Differences in engagement across the demographic/weight status subgroups were examined using chi-square analysis .


Six engagement patterns emerged : `` super-users '' ( 13.02 % , 132/1014 ) , `` medium-users '' ( 14.00 % , 142/1014 ) , `` consistent weight-tracker users '' ( 14.99 % , 152/1014 ) ; `` almost consistent weight-tracker users '' ( 21.99 % , 223/1014 ) , `` inconsistent weight-tracker users '' ( 15.98 % , 162/1014 ) , and `` non-users '' ( 20.02 % , 203/1014 ) .


Four demographic/weight status subgroups emerged : three minority and one white .


There were different engagement patterns by demographic/weight status subgroups .


Super-users were more likely to be in the white subgroup , while non-users were more likely to be in the minority subgroups .


However , around a third of women in minority subgroups were consistently or almost consistently engaging with the weight-tracker ( black , young women , 32.2 % , 67/208 ; black , heavier women , 37.9 % , 50/132 ; Hispanic women , 27.4 % , 32/117 ) .


While white and higher income women had higher engagement in general , depending on the measure , there was still considerable engagement by the minority and low-income women .


Clinicaltrials.gov : NCT01331564 ; http://clinicaltrials.gov/ct2/show/NCT01331564 ( Archived by WebCite at http://www.webcitation.org/6Rw4yKxI5 ) .


To test whether supervised pelvic floor exercises antenatally will reduce the incidence of postpartum stress incontinence in at-risk primigravidae with bladder neck mobility , ultrasonically proven .


Single blind , randomised controlled trial .


Antenatal clinic in a UK NHS Trust Hospital .


Two hundred and sixty-eight primigravidae attending an antenatal clinic at approximately 20 weeks of gestation with bladder neck mobility , on standardised valsalva , of 5 mm or more linear movement .


The median age was 28 , ranging from 16 to 47 years .


Patients randomised to supervised pelvic floor exercises ( n = 139 ) attended a physiotherapist at monthly intervals from 20 weeks until delivery .


The exercises comprised three repetitions of eight contractions each held for six seconds , with two minutes rest between repetitions .


These were repeated twice daily .


At 34 weeks of gestation the number of contractions per repetition was increased to 12 .


Both the untreated control group and the study group received verbal advice on pelvic floor exercises from their midwives antenatally .


Subjective reporting of stress incontinence at three months postpartum .


Pelvic floor strength , using perineometry , and bladder neck mobility measured by perineal ultrasound .


Of the 268 women enrolled , information on the main outcome variable was available for 110 in the control group and 120 in the study group .


Fewer women in the supervised pelvic floor exercise group reported postpartum stress incontinence , 19.2 % compared with 32.7 % in the control group ( RR 0.59 [ 0.37-0 .92 ] ) .


There was no change in bladder neck mobility and no difference in pelvic floor strength between groups after exercise , although all those developing postpartum stress incontinence had significantly poorer perineometry scores than those who were continent .


The findings suggest that antenatal supervised pelvic floor exercises are effective in reducing the risk of postpartum stress incontinence in primigravidae with bladder neck mobility .


The aim of the present study was to evaluate the procedural feasibility , the safety and the 1-year outcome following left atrial appendage ( LAA ) closure using the Amplatzer cardiac plug ( ACP ) in Belgium .


Data were prospectively collected among 90 consecutive patients , undergoing LAA closure with an ACP in 7 Belgian centres between June 2009 and September 2012 .


The patients ( 56 males , 74 + / - 8 years ) were at high risk for stroke ( CHA2DS2-VASc = 4.4 + / - 1.8 ) and bleeding ( HAS-BLED = 3.3 + / - 1.3 ) .


Technical success was obtained in all but one patient and procedural success was 95 % .


Procedural major adverse events ( MAE ) were 3 tamponades resulting in death in one case .


Minor complications were 3 insignificant pericardial effusions , 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm .


At 1-y follow-up , there were 4 deaths , 2 minor strokes , 1 tamponade and 1 myocardial infarction .


Overall survival was 94 % and freedom from MAE was 88 % .


In our population , the expected annual stroke risk according to the CHA2DS2-VASc score was 5.08 % , while the observed stroke rate was 2.14 % / year .


The Belgian registry shows that LAA closure using the ACP device is feasible and safe .


At 1-y follow-up , the observed stroke rate was 2.14 % / year , less than predicted by the CHA2DS2-VASc score .


Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke .


Self-monitoring by mobile phone applications offers new opportunities to engage patients in self-management .


Self-monitoring has not been examined thoroughly as a self-directed intervention strategy for self-management of multiple behaviors and states by people living with HIV ( PLH ) .


PLH ( n = 50 ) , primarily African American and Latino , were recruited from 2 AIDS services organizations and randomly assigned to daily smartphone ( n = 34 ) or biweekly Web-survey only ( n = 16 ) self-monitoring for 6 weeks .


Smartphone self-monitoring included responding to brief surveys on medication adherence , mental health , substance use , and sexual risk behaviors , and brief text diaries on stressful events .


Qualitative analyses examine biweekly open-ended user-experience interviews regarding perceived benefits and barriers of self-monitoring , and to elaborate a theoretical model for potential efficacy of self-monitoring to support self-management for multiple domains .


Self-monitoring functions include reflection for self-awareness , cues to action ( reminders ) , reinforcements from self-tracking , and their potential effects on risk perceptions , motivations , skills , and behavioral activation states .


Participants also reported therapeutic benefits related to self-expression for catharsis , nonjudgmental disclosure , and in-the-moment support .


About one-third of participants reported that surveys were too long , frequent , or tedious .


Some smartphone group participants suggested that daily self-monitoring was more beneficial than biweekly due to frequency and in-the-moment availability .


About twice as many daily self-monitoring group participants reported increased awareness and behavior change support from self-monitoring compared with biweekly Web-survey only participants .


Self-monitoring is a potentially efficacious disruptive innovation for supporting self-management by PLH and for complementing other interventions , but more research is needed to confirm efficacy , adoption , and sustainability .


The purpose of this study was to compare the clinical efficacy of an anorganic bovine bone graft particulate to that of a calcium phosphosilicate putty alloplast for socket preservation .


Thirty teeth were extracted from 24 patients .


The sockets were debrided and received anorganic bovine bone mineral ( BOV , n = 12 ) , calcium phosphosilicate putty ( PUT , n = 12 ) , or no graft ( CTRL , n = 6 ) .


The sockets were assessed clinically and radiographically 5 months later .


Eight sockets in the BOV group and nine in the PUT group received implants 5 to 6 months postgrafting .


The maximum implant insertion torque ( MIT ) was measured as an index of primary implant stability .


The data were analyzed with the Mann-Whitney test .


Both test groups had statistically significantly less reduction in mean ridge width ( BOV : 1.390.57 mm ; PUT : 1.260.41 mm ) in comparison to the control group ( 2.530.59 mm ) .


No statistically significant difference was identified between the test groups .


MIT for PUT was 35 N/cm ( MIT grade 4 ) for seven of the nine implants .


MIT values in the BOV group ranged from grade 1 ( 10 to 19 N/cm ) to grade 4 , which was statistically significantly lower than for the PUT group .


The overall implant success rate was 94.1 % ( 16 of 17 implants were successful ) .


No implants were lost in the PUT group ; one implant failed in the BOV group .


Both tested bone substitutes can be recommended for preservation of alveolar ridge width following extraction .


PUT might be more suitable for achieving primary stability for implants placed at 5 to 6 months postextraction .


There is convincing evidence that unsaturated fatty acids exert favourable effects on plasma cholesterol levels .


However , it is not clear which type of oil has the most pronounced effect , especially not in paediatric patients .


The aim was to compare two low-fat diet regimes enriched with either monounsaturated fatty acids by rapeseed oil ( RO ) or polyunsaturated fatty acids by sunflower oil ( SO ) in children affected with familial hypercholesterolaemia ( FH ) .


Twenty-one children aged 6-18 years affected with FH were enrolled in this randomized and double-blind pilot trial .


The subjects and their families were trained to adhere to a low-fat/low-cholesterol diet .


All visible fats were to be replaced by either RO or SO ( 14-27g / day ) for 13 weeks .


Dietary adherence was controlled by repeated 4-day dietary records ; plasma lipids , lipoproteins and risk markers were assessed at baseline and post-intervention .


Out of 21 subjects , 16 could be followed-up after 6 months .


Both fat-modified diets resulted in significant reduction in total cholesterol concentrations of 9.4 % ( RO P < 0.005 vs SO P < 0.05 ) and low-density lipoprotein ( LDL ) cholesterol concentrations of 12.7 % ( P < 0.005 ) for RO and 11.3 % ( P < 0.05 ) for SO .


The reduction of the LDL/high-density lipoprotein ( HDL ) cholesterol ratio ( RO 9 % vs SO 3.5 % ) and high-sensitivity C-reactive protein ( RO 16.8 % vs SO 1.7 % ) were not statistically significant , respectively .


In most participating families , a change in eating habits could be observed .


A fat-modified diet enriched with RO seems to have very similar effects on cholesterol levels as with SO .


However , our study suggests that RO has possibly more favourable effects concerning cardiovascular risk profile .


Both diets appear to be feasible and were well accepted among our subjects .


Although these results are promising , larger trials will be required to validate our findings .


The present analysis describes the longitudinal change in buprenorphine treatment outcome .


It also examines several participant characteristics to predict response to buprenorphine .


Participants ( n = 501 , age > 15 years ) received buprenorphine/naloxone treatment for 4 weeks , and then were randomly assigned to undergo dose tapering over either 7 days or 28 days .


An empirical model was developed to describe the longitudinal changes in treatment outcome .


Several patient characteristics were also examined as possible factors influencing treatment outcome .


We have developed a model that captures the general behavior of the longitudinal change in the probability of having an opioid-negative urine sample following buprenorphine treatment .


The model captures both the initial increase ( i.e. , initial response ) and the subsequent decrease ( i.e. , relapse to opioid ) in the likelihood of providing an opioid-negative urine sample .


Characteristics associated with successful buprenorphine treatment outcome include : having a negative urine test for drugs , having alcohol problems [ assessed using alcohol domain of addiction severity index ( ASI-alcohol ) ] at screening , being older , and receiving low cumulative buprenorphine dose .


However , ASI-alcohol values were generally low which make the application of the proposed alcohol effect for patients with more severe alcohol problems questionable .


A novel approach for analyzing buprenorphine treatment outcome is presented in this manuscript .


This approach describes the longitudinal change in the probability of providing an opioid-free urine sample instead of considering opioid use outcome at a single time point .


Additionally , this model successfully describes relapse to opioid .


Finally , several patient characteristics are identified as predictors of treatment outcome .


We compared the quantitative clinical performances of the streamlined liner of the pharynx airway ( SLIPA ) and the ProSeal laryngeal mask airway ( LMA ProSeal ) regarding intensity of gastric distension in patients undergoing laparoscopic cholecystectomy .


A total of 124 anesthetized , paralyzed patients ( ASA 1 to 2 ; aged , 18 to 80 y ) were randomly allocated for airway management with the SLIPA or LMA ProSeal .


After induction of general anesthesia using total intravenous anesthesia and rocuronium , the intensity of gastric distension was accessed twice by 2 raters , respectively .


We also compared the fiberoptic bronchoscopic view of the glottis , the severity of blood stain , and postoperative sore throat .


There were no statistically significant differences between groups for each gastric size .


The change of gastric size within the SLIPA group was not statistically significant for both raters .


Change within the LMA ProSeal group was significant in rater 2 ( P = 0.045 ) and marginally significant for rater 1 ( P = 0.056 ) .


Anatomic fit , complications during emergence , and the severity of blood stain and postoperative sore throat were similar in both groups .


SLIPA is as efficacious as LMA ProSeal for use in patients without severe complications who are undergoing laparoscopic cholecystectomy .


To investigate the effectiveness of brief intervention ( BI ) conducted in the workplace for heavy drinkers .


A randomized controlled trial was conducted at six companies in Japan .


Participants were heavy drinkers who met the inclusion criteria and were randomized into three groups : the BI group , BI with diary group and a control group .


Outcomes ( total drinks , binge drinking episodes and alcohol-free days ) were evaluated at 3 and 12 months .


The 304 participants recruited were allocated to the three groups and 277 participated in all follow-up evaluations .


Dropout rates in the respective groups were 7.0 , 14.9 and 5.5 % .


Some improvements were observed in all the groups .


In particular , alcohol-free days in the BI group were significantly increased by 93.0 % at 12 months .


Total drinks at 12 months were reduced by 41 g per week in the BI group compared with the control group , although the intergroup difference was not significant .


BI in the workplace is effective for increasing the number of alcohol-free days .


However , the effectiveness on decreasing alcohol consumption was unclear , which could be explained by alcohol screening itself causing a reduction in drinking .


Several observational studies were conducted with vildagliptin in patients with type 2 diabetes mellitus ( T2DM ) fasting during Ramadan , showing significantly lower incidences of hypoglycemia with vildagliptin versus sulfonylureas , including gliclazide .


It was of interest to complement the existing real-life evidence with data from a randomized , double-blind , clinical trial .


NCT01758380 .


This multiregional , double-blind study randomized 557 patients with T2DM ( mean glycated hemoglobin [ HbA1c ] , 6.9 % ) , previously treated with metformin and any sulfonylurea to receive either vildagliptin ( 50 mg twice daily ) or gliclazide plus metformin .


The study included four office visits ( three pre-Ramadan ) and multiple telephone contacts , as well as Ramadan-focused advice .


Hypoglycemic events were assessed during Ramadan ; HbA ( 1c ) and weight were analyzed before and after Ramadan .


The proportion of patients reporting confirmed ( < 3.9 mmol/L and/or severe ) hypoglycemic events during Ramadan was 3.0 % with vildagliptin and 7.0 % with gliclazide ( P = 0.039 ; one-sided test ) , and this was 6.0 % and 8.7 % , respectively , for any hypoglycemic events ( P = 0.173 ) .


The adjusted mean change pre - to post-Ramadan in HbA ( 1c ) was 0.05 % 0.04 % with vildagliptin and -0.03 % 0.04 % with gliclazide , from baselines of 6.84 % and 6.79 % , respectively ( P = 0.165 ) .


In both groups , the adjusted mean decrease in weight was -1.10.2 kg ( P = 0.987 ) .


Overall safety was similar between the treatments .


In line with the results from previous observational studies , vildagliptin was shown in this interventional study to be an effective , safe , and well-tolerated treatment in patients with T2DM fasting during Ramadan , with a consistently low incidence of hypoglycemia across studies , accompanied by good glycemic and weight control .


In contrast , gliclazide showed a lower incidence of hypoglycemia in the present interventional than the previous observational studies .


This is suggested to be linked to the specific circumstances of this study , including frequent patient-physician contacts , Ramadan-focused advice , a recent switch in treatment , and very well-controlled patients , which is different from what is often seen in real life .


AMG 181 pharmacokinetics/pharmacodynamics ( PK/PD ) , safety , tolerability and effects after single subcutaneous ( s.c. ) or intravenous ( i.v. ) administration were evaluated in a randomized , double-blind , placebo-controlled study .


Healthy male subjects ( n = 68 ) received a single dose of AMG 181 or placebo at 0.7 , 2.1 , 7 , 21 , 70mg s.c. ( or i.v. ) , 210mg s.c. ( or i.v. ) , 420mg i.v. or placebo .


Four ulcerative colitis ( UC ) subjects ( n = 4 , male : female 2:2 ) received 210mg AMG 181 or placebo s.c. ( 3:1 ) .


AMG 181 concentration , anti-AMG 181-antibody ( ADA ) , 4 7 receptor occupancy ( RO ) , target cell counts , serum C-reactive protein , fecal biomarkers and Mayo score were measured .


Subjects were followed 3-9 months after dose .


Following s.c. dosing , AMG 181 was absorbed with a median tmax ranging between 2-10 days and a bioavailability between 82 % and 99 % .


Cmax and AUC increased dose-proportionally and approximately dose-proportionally , respectively , within the 70-210mg s.c. and 70-420mg i.v. ranges .


The linear - phase t1/2 was 31 ( range 20-48 ) days .


Target-mediated disposition occurred at serum AMG 181 concentrations of less than 1gml ( -1 ) .


The PD effect on 4 7 RO showed an EC50 of 0.01 gml ( -1 ) .


Lymphocytes , eosinophils , CD4 + T cells and subset counts were unchanged .


AMG 181-treated UC subjects were in remission with mucosal healing at weeks 6 , 12 and/or 28 .


The placebo-treated UC subject experienced colitis flare at week 6 .


No ADA or AMG 181 treatment-related serious adverse events were observed .


AMG 181 has PK/PD , safety , and effect profiles suitable for further testing in subjects with inflammatory bowel diseases .


Behavioral migraine approaches are effective in reducing headache attacks .


Availability of treatment might be increased by using migraine patients as trainers .


Therefore , Mrelle and colleagues developed and evaluated a home-based behavioral management training ( BMT ) by lay trainers ( 1 ) .


The maintenance of effects at long-term follow-up is studied in the present study .


Measurements were taken pre-BMT ( T0 ) , post-BMT ( T1 ) , at six-month follow-up ( T2 ) , and at long-term follow-up , i.e. two to four years after BMT ( T3 ) .


Data of 127 participants were analyzed with longitudinal multi-level analyses .


Short-term improvements in attack frequency and self-efficacy post-BMT were maintained at long-term follow-up ( DT0T3 = -.34 and DT0T3 = .69 , respectively ) .


The level of internal control that increased during BMT decreased from post-BMT to long-term follow-up ( DT0T3 = .18 ) .


Quality of life and migraine-related disability improved gradually over time ( DT0T3 = .45 and DT0T3 = -.26 , respectively ) .


Although the results should be interpreted with caution because of the lack of a follow-up control group and the inability to gather information about additional treatments patients may have received during the follow-up period , the findings suggest that lay BMT for migraine may be beneficial over the long term .


If so , this could make migraine treatments more widely available .


: Although numerous animal studies suggest that probiotic therapy has beneficial effects in various liver diseases , the evidence for beneficial effects in human liver disease is controversial .


This study was carried out to investigate the efficacy of probiotic therapy in alleviating small intestinal bacterial overgrowth ( SIBO ) and permeability in chronic liver disease .


Fifty-three patients with chronic liver disease were randomized to either probiotic therapy or placebo .


Six bacterial species were used : Bifidobacterium bifidum , Bifidobacterium lactis , Bifidobacterium longum , Lactobacillus acidophilus , Lactobacillus rhamnosus , and Streptococcus thermophilus .


After 4 weeks , changes in the composition of fecal bacteria , SIBO , intestinal permeability , and clinical symptoms were examined .


Three of the six probiotic species , B. lactis , L. rhamnosus , and L. acidophilus , increased in the feces of the probiotic therapy group ( P < 0.001 ) , whereas there was no change in fecal microbiota in the placebo group .


SIBO disappeared in many individuals of the probiotic therapy group , but none in the placebo ( 24 vs. 0 % , P < 0.05 ) .


General gastrointestinal symptoms also improved more in the probiotic group and improvement in intestinal permeability was slightly but not significantly more frequent in the probiotic arm than the placebo arm ( 50 vs. 31.3 % , P = 0.248 ) .


Numbers of lactobacilli in stool were correlated negatively with intestinal permeability ( P for trend < 0.05 ) .


Liver chemistry did not improve significantly in either group .


We conclude that short-term probiotic administration in chronic liver disease is effective in alleviating SIBO and clinical symptoms , but ineffective in improving intestinal permeability and liver function .


Hydration to prevent contrast-induced acute kidney injury ( CI-AKI ) induces a diagnostic delay when performing computed tomography-pulmonary angiography ( CTPA ) in patients suspected of having acute pulmonary embolism .


To analyze whether withholding hydration is non-inferior to sodium bicarbonate hydration before CTPA in patients with chronic kidney disease ( CKD ) .


We performed an open-label multicenter randomized trial between 2009 and 2013 .


One hundred thirty-nine CKD patients were randomized , of whom 138 were included in the intention-to-treat population : 67 were randomized to withholding hydration and 71 were randomized to 1-h 250mL 1.4 % sodium bicarbonate hydration before CTPA .


Primary outcome was the increase in serum creatinine 48-96h after CTPA .


Secondary outcomes were the incidence of CI-AKI ( creatinine increase > 25 % / > 0.5 mgdL ( -1 ) ) , recovery of renal function , and the need for dialysis within 2months after CTPA .


Withholding hydration was considered non-inferior if the mean relative creatinine increase was 15 % compared with sodium bicarbonate .


Mean relative creatinine increase was -0.14 % ( interquartile range -15.1 % to 12.0 % ) for withholding hydration and -0.32 % ( interquartile range -9.7 % to 10.1 % ) for sodium bicarbonate ( mean difference 0.19 % , 95 % confidence interval -5.88 % to 6.25 % , P-value non-inferiority < 0.001 ) .


CI-AKI occurred in 11 patients ( 8.1 % ) : 6 ( 9.2 % ) were randomized to withholding hydration and 5 ( 7.1 % ) to sodium bicarbonate ( relative risk 1.29 , 95 % confidence interval 0.41-4 .03 ) .


Renal function recovered in 80.0 % of CI-AKI patients within each group ( relative risk 1.00 , 95 % confidence interval 0.54-1 .86 ) .


None of the CI-AKI patients developed a need for dialysis .


Our results suggest that preventive hydration could be safely withheld in CKD patients undergoing CTPA for suspected acute pulmonary embolism .


This will facilitate management of these patients and prevents delay in diagnosis as well as unnecessary start of anticoagulant treatment while receiving volume expansion .


To evaluate the impact of sending an email to responsible parties of completed trials that do not comply with the Food and Drug Administration Amendments Act 801 legislation , to remind them of the legal requirement to post results .


Cohort embedded pragmatic randomized controlled trial .


Trials registered on ClinicalTrials.gov .


190 out of 379 trials randomly selected by computer generated randomization list to receive the intervention ( personalized emails structured as a survey and sent by one of us to responsible parties of the trials , indirectly reminding them of the legal requirement and potential penalties for non-compliance ) .


The primary outcome was the proportion of results posted on ClinicalTrials.gov at three months .


The secondary outcome was the proportion posted at six months .


In a second step , two assessors blinded to the intervention group collected the date of the first results being received on ClinicalTrials.gov .


A post hoc sensitivity analysis excluding trials wrongly included was performed .


Among 379 trials included , 190 were randomized to receive the email intervention .


The rate of posting of results did not differ at three months between trials with or without the intervention : 36/190 ( 19 % ) v 24/189 ( 13 % ) , respectively ( relative risk 1.5 , 95 % confidence interval 0.9 to 2.4 , P = 0.096 ) but did at six months : 46/190 ( 24 % ) v 27/189 ( 14 % ) , 1.7 , 1.1 to 2.6 , P = 0.014 .


In the sensitivity analysis , which excluded 48/379 trials ( 13 % ) , 26/190 ( 14 % ) and 22/189 ( 12 % ) , respectively , results were significant at three months ( relative risk 5.1 , 1.1 to 22.9 , P = 0.02 ) and at six months ( 4.1 , 1.3 to 10.6 , P = 0.001 ) .


Sending email reminders about the FDA 's legal requirement to post results at ClinicalTrials.gov improved significantly the posting rate at six months but not at three months.Trial registration ClinicalTrials.gov NCT01658254 .


Restless leg syndrome ( RLS ) is one of the prevalent complaints of patients with end stage renal diseases suffering chronic hemodialysis .


Although there are some known pharmacological managements for this syndrome , the adverse effect of drugs causes a limitation for using them .


In this randomized clinical trial we aimed to find a nonpharmacological way to improve signs of restless leg syndrome and patients ' quality of life .


Twenty-six patients were included in the study and divided into 2 groups of control and exercise .


The exercise group used aerobic exercise during their hemodialysis for 16 weeks .


The quality of life and severity of restless leg syndrome were assessed at the first week of study and final week .


Data were analyzed using SPSS software .


The difference of means of RLS signs at the first week of study and final week was -5.5 4.96 in exercise group and -0.53 2.3 in control group .


There was not any statistical difference between control group and exercise group in quality of life at the first week of study and final week .


We suggest using aerobic exercise for improving signs of restless leg syndrome , but no evidence was found for its efficacy on patient 's quality of life .


Randomized controlled trials in developed countries have reported benefits of Lactobacillus GG ( LGG ) in the treatment of acute watery diarrhoea , but there is paucity of such data from India .


The study was aimed to evaluate the efficacy and safety of Lactobacillus GG in the treatment of acute diarrhoea in children from a semi-urban city in north India .


In this open labelled , randomized controlled trial 2000 children with acute watery diarrhoea , aged between 6 months to 5 years visiting outpatient department and emergency room of a teaching hospital in north India were enrolled .


The children were randomized into receiving either Lactobacillus GG in dose of 10 billion cfu/day for five days or no probiotic medication in addition to standard WHO management of diarrhoea .


Primary outcomes were duration of diarrhoea and time to change in consistency of stools .


Median ( inter quartile range ) duration of diarrhoea was significantly shorter in children in LGG group [ 60 ( 54-72 ) h vs. 78 ( 72-90 ) h ; P < 0.001 ] .


Also , there was faster improvement in stool consistency in children receiving Lactobacillus GG than control group [ 36 ( 30-36 ) h vs. 42 ( 36-48 ) h ; P < 0.001 ] .


There was significant reduction in average number of stools per day in LGG group ( P < 0.001 ) compared to the control group .


These benefits were seen irrespective of rotavirus positivity in stool tests .


Our results showed that the use of Lactobacillus GG in children with acute diarrhoea resulted in shorter duration and faster improvement in stool consistency as compared to the control group .


In persons 15 years and above in South Africa the prevalence of pre-diabetes and diabetes has been estimated at 9.1 % and 9.6 % , respectively , and the prevalence of systolic prehypertension and hypertension , 38.2 % and 24.6 % , respectively .


Elevated blood glucose and elevated blood pressure are prototype of preventable chronic cardiovascular disease risk factors.Lifestyle interventions have been shown to control high normal blood pressure and/or high normal blood glucose .


This study proposes to evaluate the efficacy of a community ( church ) - based lifestyle intervention programme to control high normal blood pressure and/or high normal blood glucose in church members in a randomized controlled trial in Gauteng , South Africa .


The objectives are to : ( 1 ) measure non-communicable diseases profile , including hypertension and diabetes , health behaviours , weight management and psychological distress of church members ; ( 2 ) measure the reduction of blood glucose and blood pressure levels after the intervention ; ( 3 ) prevent the development of impaired glucose tolerance ; ( 4 ) compare health behaviours , weight management and psychological distress , blood glucose and blood pressure levels between intervention and control groups , and within group during 6 , 12 , 24 and 36 months during and post intervention .


The study will use a group-randomized design , recruiting 300 church members from 12 churches .


Churches will be randomly assigned to experimental and control conditions .


Lifestyle interventions may prevent from the development of high blood pressure and/or diabetes .


The findings will impact public health and will enable the health ministry to formulate policy related to lifestyle interventions to control blood pressure and glucose .


PACTR201105000297151 .


The aim of the present study was to analyze the efficacy of Papacarie ( ) gel compared with the traditional method ( low-speed bur ) in reducing the counts of total bacteria , Lactobacillus , total Streptococcus and Streptococcus mutans group .


A randomized , controlled clinical trial with a split-mouth design was performed .


The sample comprised 40 deciduous teeth in 20 children ( 10 males and 10 females ) aged four to seven years .


The teeth were randomly allocated to two groups : G1 , or chemomechanical caries removal with Papacarie Duo ( ) , and G2 , or the removal of carious dentin tissue with a low-speed bur .


Infected dentin was collected prior to the procedure , and the remaining dentin was collected immediately following the removal of the carious tissue .


Initial and final counts of bacterial colonies were performed to determine whether there was a reduction in the number of colony-forming units ( CFUs ) of each microorganism studied .


ClinicalTrials.gov : NCT01811420 .


Reductions were found in the numbers of total bacteria , total Streptococcus and Streptococcus mutans group following either of the caries removal methods ( p < 0.05 ) .


A reduction was also noted in the number of Lactobacillus CFUs ; however , this difference did not achieve statistical significance ( p > 0.05 ) .


Papacarie ( ) is an excellent option for the minimally invasive removal of carious tissue , achieving significant reductions in total bacteria , total Streptococcus and S. mutans with the same effectiveness as the traditional caries removal method .


Studies in animals and in vitro and phase 2 studies in humans suggest that statins may be beneficial in the treatment of the acute respiratory distress syndrome ( ARDS ) .


This study tested the hypothesis that treatment with simvastatin would improve clinical outcomes in patients with ARDS .


In this multicenter , double-blind clinical trial , we randomly assigned ( in a 1:1 ratio ) patients with an onset of ARDS within the previous 48 hours to receive enteral simvastatin at a dose of 80 mg or placebo once daily for a maximum of 28 days .


The primary outcome was the number of ventilator-free days to day 28 .


Secondary outcomes included the number of days free of nonpulmonary organ failure to day 28 , mortality at 28 days , and safety .


The study recruited 540 patients , with 259 patients assigned to simvastatin and 281 to placebo .


The groups were well matched with respect to demographic and baseline physiological variables .


There was no significant difference between the study groups in the mean ( SD ) number of ventilator-free days ( 12.69.9 with simvastatin and 11.510.4 with placebo , P = 0.21 ) or days free of nonpulmonary organ failure ( 19.411.1 and 17.811.7 , respectively ; P = 0.11 ) or in mortality at 28 days ( 22.0 % and 26.8 % , respectively ; P = 0.23 ) .


There was no significant difference between the two groups in the incidence of serious adverse events related to the study drug .


Simvastatin therapy , although safe and associated with minimal adverse effects , did not improve clinical outcomes in patients with ARDS .


( Funded by the U.K. National Institute for Health Research Efficacy and Mechanism Evaluation Programme and others ; HARP-2 Current Controlled Trials number , ISRCTN88244364 . )


Despite improvements in endovascular therapy for lower extremity arterial disease , open surgical revascularization is still required when the disease is extensive .


Although autogenous vein is the conduit of choice for open femoropopliteal bypass , prosthetic grafts can be an acceptable alternative when adequate vein is not available .


The FUSION BIOLINE heparin-coated vascular graft ( Maquet Endovascular , Wayne , NJ ) was developed to improve the patency rate associated with standard prosthetic grafts .


The current study , the FINEST Trial ( Comparison of Safety and Primary Patency Between the FUSION BIOLINE Heparin-Coated Vascular Graft and EXXCEL Soft ePTFE ) , was designed to assess the clinical outcome of heparin-coated and standard vascular grafts in a prospective , randomized , controlled , multicenter trial .


During a 25-month period ending in June 2012 , 209 eligible patients scheduled to undergo elective prosthetic femoral to above-knee or below-knee popliteal bypass were randomized to receive a standard expanded polytetrafluoroethylene ( ePTFE ) graft or the heparin-coated FUSION BIOLINE vascular graft .


Among 203 patients in the efficacy analysis , claudication was the presenting symptom in 147 ( 72.4 % ) , and the site of the distal anastomosis was at the above-knee level in 174 ( 85.7 % ) .


Grafts were assessed by duplex ultrasound imaging and ankle-brachial indices performed postoperatively at discharge and at 30 days , 6 months , and 12 months .


The primary efficacy end point was primary patency of the study graft .


The primary safety end point was the composite of major adverse events and periprocedural death .


Secondary end points included the time to hemostasis of bleeding at the anastomotic suture hole and primary assisted and secondary patency .


The primary patency rates at 6 months were 86.4 % for the FUSION BIOLINE heparin-coated vascular graft group compared with 70.0 % for the standard ePTFE group , a difference of 16.4 % ( 95 % confidence interval , 2.7 % -29.9 % ; P = .006 ) , and the respective rates at 12 months were 76.5 % and 67.0 % ( 95 % confidence interval , -4.8 % to 23.0 % ; P = .05 ) .


The mean time to hemostasis of bleeding at the suture hole was 3.5 minutes in the FUSION BIOLINE group and 11.0 minutes in the standard ePTFE group ( P < .0001 ) .


Major adverse events were significantly lower in the FUSION BIOLINE group , occurring in 17.1 % , compared with 30.7 % in the standard ePTFE group ( P = .033 ) , principally a result of a lower rate of major graft reinterventions through 12 months in the FUSION BIOLINE group ( 16.2 % vs 30.7 % ) .


Data from this randomized multicenter study demonstrated improved midterm patency , less bleeding at the suture hole , and lower major adverse events with the FUSION BIOLINE heparin-coated vascular graft compared with standard ePTFE grafts .


Although the ultimate long-term benefit of the graft can not be ascertained with the data currently available , the utility of the FUSION BIOLINE vascular graft appears promising .


To describe the spectrum of cognitive outcomes of children with and without cerebral palsy ( CP ) after neonatal encephalopathy , evaluate the prognostic value of early developmental testing and report on school services and additional therapies .


The participants of this study are the school-aged survivors of the National Institute of Child Health and Human Development Neonatal Research Network randomized controlled trial of whole-body hypothermia .


Children underwent neurologic examinations and neurodevelopmental and cognitive testing with the Bayley Scales of Infant Development-II at 18 to 22 months and the Wechsler intelligence scales and the Neuropsychological Assessment-Developmental Neuropsychological Assessment at 6 to 7 years .


Parents were interviewed about functional status and receipt of school and support services .


We explored predictors of cognitive outcome by using multiple regression models .


Subnormal IQ scores were identified in more than a quarter of the children : 96 % of survivors with CP had an IQ < 70 , 9 % of children without CP had an IQ < 70 , and 31 % had an IQ of 70 to 84 .


Children with a mental developmental index < 70 at 18 months had , on average , an adjusted IQ at 6 to 7 years that was 42 points lower than that of those with a mental developmental index > 84 ( 95 % confidence interval , -49.3 to -35.0 ; P < .001 ) .


Twenty percent of children with normal IQ and 28 % of those with IQ scores of 70 to 84 received special educational support services or were held back 1 grade level .


Cognitive impairment remains an important concern for all children with neonatal encephalopathy .


A fiberglass short arm cast can be used to treat a distal radial fracture , but posttraumatic edema may lead to excessive cast tightness and resultant soft-tissue injury .


We sought to quantify a simulated edema-induced pressure within a fiberglass short arm cast and to determine the effectiveness of different cast-cutting methods for pressure reduction .


We hypothesized that cast cutting could eliminate all clinically relevant pressure and Ace wrap would insignificantly increase pressure .


Skin surface pressure under fiberglass short arm casts was measured on ninety wrists from forty-five volunteers randomly assigned to one cast-cutting method : single-cut ( cast bivalve and Ace wrap ) , double-cut ( cast bivalve , spread , and Ace wrap ) , or triple-cut ( cast bivalve , spread , Webril cut , and Ace wrap ) .


Each wrist was immobilized in a cast in the neutral position with one roll of 2-inch ( 5.1-cm ) cotton Webril and one roll of 2-inch ( 5.1-cm ) fiberglass .


Each fiberglass short arm cast contained an empty intravenous fluid bag in which we infused air .


This simulated edema , which generated a skin surface pressure , which was measured by a pressure transducer .


Each cast-cutting method significantly reduced ( p < 0.0001 ) the skin surface pressure from the average maximum of 92.5 mm Hg in a non-fracture setting .


Prior to Ace wrapping , there was a reduction in skin surface pressure of 70.8 % for the single-cut method , 85.1 % for the double-cut method , and 99.9 % for the triple-cut method .


Ace wrap significantly increased skin surface pressure ( p < 0.0001 ) , lessening the effectiveness of cast cutting .


There was an overall reduction in skin surface pressure of 55.9 % for the single-cut method , 64.3 % for the double-cut method , and 77.2 % for the triple-cut method .


Throughout our study , women had significantly higher skin surface pressure than men ( p < 0.0001 ) ; the average maximum was 104.4 mm Hg for women and 81.1 mm Hg for men .


The single-cut method provides the greatest pressure reduction , but only the triple-cut method eliminated all relevant skin surface pressure .


Ace wrapping a cut cast noticeably increased skin surface pressure .


In volunteers without a fracture , only the triple-cut method is effective enough to eliminate clinically relevant skin surface pressure .


Ace wrap should be applied with caution after the cast is cut .


The specific effect on pressure reduction in a patient who requires some soft-tissue pressure to maintain fracture reduction was not studied .


To observe the efficacy of Danzhi Xiaoyao Pill ( DXP ) in anovulation infertility patients with polycystic ovary syndrome ( PCOS ) of pathogenic fire derived from stagnation of Gan-qi ( PFDSG ) complicated insulin resistance ( IR ) .


Sixty PCOS patients were randomly assigned to two group , the integrative medical treatment group ( Group A ) and the Western medical treatment group ( Group B ) , 30 cases in each group .


All patients took Metformin and Diane-35 .


Those in Group A took DXP additionally .


The therapeutic course for all was 3 menstrual cycles .


After treatment the ovulation was induced by oral administration of letrozole or injection of menotropins ( HMG ) .


The therapeutic efficacy was compared between the two groups .


The levels of insulin , luteinizing hormone , and testosterone were obviously lower after treatment than before treatment in the two groups ( P < 0.05 ) .


There was no statistical difference between the two groups after treatment .


There was no statistical difference in body mass index ( BMI ) between the two groups before and after treatment ( P > 0.05 ) .


Better effects were obtained in Group A in improving symptoms such as agitation and irritability , fullness in the chest and hypochondrium , swollen pain in the breast before menstruation , bitter and dry mouth , oligomenorrhea , abnormal color and amount of menstruation , and pulse and tongue ( P < 0.05 , P < 0.01 ) .


The ovulation rate was 86.1 % ( 93/108 cases ) in Group A , obviously higher than that in Group B ( 65.5 % , 74/113 cases ) .


The clinical pregnancy rate was 60.0 % ( 18/30 cases ) in Group A , obviously higher than that in Group B ( 36.7 % , 11/30 cases ) , showing statistical difference ( P < 0.05 ) .


DXP could improve the ovulation rate and the pregnancy rate in anovulation infertility patients with PCOS complicated IR .


It also could significantly improve Chinese medical syndromes , showing obvious advantages over using Western medicine alone .


Thoracentesis is one of the bedside procedures most commonly associated with iatrogenic complications , particularly pneumothorax .


Various risk factors for complications associated with thoracentesis have recently been identified , including an inexperienced operator ; an inadequate or inexperienced support team ; the lack of a standardized protocol ; and the lack of ultrasound guidance .


We sought to determine whether ultrasound-guided thoracentesis can reduce the risk of pneumothorax and improve outcomes ( fewer procedures without fluid removal and greater volumes of fluid removed during the procedures ) .


In our comparison of thoracentesis with and without ultrasound guidance , all procedures were performed by a team of expert pulmonologists , using the same standardized protocol in both conditions .


A total of 160 participants were randomly allocated to undergo thoracentesis with or without ultrasound guidance ( n = 80 per group ) .


The primary outcome was pneumothorax following thoracentesis .


Secondary outcomes included the number of procedures without fluid removal and the volume of fluid drained during the procedure .


Pneumothorax occurred in 1 of the 80 patients who underwent ultrasound-guided thoracentesis and in 10 of the 80 patients who underwent thoracentesis without ultrasound guidance , the difference being statistically significant ( p = 0.009 ) .


Fluid was removed in 79 of the 80 procedures performed with ultrasound guidance and in 72 of the 80 procedures performed without it .


The mean volume of fluid drained was larger during the former than during the latter ( 960 500 mL vs. 770 480 mL ) , the difference being statistically significant ( p = 0.03 ) .


Ultrasound guidance increases the yield of thoracentesis and reduces the risk of post-procedure pneumothorax .


( Chinese Clinical Trial Registry identifier : ChiCTR-TRC-12002174 [ http://www.chictr.org/en/] ) .


To assess the efficacy of intra-articular sodium hyaluronate , administred once weekly for 3 weeks ( 3 injections ) in Moroccan patients with knee osteoarthritis over 6-month period .


We prospectively studied the outcome of 75 patients with painful knee osteoarthritis in grade 1 , 2 and 3 on ACR radiological criteria in our rheumatology clinic in Morocco .


Group 1 : 45 patients were treated with 3-weekly injections of intra-articular sodium hyaluronate ( 1 % ; 2,2-2 ,7 MDa ) .


Group 2 : 30 patients treated with symptomatic slow-acting drugs for osteoarthritis ( SYSADOA ) .


The efficacy parameters were Visual Analogue Scale ( VAS ) and Lequesne index .


In group 1 : 35/45 were female , a mean age of patients was 57.2 ( 8.2 ) years , and a mean Body Mass Index ( BMI ) was 28 ( 1.4 ) kg/m2 .


In group 2 : 23/30 were female , a mean age of patients was 58.6 ( 2.8 ) years , and a mean of BMI was 27.8 ( 1.4 ) kg/m2 .


Before treatment in group 1 , the mean of VAS was 6.5 cm ( 1 ) , and of Lequesne index 10.5 ( 2.1 ) .


At 3 and 6 months after the third injection of sodium hyaluronate , there was a significant improvement from baseline of Lequesne index and VAS ( P = 0.001 ) .


In group 2 before treatment , the mean of VAS was 7 cm ( 0,7 ) , and of Lequesne index 8 ( + 1.1 ) , but the improvement from baseline at 3 and 6 months of treatment was lower than group 1 .


The results of this prospective study , showed the efficacy of 3-weekly injections of sodium hyaluronate in the treatment of knee osteoarthritis in Moroccan patients over a 6-month period .


The aim of this study was to evaluate the effects of a standardized exercise program on sports enjoyment and leisure-time spending in adolescents with congenital heart disease and to know what the moderating impact of their baseline health behavior and disease knowledge is .


Included were 93 patients , aged 10 to 25 , with surgical repair for tetralogy of Fallot or with a Fontan circulation for single-ventricle physiology , of 5 participating centers of pediatric cardiology in The Netherlands .


They were randomly allocated , stratified for age , gender , and type of congenital heart disease to a 12-week period with either : ( 1 ) three times per week standardized exercise training or ( 2 ) care as usual ( randomization ratio 2:1 ) .


At baseline and after 12 weeks , participants completed Web-based questionnaires and were interviewed by phone .


Primary analyses tested changes from baseline to follow-up in sports enjoyment and leisure-time spending in the exercise group vs. control group .


Secondary analyses concerned the moderating influence of baseline health behavior and disease knowledge on changes from baseline to follow-up , and comparison with normative data .


At follow-up , the exercise group reported a decrease in passive leisure-time spending ( watching television and computer usage ) compared with controls .


Exercise training had no effect on sports enjoyment and active leisure-time spending .


Disease knowledge had a moderating effect on improvement in sports enjoyment , whereas health behavior did not .


Compared with normative data , patients obtained similar leisure time scores and lower frequencies as to drinking alcohol and smoking .


Exercise training decreased passive , but not active , leisure-time spending .


It did not influence sports enjoyment .


A recent randomized trial demonstrated that concurrent chemoradiotherapy ( CCRT ) with weekly cisplatin and gemcitabine , followed by two adjuvant cycles of cisplatin and gemcitabine improved survival for advanced cervical cancer patients .


An Asian Gynecologic Oncology Group ( AGOG ) study was designed to determine whether only adding gemcitabine in the chemoradiation phase without adjuvant chemotherapy could improve survival .


Between March 2009 and March 2013 , 74 eligible patients with International Federation of Obstetrics and Gynecology stage III/IVA cervical cancer or stage I/II with positive pelvic/para-aortic nodal metastasis were enrolled .


Thirty-seven patients were randomized to arm C ( weekly cisplatin 40mg/m ( 2 ) ) and 37 patients were randomized to arm CG ( weekly cisplatin 40mg/m ( 2 ) and gemcitabine 125mg/m ( 2 ) ) , for six cycles .


Six eligible patients were excluded before the beginning of treatment .


An interim analysis showed superimposable progression-free ( PFS ) and overall survival ( OS ) , a decision of closing accrual was made .


A 3-year PFS was similar in both arms ( arm C 65.1 % vs. arm CG 71.0 % , p = 0.71 ) , and a 3-year OS was 74.1 % in arm C vs. 85.9 % in arm CG ( p = 0.89 ) , but crossed over at 5years .


Grade 2-4 hematological toxicities , including neutropenia ( p = 0.028 ) and thrombocytopenia ( p = 0.001 ) , were more frequent in arm CG than arm C.


Despite limitation in power , it suggests that only adding gemcitabine at the CCRT phase does not provide substantially superior results , but treatment toxicities could increase .


Further studies are required to determine the role of post-CCRT adjuvant chemotherapy in advanced cervical cancer .


Coformulated elvitegravir , cobicistat , emtricitabine , and tenofovir disoproxil fumarate ( tenofovir ) might be a safe and efficacious switch option for virologically suppressed patients with HIV who have neuropsychiatric side-effects on a non-nucleoside reverse transcriptase inhibitor ( NNRTI ) or who are on a multitablet NNRTI-containing regimen and want a regimen simplification .


We assessed the non-inferiority of such a switch compared with continuation of an NNRTI-containing regimen .


STRATEGY-NNRTI is a 96 week , international , multicentre , randomised , open-label , phase 3b , non-inferiority trial enrolling adults ( 18 years ) with HIV-1 and plasma HIV RNA viral load below 50 copies per mL for at least 6 months on an NNRTI plus emtricitabine and tenofovir regimen .


With a computer-generated randomisation sequence , we randomly allocated participants ( 2:1 ; blocks of six , stratified by efavirenz use at screening ) to switch to coformulated elvitegravir , cobicistat , emtricitabine , and tenofovir ( switch group ) or continue the NNRTI plus emtricitabine and tenofovir regimen ( no-switch group ) .


Key eligibility criteria included no history of virological failure and an estimated glomerular filtration rate of 70 mL per min or greater .


The primary endpoint was the proportion of participants with plasma viral loads below 50 copies per mL at week 48 based on a snapshot algorithm with a non-inferiority margin of 12 % ( assessed by modified intention to treat ) .


This trial is ongoing and is registered at ClinicalTrials.gov , number NCT01495702 .


Between Dec 29 , 2011 , and Dec 13 , 2012 , we randomly allocated 439 participants to treatment : 290 participants in the switch group and 143 participants in the no-switch group received treatment and were included in the modified intention-to-treat population .


At week 48 , 271 ( 93 % ) of 290 participants in the switch group and 126 ( 88 % ) of 143 participants in the no-switch group maintained plasma viral loads below 50 copies per mL ( difference 53 % , 95 % CI -05 to 120 ; p = 0066 ) .


We detected no treatment-emergent resistance in either group .


Safety events leading to discontinuation were uncommon in both groups : six ( 2 % ) of 291 participants in the switch group and one ( 1 % ) of 143 in the no-switch group .


Coformulated elvitegravir , cobicistat , emtricitabine , and tenofovir seems to be efficacious and well tolerated in virologically suppressed adults with HIV and might be a suitable alternative for patients on an NNRTI with emtricitabine and tenofovir regimen considering a regimen modification or simplification .


Gilead Sciences .


To observe the effect of xuebijing Injection ( XI ) on perioperative coagulation and inflammatory reaction in senile patients receiving total hip arthroplasty ( THA ) .


Totally eighty patients receiving THA at Luoyang Orthopedics Hospital , 65 to 85 years old , were randomly assigned to the control group ( 40 cases ) and the treatment group ( 40 cases ) .


All patients received routine perioperative therapies .


Those in the treatment group received XI ( adding 50 mL XI in 100 mL normal saline , 30 min each time ) .


XI was continually injected after THA , twice daily for 3 successive days .


Blood samples were harvested on the morning of the 2nd admission day ( TO ) , immediately after operation ( T1 ) , on the morning of the 3rd day after operation ( T3 ) , and on the morning of the 5th day after operation ( T4 ) to detect prothrombin time ( PT ) , thrombin time ( TT ) , activated partial thromboplastin time ( APTT ) , levels of FIB and D-dimer ( D-D ) , changes of white blood cell ( WBC ) , neutrophils ( N ) , C-reactive protein ( CRP ) , erythrocyte sedimentation rate ( ESR ) , and IL-6 .


Complications of surgery were compared between the two groups .


There was no statistical difference in operation time , intraoperative blood loss , and blood transfusion between the two groups ( P > 0.05 ) .


Compared with TO in the same group , WBC , N , CRP , ESR , IL-6 , PT , TT , and D-D all increased in the control group at T1-T4 ( P < 0.05 ) ; APTT increased at T1-T2 ( P < 0.05 ) ; FIB increased at T1-T3 ( P < 0.05 ) .


WBC , N , IL-6 , PT , and D-D all increased in the treatment group at T1-T3 ( P < 0.05 ) ; CRP and ESR increased at T1-T4 ( P < 0.05 ) ; TT increased at T1-T2 ( P < 0.05 ) ; APTT and FIB increased at T1 ( P < 0.05 ) .


Compared with the control group at the same time period , WBC , N , CRP , and IL-6 all decreased in the treatment group at T1-T4 ( P < 0.05 ) , ESR decreased at T3-T4 ( P < 0.05 ) ; PT and TT decreased at T1-T3 ( P < 0.05 ) ; FIB and D-D decreased at T2-T4 ( P < 0.05 ) .


The occurrence of each complication was significantly lower in the treatment groups than in the control group .


XI could improve the perioperative high coagulation state of senile THA patients , inhibit inflammatory reactions , and reduce complications .


The purpose of this study was to evaluate the 5-year follow-up ( FU ) data of the THUNDER ( Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries ) .


The THUNDER trial was the first study to investigate the treatment of femoropopliteal arteries with a paclitaxel-coated balloon ( PCB ) .


In 154 patients , femoropopliteal arteries were treated with PCB , with angioplasty with paclitaxel in contrast medium , or no paclitaxel ( control ) .


The primary endpoint was 6-month late lumen loss ( LLL ) .


Secondary endpoints included freedom from target lesion revascularization ( TLR ) , binary restenosis rate , and amputation .


The 5-year FU compares outcomes in patients treated with PCB and control subjects .


Additionally , LLL at 6 months and TLR up to 5-year FU were analyzed in terms of sex and lesion length .


Over the 5-year period , the cumulative number of patients with TLR remained significantly lower in the PCB group ( 21 % ) than in the control group ( 56 % , p = 0.0005 ) .


In the small group of patients with angiographic and duplex sonographic follow-up , PCB was associated with a lower rate of binary restenosis ( 17 % vs. 54 % ; p = 0.04 ) .


No signs of aneurysm formation or constrictive fibrosis were detected .


Whereas LLL at 6-month FU did not differ between men and women in the PCB group , the TLR rate was lower in men than in women at 5-year FU .


A benefit of PCB treatment in terms of LLL and TLR was seen independent of lesion length .


The reduced TLR rate following PCB treatment was maintained over the 5-year FU period .


No signs of drug-related local vessel abnormalities were detected .


( Thunder Trial-Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries [ THUNDER ] ; NCT00156624 ) .


Evaluate efficacy/safety of olmesartan medoxomil ( OM ) / amlodipine ( AML ) / hydrochlorothiazide ( HCTZ ) in Hispanic/Latino adults with hypertension .


Randomized , double-blind , 12-week , parallel-group study followed by a 40-week open-label extension phase .


Clinical sites ( 317 ) in the United States and Puerto Rico .


Individuals > or = 18 years of age with mean seated blood pressure ( BP ) > or = 140/100 or > or = 160/90 mm Hg divided into Hispanic/Latino ( 369 ) and non-Hispanic/Latino ( 2122 ) subgroups .


Participants were randomized to OM 40/AML 10 mg , OM 40/HCTZ 25 mg , AML 10/HCTZ 25 mg , or OM 40/AML 10/HCTZ 25 mg during the double-blind phase .


During the open-label extension , all participants received OM 40/AML 5/HCTZ 12.5 mg ; participants not reaching BP goal within 2 weeks were randomly titrated to OM 40/AML 10/HCTZ 12.5 mg or OM 40/AML 5/HCTZ 25 mg , then to OM 40/AML 10 / HCTZ 25 mg after another 2 weeks .


Change in mean seated diastolic BP ( SeDBP ) from baseline ( double-blind phase ) .


Triple-drug therapy vs the dual therapies resulted in greater mean reduction in SeBP ( Hispanic/Latino : 35.0 / 20.9 mm Hg vs 27.8-30 .9 / 15.3-17 .7 mm Hg ; non-Hispanic/Latino : 39.0 / 21.7 mm Hg vs 28.9-31 .5 / 14.6-17 .8 mm Hg ) and enabled more participants to reach BP goal ( Hispanic/Latino : 56.8 % vs 40.6 % -51.2 % ; non-Hispanic/Latino : 65.7 % vs 33.8 % -46.6 % ) irrespective of ethnicity .


The efficacy of triple-drug therapy in achieving BP goal was sustained long-term ( 40-week open-label extension period ) in Hispanic/Latino ( 63.3 % ) and non-Hispanic / Latino ( 64.2 % ) participants .


Triple-drug therapy was well tolerated in Hispanic/Latino and non-Hispanic/Latino participants .


In this study , OM/AML/HCTZ was an effective treatment option in Hispanic / Latino patients with hypertension .


Schizophrenia is understood to be a heterogeneous brain condition with overlapping symptom dimensions .


The negative symptom dimension , with its protean cognitive manifestations , responds poorly to treatment , which can be a particular challenge in countries where clozapine therapy is not available .


Preliminary data indicate that minocycline may be beneficial adjunct in the treatment of schizophrenia : positive , negative , and cognitive symptoms.In this study we aim to assess the efficacy of adjunctive minocycline to alleviate symptoms of schizophrenia in patients who have failed to respond to a therapeutic trial of antipsychotic medications .


The study is a parallel group , double-blind , randomized , placebo-controlled trial .


Participants will be adults ( aged 18 years and above ) with first episode or relapse episode of schizophrenia of under 5 years ' duration .


Patients who failed to show adequate therapeutic response to at least one antipsychotic medication given for a minimum of 4 weeks will be recruited from a psychiatry hospital in Addis Ababa and a psychiatry clinic in Butajira , Ethiopia .


A total of 150 participants ( 75 in each arm ) will be required to detect a five-point mean difference between the intervention arms adjusting for baseline symptom severity , at 90 % power and 95 % confidence .


Patients in the intervention arm will receive minocycline ( 200 mg/day orally ) added on to the regular antipsychotic medications participants are already on .


Those in the placebo arm will receive an inactive compound identical in physical appearance to minocycline .


Intervention will be offered for 12 weeks .


Diagnosis will be established using the operational criteria for research ( OPCRIT ) .


Primary outcome measure will be a change in symptom severity measured using the positive and the negative syndrome scale for schizophrenia ( PANSS ) .


Secondary outcome measures will include changes in severity of negative symptoms , proportion achieving remission , and level of functioning .


Whether changes are maintained post intervention will also be measured ( PANSS ) .


Key assessment for the primary outcome will be conducted at the end of trial ( week 12 ) .


One post-intervention assessment will be conducted 4 weeks after the end of intervention ( week 16 ) to determine sustainability of change .


Clinicaltrials.gov identifier : NCT01809158 .


Owing to the great absorption capability of the pleura for transudates , the protein content of draining pleural fluid may be considered as a more adequate determinant than its daily draining amount in the decision-making for earlier chest tube removal .


In an a priori pilot study , we observed that the initially draining protein-rich exudate converts to a transudate quickly in most patients after lobectomies .


Thus , chest tubes draining high-volume but low-protein fluids can safely be removed earlier in the absence of an air leak .


This randomized study aims to investigate the validity and clinical applicability of this hypothesis as well as its influence on the timing for chest tube removal and earlier discharge after lobectomy .


Seventy-two consecutive patients undergoing straightforward lobectomy were randomized into two groups .


Patients with conditions affecting postoperative drainage and with persisting air leaks beyond the third postoperative day were excluded .


Drains were removed if the pleural fluid to blood protein ratio ( PrRPl/B ) was 0.5 , regardless of its daily draining amount in the study arm ( Group S ; n = 38 ) , and patients in the control arm ( Group C ; n = 34 ) had their tubes removed if daily drainage was 250 ml regardless of its protein content .


Patients were discharged home immediately or the following morning after removal of the last drain .


All cases were followed up regarding the development of symptomatic pleural effusions and hospital readmissions for a redrainage procedure .


Demographic and clinical characteristics as well as the pattern of decrease in PrRPl/B were the same between groups .


The mean PrRPl/B was 0.65 and 0.67 ( 95 % CI = 0.60-0 .69 and 0.62-0 .72 ) on the first postoperative day , and it remarkably dropped down to 0.39 and 0.33 ( 95 % CI = 0.33-0 .45 and 0.27-0 .39 ) on the second day in Groups S and C , respectively , and remained below 0.5 on the third day ( repeated-measures of ANOVA design , post hoc ` within-group ' comparison of the first postoperative day versus second and third days ; P < 0.002 ) .


Eleven of 38 ( 29 % ) and 16 of 27 ( 59 % ) patients ' chest tubes were , respectively , removed on the first and second postoperative days in Group S , but only two of 34 ( 6 % ) and ten of 32 ( 31 % ) patients , respectively , had their chest tubes removed in Group C ( two-tailed Fisher 's exact test , P = 0.02 and 0.005 for the first and the second postoperative days , respectively ) .


On the third postoperative day , daily drainage remained 250 ml in 22 ( 65 % ) patients , among whom , 17 ( 77 % ) would have their chest tubes removed on the PrRPl/B value in Group C. However , drains could not be removed due to the high protein content of draining fluid despite the acceptable volume of daily drainage in only three ( 27 % ) of 11 cases in Group S ( McNemar 's paired proportions test , P = 0.009 ) .


The mean chest tube removal time ( 2.1 0.9 vs 2.9 1.0 days ; P < 0.001 ) and the median hospital stay [ 3 days ( IQR : 1-3 ) vs 4 days ( IQR : 2-4 ) , P < 0.003 ] were significantly shorter in Group S. None of the patients required a redrainage procedure due to a persistent and symptomatic pleural effusion .


Regardless of the daily drainage , chest tubes can safely be removed earlier than anticipated in most patients after lobectomy if the protein content of the draining fluid is low .


Phosphodiesterase type-5 inhibitors ( PDE5Is ) are first-line therapies for erectile dysfunction ( ED ) .


Sildenafil ( SIL ) and vardenafil ( VAR ) are approved for as-needed ( PRN ) dosing ; tadalafil ( TAD ) is approved for both PRN and once-a-day ( OaD ) dosing for ED .


Recent evidence suggests that TAD-OaD may be effective as therapy in men with an incomplete response to PRN-PDE5I therapy .


This study evaluated whether TAD-OaD provides similar efficacy in men with ED who had previously demonstrated a partial response to PRN-PDE5I therapy .


In this randomized , double-blind , placebo-controlled trial , men with a 3 month ED history received SIL 100mg , TAD 20mg , or VAR 20mg during a 4 week open-label lead-in period .


Those with International Index of Erectile Function - Erectile Function ( IIEF-EF ) domain scores < 26 following lead-in treatment completed a 4 week washout period , then randomized to TAD 2.5 mg up-titrated to 5mg , TAD 5mg , or placebo ( PBO ) OaD for 12 weeks .


MAIN OUTCOME MEASURES obtained from patients treated with TAD-OaD were compared to PBO-treated patients .


Additionally , results of treatment with TAD-OaD were compared to results obtained from 4 week PRN-PDE5I therapy to determine whether OaD and PRN regimens provided comparable efficacy .


NCT01130532 .


International Index of Erectile Function ( IIEF ) domain scores ; Sexual Encounter Profile ( SEP ) questions 2-5 .


Endpoint data was obtained from 590 men ( 391 TAD ; 199 PBO ) .


RESULTS for all IIEF and SEP measures were significantly better for TAD-OaD ( p < 0.001 for all ) compared to PBO and were comparable to those observed during PRN-PDE5I treatment .


TAD 2.5 mg and TAD 5mg OaD therapy were safe and generally well tolerated .


Tadalafil once daily is a viable alternative to as-needed PDE5I therapy in men with ED .


Key limitations include the lack of a PRN PDE5I study group during the double-blind period , and that many more patients took tadalafil than sildenafil or vardenafil during the PRN period .


Hepatic encephalopathy ( HE ) is associated with a poor prognosis in patients with advanced liver disease .


Probiotics alter the intestinal microbiota with non-urease-producing organisms that reduce production of ammonia .


We investigated the efficacy of probiotics for the primary prophylaxis of HE .


We conducted a prospective trial at a tertiary care referral institute in New Delhi , India , from January 2012 through March 2013 , of patients with cirrhosis without overt HE ( age , 48.6 11.1 y ; 96 men and 64 women ) ; 25 were Child-Turcotte-Pugh ( CTP ) class A , 51 were CTP class B , and 84 were CTP class C. Subjects were assigned randomly to groups given probiotics ( 1 10 ( 8 ) colony-forming units , 3 times daily ; n = 86 , 42 with minimal HE ) or no test article ( control , n = 74 ; 33 with minimal HE ) .


All subjects underwent psychometric analyses , critical flicker fusion ( CFF ) threshold assessments , glucose hydrogen breath tests to identify small intestinal bacterial overgrowth ( SIBO ) , and lactulose hydrogen breath tests to measure orocecal transit time ( OCTT ) .


The primary end point was the development of overt HE .


At baseline , subjects in each group had comparable CTP score , model for end-stage liver disease scores , CFF assessments , psychometric hepatic encephalopathy scores , and OCTT .


After a mean follow-up period of 38.6 8.80 weeks for patients given probiotics and 40.3 9.8 weeks for controls , 6 patients given probiotics and 7 controls died ( P = .81 ) .


Three months of probiotic administration significantly reduced levels of arterial ammonia , SIBO , and OCTT ; increased psychometric hepatic encephalopathy scores ; and increased CFF thresholds , compared with baseline .


Seven subjects in the probiotic group and 14 controls developed overt HE ( P < .05 ; hazard ratio for controls vs probiotic group , 2.1 ; 95 % confidence interval , 1.31-6 .53 ) .


Psychometric hepatic encephalopathy scores , CTP scores , and SIBO correlated with the development of overt HE .


In a prospective , randomized controlled trial , probiotics were found to be effective in preventing HE in patients with cirrhosis .


Trial registration No : CTRI/2012/07 / 002807 .


We sought to compare weight loss in the first 6 weeks postpartum among women with gestational diabetes mellitus ( GDM ) treated with metformin or placebo , a promising therapy to reduce later risk of progression to diabetes mellitus .


We conducted a pilot , randomized trial of metformin vs placebo in postpartum women with GDM .


Women with pre-GDM , unable to tolerate metformin , resumed on insulin or oral hypoglycemic agent , delivered < 34 weeks ' gestation , or with a body mass index < 20 kg/m ( 2 ) were excluded .


Women were randomized to either metformin 850 mg daily for 7 days , then metformin 850 mg twice a day for the next 5 weeks or placebo prescribed in a similar frequency .


The subject , health care provider , and research staff were blinded to the treatment .


The primary outcome was weight change from delivery to 6 weeks postpartum .


Secondary outcomes included the percentage of women achieving their self-reported prepregnancy weight , reported medication adherence , adverse effects , and satisfaction .


Differences in weight change between groups were determined by Wilcoxon rank sum test and in achieving prepregnancy weight by ( 2 ) test .


Of 114 women randomized , 79 ( 69.3 % ) completed the 6 weeks ; 36 ( 45.6 % ) were randomized to metformin and 43 ( 54.4 % ) to placebo .


Metformin and placebo groups were similar in median weight loss ( 6.3 kg [ range , -0.3 to 19.8 ] vs 6.5 kg [ range , -0.3 to 12.1 ] , P = .988 ) and percentage of women achieving reported prepregnancy weight ( 41.7 vs 37.2 % , P = .69 ) .


Self-reported adherence in taking > 50 % of medication was 75 % at 3 weeks and 97 % at 6 weeks .


Nausea , diarrhea , and hypoglycemia were reported in approximately 11-17 % of women and 56-63 % reported dissatisfaction with the medication .


Women with GDM lost approximately 6 kg by 6 weeks ' postpartum .


This was similar in both groups and resulted in < 50 % of women achieving their prepregnancy weight .


Although the reported adherence and satisfaction with the medication was high , adverse effects were reported with nearly 1 in 5 women including nausea , diarrhea , and hypoglycemia .


Contrary to expectation , we found no evidence of benefit from metformin .


However , longer treatment periods and larger studies with minimal attrition may be warranted .


Prophylactic use of fresh frozen plasma ( FFP ) in critically ill patients with a coagulopathy is common .


However , a lack of evidence of efficacy has resulted in a call for trials on the benefit of FFP in these patients .


To date , conducting a trial on this subject has not been successful .


Recently , a multi-center randomised trial was stopped prematurely due to slow inclusion .


To assess clinicians ' opinions regarding a trial on prophylactic administration of FFP in coagulopathic critically ill patients who need to undergo an intervention .


A survey among 55 intensivists who all participated in a randomised trial on the risks and benefits of FFP in critically ill patients .


Response rate was 84 % .


Majority of respondents indicated that international normalised ratio ( INR ) should be assessed before insertion of a central venous catheter ( CVC ) ( 61 % ) , chest tube ( 89 % ) or tracheostomy ( 91 % ) .


Reasons to withhold transfusion of FFP to non-bleeding critically ill patients are risk of transfusion-related acute lung injury ( TRALI ) ( 46 % ) , fluid overload ( 39 % ) and allergic reaction ( 24 % ) .


Although , the majority of respondents expressed the opinion that the trial was clinically relevant , 56 % indicated that 1 patient subgroups should have been excluded from participation .


Intensivists express the need for more evidence on the prophylactic use of FFP in coagulopathic critically ill patients .


However , lack of knowledge about FFP and personal beliefs about the preferable transfusion strategy among clinicians , resulted in premature termination of a clinical trial on this topic .


The rate of adherence to regular colonoscopy screening in individuals at increased familial risk of colorectal cancer ( CRC ) is suboptimal , especially among rural and other geographically underserved populations .


Remote interventions may overcome geographic and system-level barriers .


We compared the efficacy of a telehealth-based personalized risk assessment and communication intervention with a mailed educational brochure for improving colonoscopy screening among at-risk relatives of patients with CRC .


Eligible individuals age 30 to 74 years who were not up-to-date with risk-appropriate screening and were not candidates for genetic testing were recruited after contacting patients with CRC or their next of kin in five states .


Enrollees were randomly assigned as family units to either an active , personalized intervention that incorporated evidence-based risk communication and behavior change techniques , or a mailed educational brochure .


The primary outcome was medically verified colonoscopy within 9 months of the intervention .


Of the 481 eligible and randomly assigned at-risk relatives , 79.8 % completed the outcome assessments within 9 months ; 35.4 % of those in the personalized intervention group and 15.7 % of those in the comparison group obtained a colonoscopy .


In an intent-to-treat analysis , the telehealth group was almost three times as likely to get screened as the low-intensity comparison group ( odds ratio , 2.83 ; 95 % CI , 1.87 to 4.28 ; P < .001 ) .


Persons residing in rural areas and those with lower incomes benefitted at the same level as did urban residents .


Remote personalized interventions that consider family history and incorporate evidence-based risk communication and behavior change strategies may promote risk-appropriate screening in close relatives of patients with CRC .


In the ongoing GEnotipo , Fenotipo y Ambiente de la HiperTensin Arterial en UruguaY ( GEFA-HT-UY ) study , we applied standardized epidemiological methods to determine complex phenotypes including blood pressure ( BP ) .


In this report , we present the quality control of the conventionally measured BP .


Three trained observers measured BP five times consecutively in the seated position at each of two home visits and one clinic visit according to the guidelines of the European Society of Hypertension .


On 1 December 2013 , 4379 single BP readings in 170 participants were available for analysis .


Fewer BP readings than the five planned per contact occurred only at one home visit .


Among observers , the frequency of identical consecutive readings for systolic or diastolic BP varied from 0 to 4.2 % .


The occurrence of odd readings ranged from 0.1 to 0.6 % .


Only 21.6 % of the systolic and diastolic BP readings ended on zero ( expected 20 % ) .


At home visits , there was a progressive decline in BP from the first to the fifth reading .


The average of the five BP readings also decreased from the first to the second home visit ( -5.63 / -2.34 mmHg ) .


Our study highlighted the necessity to implement a stringent quality control of the conventionally measured BP .


The procedures set up in the GEFA-HT-UY study are resulting in a well-defined BP phenotype , which is consistent with that in other population studies .


The purpose of this study was to determine whether 400 g/kg oral ivermectin is able to kill Ixodes scapularis nymphs and adult female ticks feeding on humans .


Ten study subjects each wore 2 ostomy bags , the one containing 24 I scapularis nymphs , and the other containing 24 I scapularis adult females .


Twenty-four hours after the ostomy bags were attached , study subjects received either 400 g/kg ivermectin or placebo .


Thirty hours after the ivermectin or placebo was consumed , the ticks were removed , and mortality determined in a double-blinded manner .


Eleven percent of the I scapularis nymphs attached in the ivermectin group compared with 17 % in the placebo .


Mortality for the I scapularis nymphs that attached at the time of removal was 55 % in the ivermectin group and 47 % in the placebo group .


Mortality for the I scapularis nymphs 5 days after removal was 92 % in the ivermectin group and 88 % for the placebo .


Three percent of the I scapularis adults attached in the ivermectin group compared with 9 % in the placebo group .


Mortality for I scapularis adults was 0 % on day 3 and 33 % on day 8 for both the ivermectin and placebo groups .


There were statistically insignificant differences in the mortality rates between I scapularis nymphs and adults exposed to ivermectin or placebo .


There were a high number of ticks that died in both groups but the data do not support our hypothesis that ivermectin can kill I scapularis .


The study was not designed to determine whether it could prevent the transmission of tick-borne illness .


The goal was to investigate the effects of Brain Wave Vibration ( BWV ) , a meditation practised in a class involving rhythmic movements of the head , neck and body practised with related yoga-style exercises , and to isolate the rhythmic effects .


A randomised controlled trial was conducted with assessments pre - and post-trial and immediately before and after each session .


Thirty-one healthy adults were assessed for mood , sleep , mindfulness , health and well-being , and pre - and post-class activation-deactivation .


Participants were randomly assigned to either BWV in toto or a control group having similar yoga exercises without the rhythmic components .


Participants completed eight to twelve 75-min classes of BWV or control training over 8-12 weeks .


To control for expectation participants were told only that the aim was to compare two subtly different styles of Korean yoga .


The BWV group had comparatively greater improvements in sleep duration and efficiency , although they had higher baseline inefficiency , and post-trial they had better global sleep and well-being and fewer illness symptoms , and better tiredness and energy post-class .


Both groups benefitted in mood , mindfulness and vitality post-trial with improved tension and calmness post-class .


The participants of both interventions had better mood and well-being on the whole following the trial and were more relaxed immediately after a class .


However , BWV training was unique in its benefits to sleep , health , well-being , energy and tiredness , warranting further research .


To assess the efficacy of a hypotensive prophylactic medication in preventing intraocular pressure ( IOP ) changes after intravitreal injections , and the effect of occurrence of vitreous reflux on the variation of IOP .


A total of 141 intravitreal injections of anti-vascular endothelial growth factor drugs ( 0.05 mL ) were randomly distributed into 2 groups : in group 1 ( n = 77 ) , no prophylactic IOP-lowering medication was used ; in group 2 ( n = 64 ) , a fixed combination of brimonidine and timolol was instilled 5 minutes before the injection .


The IOP was measured before and 1 , 15 , and 30 minutes after the injection .


The presence of vitreous reflux was recorded .


Despite significantly reducing the IOP by ~ 3 mm Hg , prophylactic medication did not prevent a transient IOP rise .


A total of 22.7 % of injections showed vitreous reflux , and those patients experienced much lower initial spikes .


Indeed , only 6.5 % out of 77 injections above 30 mm Hg within 1 minute after injection showed vitreous reflux .


Only one case showed an IOP > 30 mm Hg at 15 minutes , and none at 30 minutes postinjection .


The IOP normalization rates over time were similar in all groups within 15 minutes .


Prophylactic medication instilled 5 minutes before the injection was not effective in preventing a pressure rise after intravitreal injections .


Vitreous reflux decreased significantly the spike figures compared to injections with no reflux .


To explore the anesthetic effect of preemptive analgesia of frequency acupoint electrical stimulation on painless-induced abortion as well as its effect on anesthetics dosage .


Ninety cases of early pregnancy who selected painless-induced abortion were randomly divided into two groups , 45 cases in each group .


Frequency acupoint electrical stimulation at Ciliao ( BL 32 ) and Shenshu ( BL 23 ) , disperse-densewave , 2 Hz/100 Hz in frequency for 15 to 20 min , was applied in the group A , which was followed by intravenous anesthesia of propofol .


The intravenous anesthesia of propofol was applied in the group B.


The blood pressure ( BP ) , heart rate ( HR ) and SpO2 before , during and after surgery , anesthetic effect and dosage , waking time and adverse events were observed in the two groups .


The BP and HR during and after the surgery in the group A were not statistically different from those before the surgery ( all P > 0.05 ) .


The BP was reduced and HR was slowed down during the surgery in the group B , which was significantly different from those before the surgery as well as those in the group A ( all P < 0.05 ) .


The dosage of propofol was ( 114.3 - +6.1 ) mg in the group A. obviously less than ( 193.2 + / - 8.9 ) mg in the group B ( P < 0.05 ) .


The waking time was ( 5.6 + / - 1.2 ) min in the group A , obviously less than ( 10.1 + / - 3.9 ) min in the group B ( P < 0.05 ) .


As for anesthetic effect , the incidence of Grade I in the group A was more than the group B ( P < 0.05 ) .


The adverse events , including nausea , vomiting and contractions pain in the group A were evidently less than those in the group B ( all P < 0.05 ) .


The preemptive analgesia of frequency acupoint electrical stimulation could significantly improve anesthetic effect of painless-induced abortion , reduce dosage of anesthetics , shorten waking time of surgery and guarantee the safety of surgery .


Attentional retraining ( AR ) is a potential new treatment for addiction .


AR trains addicts to attend away from drug-related cues , thereby reducing exposure to drug cues and reducing craving .


We examined the utility of delivering AR to smokers on a personal digital assistant ( PDA ) in the natural environment .


Smokers ( N = 60 ) not seeking to quit were randomly assigned to an AR group or a control group ( i.e. , a group with no training ) .


They carried a PDA with them for one week .


They were prompted to complete four assessments daily , including three attentional retrainings ( AR group ) or three control trainings ( control group ) , and one evaluation of attentional bias .


AR was implemented using a modified visual probe task .


Attentional bias was assessed using a standard visual probe task on the PDA .


The AR group completed an average of 15.0 attentional retrainings and the control group completed an average of 14.9 control trainings .


As hypothesized , attentional bias declined over the week in the AR group , but not in the control group , Group Day interaction , F ( 1 , 232 ) = 4.77 , p = .03 .


AR also reduced craving ratings following a briefly presented picture containing smoking and nonsmoking features , group main effect , F ( 1 , 234 ) = 3.89 , p = .04 .


AR did not significantly influence smoking behavior .


AR can be administered on a mobile device in the natural environment , and AR can reduce attentional bias and craving .


Complicated grief ( CG ) is a debilitating condition , most prevalent in elderly persons .


However , to our knowledge , no full-scale randomized clinical trial has studied CG in this population .


To determine whether complicated grief treatment ( CGT ) produces greater improvement in CG and depressive symptoms than grief-focused interpersonal psychotherapy ( IPT ) .


Randomized clinical trial enrolling 151 individuals 50 years or older ( mean [ SD ] age , 66.1 [ 8.9 ] years ) scoring at least 30 on the Inventory of Complicated Grief ( ICG ) .


Participants were recruited from the New York metropolitan area from August 20 , 2008 , through January 7 , 2013 , and randomized to receive CGT or IPT .


The main outcome was assessed at 20 weeks after baseline , with interim measures collected at 8 , 12 , and 16 weeks after baseline .


Sixteen sessions of CGT ( n = 74 ) or IPT ( n = 77 ) delivered approximately weekly .


Rate of treatment response , defined as a rating from an independent evaluator of much or very much improved on the Improvement subscale of the Clinical Global Impression Scale .


Both treatments produced improvement in CG symptoms .


Response rate for CGT ( 52 individuals [ 70.5 % ] ) was more than twice that for IPT ( 24 [ 32.0 % ] ) ( relative risk , 2.20 [ 95 % CI , 1.51-3 .22 ] ; P < .001 ) , with the number needed to treat at 2.56 .


Secondary analyses of CG severity and CG symptom and impairment questionnaire measures confirmed that CGT conferred a significantly greater change in illness severity ( 22 individuals [ 35.2 % ] in the CGT group vs 41 [ 64.1 % ] in the IPT group were still at least moderately ill [ P = .001 ] ) , rate of CG symptom reduction ( 1.05 ICG points per week for CGT vs 0.75 points per week for IPT [ t633 = 3.85 ; P < .001 ] ) , and the rate of improvement in CG impairment ( 0.63 work and Social Adjustment Scale points per week with CGT and 0.39 points per week with IPT [ t503 = 2.87 ; P = .004 ] ) .


Results were not moderated by participant age .


Complicated grief treatment produced clinically and statistically significantly greater response rates for CG symptoms than a proven efficacious treatment for depression ( IPT ) .


Results strongly support the need for physicians and other health care providers to distinguish CG from depression .


Given the growing elderly population , the high prevalence of bereavement in aging individuals , and the marked physical and psychological impact of CG , clinicians need to know how to treat CG in older adults .


clinicaltrials.gov Identifier : NCT01244295 .


To evaluate the clinical application of a dosing algorithm by genotypes in prediction of warfarin maintenance dose in Chinese patients with pulmonary thromboembolism .


During October 2010 and August 2012 , 220 inpatients or outpatients with pulmonary embolism in Beijing Anzhen Hospital , were enrolled by the inclusion criteria .


The patients included 86 males and 134 females .


The clinical data and blood samples were collected .


The fluorescent PCR genotyping method was used to detect the genotypes of vitamin K epoxy compounds reductase complex subunit 1 ( VKORC1 ) and cytochrome P450 enzyme 2C9 ( CYP2C9 ) .


According to the random number table , the patients were randomly divided into a study group and a control group .


In the study group , the first 3 doses of warfarin were prescribed according to the predicted warfarin dose , while in the control group the drug was prescribed according to the dose estimated empirically by clinicians .


Warfarin was adjusted until it reached a stable dose according to the INR value , and the following-up lasted for 50 days .


AT the end of follow-up , the percentage of patients who obtained a stable dose in the study group and the control group was 82.1 % ( n = 78 ) and 66 % ( n = 64 ) , respectively .


The mean time to reach a stable dose in the study group and the control group was ( 16.8 1.5 ) and ( 25.6 1.8 ) days , and the median time was ( 11.0 1.0 ) days and ( 20.0 2.0 ) days , the difference between the 2 groups being statistically significant ( ( 2 ) = 18.175 , P < 0.001 ) .


The incidence of side effects of the study group was lower than that of the control group , and the time to the occurrence of side effects in study group was longer .


The average predicted dose of the 142 patients who reached a stable dose was ( 3.6 0.9 ) mg/d , and the average effective dose was ( 3.7 1.3 ) mg/d , the average predicted dose being lower than the actual dose ( 0.1 1.2 ) mg/d , but the difference was not significant ( t = -1.202 , P > 0.05 ) .


The warfarin stable dose prediction algorithm , containing genetic factors and non-heritage factors , can significantly shorten the adjustment time to reach warfarin stable dose , and reduce the incidence of side effects , and is clinically applicable .


It has been suggested that magnesium deficiency is associated with the triggering of acute phase response , which may contribute to type 2 diabetes and cardiovascular disease risk .


We undertook this study to determine whether oral magnesium supplementation modifies serum levels of high-sensitivity C-reactive protein ( hsCRP ) in apparently healthy subjects with prediabetes and hypomagnesemia .


A total of 62 men and non-pregnant women aged 18-65 year , with new diagnosis of prediabetes ( glucose 5.6 < 7.0 mmol/L and/or post-load glucose 7.7 < 11.1 mmol/L ) and hypomagnesemia ( serum magnesium levels < 0.74 mmol/L ) were enrolled in a clinical double-blind placebo-controlled trial and randomly allocated to receive either magnesium chloride ( 30 mL of MgCl2 5 % solution ) or NaHCO3 0.1 % solution , once daily for 3 months .


At basal conditions , anthropometric and biochemical variables were similarly distributed in both groups .


At the end of follow-up , participants who received magnesium chloride showed higher serum magnesium levels ( 0.86 0.08 vs. 0.69 0.16 mmol/L , p = 0.002 ) and lower hsCRP levels ( 4.8 15.2 vs. 17.1 21.0 nmol/L , p = 0.01 ) compared with participants in the control group .


Oral magnesium supplementation decreases hsCRP levels in apparently healthy subjects with prediabetes and hypomagnesemia .


Chronic low back pain ( cLBP ) is a significant public health problem , being the primary cause of work absenteeism , as well as affecting sufferers ' quality of life , in industrialized society .


International guidelines recommend intensive multidisciplinary approaches for patients with cLBP .


However , these costly and time-consuming programs can only be offered to a minority of the most heavily affected patients and therefore do not seem likely to respond to public health requirements .


Lighter programs may be an alternative to full time hospital-based programs with valuable results in terms of disability and occupational activity for cLBP patients .


It is therefore important to define both what the determining components of management to improve activity restriction are and how to treat a larger number of patients more effectively at a lower cost .


The aim of this study is to compare three programs with various levels of intensity and multidisciplinary .


This paper describes the protocol for a prospective , randomized , controlled , clinical trial in working aged patients with cLBP .


Three treatment strategies are compared : ( 1 ) intensive and multidisciplinary program conducted in a rehabilitation center ; ( 2 ) less intensive outpatient program conducted by a private physiotherapist ; ( 3 ) mixed strategy combining the same out program with a multidisciplinary intervention .


The primary outcome of the trial is the impact of the mixed strategy on being able to work compared to hospital centered-program and out program .


The secondary outcome is the impact of the mixed strategy on quality of life and social ability compared to the two others programs .


The intervention part of the trial programs will take 5 weeks and observational follow-up will take 12 months .


The sample size will be 180 participants ( 60 for each arm ) .


The project has been approved by the Ethical Committee of Angers Hospital , France .


On the hypothesis that a multidisciplinary approach is the key feature to programs success in reducing social and occupational impairment in cLBP patients , we suggest that it is possible to achieve the same results with less intensive strategies if a multidisciplinary approach is maintained .


Current Controlled Trials NCT02030171 .


To compare the safety and efficacy of isotonic versus hypotonic maintenance fluid in children .


Randomized controlled trial .


Tertiary-level teaching hospital .


60 children ( age 0.5 to 12 years ) who were admitted and anticipated to receive intravenous fluid for the next 48 hours .


Hypotonic fluid ( Standard maintenance volume as 0.18 % NaCl in 5 % dextrose ) or Isotonic fluid ( 60 % Standard maintenance volume as 0.9 % NaCl solution in 5 % dextrose ) .


Primary : Incidence of hyponatremia .


Secondary : Serum sodium , serum osmolality , blood sugar , blood urea , serum creatinine , serum potassium , serum chloride , pH , urine output , change in weight , morbidity and death .


At 24 hours , hyponatremia was noted in 7 ( 24 % ) patients in the isotonic and 16 ( 55 % ) in hypotonic group ( P = 0.031 ) .


At 48 hours , hyponatremia was noted in 4 ( 14 % ) and 13 ( 45 % ) patients in isotonic and hypotonic group , respectively ( P = 0.02 ) .


There was significant change in sodium levels in both isotonic ( P = 0.036 ) and hypotonic ( P < 0.001 ) intervention groups .


The peak fall in mean serum sodium level was noted at 24 hours ( -6.5 , 95 % CI : -3.5 , -9.6 mEq/L ; P < 0.001 ) in hypotonic group .


In isotonic group , there was significant increase between 24 and 48 hours ( 4.3 , 95 % CI : 0.1 , 8.4 mEq/L ; P = 0.04 ) .


Reduced volume isotonic fluid results in fewer episodes of hyponatremia than hypotonic fluid in sick children during the first 48 hours of intravenous fluid therapy .


In the current study , we compared measures of treatment outcome and engagement for Latino and non-Latino White patients receiving a cognitive behavioral therapy ( CBT ) program delivered in primary care .


Participants were 18-65 years old and recruited from 17 clinics at 4 different sites to participate in a randomized controlled trial for anxiety disorders , which compared the Coordinated Anxiety Learning and Management ( CALM ) intervention ( consisting of CBT , medication , or both ) with usual care .


Of those participants who were randomized to the intervention arm and selected CBT ( either alone or in combination with medication ) , 85 were Latino and 251 were non-Latino White ; the majority of the Latino participants received the CBT intervention in English ( n = 77 ) .


Blinded assessments of clinical improvement and functioning were administered at baseline and at 6 , 12 , and 18 months after baseline .


Measures of engagement , including attendance , homework adherence , understanding of CBT principles , and commitment to treatment , were assessed weekly during the CBT intervention .


Findings from propensity-weighted linear and logistic regression models revealed no statistically significant differences between Latinos and non-Latino Whites on symptom measures of clinical improvement and functioning at almost all time points .


There were significant differences on 2 of 7 engagement outcomes , namely , number of sessions attended and patients ' understanding of CBT principles .


These findings suggest that CBT can be an effective treatment approach for Latinos who are primarily English speaking and likely more acculturated , although continued attention should be directed toward engaging Latinos in such interventions .


To investigate the clinical effects of modified dachengqi tang ( DCQT ) on promoting gastrointestinal motility in post-operative esophageal cancer patients .


Sixty postoperative esophageal cancer patients were enrolled and randomly assigned to the modified treatment group or the control group ( 30 patients in each group ) .


Patients in the treatment group were given DCQT made from decocted herbs and administered via nasojejunal tube at a dosage of 150 mL .


Gastrointestinal motility was assessed by recording time for recovery of bowel sounds , flatus , defecation , and the total amount of gastric drainage during the first three postoperative days .


Plasma motilin ( MTL ) and vasoactive intestinal peptide ( VIP ) were measured one hour before and three days after surgery .


Compared with the control group , the times to first bowel sound , flatus , and defecation were significantly shorter and there was less gastric drainage in the treatment group ( P < 0.01 , P < 0.01 , P < 0.01 , and P < 0.05 , respectively ) .


In the treatment group , postoperative plasma MTL was significantly higher ( P < 0.01 ) and VIP was significantly lower than those in the control group ( P < 0.05 ) .


There was no difference found in either MTL or VIP from before to after operation in the treatment group ( P > 0.05 ) .


MTL was significantly lower and VIP was higher postoperatively in the control group , compared to before surgery ( P < 0.01 ) .


Modified DCQT effectively improved decreased gastrointestinal motility in postoperative esophageal cancer patients by increasing MTL and reducing VIP .


Critically ill patients with respiratory failure undergoing bronchoscopy have an increased risk of hypoxaemia-related complications .


Previous studies have shown that in awake , hypoxaemic patients non-invasive ventilation ( NIV ) is helpful in preventing gas exchange deterioration during bronchoscopy .


An alternative and increasingly used means of oxygen delivery is its application via high-flow nasal cannula ( HFNC ) .


This study was conducted to compare HFNC with NIV in patients with acute hypoxaemic respiratory failure undergoing flexible bronchoscopy .


Prospective randomised trial randomising 40 critically ill patients with hypoxaemic respiratory failure to receive either NIV or HFNC during bronchoscopy in the intensive care unit .


After the initiation of NIV and HFNC , oxygen levels were significantly higher in the NIV group compared to the HFNC group .


Two patients were unable to proceed to bronchoscopy after the institution of HFNC due to progressive hypoxaemia .


During bronchoscopy , one patient on HFNC deteriorated due to intravenous sedation requiring non-invasive ventilatory support .


Bronchoscopy was well tolerated in all other patients .


There were no significant differences between the two groups regarding heart rate , mean arterial pressure and respiratory rate .


Three patients in the NIV group and one patient in the HFNC group were intubated within 24 hours after the end of bronchoscopy ( P = 0.29 ) .