced weight loss in overweight and obese adults not taking cholesterol-lowering medication .


In addition , the study examined the effect of intervention on biomarkers of oxidative stress and inflammation .


A group of 24 overweight and obese adults ( age : 43 6 years , body mass index 32 1 kg/m ( 2 ) , 18 females ) were randomized to a 25 % calorie-restricted diet containing either pigmented rice bran ( RB ) or the RB with addition of plant sterols ( RB+PS ) snack bars for 8 weeks .


The individualized nutrient-balanced diet contained 70 % of daily energy needs assessed from indirect calorimetry measured resting energy expenditure ( EE ) and physical activity-related EE assessed using accelerometry .


Anthropometrics , blood pressure , blood lipids , glucose , urinary F2-isoprostanes , C-reactive protein , insulin , and leptin were measured at baseline and after 8 weeks of intervention .


Participants lost approximately 4.7 2.2 kg ( p < 0.001 ) .


Weight loss was not significant between the RB+PS and RB group ( p = 0.056 ) .


Changes in body fat corresponded to changes in body weight .


Average decrease in total cholesterol was significantly higher in the RB+PS group than in the RB group ( difference 36 25 g/dL vs 7 16 g/dL ; p = 0.044 ) .


A similar pattern was observed for the decrease in low-density lipoprotein ( LDL ) cholesterol ( difference 22.3 25.2 g/dL vs 4.4 18.9 g/dL ; p = 0.062 ) .


Changes in systolic blood pressure , serum levels of leptin , and F2-isoprostanes were significant between baseline values and after 8 weeks on the diet in both groups ( p < 0.05 ) but did not differ between the 2 groups .


A nutrient-balanced and energy-restricted diet supplemented with rice bran and plant sterols resulted in a significant decrease in total and LDL cholesterol in overweight and obese adults .


To evaluate efficacy and safety of Baimai ointment ( see symbol in text ) in the treatment of wrist-dysfunction after distal radius fracture .


From April , 2011 to June , 2012 , 43 patients with distal radius fracture were treated with plaster fixation .


All the patients were divided into two group : test group and control group .


Twenty-one patients in test group and 22 in control group , and the baseline was balance ( P > 0.05 ) .


The 21 patients in test group were treated with Baimai ointment ( see symbol in text ) , fomentation , functional exercises .


The 22 patients in control group were treated with placebo , fomentation , functional exercises .


Foment affected side wrist with wet towel in 20 min before medication , with the temperature between 50 degrees C and 60 degrees C. Smear drugs uniformly in range of 3 cm in the vicinity of palm stripes after drying ( about 3 g ) and take functional exercises for the activities of wrist and hand .


Continuous follow the program per 8 hours once and follow-up for 8 weeks .


The Wrist 's pain was assessed with VAS .


The wrist 's activities were measured with the protractor of orthopedic .


Measure The grip strength was measured with dynamometer .


The wrist 's function were assessed with the table of Cooney .


The test group had a significantly better results than those of control group in the extent of wrist 's pain throughout the treatment ( P < 0.001 ) , and grip strength on the 28th day and the 56th day ( P < 0.05 ) , and Cooney functional assessment on the 56th day ( P < 0.05 ) .


Wrist 's activities had no significane difference throughout the 8 weeks ( P > 0.05 ) .


There were no drug adverse reactions occurred .


Tibetan Baimai ointment ( see symbol in text ) has the treatment of wrist-dysfunction after distal radius fracture for external use , which can reduce the extent of wrist 's pain , promote grip strength recovery in the middle and late of process , promote wrist 's function recovery latterly , and safety for external use .


This study aimed to investigate the effect of both history of intermittent atrial tachyarrhythmias ( IAT ) and in-trial IAT on the risk of heart failure ( HF ) or death comparing cardiac resynchronization therapy with defibrillator ( CRT-D ) to implantable cardioverter-defibrillator ( ICD ) treatment in mildly symptomatic HF patients with left bundle branch block ( LBBB ) .


Limited data exist regarding the benefit of CRT-D in patients with IAT .


The benefit of CRT-D in reducing the risk of HF/death was evaluated using multivariate Cox models incorporating the presence of , respectively , a history of IAT at baseline and time-dependent development of in-trial IAT during follow-up in 1,264 patients with LBBB enrolled in the MADIT-CRT ( Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy ) study .


The overall beneficial effect of CRT-D versus ICD on the risk of HF/death was not significantly different between LBBB patients with or without history of IAT ( HR : 0.50 , p = 0.028 , and HR : 0.46 , p < 0.001 , respectively ; p for interaction = 0.79 ) .


Among patients who had in-trial IAT , CRT-D was associated with a significant 57 % reduction in the risk of HF/death compared with ICD-only therapy ( HR : 0.43 , p = 0.047 ) , similar to the effect of the device among patients who did not have IAT ( HR : 0.47 , p < 0.001 ; p for interaction = 0.85 ) .


The percentage of patients with biventricular pacing 92 % was similar in both groups ( p = 0.43 ) .


Consistent results were shown for the benefit of CRT-D among patients who had in-trial atrial fibrillation/flutter ( HR : 0.30 , p = 0.027 ; p for interaction = 0.41 ) .


In the MADIT-CRT study , the clinical benefit of CRT-D in LBBB patients was not attenuated by prior history of IAT or by the development of in-trial atrial tachyarrhythmias .


( MADIT-CRT : Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy ; NCT00180271 ) .


QVA149 is a novel , inhaled , once-daily dual bronchodilator containing a fixed-dose combination of the long-acting 2-agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium ( NVA237 ) , for the treatment of chronic obstructive pulmonary disease ( COPD ) .


This study evaluated the effects of QVA149 on exercise tolerance , hyperinflation , lung function and lung volumes versus placebo and tiotropium .


Patients with moderate-to-severe COPD were randomized to QVA149 110/50 g , placebo or tiotropium 18 g once daily in a blinded , 3-period crossover study for 3 weeks .


The primary endpoint was exercise endurance time at Day 21 for QVA149 versus placebo .


Eighty-five patients were randomized ; 86 % completed the study .


QVA149 significantly improved exercise endurance time at Day 21 compared with placebo ( least squares mean treatment difference 60 s [ p = 0.006 ] ) .


No significant improvements in exercise endurance time at Day 21 between QVA149 and tiotropium were found .


Dynamic inspiratory capacity ( IC ) at exercise isotime , trough forced expiratory volume in 1 s , residual volume and functional residual capacity showed significant improvements with QVA149 from Day 1 of treatment that were maintained throughout the study .


The safety profiles were similar across groups .


In patients with moderate-to-severe COPD , once-daily QVA149 significantly improved exercise endurance time compared with placebo which was associated with sustained reductions of lung hyperinflation as indicated by significant improvement in IC at rest and during exercise .


ClinicalTrials.gov NCT01294787 .


Dual bronchodilation with QVA149 decreases lung hyperinflation and improves exercise tolerance and lung function in patients with moderate-to-severe COPD .


Persons with type 2 diabetes mellitus ( T2DM ) are at increased risk for decline in cognitive function , reduced brain volume , and increased white matter lesions in the brain .


Poor control of blood pressure ( BP ) and lipid levels are risk factors for T2DM-related cognitive decline , but the effect of intensive treatment on brain function and structure is unknown .


To examine whether intensive therapy for hypertension and combination therapy with a statin plus a fibrate reduces the risk of decline in cognitive function and total brain volume ( TBV ) in patients with T2DM .


A North American multicenter clinical trial including 2977 participants without baseline clinical evidence of cognitive impairment or dementia and with hemoglobin A1c ( HbA1c ) levels less than 7.5 % randomized to a systolic BP goal of less than 120 vs less than 140 mm Hg ( n = 1439 ) or to a fibrate vs placebo in patients with low-density lipoprotein cholesterol levels less than 100 mg/dL ( n = 1538 ) .


Participants were recruited from August 1 , 2003 , through October 31 , 2005 , with the final follow-up visit by June 30 , 2009 .


Cognition was assessed at baseline and 20 and 40 months .


A subset of 503 participants underwent baseline and 40-month brain magnetic resonance imaging to assess for change in TBV and other structural measures of brain health .


Baseline mean HbA1c level was 8.3 % ; mean age , 62 years ; and mean duration of T2DM , 10 years .


At 40 months , no differences in cognitive function were found in the intensive BP-lowering trial or in the fibrate trial .


At 40 months , TBV had declined more in the intensive vs standard BP-lowering group ( difference , -4.4 [ 95 % CI , -7.8 to -1.1 ] cm ( 3 ) ; P = .01 ) .


Fibrate therapy had no effect on TBV compared with placebo .


In participants with long-standing T2DM and at high risk for cardiovascular events , intensive BP control and fibrate therapy in the presence of controlled low-density lipoprotein cholesterol levels did not produce a measurable effect on cognitive decline at 40 months of follow-up .


Intensive BP control was associated with greater decline in TBV at 40 months relative to standard therapy .


TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT00000620 .


Providing women with contraceptive methods following abortion is important to reduce repeat abortion rates , yet evidence for effective post-abortion family planning interventions are limited .


This protocol outlines the evaluation of a mobile phone-based intervention using voice messages to support post-abortion family planning in Cambodia .


A single blind randomised controlled trial of 500 participants .


Clients aged 18 or over , attending for abortion at four Marie Stopes International clinics in Cambodia , owning a mobile phone and not wishing to have a child at the current time are randomised to the mobile phone-based intervention or control ( standard care ) with a 1:1 allocation ratio.The intervention comprises a series of six automated voice messages to remind clients about available family planning methods and provide a conduit for additional support .


Clients can respond to message prompts to request a phone call from a counsellor , or alternatively to state they have no problems .


Clients requesting to talk to a counsellor , or who do not respond to the message prompts , receive a call from a Marie Stopes International Cambodia counsellor who provides individualised advice and support regarding family planning .


The duration of the intervention is 3 months .


The control group receive existing standard of care without the additional mobile phone-based support.We hypothesise that the intervention will remind clients about contraceptive methods available , identify problems with side effects early and provide support , and therefore increase use of post-abortion family planning , while reducing discontinuation and unsafe method switching.Participants are assessed at baseline and at 4 months .


The primary outcome measure is use of an effective modern contraceptive method at 4 months post abortion .


Secondary outcome measures include contraception use , pregnancy and repeat abortion over the 4-month post-abortion period.Risk ratios will be used as the measure of effect of the intervention on the outcomes , and these will be estimated with 95 % confidence intervals .


All analyses will be based on the ` intention to treat ' principle .


This study will provide evidence on the effectiveness of a mobile phone-based intervention using voice messages to support contraception use in a population with limited literacy .


Findings could be generalisable to similar populations in different settings .


ClinicalTrials.gov Identifier : NCT01823861 .


Cognitive-behavioural treatment can nowadays be delivered through the Internet .


This form of treatment can have various advantages with regard to availability and accessibility .


Previous studies showed that Internet-based treatment for chronic pain is effective compared to waiting-list control groups .


We conducted a randomized controlled trial comparing an Internet-based cognitive-behavioural intervention with e-mail therapist contact to a face-to-face cognitive-behavioural group intervention .


Of the 72 participants who were randomly assigned to an Internet or a group course , 50 participants completed the intervention .


Participants were assessed at baseline ( T0 ) , immediately after the 7-week course ( T1 ) and at the booster session 2 months later ( T2 ) .


Pain-related catastrophizing was the primary outcome measure .


Pain intensity , fatigue , pain-related interference , locus of control , pain coping , global health-related quality of life and medical expenses were secondary outcome variables .


Significant improvement was found on catastrophizing , pain coping , locus of control and aspects of global health-related quality of life in both the Internet and the group courses directly after the course and at the booster session .


Pain intensity was improved in both courses at the booster session .


At T2 , improvement in catastrophizing , pain intensity , pain coping and some quality of life dimensions was significantly greater in completers of the Internet course than in the group course .


Furthermore , the Internet course was cost-effective compared to the group course .


We conclude that the Internet-based cognitive-behavioural intervention was at least as effective as the face-to-face group intervention and , on some outcome measures appeared to be even more effective .


To describe the prevalence and risk factors for incomplete bladder emptying after midurethral slings ( MUS ) in a large multicenter trial .


Five hundred ninety-seven women were randomized to retropubic ( RMUS ) or transobturator midurethral slings as part of the Trial of MidUrethral Slings study .


Demographic data and voiding symptoms were obtained preoperatively along with urodynamics .


Patients underwent a standardized voiding trial at discharge after continence surgery .


Incomplete bladder emptying was defined as a postvoid residual of > 150 mL .


Three-quarters of patients ( 454 of 597 ) were self-voiding at discharge , whereas 114 of 597 ( 19 % ) were managed with an indwelling urethral catheter and 29 of 597 ( 5 % ) with intermittent catheterization .


At 2 weeks , only 38 of 586 ( 6 % ) reported any catheter use , and by 6 weeks , only 9 of 587 ( 2 % ) reported any catheter use .


Women with incomplete bladder emptying at discharge were more likely to have had a RMUS ( odds ratio 1.79 ; 95 % confidence interval 1.22-2 .62 ) and to report preoperative voiding accommodations such as straining to void ( odds ratio 1.75 ; 95 % confidence interval 1.04-2 .96 ) .


Urodynamic and clinicodemographic parameters were not predictive of incomplete bladder emptying .


Incomplete bladder emptying at discharge after MUS is common , especially after RMUS , but of short duration .


Risk factors include preoperative voiding accommodations such as straining or bending over to void , but other variables including urodynamics did not predict incomplete bladder emptying after MUS .


The prevalence and socioeconomic cost of late life depression ( LLD ) is on the rise , while the response rate to antidepressant trials remains poor .


Various mind-body therapies are being embraced by patients as they are considered safe and potentially effective , yet little is known regarding the effectiveness of such therapies to improve LLD symptoms .


Among the mind-body therapies currently in practice , the results of our pilot study have shown that a particular meditation technique called Sahaj Samadhi Meditation , which belongs to the category of meditation termed automatic self-transcending meditation ( ASTM ) may have some promise in improving cardiovascular autonomic disturbances associated with LLD as well as ameliorating symptoms of depression and anxiety .


Patients between the ages of 60 and 85 with LLD will be randomized either to ASTM plus treatment as usual ( TAU ) or TAU alone to assess changes in cardiovascular autonomic parameters , neuropsychological symptoms of depression and anxiety as well as quality of life .


The instructional phase of the intervention consists of 4 consecutive days of meditation training , after which participants are encouraged to meditate twice daily for twenty minutes each time at home .


The intervention also includes once weekly follow up sessions for the subsequent 11 weeks .


The planned study has one and a half year recruitment period .


Participants will be assessed at baseline and at 4 , 8 , 12 and 24 weeks post intervention .


This study should provide a unique data source from a randomized , controlled , longitudinal trial to investigate the effects of a form of ASTM on cardiovascular autonomic and neuropsychological health in LLD .


Clinicaltrials.gov NCT02149810 , date registered : 05/28/2014 .


Acupuncture is safe and may be effective for severe chronic constipation .


The World Gastroenterology Organisation recommends prucalopride for patients for whom previous laxative use failed to provide satisfactory relief .


In this prospective , multi-centre , randomised controlled trial , five hundred sixty patients with severe chronic constipation ( two or less spontaneous complete bowel movements per week ) from 14 centres will be randomised to receive either electroacupuncture or prucalopride .


Participants in the electroacupuncture group will receive electroacupuncture for eight weeks , while participants in the control group will take prucalopride ( 2 mg once daily ) for 32 weeks .


The primary outcome measure is the proportion of patients having 3 spontaneous , complete bowel movements per week , averaged over week three to eight .


The secondary outcome measures include eight items , including the proportion of patients having 3 spontaneous , complete bowel movements per week averaged over week 9-32 , the proportion of patients with one or more increases in spontaneous , complete bowel movements per week from baseline , mean Bristol Stool Scale , etc. .


Statistical analysis will include the CMH test , nonparametric tests and t tests .


We aimed to compare the effect of electroacupuncture versus prucalopride for severe chronic constipation .


The limitation of this study is that participants and acupuncturists will not be blinded .


ClinicalTrials.gov Identifier : NCT 02047045 .


It was investigated whether oral dexamethasone ( DEX ) administration improves exercise performance by reducing the initial rate of muscle fatigue development during dynamic exercise .


Using a double-blinded placebo controlled randomized crossover design , subjects ingested either 2 2 mg of DEX or placebo for five consecutive days .


Muscle function was investigated using one-legged kicking exercise and whole body performance was evaluated using a 20-m shuttle run and a 30-m sprint test .


One-legged dynamic knee-extensor exercise time to exhaustion was 29 35 % ( mean SD ) longer ( P < 0.05 ) in DEX compared to Placebo .


Likewise , total running distance in the shuttle run test was 19 23 % longer ( P < 0.05 ) , whereas 30-m sprint performance was unaltered .


During the initial 75 s of dynamic leg extensions , peak force and rate of force development determined from an electrically evoked twitch declined in a similar way in DEX and placebo .


Similarly , the EMG root mean square was similar with DEX and placebo treatment .


Short-term dexamethasone administration increases high-intensity one-legged kicking time to exhaustion and 20-m shuttle run performance , although sprint ability and the initial loss of muscular force generating capacity are similar after DEX and placebo .


The aim of the present study was to determine ( 1 ) whether successful intraoperative electromyography monitoring for lateral spread response ( LSR ) is possible with partial neuromuscular blockade ( NMB ) in subjects undergoing microvascular decompression ( MVD ) for hemifacial spasm and ( 2 ) the adequate level of NMB to achieve that goal .


A total of 61 patients in whom LSR was monitored during MVD were enrolled in the study .


Patients were randomly allocated to two groups : group TOF in which the NMB target was maintenance of two train-of-four ( TOF ) counts and group T1 in which the NMB target was maintenance of a T1/Tc ratio of 50 % ( T1 : first twitch height of TOF and Tc : control twitch height ) .


The adductor pollicis brevis muscle was used to monitor TOF responses .


The frequency of successful LSR monitoring , defined as successful baseline establishment and maintenance of LSR until surgical decompression , was compared between the two groups .


Of the 61 patients 2 were excluded from the study so that 30 patients in group TOF and 29 patients in group T1 were analyzed .


The success rate of LSR monitoring was clinically acceptable and significantly higher in group T1 than in group TOF , i.e. n = 15 ( 50.0 % ) in group TOF versus n = 24 ( 82.8 % ) in group T1 ( P = 0.008 ) , corresponding to a 32.8 % higher success rate in group T1 than group TOF ( 95 % CI : 13.9-51 .7 % ) .


Mean vecuronium infusion dose was smaller and mean TOF count was higher in group T1 than group TOF with a TOF count = 2 ( 1 ) in group TOF versus 3 ( 1 ) in group T1 ( P = 0.003 ) .


Mean sevoflurane and remifentanil infusion doses were not different between groups .


There was no incidence of spontaneous movement during microscopy in either group .


Maintenance of partial NMB with a target T1/Tc ratio of 50 % resulted in a clinically acceptable success rate of LSR monitoring and surgical condition during MVD .


Maintenance of partial NMB with a target T1/Tc ratio of 50 % rather than TOF count of two during LSR monitoring for MVD can therefore be recommended .


The United States spends a higher percentage of its gross domestic product on health care than any other country .


Previous efforts to curtail health care spending have had minimal impact .


We hypothesized that informing physicians of the cost of expensive cardiovascular diagnostic tests would change their ordering behavior .


Hospitalist physicians ( n = 38 ) were randomly assigned to either seeing or not seeing the cost of diagnostic tests , via a computer pop-up screen , at the time of order entry .


Patients were inpatients on a general medical service .


Cost-aware physicians were shown the cost of the test they ordered as well as the cost of similar tests with different costs .


There was a 4-month baseline period prior to randomization followed by a 4-month intervention period .


The primary outcome measure was a change in the proportion of imaging stress tests in the study period .


Of the total number of stress tests ordered ( imaging and nonimaging ) , cost-aware physicians ordered 89 % of their tests with imaging during both the baseline and study periods .


Cost-unaware physicians ordered 91 % imaging tests during the baseline period and 87 % during the study period .


There were no significant differences between the groups regarding change in ordering from baseline to study period .


Both groups showed a slight increase ( P < 0.03 ) in ordering the more expensive regadenoson nuclear stress tests ( cost-aware : 30 % baseline , 44 % study period ; cost-unaware : 36 % baseline , 41 % study period ) .


Informing physicians of the cost of certain diagnostic tests is not a sufficient intervention to influence their ordering behavior .


Clinical benefit response ( CBR ) , based on changes in pain , Karnofsky performance status , and weight , is an established palliative endpoint in trials for advanced gastrointestinal cancer .


We investigated whether CBR is associated with survival , and whether CBR reflects a wide-enough range of domains to adequately capture patients ' perception .


CBR was prospectively evaluated in an international phase III chemotherapy trial in patients with advanced pancreatic cancer ( n = 311 ) in parallel with patient-reported outcomes ( PROs ) .


The median time to treatment failure was 3.4 months ( range : 0-6 ) .


The majority of the CBRs ( n = 39 ) were noted in patients who received chemotherapy for at least 5 months .


Patients with CBR ( n = 62 ) had longer survival than non-responders ( n = 182 ) ( hazard ratio = 0.69 ; 95 % confidence interval : 0.51-0 .94 ; p = 0.013 ) .


CBR was predicted with a sensitivity and specificity of 77-80 % by various combinations of 3 mainly physical PROs .


A comparison between the duration of CBR ( n = 62 , median = 8 months , range = 4-31 ) and clinically meaningful improvements in the PROs ( n = 100-116 ; medians = 9-11 months , range = 4-24 ) showed similar intervals .


CBR is associated with survival and mainly reflects physical domains .


Within phase III chemotherapy trials for advanced gastrointestinal cancer , CBR can be replaced by a PRO evaluation , without losing substantial information but gaining complementary information .


MP29-02 ( Dymista ) , a novel intranasal formulation of azelastine hydrochloride ( AZE ) and fluticasone propionate ( FP ) , is significantly better than first-line therapy for the treatment of moderate-to-severe seasonal allergic rhinitis ( SAR ) , and is well tolerated following 52 weeks of continuous use in chronic rhinitis .


The aim of this study was to evaluate the long-term efficacy of MP29-02 versus FP in patients with chronic rhinitis .


In total , 612 chronic rhinitis patients ( perennial allergic rhinitis [ PAR ] , n = 424 ; nonallergic rhinitis , n = 188 ) aged 12 years or older were enrolled into this open-label , parallel-group study and randomized to MP29-02 ( 1 spray/nostril bid ) or FP nasal spray ( 2 sprays/nostril qd ) for 52 weeks .


Efficacy was assessed by change from baseline in PM reflective total nasal symptom score ( rTNSS ) , time to first achieve 100 % PM rTNSS reduction from baseline , and percentage of symptom-free days in the total and PAR populations posthoc .


MP29-02 reduced patients ' PM rTNSS from baseline significantly more than FP , from Day 1 up to and including week 28 ( -2.88 vs -2.53 ; P = .0048 ) , with treatment difference maintained for 52 weeks .


Fluctuation in significance after week 28 might be explained , at least in part , by decreasing sample size , permitted according to ICH guidelines .


By Day 1 almost twice as many MP29-02-patients were symptom free .


After 1 month , 71.1 % of MP29-02 patients experienced 100 % rTNSS reduction ( 60.3 % for FP ) , and did on a median of 9 days faster ( P = .0024 ) .


Over 52 weeks MP29-02 patients experienced 8.4 % more symptom-free days ( P = .0005 ) .


These results were mirrored in the PAR subpopulation .


These results confirm MP29-02 's wide therapeutic spectrum and assert its consistent superiority over an intranasal corticosteroid .


The clinical benefit of preventive eradication of unruptured brain arteriovenous malformations remains uncertain .


A Randomised trial of Unruptured Brain Arteriovenous malformations ( ARUBA ) aims to compare the risk of death and symptomatic stroke in patients with an unruptured brain arteriovenous malformation who are allocated to either medical management alone or medical management with interventional therapy .


Adult patients ( 18 years ) with an unruptured brain arteriovenous malformation were enrolled into this trial at 39 clinical sites in nine countries .


Patients were randomised ( by web-based system , in a 1:1 ratio , with random permuted block design [ block size 2 , 4 , or 6 ] , stratified by clinical site ) to medical management with interventional therapy ( ie , neurosurgery , embolisation , or stereotactic radiotherapy , alone or in combination ) or medical management alone ( ie , pharmacological therapy for neurological symptoms as needed ) .


Patients , clinicians , and investigators are aware of treatment assignment .


The primary outcome is time to the composite endpoint of death or symptomatic stroke ; the primary analysis is by intention to treat .


This trial is registered with ClinicalTrials.gov , number NCT00389181 .


Randomisation was started on April 4 , 2007 , and was stopped on April 15 , 2013 , when a data and safety monitoring board appointed by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health recommended halting randomisation because of superiority of the medical management group ( log-rank Z statistic of 410 , exceeding the prespecified stopping boundary value of 287 ) .


At this point , outcome data were available for 223 patients ( mean follow-up 333 months [ SD 197 ] ) , 114 assigned to interventional therapy and 109 to medical management .


The primary endpoint had been reached by 11 ( 101 % ) patients in the medical management group compared with 35 ( 307 % ) in the interventional therapy group .


The risk of death or stroke was significantly lower in the medical management group than in the interventional therapy group ( hazard ratio 027 , 95 % CI 014-054 ) .


No harms were identified , other than a higher number of strokes ( 45 vs 12 , p < 00001 ) and neurological deficits unrelated to stroke ( 14 vs 1 , p = 00008 ) in patients allocated to interventional therapy compared with medical management .


The ARUBA trial showed that medical management alone is superior to medical management with interventional therapy for the prevention of death or stroke in patients with unruptured brain arteriovenous malformations followed up for 33 months .


The trial is continuing its observational phase to establish whether the disparities will persist over an additional 5 years of follow-up .


National Institutes of Health , National Institute of Neurological Disorders and Stroke .


Corticosteroids are frequently used in cancer pain management despite limited evidence .


This study compares the analgesic efficacy of corticosteroid therapy with placebo .


Adult patients with cancer receiving opioids with average pain intensity 4 ( numeric rating scale [ NRS ] , 0 to 10 ) in the last 24 hours were eligible .


Patients were randomly assigned to methylprednisolone ( MP ) 16 mg twice daily or placebo ( PL ) for 7 days .


Primary outcome was average pain intensity measured at day 7 ( NRS , 0 to 10 ) ; secondary outcomes were analgesic consumption ( oral morphine equivalents ) , fatigue and appetite loss ( European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire C30 , 0 to 100 ) , and patient satisfaction ( NRS , 0 to 10 ) .


A total of 592 patients were screened ; 50 were randomly assigned , and 47 were analyzed .


Baseline opioid level was 269.9 mg in the MP arm and 160.4 mg in the PL arm .


At day-7 evaluation , there was no difference between the groups in pain intensity ( MP , 3.60 v PL , 3.68 ; P = .88 ) or relative analgesic consumption ( MP , 1.19 v PL , 1.20 ; P = .95 ) .


Clinically and statistically significant improvements were found in fatigue ( -17 v 3 points ; P .003 ) , appetite loss ( -24 v 2 points ; P = .003 ) , and patient satisfaction ( 5.4 v 2.0 points ; P = .001 ) in favor of the MP compared with the PL group , respectively .


There were no differences in adverse effects between the groups .


MP 32 mg daily did not provide additional analgesia in patients with cancer receiving opioids , but it improved fatigue , appetite loss , and patient satisfaction .


Clinical benefit beyond a short-term effect must be examined in a future study .


To investigate the role of epoxyeicosatrienoic acids ( EETs ) and prostaglandins ( PGs ) in retinal blood vessel calibers and vasodilation during flicker light stimulation in humans .


Twelve healthy nonsmokers participated in a balanced crossover study .


Oral fluconazole 400 mg and dispersible aspirin 600 mg were used to inhibit production of EETs and PGs , respectively .


Retinal imaging was performed 1 hour after drug ingestion with the Dynamic Vessel Analyzer .


Resting calibers of selected vessel segments were recorded in measurement units ( MU ) .


Maximum percentage dilations during flicker stimulation were calculated from baseline calibers .


We then studied six participants each after fluconazole and aspirin ingestions at 30-minute intervals for 2 hours .


Within-subject differences were assessed by ANOVA and Dunnett-adjusted pairwise comparisons with significance taken at P < 0.05 .


In crossover study participants , mean ( SD ) arteriole and venule dilations without drug administration were 4.4 % ( 2.0 % ) and 4.6 % ( 1.7 % ) , respectively .


Neither drug affected vasodilation during flicker stimulation .


Mean ( SD ) resting arteriole and venule calibers on no-drug visits were 119.6 ( 10.6 ) MU and 145.7 ( 17.0 ) MU , respectively .


Fluconazole reduced mean ( 95 % CI ) resting venule calibers by 5.1 ( 4.3 ) MU .


In repeated measures participants , neither drug affected vasodilations , but fluconazole reduced resting venule calibers over 2 hours ( P < 0.001 ) .


Epoxyeicosatrienoic acids and prostaglandins are unlikely to be primary mediators of flicker light-induced retinal vasodilation in humans .


However , EETs may play a role in the regulation of retinal vascular tone and blood flow under resting physiological conditions .


HS219 ( 40 mg chitosan-loaded chewing gum ) is designed to bind salivary phosphorus as an add-on to available phosphorus binders .


We performed a randomized , placebo-controlled , double-blind study to evaluate the efficacy and safety of HS219 in hemodialysis ( HD ) patients with hyperphosphatemia as an add-on to phosphorus binders .


Sixty-eight HD patients who were maintained on calcium carbonate ( n = 33 ) or sevelamer hydrochloride ( n = 35 ) were enrolled .


The primary end point was a change in serum phosphorus levels .


Secondary end points included changes in levels of salivary phosphorus , serum calcium , parathyroid hormone ( PTH ) , and intact fibroblast growth factor ( iFGF ) 23 .


Sixty-three patients chewed either HS219 ( n = 35 ) or placebo ( n = 28 ) for 30 min , three times a day , for 3 weeks .


HS219 was well tolerated and safe .


However , HS219 was not superior to placebo with additional reduction of serum phosphorus with respect to phosphorus binders at the end of the chewing period .


There were no significant effects of HS219 on reduction of salivary phosphorus , serum calcium , iPTH , or iFGF23 levels .


The chitosan-loaded chewing gum HS219 does not affect serum and salivary phosphorus levels in Japanese HD patients with hyperphosphatemia .


Our findings do not support previous findings that 20 mg of chitosan-loaded chewing gum reduces serum and salivary phosphorus levels .


[ corrected ] ClinicalTrials.gov NCT01039428 , 24 December , 2009 .


Dietary guidelines suggest limiting daily sodium intake to < 2,300 mg for the general population , and < 1,500 mg/d for those with certain cardiovascular risk factors .


Despite these recommendations , few Americans are able to achieve this goal .


Identifying challenges in meeting these guidelines is integral for successful compliance .


This analysis examined patterns and amount of daily sodium intake among participants with metabolic syndrome enrolled in a one-year dietary intervention study .


Two hundred forty participants with metabolic syndrome enrolled in a dietary intervention trial to lose weight and improve dietary quality .


Three 24-hour dietary recalls were collected at each visit which provided meal patterns and nutrient data , including sodium intake .


A secondary data analysis was conducted to examine sodium consumption patterns at baseline and at one-year study visits .


Sodium consumption patterns over time were examined using linear mixed models .


The percentage of meals reported eaten in the home at both baseline and one-year follow-up was approximately 69 % .


Follow-up for the one-year dietary intervention revealed that the participants who consumed sodium greater than 2,300 mg/d declined from 75 % ( at baseline ) to 59 % , and those that consumed higher than 1,500 mg/d declined from 96 % ( at baseline ) to 85 % .


Average sodium intake decreased from 2,994 mg at baseline to 2,558 mg at one-year ( P < 0.001 ) , and the sodium potassium ratio also decreased from 1.211 to 1.047 ( P < 0.001 ) .


Sodium intake per meal varied significantly by meal type , location , and weekday , with higher intake at dinner , in restaurants , and on weekends .


At-home lunch and dinner sodium intake decreased ( P < 0.05 ) , while dinner sodium intake at restaurant/fast food chains increased from baseline to one-year ( P < 0.05 ) .


Sodium intake for the majority of participants exceeded the recommended dietary guidelines .


Findings support actions that encourage low-sodium food preparation at home and encourage public health policies that decrease sodium in restaurants and prepared foods .


To investigate the clinical efficacy and safety of an additional core vitrectomy to the standard therapy in patients with exudative age-related macular degeneration ( ARMD ) .


In this prospective , controlled , single-centre study , 50 eyes of 50 patients ( mean age : 74.1 7.1 ; median 74 ( 69/78 ) ) with ARMD were enrolled and randomized 1:1 to group 1 - core vitrectomy additional to three times injections of ranibizumab ( 3x Rbz ) and Group 2 - 3x Rbz ( control ) .


1 16 of 25 eyes in Group 1 ( 64 % ) and 12 of 25 ( 48 % ) in Group 2 had a posterior vitreous detachment ( PVD ) prior to start of the study .


Changes in best-corrected visual acuity ( BCVA ) using ETDRS charts , central macular thickness and macular volume ( OCT ) as well as the rate of reinjection with an OCT-based pro renata ( PRN ) protocol were monitored prospectively over 48 weeks .


Forty-seven eyes completed follow-up at week 48 .


In Group 1 , 4 of 24 lost 1 line of BCVA ( 16.7 % ) and 3 of 24 lost 2 lines ( 12.5 % ) , whereas 17 of 24 gained more than 1 line ( 70.8 % ) and improved in average by 9.8 letters .


In Group 2 , 3 of 23 remained stable and 20 of 23 gained more than or exactly 1 line ( 78.3 % ) , resulting in 14.3 letters , with no loss of lines .


Central macular thickness decreased by 85.58 m ( 28.8 % ) in Group 1 and by 121.43 m ( 32.68 % ) in Group 2 compared with baseline .


In Group 1 , four patients received three additional and two patients , two additional Rbz injections .


In Group 2 , three patients received three additional , three patients two and 12 patients one additional Rbz injections .


This yielded in an average injection rate of 3.66 in Group 1 and 4.17 in Group 2 over 48 weeks .


Posterior vitreous detachment ( PVD ) was identified in Group 1 in 16 of 24 ( 66.7 % ) and in Group 2 in 12 of 23 ( 52.2 % ) patients at baseline .


At week 48 , 6 of 8 ( 75 % ) of the patients in Group 1 with initial attached vitreous showed a vitreal detachment , whereas only 1 of 11 ( 9 % ) in Group 2 had a new occurred detachment of the vitreous .


No systemic or ocular adverse events were noticed .


An initial core vitrectomy combined with a conventional ranibizumab injection regimen for exudative AMD patients was safe and lead to similar functional results with less intravitreal ranibizumab injections over 48 weeks .


The pharmacokinetic ( PK ) similarity between PF-05280014 , a proposed trastuzumab biosimilar , trastuzumab sourced from European Union ( trastuzumab-EU ) or from United States ( trastuzumab-US ) was evaluated .


Safety and immunogenicity were also assessed .


In this phase 1 , double-blind trial ( NCT01603264 ) , 105 healthy male volunteers were randomized 1:1:1 to receive a single 6mgkg ( -1 ) intravenous dose of PF-05280014 , trastuzumab-EU , or trastuzumab-US , and evaluated for 70 days .


Drug concentration-time data were analyzed by non-compartmental methods .


PK similarity for the comparisons of PF-05280014 to each of trastuzumab-EU and trastuzumab-US , and trastuzumab-EU to trastuzumab-US were determined using the standard 80.00 % to 125.00 % bioequivalence criteria .


Baseline demographics for the 101 subjects evaluable for PK were similar across all arms .


The three products exhibited similar PK profiles with target-mediated disposition .


The 90 % CIs for the ratios of Cmax , AUC ( 0 , t last ) and AUC ( 0 , ) were within 80.00 % to 125.00 % for all three pairwise comparisons .


Adverse events ( AEs ) were similar across all arms with treatment-related AEs reported by 71.4 % , 68.6 % and 65.7 % subjects in the PF-05280014 , trastuzumab-EU , and trastuzumab-US arms , respectively .


The most common AEs were infusion-related reactions , headache , chills , pyrexia and nausea .


The AE term ` pyrexia ' was numerically greater in the PF-05280014 arm .


All post-dose samples , except 1 , tested negative for anti-drug antibodies ( ADA ) .


This study demonstrates PK similarity among PF-05280014 , trastuzumab-EU and trastuzumab-US .


The safety and immunogenicity profiles observed for the three products in this study are consistent with previous reports for trastuzumab .


Dizziness is one of the most challenging symptoms in medicine .


No medication for dizziness in current use has well-established curative or prophylactic value or is suitable for long-term palliative use .


Unconventional remedies , such as acupuncture , should be considered and scientifically evaluated .


However , there has been relatively little evidence in randomized controlled clinical trials on acupuncture to treat chronic dizziness .


The aim of our study is to evaluate the efficacy and safety of acupuncture in patients with dizziness .


This trial is a randomized , single-blind , controlled study .


A total of 80 participants will be randomly assigned to two treatment groups receiving acupuncture and sham acupuncture treatment , respectively , for 4 weeks .


The primary outcome measures are the Dizziness Handicap Inventory ( DHI ) and the Vertigo Symptom Scale ( VSS ) .


Treatment will be conducted over a period of 4 weeks , at a frequency of two sessions per week .


The assessment is at baseline ( before treatment initiation ) , 4 weeks after the first acupuncture session , and 8 weeks after the first acupuncture session .


The results from this study will provide clinical evidence on the efficacy and safety of acupuncture in patients with chronic dizziness .


International Standard Randomized Controlled Trial Number Register : ISRCTN52695239 .


To investigate the clinical effect of negative pressure drainage after septum surgery .


One hundred and two cases with septum deviation were randomly divided into two groups , i. e. experimental group and controlling one .


With 51 cases in each .


Degree of comfort and complication of two groups were compared .


The cases in experimental group showed significantly relieved postoperative reaction with negative pressure drainage , when compared with that of controls , the incidence of complication were not increased .


Negative pressure drainage can be taken as one of the ideal materials for hemostasia after septum surgery .


To determine expression of apoptotic factors p53 and caspase-8 in human lens epithelial cells ( LECs ) of cataract patients with or without diabetic retinopathy ( DR ) , the duration of diabetes mellitus ( DM ) , and the level of glycated hemoglobin ( hemoglobin A1c [ HbA1c ] ) .


St. Mary 's Hospital , Catholic University of Korea , Seoul , South Korea .


Randomized prospective study .


The LECs were isolated during cataract surgery .


The isolated samples were classified into 4 groups as follows : patients without DM ( Group 1 ) , patients with DM but not DR ( Group 2 ) , diabetic patients with nonproliferative DR ( Group 3 ) , and diabetic patients with proliferative DR ( Group 4 ) .


To explore the mechanism of apoptosis , the expressions of p53 and caspase-8 were measured by immunohistochemical staining and compared with the data according to the duration of DM , HbA1c levels , and severity of DR.


All groups comprised 15 eyes .


The expressions of P53 and caspase-8 were higher in Groups 2 , 3 , and 4 than in Group 1 ( P < .001 ) .


The expressions were statistically significantly increased with a longer duration of DM , higher HbA1c levels , and advanced DR.


The expressions of P53 and caspase-8 were strong in patients with DM and advanced DR. Knowledge of these relationships may lead to a better understanding of the development of diabetic cataract .


No author has a financial or proprietary interest in any material or method mentioned .


To evaluate the effectiveness of nonnutritive sucking ( NNS ) and oral stimulation ( OS ) , either applied alone or in combination , to reduce the transition time from tube feeding to independent oral feeding .


Randomized controlled trial .


A 40-bed neonatal ICU in a university hospital in the People 's Republic of China .


A total of 120 preterm infants were admitted to the neonatal ICU from December 2012 to July 2013 .


Oral motor interventions .


One hundred twelve preterm infants were assigned to three intervention groups ( NNS , OS , and combined NNS + OS ) and one control group .


Primary outcome was the number of days needed from introduction of oral feeding to autonomous oral feeding ( transition time ) .


Secondary outcome measures were the rate of milk transfer ( mL/min ) , proficiency ( intake first 5 min/volume ordered ) , volume transfer ( volume transferred during entire feeding/volume prescribed ) , weight , and hospital length of stay .


Transition time was reduced in the three intervention groups compared with the control group ( p < 0.001 ) .


The milk transfer rate in the three intervention groups was greater than in the control group ( F3 ,363 = 15.37 ; p < 0.001 ) .


Proficiency in the NNS and OS groups did not exceed that in the control group while the proficiency in the NNS + OS group was greater than that in the control group at the stage when the infants initiated the oral feeding ( p = 0.035 ) .


Among all groups , no significant difference was found on weight gain and length of stay .


The combined NNS + OS intervention reduced the transition time from introduction to independent oral feeding and enhanced the milk transfer rate .


The combined intervention seems to have a beneficial effect on oral feeding proficiency in preterm infants .


Aromatase inhibitors ( AIs ) have been associated with decrements in patient-reported outcomes ( PROs ) .


The objective of this study was to assess whether real acupuncture ( RA ) , compared with sham acupuncture ( SA ) , improves PROs in patients with breast cancer who are receiving an adjuvant AI .


Postmenopausal women with a stage 0 through III breast cancer who received an AI and had treatment-associated musculoskeletal symptoms were randomized to receive 8 weekly RA versus SA in a dual-center , randomized controlled trial .


The National Surgical Adjuvant Breast and Bowel Project ( NSABP ) menopausal symptoms questionnaire , the Center for Epidemiological Studies Depression ( CESD ) scale , the Hospital Anxiety and Depression Scale ( HADS ) , the Pittsburgh Sleep Quality Index ( PSQI ) , the hot flash daily diary , the Hot Flash-Related Daily Interference Scale ( HFRDI ) , and the European quality-of-life survey ( EuroQol ) were used to assess PROs at baseline and at 4weeks , 8 weeks , and 12 weeks .


The intention-to-treat analysis included 23 patients in the RA arm and 24 patients in the SA arm .


There were no significant differences in baseline characteristics between the 2 groups .


Compared with baseline , scores in the RA arm improved significantly at week 8 on the CESD ( P = .022 ) , hot flash severity ( P = .006 ) , hot flash frequency ( P = .011 ) , the HFRDI ( P = .014 ) , and NSABP menopausal symptoms ( P = .022 ) ; scores in the SA arm improved significantly on the EuroQol ( P = .022 ) , the HFRDI ( P = .043 ) , and NSABP menopausal symptoms ( P = .005 ) .


Post-hoc analysis indicated that African American patients ( n = 9 ) benefited more from RA than SA compared with non-African American patients ( n = 38 ) in reducing hot flash severity ( P < .001 ) and frequency ( P < .001 ) scores .


Both RA and SA were associated with improvement in PROs among patients with breast cancer who were receiving AIs , and no significant difference was detected between arms .


Racial differences in response to acupuncture warrant further study .


To evaluate the effect of atomoxetine treatment on executive functions in young adults with attention-deficit/hyperactivity disorder ( ADHD ) .


In this Phase 4 , multi-center , double-blind , placebo-controlled trial , young adults ( 18-30 years ) with ADHD were randomized to receive atomoxetine ( 20-50 mg BID , N = 220 ) or placebo ( N = 225 ) for 12 weeks .


The Behavior Rating Inventory of Executive Function-Adult ( BRIEF-A ) consists of 75 self-report items within 9 nonoverlapping clinical scales measuring various aspects of executive functioning .


Mean changes from baseline to 12-week endpoint on the BRIEF-A were analyzed using an ANCOVA model ( terms : baseline score , treatment , and investigator ) .


At baseline , there were no significant treatment group differences in the percentage of patients with BRIEF-A composite or index T-scores 60 ( p > .5 ) , with over 92 % of patients having composite scores 60 ( 60 deemed clinically meaningful for these analyses ) .


At endpoint , statistically significantly greater mean reductions were seen in the atomoxetine versus placebo group for the BRIEF-A Global Executive Composite ( GEC ) , Behavioral Regulation Index ( BRI ) , and Metacognitive Index ( MI ) scores , as well as the Inhibit , Self-Monitor , Working Memory , Plan/Organize and Task Monitor subscale scores ( p < .05 ) , with decreases in scores signifying improvements in executive functioning .


Changes in the BRIEF-A Initiate ( p = .051 ) , Organization of Materials ( p = .051 ) , Shift ( p = .090 ) , and Emotional Control ( p = .219 ) subscale scores were not statistically significant .


In addition , the validity scales : Inconsistency ( p = .644 ) , Infrequency ( p = .097 ) , and Negativity ( p = .456 ) were not statistically significant , showing scale validity .


Statistically significantly greater improvement in executive function was observed in young adults with ADHD in the atomoxetine versus placebo group as measured by changes in the BRIEF-A scales .


ClinicalTrials.gov NCT00510276 .


In the general population , the epidemiological relationships between delirium and adverse outcomes are not well defined .


The aims of this study were to : ( 1 ) construct an algorithm for the diagnosis of delirium using the Geriatric Mental State ( GMS ) examination ; ( 2 ) test the criterion validity of this algorithm against mortality and dementia risk ; ( 3 ) report the age-specific prevalence of delirium as determined by this algorithm .


Participant and informant data in a randomly weighted subsample of the Cognitive Function and Ageing Study were taken from a standardized assessment battery .


The algorithmic definition of delirium was based on the DSM-IV classification .


Outcomes were : proportional hazard ratios for death ; odds ratios of dementia at 2-year follow-up .


Data from 2197 persons ( representative of 13,004 ) were used , median age 77 years , 64 % women .


Study-defined delirium was associated with a new dementia diagnosis at two years ( OR 8.82 , 95 % CI 2.76 to 28.2 ) and death ( HR 1.28 , 95 % CI 1.03 to 1.60 ) , even after adjustment for acute illness severity .


Similar associations were seen for study-defined subsyndromal delirium .


Age-specific prevalence as determined by the algorithm increased with age from 1.8 % in the 65-69 year age group to 10.1 % in the 85 age group ( p < 0.01 for trend ) .


For study-defined subsyndromal delirium , age-specific period prevalence ranged from 8.2 % ( 65-69 years ) to 36.1 % ( 85 years ) .


These results demonstrate the possibility of constructing an algorithmic diagnosis for study-defined delirium using data from the GMS schedule , with predictive criterion validity for mortality and dementia risk .


These are the first population-based analyses able to account prospectively for both illness severity and an earlier study diagnosis of dementia .


Secondary progressive multiple sclerosis , for which no satisfactory treatment presently exists , accounts for most of the disability in patients with multiple sclerosis .


Simvastatin , which is widely used for treatment of vascular disease , with its excellent safety profile , has immunomodulatory and neuroprotective properties that could make it an appealing candidate drug for patients with secondary progressive multiple sclerosis .


We undertook a double-blind , controlled trial between Jan 28 , 2008 , and Nov 4 , 2011 , at three neuroscience centres in the UK .


Patients aged 18-65 years with secondary progressive multiple sclerosis were randomly assigned ( 1:1 ) , by a centralised web-based service with a block size of eight , to receive either 80 mg of simvastatin or placebo .


Patients , treating physicians , and outcome assessors were masked to treatment allocation .


The primary outcome was the annualised rate of whole-brain atrophy measured from serial volumetric MRI .


Analyses were by intention to treat and per protocol .


This trial is registered with ClinicalTrials.gov , number NCT00647348 .


140 participants were randomly assigned to receive either simvastatin ( n = 70 ) or placebo ( n = 70 ) .