Updated survival analysis shows that SOX is similar to CapeOX , confirming the initial PFS analysis .


Therefore , the SOX regimen could be an alternative first-line doublet chemotherapy strategy for patients with metastatic colorectal cancer .


NCT00677443 and May 12 2008 .


Report long-term outcomes of the NOURISH randomized controlled trial ( RCT ) , which evaluated a universal intervention commencing in infancy to provide anticipatory guidance to first-time mothers on `` protective '' complementary feeding practices that were hypothesized to reduce childhood obesity risk .


The NOURISH RCT enrolled 698 mothers ( mean age 30.1 years , SD = 5.3 ) with healthy term infants ( 51 % female ) .


Mothers were randomly allocated to usual care or to attend two 6-session , 12-week group education modules .


Outcomes were assessed 5 times : baseline ( infants 4.3 months ) ; 6 months after module 1 ( infants 14 months ) ; 6 months after module 2 ( infants 2 years ) and at 3.5 and 5 years of age .


Maternal feeding practices were self-reported using validated questionnaires .


BMI Z-score was calculated from measured child height and weight .


Linear mixed models evaluated intervention ( group ) effect across time .


Retention at age 5 years was 61 % .


Across ages 2 to 5 years , intervention mothers reported less frequent use of nonresponsive feeding practices on 6 of 9 scales .


At 5 years , they also reported more appropriate responses to food refusal on 7 of 12 items ( Ps .05 ) .


No statistically significant group effect was noted for anthropometric outcomes ( BMI Z-score : P = .06 ) or the prevalence of overweight/obesity ( control 13.3 % vs intervention 11.4 % , P = .66 ) .


Anticipatory guidance on complementary feeding resulted in first-time mothers reporting increased use of protective feeding practices .


These intervention effects were sustained up to 5 years of age and were paralleled by a nonsignificant trend for lower child BMI Z-scores at all postintervention assessment points .


Dantrolene is neuroprotective in animal models and may attenuate cerebral vasospasm ( cVSP ) in human aneurysmal subarachnoid haemorrhage ( aSAH ) .


We evaluated safety , feasibility and tolerability of intravenous dantrolene ( IV-D ) in patients with aSAH .


In this single-centre , randomised , double blind , placebo-controlled trial , 31 patients with aSAH were randomised to IV-D 1.25 mg every 6h for 7days ( n = 16 ) or equiosmolar free water/5 % mannitol ( placebo ; n = 15 ) .


Primary safety end points were incidence of hyponatraemia ( sNa132mmol/L ) and liver toxicity ( proportion of patients alanine transaminase , aspartate aminotransferase and AlkPhos > 5 upper-limit-of-normal ) .


Secondary end points included tolerability , systemic hypotension and intracranial hypertension .


Efficacy was explored for clinical/radiological cVSP , delayed cerebral ischaemia ( DCI ) , and 3-month functional outcomes .


Quantitative analyses of angiograms and daily transcranial Doppler ( TCD ) were performed .


Between IV-D versus placebo , no differences were observed in the primary outcomes ( hyponatremia 44 % vs 67 % ( p = 0.29 ) ; liver toxicity 6 % vs 0 % ( p = 1.0 ) ) .


Three patients in the IV-D versus two in the placebo group had severe adverse events possibly attributable to infusion and reached stop criteria : one IV-D patient developed liver toxicity ; two patients in each group developed brain oedema requiring osmotherapy .


The majority of adverse events were not related to infusion ( 17 vs 5 ( RR 2.2 ; 95 % CI 0.7 to 6.7 ; p = 0.16 ) in IV-D vs placebo ) .


No differences in any categorical cVSP outcomes , DCI , 3-month outcomes or quantitative angiogram and TCD analyses were seen in this small safety trial not powered to detect efficacy .


In this small trial , IV-D after aSAH was feasible , tolerable and safe .


http://clinicaltrials.gov NCT01024972 .


Antithyroid drug therapy is one of the main medical treatments for Graves ' disease .


There have been conflicting reports as to whether the addition of exogenous L-thyroxine improves remission rates more than antithyroid drugs alone .


This randomized , controlled and prospective clinical trial was undertaken to investigate the long-term outcome of methimazole treatment with or without exogenous L-thyroxine in Chinese patients .


145 patients with Graves ' disease were randomly divided into 3 groups and all patients initially received 30mg of methimazole daily for at least 1 month and then followed the titration - regimen with or without L-thyroxine : group 1 ( 30mg20mg15mg10mg5mg ) ; group 2 ( 30mg20mg15mg10mg + L-thyroxine5mg + L-thyroxine ) ; group 3 ( 30mg20mg15mg10mg + L-thyroxine5mg + L-thyroxine2 .5 mg + L-thyroxine ) .


The drug therapy was discontinued after 5 months of the final dose .


16 out of 46 patients in group 1 ( 34.8 % ) , 12 out of 47 in group 2 ( 25.5 % ) and 16 out of 52 in group 3 ( 30.8 % ) had a recurrence of Graves ' disease within 6-year follow-up after drug withdrawal .


Survival Analysis showed no significant differences in the remission rates between any 2 groups , despite the remission rates in group 2 and 3 were slightly higher than that in group 1 .


The addition of L-thyroxine to methimazole treatment in patients with Graves ' disease neither improves nor prevents the remission or recurrence of Graves ' disease in China .


Effective treatment for hepatitis C virus ( HCV ) genotype 1 infection in patients who have not had a sustained virologic response to prior interferon-based therapy represents an unmet medical need .


We conducted a phase 3 , randomized , open-label study involving patients infected with HCV genotype 1 who had not had a sustained virologic response after treatment with peginterferon and ribavirin , with or without a protease inhibitor .


Patients were randomly assigned to receive the NS5A inhibitor ledipasvir and the nucleotide polymerase inhibitor sofosbuvir in a once-daily , fixed-dose combination tablet for 12 weeks , ledipasvir-sofosbuvir plus ribavirin for 12 weeks , ledipasvir-sofosbuvir for 24 weeks , or ledipasvir-sofosbuvir plus ribavirin for 24 weeks .


The primary end point was a sustained virologic response at 12 weeks after the end of therapy .


Among the 440 patients who underwent randomization and were treated , 20 % had cirrhosis and 79 % had HCV genotype 1a infection .


The rates of sustained virologic response were high in all treatment groups : 94 % ( 95 % confidence interval [ CI ] , 87 to 97 ) in the group that received 12 weeks of ledipasvir-sofosbuvir ; 96 % ( 95 % CI , 91 to 99 ) in the group that received 12 weeks of ledipasvir-sofosbuvir and ribavirin ; 99 % ( 95 % CI , 95 to 100 ) in the group that received 24 weeks of ledipasvir-sofosbuvir ; and 99 % ( 95 % CI , 95 to 100 ) in the group that received 24 weeks of ledipasvir-sofosbuvir and ribavirin .


No patient discontinued treatment owing to an adverse event .


The most common adverse events were fatigue , headache , and nausea .


Treatment with a once-daily , single-tablet regimen of ledipasvir and sofosbuvir resulted in high rates of sustained virologic response among patients with HCV genotype 1 infection who had not had a sustained virologic response to prior interferon-based treatment .


( Funded by Gilead Sciences ; ION-2 ClinicalTrials.gov number , NCT01768286 . )


We conducted a qualitative investigation of patients with type 2 diabetes to determine their perceived facilitators and barriers to exercise at multiple time points while enrolled in a randomized exercise trial including aerobic , resistance or combined exercise .


We explored differences in these themes over time , between intervention groups and by adherence level after intervention .


Interviews were conducted by telephone at 3 weeks ( run-in period ) , and at 3 ( midintervention ) , 6 ( end of intervention ) and 9 months ( maintenance ) after enrollment to assess factors that facilitated and hampered adherence to the exercise program .


Audiotapes were transcribed verbatim and subjected to content analysis .


Participants ( n = 28 ) with type 2 diabetes engaged in the interviews .


Social support from family and the trainer , future health benefits , a sense of well-being and perceived fitness improvements were exercise facilitators .


Experiencing illness or injury , work commitments and inclement weather were highlighted barriers .


A sense of well-being , fitness improvements and enjoyment frequently were expressed by participants assigned to the combined and resistance exercise conditions .


Participants who maintained prescribed exercise levels tended to be engaged in resistance exercise , and spoke of support from their personal trainers , the importance of strategies and enjoyment more frequently than those who did not maintain their exercise level .


Exercise maintainers also cited more facilitators ; no differences were found for barriers .


Patients with type 2 diabetes require social support , including continued contact with exercise specialists .


Patients need assistance with motivational enhancement and strategies to increase facilitators to maintain exercise behaviour .


Incorporating resistance exercise improves well-being and enjoyment-2 important factors linked to exercise maintenance .


Danshen ( Salvia miltiorrhiza ) and Gegen ( Radix puerariae ) ( D&G ) are two herbs frequently used for the treatment of angina and other cardiac symptoms in Chinese materia medica .


Recent studies have demonstrated their cardio-protective and anti-atherosclerosis effects .


Earlier we have conducted two clinical trials in 2004 and 2007 which demonstrated such effects in extremely high risk patients .


The aim of the study was to demonstrate the safety and effectiveness of D&G in the prevention of atherosclerosis in postmenopausal women with early hypercholesterolemia .


The study was designed as a randomized , double-blinded , placebo-controlled trial with a 12-month treatment period .


A population based sample of 165 postmenopausal women aged 47-65 were included in the trial .


Only women who experienced menopause for more than 12 months were recruited .


The eligible subjects were randomized to take the D&G preparation ( two capsules ) , or image-identical placebo capsules ( two capsules ) daily , in a double-blind and parallel fashion for 12 month .


The postmenopausal women with mild hypercholesterolemia ( mean age 56.5 4.1 of treatment group and 56.0 3.8 years of placebo group ) were randomized to the D&G group or placebo group for trial treatment .


Carotid intima-media thickness ( IMT ) was used as the surrogate marker and was measured using high resolution ultrasound .


Lipid profile was also tested .


Baseline characteristics were comparable between the two groups .


After 12 months , there were no significant changes in the blood pressures and general biochemical profiles in both groups , however , there was a remarkable decrease in serum low density lipoprotein ( LDL ) cholesterol ( -6.92 % ) and total cholesterol ( TC ) ( -5.85 % ) in the D&G group compared with the placebo group ( -3.21 % and -3.42 % ) when compared with the baseline .


The carotid intima-media thickness ( IMT ) decreased 1.52 % from baseline in the D&G group ( p < 0.004 ) but the decrease was only 1.13 % in the placebo treatment group ( p = 0.009 ) after 12 months treatment .


Twelve adverse events were reported ( six in placebo group and six in D&G group ) but none of them was directly relevant to the study herbal preparation .


Postmenopausal women with early hypercholesterolemia tolerated D&G well .


D&G improved the carotid intima thickness , lowered LDL and total cholesterol .


D&G therefore can be recommended for the prevention of atherosclerosis in postmenopausal women with hypercholesterolemia .


To investigate the effect of creatine ( CR ) supplementation on the acute interference induced by aerobic exercise on subsequent maximum dynamic strength ( 1RM ) and strength endurance ( SE , total number of repetitions ) performance .


Thirty-two recreationally strength-trained men were submitted to a graded exercise test to determine maximal oxygen consumption ( VO2max : 41.56 5.24 ml kg ( -1 ) min ( -1 ) ) , anaerobic threshold velocity ( ATv : 8.3 1.18 km h ( -1 ) ) , and baseline performance ( control ) on the 1RM and SE ( 4 80 % 1RM to failure ) tests .


After the control tests , participants were randomly assigned to either a CR ( 20 g day ( -1 ) for 7 days followed by 5 g day ( -1 ) throughout the study ) or a placebo ( PL-dextrose ) group , and then completed 4 experimental sessions , consisting of a 5-km run on a treadmill either continuously ( 90 % ATv ) or intermittently ( 1:1 min at vVO2max ) followed by either a leg - or bench-press SE/1RM test .


CR was able to maintain the leg-press SE performance after the intermittent aerobic exercise when compared with C ( p > 0.05 ) .


On the other hand , the PL group showed a significant decrease in leg-press SE ( p 0.05 ) .


CR supplementation significantly increased bench-press SE after both aerobic exercise modes , while the bench-press SE was not affected by either mode of aerobic exercise in the PL group .


Although small increases in 1RM were observed after either continuous ( bench press and leg press ) or intermittent ( bench press ) aerobic exercise in the CR group , they were within the range of variability of the measurement .


The PL group only maintained their 1RM .


In conclusion , the acute interference effect on strength performance observed in concurrent exercise may be counteracted by CR supplementation .


Nasogastric rehydration therapy ( NGRT ) is the recommended therapy in moderately dehydrated children with gastroenteritis and refusal to drink , since it is supposed to be as effective if not better than intravenous rehydration therapy ( IVRT ) .


However , in clinical practice IVRT is often favored .


We conducted a clinical trial to determine whether IVRT is not inferior to NGRT .


Children 3 months to 6 years of age with moderate dehydration and refusal to drink secondary to gastroenteritis were recruited .


After clinical assessment of the degree of dehydration , patients were assigned randomly to receive either IVRT or NGRT over 6h on the hospital ward .


Recruitment did not yield the estimated number of patients .


Mainly , non-enrollment was due to failure to obtain parental consent because IVRT was expected .


97 patients were enrolled in the study , 46 were randomized to NGRT and 51 to IVRT .


There was no difference between IVRT and NGRT groups concerning length of hospital stay ( 2.21.1 days vs. 2.41.1 days ) , success of rehydration ( 78 vs. 76 % ) and adverse events .


Since we had to terminate the study ahead of schedule due to a low recruiting rate , our results are not reliable .


However , data from the literature shows that the widespread described superiority of NGRT over IVRT is seriously influenced by studies from developing countries questioning the applicability of the results to a setting available in high-income countries nowadays .


Our study demonstrates the difficulties performing such a study in a high-income country to come to an objective and clearly evident final conclusion .


The aim of this study was to compare radiological results of total knee arthroplasties ( TKAs ) performed with patient-specific computed tomography ( CT ) - based instrumentation and conventional technique .


The main study hypothesis was that CT-based patient-specific instrumentation ( PSI ) increases the accuracy of TKA .


A prospective , randomized controlled trial was carried out between January and December 2011 .


A group of 112 patients who met the inclusion and exclusion criteria were enrolled in this study and randomly assigned to an experimental or control group .


The experimental group comprised 52 patients operated on with the aid of the Signature CT-based implant positioning system .


The control group consisted of 60 patients operated on using conventional instrumentation .


The radiographic evaluation of implant positioning and overall coronal alignment was performed 12 months after the surgery by using standing anteroposterior radiographs of the entire lower limb and standard lateral radiographs .


Of the 112 patients initially enrolled for the study , 95 were included in the subsequent analyses .


There were no statistically significant differences between groups in respect to coronal and sagittal component positioning and overall coronal alignment , except for frontal tibial component positioning .


For this parameter , better results were obtained in the control group , with borderline statistical significance .


Our study did not reveal superiority of the CT-based PSI system over conventional instrumentation .


Further high-quality investigations of patient-specific systems are absolutely indispensable to assess their utility for TKA .


In our opinion , the surgeon applying PSI technology is required to have advanced knowledge and considerable experience with the conventional method .


Previous studies on the prognostic value of clinical and MRI parameters for the time to return to play ( TTRTP ) in acute hamstring injuries showed only limited to moderate evidence for the various investigated parameters .


Some studies had multiple methodological limitations , including retrospective designs and the use of univariate analysis only .


The aim of this study was to assess the prognostic value of clinical and MRI parameters for TTRTP using multivariate analysis .


28 clinical and MRI parameters were prospectively investigated for an association with TTRTP in 80 non-professional athletes with MRI positive hamstring injuries undergoing a standardised rehabilitation programme .


The association between possible prognostic parameters and TTRTP was assessed with a multivariate linear regression model .


Parameters that had a p value < 0.2 on univariate testing were included in this model .


74 athletes were available for analysis .


A total of nine variables met the criteria for the multivariate analysis : intensity of sports , level of sports , self-predicted TTRTP by the athlete , length of discomfort on palpation , deficit in passive straight leg raise , pain score on isometric knee flexion , isometric knee flexion strength deficit and distance of the proximal pole of the MRI hyperintensity to the tuber ischiadicum .


Of these , only self-predicted TTRTP by the athlete and a passive straight leg raise deficit remained significantly associated with TTRTP after stepwise logistic regression .


The clinical parameters self-predicted TTRTP and passive straight leg raise deficit are independently associated with the TTRTP .


MRI parameters in grade 1 and 2 hamstring injuries , as described in the literature , are not associated with TTRTP .


For clinical practice , prognosis of the TTRTP in these injuries should better be based on clinical parameters .


Effective O2 delivery and accurate end-tidal CO2 ( ETCO2 ) sampling are essential features of nasal cannulae ( NCs ) in patients with compromised respiratory status .


We studied 4 NC designs : bifurcated nasal prongs ( NPs ) with O2 delivery and CO2 sensing in both NPs ( Hudson ) , separate O2/CO2 NPs ( Salter ) , and CO2 sensing in NPs with cloud O2 delivery outside the NPs via multi vents ( Oridion ) and dual vents ( Medline ) .


We hypothesized that design differences between NCs would influence O2 delivery and ETCO2 detection .


Forty-five healthy volunteers , 18 to 35 years , participated in an unrestricted , randomized block design , each subject serving as their own control in a 4-period crossover study design of 4 NCs during one session .


Monitoring included electrocardiogram , posterior pharynx O2 sampling from a Hauge Airway ( Sharn Anesthesia Products , Tampa , FL ) , and NC ETCO2 .


In 11 volunteers , radial artery blood was sampled from a catheter for partial pressures of O2 and carbon dioxide ( PaO2 and PaCO2 ) determination .


Per randomization , each NC was positioned , and data were collected over 2 minutes ( ETCO2 , pharyngeal O2 , PaO2 , and PaCO2 ) during room air and during O2 fresh gas flows ( FGFs ) of 2 , 4 , and 6 Lpm .


Statistical analyses were performed with SAS Analytics Pro , Version 9.3 , and JMP Statistical Software , Version 11 ( SAS Institute Inc. , Cary , NC ) , significance at P < 0.05 .


Blood gas analyses indicated PaCO2 during steady state at each experimental time period remained unchanged from physiologic baseline .


PaO2 did not differ between NC devices at baseline or 2 Lpm O2 .


The PaO2 at 4 Lpm from the separate NPs and bifurcated NCs was significantly higher than the multi-vented NC .


Pharyngeal O2 with the NC with separate NPs was significantly higher than multivented and dual-vented cloud delivery NCs at 2 , 4 , and 6 Lpm FGF .


Pharyngeal O2 with the NC with bifurcated NPs was significantly higher than the multi-vented NC at 2 Lpm , and higher than cloud delivery NCs at 4 and 6 Lpm FGF .


ETCO2 was significantly lower with the NC with bifurcated NPs compared to the other 3 NCs , consistent with errant CO2 tracings at higher FGF .


NCs provide supplemental inspired O2 concentrations for patients with impaired pulmonary function .


Accurate measures of ETCO2 are helpful in assessing respiratory rate and determining whether CO2 retention is occurring from hypoventilation .


These findings suggest the NC with separate NPs was the most effective in delivering O2 and the most consistent at providing reliable CO2 waveforms at higher FGFs .


Protein supplementation has been shown to reduce the increases in intrahepatic triglyceride ( IHTG ) content induced by acute hypercaloric high-fat and high-fructose diets in humans .


To assess the effect of a 12-wk iso-energetic high protein-low carbohydrate ( HPLC ) diet compared with an iso-energetic high carbohydrate-low protein ( HCLP ) diet on IHTG content in healthy non-obese subjects , at a constant body weight .


Seven men and nine women [ mean SD age : 24 5 y ; BMI : 22.9 2.1 kg/m2 ] were randomly allocated to a HPLC [ 30/35/35 % of energy ( En % ) from protein/carbohydrate/fat ] or a HCLP ( 5/60/35 En % ) diet by stratification on sex , age and BMI .


Dietary guidelines were prescribed based on individual daily energy requirements .


IHTG content was measured by 1H-magnetic resonance spectroscopy before and after the dietary intervention .


IHTG content changed in different directions with the HPLC ( CH2H2O : 0.23 0.17 to 0.20 0.10 ; IHTG % : 0.25 0.20 % to 0.22 0.11 % ) compared with the HCLP diet ( CH2H2O : 0.34 0.20 vs. 0.38 0.21 ; IHTG % : 0.38 0.22 % vs. 0.43 0.24 % ) , which resulted in a lower IHTG content in the HPLC compared with the HCLP diet group after 12 weeks , which almost reached statistical significance ( P = 0.055 ) .


A HPLC vs. a HCLP diet has the potential to preserve vs. enlarge IHTG content in healthy non-obese subjects at a constant body weight .


Clinicaltrials.gov NCT01551238 .


We compared the clinical efficacy of barium therapy and conservative therapy in preventing recurrence in patients with diverticular bleeding .


Previous case reports have indicated that barium impaction therapy provides initial hemostasis for diverticular bleeding and prevention against rebleeding .


After spontaneous cessation of bleeding , patients were randomly assigned to conservative treatment ( n = 27 ) or high-dose barium impaction therapy ( n = 27 ) .


Patients were followed up for 1 year after enrollment of the last patient .


The main outcome measure was rebleeding .


Median follow-up period was 584.5 days .


The probability of rebleeding at 30-day , 180-day , 1-year , and 2-year follow-up in all patients was 3.7 % , 14.8 % , 28.4 % , and 32.7 % , respectively .


By group , probability at 1 year was 42.5 % in the conservative group and 14.8 % in the barium group ( log-rank test , P = 0.04 ) .


After adjustment for a history of hypertension , the hazard ratio of rebleeding in the barium group was 0.34 ( 95 % confidence interval , 0.12-0 .98 ) .


No complications or laboratory abnormalities due to barium therapy were observed .


Compared with the conservative group , the barium group had significantly ( P < 0.05 ) fewer hospitalizations per patient ( 1.7 vs 1.2 ) , units of blood transfused ( 1.9 vs 0.7 ) , colonoscopies ( 1.4 times vs 1.1 times ) , and hospital stay days ( 15 days vs 11 days ) during the follow-up period .


No patients died and none required angiographic or surgical procedures in either group .


High-dose barium impaction therapy was effective in the long-term prevention of recurrent bleeding , and reduced the frequency of rehospitalization and need for blood transfusion and colonoscopic examination .


ClinicalTrials.gov Identifier , UMIN 000002832 .


Fiber intakes in developed countries are generally below those recommended by relevant authorities .


Given that many people consume fiber-depleted refined-grain products , adding functional fiber will help to increase fiber intakes .


The objective of the study was to determine metabolic and sensory effects of adding fiber to bread .


A double-blind pair of randomized crossover trials with a two-week washout in which two fiber-containing breads were compared with control bread .


The functional fiber ( fruit fiber and FibreMax ) was added to yield 10 g fiber per serve ( two slices ) .


Eighty participants ( n = 37 fruit fiber and n = 43 FibreMax ) consumed one serve of bread ( fiber or control ) followed three hours later by a pasta meal consumed ad libitum .


Outcome measures included glycemia , satiety , palatability , gastrointestinal wellbeing , visual appeal and subsequent energy intake of the pasta meal .


Multivariate regression was undertaken to test for differences between treatment and control for blood glucose , satiety , and cumulative energy intake .


Satiety responses were also compared by splitting the data into an immediate response after eating ( 0-30 min ) and a return to hunger analysis ( 30-180 min ) .


A Wilcoxon sign rank test was used for the first component ( 0-30 min ) and Wilcoxon matched-pairs signed-rank test for the second component ( 30-180 min ) .


Between treatment differences for gastrointestinal wellbeing were tested using Pearson 's chi-square test or Fisher 's exact test .


Consumption of the fruit fiber bread reduced postprandial glycemia by 35 % ( 95 % CI 13 to 51 ; P = 0.004 ) and cumulative energy intake by 368 kJ ( 95 % CI 163 to 531 ; P = 0.001 ) .


There was little influence on satiety and the bread was rated as having poor taste and smell whilst generating feelings of nausea in some participants .


FibreMax enriched bread reduced glycemia by 43 % ( 95 % CI 17 to 61 ; P = 0.004 ) without influence on energy intake or satiety .


Apart from a lower visual appeal , the FibreMax bread was palatable .


Neither bread caused gastrointestinal discomfort related to flatulence or bloating .


Enriching bread with 10 g of functional fiber per serve is feasible although reformulation is needed to create not only an acceptable bread , but a desirable product .


To investigate the efficacy and tolerability of albiglutide , a weekly glucagon-like peptide-1 receptor agonist , when added to metformin and glimepiride in a triple therapy regimen in people with type 2 diabetes mellitus .


This was a 156-week , randomized , double-blind , parallel-group , multicentre study .


In the present paper we describe the primary results , namely those at 52weeks .


Adult participants ( n = 685 ) were randomly assigned to albiglutide ( 30mg/week ) , pioglitazone ( 30mg/day ) or placebo .


If needed , blinded uptitration of albiglutide ( to 50mg/week ) and pioglitazone ( to 45mg/day ) was allowed .


The participant 's current dose of metformin ( > 1500mg/day ) was maintained throughout .


The glimepiride dose ( 4mg/day ) , standardized before randomization , could be decreased if persistent hypoglycaemia occurred .


The week 52 model-adjusted difference in change of glycated haemoglobin ( primary endpoint ) for albiglutide versus placebo was -0.87 [ 95 % confidence interval ( CI ) -1.07 , -0.68 ] % - units ( p < 0.001 ) , and for albiglutide versus pioglitazone it was 0.25 ( 95 % CI 0.10 , 0.40 ) % - units ; therefore , not non-inferior .


In the albiglutide group only , fasting plasma glucose reduced rapidly in the first 2weeks .


Confirmed hypoglycaemia occurred in 14 % of participants on albiglutide , 25 % on pioglitazone and 14 % on placebo .


The mean ( standard error ) weight change was -0.42 ( 0.2 ) kg with albiglutide , +4.4 ( 0.2 ) kg ( p < 0.001 ) with pioglitazone , and -0.40 ( 0.4 ) kg with placebo and serious adverse events occurred in 6.3 , 9.0 and 6.1 % of participants in the respective groups .


Injection site reactions occurred in 13 % of participants on albiglutide and resulted in treatment discontinuation for four participants ( 1.4 % ) .


Albiglutide , as part of triple therapy , provided effective glucose-lowering and was generally well tolerated .


Irritable bowel syndrome with diarrhoea ( IBS-D ) is particularly debilitating due to urgency and episodic incontinence .


Some 5-hydroxytryptamine 3 ( 5-HT3 ) receptor antagonists ( 5-HT3RAs ) have proven effective but have serious side effects .


Ondansetron , also a 5-HT3RA , has been widely used as an antiemetic with an excellent safety record for over two decades .


Our aim was to assess its effectiveness in IBS-D .


120 patients meeting Rome III criteria for IBS-D entered a randomised , double-blind , placebo-controlled crossover study of 5weeks of ondansetron 4mg versus placebo with dose titration allowed , up to two tablets three times daily in the first 3weeks .


Patients completed daily diaries documenting stool consistency using the Bristol Stool Form score .


Gut transit was measured in the last week of each treatment .


The primary endpoint was average stool consistency in the last 2weeks of treatment .


Ondansetron significantly improved stool consistency ( mean difference in stool form between ondansetron and placebo -0.9 , 95 % CI -1.1 to -0.6 , p < 0.001 ) .


Compared with placebo , patients on ondansetron experienced fewer days with urgency ( p < 0.001 ) , lower urgency scores ( p < 0.001 ) , reduced frequency of defaecation ( p = 0.002 ) and less bloating ( p = 0.002 ) , although pain scores did not change significantly .


IBS symptom severity score fell more with ondansetron than placebo ( 839.8 vs 379.7 , p = 0.001 ) .


65 % reported adequate relief with ondansetron but not placebo compared with 14 % reporting relief with placebo but not ondansetron , relative risk 4.7 , 95 % CI 2.6 to 8.5 , p < 0.001 .


Ondansetron relieves some of the most intrusive symptoms of IBS-D , namely loose stools , frequency and urgency .


Because many sports concussions happen during school-sponsored sports events , most state concussion laws specifically hold schools accountable for coach training and effective concussion management practices .


Brain 101 : The Concussion Playbook is a Web-based intervention that includes training in sports concussion for each member of the school community , presents guidelines on creating a concussion management team , and includes strategies for supporting students in the classroom .


The group randomized controlled trial examined the efficacy of Brain 101 in managing sports concussion .


Participating high schools ( N = 25 ) were randomly assigned to the Brain 101 intervention or control .


Fall athletes and their parents completed online training , and Brain 101 school administrators were directed to create concussion management policy and procedures .


Student athletes and parents at Brain 101 schools significantly outperformed those at control schools on sports concussion knowledge , knowledge application , and behavioral intention to implement effective concussion management practices .


Students who had concussions in Brain 101 schools received more varied academic accommodations than students in control schools .


Brain 101 can help schools create a comprehensive schoolwide concussion management program .


It requires minimal expenditures and offers engaging and effective education for teachers , coaches , parents , and students .


To evaluate the effects of canagliflozin , a sodium glucose co-transporter 2 inhibitor , on body weight in overweight and obese subjects ( body mass index [ BMI ] 27 and < 50 kg/m ( 2 ) ) .


This 12-week , Phase 2b , randomized , double-blind study enrolled 376 subjects without diabetes mellitus who received canagliflozin 50 , 100 , or 300 mg or placebo once daily .


The primary endpoint was the percent change in body weight from baseline through Week 12 .


Canagliflozin increased urinary glucose excretion in a dose-dependent manner and produced statistically significant reductions in body weight compared with placebo ( least squares mean percent changes from baseline of -2.2 % , -2.9 % , -2.7 % , and -1.3 % with canagliflozin 50 , 100 , and 300 mg and placebo ; P < 0.05 for all comparisons ) .


Overall adverse event ( AE ) rates were similar across groups .


Canagliflozin was associated with higher rates of genital mycotic infections in women , which were generally mild and led to few study discontinuations .


Osmotic diuresis-related AE rates were low and similar across groups .


In overweight and obese subjects without diabetes mellitus , canagliflozin significantly reduced body weight compared with placebo and was generally well tolerated .


There have been no data on sublingual immunotherapy ( SLIT ) in Brazilian patients sensitized to house dust mites .


This study aimed to evaluate the mucosal/systemic antibody response changes and clinical efficacy after SLIT using Dermatophagoides pteronyssinus ( Dpt ) allergens with or without bacterial extracts in mite-allergic Brazilian children .


Patients with allergic rhinitis and asthma were selected for a double-blind , placebo-controlled trial randomized to three groups : DPT ( Dpt extract , n = 34 ) , DPT+MRB ( Dpt plus mixed respiratory bacterial extracts , n = 36 ) , and Placebo ( n = 32 ) .


Total symptom and medication scores for rhinitis/asthma , skin prick test ( SPT ) to Dpt , and measurements of Dpt - , Der p 1 - , Der p 2-specific serum IgE , IgG4 , IgG1 , and specific salivary IgA were evaluated at baseline and after 12 and 18 months of treatment .


A significant long-term decline in total symptom/medication scores was observed only in active groups ( DTP and DPT+MRB ) .


There was no significant change in SPT results in all groups .


SLIT using Dpt allergen alone induced increased levels of serum IgG4 to Dpt , Der p 1 , and Der p 2 , serum IgG1 and salivary IgA to Dpt and Der p 1 .


SLIT with Dpt plus bacterial extracts was able to decrease IgE levels , particularly to Der p 2 , to increase salivary IgA levels to Der p 1 , but had no changes on specific IgG4 and IgG1 levels .


All children undergoing SLIT showed clinical improvement , but a long-term reduction in symptom/medication scores with modulation of mucosal/systemic antibody responses were seen only in active groups ( DPT and DPT+MRB ) .


The aim of this study was to test the hypothesis that intensive glycaemic control ( INT ) and higher plasma C-peptide levels in patients with poorly controlled diabetes would be associated with better eye outcomes .


The incidence and progression of diabetic retinopathy ( DR ) was assessed by grading seven-field stereoscopic fundus photographs at baseline and 5 years later in 858 of 1,791 participants in the Veterans Affairs Diabetes Trial ( VADT ) .


After adjustment for all covariates , risk of progression ( but not incidence ) of DR increased by 30 % for each 1 % increase in baseline HbA1c ( OR 1.3 ; 95 % CI 1.123 , 1.503 ; p = 0.0004 ) .


Neither assignment to INT nor age was independently associated with DR in the entire cohort .


However , INT showed a biphasic interaction with age .


The incidence of DR was decreased in INT participants 55 years of age ( OR 0.49 ; 95 % CI 0.24 , 1.0 ) but increased in those 70 years old ( OR 2.88 ; 95 % CI 1.0 , 8.24 ) ( p = 0.0043 ) .


The incidence of DR was reduced by 67.2 % with each 1 pmol/ml increment in baseline C-peptide ( OR 0.328 ; 95 % CI 0.155 , 0.7 ; p = 0.0037 ) .


Baseline C-peptide was also an independent inverse risk factor for the progression of DR , with a reduction of 47 % with each 1 pmol/ml increase in C-peptide ( OR 0.53 ; 95 % CI 0.305 , 0.921 ; p = 0.0244 ) .


Poor glucose control at baseline was associated with an increased risk of progression of DR. INT was associated with a decreased incidence of DR in younger patients but with an increased risk of DR in older patients .


Higher C-peptide at baseline was associated with reduced incidence and progression of DR.


The need for long preoperative fasting has been questioned .


Recent data shows that intake of an oral carbohydrate-containing clear fluid prior to anaesthesia is safe and may have a positive impact on recovery and metabolic status and could improve glucose tolerance .


Such solutions are routinely used in adults but not children .


The aim of this study was to evaluate the safety , tolerance and influence of oral carbohydrate on selected metabolic parameters in children .


With ethics committee approval and parental informed consent , 20 children , aged 4-17 years , ASA status I or II , scheduled for abdominal or thoracic surgery were randomised either to Group 1 - receiving a 12.6 % carbohydrate-containing drink ( 10 mL kg ( -1 ) the evening before surgery and two hours before anaesthesia ) , or the control Group 2 - fasting .


Serum glucose and insulin concentration were measured four times : before and after anaesthesia , in the evening after surgery , and the following morning .


IGF-1 concentration was measured once , before surgery .


Insulin resistance was assessed by the HOMA-IR equation .


Oral carbohydrate solution was well tolerated and no adverse events were noted .


Glucose concentrations were within the normal range in both groups .


Insulin concentration did not show significant differences between groups , however before surgery it tended to be lower in Group 1 .


Insulin resistance after surgery was significantly higher in Group 2 ( 2.0 vs. 0.62 , P = 0.03 ) , also the increase in insulin resistance after operation was significant only in the control group ( P = 0.03 ) .


Oral carbohydrates are safe , well tolerated and do not cause any perioperative adverse events .


They seem to improve postoperative metabolism by decreasing insulin resistance .


To investigate the effects of magnesium sulphate on succinylcholine-induced fasciculation in patients during the induction of general anaesthesia .


The double-blind randomised clinical trial was conducted in 2012 at Tohid and Besat Hospitals in Sanandaj , Iran , on patients who were candidates for surgery under general anaesthesia .


Patients were selected and divided into two equal groups of cases and controls using block randomisation .


The cases received magnesium sulphate , while the controls received normal saline .


SPSS 18 was used for statistical analysis .


Of the 100 subjects in the study , 49 ( 49 % ) were men and 51 ( 51 % ) were women ( p < 0.072 ) .


The mean age of the two groups were 37.5 12.2 years and 37.7 12 years ( p < 0.9 ) .


There was significant difference between the two groups in terms of the degree of fasciculation and muscle fasciculation ( p < 0.001 ) .


The difference between potassium levels in the two groups was not significant before anaesthesia ( p > 0.05 ) , but it was significant after anaesthesia ( p < 0.001 ) .


Magnesium sulphate can prevent and reduce the degree of fasciculation after anaesthesia .


Therefore it can be used to prevent fasciculation .


Schools provide a natural context to promote children 's mental health .


However , there is a need for more evidence-based , high quality school intervention programs combined with an accurate evaluation of their general effectiveness and effectiveness of specific intervention methods .


The aim of this paper is to present a study protocol of a cluster randomized controlled trial evaluating the `` Together at School '' intervention program .


The intervention program is designed to promote social-emotional skills and mental health by utilizing whole-school approach and focuses on classroom curriculum , work environment of school staff , and parent-teacher collaboration methods .


The evaluation study examines the effects of the intervention on children 's socio-emotional skills and mental health in a cluster randomized controlled trial design with 1 ) an intervention group and 2 ) an active control group .


Altogether 79 primary school participated at baseline .


A multi-informant setting involves the children themselves , their parents , and teachers .


The primary outcomes are measured using parent and teacher ratings of children 's socio-emotional skills and psychological problems measured by the Strengths and Difficulties Questionnaire and the Multisource Assessment of Social Competence Scale .


Secondary outcomes for the children include emotional understanding , altruistic behavior , and executive functions ( e.g. working memory , planning , and inhibition ) .


Secondary outcomes for the teachers include ratings of e.g. school environment , teaching style and well-being .


Secondary outcomes for both teachers and parents include e.g. emotional self-efficacy , child rearing practices , and teacher-parent collaboration .


The data was collected at baseline ( autumn 2013 ) , 6 months after baseline , and will be collected also 18 months after baseline from the same participants .


This study protocol outlines a trial which aims to add to the current state of intervention programs by presenting and studying a contextually developed and carefully tested intervention program which is tailored to fit a national school system .


Identification of effective intervention elements to promote children 's mental health in early school years is crucial for optimal later development .


ClinicalTrials.gov register : NCT02178332 .


Resuscitation is a life-saving measure usually instructed in simulation sessions .


Small-group teaching is effective .


However , feasible group sizes for resuscitation classes are unknown .


We investigated the impact of different group sizes on the outcome of resuscitation training .


Medical students ( n = 74 ) were randomized to courses with three , five or eight participants per tutor .


The course duration was adjusted according to the group size , so that there was a time slot of 6 minutes hands-on time for every student .


All participants performed an objective structured clinical examination before and after training .


The teaching sessions were videotaped and resuscitation quality was scored using a checklist while we measured the chest compression parameters with a manikin .


In addition , we recorded hands-on-time , questions to the tutor and unrelated conversation .


Results are displayed as median ( IQR ) .


Checklist pass rates and scores were comparable between the groups of three , five and eight students per tutor in the post-test ( 93 % , 100 % and 100 % ) .


Groups of eight students asked fewer questions ( 0.5 ( 0.0 - 1.0 ) vs. 3.0 ( 2.0 - 4.0 ) , p < .001 ) , had less hands-on time ( 2:16 min ( 1:15 - 4:55 min ) vs. 4:07 min ( 2:54 - 5:52 min ) , p = .02 ) , conducted more unrelated conversations ( 17.05.1 and 2.91.7 , p < 0.001 ) and had lower self-assessments than groups of three students per tutor ( 7.0 ( 6.1 - 9.0 ) and 8.2 ( 7.2 - 9.0 ) , p = .03 ) .


Resuscitation checklist scores and pass rates after training were comparable in groups of three , five or eight medical students , although smaller groups had advantages in teaching interventions and hands-on time .


Our results suggest that teaching BLS skills is effective in groups up to eight medical students , but smaller groups yielded more intense teaching conditions , which might be crucial for more complex skills or less advanced students .


Urinary tract infection is a key issue for long-term intermittent catheterization users .


Various catheter designs and methods have evolved to decrease the risk but the evidence remains unclear regarding whether product type improves outcomes .


We determined whether single use hydrophilic coated catheters reduced urinary tract infections compared to multiple use polyvinylchloride catheters for children with neurogenic bladder due to spina bifida .


This was a randomized crossover 4-center trial with 2 treatment periods of 24 weeks each , consisting of single use hydrophilic coated catheter and multiple use polyvinylchloride catheter ( washed with soap and water , and air dried after each use ) .


Each week participants recorded symptoms and urine results ( Multistix 8SG reagent strip ) .


Primary outcome was person-weeks of urinary tract infection , defined as positive leukocytes plus fever , flank pain , increased incontinence , malaise , or cloudy or odorous urine requiring antibiotic treatment .


Individuals were included if they were a child or young adult with spina bifida and used intermittent catheterization as the primary method of bladder emptying .


Calculated sample size was 97 .


More than 120 patients were screened , of whom 66 were randomized and 45 completed both trial arms .


Mean age was 10.6 years .


Of the patients 21 were male and 24 were female .


Mean SD person-weeks of urinary tract infection was 3.42 4.67 in the single use hydrophilic coated catheter group and 2.20 3.23 in the multiple use polyvinylchloride catheter group ( p < 0.001 ) .


There were no statistical differences in weeks of febrile urinary tract infection or antibiotic use .


Results are consistent with the Cochrane Review in that single use hydrophilic coated catheters may not decrease the incidence of symptomatic urinary tract infection in community dwelling chronic intermittent catheterization users when compared to clean multiple use polyvinylchloride catheters .


Due to the negative impact of radiation on the patient and the surgical team during percutaneous nephrolithotomy ( PCNL ) , we aimed to evaluate success rate and complications of blind access for PCNL using lumbar notch landmark and compare with conventional fluoroscopy-guided access .


In a clinical trial , 100 patients who were candidate for PCNL , were randomly assigned into blind group ( 1 ) and fluoroscopy-guided group ( 2 ) .


In group 1 the lumbar notch was used to guide percutaneous access and in group 2 fluoroscopy performed after needle insertion , Amplatz placement and at the end of surgery .


If the access failed , we would repeat puncturing up to 5 times .


In group 2 , access was achieved using full fluoroscopy guidance .


All patients underwent postoperative assessment including kidney-ureter-bladder X-ray and ultrasonography .


Both mean access time and mean operation time were statically similar in group 1 and group 2 ( 3.3 0.5 vs. 3.6 0.7 min and 35.2 4.6 vs. 38.9 4.1 min , respectively ) .


A successful puncture was achieved in 86 % and 94 % of the patients in groups 1 and 2 , respectively ( P = .18 ) .


Total success rate of procedure was 80 % and 88 % of the patients in groups 1 and 2 , respectively ( P = .27 ) .


According to this study , it seems that blind access is a safe and effective PCNL method , and we recommend employment of this technique by skilled endourologist in urology centers especially for patient with large hydronephrotic kidney .


To evaluate the effectiveness of the computerized CBT ( cCBT ) programme , MoodGYM , for the reduction in symptoms of general psychological distress ( the primary outcome ) , depression , anxiety , stress , and impaired daily functioning .


A randomized controlled trial , with a waiting list control condition , in a routine clinical setting .


Participants were 149 public mental health service users ( aged 18-61 [ M = 35.3 years ; SD = 10.3 ] ) waiting for interventions .


Self-report outcome measures were administered online at baseline and post-intervention ( i.e. , after 32 days ) .


After high dropout rates , a post-intervention completers analysis examined 28 MoodGYM participants and 38 waiting list control participants .


MoodGYM was significantly more effective than the waiting list control for the reduction of symptoms of general psychological distress ( F [ 1 , 64 ] = 4.45 ; p < .05 ) and stress ( F [ 1 , 64 ] = 5.35 ; p < .05 ) but not depression , anxiety , or impaired daily functioning .


Due to their high associated dropout rates , self-help cCBT programmes such as MoodGYM should not be provided as front-line treatments .


However , as it is likely to be agreeable and beneficial to some service users , perhaps self-help cCBT should be provided as an additional treatment option .


Single-centre series of the management of patients with ruptured abdominal aortic aneurysm ( AAA ) are usually too small to identify clinical factors that could improve patient outcomes .


IMPROVE is a pragmatic , multicentre randomized clinical trial in which eligible patients with a clinical diagnosis of ruptured aneurysm were allocated to a strategy of endovascular aneurysm repair ( EVAR ) or to open repair .


The influences of time and manner of hospital presentation , fluid volume status , type of anaesthesia , type of endovascular repair and time to aneurysm repair on 30-day mortality were investigated according to a prespecified plan , for the subgroup of patients with a proven diagnosis of ruptured or symptomatic AAA .


Adjustment was made for potential confounding factors .


Some 558 of 613 randomized patients had a symptomatic or ruptured aneurysm : diagnostic accuracy was 910 per cent .


Patients randomized outside routine working hours had higher operative mortality ( adjusted odds ratio ( OR ) 147 , 95 per cent confidence interval 100 to 217 ) .


Mortality rates after primary and secondary presentation were similar .


Lowest systolic blood pressure was strongly and independently associated with 30-day mortality ( 51 per cent among those with pressure below 70 mmHg ) .


Patients who received EVAR under local anaesthesia alone had greatly reduced 30-day mortality compared with those who had general anaesthesia ( adjusted OR 027 , 010 to 070 ) .


These findings suggest that the outcome of ruptured AAA might be improved by wider use of local anaesthesia for EVAR and that a minimum blood pressure of 70 mmHg is too low a threshold for permissive hypotension .


Conventional glucocorticoid replacement therapy fails to mimic the physiological cortisol rhythm , which may have implications for morbidity and mortality in patients with Addison 's disease .


The objective of the study was to compare the effects of continuous sc hydrocortisone infusion ( CSHI ) with conventional oral hydrocortisone ( OHC ) replacement therapy .


This was a prospective crossover , randomized , multicenter clinical trial comparing 3 months of treatment with thrice-daily OHC vs CSHI .


From Norway and Sweden , 33 patients were enrolled from registries and clinics .


All patients were assessed at baseline and after 8 and 12 weeks in each treatment arm .


The morning ACTH level was the primary outcome measure .


Secondary outcome measures were effects on metabolism , health-related quality of life ( HRQoL ) , sleep , and safety .


CSHI yielded normalization of morning ACTH and cortisol levels , and 24-hour salivary cortisol curves resembled the normal circadian variation .


Urinary concentrations of glucocorticoid metabolites displayed a normal pattern with CSHI but were clearly altered with OHC .


Several HRQoL indices in the vitality domain improved over time with CSHI .


No benefit was found for either treatments for any subjective ( Pittsburgh Sleep Quality Index questionnaire ) or objective ( actigraphy ) sleep parameters .


CSHI safely brought ACTH and cortisol toward normal circadian levels without adversely affecting glucocorticoid metabolism in the way that OHC did .


Positive effects on HRQoL were noted with CSHI , indicating that physiological glucocorticoid replacement therapy may be beneficial and that CSHI might become a treatment option for patients poorly controlled on conventional therapy .


Studies have suggested a link between diet and behavior in children with autism spectrum disorders ( ASDs ) .


Parental reports of behavioral changes upon exposure to gluten and/or casein are common in clinical practice .


An association between diet type , intestinal permeability ( IP ) ( ` leaky gut ' ) , and behavior has been long proposed but not substantiated .


We explored this possible association in this trial .


This randomized double-blind , placebo-controlled study explored the effects of gluten and milk on IP and behavior in children with ASDs over a period of 4 weeks .


IP assessed by lactulose : mannitol ( L/M ) sugar permeability test and behavior assessed by the Aberrant Behavior Checklist and Conners Parent Rating were measured .


Gastrointestinal symptoms in both groups were also monitored .


Neither the L/M ratio nor behavioral scores were different between groups exposed to gluten/dairy or placebo .


The changes observed were noted to be small and not clinically significant .


Our study although underpowered to show small differences does not support an association between dietary gluten/milk , IP , and behavioral changes in subjects with ASD .


Optimization of systolic blood pressure and lipid levels are essential for secondary prevention after ischemic stroke , but there are substantial gaps in care , which could be addressed by nurse - or pharmacist-led care .


We compared 2 types of case management ( active prescribing by pharmacists or nurse-led screening and feedback to primary care physicians ) in addition to usual care .


We performed a prospective randomized controlled trial involving adults with recent minor ischemic stroke or transient ischemic attack whose systolic blood pressure or lipid levels were above guideline targets .


Participants in both groups had a monthly visit for 6 months with either a nurse or pharmacist .


Nurses measured cardiovascular risk factors , counselled patients and faxed results to primary care physicians ( active control ) .


Pharmacists did all of the above as well as prescribed according to treatment algorithms ( intervention ) .


Most of the 279 study participants ( mean age 67.6 yr , mean systolic blood pressure 134 mm Hg , mean low-density lipoprotein [ LDL ] cholesterol 3.23 mmol/L ) were already receiving treatment at baseline ( antihypertensives : 78.1 % ; statins : 84.6 % ) , but none met guideline targets ( systolic blood pressure 140 mm Hg , fasting LDL cholesterol 2.0 mmol/L ) .


Substantial improvements were observed in both groups after 6 months : 43.4 % of participants in the pharmacist case manager group met both systolic blood pressure and LDL guideline targets compared with 30.9 % in the nurse-led group ( 12.5 % absolute difference ; number needed to treat = 8 , p = 0.03 ) .


Compared with nurse-led case management ( risk factor evaluation , counselling and feedback to primary care providers ) , active case management by pharmacists substantially improved risk factor control at 6 months among patients who had experienced a stroke .


ClinicalTrials.gov , no .


NCT00931788 .


The antibiotic rifaximin is used to treat non-constipated irritable bowel syndrome ( IBS ) .


Methane production is associated with constipation and its severity in constipation-predominant IBS ( C-IBS ) .


A previous retrospective study suggested that rifaximin and neomycin was superior to neomycin alone in improving symptoms in methane-positive subjects .


To determine the effectiveness of neomycin alone or with rifaximin in improving symptoms in methane-positive C-IBS subjects .


A double-blind , randomized , placebo-controlled trial was performed from 2010 to 2013 at three tertiary care centers .


Subjects aged 18-65 with C-IBS ( Rome II criteria ) and breath methane ( > 3ppm ) meeting the inclusion and exclusion criteria were recruited .


Subjects completed a baseline symptom questionnaire rating the severity of abdominal and bowel symptoms on a visual analog scale and were randomized to receive neomycin and placebo or neomycin and rifaximin for 14 days .


Symptom severity was assessed by weekly questionnaire for 2weeks of therapy and 4 additional weeks of follow-up .


Thirty-one subjects ( 16 neomycin and placebo , 15 neomycin and rifaximin ) were included in the intention-to-treat analysis .


Constipation severity was significantly lower in the neomycin and rifaximin group ( 28.630.8 ) compared to neomycin alone ( 61.224.1 ) ( P = 0.0042 ) , with greater improvement in constipation ( P = 0.007 ) , straining ( P = 0.017 ) and bloating ( P = 0.020 ) , but not abdominal pain .


In the neomycin and rifaximin group , subjects with methane < 3ppm after treatment reported significantly lower constipation severity ( 30.521.8 ) than subjects with persistent methane ( 67.232.1 ) ( P = 0.020 ) .


Rifaximin plus neomycin is superior to neomycin alone in improving multiple C-IBS symptoms .


This effect is predicted by a reduction in breath methane .


Stellate ganglion block ( SGB ) is effective for treatment of Bell 's palsy in patients with diabetes mellitus .


Corticosteroids are widely used for treatment of Bell 's palsy in patients with diabetes mellitus but may induce complications like hyperglycemia , which calls for an alternative therapy .


This study aimed to ascertain the effect of SGB on Bell 's palsy in patients with diabetes mellitus .


This randomized and single-blinded clinical trial involved 96 diabetic patients with Bell 's palsy that were randomly divided into a control group ( n = 48 ) and a treatment group ( SGB group , n = 48 ) .


The House-Brackmann scale and facial disability index ( FDI , including FDIP and FDIS ) were observed before treatment and at 1 and 3 months after treatment for assessment of the outcome .


No statistically significant difference was found between the two groups before treatment as regards the House-Brackmann scale and FDI .


There was a statistically significant difference in FDIP score in the two groups after treatment in comparison with before treatment .


The FDIS score showed a statistical difference between the two groups after treatment .


Glucose fluctuation often remains to be corrected under basal-supported oral therapy .


We investigated the efficacy of adding once-daily rapid-acting insulin in Japanese diabetes patients treated with basal-supported oral therapy .


In this 8-week , parallel-group , randomized , open-label trial , 62 Japanese adults with type 2 diabetes treated with insulin glargine and 50 mg of sitagliptin were randomized into the following two arms : the single-bolus group , in which once-daily insulin glulisine was initiated at a main meal at a fifth ( i.e. , 20 % ) the dose of insulin glargine , and the control group , in which the dose of sitagliptin was maximized to 100 mg .


The primary end point was the change of glycemic fluctuation assessed with the M-value .


Baseline hemoglobin A1c levels , mean blood glucose profiles , and M-value were 7.2 0.6 % , 9.3 1.7 mmol/L , and 21 13 units , respectively .


At the end of the study , the single-bolus group had a greater reduction of M-value than the control group ( P = 0.02 ) ; the difference was 6.5 units ( 95 % confidence interval , 1.1-11 .9 units ) .


The single-bolus group also had a greater reduction of mean blood glucose levels ( P = 0.01 ) .


There were no significant differences in the incidence of hypoglycemia or the weight change between the two groups ( P > 0.05 ) .


Adding once-daily insulin glulisine was more effective in controlling the glycemic fluctuation in Japanese type 2 diabetes patients treated with insulin glargine together with sitagliptin .


Although D2 lymphadenectomy has been shown to improve outcomes in gastric cancer , it may increase postoperative morbidity , mainly owing to splenopancreatic complications .


In addition , the effects of nodal dissection along the proper hepatic artery have not been extensively elucidated .


We hypothesized that modified D2 ( ie , D1 + ) lymphadenectomy may decrease surgical risks without impairing oncologic adequacy .


Patients with node-positive gastric cancer undergoing curative total gastrectomy were intraoperatively randomized to D1 + ( group 1 , 36 patients ) or standard D2 lymphadenectomy ( group 2 , 37 patients ) , the latter including splenectomy and nodal group 12a .


The index of estimated benefit was used to assess the efficacy of dissection of each nodal station .


The primary endpoint for oncologic adequacy was the disease-free survival ( DFS ) rate .


Surgical complications were significantly more common in group 2 , which also included 2 postoperative deaths .


Overall , 35 patients ( 49 % ) experienced tumor recurrence .


The primary site of tumor relapse and the 5-year DFS rate were not different between the 2 groups .


Involvement of the second nodal level was associated with a worse DFS rate ; however , patients undergoing more extensive lymphadenectomy did not show a better DFS rate .


The incidence of involvement of nodal stations 10 , 11d , and 12a was 5 % , and the 5-year DFS rate was zero .


Consequently , the benefit to dissect such lymph nodes was null .


These findings suggest that modified D2 lymphadenectomy confers the same oncologic adequacy as standard D2 lymphadenectomy , with a significant reduction of postoperative morbidity .


To demonstrate the safety and effectiveness of responsive stimulation at the seizure focus as an adjunctive therapy to reduce the frequency of seizures in adults with medically intractable partial onset seizures arising from one or two seizure foci .


Randomized multicenter double-blinded controlled trial of responsive focal cortical stimulation ( RNS System ) .


Subjects with medically intractable partial onset seizures from one or two foci were implanted , and 1month postimplant were randomized 1:1 to active or sham stimulation .


After the fifth postimplant month , all subjects received responsive stimulation in an open label period ( OLP ) to complete 2years of postimplant follow-up .


All 191 subjects were randomized .


The percent change in seizures at the end of the blinded period was -37.9 % in the active and -17.3 % in the sham stimulation group ( p = 0.012 , Generalized Estimating Equations ) .


The median percent reduction in seizures in the OLP was 44 % at 1year and 53 % at 2years , which represents a progressive and significant improvement with time ( p < 0.0001 ) .


The serious adverse event rate was not different between subjects receiving active and sham stimulation .


Adverse events were consistent with the known risks of an implanted medical device , seizures , and of other epilepsy treatments .


There were no adverse effects on neuropsychological function or mood .


Responsive stimulation to the seizure focus reduced the frequency of partial-onset seizures acutely , showed improving seizure reduction over time , was well tolerated , and was acceptably safe .


The RNS System provides an additional treatment option for patients with medically intractable partial-onset seizures .


Cognitive impairment develops with pre-diabetes and dementia is a complication of diabetes .


Natural products like turmeric and cinnamon may ameliorate the underlying pathogenesis .


People 60 years ( n = 48 ) with newly-recognised untreated pre-diabetes were randomised to a double-blind metabolic study of placebo , turmeric ( 1 g ) , cinnamon ( 2 g ) or both ( 1 g & 2 g respectively ) , ingested at a white bread ( 119 g ) breakfast .


Observations were made over 6 hours for pre - and post-working memory ( WM ) , glycaemic and insulin responses and biomarkers of Alzheimer 's disease ( AD ) ( 0 , 2 , 4 and 6 hours ) : amyloid precursor protein ( APP ) , - secretase subunits presenilin-1 ( PS1 ) , presenilin-2 ( PS2 ) , and glycogen synthase kinase ( GSK-3 ) .


Differences between natural product users and non-users were determined by Students t and chi square tests ; and between pre-test and post-test WM by Wilcoxon signed rank tests .


Interaction between turmeric and cinnamon was tested by 2-way ANOVA .


Multivariable linear regression ( MLR ) took account of BMI , glycaemia , insulin and AD biomarkers in the WM responses to turmeric and cinnamon .


No interaction between turmeric and cinnamon was detected .


WM increased from 2.6 to 2.9 out of 3.0 ( p = 0.05 ) with turmeric , but was unchanged with cinnamon .


WM improvement was inversely associated with insulin resistance ( r = -0.418 , p < 0.01 ) , but not with AD biomarkers .


With MLR , the WM responses to turmeric were best predicted with an R2 of 34.5 % ; and with significant turmeric , BMI and insulin/glucose AUC beta-coefficients .


Co-ingestion of turmeric with white bread increases working memory independent of body fatness , glycaemia , insulin , or AD biomarkers .


To compare the bowel cleansing efficacy of same day ingestion of 4-L sulfa-free polyethylene glycol ( 4-L SF-PEG ) vs 2-L polyethylene glycol solution with ascorbic acid ( 2-L PEG + Asc ) in patients undergoing afternoon colonoscopy .


206 patients ( mean age 56.7 years , 61 % male ) undergoing outpatient screening or surveillance colonoscopies were prospectively randomized to receive either 4-L SF-PEG ( n = 104 ) or 2-L PEG + Asc solution ( n = 102 ) .


Colonoscopies were performed by two blinded endoscopists .


Bowel preparation was graded using the Ottawa scale .


Each participant completed a satisfaction and side effect survey .


There was no difference in patient demographics amongst groups .


4-L SF-PEG resulted in better Ottawa scores compared to 2-L PEG + Asc , 4.2 vs 4.9 ( P = 0.0186 ) ; left colon : 1.33 vs 1.57 respectively ( P = 0.0224 ) , right colon : 1.38 vs 1.63 respectively ( P = 0.0097 ) .


No difference in Ottawa scores was found for the mid colon or amount of fluid .


Patient satisfaction was similar for both arms but those assigned to 4-L SF-PEG reported less bloating : 23.1 % vs 11.5 % ( P = 0.0235 ) .


Overall polyp detection , adenomatous polyp and advanced adenoma detection rates were similar between the two groups .


Morning only 4-L SF-PEG provided superior cleansing with less bloating as compared to 2-L PEG + Asc bowel preparation for afternoon colonoscopy .


Thus , future studies evaluating efficacy of morning only preparation for afternoon colonoscopy should use 4-L SF-PEG as the standard comparator .


Type B influenza virus is a major epidemic strain responsible for considerable mortality and morbidity .


A colloidal gold immunochromatographic strip for the rapid detection of human influenza B virus was developed .


This test is based on membrane chromatography and uses colloidal gold conjugated with influenza B virus anti-NP monoclonal antibody as the tracer .


The assembled test strip was housed in a plastic case .


The colloid gold strip ( CGS ) specifically detected all influenza B viruses tested and did not react with other respiratory viruses .


Compared with SYBR Green real-time PCR , the sensitivity and specificity of the CGS test was 89.76 % and 99.56 % , respectively , and the consistency ratio between CGS and real-time PCR was 96.06 % in detecting influenza B virus in 710 nasopharyngeal swabs from patients with influenza-like illness in the hospital .


The CGS array developed in this study enabled typing of influenza B viruses in human clinical specimens .


Thus , together with the advantages of rapid detection and easy operation without requiring specialized personnel and equipment , this technique is a convenient and relatively inexpensive diagnostic tool for large-scale screening of clinical samples .


Minimally invasive techniques commonly are applied to mitral valve surgery ; however , there has been little research investigating the optimal methods of cardiopulmonary bypass for the right minithoracotomy approach .


Controversy exists as to whether a percutaneous superior vena cava drainage cannula ( PSVC ) is necessary during these operations .


The authors , therefore , sought to determine the effect of using a percutaneous superior vena cava catheter on brain near-infrared spectroscopy , blood lactate levels , hemodynamics and surgical parameters .


Randomized , blinded , crossover trial .


Tertiary care university hospital .


Patients undergoing minimally invasive mitral valve surgery via a right minithoracotomy .


Twenty minutes of either clamped or unclamped percutaneous superior vena cava neck catheter drainage , during mitral valve repair .


For the primary outcome of brain near-infrared spectroscopy , there were no differences between the two groups ( percutaneous superior vena cava clamped 55.0 % 11.6 % versus unclamped 56.1 % 10.2 % ) ( p = 0.283 ) .


For the secondary outcomes pH ( clamped 7.350.05 versus unclamped 7.370.05 p = 0.015 ) , surgical score ( clamped 1.961.14 versus unclamped 1.220.51 p = 0.002 ) and CVP ( clamped 11.6 mmHg4 .8 mmHg versus unclamped 6.1 mmHg6 .1 mmHg p < 0.001 ) were significantly different .


The use of a percutaneous superior vena cava drainage improved surgical visualization and lowered CVP , but had no effect on brain near infrared spectroscopy during minimally invasive mitral valve surgery .


( ClinicalTrials.gov Identifier : NCT01166841 ) .


A new gel formulation containing loteprednol etabonate ( LE ) , a C-20 ester corticosteroid used to treat ocular inflammation , was developed to provide increased retention on the ocular surface for improved drug delivery to intraocular tissues .


This investigation evaluated concentrations of LE in tear fluid following topical instillation of LE gel to humans and the ocular and systemic pharmacokinetics of LE following administration to rabbits .


LE ophthalmic gel 0.5 % was administered as a single topical dose to human volunteers ( n = 12 ) and Dutch Belted rabbits ( n = 40 ) .


In the human study , tear sampling was performed at 6 , 9 , 12 , and 24h after instillation .


In the rabbit study , tears and ocular tissues were collected from 5min through 24h postdose .


Serial blood samples were collected from one cohort of rabbits for plasma analysis .


Concentrations of LE were determined by high performance liquid chromatography tandem mass spectrometry .


In humans , LE was detected in tears at all the time points assessed with mean concentrations of 114g/g at 6h declining to 2.41 g/g at 24h postdose .


In rabbits , LE was detected in all ocular tissues within 5min after dosing .


Maximum concentrations of LE were achieved within 0.5 h and were highest in tear fluid ( 1560g/g ) , followed by bulbar conjunctiva ( 4.03 g/g ) , cornea , ( 2.18 g/g ) , iris/ciliary body ( 0.162 g/g ) , and aqueous humor ( 0.0138 g/mL ) .


LE remained measurable in all ocular tissues through 24h with the exception of aqueous humor .


In contrast , plasma levels of LE were low with no detectable levels after 4h .


The gel formulation of LE provided prolonged exposure to LE on the ocular surface , with measurable levels in tears through 24h in both humans and rabbits , for delivery of LE to anterior segment tissues , as evidenced by sustained levels of LE in rabbit conjunctiva , cornea , and iris/ciliary body .


Long Acting Reversible Contraception ( LARC ) methods are highly effective in reducing the incidence of unwanted pregnancy .


Recent data indicates that the rate of abortion in Grampian , North East of Scotland is above the Scottish average and LARC uptake among young women low .


This study sought to explore young women 's perceptions of LARC , with the aim of developing a strategy to increase LARC uptake .


Qualitative study .


Sixty five women aged 16-24 were randomly recruited to this qualitative study from community centres and shopping areas .


Recruitment and interviews were conducted in friendship pairs , triads or one-to-one basis .


Participants were asked about current and past contraception use , views of contraception methods including LARC ; and sources of information about contraception .


Data were analysed using thematic content analysis .


Women interviewed were aware of some of the delivery systems used for long acting contraception ( intrauterine devices , implants and injections ) but did not recognise them as ` LARC ' .


` Long acting ' was equated with permanency and the term ` reversible ' appeared to have the opposite effect to its intention .


Intrauterine devices were commonly referred to as ` coil ' .


The women often relied on verbal testimonies from those who had experienced using LARC , many of which were negative and inaccurate .


A lack of in-depth knowledge about LARC and the opinion that LARC methods were for older women were also cited as barriers to use .


This study shows that negative testimonies and the belief that LARC are not appropriate for young women may discourage LARC uptake .


Epidural injections are performed to manage lumbar central spinal stenosis pain utilizing caudal , interlaminar , and transforaminal approaches .


The literature on the efficacy of epidural injections in managing lumbar central spinal stenosis pain is sparse ; lacking multiple , high quality randomized trials with long-term follow-up .


Two randomized controlled trials of the caudal and lumbar interlaminar approaches that assessed 220 patients with lumbar central spinal stenosis were analyzed .


The analysis found efficacy for both caudal and interlaminar approaches in managing chronic pain and disability from central spinal stenosis was demonstrated .


In the patients responsive to treatment , those with at least 3 weeks of improvement with the first 2 procedures , 51 % reported significant improvement with caudal epidural injections , whereas it was 84 % with local anesthetic only with interlaminar epidurals , 57 % with caudal and 83 % with lumbar interlaminar with local anesthetic with steroid .


The response rate was 38 % with caudal and 72 % with lumbar interlaminar with local anesthetic only and 44 % with caudal and 73 % with lumbar interlaminar with local anesthetic with steroid when all patients were considered .


In the interlaminar approach , results were superior for pain relief and functional status with fewer nonresponsive patients compared to the caudal approach .


The data was derived from 2 previously published randomized , controlled trials rather than comparing 2 techniques in one randomized controlled trial .


Further , the randomized controlled trials were active control trials without a placebo .


The results of this assessment showed significant improvement in patients suffering with chronic lumbar spinal stenosis with caudal and interlaminar epidural approaches with local anesthetic only , or with steroids in a long-term follow-up of up to 2 years , in contemporary interventional pain management setting , with the interlaminar approach providing significantly better results .


Scope of practice in audiology encompasses proficiency in visual inspection of ear canal and tympanic membrane ( TM ) as well as otoscopy interpretation skills to determine normal versus abnormal conditions of outer and middle ear .


Audiology students can develop skills in otoscopy through education and supervised training .


Studies have shown that additional otoscopy training increased skills in medical students and general practitioners .


However , educational and supervised practices targeting otoscopy competency during audiology graduate coursework are lacking .


Also , no studies have attempted to determine otoscopy skills among audiology students .


To determine the effectiveness of the otoscopy training model on clinical competency and confidence level of audiology students in performing and interpreting otoscopy .


A combination of experimental treatment design with random assignment of treatment and control groups and delayed treatment for control group .


Thirty-two first - and second-year audiology graduate students who were enrolled in a pediatric audiology class participated in this study .


Students were randomly assigned to the control ( n = 16 , 14 females ) or experimental ( n = 16 , 14 females ) group .


Participants in the experimental group received supplementary otoscopy training including didactic otoscopy lectures as well as clinical training using manikin ears .


The control group received the same pretest and posttest and then completed a third assessment ( posttest 2 ) after receiving the same training .


An evaluation of knowledge and skills regarding otoscopy between groups and time was conducted at three times : ( a ) pretraining , ( b ) upon completion of training for the experimental group , ( c ) upon completion of training by the control group .


The evaluation consisted of a written exam , a clinical exam , and a self-perception rating of confidence .


Both written exam scores and clinical exam scores ( otoscopy manikin ) were analyzed via two-way analyses of variance ( ANOVAs ) , whereas chi-square ( ) statistic was conducted to evaluate the effects of training on the confidence level of students of both groups .


Experimental and control groups demonstrated significant increased overall competency in otoscopy following the otoscopy training model with didactic and laboratory components .


Posttest confidence ratings showed increases in all groups , and there were no significant differences between groups .


The need for supplementary otoscopy training was warranted by low knowledge and clinical competency in otoscopy skills of audiology students as measured by pretest mean scores .


After completing the training , both experimental and control groups showed significant improvement in knowledge and competency .


Results also suggest that perceived confidence ratings may be misleading in determining students ' clinical otoscopy skills .


Acceptance of healthcare-associated pneumonia ( HCAP ) as an entity and the associated risk of infection by potentially multidrug-resistant ( MDR ) organisms such as methicillin-resistant Staphylococcus aureus ( MRSA ) , Pseudomonas and Acinetobacter have been debated .


We therefore compared patients with HCAP , hospital-acquired pneumonia ( HAP ) , and ventilator-associated pneumonia ( VAP ) enrolled in a trial comparing linezolid with vancomycin for treatment of pneumonia .


The analysis included all patients who received study drug .


HCAP was defined as pneumonia occurring < 48hours into hospitalization and acquired in a long-term care , subacute , or intermediate health care facility ; following recent hospitalization ; or after chronic dialysis .


Data from 1184 patients ( HCAP = 199 , HAP = 379 , VAP = 606 ) were analyzed .


Compared with HAP and VAP patients , those with HCAP were older , had slightly higher severity scores , and were more likely to have comorbidities .


Pseudomonas aeruginosa was the most common gram-negative organism isolated in all pneumonia classes [ HCAP , 22/199 ( 11.1 % ) ; HAP , 28/379 ( 7.4 % ) ; VAP , 57/606 ( 9.4 % ) ; p = 0.311 ] .


Acinetobacter spp .


were also found with similar frequencies across pneumonia groups .


To address potential enrollment bias toward patients with MRSA pneumonia , we grouped patients by presence or absence of MRSA and found little difference in frequencies of Pseudomonas and Acinetobacter .


In this population of pneumonia patients , the frequencies of MDR gram-negative pathogens were similar among patients with HCAP , HAP , or VAP .


Our data support inclusion of HCAP within nosocomial pneumonia guidelines and the recommendation that empiric antibiotic regimens for HCAP should be similar to those for HAP and VAP .


The higher risk of adverse outcomes after transapical ( TA ) versus transfemoral ( TF ) transcatheter aortic valve replacement ( TAVR ) could be attributable to TA-TAVR being an open surgical procedure or to clinical differences between TA - and TF-TAVR patients .


We compared outcomes after neutralizing patient differences using propensity score matching .


From April 2007 to February 2012 , 1100 Placement of Aortic Transcatheter Valves ( PARTNER ) - I patients underwent TA-TAVR and 1521 underwent TF-TAVR with Edwards SAPIEN balloon-expandable bioprostheses .


Propensity matching based on 111 preprocedural variables , exclusive of femoral access morphology , identified 501 well-matched patient pairs ( 46 % of possible matches ) , 95 % of whom had peripheral arterial disease .


Matched TA-TAVR patients experienced more adverse procedural events , longer length of stay ( 5 versus 8 days ; P < 0.0001 ) , and slower recovery ( New York Heart Association class I , 31 % versus 38 % at 30 days , equalizing by 6 months at 51 % versus 47 % ) ; stroke risk was similar ( 3.4 % versus 3.3 % at 30 days and 6.0 % versus 6.7 % at 3 years ) ; mortality was elevated for the first 6 postprocedural months ( 19 % versus 12 % ; P = 0.01 ) ; but aortic regurgitation was less ( 34 % versus 52 % mild and 8.9 % versus 12 % moderate to severe at discharge , P = 0.001 ; 36 % versus 50 % mild and 10 % versus 15 % moderate to severe at 6 months , P < 0.0001 ) .


The likelihood of adverse periprocedural events and prolonged recovery is greater after TA-TAVR than TF-TAVR in vasculopathic patients after accounting for differences in cardiovascular risk factors , although stroke risk is equivalent and aortic regurgitation is less .


As smaller delivery systems permit TF-TAVR in many of these patients , we recommend a TF-first access strategy for TAVR when anatomically feasible .


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


Unique identifier : NCT00530894 .


The most dreaded hemorrhagic complication in endoscopic endonasal surgery is injury to the internal carotid artery ( ICA ) .


Although a number of treatment protocols are currently used , none have been formally investigated .


This study aims to compare the efficacy of the muscle patch , bipolar diathermy , and aneurysm clip on hemostasis , pseudoaneurysm formation , and long-term vessel patency for different injury types in a sheep model of carotid bleeding .


Twenty-seven sheep underwent ICA dissection/isolation followed by the artery placement within a modified `` sinus model otorhino neuro trainer '' ( SIMONT ) model .


Standardized linear , punch , and stellate injuries were made .


Randomization of sheep to receive 1 of 3 hemostatic techniques was performed ( muscle , bipolar , clip ) .


Specific outcome measures included attainment of primary hemostasis , time to hemostasis , blood loss , pseudoaneurysm formation , and carotid patency on follow-up magnetic resonance imaging ( MRI ) .


Bipolar achieved primary hemostasis in 7 of 9 cases and 2 cases of secondary hemorrhage .


It had no associated pseudoaneurysm formation .


Carotid patency was variable on follow-up MRI .


Muscle patch achieved 100 % primary hemostasis with 2 cases of secondary hemorrhage .


There were 2 cases of pseudoaneurysm and 100 % patency rate on follow-up MRI .


Aneurysm clip achieved 100 % primary hemostasis with 1 case of secondary hemorrhage .


No pseudoaneurysm formation and a 50 % rate of carotid insufficiency on MRI .


This study shows that the crushed muscle patch and aneurysm clip can be viable options in the management of ICA injury with short-term and long-term benefits .


Complications associated with these techniques were comparable if not reduced when compared to the published literature .


The hemostatic and inflammatory systems may activate each other .


Endometriosis is a chronic inflammatory disease affecting 10 % of women .


The objective of this study was to compare the hemostatic effects of two treatments widely prescribed to women with endometriosis : the levonorgestrel intrauterine system ( LNG-IUS ) and the gonadotropin-releasing hormone analog ( GnRHa ) leuprolide acetate .


In this randomized open-label controlled trial , 44 women with endometriosis were randomly allocated to one of two groups : 22 women were assigned to use LNG-IUS and 22 to use GnRHa .


The assessed variables were D-dimers , fibrinogen , prothrombin time , activated partial thromboplastin time , coagulation factors ( F ) II , V , VII , VIII , IX , X , and XI , antithrombin ( AT ) , protein C , free protein S , tissue plasminogen activator ( t-PA ) , 2-antiplasmin , thrombin-antithrombin complex , and prothrombin fragment 1 +2 .


All variables were assessed before treatment and six months after treatment onset .


In the LNG-IUS group , FVIII decreased 10 % after six months of use .


In the GnRHa group , there was a 6 % increase in AT , 29 % reduction in D-dimers , and 19 % increase in t-PA .


The LNG-IUS users exhibited a significantly greater reduction of FVIII than the GnRHa users ( LNG-IUS : -6.4 14.3 % vs. GnRHa : 4.2 12.3 % , p = 0.02 ) .


The women in the GnRHa group exhibited a greater increase of AT than the LNG-IUS users ( LNG-IUS : -0.7 9.5 % vs. GnRHa : 6.5 10.1 % , p = 0.02 ) .


Both hormonal treatments for endometriosis exhibited no association with a procoagulant profile .


Elderly patients with ST-segment elevation myocardial infarction ( STEMI ) have worse outcomes and a greater risk of intracranial bleeding than nonelderly patients .


Baseline characteristics , clinical outcomes , and the relationship of the tenecteplase ( TNK ) dose reduction to the efficacy , safety , and electrocardiographic indicators of reperfusion efficacy were evaluated in STEMI patients 75 years .


The STREAM trial evaluated early presenting STEMI patients who could not undergo primary percutaneous coronary intervention within 1 hour of first medical contact .


Because of excess intracranial hemorrhage ( ICH ) in patients 75 years , the dose of TNK was reduced by 50 % .


Before dose amendment , there were 3 ( 7.1 % ) of 42 elderly patients with ICH ; 2 of these were fatal , whereas no ICH occurred in the 93 elderly patients who received half-dose TNK postamendment .


The median extent of ST-segment elevation resolution ( 50 % ) and proportion of patients with 2 mm in the electrocardiogram lead with greatest ST-segment elevation was comparable in elderly patients preamendment and postamendment ( 63.2 % vs 56.0 % and 43.6 % vs 40.0 % , respectively ) .


Patients requiring rescue coronary intervention after TNK was also similar ( 42.9 % vs 44.1 % ) .


The primary composite end point ( 30-day all-cause death , cardiogenic shock , congestive heart failure , and reinfarction ) was 31.0 % before versus 24.7 % postamendment .


Our data , from a modest-sized population of elderly STEMI patients , indicate that half-dose TNK reduces the likelihood of ICH without compromising reperfusion efficacy .


These observations are hypothesis generating and warrant further confirmation in randomized clinical trials in the elderly .


The aim of this study was to compare the efficacy , safety , antiplaque and antigingivitis properties of a herbal mouthwash with chlorhexidine mouthwash .


A double-blinded randomized clinical trial was conducted among 72 undergraduate students with age group 18-24 years .


They were randomly divided into three mouthwash group with 24 participants in each group .


Group A ( herbal ) , Group B ( chlorhexidine ) and Group C ( normal saline ) .


The Turesky et al. 1970 plaque index and Loe and Silness 1963 gingival index was recorded .


Student 's t-test and one-way ANOVA were used to test the significance .


A statistically highly significant difference was obtained between mouthwash B and C ( p = 0.00 ) and a significant difference between mouthwash A and C ( p = 0.004 ) , showing that chlorhexidine was superior to herbal mouthwash and saline .


However , there was a nonsignificant difference between mouthwash A and B ( p = 0.435 ) showing that herbal and chlorhexidine mouthwash was equally effective in reducing plaque and gingivitis .


The efficacy of herbal mouthwash was equally effective in reducing plaque and gingivitis as compared to chlorhexidine mouthwash and may be considered as a good alternative .


The chlorhexidine mouthwash was reported with many side effects which limits its acceptability and long-term use , whereas the presently tested herbal mouthwash had no side effects apart from mild burning sensation .


Exposure to trauma reminders has been considered imperative in psychotherapy for posttraumatic stress disorder ( PTSD ) .


The authors tested interpersonal psychotherapy ( IPT ) , which has demonstrated antidepressant efficacy and shown promise in pilot PTSD research as a non-exposure-based non-cognitive-behavioral PTSD treatment .


The authors conducted a randomized 14-week trial comparing IPT , prolonged exposure ( an exposure-based exemplar ) , and relaxation therapy ( an active control psychotherapy ) in 110 unmedicated patients who had chronic PTSD and a score > 50 on the Clinician-Administered PTSD Scale ( CAPS ) .


Randomization stratified for comorbid major depression .


The authors hypothesized that IPT would be no more than minimally inferior ( a difference < 12.5 points in CAPS score ) to prolonged exposure .


All therapies had large within-group effect sizes ( d values , 1.32-1 .88 ) .


Rates of response , defined as an improvement of > 30 % in CAPS score , were 63 % for IPT , 47 % for prolonged exposure , and 38 % for relaxation therapy ( not significantly different between groups ) .


CAPS outcomes for IPT and prolonged exposure differed by 5.5 points ( not significant ) , and the null hypothesis of more than minimal IPT inferiority was rejected ( p = 0.035 ) .


Patients with comorbid major depression were nine times more likely than nondepressed patients to drop out of prolonged exposure therapy .


IPT and prolonged exposure improved quality of life and social functioning more than relaxation therapy .


This study demonstrated noninferiority of individual IPT for PTSD compared with the gold-standard treatment .


IPT had ( nonsignificantly ) lower attrition and higher response rates than prolonged exposure .


Contrary to widespread clinical belief , PTSD treatment may not require cognitive-behavioral exposure to trauma reminders .


Moreover , patients with comorbid major depression may fare better with IPT than with prolonged exposure .


To investigate the impact of cyclooxygenase-2 ( COX-2 ) inhibitor with - adrenoceptor blocker ( - blocker ) for men with benign prostatic hyperplasia ( BPH ) and lower urinary tract symptoms ( LUTS ) for detecting prostate cancer in men with elevated prostate specific antigen ( PSA ) .


Male patients with clinical BPH , elevated serum PSA ( > 4ng/ml ) , and significant LUTS ( International Prostate Symptom Score [ IPSS ] 8 ) were randomly assigned to receive doxazosin 4mg daily plus celecoxib 200mg daily ( study group ) or doxazosin 4mg daily alone ( control group ) for 3months .


Patients were investigated for the changes in IPSS , maximum flow rate ( Qmax ) , voided volume , postvoid residual ( PVR ) volume and serum PSA from baseline to 3months after treatment .


After the 3-month therapy , prostate biopsy was performed in the patients whose PSA were still higher than 4ng/ml .


A total of 82 patients completed the study .


The improvement in IPSS-voiding was significantly greater in the study group than control group ( p = 0.034 ) .


In the study group , patients with prostatic hyperplasia or inflammation on the prostate biopsy had a significantly better result than in patients with prostatic adenocarcinoma , typically in the changes of Qmax and voided volume ( p = 0.012 and p = 0.005 , respectively ) .


The PSA level in the study group showed significant improvement after treatment ( p < 0.01 ) .


However , prostate cancer detection rate failed to show any significant difference between the patients whose PSA levels decreased or not ( 6/21 = 29 % vs. 5/24 = 20 % , respectively , p = 0.447 ) .


Treatment with COX-2 inhibitor and - blocker for 3months could not improve prostatic cancer detection rate .


But it could increase therapeutic effectiveness of LUTS in men with BPH and elevated PSA levels .


The changes in Qmax and voided volume after combination treatment were significantly greater in patients with prostatic hyperplasia or inflammation than adenocarcinoma .


A variety of analgesic agents are available , and which one can be used in dogs and cats is a highly controversial issue , existing however a fear in the use of opiates due to possible adverse effects that these drugs can cause .


The aim of this study was to compare the analgesic effect provided by the administration of tramadol or pethidine on early postoperative pain of cats undergoing ovariohysterectomy in a double-blind prospective study .


Fourty-two animals were randomly assigned into three groups .


Pet received pethidine ( 6 mg/kg ) , Tra 2 received tramadol ( 2 mg/kg ) and Tra 4 received tramadol ( 4 mg/kg ) ; all intramuscularly and associated with acepromazine ( 0.1 mg/kg ) .


The efficacy of each analgesic regimen was evaluated prior to surgery ( baseline - TBL ) , during surgery and 1 , 3 and 6 hours after extubation with subjective pain scale , physiologic parameters , serum concentrations of glucose , cortisol and IL-6 .


Changes in cardiovascular system were not clinically relevant .


There were no significant differences in pain scores ( P > 0.05 ) during the study , although the number of rescue analgesia was significantly higher ( P < 0.05 ) at Pet group ( 5/14 ) than Tra 4 group ( 0/14 ) , whereas in Tra 2 , two animals ( 2/14 ) required additional analgesia .


The serum cortisol values of Pet group were significantly higher at T1h T3h ( P < 0.05 ) and T6h ( P < 0.01 ) when compared to baseline ( induction ) , also it was noticed a significant difference among the groups at T6h ( Pet values were higher than Tra 2 and Tra 4 ; P < 0.05 ) .


Tramadol provided adequate analgesia and it was more effective than pethidine to at least six hours for the studied animals .


At the higher dose ( 4 mg/kg ) tramadol is probably more effective , since rescue analgesia was not necessary .


No significant changes were observed physiological parameter that could contraindicate the use of these opioid in described doses , for the feline species .


CD133 + cells confer angiogenic potential and may be beneficial for the treatment of critical limb ischemia ( CLI ) .


However , patient selection , blinding methods and end points for clinical trials are challenging .


We hypothesized that bilateral intramuscular administration of cytokine-mobilized CD133 + cells in ambulatory patients with refractory CLI would be feasible and safe .


In this double-blind , randomized sham-controlled trial , subjects received subcutaneous injections of granulocyte colony-stimulating factor ( 10 g/kg per day ) for 5 days , followed by leukapheresis , and intramuscular administration of 50-400 million sorted CD133 + cells delivered into both legs .


Control subjects received normal saline injections , sham leukapheresis and intramuscular injection of placebo buffered solution .


Subjects were followed for 1 year .


An aliquot of CD133 + cells was collected from each subject to test for genes associated with cell senescence .


Seventy subjects were screened , of whom 10 were eligible .


Subject enrollment was suspended because of a high rate of mobilization failure in subjects randomly assigned to treatment .


Of 10 subjects enrolled ( 7 randomly assigned to treatment , 3 randomly assigned to control ) , there were no differences in serious adverse events at 12 months , and blinding was preserved .


There were non-significant trends toward improved amputation-free survival , 6-minute walk distance , walking impairment questionnaire and quality of life in subjects randomly assigned to treatment .


Successful CD133 + mobilizers expressed fewer senescence-associated genes compared with poor mobilizers .


Bilateral administration of autologous CD133 + cells in ambulatory CLI subjects was safe , and blinding was preserved .


However , poor mobilization efficiency combined with high CD133 + senescence suggests futility in this approach .


Severe borderline personality disorder is associated with a very high psychosocial and economic burden .


Current treatment guidelines suggest that several manualized treatments , including day hospital Mentalization-Based Treatment ( MBT-DH ) , are effective in these patients .


However , only two randomized controlled trials have compared manualized MBT-DH with treatment as usual .


Given the relative paucity of data supporting the efficacy and cost-effectiveness of MBT-DH , the possible influence of researcher allegiance in one of the trials , and potential problems with the generalization of findings to mental health systems in other countries , this multi-site randomized trial aims to investigate the efficacy and cost-effectiveness of manualized MBT-DH compared to manualized specialist treatment as usual in The Netherlands .


The trial is being conducted at two sites in The Netherlands .


Patients with a DSM-IV-TR diagnosis of borderline personality disorder and a score of20 on the Borderline Personality Disorder Severity Index were randomly allocated to MBT-DH or treatment as usual .


The MBT-DH program consists of a maximum of 18months ' intensive treatment , followed by a maximum of 18months of maintenance therapy .


Specialist treatment as usual is provided by the City Crisis Service in Amsterdam , a service that specializes in treating patients with personality disorders , offering manualized , non-MBT interventions including family interventions , Linehan training , social skills training , and pharmacotherapy , without a maximum time limit .


Patients are assessed at baseline and subsequently every 6months up to 36months after the start of treatment .


The primary outcome measure is the frequency and severity of manifestations of borderline personality disorder as assessed by the Borderline Personality Disorder Severity Index .


Secondary outcome measures include parasuicidal behaviour , symptomatic distress , social and interpersonal functioning , personality functioning , attachment , capacity for mentalizing and quality of life .


Cost-effectiveness is assessed in terms of the cost per quality-adjusted life year .


Outcomes will be analyzed using multilevel analyses based on intention-to-treat principles .


Severe borderline personality disorder is a serious psychological disorder that is associated with high burden .


This multi-site randomized trial will provide further data concerning the efficacy and cost-effectiveness of MBT-DH for these patients .


NTR2175 .


The objective of the study was to determine whether vitamin D ( vitD ) supplementation during pregnancy affects obstetric and neonatal outcomes .